US3734087A - External pressure circulatory assist - Google Patents
External pressure circulatory assist Download PDFInfo
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- US3734087A US3734087A US00197824A US3734087DA US3734087A US 3734087 A US3734087 A US 3734087A US 00197824 A US00197824 A US 00197824A US 3734087D A US3734087D A US 3734087DA US 3734087 A US3734087 A US 3734087A
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- pressure
- bladder
- patient
- limbs
- pump
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
- A61H9/00—Pneumatic or hydraulic massage
- A61H9/005—Pneumatic massage
- A61H9/0078—Pneumatic massage with intermittent or alternately inflated bladders or cuffs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
- A61H31/00—Artificial respiration or heart stimulation, e.g. heart massage
- A61H31/004—Heart stimulation
- A61H31/006—Power driven
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
- A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
- A61H2201/01—Constructive details
- A61H2201/0103—Constructive details inflatable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
- A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
- A61H2201/12—Driving means
- A61H2201/1238—Driving means with hydraulic or pneumatic drive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
- A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
- A61H2201/16—Physical interface with patient
- A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
- A61H2201/1645—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support contoured to fit the user
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
- A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
- A61H2201/50—Control means thereof
- A61H2201/5058—Sensors or detectors
- A61H2201/5071—Pressure sensors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
- A61H2205/00—Devices for specific parts of the body
- A61H2205/10—Leg
Definitions
- ABSTRACT Improved external pressure circulatory assist device of the type which utilizes an electrocardiogram signal to facilitate synchronization of its pressure pulse with the heartbeat.
- the improvements include a more efficient and clinically suitable mechanical means to induce pressure variations in the legs of a patient, and an automatic control means to maintain the proper pressurization even during physiological changes in the limbs of the patient being treated, and control means to monitor and adjust the pressure wave to achieve the proper phasing of the pressure wave with the cardiac cycle during treatment of the patient.
- This invention relates to a novel apparatus for assist ing blood flow through the circulatory system by synchronizing the pulsing of an external-assist means with the heartbeat.
- the invention also relates to a novel con trol processes achieved by use of the apparauts.
- synchronous external pressure assist processes are distinguishable and advantageous over pre-existing counter-pulsation processes because the latter kind of precedure involves the cannulation of a major artery, use of an extra-corporeal blood handling device, the use of stringently sterile techniques and the necessity of administering anticoagulants to the patient.
- the blood trauma or hemolysis produced by extra-corporeal pumping devices limits premissible duration of the assist procedure and compromises the condition of the patient.
- these trauma-requiring procedures are not only time consuming, they can present a very significant hazard to many patients, and they increase the risk factor in treating all patients.
- the apparatus suggested in such prior art has a number of drawbacks in that it is cumbersome to use; i.e., the patient is inserted into and removed from the device with excessive effort; and it is excessively difficult to achieve the proper pressure-pulsation profile and impossible to achieve what the inventors believe is the more advantageous mode of operation, i.e., at an ambient pressure at or below atmospheric pressure.
- the external counterpulsation method e.g., as generally described in the Birtwell application
- the external counterpulsation method is the only controlled method of assist which requires no surgical intervention or sterile procedures, no use of anticoagulants or anesthesia, and produces no significant trauma.
- These factors are most important because they usually allow a much earlier use of the apparatus on a patient in, say, a state of circulatory shock than could be justified if another type of assist apparatus had to be used.
- the selective application of positive and negative pressures to the portion of the vascular bed in the legs serves to control directly the volume of blood within that portion of the vascular bed and, hence, the pressures within the arterial system, particularly the pressures of the aorta. It is these controlled changes in aortic pressure that lead directly to a reduction in cardiac work, to increased perfusion of the systemic circulation, and to preferential perfusion of the myocardium.
- Another object of the invention is to allow such a person of ordinary skill to easily achieve a precise phasing of a system with the patients heartbeat.
- a further object of the invention is to provide apparatus which is sufficiently quiet to permit its convenient use within a hospital environment.
- a further object is to provide apparatus which can operate with a minimum AC power supply requirement.
- Still another object is to provide automatic control of the pressure waveform applied to a particular patients legs in a circulatory assist process despite a large range of patient leg sizes, geometries, and firmness.
- Another object is to provide apparatus which is light in weight and capable of being simply and rapidly applied to a patient.
- a Water-Fill System The Water-Fill System is used to fill a leg-enclosing bladder with the correct volume of waterfor the particular patient.
- correct volume is meant the particular volume that is suitable for the particular size and geometry of an individual patients legs. It has been found also that because of patient movement into or out of the machine, a patients legs can change their effective size during treatment.
- the water-fill system if utilized not only to properly fill and automatically empty water from the leg encasing bladder; it is also used to add or remove water during treatment, thereby to maintain an efficient hydraulic pressure coupling between a mechanical pressure-inducing means to be described below and the patients legs.
- a pressure sensor which is positioned between the shell which encloses the bladder and the bladder itself senses the pressure in the bladder.
- the filling action is terminated by shutting off the fill pump.
- This filling operation is normally carried out with the platen in its upward position; i.e., in a bladdercompressing position.
- a displacement sensor which is coordinated with the moving platen determines the position of the platen at the topmost position of each upward stroke. If this position is improper, water is pumped into or out of the bladder until the platen again reaches its proper range.
- leg-enclosing bladder be capable of exerting a positive pressure on the legs during cardiac diastole and removing the pressure or producing a negative pressure on the leg (say, to minus 50 mm of mercury) during cardiac systole.
- the positive pressure applied is normally between about 150 to 250 millimeters of mercury.
- the bag although conveniently of flexible material, is held away from the legs by the rest of the apparatus so that a low pressure zone is maintained in which negative pressure can be realized.
- the bag or suction envelope is suitably sealed at the waist by means of a snug fit of its waistband with the body of the patient.
- the apparatus as described above has a normal operating cycle ranging within from about minus 50 millimeters of mercury to plus 250 millimeters of mercury. In operation, the pressure will be cycled with the lower pressure of the cycle corresponding with the systolic phase of the hearts action and the higher pressure corresponding with the diastolic phase.
- the bladder which is advantageously a singlechambered blanket, is placed around the patients legs and a rigid casing is used to enclose both the legs and the mechanical pressure-transmitting platent.
- the bladder is then filled with water until the entire region around the legs and above the platen contains water and so that the bladder is in contact with substantially the entire surface of the legs is fully expanded at the ankle and waist ends. From this point on, the vertical reciprocating action of the platen will provide the desired positive/negative-pressure cycling.
- C. Pressurization Waveform Control To achieve counterpulsation, the pressure on the patients legs should fluctuate according to a desired waveform.
- the apparatus of the invention advantageously comprises a feature whereby the pressure at the legs is monitored, and made the source of a feedback signal which is directly compared to a signal which is representative of the desired waveform for the particular patient.
- the difference between the signal derived from the actual waveform and the signal representative of the desired waveform is called the error signal.
- This error signal is amplified and used to control an electrically operated servo-valve which controls the flow of hydraulic fluid to a hydraulic cyclinder which drives the vertically-reciprocating platen. This flow is continuously adjusted in proportion to the error signal causing the pressure waveform at the transducer to be a suitable facsimile of the desired waveform.
- the monitoring of the pressure at the legs is conveniently done by a water bladder, approximately 4 by 4 by inches in dimensions, which bladder is placed between the bladder-enclosing shell and the bladder itself.
- Water in this sensor bladder is connected through a short tube to a pressure transducer which provides the required electrical signal of the actual pressure waveform.
- a particular advantage of this waveform control system is that it ensures the important characteristics of the desired waveform (e.g., duration, rise, and fall time) as applied to the patients legs are not distorted. This is accomplished in spite of variations in hydraulic coupling between the platen and the legs resulting from such things as differences in leg geometry, size, and firmness from patient to patient, and any dynamic stretching of the bladder or distortions in the leg casing during operation.
- Phasing the Pressure Cycle with the Cardiac Cycle It can be shown that a deleterious, physiological effect may be suffered if the heart is taxed by an improper timing of the start of the external assist pressure wave with respect to the cycle of the heartbeat itself. Moreover, though this phenomenon may be readily understood by an operator, it is desirable to avoid chance of operator error and to simplify the operation of the device by providing a simple, accurate, automatic phasing means.
- the inventors have provided a suitable visually monitored phasing control system whereby an arterial waveform is displayed on a multi-channel oscilloscope or other suitable display device the conjunction with an ECG waveform.
- the arterial pressure waveform is measured at any convenient place on the body. Normally, the wrist will provide the most convenient placement of the arterial wave pressure sensing device.
- the ECG signal will, as is normal, but obtained by placeintroduced in the femoral arteries with the apparatus of the invention, to reach the root of the aorta.
- the subsequent transmission from the root of the aorta to the wrist, where the arterial waveform is typically obtained, takes another 90 ms. It is important that the artificially induced positive pressure waves be produced in the legs sufficiently before diastole (80 ms) and that the pressure wave reaches the root of the aorta at the beginning of diastole.
- the induced pressure wave initiated by a command signal timed to start 170 ms before the arterial wave, as seen at the wrist indicates the beginning of diastole and 80 ms before the ECG signal indicates the beginning of diastole.
- the beginning of diastole is indicated in the arterial wave by the so-called dicrotic notch in good approximation by the end of the so-called T-wave which is known to be positive indication of the relaxation of the left ventricle and the end of systole.
- the leg pressurization signal is used to intensify the ECG and arterial trace on the oscilloscope after this pressurization signal has been delayed for 80 and 170 ms respectively.
- the duration of intensification is the duration of each positive pressurization cycle of the leg.
- a novel leg-encasing unit is employed which, by virwe of its light weight and geometry, provides an efficient casing within which to apply pressurization to the legs, yet is convenient and rapid to apply to a patient.
- E. Platen Driving Mechanism A novel mechanical linkage arrangement is provided for coupling the platen to the driving hydraulic cylinder whereby a suitable pressure-displacement characteristie is obtained at the platen for pressurizing the bladder while at the same time minimizing the input power requirements of the apparatus.
- FIG; 1 is a schematic cross sectional view of that ap paratus of the invention into which the legs of the patient fit.
- FIG. 2 is a plan view of the leg-enclosing apparatus broken away to show the position of a reciprocating platen.
- FIG. 3 is a chart indicating the relative timing of physiological events relative to the description of the invention.
- FIG. 4a and 4b taken together, form a schematic diagram of a unique control system for use in external pressure circulatory assist apparatus.
- FIG. 5 is a perspective view of a platen assembly used to transmit pressure to a leg-surrounding bladder.
- FIG. 6 is a perspective view of the rigid casing into which the patients leg and bladders are placed and the means for quick connection of the casing.
- legs 20 are placed within blanket-like bladder 22 which is filled with a non-compressible liquid, e.g., water 23.
- Bladder 22 completely encloses legs 20 and is adapted for a snug fit within a rigid casing 24 formed of an upper shell 26 and a lower shell 28.
- a platen 30 mounted for reciprocal vertical motion imparted by a mechanical linkage 32. This linkage is driven by a hydraulic cylinder as better seen in FIG. 5.
- a pressure-sensitive transducer 34 is placed in hydraulic communication with the bladder for use in monitoring the pressure therein; the particular function of this transducer will be described below.
- FIG. 2 illustrates how an envelope 36 encloses the casing 24.
- the envelope 26 and casing 24 are broken away to illustrate the relative position of platen 30. It will be noted that the envelope extends beyond casing 24 and is adapted to form a snug fit with waist 38 of a patient 40.
- a suction pump 39 will normally be used to maintain the normal environment within envelope 36 at a sub-atmospheric pressure.
- ECG curve 402 related in real time to a typical cardiac period of 840 ms.
- the beginning of diastole is typically signitied by the start of the drop of the curve at 403.
- This drop at 403 should follow by about 80 ms, the rise 405 in leg pressure curve 404. This is to allow the pressurewave induced by the apparatus of the invention to arrive at the heart at the beginning of diastole after completion of a trip taking 80 seconds.
- the curve 407 is of radial arterial pressure as measured at the wrist.
- the beginning of diastole in pressure curve 407 is signified by the so-called dicrotic notch 409 which takes place about 90 ms after the ECG reports the beginning of diastole.
- the apparatus is normally triggered by sensing the prominent QRS peak 415 of the EKG.
- FIGS. 4a and 4b an advantageous method of utilizing the above-described phenomena in phasing and control of the apparatus is set forth schematically and can be described as follows:
- a transducer-type pressure sensor 34 including a sensing bladder 35 is utilized to sense hydraulic pressure in bladder. If the pressure so sensed is less than millimeters of mercury (mm of Hg), then a pressurelevel amplifier 46 will provide an output to the andtype gate 48. if during this low-pressure signal situation, the operator closes a water fill switch 50, he will cause the and gate 48 to transmit a signal which will activate a fill pump 52 through pump control circuit 54 and simultaneously cause a multi-position, solenoid valve 56 to shift to its fill position, i.e., the position allowing water to flow from conduit 58 to conduit 60. Thereupon water will flow into the bladder 22 until a pressure of 20 mm Hg is sensed by pressure sensor 34. The signal from amplifier 46 will then drop consequently closing and-gate 48. Thereupon, fill pump 52 is deactivated and solenoid valve 56 is shifted to its off position.
- mm Hg millimeters of mercury
- Water is emptied from bladder 22 by using an analagous system whereby pressure is sensed by sensor 62.
- a signal is sent to and-gate 64. If empty switch" 66 is closed, the gate 64 will allow a signal command to actuate pump control 68 and empty pump 69 and cause solenoid valve 56 to shift to its empty position, i.e., the position allowing water to flow from conduit 60 to conduit 70 and thence back to water reservoir 72 through 74.
- the pump 69 will empty until a pressure of less than the illustrative minus 15 mm Hg is sensed. At that time the and-gate 64 will no longer sense the required signal from sensor 62, and the pump 69 will be turned off and valve 56 will return to its off position.
- the pressure within bladder 34 is maintained at its desired level by adding or removing water from the bladder system as follows:
- a displacement sensing type transducer 76 is mounted on hydraulically-actuated rod 78.
- Transducer 76 is adapted to provide an electrical signal output proportional to the linear advance of rod 78 at any given moment.
- a normalized value of the position of cylinder 78 is provided by feeding the signal from transducer 76 into a displacement level sensor 80. Thence the normalized signal is provided to a level comparator 82.
- a second imput to comparator 82 is derived as follows: An ECG signal from a patient being treated is fed into a trigger generator 84.
- the trigger generator is so selected that it recognizes and responds to the so-called QRS complex rise of the ECG signal. (This rise is identified by numeral 415 in FIG. 4).
- QRS complex rise This rise is identified by numeral 415 in FIG. 4.
- an output is triggered which is fed to a manually controlled delay 86.
- the purpose of delay 86 is to convert the original signal from first trigger generator 84 to a second timedelayed signal corresponding in real time with the beginning of cardiac diastole.
- This second signal enters a duration signal generator 88.
- Generator 88 is so selected that the signal therefrom continues for the length of time that leg pressurization (as caused by pressure in bladder 34) desired.
- This signal from generator 88 is fed to level comparator 82 through a level stroke signal generator 89.
- the signal from generator 88 is also fed to a waveform generator 90 which produces a wave whose amplitude and frequency is analogous to that desired for the leg pressurization sequence.
- a typical such wave will be trapezoidal-like in shape with a rise of 60 ms, a plateau of 250 ms, and a fall of 60 ms.
- This wave from generator 90 is fed to a wave form comparator 92 wherein it is continually compared to a signal derived from the actual bladder pressure wave as experienced by sensor 34.
- the output of comparator 92 is a socalled error signal, i.e., a signal which is indicative of the quality and strength of the difference between the desired wave signal from generator 90 and the actual wave signal from sensor 34.
- the error signal is used to control servo-valve 94 through a servo-amplifier 93 and thereby controls the supply of fluid to, and consequently the movement of, hydraulic cylinder 78.
- level comparator 82 receives two signals: one, a periodic signal from a duration signal generator 88, via strobe signal generator 89 and the other from displacement level sensor 80. Displacement level sensor compares these two signals, one indicative of the actual position of hydraulic cylinder 78 at a given time. It is the periodic, or strobe signal from duration signal generator 88, as modified by a level strobe signal generator 89, which determine when this comparison is to be made. The comparison is most usefully made at the time platen 30 is in the upper-most portion of its stroke and pressing firmly against bladder 22.
- level comparator 82 senses that the platen 30 is too high, output signal is provided to a one shot (monostable multivibrator) 96. This one shot 96 will then turn on till pump 52 and also position solenoid valve 56 for a 0.5-second fill period. The 0.5-second fill periods will continue during each cardiac period (i.e., each heartbeat) until the water volume in bladder 22 is sufficient so that the platen 30 is within an acceptable displacement range at the top of its stroke.
- the empty pump is turned on for one half second in each cardiac cycle by activation of the one shot device 98 and the empty pump 69. Water is then pumped out of the bladder until the platen achieves a desired rise during its stroke.
- a signal from an arterial pressure-sensing device 99 is fed into a dual trace oscilloscope 100 along with a signal from ECG device 102.
- the duration of an intensification of these signals is the duration of a pressure command signal as received from duration signal generator 88 and appears as intensifications of ECG trace 104 and arterial trace 106.
- Delay devices 108 and 110 of milliseconds and 80 milliseconds respectively, cause the pressure command signal to appear on both waveforms in approximately correct time relationship referenced to the actual ECG and arterial pressure.
- Delay 86 is used to bring the intensification signal into register with diastolic period as viewed on either the ECG or arterial traces, thereby simultaneously phasing the pressurization wave to the cardiac cycle.
- the operator of the apparatus can also have variable control means for changing the characteristics of the duration signal generator 88 to provide the intensified signal duration which is required for a particular patient. On the oscilloscope 101, this duration will show up as intensifications 103 of the oscilloscope traces.
- a mechanical assembly 112 comprises a base 122 on which a hydraulic cylinder 123 is mounted. Attached to cylinder 123 is a reciprocating, operating rod 124 connected, through a mechanical actuating means 114, to platen 116. Platen 116; has a rigid truncated-triangle like planar surface 117 for engagement with the bladder. The cylinder moves through a short stroke sufficient to import about a 2-inch vertical travel to platen 16.
- FIGS Sand 6 show the hydraulically-actuated platen assembly 112.
- platen assembly 112 is constructed to minimize the power requirement by utilizing a lifting means 114 whereby the product of the vertical travel of platen 116 and the resistance it meets during travel is maintained at a relatively constant value. This is to say that in the lower portion of the stroke where the reaction pressure of the bladder against the platen is relatively low, the mechanical linkage between the hydraulic cylinder and theplaten is so designed to provide a greater displacement in trade-off for pressure.
- a rigidhousing or casing 24 is used to enclose the bladder and its mechanical pressurizing means.
- This casing should be as light as is possible without compromising the rigidity thereof.
- leg casing 24 comprises a unitary upper shell 131 and a unitary lower shell 132.
- the shells are advantageously formed of plastic material and are internally reinforced with a rigid, low-density, organic-resin foam such as a polyurethane foam 134.
- a particularly advantageous aspect of the casing 24 is the quick connect and disconnect means.
- Bolt connectors 136 mounted generally between the leg rest are formed of bolts which are normally captive within upper shell 131.
- the bolts are provided with large heads which facilitate their quick connection by screwing into lower shells 132.
- Latch connectors mounted in inserts along the outer periphery of lower and outer shells comprise a pin which is so positioned on connector member 142 that when connector member 144 is moved downwardly, it will not contact pin 140 but, once lowered a lateral movement of the upper shell wil cause the pin to lock into aperture 146 of member 144. Once this latching is achieved, bolts 136 may be tightened and the operation may proceed.
- Another important aspect of the invention is tha whereby applicants have been able to combine a rela tively simple construction, having only a single fluid bladder and an upper and lower casing member, and yet achieve a device suitable for excellent pressure control.
- This result was accomplished by providing a unitary upper leg casing member 131 and a unitary lower leg casing member 132, each of which comprise two truncated semi-conical leg-receiving compartments 135. These compartments are connected by a thinner zone (see FIG. 1), which allows a single blanket-shaped bladder to be wrapped about the patients legs.
- connectors 136 connect an upper traingular brace means 150 to a lower brace means 152.
- the upper brace means is formed out of a resin-type honeycomb material 154.
- the platen has a surface area of about 100 square inches and a stroke of about 2 inches.
- This apparatus provides a displacement capacity of about 200 cubic inches and this has been found to be entirely adequate not only to meet the displacement requirements resulting from the compressability of a patients legs, but also when combined with pressure-wave monitoring and control system as disclosed above, to enable the use of materials of construction which have some limited distensibility.
- the platen and its actuating device should be selected to have a displacement capacity of at least about 100 cubic inches.
- the vertical stroke of the platen is advantageously maintained at less than about 3.5 inches to avoid design and control problems associated with excessive velocity and the mechanical and hydraulic inertice associated therewith.
- brace means comprise:
- legenclosing zones are conical in shape and adapted to dissipate stresses exerted thereon as hoop stresses, thereby resisting any substantial deflection or deformation of said zones.
- said pressurizing means has a displacement capacity of at least 100 cubic inches and comprises means for actuating said platen through a stroke length of up to about 3.5 inches.
- said mechanical displacement means is placed within said compartment formed by said casing and also comprises a platen and a power linkage forming means to impart a power stroke thereto characterized by a substantial loss of velocity of said platen as the platen rises against said bladder.
- said pressurizing means has a displacement capacity of at least 100 cubic inches and comprises means for actuating said platen through a stroke length of up to about 3.5 inches.
- said pressurizing means has a displacement capacity of at least cubic inches and comprises means for actuating said platen through a stroke length of up to about 3.5 inches.
- apparatus for applying external pressure circulatory assist action to the limbs of a patient in synchronization with the heartbeat of said patient, and wherein said assist is achieved by pressurizing a fluid-filled bladder surrounding said limbs
- said apparatus comprises a mechanical pressurizing member positioned generally between said limbs and in contact with an outside wall of said bladder and forming means to press against said bladder, said bladder adapted for reciprocal movement in contact with said bladder, said mechanical means comprising a powertransmitting linkage forming means to impart a power stroke characterized by a substantial loss of velocity of said pressurizing member as the pressure of said contact is increased in the bladder during said stroke.
- Apparatus as defined in claim 10 wherein saidbladder and mechanical pressurizing means are enclosed in a rigid casing, wherein the casing is enclosed in an envelope, and wherein a suction pump is operably connected to the interior of said envelope forming means to maintain a sub-atmospheric pressure within said envelope of between atmospheric pressure and about minus 100 mm of mercury below atmospheric pressure.
- said pressurizing means has a displacement capacity of at least 100 cubic inches and comprises means for actuating said platen through a stroke of up to about 3.5 inches.
- Apparatus as defined in claim 14 comprising a reciprocating mechanical member forming displacement means to engage said bladder and pressurize the fluid therein.
- said pressure-sensing means is an indirect sensing means comprising a displacement-sensing monitor adapted to sense the position of said mechanical pressuretransmitting device, to transmit a signal indicative of said position, and consequently indicative of said pressure in said bladder.
- G means for continually comparing said ideal and actual waveforms
- variable valve means responsive to a signal from said comparing means, to modify fluid flow to said hydraulic cylinder and thereby more nearly achieve said ideal-pressure waveform.
- Apparatus as defined in claim 19 comprising:
- Apparatus as defined in claim 20 wherein pump means is provided for adding to or subtracting fluid frornsaid bladder, said pump means being responsive to the pressure within said bladder, through a bladderpre'ssu're sensing means and a control circuit, and whereinlsaid pump is responsive to said sensing means to receive an independent command signal therefrom oneach heartbeat cycle of said patient.
- apparatus as'defined in claim 1 for applying external pressure circulatory assist action to the limbs of a patient in cyclic synchronization with a heartbeat of said patient, and wherein said assist is achieved by meansfor. pressurizing a fluid-filled bladder surrounding said lirn bs, the improvement wherein pump means is provided for adding to or subtracting the fluid from 14 said bladder, said pump means being responsive to the pressure within said bladder, through a bladderpressure sensing means and a control circuit, and wherein said pump is responsive to said sensing means to receive an independent command signal therefrom on each heartbeat cycle of said patient.
- leg-enclosing zones are conical in shape and adapted to dissipate stresses exerted thereon as hoop stresses, thereby resisting any substantial deflection or deformation of said zones.
- leg-enclosing zones are conical in shape and adapted to dissipate stresses exerted thereon as hoop stresses, thereby resisting any substantial deflection or deformation of said zones.
- Apparatus as defined in claim 26 comprising a reciprocating mechanical member forming displacement means to engage said bladder and pressurize the fluid therein.
- said pressure-sensing means is an indirect sensing means comprising a displacement-sensing monitor adapted to sense the position of said mechanical pressuretransmitting device, to transmit a signal indicative of said position, and consequently indicative of said pressure in said bladder.
- leg-enclosing zones are conical in shape and adapted to dissipate stresses exerted thereon as hoop stresses, thereby resisting any substantial deflection or deformation of said zones.
- leg-enclosing zones are conical in shape and adapted to dissipate stresses exerted thereon as hoop stresses, thereby resisting any substantial deflection or deformation of said zones.
- said pressure-sensing means is an indirect sensing means comprising a displacement-sensing monitor adapted to sense the position of said mechanical pressuretransmitting device, to transmit a signal indicative of said position, and consequently indicative of said pressure in said bladder.
- leg-enclosing zones are conical in shape and adapted to dissipate stresses exerted thereon as hoop stresses, thereby resisting any substantial deflection or deformation of said zones.
- Apparatus as defined in claim 1 for applying external pressure assist action to the limbs of a patient in cyclic synchronization with the heartbeat of said patient, wherein said assist is achieved with means for transmitting pressure through an hydraulic cylinder to said limbs through a fluid-filled bladder surrounding said limbs, the improvement wherein the apparatus includes A. an ideal pressure waveform generator means, B. actual leg pressure waveform sensing means, C. means for continually comparing said ideal and actual waveforms, and D. variable valve means, responsive to a signal from said comparing means, to modify fluid flow to said sydraulic cylinder and thereby more nearly achieve said ideal-pressure waveform. 39. Apparatus as defined in claim 38 comprising: A.
- a multi-channel oscilloscope adapted to display 1. an EKG trace, and 2. a trace derived from an arterial pressure sensor, B. means for visually displaying of the relative time duration of a pressure command signal on said traces, and C. manual means to adjust the relative timing and duration of said pressure command signal, while simultaneously achieving a visual adjustment of said signal to bring it into the desired relationship to said EKG trace.
- pump means is provided for adding to or subtracting fluid from said bladder, said pump means being responsive to the pressure within said bladder, through a bladderpressure sensing means and a control circuit, and
- said pump is responsive to said sensing means to receive an independent command signal therefrom on each heartbeat cycle of said patient.
Abstract
Description
Claims (48)
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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US19782471A | 1971-11-11 | 1971-11-11 |
Publications (1)
Publication Number | Publication Date |
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US3734087A true US3734087A (en) | 1973-05-22 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US00197824A Expired - Lifetime US3734087A (en) | 1971-11-11 | 1971-11-11 | External pressure circulatory assist |
Country Status (5)
Country | Link |
---|---|
US (1) | US3734087A (en) |
JP (5) | JPS595302B2 (en) |
CA (1) | CA1031643A (en) |
FR (1) | FR2165872B3 (en) |
IT (1) | IT975705B (en) |
Cited By (24)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3795242A (en) * | 1972-10-24 | 1974-03-05 | Medical Innovations Inc | Apparatus for applying hydraulic pulsation |
US3835845A (en) * | 1972-10-24 | 1974-09-17 | Medical Innovations Inc | Cardiac synchronization system and method |
US4388919A (en) * | 1980-11-17 | 1983-06-21 | Intermedics Cardiassist Corporation | Rapid stabilization of external cardiac pulsation |
US4991568A (en) * | 1989-02-24 | 1991-02-12 | Ching-Sung Lin | Massage device |
US5437610A (en) * | 1994-01-10 | 1995-08-01 | Spinal Cord Society | Extremity pump apparatus |
US5891065A (en) * | 1996-07-31 | 1999-04-06 | Spinal Cord Society | Mobile extremity pumping apparatus |
US20020107461A1 (en) * | 2000-11-10 | 2002-08-08 | Hui John C.K. | High efficiency external counterpulsation apparatus and method for controlling same |
US6540707B1 (en) | 1997-03-24 | 2003-04-01 | Izex Technologies, Inc. | Orthoses |
EP1305065A2 (en) * | 1999-03-05 | 2003-05-02 | Revivant Corporation | Public access cpr and aed device |
US6572621B1 (en) | 1992-05-07 | 2003-06-03 | Vasomedical, Inc. | High efficiency external counterpulsation apparatus and method for controlling same |
US6620116B2 (en) | 2000-12-08 | 2003-09-16 | Michael P. Lewis | External counterpulsation unit |
US20030233118A1 (en) * | 2002-06-13 | 2003-12-18 | Hui John C. K. | Method for treating congestive heart failure using external counterpulsation |
US20050043660A1 (en) * | 2003-03-31 | 2005-02-24 | Izex Technologies, Inc. | Orthoses |
US6872187B1 (en) | 1998-09-01 | 2005-03-29 | Izex Technologies, Inc. | Orthoses for joint rehabilitation |
US20050070755A1 (en) * | 1993-05-06 | 2005-03-31 | Zhensheng Zheng | High efficiency external counterpulsation method |
US20050075531A1 (en) * | 2003-10-07 | 2005-04-07 | Loeb Marvin P. | Devices and methods for non-invasively improving blood circulation |
US20060058717A1 (en) * | 2004-09-14 | 2006-03-16 | Hui John C K | External counterpulsation device having a curvilinear bed |
US7048702B2 (en) | 2002-06-13 | 2006-05-23 | Vasomedical, Inc. | External counterpulsation and method for minimizing end diastolic pressure |
US20060129050A1 (en) * | 2004-11-15 | 2006-06-15 | Martinson James B | Instrumented implantable stents, vascular grafts and other medical devices |
US20060271112A1 (en) * | 2004-11-15 | 2006-11-30 | Martinson James B | Instrumented orthopedic and other medical implants |
US20070272250A1 (en) * | 2006-05-24 | 2007-11-29 | Michael Paul Lewis | External pulsation treatment apparatus |
US20080319248A1 (en) * | 2007-06-20 | 2008-12-25 | Michael Paul Lewis | Hydraulically Actuated External Pulsation Treatment Apparatus |
US20100121160A1 (en) * | 1999-06-23 | 2010-05-13 | Izex Technologies, Inc. | Remote psychological evaluation |
WO2016057450A1 (en) * | 2014-10-07 | 2016-04-14 | Shakam LLC | Compression therapy device having mechanical advantage |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3242814A1 (en) * | 1982-11-19 | 1984-05-24 | Siemens AG, 1000 Berlin und 8000 München | METHOD AND RESPIRATOR FOR BREATHING A PATIENT IN THE HEART RHYMUS AND FOR SUPPORTING THE BLOOD CIRCULATION |
JPS59106763A (en) * | 1982-12-08 | 1984-06-20 | Nichias Corp | Gland packing |
JPS62136343A (en) * | 1985-12-06 | 1987-06-19 | Toyoda Mach Works Ltd | Trouble prediction device for feeding device |
-
1971
- 1971-11-11 US US00197824A patent/US3734087A/en not_active Expired - Lifetime
-
1972
- 1972-10-10 CA CA156,230A patent/CA1031643A/en not_active Expired
- 1972-11-10 JP JP47112810A patent/JPS595302B2/en not_active Expired
- 1972-11-10 IT IT70547/72A patent/IT975705B/en active
- 1972-11-13 FR FR7240238A patent/FR2165872B3/fr not_active Expired
-
1979
- 1979-11-09 JP JP54145307A patent/JPS5822221B2/en not_active Expired
- 1979-11-09 JP JP54145308A patent/JPS595303B2/en not_active Expired
- 1979-11-09 JP JP14530679A patent/JPS5576655A/en active Pending
- 1979-11-09 JP JP54145309A patent/JPS596662B2/en not_active Expired
Cited By (47)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3835845A (en) * | 1972-10-24 | 1974-09-17 | Medical Innovations Inc | Cardiac synchronization system and method |
US3795242A (en) * | 1972-10-24 | 1974-03-05 | Medical Innovations Inc | Apparatus for applying hydraulic pulsation |
US4388919A (en) * | 1980-11-17 | 1983-06-21 | Intermedics Cardiassist Corporation | Rapid stabilization of external cardiac pulsation |
US4991568A (en) * | 1989-02-24 | 1991-02-12 | Ching-Sung Lin | Massage device |
US6572621B1 (en) | 1992-05-07 | 2003-06-03 | Vasomedical, Inc. | High efficiency external counterpulsation apparatus and method for controlling same |
US20050070755A1 (en) * | 1993-05-06 | 2005-03-31 | Zhensheng Zheng | High efficiency external counterpulsation method |
US5437610A (en) * | 1994-01-10 | 1995-08-01 | Spinal Cord Society | Extremity pump apparatus |
US5891065A (en) * | 1996-07-31 | 1999-04-06 | Spinal Cord Society | Mobile extremity pumping apparatus |
US6540707B1 (en) | 1997-03-24 | 2003-04-01 | Izex Technologies, Inc. | Orthoses |
US9230057B2 (en) | 1998-09-01 | 2016-01-05 | Izex Technologies, Inc. | Remote monitoring of a patient |
US6872187B1 (en) | 1998-09-01 | 2005-03-29 | Izex Technologies, Inc. | Orthoses for joint rehabilitation |
US8678979B2 (en) | 1998-09-01 | 2014-03-25 | Izex Technologies, Inc. | Remote monitoring of a patient |
EP1305065A2 (en) * | 1999-03-05 | 2003-05-02 | Revivant Corporation | Public access cpr and aed device |
US20040162589A1 (en) * | 1999-03-05 | 2004-08-19 | Revivant Corporation | Public access CPR and AED device |
EP1305065A4 (en) * | 1999-03-05 | 2004-10-06 | Revivant Corp | Public access cpr and aed device |
US9415232B2 (en) | 1999-03-05 | 2016-08-16 | Zoll Circulation, Inc. | Public access CPR and AED device |
US20070055311A1 (en) * | 1999-03-05 | 2007-03-08 | Zoll Circulation, Inc. | Public access CPR and AED device |
US7666154B2 (en) | 1999-03-05 | 2010-02-23 | Zoll Circulation, Inc. | Public access CPR and AED device with varying levels of access |
US8790258B2 (en) | 1999-06-23 | 2014-07-29 | Izex Technologies, Inc. | Remote psychological evaluation |
US20100121160A1 (en) * | 1999-06-23 | 2010-05-13 | Izex Technologies, Inc. | Remote psychological evaluation |
US20050131456A1 (en) * | 2000-11-10 | 2005-06-16 | Hui John C.K. | High efficiency external counterpulsation apparatus and method for controlling same |
US6962599B2 (en) | 2000-11-10 | 2005-11-08 | Vasomedical, Inc. | High efficiency external counterpulsation apparatus and method for controlling same |
US6589267B1 (en) | 2000-11-10 | 2003-07-08 | Vasomedical, Inc. | High efficiency external counterpulsation apparatus and method for controlling same |
US20020107461A1 (en) * | 2000-11-10 | 2002-08-08 | Hui John C.K. | High efficiency external counterpulsation apparatus and method for controlling same |
US7314478B2 (en) | 2000-11-10 | 2008-01-01 | Vasomedical, Inc. | High efficiency external counterpulsation apparatus and method for controlling same |
US6620116B2 (en) | 2000-12-08 | 2003-09-16 | Michael P. Lewis | External counterpulsation unit |
US7048702B2 (en) | 2002-06-13 | 2006-05-23 | Vasomedical, Inc. | External counterpulsation and method for minimizing end diastolic pressure |
US20030233118A1 (en) * | 2002-06-13 | 2003-12-18 | Hui John C. K. | Method for treating congestive heart failure using external counterpulsation |
US20050043660A1 (en) * | 2003-03-31 | 2005-02-24 | Izex Technologies, Inc. | Orthoses |
USRE42958E1 (en) * | 2003-10-07 | 2011-11-22 | Cardiomedics, Inc. | Devices and methods for non-invasively improving blood circulation |
US20050075531A1 (en) * | 2003-10-07 | 2005-04-07 | Loeb Marvin P. | Devices and methods for non-invasively improving blood circulation |
US7244225B2 (en) | 2003-10-07 | 2007-07-17 | Cardiomedics, Inc. | Devices and methods for non-invasively improving blood circulation |
US20060058717A1 (en) * | 2004-09-14 | 2006-03-16 | Hui John C K | External counterpulsation device having a curvilinear bed |
US20060058716A1 (en) * | 2004-09-14 | 2006-03-16 | Hui John C K | Unitary external counterpulsation device |
US20060058715A1 (en) * | 2004-09-14 | 2006-03-16 | Hui John C | External counterpulsation device with multiple processors |
US8491572B2 (en) | 2004-11-15 | 2013-07-23 | Izex Technologies, Inc. | Instrumented orthopedic and other medical implants |
US8308794B2 (en) | 2004-11-15 | 2012-11-13 | IZEK Technologies, Inc. | Instrumented implantable stents, vascular grafts and other medical devices |
US20060271112A1 (en) * | 2004-11-15 | 2006-11-30 | Martinson James B | Instrumented orthopedic and other medical implants |
US8740879B2 (en) | 2004-11-15 | 2014-06-03 | Izex Technologies, Inc. | Instrumented orthopedic and other medical implants |
US8784475B2 (en) | 2004-11-15 | 2014-07-22 | Izex Technologies, Inc. | Instrumented implantable stents, vascular grafts and other medical devices |
US20060129050A1 (en) * | 2004-11-15 | 2006-06-15 | Martinson James B | Instrumented implantable stents, vascular grafts and other medical devices |
US7981066B2 (en) | 2006-05-24 | 2011-07-19 | Michael Paul Lewis | External pulsation treatment apparatus |
US20070272250A1 (en) * | 2006-05-24 | 2007-11-29 | Michael Paul Lewis | External pulsation treatment apparatus |
US20080319248A1 (en) * | 2007-06-20 | 2008-12-25 | Michael Paul Lewis | Hydraulically Actuated External Pulsation Treatment Apparatus |
US8114037B2 (en) | 2007-06-20 | 2012-02-14 | Michael Paul Lewis | Hydraulically actuated external pulsation treatment apparatus |
WO2016057450A1 (en) * | 2014-10-07 | 2016-04-14 | Shakam LLC | Compression therapy device having mechanical advantage |
US9770385B2 (en) | 2014-10-07 | 2017-09-26 | Shakam LLC | Compression therapy device having mechanical advantage |
Also Published As
Publication number | Publication date |
---|---|
JPS5576657A (en) | 1980-06-09 |
JPS595303B2 (en) | 1984-02-03 |
JPS5822221B2 (en) | 1983-05-07 |
JPS596662B2 (en) | 1984-02-14 |
JPS595302B2 (en) | 1984-02-03 |
FR2165872A1 (en) | 1973-08-10 |
JPS4862282A (en) | 1973-08-30 |
IT975705B (en) | 1974-08-10 |
JPS5576655A (en) | 1980-06-09 |
JPS5576656A (en) | 1980-06-09 |
FR2165872B3 (en) | 1975-11-28 |
JPS5586466A (en) | 1980-06-30 |
CA1031643A (en) | 1978-05-23 |
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