System and method for improving ventricular function

• US 20050246013A1
• Filed: 05/03/2004
• Published: 11/03/2005
• Est. Priority Date: 05/03/2004
• Status: Active Grant

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Granted Patent: US 7,374,573 B2
• Time in Patent Office: Days
• US Class Current: 623/2.100
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

An approach is disclosed for improving ventricular function of a patient'"'"'s heart. According to one embodiment, the system includes a pouch that defines a chamber dimensioned and configured to simulate at least a portion of a heart chamber. The pouch has a sidewall portion extending from an inflow annulus and terminating in a closed distal end spaced apart from the inflow annulus. A generally cylindrical outflow portion extends from the sidewall portion of the pouch and terminating in an outflow annulus thereof to provide for flow of fluid from the chamber through the outflow annulus. A valve is operatively associated with the inflow annulus of the pouch to provide for substantially unidirectional flow of fluid through the inflow annulus and into the chamber.

Claims

1. A system for improving operation of a heart, comprising:

a pouch that defines a chamber dimensioned and configured to simulate at least a portion of a heart chamber, the pouch having a sidewall portion extending from an inflow annulus and terminating in a closed distal end spaced apart from the inflow annulus;

a generally cylindrical outflow portion extending from the sidewall portion of the pouch and terminating in an outflow annulus thereof to provide for flow of fluid from the chamber through the outflow annulus; and

a valve operatively associated with the inflow annulus of the pouch to provide for substantially unidirectional flow of fluid through the inflow annulus and into the chamber.

2. The system of claim 1, wherein the sidewall portion of the pouch is generally pear-shaped, the inflow annulus having a reduced cross-sectional dimension relative to a cross-sectional dimension of the sidewall portion at a location spaced apart from the inflow annulus proximal the distal end.

3. The system of claim 1, wherein the valve further comprises at least one member moveable within a corresponding sidewall portion of the valve to provide for the substantially unidirectional flow of fluid into the chamber.

4. The system of claim 3, wherein the sidewall portion of the valve is attached at the inflow annulus of the pouch, at least a substantial portion of the valve being located within the chamber defined by the pouch and the at least one member is positioned for movement at least partially within the chamber proximal the inflow annulus.

5. The system of claim 3, wherein the valve further comprises one of a biological heart valve prosthesis, a mechanical heart valve prosthesis and a bio-mechanical heart valve prosthesis.

6. The system of claim 5, wherein the valve further comprises a biological heart valve prosthesis having at least two leaflets that are moveable relative to each other to provide for the substantially unidirectional flow of fluid into the chamber.

7. The system of claim 1, wherein the pouch further comprises at least one sheet of an animal tissue material.

8. The system of claim 7, wherein the at least one sheet of animal tissue material has opposed side surfaces, a rougher one of the opposed side surfaces of the at least one sheet of animal tissue material forming an interior wall of the chamber.

9. The system of claim 8, wherein the at least one sheet of animal tissue material comprises animal pericardium.

10. The system of claim 1, wherein the valve at the inflow annulus defines an inflow valve, the system further comprising an outflow valve positioned to provide for substantially unidirectional flow of fluid from the chamber and through the outflow portion.

11. The system of claim 10, wherein the outflow valve further comprises one of a biological heart valve prosthesis, a mechanical heart valve prosthesis and a bio-mechanical heart valve prosthesis.

12. The system of claim 10, wherein the outflow valve further comprises an inflow annulus and an outflow annulus, the inflow annulus of the outflow valve being attached proximal the outflow annulus of the outflow portion.

13. The system of claim 1, further comprising at least one connecting element attached to the sidewall portion of the pouch for tethering the sidewall portion relative to cardiac muscle.

14. A system for improving ventricular function, comprising:

a pouch dimensioned and configured for implantation within a ventricle of a patient'"'"'s heart, the pouch being fluidly connectable between a first valve at a mitral position of the patient'"'"'s heart and a second valve in an aortic position of the patient'"'"'s heart, the pouch configured to limit a volume of blood within the ventricle.

15. The system of claim 14, wherein at least one of the first valve and the second valve comprises a heart valve prosthesis attached to a corresponding annulus of the pouch.

16. The system of claim 14, wherein each of the first valve and the second valve comprises a corresponding heart valve prosthesis, the first valve being attached to the pouch to provide for substantially unidirectional flow of blood from an atrium into the pouch and the second valve being attached to provide for substantially unidirectional flow of blood from the pouch into an aorta of the patient.

17. The system of claim 14, wherein the pouch further comprises a generally pear-shaped sidewall portion having a cross-sectional diameter near the first valve that is less than a cross-sectional diameter thereof at a location spaced apart from the first valve, the first valve being connected at an inflow annulus of the pouch.

18. The system of claim 17, further comprising a generally tubular branch extending from the pear-shaped sidewall portion and terminating in an outflow end thereof, the second valve being attached relative to the tubular branch to provide for substantially free flow of blood from within the pouch and through the generally tubular branch and the second valve.

19. The system of claim 18, wherein the second valve comprises a heart valve prosthesis posited proximal an outflow end of the generally tubular branch.

20. The system of claim 14, wherein the pouch comprises at least one sheet of a biological tissue material, the at least one sheet having opposed side surfaces, a rougher one of the opposed side surfaces of the at least one sheet of animal tissue material forming an interior sidewall of the pouch.

21. The system of claim 14, further comprising at least one connecting element attached to the sidewall portion of the pouch for tethering the sidewall portion relative to cardiac muscle of the patient'"'"'s heart so as to maintain a desired configuration of the pouch.

22. A system for improving ventricular function of a patient'"'"'s heart, comprising:

means for limiting a volume of blood received within an enlarged ventricle of the patient'"'"'s heart;

means for providing for substantially unidirectional flow of blood into the means for limiting; and

means for providing for substantially unidirectional flow of blood out of the means for limiting into an aorta of the patient'"'"'s heart.

23. The system of claim 22, further comprising means for tethering a portion of the means for limiting relative to cardiac muscle of the patient'"'"'s heart so as to maintain a desired configuration of the means for limiting.

24. The system of claim 22, wherein the means for limiting further comprises a pouch formed of a natural tissue material configured to receive a volume of blood, the pouch having interior and exterior surfaces, the exterior surface being smoother than the interior surface of the pouch.

25. A method for improving ventricular function of a heart, comprising:

implanting a pouch in a ventricle, the pouch including an inflow annulus;

mounting an inflow valve associated with the inflow annulus of the pouch at a mitral position to provide for substantially unidirectional flow of blood through the inflow valve and into the implanted pouch; and

securing an outflow end portion of a generally cylindrical member at an aortic annulus, the generally cylindrical member extending from a sidewall of the pouch and terminating in the outflow end portion to provide fluid communication from within the pouch into an aorta.

26. The method of claim 25, further comprising mounting an outflow valve to provide from substantially unidirectional flow of blood from the pouch into the aorta.

27. The method of claim 25, further comprising tethering an exterior of the sidewall of the pouch relative to surrounding cardiac muscle to help maintain a desired configuration of the pouch.

28. The method of claim 25, further comprising removing fluid from a space in the ventricle between the pouch and surrounding cardiac tissue to facilitate self-remodeling of the heart.