Implantable heart-assist device

• US 5,222,980 A
• Filed: 09/27/1991
• Issued: 06/29/1993
• Est. Priority Date: 09/27/1991
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gealow, Kendra K.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): WILLSE, DAVID H
• Application Number:
  US07/766,942
• Time in Patent Office: 641 Days
• Field of Search: 417/474, 417/475, 600/18, 600/16, 600/17, 623/3, 623/26, 623/37
• US Class Current: 623/3.12
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/152 branching on and drawing blood from a blood vessel
• CPC Class Codes: A61M 60/274 the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
• CPC Class Codes: A61M 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/569 synchronous with the native heart beat
• CPC Class Codes: A61M 60/837 Aspects of flexible displacement members, e.g. shapes or materials
• CPC Class Codes: A61M 60/878 Electrical connections within the patient's body
• CPC Class Codes: A61M 60/882 Devices powered by the patient, e.g. skeletal muscle powered devices

Abstract

An implantable heart-assist device including extra-aortic balloon pump (EAB pump) for use in cooperation with a fluid pump is disclosed. The extra-aortic balloon pump includes a rigid, generally cylindrical housing and a flexible, generally cylindrical diaphragm residing generally within a longitudinal passageway in the rigid housing and secured to the rigid housing so as to create a plurality of separate expansion chambers. A plurality of fluid communication ports are provided for passing fluid into and out of the respective expansion chambers. The rigid housing includes interior and exterior surfaces, proximal and distal ends, and a longitudinal passageway. The diaphragm has an inner surface which defines a longitudinal lumen within the longitudinal passageway. The longitudinal lumen has a longitudinal axis and the respective expansion chambers and corresponding fluid communication ports are oriented axisymmetrically in respect to the longitudinal axis. In preferred embodiments, the fluid pump is a fluid filled bladder within an innervated skeletal muscle pouch. The skeletal muscle pouch is preferably created surgically from a latissimus dorsi muscle flap which is preferably generated during a prior surgical procedure. The fluid filled bladder communicates with the EAB pump via fluid communication conduits and the fluid communication ports. Contraction of the skeletal muscle pouch is stimulated by an implantable pulse train generator which is synchronized with the beating of the active heart. Methods of assisting an active heart using the disclosed implantable heart assist device are also disclosed.

Claims

1. An extra-aortic balloon pump for use in cooperation with separate fluid pump means, said extra-aortic balloon pump comprising:

exterior surfaces, proximal and distal ends, and a longitudinal passageway defined by the interior surface and extending through the rigid housing;

(b) a flexible, generally cylindrical diaphragm having inner and outer surfaces and residing generally within the longitudinal passageway, wherein the inner surface defines a longitudinal lumen within the longitudinal passageway, the lumen extending through said extra-aortic balloon pump; and

(c) means for securing the diaphragm to the rigid housing, wherein said securing means secure the diaphragm to the rigid housing so as to create a plurality of separate (comma) substantially parallel expansion chambers, wherein each of said plurality of expansion chambers are individually defined by one of a plurality of individual portions of the interior surface of the rigid housing in cooperation with one of a plurality of individual segments of the outer surface of the diaphragm and said securing means, wherein the diaphragm includes a plurality of balloon portions individually enclosing corresponding expansion chambers against the interior surface, wherein said extra-aortic balloon pump further comprises fluid communication means for separately exchanging fluids between each of the plurality of expansion chambers and said fluid pump means, wherein said fluid pump means are in communication with each of the respective expansion chambers via said fluid communication means, and wherein the respective expansion chambers can be expanded when fluid is directed into the respective expansion chambers.

2. The extra-aortic balloon pump of claim 1, wherein the lumen has a longitudinal axis and the respective plurality of expansion chambers are generally axisymmetric in respect to the longitudinal axis within a transverse cross-section of said extra-aortic balloon pump.

3. The extra-aortic balloon pump of claim 2, wherein the respective plurality of expansion chambers are generally axisymmetric in respect to the longitudinal axis within any transverse cross-section of said extra-aortic balloon pump.

4. The extra-aortic balloon pump of claim 3, wherein said fluid communication means include a plurality of fluid communication ports, wherein each of said plurality of expansion chambers is in fluid communication with one of said plurality of fluid ports.

5. The extra-aortic balloon pump of claim 4, wherein each of said plurality of fluid ports communicate with one of said plurality of expansion chambers through said rigid housing.

6. The extra-aortic balloon pump of claim 5, wherein each of said plurality of fluid ports communicates with one of said plurality of expansion chambers at one of a plurality of positions along the exterior surface of the rigid housing, which are equidistant from each of the respective proximal and distal ends of the rigid housing and axisymmetrically oriented about the housing in respect to the longitudinal axis of the longitudinal lumen.

7. The extra-aortic balloon pump of claim 6, wherein each of said plurality of positions along the exterior surface of the rigid housing is closer to one of said respective proximal and distal ends of said rigid housing, wherein the respective expansion chambers expand proximate said one of said respective proximal and distal ends prior to expanding proximate the other of said respective proximal and distal ends when fluid passes simultaneously into each of said plurality of expansions chambers via the respective fluid ports, and wherein said plurality of balloon portions expand simultaneously, first, proximate said one of said respective proximal and distal ends, and, second, proximate the other of said respective proximal and distal ends so as to create generally axisymmetric peristaltic waves along the inner surface of the flexible diaphragm proximate each respective balloon portion in respect to the longitudinal axis.

8. The extra-aortic balloon pump of claim 7, wherein each of the respective plurality of balloon portions have a first, generally contracted position and a second, generally expanded position, wherein the inner surface of the flexible diaphragm proximate each respective balloon portion is sufficiently removed from the inner surface proximate each other respective balloon portion so that fluid can pass against the entire inner surface of the flexible diaphragm when passing through the longitudinal lumen when the respective plurality of balloon portions are in the second, generally expanded position.

9. The extra-aortic balloon pump of claim 8, wherein each of said plurality of expansion chambers theoretically have an infinite number of intermediate positions between said first, generally contracted position and said second, generally expanded position, and wherein the respective expansion chambers are generally axisymmetric in respect to the longitudinal axis within any transverse cross-section of said extra-aortic balloon pump when in any of said first or second positions or any of said theoretically infinite number of intermediate positions.

10. The extra-aortic balloon pump of claim 9, wherein the plurality of expansions chambers are three in number, and the plurality of fluid ports are three in number, each of which is axisymmetrically oriented in respect to the longitudinal axis.

11. The extra-aortic balloon pump of claim 10, wherein the flexible, generally cylindrical diaphragm is made of a resilient, biocompatible synthetic material which can expand and contract.

12. The extra-aortic balloon pump of claim 11, wherein the biocompatible synthetic material is polyurethane.

13. The extra-aortic balloon pump of claim 11, wherein the rigid housing and the longitudinal lumen are generally straight.

14. The extra-aortic balloon pump of claim 13, further including a plurality of curved end extension members, the curved end extension members including a first end extension member interconnected with the proximal end of the rigid housing, and a second end extension member interconnected with the distal end of the rigid housing, wherein the respective curved end extension members each define a curved lumen in communication with the longitudinal lumen, wherein the longitudinal lumen is generally straight and the respective curved end lumens are curved.

15. The extra-aortic balloon pump of claim 11, wherein said securing means include a bonding agent capable of securing portions of the outer surface of the flexible diaphragm to portions of the interior surface of the rigid housing.

16. The extra-aortic balloon pump of claim 15, wherein said bonding agent is a silicone adhesive.

17. An extra-aortic balloon pump, comprising:

(a) a rigid housing having interior and exterior surfaces, proximal and distal ends, and a longitudinal passageway extending therebetween; and

(b) a generally cylindrical, flexible diaphragm, wherein the generally cylindrical diaphragm is secured to said rigid housing so as to provide an inner lining for said longitudinal passageway, said inner lining defining a longitudinal lumen passing through the rigid housing within the longitudinal passageway, wherein the generally cylindrical diaphragm is secured to the interior surface of the rigid housing so as to separate a plurality of expansion chambers defined by separate portions of the generally cylindrical diaphragm in cooperation with separate segments of the interior surface of the rigid housing, the rigid housing including a plurality of fluid communication ports, wherein said plurality of fluid communication ports and said plurality of expansions chambers are equal in number and wherein each of said plurality of fluid communication ports is in fluid communication with one of said plurality of expansion chambers such that fluid can pass into and out of each of the respective expansion chambers via a corresponding compression port, wherein the longitudinal lumen is generally straight and has a longitudinal axis, wherein said plurality of fluid communication ports and said plurality of expansion chambers are separately axisymmetric in respect to the longitudinal axis.

18. The extra-aortic balloon pump of claim 17, wherein the fluid communication ports are each an equal distance from each of the respective proximal and distal ends and displaced closer to one of said respective ends than the other, wherein the respective expansion chambers expand proximate the end of the rigid housing closest to the plurality of fluid communication ports when the expansion chambers expand in response to the passage of an expansion fluid into the respective expansion chambers via the respective fluid communication ports.

19. The extra-aortic balloon pump of claim 18, wherein the inner lining of the longitudinal passageway proximate each respective expansion chamber can move generally inwardly toward the longitudinal axis of the longitudinal lumen in response to the passage of the expansion fluid into the respective expansion chambers via the respective fluid communication ports, and wherein segments of the inner lining proximate each respective expansion chamber and more proximate the corresponding fluid communication port can move inwardly toward the longitudinal axis prior to other segments of the inner lining more removed from the corresponding fluid communication ports such that the respective segments of the inner lining will move toward the longitudinal axis in a manner which creates a peristaltic wave which extends longitudinally along the inner lining in a direction away from the segment of the inner lining most proximate the respective fluid communication port toward other segments thereof further removed therefrom.

20. An extra-aortic balloon pump, comprising:

(a) a rigid housing having interior and exterior surfaces, proximal and distal ends, and a longitudinal passageway defined by the interior surface and extending longitudinally through the rigid housing; and

(b) flexible fluid separation means interconnected with said rigid housing, said flexible fluid separation means including an inner surface which defines a longitudinal lumen passing through the longitudinal passageway and having a longitudinal axis, wherein said flexible fluid separation means cooperates with the rigid housing to define a plurality of expansion chambers separated from the longitudinal lumen by said flexible fluid separation means, said rigid housing further including a fluid communication port communicating with each of said plurality of expansion chambers, wherein fluid can pass into or out of each of said plurality of expansion chambers via the respective corresponding fluid communication ports to expand or contract the respective expansion chamber and thereby respectively decrease or increase a fluid volume of the longitudinal lumen, wherein the plurality of expansion chambers and the plurality of corresponding fluid communication ports are oriented axisymmetrically in respect to the longitudinal axis.

21. The extra-aortic balloon pump of claim 20, wherein said flexible fluid separation means includes an expandable diaphragm, and wherein the expandable diaphragm expands in response to an expansion of any of said expansion chambers.

22. The extra-aortic balloon pump of claim 21, further comprising fluid delivery means for delivering and removing an expansion fluid to each of the respective expansion chambers via the corresponding fluid communication ports, wherein each of said plurality of expansion chambers have an expandable chamber volume, wherein the expansion or contraction of the respective expansion chamber can be coordinated so that the chamber volume of each respective expansion chamber can be expanded or contracted simultaneously with the expansion or contraction of the respective remaining expansion chambers.

23. The extra-aortic balloon pump of claim 22, wherein the transverse cross-sections of the plurality of expansion chambers are axisymmetric in respect to the longitudinal axis when fully expanded in normal use.

24. The extra-aortic balloon pump of claim 23, wherein each of the plurality of fluid communication ports are located an equal distance from each of the respective ends of the rigid housing, wherein each of the plurality of fluid communication ports are closer to one of the respective ends, and wherein the respective fluid communication ports are axisymmetrically oriented in respect to the longitudinal axis.

25. An extra-aortic balloon pump for use in cooperation with separate fluid pump means, said extra-aortic balloon pump comprising:

(a) a rigid housing including interior and exterior surfaces, proximal and distal ends, and a longitudinal passageway defined by the interior surface and extending through the rigid housing;

(b) a flexible, generally cylindrical diaphragm having inner and outer surfaces and residing generally within the longitudinal passageway, wherein the inner surface defines a longitudinal lumen within the longitudinal passageway, the lumen extending through said extra-aortic balloon pump; and

(c) means for securing the diaphragm to the rigid housing, wherein said securing means secure the diaphragm to the rigid housing so as to create a plurality of separate expansion chambers, wherein each of said plurality of expansion chambers are individually defined by one of a plurality of individual portions of the interior surface of the rigid housing in cooperation with one of a plurality of individual segments of the outer surface of the diaphragm and said securing means;

wherein the diaphragm includes a plurality of balloon portions individually enclosing corresponding expansion chambers against the interior surface;

wherein said extra-aortic balloon pump further comprises fluid communication means for separately exchanging fluids between each of the plurality of expansion chambers and said fluid pump means;

wherein said fluid pump means are in communication with each of the respective expansion chambers via said fluid communication means, and wherein the respective expansion chambers can be expanded simultaneously when fluid is simultaneously directed into the respective expansion chambers;

wherein the lumen has a longitudinal axis and the respective plurality of expansion chambers are generally axisymmetric in respect to the longitudinal axis within any transverse cross-section of said extra-aortic balloon pump;

wherein said fluid communication means include a plurality of fluid communication ports;

wherein each of said plurality of expansion chambers is in fluid communication with one of said plurality of fluid ports;

wherein each of said plurality of fluid ports communicate with one of said plurality of expansion chambers through said rigid housing;

wherein each of said plurality of fluid ports communicates with one of said plurality of expansion chambers at one of a plurality of positions along the exterior surface of the rigid housing, which are equidistant from each of the respective proximal and distal ends of the rigid housing and axisymmetrically oriented about the housing in respect to the longitudinal axis of the longitudinal lumen;

wherein each of said plurality of positions along the exterior surface of the rigid housing is closer to one of said respective proximal and distal ends of said rigid housing, wherein the respective expansion chambers expand proximate said one of said respective proximal and distal ends prior to expanding proximate the other of said respective proximal and distal ends when fluid passes simultaneously into each of said plurality of expansions chambers via the respective fluid ports, and wherein said plurality of balloon portions expand simultaneously, first, proximate said one of said respective proximal and distal ends, and, second, proximate the other of said respective proximal and distal ends so as to create generally axisymmetric peristaltic waves along the inner surface of the flexible diaphragm proximate each respective balloon portion in respect to the longitudinal axis;

wherein each of the respective plurality of balloon portions have a first, generally contracted position and a second, generally expanded position, wherein the inner surface of the flexible diaphragm proximate each respective balloon portion is sufficiently removed from the inner surface proximate each other respective balloon portion so that fluid can pass against the entire inner surface of the flexible diaphragm when passing through the longitudinal lumen when the respective plurality of balloon portions are in the second, generally expanded position.

26. The extra-aortic balloon pump of claim 25, wherein each of said plurality of expansion chambers theoretically have an infinite number of intermediate positions between said first, generally contracted position and said second, generally expanded position, and wherein the respective expansion chambers are generally axisymmetric in respect to the longitudinal axis within any transverse cross-section of said extra-aortic balloon pump when in any of said first or second positions or any of said theoretically infinite number of intermediate positions.

27. The extra-aortic balloon pump of claim 26, wherein the plurality of expansions chambers are three in number, and the plurality of fluid ports are three in number, each of which is axisymmetrically oriented in respect to the longitudinal axis.

28. An implantable heart-assist device, comprising:

(a) an extra-aortic balloon pump, including;

(i) a rigid housing having interior and exterior surfaces, proximal and distal ends, and a longitudinal passageway defined by the interior surface and extending longitudinally through the rigid housing; and

(ii) flexible fluid separation means interconnected with said rigid housing, said flexible fluid separation means including an inner surface which defines a longitudinal lumen passing through the longitudinal passageway and having a longitudinal axis, wherein said flexible fluid separation means cooperates with the rigid housing to define a plurality of expansion chambers separated from the longitudinal lumen by said flexible fluid separation means, said rigid housing further including a fluid communication port communicating with each of said plurality of expansion chambers, wherein fluid can pass into or out of each of said plurality of expansion chambers via the respective corresponding fluid communication ports to expand or contract the respective expansion chamber and thereby respectively decrease or increase a fluid volume of the longitudinal lumen, wherein the plurality of expansion chambers and the plurality of corresponding fluid communication ports are oriented axisymmetrically in respect to the longitudinal axis; and

(b) a fluid pump, including;

(i) a collapsible, fluid-filled, shape-retaining bladder;

(ii) innervated skeletal muscle pouch, the innervated skeletal muscle pouch having a central, partially enclosed region in which the fluid-filled, collapsible bladder is inserted;

(iii) fluid conduit communication means for interconnecting the collapsible, fluid-filled bladder with the fluid communication ports of the rigid housing, wherein fluid from the collapsible bladder can communicate with each of the plurality of expansion chambers of the extra-aortic balloon pump via said fluid conduit communication means; and

(iv) an implantable pulse train generator including a nerve cuff electrode, wherein the nerve cuff electrode is attached to the innervated skeletal muscle pouch such that an electrical pulse train can be transmitted to the innervated skeletal muscle pouch to stimulate repetitive contractions of the innervated skeletal muscle pulse which in turn cause a repetitive compression of the fluid-filled, shape-retaining, collapsible bladder so as to cause a repetitive expansion of each of the plurality of expansion chambers in the extra-aortic balloon pump in response to the repetitive contraction of the innervated skeletal muscle pulse.

29. A method of providing counter pulsation heart assistance to an individual, the individual having an active heart, a vascular system interconnected with the heart including a descending aorta which receives blood from the heart, and a latissimus dorsi muscle, said method comprising the steps of:

(1) providing an implantable heart-assist device including;

(a) an extra-aortic balloon pump, including;

(i) a rigid housing having interior and exterior surfaces, proximal and distal ends, and a longitudinal passageway defined by the interior surface and extending longitudinally through the rigid housing; and

(ii) flexible fluid separation means interconnected with said rigid housing, said flexible fluid separation means including an inner surface which defines a longitudinal lumen passing through the longitudinal passageway and having a longitudinal axis, wherein said flexible fluid separation means cooperates with the rigid housing to define a plurality of expansion chambers separated from the longitudinal lumen by said flexible fluid separation means, said rigid housing further including a fluid communication port communicating with each of said plurality of expansion chambers, wherein fluid can pass into or out of each of said plurality of expansion chambers via the respective corresponding fluid communication ports to expand or contract the respective expansion chamber and thereby respectively decrease or increase a fluid volume of the longitudinal lumen, wherein the plurality of expansion chambers and the plurality of corresponding fluid communication ports are oriented axisymmetrically in respect to the longitudinal axis; and

(b) a fluid pump, including;

(i) a collapsible, fluid-filled, shape-retaining bladder;

(ii) a skeletal muscle pouch, the skeletal muscle pouch having a central, partially enclosed region in which the fluid-filled, collapsible bladder is inserted;

(iii) fluid conduit communication means for interconnecting the collapsible, fluid-filled bladder with the fluid communication ports of the rigid housing, wherein fluid from the collapsible bladder can communicate with each of the plurality of expansion chambers of the extra-aortic balloon pump via said fluid conduit communication means;

(iv) an implantable pulse train generator including an electrode and heart synchronization means for electrically interconnecting the implantable pulse train generator with the active heart and for synchronizing a repetitive generation of electrical pulses to stimulate the contraction of the muscle pouch with repetitive electrical impulses from the heart, wherein the electrode can be attached to the skeletal muscle pouch such that an electrical pulse train can be transmitted to the skeletal muscle pouch to stimulate repetitive contractions of the innervated skeletal muscle pulse which in turn cause a repetitive compression of the fluid-filled, shape-retaining, collapsible bladder so as to cause a repetitive expansion of each of the plurality of expansion chambers in the extra-aortic balloon pump in response to the repetitive contraction of the skeletal muscle pulse, wherein the step of providing a heart-assist device includes surgically creating the skeletal muscle pulse a surgical procedure using the individuals latissimus dorsi muscle to create a muscle flap which is subsequently joined together to form the skeletal muscle pouch within the individual; and

(2) surgically implanting the heart-assist device in the individual, wherein the implantable pulse train generator is interconnected to receive and be synchronized with electrical impulses of the individual'"'"'s active heart and the electrode is interconnected with the skeletal muscle pouch, wherein the step of implanting includes grafting the extra-aortic balloon pump into the vascular system proximate the descending aorta.

30. The method of claim 29 wherein the step of implanting the heart-assist device includes synchronizing the implantable pulse train generator with the electrical impulses of the active heart such that the repetitive contraction of the innervated skeletal muscle pouch is repetitively initiated at or immediately prior to the beginning of cardiac diastole.

31. A method of implanting a heart-assist device of claim 29 wherein the step of implanting the heart-assist device includes the extra-aorta balloon pump being grafted into the vascular system in series with the descending aorta.

32. A method of implanting a heart-assist device of claim 29 wherein the step of implanting the heart-assist devices includes the extra-aorta balloon pump being grafted into the vascular system in parallel with the descending aorta.