Implantable heart-assist device
First Claim
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.
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Accused Products
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.
227 Citations
32 Claims
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
- exterior surfaces, proximal and distal ends, and a longitudinal passageway defined by the interior surface and extending through the rigid housing;
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17. An extra-aortic balloon pump, comprising:
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(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. - View Dependent Claims (18, 19)
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20. An extra-aortic balloon pump, comprising:
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(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. - View Dependent Claims (21, 22, 23, 24)
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25. An extra-aortic balloon pump for use in cooperation with separate fluid pump means, said extra-aortic balloon pump comprising:
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(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. - View Dependent Claims (26, 27)
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28. An implantable heart-assist device, comprising:
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(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.
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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:
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(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. - View Dependent Claims (30, 31, 32)
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Specification