WO1987002894A2 - Dispositif externe d'assistance cardiaque pulsatile - Google Patents

Dispositif externe d'assistance cardiaque pulsatile Download PDF

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Publication number
WO1987002894A2
WO1987002894A2 PCT/US1986/002415 US8602415W WO8702894A2 WO 1987002894 A2 WO1987002894 A2 WO 1987002894A2 US 8602415 W US8602415 W US 8602415W WO 8702894 A2 WO8702894 A2 WO 8702894A2
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WO
WIPO (PCT)
Prior art keywords
blood
heart
patient
pulsatile
outside
Prior art date
Application number
PCT/US1986/002415
Other languages
English (en)
Other versions
WO1987002894A3 (fr
Inventor
Nicholas Accisano
Robert I. Bernstein
Shurman Shonk
James Wilson
Stern D. Shurygailo
Bradford Paskewitz
Stephen H. Hine
Daniel Flanigan
Original Assignee
Electro-Catheter Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Electro-Catheter Corporation filed Critical Electro-Catheter Corporation
Priority to GB8712167A priority Critical patent/GB2196854B/en
Publication of WO1987002894A2 publication Critical patent/WO1987002894A2/fr
Priority to SE8702673A priority patent/SE8702673D0/xx
Publication of WO1987002894A3 publication Critical patent/WO1987002894A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/104—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
    • A61M60/109—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems
    • A61M60/113—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems in other functional devices, e.g. dialysers or heart-lung machines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/247—Positive displacement blood pumps
    • A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
    • A61M60/279—Peristaltic pumps, e.g. roller pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
    • A61M60/36—Medical purposes thereof other than the enhancement of the cardiac output for specific blood treatment; for specific therapy
    • A61M60/37—Haemodialysis, haemofiltration or diafiltration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
    • A61M60/36—Medical purposes thereof other than the enhancement of the cardiac output for specific blood treatment; for specific therapy
    • A61M60/38—Blood oxygenation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/424—Details relating to driving for positive displacement blood pumps
    • A61M60/427—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/562—Electronic control means, e.g. for feedback regulation for making blood flow pulsatile in blood pumps that do not intrinsically create pulsatile flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3303—Using a biosensor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/89—Valves
    • A61M60/892—Active valves, i.e. actuated by an external force
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/89—Valves
    • A61M60/894—Passive valves, i.e. valves actuated by the blood

Definitions

  • This invention relates to new and useful improvements in external pulsatile cardiac assist devices and more particularly seeks to provide a unitary system that can be readily available for temporary or emergency procedures in either a surgical or percutaneous mode.
  • the unit is external to the patient. This avoids the use of miniaturization of design and permits more efficient procedures, including filtration of the blood, development of pulsatile drive, automatic control of and measurement of blood flow and easy visibility of and access to all the working parts.
  • the primary field of this invention is medicine as it relates to assisting or taking the place of cardiac output of a weakened or diseased heart and particularly during heart surgery, trauma periods accompanying infarction or other heart damage, various other procedures, such as angioplasty, or waiting for a suitably matched transplant.
  • electronics is a secondary field utilized to communicate the patient's condition and to control the parameters of the cardiac assistance.
  • the invention consists of a method and device for pulsatilely assisting or replacing of the natural heart beat during emergency periods with the only patient connection being cannulae to the venous and arterial sides of the circulatory system.
  • This permits greater efficiency in maintaining a natural type of pulsatile pressure, filtration of the blood supply, more rapid and appropriate response to patient's condition and automatic control of the blood flow in response to sensing the electrocardiogram, pressure waveform, and actual blood flow of the patient.
  • the unit is readily adaptable to be mounted on a portable hospital cart and permits quick replacement of a malfunctioning unit without jeopardy to the patient.
  • means are provided to automatically sense that event, activate an alarm, and reduce the pumping pressure to avoid harm to the patient and to various components of the pumping system.
  • the unit automatically augments only alternate beats and beats possessing a predefined regularity of rhythm by utilization of a specific settable refractory period to thus maintain better stroke efficiency.
  • the microprocessor will after a specific settable period of time, cause the pump to deliver pulses of blood at a specific settable rate and with a volume per stroke that will automatically deliver the quantity of blood per unit time that the perfusionist or physician has set on the unit's front panel.
  • the microprocessor instantly responds and returns the unit to the mode of operation in which the pulsatile delivery of blood is synchronized with the patient's heart beat so as to augment it at the end of cardiac systole. This is the Escape operation.
  • the balloon and pulsatile unit is driven by a hydraulic system containing a solution of sterile isotonic saline so that possible leaks cause no harm to the patient. Furthermore, the hydraulic system employs a sealed bellows so that there is no leakage as might occur around a piston drive.
  • the unit is entirely controlled by a microprocessor with a software program which responds to measuring the and EKG.
  • the augmentative pulsatile delivery timing and flow rate may be adjusted by the perfusionist or physician who observes the screen.
  • the EKG is measured from the patient's skin directly or through an available hospital monitor.
  • the electronic circuitry filters the EKG signal to recognize the R-wave and to ignore pacing stimuli. Multiple successive R-waves are averaged continually.
  • the device when synchronized with the heart beat, is generally adjusted to augment regular flow by starting its pulsatile delivery on the descending T- wave and ending just as the next systole is about to commence, thereby providing better flow during cardiac diastole.
  • FIG. 1 is a diagrammatic functional view of the components of this invention and a patient
  • Fig. 2 is a perspective view of the hospital cart on which the unit is mounted;
  • Fig. 3 is a prior art human cardiac cycle chart to which has been added an aortic pressure line resulting from this invention
  • Fig. 4 is a diagrammatic view of the pulsating device
  • Fig. 5 is a perspective view of a valve within the pulsating device
  • Fig. 6 is a diagrammatic view of a portion of the servomechanism
  • Fig. 7 is a block diagram of the servomechanism
  • Fig. 8 is a cross section of the mechanical drive assembly including the bellows
  • Fig. 9 is a cross section of the diaphragm housing
  • Fig. 10 is a diagrammatic view of the electronic control and electrical system
  • venous blood is removed from patient 16 and returned to the arterial side in either a surgical or percutaneous mode.
  • the surgical mode is similar to open heart surgery where the heart is exposed through an open chest. Blood is removed through a cannula in the vena cava by gravity or by suction and passed to the oxygenator 17.
  • a cannula is inserted in the right femoral vein and passed to the right or left atrium to take blood. If taken from the left atrium, the oxygenator may be excluded or bypassed, as the lungs will be functioning.
  • a roller pump 18 with approximately 80-100 mm Hg suction is used to remove the blood in this mode.
  • the blood is passed to (or bypasses) oxygenator 17 and then goes to (or bypasses) pulsatile pump chamber 19 which is activated by bellows 20 from mechanical drive 21 optionally through isolation diaphragm 22.
  • the blood then passes through (or bypasses) blood filter 23 and goes back into the arterial side.
  • the blood return is to the aorta.
  • the percutaneous mode it is returned to the left or right femoral artery or the cannula may be extended past the bifurcation into the abdominal aorta.
  • a portable hospital cart 24 whereon the unit is mounted with a viewing screen 26 and operating controls is shown in Fig. 2.
  • an emergency battery is provided for automatic change-over, the mode being shown at lights 27 and 28.
  • the extent of battery charge is shown at 29 and once the unit returns to AC, the batteries will automatically recharge. Batteries have sufficient charge to provide a 90 minute minimum operation.
  • the screen can display EKG and blood pressure waveforms, and pump strokes, which are used as a guide in setting optimal timing of the pulsatile blood delivery. This delivery may be displayed by intensifying the corresponding portion of the EKG line on the screen.
  • Light and/or bell alarms 31 are shown for EKG pre-set ranges, occlusion, battery charge and the blood flow meter. Loudness of alarms may be increased by rotary switch 32.
  • the unit may be set by switch 36 on panel 33 to synchronize to the natural heart rate or to replace the normal heart by switch 35 on panel 34.
  • the delivery strokes of the pump may be set for alternate beats of the heart at 37, which is particularly useful in weaning a heart from the machine.
  • the start and duration of the delivered stroke can be varied at switches 38, 39.
  • the mean flow in volume/time is displayed at 41 and varied by control 43. Transfusions can be made during zero flow in 20 ml does at 42 in 1 to 5 sequences.
  • Fig. 3 is a prior art textbook chart of the human cardiac cycle except for the added dot-dash supplemental aortic pressure line 44 that shows the effect of the present pulsatile unit during diastole in the percutaneous mode, i.e.
  • the aortic pressure is increased during diastole. This creates higher perfusion pressure throughout the body's vascular system at a time when arterial blood is needed and particularly to the coronary arteries at a time when collateral circulation is needed to limit the final size of the infarct.
  • a pulsatile blood pressure is being applied to the entire vascular tree instead of the constant pressure provided heretofore by heart-lung machines having roller pumps. Pulsatile pressure is natural to the vascular system and causes better perfusion and less resistance.
  • the pulsatile pump chamber 19 is shown in Fig. 4, having structural components of polycarbonate or other rigid medical grade material and flexible components of silicone, silasti ⁇ and/or urethane or other very flexible medical grade material.
  • Inlet 45 and outlet 46 blood lines are connected to the primary blood flow line.
  • One-way tricuspid inlet 47 and outlet 48 valves are placed at each end of bladder 49 which is supported within and spaced from rigid cylinder 51.
  • the cylinder is provided with a hydraulic fluid inlet 52 and a stopcock 53.
  • a hydraulic fluid inlet 52 is connected optionally to isolation diaphragm 22 shown in Fig. 9 or directly to bellows 20 (Fig. 8) housing.
  • the housing 57 is fastened together incorporating a silicone sheet 58 as a diaphragm and gasket. Openings on both sides of the diaphragm would allow the hydraulic system to be quickly filled and stopcocks 59 allows air to be removed.
  • the diaphragm housing is provided on both sides with a hydraulic line fitting 61, 61, one leading to upstream chamber 62 and the other to downstream chamber 63.
  • the motor generator combination is mounted adjacent to the bellows 20. Each utilizes a separate armature winding with the tachometer generator winding being temperature compensated. Commutation to both of the armatures is accomplished via metal graphite brushes interfaced with polished copper segments. Shafts are supported in two sets of shielded ball bearings.
  • the nominal output of the motor is 1/2 hp with a maximum speed of 4000 rpm and a maximum torque rating of 160 oz - in.
  • the generator output has a voltage gradient of 21 volts per 1000 rpm.
  • the power amplifier is a linear amplification system that functions as a controllable power source for the DC motor.
  • This unit interfaces with the controller, which produces an approximation of an analog voltage that is proportional to the desired motor velocity in amplitude and direction.
  • the circuitry utilizes all solid state components and incorporates protection which guards against overloading either the amplifier or the motor.
  • the peak current available at the motor terminals is 22 amps and the maximum voltage is 40 volts positive and negative. Peak power output is limited to 530 watts.
  • the purpose of the mechanical drive is the conversion of the signals from he controller into corresponding hydraulic displacements.
  • the servosystem accepts signals from the controller in the form of voltage waveforms and converts them into angular displacements at the motor shaft.
  • the major components of this system include a permanent magnet motor 66 with a close coupled tachometer generator 67, a position sensor, e.g. a feedback potentiometer or equivalent 68; and a power amplifier. These are arranged as a servomechanism with the tachometer generator forming the inner loop effecting output-rate damping and the potentiometer forming the outer loop with position feedback.
  • the rotational motion of the servomotor is translated into rectilinear motion at the bellows assembly with the use of an oscillating crank 69.
  • This crank is an integral part of the gear segment with an effective linear displacement of two inches produced by a radius of two inches swinging through an angle of 60 degrees.
  • the output of the crank is taken through an arm via a trunnion 72 to a linear bearing 73 which limits the motion to a straight line.
  • the arm pivots with the aid of two 1/2 diameter needle bearing 74 that ride on hardened pins 76 at each end.
  • the lower pin is held in the gear segment and the upper pin is tied to the 1/2 inch shaft of the linear bearing via a yoke.
  • the linear bearing consisting of two recirculating ball bearings retained in a housing, guides the hardened shaft 77 to deliver the straight line mechanical displacement to the bellows.
  • a gear set is utilized. This set consists of a segment with 38 teeth, on a 12 inch pitch circle of 16 diametral pitch in mesh with a 14 tooth pinion coincident with the motor shaft.
  • the drive ratio thus produced gives a torque multiplication of 12 to 1.
  • the gear segment is locked with a set screw to a 7/8 inch diameter shaft that is supported in two needle bearings and is trapped between two solid thrust washers to constrain its motion.
  • the pinion is locked onto the motor shaft, deriving support from the integral bearings in the housing along with a single needle bearing acting as a pilot.
  • the mechanical motion of the gear segment is limited by solid stops at each end of the travel to a maximum of 72 degrees to prevent damage to the mechanism.
  • Position is obtained from the rotary potentiometer 68 driven by the gear segment.
  • the potentiometer is linear over a 350 degree rotation through its 1000 ohm element.
  • the element is energized from the negative 10 volt regulated supply on the servo amplifier.
  • the wiper divides this supply voltage with respect to ground and returns it to the auxiliary input of the amplifier to close the position portion of the control loop.
  • the 1/4 inch shaft of the potentiometer carries a 36 tooth 64 pitch spur gear pinion locked in place with a set screw.
  • This gear is in mesh with a 180 tooth 64 pitch bull gear attached to the gear segment and constrained to follow the oscillations about the 7/8 inch diameter shaft with a 1/8 inch diameter diamond shaped pin axially penetrating the 1/8 inch bull gear and pressed into an aluminum spacer that is locked to the shaft.
  • the gear set produces a step up ratio of 1 to 5 and therefore produces an input to the potentiometer of 300 degrees for 60 degrees of rotation on the larger gear segment. This results in a one-to-one correspondence between voltage and position for a voltage between the ground reference and 10 volts and the angular position of the gear segment and its attached crank.
  • the pitch line of the potentiometer gear set closely approximates the thrust line of the crank arm to optimize the ratio of resolved motion to actual output by minimizing the effect of backlash in the mesh of the gears.
  • the potentiometer housing style is a servo mount that is locked to the transmission via three servo feet with screws. Fine adjustment of the position offset in the control loop is obtained by rotary adjustments to this servo mount. Coarse adjustments to the offset are made by changing the relative position of the teeth in mesh with the gear set.
  • Mechanical motion is transformed into hydraulic displacement via the bellows 20, which consists of a urethane tube having convolutions 64. These are reinforced with wire rings to limit the reaction of the tube to flexing between the adjacent convolutions on both the push and pull strokes.
  • a set of parallel rods lies axially along the outside periphery of the convolutions to constrain the tube in line with the linear bearing.
  • the tube end closest to the bearing is capped with a blind plug that is attached to the mechanical output. Sealing against fluid loss is maintained by an o-ring in the plug.
  • the block that surrounds the output end serves to transmit all the thrust from the bellows motion into the drive frame thereby allowing only hydraulic displacement to be transmitted into the output tube 78.
  • the hydraulic displacements produced by the bellows are fed into diaphragm housing 22 that provides a sterile barrier between pump chamber assembly 19 and the mechanical drive 21.
  • Each of the priming ports has a stopcock 59 that is used to introduce the fluid and extract air on each side of the assembly to balance the position of the diaphragm. Once the system is primed with fluid and balanced, the stopcocks are closed to maintain the condition of the system during operation.
  • the entire diaphragm assembly is sterilized prior to use in the system to assure that the hydraulic medium in the pump chamber assembly remains sterile.
  • the purpose of the pump chamber assembly is to convert the hydraulic displacement from the drive unit into pulsatile blood flow to the patient.
  • the hydraulic portion consists of chamber 55 in Fig. 4, formed by a rigid plastic tube that is capped on each end, and supports a concentric silicone rubber tube held within.
  • the bladder 49 forms an interface between the hydraulic medium and the extracorporeal blood path.
  • the atraumatic trileaflet check valves 56 permit blood flow only in the forward direction.
  • the inlet valve With hydraulic fluid flowing out of the chamber 55, the inlet valve is opened as the outlet valve is closed causing blood to enter the bladder. With hydraulic fluid flowing into the chamber 55 assembly, the outlet valve is opened as the inlet valve is closed, causing blood to exit the bladder and advance towards the patient 16.
  • the function of the electronics is to accept inputs at the user and EKG interfaces and send a signal to the motor interface to effect the required pump stroke profile. Computation capability is provided by a Z80 microprocessor.
  • the microprocessor polls the input switch and knob positions. It interprets them either directly from their binary state, or a digitization of their position. Flow through the blood circuit is measured and polled by the microprocessor. Flow and rate values are indicated on 7-segment LED displays to provide visual feedback for the user.
  • the EKG interface provides the capability of accepting either a preamplified EKG signal from a monitor or alternatively it can read EKG potentials directly from the skin. A medical-grade isolation amplifier with leakage current less than 10 microamperes protects against patient shock hazard. The EKG signal is processed then fed into an interrupt line to the microprocessor.
  • the microprocessor employs a real-time clock to determine the heart beat rate and computes effective heart rate as the moving average of a plurality of beats (for example 4) .
  • the range of both the start and duration controls is based on percentages of the time between beats indicated by the effective heart rate.
  • ALT is defined as the ratio of the number of natural heart beats to the number of delivered strokes.
  • the ALT ratio is set by pushing the appropriate selector button on the front panel. ALT ratios other than 1:1 are used to wean a patient off the pump when the heart recuperates.
  • the microprocessor also simultaneously generates an output waveform which, after amplification, controls the motor; which in turn drives the pump.
  • Fig. 7 shows the servomechanism block diagram which provides accurate tracking of pump position to the position signal.
  • FIG. 10 shows the details of the electronic block diagram with appropriate notations having been made on the diagram.
  • the herein described system produces truly pulsatile blood flow which can either be synchronized with a beating heart or assume the entire circulatory burden in case of asystole.
  • the pump delivery is timed to provide cardiac augmentation throughout the diastolic period. It can be adjusted continuously to assume between zero and 100% of the pumping burden, and thereby provide any desired amount of afterload reduction.
  • the pumping rate can be set between 40 and 120 beats per minute.
  • a microprocessor causes the pump to adjust automatically to synchronous or asynchronous operation in accordance with the heart's requirements, although the automatic operation can be superseded by manual controls when desired.
  • the pump can deliver eight liters per minute in the anticipated range of physiological parameters.
  • the blood propelling element is a sac which is alternatively compressed and expanded to produce the appropriate stroke volume.
  • a tricuspid check valve at each end of the sac forces the blood to move in the proper direction.
  • the assemblage of sac and check valves have been designed to avoid blood trauma, and tests have shown it to be less hemolytic than conventional roller pumps operating in the usual continuous flow mode.
  • the compression and expansion of the sac is caused by a sealed hydraulic system utilizing, sterile isotonic saline as the hydraulic fluid.
  • the hydraulic system provides positive displacement and accurate control, in contrast to pneumatic systems in which precise control is prevented because of the compressibility of the gas.
  • the microprocessor is contained herein as the controller 81 in Fig. 10 and has been programmed to accept all the parameters noted in the figure, the specific program being set forth hereinafter.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Mechanical Engineering (AREA)
  • Pulmonology (AREA)
  • Urology & Nephrology (AREA)
  • Emergency Medicine (AREA)
  • Vascular Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

Le dispositif ci-décrit est destiné à retirer le sang veineux de la veine cave ou du coeur jusqu'à un point situé à l'extérieur du patient, à appliquer une pression pulsatile à l'extérieur du corps du patient, en plus d'une oxygénation et d'une filtration si nécessaire, et à retourner le sang pulsé dans l'aorte, afin d'augmenter la pression et la durée de la diastole. En mode chirurgical, le coeur est complètement évité par le sang recueilli et réintroduit près du coeur bloqué. En mode percutané, l'entrée se fait par les canules dans l'artère et la veine fémorale, la canule veineuse étant étendue jusque dans l'oreillette droite ou de préférence l'oreillette gauche et la canule artérielle étant étendue jusque dans l'aorte.
PCT/US1986/002415 1985-11-12 1986-11-07 Dispositif externe d'assistance cardiaque pulsatile WO1987002894A2 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
GB8712167A GB2196854B (en) 1985-11-12 1986-11-07 External pulsatile cardiac assist device
SE8702673A SE8702673D0 (sv) 1985-11-12 1987-06-29 Extern pulsationsanordning for hjertassistans

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US79688785A 1985-11-12 1985-11-12
US796,887 1985-11-12

Publications (2)

Publication Number Publication Date
WO1987002894A2 true WO1987002894A2 (fr) 1987-05-21
WO1987002894A3 WO1987002894A3 (fr) 1987-10-08

Family

ID=25169315

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PCT/US1986/002415 WO1987002894A2 (fr) 1985-11-12 1986-11-07 Dispositif externe d'assistance cardiaque pulsatile

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EP (1) EP0246302A1 (fr)
JP (1) JPS63501929A (fr)
DE (1) DE3690585T1 (fr)
GB (1) GB2196854B (fr)
IL (1) IL80537A0 (fr)
SE (1) SE8702673D0 (fr)
WO (1) WO1987002894A2 (fr)

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997040865A1 (fr) * 1996-04-30 1997-11-06 Medtronic, Inc. Generation de pression pulsatoire dans un coeur-poumon artificiel
US6217546B1 (en) 1997-05-19 2001-04-17 United States Surgical Corporation Catheter system
WO2002005871A2 (fr) 2000-07-18 2002-01-24 Wang Dai Yuan Dispositif et procede d'assistance cardiaque
WO2004103441A1 (fr) * 2003-05-22 2004-12-02 Institut Lasernoy Phiziki So Ran Procede de pontage cardiaque, appareil permettant sa mise en oeuvre, et canule vasculaire
WO2013152309A1 (fr) 2012-04-06 2013-10-10 Heartware, Inc. Dispositif d'assistance pulmonaire ambulatoire équipé d'une pompe à sang implantée et d'un oxygénateur
US10722631B2 (en) 2018-02-01 2020-07-28 Shifamed Holdings, Llc Intravascular blood pumps and methods of use and manufacture
US10744255B2 (en) 2014-07-22 2020-08-18 Heartware, Inc. Cardiac support system and methods
US11185677B2 (en) 2017-06-07 2021-11-30 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
CN115068807A (zh) * 2022-05-31 2022-09-20 绍兴梅奥心磁医疗科技有限公司 脉冲式体外肺膜动力泵及体外膜肺氧合装置
US11511103B2 (en) 2017-11-13 2022-11-29 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
US11654275B2 (en) 2019-07-22 2023-05-23 Shifamed Holdings, Llc Intravascular blood pumps with struts and methods of use and manufacture
US11724089B2 (en) 2019-09-25 2023-08-15 Shifamed Holdings, Llc Intravascular blood pump systems and methods of use and control thereof
EP2832383B1 (fr) * 2013-07-29 2023-08-30 Xenios AG Agencement doté d'une pompe à sang et commande de pompe
US11964145B2 (en) 2019-07-12 2024-04-23 Shifamed Holdings, Llc Intravascular blood pumps and methods of manufacture and use

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4221379A1 (de) * 1992-07-02 1994-01-05 Flechsig Rudolf Prof Dipl Ing Pumpkammer für medizinische Zwecke
GB2467133A (en) * 2009-01-22 2010-07-28 Papworth Hospital Nhs Foundati Apparatus for providing short-term cardiac support

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FR1451277A (fr) * 1965-03-31 1966-01-07 Procédé et appareils pour établir les circulations extra-corporelles, en phase avec la révolution cardiaque, par dérivation systolique de la pompe
US3604016A (en) * 1969-02-06 1971-09-14 Thermo Electron Corp Multiple function blood coupler
FR2342078A1 (fr) * 1976-02-27 1977-09-23 Datascope Corp Appareil facilitant et ameliorant la circulation sanguine
US4274408A (en) * 1979-03-26 1981-06-23 Beatrice Nimrod Method for guide-wire placement and novel syringe therefor
EP0075606A1 (fr) * 1981-09-25 1983-04-06 Tsunekazu Hino Système pour la circulation extracorporelle du sang
EP0139548A1 (fr) * 1983-08-08 1985-05-02 Universite Du Droit Et De La Sante De Lille Dispositif de régulation d'une pompe

Patent Citations (6)

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Publication number Priority date Publication date Assignee Title
FR1451277A (fr) * 1965-03-31 1966-01-07 Procédé et appareils pour établir les circulations extra-corporelles, en phase avec la révolution cardiaque, par dérivation systolique de la pompe
US3604016A (en) * 1969-02-06 1971-09-14 Thermo Electron Corp Multiple function blood coupler
FR2342078A1 (fr) * 1976-02-27 1977-09-23 Datascope Corp Appareil facilitant et ameliorant la circulation sanguine
US4274408A (en) * 1979-03-26 1981-06-23 Beatrice Nimrod Method for guide-wire placement and novel syringe therefor
EP0075606A1 (fr) * 1981-09-25 1983-04-06 Tsunekazu Hino Système pour la circulation extracorporelle du sang
EP0139548A1 (fr) * 1983-08-08 1985-05-02 Universite Du Droit Et De La Sante De Lille Dispositif de régulation d'une pompe

Cited By (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997040865A1 (fr) * 1996-04-30 1997-11-06 Medtronic, Inc. Generation de pression pulsatoire dans un coeur-poumon artificiel
US6547753B1 (en) * 1996-04-30 2003-04-15 Medtronic, Inc. Pulsatile flow generation in heart-lung machines
US6217546B1 (en) 1997-05-19 2001-04-17 United States Surgical Corporation Catheter system
WO2002005871A2 (fr) 2000-07-18 2002-01-24 Wang Dai Yuan Dispositif et procede d'assistance cardiaque
EP1303333A2 (fr) * 2000-07-18 2003-04-23 Dai-Yuan Wang Dispositif et procede d'assistance cardiaque
EP1303333A4 (fr) * 2000-07-18 2006-12-20 Dai-Yuan Wang Dispositif et procede d'assistance cardiaque
US7410459B2 (en) 2000-07-18 2008-08-12 Dai-Yuan Wang Cardiac support device and method
WO2004103441A1 (fr) * 2003-05-22 2004-12-02 Institut Lasernoy Phiziki So Ran Procede de pontage cardiaque, appareil permettant sa mise en oeuvre, et canule vasculaire
US20170312416A1 (en) * 2012-04-06 2017-11-02 Heartware, Inc. Ambulatory lung assist device with implanted blood pump and oxygenator
US9011311B2 (en) 2012-04-06 2015-04-21 Heartware, Inc. Ambulatory lung assist device with implanted blood pump and oxygenator
EP2833939A4 (fr) * 2012-04-06 2015-11-25 Heartware Inc Dispositif d'assistance pulmonaire ambulatoire équipé d'une pompe à sang implantée et d'un oxygénateur
US9278169B2 (en) 2012-04-06 2016-03-08 Heartware, Inc. Ambulatory lung assist device with implanted blood pump and oxygenator
AU2013243302B2 (en) * 2012-04-06 2017-04-27 Heartware, Inc. Ambulatory lung assist device with implanted blood pump and oxygenator
US9789240B2 (en) 2012-04-06 2017-10-17 Heartware, Inc. Ambulatory lung assist device with implanted blood pump and oxygenator
WO2013152309A1 (fr) 2012-04-06 2013-10-10 Heartware, Inc. Dispositif d'assistance pulmonaire ambulatoire équipé d'une pompe à sang implantée et d'un oxygénateur
US10245367B2 (en) 2012-04-06 2019-04-02 Heartware, Inc. Ambulatory lung assist device with implanted blood pump and oxygenator
EP2832383B1 (fr) * 2013-07-29 2023-08-30 Xenios AG Agencement doté d'une pompe à sang et commande de pompe
US10744255B2 (en) 2014-07-22 2020-08-18 Heartware, Inc. Cardiac support system and methods
US11185677B2 (en) 2017-06-07 2021-11-30 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
US11717670B2 (en) 2017-06-07 2023-08-08 Shifamed Holdings, LLP Intravascular fluid movement devices, systems, and methods of use
US11511103B2 (en) 2017-11-13 2022-11-29 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
US11229784B2 (en) 2018-02-01 2022-01-25 Shifamed Holdings, Llc Intravascular blood pumps and methods of use and manufacture
US10722631B2 (en) 2018-02-01 2020-07-28 Shifamed Holdings, Llc Intravascular blood pumps and methods of use and manufacture
US11964145B2 (en) 2019-07-12 2024-04-23 Shifamed Holdings, Llc Intravascular blood pumps and methods of manufacture and use
US11654275B2 (en) 2019-07-22 2023-05-23 Shifamed Holdings, Llc Intravascular blood pumps with struts and methods of use and manufacture
US11724089B2 (en) 2019-09-25 2023-08-15 Shifamed Holdings, Llc Intravascular blood pump systems and methods of use and control thereof
CN115068807A (zh) * 2022-05-31 2022-09-20 绍兴梅奥心磁医疗科技有限公司 脉冲式体外肺膜动力泵及体外膜肺氧合装置
CN115068807B (zh) * 2022-05-31 2024-05-28 绍兴梅奥心磁医疗科技有限公司 脉冲式体外肺膜动力泵及体外膜肺氧合装置

Also Published As

Publication number Publication date
SE8702673L (sv) 1987-06-29
SE8702673D0 (sv) 1987-06-29
IL80537A0 (en) 1987-02-27
GB2196854B (en) 1990-02-14
JPS63501929A (ja) 1988-08-04
GB2196854A (en) 1988-05-11
WO1987002894A3 (fr) 1987-10-08
EP0246302A1 (fr) 1987-11-25
DE3690585T1 (fr) 1988-01-28
GB8712167D0 (en) 1987-06-24

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