Heart valve prosthesis and methods of manufacture and use

• US 20060265056A1
• Filed: 05/12/2006
• Published: 11/23/2006
• Est. Priority Date: 05/13/2005
• Status: Active Grant

• Current Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Original Assignee: Corevalve Incorporated (Medtronic Plc)
• Inventors: Nguyen, MyKim, Nguyen, Than, Michiels, Robrecht, Komatsu, Stanley, Nguyen, Hung
• Granted Patent: US 9,504,564 B2
• Time in Patent Office: Days
• US Class Current: 623/2.180
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

Claims

1. A valve prosthesis comprising:

a self-expanding multi-level frame having a contracted delivery configuration and an expanded deployed configuration, the multi-level frame having in the expanded deployed configuration an enlarged outflow section with a first nominal diameter, a conical inflow section having a second nominal diameter and a constriction region having a third fixed diameter smaller than the first and second nominal diameters; and

a valve body affixed to the multi-level frame, the valve body comprising a plurality of leaflets affixed to a skirt.

2. The valve prosthesis of claim 1 wherein the multi-level frame comprises a cell pattern defined by unequal length zig-zags.

3. The valve prosthesis of claim 1 wherein the conical section has a proximal end and the conical inflow section flares outward towards the proximal end.

4. The valve prosthesis of claim 1 wherein adjoining leaflets are affixed together to form commissures and have free edges that define coaptation edges and a center of coaptation, the commissures being longitudinally offset from the center of coaptation.

5. The valve prosthesis of claim 4 wherein the commissures are affixed to the multi-level frame at a location proximal of the center of coaptation.

6. The valve prosthesis of claim 5 wherein the multi-level frame comprises a cell pattern and the commissures include flaps that span an entire area of at least one cell of the cell pattern.

7. The valve prosthesis of claim 4 wherein the commissures and coaptation edges of the leaflets define catenaries that substantially uniformly distribute loads over the leaflets.

8. The valve prosthesis of claim 7 wherein the catenaries are configured to reduce horizontal loads applied to the commissures.

9. The valve prosthesis of claim 1 wherein the leaflets are affixed to the skirt at joints, and the joints are affixed to the frame to evenly distribute forces through the valve body to the multi-level frame.

10. The valve prothesis of claim 9 wherein the multi-level frame further comprises a cell pattern that defines a contour configured to support the joints.

11. The valve prosthesis of claim 4 wherein each leaflet is individually formed and comprises an enlarged lateral end having a plurality of flaps that are folded over to increase the durability of the commissures.

12. The valve prosthesis of claim 1 wherein the skirt further comprises a plurality of longitudinally-oriented reinforcing tabs or pleats.

13. The valve prosthesis of claim 12 wherein the reinforcing tabs or pleats are affixed to the multi-level frame.

14. The valve prosthesis of claim 12 wherein the skirt further comprises a plurality of end tabs adapted to be affixed to a proximal-most row of cells of the multi-level frame.

15. The valve prosthesis of claim 1 wherein the leaflets comprise a material selected from one of:

porcine, bovine, equine or other mammalian pericardial tissue, synthetic material or polymeric material.

16. The valve prosthesis of claim 1 wherein the valve body is deployed supra-annularly of a patient'"'"'s aortic annulus when the valve prosthesis is delivered within a patient'"'"'s aortic valve and the multi-level frame is in the expanded deployed configuration.

17. The valve prosthesis of claim 1 wherein the multi-level frame is configured to hold a patient'"'"'s native valve permanently open in the expanded deployed configuration.

18. The valve prosthesis of claim 1 wherein the multi-level frame is configured to permit access to a patient'"'"'s coronary arteries in the expanded deployed configuration.

19. The valve prosthesis of claim 1 wherein multi-level frame has proximal and distal ends and a plurality of cell patterns that vary in size between the proximal and distal ends.

20. The valve prosthesis of claim 1 wherein the constriction region comprises a plurality of cell patterns configured to provide a pre-determined radius of curvature for a transition from the constriction region to the outflow section.

21. The valve prosthesis of claim 1 wherein the skirt comprises a synthetic material.

22. The valve prosthesis of claim 21 wherein the skirt has a tubular shape in an undeformed configuration.

23. The valve prosthesis of claim 22 wherein skirt is configured in conical frustum shape formed by deforming the synthetic material.

24. The valve prosthesis of claim 23 wherein the conical frustum shape is formed by creating a plurality of longitudinally-oriented pleats in the synthetic material.

25. The valve prosthesis of claim 1 wherein the skirt comprises two or more individual panels of animal pericardial material.

26. The valve prosthesis of claim 1 wherein the skirt comprises two or more conjoined panels of animal pericardial material.

27. A valve prosthesis comprising:

a valve body comprising a plurality of leaflets affixed to a skirt, adjoining leaflets affixed together to form commissures and having free edges that define coaptation edges and a center of coaptation,

wherein the commissures are longitudinally offset from the center of coaptation and define catenaries that substantially uniformly distribute loads over the leaflets.

28. The valve prosthesis of claim 27 wherein the catenaries are configured to reduce horizontal loads applied to the commissures.

29. The valve prosthesis of claim 27 wherein each leaflet is individually formed and comprises an enlarged lateral end having a plurality of flaps that are folded over to increase the durability of the commissures.

30. The valve prosthesis of claim 27 wherein the skirt further comprises a plurality of longitudinally-oriented reinforcing tabs or pleats.

31. The valve prosthesis of claim 27 wherein the leaflets comprise a material selected from one of:

porcine, bovine, equine or other mammalian pericardial tissue, synthetic material or polymeric material.

32. The valve prosthesis of claim 27 wherein the valve prosthesis further comprises a self-expanding frame, the leaflets are affixed to the skirt at joints, and the joints are affixed to the frame to evenly distribute forces through the valve body to the frame.

33. The valve prothesis of claim 32 wherein the frame further comprises a cell pattern that defines a contour configured to support the joints.

34. The valve prosthesis of claim 30 wherein the valve prosthesis further comprises a self-expanding frame and the reinforcing tabs or pleats are affixed to the frame.

35. The valve prosthesis of claim 27 further comprising a self-expanding frame having a contracted delivery configuration and an expanded deployed configuration.

36. The valve prosthesis of claim 35 wherein the frame comprises a cell pattern defined by unequal length zig-zags.

37. The valve prosthesis of claim 35 wherein the commissures are affixed to the frame at a location proximal of the center of coaptation.

38. The valve prosthesis of claim 35 wherein the frame comprises a cell pattern and the commissures include flaps that span an entire area of at least one cell of the cell pattern.

39. The valve prosthesis of claim 35 wherein the skirt further comprises a plurality of end tabs adapted to be affixed to a proximal-most row of cells of the frame.

40. The valve prosthesis of claim 35 wherein the valve body is deployed supra-annularly of a patient'"'"'s aortic annulus when the valve prosthesis is delivered within a patient'"'"'s aortic valve and the frame is in the expanded deployed configuration.

41. The valve prosthesis of claim 35 wherein the frame is configured to hold a patient'"'"'s native valve permanently open in the expanded deployed configuration.

42. The valve prosthesis of claim 35 wherein the frame is configured to permit access to a patient'"'"'s coronary arteries in the expanded deployed configuration.

43. The valve prosthesis of claim 35 wherein frame has proximal and distal ends and a plurality of cell patterns that vary in size between the proximal and distal ends.

44. The valve prosthesis of claim 35 wherein the frame has, in the expanded deployed configuration, an enlarged outflow section with a first nominal diameter, a conical inflow section having a second nominal diameter and a constriction region having a third fixed diameter smaller than the first and second nominal diameters.

45. The valve prosthesis of claim 44 wherein the conical section has a proximal end and the conical section flares outward towards the proximal end.

46. The valve prosthesis of claim 44 wherein the constriction region comprises a plurality of cell patterns configured to provide a pre-determined radius of curvature for a transition from the constricted region to the outflow section.