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an electrical method and apparatus for stimulating cardiac cells causing contraction to force hemodynamic output during fibrillation , hemodynamically compromising tachycardia , or asystole . forcing fields are applied to the heart to give cardiac output on an emergency basis until the arrhythmia ceases or other intervention takes place . the device is used as a stand alone external or internal device , or as a backup to an icd , atrial defibrillator , or an anti - tachycardia pacemaker . the method and apparatus maintain some cardiac output and not necessarily defibrillation .

the present invention will now be described more fully hereinafter with reference to the accompanying drawings , in which preferred embodiments of the invention are shown . this invention may , however , be embodied in many different forms and should not be construed as limited to the embodiments set forth herein . rather , applicants provide these embodiments so that this disclosure will be thorough and complete , and will convey the scope of the invention to those skilled in the art . fig1 is a block diagram illustrating a system 10 constructed in accordance with the principles of the present invention . the device circuitry is connected to the heart 40 via a series of leads ; output lead 32 , pressure sense lead 34 , and ecg sense lead 36 . the electronic circuit includes a conventional ecg amplifier 30 for amplifying cardiac signals . the amplified cardiac signals are analyzed by a conventional arrhythmia detector 20 which determines if an arrhythmia is present . the arrhythmia detector 20 may be one of several types well known to those skilled in the art and is preferably able to distinguish between different types of arrhythmias . for example ; fibrillation , tachycardia or asystole . the circuit also contains an optional pressure sensing section 28 which amplifies and conditions a signal from an optional pressure sensor from within the heart or artery . the output of the pressure sense circuit 28 is fed to a cardiac output detection circuit 18 which analyzes the data and determines an estimate of the cardiac output . data from the arrhythmia detector circuit 20 and the cardiac output detection circuit 18 is fed to the microprocessor 16 . the microprocessor 16 determines if electrical cardiac output forcing ( ecof ) is appropriate . if forcing is indicated , the microprocessor 16 prompts the output control 22 to charge a capacitor within the output circuit 26 via the capacitor charger 24 . the output control 22 directs the output circuitry 26 to deliver the pulses to the heart 40 via the output leads 32 . the microprocessor 16 may communicate with external sources via a telemetry circuit 14 within the device 10 . the power for the device 10 is supplied by an internal battery 12 . fig2 a is a diagram showing the connection of an implantable embodiment of the device 130 to the heart 40 in an epicardial patch configuration . in this thoracotomy configuration , current passes through an output lead pair 32 to electrode patches 42 which direct the current through the heart 40 . there is an optional pressure sense lead 34 which passes the signal from an optional pressure transducer 46 which lies in the heart 40 . the ecg is monitored by sense electrodes 44 and passed to the device 130 by a lead 36 . the area of the electrodes 42 is at least 0 . 5 cm 2 . the size of the electrode is greater than that of a pacing lead and no more than that of a defibrillation electrode or between approximately 0 . 5 cm 2 and 20 cm 2 each . fig2 b shows a non - thoracotomy system embodiment of the invention . in this system , the current passes from a coil electrode 52 in the heart 40 to the housing of the device 140 . an endocardial lead 50 combines the ecg sensing lead and the pulse output lead . the ecg is monitored by sense electrodes 44 in the heart 40 and passes through the endocardial lead 50 . there is an optional pressure transducer 46 in the heart 40 which passes a signal to the device 140 via optional lead 34 . fig3 shows an external embodiment of the invention . external patch electrodes 54 are placed on the chest to deliver current to the heart 40 through output lead 32 . the ecg is monitored by surface electrodes 56 and passed to the device 150 by a lead 36 . alternately , the ecg could be monitored by the external patch electrodes 54 . an optional pressure sensor 46 passes a pressure signal via an optional pressure sense lead 34 . this embodiment could be used as a substitute ( due to its small size ) for an external defibrillator and keep a patient alive until arrival at a hospital . also , the system could precede the external defibrillator by generating output in patients in asystole until blood flow and rhythm are restored . a series of forcing pulses 60 are shown in fig4 . the pulses are approximately 50 v in amplitude with a spacing of approximately 500 ms . the 50 v and the 500 ms pulse spacing are chosen as illustrative for an implantable embodiment . the forcing pulse interval is chosen to maximize cardiac output within the limits of device circuitry and the response of the heart muscle . an interval of 500 ms corresponds to a heart rate of 120 beats per minute . this will produce a greater output than a typical resting rate of 60 beats per minute . however , a rate of 240 beats per minute would produce a lower output due to mechanical limitations of the heart . thus a practical range is 60 to 200 beats per minute is appropriate . the pulses could also be timed to coincide with the natural pumping of the atria , thus improving overall cardiac output . the higher the voltage , the higher the forcing fields , and therefore a greater number of heart cells contracting producing greater cardiac output . however , the higher voltage produces greater patient discomfort and extraneous muscle twitching . implantable batteries are also limited to a certain power output and energy storage . if an output pulse is 50 v and the electrode impedance is 50 ω , the power during the pulse is p = v 2 / r = 50 v * 50 v / 50 ω = 50 w . if the pulse has a duration of 2 ms then the energy per pulse is 0 . 1 j . if two pulses are delivered every second , the charger must be capable of delivering 0 . 2 j per second which is 200 mw . this is well within the limits of an implantable battery . an implantable battery can typically deliver 5 w of power . however , 200 v pulses at 3 per second would require 4 . 8 w which is near the limit of the battery and charging circuitry . a typical implantable battery energy capacity is 10 , 000 j . delivering forcing pulses at a rate of 4 . 8 w would deplete the battery in only 35 minutes ( 10 , 000 j / 4 . 8 w = 2083 seconds ). thirty five minutes may not be enough time to transport the patient to a hospital . therefore 200 v represents the highest practical voltage for continuous operation in an implantable embodiment , although voltages of up to 350 v could be used for short periods and adjusted down when hemodynamic output is verified . a practical lower limit is about 10 v . during normal sinus rhythm , 10 v delivered through the patches would pace . however , during fibrillation the 10 v could not pace and only cells very near the electrodes would be captured . this would be insufficient for forcing cardiac output . these calculations also suggest other differences between an implantable ecof and an icd . with a battery storing 10 , 000 j and an ecof pulse having 0 . 1 j , this ecof would be capable of delivering 100 , 000 pulses . an icd can only deliver 200 - 400 shocks of about 30 j . the ecof is also very different from an implantable pacemaker which typically delivers 150 , 000 , 000 pacing pulses ( 5 years at 60 bpm ) each of about 0 . 00005 j . for an external ecof the calculations are similar , but scaled up . the typical ecof pulse would have a voltage of 100 v with a range of 25 - 500 v . with electrode impedances of 50 ω the power during the pulse is p = v 2 / r = 100 v * 100 v / 50 ω = 200 w with a range of 12 . 5 - 5 , 000 w . if the pulse has a duration of 2 - 5 ms , then the energy per pulse is 0 . 02 - 25 j . this is much less than the american heart association recommended output of 360 j for an external defibrillator . this is also different from an external transthoracic pacemaker . these devices are rated by current and typically have an output range of 30 - 140 ma . most patients are paced by pulses of 40 - 70 ma of current . an example of a modern external external thoracic pacemaker is given by freeman in application wo 93 / 01861 . assuming an electrical impedance of 50 ω and the ecof voltage range of 25 - 500 v , then the ecof current range would be 500 ma to 10 a . since electrode impedance increases with lower voltage , the 25 v ecof pulse would probably see an impedance of 100 ω thereby giving a lower current of 250 ma . fig5 is a flowchart illustrating the method of the invention , which is provided for purposes of illustration only . one skilled in the art will recognize from the discussion that alternative embodiments may be employed without departing from the principles of the invention . the flow diagram shown in fig5 represents a method of automatically treating a heart which is in fibrillation , tachycardia , or asystole and thereby pumping inefficiently or not at all . electrodes are attached 69 and diagnoses the presence of an arrhythmia 70 . a series of cardiac output forcing electric pulses 72 is automatically delivered . it should be understood that the therapy 72 may be delivered for any output compromising cardiac arrhythmia . after delivery of 10 forcing pulses ( at a rate of 60 - 200 bpm ) in the first block 72 , the status of the heart is determined 74 . if an arrhythmia is still present and there exists low pressure within the heart , more forcing pulses are delivered 78 . if the heart is pumping at a safe level , the therapy ceases and exits 76 . note that this means that the ecof successfully defibrillated the patient &# 39 ; s heart even though this is not a primary goal of the system . this could be tested in patients who were scheduled to receive an icd , in a hospital setting . those patients who are defibrillated by ecof pulse therapy could then receive the ecof instead of the larger icd . after the therapy 78 has been delivered , the pressure and ecg is again monitored 74 . if the therapy 78 is successful , it ceases and exits 76 . if the therapy 78 is unsuccessful in producing a safe level of pumping efficiency , the method proceeds to a continuous cardiac assist mode 80 . the therapy may only be stopped by an external command , for example , a telemetry signal or a magnet which is applied to the chest activating a magnetic reed switch 82 which terminates the therapy and exits 76 . to minimize patient discomfort and maximize battery life , the forcing voltage could be adjusted down when sufficient pressure signals or adequate flow measured by other means were detected , for example , the pressure sense transducer could be replaced by an oxygen detector or a doppler flow measuring device . the pulse rate could also be adjusted to maximize output . fig6 is a diagram showing the effect of a 50 v forcing pulse on the heart 40 during electrical diastole ( cells at rest ). the current is passed through the heart 40 by the electrodes 42 . approximately 60 % of cardiac cells 90 would be captured by a 50 v pulse if the cells were in diastole . the captured cells 90 mostly lie in the direct path between the electrodes 42 and near the electrodes 42 where the field strengths are highest . of course , over a time period of about 100 ms these directly captured cells then propagate an activation wavefront to stimulate the rest of the heart . this so called far - field pacing is irrelevant here as the hearts , of interest , are in fibrillation and not in diastole . fig7 is a diagram showing the effect of a 50 v forcing pulse on the heart during electrical systole ( cells already stimulated ). the current is passed through the heart 40 by the electrodes 42 . approximately 20 % of cardiac cells 100 would be captured by a 50 v pulse if the cells were in systole . the captured cells 100 are nearest each electrode 42 where the field strengths are highest . capture in systolic cells means that their activation potential is extended . this capture requires significantly higher fields ( 10 v / cm ) than those required for diastolic cell capture ( 1 v / cm ). fig8 is a diagram showing the effect of a 50 v forcing pulse on the heart during fibrillation . during fibrillation there are always cells in systole and diastole simultaneously . but , the vast majority are in systole . this diagram assumes 50 % of the cells are in diastole which applies only after several capturing pulses . the current is passed through the heart 40 by the electrodes 42 . 100 % of the cells 110 nearest the electrodes 42 would be captured due to the high field strength . as shown in fig7 even systolic cells are captured by high field strengths . 50 % of the cells 112 in the direct path between the electrodes 42 would be captured if it is assumed that 50 % of all cells are in diastole . if roughly 60 % of cardiac cells are captured by a 50 v pulse when the cells are in diastole , and 20 % are captured when in systole , and if 50 % are in systole and 50 % in diastole , 40 % would be captured during fibrillation . this calculation is shown in the following table . the last two columns give the mechanical action resulting and the contribution to forcing a cardiac output . considering the cardiac cells that are originally in diastole , ( rows a & amp ; b ) in the table below , the a row represents the diastolic cells that are not captured by the forcing pulse . if 50 % of the heart &# 39 ; s cells are in diastole and 40 % of those are not captured that is 20 % of the total cells . these cells will , however , shortly contract on their own ( from previous wavefronts or new ones ) providing a positive gain in mechanical action and therefore cardiac output . the b row corresponds to the diastolic cells that are captured . if 60 % of the diastolic cells ( 50 % of total ) contract due to the forcing field this is 30 % of the total heart cells . these cells provide the biggest gain in mechanical action and cardiac output . next considering the activity of the systolic cells ( rows c & amp ; d ), if 50 % of the heart &# 39 ; s cells are in systole and 80 % of those are not captured ( row c ), that is 40 % of the heart &# 39 ; s cells . these cells soon relax and negate a portion of the cardiac output . the systolic cells that are captured ( row d ) are 10 % of the heart &# 39 ; s cells ( 20 % of 50 %). these cells will hold their contraction and be neutral to cardiac output . the net result is a gain in contraction which forces cardiac output . the net result over a 200 ms mechanical response is given in the next table . the major contribution is in row ( b ) from the captured diastolic cells contracting . the 30 % net pumping action should be sufficient to maintain survival and consciousness , because the heart has a 4 - 5 times reserve capacity . fig9 depicts examples of waveforms designed to minimize the twitching of the chest muscles which can be very uncomfortable to the patient . in fig9 a is seen a low harmonic pulse waveform 120 which has a very gradual “ foot ” 122 and a gradual peak 124 . such a pulse has less high frequency energy components and thus is less likely to stimulate the skeletal muscle . fig9 b shows a technique of going to the opposite extreme . here , each compound forcing pulse 126 is actually composed of 50 very short spikes 128 each of which is 20 μs in width with a 20 μs spacing . the heart will tend to average out these thin pulses and “ see ” a 2 ms wide forcing pulse . the skeletal muscle , however , is not efficiently stimulated by these extremely narrow pulses . the skeletal muscle will not average out this signal either . this approach could help minimize skeletal muscle twitching and discomfort . an alternative system would be to charge the capacitor to 300 v for the first pulse to capture many cells therefore putting those cells into diastole after a delay of 100 - 200 ms . at this point the voltage could be lowered to 100 v and delivered every 100 ms . a 3 watt dc - dc converter with a 67 % efficiency could provide 100 ms interval forcing pulses assuming a 50 ω resistance and 1 ms pulse ( 0 . 2 j ). this rate is too fast for forcing cardiac output due to mechanical limitations , but is very effective for electrical capture . after sufficient capture , the rate of forcing pulses could be slowed down to 100 - 170 beats per minute for optimum cardiac output . the electrical cardiac output forcing device ( ecof ) could also be used to help patients with atrial fibrillation . as an alternative embodiment to the ventricular placement of fig2 b , the electrode coil 52 and sensing electrodes 44 could be placed in the atrium . the device could then function to force atrial output . even though atrial fibrillation is not instantly fatal like ventricular fibrillation is , clots can build up in the atria which can eventually lead to strokes . cardiac output forcing of the atria on a daily basis may limit this problem . it is also possible that after a number of forcing pulses the atria would return to a normal rhythm . there is however , no urgency as is the case with ventricular fibrillation . a second use of this invention for atrial defibrillation is shown in fig1 . as before in fig2 b , the ecof 160 is shown connected to the heart 40 via endocardial lead 50 . again forcing coil electrode 52 and sensing electrodes 44 are in the right ventricle . in addition a large atrial coil electrode 130 and atrial sensing electrodes 132 are in the right atrium . these would be used for conventional atrial defibrillation . one of the big concerns with atrial defibrillation is that in a few cases , an atrial defibrillation shock causes ventricular fibrillation . if this happens , the patient dies within minutes . with the ecof approach , for the left ventricle , one could maintain output in the patient for several hours and thus have enough time for transport to a hospital or external defibrillation . thus the ecof approach in the ventricle could provide a safety backup to atrial defibrillation . many cardiac patients have no known risk of ventricular fibrillation , but suffer regularly from ventricular tachycardia . accordingly , these people can be treated with anti - tachycardia pacing ( atp ). unfortunately , occasionally atp will cause a ventricular fibrillation . then a large defibrillation shock must be applied . thus it is not considered safe to implant a pure atp device and these patients instead receive a full size icd . the ecof approach also serves as a safety backup and thus allow the implantation of true atp devices . the system is depicted in fig2 b , although the pressure sensor 46 would typically not be needed . low energy cardioverters can also be used to treat ventricular tachycardias . these devices are also not considered safe as stand alone devices due to the fact that they may not terminate the rhythm or that they may cause fibrillation . the ecof method also could is used as a safety backup thus allowing the implantation of cardioverters without defibrillation capabilities . such a system is shown in fig2 b . it should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention . for example , while most of the discussion is in the context of an implantable device , the concepts of the invention are also applicable to external delivery systems . it is intended that the following claims define the scope of the invention and that structures and methods within the scope of these claims and their equivalents be covered thereby .

US-25155399-A

an introducer sheath assembly having a sheath tube , a hub , a valve and a valve - retaining cap on the proximal end of the hub . the cap is so secured to the hub as to have a closed , locked position and also an open position permitting access to the interior of the hub and the valve while the cap remains secured to the hub .

in the drawings , like numerals indicate like elements throughout . certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention . the terms “ distal ” and “ proximal ” refer , respectively , to directions closer to and away from the insertion tip of a catheter in an implantable catheter assembly . the terminology includes the words specifically mentioned , derivatives thereof and words of similar import . the embodiments illustrated below are not intended to be exhaustive or to limit the invention to the precise form disclosed . these embodiments are chosen and described to best explain the principle of the invention and its application and practical use and to enable others skilled in the art to best utilize the invention . introducer assembly 10 is seen in fig1 and 2 , and includes an elongate tubular sheath 12 extending to a distal end 14 , an introducer hub 16 affixed to a proximal end of the sheath 12 and having a side port 18 from which extends an extension tube 20 with luer fitting 22 , and a strain relief 24 at a distal end of the sheath hub 16 and around the tubular sheath 12 . a dilator 40 includes an elongate dilator shaft 42 extending from a distal tip 44 to a proximal end onto which is affixed a dilator hub 46 ; the dilator &# 39 ; s distal tip 44 protrudes beyond the distal end 14 of the tubular introducer sheath 12 when the dilator is fully inserted into and through the introducer assembly 10 . with reference to fig3 , hub 16 defines therethrough a passageway 26 extending to the passageway of the sheath 12 . recessed into the proximal end of the hub 16 is a valve seat portion 28 into which is placed a valve 30 that preferably includes a slit 32 ( see fig7 ) at the valve center enabling insertion therethrough of dilator shaft 42 and eventually a catheter ( not shown ). also , the proximal end of the hub includes on one side a cap capture tab 34 projecting proximally that includes pivot pins 36 projecting laterally from both sides thereof . on the opposite side of the hub proximal end from tab 34 is a catch 38 to which the cap 50 will latch in its closed position . cap 50 includes a recess 52 ( see fig5 and 7 ) along its distal surface defining a valve seat portion , and when cap 50 is attached to the hub 16 and in its closed position , retains valve 30 compressed in position within the valve seat 28 , 52 . referring to fig3 to 7 , cap 50 is seen to have a lift tab 54 depending from one side thereof that will extend alongside the hub when cap 50 is in position but project somewhat outwardly enabling manual grasping thereof to rotate cap 50 to an open position , as shown in fig7 . cap 50 will pivot as a result of cooperating tabs 56 on the opposite cap side from lift tab 54 , which tabs includes holes 58 therethrough associated with pivot pins 36 of cap capture tab 34 of hub 16 . a latch ledge 60 is defined on the inner surface of lift tab 54 that latches to catch 38 of hub 16 , to secure cap 50 in its closed position . proximal aperture 62 of cap 50 permits insertion thereinto of dilator shaft 42 and eventually the catheter ( not shown ); additionally , proximal aperture 62 may include threads or other features that cooperate with a complementary locking section of the dilator hub 46 to releasably lock the dilator to the introducer sheath assembly . with the present invention , the cap remains secured to the hub not only in the closed position but also in its open position and is thus not a loose piece , if the practitioner must obtain access to the introducer sheath passageway to remove a blockage such as a clot . it will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof . it is understood , therefore , that this invention is not limited to the particular embodiments disclosed , but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims .

US-33202508-A

a control system for the header flotation and lift hydraulics of an agricultural windrower that manages the effective and efficient removal of the header .

many of the fastening , connection , processes and other means and components utilized in this invention are widely known and used in the field of the invention described , and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art , and they will not therefore be discussed in significant detail . also , any reference herein to the terms “ left ” or “ right ” are used as a matter of mere convenience , and are determined by standing at the rear of the machine facing in its normal direction of travel . furthermore , the various components shown or described herein for any specific application of this invention can be varied or altered as anticipated by this invention and the practice of a specific application of any element may already be widely known or used in the art by persons skilled in the art and each will likewise not therefore be discussed in significant detail . fig1 shows a self - propelled windrower 10 of the type with which the instant invention may be advantageously utilized . more specifically , the figures illustrate the “ non - independent ” flotation system , discussed briefly above with reference to the &# 39 ; 729 patent . it will , however , be appreciated that the principles of the present invention are not limited in use to this particular machine , but may be used , with slight and obvious modification , on many other harvesting machines with headers and with different flotation systems , such as the “ independent ” flotation system shown in the co - pending u . s . patent application , also mentioned above . in the illustrated embodiment , the self - propelled windrower 10 comprises a tractor 12 and a header 14 , the header 14 being attached to the front end of the frame 16 or chassis of the tractor 12 . the header may be of generally any suitable construction or design , and may include not only crop - harvesting mechanisms , but also crop conditioners such as elongate rolls 15 . such attachment of the header 14 to the frame 16 is achieved through a pair of transversely spaced lower lift arms ( only the left one , 18 , being shown , the right being substantially the same ) pivoted at one end to the frame 16 and at the other end to the header 14 , as well as through a central upper link 20 . the link 20 may advantageously take the form of a single double - acting hydraulic cylinder 21 whose extension and retraction is adjusted by the operator to remotely control the angle of the cutterbar 22 on the lower front of the header 14 . referring now to fig2 , it can be seen that header 14 is pivotably supported on the two lift arms . the underside of the header 14 includes two spaced - apart axially aligned lift pins ( only the left one , 23 , being shown , the right being substantially the same ) that are engaged by lift cradles ( only the left one , 25 , being shown , the right being substantially the same ) on the outer / forward end of lift arm 18 . when the lift pins are in the cradles and the weight of header 14 is thus supported , the header may be pivoted forwardly or rearwardly ( generally longitudinally of the tractor 12 ) about the longitudinal axes of the lift pins . furthermore , some similar headers have a lock pin , not shown , which may be a spring clip or the like , to further hold the cradles and lift pins in engagement . fig2 also shows jack stand 27 , which includes an elongated leg 29 extending through a generally open - ended box - like housing 31 affixed to the rear end of header 14 . leg 29 includes a plurality of apertures 35 spaced along the length thereof and a foot 33 fixed to its lower end for selective engagement with the ground . leg 29 extends through housing 31 , which has an aperture 37 therein . by aligning an aperture through leg 29 with the aperture through housing 31 , and engaging a spring clip 41 , or the like , through the aligned apertures , the position of the foot 33 may be extended to support the header in an upright position , or retracted when the header is in use . there are several similar jack stands known in the prior art , most of which would be quite suitable for the purposes of the present invention . a single lift / flotation cylinder 24 , interconnecting the lower arm 18 and the frame 16 supports each side of the header , i . e ., each side of the header is supported by its own lift / flotation cylinder ( again , only the left one being shown in fig1 ). it is , at this point , useful to understand that within the operator &# 39 ; s cab of windrower 10 there may be located a multifunction handle (“ mfh ”), such as shown as element 54 in fig3 , to function as part of the overall implement control system . mfh 54 may be located within or closely adjacent to the console , in a convenient position to the operator &# 39 ; s right hand , and may serve as the operator &# 39 ; s input to control and manage direction and speed of travel , header height , reel speed , raise and drop rates , various inputs to controller 50 , and the like . the mfh shown is similar to that shown in more detail in u . s . pat . no . 6 , 148 , 593 , issued to heinsey et al . on nov . 21 , 2000 . the mfh of fig3 would necessarily have several switching devices , such as rocker switches 55 and 57 to either move a cursor up and down a list of menu items on a display or raise and lower the header or perform or initiate other operations , plus several selection buttons , such as switches 59 and 61 . the mfh could be replaced or supplemented by switches and buttons on the console ; however , the mfh is a very comfortable and convenient device . directing attention now to fig4 , the hydraulic control system for left cylinder 24 and right cylinder 26 can be seen to include an electro - hydraulic subsystem generally depicted as 30 . for convenience of assembly and operation , the majority of the components may be housed in a single valve body 34 with appropriately located ports and other necessary connection devices and fixtures . a fixed displacement pump 36 moves the hydraulic fluid into subsystem 30 from reservoir 40 , through the various circuits as directed by control valves , to a single accumulator 42 , to hydraulic cylinders 24 , 26 and back to reservoir 40 as appropriate . while fig4 should be readily understood by one of skill in the art , it is helpful to broadly identify the various components in more detail . a prv ( pressure reducing valve ) 38 operates as part of the hydraulic counterweight system . element 39 is a master solenoid valve with an associated relief valve 43 . a prv 44 for the lift / flotation and drop rate functions is in flow communication with the lower solenoid valve 46 , and the float solenoid valve 49 . reference number 48 identifies the raise solenoid valve . fig5 provides a more detailed depiction of the complete control system and subsystems . the hydraulic system , as shown also in fig5 , additionally depicts the electrical control and mechanical subsystems . importantly , this figure depicts the multi - channel programmable controller 50 which exchanges electrical signals from the float switch 52 , the pwm ( pulse width modulated ) solenoid 56 associated with prv 44 , the master valve 39 , and other valves to manage the lift and flotation functions as established by the operator through the appropriate switch and shown on display 64 . also depicted in fig5 is mfh 54 . the hydraulic cylinders , attached to respective ends of the header 14 , perform both the lift and flotation functions . the lifting and floating function is achieved by coupling the hydraulic pump ( s ), control manifold , and accumulator ( s ). the operator sets the desired flotation force by actuating a rocker switch located on the operator &# 39 ; s console or the mfh . one switch position allows hydraulic oil to enter the accumulator ( increasing the hydraulic pressure ), which reduces the header contact force , or flotation force , with the ground . the other switch position allows oil to exit the accumulator ( reducing the hydraulic pressure ), which increases the header contact force with the ground . once the flotation force is set , the control valves will return to this preset flotation condition whenever the float mode is selected , irrespective of subsequent header lift and lower operations . removal of the header , whether because field operations are completed , service is required , or to employ a different header , has not always been a particularly easy task for the operator . referring again to the figures , the improved process for the safe , easy , and controlled removal of the header by a single operator will be described . first , the operator will remove any pins or other locking devices that serve to keep the header engaged in the lift arm cradle , and also lower the jack stand to a position where it will support the header when it is fully lowered . second , the operator will lower the header to the ground by engaging the “ lower header ” switch ( a rocker switch either on the mfh or on the console ). third , the flotation setting is reduced to zero by energizing solenoid valve 56 via holding the decrease side of its rocker switch — which will show decreasing values to zero . when zero flotation is reached , controller 50 enters the “ header removal mode ” ( hrm ), lowering the header slowly and steadily by energizing the prv circuit ( solenoid valves 44 , 46 and 49 ) and reducing the hydraulic pressure in the lift cylinder and accumulator to zero ( open to tank ) and keeping it there . in this manner , the header is lowered to the ground with no backpressure to prevent the lift arms from going all the way to the ground . fifth , three seconds after entering the hrm ( second time period ), the controller checks to see whether the park brake 70 , in fig5 , is engaged ( via a circuit from the park brake to the controller ). if brake 70 is engaged , the prv circuit continues to maintain zero pressure for a set time period ( first time period ), for example , five minutes , to provide sufficient time for the operator to safely exit the cab to carry out the “ seventh ” step , below . the three - second interval is somewhat arbitrarily chosen , the requirement being that enough time is provided to drain the lift cylinders and the accumulator . likewise , the five minute time period could be any reasonable amount , so long as it provides sufficient time for the job to be completed . this is an added feature that discourages the operator from unnecessarily exiting the cab during the process when the vehicle could move . sixth , the operator extends the tilt cylinder 21 to a length that exhibits freedom from load , allowing the cylinder to be disconnected from the header — accomplished by energizing the cylinder via a rocker switch either on the console or mfh . seventh , the operator leaves the cab and confirms that the lift arm and lift pins are separated , and disconnects the hydraulic hoses . the operator may have to use the leverage of a bar to completely separate the lift arms and lift pins . the tractor may now be backed away from the header . the second time period limits the overall amount of time the operator has to complete the header removal process . if the second time period expires , the ecu ceases to activate the prv circuit , thus exiting the hrm . further , if the second time period expires and the operator wants to continue the removal process , the “ lower header ” side of the header raise and lower switch must be pressed twice , as explained in further detail below , to instigate an additional second time period ( five minutes , for example ). if the operator then wants to drive the tractor to another location , it is likely that he will want to raise the lift arms by pressing and holding the “ raise header ” side of the rocker switch ( mentioned above regarding the second step of the header removal process ). it should be noted that the lift arms can be raised or lowered while in the hrm by way of the aforementioned rocker switch , but if the “ lower header ” side of the switch is pressed the system does not immediately lower . instead , it prompts the operator with a warning , visual or audible , to indicate that the lift arms are being regulated with zero pressure . the operator must subsequently , within five seconds ( third time period ), press the “ lower header ” switch a second time for the lower circuits to activate . this is important in the event that the lift arms were not empty , but rather were still supporting a considerable amount of weight , such as a header . the five second interval is somewhat arbitrarily chosen , the requirement being that enough time is provided to press the switch a second time and not so excessive as to allow an unsafe condition . also , while in the hrm , an audible warning may be sounded every few seconds , 15 for example , to remind the operator of the status of the system . if the operator has navigated the tractor to a header that he wishes to engage , and the lift arms are not in a fully lowered position , pressing the “ lower header ” side of the switch and satisfying the two - push requirement will activate the hydraulic lowering circuits to maintain the hydraulic pressure in the lift cylinder and accumulator at zero ( open to tank ). the lift arms may fall of their own accord or may need an assist , depending on the amount of friction present . if the operator must climb out of the cab to help lower the lift arms , having the park brake engaged will allow the activation to continue for a set time period , five minutes for example , to provide sufficient time for the operator to safely exit the cab and help lower the lift arms . to exit the hrm when a header has been reattached , the operator must increase the flotation setting by incrementing the float switch until 100 psi is reached . then , controller 50 leaves the hrm , restores the flotation settings that were employed prior to entering the hrm , and reverts back to normal header lift and flotation operation . these settings , of course , can be changed if a different header is attached or the operating conditions are to be modified . the accumulator circuit is recharged when the header lower switch is pressed for the first time after exiting hrm . it will be understood that changes in the details , materials , steps and arrangements of parts which have been described and illustrated to explain the nature of the invention will occur to and may be made by those skilled in the art upon a reading of this disclosure within the principles and scope of the invention . for example , a touch screen visual display could be used , thus making the screen a primary input device . the foregoing description illustrates the preferred embodiment of the invention ; however , concepts , as based upon the description , may be employed in other embodiments without departing from the scope of the inventions .

US-30198905-A

a system for replacing a hip joint can include a first acetabular cup formed of a first material and having a first inner diameter and a first thickness . a second acetabular cup can be formed of a second material and having a second inner diameter and a second thickness . a first femoral hip prosthesis can include a first femoral head that is alternately accommodated by either of the first or second acetabular cups . a bearing can be adapted to be interposed between the first femoral head and one of the first or second acetabular cups . the first and second inner diameters can be the same . the first thickness can be less than the second thickness . the first material can be distinct from the second material .

the following description will be specifically directed toward a primary hip replacement procedure wherein a femoral hip prosthesis , an acetabular cup , and a bearing are implanted into the patient . it is appreciated however that the following teachings may also be applied to a surgical procedure for implanting other combinations of acetabular components . moreover , the following teachings may also be applicable to a hip revision surgical procedure wherein a surgeon may be required to remove entirely or portions of a previously implanted hip prosthesis . with initial reference to fig1 , a system or kit for use during a surgical hip replacement procedure is shown and generally identified at reference numeral 10 . the kit 10 can generally include a plurality of femoral hip prostheses collectively referred to at reference numeral 12 , a first set of acetabular cups collectively referred to at reference numeral 14 , a second set of acetabular cups collectively referred to at reference numeral 16 and a set of bearings collectively referred to at reference numeral 18 . the femoral hip prostheses 12 can include a first , second , third and fourth femoral hip prosthesis 22 a , 22 b , 22 c and 22 d , respectively . the first femoral hip prosthesis 22 a can generally include a stem 24 a , a neck 26 a and a head 28 a . the second femoral hip prosthesis 22 b can generally include a stem 24 b , a neck 26 b and a head 28 b . the third femoral hip prosthesis 22 c can include a stem 24 c , a neck 26 c and a head 28 c . the fourth femoral hip prosthesis 22 d can include a stem 24 d , a neck 26 d and a head 28 d . the heads 28 a - 28 d each have a different diameter d 1 - d 4 , respectively . in one example , as will be described further below , the diameters d 1 - d 4 can increase in size sequentially from the head 28 a to the head 28 d . the hip prostheses 12 can be modular having specific head , neck and stem configurations . the hip prosthesis 12 can also be monolithic . the first set of acetabular cups 14 can generally include a first acetabular cup 34 a , a second acetabular cup 34 b , a third acetabular cup 34 c and a fourth acetabular cup 34 d . each of the acetabular cups 34 a - 34 d is formed of a first material and has a common thickness t 1 . in one example , the first material can be cobalt - chrome molybdenum . according to the present teachings , and as will be described further below , the inner diameter and the outer diameter of the first set of acetabular cups 14 is sequentially increased from the first acetabular cup 34 a through the fourth acetabular cup 34 d . the first set of acetabular cups 14 can each include a plurality of passages 35 a - 35 d formed therethrough . the second set of acetabular cups 16 can generally include a first acetabular cup 36 a , a second acetabular cup 36 b , a third acetabular cup 36 c and a fourth acetabular cup 36 d . each of the acetabular cups 36 a - 36 d is formed of a second material and has a thickness t 2 . in one example , the second material can be titanium . according to the present teachings , and as will be described further below , the inner diameter and the outer diameter of the second set of acetabular cups 16 is sequentially increased from the first acetabular cup 36 a through the fourth acetabular cup 36 d . each of the acetabular cups of the second set of acetabular cups 16 includes a plurality of optional screw receiving passages 37 a - 37 d . any or all of the first and second sets of acetabular cups 14 and 16 can include an outer layer of porous material to enhance bony ingrowth . the first set of bearings 18 can generally include a first bearing 38 a , a second bearing 38 b , a third bearing 38 c and a fourth bearing 38 d . each of the bearings 38 a - 38 d has a common thickness t 3 . the bearings 18 can have any suitable configuration , such as constrained bearings , high - wall bearings or other bearing configurations . according to the teachings of the present disclosure , in the present example , each component in the kit 10 is compatible with other components of the kit 10 having a similar suffix . in other words , in the present example , the femoral hip prosthesis 22 a can cooperate with the bearing 38 a and either one of the acetabular cups 34 a or 36 a . likewise , the femoral hip prosthesis 22 b can be used with the bearing 38 b and either of the acetabular cups 34 b or 36 b . the femoral hip prosthesis 22 c can be used with the bearing 38 c and either of the acetabular cups 34 c or 36 c . the femoral hip prosthesis 22 d can be used with the bearing 38 d and either of the acetabular cups 34 d or 36 d . exemplary dimensions of the components of the kit 10 will now be described for exemplary purposes . it is appreciated however that the dimensions may be changed without departing from the scope of the present disclosure . as used herein the phrase “ the same ” is used to denote an identical or substantially identical dimension within a tolerance . in one example , the dimensions can be the same within a tolerance of about 0 . 25 mm . all of the acetabular cups 34 a - 34 d and 36 a - 36 d have a hemispherical shape and include an inner bearing engaging surface and an outer bone engaging surface 40 and 42 , respectively ( only identified on acetabular cup 34 a for clarity ). various diameters can be provided for the acetabular cups 34 a - 36 d as described below . in general , an inner diameter d 5 of the acetabular cup 34 a is the same or substantially the same as an inner diameter d 6 of the acetabular cup 36 a . likewise , an inner diameter d 7 of the acetabular cup 34 b is the same or substantially the same as an inner diameter d 8 of the acetabular cup 36 b . the inner diameter d 9 of the acetabular cup 34 c is the same or substantially the same as the inner diameter d 10 of the acetabular cup 36 c . the inner diameter d 11 of the acetabular cup 36 d is the same or substantially the same as the inner diameter d 12 of the acetabular cup 36 d . in one example , the inner diameters d 5 and d 6 can be 41 mm , the inner diameters d 7 and d 8 can be 45 mm , the inner diameters d 9 and d 10 can be 49 mm and the diameters d 11 and d 12 can be 53 mm . in general , the outer diameters d 13 - d 20 sequentially increase by 2 mm . thus , the acetabular cup 34 a can have an outer diameter d 13 of 46 mm . the acetabular cup 36 a can have an outer diameter d 14 that is 48 mm . the acetabular cup 34 b can have an outer diameter d 15 that is 50 mm . the acetabular cup 36 b can have an outer diameter d 16 that is 52 mm . the acetabular cup 34 c can have an outer diameter d 17 that is 54 mm . the acetabular cup 36 c can have an outer diameter d 18 that is 56 mm . the acetabular cup 34 d can have an outer diameter d 19 that is 58 mm . the acetabular cup 36 d can have an outer diameter d 20 that is 60 mm . in one example , the thickness t 1 is 2 . 5 mm and the thickness t 2 is 3 . 5 mm . in the present example , the bearing 38 a has an inner diameter d 21 of 32 mm and an outer diameter d 22 of 41 mm . the bearing 38 b has an inner diameter d 23 of 36 mm and an outer diameter d 24 of 45 mm . the bearing 38 c has an inner diameter d 25 of 40 mm and an outer diameter d 26 of 49 mm . the bearing 38 d has an inner diameter d 27 of 44 mm and an outer diameter d 28 of 53 mm . in this example , the thickness t 3 of each of the bearings 38 a - 38 d can be 4 . 5 mm . the diameter of the head 28 a of the femoral hip prosthesis 22 a can be 32 mm . the diameter of the head 28 b of the femoral hip prosthesis 22 b can be 36 mm . the diameter d 3 of the head 28 c of the femoral hip prosthesis 22 c can be 40 mm . the diameter d 4 of the head 28 d of the femoral hip prosthesis 22 d can be 44 mm . again it will be appreciated that the dimensions set forth herein are merely exemplary . furthermore , the dimensions may be approximate . again , inner diameters of various acetabular cups 14 , 16 that are described as being the same or substantially the same are so within specific tolerances . with additional reference now to fig2 - 5 , an exemplary method for using the kit 10 to replace a hip joint according to one example of the present teachings will now be described . initially , an acetabulum 50 can be reamed , such as with a reamer 52 . the exemplary reamer 52 can comprise a reamer drive shaft 54 that is rotatably supported within a cannulated shaft 56 . a cutting member 60 can be selectively coupled at a distal end 62 of the reamer drive shaft 54 . a mating structure 64 can be provided at a proximal end of the reamer drive shaft 54 . a driver ( not shown ) may be operably coupled with the mating structure 64 to impart rotational force through the reamer drive shaft 54 to the cutting member 60 . the acetabulum 50 may be generally hemispherically reamed until concentric removal of all acetabular cartilage and / or bone cement and portions of host bone if necessary ( e . g ., such as during a revision procedure ) is achieved . once the acetabulum 50 has been appropriately reamed , trial gauges ( not shown ), which are well known in the art , may be used to determine the size of the reamed acetabulum 50 . a corresponding outer diameter of a suitable acetabular cup ( e . g ., a corresponding acetabular cup from the first and second sets of acetabular cups 14 and 16 ) is then known . as illustrated in fig3 , the acetabulum 50 is shown having a reamed acetabular socket 68 . again , it can be desirable to leave as much host bone from the acetabulum 50 in place . as explained above , the first set of acetabular cups 14 are all formed by cobalt - chrome molybdenum and have a thickness of 2 . 5 mm . the second set of acetabular cups 16 are all formed of titanium and have a thickness of 3 . 5 mm . as is known , the stiffness of cobalt - chrome molybdenum per unit thickness is higher than titanium . moreover , titanium has a higher flexibility per unit thickness than cobalt - chrome molybdenum . because each acetabular cup 34 a - 34 d of the first set of acetabular cups 14 is thinner than each acetabular cup 36 a - 36 d of the second set of acetabular cups 16 ( 2 . 5 mm vs . 3 . 5 mm ), the stiffness of an acetabular cup 34 a - 34 d of the first set of acetabular cups 14 relative to a corresponding acetabular cup 36 a - 36 d of the second set of acetabular cups 16 is the same or substantially the same . in this way , a surgeon 70 ( fig4 ) is able to achieve a desired stiffness utilizing any of the acetabular cups from the first or second sets of acetabular cups 14 and 16 to attain a desired press - fit relationship into the reamed acetabular socket 68 of patient 72 . with continued reference now to fig4 , by initially starting with cobalt - chrome molybdenum , a thinner 2 . 5 mm thickness acetabular cup ( such as acetabular cup 34 a ) can be used to accommodate a first femoral head size ( i . e ., d 1 of femoral head 28 a ). when the surgeon 70 may require the next larger size outer diameter acetabular cup ( such as the acetabular cup 36 a ), the same femoral head 28 a can be used since the inner diameter ( i . e ., d 5 vs . d 6 ) stays the same and the material of the acetabular cup changes to titanium having a thickness of 3 . 5 mm ( and consequently the acetabular cup outer diameter increases by 2 mm ). if the surgeon 70 determines that the next larger size femoral head ( i . e ., femoral head 28 b ) should be used , the surgeon 70 can select the cobalt - chrome molybdenum acetabular cup 34 b having the thickness of 2 . 5 mm . if it is determined that the next size larger outer diameter acetabular cup is required , the surgeon 70 can select the titanium acetabular cup 36 b having a thickness of 3 . 5 mm . again , it is appreciated that the femoral hip prosthesis 22 b having the head 28 b can be used for either of the acetabular cups 34 b or 36 b because the inner diameters d 7 vs . d 8 are the same or substantially the same . as can be appreciated , the surgeon 70 can make similar decisions as to whether other acetabular cups , such as 34 c - 36 d or others may be particularly suited for a given patient 72 . nevertheless , the kit 10 can be used by the surgeon 70 to minimize host bone loss without having to compromise head size of the femoral hip prosthesis while at the same time providing the surgeon 70 with the desired acetabular cup flexibility during implantation . furthermore , with the kit 10 , a larger diameter head can be used 50 % of the time as a cobalt - chrome molybdenum cup can be used having the same outer diameter as a comparable titanium cup while offering a larger inner diameter that accommodates the larger diameter head . as used herein , the term “ kit ” or “ system ” is used to denote a collection of readily available components ( i . e ., acetabular cups , bearings and / or femoral hip prostheses ) available for a surgeons easy selection . the collection of readily available components can be grouped or arranged in any manner that provides the surgeon with comprehensive access and ease of identification . in this way , each of the components may be prepackaged individually in sterile containers while still being offered as a collective kit or set of components . turning now to fig5 , an acetabular cup 36 a is shown implanted into the reamed acetabular socket 68 . the cup 36 a can be implanted by any suitable method . according to one such method , an impacting instrument ( not shown ) may be used to properly position the acetabular cup 36 a . in one example , the impacting instrument may be threadably secured to an apical hole ( not specifically shown ) of the acetabular cup 36 a . once the orientation of the acetabular cup 36 a is acceptable , the inserting instrument may be solidly impacted to fully seat ( or press - fit ) the acetabular cup 36 a into the acetabular socket 68 , such that firm rim fixation is achieved . once the acetabular cup 36 a has been solidly impacted , the inserting instrument may be carefully removed from the acetabular cup 36 a . a plurality of bone screw holes ( not specifically shown ) may be bored into the acetabulum 50 while aligning with existing holes 37 a already formed in the acetabular cup 36 a . once the bone screw holes have been formed in the acetabulum 50 , as is also known in the art , a depth gauge ( not shown ) may be used to determine the length of the fixation screws . with the length of the screws determined , a fixation screw or multiple fixation screws 76 may be advanced through the respective holes 37 a in the acetabular cup 36 a and driven into the screw holes in the acetabulum 50 . in other examples , the acetabular cup 36 a additionally or alternatively may be cemented into the acetabulum 50 . the foregoing description of the embodiments has been provided for purposes of illustration and description . it is not intended to be exhaustive or to limit the disclosure . individual elements or features of a particular embodiment are generally not limited to that particular embodiment , but , where applicable , are interchangeable and can be used in a selected embodiment , even if not specifically shown or described . the same may also be varied in many ways . such variations are not to be regarded as a departure from the disclosure , and all such modifications are intended to be included within the scope of the disclosure .

US-43622509-A

according to the present invention , a convertible footwear apparatus can be worn as a shoe or converted to a boot by attaching or removing an upper section from the shoe . the apparatus is configured to allow someone wearing the shoe component to attach or remove the upper section with a single continuous operation and without having to remove the shoe component from the wearer &# 39 ; s foot . in one embodiment of the invention , the apparatus comprises a zipper . in another embodiment of the invention , the shoe component includes a heel .

the present invention now will be described more fully hereinafter with reference to the accompanying figures , in which some , but not all embodiments of the inventions are shown . indeed , these inventions may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein ; rather , these embodiments are provided so that this disclosure will satisfy applicable legal requirements . like numbers refer to like elements throughout . as illustrated in fig1 , a preferred embodiment of the invention may include an upper section 10 and a shoe 11 . upper section 10 may be comprised of leather , plastic , suede , or any other material known to a person of ordinary skill in the art . shoe 11 may be comprised of the same material as upper section 10 or a different leather , plastic , suede , or any other material known to a person of ordinary skill in the art . upper section 10 may be removably coupled to shoe 11 by a coupling mechanism 21 , such that upper section 10 can be attached and then detached from shoe 11 . coupling mechanism 21 may be comprised of a zipper , magnets , velcro , buttons , or any other coupling mechanism known to a person of ordinary skill in the art . additionally , one side of the coupling mechanism may be fixed to upper section 10 while the other side of the coupling mechanism may be fixed to the shoe 11 . for example , in one preferred embodiment , the coupling mechanism 21 comprises a zipper . in a preferred embodiment , one half of the zipper may be fixed to upper section 10 by using epoxy , stitching , or any other numerous methods known to a person of ordinary skill in the art . the other half of the zipper may be fixed to shoe 11 by using epoxy , stitching , or any other numerous methods known to a person of ordinary skill in the art . the upper section 10 may be split or separated such that it can be wrapped around or removed from a person &# 39 ; s leg without the person &# 39 ; s leg needing to thread through the upper section like a tube . therefore , a person wearing shoe 11 may convert from a shoe to a boot , and vice versa , without having to remove the shoe 11 from the person &# 39 ; s foot or having to thread the shoe 11 through the upper section 10 . the upper section 10 may be removably fixed around a person &# 39 ; s leg using a coupling mechanism 20 . coupling mechanism 20 may be comprised of a zipper , magnets , velcro , buttons , or any other coupling mechanism known to a person of ordinary skill in the art . additionally , one side of the coupling mechanism may be fixed to one side of upper section 10 while the other side of the coupling mechanism may be fixed to the other side of upper section 10 . for example , in one preferred embodiment , the coupling mechanism 20 comprises a zipper . in a preferred embodiment , one half of the zipper may be fixed to one side of upper section 10 by using epoxy , stitching , or any other numerous methods known to a person of ordinary skill in the art . the other half of the zipper may be fixed to the other side of upper section 10 by using epoxy , stitching , or any other numerous methods known to a person of ordinary skill in the art . coupling mechanism 20 may be continuous with coupling mechanism 21 such that a single , continuous operation may attach ( or remove ) one side of the upper section with another side of the upper section while also attaching ( or removing ) the upper section from the shoe . for example , in a preferred embodiment , one half of coupling mechanism 20 and one half of coupling mechanism 21 are comprised of portions of the same single continuous structure . in other words , an upper portion of a single continuous structure constitutes one half of coupling mechanism 20 and a lower portion of that single continuous structure constitutes one half of coupling mechanism 21 . in this preferred embodiment , the other half of coupling mechanism 20 is separate from the other half of coupling mechanism 21 . that is , the structure that constitutes the other half coupling mechanism 20 does not also constitute the other half of coupling mechanism 21 . in a preferred embodiment , coupling mechanism 20 and coupling mechanism 21 both comprise zippers fixed to one another in such a way as to allow a single , continuous zipper operation to attach or remove one side of upper section 10 with another side of upper section 10 while also attaching or removing , respectively , upper section 10 from the shoe 11 . some preferred embodiments are explained in more detail with reference to fig2 a , 2b and fig3 a , 3b . in another preferred embodiment , the coupling mechanisms 20 and 21 are obscured from view . this may be accomplished by using a very small coupling mechanism , such as a very small zipper , magnets , velcro , buttons , or any other small coupling mechanism known to a person of ordinary skill in the art . this may also be accomplished by extending the material of upper section 10 and / or shoe 11 such that the material covers the coupling mechanisms 20 and 21 , and thereby obscures the coupling mechanisms 20 and 21 from view . in yet another preferred embodiment , shoe 11 may be flat . in yet another preferred embodiment , shoe 11 may additionally comprise a heel . as illustrated in fig2 a and 2b , a preferred embodiment of the invention includes coupling mechanisms 20 and 21 comprising zippers . fig2 a shows an exemplary embodiment of the invention illustrating a zipper , fully zipped up , configured to attach and detach the upper section of a boot . the upper part of zipper half 120 a may be fixed to one side of upper section 10 while zipper half 120 b may be fixed to the other side of upper section 10 . zipper half 120 b ends at the bottom of upper section 10 . therefore , in a preferred embodiment , coupling mechanism 20 comprises the upper part of zipper half 120 a and zipper half 120 b . the lower part of zipper half 120 a may continue past zipper half 120 b , such that it may connect with zipper half 121 b . zipper half 121 b may be fixed to shoe 11 , such that lower part of zipper half 120 a and zipper half 121 b are configured to removably attach upper section 10 to shoe 11 . therefore , in a preferred embodiment , coupling mechanism 21 comprises lower part of zipper half 120 a and zipper half 121 b . zipper block 100 travels the entire length of zipper half 120 a , in order to connect ( or disconnect ) the upper part of zipper half 120 a with zipper half 120 b , and in order to connect ( or disconnect ) the lower part of zipper half 120 a with zipper half 121 b . zipper block 100 may connect ( or disconnect ) the zipper halves by using conventional zipper teeth interlocking understood by a person of ordinary skill , or by any other means understood by a personal of ordinary skill . fig2 b shows an exemplary embodiment of the invention illustrating a zipper , partially unzipped , configured to attach and detach the upper section of a boot . as shown in the figure , zipper block 100 may travel down zipper half 120 a to disconnect both zipper half 120 b and zipper half 121 b in a single , continuous zipper operation . therefore , one side of upper section 10 may be decoupled from the other side of upper section 10 , and upper section 10 may be removed from shoe 11 with a single , continuous zipper operation . conversely , when the zipper block travels in the opposite direction , upper section 10 may be attached to shoe 11 , and one side of upper section 10 may be coupled to the other side of upper section 10 with a single , continuous zipper operation . as illustrated in fig3 a and 3b , a preferred embodiment of the invention includes coupling mechanisms 20 and 21 comprising zippers . fig3 a and 3b comprise all of the components of fig2 a and 2b , but further comprise two end stops and a bridge stop . end stop 220 b may replace the end of zipper half 120 b with a rectangular section , comprising plastic , metal , or any other suitable material known to a person of ordinary skill . it is known to a person of ordinary skill how to replace the end of a zipper half with an end stop , as it is typical to use such end stops at the ends of zipper halves . however , in accordance with a preferred embodiment of the invention , and unlike typical zippers , end stop 220 b at the end of zipper half 120 b may be adjacent to end stop 221 at the end of zipper half 121 b . end stop 221 may replace the end of zipper half 121 b with a rectangular section , comprising plastic , metal , or any other suitable material known to a person of ordinary skill . additionally , each of these end stops may be adjacent to bridge stop 220 a . bridge stop 220 a may replace a section of zipper half 120 a with a rectangular section , comprising plastic , metal , or any other suitable material known to a person of ordinary skill . bridge stop 220 a may be the size of end stops 220 b and 221 combined and may function to facilitate the single , continuous motion of zipper block 100 . this is shown in fig3 b , which displays an exemplary embodiment of the invention illustrating a zipper , partially unzipped , configured to attach and detach the upper section of a boot . in another preferred embodiment , not shown , bridge stop 200 a may be used to fuse together two shorter zipper halves to comprise zipper half 120 a . this may ease manufacturing , as it may be more efficient to manufacture two separate zipper halves joined at a bridge stop than to manufacture one monolithic zipper half with a bridge stop in the middle . many modifications and other embodiments of the inventions set forth herein will come to mind to one skilled in the art to which these inventions pertain having the benefit of the teachings presented in the foregoing descriptions and the associated figures . therefore , it is to be understood that the inventions are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims . although specific terms are employed herein , they are used in a generic and descriptive sense only and not for purposes of limitation .

US-201514972175-A

an inhaler includes a main body having a canister housing , a medicament canister retained in a central outlet port of the canister housing , and a dose counter having an actuation member for operation by movement of the medicament canister . the canister housing has an inner wall , and a first inner wall canister support formation extending inwardly from a main surface of the inner wall . the canister housing has a longitudinal axis x which passes through the center of the central outlet port . the first inner wall canister support formation , the actuation member , and the central outlet port lie in a common plane coincident with the longitudinal axis x such that the first inner wall canister support formation protects against unwanted actuation of the dose counter by reducing rocking of the medicament canister relative to the main body of the inhaler .

fig1 shows a main body 10 of a manually operated metered dose inhaler 12 in accordance with an embodiment related to the present invention and having a mouthpiece cap 14 securable over a mouthpiece 16 of the main body . the main body has a canister chamber 18 into which a canister 20 ( fig7 a ) is slideable . the canister 20 has a generally cylindrical main side wall 24 , joined by a tapered section 26 to a head portion 28 having a substantially flat lower face 30 which has an outer annular drive surface 32 arranged to engage upon and drive an actuation pin 34 of a dose counter 36 as will be described . extending centrally and axially from the lower face 30 is a valve stem 38 which is arranged to sealingly engage in a valve stem block 40 of the main body 10 of the inhaler 12 . the valve stem block 40 has a passageway 42 leading to a nozzle 44 for directing the contents of the canister 20 , namely active drug and propellant , towards an air outlet 46 of the inhaler main body 12 . it will be appreciated that due to gaps 48 between the canister 20 and an inner wall 50 of the main body 10 of the inhaler 12 an open top 52 of the main body 10 forms an air inlet into the inhaler 12 communicating via air passageway 54 with the air outlet 46 , such that canister contents exiting nozzle 44 mix with air being sucked by the user through the air passageway 54 in order to pass together through the air outlet and into the mouth of the user ( not shown ). the dose counter 36 will now be described . the dose counter 36 includes an actuation pin 34 biased upwardly from underneath by a return spring 56 once installed in the main body 10 . as best shown in fig4 a , 6h and 8a , the pin 34 has side surfaces 58 , 60 arranged to slide between corresponding guide surfaces 62 , 64 located in a dose counter chamber 66 of the main body 10 , as well as an end stop surface 68 arranged to engage a corresponding end stop 70 formed in the dose counter chamber 66 to limit upward movement of the pin 34 . the pin 34 has a top part 72 which is circularly cylindrical and extends through an aperture 74 formed through a separator wall 76 which separates the canister chamber 18 from the dose counter chamber 66 . the top part 72 of the pin 34 has a flat top surface 78 which is arranged to engage the outer annular drive surface 32 of the canister 20 . the actuation pin 34 is integrally formed with a drive or actuator pawl 80 . the actuator pawl 80 has a generally inverted u - shape configuration , having two mutually spaced and parallel arms 82 , 84 extending from a base portion of the actuation pin 34 , each holding at respective distal ends 88 thereof opposite ends of a pawl tooth member 90 which extends in a direction substantially perpendicular to the arms 82 , 84 , so as to provide what may be considered a “ saddle ” drive for pulling on each of the 11 drive teeth 92 of a ratchet wheel 94 of an incremental drive system 96 or ratchet mechanism 96 of the dose counter 36 . as shown for example in fig1 b , the pawl tooth member 90 has a sharp lower longitudinal side edge 98 arranged to engage the drive teeth 92 , the edge - to - surface contact provided by this engagement providing very accurate positioning of the actuator pawl 80 and resultant rotational positioning of the ratchet wheel 94 . the dose counter 36 also has a chassis preassembly 100 which , as shown in fig4 a and 6a , includes a chassis 102 having a first shaft 104 receiving the ratchet wheel 94 which is secured to a tape reel shaft 106 , and a second shaft ( or split pin ) 108 which is parallel to and spaced from the first shaft 104 and which slidably and rotationally receives a tape stock bobbin 110 . as shown in fig6 b , when the inhaler has not been used at all , the majority of a tape 112 is wound on the tape stock bobbin 110 and the tape 112 has a series of regularly spaced numbers 114 displayed therealong to indicate a number of remaining doses in the canister 20 . as the inhaler is repeatedly used , the ratchet wheel 94 is rotated by the actuator pawl 80 due to operation of the actuation pin 34 by the canister 20 and the tape 112 is incrementally and gradually wound on to the tape reel shaft 106 from the second shaft 108 . the tape 112 passes around a tape guide 116 of the chassis 102 enabling the numbers 114 to be displayed via a window 118 in a dose counter chamber cover 120 having a dose marker 132 formed or otherwise located thereon . as shown in fig6 a and 6d , the second shaft 108 is forked with two forks 124 , 126 . the forks 124 , 126 are biased away from one another . the forks have located thereon at diametrically opposed positions on the second shaft 108 friction or control elements 128 , 130 , one on each fork . each control element extends longitudinally along its respective fork 124 , 126 and has a longitudinally extending friction surface 132 , 134 which extends substantially parallel to a longitudinal axis of the second shaft and is adapted to engage inside a substantially cylindrical bore 136 inside the tape stock bobbin 110 . this control arrangement provided between the bore 136 and the control elements 128 , 130 provides good rotational control for the tape stock bobbin 110 such that it does not unwind undesirably such as when the inhaler is dropped . the tape force required to unwind the tape stock bobbin 110 and overcome this friction force is approximately 0 . 1 n . as can be seen in fig6 d , as well as fig6 g and 10a to 10f , the chassis 102 is provided with an anti - back drive tooth 138 or count pawl 138 which is resiliently and substantially fixedly mounted thereto . as will be described below and as can be seen in fig1 a to 10f , when the actuation pin 34 is depressed fully so as to fire the metered valve ( not shown ) inside the canister 20 , the actuator pawl 80 pulls down on one of the teeth 92 of the ratchet wheel 94 and rotates the wheel 94 anticlockwise as shown in fig6 d so as to jump one tooth 92 past the count pawl 138 , thereby winding the tape 112 a distance incrementally relative to the dose marker 122 on the dose counter chamber 120 so as to indicate that one dose has been used . with reference to fig1 b , the teeth of the ratchet wheel 94 have tips 143 which are radiused with a 0 . 1 mm radius between the flat surfaces 140 , 142 . the ratchet wheel 94 has a central axis 145 which is 0 . 11 mm above datum plane 220 ( fig9 ). a top / nose surface 147 of the anti - back drive tooth 138 is located 0 . 36 mm above the datum plane 220 . the distance vertically ( i . e . transverse to datum plane 220 — fig9 ) between the top nose surface 147 of the anti - back drive tooth is 0 . 25 mm from the central axis 145 of the wheel 94 . bump surface 144 has a lateral extent of 0 . 20 mm , with a vertical length of a flat 145 ′ thereof being 1 mm , the width of the bump surface being 1 . 22 mm ( in the direction of the axis 145 ), the top 149 of the bump surface 144 being 3 . 02 mm vertically below the axis 145 , and the flat 145 ′ being spaced a distance sideways ( i . e . parallel to the datum plane 220 ) 2 . 48 mm from the axis 145 . the top surface 78 of the pin 34 ( fig6 h ) is 11 . 20 mm above the datum plane 220 ( fig9 ) when the actuator pawl 80 and pin 34 are in the start configuration . the length of the valve stem 22 is 11 . 39 mm and the drive surface 32 of the canister 20 is 11 . 39 mm above the datum plane 220 when the canister is at rest waiting to be actuated , such that there is a clearance of 0 . 19 mm between the canister 20 and the pin 34 in this configuration . fig1 a and 10b show the actuator pawl 80 and ratchet wheel 94 and count pawl 138 in a start position in which the flat top 78 of the pin 34 has not yet been engaged by the outer annular drive surface 32 of the canister 20 or at least has not been pushed down during a canister depression . in this “ start ” position , the count pawl 138 engages on a non - return back surface 140 of one of the teeth 92 of the ratchet wheel 94 . the lower side edge 98 of the actuator pawl is a distance “ d ” ( fig9 ) 1 . 33 mm above datum plane 220 which passes through bottom surface or shoulder 41 of valve stem block 40 , the datum plane 220 being perpendicular to a main axis “ x ” of the main body 10 of the inhaler 12 which is coaxial with the centre of the valve stem block bore 43 and parallel to a direction of sliding of the canister 20 in the main body 10 of the inhaler 12 when the canister is fired . as shown in fig1 b , an advantageous feature of the construction is that the pawl tooth / actuator 90 acts as a supplementary anti - back drive member when the inhaler 12 is not being used for inhalation . in particular , if the inhaler 12 is accidentally dropped , resulting in a jolt to the dose counter 36 then , if the wheel 94 would try to rotate clockwise ( backwards ) as shown in fig1 b , the back surface 140 of a tooth will engage and be blocked by the tooth member 90 of the pawl 80 . therefore , even if the anti - back drive tooth 138 is temporarily bent or overcome by such a jolt , undesirable backwards rotation of the wheel 94 is prevented and , upon the next canister firing sequence , the pawl 90 will force the wheel 94 to catch up to its correct position so that the dose counter 36 continues to provide correct dosage indication . fig1 c shows a configuration in which the actuator pawl 80 has been depressed with the pin 34 by the canister 20 to a position in which the side edge 98 of the pawl tooth member 90 is just engaged with one of the teeth 92 and will therefore upon any further depression of the pin 34 begin to rotate the wheel 94 . this is referred to as a “ reset ” position or configuration . in this configuration , the lower side edge 98 of the actuator 80 is 0 . 64 mm above the datum plane 220 . fig1 d shows a configuration in which the actuator pawl 80 has been moved to a position lower than that shown in fig1 c and in which the metered dose valve ( not shown ) inside the canister has at this very position fired in order to eject active drug and propellant through the nozzle 44 . it will be noted that in this configuration the count pawl 138 is very slightly spaced from the back surface 140 of the same tooth 92 that it was engaging in the configuration of fig1 d . the configuration shown in fig1 d is known as a “ fire ” configuration . in this configuration the lower side edge 98 of the actuator 80 is 0 . 47 mm below the datum plane 220 . fig1 e shows a further step in the sequence , called a “ count ” position in which the actuator pawl 80 has rotated the ratchet wheel 94 by the distance circumferentially angularly between two of the teeth 92 , such that the count pawl 138 has just finished riding along a forward surface 142 of one of the teeth 92 and has resiliently jumped over the tooth into engagement with the back surface 140 of the next tooth . accordingly , in this “ count ” configuration , a sufficiently long stroke movement of the pin 34 has occurred that the tape 112 of the dose counter 36 will just have counted down one dose . in this configuration , the lower side edge 98 of the actuator is 0 . 95 mm below the datum plane 220 . accordingly , in this position , the actuator 80 generally , including edge 98 , is 0 . 48 mm lower than in the fire configuration . it has been found that , although the count configuration happens further on than the fire configuration , counting is highly reliable , with less than 50 failed counts per million . this is at least partially due to momentum effects and to the canister releasing some back pressure on the user in some embodiments as its internal metering valve fires . in the configuration of fig1 f , the pawl 80 has been further depressed with the pin 34 by the canister 20 to a position in which it is just disengaging from one of the teeth 92 and the actuator pawl 80 is assisted in this disengagement by engagement of one of the arms 84 with a bump surface 144 on the chassis 102 ( see fig6 g ) and it will be seen at this point of disengagement , which is called an “ end ” configuration , the count pawl 138 is positioned exactly halfway or substantially halfway between two of the drive teeth 92 . this advantageously means therefore that there is a minimum chance of any double counting or non - counting , which would be undesirable . in the end configuration , the side edge 98 of the actuator is 1 . 65 mm below the datum plane 220 . it will be appreciated that any further depression of the actuator pawl 80 and pin 34 past the “ end ” configuration shown in fig1 f will have no effect on the position of the tape 112 displayed by the dose counter 36 since the actuator pawl 80 is disengaged from the ratchet wheel 94 when it is below the position shown in fig1 f . as shown in fig7 c and 7d , the inner wall 50 of the main body 10 is provided with a two - step support rail 144 which extends longitudinally along inside the main body and is located directly adjacent the aperture 74 . as shown in fig7 b a diametrically opposed two - step support rail 146 is also provided and this diametrically opposed in the sense that a vertical plane ( not shown ) can pass substantially directly through the first rail 144 , the aperture 74 , a central aperture 148 of the valve stem block 40 ( in which canister stem 25 is located ) and the second two - step support rail 146 . as shown in fig7 a and schematically in fig7 b , the rails 144 , 146 provide a maximum clearance between the canister 20 and the rails 144 , 146 in a radial direction of almost exactly 0 . 3 mm , about 0 . 25 to 0 . 35 mm being a typical range . this clearance in this plane means that the canister 20 can only rock backwards and forwards in this plane towards away from the actuation pin 34 . a relatively small distance and this therefore prevents the canister wobbling and changing the height of the actuation pin 34 a as to undesirably alter the accuracy of the dose counter 36 . this is therefore highly advantageous . the inner wall 50 of the main body 10 is provided with two further two - step rails 150 as well as two pairs 152 , 154 of rails extending different constant radial amounts inwardly from the inner wall 50 , so as to generally achieve a maximum clearance of almost exactly 0 . 3 mm around the canister 20 for all of the rails 144 , 146 , 150 , 152 , 154 spaced around the periphery of the inner wall 50 , in order to prevent undue rocking while still allowing canister motion freely inside the inhaler 12 . it will be clear from fig7 c for example that the two - step rails have a first portion near an outlet end 156 of the canister chamber 18 , the first portion having a substantially constant radial or inwardly - extending width , a first step 160 leading to a second portion 162 of the rail , the second portion 102 having a lesser radial or inwardly extending extent than the first portion 156 , and finally a second step 164 at which the rail merges into the main inner wall 50 main surface . a method of assembling the inhaler 12 will now be described . with reference to fig8 a , the main body 10 of the inhaler 12 is formed by two or more plastics mouldings which have been joined together to the configuration shown . as shown in fig8 b , the actuator pawl 80 and pin 34 are translated forward into position into a pin receiving area 166 in the dose counter chamber 66 and the pin 34 and actuator 80 may then be raised until the pin 34 emerges through the aperture 74 . next , the return spring 56 may be inserted below the pin 34 and a generally cylindrical annular lower end 168 of the spring 56 may be moved by a tweezer or tweezer - like assembly tool ( not shown ) into engagement with a shelf 170 of a spring retainer 172 in the dose counter chamber 66 . the spring retainer 172 is u - shaped and the shelf 170 is u - shaped and has a recess 174 formed below it . as shown in fig4 b , 4c and 12 shelf 170 includes three chamfer surfaces 176 , 178 , 180 arranged to assist in moving the lower end of the spring 168 into position onto the shelf using the assembly tool ( not shown ). once the lower end of the spring 168 is in place , the assembly tool ( not shown ) can easily be removed at least partly via the recess 174 below the lower end 168 of the spring 56 . the tape 112 is attached at one end ( not shown ) to the tape stock bobbin 110 and is wound onto the bobbin by a motor 200 ( fig1 ) having a hexagonal output shaft 202 which engages in a hexagonal socket 204 ( fig6 b ) of the bobbin . during winding , the tape is monitored by a sensor 206 , which may be in the form of a camera or laser scanner , which feeds data to a computer controller 205 for the motor 200 . the controller 205 recognises three positioning markers 210 in the form of lines across the tape 112 and stops the motor 202 when the tape 112 is nearly fully wound onto the bobbin 110 , such that the distal end 212 of the tape 112 can be secured , e . g . by adhesive , to the tape reel shaft 106 . the controller 205 also recognises a pixelated tape size marker 214 observed by the sensor 206 and logs in a stocking system data store 217 details of the tape 112 such as the number of numbers 114 on the tape , such as one hundred and twenty or two hundred numbers 114 . next , the tape reel shaft is wound until an appropriate position of the lines 210 at which a priming dot 216 will , once the bobbin 110 and reel shaft 106 are slid onto the second shaft 108 and second shaft 104 , be in a position to be located in the window 118 when the inhaler 12 is fully assembled . in the embodiments , the bobbin 110 and reel shaft 106 may be slid onto the shafts 108 , 104 before the tape 112 is secured to the reel shaft 106 and the reel shaft may then be wound to position the priming dot 216 . next , the assembled dose counter components of the chassis preassembly 100 shown in fig6 b may as shown in fig8 c be inserted into the dose counter chamber 66 , with pins 182 , 184 , 186 formed on the main body 10 in the dose counter chamber 66 passing through apertures or slots 188 , 190 , 192 formed on the chassis 102 , such that the pins 182 , 184 , 186 extend through ( or at least into ) the apertures or slots 188 , 190 , 192 . with the chassis 102 being relatively firmly pushed towards the main body 10 , the pins 182 , 184 , 186 are then heat staked and the chassis 102 is therefore after this held very firmly in position in the main body and is unable to move , thereby assisting in providing great accuracy for the dose counter 36 . next , as shown in fig8 d , the dose counter chamber cover 120 may be fitted over the dose counter chamber 66 and may be secured in place such as by welding , with the priming dot 216 being displayed through the window . the user can , when readying the inhaler 12 for first use , prime the inhaler by depressing the canister 20 three times which will bring the first number 114 on the tape into display through the window 118 in place of the priming dot 216 , the number 114 shown in fig8 d being “ 200 ”, thereby indicating that 200 doses are remaining to be dispensed from the canister 20 and inhaler 12 . as shown in fig8 d , and in fig5 , an open drain hole 194 is provided at the bottom of the dose counter chamber 66 by a substantially semi - circular cut - out or recess formation 196 in a lower surface 198 of the main body 10 of the inhaler . accordingly , if the user ( not shown ) should decide to wash the main body 10 of the inhaler , for example after encountering an unhygienic situation or simply as a matter of choice , the drain hole 194 allows initial draining of water from inside the dose counter chamber 66 and also thereafter evaporation of water or any aqueous matter in the dose counter chamber 66 so that the window 118 does not mist up undesirably . fig1 shows a computer system 230 for designing the dose counter 36 and in particular for calculating distributions representative of average positions and standard deviations in a production series of inhalers of the start , reset , fire , count and end positions of the actuator lower side edge 98 relative to the datum plane 220 ( fig9 ) and therefore of the actuator pawl 80 generally relative to the ratchet wheel 94 , chassis 102 and , when the inhaler 12 is fully assembled , the main body 10 of the inhaler 12 . the computer system 230 includes a data store 232 , a cpu 234 , an input device 236 ( such as a keyboard or communication port ) and an output device 238 ( such as a communications port , display screen and / or printer ). a user may enter data via the input device 236 which may be used by the cpu 234 in a mathematical calculation to predict count failure rates when the various dose counters are to be built in a series with dose counter positions set with given averages and standard deviations and taking into account any momentum / inertia effects and metering valve user - back - pressure reduction effect which will occur upon canister firing of a given type of canister . the computer system 230 is thus mathematically used to design the distributions . for the inhaler 12 described herein with the dose counter 36 and canister 20 , the distributions are designed as shown in fig1 . the x axis shows distance of the lower side surface 98 of the actuator 80 above the datum plane 220 and the y axis is representative of the distribution . thus , curve 240 shows that the start configuration has an average 1 . 33 mm above the datum plane 200 ( standard deviation is 0 . 1 mm ), curve 242 shows that the reset configuration has an average of 0 . 64 mm above the datum plane 220 ( standard deviation is 0 . 082 mm ), curve 244 shows the fire configuration has an average 0 . 47 mm below the datum plane 220 ( standard deviation is 0 . 141 mm ), curve 246 shows the count configuration has an average 0 . 95 mm below the datum plane 220 ( standard deviation is 0 . 080 mm ), and curve 248 shows the end configuration has an average of 1 . 65 mm below the datum plane 220 ( standard deviation is 0 . 144 mm ). fig1 to 20 show a version of the inhaler modified in accordance with the present invention . in these drawings , the same reference numerals have been used to those in the earlier drawings to denote the equivalent components . the inhaler 12 is the same as that in fig1 to 14 apart from the following modifications . first , it can be seen that there is a modification in that the drive teeth 92 of the ratchet wheel 94 have a different profile to that in fig1 to 14 . there are also only nine ratchet teeth 94 in this embodiment instead of eleven . additionally , as shown in fig1 c and 19c , the control elements 128 , 130 on the forks 124 , 126 of the second shaft 108 have a tapered profile which is different to the profile of the control elements 128 , 130 shown in fig6 f . either profile can be used in the embodiment of fig1 to 20 however . furthermore , as shown in fig1 , the tape stock bobbin 110 has an inwardly facing generally cylindrical engagement surface 300 with a wavelike form extending partially therealong . the engagement surface 300 has a cross - section 301 perpendicular to the longitudinal length of the stock bobbin 110 which is constant therealong . this cross - section 301 can be seen in fig1 and consists of a series of ten regularly spaced concavities 302 and ten convex wall portions 304 . the convex wall portions 304 are equi - spaced between the concavities 302 . each concavity 302 has a radius of 0 . 2 mm . each convex wall portion 304 also has a radius of 0 . 2 mm . finally , the cross section 301 also includes flat wall portions 306 between all of the radiused wall portions of the concavities 302 and convex wall portions 304 . the geometry of the cross - section 301 is therefore defined by the radii of the concavities 302 and convex wall portions 304 , the flat wall portions 306 and the fact that there are ten concavities 302 and convex wall portions 304 . the minor diameter of the engagement surface 300 , i . e . between the tips of opposite convex wall portions 304 , is 2 . 46 mm . the major diameter of the engagement surface 300 , i . e . between the outermost portions of the concavities 302 , is 2 . 70 mm . the undeformed tip to tip maximum diameter of the forks 124 , 126 of the split pin ( the second shaft ) 108 , i . e . in the region of the maximum radio extent of the control elements 128 , 130 , is 3 . 1 millimeters and it will therefore be appreciated that the forks 124 , 126 are resiliently compressed once the stock bobbin 110 has been assembled onto the split pin 108 in all rotational configurations of the stock bobbin 110 relative to the split pin 108 . the minimum gap between the forks 124 , 126 in the plane of the cross sections of fig1 c and 19c is 1 mm when the split pin 108 is in the undeformed , pre - inserted state . when the split pin 108 is at maximum compression , as shown in fig1 a to 18c when the control elements 128 , 130 are shown to be engaged on top of the convex wall portions 304 , the gap 308 between the tips 310 , 312 of the forks 124 , 126 is 0 . 36 mm . on the other hand , when the split pin 108 is at minimum compression ( once inserted into the stock bobbin ) as shown in fig1 a to 19c , when the control elements 128 , 130 rest in the concavities 302 , the gap between the tips 310 , 312 of the forks 124 , 126 is 0 . 6 mm . the control elements 128 , 130 are outwardly radiused with a radius also of 0 . 2 mm such that they can just rest on the concavities 302 with full surface contact ( at least at an axial location on the split pin where the tapered control elements are at their maximum radial extent ), without rattling in , locking onto or failing to fit in the concavities 302 . the radii of the control elements 128 , 130 is therefore preferably substantially the same as the radii of the concavities 302 it will be appreciated that whereas fig1 b and 19b are end views along the coaxial axis of the stock bobbin 110 and split pin 108 , fig1 a and 19a are cross - sections . fig1 a is a section on the plane a - a ′ in fig1 c and fig1 a is a section at the same plane , but of course with the stock bobbin 110 rotated relative to the split pin 108 . as the inhaler 12 is used and the ratchet wheel 94 rotates in order to count used doses , the stock bobbin rotates incrementally through rotational positions in which rotation is resisted , i . e . due to increasing compression of the split pin 108 at such rotational positions , and rotational positions in which rotation is promoted , i . e . due to decreasing compression of the split pin 108 at such rotational positions and this may involve a click forward of the stock bobbin 110 to the next position equivalent to that in fig1 a to 19c in which the control elements 128 , 130 of the split pin art located in the concavities 302 . this functionality firstly allows the stock bobbin to unwind during use as required , but also prevents the tape 112 from loosening during transit if the inhaler 12 is dropped , such as onto a hard surface . this is highly advantageous , since the tape 11 is prevented from moving to a position in which it will give an incorrect reading regarding the number of doses in the canister . during compression and expansion of the forks in the radial direction between the two configurations shown in fig1 c and 19c , the forks 124 , 126 rotate about a point 316 on the split pin where the forks 124 , 126 come together . this rotational action means that there is a camming action between the forks 124 , 126 and the engagement surface 300 without significant friction but , nevertheless , the resilient forces provided by the regulator formed by the engagement surface 300 and forks 124 , 126 are able to regulate unwinding of the tape such that it does not easily occur during transit or if the inhaler 12 is dropped . it has been found during testing that a force of 0 . 3 to 0 . 4 n needs to be applied to the tape 112 to overcome the regulator at the stock bobbin 110 . 0 . 32 n is achieved with the control elements 128 having the profile shown in fig1 c and 0 . 38 n is achieved with the profile of the control elements 128 altered to be as shown as described with reference to fig6 f . these forces are substantially higher than the 0 . 1 n force mentioned above and undesirable movement of the tape is substantially avoided even if the inhaler is dropped onto a hard surface . the modified arrangement of fig1 to 20 does not provide this force “ constantly ” such that there is overall not an undesirably high friction of the tape 112 as it passes over the other components of the dose counter because , due to the incremental nature of the resilient forces at the regulator , the tape 112 can incrementally relax as it slides over the stationary chassis components . instead of having ten concavities 302 and convex wall portions 304 , other numbers may be used , such as 8 or 12 . however , it is preferred to have an even number , especially since two control elements 128 , 130 are provided , so that all of the control elements 128 , 130 will expand and contract simultaneously . however , other arrangements are envisaged with 3 or more forks and the number of concavities / convex wall portions may be maintained as an integer divisible by the number of forks to maintain a system with simultaneous expansion / contraction . for example , the use of 9 , 12 or 15 concavities / convex wall portions with 3 forks is envisaged . instead of having the engagement surface 300 on the inside of the stock bobbin 110 , it could be placed on the outside of the stock bobbin 110 so as to be engaged by flexible external legs / pawls or similar . it will be noted that the regulator provided by the engagement surface 300 and forks 124 , 126 does not only allow rotation of the stock bobbin in one direction as is the case with the ratchet wheel 94 . rotation in both directions is possible , i . e . forwards and backwards . this means that during assembly , the stock bobbin 110 can be wound backwards during or after fitting the bobbin 100 , shaft 106 and tape 112 onto the carriage 102 , if desired . the stock bobbin 110 and the carriage 102 including the split pin 108 are both moulded of polypropylene material . it will be seen from fig1 that the cross - sectional shape 301 is not symmetrical within the hexagonal socket 204 . this has enabled the hexagonal socket 204 to be maintained at a useful size while still allowing the desired size and geometry of the cross section 301 to fit without interfering with the hexagonal shape of the hexagonal socket 204 and also permits moulding to work during manufacture . as shown in fig1 , the stock bobbin 110 has a series of four circumferential ribs 330 inside it and a spaced therealong . these hold the stock bobbin 110 on the correct side of the mould tool during moulding . fig2 and 22 show a preferred embodiment in accordance with the invention of an inhaler 510 for dispensing a dry - powdered medicament in metered doses for patient inhalation . the inhaler 510 is as disclosed in fig1 to 16 or ep - a - 1330280 , the contents of which are hereby fully incorporated herein by reference , but with the stock bobbin 110 and second shaft 108 of the dose counter 516 modified so as to be as in fig1 to 20 hereof . thus , the dry powder inhaler 510 generally includes a housing 518 , and an assembly 512 received in the housing ( see fig2 ). the housing 518 includes a case 520 having an open end 522 and a mouthpiece 524 ( fig2 ) for patient inhalation , a cap 526 secured to and closing the open end 522 of the case 520 , and a cover 528 pivotally mounted to the case 520 for covering the mouthpiece 524 . as shown in fig2 , the inhaler 510 also includes an actuation spring 569 , first yoke 566 with opening 572 , bellows 540 with crown 574 , a reservoir 514 , second yoke 568 with hopper 542 and dose counter 516 mounted thereto , and case 520 has transparent window 5130 thereon for viewing dose counter tape indicia 5128 . the dose metering system also includes two cams 570 mounted on the mouthpiece cover 528 and movable with the cover 528 between open and closed positions . the cams 570 each include an opening 580 for allowing outwardly extending hinges 582 of the case 520 to pass therethrough and be received in first recesses 584 of the cover 528 . the cams 570 also include bosses 586 extending outwardly and received in second recesses 588 of the cover 528 , such that the cover 528 pivots about the hinges 582 and the cams 570 move with the cover 528 about the hinges 582 . as described in ep - a - 1330280 , cams 570 act upon cam followers 578 to move second yoke 568 up and down and thereby operate dose counter by engagement of pawl 5138 on the second yoke 568 with teeth 5136 . remaining components of the inhaler are provided as , and operate as described , in ep - a - 1330280 . the dose counting system 516 therefore includes a ribbon or tape 5128 ( fig2 & amp ; 24 ), having successive numbers or other suitable indicia printed thereon , in alignment with a transparent window 5130 provided in the housing 18 ( see fig2 ). the dose counting system 516 includes the rotatable stock bobbin 110 ( as described above ), an indexing spool 5134 rotatable in a single direction , and the ribbon 5128 rolled and received on the bobbin 110 and having a first end 5127 secured to the spool 5134 , wherein the ribbon 5128 unrolls from the bobbin 110 so that the indicia are successively displayed as the spool 5134 is rotated or advanced . in fig2 and 24 the wavelike engagement surface 300 of the bobbin 110 is not shown for the purposes of clarity . the spool 134 is arranged to rotate upon movement of the yokes 566 , 568 to effect delivery of a dose of medicament from reservoir 514 , such that the number on the ribbon 5128 is advanced to indicate that another dose has been dispensed by the inhaler 510 . the ribbon 5128 can be arranged such that the numbers , or other suitable indicia , increase or decrease upon rotation of the spool 5134 . for example , the ribbon 5128 can be arranged such that the numbers , or other suitable indicia , decrease upon rotation of the spool 5134 to indicate the number of doses remaining in the inhaler 510 . alternatively , the ribbon 5128 can be arranged such that the numbers , or other suitable indicia , increase upon rotation of the spool 5134 to indicate the number of doses dispensed by the inhaler 10 . the indexing spool 5134 includes radially extending teeth 5136 , which are engaged by pawl 5138 extending from a cam follower 578 of the second yoke 568 upon movement of the yoke to rotate , or advance , the indexing spool 5134 . more particularly , the pawl 5138 is shaped and arranged such that it engages the teeth 5136 and advances the indexing spool 5134 only upon the mouthpiece cover 528 being closed and the yokes 566 , 568 moved back towards the cap 526 of the housing 518 . the dose counting system 516 also includes a chassis 5140 that secures the dose counting system to the hopper 542 and includes shafts 108 , 5144 for receiving the bobbin 110 and the indexing spool 5134 . as described above with reference to fig1 to 20 , the bobbin shaft 108 is forked and includes radially nubs 5146 for creating a resilient resistance to rotation of the bobbin 110 on the shaft 108 by engaging with the wavelike engagement surface 300 inside the bobbin 110 . a clutch spring 5148 is received on the end of the indexing spool 5134 and locked to the chassis 5140 to allow rotation of the spool 5134 in only a single direction . various modifications may be made to the embodiment shown without departing from the scope of the invention as defined by the accompanying claims as interpreted under patent law .

US-201615269249-A

the invention comprises a ski having at least one lower cover , at least one upper cover , a core disposed between the upper cover and the lower cover , the core including recessed grooves in a side thereof proximate the upper cover and strip - shaped receiving parts disposed in the grooves . the receiving parts include at least two layers , one of the two layers including metal , and the other of the at least two layers including an elastomeric material , and spacer sleeves extending through the elastomeric material layer and including distal ends which extend beyond the upper cover . the distal ends are for bearing a base plate thereon and the spacer sleeves are for receiving fastening screws to connect the base plate with the receiving parts .

in the case of the embodiment according to fig1 and 2 , strip - shaped receiving parts 2 are inserted into the core 1a of a ski 1 in grooves 6 in each case and are connected to the core 1a , e . g . by adhesion or vulcanizing . in this case , a separate receiving part 2 is provided for each screw 7 for the fastening of the base plate 8 . the core 1a of the ski 1 is surrounded by an upper chord 4 , which , as can be seen from fig2 is formed from an aluminum layer 9 , a glass fiber reinforced laminate 10 and a surface coating 11 , a lower chord 5 , which is usually formed from an aluminum layer , which is bounded laterally by the steel edges 5a , and a running coating 5b , as well as the two side cheeks 3 . in this case , the receiving parts 2 , as evident from fig1 are covered by the upper chord . in the case of the exemplary embodiment represented in fig1 and 2 , the receiving parts 2 are built up in five layers . in this case , the uppermost and the lowermost layer 12 and 13 , respectively , are produced from an elastomeric material , such as e . g . rubber or silicone rubber , as is the middle layer 14 . these layers 12 , 13 , 14 are separated from one another by two layers 16 , 17 of metal , in particular of an aluminum alloy . the fastening screws 7 pass through the two aluminum layers 16 , 17 . on the upper aluminum layer 16 there rests a spacer sleeve 18 , which passes through the upper layer 12 of an elastomeric material and the upper chord 4 , the latter with play , and protrudes by a small amount beyond the upper side of the latter . on these spacer sleeves 18 lies the base plate 8 ; it is kept by the spacer sleeves 18 at a small distance from the upper side of the ski . in this case , each fastening screw 7 runs within the spacer sleeve 18 with its smooth shank , in order to make a relative movement possible . the receiving parts 2 are surrounded by an intermediate liner 19 , one each surrounding their side walls , of an elastomeric material , which fills the space between the side walls of the groove 6 and of the receiving part 2 . in this case , the intermediate liner 19 may be bonded both to the side walls of the groove 6 and also to the receiving part 2 by adhesion or vulcanizing . by the intermediate liners 19 and the elastomeric layers in the receiving parts 2 , a mutual displacement of the base plate 8 and of the ski is made possible , as a result of which a stiffening of the ski 1 by the fitting of the base plate 8 is avoided and also a transfer of vibrations from the ski to the binding is largely damped . the embodiment according to fig3 and 4 differs from that according to fig1 and 2 in that each receiving part 2 &# 39 ; has a metal layer 16 &# 39 ;, which is sheathed on all sides by an elastomeric material 12 &# 39 ;, such as e . g . rubber or silicone rubber . the receiving parts 2 &# 39 ; extend , as also in the case of the exemplary embodiment according to fig1 and 2 , in longitudinal direction of the ski 1 in the region of the zones provided for the fastening of the binding , as a result of which an adaptation of the binding in longitudinal direction of the ski becomes possible . in the case of the embodiment according to fig3 and 4 , a layer 20 of sponge rubber is inserted between the upper side of the ski 1 and the base plate 8 , which layer prevents the ingress of water , snow and ice into this intermediate space , which could impair the mutual mobility of the base plate 8 with respect to the ski 1 . according to fig5 and 6 , the ski 31 consists of a core 31a , which is covered on its upper side by a metal layer 39 and is surrounded over its entire circumference together with the metal layer by a torsion box 34 . on the underside , the torsion box 34 is covered by a lower chord 35 , which consists of a running coating 35b and of a metal layer 35c , which are embraced laterally by steel edges 35a . laterally , side cheeks 33 are attached on the torsion box 34 . on the upper side of the torsion box 34 lies an upper chord 40 , which is covered by a surface coating 41 . the design of such a ski 31 is known per se and does not form a subject of the invention . in the core 31a , two upwardly open grooves 36 are recessed , into which receptacles 49 are inserted , which are likewise upwardly open and are firmly bonded , for example adhesively bonded , to the core 31a . into each receptacle 49 there is inserted a receiving part 32 , which is made up of a plurality of layers 42 - 47 . this receiving part 32 serves to receive the fastening screws 37 of a ski binding 56 , only indicated . each receiving part 32 consists of -- considered from top to bottom -- a layer 45 of rubber or the like , of a first layer 42 of glass fiber reinforced plastic , of an aluminum plate 46 , of a second layer 44 of glass fiber reinforced plastic , of a further aluminum plate 47 and of a third layer 43 of glass fiber reinforced plastic . the individual layers 42 - 44 and the plates 46 , 47 are bonded to one another , e . g . by adhesion , and form a block . the uppermost layer of the receiving part 32 , namely the layer 45 of rubber or the like , is provided with a row of vertical holes 52 or of recesses , extending in longitudinal direction of the ski 31 . furthermore , vertically running grooves 53 are recessed in the longitudinal sides of the layer 45 ( see fig1 ). each receptacle 49 has , in plan view , the form of a rectangle , the shorter sides of which are replaced by semicircles ( see fig7 ). between the two longitudinal side walls of the receptacle 49 there extend ribs 51 , running in transverse direction , which are also firmly connected to the bottom and the height of which corresponds approximately to one third of the height of the receptacle 49 . these ribs 51 serve to support the receiving part 32 , which rests with its lowermost layer 43 on the ribs 51 . at its upper side , the receptacle 49 is closed off by means of a cover 55 . in order to fix the smallest distance of the base plate 56a of the ski binding 56 relative to the plate layers 46 , 47 , bushes 48 are provided , which pass through both the layer 45 of elastomeric material and also the cover 55 with play and which lie with their lower ends on the block , which is formed by the layers 42 to 44 , 46 and 47 . the bushes 48 are riveted to a bush plate 38 , which lies on the ski upper side . according to fig5 the ski binding 56 is fastened on the ski 31 by means of its base plate 56a by screws 37 , which pass through the bush plate 38 and the bushes 48 with their smooth shanks . in this case , the screw 37 represented on the left in this figure is represented directly after the insertion into the bush 48 and the right screw 37 is represented after the tightening of the ski binding 56 . it also emerges from the figure that , in the tightened state , although the screw 37 passes through all layers 42 - 47 of the receiving part 32 , it protrudes with its end into the intermediate space between two ribs 51 , which consequently forms a free space 54 . a damaging of the bottom of the receptacle 49 by the screws 37 therefore does not take place . in the case of the variant according to fig1 , the longitudinal axes of the two grooves 36 &# 39 ; are arranged at an angle to the vertical longitudinal center plane of the ski 31 . as a result , it is ensured that also ski bindings on which the forward and rear receiving locations of the fastening screws are provided in pairs with different spacings can be fastened . this development can be used in particular in the case of hire - ski bindings , on which the base plates are fixed -- with respect to the length of the ski -- from the outset . the invention is not bound to the exemplary embodiments represented in the drawing and described above . rather , various modifications of the same are possible without departing from the scope of the invention . for example , the receptacle may also be provided with more than three ribs . also , the development according to the invention of the receiving part may be used in conjunction with a differently shaped ski . furthermore , according to the invention it is possible , instead of two grooves , to recess three or more grooves , which are offset -- seen in ski longitudinal direction and / or in ski transverse direction . such grooves may also be arranged in alignment . in this way , ski bindings with different screw arrangements can be fixed on the ski . furthermore , it is possible to fill the space above the bottom of the receptacle with elastomeric rubber to about one third of the receptacle height and to dispense with the arrangement of ribs . the recesses provided to improve the deformability of the flexible layer may have a hemispherical shape or be designed as blind bores . it is , however , also possible , instead of recesses , to produce the entire flexible layer of a porous rubber material , e . g . of sponge rubber .

US-38061089-A

a novel calcium complex for the fortification of beverages and foods , especially milk , is disclosed . fortifying complexes are made of a calcium source and a negatively - charged emulsifier with or without an organic or inorganic acid or a salt thereof . these complexes have been found to be particularly effective in fortifying milk and milk - protein containing beverages without coagulation of the proteins or without significantly changing the texture of the product .

the calcium source that is primarily used to create this complex can include calcium hydroxide , calcium carbonate , calcium chloride , calcium phosphate , calcium sulfate , calcium nitrate , calcium lactate , calcium fumarate , calcium citrate , calcium acetate , calcium glycerophosphate or calcium oxide but is preferably calcium hydroxide . the use of an alkaline source , such as calcium hydroxide , advantageously neutralizes the ph of the complex . if a non - alkaline calcium source is used , then an alkaline agent must be added to neutralize the ph of the complex , of which any food grade alkaline agent can be utilized . the negatively - charged emulsifiers that can be used to form the complex include but are not limited to citric acid esters of monoglycerides citrem , ( danisco ingredients , inc ., new century , kans . ), stearoyl lactylate ( sodium , calcium , or acid ), enzyme modified lecithin , stearyl citrate , fatty acids and their salts , or diacetyl tartaric acid esters of monoglycerides . citrem is most preferred . the emulsifiers used are not limited to those of a single acyl or fatty acid component , such as on a specific carbon chain length or degree of unsaturation . the emulsifier used is preferably hydrated , making the emulsifier more dispersable , and allowing easier exchange with cations . this can be accomplished by various means dependent on the type of emulsifier used , and are commonly known to those familiar with the art . for example , a common method of hydration is by heating a slurry of emulsifier and water to above 70 ° c . for a period of time ( generally more than 10 min ). once hydrated , the emulsifier dispersion is cooled to near room temperature . any one of a number of acids can be used including organic acids such as citric , lactic , malic , fumarate , gluconic , succinic , tartaric , or ascorbic , or inorganic acids such as phosphoric . salts of these acids that can be utilized include potassium , sodium , or calcium salts of the aforementioned acids . for this invention , the most preferred acid is citric acid . optionally , the complex may be dried and , if desired , stored before further use for fortification of a foodstuff . the amounts needed to form the complex are not critical provided that sufficient amounts of each component are present . simple mixing of the components is sufficient to form the complex . when an acid is not used in the complex , the weight ratio of calcium ( from the calcium source ) to surfactant should range from 1 : 10 to 10 : 1 , and preferably from 2 : 1 to 1 : 2 . when an acid is used in the complex , the weight ratio of acid to calcium should range from 5 : 1 to 1 : 5 , and preferably from 2 : 1 to 1 : 2 , while the weight ratio of calcium to surfactant can range from 100 : 1 to 1 : 5 . the components are preferably dissolved in water to facilitate mixing and complex formation . the concentration of the solutions is preferably 1 - 5 % by weight or greater . the person of ordinary skill in the art can readily determine convenient amounts to use for any particular application the complex may conveniently be formed by the interaction of a suitable calcium source , a negatively charged emulsifier , with or without an organic or inorganic acid or a salt thereof . for example , the complex may be prepared by adding acid or a salt of an acid to the emulsifier with mixing , and then adding the calcium source . when an alkaline calcium source such as calcium hydroxide is added , the ph of the system is neutralized . alternately , a non - alkaline calcium source can be added , followed by the neutralization with alkaline agent . any food grade alkaline agent may be used for neutralization including but not limited to sodium hydroxide , potassium hydroxide , magnesium hydroxide , sodium carbonate , sodium bicarbonate , potassium carbonate and potassium bicarbonate . the present invention also provides a fortified foodstuff with a fortifying amount of a complex comprising calcium and a negatively - charged emulsifier with or without an organic or inorganic acid or a salt thereof . the foodstuff may be a dairy based product such as a milk beverage , a liquid nutritional product or other beverage such as a juice , or a confectionary product such as ice cream . the fortified foodstuff comprising a fortifying amount of a complex may be prepared by forming a complex and adding the complex to the foodstuff . the foodstuff can then be heat treated by normal means without any loss in quality such as precipitation , coagulation , or fouling of processing equipment . the resulting fortified foodstuff is similar to its unfortified counterpart in organoleptic quality . it has a similar color and taste , without major changes to the texture , viscosity or mouthfeel of the foodstuff . the amount of complex to add to the foodstuff is not critical and is dependent upon the calcium content of the complex and the desired level of fortification . typically , enough of the complex would be added to fortify the foodstuff from 5 % to 200 % of the recommended daily allowance for calcium , although even greater amounts are possible , if desired . advantageously , a stabilizer may be added to the foodstuff , preferably before the complex is added to the foodstuff . the stabilizer may be added to the foodstuff in the form of an aqueous solution or suspension or as a dry powder . stabilizers that may be used may include but are not limited to carrageenan , xanthan , gellan , pectin , alginates , gumarabic , carboxymethylcellulose , modified and unmodified starches , propylene glycol alginate , locust bean gum , guar gum , hydroxylpropyl cellulose , hydroxypropylmethyl cellulose , methyl cellulose or mixtures of two or more thereof . preferably for dairy products , carrageenan is used as a stabilizer . the following examples further illustrate the present invention . in the tables , the abbreviations “ sed ”, “ emul ”, “ sl ” and “ gd ” mean “ sediment ”, “ emulsion ”, “ slight ” and “ good ” respectively . the following example is intended to demonstrate that a variety of emulsifiers and / or calcium sources can be effective in preparing these complexes . complexes for fortification of milk were prepared according to the following formulations : emulsifier was mixed with 50 ml water , the dispersion was heated to 150 ° f ., and then cooled to 100 ° f . for samples 1 - 3 , a solution of the acid in 10 ml water was then added to the hydrated emulsifier with vigorous mixing . for samples 4 and 5 , the acid was added directly to the hydrated emulsifier with vigorous stirring . when applicable , a dispersion of the calcium source in 10 ml water was then added to the emulsifier - acid suspension with vigorous stirring . 6 . 6 g non - fat dry milk was added to 700 ml of skim milk under agitation . the resulting complex was added with vigorous stirring to sufficient skim milk ( at 120 ° f .) to bring the final volume of calcium fortified milk to 750 ml . the ph of the milk was adjusted to 7 . 0 using a 30 % sodium hydroxide solution as needed . the milk was then homogenized at a total pressure of 2500 / 500 psi using a two - stage apv rannie ® homogenizer . the fortified milk was filled into 125 ml baby food jars , pasteurized at 163 ° f . for 15 sec , cooled rapidly in a ice water bath , then stored in a refrigerator . samples were evaluated for sedimentation and taste after 1 week and for sedimentation after 2 weeks . i ) a slurry of 450 g citrem ® was mixed with 15 kg water at room temperature for 60 min . the suspension was heated to 165 ° f . and held at that temperature for 10 min with agitation , then cooled to 90 ° f . ( suspension # 1 ). a solution of 544 . 5 g citric acid in 6 . 1 kg water was prepared by mixing at room temperature ( solution # 2 ). a sodium hydroxide suspension was prepared by mixing 333 . 0 g calcium hydroxide in 5 , 000 g water at room temperature ( suspension # 3 ). solution # 2 was added to suspension # 1 and mix well for 60 min . suspension # 3 was then added and the resulting suspension was mixed for 60 min . ii ) to 10 kg skim milk at 40 - 60 ° f ., 45 . 0 g carrageenan ( seakem cm611 , fmc corporation , philadelphia , pa .) was added with mixing for 5 min . the milk was then heated to 165 ° f . and held at 165 ° f . for 5 min under agitation . iii ) to 260 kg skim milk , 2505 . 0 g non - fat dry milk ( nfdm ) was added at 40 - 60 ° f . and the milk was mixed for 10 min . the milk was then heated to 120 ° f ., and the carrageenan / milk mixture ( ii ) was added slowly and the resulting milk was mixed for 5 min . the milk was heated to 149 ° f . and held for 5 min . the milk was cooled to 90 ° f . and the calcium complex was added slowly . the resulting calcium fortified milk was mixed for 10 min and 22 . 5 g cream / milk flavor was added . the ph of the milk was adjusted with 10 % potassium hydroxide solution to 6 . 9 - 7 . 0 . the solids content was checked . the calcium fortified milk was homogenized at 120 ° f . and pressure 25000 / 500 psi . the milk was then pasteurized at 163 ° f . for 15 sec and filled into 330 ml glass bottles . the bottles of milk were then cooled in cold water and stored under refrigeration at 40 ° f . calcium fortified milk was pre - heated to 160 ° f ., then heated to 285 ° f . and held at 285 ° f . for 5 sec , and cooled to 160 ° f . the milk was then homogenized at pressure 2500 / 500 psi , cooled to 60 ° f . and filled in 250 ml tetra brik aseptic packages ( tetra pak inc ., chicago ). calcium fortified milk was pre - heated to 175 ° f ., then heated to 285 ° f . by steam injection , held at 285 ° f . for 5 sec , and cooled to 175 ° f . the milk was homogenized at pressure 2500 / 500 psi , cooled to 60 ° f . and filled in 250 ml tetra brik aseptic packages ( tetra pak inc ., chicago ). calcium fortified milk was pre - heated to 160 ° f ., then heated to 298 ° f . by plate heat exchangers and held at 298 ° f . for 5 sec , and cooled to 160 ° f . the milk was homogenized at pressure 2500 / 500 psi , cooled to 60 ° f . and filled in 250 ml tetra brik aseptic packages ( tetra pak inc ., chicago ). calcium fortified milk was pre - heated to 175 ° f ., then heated to 298 ° f . by steam injection , held at 298 ° f . for 5 sec , and cooled to 175 ° f . the milk was homogenized at pressure 2500 / 500 psi , cooled to 60 ° f . and filled in 250 ml tetra brik aseptic packages ( tetra pak inc ., chicago ). *% sediment was determined from sediment weight after centrifugation at 1800 g far 5 min and drying of resulting pellet at room temperature overnight ** total calcium content was determined using a leeman labs , model ps 1 aes - icp spectrometer after dry ashing and ash dissolving in nitric acid and water ( 1 : 1 ) *** flocculation was determined by visual inspection . milk was boiled 15 sec then placed immediately on the convexed surface of a watch glass for inspection to 25 kg water at 185 ° f ., 720 g citrem were added and mixed for 5 min , then cooled to 110 ° f . while under agitation 871 g citric acid was added , and the suspension was mixed for 5 min . 533 g calcium hydroxide was added under agitation and the complex was mixed for 60 min . steps ii , iii and iv from example 2 were then followed . *% sediment was determined from sediment weight after centrifugation at 1800 × g for 5 min and drying of resulting pellet at room temperature overnight ** total calcium content was determined using a leeman labs model ps 1 aes - icp spectrometer after dry ashing and ash dissolving in nitric acid and water ( 1 : 1 ) *** flocculation was determined by visual inspection . milk was boiled 15 sec then placed immediately on the convexed surface of a watch glass for inspection . other samples from example 3 performed very similarly to samples with corresponding heat treatments from example 2 . this example shows how the complex can be formed directly in milk . step 1 from example 2 was followed to prepare a calcium complex . to 275 kg milk at 40 - 60 ° f ., 45 . 0 g seakem cm 611 carrageenan was added with mixing . to the milk was added 2505 . 0 g nfdm , 22 . 5 g cream / milk flavor , the ca - complex and the resulting fortified milk was mixed for 5 min . the ph was adjusted with 10 % potassium hydroxide solution to 6 . 9 - 7 . 0 . the solids content was checked . step iv from example 2 was then followed . samples from example 4 performed very similarly to samples with corresponding heat treatments from example 2 . to 800 g water at 185 ° f ., 24 . 0 g citrem was added and mixed for 5 min , then cooled to & lt ; 110 ° f . while under agitation , 29 . 0 g citric acid was added and mixed for 5 min . calcium hydroxide ( 17 . 77 g ) was added under agitation and resulting complex was mixed for 60 min . to 300 g skim milk at 40 - 60 ° f ., 1 . 5 g seakem cm 611 carrageenan was added and the milk mixed for 5 min . the milk was then heated to 165 ° f . and held at 165 ° f . for 5 min under agitation . to 8 . 9 kg skim milk at 40 - 60 ° f ., 83 . 5 g nfdm was added and the milk was mixed for 10 min . milk was heated to 120 ° f . and the carrageenan / milk was added slowly and mixed for 5 min . milk was heated to 149 ° f ., held at that temperature for 5 min , then cooled to 90 ° f . the calcium complex was added slowly , the milk was mixed for 10 min , and 0 . 75 g cream / milk flavor was added . the ph was adjusted with 10 % potassium hydroxide solution to 6 . 9 - 7 . 0 . the solids content was checked . the calcium fortified milk was placed in 330 ml glass jars , autoclaved for 5 min at 250 ° f . then cooled to room temperature . the autoclaved milk fortified with ca - citrem - citric acid complex at a total calcium level of 2160 ppm performed similarly to the uht sterilized samples — see example 2 , uht sterilization ( si ).

US-45734299-A

a device for indicating the presence of an electrical path on a pet accessory includes a first contact disposed on a probe , and a second contact disposed in a spaced apart arrangement relative to the first contact . an activation device is responsive to the presence of an electrical path or lack thereof between the first and second contacts . the activation device provides an indication of the state of the electrical path between the first and second contacts . the device preferably includes a pet dish and the probe extends into the dish to indicate a desired level for liquid in the dish , and the indication of state is performed by at least one of an audio message , a visual effect and a mechanical motion .

the present invention provides pet accessories , which communicate to humans , the needs of their pets . in one embodiment , a combination wind blocker / indicator that the pet must go out is provided . in another embodiment , a device for determining the level of liquid in a pet dish is provided , which alerts people in the vicinity that the liquid levels are low . in still other embodiments , pet or human leashes , collars , cuffs or straps are provided with a plurality of accessories . for example , a combination leash and radio is provided . other leashes include powered lights and / or reflectors . the powered lights may include optical fibers woven into the leash . the reflectors may include heat stamped designs stamped onto the material of the leash . other devices disclosed herein include teether designs , which may include edible portions . these edible portions may include nutritional supplements or medications for the pet . the present invention will now be described in greater detail with reference to illustrative examples . it is to be understood that the present invention is not limited to the illustrative examples and may be employed with other configurations within the scope and spirit of the present invention . referring now in specific detail to the drawings in which like reference numerals identify similar or identical elements throughout the several views , and initially to fig1 a pet reminder device 10 is shown in accordance with one embodiment of the present invention . device 10 preferably includes a soft flexible outer surface 12 . device 10 includes at least one elongated portion 11 . elongated portion 11 may include a height of a few inches and a length of about 3 feet to be suitable as , for example , a wind / draft blocker at the base of a door 9 . other dimensions are also contemplated . device 10 includes weighted portions 14 , which may include a non - skid material 16 , such as rubber , to prevent device 10 from being easily dragged . alternately , device 10 may have its weight distributed throughout , and material 16 may be continuous on elongated portion 11 . weighted portions 14 may include materials 15 , such as polyethylene , or any other material , which provides weight to device 10 without endangering a pet &# 39 ; s health if ingested . elongated portion 11 preferably is filled with insulation material 18 ( e . g ., polyester , etc .). insulation material 18 prevents heat transfer from a dwelling or building from escaping / entering under a doorway when device 10 is employed as a wind / draft blocker . device 10 may include an ornamental portion 20 . ornamental portion 20 may include a dog &# 39 ; s head , a cat &# 39 ; s head , likenesses of famous characters , other animal or human forms , etc . device 10 preferably includes a washable surface and may include different textures , such as a smooth texture ( e . g ., vinyl ), a furry texture , etc . other portions of device 10 can be ornamented as well . in one embodiment , portion 20 provides an attachment 21 to a pad 22 . attachment 21 between portion 20 and pad 22 may include arrangements , such as a hook and loop arrangement ( e . g ., velcro ®), magnetic connections , mechanical connection ( e . g ., a zipper ), etc . pad 22 includes circuitry and mechanical switches , which can be activated by a pet to indicate that it is time for the pet to go out or indicate other pet needs or emotions . in an alternate embodiment , pad 22 is permanently fixed to portion 20 . however , having pad 22 detachable permits surface washing and / or easier maintenance of pad 22 . in addition , the use of pad 22 may be desired without elongated portions 11 and portion 20 . portion 20 or elongated portions 11 may include a loop 24 so that device 10 can be conveniently hung on a doorknob while the pet is being walked , etc . activation of pad 22 is completed by pressing one or more switches included therein . device 10 may also be employed as a wind blocker alone , with or without pad 22 . pad 22 may include lettering 44 thereon . lettering 44 may include a pet &# 39 ; s name , a saying or any other expression . referring to fig2 an exploded view of pad 22 is shown in accordance with the present invention . pad 22 preferably includes an outer surface or case 30 . case 30 preferably includes a machine washable fabric or a durable surface washable material . pad 22 includes a board 32 , which includes a plurality of switches 34 ( switches 34 are attached on the underside of board 32 ). board 32 is rotatably connected to a fulcrum 36 such that a simple teeter - totter effect is provided so that when a pet steps on pad 22 a mechanical advantage is gained to activate one or more switches 34 . in other words , no matter where the pet steps on pad 22 the top balance piece will tilt and / or pivot ( like a teeter - totter ) and activate one or more of switches 34 . switches 34 may include contact switches , which are biased in the open position . when switches 34 are closed a sound chip 38 on circuit card 40 is activated to indicate that the pet wishes to go out or to communicate other needs or emotions of the pet . a speaker 41 ( e . g ., a 29 mm speaker ) is employed to provide loud and clear sound in accordance with sound chip 40 . a power source 43 may include batteries or the ability to be plugged into a wall outlet . in one embodiment , the activated sound recorded in chip is a random selection of originally recorded voice phrases from an originally programmed chip . alternately , custom - made sound chips may be provided or the user may also program the recordings . chip 40 may include a random combination of phrases ( see , e . g ., phrases 1 - 11 on fig3 ). combinations a - k as shown in fig3 may be randomly selected by chip 40 when activated by closing one or more switches 34 . pad 22 includes an on / off switch 42 to turn pad on / off . alternate embodiments include lights or mechanical motion devices , which are activated by switches 34 in accordance with the pet &# 39 ; s triggering switches 34 . referring to fig3 and 4 , an illustrative flow chart for activation of chip 40 is shown . after activation in block 50 , combination a is played by chip 40 , followed by one of combinations b - k . the combinations b - k are randomly selected in chip 40 . after a delay , e . g ., 5 seconds , one of phrases 1 - 11 ( fig3 ) is played in block 52 , frequency of occurrence of phrases may be predetermined ( by percentage chance or otherwise ) or randomly selected . in block 54 , the unit waits for the next activation and returns to block 50 when activated . many other combinations , times , phrases and sequences are contemplated and would be useful in accordance with the present invention . these or other phrases and combinations may be played randomly or in a predetermined order . another way of communication by a pet may include indicating when a water dish needs to be filled . referring to fig5 a cross - sectional view of a liquid level indicator device 62 is shown in accordance with one embodiment of the present invention . a pet dish wall 60 has liquid level indicator device 62 attached thereto . device 62 may be integrally formed with dish 60 or attached to dish 60 by a plurality of different attachment mechanisms . these mechanisms may include mechanical snaps , clips , screws , rivets , magnetic pads ( for steel or iron dishes ), glue , etc . in one embodiment , device 62 is detachable from dish 60 . device 62 may include clasps or hooks 64 which are adapted to clip over a rim of dish 60 , and feet 66 which contact a side of dish 60 to provide attachment of device 62 to dish 60 . clasps 64 may provide a force against dish 60 to increase frictional forces and increase the stability of the attachment . device 62 includes a probe portion 68 , which extends over the rim of dish 60 to provide further stability if in contact with dish 60 . portion 68 includes contacts 70 , which sense a desired level of water or liquid 69 in dish 60 . in a preferred embodiment , liquid 69 in dish 60 provides a conductive path , which closes a circuit in device 62 . when liquid 69 drops below contacts 70 , the circuit is opened and a sound chip or light in device 62 is activated to indicate that more liquid needs to be added to dish 60 . device 62 includes a housing 74 , preferably including a plastic or water - resistant material and is sealed by gaskets or other water excluding devices . in one embodiment , an injection molded abs and / or pvc housing 74 is provided . contacts 70 may be insert molded to insert stainless steel or other compatible wire through probe portion 68 allowing at least two small and inconspicuous contacts to remain exposed . contacts 70 may be plated or coated with conductive materials to prevent corrosion . for example , contacts 70 may be gold plated . device 62 includes a sound module chip 80 ( fig6 ) with a recorded voice ( s ) which gives reminders when there is a lack of water or liquid in dish 60 . alternately , reminders may be given when the dish is full of liquid , empty or both . the programming of chip 80 ( fig6 ) permits a random selection of the sayings , expressions or sounds . in one embodiment , device 62 will activate one saying for example , then progress to a next saying in , say , 5 minutes if no water is added , then again in 10 minutes , then again in 15 minutes , then the unit will shut off . other times and sequences are also contemplated . device 62 may be employed as a feedback unit for detecting a level of water in a dish . device 62 may be attached to a water source and permit water to fill a dish by opening a valve 65 to permit water flow when a low level of water is detected . valve 65 is closed when water is replenished . water may be added either manually or by an automatic release . another device 63 may be activated upon a connection or lack of connection between contacts 70 . device 63 may be a spinner , a light , a container with a door that opens or closes based on the state of the contacts 70 ( e . g ., connected or not connected ) or any other audio , visual or mechanical motion device . in one embodiment , a connection maybe made between contacts 70 by a pet &# 39 ; s saliva , i . e ., by licking the contacts 70 . this may trigger , e . g ., a container of food to open , water to be released to fill the dish , or any other mechanical motion , audio or visual effect . referring to fig6 an illustrative circuit 91 is shown for implementing device 62 . contacts 70 are shown as a switch 73 . when switch 73 is open , chip 80 is activated which creates and audio sequences which is played over speaker 81 , e . g ., a 27 mm speaker . a valve switch or solenoid 75 may be included which is activated when switch is opened to provide water and closed when switch is closed . a battery or other energy source 71 is included for powering circuit 91 . an additional on / off switch can be provided to deactivate circuit 91 . other devices 63 or mechanical motions may be activated in accordance with the present invention . referring to fig7 and 8 , sound chip 80 can provide a plurality of different responses for device 62 . fig7 and 8 show illustrative responses for one embodiment of the present invention . fig7 shows phrases 1 - 9 ( for dogs ) and 1 a - 9 ( for cats ). phrases 1 - 9 ( and / or 1 a ) maybe randomly combined using chip 80 to provide combinations a - l . these audio responses are triggered in the manner described above . other responses , such as visual responses or mechanical motions may also be employed . fig8 shows an illustrative flow chart for implementing chip 80 . it is to be understood that the present invention may be employed for any pet , for example , dogs , cats , hamsters , birds , reptiles , rabbits , etc . larger units can be added to water troths of farm animals , etc . smaller units may remind owners to add water manually or by automatic water release into a fish tank as well . electrical contact or lack thereof of switch 73 may be employed be trigger food release , water release or other effects , such as activation of a spinner , raising a flag , opening a container , etc . referring to fig9 a teether 100 is shown in accordance with the present invention . teether 100 includes bumps 101 of insert - molded material and / or mixture of materials to create specific flavor or scents , which are pleasing to pets . for example , bumps 101 may include scented or flavored plastics , food or pet treats , which are molded into teether 100 . in addition , teether 100 may include edible sections 102 . teether 100 preferably includes a soft durometer material ( matrix ), e . g ., polyurethane , such as , injection molded virgin polyurethane , for massaging of the gums of newly cutting teeth of dogs , for example . with continual play the material and texture thereof can help keep teeth clean and eliminate tartar buildup in dogs . bumps or divots 101 and sections 102 may be insert molded into teether 100 or attached after molding . bumps 101 may include nutritional supplements or medication . bumps 101 may be manually added to teether / chew toy 100 or molded directly into toy 100 . referring to fig1 , reflective restraining devices 201 - 204 are shown . devices 201 - 204 may be employed as collars , leashes , or other restraints to be used on animals or humans . devices 201 - 204 may include , e . g ., nylon , cotton , leather and / or a polyester material decorated with multi - colored highly reflective materials . the highly reflective material may be patterned into dots 205 or other shapes . it is to be understood that the restraining devices as described herein as collars or leashes also include harnesses , straps , ( e . g ., bra straps ), belts or other materials which may be worn on a human or pet . in addition , the collars , leashes , restraining devices , etc . as described herein also include attachments or extenders for conventional restraining devices , i . e ., belt extenders , strap extensions or accessories that attaché to belts , collars , leashes , etc . referring to fig1 a - c , reflective material 210 is preferably manufactured in sheets of tinted clear material then backed by a solid opaque white vinyl 212 . special and unique shapes and designs may then be silk screened for added detail and heat die - cut from these sheets to cause the edges to seal together ( see top view of dot 205 in fig1 b ). the heat cut may also be designed to not cut all the way through , thus creating recessed areas 214 within the created shape to form additional details of such shape ( see e . g ., fig1 c ). referring to fig1 , and 11 a - c , die cut shapes or dots 205 are then applied to the nylon , cotton , leather or polyester materials 216 of leash by heat stamping and sealing in place . with the use of high temperature , the vinyl will melt and seal onto the desired material . the reflectivity of the material ( e . g ., reflective pvc ) 210 can be seen up to 500 ft when hit with a beam of light from oncoming cars , etc . leashes 201 - 204 may include a dog tag 224 and / or a dog tag reflector 226 . dog tag 224 and reflector 226 may include a metal ( stainless steel , or copper with stainless steel plating ) and have pressure stamped and etched wordings , such as , the name of a company , etc . or symbols , such a company logo . reflector 226 may be silk - screened with graphics including but not limited to the company logo , etc . reflector 226 maybe included in combination with any restraining device as described herein . referring to fig1 , reflective restraining devices 300 , such as collars , leashes to be used on animals , humans , etc . includes nylon and / or polyester material belts 301 decorated with reflective inks in accordance with the present invention . ink 302 is stamped or silk - screened onto belt 301 . ink 302 , which may include highly reflective ink available commercially from 3m ™ or other suppliers , is applied to desired fabrics by a cylindrical roller and pressure stamping process . these inks include materials visible up to 700 ft when hit with a beam of light . referring to fig1 and 13 , a closure unit 400 preferably includes a soft durometer ( 40 - 60 ) rotational molded unit that has a clean cut or slit 402 across about ⅓ of the bottom or back . when the unit is squeezed , the pressure opens the cut allowing the consumer to store change , coins or other small essentials inside unit . the leashes of the present invention may include unit 400 attached to the leash to provide a storage area . the illustrative embodiment of fig1 and 20 show a fire hydrant , but any shaped closure may be employed . referring to fig1 , light - up restraining devices 500 or accessories such as collars or leashes to be used on animals or humans are shown . although fig1 shows leash 500 only with simple reflective embroidered stars , it should be noted that outer surface of leash / collar may be decorated with numerous materials to create graphics for added aesthetics and reflectivity ( including but not limited to silk screen glow - in - the - dark material , reflective pvc , embroidered with reflective threads etc .). a power source / control unit 502 is provided to activate light emitting diodes 504 in leash / collar 500 . in one embodiment , 0 . 5 mm thick fiber optic strands are passed through material of leash to create patterns , graphics or words . fibers 506 permit each star 508 to light up . the fiber is then stitched into place on the back of the material of leash 500 . the leash material may include nylon , polyester etc ., an additional sheet of leash material is placed over the exposed fibers , and the edges are permanently stitched closed . control unit 502 is preferably made of injection molded abs or other durable housing material and is permanently secured to the leash / collar etc . a metal clasp 218 and a buckle ( not shown ), “ d ” ring ( dog snap ) 222 , and grommeted buckle holes ( not shown ) are provided . as is known in the art , these features are provided on all leashes / collars . referring to fig1 , a schematic diagram is shown for a control unit 502 in accordance with the present invention . a programmed chip 512 permits the consumer to control fiber lights to blink on / off at different time intervals or sequences , e . g ., 0 . 5 sec intervals lighting the fiber optic throughout the length of the collar / leash or other designed unit . an on / off switch 501 is also provided to power control unit 502 and its functions by turning a power source 516 on or off . the bundle of fibers are then inserted into control unit 502 , which houses batteries 516 , a printed circuit board ( pcb ) 518 , integrated circuit 512 for driving the leds , and super bright leds 520 for illuminating the bundle of fibers 506 . control unit 502 may also include a flashlight 528 . flashlight 528 remains attached to collar / leash and provides visibility , for example , from up to 750 feet away . control unit 502 may include multiple leds for different bundles of fibers ( see also , e . g ., fig1 ). chip 512 permits the consumer to turn on the flashlight 528 alone or simultaneously with the other led &# 39 ; s , which can blink on / off , for example , in intervals , lighting the fiber optic through the length of the collar / leash or other designed unit . this and other functions may be provided by employing a switch 507 in an alternate embodiment , control unit 502 may include an am / fm radio 580 or other electronic device . radio 580 may be included instead of or in addition to blinking lights , flashlight and / or leds . radio or device 580 may be included on any leash of the present disclosure or as an accessory to conventional leashes and collars . radio 580 and light / leds may be selected individually or used together . referring to fig1 and 17 , radio 508 is shown on a leash 500 . radio 508 may include a bone shaped housing , although any other suitable shapes are also contemplated . radio 508 includes controls 511 , which may include a tuner / scanner , volume control and off and on switches . radio 508 includes an “ on ” light 513 and a speaker 514 . the controls 511 preferably include a low profile to prevent unintended activation of controls . additional entertainment and / or health features may be applied to any or all of the leashes / collars described herein . for added value and interactivity between pet and owner , the following devices may be incorporated into control unit 502 , including but not limited to am / fm radio , digital fm , mp3 player , pedometer , cell phone , personal digital assistant ( pda ), calorie meter , etc . referring to fig1 , an alternate embodiment of restraining device ( e . g ., leash , collar , strap , harness belt , etc .) 500 is shown . it should be noted that the outer surface of leash / collar 600 may be decorated with graphics for added aesthetics and reflectivity , e . g ., silk screen glow in dark material , embroidered with reflective threads , etc . leash 600 includes a control unit 502 , which provides light to one or more clear extruded tubes 602 of pvc or equivalent materials , which are attached to edges of the collar / leash 600 . multi - strands of optical fibers 604 are inserted into tubes 602 . in one embodiment , different styles of fiber optics maybe used and cut in lengths increasing by approximately , e . g ., 2 ″ so that when placed inside tubes 602 , many lights will appear down the length of each tube 602 . in one embodiment , a notched style fiber may be employed . notched style fiber may be , for example , approximately 1 mm in diameter . the notched fiber includes notches 603 on an angle down the length of the fiber . this permits the light in the fiber to refract from the numerous angled cuts as well as from the tip of the fiber . referring to fig1 , another embodiment of the present invention includes a blinking lights leash / collar 700 . one or more bright led &# 39 ; s 702 are placed throughout leash / collar 700 and controlled through a control unit 502 . led &# 39 ; s are exposed throughout the material of leash / collar and may be surrounded by a metal finishing grommet . chip 512 in control unit 502 ( fig2 ) allows a user to control the blinking sequence of the leds e . g ., fast blink on / off 0 . 5 sec , slow blink on / off 1 sec , chasing sequence , etc . leds 702 are visible up to mile . control unit 512 for the embodiment of the present invention , which employs leds , powers leds 702 by including conductive wires to power leds 702 instead of optical fibers 506 . leds 702 are lit in the same way as leds 520 . having described preferred embodiments for pet or human accessories ( which are intended to be illustrative and not limiting ), it is noted that modifications and variations can be made by persons skilled in the art in light of the above teachings . it is therefore to be understood that changes maybe made in the particular embodiments of the invention disclosed which are within the scope and spirit of the invention as outlined by the appended claims . having thus described the invention with the details and particularity required by the patent laws , what is claimed and desired protected by letters patent is set forth in the appended claims .

US-17840202-A

continuous wound - closure techniques use one - way suture . the one - way suture has tissue - grasping surface features which allow passage of the suture in one direction through tissue , but not in the opposite direction . in closing a wound , the one - way suture is passed alternately through tissue on opposed sides of the wound . the wound - closure techniques allow approximation of the sides of the wound without knots , avoid loop stitching and reduce scarring .

as used herein , the term wound means a surgical incision , cut , laceration , severed tissue or accidental wound in human skin or other bodily tissue , or other condition where suturing , stapling , or the use of another tissue connecting device might be required . as used herein , the term tissue includes tissues such as skin , bone , muscle , organs , and other soft tissue such as tendons , ligaments and muscle . certain other terminology is used herein for convenience only and is not to be taken as a limitation on the invention . for example , words such as “ upper ,” “ lower ,” “ left ,” “ right ,” “ horizontal ,” “ vertical ,” “ upward ,” and “ downward ” merely describe the configuration shown in the figures . it is understood that the components may be oriented in any direction and the terminology , therefore , should be understood as encompassing such variations unless specified otherwise . referring now to the drawings , wherein like reference numerals designate corresponding or similar elements throughout the several views , there is shown in fig1 and 2 a suture for use according to the present invention and generally designated at 40 . the suture 40 includes an elongated body 42 having a plurality of barbs 44 disposed along the length of the body 42 . first and second ends 46 , 48 of the body 42 terminate in points 50 , 52 for penetrating tissue . the body 42 of the suture 40 is , in one embodiment , circular in cross section . suitable diameters for the body 42 of the suture 40 range from about 0 . 001 mm to about 1 . 0 mm . the body 42 of the suture 40 could also have a non - circular cross - sectional shape which would increase the surface area of the body 42 and facilitate the formation of multiple barbs 44 . the length of the suture 40 can vary depending on several factors such as the extent of the wound to be closed , the type of tissue to be joined , the location of the wound , and the like . a suture 40 of proper length is selected for achieving suitable results in a particular application . material for the body 42 of the suture 40 is available in a wide variety of monofilament suture material . the particular suture material chosen depends on the strength and flexibility requirements . in one embodiment , the material for the body 42 is flexible and substantially nonresilient so that the shape of an inserted suture 40 will be determined by the path of insertion and the surrounding tissue . in some applications , however , it may be desirable for at least a portion of the body 42 to have sufficient dimensional stability to assume a substantially rigid configuration during use and sufficient resiliency to return to a predetermined position after deflection therefrom . the portions of the ends 46 , 48 of the suture 40 adjacent the points 50 , 52 may be formed of a material sufficiently stiff to enable the points 50 , 52 to penetrate tissue in which the suture 40 is used when a substantially axial force is applied to the body 42 . variations in surface texture of the body 42 of the suture 40 can impart different interaction characteristics with tissues . the body 42 can be formed of a bioabsorbable material which allows the suture 40 to be absorbed over time into the tissue as the wound heals . bioabsorbable material is particularly useful in arthroscopic surgery and methods of suturing . many compositions useful as bioabsorbable materials can be used to make the body 42 of the suture 40 for use in the methods of the present invention . generally , bioabsorbable materials are thermoplastic polymers . selection of the particular material is determined by the desired absorption or degradation time period which depends upon the anticipated healing time for the subject of the procedure . biodegradable polymers and co - polymers range in degradation time from about one month to over twenty - four months . they include , but are not limited to , polydioxanone , polylactide , polyglycolide , polycaprolactone , and copolymers thereof . other copolymers with trimethylene carbonate can also be used . examples are pds ii ( polydioxanone ), maxon ( copolymer of 67 % glycolide and 33 % trimethylene carbonate ), and monocryl ( copolymer of 75 % glycolide and 25 % caprolactone ). germicides can also be incorporated into the body 42 of the suture 40 which are retained by the suture 40 to provide long lasting germicidal properties . the body 42 of the suture 40 can also be formed from non - absorbable material such as nylon , polyethylene terephthalate ( polyester ), polypropylene , and expanded polytetrafluoroethylene ( eptfe ). alternatively , the suture body 42 can also be formed of metal ( e . g . steel ), metal alloys , plastic , or the like . the plurality of barbs 44 is axially - spaced along the body 42 of the suture 40 . the barbs 44 are oriented in one direction facing toward the first end 46 of the suture 40 for a first portion 54 of the length of the suture and in an opposite direction facing the second end 48 of the suture 40 for a second portion 56 of the suture . the barbs 44 are yieldable toward the body 42 . the barbs 44 on each portion 54 , 56 of the suture are oriented so as to allow movement of the suture 40 through the tissue in one direction along with the corresponding end 46 , 48 of the suture 40 . the barbs 44 are generally rigid in an opposite direction to prevent the suture 40 from moving in the tissue in the opposite direction . the barbs 44 can be arranged in any suitable pattern , for example , in a helical pattern as shown in fig1 and 2 . the number , configuration , spacing and surface area of the barbs 44 can vary depending upon the tissue in which the suture 40 is used , and depending on the composition and geometry of the suture body . the proportions of the barbs 44 may remain relatively constant while the overall length of the barbs 44 and the spacing of the barbs 44 are determined by the tissue being connected . for example , if the suture 40 is intended to be used to connect the edges of a wound in skin or tendon , the barbs 44 can be made relatively short and more rigid to facilitate entry into this rather firm tissue . if the suture 40 is intended for use in fatty tissue , which is relatively soft , the barbs 44 can be made longer and spaced farther apart to increase the holding ability in the soft tissue . moreover , the ratio of the number of barbs 44 on the first portion 54 of the suture 40 to the number of barbs 44 on the second portion 56 , and the lengths of each portion 54 , 56 , can vary depending on the application and needs . the surface area of the barbs 44 can also vary . for example , fuller - tipped barbs 44 can be made of varying sizes designed for specific surgical applications . for joining fat and relatively soft tissues , larger barbs 44 are desired , whereas smaller barbs 44 are more suited for collagen - dense tissues . there are also situations where a combination of large and small barbs 44 within the same structure will be beneficial such as when a suture 40 is used in tissue repair with differing layer structures . use of the combination of large and small barbs 44 with the same suture 40 wherein barb 44 sizes are customized for each tissue layer will ensure maximum anchoring properties . the barbs 44 may be formed on the surface of the body 42 according to any suitable method , including cutting , molding , and the like . the preferred method is cutting with acute angular cuts directly into the suture body 42 with cut portions pushed outwardly and separated from the body 42 of the suture 40 . the depth of the barbs 44 formed in the suture body 42 depends on the diameter of the suture material and the depth of cut . a particularly suitable device for cutting a plurality of axially spaced barbs 44 on the exterior of suture filaments utilizes a cutting bed , a cutting bed vise , a cutting template , and a blade assembly to perform the cutting . when operated , the cutting device has the ability to produce a plurality of axially spaced barbs 44 in the same or random configuration and at different angles in relation to each other . various other suitable methods of cutting the barbs 44 have been proposed including the use of a laser . the barbs 44 could also be cut manually . however , manually cutting the barbs 44 is labor intensive , decreases consistency , and is not cost effective . the suture 40 could also be formed by injection molding , extrusion , stamping and the like . the suture 40 can be packaged in any number of desired pre - cut lengths and in pre - shaped curves . the ends 46 , 48 of the suture 40 may be straight ( fig1 ) or curved ( fig2 ). in one embodiment , the ends 46 , 48 of the suture 40 may be surgical needles secured at each end of the body 42 of the suture 40 so that the body 42 extends between the shank ends of the two needles . the needles are preferably constructed of stainless steel or other surgical grade metal alloy . the needles may be secured to the suture body 42 by means of adhesives , crimping , swaging , or the like , or the joint may be formed by heat shrinkable tubing . a detachable connection may also be employed such that the needles may be removed from the body 42 of the suture 40 by a sharp tug or pull or by cutting . the length of the needles is selected to serve the type of tissue being repaired so that the needles can be completely removed leaving the suture body 42 in the desired position within the tissue . barbed sutures suitable for use according to the methods of the present invention are described in u . s . pat . no . 5 , 342 , 376 , entitled inserting device for a barbed tissue connector , u . s . pat . no . 6 , 241 , 747 , entitled barbed bodily tissue connector , and u . s . pat . no . 5 , 931 , 855 . the contents of u . s . pat . nos . 5 , 342 , 376 , 6 , 241 , 747 , and 5 , 931 , 855 are hereby incorporated by reference . according to the present invention , a surgical procedure using barbed sutures 40 is provided for binding together living tissue for healing and regrowth or reconfiguration in vivo . in general , when the suture 40 is used in tissue to repair a wound , the suture is passed through tissue at each of the sides of the wound . the point 50 at one end 46 of the suture 40 is inserted into a first side of a wound such that the point 50 pierces the tissue and the barbs 44 on the end portion 54 of the suture 40 corresponding to the one end 46 yield toward the body 42 to facilitate movement of the suture 40 through the tissue in the direction of insertion . the other end 48 of the suture 40 is also inserted into a side of the wound and advanced through the tissue in like manner . the sides or faces of the wound are then moved together along the suture portions 54 , 56 within the tissue to close the wound . the barbs 44 of the suture 40 grasp the surrounding tissue on each side of the wound and maintains the edges of the wound in position during healing . the leading ends 46 , 48 of the suture 40 protruding from the tissue are then cut and discarded . in one embodiment , ends of the suture 40 in the tissue are made to lie below the surface of the skin by first depressing the skin immediately around the ends and severing the suture body 42 closely against the skin . the skin will rise to cover the ends of the suture 40 . fig3 - 6 show a section of tissue including a portion of a patient &# 39 ; s skin 58 and subcutaneous tissue defining a wound 60 from the surface of the skin 58 down into the tissue . it is understood that the wound 60 in the tissue can be of any configuration and from any anatomical part or organ of the body . accordingly , depending on the configuration of the wound , the wound may comprise several sides and faces . however , the wounds depicted in the figures are straight incisions in the skin 58 to reduce the complexity of the description of the method of the present invention . it is understood that the applicants do not intend to limit the method of the present invention to the closure of only straight incisions . in this embodiment of the method of the present invention , the user , such as a surgeon , selects a suture 40 of sufficient length and having straight ends 46 , 48 . as noted above , in one embodiment , the ends 46 , 48 may be surgical needles . referring to fig3 , the surgeon inserts the needle 46 at the end of the first portion 54 of the suture 40 into the tissue at a point 62 on a first side 64 of the wound 60 and laterally spaced from the face 66 of the wound 60 at the first side 64 . the surgeon advances the needle 46 along a selected substantially straight path through the tissue to extend out of the tissue at a subcutaneous point ( not shown ) in the first face 66 of the wound 60 and subcutaneously penetrating a point ( not shown ) in a face 68 of a second side 70 of the wound 60 . the surgeon continues to advance the needle 46 through the tissue until the point 50 of the needle emerges from the tissue at a distal end of the selected path at an exit point 72 on the second side 70 of the wound 60 . the exit point is laterally spaced from the face 68 of the second side 70 of the wound and longitudinally spaced in a first direction from the point of insertion 62 at the first side 64 of the wound 60 . the surgeon grips the exposed portion of the needle 46 and pulls the needle 46 out of the tissue . this action draws the first portion 54 of the suture 40 having barbs 44 for resisting movement in the opposite direction through the tissue until the barbs 44 on the second portion 56 engage the surface of the skin 58 at the insertion point 62 preventing further advancement of the suture 40 through the tissue . a length of the first portion 54 of the suture body 42 is thus positioned in the tissue along the selected path . the faces 66 , 68 of the wound 60 are approximated by pushing the adjacent sides 64 , 70 of the tissue together along the first portion 54 of the body 42 of the suture 40 in the tissue . the needle 46 is next inserted into the tissue at the exit point 72 and advanced along a substantially straight path through the tissue to extend out of the tissue at a subcutaneous point 74 in the second face 68 of the wound 60 and subcutaneously penetrating a point 76 in the first face 66 of the wound 60 . the surgeon continues to advance the needle 46 through the tissue until the point end 50 emerges from the tissue at a distal end of the selected path at an exit point 78 on the first side 64 of the wound 60 that is laterally spaced from the first face 66 and longitudinally spaced in the first direction from the point of insertion 72 at the second side 70 of the wound 60 . again the surgeon grips the exposed portion of the needle 46 and pulls the needle 46 out of the tissue , drawing the first portion 54 of the suture 40 through the tissue . the previous steps are repeated with the first portion 54 of the suture 40 by inserting the needle 46 into the exit point 78 on the first side 64 of the wound 60 for advancing longitudinally in the first direction along the wound 60 in a zigzag pattern as shown in fig4 . the number of passes of the needle 46 is chosen in accordance with the size of the wound 60 and the strength required to hold the wound closed . the remaining length of the first portion 54 of the suture 40 protruding from the tissue at a first end 80 of the wound 60 is cut and discarded , leaving the remaining first portion 54 of the suture 40 in the tissue . the faces 66 , 68 of the wound 60 are approximated by pushing the adjacent sides 64 , 70 of the tissue together along the body 42 of the suture 40 in the tissue . it is understood that the step of approximating the sides 64 , 70 of the wound 60 can be performed as the suture 40 is advanced or after the end 80 of the wound 60 is reached . moreover , we do not intend to limit ourselves to the depth of the suture paths shown in the figs . as the depth of the suture paths may be determined by the surgeon or the wound to be closed . further , it is understood that straight ends 46 , 48 of the suture may also produce more curved transitions as determined by the surgeon . the surgeon repeats the steps of this procedure with the second needle 48 on the second portion 56 of the suture ( fig5 ). the initial insertion point 62 of the second needle 48 is at the same initial point of insertion 62 of the first needle 46 at the first side 64 of the wound 60 . the surgeon thus advances the second portion 56 of the suture 40 into the tissue along the wound 60 in a direction toward the other end 82 of the wound 60 using the same zigzag pattern approximating the faces 66 , 68 of the wound 60 . the remaining length of the second portion 56 of the suture 40 protruding from the skin 58 at the end 82 of the wound 60 is then cut and discarded ( fig6 ). an embodiment of the method for joining the sides of an open wound in tissue according to the present invention using a subcuticular stitch is shown in fig7 - 10 . the tissue shown in the figures includes an epidermis 84 , dermis 86 , fat 88 , fascia 90 and muscle 92 . by penetrating the subcutaneous layers only and not the outer skin 58 layer , a wound 60 can be closed to facilitate healing while minimizing scar tissue . referring to fig7 , the subcuticular stitch method of the present invention uses a barbed suture 40 including curved ends 46 , 48 . the surgeon begins by inserting the first needle 46 into the tissue below the skin 58 surface at a face 66 on a first side 64 of the wound 60 at an initial insertion point 63 longitudinally spaced from the ends 80 , 82 of the wound 60 . the surgeon advances the needle 46 through the tissue along a curvilinear path until the point 50 of the needle 46 extends from the tissue at a subcutaneous exit point 73 in the first face 66 of the wound 60 longitudinally spaced toward one end 80 of the wound from the entry point 63 of the needle 46 . the surgeon grips the needle 46 and pulls the needle 46 out of the tissue , drawing the first portion 54 of the suture 40 through the tissue until the barbs 44 on the second portion 56 engage the tissue at the insertion point 63 preventing further advancement of the suture 40 through the tissue . a length of the first portion 54 of the suture body 42 is thus positioned in the tissue along the selected curvilinear path as seen in fig7 . turning to fig8 , the surgeon then inserts the needle 46 into the tissue at a subcutaneous entry point ( not shown ) in the face 68 at the second side 70 of the wound 60 . the surgeon repeats the above steps of pushing the needle 46 through the tissue along a selected curvilinear path so that the point 50 of the needle 46 emerges from a subcutaneous exit point ( not shown ) in the second face 68 of the wound 60 longitudinally spaced toward the end 80 of the wound 60 from the entry point . the surgeon grips the needle 46 and draws the first portion 54 of the suture 40 into the tissue further along the wound 60 . in this manner , the surgeon advances the first portion 54 of the suture 40 longitudinally along the wound 60 to the one end 80 of the wound in a wave - like or sinusoidal pattern . as noted above , the faces 66 , 68 of the wound 60 are approximated as the surgeon progresses , or when the end 80 of the wound 60 is reached , by pushing the adjacent sides 64 , 70 of the tissue together along the body 42 of the suture 40 . the needle 46 along with remaining length of the first portion 54 of the suture 40 is drawn through the surface of the skin 58 at the one end 80 of the wound 60 is cut and discarded ( fig8 ). the surgeon repeats the procedure at the other end of the wound ( fig9 ) with the second portion 56 of the suture 40 . the surgeon begins by inserting the second needle 48 into the tissue at a subcutaneous point ( not shown ) in the second face 68 of the wound 60 . the surgeon advances the second needle 48 along a curvilinear path from the point of initial insertion toward the other end 82 of the wound 60 until the needle 48 emerges from a subcutaneous exit point ( not shown ) the second face 68 of the wound 60 longitudinally spaced from the initial entry point of the needle 48 . the surgeon then pulls the needle 48 from the tissue , drawing the second portion 56 of the suture 40 into the tissue , and inserts the needle 48 into the first face 66 of the wound 60 at a subcutaneous entry point ( not shown ) at the first side 64 of the wound 60 . again , the surgeon advances the needle 48 along a curvilinear path until the needle 48 emerges from a subcutaneous exit point 98 in the face 66 further toward the other end 82 of the wound and draws the needle 48 and suture portion 56 through the tissue . fig9 shows the needle 48 being drawn a second time from the second face 68 of the wound 60 . thus , the surgeon advances the second portion 56 of the suture in a sinusoidal pattern to the end 82 of the wound 60 ( fig1 ) and approximates the faces 66 , 68 of the wound 60 . the length of the second portion 56 of the suture body 42 protruding from the skin 58 at the end of the wound 60 is then cut and discarded . fig1 shows a prior art subcutaneous suturing method for closing a wound 60 using a spiraling , corkscrew - shaped stitch pattern . the surgeon begins at one end 80 of the wound by tying a knot 100 in the first loop and advancing the suture in a corkscrew pattern to the other end of the wound 82 where the suture is tied off . tying the knots at the end and burying them , which is preferred by the surgeon , is technically very challenging , even more so when the incision is almost closed . fig1 - 15 show a similar corkscrew - shaped stitch pattern for closing a wound 60 according to an embodiment of the method of the present invention . this embodiment is similar to the method described above using a subcutaneous sinusoidal stitch pattern . referring to fig1 , the surgeon begins by inserting one of the needles 46 into the tissue below the skin 58 surface at a face 66 on a first side 64 of the wound 60 at an initial subcutaneous insertion point 63 longitudinally spaced from the ends 80 , 82 of the wound 60 . the surgeon advances the needle 46 upward through the tissue along a curvilinear path until the point 50 of the needle 46 extends from the tissue at a subcutaneous exit point 73 in the first face 66 of the wound 60 longitudinally spaced toward one end 80 of the wound and above the entry point 63 of the needle 46 . the surgeon then inserts the needle 46 into the tissue at a subcutaneous entry point 102 in the face 68 at the second side 70 of the wound 60 . the surgeon pushes the needle 46 through the tissue along a selected curvilinear path so that the point 50 of the needle 46 emerges from a subcutaneous exit point 104 in the second face 68 of the wound 60 longitudinally spaced toward the end 80 of the wound 60 and below the entry point 102 . the surgeon repeats these steps ( fig1 ) for advancing the first portion 54 of the suture 40 longitudinally along the wound 60 to the one end 80 of the wound in the spiraling , corkscrew stitch pattern . it is understood that the number and diameter of coils can be varied as desired . at any selected convenient point , the surgeon grips the needle 46 for drawing the first portion 54 of the suture 40 through the tissue until the barbs 44 on the second portion 56 engage the tissue at the insertion point 63 preventing further advancement of the suture 40 through the tissue . the surgeon approximates the faces 66 , 68 of the wound 60 as the surgeon progresses or when the end 80 of the wound 60 is reached as described above . the remaining length of the first portion 54 of the suture 40 is drawn through the surface of the skin 58 at the one end 80 of the wound 60 and cut and discarded . the surgeon repeats the procedure at the other end 82 of the wound 60 with the second portion 56 of the suture 40 . as seen in fig1 , several coils of the second portion 56 of the suture 40 have been entered into the tissue in a direction toward the other end 82 of the wound 60 . subcutaneous entry points 106 and exit points 108 in the faces 66 , 68 of the wound 60 are visible . the surgeon advances the second portion 56 of the suture 40 to the end 82 of the wound 60 ( fig1 ) and approximates the faces 66 , 68 of the wound 60 . the length of the second portion 56 of the suture body 42 protruding from the skin 58 at the end of the wound 60 is then cut and discarded . another embodiment of a subcutaneous suturing method for joining and holding closed an open wound 60 in tissue according to the present invention is shown in fig1 - 18 . this method also uses a barbed suture 40 having curved pointed ends 46 , 48 , such as surgical needles . referring to fig1 , the surgeon begins by inserting the first needle 46 subcutaneously into the tissue at a face 66 on a first side 64 of the wound 60 at an initial insertion point 63 adjacent one end 80 of the wound 60 and pushes the needle 46 through the tissue along a selected curvilinear path until the needle 46 extends from the tissue at a subcutaneous exit point 73 in the first face 66 of the wound 60 longitudinally spaced from the end 80 of the wound 60 in a direction toward the other end 82 of the wound 60 . the surgeon grips the needle 46 and pulls the needle 46 out of the tissue for drawing the first portion 54 of the suture 40 including barbs 44 for resisting movement in the opposite direction through the tissue until the barbs 44 of the second portion 56 engage the first face 66 of the wound 60 at the insertion point 63 preventing further advancement of the suture 40 into the tissue . a length of the first portion 54 of the suture body 42 is thus positioned in the tissue along the selected curvilinear path . as further seen in fig1 , the surgeon next inserts the second surgical needle 48 into the tissue at a subcutaneous entry point ( not shown ) in the face 68 at the second side 70 of the wound 60 substantially opposite the initial point of insertion 63 of the first needle 46 at the one end 80 of the wound 60 . the surgeon advances the second needle 48 through the tissue along a selected curvilinear path until the needle 48 extends from the tissue at a subcutaneous exit point ( not shown ) in the second face 68 of the wound 60 . the surgeon then pulls the second needle 48 for drawing the second portion 56 of the suture 40 through the tissue , including barbs 44 for resisting movement in the opposite direction , leaving a length of the second portion 56 of the suture 40 in the tissue at the end 80 of the wound 60 . the surgeon repeats the above steps with the first needle 46 and second needle 48 at the second and first sides 64 , 70 , respectively , of the wound 60 . in this manner , the surgeon advances the suture 40 longitudinally along the wound 60 from the one end 80 of the wound to the other 82 in a shoelace pattern . as seen in fig1 , several passes of the suture 40 have been entered into the tissue of the wound 60 . the faces 66 , 68 of the wound 60 are approximated as the surgeon progresses , or when the end 82 of the wound 60 is reached , by pushing the adjacent sides 64 , 70 of the tissue together along the body 42 of the suture 40 . the lengths of the first portion 54 and second portion 56 of the suture 40 protruding from the skin 58 are cut and discarded ( fig1 ). it is understood that the method of the present invention shown in fig7 - 10 can be used to generate a similar stitch pattern if a second suture is used which is entered in the tissue to mirror the path of the first suture . another embodiment of the method according to the present invention for joining the sides 64 , 70 of tissue in an open wound 60 is shown in fig1 and 20 . in this embodiment , the surgeon inserts a first curved or straight end 46 of the suture 40 , such as a needle , into the tissue at a point 62 on a first side 64 of the wound 60 and laterally spaced from the face 66 of the wound 60 at the first side 64 . the surgeon advances the needle 46 through the tissue along a curvilinear path until the needle 46 emerges from the tissue on a second side 70 of the wound at an exit point 72 laterally spaced from the face 68 of the second side 70 of the wound 60 and longitudinally spaced in a first direction from the point of insertion 62 . this path subcutaneously passes through both faces 66 , 68 of the wound 60 . the surgeon grips the needle 46 and pulls the needle 46 out of the tissue for drawing the first portion 56 of the suture 40 through the tissue until the barbs 44 of the second portion 56 engage the surface of the skin 58 at the insertion point 62 preventing further advancement of the suture 40 into the tissue . the faces 66 , 68 of the wound 60 are approximated by pushing the adjacent sides 64 , 70 of the tissue together along the body 42 of the suture 40 in the tissue . the length of the first portion 54 of the body 42 of the suture 40 protruding from the skin 58 is cut and discarded ( fig1 ). the surgeon then inserts the second needle 48 into the tissue at the point of insertion 62 of the first needle 46 at the first side 64 of the wound 60 . the surgeon pushes the needle 48 through the tissue along a curvilinear path which substantially mirrors the passage of the first needle 46 until the needle 48 emerges from the tissue at an exit point 110 laterally spaced from the wound and longitudinally spaced in a second direction from the point of insertion 62 such that the paths of the first and second portions 54 , 56 of the suture 40 overlap . again , the path of the second needle 48 subcutaneously passes through the faces 66 , 68 of the wound 60 . the surgeon grips the second needle 48 and pulls the needle 48 from the tissue for drawing the second portion 56 of the suture 40 into the tissue . the length of the second portion 56 of the suture 40 protruding from the skin 58 is cut and discarded , leaving a stitch in the tissue which resembles the greek letter alpha ( fig2 ). this stitch has its greatest benefit in small wound and incision closure . the alpha - shaped stitch can be placed quickly in tissue as compared with conventional loop sutures . moreover , this stitch pattern has no blood constricting loops , leaves no stitch marks on the surface of the skin , and does not have to be removed from the patient if bio - absorbable material is used . two or more of the alpha - shaped stitches may be used to close a larger wound . a particular application of the alpha - stitch according to the method of the present invention is as a means of restricting bleeding from an arterial opening by constricting the tissue above and around the arterial opening . for example , the introduction and removal of catheters into the femoral artery is typically required when performing cardiac catheterization , percutaneous interventions , and other vascular procedures . these puncture wounds are typically self - sealing after several hours of sustained external pressure at and around the insertion site of the puncture wound . fig2 and 22 show the alpha - stitch according to a method of the present invention positioned for performing this function . note that the path of the suture portions 54 , 56 is curvilinear with the respect to the skin 58 surface and that the deepest points of the arcs pass immediately above the puncture site 112 in the artery 114 . in this embodiment , the ends 46 , 48 of the suture 40 are pulled to put tension in the tissue . as the ends 46 , 48 of the suture 40 are pulled , the tissue embraced by the suture is pulled both inward from the areas lateral to the artery 114 and downward from areas immediately above the artery 114 . this constriction of tissue increases the density of tissue around the arterial puncture site 112 and imparts forces with vectors directed toward the arteriotomy site to limit bleeding . further , this suture method avoids the need to traverse the artery wall or lumen , thus eliminating the risk of vessel wall dissection and promoting introgenic thrombogenesis . the method of the present invention is also useful in binding together partially or completely severed tendons or other internal tissue repairs requiring considerable tensile strength . for example , referring to fig2 , a finger 120 is shown with a portion of the outer layer of tissue cut - away to schematically show a severed tendon 122 . a kessler suturing method for joining the two ends 124 , 126 of the tendon 122 is shown in fig2 . this method requires the surgeon to apply an intricate stitch pattern and to complete the tendon connection with one or two technically challenging knots 128 . no portion of the suture knot 128 may protrude from the outside surface of the repaired tendon 122 where it could snag the surrounding tendon sheath and impede healing . the knot 128 also presents a particular dilemma since it must be tied between the two ends 124 , 126 of the tendon 122 , where it can be a barrier between tendon sections that must appose in order to effectively heal . a further limitation of the conventional tendon repair method is that relatively small amounts of tension can stretch the tendon 122 , allowing it to slide along the smooth monofilament fiber and effectively disrupt , or in the case of greater amounts of tension , separate completely at the wound margin . this outcome substantially limits healing even though the suture material remains intact . a method according to the present invention for joining the two ends 124 , 126 of the tendon 122 is shown in fig2 - 28 . referring to fig2 , the surgeon begins by inserting the first end 46 of the suture 40 , which may a straight or curved surgical needle , into one end 124 of the tendon 122 and pushing the needle 46 through the tendon 122 along a selected curvilinear path until the point 50 of the needle 46 extends from an exit point 130 in the periphery of the tendon 122 longitudinally spaced from the one end of the tendon 122 . the first needle 46 is gripped and pulled out of the tendon for drawing the first portion 54 of the suture 40 through the tendon 122 leaving a length of the first portion 54 of the suture in the tendon end 124 between the end of the tendon 122 and the exit point 130 . the surgeon reinserts the needle 46 into the periphery of the tendon 122 at an entry point 132 immediately adjacent the exit point 130 and pushes the needle 46 along a selected curvilinear path until the point 50 of the needle 46 exits the other side of the tendon at an exit point 134 that is longitudinally spaced from the entry point 132 . it is understood that the surgeon could use the exit point 130 as the next entry point for the needle 46 if desired . the surgeon pulls the needle 46 out of the tendon for drawing the first portion 54 of the suture 40 through the tendon 122 , reinserts the needle 46 into the side of the tendon 122 at an entry point 136 immediately adjacent the exit point 134 and pushes the needle 46 along a selected curvilinear path back out of the other side of the tendon 122 at an exit point 138 longitudinally spaced from the previous entry point 136 . it is understood that the surgeon makes as many passes as deemed necessary for holding the end 124 of the tendon 122 , or as the length or thickness of the tendon 122 allows , and removes the remaining length of the first portion 54 of the suture 40 . as seen in fig2 , these steps are repeated with the second portion 56 of the suture 40 at the other end 126 of the tendon 122 . the pattern of the second portion 56 of the suture 40 in the second end 126 of the tendon 122 generally mirrors the first portion 54 of the suture 40 in the first end 124 of the tendon 122 , including exit points 130 a , 134 a , 138 a and entry points 132 a , 136 a . the ends 124 , 126 of the tendon 122 are brought together while maintaining tension on the free ends of the sutures . referring now to fig2 , a second suture 40 a is introduced at the second end 126 of the tendon 122 . the first needle 46 a of the second suture 40 a is inserted into the end 126 of the tendon 122 and pushed through the tendon 122 along a selected curvilinear path until the needle 46 a extends from an exit point 140 in the periphery of the tendon 122 substantially opposite the first exit point 130 a of the second portion 56 of the first suture 40 . the needle 46 a of the second suture 40 a is pulled out of the tendon 122 for drawing the first portion 54 a of the second suture 40 a through the tendon 122 leaving a length of the suture 40 a in the tendon 122 between the end 126 of the tendon 122 and the exit point 140 . the surgeon repeats the steps . described above by reinserting the needle 46 a into the tendon 122 at an entry point 142 ( fig2 ) adjacent the exit point 140 and pushing the needle 46 a along a selected curvilinear path until the needle 46 a emerges from an exit point 144 in the periphery of the tendon 122 substantially opposite the second exit point 134 a of the second portion 56 of the first suture 40 . in this manner , the surgeon advances longitudinally along the end 126 of the tendon 122 entering at 146 and exiting at 148 . the previous steps are repeated at the other end 124 of the tendon 122 with the second portion 56 a of the second suture 40 a . the number of sutures used depends on the size , caliber , and length of the tendon to be repaired . big tendons will require more than two sutures whereas one may suffice for very small tendons . tendon repair with two sutures according to the present invention exhibits equivalent or better holding power as the prior art technique . moreover , tendons repaired according to the methods of the present invention maintain their original configuration , profile , contour , and form better when being stretched . the method of the present invention may be embodied in many surgical procedures . the procedures include both open surgery as well as endoscopic and laparoscopic surgery . further , the uses of embodiments of the present invention may include repair of wounds , fastening of tissue junctions formed by the procedures , and positioning of tissue . the surgical procedures described herein are known to those of ordinary skill in the art , and accordingly are described only to a level of detail required to convey the respective embodiments of the method of the present invention . in fig2 - 48 , where various steps of insertion are omitted from a drawing , it should be understood that the description and accompanying text of fig1 - 28 apply to inserting the sutures 40 . fig2 shows a stomach 200 prior to performance of a nissen fundoplication . this procedure is performed on patients who suffer from gastroesophageal reflux disease and do not respond to medical treatment . as shown , the first portions 54 of two respective barbed sutures 40 are inserted into a proximal location of the fundus 202 and into the serosal and muscularis layers , and the respective second portions 56 remain free . the stomach &# 39 ; s fundus 202 is pulled behind and wrapped 206 around the esophagus 204 . the respective second portions 56 are then advanced similarly into the apposing part 208 of the stomach 200 , as shown in fig3 . the same result in fastening may be achieved by performing the procedure in a different order . the fundus 202 may be pulled and wrapped 206 behind the esophagus 204 first , and then temporarily clamped or stapled in placed while the first and second portions 54 , 56 are inserted in the configuration shown in fig3 . other sequences may also be used and remain within the scope of the present invention . the barbed suture 40 may also be inserted as shown in fig3 , in either a sinusoidal or coiled configuration as previously described . the curved insertion is performed subsequent to pulling and wrapping 206 the fundus 202 behind the esophagus 204 , and then clamping or stapling in place . fig3 shows a laparoscopic insertion device 220 used to stabilize a bowel structure 222 in position in advance of performing an anastomosis , whereby an end - to - end surgical connection of hollow organs is conventionally performed . the laparoscopic insertion device 220 comprises a tubular body in which the barbed suture 50 is disposed , with holes at the leading and trailing ends , similar to that disclosed in u . s . pat . no . 5 , 342 , 376 to ruff , the contents of which were previously incorporated by reference herein . the insertion device 220 penetrates using the point 50 of the suture to pierce the epidermis 84 , dermis 86 , fat 88 , fascia 90 , muscle 92 , and the peritoneum 94 before passing into the abdominal cavity 224 . the insertion device 220 then passes into the bowel structure 222 . a laparoscopic grasping tool 226 is shown to be holding the bowel structure in position until the suture is in place . it should be noted that the bowel structure 222 may also be stabilized by placement of a barbed suture 40 from the inside of the structure 222 . in fig3 , the laparoscopic insertion device is removed by pulling it outward 228 , exposing the suture 40 , while the pointed end 50 of the suture 40 is retained by its barbs against the removal force of the insertion device 220 . the suture 40 is in place in fig3 . when the procedure that gave rise to the need to tie the bowel structure 222 in place is complete , the suture may be cut at an exposed point 229 . as shown , the trailing end of the suture 40 extends through the epidermis 84 at the point of initial insertion , and the suture 40 may be cut at point 229 to allow that portion of the suture 40 to be removed by pulling on the trailing end . optionally , the barbed suture pointed end 50 may continue through the bowel structure 222 tissue , into the abdominal cavity 224 , and through any number of desired selected layers of the peritoneum 94 , muscle 92 , fascia 90 , fat 88 , dermis 86 , and epidermis 84 . if the suture 40 passes through the epidermis 84 and is to be left in place , the suture 40 may be cut off such that the end of the suture 40 resides beneath the epidermis 84 . alternatively , in a method similar to that described for fig3 , when the procedure that gave rise to the need to tie the bowel structure 222 in place is complete , the suture 40 may be cut at the exposed point 229 and in addition at another exposed point along the suture 40 on the opposite side of the bowel structure 222 , allowing removal of both ends of the suture 40 . a portion of the biliary system is shown in fig3 . the liver 230 is shown in partial section view , and the gallbladder 232 , bowel 234 , and stomach 200 are the other organs that are shown . the barbed suture of the present invention may be used to perform a rodney smith procedure with roux - en - y for the anastomosis of the bowel 234 to the liver 230 . in such an operation , the bile duct 236 may be cut , for example , at point 237 and anastomized to the bowel 234 at an incision in the bowel 234 at point 238 . the sutures 40 may be inserted as shown in fig3 with either an insertion device or with needles as previously discussed . the remaining portion of the bile duct 239 is removed and the wound at the end where it connects to the bowel 234 is sutured closed , which may also be done with sutures 40 of the present invention . in addition , barbed sutures can be placed in a curvilinear path , as shown in fig3 by proceeding with the suture around the bile duct 236 and the opening in the bowel . the first insertion point of the suture may be either in the bowel or the bile duct . the appendix 240 is being removed from the cecum 242 of the large intestine in fig3 . prior to cutting of the appendix 240 , the suture 40 must be placed so that it will be ready to tie off the appendiceal stump 244 . the suture 40 may be placed using a curved insertion device ( not shown ), or with curved needles 46 , 48 . the barbed suture 40 is placed around the base of the appendix 240 by inserting the first end of the first portion of the suture at an insertion point 62 ( fig3 ) and pushing the first portion 54 in one direction through the muscularis and serosal layers of the cecum 242 around the base for at least one half of the circumference . then the second portion 56 is likewise placed by inserting at the insertion point 62 and pushing the second portion 56 in the other direction through the muscularis and serosal layers of the cecum 242 around the base for at least until the second portion 56 crosses the first portion 54 . the appendix 240 is then removed , and the stump 244 is inverted while the suture 40 is pulled taut , similar to a purse - string as well as the alpha stitch shown in fig1 - 22 . although fig3 shows both needles 50 , 52 and respective suture end portions 54 , 56 extending from the cecum 242 , having both end portions 54 , 56 extend from the cecum 242 is optional . with the use of an insertion device of the nature of that shown in fig3 , for example ( device 220 ), one end may be left embedded in the cecum 242 and the other end may be pulled to invert the appendiceal stump 244 with the purse - string or alpha stitch . fig4 - 42 show three stages of the procedure for a zenker &# 39 ; s diverticulectomy . a zenker &# 39 ; s diverticulum 260 is a sac that protrudes from the esophagus 262 below the pharynx 264 . the diverticulum 260 is the herniation of the mucdsal sac between the fibers of the pharyngeal constrictor muscle and the cricopharyngeal muscle 266 . the diverticulum forms an orifice 268 to the lumen 270 of the esophagus 262 , and is shown in its initial untreated position in fig4 . in fig4 the diverticulum 260 is inverted and pulled into the esophagus 262 through the orifice 268 using an endoscopic grasping tool 272 . an endoscopic insertion device 274 , similar to the laparoscopic insertion device 220 of fig3 - 34 , is used as shown in fig4 to insert the barbed suture 40 into the cricopharyngeal muscle 266 above the orifice 268 , exiting at the orifice , and then again penetrating the muscle 266 . the muscle 266 on both sides of the orifice 268 is approximated to close the orifice . the diverticulum 260 is then endoscopically cut and removed ( not shown ). alternatively , the stitch used to close the orifice 268 may be a purse - string type or alpha type , as shown in fig3 and 39 . multiple sutures may be used to close the orifice . further , the procedure of suturing closed the orifice may be performed in a similar manner without inverting the diverticulum 260 into the esophagus 262 . in this alternative the diverticulum remains outside the esophagus 262 and is not excised . the viscus structure 300 shown in fig4 - 44 has an ulcerative lesion 302 on its inside wall 304 . an endoscopic camera 306 ( scope ) allows the procedure to be performed , and an endoscopic insertion device ( not shown ) in a separate tube within the scope inserts the sutures 40 as previously described . the scope 306 may approach the lesion 302 through the anus or the oropharynx . the tissue on each side of the lesion 302 is approximated and the endoscopic devices are removed as shown in fig4 . fig4 and 46 respectively show a closure of a cystostomy incision in a urinary bladder 320 . the closure is shown as having a curvilinear path , and may be inserted in such a curvilinear path similarly to the sinusoidal method ( fig4 ) or coil method ( fig4 ) previously discussed and shown by fig7 - 10 and fig1 - 15 , respectively , although other methods discussed herein may also be used . the suture 40 passes through the muscularis layer of the bladder in a bidirectional fashion . a replacement heart valve 340 is shown in fig4 . the annular cuff 342 of the heart valve 340 forms the periphery of the valve . the cuff 342 is joined to fibrous heart tissue 344 that forms a ring in the location where the valve 340 is placed . two sutures 40 a , 40 b are shown , respectively having first portions 54 a and 54 b that pass through the cuff 342 and tissue 344 in one direction and second portions 56 a and 56 b that proceed in the other direction . threading of the sutures 40 a , 40 b is performed similarly to the sinusoidal and coil methods previously discussed , and may start from either the cuff 342 or the tissue 344 . various configurations may be used to install the valve 340 in accordance with the knowledge of one of ordinary skill in the art , such as only one suture for the full periphery of the valve , or multiple sutures that each include a portion of the valve &# 39 ; s periphery , and providing redundancy of sutures as appropriate . the replacement heart valve may be a bioprosthetic valve or an artificial prosthetic mechanical valve . in addition , this method may be used on any foreign element that has a periphery and requires attachment to tissue , for example , a patch for closing a septal defect in the , heart . the method according to the present invention may also be used to secure devices to tissue , both inside and outside of a body . a central line device 360 , as used for intravenous access , is shown in fig4 , and is attached to a person &# 39 ; s leg 362 . examples of other devices that are required to be secured include catheters and monitors ; tumor monitors in particular are an example of an internal device that may benefit from the method of the present invention . eyelets 364 a , 364 b are provided on the device 360 and the suture 40 passes through each eyelet 364 a , 364 b before penetrating and passing through tissue of the leg 362 in a manner similar to that previously described , and being pulled snug to secure the device 360 . to facilitate removal of the barbed suture 40 , the suture 40 may be cut at a point within the central portion 366 , separating the portions of the suture 40 with opposing barbs . then the separate sections 54 , 56 of the suture 40 may be removed by pulling on an exposed portion in the direction that the barbs allow movement of the suture 40 through the tissue . this method of removal is not limited to the use shown in fig4 , but may apply to any use of the barbed suture . the barbed sutures of the present invention may also be used in a variety of cosmetic surgery applications . such applications include but are not limited to facelifts , browlifts , breast lifts , and thigh lifts . in each of the procedures , once the sutures are in place and as tension is maintained on the free ends of the suture ( not shown in the figures referenced below ), the engaged tissues are manually grouped and advanced toward the insertion point to achieve the desired lifting effect . the tissue into which the sutures are inserted are soft tissue , meaning any tissue that is not an organ or a vessel . multiple sutures may be used for further augmentation or maintenance of lift . a facelift and two methods of browlifts are shown in fig4 . one end 380 of a barbed suture 382 is inserted using a needle ( not shown ) at the temporal hairline at point 384 and advanced through the subepidermal tissue underneath the scalp , exiting distally . subepidermal tissue comprises the papillary dermis , reticular dermis , subcutaneous tissue , or any combination thereof . the other end 386 is inserted at the same location and extended towards the nasolabial fold 388 , engaging the subepidermal tissue , the superficial muscular aponeurotic system , or both , and exiting distally . as tension is maintained on the free ends ( not shown ) of the suture 382 , the engaged tissues on the lower end 386 are manually grouped and advanced toward the insertion point 384 to achieve the desired lifting effect . the procedure is repeated on the opposite side of the face . similar procedures may be performed to provide the lifts made in other locations with barbed sutures 390 , 400 . in addition , the barbed sutures may be applied with the use of an insertion device as previously discussed . for example , the barbed sutures 382 , 390 shown in fig4 may be put in place using an insertion device from either end of the respective suture . one method of performing a browlift is shown with one end 408 of a barbed suture 410 being inserted at point 412 at the hairline ( for nonreceding hairlines , as depicted ) or at the midpoint between the hairline and the eyebrow ( for receding hairlines , not shown ). this end 408 is advanced through the subepidermal tissue towards and on through the scalp . the other end 414 is inserted at the same point and advanced through the subepidermal tissue in the opposite direction , exiting at the inferior aspect 416 of the brow . the procedure is repeated on the opposite side of the forehead , but for convenience herein a different method is shown in the same figure . once again , the suture 410 may be put in place with the use of an insertion device from either end . a second method of performing a browlift is shown in fig4 with one end 420 of a barbed suture 422 being inserted at point 424 at the hairline ( for nonreceding hairlines , as depicted ) or between the hairline and the eyebrow ( for receding hairlines , not shown ). this end 420 is advanced through the subepidermal tissue , exiting at the inferior aspect 426 of the brow . the other end 428 is inserted at the same point and is also advanced through the subepidermal tissue , but at a slight angle to the path taken by the first end 420 and also exiting at the inferior aspect 426 of the brow . this results in the approximate inverted vee - shaped configuration shown . the procedure may be repeated across the forehead . barbed sutures of the present invention may similarly be used as a tissue - sculpting device to perform a thigh or breast lifting procedure . these procedures are similar to those shown for the facelift and browlift of fig4 , and accordingly no additional drawings are required but respective descriptions are as follows . to perform a thigh lift , multiple sutures are inserted by needle at the inguinal crease , spaced approximately 0 . 5 - 1 . 5 cm apart , beginning at the lateral aspect of the pubic triangle and extending medially approximately 180 degrees to the vicinity of the gluteal fold . the suture is advanced approximately 8 cm cranially through the subepidermal tissue . the opposite end of the suture is inserted in the same location and similarly advanced approximately 8 cm caudally . after exiting through the skin distally at each end , tension is maintained on the free ends of the suture , and the engaged tissues are manually grouped and advanced toward the insertion point to achieve the desired lifting effect . the process is repeated with multiple sutures around the semi - circumference of the thigh , and then repeated on the opposite thigh . to perform a breast lift using a barbed suture of the present invention , one end of the barbed suture is inserted by needle into the skin at the upper aspect of the breast curvature . the needle is advanced such that the medial barbs engage the subcutaneous and dermal tissues , while the distal barbs engage the pectoralis muscle ( and where possible , the periosteum of the clavicle ), and then exit distally through the skin . the other end of the suture is inserted at the same point by needle , and advanced caudally through the fibrous and fatty tissues of the breast exiting at various points along the lower curvature of the breast . additional sutures are similarly inserted at a variety of appropriately spaced locations along the breast . as tension is maintained on the free suture ends , the breast is lifted along the axis of the suture , with the barbs locking the lift into place . lifting is continued until the desired effect is achieved . results from such a procedure may benefit from the use of a barbed suture with longer barbs than may be necessary in other procedures , in order to grasp fatty breast tissue effectively . in fig5 , an insertion device 500 is shown in a procedure to close an axial wound in a blood vessel , such as an artery or vein . the wound 112 is similar to that shown in fig2 , but the method is different in that the method of fig2 uses needles and does not penetrate the artery 114 , rather constricting the tissue above and around the arterial opening . the insertion device 500 of fig5 comprises a tubular body in which the barbed suture 50 is disposed . the wound 112 may be a puncture in an artery 114 as occurs as the result of the introduction and removal of catheters , as discussed in the text accompanying fig2 . the sharp pointed end 50 of the suture 40 is pushed with the leading end of the insertion device 500 through the skin 58 and tissue 70 on one side of the artery 114 , through the artery wall on one side of the wound 112 , into the interior 504 of the blood vessel 114 , through the artery wall on the other side of the wound 112 , and into the tissue 64 on the other side of the wound 112 . the trailing end of the insertion device 500 is then pulled on to remove the insertion device 500 , leaving the suture 40 in place . two embodiments of a suture left in place by an insertion device are shown in fig5 and 52 . in fig5 , the portion 506 of the suture 40 in the interior 504 of the artery 114 has barbs . the embodiment of fig5 omits barbs in the interior 504 of the artery 114 , and the barbs are omitted for a portion 508 that extends into the artery 114 wall . the portion 508 without barbs could extend less or more than shown , and into the tissue 70 , 64 , so long as there are no barbs inside the artery 114 . to reduce the chance of clotting of blood on or around the suture , an antithrombotic agent may be applied on the suture . although fig5 - 51 show the suture 40 with the pointed end 50 embedded in tissue 70 , 64 , the suture 40 may also be put into place with the pointed end 50 , or both ends , extending out of the skin 58 , where the end or ends may be cut . a straight incision wound , about 1 . 5 cm deep , was created in each of four samples of cadaveric porcine skin tissue . the tissue samples measured 4 cm by 10 cm . each incision was centered on the skin sample so that the wound was 4 cm long from end to end . each wound was closed according to a different suture method using identical barbed sutures made from monofilament pds ( polydioxanone ) size 0 . one wound was closed according to the method shown in u . s . pat . nos . 5 , 342 , 376 and 6 , 241 , 747 , without using the inserting device ( the ruff method ). seven sutures were placed along the length of the wound and running generally perpendicularly to the faces of the wound . when placed , the sutures dipped below the incision line thus engaging subcutaneous tissue below the incision and the ends of the sutures engaged some dermis . a second wound was closed using seven needle - tipped sutures placed along the length of the wound in the dermis and running generally perpendicularly to the faces of the wound similar to the method shown in u . s . pat . no . 5 , 931 , 855 ( the buncke method ). in both methods , the length of each suture buried under the skin was approximately 6 cm . a third wound was closed using the zigzag stitch pattern in the dermis as described above and shown in fig3 - 6 . the number of passes resulted in four entry / exit points on each side of the wound . a fourth wound was closed using the corkscrew - shaped stitch pattern described above and shown in fig1 - 15 . the number of passes resulted in seven complete loops with the tops of the loops engaged in the dermis . the tissues were held together only by the sutures . biomechanical strength testing was carried out as follows . each sample was positioned so that the surface of the tissue sample was substantially vertical and the incision was generally horizontal . the bottom edge of the sample was immovably secured . the upper edge of the sample was attached to a berkley digital fish scale ( 0 - 50 lb .) the scale was then raised vertically generating tension across the wound . the scale was raised until the tissues totally separated . the peak force required to separate the incision was recorded as the breaking strength . seven incisions were made at various locations on each of three dogs . the length of the incisions ranged from ½ inch to 4 inches and the depth of the incisions from the dermis to the muscular level . the incisions were closed with barbed sutures made from monofilament pds ( polydioxanone ) size 0 and conventional sutures &# 39 ; according to the following scheme with the locations randomized : the dogs were housed for two weeks . daily clinical and necropsy observations were performed on all surgical sites . with the exception that three of six sites closed by nylon sutures had some sutures chewed out by the dog , all incisions healed normally and no dehiscence occurred . the other three sites closed with nylon sutures had a railroad - tile appearance , one site in particular being very pronounced . none of the topical skin sites closed with barbed sutures had such an appearance . this example shows the efficacy of barbed sutures in an in vivo model . the methods of the present invention have a number of advantages , including improving the biomechanical performance of barbed sutures . the curvilinear placement paths of the suture , as contrasted with linear insertion , provide substantially increased strength for holding the edges of a wound together . moreover , the insertion of a single suture with curvilinear techniques replaces the insertion of a plurality of sutures . the new methods provide an efficient means for a surgeon to close a wound , reducing the time necessary to place the suture and the trauma to the patient . surgeons can quickly and easily utilize the suturing methods during any type of surgery to quickly join the edges of a wound in tissue without threading and tying numerous individual stitches . the new suture methods are performed in a manner similar to conventional suturing thus realizing the advantages thereof . the methods minimize damage to tissue when inserted and minimize scarring or tissue necrosis across the wound . the sutures can be placed in the tissue in a manner to control and adjust the tension on the suture or the compression of the tissue . although the present invention has been shown and described in considerable detail with respect to only a few exemplary embodiments thereof , it should be understood by those skilled in the art that we do not intend to limit the invention to the embodiments since various modifications , omissions and additions may be made to the disclosed embodiments without materially departing from the novel teachings and advantages of the invention , particularly in light of the foregoing teachings . for example , the methods of the present invention can be used alone or with other closure methods , such as topical skin adhesives to aid in holding the position of the tissue . accordingly , we intend to cover all such modifications , omission , additions and equivalents as may be included within the spirit and scope of the invention as defined by the following claims .

US-85018610-A

a construction toy formed from a plurality of building blocks . a primary form of building block is formed as a wafer - shaped rectangle having top and bottom surfaces formed of complemental interconnectable arrays of posts or rectangular vanes on a top surface and parallel - walled channels on a bottom surface allowing the blocks to stack and lock top - to - bottom . the sides of the primary building blocks have complemental prominences and orifices or projections and grooves which can connect together allowing the blocks to stack side - to - side . orifices are also located in a portion of the top surface , usable in any way the orifices of the side surfaces are usable . a secondary form of building block is a round wafer - shaped block with beveled gear teeth along a side wall of the block . the secondary block has posts on a top surface and vanes , similar to the primary blocks , and has a hub on a bottom surface . the hub is rotationally receivable within the orifices of the primary blocks . secondary blocks may be attached to primary blocks in an interfacing pattern allowing a user to construct representations of both planar gear pairs and beveled gear pairs . a third form of building block , as does the primary form , among other things , attaches rotationally to the top surface of the secondary block , acting as an input driver for an assembly of secondary blocks .

referring now to the drawings wherein like numerals represent like parts throughout , reference numeral 10 is directed to a mounting block , shown in detail in fig1 through 9 . in essence , the mounting block 10 is substantially a wafer - shaped construct having a top surface 11 , a bottom surface 12 and a plurality of long side surfaces 14 and short side surfaces 15 . the top surface 11 preferably has a plurality of posts 40 or vanes 46 ( shown in fig3 ). the bottom surface 12 has a plurality of channels 50 ( fig7 ). the side surfaces 14 , 15 have either a prominence 70 or an orifice 80 positioned thereon . the posts 40 or vanes 46 are configured to fasten within the channels 50 and the prominences 70 are configured to fasten within the orifices 80 allowing a plurality of mounting blocks 10 to be attached together in a variety of ways , as shown in fig2 and fig2 . more particularly , the mounting block 10 includes a top surface 11 and a bottom surface 12 which respectively define first and second attachment surfaces . these attachment surfaces are complemental , allowing a plurality of mounting blocks 10 to be connected top - to - bottom in a series . the attachment means of the top surface 11 preferably includes a plurality of posts 40 , shown in detail in fig8 configured in rows 42 that radiate outwardly from a center of the top surface 11 . the posts 40 may be configured in other functional patterns as well , such as that shown in fig4 and fig5 . each post 40 is preferably a substantially cylindrical construct fixedly attached on a first flat end 41 to the top surface 11 and extending upwardly perpendicular to the top surface 11 . alternatively , the posts 40 can be square or some other shape in cross - section . each post 40 is of similar size and each row 42 is substantially linear , such that any flat surface placed against side walls 45 of the posts 40 may have a point of tangency with each of the posts 40 in the row 42 . an alternative top surface attachment means , shown in fig3 through 35 replaces the rows 42 of posts 40 with linear vanes 46 of cross - section similar to that of the posts 40 . between the vanes 46 singular posts 40 may be positioned . some of the vanes 46 are of greater height than other vanes 46 . preferably , each post 40 has a toroidal flair 44 circumscribing the side wall 45 near a second flat end 43 , as shown in detail in fig8 . the toroidal flair 44 lies in a plane parallel to the top surface 11 . also on the top surface 11 , linear webbing 90 is formed in a variety of positions beneath the top surface 11 . a top edge of the linear webbing 90 conforms to a plane coextensive with the top surface 11 and defining the exact location of the top surface 11 . the linear webbing 90 provides added structural strength to the mounting blocks 10 , reduces the volume of plastic used in manufacture , shortens the plastic cycle time in molding and helps define the top surface 11 . the attachment means of the bottom surface 12 includes a plurality of channels 50 , shown in detail in fig9 that preferably radiate outwardly from a center of the bottom surface 12 . alternatively , the channels 50 may circumscribe the bottom surface 12 in a concentric pattern , shown in fig4 and fig5 . each of the channels 50 is formed from a pair of parallel walls 52 which are preferably rectangular plates which extend downward orthogonally from said bottom surface 12 . each wall 52 has an inside surface 54 which faces the opposite wall of the pair . a ledge 56 can be fixedly attached to each of the inside surfaces 54 . the ledge 56 is a linear formation of uniform thickness and uniform distance from the bottom surface 12 , which extends longitudinally along the entirety of the inside surface 54 . in an alternative embodiment , each of the parallel walls 52 can connect through a curved transition 53 , shown in fig3 , to an adjacent wall 52 from outside the pair of parallel walls 52 which is not parallel . the channels 50 extend into the bottom surface 12 to accommodate the extended length of the vanes 46 . additionally , recesses 51 can be formed on the bottom surface 12 parallel to long side surfaces 14 . the recesses 51 are similar in width to the channels 50 and receive the vanes 46 or rows 42 of posts 40 . the ledge 56 is located a distance from the bottom surface 12 equal to a distance from the toroidal flair 44 to the second flat end 43 of the post 40 . the walls 52 of the channel 50 are a distance apart substantially equal to the width of the posts 40 or the width of the vanes 46 . therefore , when two mounting blocks 10 are oriented with a top surface 11 and bottom surface 12 coming into contact , the posts 40 or vanes 46 will detachably attach securely within the channels 50 with the toroidal flair 44 directly above and adjacent to the ledge 56 , shown in fig2 , 23 and 25 ; and shown in phantom in fig8 and 9 . preferably , the mounting blocks 10 are of rectangular cross section when viewed from above the top surface 11 , as shown in fig2 having two long side surfaces 14 and two short side surfaces 15 . preferably , the mounting blocks 10 have four rows 42 of posts 40 with each row 42 being oriented orthogonal to a side surface 14 , 15 . the rows 42 which are perpendicular to short side surfaces 15 have three posts 40 in each row 42 and the rows 42 perpendicular to long side surfaces 14 have two posts 40 in each row 42 . each row 42 is replaceable by a vane 46 . in an alternative embodiment , each edge between the top surface 11 and the short side surfaces 15 has two tabs 47 , shown in fig3 and 35 , which extend perpendicularly away from the top surface 11 . the tabs 47 are rectangular plates which extend no farther from the top surface 11 as the posts 40 or vanes 46 . the tabs 47 may fit within a channel 50 of an adjoining bottom surface 12 of another mounting block 10 which is staggered in relationship to the other mounting blocks 10 . the tabs 47 provide additional stability to a group of stacked mounting blocks 10 . preferably , the bottom surface 12 is configured with four channels 50 , each channel 50 being perpendicular to a side surface 14 , 15 . in this configuration , the rows 42 of posts 40 or vanes 46 are aligned on the top surface 11 directly above the channels 50 on the bottom surface 12 . in an alternative embodiment , the channels 40 are oriented circumferentially around the bottom surface 12 in concentric rectangles . this configuration , shown in fig4 and fig5 , facilitates connection to a top surface 11 with posts 42 oriented as shown in fig4 and fig5 . preferably , the posts 40 are located a uniform distance apart from each other . this allows one mounting block 10 to connect to another mounting block 10 in various rotationally distinct top - to - bottom configurations . some variations are shown in detail in fig2 through 31 . when configured in this way , posts 40 from the same row 42 may even attach within separate channels 50 of an adjoining mounting block 10 . a mounting block 10 having vanes 46 may also connect to another mounting block 10 in various rotationally distinct top - to - bottom configurations . a mounting block 10 having posts 40 in a non linear pattern , as shown in fig4 and fig5 , may also connect to another mounting block 10 in various rotationally distinct top - to - bottom configurations . each of the side surfaces 14 , 15 of the mounting blocks 10 is equipped with either a prominence 70 or an orifice 80 . the prominence 70 and the orifice 80 are of complemental shape allowing the prominence 70 to attach within the orifice 80 , as shown in fig1 and 11 , thereby linking separate mounting blocks 10 through their adjoining side surfaces 14 , 15 . the prominence 70 is substantially a cylindrical construct having a hollow core 76 . the prominence 70 may extend outwardly orthogonally from either side surface 14 , 15 . the prominence 70 has a curved outer side wall 78 with a plurality of ribs 74 fixedly attached thereto extending along the side wall 78 in a direction perpendicular to the side surface 14 , 15 . in one embodiment , shown in fig3 through 35 , the prominence 70 has a lip 71 extending radially outwardly from the outer edge of the prominence 70 . the lip 71 holds the prominence 70 within the orifice 80 . a plurality of slits 72 are formed in the prominence 70 extending from the hollow core 76 to the side wall 78 and completely bisecting the prominence 70 in a plane perpendicular to the side surface 14 , 15 , as most clearly shown in fig6 . the hollow core 76 has an inner region 75 ( fig2 ) adjacent to the side surface 14 , 15 and an outer region 77 outward from the inner region 75 . the inner region 75 of the core 76 has a width greater than the width of the outer region 77 of the core 76 . the core 76 is of substantially similar diameter as is the diameter of the post 40 of the top surface 11 . two mounting blocks 10 may be connected by inserting the post 40 of the top surface 11 of one mounting block 10 into the core 76 of the side surface 14 , 15 of another mounting block 10 . the toroidal flair 44 of the post 40 can insert within the inner region 75 by deflecting the prominence along arrow &# 34 ; b &# 34 ;. this allows the post 40 and attached mounting block 10 to rotate relative to the core 76 of the prominence 70 and attached mounting block 10 . the orifice 80 is substantially a cylindrical recess which extends inwardly orthogonally from the side surface 14 , 15 . the orifice 80 has a curved side wall 88 with a plurality of undulations 84 formed thereupon and oriented to extend in a direction perpendicular to the side surface 14 , 15 . each undulation 84 extends from the side surface 14 , 15 , inward toward a center of the mounting block 10 . a generally circular , yet serpentine , cross - sectioned recess is thus formed . therefore , when two mounting blocks 10 are oriented with the side surfaces 14 , 15 adjacent to each other , the prominence 70 in the one side surface 14 , 15 may fit within the orifice 80 in the other side surface 14 , 15 by deflecting the prominence 70 in the direction opposite from arrow &# 34 ; b &# 34 ;. the ribs 74 of the prominence 70 fit complementally with the undulations 84 of the orifice 80 restricting the two mounting blocks 10 from relative rotation . also , the lip 71 of the prominence 70 holds the prominence 70 within the orifice 80 . because each rib 74 is of uniform width and uniform distance from adjacent ribs 74 and because each undulation 84 is of uniform width and uniform distance from adjacent undulations 84 , the side surfaces 14 , 15 of adjoining mounting blocks 10 may connect through the prominence 70 and orifice 80 in a variety of different orientations by rotation of one of the mounting blocks 10 relative to another of the mounting blocks 10 about an axis co - linear with a center axis of the prominence 70 and the orifice 80 , as shown in fig1 and 11 . preferably , one of the short side surfaces 15 of the mounting block 10 is equipped with a prominence 70 located at the center of the short side surface 15 . the other three side surfaces 14 , 15 are all equipped with orifices 80 . on the short side surface 15 , the orifice 80 is centrally located , but on the long side surfaces 14 the orifices 80 are located nearest to the short side surface 15 having the orifice 80 . in this way , all of the orifices 80 are located an equal distance from corners between the side surfaces 14 , 15 which have orifices 80 , for reasons to be explained later . reference numeral 20 is directed to a driving block , shown in detail in figures 12 through 18 . in essence , the driving block 20 is substantially a wafer - shaped construct having a top surface 21 , a bottom surface 22 and a plurality of side surfaces 24 , 25 . similar to the mounting block 10 of fig1 - 11 , the top surface 21 has a plurality of posts 40 . the bottom surface 22 has a plurality of channels 50 ( fig1 ). the side surfaces 24 , 25 have either a prominence 70 or an orifice 80 on each side surface 24 , 25 . the posts 40 are configured to fasten within the channels 50 and the prominences 70 are configured to fasten within the orifices 80 allowing a plurality of driving blocks 20 to be attached together in a variety of ways . in an alternative embodiment , rows 42 of posts 40 may be replaced with vanes 46 . more particularly , the driving block 20 includes a top surface 21 and bottom surface 22 which respectively define first and second attachment surfaces . these attachment surfaces are complemental allowing a plurality of driving blocks 20 to be connected top - to - bottom in a series . the attachment means of the top surface 21 is a plurality of posts 40 , shown in detail in fig8 preferably configured in rows 42 that radiate outward from a center of the top surface 21 . alternatively , the posts 40 may be oriented in a pattern such as that shown in fig4 and fig5 . each post 40 is preferably a substantially cylindrical construct fixedly attached on a first flat end 41 to the top surface 21 and extending outwardly perpendicular to the top surface 21 . alternatively , the posts may have a non circular cross - section . the geometry of the posts 40 is described more specifically hereinabove in connection with the description of the mounting blocks 10 . in an alternative embodiment , the rows 42 of posts 40 may be replaced with vanes 46 . also on the top surface 21 , linear webbing 90 is formed in a variety of positions beneath the top surface 21 , shown in fig1 . a top edge of the linear webbing 90 conforms to a plane coextensive with the top surface 21 in defining the exact location of the top surface 21 . the linear webbing 90 provides added structural strength to the driving blocks 20 and helps define the top surface 21 . the attachment means of the bottom surface 22 is a plurality of channels 50 , also shown in detail in fig9 that preferably radiate outward from a center of the bottom surface 22 . alternatively , the channels 50 may partially circumscribe the surface 22 as shown in fig4 and fig5 . the geometry of the channels 50 is described more specifically hereinabove in connection with the description of the mounting blocks 10 . preferably , a ledge 56 , shown in detail in fig9 is located a distance from the bottom surface 22 equal to a distance from a toroidal flair 44 , shown in detail in fig8 to the second flat end 43 of the post 40 . walls 52 of the channel 50 are a distance apart substantially equal to the width of the posts 40 and the width of the vanes 46 . therefore , when two driving blocks 20 are oriented with a top surface 21 and a bottom surface 22 coming into contact , the posts 40 ( or the vanes 46 ) will detachably attach securely within the channels 50 with the toroidal flair 44 directly above and adjacent to the ledge 56 . preferably the driving blocks 20 are of rectangular cross - section when viewed from above the top surface 21 , as shown in fig1 , having two long side surfaces 24 and two short side surfaces 25 . preferably , the driving blocks 20 have four rows 42 of posts 40 with each row 42 being oriented orthogonal to a side surface 24 , 25 . the rows 42 which are perpendicular to short side surfaces 25 have two posts in each row 42 and the rows 42 perpendicular to long side surfaces 24 have two posts 40 in each row 42 . preferably , the bottom surface 22 is configured with four channels 50 , each channel 50 being perpendicular to a side surface 24 , 25 . in this configuration , the posts 40 are aligned on the top surface 21 directly above the channels 50 on the bottom surface 22 . the posts 40 are located a distance apart from each other which allows a driving block 20 to connect to another driving block 20 in various rotationally distinct top - to - bottom configurations . when configured in this way , posts 40 from the same row 42 may attach within separate channels 50 of an adjoining driving block 20 . in an alternative embodiment , shown in fig4 and fig5 , only one row 42 of posts 40 extends from one side of the bottom surface 22 . when configured in this way , the posts 40 fit within the channel 50 on the top surface 21 , shown in fig4 and fig5 . each of the side surfaces 24 , 25 of the driving blocks 20 is equipped with either a prominence 70 or an orifice 80 . the prominence 70 and the orifice 80 are of complemental shape allowing the prominence 70 to attach within the orifice 80 , thereby linking separate driving blocks 20 through their adjoining side walls 24 , 25 . the geometry of the prominences 70 is described more specifically hereinabove in connection with the description of the mounting blocks 10 . the geometry of the orifices 80 is described more specifically hereinabove in connection with the description of the mounting blocks 10 . an orifice 80 can be located on the top surface 21 as shown in fig4 . this orientation allows the top surface 21 of the driving block 20 to connect with side surfaces 24 , 25 of another driving block 20 or to side surfaces 14 , 15 of a mounting block 10 . when two driving blocks 20 are oriented with side surfaces 24 , 25 adjacent to each other , the prominence 70 in the one side surface 24 , 25 may fit within the orifice 80 in the other side surface 24 , 25 or the top surface 21 . the ribs 74 of the prominence 70 fit complementally with the undulations 84 of the orifice 80 restricting the two driving blocks 20 from relative rotation . because each rib 74 is of uniform width and uniform distance from adjacent ribs 74 and because each undulation 84 is of uniform width and uniform distance from adjacent undulations 84 , the side surfaces 24 , 25 of adjoining driving blocks 20 may connect through the prominence 70 and orifice 80 in a variety of different orientations by rotation of one of the driving blocks 20 relative to another of the driving blocks 20 about an axis co - linear with a center of the prominence 70 and the orifice 80 . preferably , one of the long side surfaces 24 of the driving block 20 is equipped with a prominence 70 located at the center of the long side surface 24 . the other three side surfaces 24 , 25 are all equipped with orifices 80 . on the long side surface 24 the orifice 80 is centrally located , but on the short side surfaces 25 the orifices 80 may be located nearest to the long side surface 24 having the prominence 70 . in this way , all of the orifices 80 are located an equal distance from corners between the side surfaces 24 , 25 which have orifices 80 , for reasons to be explained later . the driving block 20 and mounting block 10 are of substantially similar design except for the difference in proportional length between the short side surfaces 25 and the long side surfaces 14 . thus , the two blocks 10 , 20 may function similarly in many ways . reference numeral 30 is directed to a gear block 30 , shown in detail in figures 19 through 21 . in essence , the gear block 30 is substantially a wafer - shaped construct having a top surface 31 , a bottom surface 32 and a side surface 33 . the top surface 31 has a plurality of posts 40 ( or vanes 46 and posts 40 as shown in fig3 ). the bottom surface 32 has a hub 60 . the side surface 33 has a plurality of beveled gear teeth 34 fixedly attached thereto . the posts 40 ( and vanes 46 ) are configured to fasten within the channels 50 of the mounting blocks 10 and the driving blocks 20 . the hub 60 is configured to fasten within the orifices 80 of the mounting blocks 10 and the driving blocks 20 allowing a plurality of gear blocks 30 to be attached to mounting blocks 10 and driving blocks 20 in a variety of ways , some of which are shown in fig2 and 23 . more particularly , the gear block 30 includes a top surface 31 and a bottom surface 32 which respectively define first and second attachment surfaces . the attachment means of the top surface 31 is a plurality of posts 40 , shown in detail in fig8 preferably configured in rows 42 that radiate outward from a center of the top surface 31 . each post 40 is a substantially cylindrical construct fixedly attached on a first flat end 41 to the top surface 31 and extending outwardly perpendicular to the top surface 31 . the geometry of the posts 40 is described more specifically hereinabove in connection with the description of the mounting blocks 10 . alternatively , the posts 40 may be configured in a variety of patterns such as that shown in fig4 and fig5 . the gear block 130 is an alternative embodiment of the gear block 30 , shown in fig3 through 38 , which involves replacing the rows 42 of posts 40 with a plurality of linear vanes 46 . the vanes 46 are of similar cross - section to the posts 40 and thus function similarly within channels 50 of the mounting blocks 10 and driving blocks 20 . interposed between the vanes 46 are a plurality of single posts 40 . the posts 40 may be used as connectors to apply rotation to the gear blocks 130 , 30 as will be described below . preferably , the gear blocks 30 have four rows 42 of posts 40 with each row 42 being orthogonal to adjacent rows 42 . preferably , each row 42 has two posts 40 . also on the top surface 31 , radially extending linear webbing 90 is formed in a variety of positions beneath the top surface 31 , as shown in fig1 . a top edge of the linear webbing 90 conforms to a plane coextensive with the top surface 31 and defining the exact location of the top surface 31 . also on said top surface 31 , circular webbing 93 is formed beneath the top surface 31 , as shown in fig1 . a top edge of the circular webbing 93 conforms to a plane coextensive with the top surface 31 and defining the exact location of the top surface 31 . the circular webbing 93 encircles each post 40 that is at an end of any of the rows 42 radially away from a center of the top surface 31 . the circular webbing 93 also encircles posts 40 interposed between vanes 46 . each encircled post 40 is at the center of the circular webbing 93 . the linear webbing 90 and circular webbing 93 provide added structural strength to the gear blocks 30 and help define the top surface 31 . the circular webbing 93 also supports any connection to an encircled post 40 as shall be evident . alternatively , the circular webbing 93 may be configured in a variety of patterns such as that shown in fig4 and fig5 . the attachment means of the bottom surface 32 is a hub 60 . the hub 60 is a hollow cylindrical construct located in a center of the bottom surface 32 of the circular gear blocks 30 . the hub 60 extends downward perpendicularly from the bottom surface 32 . the hub 60 has a plurality of slits 62 formed in a side wall 68 of the hub 60 in a plane perpendicular to the bottom surface 32 . a lip 64 is formed on an end of the hub 60 opposite the bottom surface 32 which extends radially outwardly from the side wall 68 . the hub 60 is of similar diameter and length to the prominence 70 of both the mounting blocks 10 and the driving blocks 20 , allowing connections as shown in fig2 and 23 . thus the hub 60 may fit within the orifice 80 of the mounting blocks 10 or the driving blocks 20 . the hub 60 may also attach over a post 40 if modified as shown in fig3 . the lip 64 of the hub 60 fits into the orifice 80 adjacent to the side surface 14 , 15 or the side surface 24 , 25 . the side wall 88 of the orifice 80 is slightly shorter than the length of the hub 60 . when the hub 60 is placed within the orifice 80 the lip 64 resides beyond the side wall 88 , thus retaining the hub 60 within the orifice 80 in a way similar to that of the prominence 70 . the hub 60 preferably does not have ribs 74 and so the hub 60 is free to rotate within the orifice 80 about arrow &# 34 ; a &# 34 ;. in this manner , a gear block 30 may attach to a mounting block 10 or a driving block 20 in a manner allowing rotation but restricting axial translation . the posts 40 are located a distance apart from each other which allows a mounting block 10 to connect to a gear block 30 in various rotationally distinct top - to - bottom configurations . when configured in this way , posts 40 from the same row 42 of the gear block 30 may attach within separate channels 50 of an adjoining mounting block 10 . the gear block 30 has a plurality of beveled gear teeth 34 fixedly attached to the side surface 33 . each tooth 34 extends radially outwardly perpendicular to the side surface 33 . the teeth 34 are separated from each other by a uniform distance such that gaps 35 between the teeth 34 are similar in width to the width of the teeth 34 . this allows adjacent gear blocks 30 to mesh in driving relation . each tooth 34 is beveled between the side surface 33 and the bottom surface 32 at an angle ∂. each gear block 30 is of similar size and has teeth 34 of similar size such that two distinct gear blocks 30 may be placed adjacent to each other with the teeth 34 of the one gear block 30 fitting within the gap 35 of the other gear block 30 . the two gear blocks 30 may interface in planes parallel to each other . they may also interface in two separate planes of the beveled gears 34 . in this case , the angle between the two planes is equal to two times the angle ∂ of each beveled gear 34 of each connected gear block 30 . preferably , the beveled angle ∂ will be 45 ° causing the two planes to be orthogonal . this allows the two gears 30 to interface at right angles to each other , as shown in fig2 and fig2 . when one interfacing gear block 30 is rotated , the other interfacing gear block 30 is caused to rotate . this action helps the user of the invention to better grasp the function of many mechanical devices . the interaction of the various blocks 10 , 20 and 30 can now best be appreciated in view of the previously described structure . the length of the long side surface 14 of the mounting block 10 is substantially equal to the diameter of a pitch circle 36 ( fig2 ) of the gear block 30 . when two mounting blocks 10 are connected to each other along complemental short side surfaces 15 , two orifices 80 , one from each mounting block 10 , are arranged capable of receiving two hubs 60 from two distinct gear blocks 30 . the teeth 34 of the gear blocks 30 then interface together in an operative orientation . furthermore , additional mounting blocks 10 and gear blocks 30 may be added to the first set of mounting blocks 10 and gear blocks 30 along both side surfaces 14 , 15 , top surfaces 11 and bottom surfaces 12 allowing gear blocks 30 mounted in orifices 80 to interact in a variety of ways including those shown in fig2 , 23 . also , three driving blocks 20 may be connected along side surfaces 24 , 25 allowing two gear blocks 30 with hubs 60 mounted in orifices 80 of the two outside driving blocks 20 to interact in a fashion similar to that of a pair of mounting blocks 10 . preferably , the distance from the orifice 80 located on the long side 14 to a corner 95 ( e . g . fig2 or 13 ) adjoining the short side surface 15 with the orifice 80 is equal to the distance from the orifice 80 of the short side surface 15 to the corner 95 . preferably , this distance between orifice 80 and corner 95 is equal to the radius of the pitch circle 36 ( fig2 ) along the bottom surface 32 . this allows two gear blocks 30 to fit into orifices 80 on adjacent side surfaces 14 , 15 of the mounting blocks 10 in a way allowing the teeth 34 of the gear blocks 30 to interface . in this configuration , two gear blocks 30 may interface while at right angles to each other , approximating the action of a beveled gear pair , as shown in fig2 . the core 76 of the prominence 70 of the driving block 20 or the mounting block 10 or the hub 60 of the gear block 30 may be attached over the encircled post 40 on the top surface 31 of the gear block 30 , as shown in fig2 . in this configuration , the driving block 20 or the mounting block 10 or the gear block 30 may act as an input driver for an assemblage of interfacing gear blocks 30 . the driving block 20 or the mounting block 10 or the gear block 30 can rotate relative to the post 40 of the gear block 30 , allowing a user to firmly grasp the driving block 20 or mounting block 10 or gear block 30 while rotating the gear blocks 30 . the circular webbing 93 which surrounds the posts 40 of the gear block 30 helps hold the prominence 70 of the driving block 20 or the mounting block 10 in place while the gear block 30 is rotated . a plurality of gear blocks 30 may be connected to a driving block 20 by location of hubs 60 within adjacent orifices 80 on the side surfaces 24 , 25 and the top surface 22 of the driving block 20 . this orientation allows the gear blocks 30 to attach to an assemblage of mounting blocks 10 and driving blocks 20 in more ways than otherwise possible . referring now to fig3 through 38 , a mounting block 150 and a gear block 130 are shown . the mounting block 150 is similar to the mounting block 10 except that various attachment means of the mounting block 150 have been modified to include alternative embodiments described above . the mounting block 150 interacts with the gear block 130 in a way similar to the interaction of the mounting block 10 with the gear block 30 . referring now to fig4 through 47 , a mounting block 110 , a driving block 160 and a gear block 170 are shown . these blocks 110 , 160 , 170 are similar to their counterpart blocks 10 , 20 , 30 , except that various attachment means have been modified and other minor changes have been made according to alternative embodiments described hereinabove . the blocks 110 , 160 , 170 interact with each other , as shown in fig4 , in a way similar to the interaction of the blocks 10 , 20 , 30 . however , the orifice 80 on the top surface 21 of the driving block 160 allows the blocks 110 , 160 to connect in a way allowing positioning of the orifices 80 of the blocks 110 , 160 in three mutually perpendicular planes . thus , gear blocks 170 connected to the blocks 110 , 160 can interface with each other while rotating in three mutually perpendicular planes simultaneously . referring now to fig5 through 54 , alternative embodiments of the blocks 110 , 160 , 170 are shown a mounting block 180 shows an alternative post 40 array and an alternative channel 50 configuration . a driving block 190 shows an alternative post 40 array and an alternative channel 50 configuration . a gear block 200 shows an alternative post 40 configuration conformable to the channel 50 configuration of the mounting block 180 and driving block 190 . referring now to fig3 and 40 , reference numeral 100 is directed to a wafer - like block which is shaped to be readily connectable both to the mounting blocks 10 , the driving blocks 20 , the gear blocks 30 and blocks described in u . s . application ser . no . 07 / 419 , 095 filed oct . 10 , 1989 . in essence , the wafer - like block 100 includes a top wall 102 which provides a first attachment surface and associated connecting means . bottom wall 112 provides a second attachment surface with uniting means . a peripheral channel 120 defines a third attachment area . note that walls 102 and 112 have a substantially square profile . thus , the first building element is polygonal and has n sides , where n equals 4 . the top wall 102 is formed with a plurality of wedges 104 which are configured as right triangles oriented such that each right triangle has a hypotenuse which faces along a diagonal of the block . thus , there are 2n wedges 104 for a total of 8 in this example . a plurality of spaces 106 extend radially between adjacent wedges 104 . these radially extending spaces 106 include deeper recesses 107 and describe the vanes 116 on the opposite side 112 of the block shown in fig4 . 2n spaces are provided which in this example provide a total of 8 spaces . a central hole 108 is provided which entirely bisects the walls 102 and 112 . the hole 108 is sized similarly to the orifice 80 in diameter . a collar 101 is located in the middle of the hole 108 which slightly reduces the diameter of the hole 108 in a central portion . the collar 101 is a distance from the walls 102 , 112 equal to the length of the prominence 70 and the hub 60 . thus , the lip 71 of the prominence 70 and the lip 64 of the hub 60 may be held in place within the hole 108 by the collar 101 . the hole 108 also has a plurality of undulations 184 which allow the hole 108 to hold the prominences 70 without allowing rotation . thus , in section a substantially u - shaped channel is provided where shelves 109 form the legs of the u - shaped channel . collectively , the channel 120 defines a third attachment surface which mates with a projection 140 on two other adjacent sides . the projection 140 is of a thickness similar to the width to the channel 120 and of complemental shape so that a projection 140 may fit within the channel 120 of an adjoining wafer - like block 100 . raised beads are formed on each shelf 109 to coact with a trough formed on the projection 140 , allowing the projection 140 to lock within the channel 120 . the truncations 152 of the wafer - like block 100 allow adjacent blocks to be placed in tangential registry in abutting relationship even at the corners . stated alternatively , when four wafer - like blocks 100 are arranged in a 2 × 2 array . the truncations 152 allow clearance for the 2 × 2 array to be interconnected . in use and operation , the wafer - like blocks 100 may connect to prominences 70 or hubs 60 through the hole 108 . also , the spaces 106 between the wedges 104 are sized to fit over the rows 42 of posts 40 or over the vanes 46 . moreover , having thus described the invention , it should be apparent that numerous structural modifications and adaptations may be resorted to without departing from the scope and fair meaning of the instant invention , as set forth hereinabove and as described hereinbelow by the claims .

US-68273091-A

two - part implant for attachment of artificial teeth comprising a base body having a bone contact surface and a soft tissue contact surface . said soft tissue contact surface is at least partially hydroxylated or silanated which results in an improved soft tissue integration .

in accordance with one embodiment of the invention , fig1 shows an implant 1 which is preferably made of a tissue compatible metal or of an alloy of such a metal , in particular of titanium or of a titanium alloy . alternatively the implant is made of ceramic , preferably of zirconia . further it is possible that parts of the implant are made of metal and parts of the implant are made of ceramic , for example if the inner part is made of titanium and the outer part of the implant is made of ceramic . the implant 1 has a threaded section 10 and a rounded lower end 15 . at its upper end it has a slightly enlarged conical section 20 . said implant 1 is subdivided into a bone contact surface b and a soft tissue contact surface s . in the boundary area of these surfaces , there is a transition area b / s from bone contact surface b to soft tissue contact surface s , which transition area is assigned to both aforementioned areas the question of whether this area , in the implanted state , is located in the bone or in the soft tissue depends on a large number of factors , for example the depth to which the implant is screwed , the tissue reaction , etc . the transition area has to be treated in the same way as the bone contact surface , in order to make sure , that in any case an optimal osteointegration is ensured . in the case of implants 1 made of titanium , the bone contact surface is preferably roughened , and even more preferred hydroxylated and hydrophilic as well . the soft tissue contact surface s is at least partially , preferably completely hydroxylated . in a preferred embodiment it is also roughened and / or hydrophilic . the soft tissue contact surface of an implant according to the present invention may be made of titanium , zirconium , tantalum , niobium , hafnium or alloys thereof as well as chemically similarly reacting alloys , but it is also possible that the implant has a ceramic coating which is hydroxylated . a common shape of dental implant in the form of a screw of diameter 4 mm and length 10 mm was produced . the crude shape was obtained in a manner known per se by removing material from the cylindrical blank by turning on a lathe and milling . the bone contact surface as well as the soft tissue surface were then sandblasted with particles having a mean size of 0 . 25 - 0 . 5 mm as described in ep 0 388 575 . the roughened surface was then treated for about five minutes at a temperature above 80 ° c . with an aqueous hydrochloric acid ( conc . )/ sulfuric acid ( conc .) mixture having an hcl : h 2 so 4 : h 2 o ratio of 2 : 1 : 1 . the implant formed in this way was washed with pure water and then heat - sealed directly in a glass ampoule filled with pure water containing 150 mm na + ions , and the corresponding amount of cl − anions . to test the soft tissue integration , the above implants were placed in four female fox hounds . each animal received 6 implants bilaterally in the upper jaw and 10 implants bilaterally in the lower jaw . the implants with a roughened hydroxylated soft tissue contact surface showed unexpectedly a much better soft tissue integration than comparable implants with an unhydroxylated surface . soft tissue adhesion was seen already after a few days , the soft tissue integration was apparent within two weeks . a common shape of dental implant in the form of a screw of diameter 4 mm and length 10 mm was produced . the crude shape was obtained in a manner known per se by removing material from the cylindrical blank by turning on a lathe and milling . the bone contact surface was then sandblasted with particles having a mean size of 0 . 25 - 0 . 5 mm , whereas the soft tissue contact surface has been electropolished . the sandblasted bone contact surface as well as the electropolished soft tissue contact surface were then treated for about five minutes at a temperature above 80 ° c . with an aqueous hydrochloric acid ( conc . )/ sulfuric acid ( conc .) mixture having an hcl : h 2 so 4 : h 2 o ratio of 2 : 1 : 1 . the implant formed in this way was washed with pure water and then heat - sealed directly in a glass ampoule filled with pure water containing 150 mm na + ions , and the corresponding amount of cl − anions . to test the soft tissue integration , the above implants were placed in four female fox hounds . each animal received 6 implants bilaterally in the upper jaw and 10 implants bilaterally in the lower jaw . the implants with a smooth hydroxylated soft tissue contact surface showed unexpectedly a much better soft tissue integration than comparable implants with an unhydroxylated surface . soft tissue adhesion was seen already after a few days , the soft tissue integration was apparent within two weeks .

US-68005507-A

the present invention relates to a releasing device and more particularly a releasing device used to release fish in water . deep - water fishes such as rockfish often exhibit the effects of rapid water pressure change such as expelled gas bladder , protruded eyes when brought to the surface . the fish releasing device of the present utilizes a jaw assembly , a weight , and other components to clamp onto a fish . the device is dropped into the water which pulls the fish beneath the surface of the water and automatically releases the fish upon the opening of the clamping jaw .

the present invention relates to a releasing device and more particularly a releasing device used to release fish in water . referring to fig1 through 5 , the fish releasing device 100 of the present invention will be discussed in more detail . in a first embodiment of the fish releasing device 100 of the present invention , the fish releasing device 100 comprises a jaw assembly 110 , a spring 120 , and a weight 130 . the jaw assembly 110 is made of two identical pieces of material cut in an s - like shape 110 a with an offset such that when the two identical pieces are assembled to form the jaw assembly 110 , at least one end of a first s - like shape 110 a will meet an end of the second s - like shape 110 a for gripping . the ends that meet for gripping are referred to as the gripping end of the jaw assembly 110 and the ends not required to meet are referred to as the non - gripping end of the jaw assembly 110 . the gripping end of the jaw assembly 110 may include a covering made of a soft material such as plastic or rubber to limit injuries to the fish being released . the s - like shapes 110 a are laid on top of each other such that a hole on the s - like shape 110 a is aligned and the tips on at least one end of the s - like shapes 110 a meet to form the gripping end on the jaw assembly 110 . the hole is ideally located near the center of each s - like shape 110 a . the other end of the s - like shapes 110 a which does not touch each other forms the non - gripping end of the jaw assembly 110 . to connect the s - like shapes 110 a for creating the jaw assembly 110 , any know means for attachment 200 may be used such as pins , screws , nuts and bolts , or rivets . the present invention uses a rivet that passes through the aligned hole when the s - like shapes 110 a are laid on top of each other . a nut and bolt may also be used and passed through the hole before the bolt is secured with a nut . other shapes for the jaw assembly 110 may be used as long as a gripping end is formed . a spring 120 is located between the non - gripping ends of the jaw assembly 110 wherein the spring 120 is connected to each non - gripping end . the spring 120 may be connected to the non - gripping ends of the jaw assembly 110 by any means for attachment 200 known such as pins , screws , rivets , nuts and bolts , or welding . the spring 120 is connected such that each end of the spring 120 is connected to one non - gripping end of the jaw assembly 110 . a weight 130 is connected to one of the non - gripping end of the jaw assembly 110 . the weight 130 may be connected to a hole on the non - gripping end of the jaw assembly 110 by tying the weight 130 to a string that is then passed through the hole and tied in place . other means for attachment 200 of the weight 130 may be used such as pins , screws , rivets , nuts and bolts , or welding . on the other non - gripping end of the jaw assembly 110 , or the end opposite the jaw assembly 110 with the weight 130 , an attachment mean 190 is provided for attaching a line to the fish releasing device 110 . the attachment mean 190 may be a hole located on the non - gripping end of the jaw assembly 110 . alternatively , an attachment mean 190 such as a ring may be connected to a string which is then connected to the hole on the non - gripping end . in a second embodiment , the structure of the fish releasing device 100 of the present invention is similar to the structure described in the first embodiment except that the weight 130 is connected to a lower interior pipe 140 prior to being connected to one of the non - gripping end of the jaw assembly 110 . the lower interior pipe 140 , while referred to as a pipe , may be hollow or solid . the lower interior pipe 140 may also be of any shape such as a cylinder , sphere , cube , pyramid , or triangle . in this embodiment , the weight 130 is connected to the lower interior pipe 140 by any means for attachment 200 such as a pin , screw , rivet , nut and bolt , or welding . the end of the lower interior pipe 140 that is not connected to the weight 130 may be connected to the non - gripping end of the jaw assembly 110 by tying the lower interior pipe aaa to a string that is then tied around the non - gripping end . other known means for attachment 200 of the lower interior pipe 140 to the non - gripping end of the jaw assembly 110 may be used such as pins , screws , rivets , nuts and bolts , or welding . alternatively , if a hole is providing on the non - gripping end of the jaw assembly 110 , the means for attachment 200 of the lower interior pipe 140 to the non - gripping end of the jaw assembly 110 may be passed through the hole . the lower interior pipe 140 may further comprise a slot and a first hole for receiving and connecting to the non - gripping end of the jaw assembly 110 with the weight 130 . in this configuration , a non - gripping end of the jaw assembly 110 is inserted into the slot such that the hole in the non - gripping end of the jaw assembly 110 is aligned with the first hole on the lower interior pipe 140 . to attach the lower interior pipe 140 and non - gripping end of the jaw assembly 110 , any means for attachment 200 such as a pin , screw , rivets , nut and bolt , or welding or similar means for attaching is provided . the means for attachment 200 is inserted into the hole on one side of the lower interior pipe 140 , passed through the hole in the non - gripping end of the jaw assembly 110 , and then passed through the hole on the other side lower interior pipe 140 . the means for attachment 200 may be secured into place to prevent it from slipping out of the holes . alternatively , the means for attachment 200 may be inserted into the hole on one side of the lower interior pipe 140 , passed through the hole in the non - gripping end of the jaw assembly 110 , through a loop at one end of the spring 120 , and then through the hole on the other side of the non - gripping end of the jaw assembly 110 . the means for attachment 200 may be secured into place to prevent it from slipping out of the holes . the lower interior pipe 140 may further comprise a second hole at the end opposite the first hole , wherein the second hole is used for receiving a means for attachment 200 to connect the weight 130 to the lower interior pipe 140 . the means for attachment 200 is inserted into the hole on one side of the lower interior pipe 140 , passed through a hole in the weight 130 , and then passed through the hole on the other side of the lower interior pipe 140 . the means for attachment 200 may be secured into place to prevent it from slipping out of the holes . in a third embodiment , the structure of the fish releasing device 100 of the present invention is similar to the structure described in the first embodiment except attachment mean 190 is connected to an upper interior pipe 150 prior to being connected to one of the non - gripping end of the jaw assembly 110 . the upper interior pipe 150 , while referred to as a pipe , may be hollow or solid . the upper interior pipe 150 may also be of any shape , such as a cylinder , sphere , cube , pyramid , or triangle . in this embodiment , the attachment mean 190 is connected to the upper interior pipe 150 by any means for attachment 200 such as a pin , screw , rivet , nut and bolt , or welding . the end of the upper interior pipe 150 that is not connected to the attachment mean 190 may be connected to the non - gripping end of the jaw assembly 110 by tying the upper interior pipe 150 to a string that is then tied around the non - gripping end . the upper interior pipe 150 may be attached by any means for attachment 200 to the non - gripping end of the jaw assembly 110 such as pins , screws , rivets , nuts and bolts , or welding . alternatively , if a hole is provided on the non - gripping end of the jaw assembly 110 , the means for attachment 200 of the upper interior pipe 150 to the non - gripping end of the jaw assembly 110 may be passed through the hole . the upper interior pipe 150 may further comprise a slot and a first hole for receiving and connecting to a non - gripping end of the jaw assembly 110 . in this configuration , a non - gripping end of the jaw assembly 110 is inserted into the slot such that the hole in the non - gripping end of the jaw assembly 110 is aligned with the first hole on the upper interior pipe 150 . to attach the upper interior pipe 150 and non - gripping end of the jaw assembly 110 , any means for attachment 200 such as a pin , screw , rivet , nut and bolt , welding or similar means for attaching is provided . the means for attachment 200 is inserted into the hole on one side of the upper interior pipe 150 , passed through the hole in the non - gripping end of the jaw assembly 110 , and then passed through the hole on the other side of the upper interior pipe 150 . the means for attachment 200 may be secured into place to prevent it from slipping out of the holes . alternatively , the means for attachment 200 may be inserted into the hole on one side of the upper interior pipe 150 , passed through the hole in the non - gripping end of the jaw assembly 110 , through a loop at one end of the spring 120 , and then through the hole on the other side of the upper interior pipe 150 . the means for attachment 200 is secured into place to prevent it from slipping out of the holes . the upper interior pipe 150 may further comprise a second hole at the end opposite the first hole , wherein the second hole is used for receiving a means for attachment 200 , to connect the attachment mean 190 to the upper interior pipe 150 . the means for attachment 200 is inserted into the hole on one side of the upper interior pipe 150 , passed through a hole in the attachment mean 190 , and then passed through the hole on the other side of the upper interior pipe 150 . the means for attachment 200 may be secured into place to prevent it from slipping out of the holes . in a fourth embodiment of the fish releasing device 100 of the present invention , the new features in the second and third embodiments are combined with the features in the first embodiment to obtain the fourth embodiment of the present invention . the fourth embodiment comprises a weight 130 connected to a lower interior pipe 140 . the end of the lower interior pipe 140 not connected to the weight 130 is connected to one of the non - gripping end of the jaw assembly 110 . on the non - gripping end of the jaw assembly 110 opposite the one not connected to the weight 130 , an upper interior pipe 150 is connected to the non - gripping end . an attachment mean 190 is connected to the end of the upper interior pipe 150 that is not connected to the non - gripping end of the jaw assembly 110 . the means for attachment 200 of the various components are similar to those discussed for the first , second , and third embodiments . in a fifth embodiment of the present invention , which is a modification of the second embodiment , the second embodiment further includes a lower swivel 160 which connects the weight 130 to the lower interior pipe 140 . the end of the lower interior pipe 140 which is not connected to the lower swivel 160 and weight 130 is connected to one of the non - gripping end of the jaw assembly 110 . any means for attachment 200 for connecting the various components may be used such as those discussed in the second embodiment . if the lower interior pipe 140 comprises a second hole at the end opposite the first hole , the second hole may be used for receiving a means for attachment 200 , to connect the lower swivel 160 to the lower interior pipe 140 . the means for attachment 200 is inserted into the hole on one side of the lower interior pipe 140 , passed through a hole in the lower swivel 160 , and then passed through the hole on the other side of the lower interior pipe 140 . the means for attachment 200 may be secured into place to prevent it from slipping out of the holes . in a sixth embodiment of the present invention , the third embodiment is modified to further include an upper swivel 170 which connects the attachment mean 190 to the upper interior pipe 150 . the end of the upper interior pipe 150 which is not connected to the upper swivel 170 and attachment mean 190 is connected to one of the non - gripping end of the jaw assembly 110 . any means for attachment 200 for connecting the various components may be used such as those discussed in the third embodiment . if the upper interior pipe 150 comprises a second hole at the end opposite the first hole , the second hole may be used for receiving a means for attachment 200 , to connect the upper swivel 170 to the upper interior pipe 150 . the means for attachment 200 is inserted into the hole on one side of the upper interior pipe 150 , passed through a hole in the upper swivel 170 , and then passed through the hole on the other side of the non - gripping end of the jaw assembly 110 . the means for attachment 200 may be secured into place to prevent it from slipping out of the holes . in a seventh embodiment of the present invention , the embodiments disclosed in the fifth and sixth embodiments are combined to obtain the seventh embodiment . the seventh embodiment includes a lower swivel 160 which connects the weight 130 to the lower interior pipe 140 . the end of the lower interior pipe 140 which is not connected to the lower swivel 160 and weight 130 is connected to one of the non - gripping end of the jaw assembly 110 . the seventh embodiment further includes an upper swivel 170 which connects the attachment mean 190 to the upper interior pipe 150 . the end of the upper interior pipe 150 which is not connected to the upper swivel 170 and attachment mean 190 is connected to the non - gripping end of the jaw assembly 110 opposite the non - gripping end with the weight 130 . any known means for attachment 200 for connecting the various components may be used such as those discussed in the second and third embodiment . in an eighth embodiment of the present invention , a main body 180 is provided to house the various components of the fish releasing device 100 . the main body 180 may house any of the embodiments discussed above . depending on the embodiment to be housed , main body 180 may house the lower interior pipe 140 , lower swivel 160 , upper interior pipe 150 , upper swivel 170 , spring 120 , and / or non - gripping ends of the jaw assembly 110 . main body 180 is hollow and may be cylindrical . however , it may be of any shape as long as it is of sufficient size to house the components of the fish releasing device 100 . main body 180 may further comprise at least one opening for receiving the non - gripping ends of the jaw assembly 110 . there may also be holes in the main body 180 for allowing the passing through of means for attachment 200 to connect the various components . to assemble the fish releasing device 100 with a main body 180 , the lower interior pipe 140 is slid into the main body 180 until a hole in the lower interior pipe 140 lines up with the hole in the main body 180 . the slot on the lower interior pipe 140 is also aligned with the opening in the main body 180 for receiving the non - gripping ends of the jaw assembly 110 . a means for attachment 200 is inserted into the aligned hole and driven in approximately ⅓ of the way through . a spring 120 is inserted into the main body 180 until the lower loop on the spring 120 is over the means for attachment 200 . the lower non - gripping end of the jaw assembly 110 is inserted until all the holes and lower loop on the spring 120 are aligned . the means for attachment 200 is then driven until it is flushed with the inside of the main body fff . the lower interior pipe 140 is moved to make sure the lower interior pipe 140 freely slides inside the main body 180 . the upper interior pipe 150 is then inserted from the top end of the main body 180 . the lower interior pipe 140 and jaw assembly 110 may be moved down if necessary prior to inserting the upper interior pipe 150 . the hole and slot on the upper interior pipe 150 are aligned with the hole and opening on the main body 180 , respectively . a means for attachment 200 , such as a pin , is inserted through the hole in the main body 180 approximately ⅓ of the way . a hook tool is used to reach down the inside of the main body 180 to grab the top loop end of the spring 120 and place it over the means for attachment 200 . the non - gripping end of the jaw assembly 110 is slid into the opening in the main body 180 and aligned with the means for attachment 200 and holes . the means for attachment 200 is driven until it is flush with the main body 180 . ideally , the hole in the main body 180 should be larger than the means for attachment 200 and the hole on the other components of the fish releasing device 100 . the hole on the other components of the fish releasing device 100 should be large enough to receive the means for attachment 200 without allowing it to pass completely through . referring to fig6 , operation of the fish releasing device is discussed . to use the fish releasing device 100 , the fish to be returned is removed from the fishing hook or net . the fish releasing device 100 is attached to a line prior to lowering of the fish and fish releasing device 100 into the water . the weight 130 on the fish releasing device 100 is supported which causes the jaw assembly 110 to remain in the open position . the mouth of the fish is placed between the opened gripping ends of the jaw assembly 110 . support to the weight 130 is released . this clamps the gripping end of the jaw assembly 110 of the fish releasing device 100 to the fish to be released . once clamped onto the fish , the fish releasing device 100 and fish is lowered into the water until the gripping end of the jaw assembly 110 of the fish releasing device 100 opens to release the fish . the gripping end of the jaw assembly 110 automatically opens when the tension caused by the weight 130 on the jaw assembly 110 is diminished . this can occur when the weight 130 hits a surface in the ocean , such as the bottom of the ocean . when the weight hits a surface , the lower interior pipe 140 will travel up towards the top because of the spring 120 . this will open the gripping end of the jaw assembly 110 since they are no longer held closed by the weight 130 but pulled open by the spring 120 . the fish is therefore freed . all the features disclosed in this specification , including any accompanying abstract and drawings , may be replaced by alternative features serving the same , equivalent or similar purpose , unless expressly stated otherwise . thus , unless expressly stated otherwise , each feature disclosed is one example only of a generic series of equivalent or similar features . while specific systems and methods have been disclosed in the preceding description , it should be understood that these specifics have been given for the purpose of disclosing the principles of the present invention and that many variations thereof will become apparent to those who are versed in the art .

US-98517707-A

apparatus for assembling blocks of parallel cigarettes in formations ready for packing has a magazine for a supply of parallel cigarettes and three groups of downwardly extending ducts whose upper ends communicate with the magazine to admit parallel cigarettes and whose lower end portions are located at a block building station . the end portions of the two outer groups of ducts are located in horizontal planes , one above the other , and the end portion of each duct of one outer group registers with the end portion of a duct of the other outer group . the end portions of the median group of ducts are vertical or nearly vertical and are located between the end portions of the two outer groups of ducts . the rows of parallel cigarettes which accumulate in the end portions of the ducts are expelled simultaneously by a pusher whereby the expelled cigarettes pass through a mouthpiece which completes their conversion into a block . the cigarettes descend in the ducts by gravity and owing to the weight of cigarettes in the magazine . since the block building station receives cigarettes from more than two discrete groups of ducts , the accumulation of rows which can be converted into a block takes up a short interval of time .

the block assembling or forming apparatus of fig1 and 2 comprises a magazine or bin 1 which contains a supply of parallel rod - shaped articles 7 , e . g ., plain or filter - tipped cigarettes . the magazine comprises spaced - apart upright front and rear walls 2 , 3 which may but need not extend all the way down to a block forming or building station 19 . fig1 merely shows the lower part of the magazine 1 ; this lower part contains two triangular baffles 4 and 6 which subdivide the respctive portion of the interior of the magazine into three compartments 8 , 9 and 11 . the baffles 4 and 6 can but need not extend all the way across the interior of the magazine 1 , i . e ., all the way from the front wall 2 to the rear wall 3 . the lower part of the compartment 8 communicates with the inlets of three elongated ducts 16 which form a first group 12 , and the lower part of the compartment 11 communicates with the inlets of three elongated ducts 16 which form a second group 14 . the ducts 16 of the group 12 are mirror symmetrical to the ducts 16 of the group 14 with reference to a vertical plane which is normal to the plane of fig1 and halves the median compartment 9 . the lower part of the compartment 9 communicates with the inlets of three additional ducts 16 which form a third or additional group 13 and are vertical or nearly vertical . the lower end portions 21 and 22 of the ducts 16 of the first and second groups 12 and 14 are horizontal and are disposed one above the other . the right - hand ends of the lower end portions 21 and the left - hand ends of the lower end portions 22 are open , and each end portion 21 is aligned with one of the end portions 22 . the lower end portions 23 of the ducts 16 forming the additional group 13 extend into the space between the end portions 21 and 22 . the walls of the ducts 16 are shown at 17 . it will be seen that the lower end portions 24 of the left - hand wall 17 of the leftmost duct 16 of the group 13 closes the open ends of the end portions 21 and that the lower end portion 26 of the right - hand wall 17 of the rightmost duct 16 of the group 13 closes the open ends of the end portions 22 . the walls 17 of the ducts 16 of the groups 12 and 14 slope downwardly and the cigarettes 7 which enter these ducts ( as well as the vertical ducts of group 13 ) descend therein by moving sideways . the thickness of the walls 17 preferably decreases in a direction toward the block building station 19 which is formed by the end portions 21 - 23 of the ducts 16 and which can accumulate a block 43 consisting of twenty - one cigarettes 7 forming three horizontal layers . each end portion 21 contains a horizontal row 31 of two parallel cigarettes 7 , each end portion 22 contains a horizontal row 32 of two parallel cigarettes 7 , and each end portion 23 contains a vertical row 33 of three parallel cigarettes . thus , the rows 33 are inclined with respect to the rows 31 , 32 and the rows 31 , 32 flank the rows 33 . the lower end portions of the walls 17 of all of the ducts may consist of thin sheet metal to thus reduce the spacing between the rows 31 , 32 or 33 . the lower ends of the end portions 23 are closed by a base plate 29 which may but need not be integral with the wall portions boundimg the undersides of the two lowermost end portions 21 , 22 . the upper end face of each wall 17 is adjacent to a preferably driven agitating roller 18 . the means for rotating these rollers is preferably designed to turn them back and forth to thus reduce the likelihood of bridging of cigarettes at the inlets of the ducts 17 and the likelihood of misalignment of cigarettes in the compartments 8 , 9 , 11 , as well as to promote the entry of cigarettes into the ducts 16 wherein the cigarettes move sideways and enter the respective end portions 21 , 22 , 23 to form the rows 31 , 32 , 33 . the thickness of the upper end portions of the walls 16 preferably equals or approximates the diameters of the agitating rollers 18 . the axes of the rollers 18 are parallel to the axes of cigarettes 7 in the magazine 1 and in the ducts 16 . it is preferred to use agitating rollers having grooved or ribbed peripheral surfaces whereby the grooves or ribs extend in the longitudinal direction of cigarettes 7 . the curvature of each duct 16 of the groups 12 and 14 is preferably gradual and sufficiently pronounced to allow the cigarettes 7 to travel rapidly toward the block forming station 19 without any misalignment and within a short period of time . the height of a row 33 is less than the combined height of the rows 31 because the rows 31 are separated from each other by the relatively thin lower end portions 27 of walls 17 of the ducts 16 of group 12 . this also applies for the height of the rows 33 and the combined height of the rows 32 ( see the end portions 28 of the walls 17 of ducts 16 forming the group 14 ). the front wall 2 of the magazine 1 is formed with an outwardly extending nipple or mouthpiece 34 which registers with the station 19 , whose cross - sectional area decreases gradually in a direction away from the rear wall 3 , and which communicates with the end portions 21 - 23 of the ducts 16 . the means for expelling blocks 43 of twenty - one cigarettes 7 each from the block forming station 19 comprises a transfer member or pusher 37 which is normally located behind the rear wall 3 and is movable in directions indicated by a double - headed arrow 38 . the pusher 37 has nine projections or fingers 36 which can enter the station 19 by passing through openings in the rear wall 3 and each of which can transfer a row 31 , 32 or 33 from the respective end portion 21 , 22 or 23 into the mouthpiece 34 . once the rows 31 - 33 enter the mouthpiece 34 , they are converted into a final or finished block wherein each of the three layers contains seven closely adjacent cigarettes 7 and wherein each cigarette of the medial layer is located exactly between a cigarette of the upper layer and a cigarette of the lower layer . the minimum cross - sectional area of the passage which is defined by the mouthpiece 34 is selected with a view to compact the block 43 to such an extent that the block can be readily introduced into the pocket of a turret forming part of a cigarette packing machine , into a hollow mandrel in a packing machine , or directly into a partially finished soft or flip - flop pack . for the sake of clarity , the cigarettes 7 which form the rows 31 , 32 and 33 at the station 19 of fig1 are identified by hatching . the maximum frequency at which the pusher 37 can perform working strokes ( in a direction to the left , as viewed in fig2 ) is determined by the length of a first interval which is required to withdraw the fingers 36 from the station 19 plus the length of a second interval which is required to allow for renewed filling of the station 19 with rows 31 - 33 which together form a block 43 of twenty - one cigarettes . it has been found that the length of the second interval can be reduced considerably by the provision of ducts 16 which form the additional groups 13 , i . e ., by placing additional ducts between those ducts ( or groups 12 and 14 ) whose lower end portions are horizontal . this is due to the fact that the improved apparatus enables the cigarettes 7 to enter the block building station 19 from three different directions . it is clear that the additional group 13 may comprise a single duct 16 , two ducts or more than three ducts , and that the ducts of the group 13 may be assembled into two or more subgroups . also , the walls 2 and 3 need not close the ends of ducts 16 between the lower ends of the compartments 8 , 9 , 11 and the block forming station 19 . the mouthpiece 34 may constitute a discrete part which is mounted in register with the front side of the station 19 . the lowermost cigarettes 7 of the vertical rows 33 are located in a common horizontal plane with the cigarettes 7 of the lowermost rows 31 and 32 . fig3 shows a portion of a second apparatus wherein all such parts which are identical with or clearly analogous to the corresponding parts of the first apparatus are denoted by similar reference characters plus 100 . the compartments of the magazine ( not shown ) communicate with the inlets at the upper ends of ducts 116 which form a first group 112 , a second group 114 which is mirror symmetrical to the group 112 , and an additional group 113 which comprises four vertical ducts . each of the groups 112 , 114 comprises two ducts . each of the two rows 131 of cigarettes 107 in the horizontal lower end portions 121 of the ducts 116 of the first group 112 consists of three parallel cigarettes , each row 132 in the end portion 122 of a duct 116 of the group 114 also consists of three parallel cigarettes 107 , and each row 133 in the lower end portion 123 of a duct 116 of the group 113 consists of two cigarettes . the block 143 ( indicated by broken lines ) contains two layers of ten cigarettes each . thus , the modified block building or forming station 139 of fig3 is designed in such a way that it can receive eight rows of cigarettes 107 ( therefore , the pusher which is used in the apparatus of fig3 can have eight fingers ) and the resulting block can fill a flat flip - top pack contaning twenty cigarettes 107 which form two layers . it will be noted that the number of ducts 116 forming the group 112 again equals the number of ducts which form the group 114 , but that this number is different from the number of ducts which form the additional group 113 . the apparatus of fig4 constitutes a second modification of the apparatus of fig1 - 2 and all such parts thereof which are identical with or clearly analogous to the corresponding parts of the first apparatus are denoted by similar reference characters plus 200 . the lower end portions 246 of the ducts 216 which form the additional group 213 make an obtuse angle with the horizontal lower end portions 221 , 222 of the ducts 216 which form the first and second groups 212 , 214 . this renders it possible to assemble at the station 244 a block 253 which contains a total pf twenty cigarettes 207 and which consists of three layers whereby the cigarettes of the block 243 are in the customary array having two outer layers 249 , 252 of seven cigarettes each and a median layer 251 of six cigarettes . the cigarettes 207 of the median layer 251 are staggered with respect to the cigarettes of the two outer layers 249 , 252 . it is clear that each of the three groups of ducts 16 , 116 or 216 can receive rod - shaped articles from a discrete magazine or bin or that two of the three groups of ducts can receive cigarettes from a common source . the lower end portions of ducts which form the additional group are vertical or nearly vertical ( see fig1 - 2 or fig3 ) when the apparartus is to assemble blocks wherein each layer contains the same number of articles . the utilization of additional ducts whose lower end portions are not normal to the end portions of the first and second groups of ducts renders it possible to assemble blocks wherein at least one of the layers contains a different number of articles . an advantage of the improved apparatus is that the block forming station receives cigarettes or analogous rod - shaped articles ( e . g ., plain or filter - tipped cigars or cigarillos ) which enter the lower end portions of the respective ducts by moving sideways in three different directions . thus , the cigarettes 7 , 107 , 207 which travel in the ducts of the first group enter the block forming station by moving in a direction to the right , the cigarettes which descend in the ducts of the second grup enter the block forming station by moving in a direction to the left , and the cigarettes in the ducts of the additional group enter the block forming station by moving substantially or exactly vertically downwardly . this reduces the overall length of that interval which is needed to fill the block forming station with a requisite number of cigarettes . moreover , the provision of one or more additional ducts renders it possible to assembly blocks containing any desired number of cigarettes and in any one of several presently preferred arrays . the improved apparatus has been found to be especially useful for the assembly of blocks ( 143 ) of the type shown in fig3 wherein each of a relatively small number of layers ( two ) contains a relatively large number of cigarettes ( ten ). the assembly of such blocks in conventional apparatus is time - consuming and is likely to result in deformation of or other damage to the articles during expulsion from the block forming station . rapid assembly of blocks is highly desirable when such blocks are to be introduced into a modern high - speed packing machine for cigarettes or the like because the operating speed of such machine is determined primarily by the frequency at which it can receive blocks of properly arrayed rod - shaped articles . if desired , the articles which travel in the ducts toward the block forming station can be accelerated by resorting to suction and / or to a compressed gaseous fluid however , it has been found that the apparatus will operate quite satisfactorily , particularly as regards the frequency at which it assembles blocks of rod - shaped articles if the articles are allowed to descend by gravity and if the number of articles which are supplied by the ducts of the additional group at least equals but preferably exceeds the number of articles which are supplied by the ducts of the first or second group . as shown in fig1 the group 13 delivers nine out of twenty - one cigarettes which form a block 43 . in fig3 the group 113 delivers eight out of twenty cigarettes 107 . in fig4 the group 213 delivers as many as nine out of twenty cigarettes 207 . without further analysis , the foregoing will so fully reveal the gist of the present invention that others can , by applying current knowledge , readily adapt it for various applications without omitting features which fairly constitute essential characteristics of the generic and specific aspects of our contribution to the art and , therfore , such adaptations should and are intended to be comprehended within the meaning and range of equivalence of the claims .

US-50839274-A

a method and system for estimating the volume of blood ejected from the left ventricle of the heart to a succeeding chamber / conduit , or vice - versa , while imaging the intersection of such structures is described . the process utilizes either the m - mode to estimate volume differences in a view of the ventricle over time or doppler processing techniques to obtain flow profiles across intersections , or blood vessels , which are then utilized to calculate output . this process can be combined with ecg guidance / triggering to measure / track changes in output from beat to beat , or during the course of an evaluation or therapeutic procedure . this process can be specifically used for the placement of permanent pacemaker electrodes .

the present invention provides an ultrasound imaging system suitable for measuring cardiac output of a patient &# 39 ; s heart , said system comprising : ( 1 ) an ultrasound imaging catheter comprising at least one transducer utilizing piezoelectric properties to generate acoustic signals from electrical signals in order to obtain ultrasound signals , wherein the at least one transducer is suitable for insertion into the patient &# 39 ; s heart and to obtain ultrasound signals associated with an area of the patent &# 39 ; s heart in which cardiac output is to be measured ; ( 2 ) digital and / or analog electronics capable of generating and processing ultrasound signals from the at least one transducer to generate b - mode , m - mode , or doppler representations of the cardiac output of the patient &# 39 ; s heart ; and ( 3 ) an associated computer that can generate and process the ultrasound signals in order to measure the cardiac output in the patient &# 39 ; s heart . this invention also provides a method of placing an electrode at a desired position at or near the left ventricle of a patient &# 39 ; s heart in order to electrically activate the left ventricle of the patient &# 39 ; s heart using the electrode , said method comprising : ( 2 ) placing an ultrasound imaging catheter in a position to image the left ventricle of the patient &# 39 ; s heart , wherein the ultrasound imaging catheter comprises at least one transducer utilizing piezoelectric properties to generate acoustic signals from electrical signals in order to obtain ultrasound signals and wherein the at least one transducer is suitable for insertion into the patient &# 39 ; s heart and to obtain ultrasound signals associated with an area of the patent &# 39 ; s heart ; ( 3 ) utilizing the ultrasound imaging catheter to image the electrode at or near the left ventricle of a patient &# 39 ; s heart and to guide the electrode to the desired position ; and ( 4 ) attaching the electrode to the desired position . one preferred desired position for attachment of the electrode is the upper portion of the left ventricle ( i . e ., nearer the base of the heart as compared to the apex ). in one preferred embodiment , at least one transducer has a defecting or rotation element whereby the transducer , once positioned to image the left ventricle of the patient &# 39 ; s heart , can be easily rotated or moved in order to image other portions of the patient &# 39 ; s heart . the present invention also provides an ultrasound imaging system to assist in cardiac electrophysiology procedures related to a patient &# 39 ; s heart , said system comprising : ( 1 ) an ultrasound imaging catheter comprising a multi - element array transducer utilizing piezoelectric properties to generate acoustic signals from electrical signals in order to obtain ultrasound signals , wherein the multi - element array transducer is suitable for insertion into the patient &# 39 ; s heart and to obtain ultrasound signals associated with the patent &# 39 ; s heart ; ( 2 ) digital and / or analog electronics capable of generating and processing ultrasound signals from the multi - element array transducer to generate and display a representation of ( a ) the electrocardiogram of the patient &# 39 ; s heart , ( b ) a real time image of the patient &# 39 ; s heart , or ( c ) the cardiac output of the patient &# 39 ; s heart . in a preferred embodiment , the representation ultrasound signals can be displayed relative to , and compared to , a voltage conduction map of the patient &# 39 ; s heart ( i . e ., a representation of the progression of electrical activation / deactivation or “ action potentials ” of the muscles of the heart ). the basis of the measurement / estimation process of the present invention is shown in fig6 and 7 . using the doppler process ( fig6 ), the amplitude of the velocity profile is halved to provide the average velocity across the flow area ( fig6 a ). the velocity is integrated ( fig6 b ) with respect to time from the start of the pulse ( t 0 ) to the end of the pulse ( t 1 ). such integration can also include the negative peaks shown in fig4 a to compensate for reverse flows . the result of this integration with respect to time is then multiplied by the cross - sectional area of the flow to provide the ejection volume ( fig6 c ). the integration length can also be set by integrating during the complete cardiac cycle ( i . e ., through one complete cycle of the ecg ). the spectrum in fig6 can also be obtained by either frequency and / or amplitude plotting of an audio signal . v ejt = a ⁢ ⁢ ∫ v peak 2 ⁢ ⅆ t eq . ⁢ 1 using the m - mode process ( fig7 ), the system outputs the relative position of the two walls of the ventricle as a function of time . the ventricle can be equated to an ellipsoid shape , whose secondary radius is represented by the distance between the two walls measured by the m - mode . the primary equation to the volume would then be v =( π ( r 1 + c 1 ) r 2 )( 2 πr 2 )± c 2 eq . 2 c 1 = a correction factor to compensate for the difference in morphology of the ventricle w . r . t . an ellipse ; and c 2 = correction in the primary radius to compensate for longitudinal contractility of the ventricle during a cardiac cycle . volume can then be calculated at systole and diastole ( determined either with correlation to the ecg , as shown in fig7 or by determining the minimum and maximum of the m - mode curve ). the stroke volume is then given by one embodiment of the present invention is in the form of hardware and / or software that exists as part of the ultrasound scanner ( fig1 ). in such an embodiment , the system utilizes the doppler processing capabilities of the host ultrasound scanner to obtain a time - varying signal representative of the velocity of flow through an area of interest . such area could include the inlet of the aorta from the left ventricle , or the valve in between . the system also utilizes a view / measure of the cross - sectional area through which the flow of interest is to pass ( fig5 ). the doppler system outputs the spectral information , which is indicative of the velocity of flow through the volume of interest ( as shown in fig3 ) either by means of showing a spectrum ( which in some embodiments can be obtained in a analog or digital format from the machine ). such a spectrum can be obtained either by obtaining a longitudinal sectional view of the flow axis at any angle ( as represented in fig3 ), or by obtaining a cross sectional view of the flow conduit ( fig5 ). such calculations of flow / area can be compensated for the angle of measurement using a cosine of the angle w . r . t . actual plane correction . for conditions where the flow is perpendicular to the sample volume of the doppler system , other estimation techniques such as “ transverse doppler ,” which utilizes the doppler bandwidth to assess flow at flow to beam angles close to 90 degrees , can be utilized . tortoli et al ., ultrasound med . biol ., 21 , 527 – 532 ( 1995 ). this doppler signal can also be as an audio signal ( again , either in analog or digital format ) as a frequency and / or amplitude modulated signal that is indicative of the spectrum and hence the flow velocity through the area of interest . this could further include ecg signals ( again , in analog or digital format ). further processing can be carried out , for example , using the following techniques : 1 . a largely manual process wherein the user measures / demarcates , either with or without the aid of an ecg , the peak velocities at least one point on the spectrum and demarcates / measures the cross - section of the outlet of the ventricle ; and the system / calculating tool ( either on the ultrasound machine or on a separate computer ) the integrates the curve over time to obtain stroke volume via equation 1 . 2 . a semi - automated process wherein the system ( either on the ultrasound machine or separate ) automatically integrates the curve with or without the help of an ecg while the user inputs the area of interest of the orifice through which the flow passes . 3 . a fully automated process wherein the system prompts the user to obtain particular views of the anatomy of interest and demarcate specific points and the system then processes the data as above with , however , the system internally tracking the data of interest . 4 . the system automatically integrates the curve from beat to beat , and outputs the stroke volume in any sort of display , having obtained the cross sectional area using the techniques mentioned in point 2 or 3 above . of course , various combinations and / or modifications of these techniques can be used if desired and depending on the particular application and / or patient . another embodiment of the present invention is in the form of hardware and / or software that exists separate from the ultrasound scanner console or workstation with means to communicate either video and / or audio and / or other signals between the ultrasound scanner and / or the display computer / system . communication between such workstation and the ultrasound scanner could include video , audio , and / or any ecg signals in digital and / or analog format . the above described processing can then be performed either partially or entirely on the workstation . in another embodiment of the present invention , the m - mode output is utilized to measure stroke volume . again , this system can comprise of hardware and / or software that resides wholly on the ultrasound scanner or can also include hardware and / or software on a separate workstation with means to communicate either digital and / or analog data with the ultrasound scanner ( fig1 and 2 ). the volume can then be estimated , as given earlier by equations 2 and 3 ( fig7 ). processing can be carried out , for example , using the following techniques : 1 . a largely manual process wherein the user measures / demarcates , either with or without the aid of an ecg , the systolic and diastolic distances between the two ventricular walls , and the system / calculating tool ( either on the ultrasound machine or on a separate computer ) calculates the stroke volume . this process can include , if desired , provisions for the user or system to record / obtain the correction factors described in equation 2 . 2 . a semi - automated process wherein the system ( either on the ultrasound machine or separate ) automatically measures the distances and estimates the stroke volume with or without the help of an ecg . in this case , the system can automatically measure / estimate the correction factors described in equation 2 , or the user can specify or aid the system in estimating / measuring these factors . 3 . a fully automated process wherein the system prompts the user to obtain particular views of the anatomy of interest and demarcate specific points and the system then processes the data as above with , however , the system internally tracking the data of interest . 4 . the system automatically measures the stroke volume , with data obtained from any of the above described methods , and outputs the stroke volume in any sort of display , having obtained the cross sectional area using the techniques mentioned in points 2 or 3 above . a yet another embodiment can include hardware and / or software separate from the ultrasound scanner , in the form of a workstation wherein there exists a mode of communication , either analog or digital , between the workstation and the ultrasound scanner or catheter . cabling from the ultrasound machine to the catheter ( especially with a multi element array catheter ) and from the catheter proximal connector to the catheter transducer housed at the distal tip can be expensive . to reduce cost , the ultrasound machine could be moved adjacent to the patient , thereby allowing a relatively short cable to be used to attach the catheter . in some cases , however , this may be impractical since most catheter rooms are sterile or semi - sterile environments and , thus , the ultrasound machine may be some distance from the patient &# 39 ; s bedside . thus , a connecting cable which is reusable ( and probable non - sterile ) is desirable , as opposed to the catheter itself , which is sterile and usually not re - usable . it would be desirable if this connecting cable could be used as a universal cable in that it could be used with many ultrasound machines . while many ultrasound machines have a standard 200 pin zip connector , most ultrasound machines do not have patient isolation means built in to the degree necessary for percutaneous catheter use . therefore , in another embodiment , the system of this invention employs a connector cable with an isolation means or isolation box that is external to the ultrasound machine itself . preferably the isolation box , which houses a plurality of isolation transformers , is relatively small so that it could be placed easily on or near the patient &# 39 ; s bed . such a cable could easily accommodate all operational communication between the catheter and the ultrasound machine and / or the appropriate computer workstation . in still another embodiment , the ultrasonic catheter further comprises a temperature sensing and / or control system . especially when used at higher power ( e . g ., when using color doppler imaging ) and / or for lengthy periods of time , it is possible that the transducer , and hence , the catheter tip , generate heat that may damage tissue . while computer software can be used to regulate the amount of power put into the catheter to keep the temperature within acceptable ranges , it is also desirable to provide a temperature sensing means as well as a safety warning and / or cut - off mechanism for an additional margin of safety . actual temperature monitoring of the catheter tip is most desirable , with feedback to the computer , with an automatic warning or shut down based upon some predetermined upper temperature limit . the system could be programed to provide a warning as the temperature increases ( e . g ., reaches 40 ° c . or higher ) and then shut off power at some upper limit ( e . g ., 43 ° c . as set out in u . s . fda safety guidelines ). to monitor the temperature at or near the tip of the catheter ( i . e ., in the region of the ultrasound transducer ), a thermistor may be used . the temperature at the tip of the catheter could be continuously monitored via appropriate software . although the software could also provide the means to control the power to the catheter in the event that excessive temperatures are generated , it would also be desirable to have a back up shut off or trip mechanism ( e . g ., a mechanical shut off or tripping means ). of course , various combinations and / or modifications of these techniques and systems can be used if desired and depending on the particular application and / or patient . it is to be understood , however , that even though numerous characteristics and advantages of the present invention have been set forth in the foregoing description , along with details of the structure and function of the invention , the disclosure is only for illustrative purposes . changes may be made in detail , especially in matters of shape , size , arrangement , and storage / communication formats within the principles of the invention to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed .

US-62051703-A

the present invention relates to an easel allowing the angle of inclination thereof to be adjusted and reliably maintaining the adjusted angle of inclination , the easel comprising : a main bracket ; expandable front supports rotatably attached on both sides of the front of the main bracket ; an expandable rear support rotatably attached to the back of the main bracket ; a supporting platform , both sides of which are detachably coupled to the front supports ; a raising - and - lowering bar attached on the front center of the main bracket so as to allow raising and lowering of same , and the lower end of which is vertically slidably supported by the supporting platform ; and a tilting unit , rotatably and expandably coupled in between the rear support and the front support platform , for controlling the angle of inclination of the rear support with respect to the front supports .

hereinafter , embodiments of the present invention will be described in detail with the accompanying drawings . fig1 and 2 are perspective views illustrating an overall structure and an operational state of an easel according to an embodiment of the present invention . as illustrated , it can be recognized that the present invention has a structure that front supports 200 and a rear support 300 are rotatably coupled to a main bracket 100 , a prop 400 is coupled to the front supports 200 , a lift 500 ascends and descends between the front supports 200 through the main bracket 100 , and a tilting unit 600 is coupled between the rear support 300 and the prop 400 to adjust a tilt angle . for reference , unexplained reference numeral 700 in fig1 and 2 denote a support clamp for stretching and fixing the front and rear supports 200 and 300 , and reference numeral 710 denotes a fixture . further , unexplained reference numeral 800 indicated by the dotted line in the main bracket 100 in fig1 and 2 denotes an upper clamp for fixing a lift position of the lift 500 after adjusting the lift position . the main bracket 100 is disposed in an upper portion of the easel according to an embodiment of the present invention to provide a rotation space of the front and rear supports 200 and 300 and a reciprocating space of the lift 500 . the front supports 200 are rotatably installed on both sides of the front of the main bracket 100 and stretchable , and support a load of painting materials such as a canvas at the front . the rear support 300 is rotatably installed in the rear of the main bracket 100 and stretchable , and distributedly supports a load of the painting materials such as a canvas together with the front supports 200 at the rear . the prop 400 is detachably coupled to the front supports 200 on both sides thereof and allows a lower edge portion of the canvas to be mounted thereon for painting materials such as a canvas to be mounted with a cross - section having a shape of “ ”, “ ”, or “ ”, providing convenience such that an operator may work . the lift 500 is installed at the center of the front side of the main bracket 100 such that it ascends and descends , and a lower end thereof is supported by the prop 400 . although not shown particularly , a fixture may be disposed at an upper end of the lift 500 to face the prop 400 , and the lift 500 may be appropriately lifted depending on the size of painting materials such as a canvas to fix the painting materials between the fixture and the prop 400 . the tilting unit 600 is rotatably and stretchably coupled between the rear support 300 and the prop 400 to adjust a tilt angle of the rear support 300 with respect to the front supports 200 . when adjustment of a tilt angle is completed , the tilting unit 600 serves to fixedly maintain a tilt angle maintenance state of the rear support 300 . in the present invention , it will be understood that the foregoing embodiment may be applied and various embodiments as follows may also be applied . as described above , it can be recognized that the tilting unit 600 adjusts a tilt angle of the rear support 300 with respect to the front supports 200 and has a structure that includes first and second auxiliary brackets 611 and 612 , first and second rotational pieces 621 and 622 , and a pivot assembly . the first auxiliary brackets 611 is coupled to the rear support 300 and connected to the first rotational piece 621 , and the second auxiliary bracket 612 is coupled to the prop 400 and connected to the second rotational piece 622 . here , the first auxiliary bracket 611 further includes a bracket fixing screw 611 ′ as shown in the enlarged part of fig2 , and an end portion of the bracket fixing screw 611 ′ is screw - coupled through the first auxiliary bracket 611 so as to be fixedly in contact with the rear support 300 , thus preventing the first auxiliary bracket 611 from running idle or moving with respect to the rear support 300 . in this case , one end portion of the first rotational piece 621 is rotatably coupled to the first auxiliary bracket 611 , and one end portion of the second rotational piece 622 is rotatably coupled to the second auxiliary bracket 612 . further , the pivot assembly connects the other end portions of the first and second rotational pieces 621 and 622 to rotate the other end portions of the first and second rotational pieces 621 and 622 such that an angle can be adjusted , various embodiments of which will be described below in more detail . also , as illustrated in the enlarged part of fig2 and fig3 , the second auxiliary bracket 612 further has a release preventing bracket 613 having a wedge shape of “ ” or “ ” fixing edges of the upper end portion of the prop 400 . further , the release preventing bracket 613 is fixed to an upper portion of the prop 400 by a fixing bolt 615 through a fixing hole 614 as illustrated in fig4 to 7 . the prop 400 will be described in detail . a plurality of adjustment holes 401 are formed at equal intervals on both sides of the prop 400 in a length direction such that the prop 400 is fixed by a bolt 701 in respective appropriate positions with the pair of front supports 200 , and a pair of fixing holes 614 are provided in a central portion of the prop 400 to fix the fixing bolt 615 . here , a lower portion of each of the adjustment holes 401 has a width greater than that of the upper portion of each of the adjustment holes 401 , and thus , a screw portion of the bolt 701 passes from the narrow upper portion and a head of the bolt 701 is fixedly in contact with the relatively wide lower edge . in contrast , an upper portion of each of the fixing holes 614 has a width greater than a lower portion of each of the fixing holes 614 , and thus , a screw portion of the fixing bolt 615 passes from the narrow lower portion and a head of the fixing bolt 614 is fixedly in contact with the relatively wide upper edge . it will be understood that structural shapes of the adjustment holes 401 and the fixing holes 614 may be variously applied and designed ; that is , conversely , the adjustment holes 401 are formed such that an upper portion thereof is wider than a lower portion thereof and the fixing holes 614 are formed such that a lower portion is wider than an upper portion thereof . when the adjustment holes 401 and the fixing holes 614 are formed to be reversed in their structural shapes as described above , the bolt 701 is pushed down so as to be fixed and the fixing bolt 614 is pushed up so as to be fixed , thus maintaining the upper and lower edges of the prop 400 in a firmly fixed state by the fixing bolt 615 and the bolt 701 together with the release preventing bracket 613 as illustrated in fig7 . then , the process of fastening the prop 400 will be described briefly as follows . first , when a user inserts the fixing bolt 615 from the wide side of the fixing hole 614 and pushes down the release preventing bracket 613 in the arrow direction as shown in fig4 , the release preventing bracket 613 pushed down together with the fixing bolt 615 comes into contact with an upper edge of the prop 400 as shown in fig5 , the fixing bolt 615 is installed , and the release preventing bracket 613 is then tightly fixed to the prop 400 . next , the user appropriately adjusts an angle of the front supports 200 , inserts a bolt 701 into the adjustment hole 401 in an appropriate position , and then pushes up the bolt 701 to install it ( in this case , the clamps 700 for supporting the rear of the support 400 ( see fig7 ) are also adjusted in position ) as shown in fig6 . then , the prop 400 is firmly tightly fixed by the upper release preventing bracket 613 , the lower bolt 701 , and the rear supporting clamps 700 as shown in fig7 . meanwhile , as shown in fig1 , 2 , and 8 , it can be recognized that the pivot assembly 630 includes a first rotary member 631 extending from the other end portion of the first rotational piece 621 , a second rotary member 632 rotating in contact with the first rotary member 631 and extending from the other end portion of the second rotational piece 622 , and a fixed piece 633 screw - coupled through the first and second rotary members 631 and 632 and having a handle formed in an end portion thereof . specifically , the user may grasp the fixed piece 633 and rotate the same in a direction opposite the screw - coupled direction to release a coupled state to allow the first and second rotary members 631 and 632 to freely rotate from each other , and then , the user may form a tilt angle of the rear support 300 with respect to the front supports 200 as desired , such as the states of fig1 and 2 , and subsequently rotate the fixed piece 633 to lock it , maintaining the tilt angle . further , as illustrated in fig9 and 10 , in the pivot assembly 640 , a tilt angle may be adjusted by a mutual contact coupling structure of contact recesses 643 and contact protrusions 644 between first and second rotary members 641 and 642 . specifically , the pivot assembly 640 includes the first rotary member 641 extending from the other end portion of the first rotational piece 621 and the second rotary member 642 rotating in contact with the first rotary member 641 and extending from the other end portion of the second rotational piece 622 . here , the hemispherical contact recesses 643 are formed at equal intervals on a contact surface of the first rotary member 641 in contact with the second rotary member 642 , and the hemispherical contact protrusions 644 are formed at equal intervals on a contact surface of the second rotary member 642 in contact with the first rotary member 641 . here , the pivot assembly 640 includes a cylinder 645 protruding from the first rotary member 641 and the second rotary member 642 and allowing rotation , separately from rotation of the first and second rotary members 631 and 632 , wherein the cylinder 645 is stretchable . this is because a spring 648 to be described later may be twisted to be damaged or deformed if the cylinder 645 rotates in conjunction with the first and second rotary members 641 and 642 . as illustrated , the cylinder 645 includes a cylinder body 646 protruding from a central portion of the first rotary member 641 and a rod 647 protruding from a central portion of the second rotary member 642 , and the rod 647 contracts or stretches in an overall length as it insertedly enters or exits the cylinder body 646 . thus , as illustrated , the cylinder 645 includes the rod 647 protruding from the second rotary member 642 with respect to the cylinder body 646 protruding from the first rotary member 641 so as to insertedly enter or exit the cylinder body 646 , and here , preferably , the cylinder body 646 and the rod 647 have flanges 646 ′ and 647 ′ to rotate with respect to the first and second rotary members 641 and 642 , respectively . here , an edge of the flange 646 ′ of the cylinder body 646 is caught by a step 641 ′ provided at an inner side of the first rotary member 641 so as to be prevented from being released , and an edge of the flange 647 ′ of the rod 647 is caught by a step 642 ′ provided at an inner side of the second rotary member 642 so as to be prevented from being released . further , it will be understood that the cylinder body 646 and the rod 647 may be modified and designed to have a reverse structure of the illustrated structure , that is , the cylinder body 646 may be provided in the second rotary member 642 and the rod 647 may be provided in the first rotary member 641 . in this case , the pivot assembly 640 includes a spring 648 having both end portions fixed to an outer circumferential surface of the cylinder 645 , i . e ., to an end portion of the cylinder body 646 and an end portion of the rod 647 , respectively , to elastically support the cylinder 645 in a contracted direction . thus , when the user wants to adjust the tilt angle of the rear support 300 with respect to the front supports 200 little by little , as illustrated in fig9 , the user may adjust the tilt angle little by little in stages by mutually rotating the first and second rotary members 641 and 642 in a mutually contacted state . further , when the user wants to significantly adjust the tilt angle of the rear support 300 with respect to the front supports 200 or wants to completely fold to be received , as illustrated in fig5 , the user may separate the second rotary member 642 from the first rotary member 641 and significantly rotate the second rotary member 642 to adjust the tilt angle . meanwhile , as illustrated in fig1 and 12 , a pivot assembly 650 may also have a ratchet structure in which sawteeth 653 and 653 ′ between first and second rotary members 651 and 652 are engaged , allowing rotation only in one direction but preventing rotation in another direction , to adjust the tilt angle and temporarily maintain a firmly fastened state . that is , the sawteeth 653 and 653 ′ are formed at equal intervals on the surface in which the first and second rotary members 651 and 652 are in contact , and sloped in one direction . further , a cylinder 654 protrudes from the first rotary member 651 and the second rotary member 652 , allows rotation separately from rotation of the first and second rotary members 651 and 652 , and is stretchable . this is because a spring 657 to be described later may be twisted to be damaged or deformed if the cylinder 654 rotates in conjunction with the first and second rotary members 651 and 652 . as illustrated , the cylinder 654 includes a cylinder body 655 protruding from a central portion of the first rotary member 651 , and a rod 656 protruding from a central portion of the second rotary member 652 , and the rod 656 contracts or stretches in an overall length as it insertedly enters or exits the cylinder body 655 . thus , as illustrated , the cylinder 654 includes the rod 656 protruding from the second rotary member 652 with respect to the cylinder body 655 protruding from the first rotary member 651 so as to insertedly enter or exit the cylinder body 655 , and here , preferably , the cylinder body 655 and the rod 656 have flanges 655 ′ and 656 ′ to rotate with respect to the first and second rotary members 651 and 652 , respectively . here , an edge of the flange 655 ′ of the cylinder body 655 is caught by a step 651 ′ provided at an inner side of the first rotary member 651 so as to be prevented from being released , and an edge of the flange 656 ′ of the rod 656 is caught by a step 652 ′ provided at an inner side of the second rotary member 652 so as to be prevented from being released . further , it will be understood that the cylinder body 655 and the rod 656 may be modified and designed to have a reverse structure of the illustrated structure , that is , the cylinder body 655 may be provided in the second rotary member 652 and the rod 656 may be provided in the first rotary member 651 . in this case , the pivot assembly 650 includes a spring 657 having both end portions fixed to an outer circumferential surface of the cylinder 654 , i . e ., to an end portion of the cylinder body 655 and an end portion of the rod 656 , respectively , to elastically support the cylinder 654 in a contracted direction . thus , when the user wants to adjust the tilt angle of the rear support 300 with respect to the front supports 200 little by little , as illustrated in fig1 , the user may rotate the first and second rotary members 651 and 652 in a mutually contacted state in mutually opposite directions to allow the sawteeth 653 and 653 ′ in mesh to slide on the sloped surfaces sloped to be lopsided in one direction , respectively , thus adjusting the tilt angle little by little in stages . further , when the user wants to significantly adjust the tilt angle of the rear support 300 with respect to the front supports 200 or wants to completely fold to be received , as illustrated in fig5 , the user may separate the second rotary member 652 form the first rotary member 651 and significantly rotate the second rotary member 652 to adjust the tilt angle . meanwhile , as illustrated in fig1 and 14 , it will be understood that a pivot assembly 670 may have a structure allowing a mutual rotational contact of first and second rotary members 671 and 672 each having contact holes 673 and contact protrusions 674 between a central shaft 675 and a bearing casing 676 . the first rotary member 671 extends from the other end portion of the first rotational piece 621 and the second rotary member 672 rotates in contact with the first rotary member 671 and extends from the other end portion of the second rotational piece 622 . the contact holes 673 penetrate through a contact surface of the first rotary member 671 in contact with the second rotary member 672 at equal intervals , and the contact protrusions 674 are formed on a contact surface of the second rotary member 672 in contact with the first rotary member 671 at equal intervals and disposed in a position corresponding to the contact holes 673 , wherein the contact protrusions 674 have a hemispherical shape . the central shaft 675 penetrates through central portions of the first and second rotary members 671 and 672 with the contact protrusions 674 in contact with the contact holes 673 , so as to be screw - coupled , and a handle 675 ′ provided in one end portion thereof is in contact with an outer side of any one of the first and second rotary members 671 and 672 . the bearing casing 676 is a container - shaped member allowing the central shaft 675 to penetrate therethrough so as to be screw - coupled , and in contact with an outer side of the remaining of the first and second rotary members 671 and 672 . a screw release preventing nut 677 is screw - coupled to the other end portion of the central shaft 675 penetrating to be exposed from the central portion of the bearing casing 676 . a spring 678 is installed in the bearing casing 676 , allows the central shaft 675 to penetrate a central portion thereof , and elastically supports the bearing casing 676 in a direction away from the first and second rotary members 671 and 672 . here , it can be recognized that the bearing casing 676 includes a container - shaped casing body 676 ′ opened toward the first and second rotary members 671 and 672 and a both - side penetrative bearing 676 ″ protruding toward the first and second rotary members 671 and 672 from the center of the casing body 676 ′ and having a thread formed on an inner circumferential surface thereof to allow the central shaft 675 to penetrate and be screw - coupled therein . in this case , the spring 678 is disposed between an outer circumferential surface of the bearing 676 ″ and an inner circumferential surface of the casing body 676 ′. thus , when the user wants to adjust a tilt angle of the rear support 300 with respect to the front supports 200 little by little , the user may rotate the handle 675 ′ in a direction in which the central shaft 675 is released with respect to the screw release preventing nut 677 in a state in which the first and second rotary members 671 and 672 are in contact , to release the tightly attached state of the first and second rotary members 671 and 672 to form a small gap therebetween . in this case , even though the first and second rotary members 671 and 672 are allowed to have a gap therebetween , the first and second rotary members 671 and 672 are maintained in a mutually tightly attached state due to elastic repulsive power of the spring 678 . thereafter , when the user rotates the first and second rotary members 671 and 672 in mutually opposite directions , the contact protrusions 674 insertedly positioned in the contact holes 673 are inserted into other contact holes 673 spaced apart by a predetermined interval in stages , thereby adjusting the tilt angle little by little . meanwhile , even in a state in which the tilt angle is adjusted by the pivot assemblies 630 , 640 , and 650 of the tilting unit 600 according to various embodiments described above , the tilt angle of the rear support 300 needs to be more finely adjusted with respect to the front supports 200 . thus , the tilting unit 600 may have a structure allowing third and fourth rotational pieces 603 and 604 to enter and exit first and second container bodies 661 and 662 extending to both sides based on the pivot assembly 630 , 640 , or 650 as illustrated in fig1 ( in fig5 , it will be understood that the pivot assembly 630 of fig8 is applied , and the pivot assemblies 640 and 650 according to the other embodiments may also be applied ). that is , the tilting unit 600 includes the third rotational piece 603 rotatably coupled to the rear support 300 and the fourth rotational piece 604 rotatably coupled to the prop 400 . further , the tilting unit 600 includes the first container body 661 forming an internal space in which the third rotational piece 603 is accommodated and coupled such that it enters and exits , and the second container body 662 forming an internal space in which the fourth rotational piece 604 is accommodated and coupled such that it enters and exits . thus , the pivot assembly 630 connects the end portions of the first and second container bodies 661 and 662 and rotates the end portions of the first and second container bodies 661 and 662 to adjust an angle . in addition , the tilting unit 660 further includes positioning pins 663 and 664 penetratingly coupled to the first and second container bodies 661 and 662 , respectively , and positioning recesses 605 and 606 formed at equal intervals on one edges of the third and fourth rotational pieces 603 and 604 and having a shape corresponding to an outer circumferential surface of the positioning pins 663 and 664 . thus , the tilting unit 600 allows the third and fourth rotational pieces 603 and 604 to enter and exit in a length direction of the first and second container bodies 661 and 662 , respectively , thus finely adjusting the tilt angle of the rear support 300 with respect to the front supports 200 . as described above , according to the present invention , the easel enabling a tilt angle to be adjusted as desired and reliably maintain an adjusted tilt angle can be provided . according to the present invention having the configuration as described above , a stable structure can be obtained by the tilting unit which is rotatably and stretchably coupled between the rear support and the prop , adjusts a tilt angle of the rear support with respect to the front supports according to various embodiments such as the contact recesses and the contact protrusions or the sawteeth structure , and maintains an adjusted tilt state . while the invention has been shown and described with respect to the embodiments , the present invention is not limited thereto . it will be understood by those skilled in the art that various changes and modifications may be made without departing from the scope of the invention as defined in the following claims .

US-201314398457-A

an imaging tomography apparatus with multiple operating modes has at least two radiators from which x - ray radiation emanates . the tomography apparatus has a radiation detector arrangement with a first detector and a second detector . at least the first detector can be reversibly moved relative to the second detector along a circumferential track of the measurement device of the gantry .

the inventive computed tomography apparatus in a first measurement position is shown in fig1 . a gantry ( designated with the reference character 1 ) of the apparatus has a stationary part 2 and a part 3 that can rotate around a fixed z - axis z . a first x - ray tube 4 and a second x - ray tube 5 are mounted on the rotatable part 3 offset from one another by an angle of approximately 90 ° with regard to the z - axis z . a diaphragm mounted on the first x - ray tube 4 , with a variable first diaphragm aperture b 1 , is designated with the reference character 6 . a fan - shaped x - ray beam 7 with an aperture angle α originates from the first x - ray tube 4 . a detector arrangement 8 is located on the rotatable part 3 of the gantry 1 in the beam path of the first x - ray beam 7 opposite the first x - ray tube 4 . the detector means 8 has a first detector 9 and a second detector 10 disposed adjacent to one another . the first detector 9 and the second detector 10 are connected with flexible lines 11 with a data acquisition unit 12 . a field of view with a diameter d , situated in the beam path of the first x - ray beam 7 , is designated with the reference character 13 . the fan - shaped x - ray beam 7 emanates from the first x - ray tube 4 in the operation of the x - ray computed tomography apparatus . the x - ray tube 5 is inoperative . to detect the x - ray beam 7 , the first detector 9 and the second detector 10 are arranged next to one another in its beam path . they form an essentially contiguous detection surface azimuthally curved with regard to the z - axis z . each detector 9 or and 10 has one or more ( lying in series ) detector rows in the direction of the z - axis z . all channels of the first detector 9 and the second detector 10 are used to detect the x - ray radiation 7 . this is possible with an aperture angle of , for example , α = 52 ° suitably set by the diaphragm 6 . the diameter d of the field of view 13 is maximum at this aperture angle . the diameter d of , for example , 499 mm corresponds to that of a field of view of a conventional x - ray computed tomography apparatus . the apparatus of fig1 can be operated as such a conventional x - ray computed tomography apparatus in the operating mode . for acquisition and further processing of the data , the first detector 9 and the second detector 10 share a common data acquisition unit 12 . this synchronizes the data acquired by the detectors 9 and 10 and combines these in a correct sequence . the data acquisition unit 12 forwards the data to a transfer device ( not shown ) that transfers the data from the rotatable part 3 of the gantry 1 to the stationary part 2 of the gantry . fig2 schematically illustrates the changing of the positions of the first detector 9 and second detector 10 . the first x - ray tube 4 and the second x - ray tube 5 are disposed as in fig1 , offset by approximately 90 °. the positions of the first detector 9 and second detector 10 of fig1 is shown only for explanation . the diaphragm 6 with a second diaphragm aperture b 2 and the second detector 10 are located in succession in the beam path of the first x - ray beam 7 emanating from the first x - ray tube 4 with a second aperture angle α 2 . a second diaphragm 14 with the fixed second diaphragm aperture b 2 and the second detector 9 are located in succession in a beam path of a second x - ray beam 15 emanating from the first x - ray tube 5 with a second aperture angle α 2 . position changes of the first detector 9 and second detector 10 relative to the position ( shown in fig1 ) are shown with the reference characters 16 and 17 . the position changes of the first detector 9 and second detector 10 ensue as follows : the first detector 9 and the second detector 10 are positioned by means of electromechanical actuators ( not shown ). the actuators are connected to a control system ( not shown ) of the gantry 1 and are controlled by software for the positioning , the first detector 9 is rotated ( moved on the track ) clockwise by the angle 90 − α 2 / 2 degrees relative to the z - axis z . the first detector 9 is subsequently rotated clockwise around an axis running through the detector and thus aligned to the focal spot of the second x - ray tube 5 . the second detector 10 is rotated clockwise by the angle α 2 / 2 degrees around a rotation axis running through the focal spot of the first x - ray tube 4 and parallel to the z - axis z . the second detector 10 is thereby aligned to the focal spot of the first x - ray tube 4 . the diaphragm apertures b 2 of the diaphragms 6 and 14 are selected such that the x - ray beams 7 and 15 respectively emanating from the first x - ray tube 4 and the second x - ray tube 5 are entirely detected by the second detector 10 and the first detector 9 , respectively . a second measurement position is shown in fig3 . the arrangement of the first x - ray tube 4 and second x - ray tube 5 as well as the position of the first detector 9 and second detector 10 correspond to those in fig2 . the first detector 9 and the second detector 10 are connected with the data acquisition unit 12 with the flexible line 11 . this data acquisition unit 12 is located between the two detectors 9 and 10 . a common field of view 16 has a second diameter d 2 , and is situated in the beam paths of the first x - ray beam 7 and the second x - ray beam 15 . after the positioning ( as described in fig2 ) of the first detector 9 and second detector 10 , these are aligned to the focal spots of the second x - ray tube 5 and the first x - ray tube 4 , respectively . the optical axes of the first x - ray tube 4 and of the second detector 10 , and of the second x - ray tube 5 and the first detector 9 , intersect in the region of the z - axis z and are essentially perpendicular to one another . the second detector 10 detects the x - ray beam 7 emanating from the first x - ray tube 4 . the first detector 9 detects the x - ray beam 15 emanating from the second x - ray tube 5 . the size of the field of view 16 is smaller in comparison with the field of view 13 of fig1 . the field of view 16 is established by the azimuthal expansion ( dimension ) of the first detector 9 and second detector 10 as well as by the aperture angle α 2 . with an aperture angle of , for example , 26 degrees , it is possible to achieve a second field of view 16 with a second diameter d 2 of approximately 256 mm . this is sufficient in order to use the x - ray computed tomography apparatus for imaging of heart . the first detector 9 and second detector 10 are connected with the common data acquisition unit 12 via flexible cables . it is thereby possible to move the first detector 9 and the second detector 10 relative to the data acquisition unit 12 . the data acquisition unit 12 processes the data and prepares the transfer of the data from the rotatable part 3 of the gantry 1 to the stationary part 2 of the gantry 1 . fig4 shows a measurement arrangement analogous to fig3 , with a second detector arrangement 21 formed of a first flat detector 19 and a second flat detector 20 . the first and second detectors 9 , 10 shown in fig1 through fig3 with azimuthally curved detector surfaces are replaced by flat detectors . the functioning as well as the positioning of the first flat detector 19 and the second flat detector 20 are analogous to those explained in connection with fig1 through fig3 . although modifications and changes may be suggested by those skilled in the art , it is the intention of the inventor to embody within the patent warranted hereon all changes and modifications as reasonably and properly come within the scope of his contribution to the art .

US-14876905-A

the invention provides a frozen product of boiled noodles of japanese buckwheat , which has an improved feel in eating and can sustain the improved feel in eating for a long term , and a chilled or frozen product of raw noodles of japanese buckwheat , which has an improved feel in eating when boiled and can sustain the improved feel in eating for a long term . the frozen product of raw or boiled noodles of japanese buckwheat employs , as dough materials , a mixture of at least gluten , partially decomposed substances of wheat protein , an edible oxidant and / or an edible reductant , and trehalose . more specifically , the noodles contain , as dough materials , 90 - 30 weight parts of buckwheat flour , 10 - 65 weight parts of wheat flour , 0 . 5 - 5 weight parts of gluten , 0 . 5 - 5 weight parts of an edible oxidant and / or an edible reductant , 0 . 5 - 5 weight parts of partially decomposed substances of wheat protein , and 0 . 5 - 5 weight parts of trehalose . the frozen product of boiled noodles of japanese buckwheat is adaptable for microwave cooking .

the present invention has succeeded in achieving the above objects by adding , to main materials of noodles , various quality improving agents described below . trehalose used in the present invention is a non - reducing disaccharide consisted of two glucose molecules . the origin , the manufacturing method , etc . of trehalose are not limited to particular ones in achieving the objects of the present invention . trehalose is required to , in mixing of noodle dough , stably obtain the optimum dough condition without loosing a proper elasticity of the dough . though detailed mechanism of the action is not yet clarified , trehalose serves as a food ingredient effective to not only realize the optimum moisture adjusting function based on water retention of wheat gluten ( protein ) and free water generated in the dough , but also prevent surface degradation in freezing , dripping , reduction of flavor , aging of starch , degeneration of protein , etc . further , the noticeable effect of improving the resistance against mixing can be obtained by adding trehalose of preferably not less than 0 . 5 weight part with respect to a total ( 100 weight parts ) of buckwheat flour and wheat flour as main materials for the noodle dough . in other words , trehalose can be added in such a range as not adversely affecting the process of producing soba . of proteins contained in grains such as wheat , corn and soybean , the protein of wheat contains glutenin and gliadin as main components , and it is usually called wheat gluten . the protein of corn contains zein as a main component , and it is usually called corn gluten . those proteins are known substances and can be obtained from grains through the separation or extraction process based on the ordinary method . the wheat gluten can be employed as any of raw gluten , powdery active gluten , and denatured gluten . raw gluten is obtained by washing wheat flour with water and separating water - insoluble protein in the wheat flour . the raw gluten may be in the viscous massive form as obtained just after the above steps , but it is preferably added in the form of powder , which is obtained by drying and pulverizing the viscous massive gluten , for preparing a homogeneous composition . powdery active gluten is obtained by drying and pulverizing the raw gluten with , e . g ., freeze drying or spray drying , so that thermal degeneration of gluten is minimized . denatured gluten is obtained by treating the raw gluten or the active gluten with an acid , alkali , oxidant or a reductant to such an extent that gluten will not undergo changes of chemical properties , in particular , decomposition , and then drying and pulverizing the treated gluten . partially decomposed substances of gluten are obtained by subjecting the grain protein to a decomposition process employing one or a combination of two or more selected from among treatments with an acid , alkali , oxidant and a reductant . one practically usable method for preparing the partially decomposed substances of wheat protein is disclosed in , for example , japanese patent laid - open publication no . 1 - 127032 . one example preferably employed in the present invention is “ glupal 653 ( trade name )” ( made by k . k . katayama chemical mfg . research in japan ) that is prepared by mixing food fibers in partially decomposed substances of wheat protein , which is obtained by heating wheat protein with addition of an acid and then heating it with addition of an alkali , and that is marketed as a noodle improving agent effective in providing a proper elasticity and preventing the noodles from loosing stiffness while they are dipped in hot water or boiled . for ensuring the effect of improving the noodle quality , a mixing ratio of the partially decomposed substances of wheat protein and the wheat gluten is preferably set such that the wheat gluten is in the range of 0 . 3 to 5 weight parts with respect to 1 weight part of the partially decomposed substances of wheat protein . also , in general , quality improving agents containing , as effective components , the partially decomposed substances of wheat protein and the wheat gluten are each preferably added in the range of 0 . 1 to 7 weight parts , more preferably in the range of 0 . 5 to 5 weight parts , to total 100 weight parts of soba flour and wheat flour in the noodles . if the amount by which the partially decomposed substances of wheat protein and the wheat gluten are each added is less than the lower limit , the effect of improving the noodle quality would be insufficient , and if the amount exceeds the upper limit , a further improvement in the effect corresponding to an increased of the amount added would not be expected . an oxidant used as an additive to the noodle dough serves a compound for depriving s — h of (— h ) in the cross - linking reaction of gluten . examples of the usable oxidant include dehydroascorbic acid ( oxidation type vitamin c ) and ascorbate oxidase that is an enzyme for producing oxidation type vitamin c . a reductant used as an additive to the noodle dough serves a compound for giving s — s with (— h ) in the cross - linking reaction of gluten . examples of the usable reducant include cystine hydrochloride ( l - cystine ) and ascorbate na . in the s — h and s — s substitution reactions , the noodle dough is softened using a reductant , and thereafter strong binding is produced in the noodle dough by maximally utilizing the s — s bond based on the effect of an oxidant . one preferable example of the noodle production improving agent having such a function is “ lsupport noodle a ( trade name )” ( made by okumoto milling k . k .) that contains wheat flour , ascorbate na , and l - cystine . the quality improving effect obtained by the present invention is achieved only when gluten , an edible oxidant and / or an edible reductant , partially decomposed substances of wheat protein , and trehalose are combined with each other at a predetermined mixing ratio . though detailed action produced by those components is not yet clarified , it is deemed that the unique action is developed with mixing of the four components . noodles to which the present invention is applied are ones of japanese buckwheat ( soba ) which are preserved in the frozen state while being raw or after boiling . a manner of boiling the noodles is not limited to a particular one , and the boiled noodles can be obtained from raw noodles , frozen raw noodles , half - dried noodles , and dried noodles by a conventional boiling method . the above - described additives can be added to the main materials of the noodles beforehand . alternatively , it is also possible to disperse the additives in water under preparation , and to add the water containing the additives to the main materials . after thus adding the additives to the main materials , noodles of japanese buckwheat ( soba ) are prepared from the mixed materials . so long as the effect intended by the present invention is not impaired , other additives than the above - described components can also be added , which include , e . g ., an emulsifier ( such as glycerin fatty acid ester , sucrose ( cane sugar ) fatty acid ester , polyglycerin fatty acid ester , or propyleneglycol fatty acid ester ), a viscosity - increasing stabilizer ( xanthane gum , guar gum , carrageenan , or alginic acid ), startch and processed starch having been subjected to , e . g ., hydrolysis , an anticeptic , a colorant , and spices . it is however desired that those other additives be not employed as far as possible . a method for producing the frozen product of raw noodles of japanese buckwheat ( soba ) according to the present invention will be described below in brief . the frozen product of raw noodles of japanese buckwheat ( soba ) is produced using a material composition shown in table 1 under conditions shown in table 2 . for reference , a manner of cooking the raw noodles is also briefly stated in table 2 . [ 0029 ] table 2 water proper amount depending on production method . ( 25 - 52 % to total of the above - stated materials ) others if needed from production purpose , salt , alcohol and other additives can be added . production method mixing → pressing ( kneading ) → stretching → ( manual ) cutting → freezing production method mixing → plain noodle strips → combining → ( mechanical rolling ) stretching → cutting → freezing cooking boiling → stiffening in ice water → dishing - up ( for reference ) the frozen product of boiled noodles of japanese buckwheat ( soba ) is produced using a material composition shown in table 1 under conditions shown in table 3 . for reference , a manner of cooking the frozen product of the boiled noodles is also briefly stated in table 3 . the present invention will be described in more detail in connection with examples . it is to be noted that the present invention is in no way limited by the following examples . raw noodles of japanese buckwheat ( soba ) were produced by using a material composition shown in table 4 under conditions shown in table 5 . one half of the produced noodles were packed per meal in a freezing - resistant bag made of a synthetic resin and preserved at − 11 ° c . for 16 days . the other half was boiled for 40 seconds and then quickly cooled and washed with cold water ( ice water ). the cooled noodles were packed per meal and quickly frozen using a quick chiller , followed by preservation in the frozen state at − 11 ° c . for 16 days . when tasting the noodle products , the frozen product of raw noodles was boiled for 40 seconds , quickly cooled and washed with cold water ( ice water ), and then dished up on a bamboo basket . the frozen product of boiled noodles was thawed for 2 minutes and 30 seconds per meal in a microwave oven , quickly cooled and washed with cold water ( ice water ), and then dished up on a bamboo basket . the taste of the soba thus prepared was evaluated ( as sensory tests ) in five stages ( a to e ). as a result , both the products were rated as a ( good ). [ 0037 ] table 5 step mixing 5 minutes dividing dough is divided in units of 2 - 3 kg pressing manual kneading stretching repeat rolling in lengthwise and widthwise directions alternately from 1 - stage rolling . sprinkle flour during rolling . use rods for rolling from the middle and pass dough lengthwise . finish to about 1 . 6 - mm thickness . cutting cutting at width of about 2 . 5 mm sensory tests were conducted to confirm which one of materials affects the taste and the feel in eating . table 6 shows results of the sensory tests . raw noodles of japanese buckwheat ( soba ) were produced in a similar manner to that in example 1 . the produced raw noodles were boiled for 40 seconds and then quickly cooled and washed with cold water ( ice water ). the cooled noodles were packed per meal and quickly frozen using a quick chiller , followed by preservation in the frozen state at − 11 ° c . for 16 days . when tasting the noodle product , the frozen noodles were thawed for 2 minutes and 30 seconds per meal in a microwave oven , quickly cooled and washed with cold water ( ice water ), and then dished up on a bamboo basket . the evaluation of the taste and the feel in eating by the sensory tests was rated in five stages ( a to e ). as described above , the present invention can provide a frozen product of boiled noodles of japanese buckwheat ( soba ), which has an improved feel in eating and can sustain the improved feel in eating for a long term . also , the present invention can provide a chilled or frozen product of raw noodles of japanese buckwheat ( soba ), which has an improved feel in eating when boiled and can sustain the improved feel in eating for a long term .

US-28566802-A

a composition is provided comprising extracts of at least grape seeds and green tea . the extracts are preferably polyphenolic and preferably comprises probiotic bacteria . the use of extracts from green tea and grape seeds for the manufacture of a medicament against a neurodegenerative disease is also disclosed .

before explaining at least one embodiment of the invention in detail , it is to be understood that the invention is not necessarily limited in its application to the details set forth in the following description . the invention is capable of other embodiments or of being practiced or carried out in various ways . the terms “ comprises ”, “ comprising ”, “ includes ”, “ including ”, and “ having ” together with their conjugates mean “ including but not limited to ”. the term “ consisting of ” has the same meaning as “ including and limited to ”. the term “ consisting essentially of ” means that the composition , method or structure may include additional ingredients , steps and / or parts , but only if the additional ingredients , steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition , method or structure . as used herein , the singular form “ a ”, “ an ” and “ the ” include plural references unless the context clearly dictates otherwise . for example , the term “ a compound ” or “ at least one compound ” may include a plurality of compounds , including mixtures thereof . it is appreciated that certain features of the invention , which are , for clarity , described in the context of separate embodiments , may also be provided in combination in a single embodiment . conversely , various features of the invention , which are , for brevity , described in the context of a single embodiment , may also be provided separately or in any suitable sub - combination or as suitable in any other described embodiment of the invention . certain features described in the context of various embodiments are not to be considered essential features of those embodiments , unless the embodiment is inoperative without those elements . unless otherwise defined , all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs . although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention , suitable methods and materials are described below . in case of conflict , the patent specification , including definitions , will control . in addition , the materials and methods are illustrative only and not intended to be limiting . no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention , the description making apparent to those skilled in the art how the several forms of the invention may be embodied in practice . preparations and applications of medicaments comprising at least two of egcg , gse and l . plantarum are provided , that , surprisingly synergistically improve mental abilities such as memory and are thus thought to also inhibit or at least reduce the progression of diseases such as alzheimer disease or pd . preferably , the medicament comprises at least egcg and gse . meganatural - bp ® is 300 mg gse provided in hpmc ( hydroxypropylmethyl cellulose ) capsules ( dr caps ®) of capsugel , which are gastric - resistant and mostly disintegrate in the small intestine . egcg ( lyan , china ) and lactobacillus plantarum r1012 - 150 ( institut rosell , canada ) dr caps capsules were prepared . the average amount of lactobacillus plantarum per capsule was 377 mg / capsule ( about 6 * 10 10 bacteria ). the bacteria should be kept in cool conditions — about 5 ° c . the average amount of egcg was 218 mg . the egcg is produced by water / etoh extraction from leaves of locally cultivated camellia sinensis o . ktze . the catechins content in the egcg is preferably at least 95 %. the content of polyphenols in gse is preferably at least 90 %. green tea and grape seed extracts as well as bacteria from other suppliers are considered to have an effect similar to that from these material sources . the minimum effective dosage of gse per day is considered to be about 100 mg , and the minimum effective dosage of egcg is about 50 mg per day ; the dosage depends upon the severity of the condition and the patient &# 39 ; s general state of health , as well as weight and other considerations familiar to the practitioner . it is notable that although full clinical trials involve control by placebo , the preliminary results from treatment of a patient suffering from ad , described below , are absent this control . however , such control is perhaps of little relevance since , to the best of the inventors &# 39 ; knowledge no reliable and perceptible change would be observed in administration of placebos to such patients having cognitive impairment . since the polyphenols generally react with proteins , the administration is best performed on an empty stomach . a first subject consumed a capsule containing 300 mg of meganatural - bp ® over a period of 18 months , once daily , immediately after nocturnal sleep . some improvement of memory was observed during the period that the gse was administered , compared to memory ability before the administration commenced . general effect of egcg on mental faculties the same subject ceased to consume gse and immediately subsequent consumed capsules of 100 mg egcg ( lyan ) over a period of 40 days , once daily , immediately after nocturnal sleep . no improvement of memory was observed during the period that the egcg was administered . 300 mg of meganatural - bp ® and 60 mg of egcg capsules were concomitantly administered to the same subject , immediately after nocturnal sleep , following the egcg regime . there was a pronounced improvement of long - term memory which had not been previously observed by an observation group as well as by the subject . the improvements were both in the level of detail and in the completeness of the memory . for example , location / people details of a family trip were recalled that no other members of the family nor indeed the subject himself could previously recall ; details of an artwork observed over 40 years previously by the subject and a group of people were recalled in minute details , including the location of the creation , shape and its colors , whereas none of the members of the group could recall any of these details . the subject also reported feeling generally physically well and more lucid in mind . it is noteworthy that three months into the combined gse and egcg regime , the subject was found to have below normal levels of folic acid . it is known that there is a positive correlation between folic acid and memory , thus the apparent improvement in memory may be despite folic acid deficiency . a hypertensive and diabetic 82 year old male exhibited a cognitive deterioration and subsequently ( after about a year ) underwent mini - mental state examination ( mmse ) which produced a grade of 13 ; thus the patient was diagnosed as suffering from alzheimer disease . six weeks after the diagnosis , the patient &# 39 ; s condition continued to deteriorate . the patient was administered memantine hydrochloride ( ebixa ® tablet ), an antidementia medicine , on a daily basis . blood - pressure reducing medication was concomitantly administered and the blood pressure was measured to be on the average of 130 / 70 systolic / diastolic . however , the patient &# 39 ; s deterioration appeared to be unaffected by the drug and administration of ebixa was consequently discontinued after two weeks . the following four months were characterized by sporadic memory lapses typical of a moderately severe affliction as well as behavioral deteriorations that occurred from time to time at this point of time , according to a 60 days plan , the patient was daily administered two meganatural - bp ® capsules ( 600 mg ), one 218 mg egcg capsule ( lyan ) and one l . plantarum capsule ( 377 mg ), as well as blood - pressure reducing medication . about 18 days after the administration ( of the gse . egcg , and bacteria ) was initiated , the blood pressure dropped to about 70 - 80 / 50 . consequently , the blood - pressure reducing medication was discontinued and the administration of gse was reduced to one capsule per day ( 300 mg ) as gse is known to reduce blood pressure . two weeks ( 14 days ) thereafter the reduction of blood pressure , the deterioration appeared to have halted . during the next two weeks , a gradual improvement of the mental capacities such as memory - related performance was observed . in the next two weeks , a significant improvement in the cognitive state of the patient was observed and his mental state started to become more stable . regression of the disease was noted . at this point , the gse , egcg , and bacteria were discontinued and the patient &# 39 ; s mental capacities appeared to have dramatically improved compared to his condition just prior to the administration of the gse , egcg and probiotic bacteria , in particular his ability to follow a clock and sense time appeared to have been restored and there were no memory lapses . no adverse effects on blood sugar were observed during and after the treatment . slight memory lapses were observed subsequent to the discontinuation , and a repeat mmse performed 3 weeks later gave a grade of 19 , which is still a highly significant improvement over the patient &# 39 ; s performance in the mmse prior to the administration of gse , egcg , and bacteria . it should be mentioned that cipralex ®, a drug against depression and anxiety , as well as other calming drugs were administrated to the patient prior and during the administration of the gse , egcg , and bacteria according to need . the gse may be the extract described in any of the patents u . s . pat . no . 7 , 767 , 235 , u . s . pat . nos . 7 , 651 , 707 and 6 , 544 , 581 , and may be prepared according to the process described in u . s . pat . no . 8 , 075 , 929 ; however , other similar preparations and processes may be investigated whether they contribute to a similar synergistic effect , for example more particular ingredients of the gse may be used . the capsules may comprise both the bacteria and the gse and / or egcg ; having all the components together may simplify the medication regime ; however , it may be that the gse and / or egcg reduce the effectiveness of the medication , presumably due to an adverse interaction of substances in the gse / egcg with the bacteria . therefore , in some embodiments the bacteria are separately provided in gastric - resistant capsules or other dosage forms . in other embodiments the bacteria and / or gse / egcg extracts ( either or both ) are enteric coated , and are provided as enteric - coated granules within one dose , e . g . capsule . presumably the bacteria perform most of their beneficial activity in the large intestine ; and most of the bacteria are likely to arrive there intact when protected from the gastric conditions in the stomach . alternatively , the bacteria and the polyphenols may be provided in separate compartments . such segmented capsules / pills may be manufactured by 3 - d printing for example , with the materials therein , or added after the pill / capsule is ready . other forms of delivery may be used instead of or in addition to capsules , including but not limited to nutraceuticals , tablets , suspensions , suppositories ( liquid or solid ), injectable / intravenous solutions and lotions . the solid forms of delivery may be at least partially 3 - d printed . some embodiments further comprise flavourings and / or food stuff , to help consume the materials . the foodstuff is preferably low - protein . in some embodiments the bacteria are physically separated or functionally isolated from the egcg and gse extracts until they all arrive at the intestines ; or at least they remain as separate as possible until arrival at the large intestine . polysaccharide coating of the gse , egcg and bacteria , or at least the bacteria , may help delay the interaction until the optimal time . surprising synergy of the ( presumably polyphenolic ) ingredients in grape seed and green tea extracts has been demonstrated for improvement of mental condition or at least helping to reduce mental deterioration , in particular when properly used in conjuction with probiotic bacteria that are thought ( without being bound to the theory ) to provide metabolic products with improved efficacy . other synergies that are considered likeliest are between the gse and / or green - tea egcg and polyphenolic extracts from other plant sources , in particular from pomegranates , dates , and various berries or vitamin e . other oxidants or polyphenols can be used without limiting the scope of the invention . although the invention has been described in conjunction with specific embodiments thereof , it is evident that many alternatives , modifications and variations will be apparent to those skilled in the art . accordingly , it is intended to embrace all such alternatives , modifications and variations that fall within the spirit and broad scope of the appended claims . all publications , patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification , to the same extent as if each individual publication , patent or patent application was specifically and individually indicated to be incorporated herein by reference . in addition , citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention . 3 ) weinreb o . et al . j . nutritional biochemistry 15 ( 9 ) 506 - 516 ) ( 2004 ) 4 ) ehrnhoefer , d . e . et al . nature structural & amp ; molecular biology 15 ( 6 ) 558 - 566 ( 2008 ). 5 ) rezai - zadeh , k . et al . j . of neoroscience 25 , 8807 - 8814 ( 2005 ). 6 ) kuriyama s . et al . am . j . clinical nutrition 83 ( 2 ), 355 - 361 ( 2006 ). 9 ) a brochure on meganatural - bp a patented grape seed extract . published by polyphenolics , p . o . box 99 , madera calif . 93639 ( www . polyphenolics . com ) 10 ) sivapraksapillai , b . et al . metabolism clinical and experimental 58 , 1743 - 1746 ( 2009 ). 11 ) wang , j . et al . the journal of neuroscience 28 ( 25 ), 6388 - 6392 , ( 2008 ).

US-201414776170-A

a method of employing a gaze direction tracking system for control of a computer comprises the steps of : providing a computer display incorporating a screen and at least one off - screen control target ; and eye - pointing by a user at the control target . the eye - pointing is detected by the gaze control tracking system so as to effect a predetermined control action in the computer .

the computer display 1 shown in fig1 incorporates four light emitting diodes ( leds ) arranged at the top of a screen together with a gaze direction tracking camera 5 located at the bottom of the screen . the state of illumination and / or colour of the leds provides feedback on the status of a gaze direction control system . the off - screen controls provide the user with control over the gaze direction tracker . for example , an led 2 at the top left - centre of the display is normally red to signify the system is disengaged and the user can then view the display on the screen without any further actions occurring . on gazing at the led 2 , it turns green to indicate the system is engaged and will respond to the user eye - pointing to a target on the screen . when the user gazes once again at the led 2 while it is green , the system is disengaged and the led reverts to red . alternatively or additionally , the green led may revert to red and the system may be disengaged once an action has been selected by eye - pointing as will be described hereinafter or after a predetermined time - out period . the led is therefore used as a target for engaging the gaze direction tracking system and is located a sufficient distance ( for example , about 30 to 50 mm ) outside the edge of the computer &# 39 ; s screen to avoid inadvertent triggering when viewing items on the screen . the led target is also determined by the system to have a relatively large target area , such as a square of 25 to 30 mm by 25 to 30 mm , to make engagement of the system a simple operation not requiring precise eye - pointing . of course the size and shape of the target area may be different if desired . the system is then engaged by gazing at the target area for a predetermined time , for example about a quarter to half a second , whereupon the system is engaged and remains active until either it is positively disengaged by the user or there is no relevant activity for a predetermined time . additional leds may be provided to offer further functionality , for example when used with disabilities - focussed software which provides the user with access to text , photographs , music and typing , using multiple grids of options , that is menus . for example , when reading an on - screen text , eye - pointing at led 4 may be used to “ turn the page ” and looking at led 1 may be used to “ turn back a page ”. leds 1 and 4 , which are positioned at opposite sides of the top of the display , may have alternative functions with different aspects of the software . for example , when listening to music led 4 may move to the next track , while led 1 may return to the previous track . as a further alternative , leds 1 and 4 may be used to the previous or to the next menu of options . the leds themselves may be switched to on to indicate when they are active and to off to indicate when they are inactive . led 3 , at the top right - centre of the display , may enable the user to return to a specific point in the software , such as the “ home page ” of the disabilities - focussed software . the leds may be colour coded to assist the user in identifying their different functions . for example , leds 1 and 4 may be illuminated amber to indicate moving to another display , while led 3 may be illuminated blue to indicate resetting the software to the “ home page ”. switches ( not shown ) may be associated with each led to enable the user , or an assistant , to operate the controls manually . once the system has been engaged , the user eye - points to a desired location on the screen . the result of this is shown in one embodiment in fig2 . the conventional system cursor is shown at the ( known ) location where the gaze tracking system calculates the point of gaze to be , with inherent inaccuracies , and also a ‘ dot ’ which is offset from , but near to , the cursor . the user then re - directs his gaze at the ‘ dot ’ which allows the gaze tracking system to acquire the data it needs to calibrate itself . the system cursor and the ‘ dot ’ are removed from the screen and are replaced at the location of eye - pointing as determined from the new data either in the form of the system cursor or as an alternative cursor , such as a cross - hair cursor . the absolute accuracy of eye - pointing can be enhanced as described above by applying a positional correction based on the measured data obtained when the user is directing his or her gaze at a known location . the use of a one - off calibration procedure of this type is well - known with gaze direction tracking . the first time a user uses the gaze direction tracker , the system is calibrated for that user , with the user looking at one or more on - screen targets of known location . according to an aspect of the present invention , an alternative or additional dynamic calibration procedure takes place while the user is using the system in order to further enhance the accuracy of eye - pointing . that is , the present invention takes advantage of the fact that the user frequently directs his or her eyes at locations of known position ( a known target ), such as the ‘ dot ’ in fig2 or the controls of fig3 which are additional to those of fig1 and 2 . in fig3 , a graphical display is provided on the screen with a central cross - hair cursor surrounded by eight squares containing controls , such as arrows to indicate a desired direction of cursor movement and indicia , such as l , r , d and drop for indication mouse control actions such as left click , right click , double click , and drag and drop the controls are provided at predetermined locations on the screen and are therefore known targets . selection of any of these controls provides events which in turn provide calibration data which can be used to enhance the accuracy of eye - pointing to a predetermined target of unknown location ( an unknown target ). it is also possible to use the off - screen controls , but accuracy may not be as good because of the greater separation from on - screen targets . such a dynamic calibration procedure significantly enhances the accuracy of eye - pointing because it takes place locally both in time and space . that is , it typically occurs only a few seconds before a selection is made , during which time the user &# 39 ; s eye position and condition of tear fluid will have changed very little . ideally , dynamic calibration should be effected as soon as possible before a selection is made , most preferably within less than one second , and as close as possible to the location of the selected target , most preferably less than 40 mm . in practice , the time between eye - pointing to an unknown target and then eye - pointing to a known target will be a few seconds , typically less than two seconds , and provides a significant dynamic enhancement in accuracy compared with a conventional calibration procedure which will have been undertaken a considerable time , possibly even days , before . in practice , dynamic calibration also occurs relatively close to the location of the unknown target on the screen . in this way , the user makes only a small movement of head or eyes when moving from the known target to the unknown target . the spatial separation between the known target and the unknown target is ideally less than 100 mm and preferably less than about 50 mm . the or each known target may be provided on the computer screen , such as one or more of the on - screen controls . alternatively , the or each known target may be located remotely from the screen , such as offset below the lower edge of the screen or offset above the upper edge of the screen , although the spatial separation between the known target and the unknown target will be somewhat greater . error correction may be employed , for example , as a number of pixels in the x and y directions . then if the user is required to gaze at a target having actual pixel co - ordinates of x and y , then the gaze direction tracking system will return a measured position of x ± δx and y ± δy . subsequently the user eye - points to a desired unknown target having co - ordinates of x and y , the gaze direction tracker will return a measured position of x ± δx and y ± δy . since it is assumed that the two errors δx and δx and the two errors δy and δy are the same , the measured location of the unknown target can be correct , as will be familiar to one skilled in the art . it has been found that such a procedure significantly improves the accuracy of gaze direction tracking . the gaze direction tracking system described above may be modified by positioning all the controls other than on the computer screen and spaced from the edges of the screen .

US-90327607-A

the decorative fastener includes a base fitted with eyes or receptacles on the underside of the base and one or two straps that protrude from the lower portion of the base underside and which are fitted with hooks on their exposed ends . the straps wrap back over themselves , around any particular item of wear , and fasten using the hooks on the straps and the eyes on the underside of the base . the decorative fastener may also include a plurality of interchangeable decorative disc options , or removable strap options , thus allowing the wearer to change decorations easily and inexpensively .

fig1 is a view of an embodiment of a decorative fastener 10 . the decorative fastener 10 comprises a base 12 , two parallel placed straps 14 , a hook 16 at the exposed end of each strap 14 , two raised eyes 18 set side by side at the top portion of the underside of the base . an embodiment of the base 12 may be manufactured of a hard material , whether composite , metal , plastic or some other material , or a flexible , yet firm material that may comprise any decorative shape and may have a decorative design permanently applied , or embedded upon the top portion . two straps , placed in a parallel formation 14 protrude from slotted openings 20 which are then clamped to secure the straps 14 to the underside of the base 12 . each of the straps 14 has a hook 16 affixed to their exposed ends . the straps 14 fold back upon themselves in order that the hooks 16 may be connected to the raised eyes 18 which protrude from the underside of the base 12 thus creating the shape of a loop . it should be understood that the straps 14 may be made of any material ; and , by way of example and not limitation , may include ; whether singularly or in combination , rubber , silicone and polyester , or any other material known to those skilled in the art . further , it should be understood that the raised eyes 18 may or may not be a formation of the actual base 12 . by way of example ; the raised eyes 18 may be separate pieces that are affixed to the base 12 . finally , other means for fastening the exposed ends of the straps 14 to the base 12 that are well known to a person of ordinary skill in the art may be used in place of the hooks 16 and eyes 18 . for example , hook and loop tape , two sets of male and female snap fasteners , hooks and rubber loop combinations , or any other mechanism known to those skilled in the art . any means for fastening the unexposed ends of the straps 14 to the base 12 that are well known to a person of ordinary skill in the art may be used in place of slotted , then clamped openings 20 in the base 12 . for example , the straps 14 may be held fast using a strong adhesive or covering that would ensure a tight hold . in addition to producing the decorative fastener 10 with two parallel straps 14 , it may also be produced using only a single strap 14 . producing an optional decorative fastener 10 with a single strap 14 will make it easier for the user to attach the device to certain articles of wear . fig2 is a side perspective view of the attachment device showing the base 12 , the two parallel straps 14 , the hooks 16 attached at the exposed end of the straps 14 , the raised eyes or receptacles 18 and an example of a decorative feature 22 , which may or may not be applied to the top portion of the base 12 . fig3 is a top planar view of the underside of the decorative fastener 10 showing the two , parallel straps 14 as they wrap around sandal straps 24 . the hooks 16 will attach to the raised eyes 18 as shown in fig1 . fig4 is top perspective view showing the decorated side of the base 12 as it sits completely affixed to the sandal straps 24 . fig5 is a side perspective view of the decorative fastener 10 with an optional , interchangeable decorative disc feature 26 . the interchangeable disc 26 could be fitted with a strong magnet 28 on the underside . the base 12 could be made of metal or fitted with a strong , metal piece 30 which would attract to the magnet 28 on the interchangeable disc 26 . other means for fastening the interchangeable disc 26 to the base 12 that are well known to a person of ordinary skill in the art may be used in place of the magnet 28 and metal piece 30 . for example , the interchangeable disc 26 and the base 12 may comprise hook and loop tape , a male and female snap fastener , a male and female screw assembly , a hook and eye configuration , a post and clasp assembly , or any other mechanism known to those skilled in the art . fig6 shows the embodiment of a decorative fastener 10 wherein the straps 14 a of the device have the capability of being completely removed from a base 12 . the base 12 may comprise any decorative shape and may have a decorative design permanently applied , or embedded upon the top portion . said base 12 comprises one set of two eyes 18 , or some other fastener set side by side at the upper portion of the underside of the base 12 and one set of two eyes 18 , or some other fastener , set side by side at the lower portion of the underside of the base 12 . said base 12 may also comprise one eye 18 , or some other fastener on the left portion of the underside of the base 12 and one eye 18 or some other fastener on the right portion of the underside of the base 12 . two , separate straps of equal length 14 a are fitted with hooks 16 or some other fastener on each exposed end . one hook 16 at one end of each strap 14 a would connect with one of the eyes 18 at the upper portion of the underside of the base 12 and one hook 16 at the opposite end of each strap 14 a would connect with one of the eyes 18 at the lower portion of the underside of the base 12 creating loops that would wrap around the straps of sandals or some other item of wear . fig7 shows the embodiment of the attachment device 10 using only one , completely removable strap 32 . said strap 32 is fitted with hooks 16 , or some other fastener on each exposed end . one hook 16 at one end of the strap 32 would connect with the eye 18 on the left portion of the underside of the base 12 and the hook 16 on the other end of the strap 32 would connect with the eye 18 on the right portion of the underside of the base creating one loop that would wrap around an item that may require only one strap 32 such as a scarf or hair ponytail . further , it should be understood that the decorative fastener as shown in fig6 and fig7 may have the same interchangeable decorative disc options as shown in fig5 . although all versions of the decorative fastener have been described in detail , it should be understood that various changes , substitutions and alterations may be made hereto without departing from the spirit and scope of the invention as defined by the appended claims .

US-201213651159-A

construction - set elements for use in kits for children and in puzzles . the construction - set element contains a flat rectangular base and a connecting assembly . the connecting assembly is formed of four groups of protrusions , provided on the base . the protrusions of the first group have a cruciform cross - section . the protrusions of the second group are tubular with a square - shaped cross - section . the protrusions of the third group are in the form of rectangular plates having barrier - walls along the short sides thereof , the barrier - walls being angled toward one another with the formation of a gap . in the fourth group , the protrusions are positioned at the corners of the base and are made in the form of l - shaped elements , the sides of which are perpendicular to the plane of the base .

here we describe a construction element , according to the first embodiment , see fig1 - 6 , where the interlocking joint made of protrusions and construction element according to the first embodiment with abovementioned interlocking joint are represented respectively . construction element , according to the first embodiment , contains a base 1 , made flat and having a rectangular form , with sides made in multiples of & lt ;& lt ; a & gt ;& gt ;, and an interlocking joint , created by positioning protrusions on the base , which form four groups of protrusions . the first group of protrusions 2 ( see fig1 , 6 , 7 , 8 , 10 and 16 ) is positioned at least on one side of the base 1 . the height of the protrusions 2 ( see fig1 ) & lt ;& lt ; h 1 & gt ;& gt ; in the first group is greater than & lt ;& lt ; 0 . 5a & gt ;& gt ; but no greater than & lt ;& lt ; a & gt ;& gt ;. the protrusions 2 are made with a cross - shaped cross - section where a distance & lt ;& lt ; b 1 & gt ;& gt ; between opposite ends of the cross is equal to & lt ;& lt ; a & gt ;& gt ;. the protrusions 3 are of the second group according to the first embodiment ( see fig2 , 6 , 10 , 12 , 13 , 14 , 17 and 18 ) are also positioned at least on one side of the base 1 . the height of the protrusions 3 & lt ;& lt ; h 2 & gt ;& gt ; is equal to & lt ;& lt ; 0 . 5a & gt ;& gt ;. the protrusions 3 are made tubular , with cross - sections in the form of a square having side length in channel of the tubular protrusion 3 equal to & lt ;& lt ; a & gt ;& gt ;. in the third group , protrusions 4 according to the first embodiment ( see fig3 , 6 , 7 , 8 , 11 , 12 , 13 , 15 , 16 , 17 and 18 ) are made in the form of rectangular plates , positioned with its longest midline on the ends of the base 1 , and having ledges 5 along their short sides . the ledges 5 with width & lt ;& lt ; b 3 & gt ;& gt ; equal to & lt ;& lt ; a & gt ;& gt ; are maid protruding from the base ends by a length & lt ;& lt ; b 4 & gt ;& gt ; ( see fig3 ) which is not more than & lt ;& lt ; 0 . 5a & gt ;& gt ;, angled towards each other with a gap formed between their end parts no greater than & lt ;& lt ; a & gt ;& gt ; ( see fig3 , 6 , 7 , 8 , 11 , 12 , 13 , 15 , 16 and 17 ). ledges 5 are angled towards each other with a gap & lt ;& lt ; δ & gt ;& gt ; formed between their end parts no greater than & lt ;& lt ; a & gt ;& gt ; ( see fig3 ). protrusions 6 in the fourth group according to the first embodiment are made in the form of corners , having shelves positioned perpendicular to the base 1 planes on its adjacent ends and flush with these ends , the shelf length & lt ;& lt ; l & gt ;& gt ; is equal to & lt ;& lt ; a & gt ;& gt ; and width & lt ;& lt ; b 5 & gt ;& gt ; is no greater than & lt ;& lt ; 0 . 5a & gt ;& gt ;. protrusions 2 , 3 , 4 , 6 are positioned on the base 1 in accordance with the coordinate grid 7 ( see fig5 and 7 ) of mutually perpendicular lines parallel to base 1 edges . the distance & lt ;& lt ; b 6 & gt ;& gt ; between neighboring lines of the coordinate grid 7 is equal to & lt ;& lt ; 2a & gt ;& gt ;, wherein the distance & lt ;& lt ; b 7 & gt ;& gt ; between the base 1 edges and neighboring lines on the coordinate grid 7 is equal to & lt ;& lt ; 0 . 5a & gt ;& gt ;. in the first group according to the first embodiment protrusions 2 are positioned at points where the coordinate grid 7 lines intersect . in the second group according to the first embodiment protrusions 3 are positioned at points where the diagonals 8 ( see fig5 ) of the cells of the coordinate grid 7 intersect . protrusions 4 of the third group according to the first embodiment are positioned in the middle between the neighboring protrusions 2 of the first group that are positioned flush with the ends of the base 1 . in the fourth group according to the first embodiment protrusions 6 are positioned in the corners of the base 1 . here we describe a construction element , according to the second embodiment . fig1 , 4 , 7 , 8 show protrusions creating interlocking joint and a construction element , according to the second embodiment , containing the abovementioned interlocking joint . construction element , according to the second embodiment , contains a base 1 , made flat and having a rectangular form , with at least one side equal to & lt ;& lt ; a & gt ;& gt ;, the other a multiple of & lt ;& lt ; a & gt ;& gt ;, and an interlocking joint , created by positioning protrusions on the base 1 , which form three groups of protrusions . the first group of protrusions 2 according to the second embodiment are similar to of protrusions 2 according to the first embodiment . they are positioned at least on one side of the base 1 . the height & lt ;& lt ; h 1 & gt ;& gt ; of the protrusions 2 is greater than & lt ;& lt ; 0 . 5a & gt ;& gt ; but no greater than & lt ;& lt ; a & gt ;& gt ;. the protrusions 2 are made with cross - shaped cross - sections with a distance & lt ;& lt ; b 1 & gt ;& gt ; between opposite cross ends equal to & lt ;& lt ; a & gt ;& gt ;. in the second group according to the second embodiment , protrusions 4 are similar to protrusions 4 of the third group according to the first embodiment and made in the form of rectangular plates , positioned with its long midline on the ends of the base 1 , and having ledges 5 along short sides , flush with these ends . ledges 5 with a width length “ b 3 ” equal to & lt ;& lt ; a & gt ;& gt ; ( see fig8 ) are protruding from the base ends by a length “ b 4 ” ( see fig3 ), which is not more than & lt ;& lt ; 0 . 5a & gt ;& gt ;. ledges 5 angled towards each other with a gap & lt ;& lt ; δ & gt ;& gt ; formed between their end parts no greater than & lt ;& lt ; a & gt ;& gt ; ( see fig3 ). protrusions 6 in the third group according to the second embodiment are similar to protrusions 6 of the third group according to the first embodiment . they are made in the form of corners , having shelves positioned perpendicular to the base 1 planes on its adjacent ends and flush with these ends , with a length & lt ;& lt ; l & gt ;& gt ; equal to a and width & lt ;& lt ; b 5 & gt ;& gt ; no greater than & lt ;& lt ; 0 . 5a & gt ;& gt ;. protrusions 2 , 4 and 6 are positioned on the base 1 according to the coordinate grid 7 of mutually perpendicular lines parallel to base 1 edges , wherein the distance & lt ;& lt ; b 6 & gt ;& gt ; between neighboring lines of the coordinate grid 7 is equal to & lt ;& lt ; 2a & gt ;& gt ;, wherein the distance & lt ;& lt ; b 7 & gt ;& gt ; between the base 1 edges and neighboring lines on the coordinate grid 7 is & lt ;& lt ; 0 . 5a & gt ;& gt ;. protrusions 2 of the first group according to the second embodiment are positioned at points where the coordinate grid 7 lines intersect . protrusions 4 of the second group according to the second embodiment are positioned in the middle between the neighboring protrusions 2 of the first group that are positioned flush with the ends of the base 1 . protrusions 6 of the third group according to the second embodiment are positioned in the corners of the base 1 . protrusions of interlocking joints , for a more precise positioning of construction elements during connection with each other , can be implemented with bevels , rounded off , sloped , and so forth . the base 1 can also be made with various openings to conserve materials . for instance , the openings may be made inside the protrusions 3 of the second group according to the first embodiment ( see fig9 ). positioning of interlocking joints on base 1 is presented in fig5 and 7 , in particular . when connecting construction elements to one another , the protrusions of different elements interlock with each . interlocking is based on the force of friction , occurring between protrusions during close contact and / or when they are placed between other protrusions . when connecting elements to one another , the protrusions of different groups simultaneously engage in interlocking from any side , which provides opportunity to make complicated volumetric ( 3 - dimensional ) models ( see fig1 - 23 ).

US-201514952937-A

a cardiac rhythm management system provides for ambulatory monitoring of hemodynamic performance based on quantitative measurements of heart sound related parameters for diagnostic and therapeutic purposes . monitoring of such heart sound related parameters allows the cardiac rhythm management system to determine a need for delivering a therapy and / or therapy parameter adjustments based on conditions of a heart . this monitoring also allows a physician to observe or assess the hemodynamic performance for diagnosing and making therapeutic decisions . because the conditions of the heart may fluctuate and may deteriorate significantly between physician visits , the ambulatory monitoring , performed on a continuous or periodic basis , ensures a prompt response by the cardiac rhythm management system that may save a life , prevent hospitalization , or prevent further deterioration of the heart .

the following detailed description includes references to the accompanying drawings , which form a part of the detailed description . the drawings show , by way of illustration , specific embodiments in which the invention may be practiced . these embodiments , which are also referred to herein as “ examples ,” are described in enough detail to enable those skilled in the art to practice the invention . the embodiments may be combined , other embodiments may be utilized , or structural , logical and electrical changes may be made without departing from the scope of the present invention . the following detailed description is , therefore , not to be taken in a limiting sense , and the scope of the present invention is defined by the appended claims and their equivalents . in this document , the terms “ a ” or “ an ” are used , as is common in patent documents , to include one or more than one . in this document , the term “ or ” is used to refer to a nonexclusive or , unless otherwise indicated . furthermore , all publications , patents , and patent documents referred to in this document are incorporated by reference herein in their entirety , as though individually incorporated by reference . in the event of inconsistent usages between this document and those documents so incorporated by reference , the usage in the incorporated reference ( s ) should be considered supplementary to that of this document ; for irreconcilable inconsistencies , the usage in this document controls . this document discusses , among other things , a system monitoring heart sounds indicative of a heart &# 39 ; s mechanical events related to the heart &# 39 ; s pumping functions and hemodynamic performance to allow , among other things , diagnosis of cardiac conditions and selection of therapies treating the cardiac conditions . the cardiac rhythm management systems include systems having , for example , pacemakers , cardioverter / defibrillators , pacemaker / defibrillators , and cardiac resynchronization therapy ( crt ) devices . one specific example of a cardiac rhythm management system that monitors and analyses heart sounds is described in co - pending , commonly assigned siejko et al . u . s . patent application ser . no . 10 / 307 , 896 , entitled “ phonocardiographic image - based atrioventricular delay optimization ,” filed dec . 2 , 2002 , now issued as u . s . pat . no . 7 , 123 , 962 , which is hereby incorporated by reference in its entirety . however , it is to be understood that the present methods and apparatuses may be employed in other types of medical devices , including , but not being limited to , drug delivery systems and various types of cardiac monitoring devices . known and studied heart sounds include the “ first heart sound ” or s1 , the “ second heart sound ” or s2 , the “ third heart sound ” or s3 , the “ fourth heart sound ” or s4 , and their various sub - components . s1 is known to be indicative of , among other things , mitral valve closure , tricuspid valve closure , and aortic valve opening . s2 is known to be indicative of , among other things , aortic valve closure and pulmonary valve closure . s3 is known to be a ventricular diastolic filling sound often indicative of certain pathological conditions including heart failure . s4 is known to be a ventricular diastolic filling sound resulted from atrial contraction and is usually indicative of pathological conditions . the term “ heart sound ” hereinafter refers to any heart sound ( e . g ., s1 ) and any components thereof ( e . g ., m1 component of s1 , indicative of mitral valve closure ). throughout this document , “ heart sound ” includes audible and inaudible mechanical vibrations caused by cardiac activity that can be sensed with an accelerometer . accordingly , the scope of “ acoustic energy ” in this document extends to energies associated with such mechanical vibrations . throughout this document , “ user ” refers to a physician or other caregiver who examines and / or treats a patient using one or more of the methods and apparatuses reported in the present document . unless noted otherwise , s1 , s2 , s3 , and s4 refer to the first , second , third , and fourth heart sounds , respectively , as a heart sound type , or as one or more occurrences of the corresponding type heart sounds , depending on the context . fig1 is a block diagram illustrating an embodiment of a heart - sound based hemodynamics monitoring and therapy control system 100 . system 100 includes , among other things , an acoustic sensor 110 , a sensor interface module 120 , a cardiac sensing circuit 112 , a heart sound detector 130 , a parameter generator 140 , a data acquisition timer 118 , a parameter processor 160 , and a therapy circuit 170 . in one embodiment , system 100 is a totally implantable system adapted to be implanted into a patient . in an alternative embodiment , system 100 is an external system that does not include any implantable component . in another alternative embodiment , system 100 includes both implantable and external components . acoustic sensor 110 senses an acoustic energy or mechanical vibration energy related to cardiac mechanical activities and converts the acoustic energy to an acoustic sensor signal indicative of heart sounds . the acoustic sensor signal is an electrical signal indicative of timing , strength , and frequency characteristics related to the heart sounds . acoustic sensor 110 is disposed in a heart , or near the heart in a location where the acoustic energy related to the cardiac mechanical activities can be sensed . in one embodiment , acoustic sensor 110 includes an accelerometer disposed in or near a heart . in another embodiment , acoustic sensor 110 includes a microphone disposed in or near a heart . sensor interface module 120 has a signal input connected to the output of acoustic sensor 110 to receive the acoustic sensor signal . it processes the acoustic sensor signal to prepare for detection of selected type heart sounds . the selected type heart sounds are heart sounds selected for a purpose of monitoring a patient &# 39 ; s hemodynamic performance indicated by the measurable characteristics of these heart sounds . in one specific embodiment , the selected type heart sounds includes s3 and s4 , which are indicative of ventricular diastolic hemodynamic performance . sensor interface module includes a signal conditioning circuit 122 , a digitizer 124 , and a digital filter 126 . signal conditioning circuit 122 receives the acoustic sensor signal as an analog signal from acoustic sensor 110 , and performs initial conditioning of the acoustic sensor signal . in one embodiment , signal conditioning circuit 122 improves the signal - to - noise ratio of the acoustic sensor signal . it includes an amplifier and a filter to amplify the acoustic sensor signal while reducing the noise therein . in one embodiment , the filter is an analog filter that substantially reduces amplitudes of noises that are not within the frequency spectrum of the selected type heart sounds . in another embodiment , the filter substantially reduces amplitudes of noises as well as components of the acoustic sensor signal that are outside of the frequency range of the selected type heart sounds . digitizer 124 digitizes the filtered acoustic sensor signal by sampling it at a predetermined rate . in one embodiment , the sampling rate is programmable and determined based on known frequency characteristics of the heart sounds to be detected . in one embodiment , digitizer 124 samples the acoustic sensor signal only during predetermined periods of time where the selected type heart sounds are most likely to be present . this saves electrical energy required for processing the acoustic sensor signal and / or allows a higher resolution of the digitized acoustic sensor signal without substantially increasing the electrical energy required for processing . energy conservation is of particular importance when system 100 is a totally implantable system or includes implantable components . digital filter 126 substantially reduces amplitudes for all components of the acoustic sensor signal except the selected type heart sounds , which are to be detected by heart sound detector 130 , thereby enhancing the indications of the selected type heart sounds . in one embodiment , digital filter 126 includes a band - pass filter having cutoff frequencies determined based on the frequency spectrum of the selected type heart sounds . it is to be understood , however , that the cutoff frequencies are dependent on the purpose of detection and need not cover exactly the known spectrum of particular heart sounds . in one specific embodiment , digital filter 126 is band - pass filter having a low cutoff frequency in the range of 5 to 20 hz and a high cutoff frequency in the range of 30 to 120 hz selected for the purpose of detecting s3 and s4 . one example of a suitable pass band for digital filter 126 for detection of s3 and s4 for monitoring ventricular diastolic hemodynamics includes a low cutoff frequency of 10 hz and a high cutoff frequency of 60 hz . in one specific embodiment , digital filter 126 is an envelope detector type filter . in one embodiment , digital filter 126 is a programmable digital filter in which at least one of the cutoff frequencies is programmable . this allows a dynamic selection of heart sounds for detection without a need for additional circuitry . cardiac sensing circuit 112 senses at least one cardiac signal indicative of cardiac electrical events that are needed for detection and measurements related to the heart sounds and / or their components . in one embodiment , the cardiac signal includes a surface ecg signal . in another embodiment , the cardiac signal includes an intracardiac ecg signal that is also referred to as an electrogram . cardiac sensing circuit 112 includes a sensing amplifier to sense the cardiac signal , a cardiac events detector to detect the cardiac electrical events , and an event marker generator to label each detected cardiac electrical event with an event marker indicative of the timing and type of the detected cardiac electrical event . the detected electrical events include , by not limited to , selected atrial and ventricular contractions . the atrial and ventricular contractions include spontaneous contractions and artificially stimulated contractions . heart sound detector 130 detects the selected type heart sounds . in one embodiment , heart sound detector 130 detects the selected type heart sounds based on the acoustic sensor signal . in another embodiment , heart sound detector 130 detects the selected type heart sounds based on the acoustic sensor signal and the cardiac signal sensed by cardiac sensing circuit 112 . in one embodiment , heart sound detector includes a gating module 132 and a detection module 134 . gating module 132 receives the acoustic sensor signal from sensor interface module 120 and the cardiac signal from cardiac sensing circuit 112 . in one embodiment , the cardiac signal received by gating module 132 includes event makers representing the detected cardiac electrical events that allow or facilitate detection of the selected type heart sounds . gating module 132 generates heart sound detection windows each timed for detection of one of the selected type heart sounds based on a time of occurrence of one of cardiac electrical events . fig2 illustrates , by way of example , but not by way of limitation , a heart sound detection window . as illustrated in fig2 , a cardiac signal 200 indicates a heart contraction 202 . an event marker signal 210 , which is a representation of cardiac signal 200 , includes an event marker 212 representing heart contraction 202 . an acoustic sensor signal 230 , simultaneously recorded with cardiac signal 200 , includes an indication of a heart sound 235 . based on available medical knowledge including statistical information available for an individual patient , heart sound 235 is substantially probable to occur within a time period t2 which starts after a time period t1 triggered by event marker 212 representing heart contraction 202 . thus , gating module 132 generates a heart sound detection window having a duration of t2 at the end of t1 following each heart contraction used for detection of the selected type heart sounds . in another embodiment , another heart sound ( of a different type than the selected type ) substitutes heart contraction 202 to trigger t1 , and gating module 132 generates the heart sound detection window t2 at the end of t1 following each heart sound used for detection of the selected type heart sounds . in one embodiment , the heart sound detection windows are used to conserve energy and / or computational resources of system 100 by limiting the need for detection and subsequent computations to periods within the heart sound detection windows . in another embodiment , it is difficult or practically impossible to differentiate one type of the heart sounds from another by amplitude or frequency spectrum . this necessitates a method of detection that is not based on the amplitude or frequency spectrum of the selected type heart sounds . one feasible method includes the use one or more heart sound detection windows each corresponding to one or more types of heart sounds , thus allowing detections of heart sounds based on their predicted ranges of time of occurrence . durations of the windows are determined based on an empirical study on the timing of each type of heart sounds relative to a type of cardiac . heart sound detector 134 detects the selected type heart sounds . in one embodiment , heart sound detector 134 detects the selected type heart sounds within the one or more heart sound detection windows . in one embodiment , heart sound detector 134 includes one or more comparators to detect the selected type heart sounds by comparing the amplitude of the acoustic sensor signal during the one or more heart sound detection windows with one or more predetermined detection thresholds . following the detections of the selected type heart sounds by heart sound detector 130 , parameter generator 140 makes measurements to generate parameter values of at least one predetermined parameter related to the detected heart sounds . in one embodiment , such a parameter value is measured from one detected heart sound . in another embodiment , the parameter value is calculated based on measurement of several detected heart sounds of the same type . the parameter values indicate the patient &# 39 ; s hemodynamic performance , either directly or after further processing as discussed below . parameter generator 140 includes a measurement module 150 to make measurements on the acoustic sensor signal . the measurements are timed with the detections of the selected type heart sounds . in one embodiment , measurement module 150 receives the acoustic sensor signal from heart sound detector 130 and the cardiac signal from cardiac sensing circuit 112 . fig3 is a block diagram that illustrates , by way of example , but not by way of limitation , components of measurement module 150 . as illustrated in fig3 , measurement module 150 includes a strength detector 351 , a relative strength detector 352 , a duration timer 353 , an electromechanical interval timer 354 , a mechanical interval timer 355 , and a frequency analyzer 356 . strength detector 351 measures amplitudes each associated with a detected heart sound . relative strength detector 352 determines differences each between amplitudes associated with two detected heart sounds . duration timer 353 measures durations each associated with a detected heart sound . electromechanical interval timer 354 measures electromechanical time intervals each between a detected heart sound and a cardiac electrical event detected from the cardiac signal . mechanical interval time 355 measures mechanical time intervals each between two detected heart sounds . frequency analyzer 356 computes fundamental and / or harmonic frequencies each associated with a detected heart sound . in one embodiment , measurement module 150 calculate one or more parameter values each based on several values of a predetermined parameter measured by one of the components of measurement module 150 . in one specific embodiment , measurement module 150 calculates the one or more parameter values each being an average of the several values of the predetermined parameter . because of the nature and property of the acoustic sensor , the parameter values output from measurement module 150 may includes those affected by background interference . for example , when the acoustic sensor is an accelerometer , the acoustic sensor signal may indicate a patient &# 39 ; s physical activities in addition to the heart sounds . when the acoustic sensor is a microphone , the acoustic sensor signal may indicate talking and other environment sounds in addition to the heart sounds . thus , in one embodiment , parameter generator 140 includes a screening module 144 to exclude parameter values resulted from measurements performed when a background noise level exceeds a predetermined threshold . in one embodiment , a noise monitoring module 142 measures the background noise level . in one specific embodiment , noise monitoring module 142 includes an activity sensor that senses a patient &# 39 ; s physical activities and an activity sensor interface module to convert the physical activities to the background noise level . in another specific embodiment , noise monitoring module includes a further sensor interface module coupled to acoustic sensor 110 , which senses the patient &# 39 ; s physical activities in addition to the acoustic energy related to the patient &# 39 ; s cardiac mechanical activities . when acoustic sensor 110 includes an accelerometer , the further sensor interface module includes an activity level detector to produce the background noise level signal indicative of the patient &# 39 ; s physical activities . the activity level as indicated by the acoustic sensor signal has a distinctively higher amplitude than the heart sounds . thus , the activity level detector distinguishes the patient &# 39 ; s physical activities from the heart sounds by using a predetermined activity level threshold . in one embodiment , parameter generator 140 includes a memory circuit 146 to store the parameter values generated by measurement module 150 . in another embodiment , memory 146 stores only parameters screened by screening module 144 . data acquisition enabler 118 controls the timing of overall data acquisition by timing the enablement of selected system components including at least one or more of acoustic sensor 110 , sensor interface module 120 , cardiac sensing circuit 112 , heart sound detector 130 , and parameter generator 140 . in one embodiment , data acquisition enabler 118 enables the selected system components in response to an external command , such as given by the user . in another embodiment , data acquisition enabler 118 includes a data acquisition timer to enable the selected system components on a predetermined schedule . in one specific embodiment , the data acquisition timer enables the selected system components on a predetermined periodic basis . in another specific embodiment , if parameter generator 140 is unable to generate required parameter values on the predetermined schedule , for example , because the background noises exceeds the predetermined level when the selected system components are enabled , data acquisition enabler 118 modifies the predetermined schedule by introducing at least one delay to ensure that all the desired parameter values are obtained . parameter processor 160 processes the parameter values received from parameter generator 140 . in one embodiment , parameter processor 160 includes a statistical processor 162 , a trending analyzer 164 , and an alert signal generator 166 . statistical processor 162 analyzes the parameter values generated by parameter generator 140 for a predetermined period of time . trending analyzer 164 produces at least one trend related to the selected type heart sounds . the trend is a hemodynamic performance trend indicative of one or more cardiac conditions . in one embodiment , the trend is a plot of parameter values of one selected parameter related to the detected heart sounds over a predetermined period of time . in another embodiment , the trend is a plot of values derived for the parameter values as a result of the statistical process over the predetermined period of time . alert signal generator 166 generates an alert signal indicative of a presence of the one or more cardiac conditions indicated by the at least one trend . in one embodiment , alert signal generator 166 includes a comparator . the comparator has a first input to receive the at least one trend , a second input representative of a predetermined threshold level , and an output indicative of the presence of the one or more clinical conditions when the at least one trend exceeds the predetermined threshold level . in one further embodiment , alert signal generator 166 includes a threshold generator that generates an adaptive threshold level based on at least one previously produced trend , such that the predetermined threshold is dynamically adjustable based on the patient &# 39 ; s changing cardiac conditions . therapy circuit 170 includes , by way of example , but not by way of limitation , one or more of a pacing circuit , a defibrillation circuit , a cardiac resynchronization circuit , and a drug delivery circuit . it includes a therapy controller to execute a predetermined therapy algorithm that times therapy deliveries based on the processed cardiac signal and acoustic sensor signal . in one embodiment , the therapy controller receives at least one of selected parameter values generated by parameter generator 140 , the at least one trend generated by trending analyzer 164 , and the alert signal generated by alert signal generator 166 , based on which it produces or adjusts one or more therapy parameters . fig4 is a flow chart illustrating an embodiment of a method for hemodynamics monitoring and therapy control using system 100 . at 400 , data acquisition for the hemodynamics monitoring and therapy control begins . in one embodiment , the data acquisition begins as system 100 is activated . in one embodiment , the data acquisition begins in response to a user command . in another embodiment , the data acquisition begins at a predetermined time or upon a predetermined triggering event . in one embodiment , the date acquisition lasts for a predetermined duration after it begins . in one specific embodiment , the data acquisition begins on a predetermined periodic basis and lasts for a predetermined duration . at 402 , acoustic sensor 110 senses the acoustic energy related to cardiac mechanical activities and converts the acoustic energy to an acoustic sensor signal indicative heart sounds . in one embodiment , acoustic sensor 110 senses an acceleration indicative of the acoustic energy . at 410 , sensor interface module 410 processes the acoustic sensor signal to prepare for heart sound detection . in one embodiment , the acoustic sensor signal is amplified and filtered to increase its signal - to - noise ratio . then , the acoustic sensor signal is digitized to the form of binary data . the digitized acoustic sensor signal is filtered to enhance indications of the selected type heart sounds . in one embodiment , the digitized acoustic sensor signal is filtered with at least one cutoff frequency determined based on the frequency spectrum of the selected type heart sounds . at 420 , heart sound detector 130 generates heart sound detection windows each timed for detecting one of the selected type heart sounds . the heart sound detection windows are each triggered by one of selected cardiac electrical events detected from the cardiac signal sensed at 404 . in one embodiment , the selected cardiac electrical events include at least one of spontaneous or artificially stimulated atrial and ventricular contractions . in one embodiment , the selected cardiac electrical events are each represented by a predetermined event marker . in one specific embodiment , at 425 , the selected type heart sounds are detected . in one embodiment , each of the selected type heart sounds is detected when the amplitude of the acoustic sensor signal exceeds a predetermined threshold level . at 430 , parameter generator 140 generates the parameter values of at least one parameter related to the detected heart sounds based on the acoustic sensor signal produced at 400 and / or the cardiac signal sensed at 404 . such parameter values include , by way of example , but not by way of limitation , one or more of ( i ) an amplitude associated with one or one selected type of the selected type heart sounds ; ( ii ) a relative strength being differences between amplitudes associated with two or two selected types of the selected type heart sounds ; ( iii ) a duration associated with one or one selected type of the selected type heart sounds ; ( iv ) an electromechanical time intervals between one or one selected type of the selected type heart sounds and one or one type of selected type cardiac electrical events ; ( v ) a mechanical time interval between two or two selected types of the selected type heart sounds ; and ( vi ) a fundamental or harmonic frequency associated with one or one selected type of the selected type heart sounds . in one embodiment , parameter values related to s3 and / or s4 are measured and / or calculated for the purpose of monitoring ventricular diastolic hemodynamic performance . the parameter values of one or more of the following parameters are generated : ( i ) peak amplitude of s3 ; ( ii ) time of onset of s3 relative to onset of s2 ; ( iii ) duration of s3 ; ( iv ) fundamental frequency if s3 ; ( v ) time of occurrence of s3 relative to the subsequently adjacent atrial contraction ; ( vi ) peak amplitude of s4 ; ( vii ) time interval between atrial contraction and the subsequently adjacent s4 ; ( viii ) fundamental frequency of s4 ; ( ix ) duration of s4 ; ( x ) time of occurrence of s4 relative to the subsequently adjacent ventricular contraction ; and ( xi ) amplitude of s4 relative to amplitude of s3 . in one embodiment , parameter generator 140 screens out noisy values of the parameter values measured at 435 . such noisy values include parameter values measured when the background noise level exceeds a predetermined threshold . in one embodiment , the patient &# 39 ; s physical activities are sensed at 406 to produce an activity level signal indicative of the background noise level . in one specific embodiment , the activity level signal is derived from the same acoustic sensor signal from which the selected type heart sounds are detected . this is possible because the patient &# 39 ; s physical activities are typically indicated with amplitudes that are distinctively higher than the amplitudes of the selected type heart sounds . at 440 , the parameter values are stored in memory circuit 146 or other storage medium . in one embodiment , system 100 uses the parameter values directly to control delivery of at least one therapy with at least one therapy parameter being a function of the parameter values . in another embodiment , the parameter values are further processed and analyzed by system 100 for monitoring , diagnosis , and / or therapy control purposes . in yet another embodiment , the stored parameter values are transferred to another system , such as a computer separated from system 100 , for further processing and / or analysis . at 450 , parameter processor 160 statistically processes the parameter values . the statistical process includes analyzing the parameter values of the at least one parameter related to the detected heart sounds in relation to historical values of that parameter measured during a predetermined period of time . the outcome of the statistical process reveals changes in cardiac conditions reflected in the characteristics of the selected type heart sounds . in one embodiment , the outcome of the statistical process reveals changes in ventricular diastolic filing patterns during the predetermined period of time . in one specific embodiment , the predetermined period of time ranges from 1 day to 3 months . at 460 , parameter processor 160 produces at least one hemodynamic performance trend related to the selected type heart sounds . in one embodiment , parameter processor 160 produces the at least one trend based on the outcome of the statistical analysis . in one embodiment , one or more trends quantitatively present one or more ventricular diastolic filing pattern changes during a predetermined duration . in one embodiment , parameter processor 160 plots the parameter values of the at least one parameter related to the detected heart sounds versus time . in another embodiment , parameter processor 160 statistically processes the parameter values of the at least one parameter related to the detected heart sounds and plots the result . at 465 , the one or more trends are analyzed for indication of cardiac conditions . in one embodiment , the values of each trend are compared to a predetermined threshold level , and a predefined cardiac condition is indicated when any value exceeds the predetermined threshold level . in one embodiment , the predetermined threshold level is determined based on at least one previously produced trend . at 475 , an alert signal is generated when a cardiac condition is indicated by the at least one hemodynamic performance trend at 470 . the alert signal notifies the user of the cardiac condition that may need medical attention . in one embodiment , the cardiac condition requires delivery of a therapy . in another embodiment , the alert signal indicates a need for changing one or more therapy parameters . in one embodiment , a therapy is delivered in response to the alert signal at 480 . the therapy includes one or more of , for example , a pacing therapy , a defibrillation therapy , a cardiac resynchronization therapy , any other electrical stimulation therapy , and a drug therapy . the type of the therapy as therapy parameters are determined based on the at least one trend and / or selected values of the at least one parameter related to the detected heart sounds . in one specific embodiment , therapy circuit 170 delivers the therapy . in another embodiment , one or more therapy parameters are adjusted in response to the alert signal , and the new therapy parameters are determined based on the at least one trend and / or the selected values of the at least one parameter related to the detected heart sounds . in an alternative embodiment , the therapy delivery or the therapy parameter adjustments are not dependent on the alert signal . the at least one trend and / or the selected values of the at least one parameter related to the detected heart sounds directly determine the need for the therapy delivery or the therapy parameter adjustments . many embodiments combining the present method with available medical knowledge will be apparent to those of skill in the art . in one example , the fundamental frequency ( also referred to as the pitch ) of s3 is correlated to the stiffness of the left ventricular wall during the rapid filling phase of diastole . the wall stiffness is proportional to diastolic pressure in the left ventricle and to the thickness of the left ventricular wall . therefore , an increase in the pitch of s3 is used to indicate one or more of an elevated left ventricular filling pressure and a thickened left ventricular wall . the elevation of the left ventricular filling pressure and / or the increase of the left ventricular wall thickness may reach a degree , represented by predetermined thresholds of s3 fundamental frequency , that requires an application of adjustment of a therapy . in another example , the amplitude of s3 is directly related to the rate of deceleration of blood flow into the left ventricle during the rapid filling phase of diastole . an increase in amplitude of s3 can be used to indicate an elevation of left atrial filling pressure , an increase in stiffness of the left ventricle , or both , which represent a restrictive filling pattern associated with heart failure . therefore , the trend of s3 amplitude is useful in monitoring cardiac mechanical properties related to heart failure . in yet another example , the elevated filling pressures cause pulmonary edema . thus , a physician determines the need of a drug therapy to relieve the elevated pressures based on one or more trends of parameters related to s3 . these are a few examples , among many possible embodiments , illustrating how system 100 is used . in general , trends of any of the measured parameter values can be used individually , jointly , and / or in combination with other trends related to cardiac functions . fig5 is an illustration of an embodiment of portions of a cardiac rhythm management system 599 and portions of an environment in which it is used . system 599 incorporates a heart - sound based hemodynamics monitoring and therapy control system such as system 100 . in one embodiment , cardiac rhythm management system 599 includes an implanted system 505 , an external system 580 , and a telemetry link 570 providing for communication between implanted system 505 and external system 580 . implanted system 505 includes an implanted device 506 and a lead system 508 . implanted device 506 is implanted within a patient &# 39 ; s body 502 and coupled to the patient &# 39 ; s heart 501 via lead system 508 . examples of implanted device 506 include pacemakers , cardioverter / defibrillators , pacemaker / defibrillators , cardiac resynchronization devices , and drug delivery devices . external system 580 is a patient management system including an external device 585 in proximity of implanted device 502 , a remote device 595 in a relatively distant location , and a telecommunication system 590 linking external device 585 and remote device 595 . an example of such a patient management system is discussed in hatlestad et al ., “ advanced patient management for defining , identifying and using predetermined health - related events ,” application ser . no . 10 / 323 , 604 , filed on dec . 18 , 2002 , assigned to cardiac pacemakers , inc ., the specification of which is incorporated herein by reference in its entirety . in one embodiment , telemetry link 570 is an inductive telemetry link . in an alternative embodiment , telemetry link 570 is a far - field radio - frequency telemetry link . in one embodiment , telemetry link 570 provides for data transmission from implanted device 506 to external device 585 . this may include , for example , transmitting real - time physiological data acquired by implanted device 506 , extracting physiological data acquired by and stored in implanted device 506 , extracting therapy history data stored in implanted device 506 , and extracting data indicating an operational status of implanted device 506 ( e . g ., battery status and lead impedance ). in a further embodiment , telemetry link 570 provides for data transmission from external device 585 to implanted device 506 . this may include , for example , programming implanted device 506 to acquire physiological data , programming implanted device 506 to perform at least one self - diagnostic test ( such as for a device operational status ), and programming implanted device 506 to deliver at least one therapy . in one embodiment , programming implanted device 506 includes sending therapy parameters to implantable device 506 . the therapy parameters provide an improved hemodynamic performance for a patient by delivering cardiac pacing pulses to the patient &# 39 ; s heart . in one embodiment , the therapy parameters providing for the improved hemodynamic performance are determined by monitoring one or more ventricular diastolic hemodynamics as indicated by parameters related to heart sounds such as s3 and s4 . such parameters indicate the heart &# 39 ; s mechanical activities and electromechanical association . in one specific embodiment , the acquisition of values of such parameters , the processing of the parameter values , and the subsequent determination of the therapy parameters are performed by system 100 , as discussed above with reference to fig1 - 3 . fig6 is a block diagram illustrating a specific embodiment of portions of cardiac rhythm management system 599 . in this embodiment , system 100 is substantially included within implanted device 506 . system 100 includes , as discussed above with reference to fig1 , acoustic sensor 110 , sensor interface module 120 , cardiac sensing circuit 112 , heart sound detector 130 , parameter generator 140 , data acquisition timer 118 , parameter processor 160 , and therapy circuit 170 . implanted device 506 also includes , among other things , an implant telemetry module 672 and an implant antenna 674 to provide implanted device 506 with telemetry capability allowing it to communicate with external system 580 via telemetry link 570 . in one embodiment , therapy circuit 170 includes a therapy controller that executes a predetermined therapy control algorithm to determine whether to deliver a therapy or adjust one or more therapy parameters based on the one or more of the heart sound - related parameter values generated by parameter generator 140 and trends and alert signal generated by parameter processor 160 . external system 580 includes , among other things , an external antenna 676 , an external telemetry module 678 , a controller 682 , and a user interface 684 . in one embodiment , external telemetry module 678 and external antenna 676 are included in external device 585 to provide external system 580 with capability of communicating with implanted device 506 through telemetry link 570 and external device 585 . controller 682 controls telemetry operation of external system 580 , processes signals received from implanted device 506 for presentation on user interface 684 , and processes user commands entered through user interface 684 for transmission to implanted device 506 . in one embodiment , one or more of the heart - sound related parameter values , trends , and alert signal , as discussed above , are acquired by system 100 and telemetered to external system 580 via telemetry link 570 . controller 682 executes a predetermined therapy control algorithm to determine whether to deliver a therapy or adjust one or more therapy parameters based on the one or more of the heart sound - related parameter values , trends , and alert signal . in one embodiment , system 100 is completely within a hermetically sealed can that houses at least portions of implanted device 506 . housing acoustic sensor 110 in the can has the advantage of minimizing the background noise associated with physical movements of the sensor , especially when acoustic sensor 110 includes an accelerometer . in another embodiment , acoustic sensor 110 is attached to a lead of lead system 508 . this allows disposition of acoustic sensor 110 in or near heart 501 such that it is near the mechanical activities being the sources of the heart sounds of interest . to include substantially the whole system 100 within implanted device 506 provides for the advantage of a self - contained implantable cardiac rhythm management system incorporating heart - sound based therapy control . in one embodiment , the heart - sound based therapy control using system 100 is able to function without telemetry link 570 , for example , when the patient is outside the range of the telemetry communication . implanted device 506 determines , without the intervention of the user or controller 682 , whether to deliver a therapy or adjust one or more therapy parameters based on the one or more of the parameter values , trends , and alert signal generated within itself by system 100 . fig7 is a block diagram illustrating another specific embodiment of portions of cardiac rhythm management system 599 . in this embodiment , system 100 is partially included within implantable device 506 and partially included in external system 580 . in one specific embodiment , parameter processor 160 is within external system 580 , and the remaining components of system 100 are within implanted device 506 . parameter values generated by parameter generator 140 are telemetered to external system 580 via telemetry link 570 for further processing by parameter processor 160 . in one embodiment , parameter processor 160 is included in external device 585 . in an alternative embodiment , parameter processor 160 is included in remote device 595 . in one embodiment , the parameter values are telemetered as they are generated . in another embodiment , parameter values are first stored in memory circuit 146 . data acquisition enabler 118 times transmission of the parameter values in response to a command from external device 580 or on a predetermined schedule . to include parameter processor 160 in external system 580 avoids placing the demand of energy and circuit resources required by parameter processor 160 in implanted device 506 , which is subject to design restraints including power and size limitations . the advantages also include the feasibility of updating parameter processing algorithms used by parameter processor 160 without the need of replacing implanted device 506 . it is to be understood that the above detailed description is intended to be illustrative , and not restrictive . for example , system 100 may be incorporated into any implanted or external medical device providing for ecg and heart sound monitoring . other embodiments will be apparent to those of skill in the art upon reading and understanding the above description . the scope of the invention should , therefore , be determined with reference to the appended claims , along with the full scope of equivalents to which such claims are entitled . generally , heart sounds , e . g ., s3 , are correlated to heart function . typically , heart failure arises when the pumping of the heart is compromised . as heart failure worsens , for various reasons , the pumping function of the heart typically deteriorates . as the pumping function of the heart deteriorates , the demand for blood to the body generally increases , typically resulting in an increased left atrial pressure . as the demand for blood to the body increases and the pumping function of the heart deteriorates , fluid typically builds in the lungs . generally , as fluid builds in the lungs , the demand for increased blood through the heart increases , also typically resulting in an increased left atrial pressure . thus , increased atrial pressure , including left atrial pressure , is an indicator of heart failure . a system and method have been developed to correlate one or more than one heart sound , e . g ., s3 , to atrial filling pressure , including left atrial filling pressure , and provide an alert , such as when high atrial filling pressure is detected . an increase of s3 amplitude , or another measurement , feature , characteristic , computation , or interval of a heart sound signal , can be used to indicate an elevation of left atrial filling pressure . therefore , the trend of s3 amplitude , or value of another measurement , feature , characteristic , computation , or interval of the heart sound signal , is useful in monitoring cardiac mechanical properties related to heart failure . using one or a combination of a measurement , feature , characteristic , computation , or interval of the heart sound signal , a high filling pressure can be detected , including a high atrial filling pressure , or a high left atrial filling pressure . using the detected pressure , an alert can be provided , such as for example when the pressure is detected above an absolute pressure threshold , e . g ., 25 mmhg . other alerts can also be provided , such as discussed elsewhere in this document . fig8 illustrates generally an example of portions of a system 800 that includes an implantable medical device 805 , which includes a heart sound sensor 810 , a heart sound detector 815 , and a processor 820 . in other examples , the heart sound detector 815 , or the processor 820 , can be an implantable component external to the implantable medical device 805 , or can be an external component . in this example , the heart sound sensor 810 is configured to sense a heart sound signal of a heart . the heart sound signal of the heart can include any signal indicative of a heart sound of the heart . illustrative examples of heart sounds include one or more than one of an s1 heart sound , an s2 heart sound , an s3 heart sound , an s4 heart sound , a regurgitant heart murmur , a stenotic heart murmur sound , and a coronary vascular blood turbulence sound . the heart sound sensor 810 can be any device configured to sense the heart sound signal of the heart , e . g ., an accelerometer , a microphone , etc . the heart sound sensor 810 can transduce the heart sound , such as into an electrical or optical “ heart sound ” signal that includes information about the sensed heart sound . in the example of fig8 , the heart sound detector 815 is coupled to the heart sound sensor 810 . in this example , the heart sound detector 815 is generally configured to detect at least one parameter indicative of an atrial filling pressure of the heart using the heart sound signal . in an example , the at least one parameter indicative of an atrial filling pressure includes at least one heart sound parameter indicative of an atrial filling pressure . in this example , the processor 820 is coupled to the heart sound detector 815 . the processor 820 is generally configured to compare the at least one parameter indicative of an atrial filling pressure to a threshold . in certain examples , the threshold can include a population - based threshold , a specified threshold , an adjustable threshold , an absolute threshold , or a permutation or combination of one or more than one threshold . in certain examples , where the threshold is an adjustable threshold , the adjustable threshold can include an automatically adjustable threshold , such as by the processor 820 in response to other information , e . g ., the posture signal , etc ., a user adjusted threshold , or a manufacturer adjusted threshold . in an example , the processor 820 compares the at least one parameter to the threshold to determine if the at least one parameter has crossed or is across the threshold . in certain examples , the at least one parameter has crossed the threshold if the at least one parameter is of a level that is equal to or below the threshold , or if the at least one parameter is of a level that is equal to or above the threshold . in other examples , the at least one parameter is across the threshold if the at least one parameter is of a level that is equal to or below the threshold , or if the at least one parameter is of a level that is equal to or above the threshold . in certain examples , the system 800 can operate in an ongoing fashion ( e . g ., continuously ), the system 800 can operate one or more than one time during one or more than one time period , e . g ., one or more than one time per hour , one or more than one time per day , etc ., or the system 800 can operate or cease to operate using a triggering event , including a user or patient input , or a physiological or other sensor input . fig9 illustrates generally an example of a system 900 that includes an implantable medical device 805 , which includes a heart sound sensor 810 , a heart sound detector 815 , a processor 820 , and a cardiac sensor 825 . in other examples , the heart sound detector 815 , or the processor 820 , can be an implantable component external to the implantable medical device 805 , or can be an external component . in this example , the cardiac sensor 825 is coupled to the heart sound detector 815 . the cardiac sensor is generally configured to sense a cardiac signal of the heart . the cardiac signal of the heart can include any signal indicative of the electrical or mechanical cardiac activity of the heart , e . g ., an electrocardiogram ( ecg ) signal , an impedance signal , an acceleration signal , etc . the cardiac sensor 825 can include any device configured to sense the cardiac activity of the heart , e . g ., an intrinsic cardiac signal sensor , such as one or more than one electrode or lead to sense one or more than one depolarization , a mechanical sensor , such as an impedance sensor or an accelerometer to sense one or more than one contraction . in the example of fig9 , the heart sound detector 815 is configured to detect at least one parameter indicative of an atrial filling pressure of the heart using the heart sound signal and the cardiac signal . in an example , the heart sound detector 815 receives the heart sound signal from the heart sound sensor 810 and receives the cardiac signal from the cardiac sensor 825 . in an example , the heart sound detector 815 uses information from the cardiac signal , such as to time or gate or otherwise assist detection of at least one heart sound , e . g ., s1 , s2 , etc . fig1 illustrates generally an example of a system 1000 including a processor 820 and a posture sensor 830 . in an example , the system 1000 includes an implantable medical device 805 , which includes the processor 820 and the posture sensor 830 . in other examples , the processor 820 , or the posture sensor 830 , can be an implantable component external to the implantable medical device , or can be an external component . in the example of fig1 , the posture sensor 830 is coupled to the processor 820 . the posture sensor 830 is generally configured to sense a posture signal indicative of a posture or an activity level of a patient . in an example , the processor 820 is configured to determine , set , or adjust a threshold using information from the posture sensor 830 . in another example , the processor 820 is configured to determine or adjust at least one parameter indicative of an atrial filling pressure of a heart using information from the posture sensor 830 . in certain examples , the posture sensor 830 includes at least one of an accelerometer , a pendulum - type device , a tilt switch , and a pressure sensor , or the posture sensor 830 includes a permutation or combination of one or more than one of the accelerometer , the pendulum - type device , and the pressure sensor . in an example , the processor 820 can determine the activity of the patient using the posture sensor 830 , e . g ., using information from the most current posture signal and at least one previous posture signal . fig1 illustrates generally an example of a system 1100 that includes a processor 820 and an alert module 835 . in an example , the system 1100 includes an implantable medical device 805 , which includes the processor 820 or the alert module 835 . in other examples , the processor 820 , or the alert module 835 , can be an implantable component external to the implantable medical device , or can be an external component . in the example of fig1 , the alert module 835 is coupled to the processor 820 . the alert module 835 is generally configured to alert a user or a patient using at least one parameter indicative of an atrial filling pressure of a heart . in certain examples , the alert module 835 is configured to alert the patient , such as by generating a noise or a vibration . in other examples , the alert module 835 is configured to alert the user or patient , such as by communicating a notification to the user or patient , e . g ., communicating a notification to the user or patient directly , or communicating a notification to the user or patient through some external device , such as an external programmer . in an example , the alert module 835 is configured to communicate with a remote user interface , such as the latitude configuration . in another example , the alert module 835 is configured to communicate to an external device , e . g ., an external repeater , which can be configured to communicate to an external repeater . in another example , the external repeater can be configured to communicate , such as by an e - mail or other communication , to the user . fig1 illustrates generally an example of a relationship between left atrial pressure ( lap ) 1205 and the amplitude of the third heart sound ( s3 ) 1210 . in an example , a data point 1220 includes an s3 amplitude value and an lap value . as is shown in fig1 , generally , as the lap 1205 increases , the s3 amplitude 1210 increases . in an example , using the data of fig1 , an s3 threshold 1215 can be set at 4 mg . in this example , an lap of 25 mmhg or higher can be detected with a sensitivity of 71 % ( 5 / 7 ) and a specificity of 90 % ( 2 / 20 ), or an lap of 20 mmhg or higher can be detected with a sensitivity of 64 % ( 7 / 11 ) and a specificity of 100 % ( 0 / 16 ). in another example , using the data of fig1 , the s3 threshold 1215 can be set at 2 mg . in this example , an lap of 10 mmhg or higher can be detected with a sensitivity of 75 % ( 15 / 20 ) and a specificity of 86 % ( 1 / 7 ). fig1 illustrates generally an example of a method 1300 including sensing a heart sound signal , detecting at least one parameter indicative of an atrial filling pressure , and generating an alert when the at least one parameter indicative of an atrial filling pressure crosses a threshold . in an example , the method 1300 can operate in an ongoing or continuous manner , the method 1300 can operate one or more than one particular time during one or more than one time period , e . g ., one or more than one time per hour , one or more than one time per day , etc ., or the method 1300 can operate or cease to operate using a triggering event , including a user or patient input . at 1305 , a heart sound signal is sensed . the heart sound signal can include any signal indicative of a heart sound of a heart . in an example , the heart sound signal can be sensed using the heart sound sensor 810 . at 1310 , at least one parameter indicative of an atrial filling pressure is detected . in an example , the at least one parameter indicative of an atrial filling pressure is detected using the heart sound signal . generally , the at least one parameter indicative of an atrial filling pressure can include at least one measurement , feature , characteristic , computation , or interval of the heart sound signal . in certain examples , the at least one measurement , feature , characteristic , computation , or interval of the heart sound signal includes at least one of an amplitude of a heart sound , a magnitude of a heart sound , a total energy of a heart sound , an interval between one heart sound feature and another heart sound feature , at least one heart sound characteristic normalized by at least one other heart sound characteristic , etc . ( e . g ., an amplitude or magnitude of s1 , an amplitude or magnitude of s2 , an amplitude or magnitude of s3 , an amplitude or magnitude of s4 , the existence of a split - s2 , a split - s2 time interval , a s1 - s2 time interval , a s2 - s3 time interval , a characteristic of s3 normalized by a characteristic of s1 , etc .). at 1315 , the method 1300 determines if the at least one parameter indicative of an atrial filling pressure has crossed , or is across , the threshold . in an example , at 1315 , the processor 820 determines if the at least one parameter indicative of an atrial filling pressure has crossed the threshold . in an example , if , at 1315 , the at least one parameter indicative of an atrial filling pressure crosses the threshold , then an alert is generated at 1320 . in another example , if , at 1315 , the at least one parameter indicative of an atrial filling pressure is of a level equal to or above the threshold , then an alert is generated at 1320 . in another example , if , at 1315 , the at least one parameter indicative of an atrial filling pressure is of a level equal to or below the threshold , then an alert is generated at 1320 . in certain examples , the at least one parameter indicative of an atrial filling pressure can be across the threshold for a certain duration ( e . g ., one or more than one cardiac cycle , one or more than one minute , one or more than one hour , one or more than one day , etc .) before the alert module is configured to generate an alert , or the at least one parameter indicative of an atrial filling pressure can cross the threshold for a certain duration ( e . g ., the at least one parameter crosses the threshold one time per day for 3 consecutive days , the at least one parameter crosses the threshold one time per day for 5 consecutive days , etc .) before the alert module is configured to generate an alert . generally , generating an alert using a population - based or absolute threshold allows the user or the processor 820 to set or adjust the threshold to detect a condition with a predefined specificity or sensitivity . this method can be advantageous over one that uses a threshold where the patient serves as their own control . in certain examples , by using a population - based threshold , a condition , e . g ., high left atrial filling pressure , can be detected with a very high specificity , e . g ., 86 %, 90 %, 100 %, etc . detecting a condition with a high specificity is generally advantageous due to a reduction in false - positives , among other reasons . conversely , setting or adjusting the threshold to detect a condition with a high specificity typically detects the condition with a lower sensitivity . in the example of fig1 , setting or adjusting the threshold to detect a condition with a specificity of 86 % detects the condition with a sensitivity of 75 %, setting or adjusting the threshold to detect a condition with a specificity of 90 % detects the condition with a sensitivity of 71 %, and setting or adjusting the threshold to detect a condition with a specificity of 100 % detects the condition with a sensitivity of 64 %. in another example , at 1315 , if processor 820 determines that the at least one parameter indicative of an atrial filling pressure has not crossed the threshold , then an alert is not generated , and the process flow returns to 1305 . fig1 illustrates generally an example of a method 1400 including sensing a heart sound signal , detecting at least one parameter indicative of an atrial filling pressure , sensing a posture signal , and generating an alert when the at least one parameter indicative of an atrial filling pressure crosses a threshold . at 1405 , a heart sound signal is sensed . the heart sound signal can include any signal indicative of a heart sound of a heart . in an example , the heart sound signal can be sensed using the heart sound sensor 810 . at 1410 , at least one parameter indicative of an atrial filling pressure is detected . in an example , the at least one parameter indicative of an atrial filling pressure is detected using the heart sound signal . in an example , the at least one parameter indicative of an atrial filling pressure is detected using the heart sound detector 815 . at 1411 , a posture signal is sensed . the posture signal can include any signal indicative of a posture or an activity level of a patient . typically , an atrial filling pressure can be more accurately determined , with a higher sensitivity or with a higher specificity , if the posture or the activity level of the patient is known . in an example , the threshold can be determined , set , or adjusted using information from the posture signal . generally , when the patient is lying in the supine , recumbent , prone , or other lying position , or when the patient is inactive or at rest , there exists less noise in the heart sound signal , and thus , a more accurate heart sound signal can typically be sensed . in an example , the threshold can be determined , set , or adjusted using information from the posture signal , e . g ., lowering the threshold during long periods of rest , raising the threshold during periods of increased activity , etc . in another example , the at least one parameter indicative of an atrial filling pressure can be determined or adjusted using information from the posture signal . generally , heart sound information can be dependent upon patient position . in an example , the heart sound signal or the at least one parameter indicative of an atrial filling pressure can be filtered , adjusted , or attained using information from the posture signal . at 1415 , the method 1400 determines if the at least one parameter indicative of an atrial filling pressure has crossed the threshold . in an example , at 1415 , the processor 820 determines if the at least one parameter indicative of an atrial filling pressure has crossed the threshold . in an example , if , at 1415 , the at least one parameter indicative of an atrial filling pressure crosses the threshold , then , at 1420 , an alert is generated . in another example , the at least one parameter indicative of an atrial filling pressure can be across the threshold for a certain duration ( e . g ., one or more than one cardiac cycle , one or more than one minute , one or more than one hour , one or more than one day , etc .) before the alert module is configured to generate an alert . in yet another example , the at least one parameter indicative of an atrial filling pressure can cross the threshold for a certain duration ( e . g ., the at least one parameter crosses the threshold one time per day for 3 consecutive days , the at least one parameter crosses the threshold one time per day for 5 consecutive days , etc .) before the alert module is configured to generate an alert . in another example , if , at 1415 , the at least one parameter indicative of an atrial filling pressure has not crossed the threshold , then an alert is not generated , and the process flow returns to 1405 . fig1 illustrates generally an example of a method 1500 including sensing a heart sound signal , sensing a cardiac signal , detecting at least one parameter indicative of an atrial filling pressure , and generating an alert when the at least one parameter indicative of an atrial filling pressure crosses a threshold . at 1505 , a heart sound signal is sensed . the heart sound signal can include any signal indicative of a heart sound of a heart . in an example , the heart sound signal can be sensed using the heart sound sensor 810 . at 1506 , a cardiac signal is sensed . the cardiac signal can include any signal indicative of a cardiac signal of the heart . in an example , the cardiac signal can be sensed using the cardiac sensor 825 . at 1510 , at least one parameter indicative of an atrial filling pressure is detected . in an example , the at least one parameter indicative of an atrial filling pressure is detected using the heart sound signal and the cardiac signal . in an example , the at least one parameter indicative of an atrial filling pressure is detected using the heart sound detector 815 . in another example , the at least one parameter indicative of an atrial filling pressure is detected using the processor 820 . generally , at 1510 , the at least one parameter indicative of an atrial filling pressure includes at least one measurement , feature , characteristic , computation , or interval between at least one cardiac signal feature and at least one heart sound signal feature . typically , the at least one cardiac signal feature can include at least one feature or component of an ecg signal , e . g ., at least one component of a p - wave , at least one component of a q - wave , at least one component of a r - wave , at least one component of a s - wave , at least one component of a t - wave , or any combination or permutation of features or components of the ecg signal . in certain examples , the at least one measurement , feature , characteristic , computation , or interval between at least one cardiac signal feature and at least one heart sound signal feature includes a systolic time interval ( sti ) ( e . g ., a total electromechanical systole ( q - s2 ), a pre - ejection phase ( pep ), a left - ventricular ejection time ( lvet ), an isovolumetric contraction time ( ict ), an interval between s1 and s2 ( s1 - s2 ), etc . ), a long q - s1 time interval , a r - s1 time interval , r - s2 interval , etc . at 1515 , the method 1500 determines if the at least one parameter indicative of an atrial filling pressure has crossed the threshold . in an example , at 1515 , the processor 820 determines if the at least one parameter indicative of an atrial filling pressure has crossed the threshold . in an example , if , at 1515 , the at least one parameter indicative of an atrial filling pressure has crossed the threshold , then , at 1520 , an alert is generated . in another example , the at least one parameter indicative of an atrial filling pressure can be across the threshold for a certain duration ( e . g ., one or more than one cardiac cycle , one or more than one minute , one or more than one hour , one or more than one day , etc .) before the alert module is configured to generate an alert . in yet another example , the at least one parameter indicative of an atrial filling pressure can cross the threshold for a certain duration ( e . g ., the at least one parameter crosses the threshold one time per day for 3 consecutive days , the at least one parameter crosses the threshold one time per day for 5 consecutive days , etc .) before the alert module is configured to generate an alert . in another example , if , at 1515 , the at least one parameter indicative of an atrial filling pressure has not crossed the threshold , then an alert is not generated , and the process flow returns to 1505 . in other examples , the alert can be generated using a threshold or other methods , including a statistical analysis , a standard deviation , or a constant false alarm - rate technique , such as is described in the co - pending , commonly assigned siejko et al . u . s . patent application ser . no . 11 / 276 , 735 , entitled “ physiological event detection systems and methods ,” filed mar . 13 , 2006 , now issued as u . s . pat . no . 7 , 713 , 213 , which is hereby incorporated by reference in its entirety . in the examples of fig8 - 15 , various examples , including sensing a heart sound signal , sensing a posture signal , sensing a cardiac signal , detecting at least one parameter indicative of an atrial filling pressure , determining if the at least one parameter indicative of an atrial filling pressure has crossed a threshold , generating an alert , operating or ceasing to operate a system , activating or deactivating a method , etc ., are disclosed . it is to be understood that these examples are not exclusive , and can be implemented either alone or in combination , or in various permutations or combinations . it is to be understood that the above description is intended to be illustrative , and not restrictive . for example , the above - described embodiments ( and / or aspects thereof ) may be used in combination with each other . many other embodiments will be apparent to those of skill in the art upon reviewing the above description . the scope of the invention should , therefore , be determined with reference to the appended claims , along with the full scope of equivalents to which such claims are entitled . in the appended claims , the terms “ including ” and “ in which ” are used as the plain - english equivalents of the respective terms “ comprising ” and “ wherein .” also , in the following claims , the terms “ including ” and “ comprising ” are open - ended , that is , a system , device , article , or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim . moreover , in the following claims , the terms “ first ,” “ second ,” and “ third ,” etc . are used merely as labels , and are not intended to impose numerical requirements on their objects . the abstract is provided to comply with 37 c . f . r . § 1 . 72 ( b ), which requires that it allow the reader to quickly ascertain the nature of the technical disclosure . it is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims . also , in the above detailed description , various features may be grouped together to streamline the disclosure . this should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim . rather , inventive subject matter may lie in less than all features of a particular disclosed embodiment . thus , the following claims are hereby incorporated into the detailed description , with each claim standing on its own as a separate embodiment .

US-201514594741-A

a new variety of verbena × hybrida is provided . the plant has rapid growth , particularly under nursery conditions , the habit is densely spreading , resulting from the many branches , multiple breaks from the new shoots and short internodes , and the flower is a deep red - rose color .

in order to more specifically identify the cultivar descriptive details are set forth hereinafter , along with related aspects of the plant which serve to distinguish the same , all colors being noted as compared with the royal horticultural society colour chart . the measurements and colors were recorded fron the mature plants grown in 6 inch diameter pots in the vicinity of dearing , ga . three fully developed units of each organ type were measured from each plant . leaves penultimate to leaves subtending flowers were selected for measurement . origin .-- this new cultivar was selected in rural mcduffie county , georgia on the homestead of lenzie archer in a cultured planting of verbena × hybrida . the planting resulted from a purchase of several seedling annual verbena × hybrida bedding plants from a local garden center no longer in business . with the advent of winter the other plants were killed by cold weather . only verbena × hybrida &# 34 ; l . archer &# 34 ; overwintered successfully and has proved to be perennial . these hybrid garden verbena × hybridas typically result from complex parentage involving verbena incisa , verbena peruviana , verbena phlogiflora , and verbena teucroides . general : a trailing perennial herb with tetragonal stems , softly pubescent in all parts , spreading to 5 to 6 feet in a single growing season . leaves .-- the mature leaf is toothed , ovate to ovate - oblong rugose , pubescent below especially along midvein , less pubescent above , and measures an average of 2 . 5 inches long by 1 . 5 inches wide . color .-- the upper leaf surface is dark green ( rhs 136a ) and the lower leaf surface is light green ( rhs 137b ). stems .-- covered with soft pubescence , creeping to ascending in habit and rooting at the nodes when contacting the soil surface . type .-- the flowers are held in spikes . the width of the inflorescence is 21 / 4 &# 34 ;. each individual flower is 3 / 4 &# 39 ; 7 / 8 &# 34 ; in width and 1 &# 34 ; in length with 5 / 16 &# 34 ; of that length being above the calyx . flowers are produced beginning in early spring , throughout summer and fall , and even during mild winter weather . color .-- the color of the flowers is a very distinct deep rose - red ( rhs 45b ). fruit .-- the flowers and fruit are similar in shape but differ in color and density . fruit is dry and enclosed in calyx . structure is same as inflorescence . verbena × hybrida &# 34 ; l . archer &# 34 ; has been grown in monoculture for 3 years without producing a seedling . cold hardiness .-- verbena × hybrida cultivars are listed in as cold hardy to zone 9 in the royal horticultural society dictionary of gardening . in tests conducted by dr . orville lindstrom of the university of georgia extension horticulture department the above - ground tissues of verbena × hybrida &# 34 ; l . archer &# 34 ; were found to be hardy to 7 degrees fahrenheit . in addition when grown in containers adjacent to verbena × hybrida &# 34 ; abbeville &# 34 ;, abbeville was killed by ambient temperatures of 8 degrees fahrenheit and verbena × hybrida &# 34 ; l . archer &# 34 ; survived undamaged . when grown in a garden adjacent to verbena × hybrida &# 34 ; carousel &# 34 ; and &# 34 ; silver ann &# 34 ;, verbena × hybrida &# 34 ; l . archer &# 34 ; survived the winter in an evergreen condition while the two former cultivars died . dr . lindstrom &# 39 ; s research finds the cold hardiness of verbena × hybrida &# 34 ; l . archer &# 34 ; to be comparable to that of verbena &# 34 ; homestead purple &# 34 ;. general observations : the color of the flower and cold hardiness distinguish this variety from other commercially available verbena × hybrida cultivars . the cultivar may be compared with known varieties along the following lines where observation were made on plants grown under similar conditions near dearing , ga . verbena canadensis &# 34 ; evelyn scott &# 34 ; has shorter , narrower leaves and a rose flower color while &# 34 ; l . archer &# 34 ; has a deep red - rose flower color and longer , broader leaves . verbena canadensis &# 34 ; homestead purple &# 34 ; has a purple flower color while &# 34 ; l . archer &# 34 ; has a deep red - rose flower color . verbena × hybrida &# 34 ; carrousel &# 34 ; has a white and purple flower color while &# 34 ; l . archer &# 34 ; has a deep red - rose flower color . &# 34 ; carousel &# 34 ; was killed at 7 degrees fahrenheit which did no harm to &# 34 ; l . archer &# 34 ;. verbena × hybrida &# 34 ; pink parfait &# 34 ; has a pink with white flower color while &# 34 ; l . archer &# 34 ; has a deep red - rose flower color . verbena × hybrida &# 34 ; defiance &# 34 ; is deep red in color but is hardy only to zone 9 . &# 34 ; l . archer &# 34 ; is hardy to zone 6 .

US-26546994-V

a spill - preventive pet - training apparatus and method for use in containing the lateral flow of liquid , such as urine , being applied to an absorbent pad at a volume and rate exceeding the absorption rate of the pad , by containing much of the liquid within an inner flexible ridge , and by slowing and containing any liquid that overtops the inner flexible ridge within an outer flexible ridge .

referring to fig1 and all figures generally , the spill - preventive pet - training method 100 and apparatus 10 are shown schematically . the spill - preventive pet - training apparatus 10 is meant to be placed on a floor for the pet to urinate upon , or for similar uses . the invention provides an impermeable base 20 which defines the horizontal coverage area of the invention . the impermeable base 20 can be made of plastic or rubber sheeting or similar materials , and can be made to be disposable or be durable and re - useable . embodiments of the invention can be made with various - shaped impermeable bases 20 , as illustrated in fig2 . the impermeable base 20 has a center portion and a perimeter portion , with the perimeter completely enclosing the center . the invention also provides concentric raised flexible ridges 30 arrayed upon the top of the impermeable base 20 . as illustrated in fig1 , the concentric raised flexible ridges can be placed directly on top of the base or can be placed such that an absorbent sheet , as disclosed below , can be placed in between . two concentric raised flexible ridges 30 , an inner ridge 31 and an outer ridge 32 , are provided in a preferred embodiment . additional ridges can also be provided , while still having an inner ridge and an outer ridge . the concentric raised flexible ridges 30 , when arrayed upon the top of the impermeable base 20 , will have a ridge height above the base . the concentric raised flexible ridges 30 can be made of plastic or rubber or similar materials , as with the impermeable base 20 . in some embodiments the concentric raised flexible ridges 30 can be incorporated into the impermeable base 20 either by attachment or by molding such ridges into the base during manufacture . in other embodiments , the concentric raised flexible ridges 30 can be provided with ridge spacers 35 , keeping the inner and outer ridges in proper relation to each other . the invention also provides an absorbent layer 40 arrayed upon the impermeable base 20 and under or between the ridges . the thickness of the absorbent layer material and the method of mounting it will determine a height relative to the impermeable base 20 of the top of the absorbent layer . in the center portion , inside the inner ridge 31 , the height of the installed absorbent layer should be lower than the ridge height of the inner ridge 31 . in other words , the top of the inner ridge 31 should be higher than the top of the installed absorbent layer 40 . the absorbent layer 40 can be made from a variety of materials , depending in part on whether a disposable or a re - useable unit is intended . the sheets of the absorbent layer 40 can be made of , for example , woven cloth of cotton or other natural fiber , of paper , or of woven , extruded , expanded , or otherwise made absorbent plastics . in embodiments having the absorbent layer 40 between the base and the ridges , a unitary absorbent sheet 43 is appropriate . in embodiments having the ridges mounted directly to the base , an inner absorbent sheet 41 and an outer absorbent sheet 42 , fitting to the exposed surface of the impermeable base 20 and leaving the concentric raised flexible ridges 30 uncovered , is appropriate . referring to fig3 , in use , the invention provides a central portion where the impermeable base 20 supports an inner absorbent sheet 41 and an outer absorbent sheet 42 , with an inner ridge 31 between and an outer ridge 32 at the outer perimeter . when liquid , such as urine , is applied to the central portion , the inner absorbent sheet 41 begins to absorb it , but if the volume and rate of application is greater than the capacity of the absorbent pad to absorb the liquid at its place of application and then wick the liquid to the unused areas of the pad , then the liquid will spread laterally , presenting a danger of spilling off the edge of the pad . such lateral spread of the liquid is blocked by the inner ridge 31 , which has a ridge height greater than that of the top of the inner absorbent sheet 41 . normally , the inner ridge 31 will block all of the spreading liquid , which will be fully absorbed by the inner absorbent sheet 41 . if the level of spreading liquid exceeds the ridge height of the inner ridge 31 , then the inner ridge may be overtopped . even in such an event , the inner ridge still blocks a portion of the spreading liquid , and the lateral velocity of the overtopping portion of the liquid is slowed by a vertical change of direction in pouring over the outer side of the inner ridge and other physical aspects of the overtopping . an outer absorbent sheet 42 is provided to absorb any such overtopping liquid , and an outer ridge 32 at the outside perimeter is provided to perform the same blocking action as performed by the inner ridge 31 . another embodiment of the invention provides a single ridge 31 . normally , a single ridge 31 will block all of the spreading liquid , which will be fully absorbed by the inner absorbent sheet 41 . an embodiment of the invention provides a fully disposable spill - preventive pet - training apparatus where the concentric flexible raised ridges 30 are integral to , and molded , embossed , or deposited into or onto the impermeable base 20 , made of a flexible impermeable material such as a plastic film , with an inner absorbent sheet 41 and an outer absorbent sheet 42 glued or otherwise attached to the impermeable base 20 . a variant of this embodiment provides a more durable and re - useable integrated impermeable base 20 and concentric flexible raised ridges 30 , and disposable and replaceable absorbent sheets . another embodiment of the invention provides a durable and re - useable concentric flexible raised ridges 30 assembly held in proper relation one to another by ridge spacers 35 . this assembly could be made of , for instance , silicone rubber that can be safely washed with hot water or steam . a durable and re - useable impermeable base 20 is also provided . in use , a disposable unitary absorbent sheet 43 is placed upon the impermeable base 20 , and the concentric flexible raised ridges 30 assembly is placed upon the absorbent sheet . optionally , the base and the ridges assembly can be provided with means of magnetically fastening to one another by embedded magnets or magnetic metal in each piece . yet another embodiment provides a durable and re - useable concentric flexible raised edges 30 assembly , as above , but provides a disposable impermeable base 20 , optionally integrated with an absorbent sheet . such assemblies of disposable impermeable plastic - backed absorbent sheets , such as pads used in healthcare facilities , are available . many changes and modifications can be made in the present invention without departing from the spirit thereof . i therefore pray that my rights to the present invention be limited only by the scope of the appended claims .

US-201614990166-A

a microwavable pad for heating food has a liquid absorbent to prevent liquid leakage in the event that the sealed thermoplastic envelope of the pad is ruptured . the method of forming the pad includes evacuating air from the thermoplastic envelope prior to sealing . the pad can be used alone or with a food cover to provide warmth and impart heat to food when the pad is placed in a container with the food .

the preferred form of the microwavable pad of the invention is shown in partial cross - sectional view in fig8 and includes a water impervious outer cover , a thermoplastic envelope containing a liquid - filled sponge that has been compressed to approximately forty percent of its original size , and a sheet of insulating material within the water impervious cover beneath the thermoplastic envelope . the sponge compression provides unique features to the device for use in a variety of applications , whereby , in the event of an inadvertent rupture of the envelope , the sponge will expand and absorb any liquid which may otherwise drain through the rupture and contact human skin causing burns or irritations or stain food covers , food or the like . the insulating material prevents heat from escaping downwardly away from food to be warmed . the preferred method of forming the therapeutic pad comprises placing a flexible thermoplastic envelope , such as may be formed from polyethylene , in a conventional vacuum - forming and heat - sealing cabinet . liquid is introduced into the envelope , a sponge also positioned therein . with the vacuuming device turned on , the air is pumped from the envelope ; consequently , as the envelope collapses , the sponge is compressed . once a sufficient vacuum has been drawn , such as twenty - four inches of hg ., as demonstrated on a vacuum gauge , the heat sealing elements are activated to permanently seal the envelope . it can then be placed with a sheet of insulating material into a rubberized covering and an exterior fabric cover for later microwaving and use in keeping food warm . the preferred method of the invention utilizes a container comprising a typical bread basket in which a cloth cover with a pocket for retaining the microwavable pad is placed . the pad is heated in a standard microwave oven for about three minutes , after which it is removed and placed , insulated side down , into the central pocket of the flexible cloth food cover . the food cover is then placed in the basket with the pad along the inside bottom surface . bread or the like is then placed in the basket , and the excess and ends of the cloth are folded over the bread , as typically done to keep the bread warm before and during meals . the pad will impart heat to the bread for several hours , usually much longer than the necessary time to consume most meals , even if the bread is left uncovered . turning now to the drawings , pad 10 , as shown in fig1 contains a liquid filled microwavable pad of the invention . the pad can be placed in a conventional microwave oven and heated for approximately five minutes . the pad is then removed and placed proximate food to provide warmth thereto . pad 10 is shown in fig2 in cross - sectional view , whereby cover 11 is formed from a cotton fabric and encloses sealed flexible plastic envelope 12 , which may be , for example , formed from polyethylene or other suitable and durable plastics . means 13 to absorb liquid is positioned within envelope 12 and in a compressed state , as will be hereinafter explained . means 13 consists of a synthetic nylon sponge , although other resilient , compressible absorbents may also be used , such as natural sponges or other synthetic or natural structures . as seen in fig2 means 13 is compressed to approximately forty percent of its normal size , and , as would be understood , if envelope 12 is ruptured , means 13 would attempt to recover to its normal , non - compressed configuration . water impervious covering 40 is shown in fig2 and 3 and may consist of cotton flannel / rubberized sheathing , a neoprene coated nylon sheeting , a natural rubberized sheeting or other similar combinations . these materials are conventional and are commonly used in hospitals and for incontinence uses on beds , chairs and other articles . their durability and high resistance to tearing and puncturing make them desirable ; thus , they have been found to provide superior water impervious coatings for microwavable pads . in fig3 combination vacuum and heat sealing device 14 is shown having a chamber lid 15 and control panel 16 for vacuum forming and heat sealing thermoplastic envelopes , such as envelope 12 shown in fig2 . device 14 is conventional and is sold throughout the food industry for vacuum packaging meats and other products . in forming a microwavable pad as presented herein , empty envelope 12 is filled with a suitable amount of liquid , such as a water solution or proprietary formula , and sponge 17 , as shown in fig4 a , is placed therein . as shown in fig4 b and 4c , sponge 17 is reduced in size as air is evacuated from collapsing envelope 12 , and , as would be understood in fig4 c , with sponge 17 substantially compressed once the vacuum pressure reaches the controlled level of , for example , 24 inches of hg ., envelope 12 is permanently heat sealed , maintaining sponge 17 in a compressed posture . thereafter , cover 11 can be applied thereto as desired . in the event the seal of envelope 12 is broken or in the event envelope 12 is ruptured at some surface point , air , as depicted by the arrow in fig5 will rush into envelope 12 allowing sponge 17 to expand and close off rupture 18 while absorbing any liquid that may attempt to drain therethrough . hence , with the rupture so protected and filled with sponge 17 , therapeutic pad 20 is safe for use in that it will not substantially cause injury , damage or staining . water - impervious , rubberized covering 40 is shown in fig5 surrounding envelope 12 to provide a more durable product . the aforementioned rubberized covering 40 may be formed from a cotton flannel , which is bonded to a natural or synthetic rubber , or may consist of nylon sheathing , which has been neoprene coated , as is well - known in the incontinence product art . also in fig5 liquid crystal temperature indicator 45 is shown positioned atop pad 20 . liquid crystal temperature indicating devices are old and have been used for many years to indicate temperatures and temperature changes . temperature indicator 45 is affixed by an adhesive or by other means to rubberized covering 40 to assist one in determining the temperature and the time required to bring pad 20 to its desired temperature level in a microwave oven during heating . thermochromic liquid crystal temperature indicator 45 consists includes a transparent , adhesive - backed base for attachment to covering 40 . affixed to the base is a polymer pouch for containing liquid crystals . various temperature indicia are available , which may include a black background top surface at room temperature with white letters that indicate high , medium and low temperatures . in fig6 conventional food container 30 is shown consisting of a bread basket . placed within food container 30 is flexible cloth food cover 31 , which is dimensioned in excess of the interior of container 30 . in fig7 flexible cloth food cover 31 is shown removed from food container 30 and , as seen , is rectangular and includes central pocket 32 for microwavable pad 33 , as seen in fig8 . fig8 also shows microwavable pad 33 in partial cross - section . sealed , flexible plastic envelope 12 , which is the same as in fig2 is placed above a layer of insulating material 41 inside water impervious covering 40 . insulating material 41 may be , for example , a 1 / 4 &# 34 ; thick layer of polystyrene foam and is approximately the same width as plastic envelope 12 . cloth food cover 31 is formed from a conventional textile fabric sheet , such as made from cotton , a cotton blend , a synthetic or a syntheic blend , and pocket 32 of the same fabric is sewn thereto , which provides a means for easily retaining microwavable pad 33 . the size of cover 31 is in excess of the interior dimensions of food container 30 to allow food therein to be surrounded and covered along the sides and top . in fig9 food 34 , here seen consisting of conventional dinner rolls , has been placed in food container 30 and has been covered by excess ends 35 , 35 &# 39 ; of food cover 31 . if desired , a lid ( not shown ) can also be placed on food container 30 to hold in more heat and moisture . the method of the invention includes removing microwavable pad 33 from pocket 32 and placing it in a microwave oven for approximately five minutes on a high temperature setting . pad 33 is then removed from the microwave oven and placed , insulated side down , within pocket 32 , whereupon food cover 31 is then positioned along the bottom of food container 30 with excess ends 35 , 35 &# 39 ; extending therefrom , as seen in fig6 . thereafter , rolls 34 or other food objects are placed on top of pocket 32 within container 30 , and ends 35 , 35 &# 39 ; are folded over rolls 34 ; as a result , heat is imparted from pad 33 to keep rolls 34 at a warm , appetizing temperature . other breads or foods may likewise be warmed or held warm for extended periods of time ( several hours ) without undue inconvenience . the illustrations and examples provided herein are for explanatory purposes only and are not intended to limit the scope of the appended claims .

US-51729395-A

an ultrasonic skin pigment application device where the device moves the needle applying the pigment at an ultrasonic rate . the device can be a self contained , self - powered , or externally powered . the invention may also include replaceable needles , and or a pigment reservoir . the device may also have adjustments for stroke length , stroke force , and stroke rate . the needle moving mechanism may be either an ultrasonic linear piezo drive or solenoid type drive mechanism or actuator .

referring first to fig1 , that shows an isometric view of the invention showing one embodiment of the components . this figure shows a general view of the components that will be described in more detail with the additional figures . fig1 shows the invention in a self - contained version where all the components are enclosed in a single handheld unit . other embodiments are contemplated that include an external power supply and or control electronics . a single two or three conductor wire connects from the external power supply and control electronics to the handheld ultrasonic pigment marking device . the figure includes a rear enclosure member 10 that contains a power source . the power source in this embodiment is with two “ c ” batteries item 12 . the batteries are pushed into the positive contact terminal 32 with spring 14 located in the back of the rear enclosure member . the rear enclosure member is threaded into the body of the main body 20 of the pigment application device with threads from the rear enclosure member 16 and threads located in the main body 26 . an insulator 28 separates the rear - threaded section of the main body from the control electronics . in the preferred embodiment , the control electronics 30 are contained in the main body . one possible schematic for the control electronics is shown in fig6 . the control electronics are shown enclosed within the main body , but the control electronics may be located external to the pigment application device . locating the control electronics will reduce the weight of the pigment device . another embodiment may include a foot - activated control or switch so the operator can keep both hands free to use the pigment application device . connection to the ground of the power supply is made by item 34 that provides both a grounding connection and keeps the electronics biased to one side of the housing . the electronics can have multiple adjustments for needle force , stroke and rate . these adjustments can be performed using switch 72 and or an adjustable knob or dial 70 . the functions and controls will be explained in more detail in fig6 . the electronics are connected to an ultrasonic linear drive mechanism or actuator 40 . two types of ultrasonic linear drive actuators are shown in fig2 and fig3 . the side of the main body opposite the batteries has a tapered section that is threaded 25 into a mating threaded section 55 of a replaceable front enclosure 50 . the back end 62 of the needle 60 is inserted into the ultrasonic linear drive at item 42 . the needle is held against the ultrasonic linear drive actuator with spring 44 . the spring keeps the needle retracted against the ultrasonic linear drive . the front enclosure member 50 is shown as a replaceable housing , but the housing may be a permanent part of the housing . at the end of the front enclosure member a small opening 54 , that guides the tip of the needle 64 . pigment may be added into the front enclosure 80 . as the needle retracts into the front enclosure , a small amount of pigment is added to the needle . as the needle moves out of the front enclosure , the pigment is drawn from the front enclosure and pushed from the needle under the surface of the skin . to eliminate the trouble of cleaning and sterilizing the needle , the needle and front enclosure can be removed and discarded . a new needle can then be inserted , pigment added to a new front enclosure , and the front enclosure screwed onto the main body . this allows a fast and sterile change of pigment . referring now to fig2 , that provides a detailed drawing of one embodiment of the needle drive mechanism . in this embodiment , the drive mechanism is a linear piezo drive mechanism . the linear piezo drive 40 is shown inside the main body 20 . the control electronics are shown connected to the linear piezo drive . a number of companies manufacture linear piezo drive motors such as national instruments and physik instruments . an embodiment of the linear piezo drive is shown where the piezo elements 46 push from back of the piezo drive 49 against a pyramid shaped structure 48 . as the piezo elements expand , they push in on the sides of the pyramid structure , the motion is amplified and the needle is pushed forward . the needle 60 is threaded 62 into the linear piezo drive 42 . the needle is held against the ultrasonic linear drive with spring 44 . the spring keeps the needle retracted against the ultrasonic linear drive . a washer 61 provides a flat surface for the spring to keep the end of the linear piezo drive in the retracted position and the needle retracted within the front enclosure . referring now to fig3 , that provides a detailed drawing of an alternative linear needle drive mechanism 40 . in this embodiment , the drive mechanism is a ferrous core 43 and an inductive drive mechanism 47 . the linear drive 40 is shown inside the main body 20 . the control electronics 30 are shown connected to the core and inductive drive . a number of companies manufacture linear solenoid drives of this type . the core is a thin material to reduce mass or inertia that is being moved . the inductive drive consists of multiple turns of wire . the inductive drive energizes and creates a magnetic field that pushes the core out of the inductive field . the needle 60 is connected to the ferrous core 43 . in this figure , an external power supply is connected to the control electronics at jack 15 . switch 72 turns the invention on and off . in this embodiment the needle is moved at a fixed rate , stroke . referring now to fig4 that shows a quad or four - tip needle 60 . the needle has a rear section 62 that connects is retained or screws into the linear drive mechanism . the main body of narrows in steps to the quad needle assembly as shown in this figure , but the body may taper to the quad needle assembly . the quad needle 66 shows a collection of four needle tips , but the needle may be as few as one point to as many as four or more points that allow application of the pigment at a higher rate . referring now to fig5 that show a block diagram of the electrical drive mechanism . this block diagram can be used for either a hardwired logic as shown and described in fig5 , or as a microprocessor controller drive logic where the microprocessor controls the rate , force , position , and or stroke of the needle . the power source 100 provides power to both the oscillator 110 and the power amplifier 120 with connection 105 . in the preferred embodiment the power source is from batteries . the oscillator provides a square , sine , saw , triangular or other wave shape . the frequency of the oscillation may be an adjustable or fixed frequency . the oscillation generator many be provided by a micro - controller or microprocessor that provides a digital or analog output for the frequency of oscillation . the oscillation generator is connected to the power amplifier 120 with connection 115 . the power supply can output a fixed or variable amount of power with connection 125 to the needle drive mechanism 130 . the needle drive mechanism can be a variety of types that output a linear motion . in the preferred embodiment , the output is a piezo linear drive mechanism that moves the needle out and back . strain and or position gauges may be placed on the needle drive mechanism to provide feedback regarding the position and or force of the needle . referring now to fig6 that show a schematic circuit diagram of the electrical drive mechanism . the schematic consists of a user interface portion items 240 , 330 and 350 , frequency generator 300 , and a linear drive 380 . the analog portion can alternately be performed with a microprocessor programmed to read adjustable inputs from the user interface , and make the required outputs and commands to the drive portion of the circuit . in this embodiment , the schematic shows a wall plug 200 connected to transformer 210 but the power source could be batteries contained within the pigment application device . the transformer is a step down transformer that provides a lower voltage . the output of the transformer goes into diodes 220 of a full wave bridge . the full wave bridge provides converts the sine wave output from the transformer into a ground and positive voltage . the voltage is filtered with capacitor 230 . switch 240 allows the power to the circuit to be turned on and off . the voltage then is regulated with the voltage regulator 250 to a fixed voltage . the regulator in this embodiment is a five - volt regulator . the output from the regulator is filtered using filtering capacitors 260 and 270 . the frequency generator 300 is connected to the regulated voltage 280 and ground connection 290 . the frequency generator includes a number of components resistor 320 and capacitor 310 that allow the range of adjustment for the frequency to be set . variable resistor 330 allows the adjustment of frequency . the selected components allow for an output frequency from about one thousand cycles per second to about 20 thousand cycles per second . the frequency is available at item 340 . this output is then sent into variable resistor 350 that sets the amount of signal that will be amplified . this adjustment sets the amount of force , power or energy that will be provided to the linear drive 380 . the signal from the variable resistor 350 goes into the power amplifier 360 that provides the power for the linear drive that moves the needle . the output from the power amplifier is filtered with capacitor 370 and then connected to the linear drive 380 . in the schematic , the linear drive is a piezo linear drive , but any type of linear drive system will work that provides linear motion from the output of the power amplifier . thus , specific embodiments and applications for an ultrasonic pigment application device have been disclosed . it should be apparent , however , to those skilled in the art that many more modifications besides those described are possible without departing from the inventive concepts herein . the inventive subject matter , therefore , is not to be restricted except in the spirit of the appended claims .

US-85772904-A

attachable and detachable footwear components are disclosed which contribute to the development of certain muscles and tendons in the lower body , including the gluteus maximus , gluteus medius , sartorius , plantaris , and the like . the disclosed footwear components are inflatable in some embodiments and made in the preferred embodiment of flexible elastomeric polymers . the disclosed components detach to and from the soles of common footwear commonly available in the market , and comprise a distal ball , a proximal ball , and some embodiments , one or more mid - balls . when affixed to standard footwear , the disclosed components destabilize the foot longitudinally and laterally , and plyometrically stress tendons and muscles in the legs of a wearer , toning and strengthening the wearer &# 39 ; s legs with time .

reference throughout this specification to “ one embodiment ,” “ an embodiment ,” or similar language means that a particular feature , structure , or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention . thus , appearances of the phrases “ in one embodiment ,” “ in an embodiment ,” and similar language throughout this specification may , but do not necessarily , all refer to the same embodiment . furthermore , the described features , structures , or characteristics of the invention may be combined in any suitable manner in one or more embodiments . in the following description , numerous specific details are provided . one skilled in the relevant art will recognize , however , that the invention may be practiced without one or more of the specific details , or with other methods , components , materials , and so forth . in other instances , well - known structures , materials , or operations are not shown or described in detail to avoid obscuring aspects of the invention . fig1 a is a top elevational perspective view of a detachable convex plyometric athletic trainer 100 in accordance with the present invention . the detachable convex plyometric athletic trainer 100 comprises a shoe 102 , a shoe sole 104 , a distal ball 106 , a proximal ball 108 , a top surface 110 a , a top surface 110 b , an outer surface 112 a , and an outer surface 112 b . the shoe 102 is well - known to those of skill in the art . the shoe 102 may comprise any kind of shoes well - known to those of skill in the art , including running , track , hiking , climbing , bowling , casual , flip - flops , dress and the like . the shoe 102 comprises a distal end and a proximal end . the distal end of the shoe 102 comprises the forward half of the shoe 102 furthest away longitudinally from the heel of the foot of the wearer and under the ball of the foot of the wearer . the proximal end of the shoe 102 comprises the rearward half of the shoe 102 situated under the heel of the foot of the wearer and further away longitudinally from the ball of the foot of the wearer . the longitudinal axis of the shoe 102 runs from the proximal end of the shoe to the distal end , while the lateral axis of the shoe 102 runs from the inside edge of the shoe 102 to the outside edge . the inside edge of the shoe 102 is the lateral edge of the shoe 102 in closest proximity to a sister shoe being worn by the wearer on the opposite foot . the shoe sole is well - known to those of skill in the art . the shoe sole 104 comprises a top side , an underside , oppositely disposed lateral edges including an inside lateral edge and an outside lateral edge , and two or more ground - engaging components on the underside , the ground - engaging components being approximately disposed in a common plane , with a longitudinal axis extending from the proximal end of the shoe to the distal end of the shoe , and with a lateral axis extending from the inside lateral edge to the outside lateral edge . in some embodiments of the present invention , the shoe sole 104 is made of polymers or various species of rubber , in other embodiments the shoe sole 104 is made of leather or other pliable and durable materials . the distal ball 106 , in the shown embodiment , comprises a roughly half - spherical ( or hemispherical ), pod - like , dome - like , convex component . the distal ball 106 attaches and detaches below the distal end of the shoe sole 104 . the distal ball 106 , or hemisphere 106 , is attached to the sole of a piece of footwear , and comprises a lower surface ( i . e . an outer surface 112 b ) and a top surface 110 a ; the distal ball 106 comprising at least one convexly rounded projection on the lower surface ( which is some cases spans the lower surface 112 b ) as viewed in a frontal plane cross - section when the distal ball 106 is attached to the shoe in an upright position , said convexity being determined relative to the shoe sole . in alternative embodiments , the distal ball 106 and / or the proximal ball 108 may be concave . the distal ball 106 is affixed to the underside of the shoe sole 106 . in some embodiments , the distal ball 106 is detachable using screws , rails , clamps or rubbers cement . the distal ball 106 is convex in shape and comprises an outer surface 112 b of a pliable durable non - porous polymer material , wherein the width of the proximal ball is more than half the distance between the inside lateral edge and the outside lateral edge . the distal ball 106 comprises an outer surface 112 b , or shell , made of rubber , leather and / or another pliable and durable material which completely encompasses the distal ball 106 . the lower surface 112 b of the distal ball 106 , and the top surface 110 b of the distal ball 106 , together define a recess within the distal ball 106 . in some embodiments of the present invention , this recess is filled with compressed air . in some embodiments of the present invention , the distal ball 106 is inflatable by the wearer using means known to those of skill in the art . in other embodiments of the present invention , the distal ball 106 is filled with one of viscoelastic polyurethane foam and silicone gel . the compressed air may comprise ambient air , or any combination of one or more elements in a gaseous state . in still further embodiments , the compressed air may comprise , or be substituted for , elements , or a mixture of elements , in semi - solid , solid , or liquid state , in a liquid state of any measurably viscosity . the outer surface of the distal ball 106 , in some embodiments , comprises an impermeable and flexible exterior surface with a hollow core interiorly isolated atmospherically from ambient air and filled with one of air , water , noble gases , viscoelastic polyurethane foam , and permeable , silicone gel . the proximal ball 108 , in the shown embodiment , comprises a roughly half - spherical , dome - like or hemispherical , convex component . the proximal ball 108 attaches and detaches below the proximal end of the shoe sole 104 . the proximal ball 108 is affixed to the underside of the shoe sole 106 . in some embodiments , the proximal ball 108 is detachable using screws , rails , clamps or rubbers cement . in other embodiments , the proximal ball 108 , like the distal ball 106 , is attachable and detachable using velcro , adhesives , straps , ties , hooks , bands , and snaps ( snaps being metal buttons , one which “ snaps ” into the other ). in one embodiment of the present invention , between one and ten straps lined on one side with velcro ® are each affixed to either the lower surfaces 112 a - b or the top surfaces 110 a - b of the distal ball 106 and the proximal ball 108 . the velcro lining may be velcro hook lining , or velcro hoop lining . in either case , the shoe 102 is lined with opposing hook or hoop velcro lining for detachably receiving the straps and thus detachably and attachably receiving the balls 106 , 108 to which the strap are coupled . in various embodiments of the present invention , one or more plastic or metal rings are affixed to either side of the outer surfaces 112 a - b using means well - known to those of skill in the art . in some embodiments , velcro straps are removably inserted through these rings and strapped over the shoe 102 to secure the balls 106 , 108 to the shoe 102 before a user commences physical training activities . in various embodiments of the present invention , the rings are attachable and detachable . the rings may be fashioned in any color , and may be designed to look fashionable , or to complement colors and / or shapes featured on the balls 106 , 108 and / or the shoe 102 . in other embodiments of the present invention , the rings are substituted for fasteners , such as cam fasteners comprising a cam lever for gripping knurled tie - downs , or over - center fasteners , or ratchet fasteners . in those embodiments comprising fasteners , tie - downs strapped over the top of the shoe 102 are fastened through the fasteners and used to secure the balls 106 , 108 to the shoe in much the same fashion that tie - downs and their accompanying hardware are used to secure cargo and freight to truck beds . the proximal ball 108 is convex in shape and comprises an outer surface of a pliable durable non - porous polymer material , wherein the width of the proximal ball is more than half the distance between the inside lateral edge and the outside lateral edge . the proximal ball 108 comprises an outer surface , or shell , made of rubber , leather and / or another pliable and durable material which completely encompasses the proximal ball 108 . the proximal ball 108 defines a recess within the distal ball 106 . in some embodiments of the present invention , this recess is filled with compressed air . in some embodiments of the present invention , the proximal ball 108 is inflatable by the wearer using means known to those of skill in the art . in other embodiments of the present invention , the proximal ball 108 is filled with one of viscoelastic polyurethane foam and silicone gel . the outer surface of the proximal ball 108 , in some embodiments , comprises an impermeable and flexible exterior surface with a hollow core interiorly isolated atmospherically from ambient air and filled with one of air , water , noble gases , viscoelastic polyurethane foam , and permeable , silicone gel . in some embodiments of the present invention , the diameter of the proximal ball 108 is ten to forty percent less than the diameter of the distal ball 106 . in other embodiments , the diameter of the distal ball 106 is ten to forty percent less than the diameter of the proximal ball 108 . in other embodiments , the diameter of the proximal ball 108 is less than the diameter of the distal ball 106 , or vice - versa . the distal ball 106 and proximal ball 108 , when attached to the shoe sole 104 and used by a wearer , destabilize muscles and tendons in the lower extremities , and strengthen those muscles and tendons , including the gluteus maximus , gluteus medius , gastrocnemius , soleus , fibularis longus , fibularis brevis , plantaris , flexor hallucis longus , medial malleolus , adductor magnus , semitendinosus , sartorius , plantaris , and the like . because the proximal ball 108 and the distal ball 106 have convex outer surfaces , they do not provide lateral stability to wearer of the present invention . the present invention , thus , forces the user to engage in increased plyometric exercise and causes increased strain and strengthening of muscles and tendons in the lower extremities . in various embodiments of the present invention , the balls 106 , 108 may not be hemispherical , but may be shaped in the form of any other geometric shape incorporating one or more non - planar facets , including polyhedral , toroidal polyhedral , spherical cap , and even egg - shaped . in various embodiments of the present invention , the balls 106 , 108 may be shaped in the form of any one half of the these geometric shapes . fig1 b is a top elevational perspective view of a detachable convex plyometric athletic trainer 120 in accordance with the present invention . the detachable convex plyometric athletic trainer 120 comprises a shoe 102 , a shoe sole 104 , a distal ball 106 , and a proximal ball 108 . the shoe 102 , shoe sole 104 , distal ball 106 , and proximal ball 108 are substantially described above in relation to fig1 a . fig1 b shows a plyometric athletic trainer 120 in its attached configuration , wherein the distal ball 106 and the proximal ball 108 are not detached from the shoe 102 and shoe sole 104 . the distal ball 106 and the proximal ball 108 are attached , in the shown embodiment , using rubber cement well - known to those of skill in the art to the shoe sole 104 , and are roughly centered laterally . fig1 c is a lower elevational perspective view of a detachable convex plyometric athletic trainer 140 in accordance with the present invention . the detachable convex plyometric athletic trainer 140 comprises a shoe 102 , a shoe sole 104 , a distal ball 106 , a proximal ball 108 , a distal screw 142 , a proximal screw 144 , a distal screw receiver 144 , and proximal screw receiver 146 . the shoe 102 , shoe sole 104 , distal ball 106 , and proximal ball 108 are substantially described above in relation to fig1 a - 1b . fig1 c shows a plyometric athletic trainer 140 in its detached configuration , wherein the distal ball 106 and the proximal ball 108 are detached from the shoe 102 and shoe sole 104 . the distal ball 106 and the proximal ball 108 ( together the “ balls 106 , 108 ”) are attachable , in the shown embodiment , using two screws 142 , 144 which traverse the balls 106 , 108 vertically and secure inside the shoe sole 104 . the distal screw 142 and the proximal screw 144 comprise screws well known to those of the skill in the art . in the shown embodiment , the screws 142 , 144 exceed the height of the balls 106 , 108 . the distal screw receiver 146 and the proximal screw receiver 148 comprise holes within the shoe sole 104 meant to receive and secure the screws 142 , 144 . in some embodiments , the receivers 146 , 148 comprise studs . screw receivers are well - known to those of skill in the art . in various embodiments of the present invention , the interior , or core of the balls 106 , 108 is solid and comprised of the same material as the outer surface 112 . in various other embodiments , the core is an extension of the outer surface 112 or top surface 110 . in fig1 c , the balls 106 , 108 are attached using the screws 142 , 144 to the shoe sole 104 . in other embodiments , the screws 142 , 144 attach the balls 106 , 108 to the shoe sole 104 at , or closer to , the perimeter of the balls 106 , 108 . any number of screws 106 , 108 may be used to secure the distal ball 106 and the proximal ball 108 . in various embodiments of the present invention , the top surface 110 of the balls 106 , 108 may not be planar or substantially planar , but may instead be curved , convex , concave , or otherwise non - planar such that the top surface 110 contours the lower surface of the sole 104 of the shoe 102 . fig1 d is a lower elevational perspective view of a detachable convex plyometric athletic trainer 160 in accordance with the present invention . the detachable convex plyometric athletic trainer 160 comprises a shoe 102 , a shoe sole 104 , a distal ball 106 , a proximal ball 108 , a distal screw 142 , and a proximal screw 144 . the shoe 102 , shoe sole 104 , distal ball 106 , proximal ball 108 , distal screw 142 , and proximal screw 144 are substantially described above in relation to fig1 a - 1c . the balls 106 , 108 may comprise a shock absorber mounted within one or more of the balls 106 , 108 to absorb shock , or impact to the balls 106 , 108 , exerted along the longitudinal axis . fig1 d shows the present invention 160 in its assembled configuration . fig2 is a lower elevational perspective view of a detachable convex plyometric athletic trainer 200 in accordance with the present invention . the detachable convex plyometric athletic trainer 160 comprises a shoe 102 , a shoe sole 104 , a distal ball 106 , a proximal ball 108 , a distal rail 202 a , distal rail 202 b , a proximal rail 204 a , a proximal rail 204 b , a distal receiving rail 206 a , a distal receiving rail 206 b , a proximal receiving rail 208 a , and proximal receiving rail 208 b . the shoe 102 , shoe sole 104 , distal ball 106 , and proximal ball 108 are substantially described above in relation to fig1 a - 1d . the distal ball 106 and the proximal ball 108 , in the shown embodiment , comprise rails 202 a - b , 204 a - b disposed above the balls 106 , 108 . the distal rails 202 a - b and proximal rails 204 a - b ( the “ rails 202 a - b , 204 a - b ”), in the shown embodiment , run parallel with the longitudinal axis of the present invention . in other embodiments , the rails 202 a - b , 204 a - b run approximately perpendicular to the longitudinal axis . the distal rails 202 a - b slide across and into and lock within the distal receiving rails 206 a - b . the proximal rails 204 a - b slide into and lock within the proximal receiving rails 208 a - b using means well - known to those of skill in the art . in some embodiments of the present invention , the distal ball 106 optionally connects to the proximal receiving rails 208 a - b and is interchangeable with the proximal ball 108 . the diameter of the proximal ball 108 may differ from the diameter of the distal ball 106 . thus , the present invention teaches multiple configurations of the present invention . in various embodiments of the present invention , either the distal ball 106 or the proximal ball 108 may be attached detachably below the shoe 102 without the other ball . the balls 106 , 108 may be detachably attached to the shoe 102 using velcro , adhesives , screws , clamps , straps , ties , hooks , bands , or snaps . when attached with velcro , the planar top surface of the ball 106 , 108 comprises a layer of velcro hooks or loops , made of nylon or polyester , which connect with an alternate layer of hooks or loops affixed to the sole of the shoe 102 . adhesives are well - known to those of skill in the art . in various embodiments of the present invention , the balls 106 , 108 are glued to the shoe 102 . in some of these embodiments , the balls 106 , 108 can be removed by dissolving the adhesives . the balls 106 , 108 may be clamped to the sole of the shoe 102 using clamps , clips , clasps , buckles , tie - down straps ( including loop straps and two - piece straps ), webbing , or other fastening devices affixed to the outer surface of the balls , 106 , 108 using means well - known to those of skill in the art , including marman clamps , hose clamps , set screws , turn buckles , and the like . straps , ties , and bands may be affixed to the balls 106 , 108 and / or the shoe 102 for detachably attaching the balls 106 , 108 to the shoe 102 . snaps are well - known to those of skill in the art , and described above . the balls 106 , 108 may comprise a hollow interior , which may be accessible through a door hingedly connected to the outer surface 112 a - b of the balls 106 , 108 , or hingedly connected to the top surface 110 a - b . the hollow interior may be used to house one or more electrical devices from the group consisting of a gps tracker , an odometer , light emitting diodes ( leds ), lights ( color coded , in some embodiments , to match the shoe 102 and / or the balls 106 , 108 ), batteries , and a step counter . the hollow interior may also be used by a wearer to provide user storage , or may be filled with one or more of viscoelastic polyurethane foam and silicone gel , or a non - silicone gel . fig3 a is a side perspective view of a detachable convex plyometric athletic trainer 320 in accordance with the present invention . the detachable convex plyometric athletic trainer 300 comprises a shoe 102 , a shoe sole 104 , a distal ball 106 , a proximal ball 108 , a distal screw 142 , and a proximal screw 144 . the shoe 102 , shoe sole 104 , distal ball 106 , and proximal ball 108 are substantially described above in relation to fig1 a - 3a . the shown embodiment illustrates that , in some embodiments of the present invention , the distal ball 106 and the proximal ball 108 may attach to a shoe sole 104 with a non - planar underside , such as a toning shoe . in the shown embodiment , the shoe sole 104 comprises a convex underside , and the distal ball 106 and the proximal ball 108 comprise concave upsides meant to conform to the shoe sole 104 . fig3 b is a side perspective view of a detachable convex plyometric athletic trainer 340 in accordance with the present invention . the detachable convex plyometric athletic trainer 320 comprises a shoe 102 , a shoe sole 104 , a distal ball 106 , a proximal ball 108 , a distal screw 142 , and a proximal screw 144 . the shoe 102 , shoe sole 104 , distal ball 106 , and proximal ball 108 are substantially described above in relation to fig1 a - 3a . the shown embodiment shows balls 106 , 108 conjoined to the shoe sole 104 . fig4 a is a bottom perspective view of a detachable convex plyometric athletic trainer 400 in accordance with the present invention . the detachable convex plyometric athletic trainer 400 comprises a shoe sole 104 , a distal ball 106 , and a proximal ball 108 . the shoe sole 104 , distal ball 106 , and proximal ball 108 are substantially described above in relation to fig1 a - 3b . the balls 106 , 108 may be multicolored . the colors of the balls 106 , 108 may be indicative of the height , and consequent degree of destabilization , of the balls 106 , 108 . the colors of the balls 106 , 108 may alternatively be indicative of the pressure of the inflated air within the balls 106 , 108 , and consequent degree of destabilization imparted to a wearer by the balls 106 , 108 . in the shown embodiment , the distal ball 106 is ovoid in shape from the bottom perspective . in alternative embodiments of the present invention , either or both the distal ball 106 and the proximal ball 108 may be ovoid in shape from this perspective view . fig4 b is a bottom perspective view of a detachable convex plyometric athletic trainer 420 in accordance with the present invention . the detachable convex plyometric athletic trainer 400 comprises a shoe sole 104 , a distal ball 106 , a proximal ball 108 , concentric tread 422 , and broken tread 424 . the shoe sole 104 , distal ball 106 , and proximal ball 108 are substantially described above in relation to fig1 a - 4a . the proximal ball 108 and / or the distal ball 106 may comprise broken tread and / or concentric tread disposed on the convex outer surface of the balls 106 , 108 . fig4 c is a bottom perspective view of a detachable convex plyometric athletic trainer 440 in accordance with the present invention . the detachable convex plyometric athletic trainer 400 comprises a shoe sole 104 , a distal ball 106 , a proximal ball 108 , broken rotating tread 442 , and half - circular tread 444 . the shoe sole 104 , distal ball 106 , and proximal ball 108 are substantially described above in relation to fig1 a - 4b . the proximal ball 108 and / or the distal ball 106 may comprise half - circular tread and / or broken rotating tread disposed on the convex outer surface of the balls 106 , 108 . in some embodiments of the present invention , the balls 106 , 108 comprise a gps locator , powered by energy generated from turbine activated by the compression of the one or more of the distal ball 106 and the proximal ball 108 . this feature allows parents , children , spouses , and others to track the location of wearers of the present invention as they run through forested or secluded areas perceived to be higher in danger . the present invention may be embodied in other specific forms without departing from its spirit or essential characteristics . the described embodiments are to be considered in all respects only as illustrative and not restrictive . the scope of the invention is , therefore , indicated by the appended claims rather than by the foregoing description . all changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope .

US-89026310-A

this invention discloses a method of treating cholera infection in a human by administering an effective amount of 1 , 5 - dideoxy - 1 , 5 - imino - d - glucitol or a derivative thereof .

while the specification concludes with claims particularly pointing out and distinctly claiming the subject matter regarded as forming the invention , it is believed that the invention will be better understood from the following illustrative detailed description taken in conjunction with the accompanying drawings in which : fig1 in two parts a and b , shows by autoradiographic visualization the effects on glycolipid biosynthesis in hl - 60 cells that were metabolically labelled with [ 14 c ] palmitic acid , fig1 a : in the presence of 0 . 5 mm n - butyl deoxynojirimycin (+ nb - dnj ) or fig1 b : absence of nb - dnj ( untreated - ut ). fig2 is a bar chart which shows the cholera toxin binding sites per cell for four different cell lines ( hl - 60 , h9 , k - 562 and molt - 4 ) in which the cholera toxin was fluorescein conjugated and the levels of binding to the cell surfaces of untreated ( ut ) cells and cells treated with 0 . 5 mm n - butyl deoxynojirimycin (+ nb - dnj ) were measured by flow cytometry . fig3 shows by thin layer chromatography ( tlc ) the effects on wehi - 3b cells cultured in the presence (+) or absence (-) of an irreversible glucocerebrosidase inhibitor , conduritol β epoxide ( cbe ), to mimic the inherited disorder found in gaucher &# 39 ; s disease in which the cells were cultured in the presence ( 5 to 500 μm ) or absence (-) of n - butyl deoxynojirimycin ( nb - dnj ) and in which the glucosylceramide ( glc - cer ) levels were examined by tlc analysis . fig4 in four parts , a , b , c and d , shows the effects as in fig3 but in which the glucosylceramide ( glc - cer ) levels were measured by transmission electron microscopy instead of tlc . fig4 a shows untreated representative lysosome ; fig4 b shows lysosome treated with cbe ; fig4 c shows lysosome treated with cbe plus 500 μm plus nb - dnj ; fig4 d shows lysosome treated with cbe plus 50 μm nb - dnj . the scale bar of fig4 is shown in fig4 d and represents 0 . 1 μm . fig5 is a graphical representation which shows the inhibition of cholera toxin binding in hl - 60 cells cultured in the presence of various n - alkyl - dnj compounds as indicated at a range of doses ( 0 . 0 to 1 . 0 mg / ml ) or untreated ( ut ) for three days at each dose and assayed by flow cytometry following staining with fitc - cholera toxin . the data are plotted as dose of compound ( mg / ml ) on the x - axis against mean channel fluorescence intensity ( mean channel number ) on the y - axis . fig6 in four parts , a , b , c and d , shows by autoradiographic visualization the effects as in fig1 compared to similar treatment with pdmp or ppmp . fig6 a : untreated ( ut ); fig6 b : in the presence of 0 . 5 mm n - butyl deoxynojirimycin ( nb - dnj ); fig6 c : in the presence of 5 μm pdmp ; fig6 d : in the presence of 5 μm ppmp . in order to further illustrate the invention , the following detailed examples were carried out although it will be understood that the invention is not limited to these specific examples or the details described therein . to investigate the effects of the imino sugar n - butyldeoxynojirimycin ( nb - dnj ) on glycolipid biosynthesis , hl - 60 cells were metabolically labelled with [ 14 c ]- palmitic acid in the presence or absence of 0 . 5 mm nb - dnj . total cellular lipids were solvent extracted and separated by two dimensional thin layer chromatography ( 2d - tlc ) and the individual components visualized by autoradiography ( fig1 ). the major cellular phospholipid species were unaffected by nb - dnj treatment as verified by tlc spot elution , recovery and scintillation counting . however , both the neutral glycolipids and gangliosides were absent from treated cultures ( fig1 b ). this implied that a very early step in glycolipid biosynthesis was affected by nb - dnj treatment . to establish whether this activity was a common property of imino sugars and related compounds , a number of n - linked oligosaccharide processing inhibitors were assayed for their ability to inhibit hl - 60 glycolipid biosynthesis using 2d - tlc analysis ( table 4 ). the glucosidase inhibitors dnj and castanospermine , and the mannosidase inhibitors swainsonine and deoxymannojirimycin ( dmj ), had no effect . when the n - alkylated derivatives of dnj were tested the n - methyl analogue had no effect but both the n - butyl and n - hexyl analogues surprisingly inhibited the biosynthesis of glycolipids . this indicated that the length of the alkyl chain was a critical parameter for this inhibitory activity . in addition , nb - dnj was inhibitory at relatively low compound concentrations ( approximately 50 μm ) indicating that this compound is a more potent inhibitor of glycolipid biosynthesis than it is as an α - glucosidase i inhibitor ( mm range in cell culture systems ). it is believed that the n - butyl and n - hexyl derivatives are specifically inhibiting udp - glucose : n - acylsphingosine glucosyltransferase [ basu et al ., j . biol . chem . 248 , 1388 - 1394 ( 1973 )]( ec 2 . 4 . 1 . 80 ). this transferase is pivotal in generating glucosyl ceramide ( glc - cer ) which is the precursor for the more complex glycosphingolipids and gangliosides . the inhibition of the glucosyltransferase is consistent with the uniform loss of all glycolipid species observed in the presence of the two compounds ( fig1 ). in cell free assays nb - dnj but not dnj inhibited the transfer of glucose from udp - glucose to a ceramide acceptor . this example illustrates that glycolipid expression at the cell surface is also inhibited in cells cultured in the presence of nb - dnj . four cell lines ( of both myeloid and lymphoid origin ) were grown in medium containing 0 . 5 mm nb - dnj for three days and the level of cell surface gm1 ( galβ3galnacβ4 ( neuacα3 )- galβ4glcβ3cer ) glycolipid expression was measured by flow cytometry . as a specific probe , advantage was taken of the gm1 binding specificity of the cholera toxin b chain [ van heyningen , nature 349 , 415 - 417 ( 1974 ); karlsson , ann . rev . biochem . 58 , 309 - 350 ( 1989 )]. the toxin was fluorescein conjugated and the levels of binding to the cell surface of treated and untreated cell lines was measured ( fig2 ). the number of cholera toxin binding sites per cell was determined by including fluoresceinated microbead standards in the assay . the four cell lines showed different levels of cholera toxin binding . the two myeloid cell lines ( hl - 60 and k - 562 ) both expressed approximately 1 × 10 5 copies of cholera toxin binding sites per cell while the two lymphoid cell lines ( molt - 4 and h9 ) expressed approximately 2 . 5 - 5 . 0 × 10 5 copies per cell . the binding of cholera toxin to the four cell lines cultured in the presence of nb - dnj was reduced by approximately 90 % in all cases . this was consistent with the loss of gm1 from the cell surface and provided further evidence for the inhibition of glycolipid biosynthesis by nb - dnj . it also suggests that imino sugar derivatives have use as potential anti - microbial agents by inhibiting the surface expression of glycolipid receptors for bacteria and bacterial toxins as shown in tables 1 and 2 , respectively . the identification of nb - dnj and n - hexyl dnj as novel inhibitors of glycolipid biosynthesis offers an alternative approach for manipulating cellular glycolipid levels . the glycolipid storage disorder , gaucher &# 39 ; s disease , results from the autosomal inheritance of a defective glucocerebrosidase enzyme ( β - d - glucosyl - n - acylsphingosine glucohydrolase , ec 3 . 2 . 1 . 45 ) which prevents the complete catabolism of glc - cer in the lysosome [ barranger and ginns , the metabolic basis of inherited disease , 1677 - 1698 ( mcgraw - hill , new york , 1989 ); tybulewicz et al ., nature 357 , 407 - 410 ( 1992 ); beutler , science 256 , 794 - 799 ( 1992 )]. however , in contrast with the impaired degradation of glc - cer , the rate of glycolipid biosynthesis in these individuals remains normal . as a consequence , glc - cer is accumulated over time leading to lysosomal storage in cells of the monocyte - macrophage system which is diagnostic of this disorder [ parkin and brunning , prog . clin . biol . res . 95 , 151 - 175 ( 1982 )]. one approach for the management of this and related disorders [ neufeld , ann . rev . biochem . 60 , 257 - 280 ( 1991 )] is to use specific inhibitors of glycolipid biosynthesis [ vunnam and radin , chem . phys . lipids 26 , 265 - 278 ( 1980 ); inokuchi and radin , j . lip . res . 28 , 565 - 571 ( 1987 ); abe et al ., j . biochem . 111 , 191 - 196 ( 1992 )] to reduce cellular glycolipid production to a level which can be completely catabolized by the defective glucocerebrosidase , thereby preventing glycolipid accumulation . this example illustrates that glycolipid storage can be prevented by nb - dnj in an in vitro model of gadchef &# 39 ; s disease . the murine macrophage cell line wehi - 3b was cultured in the presence of an irreversible glucocerebrosidase inhibitor , conduritol β epoxide ( cbe ), to mimic the inherited disorder found in gaucher &# 39 ; s disease [ newburg et al ., exp . molec . pathol . 48 , 317 - 323 ( 1988 )]. wehi - 3b cells are described in cancer res . 37 , 546 - 550 ( 1977 ), and are readily available from the american type culture collection , rockville , md ., under accession number atcc tib 68 . the wehi - 3b cells were cultured in the presence or absence of nb - dnj and glucosylceramide levels were examined by tlc analysis ( fig3 ). following cbe treatment the cells accumulated glc - cer relative to untreated controls . however , in cultures containing 500 μm or 50 μm nb - dnj , this accumulation was prevented . at the lower dose ( 50 μm ) cultures contained glc - cer levels comparable to untreated controls whereas at the highest dose ( 500 μm ) cultures contained almost undetectable levels of glc - cer . cells treated with 5 μm nb - dnj were identical to cbe treated cells demonstrating that in this in vitro gaucher &# 39 ; s disease model a compound dose of 50 μm nb - dnj will prevent glc - cer accumulation . the lysosomes of cbe treated cultures and cbe plus nb - dnj cultures were examined by transmission electron microscopy ( fig4 ). there was evidence of lipid accumulation in the lysosomes of cbe treated cells , fig4 b , relative to untreated controls , fig4 a , but not in cbe + nb - dnj treated cultures fig4 c , 500 μm and fig4 d 50 μm , thereby confirming that nb - dnj prevented cbe induced glycolipid accumulation by the partial inhibition of glycolipid biosynthesis . the identification herein of n - alkyl derivatives of dnj capable of modulating cellular glycolipid levels is useful for the management of several glycolipid storage disorders . these compounds affect glc - cer biosynthesis which is the precursor of glycolipids accumulating in many storage disorders , independent of the individual enzyme defects of these diseases ( neufeld supra ). see table 3 , hereinbefore , which lists hereditary glycolipid storage disorders and their corresponding lipid accumulation and enzyme defect . in addition , these compounds have therapeutic use for the treatment of infectious disease agents which utilize cellular glycolipid receptors ( karlsson , supra ) and as modulators of cell proliferation [ hakomori , ann , rev . biochem . 50 , 733 - 764 ( 1981 ); felding - habermann et al ., biochemistry 29 , 6314 - 6322 ( 1990 )], tumor growth [ inokuchi et al ., cancer lett . 38 , 23 - 30 ( 1987 )] and metastasis [ inokuchi et al ., cancer res . 50 , 6731 - 6737 ( 1990 ); mannori et al ., int . j . cancer 45 , 984 - 988 ( 1990 )], where roles for glycolipids have been implicated . the detailed procedures for obtaining the results of examples i to 3 above , as shown by fig1 to 6 and table 4 are as follows : effects of nb - dnj on total hl - 60 lipid composition . lipid identities were determined by comparison to authentic lipid standards , differential chemical detection of phospholipids and glycolipids and laserdesorption mass spectrometry analysis of the mono and dihexaside species . lipids were assigned as follows ( untreated cells , fig1 a - left hand panel ): 1 . gangliosides ; 2 . lysophospatidylcholine ; 3 . ceramide phosphorylcholine ; 4 . ceramide phosphorylethanolamine ; 5 . phospatidylcholine ; 6 . phosphatidylinositol ; 7 . phosphatidylethanolamine ; 8 . phosphatidylglycerol ; 9 . diglycosylceramide ; 10 . monoglycosylceramine ; 11 . cholesterol / fatty acids / neutral lipids ; n and n * are unknowns and 0 is the sample origin . following nb - dnj treatment ( fig1 b - right hand panel ) species 1 ( gangliosides ), 9 ( diglycosylceramide ), 10 ( monoglycosylceramide ) and n , ( unknown ) were absent . method : hl - 60 cells were cultured ( 10 ml ) by conventional procedures as previously described [ platt et al ., eur . j . biochem . 208 , 187 - 193 ( 1992 )] at a seeding density of 5 × 10 4 cells per ml in the presence or absence of 0 . 5 mm nb - dnj ( g . d . searle & amp ; co ., skokie , ill .) for 24 hours . for labelling and 2d - tlc , the conventional , published method of butters and hughes was followed [ in vitro 17 , 831 - 838 ( 1981 )]. briefly , [ 14 c ]- palmitic acid ( icn - flow , high wycombe , bucks . uk ., 56 . 8 mci / mmol ) was added as a sonicated preparation in fetal calf serum ( 0 . 5 μci per ml ) and the cells were cultured for a further three days maintaining nb - dnj in the cultures . the cells were harvested , washed three times with pbs and extracted in i ml chloroform : methanol ( 2 : 1 v / v ) overnight at 4 ° c . the extracts were centrifuged , the chloroform : methanol extract was retained and the pellet was re - extracted as above for two hours at room temperature . pooled extracts were dried under nitrogen and redissolved in 50 μl chloroform : methanol ( 2 : 1 , v / v ). one percent of the sample volume was taken for the determination of radioactivity by scintillation counting and a 1 × 10 6 cpm loaded as a single spot onto a 20 cm 2 tlc plate ( merck , bdh , poole , dorset , u . k .). the samples were separated in the first dimension in chloroform : methanol : water ( 65 : 25 : 4 ) and the plate dried overnight under vacuum . separation in the second dimension was achieved using a solvent of tetrahydrofuran : dimethoxymethane : methanol : water ( 10 : 6 : 4 : 1 ). plates were air dried and exposed to hyperfilm - mp high performance autoradiography film ( amersham international , amersham , uk ). effects of sugar analogues on hl - 60 glycolipid biosynthesis . the data are summarized from 2d - tlc analysis on each compound at the indicated concentrations ( see fig1 method , above ). compounds : the synthesis of alkylated derivatives of dnj is well known . see , e . g ., fleet et al ., febs lett . 237 , 128 - 132 ( 1988 ). dmj was purchased from boehringer mannheim ( lewes , sussex , u . k . ), swainsonine and castanospermine were obtained from sigma ( poole , dorset , uk ). compound doses were selected that were close to the tolerated upper limit of the individual compounds which maintained ninety percent cell viability . hl - 60 cells were cultured as described in fig1 procedure , above . table 4______________________________________compound dose ( mg / ml ) glycolipid inhibition______________________________________dnj 0 . 2 - n - methyl dnj 0 . 1 - n - butyl dnj 0 . 001 +/- n - butyl dnj 0 . 01 + n - butyl dnj 0 . 1 + n - hexyl dnj 0 . 2 + dmj 0 . 06 - castanospermine 0 . 1 - swainsonine 0 . 1 - ______________________________________ quantitative analysis of cholera toxin binding to human cell lines following three days treatment with nb - dnj . methods : cells were maintained in logarithmic phase growth in rpmi - 1640 medium . cholera toxin b chain ( sigma ) was conjugated to fluorescein isothyocyanate ( sigma ) and flow cytometric analysis was carried out by conventional procedure as described by platt et al ., supra . analysis was performed on a facscan cytometer ( becton dickinson , sunnyvale calif ., usa ). data on viable cells were collected on a four decade log 10 scale of increasing fluorescence intensity . the data are presented as mean copy number of cholera toxin bindings sites per cell on the y - axis against the four cell line on the x - axis , in the presence or absence of 0 . 5 mm nb - dnj . the specificity of cholera toxin : cell surface binding was established by inhibiting this interaction with a one hundred fold molar excess of gm1 derived oligosaccharide , galβgalnacβ4 ( neuacα3 ) galβ4glcβ3cer . seventy to ninety percent inhibition was achieved depending on the individual cell line . a control oligosaccharide ( lacto - n - tetarose ) was not inhibitory . effects of nb - dnj on an in vitro model of gaucher &# 39 ; s disease . fig3 : 1 dimensional tlc analysis on wehi - 3b cells treated as indicated . fig4 : transmission electron microscopy of wehi - 3b gadchef cell lysosomes : a . untreated representative lysosome , b . lysosome showing extensive accumulation of dense material in the presence of cbe consistent with glc - cer accumulation , c . cbe plus 500 μm nb - dnj and d . cbe plus 50 μm nb - dnj , each of c and d showing lysosomes with normal density contents . no changes were observed in the lysosomes of cells treated with nb - dnj alone . methods : the murine macrophage cell line wehi - 3b was maintained in logarithmic phase growth for 14 days in rpmi - 1640 in the presence or absence of 50 μm conduritol β epoxide ( cbe , toronto research chemicals , downsview , canada ) with or without nb - dnj at the indicated concentrations . cells were passaged every three days in the presence of the stated concentrations of compounds . equal cell numbers ( 5 × 10 6 ) were harvested , extracted as described hereinbefore ( fig1 procedure ), separated by one dimensional tlc ( first dimension solvent , fig1 procedure ) and visualized using α - naphthol ( 1 % w / v in methanol ) followed by 50 % ( v / v ) sulphuric acid . similar data were obtained using the independent mouse macrophage cell line p388d - 1 . these cells are described in j . immunol . 114 , 894 - 897 ( 1975 ), and are readily available from the american type culture collection , rockville , md ., under accession number atcc tib 63 . the authentic glc - cer standard from human gaucher spleen ( arrows ) was purchased from sigma . cells for electron microscopy were harvested ( 1 × 10 7 cells per treatment ), washed three times in serum free rpmi - 1640 medium and fixed in medium containing 2 % glutaraldehyde ( v / v ) on ice for two hours . cells were washed in 0 . 1 m cacodylate buffer containing 20 mm calcium chloride ( w / v ). fixed cells were stained with 1 % osmium tetroxide in 25 mm cacodylate buffer ( w / v ) containing 1 . 5 % potassium ferrocyanide ( w / v ) for 2 hours on ice . samples were dehydrated through an ethanol series ( 50 , 70 , 95 and 100 % v / v ), transferred to propylene oxide and embedded in embed 800 ( electron microscopy sciences , pa ., usa ). the samples were polymerized at 60 ° c ., sections cut , stained with uranyl acetate / lead citrate and observed with a hitachi 600 microscope at 75v . dose response curves of cholera toxin binding to hl - 60 cells following three days treatment with various n - alkyl - dnj compounds . the test method employed for fig5 was the same as for fig2 above , but the data are plotted as dose of compound on the x - axis against mean channel fluorescence intensity on the y - axis . the n - methyl , n - ethyl , n - propyl , n - butyl and n - hexyl derivatives of dnj were thus tested and compared with the untreated ( ut ) control sample . effects of nb - dnj , pdmp and ppmp on total hl - 60 lipid composition . the test method employed for fig6 was the same as for fig1 above , but was extended to include for comparison treatment with dl - threo - 1 - phenyl - 2 - decanoylamino - 3 - morpholino - l - propanol ( pdmp ) or dl - threo - 1 - phenyl - 2 - hexadecanoylamino - 3 - morpholino - 1 - propanol ( ppmp ), both obtained from matreya inc ., pleasant gap , pa . fig6 a : untreated cells as in fig1 a - left panel ; fig6 b : cells treated with 0 . 5 mm nb - dnj as in fig1 b - right panel ; fig6 c : cells treated with 5 μm pdmp from 10 mm stock solution in ethanol ; fig6 d : cells treated with 5 μm ppmp from 10 mm stock solution in ethanol . in addition to their use as antimicrobial agents and as inhibitors of glycolipid biosynthesis in cells , the inhibitory agents described herein also can be used for administration to patients afflicted with glycolipid storage defects by conventional means , preferably in formulations with pharmaceutically acceptable diluents and carriers . these agents can be used in the free amine form or in their salt form . pharmaceutically acceptable salt derivatives are illustrated , for example , by the hcl salt . the amount of the active agent to be administered must be an effective amount , that is , an amount which is medically beneficial but does not present toxic effects which overweigh the advantages which accompany its use . it would be expected that the adult human daily dosage would normally range from about one to about 100 milligrams of the active compound . the preferable route of administration is orally in the form of capsules , tablets , syrups , elixirs and the like , although parenteral administration also can be used . suitable formulations of the active compound in pharmaceutically acceptable diluents and carriers in therapeutic dosage form can be prepared by reference to general texts in the field such as , for example , remington &# 39 ; s pharmaceutical sciences , ed . arthur osol , 16th ed ., 1980 , mack publishing co ., easton , pa . various other examples will be apparent to the person skilled in the art after reading the present disclosure without departing from the spirit and scope of the invention . it is intended that all such other examples be included within the scope of the appended claims .

US-6164593-A

an improved gravity feed product dispenser track apparatus for products sold in containers having a truncated conical shape , such as a bell shape or an inverted bell shape used for certain popular yogurt products . the dispenser track assembly of the present disclosure aligns the products on a track with a front discharge portion and an exit ramp that tilts the lead product forward or rearward so that the inclined or declined front surface of the container is pivoted to a more vertical state to improve its visibility for customers . a plurality of pull through fingers is disposed near front discharge portion . these fingers maintain a lead container on the track while also allowing a customer to remove a container by pulling it through the opening between the fingers .

two embodiments of the dispenser track assembly are illustrated herein , the first shown in fig1 - 11 and second shown in fig1 - 17 . fig1 - 24 illustrate other features of the dispenser track assembly . for convenience and clarity , the same or similar elements in the embodiments will be given the same reference numbers . in the drawings and in the descriptions which follow , the term “ proximal ,” as is traditional , will refer to the end of the dispenser track assembly which is closer to the user , while the term “ distal ” will refer to the end which is farther from the user . the first embodiment has been designed to accommodate a product of a particular shape as described below ; however , the principles of this product dispenser are applicable for dispensing articles of many other shapes . the products shown in the drawings of the first embodiment are inverted bell - shaped containers corresponding to the containers of a very popular yogurt . when sold in supermarkets and other stores , these containers are commonly stocked in rows extending front - to - rear with only the lead container being clearly visible to customers . typically , there are additional rows above and below and left and right on multi - level shelves . fig1 and 2 show perspective and side elevation views respectively of the first embodiment of the dispenser track assembly generally referred to by reference number 1 . this assembly as shown has upper , middle and lower tracks 2 , 3 and 4 , respectively , with side edges of the tracks 2 , 3 and 4 secured to side walls 5 and 6 . the number and dimensions of the tracks will vary depending on the size and shape of the articles being dispensed . each side wall 5 and 6 is a contiguous panel for supporting all the tracks attached thereto . the dispenser track assembly 1 also includes a front discharge portion 2 a ( for track 2 ), an exit ramp 9 and a rear end 2 b . the dispenser track assembly 1 can be supported and secured on a shelf or can be supported as shown with a cantilever bracket 7 removably attached to a wall or other support 7 a . in a particularly useful embodiment , the dispenser track assembly 1 , when mounted , will be oriented with the front discharge portion 2 a inclined downwardly at an angle in the range of about 5 degrees to about 15 degrees to produce a gravity feed for the articles on the tracks 2 , 3 and 4 . an alternative arrangement for use with horizontally oriented tracks without gravity feed , uses a mechanical or electrical pusher for urging the articles toward front discharge portions of the tracks ( not shown ). for the gravity feed arrangement shown in fig1 and 2 , the principal description herein will be of the upper track 2 and articles thereon , the other tracks 3 and 4 being substantially the same . as noted above , the articles illustrated on track 2 of fig1 and 2 represent containers of a popular brand of yogurt frequently sold in product dispensers of this type . each of these containers 11 a - 11 f has an inverted bell shape that is generally flat on the top and the bottom and has a larger diameter top with a downward inclined front surface . as discussed later herein , the dispenser track assembly 1 has significant improvements over conventional dispenser tracks for articles of this inverted bell shape . as seen in fig1 - 3 , due to the downward incline , containers 11 a - 11 h ( containers generally referred to as numeral 11 ) aligned on track 2 tend to slide downward toward front discharge portion 2 a of track 2 , with lid 8 of each container 11 contacting lid 8 of the next adjacent container 11 . lead container 11 a at the front discharge portion 2 a of track 2 is situated on an upwardly inclined exit ramp 9 . in fig3 and 10 the middle track 3 is more fully depicted than upper track 2 , and therefore reference will be made to “ middle ” track 3 when describing a typical track for which earlier reference has been to “ upper ” track 2 . as seen in fig1 - 3 , for these inverted bell - shaped containers 11 a - 11 h , front wall surface of each container 11 , except for lead container 11 a on exit ramp 9 , is inclined downwardly , which renders the label thereon difficult for a customer to easily notice and read . the exit ramp 9 at the front discharge portion 2 a of track 2 overcomes the label visibility problem because lead container 11 a on exit ramp 9 becomes tilted so that its front surface is tilted upwardly and rearwardly into a generally vertical state . this tilting by the exit ramp 9 compensates for the natural downward incline of the inverted - bell shape and the forward incline of the track 2 , thus rendering the label more easily readable by a customer . quick recognition of the product by customers in supermarkets is important whether the seller hopes to capitalize on impulse purchases or to merely assist the customer in finding what he or she seeks . additionally , this tilting via exit ramp 9 enables a customer to easily read nutritional information , usually located opposite the label , by turning container 11 . the front discharge portion 2 a of track 2 includes a fence 15 ( also called front stop hoops ) formed of a pair of curved fingers 16 , each attached to one of side walls 5 , 6 and extending forward in a curved manner . as seen in fig7 , between tips 17 of fingers 16 is gap 18 providing more visibility for the label and providing access for a customer to more easily grasp and remove lead container 11 a . these fingers 16 restrain lead container 11 a from falling off the exit ramp 9 , but allow the lead container 11 a to be tilted forward and lifted off track 2 by a customer ( fig1 ). following removal of lead container 11 a , the next adjacent container 11 b will slide forward into the position previously occupied by lead container 11 a . as seen in fig2 and 16 the fence 15 is removably coupled to the track by tabs 12 and 13 which engage corresponding slots in side walls 5 and 6 and do not protrude through these slots beyond outer surface of walls 5 and 6 . as seen in fig2 and 10 , the front discharge portion 2 a of the exit ramp 9 of the upper track 2 is displaced slightly rearward of the front edge 3 a of the middle track 3 . this provides sufficient clearance space 14 above lead container 19 on middle track 3 for container 19 to be lifted upward over its fence 15 without being blocked by the front edge 2 a of top track 2 . the front edge 3 a of the middle track 3 is similarly displaced slightly rearward of the front edge 4 a of lower track 4 , the result being a cascade appearance of the three front edges 2 a , 3 a and 4 a of the three tracks 2 , 3 and 4 respectively . since the three tracks are substantially the same length to contain a uniform number of containers , their rear ends 2 b , 3 b and 4 b will have an inverted cascade appearance adjacent the vertical wall support 7 a . an automatic container barrier is illustrated in fig2 , 4 - 6 and 6 a at the rear end of each track . this feature comprises back strap 20 formed in a u - shape with arms 21 pivotally connected to side walls 5 and 6 . between arms 21 is a cross bar or retainer bar 22 which is a generally flat strap lying closely adjacent and generally parallel to top surface of track 2 in fig4 and elevated above track 2 in fig5 and 6 a . it is also envisioned for the back strap 20 to be in an l - shape and having only a single arm . the first stage of operation for the automatic container barrier is seen in fig4 where a container 11 h moving rearward is about to engage the retainer bar 22 of back strap 20 . further rearward movement of container 11 h is seen in fig5 , where the rear wall surface of container 11 h has engaged and is pushing the retainer bar 22 , which has begun to swing rearward and upward . finally , as seen in fig6 and 6 a , container 11 h has pushed or been pushed further rearward , retainer bar 22 has swung as far as it can go in the available arc of the arms 21 , and blocks farther rearward movement of container 11 h . since the back strap 20 is freely pivotable , it will swing forward and return to its original position when any or all containers have moved forward and out of contact with retainer bar 22 . in its original forward and down position seen in fig4 , the back strap 20 will always be ready to engage and restrain a container 11 h being pushed rearwardly . it should be noted that back strap 20 , in its initial down position in fig4 , has retainer bar 22 generally flat and close to the track &# 39 ; s top surface , and arms 21 are spaced - apart and close to side walls 5 , 6 . consequently , containers can be loaded from the rear , where each container is pushed between the arms 21 , over the retainer bar 22 and onto the track &# 39 ; s top surface . this allows optional loading of containers from the front or the rear of the track . in the embodiment shown in fig1 and 2 , each track 2 , 3 and 4 has laterally extending tabs 30 which are inserted into mating slots 31 in the side walls 5 and 6 , where the tabs may be permanently or releasably coupled to slots 31 . these tabs 30 do not extend beyond the outer surface of side walls 5 , 6 . such a configuration allows multiple dispenser track assemblies to be slid into place in a side - by - side relationship or freely removed without disturbing other multi - tiered dispenser track assemblies . thus , the side walls are coupled to the opposite side edges of each track , and each combination of track plus walls produces an elongated channel in which articles can slide . as seen in fig1 and 2 , at the front discharge portion of the lower track 4 is a bracket or ticket channel 33 with an internal slot 34 to removably receive a product identification and / or a price label . this bracket 33 is removably mounted in a set of tracks 35 ( fig1 ) in front barrier 15 . this bracket 33 also functions as a handle which facilitates pulling the entire assembly in a frontward manner off the supporting shelf to be rear loaded and / or repositioned on the shelf . as further seen in fig1 and 2 , side walls 5 , 6 have a plurality of window - like openings 37 which allow finger access by a clerk to reach into the pathway above a track to align and / or release a container jammed on track 2 , 3 , 4 . these openings 37 also lighten the weight of and reduce the amount of plastic required for side walls 5 , 6 . the multi - tiered dispenser track assembly 1 is shown in solid line in fig1 , with an identical track assembly shown in phantom line immediately adjacent to the right of the solid line dispenser track assembly 1 . this demonstrates that one dispenser track assembly can be positioned directly adjacent and against another identical dispenser track assembly and can be easily removed without interference between their outer side surfaces . smooth and unobstructed outside surfaces are achieved because of the previously described tab - in - slot construction shown ( a ) in fig8 for coupling of the tracks 2 , 3 , and 4 to the side walls 5 , 6 ; ( b ) in fig9 for coupling of the back strap 20 to side walls 5 , 6 ; and ( c ) in fig1 for coupling fence 15 to side walls 5 , 6 . in each case a tab enters but does not protrude through the outside surface of any sidewall . the number of side - by - side multi - tier dispenser track assemblies that are used together is variable , and the number of tiers in each multi - tier track assembly is further variable , within space , weight , economical and aesthetic constraints . fig1 - 17 illustrate a second embodiment 40 of the dispenser track assembly of this disclosure which is similar in part to the first embodiment . as stated earlier , for convenience and clarity , certain elements that are the same in both embodiments will be given the same reference numbers . as shown , dispenser track assembly 40 has upper , middle and lower tracks 42 , 43 and 44 respectively coupled to side walls 5 and 6 via tabs 30 of the tracks extending into slots 31 of the side walls . as seen in fig1 , at the front discharge portions of tracks 42 , 43 , 44 are exit ramps 45 , 46 , 47 respectively . the dispenser track assembly 40 is removably mounted via bracket 7 to rear wall support element 7 a . further , as seen in fig1 - 17 , the products being dispensed are containers 41 a - 41 j corresponding to containers used for a very popular yogurt product , which are recognized by their bell shape , having a larger bottom surface than top surface . fig1 and 13 show containers 41 a - 41 j in a line extending from front to rear on track 42 with container 41 a being the lead container situated on exit ramp 45 . fig1 is a fragmentary top plan view of the front discharge portion of track 43 and its exit ramp 46 , including central longitudinal axis x - x of track 43 . the front discharge portion 46 a of exit ramp 46 has a central area “ a ” defining a crescent recess or notch 50 extending rearwardly between points 50 a and 50 b . this notch 50 provides easier access for a customer &# 39 ; s fingers to grasp the container 51 and better visibility of any label on the front surface of the lead container 51 a . the front edge 46 a of exit ramp 46 has opposite side areas , extending from points 50 a and 50 b rearwardly to points 50 c and 50 d on the side edges of track 43 . circle 53 represents the top edge of container 51 . concentric circles 54 and 54 a represent the bottom lip and outer diameter of this lip of container 51 . the intersection at point 0 , 0 indicates the center of container 41 a . a line y - y through this center and perpendicular to the central longitudinal axis x - x indicates the location of the center of gravity of container 51 . a line y ′- y ′, parallel to line y - y connects points 50 c and 50 d , which becomes the line over which container 51 tips forward due to the forces from all the containers behind the lead container 51 a trying to slide forward , and because the lead container 51 a is poised to tip about a line y - y near its own center of gravity . as seen in fig1 and 16 , the exit ramp 9 will tilt the lead container 51 a forward slightly until stopped by fingers 16 ( also called hoop 16 ) of fence 15 . in this orientation the front surface of the lead container 51 a and label thereon will be clearly visible , and the lead container 51 a is easily removable by a customer who can grasp and lift the lead container 51 a over fence 15 , as further seen in fig1 . fig1 and 18 illustrate high and low versions 15 , 15 a respectively of the fence . the same reference numbers are used for the fingers 16 , bracket 35 and mounting tabs 12 and 13 . the differently shaped fingers on the two fences 15 , 15 a provide different areas of support for the lead container on the exit ramp . fig1 illustrates the same back strap 20 seen in fig4 - 6 , but here employed with the dispenser track assembly of fig1 and containers of the type that are bell - shaped . a further feature of the first embodiment , seen in fig3 , is a wave configuration 55 near the front discharge portion 2 a , 3 a of each of tracks 2 , 3 . these tracks have widths slightly greater than the diameter of the container 11 being dispensed . wave configuration 55 extends for a distance equal to about three container diameters . more specifically , the top surface of track 2 is flat from its rear end forward until wave configuration 55 begins with a downward dip 56 , which is followed by a rise or hill 57 , which is followed by a dip 58 , which is followed by the exit ramp 9 . dip , rise and dip each extend lengthwise a distance about equal to one diameter of container 11 . each of the containers 11 sliding on wave configuration 55 will alternately tilt forward when descending dips 56 , 58 , tilt backward when ascending rise 57 , and tilt further backward ( for an inverted bell - shaped container ) upon ascending exit ramp 9 . the wave configuration 55 can also be used on a track with bell - shaped containers 41 . in this embodiment , exit ramp 9 will tilt the container 41 forward . the purpose of the wave configuration 55 is to induce the container 11 nearing exit ramp 9 to tilt in a manner that will reduce the possibility of the edges of lids of adjacent containers from becoming partially jammed together . such engagement of lid edges could create difficulty for a customer to remove the lead container or could cause a “ traffic jam ” of containers . such jamming is not uncommon , as these containers slide downward on this gravity feed track and their cumulative weight bears on the forwardmost containers . the above - described tracks and side walls are made of opaque molded polyethylene , and the front barrier fence or hoop is made of clear polycarbonate to avoid any obstacles to visibility of the front surface and label on the lead container . many other common industrial plastics may be used . fig1 - 24 illustrate features of another embodiment of the dispenser track assembly 1 . as shown therein , pull through fingers 100 are provided to facilitate dispensing containers 11 . fingers 100 are dimensioned and configured to flexibly hold first container 11 a in place and to flex open to dispense the container 11 a without the need to lift the container 11 a relative to track 110 . in addition , a metering mechanism 120 is shown in fig2 and 22 which precludes the dispensing of more than one container 11 at a time . the metering mechanism 120 in this embodiment is a set of flippers or pivoting fingers which allows only one container 11 at a time to reach the pull through front fingers 100 . this configuration allows for a constant extraction force and further permits long rows of articles to be gravity fed , one at a time , into the shopping area . as shown in fig2 and 24 , a novel one - way rear gate 130 is incorporated to prevent rear - most articles from falling out of the back of the dispenser track assembly 1 as the dispenser track assembly 1 is picked up or moved . in this embodiment , one - way rear gate 130 is a living hinge mechanism which , when engaged by an article 11 sliding rearwardly , will fold rearwardly over onto the wall and prevent the article 11 from falling off of the rear end of the track . the present disclosure may be embodied in other specific forms without departing from the spirit or essential characteristics thereof . the present embodiments are therefore to be considered in all respects as illustrative and not restrictive , the scope of the disclosure being indicated by the appended claims rather than by the foregoing description , and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein . for example , in the embodiment having multiple tracks , it is envisioned for the exit ramps to tilt the articles at differing angles from one another . each of the exit ramps can be angled to position its lead article such that the front surface of the lead article is angled toward a customer &# 39 ; s eye level , thus enabling a customer ( of average height ) to view the front surface of the lead articles on all of the tracks . further , it is envisioned for the angles of tilt on each exit ramp to be adjustable . it is also envisioned that fence is defined by a single finger extending from either side wall of track .

US-9812305-A

a hair accessory made to increase the body and fullness of a ponytail or pig tails . the hair accessory includes a hinged pair of first and second portions movable between an open position and a closed position , each portion having a hinged end and an opposite end , inward facing teeth , and at least one fastener for releasably fastening the portions in the closed position .

as used throughout this specification and claims , ponytail is defined as a hairstyle in which multiple strands of hair on the head is pulled away from the face , gathered and secured at the back of the head with a hair tie , clip or similar device . if the hair is divided so that it hangs in two or more sections , those are pigtails . when used in this specification , ponytail also refers to pigtails . as used throughout the specification and claims , a bun is a type of hairstyle where the hair is pulled back from the face in a ponytail and wrapped in a circular coil around itself , typically on the back of the head or neck . buns may be tightly gathered or slightly messier and more informal . as used throughout the specification and claims , “ a ” means one or more . in one embodiment of the present invention , as illustrated in fig1 a , hair accessory apparatus 10 comprises first portion 12 and second portion 16 both with outside grooves 14 and outside center channel 20 . hair accessory apparatus 10 further comprises hinge 24 , fastener 26 and inward facing teeth 28 . a user preferably separates first curved portion 12 from second curved portion 16 at hinge 24 to receive a portion of hair through portions 12 and 16 . after a portion of hair is threaded through portions 12 and 16 , a user closes hinge 24 bringing portions 12 and 16 together fastening them using fastener 26 . inward facing teeth 28 hold the threaded hair in place . the selected remaining hair is gathered around the outside of hair accessory apparatus 10 . hair tie band 30 is wrapped around the gathered hair and rests into center channel 20 . gathered hair then falls around hair accessory apparatus 10 and into outside grooves 14 increasing the volume and fullness of the hair . fig1 c illustrates a side profile of an embodiment of the present invention , where first portion 12 and second portion 16 are equal thicknesses . outside grooves 14 can optionally vary in width and depth depending on the thickness and amount of a user &# 39 ; s hair and ponytail . fig1 b illustrates an embodiment comprising varying depths of outside grooves 14 . in this embodiment , a user with very thick strands of hair would get the most fullness with wider and deeper outside grooves 14 for the hair to fall into , while a user with very thin strands of hair or with not a lot of hair would get the most fullness and also hide the invention in the user &# 39 ; s hair with narrower and shallower grooves . in a non - limiting embodiment , outside grooves 14 are preferably deeper on one side of center channel 20 allowing the gathered hair to go up and over deeper outside grooves 14 adding additional height to the ponytail . outside grooves 14 can also optionally go partially around first and / or second portions 12 and 16 as illustrated in fig5 b or not be included at all , as illustrated in fig2 and 5c . the distance between inward facing teeth 28 and outside grooves 14 can preferably vary since outside grooves 14 can be shallow and / or deep . hair tie band 30 can include , but is not limited to , elastic hair ties , ribbons , leather bands , decorative hair ties and any combination thereof . decorative hair ties can comprise decorative accessories that can include but are not limited to beads , charms , shells , silver and / or gold dangles , pearls , gems , jewels , ribbons , glitter , sparkles and any combination thereof . hair accessory apparatus 10 can optionally vary in width . for example , the width of the outside circumference can be greater than or less than the width of the inside circumference of hair accessory apparatus 10 . in other words , hair accessory apparatus 10 can be thick around the outside circumference and become thinner towards the center . in one embodiment of the present invention , inward facing teeth 28 vary in length to either enlarge or reduce the open space in the center of apparatus 10 . for thinner hair strands or when there is not a lot of hair to fasten , longer inward facing teeth 28 is preferable . for thick hair strands or a large volume of hair , shorter inward facing teeth 28 is preferable . inward facing teeth 28 can optionally reside on only one portion 12 or 16 , as illustrated in fig5 b , or there can be no inward facing teeth 28 , as illustrated in fig5 c . moreover , inward facing teeth 28 can have different shapes , including but not limited to , being pointed at the end , rounded at the end or squared off at the end ; inward facing teeth 28 can also optionally intermesh or not . in another embodiment of the present invention , illustrated in fig2 , first curved 12 and second portion 16 are separate pieces , not having hinge 24 . in this embodiment , first portion 12 and second portion 16 fasten around a portion of hair with fasteners 26 and 34 . fasteners 26 and 34 can include , but are not limited to , clips , snaps , buttons , and any combination thereof . in a further embodiment , as illustrated in fig5 a and 5d , hair accessory 10 can be made as one piece not including fasteners 26 and 34 or hinge 24 . in yet another embodiment of the present invention illustrated in fig3 a and 3b , the bottom portion of second portion 16 is wider than the bottom portion of first portion 12 . first portion 12 is placed against a user &# 39 ; s head while the wider portion of second portion 16 is directed to the bottom of a user &# 39 ; s head where the wider portion is located between the selected portion of hair and elastic band 30 . this allows the hair to fall at a greater distance from the head further increasing the look of fullness of the ponytail . in a further embodiment as shown in fig4 a and 4b , apparatus 10 further comprises hood 32 that attaches to first portion 12 to allow the hair to go up and over hood 32 . hood 32 increases the height of the ponytail and further increases the look of fullness . fig4 b in a side perspective of apparatus 10 comprising hood 32 . fig5 a - 5d illustrate additional embodiments of the present invention . in fig5 a - 5d , apparatus 10 can preferably vary in size and shape including but not limited to circular , oval , elliptical , egg - shaped , star shaped or any combination thereof . further , fig5 a and 5d illustrate an embodiment of the present invention wherein apparatus 10 is a one - piece apparatus with no portions 12 or 16 , and no fasteners 26 or 34 or hinge 24 . fig5 b illustrates apparatus 10 with inward facing teeth 28 on one only portion 12 or 16 and outside grooves 14 on only one portion 12 or 16 . fig5 b also comprises hinge 24 and fastener 26 . fig5 c illustrates apparatus 10 with no outside grooves 14 and no inward facing teeth 28 , but does comprise hinge 24 and fastener 26 . in another embodiment , the width of first portion 12 and second curved portion 16 can vary according to the thickness of the user &# 39 ; s hair . for example , users with very thick hair may need both first portion 12 and second portion 16 to be wide while users with very thin hair prefer first portion 12 to be narrow in order to ensure apparatus 10 does not poke through the hair and thus become visible , and second portion 16 to be wider in order to increase the fullness of the ponytail . in yet another embodiment and as illustrated in fig6 a and 6b , apparatus 10 additionally comprises button 50 . button 50 is preferably used to secure a user &# 39 ; s hair inside apparatus 10 forming a loose bun . in this embodiment , apparatus 10 secures a user &# 39 ; s hair into a ponytail , as described in previous embodiments . then the ends of the hair are gathered and placed inside apparatus 10 , and button 50 is then used to secure the hair between the inner circumference of apparatus 10 and the outside of button 50 . although the invention has been described in detail with particular reference to these preferred embodiments , other embodiments can achieve the same results . variations and modifications of the present invention will be obvious to those skilled in the art and it is intended to cover in the appended claims all such modifications and equivalents . the entire disclosures of all references , applications , patents , and publications cited above are hereby incorporated by reference .

US-12038708-A

a method and apparatus for characterizing gastrointestinal sounds includes a microphone array to be positioned on a body for producing gastrointestinal sound signals . the signals are digitized and their spectra and duration is determined by a processor . a characterization as to the state of the gastrointestinal tract is made on the basis of the spectra and duration of the sound or event .

referring now to the drawings and especially to fig1 an apparatus for characterizing gastrointestinal sound is generally shown therein and identified by numeral 10 . the apparatus 10 includes a microphone array 12 having a free microphone 14 , an array microphone 16 , a second array microphone 18 and a third array microphone 20 coupled to filter and amplifier 22 which feeds multiple analog signals representative of the gastrointestinal sounds over leads 24 to a tascam 2000 multichannel tape recorder 26 where the analog signals may be recorded in analog format . the sound signals may then be transferred over lead 28 to a computer 30 for analysis . following analysis output results may be displayed on a video display terminal 32 or output through a printer 34 . referring now to fig2 a block diagram of the computer 30 is shown therein . the computer 30 receives the analog gastrointestinal sound signals on a line 23 at an analog to digital converter . the gastrointestinal signals are digitized and fed over lines 40 to a system bus 42 of the computer 30 . the computer 30 includes a disk controller 44 having connected to it a hard disk drive 46 and a floppy disk drive 48 . the hard disk drive 46 stores a program as represented by the flow charts of fig7 through 37 inclusive . upon receipt of sound signals from a patient the software routines are transferred from the hard disk drive 46 through the disk controller 44 to the system bus 42 and are loaded into random access memory 50 connected to the system bus for execution by a microprocessor 52 . portions of the code and data of the software may be stored from time to time in a cache memory associated with the microprocessor 52 . read only memory 54 contains operating system information and outputs may be provided from the system bus by a video controller 56 to a video output line 31 connected to the display 32 . likewise , outputs may be connected through an input / output module , having parallel and serial ports 58 , through a line 33 . the microphone array 12 , as may best be seen in fig3 and 4 , microphones 14 through 20 placed on a torso 70 of a human being with the free microphone 14 being placed near the sternum and the array microphones 15 through 20 attached slidingly to array arms 72 , 74 and 76 . the sliding adjustable microphone harness is necessary to accommodate subjects of a wide variety of sizes . the microphones respectively are located to pick up multiple gastrointestinal sound sources from the human torso to provide analog signals to the computer 30 . the computer 30 , by execution of the routines shown in fig7 through 43 , inclusive , determines the spectra and the duration of the individual gastrointestinal events and provides an output indication thereof in response to the signal and the variables input as set forth in the tables below . the use of the multiple microphone array in combination with the routines set forth in the flow charts which are executed by computer allows quick and easy analysis of the gastrointestinal sounds for the determination of conditions such as small bowel obstruction , ileus and the like . referring now to the drawings and especially to fig7 an overall flow diagram for gastrointestinal sound capture is shown herein wherein in a first step a patient 200 is fitted with the microphone array in a step 202 following which sounds captured by the microphone array 202 are fed to an analog amplifier and filter . prior to analyzing captured sound the variable set found in table 2 are in initialized to proper values . table 2 provides optimized values of these settings for the current hardware and system . in addition , the sounds may be fed into the multichannel tape recorder in a step 206 which may then also feed the sounds to the analog amplifier filter 204 . the amplifier filters and then feeds sounds to an analog to digital converter in the step 208 which converts the sounds to digitized sound signals for analysis by the computer in a step 210 . as shown in fig8 the computer is able to find acoustic events in a step 212 and to characterize the acoustic events in the step 214 . it recognizes gastrointestinal acoust 13 c phenomena ( gap ) events in a step 216 . in addition , from other portions of the routine other patient acoustic characteristics such as trans - abdominal spectra and velocity modulation are determined in a step 220 . clinical information may also be input through a keyboard or other appropriate means in a step 222 , all of which are fed to a pattern recognition algorithm in a step 224 for providing diagnoses with probabilities in a step 226 . in addition , the information received by the pattern recognition algorithm may be output in a step 228 and subject to physician interpretation in a step 230 . in an alternative version as shown in fig9 the patient may be attached to a microphone array in a step 240 . the microphone array captures sounds in a step 242 and provides electrical signals to a single or multichannel analog tape recorder in a step 244 and also to an analog amplifier and filter in a step 246 . the sounds are converted from analog form to digital form in a step 248 and the digitized sound signals may be provided to a modem in a step 250 for transmission to a centralized computer facility . in an ambulatory monitoring system the patient may be connected to the microphone array in a step 262 as shown in fig1 . the microphone captures sounds in a step 264 and the sound signals are recorded by a single channel analog tape recorder in a step 266 for provision to other systems . the patient or the system may supply timing markers indicative of symptoms , events or time duration in a step 268 . the same monitoring schema may also be used for long term monitoring over extended periods of time at low tape speed . in that case the electronic marker signal would comprise a timing signal impressed upon one of the channels . the timing signal would be used by digital processing to remove or reduce timing perturbations introduced by low speed flutter and wow in the tape recorder . in a still further alternative , as shown in fig1 , the patient may be connected to a microphone belt or pad in a step 270 . the microphone belt or pad may convert the sound signals to analog signals in a step 272 and the analog sound signals are recorded in a step 274 for later provision to a computer the patient or the system may supply timing markers indicative of symptoms , events or time duration in a step 276 . in general , as shown in fig1 , in order to find acoustic events and features in a step 300 the amplitude envelope is calculated for each of the sound channels . an amplitude threshold is then determined in a step 302 for each channel . in a step 304 the events in each channel are determined using the channel amplitude threshold by using the thresholding as a filtering or screening tool . in a step 306 neighboring signals are designated on the same channel signals as a single event . in a step 308 correlated and nearby events are determined in other channels . in a step 310 a determination is made whether the nearest event is part of an actually related event or is merely coincidental . in a step 312 related events are labeled in other channels to avoid double event counting and the nearest events that are part of related events are also labeled following which the return is exited in a step 314 . the step 300 , involving the calculation of the amplitude envelope , is shown in further detail in fig1 a through b . a data file stores the digitized sound signals and the file size is read in a step 320 . the number of data points in the file is determined to be equal to the file size divided by 2 in a step 322 . the length of the data processing array is then read from a variable indicator in a step 324 and an overlap length previously set is read in a step 326 . the number of data points to be read from the file is calculated to be equal to the data processing array length minus two times the overlap length in a step 328 . the first two times overlap length of data points in the processing array are packed with zeros in step 330 and the counter is set equal to zero in a step 332 . a determination is made if the envelope smoothing flag is on in a step 334 and if it is , structuring elements are calculated in a step 336 . referring now to fig1 , the number of structuring elements is read in a step 340 and the amplitude of the structuring elements is read in a step 342 . the type of the structuring elements previously determined is read in a step 344 and a type test is made in a step 346 . if the structuring elements are of type 1 they are calculated according to structuring element equal to the amplitude times the size of the quantity i times π over number of structuring elements minus 1 taken from i = zero to the number of structuring elements in a step 348 . if the type from 346 has been set equal to zero , the structuring element is packed with zeros in each of the elements of the array in a step 350 and the routine is exited in a step 352 to transfer control to a step 354 as shown in fig1 a to calculate the filter coefficients . the filter coefficients are calculated in a routine as shown in fig1 where the frequency domain filter coefficients are calculated in a step 370 . step 370 is carried out as shown in fig1 in a step 372 where the hilbert filter coefficient zero is set equal to one and hilbert filter coefficients one through half the data length minus 1 are set equal to two in a step 374 . the next coefficient is set to one in a step 376 . the last hilbert filter coefficients are set equal to zero in a step 378 and return to step 380 to a step 382 shown in fig1 . the request of band pass filtering is tested in 382 and if found to be true , the frequency domain band pass filter coefficients are calculated in a step 384 . in a step 386 each of the hilbert filter coefficients is multiplied by a corresponding band pass filter coefficient to form a final filter coefficient following which the routine is exited in a step 388 to the prior routine . the step 384 is carried out in fig1 wherein a step 400 the sampling frequency , high pass frequency and low pass frequencies previously preset to 4096 , 70 and 1800 hz , respectively , are read . the size of the band pass filter coefficient is determined in a step 402 and normalizing occurs in a step 404 . in steps 406 to 412 the band pass filter coefficients are computed and the routine is exited in a step 414 back to step 386 in the filter coefficient calculation routine shown in fig1 . referring now to fig1 a , the data points are read from the file and placed at the end of the processing array in a step 430 . the counter is incremented in a step 432 and an end of file test is done in a step 434 . if the file processing is ended , the routine is exited in a step 436 . if not , a fourier transform is calculated in a step 438 following which the transformed frequency domain function is multiplied by filter coefficients in a step 440 , as shown in fig1 b . the inverse fourier transform is taken in a step 442 to convert back to the time domain and the instantaneous amplitude of the complex signal is taken by taking the square root of the sum of the squares of the real and imaginary portions of the signal in a step 444 . the signal envelope is set equal to the instantaneous amplitude in step 446 and a test is made in a step 448 . if the test is positive the envelope is smoothed using dilation in a step 450 as may be seen in further detail in fig1 wherein the number of data points of the envelope is read in a step 460 . the size of the structuring element is read in step 462 . the amplitude of the structuring element is read in step 464 and a variable dn is set equal to the structuring element length less one , the whole quantity divided by two in a step 466 . that quantity is assigned to a counter in a step 468 and the counter is incremented in a step 470 . a test is then made to determine whether the number of points is between the original dn number from step 464 or the current counter number in a step 472 . if it is not , the step is returned from in a step 474 . if it is , a supplementary array is loaded in a step 476 . the supplementary array is updated in a step 478 and the i th element of the array is determined in a step 480 following which the routine loops back to the counter in step 470 . in the event that the envelope is not to be smoothed or the step 450 is completed as shown in fig1 b , the last two times the overlap length of data points of processing data array is copied into the beginning of the array in a step 500 . a test is made to determine whether the counter is equal to one in a step 502 . if it is , a number of the data envelope points , equal to the read data points minus the overlap length , starting at two times the overlap length is written to an output file in a step 501 . in the event that the counter is not equal to one the points are written to the output file from the envelope data array starting at envelope element overlap in a step 506 , following which the control is transferred back to step 430 . in order to perform the amplitude threshold determining step for each channel , step 302 shown in fig1 , an amplitude threshold routine is provided as set forth in fig2 . in a step 520 a test is made to determine whether the amplitude threshold has previously been set . if it has , the end position is set equal to the preset in a step 522 , following which the routine is exited in a step 524 . if it has not , the envelope data is read in a step 526 and a histogram of the envelope data is constructed in a step 528 , as shown in greater detail in fig2 . a smoothing moving average filter is applied to the histogram data in the step 530 and the peak on histogram and corresponding envelope value are determined in the step 532 . the average slope of the histogram over data segments of preselected length is determined in a step 534 which is shown in greater detail in fig2 , wherein in a step 540 the first envelope value is determined . in a step 542 the slope is set equal to the current envelope value minus the next envelope value . an end of data test is made in a step 544 . if the end of data has not been reached , the next envelope value is considered in a step 546 following which control is returned to step 542 . if it has not , a moving average filter is applied in a step 548 to smooth the slope , following which the routine is exited in a step 550 , returning control to a step 552 shown in fig2 . when the histogram slope values are scanned starting at the histogram peak and moving in the direction of increasing envelope values to find an envelope value where the slope first becomes positive . upon finding the value when the slope first becomes positive , the amplitude threshold value is set equal to that value in a step 556 and the routine is exited in step 524 . in order to calculate the histogram of the step 528 , as shown in fig2 , all elements of the histogram array are set equal to zero in a step 570 . the add range previously set is read in a step 572 and the first envelope value is considered in step 574 . variable i is set equal to the current envelope value times the quantity 4 , 096 divided by the analog to digital converter range in a step 576 and in a step 578 the i th element of the histogram vector is increased by one step to the next point . an end of data test is made in a step 580 . if the end of data has been reached the routine is exited in return step 582 . if not , control is transferred to a step 584 causing the next envelope value to be considered and then transferring control back to step 576 . after the amplitude threshold for each channel has 35 been found in step 302 , events in each channel must be located using the channel amplitude threshold in the step 304 . this is carried out in the routine shown in fig2 wherein in a step 600 the amplitude threshold value previously calculated is read as is a preset sampling frequency . the variable i 13 strt is set equal to zero in step 604 ; and the variable i 13 dur is set equal to zero in step 606 . first point of the digital envelope data is read in a step 608 and the i 13 strt value is incremented in a step 610 following which an end of file determination is made in a step 612 . if the end of file has been reached control is transferred to a step 614 . if it has not , the envelope value is tested for whether it is greater than the amplitude threshold ; in other words , is there a real reading or a noise reading in a step 616 . if it is not , control is transferred to a test to determine whether i 13 dur is greater than zero in a step 618 . if i 13 dur is not greater than zero , control is transferred back to step 608 , causing the next data point to be read . if i 13 dur is greater than zero , the event number of points is set equal to i 13 dur in the step 620 . the event duration is set equal to the event number of points divided by the sampling frequency in the step 622 and the event duration is saved to disk in a step 624 following which step 606 is executed . if the event value is greater than the great amplitude threshold , control is transferred from step 616 to a step 626 causing the duration variable to be incremented . a test is made to determine whether the duration value variable is equal to one in a step 628 . if it is not , control is transferred back to step 608 . if it is , the starting point of the event is set equal to i 13 start in a step 630 . the event start time is set equal to i 13 start divided by the sampling frequency in a step 632 . the event start time is then saved to disk in a step 634 following which the next point of the digital envelope data is read in a step 608 . in order to perform step 306 where neighboring signals , which are neighboring in time are designated on the same channel signals as belonging to a single gastrointestinal acoustic phenomenon or event , as is shown in fig2 the signals from the first channel are accessed in a step 640 . the first event , which has been previously identified , is accessed in a step 642 . the current event occurrence time and duration previously determined are accessed in a step 644 and the second event in the channel is accessed in a step 646 . the current event occurrence time and durations for the second event are accessed in a step 648 and the event spacing spcg is calculated in a step 650 . in a step 652 if the calculated event spacing is less than a threshold event spacing , control is transferred to a step 654 and the event occurrence time and duration are saved in a step 654 and the second event &# 39 ; s occurrence time and duration are stored as the event occurrence and duration in a step 656 following which in a step 658 the next event is considered . in the event that the spacing is less than the threshold , in a step 660 a new duration is calculated as the sum of the spacing , the second event duration and the original duration , and the next event is then considered in a step 658 . following step 658 a test is made to determine whether any more events are present . if they are not , in step 662 control is transferred to a step 664 , causing the next channel to be analyzed as set forth in the previous steps . a test is then made in a step 666 to determine whether any additional channels need to be analyzed . if there are no more channels to be analyzed , the routine is exited in a step 668 . if there are more channels to be analyzed , control is transferred back to step 642 . in order to find correlated in nearby gastroacoustical phenomenon or events in other channels as set forth in step 308 shown in fig1 , the steps shown in fig2 are performed . the first channel is taken under consideration in the step 670 and in a step 672 , the first event is to be examined . in a step 674 the current event start time and its duration are read and in a step 676 the event time series is read . in addition , in a step 678 the interchannel event delay threshold , which is determined as set forth in fig2 , is read . in a step 680 the search region on other channels is set as well as the search duration which is dependent upon the interchannel event delay threshold . in a step 682 the maximum normalized cross - correlation coefficient and maximum coherence between the events and the sliding window in the search region and in other channels for use in determining the location of maximum on each channel is calculated . in the event that the maximum normalized cross correlation coefficient exceeds a threshold on related events previously set in a step 683 , control is transferred in a step 684 to a step 686 , causing a holding variable to be located with the location of the maximum . in the event the test in the step 684 is negative , control is transferred directly to a step 688 , causing a test to be made to determine whether the maximum coherence between the event and the sliding window in the search region is greater than a threshold on related events . if it is , the second local maximum location is loaded in step 692 . if it is not , control is transferred to a step 690 , causing nearby events to be found and their start times to be saved , as set forth in fig2 and described hereinafter . control is then transferred to a step 700 where the next event is accessed and processed . a test is made in a step 702 for end of file . if end of file has not been reached , control is transferred back to step 674 . if the end of file for that channel has been reached , control is transferred to a step 704 , causing the next channel to be incremented to and a test is made in a step 706 to determine whether any more channel information is available . if it is , control is transferred back to step 672 for further processing . if it is not , control is transferred to a step 708 , following which the routine is exited and control is transferred back to step 310 to determine whether the nearest event is part of a related event . referring now to fig2 , the steps for determining the interchannel event delay threshold , which has been previously applied or set forth therein , in a step 710 the event start time for each of the channels is loaded separately and then consideration is shifted to the first channel in a step 712 . the first event is accessed in a step 714 and current event start time is read in a step 716 . starting at the current event start time a search is made along each of the other channels for the first event to occur and their individual start times are determined . interchannel delays are calculated as being the difference between each of the other channel start times and the current event start time in a step 720 . in a step 722 indexing is done to the next event and a test is made in a step 724 to determine whether any more events are present on that channel . if they are not , control is transferred to a step 726 where indexing is done to the next channel , and a test is made in a step 728 to determine whether any more channels of data are available . if there are more channels of the data , control is transferred back to step 714 . if there are no more channels of data to be processed , a histogram of the interchannel delay is generated in a step 730 . the histogram is smoothed , with a smoothing average filter in a step 732 and a delay value corresponding to the histogram minimum for delay ranging between preset high and low values is determined in a step 734 . the delayed threshold is then set equal to the delay value in a step 736 and routine is exited in a step 738 . in order to find nearby events and save their start times and their amplitudes as required in step 690 appearing on fig2 , the process set forth in fig2 is employed . in a step 740 the interchannel delay threshold previously determined , the current event channel , the start time and the duration are all read . the first channel is considered in the step 742 and in a step 746 other channels starting at the starting time for the first event are searched and the events &# 39 ; start time , duration and amplitude are found . the interchannel delay is then calculated in a step 748 as being the difference between the initial start time and the first event start time . a test is made in a step 750 to determine whether the interchannel delay is less than the interchannel delay threshold . if it is , control is transferred to a step 752 in which a test is made to determine whether the current event duration is greater than the first event duration on the other channel . if the current event duration is greater than the first event duration on the other channel , control is transferred to a step 754 , causing the start time of the first event on the other channel and its amplitude to be saved . if the responses to step 750 and 752 are either in the negative , control is transferred to a step 756 causing the next channel to be accessed and processed . control is then transferred to a step 758 , checking for additional channels to be processed . if there are no more channels the routine is exited in a step 760 . if there are more channels to be processed , control is transferred back to the step 746 . in order to perform the step 310 in which a check is made to determine if the nearest event is part of a related event , the routine set forth in fig2 is carried out . in a step 762 the event start time for each channel is loaded and the first channel is considered in a step 764 . the first event in the current channel is accessed in a step 766 and the current event start time and its duration are read . related event start times are also read , all in a step 768 . the end time for the related events is calculated as a different between the related event start times and the current event start time . beginning at the current event start time , each of the remaining channels is searched for the first events to occur other than related events and their start times and durations are determined . the end time of the nearest detected event is determined in a step 774 and the event overlap on channels is checked in a step 776 as set forth in further detail in fig2 . the next event is considered in a step 778 and a test is made in a step 780 to determine whether there are more events . if there are more events , control is transferred back to step 768 . if there are not , the next channel is accessed in step 782 . an end of channel test is made in a step 784 . if the end of channel &# 39 ; s test indicates further channels are to be processed , control is transferred to a step 766 . if not , the routine is exited in a step 786 . the step 776 is performed as set forth in fig2 . the first channel is considered in a step 788 and the start time and end time of the related events as well as the start time and end time of the detected event are obtained in step 790 from storage . a test is made in a step 792 to determine whether the start time of the related event is greater than the start time of the detected event and whether the start time of the related event is less than the end time of the detected event . if it is , control is transferred to a step 794 , causing the events to be labeled as overlapped . if it is not , control is transferred to a step 796 wherein the end time of the related event is tested to determine whether it is greater than the start time of the detected event together with the end time of the related event being tested to determine whether it is less than the end time of the detected event . if both of those equalities are true , control is transferred to step 794 and the events are labeled as overlapped . if not , control is transferred to step 798 wherein a test is made to determine whether the start time of the related event is less than the start time of the detected event and the end time of the related event is greater than the end time of the detected event . if true , the events are labeled as overlap in step 794 . if not , control is transferred to step 800 and the events are labeled as not overlapped , following which in a step 802 , the next channel is considered . a test is made in a step 804 to determine whether any more channels are to be examined . if they are to be examined , control is transferred back to step 790 . if they are not , the routine is exited in a step 806 . in addition , it is important to characterize the events once they have been identified as set forth in fig1 , in a step 810 a test is made to localize each event followed by which in a step 812 event features are combined , including a start time , duration , amplitude , location , spectrum , morphological characteristics , including attack and delay characteristic , and a transmission transfer function followed by exiting the routine in a step 814 . in order to localize each event , the steps set forth in fig3 are carried out . in order to perform the step 810 as shown in fig3 , the regions of origin are defined in the step 816 , which is shown in more detail in fig3 . the first channel is then considered in a step 818 and the first event on the first channel is accessed in a step 820 . the event start time and peak to peak amplitude are read and the number of related events and the time delay of the related events and the peak to peak amplitudes is also read . if the number of related events is equal to zero as tested for in step 824 , the event location is assigned to the microphone corresponding to the current channel in step 826 and the event has been localized . in the event that the number of the related events is not equal to zero , the origin of the sound region is determined in a step 828 as is more fully set forth in fig3 . a test is made in a step 830 to determine whether the number of related events is greater than one . if it is , the sound source location is determined in a step 832 as more fully set forth in fig3 . in addition , an input is received from a step 834 wherein the transabdominal speed of sound and abdominal damping characteristics have been determined as set forth in fig3 . control is then transferred to the step 836 , causing the next event to be considered . in a step 840 a test is made to determine whether there are any more events . if there are more events , control is transferred back to the step 822 . if not , the next channel is considered in a step 842 . a test is made in a step 834 to determine whether all channels have been processed . if they have not , the channel is incremented and control is transferred back to the step 820 . if they have , the routine is exited in a step 846 . in order to define the regions of origin in step 816 , the number of microphones and their positions are read in a step 850 as shown in fig3 . a midline is determined for each microphone pair in a step 852 and in a step 854 the middle point for each microphone triplet is determined . in a step 856 , the abdominal regions are determined , including the border regions , and in a step 858 the order of arrival corresponding to each region , including equal arrival times , is determined following which the routine is exited in a step 860 . in order to determine the sound region of origin in step 828 , in a step 862 the event order of arrival is read and the event amplitude on each channel is also read , as shown in fig3 . the order of arrival and amplitude information is compared to those of the predetermined regions of origin in a step 864 . in a step 866 an event is assigned to a region of origin on the basis of the comparison and in a step 870 the routine is exited . in order to determine the average transabdominal speed and the abdominal damping characteristics in step 834 , in a step 872 a tape containing prerecorded pure tones and white noise is played through a tape player in a step 874 . that signal is fed through a filter and preamplifier in a step 876 and is boosted by a power amplifier in a step 878 . a shaker coupled to an accelerometer in steps 880 and 882 provides vibration motion to a patient and a pair of transabdominal microphones in a step 886 pick up the resulting vibrational energy . that energy is recorded as electrical signals in a step 888 in a multichannel recorder and is converted in an analog to digital converter in a step 890 and stored in a computer in step 892 . transmitted signals and events are found in a step 894 and a time delay is calculated in a step 896 . the time delay is fed in a step 900 to calculate the frequency dependent trans - abdominal speed of sound and spectral modulation and step 900 also receives the measured distances between the microphones from a step 898 . in order to determine the sound source location after learning the transabdominal speed and abdominal damping characteristics , in a step 902 as shown in fig3 the difference in travel distances of the events are calculated on the basis of the time delay and the average speed of sound obtained from step 834 . in a step 904 , for each microphone pair a hyperbolic curve is determined that describes the locus of sources that would produce the same difference in the sound travel differences . in a step 906 an intersection point of each of the curve pairs is determined and any points that are located outside the abdominal region are excluded from consideration . in a step 908 the middle location of intersection points is determined by averaging their coordinates . in a step 901 the middle point coordinates are assigned to event location coordinates and the routine is exited in a step 912 . in order to combine the event features as set forth in step 812 , the sampling frequency is read in step 914 as shown in fig3 . the start of the event time is read from disk as is the event duration in a step 916 . the event time series is then read from disk in a step 918 , and the spectrum of the event and its dominant frequency are determined in a step 920 . the peak to peak amplitudes and root - mean - square amplitudes of the event are calculated in a step 922 . in a step 924 other event features , including the instantaneous frequency , spectrogram , attack and decay characteristics , spatial event damping and the like are determined from the amplitude envelope and spectrum of the event and from analyzing nearby and related interchannel events and calculating a transmission transfer function . the event transmission speed is also determined . these event features are saved in a step 926 and the routine is exited in a step 928 . recognition of gap events is carried out in the routine shown in fig3 . the event dominant frequency and duration are read in a step 930 and a test is made to determine whether the duration is greater than the minimum . if it is , control is transferred to a step 936 to determine whether the duration is less than the maximum . if it is , determinations are made in steps 938 and 940 to determine whether the dominant frequency is within a predetermined frequency range . in the event none of those tests hold true , control is transferred to a step 936 and the event is labeled as of an unknown kind . in the event that the duration of frequency range is within the windowed limitations , the event is labeled as a possible gastroacoustic phenomenon in step 942 . a test is made in a step 944 to determine whether environmental noise , for instance , from the fourth channel , may have masked gap event and a test is made in a step 946 to recognize vascular events . the routine is then exited in step 948 . in order to perform step 944 to recognize environmental noise or events , the threshold of the interchannel delay for environmental sounds is read in a step 950 , as shown in fig3 . a reading is made to determine if nearby or related labeled events were found in other channels and their interchannel delay times are read in step 952 . in a step 954 , a test is made to determine whether such a related or nearby event was detected on all microphones . if it was not , control is transferred to the return step 960 . if it was , a test is made to determine whether the absolute value of the time delays is less than the interchannel delay for environmental sounds . if not , the routine is exited . if it is , the event label is changed to being one of environmental noise in a step 958 . vascular events are recognized in step 946 , as set forth in fig3 . in a step 962 , the dominant frequency and duration of the event are read and a test is made to determine whether the duration and the dominant frequency are within window values in steps 964 through 970 . if they are not , control is transferred to the return step 982 . if they are , an event spectrum is calculated in a step 972 and normalized . in a step 976 , a series of data related to a library of vascular sound spectra are fed to a step 974 which receives the event spectrum and calculates the deviation of the event spectrum morphology from that of known vascular sounds . if the deviation is less than a spectral threshold value as tested for in step 978 , the routine is exited . if the deviation is greater than or equal to the spectral threshold , the event is labeled as vascular in step 980 and the event is exited . the system is also capable of performing pattern recognition and as set forth in fig3 , a test is made in a step 984 to determine if the patient or subject is a control or has small bowel obstruction or has ileus , as set forth in greater detail in fig4 . in a step 986 , a test is made to determine whether the variables indicate possible inflammatory conditions with location and severity and in a step 988 , diagnostic or probabilities are calculated and output and the routine is exited in a step 990 . the step 984 is carried out as shown in fig4 . in a step 992 the total number of events and the recording duration is read . in a step 994 the average event rate based on the previous value is determined and the dominant frequency and duration of all events is read in a step 996 . the median duration for all events is calculated in step 998 , and the median dominant frequency for all of the events is calculated in a step 1000 . a nearest neighbor classifier receives the average event rate median duration and median dominant frequency and operates on values in a step 1004 , as set forth in further detail in fig4 . the routine is then exited in step 1006 . in order to perform the nearest neighbor classification , the distance in the feature space is calculated between the current subject and prediagnosed subjects in a step 1008 . the nearest preclassified or prediagnosed neighbors are determined in a step 1010 and the current subject class is set to the class of the majority of nearest neighbor preclassified neighbors in a step 1012 . the average distance between a current subject and other members of the same class is determined within the space in a step 1014 and the average distance between the subjects in the same class , excluding the current subject is determined in a step 1016 . the ratio of the subject class distance is then determined in the step 1018 and returned to the step 1020 exiting . referring now to fig4 , a procedure is generally shown therein which may be executed at the microprocessor for filtering multiple channels when a noise estimate is received from a noise channel in a step 1021 , multiple channel signals are accessed and the first channel is accessed in a step 1022 . a noise channel signal is accessed in a step 1024 and the channel selected is filtered adaptively in a step 1026 . the next channel in the step 1028 and the test is done in the step 1030 to determine whether any more channels are available . if more channels are available , step 1026 is returned to . if not , the routine is exited . the step 1026 is shown in further detail in fig4 , wherein in a step 1034 the primary input channel data is stored in an array p and the reference noise channel data from step 1024 is stored into an array nr . the filter order which has been preselected is read in a step 1036 and is divided by two in a step 1038 to provide i 13 p . in a step 1040 the initial filter weights which were set to zero in step 1042 are inputted as is any update filter weights from step 1024 which may have been affected by an adaptation parameter μ . all are provided to step 1040 where in i 13 n is determined as the difference between i 13 p and half of the filter order . the initial filter weights in the updated filter weights , however , are available at step 1040 but are not used in the calculation . in a step 1044 the filtered noise referenced input nf is calculated as the sum of the vector product of the initial or updated filter weights multiplied by the reference noise channel data . an output is calculated in step 1046 related to the difference between the primary input channel data and the reference noise input at that point . in a step 1048 the process is indexed to the next sample and a test is done in a step 1052 to determine whether there are more samples . if there are more samples , the filter weights are updated in a step 1054 on the basis of an adaptation parameter mu , which is doubled and then multiplied by the g output and the noise channel data array . the mu value is preset and the entire quantity is added to the previous filter weights to provide updated filter weights available at step 1040 for calculation of the filtered noise reference input in step 1044 . the system provided outputs in , among other forms , pseudo three - dimensional plots of acoustic frequency event duration and the number of events . for instance , as shown in fig4 , there is a clustering of gap events with a given duration and dominant frequency . these gap events were detected from the epigastraeum of a normal subject . it should be appreciated that the epigastraeum can have long duration events . a subject with ileus had a relatively small number of events and did not have long duration low frequency events as is shown in fig4 . gap events collected from the right lower quadrant of a patient with small bowel obstruction showed a generally downward shifting of dominant frequencies plus very low frequency events in the near right hand corner of the plot as shown in fig4 . tehse were not seen in normal patients or patients having ileus , as shown in fig4 . in fig4 , a pseudo three - dimensional plot is shown of events from the right lower quadrant of a normal subject . the events are characterized by the absence of long duration and low frequency events . in fig4 events taken from the left lower quadrant of a normal subject are similar in characteristic to those shown in fig4 . in fig4 a spectrogram is shown of four events from a normal subject . the events are short and have a dominant frequency at about 500 hz . in fig5 a spectrogram is shown of a subject with small bowel obstruction which is characterized by long event duration and lowering of the dominant frequencies . the bowel sound computerized analysis was performed in the diagnosis of human mechanical small bowel obstruction ( sbo ) after preliminary studies suggested diagnostic gastrointestinal acoustic phenomena ( gap ) changes in a rat sbo model . fifty - three 20 - minute gap recordings were performed in 43 human subjects [ 37 ± 18 ( mean ± sem ) years of age , range 2 - 94 ] using a four - microphone array . recordings were digitized , and each gap event analyzed for spectrum and duration . follow - up was obtained on all patients , who were assigned to 1 of 5 categories : proven sbo by laparotomy or contrast radiography ( 5 ); suspected but unproved sbo ( 3 ); suspected but unproved ileus ( 3 ); definite ileus ( 7 ); and normal fasted controls ( 25 ). the 8 proven and suspected sbo patients had similar findings , demonstrating major consistent differences from the 10 proven and suspected ileus subjects , and both these groups had significant differences from normal controls . values are median ( 25th - 75th %) p values are for sbo - ileus ( s - i ), sbo - control ( s - c ), and ileus - control ( i - c ). beyond the median data , every obstructed patient but no non - obstructed subject demonstrated intermittent very long duration ( 1054 ± 188 ms ) and low frequency ( 168 ± 62 hz ) events (& gt ; 0 . 0001 ). computerized bowel sound analysis may provide a noninvasive method to rapidly and safely diagnose mechanical bowel obstruction and differentiate it from ileus . the auscultory finding of “ high pitched rushes ” with sbo may in fact be “ low pitched rushes .” while there has been illustrated and described a particular embodiment of the present invention , it will be appreciated that numerous changes and modifications will occur to those skilled in the art , and it is intended in the appended claims to cover all those changes and modifications which fall within the true spirit and scope of the present invention .

US-41038299-A

the present invention provides an essentially nonaqueous , liquid pharmaceutical concentrate composition for oral administration containing sertraline or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients . the present invention also provides a use of this concentrate composition to prepare an aqueous solution of sertraline . in addition , the present invention provides a method of using this concentrate composition to treat or prevent a variety of diseases or conditions . finally , the present invention provides the compound , - 4 -- 1 , 2 , 3 , 4 - tetrahydro - n - methyl - 1 - naphthalenamine methanesulfonate .

“ essentially nonaqueous ” when used herein refers to the amount of water that is present in the final drug product , which amount is consistent with the amount of water potentially contributed by the active ingredient and / or by the excipients ; however , no water is directly added to the final drug product . about 10 % is the upper limit of the amount of water that may be present in the oral concentrate of the present invention . typically , the amount of water that is present in the oral concentrate of the present invention ranges from about 0 . 8 % to about 5 . 2 % of the composition . most typically , the amount of water that is present ranges from about 0 . 8 % to about 2 . 0 % of the composition . “ concentrate ” when used herein refers to a strong solution provided for dilution before use . ( butterworths medical dictionary , 2nd edition , butterworths , london - boston 1978 , pp . 399400 .) “ pharmaceutically acceptable excipient ,” as used herein , means a pharmacologically inactive ingredient which is used to formulate a drug product and which is readily known and available in the pharmaceutical arts . examples of such excipients are given below . “ pharmaceutically acceptable preservative ,” as used herein , means an additive or excipient that preserves the quality of the formulation from a chemical or microbiological standpoint . examples of preservatives are given below . “ serotonergic system ” when used herein refers to the neuronal process whereby serotonin is released by a pre - synaptic cell upon excitation and crosses the synapse to stimulate or inhibit the post - synaptic cell . the sertraline oral concentrate of the present invention is a new dosage form of sertraline intended as a multidose product for oral use only . the oral concentrate is an essentially non - aqueous , optionally flavored solution of sertraline , preferably as the hydrochloride salt , which is intended to be diluted prior to administration . the oral concentrate of the present invention is advantageous because , inter alia , it provides convenience in measuring different doses , which are needed for certain indications , and acceptable taste upon administration , as well as good physical / chemical stability characteristics throughout the product &# 39 ; s shelf - life and use interval . also , since the concentrate of the present invention is a solution , it is preferred over a suspension for ease of manufacture and optimal control of dosing homogeneity . the active ingredient in the concentrate of the present invention is sertraline , which may be present as its free base or as its pharmaceutically acceptable salt . such salts include , for example , the hydrochloride salt and the methanesulfonate salt ( also known as the mesylate salt ). in the concentrate of the present invention , the hydrochloride salt is preferred . the preparation of sertraline and its hydrochloride salt is described in the &# 39 ; 518 patent referenced above , particularly in example 2 of that patent . the mesylate salt is prepared by reacting the sertraline free base with methanesulfonic acid at room temperature in a solvent , such as ethyl acetate , methanol , ethanol and isopropanol . the mesylate salt has favorable properties , such as solubility in polar vehicles and good chemical stability . sertraline hydrochloride may be present in the concentrate of the present invention in an amount of about 1 mg / ml up to about 88 mg / ml of the composition . preferably , it is present in an amount of about 15 to about 30 mg / ml of the composition . most preferably , about 20 mg sertraline per ml , which is equivalent to about 22 . 4 mg / ml as the hydrochloride ( assuming a theoretical stoichiometric potency of 89 . 4 %), is present . the quantity of sertraline hydrochloride needed to produce a concentration of about 20 mg sertraline per ml is adjusted based on the actual potency of the drug substance lot to be used . one or more pharmaceutically acceptable excipients are present in the concentrate of the present invention . examples of such excipients include the following : ethanol , glycerin ( also referred to as glycerol or glycerine ), propylene glycol and polyethylene glycols . all of these excipients are well known in the pharmaceutical arts and are commercially available . from among these excipients , binary combinations of ethanol and glycerin provide maximum solubilization of the sertraline hydrochloride drug substance and are preferred . in these combinations , the amount of ethanol that is present is about 8 % to about 50 % ( w / w ) in glycerin ; preferably , about 8 to about 20 % ( w / w ) ethanol in glycerin is present ; most preferably , about 10 to about 14 % ( w / w ) ethanol in glycerin is present . the ethanol that may be used in the concentrate of the present invention is any compendial grade of ethanol , including ethanol ( 95 %) and anhydrous ethanol . the concentrate of the present invention optionally contains one or more flavoring agents or taste - masking flavors . examples of candy - type flavoring agents include mint , citrus and fruit flavoring agents . the mint flavoring agents , such as peppermint , spearmint and menthol ( also referred to as levomenthol ), are preferred . more specifically , from among a variety of mint flavoring agents , menthol is preferred and may be present in an amount of about 0 . 01 to about 5 . 0 mg / ml of the composition ; preferably , menthol is present in an amount of about 0 . 5 mg / ml of the composition . the concentrate of the present invention also optionally contains one or more pharmaceutically acceptable preservatives , which preserve the quality of the concentrate from a chemical or microbiological standpoint . preservatives , such as antioxidants , metal chelators , metal complexing agents and antimicrobial agents , may be used in the concentrate of the present invention . these preservatives may be used in the concentrate , both alone and in various combinations ( e . g ., antioxidant ( s ) in combination with a metal complexing agent ), to improve product stability . when the concentrate of the present invention contains ethanol , it may be appropriately microbiologically self - preserved . examples of preservatives , which may be present in the concentrate of the present invention , include the following : butylhydroxytoluene ( bht , also referrred to as butylated hydroxytoluene ), butylated hydroxyanisole ( bha ), propyl gallate , ascorbic acid , ascorbyl palmitate , sodium metabisulite , sodium bisulfite , sodium thiosulfate , sodium hydroxide , cystiene , ethylenediamine tetraacetic acid ( edta ) or its salts ( such as the sodium salt ), citric acid , triethanolamine , thioglycerol , methylparaben and propylparaben . also , various combinations of these preservatives may be present in the concentrate of the present invention , such as the following : disodium edta and bha ; disodium edta , bha and bht ; disodium edta and propyl gallate ; and bha and bht . the amount of preservative that may be present in the concentrate of the present invention ranges from about 0 . 01 to about 10 . 0 mg / ml of the composition . in the concentrate of the present invention , butylhydroxytoluene ( bht ) is preferred and may be present in an amount of about 0 . 01 to about 0 . 5 mg / ml of the composition ; preferably , it is present in an amount of about 0 . 01 to about 0 . 2 mg / ml of the composition ; more preferably , it is present in amount of about 0 . 01 to about 0 . 13 mg / ml of the composition ; most preferably , it is present in an amount of about 0 . 05 to about 0 . 11 mg / ml of the composition . the sertraline oral concentrate of the present invention is intended to be diluted in a suitable diluent or beverage prior to administration . for example , doses of the oral concentrate ( equivalent to about 25 mg and about 200 mg of sertraline ) are mixed with approximately 4 oz . ( about 120 ml or ½ cup ) of a suitable diluent or beverage . the following beverages may be used for the preparation and administration of the dose : water , orange juice , ginger ale , lemon - lime soda , lemonade , sugared tap water , cranberry juice , grapefruit juice , tomato juice , pineapple juice , prune juice , orange drink and gatorade ® ( beverage , not powder ). water , orange juice , ginger ale , lemon - lime soda and lemonade are preferred . the proper dose of sertraline oral concentrate may be most conveniently added to these beverages by means of a dropper calibrated at , for example , 25 and 50 mg ( as sertraline ). the manufacture of sertraline oral concentrate utilizes conventional pharmaceutical equipment and processes . for example , the manufacturing process for sertraline hydrochloride oral concentrate involves dissolving the sertraline hydrochloride drug substance in a solution of glycerin , ethanol , and optionally other excipients , such as butylhydroxytoluene ( bht ) and menthol , followed by clarifying filtration , if desired , and filling into containers such as bottles , as appropriate . preferably , to facilitate bht incorporation , this component is first dissolved in a portion of the ethanol , which is then added to the main compounding tank containing the glycerin and the remainder of the ethanol . menthol and sertraline hydrochloride are then sequentially added and mixed to dissolve . the sertraline hydrochloride is intentionally added to the solution last to optimize the protective effect of the antioxidant ( bht ). the compounded solution is passed through a filter , and the final product is filled into appropriate containers , such as bottles . the final product may be supplied in a variety of presentations , such as a 60 ml presentation , which is packaged in , for example , a 60 ml , amber glass bottle with a child - resistant closure . % w / v ingredients mg / ml ( g / 100 ml ) mg / 60 ml sertraline hcl 22 . 37 2 . 237 1342 . 3 ethanol ( 95 %) 150 . 68 15 . 068 9040 . 8 menthol 0 . 50 0 . 050 30 . 0 bht 0 . 10 0 . 010 6 . 0 glycerin 1010 . 81 101 . 081 60648 . 6 total 1184 . 46 118 . 446 71067 . 7 bht , menthol and drug were dissolved in a mixture of glycerin and ethanol . the resulting mixture may be blanketed with nitrogen due to the ethanol content and associated potential flammability . the resulting mixture may be filtered , if desired . one ml of a nonaqueous solution containing 1 - 23 mg sertraline hcl / ml : one ml of a nonaqueous solution containing 1 - 64 mg sertraline hcl / ml : one ml of a nonaqueous solution containing 1 - 17 mg sertraline hcl / ml : one ml of a nonaqueous solution containing 1 - 78 mg sertraline hcl / ml : dissolve the drug substance in a mixture of ethanol and glycerin with stirring . dissolve the natural peppermint stick flavoring and drug in a mixture of ethanol and glycerin . dissolve the menthol and drug in a mixture of ethanol and glycerin . 1000 ml concentrate solution ( 20 mg sertraline / ml ) with preservatives and peppermint flavoring : the natural peppermint stick flavoring , parabens and drug were dissolved in a mixture of ethanol / glycerin . 1000 ml concentrate solution ( 20 mg sertraline / ml ) with preservatives and no flavoring : the parabens and drug were dissolved in a mixture of ethanol / glycerin . the following examples describe various 1000 ml concentrate solutions of sertraline hydrochloride ( 20 mg sertraline / ml ) with preservatives and menthol flavoring : for examples 10 - 30 above , the menthol and preservative were dissolved in ethanol .

US-77198504-A

a personal vapor inhaling unit is disclosed . an electronic flameless vapor inhaler unit that may simulate a cigarette has a cavity that receives a cartridge in the distal end of the inhaler unit . the cartridge brings a substance to be vaporized in contact with a wick . when the unit is activated , and the user provides suction , the substance to be vaporized is drawn out of the cartridge , through the wick , and is atomized by the wick into a cavity containing a heating element . the heating element vaporizes the atomized substance . the vapors then continue to be pulled by the user through a mouthpiece and mouthpiece cover where they may be inhaled .

in an embodiment a personal vaporizer unit comprises a mouthpiece configured for contact with the mouth of a person . at least part of this mouthpiece has an antimicrobial surface . this mouthpiece may also comprise silicone rubber , thermoplastic elastomer , organosilane , silver impregnated polymer , silver impregnated thermoplastic elastomer , and / or polymer . the mouthpiece may be removed from the personal vaporizing for washing or replacement , without using a tool . the mouthpiece may be provided in different colors . designs or other patterns may be visible on the outside of the mouthpiece . in an embodiment , a personal vaporizer unit comprises a first conductive surface configured to contact a first body part of a person holding the personal vaporizer unit , and a second conductive surface , conductively isolated from the first conductive surface , configured to contact a second body part of the person . when the personal vaporizer unit detects a change in conductivity between the first conductive surface and the second conductive surface , a vaporizer is activated to vaporize a substance so that the vapors may be inhaled by the person holding unit . the first body part and the second body part may be a lip or parts of a hand ( s ). the two conductive surfaces may also be used to charge a battery contained in the personal vaporizer unit . the two conductive surfaces may also form , or be part of , a connector that may be used to output data stored in a memory . in an embodiment , a personal vaporizer unit comprises a chamber configured to receive a cartridge . the cartridge may hold a substance to be vaporized . the chamber may be configured at the distal end of the personal vaporizer unit . a user may inhale the vaporized substance at the proximal end of the personal vaporizer unit . at least one space between the exterior surface of the cartridge , and an interior surface of the chamber , may define a passage for air to be drawn from outside the personal vaporizer unit , near the distal end , through the personal vaporizer unit to be inhaled by the user along with the vaporized substance . the personal vaporizer unit may also include a puncturing element that breaks a seal on the cartridge to allow a substance in the cartridge to be vaporized . an end surface of the cartridge may be translucent to diffuse light produced internally to the personal vaporizer unit . the translucent end may be etched or embossed with letters , symbols , or other indicia that are illuminated by the light produced internally to the personal vaporizer unit . in an embodiment , a personal vaporizer unit comprises a first wick element and a second wick element having a porous ceramic . the first wick element is adapted to directly contact a liquid held in a reservoir . the reservoir may be contained by a cartridge that is removable from the personal vaporizer unit . a heating element is disposed through the second wick element . an air gap is defined between the first wick element and the second wick element with the heating element exposed to the air gap . air enters the first wick element through a hole in a housing holding the first wick element . in an embodiment , a personal vaporizer unit comprises a light source internal to an opaque cylindrical housing that approximates the appearance of a smoking article . a cylindrical light tube is disposed inside the opaque cylindrical housing to conduct light emitted by the light source to an end of the opaque cylindrical housing . this allows the light to be visible outside of the opaque cylindrical housing of the vaporizer . in an embodiment , a personal vaporizer unit comprises a microprocessor , memory , and a connector . the connector outputs data stored in the memory . the microprocessor may gather , and store in the memory , information including , but not limited to , the number of cycles the device has been triggered , the duration of the cycles , the number cartridges of fluid that are delivered . the microprocessor may also gather and store times and dates associated with the other information gathered and stored . the microprocessor may detect an empty cartridge by detecting a specific change in resistance between a wick and a housing that is equivalent to a “ dry wick ”, and thus signifies an empty cartridge . in an embodiment , a case comprises a cradle adapted to hold a personal vaporizer unit . the personal vaporizer unit has dimensions approximating a smoking article . the case includes a battery and at least two contacts . the two contacts may form an electrical contact with the personal vaporizer unit when the personal vaporizer unit is in the cradle . the two contacts may conduct charge from the battery to the personal vaporizer unit to charge the personal vaporizer unit . the case may also download and store data retrieved from the personnel vaporizing unit . the case may download and store this data via the at least two contacts . the case may send this data to a computer via wired or wireless links . the case may have more than one cradle and sets of contacts ( e . g ., two sets of two contacts in order to hold and charge two personal vaporizer units ). fig1 is a perspective view of a personal vaporizer unit . in fig1 , personal vaporizer unit 100 comprises outer main shell 102 , mouthpiece cover 114 , mouthpiece 116 , and mouthpiece insulator 112 . the mouthpiece 116 and mouthpiece cover 114 define the proximal end of personal vaporizer unit 100 . the opposite end of personal vaporizer unit 100 will be referred to as the distal end . a cartridge 150 may be inserted into the distal end of personal vaporizer unit 100 . cartridge 150 may hold the substance to be vaporized by personal vaporizer unit 100 . the substance after vaporizing may be inhaled by a user holding the personal vaporizer unit 100 . the substance may be in the form of a liquid or gel . fig2 is a side view of a personal vaporizer unit . fig2 illustrates personal vaporizer unit 100 as viewed from the side . fig2 illustrates personal vaporizer unit 100 comprising outer main shell 102 , mouthpiece cover 114 , mouthpiece 116 , and mouthpiece insulator 112 . fig2 also illustrates cartridge 150 inserted into the distal end of personal vaporizer unit 100 . fig3 is an end view of the proximal end of a personal vaporizer unit . fig3 shows the proximal end view of personal vaporizer unit 100 comprising mouthpiece cover 114 . fig4 is an end view of the distal end of a personal vaporizer unit . fig4 shows the distal end view personal vaporizer unit 100 comprising the visible portion of cartridge 150 . fig4 a is an alternative end view of personal vaporizer unit 100 comprising a visible portion of cartridge 150 that has visible logos , letters , or other symbols . these visible logos , letters , or other symbols may be illuminated or backlit by a light source internal to the personal vaporizer unit 100 . the light source may be activated intermittently under the control of a microprocessor or other electronics internal to personal vaporizer unit 100 . the light source may be activated in such a manner as to simulate the glowing ash of a cigar or cigarette . fig5 is a figure map of fig6 and 7 . fig6 is a cross - section of the proximal portion of a personal vaporizer unit along the cut line shown in fig2 . in fig6 , the proximal portion of personal vaporizer unit 100 comprises mouthpiece cover 114 , mouthpiece 116 , mouthpiece insulator 112 , outer main shell 102 , battery support 106 , and battery 104 . the mouthpiece cover 114 surrounds and is engaged with the distal end of mouthpiece 116 . mouthpiece 116 and outer main shell 102 are preferably made of an electrically conductive material ( s ). mouthpiece 116 is separated from outer main shell 102 by mouthpiece insulator 112 . mouthpiece 116 and outer main shell 102 are thus electrically isolated from each other by mouthpiece insulator 112 . in an embodiment , personal vaporizer unit 100 is configured such that other main shell 102 comprises a first conductive surface configured to contact a first body part of a person holding personal vaporizer unit 100 . mouthpiece 116 comprises a second conductive surface , which is conductively isolated from the first conductive surface . this second conductive surface is configured to contact a second body part of the person . when personal vaporizer unit 100 detects a change in conductivity between the first conductive surface and the second conductive surface , a vaporizer internal to personal vaporizer unit 100 is activated to vaporize a substance in cartridge 150 so that the vapors may be inhaled by the person holding personal vaporizer unit 100 . the first body part and the second body part may be a lip or parts of a hand ( s ). the two conductive surfaces of outer main shell 102 and mouthpiece 116 , respectively , may also be used to charge battery 104 contained in the personal vaporizer unit 100 . the two conductive surfaces of outer main shell 102 and mouthpiece 116 , respectively , may also be used to output ( or input ) data stored ( or to be stored ) in a memory ( not shown ). battery support 106 functions to hold battery 104 in a position which is fixed relative to our main shell 102 . battery support 106 is also configured to allow air and vaporized substance to pass from the distal end of personal vaporizer unit 100 past battery 104 along one or more passageways . after air and the vapors of the vaporized substance pass by battery 104 , they may pass through openings in mouthpiece 116 , mouthpiece cover 114 , and mouthpiece insulator 112 , to be inhaled by a user . fig7 is a cross - section of the distal portion of a personal vaporizer unit along the cut line shown in fig2 . in fig7 , the distal end portion of personal vaporizer unit 100 comprises outer main shell 102 , light pipe sleeve 140 , and atomizer housing 132 , distal wick 134 , proximal wick 136 , pc board 123 , pc board 124 , spacer 128 , and main housing 160 . fig7 also illustrates cartridge 150 inserted into the distal end of personal vaporizer unit 100 . as can be seen in fig7 , cartridge 150 may hold a substance ( e . g ., a liquid or gel ) in direct contact with distal wick 134 . the substance may be drawn through distal wick 134 to be vaporized inside atomizer assembly . the atomizer assembly comprises atomizer housing 132 , distal wick 134 , proximal wick 136 , and a heating element ( not shown ). fig8 is an exploded side view of components of a personal vaporizer unit . fig9 is an exploded cross - section of components of a personal vaporizer unit along the cut line shown in fig2 . in fig8 and 9 , personal vaporizer unit 100 comprises ( from left to right ) mouthpiece cover 114 , mouthpiece 116 , mouthpiece insulator 112 , battery 104 , battery support 106 , pc board 123 , spacer 128 , pc board 124 , main housing 160 , proximal wick 136 , distal wick 134 , atomizer housing 132 , light pipe sleeve 140 , and cartridge 150 . mouthpiece cover 114 surrounds and covers the proximal end of mouthpiece 116 . the distal end of mouthpiece 116 is inserted into mouthpiece insulator 112 . battery 104 is held in place by battery support 106 . pc board 123 , spacer 128 and pc board 124 are disposed within main housing 160 . proximal wick 136 and distal wick 134 are disposed within atomizer housing 132 . atomizer housing 132 ( and therefore proximal wick 136 , distal wick 134 ) are disposed inside light pipe sleeve 140 and main shell 102 . ( note : for clarity , main shell 102 is not shown in fig8 and 9 .) light pipe sleeve 140 is disposed within main shell 102 . light pipe sleeve 140 is positioned such that light emitted from a light source mounted on pc board 124 may be conducted via light pipe sleeve 140 to a location where it is visible on the outside of personal vaporizer unit 100 . cartridge 150 is disposed within light pipe sleeve 140 . when assembled , a substance contained within cartridge 150 is held in direct contact with distal wick 134 . when cartridge 150 is inserted into personal vaporizer unit 100 atomizer housing 132 or distal wick 134 may puncture a seal or cap that contains the substance to be vaporized within cartridge 150 . once punctured , the substance held within a reservoir of cartridge 150 may come in direct contact with distal wick 134 . fig1 is a perspective view of a mouthpiece cover of a personal vaporizer unit . fig1 is a distal end view of the mouthpiece cover of fig1 . fig1 is a cross - section of the mouthpiece cover along the cut line shown in fig1 . as can be seen in fig1 - 12 , mouthpiece cover 114 has an opening 114 - 1 that allows air and the vaporized substance to be drawn through mouthpiece cover 114 . mouthpiece cover 114 is configured for contact with the mouth of a person . in an embodiment , at least part of the mouthpiece cover has an antimicrobial surface . this antimicrobial surface of mouthpiece cover 114 may comprise , but is not limited to : silicone rubber , thermoplastic elastomer , organosilane , silver impregnated polymer , silver impregnated thermoplastic elastomer , and / or polymer . mouthpiece cover 114 is also configured to be removable from personal vaporizer unit 100 by a user without the use of tools . this allows mouthpiece cover 114 to be replaced and / or washed . in an embodiment , mouthpiece cover 114 may be held in place on personal vaporizer unit 100 by annular ridge 114 - 2 which interfaces with a groove on mouthpiece 116 of personal vaporizer unit 100 to secure mouthpiece cover 114 in place . in another embodiment , mouthpiece cover 114 may be held in place on personal vaporizer unit 100 by a friction fit . fig1 is a perspective view of a mouthpiece of a personal vaporizer unit . fig1 is a side view of the mouthpiece of fig1 . fig1 is a cross - section of the mouthpiece along the cut line shown in fig1 . as can be seen in fig1 - 15 , mouthpiece 116 has a passageway 116 - 1 that allows air and the vaporized substance to be drawn through mouthpiece 116 . mouthpiece 116 may comprise a conductive surface or material configured to contact a first body part of a person holding personal vaporizer unit 100 . this first body part may be part of a hand , or at least one lip of the person holding personal vaporizer unit 100 . in an embodiment , mouthpiece 116 has an annular groove 116 - 2 around an outside surface . this groove is configured to receive annular ridge 114 - 2 . thus , annular groove 116 - 2 helps secure mouthpiece cover 114 to personal vaporizer unit 100 . fig1 is a perspective view of a mouthpiece insulator of a personal vaporizer unit . fig1 is a distal end view of the mouthpiece insulator of fig1 . fig1 is a side view of the mouthpiece insulator of fig1 . fig1 is a cross - section of the mouthpiece insulator along the cut line shown in fig1 . as discussed previously , mouthpiece insulator 112 is disposed between main shell 102 and mouthpiece 116 . as can be seen in fig1 - 18 , mouthpiece insulator 112 has a passageway 112 - 1 that allows air and the vaporized substance to be drawn through mouthpiece insulator 112 . because mouthpiece insulator 112 is disposed between main shell 102 and mouthpiece 116 , mouthpiece insulator 112 can electrically isolate main shell 102 and mouthpiece 116 . thus , in an embodiment , mouthpiece insulator 112 comprises , or is made of , a non - electrically conductive material . this electrical isolation between main shell 102 and mouthpiece 116 allow electrical impedance changes between main shell 102 and mouthpiece 116 to be detected . for example , a first conductive surface on mouthpiece 116 may be configured to contact a first body part of a person holding personal vaporizer unit 100 . a second conductive surface on main shell 102 ( which is conductively isolated from said first conductive surface by mouthpiece insulator 112 ) may be configured to contact a second body part of the person . personal vaporizer unit 100 may then activate in response to detecting a change in conductivity between the first conductive surface and the second conductive surface . in an embodiment , this change in conductivity may comprise a drop in impedance between the first conductive surface and the second conductive surface . in an embodiment , the change in conductivity may comprise a change in capacitance between the first conductive surface and the second conductive surface . the first body part may be a finger . the second body part may be a lip . the second body part may be a second finger . in an embodiment , the first conductive surface and the second conductive surfaces may be used to pass a charging current to battery 104 . the first and second conductive surfaces may also be used to transfer data to or from personal vaporizer unit 100 . fig2 is a perspective view of a main housing of a personal vaporizer unit . fig2 is a distal end view of the main housing of fig2 . fig2 is a proximal end view of the main housing of fig2 . fig2 is a side view of the main housing of fig2 . fig2 is a cross - section of the main housing along the cut line shown in fig2 . main housing 160 is configured to hold pc - boards 123 and 124 , and spacer 128 . main housing 160 is configured to fit within main shell 102 via a friction fit . main housing 160 has several holes 166 that allow light generated by a light source ( s ) on pc - board 124 to pass . once this light passes through holes 166 , it may be coupled into light pipe sleeve 140 where it is conducted to a visible location on the outside of personal vaporizer unit 100 . main housing 160 also has a hole 165 that allows an electrical conductor ( not shown ) to run from pc - board 123 or pc - board 124 through main housing 160 . this electrical conductor may be , or connect to , a heating element ( not shown ). this heating element may help vaporize the substance to be inhaled by the user of personal vaporizer unit 100 . this heating element may be controlled by circuitry on pc - board 123 or pc - board 124 . this heating element may be activated in response to a change in conductivity between the first conductive surface and the second conductive surface , described previously . the exterior of main housing 160 may also have a flat surface 164 ( or other geometry ) forming a galley that is configured to allow the vaporized substance and air to pass between the main housing 160 and the main shell 102 . once the vaporized substance and air pass by main housing 160 , they may travel through passageway 112 - 1 , passageway 116 - 1 , and opening 114 - 1 to be inhaled by a user of personal vaporizer unit 100 . the exterior of main housing 160 may also have one or more standoffs 167 ( or other geometries ) that are configured to allow air and the vaporized substance to reach the passageway formed by flat surface 164 and main shell 102 . fig2 is a perspective view of a main housing of a personal vaporizer unit . fig2 is a second perspective view of the main housing of fig2 . fig2 is a distal end view of the main housing of fig2 . fig2 is a proximal end view of the main housing of fig2 . fig2 is a side view of the main housing of fig2 . fig3 is a cross - section of the main housing along the cut line shown in fig2 . main housing 260 may be used as an alternative embodiment to main housing 160 . main housing 260 is configured to hold pc - boards 123 and 124 , and spacer 128 . main housing 260 is configured to fit within main shell 102 via a friction fit . main housing 260 has several holes 266 that allow light generated by a light source ( s ) on pc - board 124 to pass . once this light passes through holes 266 , it may be coupled into light pipe sleeve 140 where it is conducted to a visible location on the outside of personal vaporizer unit 100 . main housing 260 also has a hole 265 that allows an electrical conductor ( not shown ) to run from pc - board 123 or pc - board 124 through main housing 260 . this electrical conductor may be , or connect to , a heating element ( not shown ). this heating element may help vaporize the substance to be inhaled by the user of personal vaporizer unit 100 . this heating element may be controlled by circuitry on pc - board 123 or pc - board 124 . this heating element may be activated in response to a change in conductivity between the first conductive surface and the second conductive surface , described previously . the exterior of main housing 260 may also have flat surfaces 264 ( or other geometry ) that form a galley that is configured to allow the vaporized substance and air to pass between the main housing 260 and the main shell 102 . once the vaporized substance and air pass by main housing 260 , they may travel through passageway 112 - 1 , passageway 116 - 1 , and opening 114 - 1 to be inhaled by a user of personal vaporizer unit 100 . the exterior of main housing 260 may also have one or more standoffs 267 ( or other geometries ) that are configured to allow air and the vaporized substance to reach the passageway formed by flat surfaces 264 and main shell 102 . fig3 is a perspective view of a printed circuit board assembly of a personal vaporizer unit . fig3 is a distal end view of the pcb assembly of fig3 . fig3 is a perspective exploded view of the pcb assembly of fig3 . fig3 is a side exploded view of the pcb assembly of fig3 . as can be seen in fig3 - 34 , the pcb assembly is comprised of pc - board 123 and pc - board 124 separated by a spacer 128 . pc - board 124 may have mounted upon it light emitting diodes ( leds ) 125 - 127 or other light sources . leds 125 - 127 are configured and positioned such that when they produce light , that light passes through holes 166 or 266 in main housings 160 and 260 , respectively . this light may then be conducted by light pipe sleeve 140 to a location where it will be visible exterior to personal vaporizer unit 100 . pc - board 123 may have mounted on it a microprocessor , memory , or other circuitry ( not shown ) to activate or otherwise control personal vaporizer unit 100 . this microprocessor may store data about the operation of personal vaporizer unit 100 in the memory . for example , the microprocessor may determine and store the number of cycles personal vaporizer unit 100 has been triggered . the microprocessor may also store a time and / or date associated with one or more of these cycles . the microprocessor may cause this data to be output via a connector . the connector may be comprised of the first and second conductive surfaces of mouthpiece 116 and / or main shell 102 . in an embodiment , the microprocessor may determine a duration associated with various cycles where personal vaporizer unit 100 has been triggered . these durations ( or a number based on these duration , such as an average ) may be stored in the memory . the microprocessor may cause these numbers to be output via the connector . the microprocessor may determine an empty cartridge condition and stores a number associated with a number of times said empty cartridge condition occurs . the microprocessor , or other circuitry , may determine an empty cartridge condition determined based on a resistance between atomizer housing 132 or 232 and a wick 134 , 234 , 136 , or 236 . the microprocessor may also store a time and / or date associated with one or more of these empty cartridge conditions . the number of times an empty cartridge condition is detected , and or times and / or dates associated with these empty cartridge conditions may be output via the connector . battery 104 , pc - board 123 , pc - board 124 , and all electronics internal to personal vaporizer unit 100 may be sealed in a plastic or plastic and epoxy compartment within the device . this compartment may include main housing 160 or 260 . all penetrations in this compartment may be sealed . thus , only wires will protrude from the compartment . the compartment may be filled with epoxy after the assembly of battery 104 , pc - board 123 , pc - board 124 , and leds 125 - 127 . the compartment may be ultrasonically welded closed after assembly of battery 104 , pc - board 123 , pc - board 124 , and leds 125 - 127 . this sealed compartment is configured such that all vapor within personal vaporizer unit 100 does not come in contact with the electronics on pc - boards 123 or 124 . fig3 is a perspective view of a proximal wick element of a personal vaporizer unit . fig3 a is a perspective view of a heating element disposed through a proximal wick element of a personal vaporizer unit . fig3 b is a perspective view of a heating element of a personal vaporizer unit . fig3 is a distal end view of the wick element of fig3 . fig3 is a cross - section of the wick element along the cut line shown in fig3 . proximal wick 136 is configured to fit within atomizer housing 132 . as can be seen in fig3 - 37 , proximal wick 136 includes internal wire passageway 136 - 1 and external wire passageway 136 - 2 . these wire passageways allows a conductor or a heating element 139 to be positioned through proximal wick 136 ( via internal wire passageway 136 - 1 ). this conductor or heating element 139 may also be positioned in external wire passageway 136 - 2 . thus , as shown in fig3 a , a conductor or heating element 139 may be wrapped around a portion of proximal wick 136 by running the conductor or heating element 139 through internal wire passageway 136 - 1 , around the distal end of proximal wick 136 , and through external wire passageway 136 - 2 to return to approximately its point of origin . the heating element 139 may , when personal vaporizer 100 is activated , heat proximal wick 136 in order to facilitate vaporization of a substance . fig3 is a perspective view of a distal wick element of a personal vaporizer unit . fig3 is a distal end view of the wick element of fig3 . fig4 is a cross - section of the wick element along the cut line shown in fig3 . distal wick 134 is configured to fit within atomizer housing 132 . as can be seen in fig3 - 40 , distal wick 134 comprises two cylinders of different diameters . a chamfered surface transitions from the smaller diameter of the distal end of distal wick 134 to a larger diameter at the proximal end of distal wick 134 . the cylinder at the distal end terminates with a flat surface end 134 - 1 . this flat surface end 134 - 1 is the end of distal wick 134 is a surface that is placed in direct contact with a substance to be vaporized when cartridge 150 is inserted into the distal end of personal vaporizer 100 . the proximal end of distal wick 134 is typically in contact with proximal wick 136 . however , at least a part of proximal wick 136 and distal wick 134 are separated by an air gap . when distal wick 134 and proximal wick 136 are used together , this air gap is formed between distal wick 134 and proximal wick 136 by stand offs 136 - 3 as shown in fig3 . fig4 is a perspective view of a distal wick element of a personal vaporizer unit . fig4 is a distal end view of the wick element of fig4 . fig4 is a cross - section of the wick element along the cut line shown in fig4 . proximal wick 234 may be used as an alternative embodiment to distal wick 134 . proximal wick 234 is configured to fit within atomizer housing 232 . as can be seen in fig4 - 43 , proximal wick 234 comprises two cylinders of different diameters , and a cone or pointed end 234 - 1 . a chamfered surface transitions from the smaller diameter of the distal end of proximal wick 234 to a larger diameter at the proximal end of proximal wick 234 . the cylinder at the distal end terminates with a pointed end 234 - 1 . this pointed end 234 - 1 is the end of proximal wick 234 that is in direct contact with a substance to be vaporized . this pointed end 234 - 1 may also break a seal on cartridge 150 to allow the substance to be vaporized to come in direct contact with proximal wick 234 . the proximal end of proximal wick 234 is typically in contact with proximal wick 136 . however , at least a part of proximal wick 136 and proximal wick 234 are separated by an air gap . when distal wick 134 and proximal wick 236 are used together , this air gap is formed between proximal wick 234 and proximal wick 136 by stand offs 136 - 3 as shown in fig3 . fig4 is a perspective view of an atomizer housing of a personal vaporizer unit . fig4 is a distal end view of the atomizer housing of fig4 . fig4 is a side view of the atomizer housing of fig4 . fig4 is a top view of the atomizer housing of fig4 . fig4 is a cross - section of the atomizer housing along the cut line shown in fig4 . atomizer housing 132 is configured to fit within main shell 102 . as can be seen in fig4 - 48 , atomizer housing 132 comprises roughly two cylinders of different diameters . a chamfered surface 132 - 3 transitions from the smaller diameter of the distal end of atomizer housing 132 to a larger diameter at the proximal end of atomizer housing 132 . the larger diameter at the proximal end of atomizer housing 132 is configured to be press fit into light pipe sleeve 140 . the cylinder at the distal end terminates with a spade shaped tip 132 - 2 . this spade shaped tip 132 - 2 may break a seal on cartridge 150 to allow the substance to be vaporized to come in direct contact with distal wick 134 . other shaped tips are possible ( e . g ., needle or spear shaped ). chamfered surface 132 - 3 has one or more holes 132 - 1 . these holes allow air to pass , via suction , through atomizer housing 132 into distal wick 134 . this suction may be supplied by the user of personal vaporizer 100 sucking or inhaling on mouthpiece cover 114 and / or mouthpiece 116 . the air that is sucked into distal wick 134 enters distal wick 134 on or near the chamfered surface between the two cylinders of distal wick 134 . the air that is sucked into distal wick 134 displaces some of the substance being vaporized that has been absorbed by distal wick 134 causing it to be atomized as it exits distal wick 134 into the air gap formed between distal wick 134 and proximal wick 136 . the heating element disposed around proximal wick 136 may then vaporize at least some of the atomized substance . in an embodiment , one or more holes 132 - 1 may range in diameter between 0 . 02 and 0 . 0625 inches . in an embodiment , placing holes 132 - 1 at the leading edge of the chamfered surface places a set volume of the substance to be vaporized in the path of incoming air . this incoming air has nowhere to go but through the large diameter ( or “ head ”) end of the distal end wick 134 . when the air enters this area in distal end wick 134 it displaces the substance to be vaporized that is suspended in distal end wick 134 towards an air cavity between distal end wick 134 and proximal end wick 136 . when the displaced substance to be vaporized reaches the surface of distal end wick 134 , it is forced out of the wick by the incoming air and the negative pressure of the cavity . this produces an atomized cloud of the substance to be vaporized . in an embodiment , the diameter of the head of distal end wick 134 may be varied and be smaller than the diameter of the proximal end wick 136 . this allows for a tuned volume of air to bypass proximal end wick 136 and directly enter the cavity between distal wick 134 and distal wick 136 without first passing through distal wick 136 . fig4 is a perspective view of an atomizer housing of a personal vaporizer unit . fig5 is a distal end view of the atomizer housing of fig4 . fig5 is a side view of the atomizer housing of fig4 . fig5 is a top view of the atomizer housing of fig4 . fig5 is a cross - section of the atomizer housing along the cut line shown in fig5 . atomizer housing 232 is an alternative embodiment , for use with proximal wick 234 , to atomizer house 132 . atomizer housing 232 is configured to fit within main shell 102 and light pipe sleeve 140 . as can be seen in fig4 - 53 , atomizer housing 232 comprises roughly two cylinders of different diameters . a chamfered surface 232 - 3 transitions from the smaller diameter of the distal end of atomizer housing 232 to a larger diameter at the proximal end of atomizer housing 232 . the larger diameter at the proximal end of atomizer housing 232 is configured to be press fit into light pipe sleeve 140 . the cylinder at the distal end terminates with an open cylinder tip 232 - 2 . this open cylinder tip 232 - 2 allows the pointed end 234 - 1 of proximal wick 234 to break a seal on cartridge 150 to allow the substance to be vaporized to come in direct contact with proximal wick 234 . chamfered surface 232 - 3 has one or more holes 232 - 1 . these holes allow air to pass , via suction , through atomizer housing 232 into proximal wick 234 . the air that is sucked into proximal wick 234 enters proximal wick 234 on or near the chamfered surface between the two cylinders of proximal wick 234 . the air that is sucked into proximal wick 234 displaces some of the substance being vaporized that has been absorbed by proximal wick 234 causing it to be atomized as it exits proximal wick 234 into the air gap formed between proximal wick 234 and proximal wick 136 . the heating element disposed around proximal wick 136 may then vaporize at least some of the atomized substance being vaporized . in an embodiment , one or more holes 232 - 1 may range in diameter between 0 . 02 and 0 . 0625 inches . in an embodiment , placing holes 232 - 1 at the leading edge of the chamfered surface places a set volume of the substance to be vaporized in the path of incoming air . this incoming air has nowhere to go but through the head of the distal end wick 234 . when the air enters this area in distal end wick 234 it displaces the substance to be vaporized that is suspended in distal end wick 234 towards an air cavity between distal end wick 234 and proximal end wick 236 . when the displaced substance to be vaporized reaches the surface of distal end wick 232 , it is forced out of the wick by the incoming air and the negative pressure of the cavity . this produces an atomized cloud of the substance to be vaporized . in an embodiment , the diameter of the head of distal end wick 234 may be varied and be smaller than the diameter of the proximal end wick 236 . this allows for a tuned volume of air to bypass distal wick 236 and directly enter the cavity between proximal wick 234 and distal wick 236 without first passing through distal wick 236 . fig5 is a perspective view of an atomizer housing and wicks of a personal vaporizer unit . fig5 is an exploded view of the atomizer housing , wire guides , and wicks of fig5 . fig5 is a side view of the atomizer housing and wicks of fig5 . fig5 is a distal end view of the atomizer housing and wicks of fig5 . fig5 is a cross - section of the atomizer housing and wicks along the cut line shown in fig5 . the atomizer housing and wicks shown in fig5 - 58 is an alternative embodiment for use with proximal wick 236 . the embodiment shown in fig5 - 58 use atomizer housing 232 , proximal wick 234 , proximal wick 236 , wire guide 237 , and wire guide 238 . proximal wick 236 is configured to fit within atomizer housing 232 . as can be seen in fig5 - 58 , proximal wick 236 includes internal wire passageway 236 - 1 . this wire passageway 236 - 1 allows a conductor or a heating element ( not shown ) to be positioned through proximal wick 236 ( via internal wire passageway 236 - 1 ). the conductor or heating element may be positioned around wire guide 237 and wire guide 238 . thus , a conductor or heating element may run the through wire passageway 236 - 1 , around wire guides 237 and 238 , and then back through wire passageway 236 - 1 to return to approximately its point of origin . the heating element may , when personal vaporizer unit 100 is activated , heat proximal wick 236 in order to facilitate vaporization of a substance . fig5 is a perspective view of the proximal end wick assembly of fig5 - 58 . fig5 a is a perspective view showing a heating element disposed through the proximal end wick and around the wire guides of fig5 - 58 . fig5 b is a perspective view of the heating element of a personal vaporizer unit . fig6 is a distal end view of the wick element and wire guides of fig5 - 58 . fig6 is a cross - section of the wick element and wire guides along the cut line shown in fig6 . as can be seen in fig5 a , a conductor or heating element 239 may run through wire passageway 236 - 1 , around wire guides 237 and 238 , and then back through wire passageway 236 - 1 to return to approximately its point of origin . in an embodiment , distal wicks 134 , 234 , and proximal wicks 136 , 236 , may be made of , or comprise , for example a porous ceramic . distal wicks 134 , 234 , and proximal wicks 136 , 236 , may be made of , or comprise aluminum oxide , silicon carbide , magnesia partial stabilized zirconia , yttria tetragonal zirconia polycrystal , porous metal ( e . g ., steel , aluminum , platinum , titanium , and the like ), ceramic coated porous metal , woven metal , spun metal , metal wool ( e . g ., steel wool ), porous polymer , porous coated polymer , porous silica ( i . e ., glass ), and / or porous pyrex . distal wicks 134 , 234 , and proximal wicks 136 , 236 , may be made of or comprise other materials that can absorb a substance to be vaporized . the conductor or heating element that is disposed through proximal wick 136 or 236 may be made of , or comprise , for example : nickel chromium , iron chromium aluminum , stainless steel , gold , platinum , tungsten molybdenum , or a piezoelectric material . the conductor or heating element that is disposed through proximal wick 136 can be made of , or comprise , other materials that become heated when an electrical current is passed through them . fig6 is a perspective view of a light pipe sleeve of a personal vaporizer unit . fig6 is an end view of the light pipe sleeve of fig6 . fig6 is a cross - section of the light pipe sleeve along the cut line shown in fig6 . light pipe sleeve 140 is configured to be disposed within main shell 102 . light pipe sleeve 140 is also configured to hold cartridge 150 and atomizer housing 132 or 232 . as discussed previously , light pipe sleeve 140 is configured to conduct light entering the proximal end of light pipe sleeve 140 ( e . g ., from leds 125 - 127 ) to the distal end of light pipe sleeve 140 . typically , the light exiting the distal end of light pipe sleeve 140 will be visible from the exterior of personal vaporizer 100 . the light exiting the distal end of light pipe sleeve 140 may be diffused by cartridge 150 . the light exiting the distal end of light pipe sleeve 140 may illuminate characters and / or symbols drawn , printed , written , or embossed , etc ., in an end of cartridge 150 . in an embodiment , light exiting light pipe sleeve 140 may illuminate a logo , characters and / or symbols cut through outer main shell 102 . in an embodiment , light pipe sleeve 140 is made of , or comprises , a translucent acrylic plastic . fig6 is a perspective view of a cartridge of a personal vaporizer unit . fig6 is a proximal end view of the cartridge of fig6 . fig6 is a side view of the cartridge of fig6 . fig6 is a top view of the cartridge of fig6 . fig6 is a cross - section of the cartridge along the cut line shown in fig6 . as shown in fig6 - 69 , cartridge 150 comprises a hollow cylinder section with at least one exterior flat surface 158 . the flat surface 158 forms , when cartridge 150 is inserted into the distal end of personal vaporizer unit 100 , an open space between the exterior surface of the cartridge and an interior surface of light pipe sleeve 140 . this space defines a passage for air to be drawn from outside personal vaporizer unit 100 , through personal vaporizer unit 100 to be inhaled by the user along with the vaporized substance . this space also helps define the volume of air drawn into personal vaporizer unit 100 . by defining the volume of air typically drawn into the unit , different mixtures of vaporized substance to air may be produced . the hollow portion of cartridge 150 is configured as a reservoir to hold the substance to be vaporized by personal vaporizer unit 100 . the hollow portion of cartridge 150 holds the substance to be vaporized in direct contact with distal wick 134 or 234 . this allows distal wick 134 or 234 to become saturated with the substance to be vaporized . the area of distal wick 134 or 234 that is in direct contact with the substance to be vaporized may be varied in order to deliver different doses of the substance to be vaporized . for example , cartridges 150 with differing diameter hollow portions may be used to deliver different doses of the substance to be vaporized to the user . cartridge 150 may be configured to confine the substance to be vaporized by a cap or seal ( not shown ) on the proximal end . this cap or seal may be punctured by the end of atomizer housing 132 , or the pointed end 234 - 1 of proximal wick 234 . when inserted into personal vaporizer unit 100 , cartridge standoffs 157 define an air passage between the end of light pipe sleeve 140 and main shell 102 . this air passage allows air to reach the air passage defined by flat surface 158 . the hollow portion of cartridge 150 also includes one or more channels 154 . the end of these channels are exposed to air received via the air passage ( s ) defined by flat surface 158 . these channels allow air to enter the hollow portion of cartridge 150 as the substance contained in cartridge 150 is drawn into a distal wick 134 or 234 . allowing air to enter the hollow portion of cartridge 150 as the substance contained in cartridge 150 is removed prevents a vacuum from forming inside cartridge 150 . this vacuum could prevent the substance contained in cartridge 150 from being absorbed into distal wick 134 or 234 . in an embodiment , cartridge 150 may be at least partly translucent . thus cartridge 150 may act as a light diffuser so that light emitted by one or more of leds 125 - 127 is visible external to personal vaporizer unit 100 . fig7 is a side view of a battery of a personal vaporizer unit . fig7 is an end view of the battery of fig7 . fig7 is a perspective view of a battery support of a personal vaporizer unit . as can be seen in fig7 , battery support 106 does not form a complete cylinder that completely surrounds battery 104 . this missing portion of a cylinder forms a passageway that allows air and the vaporized substance to pass by the battery from the atomizer assembly to the mouthpiece 116 so that it may be inhaled by the user . fig7 is a top perspective view of a personal vaporizer unit case . fig7 is a bottom perspective view of a personal vaporizer unit case . personal vaporizer case 500 is configured to hold one or more personal vaporizer units 100 . personal vaporizer case 500 includes a connector 510 to interface to a computer . this connector allows case 500 to transfer data from personal vaporizer unit 100 to a computer via connecter 510 . case 500 may also transfer data from personal vaporizer unit 100 via a wireless interface . this wireless interface may comprise an infrared ( ir ) transmitter , a bluetooth interface , an 802 . 11 specified interface , and / or communicate with a cellular telephone network . data from a personal vaporizer unit 100 may be associated with an identification number stored by personal vaporizer unit 100 . data from personal vaporizer unit 100 may be transmitted via the wireless interface in association with the identification number . personal vaporizer case 500 includes a battery that may hold charge that is used to recharge a personal vaporizer unit 100 . recharging of personal vaporizer unit 100 may be managed by a charge controller that is part of case 500 . when case 500 is holding a personal vaporizer unit 100 , at least a portion of the personal vaporizer unit 100 is visible from the outside of case 500 to allow a light emitted by personal vaporizer unit 100 to provide a visual indication of a state of personal vaporizer unit 500 . this visual indication is visible outside of case 500 . personal vaporizer unit 100 is activated by a change in impedance between two conductive surfaces . in an embodiment , these two conductive surfaces are part of main shell 102 and mouthpiece 116 . these two conductive surfaces may also be used by case 500 to charge battery 104 . these two conductive surfaces may also be used by case 500 to read data out of personal vaporizer unit 100 . in an embodiment , when a user puts personal vaporizer unit 100 in his / her mouth and provides “ suction ,” air is drawn into personal vaporizer unit 100 though a gap between the end of main shell 102 and cartridge 150 . in an embodiment , this gap is established by standoffs 157 . air travels down galley ( s ) formed by flat surface ( s ) 158 and the inner surface of light pipe sleeve 140 . the air then reaches a “ ring ” shaped galley between atomizer housing 132 , cartridge 150 , and light pipe sleeve 140 . air travels to distal wick 134 via one or more holes 132 - 1 , in chamfered surface ( s ) 132 - 3 . air travels to distal wick 234 via one or more holes 232 - 1 , in chamfered surface ( s ) 232 - 3 . air is also allowed to enter cartridge 150 via one or more channels 154 . this air entering cartridge 150 via channels 154 “ back fills ” for the substance being vaporized which enters distal wick 134 . the substance being vaporized is held in direct contact with distal wick 134 or 234 by cartridge 150 . the substance being vaporized is absorbed by and may saturate distal wick 134 or 234 and proximal wick 136 or 236 . the incoming air drawn through holes 132 - 1 displaces from saturated distal wick 134 the substance being vaporized . the displaced substance being vaporized is pulled from wick elements 134 into a cavity between distal wick 134 and 136 . this cavity may also contain a heating element that has been heated to between 150 - 200 ° c . the displaced substance being vaporized is pulled from wick elements 134 in small ( e . g ., atomized ) droplets . these atomized droplets are vaporized by the heating element . in an embodiment , when a user puts personal vaporizer unit 100 in his / her mouth and provides “ suction ,” air is drawn into personal vaporizer unit 100 though a gap between the end of main shell 102 and cartridge 150 . in an embodiment , this gap is established by standoffs 157 . air travels down galley ( s ) formed by flat surface ( s ) 158 and the inner surface of light pipe sleeve 140 . the air then reaches a “ ring ” shaped galley between atomizer housing 232 , cartridge 150 , and light pipe sleeve 140 . air travels to proximal wick 234 via one or more holes 232 - 1 , in chamfered surface ( s ) 232 - 1 . air is also allowed to enter cartridge 150 via one or more channels 154 . this air entering cartridge 150 via channels 154 “ back fills ” for the substance being vaporized which enters proximal wick 234 . the substance being vaporized is held in direct contact with proximal wick 234 by cartridge 150 . the substance being vaporized is absorbed by and may saturate distal wick 243 and proximal wick 236 . the incoming air drawn through holes 232 - 1 displaces from saturated proximal wick 234 the substance being vaporized . the displaced substance being vaporized is pulled from wick elements 234 into a cavity between wick distal wick 234 and proximal wick 236 . this cavity may also contain a heating element that has been heated to between 150 - 200 ° c . the displaced substance being vaporized is pulled from distal wick 234 in small ( e . g ., atomized ) droplets . these atomized droplets are vaporized by the heating element . in both of the previous two embodiments , the vaporized substance and air are drawn down a galley adjacent to battery 104 , through mouthpiece insulator 112 , mouthpiece 116 , and mouthpiece cover 114 . after exiting personal vaporizer unit 100 , the vapors may be inhaled by a user . the systems , controller , and functions described above may be implemented with or executed by one or more computer systems . the methods described above may be stored on a computer readable medium . personal vaporizer unit 100 and case 500 may be , comprise , or include computers systems . fig7 illustrates a block diagram of a computer system . computer system 600 includes communication interface 620 , processing system 630 , storage system 640 , and user interface 660 . processing system 630 is operatively coupled to storage system 640 . storage system 640 stores software 650 and data 670 . processing system 630 is operatively coupled to communication interface 620 and user interface 660 . computer system 600 may comprise a programmed general - purpose computer . computer system 600 may include a microprocessor . computer system 600 may comprise programmable or special purpose circuitry . computer system 600 may be distributed among multiple devices , processors , storage , and / or interfaces that together comprise elements 620 - 670 . communication interface 620 may comprise a network interface , modem , port , bus , link , transceiver , or other communication device . communication interface 620 may be distributed among multiple communication devices . processing system 630 may comprise a microprocessor , microcontroller , logic circuit , or other processing device . processing system 630 may be distributed among multiple processing devices . user interface 660 may comprise a keyboard , mouse , voice recognition interface , microphone and speakers , graphical display , touch screen , or other type of user interface device . user interface 660 may be distributed among multiple interface devices . storage system 640 may comprise a disk , tape , integrated circuit , ram , rom , network storage , server , or other memory function . storage system 640 may be a computer readable medium . storage system 640 may be distributed among multiple memory devices . processing system 630 retrieves and executes software 650 from storage system 640 . processing system may retrieve and store data 670 . processing system may also retrieve and store data via communication interface 620 . processing system 650 may create or modify software 650 or data 670 to achieve a tangible result . processing system may control communication interface 620 or user interface 670 to achieve a tangible result . processing system may retrieve and execute remotely stored software via communication interface 620 . software 650 and remotely stored software may comprise an operating system , utilities , drivers , networking software , and other software typically executed by a computer system . software 650 may comprise an application program , applet , firmware , or other form of machine - readable processing instructions typically executed by a computer system . when executed by processing system 630 , software 650 or remotely stored software may direct computer system 600 to operate as described herein . the above description and associated figures teach the best mode of the invention . the following claims specify the scope of the invention . note that some aspects of the best mode may not fall within the scope of the invention as specified by the claims . those skilled in the art will appreciate that the features described above can be combined in various ways to form multiple variations of the invention . as a result , the invention is not limited to the specific embodiments described above , but only by the following claims and their equivalents .

US-78087710-A

the present invention provides piperine and analogues or derivatives thereof for the treatment of skin conditions treatable by stimulation of melanocyte proliferation , such as vitiligo , and also for treating skin cancer . the piperine and analogues or derivatives thereof may also be used to cosmetically promote or enhance the natural coloration of the skin .

one useful class of compounds of formula ( 1 ) is that in which ( a ) n is 0 , p and q are each 0 or 1 , m is 2 , the r 1 s together represent a 3 ′, 4 ′- methylenedioxy group , r 3 and r 4 , together with the carbon atoms to which they are attached form a carbon to carbon double bond and , when p and q are each 0 or 1 , r 5 and r 6 and r 7 and r 8 together with the carbon atoms to which they are attached , form a carbon to carbon double bond and r 9 is piperidino , or ( b ) n is 0 , one of p or q is 1 and ( i ) m is 3 , the r 1 s being 3 ′, 4 ′- methylenedioxy and 6 ′- methoxy or ( ii ) m is 2 , the r 1 s being 3 ′- hydroxy - 4 ′- methoxy ; or ( iii ) m is 1 and the r 1 is 4 ′- hydroxy ; and r 3 to r 9 are as defined in case ( a ) above , or ( c ) n is 0 , one of p and q is 1 , r 9 is piperidino , pyrrolidino , isobutylamino or methoxy and all other symbols are as defined in case ( a ) above , or ( d ) n is 0 , one of p and q is 1 , r 5 , r 6 , r 7 and r 8 represent hydrogen atoms and either r 3 and r 4 also do or r 3 and r 4 together with the carbon atoms to which they are attached form a carbon to carbon double bond ; and m , r 1 and r 9 are as defined in case ( a ) above ; ( e ) n is 0 , p = q = 1 and r 3 , r 4 , r 5 , r 6 , r 7 and r 8 represent hydrogen ; ( f ) n is 0 , one of p and q is 1 , r 3 , r 4 , r 5 , r 6 , r 7 and rs represent hydrogen and r 9 is cyclohexylamino ; and in all of which cases ( a ) to ( f ) the molecule is in the e , e or all e geometric configuration or in case ( a ) when n is 1 may be in the z , z , z , e or e , z geometric configuration . the following are preferred features of the compounds of formula ( 1 ) considered alone or in any possible combination of two or more : n is 0 , one of p and q is 1 , r 3 and r 4 together and one of r 5 and r 6 together or r 7 and r 8 together represent double bonds or r 3 , r 4 , r 5 , r 6 , r 7 and r 8 all represent hydrogen atoms m is 2 or 3 , two r 1 s represent 3 ′, 4 ′- methylenedioxy and optionally a third r 1 , representing 6 ′- methoxy , is also present r 9 represents a piperidino , 4 - methylpiperidino , pyrrolidino or morpholino group or an alkylamino group having 4 to 6 atoms , preferably branched chain and especially an isobutylamino ( 2 - methylpropylamino ) group , a cycloalkyl amino group of 4 to 7 carbon atoms , especially a cyclohexylamino group , or a 3 , 4 - methylenedioxy - substituted benzylamino or 2 - phenethylamino group alternatively r 9 is an alkoxy group having from 1 to 6 carbon atoms , preferably 3 to 6 the geometric configuration at the double bonds is as in piperine ( all e , e ) while the preferred meaning of r 1 is a 3 ′, 4 ′- methylenedioxy group , r 1 may alternatively be provided by one , two or even three groups selected from hydroxy and alkoxy of 1 to 3 carbon atoms , preferably methoxy , e . g . as in 3 ′- methoxy , 4 ′- methoxy , 6 ′- methoxy and 3 ′, 4 ′- dimethoxy substitution of the left - hand benzene ring . the twice - daily topical application of compounds of formula ( 1 ) has been found to induce significant pigmentation in mice . skin coloration in the mouse population under study was first observed at approximately four weeks after the treatment was started . this coloration was enhanced further as a result of subsequent topical applications . specific preferred compounds for use in the invention are as follows : variations and alterations ( all other structural features of the molecule are as in piperine unless otherwise indicated ) compounds of formula ( 1 ) and trivial names variation in stereochemistry at double bonds and in extent of conjugation in chain 1 ( e , e ) - piperine 2 ( z , z ) - chavicine 3 ( z , e ) - isopiperine 4 ( e , z ) - isochavicine 5 3 , 4 - dihydropiperine - piperanine 6 1 , 2 , 3 , 4 - tetrahydropiperine variation in separation of rings ( conjugated ) structures ( all e ) 7 n = 0 - ilepcimide 1 n = 1 - piperine 8 n = 2 - piperettine alterations to nitrogen substituent structures ( all e , e ) r 6 = 1 piperidino - piperine 9 pyrrolidino - trichostachine 10 isobutylamino - piperlonguminine 11 methoxy - despiperidylmethoxypiperine 17 morpholino 18 hexylamino 19 3 ′, 4 ′- methylenedioxybenzylamino alterations to the phenyl substituent 1 3 ′, 4 ′- methylenedioxyphenyl ; n = 1 - piperine 12 as 1 + 6 ′- methoxy ; n = 1 ; - wisanine 13 3 ′- hydroxy , 4 ′- methoxyphenyl ; n = 1 - 4 ′- methoxyisocoumaperine 14 4 ′- hydroxyphenyl ; n = 1 - coumaperine 20 4 ′- methoxyphenyl ; n = 0 alterations to connecting chain and amide group the naturally occurring compounds ( including piperine ) can be extracted from suitable plant sources or synthesised using methods known to a skilled person ( see , for example , chapman and hall , combined chemical dictionary on cd - rom , release 1 : 1 ( 1997 ) and the merck index ( 1983 ), 10th edition . publ . merck and co , rahway , usa . pp . 1077 - 1078 ( except compounds 2 and 3 )). many of the above , occur in p . nigrum or other piper species ( 10 and 12 ). compounds 2 and 3 can be prepared by isolation from p . nigrum using methods known to a skilled person ( see , for example , cleyn r de and verzele m ( 1975 ). constituents of - peppers . part vii . spectroscopic structure elucidation of piperine and its isomers . bulletin de la societe chimique belgique , 84 , 435 - 438 ). compound 6 can be prepared by hydrogenation of piperine , using known methods . compound 11 can be prepared by methanolysis of piperine using sodium methoxide . compound 13 can be prepared from 3 - hydroxy - 4 - methoxybenzaldehyde using methods analogous to those used for the preparation of piperine . other compounds within formula ( 1 ) can be prepared from the appropriate acid with the appropriate connecting chain between the carboxylic acid function and the benzene ring and having the appropriate stereochemistry . where necessary , this may be preceded or followed by reduction to reduce the double bond or bonds in the connecting chain . methods of preparing amides and esters from these acids are illustrated by the examples below . they may also be adapted from the references cited herein , the disclosure of which is herein incorporated by reference . the active compounds may be formulated for topical use in the form of creams , soft paraffin or lotions . aqueous cream bp or yellow soft paraffin bp may suitably contain the active at 0 . 03 - 3 . 0 mg % w / w or an equivalent amount of plant extract . a suitable lotion is typically prepared from 20 % glycerol and 80 % ethanol in purified water and contains 0 . 03 - 3 . 0 mg % w / w of the active material . these topical formulations may also contain penetration enhancers such as oleic acid , propylene glycol , ethanol , urea , lauric diethanolamide or azone , dimethyl sulphoxide , decylmethyl sulphoxide , or pyrrolidone derivatives . liposomal delivery systems may also be used . compositions for oral formulation include tablets or capsules containing 1 . 5 - 150 mg active or equivalent amount of plant extract . the invention will now be described with reference to the following non - limiting examples , with reference to the accompanying tables and drawings . [ 0066 ] piper nigrum l . fruit ( black pepper , piperaceae ), originally from india , was purchased from the food centre , 70 turnpike lane , london n8 , uk . the rest of the herbs were either supplied by east - west herbs , kingham , oxon , uk or by cipla ltd , mumbai , india . for the preliminary screening programme , the powdered dry herb ( 10 g ) was heated to boiling in distilled water ( 100 ml ) and allowed to boil for 10 min , using a hot plate as heat source . the plant material was filtered off under vacuum through filter paper ( whatman ), and the filtrate freeze - dried . cells of mouse melan - a cell line ( passage number 18 - 24 ), a first known line of non - tumorigenic pigmented mouse melanocytes were maintained in a flask ( costar , cambridge , mass ., usa ) using rpmi 1640 ( icn , costa , mesa , calif ., usa ) as a basic medium . for microplate proliferation assays , subconfluent melan - a cultures were trypsinized ( 0 . 25 % trypsin at 37 ° c . for 5 - 10 min ) and inoculated with a repeater - pipettor ( finn pipette , labsystems , finland ) into 96 - well microtiter plates ( costar , cambridge , mass ., usa ). the plates were incubated at 37 ° c . in a 10 % co 2 , 90 % air humidified atmosphere for the stated length of time . at the end of the incubation , an srb assay was performed . briefly , cells attached to the bottom of the plate were fixed by addition of cold trichloroacetic acid ( tca , 4 ° c ., aldrich , dorset , uk ) on the top of the growth medium ( final tca 20 % w / v ). the plate was placed at 4 ° c . for 1 hour before being gently washed five times with tap water . it was allowed to dry in air , or aided with a hair dryer to speed up the drying process , then 50 μl of 4 % w / v srb dissolved in 1 % acetic acid in water was added to each well for 30 min . at the end of the staining period , unbound srb was removed by washing 4 times with 1 % acetic acid . the plate was air dried again , and 150 μl of 10 mm aqueous tris base ( sigma - aldrich co . ltd , irvine , uk ) was added into each well to solubilize the cell - bound dye . the plate was shaken for 15 min on a gyratory shaker followed by reading the optical density ( od ) at 550 nm in a microplate spectrophotometer ( anthos labtec ht3 , version 1 . 06 ) prior to testing the herbal extracts , optimal culture conditions were established . the variable factors regarding incubation conditions include foetal bovine serum ( fbs ) concentration , initial cell seeding density and incubation period . to determine optimum fbs concentration , 1 , 2 , and 5 % fbs were used to culture the melan - a cell line , the growth pattern with each concentration of fbs was monitored by srb assay . for the determination of optimum cell seeding density , a series of initial seeding density of 0 . 15 to 1 . 2 × 10 4 cell per well of melan - a cells were plated into 96 - well plates with 5 % fbs and 20 nm tetradecanoyl phorbol acetate ( tpa ) supplemented growth medium . the growth pattern was monitored with srb assay at daily intervals . the culture was extended to 8 days ; on day 4 , the medium in the remaining plates was replaced . the optimal condition for the negative experimental control , is that cells neither grow too fast nor decline dramatically . rapid growth might mask any subtle stimulatory effect brought about by the herbal extracts , whereas a dramatic decline in cell numbers indicates unfavourable culture conditions for cell survival , which could lead to cell damage . fig1 shows the growth curves of melan - a cell line at three different concentrations of fbs . neither 1 % nor 2 % fbs supplemented medium was able to maintain cell survival ; cell numbers declined significantly in 4 days of culture . however , 5 % fbs was capable of keeping melan - a cell line alive with only a small increase in cell numbers observed over 4 days . tpa ( 20 nm ) was able to cause further proliferation in the presence of 5 % fbs indicating that cells were capable of responding to mitogenic stimuli at 5 % fbs . morphological observations under a microscope revealed that with 1 % and 2 % fbs supplemented medium , cell bodies were round , lightly pigmented with few dendritic processes and the culture displayed an ageing growth pattern . however in 5 % fbs , cells possessed more melanosomes and some short dendrites without an ageing appearance . therefore 5 % fbs was used throughout in the herbal screening experiments . in fig2 growth curves over 8 days with different initial cell numbers were plotted to elucidate the melan - a cell line &# 39 ; s growth pattern in 96 - well plates in the presence of 5 % fbs and 20 nm tpa . the optimal initial plating density together with proper harvesting time was determined . all of the initial plating number of cells showed a net growth in the presence of tpa and 5 % fbs supplemented medium , although the higher plating density of 1 . 2 × 10 4 cells / well depleted the growth medium on day 3 of culture and the cells ceased to grow until the medium was replaced . with the lower plating densities ( 2 - 4 × 10 3 cells / well ) the srb assay od readings remained relatively low after 8 days &# 39 ; culture . the initial plating density of 6 × 10 3 cells / well exhibited exponential growth , and after 4 days of culture , the od reading increased to a value of about 0 . 4 . since the higher od values are associated with greater precision and accuracy , it was determined that the initial inoculation of 6 × 10 3 cells / well was the optimum density for the herbal test experiment . for the simplicity of the experiment , harvesting time was day 4 since the cells at this stage was not confluent and after 4 days , growth medium tended to become depleted and replacement was necessary for the further growth . melan - a cells were seeded at a density of 6 × 10 3 / 100 μl / well in standard medium supplemented with 0 nm tpa and 5 % fbs . after 4 hours of incubation , herbal extracts , which were reconstituted in growth medium and sterilised by filtration ( pore size 0 . 2 μm ), of different concentrations was added into each well . final concentrations of plant extract were 0 ( negative control ), 10 , 100 and 1000 μg dry extract per ml . 6 replicate wells were used for each concentration tested . the negative control ( 12 wells ), positive control ( 20 nm tpa , 6 wells ), and test wells were all in the same 96 - well plate . the culture was terminated after 4 days and srb assay performed according to the methods given above . the effect of 30 herbal extracts on the proliferation of melan - a cell line table 1 shows the results of the preliminary screening of 30 aqueous herbal extracts on the proliferation of melan - a cell line . crude extracts of astragalits membranaceous ( fisch .) bunge , unripe citrus reticulata blanco , dictamnus dasycarpus turcz ., ophiopogon japonicus ( thunb .) kergawe , piper nigrum l ., poria cocos ( schw .) wolf and tribulus terestris l . were observed to stimulate melanocyte proliferation , sometimes even at the lowest dose level of 10 μg / ml . other extracts either had no significant effect or were cytotoxic . among these positive responses , that of piper nigrum l . extract at 0 . 01 and 0 . 1 mg / ml was the most pronounced . piper nigrum extract at these two concentrations not only strikingly enhanced cell growth , but this extract also altered the cell morphology . in the presence of piper nigrum extract , the cellular bodies were smaller , with more and longer bipolar or polydendritic processes , an effect similar to that observed with tpa . repeats of the tests on piper nigrum extract on the melan - a cells a newly prepared piper nigrum fruit extract was tested on a new batch of melan - a cell line with the culture in microplates extended to 8 days . the effects of piper nigrum extract on the growth of melan - a cell line were evaluated by srb assay . repeats of the tests of piper nigrum extract on melan - a cells in the light of the positive results from the preliminary experiment , further investigations on piper nigrum extract were carried out . fig3 shows that the result of the significant proliferant effect brought about by the piper nigrum extract was even more marked on the extension of the incubation period to 8 days of culture , the growth was 272 % of the control ( cells only ). microscopically , the morphology of the cells was altered as those seen in the preliminary experiments . confirmation of the proliferant effect of piper nierum by haemocytometer counting melan - a cells were plated in petri dishes ( 035 mm , nunclon , denmark ) with a plating density of 2 × 10 4 / ml and piper nigrum extract at concentrations of 0 . 01 and 0 . 1 mg / ml . a negative control ( cells in medium only ) and positive tpa ( 20 nm ) control were also set up . after 4 days the cells in each dish were harvested and counted with haemocytometer . confirmation of the proliferant effect of piper nigrum by haemocytometer counting srb assay indirectly estimates cell number through protein staining and spectrophotometric measurement . to confirm if piper nignim extract stimulates melan - a cell proliferation , a direct cell counting with haemocytometer method was employed . table 2 shows the cell numbers in the presence of piper nigrum extract and 20 nm tpa . cell number under the influence of piper nigrum extract at 0 . 01 and 0 . 1 mg / ml were increased significantly compared to control , but less than that with 20 nm tpa . this result is consistent with the finding in 96 - well microplate srb assay . piperine ( sigma - aldrich co . ltd , irvine , uk ) was dissolved in meoh , sterilised by filtration through a membrane ( pore size 0 . 2 μm ) and diluted with standard growth medium . the final concentrations in culture were 0 . 1 and 1 μm . a separate experiment ( data not shown ) showed that the concentration of meoh present in these experiments was not toxic or proliferant to the cells . the effect of this compound on melan - a cell line is shown in fig4 . piperine at the two concentrations tested significantly stimulated melan - a proliferation . this compound brought about morphologic changes to melan - a cells , with smaller cell bodies , more and longer cellular dendrites , resembling those alterations induced by piper nigrum extract and tpa . this indicates that piperine is an active principle responsible for the observed proliferant effect of piper nigrum . test of piperine on different cell types to determine its specificity in order to determine the specificity of piperine , a panel of different cell types were employed to facilitate this investigation . these included melan - a , melan - c , svk14 , csm , xb2 , sc1 , b16f10 , im9 , caco2 , swiss 3t3 cell lines and normal human lymphocytes . tpa ( 20 nm ) was also tested on these cells . table 3 shows the biological origin of the cells and an outline of the cell culture protocols . the effects of piperine and tpa on the growth of a panel of cell types . from table 4 , it can be seen that piperine has a highly selective effect on the growth of a panel of cell types , since it only stimulates the mouse melanocytes ( melan - a , melan - c ), human melanoblasts ( fm21e ), human foetal melanocytes ( fm 21e ) and the mouse fibroblast sc1 cell lines at the concentration tested . the sc1 cell line may have a particular sensitivity to tpa due to the way in which it has been derived , i . e . it has been cultured in the presence of tpa . however , piperine has either no effect or a cytotoxic effect on other cells . this result implies that piperine may have desirable specificity index for the proliferation of melanocytes in culture and is not a general mitogen . in our experimental system , tpa , a well known pkc activator and a tumour promoting agent , had similar effects to piperine on all cell types tested , except that tpa strikingly stimulated human lymphocyte and 3t3 fibroblast proliferation whereas piperine obviously lacked such an activity . piperine seems to be a less potent stimulant than tpa . mode of action : effect of ro - 31 - 8220 on the growth of melan - a cells with piperine and tpa melan - a cell line cultured with piperine 1 μm and tpa 20 nm separately was set up in a 96 - well plate , 1 μl of different concentrations of ro - 31 - 8220 ( calbiochem - novabiochem ) in dmso was introduced with a micro - syringe into the wells to make up the final ro - 31 - 8220 concentrations of 0 ( control ), 0 . 1 , 1 , 5 , 10 , 100 nm , with final dmso concentrations smaller than 0 . 01 % v / v , at which the dmso showed neither toxic nor proliferant effect to the cells in a separate experiment ( data not shown ). 6 replicate wells were used for each concentration . the culture was incubated for 4 days before it was terminated and processed with srb assay to evaluate the growth of melan - a cells . mode of action : effect of ro - 31 - 8220 on the growth of melan - a cells with piperine and tpa [ 0107 ] fig5 shows the effect of ro - 31 - 8220 on the survival and growth of melan - a cell line in the presence or absence of piperine and tpa . ro - 31 - 8220 alone did not have significant cytotoxic effect to the cells at the concentrations up to 100 nm . however , the proliferant effects of piperine , and tpa ( as indicated by the y axis values ) on melan - a cells were effectively inhibited by the presence of ro - 31 - 8220 at the concentrations of 0 . 1 - 100 nm . it thus appears that piperine and tpa exert their proliferant effects through the activation of pkc cell signalling pathway . the selectivity of piperine on the growth of a panel of cell types has also been tested . it was found that piperine possessed a fairly high specificity and selectivity towards melanocytes , since it significantly stimulated the growth of melan - a , melan - c and fm21e melanoblasts and fm21e melanocytes in culture , whereas it did not stimulate all other cells apart from a tpa - sensitive fibroblast cell line . piperine was observed to have inhibitory effects on b16 mouse melanoma cell line which is syngeneic with melan - a cells . thus piperine may be a specific stimulant for the proliferation of melanocytes in vitiliginous skin without the risk of stimulating melanoma cells . human melanoblasts in culture in this experiment were established from human foetal skin . subconfluent melanoblasts maintained in mcdb 153 medium supplemented with 10 % fbs , 10 ng / ml stem cell factor ( scf ) and 1 mm endothelin 3 were subcultured and inoculated into 96 - well microplate with 6 × 10 3 cells / 100 μl / well . after incubation in the 10 % co 2 , humidified atmosphere , at 37 ° c . for 3 - 4 hours to allow the attachment of the cells on the plate , piperine dissolved in meoh and water was added into the wells . the final concentrations of piperine were 1 , 5 , 10 , 100 μm , with tpa ( 20 nm ) as positive control . six replicates were used in each group of treatment , with 12 wells used for vehicle control . the incubation was conducted for 5 days before cells were harvested by fixing with cold trichloroacetic acid ( tca , at 4 ° c ., final concentration 20 % v / v ), and evaluated for cell number using an srb assay . one way anova and dunnett &# 39 ; s t - test was employed to test the significance of any differences between treatment groups and vehicle control . growth in the presence of piperine and tpa was expressed as % of control incubations containing no piperine or tpa . the experiments were repeated using melanoblasts from 3 different donors . [ 0112 ] fig6 shows the effect of piperine on the growth of human melanoblasts in vitro . piperine at the concentrations of 1 , 10 , 100 μm was found to cause significant stimulation to human melanoblasts in a dose response manner , with 34 % more cell yield compared to vehicle control when the culture was exposed to 100 μm piperine in culture for 5 days . tpa , a well - known melanocytic growth - stimulating agent , was also able to cause significant cell growth at tested concentrations , with over 50 % of more cell yield observed when the culture was exposed to 20 nm for 5 days . in the other repeated experiments , piperine was consistently observed to induce significant cell growth at the concentrations ranging from 5 - 100 μm ; these stimulatory effects were generally less than that of tpa . morphologically , in the presence of piperine , melanoblasts appeared to be more dendritic and the cell bodies were flatter and smaller . human melanocytes used in this experiment were derived from induced differentiation of human foetal melanoblasts . the key character of human melanocytes that is different from its precursor melanoblasts is their ability to synthesise melanin . melanin is a valid marker for melanocytes . the cell pellet of human melanocytes exhibits a characteristic brown to black colour , whereas human melanoblasts cannot produce melanin thus devoid of brown or black colour in the cell pellet . two protocols were employed for the experiments on human melanocytes in culture . the first employed 24 - well plates and evaluated cell number with srb assay . the second employed petri dishes and cell number was counted with a haemocytometer chamber . for the first protocol , subconfluent human melanocytes maintained in a ø100 mm petri dish were subcultured into two 24 - well plates ( falcon ) using basic culture medium of rpmi 1640 supplemented with fbs ( 10 %), bfgf ( 100 pm ), ct ( 1 nm ) and endothelin 1 ( 1 nm ). the initial plating density was 20 , 000 cells / cm 2 ( 38 , 200 cells / well ) with each well containing 1000 μl medium . after incubation in a 10 % co 2 , humidified atmosphere , at 37 ° c . for 2 - 3 hours to allow the attachment of the cells , piperine in 500 μl medium was added into wells to made up final concentrations of 0 , 1 , 5 , 10 and 100 μm . cells only in the medium with above supplement lacking of endothelin 1 were also set up as negative control . six replicates were used in each group of treatment , and culture was incubated for 5 days before the cells were harvested by fixing with cold tca ( final concentration 20 %) and processed with srb assay . the solubilized srb dye solution was transferred to a 96 - well plate for optical density reading . for the second protocol , subconfluent human melanocytes were subcultured in a 060 mm petri dishes ( 28 cm 2 , falcon ) with rpmi 1640 basic medium supplemented with fbs ( 10 %), ct ( 1 nm ), bfgf ( 100 pm ) and endothelin 1 ( 1 nm ). the initial plating density was 10 , 000 cells / cm 2 , with 5 ml medium per dish . cells were incubated for 2 - 3 hours in 10 % co 2 , humidified atmosphere , at 37 ° c ., followed by addition of piperine solution in to the dishes , making the final concentrations of 0 , 1 , 5 , 10 and 100 μm . cells in the above supplemented medium lacking endothelin 1 were also set up as a negative control . three dishes were used for each treatment and the culture was maintained for 5 days before cells were harvested with trypsinisation and counted with a haemocytometer chamber . for melanin production experiment , the harvested cells were centrifuged and pelleted . after carefully removing the medium , naoh ( 1 m ) was used to solubilized the cell pellets and optical density read at 475 nm in a perkin - elmer wv spectrophotometer ( model uv / vis lambda 2 ). the melanin content was calculated by using a regression equation y = 0 . 005 + 0 . 005x corresponding to the calibration curve for synthetic melanin . [ 0119 ] fig7 delineates the effects of piperine on the growth of human melanocytes cultured in 24 - well plate . piperine at the concentrations of 5 and 10 μm markedly stimulates the growth of these pigmented cells , with 36 % more cells yielded when the culture was under the influence of 10 μm piperine for 5 days . however , at 100 μm , piperine exerted inhibitory effect on the growth of these cells . in addition , in the presence of 1 nm endothelin 1 , tpa at 20 nm was not able to stimulate cell growth in our culture system , a result that is of great difference with that observed in human melanoblasts . table 5 shows the effects of piperine on the growth of human melanocytes cultured in petri dishes . it is conspicuous that in the presence of et1 ( 1 nm ), piperine at the concentrations of 5 and 10 μm significantly stimulated the growth of human melanocytes , with cell number over twice as many as that of et1 ( 1 nm ) control when this melanocyte cell type was exposed to 5 wm piperine for 5 days . this result was consistent with that obtained from the 24 - well plate experiments , and it served to confirm that the stimulatory effects observed by srb assay were indeed due to increased cell number rather than augmentation of protein production alone . tables table 1 . preliminary screening of 30 herbal aqueous extracts on the proliferation of melan - a cell line detected with srb assay after 4 days culture . cell number (% of control ) after 4 days incubation when grown in the presence of extract at : names of herbs plant part 1 mg ml − 1 0 . 1 mg ml − 1 0 . 01 mg ml − 1 plants with a significant stiinulatory effect astragalus membranaceous ( fisch .) bunge root 163 . 2 * 123 . 6 * 105 . 6 citrus reticulata blanco ( qing pi - unripe ) peel 16 . 0 138 . 5 * 127 . 6 * dictamnus dasycarpus turcz . root bark 105 . 0 159 . 4 * 98 . 0 ophiopogon japonicus ( thunb .) kergawe root 127 . 8 * 126 . 5 * 108 . 4 piper nigrum l . fruit 11 . 5 215 . 4 * 151 . 3 * poria cocos ( schw .) wolf ( fungus ) sclerotium 79 . 0 134 . 6 * 128 . 8 * tribulus terrestris l . fruit 80 . 7 136 . 1 * 142 . 2 * plants with no significant stimulatory effect angelica daliurica ( fisch .) benth . & amp ; hook . root 50 . 4 118 . 3 107 . 0 chaenomeles lagenaria ( loisel .) koldz . fruit 57 . 1 74 . 5 99 . 0 citrus reticulata blanco ( chen pi - ripe ) peel 34 . 6 101 . 1 81 . 1 corydalis bulbosa d . c . root 91 . 8 101 . 2 92 . 9 curcuma longa l . root 84 . 1 104 . 8 108 . 3 cyperus rotundus l . rhizome 27 . 5 52 . 8 55 . 8 cornus officinalis sieb . et zucc . fruit 30 . 4 92 . 1 101 . 6 gentiana scabra bunge root 42 . 2 107 . 4 108 . 6 ligustrum lucidum ait . fruit 97 . 6 58 . 1 98 . 4 lithospermutn erythrorhizon sieb . et zucc . root 43 . 8 103 . 8 111 . 3 notopteygium incisium ting root / rhizome 18 . 1 97 . 4 94 . 8 paeonia lactiflora pall . root 31 . 8 62 . 2 100 . 7 paeonia suffruticosa andr . root 53 . 2 72 . 0 132 . 8 picrorhiza kurroa royle ex . benth rhizome 42 . 5 77 . 5 90 . 0 platycodon grandiflorum ( jacq .) a . dc . root 35 . 1 94 . 1 96 . 8 plumbago zeylanica l . root 30 . 2 103 . 9 114 . 1 polygala tenuifolia willd . root 12 . 7 43 . 7 79 . 6 ramulus mari ( insect ) whole 41 . 1 87 . 1 89 . 4 siesgesbeckia pubescens makirio herb 17 . 0 40 . 8 51 . 7 spirodela polyrrhiza ( l .) scheid herb 100 79 . 3 96 . 6 trichosanthes kirilowii maxim root 112 . 9 108 . 1 116 . 1 tripterygium wilfordii hook . root 89 . 8 36 . 7 63 . 3 zingiber officinale roscoe rhizome 7 . 9 105 . 8 90 . 6 [ 0121 ] table 2 effects of piper nigrum extract on the proliferation of melan - a cells counted with haemocytometer treatment to cells cell number (× 10 − 4 / ml ) control 2 . 02 20 nm tpa 5 . 0 * piper nigrum at 0 . 01 mg / ml 3 . 06 * piper nigrum at 0 . 1 mg / ml 3 . 13 * [ 0122 ] table 3 biological origin and the culture conditions of a panel of different cell types used in selectivily experiment . optimum culture conditions cell name biological origin fbs medium incubation ( 4 days ) melan - a normal epidermal melanoblasts from embryos of inbred 5 % rpmi1640 37 ° c ., 10 % co 2 c57bl mice melan - c albino embryos of outbred lac - mf strain mice 10 % rpmi1640 37 ° c ., 10 % co 2 fm2le human foetal melanoblasts from epidermis ( strain 21 ) 10 % mcdb153 37 ° c ., 10 % co 2 melanoblast fm21e human melanocytes derived from fm2le melanoblasts rpmi1640 37 ° c ., 10 % co 2 melanocyte svk14 human keratinocytes 10 % dmem 37 ° c ., 10 % co 2 csm14 . 1 . 4 neuronal cells from mesencephalin of rat 10 % dmem 34 ° c ., 5 % co 2 sd fibroblastoids from neonatal murine skin 10 % dmem 37 ° c ., 10 % co 2 xb2 murine keratinocytes 10 % dmem 37 ° c ., 10 % co 2 b6f10 mouse melanoma 5 % rpmi1640 37 ° c ., 10 % co 2 cac02 human colon cancer 10 % rpmi1640 37 ° c ., 10 % co 2 im9 human lymphoblastoid b cells 10 % rpmi1640 37 ° c ., 5 % co 2 swiss 3t3 mouse flbroblasls 10 % dmdm 37 ° c ., 5 % co 2 human healthy human blood samples 10 % dmem 37 ° c ., 5 % co 2 lymphocytes [ 0123 ] table 4 effects of piperine and tpa on the growth of a panel of cell types . ( see table 3 for details of cells ) cell number as a % of control tpa at the piperine at the concentration of ( μm ) concentration of cell type 0 . 01 0 . 1 1 10 100 20 nm 200 nm melan - a nd 130 * 169 * 153 * nd 295 * nd melan - c 109 208 * 198 * 119 * ‘ 137 * 186 * 222 * fm21e melanoblast nd 101 101 119 * 134 * 153 * nd fm21e human melanocytes nd nd 98 143 * 75 * 98 102 svk14 97 101 92 84 * 23 * 71 * 66 * csm14 . 1 . 4 93 94 95 89 64 * 85 * 76 * sc1 191 * 178 * 175 * 204 * 190 * 178 * 199 * xb2 80 90 86 90 42 * 96 99 b16f10 71 * 64 * 47 * 33 * 0 * 35 * 55 * caco2 103 99 102 81 * 34 * 95 90 im9 nd 101 103 69 * nd nd nd swiss 3t3 113 104 106 102 51 * 185 * 207 * human lymphocytes nd 93 93 nd nd 282 * nd [ 0124 ] table 5 effects of piperine on the proliferation and melanin production of human melanocytes cultured in petri dishes cell no . (× 10 − 4 ) ± sd after cultured for 5 % of control od reading ± sd melanin treatments days ( et1 1 nm ) at 475 nm content / 10 4 cells cells only 17 . 71 ± 6 . 16 * 49 . 1 0 . 026 ± 0 . 0049 * 0 . 23 ± 0 . 001 μg et1 ( 1 nm ) 36 . 04 ± 6 . 16 100 . 0 0 . 087 ± 0 . 044 0 . 46 ± 0 . 01 μg et1 ( 1 nm ) + 60 . 83 ± 16 . 78 168 . 8 0 . 134 ± 0 . 014 * 0 . 42 ± 0 . 03 μg piperine ( 1 μm ) et1 ( 1 nm ) + 78 . 96 ± 5 . 63 * 219 . 1 0 . 137 ± 0 . 0085 * 0 . 334 ± 0 . 01 μg piperine ( 5 μm ) et1 ( 1 nm ) + 64 . 79 ± 13 . 47 * 179 . 8 0 . 139 ± 0 . 028 * 0 . 41 ± 0 . 07 μg piperine ( 10 μm ) et1 ( 1 nm ) + 61 . 04 ± 10 . 04 169 . 4 0 . 144 ± 0 . 0046 * 0 . 46 ± 0 . 001 μg piperine ( 100 μm ) vitiligo is defined as a circumscribed , acquired , idiopathic , progressive hypomelanotic skin disorder which is characterised by the development of patchy depigmented macules due to progressive loss of melanocytes which is often familial with lack of established aetiology . various piperine derivatives of formula ( 1 ) were synthesised and tested for melanocyte ( mouse melan - a ) proliferant activity in - vitro . cells were incubated with the text compound for 4 days , after which the sulphorhodamine - b ( srb ) assay was performed to determine cell number srb uptake was measured as optical density at 550 nm . the control assay was carried out on cells incubated without test compound . there were 2 or 3 series of experiments , each of which consisted of six replicate experiments . the results are tabulated below . percentage cell growth was obtained with a given compound calculated as ( optical density in the presence of the compound / control optical density )× 100 . melan - a cell proliferant activity for tested compounds was compared with that obtained with piperine . percentage stimulant activity is ( a - 100 ) where a stands for piperine or a test compound &# 39 ; s percentage cell growth ( see 1 . 1 ). all figures are given with standard error of measurement . effect on dendricity of melan - a cells by the test compounds was by observation under microscope . dendricity is relevant to vitiligo since normal skin melanocytes have dendrites , but in vitiligo the melanocytes seem to lose these before they disappear from the patches . analogues of piperine were synthesised using methods described in the literature , adapted from the literature or devised in the inventors &# 39 ; laboratory . structures of compounds were verified using nmr , ms , ir spectroscopy and melting point . unless a synthetic method is given , reagents and reactants were purchased from sigma aldrich . table 6 presents an overall summary of the results appearing in detail in other tables which follow . tables 7 - 12 relate to results at a single concentration of test compound ( 10 μm ). they are followed by data showing results at other concentrations . many compounds showed a “ cross - over ” effect in which the test compound was less active than piperine at 10 μm but more active at 50 μm . this is illustrated for one compound ( rv - a01 ) in fig8 of the drawings . [ 0145 ] table 7 effect on melan - a cells at μm concentration percentage cell growth relative variation on nitrogen substituent of piperine ( repeated experiments stimulant activity to den - code n o structure test cpd . piperine activity piperine dricity rv - a01 183 ± 34 ** 202 ± 84 * 180 ± 50 ** 191 ± 63 * positive 1 . 03 1 . 01 +++ rv - a02 156 ± 58 187 ± 40 ** 153 ± 19 ** 210 ± 65 ** 170 ± 22 155 ± 19 ** positive 0 . 5 1 . 02 0 . 9 +++ rv - a04 149 ± 47 119 ± 27 147 ± 22 170 ± 39 ** 169 ± 29 ** 173 ± 28 ** non - significant here , but positive in dose response test 0 . 7 0 . 27 . 066 + rv - a05 166 ± 35 140 ± 17 * 170 ± 39 ** 169 ± 29 ** positive 0 . 93 0 . 57 +++ rv - a06 147 ± 66 158 ± 24 ** 156 ± 40 ** 170 ± 39 ** 169 ± 29 ** 155 ± 18 ** positive 1 . 69 0 . 83 1 . 0 +++ rv - a07 170 ± 24 * 216 ± 33 * positive 0 . 6 ++ rv - a08 200 ± 14 236 ± 17 positive 0 . 73 +++ rc - a09 224 ± 19 263 ± 16 ** positive 0 . 76 +++ rv - a10 308 ± 29 ** 302 ± 17 ** positive 1 . 02 +++ rv - a11 264 ± 21 ** 347 ± 14 ** positive 0 . 66 +++ [ 0146 ] table 8 effect on melan - a cells at μm concentration variation in connecting chain length and amide percentage cell growth relative group ( repeated experiments ) stimulant activity to code n o structure test piperine activity piperine dendricity rv - b01 171 ± 33 ** 148 ± 20 152 ± 22 ** 180 ± 50 ** 191 ± 63 ** 155 ± 18 ** positive 0 . 88 0 . 52 0 . 97 ++ rv - b02 140 ± 14 154 ± 33 135 ± 4 180 ± 50 ** 191 ± 63 ** 155 ± 18 ** non - significant 0 . 2 0 . 59 0 . 63 + rv - b03 103 ± 12 116 ± 17 210 ± 65 ** 170 ± 22 ** none 0 . 02 0 . 22 − [ 0147 ] table 9 effect on melan - a cells at μm concentration percentage cell growth relative replacement of amide by ester group ( repeated experiments ) stimulant activity to code n o structure test piperine activity piperine dendricity rv - ab1 163 ± 38 141 ± 18 * 151 ± 7 * 210 ± 65 ** 170 ± 22 ** 155 ± 18 ** positive 0 . 57 0 . 59 0 . 93 ++ rv - ab2 29 ± 9 22 ± 0 . 4 171 ± 39 ** 171 ± 39 ** positive − 1 − 1 . 09 toxic rv - ab4 224 ± ** 255 ± ** positive 0 . 8 ++ rv - ab5 166 ± 35 ** 169 ± 29 ** positive 0 . 95 ++ rv - ab6 148 ± 18 ** 181 ± 11 ** positive 0 . 59 + [ 0148 ] table 10 effect on melan - a cells at μm concentration replacement of amide by ester group and percentage cell growth relative variation in connecting chain length ( repeated experiments ) stimulant activity to code n o structure test piperine activity piperine dendricity rv - bb1 149 ± 27 129 ± 15 121 ± 12 210 ± 65 ** 170 ± 22 ** 155 ± 18 ** non - sigmificant 0 . 44 0 . 41 0 . 39 + [ 0149 ] table 11 effect on melan - a cells at μm concentration reduction of double bonds in connecting chain and variation in percentage cell growth relative chain length ( repeated experiments ) stimulant activity to code n o structure test piperine activity piperine dendricity rv - c02 169 ± 29 ** 195 ± 89 ** 180 ± 50 ** 191 ± 63 ** positive 0 . 8 1 . 04 +++ rv - c03 104 ± 5 113 ± 2 171 ± 7 ** 171 ± 7 ** none 0 . 056 0 . 18 + rv - c04 192 ± 5 ** 216 ± 18 ** posotive 0 . 79 +++ rv - c05 160 ± 5 ** 192 ± 2 ** positive 0 . 65 ++ [ 0150 ] table 12 effect on melan - a cells at μm concentration variation in the phenyl substituent and percentage cell growth relative connecting chain length ( repeated experiments ) stimulant activity to code n o structure test piperine activity piperine dendricity rv - g01 105 ± 8 202 ± 29 ** none 0 . 04 rv - g02 119 ± 18 87 ± 17 171 ± 39 ** 171 ± 7 ** negative 0 . 26 − 0 . 18 − rv - g03 121 ± 8 122 ± 8 * 171 ± 39 ** 171 ± 7 ** non - significant 0 . 29 0 . 30 − rv - g04 100 ± 9 224 ± 11 ** none 0 − [ 0151 ] code n o structure rv - a01 com - pounds tested 1 μm 10 μm 25 μm 50 μm piperine 151 ± 7 **♦ 202 ± 12 **♦ 171 ± 15 **♦ 142 ± 9 ** rv - a01 109 ± 7 122 ± 7 142 ± 21 ** 186 ± 14 ** [ 0152 ] code n o structure rv - a02 com - pounds tested 1 μm 10 μm 25 μm 50 μm piperine 147 ± 11 **♦ 192 ± 13 **♦ 167 ± 19 ** 142 ± 15 ** rv - a02 125 ± 10 167 ± 17 ** 171 ± 8 ** 168 ± 12 ** [ 0153 ] code n o structure rv - a04 compounds tested 1 μm 10 μm 50 μm 100 μm piperine 120 ± 11 178 ± 11 **♦ 116 ± 13 92 ± 9 rv - a04 101 ± 12 138 ± 10 ** 150 ± 15 ** 71 ± 9 dentricity − + + rv - a04 [ 0154 ] code n ° structure rv - a05 compounds tested 1 μm 1 μm 25 μm 5 μm piperine 173 ± 6 **♦ 230 ± 13 **♦ 188 ± 19 ** 182 ± 15 ** rv - a05 155 ± 9 ** 188 ± 13 ** 178 ± 18 ** 174 ± 8 ** [ 0155 ] code n ° structure rv - a06 compounds tested 1 μm 10 μm 25 μm 5 μm piperine 147 ± 8 ♦ 195 ± 22 ** 173 ± 17 * 159 ± 14 rv - a06 134 ± 7 188 ± 14 ** 172 ± 15 * 135 ± 24 [ 0156 ] code n ° structure rv - a07 compounds tested 1 μm 10 μm 50 μm 100 μm piperine 211 ± 16 **♦ 216 ± 33 ** 52 ± 15 16 ± 3 rv - a07 140 ± 12 ** 170 ± 24 ** 71 ± 5 46 ± 2 dentricity ++ ++ + + of rv - a07 [ 0157 ] code n ° structure rv - a08 compounds tested 1 μm 10 μm 50 μm 100 μm piperine 216 ± 14 **♦ 236 ± 17 ** 61 ± 11 32 ± 5 rv - a08 139 ± 27 ** 200 ± 14 ** 81 ± 12 62 ± 13 dendricity ++ +++ + + of rv - a08 [ 0158 ] code n ° structure rv - a09 compounds tested 1 μm 10 μm 50 μm 100 μm piperine 221 ± 17 **♦ 263 ± 16 ** 77 ± 12 24 ± 2 rv - a09 187 ± 15 ** 224 ± 19 ** 85 ± 5 42 ± 6 dendricity +++ +++ + + of rv - a09 [ 0159 ] code n ° structure rv - a10 compounds tested 1 μm 10 μm 50 μm 100 μm piperine 236 ± 30 ** 302 ± 17 ** 78 ± 11 21 ± 4 rv - a10 301 ± 20 ** 308 ± 29 ** 155 ± ** 100 ± 13 dendricity +++ +++ ++ + of rv - a10 [ 0160 ] code n ° structure rv - a11 compounds tested 1 μm 10 μm 50 μm 100 μm piperine 251 ± 19 **♦ 347 ± 14 **♦ 61 ± 7 25 ± 2 rv - a11 189 ± 6 ** 264 ± 21 ** 158 ± 20 ** 84 ± 6 dendncity +++ +++ ++ + of rv - a11 [ 0161 ] code n ° structure rv - b01 compounds tested 1 μm 10 μm 25 μm 50 μm piperine 144 ± 27 **♦ 190 ± 7 ** 172 ± 11 ** 153 ± 10 ** rv - b01 111 ± 6 147 ± 7 ** 187 ± 18 ** 187 ± 8 ** [ 0162 ] code n ° structure rv - ab1 compounds tested 1 μm 10 μm 50 μm 100 μm piperine 133 ± 31 ** 177 ± 14 **♦ 139 ± 16 * 95 ± 24 rv - ab1 125 ± 13 147 ± 16 ** 187 ± 12 ** 171 ± 8 ** dendricity − + ++ ++ of rv - ab1 [ 0163 ] code n ° structure rv - ab4 compounds tested 1 μm 10 μm 50 μm 100 μm piperine 223 ± 18 **♦ 255 ± 15 ** 60 ± 16 24 ± 6 rv - ab4 175 ± 6 ** 224 ± 12 ** 148 ± 19 ** 90 ± 7 dendricity ++ ++ ++ + of rv - ab4 [ 0164 ] code n ° structure rv - ab5 compounds tested 1 μm 10 μm 50 μm 100 μm piperine 141 ± 26 **♦ 220 ± 29 **♦ 45 ± 12 23 ± 4 rv - ab5 120 ± 21 151 ± 19 ** 163 ± 8 ** 123 ± 8 dendricity − ++ ++ + of rv - ab5 [ 0165 ] code n ° structure rv - ab6 compounds tested 1 μm 10 μm 50 μm 100 μm piperine 113 ± 10 181 ± 11 ** 43 ± 6 23 ± 6 rv - ab6 103 ± 5 148 ± 18 ** 190 ± 11 ** 128 ± 17 ** dendricity − + ++ + of rv - ab6 [ 0166 ] code n ° structure rv - c02 compounds tested 1 μm 10 μm 25 μm 50 μm piperine 158 ± 10 **♦ 203 ± 11 ** 188 ± 12 ** 164 ± 6 ** rv - c02 134 ± 15 ** 183 ± 33 ** 199 ± 31 ** 175 ± 12 ** [ 0167 ] rv - c04 code n ° structure rv - c04 compound 1 μm 10 μm 50 μm 100 μm piperine 191 ± 12 **♦ 216 ± 18 ** 184 ± 6 ** 96 ± 6 rv - c04 129 ± 6 ** 192 ± 6 ** 192 ± 10 ** 191 ± 12 ** dendricity of + +++ +++ +++ rv - c04 [ 0168 ] rv - c05 code n ° structure rv - c05 compound 1 μm 10 μm 50 μm 100 μm piperine 161 ± 13 ** 192 ± 2 **♦ 189 ± 15 ** 87 ± 13 rv - c05 118 ± 1 160 ± 5 **♦ 158 ± 19 ** 113 ± 15 dendricity of + ++ ++ + rv - c05 [ 0169 ] code n ° structure rv - g01 compounds tested 1 μm 10 μm 50 μm 100 μm piperine 161 ± 23 ** 202 ± 29 ** 61 ± 5 40 ± 7 rv - g01 99 ± 8 105 ± 8 103 ± 6 119 ± 9 dendricity − − − − of rv - g01 [ 0170 ] code n ° structure rv - g02 compounds tested 1 μm 10 μm 50 μm 100 μm piperine 151 ± 17 ** 201 ± 15 ** 57 ± 15 39 ± 11 rv - g02 99 ± 5 95 ± 18 110 ± 11 127 ± 9 dendricity − − − − of rv - g02 [ 0171 ] code n ° structure rv - g03 compounds tested 1 μm 10 μm 50 μm 100 μm piperine 163 ± 9 ** 181 ± 23 ** 59 ± 11 40 ± 12 rv - g03 90 ± 10 108 ± 20 111 ± 10 133 ± 15 ** dendricity − − − − of rv - g03 [ 0172 ] code n ° structure rv - g04 compounds tested 1 μm 10 μm 50 μm 100 μm piperine 179 ± 12 ** 224 ± 11 ** 92 ± 19 35 ± 4 rv - g04 95 ± 11 100 ± 9 114 ± 8 123 ± 7 * dendricity − − − − of rv - g04 to piperine ( 1 ) ( 2 g , 0 . 7 mmol , 1 eq ), 20 % of methanolic koh ( 100 ml ) was added and refluxed for 2 days . after completion of the hydrolysis , methanol was removed under reduced pressure and a yellow coloured oily solid was obtained . this residue was dissolved in water ( 50 ml ) and acidified with 6n hcl to ph & lt ; 1 yielding a yellowish precipitate of piperinic acid . recrystallization from methanol gave yellow needles ( 0 . 9 g , 60 % yield ). m . p . 206 °- 208 ° c . ( lit m . p . 217 °- 218 ° c .) 1 a mixture of piperinic acid ( 350 mg , 0 . 0016 mole , 1 eq ) and triethylamine ( 0 . 4 ml , 0 . 0032 mole , 2 eq ) in dichloromethane ( 50 ml ) was stirred for 15 min at 0 ° c . to this mixture methanesulfonyl chloride ( 0 . 18 ml , 0 . 0024 mole , 1 . 5 eq ) was added and stirred for further 30 min at 0 ° c . isobutylamine ( 0 . 23 ml , 0 . 0024 mole , 1 . 5 eq ) was added to the mixture and stirred for 1 h at 0 ° c . and 2 h at room temperature . dichloromethane ( 50 ml ) was added to the mixture which was then washed with 5 % hcl ( 3 × 100 ml ), saturated aqueous nahco 3 ( 3 × 100 ml ) and water ( 3 × 100 ml ). the organic fraction was dried over anhydrous sodium sulphate , filtered and rotary evaporated to yield a yellowish solid residue . recrystallisation from methanol yielded colourless needles of piperlonguminine ( 120 mg , 32 % yield ) 2 . the reaction is presumed to proceed through a mesylate ester intermediate . [ 0179 ] 1 h - nmr ( cdcl 3 ) δ : 5 . 96 ( d , 1h , j = 14 . 8 , ch ═ ch — ch ═ ch ), 7 . 36 ( d , d , 1h , j = 10 . 5 , 14 . 8 , ch ═ ch — ch ═ ch ), 6 . 66 ( d , d , 1h , j = 15 . 4 , 10 . 5 , ch ═ ch — ch ═ ch ), 6 . 76 ( d , 1h , j = 15 . 4 ch ═ ch — ch ═ ch ), 6 . 96 ( d , 1h j = 1 . 6 , ar - 7h ), 6 . 76 ( d , 1h j = 8 . 0 , ar - 10h ), 6 . 87 ( d , d , 1h j = 1 . 6 , 8 . 0 ar - 11h ), 5 . 97 ( s , 2h , o — ch 2 — o ), 3 . 18 ( t , 2h , j = 6 . 5 ch 2 — ch ), 1 . 83 ( m , 1h , j = 6 . 5 ch 2 — ch ), 0 . 94 ( d , 6h , j = 6 . 5 , ( ch 3 ) 2 ), [ 0181 ] 13 c - nmr ( cdcl 3 ): 20 . 4 ( ch 3 ), 29 . 4 ( ch ), 47 . 3 ( ch 2 ), 102 . 2 ( ch 2 ), 106 . 2 ( ch ), 109 . 1 ( ch ), 123 . 3 ( ch ), 125 . 5 ( ch ), 126 . 0 ( ch ), 132 . 0 ( c ), 138 . 0 ( ch ), 140 . 4 ( ch ), 148 . 9 ( c ), 149 . 2 ( c ), 166 . 2 ( c ) ms m / z (%): 273 ( m + 98 ), 216 ( 20 ), 201 ( 100 ), 174 ( 25 ), 173 ( 65 ), 172 ( 23 ), 171 ( 17 ) 143 ( 20 ), 115 ( 40 ), 96 ( 11 ). the general method was as for piperlonguminine ( section 1 . 2 ), using the same proportions of reactive amine , triethylamine and methanesulfonyl chloride relative to piperinic acid ( 200 or 300 mg ., 1 eq ). recrystallisation from ethyl acetate / petroleum spirit yielded the other amide derivatives of piperinic acid . [ 0188 ] 1 h - nmr ( cdcl 3 ) δ : 6 . 26 ( d , 1h , j = 14 . 7 , ch ═ ch — ch ═ ch ), 7 . 43 ( d , d , 1h , j = 9 . 5 , 14 . 7 , ch ═ ch — ch ═ ch ), 6 . 73 ( d , d , 1h , j = 15 . 3 , 9 . 5 , ch ═ ch — ch ═ ch ), 6 . 78 ( d , 1h , j = 15 . 3 ch ═ ch — ch ═ ch ), 6 . 98 ( d , 1h j = 1 . 6 , ar - 7 - h ), 6 . 77 ( d , 1h j = 8 . 0 , ar - 10 - h ), 6 . 89 ( d , d , 1h j = 1 . 6 , 8 . 0 ar - 11 - h ), 5 . 97 ( s , 2h , o — ch 2 — o ), 3 . 57 ( t , 2h , j = 4 . 0 n — ch 2 ( pyrrolidine )) 3 . 54 ( t , 2h , j = 4 . 0 n — ch 2 ( pyrrolidine ) 1 . 90 ( m , 2h , ch 2 — ch 2 ( pyrrolidine )) 1 . 87 ( m , 2h , ch 2 — ch 2 ( pyrrolidine )) [ 0189 ] 13 c - nmr ( cdcl 3 ): 24 . 3 ( ch 2 ), 26 . 1 ( ch 2 ), 45 . 9 ( ch 2 ), 46 . 4 ( ch 2 ), 101 . 2 ( ch 2 ), 105 . 7 ( ch ), 108 . 4 ( ch ), 121 . 4 ( ch ), 122 . 5 ( ch ), 125 . 2 ( ch ), 130 . 9 ( c ), 138 . 7 ( ch ), 141 . 7 ( ch ), 148 . 1 ( c ), 148 . 2 ( c ), 164 . 9 ( c ) ms m / z (%): 271 ( m + 78 ), 201 ( 100 ), 173 ( 30 ), 172 ( 15 ), 171 ( 13 ) 143 ( 13 ), 115 ( 27 ) [ 0194 ] 1 h - nmr ( cdcl 3 ) δ : 6 . 37 ( d , 1h , j = 14 . 6 , ch ═ ch — ch ═ ch ), 7 . 45 ( d , d , 1h , j = 10 . 2 , 14 . 6 , ch ═ ch — ch ═ ch ), 6 . 72 ( d , d , 1h , j = 15 . 5 , 10 . 2 , ch ═ ch — ch ═ ch ), 6 . 79 ( d , 1h , j = 15 . 5 ch ═ ch — ch ═ ch ), 6 . 98 ( d , 1h j = 1 . 5 , ar - 7 - h ), 6 . 80 ( d , 1h j = 8 . 0 , ar - 10 - h ), 6 . 89 ( d , d , 1h j = 1 . 5 , 8 . 0 ar - 11 - h ), 5 . 98 ( s , 2h , o — ch 2 — o ), 3 . 70 ( t , 2h , j = 4 . 0 ch 2 — n — ch 2 ( morpholine )) 3 . 60 ( t , 2h , j = 4 . 0 ch 2 — o — ch 2 ( morpholine )) [ 0195 ] 13 c - nmr ( cdcl 3 ): 42 . 3 ( ch 2 ), 46 . 1 ( ch 2 ), 66 ( ch 2 ), 66 ( ch 2 ), 101 . 3 ( ch 2 ), 106 . 5 ( ch ), 108 . 5 ( ch ), 118 . 7 ( ch ), 122 . 7 ( ch ), 124 . 9 ( ch ), 130 . 8 ( c ), 139 . 1 ( ch ), 143 . 4 ( ch ), 148 . 2 ( c ), 148 . 3 ( c ), 165 . 6 ( c ) ms m / z (%): 287 ( m + 57 ), 201 ( 100 ), 173 ( 25 ), 171 ( 10 ) 143 ( 10 ), 115 ( 30 ) [ 0200 ] 1 h - nmr ( cdcl 3 ) δ : 5 . 98 ( d , 1h , j = 14 . 9 , ch ═ ch — ch ═ ch ), 7 . 34 ( d , d , 1h , j = 10 . 7 , 14 . 9 , ch ═ ch — ch ═ ch ), 6 . 73 ( d , d , 1h , j = 15 . 5 , 10 . 7 , ch ═ ch — ch ═ ch ), 6 . 79 ( d , 1h , j = 15 . 5 ch ═ ch — ch ═ ch ), 6 . 98 ( d , 2h j = 1 . 5 , ar - 7 , 3 ′- h ), 6 . 78 ( d , 2h j = 8 . 0 , ar - 10 , 6 ′- h ), 6 . 89 ( d , d , 2h j = 1 . 6 , 8 . 0 ar - 11 , 7 ′- h ), 5 . 98 ( s , 2h , o — ch 2 — o ), 5 . 93 ( s , 2h , o — ch 2 — o ), 4 . 40 ( d , 2h , ch 2 ) 3 . 57 ( br , 1h , nh ) [ 0201 ] 13 c - nmr ( cdcl 3 ): 43 . 4 ( ch 2 ), 101 . 1 ( ch 2 ), 101 . 4 ( ch 2 ), 105 . 8 ( ch ), 108 . 3 ( ch ) 108 . 5 ( ch ), 108 . 6 ( ch ), 121 . 2 ( ch ), 122 . 8 ( ch ), 124 . 7 ( ch ), 130 . 9 ( c ), 132 . 2 ( c ) 139 . 9 ( ch ), 141 . 6 ( ch ), 147 . 0 ( c ) 147 . 9 ( c ) 148 . 3 ( c ), 148 . 4 ( c ), 166 . 9 ( c ) ms m / z (%): 351 ( m + 81 ), 216 ( 15 ), 203 ( 12 ), 202 ( 53 ) 201 ( 29 ), 174 ( 31 ), 173 ( 22 ), 150 ( 23 ) 144 ( 11 ), 143 ( 10 ), 135 ( 100 ), 116 ( 12 ) 115 ( 29 ) [ 0205 ] 1 h - nmr ( cdcl 3 ) δ : 5 . 90 ( d , 1h , j = 14 . 8 , ch ═ ch — ch ═ ch ), 7 . 35 ( d , d , 1h , j = 10 . 6 , 14 . 8 , ch ═ ch — ch ═ ch ), 6 . 66 ( d , d , 1h , j = 15 . 4 , 10 . 6 , ch ═ ch — ch ═ ch ), 6 . 76 ( d , 1h , j = 15 . 4 ch ═ ch — ch ═ ch ), 6 . 97 ( d , 1h j = 1 . 4 , ar - 7h ), 6 . 77 ( d , 1h j = 8 . 0 , ar - 10h ), 6 . 88 ( d , d , 1h j = 1 . 5 , 8 . 0 ar - 11h ), 5 . 97 ( s , 2h , o — ch 2 — o ), 3 . 34 ( q , 2h , ch 2 — ch 2 — ch 2 — ch 2 — ch 2 ) 1 . 54 ( m , 2h , ch 2 — ch 2 — ch 2 — ch 2 — ch 2 ) 1 . 32 ( m , 6h , ch 2 — ch 2 — ch 2 — ch 2 — ch 2 ) 0 . 88 ( t , 3h , ch 3 ), 5 . 54 ( br , nh ) [ 0206 ] 13 c - nmr ( cdcl 3 ): 14 . 3 ( ch 3 ), 22 . 5 ( ch 2 ), 26 . 6 ( ch 2 ), 29 . 6 ( ch 2 ), 31 . 5 ( ch 2 ), 39 . 7 ( ch 2 ), 101 . 3 ( ch 2 ), 105 . 7 ( ch ), 108 . 5 ( ch ), 122 . 5 ( ch ), 123 . 2 ( ch ), 124 . 6 ( ch ), 130 . 8 ( c ), 138 . 7 ( ch ), 140 . 9 ( ch ) 148 . 2 ( c ), 148 . 2 ( c ), 166 . 0 ( c ) ms m / z (%): 301 ( m + 94 ), 202 ( 18 ) 201 ( 73 ), 174 ( 40 ), 173 ( 100 ), 172 ( 31 ), 171 ( 15 ) 143 ( 24 ), 115 ( 63 ) [ 0211 ] 1 h - nmr ( cdcl 3 ) δ : 5 . 91 ( d , 1h , j = 14 . 8 , ch ═ ch — ch ═ ch ), 7 . 36 ( d , d , 1h , j = 10 . 7 , 14 . 8 , ch ═ ch — ch ═ ch ), 6 . 66 ( d , d , 1h , j = 15 . 4 , 10 . 6 , ch ═ ch — ch ═ ch ), 6 . 77 ( d , 1h , j = 15 . 4 ch ═ ch — ch ═ ch ), 6 . 97 ( d , 1h j = 1 . 5 , ar - 7h ), 6 . 77 ( d , 1h j = 8 . 0 , ar - 10h ), 6 . 88 ( d , d , 1h j = 1 . 6 , 8 . 0 ar - 11h ), 5 . 97 ( s , 2h , o — ch 2 — o ), 2 . 91 ( t , 3h , ch 3 ), 5 . 61 ( br , nh ) [ 0212 ] 13 c - nmr ( cdcl 3 ): 26 . 9 ( ch 3 ), 101 . 7 ( ch 2 ), 106 . 1 ( ch ), 108 . 9 ( ch ), 123 . 0 ( ch ), 123 . 3 ( ch ), 125 . 0 ( ch ), 131 . 2 ( c ), 139 . 2 ( ch ), 141 . 4 ( ch ), 148 . 6 ( c ), 148 . 6 ( c ), 167 . 2 ( c ) ms m / z (%): 231 ( m + 89 ), 201 ( 42 ), 173 ( 67 ), 172 ( 32 ), 171 ( 17 ), 143 ( 27 ), 116 ( 21 ) 115 ( 100 ), 89 ( 12 ) [ 0216 ] 1 h - nmr ( cd 3 od ) δ : 6 . 14 ( d , 1h , j = 15 . 0 , ch ═ ch — ch ═ ch ), 7 . 37 ( d , d , 1h , j = 10 . 2 , 15 . 0 , ch ═ ch — ch ═ ch ), 6 . 93 ( d , d , 1h , j = 15 . 7 , 10 . 6 , ch ═ ch — ch ═ ch ), 6 . 87 ( d , 1h , 3 = 15 . 7 ch ═ ch — ch ═ ch ), 6 . 97 ( d , 1h j = 1 . 5 , ar - 7h ), 6 . 77 ( d , 1h j = 8 . 0 , ar - 11h ), 6 . 88 ( d , d , 1h j = 1 . 6 , 8 . 0 ar - 11h ), 5 . 97 ( s , 2h , o — ch 2 — o ), 3 . 39 ( m , 2h , j = 6 . 2 , ch 2 ), 1 . 22 ( t , 3h , j = 6 . 1 , ch 3 ), [ 0217 ] 13 c - nmr ( cdcl 3 ): 14 . 7 ( ch 3 ), 36 . 9 ( ch 2 ), 103 . 2 ( ch 2 ), 107 . 2 ( ch ), 109 . 8 ( ch ), 121 . 2 ( ch ), 124 . 9 ( ch ), 125 . 9 ( ch ), 132 . 4 ( c ), 142 . 9 ( ch ), 145 . 2 ( ch ), 150 . 2 ( c ), 150 . 6 ( c ), 170 ( c ) ms m / z (%): 245 ( m + 78 ), 218 ( 34 ), 201 ( 71 ), 200 ( 49 ), 174 ( 64 ), 173 ( 80 ), 172 ( 76 ), 171 ( 65 ), 143 ( 75 ), 116 ( 68 ), 115 ( 100 ) [ 0221 ] 1 h - nmr ( cdcl 3 ) δ : 5 . 87 ( d , 1h , j = 14 . 8 , ch ═ ch — ch ═ ch ), 7 . 36 ( d , d , 1h , j = 10 . 7 , 14 . 8 , ch ═ ch — ch ═ ch ), 6 . 66 ( d , d , 1h , j = 15 . 4 , 10 . 6 , ch ═ ch — ch ═ ch ), 6 . 76 ( d , 1h , j = 15 . 2 ch ═ ch — ch ═ ch ), 6 . 97 ( d , 1h j = 1 . 6 , ar - 7h ), 6 . 77 ( d , 1h j = 8 . 0 , ar - 10h ), 6 . 88 ( d , d , 1h j = 1 . 6 , 8 . 0 ar - 11h ), 5 . 97 ( s , 2h , o — ch 2 — o ), 4 . 15 ( m , 1h , j = 6 . 6 , ch ), 5 . 36 ( d , 1h , j = 7 . 3 nh ), 1 . 19 ( d , 6h , j = 6 . 6 , ( ch 3 ) 2 ) [ 0222 ] 13 c - nmr ( cdcl 3 ): 23 . 2 ( ch 3 ) 2 , 41 . 9 ( ch ), 101 . 9 ( ch 2 ), 106 . 4 ( ch ), 108 . 9 ( ch ), 123 . 0 ( ch ), 123 . 8 ( ch ), 124 . 1 ( ch ), 131 . 3 ( c ), 140 . 2 ( ch ), 141 . 2 ( ch ), 148 . 8 ( c ), 148 . 6 ( c ) 165 . 6 ( c ) ms m / z (%): 259 ( m + 80 ), 201 ( 62 ), 174 ( 34 ), 173 ( 74 ), 172 ( 31 ), 171 ( 15 ), 143 ( 30 ), 116 ( 16 ), 115 ( 100 ) [ 0226 ] 1 h - nmr ( cdcl 3 ) δ : 5 . 93 ( d , 1h , j = 14 . 8 , ch ═ ch — ch ═ ch ), 7 . 35 ( d , d , 1h , j = 10 . 6 , 14 . 8 , ch ═ ch — ch ═ ch ), 6 . 66 ( d , d , 1h , j = 15 . 3 , 10 . 6 , ch ═ ch — ch ═ ch ), 6 . 76 ( d , 1h , j = 15 . 4 ch ═ ch — ch ═ ch ), 6 . 96 ( d , 1h j = 1 . 6 , ar - 7h ), 6 . 76 ( d , 1h j = 8 . 0 , ar - 10h ), 6 . 87 ( d , d , 1h j = 1 . 6 , 8 . 0 ar - 11h ), 5 . 97 ( s , 2h , o — ch 2 — o ), 3 . 87 ( m , 1h , ch ( cyclohexyl )) 1 . 99 ( m , 2h , ch 2 ( cyclohexyl )) 1 . 65 ( m , 4h , ch 2 — ch 2 ( cyclohexyl ) 1 . 39 ( m , 2h , ch 2 ( cyclohexyl )) 1 . 18 ( m , 2h , ch 2 ( cyclohexyl )) 5 . 48 ( d , j = 8 . 0 nh ) [ 0227 ] 13 c - nmr ( cdcl 3 ): 25 . 3 (( ch 2 ) 2 ), 25 . 9 ( ch 2 ), 33 . 6 (( ch 2 ) 2 ), 48 . 6 ( ch ), 101 . 3 ( ch 2 ), 101 . 7 ( ch ), 106 . 1 ( ch ), 108 . 9 ( ch ), 123 . 0 ( ch ), 124 . 0 ( ch ), 125 . 1 ( ch ), 131 . 3 ( c ), 139 . 0 ( ch ), 141 . 2 ( ch ) 148 . 5 ( c ), 148 . 5 ( c ), 165 . 5 ( c ) ms m / z (%): 299 ( m + 56 ), 259 ( 48 ) 216 ( 33 ), 201 ( 60 ), 174 ( 33 ), 173 ( 61 ), 172 ( 18 ), 171 ( 16 ) 143 ( 17 ), 115 ( 100 ) [ 0231 ] 1 h - nmr ( cdcl 3 ) δ : 5 . 97 ( d , 1h , j = 14 . 8 , ch ═ ch — ch ═ ch ), 7 . 35 ( d , d , 1h , j = 10 . 7 , 14 . 8 , ch ═ ch — ch ═ ch ), 6 . 66 ( d , d , 1h , j = 15 . 4 , 10 . 6 , ch ═ ch — ch ═ ch ), 6 . 76 ( d , 1h , j = 15 . 4 ch ═ ch — ch ═ ch ), 6 . 97 ( d , 1h j = 1 . 6 , ar - 7h ), 6 . 77 ( d , 1h j = 8 . 0 , ar - 10h ), 6 . 89 ( d , d , 1h j = 1 . 5 , 8 . 0 ar - 11h ), 5 . 97 ( s , 2h , o — ch 2 — o ), 3 . 36 ( q , 2h , ch 2 — ch 2 — ch 2 —) 1 . 54 ( m , 2h , ch 2 — ch 2 — ch 2 ) 1 . 39 ( m , 6h , ch 2 — ch 2 — ch 2 ) 0 . 93 ( t , 3h , ch 3 ), 5 . 47 ( br , nh ) [ 0232 ] 13 c - nmr ( cdcl 3 ): 14 . 2 ( ch 3 ), 20 . 5 ( ch 2 ), 32 . 2 ( ch 2 ), 39 . 8 ( ch 2 ), 101 . 7 ( ch 2 ), 106 . 1 ( ch ), 108 . 9 ( ch ), 123 . 0 ( ch ), 123 . 6 ( ch ), 125 . 0 ( ch ), 131 . 3 ( c ), 139 . 2 ( ch ), 141 . 3 ( ch ) 148 . 6 ( c ), 148 . 6 ( c ), 166 . 4 ( c ) [ 0234 ] 1 chatterjee , a ., and dutta , c . p . ( 1967 ). alkaloids of piper longuim linn - i structure and synthesis of piperlonguminine and piperlonguminine , tetrahedron , 23 , 1769 - 1781 . [ 0235 ] 2 nokio nakumara , fumiyuki kiuchi , and yoshisuke tsuda ( 1988 ). infrared spectra of conjugated amides : reassigrnment of the c ═ o and c ═ c absorptions : chemical and pharmaceutical bulletin , 36 , 2647 - 2651 . [ 0236 ] 3 h . oediger and a . schulze ( bayer ag ), ( 1979 ), deutsche auslegeschrift 2757 483 [ 0237 ] 4 paula , vanderlucia f . de ; a barbosa , luiz c . de ; demuner , antonio j . ; pilo - veloso , dorila ; picanco , marcelo c . ( 2000 ) pest management science 56 , 2 , 168 - 174 . [ 0238 ] 5 gokale et al ., ( 1948 ) journal of university bombay science 16 / 5a 32 - 35 a mixture of piperinic acid ( 300 mg , 0 . 0014 mole , 1 eq ) and triethylamine ( 0 . 39 ml , 0 . 0028 mole , 2 eq ) in dichloromethane ( 50 ml ) was stirred for 15 min at 0 ° c . to this mixture methanesulfonyl chloride ( 0 . 16 ml , 0 . 0021 mole , 1 . 5 eq ) was added and stirred for further 30 min at 0 ° c . methanol in excess ( 10 ml ) was added to the mixture and stirred for 1 h at 0 ° c . and 1 h at room temperature . dichloromethane ( 50 ml ) was added to the mixture which was then washed with water ( 3 × 100 ml ), 5 % nahco 3 ( 3 × 100 ml ) and water ( 3 × 100 ml ). the organic fraction was dried over anhydrous sodium sulphate , filtered and rotary evaporated to yield a yellowish solid residue . recrystallisation from ethyl acetate / petroleum spirit yielded ester ( 180 mg , 56 . 2 % yield ). m . p . 142 . 9 °- 143 ° c . ( lit m . p . 140 ° c .) 6 they were synthesised as described in section 3 . 2 , replacing methanol ( 10 ml ) ethanol ( 10 ml ), isopropanol , butanol or propanol ( 15 ml ). [ 0247 ] 1 h - nmr ( cdcl 3 ) δ : 5 . 94 ( d , 1h , j = 15 . 2 , ch ═ ch — ch ═ ch ), 7 . 41 ( d , d , 1h , j = 10 . 8 , 15 . 2 , ch ═ ch — ch ═ ch ), 6 . 70 ( d , d , 1h , j = 15 . 4 , 10 . 8 , ch ═ ch — ch ═ ch ), 6 . 81 ( d , 1h , j = 15 . 7 ch ═ ch — ch ═ ch ), 6 . 99 ( d , 1h j = 1 . 6 , ar - 7h ), 6 . 79 ( d , 1h j = 8 . 1 , ar - 10h ), 6 . 91 ( d , d , 1h j = 1 . 5 , 8 . 1 ar - 11h ), 5 . 98 ( s , 2h , o — ch 2 — o ), 3 . 57 ( t , 3h , br , och 3 j = 4 . 7 ) [ 0248 ] 13 c - nmr ( cdcl 3 ) δ : 51 . 5 ( ch 3 ), 101 . 8 ( ch 2 ), 106 . 2 ( ch ) 108 . 9 ( ch ), 120 . 0 ( ch ), 123 . 4 ( ch ) 124 . 7 ( ch ), 130 . 8 ( ch ), 140 . 9 ( c ), 145 . 5 ( ch ), 148 . 6 ( c ), 148 . 9 ( c ), 168 . 9 ( c ) ms m / z (%): 232 ( m + 69 ), 201 ( 19 ), 174 ( 12 ), 173 ( 100 ), 172 ( 39 ), 171 ( 12 ) 143 ( 33 ), 116 ( 11 ), 115 ( 53 ) 101 ( 15 ), 100 ( 12 ) [ 0251 ] 1 h - nmr ( cdcl 3 ) δ : 5 . 94 ( d , 1h , j = 15 . 2 , ch ═ ch — ch ═ ch ), 7 . 41 ( d , d , 1h , j = 10 . 8 , 15 . 3 , ch ═ ch — ch ═ ch ), 6 . 70 ( d , d , 1h , j = 15 . 4 , 10 . 8 , ch ═ ch — ch ═ ch ), 6 . 81 ( d , 1h , j = 15 . 5 ch ═ ch — ch ═ ch ), 6 . 99 ( d , 1h j = 1 . 6 , ar - 7h ), 6 . 78 ( d , 1h j = 8 . 1 , ar - 10h ), 6 . 91 ( d , d , 1h j = 1 . 6 , 8 . 1 ar - 11h ), 5 . 98 ( s , 2h , o — ch 2 — o ), 4 . 22 ( q , 2h , och 2 j = 7 . 2 ), 1 . 31 ( t , 3h , ch 3 j = 7 . 2 ) [ 0252 ] 13 c - nmr ( cdcl 3 ): 14 . 7 ( ch 3 ), 60 . 7 ( ch 2 ), 101 . 6 ( ch 2 ), 106 . 3 ( ch ) 108 . 9 ( ch ), 120 . 8 ( ch ), 123 . 3 ( ch ) 124 . 9 ( ch ), 131 . 0 ( ch ), 140 . 5 ( ch ), 145 . 1 ( ch ), 148 . 7 ( c ), 148 . 9 ( c ), 167 . 6 ( c ) [ 0256 ] 1 h - nmr ( cdcl 3 ) δ : 5 . 94 ( d , 1h , j = 15 . 2 , ch ═ ch — ch ═ ch ), 7 . 41 ( d , d , 1h , j = 10 . 7 , 15 . 2 , ch ═ ch — ch ═ ch ), 6 . 70 ( d , d , 1h , j = 15 . 4 , 10 . 8 , ch ═ ch — ch ═ ch ), 6 . 76 ( d , 1h , j = 15 . 4 ch ═ ch — ch ═ ch ), 6 . 99 ( d , 1h j = 1 . 6 , ar - 7h ), 6 . 78 ( d , 1h j = 8 . 1 , ar - 10h ), 6 . 91 ( d , d , 1h j = 1 . 5 , 8 . 0 ar - 11h ), 5 . 98 ( s , 2h , o — ch 2 — o ), 4 . 12 ( t , 2h , och 2 j = 6 . 7 ) 1 . 69 ( m , 2h , ch 2 j = 7 . 3 ) 0 . 97 ( t , 3h , ch 3 j = 7 . 4 ) [ 0257 ] 13 c - nmr ( cdcl 3 ): 10 . 9 ( ch 3 ), 22 . 5 ( ch 2 ), 66 . 3 ( ch 2 ), 101 . 8 ( ch 2 ), 106 . 2 ( ch ) 108 . 9 ( ch ), 120 . 9 ( ch ), 123 . 3 ( ch ) 124 . 9 ( ch ), 131 . 0 ( ch ), 140 . 5 ( ch ), 145 . 1 ( ch ), 148 . 7 ( c ), 148 . 9 ( c ), 167 . 7 ( c ) ms m / z (%): 260 ( m + 59 ), 201 ( 26 ), 174 ( 18 ), 173 ( 100 ), 172 ( 39 ), 171 ( 14 ) 143 ( 34 ), 116 ( 16 ), 115 ( 73 ), 100 ( 12 ) [ 0260 ] 6 avijit banerjee , tapasree ghosal , and aditi kacharya . ( 1984 ). indian journal of chemistry , 23b , 546 - 549 . [ 0262 ] 1 h - nmr ( cdcl 3 ) δ : 5 . 94 ( d , 1h , j = 15 . 2 , ch ═ ch — ch ═ ch ), 7 . 40 ( d , d , 1h , j = 10 . 7 , 15 . 3 , ch ═ ch — ch ═ ch ), 6 . 70 ( d , d , 1h , j = 15 . 4 , 10 . 8 , ch ═ ch — ch ═ ch ), 6 . 76 ( d , 1h , j = 15 . 4 ch ═ ch — ch ═ ch ), 6 . 99 ( d , 1h j = 1 . 6 , ar - 7h ), 6 . 78 ( d , 1h j = 8 . 0 , ar - 10h ), 6 . 91 ( d , d , 1h j = 1 . 5 , 8 . 0 ar - 11h ), 5 . 98 ( s , 2h , o — ch 2 — o ), 4 . 12 ( t , 2h , och 2 j = 6 . 7 ) 1 . 69 ( m , 2h , ch 2 j = 7 . 3 ) 1 . 69 ( m , 2h , ch 2 j = 7 . 6 ), 0 . 95 ( t , 3h , ch 3 j = 7 . 5 ) ms m / z (%): 274 ( m + 50 ), 201 ( 15 ), 174 ( 14 ), 173 ( 100 ), 172 ( 30 ), 171 ( 14 ) 143 ( 21 ), 115 ( 55 ) these 3 , 4 - methylenedioxycinnamide derivatives were synthesised as described in section 2 . 2 , but using 3 , 4 - methylenedioxycinnamic acid ( 500 mg ) as the starting acid and reducing the proportion of triethylamine to 1 . 5 equivalent with respect to the starting acid . also , in the first stage , the reaction mixture was stirred for 2 hours , instead of 30 minutes , again at 0 ° c . [ 0268 ] 1 h - nmr ( cdcl 3 ) δ : 7 . 56 ( d , 1h , j = 15 . 3 , ch ═ ch ), 6 . 73 ( d , 1h , j = 15 . 3 , ch ═ ch —), 7 . 03 ( d , 1h j = 1 . 5 , ar - 7h ), 6 . 79 ( d , 1h , j = 8 . 0 , ar - 8h ), 6 . 99 ( d , d , 1h j = 1 . 6 , 8 . 0 ar - 9h ), 5 . 98 ( s , 2h , o — ch 2 — o ), 3 . 57 ( br , 2h , ch 2 — n — ch 2 ), 3 . 65 ( br , 2h , ch 2 — n — ch 2 ( piperidine )), 1 . 65 ( m , 6h , ch 2 — ch 2 — ch 2 -( piperidine )) [ 0269 ] 13 c - nmr ( cdcl 3 ): 24 . 8 ( ch 2 ), 25 . 6 ( ch 2 ), 26 . 7 ( ch 2 ), 43 . 3 ( ch 2 ), 46 . 9 ( ch 2 ), 101 . 3 ( ch 2 ), 106 . 7 ( ch ), 108 . 4 ( ch ), 115 . 6 ( ch ), 123 . 5 ( ch ), 129 . 9 ( c ), 141 . 9 ( ch ) 148 . 1 ( ch ), 148 . 8 ( c ), 165 . 4 ( c ) [ 0272 ] 1 h - nmr ( cdcl 3 ) δ : 7 . 60 ( d , 1h , j = 15 . 2 , ch ═ ch ), 6 . 73 ( d , 1h , j = 15 . 3 , ch ═ ch —), 7 . 04 ( d , 1h j = 1 . 5 , ar - 7h ), 6 . 80 ( d , 1h j = 8 . 0 , ar - 8h ), 7 . 01 ( d , d , 1h j = 1 . 5 , 8 . 0 ar - 9h ), 5 . 99 ( s , 2h , o — ch 2 — o ), 3 . 61 ( br , 2h , ch 2 — n — ch 2 ( pyrrolidine )), 3 . 57 ( br , 2h , ch 2 — n — ch 2 ( pyrrolidine )), 1 . 99 ( 4h , ch 2 — ch 2 ( pyrrolidine )), [ 0273 ] 13 c - nmr ( cdcl 3 ): 24 . 3 ( ch 2 ), 26 . 1 ( ch 2 ) 46 . 0 ( ch 2 ), 46 . 5 ( ch 2 ), 101 . 4 ( ch 2 ), 106 . 4 ( ch ), 108 . 5 ( ch ), 116 . 8 ( ch ), 123 . 8 ( ch ), 129 . 7 ( c ), 141 . 0 ( ch ) 148 . 1 ( c ), 148 . 9 ( c ), 164 . 8 ( c ) ms m / z (%): 245 ( m + 62 ), 176 ( 41 ) 175 ( 100 ) 145 ( 36 ), 117 ( 11 ), 89 ( 14 ). [ 0277 ] 1 h - nmr ( cdcl 3 ) δ : 7 . 61 ( d , 1h , j = 15 . 3 , ch ═ ch ), 6 . 73 ( d , 1h , j = 15 . 3 , ch ═ ch —), 7 . 03 ( d , 1h j = 1 . 4 , ar - 7h ), 6 . 80 ( d , 1h j = 8 . 0 , ar - 8h ), 7 . 01 ( d , d , 1h j = 1 . 4 , 8 . 0 ar - 9h ), 5 . 99 ( s , 2h , o — ch 2 — o ), 3 . 72 ( br , 4h , ch 2 — n — ch 2 ( morpholine )), 3 . 67 ( br , 4h , ch 2 — o — ch 2 ( morpholine )), [ 0278 ] 13 c - nmr ( cdcl 3 ): 42 . 6 ( ch 2 ), 46 . 2 ( ch 2 ), 66 . 8 ( ch 2 ), 46 . 5 ( ch 2 ), 101 . 4 ( ch 2 ), 106 . 3 ( ch ), 108 . 5 ( ch ), 114 . 4 ( ch ), 123 . 9 ( ch ), 129 . 5 ( ch ), 143 . 0 ( ch ) 148 . 2 ( c ), 148 . 9 ( c ), 149 . 1 ( c ), 165 . 6 ( c ) ms m / z (%): 261 ( m + 60 ), 176 ( 24 ) 175 ( 100 ) 145 ( 30 ), 117 ( 10 ), 89 ( 11 ). to 3 , 4 - methylenedioxycinnamic acid ( 2 g , 0 . 01 mol , 1 eq ) methanol ( 4 ml , 10 eq ) was added . sulphuric acid ( 0 . 2 ml ) was added and refluxed overnight . the solvent was rotary evaporated to yield solid residue . this residue was dissolved in ether and washed with water ( 2 × 100 ml ) and 5 % nahco 3 ( 3 × 100 ml ) and with water ( 2 × 100 ml ). the organic fraction was dried over anhydrous sodium sulphate and rotary evaporated to yield white solid . recrystallisation from ethyl acetate / petroleum spirit yielded crystals ( 69 . 4 % yield ) [ 0285 ] 1 h - nmr ( cdcl 3 ) δ : 7 . 59 ( d , 1h , j = 15 . 9 , ch ═ ch ), 6 . 26 ( d , 1h , j = 15 . 9 , ch ═ ch —), 7 . 03 ( d , 1h j = 1 . 5 , ar - 7h ), 6 . 81 ( d , 1h j = 8 . 0 , ar - 8h ), 7 . 01 ( d , d , 1h j = 1 . 5 , 8 . 0 ar - 9h ), 6 . 00 ( s , 2h , o — ch 2 — o ), 3 . 79 ( s , 3h , och 3 ) [ 0286 ] 13 c - nmr ( cdcl 3 ): δ 1 . 6 ( ch 3 ), 101 . 5 ( t ch 2 ), 106 . 5 ( ch ), 108 . 5 ( ch ), 115 . 7 ( ch ), 124 . 4 ( ch ), 128 . 8 ( ch ), 144 . 5 ( ch ) 148 . 3 ( c ), 148 . 6 ( c ), 148 . 2 ( c ), 167 . 6 ( c ) ms m / z (%): 206 ( m + 100 ), 175 ( 68 ) 175 ( 100 ) 145 ( 27 ), 117 ( 10 ), 89 ( 11 ). [ 0288 ] 7 h . staudinger and h . schneider . ( 1923 ). chem . ber . 56 , 699 . [ 0289 ] 8 takemoto et al . ( 1985 ). chemical and pharmaceutical bulletin 23 , 1161 . piperine ( 2 g , 7 mmol ) was hydrogenated in ethanol ( 50 ml ) over 5 % pd - c under a pressure of hydrogen at 10 psi for 30 mins to give tetrahydropiperine ( 1 . 59 g , 78 % yield ) as an oil 2 . [ 0293 ] 1 h - nmr ( cdcl 3 ) δ : 2 . 55 ( t , 4h , j = 7 . 0 ch 2 — ch 2 — ch 2 ch 2 ), 2 . 32 ( t , 4h , j = 7 . 0 ch 2 . ch 2 . ch 2 ch 2 ) 6 . 66 ( d , 1h j = 1 . 3 , ar - 7h ), 6 . 70 ( d , 1h j = 8 . 0 , ar - 10h ), 6 . 61 ( d , d , 1h j = 1 . 2 , 8 . 0 ar - 11h ), 5 . 89 ( s , 2h , o — ch 2 — o ), 3 . 53 ( t , 2h , n — ch 2 ( piperidine )) 3 . 35 ( t , 2h , n — ch 2 ( piperidine )) 1 . 63 ( m , 2h , ch 2 — ch 2 — ch 2 ( piperidine )) 1 . 54 ( m , 2h , ch 2 — ch 2 — ch 2 ( piperidine )) [ 0294 ] 13 c - nmr ( cdcl 3 ): 24 . 5 ( ch 2 ), 24 . 9 ( ch 2 ), 25 . 5 ( ch 2 ), 26 . 5 ( ch 2 ), 31 . 4 ( ch 2 ), 33 . 2 ( ch 2 ), 35 . 4 ( ch 2 ), 42 . 5 ( ch 2 ), 46 . 6 ( ch 2 ), 100 . 7 ( ch 2 ), 108 . 0 ( ch ), 108 . 8 ( ch ), 109 . 0 ( ch ), 121 . 0 ( c ), 145 . 4 ( c ) 147 . 4 ( c ), 171 . 1 ( c ) ms m / z (%): 289 ( m + 71 ), 204 ( 31 ), 154 ( 23 ), 148 ( 22 ), 141 ( 23 ), 140 ( 38 ), 135 ( 28 ) 127 ( 100 ), 112 ( 23 ), 86 ( 12 ), 84 ( 24 ), 70 ( 10 ), 36 ( 11 ) to 5 -( 3 , 4 - methylenedioxy phenyl )- 2e , 4e - pentadienoic acid cyclohexyl amide ( 300 mg ) was added 5 % pd / c ( 30 mg ) and hydrogenated the contents at 30 psi for 1 hr . the solution was filtered and rotary evaporated to yield a white solid . recrystallisation from ethylacetate and petroleum spirit yielded pure white crystals ( 255 mg , yield 84 %). m . p . 145 . 4 ° c .- 146 . 3 ° c . to 7 -( 3 , 4 - methylenedioxy phenyl )- 2e , 4e , 6e - heptatrienoic acid piperidine amide ( 150 mg , 0 . 06 mmole ) was added 5 % pd / c ( 15 mg ) and hydrogenated the contents at 30 psi for 30 min to give 7 -( 3 , 4 - methylenedioxy phenyl )- heptanoic acid piperidine amide as an oil . [ 0300 ] 1 h - nmr ( cdcl 3 ) δ : 6 . 65 ( d , 1h j = 1 . 6 , ar - 7 - h ), 6 . 71 ( d , 1h j = 7 . 8 , ar - 10 - h ), 6 . 60 ( d , d , 1h j = 1 . 6 , 8 . 0 ar - 11 - h ), 5 . 90 ( s , 2h , o — ch 2 — o ), 5 . 43 ( s , 1h , nh ), 2 . 53 ( t , 2h , j = 7 . 7 ( ch 2 — ch 2 ch 2 ch 2 )) 2 . 14 ( t , 2h , j = 7 . 7 (( ch 2 ch 2 ch 2 ch 2 )) 1 . 62 - 1 . 91 ( m , 10h , ch 2 — ch 2 — ch 2 — ch 2 , ch 2 — ch 2 — ch 2 ( cyclohexyl amide ) 1 . 07 - 1 . 30 ( m , 4h , ch 2 — chch 2 ( cyclohexylamide )) [ 0301 ] 13 c - nmr ( cdcl 3 ): 25 . 3 (( ch 2 ) 2 ), 25 . 7 ( ch 2 ), 25 . 9 ( ch 2 ), 31 . 3 ( ch 2 ), 31 . 7 ( ch 2 ), 33 . 6 ( ch 2 ), 35 . 8 ( ch 2 ), 37 . 3 ( ch 2 ), 48 . 4 ( ch ), 101 . 1 ( ch 2 ), 108 . 4 ( ch ), 109 . 2 ( ch ), 121 . 4 ( ch ), 136 . 4 ( c ), 145 . 8 ( c ), 147 . 8 ( c ), 172 . 2 ( c ), ms m / z (%): 303 ( m + 98 ), 204 ( 72 ), 176 ( 13 ), 168 ( 16 ), 162 ( 12 ) 161 ( 14 ), 154 ( 27 ), 148 ( 66 ), 141 ( 61 ) 135 ( 100 ) 74 ( 24 ) 60 ( 60 ) [ 0303 ] 1 h - nmr ( cdcl 3 ) δ : 6 . 66 ( d , 1h j = 1 . 5 , ar - 7 - h ), 6 . 71 ( d , 1h j = 7 . 8 , ar - 10 - h ), 6 . 60 ( d , d , 1h j = 1 . 6 , 8 . 0 ar - 11 - h ), 5 . 90 ( s , 2h , o — ch 2 — o ), 3 . 53 ( t , 2h , j = 5 . 4 ch 2 n . ch 2 ) 3 . 37 ( t , 2h , j = 5 . 7 , ( ch 2 — n — ch 2 ) 2 . 51 ( t , 2h , j = 7 . 7 ( ch 2 — ch 2 — ch 2 ch 2 — ch 2 — ch 2 )) 2 . 33 ( t , 2h , j = 7 . 7 (( ch 2 — ch 2 — ch 2 — ch 2 — ch 2 ch 2 )) 1 . 52 - 1 . 65 ( m , 10h , hydrocarbon ch 2 , ch 2 , ch 2 — ch 2 — ch 2 ( piperidine )) 1 . 34 ( m , 4h , ch 2 ch 2 ) [ 0304 ] 13 c - nmr ( cdcl 3 ): 24 . 9 ( ch 2 ), 25 . 8 ( ch 2 ), 25 . 9 ( ch 2 ), 26 . 9 ( ch 2 ), 29 . 3 ( ch 2 ), 29 . 7 ( ch 2 ), 31 . 3 ( ch 2 ), 31 . 9 ( ch 2 ), 33 . 8 ( ch 2 ), 42 . 9 ( ch 2 ), 47 . 1 ( ch 2 ), 101 . 8 ( ch 2 ), 108 . 4 ( ch ), 109 . 2 ( ch ), 121 . 4 ( ch ), 137 . 0 ( c ), 145 . 7 ( c ), 147 . 8 ( c ), 171 . 8 ( c ), ms m / z (%): 317 ( m + 78 ), 232 ( 11 ), 204 ( 10 ), 183 ( 30 ), 182 ( 15 ), 154 ( 21 ) 148 ( 43 ), 141 ( 41 ), 127 ( 100 ), 112 ( 43 ), 85 ( 49 ) yield 51 . 2 % 3 - benzo - 1 , 3 - dioxol - 5 - ylacrylic acid ( 2 g ) was hydrogenated in ethanol ( 50 ml ) over 5 % pd - c under a pressure of hydrogen at 10 psi for 40 mins to give 3 - benzo - 1 , 3 - dioxol - 5 - ylpropionic acid ( 1 . 67 g , 80 % yield ) as a solid , m . p . 86 . 1 °- 88 . 3 ° c . ( lit m . p . 87 - 88 ° c .) 10 the method was adapted from that reported for piperlonguminine ( section 2 . 2 ) but utilising 3 - benzo - 1 , 3 - dioxol - 5 - ylpropionic acid and piperidine as the acid and amine components respectively . a mixture of 3 - benzo - 1 , 3 - dioxol - 5 - ylpropionic acid ( 200 mg , 0 . 0026 mole , 1 eq ) and triethylamine ( 0 . 27 ml , 0 . 002 mole , 2 eq ) in dichloromethane ( 50 ml ) was stirred for 15 min at 0 ° c . to this mixture methanesulfonyl chloride ( 0 . 11 ml , 0 . 0015 mole , 1 . 5 eq ) was added and stirred for further 30 min at 0 ° c . piperidine ( 0 . 15 ml , 0 . 0015 mole , 1 . 5 eq ) was added to the mixture and stirred for 1 h at 0 ° c . and 1 h at room temperature . dichloromethane ( 50 ml ) was added to the mixture which was then washed with 5 % hcl ( 3 × 100 ml ), saturated aqueous nahco 3 ( 3 × 100 ml ) and water ( 3 × 100 ml ). the organic fraction was dried over anhydrous sodium sulphate , filtered and rotary evaporated to yield brown oil ( 65 % yield ). [ 0312 ] 1 h - nmr ( cdcl 3 ) δ : 2 . 87 ( t , 2h , j = 7 . 3 ch 2 ), 2 . 57 ( t , 2h , j = 7 . 0 ch 2 — ch 2 ) 6 . 70 ( d , 1h j = 1 . 5 , ar - 7h ), 6 . 72 ( d , 1h j = 8 . 0 , ar - 10h ), 6 . 66 ( d , d , 1h j = 1 . 2 , 8 . 0 ar - 11h ), 5 . 90 ( s , 2h , o — ch 2 — o ), 3 . 55 ( t , 2h , n — ch 2 -( piperidine )) 3 . 34 ( t , 2h , n — ch 2 -( piperidine )) 1 . 62 ( m , 2h , ch 2 — ch 2 — ch 2 -( piperidine )) 1 . 49 ( m , 2h , ch 2 — ch 2 — ch 2 ( piperidine )) [ 0313 ] 13 c - nmr ( cdcl 3 ): 25 . 7 ( ch 2 ), 25 . 9 ( ch 2 ), 26 . 6 ( ch 2 ), 31 . 7 ( ch 2 ), 35 . 8 ( ch 2 ), 43 . 1 ( ch 2 ), 47 . 1 ( ch 2 ), 101 . 2 ( ch 2 ), 109 . 2 ( ch ), 109 . 3 ( ch ), 121 . 5 ( ch ), 135 . 6 ( c ), 146 . 2 ( c ) 148 . 0 ( c ), 170 . 8 ( c ) [ 0314 ] 9 biswanath das ., a . kasinatham ., and p . madhusudhan . ( 1998 ). regioselective reduction of αβ - double bond of some naturally occuring dienamides using nabh 4 / i 2 system . tetrahedron letters 39 , 677 - 678 . [ 0315 ] 10 perkin , robinson , ( 1907 ) journal of chemical society 91 , 1084 a mixture of monomethoxycinnamic acid ( 200 mg , 0 . 89 mmol , 1 eq ) and triethylamine ( 2 . 4 ml , 1 . 78 mmol , 2 eq ) in dichloromethane ( 50 ml ) was stirred for 15 min at 0 ° c . to this mixture methanesulfonyl chloride ( 1 . 02 ml , 1 . 33 mmol , 1 . 5 eq ) was added and stirred for further 30 min at 0 ° c . piperidine ( 0 . 23 ml , 1 . 33 mmol , 1 . 5 eq ) was added to the mixture and stirred for 1 h at 0 ° c . and 1 h at room temperature . then dichloromethane ( 50 ml ) was added to the mixture , which was then washed with 5 % hcl ( 3 × 100 ml ), saturated aqueous nahco 3 ( 3 × 100 ml ) and water ( 3 × 100 ml ). the organic fraction was dried over anhydrous sodium sulphate , filtered and rotary evaporated to yield an oil . this oil was purified by chromatography on silica gel using ethyl acetate / petroleum spirit ( 2 : 8 ) as an eluant . the piperidine amide of 3 , 4 dimethoxycinnamic acid was prepared in the same way utilising 200 mg of the acid . [ 0320 ] 1 h - nmr ( cdcl 3 ) δ : 7 . 56 ( d , 1h , ch ═ ch ), 7 . 29 ( d , 1h , j = 7 . 8 arh ), 7 . 12 ( d , 1h , j = 7 . 6 arh ) 7 . 0 ( d , d 1h , j = 1 . 8 arh ) 6 . 86 - 6 . 90 ( m , arh ), 6 . 88 ( d , 1h , j = 15 . 4 ch ═ ch ), 3 . 583 . 66 ( br , 4h , ch 2 — n — ch 2 -( piperidine )) 1 . 56 - 1 . 71 ( m , 6h , ch 2 — ch 2 — ch 2 ( piperidine )) 3 . 83 ( s , 3h , och 3 ) [ 0321 ] 13 c - nmr ( cdcl 3 ): 25 . 7 ( ch 2 ), 26 . 0 ( ch 2 ), 27 . 1 ( ch 2 ), 43 . 7 ( ch 2 ), 47 . 4 ( ch 2 ), 55 . 7 ( ch 3 ), 113 . 4 ( ch ), 115 . 3 ( ch ), 118 . 5 ( ch ), 120 . 6 ( ch ), 130 . 1 ( ch ), 142 . 4 ( ch ), 137 . 3 ( c ), 160 . 2 ( c ), 165 . 6 ( c ) ms m / z (%): 245 ( m + 28 ), 162 ( 22 ), 161 ( 100 ), 133 ( 20 ), 118 ( 24 ), 113 ( 14 ), 84 ( 51 ) yield 25 . 5 % [ 0323 ] 1 h - nmr ( cdcl 3 ) δ : 7 . 60 ( d , 1h , j = 15 . 4 , ch ═ ch ), 7 . 29 ( d , 1h , j = 7 . 8 arh ), 7 . 12 ( d , 1h , j = 7 . 6 arh ) 7 . 0 ( d , d 1h , j = 1 . 8 arh ) 6 . 86 - 6 . 90 ( m , arh ), 6 . 88 ( d , 1h , j = 15 . 4 ch ═ ch ), 3 . 58 - 3 . 66 ( br , 4h , ch 2 — n — ch 2 ( piperidine )) 1 . 56 - 1 . 71 ( m , 6h , ch 2 — ch 2 — ch 2 -( piperidine )) 3 . 83 ( s , 3h , och 3 ) [ 0324 ] 13 c - nmr ( cdcl 3 ): 25 . 7 ( ch 2 ), 26 . 0 ( ch 2 ), 27 . 1 ( ch 2 ), 43 . 7 ( ch 2 ), 47 . 4 ( ch 2 ), 55 . 7 ( ch 3 ), 113 . 4 ( ch ), 115 . 3 ( ch ), 118 . 5 ( ch ), 120 . 6 ( ch ), 130 . 1 ( ch ), 142 . 4 ( ch ), 137 . 3 ( c ), 160 . 2 ( c ), 165 . 6 ( c ) ms m / z (%): 245 ( m + 77 ), 162 ( 65 ), 161 ( 100 ), 133 ( 20 ), 118 ( 24 ), 113 ( 14 ), 84 ( 51 ) [ 0328 ] 1 h - nmr ( cdcl 3 ) δ : 7 . 61 ( d , 1h , j = 15 . 4 , ch ═ ch ), 7 . 47 ( d , 2h , j = 7 . 8 arh ), 6 . 87 - 6 . 90 ( m , 2h , arh ), 6 . 77 ( d , 1h , j = 15 . 4 ch ═ ch ), 3 . 58 - 3 . 65 ( br , 4h , ch 2 — n — ch 2 ( piperidine )) 1 . 52 - 1 . 69 ( m , 6h , ch 2 ch 2 ch 2 ( piperidine )) 3 . 82 ( s , 3h , och 3 ) [ 0329 ] 13 c - nmr ( cdcl 3 ): 25 . 6 ( ch 2 ), 26 . 0 ( ch 2 ), 26 . 4 ( ch 2 ), 43 . 7 ( ch 2 ), 47 . 4 ( ch 2 ), 55 . 7 ( ch 3 ), 114 . 5 ( ch ), 115 . 6 ( ch ), 118 . 5 ( ch ), 121 . 9 ( ch ), 129 . 6 ( ch ), 142 . 2 ( ch ), 132 . 8 ( c ), 161 . 0 ( c ), 166 . 0 ( c ) ms m / z (%): 245 ( m + 71 ), 162 ( 17 ), 161 ( 100 ), 133 ( 26 ), 118 ( 12 ), 113 ( 14 ), 84 ( 24 ), 77 ( 36 ) [ 0332 ] 1 h - nmr ( cdcl 3 ) 60 mhz δ : 7 . 61 ( 1h , ch ═ ch ), 7 . 23 ( 1h , arh ), 6 . 98 ( 1h , arh ) 6 . 82 ( 1h , j = 1 . 8 arh ) 6 . 68 ( 1h , ch ═ ch ), 3 . 58 - 3 . 65 ( br , 4h , ch 2 — n — ch 2 ( piperidine )) 1 . 5 - 1 . 8 ( 6h , ch 2 ch 2 ch 2 ( piperidine )) 3 . 91 ( s , 6h , och 3 ) 2 ) ms m / z (%): 275 ( m + 62 ), 192 ( 48 ), 191 ( 100 ), 161 ( 18 ), 118 ( 11 ), 84 ( 26 ), 77 ( 12 ), yield 42 . 3 %

US-63090103-A

a suction device for cleaning skin having a suction nozzle with a plurality of openings that are covered by an elastic diaphragm which is drawn into the openings by a pulsating drive force so that the diaphragm forms a plurality of pulsating secondary vacuum pumps in contact with the skin , thus , the vacuum action on the skin is divided into short variable suction pulses and the covering elastic diaphragm offers an easily exchangeable disposable hygienic protection .

fig1 illustrates suction pulses as an embodiment example by means of an idealized characteristic line 1 . the propagation of the vacuum wave in the inner skin layers is effected in a continuous manner with respect to time according to a time - dependent fuction , wherein a determined depth can be adjusted in the selected area by changing the pulse parameters described previously . fig2 shows an embodiment of the suction device 2 , in which the suction vacuum of the vacuum pump ( not shown ) first acts on the elastic diaphragm 3 , wherein the diaphragm , which is sucked into the many openings 4a of the suction nozzle 4 , in turn forms an equal number of secondary mini - vacuum pumps 5 which act on the skin 6 and on the skin pores 7 . the diaphragm 3 has a bead edge 3a that sealingly engages in a groove 4b provided in the circumferential surface of the suction nozzle 4 . thus , the diaphragm 3 forms a cap for the suction nozzle 4 . the deposits which are carried from the skin pores 7 to the surface are uniformly distributed on the surface of the skin 6 and the rubber diaphragm 3 in a simple manner and can be removed subsequently with a cleaning cloth . there are zones of normal pressure or slight vacuum pressure between the suction pulses , wherein the diaphragm 3 is tensioned and / or lifted along the suction openings 4a under the influence of inherent elastic forces and / or the pressing force of the air . the skin 6 is relaxed in the meantime and the possible excess quantity of exiting air can escape via lateral ducts or openings ( not shown ) in the rubber diaphragm 3 which are provided for this purpose . the free suction openings 4a not pressed against the skin 6 are closed by the diaphragm 3 so that there is no vacuum loss or only a slight vacuum loss . the suction openings 4a are preferably constructed so as to be cone - shaped or chamber - shaped ( conical chamber 8 , fig3 ) with a cross section which tapers toward the inside , so as to prevent the rubber diaphragm 3 from being pressed into the free openings to an excessive degree , whereas no vacuum pressure can build up at the other openings pressed against the skin 6 . the elastic diaphragm 3 can vary in thickness , preferably having a thickness which increases toward the edge 15 ( fig5 ) and thus ensures a vacuum compensation . as shown in fig7 a , the suction opening 4a can have a cross section which widens toward the interior of the suction nozzle 4 or , as shown in fig7 b , the suction opening can be in the form of a chamber 14 which comprises a through - hole 17 toward the interior of the suction nozzle 4 . fig9 shows the construction of the openings 4a by means of offset grids 18 . the size of the suction openings 4a can vary from one opening to the other ( fig6 ) so as to act in an optimal manner on different pore sizes or skin types . the edge of an opening 4a can have a projecting bead 13 ( fig8 ) which forms a valve with the diaphragm . this valve has the function of an exhaust valve for the excess quantity of exiting air when the diaphragm 3 is relaxed . thus , the object of the exhaust valve is similar to that of the lateral venting ducts described previously . fig3 shows an embodiment having a metallized elastic diaphragm 9 with an electromagnetic drive 10 . the advantages of the magnetic drive consist on the one hand in the independence of the individual secondary mini - vacuum pumps 5 from one another regardless of how many openings 4a are pressed against the skin or remain free along the skin , so that the same vacuum action is always achieved , and on the other hand in the freedom of vibration , since no heavy mechanical parts are moved , as well as in the improved frequency response and the improved configuration possibility of the pulse shape . as an additional advantage , it is also worth noting that the electromagnetic drive is maintenance - free and has a long life compared to an electric motor with bar collector , and the massaging action of the elastic diaphragm on the skin is increased as a result of the fine magnet inserts 9 . fig4 illustrates an embodiment of a device specifically suited for the treatment of individual pimples and blackheads , wherein the narrow suction tube 11 allows aimed placement and makes it possible to build up higher vacuum values . the skin - cleaning action of the suggested technical solution is reinforced by the use of cosmetic compositions , wherein grease substances help to loosen the skin deposits and seal the suction openings placed against the skin . in so doing , a skin - care effect is also achieved in that , on the one hand , a massage is carried out which is gentle and simultaneously penetrates into the skin and stimulates the blood circulation in the skin layers and thus provides for an improved supply of nutrients and moisture to the skin cells . on the other hand , the utilized substances are simultaneously massaged into the deeper skin layers . a combination with steam treatment , as is conventional in cosmetic salons , further increases the cleaning action as is to be expected . while the invention has been illustrated and described as embodied in a suction device for cleaning the skin , it is not intended to be limited to the details shown , since various modifications and structural changes may be made without departing in any way from the spirit of the present invention . without further analysis , the foregoing will so fully reveal the gist of the present invention that others can , by applying current knowledge , readily adapt it for various applications without omitting features that , from the standpoint of prior art , fairly constitute essential characteristics of the generic or specific aspects of this invention . what is claimed as new and desired to be protected by letters patent is set forth in the appended claims .

US-75876991-A

methods and compositions for stimulating the growth of hair are disclosed wherein said compositions include a cyclopentane heptanoic acid , 2 - cycloalkyl or arylalkyl compound represented by the formula i wherein the dashed bonds represent a single or double bond which can be in the cis or trans configuration , a , b , z , x , r 1 and r 2 are as defined in the specification . such compositions are used in treating the skin or scalp of a human or non - human animal . bimatoprost is preferred for this treatment .

alopecia ( baldness ) a deficiency of either normal or abnormal hair , is primarily a cosmetic problem in humans . it is a deficiency of terminal hair , the broad diameter , colored hair that is readily seen . however , in the so - called bald person although there is a noticeable absence of terminal hair , the skin does contain vellus hair which is a fine colorless hair which may require microscopic examination to determine its presence . this vellus hair is a precursor to terminal hair . in accordance with the invention as described herein , compounds represented by wherein r 1 , r 2 , a , b , z and x are defined above , can be used to stimulate , such as stimulating the conversion of vellus hair to growth as terminal hair as well as increasing the rate of growth of terminal hair . in the course of treating patients having glaucoma , treatment may only be appropriate in one eye . within the course of daily practice it was discovered that a patient who been treated with bimatoprost has lashes that were longer , thicker and fuller in the treated eye than in the non - treated eye . on examination the difference was found to be very striking . the lashes were longer and had a more full dense appearance in the treated eye . the lash appearance on the lids of the treated eye would have appeared quite attractive if it represented a bilateral phenomenon . because of its asymmetric nature , the long lashes on one side could be construed as disturbing from a cosmetic standpoint . because of the very unusual appearance a systematic examination of other patients who were taking bimatoprost in only one eye was made . it soon became apparent that this altered appearance was not an isolated finding . comparison of the lids of patients who were taking bimatoprost in only one eye revealed subtle changes in the lashes and adjacent hairs of the bimatoprost - treated side in several patients . definite differences could be identified to varying degrees in the lashes and adjacent hairs of all patients who were taking the drug on a unilateral basis for longer than 6 months . these findings were totally unexpected and surprising . minoxidil is thought to stimulate hair growth by its ability to cause vasodilation suggesting that agents with such a capability may be uniquely effective in stimulating hair growth . the finding that bimatoprost , which , as explained below , is not a prostaglandin derivative , such as latanoprost stimulates hair growth is especially surprising and unexpected . the changes in the lashes were apparent on gross inspection in several patients once attention was focused on the issue . in those with light colored hair and lashes , the differences were only seen easily with the aid of the high magnification and lighting capabilities of the slit lamp biomicroscope . in the course of a glaucoma follow up examination , attention is generally immediately focused on the eye itself . because of the high power magnification needed only one eye is seen at a time and the eye is seen at a high enough power that the lashes are not in focus . at these higher powers , any lash asymmetry between the two eyes is not likely to be noticed except by careful systematic comparison of the lashes and adjacent hairs of the eyelids of the two eyes . observed parameters leading to the conclusion that more robust hair growth occurred in the treated area following administration of bimatroprost were multiple . they included increased length of lashes , increased numbers of lashes along the normal lash line , increased thickness and luster of lashes , increased auxiliary lash - like terminal hair in transitional areas adjacent to areas of normal lash growth , increased lash - like terminal hairs at the medial and lateral canthal area , increased pigmentation of the lashes , increased numbers , increased length , as well as increased luster , and thickness of fine hair on the skin of the adjacent lid , and finally increased perpendicular angulation of lashes and lash - like terminal hairs . the conclusion that hair growth is stimulated by bimatoprost is thus supported not by evidence of a difference in a single parameter but is based on multiple parameters of hair appearance in treated vs . control areas in many subjects . this finding is entirely unexpected and represents a previously unrecognized effect of bimatoprost on stimulation of hair follicles . the modified hairs of the lashes normally turn over slowly and are in their resting phase longer than hair on , for example , the scalp . the ability to cause differences in appearance of lashes , the ability to stimulate conversion of vellus or intermediate hair to terminal hairs in transitional areas and the ability to stimulate growth of vellus hair on the skin indicates that bimatoprost is a diversely effective and efficacious agent for the stimulation of hair growth . thus , the present invention provides a treatment by bimatoprost of hair of the scalp , eyebrows , beard and other areas that contain hair that results in increased hair growth in the corresponding areas . patients that are treated in or around the eye with compounds of the invention , such as bimatoprost , regularly develop hypertrichosis including altered differentiation , numbers , length , thickness , curvature and pigmentation in the region of treatment . some examples of representative compounds useful in the practice of the present invention include the compounds shown in table 1 : one presently preferred compound for use in the practice of the present invention is cyclopentane n - ethyl heptanamide - 5 - cis - 2 -( 3α - hydroxy - 5 - phenyl - 1 - trans - pentenyl )- 3 , 5 - dihydroxy , [ 1 α , 2 β , 3 α , 5 α ], also known as bimatoprost and sold under the name of lumigan ® by allergan , inc ., california , usa . this compound has the following structure : the synthesis of the above compounds described above has been disclosed in u . s . pat . no . 5 , 607 , 978 . this patent also shows , particularly in examples 1 , 2 , 5 and 7 that these compounds are not prostaglandins , in that they do not behave as prostaglandins in art - recognized assays for prostaglandin activity . the invention thus relates to the use of the above compounds , or prodrugs of the active compounds , for treatment for the stimulation of hair growth . as used herein , hair growth includes hair associated with the scalp , eyebrows , eyelids , beard , and other areas of the skin of animals . in accordance with one aspect of the invention , the compound is mixed with a dermatologically compatible vehicle or carrier . the vehicle which may be employed for preparing compositions of this invention may comprise , for example , aqueous solutions such as e . g ., physiological salines , oil solutions or ointments . the vehicle furthermore may contain dermatologically compatible preservatives such as e . g ., benzalkonium chloride , surfactants like e . g ., polysorbate 80 , liposomes or polymers , for example , methyl cellulose , polyvinyl alcohol , polyvinyl pyrrolidone and hyaluronic acid ; these may be used for increasing the viscosity . furthermore , it is also possible to use soluble or insoluble drug inserts when the drug is to be administered . the invention is also related to dermatological compositions for topical treatment for the stimulation of hair growth which comprise an effective hair growth stimulating amount of one or more compounds as defined above and a dermatologically compatible carrier . effective amounts of the active compounds may be determined by one of ordinary skill in the art but will vary depending on the compound employed , frequency of application and desired result , and the compound will generally range from about 0 . 0000001 to about 50 %, by weight , of the dermatological composition , preferably from about 0 . 001 to about 50 %, by weight , of total dermatological composition , more preferably from about 0 . 1 to about 30 %, by weight of the composition . the present invention finds application in all mammalian species , including both humans and animals . in humans , the compounds of the subject invention can be applied for example , to the scalp , face , beard , head , pubic area , upper lip , eyebrows , and eyelids . in animals raised for their pelts , e . g ., mink , the compounds can be applied over the entire surface of the body to improve the overall pelt for commercial reasons . the process can also be used for cosmetic reasons in animals , e . g ., applied to the skin of dogs and cats having bald patches due to mange or other diseases causing a degree of alopecia . the pharmaceutical compositions contemplated by this invention include pharmaceutical compositions suited for topical and local action . the term “ topical ” as employed herein relates to the use of a compound , as described herein , incorporated in a suitable pharmaceutical carrier , and applied at the site of thinning hair or baldness for exertion of local action . accordingly , such topical compositions include those pharmaceutical forms in which the compound is applied externally by direct contact with the skin surface to be treated . conventional pharmaceutical forms for this purpose include ointments , liniments , creams , shampoos , lotions , pastes , jellies , sprays , aerosols , and the like , and may be applied in patches or impregnated dressings depending on the part of the body to be treated . the term “ ointment ” embraces formulations ( including creams ) having oleaginous , water - soluble and emulsion - type bases , e . g ., petrolatum , lanolin , polyethylene glycols , as well as mixtures of these . typically , the compounds are applied repeatedly for a sustained period of time topically on the part of the body to be treated , for example , the eyelids , eyebrows , skin or scalp . the preferred dosage regimen will generally involve regular , such as daily , administration for a period of treatment of at least one month , more preferably at least three months , and most preferably at least six months . for topical use on the eyelids or eyebrows , the active compounds can be formulated in aqueous solutions , creams , ointments or oils exhibiting physiologically acceptable osmolarity by addition of pharmacologically acceptable buffers and salts . such formulations may or may not , depending on the dispenser , contain preservatives such as benzalkonium chloride , chlorhexidine , chlorobutanol , parahydroxybenzoic acids and phenylmercuric salts such as nitrate , chloride , acetate , and borate , or antioxidants , as well as additives like edta , sorbitol , boric acid etc . as additives . furthermore , particularly aqueous solutions may contain viscosity increasing agents such as polysaccharides , e . g ., methylcellulose , mucopolysaccharides , e . g ., hyaluronic acid and chondroitin sulfate , or polyalcohol , e . g ., polyvinylalcohol . various slow releasing gels and matrices may also be employed as well as soluble and insoluble ocular inserts , for instance , based on substances forming in - situ gels . depending on the actual formulation and compound to be used , various amounts of the drug and different dose regimens may be employed . typically , the daily amount of compound for treatment of the eyelid may be about 0 . 1 ng to about 100 mg per eyelid . for topical use on the skin and the scalp , the compound can be advantageously formulated using ointments , creams , liniments or patches as a carrier of the active ingredient . also , these formulations may or may not contain preservatives , depending on the dispenser and nature of use . such preservatives include those mentioned above , and methyl -, propyl -, or butyl - parahydroxybenzoic acid , betain , chlorhexidine , benzalkonium chloride , and the like . various matrices for slow release delivery may also be used . typically , the dose to be applied on the scalp is in the range of about 0 . 1 ng to about 100 mg per day , more preferably about 1 ng to about 10 mg per day , and most preferably about 10 ng to about 1 mg per day depending on the compound and the formulation . to achieve the daily amount of medication depending on the formulation , the compound may be administered once or several times daily with or without antioxidants . a study is initiated to systematically evaluate the appearance of lashes and hair around the eyes of patients who are administering bimatoprost in only one eye . the study involves 10 subjects , 5 male , 5 female , average age 70 years , ( ranging from 50 - 94 years ). all patients have glaucoma . each subject is treated daily by the topical application of one drop of bimatoprost at a dosage of 1 . 5 . mu . g / ml / eye / day ( 0 . 03 %, by weight , ophthalmic solution , sold under the name lumigan ® by allergan , irvine , calif ., u . s . a .) to the region of one eye by instilling the drop onto the surface of the eye . the region of the fellow control eye is not treated with bimatoprost and served as a control . in the course of treatment with eye drops , there is typically spontaneous tearing , and excess fluid from the drops and associated tears gathers at the lid margins . in the course of wiping the drug containing fluid from the lid margins and adjacent lid , a thin film of the fluid is routinely spread to contact the adjacent skin of the lid area . this widespread exposure of the skin around the lid to the effect of drops is regularly demonstrated in patients who develop a contact dermatitis . typically the entire area of the upper and lower lid are involved with induration , erythema and edema demonstrating the regular extensive exposure of the ocular adnexa to the influence of topically applied drugs . the study is limited to subjects who have administered bimatoprost to one eye for more than 3 months . the mean duration of exposure to bimatoprost prior to assessing the parameter of lash growth between the control and study eye is 129 days ( range 90 - 254 days ). observations are made under high magnification at the slit lamp biomicroscope . documentation of differences between the control and treatment areas is accomplished using a camera specially adapted for use with the slit lamp biomicroscope . length of lashes : increased length of eyelashes is regularly observed on the side treated with bimatoprost . the difference in length varies from approximately 10 % to as much as 30 %. number of lashes : increased numbers of lashes are observed in the treated eye of each patient . in areas where there are a large number of lashes in the control eye , the increased number of lashes in the bimatoprost - treated eye gave the lashes on the treated side a more thickly matted overall appearance . auxiliary lash - like hair growth : several patients have an apparent increase in lash - like hair in transitional areas adjacent to areas of normal lash distribution . these prominent robust appear lash - like hairs appeared to be of comparable length to the actual lashes . these long , thick lash - like hairs were present in the central portion of the lids of several patients in a linear arrangement just above the lash line . hairs are present at similar locations in the control eyes but are by contrast thinner or more fine in appearance , have less luster and pigment and are more flat against the skin of the lid typical of vellus or intermediate hairs . in several patients , lash - like terminal hairs grow luxuriantly in the medial canthal area in the treated eye . in the corresponding control eye , vellus hairs are seen at the same location . lash - like hairs are also present in the lateral canthal area of the treated eye but not the control eye in several subjects . large lashes are not normally present at the lateral canthus and the area is generally free of all but a few occasional very fine lashes or vellus hairs . increased growth of vellus hair on lids : fine microscopic vellus hair is present on the skin of the lids and is easily seen with the slit lamp biomicroscope . this vellus hair is typically denser adjacent to and below the lateral portion of the lower lids . while remaining microscopic , vellus hairs are increased in number , appear more robust and are much longer and thicker in treated than in control eyes in the areas below and lateral to the lower lid . perpendicular angulation of hairs : in areas where there are lash - like hairs above the lash line and in the medial and lateral canthal areas , the hairs are much longer , thicker and heavier . they also leave the surface of the skin at a more acute angle , as though they are stiffer or held in a more erect position by more robust follicles . this greater incline , pitch , rise or perpendicular angulation from the skin surface gives the appearance of greater density of the hairs . the foregoing observations clearly establish that bimatoprost can be used to increase the growth of hair in man . this conclusion is based on the regular and consistent finding of manifestations of increased hair growth in treated vs . control areas in human subjects . the conclusion that the drug bimatoprost is capable of inducing increased robust growth of hair is based not on a single parameter , i . e ., length , but is based on multiple lines of evidence as described in the results . detailed examination and description of multiple parameters of differences in hair is greatly facilitated by the ability to examine the hairs at high magnification under stable conditions of fixed focal length and subject position utilizing the capabilities of the slitlamp biomicroscope . the figure shows the actual results on the eyelashes of a patient treated for glaucoma with lumigan ® bimatoprost for 6 months . a topical cream is prepared as follows : tegacid and spermaceti are melted together at a temperature of 70 - 80 ° c . methylparaben is dissolved in about 500 gm of water and propylene glycol , polysorbate 80 , and bimatoprost are added in turn , maintaining a temperature of 75 - 80 ° c . the methylparaben mixture is added slowly to the tegacid and spermaceti melt , with constant stirring . the addition is continued for at least 30 minutes with additional stirring until the temperature has dropped to 40 - 45 ° c . finally , sufficient water is added to bring the final weight to 1000 gm and the preparation stirred to maintain homogeneity until cooled and congealed . a topical cream is prepared as follows : tegacid and spermaceti are melted together at a temperature of 70 - 80 ° c . methylparaben is dissolved in water and propylene glycol , polysorbate 80 , and bimatoprost are added in turn , maintaining a temperature of 75 - 80 ° c . the methylparaben mixture is added slowly to the tegacid and spermaceti melt , with constant stirring . the addition is continued for at least 30 minutes with additional stirring until the temperature has dropped to 40 - 45 ° c . finally , sufficient water is added to bring the final weight to 1000 gm and the preparation stirred to maintain homogeneity until cooled and congealed . the composition is applied to bald human scalp once daily to stimulate the growth of hair . an ointment containing 2 % by weight bimatoprost is prepared as follows : white petrolatum and wool fat are melted , strained and liquid petrolatum is added thereto . the bimatoprost , zinc oxide , and calamine are added to the remaining liquid petrolatum and the mixture milled until the powders are finely divided and uniformly dispersed . the mixture is stirred into the white petrolatum , melted and cooled with stirring until the ointment congeals . the foregoing ointment can be applied topically to mammalian skin for increased rate of hair growth , and can be prepared by omitting the zinc oxide and calamine . a dermatological ophthalmic ointment containing 10 % by weight bimatoprost is prepared by adding the active compound to light liquid petrolatum . white petrolatum is melted together with wool fat , strained , and the temperature adjusted to 45 - 50 ° c . the liquid petrolatum slurry is added and the ointment stirred until congealed . suitably the ointment is packaged in 30 gm tubes . the foregoing ointment can be applied to the eyelid to enhance the growth of eyelashes . similarly the composition can be applied to the brow for eyebrow growth . an aqueous solution containing 5 %, by weight , bimatoprost is prepared as follows . bimatoprost is dissolved in water and the resulting solution is sterilized by filtration . the solution is aseptically filled into sterile containers . the composition so prepared can be used in the topical treatment of baldness by application to the scalp daily . a sample of bimatoprost is dissolved in the vehicle of n - methylpyrrolidone and propylene glycol . the composition can be used for application to dogs or cats having hair loss due to mange or alopecia of other causes . an aerosol containing approximately 0 . 1 % by weight bimatoprost is prepared by dissolving the bimatoprost in absolute alcohol . the resulting solution filtered to remove particles and lint . this solution is chilled to about minus 30 ° c . to the solution is added a chilled mixture of dichlorodifluoromethane and dichlorotetrafluoroethane . thirteen ml plastic - coated amber bottles are cold filled with 11 . 5 gm each of the resulting solution and capped . the composition can be sprayed on the scalp daily to stimulate the growth of hair . a powder of the compound bimatoprost is prepared by mixing in dry form with talcum powder at a weight / weight ratio of 1 : 10 . the powdered mixture is dusted on the fur of minks or other commercially valuable fur bearing animals and show animals for increased rate of hair growth . following the procedure of the preceding examples , compositions are similarly prepared substituting an equimolar amount of a compound of table 1 for the bimatoprost disclosed in the preceding examples . similar results are obtained . while the preferred embodiment of the invention has been illustrated and described , it will be appreciated that various changes can be made therein without departing from the spirit and scope of the invention . the embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows :

US-201213441783-A

an implantable medical device such as a cardiac pacemaker or implantable cardioverter / defibrillator with the capability of storing body temperature measurements taken periodically and / or when triggered by particular events .

fig1 shows a system diagram of an implantable medical device , in this case is a microprocessor - based pacemaker with defibrillation and / or antitachycardia pacing capability that incorporates the present invention . a microprocessor controller 10 communicates with a system memory 12 via a bidirectional system bus . memory 12 may typically comprise a rom for program storage and a ram for data storage . the overall operation of the device is controlled by a system program running from the memory 12 . the microprocessor also has a port for communicating with the telemetry interface 40 which in turn receives programming data from and transmits telemetry data to an external programmer 70 by a radio or other data link . the pacemaker has atrial sensing and pacing channels comprising electrode 34 , lead 33 , sensing amplifier 31 , pulse generator 32 , and an atrial channel interface 30 which communicates bidirectionally with a port of microprocessor 10 . the ventricular sensing and pacing channels similarly comprise electrode 24 , lead 23 , sensing amplifier 21 , pulse generator 22 , and a ventricular channel interface 20 . for each channel , the same lead and electrode are used for both sensing and pacing . the channel interfaces include sampling circuitry and an analog - to - digital converter for digitizing sensing signal outputs from the sensing amplifiers and registers which can be written to by the microprocessor in order to control pacing . an exertion level sensor 90 is also provided for rate - adaptive pacing . the exertion level sensor may measure , for example , respiratory rate , minute ventilation , or body activity with an accelerometer . a shock pulse generator 80 is also interfaced to the microprocessor for delivering defibrillation pulses to the heart via a separate pair of electrodes 81 a and 81 b . a temperature sensor 50 communicates with the microprocessor via a sensor interface 51 . the sensor 50 may be a resistive temperature detector driven by a current source that converts temperature changes in the patient &# 39 ; s body into electrical signals . the sensor 50 may be incorporated into an external lead ( e . g ., an intravenous lead ) or may be internal to the housing of the device . an example of such an internal sensor is described more fully below . the sensor interface 51 includes sampling circuitry for sampling the sensor output and an analog - to - digital converter for digitizing the samples that are then processed and stored by the microprocessor . in accordance with the invention , the controller 10 is configured to store temperature measurements collected at specified regular intervals and / or collected when triggered by sensed events or initiation of particular device activity . for example , temperature measurements may be collected and stored at specified times on a daily basis with an associated time stamp . other physiological measurements may also be simultaneously collected and associated with a temperature measurement , including measurements of heart rate , respiratory rate , minute ventilation , or body activity . a temperature measurement may also be triggered by other sensor activity such as when a measured exertion level measurement reaches a specified limit value or upon detection of a specified cardiac rhythm . one use of periodic temperature measurements is to calculate a trend from the measurements indicating temperature changes over a specified period of time . the device can also be programmed to enable trending for a combination of heart rate , accelerometer measurements , respiratory rate , temperature , or other such inputs . besides varying which inputs to trend , and the trending rate ( e . g . fast / slow ) can also be selectively varied , and each of the trended inputs could be sampled at an independent rate . for example , the heart rate could be sampled once every 16 seconds while the temperature is only sampled once every 15 minutes . the fast trending rate for the temperature could be once every 15 minutes and the slow trending rate could be once every hour . this trending data could then be read from the device on a daily or weekly interval depending on the trending rate . another option is to gather trending information around some critical point in time . for example trending data could be gathered only around cardiac events or around patient activated times . even if trending is not programmed , the basal temperature can still be recorded on a daily basis . this can be done by measuring the temperature at set time ( e . g . 3 am ) or after the patient activity is at a minimum ( e . g . 2 hours at lower rate limit ). this basal temperature data could be kept for the last 30 days or other specified time period . temperature sensors can drift over time due to component drift or such things as flicker noise . for example , when a pg is first calibrated it may read 98 . 8 deg as 98 . 7 degrees , and over time the error will vary . over the life of the product the temperature error could be as much as a few degrees . as long as the error is known it can be subtracted from the indicated measurement in order to find the actual temperature . one method to do this automatically is to take advantage of the consistent average temperature of the human body . for example , if over a week the average temperature measured is 97 . 0 degrees , it could be assumed that the error term is − 1 . 8 degrees . all the temperature measurements for the period can then be scaled up by 1 . 8 degrees . the temperature sensor can also be calibrated by programming the device with an actual temperature when measured by other means . temperature data collected as described above may be transmitted via the telemetry data link to an external programmer . after the temperature data has been transmitted , it can be further processed and graphically displayed . the further processing could include any of the following : adjusting temperature data to account for drift error in the measurement ( i . e . autocalibration ), comparing the temperature data to other previous data to determine trends , combining temperature data with device activity or other sensors , and plotting temperature verses a daily cycle or monthly cycle . the temperature sensor 50 may either be incorporated into an intravenous lead or located within a housing for the sensor . the sensor may be of any convenient type such as a thermistor , resistive temperature detector , or thermocouple . a particular embodiment of a temperature sensing circuit internal to the device housing utilizes the proportional - to - absolute - temperature ( ptat ) current typically generated by the device electronics . a ptat current is normally used to generate a reference voltage with a bandgap reference voltage circuit , but also provides a convenient way of measuring the device temperature . except when heat is being generated by the device , the device temperature is equilibrated with the body temperature so that the ptat current varies with body temperature . fig2 is a block diagram of a possible implementation of such a temperature sensor . a ptat current source 100 feeds into an oscillator 101 that generates a clock signal with a frequency proportional to the ptat current . a counter 102 compares the oscillator clock frequency to a stable timebase such as could be generated by a crystal oscillator 103 . the data out of the counter 102 is then a number that is proportional to temperature that is processed by circuitry 104 and which can be transmitted to an external programmer display 106 . as described above , the temperature data may also be processed with signals from other sensors 105 . incorporating the temperature sensor within the device housing means that the sensor is subject to heating caused by , for example , high currents when the device is delivering shock therapy or reforming the electrolytic capacitors used to deliver shock therapy . temperature measurements may therefore be prohibited from being collected during such activity or within a specified time window afterward . alternatively , such temperature measurements may be flagged accordingly . having a temperature sensor incorporated into the device housing also allows monitoring of temperatures before implantation such as when the device is being stored for long periods of time . during storage of the device , for example , the temperature may be measured once per hour with an alarm flag set if the temperature ever leaves safe storage temperature limits . the flag can be announced whenever the device is interrogated . minimum and maximum storage temperatures can also be logged . the device can also be configured to issue an alarm if the present device temperature is not inside the safe operational temperature limits . this can happen because the storage temperature limits are broader than the operational temperature limits . if for example , the device has been brought in from a very cold environment ( such as outside winter temperatures ) and has not had sufficient time to warm up , the device could be outside of the operational temperature limits but still within safe storage limits . another aspect of the invention involves the manner in which temperature data is represented which impacts both the required storage space and transmission bandwidth . one method of compressing the storage space and transmission bandwidth of temperature data is to assume a fixed offset or to use a nonlinear compression scheme . for example , if an 8 bit linear scale is used to store temperature data , then the scale could be from 0 to 127 . 5 degrees with 0 . 5 degree resolution which is too coarse a resolution . with 0 . 1 degree resolution , the temperature range would only be 0 . 0 to 25 . 5 degrees , which is too small . if a 90 degree offset were to be used , the temperature range would become 90 . 0 to 115 . 5 degrees with a 0 . 1 degree resolution . this means that the 8 bit number represents the difference between 90 degrees and the actual temperature reading ( e . g . a temperature of 98 degrees would be represented as 180 , so 90 + 180 / 10 = 98 ). this would yield good temperature resolution over a limited range . the range and resolution could be adjusted for recording different types of information ( e . g . − 40 degree offset , 1 degree resolution as a coarse temperature range ). an example of a nonlinear range would be to use a different resolution depending on the temperature . for example temperatures between − 40 to 90 and 116 to 178 could have resolutions of 2 degree , and temperatures between 90 and 115 . 4 could have resolutions of 0 . 2 degrees . although the invention has been described in conjunction with the foregoing specific embodiment , many alternatives , variations , and modifications will be apparent to those of ordinary skill in the art . such alternatives , variations , and modifications are intended to fall within the scope of the following appended claims .

US-201113287751-A

a composition in compacted form for use for termite monitoring and control comprises a cellulose material which may be purified cellulose or micro - crystalline cellulose as a base bait , the composition being compacted to an optimum density of not less than approximately 1 . 033 g / cc . also disclosed is a method for monitoring and controlling termite infestations which comprises the steps of a ) preparing such a composition ; b ) placing the composition in a bait station ; c ) monitoring the station at periodic time intervals for termites ; and d ) upon observing termite infestation in the bait station , replacing the above composition with a bait composition containing a termite killing agent .

in accordance with the present invention , it has now been found that by compacting a composition comprising purified cellulose or microcrystalline cellulose as a base bait to an optimum density of not less than approximately 1 . 033 g / cc , maximum loading of termite bait stations may be achieved resulting in an extension of the time period needed for monitoring and refilling the bait stations . through the practice of the present invention , improvements in current termite bait application practices are realized by first processing the termite base bait composition into custom physical forms , such as tablet forms , with optimum densities of not less than 1 . 033 g / cc which permits bait compositions shape and form versatility and substantially greater loading of monitoring and control bait into current commercially available termite bait stations than current commercial baits . as can be seen from the tableting studies presented hereinafter , the optimum compaction / density parameters for the compositions of the invention include a density of approximately 1 . 196 g / cc , an area compaction pressure of 688 . 71 kg / cm 2 , a compaction pressure of 10 , 000 lbs . and a compaction ratio of 3 . 32 . in carrying out the practice of the invention , a composition in compacted form is prepared , the composition comprising a cellulose material which may be purified cellulose or microcrystalline cellulose . the cellulose material may be a microcrystalline cellulose in powdered form sold under the trade designation “ lattice nt - 020 microcrystalline ” cellulose having an average particle size of 20 micrometers ( fmc corporation ) or noncrystallized cellulose sold under the trade designation “ solka floc ” ( international fiber corp .) having an average particle size in the range of 20 to 100 micrometers . other brands of purified cellulose or microcrystalline cellulose may also be employed in the practice of the invention . the cellulose composition is compacted into tablets , briquets , pellets , spikes , granules or extruded forms which may be made by tablet presses , roller compaction or other means known to those skilled in the art . a product such as tc - 223 termite bait powder ( 0 . 25 % dimilin ( diflubenzuron ) and the balance being “ lattice nt - 020 ” or “ solka floc ” cellulose ) is generally well suited to termite ingestion and provides maximum termite contact due to its fine particle size . however , the one disadvantage it has is low bulk density which limits the amount that can be loaded into a bait station tube to a maximum of 27 grams with conventional packaging equipment . termite feed rates studies in a laboratory termite colony indicate that the ingestion of 9 grams per week of the tc - 223 formulation base is a reasonable estimate . while in real world situations this rate will vary dramatically due to influences such as termite species , termite population size , alternate food sources , weather conditions etc ., the rate of 9 grams per week is used for illustration purposes . at this rate , a conventional bait station tube filled with 27 grams of tc - 223 termite bait powder would be emptied in three weeks , substantially less than the standard one month time used for monitoring the bait and replacing the empty bait tube . in accordance with the present invention , the monitoring interval of , for example , 10 weeks may be extended to 11 weeks by utilizing a compacting pressure of 10 , 000 lbs ., to 12 weeks by utilizing a pressure of 15 , 000 lbs . and to 131 / 2 weeks by utilizing a pressure of 20 , 000 lbs . if the cellulose material employed is in powder form rather than granule form , it must be deaerated either prior to compacting or during compacting to prevent “ capping ” which is a condition where a lamination of the tablet occurs when pressure is suddenly released after the compaction process . powder contains a large amount of air which is compressed rather than vented during compaction . when the pressure is released , the air returns to its original volume causing cracks or laminations in the tablets . in addition to the cellulose material , the composition of the invention for use for termite monitoring and control may also contain additional termite attractants and / or pheromones . any termite attractants known to those skilled in the art may be used such as paper and other forms of cellulose . once the monitoring of the bait station confirms the presence of termites , the composition in the bait station is then filled with a bait composition containing a termite killing or controlling agent or termiticide . any known termite killing or controlling agent or termiticide can be used in the practice of the invention . these include chitin synthesis inhibitors such as hexaflumuron , flufenoxuron , lufenurin and diflubenzuron ( dimilin ), juvenile hormone mimics such as methoprene and pyriproxyfen , stomach toxicants such as sulfuramide , abamectin , cryolite , boric acid and alkali and alkaline earth salts of boric acid , and contact insecticides such as thiamethoxam , imidicloprid and fipronil , or mixtures or combinations of these agents . the termite killing or controlling agent may be present in the bait composition in various concentrations such as 0 . 01 to 10 % by weight . a carver model 3889 15 ton press equipped with the standard 1 . 125 inch inside diameter test mold kit was utilized to test various compaction characteristics and formulation parameters . the carver press employed was not equipped with heated platens on the jaws . the standard mold produces a tablet which fits nicely into a standard bait tube ( 1¼ ″ inside diameter ). the tube will hold 5 or more tablets depending upon the tablet height . tablet height is a function of formulation weight , physical form ( powder or fine granule ) and compaction pressure . the formulation weight was kept constant at 15 grams per compaction test during the evaluation . both tc - 223 powder and fine granulation were evaluated through several compaction pressures . de - aeration of the powder was accomplished by filling the mold with 10 grams of powder , placing the upper punch into the mold and lightly pressing the powder by hand to force out the air . the remaining 5 grams then fit into the mold . tablet diameter and height were measured and volumes and densities calculated . compaction pressures of 3300 , 7500 , 10000 , 15000 and 20000 lbs . were tested on powder and fine granulation formulations of tc - 223 . both formulations were taken from pilot tests using a 10 cu . ft . marion mixer . from the table , it can be seen that optimum compacting characteristics were associated with the fine granulation formulation and that 7500 lb . compaction pressure on the granule formulation appears to be the lower limit for obtaining an acceptable density tablet . using the assumed 9 grams per week termite ingestion number , enough bait could be added to last approximately 10½ weeks . the desired monitoring time is at least 12 weeks ( 3 months ). increasing the compaction pressure to 10 , 000 lbs . using the fine granule formulation tableted well and gave a much denser tablet with an approximate calculated monitoring time of the desired 12 weeks . compaction pressures of 15 , 000 lbs . and 20 , 000 lbs . using the fine granule formulation , again both tableted well and extended the monitoring time to 13 weeks and 14 weeks respectively . based upon the results set forth in the above table , the optimum compaction / density parameters appear to be 10 , 000 lbs . compaction pressure , a density of 1 . 196 gm / cc , a compaction ratio of 3 . 32 and an area compaction pressure of 688 . 71 kg / cm 2 . 40 gram slug tablets were made using the carver press with 2 . 25 ″ diameter die at 20 , 000 lbs . tableting pressure . the “ slugs ” were then ground in a hand grist mill to granules . the granules were shifted to 12 / 20 and 20 / 45 mesh sizes . overs were hand ground through a 12 mesh screen with a pestle . the 20 / 45 mesh granules were than tableted into 5 gram 1 . 25 ″ diameter tablets using the carver press at 10 , 000 tableting pressure . in view of the above , it will be seen that the several objects of the invention are achieved and other advantageous results attained . as various changes could be made in the above methods and compositions without departing from the scope of the invention , it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense .

US-201414502151-A

a cushion that is heated convectively using a positive coefficient of resistance type resistive heating element that is provided with heat exchanging surfaces , includes a mattress pad , seat or the like with a bottom surface secured around its perimeter to an air permeable top surface , forming a plenum and containing tubular spacer material therein . the plenum is connected to a power unit housing a blower , a heating module and a controller unit . the heating module preferably includes a ptc type heating element in conduction with a base plate and a number of heat exchanger fins . preferably the heating element is sandwiched between a pair of the base plates and the heat exchanger fins , and there is a seal between the base plates to minimize air flow from the blower from passing there between . a remote control for the user &# 39 ; s convenience may be provided , and a foldable antenna attachable to the convective unit facilitates wireless communication between the remote control and controller unit . the user resting atop the cushion is able to control the blower and heating module to deliver air of a desired temperature and quantity to the cushion and through the top surface . the invention advantageously replaces the current carrying , conductive wires and insulation found inside prior art heated mattresses , enhancing safety and performance while at the same time offering a cooled or ventilated capability .

initially referring to fig1 , shown is the convective cushion 10 placed upon a conventional mattress , including a plenum 12 constructed of a bottom surface 14 secured around its perimeter to a top surface 16 . the bottom surface 14 is preferably air impervious , although placement on a conventional mattress may render an air permeable surface largely impervious . the top surface 16 is air - permeable although sufficiently impervious that a greater air pressure can be maintained inside the enclosed space . inside the plenum 12 is tubular spacer material 18 or equivalent . u . s . pat . nos . 6 , 085 , 369 and 6 , 263 , 530 pioneered the use of such tubular spacer fabric 18 as an air flow structure for seats , mattresses , mattress pads , and other articles of furniture that can be sat on or laid down upon . although the preferred embodiment of this invention utilizes the same tubular spacer fabric 18 as described in the issued feher &# 39 ; 369 and &# 39 ; 530 patents , it is possible to utilize other air flow structures such as muller textile &# 39 ; s 3 mesh or strahle and hess &# 39 ; assembled woven tube fabric , as well as any other air flow structure ; however there may be substantially reduced levels of performance when compared to tubular spacer material 18 as disclosed in the above u . s . pat . nos . and herein . fig2 shows a power unit 20 for the convective cushion 10 , which includes a blower 22 for blowing air across one a ptc resistive heating module 30 including heat exchanging surfaces 32 ( see fig3 - 5 ), and pushing the air into the plenum 12 for heating the cushion 10 . alternatively , the ptc module 30 need not be energized , resulting in a ventilating function as a result of circulating ambient air through the cushion air flow structure 12 . the ptc heating module 30 with heat exchanging fins 32 is located in an adaptor 26 that matches the module 30 to the blower air outlet 27 and the air duct inlet 28 in the most aerodynamically efficient manner within the space limitations of the power unit 20 housing 21 dimensions . details such as a power cord and plugs and sockets are not shown . also shown in fig2 is a box 24 for any necessary or desired electrical circuits for mode switching , switching between multiple heaters , on and off , etc ., plus wireless remote control circuits if desired . a speed control printed circuit board may be incorporated in the space 24 shown in fig2 , which could be used to control heating as well as ventilation by coordinating ptc elements with ac power control to regulate air flow , perhaps offering more flexibility in comfort settings than the simplest form which relies solely on the ptc switch temperature characteristics of the ptc elements with a fixed air flow rate . the box 24 may optionally include a triac or other semiconductor power control for the ptc heating elements to enable the ptc elements to operate below their switch temperature design point . the ptc element switch temperature is the temperature at which the resistance starts to rise exponentially . the elements 36 are called positive temperature coefficient because , unlike ntc , or negative temperature coefficient type materials , the electrical resistivity rises with increasing temperature , instead of dropping with increasing temperature . most materials exhibit ptc characteristics because increasing temperature causes more ionic movement , crystal lattice vibration , and / or molecular motion , any of which can interfere with electron mobility . the switch temperature of ceramic ptc devices is determined by the amount of doping with certain elements , such as strontium , for example , before firing . in order to operate the ptc heating elements 36 below their design point switch temperature it is necessary to either increase the heat load beyond the capabilities or rating of the elements , by increasing air flow beyond the design point for example , or by reducing voltage to the elements , which reduces the power rating of the elements relative to the load . for a mattress pad application of the convective cushion 10 it may be more desirable to use a power reduction instead of an air flow increase , in order to maintain a very low noise level for a comfortable sleeping environment . fig3 shows the ptc heating module 30 with heat exchanging fins 32 running in the y axis and power terminals 34 on the right side . two ptc elements 36 can be seen , represented by dashed lines , mounted in the middle of the heat exchangers 32 . the preferred ptc elements 36 are rated 50 watts each and 120 vac , with a switching temperature of about 38 - 45 deg . c . max ., and are manufactured by advanced thermal products , inc . of saint mary &# 39 ; s , pa . other elements with different power and voltage ratings can be used ; however the above is the preferred embodiment because it is unnecessary to produce air at more than about 45 deg . c . max . to affect good heating performance and using elements rated for 120 vac eliminates the need for a power supply which reduces the cost of the product while increasing product reliability . if a more powerful heating effect is desired , it is a simple matter of using higher rated elements or more of the same power rated elements 36 . fig4 show the ptc heating elements 36 mounted between two base plates 38 of the heat exchangers 32 . these plates 38 are heavier than the fins 32 and serve to spread the heat outward from the ptc heating elements 36 to the far edges of the heat exchangers 32 as efficiently as possible without excessive thickness and weight . an air seal or gasket 39 is also shown in this view the purpose of which is important . the seal 39 prevents air flow between the two heat exchangers 32 , which forces all of the air flow through the fins 32 , increasing thermal transfer efficiency . the reason that this became an issue was that the thickness of the ptc heating elements rated for 120 vac is twice that of ptc heating elements rated for 12 - 24 vdc . the extra thickness results in a gap of sufficient size to permit excessive air flow between the two heat exchanger base plates 38 . the seal 39 addresses this issue to produce a more efficient apparatus that operates reliably at or very close to the switch temperature . the ptc heating module assembly 30 can be made with a single heat exchanger 32 ; however such an arrangement would not be as efficient from a thermal point of view . the heat exchangers 32 are preferably made of copper , although aluminum or any other thermally and electrically conductive material can also be used . although solder can be used to bond the ptc heating elements 36 to the heat exchanger base plates 18 , a flexible adhesive with good thermal and electrical conductivity is preferred to prevent excessive stress buildup and possible ptc element 36 cracking due to differences in coefficient of thermal expansion ( cte ) between the ptc heating element 36 material and the heat exchanger 32 material , which can be substantial , for example , approximately 10 : 1 for the ptc elements 36 and copper . referring back to fig1 , the power unit 20 may be mounted on the floor , with a flexible air duct hose 40 attached to one end of the convective cushion 10 , which is preferably at the foot of the bed . although it is possible in some instances to introduce air into the convective cushion 10 at the head of the bed it is preferred to put the air in at the foot of the bed for several reasons . the power unit 20 is designed to be very quiet , however it is not totally silent so the father away it is from the user &# 39 ; s ears the better . for heating mode , the extremities tend to require more heating than the trunk of the body ; therefore putting the warmed air in at the foot puts the warmest air in at the place where it &# 39 ; s needed most , the extremities , or feet and legs . lastly , there may not be enough space between the bed and the wall at the head of the bed to accommodate the air duct hose 40 . fig1 shows how some of the air percolates or vents up through the cushion 10 , which is enclosed in a textile envelope 12 and secured to , in this case , a bed , resulting in ventilating or heating air flowing under the covers ( not shown ), however most of the ventilating or heating air flows through the cushion 10 air flow structure 18 and vents out at the end 17 opposite from where it entered . fig1 also shows how to achieve an infra - red type remote control with the convective cushion 10 as a mattress pad . ordinarily , the power unit 20 is placed on the floor at the foot of the bed in order to enable a short length of air duct hose and to minimize blower noise perceived by the user . unfortunately , this places the power unit 20 out of the line of sight of an infra - red ( ir ), type remote control , which is less expensive than a radio frequency ( rf ), type remote . the more expensive rf remote has the advantage of not requiring a line of sight to function . shown is connecting a remote ir sensor , or detector 50 , to the power unit 20 with a length of wire 52 ( most beds are at least 6 feet in length , so the length of wire 52 needed is at least that long , plus approximately three feet for slack ), to enable the user to use an ir remote ( not shown ) without a line of sight to the power unit 20 . alternatively , either an ir or rf type remote may be designed to be used with the ptc power unit 20 in order to enable control of ventilation , or heating , and degrees of ventilation and heating , without the need for a cord connecting the remote to the power unit 20 . the solution of fig7 is to place an ir sensor 62 on the end of an articulated folding strut , or antenna 60 , attached to the power unit 20 . when the antenna 60 is unfolded vertically , the user has a line of sight to the ir detector or sensor 62 , enabling use of the ir type remote control . the ir sensor strut 60 should be capable of extending vertically at least 24 inches or more , and can be attached to the power unit 20 permanently or can use an adapter 64 to plug into the power unit 20 housing before or after unfolding . a telescopic strut ( not shown ) could also be used , but managing the wire on the inside during collapse of the telescopic type of antenna is more complex and bulky than using a folding strut 60 with rotary electrical contacts at the hinge points 66 . the folding antenna 60 design can be such that the middle leg folds to nest within the top leg and the bottom leg folds to nest within the middle leg , etc . the legs can be made of flat strips of metal or plastic with the top leg overlapping the middle one and so on . power to the sensor 62 and signals from the sensor 62 can be transmitted to the control circuit 24 in the power unit 20 via either wires in the antenna 60 or via the arms of the antenna 60 and a third wire if the arms are made of conductive material or if they are provided with conductive circuit traces and rotating contacts in the joints . fig1 and 7 show the ptc heater assembly 30 with blower 22 connected to the mattress pad 10 via a length of flexible air duct 40 . a good example of such an air duct 42 is known as uniloop , made by flexhaust , inc . it is important for good performance of the preferred embodiment 10 to ensure that there is low heat loss in the air duct 42 in cold weather and in heating mode . although there are numerous materials and techniques that can be used to make a flexible insulated air duct for the purposes of the subject invention , one example is to make an insulation sleeve 44 for the uniloop air duct hose out of volara , made by voltek corp ., which is a polymeric foam with very small closed cells enabling a relatively high r rating , or insulation rating for a relatively thin material cross section . in this case a volara sleeve or layer approximately 0 . 08 ″ thick produces very good results . a preferred form of the volara insulation sleeve 44 would be extruded with internal splines 46 as shown in fig6 to create small air gaps between the sleeve 44 and the air duct 42 to enhance the insulation performance of the sleeve with minimal bulk . this is one way of making an insulated air duct hose 40 for the preferred embodiment 10 that remains flexible and non - bulky while enabling higher performance and efficiency for the subject cushion or mattress pad in heating mode under cold ambient air temperature conditions . however it is configured , an insulated air duct hose 40 is important for best cold weather heating mode performance , especially because the air delta t in heating mode is substantially higher than in ventilation mode , in which there is no delta t because ambient air is being used for ventilation . if a source of air cooled below ambient is used , then the insulated air duct 40 will improve efficiency , however , not to the same extent , as active cooling mode delta t will still usually be less than half that of heating mode delta t . for example , heating mode may easily entail an air delta t of 45 + deg . f ., while active cooling mode with thermoelectric or stirling cycle devised as disclosed in some of my other patents , will generally not exceed 20 - 30 deg . f . referring to fig8 - 14 , an alternate embodiment vehicle seating cushion may be described , in particular application of the ptc air heating and ventilating system to a seat cushion consisting of a seat rest and backrest capable of sustaining internal air flow that will communicate thermally and convectively with the user contacting surfaces , in communication with the ptc power unit or air heating and ventilating system , via a variety of optional air pathways . as shown in fig8 , preferably a compact power unit 150 is installed proximate the “ bite line ” or separation between the seat rest 132 and backrest 134 portion of the cushion 130 , with a straight air duct 194 running from the mouth 162 of the power unit 150 to the cushion 130 . this set up is preferred as conditioned air entering the middle portion of the cushion 130 is more easily evenly distributed throughout the seat rest 132 and backrest 134 . alternatively , the power unit 150 can be installed forward of the seat rest 132 with a special air duct 195 ( fig9 ) or above and aft the backrest 134 with special duct 196 ( fig1 ). these configurations are useful for use with seats that do not have an opening or slot at the “ biteline ” between the seat and backrest cushion of the seat upon which the ptc cushion is to be installed , in order to facilitate installation of the cushion . note the airflow direction through the cushion 130 varies depending upon where the power unit 150 is placed , with the air primarily exiting the cushion 130 remote from the power unit 150 . the set up with the power unit 150 forward the seat rest 132 is advantageous for ease of control in that the power unit 150 controls could be located directly on the unit 150 and easily accessible between the user &# 39 ; s legs when seated on the cushion 130 . when the power unit 150 is located aft of the user , a wired control extends to the user or to a location accessible to the user or a remote wireless control could be used . fig1 shows a zipper ™ valve or damper 198 installed in the middle portion of the cushion 130 . the damper valve 198 serves to control the air flow between the seat rest 132 and backrest 134 portions of the cushion 130 . for example , when the power unit 150 is installed at the bite line and the valve 198 is completely closed , air flows only through the backrest 134 and not the seat rest 132 ( fig1 ). other examples , when the power unit 150 is installed atop the backrest 134 and the valve 198 closed air flows again only through the backrest 134 ( fig1 ), or when the power unit 150 is installed forward the seat rest 132 and the valve 198 closed air flows only through the seat rest 132 ( fig1 ), in both these instances the air exiting the cushion 130 through the duct 194 at the bite line . it is also possible to open or close the valve 198 to intermediate positions in order to vary the thermal effect of the cushions , by controlling the amount of air flowing through the cushions . the present invention has been described in connection with preferred and alternate embodiments , but it is understood that modifications will occur to those skilled in the appertaining arts that are within the spirit of the invention disclosed and within the scope of the claims .

US-22560505-A

a milk sampling apparatus for use with a processor controlled milking system . the apparatus may include a cassette wherein milk sample collecting elements are placed , and at least one filling member capable of being placed above a selected one of the milk sample collecting elements by a positioning system , and capable of bringing a milk sample , representatively taken from milk yielded during the milking of an animal by the processor controlled milking system , into the selected one of the milk sample collecting elements . the apparatus may further include a micro processor arranged for two - way communication with the processor controlled milking system . the micro processor may be capable of receiving an indication of the selected one of the milk sample collecting elements from the processor controlled milking system and of controlling the positioning system to move the filling member such that the processor controlled milking system is positioned above the selected one of the milk sample collecting elements dependent on receiving such a signal .

in the following description , for purposes of explanation and not limitation , specific details are set forth , such as particular techniques and applications in order to provide a thorough understanding of the present invention . however , it will be apparent to one skilled in the art that the present invention may be practiced in other embodiments that depart from these specific details . in other instances , detailed descriptions of well - known methods and apparatuses are omitted so as not to obscure the description of the present invention with unnecessary details . referring to fig1 an embodiment of a milk sampling apparatus 1 according to the present invention comprises a stainless steel chassis 3 at which a shaking or vibrating table 5 is mounted . at table 5 one , or preferably two , cassettes 7 are removably mounted , in which cassette milk sample collecting elements or tubes 9 are placed . tubes 9 are arranged vertically with their openings pointing upwards . a rubber sheet or insert 11 may be provided at the upper surface of table 5 having a punched through opening , wherein cassette ( s ) 7 can be arranged . the opening is made such that a close fit between cassette 7 and rubber sheet 11 is obtained . sheet 11 is preferably about 25 mm thick and may be of any other suitable material such as e . g . steel . the provision of rubber sheet 11 allows for possibilities to tailor - make the sampling apparatus to fit with a particular cassette or a particular practice or standard . the lateral dimensions of chassis 3 , shaking table 5 and rubber sheet 11 are preferably such that there is room for two conventional german sample cassettes , which are the largest cassettes the present inventors have found on the market . in such a cassette there is room for 70 sample tubes and 140 sample tubes will probably be sufficient in order to handle 50 milking animals during a period of 24 hours if each animal yields one sample per milking . if a single sample tube may be used more than one time for a given animal that presents for milking during the 24 hours interval , the milk sample device can handle even more animals or , alternatively , the number of sample tubes may be reduced . further , the milk sampling apparatus comprises a collection vessel 13 , which can be arranged in fluid connection with a milk passage , e . g . vessel or conduit , of an automated milking station to which the milk sampling apparatus is connectable via adjustment of a valve ( not shown in fig1 ). preferably , collection vessel 13 is by means of a vacuum supplied hose connected to a likewise vacuum supplied flow meter of the automated milking system , through which flow meter all milk as drawn from a milking animal is passed . a representative milk amount , typically about 2 % ( corresponding to about half a liter ) of the total milk amount from a milking , is by way of gravity flowed into collection vessel 13 when a sample is to be taken . the hose has in a preferred embodiment an inner diameter of 10 mm and a thickness of material of about 3 mm . collection vessel 13 is also connected to a source of compressed air via a pressure regulator ( not shown in fig1 ) for the supply of air . further , two different discharge outlets are arranged at different heights of collection vessel 13 , of which the upper outlet 15 is connected to a discharge line ( not shown in fig1 ) and the lower outlet 17 , being located at bottom of vessel 13 , is via a conduit connected to a hose ( not shown in fig1 ) arranged in a spring biased reel 23 . the milk sampling apparatus of fig1 comprises further a servo - operated xy - positioning system or table 25 arranged parallel with and above cassette ( s ) 7 . xy - positioning system 25 is a device adapted for flexible positioning of a filling member 27 above a selected one of the plurality of sample tubes in cassette ( s ) 7 . xy - positioning system 25 comprises two servo systems 29 , 31 , of which a first moves an arm 34 in the x - direction such that the position of the arm is proportional to a first provided signal value ( e . g . a voltage ) or a first provided number of pulses . the filling member , being connected to the hose of hose reel 23 , is mounted on a runner 32 that is movable along the arm in the y - direction such that the position of runner 32 and filling member 27 is proportional to a second provided signal value ( e . g . voltage ) or a second provided number of pulses . the operation is thus similar to a conventional xy recorder . a processing means 33 is provided for two - way communication with the automated milking system , which will be further depicted below with reference to fig3 . processing means 33 controls the position of the filling member as well as all valves included in the apparatus . all valves are preferably of hose clamping kind such that no pockets or spaces , where dirt and bacteria may settle , exists . the hose clamps are preferably electromechanical , wherein the hose is pinched by means of a spring and opened by means of an electromagnet . pneumatic valves may alternatively be used . the milk sampling apparatus may preferably be provided with wheels 35 and a handle 37 , such that the apparatus may easily be transported by the farmer . the apparatus comprises also a cover 39 to protect from dirt , the cover being preferably transparent such that the operation of the apparatus may be observed by the farmer . furthermore , the apparatus is designed such that the distance between the cassette and the floor is large and the handling of the sample tubes takes place from above . in such an instance the risk of contamination of the samples is minimized and a good hygiene is safeguarded . next , with reference to fig2 a – d , four different designs of the xy - positioning system as being part of the milk sampling apparatus of fig1 will briefly be discussed . a simple and low cost implementation of the transmission of force , as illustrated in fig2 a , is the use of synchronous transmission or drive belts 41 . using such transmission a reliable design , which require no maintenance , is achieved . the precision is not excellent , but acceptable for the present purpose . the force the transmission has to cope with , is only the tension force from the hose reel and any occurring friction . an alternative implementation , shown in fig2 b , uses linear rails with runners . the transmission of the runners is realized by means of gear racks 43 along rails 44 , 45 and motors 29 , 31 mounted on respective runners 46 , 47 , wherein rail 44 is firmly mounted on runner 47 . the performance of this implementation would be similar to that of the implementation of fig2 a . one drawback using this implementation , however , is that more cords must be flexible and movable . a further alternative , shown in fig2 c , is implementing a rotatable trapezoid threaded screw 49 and a runner or nut 50 for transmission , gearing , and load carrying in the x direction , said runner being prevented from being rotated . the movement in the y direction is realized by a wire 51 , which is journalled 53 at runner 50 and is attached to a further runner 54 , which in turn is attached to a biased slidable spring 55 . in this alternative , the spring 55 and the end of wire 51 attached to the spring may be considered to constitute arm 34 of fig1 . a still further alternative implementation , shown in fig2 d , uses a respective rotatable screw 56 and a respective runner 57 for transmission , gearing , and load carrying in the respective direction . in such instance weak step motors may be used . it shall be appreciated that any combination of the above discussed transmission implementations may be employed . the movements in the x and y directions have different prerequisites in terms of e . g . available space . next , with reference to fig3 , which is a schematic block diagram of the inventive milk sampling apparatus including a two - way communication interface to the automated milking system , said milk sampling apparatus , and particularly the function thereof , will be further described . when a sample is to be taken an initiating signal from a processing means 59 of automated milking system 61 is via line 63 sent to processing means 33 of milk sampling apparatus 1 together with xy coordinates for the sample tube to be used for the current sample . processor 33 sends a control signal to open valve 65 and a representative fraction of milk from a milking is then by way of gravity flowed from automated milking system 61 , through conduit 67 , and into collection vessel 13 . at this point all other valves 69 , 71 , 73 are closed . meanwhile processor 33 sends control signals to servo systems 29 , 31 instructing them to move filling member 27 to the coordinates as received from automated milking system 61 . further , when all milk has been flowed into vessel 13 compressed air is supplied to the vessel through line 75 by opening valve 69 , which is controlled by processor 33 . during the supply of compressed air valve 65 is either opened or closed ; in the latter instance the amount of air supplied has to be controlled such that the pressure in collection vessel 13 does not raise unduly much . line 75 ends inside vessel 13 close to the bottom thereof and by blowing air through the milk it is prevented from being bedded , which would not yield a representative sample . next , valve 71 is opened by processor 33 such that a major portion of the milk is evacuated through line 77 . the milk left in vessel 13 is given by the cross sectional area of vessel 13 and the height at which outlet 15 is arranged . a typical volume is 8 – 16 ml . the evacuated milk may be thrown away , recirculated to automated milking system 61 , or transported to e . g . a milk storage tank ( not shown in fig3 ). valve 71 is closed and valve 73 is opened . at this time the filling member is at place at the given coordinates , i . e . above the selected sample tube . by means of the compressed air the milk sample is flowed out of outlet 17 , through a conduit 19 and a hose 21 , and out through the orifice of filling member 27 , and finally collected in the selected sample tube . the air is blown for a period of time such that it is safeguarded that the entire milk sample has been transferred to the sample tube . the vertical distance between the orifice of filling member 27 and the upper end of the sample tube has to be small enough to secure that the entire milk sample will be collected in the correct tube . when the sample has been collected , processor 33 sends a signal to a motor 79 , which shakes shaking table 5 and thus the sample tubes , see further the description with reference to fig4 below . finally microprocessor 33 sends a completion message to automated milking system via line 81 . it shall be appreciated that all valves and all motors are controlled by means of processor 33 , which is indicated by control lines 83 . further , processor 33 is preferably provided with a memory , suitable software and a power supply ( not shown in fig3 ). also , the motors and valves are power supplied in any suitable manner . preferably , the milk sampling apparatus is provided with a battery for the supplying of power , and thus no electrical connections have to be made at the installation of the apparatus . the flexible function of the milk sampling apparatus implies that the filling of the sample tubes may be performed in any order . the filling member may be directly moved to any desired position ( in terms of position coordinates ) above the cassette . hence , no undue restriction of the movement of the filling member to predetermined positions along a predetermined path is imposed . further , if a single sample tube is to be used also for collecting a second non - consecutive sample , e . g . for sampling a cow a second time some hours later , it is readily done simply by instructing the servo systems of the xy - positioning system to move the filling member to the coordinates in question . cleaning of all parts of the milk sampling apparatus 1 that come into contact with milk may easily be performed by using the conventional cleaning of the automated milking system . by providing a drain outlet below any suitable xy coordinate position and by moving the filling member 27 to this position cleaning is simply performed by opening valves 65 and 73 ( and possibly by opening a valve ( not shown ) at the automated milking station side of conduit 67 ) and letting the cleaning fluid pass through line 67 , vessel 13 , lines 19 , 21 and filling member 27 and be discharged through said drain outlet . valve 73 may be repeatedly closed and opened during the cleaning process such that vessel 13 becomes repeatedly entirely filled with cleaning fluid to enhance cleaning of vessel 13 . valve 69 may be opened such that compressed air is mixed with the cleaning fluid and if it is desirable to also clean line 77 , valve 71 is opened . if a more frequent cleaning is desired , e . g . subsequent to each sample being taken out , cleaning fluid may be supplied through line 77 by means of connecting it to a pump and a cleaning fluid supply ( not shown in fig3 ). in order to minimize the distance that the filling member has to transverse in order to reach a drain outlet , drain outlet channels can be arranged along one or more sides of the milk sampling apparatus . if such channels are arranged along all sides filling member 27 has never to be moved more than half the width of the milk sampling apparatus . two - way communication between the processor of the automated milking machine and the processor of the milk sampling apparatus according to the present invention is realized through communication bus 63 , 81 . connection of this bus and of milk conduit 67 are the only connections that necessarily have to be performed at installation of the milk sampling apparatus . however , also connection of conduit 75 to the source of compressed air is conveniently performed at installation as well as connection of conduit 77 if the milk flowed through this conduit is to be recovered . communication from the automated milking station to the milk sample apparatus may preferably include various kinds of control commands and interrogation and information messages , whereas communication in the opposite direction include various kinds of information and alarm messages . communication from the automated milking station to the milk sampling apparatus may particularly include any of : i . initiation of milk sampling ( xy coordinates for the selected sample tube is included in the message ). ii . initiation of a cleaning cycle , which instructs processor 33 of the milk sampling apparatus to take the steps as described above . iii . instructions that automatic cleaning shall be performed after each sample being taken . communication from the milk sampling apparatus to the automated milking station may particularly include any of : i . information of successful completion of milk sampling . ii . electric error alarming message . iii . loose cover alarming message . iv . erroneously placed sample tube or missing sample tube alarming message . various kinds of alarming functions can be arranged by providing the milk sampling apparatus with suitable sensors . finally , with reference to fig4 , which illustrates an embodiment of shaking table 5 as being part of the milk sampling apparatus 1 of fig1 , this aspect of the invention will be described closer . the sample tubes are typically prepared with a preservative prior to milk sampling , which preservative shall restrain the milk from turning to sour before the samples have been delivered to the laboratory and been analyzed . this preservative is to be dissolved in the milk . such dissolving typically takes a certain period of time , during which the increase of bacteria in the milk speeds up , and thus the risk that the milk turns to sour increases . the sample tubes are typically delivered to the farmer in a cleaned and preservative prepared condition . the preservative may be 2 - bromo - 2 - nitropropane - 1 , 3 - diol , also widely commercially available under the trademark bronopol , which is crystallized in the bottom of the tubes . the cassette with the prepared sample tubes are typically to be used during a 24 hours period of time , which implies that that the tubes are standing for such a period in the milk sampling apparatus in a milk farm environment without any individual covers . it is under such circumstances desirable to safeguard a fast dissolving of the preservative in the milk . the shaking table 5 of the milk sampling apparatus according to the present invention is thus used to accelerate this dissolving by shaking sample tubes 9 . the shaking table in fig4 is arranged on chassis 3 of fig1 by means of four elastic isolator feet 85 , preferably made of rubber or plastic , of which only two are indicated in fig4 . two cassettes 7 with sample tubes 9 are arranged on shaking table 5 as schematically illustrated in fig4 . the table 5 is being shaken by means of motor 79 rotating an eccentric disk 83 . the shaking table 5 can be moved in two transverse directions ( x and y directions ) and rotated around a third axis , the z axis , being perpendicular to x and y dimensions . the shaking operation may be affected by the mutual placement of various parts of the milk sampling apparatus such as shaking table , motor , eccentric disk , cassette , sample tubes and elastic isolator feet . furthermore , the weights and weight distributions of the eccentric disk and of the shaking table may be altered . system constants such as rotation speed of the eccentric disk , spring constant and damping constant of the elastic isolator feet may also be altered . all these parameters affect the shaking function and thus a number of actions may be taken in order to properly design the shaking table to yield an appropriate agitation of the samples . other shaking tables that may be used in the present invention are disclosed in u . s . pat . nos . 4 , 102 , 649 and 5 , 259 , 672 , which patents hereby are incorporated by reference . if no agitation of the sample tubes is performed , the preservative has partly or completely become dissolved after about an hour , but this may in some applications be a too long period of time since the growth of bacteria has started . by using the shaking table of the present invention the dissolving of preservative in milk is strongly accelerated . preferably , shaking is performed subsequent to each taken milk sample . other dissolving acceleration means may be used as a complement or instead of the shaking table , such as ultrasonic devices or any other suitable agitating means known in the art . further , it shall be appreciated that a representative small amount ( e . g . 8 – 16 ml ) of milk can be sampled directly from the automated milking system , see e . g . u . s . pat . no . 5 , 303 , 598 . in such version of the present invention collection vessel 13 of fig1 may be dispensed with and a small portion of milk ( typically in the order of 10 − 4 of the total amount of milk ) may be flowed from the automated milking system , through a hose and a filling member , and into a sample tube , preferably during the entire time of the milking of an animal in order to obtain a representative sample . it will be obvious that the invention may be varied in a plurality of ways . such variations are not to be regarded as a departure from the scope of the invention . all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the appended claims .

US-24004302-A

a mechanical artificial heart valve is provided and consists of an annular shaped orifice , to which a single bicurved leaflet is hinged . the curves are planar and are generated from two intersecting circular arcs . the valve is constructed to cause a predominately accelerating flow through the orifice . this significantly reduces the flow separation from the leaflets . in addition , the leaflets are shaped so as to reduce the closing reflux volume through the orifice during the regurgitation phase of flow . these improvements tend to significantly decrease the work load on the heart .

fig1 is a plan view of a prosthetic heart valve v as seen from an upstream or top direction . a pair of leaflets 10 and 12 are housed within an annular shaped frame 13 also called means defining or forming an orifice 14 . for the purposes of discussion , a bileaflet configuration is used . in this view , the leaflets 10 , 12 are in the fully closed position to block the orifice 14 in the frame 13 . the leaflets 10 , 12 are constrained within the orifice 14 such that they are free to rotate about pivots p , p &# 39 ; mounted in the frame 13 and also are eccentrically mounted . the leaflets 10 , 12 are shown in the fully open position from an upstream or top direction in fig2 . the leaflets 10 , 12 have leading edges 10a and 12a that are bevelled to permit a reasonably tight seal at the contact surface between the leaflets 10 , 12 and a peripheral inner surface 13a of the orifice 14 formed in the frame 13 when the leaflets 10 , 12 are fully closed . the prosthetic heart valve v is shown in cross - section in fig3 with the leaflets 10 , 12 fully open . the leaflets 10 , 12 have trailing edges 10b and 12b that are also bevelled to permit a reasonably tight seal with the inner wall surface 13a of the orifice 14 in the frame 13 . the leaflets 10 , 12 are bicurved in shape . this is demonstrated in fig4 where the leaflet 12 is shown in an exploded or expanded schematic view to show further details of the features thereof improved in accordance with the present invention . the leaflet 12 is generated from sections of two intersecting circular arcs . the arcs can be thought of as being generated from two contacting right circular cylinders . the radii of curvature of the two arcs are r 1 and r 2 . these radii are not equal . the two arcs sweep two chords , defined as c 1 and c 2 . each arc forms a small semicircular shaped airfoil with cambers f 1 and f 2 . the two arcs intersect at the point where the two generating circles contact . as the two generating circles ( or cylinders ) contact at only one point , the two chords are parallel . further , this contact point can be constructed from the intersection of a line coincident with the two cords and a line through the center of both generating circles . tangents to the leading and trailing edges of the two arcs are parallel . thus , the apparent angle of attack of the leaflet is b , which is the angle between the forward flow and a line coincident with the two chords . as the two generating circles contact at only one point , the two sectors formed from the two chords c 1 and c 2 are both 2b . the mathematical relationship between the chords , cambers , radii , and angle of attack is the artificial heart valve v is shown in fig1 prior to the onset of the forward flow phase . as noted previously , for purposes of discussion , a bileaflet configuration is used . the leaflets 10 and 12 are eccentrically constrained within the confines of the orifice 14 in the frame 13 such that they are both in the fully closed position . as the forward flow phase begins , hemodynamic forces ( due to the eccentric mounting ) on the leaflets 10 and 12 cause them to rotate within the orifice 14 in the frame 13 to the fully open position , as shown in fig2 and 3 . the forward flow phase passes easily through the open leaflets 10 and 12 . they are fixed in this position by their constraints within the orifice 14 in the frame 13 and the hemodynamic forces . when the forward flow phase is complete , the hemodynamic forces change and the leaflets 10 an 12 again rotate within the confines of the orifice 14 in the frame 13 , until they come to rest in the fully closed position as shown in fig1 . they are again fixed in this position by their constraints within the orifice 14 in the frame 13 and the hemodynamic forces . reasonably tight seals are formed between the mating surfaces of the leaflets 10 , 12 at their leading edges 10a and 12a . similar seals are formed from the bevelling at the trailing edges 10b and 12b of the leaflets 10 , 12 and the inner wall surface 13a of the orifice 14 in the frame 13 , as shown in fig3 . the leaflets 10 , 12 remain in the closed position throughout the regurgitant flow phase . as another cardiac cycle begins , the leaflets again open and the above process is repeated , causing essentially unidirectional flow through the prosthesis . the unique shape of the leaflet 12 is illustrated in fig4 . as the forward flow phase enters the orifice 14 in the frame 13 , the fluid particles approach the leading edge 12a of the leaflet 12 . these particles easily travel along the initial length of the arc ( chord c 1 ), because the tangent to the arc at the leading edge is parallel to the forward flow . the fluid particles then proceed , decelerating on the convex side ( facing the centerline of the orifice ) and accelerating on the concave side ( facing the inner wall surface 13a of the orifice 14 ). as the flow is decelerating on the convex side , the potential for separation exists . however , the ratio of the chords c 1 / c 2 is less than one and before significant separation can occur , the curvature begins to change in the opposite direction . the change in curvature occurs at the intersection point of the two generating circles . as the intersection occurs at only one part , the curvatures of both arcs are identical at the transition point , yielding a smooth transition between the two arcs . this causes the flow to remain attached to the leaflet as it enters the second curved region of the leaflet 12 . as the fluid particles progress , they now accelerate on the concave side ( facing the centerline of the orifice 14 ). this change from deceleration to acceleration , on side of the leaflet 12 facing the centerline , causes a favorable pressure gradient , therefore , preventing separation . furthermore , as the fluid particles reach the trailing edge 12b , they are released into the free stream in the same direction of the forward flow . on the convex side ( facing the inner wall surface 13a of the orifice 14 ), the flow still accelerates . this is because the effective flow area on this side of the leaflet 12 decreases as the particles travel the length of the leaflet 12 . the reduction in effective flow is , of course , due to the angle of attack b of the leaflet 12 . as the fluid particles reach the trailing edge 12b , they too are released into the free stream in the same direction as the forward flow . the fact that the trailing edge arc is concave facing the centerline of the orifice 14 , will augment leaflet closure by virtue of its increased drag potential . at the onset of the regurgitation flow phase , the leaflets 10 and 12 close and return to the position demonstrated in fig1 . during the process , a certain volume of fluid is displaced in the regurgitant flow direction , by virtue of the motion of the leaflets 10 , 12 . this volume of fluid , the closing reflux volume , depends on b ( fig4 ), via the theorem of pappus . however , since the leaflet is non - planar , less fluid is refluxed due to the cambers f 1 and f 2 ( fig4 ), when compared to a at leaflet . furthermore , this effect is significantly increased as the camber ratio f 2 / f 1 increases , which is possible ( see fig4 or equations ( 1 ) and ( 2 )), only when the chord ratio c 1 / c 2 decreases . fig5 shows an alternative embodiment of the artificial heart valve leaflet . this embodiment differs from the preferred embodiment in that the two generating circles intersect at more than one point . this causes the chords c 1 and c 2 to no longer be parallel , which then causes the effective angle of attack b to be smaller than b , which is the angle formed by the cords c 1 and c 2 . the effective chord length c is no longer c 1 and c 2 . the pertinent mathematical relationships are the general purpose of the present invention is to disclose a mechanical heart valve that can be used in persons meeting the generally accepted medical criteria for the replacement of their diseased native heart valves , or dysfunctional artificial heart valves ( biological or mechanical ) already implanted . the mechanical heart valve utilizes an annular shaped orifice and one or more bicurved leaflets . according to the preferred embodiment of the present invention , the leaflet or leaflets are hinged to have pivots in the frame forming the orifice such that unidirectional flow occurs through the orifice . a significant aspect of the improvement features of the present invention is the fact that the leaflets are formed from the intersection of two circular arcs . the radii of curvature of the two intersecting arcs are not equal . the generation from two simple circular arcs makes manufacturing easier . another significant aspect of the improvement features of the present invention is that the intersecting arcs are constructed such that tangents to the arcs at both the leading and trailing edges of the leaflet ( s ) are parallel to the forward flow . this general configuration markedly reduces the turbulence in the wake region of the leaflet ( s ) and realigns the flow at the trailing edge , thus reducing the work load on the heart . a further significant aspect of the improvement features of the present invention is that the ratio of the chord of the leading edge arc to the chord of the trailing edge arc is less than one ( 1 ). this reduces separation effects by ensuring a predominantly accelerating flow through the orifice . this too reduces the work load on the heart . an additional significant aspect of the improvement features of the present invention is that regurgitation effects can be significantly reduced . this is due to the unique bicurved shape , which reduces the closing reflux or regurgitant volume by permitting larger angles of attack via the nature of its non - planar shape and because the shape of the trailing edge reduces the closing time of the leaflet ( s ). additional drawing illustrations of the prosthetic heart valve of the present invention are provided in copending u . s . ser . no . des . 375 , 300 - reif filed june 30 , 1989 concurrently herewith and incorporated herewith by reference thereto . the present invention is , of course , in no way restricted to the specific disclosure of the specification and drawings , but also encompasses any modifications within the scope of the appended claims .

US-52920090-A

the present invention provides a means to broadly protect the military and the public from injury from biological warfare weapons , particularly infective agents such as anthrax . beta - glucans , particularly whole glucan particles , pgg - glucan , and microparticulate glucan , provide general immune enhancement , thereby increasing the body &# 39 ; s ability to defend against a wide variety of biological threats . beta - glucans have been shown to increase the resistance to infection by anthrax and other infectious organisms when administered before and after infection . the anti - infective mechanism of β - glucan appears to involve stimulation of the innate immune system through increased cytokine release and cr3 receptor activation . beta - glucan is pharmaceutically stable , relatively compact , and can also be used without significant side effects . beta - glucan can also enhance the effectiveness of other medical countermeasures such as antibiotics , vaccines , and immune antibodies .

the present invention provides methods and compositions for prophylaxis or treatment of infection following exposure to pathogens such as those used in biological warfare . in a preferred embodiment , the present invention provides methods and compositions for the prophylaxis or treatment of infection following exposure to b . anthracis , also known as anthrax . the anti - infective provided by a glucan of the present invention is a useful strategy for broadly protecting the military and the public from infection by pathogens such as those used in biological warfare . the compositions of the present invention include β - glucan . more specifically , the compositions of the present invention comprise whole glucan particles , pgg - glucan , microparticulate glucan , and combinations thereof . pgg ( poly - 1 - 6 - β - d - glucopyranosyl - 1 - 3 - β - d - glucopyranose ) is a highly purified soluble glucose polymer prepared by acid hydrolysis from whole glucan particles . the β - glucan compositions may also include an optional carrier , excipient , and / or adjuvant . it has been found that the compositions of the present invention , which include one or more of the previously mentioned forms of β - glucan , significantly increase the survival of infected animals , including those infected with anthrax . the structure - function properties of the β - glucan preparation depend on the source from which it is obtained . the source of β - glucan can be yeast or other fungi , or any other source containing glucan having the properties described herein . yeast cells are a preferred source of glucans . the yeast strains employed in the present process can be any strain of yeast , including , for example , s . cerevisiae , s . delbrueckii , s . rosei , s . microellipsodes , s . carlsbergensis , s . bisporus , s . fermentati , s . rouxii , schizosaccharomyces pombe , kluyveromyces polysporus , candida albicans , c . cloacae , c . tropicalis , c . utilis , hansenula wingei , h . arni , h . henricii , h . americana , h . canadiensis , h . capsulata , h . polymorpha , pichia kluyveri , p . pastoris , p . polymorpha , p . rhodanensis , p ohmeri , torulopsis bovina , and t . glabrata . yeast cells may be produced by methods known in the art . typical growth media comprise , for example , glucose , peptone and a yeast extract . the yeast cells may be harvested and separated from the growth medium by methods typically applied to separate the biomass from the liquid medium . such methods typically employ a solid - liquid separation process such as filtration or centrifugation . in the present process , the cells are preferably harvested in the mid - to - late logarithmic phase of growth , to minimize the amount of glycogen and chitin in the yeast cells . as previously suggested , two forms of beta ( 1 , 3 )- glucans utilized in the present invention include an insoluble particle whole glucan particle , and a soluble product , pgg - glucan ( pgg ). whole glucan particles can be purified from baker &# 39 ; s yeast cell walls following extraction of cellular proteins , nucleic acids , lipids , and most non - glucose based oligosaccharides . what remains is a highly purified , 2 - 10 micron spherical β ( 1 , 3 )- glucan particle , which maintains the glucans intact three dimensional in vivo morphology from the cells from which they are derived . pgg ( poly -( 1 , 6 )- β - d - glucopyranosyl -( 1 , 3 )- β - d - glucopyranose ) is a highly purified soluble glucose polymer prepared by acid hydrolysis of whole glucan particles . the preparation of both forms of β - glucan are described below . yeast is the preferred source of β ( 1 , 3 )- glucan , but other sources which also produce β ( 1 , 3 )- glucan are contemplated within the scope of the present invention . microparticulate glucan represents another embodiment of the present invention . generally , the β ( 1 , 3 ) glucan used to prepare microparticulate glucan is isolated from yeast cell walls by conventional methods known by those of ordinary skill in the art and processed to produce microparticulate β - glucan . microparticulate glucan generally has average particle size is preferably about 1 . 0 microns or less , and more preferably about 0 . 20 microns or less . it is noted that compositions may include one or more of the various forms described herein . the preparation of whole glucan particles is described in u . s . pat . nos . 4 , 810 , 646 , 4 , 992 , 540 , 5 , 037 , 972 , 5 , 082 , 936 , 5 , 028 , 703 , 5 , 250 , 436 , and 5 , 506 , 124 , the disclosures of which are incorporated herein by reference . this process yields a product which maintains the morphological and structural properties of the glucan as found in vivo and will be referred to as a whole glucan , or whole glucan particles . preparation of whole glucan particles involves treating the yeast with an aqueous alkaline solution at a suitable concentration to solubilize a portion of the yeast and form alkali - hydroxide - insoluble whole glucan particles having primarily β ( 1 - 6 ) and β ( 1 - 3 ) linkages . the alkali generally employed is an alkali - metal hydroxide , such as sodium or potassium hydroxide . preferably , the starting material consists essentially of yeast separated from the growth medium . it is more difficult to control consumption of the aqueous hydroxide reactants and the concentration of reactants in the preferred ranges when starting with yeast compositions that are less concentrated . it is noted that the structure - function properties of the whole glucan preparation depend on the source from which it is obtained . the source of whole glucan can be yeast or other fungi , or any other source containing glucan having the properties described herein . however , yeast cells are a preferred source of glucans . the yeast should have intact , unruptured cell walls since the preferred properties of the instant whole glucan particles depend upon an intact cell wall . the treating step is performed by extracting the yeast in the aqueous hydroxide solution . the intracellular components and mannoprotein portion of the cell are solubilized in the aqueous hydroxide solution , leaving insoluble cell wall material which is substantially devoid of protein and having a substantially unaltered three dimensional matrix of β ( 1 - 6 ) and β ( 1 - 3 ) linked glucan . the preferred conditions of performing this step result in the mannan component of the cell wall being dissolved in the aqueous hydroxide solution . the intracellular constituents are hydrolyzed and released into the soluble phase . preferably , the conditions of digestion are such that at least in a major portion of the cells , the three dimensional matrix structure of the cell walls is not destroyed . more preferably , substantially all the cell wall glucan remains unaltered and intact . the aqueous hydroxide digestion step is preferably carried out in a hydroxide solution having initial normality of from about 0 . 1 to about 10 . 0 . typical hydroxide solutions include hydroxides of the alkali metal group and alkaline earth metals of the periodic table . the preferred aqueous hydroxide solutions are of sodium and potassium , due to their availability . the digestion is preferably carried out at a temperature of from about 20 ° c . to about 121 ° c . with lower temperatures requiring longer digestion times . when sodium hydroxide is used as the aqueous hydroxide , the temperature is preferably from about 80 ° c . to about 100 ° c . and the solution has an initial normality of from about 0 . 75 to about 1 . 5 . the hydroxide added is in excess of the amount required , thus , no subsequent additions are necessary . generally from about 10 grams to about 500 grams of dry yeast per liter of hydroxide solution is used . preferably the aqueous hydroxide digestion step is carried out by a series of contacting steps so that the amount of residual contaminants such as proteins are less than if only one contacting step is utilized . in other words , it is desirable to remove substantially all of the protein material from the cell . preferably such removal is carried out to such an extent that less than one percent of the protein remains with the insoluble cell wall glucan particles . an additional extraction step is preferably carried out in a mild acid solution having a ph of from about 2 . 0 to about 6 . 0 . typical mild acid solutions include hydrochloric acid , sodium chloride adjusted to the required ph with hydrochloric acid and acetate buffers . this extraction step is preferably carried out at a temperature of from about 20 ° c . to about 100 ° c . the digested glucan particles can be , if necessary , subjected to further washings and extraction to reduce the protein and contaminant level to the preferred amounts hereinbefore indicated . by conducting this process without disrupting the cell walls , the extraction can be conducted at more severe conditions of ph and temperature than was possible with the prior art procedure which included a step of disrupting the cell walls . that is , the process of this invention avoids product degradation while employing these severe extraction conditions which permits elimination of time - consuming multiple extraction steps . after the aqueous hydroxide treatment step , the final whole glucan product comprises about 5 to about 30 percent of the initial weight of the yeast cell ; preferably the product is from about 7 to about 15 percent by weight . the whole glucan particles can be further processed and / or further purified , as desired . for example , the glucan can be dried to a fine powder ( e . g ., by drying in an oven , lyophilizing or spray drying ); or can be treated with organic solvents ( e . g ., alcohols , ether , acetone , methyl ethyl ketone , chloroform ) to remove any traces or organic - soluble material , or retreated with hydroxide solution , to remove additional proteins or other impurities which may be present . the whole glucan particles obtained from the previously described process are comprised of highly pure glucan , which consists essentially of β ( 1 - 6 ) and β ( 1 - 3 ) linked glucan . following processing , the whole glucan particles contain very little contamination from protein and glycogen . preferably , the whole glucan particles are spherical in shape with a diameter of about 2 microns to about 10 microns and contain greater than 85 % by weight hexose sugars , approximately 1 % by weight protein and no detectable amount of mannan , as determined by fourier transform infrared spectroscopy . glucans obtained by prior processes contain substantially higher quantities of chitin and glycogen than the present glucans . a second chemical treatment may be used in which whole glucan particles are treated with an enzyme or an acid , to change the amount of β ( 1 - 3 ) or ( 1 , 6 ) linkages . for whole glucan particles derived from some yeast strains , enzyme treatment causes a decrease in the viscosity , and for others , it causes an increase in viscosity , but in general , alters the chemical and hydrodynamic properties of the resulting glucans . for example treatment with a glucanase enzyme , such as laminarinase , alters the β ( 1 - 3 ) linkages which alters the hydrodynamic properties of the whole glucan particles in aqueous suspensions . also for example , treatment with a mild acid , such as acetic acid , alters the β ( 1 - 3 ) linkages which additionally alters the hydrodynamic properties of the whole glucan particles in aqueous suspensions . a description of this second chemical treatment is disclosed in u . s . pat . nos . 6 , 020 , 324 and 6 , 143 , 731 . the preparation of pgg - glucan is described in u . s . pat . nos . 5 , 322 , 841 , 5 , 811 , 542 , 5 , 663 , 324 , 5 , 633 , 369 , and 5 , 817 , 643 , the disclosures of which are incorporated herein by reference . this method involves treating whole glucan particles with a series of acid and alkaline treatments to produce soluble glucan which forms a clear solution at a neutral ph . the whole glucan particles utilized in this present invention can be in the form of a dried powder , prepared by the process described above . for the purpose of this present invention it is not necessary to conduct the final organic extraction and wash steps . in order to prepare pgg , whole glucan particles are suspended in an acid solution under conditions sufficient to dissolve the acid - soluble glucan portion . for most glucans , an acid solution having a ph of from about 1 to about 5 and a temperature of from about 20 ° to about 100 ° c . is sufficient . preferably , the acid used is an organic acid capable of dissolving the acid - soluble glucan portion . acetic acid , at concentrations of from about 0 . 1 to about 5m or formic acid at concentrations of from about 50 % to 98 % ( w / v ) are useful for this purpose . the treatment is preferably carried out at about 90 ° c . the treatment time may vary from about 1 hour to about 20 hours depending on the acid concentration , temperature and source of whole glucan particles . for example , modified glucans having more β ( 1 - 6 ) branching than naturally - occurring , or wild - type glucans , require more stringent conditions , i . e ., longer exposure times and higher temperatures . this acid - treatment step can be repeated under similar or variable conditions . modified whole glucan particles from the strain , s . cerevisiae r4 , which have a higher level of β ( 1 - 6 ) branching than naturally - occurring glucans , can also be used . treatment is carried out twice : first with 0 . 5m acetic acid at 90 ° c . for 3 hours and second with 0 . 5m acetic acid at 90 ° c . for 20 hours . the acid - insoluble glucan particles are then separated from the solution by an appropriate separation technique , for example , by centrifugation or filtration . the ph of the resulting slurry is adjusted with an alkaline compound such as sodium hydroxide , to a ph of about 7 to about 14 . the slurry is then re - suspended in hot alkali having a concentration and temperature sufficient to solubilize the glucan polymers . alkaline compounds which can be used in this step include alkali - metal or alkali - earth metal hydroxides , such as sodium hydroxide or potassium hydroxide , having a concentration of from about 0 . 1 to about 10n . this step can be conducted at a temperature of from about 4 ° c . to about 121 ° c , preferably from about 20 ° c . to about 100 ° c . in one embodiment of the process , the conditions utilized are a 1n solution of sodium hydroxide at a temperature of about 80 °- 100 ° c . and a contact time of approximately 1 - 2 hours . the resulting mixture contains solubilized glucan molecules and particulate glucan residue and generally has a dark brown color due to oxidation of contaminating proteins and sugars . the particulate residue is removed from the mixture by an appropriate separation technique , e . g ., centrifugation and / or filtration . the resulting solution contains soluble glucan molecules . this solution can , optionally , be concentrated to effect a 5 to 10 fold concentration of the retentate soluble glucan fraction to obtain a soluble glucan concentration in the range of about 1 to 5 mg / ml . this step can be carried out by an appropriate concentration technique , for example , by ultrafiltration , utilizing membranes with nominal molecular weight levels ( nmwl ) or cut - offs in the range of about 1 , 000 to 100 , 000 daltons . a membrane cut - off of about 10 , 000 daltons is particularly useful for this step . the concentrated fraction obtained after this step is enriched in the soluble , biologically active pgg . to obtain a pharmacologically acceptable solution , the glucan concentrate is further purified , for example , by diafiltration . in one embodiment of the present method , diafiltration is carried out using approximately 10 volumes of alkali in the range of about 0 . 2 to 0 . 4n . the preferred concentration of the soluble glucan after this step is from about 2 to about 5 mg / ml . the ph of the solution is adjusted in the range of about 7 - 9 with an acid , such as hydrochloric acid . traces of proteinaceous material which may be present can be removed by contacting the resulting solution with a positively charged medium such as deae - cellulose , qae - cellulose or q - sepharose . proteinaceous material is detrimental to the quality of the glucan product , may produce a discoloration of the solution and aids in the formation of gel networks , thus limiting the solubility of the neutral glucan polymers . a clear solution is obtained after this step . the highly purified , clear glucan solution can be further purified , for example , by diafiltration , using a pharmaceutically acceptable medium ( e . g ., sterile water for injection , phosphate - buffered saline ( pbs ), isotonic saline , dextrose ) suitable for parenteral administration . the preferred membrane for this diafiltration step has a nominal molecular weight cut - off of about 10 , 000 daltons . the final concentration of the glucan solution is adjusted in the range of about 0 . 5 to 5 mg / ml . in accordance with pharmaceutical manufacturing standards for parenteral products , the solution can be terminally sterilized by filtration through a 0 . 22 μm filter . the soluble glucan preparation obtained by this process is sterile , non - antigenic , and essentially pyrogen - free , and can be stored at room temperature for extended periods of time without degradation . methods of producing microparticulate β - glucan are disclosed in u . s . pat . nos . 5 , 223 , 491 , 5 , 397 , 773 , 5 , 576 , 015 , 5 , 702 , 719 , and 5 , 705 , 184 , the contents of which are incorporated herein by reference . in general , microparticulate β - glucan may be produced by isolating β ( 1 , 3 ) glucan and processing it to obtain small particle sizes . an example of a process for obtaining the desired smaller particle size of microparticulate glucan , includes the use of a blender or ball mill to grind the β ( 1 , 3 ) glucan into small particles . one grinding or particle size reduction method utilizes a blender having blunt blades , wherein the glucan mixture is blended for a sufficient amount of time , preferably several minutes , to completely grind the particles to the desired size without overheating the mixture . another grinding method comprises grinding the glucan mixture in a ball mill with 10 mm stainless steel grinding balls . this latter grinding method is particularly preferred when a particle size of about 0 . 20 microns or less is desired . another form of β ( 1 , 3 )- glucan is neutral soluble glucan . neutral soluble glucan ( nsg ) is a term that describes a patented matter of composition related to pgg - glucan , but is a more generic term that covers all conformational forms of water soluble glucan . while pgg - glucan is typically a triple helix form of β - glucan , nsg generally refers to the single stranded helical form . the composition administered in the method of the present invention can optionally include , in addition to whole glucan particles , pgg , microparticulate glucan or combinations thereof , other components , such as carriers , excipients , adjuvants and / or other beneficial active components . such other beneficial active components may include the corresponding antibiotics for each of the previously - mentioned biological warfare pathogens . other components included in a particular composition may be determined primarily by the manner in which the composition is to be administered . for example , a composition to be administered orally in table form can include , in addition to β - glucan , fillers ( e . g . lactose ), binders ( e . g ., carboxymetyl cellulose , gum arabic , gelatin ), adjuvants , flavoring agents , coloring agents , other active agents ( e . g . pharmaceuticals , minerals , vitamins ) and coating materials ( e . g ., wax or plasticizer ). additionally , compositions to be administered in liquid form may include whole glucan particles , pgg , microparticulate glucan or combinations thereof , and , optionally , emulsifying agents , flavoring agents and / or coloring agents . also compositions including whole glucan particles , pgg , microparticulate glucan or combinations thereof , administered parenterally may be mixed , dissolved , or emulsified in water , sterile saline , pbs , dextrose , or other biologically acceptable carriers . the mode of administration of the β - glucan preparation can be oral , enteral , topical , parenteral , intravenous , subcutaneous , intraperitoneal , intramuscular , or intranasal . however , oral administration of β ( 1 , 3 )- glucans is a preferred embodiment of the present invention , as oral administration is both more convenient and less invasive . furthermore , it has been found that oral administration is beneficial since it stimulates the innate immune system particularly when it comes in contact with macrophages present in peyer &# 39 ; s patches . peyer &# 39 ; s patches are specialized regions in the small intestine that transport antigens to the immune cells of the gut - associated - lymphatic - tissue ( galt ). activated macrophages travel to the galt where they communicate the presence of a foreign antigen to other members of the immune system , resulting in the activation of other members of the innate immune system such as macrophages , neutrophils , and nk cells . the form in which the composition will be administered ( e . g ., powder , table , capsule , solution , emulsion ) will depend on the route by which it is administered . the quantity of the composition to be administered will be determined on an individual basis , and will be based at least in part on consideration of the severity of infection or injury in the patient , the patient &# 39 ; s condition or overall health , the patient &# 39 ; s weight , the time available before other treatment and the means of administration ( e . g . a larger amount may be administered for oral compositions than for systemic compositions ). in general , a single dose will normally contain approximately 0 . 01 mg to 500 mg of β - glucan per kilogram of body weight , preferably 1 mg to 250 mg of β - glucan per kilogram of body weight , more preferably 2 mg to 20 mg of β - glucan per kilogram of body weight . the previously described forms of β - glucan of the present invention also have been found to remain stable over extended periods of time . whole glucan particles can be stored as a pill at room temp and can be administered either orally , topically or systemically . pgg or nsg can be stored as a solution at room temperature and is usually administered systemically . whole glucan particles and pgg are both stable for at least 2 years at 25 ° c . fig7 depicts the results of a real time stability study done on imucell ™ wgp β - glucan stored at room temperature ( 25 ° c .) over a 25 months period . the composition of the sample was evaluated one per month , and showed no diminishment of the amount of active β - glucan present over the 25 month period . the average percentage of β - glucan present was 79 . 3 %, with a standard deviation of 5 . 3 . to demonstrate the activities of β - glucan compositions against a potential biological weapon , a series of studies were carried out to show how pgg and whole glucan particles can enhance resistance against anthrax infection in a mouse model system . in the studies whole glucan particles ( imucell ™ wgp glucan ) were purified from the cell walls of baker &# 39 ; s yeast and pgg was prepared by acid hydrolysis from whole glucan particles . the prophylactic effects of systemic pgg or whole glucan particles on groups of mice which were subsequently exposed to b . anthracis spores was tested . all experiments were performed twice . statistical analysis was performed on the two independent series of data . the results are shown in fig1 which clearly demonstrates that a single dose of pgg ( betafectin ; 2 . 5 mg / kg ) or 200 μg / mouse of whole glucan particles ( 10 mg / kg ) significantly increased survival time . in these experiments , the mean survival time for the control groups infected with anthrax was 8 . 4 / 8 . 5 days . the mean survival time significantly increased for the groups treated with pgg ( 10 . 2 / 11 . 5 days ) and with whole glucan particles ( 10 / 11 . 5 days ). analysis of data pooled from the two experiments showed a statistically significant increase in the survival of pgg - treated mice ( 10 . 86 days ) or whole glucan particles ( 10 . 80 days ) when compared to control ( 8 . 45 days ). the anthrax - protective effects of systemic prophylactic treatment with β ( 1 , 3 ) glucan is shown in fig2 which shows the percent of survivors during anthrax infection in mice treated with pgg or whole glucan particles . a single dose of pgg glucan ( 50 μg ) or whole glucan particles ( 200 μg ) or control saline was administered two days before lethal challenge with b . anthracis . the course of the infection was followed for a period of 10 days , and the number of survivors recorded daily . in these experiments , only 7 out of 22 control animals survived the observation period . in comparison , 19 out of the 22 pgg - treated mice and 18 of the 22 whole glucan particles - treated mice survived the same period of time . the stimulation of the host innate antimicrobial immune response by pgg ( betafectin ) and whole glucan particles resulted in enhanced microbial killing , as evidenced by a significantly reduced microbial bioburden in the lungs of treated animals shown in fig3 and 4 the results of these experiments demonstrate that a single dose of betafectin ( 2 . 5 mg / kg ) or 200 μg / mouse of whole glucan particles ( 10 mg / kg ) significantly decreased the bacterial load in the lung , and increased the number of bacteria - free mice at the end of the observation period . the enhancement of the host immune response by β ( 1 , 3 ) glucans resulted in a significant percentage (& gt ; 80 %) of the surviving treated anthrax - challenged mice being bacteria - free by 10 days post - challenge , as seen by the relative absence of b . anthracis cfus in the lung . as previously indicated , oral administration of β ( 1 , 3 )- glucans is a preferred embodiment of the present invention , as oral administration is both more convenient , less invasive , and leads to the stimulation of macrophages in the peyer &# 39 ; s patch region . fig5 a and 5b show the effect of a prophylactic oral whole glucan particles treatment regimen on mouse survival of a lethal anthrax challenge . the survival results shown in fig5 a demonstrate that daily oral prophylactic dosing of whole glucan particles (& gt ; 2 mg / kg ) significantly increased the number of anthrax survivors . in these experiments , only 5 out of 10 control animals survived the anthrax infection ( 50 % survival ). in comparison , animals treated prophylactically with daily oral doses of 2 or 20 mg / kg whole glucan particles showed 100 % survival . four times weekly oral prophylactic dosing at 2 mg / kg was not as effective as daily dosing , as a 20 mg / kg whole glucan particles dose was required to achieve significant protection ( fig5 b ). the studies described above show that β - glucan is effective against anthrax when administered before exposure . in fig6 the effect of oral whole glucan particles treatment administered after a lethal anthrax challenge on mouse survival is shown . daily oral therapeutic dosing of whole glucan particles (& gt ; 1 . 5 mg / kg ) also significantly increased the number of anthrax survivors . therapeutic dosing was begun one hour after infection . in these experiments , only 3 out of 10 control animals survived the anthrax infection ( 30 % survival ). in comparison , at the 1 . 5 mg / kg oral whole glucan particles therapeutic dose level , 80 % of the treated mice survived , and at the 13 . 3 mg / kg oral whole glucan particles therapeutic dose level , 90 % of the treated mice survived . thus , oral whole glucan particles is effective in reducing mortality from anthrax infection even when given after exposure , in addition to its effectiveness when administered prophylactically . this is significant in that it demonstrates that β - glucan can be helpful in responding to anthrax exposure for unwarned civilians which have already been exposed , which is a likely scenario in a terrorist attack . additionally , the administration of β - glucan is more effective than the direct administration of cytokines such as il - 1 , which are often used independently as immunomodulators , for several reasons . first , β - glucan has effects outside of its effect on cytokines , such as its ability to directly prime immune cells for activity against opsonized infectious particles . β - glucan also stimulates the endogenous release of various cellular mediators in balanced proportions , providing a stronger immune response due to the synergy of the various immune mediators induced . finally , cytokines — being made primarily by recombinant engineering techniques — are difficult and expensive to purify , and exhibit considerable toxicity and adverse side - effects . furthermore , glucan polymers with immunomodulating properties all share a common β ( 1 - 3 ) linked linear glucose backbone . many species , such as lentinan and scleroglucan , also contain periodic branching off the c - 6 carbon atom of glucose units in their backbone . table 1 lists a number of glucans with immunomodulatory properties and their general linkage structure as reported . regardless of the source ( e . g ., organism ) of the material , all the branched glucans listed in table 1 contain at least a single glucose unit at the branch linked through a β ( 1 - 6 ) linkage to the backbone chain . the anti - infective mechanism of action of β ( 1 , 3 )- glucan operates primarily through the stimulation of monocytes , macrophages , neutrophils , and nk cells . many of these cells are suppressed by toxins released by infectious particles , such as the toxins released by anthrax . thus , β ( 1 , 3 )- glucan helps directly counter the adverse effects of infection . the details of the mechanism of action of β ( 1 , 3 )- glucan are described below . the cr3 receptor plays a very important role in the immunomodulating activity of β - glucan . the role of cr3 in mediating the response to β - glucan was shown by research into the mechanisms of neutrophil phagocytosis of ic3b - opsonized yeast . when complement c3b has attached itself to a surface , it may be clipped by a serum protein to produce a smaller fragment , ic3b . while ic3b has been “ inactivated ” and cannot function to form a membrane attack complex , it remains attached to the surface where it serves to attract neutrophils and macrophages which can phagocytose or otherwise destroy the marked (“ opsonized ”) cell . on the surface of neutrophils and macrophages are type 3 complement receptors ( cr3 ) that bind to ic3b . the process by which yeast is eliminated by the immune system is illustrated in fig8 . stimulation of cr3 - dependent phagocytosis or degranulation requires the simultaneous ligation of two distinct sites within cr3 ; one specific for ic3b and a second site specific for yeast cell wall β - glucan . as illustrated in fig9 because they lack cell - surface cr3 - binding β - glucan , bacteria opsonized with ic3b are bound to neutrophils via cr3 but do not effectively stimulate phagocytosis or degranulation . however , as illustrated in fig1 , addition of β - glucans can bind to the lectin site of cr3 to activate immune cells bearing the receptor to trigger degranulation and / or phagocytosis of the foreign material . soluble zymosan - derived polysaccharides rich in mannans and β - glucans have been shown to bind to cr3 with high affinity , inducing a primed receptor state . [ 0085 ] fig1 confirms the role of cr3 in the immunomodulation provided by β glucan . this figure shows that oral barley glucan ( 100 mg / kg ) induces enhanced ex vivo splenic macrophage cytotoxicity against a tumor target coated with ic3b . co - injection of anti - cr3 mab with oral glucan abrogates this toxicity . in specific , this figure shows the important effect of cr3 in the stimulation of the macrophage cytotoxic response by β glucan . as noted earlier , macrophages are often suppressed by harmful pathogens such as anthrax , so their activation can serve to directly counter this effect . nk cells are another important component of the innate immune response to an infection . the function of nk cells in mediating host defense includes both direct cytotoxicity of pathogens and the secretion of cytokines such as tnf - α and ifn - γ that can potentially regulate immune responses and recruit tumoricidal macrophages . although direct cytotoxicity of pathogens by nk cells has been shown to be mediated by the activation of cr3 , additional studies have shown that this same cr3 activation event might also trigger cytokine secretion . experiments were conducted to confirm this point , the results of which are shown in fig1 . binding of small β - glucans to cr3 resulted in receptor priming for subsequent cytokine release triggered by ligation to an ic3b - opsonized target cell . the ec3bi targets did not trigger nk cell cytokine release in the absence of such polysaccharide priming , as shown in the medium control . after polysaccharide priming of cr3 , ligation to an ic3b - target cell resulted in secretion of tnf - α , ( as well as ifn - γ , ifn - α , and il - 6 , not shown ). addition of 5 mg / ml of an anti - cd11b mab ( okm1 ) blocked the secretion of all four cytokines from nk cells . anti - cr3 blocks both β - glucan binding to cr3 , as well as the binding of primed cr3 to ic3b on the ec3bi target cells . the results shown in fig1 show that nk cell secretion of cytokines occurred in parallel to cr3 activation for cytotoxicity . particulate β - glucan , that triggers a vigorous cr3 - dependent neutrophil superoxide burst , likewise triggered nk cell cr3 - dependent release of cytokines . cytokine secretion did not occur with the initial cr3 priming step that occurs with the binding of small soluble β - glucans to cr3 , and occurred only secondarily with the cr3 activation step triggered by cross - linking of the β - glucan primed cr3 to an ic3b - opsonized target cell . incubation of nk cells with ec3bi in medium alone , that does not stimulate nk cell lysis of the ec3bi , also did not trigger cytokine secretion . however , when ec3bi was added after priming of nk cell cr3 with soluble ( or particulate ) β - glucan , then the secretion of tnf - α , ifn - α , ifn - γ , and il - 6 was detected by elisa . such cytokine release was cr3 - dependent because it was blocked when an anti - cd121b mab was added at the same time as the target ec3bi . in general , the compositions of the present invention can be administered to an individual prior to or after suspected exposure to a pathogen to increase the individual &# 39 ; s capacity to resist infection . an individual skilled in the medical arts will be able to determine the length of time during with the composition is administered and the dosage , depending on the physical condition of the patient and the suspected pathogen . the composition may also be used on a routine basis as a preventative treatment to heighten the ability to resist infection of individuals working in situations with a higher than usual risk of exposure to harmful pathogens , such as health workers or soldiers operating in an active biological warfare environment . human nk cells were cultured with either particulate yeast β - glucan or soluble cr3 - binding polysaccharides for 18 hours at 37 ° c . culture supernatants were then analyzed for tnf - α by elisa . particulate yeast β - glucan ( 2 μg / ml ) and grifolan (≧ 500 kda soluble β - glucan from grifola frondosa , 2 μg / ml ) are able to bind and crosslink the lectin sites of surface cr3 molecules , causing cellular activation and the secretion of both tnf - α and il - 6 ( not shown ). by contrast , the small ( 20 kda ) soluble yeast β - glucan ( mp β - glucan ; 2 . 0 μg / ml ) and szp ( soluble zymosan polysaccharide preparation containing β - oligomannan and / or β - glucan ; 2 . 0 μg / ml ) bind only to individual cr3 molecules and do not trigger cytokine release in the absence of target cells . binding of small β - glucans to cr3 resulted in receptor priming for subsequent cytokine release triggered by ligation to an ic3b - opsonized target cell ( sheep erythrocytes opsonized with ic3b -“+ ec3b ”). the ec3bi targets did not trigger nk cell cytokine release in the absence of such polysaccharide priming , as shown in the medium control . after polysaccharide priming of cr3 , ligation to an ic3b - target cell resulted in secretion of tnf - α , ifn - γ , ifn - α , and il - 6 . addition of 5 mg / ml of an anti - cd11b mab ( okm1 ) blocked the secretion of all four cytokines from nk cells . anti - cr3 blocks both β - glucan binding to cr3 , as well as the binding of primed cr3 to ic3b on the ec3bi target cells . a sepsis model was developed in mice to characterize the efficacy of pgg glucan in protecting an immunologically intact host against serious infections . the model used intraperitoneal challenge of mice with an 0 . 1 ml suspension of e . coli strain tvdl - rat ( approximately 10 cfu / ml ) 24 hours following intravenous administration of pgg by a single bolus injection using transthoracic cardiac puncture . mice were returned to their cages and maintained on food and water , ad libitum . a control group of 10 mice were injected with 0 . 1 ml sterile saline at the time of the pgg administration . mortality rates for the treatment groups and saline control group were recorded at 48 hours after challenge . the survival rate of mice given saline was 20 %. however , the survival rates of mice given pgg at doses of 0 . 01 , 0 . 1 , 1 , and 5 mg / mouse were 90 %, 75 %, 70 % and 70 % respectively . the results demonstrated that pgg significantly reduced mortality , as compared to the saline control group ( p & lt ; 0 . 05 ) at doses as low as 0 . 01 mg / mouse ( 0 . 5 mg / kg body weight ). [ 0095 ] bacillus anthracis vollum 1b , a virulent , encapsulated , toxin - producing strain ( obtained from usamriid , ft . detrick , md ., usa ) was propagated on blood agar plates and suspended in phosphate buffered saline ( pbs ), and animals challenged in a level 3 - biocontainment facilities at dres , canada . the cell suspension was heat shocked at 80 ° c . for 11 min in pbs to kill vegetative cells and aliquots stored at − 80 ° c . the frozen spore stock was diluted and used in the protection studies . animals were maintained at a maximum of 5 mice / cage under standard laboratory condition , and water and chow were given ad libitum . injections were performed inside biosafety fumehoods , on secured animals . the anthrax model used was a well - known mouse ( balb / c ) model previously described by welkos et al . ( infect . immun . 51 : 795 - 800 , 1986 ). female balb / c mice ( 6 weeks old , 14 to 16 g ) were purchased from charles river . handling of animals was performed inside bl - 3 fume hoods , on secured animals . all protocols used in these experiments were approved by the dres institutional animal care committee ( iacc ) under protocol bk 01 - 01 and animals were cared for according to the canadian council on animal care , guide to the care and use of experimental animals , vol . 1 , 2 nd edition . five different groups of mice ( 10 animals / dose ) were inoculated subcutaneously in the flank with approximately 1 , 5 , 10 , 10 2 spores from a frozen anthrax spore stock in 0 . 1 ml vehicle ( using a 1 ml syringe , 22 gauge needle ). confirmation of the infection doses was achieved by seeding 0 . 1 ml of the suspension used for infection on blood agar plates . reading of the colony forming units ( cfus ) was performed after a 24 h incubation period . survival rate of anthrax - infected animals treated with systemic pgg & amp ; whole glucan particles . groups of 10 animals were injected ( on day - 2 ) subcutaneously in the flank ( using a 1 ml syringe , 22 gauge needle ) with 50 μg / mouse of betafectin ( 2 . 5 mg / kg ), or 200 μg / mouse of whole glucan particles ( 10 mg / kg ). on day 0 , animals were injected subcutaneously with 214 . 9 ± 97 . 1 anthrax spores / mouse . control groups , which did not receive betafectin or whole glucan particles , were included in each of the series . confirmation of the infectiousness of the dose was made by seeding 0 . 1 ml of the suspension used for infection on blood agar plate . animals were observed once a day during the first 2 days post - infection , and twice a day during the following days , until the end of the study . mice were observed daily for 10 to 11 days ( or until death ) and animals found moribund were humanely sacrificed . the survival time was recorded and the ld 50 and ld 70 calculated . at day 10 or 11 post - infection all survivors were sacrificed . stocks of anthrax spores were titered to determine the ld 50 and the ld 70 ; for the anthrax model , the ld 50 was established at 227 spores / mouse and the ld 70 at 313 spores / mouse . the mean infective dose in these studies used was 214 . 9 ± 97 . 1 spores / mouse . all experiments were performed twice . results were presented as two independent series of data and pooled data from two experiments . statistical analysis was performed on the two independent series of data and on the pooled data from the two experiments . the results shown in fig1 clearly demonstrate that a single dose of betafectin ( 2 . 5 mg / kg ), or 200 μg / mouse of whole glucan particles ( 10 mg / kg ) significantly increased survival time . the mean survival time for the control groups infected with anthrax was 8 . 4 / 8 . 5 days . the mean survival time significantly increased for the groups treated with betafectin ( 10 . 2 ( p = 0 . 044 )/ 11 . 5 ( p = 0 . 00029 ) days ) and with whole glucan particles ( 10 . 0 ( p = 0 . 064 )/ 11 . 5 ( p = 0 . 00029 ) days ). analysis of data pooled from experiments 1 and 2 showed a statistical significant increase in the survival of mice treated with betafectin ( 10 . 86 days ) or whole glucan particles ( 10 . 80 days ) when compared to control ( 8 . 45 days , p = 0 . 00021 and 0 . 00038 , respectively ). the results shown in fig2 clearly demonstrate that a single dose of betafectin ( 2 . 5 mg / kg ), or 200 μg / mouse of whole glucan particles ( 10 mg / kg ) significantly increased the number of survivors . in these experiments only 7 out of 22 control animals survived the observation period . in comparison , 19 of the 22 betafectin - treated mice ( 86 . 36 %; p = 0 . 00005 ) and 18 of the 22 whole glucan particles treated mice ( 81 . 82 %; p = 0 . 00024 ) survived over the same period of time . bacterial load of anthrax - infected animals treated with systemic pgg & amp ; whole glucan particles . to determine the bacterial load of anthrax - infected animals after treatment with systemic pgg and whole glucan particles , animals were infected and treated as described in example 3 . at the time of death , or at day 10 or 11 post - infection , major organs ( liver , spleen , and lungs ) and lymph nodes draining the infection site were harvested , weighed and homogenised in 20 ml of pbs for bacterial count . the homogenate was diluted { fraction ( 1 / 10 )}, { fraction ( 1 / 100 )}, { fraction ( 1 / 1000 )} and { fraction ( 1 / 10000 )} and 0 . 1 ml of medium and seeded on a solid culture medium ( blood agar petri dishes ) to evaluate the number of cfu / organ . the petri dishes were incubated at 37 ° c . for 24 h before counting the colonies . each experiment was repeated once and the p values were determined using a student &# 39 ; s t - test . the results shown in fig3 and 4 demonstrate that a single dose of betafectin ( 2 . 5 mg / kg ), or 200 μg / mouse of whole glucan particles ( 10 mg / kg ) significantly decreased bacterial load in the lung , and increased the numbers of bacteria - free mice at the end of the observation period . in these experiments , control animals displayed a bacterial load of 1 . 77 × 10 6 / 3 . 96 × 10 5 cfu / g lung in the survivors at the end of the observation period . in comparison , the betafectin - treated surviving animals had significantly reduced bacterial loads of 2 . 6 × 10 5 cfu / g lung ( p & lt ; 0 . 05 ) and the whole glucan particles - treated surviving animals had significantly reduced levels of 5 . 5 × 10 5 cfu / g lung ( p & lt ; 0 . 05 ). overall , 40 . 9 % of the control animals at the end of the observation period were bacteria - free in comparison to 86 . 4 % of the betafectin treated animals ( p = 0 . 0436 ) and 90 . 9 % of the whole glucan particles treated animals ( p = 0 . 0194 ). oral prophylactic treatment of anthrax - infected mice with pgg & amp ; whole glucan particles . the oral prophylactic anthrax - protective effects of whole glucan particles were tested by administering a whole glucan particles suspension ( 40 or 400 μg / mouse ) in water by gavage ( daily days — 7 to 0 , or four times a week days − 7 , − 4 . 5 , − 2 , 0 ). to comply with worker safety requirements prohibiting the handling of anthrax - infected animals , the therapeutic oral protective effects of whole glucan particles were tested by administering whole glucan particles as a 0 . 3 % w / v carboxymethylcellulose ( cmc - p325g , pl thomas ) suspension in the drinking water ( daily days 0 to + 10 ) at whole glucan particles concentrations calculated to deliver daily doses of 0 , 40 or 400 μg per mouse / day based on the estimated drinking water consumption of 6 . 5 ml water / mouse / day . actual dosing was determined by daily measurement of water consumption , factoring the number of live animals per cage each day , and was calculated to be 0 , 22 . 6 ± 3 . 5 and 200 . 3 ± 36 . 4 μg per mouse / day . control groups received either vehicle gavage or carboxymethylcellulose in their drinking water only . on day 0 , one hour after the oral dosing , animals were infected s . c . with an ld 60 dose anthrax spores . animals were observed daily until the end of the study ( day 10 ) and survival time recorded . percent survival was calculated from the ratio of surviving animals each day to the total number of infected animals in each group ( n = 10 ). each oral dosing experiment was carried out once . p values were determined using a fischer exact test . the survival results shown in fig5 a demonstrate that daily oral prophylactic dosing of whole glucan particles (& gt ; 2 mg / kg ) also significantly increased the number of anthrax survivors . in these experiments , 5 out of 10 control animals survived the anthrax infection ( 50 % survival ). in comparison , animals treated prophylactically with daily oral doses of 2 or 20 mg / kg whole glucan particles showed 100 % survival ( p = 0 . 016 ). in contrast , fig5 b shows that four times weekly oral prophylactic dosing at 2 mg / kg was not as effective as daily dosing ( p = 0 . 41 ), as a 20 mg / kg whole glucan particles dose was required to achieve significant protection ( p = 0 . 016 ). daily oral therapeutic dosing of whole glucan particles (& gt ; 1 . 5 mg / kg ) also significantly increased the number of anthrax survivors ( fig6 ). in these experiments 3 out of 10 control animals survived the anthrax infection ( 30 % survival ). in comparison , at the 1 . 5 mg / kg whole glucan particles oral therapeutic dose level , 80 % of the treated mice survived ( p = 0 . 038 ), and at the 13 . 3 mg / kg whole glucan particles oral therapeutic dose level , 90 % of the treated mice survived ( p = 0 . 01 ). while the embodiments and applications of this invention have been shown and described in detail , it will be apparent to those skilled in the art that many more modifications than mentioned above are possible without departing from the inventive concepts described herein . the scope of the present invention is thus limited only by the terms of the appended claims .

US-26820102-A

the present resistance exercising apparatus for strengthening a golf swing includes a golf club swingably connected to a telescoping shaft . the telescoping shaft in turn is axially connected to a wheel which is mounted in a frame transversely of the golf club . the wheel engages a set of four rollers which bring pressure to bear on the wheel to create resistance to rotation of the wheel . the rollers are mounted in half - moon housings and drawable to or away from the wheel to increase or decrease the resistance to rotation of the wheel . accordingly , the resistance apparatus may be set for a quicker golf swing with little resistance or a slower golf swing with greater resistance .

as shown in fig1 the present resistance golf exercising apparatus is indicated in general by the reference numeral 10 . it includes as its principal components a support 11 , a resistance creating means 12 , an extendable shaft 13 , and a golf club 14 . resistance to the swinging of the golf club 14 is created by the resistance creating means 12 . as shown in fig1 the support 11 includes a base 20 hingedly connected to a platform 21 via hinges 22 . a tee 23 formed of rubber hosing mounts a golf ball 24 on a central portion of the platform 21 . as shown in fig7 each of the hinge &# 39 ; s 22 includes a right - angled bracket 26 screwed to the platform 21 , a plate 27 screwed to the base 20 and pivotally connected via a hinge pin 28 to the bracket 26 , and an oblique extending plate 29 . the plate 29 is pivotally connected to plate 27 via a hinge pin 30 and to the bracket 26 via a removable hinge pin 31 . the hinge 22 rigidly connects the base 20 to the platform 21 and supports the resistance creating means 12 relative to the platform 21 . when the pin 31 is removed from the bracket 26 and plate 29 , the plate 29 is swingable upwardly and away from bracket 26 to rest on the surface of the base 20 . subsequently , the platform 21 is swingable upwardly and toward the resistance creating means 12 such that the resistance exercising apparatus 10 creates a compact form for storage in , for example , the trunk of a car . the support 11 further includes a set of three metal , support tubes 35 secured to the base 20 . the middle tube 35 may include an extendable portion 36 to raise or lower the resistance creating means 12 , although typically such an extendable portion 36 is not preferred since the extendable shaft 13 accommodates golfers of different heights . the resistance creating means 12 includes a rectangular tubular integral frame 40 mounted on the support tubes 35 . side members 41 , 42 of the frame 40 include bearings 43 for guiding and reducing the friction of rotation of an axle 44 through the side members 41 , 42 . the axle 44 mounts a wheel 45 which is keyed to the axle 44 with a key 46 . the wheel 45 includes a circumferential cuter surface or rim 47 . the wheel 45 is rotatable by a swinging of the shafts 13 , 14 and is typically somewhat massive . the axle 44 further includes a pair of collars 48 with set screws 49 . each of the collars 48 is disposed immediately inside of its respective side member 41 , 42 . the collars 44 prevent a longitudinal slippage of the axle 44 relative to the side members 41 , 42 , of the frame 40 . a pair of half - moon housings 50 surround portions of the wheel 45 and are mounted to upper and lower frame members 51 , 52 via a set of four adjustment pin connectors 53 . each of the pin connectors 53 includes a knob 54 fixed to an end of one of the threaded pin connectors 53 cooperating with one of the upper and lower frame members 51 , 52 . a coil spring 56 is disposed between one of the frame members 51 , 52 and a flat portion 57 of one of the housings 50 for biasing the housings 50 outwardly . each of the housings 50 rotatably mounts a pair of rollers 60 for engaging the wheel 45 . each of the rollers 60 is mounted in its respective housing 50 by a pin connector 61 and a pair of bushings 62 disposed on each of the sides of the rollers 60 and the inner flat vertically disposed surface of the housing 50 . each of the rollers 60 includes a circumferential outer surface or rim 63 for engaging in bringing pressure to bear on the rim 47 of the wheel 45 . the width of the rims 47 , 63 are substantially equal . the rim 63 of each of the rollers 60 is spaced from an inner circumferential surface 64 of each of the housings 50 . resistance to rotation of the wheel 45 is created by turning the knob 54 of at least one of the pin connectors 53 to draw in one of the rollers 60 of one of the housings 50 . as the housing 50 and roller 60 is drawn inwardly toward a plane defined by frame members 41 , 42 , the rim 63 of the roller 60 engages and brings pressure to bear on the rim 47 of the wheel 45 to create a resistance to the rotation of the wheel 45 . one or more of the pin connectors 53 may be operated to adjust the pressure and hence resistance on the wheel 45 . typically , the rollers 60 are spaced at approximately 90 ° arcs from each other to distribute pressure evenly about the wheel 45 . it should be noted that the roller 60 may be drawn out of engagement with the wheel 45 to minimize resistance to rotation of the wheel 45 . the coil springs 56 urge the flat portions 57 and housings 50 outwardly when the knob 54 is loosened . at the other extreme , the knobs 54 may be turned to draw in the roller 60 so tightly against the wheel 45 so as to maximize resistance to rotation of the wheel 45 . the roller 60 may be adjusted at increments between the extremes to provide a range of exercising resistance . it should also be noted that resistance to rotation of the roller 60 may be created by adjustment of pin connectors 61 . such pin connectors 61 may be tightened to pinch the roller 60 between the bushings 62 and hence create resistance to rotation of the roller 60 , as well as resistance to rotation of the wheel 45 . the axle 44 is integrally formed with a pair of bars 70 , 71 extending axially from the axle 44 and wheel 45 . the bars 70 , 71 are pivotally connected to axial end portion 72 of the extendable shaft 13 via a pin connector 73 . a rotatable bushing 74 is disposed about the stem of the pin connector 73 . one or more washers 75 may be disposed on the pin connector 73 to minimize wobbling of the shaft 13 relative to , and into the planes defined by , the axle bars 70 , 71 , while maintaining a free pivotal movement of the shaft 13 diametrically of the wheel 45 . a swinging of the shaft 13 axially about the axle 44 and wheel 45 causes a rotation of the wheel 45 and a rotation of the rollers 60 . the extendable shaft 13 includes the axial end portion 72 and an outer , extendable end portion 80 . the outer end portion 80 is pivotally connected to a club head or distal portion 81 of the golf club 14 via a pin connector 82 . the pin connector 82 rides in a rotatable bushing 83 which in turn rides in a ball bearing 84 . as shown in fig6 a , one or more washers 85 may be disposed between the club head 81 and the outer end portion 80 to minimize a wobbling of the club head 81 relative to the outer end portion 80 and shaft 13 while allowing a free pivotal movement between the shaft 13 and the golf club 14 . the extendable shaft 13 further includes a set of three telescoping portions 90 , 91 , 92 . outer portion 92 slides in portion 91 which in turn slides in portion 90 . as shown in fig8 each of the telescoping portions 90 , 92 includes an inner annular lip 93 for abutting in its fully extended position a ball bearing 94 , which rotatably mounts the portions 91 and 92 in their respective portions 90 and 91 . typically , middle portion 91 is greater in length than portion 90 such that portion 91 is not fully retractable into portion 90 . fig8 a shows alternate telescoping connections including an inner bushing 97 with an annular lip 98 , and an outer bushing 99 . inner bushing 97 is fixed to portion 92 and outer bushing 99 is fixed to portion 91 . fig8 b shows set screws 100 for bearing against inwardly extending annular lips 101 of respective portions 90 , 91 . in each of the embodiments , the portions 91 , 92 are rotatable relative to each other , and portion 91 is rotatable relative to portion 90 . the golf club or hand - held shaft 14 includes a club head 81 on a distal portion of the shaft 14 . it also includes a gripping , proximal , rotatable portion 105 opposite the club head 81 . the pivotal gripping portion 105 is held in place via integral annular stops 106 disposed on either end of the gripping portion 105 . the rotatable gripping portion 105 allows a rotation of the shaft 14 relative to the gripping portion 105 and the hands of a golfer . in operation , to set up the resistance exercising apparatus 10 from its compact form , the platform 21 and base 20 are placed on a floor and the removable pin 31 is inserted into the aligned portions of plate 29 and bracket 26 . a ball 24 may be disposed on the tee 23 so that the golfer feels the point in his or her swing at which ball contact is made . typically , the exercising apparatus 10 is used without a ball because one purpose of the apparatus 10 is to exercise by swinging the golf club 14 a number of times over five to fifteen minutes or more . after the base 20 and platform 21 are secured to each other , the prescribed resistance on the wheel 45 is set by turning the knobs 54 so that one or more of the rollers 60 engage and bring pressure to bear on the wheel 45 . over the course of the swing , the shaft 13 is extended at the height of a back swing a , as shown in fig1 . from the height of the back swing a to the point at which contact is made with the ball 24 , as denoted by reference character b , the shaft 13 is retracted via the sliding telescoping portions 90 , 91 , 92 and resistance to the swinging of the shafts 13 , 14 is created by the roller 60 engaging the wheel 45 , which is rotated by the swinging of the shafts 13 , 14 . from point b , at which ball contact is made , to the height of the follow - through swing at location c , the shaft 13 is extended as the telescoping portions 91 , 92 slide outwardly , and resistance to the swinging of the shafts 13 , 14 continues as the rollers 60 maintain contact with the wheel 45 . such a process is then reversed and may be repeated a plurality of times over a few minutes to build strength in and quicken a golf swing . it should be noted that over the course of the golf swing , the angle between the shafts 13 and 14 changes , and is allowed to change via the pivotal pin connector 82 . likewise , the angle between shaft 13 and axle 44 changes , and is permitted to change via the pivotal pin connector 73 . it should also be noted that over the course of a swing , axial rotation of telescoping portions 91 and 92 may occur relative to each other and relative to telescoping portion 90 . although typically rotation of the club head 81 relative to shaft 13 is minimal when a golfer swings a club 14 , the shaft 13 permits such rotation . furthermore , rotation of the hand - held gripping portion 105 may occur relative to the shaft 14 over the course of the swing . as shown in fig1 and 11 , an alternate embodiment accommodates both right - handed and left - handed golfers . it includes a removable golf club head 110 with an integral pin 111 to provide a ball - hitting face 112 to the head 110 . the shape of the head 110 is somewhat rectangular for symmetry so that both right - handed and left - handed may utilize the same club head . the club head 110 is securable to either side of a forked extension 113 . the integral pin 111 extends through the apertured forked extension 113 integrally extending from the golf club shaft 14 and is secured to the forked extension with a nut 114 . the integral pin 111 also extends through a solid , narrowed extension 115 of the telescoping shaft 13 . the integral pin 111 is paired with a second pin 116 which cooperates with one of two holes 117 on either side of the forked extension 113 to prevent rotation of the club head 110 . washers 118 on the integral pin 111 at certain positions prevent a wobbling of the shafts 13 , 14 relative to each other , but permit a pivotal movement therebetween . the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof , and it is therefore desired that the present embodiment be considered in all respects as illustrative and not restrictive , reference being made to the appended claims rather than to the foregoing description to indicate the scope of the invention .

US-55244490-A

double registration or improper registration of the data of participating teams is prevented in an online - participation game system . provided is a data communication method for game systems in which game meets are carried out by sending transmission files including data of each team to a server from each of a plurality of game terminal devices , and by thus simulating a competition among the teams , the above - mentioned method comprising : a process wherein the game terminal devices generate transmission files including an identification code and game data and send the files to the server ; and a process wherein the server checks the identification code of the transmission files received and appends the transmission files received to a registration file for the game meet , in the case when the files do not comprise identification codes identical to those in the accepted transmission file group .

the preferred embodiments of the present invention are explained below with reference to the drawings . the overall constitution of the game system is explained with reference to fig1 . the game system generally comprises a game terminal device 10 , a network 20 , and game server device 30 . the terminal device 10 includes a game device 11 and a screen device ( television monitor ) 12 . the game device 11 is constituted of a game device body 11 a , peripheral devices 11 b such as a game controller and keyboard , a memory card 11 c for holding game data or the like , and so forth . a communications interface is housed in the game device body and causes the game device 11 to function as a terminal device for carrying out data communications with the game server 30 via a communications network , such as the internet 20 . the game device 11 is able to connect to the internet via a provider 41 for providing internet connection services with a dial - up connection or by a direct connection to the internet . moreover , as discussed below , the installer of the game server 30 may also be a provider 41 of internet connection services to make possible a dial - up connection for the game terminal 10 . when a power source is applied , the game device 11 reads the startup program in the boot rom installed therein and displays the initial screen . when the player places an information - storing medium containing an os , game program , or data , such as a cd - rom in the body , the information thereof is read into the main computer system and the program is started . the program contains a reading ( communications ) program for accessing the www server discussed below . a plurality of recording areas are located in the memory card 11 c as shown in fig2 a and a plurality of files can be recorded therein . a plurality of game terminal devices 10 of this type of constitution are connected to the game server 30 via the internet 20 . the game server 30 includes a router 31 , www server 32 , db ( database ) server 33 , and be ( back end ) server 34 . the router 31 takes up data addressed to the www server 32 from an internet line 20 and transfers the data to the www server . also , the router sends data output by the www server 32 , addressed to the specific game terminal device 10 , to the internet line 20 . the www server 32 holds the home page of the game meet , stores various types of content such as image information and html files , and provides this content to the game participants . the db server 32 container data groups such as data for teams registered for the game meet tournament ( or league ), data for teams that won the tournament meet , download data such as team competition data recommended by the game program developers , and match results for the tournament . the db server provides the data contained therein on request by the www server 32 . fig3 shows an example of files held in the db server . these files include . user control files , meet files , team registration files , and match result files . a user &# 39 ; s login ( identification number ), account , number of points won , and so forth are stored in the user control files . the tournament number , tournament name , number of participating registrants , maximum number of participants , entry start time , entry end time , start time for posting results , end time for posting results , results display information , registration condition flags , registration account information , and so forth are stored in the meet files . a user &# 39 ; s login id , flags , team data , tournament number , match result codes , final rank , home site name , and so forth are stored in the team registration files . the tournament number , match code , user login id of the winning team , user login id of the losing team , match result data , match codes for previous match results of the winning team , match codes for previous match results of the losing team , and so forth are stored in the match result files . the be server 34 reads data on each team associated with the tournament , executes a program for carrying out the match on the basis of the team data , and stores the results of the competition in the match result files on the db server 33 . fig4 is a flowchart for explaining the formation of one &# 39 ; s own team . a player who has decided to participate in a game meet becomes the president of the organization owning the team , for example , and must form his / her own team to participate in the meet . this is effected by executing a game application on one &# 39 ; s own game device 11 and running the game . when the game is first started , the team management data files , competition data files , and player data files are generated ( s 2 ). in the game device 11 as shown in fig5 a , the unique identification number ( individual id , iid ) for identifying the device itself ( hardware ) is stored in advance in the flash memory in the device body 11 a . for example , the iid is the serial number . this is read from the flash memory of the device ( s 4 ). as shown in fig2 a , the iid read and the three files ( team data ) discussed above are held in the memory card 11 c ( s 6 ). it becomes possible to distinguish the game device 11 that generated the team data due to the iid being stored together with the team data . because the data is stored in the memory card 11 c , the memory card can be used on another person &# 39 ; s game device 11 . the game progresses , one &# 39 ; s own team data on the memory card 11 c is updated , the strength of the team is improved ( s 8 ), and the offline game ends . as discussed above , participants play the game with their own game device in advance , improve the competitive strength of their own teams , and improve the game parameters . in the case of a baseball game , for example , the game parameters of the team include management data , player data , and competition data . management data include the iid , team id , flag id , owner name , home site name , manager id , pitching coach id , fielding coach id , and so forth . player data include the player id , given name , jersey number , condition , character , popularity , spirit , strength , and for a pitcher , further include pitch type , pitch movement , pitch speed , control , and so forth , and for a fielder , further include right and left batting proficiency , long ball capability , running strength , arm strength , batting eye , reaction speed , hot zone , weak zone , and so forth . competition data include each pitcher &# 39 ; s numbers of wins , losses , saves , strike - outs , innings pitched , hits allowed , walks allowed , earned runs , runs allowed to opponents , home runs , a fielder &# 39 ; s total at bats , hits , rbis , steals , strike - outs , walks , dead balls ( being hit by pitched ball ), sacrifice hits , home runs , doubles , triples , errors , and so forth . this type of team data is stored in a prescribed area of the memory card 11 c as shown in fig2 a and 2b , for example . the memory card 11 c is used in connection with the controller 11 b or game device body 11 a and is removable . the memory card 11 c also includes non - volatile memory , including that which can carry out a simple game when provided a cpu and display device , as well as flash memory . the memory card 11 c may be a commonly available item such as a game cassette or cd - r ./ w , and includes items with equivalent operating effects . fig6 is a flowchart to explain the overall operation of the service provided by the game server 30 . the www server 32 conducts the holding of the game meet with the home page and recruits the participating teams . the following are posted for the purpose of conducting the meet : an outline of the tournament ( or league ) meet , meet title , registration period , results disclosure period , number of teams recruited , current registration figures , registration fees , special items ( qualifications for participation , awards , etc . ), and so forth ( s 12 ). participants register on the home page via the internet 20 . the www server 32 monitors the fairness of the registration procedures and registers participating teams . the registration application and registration check are discussed below . when participating team data ( game parameters ) is uploaded , the data is stored in the db server 33 ( s 14 ). when the recruiting period has passed , a tournament ( or league ) chart of the participating teams is formed and the order of competition is determined ( s 16 ). the db server 33 sends the data of competing teams to the be server 34 according to this order and conducts virtual matches . those match results are stored in the db server 33 . this process is repeated and the winning team is determined ( s 18 ). the winning team is presented on the home page . the high ranking winners are posted on the home page with the results in a tournament tree . also , the results of one &# 39 ; s own team can be found by inputting a participant &# 39 ; s password or the like . in the case of baseball , for example , the following are displayed : the opposing teams , winners and losers , score at each stage , results for each at bat , and so forth . the team data for the winning team and recommended teams can be downloaded . participants can thereby have their own teams compete with the winning team or other teams and replay the matches in their own game devices 11 ( s 20 ). in this way , one &# 39 ; s own team can be caused to participate in meets and the results thereof made known . fig7 is a flowchart showing the procedure for a person wishing to participate in a meet to get a login id ( or password ) and acquire the qualifications of a participant . the login id is used for personal identification , for example . once a player gets a login id , he or she can use the login id in every meet . a login id can be acquired from a specific provider 41 , for example , a provider 41 that is related to the installer of the game server 30 . many players connect to the internet with a dial - up connection and access the game server 30 . then , the players first access the provider 41 ( s 32 ), sign a service agreement , and acquire a login id ( s 34 ). the login id may be an e - mail address , for example . the login id ( lid ) is written to the flash memory in the game device body ( s 36 ) as shown in fig5 b . moreover , the login id may be provided by the server 32 . fig8 is a flowchart showing the procedure for players to participate in a meet . when a player has his / her own team , such as a baseball team , participate in a meet , a player connects the memory card to the controller , places a cd - rom with the baseball game ( application ) in the game device body 11 a , and starts the application . this cd - rom includes the software for reading the home page . the reading software is part of the baseball game or is constituted separately . for example , the reading software starts when the home page for the baseball game is selected from the menu for the baseball game displayed on the television monitor 12 . the game device 11 is connected to the internet 20 and the home page for the meet is displayed as shown in fig1 ( s 42 ). the game device 11 compares the iid in the flash rom with the iid recorded in the team data ( management data ) held in the memory card 11 c to determine whether the game data was prepared on one &# 39 ; s own game device ( s 43 ). in the case where the iids stored do not match , it is possible that the game data was not prepared with the individual player &# 39 ; s game device ( s 43 , no ); as a result , the error processing discussed below is effected and the process terminates ( s 54 ). when the iids match ( s 43 , yes ), data transmission from one &# 39 ; s own game device is identified . baseball team data is extracted from the connected memory card . in the case where a plurality of memory cards are connected , the game device 11 displays the memory cards on the television monitor 12 . the player is able to select the memory card storing team data with the menu displayed on the screen using the controller 11 b . the game device 11 reads files storing one &# 39 ; s team data ( game parameters ) discussed above from the memory card 11 c . also , the game device reads the login id stored in the flash memory housed therein . the game device forms a transmission file including the login id , team data , and flag data . as discussed below , the flag data is read by the server in order to prevent fraudulent copying or the like ( s 44 ). as shown in fig1 through 15 inclusive , the player goes into the guide for “ meet registration ” on the home page and selects the meet in which to participate through the prompting . the player inputs the login id ( or password ) and selects “ decide ” ( s 46 ). the file of team data is thereby sent from the player &# 39 ; s game device to the www server 32 ( s 48 ). the www server 32 searches the file for prescribed items , discussed below , and when there are no errors , returns a registration completion to the game device 11 . when there are errors , the errors are returned to the game device 11 . upon receiving a registration completion ( s 50 , yes ), the game device 11 displays this status on the screen of the television monitor 12 as shown in fig1 . as necessary , the registration meet name is recorded in the memory card and team registration is ended ( s 52 ). in the case of non - matching iids ( s 43 , no ) and in the case of receiving errors from the www server 32 ( s 50 , no ), the game device 11 displays the registration error on the monitor screen as shown in fig1 , for example , effects the error processing ( s 54 ) to display the cause of the error , and ends the process . fig9 is a flowchart to explain the registration processing for a team participating in the meet that is executed by the www server 32 . the file sent from the game device 11 to the www server 32 is stored once in buffer memory , not shown . the www server 32 reads the file uploaded from the game device 11 and carries out a check ( s 62 ). the www server 32 determines whether the registration period ( see fig1 ) for the meet for which the player applied has passed . if it has passed ( s 63 , no ), this is an inappropriate application ; as a result , error processing is effected such that a message to that effect is returned to the game device ( s 78 ). in the case where the registration period is ongoing ( s 64 , yes ), the www server 32 determines whether recruitment is still within the limit ( limit to the number of registrations ). in the case where the limit is exceeded ( s 66 , no ), error processing is effected such that a message to the effect that the participating teams have reached the recruitment limit is returned to the game device ( s 78 ). when the recruitment limit is not reached ( s 66 , yes ), it is checked whether an id that is identical to the login id of the player has already been registered in the database ( team registration file ) for teams registered for the meet . the login id is isolated from the pertinent portion of the file sent from the game device . this login id is read from the flash memory of the game device and written to the transmission file ; therefore , the player cannot alter this id . when registration has already occurred ( s 68 , yes ), error processing is effected , such that a message to the effect the multiple participation is not allowed is sent to the game device , in order to prevent double registration ( s 78 ). in the case when a login id identical to the player &# 39 ; s login id is not registered in the database of teams registered for the meet ( s 68 , no ), it is determined whether the player satisfies the registration requirements such as game participation qualifications ( s 70 ). the participation qualifications include an account balance for the participation registration fee . when the registration requirements are not satisfied ( s 70 , no ), error processing is effected such that a message to the effect that the requirements are not met is returned to the game device ( s 78 ). when the registration requirements are satisfied ( s 70 , yes ), it is determined whether the uploaded file is the original file ( data ) ( s 72 ). registration with game data that is not the player &# 39 ; s own data is prohibited . this can be determined according to whether the copying - prohibited flag , in the flags in the transmission file , is set . the copying - prohibited flag is set to on when the competition data is downloaded to the game device from the game server 30 ( see fig2 discussed below ) . when the uploaded file does not comprise original game parameters ( s 72 , no ), error processing is effected such that a message to that effect is returned to the game device ( s 78 ). when the uploaded file is original game parameters ( s 72 , yes ), this file is registered in the database for the baseball meet ( team registration file ). the registration completion ( see fig1 ) is sent to the game device ( s 76 ). team registration is completed in this way . after the recruitment period of the meet has passed , the be server 33 carries out the competition for each team and displays the results on the home page . upon the selection of “ meet results ” on the home page shown in fig1 , the results of the tournament meet are displayed as shown in fig1 . when tournament verification is selected , the best eight tournament results are displayed as shown in fig1 . when fig1 is scrolled to the lower portion , the screen shown in fig2 is displayed . the participant selects “ search ” and inputs his / her own , previously registered login id ( see fig1 ), whereupon the participant can search the match results for his / her own team . the match results for one &# 39 ; s own team are displayed as shown in fig2 , for example . regarding how the competitions are carried out , there is a case where be server carries out each match of a tournament one by one , and there is a case where be server carries out the calculation processing for all the matches of a tournament at one time . fig2 is a flowchart for explaining the procedure wherein the www server 32 records ( downloads ) game data from the database in the memory card 11 c of the game device 11 . here , the meet can be performed in 2 ways as follows . in one way , the be server performs each of the tournament matches one by one , in the other way , the be server performs all of the calculation processings for each of the matches of the tournament at one time . when a player selects “ download ” at the home page in fig1 , the screen shown in fig2 is displayed . when the player selects the name of the winner of each meet , the www server 32 is instructed to download the game data for that team . the www server 32 reads in the selected team ( s 82 ) and reads the pertinent team data from the db server 33 ( s 84 ). the file name for this team data is changed to be different from the file name prepared by the winner , such as “ xx meet winner ” ( s 86 ). the login id for the team data file of the winning team is removed ( nullified ) ( s 88 ) and the copying - prohibited flag prohibiting copying is set in the flag area ( s 90 ). also , as necessary , mail acquisition - prohibiting flag , for prohibiting transfer by e - mail , is set on ( see fig2 c ). in this way , team data are processed and a transfer file is formed and made into a format that can be stored in the memory card 11 c of the player and sent to the game device 11 . the player can provide downloaded game data and the game data of his / her own team to the application on his / her own game device 11 , and replay the competition . when a player uploads the above - mentioned file wherein the login id of the file was nullified as his / her own team data to the www server 32 , the player is dropped from the participants because of the null login id in the registration reception step s 68 . also , participating in a meet using another person &# 39 ; s data is prevented in step s 72 by . setting on the copying - prohibited flag . building one &# 39 ; s own team data on the basis of acquired team data and registering in a meet is prevented in step s 72 . in this way , with the embodiment of the present invention , when a game device runs a game application and forms data for a team , the identification code ( iid ) of the game device body is included in the data and stored in the memory card . when the game device is connected to the internet , a login id is written to the game device . when transmission data is formed using the data in the memory card , the formation of the transmission data is not effected when the iid in the data does not match the iid of the game device body . replacing the memory card and entering in a meet from another game device is prevented thereby and entering a meet can be authorized only with the game device that generated the game data . also , when files are transmitted , the login id is read in from the game device , included in the transmission data , and sent to the game server . it thereby becomes possible to eliminate double registration to the game server from the same game device . also , when downloading game data , the game server sets the nullification of the login id , the copy - prohibiting flag , and the mail transfer - prohibiting flag . it thereby becomes possible to prevent meet registration using another person &# 39 ; s game data . the other embodiments are hereinafter explained . the summary of this embodiment is as follows . the present embodiment is not a competition among teams but is a competition game among horses , 1 example of the characters , which are virtually bred and trained in each of the game terminals . the competitions simulate a plurality of races which are known as kikka prize and ouka prize . each race is structured from a preliminary and a final contest . the data file of each horse is sent from the game terminals to the server . the database server stores the data of the horses sent from each of the game terminals . the eb server performs the calculation processing of the preliminary and final contests for each horse which is entered for each race . the calculation processings are performed at one time . it determines the plurality of horses which win high prizes in the preliminary race , gather the horses determined , perform a final race , and determines a winning horse and horses which win high prizes . the calculation processings for the preliminary race and the final race are performed at one time after the entry . the data provision means performed by the eb server provides each of the game terminal devices , on respective request , with the data obtained from the result of the preliminary race and the data obtained from the result of the final race . the data obtained from the result of the preliminary race and the data obtained from the result of the final race are not provided to the game terminals at one time but after several days , weeks , months or years later . in short , the eb server performs the calculation processings for a plurality of competitions at one time and provides each of the game terminal devices with the data , relating to the interim results of the preliminaries and the results of the finals , gradually , for example , day by day . the advantage of this embodiment over the related art is as follows . conventionally , the server performs the calculation processing for every preliminary and final , or every kind of race . however , it complicates the operation of the game terminal devices because the player has to enter an element for the competition , such as a horse , into the server for every kind of race . in the invention performed by the described embodiment , if the player initially enters a competition in which he / she desire to participate , for example , the kikka prize or ouka prize , the server performs the calculation processings for the competitions from the preliminaries to the finals . here , if it is set that the player obtains data for the finals at one time , he / she knows the result of the race too early . therefore , this invention makes it possible to provide the data , for the results of the competitions , from the server to the game terminal devices at certain time intervals . next , the embodiment for a typical data provision from the server to the game terminal is explained with reference to the diagrams . fig2 is an calendar regarding the provision of the results of the competitions from the eb server to the game terminal devices . the calculations for all of the races ( yayoi prize , satsuki prize , etc .) are performed on sunday . the data for the preliminary contest for the yayoi prize is disclosed on the db server from monday to saturday , and the result of the final is disclosed from a day later , tuesday to saturday . the result of the preliminary contest for the satsuki prize is disclosed from tuesday to saturday , and the result of the final is disclosed from wednesday to saturday . the results of the other races are disclosed as shown in fig2 . the results of all races are accumulated on the db server and disclosed to each of the game terminals on and after sunday . it is possible for the game terminals to receive the data of the results of the races from the db server as shown in the described embodiment by selecting a particular race on the www server , and to reproduce the image of the results of the races on the game terminal . as explained above , the data communication method for game systems relating to the present invention can prohibit double registration of game data from the same person or same game device to a game meet or the like carried out on a game server , and therefore operates in a good way . also , inappropriate registration of game data using the data of another person &# 39 ; s team can be prevented because re - registration of downloaded game data can be eliminated .

US-63193700-A

a weight supporting body harness is used to support additional weight between the legs of a weight trainer . the body harness includes a torso engaging webbing assembly that directly supports the additional weights , and a waist encircling strap that stabilizes the torso engaging webbing . the weight supporting body harness allows the weight trainer to effectively increase his body weight while lowering his effective center of gravity .

the preferred embodiment of a weight supporting body harness in accordance with the present invention is illustrated generally at 10 in fig1 fig2 and fig3 . the weight supporting body harness 10 consists of a torso engaging webbing assembly generally at 30 and a waist encircling webbing 31 . a front hoop 42 and a rear s - hook 52 are used to join the torso engaging webbing assembly 30 to the waist encircling webbing 31 . front hoop 42 rests in the front of the user at the height of the user &# 39 ; s waistline and s - hook 52 rests in the back of the user , also at the height of the user &# 39 ; s waistline . front hoop 42 is shown in detail in fig4 . s - hook 52 is detailed in fig5 . the weight supporting body harness in accordance with the present invention can be divided into upper , middle , and lower thirds to facilitate easy discussion and explanation . in the upper third of the weight supporting body harness as seen in fig1 and 3 , the torso engaging webbing assembly 30 is one continuous webbing strap that is affixed to itself at two points , one located in a right front webbing length adjusting system 32a and one located in a left front webbing length adjusting system 32b . these points of webbing attachment are shown at 56 . this webbing attachment for the continuous webbing strap of the torso engaging webbing assembly 30 is illustrated in fig1 and 4 and detailed in fig6 . webbing length adjusting system 32a receives a portion of the torso engaging webbing strap in the form of a right shoulder strap 36 anchored to itself within a right front ladderlock 34 . webbing length adjusting systems 32a - d facilitate easy adjustment of webbing length via one freely moving portion of the torso engaging webbing or waist encircling webbing 31 woven into each ladderlock 34 in the upper portion of each ladderlock 34 . in the lower portion of each ladderlock 34 , the torso engaging webbing or waist encircling webbing 31 is anchored to itself within ladderlock 34 at point of webbing attachment 56 where the torso engaging webbing or waist encircling webbing 31 is sewn onto itself , as seen in fig4 and 5 . to better understand the origin , path , and termination of the torso encircling webbing in the upper third of the weight supporting body harness , follow the ensuing description . as an arbitrary point of origin , start at right front ladderlock 34 within webbing length adjusting system 32a for the right suspender strap 36 of the torso engaging webbing assembly generally at 30 . in the lower portion of this ladderlock 34 torso engaging webbing 30 is anchored to itself within ladderlock 34 at point of webbing attachment 56 where torso engaging webbing 30 is sewn onto itself as seen in fig6 . torso engaging webbing 30 then wraps one - half time around front hoop 42 as seen in fig4 changes direction , and re - enters ladderlock 34 in the upper portion of ladderlock 34 as seen in fig6 . upon exiting ladderlock 34 , torso encircling webbing 30 passes over the right shoulder of the user as right shoulder strap 36 as seen in fig2 down the back of the user fig3 and wraps one - half time around s - hook 52 fig5 . torso encircling webbing 30 is secured to itself at a point of webbing attachment 60 fig5 . after wrapping one - half time around s - hook 52 , torso encircling webbing 30 climbs the back of the user fig3 passes over the left shoulder of the user as left shoulder strap 37 , and enters the upper portion of ladderlock left front 34 within left front webbing length adjusting system 32b . torso engaging webbing 30 passes through left front ladderlock 34 , wraps one - half time around front hoop 42 as seen in fig4 changes direction , and re - enters the lower portion of left front ladderlock 34 within webbing length adjusting system 32b and terminates where it anchors to itself at point of webbing attachment 56 . a rear stabilizing webbing 53 , as seen in fig3 is situated horizontally and bridges the two diagonal sections of shoulder straps 36 and 37 of torso engaging webbing 30 as detailed in fig3 and 5 . this horizontal piece of rear stabilizing webbing 53 is secured to the right and left rear suspender strap portions 36 and 37 , respectively , of the torso engaging webbing assembly 30 at points of webbing attachment 58 . the middle third of the weight supporting body harness 10 consists of left and right individual pieces of waist encircling webbing 31 and 33 , respectively , left and right rear webbing length adjusting systems 32c and 32d , front hoop 42 , s - hook 52 , and waistbelt connector system 36 . this is illustrated in fig1 , and 3 and detailed in fig4 and 5 . each piece of waist encircling webbing 31 or 33 originates in left or right rear webbing length adjusting system 32c or 32d on ladderlock 34 left or right rear as seen in fig5 . each webbing piece 31 or 33 is anchored to itself in the portion of its associated ladderlock 34 nearest s - hook 52 . it then wraps one - half time around s - hook 52 , changes direction , and re - enters ladderlock 34 in the portion of ladderlock 34 furthest from s - hook 52 . webbing length adjusting systems 32c and 32d are detailed in fig6 . after re - entering ladderlock 34 , each waist encircling webbing 31 or 33 passes through ladderlock 34 , travels along the waistline of the user ( fig2 ) and enters the rectangular portion of a snaphook 38 . it then makes a one - half turn around that portion of snaphook 38 , changes direction , and is sewn onto itself at point of webbing attachment 54 . left and right waist belt snaphooks 38 are depicted in detail in fig4 . the lower third of the weight supporting body harness consists of a front snaplink 40 which is connected to a front end of a chain of annular rings 48 . this is illustrated in fig1 , and 3 and detailed in fig4 and 5 . chain of annular rings 48 is anchored at its rear end to s - hook 52 as seen in fig5 . it hangs between the legs of the user and reattaches to the weight supporting body harness via snaplink 40 which anchors onto front hoop 42 . the cooperation of front hoop 42 and snaplink front 40 is detailed in fig4 . in the preferred embodiment of the weight supporting body harness generally at 10 , torso engaging webbing 30 , waist encircling webbing 31 and 33 , and rear stabilizing webbing 53 are nylon or propylene , but in other embodiments they could be made of leather , cotton , or any other material suitable for withstanding the strain posed upon it by a load . in addition , they could be made using various combinations of leather , cotton , or other material . for example , torso engaging webbing assembly 30 could be leather while waist encircling webbing 31 and 33 could be cotton and rear stabilizing webbing 33 could be nylon . shoulder pads could be added to the right and left side suspender straps 36 and 37 , if desired . in the preferred embodiment , the upper , middle , and lower thirds of the weight supporting body harness intersect at s - hook 52 . in other embodiments , a snaphook , hoop , quicklink , or any such securing device or combination of securing devices could be substituted for s - hook 52 . in the preferred embodiment , snaplink 40 serves to anchor chain of annular rings 48 to front hoop 42 . in other embodiments , snaplink 40 could be replaced by a quicklink , snaphook , s - hook , or any such securing device or combination of securing devices . in the preferred embodiment , the middle third of the weight supporting body harness is composed of two pieces of waist encircling webbing 31 and 33 . in other embodiments , the middle third of the weight supporting body harness could be comprised of one piece of waist encircling webbing 31 that originates on front hoop 42 , passes along the user &# 39 ; s waistline , through s - hook 52 , continues along the waistline , and anchors to waistbelt connector system 36 that originates on the opposite side of front hoop 42 that waist encircling webbing 31 originated . the upper third of weight supporting body harness is responsible for supporting the weight attached to the chain 48 . this places all load burden on the shoulders of the wearer and none on the hips . the middle portion of the weight supporting body harness bears no load whatsoever , so the spinal column and chord are not in any way endangered . the sole purpose of the middle portion of the weight supporting body harness 10 is to make sure that the position of the weight supporting body harness 10 on the user does not get altered during use . it is analogous to guard rails on the highway . the guard rails are a safety measure that insures the proper location of automobiles on the highway . the middle portion insures proper positioning of the weight supporting body harness 10 on the user in a comfortable and safe manner . the user experiences a shift in his or her center of gravity during use . this shift is a decrease in the height of the center of gravity . this is beneficial in that no threat of a loss of balance or a toppling - over sensation exists . as described above , devices that allow the user to increase bodyweight resistance at the expense of an increase in the height of the user &# 39 ; s center of gravity are highly dangerous . a system that accomplishes the same goal that actually lowers the user &# 39 ; s center of gravity is significantly safer to use because a lower center of gravity exponentially decreases the likelihood of falling due to excessive weight borne by a trainer unaccustomed to bearing such weight . the manner for using the weight supporting body harness 10 of the present invention is readily discernible from fig1 , and 3 . the user dons the weight supporting body harness by opening the two snaphooks 38 and removing them from their anchoring position on front hoop 42 . the user must also open snaplink 40 and remove it from its anchoring position on front hoop 42 . these two steps can be performed in random order . the user then places his or her arms within the torso engaging webbing assembly 30 of the weight supporting body harness 10 such that the weight supporting body harness rests on his or her shoulders as depicted in fig1 , and 3 . essentially this is done by holding the weight supporting body harness in such a manner that the user can put his or her head in between the two shoulder engaging straps 36 and 37 of the torso engaging webbing assembly 30 that comprise the upper third of the weight supporting body harness . the weight supporting body harness is positioned correctly on the shoulders when both front hoop 42 and s - hook 52 are in line with the user &# 39 ; s waistline . if they are not so situated then the user should adjust the lengths of the shoulder straps 36 and 37 of the torso encircling webbing assembly 30 by using the webbing length adjusting systems 32a and 32b as seen in fig4 . this is accomplished by moving ladderlocks 34 along the freely sliding portions of the shoulder straps 36 and 37 which are connected to ladderlock 34 in the upper portion of ladderlock 34 as seen in fig6 . when the weight supporting body harness 10 is correctly positioned on the shoulders of the wearer , snaphooks 38 can be re - anchored to front hoop 42 . the length of waist encircling webbings 31 and 33 that run along the waistline of the user in the middle third of the weight supporting body harness should be adjusted such that when snaphooks 38 are anchored to front hoop 42 , the user experiences three to five centimeters ( one to two inches ) of slack along his or her waistline . all of the above steps should be completed prior to loading any weightlifting weights 50 onto the chain 48 of the weight supporting body harness 10 . the weight supporting body harness 10 is compatible with both standard and olympic type weights 50 . for use with standard type weights , snaplink 40 must be opened and removed from chain of annular rings 48 . then chain of annular rings 48 can be passed through the hole in the center of weightlifting weight 50 and refastened to snaplink 40 . once snaplink 40 is anchored to front hoop 42 , the weight supporting body harness 10 is ready for use . for use with olympic type weights 50 , snaplink 40 is merely passed through the hole in the center of weightlifting weight 50 and subsequently anchored to front hoop 42 . the length of chain of annular rings 48 can be varied by removing snaplink 40 from the end of chain of annular rings 48 and refastening it on any individual annular ring that comprises chain of annular rings 48 . this feature serves to adjust the positioning of weightlifting weight 50 according to the desire of the user . weightlifting weight 50 properly rests between the legs of the person wearing the weight supporting body harness , as depicted in fig1 . more than one weightlifting weight 50 can be used . from the description above , a number of advantages of the weight supporting body harness 10 in accordance with the present invention become apparent . a weight trainer can use more than just his or her own bodyweight when performing pull - ups , chin - ups , or dips , thus eliminating the need for increasing the number of repetitions or sets performed in response to muscle growth . a weight trainer using the present invention will support the weight with his or her shoulders without increasing the height of the trainer &# 39 ; s center of gravity , but instead with lowering of their center of gravity , thus avoiding the possibility of endangering the trainer or nearby trainers if he or she should experience a loss of balance and / or a toppling - over sensation . a weight trainer can support this additional weight in a safe manner without the possibility of endangering his or her spinal column and chord as a result of having weight suspended by the hips , thus avoiding the risk of suffering a slipped disc or a pinched spinal nerve . a weight trainer can support the desired amount of additional weight with a weight supporting body harness 10 that is compatible with the conventional standard or olympic size weight found in all gyms , thus eliminating the need for the unnecessary purchase of weight specific to the weight supporting body harness 10 and otherwise useless . a weight trainer can use the weight supporting body harness 10 without making multiple adjustments of the weight supporting body harness 10 when sharing it with a partner , thus allowing the trainer to recuperate in between sets instead of interrupting the flow of the workout by spending time in between sets making numerous adjustments to allow the weight supporting body harness 10 to fit different users . a weight trainer can weight train using additional weights without the aid of a supporting rack or structure or any assistance from a partner for donning the weight supporting body harness 10 , thus allowing the trainer to train alone without limiting the space available for other exercise machinery . a weight trainer can perform the desired weight training with a weight supporting body harness 10 that is portable , easy to use , convenient , compact , and within the budget of individual trainers rather than the budgets of individual gyms , thus allowing the trainer to set the adjustments to his or her own dimensions and carry it with him or her when traveling . while a preferred embodiment of a weight supporting body harness in accordance with the present invention has been set forth fully and completely hereinabove , it will be apparent to one of skill in the are that a number of changes in , for example , the thickness of the materials used , the amounts of weights used and the like could be made without departing from the true spirit and scope of the present invention which is accordingly to be limited only by the following claims .

US-48939295-A

the present invention is an eyelash curler comprising a fixed stainless steel spatula with attached handle . it utilizes no moving parts . it is operated by a one - handed procedure , allowing the user to apply controlled pressure onto the lash with just the thumb , resulting in a better curl and less chance of pinching the eyelid . it is more easily sterilized and kept clean than conventional eye curlers , thus reducing the possibility of eye irritation or infection resulting from its use .

detailed descriptions of the preferred embodiment are provided herein . it is to be understood , however , that the present invention may be embodied in various forms . therefore , specific details disclosed herein are not to be interpreted as limiting , but rather as a basis for the claims and as representative basis for teaching one skilled in the art to employ the present invention in virtually any appropriately detailed system , structure or manner . fig1 : this is a view of the present invention as held for immediate use in curling eyelashes . in the preferred embodiment , the device is comprised of a wood or plastic handle 1 of about 3 inches in length ; a neck 20 connecting handle and spatula ; and a spatula 10 of stainless steel . the spatula 10 is about 1 . 625 inches in length , and is substantially rectangular in shape , but is curved along its horizontal axis , as can also be seen in fig2 . the spatula has a convex face 40 , and a concave face 30 . the top edge 2 , and the side edge 5 of the spatula 10 are both straight edges . however , the bottom edge 3 of the spatula is curved slightly upward . side edge 5 is about 1 . 125 inches in length . the thickness of each edge , particularly edges 2 and 3 , is important . the curling edge 3 is the thinner edge , and is preferably about 0 . 003 inches in width . the stabilizing edge 2 is thicker , and can be at least 0 . 004 inches in width . the view of this apparatus is how it would look if it were to be gripped with the right hand ready to curl the eyelash with its curved edge 3 held firmly by the thumb and eyelash in between , and straight edge 2 to be held firmly with the index finger . the eyelash would be held between thumb and edge 3 . moving the invention up or down while firmly grasping the eyelash will curl the eyelash . fig2 : this view shows the convex side 40 of the present invention , with lower curved edge 3 designed for curling the eyelash , in front , and behind the straight edge 2 used for placement of the index finger for guidance and maneuverability . this drawing shows the handle 1 formed to allow positive grip for remaining 3 fingers to hold onto , with indentations 4 for easier gripping . fig3 displays a side view showing a profile of the present invention , as it would look if set down on its topside . the handle 1 does show the grip pattern 4 facing upwards . the convex face of the invention is shown facing down . fig4 : frontal view of apparatus shows both curved edge 3 and straight edge 2 of invention , as it would look if set down on a flat surface . the handle 1 is to the rear , with the grip pattern 4 not clearly visible , as it is when viewed from the side , as in fig3 . fig5 is another view of the preferred embodiment of the invention from the leading edge 5 , in a front perspective view . in fig6 , the preferred embodiment of the invention is demonstrated in use , by a right - handed user . this stainless steel , one - piece eyelash tool is curved on one side 3 that touches the eyelash 12 and thumb 15 . the opposite side 2 is a straight edge used for placement of the index finger 11 . the handle 1 is gripped by the remaining three fingers 12 , 13 , 14 for stability and accuracy . the thumb 15 is held firm against the eyelash 12 and the curved side 3 of the invention to curl the eyelash with one motion while the index finger 11 holds the straight edge 2 of the apparatus for guidance and maneuverability . the device is moved smoothly downward ( for upper eyelashes ) or upward ( for lower eyelashes ) while the thumb holds the eyelash slidably against the thin lower edge 3 . by using the present invention in this manner , the problem of breaking or denting eyelashes is greatly alleviated . the user has greater control over the degree of pressure applied to the eyelash , and thus better results are attained . the present invention is uniquely suited for curling eyelashes . however , by using the same technique , other thin surfaces , such as paper or ribbon , can be similarly given a curled appearance . for example , a spool of ribbon can be easily and quickly curled by pulling one ribbon end with the free hand while curling with the other hand and the present invention . it is important to mote that the present invention is more easily sterilized , or otherwise cleaned , than conventional eyelash curlers . eye irritation , and indeed eye infections , is a very common product of eye curling , and other eye cosmetic treatments , when safe hygiene is not practiced . the present device , being constructed of dishwasher - safe components , and no moving imparts , is easy to keep clean or even sterilize . thus , using the present invention after cleaning , with clean hands and fresh cosmetics , will lower the risk of infection compared to non - sterilizable prior art eyelash curlers . while embodiments of the present invention have been shown and described , various modifications may be made without departing from the spirit and scope of the present invention ; and all such modifications and equivalents are intended to be covered within the instant patent . therefore , the entire scope of the present invention should be determined by the appended claims and their legal equivalents , rather than by the given examples .

US-39488306-A

a push button connection for an injection device comprising a push button and a driving part . the two parts of the push button connection are mounted to each other and is relatively rotatable to each other . in order to minimize the friction occurring between the push button and the driving part when relatively rotated forces are transmitted via a pivot bearing . in order also to minimize the effect of forces appearing dislocated from the centre line a number of radial bearings having a little friction diameter is provided .

it is an object of the present invention to provide a dose button connection for an injection device which minimizes the forces a user most apply to inject a dose . when a user pushes on the injection button , the force applied is directed to the forward movement of the driving part , however , since the push button and the driving part rotate relatively to each other a friction between these rotating parts will occur . the user therefore also has to apply a force large enough to overcome this friction . one way of minimizing the force a user must apply in order to perform an injection is therefore to minimize this friction . by forming a pivot bearing between the two parts , the surface area of interaction between the two objects can be minimized and the radius of the resulting friction force can be kept at a minimum . in order to secure the fit between the push button and the driving part and on the same time direct forces applied on the periphery of the push button to the driving part at least one radial bearing between the push button and the protrusion is formed . preferably one radial bearing is formed in the upper area and one is formed in the lower area both having the least possible radius of friction . in this way forces applied at in the periphery area of the push button and causing tilting of the push button on the protrusion of the driving part is properly transferred . if a user applies a force eccentric to the centre axis of the push button i . e . on a peripheral area of the button , the push button will tilt and a reaction torque will occur at the radial bearings . in order to minimize this force pair , which in this load case is located at the distance from the radial bearing surface to the centre axis of the system , this distance , which again equals the radius of the protrusion , must be as little as possible and the distance between the bearings as long as possible . however , in order not to make the protrusion too narrow and fragile it is preferred to balance the radius of the bearings , such that the upper bearing has the smallest diameter and the lower bearing at the root of the column shaped protrusion has a diameter large enough to resist the bending force as a result of the offset applied push button forces . in order to assemble the push button in an irreversible manner making it difficult to dissemble , it is preferred to secure the push button at the intended position by adding a track into which a rim on the harder part is forced during the manufacture of the injection device . the necessary compliance of the push button for the assembly snap - on can be secured by selection of a soft material and / or a vertical slit in the hollow section of the geometry . further the materials used for the push button and the protrusion on the driving part could be materials having low internal friction , or the materials could be surface treated in order to lower the internal friction . the push button used in the connection has a central bore dedicated to engage the protrusion provided on the driving part . the bottom of the bore is preferable formed with a pivot . this pivot bears on a surface of the protrusion thus forming a pivot bearing . an “ injection pen ” is typically an injection apparatus having an oblong or elongated shape somewhat like a pen for writing . although such pens usually have a tubular cross - section , they could easily have a different cross - section such as triangular , rectangular or square or any variation around these geometries . as used herein , the term “ drug ” is meant to encompass any drug - containing flowable medicine capable of being passed through a delivery means such as a hollow needle in a controlled manner , such as a liquid , solution , gel or fine suspension . representative drugs includes pharmaceuticals such as peptides , proteins ( e . g . insulin , insulin analogues and c - peptide ), and hormones , biologically derived or active agents , hormonal and gene based agents , nutritional formulas and other substances in both solid ( dispensed ) or liquid form . all references , including publications , patent applications , and patents , cited herein are incorporated by reference in their entirety and to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein . all headings and sub - headings are used herein for convenience only and should not be constructed as limiting the invention in any way . the use of any and all examples , or exemplary language ( e . g . such as ) provided herein , is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed . no language in the specification should be construed as indicating any non - claimed element as essential to the practice of the invention . the citation and incorporation of patent documents herein is done for convenience only and does not reflect any view of the validity , patentability , and / or enforceability of such patent documents . this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law . the invention will be explained more fully below in connection with a preferred embodiment and with reference to the drawings in which : fig1 show a cross section view of the connection between a push button and a driving part . fig2 show a cross section view of the connection and the forces occurring . the figures are schematic and simplified for clarity , and they just show details , which are essential to the understanding of the invention , while other details are left out . throughout , the same reference numerals are used for identical or corresponding parts . when in the following terms as “ upper ” and “ lower ”, “ right ” and “ left ”, “ horizontal ” and “ vertical ”, “ clockwise ” and “ counter clockwise ” or similar relative expressions are used , these only refer to the appended figures and not to an actual situation of use . the shown figures are schematic representations for which reason the configuration of the different structures as well as there relative dimensions are intended to serve illustrative purposes only . in that context it may be convenient to define that the term “ distal end ” in the appended figures is meant to refer to the end of the injection device carrying the injection needle whereas the term “ proximal end ” is meant to refer to the opposite end pointing away from the injection needle . fig1 discloses the connection between the push button 10 and the driving part 20 . when a user wants to inject a dose , which he or she has first selected , the user pushes the push button 10 which then moves the driving part 20 axially forward in the injection device . during this forward movement of the driving part 20 it also rotates usually because it is interfaced with a dose dial drum which is threadedly connected to a housing . such injection device is described in details in ep 1 . 003 . 581 . the combined axial and rotatable movement of the driving part 20 drives the set dose out from the injection device . as the users finger pushes on the push surface 11 of the push button 10 it is unable to rotate due to the friction between the users finger and the push button 10 whereas the driving part 20 is forced to rotate due to its interface , therefore a relative rotation between the push button 10 and the driving part 20 takes place . the push button 10 which could be manufactured from a suitable polymeric material being softer that the material from which the driving part 20 is manufactured comprises at the proximal end a push surface 11 which is contacted by the user &# 39 ; s finger when a dose is to be injected and an opposite located cylindrical bore 12 with a circular cross section . the most proximal part 13 of the bore 12 has a smaller diameter than the remaining part 14 of the bore 12 . at the distal end of the bore 12 , a radial extending track 15 is provided . the push surface 11 could be provided with a tactile cut - out 16 informing visual impaired users on the content of the injection device and the most proximal bottom surface 17 of the bore 12 is formed with a raised pointer forming a pivot 18 . the driving part 20 is provided with a protrusion 21 having a circular cross section and a top surface 22 . this protrusion 21 has at its proximal end a top part 23 with a decreased diameter compared to the remaining part 26 of the protrusion 21 . further the protrusion 21 is provided with a radial extending rim 24 at its distal end . in the area around this rim 24 , the protrusion 21 is provided with a belt 25 with a slightly raised diameter . when the push button 10 is mounted on the protrusion 21 of the driving element 20 it is simply clicked on such that the extending rim 24 enters the track 15 . this forms a connection almost impossible to disconnect since the polymeric material of the push button 10 is softer than the material from which the protrusion 21 is produced . in this position the pivot 18 formed in the most proximal bottom surface 17 of the bore 12 bears on the top surface 22 of the protrusion 21 thus forming a pivot bearing 22 , 18 . further the push button 10 is radially supported by the protrusion 21 at the top part 23 forming a radial top bearing 23 , 13 . the belt 25 on the protrusion 21 bears on an area of the remaining part 14 of the bore 12 thus forming a radial bottom bearing 14 , 25 . in fig2 the push button 10 connection is disclosed with the various forces occurring when a user applies an injection force in the peripheral area of the push button 10 . when the user applies an injection force a at the peripheral area of the push button 10 a vertical reaction force b will appear at the pivot point 22 , 18 , at the same time a radial force c will occur at the upper radial bearing 13 , 23 . since the upper radial bearing 13 , 23 are located at the top part 23 having the smaller diameter , the resulting torque is relatively small . further , a radial force d will occur at the lower radial bearing 14 , 25 , however due to the distance between the upper radial bearing 13 , 23 and the lower radial bearing 14 , 25 , the force resulting on the lower radial bearing 14 , 25 is relatively small . some preferred embodiments have been shown in the foregoing , but it should be stressed that the invention is not limited to these , but may be embodied in other ways within the subject matter defined in the following claims .

US-52597608-A

a system providing for on - site reclamation and re - use of reclaimed antimicrobial solution includes a dispenser , at least one receptacle , piping , and at least one pump . the dispenser sprays antimicrobial solution toward moving raw food products . unspent antimicrobial solution that did not contact the moving raw food products and rebound antimicrobial solution that did contact the raw food products combine to form a reclaimed antimicrobial solution . the reclaimed antimicrobial solution is collected in the receptacle and is pumped through the piping to a location for reuse .

fig1 is an overhead view of a disinfecting stage of an antimicrobial solution reapplication system 10 in accordance with the present invention . reapplication system 10 is an antimicrobial solution reclamation and reapplication system that permits the reuse of reclaimed antimicrobial solution during raw food processing by reclaiming unspent antimicrobial solution as well as some spent antimicrobial solution . reapplication system 10 is beneficial for reducing antimicrobial solution consumption through more efficient utilization of antimicrobial solution , which in turn also decreases the impact on the environment . although the specification discusses the reclamation and reapplication of antimicrobial solution , those skilled in the art will recognize that the system and method can be used for the reclamation and reapplication of any sprayed - on additive . fig1 specifically shows a first disinfecting stage 12 of reapplication system 10 . disinfecting stage 12 removes organics , inorganics , and other particulates from raw food product 14 and generally includes conveyor rail 16 , opposing first wall 18 a and second wall 18 b , spray nozzles 20 , first receptacle 22 a and second receptacle 22 b , and circulation system 24 ( shown and described in fig2 ). conveyor rail 16 is positioned between opposing first and second walls 18 a and 18 b and moves raw food product 14 through disinfecting stage 12 . spray nozzles 20 are positioned along opposing first and second walls 18 a and 18 b of disinfecting stage 12 and contain antimicrobial solution for disinfecting raw food product 14 . as raw food product 14 moves along conveyor rail 16 , spray nozzles 20 continuously spray antimicrobial solution towards raw food product 14 . antimicrobial solution is sprayed from spray nozzles 20 at a force sufficient to propel the droplets of antimicrobial solution to raw food product 14 as well as the opposing wall . although fig1 depicts spray nozzles 20 in staggered positions along opposing first and second walls 18 a and 18 b , spray nozzles 20 can be positioned along first and second walls 18 a and 18 b in a variety of arrangements as long as the droplets of antimicrobial solution leaving spray nozzles 20 are not prevented from reaching either raw food product 14 . additionally , although fig1 depicts spray nozzles 20 positioned along first and second walls 18 a and 18 b , spray nozzles can also be positioned on the ceiling or floor , as long as the antimicrobial solution is directed to contact raw food product 14 . first and second receptacles 22 a and 22 b are positioned directly below spray nozzles 20 along first and second walls 18 a and 18 b , respectively . as antimicrobial solution is sprayed toward raw food product 14 , a portion of the antimicrobial solution will contact raw food product 14 ( spent antimicrobial solution ) and adhere to the surface of raw food product 14 . because raw food products 14 are spaced along conveyor rail 16 at a distance from one another , a portion of the antimicrobial solution will not contact raw food products 14 ( unspent antimicrobial solution ). the unspent antimicrobial solution thus continues past conveyor rail 16 and raw food product 14 . the unspent antimicrobial solution from spray nozzles 20 positioned along first wall 18 a continues toward opposing second wall 18 b , while the unspent antimicrobial solution from spray nozzles 20 positioned along second wall 18 b continues toward opposing first wall 18 a . once the unspent antimicrobial solution contacts respective opposing first or second wall 18 a and 18 b , the unspent antimicrobial solution runs down first or second wall 18 a and 18 b and into first and second receptacles 22 a and 22 b , respectively . although fig1 depicts first and second receptacles 22 a and 22 b positioned directly below spray nozzles 20 , first and second receptacles 22 a and 22 b can be positioned at different locations as long as first and second receptacles 22 a and 22 b are positioned to receive the unspent antimicrobial solution after it is sprayed at raw food products 14 . when the antimicrobial solution contacts raw food product 14 , the chemicals in the antimicrobial solution react with dissolved organics , inorganics , and / or particles on the surface of raw food product 14 and are typically not be reused without first being reconditioned . in contrast , the unspent antimicrobial solution collected in first and second receptacles 22 a and 22 b are not significantly degraded because it never contacted raw food product 14 and did not undergo any chemical reactions , such as oxidation or reduction . in addition , the unspent antimicrobial solution will not be buffered outside any ph specifications that may be set by the fda and / or usda . some spent antimicrobial solution containing organic contaminants and particulates ( rebound antimicrobial solution ) will also be collected into first and second receptacles 22 a and 22 b along with the unspent antimicrobial solution through deflection or rebound off raw food product 14 , or through other means . although a portion of the rebound antimicrobial solution is mixed with the unspent antimicrobial solution ( reclaimed antimicrobial solution ) in first and second receptacles 22 a and 22 b , the level of organic contaminants and particulates in the reclaimed antimicrobial solution is still less than the level of organic contaminants and particulates that would be present in a solution combining all of the spent antimicrobial solution and all of the unspent antimicrobial solution . after the reclaimed antimicrobial solution has been collected , the reclaimed antimicrobial solution is typically sent through a reconditioning step , such as filtration , prior to reuse in order to satisfy usda standards and regulations . optionally , if the level of organic contaminants and particulates in the reclaimed antimicrobial solution satisfies usda standards and regulations , the reclaimed antimicrobial solution can be immediately reused without reconditioning . examples of suitable antimicrobial solutions include , but are not limited to : octanoic acid , acetic acid , acidified sodium chlorite , carnobacterium maltaromaticum stain cb1 ; cetylpyridinium chloride ; citric acid ; chlorine dioxide ; 1 , 3 di - bromo - 5 , 5 - dimethylhydantoin ; citric acid , phosphoric acid , and hydrochloric acid mixtures ; lactic acid ; lactoferrin ; lauramide arginine ethyl ester ; nisin , ozone ; hydrogen peroxide ; peroxyacetic acid ; peroxyoctanoic acid ; potassium diacetate ; lactic acid and acidic calcium sulfate mixtures ; lactic acid , acidic calcium sulfate , and propionic acid mixtures ; lactic acid , calcium sulfate , and sodium phosphate mixtures ; sodium metasilicate ; trisodium phosphate ; or combinations thereof . an example of a suitable commercially available antimicrobial solution includes , but is not limited to , trade designated sanova ® acidified sodium chlorite , available from ecolab , incorporated , saint paul , minn . fig2 is a diagram of reapplication system 10 showing disinfecting stage 12 , which includes spray nozzles 20 and first and second receptacles 22 a and 22 b , circulation system 24 , and raw food processing stage 26 . circulation system 24 generally includes piping 28 and pump 30 . circulation system 24 circulates the reclaimed antimicrobial solution through reapplication system 10 . piping 28 of circulation system 24 generally includes collection line 28 a , intermediate line 28 b , t - line 28 c , recycle line 28 d , and secondary line 28 e . collection line 28 a connects disinfecting stage 12 and pump 30 . first intermediate line 28 b connects pump 30 to t - line 28 c , which is connected to recycle line 28 d and secondary line 28 e . when the reclaimed antimicrobial solution comes to t - line 28 c , the reclaimed antimicrobial solution can be passed to recycle line 28 d , secondary line 28 e , or both recycle line 28 d and secondary line 28 e . recycle line 28 d connects t - line 26 c and disinfecting stage 12 . secondary line 28 e connects t - line 28 c and raw food processing stage 26 . pump 30 pumps the unspent solution collected in first and second receptacles 22 a and 22 b through piping 28 . after the mixture of unspent and rebound antimicrobial solution has been reclaimed by first and second receptacles 22 a and 22 b ( shown in fig1 ), circulation system 24 of reapplication system 10 transports the reclaimed antimicrobial solution back to disinfecting stage 12 or raw food processing stage 26 for reuse . optionally , reapplication system 10 can also include a reconditioning stage upstream of food processing stage 26 or disinfecting stage 12 . fig3 is a block diagram of reapplication system 10 showing first food processing stage 26 a , second food processing stage 26 b , disinfecting stage 12 , and third food processing stage 26 c . during raw food processing , the raw food product is passed through numerous food - processing stages in preparation for human consumption . first and second food processing stages 26 a and 26 b occur prior to disinfecting stage 12 and can be any number of food processing steps where antimicrobial solution is needed . for example , first or second food processing stages 26 a and 26 b can include stripping the raw food product of any undesirable exterior protection , such as , but not limited to : removing hides from red meat carcasses , removing feathers from poultry products , or removing stems from fruit or vegetable products . first and second food processing stages 26 a and 26 b can also include eviscerating the raw food product , including , but not limited to , removing the guts of red meat carcasses or poultry products . third food processing stage 26 c occurs after disinfecting stage 12 and can include any number of food processing steps where antimicrobial solution is needed . for example , third food processing stage 26 c can include applying antimicrobial solution to a raw food product after it has been stripped of any undesirable products and is ready for human consumption , including , but limited to , a cold carcass application of antimicrobial solution . after antimicrobial solution has been sprayed in disinfecting stage 12 , the reclaimed antimicrobial solution is collected for transport and reuse in various raw food processing stages of reapplication system 10 . circulation system 24 ( shown in fig2 ) transports the reclaimed antimicrobial solution to any raw food processing stage in reapplication system 10 requiring antimicrobial solution , including first , second , and third food processing stages 26 a , 26 b , and 26 c . the reclaimed antimicrobial solution can also be transported back to disinfecting stage 12 for reuse . while fig3 depicts recapturing the reclaimed antimicrobial solution for reuse only during disinfecting stage 12 of reapplication system 10 , the reclaimed antimicrobial solution can be recaptured and reused during any stage of reapplication system 10 . additionally the reclaimed antimicrobial solution can be sent through a filtering stage prior to reuse . the reclaimed antimicrobial solution recapture and reapplication system of the present invention collects the reclaimed antimicrobial solution from a raw food processing stage and transports the reclaimed antimicrobial solution to the reapplication system for reuse . during numerous stages of raw food processing , antimicrobial solution is sprayed toward a raw food product for disinfection . a portion of the antimicrobial solution contacts the raw food product and reacts with organics , inorganics , and other particulates on the surface of the raw food product to disinfect the raw food product . another portion of the antimicrobial solution does not contact the raw food product and remains in substantially fresh condition . the unspent antimicrobial solution , along with any rebound antimicrobial solution is collected and transported through a circulation system of the reapplication system to a raw food processing stage for reuse . although the present invention has been described with reference to preferred embodiments , workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention .

US-33523906-A

a walk - behind power turf aerator having a rigid unibody construction and being shiftable into a highly compact configuration to facilitate transportation and storage thereof . the power turf aerator utilizes the reciprocal movement of a plurality of generally upright tines to create a relatively dense plug pattern in the turf .

referring initially to fig1 , aerator 10 generally includes a body 12 , a plurality of wheels 14 , a motor 16 , a handle assembly 18 , and a guard bar 20 . wheels 14 are rotatably coupled to body 12 and provide for movement of aerator 10 on a surface , such as the turf being plugged by aerator 10 . wheels 14 can be any suitably strong conventional wheel assembly known in the art such as , for example , gleason corporation model # 99059450 , available from gleason corporation of milwaukee , wis . motor 16 is rigidly coupled to and supported by body 12 near the front of body 12 . motor 16 is preferably a 5 horse power briggs and stratton intekâ gasoline engine with a 6 : 1 gear ratio ; however , motor 16 can be any suitable engine of similar horse power and gear ratio such as , for example , commercially available honda ohv engines . handle assembly 18 is hingedly coupled to the rear of body 12 and can be pivoted relative to body 12 between an operating position where handle assembly 18 extends upwardly and rearwardly from body 12 ( as shown in fig1 ) and a transport / storage position where the handle is folded generally over body 12 ( as shown in fig1 , which is discussed in detail below ). guard bar 20 is rigidly coupled to body 12 and extends generally upwardly and forwardly from the front of body 12 . guard bar 20 includes a generally horizontally extending portion that is positioned in front of motor 16 and protects motor 16 from frontal impact . the horizontal portion of guard bar 20 also provides a convenient manual grasping location to facilitate lifting of aerator 10 onto or off of an elevated surface , typically during transportation or storage of aerator 10 . referring now to fig1 through 3 , body 12 is comprised of a right side member 22 , a left side member 24 , a front member 26 , and a rear member 28 . preferably , body 12 has a unibody construction . as used herein , the term “ unibody construction ” shall denote a manner of constructing an apparatus wherein sheet metal body parts are combined with stress - bearing elements to form the body and chassis of the apparatus as a single piece , as opposed to attaching body parts to a frame . it is preferred for members 22 , 24 , 26 , 28 of body 12 to be formed from sheet metal that has been bent to provide enhanced structural rigidity . as perhaps best shown in fig3 , a number of the edges of left and right side members 22 , 24 are bent in a generally u - shaped configuration , although a generally v - shaped or l - shaped configuration would also fbm_ 1 _bm_ 1 _unction to enhance the lateral strength of members 22 , 24 . in addition to providing enhanced strength , the bent edges of left and right side members 22 , 24 provide convenient locations for attaching a front cover 30 , a rear cover 32 , and a top cover 34 ( shown in fig1 and 2 ) to body 12 . the sheet metal used to form members 22 , 24 , 26 , 28 of body 12 is preferably a 4 to 16 gauge steel sheet metal , more preferably a 6 to 14 gauge sheet metal , and most preferably an 8 to 12 gauge steel sheet metal . body 12 also includes a lateral support member 36 ( shown in fig3 ) which extends between and is coupled to right and left side members 22 , 24 . body 12 is preferably manufactured by unibody construction via permanently attaching members 22 , 24 , 26 , 28 , 36 to one another . as used herein , the term “ permanently attaching ” or “ permanently attached ” shall denote a manner of attaching two components to one another wherein the components cannot be detached without cutting or breaking the components apart . preferably , members 22 , 24 , 26 , 28 , 36 are welded to one another . it can be seen from fig1 through 3 that substantially all of the mechanical components of aerator 10 are supported on / by members 22 , 24 , 26 , 28 , 36 of body 12 . as opposed to conventional power aerators which typically employ a non - sheet metal structural frame with sheet metal components bolted thereto , the sheet metal components ( i . e ., members 22 , 24 , 26 , 28 ) of inventive aerator 10 are actually load - bearing structural members . as perhaps best shown in fig3 , wheels 14 are directly coupled to right and left side members 22 , 24 . as used herein , the term “ directly coupled ” shall denote a manner of coupling two elements to one another wherein the elements directly contact one another , as opposed to having an intermediate structure disposed between the two elements . right and left side members 22 , 24 each include a pair of reinforced openings that receive an axle of wheels 14 , thereby allowing wheels 14 to be rotatably coupled to right and left side members 22 , 24 . in this configuration , all of the weight of aerator 10 that is supported by wheels 14 is transferred to side members 22 , 24 . thus , side members 22 , 24 bear a substantial portion of the weight of aerator 10 . preferably , side members 22 , 24 bear a majority ( i . e ., more than 50 percent ) of the weight of aerator 10 . referring now to fig1 through 3 and 6 , front member 26 of body 12 extends between and is permanently attached to right and left side members 22 , 24 . motor 16 is directly coupled to and entirely supported on front member 26 . as perhaps best shown in fig6 , the front edge of front member 26 is bent in a configuration which provides significant structural reinforcement to front member 26 . the bent configuration of the front edge of front member 26 presents a sloped surface to which guard bar 20 can be rigidly and permanently attached . the rear edge of front member 26 is also bent in a generally l - shaped configuration to provide significant structural reinforcement to front member 26 . as perhaps best shown in fig2 and 6 , rear member 28 extends between and is permanently attached to right and left side members 22 , 24 . an upper portion of rear member 28 is bent in a generally v - shaped configuration to thereby provide significant structural reinforcement to rear member 28 . referring to fig3 , body 12 of aerator 10 houses and supports the internal mechanical components of aerator 10 . in particular , a crank shaft assembly 38 is directly coupled to , supported by , and extends between right and left side members 22 , 24 . referring now to fig3 and 4 , crank shaft assembly 38 generally includes a crank shaft 40 which is rotatably coupled to body 12 via bearings 42 , end plates 44 , and bolts 46 , 48 . crank shaft 40 includes a plurality of substantially upright axially spaced plates 50 which are aligned along the axis of rotation of crank shaft 40 . crank shaft 40 also includes a plurality of eccentric bars 52 , each disposed between a respective pair of aligned plates 50 . eccentric bars 52 are offset from the axis of rotation of crank shaft 40 . adjacent eccentric bars 52 are staggered relative to one another around the axis of rotation of crank shaft 40 . crank shaft assembly 38 also includes a drive shieve 54 which is rigidly coupled to crank shaft 40 via bolts 56 . as best shown in fig3 , a motor shieve 58 of motor 16 powers a drive belt 60 which , in turn , rotates drive shieve 54 and crank shaft 40 . referring now to fig3 through 5 , a plurality of tines 62 are rotatably coupled to eccentric bars 52 of crank shaft 40 . as best shown in fig5 , each tine 62 includes an end piece 64 , an elongated shaft portion 66 , and a connection portion 68 . connection portion 68 couples each tine 62 to a respective eccentric bar 52 . connection portion 68 includes a base 70 permanently fixed to shaft portion 66 and a cap 72 which can be removably coupled to base 70 via bolts 74 . base 70 and cap 72 are configured to cooperatively define an opening through which eccentric bar 52 can extend . a bushing 76 is preferably disposed within the opening cooperatively defined by base 70 and cap 72 and extends around a narrow portion 78 of eccentric bar 52 . narrow portion 78 of bar 52 and a wide portion 80 of bar 52 define a pair of shoulders 82 between which bushing 76 is disposed to thereby inhibit axial shifting of bushing 76 and tine 62 relative to eccentric bar 52 . bushing 76 allows eccentric bar 52 to rotate freely within the opening cooperatively defined by base 70 and cap 72 of tine 62 . a grease fitting / zerk 84 is provided in cap 72 to lubricate bushing 76 and reduce wear caused by the rotation of crank shaft 40 . thus , eccentric bars 52 and connection portion 68 cooperate to allow rotary motion of crank shaft 40 to be converted to reciprocal motion of tines 62 . end piece 64 of tine 62 is adapted to cut and remove plugs from turf when tine 62 is reciprocated into and out of the turf . end piece 64 defines an axially extending opening 86 which receives the cut plug from the turf . end piece 64 is preferably formed of a high - strength heat - treated metal that minimizes damage and wear to end piece 64 . end piece 64 also includes a male threaded portion 88 that cooperates with a female threaded end of shaft portion 66 and a lock nut 90 to thereby allow end piece 64 to be easily attached , removed , or replaced . referring now to fig3 and 4 , aerator 10 includes a swingable tine guide 92 that generally includes a pair of laterally spaced side supports 94 and a guide plate 96 . the lower ends of side supports 94 are rigidly coupled to opposite ends of guide plate 96 so that guide plate 96 extends between the lower ends of side supports 94 . the upper ends of side supports 94 are pivotally coupled to right and left side members 22 , 24 via bushings 98 . thus , swingable tine guide 92 is hingedly coupled to and supported by right and left side members 22 , 24 . guide plate 40 defines a plurality of elongated slots 100 . as perhaps best shown in fig3 , each slot 100 is adapted to receive a respective tine 62 . during reciprocal motion of tines 62 , guide plate 96 maintains tines 62 in a substantially upright position . referring to fig1 and 2 , handle assembly 18 includes a generally u - shaped handle bar 102 projecting rearwardly and upwardly from body 12 of aerator 10 . the upper end of handle bar 102 presents a generally horizontal portion which can be manually grasped by the user to facilitate manipulation of aerator 10 . handle assembly 18 also includes a cross bar 104 to which a clutch lever 106 and an aeration / transport lever 108 are pivotally coupled . clutch lever 106 and aeration / transport lever 108 can be shifted between a down position , wherein levers 106 , 108 are positioned closer to body 12 , and an up position , wherein levers 106 , 108 are positioned further from body 12 . levers 106 , 108 each include a generally u - shaped handle portion which receives the generally horizontal portion of handle bar 102 when levers 106 , 108 are in the up position . handle assembly 18 also includes a swingable lock 110 pivotally coupled to the generally horizontal portion of handle bar 102 . swingable lock 110 is operable to selectively lock either clutch lever 106 or aeration / transport lever 108 in the up position . clutch lever 106 is coupled to a clutch cable 112 via a spring 114 . clutch lever 106 is operable to pull on or increase the tension in clutch cable 112 when clutch lever 106 is shifted from the down position to the up position . aeration / transport lever 108 is operable to pull on an aeration / transport cable 116 when lever 108 is shifted from the down position to the up position . referring to fig1 and 3 , when clutch lever 106 ( shown in fig1 ) is shifted from the down position to the up position , clutch cable 112 causes a clutch shieve 118 ( shown in fig3 ) to shift from a position to an engaged position . when clutch shieve 118 is in the engaged position , clutch shieve 118 provides sufficient tension in drive belt 60 so that the rotation of motor shieve 58 causes rotation of drive shieve 54 via drive belt 60 . when clutch shieve 118 is in the disengaged position , the tension in drive belt 60 is decreased to a level which allows motor shieve 58 to rotate without rotating drive shieve 54 . the shifting of clutch shieve 118 between the engaged and disengaged position is facilitated by a clutch plate 120 which is pivotally coupled to right side member 22 of body 12 . a spring 122 can be coupled between clutch plate 120 and body 12 to thereby bias clutch shieve 118 towards the disengaged position . referring to fig6 and 7 , when aeration / transport lever 108 is shifted from the down position ( shown in fig6 ) to the up position ( shown in fig7 ), aeration / transport cable 116 causes tine guide 92 to shift from an aeration position ( shown in fig6 ) to a transport position ( shown in fig7 ). when tine guide 92 is shifted from the aeration position ( shown in fig6 ) to the transport position ( shown in fig7 ), tines 62 are pulled from a substantially upright position to a less upright position by guide plate 96 of tine guide 92 . when tine guide 92 is in the aeration position , end pieces 64 of tines 62 can extend below wheels 14 so that plugs can be cut and removed from the ground 124 via the generally upright reciprocal movement of tines 62 . when tine guide 92 is in the transport position , end pieces 64 of tines 62 are swung into a position where they can not extend below wheels 14 , thereby allowing aerator 10 to be rolled across the ground 124 without interference from tines 62 . referring to fig1 , 2 , 6 , and 7 , it can be seen that front , rear , and top covers 30 , 32 , 34 extend between and are releasably coupled to right and left side members 22 , 24 . covers 30 , 32 , 34 are preferably formed from sheet metal of substantially lighter weight than the sheet metal used to form members 22 , 24 , 26 , 28 of body 12 . preferably , covers 30 , 32 , 34 are formed from 14 to 24 gauge sheet metal , most preferably 16 to 22 gauge steel sheet metal . top cover 34 is hingedly coupled to front cover 30 via releasable hinge 126 . top cover 34 can be shifted between a closed position ( shown in fig1 , 2 , and 6 ) and an open position ( shown in fig7 ) by simply pivoting top cover 34 relative to front cover 30 at hinge 126 . latches 128 are provided to hold top cover 34 in the closed position . however , latches 128 can be easily released to allow top cover 34 to be shifted into the open position . when top cover 34 is in the closed position , top cover 34 covers a substantial portion of crank shaft assembly 38 . when top cover 34 is in the open position , crank shaft assembly 38 is substantially uncovered and can be accessed from above to thereby allow for the performance of routine maintenance , such as lubrication of tines 62 via grease fittings / zerks 84 . referring to fig1 and 8 through 10 , handle assembly 18 of aerator 10 can be shifted between an operating position ( shown in fig1 ) and a transport / storage position ( shown in fig1 ). handle assembly 18 includes a handle base 130 for hingedly coupling handle bar 102 to body 12 . handle base 130 includes a channel 132 , a collar 134 , and a hinge 136 . referring now to fig8 , when handle assembly 18 is in the operating position , handle bar 102 is locked in channel 132 by extending collar 134 around handle bar 102 and channel 132 . referring now to fig9 , to shift handle assembly 18 out of the operating position , collar 134 is slid upwardly off of channel 132 and onto handle bar 102 . handle bar 102 can then be pivoted upwardly and forwardly via hinge 136 . channel 132 defines an opening 138 which allows the distal end of handle 102 to extend therethrough when handle assembly 18 is shifted out of the operating position . referring now to fig1 , when handle assembly 18 of aerator 10 is in the storage / transport position , aerator 10 has a very compact configuration . preferably , the compact configuration of aerator 10 allows aerator 10 to be transported in the trunk of a standard mid - size or full size car . when handle assembly 18 is in the storage / transport position ( shown in fig1 ), it is preferred for the maximum height ( h ) of aerator 10 to be less than about 36 inches , more preferably less than about 30 inches , and most preferably less than 24 inches . when handle assembly 18 is in the storage / transport position ( shown in fig1 ), it is preferred for the maximum length ( l ) of aerator 10 to be less than about 48 inches , more preferably less than about 42 inches , and most preferably less than 39 inches . when handle assembly 18 is in the storage / transport position , it is preferred for the maximum width ( w ) of aerator 10 to be less than about 36 inches , more preferably less than about 30 inches , and most preferably less than 24 inches . the unibody construction of turf aerator 10 allows aerator 10 to have a significantly more compact configuration than conventional aerators using a frame - type construction . a significant advantage of the compact configuration of turf aerator 10 is the reduced wheel base ( i . e ., distance between the axes of rotation of the front and rear wheels ) of inventive turf aerator 10 . it is preferred for the wheel base of turf aerator 10 to be less than about 36 inches , more preferably less than about 24 inches , and most preferably less than 20 inches . referring to fig1 , it is preferred for aerator 10 to create a relatively dense plug pattern in the turf . preferably , the maximum distance ( a ) between plugs aligned along the direction of travel of aerator 10 is less than about 12 inches , more preferably less than about 10 inches , and most preferably less than 8 inches . preferably , the maximum lateral distance ( b ) between plugs perpendicular to the direction of travel of aerator 10 is less than about 8 inches , more preferably less than about 6 inches , and most preferably less than 4 inches . preferably , the density of the plugs in the turf is at least 6 plugs per square foot , more preferably at least 8 plugs per square foot , and most preferably between 10 and 15 plugs per square foot . the preferred forms of the invention described above are to be used as illustration only , and should not be used in a limiting sense to interpret the scope of the present invention . obvious modifications to the exemplary embodiments , set forth above , could be readily made by those skilled in the art without departing from the spirit of the present invention . the inventor hereby states his intent to rely on the doctrine of equivalents to determine and assess the reasonably fair scope of the present invention as it pertains to any apparatus not materially departing from but outside the literal scope of the invention as set forth in the following claims .

US-60408803-A

a therapeutic sling seat comprising a flexible material which is non - uniform in stiffness providing maximum contact surface area with the body of a person seated in the seat by spreading the forces away from high pressure areas using multiaxis tension forces . the seat material in tension adapts to the contour of the posterior of the seated person . by controlling the pressures on the ischial tuberosities , physical problems such as ulcers can be avoided .

referring now to fig1 and 2 , there is depicted a section of the torso of a person in a sitting position , with the skeletal structure shown in detail . in this position , the gluteus maximus 10 is supported by a horizontal frame member 12 such that the femur or thigh bones 14 are supported in a substantially horizontal position . also shown in fig1 and 2 are the pelvic or hip bones 16 , the sacrum 17 , the coccyx 18 , the trochanter 19 , the lumbar vertebrae 20 of the spine , the ilium 21 , the ischial tuberosities 22 , the pubic arch 23 , the bicep muscles 24 and the proximal thigh regions 25 . it is well known that one of the major causes of discomfort experienced by a sitting person is pressure . the weight of the upper body is concentrated at bony prominences or projections of the body , such as the ischial tuberosities 22 and coccyx 18 . pressure exerted over a long period of time can often cause mechanical damage to the body tissue , causing ulcers and discomfort in the area of the gluteus maximus 10 and the bicep muscles 24 under the weight concentrated at the ischial tuberosities 22 and , to some extent , the femur 14 , depending on how the body is situated in a particular chair . usually , a sitting person unconsciously adjusts his body position when discomfort is felt . however , for those handicapped persons who cannot feel pain or who are unable to adjust their body positions , tissue damage can very easily result . fig3 shows a basic sling seat construction . a flexible membrane 30 , which may be fabric or any similar material , is suspended between a pair of supports 32 which are attached along opposing edges 33 of membrane 30 . when a person sits upon that type of sling seat , membrane 30 deflects to form a concave surface between a catenary and the form of the body of the person sitting in the seat . the strength of membrane 30 is a function of the mechanical properties of its material and the method of its manufacture . in a traditional sling seat , the material for membrane 30 is usually chosen such that mechanical properties such as elasticity and friction are uniform in any location and direction on the material . in the sling seat of the present invention , however , the material of membrane 30 is selected such that a large surface contact area is obtainable by use of a thin and stretchable material which is non - uniform in stiffness . several suitable materials for use in the present invention are lycra and polartec . these fabrics provide a strong , yet very flexible , membrane by which the body weight of a person is entirely supported by multi - axis tension forces in the material , and allow the seat to essentially conform to the shape of the body and provide maximum surface contact area . thus , the area of the seat located under the ischial tuberosities 22 , where the pressure on the tissue is quite high in a traditional sling seat , conforms to the shape of the gluteus maximus 10 , thereby minimizing the pressure . fig4 shows an alternative embodiment of the basic sling seat construction of the present invention . the sling seat consists of a flexible membrane 34 having a forward edge 36 and a peripheral edge 38 . edge 38 consists of a pair of substantially parallel sides 38 a connected by a curved side 38 b . edges 38 a on each side are connected by a rear edge 40 . membrane 34 , which is constructed of a stretchable material non - uniform in stiffness such as lycra , is suspended along its peripheral edge 38 . in this embodiment , membrane 34 more completely conforms to the shape of the body of the person sitting in the seat than membrane 30 of the previous embodiment , as membrane 34 is supported on all sides except front edge 36 . fig5 shows an alternative embodiment of a sling seat manufactured using the principles of the seat shown in fig4 . membrane 50 , having an outer edge 51 , is constructed from the same material and in the same basic shape as membrane 34 . however , a peripheral membrane 52 is attached along the outer edge 51 of membrane 50 . membranes 50 and 52 can be constructed from the same type of flexible material having non - uniform characteristics , or it may be desirable for membrane 50 to exhibit a different rigidity characteristic than the peripheral membrane 52 , so that the weight bearing zone of the seat , specifically the area under the ischial tuberosities , will conform more closely to the body and more evenly distribute the pressure . in this embodiment , the inner membrane 50 can be selected to more closely fit the desired characteristics of elasticity for different persons , while maintaining a different peripheral membrane 52 with physical characteristics most ideally suited for attachment to a support frame . fig6 shows a variable thickness molded rubber sling seat which is constructed according to the principles of the present invention . in this embodiment , cushion 60 consists of a one piece molded rubber form having a front edge 61 and a u - shaped channel 62 positioned about its remaining periphery . a series of notches 64 are present along the rear of the periphery to enhance the flexibility of cushion 60 . a cylindrical frame 66 formed from a pair of tubular sections 66 a and 66 b coupled together at a hinge 67 is sized to fit within channel 62 of cushion 60 . hinge 67 allows frame 66 to be folded to a compact form . when cushion 60 is suspended from frame 66 in a suitable structure such as a wheelchair , cushion 60 deflects to conform to the shape of the body seated on it , as the rubber flexes in tension , accommodating the curvature of the body and minimizing the pressure by distributing the resultant forces evenly . referring now to fig7 another alternative embodiment of a sling seat 69 similar to that of fig3 is shown . a flexible membrane 70 has a forward edge 72 and rearward edge 74 and a pair of essentially parallel side edges 76 a & amp ; 76 b . membrane 70 is constructed of a flexible fabric which is non - uniform in stiffness , such as lycra or polartec . a pad 78 , which is preferably constructed of a thin layer of foam , is positioned adjacent the bottom side of membrane 70 . foam pad 78 can be manufactured using a range of thickness variations , along with various hole patterns , to further control the areas of contact with the seated person . a second membrane 80 , having a front edge 82 and rear edge 84 and a pair of essentially parallel side edges 86 and 86 b , is positioned beneath pad 78 . membrane 80 is also constructed from a flexible fabric which is non - uniform in stiffness . beneath membrane 80 is a second pad 88 constructed from a thin layer of foam . finally , a third flexible membrane 90 having a front edge 92 , and a rear edge 94 , and a pair of essentially parallel side edges 96 a and 96 b is positioned beneath pad 88 . the sling seat is formed by attaching side edges 76 a , 86 a , and 96 a together by conventional means , such as sewing , and also side edges 76 b , 86 b , and 96 b to form sling seat 69 . seat 69 is then suspended between a pair of supports by attaching edges formed at 76 a , 86 a , 96 a and 76 b , 86 b , 96 b . by varying the physical properties of each of the layers , a variety of seats with desired characteristics can be obtained . in this arrangement , membranes 70 , 80 , and 90 are always in tension , while the pads 78 and 88 held between the membranes are in compression . this seat forms a concave surface which surrounds the contour of the person seated upon it , as the membrane and foam layers are pliable . however , sometimes it is desirable to limit the deflection of the seat for support purposes . this is accomplished by the use of a stiffener layer 98 which may be sandwiched between the layers . stiffener 98 , which may be constructed from a polycarbonate plastic sheet such as lexan having a thickness of approximately 0 . 125 inches , contains a cutout section 99 which comfortably accommodates the ischial tuberosities and sacrum of the body , while stiffener 98 provides rigid support beneath the femurs to assist the person when rising from the seat . stiffener 98 also strengthens the seat for durability and handling . referring now to fig8 another alternative embodiment of a sling seat 100 similar to that of fig4 is shown . a flexible membrane 102 has a forward edge 104 and a peripheral edge 106 . edge 106 consists of a pair of essentially parallel sides 106 a connected by a curved side 106 b . in this embodiment , membrane 102 is constructed of a suitable sheet rubber , such as neoprene , which is non - uniform in stiffness . membrane 102 is suspended along its peripheral edge 106 to form sling seat 100 . within the interior of membrane 102 , a pair of apertures 108 are positioned to approximate the positions of the ischial tuberosities of a person sitting in seat 100 . extending radially from each of apertures 108 is found a series of small oval perforations 110 . the area 112 of membrane 102 , between apertures 108 serves to provide support for the pubic arch of the person seated in this seat , as the pubic arch is a sensitive part of the body and pressure on it must be carefully controlled by sufficient deflection downwardly to avoid distress . the essence of the design of the present invention is to achieve gentle contact without pressing with excessive force against the sensitive pubic arch . in the embodiment shown , perforations 110 are arranged in a series of concentric circles extending outwardly from apertures 108 . within each circle , perforations 110 are arranged in a sunburst pattern . perforations 110 are staggered from one circle to another . the sunburst pattern increases flexibility in the circumferential direction , thus enhancing radial expansion of membrane 102 . apertures 108 and perforations 110 allow membrane 102 to more comfortably accommodate the ischial tuberosities by more efficiently distributing the body weight . different patterns of perforations 110 can be employed to accomplish this distribution . fig9 shows an alternative embodiment of the seat shown in fig8 . seat 120 consists of a flexible membrane 122 having a front edge 124 and a peripheral edge 126 . edge 126 consists of a pair of essentially parallel sides 126 a connected by a curved side 126 b . membrane 122 , which is constructed from a suitable sheet rubber such as neoprene , contains a pair of recessed sections 128 which have been molded into membrane 122 ( see fig1 ). the area 132 of membrane 122 between sections 128 acts as a support for the pubic arch . recessed sections 128 each contain a series of perforations 130 which are arranged in a series of concentric circles . sections 128 , like apertures 108 shown in fig8 allow for the accommodation of the ischial tuberosities of a person seated in seat 120 . the concentric circular pattern can also be used in the embodiment shown in fig8 as it increases the vertical drop of membrane 102 , thus allowing membrane 102 to form cups to more comfortably support the ischial tuberosities . fig1 shows another alternative embodiment of a sling seat manufactured according to the present invention . seat 140 is similar to the embodiments shown in fig4 and 5 . however , seat 140 includes a membrane 142 located beneath the pubic arch of the seated person for the purpose of creating pressures and to also provide vertical lift to support the person &# 39 ; s weight . membrane 142 is supported along the periphery 144 at the rear of seat 140 and is affixed at an area 146 in the central region of seat 140 . preferably , membrane 142 is y - shaped and oriented such that the coccyx and ilium of the seated person is located in an area 148 between arms 142 a and 142 b of membrane 142 . also located on seat 140 are a pair of wedges 150 . wedges 150 , which are constructed of a stiff material , are located along periphery 144 on either side of membrane 142 and are constructed such that they are angled at preferably a 45 ° angle from periphery 144 toward the central region of seat 140 . wedges 150 are used to properly position the hip bones of the seated person forward and also to keep the sacrum away from the back edge of seat 140 , aiding in positioning the body in the seat for optimum comfort . arms 142 a and 142 b are anchored at the inner central edges of wedges 150 . fig1 shows an embodiment of the seat of fig3 in which no frame is used to support the sling seat . membrane 170 is preferably constructed from a flat sheet of a flexible fabric of a non - uniform stiffness , as is disclosed in fig3 having a pair of parallel edges 172 . edges 172 are attached to a cover 174 . cover 174 is preferably a canvas bag made from a fabric such as cordura . edges 172 are sewn along upper edges 176 of cover 174 such that membrane 170 is stretched across the top surface 178 of cover 174 . cover 174 is then stretched over a core 180 . to ensure proper tensioning of membrane 170 , elastic straps 181 are used to wrap under core 180 . core 180 is preferably composed of a layer of a semi - rigid composite foam such as l - 380xlpe foam . core 180 may also contain a series of perforations 182 to control its stiffness . this combination forms an “ invisible ” frame which helps to avoid injury if a person is not properly fitted or seated in the seat . the bony points of the body such as the coccyx , trochanter , and sacrum may come into contact with a rigid frame , thus causing possible severe injury . the seat taught in fig1 can avoid this possibility , which can be a serious problem with wheelchair patients . fig1 shows an embodiment of a seat manufactured according to the principles of the present invention . seat 200 consists of a top layer 202 having a curved front end 204 along with a pair of apertures 206 which allow for comfortable accommodation of the ischial tuberosities of the user . in addition , a plurality of circular apertures 208 may be located along the central area of layer 202 between apertures 206 and front end 204 to provide ventilation . layer 202 is preferably constructed from a soft foam , such as an open cell polyurethane . adjacent layer 202 in seat 200 is a layer 210 . layer 210 , which is essentially planar , contains a pair of apertures 212 which correspond to apertures 206 in layer 202 . surfaces 212 a of apertures 212 may be tapered inwardly , as can be seen in fig1 , to assist in proper location of the ischial tuberosities . layer 210 , which is preferably constructed from a semi - rigid foam such as voltek l200 cross - linked polyethylene , also contains a series of apertures 214 , similar to apertures 208 in layer 202 , which assist in providing ventilation for seat 200 . finally , layer 210 also contains a plurality of small perforations 216 which provide stiffness control for layer 210 at the proximal thigh and trochanter areas . a sheet rubber layer 218 is positioned adjacent layer 210 away from top layer 202 within seat 200 . layer 218 , which is preferably neoprene rubber , contains a plurality of apertures 220 corresponding to apertures 212 and 206 of layers 210 and 202 , respectively . layer 218 also contains a cutout section 222 located along each outer edge to accommodate the trochanters of the user of seat 200 . in addition , layer 218 contains a pair of extensions 224 a and 224 b , which , together with a support member 226 , which separates apertures 220 , form a y - shaped support , which is generally indicated at 228 . support 228 provides tension support and enhances weight distribution for the user of seat 200 by properly positioning the coccyx and ilium . layer 218 also contains a plurality of perforations 230 which provide stiffness reduction at the proximal thigh . situated below layer 210 is a median divider device 232 , preferably constructed from voltek l - 200 , which provides stability for the knees of the user of seat 200 by correctly positioning the legs of the user . device 232 is preferably adhesively affixed to the underside of layer 210 centered along its front edge . a foam cushion 234 is positioned adjacent sheet layer 218 on the side opposite layer 210 . foam cushion 234 is preferably a composite device , constructed from different foam materials having different physical properties which are selected to match the vertical deflection of seat 200 required for the different body parts of the user . in the embodiment shown in fig1 , cushion 234 is composed of separate foam sections 234 a , 234 b , 234 c and 234 d . section 234 a supports the ilium , section 234 b supports the mid - back , section 234 c supports the proximal thigh and trochanter regions , and section 234 d supports the legs of the user . cushion 234 contains an elliptical cutout opening on region 236 which preferably contains a surface 236 a which tapers outwardly from a lower surface 236 b in the direction of layer 218 . cushion 234 also contains a recessed area 238 along its rear edge which comfortably accommodates the coccyx of the user of seat 200 . finally , cushion 234 contains a plurality of apertures 240 similar to apertures 208 , 214 of layers 202 , 210 respectively which help to provide ventilation for seat 200 . adjacent cushion 234 is a stiffener plate 242 . plate 242 provides support which allows seat 200 to act as a sling seat when it is placed on an existing chair or support such as a wheelchair . plate 242 , which is constructed from a relatively thin rigid material such as plywood , a hard plastic , or a high impact polystyrene sheet , contains an elliptical opening 244 comparable to cutout region 236 in foam cushion 234 . plate 242 insures that cushion 234 stays flat and also supports the back section under the coccyx of the user of seat 200 . plate 242 also includes a series of apertures 246 which provide ventilation for seat 200 . in some instances where seat 200 will not fit properly into a wheelchair , a booster device 248 can often be employed to raise the hips of the user above the side rails of the wheelchair . device 248 , which is preferably constructed from a rigid material such as voltek l200 , contains an elliptical opening 250 which is comparable to openings 244 , 236 in plate 242 and cushion 234 respectively , which tapers in the same manner as cutout region 236 in cushion 234 . finally , booster device 248 may contain a plurality of raised protrusions 252 which fit within apertures 246 of plate 242 to ensure accurate positioning of booster device 248 in relation to seat 200 . fig1 a and b illustrate a removable cover system for use with the seat of fig1 . referring now to fig1 a , a removable protective cushion bag 260 is shown . bag 260 , which is preferably constructed from a water resistant and low - friction material such as cordura , contains a zipper 262 which is affixed along its rear end such that seat 200 can be easily inserted into bag 260 to protect it from any debris or liquids which may tend to soil seat 200 if unprotected . bag 260 also contains a series of apertures 264 to allow for air circulation and ventilation . affixed on the side of bag 260 is an indicator 266 , which when aligned with a mark on the wheelchair , enables seat 200 to be placed in exactly the same position on the wheelchair each time after it has been removed . fig1 b shows a variation of cushion bag 260 , designated as a slip cover 260 a , which can be used with the seat of the present invention . cover 260 a has a front flap 268 which is folded over seat 200 after it is inserted into cover 260 a and fastened to the underside using a removable attachment means such as velcro ( not shown ). cover 260 a also contains a rubber sheet 270 attached to the underside of the top of cover 260 a for added strength and durability . sheet 270 , which is preferably manufactured from neoprene , may also contain apertures 272 to accommodate the ischial tuberosities or any irregular bony points of the user of seat 200 . fig1 shows a separate cosmetic cover 274 which may be used as an additional cover over bag 260 or cover 260 a as further protection from the elements of the environment of use of seat 200 . cover 274 , which preferably manufactured from a strong , flexible , washable fabric such as lycra or polartec , is stretched over seat 200 and bag 260 or cover 260 a and is held in place by an elastic cord 276 , which holds cover 274 tightly in place about seat 200 . while this invention has been shown and described in terms of several preferred embodiments thereof , it will be understood that this invention is not limited to any particular embodiment and that many changes and modifications may be made without departing from the true scope and spirit of the invention as defined in the appended claims .

US-48889200-A

an improved radio - frequency based catheter system and method for ablating biological tissues within the body vessel of a patient comprises a radio - frequency generator for selectively generating high frequency energy in a deployable catheter having a rf co - axial transmission line with a hollow lumen , a rf antenna mounted on the distal portion of the catheter , and steering control lines in the lumen of the transmission line for steering catheter while being inserted into the body vessel and for deflecting the rf antenna to accommodate the contour of the body vessel where tissue ablation is needed . the rf generator having variable output frequency is adapted to generate and communicate rf energy to the rf antenna that minimizes reflected energy from the antenna - tissue interface . in application , the rf antenna establishes line of contact with the body vessel conformable to its internal contour to prescribe the precise tissue ablation pathway despite body vessel movements . the rf antenna is steered by the steering control lines to establish its body vessel conformation . the catheter system is energized and system senses the reflected rf power relative to its output power and adjusts the frequency of the power output to effect impedance match between the transmission line of the system and the tissue ablation load .

the present invention involves a radio - frequency based catheter system for the ablation of biological tissues , as shown in fig1 . in particular the present invention is adaptable to ablate tissues located in the internal vessels of living mammals by way of a radio - frequency ( rf ) antenna that is incorporated as part of a catheter . the catheter is insertable within the internal lumens or body vessels of such mammals and the rf antenna is placed in proximity of the tissues to be ablated where rf energy is applied to effect the tissue ablation . the invention provides a means for generating a train of rf energy pulses , especially in the microwave frequency range , which are delivered via an electrical transmission line to the rf antenna . the frequency of the rf energy pulses can be selectively varied according to the electrical characteristics of the electrical transmission line and the load impedance associated with the tissue ablation . the invention also incorporates a means for sensing the forward and the reflected powers associated with the microwave frequency energy pulses , on which a reflected - to - forward power ratio is defined . adjusting the output frequency of the energy pulses of the rf generator to minimize the reflected - to - forward power ratio , the present invention fine - tunes the impedance of the system energy output to substantially match that of the ablation load and delivers the ablation energy to where it is needed . thus , the present invention provides not only the means for generating and delivering rf energy to the rf antenna for tissue ablation , but also a means to maximize the operational efficiency of the rf antenna , which reduces the risks of overheating the electrical transmission line . with reference to fig1 a and 1b , a radio - frequency (“ rf ”) ablation catheter 100 including a shapeable antenna apparatus 110 constructed in accordance with an embodiment of the present invention is shown . the catheter 100 is adaptable for insertion into a body vessel of patient and the shapeable antenna apparatus 110 includes a radio - frequency antenna for delivering electromagnetic energy to a treatment site . the catheter 100 will first be described before describing the shapeable antenna apparatus 110 of the present invention . the catheter 100 has a flexible elongated tubular body 120 with a proximal portion 130 and a distal portion 140 . one or more intracavity lumens 150 ( fig3 a , 3b ) extend from the proximal portion 130 of the catheter 100 to the distal portion 140 . located at the proximal portion 130 of the catheter 100 is a handle chassis 160 for housing necessary steering and positioning controls , as will be described in further detail below . incorporated at a proximal end 160 of the catheter 100 is a coupling 170 for connecting the catheter 100 to one or more electronic devices such as an rf generator and controller ( not shown ) in support of the ablation procedure . the dimensions of catheter 100 are adapted as required to suit the particular medical procedure , which are well known in the medical art . in a preferred embodiment , the catheter 100 is used to ablate cardiac tissue ; however , the catheter 100 may be used to ablate other types of body tissue . the tubular body 120 of the catheter may be generally constructed of a polymer material that is bio - compatible within the body vessel environment . examples of these materials include , but not by way of limitation , pebax from autochem germany , polyethylene , polyurethane , polyester , polyimide and polyamide , with varying degrees of radiopacity , hardness and elasticity . the catheter 100 may be formed with a plurality of segments using one or more of the aforementioned materials such that the catheter body 120 is progressively more flexible toward its distal end . the segments may be joined together by thermal bonding , butt joint , or adhesive bonding . braiding reinforcement can also be added to the circumferential surface of tubular body 120 to attain the desirable level of stiffness and torsional strength for the catheter 100 . this allows the catheter 100 to advance and negotiate through the body vessel of a patient , and to enable torque transfer along the length of the catheter from the proximal portion to the distal portion . with reference additionally to fig3 a and 3b , the distal portion 140 of catheter body 120 may include a softer polymer compound than the proximal portion 130 , with little or no braiding , to provide the desired flexibility to accommodate distal deflection and shaping of the shapeable antenna apparatus 110 . deflection and shaping of the shapeable antenna apparatus 110 may be implemented through the use of a pre - shaped deflection member 180 and a deflection regulating member 190 . the pre - shaped deflection member 180 and / or the deflection regulating member 190 may extend from the handle chassis 160 to the distal portion 140 of the catheter body 140 . the pre - shaped deflection member 180 and / or the deflection regulating member 190 may be proximally fastened to deflection control mechanism 220 or thumb slide 200 ( fig1 a , 1b ), which may be slidably engaged along a axial slot of the handle chassis 160 . axial movement of the thumb slide 200 along the axial slot , together enables a physician to shape or deflect the shapeable antenna apparatus 110 between a straight configuration ( fig1 a ) and a deflected , shaped configuration ( fig1 b ), or any configuration therebetween . a frictional capture mechanism ( not shown ) may be incorporated in the thumb slide 200 to maintain the grip position in the axial slot . many such means are commercially available . examples of such means include set - release , pressure switch or self - locking mechanisms . [ 0035 ] fig2 a and 2b illustrate an rf ablation catheter 210 similar to the rf ablation catheter 100 described above , but with an alternative embodiment of a deflection control mechanism 220 for shaping or deflecting the shapeable antenna apparatus 110 . the deflection control mechanism 220 may include a rotatable collar 230 that circumferentially surrounds and is rotatably coupled to a handle shaft 240 of the handle chassis 160 to control axial movement of the pre - shaped deflection member 180 and / or the deflection regulating member 190 . the handle chassis 160 may house a translation mechanism that translates rotation movement of the collar 230 to axial movement of the pre - shaped deflection member 180 and / or the deflection regulating member 190 . rotational movement of the collar 230 relative to the handle shaft 240 enables a physician to shape or deflect the shapeable antenna apparatus 110 between a straight configuration ( fig2 a ) and a deflected , shaped configuration ( fig2 b ), or any configuration therebetween . [ 0036 ] fig3 is a schematic block diagram of a radio frequency based catheter system according to an embodiment of the invention , illustrating the electrical and signal components of the system . catheter system 300 has a power switch 300 , power supply system 310 , micro - controller system 320 , rf signal generator or oscillator 330 , rf amplifier 334 comprising a pre - amplifier 331 , rf bidirectional coupler 336 , ablation catheter 340 , control input 350 , display 360 , and alarm output 370 . the ablation catheter 340 includes a catheter steering and deflection mechanism ( not shown ), rf transmission line 342 , and rf antenna 343 . the rf based catheter system 300 is powered by ordinary alternating current power and it could be adapted to be powered by an appropriate direct current source as well . the power switch 300 connects the electrical power to the system power supply 310 . the system power supply provides primary patient safety isolation and synthesizes various direct current voltages necessary to operate the apparatus to effect tissue ablation . the microcontroller 320 , which is microprocessor based , provides for user input , displays for inputs and outputs , and sets system alarm conditions . microcontroller 320 also monitors and controls rf power synthesis and communication to the rf antenna 343 and ablation tissue . as shown in fig3 the microcontroller 320 monitors and controls rf signal oscillator 330 , which receives power from the power supply system 310 . rf signal oscillator generates a continuous rf frequency wave signal 332 at a power level and frequency determined and controlled by micro controller 320 . in the embodiment of the present invention , the rf signal oscillator 330 is electrically coupled to the power amplifier 334 . the power amplifier 334 includes a preamplifier 331 , which initially amplifies the wave signal 332 from the rf generator and produces a first train of relatively low energy pulses . after amplification by rf amplifier 334 , the energy pulses are then delivered via a transmission line 342 to an rf antenna 343 , which as been placed in the proximity of the tissue to be ablated . as shown in fig2 the bidirectional coupler 336 is electrically interposed between the amplifier 334 and transmission line 342 . the coupler samples the relatively low energy forward pulses along the transmission line and the energy pulses reflected from the target ablation tissue and uses the signal samples as feedback to the micro controller 320 . the feedback mechanism provided by sampling the signal at the coupler 336 is useful for scaling back the amount of reflected energy . too much signal reflection could potentially destroy sensitive system 300 components or cause patient injury . electrically in communication with the bi - directional coupler 336 , the micro - controller 320 monitors the forward and reflected energy pulses . micro - controller 320 then defines a ratio for the reflected and forward energy pulses . in one embodiment , this ratio comprises a voltage standing wave ratio ( vswr ), computed as : where γ 0 represents the load reflection coefficient computed using the appropriate boundary conditions along rf transmission line 342 . a low ratio would indicate that most of the energy generated by the system is applied to the load for ablation , and is characteristic of having achieved matched impedance between the apparatus and the ablation load . a high ratio , on the other hand , would indicate that a significant amount of the energy generated by the system is being reflected , and is characteristic of a high degree of return loss , or leakage , resulting from a poor impedance match . to the extent that the impedance of rf transmission line 342 is affected by the pulse 332 frequency , the present invention provides a means to enable the change of frequency in the power output of the system such that both the line impedance and the load impedance will be matched . the means for sensing ( i . e ., the bidirectional coupler , in one embodiment ) and the means for adjusting comprise a means for adjusting rf signal source 330 and rf power amplifier 334 in response to the means for controlling ( i . e ., the micro controller 320 ) to match the transmission line impedance to the load impedance . for example , if the ratio indicates that too much energy is being reflected ( e . g ., vswr is high ), the micro controller 320 adjusts the frequency of the rf signal 332 generated by the oscillator 330 to effect a reduced value in the ratio of the reflected and forward energy pulses . such a reduction in the power ratio effects impedance matching between the transmission line and the ablation load . an acceptable amount of return loss would depend upon the application . however , since a perfect impedance match is never achievable , micro controller 320 can allow for the user to adjust the frequency such that the ratio drops below some threshold value , such as 1 . 4 : 1 . because load impedance can vary widely among tissue types and can vary according to the quality and quantity of fluids surrounding the tissue , such as in a blood - filled cavity or chamber , the means for controlling supports a broad range of frequency adjustment settings to enable flexible deployment of system 300 in the field . having achieved a match in the impedance , the inventive apparatus adjusts the power amplifier 334 to produce the train of relatively high energy pulses , which will be delivered via the transmission line to the rf antenna to effect tissue ablation . in one example of the present invention , the power lever generated for ablation process was approximately 60 watts . in addition to providing monitoring and adjusting functions over the frequency of the rf pulses , the micro - controller 320 also communicates the various signals and indicators to a user such as electro - physiologist . the system supports manual override in the rf frequency , output power , and setting the ablation duration . in a typical configuration , the control input 350 of the present invention may be equipped with a multi - line display , a set of up and down keys for adjusting output power level and ablation period , a ablation on / off key for activating ablation processes , and a mode / setup key for changing display mode and / or configuring an i / o port . the output power level of the rf amplifier 334 is monitored continuously during ablation processes . the rf bi - directional coupler 336 provides the ability to sample both forward and reverse power levels at attenuated levels that are electrically connected to the micro - controller assembly . the micro - controller assembly compares the two signals and adjusts both the signal source and the preamplifier / power amplifier gains to achieve lowest reverse - to - forward power ratio . the rf based catheter system 300 monitors and controls the microwave frequency and power output within typical range of 900 mhz to 930 mhz to minimize reflected - to - forward power ratio . the rf antenna 343 is typically manufactured and tuned to 915 mhz in the saline solution closely approximating biological tissue and fluid filled animal body vessel to be ablated . upon entering the body vessel and coming in contact with the biological tissue to ablation , the electrical dimension of the rf antenna 343 may slightly altered temporary to cause reflected power to increase . increased reflected power reduces overall power available for irradiation and therefore , reduces efficient tissue ablation . if the reflected power is left unchecked and increases greatly , local heating of the rf antenna 343 may occur and produce unwanted ablation affects . [ 0050 ] fig4 is a flow diagram of a method for biological tissue ablation according to an embodiment of the invention . such a method can be used to program the instruction set of microcontroller 320 in order to carry out the ablation procedures described herein . the process begins after the system is powered on by a user , usually by engaging power switch 301 . in step 401 , the system normally runs a battery of initialization routines in order to establish system integrity . self - test can comprise , for example , displaying a logo on a display and checking system rom for appropriate hardware . in condition block 403 , the process branches to a system error if the power - on self test fails . in one embodiment , if the self - test failed on power - on , then an alarm will sound . if the self - test passes in condition block 403 , then ablation parameters can be set either automatically , or manually by the electro - physiologist in step 405 in condition block 405 , if ablation has not been successful after a period of applying rf energy to the region of interest , then a control signal can be sent back to the user or to microcontroller 320 permitting the appropriate ablation parameter adjustment ( step 407 ). in step 409 , ablation continues under constant monitoring conditions , so that an appropriate adjustment can be made to the frequency of oscillator 330 , such as in the case that the measure of reflected - to - forward power is too high . several parameters can be monitored in real - time to insure that critical system thresholds are not exceeded . for example , power output in step 411 can be monitored as well to insure that the prescribed amount of ablation exposure is provided . too much exposure , and unwanted results , such as ablation of surrounding benign tissue , could result . the radio - frequency based catheter system and method for ablating biological tissues can be adapted to a variety of medical uses . the description and drawings contained herein represent the presently preferred embodiment of the invention and are , as such , a representative of the subject matter which is broadly contemplated by the invention . the scope of the invention fully encompasses other embodiments that may become obvious to those skilled in the art , and the scope of the present invention is accordingly limited by nothing other than the appended claims .

US-63732503-A

a flexible screen closing an interior wall opening in a building , has a series of hanging columns made of adjacent tubes of flexible material , each tube having discrete pieces of solid filler material arranged in series along the length of the tube , and each tube having rings around the exterior thereof at spaced locations along the length of the tube , to constrict the tube at those locations so that the tube is sufficiently flexible to permit movement of people through the screen for passage from one room to another .

for the purposes of promoting an understanding of the principles of the invention , reference will now be made to the embodiment illustrated in the drawings and specific language will be used to describe the same . it will nevertheless be understood that no limitation of the scope of the invention is thereby intended , such alterations and further modifications in the illustrated device , and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates . referring now to the drawings in detail , a stationary wall 11 in a building has a doorway 12 therein which includes the door jambs 13 and 14 at the left and right - hand sides of the doorway and the header 16 at the top . the screen of the present invention is hung in the doorway by means of hanger bar 17 ( fig2 ) which is secured in the header by wood screws 18 driven into the header 16 . the bar 17 may be quarter - round material as shown , or may be other decorative shapes , as desired . an identical piece 19 is mounted at the front of the piece 17 , and may be screwed into the hanger bar 17 by screws 21 . the columns comprising the screens are made of individual tubes , typically of fabric . velvet is an example . more specifically , for column 22 , it is made of a velvet fabric which is initially a very long strip , the length being determined by the overall height of the screen to be used to close the doorway . 7 . 5 feet is an example . with the fabric inside out , the longitudinal edge portions adjacent edges 23 and 24 ( fig5 ) are stitched together . then one end is stitched together . then the tube is turned inside out as by placing a suitable rod ( broomstick , for example ) against the stitched end and pushing it through the material so as to turn it inside out . then filler blocks are inserted . for example , the filler block 26 is inserted at the open end of the tube and pushed down to the bottom 27 . then a constricter or garter is installed at 28 . in this example , the garter is a brass ring 29 . this can be a solid ring slipped along the collapsed tube from the open end to a point at the top of the filler block 26 . alternatively , it could be a split ring clamped around the tube material 23 at 28 , until the ends of the ring abut each other . then a second filler block 31 is installed in the same manner as the first until it stops at the constriction 28 where the garter ring is located . then another garter ring 32 is installed . then another block 33 is installed . this process is continued until the tube is essentially full when the last filler block 34 ( fig2 ) is installed near the top of the tube . at the top of this block , the tube material 23 is flattened at 36 and may be stapled to the hanger bar 17 as at 37 . additional stapling or nailing may be done for the portion of the tube that is folded over the top of bar 17 at 38 . this provides additional security in the hanging of the tube on the hanger bar 17 . the successive columns in the series along the length of the hanger bar can be made in the same way . as described above , after stitching the longitudinal edge portions of the strip 23 together , which provides the seam 25 , the end is stitched together . it will be observed that , where the filler blocks are circular as shown in fig5 some cutting of the end of the material , before stitching together , is desirable so that there may be at least four neat appearing seams such as 39 ( fig3 ) in a cross configuration at the bottom , and which are virtually undiscernible when the material is turned inside out and the bottom block 26 is installed . similarly , although the seam 25 is shown located at one face of the screen for ease of illustration , it is preferable that it be located at the side so that it faces an adjoining column . therefore , even though the seam may be unnoticable in the material being used for the tube , it is further obscured by being immediately adjacent the next successive column in the series . also , as is apparent in fig1 the successive columns in a series may have the constrictions alternately spaced for a particular desired decorative effect , using the shorter filler blocks such as 31 at appropriate locations . fig4 shows a variation where it is desired to provide a protective cup at the bottom of the screen . in this example , the filler block 41 has a centrally located longitudinally extending aperture 42 therein . a cup 43 of metal or other durable and decorative material has a central aperture 44 therein receiving the head 46 of a flathead screw 47 extending up through the block 41 and out the upper end thereof . a flat washer 48 is mounted on top of the block and a nut 49 is secured to the screw . the installation of this cup can be done immediately after the installation of the block 41 and before the mounting of the garter 51 . it is done by inserting the screw through the cup and through the block 41 . the washer and nut are dropped through the open upper end of the tube onto the top of block 41 . since the block 41 snugly fits the tube material 23 , there is no chance that the washer or nut will slide down to the bottom . instead , they can be located on the nut manually , because the fabric , being flexible , permits feeling them and positioning them on the screw , whereupon the nut can be held by the fingers gripping it through the fabric as the screw is turned from the bottom with the screwdriver . then the garter ring is installed and the rest of the blocks and rings are installed and the column is attached to the hanger bar . from the foregoing description , it should be recognized that the invention can be made using a variety of materials . fabric has been mentioned . velvet is a good example . leather or decorative vinyls might also be used . the filler blocks may be wood but are more likely to be of a lightweight plastic . a good quality foamed plastic can be used . it is intended that the filler block , whether it be circular in cross section as shown in fig5 or of some other cross sectional shape , be sufficiently rigid that it maintain that shape when installed in the tube . it is also intended that where the filler block is elongated , its longitudinal axis remain straight at all times . in other words , the block itself is to be rigid enough so as not to be bent . the flexibility of the screen is provided by the spaced constrictions along the length of each of the columns , and not within any section where the filler is located . while the columns may be made virtually any length , and the cross sectional dimension can have various sizes and shapes , a typical size for the columns having circular cross section is an overall diameter of less than 2 . 5 inches , with the constrictions in such an example having a diameter of less than 1 . 75 inches , the objective being to have a combination of suitable flexibility at the constrictions consistent with a pleasing esthetic effect . the screen is particularly useful in openings between building interior rooms . with selection of suitable materials adapted to environment and desired decorative effect , the screen may be used in exterior doorways , in window openings and other locations . while the invention has been illustrated and described in detail in the drawings and foregoing description , the same is to be considered as illustrative and not restrictive in character , it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected .

US-16777388-A

a magnetic resonance imaging magnet in combination with a mobile patient - positioning device , including a patient support and a method of using same for positioning patients for mri scanning . the patient support is rotatable through a range of orientations from a horizontal to a vertical position , including being lockable at any oblique angle with respect to the horizontal . the patient disposed on the patient - positioning device in a predetermined orientation can then be moved horizontally into and out of a patient - receiving space in the mri magnet at the predetermined angle or orientation . a preferred embodiment includes a plurality of patient - positioning devices in which a series of patients can be placed in a ready state while one patient is within the patient - receiving space . as an alternative embodiment , the patient may be moved vertically into position for mri scanning by way of an elevator which is actuatable from the floor below the patient receiving space . this elevator also may be used in combination with the patient - positioning device . preferred embodiments facilitate mri guided surgery and other procedures performed while the patient is being imaged .

apparatus in accordance with one embodiment of the present invention , as shown in fig1 - 8 , includes a magnetic resonance imaging magnet 9 which may include a ferromagnetic flux return frame or yoke 10 defining a pair of opposed poles 12 projecting towards one another along a horizontally - oriented pole axis 14 ( fig2 ) and defining a patient receiving space 16 . flux generating means such as permanent magnets associated with frame 10 , superconducting coils encircling portions of the flux return frame 10 or , most preferably , resistive electrical coils 18 encircling portions of the frame 10 are provided . as illustrated , the resistive coils 18 encircle the frame 10 adjacent poles 12 . the structure of the c - shaped magnet may be as illustrated and described in co - pending , commonly assigned u . s . patent application ser . no . 07 / 993 , 072 filed dec . 18 , 1992 , the disclosure of which is hereby incorporated by reference herein . the magnet defines an open direction of patient entry as indicated by arrow 20 in fig1 allowing movement of a patient into patient receiving space 16 . the magnet is supported on a floor 22 of a building , vehicle or other structure by a set of columns 24 , so that the pole axis 14 and the patient - receiving space 16 are disposed above the floor 22 . one or , more preferably , several mobile patient - positioning devices 30 are provided . one such device is shown in fig3 - 8 . each patient - positioning device is movable relative to the magnet 9 independently of the other patient - positioning devices . thus , the preferred patient - positioning de vice 30 illustrated includes a frame 32 mounted on wheels 34 so that the device 30 , with a patient thereon can be moved into and out of the patient - receiving space 16 of the magnet 9 by an operator manipulating the device 30 with a handle 36 . the device 30 further includes a patient support 38 movably mounted to frame 32 as by a swingable pivot and lock arrangement 40 and linear movement device 42 . patient support 38 can be swung or adjusted between the horizontal position depicted in fig3 and a vertical position depicted in fig4 and also can be moved to tilted positions ( see fig6 ) at which the patient support 38 makes oblique angles with the horizontal . as an example of such an oblique angle , a patient may be placed in a trendelenburg position and or a counter - trendelenburg position . generally , a trendelenburg position is one where the patient support 38 is tilted from horizontal such that the patient &# 39 ; s head is below his or her feet in relation to the horizontal . this position is useful during cardiac surgery and scanning in the heart region . a counter - trendelenburg position is one where the patient &# 39 ; s head is above their feet . linear movement device 42 is arranged to move the patient support relative to pivot and lock arrangement 40 and frame 32 . when the patient support 38 is in the vertical position ( fig4 ), the linear movement device 42 can move the patient support 38 upwardly and downwardly . also , when the patient support 38 is in a vertical position , the support can be rotated about a vertical axis . when the patient support is in the oblique position , linear movement device 42 can move the patient support in the oblique plane . for example , linear movement device 42 may include a fluid - operable piston and cylinder arrangement . in place of wheels 34 , frame 32 can be equipped with slidable skids or air cushion supports for raising the frame slightly off the floor to permit movement . the frame 32 of the mobile patient - positioning device 30 also may be supported for movement towards and away from the magnet on an overhead monorail or other elevated rail arrangement . finally , device 30 may be automatically moved into and out of the patient receiving space by means of an automatic control device ( not shown ). the patient support 38 is further equipped with a retractable or swingable foot stand 44 ; a retractable seat 46 and retractable hand grips or arm rests 48 . a patient may be positioned on patient support 38 and brought to essentially any desired orientation relative to frame 32 and relative to the floor 22 or a horizontal position . for example , a patient may be positioned on support 38 in a standing position , with support 38 in a vertical or near vertical orientation and with the patient standing on foot rest 44 . preferably , the patient leans on support 38 while standing . the patient also may be positioned on seat 46 . alternatively , the patient may lie on the surface of patient support 38 . the components of the mobile patient - positioning device 30 are formed from non - metalic materials such as , for example and , preferably , polymers or other dielectric materials . device 30 does not substantially interact with the magnetic fields produced by magnet 10 and thus does not impair the magnetic resonance imaging process . a patient may be positioned on one mobile patient - positioning device 30 and brought to the desired position and orientation while that device 30 is remote from the magnet 9 and while the magnet 9 is being used to image another patient , preferably held on another , similar mobile patient - positioning device . thus , the time consumed in positioning and orienting the patient does not detract from the productivity of the scanner , including magnet 9 . the magnet 9 is only occupied by a given patient during the time required to conduct the actual scan of the patient and during very brief intervals required to wheel the mobile patient - positioning device 30 , with the patient prepositioned thereon , into the patient receiving space 16 . to assure accurate positioning of the mobile patient - positioning device relative to the magnet 9 and hence assure accurate positioning of the patient , the floor 22 or the magnet frame 10 itself may be equipped with rails or guides or tracks which mate with corresponding features on the mobile patient - positioning device 30 . for example , wheels 34 may be grooved or flanged , and may run on rails or grooves in floor 22 . a first set of rails , guides or tracks may run substantially in the direction of the patient entry 20 . a second set of rails and the like may run substantially perpendicular to the first set . a second patient may be disposed on a patient - positioning device which is itself positioned to run on the second set of rails . in this manner , the second patient is positioned in a ready state , waiting to be moved into position for mri scanning . preferably , the first and second set of rails are positioned adjacent each other on the floor so that they intersect and allow for movement from one set to the other . the ability to position each patient in essentially any orientation allows scanning while the patient is in essentially any posture . this improves the realism of the scanned image and allows detection of posture - dependent problems . for example , a patient having difficulties with a knee joint can be imaged while the joint is bearing weight , with the patient in an essentially standing position . also , internal organs can be brought to the positions which they occupy while the patient is standing or seated . for example , it is advantageous to perform intestinal surgery on a patient when that person is in a vertical position . the ability to move the patient - positioning device upwardly and downwardly allows scanning of essentially any part of the patient . typically , the pole axis 14 ( fig2 ) is about 5 - 6 feet ( about 1 . 5 - 2 . 0 meters ) above floor 22 so that the head of a standing adult patient can be positioned at or near the pole axis . the ability of the mobile patient - positioning device 30 to elevate the patient , by action of linear movement device 42 allows other parts of the patient to be brought into alignment with the plural axis and hence to be imaged . the magnetic flux return frame or yoke 10 and the coils may be hidden from the patient by a false or cosmetic wall surrounding the same . as illustrated in fig9 and 11 , a similar c - shaped magnet 61 may include a built - in patient elevator 62 . the c - shaped magnet 61 may be positioned above a false floor 64 so that the patient may walk onto the elevator platform 66 while the platform 66 is aligned with the false floor 64 and the elevator platform 66 may then be raised or lowered to position the patient at the appropriate height relative to the magnet 61 and relative to the plural axis 14 . the two approaches described heretofore may be combined . thus , a mobile patient - positioning device 30 as illustrated in fig1 - 8 may be used with a fixed patient elevator 60 , so that the patient is positioned at the appropriate orientation on the mobile patient - positioning device . the device 30 is rolled onto the elevator platform 66 . the elevator platform 66 is then raised and lowered as necessary . in a further alternative , a fixed elevator need not incorporate a platform , but instead may be arranged to engage the frame 32 of the mobile patient - positioning device 30 , as by a fork or rods on the elevator 62 engaging in holes on the frame of the mobile patient - positioning device 30 . a preferred method of mr scanning of a patient with the long axis of the body in a vertical orientation would proceed as follows : with the patient support 38 in a vertical position as shown in fig4 the patient steps onto the retractable foot stand 44 . during this stage of the method , the patient support 38 is maintained at a convenient height for the patient to step onto the foot stand 44 from the floor 22 . although foot stand 44 is depicted as slightly above the level of the floor in fig4 the patient support 38 optionally may be lowered to position the foot stand level with the floor , thereby further facilitating access by infirm patients . the patient is then positioned and made comfortable . this step may include the patient grasping the retractable hand grasps or arm rests 48 . the patient also may lean on support 38 while standing . in addition , additional cushioning , such as pillows and inflatable supports , may be provided to increase the patient &# 39 ; s comfort . the patient - positioning device 30 is then moved into the patient receiving space 16 where the additional positioning of the patient up or down is achieved by means of the linear movement device 38 . this aspect of patient - positioning will locate the anatomical region of interest for mr scanning at the proper position in the patient receiving space 16 . at this point , the mr scanning data acquisition will proceed . following completion of mri data acquisition , the patient - positioning device 30 is removed from the patient receiving space 16 . in this relocation step , the patient support 30 may be lowered or raised to a convenient height for the patient to step off of the foot stand 44 onto the floor 22 . this may be accomplished before or after removing the patient - positioning device 30 from the patient receiving space 16 . the patient may then dismount the patient - positioning device 30 . there are variations of this preferred embodiment which should be evident in light of the foregoing description . first , the patient , when standing on the retractable foot stand , may be oriented in any direction as may be defined by rotation along the long axis of the patient &# 39 ; s body . to this end , the pivot and lock arrangement 40 may be provided with additional pivots , gimbals or other mechanisms which allow patient support 38 to pivot relative to frame 32 about its long axis l or another axis parallel thereto , and / or to pivot about a vertical axis v relative to the frame ( fig6 ). alternatively or additionally , the wheels 34 or other mobile support device supporting the frame 32 may include pivotable casters or other devices which allow the frame to be turned around a vertical axis relative to the floor 22 . also , slight deviations or tilts of the patient &# 39 ; s body , and of the long axis l from the true vertical orientation may be used . finally , if the objective of the mri procedure is to scan an anatomical region of interest in the upper portion of the patient &# 39 ; s body in a vertical orientation , the patient may be seated on retractable seat 46 . in the preferred embodiment , after stepping onto the patient - positioning platform , the patient would sit on the retractable seat 46 prior to proceeding with the mri scan . in yet another variant , the patient - positioning device 30 may remain fixed within the patient - receiving space 16 , and the patient can walk into the patient - receiving space and stand on or against the patient support 38 . for example , the patient may step onto the foot stand 44 . alternatively , the patient can sit on seat 46 . if the equipment is to be used only in this manner , frame 32 can be fixed relative to the mri magnet and / or integral therewith . the configuration of the magnet allows convenient walk - in patient entry . mri is a useful modality for monitoring the progress of surgical procedures . a further aspect of the present invention extends this utility in surgical applications , as can be seen in fig1 . a surgeon and associated medical personnel as necessary to perform a surgical procedure , can occupy a medical personnel area 50 , between the legs of the c - shaped frame and / or in the area 52 immediately outside of patient - receiving space 16 . with the patient support 38 in a horizontal position , the patient is positioned in the magnet gap area , followed by the desired height adjustment as described above . the surgeon is then able to perform a surgical procedure , with the guidance of mr imaging . such an embodiment is particularly advantageous for surgery performed on either end of the body including areas such as the head , neck or the foot ankle and knee in the case where the patient is positioned in the magnet feet - first . as an alternative embodiment , the medical personnel area may be located outside the magnet and proximate the magnet gap area , providing comparable access to the patient for surgery . the ability to position a patient in a vertical orientation , as by positioning patient support 38 in vertical orientation with the patient either standing or sitting and perform mr imaging during a surgical procedure , enables novel surgical methods to be employed . for example , it would be advantageous to have the ability to perform intestinal or other abdominal surgery on a vertically oriented patient . additional supports may be used to stabilize the patient when in a vertically orientated position . these supports preferably are pillows or inflatable cushions . also , with the patient in a sitting position , a surgeon may perform knee surgery on the knee in a flexed position if desired . in these embodiments , the surgeon and associated medical personnel may operate from either medical personnel area as described above . apparatus in accordance with another embodiment of the present invention , as shown in fig1 - 14 , includes a magnetic resonance imaging magnet 109 which may include a ferromagnetic flux return or yoke 100 . in this embodiment , the yoke 100 is submerged under a false floor 164 . the magnet 109 is substantially the same as the magnet 9 shown in fig1 - 8 , wherein the yoke 100 defines a pair of opposing poles 112 projecting towards one another along a horizontally - oriented pole axis 114 ( fig1 ). a patient receiving space 116 is defined between the poles 112 . flux generating means 118 encircling portions of the frame 100 are provided . in this particular embodiment , since the flux return yoke 100 is below the floor 164 , there are two possible open directions of patient entry as indicated by arrows 200 . this dual entry configuration facilitates sequential scanning of patients either in a one way direction or a two way direction . in the one way direction setup , a patient may be moved into the patient receiving space 16 while at least a second patient is prepared just outside the magnet 109 on the same side where the first patient entered the magnet . after the first patient is scanned , he or she is moved forward and out of the patient receiving space 16 to the opposite side of the magnet . next , the second patient is moved in allowing for a continuous stream of patients with minimum downtime for the mri scanner . in the alternative two way setup , one patient may be moved into the patient positioning space 16 from left to right , for example ( fig1 ). the second patient may be positioned outside of the magnet 109 to the right . when the first patient &# 39 ; s scan is complete , he or she may be moved out to the left while the second patient is moved from the right to left into the patient receiving space 16 . this configuration also facilitates mri - assisted surgery and other procedures requiring medical personnel to be within the magnet &# 39 ; s poles 120 . as these and other variations and combinations of the features discussed above can be utilized , the foregoing description of the preferred embodiments should be taken by way of illustration rather than by limitation of the invention set forth in the claims .

US-78946001-A

a personal immersion tank and aquarium combination , comprising a first tank having vertical walls and a bottom for allowing water to be contained therein , wherein one of the walls at least is translucent for viewing therefrom , a second tank disposed adjacent the first tank and constructed to contained sea life and water for supporting such sea life , the second tank having vertical sides and a bottom with a portion of the vertical sides adjacent to and in contact with the at least one translucent wall of the first tank being also translucent such that a viewer that is positioned outside of both the first tank and the second tank can see through the walls of the second tank to the first tank and a person immersed in the first tank can see through the walls of the second tank through the at least one translucent wall in the first tank .

referring now to the drawings , wherein like reference numbers are used herein to designate like elements throughout , the various views and embodiments of a swimming pool design are illustrated and described , and other possible embodiments are described . the figures are not necessarily drawn to scale , and in some instances the drawings have been exaggerated and / or simplified in places for illustrative purposes only . one of ordinary skill in the art will appreciate the many possible applications and variations based on the following examples of possible embodiments . swimming pools and aquariums commonly have relatively standard designs . while combinations of swimming pools and aquariums exist , the aquarium is typically placed within or otherwise supported by the swimming pool to allow people in the swimming pool to see the aquarium . however , this makes it difficult for those outside of the swimming pool to see the aquarium , as the water level of the aquarium must rise above the water level of the swimming pool in order for the contents of the aquarium to be easily viewable from outside the swimming pool . this requirement diminishes the design options and may be less visually pleasing . furthermore , as such swimming pools are typically in - ground , neither the swimmers nor the contents of the aquarium are easily visible from outside the swimming pool . accordingly , a design that addresses these issues may be desirable for facilities that want to maximize the visual impact of the swimming pool / aquarium combination . referring to fig1 a , one embodiment of a structure 100 is illustrated with one portion that is a swimming pool 102 and another portion that is an aquarium 104 . in the present example , the swimming pool 102 is substantially rectangular in shape and includes walls 106 , 108 , 110 , and 112 , and a floor 114 . the swimming pool 102 and aquarium 104 share the wall 106 , and the aquarium 104 further includes walls 116 , 118 , and 120 and a floor 122 , and is also substantially rectangular in shape . in some embodiments , the aquarium 104 may also include a partial or complete top ( not shown ) that partially or completely shields the aquarium from the environment , may be transparent , and / or may be strong enough to be used as a walkway . it is understood that the aquarium 104 ( and any aquarium discussed herein ) may actually be two or more distinct aquariums , rather than the single aquarium shown in the present embodiment . at least the common wall 106 and the wall 118 are made of a material ( e . g ., glass or plastic ) that is relatively transparent , thereby allowing a user to see through the wall 118 , through the wall 106 , and into the swimming pool 102 . this requires that the wall 118 is viewable , meaning that the wall 118 is either above ground ( e . g ., some or all of the swimming pool 102 and aquarium 104 are above ground ) or that the wall 118 is set into another wall or area where it is viewable ( e . g ., in a below ground level room such as a restaurant , lounge , or other area ). in some embodiments , the swimming pool 102 and aquarium 104 may be completely or partially above ground . in such embodiments , most or all of the walls 106 , 108 , 110 , 112 , 116 , 118 , and / or 120 , as well as the floors 114 and / or 122 may be transparent . it is noted that although the swimming pool 102 is larger than the aquarium 104 in the present embodiment , in other embodiments the aquarium may be larger than the swimming pool or the aquarium and the swimming pool may be the same size . with additional reference to fig1 b , a top view of the structure 100 of fig1 a is provided . in the present example , the swimming pool 102 has a length l1 defined by wall 110 and a length l3 defined by the common wall 106 . the aquarium 104 has a length l2 defined by wall 118 and length l3 defined by the common wall 106 . as the swimming pool 102 and aquarium 104 are rectangles of the same length , the lengths l1 , l2 , and l3 are equal . the width of the swimming pool 102 is defined by widths w1 and w2 ( which are equal in this example ) provided by walls 108 and 112 , respectively . the width of the aquarium 104 is defined by widths w3 and w4 ( which are equal in this example ) provided by walls 116 and 120 , respectively . with additional reference to fig1 c - 1e , additional views of the structure 100 of fig1 a are provided , including a side view of the wall 110 ( fig1 c ), a side view of the wall 118 ( fig1 d ), and an end view of walls 108 and 116 ( fig1 e ). heights h1 , h2 , h3 , and h4 are equal in the present example . it is understood that some or all of the lengths l1 - l3 , widths w1 - w4 , and / or heights h1 - h4 may be different from one another . for example , the bottom 114 of the swimming pool 102 may slope downwards from a shallower end at the wall 108 to a deeper end at the wall 112 . in this case , the height h1 of wall 112 would be greater than the height h2 of wall 108 . the bottom 122 of the aquarium 104 may mimic the slope of the bottom 114 or not , depending on the visual aspect desired for the structure 100 . referring to fig2 , one embodiment of the wall 106 is illustrated . in the present example , the wall 106 defines widths w1 - w4 . the widths w1 - w4 may be equal or may be different depending on the particular design of the structure 100 . the widths w1 - w4 may typically be selected to provide optimal visibility while ensuring that the swimming pool 102 and aquarium 104 remain separated . for example , the widths w1 - w4 may be selected to both contain the water present in the swimming pool 102 and aquarium 104 , as well as to withstand impacts from swimmers . in some embodiments , the widths w1 - w4 may be sufficient to allow one of the swimming pool 102 and aquarium 104 to be empty of water while the other is full of water , thereby allowing maintenance to be performed on the one without impacting the other . in other embodiments , the widths w1 - w4 may not be sufficient for separate maintenance and a certain level of water may need to be maintained in both the swimming pool 102 and the aquarium 104 to provide support to the wall 106 . although the wall 106 is shown as a single transparent wall in fig1 a and fig2 , it is understood that some of the wall may be translucent or opaque . for example , only the upper half may be transparent , while the lower half may be made of a non - transparent material . accordingly , by varying the design of the wall 106 , different visual designs may be implemented . in addition , while shown as a single wall , it is understood that the wall 106 may be multiple layers in some embodiments , with or without separation ( e . g ., air or water ) between the individual layers forming the wall 106 . referring to fig3 , one embodiment of the structure 100 of fig1 a is illustrated with swimming pool equipment 200 and aquarium equipment 202 . the swimming pool equipment 200 may include filter ( s ), pump ( s ), heater ( s ), cleaner ( s ), light ( s ), and / or other equipment used in the operation and maintenance of a swimming pool . the aquarium equipment 202 may include filter ( s ), pump ( s ), heater ( s ), cleaner ( s ), light ( s ), and / or other equipment used in the operation and maintenance of an aquarium . the equipment 200 and 202 may include both equipment located with the swimming pool 102 and aquarium 104 , as well as equipment positioned outside of the swimming pool 102 and aquarium 104 . referring to fig4 , one embodiment of a structure 400 is illustrated with a swimming pool 402 and an aquarium 404 . the structure 400 is similar to the structure 100 of fig1 a and like parts are numbered as in fig1 a . however , the aquarium 404 of the structure 400 is positioned along the wall 108 of the swimming pool 402 as well as along wall 106 as shown in fig1 a . accordingly , the aquarium 402 includes additional walls 406 and 408 . at least the walls 106 and 118 are transparent as described with respect to fig1 a , and the walls 108 and 406 are also transparent in this embodiment . referring to fig5 , one embodiment of a structure 500 is illustrated with a swimming pool 502 and an aquarium 504 . the structure 500 is similar to the structure 400 of fig4 and like parts are numbered as in fig4 . however , the aquarium 504 of the structure 500 is positioned along the wall 110 of the swimming pool 502 as well as along walls 106 and 108 as illustrated in fig4 . accordingly , the aquarium 502 includes additional walls 506 and 508 . at least the walls 106 , 108 , 118 , and 402 are transparent as described with respect to fig4 , and the walls 110 and 506 are also transparent in this embodiment . referring to fig6 a and 6b , one embodiment of a structure 600 is illustrated in perspective and top views , respectively , with a swimming pool 602 and an aquarium 604 . the structure 600 is similar to the structure 100 of fig1 a but is different in shape . accordingly , the swimming pool 602 includes a curved outer wall 606 ( that may or may not be transparent ) and a transparent inner wall 610 that is shared with aquarium 604 . the aquarium 604 also has an outer wall 608 that is transparent . referring to fig7 a and 7b , one embodiment of a structure 700 is illustrated in perspective and top views , respectively , with a swimming pool 702 and an aquarium 704 . the structure 700 is similar to the structure 600 of fig6 a and 6b and like parts are numbered as in fig6 a and 6b . however , the structure 700 includes a second aquarium 702 positioned opposite the aquarium 604 . the aquarium 702 shares a common wall 704 with swimming pool 602 and also has a curved outer wall 706 . the walls 608 and 610 are transparent as described with respect to fig6 a and 6b , and the walls 704 and 706 are also transparent in this embodiment . in some embodiments , the portions of the wall 606 that are not adjacent to an aquarium may not be transparent . referring to the following embodiments generally , various examples of structures are illustrated . although the swimming pool 102 and aquarium 104 are illustrated in preceding embodiments as being substantially rectangular in shape , it is understood that the structure 100 may be configured in many different ways . for example , the swimming pool may include one or more curves or other non - linear shapes and the aquarium may follow the lines of the swimming pool . in other embodiments , the aquarium may not follow the lines of the swimming pool , but may have a different shape as defined by the aquarium walls not shared with the swimming pool . accordingly , various alternative embodiments are illustrated in the following figures , although it is understood that many other configurations may be used and the provided embodiments are for purposes of example only and are not intended to be limiting . referring to fig8 a - 8c , a top view of one embodiment of a structure 800 is illustrated with a swimming pool 802 and two aquariums 804 and 806 . an alternative embodiment may reverse this arrangement , with a single aquarium 802 and two adjacent swimming pools 804 and 806 . fig8 b illustrates one possible cross - sectional view , with the aquariums 804 and 806 maintained separately . fig8 c illustrates another possible cross - sectional view , with the aquariums 804 and 806 connected underneath the swimming pool 802 by a fluid passage 808 , which may serve as the floor of the swimming pool 802 in some embodiments . referring to fig9 a and 9b , a top view of one embodiment of a structure 900 is illustrated with a swimming pool 902 and an aquarium 904 . fig9 b illustrates one possible cross - sectional view , with the aquarium 904 serving as some or all of the ceiling of an area underneath the aquarium 904 , such as a room . walls , columns , or other supports ( not shown ) in the lower area may be used to support the aquarium 904 in some embodiments . referring to fig1 a and 10b , a top view of one embodiment of a structure 1000 is illustrated with a swimming pool 1002 and an aquarium 1004 . the structure 1000 is anchored to a wall 1004 . fig1 b illustrates one possible side view , with the aquarium 1004 overhanging an empty space . referring to fig1 a , a top view of one embodiment of a structure 1100 is illustrated with a swimming pool 1102 and an aquarium 1104 . referring to fig1 b , a top view of one embodiment of a structure 1110 is illustrated with a swimming pool 1112 and an aquarium 1114 . one or more walkways 1116 may be positioned to provide access to the swimming pool 1112 . the walkway 1116 may be over the aquarium 1114 so that the aquarium 1114 runs underneath the walkway 1116 , or may run be through all or a portion of the aquarium 1114 . referring specifically to fig1 c , a top view of one embodiment of a structure 1120 is illustrated with a swimming pool 1122 and an aquarium 1124 . as illustrated , the aquarium 1124 is larger on one side of the swimming pool 1122 than on the other two sides . referring specifically to fig1 d , a top view of one embodiment of a structure 1130 is illustrated with a swimming pool 1132 and an aquarium 1134 . referring specifically to fig1 e , a top view of one embodiment of a structure 1140 is illustrated with a swimming pool 1142 and two aquariums 1144 and 1146 . although the aquariums described herein are generally illustrated as positioned on the ground or in the ground , it is understood that they may be positioned in other ways . for example , an aquarium may be suspended ( e . g ., by cables ), placed on a stand or other structure , wrapped around a column , or otherwise supported . accordingly , the disclosure herein is directed to the placement of an aquarium relative to a swimming pool and need not be limited to particular support structures . although the preferred embodiment has been described in detail , it should be understood that various changes , substitutions and alterations can be made therein without departing from the spirit and scope of the invention .

US-201414286987-A

the invention relates to a computerized handheld substantially pocket size device for satiety registering and satiety response and a method therefore . it is utilized in aiding a person , in a controlled manner , to appreciate when to eat , comprising in -/ output means , electronic memory , a display screen and a modified borg type scale for rating of satiety .

the obese are typically motivated to eat , even though they are not hungry , because they fear that they may soon be in a situation where they will not be able to obtain food . they also report being hungry all of the time when they try to lose weight . these two factors doom most attempts at treatment . the present invention provides a device ( working name satietymeter ) that aids people to learn , remember their satiety , or practice how to feel fullness or satiety , so that they can live a comfortable life or suppress or cure a prevailing eating disorder . in doing so it sets forth a preferably pocket sized computerized personal digital assistant ( pda ) or the like , fig1 . the pda is a conventional device 10 having a pointer means 12 for manipulation of functions , in -/ output and the like shown on a display screen 14 , and possibly equipped with buttons 16 for in -/ output or a keypad . to provide the device for remembering or teaching satiety to persons that need such a feature , the device 10 comprises specific software residing in the device 10 electronic memory space . this software or computer program creates a scale 18 on the display 14 . the scale 18 is a type of modified borg scale 18 preferably divided in even steps of for instance 0 . 0 to 100 incremented in steps of 0 . 1 ( 1 / 10 ), or other suitable scale steps for performing the specific task . to guide a person who uses the device 10 , the scale 18 is highlighted , at specific locations of it , with prompting text for input of felt satiety by a person . the prompting text , in one embodiment suggests , for example , “ rate your fullness ”, and levels in the scale from 0 . 0 to 100 are identifying ratings of fullness such as for instance not at all , extremely weak , very weak , weak , moderate , strong , very strong , extremely strong , and maximal fullness , see fig1 . it is appreciated that other wordings may be used , but the underlying principle prevails . also , in a simple embodiment , the scale 18 could be provided with its numerical rating values , for example , 0 , 0 ; 0 , 1 ; 0 , 2 . . . 99 , 8 ; 99 , 9 ; 100 or the like . the scale 18 may also have other ranges and division of scale steps including narrower steps for specific ratings as for instance in the moderate region or any other suitable region as obvious for a person skilled in the art . although the scale 18 is depicted as a pile in fig1 , it could as well be presented as any other suitable graphic such as a circular pie diagram , serpentine , a person graphic , animals , plants , houses and other . there are unlimited varieties of graphics that can be used to represent the scale 18 , and it should be kept in mind that they can provide extra joy to children using the device . it should be noted that the concept of rating satiety or fullness could in one embodiment of the present invention as well be changed to a rating of feeling hunger . while conducting clinical tests , further elucidated below , on obese children it turned out that they quickly embraced the device and enjoyed using it . this notion is important as there are severe health problems related to obesity in children as it is not unusual that a child , not even ten years old , can weigh more than 100 kg . the device 10 in one embodiment is equipped with a card receiver and slot ( not shown ), whereby recordings of satiety for a later evaluation can be stored on the card . it is also possible to store recorded information in a stationary device 10 memory . a possible session for a person to register a satiety rating after a meal could have duration of two hours , whereby the person would be asked , for example , once every 15 minutes , seven rating attempts , to register satiety . the device 10 alerts the person every 15 minutes through a sound or preferably by vibrations that it is time to register satiety . clinical tests as mentioned showed that persons using the device 10 found it embarrassing that others had knowledge of what was going on due to sounds that alerted the person , and thus rather preferred to register ratings in privacy which can be achieved when accomplishing alerting through vibrations . on the display screen 14 the scale 18 pops up when a registration is alerted and the user points with the pointing means 12 on the scale 18 displayed on the display screen 14 to register the felt satiety at the actual time after a meal . fig2 illustrates a diagram measuring satiety during a meal to the left of the broken line boarder , the boarder divides a 100 percent food intake from a measurement of satiety after food intake in the same diagram . the diagram in fig2 makes it clear that neither food intake related to satiety nor the duration of satiety after food intake is a linear function . the diagram can be used to show or convince a person that registers strange ratings ( in relation to normal ) that it is impossible for instance to rate satiety to very weak 15 minutes after having rated satiety to maximal . of course scientists are helped to draw conclusions of registered ratings in relation to the type of eating disorder and the number of people that register out of diagrams like that shown in fig2 . there is no absolute knowledge or formula of what guides the notion of satiety more than that it is biologically conditioned . hence , registered data from a vast population of users of the device would answer many questions . in fig3 one embodiment of a floating color scale is depicted , the person rating her / his satiety is provided a recommendation of when to take the next meal . for example when a person starts to rate , the first satiety rating would probably be high , close to maximal . this could be represented by a less bright green color ( a in fig3 ) to indicate that it is not “ green ” to take your next meal yet . as time passes and the ratings of satiety become lower the green color gets brighter ( b to a in fig3 ) in a floating manner , which indicates that it is more and more acceptable to eat . this floating color could in another embodiment of the invention be combined with at least two colors , for example red and green . the embodiment could begin with a very bright red color for high ratings of satiety meaning “ do not eat ”. as satiety declines the red color becomes less and less bright to a turning point , for example , at the rating moderate satiety in the scale , where the color switches to a less bright green color meaning “ it is not entirely forbidden to eat ”, whereby the green color gets greener and greener saying “ please do eat ”. in a further embodiment multiple colors could be used to illustrate the floating color scale such as for instance red , yellow , and green similar to the color combination of traffic lights , which are familiar to most persons . additionally , the floating colors could be combined with flashing icons and / or sound or the like on the screen 14 telling a user when to eat . in a very simple embodiment no color scale is provided but only a sound and / or flashing icon to tell a user to eat . it is appreciated that the scale 18 could be reversed in its appearance on the screen 14 . clinical studies mentioned have shown that an obese person can lose approximately 0 . 2 kg a week by using the device of the present invention to guide when to eat . while the mandometer ® trademark of the device disclosed in u . s . pat . no . 5 , 817 , 006 to bergh et al , is effective in giving feedback regarding satiety during meals , the satietymeter or device 10 of the present invention allows feedback to be given regarding satiety levels between meals . since patients often say they eat because they are bored or because they have nothing else to do , this kind of information makes it possible for patients to stop eating between meals . a patient carries a satietymeter of the present invention in her / his pocket and the unit signals every 15 minutes between meals to elicit an estimate the level of satiety . if the patient rates her / his level of satiety as weak , or very weak , she / he would be expected to eat . however , if the satiety estimate is average , or above average , the patient is expected to refrain from eating . the satietymeter thereby makes the patient consider if she / he actually is hungry before eating . patients learn to identify those times between meals when they eat for reasons other than hunger . as a patient reduces her / his body weight , the stomach adapts and the feeling of fullness is experienced earlier during the meal . thus , the perception of hunger and satiety can be modified with mandometer ® and the satietymeter of the present invention to establish new patterns of behavior . a change in environment is often necessary to eliminate environmental cues that maintain old habits with regard to food intake and activity and it is often easier to eliminate old behaviors in a new environment than in the one in which it was developed . starting the program while staying with a relative or friend over a weekend may help these new behaviors to be established . a pilot trial with nine morbidly obese children ( bmi at least 35 kg / m 2 ) is ongoing at the department of pediatric endocrinology , bristol royal hospital for children . university of bristol , england . the children are 12 - 18 years old and they have been treated unsuccessfully with the standard of care for at least one year . all but one have responded to the mandometer ® treatment , with a total weight loss ranging from 2 - 9 kg in up to three months of treatment . they feel “ they are not on a diet ” and have “ stopped snacking ” between meals . “ the satietymeter makes me think that i don &# 39 ; t have to eat ” is another comment repeatedly heard . their eating rate has decreased and the feeling of fullness starts earlier in the meal than it did before treatment . there is also an improvement of their self - esteem , they have started to socialize with peers , they watch less tv ( from 6 to 2 hr / day ), and they have increased their physical activity . fig4 shows in a diagram that the satiety ratings of healthy women decline after a meal . by contrast , anorexic women rate their satiety as much higher after a meal than healthy women despite eating less food and they also continue to rate their satiety as higher during a two hour period after the meal . fig4 depicts satiation in 24 control women ( 19 . 8 , range : 18 - 21 , years old ) and 5 anorexic women ( 16 , range : 14 - 17 , years old ) at different times after intake of 282 ( range : 154 - 452 ) and 111 ( range : 54 - 154 ) g food in 8 . 6 ( range : 5 . 3 - 12 ) and 16 . 6 ( range : 14 - 21 ) min , respectively . values are medians . measures of variability are omitted to facilitate visual inspection . the verbal expressions on the satiety curve are in accordance with the present invention : none at all , very weak , etc corresponding to numerical values : 0 - 100 . the scientific test data of fig4 has not yet been made available to the public . the present invention has been described through examples and embodiments not intended to limit the scope of the invention . hence , the invention is determined through its attached set of claims , which in addition suggests further embodiments to a person skilled in the art .

US-62596603-A

a method is provided for decontaminating biological pathogens residing in an enclosure of an electronic device . the method includes : identifying materials used to encase the enclosure of the electronic device ; tailoring x - ray radiation to penetrate the materials encasing the enclosure ; and directing x - ray radiation having a diffused radiation angle towards the electronic device .

fig1 illustrates a rapid and non - destructive decontamination technique for electronic equipment . when exposed to a contaminated environment , biological pathogens may penetrate the exterior surface of an exposed piece of electronic equipment . in this case , x - ray radiation may be used to sterilize biological pathogens found in interior compartments of the equipment . it is envisioned that x - ray radiation may be used to sterilize other type of decontaminates which may reside within a piece of electronic equipment . first , the materials which comprise those parts of the contaminated equipment between its exterior surface and the deepest internal contamination site , and their thicknesses and densities , must be determined as shown at 12 . x - ray radiation can then be tailored at 14 to penetrate those materials of the exterior surface of the equipment . x - ray radiation of different photon energies penetrates different materials to different depths . the x - ray transmission , t i , of material i used to construct a piece of equipment is given by where σ i is the absorption material &# 39 ; s atomic cross section , n i is the number density ( atoms per cubic centimeter ), and l i is the path length that the x - rays follow through the absorption material . for a combination of several layers of different materials , the total transmission is each material &# 39 ; s atomic cross section is a function of the photon energy . above the k - shell binding energy , the cross section varies as the inverse square of the photon energy . this strong relationship results in a wide range of transmission t versus energy . an energy level for the x - ray radiation is preferably chosen at which t = e − 1 . the ideal x - ray photon energy penetrates exactly through the material containing a contaminant , but no more . use of high energy radiation is wasteful because a preponderance of the incident energy passes through the target without significant energy deposition . on the other hand , very soft x - rays are absorbed by short depths of a material and thus do not penetrate to the location of embedded contaminants . thus , it is preferable to select the lowest photon energy level needed to pass through the exterior surface of the electronic equipment . for different types of electronic devices , there will be a relatively narrow range of energies which is best suited , matched to the devices mean absorption depth . fig2 illustrates an x - ray photon transmission curve for typical plastics ( i . e ., 2 . 5 mm of polypropylene plastic ). at 5 kev , only a few percent of the radiation penetrates the plastic such that bacteria on the other side of the plastic may survive . at 12 kev , most radiation passes through the plastic without interacting with the bacteria . however , at 8 kev , the radiation effectively penetrates the plastic to kill any embedded bacteria . therefore , x - ray radiation having a photon energy of 8 kev is preferable for electronic equipment having a plastic exterior surface . for comparison , it has been determined that radiation having 22 kev effectively penetrates one millimeter of aluminum . it is noteworthy that these energy levels are far above the 1 . 8 kev at which silicon absorbs and thus should not affect the semiconductor components which comprise the equipment . however , the energy levels are low enough that chip packaging will provide some shielding . since most electronic devices have varied constituents , it may be more advantageous to use a source spectrum with several sharp peaks . for example , a source may have two peaks in the spectrum — one that penetrates plastic and a second one that penetrates aluminum . this may be achieved with an anode made of an alloy , such as copper - silver or copper - cadmium , or alternatively a patterned plating of higher z metal on a copper anode . broad spectrum irradiation like bremsstrahlung , while always accompanying line radiation to some extent , is inefficient for decomtanmination because the substantial low - energy fraction will not penetrate the target while the high energy tail will pass through and be lost . compton scattering is mostly negligible at these low energies . in silicon at 8 kev , the photoelectric cross section is almost three orders of magnitude higher than compton . at 22 kev in carbon , the two cross sections are comparable and will be discussed in relation to the pathogen kill mechanism below . when the biological pathogen residing in the equipment is known , the x - ray radiation may be further tailored to sterilize or kill the hazard . for instance , the dose of radiation ( i . e ., the duration of radiation ) applied to the equipment is also determined . the practicality of this concept was demonstrated with a feasibility experiment . samples of 10 6 spores of bacillus subtilis , which is a non - hazardous surrogate for bacillus anthracis , were first placed in a test environment and exposed to a dose of x - ray radiation from a copper anode source having photon energies primarily around 8 kev . irradiated and control samples were then individually incubated in soy broth at 35 ° c . for a week . samples with one or more viable spores produce a cloudy infusion , while a completely sterilized sample remains clear . at delivered doses of over 1 . 5 j / cm 2 , all samples were completely sterilized . the highest dose delivered to a sample that remained incompletely sterilized was 0 . 117 j / cm 2 . hence the 8 kev x - ray kill dose for 10 6 spores of our surrogate fell somewhere between those two values . fig3 illustrates the irradiation time required for a complete kill of 10 6 spores as a function of input electrical power for the upper and lower kill dose bounds . it is well established that killing spores is the most challenging sterilization problem . the radiation dose sufficient to kill bacterial spores is much higher than that required to kill hydrated active bacteria and other biological pathogens . accordingly , radiation doses for active bacteria and other biological pathogens can be empirically derived in a similar manner . any radiation that is energetic enough to penetrate centimeters of contaminated environment will necessarily have a low inelastic cross section with an individual spore . given that , the lower the photon energy , the more likely an interaction with a spore will occur . in fact , the combination of the x - ray requirements of penetrating the spore &# 39 ; s surrounding and also being absorbed by the spore results in a band pass curve as shown in fig4 . note the peak of the curve is near the low - energy cut off determined by the contaminated environment x - ray transmission function . moreover , the electron produced by a soft x - ray absorption event is ideally suited to deliver a maximum energy transfer to the spore . a bacterial spore ( properly referred to as “ endospore ”) is a dormant form that certain bacteria develop when confronted with difficult environmental conditions . it is characterized by a significant water loss ( down to 20 % or less ), concentration of minerals ( particularly calcium ), formation of a multiple membrane outer coat and effectively ceasing metabolism . when a soft x - ray is absorbed in an endospore , a fast - moving primary photoelectron and a slow recoiling ion are produced . the photoelectron traverses the body of the endospore causing secondary ionizations and producing secondary electrons that travel along their paths . the result is a ballistic trajectory of multiple charge displacements . this damage trail can be lethal to the endospore if it significantly disrupts certain structures such as membranes or critical molecules like dna . reactive chemistry can also take place along the ionization trajectory because of all the ions and free radicals produced . for an 8 kev primary photoelectron , the mean free path in protein is very close to 1 μm , or is almost exactly matched to the size of the endospore . at higher energies , the primary photoelectron will exit the endospore long before depositing its full energy . for instance , at 20 kev , the mean path is around 9 μm . electrons produced by compton scattering have the same problem , as compton is a higher energy process . design of the x - ray source for decontamination applications is qualitatively different than for conventional x - ray tubes used for imaging . importantly , the x - ray emitting area needs to be large so that sharp shadows in the illuminated volume are avoided . if sharp , high contrast shadows occur , microscopic pathogens could escape from the irradiation and circumvent the desired sterilization . since x - rays are emitted from the outermost few microns of anode material which receives electron bombardment , the electron beam must be diverged and spread evenly to impinge over the full surface of the anode to achieve the largest effective source size . to this end , the electric field guiding the electrons must be crafted to diverge from the cathode and intersect the anode uniformly , to the greatest extent possible . this technique of manipulating the electric field distribution in the x - ray source is referred to herein as “ field sculpting ”. traditional x - ray sources used for imaging applications are designed as point - source emitters as shown in fig5 . briefly , the x - ray source 30 is comprised of a cathode 31 and an anode 32 housed in an electrically conducting , grounded vacuum enclosure 33 . the cathode 31 is electrically coupled via a load resistor 35 to a power supply 36 . in operation , the cathode emits electrons when energized by the power supply 36 . emitted electrons ( paths indicated by dotted lines 37 ) follow the electric fields and are accelerated towards the anode 32 which in turn emits x - ray radiation 38 ( indicated by dashed lines ) when the electrons impinge upon its surface . the cathode acquires a voltage ( called the self - bias voltage ) equal to the product of the load resistance and the emitted electron current . the combination of the cathode &# 39 ; s acquired negative voltage , the enclosure ground , and the anode &# 39 ; s positive high voltage forms a three - element electron lens , which focuses the electron current density to a small point . all x - ray radiation is generated at that point . although desirable in imaging applications , this source configuration produces sharp shadows of absorbing materials 39 ( which in application would be objects in the contaminated environment such as semiconductor devices , electric leads or wires , for example ) as indicated by the plot of intensity versus position behind the absorber . this may obscure the biological hazards and dramatically reduce decontamination efficacy . to make a diffuse x - ray lamp , it is necessary for a large area of the anode surface to emit x - rays . this requires the electron current to be spread wide , avoiding focusing effects . a modified x - ray source design is shown in fig6 . three major modifications have been made to the classical design to accomplish this electron spreading . first , the cathode 41 is electrically tied to ground to avoid any self - bias voltage ; the load resistor has been removed . second , the surface figure of the anode 42 has been curved into a concave shape . third , a supplementary electrode called the field sculpting electrode 43 is placed surrounding the electron current in close vicinity to the cathode and is biased by a variable voltage 44 . although any one of these changes produces a partial result , the combination of these three changes causes the electric field lines to spread out , drawing the electron current 45 to impact uniformly across the anode surface . in turn , this results in an illumination of the absorber 46 which is diffuse , as indicated by the x - ray trajectories 47 . the term “ diffused radiation angle ” refers to the source possessing the characteristic of a large radiating surface area as viewed by the absorbing material in the contaminated environment , resulting in lowered shadow contrast to avoid having local unirradiated regions . the resulting x - ray intensity pattern behind the absorber does not fall to zero , meaning even if pathogens were to reside behind the absorber they would still be irradiated . the diffused radiation angle may be quantified by a measure analogous to a focal ratio or f - number of a camera . for example , the diffused radiation angle may be measured by an “ f - number ” defined as the distance from the source to the object being irradiated divided by the size of the x - ray spot . for most conventional x - ray sources , the source size is around 100 microns or smaller , such that its “ f - number ” is around 10 , 000 . the diffused radiation angle employed by this disclosure gives an “ f - number ” less than 10 with a final design goal of less than four . additionally , this x - ray source may be configured to irradiate over a very wide angle by positioning the output window as close as possible to the anode . x - rays are generated in the first few micrometers of the anode surface that is bombarded with electron current . any location in the irradiated zone in a clear line of sight to the active anode surface will receive x - rays . the design and location of the output window can be configured to transmit close to a full 2π steradians of irradiated solid angle . furthermore , the radiation should thoroughly penetrate the materials covering , surrounding or otherwise obstructing the biological hazard . the x - ray radiation should not pass through the contaminated materials having failed to interact with the biological hazard . high energy x - ray photons will penetrate denser materials , but the resultant scattering cross - section of the photon is low . therefore , a larger flux of x - ray photons is required , leading to longer exposure times to achieve a sufficient kill dose . this is the reason it is advantageous to choose the x - ray photon energy consistent with the materials needing to be decontaminated . the photon energies produced by an x - ray source can be scaled through the judicious choice of the anode materials . this is understood through moseley &# 39 ; s empirical formula for k - alpha x - rays . the formula shows the x - ray photon energy is dependent on the square of the atomic number of an element where e k is the x - ray photon energy and z is the atomic number of the anode material . for instance , an x - ray source having a molybdenum ( z = 42 ) anode will generate radiation having a photon energy of 18 kev . in comparison , a silver ( z = 47 ) anode can generate radiation having a photon energy of 22 kev . it is envisioned that x - ray sources will be fabricated with different anode materials to ensure penetration through various material compositions providing decontamination radiation inside the electronic device . it is also understood that an x - ray source may employ different types of cathodes , including but not limited to thermionic emitters , such as tungsten - thorium alloy , tantalum , and others , as well as cold cathodes which could be metallic wires or exotic materials like carbon nanotubes . fig7 illustrates an exemplary portable , cart - like decontamination system which may be used to deploy this technology . the decontamination system is comprised of a radiation chamber and one or more x - ray heads arranged to radiate the chamber . each of the x - ray heads are configured to generate x - ray radiation having a diffused radiation angle in the manner described above . the x - ray head will be made more compact by the use of ultra - high dielectric strength insulators , and weight will be reduced . the vacuum seal will be made permanent . the beryllium window will be shuttered for safety , and interlocks will be installed to prevent operation without radiation shielding . with reference to fig8 , the decontamination system is preferably equipped with multiple x - ray heads . in one exemplary embodiment , different x - ray heads are oriented at different angles within the chamber . in this way , different x - ray heads may be selected to generate x - ray radiation depending upon the object being decontaminated . for example , each of the x - ray heads may employ a copper anode suitable for penetrating plastic materials , but only one of the exterior surfaces of the object is made of plastic . in this example , the x - ray head oriented towards the plastic exterior surface is used to penetrate the object . in another exemplary embodiment , different x - ray heads may be configured to generate x - ray radiation at different photon energy levels . for instance , one x - ray head may employ a copper anode while another x - ray head employs a silver anode . thus , different x - ray heads may be used depending on upon the material of the object to be decontaminated . likewise , different x - ray heads may be used to penetrate different enclosures of the same object , where the different enclosures may be encased by different materials . x - ray radiation may also be used for decontaminating the exterior surface of electronic equipment . to do so , the portable decontamination system may be equipped with one set of x - ray heads for producing lower energy x - ray radiation ( e . g ., 8 kev ) and another set of x - ray heads for producing high energy x - ray radiation ( e . g ., 15 - 30 kev ). lower energy x - rays have larger scattering cross - sections and hence interact strongly with biological pathogens found on an exterior surface of any object . on the other hand , higher energy x - rays are needed to penetrate the exterior surface of the object . penetrating x - rays may interact with biological pathogens within an enclosure of an object by producing fluorescence . although the conversion efficiency is low , these photons have scattering cross - sections 900 times larger , thereby achieving effective decontamination within a cavity . in an alternative configuration , the decontamination system may be equipped with ultraviolet radiation sources for effectuating surface decontamination . conventional ultraviolet lamps are readily available in the marketplace . ultraviolet radiation has proven effective for decontaminating and sterilizing biological pathogens . for example , kill doses for uv radiation at 254 nm has been measured . for bacillus anthracis , doses delivered at 45 mj / cm 2 achieved a 99 . 9 % kill rate of the pathogen on the surface . doses are low because every photon in absorbed . however , ultraviolet radiation does not penetrate materials . therefore , x - ray heads are also employed in the manner described above for internal decontamination . the above description is merely exemplary in nature and is not intended to limit the present disclosure , application , or uses .

US-98622807-A

a multi - compartment , wiper - applicator package comprising a container holding a first formulation , a wiper , initially sealed at both ends and a barbed tool . within the sealed wiper is a quantity of secondary ingredients that is to be mixed with the first formulation in the container . the barbed tool is able to pierce the top seal , then dislocate the bottom seal , completely separating the bottom seal from the wiper . thereafter the barbed tool removes the top seal completely , so that , what remains , is a conventional wiper . the barbed tool can be inserted only to a defined depth in the wiper . this prevents the barbed tool from removing the wiper from the container .

a “ multi - compartment , wiper - applicator package ” according to the present invention ( fig3 ) comprises a container ( 1 ) that is capable of holding a first formulation ( m ). in the case of mascara , the container is generally a cylindrical vial having a neck ( 2 ) with a screw threaded finish . the top ( 3 ) of the neck has an orifice that allows access to the interior of the container . a novel wiper ( 10 ) is disposed in the neck ( 2 ) of the container ( 1 ). the wiper is secured in the neck of the container such that it cannot easily or accidentally be removed during normal use . generally , a tight friction fit between the wiper and container neck is sufficient to ensure this . referring to fig4 a and 4 b , a wiper may have one or more raised beads ( 11 ) that ensure sufficient retention of the wiper in the container neck . the friction fit between the wiper and container neck is as air tight as that term is generally understood in the art . a typical wiper may have a flange ( 12 ) that rests on the top ( 3 ) of the container neck , when the wiper is fully seated in the container . the wiper has an upper orifice and a lower orifice , similar to a conventional wiper . prior to first use , as shown in fig4 and 4 b , the upper and lower orifices are sealed by an upper seal ( 13 ) and a lower seal ( 14 ), respectively . the upper seal ( 13 ) closes off the upper orifice of the wiper ( 10 ) and forms an air tight and / or fluid tight seal with the wiper . preferably , the upper seal is friction fit to the wiper to achieve the air tight seal . for example , the upper seal could surround the wiper flange ( 12 ) such that the air tight connection is achieved against the exterior of the wiper . preferably , however ( and as shown in fig4 b ), the upper seal is inserted into the upper orifice of the wiper and a friction fit is achieved between the exterior of the upper seal and the interior of the wiper . this arrangement may create a more sleek , less bulky appearance . the upper seal ( 13 ) may be provided with a flange ( 15 ) that rests against the flange of the wiper ( 10 ) when the upper seal is fully seated on the wiper . however , the contact between the upper seal flange and the wiper flange is not the primary seal . the upper seal flange merely limits the depth to which the upper seal can be inserted into the wiper . the primary air tight seal occurs inside the wiper , down a distance . the upper seal also has a weakened portion ( 16 ) that can be pierced or punctured relatively easily with a sharp object . in fig4 b , the weakened portion is located a distance down , into the upper seal . the weakened portion is relative to the rest of the upper seal , which cannot be pierced or punctured as easily as the weakened portion . while an air tight friction fit exists between the upper seal ( 13 ) and the wiper ( 10 ), this fit should not be so tight that pulling the upper seal would dislodge the wiper from the container ( 1 ). simultaneously , this fit should not be so tight that it is unduly difficult for a consumer to remove the upper seal from the wiper . a person of skill in the art may , by routine experimentation , arrive at the correct air tight fit . after the upper seal is removed , it is imperative that an airtight seal be possible between the flange ( 12 ) of the wiper and the container closure . the lower seal ( 14 ) closes off the lower orifice of the wiper ( 10 ) and forms an air tight and / or fluid tight seal with the wiper . preferably , the lower seal is friction fit to the wiper to achieve the seal . for example , the lower seal could surround a lower portion of the wiper such that the air tight connection is achieved against the exterior of the wiper . preferably , however ( and as shown in fig4 b ), the lower seal is inserted into the lower orifice of the wiper and a friction fit is achieved between the exterior of the upper seal and the interior of the wiper . this arrangement may create a slimmer wiper profile , that can fit into standard container openings . the lower seal ( 14 ) may be provided with a flange ( 17 ) that rests against the base of the wiper ( 10 ) when the lower seal is fully seated on the wiper . the lower seal flange will limit the depth to which the lower seal can be inserted into the wiper . unlike the upper seal , the lower seal does not have a weakened portion that can be pierced or punctured relatively easily with a sharp object . a weakened portion in the lower seal might defeat the operation of the invention . while an air tight friction fit exists between the lower seal ( 14 ) and the wiper ( 10 ), this fit should not be so tight that it is unduly difficult for a consumer to dislodge the lower seal from the wiper . a person of skill in the art may , by routine experimentation , arrive at the correct fit . the container ( 1 ) defines a primary compartment ( 1 a ). the sealed wiper ( 10 ) creates a secondary compartment ( 18 ) which can hold a quantity of secondary ingredients ( i ). there are a number of options for assembling and filling the components . for example , the container ( 1 ) can be filled in a usual manner with a first formulation ( m ). the lower seal ( 14 ) can be affixed to the wiper ( 10 ). the wiper can be filled with a quantity of secondary ingredients ( i ). the upper seal ( 13 ) can be affixed to the wiper . then , the sealed wiper can be affixed into the container orifice . alternatively , the container ( 1 ) can be filled in a usual manner with a first formulation ( m ). the lower seal ( 14 ) can be affixed to the wiper ( 10 ). then , the partly sealed wiper can be affixed into the container orifice . then the wiper can be filled with a quantity of secondary ingredients ( i ) and the upper seal can be affixed to the wiper . once the package is filled and assembled , a closure ( 22 ) for the container is optional . the closure would screw onto the container in the usual manner , except that when fully seated , the closure would bear down directly on the upper seal flange ( 15 ), rather than on the wiper flange ( 12 ). of course , this closure does not have an applicator depending from it , as is commonly done in the art . thus , the applicator must be separately supplied , to be used after the upper ( 13 ) and lower ( 14 ) seals have been dislodged . to dislodge the upper and lower seals , a “ multi - compartment , wiper - applicator package ” according to the present invention includes a seal removal tool . one embodiment of a seal removal tool is the barbed tool ( 19 ) of fig7 a - d . the barbed tool is capable of piercing the weakened portion ( 16 ) of the upper seal ( 13 ), then dislodging the lower seal ( 14 ), and then lifting the upper seal ( 13 ) out of the wiper . when inserted into the wiper , the pointed end of the barbed tool breaks through the weakened portion of the upper seal ( fig7 b ). the pointed end cannot so easily break through any portion of the upper seal , except the weakened portion . inserting the tool further , the tool comes to bear against the lower seal . with sufficient force that a consumer could supply by hand , the lower seal is dislodged and pushed into the primary compartment , completely separated from the wiper ( fig7 c ). at this time , the secondary ingredients fall into the primary compartment . the size and shape of the lower seal are such that it cannot , at a later time , pass through the lower orifice of the wiper . also , the dislodged lower seal in the primary compartment causes no problems when an applicator is inserted . in fact , the dislodged lower seal may serve as a mixing element , helping to mix the first formulation and the secondary ingredients . to prevent the barbed tool from inserting too far into the wiper , a portion ( 20 ) of the barbed tool comes to rest against the flange ( 15 ) of the upper seal . by “ too far into the wiper ”, we mean that the barbed tool should not be able to catch on the underside of the wiper , so as not to dislodge the wiper . once the barbed tool is resting against the flange of the upper seal , raising the barbed tool will cause one or more barbs ( 21 ) to bear against a portion of the upper seal . with sufficient force that a consumer could supply by hand , the upper seal is dislodged and removed completely from the wiper ( fig7 d ). for all intents and purposes the container now functions like a conventional mascara container with wiper . there is no damage to the wiper and no foreign material residue on the wiper . the barbed tool and upper seal can be discarded . a closure with applicator of the type well known in the art can be inserted into the container and used to seal the container , in the usual manner . a feature of the upper and lower seals is that they can be pushed or pulled out of the wiper and completely separated from the wiper . this feature is necessary so that the upper and lower seals , or any portion thereof , cannot interfere with the functioning of the wiper . for this reason , the upper and lower seals must be sufficiently rigid , so that when the lower seal is pushed by the barbed tool , or the upper seal is pulled by the barbed tool , each seal moves as a complete piece , without breaking or tearing . for this reason , thin membrane seals of paper , plastic , foil etc . are generally unlike the upper and lower seals of the present invention . it is also preferable that the functioning of the wiper is not impaired , when the upper seal ( 13 ) and lower seal ( 14 ) are removed . thus , the wiper should not be damaged by removing the seals and no foreign material should be allowed to interfere with the wiper . for example , it is preferable to effect the upper and lower airtight seals without the use of adhesives . adhesive residue on the wiper flange ( 12 ) might interfere with the air tight seal between the wiper flange a container closure . anything less than a complete air tight seal will lead to rapid dryout of the formulation , rendering the product unusable . furthermore , after the lower seal is dislodged , adhesive residue on the lower portion of the wiper might interfere with the functioning of the wiper . also , adhesives residue on the wiper could interfere with the stability of the formulation . thus , the preferred embodiment of the present invention does not form the upper and lower airtight seals in a way that would leave any foreign material on the wiper or that would otherwise interfere with the functioning of the wiper . ideally , a friction fit is used . given the availability of a secondary compartment , there are any number of secondary ingredients that a skilled formulator might want to include in the sealed wiper . such materials include any that can be effectively mixed into the first formulation at the time of first use and for which it is advantageous to delay their mixing until the time of first use . in general these include , but are not limited to colorants , actives , preservatives , desiccants and rheology modifiers . functionally , these might include : curlers , lengtheners , separators , declumpers , volumizers , deflakers , despikers , lash thickeners , desmudgers , etc . one example of an active that might benefit by being kept separate from the first formulation until the time of first use is the enzyme , transglutaminase . transglutaminase has been used in eyelash products to retain the curl the lashes . however , the activity of transglutaminase depends on several factors , including the ph of the formulation in which it is disposed ( 5 to about 9 is recommended and about 6 to about 7 is particularly preferred ), exposure to heat ( should be avoided ), exposure to certain types of surfactants ( anionic surfactants adversely affect the enzyme ) and the length of time that it is exposed to these factors . thus , if the first formulation is not optimum for preserving transglutaminase activity , it would be beneficial to keep the transglutaminase separate from the first formulation until the time of first use . the transglutaminase would be protected from the adverse conditions in the first formulation for the entire shelf time of the product . after first use , the transglutaminase will not be protected , but the amount of lost activity may be acceptable over the expected use life of the product . many such instances might arise , where a benefit would be achieved by keeping one or more secondary ingredients separate from the first formulation until the time of first use . in a “ multi - compartment , wiper - applicator package ” according to the present invention , the bottle and closure - applicator are physically separate before the first use . therefore , the present invention includes a kit comprising a container with wiper as described herein , the container holding a first formulation and the wiper holding one or more secondary ingredients ; and a closure - applicator ( 23 ) ( see fig8 ). optionally , a closure ( 22 ) without integral applicator is also supplied with the kit . the closure without applicator can be screwed onto the container to give a more finished appearance . preferably , however , the container with wiper is sufficiently air tight without the closure . improvements to the inventions so far described can be achieved by adding features already known in the art . for example , a multi - compartment mascara package according to the present invention would be even more useful and create wider formulation possibilities if combined with a vibrating applicator . in fact , the vibrating applicator could be used , among other things , to mix the secondary ingredients into the first formulation . one example of a vibrating applicator is described in us2006 - 0032512 . another improvement is expected by combining “ multi - compartment , wiper - applicator package ” according to the present invention with a heated applicator . the heat may be useful for activating some secondary ingredients , or for lowering the viscosity of the first formulation to the allow the secondary ingredients to mix better . one example of a cosmetic applicators containing heating elements is described in us2007 - 0286665 . thus , if energy can be introduced into the container ( i . e . heat or vibration , etc ), the ability to mix ingredients at the time of first use increases the formulation possibilities many fold .

US-16416108-A

a connecting device for use in attaching together at least two adjacent vertebrae comprises upper and lower plate members adapted to be fixedly secured respectively to adjacent upper and lower vertebrae via fasteners , e . g . screws . the upper and lower plate members are provided with respective male and female guide elements that are slidable engaged together so as to allow a relative translational displacement between the upper and lower plate members in response to a similar relative displacement between the upper and lower vertebrae that alters a spacing therebetween . the male guide element comprises longitudinal guide ways , and the female guide element comprises a channel for slidably receiving the male guide element and a pair of side guides extending inwardly and slidably engaged in the guide ways of said male guide element . the female guide element defines a longitudinal slot , and the male guide element comprises a pin extending perpendicularly to a direction of the aforementioned relative displacement and engaged in the slot . a method includes : removing at least part of a disc from an intervertebral space defined between a pair of adjacent vertebrae that include upper and lower vertebrae , and securing first and second plate members respectively to the upper and lower vertebrae , said first and second plate members being capable of relatively displacing for accommodating a change in a distance between the upper and lower vertebrae ; wherein a bone graft is positioned in the intervertebral space .

as discussed hereinabove , when a cervical disc is anteriorly removed ( e . g . using the smith - robinson surgical technique ) from between two adjacent vertebrae , for instance to liberate roots and / or spinal cord which are compressed by a degenerated disc or to remove a damages disc , it is known to fuse both these vertebrae together ( i . e . osteosynthesis by way of an anterior cervical plate ) to provide stability to the rachis although this results in loss of mobility and damping . this rigidification ( on one or more successive discs ) induces greater stresses to the natural discs located adjacently above and below the removed disc ( s ) thereby causing a premature ageing of these natural discs , and also creates experimental conditions for the formation of discal hernias on the adjacent levels . to overcome at least in part these disadvantages , the present invention proposes a new disc prosthesis or prosthetic implant which , in addition to providing stability by connecting the two adjacent vertebrae , allows for some relative movements therebetween , e . g . flexion and extension , and for damping when subjected to axial loads . more particularly , the disc prosthesis p illustrated in fig1 and 1a comprises upper and lower anchoring plates 10 and 12 , respectively , which are adapted to be secured with screws 14 to anterior faces of adjacent upper and lower vertebrae v and v ′. the prosthesis p also includes a joint 16 connected to , and between , both plates 10 and 12 to link both vertebrae v and v ′ in a stable manner and further providing damping characteristics to the prosthesis p and relative movements between the vertebrae v and v ′. the joint 16 comprises a pair of upper and lower arms 18 and 20 , respectively , which define a v - shaped configuration extending rearwardly from an anterior face of the vertebrae v and v ′ and into the intervertebral space s defined vertically between the vertebrae v and v ′. the upper and lower arms 18 and 20 can pivot such as with a hinge , at posterior ends thereof , i . e . at the apex 22 of the joint 16 . the arms 18 and 20 of the joint 16 are biased , as per arrows 24 in fig1 towards an open or expanded position thereof , for instance by way of a spring 26 ( best shown in fig1 a and 1c ) in the form of a arcuately folded sheet , such that upon a movement of the rachis which brings the two vertebrae v and v ′ closer together , the joint 16 closes against the spring force , the arms 18 and 20 pivoting towards each other about the apex 22 , with the spring 26 being adapted to return the joint 16 to its at rest position once the effort made by the user that moves the rachis is released . more than one spring may be used for maintaining , at rest , the joint 16 in an intermediate position , i . e . in a “ floating ” position such that the joint 16 is capable of opening or closing , with the spring forces always bringing it back to its at rest position . the upper and lower arms 18 and 20 of the joint 16 may be integral with the upper and lower plates 10 and 12 , respectively . the joint 16 substantially ensures three functions of the natural disc : stability by providing continuity between the adjacent vertebrae v and v ′, damping in the axial plane : and flexion - extension movements in the sagittal plane - depending on the material used for making the joint 16 ( biocompatible or not ), the joint 16 may be housed in a sealed chamber . the prosthesis p is , for instance , well adapted for the use on the cervical rachis . in fig1 b to 1 e , the joint 16 is shown in extended and flexed positions thereof the joint 16 can also comprise one or more dynamometers ; a system of one or more fluid - based dampers , i . e . with liquid ( s ) or gas ( es ); a bag to replace the natural disc &# 39 ; s annulus , which is filled with a liquid , or other appropriate substance , having a proper viscosity index to replace the nucleus pulposus ; etc . in fig2 and 3 , there is shown a second embodiment of a disc prosthesis p ′ also in accordance with the present invention and which has a cigar - cutter configuration , being located completely anteriorly of the upper and lower vertebrae v and v such as to provide for translational displacements along an axial plane between the vertebrae v and v ( as opposed to the pivoting movement of the first disc prosthesis p of fig1 and 1a ). the second prosthesis p ( see fig2 a and 3 ) comprises upper and lower anchoring plates 30 and 32 , respectively , which are adapted to be secured with screws 34 to anterior faces of the adjacent upper and lower vertebrae v and v ′. this second prosthesis p ′ may also be used on the various vertebrae of the rachis , including advantageously on the cervical rachis . the prosthesis p ′ also includes a joint 36 connecting both plates 30 and 32 to link both vertebrae v and v ′ in a stable manner and further providing damping characteristics to the prosthesis p ′ and relative movements between the vertebrae v and v ′. the upper plate 30 may be inverted u - shaped and define side guide ways 38 while the lower plate 32 defines an extension 40 that is slidably engaged at its longitudinal sides 42 in the guide ways 38 . a stop member ( not shown ) is provided for preventing the complete withdrawal of the lower plate 32 from the upper plate 30 in the event of hyperextension by the patient . as in a cigar cutter , a spring ( not shown ) is preferably provided between the upper and lower plates 30 and 32 , for instance in the guide ways 38 , such that the prosthesis p is biased towards its extended position . alternatively , the spring effect may be provided in the intervertebral space s defined between the vertebrae v and v ′, i . e . posteriorly of the plates 30 and 32 , such a by a coil spring extending vertically between , and linking , both vertebrae v and v ′, or by a damping unit consisting for example of a bag containing a fluid ( liquid or gaseous ). also , the plates 30 and 32 could include a substantially horizontal posterior intersomatic extension , located in the space s and between which a bias system , e . g . a spring or fluid damper , would be provided . for the cervical rachis , the plates 30 and 32 are concave to respect the natural cervical lordosis of the anterior wall of the cervical spine and to guide harmonious flexion - extension movements . in fig2 b to 2 e , the joint 36 is shown in extended and flexed positions thereof . in fig4 to 6 which show a third embodiment also in accordance with the present invention , a further disc prosthesis p ″ is illustrated and is , in fact , a one - piece tissue jacket 100 defining a posterior biconcave constraining chamber 102 adapted to receive therein a hydrogel 104 that acts as a damper , with anterior frontally extending upper and lower extensions 106 and 108 , respectively , adapted to be anchored to the anterior faces of the facing upper and lower vertebrae v and v ′ with screws 112 that extend through reinforced eyelets 110 . more particularly , the biconcave hydrogel 104 of the joint of disc prosthesis p ″ conforms to or mimics the natural shape of a cervical disc ( 16 , 18 or 20 mm depth × 6 , 8 or 10 mm height ) and is surrounded or coated with the deformable constraining jacket 100 located in an intra - spinal inter - somatic space . the pair of frontal , extra - spinal and pre - somatic , upper and lower extensions 106 and 108 extend respectively from the antero - superor and antero - inferior edges of the jacket 100 . as to the nucleus core 104 of this third disc prosthesis p ″, it is made of a hydrogel , which is non - biodegradable and is chemically reticulated by covalent bonds , and which has visco - elastic properties that are similar to those of the natural nucleus pulposus such as to counterbalance or offset the external hydrostatic pressure which is exerted thereon . the hydrogel has a swelling or inflating capability in an aqueous solution of about 85 to 95 %, at equilibrium ( wg ). the hydrogel can be a terpolyrner formed of : ( a ) a methacrylamide n - substitute , for instance [ n - 2 ( hydroxypropyl inethacrylamide )]( epma ); ( b ) a hydroxy alkyl methacrylate ester , for instance 2 - hydroxyethyl methacrylate ( hema ); and ( c ) a di - or tri - ethylene glycol dimethacrylate ( degdma or tegdma ). while it is manufactured , the hydrogel 104 is dehydrated and inserted in the intervertebral cavity . then , it is manually rehydrated in an aqueous solution by using a needle puncture through the coating jacket 100 until its maximal swelling capability ( wg ). the hydtogel is prepared in such a way that wg corresponds to a pre - selected specific volume of the intervertebral bi - concave chamber 102 in order to obtain the adequate pressure . this hydrogel forming the nucleus core , should as much as possible have the deformation properties and the coherence characteristics of the natural nucleus pulposus in order to respectively have dampening curves compatible with the typical levels of mechanical loads of natural lumbar discs and have resistance to fracturing under applied pressures . the tissue jacket 100 should have an intrinsic resiliency , or memory , that gives it a tendency to keep its bi - concave nucleus - like shape during its displacement in the cavity and so maintain contact with the natural vertebra endplates . it should also have enough compliance such as not to modify motions and dampening properties of the hydrogel - nucleus alternatively , the nucleus bydrogel 102 may be shaped in a series of independent flexible micro - beads ( e . g . spheres containing appropriate fluid for damping effect ). finally , the above three ( 3 ) prostheses p , p ′ and p ″, which are adapted to be installed by an anterior approach on any of the cervical , lumbar , dorsal and thoracic rachis , could also be of a multi - level configuration , that is to cover more than two adjacent vertebrae . the holes defined in the anchoring plates 10 / 12 and 30 / 32 or anchoring extensions 106 / 108 may be vertically elongated ( oblong ) to allow for some adjustment in the positioning of the prosthesis p / p ′/ p ″ and so that the latter may be used with patients of various vertebra configurations and sizes . therefore , the prosthesis of the present invention constitutes a system that attaches two vertebrae together while allowing for relative movements , e . g . pivoting , translational or other , between these vertebrae and while providing some spring force or damping therebetween . fig7 to 10 illustrate a device p , also in accordance with the present invention , which is used to connect two adjacent vertebrae v and v ′. the device d is typically used when a natural disc , or part thereof , is removed from between the two adjacent vertebrae v and v ′. the disc is replaced , for instance , by a bone graft ( not shown in the drawings ) that is positioned in the intervertebral , or intersomatic , space s defined between the two vertebrae v and v ′. the device d is secured to both vertebrae v and v ′ via screws 200 that extend though the device d and into both vertebrae v and v ′ ( see fig8 a and 83 ). as the bone graft takes months to fuse with these two vertebrae v and v ′ and as it reduces in size while doing so ( i . e . the bone graft contracts , e . g . from 1 to 2 nun for a bone graft having an initial height of 8 to 10 mm ), any rigid assembly connecting the two vertebrae will unpart , as mentioned hereinbefore , immense stresses generally to itself , rather than to the vertebrae v and v ′ and the bone graft therefore , in order to overcome this shortcoming , the present device d is not of rigid unitary construction , but is rather translationally extendable for accommodating the slow and gradual relative displacement between the vertebrae v and v ′ that takes place during the hardening of the bone graft thereto . indeed , as the bone graft hardens and fuses to the vertebrae v and v ′, it contracts thereby reducing the height of the intervertebral space s , whereby the vertebrae v and v ′ are drawn closer together . to accommodate this movement of the vertebrae v and v ′ and substantially eliminate the abovementioned stresses , the present device d itself vertically contracts , in other words , the device d follows the relative movement of the vertebrae v and v ′, without stress being induced to the device d , the screws 200 , the vertebrae v and v ′ or the bone graft . to do so , the device d , which is the form of a plate , comprises upper and lower plate members 202 and 204 that are adapted to be secured , via the screws 200 , respectively to the upper and lower vertebrae v and v ′. the upper and lower plate members 202 and 204 are slidable engaged one to the other such as to be able to relatively displace in the direction of the movement of the vertebrae v and v ′. the device d thus allows for translational semi - constrained flexibility . more particularly , the upper plate member 202 includes a base 206 and a head 208 , the base 206 includes a t - shaped male guide element 210 that defines a pair of parallel longitudinal side guide ways 212 . the head 208 defines a pair of lateral openings 214 through which the screws 200 are passed , and a central aperture 216 adapted to temporarily receive , in a set position , an alignment mechanism ( e . g . localizer ) during installation of the screws 200 through the device d and into the vertebrae v and v ′. a pin 218 extends perpendicularly from the base 206 . the lower plate member 204 includes a head 220 and a female guide element 222 . the female guide element 222 , as best seen in fig9 comprises a broad channel 224 that defines a pair of parallel longitudinal side guides 226 . the female guide element 222 and its channel 224 and guides 226 receive in a sliding relationship the male guide element 210 and guide ways 212 , so that the upper and lower plate members 202 and 204 can translationally displace relative to another . the head 220 defines a pair of lateral openings 228 through which the screws 200 are passed , and a central aperture 230 used as aperture 216 of the upper plate member 202 . the female guide element 222 also defines a longitudinal slot 232 through which extends the pin 218 of the base 206 of the upper plate member 202 , so as to further guide the upper and lower plate members 202 and 204 in their longitudinal relative displacements . the device d is curved at its anterior and posterior faces to respect adjacent tissues ( bone posteriorly and oesophagus anteriorly ). to connect more than two consecutive vertebrae , the device can have longitudinal ends that are of half - height so that two or more devices can be arranged in an end - to - end relationship with the longitudinal ends of two adjacent devices overlapping and with the screws being passed through these overlapping ends . the device d can be used for all types of vertebrae , including cervical , dorsal , lumbar and sacral vertebrae . it is noted that , in fig8 a and 88 , the device d is shown in inverted position , wherein the upper and lower plate members 202 and 204 are secured respectively to the lower and upper vertebrae v ′ and v . the device d can assume both orientations . the device d could also be used instead of the sliding plate p ′ in the arrangement of fig2 a to 2 e , i . e . wherein the plate is used in combination with a damping system in lieu of the rigid bone graft of the embodiment of fig7 to 10 .

US-35839803-A

a device for mixing anesthetic vapor with anesthetic gas has a pressure limitation feature achieved in a simple manner . the device has a valve device , with which the evaporator is switched on and off . the valve device is equipped with an overpressure release device .

referring to the drawings in particular , fig1 schematically shows an anesthetic vaporizer 1 , which contains an anesthetic tank 2 for liquid anesthetic 3 , a dispensing valve 4 , an adjustable dispensing gap 5 , a bypass line 6 with a bypass gap 7 , a differential pressure sensor 8 , a heater 9 for the anesthetic and an electronic control unit 10 . a valve device 11 on the top side of the anesthetic vaporizer 1 has a lower part 16 with a gas inlet 13 and with a gas outlet 14 and gas ducts 17 , 18 and an upper part 12 with gas ducts 15 , 19 . the upper part 12 is fastened against the lower part 16 in the form of a rotary or slide valve , so that individual gas ducts 15 , 19 of the upper part 12 are connected to gas ducts 17 , 18 of the lower part 16 in predetermined positions of the upper part 12 . the upper part 12 is pressed onto the lower part 16 by means of a spring 22 . in the switching position shown in fig1 , the gas inlet 13 and the gas outlet 14 are connected to one another directly via the gas ducts 15 , 17 , and the anesthetic gas is sent past the dispensing device 2 , 4 , 5 , 6 , 7 . together with the gas ducts 18 , 19 , the bypass line 6 now forms a closed circular pipe . the gas ducts 15 , 17 , 18 , 19 cross an interface 23 between the upper part 12 and the lower part 16 . if an increased pressure or pressure rise occurs within the bypass line 6 or at the differential pressure sensor 8 connected with the bypass line 6 , such a pressing force is exerted on the upper part 12 via the gas duct 19 that , as is illustrated in fig2 , the upper part 12 lifts off from the lower part 16 and the pressure can drop along arrow 24 . identical components in fig2 are designated by the same reference numbers as in fig1 . since the gas duct 15 is connected to the gas inlet 13 and the gas outlet 14 via the gas ducts 17 , the pressure also drops when an increased pressure or pressure rise is present in the gas duct 15 . fig3 illustrates the anesthetic vaporizer 1 in a second switching position in the switched - on state . the gas inlet 13 is connected with the gas outlet 14 here via the gas ducts 17 , 18 , 20 , 21 and the bypass line 6 . the gas ducts 20 , 21 in the upper part 12 are connected with the corresponding gas ducts 17 , 18 of the lower part 16 in this switching position of the valve device 11 . if an increased pressure rise occurs within the gas ducts 20 , 21 , a force will act at the interface 23 between the upper part 12 and the lower part 16 , and the upper part 12 is lifted off by this force from the lower part 16 , corresponding to fig4 , and excess gas can escape along arrow 24 . the limiting pressure at which the upper part 12 just lifts off can be set , for example , by selecting the rigidity of the sprig 22 . to set the closing force of the spring , an adjusting screw is provided , which is not shown specifically in fig4 and with which the pressing force of the spring 22 can be changed . fig5 schematically shows an alternative valve device 111 . this valve device is used on the top side of the anesthetic vaporizer 1 in a manner similar to valve device 11 . however , the valve device 111 has a clamping device 30 that remains open in the form of two tongues 27 with predetermined breaking points 28 . the tongues 27 have hook - shaped clamps 29 , with which the upper part 121 is pressed against the lower part 161 . when the pressure exceeds a predetermined limit value at the interface 231 between the upper part 121 and the lower part 161 , the predetermined breaking points 28 break and the clamps 29 release the upper part 121 . an immediate and permanent pressure release takes place . while specific embodiments of the invention have been shown and described in detail to illustrate the application of the principles of the invention , it will be understood that the invention may be embodied otherwise without departing from such principles .

US-21019705-A

improved shielded medical devices which minimize accidental needlesticks of the skin by an exposed contaminated needle are provided . the medical devices includes a hollow inner tube body having a pair of circumferential grooves on the outside thereof , and a slightly larger diameter hollow shield which is slidable relative to the inner tube . lugs circumferentially spaced about the rearward end of the shield yieldingly engage the rearward grooves during use of the medical device and thereby permit normal use of an exposed needle . thereafter the shield may be moved along the axis of the inner tube to a second position wherein the shield covers the now - contaminated needle . a plurality of axial slits in the rearward end of the shield in conjunction with a shoulder on the inner tube body forwardly adjacent a forward circumferential groove permit the medical devices to be assembled . the slits also permit the shield to move along the ramped outer wall of the inner tube during movement of the shield into its shielding position . in the unshielded position of the medical devices , a plurality of teeth on the forward end of the inner tube engage notches in the forward end of the outer shield to prevent rotational movement there - between during use of the medical devices .

fig1 - 4 show the basic structure of the improved safety - needled device of the invention , with fig5 a showing the syringe embodiment with the needle exposed and ready for use , and fig5 b showing the syringe embodiment after use with the outer shield in its forwardmost position in which the needle is covered , fig6 - 8 showing the blood collection tube holder of the invention , and fig9 showing the prefilled syringe embodiment of the invention . referring to fig1 - 4 , the improved safety medical device comprises two generally cylindrical pieces , a hollow inner tube 10 and an outer shield 12 , both pieces typically being made of molded plastic or other acceptable material . molded into the forward end of the outer surface of inner tube 10 is a rachet assembly 14 including locking teeth which are shown in detail in fig7 and 8 with reference to the blood collection tube holder embodiment . the inner surface of the forward end of inner tube 10 is also adapted to securely mate typically with a threaded structure to hold a standard hollow needle 16 shown with a removable needle cover 18 thereon inner tube 10 is further provided with a cavity 22 into which drugs , pharmaceuticals , blood or other fluids may be aspirated and then forced through needle 16 into a body , or into which a blood collection tube may be placed so that blood from the body may be drawn . a flange 24 is molded at the rearward end of inner tube 10 to act as a finger support while forcing the contents in the cavity into the body , or while withdrawing the needle from the patient , pharmaceutical vial , or other container . one important aspect of the invention is the precise geometry of the outer wall 42 of the inner tube 10 . circumferential grooves 36 and 38 are formed in wall 42 . an end wall 44 extends from the forwardmost end of wall 42 and supports ratchet assembly 14 which is integral therewith and is described in more detail hereinafter with respect to the blood collection tube holder embodiment shown in fig6 - 8 . at the junction of end wall 44 and wall 42 a shoulder 46 is formed , the rearward extension of shoulder 46 forming the forwardmost ledge 48 of circumferential groove 38 . the rearmost ledge 50 of groove 38 has a slightly smaller diameter than that of shoulder 46 , and as wall 42 extends rearward from ledge 50 , its outside diameter gradually decreases to form a sloped wall portion or ramp generally illustrated by 52 . thereafter , the wall 42 is of constant diameter until it reaches slightly raised shoulder 54 which forms the forwardmost ledge 56 of circumferential groove 36 . the forwardmost portion of flange 24 forms the rearwardmost ledge of groove 36 , and flange 24 has tine 57 for added finger support . the advantages of the entire construction will be described hereinafter it should be understood at this juncture , however , that the inner tube 10 is a single , preferably molded , integral unit . the outer shield 12 has an inside diameter which is slightly larger than the outer diameter of the inner tube 10 . the outer shield 12 is adapted to fit over inner tube 10 and to be slidable between a rearward position and a forward position ( as respectively shown in fig5 a and 5b for the syringe embodiment ). the outer shield 12 has a locking nozzle or ratchet means 26 molded into its inner surface at the forward end thereof , the locking nozzle including a plurality of locking notches , shown particularly in fig2 and 3 . locking nozzle 26 is preferably annular in shape and is connected to the outer cylindrical wall 70 of shield 12 by end wall 72 . a substantially annular opening 74 at the center of locking nozzle 26 is adapted to permit a standard needle 16 to extend therethrough when the shield 12 is in its closed position . as will be described , the locking nozzle 26 engages the locking teeth in the rachet assembly 14 when the shield 12 is in its rearward ( retracted ) position , thereby preventing rotation of the outer shield 12 relative to the inner tube 10 during an injection or phlebotomy . a flanged safety ridge 28 is formed near the forward end of outer shield 12 to assist the user in grasping the shield 12 and slidably moving it from its retracted position to its extended and locked position . the shield 12 also has at its rearmost end a plurality of circumferentially spaced axial slots 30 which form there - between tabs 32 , the tabs 32 being slightly flexible . formed on the inner surface of tabs 32 are a plurality of protrusions or lug members 34 ( seen in fig4 ) which are adapted to yieldingly engage a circumferential groove 36 preferably located at the rear end of inner tube 10 to thereby maintain the shield 12 in its retracted position ( shown in fig5 a with respect to the syringe embodiment ). the tabs 32 are sufficiently flexible to permit the lug members 34 to be forced out of groove 36 , and to permit the shield 12 to be moved forward manually to its extended or locked position ( shown in fig5 b with respect to the syringe embodiment ) in which the lug members 34 engage a second circumferential groove 38 . as will be described hereinafter , the construction of the shield 12 and inner tube 10 are such that the shield 12 , when in the extended locked position with lug members 34 locked into groove 38 , is extremely difficult to remove from the inner tube 10 , while during assembly , the shield 12 is slipped over tube 10 without lug members 34 locking into groove 38 . as aforementioned , a plurality of notches or grooves 76 , shown in fig2 and 3 , are formed on the inside wall of locking nozzle 26 . the notches 76 are designed and sized to mesh with the raised teeth 66 ( seen in fig7 ) extending from the outside of wall 60 of ratchet assembly 14 when shield 12 is positioned as shown in fig5 a with respect to the syringe embodiment . the meshing of the teeth 66 and notches 76 prevents rotation of shield 12 relative to inner tube 10 which could be distracting to the medical personnel using the medical device . while twenty - four notches 76 are shown extending completely about the inside wall of locking nozzle 26 , the exact number and shape may be varied and will be dependent on the size , shape and location of raised teeth 66 . with raised teeth 66 on opposite sides of wall 60 , the teeth 66 will mesh with notches 76 regardless of the relative circumferential alignment between inner tube 10 an outer shield 12 . another important feature of the invention is the plurality of forwardly extending slits 30 in the rearward portion of wall 70 of shield 12 . as shown , eight such slits 30 are provided , although the exact number will depend on the size of the shield 12 and the flexibility of the plastic or other acceptable material from which it is constructed as seen in fig1 and 4 , the slits 30 in the shield wall form slightly flexible tab - like members 32 at the rear end of the shield . as seen best in fig4 a plurality of lug members or protrusions 34 extend radially inwardly from each of the tabs 32 , and also extend circumferentially along each tab 32 . lug members 34 are adapted to fit within and lockingly engage circumferential grooves 36 and 38 of inner tube 10 . the flexibility of tab 32 and their corresponding lug members 34 provide advantages in assembling the shielded medical device , and in moving the shield 12 from its unshielded ( open ) to its shielded ( closed ) position . the precise size and shape of lug members 34 may be changed to suit the particular situation . turning to fig5 a and 5b , the safety - needled syringe embodiment of the invention is shown , with like numbers indicating like parts . in fig5 a , the outer shield 12 is in its retracted position relative to the inner syringe tube 10 such that needle 16 is unshielded ratchet means 14 of the syringe tube 10 , and locking nozzle 26 of the outer shield 12 are engaged to prevent rotation of the shield relative to the inner syringe tube 10 , while lug member 34 of tabs 32 are seated in 3 circumferential groove 36 . as shown in fig5 a and 5b , the inside of inner syringe tube 10 as arranged to be generally cylindrical in shape , and at its forward end is shaped to accommodate the typically rubber end of a standard plunger 20 . thus , chamber 22 of the syringe tube 10 is shown accepting plunger 20 which will either force the contents of chamber 22 through a small annular opening 58a in the ratchet assembly 14 and into and through the needle 16 , or aspirate a fluid through the needle 16 , the small annular opening 58a in the ratchet assembly , and into the chamber 22 . as seen in fig5 b , graduated markings 40 typically in cc measurements are placed on shield 12 for clear visibility , although since shield 12 is preferably transparent , the markings 40 may be placed on the syringe tube 10 . after injection , the rubber end of plunger 20 is seated at the accommodating front end of the chamber 22 . by applying some force to the shield 12 , shield 12 is moved to the position indicated in fig5 b such that lugs 34 are seated in circumferential groove 38 , and the needle 16 is shielded by shield 12 . shoulder 46 and ledge 50 of the syringe tube 10 keep the lugs 34 of shield 12 firmly in place so that shield 12 cannot accidentally retract or fall off of the syringe tube 10 and thereby reexpose the contaminated needle it is of note with respect to fig5 a and 5b , that the front end of the shield 12 extends further than is shown in fig1 so that the ratchet means 26 of the shield 12 can properly engage ratchet means 14 of the syringe tube 10 . thus , while the shield 12 is essentially identical for all of the medical devices of the invention , its exact length and shape at the front end is dependent on the device with which it is to engage so as to prevent rotation . turning to fig6 - 8 , the inner tube 10 of the blood collection tube bolder embodiment of the invention is provided . as is seen in fig7 rachet assembly 14 has an annular opening 58b at the center thereof . also , as seen in fig6 the ratchet 14 assembly of inner tube 10 of the blood collection tube holder has a cylindrical forwardly extending wall 60 which is provided at the inside circumference thereof with threads 62 or other means by which a standard hollow needle may be attached and communicate through annular opening 58b with cavity 22 . for the blood collection tube holder device , inner tube 10 is also provided with a rearwardly extending cylindrical wall 64 may be shaped to receive the forward end of a vacuum blood collection vial ( not shown ) in sealing engagement therebetween . it should be appreciated that in the blood collection tube holder embodiment , the flange 28 on the outer shield 12 not only provides a safety ridge for grasping and pushing shield 12 , but may be used as a vacuum vial penetration indicator line . thus , the self - sealing rubber end of the vacuum vial may be axially inserted up until that point without the back point of the standard phlebotomy needle puncturing the same . as aforementioned , the rachet assembly 14 of the inner tube 10 includes a plurality of raised teeth 66 , which as seen in fig7 and 8 extend outwardly from the outside surface of wall 60 of rachet assembly 14 . five teeth 66 are shown on diametrically opposed sides of wall 60 , but the exact number and exact location of the teeth 66 may be varied . the teeth 66 , as was afore - described , mesh with notches 76 of in the locking nozzle 26 of shield 12 to prevent rotation of shield 12 relative to inner tube 10 when the shield is in its retracted position . the inner tube 110 of the prefilled safety syringe embodiment of the invention is seen in fig9 a , with the disposable plunger arm 105 seen in fig9 b . ( in this embodiment corresponding elements will have corresponding numbers with the numbers of fig9 a being greater by one hundred ). the inner tube 110 of fig9 a combines many of the standard features of a prefilled syringe with the afore - described inner tube features of the instant safety - needled invention thus , for purposes of the standard prefilled syringe , the inner tube 110 is preferably made of or lined with glass . the medicated liquid 121 is maintained in chamber 122 which is bounded by the cylindrical wall 142 , a shaped metal cap 145 having an hermetic seal 147 , and a rubber plunger seal 149 having a male threaded member 151 extending therefrom . also , for purposes of the standard prefilled syringe , the rear end of the inner tube 110 is provided with a groove 161 for a preferably plastic snap - on flange 163 , while the front end metal cap 145 is arranged to mate with a needle hub 165 having a ridge ring 167 on one end for mating with the metal cap 145 , and means for accepting and holding a double pointed needle 116 on the other end . typically , the needle 116 is provided with a protective cover 118 which must be removed before an injection . a disposable plunger arm 105 seen in fig9 b is provided with a female thread member 181 which is screwed onto the male threaded member 151 of the inner tube 110 prior to injection . after mating , force may be applied to the plunger arm 105 so as to force the medicated liquid out through the double pointed needle 116 . as seen in fig9 a , the inner tube 110 also includes the safety - needled features . thus , provided in the outer surface of the inner tube 110 are front and rear grooves 138 and 136 into which the lugs of an outer shield may extend , with front groove 138 being deeper than rear groove 136 . also , preferably , the outer surface of inner tube 110 is provided with a shoulder 146 which prevents the outer shield from leaving the front groove 138 , as well as a ramped surface 152 which helps provide the clicking / locking action . upon assembly of any of the shielded medical devices , preferably by machine in an automated production , the open end of the outer shield 12 is forced over the shoulder 46 ( 146 ) of the inner tube 10 ( 110 ), ( fig9 numbers not being listed hereafter ). the lug members 34 attached to tabs 32 initially contact the sloped wall portion 90 ( fig1 ) and the sloped wall portion 90 forces the flexible tabs 32 outwardly in a fanlike manner . as the lug members 34 pass over and by raised shoulder 46 , they instantaneously remain spread , both due to the contraction time required to reassume an unstressed position and due to the position assumed with the tabs angling away from wall 42 of tube 10 , such that they can be quickly moved past groove 38 without falling into groove 38 . as the shield 12 is pushed rearwardly over the inner tube 10 , the lug members 34 press against ramp 52 which is of decreasing diameter , i . e . the tabs 32 are no longer flexed outwardly as a result of the reduced diameter of wall 42 , and become parallel . the lug members 34 at the end of the shield 12 ultimately pass over slightly raised shoulder 54 , and lug members 34 fall into circumferential groove 36 , where the shield 12 is substantially fixed as shown in fig5 a . after the medical device is used and becomes contaminated , the user removes the needle from the patient or other contaminated area and presses forward on safety ridge 28 . because circumferential groove 36 is not as deep as circumferential groove 38 , lug members 34 are not deeply seated in circumferential groove 36 . since tabs 32 are slightly flexible , it does not take a great deal of force to push the lugs 34 out of groove 36 and over raised shoulder 54 . as the shield 12 is pushed forward , the lug members 34 contact ramp 52 in a direction in which the diameter of the wall 42 is increasing . this provides increased friction and tension on the tabs 32 , i . e ., the user is aware of the increase in force needed to keep the shield 12 moving forward . the lug members 34 eventually fall into circumferential groove 38 with an audible click , providing a positive indication of locking beyond the visual indication . because of its depth and because of the increased diameter of raised shoulder 46 , groove 38 retains the shield fixed as shown in fig5 b . it is difficult to remove the shield once it is locked into circumferential groove 38 , and a positive lock is assured , completely protecting medical personnel and others against needlestick injuries from the contaminated needle 16 . the shielded medical device is then safely discarded in accord with established procedures . the shielded safety medical devices of this invention may be used in numerous circumstances and for differing purposes , all of which are within the scope of this invention a common use would be by a phlebotomist ( clinician ) for obtaining blood samples from a patient . for this usage the phlebotomist ( clinician ) screws a capped sterile blood collection needle 16 into the threads 62 of inner tube 10 . typically , the phlebotomy needle ( not shown ) extends a short distance into cavity 22 of the inner tube 10 , and a vacuum vial ( not shown ) having a rubber or plastic stopper is inserted into the tube 10 rather than a plunger . the stopper of the vacuum vial is penetrated by contact with the rearward extension of the needle , and blood is drawn into the vacuum vial through the needle which has been inserted into a vein of the patient . once the blood sample is taken ( if desired , several tubes of blood may be obtained ), the needle is removed from the patient , the vacuum vial ( s ) now filled with a blood sample ( s ) is removed from the inner tube 10 , and the phlebotomist ( clinician ) then slides the shield 12 over the inner tube 10 until the shield clicks and locks in place , thereby protecting personnel from injury from the contaminated needle or blood . the shielded blood collection tube holder is then safely disposed of , protecting against potential injuries an inadvertent contamination . when used simply as a syringe , the clinician attaches the appropriate size needle to the syringe tube , removes the end cap and aspirates the required drug , medication , or blood into the syringe . the drug , medication , or other liquid is then administered to the patient directly by injection or through i . v . administration lines . upon removing the needle from the patient , the safety shield is moved forward until the lugs of the tabs of the outer shield click and lock securely in the forward groove in the syringe tube . with such a procedure , the shield surrounds the needle as shown in fig5 b , and the syringe and contaminated needle may then be safely discarded . similar procedures are followed with safety syringes with needles already attached , or with pre - filled syringes which ordinarily require loading the syringe into a plunger mechanism in order to administer the drugs , medications , or other fluids contained therein . in either case , the syringe tube and shield of this invention are useful . it is also within the scope of this invention to use its teachings with intravenous catheters . there has been described and illustrated herein various improved shielded safety medical devices . while particular embodiments of the invention have been described , it is not intended that the invention be limited thereby , as it is intended that the invention be broad in scope . thus , for example , while the invention was described as comprising essentially two unitary pieces , it will be appreciated that several pieces could be utilized to form either the tube or the shield . moreover , while the wall of the tube is preferably formed with a ramp to cause the shield to &# 34 ; click &# 34 ; when the lugs of the shield snap into the circumferential groove of the tube , it will be appreciated that the ramp is not essential to the invention . further , while the locations of the grooves in the inner tube of the embodiments were described as being at the forward and rear ends of the inner tube , those skilled in the art will appreciate that the exact location is not critical provided the contaminated needle is shielded by the shield after use . thus , if the needle is short relative to the shield , the front groove can be located further back on the inner tube . without jeopardizing the effectiveness of the device . likewise , if the inner tube is long relative to the shield , the rear groove can be located away from the rear of the inner tube without the shield interfering with the needle when the shield is in its retracted position . further yet , while the rear portion of the outer shield was described as having axial &# 34 ; slits &# 34 ;, the slits may be thought of as &# 34 ; slots &# 34 ;. thus , for purposes herein , the thickness of those slits or slots is a matter of choice and the terminology is to be read broadly such that slits and slots are equivalent . therefore , it will be apparent to those skilled in the art that yet other changes and modifications may be made to the invention as described without departing from the scope of the invention as so claimed .

US-16256988-A

irrigation fluid is aspirated from an eye and through an aspiration instrument by operating a vacuum pump , including moving first and second plungers between respective suction strokes and discharge strokes . vacuum pressure at an input side of the pump is maintained at a desired vacuum pressure setting by controlling speeds and directions of the plungers , and controlling positions of input and output valves communicating with cylinders in which the plungers move . controlling is based on the pressure setting and measured pressures in the cylinders . vacuum pressure is maintained while transitioning from the suction stroke of the first plunger to the suction stroke of the second plunger , by synchronizing respective positions of the plungers and the valves , such that initiation of the suction stroke of the second plunger during the transitioning is delayed until a vacuum pressure in the second cylinder is equal to a vacuum pressure in the first cylinder .

disclosed is a dual cylinder pump that is used to create a vacuum in an aspiration tube of a medical system . the pump includes a first plunger that moves within a first cylinder and a second plunger that moves within a second cylinder . movement of the plungers is controlled by a motor assembly . the pump includes valves that control the flow of fluid into and out of the cylinders so that one cylinder is pulling fluid from the aspiration tube while the other cylinder is discharging fluid . in this manner the pump is continuously pulling vacuum , thereby preventing vacuum surges found in peristaltic pumps of the prior art . additionally , the pump is relatively energy efficient and does not require a separate nitrogen tank as required by commercially available venturi pumps of the prior art . the pump can be constructed as a cartridge that can be removed and disposed . referring to the drawings more particularly by reference numbers , fig1 shows an embodiment of a medical system 10 of the present invention . the system 10 may be used by a surgeon to perform ophthalmic medical procedures such as cataract lens removal , or retina reattachment . the system 10 may include a surgical aspiration instrument 12 that is coupled to an aspiration system 14 . the aspiration instrument 12 may include a tip 16 that extends from a handpiece 18 and can be held by a surgeon . the tip 16 can be inserted into the eye of a patient . the tip 16 is hollow and thereby defines an inner channel 17 through which irrigation fluid and possibly tissue may flow . accordingly , the inner channel 17 extends through the tip 16 and , in the illustrated example , through the handpiece 18 to the rear of the handpiece 18 opposite to the tip 16 . the aspiration system 14 may include an aspiration line or conduit 20 that is coupled to the aspiration instrument 12 . the aspiration line 20 is connected to a vacuum pump 22 and a collection canister 24 . the vacuum pump 22 creates a vacuum pressure within the aspiration line 20 and a flow of fluid from the aspiration instrument 12 to the collection canister 24 . the aspiration system 14 can pull ( e . g ., evacuate or aspirate ) emulsified tissue and fluid from the aspiration instrument 12 and into the collection canister 24 . in the illustrated example , the aspiration line 20 includes a first aspiration tube 21 fluidly interconnecting the inner channel 17 of the aspiration instrument 12 and the input side of the vacuum pump 22 , and a second aspiration tube 23 fluidly interconnecting the output side of the vacuum pump 22 and the collection canister 24 . the system 10 may include one or more control devices . in the illustrated example , the system 10 includes a controller unit 26 that is connected to the aspiration instrument 12 and the vacuum pump 22 . the system 10 may further include a foot pedal 28 that is connected to the controller unit 26 . the surgeon can control the aspiration instrument 12 and / or the pump 22 by manipulating an input 27 or 29 of the controller unit 26 and / or the foot pedal 28 , such as to adjust the vacuum pressure in the first aspiration tube 21 to a desired vacuum pressure setting and readjust the vacuum pressure to new settings as needed during a particular surgical procedure . the controller unit 26 may be an electronic controller and include a processor , memory , etc . ( not shown ) that can operate the pump 22 in synchronization with the aspiration instrument 12 . although the foot pedal 28 is shown as being connected to the controller unit 26 , the foot pedal 28 may be connected directly to the pump 22 and / or aspiration instrument 12 . fig2 shows an embodiment of the vacuum pump 22 . the pump 22 may include a housing 30 that has a first cylinder 32 and a second cylinder 34 . the housing 30 also provides a fluid input and a fluid output . in the illustrated example , the fluid input includes a first input port 36 and a second input port 37 , and the fluid output includes a first output port 38 and a second output port 39 . a manifold tube 46 may be utilized to split the fluid flow from the first aspiration tube 21 into respective flows into the input ports 36 and 37 . thus , the first and second input ports 36 and 37 provide fluid communication from the first aspiration tube 21 ( via the manifold tube 46 ) to the first and second cylinders 32 and 34 , respectively . likewise , the respective flows from the output ports 38 and 39 may be combined by a manifold tube ( not shown ) or otherwise connected to the second aspiration tube 23 in any suitable manner . thus , the first and second output ports 38 and 39 provide fluid communication from the first and second cylinders 32 and 34 , respectively , to the second aspiration tube 23 . also in the illustrated example , the housing 30 further includes inlet lines ( channels , conduits , or the like ) 40 and 42 in fluid communication with the first and second cylinders 32 and 34 , respectively , and with the respective input ports 36 and 37 . the housing 30 further includes outlet lines 54 and 56 in fluid communication with the first and second cylinders 32 and 34 , respectively , and with the respective output ports 38 and 39 . the pump 22 may have a first valve assembly 44 that controls the flow of fluid into the first and second cylinders 32 and 34 , from the first aspiration tube 21 and , in the illustrated example , via the input ports 36 and 37 and manifold tube 46 . as previously noted , the manifold tube 46 is connected to the first aspiration tube 21 of the aspiration system 14 ( fig1 ). the first valve assembly 44 may include a first input valve 48 that interfaces with the first inlet line 40 to control the flow of fluid into the first cylinder 32 , and a second input valve 50 that interfaces with the second inlet line 42 to control the flow of fluid into the second cylinder 34 . the pump 22 may further have a second valve assembly 52 that controls the flow of fluid from the first and second cylinders 32 and 34 and respectively through the outlet lines 54 and 56 of the housing 30 . as previously noted , the outlet lines 54 and 56 are connected to the second aspiration tube 23 of the aspiration system 14 ( fig1 ) via the output ports 38 and 39 . the second valve assembly 52 may include a first output valve 58 that interfaces with the first outlet line 38 to control the flow of fluid from the first cylinder 32 , and a second output valve 60 that interfaces with the second outlet line 39 to control the flow of fluid from the second cylinder 34 . the valves 48 , 50 , 58 and 60 may be controlled by actuators or motors that are connected to and controlled by the controller unit 26 shown in fig1 . the pump 22 may include pressure transducers or sensors 62 and 64 that sense the pressure within the first and second cylinders 32 and 34 , respectively . the pressure transducers 62 and 64 can be connected to the controller unit 26 shown in fig1 , and provide pressure feedback information that can be used in a feedback control loop of the pump 22 . the pump 22 includes a first plunger 66 that moves within the first cylinder 32 and a second plunger 68 that moves within the second cylinder 34 . the plungers 66 and 68 are moved by a motor assembly 70 . the motor assembly 70 may include a first motor or motor unit 72 that moves the first plunger 66 and a second motor or motor unit 74 that moves the second plunger 68 . the motors 72 and 74 may move the plungers 66 and 68 out of phase relative to each other . by way of example , the plungers 66 and 68 may move 180 degrees out of phase relative to each other . the motors 72 and 74 may be connected to the controller unit 26 which controls the timing and phase of the plungers 66 and 68 . although two motors 72 and 74 are shown and described , it is to be understood that the plungers could be coupled to a single motor . the motors 72 and 74 may be attached to the plungers 66 and 68 by couplers 76 and 78 . the couplers 76 and 78 may be of the quick disconnect type so that the plungers 66 and 68 and the housing 30 can be detached from the motor assembly 70 . this allows the housing 30 and plungers 66 and 68 to be packaged as a cartridge that can be detached after a medical procedure . the motor assembly 70 may include a first linkage 82 connected to the first plunger 66 and a second linkage 84 connected to the second plunger 68 . thus , during the operation of the motor assembly 70 , movement of the first linkage 82 is translated into movement of the first plunger 66 alternately through its suction and discharge strokes , and movement of the second linkage 84 is translated into movement of the second plunger 68 alternately through its suction and discharge strokes . in the illustrated example , the first motor 72 is connected to the first linkage 82 and the second motor 74 is connected to the second linkage 84 . in the illustrated example , the first linkage 82 is releasably connected to the first plunger 66 by the first coupler 76 , and the second linkage 84 is releasably connected to the second plunger 68 by the second coupler 78 . the plungers 66 and 68 may be of the syringe type that can be readily discarded and replaced . the housing 30 can be sterilized for reuse in the system 10 . the valve actuators that actively control the valves 48 , 50 , 58 and 60 and the pressure transducers 62 and 64 may also be attached to the housing 30 in a sealed and readily detachable manner so that these components do not have to be sterilized after each procedure . the controller unit 26 may control the motors 72 and 74 and the 20 valve assemblies 44 and 52 in the following manner . the first input valve 48 may be opened to provide fluid communication between the manifold tube 46 and the first cylinder 32 . the second input valve 50 is closed . the first motor 72 may pull the first plunger 66 in a direction indicated by the arrow . movement of the plunger 66 pulls fluid into the first cylinder 32 . when the first plunger 66 reaches an end of travel ( suction stroke of first plunger 66 ), the first input valve 48 is closed and the second input valve 50 is opened . the second motor 74 then pulls the second plunger 68 to draw fluid into the second cylinder 34 . during this second plunger movement the first motor 72 pushes the first plunger 66 ( discharge stroke of first plunger 66 ). the first output valve 58 is opened so that the fluid within the first cylinder 32 is pushed out of the pump 22 . the motors 72 and 74 and valves 48 , 50 , 58 and 60 are operated so that one of the cylinders 32 or 34 is pulling in fluid while the other cylinder 34 or 32 is pushing out fluid . in this manner a continuous vacuum is created in the aspiration line 20 ( e . g ., the first and second aspiration tubes 21 and 23 ). there are not sudden surges as found in prior art peristaltic pumps . to maintain a continuous vacuum level , the second plunger 68 may begin to pull a vacuum in the second cylinder 34 as the first plunger 66 nears the end of travel in the first cylinder 32 during the discharge stroke of the first plunger 66 . the second input valve 50 may be closed during movement of the second plunger 68 until the pressure transducers 62 and 64 sense the same pressure , wherein the second input valve 50 is opened and the first input valve 48 is closed . while certain exemplary embodiments have been described and shown in the accompanying drawings , it is to be understood that such embodiments are merely illustrative of and not restrictive on the broad invention , and that this invention not be limited to the specific constructions and arrangements shown and described , since various other modifications may occur to those ordinarily skilled in the art . for example , although multiple valves 48 , 50 , and 60 are shown and described , it is to be understood that the pump 22 may have other valve arrangements . by way of example the pump 22 may have a single four - way valve .

US-201113036955-A

breakfast cereal products coated with a cold - water - soluble coating made from milk solids or high protein , vitamins , and mineral supplement powders adhering to the surface of the cereal via an adhesive or conditions making the surface of the cereal adherent are described . the cereal itself may contain in its basic recipe milk solids , fibers , sugars , fats and carbohydrates , various proteins and minerals , thus classifying the basic cereal formula as a high energy and / or high protein and / or high fiber cereal product , which may be fortified with other essential minerals and vitamins used commonly as dietary supplements . this product is processed in a manner so that a coating is applied composed of such products which remain soluble in cold water at the time of consumption , even after drying and eliminates the need for liquid milk requiring only tap water to generate a similar taste , color , and texture , as well as mouth sensation , at the time of consumption of the cereal .

it was difficult until now to achieve the above desired characteristics within a cereal system , due to low water content and low water activity present in common cereals . because of this , any coating added to the surface had to be in a slurry form , or an adhesive such as water or oil was added to maintain the coating until it was dried for a second time and reduced the water activity of the total cereal to a shelf - stable condition . we have found that by preferably starting with high protein cereal ( 12 % and up ) within the initial recipe , the cereal particulates are more resistant to water activity , and thus do not readily absorb moisture from the surroundings . this allows the cereal to be sprayed with a water soluble adhesive such as carboxyl methyl cellulose ( cmc ), or various gums and hydrocolloids , such as guar gum , xanthan , gum arabic , etc . either in a slurry form containing water and part or all of the coating compound , or by coating the surface of the cereal piece followed by powdering the sticky surface with the coating compound . the adhesive preferably has a water activity of less than 0 . 75 and is applied hot . this allows the water activity at the surface of the cereal to remain at lower values , thus allowing the adhesive to be dried slowly at low temperatures without changing the characteristics of the components of the surface coating ( such as denaturation of the proteins ) until the cereal is totally dried at low temperatures to the desired and stable condition . the lower water activity within the slurry that carries the solids containing the various components of the coating is due to the matrix formed by the various gums and hydrocolloids affixed to the surface of the cereal , thus releasing the water to higher temperature air during drying rather than to the cereal base . i have also found that sugars and syrups are preferred as adhesives in complying with the above required conditions . the sugars or syrups are applied in a slurry by a hot spray method onto the dried cereal . particularly useful are corn syrup or molasses . the powdered coating is then added onto the adhesive . the drying technique of such cereals is also important in the protection of the solubility of the protein coating in water . if the temperature of the drying is not considered and is at high settings ( beyond 185 ° f . ), then the effect on the insolubility of the proteins becomes greater , causing insolubility within the water medium during consumption . the total water activity of the cereal and the coating at the time of packaging should be below 5 . 2 . under this condition , the total water content of the coated piece , i . e . product , may be within 2 - 8 %. this level of water within the cereal mandates that , after the production of the cereal , it needs to be dried or even toasted to keep the water content of the system at very low levels so that when the coating is introduced to the surface , the remaining drying which is being conducted will remove the moisture from the surface of the cereal and exclusively from the coated material . this step allows the coating to adhere to the surface of the cereal very tightly , and only to be released when the moisture is introduced at high levels . if care is not taken to coat and dry the cereal as outlined in the above steps and conditions , the resulting product will end up in a soggy condition after it is packaged , and the migration and release of the moisture , either within the cereal itself or from the coating to the cereal , will become apparent and affect the texture of the final product . processing techniques for manufacturing breakfast cereals are well known . the purpose of the present description is to specify the unique manner whereby the recipe of the cereal being manufactured using , for example , an extrusion system , incorporates proteins , carbohydrates , sugars , fats , and fibers from various sources , such as from legumes ( for example soya , peanuts , sweet peas , and the like ) or cereals such as wheat , corn , barley , rice , oat , and the like , or tubers such as potatoes , or any other types of proteins , may be applied to this product and not mentioned in the above listing or the modification of the above ingredients whether chemically , mechanically , thermally or electromagnetically . the cereal is produced with specific formulations incorporating one or more of the above sources with proteins from 1 - 28 %, sugars from 1 - 20 %, carbohydrates from 30 - 85 %, fats from 0 . 5 - 8 %, fibers from 0 . 5 - 16 % and other matter modified or hydrolyzed from any of the above sources at ranges from 0 - 65 % by dry weight basis . optionally , liquids made of fats , oils and other hydrophobic materials may be applied to isolate the cereal from the surface coating of a cold - water soluble coating . the cereal is then toasted and / or dried to moistures of less than 5 % by weight . an adhesive such as maltodextrin , or gum solutions , or any compound or compounds possessing adhesive characteristics and having a low water activity of approximately 0 . 75 or less is then added to the surface of the dried or toasted cereal . the cereal surface can be further toasted and dried , followed by application of the cold - water soluble powder or slurry derived from various sources such as powdered soya milk , milk powder , or a mixture of various protein sources , emulsifiers , and / or whiteners possessing liquid - milk - mimicking characteristics when water is added . the cereal is then further dried with high volume air flowing dryers at low temperatures of 130 °- 195 ° f . the final product is then packaged after it has reached room temperature . alternatively a slurry containing adhesive and the water soluble powder may be spray coated on the dried or toasted cereal . the type of protein and other cold - water soluble compounds applied to the surface may be chosen from types of ingredients that do not change the solubility of the coating ingredient powder when it is subjected to the final drying temperatures cited above . the ingredients for such a coating , including whiteners , may include some or all of the following : sodium caseinate , partially hydrogenated soybean oil , corn syrup solids , dipotassium phosphate , mono - and diglycerides , lecithin , soy protein isolate , cocoa powder , dried honey , powdered almond butter , pectin , bran ( corn , soya , rice , etc . ), soya flour , maltodextrin , skim milk powder , cellulose gel , non - fat dry milk , sucrose , dextrose , sodium triphosphate , calcium casemate , modified corn starch , carageenan , artificial or natural flavors , fructose , gum arabic , egg white . thickening agents may also be added to the surface coating so that , at the time of consumption with water , the coating forms a slightly thicker consistency than water , thus giving the mouth - feel and the texture of milk and cereal . minerals and vitamins combined with the coating may include calcium carbonate , magnesium phosphate , potassium chloride , calcium phosphate , sodium ascorbate , vitamin e acetate , niacinamide , zinc sulfate , calcium pantothenate , ferrous sulfate , beta carotene , vitamin a palmitate , magnesium sulfate , copper gluconate , pyridoxine , hydrochloride , riboflavin , thiamine hydrochloride , folic acid , biotin , sodium molybdate , potassium iodine , chromium chloride , sodium selenite , phylloquinone ( vitamin k1 ), vitamin b12 ( cyanocobalamin ), vitamin d3 ( cholecalciferol ), vitamin b6 , thiamine mononitrate , folic acid , riboflavin , calcium succinate , zinc oxide , and zinc gluconate . this surface coating can also be composed of whole or partial soya milk powder , other proteins from non - dairy sources , vitamins and minerals and appropriate whiteners , coloring agent and adhering compound to produce a cereal with soya milk for those who are lactose intolerant . particularly useful surface coating powders are those which are commercially available pre - formulated high protein , milk or milk - substitute powders such as for example : super megamass ® 2000 from weider nutrition group , salt lake city , utah ; similac ® powdered formulas , e . g . low - iron infant formula , from ross products division , abbott laboratories , columbus , ohio ; ultra slim fast ® in a variety of flavors , e . g . cafe mocha , from slim  fast food company , west palm beach , fl . ; and enfamil ® products , e . g . next step ™, from mead johnson nutritionals , evansville , ind . the surface coating may have to be reapplied a number of times in order to accumulate enough water - soluble powder so that , when water is added , the product will have the appearance of liquid - milk - containing cereal . the recipe for the powder coating can be formulated in such a manner as to be considered full - fat , low - fat , and no - fat to result in a cereal with a milk - like coating which is full -, low -, or no - fat in content . such products , with the appropriate coatings and being nutritionally balanced , are formulated in such manner that if the product is fine ground after final drying , it can be consumed in a porridge or liquid drink by the addition of high amounts of water to the powder in order to dilute the product . it can then be consumed in such manner , with a relatively low viscosity of approximately 50 centipoise at water content of 5 : 1 parts of fine grind . the addition of cocoa and other flavorings can produce a final product which is suited to a given taste preference , such as chocolate milk , strawberry flavoring , peach , berry , and even coffee or tea flavoring . the present invention as above - described provides the following features , advantages and benefits : a traditional cereal made for human consumption with a formulation containing high amounts of proteins from single or various sources , thus giving a harder texture to the traditional cereal and making the final product less absorbent to water . the total protein content of the cereal can be from 1 - 38 % based on the dry weight . a coated cereal with an adhesive to cause the powder or the liquid being applied to the surface to hold onto the abundant amount of compounds needed to color the water added to the product , which will mix and dissolve in water giving the appearance , texture and taste as well as color of milk , and will contain enough compounds necessary to add a milk - like flavor and mouth - feel to the total cereal during consumption , wherein the coated cereal will provide a complete nutritional balance for the consumer based on the consumption of regular cereal and milk . a cereal with the consistency of cereal in milk , in color , or flavor , or mouth - feel , or all or some of the above characteristics when water is added to the cereal in the bowl . a cereal in water which can be used as a nutritional food for humans and infants because the coating can contain additional vitamins and minerals to fit the specified target . a cereal which maintains its texture in water and releases the water - soluble coating into the water within a very short time of a few seconds to a few minutes . a coated cereal that can be heat treated after water is added to the bowl in order to produce a porridge that is high in nutrition and soft in texture and high in proteins , vitamins and / or minerals . a product which can be ground to powder and used as a food supplement and / or complete nutritional food for diets . a specific cereal coated with a soya milk base incorporating vitamins and minerals , whiteners , and adhering agents for those who are lactose intolerant . a coated cereal that can be formulated in such a manner that it can be considered full - fat , low - fat , or no - fat , resulting in a cereal with a milk - like coating which is full -, low -, or no fat content . other flavorings and colorants , natural or artificial , may be added to produce a final product which becomes cereal in milk with cocoa or various fruits , such as strawberry , peach , or other sources / flavors such as coffee , tea or shakes , as well as candy flavorings such as bubble gum , candy cane , candy apple , and the like .

US-94631897-A

blood treatment system and method for high rate hemofiltration ensures against pyrogenic patient reaction by providing various mechanisms for filtering replacement fluid to remove endotoxins and other safety features including detecting incorrect fluid administration .

referring to fig1 , a filter 160 filters fluid from a source of fluid 150 to generate a batch of infusible replacement fluid 130 . the filter 160 may be , and preferably is , a microporous filter that blocks pyrogens and allows the passage of dissolved electrolytes and water . the latter may provide an infusible fluid free of all pyrogens , however , in practice , the pyrogen concentration must be reduced , but not necessarily eliminated since total elimination is not practical . the most common type of pyrogen is endotoxins , which may be present even in sterilized fluids . in hemofiltration , a large quantity of fluid is drawn from the patient and replaced with replacement fluid . compared to dialysis , the quantity actually removed and replaced with replacement fluid tends to be high . as a consequence , it is desirable to provide replacement fluid that has a lower concentration of pyrogens than may be allowed in other infusible fluids and what may cross the membrane of a dialysis system . thus , a filter effective to reduce endotoxins to levels at least as low as 0 . 03 endotoxin units per 25 ml . should be provided for the filter 160 . the result of the filtration process is the sterilization and cleansing of endotoxins and particulate pyrogens in the raw fluid from the source of fluid 150 . the source of fluid 150 may be a container 196 of fluid approved for injection or non - sterile replacement fluid . it may also be one or more containers of constituents which , when combined , form a proper replacement fluid ( not shown ) or a continuous source such as a tap water that is combined or has been combined with electrolyte concentrate ( not shown ). the starting fluid may be a function of the type of filter 160 used . for example , when processing fluid with a relatively large concentration of particulate pyrogens , for example bacteria , it is desirable to use a very large filter to ensure that its filtering performance is not compromised . in a preferred embodiment , a small replacement filter is used ( since they tend to be costly ) and the source fluid is fluid that has already been filtered to achieve low levels of pyrogens . one or more conduit elements form a line 120 to convey the source fluid 150 through the filter 160 and into a batch container 147 . the latter may be any type of sterile , preferably disposable container , for example , a large iv bag . it may also include a number of such containers appropriately interconnected to permit flow into and out of them in the fashion of container 147 . included in the conveyance from source fluid 150 to infusible replacement fluid 130 may be a pump 190 , such as a peristaltic pump . the pressure at an outlet of the filter 160 may be sensed by a pressure sensor 162 and the pump 190 controlled by a controller 170 to insure a predefined transmembrane pressure ( tmp ) threshold of the filter 160 is not breached . the tmp may be maintained at a maximum safe level to maximize throughput . note that complexity may be avoided if the source fluid 150 is arranged such as to maintain a desired tmp at the filter 160 without the need of a pump 190 or pressure sensor 162 . for example , the source fluid 150 may be provided by a batch container elevated at a certain height to provide a desired head . note that a control valve 165 or a speed of the pump 190 may be used to regulate the flow rate to maintain desired tmp limits . a control / shutoff valve 180 may provide the controller 170 the ability to stop the flow of fluid through the filter 160 once a desired volume is reached . a heater 185 may be provided to warm the filtered replacement fluid 130 to prepare it for use . an insulated container 145 may be used to reduce heat loss so that heater 185 can be a relatively low power type . the heater 185 may be controlled by the controller 170 to ensure the replacement fluid 130 is at a desired temperature when required to be used . alternatively the heater 185 can be controlled by an independent device actuated by , for example , a pressure sensor ( for example as shown at 186 in fig1 ) triggered by the flow of fluid into the batch container 147 , a timer ( not shown ) settable to trigger based on a predefined treatment time , or some other means . preferably , in either case , a temperature regulator ( e . g ., a temperature sensor 183 combined with logic in controller 170 ) regulates power to the heater to ensure a required temperature is maintained and not exceeded . the temperature sensor 183 may be used to sense the quantity of filtered replacement fluid by the rate of detected temperature increase versus heater output . the temperature sensor 183 , heater 185 , and filtered replacement fluid 130 can be modeled in any desired fashion . for example one may neglect all but the thermal mass of the rf , assume perfect heat transfer ( including assuming the rf fluid to be isothermal ). then , the mass is given by the product of the temperature change , the thermal capacitance of the fluid , and the heat output rate of the heater . more complex theoretical or empirical algorithms would be a simple matter to derive and implement , for example the temperature variation can be fitted to the transient exponential that governs for instantaneous uniform heating from a plane source as the heater is started , taking temperature data points before substantial convection starts . the mass may also be determined by means of a contact - type pressure sensor 186 ( e . g ., strain gage attached to a bendable plate and calibrated against mass ). once the mass of fluid is calculated to be below a certain level , the controller 170 may be programmed to respond in accord with the assumption the filtered replacement fluid is exhausted . equivalently , the controller 170 may simply respond to some predefined rate of temperature rise of the temperature sensor 183 . when the temperature of the filtered replacement fluid 130 is raised , dissolved gas may come out of solution . this may cause bubbles to accumulate inside the replacement fluid container 147 , which is undesirable because of the risk of infusing bubbles into the patient &# 39 ; s bloodstream . to help ameliorate that problem , a vibrator or ultrasonic transducer 184 may be provided to cause bubbles to coalesce and rise to a top of the container 147 . as a result , bubble - free replacement fluid may be drawn through the outlet 148 . a connector 195 may be provided for connecting the source fluid to the line 120 . the connector may be a luer , spike , threaded adapter , or any other suitable type . although the various controls indicated above are shown to be controlled an automatic controller 170 , each may be controlled also by manual mechanisms . the fig1 embodiment allows replacement fluid to be prepared in batch for later use . thus , the rate of filtration of replacement fluid need not match the requirements of the treatment process or preparatory steps such as priming . as a result , a low capacity filter may be used for the filter 160 . for example , typically only a small quantity of expensive media is required to make a small - capacity filter and as such , the cost of a low capacity filter can be much smaller than a high capacity filter . also , other features found in high capacity filters , such as a large ratio of media surface to volume of the filter module are achievable only by means of folding or forming media into shapes that can be difficult to manufacture , such as tubes . thus , savings can be achieved in simplification of the configuration of the filter as well . relatively small filters with simple planar media held in plastic casings are available and suitable for this purpose . the configuration of fig1 may be retrofitted for use with an existing treatment system . for this purpose , the outlet 148 may be provided with any required connection adapter . a user interface 175 for entering data into the controller 170 may be provided as well . referring now also to fig2 , a control algorithm for controlling the heater 185 , pump 190 , valves 165 / 180 , etc . begins with the a setting of a time for treatment s 10 , for example by entering a time into the controller 170 via a user interface ( ui ) 175 . the time can be entered manually or automatically by means of , for example , a data signal from a remote source via a switched or network circuit . the time for treatment may be obtained from a treatment calendar entered into the controller 170 , which also may be obtained from a remote source . in the present simple algorithm , first and second time intervals t 1 and t 2 are defined representing the interval required for filtration of rf and the interval required for heating of rf , respectively . these values may be obtained from any of the above means ( e . g ., local manual or remote entry via ui / interface 175 ) or from data encoded on one of the consumables involved in the process . for example , the filter 160 , the rf fluid container 147 , the source fluid 150 container ( s ), or any other consumable may be provided with one or more bar - codes , rfid tags , or other suitable encoding device . such devices may provide values for t 1 and t 2 , tables of values that depend upon other factors , or other data from which t 1 and t 2 may be derived . the controller 170 waits until it is time to start the flow of raw rf fluid from source fluid 150 toward container 147 by comparing a current time ( indicated by a clock internal to the controller 170 , which is not shown ) to a difference between a scheduled treatment time and t 1 , which represents the lead time ( ahead of the scheduled treatment ) required for the filtering process . a loop through step s 20 is exited to step s 30 when the clock reaches the treatment time minus t 1 . at step s 30 , the flow of source fluid 150 through the filter 160 is initiated . if the pump 190 is present , it may be started and regulated according to a specified tmp . the latter may be provided to the controller 170 manually or automatically through ui / interface 175 . automatic entry may be by way of a data store such as bar - code or rfid attached to the filter , for example which may be read when the filter 160 is installed in a chassis with a corresponding reader device ( not shown ). note , as mentioned above , the source fluid may be sterile and the filtration process provided as a guarantee against contamination , for example by accidental touching . once the flow of source fluid 150 is initiated , the controller waits for the required time for applying power to the heater 185 . the delay and the initiation are controlled by step s 40 which is exited to step s 50 only when the treatment time minus the predefined interval t 2 is reached . note that the delay may also be zero . as mentioned above , alternatively , the heater may be triggered by detecting fluid such as by means of a sensor 186 of fig1 ( not shown ) triggered by the presence of filtered replacement fluid 130 in the container 147 . the sensor 186 may be any of a variety of types , such as an ultrasonic sensor , capacitance sensor , mass sensor , optical sensor , etc . once the heater is started , the controller 170 may wait for the source fluid to be exhausted at step s 60 . step s 60 exits to step s 70 when the source fluid is determined to be exhausted . the latter may be detected by integrating the flow rate to measure the total volume ( the rate may be determined by the pumping rate , for example , or by a flow meter ( not shown )). the exhaustion of the source fluid 150 may also be indicated by a quantity indicator ( e . g ., a level indicator ) in the filtered replacement fluid container 147 or an intermediate container supplied through a drip chamber , for example . alternatively , the exhaustion of the source fluid 150 , if supplied from a fixed - volume container , may be indicated by a sensor such as an ultrasonic sensor , capacitance sensor , mass sensor , optical sensor , a scale , etc . yet another alternative is to sense gas or a precipitous rise in negative pressure ( sensed by a pressure sensor which is not shown ) at the pump 190 inlet . at step s 70 , the line 120 may be clamped by actuating shutoff / control valve 180 . additionally , if appropriate , the pump 190 may be deactivated at the point where the exhaustion of the source fluid 150 is detected at step s 70 . according to an embodiment , as the fluid is pumped , the tmp of the filter , as indicated by pressure sensors 162 , may be monitored . if the tmp is determined by the controller 170 to be , at any point , below a predetermined nominal value or to have changed precipitously during filtration , the controller 170 may trigger an alarm or take some other action to insure that the resulting replacement fluid is handled appropriately . for example , a back - up filter could be added during treatment as discussed with respect to fig5 . the tmp results could trigger an alarm at any point during filtration or could be assessed and reported at step s 70 , before treatment would begin . the controller 170 pauses again at step s 80 to wait for the sterile fluid to be exhausted . this may be indicated by a signal from the treatment machine ( e . g ., received via ui / interface 175 ) or by direct measurement by a sensor , such as an ultrasonic sensor , capacitance sensor , mass sensor , optical sensor , a scale , etc . as mentioned above , the controller 170 , or the heater 185 itself , may be provided with a threshold temperature - rise rate that indicates the mass of fluid in the replacement fluid container 147 has fallen below a minimum level . the loop of step s 80 is exited to step s 90 where power to the heater 185 is terminated . note that all the functionality of the controller 170 may be provided , via a control interface , by a controller ( not shown ) internal to a treatment machine . for example , the apparatus of fig1 could be provided as an optional module for such a treatment machine rather than a retrofit module . referring now to fig3 , a combination blood treatment system and filtered replacement fluid device 310 has a replacement fluid preparation subsystem 305 configured substantially as the device of fig1 . a filter 260 filters fluid from a source of fluid 250 to generate a batch of filtered replacement fluid 230 as in the embodiment of fig1 . again , the source of fluid 150 may be a container of purified or unpurified replacement fluid , one or more containers of constituents which , when combined , form a proper replacement fluid and any of the latter may include a continuous source such as a water tap . a line 320 conveys the source fluid 250 through the filter 260 and into a batch container 247 , which may be any type of sterile , preferably disposable container , for example , a large iv bag . it may also include a number of such containers appropriately interconnected to permit flow into and out of them in the fashion of container 247 . again , a pump 290 may be provided and pressure at an outlet of the filter 260 may be sensed by a pressure sensor 262 . the pump 290 may be controlled by a controller 270 to insure a maximum safe tmp to maximize throughput . again , the pump 290 is not required and the source fluid 250 may be arranged such as to maintain a desired tmp at the filter 260 without the need of the pump 290 or pressure sensor 262 by elevation . a control valve 265 or a speed of the pump 290 may be used to regulate the flow rate to maintain desired tmp limits . a control / shutoff valve 280 may provide the controller 270 the ability to stop the flow of fluid through the filter 260 once a desired volume is reached . a heater 285 may be provided to warm the filtered replacement fluid 230 to prepare it for use . an insulated container 245 may be used and the heater controlled using a temperature sensor 283 as discussed with respect to the fig1 embodiment . bubbles may be controlled , as discussed above , by means of a vibration or ultrasonic transducer 284 and remaining fluid by means of pressure sensor 286 . a connector 295 may be provided for connecting the source fluid to the line 320 . the connector may be a luer , spike , threaded adapter , or any other suitable type . although the various controls indicated above are shown to be controlled an automatic controller 270 , each may be controlled also by manual mechanisms . other aspects of the control mechanisms for the embodiment of fig3 may be provided as discussed with respect to fig1 and 2 . the benefits of the fig3 embodiment are similar to those of the fig1 embodiment in that it allows replacement fluid over a time period that is not driven by the speed of supply to the treatment process . as a result , a low capacity filter may be used for the filter 260 with the attendant benefits identified above . note that the ui / interface 275 and controller 270 are shared in the present embodiment by the treatment machine . thus , any information required for control of both the treatment and preparation of filtered replacement fluid 230 would not need to be communicated to a separate controller such as controller 270 . note also that the communications among the illustrated components is provided by a channel 202 which may be wire harness , separate wires , a bus , a wireless channel or any suitable communications / power transmission device . in the embodiment of fig3 , a predicted quantity of replacement fluid may be filtered and stored for use during treatment . if , however , for some reason , more is required , the treatment machine controller 270 could be configured to identify that situation and control the subsystem 305 components to provide it . many blood treatment process employ a filter 220 to filter blood and into which replacement fluid is supplied to a patient 225 . more details on preferred embodiments of the treatment machine are discussed below . in either of the above embodiments , the rate of flow of fluid during preparation of the batch of replacement fluid may be substantially less than the rate of consumption during treatment . in an exemplary embodiment of an application for hemofiltration , the amount of replacement fluid consumed is between 9 and 18 l . and the rate of consumption is approximately 200 ml ./ min . for daily treatment , a higher quantity of fluid is required . also , the media used for sterile filtration may be any suitable media that insures the quality of the replacement fluid is as desired . in the embodiments discussed above , it was assumed that the end sought was preparation of filtered replacement fluid employed microfiltration to prevent the passage of pyrogens including endotoxins and any other pyrogens . however , the invention could be used with other types of filtration or treatment processes to produce a batch of fluid consumed by a medical treatment process , for example , dialysate for hemodialysis treatment . the benefits accrue in particular when the time scale of preparation may be longer than the time scale of consumption . moreover , the benefits are more appreciable when some sort of energy - consuming process is required , such as heating , before consumption . here , not only is the time scale of preparation compatible with a small inexpensive filter , but the long time scale permits heating of the replacement fluid over a long interval . to support this benefit , the batch container may be insulated to minimize heat loss so a small heater will be adequate . also , the preferred application for the present invention is in the context of hemofiltration because the quantity of fluid required for such treatment is relatively small . note that other motivations for filtering the fluid , in addition to or as an alternative to sterilization of a non - sterile fluid , is ( 1 ) removal of air bubbles and / or ( 2 ) as a safety net for ensuring against accidental contamination . if bubble removal is the only concern , a drip chamber may be used instead of a filter . for removing bubbles , the filter preferably is of a type that permits the passage of fluid , but which blocks the passage of bubbles , for example due to its media pore size and the surface tension of the fluid . referring now to fig4 a , a preferred type of filter 400 for some of the present embodiments has an inlet port 415 providing an inlet channel 410 communicating with an inlet chamber 440 . an outlet leading port 405 provides an outlet channel 420 communicating with an outlet chamber 445 . a piece of filter media 425 separates the inlet and outlet chambers 440 and 445 . the fluid to be sterilized enters the inlet chamber 440 , is sterilized by passing through the filter media 425 , and exits via the outlet chamber 445 . a gas relief gasket 428 allows gas accumulating in the inlet chamber 440 to be released to the ambient atmosphere . internal supports and structural details are not shown in the illustration for clarity , but a practical embodiment of the filter of fig4 may have ribs for strength and internal supports for the media 425 and gasket 428 so that the filter 400 may be capable of tolerating a substantial tmp . an integrated contact sensor 412 may be incorporated in the filter to sense the quality of the fluid such as its salinity . the illustration shows a pair of conductive contacts which , as will be understood by those of skill in the art , may be connected to a conductivity measuring device to generate a signal . note that the sensor 412 could also include a non - contact type sensor such as an induction type device . the gas relief gasket 428 may be of a porous hydrophobic material such as ptfe . air bubbles trapped in the inlet chamber 440 can coalesce in the inlet chamber 440 and exit via the gas relief gasket 428 . it may be , depending on the type of gas relief gasket 428 used , that a substantial tmp will be required to eliminate air . an alternative to the gas relief gasket 428 is a gas relief valve 426 as shown in fig4 b . since the inlet chamber 440 is connected to the non - sterile side of the filtration system , there is little risk of contamination if microbes were to enter through a mechanical device such as the gas relief valve 426 . the latter is illustrated figuratively and allows only gas to escape . other features of the embodiment of fig4 b are labeled with the same numerals as features of the embodiment of fig4 a where they serve substantially identical functions and , thus , their descriptions are not repeated here . referring now to fig5 , the filters of fig4 a and 4b may be used for filtration of replacement fluid in the embodiment of fig5 as discussed presently . replacement fluid 360 , which may or may not be sterile , is supplied to a hemofiltration machine 490 . a replacement fluid pump 350 pumps the replacement fluid into a balancing mechanism 330 which meters the replacement fluid before it is introduced , via a junction 485 , into the venous ( return ) line 480 and ultimately into the blood stream of a patient 225 . note that a common alternative configuration dilutes the arterial blood at 480 b before it enters the filter 395 . waste fluid is drawn through a waste line 470 from a filter 395 and pumped via a waste pump 365 through the fluid balancing mechanism 330 . the fluid balancing mechanism 330 meters the replacement fluid to match the rate of withdrawal of waste fluid so that the patient &# 39 ; s fluid balance is maintained during treatment . actually , the rate of withdrawal of waste fluid may be greater than the rate of metering of replacement fluid by pumping waste fluid through a bypass pump called an ultrafiltration pump 339 . the latter sends some of the waste fluid directly to a waste fluid sump 380 , thereby bypassing the fluid balancing mechanism 330 . the fluid balancing mechanism is depicted figuratively and may operate in accord with any suitable control device . preferably it meters replacement fluid on an equal - volume or equal - mass basis . a preferred mechanism is described in u . s . patent application ser . no . 09 / 513 , 911 , filed on feb . 25 , 2000 , entitled : “ synchronized volumetric fluid balancing systems and methods ,” which is hereby incorporated by reference as if fully set forth in its entirety herein . various sensors and line clamps , indicated figuratively at 335 , 355 , 320 , 385 , and 390 , may be provided to control flow and ensure safe operation . a filter 337 is provided in the replacement fluid line 338 just upstream of the junction 485 . the filter 337 may serve as a last chance safety net for ensuring that replacement fluid is sterile and / or that all bubbles are removed before flowing into the venous line 480 . to ensure that air is not infused into the patient &# 39 ; s body , an air sensor 390 is often provided in hemofiltration systems , but detection of air normally triggers an alarm , automatic shutdown , and skilled intervention to restart the hemofiltration treatment . obviously , this is undesirable so the system should , as effectively as possible , insure that air or other gas is not injected into the venous line 480 without requiring interruption . although the embodiment of fig5 includes a hemofiltration machine , other types of treatment processes may be provided a last - chance filter similar to filter 337 and air sensor 390 . for example , hemodiafiltration , hemodialysis , or other treatments may require the infusion of replacement fluid and thereby benefit from a filter such as filter 337 . preferably , the filter 337 is substantially as in the embodiment of fig4 a . thus , the filter 337 removes both air and pyrogens . instead of employing a filter at the location indicated at 337 , a drip chamber may be used . suitable drip chambers are currently available with air vents and microfilters effective to remove pyrogens , so they may be substituted for the filter 337 . also , in some cases , it may be that there is very little risk that the replacement fluid is contaminated with pyrogens , the filter 337 may serve as a mechanism for removing only air or other gases . in such cases , drip chambers which remove gas ( either with or without a vent ), could be employed at the above location in the fluid circuit . referring now to fig6 , 7 , and 8 the last chance filter or drip chamber ( or combination device ) 510 may be installed in a cartridge 520 that holds and orients blood and fluid circuits for a hemofiltration machine 540 . in the embodiment shown , which is described substantially in u . s . patent application ser . no . 09 / 513 , 773 , filed feb . 25 , 2000 and entitled : “ fluid processing systems and methods using extracorporeal fluid flow panels oriented within a cartridge ,” hereby incorporated by reference in its entirety as if fully set forth herein , fluid circuit components may be held in a cartridge 520 and clamped ( as shown in fig8 with the machine closing as illustrated by the arrow 665 ) within a receiving gap 530 in a blood treatment machine such as hemofiltration machine 540 . the cartridge 520 may have a preferred orientation which may insure a correct orientation for the last chance filter or drip chamber ( or combination device ) 510 if required by the particular device chosen . to insure orientation of the last chance filter or drip chamber ( or combination device ) 510 , the latter is preferably held by the cartridge 520 in a fixed orientation with respect to the cartridge 520 . in an alternative embodiment , the last chance filter or drip chamber ( or combination device ) 520 may be accompanied by a device 660 for measuring the quality of the replacement fluid , such as conductivity or density . this may provide a last - chance check that the replacement fluid is of the correct type . for example , where such fluids are derived from mixtures , if the proportion is not exactly what is required , infusion could be harmful to the patient 225 . an example of a device 660 to test the fluid could be a wettable pair of contacts ( not shown ) formed in a tubing set 650 of the cartridge may be used in conjunction with a resistance measurement device to measure the ion concentration of the fluid . alternatively , a non - wettable sensor , such as an inductive conductivity cell could be used . other kinds of fluid quality sensors could be employed such as specific - molecule detectors built on silicon wafers and temperature sensors . preferably , the tubing set 650 and cartridge 620 of which it is a part form a disposable component that is used for one treatment and disposed of . note that the fluid quality sensor 660 may used alone or together with the last chance filter or drip chamber ( or combination device ) 510 . note , although fig6 and 7 are detailed , they are intended to show various components figuratively and do not reveal the details of the routing necessary to achieve the flow paths discussed with respect to them or as illustrated elsewhere . referring now also to fig9 , the tubing set and cartridge assembly 610 , discussed previously , may incorporate the batch replacement fluid container 625 as part of a sterile replaceable set 690 . the filter 615 may have a tube 622 with a connector 620 for attachment to a source fluid 250 . a tube 635 may connect the filter to the batch replacement fluid container 625 , which may be fitted with another tube 630 connected by a connector 648 , which may be permanent or removable , to convey fluid to the tubing set and cartridge assembly 610 . referring now also to fig1 , the batch replacement fluid container 625 may also be fitted with additional connectors 670 and / or extensions ( not shown ) to permit the batch replacement fluid container to be used for priming blood , replacement fluid , and / or waste lines . for example , as discussed in u . s . patent application ser . no . 09 / 905 , 246 , filed jul . 12 , 2001 , entitled : “ devices and methods for sterile filtering of dialysate ,” which is hereby incorporated by reference as if fully set forth in its entirety herein , replacement fluid is circulated through a replacement fluid container 740 to flush air out of all the fluid circuiting ( not all shown ) of a blood treatment apparatus 710 . as described in detail in the &# 39 ; 246 application incorporated by reference above , the venous ( return ) and arterial ( supply ) blood lines 725 and 730 may be temporarily connected via connectors 750 to the replacement fluid container 740 and fluid circulated through the container 740 until gas bubbles are substantially purged from the corresponding circuits . note , the replacement fluid container 740 corresponds to the containers 147 ( fig1 ), 247 ( fig3 ), and 625 ( fig9 ) in the foregoing figures and to respective containers in the application incorporated by reference immediately above . the air and other gases may settle in the replacement fluid container 740 as the fluid circulates . liberation of the gases would ordinarily be promoted by the application of heat from a heater 775 ( with power source 770 ), which may be employed as discussed with regard to the embodiments of fig1 - 3 or in any suitable way to bring the temperature of the replacement fluid to body temperature . replacement fluid circuits including line 735 , blood circuits including lines 725 and 730 , and waste fluid circuits including line 780 may all be flushed with fluid from the container 740 . the details of the blood treatment apparatus and its internal plumbing can vary . replacement fluid may be transferred from the replacement fluid line 735 or from the blood line 735 to the waste line , for example through a filter , to flush the waste portion of the circuit including the waste line 780 . replacement fluid may circulate through the blood circuit including lines 725 and 730 as indicated to flush the blood circuit , at least a portion of which may be closed as indicated by the arterial and venous lines 730 and 735 . disposable components , such as the circuit sets of fig8 and 9 or the batch replacement fluid container 625 alone , or other components that may be used with the embodiments disclosed may be packaged with instructions for preparing infusible replacement fluid . for example , the source fluid 150 / 250 or a concentrate which may be mixed to make the same ( fig1 and 3 ) may be supplied with instructions for sterile filtering the fluid as described in the instant specification . such may constitute packages of consumables or reusable components . note that benefits of the filtering method and apparatus discussed above may best be achieved by performing the filtration just prior to treatment , although this is not required . the filtering method may be performed at the treatment site . for example , non - sterile concentrate may be stored at the residence of a patient . the concentrate may be diluted with distilled water in a source fluid container ( e . g ., 196 of fig1 ) at the residence and processed as discussed in the instant application . because the infusible fluid is generated at the treatment site , the need for regulatory - cleared fluids , such as might be obtained from a manufacturer , is not avoided . cost savings and storage - space economies can thus be realized by the patient . this is particularly important in view of the fact that renal replacement therapies are often administered many times per week and storage and cost of consumables can present a serious problem in a residence or any other facility . referring now to fig1 , a blood treatment machine , a portion of which is illustrated figuratively at 810 , may permit a pump 845 that , during treatment , conveys replacement fluid to a patient , to be used for sterile filtering a non - sterile source fluid . here , the machine 810 has a common guide 850 that accommodates a fluid line 815 through which fluid is conveyed by the pump 845 , for example a peristaltic pump . during treatment , the line 815 - 825 may be guided by a first selected guide 830 in a first direction toward other components of an internal fluid circuit ( not shown ) as indicated at 825 . during sterile - filtering , fluid may be pumped by the same pump 845 through a line 815 - 820 that is allowed to pass out of the blood treatment machine 810 via a different guide 835 . this allows the line 815 - 820 to be fed to an external connection to the sterile fluid container ( not shown ) as indicated at 820 . referring now to fig1 - 14 , a patient 640 receives a blood treatment by a continuous process performed by a blood treatment machine 610 . the process extracts fluid from the blood of the patient 640 which must be replaced to prevent the patient 640 from dehydrating . for example , the treatment process may be hemofiltration or hemodiafiltration . in such processes , blood may be drawn from the patient 640 through an access 650 and returned to the patient 640 through the same access 650 . as is known in the art , the treatment process provided by the blood treatment machine 610 may remove substantial quantities of fluids including electrolytes from the patient &# 39 ; s 640 blood . as part of the process , as is also known , fluid may be provided to the patient 640 during treatment . during hemofiltration , for example , multiple liters of fluid may be required to replace what is withdrawn from the patient during treatment . such fluid may require multiple standard containers 10 - 30 to make up a sufficient quantity to treat the patient 640 . the desired low levels of endotoxins discussed above may be provided by means of a manifold 683 having inline filters 681 on each arm 665 of the manifold 683 . the manifold 683 has a header 655 connecting each arm 665 to a common feed line 645 . referring to fig1 and 14 , filters may be located on each arm 740 of a manifold 770 as indicated at 776 or on a common feed line 790 as indicated at 779 . either embodiment may include spikes 778 or other suitable connectors for connecting to the source containers 10 - 30 . again , the filters 681 , 776 , and 779 are preferably configured to ensure levels of endotoxins in the filtered product are lower than 5 eu / kg ./ hr . of treatment time and no more than 0 . 03 eu / ml . although the foregoing invention has been described by way of illustration and example , it will be obvious that certain changes and modifications may be practiced that will still fall within the scope of the appended claims . for example , the devices and methods of each embodiment can be combined with or used in any of the other embodiments .

US-4074808-A

guidewire exit ramp members that may be placed over a tubular member having a guidewire lumen , which longitudinally extending and laterally accessible , and methods of use . the guidewire exit ramp member can be placed to force a guidewire loaded through the lumen in a first direction to be forced out of the lumen via an opening , slit or channel . the guidewire exit ramp member , in an illustrative embodiment , takes the form of a relatively short member having a proximal portion and a distally extending flap . the flap may be designed to enter and remain in a longitudinally accessible guidewire lumen . combinations of such ramp members and device shafts having longitudinally extending laterally accessible guidewire lumens are also disclosed , as are methods for securing such combinations together . a method of backloading a guidewire into a catheter while causing lateral exit of the guidewire at a desired location is also shown .

the following detailed description should be read with reference to the drawings . the drawings , which are not necessarily to scale , depict illustrative embodiments and are not intended to limit the scope of the invention . fig1 a is a partial elevational view of a medical device shaft having a longitudinally extending laterally accessible guidewire lumen . the shaft 10 includes a channel 12 for laterally accessing a guidewire lumen passing therethrough . fig1 b is a cross - sectional view along line 1 b - 1 b of fig1 a . as illustrated by fig1 b , the guidewire lumen 14 includes the channel 12 . two auxiliary lumens 16 , 18 are also illustrated . while a triple lumen shaft 10 is illustrated , any number of lumens , from a single lumen up to 3 , 4 , or more lumens , may be provided in a shaft for use with the present invention . the channel 12 is illustrated for providing access to a generally u - shaped guidewire lumen . instead of a u - shape , a c - shaped opening may be provided , the c - shape helping to retain a guidewire in the lumen 14 . additionally , a slit may be used . alternatively , instead of an channel 12 creating an opening , a wall for the lumen 14 where the channel is shown may be thin or intentionally thinned to enable a guidewire to be torn therethrough . perforations may also be provided to make the longitudinally extending guidewire lumen 14 laterally accessible . laterally accessible , as used herein , refers to a guidewire lumen that can be accessed along a length thereof , where access can be had either through an existing opening or by tearing a guidewire disposed in the guidewire lumen laterally through a slit , thin , thinned , perforated , or otherwise relatively weak lumen wall section . fig2 is a plan view of a cannula including a longitudinally extending laterally accessible guidewire lumen . the cannula 20 may incorporate a shaft 10 as illustrated in fig1 a and 1b having a distal end 22 and a proximal end 24 . a slit 26 extends along a length of the shaft toward the distal end 22 ; while not shown , the slit 26 may extend proximally to a guidewire entry adaptor 28 . the example also illustrates marker bands near the distal end . proximal of the adaptor 28 is a manifold 30 including two fluid infusion ports . the cannula in fig2 may have a similar cross section to that shown in fig1 b , except to the extent that a slit 26 is used instead of a u - shaped opening . the fluid infusion ports on the manifold 30 may be coupled to the auxiliary lumens of the cannula shaft for infusing fluids to a location at or near the distal end 22 . the adaptor 28 shown functions by having a side - directed ramp / lumen with an opening allowing for lateral removal of a guidewire therefrom . the proximal end of the guidewire is controlled proximal of the adaptor 28 such that there is no need to force a backloaded guidewire from the guidewire lumen . the guidewire can be removed through the slit 26 once the exchange procedure starts . however , the exact location where the guidewire exits the slit 26 is not controlled . in particular , if a guidewire is backloaded into such a rapid exchange catheter , the adaptor 28 does not force the guidewire out of the catheter . an example and description of such an adaptor 28 is given by windheuser et al ., in u . s . pat . no . 6 , 606 , 515 , the disclosure of which is incorporated herein by reference . the adaptor 28 has a relatively large profile in order to achieve ease of guidewire entry through a funnel - shaped portion , as further discussed by windheuser et al ., and is designed to prevent passage of the entire adaptor through a side port in an endoscope . such sizing would also typically prevent passage through a guide catheter used in a vascular procedure . during a catheter exchange procedure , with the guidewire already in place at a desired location in the patient ( i . e ., a vascular location , a location in the biliary tract , or any other cannulated location ), the guidewire will extend through the guidewire lumen from the adaptor 28 to the distal end 22 . to exchange the cannula 20 , the guidewire is moved laterally out of the adaptor 28 and held in place as the cannula 20 is withdrawn . as the cannula 20 is withdrawn , the guidewire passes through the slit 26 , remaining in its internal location in the patient without requiring a guidewire extension . the slit 26 may extend to the distal end 22 , or may stop proximal of the distal end . fig3 is a perspective view of a guidewire exit ramp member for use in conjunction with a medical device shaft having a longitudinally extending laterally accessible guidewire lumen . the illustrative example guidewire exit ramp member includes a proximal portion 50 , a flap 52 , and a distal section 54 . the proximal portion 50 surrounds and / or tracks over an elongate medical device on which the guidewire exit ramp member is used . the shape is shown as cylindrical but may instead be oval , polygonal , or other shapes including polygons with one or more curved sides . in other illustrative examples , the proximal portion 50 may only partly surround an elongate medical device , and may instead take the form of a partial cylinder , or may have one or more gaps . in several embodiments , the form illustrated in fig3 is used for its low profile , allowing the guidewire exit ramp member to be readily placed and used even in situations where low profile is a concern . fig4 is an elevation view of the illustrative guidewire exit ramp member of fig3 showing the flap 52 more clearly . as can be seen , the example flap 52 has rather angular distal ends , extending distally relative to , but shorter than , the distal section 54 . in other embodiments the flap 52 may be longer than the distal section 54 , and , in one embodiment , the distal section 54 may be entirely omitted . for some embodiments , the flap 52 will be inserted through a transversely cut opening in an elongate medical device , as further explained below . for such embodiments , the inclusion of the distal section 54 may help maintain the shape , pushability , and / or anti - kinking characteristics of the elongate medical device across the transverse cut since the transverse cut may weaken the elongate medical device . fig5 is a side view of the illustrative guidewire exit ramp member of fig3 . the distal portion 54 has a reduced profile due to the flap 52 . fig6 is an end view of the illustrative guidewire exit ramp member of fig3 . the flap 52 is shown extending down into the lumen defined by the distal portion 54 , which is in line with the lumen formed in the proximal portion 50 . in an illustrative embodiment , the flap 52 is biased to bend down as illustrated by fig3 and 5 - 6 . in one embodiment , the guidewire exit ramp member shown in fig3 - 6 is formed by a molding process . in other embodiments , the guidewire exit ramp member may be formed by cutting a tubular member . the ramp member may be sized to correspond to a given size of elongate medical device shaft . for example , given a 6 - french elongate medical device shaft , the inner diameter defined by the proximal portion of the ramp member may be just large enough to slide over such a device shaft . the inner surface of the ramp member may include a lubricious coating to allow easy movement and placement over the device shaft . alternatively , the material chosen for making the ramp member may be chosen for its lubricious properties . the ramp member may be formed of a wide variety of materials . in some embodiments the ramp member is formed of a nylon material , which is inexpensive and easy to mold , as well as being a popular material for medical applications . polycarbonate may also be used , as well as any of a wide variety of polymers , copolymers and metals or alloys known for use in medical devices , catheters , cannulas , endoscopes , and the like . any other suitable biocompatible material may also be used and / or incorporated . fig7 is an elevation view of an alternative example guidewire exit ramp member with a curved flap . as illustrated , the guidewire exit ramp member includes a proximal portion 60 , a flap 62 , and a ( optional ) distal portion 64 . as shown at 66 , the flap 62 has curved ends , which may allow the flap 62 to extend into and generally match the contours of a guidewire lumen having curved interior contours . rather than a simple curve as shown , the flap 62 may be designed to match a particular guidewire lumen shape / cross section . fig8 a is an elevation view of an illustrative guidewire exit ramp coupled with a medical device shaft having a longitudinally extending laterally accessible guidewire lumen . a device shaft 100 is shown with a guidewire exit ramp member 102 placed thereover . the ramp member 102 includes a flap 104 that is aligned with and enters a channel 106 ( shown as a u - shaped channel for the purposes of illustration ). the longitudinal cross section of fig8 b illustrates that the ramp member 102 has a proximal portion that surrounds the device shaft 100 , with the flap 104 extending down into the channel 106 . the transverse section views of fig9 a - 9c illustrate that the device shaft 100 is shown having the channel 106 as well as auxiliary lumens 108 and 110 . as shown in fig9 b , along line 9 b - 9 b in fig8 a , the flap 104 extends partly into the channel 106 , with the optional distal portion of the ramp member 102 extending around the device shaft 100 at that location . fig9 c is taken at a more distal location along the device shaft 100 and ramp member 102 , as shown by line 9 c - 9 c of fig8 a . by this point , the flap 104 extends down to the base of the channel 106 . if a guidewire is backloaded into the channel 106 , the flap 104 will force the guidewire out of the channel 106 . however , if a guidewire is passed distally from a more proximal location , as can be seen in fig8 b , the slant of the flap 104 will allow the flap 104 to deflect so that the guidewire may pass with little resistance generated by the flap 104 . fig1 a - 10c , 11 a - 11 c , and 12 a - 12 c illustrate placement of a guidewire exit ramp on another medical device shaft having a closed longitudinally extending laterally accessible guidewire lumen . referring to fig1 a - 10c , a guidewire exit ramp member 200 having a flap 202 is shown placed on a device shaft 204 , the device shaft 204 having an opening shown as skive 206 . the ramp member 200 is shown some distance proximal of the skive 206 on the device shaft 204 . as highlighted in fig1 b , ( a section view along line 10 b - 10 b of fig1 a ) the device shaft 204 includes a guidewire lumen 208 having a thinned wall 210 , as well as an additional auxiliary lumen 212 . the thinned wall 210 enables a guidewire to laterally exit the guidewire lumen 208 by tearing through the thinned wall 210 . to further weaken the wall , perforations may be provided . the thinned wall 210 may be provided during extrusion or by post - extrusion machining . the longitudinal cross section of fig1 c illustrates the skive opening into the guidewire lumen 208 . turning to fig1 a - 11c , fig1 a shows that the ramp member 200 has been advanced such that the flap 202 partly enters the skive 206 in the device shaft 204 . fig1 b shows in transverse cross section that the flap 202 reaches partly down into the guidewire lumen 208 through the skive 206 . as shown by fig1 c , the skive 206 enables easy entry of the flap 202 down into the guidewire lumen 208 through the thin wall 210 . in some embodiments , the flap 202 may be biased downward such that it readily extends through the skive 206 . it should be noted that the thinned wall 210 would not be necessary to use the guidewire ramp member 200 in the fashion shown , since the flap 202 simply enters through an opening into the guidewire lumen 208 . referring now to fig1 a - 12c , the ramp member 200 is moved distally along the device shaft 204 until the flap 202 completely enters the guidewire lumen 208 through the skive 206 . once this location is reached , the flap 202 may rest against an interior wall of the guidewire lumen 208 . when so located , a guidewire proximal end passing in a proximal direction through the guidewire lumen 208 may be forced laterally out of the device shaft 204 by the flap 202 . thus backloading of a guidewire into the device shaft 204 can be performed easily with an assurance that a guidewire will exit the device shaft 204 at a desired location defined by the skive 206 and the ramp member 200 . in various illustrative embodiments , the ramp member 200 may be moveable with respect to the shaft or secured ( by adhesive or welding , for example ) to the device shaft 204 once placed as shown in fig1 a . fig1 a - 13c illustrate in elevation and section views of an alternative embodiment making use of a pinch or squeeze type of ramp . as can be seen , the ramp member 300 includes a proximal portion 302 and a pinching portion 304 . the pinching portion 304 may be sized to reduce the internal diameter or cross - sectional area of the ramp member sufficient to collapse a portion of a guidewire lumen . in one embodiment , the reduced diameter / area is sized to prevent pinching of any auxiliary lumens of an associated medical device , though some compression may be acceptable . it should be noted that the pinching portion need not be cylindrical and may take on a variety of shapes adapted for use with various catheter shafts . as shown in fig1 c , the transverse section of the pinching portion 304 is shaped to receive a catheter shaft without pinching any auxiliary lumens , instead being shaped to compress only the guidewire lumen . the dashed lines of fig1 c represent , in phantom , the locations of a guidewire lumen and two auxiliary lumens for a catheter shaft received and pinched by the ramp member 300 . it can be seen that two of the lumens ( the auxiliary lumens ) would not be significantly blocked . fig1 a - 14c illustrate placement of the embodiment of fig1 a - 13b on an elongate medical device shaft . as shown in fig1 a , the elongate medical device shaft 310 is provided with a transverse cut 312 that may take the form of a skive or slit . if desired , the shaft 310 may include a guidewire lumen having a thinned or weakened wall . as shown in fig1 b , the ramp member 300 is slid onto the shaft 310 until the ramp member 300 engages the transverse cut 312 . at the location of the transverse cut 312 , the shaft 310 will be inherently weaker due to the transverse cut 312 across a portion of the wall of the guidewire lumen . turning to fig1 c , it can be seen that the ramp 304 of the ramp member 300 collapses a portion of the wall of the guidewire lumen 314 , but the auxiliary lumen 316 is not significantly affected . the proximal portion 302 aids in letting the ramp 306 collapse the wall of the guidewire lumen 314 . a guidewire backloaded into the shaft 310 will now be forced out of the guidewire lumen 314 at the ramp 304 . any suitable plastics may be used for the shaft 310 and the ramp member 300 . for the alternative embodiments of fig1 a - 13b and 14 a - 14 c , the ramp member 300 may be formed of a stiffer material than the material used to define the guidewire lumen 314 . to preserve the patency of the auxiliary lumen 316 , some embodiments may make use of a reinforcing member to support the auxiliary lumen 316 . those skilled in the art will recognize that the present invention may be manifested in a variety of forms other than the specific embodiments described and contemplated herein . accordingly , departures in form and detail may be made without departing from the scope and spirit of the present invention as described in the appended claims .

US-91797404-A

creatine derivatives and compositions containing a bioactive form of creatine . the new chemical entity comprises an acetyl creatine , n - acyl creatines , n , n - diacyl creatines or any n - acetyl creatine species with enhanced solubility and bioavailability . also provided by this invention are various methods for providing several beneficial effects that comprise administering compositions comprising n - acetyl creatine , n - acyl creatines , n , n - diacyl creatines or any n - acetyl creatine species to a mammalian subject , either chronically or acutely .

before explaining at least one embodiment of the invention in detail , it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings . the invention is capable of other embodiments and of being practiced and carried out in various ways . also , it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting . this invention relates more specifically to n - acetyl creatine , wherein an acetyl group replaces an active hydrogen of the amino group in creatine and to creatyl peptides wherein an amino acid is chemically attached to the acetylated creatine molecule . it further relates to n - acyl creatines , wherein an acyl attachment replaces an active hydrogen in the amino group in creatine and to creatyl peptides , herein acyl group refers to carboxylic acid , including saturated , monounsaturated , polyunsaturated fatty acid , for example : propionoic acid , docosahexaenoic acid ( dha ), or eicosapentaenoic acid ( epa ). in addition , it relates to n , n - diacyl creatines , wherein two acyl group are attached to two amino groups in creatine and creatyl peptides . this invention further relates to n - acetyl creatine , n - acyl creatines , n , n - diacyl creatine , n - acetyl creatine aliphatic esters and to n - acetyl creatine amino acid dipeptides and their aliphatic esters , which are more bioavailable to mammals than other creatine derivative . as used herein , a “ n - acetyl - creatine species ” may refer to any of n - acetyl creatine , n - acyl creatines , n , n - diacyl creatine , n - acetyl creatine aliphatic esters and to n - acetyl creatine amino acid dipeptides and their aliphatic esters , including creatyl - l - leucine , creatyl - l - isoeucine , creatyl - leucine - l - leucine , creatyl - l - leucine - l - isoleucine singly or in combination . as used herein , “ nucleotide species ” may refer to nucleotides , oligonucleotides , as well as the monophosphate , diphosphate , triphosphate and cyclic derivatives of nucleotides . as used herein , “ peptides ” may refer to amino acids , peptides , di -, tri - and oligo peptides and protein derivatives . as used herein , “ protein isolates ” may refer to egg , collagen , plant and / or milk - based proteins , either singly or in combination , acid stable protein isolates , or a combination or blend of protein isolates , concentrates and hydrolyzates and caseins in micellar forms . in accordance with the principles of the invention , a creatine species formed by acetylating creatine may be more soluble than other creatine compounds and more bioavailable than other creatine compounds known in the art , as shown in fig1 and 2 . as may be seen in fig1 and 2 , n - acetyl - leucine exhibits extremely poor solubility in an aqueous medium . in this case of acetylated leucine , the solubility of free leucine is ten times greater than the solubility of n - acetyl - leucine . in contrast , acetylation of creatine results in a massive and significant increase in solubility . n - acetyl creatine may be 30 times more soluble than creatine . acetylated creatine in accordance with the invention , may have increased bioavailable and solubility . creatine derivatives , including n - acetyl - creatine species , may be provided as nutritional supplements in the forms of powder , tablet , capsule , buccal , injectable , topical as a gel , lotion or cream , transdermal patch , and other non - aqueous forms suitable for use by mammals . disclosed is n - acetyl creatine , and creatyl peptides suitable for oral administration to mammalian subjects , including humans . n - acetyl creatine has the structure : the synthesis of n - acetyl creatine is achieved as follows : sarcosine was treated with acetyl protected guanidinylation reagents to afford n - acetyl creatine . the materials described by formulae ( i ), ( ii ), ( iii ), ( iv ), ( v ), and ( vi ) above , and the corresponding text in the descriptions , including any and all of its forms , are n - acetyl creatine species , and are , as such , the subject of the present invention . to prepare a composition according to the principles of this invention , one may add a desired amount of n - acetyl creatine species to a selected group of non - aqueous excipients and sufficient mixing may cause a uniform blend of the n - acetyl creatine to afford a non - aqueous composition . in one embodiment , the total concentration of n - acetyl creatine species in a non - aqueous solution provided hereby may be any amount between about 0 . 1 gram and about 22 grams ( or more ), including all amounts therebetween . according to another embodiment , the total concentration of n - acetyl creatine species in a non - aqueous blend provided hereby may be any amount between about 1 gram and about 10 grams , including all amounts there between . according to another embodiment , the total concentration of n - acetyl creatine species in a non - aqueous composition provided hereby may be any amount between about 1 gram and about 5 grams including amounts therebetween . according to another embodiment , the total concentration of n - acetyl creatine species in a non - aqueous composition provided hereby may be any amount between about 0 . 01 g and about 1 gram including all amounts therebetween . in an alternate embodiment , the n - acetyl creatine species may be added to a natural powder beverage in any amount provided that upon reconstitution an aqueous solution or suspension results . these tables show the solubility of creatine and creatine derivatives compared to n - acetyl creatine in 0 . 1n hydrochloride ( hcl ) at 37 ° c . as may be seen , 1 gram of n - acetyl creatine dissolves faster than other creatine derivatives , except creatine ethyl ester hcl , designated creatine ee hcl —( high creatine conversion ) in fig1 . however , this shorter dissolution time may be deceiving . creatine ethyl ester hcl does not actually dissolve faster in aqueous media . instead , creatine ethyl ester hcl decomposes into creatinine in a matter of 2 to 3 minutes . creatinine is an excretory byproduct produced from the breakdown of creatine phosphate and offers none of the numerous benefits of creatine . in other words , creatine ethyl ester hcl is unstable and its rapid conversion to creatinine makes it ineffective in delivering bioavailable creatine to the body . the dissolution of 1 gram of n - acetyl creatine is faster than the other creatine derivatives shown , and the creatine remains stable in solution , not decomposing as creatine ethyl ester hcl does . the dissolution of 1 gram of n - acetyl creatine in a substantially ph neutral aqueous solution is faster than the other creatine derivatives except for creatine ethyl ester hcl which has the disadvantage of not being chemically stable as discussed above . the solubility of n - acetyl creatine in water is 400 grams / 1 liter . this represents a 30 - fold increase with respect to creatine monohydrate with a solubility of about 13 grams in 1 liter . as may be seen from the tables and fig1 and 2 , leucine is also a compound with very low water solubility . furthermore , not only does creatine portion of the creatyl molecule become significantly more soluble than standard creatine ( creatine monohydrate ), l - leucine also becomes significantly more soluble in the creatyl form as it is seen in the creatyl - l - leucine molecule . thus in one single compound two benefits may be achieved i . e ., enhanced solubility of both creatine and of leucine . creatine and leucine may generally have a greater impact than other amino acids in regard to increasing muscle hypertrophy , muscle strength , muscle repair , muscle energetics , mtor ( more specifically , mtorc1 ) activation , mps ( muscle protein synthesis ), anabolism , and also in myostatin inhibition and reduction , anti - catabolism , preventing mpb ( muscle protein breakdown ) etc . the creatyl - l - leucine species may also possess the uptake benefits of di - peptides . similarly , glutamine also has low solubility and rapidly converts to undesirable glutamic acid when combined with water . likewise creatine converts to creatinine over time when combined with water . both glutamine and creatine can be delivered in a stable and soluble form as the creatyl di - peptide : creatyl - l - glutamine . consequently , creatyl - l - glutamine may provide the benefits of enhanced aqueous stability of both creatine and of glutamine . this may allow creatyl - l - glutamine to be provided in products such as ready - to - drink water - based beverages such as sports drinks and beverages for preventing muscle wasting and improve or stabilize brain health in persons confined to a hospital and in a multitude of different medical applications such use as in iv drips , injectable delivery systems etc . in addition , a composition according to this invention may also include nutritional adjuvant materials including flavoring agents , colorants , viscosity modifiers , preservatives , chelating agents , antioxidants , surface modifiers and other nutritional adjuvant materials . other nutritional adjuvant materials include any substance which is generally recognized as promoting the health or function of a mammalian organism , including humans , or benefiting a composition useful thereof in terms of its efficacy , appearance , stability , consistency , aroma , or viscosity . such substances include other amino acids and their salts , vitamins , minerals , essential fatty acids , enzymes , mono - glycerides , di - glycerides , tri - glyceride ester oils ( including , for example vegetable oils and animal fats ) emulsifiers , hydrolyzed proteins , whey protein , stabilizers , flow modifiers , viscosity improvers , chelating agents , enzymes , and surfactants , whether anionic , cationic or nonionic . the total amount of the one or more nutritional adjuvant materials above present in a composition according to this invention is present in any amount between about 0 . 01 % and about 75 % by weight based on the total weight of said composition , including all percentages and ranges of percentages therebetween . in addition to ingredients classified as adjuvant materials , a composition according to this invention may also comprise one or more natural powder beverages . a natural powder beverage for reconstitution , as used herein , is a beverage suitable for human or animal consumption which contains the pulp , extract or any other constituent of a naturally - occurring fruit , vegetable , or animal product whether from the wild , cultured , cultivated on a farm or otherwise domesticated by man . natural powder beverages include without limitation materials such as dried milk products , dried soy products , dried citrus fruit juices , dried non - citrus fruit juices , and dried vegetable juices , or components of any of the foregoing , wherein said natural beverages are present in any effective amount to impart flavor to the compositions , which may be any amount between about 0 . 1 % and about 99 % by weight based on the total weight of said composition , including all percentages and ranges of percentages there between . in addition to ingredients containing adjuvant materials , a composition according to the principles of the invention may alternately comprise one or more synthetic beverages . a synthetic beverage is any beverage which is not a natural beverage . in general , a composition according to the principles of the invention may be provided by combining and mixing the ingredients selected , including any n - acetyl creatine species and any desired quantity of any one or more other ingredients specified herein . a composition according to the principles of the invention may be made quite palatable by a mammalian subject , including human subjects desiring to administer the n - acetyl creatine species compound orally in a non - aqueous mixture . typical serving sizes may be any serving size in the range of about 1 milligram to about 50 grams , in an aqueous solution that is from about 20 ml to about 2 , 500 ml in volume . the composition of n - acetyl creatine in a non - aqueous media or vehicle according to this invention can be made for re - constitution in which n - acetyl creatine may exceed 50 grams per liter and concentrations at or near the solubility limit are herein provided by contacting excess amounts of the n - acetyl creatine in contact with water or an aqueous solution to provide a solution saturated with n - acetyl creatine . such saturated solutions may then be diluted slightly , to afford a concentrate from which other n - acetyl creatine containing compositions may be conveniently provided . the following are examples that illustrate procedures for practicing the invention . these examples should not be construed as limiting . a powder composition ( for reconstitution ) comprising n - acetyl creatine or any n - acetyl creatine species , said composition comprising a suitable non - aqueous solvent or vehicle , a preservative , a physical stabilizing ingredient , one or more surfactants . the composition may also contain nucleotides , oligonucleotides , the monophosphates , diphosphates , triphosphates and cyclic derivatives of these nucleotides , and amino acids , vitamins and vitamin - like isoprenoids , peptides and one or more additional components selected from the group consisting of : lipids , starches , carbohydrates , polyols , minerals , electrolytes , amino trace elements , colorings , flavors , artificial sweeteners , and anti - oxidants an oral liquid composition for buccal sublingual administration comprising n - acetyl creatine or any n - acetyl creatine species , said composition comprising a suitable non - aqueous solvent or vehicle , a preservative , a physical stabilizing ingredient , one or more surfactants . the composition may also contain nucleotides , oligonucleotides , the monophosphates , diphosphates , triphosphates and cyclic derivatives of these nucleotides , and amino acids , vitamins and vitamin - like isoprenoids , peptides and one or more additional components selected from the group consisting of : lipids , starches , carbohydrates , polyols , minerals , electrolytes , amino trace elements , colorings , flavors , artificial sweeteners , and anti - oxidants . an oral solid composition in the form of a capsule ( liquid capsule ) with a liquid composition as fill material for oral administration of n - acetyl creatine or any n - acetyl creatine species containing from about 1 % to about 5 % of water , said liquid fill material composition comprising a suitable lipophilic solvent or vehicle , a hydrophilic non - aqueous vehicle , from about 1 % to about 5 % of water , a preservative , a physical stabilizing ingredient , one or more surfactants . the composition may also contain nucleotides , oligonucleotides , the monophosphates , diphosphates , triphosphates and cyclic derivatives of these nucleotides , and amino acids , vitamins and vitamin - like isoprenoids , peptides and one or more additional components selected from the group consisting of : lipids , medium and short chain triglycerides , starches , polyols , carbohydrates , minerals , electrolytes , amino trace elements , colorings , and anti - oxidants . a powder composition for oral administration of n - acetyl creatine or any n - acetyl creatine species containing from 1 gram to 100 grams of protein and from 1 gram to 100 grams of carbohydrates per serving comprising n - acetyl creatine or any n - acetyl creatine species . the composition comprising egg , collagen , plant and / or milk - based proteins either singly or in combination in a suitable aqueous solvent or vehicle , a non - aqueous vehicle , a preservative , a physical stabilizing ingredient , one or more surfactants . the composition comprising an acid stable protein isolates , or a combination or blend of protein isolates , concentrates and hydrolyzates and caseins in micellar forms , a suitable aqueous solvent or vehicle , a non - aqueous vehicle , a preservative , a physical stabilizing ingredient , one or more surfactants . the composition may also contain nucleotides , oligonucleotides , the monophosphates , diphosphates , triphosphates and cyclic derivatives of these nucleotides , and amino acids , vitamins and vitamin - like isoprenoids , peptides and one or more additional components selected from the group consisting of : lipids , starches , carbohydrates , polyols , minerals , electrolytes , amino trace elements , colorings , flavors , artificial sweeteners , and anti - oxidants . a lyophilized injectable composition for human consumption said composition being isotonic and sterile in nature comprising n - acetyl creatine or any n - acetyl creatine species , said injectable preparation with a ph of about 3 , being substantially stable at room temperature for short term storage conditions , stable at 104 ° fahrenheit ( 40 celsius degrees ) and stable for longer term at 39 ° fahrenheit ( 4 celsius degrees ) in coolers so that it can be stored under refrigeration conditions . the composition comprising a suitable aqueous solvent , a preservative , and / or a physical stabilizing ingredient . the composition may also contain nucleotides , oligonucleotides , the monophosphates , diphosphates , triphosphates and cyclic derivatives of these nucleotides , and amino acids , peptides , proteins and carbohydrates . an anhydrous gel topical composition for skin application in humans and animals said composition being clear or slightly opaque and having a gel consistency so that it can be spread on skin surface comprising n - acetyl creatine or any n - acetyl creatine species , said gel being substantially stable at room temperature for normal warehouse storage conditions , stable at 104 ° fahrenheit ( 40 celsius degrees ) for shipping in hot weather trucks and / or overseas containers , and stable at 39 ° fahrenheit ( 4 celsius degrees ) in coolers so that it can be stored under refrigeration conditions . the composition comprising a suitable non - aqueous solvent , a preservative , a polymer for imparting consistency and / or a physical stabilizing ingredient . the composition may also contain nucleotides , oligonucleotides , the monophosphates , diphosphates , triphosphates and cyclic derivatives of these nucleotides , and amino acids , vitamins and vitamin - like isoprenoids , peptides , proteins and carbohydrates . a deep - penetrating transdermal composition for application in humans and animals said composition being a non - aqueous solution , a gel - like system or an opacified gel - like system and having a consistency so that it can be spread on skin surface comprising n - acetyl creatine or any n - acetyl creatine species , said transdermal composition being substantially stable at room temperature for normal warehouse storage conditions , stable at 104 ° fahrenheit ( 40 celsius degrees ) for shipping in hot weather trucks and / or overseas containers , and stable at 39 ° fahrenheit ( 4 celsius degrees ) in coolers so that it can be stored under refrigeration conditions . the composition comprising a suitable non - aqueous solvent , one or more penetrating enhancers , a preservative , a physical stabilizing ingredient , one or more surfactants , moisturizers . the composition may also contain nucleotides , oligonucleotides , the monophosphates , diphosphates , triphosphates and cyclic derivatives of these nucleotides , and amino acids , vitamins and vitamin - like isoprenoids , peptides , proteins and carbohydrates . a transdermal patch delivery system comprising of a liner , an adhesive , a backing and a non - aqueous liquid reservoir composition . the non - aqueous liquid reservoir composition being a solution or a suspension comprising n - acetyl creatine or any n - acetyl creatine species , said transdermal patch being substantially stable at room temperature for normal warehouse storage conditions , stable at 104 ° fahrenheit ( 40 celsius degrees ) for shipping in hot weather trucks and / or overseas containers , and stable at 39 ° fahrenheit ( 4 celsius degrees ) in coolers so that it can be stored under refrigeration conditions . the composition comprising a suitable non - aqueous solvent , one or more penetrating enhancers , a preservative , a physical stabilizing ingredient , one or more surfactants . the composition may also contain nucleotides , oligonucleotides , the monophosphates , diphosphates , triphosphates and cyclic derivatives of these nucleotides , and amino acids , vitamins and vitamin - like isoprenoids , peptides , proteins and carbohydrates . a composition as provided herein may be administered chronically . as used herein , “ chronically ” has its normal meaning , which generally means repeated ingestion over a period of several days , several weeks or even several months . “ chronic ” is generally not acute . consideration must be given to the fact that although this invention has been described and disclosed in relation to certain preferred embodiments , obvious equivalent modifications and alterations thereof will become apparent to one of ordinary skill in this art upon reading and understanding this specification and the claims appended hereto . this includes subject matter defined by any combination of any one of the various claims appended hereto with any one or more of the remaining claims , including the incorporation of the features and / or limitations of any dependent claim , singly or in combination with features and / or limitations of any one or more of the other dependent claims , with features and / or limitations of any one or more of the independent claims , with the remaining dependent claims in their original text being read and applied to any independent claims so modified . this also includes combination of the features and / or limitations of one or more of the independent claims with features and / or limitations of another independent claim to arrive at a modified independent claim , with the remaining dependent claims in their original text being read and applied to any independent claim so modified . accordingly , the present invention is intended to cover all such modifications and alterations and is not intended to be necessarily limited by any one or more particular strict interpretations of the claims which now follow . whereas , the present invention has been described in relation to the drawings attached hereto , it should be understood that other and further modifications , apart from those shown or suggested herein , may be made within the spirit and scope of this invention . descriptions of the embodiments shown in the drawings should not be construed as limiting or defining the ordinary and plain meanings of the terms of the claims unless such is explicitly indicated . as such , those skilled in the art will appreciate that the conception , upon which this disclosure is based , may readily be utilized as a basis for the designing of other structures , methods and systems for carrying out the several purposes of the present invention . it is important , therefore , that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention .

US-201414192734-A

a freely rotatable binding base assembly for use on a board used in single - board sports such as snowboarding and slalom water skiing . a binding assembly mounted on and movably secured to the board , and is adapted to receive a conventional boot as worn by a rider . additional features include a locking means for selectably blocking rotation , and a clutch for braking rotation by applying side loading to the board .

fig1 and 2 show a snowboard 10 with a pair of rotatable binding assemblies 12 spaced apart along a central longitudinal axis of the snowboard . each rotatable binding assembly 12 incorporates a binding 14 having an instep element 16 and a heel element 18 . when a booted foot is inserted into binding 14 , the instep element is engaged by clamping it down onto the top of the boot , holding the boot firmly in place . the instep element prevents any forward or lateral motion of the foot relative to the binding . the heel element engages the heel of the boot and prevents any backward motion of the foot relative to the binding . a clamp 19 , for securing the instep and heel elements to the boot may be of a buckle type , velcro , lacing , or other suitable type of clamp that will hold the instep and heel of the boot locked in place on the binding . step - in or strap - in bindings are equally useful . the heel and instep elements of binding 14 are attached to a rotatable plate 20 . the bindings may be screwed to the rotatable plate , or the bindings and the rotatable plate may be designed to be a single , integral unit . the rotatable plate is mounted on a bearing 22 . the bearing may be a friction (“ plain ”) ball or roller bearing , or other suitable type of bearing which enables free rotation in the presence of both side loads and axial or thrust loads . preferably , the bearing has a low profile , enabling the boots to be close to the upper surface of the board . the bearing is mounted on an upper surface 24 of the snowboard . in one embodiment , the bearing may be mounted in a cavity 25 ( fig2 ) in the upper surface of the snowboard . an outer race of the bearing is held in place by a mounting ring 26 and screws 28 . the rotatable plate is attached to an inner race of the bearing by a cylindrical shaft or kingpin 29 secured to the plate and inner race . the bearing allows dynamic , free rotation of the binding relative to the snowboard . the dynamic , free rotation of the binding offers advantages over other board bindings , and allows easier use of the snowboard and boards used in water sports . one example of the easier use is apparent when walking . one foot may be released from a binding , and the bound foot may be aligned with the longitudinal axis of the snowboard , rather than diagonally across the snowboard . this allows walking without having the foot , and hence the knee , oriented at an abnormal angle that could result in damage to either the knee or the ankle , or both . in normal operation of the snowboard , the feet would be positioned diagonally across the snowboard , with the toes pointing toward a front end 30 of the snowboard . for certain trick maneuvers , the feet and bindings can quickly be oriented to positions perpendicular or nearly perpendicular to the longitudinal axis of the board . the operation of the rotatable binding utilizes the dynamic , free rotation of the feet bound to the snowboard . in operation , rotational torque for turning the snowboard may be obtained by applying pressure to the inner or outer edge of the snowboard , as is used with skis and other snowboards . however , the rotatable bindings also allow rotational torque to be obtained by a push / pull motion of the feet . to obtain this turning motion , one foot is pushed forward as the other is pulled back , resulting in rotation of the binding relative to the snowboard . this action results in a rapid change in direction of the snowboard , rather than the more gradual change in direction that is obtained by applying pressure to the edge of the snowboard . as a result of this rotational motion of the bindings , the snowboard is highly maneuverable . this maneuverability , plus the ability to rapidly change the orientation of the feet relative to the snowboard , makes the rotatable - binding snowboard highly suited to tricks , freestyle , and racing maneuvers . also , since the bindings are rotatable , it is possible to incorporate riding the snowboard backwards , from a normal to a “ goofy - footed ” position , into tricks and freestyle . in order for the snowboard to be ridden backwards , the snowboard is rotated through 180 °. the feet are rotated from a diagonal position with the toes directed toward the front of the snowboard , to a diagonal position with the toes pointing toward a back end 32 of the snowboard . falls are an inevitable part of most snow sports , and the rotatable bindings may be used to orient and align the feet and knees during a fall . this ability to spread impact forces results in reduced stress on knee and ankle joints , and significantly reduces the potential of injury to knees or ankles . in an alternative version of the invention , stops can be provided to limit rotational motion of the bindings to about 120 ° ( from slightly more than straight ahead to slightly more than an athwart position ). in another embodiment , a clamp can be provided , enabling one of the bindings to remain in a fixed position , while the other binding ( typically the rear binding , though the front binding may be selected for ease in exiting a chair lift ) is freely rotatable . though primarily developed for use with snowboards , the binding of this invention also believed useful with other types of rideable boards such as used in the sports of wakeboarding and slalom waterskiing . the term “ board ” as used herein is accordingly defined as an elongated board to which both of the rider &# 39 ; s feet are secured by bindings ( in contrast to conventional skis in which a pair of boards are used , one for each foot ). referring to fig3 , the embodiments thus far described relate to binding rotation around a y axis 35 which is generally perpendicular to the upper surface of a board 36 , and coincides the rotational axis of the binding . the board also has an x axis 37 which extends perpendicularly to the y axis and perpendicularly to a z axis 38 which corresponds to the longitudinal axis of the board . limited rotation about the x axis can be incorporated in a binding either alone , or in combination with y - axis rotation , and movement of one foot along the z axis is also possible . fig4 shows a board 40 with fore and aft bindings 41 mounted on hinge assemblies 42 shown in greater detail in fig5 . each assembly 42 has a lower plate 43 rigidly secured to the board by fasteners ( not shown ) extending through holes 44 . a pivot pin 45 extends through a socket - like raised central portion 46 of the lower plate , and a longitudinal axis of the pin corresponds to the x axis as described above . hinge assembly 42 has an upper plate 48 with a generally flat upper surface 49 to which a respective binding 41 is secured by fasteners ( not shown ) extending through holes 50 . a central opening 51 provides clearance for portion 46 of the lower plate . the upper plate further defines partial - cylinder seats 52 on opposite sides of opening 51 to receive the opposite ends of pivot pin 45 . axial movement of pin 45 is prevented by securing the pin to either portion 46 or seats 52 . the hinge assembly enables each binding to be rocked about the x - axis to add a different degree of freedom for the rider &# 39 ; s feet with respect to the board . x - axis and y - axis rotation can be combined by mounting the y - axis binding shown in fig1 and 2 to the top ( but preferably not beneath in order to maintain edge or z - axis control of hinge assembly 42 and board . alternatively , one binding can be of this y - axis above x - axis arrangement for edge control , and the other binding in the opposite configuration ( x - axis above y - axis ) to provide the effect of a universal ball joint . another possible configuration is to mount one of the two bindings for limited movement along the z - axis fore and aft on the board . this sliding movement can be parallel to the upper surface of the board , or can be along a rearwardly and upwardly sloping ramp on the board . the binding with such z - axis movement can also incorporate z - axis or y - axis rotation , or both . typically , a wider range of trick maneuvers become possible when additional degrees of freedom are provided in bindings . even if free binding movement is restricted to rotation about only the y axis , there are made available the important advantages of faster turns , safe landings from difficult jumps , fewer falls with reduced impact forces , a broader range of trick maneuvers , and reduced ankle and knee stress when riding and exiting a lift during snow sports . binding rotation enables optimal positioning of the feet during different riding conditions , as opposed to the single compromise positions of fixed bindings . another and presently preferred rotatable binding base assembly 55 is shown in fig6 and 7 . the assembly has a centrally positioned bearing clamp 56 with circular upper and lower plates 57 and 58 . an inner race 60 of a ball - bearing assembly 61 is clamped between radially extending flanges 62 and 63 on plates 57 and 58 which are secured together by four screws 65 arranged in a square pattern and threaded into “ t ” nuts 66 recessed into the underside of a sports board 67 . only a downwardly extending central circular portion 69 of upper plate 57 bears directly on lower plate 58 . radially outer portions 70 of the upper plate are spaced slightly from the lower plate so those portions can flex slightly when screws 65 are tightened to clamp the bearing inner race securely . plates 57 and 58 are preferably made of a lightweight metal such as aluminum . a generally elliptical binding - support assembly 72 has upper and lower plates 73 and 74 which are tightly secured together by screws 75 . inner vertical circular ribs 77 and 78 of the upper and lower plates are recessed to receive and be clamped against an outer race 79 of bearing assembly 61 . a radially inwardly extending circular flange 80 of the lower plate is spaced slightly from lower plate 58 of the bearing clamp so assembly 72 can rotate freely around base assembly 55 . four “ t ” nuts 82 arranged in a square pattern are recessed into the undersurface of upper plate 73 to receive screws for securing a binding ( not shown ) as previously described to binding - support assembly 72 . optionally , a circular opening 83 may be formed through upper plate 73 at the same radius from the center of the upper plate as the radial spacing of “ t ” nuts 82 from the center . this opening is normally closed by a circular resilient plug 84 which can be removed to enable removal of screws 65 ( during installation or removal of assembly 55 from the board ) without disassembly of binding support assembly 72 . fig8 and 9 show a modified version of binding - base assembly 55 which includes a further feature of a lock assembly 85 which enables the front assembly to be temporarily locked in a fixed position when , for example , exiting from a ski lift , or during initial training . lock assembly 85 has a thin metal baseplate 87 ( partially in phantom line in fig9 ) which is secured to the front assembly 55 and positioned between lower plate 58 and the upper surface of board 67 . the base plate extends rearwardly from assembly 55 , and is folded upwardly and inwardly to form a socket or channel 88 which receives a sliding plunger 89 having an enlarged head 90 . when head 90 is pressed forwardly , the forward end of plunger 89 is pressed into and engages a mating recess 91 in lower plate 74 to prevent rotation of the assembly . detents are preferably provided to latch the plunger in extended and retracted positions , and movement can be further restricted ( for example , by a set screw extending laterally from the plunger within a closed slot in channel 88 ) to prevent complete withdrawal of the plunger . another additional feature is a clutch assembly 92 ( fig6 and 10 ) which enables braking of free rotation by applying a side load to the board . such temporary braking may be desired when traversing icy terrain . clutch assembly 92 has an upper movable portion defined by a plurality of short circularly arranged and radially extending ribs 93 which are molded into the undersurface of lower plate 74 . a pair of fixed clutch portions 94 are positioned on opposite sides of the board . portions 94 are typically made of tough high - friction rubber , and are spaced apart only slightly from ribs during normal riding of the board . if the rider edge loads the board , flexing of the board brings the ribs into frictional engagement with the fixed clutch portions to brake the rotational movement . ribs can also be formed on portions 94 if stronger braking action is desired . although the present invention is described in relation to several working embodiments for illustrative purposes , variations will be apparent to those skilled in the art . for example , the rotatable feature could be incorporated in the rider &# 39 ; s boot without departing from the scope of the invention . therefore , the present invention is not intended to be limited to the working embodiment described above . the scope of the invention is further defined in the following claims .

US-79563604-A

an embodiment of a mapping probe assembly includes a body frame with a lumen therein . the body frame includes a catheter shaft region , a loop section and a transition region between the catheter shaft region and a loop section . a plurality of mapping electrodes are attached around the loop section . electrical conductors extend through the lumen of the body frame to the mapping electrodes . in some embodiments , the loop section is skived , where a portion of the body frame is removed toward the interior of the loop section . the loop section has a generally planar loop , and further has a loop center . in some embodiments , the catheter shaft has an alignment generally perpendicular to the loop section where the alignment of the catheter shaft is along a line that intersects the planar loop proximate to the loop center .

the following detailed description of the present invention refers to subject matter in the accompanying drawings which show , by way of illustration , specific aspects and embodiments in which the present subject matter may be practiced . these embodiments are described in sufficient detail to enable those skilled in the art to practice the present subject matter . references to “ an ,” “ one ” or “ various ” embodiments in this disclosure are not necessarily to the same embodiment , and such references contemplate more than one embodiment . the following detailed description is , therefore , not to be taken in a limiting sense , and the scope is defined only by the appended claims , along with the full scope of legal equivalents to which such claims are entitled . embodiments of the present subject matter relate to a pv mapping catheter configuration that allows the catheter to be positioned properly in the pv ostium . the design encourages the set position of the catheter to be maintained throughout the ablative procedure . the mapping loop tip is formed from a material with a shape memory , which tends to expand radially outward into contact with the interior walls of the pv ostium . the mapping loop may be designed for vessels other than the pv ostium . the catheter shaft is generally centered in relation to the mapping loop tip , which allows the catheter distal loop force pressure upon the pv ostium to be distributed in a generally uniform manner about its circumference which is in contact with the interior wall of the pv ostium . this uniformly - distributed pressure maintains a more balanced orientation and stable position of the original deployment , which improves mapping of the heart atrium or ostium of the pv before and after the ablative therapy . according to various embodiments , the loop tip includes ablation electrodes . some embodiments use electrodes for the mapping function that are different than the electrodes used to perform the rf ablation . some embodiments use the same electrodes to map and to ablate . fig2 illustrates a plan view for an embodiment of a probe assembly for a mapping catheter . the illustrated mapping catheter has a distal region of a catheter shaft 204 , and a generally planar and circular mapping loop tip 205 . the distal region of the catheter shaft 204 extends away from the page in the illustrated plan view , and is generally perpendicular to the plane of the mapping loop 205 . the loop 205 is formed with a desired loop diameter to fit within a desired vessel , such as the pv ostium , and securely expand into contact with the interior wall of the vessel . the diameter of the loop is adjustable . the shape memory of the material used to form the mapping loop tip tends to enlarge the diameter of the mapping loop , and a control wire can be used to adjust the diameter . in an embodiment of a pv mapping catheter , the diameter of the loop is approximately 10 - 30 mm . the length of a mapping catheter embodiment is within a range of approximately 100 cm to 150 cm . the diameter of the catheter is within the range of 5 to 9 fr ( 1 . 2 to 3 mm ), according to some embodiments . some catheter embodiments have a diameter within the range of 6 to 8 fr ( 2 to 2 . 7 mm ). in some embodiments , the catheter diameter is on the order of 7 fr ( 2 . 3 mm ). the diameter of the structure that defines the mapping loop tip is within the range of 2 to 9 fr ( 0 . 7 to 3 mm ), according to various embodiments . in some embodiments , the diameter of the structure that defines the mapping loop tip is 2 to 5 fr ( 0 . 7 to 1 . 7 mm ). in some embodiments , the diameter of this structure is on the order of 3½ fr ( 1 . 2 mm ). the illustrated catheter includes a transition region 206 between the distal region of the catheter shaft 204 and the mapping loop 205 . the distal region of the catheter shaft 204 is generally aligned with an axis of rotation of the generally circular mapping loop 204 . thus , in the plan view illustrated in fig2 , the catheter shaft is generally centered with respect to the mapping loop 205 . the distal region of the catheter shaft 204 , the transition region 206 and the mapping loop 205 possess a shape memory to return to a shape generally illustrated in fig2 , but also possess flexibility to be straightened when retracted in a sheath . as will be illustrated in the figures below , the distal portion of the catheter includes a body frame , a control or pull wire , a compression spring for the adjustable loop , a distal braided shaft , and outer shaft with electrodes attached . fig3 illustrates a perspective view of a body frame for an embodiment of a distal portion of a probe assembly for a mapping catheter . embodiments of the present subject matter use a body frame made of nickel titanium ( niti ) to provide shape memory . other materials that possess an appropriate shape memory may be used . because of the shape memory characteristic , the distal portion of the catheter is flexible and can be straightened inside the sheath and can maintain its original shape when is out of the sheath . according to various embodiments the loop section of the body frame is skived . in the skived portion , at least a portion of the body frame facing toward the interior of the loop is removed . the skived structure allows the design to accommodate more space for the lead wires , provides a small outside diameter profile , provides balanced distal loop flexibility , and provides a more controlled , adjustable loop . some embodiments taper the skived portion distally . the tapered distal end promotes flexibility of the distal end of the loop portion , which allows the mapping loop to be fed through the vascular more easily and to contract into a tighter loop . in the tapered embodiments , the amount of the body frame left at the proximal end of the skived portion is more than the amount of the body frame left at the distal end . for example , the skive may leave approximately half of the body frame in the skived portion , and this portion is tapered to leave approximately half of the body frame at the proximal end and approximately a quarter of the body frame at the distal end . various embodiments leave different amounts of the body frame at the distal end and different amounts of the body frame at the proximal end . the skiving and tapering is a design parameter that can be modified to provide the desired flexibility for the mapping loop , and to provide the desired thickness for the structure used to define the mapping loop . the body frame is a tubular structure with a lumen therein . the body frame includes a catheter shaft region 304 , a loop section 305 , a transition region between the catheter shaft region 304 and the loop section 305 , and a compression spring 309 positioned between the skived loop section and the transition region 306 . the loop section 305 of the body frame is skived to remove the interior portion of the loop , thereby exposing the lumen 307 and a cross section of a wall 308 of the tubular structure that defines the lumen within the tubular structure . fig4 illustrates a cross - sectional view taken along lines 4 - 4 in fig3 of the body frame . this figure generally illustrates the partial tubular shape of the skived loop section , the lumen 407 and the wall of the tubular structure used to form the body frame . fig5 illustrates a perspective view of the body frame illustrated in fig3 a , with a control wire therein , according to various embodiments . the control or pull wire may be 10 mm , 8 mm or 7 mm , according to various embodiments . the present subject matter is not limited to a particular size . the control wire is attached to the body frame toward the distal end of the loop section 305 . pushing the control wire distally tends to straighten the body frame thereby making the loop larger , and pulling the control wire proximally tends to make the loop smaller . fig6 illustrates a cross - sectional view taken along lines 6 - 6 in fig5 of the body frame . this figure generally illustrates the control wire within the exposed lumen of the skived loop section . fig7 illustrates a distal braided shaft incorporated on the distal end of the body frame , according to various embodiments . the distal braided shaft extends substantially around the loop . in some embodiments , the braid is a stainless steel wire . some embodiments form the braid using nylon , fiberglass or other thermoplastic material . the braid provides structural reinforcement to the structure of the loop , preventing the wires within the structure from rupturing the loop structure fig8 illustrates an outer shaft 812 , with electrodes 813 , incorporated over the braids on the distal end of the body frame . the outer shaft 812 may be formed from a thermoplastic material . holes are formed through the outer shaft . ring electrodes are connected around the outer shaft . wires within the catheter and loop section connect to the electrodes through these holes . according to various embodiments , the electrodes are equally spaced around the loop . in some embodiments , the number of electrodes around the loop is within a range from approximately 10 to 30 electrodes . by way of example and not limitation , some embodiments provide approximately 22 ring electrodes . in some embodiments , by way of example and not limitation , the length of the electrodes is approximately 1 - 2 mm , and the spacing between electrodes is approximately 6 mm . the length of electrodes , the spacing of electrodes , and the number of electrodes on the mapping loop may be varied . fig9 a and 9b illustrate an embodiment of a probe assembly of a mapping catheter positioned within a pulmonary vein . the mapping catheter may be positioned within the pv ostium . as illustrated , the loop section 905 expands into contact with the interior wall of the pulmonary vein 914 , and the distal portion of the catheter shaft 904 is approximately centered within the pulmonary vein , as it is generally aligned with the axis of rotation of the loop section 905 . this design enables the loop section 905 to expand against the wall of the pulmonary vein with a general uniform pressure . the area of the loop section in contact with the wall of the pulmonary vein is generally uniform around the diameter of the pulmonary vein , and the distal portion of the catheter shaft does not tend to pull one portion of the loop section away from the wall of the pulmonary vein , as would occur if the catheter shaft was tangential to the loop section . this allows the catheter to be securely positioned and provide a stable orientation for the mapping electrodes 913 throughout the procedure . fig1 illustrates a mapping catheter system embodiment . the illustrated catheter includes the loop section 1005 with mapping electrodes 1013 to provide a probe assembly for pv mapping . although the probe assembly is described in conjunction with pulmonary vein tissue , the probe assemblies may be used for other body tissues . although the electrodes are described below as mapping electrodes , in alternative embodiments , the electrodes may be multi - functional electrodes used for mapping , pacing , and / or ablating body tissue . the catheter can be functionally divided into four regions : the operative distal probe assembly region ( e . g . the distal portion of catheter body 1004 and the loop section 1013 ), a main catheter region 1015 , a deflectable catheter region 1016 , and a proximal catheter handle region where a handle assembly 1017 including a handle is attached . a body of the catheter may include tubular element ( s ) to provide the desired functionality to the catheter . the catheter may also include a sheath 1018 that , when the probe assembly is moved proximally into the sheath , the sheath collapses the probe assembly . moving the probe assembly out of the sheath allows the loop to be deployed . the deflectable catheter region 1016 allows the catheter to be steered through the vasculature of the patient and allows the probe assembly to be accurately placed adjacent the targeted tissue region . a steering wire ( not shown ) may be slidably disposed within the catheter body . the handle assembly may include a steering member to push and pull the steering wire . pulling the steering wire causes the wire to move proximally relative to the catheter body which , in turn , tensions the steering wire , thus pulling and bending the catheter deflectable region into an arc . pushing the steering wire causes the steering wire to move distally relative to the catheter body which , in turn , relaxes the steering wire , thus allowing the catheter to return toward its form . to assist in the deflection of the catheter , the deflectable catheter region may be made of a lower durometer plastic than the main catheter region . a mapping signal processor may be coupled to the catheter , allowing a physician to map the electrical activity in the target tissue site before , during and / or subsequent to the ablation process . the mapping processor is in electrical communication with the mapping electrodes 1013 via a mapping cable 1019 and the signal wires . the signal wires may be routed , through a mapping wire tubular member in the catheter body . the following description for placing the probe assembly is provided by way of example , and not limitation . the probe assembly is in a collapsed condition when introduced into a patient &# 39 ; s body . placement of the catheter within the vasculature of the patient is typically facilitated with the aid of an introducer guide sheath or guide wire , which was previously inserted into the patient &# 39 ; s vasculature , e . g ., femoral vein . the introducer guide sheath is introduced into the left atrium of the heart using a conventional retrograde approach , i . e ., through the respective aortic and mitral valves of the heart . one or more well - known visualization devices and techniques , e . g ., ultrasound , fluoroscopy , etc ., may be used to assist in navigating and directing the catheter to and from the targeted region . alternatively , the introducer guide sheath may be introduced into the left atrium using a conventional transeptal approach , i . e ., through the vena cava and atrial septum of the heart . in either a conventional retrograde approach or transeptal approach , the catheter is introduced through the introducer guide sheath until the probe assembly resides within the left atrium . once inside the left atrium , the physician may deliver the probe assembly into a desired pulmonary vein through rotational movement of the steering knob on the catheter handle . the physician situates the probe assembly within a selected tissue region in the interior of the pulmonary vein , adjacent to the opening into the left atrium . the probe assembly is deployed , where the sheath slides away from the probe assembly , removing the compression force thereon . when the probe assembly expands , mapping electrodes contact the pulmonary vein tissue . these mapping electrodes are used to sense electrical activity in the pulmonary vein tissue , and may be used to pace pulmonary vein tissue as well . mapping data received and interpreted by the mapping signal processor is displayed for use by the physician to locate aberrant pulmonary vein tissue . the probe assembly may be moved one or more times , which may require collapsing and deploying the probe assembly one or more times , in an effort to locate aberrant pulmonary vein tissue . this application is intended to cover adaptations or variations of the present subject matter . it is to be understood that the above description is intended to be illustrative , and not restrictive . the scope of the present subject matter should be determined with reference to the appended claims , along with the full scope of legal equivalents to which such claims are entitled .\

US-201313894035-A

a pelvic support configured to support a pelvis and configured to take up at least one tensile stress , wherein the tensile stress is initiated in at least one lower extremity connected to the pelvis , comprising at least one support , wherein the at least one support comprises at least one supporting surface , wherein the at least one supporting surface is arranged near at least one of a ischial tuberosity of the pelvis and is configured to take up the tensile stress at the at least one ischial tuberosity .

the following detailed description refers to the accompanying drawings that show , by way of illustration , specific details and embodiments in which the invention may be practiced . the word “ exemplary ” is used herein to mean “ serving as an example , instance , or illustration ”. any embodiment or design described herein as “ exemplary ” is not necessarily to be construed as preferred or advantageous over other embodiments or designs . the following expressions are used for the orientation around a body 1 of a living being : “ anterior ” ( medical : ventral ) refers to the face of the body in which direction , for example , the abdomen is , “ posterior ” ( medical : dorsal ) refers to the back of the body in which direction , for example , the back is , “ left ” and “ right ” refer to the left and right side of the body , from the point of view of the described person . the direction in which , for example , the arms and the lower extremities leave the torso , “ superior ” ( medical : cranial ) refers to the end of the body in which direction , for example , the head is , “ inferior ” ( medical : caudal ) refers to the end of the body in which direction , for example , the lower extremities are , “ near ” ( medical : proximal ) refers to parts which are in the direction of the centre of the body , such as the heart , and “ far ” ( medical : distal ) refers to parts which are in the direction to the outer parts of the body , such as the skin , or the extremities . fig2 shows a pelvis 5 in an anterior view . the pelvis 5 consists of a left and a right hip bone ( os coxae ) 6 and the sacrum ( os sacrum ) with coccyx ( os coccygis ) 11 . the hip bones 6 are connected via the sacrum 11 and the upper pubic bone ( os pubis ramus superior ) 20 and the lower pubic bone ( os pubis ramus inferior ) 21 via the symphysis ( symphysis pubica ) 9 . the pubic nerve 10 arises from the sacrum 11 , and runs partly along the internal side of the lower pubic bone 21 , leading for example , to the outer genitals ( only the left pubic nerve is shown in fig2 ). there a more nerves leaving the sacrum 11 leading to the anal and perineal region , which are not shown . the lower pubic bone 21 is shaped like an arch . its most inferior parts are the ischial tuberosities ( tuber ischiadicum ) 8 . fig3 shows the view of a pelvis 5 from the right side . the right hip bone 6 is not shown , so that the course of the pubic nerve 10 can be illustrated . the pubic nerve 10 leaves the sacrum 11 and runs on the internal side 18 of the ischial tuberosities 8 up to below the symphysis 9 . the hip bone 6 has an crest ( crista iliaca ) 7 , an anterior superior iliac spine ( spina iliaca anterior superior ) 12 and an anterior inferior iliac spine ( spina iliaca anterior inferiorly ) 22 . fig4 shows a pelvis 5 viewed from below showing the connection of the hip bones 6 via the symphysis 9 and the sacrum 11 . the left side also shows the course of the pubic nerve 10 running from the sacrum 11 to the symphysis 9 along the lower pubic bone 21 . the ischial tuberosities 8 are shown hatched . the anterior inferior iliac spines 22 are also shown . in fig1 , the post 4 protrudes into the region between the two ischial tuberosities 8 and compresses soft tissues and / or nerves between the ischial tuberosities and the pubic bones like for example the pubic nerve 10 on the internal side of the lower pubic bone 21 . the embodiments of the pelvic support avoid pressure damages by supporting the forces and / or torques which oppose the tractive force fz at locations of the pelvis 5 where none of the abovementioned pressure - sensitive soft parts are . the forces and / or torques are directly applied via skin and subcutaneous tissues to the bone of the pelvis 5 . these locations of the pelvis 5 are distinguished , for example , by the fact that they are to be felt easily from the outside , because they directly under the skin and no pressure sensitive soft parts lie between the skin and bony support points . examples of such places are the ischial tuberosities 8 , the iliac crest 7 , the anterior superior iliac spine 12 , anterior inferior iliac spine 22 and the upper border , as well as the anterior part of the symphysis 9 . the pelvic support is shaped such , that the tensile stresses fz can not induce a force resulting in pressure on the internal sides 18 of the ischial tuberosities 8 or the lower pubic bone 21 and such , that torques induced by the tensile stress do not act on the soft parts which are , e . g ., between the ischial tuberosities 8 or the lower pubic bone 21 . fig5 shows an embodiment of the pelvic support as a one - piece support 13 where only the ischial tuberosities 8 from the pelvis 5 of fig2 are shown . the tissue between the ischial tuberosities 8 and the support 13 is also not shown . fig5 shows a plan view of the support along the y direction as shown in fig2 , while fig1 , in a view along the x direction as shown in fig2 , shows an example how the pelvis 5 , the support 13 and the base support 1 , may be arranged . it is intended to support the pelvis 5 via a support 13 which has a flat supporting surface 14 . the supporting force fs induced by the tensile stresses fz is taken up directly at the ischial tuberosities 8 . as the ischial tuberosities 8 are anatomically suitable to take up large compressive forces , significant pressure damages will be avoided . the flat supporting surface 14 avoids a protrusion of the support 13 into the space between the ischial tuberosities 8 , so that a damage of the nerves 10 by the supporting force fs is precluded . fig6 shows another embodiment of a one - piece support 13 to support the pelvis , similar to what has been said about fig5 . in contrast to fig5 , the supporting surface 14 of the support 13 is shaped concave which also precludes a damage of the nerves 10 by the supporting force fs . also , the supporting surface 14 may be shaped with different curvatures , for example , there may be an increase in curvature originating at the left and the right sides of the supporting surface 14 towards the centre of the supporting surface 14 , so that a lateral fixation of the pelvis 5 takes place by a wedge effect . the supporting surface 14 may have a curvature in one direction , as in the shape of a groove , or in several directions , as in the shape of a shell . in particular , the supporting surface 14 may have a three - dimensional shape which corresponds to the contours of the ischial tuberosities 8 , so that the pelvis 5 is fixed in several directions , thus decreasing the risk of a dislocation . fig7 shows the supporting surface 14 , in a plan view along the z direction as shown in fig2 , of an implementation of a one - piece support 13 as described , for example , with reference to fig5 or 6 . only the lower pubic bones 21 which are connected by the symphysis 9 as well as the ischial tuberosities 8 of the pelvis 5 are shown . the supporting surface of the ischial tuberosities 8 on the supporting surface 14 is shown hatched . the support 13 is dimensioned in such a fashion , that the length l 1 and the width l 2 corresponds to varying distances sa between the ischial tuberosities 8 of different pelvic sizes . the dimensioning is such , that even if there is motion of the ischial tuberosities 8 on the support 13 , it is ensured , that these do not leave the support 13 . the support 13 shows a cutout 16 in the region of the symphysis 9 . the cutout 16 is intended to circumvent pressure damages to the outer genitals by the support 13 due to a tilting of the pelvis 5 caused by the tensile stress fz . fig8 and 9 show embodiments of a two - part support 13 . what has been said to fig5 applies also here , except for the two - part implementation of the support 13 . in order to account for different distances sa between the ischial tuberosities 8 , the support 13 is made of two parts , where the distance between both supports 13 is adjustable and lockable . fig8 shows , for example , the smaller ischial tuberosities distance sa of a male pelvis 5 , while fig9 shows the bigger ischial tuberosities distance sa of a female pelvis 5 . because the distance between the supports 13 is adjustable , the sum of the areas of their supporting surfaces 14 may be made smaller than the area of a supporting surface 14 in a one - piece implementation of the support 13 , thus providing a better handling of the support 13 and a better access to the person 1 . if the supports 13 are small in size and the distance between them is large enough , a cutout 16 , as shown in fig7 , becomes obsolete . the two - part supports 13 as described in the following figures from 10 to 13 can be adjusted and be locked in their distances to each other , as described in fig8 and 9 . fig1 shows an embodiment of a two - part support 13 whose supporting surfaces 14 are concave . in contrast to fig8 the ischial tuberosities 8 are not shown , however , each ischial tuberosity 8 can be supported by a support 13 . this also applies to the embodiments shown in fig1 , 12 and 13 . the concave shape of the supporting surfaces 14 allows for a better fixation of the ischial tuberosities 8 , so that a dislocation of the pelvis 5 is less probable . the curvature may be solely in one direction , as in the shape of a groove , or in several directions , as in the shape of a shell . a good fixation of the pelvis 5 is possible , if the supporting surfaces 14 have a shape which corresponds to the three - dimensional shape of the single ischial tuberosity 8 . it is important to ensure however , that the supports 13 do not protrude into the region between the ischial tuberosities 8 where they would compress the nerves in this region , as for example the pubic nerve 10 . fig1 shows an embodiment of a two - part support 13 whose supporting surfaces 14 are shaped convex . the supporting force fs can be concentrated on the ischial tuberosities 8 by the convex shape . however , by doing so , an additional support 17 may be necessary to avoid dislocation of the ischial tuberosities 8 from the supporting surfaces 14 . fig1 shows an embodiment of a two - part support 13 with enlarged side panels 15 . the side panels 15 allow a lateral fixation of the pelvis , for example , by the thighs to the left and to the right of the side panels 15 . in this manner lateral dislocation of the pelvis 5 on the supports 13 may also be avoided . the transition from the supporting surfaces 14 to the side panels 15 is rounded , so that injuries to the person 3 are avoided . the side panels 15 may be also used in conjunction with the one - piece supports 13 . fig1 shows an embodiment where the supports 13 are fashioned in a way , that they form lever points 19 for the lower extremities 2 . the supports 13 show level supporting surfaces 14 which may be also shaped as shown in fig1 and 11 . as described in connection with fig1 , the supports 13 have side panels 15 which are in contact with the lower extremities 2 . however , these panels are longer and converge at their ends . this design provides lever points 19 at the side panels 15 which may be used to exert a force on the lower extremities 2 , in vicinity to the hipjoint of the pelvis 5 . if a force is applied to the lower extremity 2 , as for example to a thigh , which is at a larger distance from the lever point 19 than the distance between the lever point or fulcra 19 and the joint , the exerted force results in a larger force in the joint , than if no lever points 19 is used . the fulcra may also be used to align the fragments of bone fractures . a sufficient mobility of the lower extremities 2 is ensured by the convergence of the side panels 15 at their ends . the transitions from the supporting surfaces 14 to the side panels 15 are rounded like in fig1 , to avoid injuries . a one - piece support 13 may be also used instead of the two - part support 13 . fig1 shows an embodiment with two - part supports 13 with a tiltable mounting of supports 13 . in fig1 the lines marked a show the non - tilted state of the supports 13 , lines marked b and c show tilted states . the supports 13 may be tiltable not only in the shown manner , but also in a second or third direction . a three - dimensional tilting may be achieved , for example , by a ball and socket joint . the tilting of the supports 13 may be lockable . tilting the supports 13 may be used to align the supporting surfaces 14 to the contact surface of the ischial tuberosities 8 , such that they are at right angles . thus only forces arise , which are normal to the supporting surfaces 14 . in this situation shear forces in the plane of the supporting surfaces 14 do not exist , so that dislocation of the ischial tuberosities 8 on the supporting surfaces 14 is minimised . instead of implementing level supporting surfaces 14 , the supporting surfaces 14 , as shown in fig1 and 11 may be also used . this embodiment may also be combined with other embodiments , such as those shown in fig8 , 12 and 13 . the tiltable supports 13 of fig1 may also be used to fix the pelvis 5 . for this , they are brought into a position shown by the lines marked c . in position c , the normal force acting on the ischial tuberosities 8 is compounded by a lateral force . by this , a swivelling or a sideways motion of the pelvis 5 may be prevented . the supporting surfaces 14 may be shaped to show a step or a bend , so that at least part of the supporting surfaces 14 is more at right angles to the tensile stress fz , than that part of the supporting surfaces 14 which exerts the lateral force on the ischial tuberosities 8 . fig1 shows an embodiment of a swivelling pelvic support which may be rotated around a centre z . the axis of rotation may be along the y - direction as shown in fig2 . lines marked a show the non - rotated state of the supports 13 , while the lines marked b show the rotated state of the pelvic support . a rotation or tilting of the pelvic support may also take place around the second or third axis of rotation and may be limited by a block . tilting or rotating the pelvic support allows for an optimal positioning of the person 3 for the intended examination or treatment . fig1 to 18 show embodiments illustrating how the supporting surfaces 14 of two - part supports 13 may be shaped . in these figures , the supports 13 are shown from above , as in fig7 , i . e . in the direction of the ischial tuberosities 8 . fig1 shows supports 13 with a supporting surface 14 , which is just large enough to support the ischial tuberosities 8 . fig1 shows supports 13 which have enlarged supporting surfaces 14 compared to those in fig1 . the longer side of the supporting surfaces 14 is so dimensioned , that it reaches at least from the ischial tuberosities 8 up to the symphysis 9 . by this , the outer genitals are protected by the supports 13 , should the ischial tuberosities 8 slip on the supporting surfaces 14 . fig1 corresponds to the embodiments shown in fig1 whereby an additional cutout 16 is provided in the region of the symphysis 8 to allow space for the outer genitals . fig1 shows the forces and torques which act on the pelvis 5 during distraction . a person 3 is shown lying supine on a base support 1 . the base support 1 may be , for example , an operating table . it may also be a plate designed to be suitable for use in image acquisition , for example magnetic resonance imaging or computer tomography . the tensile stresses fz acting on the lower extremity 2 is taken up by the support 13 . the support 13 may be shaped as described above and may be connected with the base support 1 . hence , the tensile stress fz acts on the hip 5 and the supporting force fs acts on the ischial tuberosities 8 via the skin and tissue between the skin and the ischial tuberosities 8 . as there is a distance “ a ” between the tensile stress fz and the supporting force fs , a torque d results , which acts on the pelvis 5 . to neutralize this torque d , and thus avoid a tilting of the pelvis 5 , a force fg must act on the pelvis 5 to cause a torque in the opposite direction . hence an additional support 17 as in shown in fig2 can be provided to create the opposing force fg . fig2 shows an embodiment of an additional support 17 , the directions x , y and z are referred to as described in fig2 . a base support 1 , to which an additional support 17 is connected , is shown . the additional support 17 is fixed by , for example , by screwing it to a side of the base support 1 , which is aligned for example along the z axis . the additional support may also be connected to the base support 1 via a plug and socket assembly . the additional support 17 features a supporting area 23 to applying an opposing force fg on the pelvis 5 . the supporting area 23 may be upholstered like the other surfaces which have contact with the body , to prevent injuries to the person . the distances y , x and z between the additional support 17 and the base support 1 may be chosen arbitrarily . in particular , the additional support 17 may be positioned in such a way , that the opposing force fg is exerted on certain areas of the pelvis 5 , such as the iliac crest 7 , the areas to the left and to the right of the symphysis 9 , the anterior superior iliac spine 12 and the anterior inferior iliac spine 22 . fig2 shows the additional support 17 mounted only on one side . the supporting area 23 may be made in dimensions such that the opposing force fg , directed to the areas mentioned in the last sentence , may be exerted simultaneously to the left and right side of the pelvis 5 . the additional support 17 may be also complemented with further additional supports 17 on the same or opposite side of the base support 1 , where each of the additional supports 17 exerts a part of the opposing force fg on the best suited areas of the pelvis 5 as mentioned above . if the person 3 to be examined or operated on is lying prone on the base support 1 , a counter clockwise torque acts on the pelvis 5 . in this position , the anterior iliac crest 7 and the anterior superior iliac spine 12 lie on the base support 1 , so that a tilting of the pelvis 5 is at least partially prevented by them . in this case , the additional support 17 is provided by at least the base support 1 which is designed to take up the torque , for example , by a corresponding stiffness . a similar situation arises , if the person 3 is lying lateral on the base support 1 . although the additional supports 17 shown in fig2 can only an exert an opposing force fg in the y direction , thus preventing a tilting / rotation of the pelvis 5 in the x - axis , it may also be fashioned in such a way , that it also prevents a tilting or rotation of the pelvis 5 in the y - and / or the z - axis . this allows for a stabilisation of the pelvis 5 in the y - axis in such a manner , that distraction may be achieved by raising a tensile stress fz on only one of the lower extremities 2 . thus , the supporting forces fs and the opposing force fg acting on the pelvis 5 during distraction , may be halved compared to the forces acting when a tensile stress fz acts on both lower extremities 2 as in fig1 . it is thus likely , that pressure damages are less likely . the reduction of the acting forces allow a reduction of the mechanical demands on the base support 1 and on the device which produces the tensile stress fz . another advantage of the one - sided distraction lies in the fact , that in contrast to fig1 , the healthy lower extremity 2 , which is not to be treated or to be examined , is not subjected to tensile stresses fz , and thus its foot , knee and pelvic joints are not distracted and possibly injury by the acting forces are avoided . the additional pelvic fixation by at least one additional support 17 also allows application of the supporting force fs at only one of both ischial tuberosities 8 as induced torques may be counteract . fig2 shows another embodiment of an additional support 17 in which the pelvis 5 is fixed by a strap 17 on the base support 1 . the strap 17 courses , for example , across the anterior superior iliac spines 12 from the left side to the right side of the base support 1 in the x direction . thus motion of the pelvis 5 in the y - and x - direction , as well as a tilting / rotation of the pelvis 5 in the x - axis may be limited by the strap 17 . fashioning strap 17 with a greater breadth in the z direction , or using a second strap such that it courses in the x direction , to cross for example the anterior inferior iliac spines 22 , may also prevent a tilting / rotation of the pelvis 5 along the y - axis . fig2 shows an embodiment of an additional support 17 which is connected to the support 13 . the support 13 exerts a supporting force fs on the ischial tuberosities 8 , while the additional support 17 exerts an opposing force fg on the anterior superior iliac spines 12 . the opposing force fg may also act on the iliac crest 7 or on the anterior inferior iliac spines 22 . the additional support 17 may also be shaped such that it can act on an arbitrary combination of anterior superior iliac spines 12 , iliac crest 7 and anterior inferior iliac spines 22 . the torque d induced by the tensile stress fz and the supporting force fs are thus taken up directly at the combined pelvic support , composed of support 13 and additional supports 17 . the torque may thus be transmitted to the base support 1 via support 13 if it is fixed accordingly to the base support 1 , for example by screw fixation . the torque may also be transmitted to the base support 1 by another additional support , e . g ., by a strap from fig2 , where the strap passes , for example , across the anterior superior iliac spine 12 via the additional support 17 . the support 13 may be also fixed at an angle to the surface of the base support 1 such that the support 13 is tilted towards the pelvis 5 to induce a wedge effect , which presses the pelvis 5 to the base support 1 , thus providing additional fixation of the pelvis 5 . fig2 shows an embodiment of an additional support 17 which is connected to the support 13 as shown in fig2 , so that explanations to fig2 also apply to this embodiment . in contrast to fig2 however , the opposing force fg in fig2 acting via the additional support 17 does not act on the anterior superior iliac spines 12 , the iliac crest 7 or at the anterior inferior iliac spines 22 , but at the areas on the left and right of the symphysis 9 on the inferior pubic bone 21 via the skin and the underlying subcutaneous tissues at places which are suited to accept pressure forces . fig2 shows a perspective view of an assembly of a base support 1 with two - part supports 13 and additional supports 17 . the directions x , y and z are also indicated . the tensile stress fz and the forces fg opposing the resultant torque d may be measured using one or several force sensors in the additional supports 17 and the supports 13 , so that the lower extremities 2 may be shielded against overly large tensile stresses fz . there may also be at least one pressure measuring matrix implemented in the supports 13 and additional supports 17 , by which the acting forces may be measured . instead of using a pressure measuring matrix , a pressure sensor may be also used . be analysing the spatial pressure distribution as measured by the pressure measuring matrix , it is not only possible gain information about the total acting force , but , for example , also about the location of the acting forces . if for example , the pressure measuring matrix indicates a small area with high pressure , the probability is high , that the supporting force fs is acts normally , that is vertically , to the ischial tuberosities 8 . if a bigger area with lower pressure is indicated however , it is likely that the supporting force fs is also acting on the soft tissues surrounding the ischial tuberosities 8 . the pattern of the pressure distribution may provide information about the direction of forces which are not along the normal forces . using this information , it is possible to position the supports 13 and additional supports 17 in such a way that soft tissue injury may be avoided . the embodiments described above may be combined arbitrarily — as long as they do not contradict each other . the pelvic support may be also used for other vertebrates , as for example dogs , cats , cows , horses and elephants . while the invention has been particularly shown and described with reference to specific embodiments , it should be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention as defined by the appended claims . the scope of the invention is thus indicated by the appended claims and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced . a distance between the vectors of tensile stress and supporting force

US-201213523226-A

a method for use with an implantable cardioverter defibrillator apparatus of the type having a microprocessor - based control circuit , a charging circuit communicatively connected to the control circuit , a small charge storage capacitor , a large charge storage capacitor , switches , and charge output terminals , of delivering a preemptory shock to a patient , comprising the steps of a .) receiving physiological information pertaining to the onset of a deleterious cardiac event ; b .) charging the small charge storage capacitor in the implantable cardioverter defibrillator apparatus immediately after step ; c .) reviewing the information to confirm the onset of a cardiac event ; and d .) delivering a preemptory charge from the small charge storage capacitor to the patient if the onset of a cardiac event is confirmed . an apparatus for practicing the above method is also discussed .

referring to fig2 the implantable cardioverter defibrillator apparatus 20 of the present invention basically comprises a control circuit 21 , preferably microprocessor based , a charge circuit 22 , a relatively large capacitor 23 of 50 - 100 microfarads ( μf ), preferably 90 μf , and a smaller capacitor 24 of 10 - 50 μf , preferably 15 μf . the large capacitor 23 stores 0 - 30 joules ( j ) of energy , preferably 5 . 6 j and a small capacitor 24 stores 0 . 1 - 5 j , preferably 1 . 5 j . a pair of switches 25 and 26 are connected between electrode terminals 27 and 28 and the capacitors 23 and 24 , respectively . the larger capacitor 24 is used in a conventional manner to deliver high energy defibrillation or small cardioversion pulses . the smaller capacitor 24 is utilized to provide a preemptory shock as will be described further below . the charge circuit 22 includes battery means and is utilized to charge the capacitors 23 and 24 when directed to do so by the control circuit 21 . the control circuit 21 has input means 29 to receive physiological information related to cardiac function . the method of the present invention involves a multi - step process which is implemented by program instructions in the microprocessor based control circuitry 21 of the implantable cardioverter defibrillator 20 . the method enables the provision of cardioverter defibrillator therapy in patients having and implantable cardioverter defibrillator as soon as possible after onset of a predetermined cardiac event . referring again to fig1 in the first step 30 of the method , the icd either detects or predicts the onset of an arrhythmia , possibly a fibrillation . such detection may be made by first detecting the presence of a burst of &# 34 ; n &# 34 ; number of high rate heartbeats , this being indicative of a potential arrhythmia . the rate of such beats is approximately 200 beats per minute . the number of such beats is approximately 3 . this initial alert signals the microprocess 21 and the device 20 begins to process incoming data by a conventional algorithm . an alternative method for the initial phase of the process of this invention involves predicting or anticipating the occurrence of fibrillation as is described in slope filtered pointwise correlation dimension algorithm and evaluation with prefibrillation heart rate data , by m . w . kroll and k . w . fulton . this method involves the use of a heart rate variability algorithm to anticipate the onset of fibrillation . although this method is preferred , still other methods exist for detecting or predicting the onset of fibrillation , for example one based on waveform morphology , rate acceleration , or rate stability and they too may be utilized in this initial phase , consistent with the overall teachings of this invention . the slope filtered pointwise correlation dimension algorithm is used to predict eminent fibrillation and involves the following process : ii ) calculate the slope of log n versus log r for these 10 points (= d &# 39 ;). continue &# 34 ; plotting &# 34 ; log n versus log r until n = 1 , 000 . iii ) find longest length of plot with & lt ; 30 % wiggle from d &# 39 ; value . iv ) set d 3 = the slope of this length of the plot . 2 . calculate &# 34 ; saturation deviation &# 34 ;= std . dev . { d 9 , d 10 , d 11 , d 12 }. in the above - referenced pseudocode for each point in a data set , &# 34 ; wiggle &# 34 ; is the maximum change in δ log n / δ log r ( the &# 34 ; slope &# 34 ;) as r increase . the slope filtered pointwise correlation dimension algorithm calculates a correlation dimension for each point in a data set . it begins by fixing a point to use as an origin . saturation deviation is the measure of the convergence of the dimension estimates as the embedding dimension increase . the algorithm finds the longest length of stable slope and calls that the dimension ( d e ) for that embedding dimension e . the standard deviation of the last four d e s ( referred to as the saturation deviation ) must be less than 0 . 4 for the point to be accepted to provide a trustworthy estimate of the correlation dimension . it is the interaction of the wiggle factor and the saturation deviation that leads to the acceptance of a given origin point for an independent estimate of the correlation dimension . the slopes are used to filter the pointwise correlation dimension estimate . the slope filtered pointwise correlation dimension gives a result at most points and is accurate at those points . the algorithm has been validated on mathematical data with known correlation dimensions . the algorithm has also been utilized in animal and clinical studies wherein it was found that the pointwise correlation dimension of heart rate data , as calculated by the slope filtered algorithm , appears to predict fibrillation in ischemic animals and in human arrhythmia patients . this process is used in the initial phase 30 of the present invention to anticipate arrhythmia or fibrillation before its actual onset to allow capacitor charge up to take place at an early stage as is described below . upon receiving the initial alert 30 , the small capacitor 24 is immediately charged 31 . this step 31 takes approximately 1 - 2 seconds . alternately , the small capacitor may be a low leakage device which is continuously charged . at the conclusion of the small capacitor charging phase 31 , the small capacitor is discharged during interval 33 across the heart providing the peremptory shock . alternatively an additional step 32 in the method is to reevaluate the detection or anticipation made in the initial phase 30 , and if reconfirmed , then discharge the small capacitor 24 during interval 33 across the heart to provide the preemptory shock 36 . if the initial phase 30 involves the detection of high rate beats , a second look at the succeeding heartbeat interval is taken , and confirmation is made if the interval is still short . if anticipation was made by the slope filtered pointwise correlation dimension algorithm , confirmation may be made by noting a sustained high rate , for example . the total elapsed time from the first fast beat to the initial or preemptory shock is on the order of 2 - 3 seconds but importantly is less than 3 seconds . the term &# 34 ; preemptory &# 34 ; as used herein to describe the initial pulse or shock refers to that pulse which is delivered first after arrhythmia onset and wherein normally applied detection criteria for confirming and diagnosing heart rhythm is bypassed . if the heart arrhythmia is successfully converted , the large capacitor 23 is not charged . if the arrhythmia is not converted , conventional detection 34 continues along with charging 35 of the large capacitor 23 . the cardioverting or defibrillating pulse 36 may then be delivered . utilizing the circuitry 20 disclosed above , wherein the small capacitor 24 is 20 μf and the large capacitor 23 is 90 μf , and assuming they are both charged to the same voltage , approximately 750 volts ( v ), approximately 5 . 6 joules ( j ) of energy is expended utilizing the method of this invention . in contrast , a typical icd utilizes approximately 25 j energy . thus , approximately 2 / 9ths of the energy normally required is used by practicing this method . moreover , the small capacitor 24 is typically charged to an even lower voltage , approximately 380 v , or at a 1 . 5 j energy level . this results in a clear energy savings . although the preferred apparatus embodiment for practicing the method of this invention comprises separate and distinct large and small capacitors , it is within the purview of the invention to utilize a single large capacitor to discharge both the large and small shocks since charge time is proportional to stored energy regardless of the value of the capacitor . another advantage of this method is that the low value capacitor utilized also presents lower leakage currents than does a large capacitor . this is particularly important where the small capacitor is kept continuously charged . also , where an anticipatory method is utilized in the initial phase , the lower charging current allows the device 20 to have a longer anticipatory period in the initial phase . and finally , with respect to the anticipatory initial phase , the low charging currents would allow pre - charging of the smaller capacitor to further increase the effectiveness of the preemptory pulse by allowing it &# 39 ; s shock to be delivered still sooner after the start of an arrhythmia . the small capacitor 24 shock pulse width is delivered with a pulse width of about two milliseconds . this coincides with the ideal pulse width for cardioversion . thus , a pulse delivered from the small capacitor 24 soon after the onset of arrhythmia would have a higher probability of cardioversion success with a lower probability of acceleration of the rhythm to fibrillation than conventional cardioversion pulses . such a pulse may also be more effective for defibrillation than a conventional high energy pulse delivered later in the episode . fig3 shows a comparison of defibrillation s - d curves 40 , 41 , and 42 with a cardioversion s - d curve 43 . no data exists for defibrillation s - d curves for duration &# 39 ; s less than approximately 10 seconds . it is , however , expected that additional s - d curves for defibrillation lie between the cardioversion s - d curve 43 and the 10 second defibrillation s - d curve 42 . as many changes are possible to the embodiments of this invention utilizing the teachings thereof , the descriptions above and the accompanying drawings should be interpreted in the illustrative and not the limited sense .

US-12289493-A

providing fluid to an internal delivery site of a patient includes moving the fluid from a fluid reservoir through a conduit and through a delivery device at the delivery site while maintaining the fluid at a predetermined pressure . the delivery device may comprise an inflatable balloon with apertures formed in its periphery for directing the fluid into the vessel walls . pressurized fluid is provided through the apertures of the balloon to the vessel wall . the pressure is automatically controlled to avoid both pressure spikes and unacceptable deflation of the balloon during administration of the fluid . a further feature includes comparing the pressure with the volume infused and in the event that pressure decreases while the volume infused increases beyond certain limits , the delivery of the fluid is stopped . further features include a timer for limiting the inflation time of the delivery device and a volume detector for controlling the amount of fluid delivered . in one described embodiment , a pneumatic driver system is used to pressurize the fluid .

referring now to the drawings with more particularity , wherein like reference numerals designate like or corresponding elements among the several views , there is shown in fig1 an automated fluid pressure control system 10 which provides a fluid to a fluid delivery device 12 . the fluid delivery device 12 may comprise an inflatable balloon having apertures through which the supply fluid is locally administered to a delivery site internal to the body of a patient . the delivery site may comprise the walls of a blood vessel . a reservoir 14 containing the fluid to be delivered is connected to the delivery device 12 by a conduit , such as a lumen of a catheter 16 . a driver 18 provides pressure to move the fluid from the reservoir 14 through the catheter 16 to the delivery device 12 . the pressure provided by the driver 18 is selected to maintain the balloon in the inflated state and force the fluid through the apertures of the balloon into the vessel walls . the pressure is maintained high enough so that the fluid leaving the balloon will only be administered to the walls of the blood vessel and will not flow to any significant extent into the bloodstream . at the same time , the pressure is not so high as to cause damage to the vessel . the size of the balloon is selected such that when inflated , some pressure will be applied by the balloon to the vessel walls to confine the apertures to intimate contact with those vessel walls . a balloon having a size too small will allow the medical fluid leaving the apertures to be swept away by the bloodstream while a balloon with a size too large may cause damage to the vessel when inflated . a pressure sensor 20 in this embodiment senses the pressure in the conduit between the reservoir 14 and the delivery device 112 and provides a sensed pressure signal to a controller 22 . the controller 22 compares the sensed pressure to a desired administration pressure and outputs an error signal in the event that they differ . the error signal is provided to the driver 18 which alters the pressure of the medical fluid to attain the desired administration pressure . in the embodiment shown in fig1 the driver 18 alters the volume of the reservoir 14 thereby controlling the pressure of the fluid in the system . because the delivery device 12 permits the outflow of the fluid provided by the reservoir 14 , the driver 18 must continually empty the reservoir 18 to maintain the desired administration pressure . in the event that the sensed pressure is less than the desired administration pressure , the rate at which the reservoir 14 is emptied by the driver 18 will be increased to raise the pressure . in the event that the sensed pressure is above the desired administration pressure , the rate at which the reservoir 14 is emptied by the driver 18 will be decreased to lower the pressure . in another feature , the controller 22 may also receive a reverse control signal 24 from an operator in which case the controller 22 will control the driver 18 to stop the flow of the medical fluid . in the case where an inflatable balloon is used as the delivery device , the driver may reverse the flow to deflate the balloon and to assure that none of the medical fluid leaves the delivery device 12 during withdrawal from the patient . the driver 18 may accomplish this by increasing the volume of the reservoir thereby creating negative pressure . in another aspect shown in fig1 a volume detector 26 determines the amount of fluid delivered to the delivery device 12 and provides a volume signal to the controller 22 . the volume signal is compared by the controller 22 to a desired volume to be administered and in the event that the two are equal , the controller 22 controls the driver 18 to cease delivery of the fluid to the delivery device 12 . the volume detector 26 may take different forms , one of which is a monitor of the movement of the driver 18 . where certain positions of the driver 18 are correlated with certain volumes of fluid expelled from the reservoir 14 , the amount of fluid delivered can be determined from the position of the driver 18 . additionally , the volume detector 26 may also determine the end - of - travel position of the driver 18 and upon reaching that position , output a signal to the controller 22 which in turn may then automatically control the driver 18 to cease delivery of the fluid . an embodiment of an alternate end - of - travel arrangement is discussed in greater detail below . in accordance with another aspect of fig1 the controller 22 compares the pressure sensed by pressure sensor 20 to the volume of fluid delivered as detected by the volume detector 26 . in the event that the rate of fluid delivered remains the same but the pressure sensed decreases below a predetermined minimum , for example two atmospheres , and stays them for a selected period of time , for example two seconds , the controller 22 will provide a delivery alarm 28 . this delivery alarm 28 is intended to indicate a fluid delivery problem . in accordance with another feature of the invention , the controller 22 monitors the time of the delivery of the fluid from the reservoir 14 . upon receiving from the pressure sensor 20 an indication that the desired administration pressure has been reached , the controller 22 may then begin to time the administration of the fluid to the delivery site and upon reaching the time limit , provide a time alarm 30 and / or cause the driver 18 to cease delivery . for example , where a dilatation balloon is used for applying the fluid to the walls of a blood vessel , the predetermined time limit may be set at a safe period of blood flow interruption so as not to harm the patient , for example , ninety seconds . upon reaching that time limit , the controller 22 may automatically issue the time alarm 30 and automatically control the driver 18 to deflate the balloon . the controller 22 may also include a maximum pressure limit . in the event that the pressure exceeds that limit , the controller 22 will provide a pressure alarm 32 and immediately lower the pressure such as by controlling the driver 18 to cease operation . for example , a pressure limit of eight atmospheres may be input to the controller 22 . if the pressure of the fluid should exceed eight atmospheres , delivery would be immediately stopped and the pressure alarm 32 provided . the desired administration pressure , pressure alarm limit and time alarm limit may be set into the controller 22 via front panel controls 34 , a keyboard or other means . the front panel may also contain a switch for reverse drive 24 of the driver 18 to accomplish deflation of the delivery device 12 . referring now to fig2 a more derailed drawing of an embodiment of an automated fluid pressure control system 10 in accordance with the invention is presented . in this figure , the reservoir takes the form of a syringe 36 and the syringe plunger 38 operates to vary the volume of the syringe 36 by moving farther into or out of the syringe barrel . the syringe barrel is rigidly mounted by means of a mounting member 40 . a dilatation catheter 42 is connected to the output port 44 of the syringe and has a dilatation balloon 46 mounted at its distal end . the driver comprises in this case a slide mechanism 48 coupled to the syringe plunger 38 for moving the syringe plunger 38 in relation to the syringe barrel , an air cylinder 50 and an air controller 52 comprising a solenoid valve ( not shown ) and a control circuit ( not shown ). a pneumatic power source , in this case a source of air pressure , is supplied to the air controller 52 via an input line 54 . the air controller 52 receives the air pressure from the air pressure line 54 and controls that air pressure in accordance with the desired administration pressure set into the air controller 52 along electrical line 56 . in one embodiment , the air controller 52 comprises an electro - pneumatic regulator having the model designation of &# 34 ; qb &# 34 ; and manufactured by proportion - air , inc . of mccordsville , ind . this particular regulator incorporates a closed loop pressure control system where the pressure output of the regulator is sensed by a pressure transducer and is compared to the pressure signal set in the electronic control circuit of the regulator . in the event that a difference is sensed between the two pressures , the internal control circuit of the regulator changes the pressure output . the output pressure from the regulator is coupled to the air cylinder 50 which applies force against the syringe plunger 38 to move it relative to the syringe barrel thereby affecting the pressure of the fluid in the syringe . because of this direct physical link , the pressure sensed at the output of the regulator 52 is therefore indicative of the pressure of the fluid in the syringe 36 . the solenoid valve ( not shown ) of the air controller 52 may be switched to port the output air pressure from the regulator to one side or the other of the air cylinder to cause the syringe plunger 38 to either move farther into the syringe barrel or more farther out of the syringe barrel . a displacement detector 58 is also shown in fig2 and detects the position of the slide mechanism 48 . in this case , the displacement detector 58 comprises a linear resistor having a wiping contact connected to a linkage 60 which is connected to the slide mechanism 48 for moving the syringe plunger 38 . the wiping contact varies the voltage across the linear resistor 58 in dependence upon the position of the slide mechanism 48 . because the slide mechanism 48 is directly connected to the syringe plunger , the position of the slide mechanism 48 corresponds to the position of the syringe plunger 38 . thus , the amount of fluid provided from the syringe 36 can be determined by the voltage of the linear resistor 58 . the controller 62 of fig2 comprises two main parts , an interface unit 64 which comprises an analog - to - digital converter ( a - to - d converter ) and a digital - to - analog converter ( d - to - a converter ), a bus 63 , and a processor 66 . the processor 66 in this case comprises a micro - computer but may comprise other types of processors . the output signal of the linear resistor 58 is analog in form and is provided to the interface unit 64 for conversion to a digital signal before forwarding it on to the processor 66 . the desired delivery pressure of the syringe fluid is input in the processor 66 through the keyboard 68 in this case . the processor 66 provides a digital output signal representative of the pressure which is converted to an analog signal by the interface unit 64 . that analog pressure signal is provided to the electro - pneumatic regulator 52 to control the air cylinder 50 and the slide mechanism 48 . in this embodiment , the pressure controller would include the main controller 62 which provides the control signal for the desired pressure and also the pressure controller which is built into the qb electro - pneumatic regulator . an a - to - d converter found usable is the dascon - 1 , from metabyte , inc . which is a twelve - bit converter , although other converters may be used . a displacement detector which may be used is the lt - 103 from waters manufacturing . referring now to fig2 and 3 , an embodiment of a method of automated fluid pressure control is presented . the syringe size is input 70 and either a full stroke delivery or a measured volume delivery is selected 72 . the desired administration pressure p input , the delivery volume v input , and the maximum time of inflation t input are entered 74 , although a default time value such as ninety seconds may be used . the processor 66 converts 76 the delivery pressure p input to the pressure to be provided by the regulator 52 p reg . the processor 66 also converts 78 the delivery volume v input to plunger travel distance d input according to the syringe size . next , the air cylinder 50 is vented 80 , the solenoid activated 82 and the syringe and slide mechanism 48 are manually aligned 84 with the syringe plunger 38 being engaged . the delivery sequence is initiated 86 and the starting voltage from the linear resistor 58 is read 88 as the zero travel distance . the timer is started 90 and the pressure p reg to be maintained by the regulator 52 is sent to the regulator . the travel distance &# 34 ; d &# 34 ; of the slide mechanism 48 and the time &# 34 ; t &# 34 ; are continually monitored 94 and 96 and when either d = d input or t = t input , the timer is stopped 98 and the cylinder retracted 100 for removal or further disposition of the catheter 42 . in an alternate embodiment , the volume of fluid to be administered may be entered by means of a cassette identifier . entry of the cassette identifier will inform the processor 66 of the end - of - travel position for that particular cassette and may also include the maximum pressure p max permitted with that cassette . this information may be provided by means of a bar code placed on the cassette which may be read by a bar code reader ( not shown ) attached to the processor 66 . use of the term &# 34 ; cassette &# 34 ; is not meant to be limiting . the cassette referred to may take the form of a syringe or other device which performs the function of a fluid reservoir . a look - up table containing information corresponding to each of the possible cassettes usable in the system may be included with the processor 66 . referring now to fig4 a second embodiment of an automated fluid pressure control system is presented . as in fig2 a fluid reservoir comprising a syringe 36 and a pneumatic driver for moving the syringe plunger 38 are used to control the pressure of the fluid in the syringe 36 . the fluid is forced out of the syringe 36 , into the catheter 42 and into the delivery device which , in this case , is an inflatable balloon 46 . however , the system of fig4 also includes a pressure sensor 102 for monitoring the pressure of the fluid . the pressure sensor 102 may take the form of a silicon piezo - resistor which is responsive to pressure within the fluid between the output port 44 of the syringe 36 and the catheter 42 . a commonly available pressure sensor is the mpx - 700d from motorola . the pressure sensed is provided to the interface unit 64 on line 104 for conversion to a digital signal and for forwarding to the processor 66 . additionally , a pressure display 106 is provided for monitoring the pressure of the fluid being delivered . the processor 66 compares the digital pressure signal to the desired administration pressure and outputs on the bus 63 an error signal . the interface unit 64 converts that digital error signal to an analog signal for forwarding to the air pressure controller 52 . however , in the embodiment where a pressure regulator is used such as the qb electro - pneumatic regulator which converts the input signal to a pressure , the error signal must be added to or subtracted from the desired pressure signal provided to the regulator . in this embodiment , there are two pressure controls . the pressure regulator 52 itself monitors its own output while the additional pressure sensor 102 mounted at the output of the syringe 36 also monitors pressure . a further feature incorporated in the system of fig4 is an air - in - line sensor 108 for detecting air bubbles . the output of the air - in - line sensor is transmitted on line 110 to the interface unit 64 for conversion to a digital signal and is then transmitted to the processor 66 . in the event that an air bubble of a particular size is detected , the processor 66 may stop delivery of the fluid by the pneumatic driver and provide an alarm . such air - in - line sensors are available from zevex , inc . in murray , utah . alarms , such as those for air - in - line and pressure , may be provided by a display 114 connected to the processor 66 and may also be given audibly . known techniques for increasing the accuracy of the volume detection of fluid delivered to the delivery device 46 may be employed . for example , slope , offset and scale factors may be stored and made available to the processor 66 for each displacement detector 58 used . different syringes or cassettes may be used with the system , each of which has a look - up table made available to the processor 66 . techniques other than look - up tables may be used such as interpolation between beginning - of - travel and end - of - travel points . the operator may be prompted for a cassette code and upon entering that code , the processor may then create a look - up table for that cassette based on characteristic data of the cassette previously stored . processing techniques for smoothing pneumatic driver 50 and 52 responses may be included in the processor 66 . for example , a classical proportional , integral , derivative control system may be used . referring now to fig4 and fig5 a and 5b , an embodiment of a method for automated fluid pressure control is presented . the syringe size is input 70 and either a full stroke delivery or a measured volume delivery is selected 72 . the desired administration pressure p input , the maximum pressure p max , the delivery volume v input , and the maximum time of inflation t input are entered 74 , although a default time value such as ninety seconds may be used . the processor 66 converts 76 the delivery pressure p input to the pressure to be provided by the regulator 52 p reg . the processor 66 also converts 78 the delivery volume v input , to plunger travel distance d input according to the syringe size . next , the air cylinder 50 is vented 80 , the solenoid activated 82 and the syringe and slide mechanism 48 are manually aligned 84 with the syringe plunger 38 being engaged . the delivery sequence is initiated 86 and the starting voltage from the linear resistor 58 is read 88 as the zero travel distance . the timer is started 90 and the pressure p reg to be maintained by the regulator 52 is sent to the regulator at 92 . in other embodiments , the timer may be automatically started upon reaching a predetermined minimum pressure , as measured by the pressure sensor 102 ; for example , two atmospheres . the fluid line is monitored 114 for the existence of air and if an unacceptably high amount of air is detected , an alarm is provided 116 . the delivery pressure is continuously monitored 118 and if that pressure equals or exceeds p max 120 , an alarm is provided 116 . if the delivery pressure is not equal to p input 122 , the delivery pressure is increased or decreased 124 until p input is reached . the travel distance of the slide mechanism 48 is continually monitored 94 and 96 and when either the distance traveled &# 34 ; d &# 34 ; equals d input or the time expired &# 34 ; t &# 34 ; equals t input , the timer is stopped 98 and the cylinder retracted 100 for removal or further disposition of the catheter 42 . an end - of - travel determination of the syringe plunger may be made in the above embodiments . in one technique , the end of travel displacement may be programmed into the processor 66 as a characteristic of each cassette used . this data may reside in a look - up table in the processor or be input to the processor 66 in other ways . in another technique , the displacement sensor may be monitored for change and in the event that no further change occurs , the end of travel of the syringe plunger may be assumed . in the case of fig3 and 5 where step 72 requires a selection of full stroke delivery or measured volume delivery , the full stroke delivery may be determined by end of travel . additionally , a higher initial pressure may be programmed into the processor 66 for starting the fluid delivery . this initial pressure would be greater than p input and would cause rapid inflation of the delivery device so that a minimum loss of inflation fluid occurs . after inflating , the pressure would then be reduced to p input . a pneumatic power source typically available in most hospital rooms is the 100 psi air provided at a wall fitting . a connecting hose 54 may be coupled between the wall fitting and the air pressure controller 52 to provide a pneumatic energy source for the air cylinder 50 . the use of pneumatic power rather than electrical power to pressurize the delivery fluid reduces the electrical hazard to the patient . it was found that a pneumatic system provided the needed ramp - up speed to quickly inflate the balloon with the fluid to be administered while allowing losing only an insignificant amount of the fluid to enter the bloodstream during inflation . other driver systems may be used , such as a motor system using a stepper motor . however , it was also found that a pneumatic system offered a cost effective system which may be contained in a relatively small and light weight case . pneumatic energy is readily available in most hospital rooms ; hence , no portable source of power , such as an air cylinder , need be included in one embodiment . in another embodiment where air pressure is not available from the room , a portable air cylinder may be used . the embodiment using pneumatic power provides a rapid response and accurate control . in the case where a stepper motor is used to provide the driving means , a more complex , heavier and more expensive system may result because of the addition of the stepper motor itself . additionally , the driver 18 may take forms other than a volume controller of the reservoir 14 . a device which draws the fluid from the reservoir without varying the volume of the reservoir may be used . the systems and methods described above may be used with an angioplasty catheter to accurately control the pressure of the inflated balloon , although the air - in - line sensor 108 and the displacement detector 58 would have limited value . additionally , the systems and methods of the figs . are not limited to applications involving only the blood vessels . they may be used in procedures with organs such as the kidney , the liver ; and used in other procedures such as with the prostate and in other ducts . although specific embodiments of the invention have been described and illustrated , it is clear that the invention is susceptible to numerous modifications and embodiments within the ability of those skilled in the art , and without the exercise of the inventive faculty . thus , it should be understood that various changes in form , detail and application of the present invention may be made without departing from the spirit and scope of the invention .

US-92306392-A

a material collection parking system having a hopper connected to a rear discharge chute from a mower deck on a lawn tractor . the system includes a pair of front and a pair of rear parking support legs , at least one of the pairs of legs being independently moveable between a stowed position along a side wall of the hopper and a deployed position supporting the hopper on a ground surface . the material collection system has a low dump configuration and a high dump configuration providing unobstructed sight lines and rear visibility for the operator during rear collection in the stowed position on the lawn tractor .

fig1 - 3 show a first embodiment of material collection parking system 100 having a low dump configuration . the material collection parking system may include hopper 102 that may be attached to and removed from lawn tractor 104 having operator seat 105 . the lawn tractor may include discharge chute 106 that extends rearwardly from mower deck 108 into hopper 102 . in a first embodiment , material collection parking system 100 may include lift cylinder 124 connected to hydraulic hoses 126 and actuated by operator controls . a forward end of the lift cylinder may be pivotably attached to support 125 . support 125 may be removably attached to rear bracket 114 that may be bolted or welded to a rear frame portion of the lawn tractor . a rearward end of the lift cylinder may be pivotably attached to upper frame member 130 at the top front of the hopper . the controls may be used to extend the lift cylinder to dump the hopper , and to retract the lift cylinder to move the hopper back into the stowed position for grass collection . in a first embodiment , material collection parking system 100 may include front panel 132 mounted with hinges 134 to the top front of the hopper . discharge chute 106 may extend into an opening in the front panel . left and right lower pins or transverse rods 136 may be provided at a lower portion of the front panel , and the rods may be captured in left and right j - shaped slots 116 on a lower portion of the rear bracket . each j - shaped slot may have a rear facing portion 118 and a vertical portion 120 . to secure the front panel of the hopper to the lawn tractor in the stowed position , the lawn tractor may back up until the rods are in the rear facing portion of j - shaped slots 116 , and then the hopper may be lowered until the rods are at the bottom of the vertical portion 120 of the j - shaped slots 116 . additionally , the front panel may be secured to the lawn tractor in the stowed position by left and right upper pins 140 inserted through left and right holes 122 through an upper part of the rear bracket , and left and right holes 127 provided in support 125 attached to the front end of the lift cylinder . as shown in fig7 - 8 , a first embodiment of material collection parking system 100 may include left and right front parking support legs 142 and left and right rear parking support legs 144 attached to the hopper . the front and rear parking support legs may be pivoted 180 degrees between a stowed position against the hopper &# 39 ; s left and right side walls , and a deployed position extending down from the hopper side walls to the ground surface . the front and rear parking support legs may be mounted to the hopper side walls with hinge brackets 146 , 148 . each front leg may be held in the stowed position of fig7 by inserting pin 150 in hole 152 in the front leg and upper holes in the hinge bracket . each front leg may be held in the deployed position of fig8 by inserting pin 150 in hole 152 in the front leg and lower holes in the hinge bracket . each rear leg may be held in the stowed position of fig7 by inserting pin 160 in hole 162 in the rear leg and upper holes in the hinge bracket . each rear leg may be held in the deployed position of fig8 by inserting pin 160 in hole 162 in the rear leg and lower holes in the hinge bracket . alternatively , the parking support legs may slide between a stowed position and a deployed position . in a first embodiment , material collection parking system 100 may be moved between a stowed position in a low dump configuration on a lawn tractor as shown in fig1 , and a deployed position off the lawn tractor as shown in fig3 . first , lift cylinder 124 may be extended to open and pivot hopper 102 away from front panel 132 in the dump position . with the hopper in the dump position , pins 150 , 152 may be removed from the front and rear parking support legs . the front and rear parking support legs may be pivoted 180 degrees away from the hopper side walls , and the pins may be reinserted . the lift cylinder then may be retracted to pivot and lower the hopper back towards the front panel until rear parking support legs 144 contact the ground surface . upper pins 140 then may be removed from holes 122 in the upper part of the rear bracket and holes 138 in support 125 . lift cylinder 124 then may be extended to move the hopper away from the front panel until the front parking support legs contact the ground surface , as shown in fig2 . the lift cylinder then may be extended until lower pins 136 are raised from the bottom to the upper end of the vertical portion 120 of the j - shaped slots . the operator then may drive the lawn tractor forward to remove pins 136 out through the rear facing portion 118 of the j - shaped slots . the lift cylinder then may be retracted to close the panel , and the hydraulic hoses then may be disconnected . fig4 - 6 show a second embodiment of material collection parking system 200 having a high dump configuration . the material collection system may include hopper 202 that may be attached to and removed from lawn tractor 204 . the lawn tractor may include discharge chute 206 that extends rearwardly from mower deck 208 into hopper 202 . in a second embodiment , material collection parking system 200 may include left and right masts 214 behind operator seat 205 , left and right boom arms 218 pivotably attached to the masts at vertical locations below the top of operator seat 205 , and left and right lift cylinders 220 interconnecting between the masts and boom arms . a single boom arm 218 on each side of the hopper may have a first or upper end pivotably mounted to a bracket 216 near the top of a mast . each boom arm may be generally l - shaped with a downward bend angle , between about 90 degrees and about 135 degrees , where the boom arm extends rearwardly along the hopper side wall and supports the hopper . in the stowed position , the second or lower end of each boom arm may have a generally vertical or near vertical orientation adjacent the hopper sidewall near the underside of the hopper . in a second embodiment , a first end of each lift cylinder 220 may be pivotably mounted to bracket 216 on mast 214 below boom arm 218 , and a second end of the lift cylinder may be pivotably mounted to bracket 222 on an intermediate portion of the boom arm . the lift cylinders are attached to hydraulic hoses 224 and may be actuated by operator controls to extend the lift cylinders and raise the boom arms and hopper for dumping , or to retract the lift cylinders and lower the boom arms and hopper into the stowed position for grass collection . during grass collection , the masts 214 and l - shaped boom arms 218 are below the top of operator seat 205 , providing unobstructed sight lines and good rear visibility for the operator . in a second embodiment , material collection parking system 200 may include left and right lower pins or transverse rods 236 at a lower front portion of the hopper near the lower ends of masts 214 . the rods may be captured in left and right j - shaped slots 226 on a lower portion of rear bracket 213 on the frame of the lawn tractor . each j - shaped slot may have a rear facing portion 228 and a vertical portion 230 . to secure the hopper to the lawn tractor in the stowed position , the lawn tractor may back up until the rods are in the rear facing portion of j - shaped slots 226 , and then the hopper may be lowered until the rods are at the bottom of the vertical portion of the j - shaped slots . additionally , the hopper may be secured to the lawn tractor in the stowed position by left and right upper pins 240 inserted through left and right holes 241 through an upper part of rear bracket 213 , and left and right holes 232 provided in the hopper frame . as shown in fig9 - 10 , a second embodiment of material collection parking system 200 may include left and right front parking support legs 242 and left and right rear parking support legs 244 attached to the hopper . the rear parking support legs may slide up and down between a stowed position adjacent the hopper left and right side walls , and a deployed position extending down from the hopper side walls to the ground surface . the front parking support legs may be pivoted 90 degrees between a stowed position under the hopper floor , and a deployed position extending down from the hopper floor to the ground surface . in a second embodiment , the left and right front parking support legs 242 may be mounted under the hopper floor with brackets 246 and front leg supports 250 hinged to the front parking support legs . each front leg 242 may be held in the stowed position by inserting a pin in a first set of corresponding holes through front leg 242 , support 250 , and bracket 246 . each front leg 242 may be pivoted 90 degrees and may be held in the deployed position by inserting the pin in a second set of corresponding holes through front leg 242 , support 250 and bracket 246 . alternatively , the front parking support legs may be mounted to the hopper side walls . in a second embodiment , each rear leg 244 may be mounted to the hopper side wall with bracket 248 . each rear leg may be held in the stowed position by inserting pin 260 in hole 262 through rear leg 244 and a corresponding hole in the bracket . each rear leg 244 may slide downwardly and may be held in the deployed position by inserting pin 260 in hole 263 through rear leg 244 and a corresponding hole in the bracket . in a second embodiment , material collection parking system 200 may be moved between the stowed position on the rear of the lawn tractor for use during mowing , and the deployed position off the lawn tractor . in the stowed position , the top ends of the masts and boom arms are lower than the top of the operator seat to provide unobstructed rear sight lines for the operator . the left and right lift cylinders 220 may be extended to raise hopper 202 . with the hopper raised , pins 252 , 260 may be removed from the front and rear parking support legs . the operator may slide the rear parking support legs down to the deployed position , and may pivot the front parking support legs to the deployed position . the pins then may be reinserted . optionally , hydraulic controls may be used to extend dump cylinder 265 to tip the hopper back slightly ( preferably about 10 degrees ) before lowering the hopper . the lift cylinder then may be retracted to lower the hopper until front parking support legs 242 and rear parking support legs 244 contact the ground surface . when the hopper is supported by the support legs , upper pins 240 then may be removed from holes 241 in the upper part of the rear bracket and holes 232 in the upper part of the hopper frame . dump cylinder 265 than may be extended to raise the front of the hopper slightly , moving rods 236 upwardly in the vertical portion 230 of the j - shaped slots . the operator then may drive the lawn tractor forward far enough until rods 236 are out of the rear facing portion 228 of the j - shaped slots . the hydraulic controls then may be used to retract the lift cylinders 220 to lower masts 214 onto the ground surface , before the hydraulic hoses are disconnected . having described the preferred embodiment , it will become apparent that various modifications can be made without departing from the scope of the invention as defined in the accompanying claims .

US-201414199050-A

a step - in type overshoe composed of a molded plastic material which in its relaxed condition has a plurality of accordion - type pleats formed therein with their fold lines being generally horizontal . the overshoe has a flexible instep area arranged to be deformed upon receiving the toe of a shoe , together with a latching means for releasably compressing the rear end of the accordion - type pleats to permit seating of the shoe within the overshoe whereupon disengagement of the latching means returns the accordion - type pleats to their relaxed state embracing the foot of the wearer .

in fig1 reference numeral 10 indicates generally a step - in type overshoe of the present invention which is of molded construction and of pleated configuration . the material for the overshoe must be stiff enough to maintain its molded configuration in its relaxed state , but flexible enough to be deformed without being limp . suitable materials include vinyl polymers such as polyvinyl chloride or copolymers of polyvinyl chloride and polyvinyl acetate . another suitable rubber - like elastomer is an acrylonitrilebutadiene - styrene copolymer ( abs ). the invention is shown applied to a low - cut shoe in fig1 to 5 . this overshoe 10 includes a base portion 11 , a heel portion 12 , and an instep portion 13 . in accordance with the present invention , the sides and the back of the shoe are molded to provide accordion - type pleats 14 having their fold lines generally horizontal as best seen in fig2 . the accordion - type pleats 14 extend from one end of the instep area 13 around the back of the shoe and the heel portion 12 , to the opposite side of the flexible instep area 13 . the instep area 13 in the form of the invention shown in fig1 to 3 also includes accordion pleats 15 whose fold lines extend at an acute angle to the fold lines of the main accordion pleats 14 . the presence of the accordion pleats 15 in the instep area give the instep area flexibility so that when the street shoe s as shown in fig4 is placed into the overshoe , there is enough resiliency by virtue of the accordion pleats 15 to yield and accommodate some displacement as the shoe s is being placed inside the overshoe . a strap 16 depends from the upper end of the accordion pleated structure . it includes a slot 17 which is arranged to fit over an anchor such as a lug 18 located above the base of the shoe as illustrated in fig2 . when the toe of the conventional shoe s is being slipped into the overshoe , the strap 16 keeps the back end of the accordion pleats compressed as illustrated in fig4 so that the heel of the conventional shoe can be readily accommodated at the heel portion of the overshoe . then , after the toe and heel of the conventional shoe s are snugly received inside the overshoe , the strap 17 is simply disengaged from the lug 18 permitting the overshoe to return to its normal relaxed form shown in fig2 with the overshoe completely covering the conventional shoe s and protecting the same against rain and snow as well as providing a temperature barrier . the latch means shown in fig2 a includes simply a hook 43 integrally molded onto the top of the boot . the hook 43 is arranged to fit under the heel of the overshoe as shown in fig2 b , using complementary serrations 44 and 45 on the heel and hook , if necessary , to hold the hook against the heel . in this form , merely scuffing the heel of the overshoe against the floor is effective to release the engagement of the hook and permit the overshoe to achieve its extended position . in the form shown in fig4 and 5 , the latching means includes a strap 16 having an elongated keyhole type aperture 46 formed therein and a bent end portion 47 arranged to be received against the heel portion at the sole of the overshoe . sliding or scuffing movement of the end portion against the floor is effective to release the strap from the lug 18 , thereby allowing the pleats to rise to their extended position . flexibility in the instep area can also be achieved by the structure shown in fig6 of the drawings . in this form of the invention , the instep area is provided with a pair of upstanding flexible hollow wings 21 and 22 of generally triangular cross section . when the shoe is put into the instep area , the wings provide enough flexibility to accommodate movement between the street shoe and the overshoe until such time as the heel is seated in the overshoe . a slightly higher type shoe is illustrated in fig7 and 8 of the drawings . this type of shoe is arranged to provide some protection for the ankle of the wearer and above . the overshoe includes a base portion 23 , an instep portion 24 and a heel portion 25 . accordion pleats 26 having their fold lines generally horizontal provide an expansible upper section for the overshoe . the instep area also includes accordion pleats 27 as best seen in fig8 to provide the flexibility necessary in that area . the dashed lines in fig7 illustrate the folded condition of the accordion pleats , while the solid lines indicate the relaxed or extended position of the pleats . a strap 28 provided with a slot 29 is arranged to engage a lug 30 at the bottom of the overshoe as in a previous embodiment . in fig9 there is shown another embodiment of the invention , the overshoe shown in this figure including a base portion 33 , a heel portion 34 , and a shaft portion 35 extending up to the area of the wearer &# 39 ; s ankle . accordion - type pleats 36 having their fold lines substantially horizontal are provided in the lower portion of the shoe , and a strap 37 having a slot 38 is arranged to be received over a lug 39 as in the previously described embodiments . in the structure of fig9 two sets of accordion pleats 40 and 41 with their fold lines generally vertical are provided on opposite sides of the shaft portion 35 . the inner edges of the pleats may be rounded , if desired , to provide a more comfortable fit against the user &# 39 ; s leg . the instep area of the overshoe is made inherently flexible by a suitable choice of materials . the overshoe of fig9 is shown in its relaxed or free state , with the accordion - type pleats 36 holding the overshoe open for accommodating entry by the user &# 39 ; s shoe . from the foregoing it will be understood that the improved overshoe of the present invention provides a slip - on capability for applying overshoes over street shoes , making it easier for aged or infirm people to use the overshoe without outside assistance . it should be evident that various modifications can be made to the described embodiments without departing from the scope of the present invention .

US-53669683-A

a composition comprising a carboxamide compound represented by following formula , wherein r 1 represents a hydrogen atom or a methyl group , and r 2 represents a methyl group , a difluoromethyl group or a trifluoromethyl group , and abamectin is provided by the present invention , and this composition has an excellent pesticidal effect .

the pesticidal composition of the present invention ( hereinafter referred to as “ composition ”) comprises a carboxamide compound represented by formula ( i ): r 1 and r 2 represent the same meanings as defined in the above ( hereinafter referred to as “ carboxamide compound ”), and abamectin . the “ carboxamide compounds ” are those as described in , for example , wo86 / 02641 or wo92 / 12970 , and can be prepared by the method described therein . abamectin is a known compound and described in , for example , “ the pesticide manual — 14 th edition ( published by bcpc ) isbn 1901396142 . abamectin can be obtained from the products containing said compound ” in the market or can be synthesized by publicly known methods . the weight ratio of the “ carboxamide compound ” to abamectin in the “ composition ” is usually from 0 . 01 / 1 to 500 / 1 , and preferably from 0 . 01 / 1 to 4 / 1 of “ carboxamide compound ” to abamectin . although the “ composition ” may be a mixture itself of a “ carboxamide compound ” and abamectin , the “ composition ” is usually prepared by mixing a “ carboxamide compound ”, abamectin and an inert carrier , and if necessary , by adding a surfactant and / or another auxiliary for formulation and by formulating the mixture into oil formulation , emulsifiable concentrate , flowable formulation , wettable powder , water dispersible granules , powder , granules , or the like . the formulation , which is used alone or by adding another inert component , can be used as a pesticide . the total content of a “ carboxamide compound ” and abamectin in a “ composition ” is usually from 0 . 1 % to 99 % by weight , preferably from 0 . 2 % to 90 % by weight , and more preferably from 1 % to 80 % by weight . examples of the solid carriers used for the formulation include fine powder or granules of , for example , mineral materials such as kaolin clay , attapulgite , bentonite , montmorillonite , acid clay , pyrophillite , talc , diatomaceous earth and calcite ; natural organic materials such as corncob powder and walnut powder ; synthesized organic materials such as urea ; salts such as potassium carbonate and ammonium sulfate ; synthetic inorganic materials such as synthesized hydrous silicon oxide . examples of the liquid carriers include aromatic hydrocarbons such as xylene , alkylbenzene and methylnaphthalene ; alcohols such as 2 - propanol , ethylene glycol , propylene glycol and ethylene glycol mono - ethyl ether ; ketones such as acetone , cyclohexanone and isophorone ; vegetable oils such as soybean oil and cotton seed oil ; petrolic aliphatic hydrocarbons ; esters ; dimethylsulfoxide ; acetonitrile ; and water . examples of the surfactants include anionic surfactants such as alkyl sulfate ester salts , alkylarylsulfonate salts , dialkylsulfosuccinate salts , polyoxyethylene alkylaryl ether phosphoric acid ester salts , lignin sulfonate and naphthalene sulfonate formaldehyde polycondensed products ; non - ionic surfactants such as polyoxyethylene alkyl aryl ethers , polyoxyethylene alkyl polyoxypropylene block copolymers and sorbitan fatty acid esters ; and cationic surfactants such as alkyl trimethyl ammonium salts . examples of the other auxiliaries for formulation include water - soluble polymers such as polyvinyl alcohol and polyvinylpyrrolidone ; polysaccharides such as gum arabic , alginic acid and its salt , cmc ( carboxymethylcellulose ) and xanthan gum ; inorganic materials such as aluminum magnesium silicate and alumina sol ; preservatives ; coloring agents ;, and stabilizers such as pap ( acidic isopropyl phosphate ) and bht . the “ composition ” can be also prepared by formulating a “ carboxamide compound ” and abamectin according to the method as described in the above , and then making the formulations or their diluents . the “ composition ” can be used for protecting plants from damage by pest ( for example , arthropod pest such as insect pest and acarine pest , nematode pests such as nematoda , as well as plant disease ) which gives damage to the plant by feeding , sucking , or the like . examples of arthropod pest and nematode pests which can be controlled by the “ composition ” include the followings . hemiptera : planthoppers ( delphacidae ) such as small brown planthopper ( laodelphax striatellus ), brown rice planthopper ( nilaparvata lugens ) and white - backed rice planthopper ( sogatella furcifera ); leafhoppers ( deltocephalidae ) such as green rice leafhopper ( nephotettix cincticeps ), green rice leafhopper ( nephotettix virescens ); aphids ( aphididae ) such as cotton aphid ( aphis gossypii ), green peach aphid ( myzus persicae ), cabbage aphid ( brevicoryne brassicae ), potato aphid ( macrosiphum euphorbiae ), foxglove aphid ( aulacorthum solani ), oat bird - cherry aphid ( rhopalosiphum padi ), tropical citrus aphid ( toxoptera citricidus ); stink bugs ( pentatomidae ) such as green stink bug ( nezara antennata ), bean bug ( riptortus clavetus ), rice bug ( leptocorisa chinensis ), white spotted spined bug ( eysarcoris parvus ) and brown marmorated stink bug ( halyomorpha mista ), tarnished plant bug ( lygus lineolaris ); whiteflies ( aleyrodidae ) such as greenhouse whitefly ( trialeurodes vaporariorum ), silverleaf whitefly ( bemisia argentifolii ); scales ( coccidae ) such as calfornia red scale ( aonidiella aurantii ), san jose scale ( comstockaspis perniciosa ), citrus north scale ( unaspis citri ), red wax scale ( ceroplastes rubens ), cottonycushion scale ( icerya purchasi ); tingidae family ; psyllidae family ; and the like . lepidoptera : pyralid moths ( pyralidae ) such as rice stem borer ( chilo suppressalis ), yellow rice borer ( tryporyza incertulas ), rice leafroller ( cnaphalocrocis medinalis ), cotton leafroller ( notarcha derogate ), indian meal moth ( plodia interpunctella ), oriental corn borer ( ostrinia furnacalis ), cabbage webworm ( hellula undalis ) and bluegrass webworm ( pediasia teterrellus ); owlet moths ( noctuidae ) such as common cutworm ( spodoptera litura ), beet armyworm ( spodoptera exigua ), armyworm ( pseudaletia separate ), cabbage armyworm ( mamestra brassicae ), black cutworm ( agrotis ipsilon ), beet semi - looper ( plusia nigrisigna ), thoricoplusia spp ., heliothis spp ., and helicoverpa spp . ; white butterflies ( pieridae ) such as common white ( pieris rapae ); tortricid moths ( tortricidae ) such as adoxophyes spp ., oriental fruit moth ( grapholita molesta ), soybean pod borer ( leguminivora glycinivorella ), azuki bean podworm ( matsumuraeses azukivora ), summer fruit tortrix ( adoxophyes orana fasciata ), smaller tea tortrix ( adoxophyes honmai . ), oriental tea tortrix ( homona magnanima ), apple tortrix ( archips fuscocupreanus ) and codling moth ( cydia pomonella ); leafblotch miners ( gracillariidae ) such as tea leafroller ( caloptilia theivora ) and apple leafminer ( phyllonorycter ringoneella ); carposinidae such as peach fruit moth ( carposina niponensis ); lyonetiid moths ( lyonetiidae ) such as lyonetia spp . ; tussock moths ( lymantriidae ) such as lymantria spp . and euproctis spp . ; yponomeutid moths ( yponomeutidae ) such as diamondback moth ( plutella xylostella ); gelechiid moths ( gelechiidae ) such as pink bollworm ( pectinophora gossypiella ) and potato tuberworm ( phthorimaea operculella ); tiger moths and allies ( arctiidae ) such as fall webworm ( hyphantria cunea ); tineid moths ( tineidae ) such as casemaking clothes moth ( tinea translucens ) and webbing clothes moth ( tineola bisselliella ); and the like , thysanoptera : thrips ( thripidae ) such as western flower thrips ( frankliniella occidentalis ), melon thrips ( thrips parmi ), yellow tea thrips ( scirtothrips dorsalis ), onion thrips ( thrips tabaci ), flower thrips ( frankliniella intonsa ), tobacco thrips ( frankliniella fusca ); diptera : housefly ( musca domestica ), common mosquito ( culex pipiens pallens ), tabanus ( tabanus trigonus ), onion fly ( hylemya antiqua ), seed - corn fly ( hylemya platura ), chinese anopheles ( anopheles sinensis ), japanese leaf miner ( agromyza oryzae ), rice leafminer ( hydrellia griseola ), rice stem maggot ( chlorops oryzae ), melon fly ( dacus cucurbitae ), mediterranean fruit fly ( ceratitis capitata ) and liriomyza tritrifolii ; coleoptera : 28 - spotted ladybird ( epilachna vigintioctopunctata ), cucurbit leaf beetle ( aulacophora femoralis ), phyllotreta striolata , rice leaf beetle ( oulema oryzae ), rice plant weevil ( echinocnemus squameus ), rice water weevil ( lissorhoptrus oryzophilus ), boll weevil ( anthonomus grandis ), adzuki bean weevil ( callosobruchus chinensis ), zoysia billbug ( sphenophorus venatus ), japanese beetle ( popillia japonica ), cupreous chafer ( anomala cuprea ), corn rootworm families ( diabrotica spp . ), colorado potato beetle ( letinotarsa decemlineata ), beetle of family elateridae ( agriotes spp . ), tobacco beetle ( lasioderma serricorne ), anthrenus ( anthrenus verbasci ), rust - red flour beetle ( tribolium castaneum ), power post beetle ( lyctus brunneus ), white - spotted longicorn beetle ( anoplophora malasiaca ), common pine shoot beetle ( tomicus piniperda ), and the like ; orthoptera : grasshoppers ( locusta migratoria ), mole cricket ( gryllotalpa africana ), oxya yezoensis , oxya japonica , and the like ; hymenoptera : turnip sawfly ( athalia rosae ), leafcutter ant ( acromyrmex spp . ), fire ants ( solenopsis spp . ), and the like ; blattaria : german cockroach ( blattella germanica ), smokybrown cockroach ( periplaneta fuliginosa ), american cockroach ( periplaneta americana ), black mississippi cockroach ( periplaneta brunnea ), oriental cockroach ( blatta orientalis ); acarina : tetranychidae such as twospotted spider mite ( tetranychus urticae ), citrus red mite ( panonychus citri ) and oligonychus spp ., eriophyidae such as aculops pelekassi , tarsonemidae such as polyphagotarsonemus latus ; tenuipalpidae ; tuckerellidae ; acaridae such as tyrophagus putrescentiae , epidermoptidae such as dermatophagoides farinae , dermatophagoides ptrenyssnus , cheyletidae such as cheyletus eruditus , cheyletus malaccensis , cheyletus moorei , and the like . nematoda : pratylenchus coffeae , pratylenchus fallax , heterodera glycines , globodera rostochiensis , meloidogyne hapla , meloidogyne incognita , aphelenchoides besseyi , nothotylenchus acris , and the like . examples of the plant diseases which can be controlled by the “ composition ” include the followings . rice diseases : magnaporthe grisea , cochliobolus miyabeanus , rhizoctonia solani , gibberella fujikuroi ; wheat diseases : erysiphe graminis , fusarium graminearum , f . avenaceum , f . culmorum , microdochium nivale , puccinia striiformis , p . graminis , p . recondita , micronectriella nivale , typhula sp ., ustilago tritici , tilletia caries , pseudocercosporella herpotrichoides , mycosphaerella graminicola , stagonospora nodorum , pyrenophora tritici - repentis ; barley diseases : erysiphe graminis , fusarium graminearum , f . avenaceum , f . culmorum , microdochium nivale , puccinia striiformis , p . graminis , p . hordei , ustilago nuda , rhynchosporium secalis , pyrenophora teres , cochliobolus sativus , pyrenophora graminea , rhizoctonia solani ; maize diseases : ustilago maydis , cochliobolus heterostrophus , gloeocercospora sorghi , puccinia polysora , cercospora zeae - maydis , rhizoctonia solani ; citrus diseases : diaporthe citri , elsinoe fawcetti , penicillium digitatum , p . italicum , phytophthora parasitica , phytophthora citrophthora ; apple diseases : monilinia mali , valsa ceratosperma , podosphaera leucotricha , alternaria alternata apple pathotype , venturia inaequalis , colletotrichum acutatum , phytophtora cactorum ; pear diseases : venturia nashicola , v . pirina , alternaria alternata japanese pear pathotype , gymnosporangium haraeanum , phytophtora cactorum ; grape diseases : elsinoe ampelina , glomerella cingulata , uninula necator , phakopsora ampelopsidis , guignardia bidwellii , plasmopara viticola ; gourd diseases : colletotrichum lagenarium , sphaerotheca fuliginea , mycosphaerella melonis , fusarium oxysporum , pseudoperonospora cubensis , phytophthora sp ., pythium sp . ; brassicaceous vegetable diseases : alternaria japonica , cercosporella brassicae , plasmodiophora brassicae , peronospora parasitica ; soybean diseases : cercospora kikuchii , elsinoe glycines , diaporthe phaseolorum var . sojae , septoria glycines , cercospora sojina , phakopsora pachyrhizi , phytophthora sojae , rhizoctonia solani , corynespora casiicola , sclerotinia sclerotiorum ; potato diseases : alternaria solani , phytophthora infestans , phytophthora erythroseptica , spongospora subterranean , f . sp . subterranean ; tea diseases : exobasidium reticulatum , elsinoe leucospila , pestalotiopsis sp ., colletotrichum theae - sinensis ; tobacco diseases : alternaria longipes , erysiphe cichoracearum , colletotrichum tabacum , peronospora tabacina , phytophthora nicotianae ; diseases of chrysanthemum andasteraceae : bremia lactuca , septoria chrysanthemiindici , puccinia horiana ; diseases of various plants : pythium aphanidermatum , pythium debarianum , pythium graminicola , pythium irregulare , pythium ultimum , botrytis cinerea , sclerotinia sclerotiorum ; seed diseases or diseases in the initial stage of growth of various plants caused by aspergillus spp ., penicillium spp ., fusarium spp ., gibberella spp ., tricoderma spp ., thielaviopsis spp ., rhizopus spp ., mucor spp ., corticium spp ., rhoma spp ., rhizoctonia spp ., diplodia spp . , or the like ; virus diseases of various plants mediated by polymixa spp ., olpidium spp . or the like . examples of the plants for which the “ composition ” can be used are as follows : agricultural crops : maize , rice , wheat , barley , rye , oat , sorghum , cotton , soybean , peanut , buckwheat , sugar beet , rapeseed , sunflower , sugar cane , tobacco , and the like ; vegetables : solanaceous vegetables ( eggplant , tomato , green pepper , hot pepper , potato , etc . ), cucurbitaceous vegetables ( cucumber , pumpkin , zucchini , watermelon , melon , squash , etc . ); cruciferous vegetables ( radish , turnip , horseradish , kohlrabi , chinese cabbage , cabbage , brown mustard , broccoli , cauliflower , etc . ), asteraceous vegetables ( burdock , garland chrysanthemum , artichoke , lettuce , etc . ), liliaceous vegetables ( welsh onion , onion , garlic , asparagus , etc . ), umbelliferous vegetables ( carrot , parsley , celery , parsnip , etc . ), chenopodiaceous vegetables ( spinach , chard , etc . ), lamiaceous vegetables ( japanese basil , mint , basil , etc . ), strawberry , sweet potato , yam , aroid , and the like ; fruit trees : pome fruits ( apple , common pear , japanese pear , chinese quince , quince , etc . ), stone fruits ( peach , plum , nectarine , japanese plum , cherry , apricot , prune , etc . ), citrus ( mandarin , orange , lemon , lime , grapefruit , etc . ), nuts ( chestnut , walnut , hazel nut , almond , pistachio , cashew nut , macadamia nut , etc . ), berry fruits ( blueberry , cranberry , blackberry , raspberry , etc . ), grape , persimmon , olive , loquat , banana , coffee , date , coconut palm , and the like ; trees other than fruit trees : tea , mulberry , flowering trees , street trees ( ash tree , birch , dogwood , eucalyptus , ginkgo , lilac , maple tree , oak , poplar , cercis , chinese sweet gum , plane tree , zelkova , japanese arborvitae , fir tree , japanese hemlock , needle juniper , pine , spruce , yew ), and the like . the above - described plants may be those having resistance imparted by genetic engineering technique . among the above plants , the “ composition ” is expected to have excellent controlling effect particularly to plant disease caused in soybean . among the above plant diseases , soybean diseases to which especially excellent effect of the “ composition ” can be expected are rhizoctonia solani , cercospora kikuchii , septoria glycines , corynespora casiicola , phakopsora pachyrizi , sclerotinia sclerotiorum , cercospora sojina , and the like . a composition comprising “ carboxamide compound ( 1 )” and abamectin in which the weight ratio of “ carboxamide compound ( 1 )” to abamectin is 0 . 01 / 1 to 4 / 1 ; a composition comprising “ carboxamide compound ( 2 )” and abamectin in which the weight ratio of “ carboxamide compound ( 2 )” to abamectin is 0 . 01 / 1 to 4 / 1 ; a composition comprising “ carboxamide compound ( 3 )” and abamectin in which the weight ratio of “ carboxamide compound ( 3 )” to abamectin is 0 . 01 / 1 to 4 / 1 ; a composition comprising “ carboxamide compound ( 4 )” and abamectin in which the weight ratio of “ carboxamide compound ( 4 )” to abamectin is 0 . 01 / 1 to 4 / 1 ; a composition comprising “ carboxamide compound ( 5 )” and abamectin in which the weight ratio of “ carboxamide compound ( 5 )” to abamectin is 0 . 01 / 1 to 4 / 1 ; the method of controlling pest ( hereinafter referred to as “ controlling method ”) can be carried out by treating a plant or the soil where a plant grows with an effective amount of a “ carboxamide compound ” and abamectin . the part of plant to be treated is stem and leaf of a plant , seed or bulb of a plant , and the bulb means bulb , corm , rootstock , tuber , tuberous root and rhizophore . in the “ controlling method ”, the treatment of a plant or the soil where a plant grows with a “ carboxamide compound ” and abamectin can be carried out separately at the same timing , but the treatment is usually carried out by using a “ composition ” in light of convenience . in the “ controlling method ”, the treatment with a carboxamide compound ” and abamectin is , for example , stems and leaves application , soil application , roots application or seeds application . examples of the stems and leaves application include a treatment for surface of cultivated plant by a stem and leaves spray or a stem and tree spray . examples of the root application include a method of dipping a whole plant or the root of a plant into a liquid containing a “ carboxamide compound ” and abamectin and a method of sticking a solid preparation comprising a “ carboxamide compound ”, abamectin and a solid carrier onto the root of a plant . examples of the soil application include a method of spraying a “ composition ” onto a soil , a method of mixing a “ composition ” with a soil and a method of irrigating a “ composition ” into the soil . examples of the seed application include a method of treating seeds or bulbs of a plant to be protected from a plant disease with a “ composition ”. particularly , the application can be carried out by spraying a suspension of a “ composition ” to the surface of seeds or bulbs , or by spreading wettable powder , emulsifiable concentrate or flowable formulation itself or a mixture thereof with a small amount of water on the seeds or the bulbs , or by dipping the seeds into a solution of a “ composition ” for a prescribed time , by film coating application or pellet coating application . the amount of a “ carboxamide compound ” and abamectin used in the “ controlling method ” is different depending on the kind of a plant to be treated , the kind of a plant disease to be controlled and its frequency , the kind of a formulation , timing of treatment , method of treatment , place of treatment , weather condition , and the like . when a “ composition ” is applied to stems and / or leaves of a plant or to the soil where a plant grows , the total amount of a “ carboxamide compound ” and abamectin is usually from 1 g to 500 g / 1000 m 2 , preferably from 2 g to 200 g / 1000 m 2 and more preferably from 10 g to 100 g / 1000 m 2 . when a “ composition ” is applied to seeds of a plant , the total amount of a “ carboxamide compound ” and abamectin is usually from 0 . 001 g to 10 g / 1 kg of the seeds , and preferably from 0 . 01 g to 1 g / 1 kg of the seeds . an emulsifiable concentrate , wettable powder or flowable formulation is usually used by diluting the formulation with a small amount of water and spraying the diluted formulation . in this case , the concentration of a “ carboxamide compound ” and abamectin in total of the diluted formulation is usually from 0 . 0005 % to 2 % by weight and preferably from 0 . 005 % to 1 % by weight . a powder formulation or granule formulation and the like is usually used without dilution . the present invention is further explained in detail with formulation examples and test examples . however , the present invention is not limited by the following examples . in the following examples , “ part ” means “ part by weight ” unless otherwise provided . one of the “ carboxamide compound ” ( 1 ) to ( 5 ) ( 2 . 5 parts ), abamectin ( 1 . 25 parts ), polyoxyethylene styryl phenyl ether ( 14 parts ), calcium dodecylbenzene sulfonate ( 6 parts ) and xylene ( 76 . 25 parts ) are thoroughly mixed to give each of formulations , respectively . one of the “ carboxamide compound ” ( 1 ) to ( 5 ) ( 2 parts ), abamectin ( 8 parts ), a mixture of white carbon and polyoxyethylene alkyl ether sulfate ammonium salt ( weight ratio 1 : 1 ) ( 35 parts ) and water ( 55 parts ) are mixed and the mixture is milled by wet - milling method to give each of formulations , respectively . one of the “ carboxamide compound ” ( 1 ) to ( 5 ) ( 5 parts ), abamectin ( 10 parts ), sorbitan trioleate ( 1 . 5 parts ), and an aqueous solution ( 28 . 5 parts ) containing polyvinyl alcohol ( 2 parts ) are mixed and the mixture is milled by wet - milling method . an aqueous solution ( 45 parts ) containing xanthan gum ( 0 . 05 part ) and aluminum magnesium silicate ( 0 . 1 part ) is added to the milled mixture . to the mixture is added propylene glycol ( 10 parts ) and the resultant mixture is mixed by stirring to give each of formulations , respectively . one of the “ carboxamide compound ” ( 1 ) to ( 5 ) ( 1 part ), abamectin ( 4 parts ), synthesized hydrous silicon oxide ( 1 part ), calcium lignin sulfonate ( 3 parts ), bentonite ( 30 parts ) and kaolin clay ( 62 parts ) are thoroughly mixed and milled . water is added to the mixture and the mixture is sufficiently kneaded , granulated and then dried to give each of formulations , respectively . one of the “ carboxamide compound ” ( 1 ) to ( 5 ) ( 12 . 5 parts ), abamectin ( 37 . 5 parts ), calcium lignin sulfonate ( 3 parts ), sodium lauryl sulfate ( 2 parts ) and synthesized hydrous silicon oxide ( 45 parts ) are thoroughly mixed and milled to give each of formulations , respectively . one of the “ carboxamide compound ” ( 1 ) to ( 5 ) ( 3 parts ), abamectin ( 2 parts ), kaolin clay ( 85 parts ) and talc ( 10 parts ) are thoroughly mixed and milled to give each of formulations , respectively . test examples using each of the “ compositions ” are shown in the following . a cyclohexanone solution ( 100 microl ) containing prescribed amount ( weight ) of a test compound was applied on seeds of soybean ( variety : natto shoryu ) ( 10 g ) by using a rotary apparatus for seed treatment ( seed dresser , manufactured by hans - ulrich hege gmbh ). one day after the treatment , plastic pot was filled with soil contaminated by rhizoctonia solani , and the seeds treated with the test compounds were seeded in the soil and cultivated in a glass - greenhouse for 20 days ( hereinafter referred to as “ treated plot ”). thereafter , the presence of disease caused by rhizoctonia solani in the young plants which germinated from each seed was observed and disease severity was calculated according to the following calculation formula ( 1 ). on the other hand , seeds of soybean which were not treated as above were cultivated in the same way as above ( hereinafter referred to as “ non - treated plot ”) and the disease severity in “ non - treated plot ” was calculated in the same way as above “ treated plot ”. on the basis of the above disease severity in “ treated plot ” and “ non - treated plot ”, efficacy in “ treated plot ” was evaluated according to the following calculation formula ( 2 ). disease severity (%)=( number of infected young plants / total number of young plants )× 100 calculation formula ( 1 ):

US-201113643849-A

a tobacco pipe bowl wherein the interior burning chamber is larger at its bottom base than at its top where the bowl opening is located . furthermore , associated with the tobacco pipe bowl there is associated a honing tool to clean the tobacco pipe bowl .

fig1 shows a sectional perspective view of a restricted throat inverted ledge tobacco smoking pipe wherein the upper furnace area ( 1 ) and lower furnace area ( 3 ) define distinct areas wherein the outer perimeter of said furnace area are substantially parallel to the central vertical axis of the furnace . the drawhole ( 4 ) is laterally positioned on an edge of the flat furnace floor . as can be seen in the drawing furnace area ( 1 ) is separated from furnace area ( 3 ) by a 90 degree inverted ledge transitional junction ( 2 ). fig2 shows a sectional perspective view of a restricted throat , inverted ledge tobacco smoking pipe with multiple lower furnace areas wherein the upper furnace area ( 5 ) and first lower furnace area ( 7 ) is divided by the inverted ledge transitional junction ( 6 ), the second lower furnace area ( 9 ) is divided from the first lower furnace area ( 7 ) by the second inverted ledge transitional junction ( 8 ), and the third lower furnace area ( 11 ) is divided from the second lower furnace area ( 9 ) by the third inverted ledge transitional junction ( 10 ). the drawhole ( 4 ) is laterally positioned next to the flat furnace floor . fig3 shows a multiple lower furnace area restricted throat , inverted ledge tobacco smoking pipe wherein furnace areas 5 , 7 , and 11 correspond to furnace areas 5 , 7 , and 11 in fig2 . additionally , inverted ledge transitional junctions 6 and 8 correspond with inverted ledge transitional junctions 6 and 8 in fig2 . the drawhole ( 25 ), however , is centrally positioned on the flat floor ( 26 ) of the lowerst furnace area ( 11 ). fig4 shows a sectional perspective view of a restricted throat , inverted ledge tobacco smoking pipe wherein the furnace walls converge symmetrically upwardly about the central vertical axis of said furnace from said flat floor to said top . as can be seen by the drawing upper furnace area ( 12 ) is divided from the lower furnace area ( 14 ) by a transitional area ( 13 ) which is more gradual and of more than 90 degrees . the draw hole ( 4 ) is laterally positioned on the flat furnace floor . fig5 shows a sectional view of a honing tool for cutting a &# 34 ; restricted throat , inverted ledge tobacco smoking pipe &# 34 ;. the honing stone primary cutting area ( 18 ) is approximately three sixteenths of one inch wider than the secondary cutting area ( 17 ). the stone - holding arm ( 19 ) provides for flexibility , being of flexible metal , as well as providing stability for positioning of the stone . the pressure spring ( 20 ) provides for the necessary outward pressure being exerted on the cutting stones ( 18 ) during the cutting process . the junction ( 16 ) secures the stone - holding arms ( 19 ). the shank ( 15 ) is cylindrical . fig6 shows a hand reaming tool of pocket - knife like construction for cleaning a &# 34 ; restricted throat , inverted ledge tobacco smoking pipe &# 34 ; wherein the primary blade area ( 22 ) is approximately three eighths of an inch long and three sixteenths of one inch wider than the two inch long secondary blade area ( 21 ). the handle ( 23 ) also functions as a sheath . methods of manufacture include , but are not limited to , adding material to the upper portion of the bowl chamber by means of inserts , burning specially formulated material onto the upper wall , fitting or adhering other materials to the upper portion of the pipe &# 39 ; s interior wall , removing material from the lower portion of the bowl chamber by cutting , grinding , or burning , and the use of pre - manufactured capsules that conform in design to the concepts of the invention .

US-54520983-A

the present invention relates to a cranial radiography apparatus , particularly intended for dental panoramic radiography , said apparatus comprising a first body part to which is connected a second body part having thereto connected a third body part to which is connected a fourth body part . to the opposite ends of said fourth body part are connected an x - ray source and an x - ray detector . the body parts are connected to each other by means of pivot shafts aligned essentially parallel to each other . the pivot shafts are rotated by means of active actuators and their rotational movement is programmably controlled by means of a computer , thus permitting the x - ray source and the x - ray detector to be moved over any predetermined orbit . the apparatus further includes means for radiography using a cephalostat . the apparatus can be adapted for robotic change of the x - ray detector by virtue of said movements of the body parts of the apparatus and a storage post designed to store the x - ray detectors used in different radiography modes .

now referring to fig1 therein is shown the imaging geometry and the generation of the radiographic projections accomplished by means of a prior art apparatus . the x - ray source is denoted by reference numeral 10 and the loci of its tube focus in the different positions by reference symbols f 0 - f 6 . the x - ray source 10 emits an x - ray beam x through the teeth t and the jawbone l to an x - ray detector 20 along the line a . the path of the x - ray beam x is shown in fig1 for seven different positions a 0 - a 6 . the position of the x - ray source in its one limit position is denoted by reference numeral 10 ′ and , respectively , the x - ray detector by reference numeral 20 ′, whereby the corresponding position of the x - ray tube focus is denoted by reference symbol f 6 . the temporomandibular joints of the jawbone are denoted by reference symbol j . in the incisor region of the dental arch , covered by the angle formed between beams a 0 - a 2 ( sector c ) in the diagram , the rotation of the body part connecting the x - ray source 10 and the x - ray detector 20 occurs in a horizontal plane about a vertical axis of rotation o 2 . during the orbital movement from beam line a 2 to a 4 ( sector d ), the center of rotation o 2 moves dynamically along a curved trajectory ( not shown ) to position o 3 of the vertical axis of rotation as shown in the diagram , and therefrom farther away from the center axis a 0 ( c — c ). using the orbital geometry illustrated in fig1 the orthogonality of the panoramic exposure is realized with a good accuracy both for the incisor region of the dental arch and at the side regions thereof , even up to the temporomandibular joints j at the distal end of the jawbone l . also the magnification can be maintained constant over the entire imaged area by virtue of the fact that the distance b 0 - b 5 of the x - ray detector from the layer being imaged remains constant with a sufficiently good accuracy over the entire orbit of the exposure . in the following , a mechanism according to the invention is explained capable of realizing the above - described orbital geometry . in fig2 are shown the basic components of an apparatus according to the invention ; a pedestal 11 , a first body part 12 , a second body part 13 , a third body part 14 , a fourth body part 15 and a patient positioning support 16 . the first body part 12 may be fastened to the pedestal 11 , or alternatively , to a wall or ceiling . the first body part 12 most advantageously comprises a telescopic vertical arm with an adjustable height . alternatively , the first body part 12 may comprise a stationary upright bracket or similar body part suited for mounting on a wall or ceiling . in fig3 is illustrated in greater detail the second body part 13 , the third body part 14 and the fourth body part 15 , the latter having the x - ray source 10 connected to its one end and the x - ray recording device 20 to its other end . the x - ray recording device 20 may be a radiographic film , a ccd sensor or any other type of x - ray detector . the second body part 13 is connected by a vertical pivot shaft 24 to the first body part 12 , the third body part 14 is connected by a vertical pivot shaft 25 to the second body part 13 , and the fourth body part 15 is connected by a vertical pivot shaft 26 to third body part 14 . the invention may alternatively be implemented so that the first body part 12 is replaced by a wall and / or ceiling of the radiography room on which the second body part 13 is mounted directly by suitable fixtures and / or fastening means . in fig4 is shown a situation in which the pivot shafts 24 , 25 and 26 are provided with drive motors m ( cf . fig5 ) serving to provide robotic rotation of the body parts about their pivot shafts . to the shaft 24 is connected the drive motor 21 of the second body part 13 , to the shaft 25 the drive motor 22 of the third body part 14 and to the shaft 26 the drive motor 23 of the fourth body part 15 . alternatively , the apparatus may be implemented omitting the drive motor of the shaft 24 , whereby the pivot shafts 24 , 25 and 26 must be provided with essentially zero - play bearings , whose construction is known to be more cost - efficient and simpler than that of conventional linear guides and bearings . in fig5 is shown the block diagram of a driver control system for the drive motors 21 , 22 and 23 . with the help of a keyboard 31 , the required control data is entered into a central computing unit 32 that controls driver 33 of motor 21 , driver 34 of motor 22 and driver 35 of motor 23 . with the help of this control system , the body parts 13 , 14 and 15 can be moved so as to provide any desired orbital geometry for the movement of the fourth body part 15 . in panoramic tomography , the required orbital geometry can be implemented either so that the second body part 13 remains stationary , or alternatively , so that it participates in the generation of the orbital geometry , too . in fig6 a , 6 b and 6 c is illustrated an example of the different phases of a panoramic exposure in the case that the second body part 13 is stationary . herein , fig6 a shows the position of the body parts in the beginning of the exposure , fig6 b shows their position in the middle of the exposure and in fig6 c the position of the body parts is illustrated at the end of the exposure . the directions of rotation for the body parts are denoted by arrows in fig6 a , 6 b and 6 c . the drive motor 22 of the third body part , which is mounted on the second body part 13 , rotates slowly counterclockwise the shaft 25 which connects the second body part 13 to the third body part 14 . simultaneously , the drive motor 22 mounted on the third body part 14 rotates faster clockwise the pivot shaft connecting the third body part 14 to the fourth body part 15 . in fig7 a , 7 b and 7 c is illustrated an example of the different phases of a panoramic exposure in the case that also the second body part 13 participates in the generation of the orbital geometry . herein , fig7 a shows the position of the body parts in the beginning of the exposure , fig7 b in the middle of the exposure and in fig7 c the position of the body parts is illustrated at the end of the exposure . the directions of rotation for the body parts are denoted by arrows in fig7 a , 7 b and 7 c in the same fashion as in fig6 a , 6 b and 6 c . in the beginning of the exposure , the drive motor rotating the second body part is controlled to rotate clockwise ( cf . fig7 a ) the pivot shaft 24 connecting the first body part 12 to the second body part 13 , while after passing the mid - point of the exposure , the direction of rotation is changed counterclockwise ( cf . fig7 b ). the drive motor 22 of the third body part , which is mounted on the second body part 13 , rotates slowly counterclockwise the shaft 25 which connects the second body part 13 to the third body part 14 . simultaneously , the drive motor 22 mounted on the third body part 14 rotates faster clockwise the pivot shaft connecting the third body part 14 to the fourth body part 15 . the drive motors 21 , 22 and 23 are most advantageously stepping motors or similar pulse - controlled actuator devices . prior to starting the exposure , all moving body parts are turned aside thus providing an unobstructed access of the patient 17 to the positioning support 16 and allowing unhindered alignment of the patient 17 by the operating personnel into a correct position for the exposure . in fig8 the patient 17 is illustrated properly positioned . after the positioning of the patient 17 , the movable body parts of the apparatus are driven either robotically or manually into their initial positions for commencing the exposure as shown in fig9 . in fig1 a is shown in a side view the mutual disposition of the body parts 13 , 14 and 15 when they are controlled to their extreme limit positions . in fig1 b is shown the same situation viewed from above . as compared to conventional panoramic radiography equipment , the invention makes it possible to bring the x - ray source clearly farther away from the body of the radiographic apparatus , which offers improved capabilities in cephalometric radiography . in fig1 is shown the construction of an apparatus according to the invention modified for cephalometric exposures . herein , the apparatus is complemented with a cephalostat support arm 27 and an x - ray detector 28 suited for cephalography . in fig1 are shown in a top view the positions of the body parts 13 , 14 and 15 , as well as those of the cephalostat auxiliaries 27 and 28 . in fig1 is shown how an apparatus according to the invention can be placed compactly in a transport case thus minimizing its transport costs . in the configuration illustrated in the diagram , the first body part 12 of the apparatus comprises a telescoping column that is driven into its shortest possible length . the second body part 13 , the third body part 14 and the fourth body part 15 are shown articulated above one another into the space above the patient support 16 . the compact configuration of the apparatus illustrated in fig1 may also be utilized for storing away the apparatus in a store or a radiographic operating room . fig1 a shows the situation of fig1 from the side and fig1 b from above . in fig1 is shown an apparatus according to the invention in which the x - ray detector head of the fourth body part 15 is modified detachable and equipped with a mounting groove 47 for the x - ray detector . beside the apparatus is installed a storage post 44 with support means for changeable x - ray detectors . the storage post 44 of the radiographic recording means incorporates storage facilities for a number of different types of detectors . thus a suitable type of detector can be selected for any exposure situation and then the apparatus according to the invention carries out the selection by robotically fetching / mounting the detector . in fig1 , the storage post 44 is shown to carry , e . g ., uppermost a digital x - ray detector 45 with a radiographic film holder 46 below it . in fig1 the moving body parts 13 , 14 and 15 of the apparatus according to the invention are shown rotated into a position having the x - ray detector mounting head of the fourth body part 15 brought close to the storage post 44 . the first body part 12 of the apparatus is provided with a telescopic function for height adjustment . whereby the fourth body part 15 is brought level with the radiographic film holder 46 . in this position the film holder 46 can be attached to the fourth body part 15 . in fig1 the radiographic film holder 46 is shown attached to the fourth body part 15 , opposite to the x - ray source 10 so that the apparatus according to the invention is set ready for a panoramic exposure . the film holder 46 is equipped with locking means compatible with the mounting groove 47 . obviously , any other type of mounting means can be used . in fig1 the moving body parts 13 , 14 and 15 of the apparatus according to the invention are shown rotated into a position in which the detector mounting head of the fourth body part 15 is brought close to the storage post 44 and the fourth body part 15 is brought level with the digital x - ray detector 45 . in this position the x - ray detector 45 can be attached to the fourth body part 15 . in fig1 the digital x - ray detector 45 is shown attached to the fourth body part 15 , opposite to the x - ray source 10 so that the apparatus according to the invention is set ready for a panoramic exposure . the digital x - ray detector 45 is equipped with locking means compatible with the mounting groove 47 . obviously , any other type of mounting means can be used . in fig2 is shown a situation in which the digital x - ray detector 45 is first fetched robotically from the storage post and then attached to the fourth body part 15 . next , the detector is taken robotically to the detector mounting head of the cephalostat support arm 27 and then attached to said cephalostat support arm 27 . obviously , any other type of radiographic recording means may be employed as the x - ray detector . in fig2 the apparatus according to the invention is shown ready for a cephalometric exposure . the situation of fig2 is otherwise similar to that of fig1 with the exception of the detachable and freely transferable x - ray detector . fig2 shows the situation of fig2 viewed from above , thus giving a good overview of the mutual disposition and distances of the different components in the apparatus according to the invention . in fig2 is shown an alternative embodiment of the apparatus according to the invention having the fourth body part 15 replaced by two separate l - arms 54 , 55 . the x - ray source 10 is herein connected to the l - arm 54 , while the other l - arm 55 carries the x - ray detector 20 . the other body part is replaced by two arms 52 , 53 operating in a superimposed disposition . this arrangement makes it possible to implement with the help of a simplified construction all the varied orbital geometries required in the different radiographic imaging modes . the embodiment illustrated in fig2 is shown an alternative arrangement of configuring the scara arms of the apparatus according to the invention . this configuration disposes with a separate arm for , e . g ., cephalometric exposures , inasmuch the arms can be taken sufficiently far apart from each other . herein , the body parts 52 and 53 are connected to the first body part 12 by means of a common vertically - aligned pivot shaft , and the body part 52 carries the body part 54 connected thereto , while the body part 53 carries the body part 55 connected thereto . the x - ray source 10 is moved orbitally by means of the body parts 52 and 54 , while the x - ray detector is moved orbitally by means of the body parts 53 and 55 . furthermore , the x - ray source 10 is adapted to rotate freely about the vertical axis in respect to the l - arm 54 , and respectively , also the x - ray detector 20 in regard to the l - arm 55 . the rotational movement of the x - ray source 10 and the x - ray detector 20 can be implemented with the help of active actuators , advantageously using stepping motors or the like pulse - controlled actuator devices . using this type of construction , the apparatus according to the invention can implement all the above - mentioned radiographic imaging modes without needing separate accessories for , e . g ., cephalography . in fig2 is shown the position of the arms during a cephalometric exposure . the body parts 52 and 54 are rotated almost to their extreme limit positions and , respectively , the body parts 53 and 55 are rotated in the opposite direction almost to their extreme limit positions . in this fashion , the x - ray source 10 and the x - ray detector 20 can be brought maximally apart from each other . the patient 17 is shown standing close to the x - ray detector 20 . in fig2 a and 25b the position of the scara arms is shown in an exemplifying manner for two different positions of a panoramic exposure . during both phases of the exposure , the body parts 52 and 53 can remain stationary in parallel to each other , while the body parts 54 and 55 generate the mutual orbital movement of the x - ray source 10 and the x - ray detector 20 as required for the panoramic imaging mode . in fig2 a , all the body parts of the arm systems are shown driven parallel to each other . in fig2 b , the body parts 54 and 55 are shown rotated into an almost orthogonal position in respect to the body parts 52 and 53 . the other positions of the radiographic projections are formed by the intermediate positions between these extreme positions . a corresponding orbital geometry for a radiographic projection may alternatively be realized by way of not steering the body parts 52 and 53 into a superimposed position , but rather , controlling their position over a predetermined orbit . simultaneously , the positions of the x - ray source 10 and the x - ray detector 20 must be rotated so as to keep them at all times facing each other in order to facilitate the recording of the transmitted x - ray beam . depending on the application , the above - described apparatus may be modified in varied ways within the scope of the inventive spirit of the present invention . in some embodiments of the invention , the other body part 13 may be attached to the first body part 12 in a fixed manner without using a pivot shaft . alternatively , the second body part 13 can be mounted directly and solidly on a wall and / or ceiling , thus disposing with the first body part 12 of the apparatus , which hereby is replaced by said mounting on the wall and / or ceiling and the mounting blocks and fastening means used as fixtures . in this modification of the apparatus , it is possible to realize the radiographic imaging mode described above in conjunction with fig6 a , 6 b and 6 c . however , the cephalostat construction shown in fig1 and 12 cannot be implemented in an apparatus according to this embodiment , not at least directly . finally , it must be noted that the apparatus according to the invention is shown in fig2 - 12 in its very schematic form and in practice there may be used a plurality of different accessories omitted from the drawings . when the x - ray detector 20 is a ccd sensor or the like , the apparatus naturally includes all the necessary electronics and display equipment capable of storing the radiographic image in a digital form and displaying the same on a screen , for instance . furthermore , the apparatus can be complemented with any conventional storage / display system of patient data and other information . to those versed in the art it obvious that the above - described preferred embodiment of the invention is nonlimiting to the scope and spirit of the invention that may be varied by their details in a plurality of ways .

US-50971400-A

a remote control system and apparatus enabling safely accessing the interior of a cotton compacting chamber and other regions of a cotton harvester , and also operating aspects of the compacting apparatus contained therein and thereabout , and which system is optionally operable for operating other aspects of the harvester , for inspection , maintenance and / or service , as well as other purposes . the system requires initial steps , including to safely neutralize or lock out operating systems of the harvester , then enables accessing designated interior locations of the compactor and the ability to operate systems therein , including aspects of the compacting apparatus .

referring now to the drawings , fig1 , 2 and 2 a , show a cotton harvester 10 including a cotton module builder 12 , and a remote tether control system 14 constructed and operable according to the teachings of the present invention in cooperation with an operator presence system of the harvester , to activate from a remote location , a sequence for opening an unloading door 16 of module builder 12 without activating a module builder tilting function ( fig4 ), and to operate module compactor apparatus 18 of builder 12 with door 16 open , to gain access to a module building chamber of builder 12 , and components of apparatus 18 therein , which can include an auger drive and mounting mechanism , as well as other components , for the purpose of inspection , maintenance , and service . cotton harvester 10 generally includes a plurality of cotton harvesting units 20 extending across the front end thereof operable for harvesting cotton from cotton plants in the well known manner . the harvested cotton is conveyed by air flows through a plurality of ducts 22 into an upper region 24 of module builder 12 . module builder 12 generally includes an interior cotton compacting chamber 26 in which the cotton ( not shown ) is collected and compacted by downward movement of compactor apparatus 18 , as denoted by arrow a in fig2 a . in fig1 , compactor apparatus 18 is illustrated in an elevated position within module builder 12 , and in fig2 and 2a , in a lowered position therein . compactor apparatus 18 is actuated at times during the cotton harvesting operation to distribute the cotton within chamber 26 and compact it against a floor 28 of module builder 12 , supported by a horizontal frame 30 . compactor apparatus 18 includes a compactor frame 32 disposed above floor 28 , including front and rear cross members 34 and 36 , each of which includes opposite end portions which protrude outwardly from chamber 26 through vertical slots 38 ( fig1 and 2 ) through sides 40 of module builder 12 adjacent the front and rear ends thereof . referring also to fig3 , which is a top view of compactor apparatus , cross members 34 and 36 are connected to and supported by exterior side structures 42 disposed externally of sides 40 of module builder 12 , respectively . interior ribs 44 extend between cross members 34 and 36 so as to be disposed within chamber 26 , and a plurality of augers 46 extend between the cross members between interior ribs 44 so as to be disposed within the central region of the compacting chamber . augers 46 are rotatably driven by an auger drive 48 , which can comprise , for instance , a mechanism of shafts and bevel gears rotatably driven by a motor such as a fluid or electric motor 50 , all located within rear cross member 36 . several access panels 52 are located on the rearwardly facing surface of cross member 36 , and can be removed for accessing drive 48 , for such purposes as inspection , maintenance and repair . motor 50 can be suitably powered , for instance , by a pump of harvester 10 , in the well - known manner . each exterior side structure 42 of compactor apparatus 18 is connected to and supported for vertical movement ( arrow a in fig2 a , and in the opposite direction ) by a compactor actuator 54 , which , in turn , is supported adjacent to the respective side 40 of module builder 12 , by a support frame 56 . each compactor actuator 54 preferably comprises a fluid cylinder , and the cylinders are simultaneously extendable for lowering side structures 42 , and simultaneously retractable for raising the structures 42 , for moving compactor apparatus 18 downwardly and upwardly , respectively , within compacting chamber 26 for distributing and compacting any cotton therein . pressurized fluid can be provided to actuators 54 by a suitable fluid source , for instance , a pump of harvester 10 , also in the well - known manner . referring also to fig4 , as a well - known practice , when a compacted body or module of cotton within chamber 26 is complete , and at other times , as desired or required , unloading door 16 is unfolded to an open position extending rearwardly in co - planar relation to floor 28 , and the front end of module builder 12 is raised relative to harvester 10 , to tilt module builder 12 as denoted by arrow b , for unloading the module . drag chains 58 , located on floor 28 and also on the upper surface of door 16 , are operated to convey a cotton module thereover and onto a surface therebelow . the tilting of module builder 12 and the opening of door 16 are preferably performed simultaneously as part of an unloading routine which is automatically performed . the unloading routine includes as an initial step , automatically operating the compactor actuators 54 to retract to raise compactor apparatus 18 to its uppermost position within chamber 26 . tilting is effected by a tilt actuator 60 which preferably comprises at least one fluid cylinder . the opening of door 16 is effected by a pair of primary door actuators 62 connected between frame 30 and opposite sides of a primary door segment 16 a of door 16 , and a pair of secondary door actuators 64 connected between the opposite sides of primary door segment 16 a and corresponding sides of a secondary door segment 16 b , although it should be recognized that alternative actuator arrangements could be used . door actuators 62 and 64 also preferably comprise fluid cylinders which receive pressurized fluid from a suitable fluid source on harvester 10 , the fluid cylinders being extended to open the door and retracted to close the door . here , it should be noted that for cotton module builder 12 illustrated , primary door segment 16 a , when closed , encloses the open rear end of the module builder , and secondary door segment 16 b is pivotally mounted to and located generally rearwardly of primary door segment 16 a so as to be unfoldable therefrom to form an elongate ramp therewith extending from floor 28 of the module builder ( when tilted ) to the ground or other surface located behind and below the module builder for the unloading of cotton modules over the ramp , although it should be recognized that the present invention as described more fully below , can be used with a variety of other door arrangements . referring also to fig5 and 5a , a basic diagram of aspects of a control system 66 of module builder 12 of harvester 10 , and a diagram including modifications to incorporate aspects of remote tether control system 14 of the invention , respectively , are shown . the aspects of system 66 , as illustrated in fig5 , are automatically operable for controlling the operation of compactor actuators 54 during the compacting routine , and the operation of tilt actuator 60 and door actuators 62 and 64 during the unloading routine , is shown . control system 66 includes a processor based controller 68 connected in operative control of a compactor raise solenoid 70 energizable for controlling a compactor control valve 138 for directing pressurized fluid flow from a pressurized fluid source 140 and along a fluid path 142 , to the lower end of compactor actuators 54 for effecting retraction thereof and thus raising of compactor frame 32 ; a compactor lower solenoid 72 energizable for controlling valve 138 for directing pressurized fluid flow to the upper ends of compactor actuators 54 for effecting extension thereof and thus the lowering of compactor frame 32 ; a door open solenoid 74 energizable for controlling a door control valve 144 for effecting pressurized fluid flow along a fluid path 142 to door actuators 62 and 64 for effecting extension thereof and thus opening of door 16 ; and a door close solenoid 76 energizable for controlling valve 144 for directing pressurized fluid flow along a fluid path 142 to door actuators 62 and 64 for effecting retraction thereof and thus the closing of door 16 . controller 68 is connected to solenoids 70 , 72 , 74 and 76 , by suitable conductive paths 78 , such as the wires of a wiring harness of harvester 10 , in the well - known manner . additionally , controller 68 is connected in operative control of a tilt solenoid 146 energizable for controlling a tilt control valve 148 for directing pressurized fluid along a fluid path 142 to a lower end of tilt actuator 60 , for tilting module builder 12 , at an appropriate time during the unloading routine . referring more particularly to fig5 a , control system 66 also interfaces over suitable conductive paths 78 with various other systems of harvester 10 , including an engine control 80 , a transmission control 82 , and a park brake 84 . still further , control system 66 interfaces with an operator presence system or ops , which includes an operator presence system service switch 86 and other components such as a seat switch ( not shown ), and which also interfaces with engine control 78 , transmission control 80 and park brake 82 . referring more particularly to fig1 and 2 , and additionally to fig6 , operator presence system service switch 86 is preferably located on an operator console 88 , located within an operator cab 90 of harvester 10 . console 88 additionally includes an unload / harvest switch 92 , which enables an operator to select an operating mode for module builder 12 . addressing unload / harvest switch 92 first , when an operator switches switch 92 to the harvest mode , controller 68 is automatically operable to alternatingly energize compactor raise and lower solenoids 70 and 72 , for moving compactor apparatus 18 as required for performing cotton compacting routines . this can be done periodically , or responsive to cotton levels in chamber 26 . controller 68 is also connected in operative control of auger solenoids ( not shown ) operable for controlling operation of auger drive 48 in the well - known manner , for rotating augers 46 for distributing the cotton as part of the compacting routines . when switch 92 is switched to the unload mode , controller 68 is automatically operable to move compactor apparatus to a raised position , then to operate door open solenoid 74 to open door 16 , and actuate tilt actuator 60 , for tilting module builder 12 to an unload position , as shown in fig4 . drag chains 58 will then be operated for unloading a cotton module from the module builder . turning to the ops , a common function of the ops when activated , is to disable the functions of the harvesting units 20 for service , maintenance and / or inspection , under certain prescribed conditions , here , when the transmission of the harvester is in neutral , the engine is at idle , the parking brake is engaged , and the operator leaves the seat for any reason . with the ops activated , the operator can operate ops service switch 86 to power a service connector 94 that is located in a service box on one of the harvesting units . referring also to fig7 , the operator can then connect a connector 96 of a tether control handle 98 , to service connector 94 , and using a switch 100 on handle 98 , manually operate the harvesting unit &# 39 ; s drive functions while standing on the ground next to the unit . a cord connecting tether control handle 98 to connector 96 is of sufficient length to enable the operator walk to each of harvesting units 20 , to allow the operator to inspect , perform maintenance , or service each or any of the harvesting units . as noted above , according to the invention , remote tether control system 14 is operable in cooperation with the ops , to activate from a remote location , a sequence for opening at least primary door segment 16 a of unloading door 16 of module builder 12 without tilting the module builder , to allow an operator to gain access to cotton compacting chamber 26 , and components of apparatus 18 therein , including auger drive 48 , as well as other components , for inspection , maintenance , and service . system 14 is also operable to enable the operator to operate compactor apparatus 18 to move it to a desired height within the chamber , for inspection , maintenance , and service . to provide these capabilities , system 14 preferably utilizes tether control handle 98 , in cooperation with the ops , to actuate from a remote location , at least door actuators 62 , as required , to open primary door segment 16 a to its fully open position , but without actuating tilt actuator 60 , such that module builder 12 remains in its harvest position on frame 30 , as shown in fig2 . preferred elements of system 14 include a service center station 104 , preferably located on the rear right side of frame 30 , as shown in fig8 . service center station 104 contains two connectors , each of which is adapted and configured for connection to connector 96 of tether control handle 98 thereto . the lower connector 106 is connected by conductive paths 78 to door open and close solenoids 74 and 76 and thus is configured as a door open / close connector , and the upper connector 108 is connected to compactor raise and lower solenoids and thus is configured as a module compactor raise / lower connector . the connectors also preferably have a removable dust cap or caps for protection from the environment . system 14 is configured so that to service the rear of the harvester as mentioned , the operator will first set the ops by placing the harvester &# 39 ; s transmission in neutral , placing the engine throttle at idle position , and engaging the parking brake . this immobilizes the harvester . the operator activates connector 106 of remote tether system 14 by placing ops service switch 86 in its on position , and unload / harvest switch 92 in its unload position . all this can be performed while the operator is seated in the cab . the operator can then exit the cab and proceed to service center station 104 , or another person can perform the next step , which is to connect connector 96 to lower connector 106 , which will enable controlling door 16 using tether control handle 98 . door 16 can now be opened to the position shown in fig2 , using handle 98 . as noted above , as part of the remote control tether system configuration , tilt actuator 60 is not connected to either lower connector 106 or upper connector 108 , so as to effectively be locked out , such that , unlike in the normal unload routine wherein module builder 12 is tilted , in this routine , this does not occur . instead , switch 110 and another switch 112 on handle 98 , are enabled by receiving power from a power source 114 of harvester 10 , via ops service switch 86 and suitable conductive paths 78 , so as to be operable to open and close primary door segment 16 a . door segment 16 a will be opened to extend in the rearward direction from module builder 12 in at least generally coplanar relation to floor 28 . since a cotton module is not to be unloaded , a continuous , flat ramp is not required , and secondary door segment 16 b can be suitably positioned in relation to door segment 16 a so as to extend downwardly to whatever surface is located therebelow , such as illustrated . for instance , solenoids 74 and 76 can be configured to operate both door actuators 62 and 64 , but to cease operation thereof when primary door segment 16 a is unfolded to its fully open position . this full opening of primary door segment 16 a is sufficient to allow an operator to gain access to the rear , open end of cotton compacting chamber 26 , by climbing up angled secondary door segment 16 b , or to climb directly onto open door segment 16 a using a stepladder or the like . remote tether system 14 additionally includes a lockout device 110 , the state of which must be changed to enable operation of compactor raise and lower solenoids 70 and 72 . preferably lockout device 110 only allows operation of solenoids 70 and 72 when primary door segment 16 a is in its fully open position ( fig2 ). this is preferably achieved using a limit switch 116 , disposed on a door stop 118 of frame 30 and positioned to be abutted by a triangular brace 120 on door segment 16 a when that door segment is fully open . limit switch 116 is preferably configured so as to be in an open state when door segment 16 a is in any position other than the fully open position , and to be in a closed state when door segment 16 a is fully closed . limit switch 116 is connected by a suitable conductive path 78 to power source 114 , and to a relay 120 of lockout device 110 , so as to direct power from power source 114 to the relay when switch 116 is in the closed state . relay 120 is energized by the power directed thereto through switch 116 , and is also connected to power source 114 through ops service switch 86 , such that , when energized , relay 120 will direct the power received through switch 86 to upper connector 108 via a suitable conductive path 78 connected therebetween . tether control handle 98 can then be disconnected from lower connector 106 such that door 16 will remain in the position shown in fig2 , and handle 98 can now be connected to upper connector 108 , to disable operation of door solenoids 74 and 76 , and enable operation of compactor raise and lower solenoids 70 and 72 using switches 100 and 112 . for convenience , this can be done while the operator or other person is standing on the ground next to service center station 104 , and tether control handle 98 can be placed on primary door segment 16 a so as to be within reach when the operator climbs onto that surface . now , the operator , while standing on door segment 16 a , or at another location , can operate switches 100 and 112 on handle 98 , to move compactor apparatus 18 to a desired position , such as that shown in fig2 a . with compactor apparatus 18 positioned as desired , the operator can gain access to auger drive 48 by removing access panels 52 as required , for inspection , maintenance , and service . the operator can also further lower , or raise compactor apparatus 18 as desired . for instance , the operator may wish to raise the compactor apparatus in order to enter chamber 26 to inspect and / or service augers 46 and other components located in the chamber , and / or clean the interior , such as by removing accumulated linters and the like . after the above inspection and / or service has been completed , the operator can depress switch 112 to raise compactor apparatus 18 , or leave it in a lowered position . this is because when unload / harvest switch 92 is later switched from the unloading position to the harvest position , the compactor will automatically move where it needs to be for that particular mode . at this point , if the operator has completed the needed work in the interior of module builder 12 , and can climb down from open primary door segment 16 a . tether control handle 98 can then be disconnected from connector 108 and reconnected with connector 106 , and be operated to close door 16 , to render harvester 10 ready to resume harvesting operation . also referring to fig9 , a high level flow diagram 122 including steps of a representative embodiment of a method of the invention for initiating operation of the remote control tether system , is shown . as illustrated in decision blocks 124 , 126 , and 128 , certain conditions must be met , here , the transmission of harvester 10 must be in neutral , the engine must be at idle , and the park brake must be on . and , as denoted by block 130 , and as explained above , ops service switch 86 must be turned on , and unload / harvest switch 92 must be in the unload position , to activate the remote control tether system . at this time , remote control of operation of door 16 is enabled , as denoted at block 132 . as denoted in decision block 134 and block 136 , remote control of compactor operation is only enabled when the door is fully open . actual operation of the compactor is only effected when handle 98 is connected to the appropriate connector , as explained above . it will be understood that changes in the details , materials , steps , and arrangements of parts which have been described and illustrated to explain the nature of the invention will occur to and may be made by those skilled in the art upon a reading of this disclosure within the principles and scope of the invention . the foregoing description illustrates the preferred embodiment of the invention ; however , concepts , as based upon the description , may be employed in other embodiments without departing from the scope of the invention . accordingly , the following claims are intended to protect the invention broadly as well as in the specific form shown .

US-82587507-A

a dilitation balloon catheter with an inelastic balloon disposed in a streamlined configuration having a smaller deflated cross - sectional profile than any catheter hereto available and yet a potentially larger inflation caliber than prior art &# 34 ; low profile &# 34 ; catheters . during introduction across a region of stenosis , the balloon is wrapped around a guidewire in such a way that the guidewire contained therein can move freely . the wrapped configuration is maintained by means of a temporary bond . inflation of the balloon , following proper positioning of the catheter results in disruption of the aforementioned bond , permitting a balloon to unwrap from the guidewire contained therein .

although it is acknowledged at the outset that the configuration of the catheter described herein has application to the performance of a variety of dilitation procedures including peripheral angioplasty , valvuloplasty and dilitation of ureteral stenosis . for the purpose of clarity , the balance of the text will be confined to a discussion of the application of this device to the performance of percutaneous transluminal coronary angioplasty . fig3 a , 3b and 3c are a longitudinal sectional , top and end view , respectively , of the cutaway angioplasty dilitation balloon catheter of a preferred embodiment of my invention . an inset has been provided for the purpose of orientation with respect to fig3 a . a guidewire has been included in fig3 a and 3e for orientation . as shown in fig3 the catheter includes a housing 21 extending from a proximal end ( not shown ) to a distal end 22 creating a lumen 23 to accommodate an intracoronary guidewire 30 . the balloon typically is formed from an inelastic material so it will inflate uniformly to a predetermined configuration . fig3 b illustrates the housing 21 , communicating channels 45 , and balloon 40 from above . the balloon is shown in an unwrapped deflated condition . fig3 b also illustrates an optional feature of the catheter , specifically , a stiffening element 44 disposed longitudinally along the length of the balloon to provide additional column strength to the balloon . fig3 c is a &# 34 ; phantom &# 34 ; end view of the catheter illustrating the disposition of channels 45 within the confines of the catheter housing . the communicating channels 45 provide a means for both flushing air out of the catheter prior to introduction into the body as well as inflating the dilitation balloon 40 once the catheter has been positioned across a region of stenosis . fig3 d is a perspective view of the dilitation balloon 40 , in an unwrapped deflated condition and optional stiffening element 44 . for clarity , guidewire 30 is not shown in fig3 d . fig3 e is a perspective view of the dilitation balloon 40 and guidewire 30 illustrating the manner in which the dilitation balloon may be wrapped around the guidewire . relative to prior art catheters , this configuration permits the disposition of a relatively large inelastic balloon along the course of a guidewire with a minimal cross - sectional profile . ( the guidewire is shown larger than to scale for illustration .) typically , the balloon will be wrapped around the guidewire at the time of manufacture and will not be unwrapped until it is inflated within the region of the stenosis . both the lumen 23 in housing 20 and the lumen created by wrapping balloon 40 are of sufficient caliber to permit unimpaired longitudinal and rotational movement of guidewire 30 within the confines of the catheter . notwithstanding the small insertion diameter , on inflation , the balloon unwraps from the guidewire and provides the full capability of existing angioplasty dilitation balloons . a slot 26 at the end of the housing 21 allows the balloon to be inflated near the end of housing 21 without unduly stressing the guidewire 30 . the configuration of the balloon 40 can be modified to optimize the taper that develops along the leading edge of the catheter on wrapping the balloon around the guidewire as illustrated in fig3 e . because the balloons used in the construction of conventional catheters have very thin walls , the wrapping of a relatively large balloon around a guidewire does not lead to a significant increase in the overall deflated cross - sectional diameter of the catheter relative to the corresponding profile of a catheter containing a smaller caliber dilitation balloon . hence , this configuration of the preferred embodiment provides a catheter of lower deflated profile that contains a relatively larger balloon than prior art catheters . because the use of the catheter described herein permits the initial introduction of a balloon of optimal caliber within a severe stenosis with minimal resistance ( relative to conventional prior art low - profile catheters ), without the need to introduce and inflate several additional dilitation catheters across the region of stenosis the use of this system reduces the difficulty , expense , duration , and risk of the dilitation procedure . because the catheter readily accommodates 0 . 018 inch ( large caliber ) guidewires and exchange wires , the use of this catheter does not compromise directional control for miniaturization as do currently available low profile systems . furthermore , the catheter permits the maintenance of a previously installed exchange wire within the coronary artery following balloon dilitation in the event that the operator desires to maintain intraluminal access , an option not feasible with the hartzler system . for all of these reasons , the use of my catheter enhances the safety , feasibility , efficiency and economy of an intraluminal dilitation procedure . to provide additional column strength to manipulate the catheter across a tight stenosis , the lumen of the balloon may be made smaller than the guidewire lumen of the catheter housing . in this circumstance , a tapered guidewire allows the operator to manipulate the balloon across the stenosis by applying pressure to the guidewire itself . in this circumstance , the column strength of the guidewire contributes to the column strength of the catheter . on inflation of the balloon , the guidewire and catheter part . the addition of an optional stiffener 44 , as illustrated in fig3 a , 3b and 3d contributes to the column strength of the balloon . fig4 a - 4d illustrate the manner in which the wrapped balloon unwraps during inflation . when first manipulated across a stenosis , balloon 40 is wrapped in the manner of fig4 a . this configuration is maintained by a temporary bond designed to tolerate the stresses usually applied to this segment of the catheter during introduction across a coronary stenosis and yet release when subjected to the forces that develop during inflation of the balloon . this bonding may be achieved using any well known technique including , for example , ultrasonic bonding . as shown in fig4 b and 4c , as the balloon is progressively inflated by fluid inserted through the channels , the bond ( or bonds ) breaks , allowing the balloon to unwrap from the guidewire 30 . once it is completely unwrapped , as shown in fig4 d , the guidewire is no longer encompassed by the balloon . in an alternate embodiment shown in fig4 e , a stint 48 is used to maintain the balloon 40 in a wrapped position . when the balloon 40 is inflated , the stint 48 is deformed to an enlarged shape and remains within the artery to hold the lumen open . thus , the catheter functions as an optimal device to introduce stints into the vasculature . fig5 a , 5b and 5c illustrate three different embodiments for the design of the housing 20 of the catheter . in fig5 a , the guidewire 30 is shown together with a full length housing 21 and balloon 40 . an adapter 50 is shown attached to the catheter to communicate with channel 45 to enable flushing the air out of the channel and inflation of the balloon . in fig5 b the housing 21 extends only along a fraction of the length of the catheter . in one embodiment the housing and dilitation balloon extend about 25 centimeters back from the distal aspect of the catheter . this embodiment offers two advantages relative to conventional catheters . first , it eliminates the need for exchange wires which tend to be particularly cumbersome . second , this embodiment allows for extracorporeal fixation of the intracoronary guidewire during manipulation of the catheter within the heart because both extracorporeal elements are independent . fixation of the guidewire minimizes motion of the wire within the coronary artery as the angioplasty dilitation balloon catheter is advanced within the heart and thus minimizes some of the intra - arterial trauma that develops as a result of the inadvertent guidewire movement . this embodiment also eliminates the need for a second angiographer to stabilize the guidewire during this aspect of an angioplasty . in the embodiment of fig5 c the only aspect of the catheter that encompasses the guidewire is the balloon itself . the midportion of the catheter of this embodiment simply consists of one or more adjacent or coaxially disposed channels 45 extending from the flush / infusion fitting 50 to the balloon 40 . although the least stable configuration of the three , this embodiment affords the smallest caliber for the angioplasty dilitation balloon catheter . this permits the introduction of this catheter within a guiding catheter of proportionately smaller caliber . the use of a smaller guiding catheter allows the performance of a smaller arteriotomy , permitting the performance of a percutaneous dilitation procedure with minimal risk for peripheral vascular complications and hemorrhage . this design also permits complete separation of the catheter from the guidewire , following inflation of the balloon , substantially minimizing the likelihood of dislodging the guidewire during subsequent withdrawal of the deflated dilitation catheter . the catheter system of my invention offers several advantages over both the hartzler system and conventional low profile catheter systems . the deflated cross - sectional profile of my catheter is substantially smaller than the corresponding profile of all currently available catheter systems . by eliminating the tubing that constitutes the housing for the guidewire within the confines of the balloon at the distal aspect of the catheter , a considerable amount of the bulk that contributes to the deflated cross - sectional profile of the catheter is eliminated . also eliminated is the need to attach the deflated ( and hence planar ) balloon to the circumference of the tubing , a geometrical incongruity that frequently leads to the development of wrinkles . the wrinkles contribute to the deflated cross - sectional profile of all currently available low profile angioplasty dilitation balloon catheters . the wrapped configuration provides a means of disposing a dilitation balloon of larger caliber when inflated than corresponding prior art low profile catheters . this feature allows an operator , using this device , to introduce a dilitation balloon , of optimal ( inflated ) caliber , across a stenosis at the outset , with relative facility , without resorting to the installation and inflation of additional dilitation balloon catheters of sequentially larger caliber . by reducing the length of the guidewire housing , the need to use long and frequently cumbersome exchange wires , the installation of which requires the participation of two operators , is eliminated . it should be recognized that an exchange wire is simply a guidewire that is twice the length of a regular intracoronary guidewire . the additional length the wire is used during the exchange of conventional prior art dilitation catheters . thus , the wire must extend from the heart to the distal aspect of an angioplasty dilitation catheter when the catheter has been fully removed from the body . fig6 a illustrates in cross section a cover 60 adapted to fit over the wrapped balloon 40 and guidewire 30 . cover 60 protects the balloon 40 during shipment and facilitates preparation of the catheter by providing a cone - shaped surface 65 for threading the guidewire 30 into housing 21 . as will be described in conjunction with fig7 the cover also facilitates flushing of the catheter . fig6 b is a perspective view showing the cover 60 encompassing the balloon following introduction of the guidewire into the catheter lumen . the preparation of a conventional catheter involves the flushing of the system with renograffin - 76 , a conventional radiographic contrast agent diluted with normal saline . this flushing is to eliminate any air bubbles that might be trapped within the system . this procedure results in full inflation of the angioplasty dilitation balloon before it is ever introduced within the body . clearly , in the case of the catheter of my invention , this approach would be counterproductive because premature inflation of the balloon results in disruption of the bond which maintains the wrapped configuration of the balloon and unwraps the balloon itself from the guidewire . to avoid this , the catheter is distributed with a protective cover , similar to the protective cover 60 shown in fig7 a , in place . the housing prevents inflation of the balloon during the flushing procedure . because the balloon is tightly wrapped at the outset , it will not contain air . hence , to adequately prepare the catheter described herein for introduction into the body , it remains necessary only to flush the air out of channel ( s ) 45 , and this can be accomplished by means of a venting system illustrated in fig7 a . cover 60 then is removed prior to insertion of the catheter . with respect to flushing of catheters in general , there exist three different approaches . preparation of systems that contain no venting system depend upon the brute force of the operator to generate a substantial vacuum within the system prior to the introduction of any fluid . preparation of these systems is frequently time consuming , awkward and invariably results in the introduction of some air into the system . low profile systems are commonly constructed without a venting system . a second approach to flushing involved the introduction of a venting tube ( contained within the dilitation catheter ) within the confines of the balloon to vent the system . once the catheter has been vented , the tube is withdrawn and closed . this approach is time - consuming and cumbersome . furthermore , the vent tube contributes to the cross - sectional profile of the catheter as well as the dead space of the system , once the catheter has been flushed . the third and clearly superior approach involves catheter that contains two lumens , in addition to the lumen for the guidewire . such a catheter is depicted in fig7 a and 7b . at the outset one of the lumens functions as a flush port and one functions as a vent port for the system . once the catheter has been flushed , the extracorporeal vent is eliminated and the vent port is converted to an additional flush port . this approach offers several advantages . the system provides a vent for the catheter , thus minimizing both the amount of air trapped in the system , as well as the amount of force required to prepare the system . the configuration does not entail any dead space . also , once the system has been flushed , both channels function to inflate and deflate the balloon . because the resistance incurred during the inflation and deflation of the dilitation balloon is proportional to the cross - sectional profile of the infusion channel ( s ), the use of two channels allows the operator to inflate and deflate the balloon more rapidly relative to a single channel ( and hence , smaller caliber ) flush port system . the partition 48 separating the flush channel from the vent channel does not extend the entire length of the flush / vent port . to flush the system , one need only insert a preshaped syringe into only the flush port and inject fluid . in this circumstance , the vent port is open to air . once the vent port has filled with fluid , the catheter is fully flushed . the preshaped syringe is removed and the catheter attached to a standard inflation device , typically a syringe . because the coupling of the inflation device does not extend deep within the lumen of the flush / vent port , both channels are exposed to hydrostatic pressure on inflation of the balloon and hence , both channels function as flush channels .

US-23906188-A

a system and method is presented that leverages independent innovation in entertainment content and graphics hardware . in this system and method , the current image generation run - time application is replaced with a new framework defining the connectivity , features , and behavior necessary to implement a graphics system . all this takes place in the context of a software platform utilizing a late - integration mechanism that dynamically integrates the various real - time components in a run - time application . ultimately displacing hardware as the central focus of development efforts , this software platform functionally is the graphics application , at least as viewed by the simulation host computer , database developers , and those responsible for visual system procurement and maintenance . an innovative software architecture , the graphical application platform is presented . the gap builds on image generator , workstation , and scene graph success by extending the concepts of platform and framework into the real - time graphics domain — bridging the gap between image generation concerns and contemporary hardware and software realities by decoupling content , hardware and applications . this new approach also provides technology to address emerging concerns related to the selection and acquisition processes in the context of new low - cost , high - performance graphics hardware .

a preferred embodiment of the present invention is now described with reference to the figures , where like reference numbers indicate identical or functionally similar elements . also in the figures , the left - most digit of each reference number corresponds to the figure in which the reference number is first used . while specific configurations and arrangements are discussed , it should be understood that this is done for illustrative purposes only . a person skilled in the relevant art will recognize that other configurations and arrangements can be used without departing from the spirit and scope of the invention . it will be apparent to a person skilled in the relevant art that this invention can also be employed in a variety of other devices and applications . the invention described in the following sections is based on the concepts of the software platform and the application framework . these ideas replace the current graphical application structure , framework , or libraries with a new framework defining the connectivity , features , and behavior necessary to implement an image generator . all this takes place in the context of a software platform utilizing an integration mechanism that dynamically integrates the various real - time components in a run - time application . a platform , as the term is used herein , is a complete environment for executing programs . the most common platform is an operating system along with its system - and language - related run - time libraries . applications like emacs , with low - level text management facilities tied together in a user - extendable manner by an internal lisp interpreter , are evolutionary ancestors of application - level platforms . to illuminate the differences between the approach of the invention and its precursors , web browsers can be used as an analogy . when packaged with scripting and programming extensions , modem web browsers represent a platform for executing web page “ programs .” browsers are also applications , and the distinction between application and platform is subtle and often overlooked . the application part provides functions related to networked paperless communication ( html browsing and editing , electronic mail , news reading , and so on ), a graphical user interface , and navigation assists , e . g ., links to favorite web sites . the platform part consists of mechanisms to load “ programs ” ( fetching of html , java , cgi scripts , etc . ), standardized semantics for the meaning of these programs , and a run - time “ engine ” that evaluates the programs written in html , java , and scripting languages . historically , browsers did not expose these two roles as separate aspects ; one could not make a web page , java applet , or cgi script to redefine or extend the browser &# 39 ; s gui or other built in features , nor could an external developer move the browser interface to a different html platform . what would change had browser developers designed for such capabilities ? they would have built a “ browser virtual machine ” ( bvm ) that could fetch and execute html , java , and script languages ; this would be the platform . everyone would run it , but few would know about it , because they would have built a “ browser application ” identical to previous web browsers but implemented in modules of code executable by the bvm ; this would be the application that end - users would see and all of the look - and - feel would be here . however , they would have built mutability into the bvm , so developers could reshape every aspect of the standard browser application , for example , to replace the “ gui module ” with one of their own , or extend the “ html module ” with new features . browser developers recognize these virtues and are moving to a platform - and - framework approach to web browsing able to serve as the basis for developing new applications that integrate html , javascript , and java . providing this ability to extend and replace modules requires that the application have a higher degree of flexibility and generality than is customary . a framework , according to the invention , can be thought of as this type of comprehensive but mutable application , rather than a construction set api from which to build applications . construction set . a sturdy tree , a box of lights , a box of ornaments , and no hooks . comes with instructions reading , “ go for it ,” and photos of beautiful trees . framework . the same tree with lights , hooks , and a few ornaments pre - installed . the hooks allow attachment of whatever additional decorations are made . existing lights and ornaments can also be removed . the framework allows independent developers to write modules relying on common concepts in exactly the same way , and it minimizes development because programming complexity is limited to the difference between the standard and new applications . the construction set approach always requires an effort proportional to the complexity of the resulting application . these synergies are the virtues of the framework : it converts new development projects into incremental efforts and encourages modules sharable with others . these notions , platform and framework , are central to the software technique , described herein , for developing portable , high - performance applications that access every bit of hardware differentiation . when translating these concepts from browsers to the real - time graphics domain , additional requirements not present in browsers must be handled , such as time , synchronization , concurrency , and load management , in order to implement a complete graphical application platform . the graphical application platform ( gap ) implements a platform for graphical application development . its breadth and extensibility allow implementation of advanced real - time graphics applications that are both efficient and portable . its three major sections are : kernel . the application real - time kernel , or ark , is an application - level real - time thread manager . it invokes blocks of logic according to a deterministic schedule listing the blocks to be executed by each of one or more ark threads running on each available cpu . a set of system infrastructure elements is also built into the ark . these elements dynamically load and unload components , monitor block execution , and assist in thread management , memory sharing , mutual exclusion , and synchronization . components . feature implementations are packaged as executable components that support a powerful negotiation - based resource allocation scheme . standard components implement concepts like display configuration and position extrapolation and other features amenable to system - specific tuning like morphing an object , advanced surface shading , direct i / o transfers , and universal texture , terrain , objects , and cultural features . components have portable implementations that are rewritten for specialized hardware through arrangements with hardware manufacturers . this structure and tuning scheme is the primary “ differentiated yet portable ” mechanism of the gap . through it , application developers focus on “ what ” and “ why ” and leave the “ how ” to the platform developers and allied hardware partners . connections . connections implement the flow of data between blocks , within or between the components . they effect one - way transport from an upstream block to a downstream block — they provide the “ plug board ” to change communication patterns — an essential task when inserting a new block or replacing an old one . consider , for example , a connection between one block that traverses a graph to extract potentially visible objects and another block that receives objects and draws them . it may be desirable to insert a new block , say one to reject anything with an on - screen projection smaller than a given size , between these two . doing so means deleting the connection between traverse - and - draw , and adding connections between traverse - and - reject and between reject - and - draw . the ark implements such run - time reconfiguration without recompilation through efficient concurrency - aware connection facilities . the gap also provides a framework for graphical application development . a complete graphics application can be provided , one that developers can use directly or modify and extend as desired . by providing a standard application , a common naming and structure framework is established for derived applications , housing the mix - and - match flexibility in a concrete semantic context . although the design supports expansion to multiple cpus and multiple graphics devices , in practice this does not imply any overhead for smaller configurations . the idea is to provide a structure that is just more fully populated in advanced configurations . the framework application provides the common overarching structure for a broad class of graphical applications — a structure built of blocks that can be removed , replaced , and extended , and with connections between blocks that can be disconnected and reconnected , exposed and hidden . this allows a developer to reshape as much of the gap framework as deemed necessary to implement a custom application while leaving the system logically intact and , if desired , extensible by others . it also means that developers need only understand as much of the gap as they change . the application framework defines several phases , each of which corresponds to a potentially concurrent thread of execution . components are partitioned between these various framework phases . the gap architecture provides automatic detection of parallel access to data for correct pipelined execution . this feature provides independence from the hardware architecture while enabling transparent , yet efficient , parallelism at all levels of implementation . this gap capability can greatly reduce development time for complex , multi - threaded applications . gap features are organized in four groups , in an embodiment of the invention . the kernel ( ark ) provides access to hardware resources and public data structures . standard platform features implement tasks commonly used in applications . market - oriented features address concepts of particular domains . and application - specific features offer uniqueness to a particular application . application real - time kernel ( ark ). in an embodiment of the invention , this includes process management , threads of execution , and physical resources like processors , graphics pipelines , displays , texture memory , frame buffer memory , and system memory ; mutual access exclusion , explicit data sharing , and implicit data privacy ; high - precision counters , timers , and , time of day clocks ; asynchronous file - system operations and memory transfers ; and run - time component loading and unloading . standard platform features . in an embodiment of the invention , these features include input device management ; morphing , interpolation , deformation , and evaluation ; spatial audio processing ; activity logging and replay ; configuration file parsing and evaluation ; coordinate system processing , including precision management and articulation graphs ; and , paging of objects , textures , materials , and sounds . market - oriented features . in an embodiment of the invention , these are the standard concepts of an industry . for basic visual simulation , this includes a universe model supporting ephemeris time ; geo - referenced temporal positioning ; solar system object position and appearance ; visualization of the star - field and constellations ; height above terrain , line of sight intersection , multi - point terrain following , object intervisibility determination , and collision detection ; an atmospheric model with patchy layered fog , horizon haze , scud clouds , dynamic cloud volumes , and directional horizon glow ; special effects for rain , sleet , snow ; and many other features . application - specific features . in an embodiment of the invention , these elements extend or reshape the framework into a particular application . for example , this can include motion models , command line processing , environment variable processing , graphical user interface customization , and , application - specific database loading and decoding logic . together , the ark and standard features define the graphical application platform ( see fig5 ), which when combined with one or more market - oriented feature sets , defines a comprehensive development and deployment platform . gap - based developers use these features , those from market - oriented collections , and custom application - specific features to implement their applications . blocks are the basic elements of the gap framework , defining the “ atoms ” of interactive visual computing . they are the basic unit of execution within the gap and are end - points for input and output linkages . once built , blocks are bound into an application ( or to an encapsulating block ) by constructing connections between its input and output points and compatible points on other blocks . a block does not know the identity of the blocks that provide its input or that of blocks that connect to its output . data specified in the block interface definition allows the ark to implement this run - time dynamic connection facility for compiled blocks invisibly and efficiently . fig6 shows the internal structure of a generic block 600 according to an embodiment of the invention . block 600 contains the following elements : input connection points 605 . each such input point has a name and a type . names are used when making connections , both internally and externally . types may be compound data structures , in which case access can be to “ member of name ” in addition to the aggregate “ name .” output connection points 610 . each such output point has a name and a type . output points correspond to public state elements derived from intrinsic objects . access to these internal objects is provided to other blocks that are connected to the corresponding output points . internal state elements 615 . these elements include state information , i . e ., block instance data . executable content 620 . this includes standard functions , such as construct ( ), destruct ( ), and initialize ( ) to provide object lifetime services , and an evaluate ( ) function that implements the processing of the block . executable content 620 , output connection points 610 , and input connection points 605 can be viewed as components of the interface definition 625 of block 600 . in one example , most blocks are implemented in natively compiled and optimized assembler , c , and c ++ code . others , known as compound blocks , can be expressed purely by weaving simpler blocks together as a processing graph . these reticulations define links into and out of the block and linkages from the block &# 39 ; s input and output to and between internal blocks , and can be defined and implemented with simple scripts . connections link blocks together . they are essentially a means to specify the arguments for subroutine invocation through a general connection topology that allows changes to the connection topology after the functions have been compiled . a single connection can be established from each block input point to a compatible output point of any other block . many properties of connections are explained by visualizing them as one - way pipelines where data flows from an internal data member ( derived from an object ) through an output point of one block ( the producer ) downstream to an input point of another ( the consumer ). connections are created at run - time and can be made and broken during execution . for example , moving an eye point through a scene may cause the geometry - paging feature to load a new animation component along with newly paged geometry . the incoming animation block would need to be attached to the camera position and the connection would be made as described above . once connected , the camera position data is available to the newly loaded block when the internal accessor functions associated with the block &# 39 ; s input points are invoked . by maintaining this dataflow model irrespective of concurrency mode , the ark offers coherent access to data shared between concurrently executing blocks ; allows sporadic generation and consumption of data between blocks that operate synchronously at different rates or asynchronously ; and , offers temporal coherence for processing pipelines with several multi - megabyte frames of data being processed simultaneously . components are the highest - level objects in the gap environment . they are factories for generating new collections of blocks based on an iterative global resource allocation process that chooses between logically identical alternates that typically have very different physical realizations . components are designed to prudently answer questions of the following form at run - time : “ what should be added to the framework to insert a particular feature , given a specific hardware configuration and constraints on available resources ?” this question is difficult as it depends on both local and global information : locally , as seen in fig7 one of several available implementations ( 701 a through 701 n ) of a feature may be chosen based on constraints , such as the availability of hardware or other resources . globally , one implementation may be preferred over another in order to avoid overuse of a critical resource or to optimize based on application preferences , such as image quality or rendering rate . as shown in fig8 each alternate implementation , e . g ., alternate implementation 701 a , has a list of resources 805 , such as system memory , texture memory , cpu requirements , and data - transfer bandwidths that are required to successfully instantiate the particular implementation and information used to reduce these requirements when a resource negotiation is necessary and possibly expand the requirement when resources are abundant . components may also introduce new resources into the system . each alternate implementation includes a list of resources 810 provided by that alternate . new resources also have resource negotiation information , supporting supplier - side bargaining in subsequent negotiations over the new resource . after the components in an application have been identified , each is asked about its resource requirements ; the answer is the list of the alternate implementations and their required resources . aggregating these requirements specifies a run - time multidimensional resource allocation task . when a single solution exists , the chosen alternative is communicated to each component which then instantiates the corresponding implementation . links into and out of the component become links into and out of the blocks of that implementation . in an embodiment of the invention , when more than one combination of alternative implementations fits within resource constraints , then the chosen configuration is based on weighting parameters contained in the component definitions and evaluation equations provided by the application developer . this preferred solution is then communicated with the components which instantiate the chosen alternatives and link them into the framework . if resources are over - subscribed then there is no direct solution , and the system enters a negotiation phase in which each block is asked which of its resource requirements can be reduced and what the penalty would be for making such a trade - off . a typical example would be texture memory resources that could be reduced by one - fourth at the penalty of blurry images . another example would be system memory resources minimized by incremental paging rather than fully pre - loading data at the expense of extra cpu utilization and data transfer bandwidth consumption . this negotiation continues until an acceptable configuration is reached . the resource allocation process assures that no component &# 39 ; s implementation is instantiated unless all necessary resources are available and that an appropriate decision about which of several alternatives is chosen in response to available resources . [ 0117 ] fig9 illustrates the concept of phases of execution according to an embodiment of the invention . after resource negotiation is completed , the blocks comprising the application ( such as block 902 ) are distributed among the framework &# 39 ; s phases 905 through 925 ) as specified in the component definitions . this results in phase lists , such as list 930 , each containing zero or more blocks . for example , the database - paging phase list will be empty if an application does not include the standard database - paging component . each non - empty phase list defines a potentially concurrent phase of the application . [ 0118 ] fig1 shows how non - empty phases are mapped to stages of execution according to an embodiment of the invention . each execution stage represents a collection of phases that the ark will execute in a single thread . stage 1005 , for example , represents initialization phase 905 , geometry morphing phase 915 , and culling phase 920 . stage 1010 represents drawing phase 925 . the resulting stages of execution are prepared for execution by generating a deterministic execution order list . this list arranges the pair - wise block orderings ( imposed by connections ) into a total ordering of the blocks in the phase &# 39 ; s block list in an embodiment of the invention . this is shown in fig1 . the execution order list 1110 resulting from phase to stage processing is an input to the ark and evaluation of such lists is a primary ark activity . in the sequential execution environment a single ark thread , under the control of an ark thread manager 1105 , continuously iterates over the execution order list selecting and executing some or all of the blocks during each pass . the ark supports cases where some blocks run at different rates , as seen in fig1 . concurrency support within the ark handles ( 1 ) multiple threads on a single processor ( termed multi - threading or multi - programming ), ( 2 ) a single thread on each of multiple processors ( multi - processing ), and ( 3 ) arbitrary combinations of these modes . in concurrent execution , there are multiple ark threads t 1 through t n each with its own block execution order list ( eol ), as shown in fig1 . converting the flattened application graph into multiple lists will generally cause connections between some of the blocks to span an ark thread boundary , with the upstream and downstream blocks in different lists . this has significant implications for shared data , which is a case handled invisibly by the ark . both standard and user - developed gap features are designed and implemented as components , and as such , they enjoy an unusual degree of flexibility and potential impact : they can replace existing components , replace individual blocks within components , change existing connections , insert themselves between existing blocks , and define the areas of desirable concurrency with each of their alternate implementations . each of these tasks is performed openly by labeling the actions , impacts , and resource implications , as opposed to the anonymous “ tree decoration ” model of the scene graph . completeness in the gap extension model suggests that a given component can be added to many gap - based applications . components will negotiate for their needs , and the ark late - integration process will globally adjust the application based on the requirements of the newly inserted components while honoring the preferences defined in the application . consider the “ universal texture ” feature of the gap as an example of the extension process . the desire is to provide an application with texture images of enormous extent , such as a centimeter - resolution representation of the earth &# 39 ; s surface as a single 10 , 900 - terabyte - texture map . this technique has many practical advantages , including decoupling texture paging from geometric subdivision to afford the capability to use the same database on different hardware platforms . the universal texture component implements its task in a three step process : moving data from disk or across a network to main memory , moving data from main memory to graphics device texture memory , and using view information and the downloaded textures on a per - frame basis to implement the universal texture concept . the gap implementation separates these steps into several potentially concurrent phases , each with several blocks interconnected using ark connections , and all characterized based on resource requirements and preferences . the implementation uses highly efficient direct i / o for disk transfers , uses main - memory as a texture - cache that handles cache update complexities at the international date line and the poles , and redefines texture - processing details as needed to implement universal texture semantics . when this component is inserted into a gap - based application , it correctly provides the universal texture feature without requiring update or recompilation of other modules and does so across a range of graphics hardware . hardware vendors offering special features useful for implementing universal texture ( e . g ., evans & amp ; sutherland global texture unit , sgi clip - map hardware , sgi uma visual workstations , s3 texture compression modes , etc .) can replace the standard gap implementation with one that accesses differentiating features of the hardware . such vendor localizations define more than graphics ; they also specify concurrency models and application structure to suit their implementation based on issues like texture load latency and interactions with other components as resolved during negotiation . applications using the universal texture feature , such as an image of the earth as shown in fig1 , inherit vendor - specific tuning when they are executed , demonstrating how hardware developers can greatly increase the adoption rate of their new features since even previously released gap - based application software requires no modification or re - release to access the benefits of new hardware . the gap architecture brings a new implementation technology to the real - time visualization marketplace that separates vertical application - level features from their implementation environment . this separation expands the modularity of graphics and multimedia applications by untangling the previously intertwined tasks of application development , content development , and hardware development , as follows : decoupling of applications and content . the gap makes applications largely independent of content , since behavioral modules packaged with content by model builders can provide portable behavioral definitions . semantic bridges between modeling tools and the gap ensure that the personality displayed by active content within modeling tools matches that shown when the content is used in gap - based real - time software . decoupling of content and hardware . the gap environment separates content - level designs from hardware - level expressions of those decisions . its structure allows the development of content based on standard definitions of intent that are tuned to each hardware platform not by the content developer , but by the hardware vendor through porting and tuning of standard gap components . decoupling of hardware and applications . the gap removes the dependence of application developers on unique hardware characteristics , allowing application development for a “ virtual ” visualization platform rather than a particular hardware and operating system combination . conversely , the gap allows hardware vendors to integrate unique characteristics of their hardware into pre - existing applications , easing vendor concerns about attracting applications to their special hardware features . when the term “ platform ” is used herein , it means a self - contained environment for executing some type of program . the most common platform is an operating system along with its system - and language - related run - time libraries . applications like emacs , which provides low - level text management facilities tied together in a user - extendable manner by an internal lisp interpreter , are evolutionary ancestors of application - level platforms . the type of platform described herein is different from applications like emacs and traditional operating system platforms . to illuminate the differences and the motivations for these differences , consider platforms and frameworks in the web browser space where the concepts are self evident . in the javasoft java environment , the java virtual machine ( jvm ) is the platform for executing java byte - codes . combining the jvm with standard java classes in byte - code form creates a platform for java applications . in a similar sense , netscape and microsoft &# 39 ; s internet explorer both contain a platform for executing html . when packaged with scripting and programming extensions , these browsers represent a platform for executing web pages within the context of the browser application . in the operating system context , programs and shell scripts replace html pages and the operating system is the platform . browsers are also applications , but the distinction between application and platform is subtle . netscape the application provides functions related to networked paperless communication ( html browsing and editing , electronic mail , news reading , and so on ), a graphical user interface , and navigation assists like links to favorite web sites . the platform aspect of netscape consists of mechanisms to load “ programs ” ( e . g ., fetching of html , java , cgi scripts ), standardized semantics for the meaning of these programs , and a run - time “ engine ” that evaluates the programs written in html , java , and scripting languages . historically , netscape &# 39 ; s browser products did not expose these two roles as separate aspects ; one can &# 39 ; t make a web page , java applet , or cgi script that redefines or extends the browser &# 39 ; s gui or other “ built in ” features nor could a user move the navigator browser interface to a different html platform — but what if netscape had designed for that capability ? 1 . they would have built a “ browser virtual machine ” that could fetch and execute html , java , and script languages ; this would be the platform . everyone would run it , but few would know about it , because . . . 2 . they would have built a “ browser application ” that was identical in function to netscape navigator but implemented in modules of code executable by the bvm ; this would be the application that end - users would see and all of the look - and - feel would be here , except . . . 3 . they would have built an “ extend and replace ” capability into the bvm , so developers could reshape every aspect of the standard browser application , for example , to replace the “ gui module ” with one of their own , or extend the “ html module ” with new features . both netscape and microsoft recognize the importance of this approach . each has announced support for a platform and framework approach to web browsing that can serve as the basis for developing other applications that integrate html , javascript , and java . microsoft now provides a browser that can have its user interface replaced , accept plug - in modules that redefine standard features , and serve as a plug - in module to support html rendering within other applications . the design and structure of the competing platforms are quite different : netscape &# 39 ; s approach is to be a complete browser platform within an operating system independent application . they use the corba component - programming model and their corba implementation is written in java . microsoft &# 39 ; s internet explorer and the internet explorer application kit ( ieak ) relies on windows operating system services for key features in the fight to define their operating system as the platform for browsing . ieak uses the com component programming model and com - based activex components . sun &# 39 ; s java takes a third view , positioning a their programming language as the universal platform . they include operating system functionality in the language &# 39 ; s run - time environment and mandate every feature necessary for browsing ( awt , java2d , java3d , etc .) as inherently available elements in their interpreter . providing the ability to extend and replace modules requires that the application be built with a higher degree of flexibility and generality than is customary . an “ application framework ” is defined to be precisely this type of mutable application . note that the application framework is explicitly intended to be a complete application ( though perhaps with dormant capabilities ) that already does the general thing in a standard way , rather than a construction set from which an application could be built . the framework provides a structure so that independent development teams can write modules relying on common concepts in the same way . it also means that development is eased because programming complexity is limited to the difference between the standard application and the new application . when the standard application provides the majority of common features , then this difference is low . the construction set approach always requires a programming effort proportional to the complexity of the resulting application . these virtues define the synergy of the framework ; it converts new developments into incremental ones and encourages modules that can be shared with and licensed to others . when these concepts are translated from browsers to our real - time graphics world , it is a good match , although several demanding issues that are not part of the browser analogy must be handled . these issues include time , synchronization , concurrency , and performance management . the notions of platform and framework are the basis for the invention described herein , and enable portable , high - performance , media - rich applications that use the differentiation provided by hardware . the implementation of the platform and framework concepts described herein results in two major differences from other platforms . first , by designing for performance before compatibility , many of the complexities faced by the corba and com component interfaces , for example , are avoided . in particular , since each of these seeks domination over the other , they attempt to support each other &# 39 ; s components through a foreign - function interface : com - based applications like internet explorer can include corba components and corba - based applications like netscape can include com components . such compatibilities come at significant expense in terms of performance and complexity . here , no external compatibility is needed . the interface model can be structured to best fit application goals and the underlying implementation . secondly , multi - threading is supported as an intrinsic feature of the platform . the component interface is designed to be a partner ( along with an application - level real - time kernel ) in efficiently implementing invisible concurrency . this is in contrast to com and corba which are not thread - safe themselves unless serializing locks wrap each entry point and which leave concurrency issues to component builders . the gap implements a platform for graphical application development . some targeted applications are expressible within the facilities supported by the gap in combination with new capabilities that can be added to the gap by application developers in the form of extension modules called blocks . the “ platfornhood ” of the gap results from this structure : kernel . the application real - time kernel ( ark ), an application - level real - time thread manager . the ark invokes blocks according to a schedule listing the blocks to be executed by each of one or more ark threads running on each available cpu . a set of system infrastructure elements accompanies ( and in some cases is built into ) the ark . in an embodiment of the invention , these elements dynamically load and unload components , monitor block execution , and assist in tasks like thread management , memory sharing , mutual exclusion , and , synchronization . the ark provides a modular framework that can best be thought of as an efficient , configurable , real - time , performance - centric , graphics virtual machine definition and execution framework . the ark is designed to manage the flow of data and to schedule all of the processing of graphics processes . it is the smart glue that digests an application piece by piece , understanding the structure and intent , and then managing that intent efficiently and robustly in a real - time manner . although designed to be as thin and light as possible in an embodiment of the invention , the ark gets its power from an application definition semantic which corresponds to an efficient run - time implementation . the ark makes application definition ( including data flow and processing scheduling ) explicit and modular . it abstracts the interface between modular code segments with highly efficient data interfaces rather than slower functional interfaces , separating processing and data flow . it forces developers to explicitly define and relate each code module to the overall application machinery , allowing vertical feature development of components of the machine . these components can be developed quickly and independently with current programming methodologies ( such as c / c ++)— the ark has little or no direct influence over developer &# 39 ; s use of their standard programming methodologies . thus , the ark can defines , in effect , a new feature level driver model for the entire application . this new application driver model inherently provides automatic , re - configurable , multi - thread , multi - process , multi - buffer data management of single threaded code modules . the ark , although it manages all data that flows between system modules , can be data structure agnostic and will allow for and manage run - time extension of user - defined data structures even across multiple developers . in summary , the ark provides the ability to define an application from its code modules , data structures , and data flow , while providing everything necessary to act as an efficient run - time kernel enforcing definition - time semantics ( via control of data flow and module scheduling ). blocks . the ark operates in the context of blocks . the blocks are grouped into replaceable components supporting a novel and powerful negotiation - based interface definition . the term “ module ” is a general reference to the three types of blocks : super blocks that are a connected network of simple and compound blocks . components are special meta - blocks ; they deliver a collection of super blocks at the completion of a resource negotiation . in addition to system - related blocks , numerous standard feature - level components are provided with the gap . in an embodiment of the invention , these elements implement commonly used features ( e . g ., opening a window , interpolating a quaternion , broadcasting a position ), features that are amenable to system - specific tuning ( e . g ., morphing an object , bump - mapped surface shading , direct i / o transfer ), and features that can distinguish gap - based applications ( universal texture , terrain , objects , and culture ). the blocks themselves can be implemented portably in reference code , and are specially tuned for specific hardware through arrangement with hardware manufacturers . this structure and tuning scheme is the primary “ differentiated yet portable ” mechanism of the gap . connections . blocks are linked by one - way connections that represent the flow of data from the upstream block to the downstream block . connections are critical elements of the design as they provide a “ plug board ” to change communication patterns which is an essential task when inserting a new block or replacing an old one . consider , for example , a connection between a component that traverses a graph to extract potentially visible objects and a component that receives objects and then draws them . a developer may want to be able to insert a new component , say one to reject anything with an on - screen projection smaller than a given size , between these two . doing so means deleting the connection between traverse and draw and adding connections between traverse and reject , and between reject and draw . this can be supported without recompiling any blocks through the run - time connection facilities of the ark . natively compiled and optimized code ( assembler , c , c ++, etc .) can be supported as the primary implementation mode for block development . the native code approach limits portability compared to pure interpretation , but there can be a need for speed . blocks are portable to the degree of compiler compatibility so block developers may need conditional compilation or alternate implementations on different platforms . the gap support of natively compiled modules and language - independent interface definitions means that developers can use the skills and code they have already developed when building applications for the ark . some blocks can be expressed purely by weaving other blocks together into a processing graph . these types of blocks are called “ compound blocks ” as opposed to the “ simple blocks ” that perform processing . developing a connection - only block means defining links into and out of the block and the linkages from the block &# 39 ; s input and output to and between the internally instantiated blocks , which can be done through a scripting language or a lightweight connection parser . such reticulation blocks can be handled without the need for run - time block code by automatically collapsing each “ link - to - a - link ” into a single link , or equivalently by considering a compound block as a macro that is expanded before use . it may be desirable to implement a block using a scripting language when processing duties are light or infrequent . interpreted scripts provide guaranteed portability across gap implementations irrespective of compiler variations . the plan is to create a flexible scripting mechanism ( primarily handling non - deterministic actions like mark - and - sweep garbage collection and marshalling arguments into and out of the interpreter ) so that various languages can be supported by the same infrastructure . the gap also provides a framework for graphical application development . it is a graphics application that developers can use directly or else modify and extend as desired . this application can provide an interactive graphics viewer that can be distributed to end - users . application developers can reshape the application by adding custom blocks and replacing some of the standard ones before shipping their gap - based products . by providing a standard application , a common naming and structure framework is established for derived applications ; mix and match flexibility is then imbedded in a concrete context . conceptually , the framework application can be designed in the following manner . first , the class of applications that the gap is to address is considered . this includes graphics - rich games and interactive entertainment , traditional visual simulation , real - time applications in video and film production and on - air broadcast , and advanced geo - spatial information systems used in mission rehearsal ; hardware configurations ( e . g ., number of cpus and graphics pipelines ); and the windows 98 , windows nt , and unix - like ( irix , solaris , and linux ) operating systems . next , these applications are examined to find a general structure that could address the union of their needs . the resulting structure defines a unifying application framework , which must then be segmented into potentially concurrent phases of execution . key features within the framework are then expressed as standard components . the component definitions along with the blocks that comprise them define the standard blocks . exerting the effort to find a common substrate across application domains and levels of hardware sophistication means that the gap can provide a natural home for advanced features as they migrate to lower - cost , higher - volume platforms . although the design supports expansion to multiple cpus and multiple graphics devices , this does not imply overhead for smaller configurations . a structure can be provided that is more fully populated in advanced configurations . several important characteristics emerge during the design of the framework application that may be indicative of designing for the gap in general . here is a summary : the design can employ smart high - level data structures as buffers between data flows in various parts of the application , mostly in the form of smart caches where data are reused across a span of renderings . in block form , these structures have a small control interface and implicit internal processing . examples include the object graph , articulation graph , atlas and index maps , object , image , and audio caches , and , command and classification and bins . early processing components are generally asynchronous between both themselves and the back end , while the back end stages are simpler and run synchronously at the image computation rates . most connections are local to a phase . there are two major exceptions : linkage to some of the lower - level gap standard blocks occurs everywhere but seems easy with respect to concurrency , and a few linkages travel from near the front of the block graph to the near the end , short circuiting asynchronous execution and pipelining between the endpoints . as a framework , this application provides the common overarching structure for a broad class of graphical applications — a structure built of blocks that can be removed , replaced , and extended , and with connections between blocks that can be disconnected and reconnected , exposed and hidden . this allows a developer to reshape as much of the gap framework as necessary to implement an application while leaving the rest of the system intact and extensible by others . it also means that developers must only understand and touch as much of the gap as they need to change . this is illustrated in fig1 a and 14b . fig1 a shows graphics software 1415 using one or more of standard features 1420 , provided with the ark 1410 , to facilitating execution on either of multiple hardware platforms 1447 ( a sony playstation 2 ) and 1449 ( a personal computer ). in contrast , fig1 b shows graphics software 1455 using one or more of the features 1460 that are specific to the application , facilitating execution on either of multiple hardware platforms 1447 and 1449 . note that this flexibility is also available to hardware developers , as illustrated in fig1 a and 15b . in fig1 a , a developer of a hardware platform , e . g ., platform 1447 or 1449 , uses one or more of the standard features 1420 provided with the ark 1410 . this allows different software programs ( such as software 1505 and 1510 ) to execute on the given platform . [ 0179 ] fig1 b , in contrast , shows the case where the hardware developer uses , instead , one or more of the application - specific features 1525 , to allow different software programs ( such as 1515 and 1520 ) to execute on the given platform . [ 0180 ] fig1 illustrates the availability of different features that perform an analogous function . here , the function is that of shading . a generic shader 1605 is available as a standard feature . in addition , different shaders ( such as shaders 1610 a through 1610 d ) can also be developed as market - oriented features or application - specific features . different shaders can be better suited to different graphics software ( such as games 1640 and 1650 ). likewise , still other shaders can be employed for different hardware devices , e . g ., devices 1630 a and 1630 b . [ 0181 ] fig1 a and 17b illustrate the logical relationship between the ark 1705 , an application 1710 , and hardware platforms . fig1 a shows the relationship between ark 1705 , application 1710 , and hardware platform 1712 , a playstation 2 , in an embodiment of the invention . fig1 b shows the relationship between ark 1705 , application 1710 , and hardware platform 1752 , a personal computer , in an embodiment of the invention . each figure shows how features , i . e ., extensions 1714 and 1754 respectively , can be created by either the software developer ( in order to leverage attributes of the hardware ), or by the hardware developer ( in order to leverage attributes of the software ). these figures also show how tools 1720 , such as c ++ and doodle ( a product of intrinsic graphics , inc .) can be used to facilitate development of an application . [ 0182 ] fig1 shows these relationships from the perspective of data flow during execution . an application 1805 is shown producing output objects 1810 and scene graphs 1815 and 1820 . in the embodiment illustrated , the hardware 1890 is eventually accessed via gap microcode 1885 . before describing the framework application , the components , phases , blocks , connections , and execution semantics , the major elements of the gap from the framework and application developer &# 39 ; s point of view are considered . blocks are the basic elements of the gap framework and define the “ atoms ” of interactive visual computing according to the present invention . the term “ module ” is a general term meaning any of the three classes of blocks : blocks , super blocks , and components . blocks are built by : creating a gap block interface definition using a code generation tool , by editing a standard template , or by coding . this definition specifies the type and name of each input and output connection point and every function , which collectively characterize the interface that the block presents to other blocks . binding compiled procedures or interpreter input scripts to the required executable elements of a block . these procedures include a constructor function , an initialization function , a destructor function , and a single procedure as the implicit computation of the block . the block initialization function allocates internal data using special ark data allocation functions . in an embodiment of the invention , only literal values and dynamically allocated data types derived from intrinsic objects can be accessed over connections . once built , a block is linked into an application or to a higher - level block by constructing connections between its input and output points and compatible points on other blocks . executable block content can be c or c ++ code interspersed with references to special variables or functions that are in fact references to the data output by other blocks . sometimes a block contains several other blocks connected into a processing graph . these are termed “ compound blocks ” and the internal nesting in their definitions is supported to any finite depth . in the future , executable block content may also be scripts in whatever scripting language or languages are supported . blocks are the atomic unit of execution within the gap , and are the level where input and output linkages are attached . the details of connections are presented later , but it is important to understand that in an embodiment of the invention , a block does not know the identity of the blocks that provide its input or that of blocks that connect to its output . data specified in the block interface definition allows the ark to invisibly and efficiently implement this run - time dynamic connection facility for compiled blocks . what defines a block ? in one example , shown schematically in fig6 a block includes the following elements : 1 . as mentioned previously , each block has a set of input connection points . each input point has a name and a type . the name is used when making connections to the block and internally as the name by which data available through the input is referenced . the types may be compound data structures represented by c or c ++ structures , in which case access within the block can be to “ member of name ” in addition to the aggregate “ name ,” though the syntax for this is currently undecided . 2 . blocks have a set of output points , each of which also has a name and type . these names must be distinct from each other and from the input names within the block . each output point corresponds either to an internal data member of the block that is derived from the intrinsic object base class and allocated at run - time , or to a member of such an object . access to these internal objects is provided to other blocks that are connected to the corresponding output points . 3 . blocks may have a set of internal intrinsic objects that are not shared via the output points , and may have a set of other internal objects not derived from the intrinsic object base class . objects that are not derived from the intrinsic object base class may not be shared through connections , and only objects derived from the block base class can have connections . finally , each block can contain one or more functions . the construct ( ), destruct ( ), and initialize ( ) functions provide object lifetime services while the evaluate ( ) function implements the processing of the block . in natively compiled blocks the ark invokes a function via subroutine call whenever the block is to be executed ; in interpreted blocks a registered interpreter is invoked with the body of the evaluation function as the function definition . the taxonomy of gap blocks has three broad families : blocks that implement the ark and gap infrastructure , blocks that represent global resource managers for hardware and public data structures , and blocks that provide application - level features . application - level features are further subdivided based on the breadth of their developer audience : standard blocks that are usable in many applications , market - oriented blocks for wide use within particular industries , and application - specific blocks implementing the details of a particular application . fig5 illustrates this segmentation . the ark - related infrastructure and resource manager blocks are not shown separately ; they are included as elements of the ark ( 502 ) itself . the following describes blocks of each category , along with exemplary functions : 1 . infrastructure blocks . manage processes , threads of control , and physical processors . implement the block interface semantics . provide mutual access exclusion , explicit data sharing , and implicit data privacy . implement time of day clocks and high - precision real - time clocks , counters , and timers . perform data movement , such as memory transfers and asynchronous disk access . support dynamic binding by loading and unloading components during gap execution . efficient low - level parallelism - aware queue , stack , list , and array data structures . high - level public data structures , including the scene graph , the working set , and the image cache . 2 . resource manager blocks . access and allocation of physical resources like multiple processors , graphics pipelines , display channels , texture resources , frame buffer storage , and memory . report data about capabilities , capacities , status , and performance . 3 . standard feature blocks 505 . abstract device management for human input devices , such as keyboards and joysticks . attribute morphing , interpolation , deformation , and evaluation . spatial audio processing . activity logging and playback . configuration file parsing and evaluation . coordinate system processing , including precision management and catenation . culling of sounds , visuals , intersections , and animation . implicit database paging of objects , shapes , textures , materials , and sound . 4 . market - oriented feature blocks 510 . universe model supporting ephemeris time ; geo - referenced temporal positioning ; solar , lunar , and planetary position and appearance ; and , visualization of the star - field and constellations . height above terrain , line of sight intersection , multi - point terrain following , collision detection , and object intervisibility determination . atmospheric model with patchy layered fog , horizon haze , scud clouds , dynamic cloud volumes , directional horizon glow , rain , sleet , snow , and underwater effects . 5 . application - specific feature blocks 515 . these are the blocks that a developer writes to reshape the gap into a particular application . for an demo showing a view of the earth from space , this would include motion models , command line processing , environment variable processing , graphical user interface customization , application - specific database loading and decoding logic , the splash screen , and the ability to spawn a browser for linkage to a web site . the ark 502 and standard feature blocks 505 together are the gap ; the gap , when combined with an industry &# 39 ; s market - oriented blocks 510 , defines a market - oriented development and deployment platform ; and , finally , the gap along with market - oriented feature blocks 510 and a custom collection of application - specific feature blocks 515 , defines a complete application . application - specific feature blocks 515 and market - oriented feature blocks 510 collectively can be oriented in one or more application areas . examples include the mission rehearsal area 520 , the visual simulation area 530 , the film and video production area 540 , and the entertainment and games area 550 . the gap implements a new level of program reuse between applications by providing a very high level structure to define the interrelationships between application components that can then be automatically “ reconfigured ” at run - time to produce an executable application that is well - tuned and structured for the details of the hardware platform . this allows hardware - related blocks such as those related to graphics , video , audio , computation , and networking to be substituted by hardware providers via feature - level “ device drivers ” allowing the fielding of real - time applications that are both portable and differentiated . this is a significant advantage for application developers building advanced graphics applications for pc and other diverse hardware platforms , including cable set - top boxes and enhanced televisions . consider the infrastructure , resource , and standard blocks to be the initial instruction set of the “ gap virtual machine ” or the system services of a “ gap operating system .” market - oriented blocks can extend this core instruction set by adding the features of target markets . they are packaged separately but are used in exactly the same way . blocks representing features and resources are woven together with connections to form the framework application that developers can modify and extend . this modification process is discussed later , after the linkage between blocks has been explained . interfaces are the “ cell wall ” separating a block or component from the outside world . they are a public definition of a block &# 39 ; s input and output connections that serve as named targets for connection construction . they also specify functions within blocks . interfaces are typed and types must match for connections to be made . for type - safety and data integrity , each input and output point also has a specific type that a potential connection must also match for the link to be consummated . output points also privately specify the identity of data internal to the block that is accessed by links to the output point . input points specify ( either explicitly or implicitly ) what local variable or accessor function corresponds to reading and writing data flowing into a block via an input connection . macros can be used to access block inputs so that block construction and ark implementation can proceed while further consideration of interface implementations is conducted . this macro approach also allows alternative techniques to be tested without requiring blocks to be rewritten . this macro approach allows different data binding mechanisms in different gap implementations . a single connection can be established from each block input point to a compatible output point of any other block . 1 . the word “ single ” in this definition means that fan - in cannot be specified at an input attachment point . 2 . “ compatible ” refers to interface compatibility and data type compatibility . the interface definition names ( or identifiers ) must match and the endpoint data types must match . a character string output cannot be connected to a floating - point input , for example . 3 . finally , allowing “ any ” output point as a destination means that arbitrary fan - out at output attachment points is supported . it was mentioned earlier that components were super - block “ factories ” and can be used where blocks are used . in the connection context , the difference is that , in an embodiment of the invention , components can only be connected to resources , which are blocks advertised as designated connection points for components . many properties of connections are explained by visualizing them as one - way pipelines where data flows from an internal intrinsic - object - derived data member through an output point of one block , the producer , downstream to an input point of another , the consumer . an alternate view interprets connections as access by a downstream block to the internal data of an upstream block . this approach more clearly expresses the capabilities , limitations , and semantics of the connection architecture . connections are created at run - time and can be made and broken during execution . for example , moving an eye point through a scene may cause the geometry - paging feature to load a new animation component along with newly paged geometry . the incoming animation block would need to be attached to the camera position resource and the connection would be made as described above . once connected , the camera position output data from within the block owning that information is available within the newly loaded block when the internal accessor functions or representative variables associated with the block &# 39 ; s input points are respectively invoked or accessed . together , blocks and connections provide the special abstraction required for building the gap . they implement a means to specify the arguments for subroutine invocation through a general connection topology that allows changes to the connection topology after the functions have been compiled . they also support efficient transport of data along connections by exchanging indirection handles rather than copying data . in an embodiment of the invention , what happens behind the scenes is much more sophisticated than it may appear at first glance . presenting blocks with this clean dataflow programming model above an arbitrary multiprocessing topology is a fundamental design constraint within the ark . much of the complexity in the ark and the object model underlying all gap - related data types exists to create the illusion that connections work as described above while being extremely efficient and supporting : seemingly sporadic generation or consumption of data between blocks that operate asynchronously or synchronously at differing rates . temporal coherence for time - serialized processing pipelines where megabytes of data must appear to flow through connections with several frames of data in - flight at once . making and breaking connections between blocks can be infrequent events while the amount of data accessed over connections can be in the hundreds of megabytes per second , so an implementation should always prefer faster accesses even at the expense of slower connection construction . connections are a critical element of the gap environment in an embodiment of the invention . they are the mechanism through which blocks can maintain efficient communication while supporting flexible reconfiguration of the interconnection topology at and during run - time . this facility is the basis of “ run - time application optimization through reconfiguration ” which is provided to gap - based application developers through add - on blocks provided by software developers and hardware manufacturers . components are the highest - level objects in the gap environment . they represent a factory for generating new collections of blocks based on an iterative global resource allocation process . they are designed to wisely answer questions of the following form : “ what should be added to the standard framework to insert a particular feature , given that i have a particular hardware configuration and constraints on available resources ?” this is a difficult question to answer because it depends on both local and global information . locally , several available implementations of a feature may be chosen based on constraints , such as the availability of hardware or other resources . globally , one implementation may be preferred to another in order to avoid overuse of a critical resource or to optimize based on application preferences , such as image quality or rendering rate . for example , if features a and b can be implemented using either more memory or more processing , then one implementation of each would be chosen so that total memory use and total cpu use both fit within available resources with the particular choice based on resulting frame rate . components are the packaging of implementation wisdom in a computer selectable bundle . they are what enable developers to reuse previously written software in new applications with confidence that the right “ variations ” will be made in the implementation of reused features . structurally , a component is a container for one or more alternate implementations of a feature . this highest - level representation is illustrated in fig7 where a component 700 contains a list of alternate implementations 701 a through 701 n . [ 0231 ] fig8 diagrams the contents of a single alternate implementation 701 a . associated with alternate implementation 701 a is a list of resources 805 , such as system memory , texture memory , cpu requirements , and data - transfer bandwidths that are required to successfully instantiate the particular implementation . list 805 can also contain information used to reduce these requirements when a resource negotiation is necessary and possibly expand the requirement when resources are abundant . each required resource also has resource negotiation information ; this information supports the consumer - side bargaining in subsequent negotiations over resources . components may also introduce resources into the system , and so alternate implementation 701 a includes a list of resources 810 that are provided by that alternate implementation . each newly created resource also has resource negotiation information ; this information supports the supplier - side bargaining in subsequent negotiations over the new resource . finally , alternate implementation 701 a contains a list of super blocks 815 . the super blocks 815 are the actual implementation . each is tied to a particular phase of execution in the application framework and provides a list of blocks to be executed in that phase . after the components in an application have been identified , each is asked about its resource requirements ; the answer is the list of the alternate implementations and their required resources . aggregating these requirements creates a multidimensional resource allocation problem that is solvable if at least one configuration of alternates fits within system limits . when a single solution exists , the chosen alternative is communicated to each component which then instantiates the corresponding implementation with links into and out of the component , becoming links into and out of the blocks of that implementation . when more than one combination of alternative implementations fits within resource constraints , then the chosen configuration is based on weighting parameters contained in the component definitions and on evaluation equations provided by the application developer . this preferred solution is then communicated with the components which instantiate the chosen alternatives and link them into the framework . if resources are oversubscribed then there is no direct solution , and the system enters a negotiation phase in which each block is asked which of its resource requirements can be reduced and what the penalty would be for making such a trade - off . a typical example would be texture memory resources that could be reduced by one - fourth at the penalty of blurry images . another example could be minimization of system memory resources by incremental paging rather than fully pre - loading data at the expense of extra cpu utilization and data transfer bandwidth consumption . negotiation continues until an acceptable configuration is found whereupon the components instantiate the proper alternative implementations with reduced resources , or , if there are too many “ strong - willed ” components in a constrained environment , until it is found that no solution exists . in this dire case , either a component is removed and the process restarted , or the process exits . the resource allocation process assures that no component &# 39 ; s implementation is instantiated unless all necessary resources are available and that an appropriate decision about which of several alternatives is chosen in response to available resources . for example , in an embodiment of the invention , the universal texture component will have one implementation that relies on a “ clip - map ” resource , provided only in sgi implementations , and one that does not ; in the first case the implementation can take advantage of sgi infinitereality hardware , and in the other a general software version will be employed . components may also introduce resources into the system . in some cases these new resources manage physical resources but in others they will represent attachment points for other blocks . for example , if a morphing component is attached , it would be useful to also advertise just - before - morphing , morphing , and , just - after - morphing attachment points so that other components may attach to these whenever morphing is in use . as a subtlety , note that such “ component on a component ” attachments only make sense when the first component is present ; this means that it is not always a problem if a component is not loaded because of a missing resource . it may just mean that a planned - for contingency did not materialize in the application &# 39 ; s configuration . the application framework defines several phases of execution , which correspond to threads of potentially parallel execution . each alternate implementation within a component is comprised of one or more super - blocks , each associated with a single phase of processing . super blocks may also define new phases , such as a morphing phase in the case of the previous example . as the super blocks of the selected alternate implementation of each active component are instantiated , they are associated with the specified phase as well as being linked to resources by connections . as shown in fig9 the result of instantiating the desired components is a list of phases . associated with each of phases 905 through 925 is a list of zero or more super blocks . many of these lists may be empty . for example , the list for the database - paging phase 910 will be empty if an application suppresses the standard database - paging component without defining a replacement . each non - empty phase list ( 905 and 915 though 925 ) defines a potentially concurrent phase of the application . these phase lists are indicated in fig9 with respect to one example application framework . [ 0242 ] fig1 illustrates how phases that are not empty are then mapped to stages of execution . each execution stage represents a collection of phases that the ark will execute in a single thread . stage 1005 , for example , represents initialization phase 905 , geometry morphing phase 915 , and culling phase 920 . stage 1010 represents drawing phase 925 . algorithms for producing the phase - to - stage mapping are known in the art , and range from the simple “ all phases mapped to a single stage for single - threaded sequential execution ” to the “ each phase mapped to an independent stage for maximal concurrency .” the resulting stages of execution are then prepared for execution by generating an execution order list that arranges the pair wise block orderings imposed by connections into a total ordering of the blocks in the phase &# 39 ; s block list . the ark , as described later , iterates through these lists and invokes the evaluation ( ) function of each referenced block . stages provide a simple expression of a very complex notion : multiple “ main loops of control ” within a single application , where the loops execute at different rates while still reading and updating shared data . preparation to execute an ark - based application includes loading the components listed in the application manifest . the manifest lists each of the user - developed , third party , and market - oriented blocks needed at the top - level of the application . after loading , these components participate in the resource allocation , implementation instantiation , and phase - to - stage mapping processes described previously . compound blocks consisting exclusively of links to other blocks are recursively expanded by instantiating their sub - blocks and links and making the connections indicated by their definitions . at the conclusion of these tasks , the definition of each stage of application execution has been produced ; each with a block execution order list and a corresponding set of blocks and constructed connections . the execution order list resulting from this preprocessing is an input to the ark and the evaluation of such lists is the basic task of the ark . fig1 indicates this structure with a single ark thread manager 1105 executing an execution order list 1110 . in the sequential execution environment , a single ark thread continuously iterates over the execution order list 1110 , selecting and executing some or all of the blocks 1115 a through 1115 n during each pass . partial execution is for cases where blocks run at different rates . for example , if some run at 60 hz ( such as block 1115 a ) and some at 30 hz ( such as block 1115 b ), the ark would iterate at 60 hz but choose the 60 hz blocks all of the time and the 30 hz blocks half of the time . simple blocks represent the finest - grain of potential concurrency from the developer &# 39 ; s point of view , but as described above , it is actually the execution order lists that are the true atomic elements of execution . this results from the fact that each block is referenced by a single block execution order list and it is blocks , rather than particular functions within blocks , that are scheduled by the ark and executed by a potentially concurrent ark thread . concurrent execution is a more sophisticated case where there are multiple ark threads each with its own block execution order list , as indicated in fig1 . supported concurrency modes include multiple threads ( such as ark threads 1215 through 1225 ) on a single processor 1210 ( known as multi - threading or multi - programming ), a single thread such as thread 1215 on each of multiple processors 1210 and 1250 ( termed multi - processing ), and arbitrary combinations of multi - programming and multi - processing . in concurrent execution there are multiple independent block execution order lists 1260 , one list per ark thread . converting the flattened application graph into multiple lists will cause some of the connections between blocks to span an ark thread boundary , with the upstream and downstream blocks in different lists , which has significant implications for shared data . this case is invisible to block developers . neither the links between blocks or the presence or absence of data on such links drives or inhibits the execution of blocks . block execution is controlled by the execution order lists , which are made either before or during execution and which can change during execution . there is a significant distinction between the “ data flowing over dynamic connections between blocks ” structure of the gap and the “ execution controlled by presence of data at block inputs ” nature of pure dataflow architectures . the gap is more like an “ embedded application - level operating system ” that executes blocks by following one or more block execution order lists produced by a scheduler block ( or by static analysis prior to execution .). the gap provides the ability to write programs that automatically and efficiently expand to use available processing resources without developers needing to explicitly architect for concurrent execution . it also provides concurrency with a real - time orientation . these are advantages of the gap compared to other platforms and programming environments . the application graph is the fundamental expression of an application and / or pieces of an application to the application real - time kernel . the ark uses this graph to execute the application as if it were a virtual machine based on the data and processing flow described in the graph . this application graph consists of processing blocks , data interfaces , and data connections . organizing the application in this way is in many ways orthogonal to normal object - oriented programming model . the ark does not dictate the data structures used throughout the application nor the implementation of the processing components . however , it can force developers to define more of the application explicitly and thus enables the kernel to manage the data flow and processing of the application , making many optimizations inherent in understanding the application in its entirety at this level of design . the ark also defines a packaging and run - time management semantic for the process of inserting functionality into the application graph . this semantic is based on the notion of a component . components are feature level packaging of functionality . the ark contains not only the current application graph it is responsible for executing , but a run - time definition dictionary of processing elements and interfaces that can potentially be used in the application . components are able to extend existing definitions and add new definitions to this run - time dictionary . components are also used to negotiate resources such that they can control how they are inserted into the system based on what resources are available to them . correspondingly , the ark &# 39 ; s run - time resource management and performance monitoring is broken down based on these same feature - level components . the ark allocates resources with regard to the component making the request . the ark can also track the components &# 39 ; usage of those resources ( memory , time , processing , bus bandwidth , et cetera ). thus to the kernel , components are much like processes are to a complete operating system — they are the granularity of resource allocation / monitoring . however , because of the knowledge of how the components interact ( via the application graph ), the ark kernel can act as a more intelligent component moderator . instead of having very little knowledge of a bunch of unrelated tasks , the ark has knowledge of how many components fit into a specific overall application structure . because the ark must maintain the overall understanding of modularly written and configured applications , it maintains a complete dictionary of application graph concepts . this dictionary is able to define segments of an application based on several structures that make up the ark application graph . these structures include processing blocks , data interfaces , data connections , and data objects . the definitions of these structures can themselves be modular . in fact , developers of the ark - based application machines can define their application by laying out data interfaces and connection points within an abstract ‘ basis ’ processing block . the ark needs to be able to assemble all of the structural definitions , partial extensions , full extensions , and functional replacements into clearly understood application graph definitions . further , it needs to allow these application definitions to be configured at application run - time . thus dictionary operations include the definition of simple blocks , data interfaces for blocks , connections connecting blocks of like interfaces , compound blocks , and basis blocks . processing blocks contain atomic processing that happens within the application graph . processing blocks have input fields , internal storage fields , and output fields . input fields are , in general , read - only and are updated automatically by the ark . internal storage fields are read / write and are updated only by the block itself ( in general ) via normal c ++/ c field access . output fields are just shadows of either input fields or internal storage fields such that the ark can manage propagation of the outputs without direct interaction with the block . the only communication between blocks is via its inputs and its outputs . however , blocks also are able to interact with the ark &# 39 ; s resource manager to negotiate over resources used within the block . such resources include block processing time , memory allocation , bus utilization , and other resources that are defined in the resource section of this semantic definition . blocks define several functional interfaces . these interfaces consist mainly of initialize , initializeoutputs , reset , and evaluate functions . the ark uses the initialize function to have the block allocate it resources . it uses the initialize outputs function to have the block define to the ark the storage for the block &# 39 ; s output fields . it uses reset to reset the internal state fields of the blocks to a well - defined default . it uses the evaluate function to have the block perform its processing — processing based on its inputs and current internal state fields . block scheduling is performed by the ark . this schedule can be simple and deterministic but can be related to the data available at ports / connectors . most blocks are scheduled by simply linearly walking from the inputs of the current application graph ( which is hierarchical ) through the application graph , scheduling blocks whenever their inputs have refreshed ‘ enough ’ data . the concept of ‘ enough data ’ is defined by the inserting component that relates the block &# 39 ; s scheduling to data availability at the block &# 39 ; s inputs when inserting the block into the graph . this level of scheduling allows for looping constructs , work lists with chunk sizes , and straightforward pass through execution ; however , it may not allow for arbitrary scheduling based on recursion or stack based block execution . simple blocks are the leaf processing nodes in the application graph hierarchy . simple blocks have an evaluation function that is executed whenever the ark schedules the block . simple blocks can be viewed as scheduling points for processing of typed data flowing through its inputs and outputs . compound blocks are a self - contained section of an application graph that is encapsulated into one block . this means that the block has as its inputs the inputs of the graph contained within it . it has outputs corresponding to the outputs of its contained graph . from the level above , a compound block can be scheduled as a simple block — atomically , based on data availability at its inputs . compound blocks also contain name space . this name space is used to create data hitch points for data flowing within the compound block . these data hitch points are named inside the compound block and provide a plug - in mechanism for components to add functionality to a block that has a predefined ‘ basis ’ structure . any compound block can become a basis block by adding named connectors to its internals . these connectors define the semantic for the compound block itself in terms of the data and processing flow . they also provide potential buffering , making the configuration of processing , scheduling , and configuration largely orthogonal to the implementation and design of the processing blocks themselves . the idea here is to put the power in the hands of the original developer of the basis block who is defining how the compound block will function and what types of extensions it can handle . compound blocks that plug directly into the overall application ( the highest level compound block ) are called phases and are specialized basis compound blocks . phases are singled out in the system of compound blocks for several reasons . first , they provide the level of desired configuration granularity of the overall application . second , they provide the desired level of plug - in granularity for components wishing to extend or replace application - level features . third , they currently act as the level of granularity with which the ark can use threads . each phase can be configured to map to an individual thread if necessary . stages are groupings of phases that are mapped to a particular thread . at one extreme , there will be a one - to - one mapping between phases and stages , making ultimate use of available processors and underlying context switching . at the other extreme , there is only one application stage — this one executes all of the application phases based on the same simple scheduling algorithm defined for compound blocks . stages essentially contain a main loop of synchronization , communication , and conditional execution of the phases . blocks are used to describe atomic processing that happens within an ark - based application . the scheduling of the processing is done explicitly based on ark semantics . this is very different from the implicit cooperative stack based control flow used in applications developed with current programming systems . the explicit nature of ark - based processing can lead to more deterministic applications in terms of real - time interactivity and performance . it further allows for optimizations based on a high level understanding of the intent of the application . blocks are fundamental building blocks of the ark . they are themselves hierarchically defined . this definition yields to a view of an application as a recursive compound view of a processing structure with inputs and outputs . the entire application is , in this way , one large compound block with inputs and outputs . further , the application is broken into functionally separable pieces with well defined interconnects ( phases ). theses separable pieces are compound blocks themselves and can be configured and instanced in different ways . further , these separable pieces are themselves compound blocks with their own structure defined in terms of processing and data flow . the ark dictates that all communication with the application happens via explicitly defined data interfaces . these data interfaces differ substantially from the stack - based functional communication mechanism provided by many current programming systems . data interfaces have access to typed data where the ‘ provider ’ of the data on the interface ( a processing block ) and the ‘ user ’ of the data ( another processing block ) do not directly interact or have knowledge of each other . yet , despite this ‘ abstract ’ data interface , blocks can be connected directly ( in implementation ) and are often able to expose internal data without passing that data on a stack via a virtual or non - virtual function call . this type of fast direct access is manageable because of the ark &# 39 ; s knowledge and scheduling of processing blocks within the overall graph . designing an ark based application includes the definition of its data interfaces . in normal functional programming , code modules are broken apart and functional programming interfaces are defined to abstract their interaction . in object - oriented applications , this abstraction is further broken down according to the nature of individual ‘ objects ’ within the overall application and according to how those objects can interact with each other abstractly . in ark applications , rather than defining the application based solely on its functional or object structure , the application is described in terms of the data interfaces available at various places in the overall application structure . these interfaces represent interaction points and , although they describe data flow , provide an inherent structure for the processing blocks that will connect to the interfaces . once again , this level of description takes the flow of data out of the implicit realm of individual system objects or modules and makes it explicit and configurable at a higher level . in effect , these interfaces allow for applications objects / modules to hook into interfaces in many different parts of the system while still interacting in a way semantically consistent with the overall application structure . thus , data interfaces provide an overall feature driver model for entire applications . individual components of the system interact across agreed - upon data interfaces while understanding only the data interface itself and caring nothing of the block or blocks on the other side of the interface . the ark defines the applications data interfaces at several levels . the lowest level of data interface definition is called a pin . pins are defined to represent access to an atomic field being sent or received by a block ( coming from or going to another block ). pins therefore provide a data interface corresponding directly to fields within objects ( e . g ., integer , float , object handle , vector ). pins are separated into two types — inputs and outputs . an input pin must be connected to an output pin or its value is undefined . input pins are accessed much like internal fields during a block &# 39 ; s evaluation . in fact , the basic notion is that the ark assures that a block &# 39 ; s input pins all contain valid data when the block executes . output pins have slightly different semantics however . output pins must have corresponding fields in the block or one of the block &# 39 ; s contained objects . the ark is responsible for passing on output pin values without interaction from the block . this means the ark must have a field - to - output pin mapping for each output pin . to summarize , when a block executes , the ark makes all of the block &# 39 ; s inputs valid and available . when a block finishes executing , the ark conceptually pushes the block &# 39 ; s outputs across to other inputs that are connected to them . in implementation , this merely means that the ark allows other blocks connected to this block &# 39 ; s outputs to sample those data values at semantically appropriate times . pins can be grouped together to form a description of a higher level of data interface called a port . ports are hierarchical in nature and provide a polymorphic type system for complex pin groupings . ports are defined as a list of pins and other ports . ports are first defined via a port type system before port instances are created . this allows for standard port types to be defined and used by multiple developers who seek to attach their individual processing blocks via a standard interface . these port types can also be used by connectors to have not only a standard interface but also a standard point in an application where that interface exists and has particular meaning . port definitions are run - time extensible and are polymorphic . ports represent a way of hierarchically grouping pins together in a standard way — much like creating standard sockets in the hardware world . pins and ports are normally simple and automatic . the ark is responsible for propagating data from output pins / ports to connected input pins / ports . the propagation normally happens automatically inside of the ark and what minimal setup the ark does is carried out in internal ark wrapper functions that surround a block &# 39 ; s evaluation . however , in an embodiment of the invention , the ark allows for ‘ interactive ’ ports / pins to be defined . interactive ports / pins are able to ask the ark to ‘ pull ’ new data in for processing or ‘ push ’ data out for processing . this interactive push / pull semantic allows the flexibility to create blocks that interact with the application or each other in a more fine grained way . note that interactive pins / ports require data buffering and can only be used by ports that are connected to buffered connectors that will be described later in this section . data connections are connections between one block &# 39 ; s input pin / port to another block &# 39 ; s like - typed output pin / port . in an embodiment of the invention , the ark provides only one type of connection — the simple connection . simple connections provide safe direct access of an abstract interface between two blocks . simple connections represent simple data flow via a copy - by - value semantic between two pins / ports . however , the implementation of simple connections is better described with an electrical analogy . in this analogy , inputs are really connected electrically to another block &# 39 ; s outputs . thus when block b &# 39 ; s input is connected to block a &# 39 ; s output , block b &# 39 ; s port effectively samples the actual data in block a when it samples its input pin . this is only safe because the ark makes sure that block a and b are only executed in a semantically consistent fashion and even takes care of multi - buffering block a &# 39 ; s data in the case where a and b are evaluated in different threads . connectors are hub - like hitch points for data . there are two types of connectors . simple connectors act like a dual sided port that exists inside of a compound block separate from any of the blocks that will connect to it . the important thing about simple connectors is that they provide pre - defined name space for components to be developed independently and still interact . when components add functionality to a basis block , they do so by inserting blocks and connecting the ports of those blocks to pre - existing connectors . thus , the connectors provide the overall structure of the compound block and define the interfaces that intrinsic developers will use to communicate . buffered connectors provide not just structural name space , but also provide extra semantics for data flowing through them . buffered connectors are able to support both fan - in and fan - out of data flowing through them . further , buffered connectors can be used as work queues and data routers . buffered connectors allow for data hub connection points that allow modular and configurable application components . they also provide definition for the structure of the application as expressed to the ark . however , buffered connectors can have run - time cost . buffered connectors must have storage for the data that they buffer . further , they can support several simple data filtering and routing options to allow application phases to be extended , replaced , and configured . buffered connectors are useful for allowing fan - in by sequentially providing each data element to the downstream block . buffered connectors are also useful because the ark allows blocks to be scheduled based on the number of elements available in the connector &# 39 ; s buffer . thus simple looping constructs can be implemented for high level pieces of work / functionality . this also allows processing blocks to be simplified to work on sets of inputs while the ark will schedule them iteratively based on inputs available in the current configuration . buffered connectors are also useful for event - driven multi - threaded ( cross - phase ) inter - block communication . data interfaces are fundamental to the ark . they allow code modules to interact efficiently inside of a real - time application using an abstract interface . the lowest level interfaces are atomic field interfaces , i . e ., pins . pins can be grouped into a hierarchically typed structure , i . e ., a port . pins and ports from different blocks can be connected together via simple connections . connections are semantically simple in that they act as pass - by - value data connections . data interfaces can exist separately in the application as name space . such an interface provides symmetric input / output typed data and is called a connector . buffered connectors allow for more advanced data interaction between processing blocks while still expressing the intent of the application to the ark . the odl , according to the present invention , lets developers describe the structure of their programs in a simple , straightforward way . this high level description can be used to realize the program in a way that achieves a higher performance than the mainstream languages and functions on multiple hardware and software platforms . libraries , applications , and the objects contained within them are expressed in the odl . the state information in the objects is expressed in an abstract way so that memory and data transfer can be managed using methods that are tuned for a particular platform . in addition , information can be provided through the odl to enable other kinds of optimizations . the odl , in the embodiment described herein , uses the syntax of the scheme programming language because it can describe arbitrarily complex structures in a straightforward way , it is easily extended with new semantics , it is readable by humans ( provided that it is reasonably formatted ), and it is easily and quickly parsed by the computer . also , it is familiar to many programmers and is supported by many text editors . object : an entity that contains state information , which is structured as encapsulated fields of different types . depending on the types of fields an object contains , it can be connected to other objects , flow between objects in a dataflow program , and be manipulated by a procedural program ( e . g ., one written in c / c ++). object element : a part of an object . an object element typically has a name and holds state information some type . the different kinds of elements are described below . interface : an element that is used for input or output of data into or out of an object . field : an element that holds state information of a certain type . basis : an element that defines an object ( the “ basis object ”) to be used as the basis , or foundation for extensions . the object acquires all the elements of the basis object . extension : an element that defines an object ( the “ extension object ”) to be added . the object acquires all the elements of the extension object and hooks its connections ( defined below ) to the existing connectors . connector : an element that acts as a place to make connections ( defined below ). connectors are typically used inside objects that can be used as bases ; their purpose is to establish fixed points to which extensions can connect . connection : an element that serves as the link for the transfer of data between two objects . a connection connects a source of data ( a field or an object output ) to a consumer of data ( an object input ). series : a special kind of connection that connects in “ series ” with a connector . the purpose is to allow the data that flows through the connector to be processed in multiple , independent ways . block : an object that has at least one input and / or output element and thus can be connected to other blocks in a dataflow program . a block that contains only an evaluate function is referred to as a “ simple block .” all others are called “ compound blocks ” because they are internally comprised of other blocks . in this section , curly brackets denote values to be filled in . square brackets denote items that are optional . an asterisk denotes zero or more of the items preceding it . all odl keywords are case - insensitive . object names , however , are not guaranteed to be case - insensitive because some languages ( notably c and c ++) are case - sensitive . scheme - style comments are supported : a comment consists of all characters between a semicolon and the following carriage return . there are two types of object references : a limited ( normal ) object reference ( objectref ) and a complete object reference ( objectcref ). the objectref operator lets an object definition reference another object definition . only the public elements of the referenced object can be accessed . the parameters to objectref may include any number of the referred - to object &# 39 ; s properties . the objectref operator resolves the reference and replaces itself with the object definition identified by the parameters . the objectcref operator works like objectref except that it allows access to all elements of the referenced object , not just the public elements . this is normally only used with basis and extension elements . an object type specifier can specify either a built - in type , or an object definition . a small number of built - in types is supported for building complex objects . a built - in type is specified using the type operator . for all other object types , the object definition is specified . since most object definitions are defined in one place and referenced by their identifiers , the objectref operator is usually used . however , if an object definition is used in only one place , it can appear “ inline .” independent of what type of object is used , a type specifier can state that the data exists either locally or remotely . a local object is one that is instantiated locally . a remote object is one that exists at another place ( inside another object , for instance ) and is referenced . the pin operator can convert any type specifier to one that is remote . remotely accessed objects can be used in input , output , and connector elements of objects . depending on the elements it contains , an object can be a simple state container that flows through a dataflow program , or it can be a block that can be connected into the program . a state container typically contains fields and functions , whereas a block contains inputs , outputs , internal blocks , connectors , etc . since any object can contain any elements , there is really no sharp distinction between a state container object and a block . a block &# 39 ; s implementation can be made up of a network of internal blocks and fields connected together , as well as an “ evaluate ” function that can perform computations . a block can also contain connectors , to which series connections ( typically used in extension objects ) can be connected . there are alternative ways to implement a block . one way is to explicitly specify a collection of internal blocks , fields , connectors , and connections . another way is to use a basis element and extension elements . in the latter case , the implementation of the basis object is combined with that of the extension objects , forming a new implementation . basis elements can also be used to implement the traditional inheritance of object properties . see the basis section below for more information . all object definitions must contain a list of unique identifiers , which , when taken together , uniquely identify the object definition . the list of unique identifiers is specified by the identifiers property . if the identifiers property is not present , the object is identified solely by its name property . ( object ( identifiers ′ name ′ author ) ( name ′ transmogrifier ) ( author ′ calvin ) . . . ) input and output interfaces are specified by the input and output properties . each has a type specifier , which states the type of data that flows into or out of the input or output . state information is stored in fields . each has a type specifier , which states the type of data that is stored . the value property specifies the initial value of the field . it is used only with the basic types ( int , float , etc .) that have no built - in default values . the owned property only applies to fields that are objects . if set to true , the object will be managed ( instantiated , deleted , etc .). by default , it is set to true . the reset property specifies how the field &# 39 ; s value is to be reset . the default is value , which means it is set to its initial value when it is reset . if set to none , nothing is done to reset its value . the implementation of the evaluate function is specified using the implementation property . the code can either be specified inline ( using the code property ) or in a file ( using the file property ). if the file property is used , the name of the file is optional . if no name is specified , the name is automatically generated . if the file does not exist , it is automatically generated . additional code that is called by the evaluate function need not be identified in the odl program ; it only needs to be present in an accessible library at runtime . a connector is specified using the connector property . connectors can be used in blocks that are intended to be used as basis objects . the purpose of the connectors is to allow extensions to automatically connect themselves to the right place in the basis block &# 39 ; s dataflow program . data flows through a connector . the connector exposes the stream of data so that extensions can tap into it . the data can be modified as it passes through the connector using series connections ( see the series section below ). internal blocks , which make up part of an object &# 39 ; s implementation , are specified using the block operator . as with fields , a type specifier is required to state the type of object to use . in an embodiment of the invention , c ++ functions are supported , and they are callable from c ++ code . a function has a name , a language , a return value , and any number of parameters . for c ++ functions , the parameter order must also be specified . the language is specified using the language operator . in an embodiment of the invention , there is no default value , so every function must have a language property . parameters are specified using the parameter operator . all parameters and the return value must have a type specifier in an embodiment of the invention . parameters must be named ; for c ++ functions , return values do not have to be named . the parameter order can be specified using the parameterorder operator . this function takes two integer parameters and returns a floating point value . ( function ( name fixedtofloat ) ( language c ++) ( return ( type ifloat )) ( parameter ( name highbits ) ( type iint )) ( parameter ( name lowbits ) ( type iint )) ( parameterorder highbits lowbits ) ( implementation ( file ))) a link , or “ wire ,” between two internal blocks or connectors is specified using the connection property . the wire &# 39 ; s properties ( what it connects to ) are specified using the from and to properties . the from property specifies where the input end of the wire is connected . data flows into this end of the wire . the to property specifies where the output end of the wire is connected . data flows out of this end of the wire . the from and to properties each specify the location of an interface element to be connected . they must be compatible with each other ; i . e ., they must carry same data type . in an embodiment of the invention , they each have either one or two parameters . if there is only one parameter , it identifies an interface element ( input or output ) or connector of the block to which the connection belongs . if there are two parameters , then they specify an interface element of an internal block ; the first parameter is the internal block name and the second parameter is the interface name . if a connector is identified in the from or to property of a connection within an extension , it should contain an extra element to specify whether it is identifying a connector in the extension or in the basis block . this is done by adding either “( basis )” or “( extension )” in the general form of the identifier . see the last example below . this connection wires the block &# 39 ; s left input to the x input of internal block a : this connection wires the r output internal block a to the input of internal connector b : this connection wires the rgb output of internal block c to the block &# 39 ; s color output : this connection exist within an extension . it wires the sum output of the extension &# 39 ; s internal block d to the basis block &# 39 ; s connector c : a series connection is a special type of connection that is used in conjunction with a connector . to perform a computation on the data that flows through a connector , the computation can be specified using a series property . the computation is inserted into the flow of data at the connector such that the data flowing into the connector is processed , producing new data at the output of the connector . using multiple series elements , any number of independent computations ( i . e ., computations that have no knowledge of each other ) can be inserted in series at the connector . in an embodiment of the invention , a series property contains three distinct elements : 1 . a connector element that identifies the connector where the computation is to be performed . 2 . a from element that identifies a data source where the new connector data comes from . 3 . any number of to elements that specify the inputs into which the connector data is fed . the basis operator allows the elements of another object to be acquired . a basis element can be used for traditional inheritance of properties , or as a foundation for extension elements . since the basis operator allows an object to acquire the properties of another object , it can be used when several objects share a set of properties . the shared properties are defined in an object , and the object is used as the basis in all the objects that share the properties . in an embodiment of the invention , it is not necessary to name the basis element . this allows the sub object to refer to the base object is elements using the same names . in order to avoid collisions , when the basis element is named , the base object &# 39 ; s elements are given an extra identifier when they are acquired by the sub object . in an embodiment of the invention , the use of a basis does not form an abstraction ; it does not allow polymorphism . the traditional inheritance that allows polymorphism is not supported . instead , abstractions are created through the use of block interfaces . to use a basis for the purpose of extending with extension elements , the basis element must be given a name in order for the basis object &# 39 ; s elements to avoid collisions with those of the extension objects . the extension operator allows the elements of another object to be acquired and hooked up to the existing connectors . in an embodiment of the invention , if the connectors named in the extension &# 39 ; s connection elements do not exist , an error results . the connectors are typically supplied by a basis element . block : ( block ( name { name }) [( input ( name { name }) { typespecifier })]* [( output ( name { name }) { typespecifier })]* [( field ( name { name }) { typespecifier } [( value { value })] [( owned { boolean })] [( reset { none | value | object function })])]* [( block ( name { name }) { typespecifier })]* [( connector ( name { name }) { typespecifier })]* [( function ( name { name }) ( language { language }) [( return { typespecifier })] [( parameter ( name { name }) { typespecifier })]* [( parameterorder { name }*)] [( implementation [( file [{ filename }]) | ( code [{ code }]*)])] ) [( connection ( from { outputidentifier }) ( to { inputidentifier }) )]* [( series ( connector { connectorname }) ( from { outputidentifier }) [( to { inputidentifier })]* )]* [( implementation {( code [{ string }]*) | ( file [{ filename }])} )] [( basis ( name { name }) { typespecifier })] [( extension ( name { name }) { typespecifier })]* ) outputidentifier : { blockname } { outputelement } | { inputname } | { connectorname } | (( name { connectorname }) ( basis | extension )) inputidentifier : { fieldname } | { blockname } { inputelement } | { outputname } | { connectorname } | (( name { connectorname }) ( basis | extension )) an extension object &# 39 ; s connections can refer to connectors in the object in which it is used , which allows it to automatically connect itself into the object . for this reason , an extension object cannot be used in isolation ; the connectors it refers to must be supplied externally , usually via a basis element . in an embodiment of the invention , if a connector is identified in the from or to property of a connection within an extension , it must contain an extra element to specify whether it is identifying a connector in the extension or in the object to which it belongs . this can be done by adding either “( basis )” or “( extension )” in the general form of the identifier . the block shown in fig1 is an adder 1900 , named iadder . it is a simple block because its output 1910 is computed by an evaluate function . two integer inputs 1920 and 1930 are added together to produce the output 1910 . the odl code is shown below . ( block - ( name ′ iadder ) ( input ( name ′ left ) ( pin ( type ′ iint ))) ( input ( name ′ right ) ( pin ( type ′ iint ))) ( output ( name ′ sum ) ( pin ( type ′ iint ))) ( field ( name ′ sumfield ) ( type ′ iint )) ( connection ( from ′ sumfield ) ( to ′ sum )) ( implementation ( file )) ) the implementation of the block &# 39 ; s evaluate function is shown below . it resides in a separate file . the block 2000 shown in fig2 is named iadder3 . block 2000 has three inputs 2010 through 2030 . it is implemented using two iadder blocks and produces a final output 2040 . ( block ( name ′ iadder3 ) ( input ( name ′ left ) ( pin ( type ′ iint ))) ( input ( name ′ middle ) ( pin ( type ′ iint ))) ( input ( name ′ right ) ( pin ( type ′ iint ))) ( output ( name ′ sum ) ( pin ( type ′ iint ))) ( block ( name ′ a0 ) ( objectref ( block ( name ′ iadder )))) ( block ( name ′ a1 ) ( objectref ( block ( name ′ iadder )))) ( connection ( from ′ left ) ( to ′ a0 ′ left )) ( connection ( from ′ middle ) ( to ′ a0 ′ right )) ( connection ( from ′ right ) ( to ′ a1 ′ right )) ( connection ( from ′ a0 ′ sum ) ( to ′ a1 ′ left )) ( connection ( from ′ a1 ′ sum ) ( to ′ sum )) ) this example involves three different objects : a compound block that is used as a basis block , an extension object that extends the basis block , and a block that combines the two through the use of basis and extension elements . this compound block , shown in fig2 , contains two connectors , m and g ( 2110 and 2120 , respectively ), to which an extension can connect . ( block ( name ′ iformula ) ( input ( name ′ x ) ( pin ( type ′ iint ))) ( output ( name ′ f ) ( pin ( type ′ iint ))) ( connector ( name ′ m ) ( pin ( type ′ iint ))) ( connector ( name ′ g ) ( pin ( type ′ iint ))) ( block ( name ′ mult ) ( objectref ( block ( name ′ imultiplier )))) ( block ( name ′ add ) ( objectref ( block ( name ′ iadder )))) ( connection ( from ′ x ) ( to ′ m ′ left )) ( connection ( from ′ x ) ( to ′ m ′ right )) ( connection ( from ′ x ) ( to ′ g )) ( connection ( from ′ m ′ product ) ( to ′ m )) ( connection ( from ′ m ) ( to ′ add ′ left )) ( connection ( from ′ g ) ( to ′ add ′ right )) ( connection ( from ′ add ′ sum ) ( to ′ f )) ) this extension &# 39 ; s connections refer to connectors in the iformula block , and therefore can be used to extend it . it is illustrated in fig2 , and contains a simple program that taps into connector m ( 2210 ) and is inserted in series with connector g ( 2220 ). ( extension ( name ′ imyextension ) ( block ( name ′ a ) ( objectref ( block ( name ′ iadder )))) ( connection ( from (( name ′ m ) ( basis ))) ( to ′ a ′ left )) ( series ( connector (( name ′ g ) ( basis ))) ( to ′ a right ) ( from ′ a sum )) ) this block uses the iformula block as a basis block , which it extends using the imyextension extension , as shown in fig2 . element 2310 corresponds to elements 2110 and 2210 of fig2 and 22 , respectively . element 2320 corresponds to elements 2120 and 2220 of fig2 and 22 , respectively . ( block ( name ′ imyformula ) ( basis ( name ′ b ) ( objectcref ( block ( name ′ iformula )))) ( extension ( name ′ e ) ( objectcref ( extension ( name ′ imyextension )))) ) while various embodiments of the present invention have been described above , it should be understood that they have been presented by way of example , and not limitation . it will be apparent to persons skilled in the relevant art that various changes in detail can be made therein without departing from the spirit and scope of the invention . thus , the present invention should not be limited by any of the above - described exemplary embodiments , but should be defined only in accordance with the following claims and their equivalents .

US-77945301-A

a clothes hanger storage device includes a container and a plurality of pillars inside the container for retaining a multitude of variously - sized and - shaped hangers . the plurality of pillars may be arranged as two sets of pillars , or two elongated pillar units , wherein large triangular hangers extend around both sets of pillars or around the two elongated pillar units , and small triangular hangers extend around only one set of pillars or one elongated pillar unit . non - triangular hangers , such as hangers only comprising two shoulders , may be stored in the container by being trapped between the container wall and the pillars , but not extending around the pillars . the clothes hanger storage device may be adapted to be hung from a door , stored underneath a counter or in a closet , or attached to the door of a cabinet . in an optional embodiment , the container may be fitted with a releasable lid that fits over the top of the container . the preferred lid may be moved to a dispensing position , which leaves room between the container and the lid through which one or more hangers may be removed .

referring to the figures , there are shown some , but not the only embodiments of the invented clothes hanger storage device . in the preferred embodiment , the clothes hanger storage device 100 is used to stack , store , and carry a plurality of differently - shaped and - sized hangers . the clothes hangers comprise a hook h , a neck n , two shoulder sections s ′, s ″, and some hangers may comprise a base b ′, b ″ connecting the shoulder sections to form a triangular hanger ( see fig1 a and 1b ). in the preferred embodiment , the clothes hanger storage device 100 is a generally rectangular container 10 comprising a plurality of side walls — a base 12 , a front wall 14 , a rear wall 16 , and two end walls 18 . the base 12 and the side walls define an interior space 70 , as shown in fig2 . preferably , the two end walls 18 are of equal length and the front 14 and rear 16 walls are of equal length . the front wall 14 comprises an elongated slot 22 that extends from the base 12 of the container to the top edge 20 of the front wall 14 for receiving the clothes hanger hooks h . the container 10 may comprise additional neck structure that extends from the elongated slot 22 and encloses the necks n and hooks h of the hangers . the container 10 is preferably of a height that will carry a reasonable number of hangers , for example 6 ″- 10 ″, so that the container is not too heavy to carry ( see fig4 and 7 ). larger containers may also be desired for clothing stores , dry cleaners , or laundry mats , for example . in the preferred embodiment , the container 10 is rectangular in shape ; however , the inventor envisions that other shapes , such as a triangle , might be used so long as the entire hanger fits within the container . additionally , handles with apertures 21 may be provided in the top edge 20 of the two end walls 18 for grasping the container 10 or for securing a lid 30 to the container 10 . the preferred embodiment further comprises a plurality of pillars extending upward and generally perpendicular to the base 12 of the container 10 . as shown in fig2 and 3 , the plurality of pillars are preferably arranged as two sets of pillars in a triangular fashion — two pillars 22 , 23 are positioned toward the front wall 14 of the container 10 and two pillars 24 , 25 are positioned toward the rear wall 16 of the container 10 . the rear pillars 24 , 25 are in a plane parallel to the front pillars 22 , 23 , but spaced out a distance , so that the respective rear pillars 24 , 25 are closer to the end walls 18 than are the front pillars 22 , 23 . in the preferred embodiment , the pillars are integral with the base 12 of the container 10 meaning they are formed as an extension of the base , preferably by molding . the pillars are preferably not solid , so that there is a detent corresponding to each pillar in the bottom of the base of the container , so that the containers may be stacked one on top of the other with the pillars from one container sliding into the detents created by the hollow pillars of the other container . to accommodate the stacking of the containers , the pillar sides are sloped , as shown to best advantage in fig2 and 3 , so that the tops 26 of the pillars are preferably smaller in dimension than the bottoms 28 of the pillars . the front pillars 22 , 23 are generally cylindrical in shape , and the rear pillars 24 , 25 are generally kidney - shaped ; however , other shapes may be used , such as , conical , rectaganol , or other aesthetically pleasing or easy - to - mold shapes . the sets of pillars are spaced - apart in a triangular arrangement , so that they can accommodate different shapes and sizes of hangers . the spacing between the two sets of pillars is sufficient , so that when a large triangular hanger ( shown in fig1 a ), having a base length between 12 ″ and 14 ″, and a height ( from the base b ′ to the top of the hook h ) between 9 ″ and 10 ″, is placed in the container , the two sets of pillars 22 , 23 and 24 , 25 are completely contained within the framed - space fs of the hanger , and the neck n and the hook h of the hanger extend out through the elongated slot 22 in the front wall 14 of the container 10 ( see fig5 ). additionally , when a small triangular hanger ( shown in fig1 b ), having a base length between 9 ″ and 12 ″ and a height between 7 ″ and 9 ″, is placed in the container , only the front pillars 22 , 23 are completely contained within the framed - space fs of the hanger , and the base b ″ of the smaller hanger is trapped in the space between the front pillars 22 , 23 , and the rear pillars 24 , 25 ( see fig6 ). further , the spacing between the front pillars 22 , 23 and the front wall 14 of the container 10 is sufficient to accommodate a hanger comprising only a hook h , a neck n , and two shoulders , without a base connecting the two shoulders , so that the front pillars 22 , 23 engage the underside of the neck portion and the rear pillars 24 , 25 engage the underside of the two shoulders s . thus , the hanger is trapped between the front wall 14 of the container 10 and the two sets of pillars 22 , 23 and 24 , 25 ; however , none of the hanger extends around the pillars ( see fig7 ). in the preferred embodiment , the relationship between the container 10 , the elongated slot 22 , and the pillars 22 , 23 and 24 , 25 is such that they are oriented to accommodate a wide variety of hangers . the front 14 and rear 16 walls of the container 10 are preferably between 12 ″- 14 ″ in length from corner c to corner c , and the end walls 18 are preferably between 6 ″- 10 ″ long from corner c to corner c , but in the preferred embodiment , they are 7 ″ long ( see fig2 ). the elongated slot 22 , in the front wall 14 , is between 1 ″- 2 ″ in width between its generally vertical walls w ( see fig3 ). the elongated slot 22 must be wide enough to fit differently - sized and - shaped hanger necks , but not too wide that the hanger necks move around significantly . the space between the front most extremities of the front pillars 22 , 23 and the front wall 14 is preferably between 2 . 5 ″- 4 ″. the space between the rear most extremities of the rear pillars 24 , 25 and the rear wall 16 is between 0 . 5 ″- 4 ″. preferably , the relationship between the pillars and the respective walls is close enough in order to tightly retain the hangers around the pillars , or between the walls of the container and the pillars . as shown in fig3 , the two front pillars 22 , 23 are spaced apart a distance d 3 between 2 ″- 3 ″, and the two back pillars 24 , 25 are spaced apart a distance d 2 between 8 ″- 10 ″. the distance d 3 between one front pillar and one rear pillar is preferably between 0 . 5 ″- 1 ″; however , this distance needs to be only as wide as the thickest small triangular hanger base . in an alternative embodiment , the plurality of pillars may be a set of two elongated pillars / units , one elongated pillar 60 being positioned toward the front wall 14 of the container 10 and the second elongated pillar 62 being positioned toward the rear wall 16 of the container 10 ( see fig1 ). preferably , the two elongated pillars 60 , 62 are parallel to each other , and the rear pillar 62 is longer in length than the front pillar 60 . the two elongated pillars 60 , 62 still resemble a triangular shape , so that they can accommodate a variety of hangers . the distance d 3 between the front pillar 60 and the back pillar 62 is preferably between 0 . 5 ″- 1 ″. in the alternative embodiment , the elongated pillars 60 , 62 comprise ends 64 , 66 that are slanted relative to the elongated pillar lengths , contributing to the triangular shape of the outer perimeter of the pillar grouping . in an especially preferred embodiment , the container 10 is fitted with a lid 30 . the lid 30 is adapted to be secured to the top edge 20 of the container 10 ( see fig1 a and 10b ). preferably , the lid 30 is the same shape as the container 10 and the lid 30 is also substantially flat or planar , so that multiple containers could be stacked upon one another with their lids on , and so that the lid may be attached to the underside of a table or counter top ( see fig1 ). further , the lid 30 may be adapted to include latches 40 for further securing the lid 30 to the container 10 . in the preferred embodiment , the latches 40 are attached to the short ends 31 of the lid 30 . the latches 40 comprise a plurality of spaced connection members that may be releasably connected to the container 10 . preferably , the connection members comprise a single protrusion 42 near the top of the latch 40 and a set of two protrusions 44 , 46 near the bottom of the latch 40 ( see fig1 b and 11b ). the latches 40 permit the lid 30 to moved from a closed position , as shown in fig1 a , to a raised or dispensing position , as shown in fig1 a . when the lid 30 is in the closed position ( see fig1 a and 10b ), the latches 40 are slid all the way into the apertures 21 in the top edge 20 of the container 10 , so that the lid 30 is fitted entirely around the top edge 20 of the container 10 , and the single protrusion 42 abuts against the edge 21 ′ of the aperture 21 preventing the lid 30 from coming off of the container 10 . when the lid 30 is in the raised or dispensing position ( see fig1 a and 11b ), the lid 30 is positioned above the container 10 , so that it is generally parallel to , but slightly distanced from the container 10 , and the lower set of protrusions 44 , 46 are positioned around the edge 21 ′ of the aperture 21 . as shown in fig1 b , protrusion 44 is positioned above the edge 21 ′, and protrusion 46 is positioned below the edge 21 ′, so that the edge 21 ′ is trapped between the lower two protrusions 44 , 46 . thus , the protrusions 42 , 44 , 46 act as stops or grips , which retain the latches 40 , and hence , the lid 30 in either of the two desired positions . the protrusions 42 , 44 , 46 may themselves snap onto or around the edge 21 ′, or may simply abut against the edge 21 ′, but preferably there is some resilience in either the protrusions 42 , 44 , 46 or the latch hinges , in order to retain the latches 40 in the selected position once the user has moved the latches 40 ( as discussed below ), and / or purposely snapped the protrusions around the edge 21 ′. in order to move the lid 30 from the closed position to the raised or dispensing position , the user must press the latches 40 toward the end walls 18 of the container 10 , and then raise the lid 30 until the protrusions 44 , 46 snap around the edge 21 ′ securing the lid 30 in the raised position . the latches 40 may be designed to create , in the raised position , a space 50 that is 2 ″- 4 ″ from the bottom of the lid 30 to the top edge 20 of the container 10 . when the lid 30 is in the raised position , the user may remove one or more hangers by sliding the hangers off of the pillars 22 , 23 and / or 24 , 25 , and out through the space 50 between the top edge 20 of the container 10 and the lid 30 . preferably , 1 - 3 hangers may be lifted up and forward out of the device through the space 50 . the latches 40 are preferably made of a sturdy material , so as to support the lid 30 above the container 10 . additionally , other latch mechanisms may be used , such as a latch mechanism that wraps or snaps around the outside of the container wall instead of going through an aperture in the container , such as arm ( s ), rod ( s ), or other fasteners that can hold the lid in multiple positions relative to the container . the lid 30 and / or container 10 may be adapted to include mechanisms for aiding in storing or carrying the clothes hanger storage device 100 . for example , in order to attach the lid 30 to the underside of a table or counter top , holes 34 may be molded into the lid 30 , or otherwise provided , in order to screw the lid 30 into a table or counter top . other means of attaching the lid 30 or container 10 without the lid 30 to a table or counter top may be used , such as adhesive strips , chain links , or the lid 30 and / or container 10 may cooperate with glide rails that allow the clothes hanger storage device to be slid out from underneath the table or counter top . as shown in fig8 and 9 , the lid 30 has apertures 32 that act as a handle for gripping the container and carrying it . the lid 30 may be adapted to have other handle structures , such as a handle that is raised above the lid ; however , this would be less preferable because it would be difficult to stack the containers . additionally , the lid 30 may be adapted to not include a handle and the user could carry the clothes hanger storage device 100 by gripping the sides of the container 10 and the lid 30 . as shown in fig2 and 4 , the container 10 may also be fitted with holes 39 in a side wall for attaching brackets 38 . the brackets 38 preferably have a hooked end 38 ′ allowing the container 10 to be hung from a door , cabinet door , or other structure comprising an edge ( see fig1 ). alternatively , the container 10 may be attached to a door or cabinet by drilling through the holes 39 and securing the container with screws . further , the clothes hanger storage device 100 may be stored in a closet or cabinet with no additional securement mechanism . although this invention has been described above with reference to particular means , materials and embodiments , it is to be understood that the invention is not limited to these disclosed particulars , but extends instead to all equivalents within the scope of the following claims .

US-1337308-A

dough intended for use in producing bakery products is homogenized and advanced to extrusion nozzles where it is cut into successive pieces that fall onto a moving conveyor . the pieces are of precisely uniform weight because a constant pressure is maintained on the dough as it is forwarded by a metering pump toward the nozzles . apparatus for achieving such result includes an auger , a developer positioned downstream from the auger , and a transition chamber fed by the developer and located upstream from the metering pump . a pressure - measuring monitor serves to control the rotational speed of the auger , thereby maintaining the dough under constant pressure within the apparatus .

referring to fig1 - 5 , an embodiment of the dough treating and dispensing apparatus of the present invention is shown comprised of hopper 10 disposed above advancing assembly 11 which is positioned above transition housing 12 , metering pump 13 and extrusion conduits 56 . an outer framework 42 provides support for said components . hopper 10 is of integral construction and tapered downwardly from upper extremity 15 to lowermost exit extremity 16 . the hopper is contoured so as to have no corners where dough might accumulate as a stagnant zone . exit extremity 16 is equipped with an outwardly directed flange 17 which permits sealed joinder to advancing assembly 11 using bolts 18 . a resilient gasket or o - ring , or equivalent means may be employed to assure pressure - tight joinder of the hopper to the advancing assembly . as shown in fig1 , and 3 , advancing assembly 11 is comprised in part of receiver block 19 of generally rectangular configuration bounded by flat upper and lower surfaces 20 and 21 , respectively , flat front and rear surfaces 22 and 23 , respectively , and opposed side surfaces 24 . first and second circular cylindrical bores 25 and 26 , respectively , extend in parallel disposition between said front and rear surfaces . as shown in fig3 a and 3b , sealing bushings 27 and 82 , associated with bores 25 and 26 , respectively , are associated with rear surface 23 . it is to be noted that bushing 27 contains an outwardly directed wiper lip 83 adapted to prevent fluid flow into bore 25 whereas bushing 82 contains an inwardly directed wiper lip 84 adapted to prevent fluid flow out of bore 26 . a coupling block 28 is removably associated with front surface 22 by bolts 29 , and has a passage 30 configured to establish continuity between the front extremities of both bores . a receiving port 31 penetrates upper surface 20 and establishes communication between exit extremity 16 of the hopper and first bore 25 . an auger 32 is housed within said first bore , said auger being comprised of a continuous vane 33 that extends to a radial clearance of 0 . 020 - 0 . 040 inch with respect to said bore , and centered shaft 34 that extends rearwardly to socketed engagement with receiver shaft 35 secured by bushing 27 . to achieve said socketed engagement , the rearward extremity of the centered shaft is of a square contour , matching the contour of pocket 85 of said receiver shaft . the forward extremity of shaft 34 is rotatively supported by bearing boss 81 held by coupling block 28 . by virtue of such manner of construction , auger 32 can be easily pulled out of bore 25 to facilitate cleaning . a de - gassing port 40 extends through block 19 into said first bore at a site rearwardly of vane 33 , and communicates with a vacuum source , not shown . bushing 27 prevents air from being withdrawn into bore 25 in response to the vacuum applied to receiving port 31 . a developer unit 36 is disposed within said second bore , said developer comprised of a plurality of blades 37 equiangularly disposed about shaft 38 that extends rearwardly to socketed engagement with receiver shaft 39 secured by bushing 82 . the blades are radially spaced about 1 / 16 &# 34 ; from the bore . the forward extremity of shaft 38 is rotatively supported by bearing boss 81 held by coupling block 28 . the developer unit 36 , like the auger , can accordingly be pulled out of its bore to facilitate cleaning . the developer may alternatively be of paddle or ribbon design . an exit port 41 extends between the rear extremity of the second bore and lower surface 21 . receiver block 19 and coupling block 28 are preferably fabricated of engineering grade plastic having a low coefficient of surface friction . suitable plastics include ultra - high molecular weight polyolefin , polyacetal , polyester , polyamide , and other moldable plastics having equivalent properties . the rear extremities of receiver shafts 35 and 39 extend to right angle drive units 43 and 44 , respectively , which are driven by inverter - controlled variable speed electric motors 45 and 46 , respectively . the auger and developer are adapted to rotate in opposite directions . a separate inverter electrical speed controller 48 is associated with each motor 46 and 45 . inverter 48 , of standard construction , is designed to receive a control signal which is utilized to control the voltage and frequency of current which powers the respective motor . a suitable inverter controller is the movitrac model g - 2 made by the toshiba company . both motors may be identical , having a horsepower rating in the range of 3 to 7 hp . the auger is typically rotated at speeds in the range of 50 - 250 rpm . the developer is typically rotated at speeds in the range of 50 - 300 rpm . the entire advancing assembly may be constructed so that it may be pivoted upward about pivot rod 49 attached to frame 42 in parallel relationship to end surface 24 adjacent motor 45 . pivoted lifting of the advancing assembly facilitates cleaning and repair . suitable means may be provided to secure the head assembly in its upper , cleaning position , and in its lowermost , functional position . transition housing 12 is disposed below lower surface 21 of said head assembly and configured to establish pressure - tight connection with exit port 41 . the front surface 51 of housing 12 secures a pressure indicating device 52 which senses and indicates the hydraulic pressure within housing 12 . an electronic pressure - sensing transducer 75 inserted through rear surface 76 of housing 12 produces an electrical control signal which is fed to inverter 48 . by virtue of such arrangement , the speed of auger 32 is controlled . because the route taken by the dough within the apparatus is pressure - tight , increased rotational speed of the auger produces increased pressure on the dough at transducer 75 . in general , the configuration of the apparatus and its operating parameters are such that a constant pressure in the range of 15 - 28 psig is maintained at transducer 75 . a rotary positive displacement metering pump 13 is joined in a pressure - tight manner to the underside of housing 12 , and receives dough therefrom . a suitable metering pump is model 34 made by the waukesha company of delavan , wis . said pump is driven by inverter controlled variable speed motor 69 , acting through a right angle coupling 70 , and is characterized in having two dual lobe intersecting rotors 54 . a face plate 57 held by bolts 58 can be removed to facilitate removal of the rotors and cleaning of the interior of the pump . a horizontally disposed distribution manifold 55 is positioned below said pump and coupled thereto in pressure - tight but removable joinder by means of threaded fitting 73 . a plurality of parallel extrusion conduits 56 are downwardly directed from said manifold said distribution manifold and extrusion conduits 56 are exemplified as being fashioned from a single block 79 of engineering grade plastic each conduit contains a pressure drop regulator assembly 59 , as best shown in fig4 comprising a control stem 64 which extends upwardly through manifold 55 to the top of block 79 where it is threadably secured at a desired elevation by means of threaded control knob 71 . a conically tapered plug 61 is disposed upon the lowermost extremity of each control stem , and adapted to abut upwardly with a conically tapered shoulder 62 within conduit 56 a coil spring 63 is interposed between the lowermost extremity of stem 64 and plug 61 . by virtue of such arrangement , upward movement of stem 64 constricts conduit 56 , thereby increasing the upstream pressure of the dough . the lowermost extremity of each conduit has a tapered extrusion nozzle 65 , as best shown in fig4 and 5 , having an orifice 66 that is elongated in the same direction as manifold 55 . a cutting wire 67 mounted upon opposed support posts 78 is disposed below said nozzles , and is adapted to pass back and fourth over said orifices in sliding contact therewith to produce pieces of dough 72 . the motion of the wire is transverse to the direction of elongation of the orifice . such combination of elongated orifice and transverse cutting direction has been found to provide a faster cutting action . the wire is further caused to ride along the tapered sides of the nozzle before crossing the orifice . the sequentially severed pieces of dough fall onto a moving belt 8 of conventional design , which carries the pieces of dough to further downstream processing prior to baking . the aforementioned specialized configuration of nozzle and associated cutting wire reduces dwell time during cutting , thereby enhancing weight uniformity and producing more accurate positioning of the pieces of dough upon the belt . positioning of the pieces is very important in order to assure that the pieces are timed accurately for handling by downstream processing equipment . otherwise , the pieces would jam the equipment and stop the process . the upper portion of the apparatus of this invention , comprising the hopper and advancing assembly may , as a unit , be installed upon existing dough dispensing apparatus . said upper portion in fact includes novel features , as described above , which cause said upper portion to be a separately patentable aspect of the present invention . by virtue of the aforesaid specialized features of the apparatus of this invention , the pressure of the dough entering the metering pump is held constant while minimizing shear degradation . in particular , the pressure of the dough within the apparatus of this invention is controlled throughout a zone defined at its upstream extremity by bushing 28 , and defined at its downstream extremity by tapered plug 61 . the attendant constant density of the dough produces remarkably accurate scaling of below 1 % deviation from a target weight . a further consequence of the method and apparatus of this invention is the production of bakery products of improved textural uniformity . in particular , the pore or cell diameter exhibits less than 4 % variation from the average diameter . while particular examples of the present invention have been shown and described , it is apparent that changes and modifications may be made therein without departing from the invention in its broadest aspects . the aim of the appended claims , therefore , is to cover all such changes and modifications as fall within the true spirit and scope of the invention .

US-29712394-A

a medicine cabinet with a frame whereby tiles can be attached to create a customized cabinet to match a user &# 39 ; s bathroom tiles or personal tastes . the medicine cabinet includes a cabinet body , a door , and a frame imposed on either the door or the cabinet body capable of receiving tiles . the door is rotatably or slidably attached to the cabinet body . to accommodate standard tile widths , the door or cabinet body frames have widths equal or slightly larger than the standard tile widths .

detailed illustrative embodiments of the present invention are disclosed herein . however , techniques , systems and operating structures in accordance with the present invention may be embodied in a wide variety of forms and modes , some of which may be quite different form those in the disclosed embodiments . consequently , the specific structural and functional details disclosed herein are merely representative , yet in that regard , they are deemed to afford the best embodiments for purposes of disclosure and to provide a basis for the claims herein which define the scope of the present invention . the following presents a detailed description of preferred embodiments of the present invention . referring to fig1 , shown is a medicine cabinet 100 comprising a rectangular cabinet body 105 and a single rectangular cabinet door 101 . herein , the cabinet door 101 has a door frame 102 surrounding the entire outside perimeter of the door 101 . tiles 103 are deposited on the front face of door 101 fully covering the door frame 102 . square tiles are shown , however , it is understood that other tile shapes and sizes can be used , and is later exemplified . a mirror 104 is recessively placed on the front surface of the door 101 surrounded by the door frame 102 . in greater detail , as shown in fig2 , the cabinet body 105 has an opened front section and generally comprises a back wall 200 , side walls 201 and 202 , top wall 203 and a bottom wall 204 . preferably , the cabinet body 105 is made of powder coated steel for better performance and durability ; however other materials , such as other metals or wood can be used . european hinges 214 - 215 are used to rotatably mount door 101 to cabinet body 105 . other hinges capable of supporting door 101 with tiles 103 can be used , such as , but not limited to , piano hinge , butt hinge , pin hinge , leaf hinge , concealed hinge , and the like . magnetic door catch 217 and magnet 218 are used to lock door 101 shut . of course , other well known means for keeping a door closed can be used without departing from the spirit of the invention . in addition , an inside mirror 216 recessively mounted on the inside door 101 is used for user convenience . in addition , mirror can be mounted on any other surface of cabinet 100 . also , adjustable or permanent shelving 219 is horizontally placed between cabinet side walls 201 - 202 and is used for better space organization . also , vertical shelves ( not shown ) can be used to further compartmentalize the interior of cabinet 100 . the cabinet 100 can be mounted on a wall surface using holes 210 - 213 on the cabinet back wall 200 . holes 210 - 213 can be pre - drilled or drilled at the installation site . the cabinet 100 is placed on a wall surface and centered such that the holes 210 - 213 are matched with studs in the wall . mounting screws are screwed through holes 210 - 213 into the wall studs to mount cabinet 100 on the wall surface . for recessed installations , pre - drilled holes 206 - 209 are provided on the side walls 201 - 202 of cabinet 100 . a surface , to fit the cabinet body 105 , is constructed using a frame comprising two side studs and top and bottom studs in the wall . the cabinet body 105 is placed within the wall opening while lip 205 , protruding perpendicularly from cabinet walls 201 - 204 , is laid flat on the outside surface of the wall , preventing the cabinet from sliding further into the wall opening . mounting screws are screwed through the holes 206 - 209 into the two side studs . of course , any other well known means for attaching cabinet 100 to any surface can be used . an enlarged and fragmented top view of cabinet 100 is illustrated in fig3 . as shown , the inside and outside mirrors 104 and 216 are recessed in door 101 . the applied tile 103 is recessed in the door frame 102 such that the door surface along mirror 104 and tile 103 is substantially flat . advantageously , the configuration illustration in fig3 achieves a clean , visually pleasing look . frame 102 has a width which is equal to or slightly larger than tile 103 width to eliminate unnecessary spacing . an adhesive 300 is used to attach tile 103 to frame 102 which will be later discussed . of course , any other well known attaching means can be used without departing from the spirit of the invention . fig4 illustrates a medicine cabinet 400 with a multiple door configuration for receiving tiles 413 . a single body 401 is used in conjunction with three doors 402 - 404 . to achieve a continuous single frame look throughout the perimeter of cabinet 400 , each door frame configuration differs between door 402 , 403 and 404 while the doors 402 - 404 remain of the same size . door 402 has a frame with a horizontal top section 405 , a vertical side section 406 , and a horizontal bottom section 407 , leaving one side having no frame section . middle door 403 has a horizontal top section 408 and a horizontal bottom section 409 , while door 404 has horizontal top section 410 , vertical side section 411 , and a horizontal bottom section 412 . additionally , mirrors 416 - 418 are recessively deposited on each door 402 - 404 . side mirrors 416 and 418 are of the same size surrounded by tiles on three sides . the center mirror 417 is horizontally larger than the side mirrors to accommodate for missing vertical side sections 406 and 411 of doors 402 and 404 respectfully . of course , the mirrors can be mounted anywhere in cabinet 400 in any well known manner . shelving 414 ( in this example horizontally placed ) is used for better cabinet organization . additionally , vertical shelves ( not shown ) can be used to further compartmentalize the interior of cabinet 400 . vertical members 415 and 419 are placed perpendicular to the top and bottom walls of cabinet body 401 in order to provide cabinet body support , while member 419 additionally acts as a mounting member for supporting door 403 . it is to be understood that other multiple door configurations , although not shown , can be used in accordance with the present invention . for example , in a two door configuration the middle door 403 is eliminated and a smaller cabinet body is used . additional middle sections 403 can be added with a larger cabinet body to create a multiple door configurations . referring now to fig5 , shown is a medicine cabinet 500 comprising a rectangular cabinet body 501 and a single rectangular mirror door 504 . the cabinet body 501 has an outwardly extended frame 502 surrounding the entire outside perimeter of the cabinet body 501 . tiles 503 are deposited on the front face of the cabinet frame 502 . although square tiles are shown , other tile shapes and sizes can be used , as are later exemplified . the mirror door 504 is rotatably attached to the cabinet body 504 by pin hinges 505 and 506 . other hinges may be used as well to mount the door 504 to the cabinet body 501 such as european hinges , concealed hinges , piano hinges , butt hinges , leaf hinges , and the like . a more detailed medicine cabinet having a cabinet body frame is shown in fig6 . the cabinet body 501 has an opened front section and generally comprises a back wall 600 , top wall 601 , bottom wall 602 and side walls 603 - 604 . adjustable or permanent shelving 605 which is horizontally placed between cabinet side walls 603 - 604 is used for better space organization . additional vertical shelves ( not shown ) can be used to further compartmentalize the interior of cabinet 500 . the cabinet 500 can be mounted on a wall surface using holes 610 - 613 located on the cabinet back wall 600 . holes 610 - 613 can be pre - drilled or drilled at the installation site . the cabinet 500 is placed and centered on a wall surface with holes 610 - 613 matching wall studs for support . mounting screws are screwed into the wall studs through holes 610 - 613 . to recessively install the cabinet 500 , pre - drilled holes 606 - 609 are provided on the side walls 603 - 604 of cabinet 500 . a surface to fit the cabinet body 501 is constructed using a frame comprising two side studs and top and bottom studs . the cabinet body 501 is placed within the wall opening while the cabinet frame 502 is laid flat on the outside surface of the wall , preventing the cabinet from sliding further into the wall opening . mounting screws are screwed through the holes 606 - 609 into the two side studs . of course , any other well known means for attaching cabinet 500 to any surface can be used . an enlarged and fragmented top view of cabinet 500 is illustrated in fig7 . the mirror door 504 can comprise a sheet of a beveled mirror . in contrast , the door 504 can comprise other materials such as wood , plastic , metal , and the like , and can have a mirror layered on the outside surface of door 504 . tile 503 is attached to door frame 502 using adhesive 700 . of course , any other well known attaching means can be used without departing from the spirit of the invention . advantageously , the configuration illustrated in fig7 achieves a clean , visually pleasing look , since the cabinet body frame 502 width is equal to or slightly larger than the tile 503 width . fig8 illustrates a medicine cabinet 800 with multiple doors . a single body 801 and a single frame 803 perpendicularly and outwardly extending from the body 801 are used . the body frame 803 is capable of receiving tiles shelving 804 deposited inside the cabinet body is used for better organization . two sliding mirror doors 805 - 806 are attached to the cabinet body 801 through tracks ( not shown ) and are capable of sliding open and closed in directions 807 - 808 respectfully . alternatively , doors 805 - 806 can be rotatably attached to the cabinet body 801 utilizing hinges similar to those preview described . of course , it is to be understood that additional doors can be used in accordance with the present invention . for example , to make a three door cabinet , an additional mirror door is used and the cabinet body 801 and the cabinet frame 803 are constructed horizontally larger to accommodate the third door . various tile sizes and shapes can be used in accordance with the present invention as shown in fig9 a - 9d . tiles can be chosen of different material such as , but not limited to , glass , ceramic , porcelain , and stone tiles . the thickness can range from ¼ to ¾ inches . the frame for receiving tiles is made slightly larger than the various tile sizes such that a clean look is achieved leaving enough space between tiles and on the edges for mounting . preferably , the spacing between neighboring tiles and the frame is approximately ¼ inches . to use square tiles 900 of fig9 a having the width 903 , the frame width 902 is slightly larger than the tile width 903 . a double square 910 tile design of fig9 b or a larger combination of smaller tiles ( i . e . mosaic tiles ) can also be accommodated . the frame width is made slightly larger than the number of consecutive tiles times the tile width , as illustrated in the example of fig9 b , ( i . e . the frame width 912 is slightly larger than twice the tile width 913 ). different frame widths can be available to accommodate standard square tile sizes such as 1 × 1 , 2 × 2 , 3 × 3 , 4 × 4 , 1 × 6 , 2 × 6 , 1 × 12 , and 6 × 6 inches . preferably , the tile size is 4 × 4 inches . rectangular tiles 920 can also be accommodated by a cabinet door frame or a cabinet body frame 921 . the frame width 922 is made slightly larger than tile width 923 . frame widths should accommodate standard rectangular tile widths such as , but not limited to , 2 × 1 , 2 × 6 , 3 × 6 , 3 × 9 , and 3 × 12 inches . a frame can be available for diagonal tile designs as shown in fig9 d . square tiles 920 and triangular tiles 924 ( which can be formed by cutting a square tile into two ) are placed along the diagonal 923 on frame 921 . frame 921 should have width 922 slightly larger than diagonal length 923 of tiles 920 . other frame widths can be made available to accommodate various ornamental tile designs . these tile designs , well known in the art , can include by way of non - limiting examples : circular , ovular , polygonal , or the like . indeed , any shape , color , and thickness can be used with any type of tile without separating from the spirit of the invention . in addition , pre - fabricated sheets of tiles ( not shown ) can be used in accordance with the present invention . for design variations , the cabinet door frame or the cabinet body frame may be configured in a variety of ways as shown in fig1 a - 10c . fig1 a shows a polygonal frame 1000 having four sides and diagonally cut corners which is capable of receiving standard sized tiles 1001 along its perimeter . also , square shape 1003 as shown in fig1 b can be provided for receiving standard size tiles 1004 . finally , a circular frame 1005 is capable of receiving tiles 1006 cut down for a circular pattern . it is contemplated that any designed shape can be adapted for use with the current invention . fig1 illustrates tile application via an adhesive 1103 to a door frame or a cabinet body frame 1101 . a number of tile adhesives can be used such as but not limited to cement - based , thinset , organic adhesive , latex - based , and the like . easy to use adhesives of premixed and ready to use mastics are preferred ( i . e . organic adhesives ). a membrane layer 1102 over the frame 1101 surface is used to provide protection for tile installations from problematic substrates and external stresses . tile adhesive 1103 is applied covering the complete surface of membrane 100 . the tile 1100 is then installed directly to the adhesive 1103 . finally , grout or silicon sealer is applied to fill in the spacing . for an even easier tile installation , an adhesive system comprising a double sided adhesive on a roll can be used . the roll would be cut to the frame shape , peeled to expose the adhesive , and applied to the frame . the cabinet can be sold with the roll already cut and adhered to the frame . to install the tiles , a user simply peels a film from the face of the roll to expose the adhesive and applies the tile to the exposed adhesive ( located on the frame ). mounting is finished with the application of grout or silicon sealant to fill in tile spacing . alternatively , a removable tile application shown in fig1 and 13 is used for quick , easy , and removable tile installation . two tracks 1202 - 1203 are mounted perpendicularly to the frame 1200 edges . each track 1202 and 1203 is of a ‘ u ’ configuration along the cross section . the tracks can be made of any well known material and mounted in any known manner . to install tile 1201 , the tile edges should be aligned with tracks 1202 - 1203 such that the edges can be inserted into tracks 1202 - 1203 and slide along tracks 1202 - 1203 . a locking mechanism ( not shown ) can be used to lock the tile in place and prevent it from falling out . the tracks 1202 - 1203 are constructed to be able to accept standard tile thicknesses such as ¼ to ¾ inches thick . with a removable tile configuration , the tiles 1201 on the cabinet door frame or cabinet body frame 1200 can be removed and changed as desired . of course , a removable tile system is not limited to the use of two tracks . it is contemplated that any other means for attaching the tiles to a door or cabinet frame can be used in accordance with the present invention .

US-18349105-A

an electrophysiology catheter suitable for radiofrequency ablation of cardiac tissues comprises a proximal section , a catheter shaft section and a distal section whereby a distal loop electrode having a temperature sensor and a close - loop temperature control . a conducting wire extends through the lumen and is connected to the loop electrode . the steerable catheter having a loop electrode is inserted into the chambers of the heart to create a continuous , non - linear lesion by supplying radiofrequency energy to said conducting wire .

an electrophysiology catheter constructed in accordance with the principles of the present invention comprises : a catheter shaft having a distal tip section and a proximal section having a connector . fig1 shows a prospective view of the catheter having a catheter shaft 1 . the tip section has a loop electrode 2 and a hollow sheath 7 where the loop electrode can be retracted backward . the connector 3 at the proximal end of the catheter is part of the handle section 4 . the handle has one steerable mechanism 5 and one retractable mechanism 6 . the steerable mechanism 5 is to deflect the loop electrode when the loop electrode 2 is formed outside of the sheath 7 . by pushing the front plunger 8 of the handle , the loop electrode deflects to one direction . by pulling the front plunger , the loop electrode either returns to its neutral position . the retraction mechanism constitutes a flat wire which resists buckling inside the shaft 1 and the handle 4 . in one embodiment , one end of the flat wire is soldered to the base of the tip section having a loop electrode while the other end is soldered onto the rear plunger 9 . the rear plunger is used to push the tip section outwards of the sheath for ablation purpose . while the catheter is introduced into the body or removed from the body , the tip section comprising a loop electrode is retracted into the sheath 7 by pulling back the rear plunger . fig2 shows a close - up view of the tip section of fig1 . the tip section comprises a loop electrode 2 . in one embodiment , the loop electrode is formed of a conducting material . the loop electrode is soldered to a flat wire 10 at the base 11 of the tip section . in another embodiment , the loop electrode is a spiral wire wrapped outside of the tubular loop shaft and forms a continuous loop . the spiral wire electrode has a conducting wire which is insulated , piercing through the tubing shaft into the lumen . said conducting wire passes through the lumen and is soldered to a contact pin of the connector . the tip section having a spiral wire electrode or a loop electrode formed of conducting material can be extended out of the sheath and retracted into the sheath by a retraction mechanism at the handle . to prevent blood from backflow into the sheath 7 , a silicone type stopper 12 is installed at the opening end of the sheath . fig3 shows a cross - sectional view of the tip section with one type of steering mechanism . a steering wire 13 is firmly attached onto the flat wire 10 at the contact point 14 . in this embodiment , the flat wire forms the skeleton of the loop electrode while a pliable plastic shaft covers over the flat wire . the metallic electrode , either a flexible meshed metal electrode , a flexible coiled metal electrode , a flexible coiled spring electrode , or a combination of the above , is placed outside of the plastic shaft . by pulling the steering wire 13 from the handle , the distal portion of the catheter shaft comprising a loop electrode shall deflect to one direction . by pulling another steering wire on the opposite side of the said flat wire , the loop electrode shall deflect to the opposite direction . fig4 shows a cross - sectional view of the tip section with an alternate steering mechanism . two separate steering wires are extended into the branches of the loop electrode . one steering wire 15 is attached on the metal loop 16 at the soldered point 17 . the second steering wire 18 is attached on the metal loop 16 at the soldered point 19 . at the turning point 20 , the steering wires 15 and 18 are elevated from the flat wire 16 so that the steering force pulls the loop electrode to deflect to one direction . to effect bi - directional deflection , another pair of steering wires can be attached on the opposite side of the flat wire 16 to yield the deflection to the opposite direction . an insulated conducting wire from the loop electrode is connected to the contact pin of a connector at the proximal end of said catheter . the conducting wire from the connector end is externally connected to an ekg for diagnosis or to an rf generator during an electrophysiology ablation procedure . from there , the rf energy is transmitted through the conducting wire to the loop electrode and delivered the energy to the contact tissue . a temperature sensor , either a thermocouple or a thermister , is constructed for the loop electrode to measure the tissue contact temperature when rf energy is delivered . the temperature sensing wire from the thermocouple or thermister is connected to the contact pins of the connector and externally connected to a transducer and to a temperature controller . the temperature reading is thereafter relayed to a close - loop control mechanism to adjust the rf energy output . the rf energy delivered is thus controlled by the temperature sensor reading or by the pre - programmed control mechanism . in other embodiment where the loop electrode is formed of a conducting material , the insulated flat wire serves the same function as a conducting wire . rf energy can be transmitted to ablate the tissue through said flat wire . from the foregoing , it should now be appreciated that an improved ablation electrophysiology catheter having a loop electrode and a steerable mechanism has been disclosed for electrophysiology ablation procedures . while the invention has been described with reference to a specific embodiment , the description is illustrative of the invention and is not to be construed as limiting the invention . various modifications and applications may occur to those skilled in the art without departing from the true spirit and scope of the invention as described by the appended claims .

US-81378597-A

heat - shrinkable tubes are fitted on a dress hanger or its clips and are then shrunk by heating them until the tubes are tightly secured to the hanger or its clips . the tubes are flocked or are otherwise provided with a constituent exhibiting a non - slip property at locations where the tubes will come into contact with clothes hung on the hanger . the clothes are thus prevented from slipping on the hanger .

fig1 shows the first embodiment . the dress hanger a of this embodiment comprises a hook 1 , arms 2 extending in opposite directions from the hook 1 and a hanger bar 3 extending between the arms 2 . tubes 4 having flock a are fitted on the hanger and fixed in position by heat shrinking . more specifically , as shown in fig2 a tube b of a heat - shrinkable synthetic resin and having flock on part of its surface is prepared . the tube b is cut into lengths as shown by chain lines in fig2 to form the short tubes 4 having a predetermined length . the tubes are fitted on the arms 2 as shown in fig3 a and 3b and are heated to shrink and fix them to the arms 2 as shown in fig3 c . as shown in fig4 another heat - shrinkable tube b &# 39 ; having its entire surface flocked is prepared . the tube b &# 39 ; is cut as shown by chain lines of fig4 to form tubes 4 &# 39 ; having a predetermined length . the tubes 4 &# 39 ; are fitted on the hanger bar 3 and heated to shrink and fix them to the bar 3 . then as shown in fig1 the hanger bar 3 is hooked to the arms 2 . instead of having the entire surface of the tube b flocked , it may be flocked only at portions of its surface which are to be brought into contact with clothes . for example , as shown in fig5 a plurality of flocked portions a may be provided at predetermined intervals . also , as shown in fig6 a , instead of providing flocked portions a , a non - slip material 4a such as sponge may be stuck on the surface of the tube b . otherwise , as shown in fig6 b , only the portion of the tube to be brought into contact with clothes may be formed of a non - slip material 4a while the remainder of the tube is formed of a heat - shrinkable film 4b . the boundaries therebetween are connected together in a conventional manner such as by welding or bonding . it is also not necessary to have the entire surface of the tube b &# 39 ; flocked . only its portions to be brought into contact with clothes may be flocked . also , such portions may be formed of a non - slip material 4a such as sponge . also , as shown in fig7 a and 7b , the tube b or b &# 39 ; may be made of a heat - shrinkable film 4b having its edges 4b &# 39 ; bonded or welded together . each film is provided with a strip of flock a or a non - slip material 4a extending over the entire length thereof ( fig7 a ) or with a plurality of such strips arranged at predetermined intervals in the longitudinal direction thereof ( fig7 b ). the films 4b may be bonded to form a tube after they are fitted on the arms 2 or the hanger bar 3 . with this arrangement , the tubes can be fitted even on a hanger having its arms 2 and hanger rod 3 integrally formed ( shown in fig8 ). in the case of a dress hanger a having no hanger bar 3 , the tubes 4 are fitted on its arms as non - slip means . as shown in fig9 this embodiment is a dress hanger a &# 39 ; for hanging a skirt by clamping it with a pair of clips 11 secured to a hanger body 10 made of a stainless steel wire . as shown in fig1 , each clip 11 comprises a pair of clip arms 12 , a pivot shaft 12a pivotally supporting the clip arms 12 and a spring 13 biasing the clipping arms 12 toward a closed position . tubes 14 provided with portions of flack a are fitted on the clipping portions of the clip arms 12 . as shown in fig1 , the tubes 14 are made by cutting to predetermined lengths , a tube b &# 34 ; made of a heat - shrinkable synthetic resin and having flock a over the entire surface thereof . the tubes 14 are fitted on the hanger and are shrunk by heating to fix them in position . as shown in fig2 and 15 , the tubes b &# 34 ; may be provided with flock a only at portions to be brought into contact with clothes . also , as shown in fig6 a and 6b , the tube b may comprise a non - slip member 4a such as sponge and a heat - shrinkable film 4b . as shown in fig7 a and 7b , the film may be formed into a tube by bonding its side edges together . as shown in fig1 , the clip arms 12 may have their clip end portions 12b turned in so that when clamping clothes , they are positioned parallel to each other . the clip end portions 12b should preferably have a corrugated cross - sectional shape as shown in the same figure . the tubes 14 may be fitted to cover the entire length of the clip end portions . similarly , in the case of the dress hanger a &# 39 ; shown in fig9 the tube b &# 39 ; may be fastened to the horizontal portion 10a of the body 10 except at the clips 11 . the cutting of the tubes b , b &# 39 ; and b &# 34 ; and the fitting and heat - shrinking of the tubes 4 , 4 &# 39 ; and 4 &# 34 ; can be done manually or automatically . the fibers constituting the flock may be of any kind as long as they have non - slip properties .

US-89025492-A

a method and apparatus for an exercise device comprised of two poles affixed to a base , the poles can move omni - directionally in the base . a user grasps and leans on them for support , while letting his body fall between the poles . the user then pulls the poles together while pulling himself up . in this manner the muscles of the spine , back , abdominals , obliques , upper arms , chest and forearms are stretched and stressed for exercise .

the following description , and the figures to which it refers , are provided for the purpose of describing examples and specific embodiments of the invention only and are not intended to exhaustively describe all possible examples and embodiments of the invention . a solution to the above problem has been devised . referring now to fig1 - 2 the apparatus of the present invention is shown . an exercise device 19 comprises a base portion 21 having a face plate 23 affixed to it , for example affixed by screws . the base 21 may be a crosscut hollow rectangular box but in the preferred embodiment the base is a solid block , perhaps of plastic or wood . it is preferred that the profile of the front side 26 a and bottom side 26 b of the base be formed at a ninety - degree angle to allow it to be placed at the juncture of a floor and a wall . for most uses the front side 26 a of the base portion is formed to rest against a vertical surface such as a wall and bottom side 26 b is formed to rest upon a surface such as a floor . front side 26 a and bottom side 26 b of the base 21 are joined by angled side 26 c . in this embodiment it is further envisioned that front side 26 a will abut a wall and be covered with vinyl , rubber or other material , shown at 21 ′, to enhance the friction between the wall and the base to thereby secure the base from slipping . the bottom side 26 b may also be covered in these materials to enhance the friction between the floor and the base to thereby secure the base from slipping . the base may , however , instead be secured in place to a floor by other methods , such as screwing or bolting the front of the base 21 to a vertical wall or the bottom of the box 26 b to a floor . hemispherical sockets are formed in the angled side 26 c to be substantially the same distance from the surface or floor that bottom side 26 b rests on . the face plate 23 of the base further has two openings , first opening 24 a and second opening 24 b . first opening 24 a and second opening 26 b are formed such that , when assembled , each hemispherical socket 25 is aligned with an opening . each hemispherical socket is adapted to receive a ball 27 that is affixed to the end of a pole on a stud portion 27 ′ of the ball ; first pole 29 and second pole 31 each have a ball affixed to their ends . the ball of each pole moves within its socket to allow the user relatively free omni - directional movement of the poles . the diameter of each opening 24 a and 24 b formed in the face plate 23 is just smaller than the circumference of the ball situated within the respective socket , so that the ball will be retained within the hemispherical socket by the face plate , as detailed in fig1 a and 2 . each pole 29 and 31 is preferably made of metal such as steel or aluminum and is comprised of a plurality of sections to allow it to telescope . the ball 27 is securely fixed to the end of the pole , to be retained by the face plate . in the preferred embodiment there are three concentric telescoped tubular sections 41 ′, 41 ″ and 41 ′″, each of about twenty - four inches in length . in one section adjusting holes 33 for snap button 39 fasteners , known in the art , are provided to allow the use to adjust the length of each pole , as detailed in fig1 b . in this manner the poles may be adjusted to the preferred length by the user . the poles may also be collapsed altogether for easier storage or transportation . the handle 35 end of the pole located distal the ball is preferably covered with vinyl or rubber to allow a secure grip by the user and may be further equipped with loops 37 to catch the arm of the user if his grip should fail . referring now to fig3 - 4 , the preferred use of the present invention is shown . these figures each show a user from the side and a corresponding view from the front while using the present invention [ 0020 ] fig3 a and 3 b show corresponding views of a user in a first position . the user grasps the handles and supports himself by leaning on the poles . the user &# 39 ; s head is about three to three and a half feet from a wall ( not shown ) abutting front side 26 a in this position . from the first position the user moves the poles laterally outwardly from the body , allowing the body to fall forward to between the poles to a second position , shown in corresponding fig4 a and 4 b . from the second position the user forces the poles toward each other while pushing the body upwards to bring the body back to the first position , as indicated by arrows . while in the second position the back is flexed in a concave position between the users shoulders and hips . the shoulders are also stretched while in the second position . the user repeats this motion from the first position to the second position for a desired amount of time . adjusting the poles 29 and 31 to use a shorter pole length results in an increase of this flexing and stretching . the concentric telescoped tubular sections are adjusted by depressing the adjusting snap button fasteners into their holes and then moving the pole tube telescopically to achieve the desired length . shorter pole lengths make the exercise progressively more rigorous and thereby promotes greater strength and flexibility . in this manner muscles of the spine , back , abdominals , obliques , upper arms , chest and forearms are stretched and stressed for exercise . this cycle is repeated until the user has achieved sufficient exercise . it will be appreciated that the invention has been described hereabove with reference to certain examples or preferred embodiments as shown in the drawings . various additions , deletions , changes and alterations may be made to the above - described embodiments and examples without departing from the intended spirit and scope of this invention . accordingly , it is intended that all such additions , deletions , changes and alterations be included within the scope of the following claims .

US-14312402-A

a new and distinct cultivar of lantana plant named ‘ sunset orange ’, characterized by its low growing , mounding to spreading growth habit ; leathery , scabrous dark green foliage ; continuous flowering ; and light orange flower buds that open to light orange and age to dark orange .

in the following description , color references are made to the royal horticultural society colour chart , 2001 edition , except where general terms of ordinary dictionary significance are used . plants used for the description were approximately six months old and were grown in 8 l containers in full sun under outdoor conditions in a nursery in watkinsville , ga . female parent .— lantana sp . cultivar ‘ chapel hill gold ’ ( u . s . plant pat . no . 21 , 539 ). male parent .— lantana camara unnamed seedling known to the inventor as lantana camara dio ( not patented ). propagation : stem cuttings . time to initiate roots , summer : about 10 days at 32 ° c . plant description : herbaceous flowering plant , subshrub , low growing , mounding to spreading growth habit . freely branching ; two lateral branches potentially forming at every node ; pinching enhances lateral branch development . root description .— numerous , fine , fibrous and well - branched . plant size .— about 45 cm in height from the soil level to the top of the inflorescences , and about 60 cm in diameter . young stems having a diameter of about 3 mm and a squarish shape . mature stems having a diameter of about 4 mm or more and a rounded shape . stem strength .— strong , but flexible . stem texture .— coarse , pubescent . stem color ( young ).— 144a . color ( mature ): 199b . internode length .— about 2 . 2 cm . color .— 144a . size .— about 1 mm in length and about 1 mm in width . arrangement .— opposite , simple . length .— about 3 cm . width .— about 2 . 3 cm . shape .— ovate . apex .— acute . base .— cuneate . margin .— crenate . texture ( upper surface ).— leathery , moderately waxy , with scabrous pubescence . texture ( lower surface ).— rough , with hispid pubescence . venation pattern .— pinnate . venation color ( upper surface ).— 144b . venation color ( lower surface ).— 144a . fragrance .— pungent , mint - like . color of developing and mature foliage ( upper surface ).— 147a . color of developing and mature foliage ( lower surface ).— 147b . petiole length .— about 6 mm . petiole diameter .— about 2 mm . petiole texture , both surfaces .— hispid pubescence . petiole color ( upper and lower surfaces ).— 144b . flower type and habit .— small salverform flowers arranged in axillary corymbs ; flowers face mostly upward or outward . flowers are self - cleaning . freely flowering with potentially two inflorescences per node ; typically about 20 to 25 flowers per corymb . natural flowering season .— spring until the first frost in fall ; flowering is continuous . flower longevity on the plant .— about one week . fragrance .— none observed . inflorescence diameter .— about 3 . 4 cm . inflorescence height .— about 1 . 5 cm . flower bud length .— about 1 cm . flower bud diameter .— about 3 mm . flower bud shape .— oblong . flower bud color .— 21a . flower appearance .— flared trumpet , corolla fused , four - parted ; flowers roughly rectangular in shape . diameter .— about 9 mm . corolla tube length .— about 8 mm . pedicels .— none observed , flowers not stalked . arrangement / appearance .— single whorl of four petals , fused into flared trumpet . petal length from throat .— about 5 mm for the upper petal , about 4 mm for the lower petal , and about 3 mm for the lateral petals . petal width .— upper and lower petals are about 6 mm in width , and lateral petals are about 3 mm in width . petal shape .— spatulate to somewhat orbicular . petal apex .— obtuse . petal base .— fused . petal margin .— entire . petal texture , upper and lower surfaces .— smooth , glabrous . petal color ( young ).— upper surface : 21a and lower surface : 17c . color of throat .— 21a . color of corolla tube .— 17c . petal color ( mature ).— upper surface : n25b and lower surface : 26b . color of throat .— n25b . color of corolla tube .— 21d . arrangement / appearance .— the calyx consists of 5 sepals fused into a single tubular structure . length is about 4 . 5 mm . width is about 1 . 5 mm . sepal base .— fused . sepal apex .— acute . texture , upper and lower surfaces .— scabrous . color , upper and lower surfaces .— 146a . arrangement / appearance .— one bract per flower at the base of the corolla , leaf - like . length is about 6 mm . width is about 1 . 5 mm . shape .— lanceolate . apex .— acute . margin .— entire . texture , upper and lower surface .— scabrous . color , upper and lower surfaces .— 146a . length .— about 4 . 5 cm . diameter .— about 1 . 5 mm . angle .— about 45 degrees from the stem . strength .— flexible , but strong . color .— 144a . quantity / arrangement .— four per flower , adnate to the inside of the corolla tube . anther shape .— oblong . anther length .— 1 mm . anther width .— less than 1 mm . anther color .— 13a . pollen amount .— produced in very small quantities , and 13a in color . quantity .— one inferior pistil per flower . pistil length .— about 4 mm . stigma shape .— rounded . stigma size .— about 1 mm in diameter . stigma color .— 145c . style length .— about 2 mm . style color .— 145d . ovary size .— about 1 mm in diameter . ovary color .— 145b . type / appearance .— drupe . shape .— round . diameter .— about 5 mm . mature color .— 202a . number per infructescence .— ranges from zero to about five . disease / pest resistance : plants of the claimed lantana variety grown in the garden have not been noted to be susceptible or resistant to pathogens and pests common to lantana . weather and temperature tolerance : plants of the new variety have been observed to be cold hardy to u . s . cold hardiness zone 8 .

US-201213374634-V

according to the present invention , a temperature controlled therapy device is provided which maintains a desired temperature in a fluid . the temperature controlled therapy device includes a fluid reservoir , a temperature controlled fluid , a watertight blanket having an internal space located therewith , a conduit connected between an exit port of the reservoir and an entry port of the blanket and between an exit port of the blanket and an entry port of the reservoir for defining a fluid circuit within which the temperature controlled fluid may circulate , a pump for circulating the temperature controlled fluid through the fluid circuit , a differential temperature sensor for generating an output signal proportional to a difference in fluid temperature in the blanket and a temperature at a remote location , an absolute temperature sensor for generating an output signal proportional to the temperature at the remote location , a control circuit having as inputs the outputs of the differential temperature sensor and the absolute temperature sensor for generating a control signal for operating the pump in order to maintain a defined temperature range in the fluid in the blanket , and a power supply for supplying power to the device .

with initial reference to fig1 the invention relates to a temperature controlled fluid therapy device 10 for providing hot and cold therapies to an ailing area of a patient for rehabilitation of the patient . in a preferred embodiment of the invention , the temperature controlled fluid therapy device 10 includes a fluid reservoir 12 , a circuit board 14 including a control circuit 129 ( fig5 and 6 ), a fluid conduit 16 , a submersible continuously variable pump 17 , a temperature controlled fluid blanket 18 and sensors 20 and 22 . fluid reservoir 12 is preferably constructed of a thermoplastic material , plastic or rubber , and has a fluid handling capacity of between about 4 liters and about 6 liters . preferably , fluid reservoir 12 includes an interior wall 24 which forms a cavity 26 between the interior wall 24 and outer wall 28 . it is preferred that the cavity 26 be filled with an insulating material such as a gas under vacuum conditions , or styrofoam , alternatively , the interior wall may be constructed of an insulating material such as foam or plastic , formed adjacent to the outer wall 28 . fluid reservoir 12 includes a fill port 30 which is generally circular in shape having a diameter of between about 3 . 75 inches and about 4 . 75 inches . the filler port 30 includes a threaded neck 32 extending outward from the outer wall 28 of the fluid reservoir 12 for threadably engaging a complimentary threaded enclosure 34 . it is preferred that the enclosure 34 be constructed so as to insulate the fluid reservoir 12 , substantially preventing the evaporation of fluid contained therein . as will be discussed in more detail below , the fluid reservoir 12 preferably includes an entry port 36 and an exit port 38 for admitting and expelling fluid into and out of fluid reservoir 12 , respectively . a submersible continuously variable pump 17 is housed within the fluid reservoir 12 . the pump 17 preferably has a throughput of between about ¼ gallons / hour and about 10 gallons / hour . the pump 17 is connected to the printed circuit board 14 via wires 40 providing a continuously variable power supply to the pump 17 by utilizing power source 42 , to be described more fully below . the submersible pump 17 includes an intake 44 port and an output port 46 . when the pump 17 is operating , fluid within reservoir 12 is drawn into the intake port 44 of pump 17 and forced out through the output port 46 of pump 17 and into the connector 48 . in an alternative embodiment of the invention , a hand pump 19 ( fig8 ) may also be included , operable to provide an alternative pump means for the device 10 . the hand pump 19 is preferably disposed adjacent the fluid conduit 16 , and includes two one - way check valves for pumping fluid through the fluid circuit . if a pump 17 is not included in device 10 , or if the pump 17 is inoperable or malfunctioning , the hand pump 19 is effective to pump fluid between the reservoir 12 and the watertight blanket 18 . the connector 48 is preferably a flexible plastic or rubber hose having a diameter of between about ¼ inches and about ⅜ inches . as shown in fig1 the connector 48 fluidly connects the output port 46 of the pump 17 with the exit port 38 of the fluid reservoir 12 . a strap 160 may also be attached via fasteners 162 to the reservoir 12 for ready portability of the fluid therapy device 10 ( fig8 ) the fluid conduit 16 preferably comprises two elongate tubes , intake conduit 50 and output conduit 52 , each having first ends 132 and 134 , and second ends 136 and 138 , respectively . it is preferred that the intake conduit 50 and the output conduit 52 are enclosed with an insulating layer 53 of material such as foam rubber or foam plastic ( fig7 ). the insulating layer 53 of material tends to keep the fluid circulating within the intake and output conduits 50 and 52 , respectively , at a relatively constant temperature with little heat transfer into or out of the insulating layer 53 . preferably the elongate tubes , intake conduit 50 and output conduit 52 are composed of similar material as the connector 48 , having diameters of between about 0 . 25 inches and about 0 . 75 inches and lengths of between about 4 feet and about 8 feet . the first ends 132 and 134 of elongate tubes 50 and 52 are preferably fixedly secured within the fluid reservoir 12 . the first end 132 of the intake conduit 50 is secured within reservoir 12 so that the end 132 is in fluid communication with the interior of the fluid reservoir 12 . the first end 134 of the output conduit 52 is preferably secured to the connector 48 , forming a fluid path between the output port 46 of the pump 17 and the output conduit 52 . as shown in fig2 and 3 , identical female spring actuated quick - release snap fit couplers 54 are attached to the second ends 136 and 138 of the intake conduit 50 and output conduit 52 , respectively , and are formed to accept complimentary male snap fit couplers 56 located adjacent to the first ends 140 and 142 of an inflow conduit 58 and outflow conduit 60 , respectively , being in fluid communication with the temperature controlled fluid blanket 18 . in a preferred embodiment of the invention , the second ends 144 and 146 of the inflow conduit 58 and outflow conduit 60 are fixedly attached to the blanket 18 . preferably , the inflow and outflow conduits 58 and 60 have a length of between about 4 inches and about 8 inches , and a diameter of between about 0 . 25 inches and about 0 . 75 inches . it is also preferred that the inflow and outflow conduits 58 and 60 are enclosed by a similar layer of insulating material as described above for the intake and output conduits 50 and 52 . the components of the female and male couplers 54 and 56 operate together to provide fluid communication between the intake and output conduits 50 and 52 and inflow and outflow conduits 58 and 60 , respectively , providing a fluid circuit between the reservoir 12 and the blanket 18 . as shown in fig2 and 4 , the female coupler 54 includes a flange 61 , throat 62 , stem 64 , locking member 66 , locking member spring 68 , pin actuator 70 , pin actuator spring 72 , receiving end 74 , throat actuator 76 , throat actuator spring 78 , o - ring 80 , rear wall 81 , apertures 83 , and body 85 . the male coupler 56 includes a throat 82 , stem 84 , throat actuator 86 , throat actuator spring 88 , throat actuator orifices 90 , o - ring 92 , bore 94 , recess 96 , flange 98 , body 100 , actuator o - ring 102 , and rear wall 104 . the stem 64 of each female coupler 54 is inserted into the second ends 136 and 138 of the intake conduit 50 and output conduit 52 . the female coupler 54 is fully seated when the flange 61 lies substantially adjacent to the second ends 136 and 138 of the intake conduit 50 and output conduit 52 , respectively . likewise , the stem 84 of each male coupler 56 is inserted into the first ends 140 and 142 of the inflow conduit 58 and outflow conduit 60 . the male couplers 56 are fully seated when the flange 98 lies substantially adjacent to the first ends 140 and 142 of the inflow conduit 58 and outflow conduit 60 , respectively . as shown in fig2 when the male and female couplers 54 and 56 are uncoupled , the throat actuators 76 and 86 are not actuated , meaning that the throats 62 and 82 of the female and male couplers 54 and 56 are blocked by the throat actuators 76 and 86 . as will be described below , coupling the female coupler 54 with the male coupler 56 actuates both throat actuators 76 and 86 , providing fluid communication between the intake conduit 50 and output conduit 52 and the inflow conduit 58 and outflow conduit 60 . as shown in fig2 when the male coupler 56 is uncoupled from the female actuator 54 , the spring 88 urges the throat actuator 86 away from the throat 82 so that the throat actuator orifices 90 of the male throat actuator 86 are occluded by the body 100 and the actuator o - ring 102 secured to a rear wall 104 of throat actuator 86 ensures that no fluid may be transported between the inflow and outflow conduits 58 and 60 and the bore 94 of the male throat actuator 86 . similarly , when the female coupler 54 is uncoupled , the spring 78 urges the female throat actuator 76 away from the throat 62 so that the receiving end 74 is occluded by the rear wall 81 and o - ring 80 of the female throat actuator 76 and the apertures 83 are occluded by the body 85 of the female coupler 54 , thereby preventing fluid from being transported between the intake and output conduits 50 and 52 and the female coupler 54 . the intake conduit 50 and output conduit 52 and the inflow conduit 58 and outflow conduit 60 are coupled together by releasably connecting each male coupler 56 of the inflow conduit 58 and outflow conduit 60 into each female coupler 54 of the intake conduit 50 and output conduit 52 . as best shown in fig3 when the male coupler 56 is inserted into the receiving end 74 of the female coupler 54 , the throat actuator 86 and body 100 of the male coupler 56 impinges on the throat actuator 76 of the female coupler 54 , thereby compressing throat actuation springs 78 and 88 , allowing the female throat actuators 76 to actuate towards the second ends 136 and 138 of the intake conduit 50 and output conduit 52 and the male throat actuator 86 to actuate towards the first ends 140 and 142 of the inflow conduit 58 and outflow conduit 60 . as the body 100 of each male coupler 56 impinges on the female throat actuator 76 , the female actuators 76 are urged towards the second ends 136 and 138 , the rear wall 81 and o - ring 80 gravitating away from the receiving end 74 and into the wider portion of the throat 62 . additionally , the apertures 83 located on the throat actuator 76 also move into the wider throat 62 creating a fluid pathway between the receiving end 74 and throat 62 of the female coupler 54 . as the male throat actuator 86 impinges on the female throat actuator 76 , the actuator spring 88 compresses and the rear wall 104 and associated actuator o - ring 102 are urged away from the recess 96 allowing the throat actuator orifices 90 to enter into the throat 82 of the male coupler 56 , thereby creating a fluid pathway between the bore 94 of the male throat actuator 86 and the throat 82 of the male coupler 56 . as the body 100 of the male coupler 56 enters the receiving end 74 of the female coupler , the o - ring 92 seals against the body 85 of the female coupler 84 , preventing leakage between the coupled male and female couplers 56 and 54 , respectively . as the male coupler 56 is inserted into the female coupler 54 , the body 100 of the male coupler 56 continues to impel the female throat actuator 76 as the facing surface 106 of the male coupler 56 moves the pin actuator 70 against the force of the pin actuator spring 72 until the notch 108 of the pin actuator 70 is aligned with the slot 110 of the locking member 66 . once the notch 108 of the pin actuator 70 is aligned with slot 110 , the locking member spring 68 expands , releasing locking member 66 from its unlocked position to releasably engage the recess 96 of the male coupler 56 , securing the male coupler 56 to the female coupler 54 , thereby providing fluid communication between the fluid reservoir 12 and blanket 18 . the male coupler and female coupler 56 and 54 are disengaged by depressing the actuating surface 112 of the locking member 66 which compresses the locking member spring 68 , allowing a wide portion of the slot 110 to move towards the pin actuator 70 . the wide portion of the slot 110 is wider than the notch 108 diameter of the actuator pin 70 ( fig4 ). as the pin actuator spring 72 expands , the actuator pin 70 is impelled outward so that a wider portion of the actuator pin 70 engages the wider portion of the slot 110 maintaining the locking member 66 away from the recess 96 of the male coupler , so that the female and male couplers 54 and 56 may now be disengaged . as shown in fig1 the blanket 18 is preferably secured to the second ends 144 and 146 of the inflow and outflow conduits 58 and 60 , respectively . however , alternatively , it may be preferred to utilize a releasable coupler between the inflow and outflow conduits 58 and 60 and the blanket 18 . the shape of the blanket 18 can be designed to accommodate a variety of rehabilitation area configurations . for example , a different shape can be used to treat a head rehabilitation area compared to the shape used to treat a shoulder or knee rehabilitation area . a plurality of elastic straps 114 , including fastening means 116 are used to releasably maintain the blanket 18 adjacent to the area to be rehabilitated . the fastening means 116 are preferably velcro , but male and female snap members are also available . furthermore , according to the present invention , the releasable snap - fit male and female couplers 56 and 54 allow for quick interchangeability of a specific blanket 18 directed to rehabilitating specific areas of a patient . the blanket 18 includes an interior space 118 for circulating hot or cold fluid pumped from the reservoir 12 by the submersible continuously variable pump 17 through the fluid circuit defined by the output conduit 52 , inflow conduit 58 , outflow conduit 60 , intake conduit 50 , pump 17 , reservoir 12 and blanket 18 . it is preferred that the interior space 118 of the blanket 18 forms a plurality of channels 120 for cycling the fluid through the blanket at a rate of between about ¼ gallons / hour and about 10 gallons / hour . blanket 18 is preferably formed of plastic , rubber , and non - woven material . as shown in fig1 the printed circuit board 14 is attached to outer wall 28 of the fluid reservoir 12 . preferably , the circuit board 14 is enclosed by a faceplate 122 , including a reservoir 12 fill indicator means 124 , and a power source connection port 126 . the power source connection port 126 is configured for connecting an alternating current ( ac ) to direct current ( dc ) adapter to an ac power source 42 or , alternatively , a dc power source 42 may be directly connected to the power source connection port 126 via electrical connector 43 . the fill indicator means 124 indicates a fluid fill condition to an operator or user . the fill indicator means 124 may be a dual - mode light , a green signal indicating a no - fill condition and a red signal indicating a fluid fill alert . preferably , the fill indicator means is electrically connected to the control circuit 129 and also to a reservoir sensor 128 located in the interior space of the reservoir 12 ( fig9 ). the sensor 128 may be capable of sensing a plurality of fluid conditions within reservoir 12 , such as the fluid temperature and quantity . in one embodiment , the sensor 128 is a thermistor which is operable to provide a voltage signal to the control circuit 129 proportional to the temperature of the fluid within the reservoir 12 . for a cold therapy application the voltage signal v 00 provided by the sensor 128 is compared to a voltage v refr corresponding to the preferred optimal fluid temperature of between about 35 ° f . and about 55 ° f . within the fluid reservoir 12 . if the sensed temperature is about 55 ° f . or less , the fill indicator means 124 will indicate a no - fill condition . however , if the sensed temperature is greater than about 55 ° f ., the fill indicator means 124 will indicate a fill condition , alerting a user or operator to add more ice or cold fluid to the reservoir 12 . for a hot therapy application the voltage signal v o provided by the sensor 128 is compared to a voltage v refr corresponding to the preferred optimal fluid temperature of between about 95 ° f . and about 110 ° f . within the fluid reservoir 12 . if the sensed temperature is between about 95 ° f . to about 110 ° f ., the fill indicator means will indicate a no - fill condition . however , if the sensed temperature is less than 95 ° f ., the fill indicator means will indicate a fill condition , alerting a user or operator to add more hot fluid to the reservoir 12 . for a device 10 , having an internal refrigeration or heating means within the reservoir 12 , the signal provided by the sensor 128 operates as a control signal , enabling or disabling the refrigeration or heating means . table 1 lists preferred values for the components of fig9 . in an alternative embodiment of the invention , a thermocouple may be used in place of the thermistor as the sensor 128 which is also operable to provide a temperature of the fluid within the reservoir 12 . as described below , the output voltage signal from the thermocouple sensor is proportional to the temperature difference between two wire junctions , 164 and 166 . since the output voltage signal of the thermocouple sensor is proportional to the temperature difference between the two junctions 164 and 166 , the thermocouple sensor cannot provide an absolute temperature indication at the junctions . therefore , by utilizing a cold junction compensation circuit such as thermistor 20 , the signal provided by the thermistor sensor 20 located adjacent to the circuit board 14 changes with and compensates for the changes in the ambient temperature to determine an absolute temperature and output voltage v 00 at junction 164 of the thermocouple ( fig9 ). since the thermocouple is inherently insensitive to water permeation , the thermocouple sensor is operable to provide a reservoir temperature indication signal and / or control signal v 00 which is used as described above without erroneous indications due to fluid permeation . furthermore , an audible signaling device may be used to indicate a fluid fill alert , audibly signaling a fluid fill condition to an operator or user . similarly , a fluid level indicator and temperature indicator may be used to alert the operator to the fluid conditions within the reservoir 12 . preferably , the circuit board 14 is disposed between the outer wall 28 and interior wall 24 of the fluid reservoir 12 so that the fluid within reservoir 12 does not come into contact with the circuit board 14 . that is , it is preferred that the circuit board 14 is maintained in a dry state , ensuring the operability of the electrical connections of the board 14 . the wires 40 connecting the circuit board to the pump 17 pass through an aperture formed in the interior wall 24 of the reservoir 12 , and a sealant or gasket is used around the wires 40 at the point where they pass through the aperture for preventing fluid from entering the space between the interior wall 24 and exterior wall 28 , where the circuit board 14 is located . according to a preferred embodiment of the invention , two sensors 20 and 22 are utilized to determine a control signal , which controls the operation of the submersible pump 17 . preferably , when a dc or ac power source 42 is connected to the power source connector port 126 a voltage is always applied to the submersible pump 17 via the conducting wires 40 . the power provided to the submersible pump 17 is based on the control signal determined from the output of sensors 20 and 22 . preferably , sensor 20 is a thermistor type sensor having a variable resistance of between about 1 , 000 ohms and 10 , 000 ohms . the resistance of a thermistor type sensor varies exponentially according to the surrounding temperature and is operable to output an absolute temperature reading . as shown in fig1 the thermistor sensor 20 is adjacently located to the circuit board 14 , and similarly protected between the interior wall 24 and exterior wall 28 as the circuit board 14 from potential fluid permeation . it is preferable to maintain the thermistor sensor 20 in a “ dry ” state since fluid permeation impinging on the thermistor sensor 20 may tend to cause the thermistor sensor 20 to provide an erroneous absolute temperature signal . for a cold fluid therapy device , it is preferable to maintain the fluid within a desired temperature range so that maximal beneficial results are seen at the treatment area of a user or patient . according to the invention , to obtain an accurate blanket 18 temperature reading , it is preferable to sense the temperature of the fluid circulating through the blanket 18 as close as possible to the blanket 18 . preferably , the fluid temperature is sensed at a location adjacent to the second end 136 of the intake conduit 50 which when connected to the outflow conduit 60 tends to give a close approximation of the temperature of the fluid circulating through the blanket 18 . therefore , it is preferred to use a sensor which tends to be impervious to fluid permeation , such as a thermocouple sensor 22 . the thermocouple sensor 22 is preferably a t - type thermocouple ( constantan member 148 and copper member 150 ( fig6 )), but a k - type thermocouple consisting of a chromell member and alumel member , or other types of temperature sensors , are also viable sensors . accordingly , the thermocouple sensor 22 includes a cold junction 152 and a hot junction 154 , and the output signal from the thermocouple sensor 22 is proportional to the temperature difference between the cold and hot junctions 152 and 154 , respectively . since the output signal of the thermocouple sensor 22 is proportional to the temperature difference between the cold and hot junctions 152 and 154 , the thermocouple sensor 22 cannot provide an absolute temperature indication at junctions 152 or 154 . by utilizing the absolute ( compensating ) temperature signal provided by the thermistor sensor 20 , it is possible to determine the absolute temperature at junction 154 of the thermocouple sensor 22 . according to a preferred embodiment of the invention , the cold junction 152 of the thermocouple sensor 22 is adjacently located to the thermistor sensor 20 on the circuit board 14 . an approximate temperature of the cold junction 152 of the thermocouple sensor 22 may be determined by locating the cold junction 152 of the thermocouple sensor 22 adjacent to the thermistor sensor 20 since the thermistor sensor 20 is providing an absolute temperature signal . as described above , the thermocouple sensor 22 provides a signal proportional to the temperature difference between the cold and hot junctions 152 and 154 . therefore , by utilizing the sensed thermistor sensor 20 signal to determine approximately the cold junction 152 temperature , the hot junction 154 temperature is determined by subtracting the cold junction 152 temperature from the sensed temperature difference of the thermocouple sensor 22 , providing a temperature of the hot junction 154 . fig7 depicts a preferred embodiment for the location of the hot junction 154 of the thermocouple sensor 22 . as shown , the thermocouple 22 is preferably located between the insulating layer 53 and the fluid conduit 16 . the thermocouple 22 extends from the cold junction 152 adjacently located to the circuit board 14 to the hot junction 154 , which preferably penetrates through an orifice 160 into the intake conduit 50 . preferably , the aperture 160 and hot junction 154 are located adjacent to the second end 136 of the intake conduit 50 . it is preferred that the orifice 160 is sealed around the sensor 22 by using epoxy , or sealant . accordingly , by locating the hot junction 154 of the thermocouple sensor 22 adjacent to the second end 136 of the intake conduit 50 and thereby adjacent to the first end 142 of the outflow conduit 60 of the blanket 18 , an approximate temperature of the fluid within the blanket 18 may be determined due to the proximity of the hot junction 154 with respect to the fluid exiting the blanket 18 . correspondingly , the device 10 provides hot or cold fluid therapies to a user without the concern of erroneous temperature readings due to water permeation of the thermocouple sensor 22 , since the thermocouple 22 is substantially insensitive to water permeation . in another embodiment of the invention , the hot junction 154 of thermocouple sensor 22 does not penetrate the intake conduit 50 , but is instead located between the fluid conduit 16 and the insulating layer 53 . accordingly , it is still possible to obtain an accurate approximation of the fluid temperature within the blanket 16 , however , there may be a slight delay in sensing the actual fluid temperature due to the material properties of the fluid conduit 16 . therefore , for this latter sensor configuration , a ‘ warm - up ’ time may be necessary to achieve an appropriate fluid temperature determination . since the temperature of the fluid flowing throughout the temperature controlled fluid therapy device 10 is in constant flux , the hot junction 154 temperature will vary correspondingly . therefore , it is possible to regulate the temperature of the fluid within device 10 by using the varying hot junction temperature as an input to a control circuit 129 . referring to fig5 the control circuit 129 utilizes the thermistor sensor 20 and thermocouple sensor 22 signals to generate a control signal which is input to a calibrated pulse width modulator 130 . more particularly , and with additional reference to fig6 the control circuit 129 generates an output voltage v 0 which varies according to the fluctuating fluid temperature . table 2 lists preferred values for the circuit components of the control circuit 129 for a cold therapy device 10 . according to the invention , the varying voltage v o is compared to the reference voltage v ref and the result is used to control the pulsewidth of a pulse output from the voltage controlled pulse width modulator 130 . for a cold therapy device the reference voltage v ref corresponds to a set - point temperature of between 35 ° f . and about 55 ° f . the voltage v o is proportional to a function of the cold junction temperature ( thermistor signal ) plus another function of the temperature difference between the hot and the cold junctions 154 and 152 ( thermocouple signal ), respectively . additionally , for a hot fluid therapy application , the control circuit 129 utilizes a set point temperature of the fluid of between about 95 ° f . and about 110 ° f ., essentially comparing the hot junction 154 temperature with the set point temperature to generate a control signal which is input to the pulse width modulator 130 . accordingly , the pulse width modulator 130 utilizes the control signal output from the control circuit 129 to modulate the width of a pulse which is used to control the operation of the pump 17 . more specifically , the duty cycle of the pulse width modulated signal is continuously varying according to the varying temperature of the fluid at the hot junction 154 of the thermocouple sensor 22 . the varying pulse duty cycle output from the calibrated pulse width modulator 130 controls the average power delivered to the submersible pump 17 via power source 42 , therefore controlling the speed of the continuously variable submersible pump 17 . the pulse width modulator 130 is calibrated to vary the duty cycle of the pulse based on the control signal output from the control circuit 129 . for example , when the control circuit 129 determines that the hot junction 154 temperature of the thermocouple is about equal to the set point temperature , the control circuit 129 sends a corresponding control signal to the pulse width modulator 130 . in response , the pulse width modulator 130 modulates the pulse width modulated signal such that pump 17 is operating at about the mid - range of between about ¼ gallons / hour and about 10 gallons / hour . depending on the application of the temperature controlled fluid therapy device 10 , that is , cold or hot fluid therapy applications , the control signal output from the control circuit 129 is controlled accordingly . for a cold fluid therapy application , as the hot junction 154 temperature increases , the control signal output from the control circuit 129 will vary correspondingly and the duty cycle of the pulse output from the pulse width modulator 130 will increase , causing the pump rate to increase which correspondingly increases the flow of cool fluid flowing from within reservoir 12 to the blanket 18 . if the temperature at the hot junction 154 decreases below the set point temperature , the duty cycle of the pulse will correspondingly decrease , to a point where the pump 17 is nearly stopped . however , as described above , preferably there is always power applied to the pump 17 , the duty cycle of the pulse output from the pulse width modulator varying the supplied power according to the hot junction temperature 154 . on the other hand , for a hot fluid therapy application , as the hot junction 154 temperature decreases , the control signal output from the control circuit 129 will vary correspondingly and the duty cycle of the pulse output from the pulse width modulator 130 will increase , causing the pump rate to increase which correspondingly increases the flow of hot fluid flowing from within reservoir 12 to the blanket 18 . in an alternative embodiment of the invention , it is preferable to control the fluid temperature within the blanket 18 based on the skin temperature of the individual using the device 10 . research has determined the point at which neurons in the skin begin reactivating . therefore , it would be preferable to measure the skin temperature to control the neuron firing . accordingly , a thermistor sensor 156 is adjacently located to the blanket 18 ( fig8 ). the thermistor sensor 156 is connected to the circuit board 14 via electrical connector 158 . the electrical connector 158 is preferable an insulated conductor , such as insulated copper wire , and may be contained between the insulating layer 53 and the conduit 16 , or alternatively , the connector 158 may be externally located with respect to the insulating layer 53 . the electrical connector 158 preferably includes a coupling 159 , which allows the connector 158 to be disconnected when it is desired to disconnect the blanket 18 from the fluid conduit 16 . in this embodiment of the invention , the thermocouple sensor 22 is not a necessary component of device 10 for measuring the temperature of the blanket 10 . depending on the particular blanket 18 , the thermistor 156 is preferably located directly adjacent to the rehabilitation area , obtaining the most accurate skin temperature when the blanket 18 and fluid are applied to the individual . in this embodiment , since the thermistor 156 is at a location where there is no potential water contamination , an absolute temperature indication of the skin is available without the possibility of erroneous measurements due to fluid permeation of the thermistor 156 . the control circuit 129 compares the thermistor 156 signal to a reference voltage v ref , inputting the result to the pulse width modulator 130 . the pulse width modulator 130 varies the duty cycle of the pulses according to the result , controlling the operation of the pump 17 , as discussed previously . according to the invention , since the pump 17 speed varies based on the duty cycle of the pulse output from the pulse width modulator 130 , the frequency of the pulses is not a controlling factor . however , the armature of the pump 17 tends to vibrate at the frequency of the pulse width modulated signal , and signal frequencies in the audible range (& lt ; 20 khz ) tend to make for a noisy pump . according to a preferred embodiment of the invention , the frequency of the pulses output from the pulse width modulator 130 is adjusted by modulation above the audible range (& gt ; 20 khz ), tending to provide a quieter temperature controlled fluid therapy device 10 . once the intake conduit 50 and output conduit 52 and the inflow conduit 58 and outflow conduit 60 are connected , a patient may now utilize the temperature controlled fluid therapy device 10 to treat an injured or sore area by applying the blanket 18 thereto . depending on the application , hot or cold fluid therapy , the fluid reservoir is filled with hot or cold fluid via fill port 30 . the user can place the blanket over the treatment area before or after a dc or an ac power source is plugged into the power source connection port 126 , immediately providing power to the pump 17 . as described above , the control circuit 129 utilizing sensors 20 and 22 automatically regulates the amount of hot or cold fluid flowing to the blanket 18 . if the hot or cold fluid within reservoir 18 drops below or above a preferred fluid temperature , the fill indicator means 124 will communicate the condition to the user or operator , who may then add hot or cold fluid to the reservoir 12 ( fig1 ). it is contemplated , and will be apparent to skilled in the art from the preceding description and the accompanying drawings , that modifications and changes may be made in the embodiments of the invention . for example , the intake and output conduits 50 and 52 and inflow and outflow conduits 58 and 60 can be one continuous piece , that is , not including the male and female couplers 54 and 56 . also , the pump can be externally located from the reservoir 12 controlling the flow of fluid from the reservoir 12 to the blanket 18 . additionally , reservoir 12 can contain refrigeration and / or heating capability and related circuitry for automatically regulating the temperature of the fluid within reservoir 12 . moreover , a fluid fill line and drain line can be attached to a fluid fill port and drain port on reservoir 12 which automatically fills reservoir 12 with hot or cold fluid upon a sensed level / temperature condition of reservoir 12 , draining fluid as new fluid is added to reservoir 12 . accordingly , it is expressly intended that the foregoing description and the accompanying drawings are illustrative of preferred embodiments only , not limiting thereto , and that the true spirit and scope of the present invention be determined by reference to the appended claims .

US-77102501-A

according to one embodiment , an apparatus for mating a first instrument having an image sensor to a second instrument includes : a coupler having first and second ends respectively adapted to mate with the first and second instruments ; a sheath , mounted to the coupler , that is extendable to accommodate at least one portion of the first instrument when the first instrument is mated with the first end of the coupler ; and a focusing mechanism to focus light onto the image sensor , the focusing mechanism being uncovered by the sheath when the first end of the coupling device is mated with the first instrument and the sheath is extended to accommodate the at least one portion of the first instrument . according to another embodiment , an apparatus for mating with an imaging - producing scope includes : an imaging unit including an image sensor and a lens ; and a coupler having first and second ends , the first end being adapted to mate with the imaging unit and the second end being adapted to mate with the scope . according to another embodiment , a method for mating a sterile instrument with a non - sterile instrument while maintaining a sterile barrier therebetween includes the steps of : using a sterile coupling device having a sterile sheath attached thereto to mate the sterile instrument with the non - sterile instrument by mating a first portion of the sterile coupling device with the sterile instrument and a second portion of the sterile coupling device with the non - sterile instrument ; and extending the sterile sheath to at least partially accommodate the non - sterile instrument .

applicant has recognized numerous drawbacks of prior art coupling devices and the imaging systems in which they are used . a brief discussion of two of these drawbacks follows with reference to fig1 . a first drawback is that the portion of the condom - like sheath 5 that intersects the optical axis 17 of the image sensor 14 can interfere with the quality of the image generated on the monitor 46 . the condom - like sheath 5 is typically formed of pliable material that can wrinkle in front of lens 20 , thereby causing the image generated by image sensor 14 to be distorted . some prior art systems form the window 7 out of a stiffer material that is less likely to wrinkle . nevertheless , it can be difficult to properly align the window 7 in front of the lens 20 when sandwiching the sheath 5 between the endoscope 16 and the coupling device 8 . a second drawback is that the sheath 5 is draped over the coupling device 8 and the focusing mechanism 11 located thereon . thus , the user must manipulate the focusing mechanism 11 through the material of sheath 5 . this makes it difficult for the user to precisely adjust the focal length between the image sensor 14 and lens 20 to achieve a sharp image on the monitor 46 , and makes the sheath 5 susceptible to tearing due to manipulation of the focusing mechanism . one exemplary embodiment of the invention discussed below in connection with fig2 - 4 overcomes each of the above - mentioned drawbacks . however , it should be appreciated that the present invention is not limited in this respect , and that alternate embodiments of the invention are contemplated that separately overcome either of these drawbacks . furthermore , it should be understood that the illustrated embodiment of the present invention also has numerous other advantages . fig2 is a partially cut away perspective view of an imaging system according to one embodiment of the invention . as shown , the imaging system includes four primary components , i . e ., an endoscope 16 , an imaging unit 10 , a coupling device 12 , which couples the endoscope 16 to the imaging unit 10 , and a condom - like sheath 40 , which prevents the imaging unit 10 from contaminating the sterile operating field . the imaging system can be employed with any type of image - producing scope , and is not limited to use with any particular type of scope . as discussed in more detail below , in the exemplary imaging system shown in fig2 - 3 , the condom - like sheath 40 does not intercept the optical viewing axis of the system , thereby overcoming a number of the problems experienced in the prior art system of fig1 . in addition , the condom - like sheath 40 does not cover a focusing mechanism 48 of the imaging system , making it easier to focus the system and lessening the likelihood that the sheath 40 will be damaged due to manipulation of the focusing mechanism . another significant difference between the embodiment of fig2 - 3 and the prior art system of fig1 is that the lens for focusing the image from the endoscope to the imaging unit is provided in the imaging unit 10 , rather than in the coupling device 12 . this is particularly advantageous because , as discussed in more detail below , in the exemplary embodiment shown , a portion of the coupling device 12 is not separated from the endoscope 16 by the condom - like sheath 40 , and therefore , is sterile in use . by removing the focusing lens 20 from the coupling device 12 , the coupling device 12 can be made significantly less expensively , thereby enabling the coupling device 12 to be provided as a disposable part that need not be sterilized between uses . this is advantageous because the sterilization of the devices can be inconvenient and time consuming . in the embodiment shown in fig2 - 3 , the imaging unit 10 includes an image sensor 14 that is similar to that employed in the prior art system of fig1 and that senses an image along an imaging axis ( not shown ). as with the prior art system of fig1 when the imaging system is used , the coupling device 12 is coupled between the eyepiece 36 of the endoscope 16 and a distal end 66 of the imaging unit 10 such that the lens 20 is disposed between the image sensor 14 and the eyepiece 36 to focus an image produced by the endoscope 16 onto the image sensor 14 . however , in contrast to the prior art system of fig1 the lens 20 is provided in the imaging unit 10 , rather than in the coupling device 12 . as discussed above , this is advantageous because the coupling device can be made significantly less expensively , thereby enabling the coupling device to be provided as a disposable part that need not be sterilized between uses . the image sensor 14 may , for example , include a charge - coupled device ( ccd ) or a metal - oxide semiconductor ( mos ) sensor . it should be appreciated , however , that the present invention is not limited in this respect , and can be employed with any type of image sensor 14 . the image generated by the image sensor 14 can be conveyed to a monitor 46 in any of numerous ways , and the present invention is not limited to any particular implementation . for example , the image sensor 14 may be coupled to circuitry 56 which can assist in converting an image sensed by the image sensor 14 into an electrical signal . this electrical signal then may be transmitted ( e . g ., via cable 26 ) to the monitor 46 for display to a user or may be otherwise processed and / or recorded on a suitable medium . alternatively , the image sensor 14 may comprise a bundle of fiber optic cables which optically transmit an image from the lens 20 to a viewing device for display to a user . thus , the image sensor 14 need not necessarily convert the image from endoscope 16 into an electrical signal . in the embodiment shown in fig2 the imaging unit 10 is releasably mated with the coupling device 12 . this mating may be accomplished using any of a number of techniques , and the invention is not limited to any particular mating technique . fig2 and 3 , however , illustrate one technique that may be used to mate these two components . in the particular embodiment shown , to mate imaging unit 10 with coupling device 12 , a distal end 66 of the imaging unit 10 is inserted into an opening 88 at a proximal end 110 of the coupling device 12 . as shown , the imaging unit 10 includes a button 58 which is pivotally connected , via a pin 82 , to a body portion 18 of the imaging unit 10 . the imaging unit 10 has a cavity 81 formed underneath the button 58 and a spring 90 , disposed in the cavity 81 . spring 90 biases the button 58 ( in a clockwise direction in fig2 ) about pin 82 so that locking member 60 is biased away from a surface 86 of body portion 18 . when a user pushes button 58 toward surface 86 , however , spring 90 is compressed so that button 58 moves in a counterclockwise direction in fig2 about pin 82 and locking member 60 moves toward surface 86 . thus , when the button 58 is depressed and the distal end 66 of the imaging unit is inserted into the opening 88 in the coupling device 12 , the locking member 60 moves toward surface 86 so that it can slide over edge 118 of the coupling device 12 . when the button 58 is released , the locking member 60 is biased ( by spring 90 ) away from surface 86 and into a notch 62 in the coupling device 12 , and a shoulder 116 of imaging unit 10 contacts a shoulder 114 of the coupling device 12 , thereby interlocking the imaging unit 10 and the coupling device 12 . an indication that the distal end 66 of the imaging unit 10 is fully inserted into the opening 88 is provided by the distal end 66 contacting a shoulder 112 of coupling device 12 . the imaging unit 10 and coupling device 12 can be separated by pushing button 58 , which moves the locking member 60 out of the notch 62 , and pulling the imaging unit 10 away from the coupling device 12 . as mentioned above , fig2 - 3 illustrate only one example of the many ways that the imaging unit 10 and coupling device 12 may be mated together , and the present invention is not limited to this or any other particular implementation . in the embodiment shown in fig2 and 3 , the imaging unit 10 also includes a handle 78 proximal to the body portion 18 . the handle 78 may include grooves 80 to make it easier for a user to grip the imaging unit 10 though the sheath 40 that can be extended over the imaging unit 10 in a manner described below . the image sensor 14 and circuitry 56 may be mounted in the body portion 18 of the imaging unit 10 in any of a number of ways . for example , the image sensor 14 may be mounted via pins or screws 84a and 84b , and circuitry 56 may be mounted on a circuit board supported within body portion 18 . one or more wires ( not shown ) may be used to interconnect the circuitry 56 with the cable 26 . as discussed above , it is useful to enable the focal length between the image sensor 14 and the lens 20 of imaging unit 10 to be adjusted . in accordance with one exemplary embodiment of the invention , this can be accomplished via a mechanism that is not covered by the condom - like sheath 40 , thereby making it easier to focus the system and lessening the likelihood that the sheath 40 will be damaged due to manipulation of the focusing mechanism . it should be appreciated , however , that the present invention is not limited in this respect , and that the focal length adjustment can be accomplished in any number of ways . one example of a technique that is useful to perform the focal length adjustment is illustrated in fig2 - 4 . in the embodiment shown , the lens 20 is disposed in the imaging unit 10 , rather than in the coupling device 12 . thus , the focusing mechanism includes elements disposed in the imaging unit 10 , as well as in the coupling device 12 . as mentioned above , placement of the lens 20 within the imaging unit 10 , rather than in the coupling device 12 , provides at least one significant advantage . that is , according to such an embodiment , the cost of the coupling device 12 may be reduced significantly below the cost of coupling devices that include lenses , thereby making it commercially practicable to use a new , sterile coupling device each time the imaging system is used , rather than repeatedly sterilizing and reusing the same coupling device . in the particular embodiment shown , the distal end 66 of the imaging unit 10 includes a primary cylinder 76 , in which a spring 68 and a cylindrical lens holder 22 are disposed . lens holder 22 supports the lens 20 in front of an imaging axis of image sensor 14 . lens holder 22 ( and lens 20 ) can be moved within primary cylinder 76 either toward or away from distal end 66 of the imaging unit 10 so as to adjust the focal length between the image sensor 14 and the lens 20 . spring 68 biases lens holder 22 toward distal end 66 . the position of lens holder 22 within primary cylinder 76 can be adjusted , however , through manipulation of a focusing mechanism on the coupling device 12 as discussed below . the imaging unit 10 further includes an outer cylinder 72 , including a spirally ramped upper edge 96 , which surrounds the primary cylinder 76 . outer cylinder 72 is movable with respect to primary cylinder 76 either toward or away from the distal end 66 of imaging unit 10 . outer cylinder 72 is connected to the lens holder 22 via a pin 70 . pin 70 extends through a slot 92 which extends a short distance along a length of the primary cylinder 76 . thus , in the embodiment shown , lens holder 22 , outer cylinder 72 and pin 70 move as a single unit , with respect to primary cylinder 76 , either toward or away from the distal end 66 of imaging unit 10 . the manner in which this unit interacts with the focusing mechanism disposed on coupling device 12 is described below in connection with fig4 a - b . fig2 and 3 show an exemplary embodiment of the coupling device 12 . the coupling device 12 can be constructed in any of a number of ways to achieve the desired goal of enabling the imaging unit 10 to be coupled to the endoscope 16 , and the present invention is not limited to the particular implementation shown in the figures . in the embodiment shown , the coupling device 12 includes a main body 50 ( including a proximal portion 50a and a distal portion 50b ), a focusing ring 48 , a light - penetrable window 94 , a scope mounting portion 42 ( including inner ring 42a and outer ring 42b ) and the condom - like sheath 40 . the components constituting the main body 50 , focusing ring 48 and scope - mounting portion 42 may be made of any suitable material and may be affixed together in any suitable manner . for example , they may be plastic molded components affixed together using an epoxy - based adhesive . for the embodiment of the invention wherein the coupling device 12 is a disposable device , the coupling device 12 is preferably formed from inexpensive components . the main body 50 may be formed by inserting the distal portion 50b within the focusing ring 48 , and then affixing together the proximal and distal portions 50a and 50b . scope mounting portion 42 may be affixed to distal portion 50b . main body 50 has an outer surface 52 between a distal end 108 and a proximal end 10 of the coupling device 12 . a channel 44 extends about a perimeter of the outer surface 52 between the focusing ring 48 and the proximal end 110 . when the coupling device 12 is used in a medical application , it is generally important that the environment to which the patient is exposed remains sterile . it is also desirable , however , to not have to sterilize the imaging unit 10 , thereby saving the time and expense of sterilization , and avoiding restrictions on the manner in which the imaging unit be formed , since it need not be sterilizable . therefore , in accordance with one embodiment of the present invention , a sterile barrier is established between the sterile operating environment including the endoscope 16 , and a non - sterile environment including the imaging unit 10 . in one embodiment of the invention , such a sterile barrier is established by coupling the distal end 66 of the imaging unit 10 to the coupling device 12 , and providing a hermetic seal between the components of the coupling device 12 that separate the sterile and non - sterile environments . in the embodiment shown in the figures , a light - penetrable window 94 is hermetically sealed between the distal end 108 and the proximal end 110 of the coupling device 12 to establish a sterile barrier therebetween . window 94 may be made of glass , plastic , or any other suitable material through which light can pass from the endoscope 16 to the image sensor 14 ( via lens 20 ) to generate a suitable image . as mentioned above , the coupling device 12 also includes the condom - like sheath 40 . the condom - like sheath 40 may be made of any material that is suitable for creating a sterile barrier between a sterile environment and a non - sterile environment . for example , according to one embodiment , the condom - like sheath may be made of a non - porous latex or plastic material . when the imaging unit 10 is mated with the coupling device 12 , the sheath 40 may be extended to cover some or all of imaging unit 10 and cable 26 ( fig2 ). the condom - like sheath 40 may be hermetically sealed to the outer surface 52 of coupling device 12 . it should be appreciated that in the embodiment shown in the figures , when each of the components of the coupling device 12 is sterile , the hermetic seals between the main body portion 50 and the window 94 and sheath 40 establish a sterile barrier between the endoscope 16 and the imaging unit 10 , with the main body portion 50 of the coupling device 12 itself forming a part of this sterile barrier . as compared to the prior art system shown in fig1 in which a sterile barrier is formed only with the sheath 5 and the window portion 7 thereof and in which the coupling device 8 is located entirely on the non - sterile side of this barrier , the embodiment shown in fig2 - 3 is superior because endoscope 16 can mate directly with body portion 50 rather than requiring the sheath to be interposed between the coupling device and the endoscope as was done in the prior art . this feature therefore overcomes the drawbacks of the prior art system described above regarding the impact of the sheath of the quality of the image produced by the system , and the difficulty of properly sandwiching the sheath between the coupling device and the endoscope . according to one embodiment of the present invention , the condom - like sheath 40 does not intercept the optical viewing axis 19 of the imaging system . as mentioned above , this is advantageous in that the sheath 40 need not be provided with a window that must be aligned with the optical viewing axis 19 , and the sheath 40 does not interfere with the quality of the image presented on the monitor 46 . it should be appreciated that the function performed by the condom - like sheath 40 can be achieved in any of numerous ways , and that the present invention is not limited to any particular implementation . for example , a protective sheath can be provided that is more rigid than the condom - like sheath 40 depicted in the drawings in the embodiment shown in the drawings , the condom - like sheath 40 is substantially tubular in form and is open on its distal and proximal ends . the distal end 21 of the condom - like sheath 40 is attached to the outer surface 52 ( within channel 44 ) of the coupling device 12 . as discussed above , in one embodiment of the present invention , this attachment can be accomplished using a hermetic seal ( e . g ., via an o - ring 54 ) to maintain the separation between the sterile and non - sterile environments . the condom - like sheath 40 can be provided in a rolled - up form attached to the coupling device 12 . after the coupling device 12 is mated with to the imaging unit 10 as described above , the condom - like sheath 40 can be unrolled to cover the non - sterile imaging unit 10 . by encompassing the outer surface 52 of coupling device 12 with the opening at the distal end 21 of the sheath 40 , the sheath 40 can be used in conjunction with coupling device 12 without requiring the user to align the sheath 40 , or a window portion thereof , between the eyepiece 36 of the endoscope 16 and the coupling device 12 , and without having the sheath 40 intercept the optical viewing axis 19 of the imaging system . fig2 and 3 illustrate one example of a technique that may be used to mate the endoscope 16 with the coupling device 12 . it should be appreciated that the invention is not limited in this respect , and that numerous other suitable mating techniques can be employed . in the embodiment shown in fig2 and 3 , the endoscope 16 is mated with the coupling device 12 by inserting the eyepiece 36 into an opening 38 at the distal end 108 of the coupling device 12 . opening 38 may be formed by the inner and outer rings 42a - b of the scope mounting portion 42 . in the embodiment shown , the inner and outer rings 42a - b form equal diameter openings , and inner ring 42a is movable with respect to outer ring 42b . a spring biases the inner ring 42a so that its center is forced to be offset from the center of the outer ring 42b unless a user activates a lever ( not shown ) to cause the centers of the two rings to align with one another . to mate the endoscope 16 with the coupling device 12 , the user activates the lever so that the centers of the rings 42a - b align with one another and inserts the eyepiece 36 through both rings . the user then can release the lever so that the spring ( not shown ) causes the center of ring 42a to become offset from the center of ring 42b . because the diameter of the eyepiece 36 is only slightly smaller than the diameter of each of rings 42a and 42b , when the centers of the rings are offset from one another , the eyepiece 36 will be locked within the scope mounting portion 42 of the coupling device 12 . the eyepiece 36 may be separated from the scope mounting portion 42 by pressing the lever to realign the centers of rings 42a and 42b and pulling the endoscope 16 away from the coupling device 12 . as discussed above , according to one embodiment of the invention , the user can directly manipulate a focusing mechanism without having to do so through a portion of a protective sheath such as condom - like sheath 40 . the present invention is not limited to use with any particular type of focusing mechanism , as any mechanism can be employed that serves to adjust the focal length between the lens 20 and image sensor 14 in the imaging unit 10 . in the exemplary embodiment of the invention shown in fig2 - 4 , a focusing ring 48 is provided on the coupling device 12 to perform this focal length adjustment . the focusing ring 48 is disposed distally of the distal end 21 of the condom - like sheath 40 , so that after the sheath 40 is extended to cover some or all of the imaging unit 10 and cable 26 ( fig2 ), the focusing ring 48 is not covered by the sheath 40 and may be manipulated by a user to adjust the focal length between the lens 20 and the image sensor 14 without also having to manipulate the sheath 40 . hence , this feature makes focusing ring 48 relatively easy for the user to manipulate to achieve sharp focusing , and reduces the risk of damage to sheath 40 . an illustrative example of a linkage assembly for mechanically coupling the focusing ring 48 on the coupling device 12 to the imaging unit 10 to adjust the focal length between the lens 20 and image sensor 14 is shown in fig3 and 4a - b . it should be appreciated that the present invention is not limited to this particular linkage assembly , as numerous other implementations are possible . in the embodiment shown , the distal portion 50b of the main body portion 50 of coupling device 12 has an annular groove 100 . annular groove 100 may be covered by the focusing ring 48 , so that it is not visible from the outside of coupling device 12 . a finger 98 extends inwardly from the focusing ring 48 through the annular groove 100 , so that when the focusing ring 48 is rotated about the main body portion 50 , finger 98 slides within the annular groove 100 . as shown in fig4 a - b , when the imaging unit 10 is mated with the coupling device 12 , a lower surface 120 of finger 98 contacts a portion of a spiraling ramp surface 96 on the outer cylinder 72 . as mentioned above , pin 70 may be connected between the outer cylinder 72 and the cylindrical lens holder 22 through the slot 92 , which extends along the length of the primary cylinder 76 , so that the outer cylinder 72 and lens holder 22 do not rotate with respect to the primary cylinder 76 . the focusing ring 48 , however , can rotate freely about the primary cylinder 76 , limited only by the movement of the finger 98 within the annular groove 100 . as the focusing ring 48 rotates with respect to the primary cylinder 76 , a bottom surface 120 of the finger 98 slides along the spiraling ramped surface 96 . the spring 68 pushes upwardly on outer cylinder 72 to keep a portion of the spiraling ramped upper surface 96 in contact with bottom surface 120 of the finger 98 at all times . enough friction exists between the focusing ring 48 and the main body 50 of the coupling device 12 to prevent the spring 68 from rotating the focusing ring 48 when it is not being manipulated by a user . this friction makes the fine tuning of the focal length between the lens 20 and image sensor 14 ( using focusing ring 48 ) relatively easy to accomplish . fig4 a and 4b illustrate the focusing mechanism at its two extreme focusing positions , with fig4 a illustrating the lens 20 at its closest position to the image sensor 14 and fig4 b illustrating the lens 20 at its furthest position from the image sensor 14 . as shown in fig4 a , when the lens 20 is at its closest position to the image sensor 14 , the spring 68 is fully compressed , bottom surface 120 of finger 98 is in contact with a point 106 near the top of the spiraling ramped surface 96 , and the finger 98 is in a first position with respect to the primary cylinder 76 . in contrast , as shown in fig4 b , when the lens 20 is at its furthest position from the image sensor 14 , the spring 68 is fully extended , the bottom surface 120 of finger 98 is in contact with a point 104 near the bottom of the spiraling ramped surface 96 , and the finger 98 is in a second position with respect to the primary cylinder 76 , which is on an opposite side from the first position ( fig4 a ). it should be appreciated that the present invention is not limited to the above - described system for adjusting the focal length between the image sensor 14 and the lens 20 . this implementation is only one example of the many possible systems that can achieve this result , as other implementations can alternatively be employed . having thus described at least one illustrative embodiment of the invention , various alterations , modifications and improvements will readily occur to those skilled in the art . such alterations , modifications and improvements are intended to be within the spirit and scope of the invention . accordingly , the foregoing description is by way of example only and is not intended as limiting . the invention is limited only as defined in the following claims and the equivalents thereto .

US-6445298-A

the present invention is directed toward an antimicrobial hand sanitizing lotion in the form of a medicated polymer / emulsion based product and the method by which it is produced . the product is intended to be used as a topical antimicrobial and skin protective lotion and contains 2 , 4 , 4 ′- trichloro - 2 ′- hydroxydiphenyl ether as the antimicrobial agent of choice in a base which forms a hydrophobic protective barrier , having persistent antimicrobial properties , upon application to the skin .

production of the antimicrobial sanitizing lotion of the present invention relies upon strict adherence to a particular set of process parameters in order to arrive at a unique final product . in carrying out the process , particular attention must be given to the order of addition of the various components . additionally , it is necessary that rigorous homogenization be carried out to form a “ grain ” free product . finally , the various steps must be carried out within particular temperature ranges which are critical to the outcome of the process . the product contains , as its active ingredient , triclosan ( a class iii topical antimicrobial active ingredient . the finished product strength for triclosan ranges from ( all percentages are percent by weight ) 0 . 10 % - 0 . 35 %, with a particularly preferred range being 0 . 117 %- 0 . 143 % for general and food service usage and 0 . 27 %- 0 . 33 % for the health care environment . the product is a viscous , flowing liquid polymer emulsion which is opaque and white in color , having a mild characteristic odor . the specific gravity of the product ranges from 0 . 960 - 0 . 980 at 25 ° c . and the ph of a 10 % by volume aqueous solution is within the range of 6 . 5 - 7 . 1 . the excipients which are useful in forming the antimicrobial and skin protective lotion of the present invention are deionized water , in a range of 75 - 85 wt . %, versene - 100 , in a range of 0 . 136 - 0 . 184 wt . %, carbopol 934 - p in a range of 0 . 245 - 0 . 455 wt . %, triton x - 100 in a range of 2 . 55 - 3 . 45 wt . %, propylene glycol u . s . p . in a range of 0 . 85 - 1 . 15 wt . %, tergitol np - 9 in a range of 1 . 7 - 2 . 3 wt . %, dowcide - a , in a range of 0 . 10 - 0 . 50 wt . %, triethanolamine 85 % n . f , in a range of 0 . 85 - 1 . 15 wt . %, chlorhexidine digluconate 20 %, in a range of 0 . 16 - 0 . 75 wt . %, alpha tocopherol ( vitamin e u . s . p . ), in a range of 0 . 09 - 0 . 11 wt . %, stearic acid — triple pressed in a range of 2 . 55 - 3 . 45 wt . %, cetyl alcohol n . f ., in a range of 1 . 35 - 1 . 65 wt . %, ethylene glycol monostearate , in a range of 0 . 675 - 0 . 825 wt . %, dimethicone 1 - 45 - 350 cstks , in a range of 1 . 7 - 2 . 3 wt . %, u . s . p . white wax in a range of 0 . 213 - 0 . 288 wt . %, and paragon mepb in a range of 1 . 0 - 3 . 0 wt . %. the following formulation was produced in accordance with the instant invention . excipients useful in the manufacture of this product were added in the following amounts : excipient % by weight ( 1 ) deionized water 83 . 50 ( 2 ) versene - 100 0 . 16 ( 3 ) carbopol 934 - p 0 . 35 ( 4 ) triton x - 100 3 . 00 ( 5 ) propylene glycol u . s . p . 1 . 00 ( 6 ) tergitol np - 9 2 . 00 ( 7 ) dowcide - a 0 . 10 ( 8 ) triethanolamine 85 % n . f 1 . 00 ( 9 ) chlorhexidine digluconate 20 % 0 . 16 ( 10 ) alpha tocopherol ( vitamin e usp ) 0 . 10 ( 11 ) stearic acid - triple pressed 3 . 00 ( 12 ) cetyl alcohol n . f . 1 . 50 ( 13 ) ethylene glycol monostearate 0 . 75 ( 14 ) dimethicone l - 45 - 350 cstks 2 . 00 ( 15 ) usp white wax 0 . 25 ( 16 ) paragon mepb 1 . 00 in formulating a 4 , 050 pound batch of the antimicrobial sanitizing and skin protective lotion of the invention , the following method steps were followed : ( a ) a surfactant phase is formulated by combining the following ingredients : 1 ) deionized water of reagent grade exhibiting less than 1 microohm resistivity is first added to a mixing tank in an amount of 405 . 40 gallons ( 3 , 382 . 59 lbs .) 2 ) versene 100 ( or a like equivalent edta sodium salt )( 6 . 06 lbs .) is added ; followed by 3 ) carbopol 934 p ( or a like equivalent acrylic polymer ) ( 14 . 18 lbs .) the mixer is engaged in the reverse mode while the circulating pump is turned on to full open , yielding a flow rate of about 110 - 150 gpm at a pressure of about 60 - 110 psi , for recirculation of the mixture . engagement of the pump in the reverse mode causes mixing to occur in a bottom to top direction within the tank . this reverse mode pumping coupled with the forceful agitation of the recirculating pump is critical in solubilizing the carbopol 934 in the mixture . homogenization of the above - mentioned ingredients is then carried out for about 30 - 40 minutes utilizing a stator - bladed motor driven homogenizer under flow conditions of about 110 - 150 gpm and at a pressure of about 60 - 110 psi , which conditions are sufficiently rigorous to yield a “ grain ” free and highly uniform product . 4 ) triton x - 100 surfactant ( or a like equivalent octyl phenyoxypolyethoxy non - ionic surfactant ) 121 . 5 lbs 6 ) tergitol np - 9 surfactant ( or a like equivalent nonylphenol polyethylene glycol ether non - ionic surfactant ) 81 . 00 lbs . 8 ) irgansan dp300 5 . 25 lbs . ( 2 , 4 , 4 ′- trichloro - 2 ′- hydroxydiphenyl ether ) 9 ) triethanolaxnine 85 % n . f . 40 . 50 lbs . 10 ) chlorhexidine digluconate 20 % 6 . 06 lbs . 11 ) alpha tocopherol 4 . 05 lbs . it is noted that the hydrophilic portion of the product is modified by the use of the non - ionic surfactant ( triton x - 100 ) in a propylene glycol base . the hydrophilic phase is further modified due to the inclusion of tergitol np - 9 which includes the nonoxyl class of compounds . inclusion of alpha tocopherol ( alpha tocopherol acetate ) commonly known as vitamin e has a two - fold benefit . its presence inhibits oxidation of the product as well as providing additional skin conditioning properties . since tocopherols are freely soluble in alcohols and lipids , they easily penetrate the skin layer and provide conditioning benefits . after all ingredients have been blended , the surfactant phase is then heated to within a range of about 70 ° c .- 85 ° c ., and maintained within this temperature range while mixing and pump recirculation are continued at about 110 - 150 gpm at a pressure of about 60 - 110 psi . ( b ) the wax phase is next formulated by adding the following ingredients : stearic acid - triple pressed 121 . 50 lbs . cetyl alcohol n . f . 60 . 75 lbs . ethylene glycol monostearate 30 . 38 lbs . dimethicone l - 45 - 350 cstks 81 . 00 lbs . white wax ( bareco be square ) 10 . 13 lbs . ; heating to within a range of about 70 ° c .- 85 ° c ., ideally about 77 ° c .- 80 ° c . ; and maintaining the temperature of the wax phase within this temperature range , while mixing at about 1500 - 1700 rpm using a direct drive mixer . the use of a wax , e . g . bareco be square , or a like equivalent which is a usp grade white wax having a melting point in the range of 70 ° c .- 85 ° c ., provides a unique property . the wax , which is in solution in coordination with the carbopol - 934 - p , melts through contact with the heat of the hands . this in turn forms a physical hydrophobic layer and provides a barrier which appears to inhibit penetration of liquids which are primarily hydrophilic in nature . this property helps protect the user from injury due to contact injurious materials , e . g . with acids and / or bases . the wax is apparently solubilized and dispersed with the aid of the surfactants and dimethicone within an alcohol / glycerol base . the presence of stearic acid , particularly triple pressed , is critical to effecting the complete solubilization of the remaining wax phase materials . while not wishing to be bound to any particular theory , it is believed that the wax flattens to form a neutral and hydrophobic barrier . the carbomers are believed to support the wax layer in the horizontal plane and in attachment to the skin . the carbomer molecule , which is believed to physically intercalate within the wax phase , thereby reinforcing the wax layer , is also believed to interact with the skin thereby having a stabilizing effect upon the wax layer , which results in the enhanced persistence characteristic of the product . lastly , it is believed that the processing steps orient the triclosan molecules to yield an optimum level of antimicrobial activity . ( c ) the final phase is formed by adding the wax phase to the surfactant phase . at the time of mixing , the wax phase is being maintained at approximately 85 ° c . and the surfactant phase is maintained at 80 ° c . the mixing takes place by using homogenization , recirculation and pressure . pressure generation is accomplished by restricting the outlet side of the pump , thus limiting the flow therethrough . this restriction keeps the pump stators full at all times , so as to avoid burn out of the pump . such conditions are maintained for 45 - 60 minutes using a 20 hp pump , at a rate of about 100 - 150 gal / min , at about 60 - 110 psi , in reverse mode , restricting the outlet and recirculating the batch . after approximately 60 minutes , the temperature is then lowered to less than 50 ° c . so that the paragon mepb parabens materials can be safely added . paragon mepb ( a mixture of methyl , ethyl , propyl , and butyl parabenzene in a phenoxy ethanol solvent , or a like equivalent mixture ) is then added ( 40 . 50 lbs .) and homogenization is continued for an additional 20 - 30 minutes with the recirculation pump on full open . in a particular embodiment , the mepb mixture had about 16 % methyl paraben , about 4 % ethyl paraben , about 2 % propyl paraben , about 6 % butyl paraben and the remainder , about 72 % of phenoxy - ethanol solvent . it is theorized that inclusion of dowcide - a , chlorhexidine gluconate and the parabens species in a phenoxy - ethanol solvent act as phenolic based preservatives to further increase hydrophobic solubility and thereby potentiate the active biocidal properties of the product . it is further theorized that the propylene glycol , cetyl alcohol , phenoxyethyl alcohol , parabens , and octyl phenol act as permeability barriers to the bacterial lipid cell wall ; that the triton - x 100 and triethanolamine offer an ionic approach to cell wall disruption via a chelation mechanism ; and that the phenoxyethyl alcohol , parabens and dowcide - a further provide cytoplasmic membrane permeation . it is to be understood that while a certain form of the invention is illustrated , it is not to be limited to the specific form or arrangement of parts herein described and shown . it will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and drawings .

US-78267601-A

a modular rotary cutter bed is formed by a series of essentially identical cutter modules mounted end - to - end along the length of a common support beam . guards for the cutters of the modules are arranged such that each guard overlaps and bridges the seam between an adjacent pair of modules so as to increase the structural rigidity of the cutter bed . each guard is attached at its front end to the noses of a pair of adjacent modules and at its rear end to the support beam to increase structural integrity in all directions . a second embodiment does not utilize a common support beam for the modules but instead relies upon the interconnections between adjacent modules and bridging overlap of the guards to rigidify the cutter bed .

the present invention is susceptible of embodiment in many different forms . while the drawings illustrate and the specification describes certain preferred embodiments of the invention , it is to be understood that such disclosure is by way of example only . there is no intent to limit the principles of the present invention to the particular disclosed embodiments . the rotary cutter bed 10 in fig1 is adapted to be attached to support structure ( not shown ) that renders cutter bed 10 suitable for use as part of a harvesting header , mower or other machine . see , for example , the header in u . s . pat . no . 6 , 158 , 201 , which patent is hereby incorporated by reference in its entirety into the present specification . in the embodiment of fig1 - 12 , a support frame or chassis of cutter bed 10 is defined in part by an elongated beam 12 that normally extends transversely of the path of travel of the mowing machine during use . as illustrated particularly in fig2 , 5 and 12 , beam 12 includes a generally reclined h - shaped member 14 having an upper , generally horizontally extending flange 16 , a lower generally horizontally extending flange 18 spaced below flange 16 , and a rearwardly projecting tail 20 that forms an extension of flange 18 . upper flange 16 is welded to lower flange 18 and tail 20 so as to form a secure weldment . a transversely square tubular member 22 is received within h - shaped member 14 and welded thereto to provide additional structural strength for beam 12 . a pair of brackets 24 and 26 adjacent opposite ends of bed 10 are fixed to beam 12 for use in securing beam 12 to structural parts of the mowing machine . generally speaking , as illustrated in fig1 a series of essentially identical cutter modules 28 are secured to beam 12 along the length thereof and project forwardly therefrom . in some embodiments ( not shown ), there may be relatively short “ dummy ” modules between adjacent cutter modules depending upon the type of internal drive mechanism used for the cutter bed , i . e ., short shafts may be housed within such dummy modules to interconnect the drives of adjacent cutter modules . each module 28 primarily includes a generally rectangular , flat , hollow housing or gear case 30 , internal drive mechanism 32 housed within gear case 30 , and an external rotary cutter 34 that is positioned outside of and on top of gear case 30 for rotation by drive mechanism 32 . it will be appreciated that each of these three major components may be modified in a variety of ways without departing from the principles of the present invention , e . g ., drive mechanism 32 may comprise a collection of drive shafts and intermeshing bevel gears instead of the spur gear arrangement illustrated in the preferred embodiment . each hollow gear case 30 is open at its opposite ends such that the chamber defined within the gear case communicates with the chambers of adjacent modules when the modules are secured in place along support beam 12 . in this way , the interior chambers of the modules can form a reservoir to contain an oil bath for the drive mechanism 32 . as illustrated in fig5 , a seal 36 may be clamped between each adjacent pair of the gear cases 30 to prevent oil leakage . each gear case 30 has a pair of opposite flat ends 38 . one end 38 has a pair of fastening bolts 40 projecting therefrom ( see in particular fig4 , 5 ), while the opposite end has a pair of through holes 42 for receiving bolts 40 of an adjacent module . nuts 43 at such opposite end of each gear case 30 may be tightened on bolts 40 to securely fasten adjacent gear cases 30 together . thus , when all of the modules 28 are butted up against one another along beam 12 and bolts 40 / nuts 43 are securely tightened in place , the abutting ends 38 of modules 28 present a series of fore - and - aft extending interfaces or seams 44 along the cutter bed . each gear case 30 may be provided with a pair of ribs 46 at opposite ends 38 thereof immediately adjacent seams 44 and extending in a fore - and - aft direction along the same to enlarge the surface area against which seals 36 may be compressed . each gear case 30 has a pair of rearwardly projecting mounting ears 48 at spaced apart locations along the rear edge thereof . as shown in fig5 , 10 and 12 ears 48 are adapted to be received between upper and lower flanges 16 , 18 of h - shaped member 14 . a pair of carriage bolts 50 pass vertically through flanges 16 , 18 and receiving holes 52 in ears 48 ( fig5 ) for securely fastening each module 30 to beam 12 . at the front of each gear case 30 , an arcuate , flange - like nose 54 projects forwardly from the rest of the gear case and is provided with a plurality of mounting holes 56 for use in attaching guards to modules 28 as hereinafter described in more detail . each gear case 30 also has a centrally disposed circular opening 58 in its top wall as illustrated in fig1 , providing access to the interior of the gear case . a circular cover plate 60 overlies each opening 58 and is secured in place by a plurality of removable screws 62 . as noted earlier , drive mechanism 32 may take a number of different forms . in the illustrated embodiment , mechanism 32 comprises three spur gears including a large central spur gear 64 ( fig1 ) and a pair of smaller spur gears 66 on opposite sides thereof ( see fig3 and 4 ). smaller spur gears 66 mesh with large spur gear 64 so as to transfer driving power to and away from large gear 64 . spur gears 66 project slightly beyond the flat ends 38 of each gear case 30 so that , when modules 28 are bolted in place along beam 12 , spur gears 66 of one module intermesh with spur gears of the next adjacent modules to form a complete gear train along the length of cutter bed 10 . in the illustrated embodiment , the eight rotary cutters 34 in the center of cutter bed 10 are intended to be driven in oppositely rotating pairs . thus , successive large gears 64 along cutter bed 10 have two smaller gears 66 between them to yield the proper direction of rotation . in the event that it is desired for adjacent cutters to rotate in the same direction , an odd number of smaller spur gears 64 would be provided in the gear train between each pair of larger gears 64 . in the illustrated embodiment in fig1 , it is preferable that the two most outboard rotary cutters 34 at each end of cutter bed 10 rotate inwardly in the same direction so as to convey crops cut by the two most outboard cutters toward the center of the machine ( as in the incorporated u . s . pat . no . 6 , 158 , 201 ). it is within the ambit of the present invention however , that all of the rotary cutters 34 in one half of cutter bed 10 could rotate in the same direction toward the center while all of the rotary cutters in the opposite half of the cutter bed 10 could rotate inwardly toward the center in the opposite direction . each large spur gear 64 has an integral , upright shaft 68 that defines the axis of rotation of the particular cutter 34 . as illustrated in fig1 , each shaft 68 projects upwardly through a bore 70 in the corresponding cover plate 60 and is journaled for rotation by a bushing or bearing set 72 . each rotary cutter 34 comprises a generally elliptical carrier plate 72 and a pair of free - swinging knives 74 at opposite ends thereof . each knife 74 is swingably attached to the carrier plate 72 by a pivot bolt 76 so that knife 74 swings out to a radially outwardly directed position during operation as a result of centrifugal force , but can yield if necessary when a hard object is encountered . as illustrated in fig1 , each carrier plate 72 is mounted on a hub 78 that is , in turn , secured to its corresponding shaft 68 by splines 80 on shaft 68 ( fig5 ), a washer 82 , and a nut 84 . a cap 86 overlies the top end of shaft 68 and nut 84 , while a series of screws 88 secure cap 86 and carrier plate 72 to hub 78 . the paths of travel of knives 74 of adjacent cutters 34 overlap one another along the line of centers defined by the row of shafts 68 , but adjacent cutters 34 are 90 ° out of phase with one another so that there is no risk of knives 74 of adjacent cutters striking each other . in the illustrated embodiment , each of the two endmost cutters 34 is provided with an upright , crop conveying cage 90 to help consolidate cut crop inwardly toward the middle of cutter bed 10 during operation . an intermediate conveying cage 92 is also utilized in the illustrated embodiment between the two cages 90 and is supported by overhead structure ( not shown ). all of the cages 90 , 92 rotate in a direction such that their front peripheries are disposed to move crop inwardly toward the middle of cutter bed 10 . modules 28 are provided with a number of guards 94 along the length of cutter bed 10 . details of construction of each guard 94 are illustrated particularly in fig6 - 12 . as shown in those figures , each guard 94 has a lower pan or skid 96 that is generally concave in a fore - and - aft direction to present a pair of laterally spaced , slightly upwardly and rearwardly upturned rear tabs 98 and 100 at its rear end and a generally upwardly facing flat margin 102 at its front end . pan 96 is constructed from sheet metal material and has four bolt holes 104 along the rear thereof in tabs 98 , 100 for the purpose of receiving fasteners 106 that attach the rear pan 96 to tail 20 of beam 12 . a notch 108 is defined between the two tabs 98 , 100 at the rear of each guard 94 . as illustrated in the figures , pan 96 is generally rectangular in overall configuration , although the two opposite side edges 110 and 112 converge slightly toward one another as the rear extremity is approached , following an initial front portion of each edge 110 , 112 that is parallel to the opposite edge . the front edge 114 of each pan 96 is scalloped so as to present a pair of forwardly convex sections 116 and 118 on opposite sides of a rearwardly indented central portion that defines a notch 120 . each guard 94 also includes a top lip 122 having a front edge 124 that is configured in the same manner as front edge of 114 of pan 96 . thus , front edge 124 of each lip 122 has a pair of convexly forwardly curved sections 126 and 128 on opposite sides of a rearwardly indented notch 130 . lip 122 is welded to pan 96 along the interface of lip 122 with the flat margin 102 of pan 96 such that lip 122 projects rearwardly from margin 102 to overhang and be spaced above downwardly inclined regions of pan 96 . front edge 124 of lip 122 and front edge 114 of pan 96 are disposed in vertical registration with one another to provide a front edge 132 on guard 94 that corresponds in shape to front edge 114 of pan 96 and front edge 124 of lip 122 , i . e ., front edge 132 of guard 94 has a pair of convexly forwardly arcuate segments 134 and 136 on opposite sides of a centrally disposed , rearwardly indented notch 138 . lip 122 has a rear edge 140 provided with a centrally disposed , straight transverse segment 142 and a pair of forwardly convexly arcuate segments 144 and 146 at opposite ends of straight segment 142 and which are concentric with corresponding front edge segments 134 and 136 . a total of four bolt holes 148 are provided along rear edge 140 for mounting purposes as hereinafter explained . further , opposite side edges 150 and 152 of lip 122 are provided with semi - circular notches 154 and 156 that overlie and are in vertical registration with corresponding semi - circular notches 158 and 160 in pan 96 . as will be seen , each superimposed pair of notches 154 , 158 and 156 , 160 serves to define one - half of an access hole when guard 94 is installed on cutter bed 10 . guards 94 are installed in such a manner that each of them spans or bridges a corresponding seam 44 between a pair of adjacent modules 28 . in other words , instead of each module 28 having its own guard 94 , each guard 94 is shared by a pair of adjacent modules 28 , i . e ., half of each guard 94 overlaps one module while the other half overlaps the next adjacent module . in this relationship , notch 138 of each guard 94 is disposed in fore - and - aft alignment with a corresponding seam 44 , while the opposite end edges 150 , 152 of each lip 122 are disposed in fore - and - aft alignment with corresponding upright shafts 68 of a pair of adjacent cutters 34 . thus , each lip edge 150 cooperates with the edge 152 of the adjacent guard lip to define a fore - and - aft extending joint 162 between the lips of adjacent guards that is in fore - and - aft alignment with the axis of rotation of the corresponding cutter 34 as defined by the shaft 68 . similarly , the semi - circular notches 154 , 158 on one guard 94 cooperate with the semi - circular notches 156 , 160 of the next adjacent guard 94 to define an access hole 164 for accessing the underside of pivot bolts 76 of knives 74 for installation and removal purposes . lip 122 of each guard 94 overlaps half of the nose 54 of one module 28 and half of the nose 54 of the next adjacent module 28 . bolts 166 pass through holes 148 in lip 122 and holes 56 in nose 54 to thereby secure the front of each guard 94 to the adjacent modules 28 . thus , each guard 94 is secured at its front to the modules 28 by bolts 166 and at its rear to the beam 12 by bolts 104 . while the rear ends of modules 28 are secured to beam 12 by carriage bolts 50 , guards 94 add further structural rigidity and support in a fore - and - aft sense to modules 28 . due to the overlapping relationship of guards 94 with seams 44 of the modules , guards 94 also provide increased structural rigidity and support to modules 28 along the length of cutter bed 10 . relative up and down movement between modules 28 is resisted by guards 94 . it will be noted that although the notches 138 of guards 94 are in alignment with seams 44 between modules 28 , the joints 162 between adjacent guards 94 are not in alignment with seams 44 or notches 138 . consequently , there is no opportunity for trash and dirt to wedge into areas immediately in front of seams 44 , as would be the case if joints 162 were in forward alignment with the seams . this helps reduce the tendency for premature wear and weakening of the cutter bed in the area of seams 44 and notches 138 . extraneous materials that may tend to collect in the vicinity of joints 162 appears to be readily handled by the knives in that area . fig1 illustrates a second embodiment of the invention wherein the cutter modules are not mounted on a common support beam and instead rely on their interconnections with one another for mutual structural support . the series of cutter modules is thus self - supporting in this respect . accordingly , the cutter module 228 and guard 294 of fig1 are identical to cutter module 28 and guard 94 of fig1 - 12 except in the way guard 294 is attached to the rear of module 228 . in this respect it will be appreciated that guard 294 is slightly shorter than guard 94 in a fore - and - aft direction and has an upturned , rear margin 294 a that bears against the rear faces of ears 248 of adjacent gear cases 230 . each guard 294 overlaps and bridges adjacent modules 228 in the same manner as guards 94 , and screws 294 b ( only one being shown ) secure rear margin 294 a to ears 248 of adjacent modules 228 so as to reinforce and structurally tie adjacent modules together . the front end of each guard 294 is secured to a pair of adjacent modules 228 in the same manner as in the first embodiment . the inventor ( s ) hereby state ( s ) his / their intent to rely on the doctrine of equivalents to determine and assess the reasonably fair scope of his / their invention as pertains to any apparatus not materially departing from but outside the literal scope of the invention as set out in the following claims .

US-96005607-A

an apparatus for cone beam computed tomography of an extremity has a digital radiation detector and a first device to move the detector along a circular detector path extending so that the detector moves both at least partially around a first extremity of the patient and between the first extremity and a second , adjacent extremity . the detector path has radius r 1 sufficient to position the extremity approximately centered in the detector path . there is a radiation source with a second device to move the source along a concentric circular source path having a radius r 2 greater than radius r 1 , radius r 2 sufficiently long to allow adequate radiation exposure of the first extremity for an image capture by the detector . a first circumferential gap in the source path allows the second extremity to be positioned in the first circumferential gap during image capture .

the following is a detailed description of the preferred embodiments of the invention , reference being made to the drawings in which the same reference numerals identify the same elements of structure in each of the several figures . in the context of the present disclosure , the term “ extremity ” has its meaning as conventionally understood in diagnostic imaging parlance , referring to knees , legs , ankles , fingers , hands , wrists , elbows , arms , and shoulders and any other anatomical extremity . the term “ subject ” is used to describe the extremity of the patient that is imaged , such as the “ subject leg ”, for example . the term “ paired extremity ” is used in general to refer to any anatomical extremity wherein normally two or more are present on the same patient . in the context of the present invention , the paired extremity is not imaged ; only the subject extremity is imaged . to describe the present invention in detail , the examples given herein for embodiments of the present invention focus on imaging of the load - bearing lower extremities of the human anatomy , such as the leg , the knee , the ankle , and the foot , for example . however , these examples are considered to be illustrative and non - limiting . in the context of the present disclosure , the term “ arc ” or , alternately , “ circular arc ”, has its conventional meaning as being a portion of a circle of less than 360 degrees or , considered alternately , of less than 2π radians for a given radius . embodiments of the present invention address the difficulties of lower extremity imaging by providing an imaging apparatus that defines orbital source and detector paths , concentric about a center point , wherein components that provide the source and detector paths are configured to allow patient access prior to and following imaging and configured to allow the patient to stand with normal posture during the cbct image capture series . in embodiments of the present invention , this capability is effected by using a detector transport device that has a circumferential access opening allowing positioning of the extremity , wherein the detector transport device is revolved about the positioned extremity once it is in place , enclosing the extremity as it is revolved through at least a portion of the scan . it is instructive to consider dimensional attributes of the human frame that can be considerations for design of cbct equipment for scanning extremities . for example , an adult human patient of average height in a comfortable standing position has left and right knees generally anywhere from about 10 to about 35 cm apart . for an adult of average height , exceeding about 35 - 40 cm ( 14 - 15 . 7 inches ) between the knees becomes increasing less comfortable and out of the range of normal standing posture . it is instructive to note that this constraint makes it impractical to use gantry solutions such as that shown in de 10146915 , described earlier , for knee imaging . either the source or the detector must be able to pass between the legs of a standing patient for knee cbct imaging , a capability not available with gantry or other conventional solutions . the perspective and top views of fig2 show how the scanning pattern is provided using various embodiments of a cbct imaging apparatus 10 according to the present invention . a detector path 28 of a suitable radius r 1 from a central axis a is provided by a first device , a detector transport 34 . a source path 26 of a second , larger radius r 2 is provided by a second device , a source transport 32 . the extremity , subject 20 , is substantially centered along central axis a so that central axis a can be considered as a line through points in subject 20 . the limiting geometry for image capture is due to the arc of source transport 32 , blocked by patient anatomy , such as by a paired limb , to typically about 200 degrees , as noted previously . this defines a partial circular sector , bounded by this arc and radii at start and end - of - scan . detector transport 34 , while capable of a fully circular orbit because it can be moved between the standing patient &# 39 ; s legs , follows the necessary complementary arc to that of source transport 32 . patient access before scanning is eased by providing a circumferential gap 38 in detector transport 34 . with detector transport 34 in the open position shown in fig3 , the patient can freely move in and out of position for imaging . when the patient is properly in position , detector transport 34 is revolved about axis a , substantially 180 degrees . this orbital movement confines the extremity more narrowly and places detector 24 , not visible in fig2 - 4 due to the detector transport 34 housing , in position near subject 20 for obtaining the first projection image in sequence . circumferential gap 38 not only allows access for positioning of the subject leg or other extremity , but also allows sufficient space for the patient to stand in normal posture during imaging , placing the subject leg for imaging in the central position of axis a ( fig2 ) and the non - imaged paired leg within the space defined by circumferential gap 38 . circumferential gap 38 extends approximately 180 degrees plus the fan angle , which is determined by source - detector geometry and distance . the top views of fig5 show the sequence for patient access for imaging apparatus 10 . in an open access position 40 , circumferential gap 38 permits access of the extremity so that it can be centered in position along central axis a . the outline of the foot corresponding to an open access position 42 indicates positioning of the patient and is shown for reference . in this example , the left leg is the subject imaged ; the paired right leg would lie within or just outside circumferential gap 38 . once the patient &# 39 ; s leg or other extremity is in place , detector transport 34 , or a hooded cover or other member that defines this transport path , can be revolved into position , closing the detector portion of circumferential gap 38 , as shown in a revolving transport position 44 . a transport in place position 46 shows detector transport 34 in suitable position for executing the cbct imaging sequence . the top views of fig6 continue the operational sequence begun in fig5 and show the sequence for obtaining cbct projections at a number of angular positions when using imaging apparatus 10 . the relative positions of radiation source 22 and detector 24 , which may be concealed under a hood , as noted earlier , are shown in fig6 . the source and detector are diametrically opposite at each position during the cbct scan and projection imaging . the sequence begins at a begin scan position 50 , with radiation source 22 and detector 24 at initial positions to obtain an image at a first angle . then , both radiation source 22 and detector 24 revolve about axis a as represented in interim scan positions 52 , 54 , 56 , and 58 . imaging terminates at an end scan position 60 . as this sequence shows , source 22 and detector 24 are in diametrically opposing positions relative to subject 20 at each imaging angle . throughout the scanning cycle , detector 24 is within a short distance d 1 of subject 20 . source 22 is positioned beyond a longer distance d 2 of subject 20 . the positioning of source and detector components can be carried out by separate actuators , one for each transport path , or by a single rotatable member , as described in more detail subsequently . it should be noted that scanning motion in the opposite direction , that is , clockwise with respect to the example shown in fig6 , is also possible , with the corresponding changes in initial and terminal scan positions . other features of imaging apparatus 10 are provided by the capability to move both source and detector transports 32 and 34 along the axis direction as a unit , as shown in the perspective view of fig7 . a vertical support 70 provides vertical transport of the imaging apparatus , so that the source and detector can be translated upwards or downwards in the direction of the central axis in order to suit patients of different heights and to image different portions of the leg . the height adjustment can be made before or after the patient &# 39 ; s subject leg to be imaged is enclosed by detector transport 34 using the setup sequence of fig5 . in one embodiment , vertical support 70 also allows rotation of the cbct imaging apparatus 10 to allow imaging of an extremity that is disposed horizontally or is extended at some oblique angle other than vertical . fig8 a and 8b show perspective views of knee imaging in a horizontal position , with the patient seated and the leg outwardly extended . full 360 degree rotation about an axis q is possible . it should be noted that , with this application , similar patient accessibility applies , with detector transport 34 revolved into position once the extremity is centered in place . further height adjustment is also possible , such as for arm , elbow , or shoulder imaging , as shown in fig9 . using revolving detector transport 34 simplifies patient access and provides sufficient imaging path for cbct imaging , since the angular limitation of the orbital imaging path is due to source obstruction , rather than to the detector path . thus , for example , detector transport 34 could fully encircle the limb , as shown in the examples of fig1 and 11 . in these embodiments , there is a circumferential gap 38 only in the source orbit . referring back to the schematic diagrams of fig6 , radiation source 22 and detector 24 each orbit the subject along an arc with radii r 2 and r 1 , respectively . within source transport 32 , a source actuator could be used , cooperating with a separate , complementary detector actuator that is part of detector transport 34 . thus , two independent actuator devices , one in each transport assembly , can be separately controlled and coordinated by an external logic controller to move source 22 and detector 24 along their respective arcs , in unison , about subject 20 . in an alternate embodiment , source and detector transport components are mechanically linked to a single revolving or rotating assembly . one such arrangement , shown at the right in fig1 a and enlarged in fig1 b , provides source and detector transports 32 and 34 using a single mechanical assembly , a rotating member 68 , on a turntable 64 that revolves about central axis of rotation a and provides the needed radii for source 22 and detector 24 . as is best shown in the top view of fig1 , detector 24 rides along the surface of the c - shaped turntable 64 , orbiting the subject at radius r 1 . source 22 is connected to turntable 64 along an arm 66 that provides the longer radius r 2 . circumferential gap 38 extends across both source and detector paths . it should be emphasized that the embodiments shown using rotating member 68 on turntable 64 can be encased in one or more housings , thereby providing similar appearance to imaging apparatus 10 shown in fig7 - 11 , for example . this type of arrangement has advantages for isolating the patient from moving components and for alleviating at least some of the patient anxiety that might be caused by automatically moving components during imaging . fig1 a shows sources and detector transports 32 and 34 and source and detector 22 and 24 components as they are fitted within covers 80 that protect moving mechanical parts and help to prevent patient contact with moving components . fig1 b shows the covered system with internal components in begin and end scan positions 50 and 60 respectively , when using the scan sequence described earlier with reference to fig6 . the top views of fig1 , 15 , and 16 show how patient access is provided using this mechanical arrangement . once the patient is positioned , rotating member 68 is swung around the positioned extremity , to a start position 72 , as shown at the bottom in fig1 . imaging begins at this position and continues as rotating member 68 revolves source and detector components about axis a . for the example of fig1 and 16 , rotating member 68 moves in a clockwise direction . counter - clockwise rotation would also be possible . rotating member 68 can also be used with an imaging configuration for upper extremities , as shown in fig1 . because none of the patient anatomy blocks the transport path , a full circular orbit is permitted for scanning with this configuration . again , full 360 degree rotation of the components in the plane of rotating member 68 is possible , about axis q . imaging of the ankle and foot is also possible with cbct imaging apparatus 10 . however , because the foot protrudes outward into the desired detector transport path , the allowable angular range for foot imaging is more constrained than the range for leg and knee imaging . the top view of fig1 shows , for example , that the angular range for cbct scanning of the foot , for a standing patient , is about 50 degrees less than that for knee imaging , for example . a range of optional devices can also be provided to facilitate the imaging process . for example , a horizontal or vertical foot support can be provided for support of the patient &# 39 ; s foot . optionally , the foot support can be adjustable to some oblique angle between horizontal and vertical , such as at a 33 degree or 45 degree angle for example . the invention has been described in detail with particular reference to a presently preferred embodiment , but it will be understood that variations and modifications can be effected within the spirit and scope of the invention . the presently disclosed embodiments are therefore considered in all respects to be illustrative and not restrictive . the scope of the invention is indicated by the appended claims , and all changes that come within the meaning and range of equivalents thereof are intended to be embraced therein .

US-201213681579-A

an abutment is provided with a screw access hole and a slot in its sidewall adapted to allow a driver to access a screw in the screw access hole at an angle relative to a longitudinal axis of the screw . the abutment may include a screw seat and may be connected to an implant via a screw in the screw seat . a prosthesis , which may include a driver access channel that has a diameter less than the outer diameter of the drive portion of the screw , may be placed over the abutment . methods of making a dental prosthesis and methods of attaching and removing the dental prosthesis from the implant are also disclosed .

although the invention will be described next in connection with certain embodiments , the invention is not limited to practice in any one specific type of dental assembly . the description of the embodiments of the invention is intended to cover all alternatives , modifications , and equivalent arrangements as may be included within the spirit and scope of the invention as defined by the appended claims . in particular , those skilled in the art will recognize that the components of the embodiments of the invention described herein could be arranged in multiple different ways . with reference now to the figs ., a dental assembly 10 is shown with an implant 12 , an abutment 14 , and a prosthesis 16 . in fig1 , prosthesis 16 is shown with driver access channel 18 at an angle θ off the longitudinal access of fixation screw 20 and implant 12 , as best shown in fig3 and 8b . a detailed view of the abutment 14 is shown in fig2 . in the embodiment shown , the abutment may include an optional anti - rotation feature 22 at the apical region 24 of abutment 14 that interfaces with engaging features of the implant at its coronal end ( not shown ) to position the abutment 14 radially . similarly , coronal region 26 of abutment 14 may include an optional anti - rotation feature 22 that interfaces with engaging features ( not shown ) of the prosthesis 16 . also , in the embodiment shown , the coronal region 26 of the abutment 14 may include grooves to improve securing , e . g . cementing , of the prosthesis 16 to the abutment 14 . slot 28 in the sidewall 29 of abutment 14 allows a driver to access the fixation screw 20 at an angle . such angular access allows for the placement of the driver access channel 18 on the lingual side of the prosthesis . abutment 14 also includes cavity 30 with a height 32 corresponding to the height 34 of the screw 20 . in this way , the screw 20 may move upwardly when being disengaged from the implant 12 while the prosthesis 16 remains attached to the abutment 14 . therefore , the screw 20 need not ever be completely removed through the prosthesis 16 , and the risk of inadvertent swallowing of the screw 20 during removal of the prosthesis 16 is decreased . stated differently , the screw 20 may disengage the implant 12 , but may also be contained within the cavity 30 of abutment 14 . referring still to fig2 , the abutment 14 may be dual colored . the abutment 14 has an apical portion 24 configured to be positioned within a gingival region of a patient &# 39 ; s mouth , and a coronal portion 26 configured to support the prosthesis 16 . the apical portion 24 may be a first color , generally gingival - colored , and the coronal portion 26 may a second color different from the first color , generally tooth - colored . such a dual - colored abutment allows for a more aesthetically pleasing installation . however , such dual coloring is optional . although the embodiments discussed herein are drawn toward single - unit dental assemblies , it is also possible to adapt the present invention to multi - unit bridge dental assemblies . in such an embodiment , the anti - rotational features 22 of the abutment 14 are not engaged by the implant 12 . however , the cavity 30 of the coronal portion 26 of the abutment 14 is configured similarly to the cavity 30 of the single - unit dental assemblies . as shown in fig3 and 4 , a conventional ball - point hex driver 36 may be used to drive fixation screw 20 through the abutment 14 and into the implant 12 . the driver 36 passes through driver access channel 18 , which may be sized such that driver 36 fits therethrough but screw 20 does not . through the use of a ball - point hex driver 36 , the user may change the angle θ of the driver 36 as driver 36 is rotated to insert or remove the screw 20 . alternatively , the user may hold the angle θ steady throughout the insertion and removal procedure . however , in applications where it is desirable to make the screw 20 removable , the radius 37 of driver access channel 18 may be widened to allow the screw 20 to pass fully therethrough . the dental assembly may be made through two main steps . first , conventional or digital processes may be used to design the dental assembly , which will be unique to each patient and application . then , the dental assembly may be manufactured either via conventional manufacturing techniques modified to include the driver access channel 18 or through computer - aided manufacturing techniques . turning now to fig5 - 6d , the prosthesis 16 may be formed by a modification to conventional methods . first , the dental professional makes an impression of the patient &# 39 ; s oral cavity using conventional transfer techniques . then , a stone model of the patient &# 39 ; s jaw bone is created , including an implant analog 38 replicating the exact implant 12 orientation and height . then the dental professional assembles abutment 14 onto implant analog 38 with screw 20 , ensuring that slot 28 in the sidewall 29 of abutment 14 is oriented at the desired position . a coping 40 is placed onto abutment 14 , again ensuring alignment of coping slot 42 in the sidewall 43 with abutment slot 28 . an access - channel plug 44 may be placed into slots 28 , 42 at the desired off - axis angle 8 . the access - channel plug 44 will represent the driver access channel 18 within the completed prosthesis 16 . acrylic wax may then be placed around the coping 40 and access channel plug 44 , and the plastic coping 40 may be modified as needed to create the desired prosthetic shape . standard laboratory processes may be used to fabricate the prosthesis from the wax inverse negative thus formed . as a result , the formed prosthesis will contain a driver access channel 18 of the same diameter as the shaft 46 of access - channel plug 44 , and screw 20 will be contained within abutment 14 in such a manner that it may not pass through the driver access channel 18 and is contained within the cavity 30 of abutment 14 . driver access channel 18 may thus have a generally elliptical shape with a long axis 45 and a short axis 47 , as best shown in fig1 . the long axis 45 is configured to allow the driver 36 to move along the driver access channel 18 to contact the screw continuously during rotation of the driver 36 . alternatively , prosthesis 16 may be formed using a digital workflow procedure . first , the dental professional conducts an intra - oral or impression scan using digital impression techniques . the data thus generated are imported into software that determines implant or abutment height as well as the required orientation of the engaging features . this or other software may then be used to determine the correct linear , axial , and rotational location of the dental assembly components , including the desired location and orientation of the side feature 28 of abutment 14 . software also designs the prosthesis with an appropriate off - axis drive access channel . finally , the prosthesis is fabricated following computer - aided manufacturing procedures . an exemplary computer - aided manufacturing process using a 3shape ® cad / cam system is provided for further illustration . first , data obtained from either an intra - oral or impression scan of the patient &# 39 ; s oral cavity are imported into the cad system . then , a computer model of the implant 12 and abutment 14 , the abutment 14 having a slot 28 in its sidewall 29 , is combined with a computer model of a prosthesis blank 49 in silico . the prosthesis blank 49 includes a scan adapter flat 51 that is aligned with the slot 28 in the sidewall 29 of the abutment 14 . see fig7 . the implant 12 , abutment 14 , and prosthesis blank 49 are placed within a visual depiction of the patient &# 39 ; s oral cavity in the appropriate location , with the scan adapter flat 51 aligned in the desired direction of the off - axis driver access channel 18 . the angle of this off - axis driver access channel 18 may be modified , as desired , in silico . the design software can then be used to transform the prosthesis blank 49 into an appropriate prosthesis 16 that includes the off - axis driver access channel 18 . once the design of the dental assembly 10 is complete , the actual prosthesis 16 may be formed from a milling process using the data obtained from the cad software . the milled prosthesis 16 may then be attached to an abutment 14 and implant 12 using cement , for example . it may be beneficial to insert an access channel plug 44 into the off - axis driver access channel 18 during the attachment of the prosthesis 16 to the abutment 14 to protect the screw 20 from the cement . indeed , the access channel plug 44 may be used to align the prosthesis 16 by inserting the access channel plug 44 into the head 50 of the screw 20 and then passing the prosthesis 16 over the access channel plug 44 and onto the abutment 14 . once the prosthesis 16 is formed and attached to the abutment 14 and implant 12 , the resulting dental assembly 10 may then be placed inside the patient &# 39 ; s oral cavity . turning now to fig8 a - 8d , dental assembly 10 may be assembled as follows . implant 12 may be installed in the patient &# 39 ; s jaw 48 using conventional procedures . pre - assembled abutment 14 and prosthesis 16 , which contains fixation screw 20 , may be aligned with implant 12 . driver 36 may be used to drive fixation screw 20 through abutment 14 and into implant 12 . conveniently , head 50 of screw 20 may rest in screw seat 52 of abutment 14 . screw seat 52 may be formed from titanium or some other similarly strong metal , thus reducing the risk of deformation or cracking during the screw tightening procedure . removal of the prosthesis may then be accomplished by the reverse of the installation procedure detailed above . while the present invention has been illustrated by the description of one or more embodiments thereof , and while the embodiments have been described in considerable detail , they are not intended to restrict or in any way limit the scope of the appended claims to such detail . the various features shown and described herein may be used alone or in any combination . additional advantages and modifications will readily appear to those skilled in the art . the invention in its broader aspects is therefore not limited to the specific details , representative apparatus and method and illustrative examples shown and described . accordingly , departures may be from such details without departing from the scope of the general inventive concept .

US-201615281550-A

a method of evaluating a chest wall protector comprises determining a flight time to impact on a subject of a projectile launched using a bow , determining an actuation time of a mechanism configured to release a string of the bow to launch the projectile based upon a desired time of receipt of energy from the projectile by a heart of the subject , determining an external location on an exterior surface of the subject corresponding to where a left ventricle of the heart of the subject is desirably close to the external surface , arranging at least one of the subject and the bow such that a flight path of the projectile is directed at the determined external location , disposing a protector device in the projectile &# 39 ; s flight path in contact with the subject , actuating the mechanism at the actuation time , and monitoring a heartbeat of the subject before and after transfer of energy from the projectile to the subject .

embodiments of the invention provide techniques for evaluating apparatus for guarding against commotio cordis . a test system is capable of precise control of speed , timing , and / or location of impact of a projectile upon a test subject . a bow is used to launch a rod with a projectile disposed on a leading end of the rod , with the projectile being or simulating an object of interest such as a sports ball , puck , etc . the bow is released using an electro - mechanical release device controlled by a controller that causes the bow &# 39 ; s release to induce impact of the projectile with the subject at a desired time during the subject &# 39 ; s heartbeat cycle . the projectile is test fired against the subject to determine timing of release and impact for each subject , and to determine proper sighting of the projectile . the subject is positioned relative to the bow such that the angle of impact of the projectile relative to the subject &# 39 ; s chest is about 90 °. other embodiments are within the scope of the invention . referring to fig1 , a commotio cordis testing system 10 includes a sling 12 , a launch mechanism 14 , an electrocardiographic recorder 16 , a stimulator 18 , an echocardiogram 20 , and an anesthesia supply apparatus 22 . the sling 12 is configured to hold a test subject 24 , here a pig with its legs 26 dangling from either end of the sling 12 . the system 10 is configured to control the angle , location , timing , and speed of impact of a projectile into the subject 24 held in the sling 12 , and to measure effects of the impact on the subject &# 39 ; s heartbeat . referring also to fig2 , the launch mechanism 14 includes a bow 30 ( not shown in fig1 ), a rod 32 , a projectile 34 , a platform 36 , a support frame 38 , and a release mechanism 40 . the bow 30 is preferably a standard compound hunting bow . it has been found that using a bow provides for better , more repeatable testing than other devices , e . g ., a pneumatic launcher , a baseball pitching machine ( using one or more rotating wheels ), etc . the bow 30 includes a frame 35 . the projectile 34 is the object of interest , for example , a baseball , lacrosse ball or hockey puck , or other object that may hit a person . the projectile 34 is attached to the rod 32 , such as an aluminum rod . the platform 36 supports and guides the rod 32 and the projectile 34 to hold the projectile 34 and the rod 32 before release of the bow 30 and to direct the projectile 34 to a desired portion of the subject 24 . the release mechanism 40 is preferably an electromechanical release under the control of the stimulator 18 that will release a string 31 of the bow 30 to launch the projectile 34 upon receiving a release command from the stimulator 18 . the release 40 is stationary such that the bow &# 39 ; s string 31 can be pulled to substantially the same location for each use and the force on the string 31 of the bow 30 due to the release mechanism 40 holding the string is repeatable . the release 40 can hold the string 31 with the bow 30 in a drawn position and release the string 31 in response to being actuated to impel the rod 32 and the projectile 34 toward the subject 24 . the force applied to the rod 32 and the projectile 34 is thus repeatable , and thus the speed at which the projectile 34 hits the subject 24 is repeatable . the speed may be adjusted by altering the amount that the string 31 is pulled and by adjustment of the draw weight of the bow 30 . the stimulator 18 is configured to process data , e . g ., by a processor executing stored software instructions , to perform operations as discussed below . the electrocardiogram is configured to monitor the heartbeat of the subject 24 and the stimulator 18 is configured to trigger the launcher 14 based upon the subject &# 39 ; s heartbeat and a desired timing of impact of the projectile 34 relative to the subject &# 39 ; s cardiac cycle . the electrocardiographic recorder 16 can monitor electric signals from the subject &# 39 ; s heart and provide r - wave data to the stimulator 18 . referring also to fig3 , a plot 50 shows that approximately 60 ms passes from a beginning qrs 52 of a beat , to a trough 54 . a peak 56 of the t - wave is approximately 300 to 350 ms after the onset of the qrs 52 . it has been found that a window 58 from about 30 ms to about 15 ms before the peak 56 of the t - wave is a period of particular vulnerability for chest impact inducing commotio cordis . the release 40 has a solenoid delay of about 5 ms from receipt of actuation signal to release of the bow &# 39 ; s string . the launch mechanism 14 is positioned relative to the subject 24 such that the flight time of the projectile 34 from release to impact is of a length such that if the release 40 is actuated at the beat beginning 52 , the projectile 34 will hit the subject 24 during the window 58 of the t - wave . the stimulator 18 marks each qrs 52 and puts out an electrical stimulus to the release 40 which causes release of the rod 32 . the time interval from the qrs 52 to the output electrical stimulus is adjustable in 1 ms time intervals . the flight time of the rod 32 and projectile 34 is between 150 and 400 ms , depending on the velocity . the flight time is determined by a test shot in which the projectile 34 is released toward a leg of the subject 24 . referring to fig4 - 5 , with further reference to fig1 - 2 , the subject 24 is arranged , and the launcher 14 is set up , such that the projectile 34 is directed at substantially the center of the heart 70 of the subject 24 . only the rod 32 and the projectile 34 of the launcher 14 are shown in fig4 - 5 for simplicity . the subject 24 and the launcher 14 are arranged such that the projectile 34 will be directed at about a 90 ° angle relative to the chest wall 72 of the subject 24 and hit the chest wall 72 where the distance from the chest wall 72 to the left ventricle is at or near its minimum . the echocardiogram 20 is used to probe the subject 24 to determine where the left ventricle is closest to the chest wall 72 . while this location varies from subject to subject , for a pig this location typically means that the angle of impact of the projectile 34 is at about a 15 ° upward angle relative to horizontal . thus , as shown , the launch mechanism 14 is set up to fire the projectile 34 horizontally and the subject is tilted approximately 15 ° away from the launcher 34 relative to a standing , upright position ( relative to the sagital plane 74 ). in fig5 , a chest wall protector 76 is inserted between the chest wall 72 and the sling 12 between the projectile 34 and the heart 70 . adjustments in the release time of the projectile 34 to account for the depth of the protector 76 may be made such that the force transferred to the subject 24 from the projectile 34 reaches the heart 70 at a desired time , e . g ., in the known critical window for inducing commotio cordis . using this setup , and by firing the projectile 34 such that the heart 70 receives the force of the projectile &# 39 ; s impact in the known critical time window , the ability and / or effectiveness of the heart / chest wall protector 76 in inhibiting commotio cordis may be evaluated . further , results using this setup , with the protector 76 , and with a setup without the protector 76 can be compared to evaluate the effectiveness of the protector 76 in inhibiting commotio cordis or other effects of the projectile &# 39 ; s impact . in operation , referring to fig6 , with further reference to fig1 - 5 , a process 100 for testing chest wall protectors using the system 10 includes the stages shown . the process 100 , however , is exemplary only and not limiting . the process 100 may be altered , e . g ., by having stages added , removed , or rearranged . at stage 102 , the location of the subject 24 where substantially the center of the heart 70 is closest to the chest wall 72 is determined . the user of the system 10 operates the echocardiogram 20 to take measurements , and evaluates the measured data to determine the point where the heart 70 is closest to the wall 72 . at stage 104 , the qrs and t - wave characteristics of the subject &# 39 ; s heart 70 are determined . the user operates the electrocardiographic recorder 16 to measure the time from onset of the qrs 52 to the peak 56 of the t - wave . the time to vulnerable period 58 is determined by taking the time in ms from the qrs 52 to the peak of the t - wave 56 and subtracting 15 to 30 ms . other characteristics may also be determined . at stage 106 , the flight time of the projectile 34 is determined . the subject 24 is positioned with a point of impact on the subject &# 39 ; s leg being at the same distance from the projectile 34 as the point of impact will be for impact at the subject &# 39 ; s heart 70 . the projectile is test fired / launched and the t - wave electrocardiogram monitored for disturbance . the flight time of the projectile 34 is determined by measurement on the electrocardiographic recorder 16 by determining the time from release to impact based on the monitored electrocardiogram disturbance . at stage 108 , the subject 24 and / or the launcher 14 is ( are ) positioned to provide for a desired impact of the projectile 34 against the subject 24 . the flight path and / or point of impact of the projectile 34 is determined by sighting down the launch mechanism 14 from a proximal portion ( e . g ., the release 32 ) toward the subject 24 . the subject 24 and launcher 14 are arranged with respect to each other such that the flight time will be substantially the same as for the test launch , and such that the projectile &# 39 ; s flight path is directed at the spot on the chest wall 72 closest to the left ventricle of the heart 70 and at an angle approximately perpendicular to the chest wall 72 at that point . for a pig , and with the rod 32 substantially horizontal before release , this orientation typically means tilting the subject 24 about 15 ° from a standing orientation of the subject 24 , exposing the underside of the subject 24 slightly to the launcher 14 . if a protector is being evaluated , the protector 76 is preferably placed in the flight path of the projectile 34 covering the location of the chest wall 72 closest to the left ventricle of the heart 70 . preferably , the protector 76 is disposed in direct contact with the subject 24 as shown , although the protector 76 could be disposed in indirect contact with the subject 24 , e . g ., externally to the sling 12 , with the sling 12 between the protector 76 and the subject 24 . at stage 110 , the launcher 14 is programmed and actuated , and results of projectile impact analyzed . the flight time is subtracted from the time to the vulnerable window 58 ( in msec ) and this is the time that the stimulator 18 triggers the release 40 . thus the time from qrs 52 to the impact is the addition of the time from qrs 52 to release and the flight time , allowing for the vulnerable time window 58 to be struck . the stimulator 18 detects the beginning 52 of a cycle , and actuates the release at the determined actuation time . the launcher 14 launches the projectile 34 , that hits the subject 24 and transfers energy to the subject 24 and the protector 76 . the electrocardiographic recorder 16 records the electrocardiogram measurement . the data is analyzed to determine whether commotio cordis was induced and to assess whether the impact occurred during the vulnerable window 58 . the process 100 may be repeated with the protector 76 , and with different protectors , and the effectiveness of the protector ( s ) evaluated . the process 100 is preferably repeated without using the protector 76 to determine the effect of the projectile &# 39 ; s impact on an unprotected subject . results of protected and unprotected impacts are analyzed / compared at stage 110 to determine the effectiveness of the protector 76 . in embodiments of the invention , the stimulator 18 can use information from a test firing of the projectile 34 to determine the flight time to the subject 24 . the stimulator 18 can use the flight time information and input data as to a desired time of impact relative to the t - wave cycle to determine an actuation time for the release 40 relative to the beginning 52 of a qrs cycle . the stimulator 18 can be configured to receive information about the t - wave from the electrocardiographic recorder 16 and determine the beat frequency by determining the average time between beginnings 52 of beats . the stimulator 18 can also be configured to determine the timing of the peak 56 of the t - wave relative to the t - wave cycle , and thus the window 58 of commotio cordis vulnerability ( from about 30 ms before the peak 56 to about 15 ms before the peak 56 ). other embodiments are within the scope and spirit of the appended claims . for example , due to the nature of software , functions described above can be implemented using software , hardware , firmware , hardwiring , or combinations of any of these . features implementing functions may also be physically located at various positions , including being distributed such that portions of functions are implemented at different physical locations .

US-19072305-A

a pesticidal composition comprising prallethrin and a neonicotinoid compound given in the following formula , or , as an active ingredient wherein , a represents a 6 - chloro - 3 - pyridyl , 2 - chloro - 5 - thiazolyl , tetrahydrofuran - 2 - yl , tetrahydrofuran - 3 - yl , 5 - methyltetrahydrofuran - 3 - yl , 3 - pyridyl , 6 - bromo - 3 - pyridyl , 3 - cyanophenyl , 2 - methyl - 5 - thiazolyl , 2 - phenyl - 5 - thiazolyl or 2 - bromo - 5 - thiazolyl group ; r 1 represents a hydrogen atom , methyl , ethyl , formyl or acetyl group ; r 2 represents a methyl , amino , methylamino , n , n - dimethylamino , ethylamino , n , n - diethylamino , n - methyl - n - ethylamino , 1 - pyrrolidinyl , methylamino or n - methyl - n - methylamino group ; r 3 represents a methyl , ethyl , propyl , propenyl or propynyl group ; x represents a nitrogen atom or ch group ; y represents a cyano , nitro or trifluoroacetyl group ; z represents a nh group or sulfur atom ; d represents an oxygen atom or — n — group ; m represents 0 or 1 ; and n represents 2 or 3 , has an excellently effective for controlling pests .

the examples of the neonicotinoid compounds of the formula ( 1 ) in the present composition include ( e )- n 1 -[( 6 - chloro - 3 - pyridyl ) methyl ]- n 2 - cyano - n 1 - methylacetamidine , n -[( 6 - chloro - 3 - pyridyl ) methyl ]- n - ethyl - n ′- methyl - 2 - nitro - 1 , 1 - ethylidenediamine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 3 - methyl - 2 - cyanoguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 1 , 3 - dimethyl - 2 - cyanoguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 1 - ethyl - 3 - methyl - 2 - cyanoguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 1 , 3 - dimethyl - 3 -( 6 - chloro - 3 - pyridyl ) methyl - 2 - cyanoguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 3 - methyl - 2 - nitroguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 3 , 3 - dimethyl - 2 - nitroguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 1 - methyl - 2 - nitroguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 1 , 3 - dimethyl - 2 - nitroguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 3 - ethyl - 2 - nitroguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 3 -( 6 - chloro - 3 - pyridyl ) methyl - 2 - nitroguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 3 - methyl - 2 - trifluoroacetylguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 1 - ethyl - 3 - methyl - 2 - nitroguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 1 , 3 , 3 - trimethyl - 2 - nitroguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 2 - nitroguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 1 - ethyl - 2 - nitroguanidine , 1 -( 3 - pyridyl ) methyl - 3 - methyl - 2 - nitroguanidine , 1 -( 6 - bromo - 3 - pyridyl ) methyl - 3 - methyl - 2 - nitroguanidine , 1 -( 2 - chloro - 5 - thiazolyl ) methyl - 3 - methyl - 2 - nitroguanidine , 1 -( 3 - cyanophenyl )- 3 - methyl - 2 - nitroguanidine , 1 -( 4 - chlorophenyl ) methyl - 3 - methyl - 2 - nitroguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 3 , 3 - dimethyl - 1 - formyl - 2 - nitroguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 3 , 3 - dimethyl - 1 - acetyl - 2 - nitroguanidine , 1 -( 6 - chloro - 3 - pyridyl )- 3 - methyl - 2 - cyanoguanidine , 1 -( 2 - chloro - 5 - thiazolyl ) methyl - 3 , 3 - dimethyl - 2 - nitroguanidine , 1 -( 2 - chloro - 5 - thiazolyl ) methyl - 1 - ethyl - 3 - methyl - 2 - nitroguanidine , 1 -( 2 - chloro - 5 - thiazolyl ) methyl - 1 - acetyl - 3 , 3 - dimethyl - 2 - nitroguanidine , 1 -( 6 - chloro - 3 - pyridyl ) methyl - 1 - methyl - 2 - trifluoroacetylguanidine , 1 -( 2 - chloro - 5 - thiazolyl ) methyl - 1 , 3 - dimethyl - 2 - nitroguanidine , 1 -( 2 - chloro - 5 - thiazolyl ) methyl - 1 - methyl - 2 - nitroguanidine , 1 -( 5 - thiazolyl ) methyl - 3 - methyl - 2 - nitroguanidine , 1 -( 2 - methyl - 5 - thiazolyl ) methyl - 3 , 3 - dimethyl - 2 - nitroguanidine , 1 -( 2 - methyl - 5 - thiazolyl ) methyl - 3 - methyl - 2 - nitroguanidine , 1 -( 2 - phenyl - 5 - thiazolyl ) methyl - 3 - methyl - 2 - nitroguanidine , 1 -( 2 - chloro - 5 - thiazolyl ) methyl - 3 , 3 - diethyl - 2 - nitroguanidine , 1 -( 2 - chloro - 5 - thiazolyl ) methyl - 3 - methyl - 3 - ethyl - 2 - nitroguanidine , 1 -( 2 - chloro - 5 - thiazolyl ) methyl - 3 -( 1 - pyrrolidinyl )- 2 - nitroguanidine , 1 -( 2 - chloro - 5 - thiazolyl ) methyl - 1 , 3 , 3 - trimethyl - 2 - nitroguanidine , 1 -( 2 - bromo - 5 - thiazolyl ) methyl - 3 - methyl - 2 - nitroguanidine , 1 -( 2 - bromo - 5 - thiazolyl ) methyl - 3 , 3 - dimethyl - 2 - nitroguanidine , 1 -( 2 - chloro - 5 - thiazolyl ) methyl - 3 - methyl - 2 - cyanoguanidine , 1 -( tetrahydrofuran - 3 - yl ) methyl - 3 - methyl - 2 - nitroguanidine and 1 -( tetrahydrofuran - 2 - yl ) methyl - 3 - methyl - 2 - nitroguanidine . the examples of the neonicotinoid compounds of the formula ( 2 ) in the present composition include 1 -[( 6 - chloro - 3 - pyridyl ) methyl ]- n - nitro - 2 - imidazolidineimine , 3 -[( 6 - chloro - 3 - pyridyl ) methyl ]- n - cyano - 2 - thiazolidineimine and 1 -[( 6 - chloro - 3 - pyridyl ) methyl ]- n - nitrotetrahydropyrimidine - 2 - imine . the examples of the neonicotinoid compounds of the formula ( 3 ) in the present composition include 3 -[( 2 - chloro - 5 - thiazolyl ) methyl ]- 5 - methyl - 4 - nitroiminotetrahydro - 1 , 3 , 5 - oxadiazine , 3 , 5 - dimethyl - 1 -[( 6 - chloro - 3 - pyridyl ) methyl ]- 2 - nitroiminohexahydro - 1 , 3 , 5 - triazine , 3 , 5 - dimethyl - 1 -[( 2 - chloro - 5 - thiazolyl ) methyl ]- 2 - nitroiminohexahydro - 1 , 3 , 5 - triazine , 3 - ethyl - 5 - methyl - 1 -[( 6 - chloro - 3 - pyridyl ) methyl ]- 2 - nitroiminohexahydro - 1 , 3 , 5 - triazine , 3 - n - propyl - 5 - methyl - 1 -[( 6 - chloro - 3 - pyridyl ) methyl ]- 2 - nitroimino hexahydro - 1 , 3 , 5 - triazine , 3 - n - propyl - 5 - methyl - 1 -[( 2 - chloro - 5 - thiazolyl ) methyl ]- 2 - nitroiminohexahydro - 1 , 3 , 5 - triazine , 3 -( 2 - propenyl )- 5 - methyl - 1 -[( 6 - chloro - 3 - pyridyl ) methyl ]- 2 - nitroiminohexahydro - 1 , 3 , 5 - triazine and 3 -( 2 - propynyl )- 5 - methyl - 1 -[( 6 - chloro - 3 - pyridyl ) methyl ]- 2 - nitroiminohexahydro - 1 , 3 , 5 - triazine . the targeted pests controlled by the present composition are , for example , the following arthropods : pillbugs and isopoda ( sowbugs ) such as oniscus asellus , armadillidium vulgare ( latreille pillbug ) and porcellio scarber ; diplopoda such as blanilus guttulatus ( millepede ); chilopoda such as geophilus carpophagus , scutigera spp ., scolopendra subspini and thereunema spp . ; symphyla such as scutigerella immaculata ; thysanura ( bristletails ) such as ctenolepisma villosa ( oriental silverfish ) and lepisma saccharina ( silverfish ); psocoptera such as trogium pulsatorium ( larger pale booklice ); collembola ( snowfleas ) such as onichiurus armatus ; isoptera ( termites ) such as mastotermitidae , termopsidae ( e . g . zootermopsis , archotermopsis , hodoterrnopsis , porotemes ), kalotermitidae ( e . g . kalotermes , neotermes , cryptotermes , incisitermes , glyptoterrmes ), hodoterrnitidae ( e . g . hodotermes , microhodotermes , anacanthotermes ), rhinotermitidae ( e . g . reticulitermes , heteroterrnes , coptotermes , schedolinotermes ), serriterrnritidae and termitidae ( e . g . amitermes , drepanotermes , hopitaliterrmes , trinervitermes , macrotermes , odontotermes , microtermes , nasutitermes , pericapritermes , anoplotermes ); dictyoptera ( cockroaches ) such as blatta orientalis ( oriental cockroach ), periplaneta americana ( american cockroach ), periplaneta fuliginosa ( smokybrown cockroach ), leucophaea maderae and blattella germanica ( german cockroach ); orthoptera such as gryllotapa spp . ( mole cricket ), acheta domesticus , teleogryllus emma ( field cricket ), locusta migratoria ( asiatic locust / oriental migratory locust ), melanoplus differentialis and schistocera gregaria ; dermaptera ( earwigs ) such as labidura riparia and forficula auricularia ; anoplura such as phthirus pubis , pediculus humanus , haematopinus sulus , linognathus spp . and solenopotes spp . ; mallophaga such as trichodectes spp ., tromenopon spp ., bovicola spp . and felicola spp . ; thysanoptera ( thrips ) such as frankiniella intonsa ( flower thrips ), onion thrips , thrips tabaci ( cotton seedling thrips ) and thripspalmi ; heteroptera such as nezara spp ., eurygaster spp ., dysdercus intermedius , cimex lectularis , triatoma spp ., rhodnius prolixus , nezara antennata ( green stink bug ) and cletus puncttiger ; homoptera such as aleurocanthus spiniferus ( citrus spiny whitefly ), bemisia tabaci ( sweetpotato whitefly ), trialeurodes vaporariorum ( greenhouse whitefly ), cotton asphid , aphis gossypii ( melon aphid ), brtevicoryne brassicae ( cabbage asphid ), cryptomyzus ribis , aphis fabae , macrosiphum euphorbiae ( potato aphid ), myzus persicae ( green peach aphid ), phorodon humuli , empoasca spp ., nephootettix cincticeps ( green rice leafhopper ), lecanium corni ( brown scale ), saissetia oleae ( black scale ), laodelphax striatellus ( small brown plant hopper ), nilaparvata lugens ( brown rice planthopper ), aonidiella aurantii ( red scale ), aspidiotus hederae ( ivy scale ), pseudococcus spp ., psylla spp . and phylloxera vastrix ; lepidoptera such as pectinophora gossypiella ( pink bollworm ), lithocolletis blancardella , plutella xyloste ( diamondback moth ), malacosoma neustria ( tent catapillar ), euproctis subflava ( oriental tussock moth ), lymantria dispar ( gypsy moth ), bucculatrixpyrivorella ( pear leafniner ), phyllocnistis citrella ( citrus leatniner ), agrotis spp ., euxoa spp ., earias insulana , heliothis spp ., spodoptera exigua ( beet armyworm ), spodoptera litura ( common cutworm ), spodoptera spp ., mamestra brassicae ( cabbage armyworm ), trichoplusia ni , carpocapsa pomonella , pieris spp ., chilo spp ., pyrausta nubilalis , ephestia kuehniella ( mediterranean flour moth ), galleria mellonella ( greater wax moth ), tineola bisselliella ( webbing clothes moth ), tenea translucens , oriental tea tortrix ( homona magnanima ) and totrix viridana ; coleoptera ( beetles ) such as anobium punctatum , rhizopertha dominica ( lesser grain borer ), acanthoscelides obectus ( bean weevil ), agelastica alni , leptinotarsa decemlineata , phaedon cochleariae , diabrotica spp ., psylliodes angusticollis ( solanum flea beetle ), phyllotreta striolata ( striped flea beetle ), epilachna spp ., atomaria spp ., oryzaephilus surinamensis ( sawtoothed grain beetle ), anthonomus spp ., sitophilus spp ., otriorhynchus sulcatus ( black vine weevil ), cosmopolites sordidus ( banana weevil borer ), ceuthorhyncidius albosuturalis , hypera postica ( alfalfa weevil ), dermestes spp ., trogoderma spp ., attagenus unicolor ( black carpet beetle ), lyctus spp ., meligethes aeneus , ptinus spp ., gibbium psylloides , tribolium spp ., tenebrio molitor ( yellow mealworm ), agriotes spp ., melolontha mololontha , scolytidae ( e . g . xyleborus and scolytoplatypus ), cerambycidae ( e . g . monochamus , hylotrupes , hesperophanus , chlorophorus , palaeocallidium , semanotus , purpuricenus , stromatium ), platypodidae ( e . g . crossotarsus , platypus ), bostrychidae ( e . g . dinoderus , bostrychus , sinoderus ), anobiidae ( e . g . ernobius , anobium , xyletinus , xestobium , ptilinus , nicobium , ptilineurus ) and buprestidae ; hymenoptera such as diprion spp ., hoplocampa spp ., lasius spp ., formica japonica , vespa spp ., and siricidae ( e . g . urocerus , sirex ); diptera such as aedes spp ., anopheles spp ., culex spp ., drosophila melanogaster , musca domestica ( housefly ), fannia spp ., calliphora spp ., lucilia spp ., chrysomya spp ., cuterebra spp ., gastrophilus spp ., stomoxys spp ., oestrus spp ., hypoderma spp ., tabanus spp ., bibio hortulanus , pegomyia hyoscyami , ceratitus capitata , dacus dorsalis ( oriental fruit fly ), tipula paludosa , simulium spp ., eusimulium spp ., phlebotomus spp ., culicoides spp ., chrysops spp ., haematopota spp ., braula spp ., morellia spp ., glossina spp ., wohlfahrtia spp ., sarcophaga spp ., lipoptena spp ., melophagus spp . and muscina spp . ; siphonaptera such as xenopsylla cheopis , ceratophyllus spp ., pulex spp . ( human flea ) and ctenocephalides spp . ( cat flea / dog flea ); arachnida such as scorpio maurus , latrodectus mactans and chiracanthium spp . ; mites such as otodectus spp ., acarus siro ( grain mite ), argas spp ., ornithodoros spp ., ornithonyssus spp ., dermanyssus spp ., eriophyes spp ., chelacaropsis moorei , dermatophagoides spp ., psoroptes equi , chorioptes spp ., saracoptes spp ., tarsonemus spp ., clover mite ( bryobia praetiosa ), panonychus spp ., tetranychus spp . ( spider mites ), raillietas spp ., pneumonyssus spp ., sternostorma spp ., acarapis spp ., cheyletiella spp ., myobia spp ., psorergates spp ., demodex spp ., trombicula spp ., listrophorus spp ., tyrophagus spp ., sarcoptes spp ., notoedres spp ., cytodides spp ., laminosioptes spp . ; and the like . for the present invention , the mixing ratio of prallethrin and the neonicotinoid compounds is the ratio wherein prallethrin and the neonicotinoid compounds show a synergistic effect , and usually from 100 : 1 to 1 : 100 parts by weight , preferable within the range from 10 : 1 to 1 : 10 . the present composition may be prepared only from prallethrin and the neonictinoid compounds , but for practical uses , the present composition is utilized usually as a formulation that appropriately contains an inert carrier . therefore , the present composition usually comprises solid carriers , liquid carriers , auxiliaries or the like as well as prallethrin and the neonictinoid compounds . suitable forms of formulation include liquid formulations such as emulsifiable concentrates , oil formulation and suspensible concentrates , dust , wettable powder , granules , paste formulation , microencapsulated formulation , foaming formulation , aerosol , liquid carbon dioxide solution and sheet formulation . the amount of prallethrin and neonicotinoid compounds incorporated depends on the formulation form , but the total content of prallethrin and neonicotinoid compounds is usually from 0 . 005 to 50 % by weight . the above - mentioned formulations may be obtained by standard methods , for example , mixing prallethrin and neonicotinoid compounds with solid or liquid carrier ( s ), and optionally , adding auxiliaries such as emulsifiers or adhesives . as the carrier that is used in the situation of formulating , the following are suitable . suitable solid carriers include , for example , natural - occurring or synthetic minerals such as clay , kaolin , talc , bentonite , sericite , quartz , sulfur , active carbon , calcium carbonate , diatomaceous earth , pumice , calcite , sepiolite , dolomite , silica , alumina , vermiculite and perlite , as well as powdered forms of sawdust , an ear of corn , palm tree coconut shells and tobacco stems . suitable liquid carriers include , for example , aromatic or aliphatic hydrocarbons such as xylene , toluene , alkylnaphthalene , phenylxylylethane , kerosene , gas oil , hexane and cyclohexane ; halogenated hydrocarbons such as chlorobenzene , dichloromethane , dichloroethane and trichloroethane ; alcohols such as methanol , ethanol , isopropyl alcohol , butanol and hexanol ; ethers such as diethyl ether , tetrahydrofuran and dioxane ; esters such as ethyl acetate and butyl acetate ; ketones such as acetone , methyl ethyl ketone , methyl isobutyl ketone and cyclohexanone ; nitriles such as acetonitrile and isobutyronitrile ; dimethylsulfoxide ; amides such as n , n - dimethylformamide and n , n - dimethylacetamide ; botanical oils such as soybean oil and cottonseed oil ; water ; and so on . suitable auxiliaries for formulation include , for example , nonionic emulsifiers such as polyoxyethylene fatty acid esters and polyoxyethylene fatty acid alcohol ethers ; ionic emulsifiers such as alkylsulfonic acid salts , alkylsulfuric acid salts and arylsulfonic acid salts ; dispersing agents such as ligninsulfonic acid salts and methylcellulose ; adhesives such as carboxymethyl cellulose , gum arabic , polyvinyl alcohol and polyvinyl acetate ; and coloring agents such as iron oxide , titanium oxide , persian blue , alizarine dye , azo dye and phthalocyanine dye . moreover , the present composition may comprise active ingredients other than pralethrin and the neonicotinoid , or synergists such as piperonyl butoxide ( pbo ), octachlorodipropyl ether ( s421 ), n -( 2 - ethylhexyl ) bicyclo [ 2 . 2 . 1 ] hept - 5 - ene - 2 , 3 - dicarboximide , isobornyl thiocyanatoacetate ( ibta ) and n -( 2 - ethylhexyl )- 1 - isopropyl - 4 - methylbicyclo [ 2 . 2 . 2 ] oct - 5 - ene - 2 , 3 - dicarboximide . the present composition may be employed usually on the soil or in places wherein harmful arthropods inhabit , but may cooperate in the production of products that controls pests by administering into a synthetic resin sheet or sheathed electric lines . the employed amount is about from 0 . 001 to 10 mg / m 3 of the active ingredients ( the total of prallethrin and the neonicotinoid compounds ) when the present composition is utilized in a situation of household use , and for example , in the situation of controlling mosquitoes and flies indoors . furthermore , when controlling ants or cockroaches , the active ingredients are employed at about from 0 . 001 to 100 mg / m 3 . in the case of controlling timber pests such as termites and powderpost beetles , the present invention may be employed directly onto the said pest , but said composition is usually employed on the inhabiting timber or soil of the pest . the employed amount differs upon the sort of objective harmful arthropods , formulation , employed area or employed method , but generally the amount of the active ingredients ( prallethrin and neonicotinoid compounds ) is about form 0 . 1 to 10 , 000 mg / m 2 . in addition , in the case the present composition is utilized for agricultural purposes , an amount from 0 . 1 to 1 , 000 g / ha of the active ingredients is employed onto the soil , plants , or directly onto the harmful arthropods . in that situation , the present composition is employed as emulsifiable concentrates , suspensible concentrates or wettable powders by dissolving in water usually at about from 1 to 1000 ppm . one part by weight of tokuseal gu - n ( tokuyama corp . product ) and 5 parts by weight of ( e )- n 1 -[( 6 - chloro - 3 - pyridyl ) methyl ] acetamidine were mixed and pulverized in an centrifugal pulverizer ( the powder ). separately , 1 part by weight of prallethrin was dissolved in 9 parts by weight of solvesso 150 ( exxon product ) and absorbed into 7 parts by weight of tokuseal gu - n ( the oil absorption ). after mixing the oil absorption and the powder , 4 parts by weight of sorpol 5060 ( toho chemical product ), 2 parts by weight of demol snb ( kao corp . product ) and 71 parts by weight of fubasami clay a300 ( fubasami clay product ) were added , and mixed in a mixer to obtain 100 pasts by weight of wettable powder . one half ( 0 . 5 ) μl of the following acetone dissolving solution wherein the concentration was adjusted to set forth a dosage given below , was applied to the back thoracic region of a housefly ( musca domestica ) which is resistant to pyrethroid and the mortality was examined 2 days later . the average of the results after repeating the example thrice are given in table 1 and table 2 . three ( 3 ) cm of soil was packed into the central inner portion of a glass tube that has an inner diameter of 1 . 7 cm and is 15 cm long , and on one surface of the soil , 0 . 7 ml of each aqueous solution that has the examined compound formulated to a determined dilution ( examined compound and applied concentration given in table 3 ). subsequently , 4 % agar was inserted onto both surfaces of the soil , 50 worker formosan subterranean termites ( coptotermes formosanus ) and 5 soldier formosan subterranean termites were deposited into side of the inner part of the tube wherein no compound was applied , and the tunneled soil condition by the termites was examined a week later . the example was repeated thrice . the results are given in table 3 . within the results of table 3 , a represents a condition wherein the termites tunneled through the surface of the soil of the treated side and the non - treated side , b represents a condition wherein the surface of the soil of the treated side was tunneled through and the agar was tunneled halfway , c represents a condition wherein the surface of the soil of the treated side was incompletely tunneled through and the agar had no visible tunneling .

US-63770200-A

a system and method for an intelligent hair drying / styling apparatus with user information transmission and storage capabilities is herein provided . the hair drying / styling apparatus houses a control circuit board and an infrared or temperature sensor in order detect an individual &# 39 ; s hair condition moisture level to determine a user specific , customizable dryer setting . the information detected by the sensor is stored locally , on a proximal internet - enabled device , or on a remote or cloud - based server and accessed by the hair drying / styling apparatus through a wireless local area network connectivity function . accordingly , a user &# 39 ; s hair temperature - drying profile may be stored and later recalled to provide optimal hair styling setting customized for that user . this innovation will enable any number of hair professionals and or end consumers to improve styling and dry time . such a profile may contain a proprietary v - factor calculation that will , among other applications , correspond to the use of a coordinated and optimized hair spray solution . according to the present invention , energy usage is reduced to enable a more efficient design .

fig1 is a schematic diagram overview of the overall key internal components within the drying device . in accordance with the preferred embodiment of the present invention , the drying device 100 utilizes vents 102 that allow for efficient airflow through the device . the drying device 100 utilizes a heating system that is made up of a fan 108 and a connected motor 104 that are housed within a motor shroud 106 . a ceramic holder 110 connects the fan 108 and motor 104 to the heater 118 . heat is generated within the heater 118 by an internal quartz infrared bulb 112 that is held in place by the ceramic holder 110 . air is drawn through the motor powered 104 fan intake 108 , and directed into the heater 114 , heated up using the quartz infrared bulb 112 and through the exhaust by way of the connected concentrator 116 at the heating tip of the dryer . fig2 is a block diagram overview of several functionality components of the drying / styling device . in accordance with the preferred embodiment of the present invention , the drying / styling device is comprised of several components which make up the core control algorithm 200 that manages the key features of the device . the controlling output manages heat and airflow in response to explicit user controls 202 . the controlling output responds to data gathered by the sensor readings 204 . these collected sensor readings 204 are used for analysis and user feedback / education based on the specific user profile type , communicating with system actuators 206 . the algorithm 200 interprets the user 212 profile information from data gathered from local user equipment through wireless communication 208 . profile information is interpreted using a remote server 214 over a wireless network connection . fig3 is an overview of the user control settings shown displayed to the user of the drying / styling device . in accordance with the preferred embodiment of the present invention , the user controls are the traditional components used to operate a hair dryer . these components include a component such as a button , knob , switch , or dial to control airflow 312 speed and heat 300 . these controls serve as an override to the automatic determination algorithm . for instance , if a user specifies high heat 308 and low airflow 316 , the output should be adjusted to reflect the setting , regardless of the sensor &# 39 ; s readings except for safety limitations . the following user heat 300 controls could be provided : off 302 ; low 304 ; medium 306 ; high 308 ; and auto 310 . the following user airflow 312 controls could be provided : off 314 ; low 316 ; medium 318 ; high 320 ; and auto 322 . alternatives include a subset of these fields ( e . g ., possibly eliminating the “ medium ” option ), or a continuous sliding option from 0 to 100 % capacity . fig4 is a block diagram that provides a high - level overview of the main components of the drying / styling device . in accordance with the preferred embodiment of the present invention , the main software components of the drying / styling device consist of the following : the “ dryer ” module 400 , which sits on an idle loop waiting for commands to be placed into the queue 402 and performs the appropriate action once a command has been received ; the “ queue ” module 402 , which functions as the central message broker that manages requests for work units to be performed ; the “ timer ” module 404 , which posts commands to the queue that direct the dryer module to perform certain actions at periodic intervals ; the “ wireless ” module 406 that is responsible for transmitting and receiving data ; the “ sensors ” module 408 , which communicates and transmits internal data from the drying / styling device &# 39 ; s various sensing mechanisms ; the “ actuators ” module 412 , that controls heating and voltage through an algorithm based on the conditions detected by the sensors 408 ; the “ nvram ” module 414 , nonvolatile memory that stores user preferences so that they can be preserved across power cycles as well as session and log data ; and the “ logging ” module 410 that handles all request for status information to be sent to a remote interface for human or machine analysis . the logging module 410 utilizes four ( 4 ) interfaces for data entry and transmission . the log data can be stored on the drying / styling device through usb or micro sd card outputs , allowing for the dryer to write log information directly to the disk and perform a debug interface for analysis . data can also be stored on an emulation platform , accessed through a filesystem , allows for off - target debugging and off - target log entry storage in identical format to that of an on - device micro sd card . data can be stored on a cloud based server , accessed through a protocol such as http post websocket to allow the dryer to send diagnostic information to a remote server . data can also be sent to a mobile device using a communication mechanism such as bluetooth or http post websocket , whereby the drying / styling device can send diagnostic information to a mobile device such as a smartphone , tablet or laptop that is located within rough proximity to the drying / styling device . fig5 is a block diagram that defines sensor data types recognized by the drying / styling device . in accordance with the preferred embodiment of the present invention , the sensor functionality 500 within the drying / styling device recognizes the following data modules . the first data type is the u16 sensor 502 that outputs an unsigned 16 - bit word , whereby the data from this sensor is timestamped 504 at the time of when the value 506 was read from the sensor and the value is the unsigned word read from the sensor . the second data type is the u16 3d sensor 508 , that outputs three ( 3 ) unsigned 16 - bit words whereby there are four ( 4 ) fields of output data that comprise of the timestamp 510 from when the command was sent , the value read from the sensor in the x - dimension 512 , the value read from the sensor in the y - dimension 514 , and the value read from the sensor in the z - dimension 516 . the third data type is the tri - state sensor 518 whereby output regarding the status of the tri - state is generated to include the timestamp 520 and the value 522 read from the sensor . the last sensor type is the button sensor 524 whereby output is generated regarding button information , that is comprised of a timestamp 526 and value read 528 from the button sensor . fig6 is a block diagram of interrupt hardware mapping data within the internal processing queue of the drying / styling device . in accordance with the preferred embodiment of the present invention , the internal processing module of the drying / styling device places sensing data in a queue to be processed in a time - sensitive manner . some sensor material 610 may meet or exceed the predetermined threshold as programmed by the queue , such as an expired timer 600 or buffered packets that are ready to be processed from an external memory source . in each of these cases , it is desirable to service the time sensitive material as quickly as possible and defer the processing of that data to a less time - critical context . the block diagram shows how interrupt mappings are defined . on platforms where the number of hardware lines may be limited , these interrupts may be multiplexed onto a reduced number of interrupt lines , with the original source information made available as part of the payload data . handlers for these interrupts are designed to execute in as little time as possible . as a result , most post commands onto the queue and return as opposed to servicing the request directly . interrupt code “ irq_0 ” 602 is designated for the timer module 600 . the wireless module 604 has two ( 2 ) interrupt codes : “ irq_1 ” 606 and “ irq_2 ” 608 , whereby “ irq_1 ” 606 is designated for wireless 604 transmissions whereas “ irq_2 ” 608 is designated for wireless 604 receiving . the remaining interrupts are designated for the sensor module 610 . “ irq_3 ” 612 is designated to transmit data for nearby temperature . “ irq_4 ” 614 is designated to transmit data relating to the humidity levels detected . “ irq_5 ” 616 is designated to transmit detected temperature data that is further away . “ irq_6 ” 618 is designated for sensor data pertaining to the accelerometer . “ irq_7 ” 620 is designated for sensor data pertaining to the gyroscope . “ irq_8 ” 622 is designated for the sensor data pertaining to the magnetometer . “ irq_9 ” 624 is designated to transmit data pertaining to distance . “ irq_10 ” 626 is designated for data pertaining to the heat slider . “ irq_11 ” 628 is designated for data pertaining to the fan slider , and “ irq_12 ” 630 is designated for data pertaining to the cold shot button . fig7 is a block diagram detailing the command type and payload in relation to the messaging and request processing queue of the drying / styling device . in accordance with the preferred embodiment of the present invention , the queue 700 is defined as the central message broker that manages requests for work units to be performed . the queue 700 acts as commands are produced 702 by interrupt events or the dryer module and are consumed 704 by the dryer module . commands are inserted in a first - come , first - served basis with the item at index 0 being the oldest . the queue 700 can either reside in the stack or heap , but the initial version of the product will allocate it in the stack so a fixed block memory can be statically allocated . as features are added , the expected time taken to process a command in the queue once it is added may increase . if this becomes too long , it may become desirable to split the queue into separate high priority and low priority queues where timing - critical applications are serviced first in the high - priority queue and work items of lesser importance are sent to the low priority queue . the queue stores timestamps associated with each command and can adapt behavior depending on load . for example , if the delta time from a command being inserted and serviced exceeds a threshold , other modules may be instructed to increase their period , more memory may be allocated for the queue ( for heap - based queues ), or certain modules may shut off entirely . the queue is made up of : the command type 702 , which indicates what type of command the structure represents ; and the command payload 704 , which indicates the type specific details that are required to service the command . there are currently 6 command types and 5 corresponding command payloads that are entered in the queue : the command “ type_read_sensor ” 706 requires that the bitmask of sensors are to be read 708 ; the command “ type_write_actuator ” 710 prompts for the enumerated actuator value as well as the value sent to the actuator depending on a variety of meanings 712 ; the command “ type_recv_packet ” 714 requires the receipt of the packet data 720 ; the command “ type_send_packet ” 718 prompts the packet data to be sent 724 ; the command “ type_log ” 722 prompts for access to the data log of the drying / styling device ; and the command “ type_invalid ” 726 does not have a corresponding payload command as it is defined as invalid . fig8 is a block diagram of the commands posted in the processing queue from the timer module . in accordance with the preferred embodiment of the present invention , the timer module 800 posts commands in the queue that direct the dryer module to perform certain actions at periodic intervals . these actions contain tasks such as sensor polling or flushing logs . the timer module commands include the following : “ static_void_init ” 802 , the command to initialize the timer module with the specific dryer instance , whereby the dryer &# 39 ; s queue must be in a non - constant state and is modified in response to timer events ; “ static_u32_now ” 804 , the command that returns the uptime of the product within milliseconds ; “ static_void_registersensorinterval ” 806 , the command that requests for a specific sensor to be read at the specified period whereby if the request is called multiple times for the same sensor , the most recent value is used ; “ static_void_handleexpiration ” 808 , the command for the timer interrupt service routine ( isr ) handler that determines which sensors need to be read at the time of expiration and posts a “ read_sensor ” command to the queue ; “ static_void_startperiodictimer ” 810 , the command that enables periodic timer interrupts whereby the specific timer period will be the greatest common divisor of the registered periods ; and “ static_void_stopperiodictimer ” 812 , the command to disable periodic timer interrupts . fig9 is a block diagram of specific , defined sensors that represent specific instantiations of the generic sensor types defined in fig5 . in accordance with the preferred embodiment of the present invention , the recognized data within the sensor 900 functionality are specified further and linked with the corresponding data modules . the data module for “ actuator_u16_t ” 902 relates to both the fan 904 and heater 906 actuators . the fan actuator 904 controls the fan speed request , whereby the value specified indicates the requested voltage to supply to the fan &# 39 ; s power rails depending on voltage units . the heat actuator 906 controls the heat temperature request , whereby the value specified indicates the requested voltage to supply to the heater &# 39 ; s power rails depending on voltage units . the data module for “ sensor_u16_t ” 908 relates to : “ type_near_temp ” 910 or the contact temperature sensor ; “ type_humidity ” 912 , the contact humidity sensor ; “ type_far_temp ” 914 , the contactless temperature sensor ; and “ type - distance ” 916 , the time of flight distance sensor . the data module for “ sensor_u16_3d_t ” 918 relates to : “ type_accelerometer ” 920 , the accelerometer sensor on the inertial measurement unit ( imu ) board ; “ type_gyroscope ” 922 , the gyroscope sensor on the imu board ; “ type_magnetometer ” 924 , the magnetometer sensor on the imu board ; and “ type_battery_level ” 926 , the amount of remaining battery power for cordless dryers consisting of the current voltage , the estimated time remaining and an alternative measuring capability . the data module for “ sensor_tristate_t ” 928 relates to : “ type_heat_slider ” 930 , the heat slider hardware control consisting of low , high , and auto heat settings ; and “ type_fan_slider ” 932 , the fan speed control slider hardware that consists of low , high , and auto speed settings . the data module for “ sensor_button_t ” 934 relates to “ type_cold_shot ” 936 , the cold shot button control . currently , all sensors are read via polling through the timer interface . future revisions of the product could allow the device to wake from a low - power sleep state through interrupts . for example , the device could automatically power on when picked up and power off when placed down by using the accelerometer sensor as an interrupt line . this would eliminate the need for the device to have an explicit power switch . fig1 is a schematic diagram of the heat element components used within the drying device . in accordance with the preferred embodiment of the present invention , the drying device utilizes a heating element that is made up of a fan and a connected motor that are housed within a motor shroud . a ceramic holder connects the fan and motor to the mica sheet structure heater . heat is generated within the mica sheet structure heater by an internal quartz infrared bulb that is held by the ceramic holder . air is drawn through the motor powered fan intake , and directed into the heater , heated up using the quartz infrared bulb and forced through the heater plates . fig1 is a set of images that demonstrates the light indicator functionality . in accordance with the preferred embodiment of the present invention , the light indicator displayed is a multi - colored status led could be used to determine the suitability of the current conditions . as shown in the image example , the green light indicates a suitable hair temperature , whereby the temperature emitted by the drying / styling device is below a pre - calculated threshold a . the yellow light indicates the upper end of the acceptable range , whereby the temperature emitted by the drying / styling device is between a and a higher calculated threshold b . the red light indicator could indicate the hair is too hot , whereby the temperature of the remote surface is above b . fig1 is a visual representation of the contactless infrared sensor functionality . in accordance with the preferred embodiment of the present invention , contactless infrared technology allows the temperature of a remote object to be measured without making physical contact with the object . the objective of the temperature sensor is to protect the hair , so the temperature of concern is the hair and not the dryer . from a usability standpoint , it is not ideal to place a sensor in physical contact with the hair . the relationship between the heater temperature and the hair temperature is not completely deterministic , since it depends on a variety of factors including the distance from the dryer to the hair , humidity of the room , and altitude . this means that estimates of the hair temperature are likely to have wide error margins that reduce the efficacy of the hair protecting solution . the displayed false - color photos show the electromagnetic radiation being emitted by a typical commercially available hair dryer and its result on a user &# 39 ; s hair . the tip of the dryer is closest to the heating element , so it is emitting the most , while the wall behind the dryer is emitting less . likewise , the emission from the hair i s maximized at the location the dryer is pointed . the first image displays a false - color infrared photograph of a profile view of a hair dryer while turned on . the second image displays the front view of a hair dryer while turned on , while the third image displays the user &# 39 ; s hair while a hair dryer is in use . fig1 shows a diagram showing the overview of how sensor and profile information can be shared across devices and locations . fig1 is a sketch showing various features of the invention . in some embodiments , the information can be used to build a profile of the user &# 39 ; s hair that can be stored on the styling or drying device , on a smartphone / tablet / laptop , or in the cloud . this profile information can be shared between various beauty products and can be used to recommend complementary products . when various devices are using the profile , they can adapt their behavior based on the information stored in the profile . for example , a consumer could purchase a hair dryer and configure it through a web site by uploading a picture of their hair and entering some additional information . once this profile has been created , the dryer could fine - tune the heat and airflow to customize the behavior for the consumer . in some embodiments , the same profile generated from the hair dryer may be used to customize the performance on other enhanced or smart devices . for example , if a consumer buys an enhanced flat iron , the use profile generated from the hair dryer could be used to customize the performance of the flat iron for their particular hair type . this process could be extended for other beauty products such as hot air brushes , curling irons and hot brushes . if the profile information is stored on the consumer &# 39 ; s smartphone or tablet or backed up in the cloud , then other devices could be customized to suit them . for example , a hotel dryer could be customized when it is in proximity of the consumer &# 39 ; s smartphone . in some embodiments , the invention may be used to define a profile for each user &# 39 ; s hair , consisting of : this profile can be used to configure parameters for various drying and styling devices . for example , thinner hair could cause a dryer to have a lower heat output since the additional heat may not be needed to dry the hair in a reasonable amount of time . the profile could also adapt over time — by measuring how long the consumer takes to dry their hair multiple times and monitoring environmental factors such as temperature and humidity during the process , the dryer can better learn to adapt to the user &# 39 ; s particular hair type . in some embodiments , the heating element could be controlled via sensors located on the device : contactless infrared thermometer — detect the remote temperature on the surface of the hair , shown in fig1 . contact thermometer ( e . g ., thermistor )— detect temperature of air exiting the dryer . ultrasonic sensor / time - of - flight light sensor — detect distance from tip of dryer to sensed object . can be used to detect distance from dryer to hair . inertial sensors — detect how quickly the dryer is being moved in space . in some embodiments , the proximal sensors could also be used to give a richer profile of the operating environment : in some embodiments , the invention provides significantly richer insights into the consumer &# 39 ; s usage habits than traditional beauty devices , additional feedback mechanisms are useful for communicating to the user in real - time . for example , if the user is holding the dryer too close to their hair or moving the flat iron too slowly and the hair could become damaged , it is desirable for the unit to provide feedback . the following feedback mechanisms have been contemplated : vibration motor — similar to a cell phone , the handle of the device could vibrate to indicate an undesirable state , shown in fig1 . led indicators — for units like flat irons where the consumer can often see the casing of the device , red / yellow / green status indicator leds can be used , shown in fig1 . buzzer / speaker — audible sounds / speech could be used to indicate certain conditions should change . proximal notifications — on the user &# 39 ; s phone , for example . stored in the user &# 39 ; s cloud profile for later coaching and feedback ( similar to fitbit but for styling ). there are different variations for the invention , for example , the hair styling devices could be : locally on the device . on a proximal smartphone , tablet , or laptop / desktop and synced via wi - fi / bluetooth . on a remote server in the cloud . control the heat output of products that could damage the hair . fine - tune the device to perform better on the consumer &# 39 ; s particular type of hair . coach the consumer by giving them feedback on their performance based on sensor measurements and comparisons to other consumers and / or professional consumers . recommend other products specific for the consumer &# 39 ; s hair type ( e . g ., other styling devices or consumables like hairspray , heat protectant , shampoo / conditioner , color treatment , etc .). directly ( e . g ., onboard wi - fi modem ). indirectly ( e . g ., via bluetooth to a smartphone / tablet and the smartphone / tablet connects to the internet ). the enhanced hair dryer disclosed herein is not obvious due to the following reasons : typical innovations in this space have focused around improving a single product such as a flat iron or hair dryer . embodiments of the invention takes a holistic approach and allows findings from one styling device to be applied to others . instead of imposing a one - size - fits - all solution as is common in the field , embodiments of the invention allows the same device to behave differently for different consumers based on their individual preferences . some embodiments of the invention leverages recent advancements in the internet of things and home automation to improving the hair drying / styling process . while various embodiments of the disclosed technology have been described above , it should be understood that they have been presented by way of example only , and not of limitation . likewise , the various diagrams may depict an example architectural or other configuration for the disclosed technology , which is done to aid in understanding the features and functionality that may be included in the disclosed technology . the disclosed technology is not restricted to the illustrated example architectures or configurations , but the desired features may be implemented using a variety of alternative architectures and configurations . indeed , it will be apparent to one of skill in the art how alternative functional , logical or physical partitioning and configurations may be implemented to implement the desired features of the technology disclosed herein . also , a multitude of different constituent module names other than those depicted herein may be applied to the various partitions . additionally , with regard to flow diagrams , operational descriptions and method claims , the order in which the steps are presented herein shall not mandate that various embodiments be implemented to perform the recited functionality in the same order unless the context dictates otherwise . although the disclosed technology is described above in terms of various exemplary embodiments and implementations , it should be understood that the various features , aspects and functionality described in one or more of the individual embodiments are not limited in their applicability to the particular embodiment with which they are described , but instead may be applied , alone or in various combinations , to one or more of the other embodiments of the disclosed technology , whether or not such embodiments are described and whether or not such features are presented as being a part of a described embodiment . thus , the breadth and scope of the technology disclosed herein should not be limited by any of the above - described exemplary embodiments . terms and phrases used in this document , and variations thereof , unless otherwise expressly stated , should be construed as open ended as opposed to limiting . as examples of the foregoing : the term “ including ” should be read as meaning “ including , without limitation ” or the like ; the term “ example ” is used to provide exemplary instances of the item in discussion , not an exhaustive or limiting list thereof ; the terms “ a ” or “ an ” should be read as meaning “ at least one ,” “ one or more ” or the like ; and adjectives such as “ conventional ,” “ traditional ,” “ normal ,” “ standard ,” “ known ” and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time , but instead should be read to encompass conventional , traditional , normal , or standard technologies that may be available or known now or at any time in the future . likewise , where this document refers to technologies that would be apparent or known to one of ordinary skill in the art , such technologies encompass those apparent or known to the skilled artisan now or at any time in the future . the presence of broadening words and phrases such as “ one or more ,” “ at least ,” “ but not limited to ” or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases may be absent . the use of the term “ module ” does not imply that the components or functionality described or claimed as part of the module are all configured in a common package . indeed , any or all of the various components of a module , whether control logic or other components , may be combined in a single package or separately maintained and can further be distributed in multiple groupings or packages or across multiple locations . additionally , the various embodiments set forth herein are described in terms of exemplary block diagrams , flow charts and other illustrations . as will become apparent to one of ordinary skill in the art after reading this document , the illustrated embodiments and their various alternatives may be implemented without confinement to the illustrated examples . for example , block diagrams and their accompanying description should not be construed as mandating a particular architecture or configuration . embodiments presented are particular ways to realize the invention and are not inclusive of all ways possible . therefore , there may exist embodiments that do not deviate from the spirit and scope of this disclosure as set forth by appended claims , but do not appear here as specific examples . it will be appreciated that a great plurality of alternative versions are possible .

US-201715663735-A

according to the present invention , compounds selected from the thiozole class of organic molecules are employed as antagonists for receptor - operated ion channels useful in the treatment of a variety of disease states in which roics are implicated . roics of particular interest are receptor - operated calcium channels . compounds of particular interest with respect to the subject invention are compounds of the thiazolidinedione class of organic molecules , more particularly ciglitazone . disease states in which particular utility is expected include vasculoproliferative diseases such as atherosclerosis , restenosis following angioplasty , and other conditions in which pdgf is known to play a role . the utility of the present invention with respect to further studies on the operation of roics and roccs and their role in disease will be apparent to those of skill in the art .

the compounds employed according to the subject invention , the thiazole class of organic compounds , are the subject of extensive disclosure in the literature and methods of synthesis are , therefore , known to those of skill in the art . of particular interest , however , are the disclosures of u . s . application ser . no . 07 / 421 , 102 , filed 13 oct . 1989 and u . s . application ser . no . 07 / 725 , 327 , filed 8 jul . 1991 , the disclosures of which are hereby incorporated by reference . the compounds of the subject invention are useful as antagonists of roccs which are implicated in a variety of tissues as indicated in table ii . the role of roccs in disease is only now being illucidated . for example , it is believed that the neurodegenerative effects of the human immunodeficiency virus ( hiv ) seen in many hiv infecteed patients is the result of the dysfunction of roccs in neurol tissue wherein the virus holds open roccs , causing the target cell to &# 34 ; flood &# 34 ; with calcium and ultimately die . the utility of roccs antagonists is obvious in such a condition . according to the subject invention , rocc antagonists are useful in modifying the effect of certain growth factors , particularly pdgf . pdgf is implicated in a variety of cardiovascular disease states including atherosclerosis , unstable angina , and restenosis following angioplasty . monoclonal antibodies to pdgf have been shown to inhibit neointimal smooth muscle accumulation following angioplasty . gordon , et al ., science ( 1991 ) 253 : 1129 - 32 . it is believed that efficacous doses of the compounds of the subject invention would have a similar effect on disease states wherein pdgf is implicated . an efficacous dose would be in the range of about 0 . 2 mg / kg to 100 mg / kg , particularly about 1 mg / kg to about 50 mg / kg , and more particularly about 2 mg / kg to 20 mg / kg . efficacy is defined as the modification of calcium or other ion transport across the cell membrane of host cells from the level of ion transport prior to the administration of the therapeutic agent . table ii______________________________________tissue diversity of ligand - activated , receptor - operated calciumchannels in mammalian cells ( partial list ) cell / tissue agonist ( examples ) ______________________________________human t lymphocyte pha , antibodies to cd2 , cd3 and t cell receptor epitopeshuman b lymphocyte anti ig antibodies , phahuman mast cell histaminehuman platelet thrombin , adpvascular smooth muscle norepinephrine , pdgf , endothelin - 1 , histamine , vasopressin , angiotensinileum smooth muscle acetylcholinehuman a172 glioma cell bradykinin , pdgfvascular endothelium thrombin , histamine edrf , nitric oxidehepatocyte vasopressinlacrimal acinar cell acetylcholineneutrophil fmlpj774 macrophage atpneural cells neurotransmitters endothelin - 1 , endothelin - 3bronchial smooth muscle endothelin - 1glomerular mesangial cells endothelinparotid cell muscarinic agonistshuman glioma endothelin______________________________________ pha = phytohemaglutinin ; ig = immunoglobulin ; fmlp = formylmethionyl - leucyl - phenylalanine ; atp = adenosine triphosphate ; edrf endotheliumderived relaxing factor ; adp = adenosine diphosphate a . effect of ciglitazone on the receptor - operated calcium channel agonist - induced ca 2 + ! i signal . the a172 human glioblastoma cell line was chosen to test the above - stated hypothesis for three reasons . first , the effects of pdgf on ca 2 + ! i in a172 cells has been studied in detail . second , the a172 cell does not contain voltage - sensitive calcium channels . third , pdgf was chosen for its diverse cellular effects , including vasoconstriction , chemotaxis , and cell growth . unless indicated otherwise , the methods employed in these studies are identical to those described in szollosi et al ., cell calcium ( 1991 ) 12 : 477 - 91 , the disclosures of which are hereby incorporated by reference . a172 cells were grown to approximately 95 % confluence and serum - starved for 4 . 5 hr prior to loading with the intracellular calcium indicator indo 1 by exposure to 3 μm of the acetoxymethyl ester ( indo 1 - am ). ciglitazone , dissolved in dimethylsulfoxide , was added to a final concentration of 2 μg / ml immediately before loading with indo 1 . the cells were incubated at 37 degrees for 45 min in an humidified incubator with 95 % air plus 5 % co 2 as gas phase . the extracellular fluid was removed , the cells washed thrice with serum - free medium , and reincubated for a further 30 min to ensure complete hydrolysis of the indo 1 - am . the cells were then analyzed individually in a laser scanning microspectrophotofluorometer . the effects of pdgf on ca 2 + ! i on a172 cells are shown in fig1 . the data shown is the sum of the signal obtained by scanning 8 adjacent cells . the vertical bar signifies the time at which pdgf ( 20 ng / ml ) was added to the well containing the cells . there is an initial delay followed by a sharp rise in ca 2 + ! i . the peak value was sustained for approximately 3 min and is followed by a slow , sustained decay in the calcium signal . the proof that the initial spike in al 72 cells is caused by the release of calcium from intracellular stores , and that the secondary sustained phase is the result of calcium entry via calcium channels located in the plasma membrane , is described in detail by szollosi , et al . the effect of pdgf on ca 2 + ! i on a172 cells pretreated with ciglitazone ( 2 μg / ml ) is shown in fig2 . treatment with ciglitazone had no significant effect on the unstimulated ( resting ) ca 2 + ! i , or peak value attained after addition of pdgf ( 20 ng / ml ). however , the calcium signal was truncated by abolition of the secondary sustained portion of the calcium signal , the portion caused by opening of plasma membrane calcium channels . the data shown in fig2 is the sum of the signal obtained by scanning 10 adjacent cells . the vertical bar shows the time at which pdgf was added . the effects of pdgf and ciglitazone on various parameters relating to ca 2 + ! i are summarized in table iii . the data was obtained by independently evaluating each of the 8 and 10 cells shown in fig1 and 2 , respectively . the data in table iii confirms the lack of a significant effect by ciglitazone on the pre - peak delay or the initial calcium peak response . on the other hand , the prolonged post - peak elevation in ca 2 + ! i was virtually eliminated at this concentration of ciglitazone ( fig1 ). these data indicate that the effect of ciglitazone was maximal at the concentration used ( 2 μg / ml ). table iii______________________________________effect of ciglitazone on the calcium signal induced by platelet - derivedgrowth factor control ciglitazone ( 2 μg / ml ) 20 ng / ml pdgf + 20 ng / ml pdgfparameter ( n = 8 ) ( n = 10 ) ______________________________________baseline calcium ratio * 0 . 67 +/- 0 . 01 0 . 68 +/- 0 . 01pre - peak dalay ( sec ) 57 +/- - 6 54 +/- 5peak response ( sec ) 1 . 0 +/- 0 . 1 1 . 1 +/- 0 . 1response duration ( sec ) 701 +/- 37 ** 172 +/- 15 ** ______________________________________ * calcium concentration is expressed as the ratio of ca2 +: indo 1 chelate t free ( umcomplexed ) indo 1 . absolute concentration of free calcium is proportional to this ratio . the pdgf used in these studies is the purifei bb homodimer ( g , pierce , amgen biologicals , thousand oaks , ca ). the vehicle for ciglitazone was used in control experiments . see text for further details . ** significance between control and ciglitazonetreated cells was p & lt ; 0 . 001 as determined by student &# 39 ; s paried ttest . the possibility that ciglitazone directly blocked pdgf - sensitive calcium channels was tested using the manganese maneuver in a172 cells loaded with indo - 1 ( szollosi et al ., supra ). partial quenching of the second phase calcium response suggested partial direct blockade of the pdgf - operated calcium channel . because , at the concentration of ciglitazone used , complete blockade of the second phase calcium response was achieved , the fact that a post - receptor effect of the drug is an inescapable conclusion . these seemingly disparate effects may simply be explained by a yet to be defmed structuravfunctional relationship between the agonist receptor and the coordinate rocc . genetic uniqueness in either or both of agonist / receptor or coupled calcium channel response could , in a general sense confer the molecular organization required for the kind of diversity obviously inherent in biological signals conveyed via roccs . similar experiments on the a172 glioma cells were conducted with bradykinin , another hormone that transmits its signal via increased ca 2 + ! i . the results were similar , namely , that ciglitazone blocked the second phase sustained plateau of ca 2 + ! i without significant effect on the initial peak response . interestingly , bradykinin has a vaso - relaxing effect on the vasculature , quite opposite to that of pdgf which is a vasoconstrictor . furthermore , bradykinin has analgesic effects via effects on the central nervous system . therefore , because of our findings with bradykinin and a172 cells , we also claim that thiazoles , appropriately designed , will prove a potential repository of therapeutically efficacious analgesic medicines . the findings described herein demonstrate that ciglitazone blocks the portion of the pdgf - stimulated calcium transient which is mediated by receptor - operated calcium channels in the plasma membrane of a172 human glioblastoma cells . the fact that the other parameters ( phases ) of the calcium signal remained unaffected strongly suggests that the effect of ciglitizone is highly selective . identical experiments were carried out on cultured a10 rat vascular smooth muscle cells ( vsmc ). the results were virtually identical to those obtained with the a172 cells , namely that ciglitazone eliminated the secondary sustained phase of the calcium transient induced by pdgf in vsmc . again , the effect of the ciglitazone appeared to be maximal at the concentration used ( 2 μg / ml ). ciglitazone inhibited pdgf - stimulated thymidine incorporation by approximately 55 % as shown in table iv . the inhibitory effects were similar at both drug concentrations , viz 0 . 5 and 2 . 0 μg / ml . these findings suggest that ciglitazone inhibits dna synthesis induced by pdgf . this is believed to be a consequence of the antagonist effect of the drug on pdgf operated calcium channels and suggests that ciglitazone would be expected to inhibit cell growth , proliferation , and / or migration via this effect . these data further suggest that blockade of pdgf receptor - operated calcium channels maybe ageneral property of the thiazoles , thus making them anovel class of calcium antagonists . while the precise mechanism is unknown the early data suggests a partial direct blockage of calcium entry across the cell membrane in cells having roccs . these findings imply that this novel class of calcium channel blockers may have therapeutic efficacy in a variety of cardiovascular pathologies , including hypertension , cardiac arrhythmia , coronary artery spasm , and atherosclerotic vascular disease . table iv______________________________________effect of ciglitazone on the incorporation of . sup . 3 h !- thymidine intohuman a172 glioma cellsserum dmso ciglitazone pdgf . sup . 3 h !- thymidine incorporation (%) (%) ( μg / ml ) ( ng / ml ) ( counts per minute ) ______________________________________10 . 0 none none none 26700 . 1 none none none 8400 . 1 0 . 5 none none 9100 . 1 none 0 . 5 none 8000 . 1 none 2 . 0 none 7800 . 1 none none 10 . 0 15600 . 1 0 . 5 none 10 . 0 14900 . 1 none 0 . 5 10 . 0 10900 . 1 none 2 . 0 10 . 0 1180______________________________________ nb : the values shown represent the mean of triplicate determinations ( internal error & lt ; 10 . 0 %). see text for further details . it will be apparent to those of skill in the art that the present invention adds to the state of the art the discovery of an entire new class of rocc antagonists useful in the treatment of a variety of disease states and the consequences of such disease . although the present invention has been described in some detail for the purposes of clarity and understanding , it will be obvious to those skilled in the art that certain changes and modifications may be practiced within the scope of the appended claims .

US-33734094-A

monoclonal antibodies that bind and inhibit activation of epidermal growth factor receptor related member erbb3 / her3 are disclosed . the antibodies can be used to treat cell proliferative diseases and disorders , including certain forms of cancer , associated with activation of erbb3 / her3 .

the erbb3 antibodies disclosed herein are based on the antigen binding sites of certain monoclonal antibodies selected for their ability to neutralize the biological activity of human erbb3 polypeptides . the antibodies contain immunoglobulin variable region cdr sequences that define a binding site for erbb3 . in some embodiments , the antibodies prevent erbb3 from binding to a ligand , e . g ., nrg / hrg , thereby neutralizing the biological activity of erbb3 . in other embodiments , the anti - erbb3 antibodies inhibit erbb3 dimerization , thereby neutralizing the biological activity of erbb3 . in still other embodiments , the anti - erbb3 antibodies inhibit phosphorylation of erbb3 and downstream signaling . because of the neutralizing activity of these antibodies , they are useful for inhibiting the growth and / or proliferation of certain cancer cells and tumors . the antibodies can be engineered to minimize or eliminate an immune response when administered to a human patient . in some embodiments , the antibodies are fused or conjugated to other moieties , such as detectable labels or effector molecules such as small molecule toxins . in some embodiments , the antibody comprises : ( a ) an immunoglobulin heavy chain variable region comprising the structure cdr h1 - cdr h2 - cdr h3 and ( b ) immunoglobulin light chain variable region , wherein the heavy chain variable region and the light chain variable region together define a single binding site for binding human erbb3 . a cdr h1 comprises an amino acid sequence selected from the group consisting of seq id no : 5 ( 04d01 ), seq id no : 15 ( 09d03 ), seq id no : 25 ( 11g01 ), seq id no : 34 ( 12a07 ), seq id no : 41 ( 18h02 ), seq id no : 51 ( 22a02 ), seq id no : 57 ( 24c05 ), and seq id no : 75 ( 24c05 ); a cdr h2 comprises an amino acid sequence selected from the group consisting of seq id no : 6 ( 04d01 ), seq id no : 16 ( 09d03 ), seq id no : 26 ( 11g01 ), seq id no : 35 ( 12a07 ), seq id no : 42 ( 18h02 ), seq id no : 52 ( 22a02 ), seq id no : 58 ( 24c05 ), and seq id no : 148 ( sh24c05 hv3 - 11 n62s ); and a cdr h3 comprises an amino acid sequence selected from the group consisting of seq id no : 7 ( 04d01 ), seq id no : 17 ( 09d03 ), seq id no : 27 ( 11g01 ), seq id no : 36 ( 12a07 , 22a02 ), seq id no : 43 ( 18h02 ), and seq id no : 59 ( 24c05 ). throughout the specification a particular seq id no . is followed in parentheses by the antibody that was the origin of that sequence . for example , “ seq id no : 5 ( 04d01 )” means that seq id no : 5 comes from antibody 04d01 . in some embodiments , the antibody comprises an immunoglobulin heavy chain variable region comprising a cdr h1 comprising the amino acid sequence of seq id no : 5 ( 04d01 ), a cdr h2 comprising the amino acid sequence of seq id no : 6 ( 04d01 ), and a cdr h3 comprising the amino acid sequence of seq id no : 7 ( 04d01 ). in some embodiments , the antibody comprises an immunoglobulin heavy chain variable region comprising a cdr h1 comprising the amino acid sequence of seq id no : 15 ( 09d03 ), a cdr h2 comprising the amino acid sequence of seq id no : 16 ( 09d03 ), and a cdr h3 comprising the amino acid sequence of seq id no : 17 ( 09d03 ). in some embodiments , the antibody comprises an immunoglobulin heavy chain variable region comprising a cdr h1 comprising the amino acid sequence of seq id no : 25 ( 11g01 ), a cdr h2 comprising the amino acid sequence of seq id no : 26 ( 11g01 ), and a cdr h3 comprising the amino acid sequence of seq id no : 27 ( 11g01 ). in some embodiments , the antibody comprises an immunoglobulin heavy chain variable region comprising a cdr h1 comprising the amino acid sequence of seq id no : 34 ( 12a07 ), a cdr h2 comprising the amino acid sequence of seq id no : 35 ( 12a07 ), and a cdr h3 comprising the amino acid sequence of seq id no : 36 ( 12a07 , 22a02 ). in some embodiments , the antibody comprises an immunoglobulin heavy chain variable region comprising a cdr h1 comprising the amino acid sequence of seq id no : 41 ( 18h02 ), a cdr h2 comprising the amino acid sequence of seq id no : 42 ( 18h02 ), and a cdr h3 comprising the amino acid sequence of seq id no : 43 ( 18h02 ). in some embodiments , the antibody comprises an immunoglobulin heavy chain variable region comprising a cdr h1 comprising the amino acid sequence of seq id no : 51 ( 22a02 ), a cdr h2 comprising the amino acid sequence of seq id no : 52 ( 22a02 ), and a cdr h3 comprising the amino acid sequence of seq id no : 36 ( 12a07 , 22a02 ). in some embodiments , the antibody comprises an immunoglobulin heavy chain variable region comprising a cdr h1 comprising the amino acid sequence of seq id no : 57 ( 24c05 ) or seq id no : 75 ( 24c05 ), a cdr h2 comprising the amino acid sequence of seq id no : 58 ( 24c05 ), and a cdr h3 comprising the amino acid sequence of seq id no : 59 ( 24c05 ). in certain embodiments , the antibody comprises an immunoglobulin heavy chain variable region comprising a cdr h1 comprising the amino acid sequence of seq id no : 57 ( 24c05 ), a cdr h2 comprising the amino acid sequence of seq id no : 58 ( 24c05 ), and a cdr h3 comprising the amino acid sequence of seq id no : 59 ( 24c05 ). in other embodiments , the antibody comprises an immunoglobulin heavy chain variable region comprising a cdr h1 comprising the amino acid sequence of seq id no : 75 ( 24c05 ), a cdr h2 comprising the amino acid sequence of seq id no : 58 ( 24c05 ), and a cdr h3 comprising the amino acid sequence of seq id no : 59 ( 24c05 ). in certain embodiments , the antibody comprises an immunoglobulin heavy chain variable region a cdr h1 comprising the amino acid sequence of seq id no : 57 ( 24c05 ) or seq id no : 75 ( 24c05 ), a cdr h2 comprising the amino acid sequence of seq id no : 148 ( sh24c05 hv3 - 11 n62s ), and a cdr h3 comprising the amino acid sequence of seq id no : 59 ( 24c05 ). preferably , the cdr h1 , cdr h2 , and cdr h3 sequences are interposed between human or humanized immunoglobulin frs . the antibody can be an intact antibody or an antigen - binding antibody fragment . in some embodiments , the antibody comprises ( a ) an immunoglobulin light chain variable region comprising the structure cdr l1 - cdr l2 - cdr l3 , and ( b ) an immunoglobulin heavy chain variable region , wherein the igg light chain variable region and the igg heavy chain variable region together define a single binding site for binding human erbb3 . a cdr l1 comprises an amino acid sequence selected from the group consisting of seq id no : 8 ( 04d01 , 12a07 , 22a02 ), seq id no : 18 ( 09d03 ), seq id no : 28 ( 11g01 ), seq id no : 44 ( 18h02 ), and seq id no : 60 ( 24c05 ); a cdr l2 comprises an amino acid sequence selected from the group consisting of seq id no : 9 ( 04d01 , 11g01 , 12a07 , 22a02 ), seq id no : 19 ( 09d03 ), seq id no : 45 ( 18h02 ), and seq id no : 61 ( 24c05 ); and a cdr l3 comprises an amino acid sequence selected from the group consisting of seq id no : 10 ( 04d01 , 12a07 , 22a02 ), seq id no : 20 ( 09d03 ), seq id no : 29 ( 11g01 ), seq id no : 46 ( 18h02 ), and seq id no : 62 ( 24c05 ). in some embodiments , the antibody comprises an immunoglobulin light chain variable region comprising : a cdr l1 comprising the amino acid sequence of seq id no : 8 ( 04d01 , 12a07 , 22a02 ); a cdr l2 comprising the amino acid sequence of seq id no : 9 ( 04d01 , 11g01 , 12a07 , 22a02 ); and a cdr l3 comprising the amino acid sequence of seq id no : 10 ( 04d01 , 12a07 , 22a02 ). in some embodiments , the antibody comprises an immunoglobulin light chain variable region comprising : a cdr l1 comprising the amino acid sequence of seq id no : 18 ( 09d03 ); a cdr l2 comprising the amino acid sequence of seq id no : 19 ( 09d03 ); and a cdr l3 comprising the amino acid sequence of seq id no : 20 ( 09d03 ). in some embodiments , the antibody comprises an immunoglobulin light chain variable region comprising : a cdr l1 comprising the amino acid sequence of seq id no : 28 ( 11g01 ); a cdr l2 comprising the amino acid sequence of seq id no : 9 ( 04d01 , 11g01 , 12a07 , 22a02 ); and a cdr l3 comprising the amino acid sequence of seq id no : 29 ( 11g01 ). in some embodiments , the antibody comprises an immunoglobulin light chain variable region comprising : a cdr l1 comprising the amino acid sequence of seq id no : 44 ( 18h02 ); a cdr l2 comprising the amino acid sequence of seq id no : 45 ( 18h02 ); and a cdr l3 comprising the amino acid sequence of seq id no : 46 ( 18h02 ). in one embodiment , the antibody comprises an immunoglobulin light chain variable region comprising : a cdr l1 comprising the amino acid sequence of seq id no : 60 ( 24c05 ); a cdr l2 comprising the amino acid sequence of seq id no : 61 ( 24c05 ); and a cdr l3 comprising the amino acid sequence of seq id no : 62 ( 24c05 ). preferably , the cdr l1 , cdr l2 , and cdr l3 sequences are interposed between human or humanized immunoglobulin frs . the antibody can be an intact antibody or an antigen - binding antibody fragment . in some embodiments , the antibody comprises : ( a ) an igg heavy chain variable region comprising the structure cdr h1 - cdr h2 - cdr h3 and ( b ) an igg light chain variable region comprising the structure cdr l1 - cdr l2 - cdr l3 , wherein the heavy chain variable region and the light chain variable region together define a single binding site for binding human erbb3 . the cdr h1 is an amino acid sequence selected from the group consisting of seq id no : 5 ( 04d01 ), seq id no : 15 ( 09d03 ), seq id no : 25 ( 11g01 ), seq id no : 34 ( 12a07 ), seq id no : 41 ( 18h02 ), seq id no : 51 ( 22a02 ), seq id no : 57 ( 24c05 ), and seq id no : 75 ( 24c05 ); the cdr h2 is an amino acid sequence selected from the group consisting of seq id no : 6 ( 04d01 ), seq id no : 16 ( 09d03 ), seq id no : 26 ( 11g01 ), seq id no : 35 ( 12a07 ), seq id no : 42 ( 18h02 ), seq id no : 52 ( 22a02 ), seq id no : 58 ( 24c05 ), and seq id no : 148 ( sh24c05 hv3 - 11 n62s ); and the cdr h3 is an amino acid sequence selected from the group consisting of seq id no : 7 ( 04d01 ), seq id no : 17 ( 09d03 ), seq id no : 27 ( 11g01 ), seq id no : 36 ( 12a07 , 22a02 ), seq id no : 43 ( 18h02 ), and seq id no : 59 ( 24c05 ). the cdr l1 is an amino acid sequence selected from the group consisting of seq id no : 8 ( 04d01 , 12a07 , 22a02 ), seq id no : 18 ( 09d03 ), seq id no : 28 ( 11g01 ), seq id no : 44 ( 18h02 ), and seq id no : 60 ( 24c05 ); the cdr l2 is an amino acid sequence selected from the group consisting of seq id no : 9 ( 04d01 , 11g01 , 12a07 , 22a02 ), seq id no : 19 ( 09d03 ), seq id no : 45 ( 18h02 ), and seq id no : 61 ( 24c05 ); and the cdr l3 is an amino acid sequence selected from the group consisting of seq id no : 10 ( 04d01 , 12a07 , 22a02 ), seq id no : 20 ( 09d03 ), seq id no : 29 ( 11g01 ), seq id no : 46 ( 18h02 ), and seq id no : 62 ( 24c05 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain variable region selected from the group consisting of seq id no : 2 ( 04d01 ), seq id no : 12 ( 09d03 ), seq id no : 22 ( 11g01 ), seq id no : 31 ( 12a07 ), seq id no : 38 ( 18h02 ), seq id no : 48 ( 22a02 ), seq id no : 54 ( 24c05 ), and seq id no : 154 ( sh24c05 hv3 - 11 n62s ), and an immunoglobulin light chain variable region selected from the group consisting of seq id no : 4 ( 04d01 ), seq id no : 14 ( 09d03 ), seq id no : 24 ( 11g01 ), seq id no : 33 ( 12a07 ), seq id no : 40 ( 18h02 ), seq id no : 50 ( 22a02 ), seq id no : 56 ( 24c05 ), seq id no : 166 ( sh24c05 kv1 - 16 ), and seq id no : 168 ( sh24c05 kv1 - 17 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain variable region comprising the amino acid sequence of seq id no : 2 ( 04d01 ), and an immunoglobulin light chain variable region comprising the amino acid sequence of seq id no : 4 ( 04d01 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain variable region comprising the amino acid sequence of seq id no : 12 ( 09d03 ), and an immunoglobulin light chain variable region comprising the amino acid sequence of seq id no : 14 ( 09d03 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain variable region comprising the amino acid sequence of seq id no : 22 ( 11g01 ), and an immunoglobulin light chain variable region comprising the amino acid sequence of seq id no : 24 ( 11g01 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain variable region comprising the amino acid sequence of seq id no : 31 ( 12a07 ), and an immunoglobulin light chain variable region comprising the amino acid sequence of seq id no : 33 ( 12a07 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain variable region comprising the amino acid sequence of seq id no : 38 ( 18h02 ), and an immunoglobulin light chain variable region comprising the amino acid sequence of seq id no : 40 ( 18h02 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain variable region comprising the amino acid sequence of seq id no : 48 ( 22a02 ), and an immunoglobulin light chain variable region comprising the amino acid sequence of seq id no : 50 ( 22a02 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain variable region comprising the amino acid sequence of seq id no : 54 ( 24c05 ), and an immunoglobulin light chain variable region comprising the amino acid sequence of seq id no : 56 ( 24c05 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain variable region comprising the amino acid sequence of seq id no : 154 ( sh24c05 hv3 - 11 n62s ), and an immunoglobulin light chain variable region comprising the amino acid sequence of seq id no : 166 ( sh24c05 kv1 - 16 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain variable region comprising the amino acid sequence of seq id no : 154 ( sh24c05 hv3 - 11 n62s ), and an immunoglobulin light chain variable region comprising the amino acid sequence of seq id no : 168 ( sh24c05 kv1 - 17 ). in other embodiments , the antibody comprises ( i ) an immunoglobulin heavy chain selected from the group consisting of seq id no : 109 ( 04d01 ), seq id no : 113 ( 09d03 ), seq id no : 117 ( 11g01 ), seq id no : 121 ( 12a07 ), seq id no : 125 ( 18h02 ), seq id no : 129 ( 22a07 ), seq id no : 133 ( 24c05 ), seq id no : 190 ( sh24c05 hv3 - 11 n62s igg1 ), and seq id no : 192 ( sh24c05 hv3 - 11 n62s igg2 ), and ( ii ) an immunoglobulin light chain selected from the group consisting of seq id no : 111 ( 04d01 ), seq id no : 115 ( 09d03 ), seq id no : 119 ( 11g01 ), seq id no : 123 ( 12a07 ), seq id no : 127 ( 18h02 ), seq id no : 131 ( 22a07 ), seq id no : 135 ( 24c05 ), seq id no : 204 ( sh24c05 kv1 - 16 kappa ), and seq id no : 206 ( sh24c05 kv1 - 17 kappa ). in another embodiment , the antibody comprises an immunoglobulin heavy chain comprising the amino acid sequence of seq id no : 109 ( 04d01 ), and an immunoglobulin light chain comprising the amino acid sequence of seq id no : 111 ( 04d01 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain comprising the amino acid sequence of seq id no : 113 ( 09d03 ), and an immunoglobulin light chain comprising the amino acid sequence of seq id no : 115 ( 09d03 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain comprising the amino acid sequence of seq id no : 117 ( 11g01 ), and an immunoglobulin light chain comprising the amino acid sequence of seq id no : 119 ( 11g01 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain comprising the amino acid sequence of seq id no : 121 ( 12a07 ), and an immunoglobulin light chain comprising the amino acid sequence of seq id no : 123 ( 12a07 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain comprising the amino acid sequence of seq id no : 125 ( 18h02 ), and an immunoglobulin light chain comprising the amino acid sequence of seq id no : 127 ( 18h02 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain comprising the amino acid sequence of seq id no : 129 ( 22a02 ), and an immunoglobulin light chain comprising the amino acid sequence of seq id no : 131 ( 22a02 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain comprising the amino acid sequence of seq id no : 133 ( 24c05 ), and an immunoglobulin light chain comprising the amino acid sequence of seq id no : 135 ( 24c05 ). in another embodiment , the antibody comprises an immunoglobulin heavy chain comprising the amino acid sequence of seq id no : 190 ( sh24c05 hv3 - 11 n62s igg1 ), and an immunoglobulin light chain comprising the amino acid sequence of seq id no : 204 ( sh24c05 kv1 - 16 kappa ). in another embodiment , the antibody comprises an immunoglobulin heavy chain comprising the amino acid sequence of seq id no : 192 ( sh24c05 hv3 - 11 n62s igg2 ), and an immunoglobulin light chain comprising the amino acid sequence of seq id no : 204 ( sh24c05 kv1 - 16 kappa ). in another embodiment , the antibody comprises an immunoglobulin heavy chain comprising the amino acid sequence of seq id no : 190 ( sh24c05 hv3 - 11 n62s igg1 ), and an immunoglobulin light chain comprising the amino acid sequence of seq id no : 206 ( sh24c05 kv1 - 17 kappa ). in another embodiment , the antibody comprises an immunoglobulin heavy chain comprising the amino acid sequence of seq id no : 192 ( sh24c05 hv3 - 11 n62s igg2 ), and an immunoglobulin light chain comprising the amino acid sequence of seq id no : 206 ( sh24c05 kv1 - 17 kappa ). as used herein , unless otherwise indicated , the term “ antibody ” means an intact antibody ( e . g ., an intact monoclonal antibody ) or antigen - binding fragment of a antibody ( e . g ., an antigen - binding fragment of a monoclonal antibody ), including an intact antibody or antigen - binding fragment that has been modified , engineered , or chemically conjugated . examples of antibodies that have been modified or engineered include chimeric antibodies , humanized antibodies , and multispecific antibodies ( e . g ., bispecific antibodies ). examples of antigen - binding fragments include fab , fab ′, ( fab ′) 2 , fv , single chain antibodies ( e . g ., scfv ), minibodies , and diabodies . an example of a chemically conjugated antibody is an antibody conjugated to a toxin moiety . fig1 shows a schematic representation of an intact monoclonal antibody that contains four polypeptide chains . two of the polypeptide chains are called immunoglobulin heavy chains ( h chains ), and two of the polypeptide chains are called immunoglobulin light chains ( l chains ). the immunoglobulin heavy and light chains are connected by an interchain disulfide bond . the immunoglobulin heavy chains are connected by interchain disulfide bonds . a light chain consists of one variable region ( v l in fig1 ) and one constant region ( c l in fig1 ). the heavy chain consists of one variable region ( v h in fig1 ) and at least three constant regions ( ch 1 , ch 2 and ch 3 in fig1 ). the variable regions determine the specificity of the antibody . each variable region contains three hypervariable regions known as complementarity determining regions ( cdrs ) flanked by four relatively conserved regions known as framework regions ( frs ). the three cdrs , referred to as cdr 1 , cdr 2 , and cdr 3 , contribute to the antibody binding specificity . in certain embodiments , an isolated antibody that binds human erbb3 comprises an immunoglobulin heavy chain variable region comprising an amino acid sequence that is at least 70 %, 75 %, 80 %, 85 %, 90 %, 95 %, 98 %, or 99 % identical to the entire variable region or the framework region sequence of seq id no : 2 ( 04d01 ), seq id no : 12 ( 09d03 ), seq id no : 22 ( 11g01 ), seq id no : 31 ( 12a07 ), seq id no : 38 ( 18h02 ), seq id no : 48 ( 22a02 ), seq id no : 54 ( 24c05 ), and seq id no : 154 ( sh24c05 hv3 - 11 n62s ). in certain embodiments , an isolated antibody that binds human erbb3 comprises an immunoglobulin light chain variable region comprising an amino acid sequence that is at least 70 %, 75 %, 80 %, 85 %, 90 %, 95 %, 98 %, or 99 % identical to the entire variable region or the framework region sequence of seq id no : 4 ( 04d01 ), seq id no : 14 ( 09d03 ), seq id no : 24 ( 11g01 ), seq id no : 33 ( 12a07 ), seq id no : 40 ( 18h02 ), seq id no : 50 ( 22a02 ), seq id no : 56 ( 24c05 ), seq id no : 166 ( sh24c05 kv1 - 16 ), and seq id no : 168 ( sh24c05 kv1 - 17 ). in each of the foregoing embodiments , it is contemplated herein that immunoglobulin heavy chain variable region sequences and / or light chain variable region sequences that together bind human erbb3 may contain amino acid alterations ( e . g ., at least 1 , 2 , 3 , 4 , 5 , or 10 amino acid substitutions , deletions , or additions ) in the framework regions of the heavy and / or light chain variable regions . in some embodiments , an isolated antibody binds herbb3 with a k d of 350 pm , 300 pm , 250 pm , 200 pm , 150 pm , 100 pm , 75 pm , 50 pm , 20 pm , 10 pm or lower . unless otherwise specified , k d values are determined by surface plasmon resonance methods . the surface plasmon resonance methods can be performed using the conditions described , for example , in examples 3 and 12 , where the measurements were performed at 25 ° c . and 37 ° c ., respectively . in some embodiments , the antibodies inhibit herbb3 binding to nrg1 - β1 . for example , the antibodies can have an ic 50 ( concentration at 50 % of maximum inhibition ) of about 5 nm , 2 nm or lower , when assayed using the protocols described in examples 4 and 13 . methods for producing antibodies disclosed herein are known in the art . for example , dna molecules encoding light chain variable regions and heavy chain variable regions can be chemically synthesized using the sequence information provided herein . synthetic dna molecules can be ligated to other appropriate nucleotide sequences , including , e . g ., constant region coding sequences , and expression control sequences , to produce conventional gene expression constructs encoding the desired antibodies . production of defined gene constructs is within routine skill in the art . alternatively , the sequences provided herein can be cloned out of hybridomas by conventional hybridization techniques or polymerase chain reaction ( pcr ) techniques , using synthetic nucleic acid probes whose sequences are based on sequence information provided herein , or prior art sequence information regarding genes encoding the heavy and light chains of murine antibodies in hybridoma cells . nucleic acids encoding the antibodies disclosed herein can be incorporated ( ligated ) into expression vectors , which can be introduced into host cells through conventional transfection or transformation techniques . exemplary host cells are e . coli cells , chinese hamster ovary ( cho ) cells , hela cells , baby hamster kidney ( bhk ) cells , monkey kidney cells ( cos ), human hepatocellular carcinoma cells ( e . g ., hep g2 ), and myeloma cells that do not otherwise produce igg protein . transformed host cells can be grown under conditions that permit the host cells to express the genes that encode the immunoglobulin light and / or heavy chain variable regions . specific expression and purification conditions will vary depending upon the expression system employed . for example , if a gene is to be expressed in e . coli , it is first cloned into an expression vector by positioning the engineered gene downstream from a suitable bacterial promoter , e . g ., tip or tac , and a prokaryotic signal sequence . the expressed secreted protein accumulates in refractile or inclusion bodies , and can be harvested after disruption of the cells by french press or sonication . the refractile bodies then are solubilized , and the proteins refolded and cleaved by methods known in the art . if a dna construct encoding an antibody disclosed herein is to be expressed in eukayotic host cells , e . g ., cho cells , it is first inserted into an expression vector containing a suitable eukaryotic promoter , a secretion signal , igg enhancers , and various introns . this expression vector optionally contains sequences encoding all or part of a constant region , enabling an entire , or a part of , a heavy and / or light chain to be expressed . in some embodiments , a single expression vector contains both heavy and light chain variable regions to be expressed . the gene construct can be introduced into eukaryotic host cells using conventional techniques . the host cells express v l or v h fragments , v l - v h heterodimers , v h - v l or v l - v h single chain polypeptides , complete heavy or light immunoglobulin chains , or portions thereof , each of which may be attached to a moiety having another function ( e . g ., cytotoxicity ). in some embodiments , a host cell is transfected with a single vector expressing a polypeptide expressing an entire , or part of , a heavy chain ( e . g ., a heavy chain variable region ) or a light chain ( e . g ., a light chain variable region ). in other embodiments , a host cell is transfected with a single vector encoding ( a ) a polypeptide comprising a heavy chain variable region and a polypeptide comprising a light chain variable region , or ( b ) an entire immunoglobulin heavy chain and an entire immunoglobulin light chain . in still other embodiments , a host cell is co - transfected with more than one expression vector ( e . g ., one expression vector expressing a polypeptide comprising an entire , or part of , a heavy chain or heavy chain variable region , and another expression vector expressing a polypeptide comprising an entire , or part of , a light chain or light chain variable region ). a method of producing a polypeptide comprising an immunoglobulin heavy chain variable region or a polypeptide comprising an immunoglobulin light chain variable region may comprise growing a host cell transfected with an expression vector under conditions that permits expression of the polypeptide comprising the immunoglobulin heavy chain variable region or the polypeptide comprising the immunoglobulin light chain variable region . the polypeptide comprising a heavy chain variable region or the polypeptide comprising the light chain variable region then may be purified using techniques well known in the art , e . g ., affinity tags such as glutathione - s - transferase ( gst ) and histidine tags . a method of producing a monoclonal antibody that binds human erbb3 , or an antigen - binding fragment of the antibody , may comprise growing a host cell transfected with : ( a ) an expression vector that encodes a complete or partial immunoglobulin heavy chain , and a separate expression vector that encodes a complete or partial immunoglobulin light chain ; or ( b ) a single expression vector that encodes both chains ( e . g ., complete or partial chains ), under conditions that permit expression of both chains . the intact antibody ( or antigen - binding fragment ) can be harvested and purified using techniques well known in the art , e . g ., protein a , protein g , affinity tags such as glutathione - s - transferase ( gst ) and histidine tags . it is within ordinary skill in the art to express the heavy chain and the light chain from a single expression vector or from two separate expression vectors . methods for reducing or eliminating the antigenicity of antibodies and antibody fragments are known in the art . when the antibodies are to be administered to a human , the antibodies preferably are “ humanized ” to reduce or eliminate antigenicity in humans . preferably , a humanized antibody has the same or substantially the same affinity for the antigen as the non - humanized mouse antibody from which it was derived . in one humanization approach , chimeric proteins are created in which mouse immunoglobulin constant regions are replaced with human immunoglobulin constant regions . see , e . g ., morrison et al ., 1984 , p roc . n at . a cad . s ci . 81 : 6851 - 6855 , neuberger et al ., 1984 , n ature 312 : 604 - 608 ; u . s . pat . no . 6 , 893 , 625 ( robinson ); u . s . pat . no . 5 , 500 , 362 ( robinson ); and u . s . pat . no . 4 , 816 , 567 ( cabilly ). in an approach known as cdr grafting , the cdrs of the light and heavy chain variable regions are grafted into frameworks from another species . for example , murine cdrs can be grafted into human frs . in some embodiments , the cdrs of the light and heavy chain variable regions of an anti - erbb3 antibody are grafted onto human frs or consensus human frs . to create consensus human frs , frs from several human heavy chain or light chain amino acid sequences are aligned to identify a consensus amino acid sequence . cdr grafting is described in u . s . pat . no . 7 , 022 , 500 ( queen ); u . s . pat . no . 6 , 982 , 321 ( winter ); u . s . pat . no . 6 , 180 , 370 ( queen ); u . s . pat . no . 6 , 054 , 297 ( carter ); u . s . pat . no . 5 , 693 , 762 ( queen ); u . s . pat . no . 5 , 859 , 205 ( adair ); u . s . pat . no . 5 , 693 , 761 ( queen ); u . s . pat . no . 5 , 565 , 332 ( hoogenboom ); u . s . pat . no . 5 , 585 , 089 ( queen ); u . s . pat . no . 5 , 530 , 101 ( queen ); jones et al . ( 1986 ) n ature 321 : 522 - 525 ; riechmann et al . ( 1988 ) n ature 332 : 323 - 327 ; verhoeyen et al . ( 1988 ) s cience 239 : 1534 - 1536 ; and winter ( 1998 ) febs l ett 430 : 92 - 94 . in an approach called “ superhumanization ™,” human cdr sequences are chosen from human germline genes , based on the structural similarity of the human cdrs to those of the mouse antibody to be humanized . see , e . g ., u . s . pat . no . 6 , 881 , 557 ( foote ); and tan et al ., 2002 , j . i mmunol 169 : 1119 - 1125 . other methods to reduce immunogenicity include “ reshaping ,” “ hyperchimerization ,” and “ veneering / resurfacing .” see , e . g ., vaswami et al ., 1998 , a nnals of allergy , asthma , & amp ; i mmunol . 81 : 105 ; roguska et al ., 1996 , p rot . e ngineer 9 : 895 - 904 ; and u . s . pat . no . 6 , 072 , 035 ( hardman ). in the veneering / resurfacing approach , the surface accessible amino acid residues in the murine antibody are replaced by amino acid residues more frequently found at the same positions in a human antibody . this type of antibody resurfacing is described , e . g ., in u . s . pat . no . 5 , 639 , 641 ( pedersen ). another approach for converting a mouse antibody into a form suitable for medical use in humans is known as activmab ™ technology ( vaccinex , inc ., rochester , n . y . ), which involves a vaccinia virus - based vector to express antibodies in mammalian cells . high levels of combinatorial diversity of igg heavy and light chains are said to be produced . see , e . g ., u . s . pat . no . 6 , 706 , 477 ( zauderer ); u . s . pat . no . 6 , 800 , 442 ( zauderer ); and u . s . pat . no . 6 , 872 , 518 ( zauderer ). another approach for converting a mouse antibody into a form suitable for use in humans is technology practiced commercially by kalobios pharmaceuticals , inc . ( palo alto , calif .). this technology involves the use of a proprietary human “ acceptor ” library to produce an “ epitope focused ” library for antibody selection . another approach for modifying a mouse antibody into a form suitable for medical use in humans is human engineering ™ technology , which is practiced commercially by xoma ( us ) llc . see , e . g ., pct publication no . wo 93 / 11794 and u . s . pat . nos . 5 , 766 , 886 ; 5 , 770 , 196 ; 5 , 821 , 123 ; and 5 , 869 , 619 . any suitable approach , including any of the above approaches , can be used to reduce or eliminate human immunogenicity of an antibody disclosed herein . methods of making multispecific antibodies are known in the art . multi - specific antibodies include bispecific antibodies . bispecific antibodies are antibodies that have binding specificities for at least two different epitopes . exemplary bispecific antibodies bind to two different epitopes of the antigen of interest . bispecific antibodies can be prepared as full length antibodies or antibody fragments ( e . g ., f ( ab ′) 2 bispecific antibodies and diabodies ) as described , for example , in milstein et al ., n ature 305 : 537 - 539 ( 1983 ), wo 93 / 08829 , traunecker et al ., embo j ., 10 : 3655 - 3659 ( 1991 ), wo 94 / 04690 , suresh et al ., m ethods in e nzymology , 121 : 210 ( 1986 ), wo96 / 27011 , brennan et al ., s cience , 229 : 81 ( 1985 ), shalaby et al ., j . e xp . m ed ., 175 : 217 - 225 ( 1992 ), kostelny et al ., j . i mmunol ., 148 ( 5 ): 1547 - 1553 ( 1992 ), hollinger et al ., pnas , 90 : 6444 - 6448 , gruber et al ., j . i mmunol ., 152 : 5368 ( 1994 ), wu et al ., nat . b iotechnol ., 25 ( 11 ): 1290 - 1297 , u . s . patent publication no . 2007 / 0071675 , and bostrom et al ., s cience 323 : 1640 - 1644 ( 2009 ). in some embodiments , the antibody is conjugated to an effector agent such as a small molecule toxin or a radionuclide using standard in vitro conjugation chemistries . if the effector agent is a polypeptide , the antibody can be chemically conjugated to the effector or joined to the effector as a fusion protein . construction of fusion proteins is within ordinary skill in the art . the antibodies disclosed herein can be used to treat various forms of cancer , e . g ., breast , ovarian , prostate , cervical , colorectal , lung ( e . g ., non - small cell lung cancer ), pancreatic , gastric , skin , kidney , head and neck , and schwannoma cancers . the cancer cells are exposed to a therapeutically effective amount of the antibody so as to inhibit or reduce proliferation of the cancer cell . in some embodiments , the antibodies inhibit cancer cell proliferation by at least 40 %, 50 %, 60 %, 70 %, 80 %, 90 %, 95 %, 98 %, 99 %, or 100 %. in some embodiments , the antibody inhibits or reduces proliferation of a tumor cell by inhibiting binding of human erbb3 to an erbb3 ligand , e . g ., neuregulin / heregulin especially nrgβ1 / nrg1 - β1 / nrgβ1 / hrgβ1 and nrgα1 / nrg1 - α1 / nrgα1 / hrgα1 . the antibody can be used in a method to inhibit tumor growth in a human patient . the method comprises administering to the patient a therapeutically effective amount of the antibody . cancers associated with erbb3 overexpression and / or activation include breast cancer , ovarian cancer , prostate cancer , cervical cancer , lung cancer ( e . g ., non - small cell lung cancer ), some forms of brain cancer ( e . g ., schwannoma ), melanomas , skin , kidney , and gastrointestinal cancers ( e . g ., colorectal , pancreatic , gastric , head and neck ). as used herein , “ treat , “ treating ” and “ treatment ” mean the treatment of a disease in a mammal , e . g ., in a human . this includes : ( a ) inhibiting the disease , i . e ., arresting its development ; and ( b ) relieving the disease , i . e ., causing regression of the disease state ; and ( c ) curing the disease . generally , a therapeutically effective amount of active component is in the range of 0 . 1 mg / kg to 100 mg / kg , e . g ., 1 mg / kg to 100 mg / kg , 1 mg / kg to 10 mg / kg . the amount administered will depend on variables such as the type and extent of disease or indication to be treated , the overall health of the patient , the in vivo potency of the antibody , the pharmaceutical formulation , and the route of administration . the initial dosage can be increased beyond the upper level in order to rapidly achieve the desired blood - level or tissue level . alternatively , the initial dosage can be smaller than the optimum , and the daily dosage may be progressively increased during the course of treatment . human dosage can be optimized , e . g ., in a conventional phase i dose escalation study designed to run from 0 . 5 mg / kg to 20 mg / kg . dosing frequency can vary , depending on factors such as route of administration , dosage amount and the disease being treated . exemplary dosing frequencies are once per day , once per week and once every two weeks . a preferred route of administration is parenteral , e . g ., intravenous infusion . formulation of monoclonal antibody - based drugs is within ordinary skill in the art . in some embodiments , the monoclonal antibody is lyophilized and reconstituted in buffered saline at the time of administration . for therapeutic use , an antibody preferably is combined with a pharmaceutically acceptable carrier . as used herein , “ pharmaceutically acceptable carrier ” means buffers , carriers , and excipients suitable for use in contact with the tissues of human beings and animals without excessive toxicity , irritation , allergic response , or other problem or complication , commensurate with a reasonable benefit / risk ratio . the carrier ( s ) should be “ acceptable ” in the sense of being compatible with the other ingredients of the formulations and not deleterious to the recipient . pharmaceutically acceptable carriers include buffers , solvents , dispersion media , coatings , isotonic and absorption delaying agents , and the like , that are compatible with pharmaceutical administration . the use of such media and agents for pharmaceutically active substances is known in the art . pharmaceutical compositions containing antibodies disclosed herein can be presented in a dosage unit form and can be prepared by any suitable method . a pharmaceutical composition should be formulated to be compatible with its intended route of administration . examples of routes of administration are intravenous ( iv ), intradermal , inhalation , transdermal , topical , transmucosal , and rectal administration . a preferred route of administration for monoclonal antibodies is iv infusion . useful formulations can be prepared by methods well known in the pharmaceutical art . for example , see remington &# 39 ; s pharmaceutical sciences , 18th ed . ( mack publishing company , 1990 ). formulation components suitable for parenteral administration include a sterile diluent such as water for injection , saline solution , fixed oils , polyethylene glycols , glycerine , propylene glycol or other synthetic solvents ; antibacterial agents such as benzyl alcohol or methyl parabens ; antioxidants such as ascorbic acid or sodium bisulfite ; chelating agents such as edta ; buffers such as acetates , citrates or phosphates ; and agents for the adjustment of tonicity such as sodium chloride or dextrose . for intravenous administration , suitable carriers include physiological saline , bacteriostatic water , cremophor el ™ ( basf , parsippany , n . j .) or phosphate buffered saline ( pbs ). the carrier should be stable under the conditions of manufacture and storage , and should be preserved against microorganisms . the carrier can be a solvent or dispersion medium containing , for example , water , ethanol , polyol ( for example , glycerol , propylene glycol , and liquid polyetheylene glycol ), and suitable mixtures thereof . pharmaceutical formulations preferably are sterile . sterilization can be accomplished , for example , by filtration through sterile filtration membranes . where the composition is lyophilized , filter sterilization can be conducted prior to or following lyophilization and reconstitution . the following examples are merely illustrative and are not intended to limit the scope or content of the invention in any way . immunizations , fusions , and primary screens were conducted at maine biotechnology services inc . following the repetitive immunization multiple sites ( rimms ) protocol . three aj mice and three balb / c mice were immunized with recombinant human erbb3 / fc ( r & amp ; d systems , cat . no . 348 - rb ). two sets of immunization were performed with either cleaved rherbb3 ( immunization a ) or with cleaved rherbb3 cross - linked to its ligand , recombinant human nrg1 - β1 / hrg1 - β1 - egf domain ( r & amp ; d systems , cat . no . 396 - hb ) ( immunization b ). two aj mice per immunization with sera displaying high anti - erbb3 activity by enzyme linked immunosorbent assay ( elisa ) were chosen for subsequent fusion . spleens and lymph nodes from the appropriate mice were harvested . b - cells then were harvested and fused with a myeloma line . fusion products were serially diluted onto forty 96 - well plates to near clonality . a total of 5280 supernatants from the resulting fusions were screened for binding to recombinant rherbb3 / fc , using elisa . the same supernatants were also screened for their binding to human erbb3 overexpressed in cho cells ( by mesoscale electrochemiluminescence assay ). three hundred supernatants identified as containing antibodies against erbb3 were further characterized by in vitro biochemical and cell - based assays as discussed below . a panel of hybridomas was selected , and the hybridomas were subcloned and expanded . hybridoma cell lines were transferred to bioxcell ( formerly bio - express ) for antibody expression and purification by affinity chromatography on protein g resin under standard conditions . anti - herbb3 monoclonal antibody 04d01 was generated from immunization a described above . anti - herbb3 monoclonal antibodies 09d03 , 11g01 , 12a07 , 18h02 , 22a02 and 24c05 were generated from immunization b described above . the light - chain isotype and heavy chain isotype of each monoclonal antibody in example 1 was determined using the isostrip ™ mouse monoclonal antibody isotyping kit according the manufacturer &# 39 ; s instructions ( roche applied science ). all antibodies were determined to be kappa light chain and igg1 or igg2b igg heavy chain . the heavy and light chain variable regions of the mouse monoclonal antibodies were sequenced using 5 ′ race ( rapid amplification of cdna ends ). total rna was extracted from each monoclonal hybridoma cell line using the rneasy ® miniprep kit according to the vendor &# 39 ; s instructions ( qiagen ). full - length first strand cdna containing 5 ′ ends was generated using either the generacer ™ kit ( invitrogen ) or smarter ™ race cdna amplification kit ( clontech ) according to the manufacturer &# 39 ; s instructions using random primers for 5 ′ race . the variable regions of the kappa and heavy ( igg1 or igg2b ) igg chains were amplified by pcr , using kod hot start polymerase ( novagen ) or advantage 2 polymerase mix ( clontech ) according to the manufacturer &# 39 ; s instructions . for amplification of 5 ′ cdna ends in conjunction with the generacer ™ kit , the generacer ™ 5 ′ primer , 5 ′ cgactggagcacgaggacactga 3 ′ ( seq id no : 136 ) ( invitrogen ) was used as a 5 ′ primer . for amplification of 5 ′ cdna ends in conjunction with the smarter ™ race cdna amplification kit , the universal primer mix a primer ( clontech ), a mix of 5 ′ ctaatacgactcactatagggcaagcagtggtatcaacgcagagt 3 ′ ( seq id no : 137 ) and 5 ′ ctaatacgactcactatagggc 3 ′ ( seq id no : 138 ), was used as a 5 ′ primer . heavy chain variable regions were amplified using the above 5 ′ primers and a 3 ′ igg1 constant region specific primer , either 5 ′ tatgcaaggcttacaaccaca 3 ′ ( seq id no : 139 ) or 5 ′ gccagtggatagacagatgggggtgtcg 3 ′ ( seq id no : 140 ). igg2b sequences were amplified with either 5 ′ aggacaggggttgattgttga 3 ′ ( seq id no : 141 ), 5 ′ ggccagtggatagactgatgggggtgttgt 3 ′ ( seq id no : 142 ), or 5 ′ ggaggaaccagttgtatctccacaccca 3 ′ ( seq id no : 143 ). kappa chain variable regions were amplified with the above 5 ′ primers and a 3 ′ kappa constant region specific primer , either 5 ′ ctcattcctgttgaagctcttgacaat 3 ′ ( seq id no : 144 ) or 5 ′ cgactgaggcacctccagatgtt 3 ′ ( seq id no : 145 ). individual pcr products were isolated by agarose gel electrophoresis and purified using the qiaquick ® gel purification kit according to the manufacturer &# 39 ; s instructions ( qiagen ). the pcr products were subsequently cloned into the pcr ® 4blunt plasmid using the zero blunt ® topo ® pcr cloning kit according to the manufacturer &# 39 ; s instructions ( invitrogen ) and transformed into dh5 - α bacteria ( invitrogen ) through standard molecular biology techniques . plasmid dna isolated from transformed bacterial clones was sequenced using m13 forward ( 5 ′ gtaaaacgacggccagt 3 ′) ( seq id no : 146 ) and m13 reverse primers ( 5 ′ caggaaacagctatgacc 3 ′) ( seq id no : 147 ) by beckman genomics , using standard dideoxy dna sequencing methods to identify the sequence of the variable region sequences . the sequences were analyzed using vector nti software ( invitrogen ) and the imgt / v - quest software to identify and confirm variable region sequences . the nucleic acid sequences encoding and the protein sequences defining variable regions of the murine monoclonal antibodies are summarized below ( amino terminal signal peptide sequences are not shown ). cdr sequences ( kabat definition ) are shown in bold / underlined in the amino acid sequences . the amino acid sequences defining the immunoglobulin heavy chain variable regions for the antibodies produced in example 1 are aligned in fig2 . amino terminal signal peptide sequences ( for proper expression / secretion ) are not shown . cdr 1 , cdr 2 , and cdr 3 ( kabat definition ) are identified by boxes . fig3 shows an alignment of the separate cdr 1 , cdr 2 , and cdr 3 sequences for each antibody . the amino acid sequences defining the immunoglobulin light chain variable regions for the antibodies in example 1 are aligned in fig4 . amino terminal signal peptide sequences ( for proper expression / secretion ) are not shown . cdr 1 , cdr 2 and cdr 3 are identified by boxes . fig5 shows an alignment of the separate cdr 1 , cdr 2 , and cdr 3 sequences for each antibody . table 1 is a concordance chart showing the seq id no . of each sequence discussed in this example . to create the complete heavy or kappa chain antibody sequences , each variable sequence above is combined with its respective constant region . for example , a complete heavy chain comprises a heavy variable sequence followed by the murine igg1 or igg2b heavy chain constant sequence and a complete kappa chain comprises a kappa variable sequence followed by the murine kappa light chain constant sequence . the following sequences represent the actual or contemplated full length heavy and light chain sequences ( i . e ., containing both the variable and constant regions sequences ) for each antibody described in this example . signal sequences for proper secretion of the antibodies are also included at the 5 ′ end of the dna sequences or the amino terminal end of the protein sequences . the variable region sequences can be ligated to other constant region sequences , to produce active full length igg heavy and light chains . for convenience , table 4 provides a concordance chart showing the correspondence between the full length sequences of the antibodies discussed in this example with those presented in the sequence listing . the binding affinities and kinetics of the binding of monoclonal antibodies 04d01 , 09d03 , 11g01 , 12a07 , 18h02 , 22a02 and 24c05 to recombinant human erbb3 / fc fusion protein ( rherbb3 - fc ) were measured by surface plasmon resonance using a biacore ® t100 ( biacore ) instrument . rabbit anti - mouse iggs ( biacore , cat . no . br - 1008 - 38 ) were immobilized on carboxymethylated dextran cm4 sensor chips ( biacore , cat . no . br - 1005 - 34 ) by amine coupling ( biacore , cat . no . br - 1000 - 50 ) using a standard coupling protocol according to vendor &# 39 ; s instructions . the analyses were performed at 25 ° c ., using pbs ( invitrogen , cat . no . 14040 - 133 ) containing 0 . 05 % surfactant p20 ( biacore , cat . no . br - 1000 - 54 ) as running buffer . the antibodies were captured in individual flow cells at a flow rate of 10 μl / minute . injection time was varied for each antibody to yield an r max between 30 and 60 ru . buffer or rherbb3 - fc diluted in running buffer was injected sequentially over a reference surface ( no antibody captured ) and the active surface ( antibody to be tested ) for 300 seconds at 60 μl / minute . the dissociation phase was monitored for up to 3600 seconds . the surface was then regenerated with two 60 - seconds injection of 10 mm glycine - hcl , ph 1 . 7 ( made from glycine ph 1 . 5 ( biacore , cat . no . br - 1003 - 54 ) and ph 2 . 0 ( biacore , cat . no . br - 1003 - 55 )) at a flow rate of 60 μl / minute . the rherbb3 - fc concentration range tested was 0 . 125 nm to 20 nm . kinetic parameters were determined using the kinetic function of the bia evaluation software ( biacore ) with double reference subtraction . kinetic parameters for each antibody , k a ( association rate constant ), k d ( dissociation rate constant ) and k d ( equilibrium dissociation constant ) were determined . kinetic values of the monoclonal antibodies on rherbb3 - fc at 25 ° c . are summarized in table 5 . the data in table 5 demonstrate that the antibodies bind rherbb3 with a k d of about 350 pm or less , 250 pm or less , 200 pm or less , 150 pm or less , 100 pm or less , 50 pm or less , or 10 pm or less . in this example , the antibodies produced in example 1 were tested for ability to inhibit rherbb3 binding to nrg1 - β1 and nrg1 - α1 . the antibodies were tested by electrochemiluminescence ( ecl ) assay for inhibition of herbb3 binding to nrg1 - β1 . ma2400 96 - well standard binding plates ( meso scale discovery , cat . no . l15xa - 6 ) were coated with 50 μl of 0 . 5 μg / ml rherbb3 / fc ( r & amp ; d systems , cat . no . 348 - rb ) in pbs ( invitrogen , cat . no . 14040 - 133 ) for overnight at 4 ° c . with no agitation . the plates then were washed 3 times with pbs + 0 . 1 % tween20 ( sigma p5927 ) and blocked with 200 μl of pbs containing 5 % bsa ( sera care life sciences , cat . no . ap - 4510 - 80 ) for 1 . 5 hour at room temperature . after washing the plates 3 times with pbs , 25 μa of the antibody dilutions were added to the plates for another hour at room temperature with agitation . ligand nrg1 - β1 ( r & amp ; d systems , cat . no . 377 - hb , 26 kda ) was added to the wells at the final concentration of 0 . 25 μg / ml . the plates were washed three times with pbs and incubated with 25 μl of 1 μg / ml biotinylated antibody against human nrg1 - β1 ( r & amp ; d systems , cat . no baf377 ) preincubated for one hour with sulto - tag streptavidin ( meso scale discovery , cat . no r32ad - 5 ) for one hour at room temperature with agitation . the plates then were washed 3 times with pbs , and 150 μl of 1 × read buffer ( meso scale discovery , cat . no . r92tc - 1 ) was added to each well before the plates were analyzed on a sector ® imager 2400 ( meso scale discovery ) instrument . the interaction of nrg1 - β1 with erbb3 was inhibited by antibodies 04d01 , 12a07 , 18h02 , 22a02 and 24c05 ( fig6 a ). the interaction of nrg1 - β1 with rherbb3 was enhanced by antibody 09d03 , but not as well as by antibody 11g01 ( fig6 b ). the murine anti - human erbb3 antibody ic 50 values for neutralization of nrg1 - β1 binding to rherbb3 for the antibodies ( i . e ., 04d01 , 12a07 , 18h02 , 22a02 and 24c05 ) were calculated and are summarized in table 6 . the antibodies were tested by ecl assay for inhibition of herbb3 binding to the second erbb3 ligand , nrg1 - α1 . to assay inhibition of binding of nrg1 - α1 to rherbb3 , the same method used for nrg1 - β1 was used , except for the following changes : concentrations of plated rherbb3 / fc ( r & amp ; d 4518 - rb ) and of ligand nrg1 - α1 ( thermo scientific , rp - 317 - p1ax ) were 1 μg / ml and 1 . 5 μg / ml , respectively . the interaction of nrg1 - α1 with rherbb3 was inhibited by 11g01 , 12a07 , 18h02 , 22a02 , and 24c05 igg1 , and was enhanced by antibody 09d03 ( fig7 ). in this example , the antibodies produced in example 1 were tested for binding to the dimerization domain ( domain 2 ) of herbb3 - ecd . domain 2 of herbb3 ( 118 amino acids , position 210 - 327 ) was cloned in place of domain 2 of her2 ( 119 amino acids , position aa220 - 338 ) into the full - length her2 receptor . the hybrid construct her2 / 3d2 was cloned into plenti6 . 3 and packaged by transient transfection of 293t cells into a lentivirus using the virapower ™ lentiviral support kit ( invitrogen , cat . no . k497000 ). cho cells were infected with the lentivirus expressing the her2 / 3d2 hybrid protein . the binding of the anti - erbb3 hybridoma supernatants to her2 / 3d2 were tested on these engineered cho cells by ecl with sulfo - tagged anti - mouse antibodies . data on the binding of the hybridoma supernatants to the chimeric protein her2 / 3d2 expressed on the cell surface of cho cells are summarized in fig8 . these results show that antibodies 09d03 and 11g01 bound to the erbb3 domain 11 , aa210 - 327 . this example describes a characterization of the antibodies produced in example 1 for their ability to inhibit nrg1 - β1 dependent proliferation of cells . antibodies were tested in the baf / 3 cell system engineered to express both human her2 and erbb3 and in the human mcf7 breast cancer cells which naturally express both her2 and erbb3 and grow in response to nrg1 - β1 stimulation . baf / 3 cells were infected by two lentiviruses engineered to express human her2 or human erbb3 . infected cells were selected with blasticidin ( 15 μg / ml ; invitrogen , cat . no . r21001 ) and individual colonies were isolated and tested for expression of both receptors . her2 / erbb3 expressing clones were maintained in culture under blasticidin selection with [ 80 % rpmi medium 1640 ( gibco , cat . no . 11875 - 093 ), 10 % fetal bovine serum ( gibco , cat . no . 10438 - 026 ) and 10 % wehi cell conditioned media { 90 % iscove &# 39 ; s modified dulbecco &# 39 ; s medium ( gibco , cat . no . 12440053 ), 10 % fetal bovine serum ( gibco , cat . no . 10438 - 026 )+ 2 mm l - glutamine ( gibco , cat . no . 25030 - 081 )+ 0 . 0025 mm mercaptoethanol ( invitrogen , cat . no . 21985 - 023 )}]. to screen for antagonistic erbb3 antibodies , cells were rinsed with pbs , and grown in the absence of blasticidin and wehi conditioned media . assays were conducted in a 96 - well plate ( 5 , 000 cells / well ) in the presence of nrg1 - β1 ( 100 ng / ml ) and various concentrations of antibodies ( 0 . 018 - 5000 ng / ml in 100 μl final volume ). mtt ( 3 -( 4 , 5 - dimethylthiazol - 2 - yl )- 2 , 5 - diphenyltetrazolium bromide ) assays were conducted 3 - 4 days post nrg1 - β1 stimulation . an example of the dose - dependent inhibition of nrg1 - β1 dependent cell proliferation of her2 / erbb3 - baf / 3 by murine anti - human erbb3 antibodies is shown in fig9 . inhibition data of nrg1 - β1 dependent her2 / erbb3 - baf / 3 cell line proliferation with monoclonal antibodies ( i . e ., 04d01 , 09d03 , 11g01 , 12a07 , 18h02 , 22a02 and 24c05 ) are summarized in table 7 . mcf7 cells ( atcc , cat . no . htb - 22 ) were maintained as recommended by atcc . cells were plated at 5 , 000 cells / well in a 96 - well plate . cells were starved overnight in the absence of serum . the following day , nrg1 - β1 ( 40 ng / ml ) and various concentrations of antibodies ( 12 . 8 pg / ml - 20 μg / ml in 100 μl final volume ) were added to the cells . mtt ( 3 -( 4 , 5 - dimethylthiazol - 2 - yl )- 2 , 5 - diphenyltetrazolium bromide ) assays were conducted three days post nrg1 - β1 stimulation . an example of the dose - dependent inhibition of nrg1 - β1 dependent proliferation of mcf7 cells by murine anti - human erbb3 antibodies is shown in fig1 . inhibition data of nrg1 - β1 dependent mcf7 cell proliferation with antibodies 04d01 , 09d03 , 11g01 , 12a07 , 18h02 , 22a02 and 24c05 are summarized in table 8 . the antibodies produced in example 1 were also tested for their ability to inhibit proliferation of erbb3 expressing human cancer cells . breast cancer cells skbr - 3 overexpress her2 and are sensitive to her2 - specific inhibitory antibodies . skbr - 3 cells ( atcc , cat . no . htb - 30 ) were maintained as recommended by atcc . cells were plated at 5 , 000 cells / well in a 96 - well plate in the presence of 5 μg / ml of antibodies but without exogenous nrg1 - β1 . mtt ( 3 -( 4 , 5 - dimethylthiazol - 2 - yl )- 2 , 5 - diphenyltetrazolium bromide ) assays were conducted after three days in culture . an example of inhibition of cell proliferation of skbr - 3 cells by murine anti - human erbb3 antibodies is shown in fig1 . the results in fig1 show that antibodies 04d01 , 09d03 , 11g01 , 12a07 , 18h02 , 22a02 and 24c05 inhibited proliferation of skbr - 3 cells . this example describes a characterization of the antibodies produced in example 1 for their ability to inhibit nrg1 - β1 dependent phosphorylation of erbb3 and the downstream kinase akt , as the readout for pi3k activation . these antibodies were also tested for their ability to inhibit steady state phosphorylation of erbb3 and akt in exponentially growing cells . breast cancer cells skbr - 3 and mcf7 and prostate cancer cells du145 were maintained as recommended by atcc . cells were starved overnight in 0 % fbs , treated for one hour with 5 μg / ml of antibody followed by nrg1 - β1 stimulation . lysates were either analyzed by elisa with the phospho - erbb3 kit from r & amp ; d systems ( cat . no dyc1769 ) or with the phospho - akt elisa kit from cell signaling ( cat . no 7143 ). an example of the inhibition of the nrg1 - β1 induced phosphorylation of erbb3 in skbr - 3 cells by murine anti - human erbb3 antibodies is shown in fig1 . the results in fig1 demonstrated that antibodies 04d01 , 09d03 , 11g01 , 12a07 , 18h02 , 22a02 and 24c05 inhibited at least 50 % of the phosphorylation of erbb3 induced by nrg1 - β1 in skbr - 3 cells . an example of the inhibition of the nrg1 - β1 induced phosphorylation of akt in mcf7 and du145 cells by murine anti - human erbb3 antibodies is shown in fig1 a and fig1 b , respectively . the results in fig1 a and 13b demonstrated that antibodies 04d01 , 09d03 , 11g01 , 12a07 , 18h02 , 22a02 and 24c05 inhibited at least 80 % of the phosphorylation of akt in response to the nrg1 - β1 in both mcf7 and du145 cells . the capacity of the anti - erbb3 antibodies to inhibit the steady state phosphorylation status of erbb3 and akt in a breast cancer cell line skbr - 3 and a pancreatic cancer cell line bxpc3 were tested by treating these exponentially growing cells for one hour in presence of antibodies at 5 μg / ml . western blot analysis of these experiments demonstrated that antibodies 04d01 , 09d03 , 11g01 , 12a07 , 18h02 , 22a02 and 24c05 inhibited the steady state level of phosphorylation of akt and erbb3 in both skbr - 3 and bxpc3 cells . in this example , the antibodies produced in example 1 were tested for their ability to inhibit nrg1 - β1 dependent phosphorylation of egfr in the ovarian cancer cell line nci / adr - res . nci / adr - res cells ( dtp / dctd nci tumor repository ) were starved overnight in 0 % fbs , pre - treated with antibody ( 5 μg / ml ) for one hour followed by nrg1 - β1 ( 20 ng / ml ) stimulation for 15 minutes . the phosphorylation of egfr on tyrosine 1068 was analyzed by western blot . the results of this experiment demonstrated that antibodies 04d01 , 09d03 , 11g01 , 12a07 , 18h02 , 22a02 and 24c05 inhibited the phosphorylation of egfr in response to the nrg1 - β1 in nci / adr - res cells . in this example , the antibodies produced in example 1 were tested for their ability to inhibit egf dependent phosphorylation of erbb3 in the egfr overexpressing , epidermoid cancer cell line a431 . a431 cells ( atcc , cat . no crl - 1555 ) were starved overnight in 0 % fbs , pre - treated with antibody ( 5 μg / ml ) for one hour followed by egf ( r & amp ; d systems , cat . no . 236 - eg ) ( 50 ng / ml ) stimulation for 15 minutes . the phosphorylation of erbb3 was analyzed by western blot . the results of this experiment demonstrated that antibodies 04d01 , 09d03 , 12a07 , 18h02 , 22a02 and 24c05 inhibited to various extents the phosphorylation of erbb3 in response to the egf in a431 cells . this example describes a characterization of the antibodies produced in example 1 for their ability to inhibit the formation of the her2 / erbb3 dimer in response to nrg1 - β1 in skbr - 3 cells . breast cancer cells skbr - 3 were starved overnight in 0 % fbs , treated for one hour with 5 μg / ml of antibody followed by nrg1 - β1 stimulation ( 30 ng / ml , 30 min ). lysates were immunoprecipitated with anti - her2 antibody ( r & amp ; d systems , cat . no . baf1129 ) and analyzed by western blot with polyclonal anti - erbb3 antibody ( santa cruz , cat . no . sc285 ). the results of this experiment demonstrated that antibodies 04d01 , 09d03 , 11g01 , 12a07 , 18h02 , 22a02 and 24c05 inhibited nrg1 - β1 - induced her2 / erbb3 dimer formation in skbr - 3 cells . the ability of murine monoclonal antibodies produced in example 1 to inhibit tumor growth was tested in a pancreatic bxpc3 xenograft model . human pancreatic bxpc3 cells were grown in culture in 37 ° c . in an atmosphere containing 5 % co2 , using rmpi medium containing 10 % fetal bovine serum . bxpc3 cells were inoculated subcutaneously into the flank of 8 - week old female cb . 17 scid mice ( taconic labs ) with 10 × 10 6 cells per mouse in 50 % matrigel ( bd biosciences , cat no . 356237 ). tumor measurements were taken twice weekly using vernier calipers . tumor volume was calculated using the formula : width × width × length / 2 . when tumors reached approximately 200 mm 3 , the mice were randomized into 9 groups of 10 mice each . one group received pbs and another received human igg control ( huigg ). each of the other eight groups received one of the antibody , 04d01 , 09d03 , 18h02 , 11g01 , 24c05 , 22a02 , or 12a07 . all antibodies were dosed at 20 mg / kg body weight , twice per week , by intra - peritoneal injection for 6 weeks . tumor volumes and mouse body weights were recorded twice per week . tumor growth inhibition was analyzed using anova and is expressed as percent inhibition compared to the pbs control . the results in fig1 show that antibody 24c05 inhibited tumor growth by 76 % in this model ( p & lt ; 0 . 001 ). antibodies 04d01 , 18h02 and 11g01 also inhibited tumor growth in this model at 64 %, 71 %, and 72 %, respectively ( p & lt ; 0 . 001 ). antibodies 12a07 and 22a02 demonstrated the least activity , i . e ., near 40 % tumor growth inhibition , while antibody 09d03 gave 60 % tumor growth inhibition in this model . this example describes the humanization of the murine antibody designated 24c05 , and the characterization of the resulting humanized antibodies . the humanized anti - erbb3 antibodies were designed using the superhumanization ™ method ( arana therapeutics ltd . and hwang , w . y . et al . ( 2005 ) methods 36 : 35 - 42 ) or the cdr grafting method with back mutations ( some human framework residues were changed to murine residues ) ( see e . g ., u . s . pat . nos . 5 , 530 , 101 ; 5 , 693 , 761 ; 5 , 693 , 762 ; 5 , 585 , 089 ; 6 , 180 , 370 ; 7 , 022 , 500 ). with the exception of heavy chain cdr1 , the kabat cdr definitions were used for cdr grafting onto human frameworks . a combination of kabat and chothia definitions were used for grafting heavy cdr1 . the designed amino acid sequences were converted to codon - optimized dna sequences and synthesized by dna2 . 0 , inc . to include ( in the following order ): 5 ′ hindiii restriction site , kozak consensus sequence , amino terminal signal sequence , humanized variable region , human igg1 or kappa constant region , stop codon , and a 3 ′ ecori restriction site . additionally , one humanized heavy chain , sh24c05 hv3 - 11 heavy igg1 , was mutated using overlap extension pcr to enhance humanization , resulting in the sh24c05 hv3 - 11 n62s heavy chain igg1 . a human igg2 version of the sh24c05 hv3 - 11 n62s heavy chain was also constructed . the anti - erbb3 antibody chains humanized according to the superhumanization ™ method , as described herein , are designated with the prefix “ sh ” before the antibody chain name . the anti - erbb3 antibody chains humanized by the cdr grafting method with back mutations , as described herein , are designated with the prefix “ hu ” before the antibody chain name . chimeric ( murine variable region and human constant region ) 24c05 heavy ( human igg1 ) and light ( human kappa ) chains were also constructed . the murine variable regions were fused to the human constant region using overlap extension pcr , including ( in the following order ): 5 ′ hindiii restriction site , kozak consensus sequence , amino terminal signal sequence , mouse variable region , human igg1 or kappa constant region , stop codon , and 3 ′ ecori restriction site . the humanized and chimeric heavy chains were subcloned into pee6 . 4 ( lonza biologics ) via hindiii and ecori sites using in - fusion ™ pcr cloning ( clontech ). the humanized and chimeric kappa light chains were subcloned into pee14 . 4 ( lonza biologics ) via hindiii and ecori sites using in - fusion ™ pcr cloning . humanized antibody chains or chimeric antibody chains were transiently transfected into 293t cells to produce antibody . antibody was either purified or used in cell culture media supernatant for subsequent in vitro analysis . binding of the chimeric and humanized antibodies to human erbb3 was measured as described below . the results are summarized in table 15 . additionally , some humanized antibody heavy and light chain combinations were stably expressed in chok1 sv cells using the gs system ™ ( lonza biologics ) in order to produce large quantities of purified humanized antibody . a single expression vector was constructed by combining pee6 . 4 and pee14 . 4 based vectors . first , pee6 . 4 containing full length humanized heavy chain cdna was digested with noti and sali to isolate the hcmv - mie promoter + full length humanized heavy chain cdna + sv40 polya fragment . this fragment was inserted into the pee14 . 4 vector already containing full length humanized light chain cdna via noti / sali sites , thus creating an expression vector that simultaneously expresses heavy and light chains . the combined heavy and light chain vector was linearized and transfected into chok1sv cells . stable clones were selected in the presence of methionine sulfoximine . each of the possible combinations of the humanized immunoglobulin heavy chain and immunoglobulin light chain variable regions are set forth below in table 9 . the nucleic acid sequences encoding and the protein sequences defining variable regions of the humanized 24c05 antibodies are summarized below ( amino terminal signal peptide sequences are not shown ). cdr sequences ( kabat definition ) are shown in bold and are underlined in the amino acid sequences . the amino acid sequences defining the immunoglobulin heavy chain variable regions for the antibodies produced in example 12 are aligned in fig1 . amino terminal signal peptide sequences ( for proper expression / secretion ) are not shown . cdr 1 , cdr 2 , and cdr 3 ( kabat definition ) are identified by boxes . the amino acid sequences defining the immunoglobulin light chain variable regions for the antibodies in example 12 are aligned in fig1 . amino terminal signal peptide sequences ( for proper expression / secretion ) are not shown . cdr 1 , cdr 2 and cdr 3 are identified by boxes . table 10 is a concordance chart showing the seq id no . of each sequence discussed in this example . to create the complete chimeric and humanized heavy or kappa chain antibody sequences , each variable sequence above is combined with its respective human constant region . for example , a complete heavy chain comprises a heavy variable sequence followed by a human igg1 heavy chain constant sequence or a human igg2 heavy chain constant sequence . a complete kappa chain comprises a kappa variable sequence followed by the human kappa light chain constant sequence . the following sequences represent the actual or contemplated full length heavy and light chain sequences ( i . e ., containing both the variable and constant regions sequences ) for each antibody described in this example . signal sequences for proper secretion of the antibodies are also included at the 5 ′ end of the dna sequences or the amino terminal end of the protein sequences . it is also contemplated herein that the variable region sequences can be ligated to other constant region sequences to produce active full length igg heavy and light chains . for convenience , table 13 provides a concordance chart showing the seq id no . of each sequence discussed in this example . table 14 below shows antibodies containing chimeric immunoglobulin heavy and light chains and each of the possible combinations of the full - length humanized immunoglobulin heavy and light chains . chimeric 24c05 = full length chimeric 24c05 heavy chain ( mouse variable region and human igg1 constant region ) ( seq id no : 182 ) plus full length chimeric 24c05 light chain ( mouse variable region and human kappa constant region ) ( seq id no : 184 ) four of the possible antibody constructs containing the full length immunoglobulin heavy and light chains containing humanized variable regions are designated below : sh24c05 - 25 n62s igg1 = humanized sh24c05 hv3 - 11 n62s heavy chain variable region and human igg1 constant region ( seq id no : 190 ) plus sh24c05 kv1 - 16 light chain variable region and human kappa constant region ( seq id no : 204 ) sh24c05 - 25 n62s igg2 = humanized sh24c05 hv3 - 11 n62s heavy chain variable region and human igg2 constant region ( seq id no : 192 ) plus sh24c05 kv1 - 16 light chain variable region and human kappa constant region ( seq id no : 204 ) sh24c05 - 31 n62s igg1 = humanized sh24c05 hv3 - 11 n62s heavy chain variable region and human igg1 constant region ( seq id no : 190 ) plus sh24c05 kv1 - 17 light chain variable region and human kappa constant region ( seq id no : 206 ) sh24c05 - 31 n62s igg2 = humanized sh24c05 hv3 - 11 n62s heavy chain variable region and human igg2 constant region ( seq id no : 192 ) plus sh24c05 kv1 - 17 light chain variable region and human kappa constant region ( seq id no : 206 ) the binding affinities and kinetics of interaction of monoclonal antibodies produced in example 12 against recombinant human erbb3 monomeric protein ( cleaved rherbb3 ) were measured by surface plasmon resonance using a biacore ® t100 ( biacore ) instrument . monomeric erbb3 was obtained by protease cleavage of rherbb3 - fc ( r & amp ; d systems , cat . no . 348 - rb ). goat anti - human igg fc ( jackson immunoresearch , catalog no . 109 - 005 - 098 ) was immobilized on carboxymethylated dextran cm4 sensor chips ( biacore , catalog no . br - 1005 - 34 ) by amine coupling ( biacore , catalog no . br - 1000 - 50 ) using a standard coupling protocol according to the vendor &# 39 ; s instructions . the analyses were performed at 37 ° c . using pbs ( invitrogen , catalog no . 14040 - 133 ) containing 0 . 05 % surfactant p20 ( biacore , catalog no . br - 1000 - 54 ) as running buffer . the antibodies were captured in individual flow cells at a flow rate of 60 μl / minute . injection time was varied for each antibody to yield an r max between 30 and 60 ru . buffer or cleaved rherbb3 diluted in running buffer was injected sequentially over a reference surface ( no antibody captured ) and the active surface ( antibody to be tested ) for 300 seconds at 60 μl / minute . the dissociation phase was monitored for up to 1200 seconds . the surface was then regenerated with two 60 second injections of glycine ph 2 . 25 ( made from glycine ph 2 . 0 ( biacore , catalog no . br - 1003 - 55 ) and ph 2 . 5 ( biacore , catalog no . br - 1003 - 56 )) at 60 μl / minute . for the initial screening , only one or two concentrations of cleaved rherbb3 were tested , typically 5 . 0 and 1 . 25 nm ( results are summarized in table 15 ). kinetic parameters were determined using the kinetic function of the biaevaluation software ( biacore ) with double reference subtraction . kinetic parameters for each antibody , k a ( association rate constant ), k d ( dissociation rate constant ) and k d ( equilibrium dissociation constant ) were determined . the initial monoclonal antibodies were screened using cell culture media supernatant containing secreted antibody , and kinetic values of the monoclonal antibodies on cleaved rherbb3 at 37 ° c . are summarized in table 15 . the results in table 15 demonstrate that the chimeric and each of the humanized 24c05 antibodies have fast association rates ( k a ), very slow disassociation rates ( k d ) and very high affinities ( k d ). in particular , the antibodies have affinities ranging from about 87 pm to about 1 nm . the binding affinities and kinetics of certain purified monoclonal antibodies were also determined . to further characterize certain antibodies , the surface plasmon resonance experiments described above were conducted using concentrations of cleaved rherbb3 between 0 . 3125 nm and 5 . 0 nm ( a 2 - fold serial dilution ). the kinetic values of certain purified monoclonal antibodies ( i . e ., sh24c05 - 1 , sh24c05 - 25 , sh24c05 - 25 n62s igg1 , sh24c05 - 25 n62s igg2 , sh24c05 - 31 , sh24c05 - 31 n62s igg1 , and sh24c05 - 31 n62s igg2 ) on cleaved rherbb3 at 37 ° c . are summarized in table 16 . three human antibodies that inhibit the function of human erbb3 were constructed and expressed using published information . one antibody , referred to as ab # 6 , was constructed as a human igg2 / lambda antibody based the disclosure of schoeberl et al ., us 2009 / 0291085 ( merrimack pharmaceuticals , inc .). two additional antibodies , referred to as u1 - 53 and u1 - 59 , were constructed as human igg1 / kappa antibodies based on the disclosure of rothe et al ., us 2008 / 0124345 ( u3 pharma ag and amgen , inc .). kinetic parameters for the ab # 6 , u1 - 53 , and u1 - 59 antibodies were determined by biacore at 37 ° c . using cleaved rherbb3 ( monomer ) as described above ( see section b . binding affinities of humanized and chimeric anti - erbb3 monoclonal antibodies ). both biacore sensorgrams ( fig1 ) and kinetic values ( table 17 ) are displayed for each antibody . the results in table 17 demonstrate that the overall equilibrium dissociation constant ( k d ) for the sh24c05 - 31 n62s igg1 ( 76 pm ) was smaller ( i . e ., higher affinity ) than the k d for the ab # 6 and u1 - 59 antibodies ( 230 pm ( p & lt ; 0 . 01 ) and 530 pm ( p & lt ; 0 . 0005 ), respectively ). the equilibrium dissociation constant ( k d ) for u1 - 53 could not determined because of poor curve fits ( see fig1 , which shows a fast k off rate of u1 - 53 ). the k d of ab # 6 , u1 - 53 , and u1 - 59 antibodies can also be compared with other humanized 24c05 variants by comparing tables 16 and 17 . therefore , the affinity for sh24c05 - 31 n62s igg1 is significantly higher than the affinity of ab # 6 and u1 - 59 as disclosed herein . in this example , the humanized antibodies produced in example 12 were tested for their ability to inhibit rherbb3 binding to nrg1 - β1 by ecl assay . multi - array 96 - well standard binding plates ( meso scale discovery , cat . no . l15xa - 3 ) were coated with 50 μl of 0 . 5 μg / ml rherbb3 / fc ( r & amp ; d systems , cat . no . 348 - rb ) in pbs ( invitrogen , cat . no . 14040 - 133 ) for one hour at room temperature with no agitation . the plates then were washed three times with pbs + 0 . 1 % tween20 ( sigma p5927 ) and blocked with 200 μl of 100 % horse serum , heat inactivated ( gibco , cat . no . 26050 - 088 ) for 1 . 5 hours at room temperature . after washing the plates three times with pbs + 0 . 1 % tween , 25 μl of the antibody dilutions were added to the plates for another hour at room temperature with agitation . ligand nrg1 - β1 ( r & amp ; d systems , cat . no . 377 - hb , 26 kda ) was added to the wells at a final concentration of 0 . 25 μg / ml . the plates were washed three times with pbs + 0 . 1 % tween and incubated with 25 μl of 1 μg / ml biotinylated antibody against human nrg1 - β1 ( r & amp ; d systems , cat . no baf377 ) preincubated for one hour with sulto - tag streptavidin ( meso scale discovery , cat . no r32ad - 5 ) for one hour at room temperature with agitation . the plates then were washed three times with pbs + 0 . 1 % tween , and 150 μl of 1 × read buffer ( meso scale discovery , cat . no . r92tc - 1 ) was added to each well before the plates were analyzed on a sector ® imager 2400 ( meso scale discovery ) instrument . the interaction of nrg1 - β1 with rherbb3 was inhibited by antibodies sh24c05 - 25 n62s - igg1 , sh24c05 - 25 n62s - igg2 , sh24c05 - 31 n62s - igg1 , and sh24c05 - 31 n62s - igg2 ( fig1 a ). the ab # 6 igg2 antibody as described in schoeberl et al . ( supra ) and the u1 - 53 and u1 - 59 antibodies as described in rothe et al . ( supra ) were also tested for their ability to inhibit erbb3 binding to nrg1 - β1 . as shown in fig1 b , each of the ab # 6 igg2 , u1 - 53 , and u1 - 59 antibodies inhibited erbb3 binding to nrg1 - β1 . the ic 50 values for neutralization of nrg1 - β1 binding to herbb3 for the humanized 24c05 antibodies ( i . e ., sh24c05 - 25 n62s - igg1 , sh24c05 - 25 n62s - igg2 , sh24c05 - 31 n62s - igg1 , and sh24c05 - 31 n62s - igg2 ) were calculated and are summarized in table 18 . the ic 50 values for the nrg1 - β1 neutralization activity of the anti - erbb3 human antibodies ab # 6 igg2 , u1 - 53 and u1 - 59 are also shown in table 18 . the results in table 18 demonstrate that antibodies sh24c05 - 25 n62s - igg1 , sh24c05 - 25 n62s - igg2 , sh24c05 - 31 n62s - igg1 , and sh24c05 - 31 n62s - igg2 efficiently neutralized nrg1 - β1 binding to rherbb3 . while the anti - erbb3 human antibodies ab # 6 igg2 , u1 - 53 and u1 - 59 also showed neutralization activity , the humanized sh24c05 antibodies ( i . e ., sh24c05 - 25 n62s - igg1 , sh24c05 - 25 n62s - igg2 , sh24c05 - 31 n62s - igg1 , and sh24c05 - 31 n62s - igg2 ) had superior neutralization capacity than u1 - 59 or ab # 6 igg2 . in this example , the humanized antibodies produced in example 12 were tested for their ability to inhibit nrg1 - β1 dependent proliferation of cells in the baf / 3 cell system engineered to express both human her2 and erbb3 . baf / 3 cells expressing her2 and erbb3 receptors as described in example 6 were treated with anti - erbb3 antibodies in the absence of wehi conditioned media but in the presence of nrg1 - β1 ( 100 ng / ml ). assays were conducted in a 96 - well plate ( 5 , 000 cells / well ) in the presence of nrg1 - β1 ( 100 ng / ml ) and various concentrations of antibodies ( 0 . 018 - 5000 ng / ml in 100 μl of final volume ). mtt ( 3 -( 4 , 5 - dimethylthiazol - 2 - yl )- 2 , 5 - diphenyltetrazolium bromide ) assays were conducted 3 - 4 days post nrg1 - β1 stimulation . the results demonstrate that sh24c05 - 25 n62s - igg1 , sh24c05 - 25 n62s - igg2 , sh24c05 - 31 n62s - igg1 , and sh24c05 - 31 n62s - igg2 inhibited nrg induced her2 / erbb3 - baf / 3 cell proliferation in a dose dependent manner ( fig1 a ). the ic 50 values for the inhibition of nrg1 - β1 dependent her2 / erbb3 - baf / 3 cell line proliferation with the humanized 24c05 antibodies ( i . e ., sh24c05 - 25 n62s - igg1 , sh24c05 - 25 n62s - igg2 , sh24c05 - 31 n62s - igg1 , sh24c05 - 31 n62s - igg2 ) were calculated and are summarized in table 19 . the inhibitory activity of anti - erbb3 ab # 6 igg2 , u1 - 53 and u1 - 59 antibodies were also tested in the nrg1 - β1 dependent her2 / erbb3 - baf / 3 cells proliferation assay . as shown in fig1 b , the results demonstrate that the ab # 6 igg2 , u1 - 53 and u1 - 59 antibodies inhibited nrg induced her2 / erbb3 - baf / 3 cell proliferation in a dose dependent manner . inhibition data of nrg1 - β1 dependent her2 / erbb3 - baf / 3 cell proliferation with antibodies ab # 6 igg2 , u1 - 53 and u1 - 59 are summarized in table 19 . the results in table 19 demonstrate that antibodies ab # 6 igg2 , u1 - 53 , and u1 - 59 inhibited nrg1 - β1 - induced proliferation of her2 / erbb3 - baf / 3 cells . a comparison of the inhibitory activity of the tested anti - erbb3 antibodies in the nrg1 - β1 dependent her2 / erbb3 - baf / 3 cells proliferation assay indicates that the inhibitory activity of the humanized sh24c05 antibodies is superior to the inhibitory activity of the ab # 6 igg2 , u1 - 53 and u1 - 59 antibodies ( e . g ., the ic 50 was 0 . 1245 nm for sh24c05 - 31 n62s - igg1 compared to 0 . 8128 nm for u1 - 53 ). this example describes a characterization of the humanized antibodies produced in example 12 for their ability to degrade total erbb3 and inhibit phosphorylation of erbb3 in exponentially growing skbr - 3 cells . the breast cancer skbr - 3 cells were maintained as recommended by atcc . cells maintained in full serum condition were treated for 1 , 2 , 4 or 6 hours with 40 μg / ml of anti - erbb3 antibody ( i . e ., sh24c05 - 25 n62s - igg1 , sh24c05 - 25 n62s - igg2 , sh24c05 - 31 n62s - igg1 , and sh24c05 - 31 n62s - igg2 ). lysates were either analyzed by elisa with the total - erbb3 and the phospho - erbb3 kit from r & amp ; d systems ( cat . no dyc234 and cat . no dyc1769 , respectively ). the results demonstrate that anti - erbb3 antibodies sh24c05 - 25 n62s - igg1 , sh24c05 - 25 n62s - igg2 , sh24c05 - 31 n62s - igg1 , and sh24c05 - 31 n62s - igg2 inhibit at least 50 % of the phosphorylation of erbb3 in exponentially growing skbr - 3 cells ( fig2 ). the results also demonstrate that anti - erbb3 antibodies sh24c05 - 25 n62s - igg1 , sh24c05 - 25 n62s - igg2 , sh24c05 - 31 n62s - igg1 , and sh24c05 - 31 n62s - igg2 degraded at least 50 % of the total erbb3 receptor present in exponentially growing skbr - 3 cells ( fig2 ). the ability of the humanized monoclonal antibodies produced in example 12 to inhibit tumor growth were tested in a bxpc3 pancreatic xenograft model . human pancreatic bxpc3 cells were grown in culture in 37 ° c . in an atmosphere containing 5 % co2 , using rmpi medium containing 10 % fetal bovine serum . bxpc3 cells were inoculated subcutaneously into the flank of 8 - week old female cb . 17 scid mice ( taconic labs ) with 10 × 10 6 cells per mouse in 50 % matrigel ( bd biosciences , cat no . 356237 ). tumor measurements were taken twice weekly using vernier calipers . tumor volume was calculated using the formula : width × width × length / 2 . when tumors reached approximately 200 mm 3 , the mice were randomized into 8 groups of 10 mice each . one group received pbs , another received huigg control , and another received muigg control . each of the remaining five groups received one of the antibodies ( i . e ., murine 24c05 , sh24c05 - 25 n62s - igg1 , sh24c05 - 25 n62s - igg2 , sh24c05 - 31 n62s - igg1 or sh24c05 - 31 n62s - igg2 ). all of the antibodies were dosed at 2 mg / kg body weight , twice per week , by intra - peritoneal injection for 7 weeks . tumor volumes and mouse body weights were recorded twice per week . tumor growth inhibition was analyzed using anova and is expressed as percent inhibition compared to the pbs control . the tested humanized antibodies were active in vivo . all four humanized anti - erbb3 antibodies had similar efficacy in the bxpc3 model when dosed at 2 mg / kg , ranging from 75 - 80 % tumor growth inhibition ( p & lt ; 0 . 001 ) ( i . e ., sh24c05 - 25 n62s - igg1 , 75 %; sh24c05 - 25 n62s - igg2 , 76 %; sh24c05 - 31 n62s - igg1 , 79 %; and sh24c05 - 31 n62s - igg2 , 80 %) at day 28 of the study ( fig2 ). the murine antibody demonstrated 65 % tumor growth inhibition in this study ( p & lt ; 0 . 05 ). these results suggest similar potency and activity of the four humanized antibodies in this model . the ability of the humanized monoclonal antibodies u1 - 53 , u1 - 59 , and ab # 6 igg2 to inhibit tumor growth were also tested in a bxpc3 xenograft model . using the protocol described above , bxpc3 tumors were generated in cb . 17 scid mice . when tumors reached approximately 200 mm 3 , the mice were randomized into 11 groups of 10 mice each . one group received pbs and another received huigg control . each of the other nine groups received one of the humanized antibodies ( i . e ., sh24c05 - 31 n62s - igg1 , u1 - 53 , u1 - 59 , or ab # 6 igg2 ). the antibodies were dosed either at 0 . 5 mg / kg , 1 mg / kg , or 5 mg / kg body weight , twice per week , by intra - peritoneal injection for 7 weeks . tumor volumes and mouse body weights were recorded twice per week . tumor growth inhibition was analyzed using anova and is expressed as percent inhibition compared to the pbs control . tumor growth inhibition data determined at day 29 following treatment with one of the humanized antibodies ( i . e ., sh24c05 - 31 n62s - igg1 , u1 - 59 , or ab # 6 igg2 ) is shown in table 20 . the results demonstrate that sh24c05 - 31 n62s - igg1 showed the greatest tumor growth inhibition by day 29 ( 76 . 5 %, p & lt ; 0 . 001 ) at a dose of 5 mg / kg in the bxpc3 pancreatic xenograft model . the u1 - 59 and ab # 6 igg2 antibodies demonstrated approximately 60 % and 41 % tumor growth inhibition at a dose of 5 mg / kg in the bxpc3 model , respectively ( p & lt ; 0 . 001 ). the results also demonstrate that sh24c05 - 31 n62s - igg1 showed the greatest tumor growth inhibition by day 29 at a dose of 0 . 5 mg / kg ( 63 . 3 %, p & lt ; 0 . 001 ) and at a dose of 1 mg / kg ( 75 . 0 %, p & lt ; 0 . 001 ) in the bxpc3 pancreatic xenograft model . the u1 - 59 and ab # 6 igg2 antibodies demonstrate approximately 33 % ( p & lt ; 0 . 01 ) and 31 % ( p & lt ; 0 . 05 ) tumor growth inhibition at a dose of 0 . 5 mg / kg in the bxpc3 model , respectively . the u1 - 59 and ab # 6 igg2 antibodies demonstrated approximately 53 % ( p & lt ; 0 . 001 ) and 2 % ( not significant ) tumor growth inhibition at a dose of 1 . 0 mg / kg in the bxpc3 model , respectively . the ability of the humanized monoclonal antibodies produced in example 12 to inhibit tumor growth was tested in a calu - 3 non - small cell lung cancer xenograft model . the ability of the humanized monoclonal antibodies u1 - 59 and ab # 6 igg2 , as described in example 12 , to inhibit tumor growth were also tested in the same model . human non - small cell lung cancer calu - 3 cells were grown in culture in 37 ° c . in an atmosphere containing 5 % co2 , using emem medium containing 10 % fetal bovine serum . calu - 3 cells were inoculated subcutaneously into the flank of 8 - week old female ncr nude mice ( taconic labs ) with 10 × 10 6 cells per mouse in 50 % matrigel ( bd biosciences , cat no . 356237 ). tumor measurements were taken twice weekly using vernier calipers . tumor volume was calculated using the formula : width × width × length / 2 . when tumors reached approximately 200 mm 3 , the mice were randomized into 11 groups of 10 mice each . one group received pbs and another received muigg control . each of the other nine groups received one of the humanized antibodies ( i . e ., sh24c05 - 31 n62s - igg1 , u1 - 59 , or ab # 6 igg2 ) at a dose of either 5 mg / kg , 10 mg / kg or 20 mg / kg body weight , twice per week , by intra - peritoneal injection for 4 weeks . tumor volumes and mouse body weights were recorded twice per week . tumor growth inhibition was analyzed using anova and is expressed as percent inhibition compared to the pbs control . tumor growth inhibition data determined at day 26 following treatment with one of the humanized antibodies ( i . e ., sh24c05 - 31 n62s - igg1 , u1 - 59 , or ab # 6 igg2 ) is shown in table 21 . the results using the calu - 3 non - small cell lung cancer xenograft model demonstrate that sh24c05 - 31 n62s - igg1 showed the greatest tumor growth inhibition by day 26 at all doses tested ( i . e ., 5 mg / kg , 10 mg / kg , and 20 mg / kg of body weight ). for example , at the 10 mg / kg dose , sh24c05 - 31 n62s - igg1 showed the greatest tumor growth inhibition by day 26 ( 62 %, p & lt ; 0 . 001 ) when compared to ab # 6 igg2 ( 36 %, ns ) or u1 - 59 ( 57 %, p & lt ; 0 . 001 ). at the 20 mg / kg dose , sh24c05 - 31 n62s - igg1 also showed the greatest tumor growth inhibition by day 26 ( 69 %, p & lt ; 0 . 001 ) when compared to ab # 6 igg2 ( 48 %, p & lt ; 0 . 001 ) or u1 - 59 ( 58 %, p & lt ; 0 . 001 ). the ability of the humanized monoclonal antibodies produced in example 12 to inhibit tumor growth were tested in a mda - mb - 453 breast xenograft model ( which is a her2 positive breast model ). the ability of the humanized monoclonal antibodies u1 - 59 and ab # 6 igg2 , as described in example 12 , to inhibit tumor growth were also tested in the same model . human breast mda - mb - 453 cells were grown in culture in 37 ° c . in an atmosphere containing 0 % co2 , using leibovitz atcc medium ( cat no . 30 - 2008 ) containing 10 % fetal bovine serum . mda - mb - 453 cells were inoculated subcutaneously into the flank of 8 - week old female nod scid mice ( taconic labs ) with 20 × 10 6 cells per mouse in 50 % matrigel ( bd biosciences , cat no . 356237 ). tumor measurements were taken twice weekly using vernier calipers . tumor volume was calculated using the formula : width × width × length / 2 . when tumors reached approximately 200 mm 3 , the mice were randomized into 7 groups of 10 mice each . one group received pbs and another received huigg control . each of the other nine groups received one of the humanized antibodies ( i . e ., sh24c05 - 31 n62s - igg1 , u1 - 59 , or ab # 6 igg2 ). sh24c05 - 31 n62s - igg1 was dosed either at 5 mg / kg , 10 mg / kg , or 20 mg / kg body weight , twice per week , by intra - peritoneal injection for more than 10 weeks ; u1 - 59 , or ab # 6 were dosed at 10 mg / kg with the same frequency . tumor volumes and mouse body weights were recorded twice per week . tumor growth inhibition was analyzed using anova and is expressed as percent inhibition compared to the pbs control . tumor growth inhibition data determined at day 71 following treatment with one of the humanized antibodies ( i . e ., sh24c05 - 31 n62s - igg1 , u1 - 59 , or ab # 6 igg2 ) is shown in table 22 . the results using the mda - mb - 453 xenograft model demonstrate that sh24c05 - 31 n62s - igg1 showed potent tumor growth inhibition by day 71 at all doses tested ( i . e ., 5 mg / kg , 10 mg / kg , and 20 mg / kg of body weight ). the results also demonstrate that at the 10 mg / kg dose , sh24c05 - 31 n62s - igg1 showed greater tumor growth inhibition by day 71 ( 84 %, p & lt ; 0 . 001 ) when compared to ab # 6 igg2 ( 62 %, p & lt ; 0 . 001 ). sh24c05 - 31 n62s - igg1 showed equivalent tumor growth inhibition as u1 - 59 at the same dose . the entire disclosure of each of the patent documents and scientific articles referred to herein is incorporated by reference for all purposes . the invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof . the foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting on the invention described herein . scope of the invention is thus indicated by the appended claims rather than by the foregoing description , and all changes that come within the meaning and the range of equivalency of the claims are intended to be embraced therein .

US-201313919582-A

a self propelled upright vacuum cleaner is provided that has at least one drive wheel , a transmission for selectively driving the drive wheel in forward and reverse and propelling the cleaner in forward and reverse over a floor . a bag housing pivotally connected to the floor engaging portion . an electric power switch located adjacent to a top of the bag housing . a control link extending from the transmission and up the bag housing , with a top end of the control link being located adjacent to the top of the bag housing . an upper handle assembly having a hand grip reciprocally mounted thereon and a power switch button mounted thereon . the lower end of the upper handle assembly is adapted for connection to the top of the bag housing , such that the upper end of the control link and the hand grip are automatically interconnected when the upper handle assembly is attached to the bag housing . furthermore , the power switch the power button are operatively interconnected when the upper handle assembly is attached to the bag housing .

a self - propelled upright vacuum cleaner 2 according to a preferred embodiment of the present invention is diagrammatically illustrated by way of example in fig1 . the cleaner includes a foot or lower engaging portion 4 . the foot includes a floor nozzle , not visible in fig1 located to the front of the foot . freely rotating support wheels 6 ( only one of which is visible in fig1 ) are located to the rear of the foot . the foot further includes a transmission 8 and drive wheels 10 for propelling the cleaner in forward and reverse over a floor . the details of the transmission do not form a part of the present invention and are therefore not disclosed in detail herein . however , a suitable transmission for use with a self - propelled upright vacuum cleaner according to the present invention is disclosed in u . s . pat . no . 3 , 581 , 591 , the disclosure of which is hereby incorporated herein as of reference . a bag housing or handle portion 12 is pivotally mounted to the foot 4 in a conventional manner for pivotal motion from a generally upright latched storage position , illustrated in fig1 to an inclined pivotal operating position , not shown in fig1 . a hand grip 14 is slidably mounted to a handle stem 16 that is attached to the upper end of the bag housing 12 for limited reciprocal rectilinear motion relative to the handle stem as illustrated by arrow h . the hand grip is connected to the transmission via a bowden type control cable 18 . as an operator pushes and pulls on the hand grip 14 , the cable actuates the transmission to automatically drive the cleaner in forward and reverse in response to the forces applied to the hand grip by the operator . a power switch button 20 is preferably located adjacent to a top of the handle stem near the hand grip for convenient actuation of an electric power switch 22 for turning the cleaner on and off . fig2 and 3 are a partial rear and top view , respectively , of the vacuum cleaner according to the present invention , prior to attachment of an upper handle assembly to be described in detail below . a cavity 24 is formed in the top rear of the bag housing 12 . the cavity is defined by substantially vertical sidewalls 26 and 28 , a substantially vertical inner wall 30 and a substantially horizontal lower wall 32 , such that the cavity is open at the top and at the rear of the bag housing . the control cable 18 extends through a hole ( not shown ) in the lower wall and a mushroom shaped cable end piece 34 is attached to the end of the cable . the cable end piece includes an h - shaped portion 36 , see fig3 that is dovetailed in a slot 38 passing through the inner wall 30 of the cavity 24 , such that the cable end piece is slidably mounted for reciprocal vertical rectilinear motion in the cavity . the electric power switch 22 is also mounted in the cavity on the inner wall 30 , as illustrated in fig2 . the power switch is a rearward facing toggle switch . a substantially horizontally extending peripheral groove 40 is formed in the sidewalls and the inner wall of the cavity . referring now to fig4 through 7 , the upper handle assembly 42 includes the hand grip 14 that is mounted to the top of the handle stem 16 for limited rectilinear reciprocal motion relative to the handle stem . the hand grip includes a grip rod 44 having a lower stem portion 46 and an upper grip portion 48 that is located at an angle relative to the stem portion 46 . a front grip half 50 and a rear grip half 52 are sandwiched about the grip portion 48 of the grip rod such that two snap connections 54 and 56 , located one to either side of each of the grip halves , are snapped together . two screws 58 are then passed through the rear grip half , through the grip portion of the grip rod , and are threaded into the front grip half to secure the grip halves in place upon the grip portion of the grip rod . with particular reference to fig4 and 5 , the handle stem 16 is an upwardly tapering hollow tubular member . a top portion 60 ( see fig5 ) of the handle stem has an inner peripheral surface 62 having a centrally located d - shaped cross section , as best seen in fig4 . a hollow tubular handle sleeve 64 , preferably made of delrin ™, is centrally located in the top portion 60 of the handle stem . the handle sleeve has an outer peripheral surface that approximates a generally d - shaped cross - section . the handle sleeve 64 is non - rotatably received within the d - shaped opening in the upper portion of the handle stem . the handle sleeve also has a d - shaped inner peripheral surface 66 in cross - section . the stem portion 46 of the grip rod has a d - shaped cross section that is sized to be slidably received within the handle sleeve 64 as shown in fig5 . the hand grip 14 is mounted to the top of handle stem 16 by telescopically sliding the stem portion of the grip rod into the top of the handle sleeve until a lower end 66 of the grip rod extends below a lower end 68 of the handle stem . a forwardly opening t - shaped notch 70 is located in the lower end of the grip rod 44 , below the lower end 68 of the handle stem , for receiving the cable end piece 34 , as discussed in further detail below . the d - shaped cross - section of the stem portion 46 of the grip rod , the handle sleeve 64 and the inner surface 62 of the top portion of the handle stem prevent the hand grip 14 from twisting or rotating about the longitudinal axis of the stem portion of the grip rod relative to the handle stem . the upper handle assembly 42 further includes a switch pocket 72 mounted in a recess 74 in the front of the handle stem . a vertically extending ridge 76 ( shown in fig5 ) extends from a rear or inner surface of the switch pocket , through a slot 78 in the recess in the handle stem , through a slot 80 in the handle sleeve , and is received in a longitudinally extending recess 82 in the stem portion 46 of the grip rod 44 , as illustrated in fig5 . with this construction , the ridge on the rear of the switch pocket engages upper 84 and lower 86 extremities of the recess in the grip rod and thereby limits the upward and downward vertical travel of the grip rod 44 , and therefore of the handgrip 14 , relative to the handle stem 16 . the power switch button 20 is vertically reciprocally mounted in a vertically extending slot 88 formed in the switch pocket 72 . the switch button is attached to a switch rod 90 located within the handle stem . as illustrated in fig5 and 6 , the switch rod extends down from the switch button 20 , through an opening in the switch pocket , and out the lower end 68 of the handle stem . a lower end of the switch rod includes a forward facing cam bump 92 for actuating the electric power switch 22 ( not shown in fig4 - 7 ) as explained in further detail below . the switch rod extends through an opening 85 in a guide plate 82 mounted in the open lower end 68 of the handle stem . as discussed above , the ridge 76 on the rear of the switch pocket 72 limits the upward travel and downward travel of the hand grip 14 relative to the handle stem 16 . when an operator pulls on the hand grip , the hand grip moves up relative the handle stem , as viewed in fig5 through 7 , into a reverse position in which the ridge 76 on the switch pocket contacts the lower extremity 86 of the recess 82 in the grip rod . alternatively , when an operator pushes on the hand grip , the hand grip moves down relative the handle stem , as viewed in fig5 through 7 , into a forward position in which the ridge 76 on the switch pocket contacts the upper extremity 84 of the recess in the grip rod . a lockout pin 94 is mounted in a horizontally extending slot 96 passing through the front grip half 50 . the lockout pin extends through the front grip half and is received in a &# 34 ; sideways t - shaped &# 34 ; recess 98 in the front surface of the handle stem 46 . the &# 34 ; top &# 34 ; 100 of the t - shaped recess extends vertically and the &# 34 ; leg &# 34 ; 102 of the t - shaped recess extends horizontally . when the operator locates the lockout pin to the left , as viewed in fig6 in a &# 34 ; propelled &# 34 ; position , the lockout pin extends into the vertically extending &# 34 ; top &# 34 ; of the t - shaped recess for allowing the hand grip to move up and down relative the handle stem to actuate the transmission . alternatively , when an operator moves the lockout pin to the right , as viewed in fig6 into an &# 34 ; unpropelled &# 34 ; position , the lockout pin extends into the horizontally extending &# 34 ; leg &# 34 ; of the t - shaped recess and thereby vertically locks the handgrip in place relative to the handle stem in a neutral position . a peripheral flange 104 extends out from either side and from the front of the lower end 68 of the handle stem 16 . in order to attach the upper handle assembly 42 to the bag housing 12 , the peripheral flange 104 on the handle stem is aligned with the horizontal groove 40 in the cavity 24 in the bag housing as illustrated in fig8 . the upper handle assembly is then moved forward , sliding the peripheral flange on the handle stem into the groove in the cavity in the bag housing until a rear wall 106 extending down from the lower end of the handle stem encloses the cavity in the bag housing . two screws 108 are then passed through holes 110 passing through the downwardly extending wall and are threaded into the bag housing to securely attach the upper handle assembly 42 to the bag housing 12 . as discussed above , and as illustrated in fig5 through 7 , the grip rod 44 and the switch rod 90 both extend out the lower end 68 of the upper handle assembly 42 . the stem portion 46 of the grip rod is positioned within the cavity 24 by the handle sleeve 64 , such that when the upper handle assembly is slid forward in to the cavity , the cable end piece 34 is received in the t - shaped groove 70 in the lower end 66 of the grip rod , as illustrated in fig9 . the cable end piece is thus positively captured in the t - shaped groove , so that when the hand grip 14 is moved up and down relative the handle stem , the control cable 18 is likewise moved up and down for actuating the transmission and propelling the vacuum cleaner in forward and reverse . the hole 85 in a guide plate 87 locates the lower end of the switch rod 90 , such that when the upper handle assembly 42 is slid forward into the cavity 24 the cam bump 92 on the switch rod is located in abutting engagement with the power switch 22 as illustrated in fig1 and 11 . as a result , when the switch button 20 ( not shown in fig1 and 11 ) is pushed down into its &# 34 ; off &# 34 ; position by an operator , the cam bump places the power switch in the &# 34 ; off &# 34 ; position as illustrated in fig1 . when an operator moves the switch button up to its &# 34 ; on &# 34 ; position , the cam bump places the power switch in the &# 34 ; on &# 34 ; position for powering the cleaner as illustrated in fig1 . with this construction , the power switch button 20 may be conveniently located up on the upper handle assembly 42 where it can be easily actuated by an operator without having to stoop . the transmission 8 naturally remains in the unbiased neutral position until it is actuated by a force applied by the control cable 18 . therefore , the hand grip 14 is preferably locked in its neutral position prior to attachment of the upper handle assembly 42 to the bag housing 12 . locking the hand grip in the neutral position ensures that the t - shaped recess in the lower end of the grip rod is properly located to receive the cable end piece 34 therein when the handle assembly is attached to the bag housing . the hand grip is preferably locked in its neutral by first locking the hand grip in the neutral position with the lockout pin 94 , and then inserting a removable tab ( not shown ) into the slot 96 in the front grip half to the left of the lockout pin as viewed in fig6 . the removable tab prevents the hand grip from accidentally moving into the &# 34 ; propelled &# 34 ; position until the tab is removed from the slot . the lockout pin may alternatively be taped or otherwise temporarily fixed in the unpropelled position . the power switch button 20 ( which is illustrated in the &# 34 ; on &# 34 ; position in fig6 ) is preferably retained in the off position by inserting a removable tab ( not shown ) in the slot 88 above the switch button prior to attachment of the upper handle assembly to the bag housing . securing the switch button in its off position ensures that the power switch will remain in the off position , as preset at the factory , until after the upper handle assembly is attached to the bag housing . accidental activation of the electric power switch 22 upon attachment of the upper handle assembly to the bag housing is thus prevented . it will be appreciated that the switch button may alternatively be retained in its off position with tape or any other suitable means . the upper handle assembly is very accurately located within the cavity in the bag housing by the close fit between the peripheral flange 104 on the handle stem 16 and the peripheral groove 40 in the cavity 24 . thus , the t - shaped recess 70 in the grip rod is very accurately guided over the cable end piece 34 as the upper handle assembly is slid horizontally into the bag housing . as a result , the t - shaped recess in the grip rod may be formed just slightly larger than the cable end piece . with this construction , a highly accurate connection is formed between the hand grip and the control cable simply by sliding the upper handle assembly horizontally into the cavity in the bag housing prior to removing the removable tab holding the lockout pin in place . since the cable end piece and the control cable are mutually engaged by horizontally sliding the upper handle assembly into the bag housing , there is no danger of vertically displacing the cable end piece when making this connection . as a result , the control cable 18 does not have to be connected to the hand grip 14 at the factory in order to ensure that the control cable is accurately adjusted to place the transmission in forward and reverse as an operator pushes and pulls on the hand grip . the control cable is preferably calibrated at the factory by temporarily attaching the upper handle assembly to the bag housing , neutralling the transmission actuator arm with the hand grip locked in neutral by the lockout pin , and then tightening a screw that clamps the lower end of the control cable to the actuator arm . it will be appreciated that any suitable control link may be substituted for the disclosed the bowden control cable without departing from the scope of the present invention . for example , a flexible strap , a rigid link or a system of rigid links may be substituted for the control cable . the present invention thus enables an accurate connection between the control cable and the hand grip to be reliably made by a consumer simply by attaching the upper handle assembly to the bag housing prior to removing the removable tabs . as a result , the self - propelled vacuum cleaner according to the present invention may be shipped with the upper handle assembly 42 unattached . shipping the cleaner with the upper handle assembly unattached enables the cleaner to be shipped in a much smaller carton than when the cleaner is shipped with the upper handle assembly attached to the cleaner , thereby creating savings in packaging and shipping costs . the present invention has been described above using a preferred embodiment by way of example only . obvious modifications will become apparent to one of ordinary skill upon reading the above description and viewing the appended drawings . the present invention described above and as claimed in the appended claims is intended to include all such obvious modifications within the scope of the present invention .

US-7484598-A

a method and apparatus for monitoring cardiac activity starting from a series of images of the heart made by x - rays . attenuation of the x - rays is sampled on an area subject to repetitive thickenings of at least one wall of the heart , and a repetitive attenuation signal is interpreted as a signal representative of the heart activity .

an embodiment of the invention obtains a series of images like those illustrated in fig1 . each image is inscribed within an acquisition field 100 of the rectangular type corresponding approximately to the entire display area of the screen 200 . the heart 300 is approximately at the center of the acquisition field shown in fig1 a in the form of two adjacent rings 310 and 320 , these rings 310 and 320 diagrammatically representing the right ventricle 310 and the left ventricle 320 . in fig1 b , which conforms more to the projective nature of the imaging system , the heart is represented as a gray elliptical shape . obviously , these representations are very diagrammatic , since the image of the heart can have different orientations depending on the position of a sensor and a radiation source , such as x - rays . moreover , in practice the view is not a sectional view like that shown diagrammatically in this case in fig1 a , but is a projective view like that shown in fig1 b . in other words , each pixel of the acquisition field is a projection of a set of attenuations encountered along an axis that connects the pixel considered to the x - ray source . there are variations in the thickness of heart walls , in other words variations of the quantity of tissue through which all the projection axes of a given sampling area pass . in this context , we are interested in variations of wall thicknesses on an area covering part of the heart that is delimited approximately by the outside shape of the heart . in this case , this area is inscribed within a circle 400 , shown in dashed lines in fig1 a and 1b , that is chosen to approximately surround the image of the heart . it is only slightly larger than the projection of the heart , such that it is approximately flush with the sidewalls of the heart . the attenuation of radiation in this area is transformed into an equivalent water depth , in other words , the water depth that outputs the same intensity pixel as that displayed on the screen in the area in question . this is done using lambert &# 39 ; s law that defines the attenuation of a monochromatic x - ray as follows : i = i max - μ ⁢ ⁢ h ⁢ ⁢ =& gt ; ⁢ ⁢ h - 1 μ ⁡ [ log ⁡ ( i max ) - log ⁡ ( i ) ] where h is the equivalent water depth , μ is the attenuation coefficient and i max is the maximum intensity of the image , where μ is equal to about 0 . 02 mm − 1 , for linear attenuation of water under an exposure at 80 kv . the intensity i is the average intensity sampled at each instant inside a monitoring area , in other words in the area affected by variations in the thickness of the walls of the heart . the monitoring area 600 will be called a region of interest ( roi ). in this example , the imaging apparatus is provided with image intensity slaving means , in a manner conventional in itself . the purpose of these slaving means is to maintain a constant average intensity in an area that also covers a non - negligible part of the heart . this area is shown cross - hatched as reference 500 in fig1 a and 1b . it is a central disk with a dimension conventionally less than the image of the heart on the screen . the slaving means measures the average intensity in the disk 500 by integrating all pixels on this disk , and then modulates the intensity of x - rays on emission , such that this average intensity reaches a predefined set value . in other words , the central disk 500 only has very small intensity variations , even within a heart cycle , since the slaving loop acts in a real time to keep the intensity constant . the central slaving disk 500 is extracted from the area used for observation of attenuation variations . typically , this eliminated part will cover 50 % of the projection field 100 . thus , the area in which the thickness of the wall passed through is monitored , is limited to a ring 600 , delimited on the outside by the previously described circle 400 , and delimited on the inside by the periphery of slaved disk 500 . ring 500 is precisely the area in which the greatest variations of wall thickness occur , since it transversely covers the walls of the left and right ventricles . in other words , ring 600 covers walls for which the variable thickness forms a mask with a variable size in front of the x - ray beam . in other words , the sampling area is placed such that the heart has at least one wall for which the projected thickness has a variable range in the sampling area . the average intensity integrated on all pixels in ring 600 varies with time as shown in fig2 , in which each peak corresponds to the systolic phase of a beat . these peaks are distributed with a generally increasing variation , since in this case the test was done while a contrast material was being injected . this contrast material is used for other purposes , and is not necessary for implementation of embodiments of the invention . thus , the water depth signal resulting from this processing has a quasi - periodic variation superposed to the gradual variation due to injection of the contrast material into the epicardial artery and its perfusion into the myocardium . the plot obtained by an intensity reading of this type is particularly meaningful . the plot in fig2 is used by a calculation step that comprises calculating a correlation function expressed by the following equation : r ⁡ ( k ) = ∑ t ⁢ s ⁡ ( t ) · s ⁡ ( t + k ) in this equation , r is the autocorrelation function , s is the time signal in fig2 , t is the time as integrated on this signal and k is the variable of the autocorrelation function , also expressed as a time . the plot of the autocorrelation function , as shown in fig3 , is itself in the form of a series of successive peaks , the first of which is positioned at an average value of the periods of the heart signal . subsequent peaks are multiples of the average period . the function outputs are a particularly precise average value t for the period . this average value s is used in a subsequent step in which t is compared with the duration of each beat encountered on the plot in fig2 . thus , individual elongations or shortenings of each beat are identified , which helps to identify each given phase of the heart configuration during the different beats . in other words , elongations and shortenings of periods identified by comparison with this average value t provides a means of extracting synchronous images belonging to different beats . by subtraction between these synchronous images , contrasts due to tissues not impregnated by the contrast material , in other words tissues with lesser interest and particularly tissues other than heart tissues , are eliminated . in another embodiment of the invention , the intensity reading is in the form of an attenuation profile produced transversely to at least one wall of the heart . to achieve this , attenuation values used will be restricted to pixel segments directed transversely to the image of the heart . thus in fig4 , a first segment 700 is a segment specifically oriented at 30 ° from a main longitudinal axis x of the heart . a second segment is a segment 800 , positioned at 60 ° from the longitudinal axis x . these orientations at 30 and 60 ° are chosen to intersect the walls of the ventricles and to obtain profiles independent of the orientation of the mechanical arc supporting the x - ray imaging device . therefore , the sampling area ( the segment considered ) is positioned such that the heart has at least one wall for which the range of the projected thickness is variable within the sampling area . intensities of pixels are recorded on each of these segments 700 and 800 , and these intensities are displayed as a function of the degree of progress on this segment considered ( fig5 ) in the form of a transverse attenuation profile of the heart . more specifically , an average profile 900 is produced by taking the average of the two profiles for segments 700 and 800 . in this case , this average profile 900 as shown on fig5 and 6 has two main elevations 910 and 920 . each corresponds to the intersection of the sampling segment and the walls of the left ventricle , in which the thickness passed through is particularly high . this profile 900 also has a significantly lower additional elevation 930 , corresponding to a wall of the right ventricle . significant differences appear between the profiles in fig5 and fig6 . thus , it can be seen that the elevations are significantly more pronounced in the systolic phase ( fig6 ) since the walls encountered are thicker due to the contraction of the ventricles . elevations 910 and 920 have a more pronounced height corresponding to more pronounced thicknesses of the walls , passing through the sampling area . this contraction also causes shrinkage of the cavity 940 internal to the main elevations 910 and 920 corresponding to shrinkage of the internal cavity in the right ventricle . these two modifications of the profile 900 are used ( fig7 ) to output a signal representative of the thickness of the heart walls , and therefore the heart activity . to achieve this , in this case the profile 900 is analysed as being an assembly of two parabolas . the first parabola 950 is considered as being the shape of the external silhouette of the profile . in other words , the external curvature of the two main elevations 920 and 910 is similar to the side of a parabola for which the vertex overhangs the upper cavity 940 . the position and curvature of this parabola are identified by automatic shape recognition means integrated into the imagery device processing means . the second parabola 960 corresponds to the curvature and depth of the upper cavity 940 . in other words , the inner sides and the bottom of this cavity are considered as defining a parabola ( curvature and position ). therefore , the profile 900 defines a pair of parabolas 950 and 960 at each instant , for which the parameters ( curvature and position ) are unique . when the profile 900 varies during a heart movement , the parabolas 950 and 960 thus positioned vary accordingly . other analytic curves could also be adopted , but the parabola is a desirable analytic curve for implementation . it is also found that the curvature of the external parabola 950 varies accurately as a function of the width of the profile 900 , and is consequently a parameter for measuring the distance separating the outside walls of the right ventricle ( and more generally the heart ). the curvature of the internal parabola 960 represents the width of the internal cavity of the ventricle . thus , the curvature of the parabola 960 varies as a function of the internal thickness of the heart . these two curvatures are taken into account by making a weighted linear combination of them . in this case this weighted average is a simple difference between these two curvatures . this difference may be considered as being an accurate measurement of the thickness of the ventricle walls . these curvatures thus correspond to the inside and outside radii of curvature of the heart in the area thus observed . it varies with time as shown in the plot in fig8 . this variation comprises a series of repetitive peaks corresponding to the systolic phases distributed over a gradual variation corresponding to the injection of a contrast material . however , the contrast material is not necessary for observation of these peaks , and therefore for monitoring the heart activity in itself . as in the above embodiments , this plot is used to calculate correlation function in order to accurately define the average duration of heart cycles and also to make good use of them in terms of processing synchronous images . the embodiments of the invention and equivalents thereof may be used in the context of recorded images ( particularly after circulation of the contrast material in the arteries network ) and in the context of angioscopic images . the different means described above for efficient monitoring of heart activity are for example controlled by software capable of carrying out the different processing steps when it is implemented on an appropriate processor . one skilled in the art may make or propose various modifications to the structure / way and / or function and / or results and / or steps of the disclosed embodiments and equivalents thereof without departing from the scope and extant of the invention .

US-11437805-A

a non - invasive nuclear device for communicating pressure inside a body to the exterior , such as from within the cranium , bladder or vena cava , of an animal or human , the device including a housing having an interior communicating through a conduit of deformable metallic material with a fluid pressure sensing device positioned within the body portion being monitored , the housing being mounted on the body adjacent the body portion being monitored , a shaped mass of radioactive material together with radiation shield means being disposed within the housing interior together with urging means for producing a predetermined shielding relationship between the radioactive mass and the shield means , the radioactive mass being supported on the urging means for guide movement relative to the shield means and the sensed pressure being exerted through a pressure transmitting fluid flowing within the deformable metal conduit against the urging means for modifying the shielding relationship between the radioactive mass and the shield means proportionally with a change in fluid pressure in the body cavity thereby producing a radioactive output from the radioactive mass corresponding to the magnitude of the fluid pressure in the body position being monitored together with an ambient pressure sensing device mounted on the housing for applying ambient pressure through a pressure transmitting fluid to the urging means in opposition to the sensed body cavity pressure to compensate for changes in ambient pressure .

referring now to the drawings and to fig1 and 2 in particular , there is shown the pressure sensing apparatus of the invention with a housing designated generally by the numeral 10 , and fluid pressure responsive means designated generally by the numeral 11 and connected to the housing 10 for sensing the fluid pressure in a body portion such as a cavity . ambient pressure responsive means , designated generally by the numeral 12 , is also provided on the housing 10 which is responsive to ambient pressure to compensate for changes in ambient pressure during the operation of the invention . although the pressure sensing apparatus of the invention is shown in an installed position on the head of a human body for non - invasively monitoring intracranial cavity pressure and communicating it to the exterior , it should be understood that this is only a preferred example of the invention and that it is equally adaptable for monitoring fluid pressure in other areas of the body , both animal and human . therefore , while the description to follow will be directed to the use of the invention for monitoring intracranial cavity pressure , it should be understood that the invention is equally applicable to monitoring fluid pressure in other body portions and cavities . referring now to fig3 and as specifically illustrative of the invention , the housing 10 , which is formed of titanium , is preferably of tubular shape having a side wall 13 defining an interior 14 . a first support member 16 formed of titanium having a central bore 17 is positioned within one end of the housing 10 in sealing relationship with the housing side wall 13 by means of an epoxy resin or the like . preferably , an annular shoulder 13a is formed in the housing side wall 13 for positioning the support member 16 in a precise location within the housing 10 as will be explained hereinafter . the first support member central bore 17 is provided with a first portion 17a of slightly enlarged diameter and a second portion 17b of substantially enlarged diameter defining a recess 20 which communicates with the interior 14 of the housing 10 . the fluid pressure responsive means 11 includes a fluid conduit 22 of deformable metallic material preferably titanium which has been heat treated for deformability , one end 22a which is arranged to be connected to a fluid pressure sensing device or tambour 23 having an interior 24 which is arranged to be positioned within a body cavity such as the intracranial cavity of fig1 . the tambour 23 is formed of a suitable elastomeric material such as medical grade silastic rubber and is of a substantially flat configuration including a neck portion 25 in the wall of which is molded a helical spring 26 preferably of stainless steel for imparting rigidity to the neck portion 25 . the neck portion 25 includes a central bore 25a which communicates with the interior 24 of the tambour 23 and which is arranged to receive the end 22a of the conduit 22 as shown in fig2 . preferably a u - shaped clip 27 of tantulum or the like is disposed within the interior 24 of the tambour 23 for maintaining the side walls of the tambour in spaced - apart relationship and to serve as a locating means for the tambour with the use of x - rays . the tambour or fluid pressure sensing device 23 , the fluid conduit 22 and the communicating portions of the housing interior 14 , including the recess 20 , are filled with a pressure transmitting fluid through which the pressure sensed by the tambour 23 in the body cavity is transmitted to the housing interior 14 . the other end 22b of the conduit 22 is swaged to a suitable enlarged outer diameter so as to conform generally to the inner diameter of the enlarged portion 17a of the first support member central bore 17 . the conduit end 22b is pressfitted into the bore portion 17a with the conduit 22 extending through the bore 17 as shown best in fig3 . sealing engagement between the conduit 22 and bore 17 is obtained by means of epoxy resin . thus , the conduit end 22b communicates with the recess 20 and with the housing interior 14 . a source 29 of radioactive material preferably in the form of a shaped article is disposed within the housing interior 14 together with radiation shield means designated generally by the numeral 31 . means are provided in the housing interior 14 for yieldingly urging into a shielding relationship . more specifically , urging means such as a bellows 32 having an interior 33 is disposed within the housing interior 14 , one end 32a of which is mounted on a necked - down portion 34a of a second support member 34 preferably formed of titanium and suitably mounted in the other end of the housing 10 in sealing engagement with the housing side wall 13 by means of an epoxy resin or the like . the other end 32b of the bellows 32 is closed as will be explained hereinafter . the second support member 34 is provided with a central bore 38 and the necked - down portion 34a is arranged to support the bellows end 32a in a sealing relationship therewith by means of an epoxy resin 41 or the like . the central bore 38 of the second support member 34 includes a portion of enlarged diameter forming a recess 42 and which is provided with an annular , inwardly directed flange 43 . the recess 42 receives the nipple 44 having a central passage 44a of an ambient pressure sensor or tambour 46 forming the ambient pressure responsive means 12 . the tambour 46 is formed of a flexible material , preferably an elastomeric material such as medical grade silastic rubber , and includes an annular peripheral portion 47 and a recessed central portion 48 defining an interior 49 extending through the nipple central passage 44a . a suitable adhesive such as a medical grade silastic adhesive , seals the nipple 44 in the recess 42 and the annular flange 43 compresses the outer surface of the nipple 44 to form a mechanical compression seal to securely retain the nipple 44 in the recess 42 . a rigid metal tube 51 , preferably formed of titanium , is also sealed in nipple 44 and by a silastic adhesive and extends through nipple central passage 44a and the central bore 38 of the second support member 34 into the bellows interior 33 to communicate the interior 49 of the tambour 46 with the bellows 32 . the other end 51b of the tube 51 forms a stop for the bellows end 32b . in order to transmit the sensed ambient pressure to the interior of the bellows 32 , the interior of tambour 46 , the bellows interior 33 and the tube 51 are filled with a pressure transmitting fluid , isolated by means of the bellows 32 from the pressure transmitting fluid in the fluid pressure responsive means 11 . in the preferred embodiment , all of the exposed metallic surfaces of the sensing apparatus of the invention are coated with a suitable biocompatible material , such as a medical guide silastic adhesive . as shown in the drawings , this silastic adhesive 50 extends from the nipple 44 of tambour 46 to the joint between the metal conduit 22 and the neck portion 25 of tambour 23 . in the illustrated embodiment , the radiation shield means 31 includes a first portion 53 of radiation shielding material such as tantalum having a cup - shaped configuration . the first portion 53 preferably includes an end plate 54 preferably in the form of a disc and an annular side member 56 both mounted on the other end 32b of the bellows 32 in closing relationship therewith as shown best in fig4 . the radiation shield means first portion 53 is mounted on an inwardly directed channel portion 57 adjacent the last accordion pleat in the bellows 32 , and a tubular sleeve portion 58 extending axially outward therefrom which together define an enclosure 59 . the end plate 54 is adhesively secured in the end of the enclosure by a suitable adhesive such as an epoxy resin closing the end 32b of the bellows 32 . similarly , side member 56 is adhesively secured by means of an epoxy resin to sleeve portion 58 . the radiation shield means also includes a second portion 61 in the form of a tubular sleeve of radiation shield material , also preferably tantalum which is press - fitted or the like within the recess 20 of the first support member 16 . it can be seen that the second portion 61 extends throughout the depth of the recess 20 and has a forward end edge portion 61a terminating flush with the end of the first support member 16 abutting the housing side wall shoulder 13a . thus , the second portion end 61a is precisely positioned axially in the housing interior 14 adjacent the end edge portion 56a of the first portion side member 56 . radioactive source 29 is mounted on the end 32b of the bellows 32 and is slidably accommodated for guiding movement within the radiation shield means second portion 61 disposed in the recess 20 . the radioactive source 29 which is preferably of cylindrical shape , having an outer diameter conforming generally to the inner diameter of the bellows sleeve portion 58 is adhesively secured within the enclosure 59 defined by the tubular sleeve portion 58 by means of a suitable adhesive such as an epoxy resin . the end cap 62 having a meniscus 62a is formed by the adhesive material . the bellows 32 yieldingly urges the radioactive source 29 , together with the sleeve portion 58 , in the direction of the arrow i into the recess 20 with the edge portion 56a of the radiation shield means first portion side member 56 in adjacent cooperating relationship with the edge portion 61a of the tubular sleeve forming the radiation shield means second portion 61 to establish a shielding relationship with the radioactive source 29 . the end cap 62 is therefore disposed oppositely the outlet end 22b of the pressure transmitting fluid conduit 22 . the outer diameter of the bellows sleeve portion 58 is selected to produce a loose - fitting relationship with the inner surface of the sleeve forming the radiation shield means second portion 61 so that fluid introduced into the recess 20 from the end 22b of conduit 22 may flow freely therebetween and through a gap between the front and second portions end edge portions 56a and 61a respectively to fill the interior 14 of the housing 10 on the outside of the bellows 32 . it should be understood that in the assembled apparatus of the invention before installation in a body there is virtually no pressure differential in the housing 10 between the pressure - transmitting fluids on opposite side of the bellows 32 . in this condition , there is a gap between the adjacent end edge portions 56a and 61a of the first and second portions 53 and 61 respectively . when the apparatus is installed in the body , the normal fluid pressure in the body cavity slightly increases the pressure on the tambour 23 , introducing additional pressure transmitting fluid into the housing interior 14 on the outside of bellows 32 , moving the bellows in the direction of the arrow d , thereby increasing slightly the gap between the end edge portions 56a and 61a . in the operation of the invention after installation , an incease in fluid pressure is sensed in the body cavity by the fluid pressure sensing device or tambour 23 , the sensed pressure is transmitted by the pressure - transmitting fluid flowing into the support member recess 20 through the end 22b of conduit 22 around the end cap 62 through the gap between the edge portions 56a , 61a to move the bellows 32 together with the radiation shield means first portion 53 and the radioactive source 29 in the direction indicated by the arrow d in opposition to the urging force exerted by the bellows . during this movement , the radiation shield means first and second portions 53 , 61 move apart increasing the gap proportionally with the increase in cavity fluid pressure thereby modifying the shielding relationship between the shield means 32 and radioactive source 29 to expose more of the radioactive source in accordance with the magnitude of the cavity pressure . the radioactive output of the exposed portion of the radioactive source 29 may then be sensed by a conventional nuclear counter or crystal detector disposed externally of the housing 10 and the body . the provision of the ambient pressure responsive means 12 permits the sensing apparatus of the invention to be responsive to pressure changes in the body cavity regardless of ambient pressure changes . accordingly , ambient pressure changes are imposed equally on both the ambient pressure responsive means 12 and the cavity pressure responsive means 11 whereby the sensing apparatus of the invention responds to body cavity pressure changes only . to insure a long life for the sensing apparatus of the invention commensurate with body compatability , it has been found that specific non - reactive fluids and elastomeric materials eliminate such reactions . more specifically , the best results that have been obtained are when the elastomeric material of the various components are formed , in one example , from a silastic type of silicone rubber and the pressure transmitting fluids are either castor oil or mineral oil between which there is virtually no chemical or physical reaction thereby insuring proper functioning of the invention throughout its life . it has also been found that when the pressure transmitting fluid is a silicone oil , the outstanding results of the invention are accomplished when the materials are selected from the group consisting of butyl , neoprene , buna n and viton a rubbers . it should be understood , however , that other elastomeric materials and fluids perform satisfactorily but with less desirable results . one major concern in selecting a fluid is the osmotic pressure effects produced during implant . it is preferred to eliminate these effects that a simulated cerebrospinal fluid be used as the pressure transmitting medium and it may be used with all materials of construction as it will be compatible with body fluids and will not leak through the elastomeric materials as a consequence of osmotic pressure . in the use of the invention to monitor the fluid pressure within an intracranial cavity and with reference to fig5 - 7 , the common practice is to provide a burr hole or aperture 70 within the bony structure of skull 71 overlying the intracranial cavity through which the metallic fluid conduit 22 is inserted , the cavity pressure sensing device 23 being suitably disposed within the intracranial cavity . the housing 10 , together with the ambient pressure responsive device 12 are mounted on the outer surface of the skull 71 under the scalp 72 . the apparatus of the invention includes means for permanently mounting the housing 10 and ambient pressure responsive means 12 subcutaneously on the outer surface of the skull 71 in an inconspicuous , securely retained position . more specifically , an elongated concave groove 73 is formed within the outer surface of the skull 71 adjacent the burr hold 70 , and mounting means are provided for securing the housing 10 in a seated relationship within the groove 73 . the mounting means includes at least one , preferably two , tabs 74 arranged in longitudinally spaced relationship on the housing 10 as shown best in fig5 . each of the tabs 74 includes an intermediate portion 76 of arcuate cross - sectional shape for accommodating the tubular housing 10 in underlying engagement therewith . the tab portion 76 is secured to the outer surface of the housing 10 by suitable means such as a body compatible adhesive , welding or the like . the tabs 74 also include oppositely disposed end portions 77 and 78 extending laterally outward of the housing 10 secured within the intermediate portion 76 . openings 79 , 81 are provided in the tab end portions 77 , 78 respectively for accommodating screw means such as screws 82 extending therethrough in threaded engagement with the underlying bone of the skull 71 , and with the end portions 77 , 78 in overlying engagement with the outer surface of the skull 71 , the tab intermediate portion 76 and housing 10 being accommodated within the groove 73 . in the preferred embodiment , the tabs 74 are preferably formed of a radiation shielding material such as tantalum . one of the tabs 74 is positioned on the housing 10 with its intermediate portion 76 extending throughout the path of movement of the radioactive source 61 within the housing . thus , not only does the one tab 74 prevent downwardly directed radiation into the body , but the radioactive output of source 29 is confined in a non - attenuating manner to the upward directin to permit easy detection by an externally positioned detection device . the output of the radioactive source 29 need only be of an extremely low order of magnitude typically less than 0 . 1 microcurie , a magnitude far less than that at which the adjacent body tissue may be adversely affected . however , it should be characterized by an extremely precise and uniform output rate which accurately reflects the changes in fluid pressure within the body cavity throughout its range of operation . the preferred radioisotope used in the present invention is promethium - 145 and to obtain the proper radioactive output from the source 29 , it should be in the form of a shaped article of highly homogeneous composition . accordingly , another novel feature of this invention is provision of such a shaped article of radioactive material . the radioactive source 29 comprises promethium chloride ( pmcl 3 ) uniformly distributed and absorbed onto an inert carrier such as diatomaceous earth and uniformly distributed throughout a suitable binder such as an epoxy resin . sources 29 of this composition are extremely uniform regarding the concentration or distribution of the pmcl 3 . although the invention has been described in terms of a single preferred embodiment , nevertheless , changes and modifications will appear evident to those skilled in the art , such as within the purview of the claimed inventive concepts .

US-59271875-A