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EP0280301A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Biocompatible ventricular assist and arrhythmia control device

Assignee: Vascor Inc
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Filing: 1988-02-25
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Granted: —
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Expires: 2008-02-25
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Abstract

Abstract A device (10) for compressing a ventricle (12) of a heart (102) from one or more sides in synchronism with the natural contraction of the ventricle (systole), and providing arrhythmia control of the heart, is completely implantable in the body (100) of a patient user externally of the heart. Compression of the ventricle (12) is produced by a plurality of spaced compression plate assemblies (118) and a ventricle apex-­compression plate (not shown), a single compression plate-band assembly (300, 304) or tightenable bands (300ʹ). The compression plate assemblies (118) comprise suitable located electrodes (144, 152, 154) for heart monitoring purposes. A power supply (32) of the implanted device (10) can be recharged transcutaneously, and various other components (36, 38, 40, 52, 54, 56, 58, 60, 62, 68) of the device can be noninvasively programmed and interrogated by external circuits (48, 50). The compression plate assemblies (118) may be operated by a small brushless DC motor (24). An implantable manual pump mechanism (44) for operating the compression plate assemblies (118), also is provided for emergency purposes. The components of the implanted device also include a cardiac pacer (36), a defibrillator/cardioverter (38), a recorder (40) and an alarm (42).

Inventors

  • 👤 Marlin S. Heilman
  • 👤 Steve A. Kolenik

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-24 11:13
CPC Classifications
A; A61; A61N; A61N1/00; A61N1/18; A61N1/32; A61N1/36; A61N1/362; A61N1/365; A61M; A61M60/00; A61M60/10; A61M60/122; A61M60/165; A61M60/178; A61M60/20; A61M60/247; A61M60/253; A61M60/258; A61M60/40; A61M60/403; A61M60/408; A61M60/411; A61M60/50; A61M60/508; A61M60/515; A61M60/538; A61N1/38; A61N1/39; A61N1/3956; A61M2205/00; A61M2205/33; A61M2205/3303; A61N1/3627

Claims Analysis

Total Claims: 48
Claim 1
Independent Claim 85 words
A ventricular assist device which can be implanted in a patient user exterior to the heart and which comprises: a pumping means which includes one or more movable ventricle compression assemblies for engaging an outer surface of at least one heart ventricle; operating means for cyclically actuating the one or more compression assemblies, such that the ventricle is, first, compressed to aid blood ejection therefrom, and second, released to permit refilling; control means for regulating actuation of the operating means; and an electrical power source.
Claim 2
Dependent Claim 85 words
A ventricular assist device which can be implanted in a patient user exterior to the heart and which comprises: a pumping means which includes one or more movable ventricle compression assemblies for engaging an outer surface of at least one heart ventricle; operating means for cyclically actuating the one or more compression assemblies, such that the ventricle is, first, compressed to aid blood ejection therefrom, and second, released to permit refilling; control means for regulating actuation of the operating means; and an electrical power source.
Claim 3
Dependent Claim 31 words
The ventricular assist device as recited in claim 1, in which: the operating means includes an electrical motor assembly; and the control means enables cyclical operation of the electrical motor assembly.
Claim 4
Dependent Claim 24 words
The ventricular assist device as recited in claim 2, in which the electrical motor assembly includes an electrical motor and a rotary-to-axial drive-converting mechanism.
Claim 5
Dependent Claim 31 words
The ventricular assist device as recited in claim 3, in which the rotary-to-axial drive-converting mechanism includes a rotatable member and a reciprocating member driven axially by rotation of the rotatable member.
Claim 6
Dependent Claim 35 words
The ventricular assist device as recited in claim 3 or 4, in which the one or more movable ventricle compression assemblies are actuated by axial movement of the reciprocating member of the rotary-to-axial drive-converting mechanism.
Claim 7
Dependent Claim 51 words
The ventricular assist device as recited in anyone of the claims 1 to 5, in which the one or more movable ventricle compression assemblies each includes a pressure plate mounted on a compressive arm via an axle/bearing mount such that the pressure plate can follow the natural movement of the heart.
Claim 8
Dependent Claim 30 words
The ventricular assist device as recited in claim 2, in which the electrical motor assembly is contained within a motor assembly housing that is replaceable separate from the pumping means.
Claim 9
Dependent Claim 64 words
The ventricular assist device as recited in anyone of claims 2 to 7, in which the electric motor assembly actuates the one or more movable ventricle compression assemblies of the pumping means by way of fluid-filled coupling system; and the fluid-filled coupling systems includes separate reciprocating means, one in the electrical motor assembly and one in a pumping means housing, connected by elastomeric tubing.
Claim 10
Dependent Claim 25 words
The ventricular assist device as recited in anyone of the claims 1 to 8, in which each ventricle compression assembly includes a metal pressure plate.
Claim 11
Dependent Claim 38 words
The ventricular assist device as recited in anyone of the claims 1 to 9, in which the one or more ventricle compression assemblies each includes a contact pad for gluing and/or suturing the compression assembly to the ventricle.
Claim 12
Dependent Claim 22 words
The ventricular assist device as recited in claim 10, in which the contact pad is formed of reinforced soft, electrically insulating material.
Claim 13
Dependent Claim 67 words
The ventricular assist device as recited in anyone of claims 1 to 11, in which the electrical power source includes a pack of rechargeable batteries and a pickup coil, with the batteries being disposed in a casing capable of subcutaneous implantation such that the batteries can be recharged transcutaneously through the pickup coil; and implantable electrical cable means connects the electrical power source to the operating means.
Claim 14
Dependent Claim 101 words
The ventricular assist device as recited in anyone of the claims 1 to 12, in which: the control means includes control circuitry disposed in an electronic module which is capable of subcutaneous implantation such that circuitry contained therein can be programmed and/or interrogated transcutaneously; said electronic module is disposed in the same casing in which components of the power source are implanted; said control circuitry is connected to the pumping means and/or to the operating means by electrical conductor means insulated within implantable electrical cable means; and said power source is connected to the operating means by implantable electrical cable means.
Claim 15
Dependent Claim 52 words
The ventricular assist device as recited in anyone of the claims 1 to 13, which further includes electrode means mounted adjacent at least one of the one or more ventricle compression assemblies, for sensing cardiac electrical signals and transmitting said signals to the control means via respective ones of the conductor means.
Claim 16
Dependent Claim 29 words
The ventricular assist device as recited in anyone of the claims 1 to 14, in which the electrode means is formed of titanium wire mesh or platinum alloy mesh.
Claim 17
Dependent Claim 44 words
The ventricular assist device as recited in anyone of the claims 1 to 15, which further includes circuitry for producing heart pacer pulses and also includes electrical conductor means for applying said pacer pulses to electrode means mounted adjacent at least one heart ventricle.
Claim 18
Dependent Claim 43 words
The ventricular assist device as recited in anyone of the claims 1 to 16, which further includes circuitry for producing heart cardioverting/defibrillating pulses and also includes electrical conductor means for applying said pulses to electrode means mounted adjacent at least one heart ventricle.
Claim 19
Dependent Claim 48 words
The ventricular assist device as recited in claim 17, in which, prior to cardioverting/defibrillating pulse delivery, the control means causes the operating means to close each of the one or more movable ventricle compression assemblies, thereby removing blood from the heart and lowering the cardiac cardioversion/defibrillation energy threshold.
Claim 20
Dependent Claim 63 words
The ventricular assist device as recited in claim 14, in which: the cardiac electric signal transmitting electrical conductor means is contained within additional electrical cable means mounted adjacent respective ones of the one or more ventricle compression assemblies having said sensing electrode means; and said additional cable means is connected with the control means via a portion of said first-­mentioned electrical cable means.
Claim 21
Dependent Claim 39 words
The ventricular assist device as recited in anyone of the claims 1 to 19, which further includes servocontrol means for automatically adjusting ventricular assist device pumping assistance to the level required by the natural heart to maintain blood flow.
Claim 22
Dependent Claim 87 words
The ventricular assist device as recited in anyone of claims 1 to 20, which further includes: sensing means, including said cardiac electrical signal sensing electrode means, for sensing measurement of systolic blood pressure, stroke volume, blood flow rate, ejection fraction, compression assembly position and/or displacement, electrical current consumption by the operating means, cardiac rate, electrocardiogram morphology, and/or cardiac rate acceleration; and means in said control circuitry for utilizing input from said sensing means to adjust operating parameters of the operating means in accordance with preprogrammed cardiac parameters.
Claim 23
Dependent Claim 38 words
The ventricular assist device as recited in anyone of the claims 1 to 21, which further includes a movable ventricle compression means for engaging a ventricular apex, the apex-engaging compression means also being operable by the operating means.
Claim 24
Dependent Claim 50 words
The ventricular assist device as recited in claim 22, in which at least one of the ventricle compression assemblies engages a side of the at least one heart ventricle and the operating means permits sequential movement of the apex-engaging compression means and the side-engaging compression assembly in a ventricle-compressing operation.
Claim 25
Dependent Claim 32 words
The ventricular assist device as recited in anyone of the claims 1 to 23, in which the control means includes circuitry for conducting automatic self-tests, such as analysis of remaining battery capacity.
Claim 26
Dependent Claim 41 words
The ventricular assist device as recited in anyone of the claims 1 to 24, in which the control means includes circuitry for activating a patient alarm in response to malfunction conditions, such as low battery voltage in an implanted power source.
Claim 27
Dependent Claim 45 words
The ventricular assist device as recited in anyone of the claims 16 to 25, which also includes circuitry for initiating a real-­time electrophysiology/hemodynamic (EH) evaluation mode in which the pacer circuitry is placed into VVT mode (ventricular pacing, ventricular sensing, pulse triggered by sensed event).
Claim 28
Dependent Claim 35 words
The ventricular assist device as recited in anyone of the claims 1 to 26, which also includes manually operable means for moving at least one of the movable ventricle compression assemblies to compress the ventricle.
Claim 29
Dependent Claim 50 words
The ventricular assist device as recited in anyone of the claims 1 to 27, which further includes: sensing circuitry which forms part of the control means and which is capable of detecting a malfunction in the device and/or the heart; and an alarm which is responsive to said malfunction-­sensing circuitry.
Claim 30
Dependent Claim 41 words
The ventricular assist device as recited in anyone of the claims 1 to 28, which also includes a means for recording data produced during the operation of said ventricular assist device, the recording means being implantable and capable of transcutaneous interrogation.
Claim 31
Dependent Claim 79 words
The ventricular assist device as recited in anyone of the claims 1 to 29, in which the pumping means also includes: a rigid support member external to the heart; at least one resilient band having an intermediate portion surgically implantable in an interventricular wall of the heart, the band having opposite ends which connect to the rigid support member; and one or more of the movable ventricle compression assemblies positioned between the rigid support member and the resilient band.
Claim 32
Dependent Claim 69 words
The ventricular assist device as recited in anyone of the claims 1 to 30, in which the pumping means includes at least one resilient band having an intermediate portion surgically implanted in an interventricular wall of the heart and having end portions fixed to two movable ventricle compression assemblies such that actuation of the compression assemblies constricts the at least one resilient interventricular band and thereby compresses the ventricle.
Claim 33
Dependent Claim 55 words
A cardiac compression assembly which is intended for use in a cardiac assist device and which includes: a pressure plate; a contact pad mounted on a cardiac compression assembly for gluing and/or suturing the assembly to at least one cardiac chamber; and mounting means for mounting the cardiac compression assembly in a cardiac assist device.
Claim 34
Dependent Claim 55 words
A cardiac compression assembly which is intended for use in a cardiac assist device and which includes: a pressure plate; a contact pad mounted on a cardiac compression assembly for gluing and/or suturing the assembly to at least one cardiac chamber; and mounting means for mounting the cardiac compression assembly in a cardiac assist device.
Claim 35
Dependent Claim 42 words
The cardiac compression assembly as recited in claim 32, which further includes one or more electrodes mounted thereon for sensing cardiac signals, transmitting said signals along one or more insulated electrical conductors, and/or delivering heart pacemaker or cardioverter/defibrillator pulses to the heart.
Claim 36
Dependent Claim 32 words
The cardiac compression assembly as recited in claim 33, which further includes a cable that contains the one or more electrical conductors and that is itself mounted on said cardiac compression assembly.
Claim 37
Dependent Claim 26 words
The cardiac compression assembly as recited in any­one of the claims 32 to 34, in which the compression plate is formed of titanium or platinum alloy.
Claim 38
Dependent Claim 27 words
The cardiac compression assembly as recited in any­one of the claims 32 to 35, in which the contact pad is formed of reinforced soft, electrically insulating material.
Claim 39
Dependent Claim 32 words
The cardiac compression assembly as recited in anyone of the claims 32 to 36, in which the thickness of the contact pad is progressively reduced toward its periphery to avoid edge stress.
Claim 40
Dependent Claim 40 words
The cardiac compression assembly as recited in anyone of the claims 32 to 36, in which the contact pad is formed of silicone rubber reinforced with Dacron fibers and having a durometer in a range of the order of 30-50.
Claim 41
Dependent Claim 24 words
The ventricular assist device as recited in anyone of the claims 8 to 31, wherein the separate reciprocating means are first and second bellows.
Claim 42
Dependent Claim 22 words
The ventricular assist device as recited in anyone of the claims 8 to 31, wherein the separate reciprocating means are rolling diaphragms.
Claim 43
Dependent Claim 28 words
The ventricular assist device as recited in anyone of the claims 9 to 31, in which the metal pressure plate is formed of a nickel or titanium alloy.
Claim 44
Dependent Claim 32 words
The ventricular assist device as recited in anyone of the claims 11 to 31, in which the thickness of the contact pad is progressively reduced toward its periphery to avoid edge stress.
Claim 45
Dependent Claim 40 words
The ventricular assist device as recited in anyone of the claims 11 to 31, in which the contact pad is formed of silicone rubber reinforced with Dacron fibers and having a durometer in a range on the order of 30-50.
Claim 46
Dependent Claim 38 words
The ventricular assist device as recited in anyone of the claims 16 to 31, in which said pacer pulse electrode means and electrical conductor means also are said cardiac electric­al signal sensing electrode means and electrical conductor means.
Claim 47
Dependent Claim 39 words
The ventricular assist device as recited in anyone of the claims 17 to 31, in which said heart cardioverting/defibrillating pulse electrode means and electrical conductor means also are said cardiac electrical signal sensing electrode means and electrical conductor means.
Claim 48
Dependent Claim 34 words
The ventricular assist device as recited in anyone of the claims 28 to 31, in which said alarm is responsive to device malfunction conditions such as low battery voltage in an implanted power source.

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