Heart Valve Prosthesis and Methods of Manufacture and Use

• US 20110172765A1
• Filed: 03/25/2011
• Published: 07/14/2011
• Est. Priority Date: 05/13/2005
• Status: Active Grant

• Current Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Original Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Inventors: Nguyen, Than, Nguyen, Mykim, Michiels, Robrecht, Komatsu, Stanley, Nguyen, Hung
• Granted Patent: US 8,226,710 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• 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 2230/0054 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 valve body comprising a plurality of leaflets affixed to a skirt, adjoining leaflets affixed together to form commissures; and

a frame supporting the valve body, the frame having a longitudinal axis,

wherein the commissures are affixed to the frame along a region of the frame that increases in diameter along the longitudinal axis,

wherein the commissures are longitudinally offset from the center of coaptation, and each leaflet has a free edge that is suspended from the leaflet'"'"'s respective commissures to define coaptation edges and a center of coaptation, and

wherein the length of each free edge forms a substantially continuous curve extending downwardly between the respective commissures so that the free edges of the leaflets generally define the shape of catenaries to substantially uniformly distribute loads over the leaflets.

2. The valve prosthesis of claim 1, wherein the catenaries are configured to reduce horizontal loads applied to the commissures.

3. The valve prosthesis of claim 1, 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.

4. The valve prosthesis of claim 1, wherein the skirt further comprises a plurality of longitudinally-oriented reinforcing tabs.

5. The valve prosthesis of claim 1, wherein the leaflets comprise porcine, bovine, equine or other mammalian pericardial tissue, synthetic material, or polymeric material.

6. The valve prosthesis of claim 1, wherein the frame is self expanding, and 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 frame.

7. The valve prosthesis of claim 6, wherein the frame further comprises a cell pattern that defines a contour configured to support the joints.

8. The valve prosthesis of claim 4, wherein the frame is self expanding, and wherein and the reinforcing tabs are affixed to the frame.

9. The valve prosthesis of claim 1, wherein the frame is self expanding, and wherein the frame has a contracted delivery configuration and an expanded deployed configuration.

10. The valve prosthesis of claim 9, wherein the frame comprises a cell pattern defined by unequal length zig-zags.

11. The valve prosthesis of claim 9, wherein the commissures are affixed to the frame at a location proximal of the center of coaptation.

12. The valve prosthesis of claim 9, 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.

13. The valve prosthesis of claim 9, wherein the skirt further comprises a plurality of end tabs adapted to be affixed to a proximal-most row of cells of the frame.

14. The valve prosthesis of claim 9, wherein the valve body is deployed superannularly 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.

15. The valve prosthesis of claim 9, wherein the frame is configured to hold a patient'"'"'s native valve permanently open in the expanded deployed configuration.

16. The valve prosthesis of claim 9, wherein the frame is configured to permit access to a patient'"'"'s coronary arteries in the expanded deployed configuration.

17. The valve prosthesis of claim 9, wherein the frame has proximal and distal ends and a plurality of cell patterns that vary in size between the proximal and distal ends.

18. The valve prosthesis of claim 9, 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.

19. The valve prosthesis of claim 18, wherein the conical section has a proximal end and the conical section flares outward towards the proximal end.

20. The valve prosthesis of claim 18, 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.

21. The valve prosthesis of claim 18, wherein the third fixed diameter is a predetermined diameter.

22. The valve prosthesis of claim 1, wherein, when the valve is in the closed position, the length of each free edge forms a substantially continuous curve extending downwardly between the respective commissures so that the free edges of the leaflets generally define the shape of catenaries to substantially uniformly distribute loads over the leaflets.

23. A valve prosthesis comprising:

a valve body comprising three leaflets, wherein adjoining leaflets are sewn together to form commissures; and

a self-expanding frame, the frame having an inflow section having a first row of cells, an outflow section having a second row of cells and including an eyelet, and a middle region between the inflow section and the outflow section, wherein the middle region is configured to avoid blocking blood flow to the coronary arteries when the frame is implanted in a body, wherein the area of individual cells in the first row of cells is less than the area of individual cells in the second row of cells,

wherein the frame supports the valve body, wherein the frame has a longitudinal axis, wherein the frame has a contracted delivery configuration and an expanded deployed configuration,

wherein, when the frame is in the expanded deployed configuration, the outflow section has a larger diameter than the inflow section,

wherein a plurality of cells of the frame are positioned between the cells spanned by commissures,

wherein each leaflet has a free edge that is suspended from the leaflet'"'"'s commissures to define coaptation edges and a center of coaptation, and

wherein the length of each free edge forms a substantially continuous curve extending downwardly between the respective commissures so that the free edges of the leaflets generally define the shape of catenaries to substantially uniformly distribute loads over the leaflets.

24. The valve prosthesis of claim 23, wherein the leaflets comprise porcine, bovine, equine or other mammalian pericardial tissue, synthetic material, or polymeric material.

25. The valve prosthesis of claim 23, wherein the leaflets are sewn to a skirt at joints, wherein the skirt is sewn to the inflow section of the frame, and wherein the joints are affixed to the frame to evenly distribute forces through the valve body to the frame.

26. The valve prosthesis of claim 25, wherein the frame further comprises a cell pattern that defines a contour configured to support the joints.

27. The valve prosthesis of claim 23, wherein the frame comprises a cell pattern defined by unequal length zig-zags.

28. The valve prosthesis of claim 23, wherein the commissures are affixed to the frame at a location proximal of the center of coaptation.

29. The valve prosthesis of claim 23, wherein the commissures include flaps that span an entire area a cell.

30. The valve prosthesis of claim 23, wherein the frame is configured to permit access to a patients coronary arteries in the expanded deployed configuration.

31. The valve prosthesis of claim 23, wherein at least one cell in the outflow section is larger than at least one cell in the inflow section.

32. The valve prosthesis of claim 23, wherein a cell in the outflow section has a first area, wherein a cell in the inflow section has a second area, and wherein the first area is larger than the second area.

33. The valve prosthesis of claim 23, wherein the inflow section includes a first row of cells, wherein the outflow section includes a second row of cells, and wherein the number of cells in the first row of cells is equal to the number of cells in the second row of cells.

34. The valve prosthesis of claim 23, wherein the middle region and the outflow section comprise a cell pattern that provides a pre-determined radius of curvature for a transition from the middle region to the outflow section when the frame is in the expanded deployed configuration.

35. The valve prosthesis of claim 23, wherein the diameter of the constriction region is less than the diameter of the inflow section.

36. The valve prosthesis of claim 23, wherein the outflow section includes exactly three eyelets.

37. The valve prosthesis of claim 23, wherein the frame includes four rows of cells.

38. A valve prosthesis comprising:

a valve body comprising three leaflets, wherein adjoining leaflets are sewn together to form commissures; and

a self-expanding frame comprising a plurality of cells, the frame having an inflow section, an outflow section, and a middle region between the inflow section and the outflow section, wherein the middle region is configured to avoid blocking blood flow to the coronary arteries when the frame is implanted in a body,

wherein the frame supports the valve body, wherein the frame has a longitudinal axis, wherein the frame has a contracted delivery configuration and an expanded deployed configuration,

wherein, when the frame is in the expanded deployed configuration, the outflow section has a larger diameter than the inflow section,

wherein each commissure is configured to span a cell of the frame to distribute force within the commissures and to the frame, and wherein a plurality of cells of the frame are positioned between the cells spanned by commissures,

wherein each leaflet has a free edge that is suspended from the leaflet'"'"'s commissures to define coaptation edges and a center of coaptation, and

wherein the length of each free edge forms a substantially continuous curve extending downwardly between the respective commissures so that the free edges of the leaflets generally define the shape of catenaries to substantially uniformly distribute loads over the leaflets.