Flexible heart valve leaflets

• US 6,338,740 B1
• Filed: 01/26/2000
• Issued: 01/15/2002
• Est. Priority Date: 01/26/1999
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Carpentier, Alain F.
• Primary Examiner(s): Snow, Bruce
• Assistant Examiner(s): Pellegrino, Brian E
• Application Number:
  US09/491,990
• Time in Patent Office: 720 Days
• Field of Search: 623/1.26, 623/2.1, 623/2.12, 623/2.13, 623/2.14, 623/2.17, 623/2.18, 623/904, 623/910, 623/929
• US Class Current: 623/2.13
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A heart valve with a structural stent and radially moveable cusps and commissures. The stent may be of three separate elements, each having a cusp portion and two commissure portions. The commissures may be pivotally or flexibly coupled, and may separate into independent leaflets. A connecting band may be provided that follows the cusps and commissures and extend outwardly. The valve may be connected to the natural tissue along the undulating connecting band. A multi-legged holder having legs alternating between each cusp and commissure may be used for implantation. A method of implantation is also disclosed, as is a system for implanting independent valve leaflets in the native annulus.

Claims

1. A method of surgically repairing a heart valve having multiple native leaflets located in a native annulus of a heart, comprising the steps of:

providing an independent prosthetic leaflet; and

,

replacing a single native leaflet with the independent prosthetic leaflet;

wherein the replacing step comprises positioning the independent prosthetic leaflet in the native annulus such that the independent prosthetic leaflet functions in conjunction with the remaining native leaflets to regulate blood flow through the annulus.

2. The method of claim 1, wherein the independent leaflet comprises a flexible body having an arcuate fixation edge defined by a cusp region and two commissure regions, and a coapting edge between the two commissure regions, and a flexible support attached along the fixation edge.

3. The leaflet of claim 2, wherein the flexible body is a biomaterial and the support comprises a strip of synthetic material.

4. The leaflet of claim 3, wherein the flexible body is made of bovine pericardium.

5. The method of claim 1, wherein the replacing step further comprises passing a plurality of staples through the independent leaflet and the native annulus.

6. The method of claim 5 wherein the staples are made of a shape memory material, the method further comprising the step of regulating the temperature of the staples to induce a temperature-induced shape change in the staples that causes the staples to bend.

7. The method of claim 6, further comprising the steps of:

providing an implantation device having a fluid circulation path; and

,

regulating the temperature of the fluid to regulate the temperature of the staples.

8. The method of claim 5, further comprising the step of bending the staples with an anvil.

9. A method of surgically repairing a heart valve having multiple native leaflets located in a native annulus of a heart, comprising:

providing a plurality of individual prosthetic leaflets; and

,

replacing the native leaflets with the plurality of individual prosthetic leaflets;

wherein the replacing step comprises sequentially and independently attaching each independent prosthetic leaflet to the native annulus.

10. The method of claim 9 wherein the number of individual prosthetic leaflets corresponds to the number of native leaflets.

11. The method of claim 9, wherein each independent leaflet comprises a flexible body having an arcuate fixation edge defined by a cusp region and two commissure regions, and a coapting edge between the two commissure regions, and a flexible support attached along the fixation edge.

12. The leaflet of claim 11, wherein the flexible body is a biomaterial and the support comprises a strip of synthetic material.

13. The leaflet of claim 12, wherein the flexible body is made of bovine pericardium.

14. The method of claim 9, wherein the replacing step further comprises passing a plurality of staples through the independent leaflet and the native annulus.

15. The method of claim 14 wherein the staples are made of a shape memory material, the method further comprising the step of regulating the temperature of the staples to induce a temperature-induced shape change in the staples that causes the staples to bend.

16. The method of claim 15, further comprising the steps of:

providing an implantation device having a fluid circulation path; and

,

regulating the temperature of the fluid to regulate the temperature of the staples.

17. The method of claim 14, further comprising the step of bending the staples with an anvil.

18. A method of surgically repairing a heart valve having multiple native leaflets located in a native annulus of a heart, comprising:

removing one or more, but not all, of the native leaflets;

providing a number of independent prosthetic leaflets corresponding to the number of removed native leaflets;

replacing the removed native leaflets with individual prosthetic leaflets;

wherein the replacing step comprises

sequentially and independently attaching each independent prosthetic leaflet to the native annulus; and

positioning the independent prosthetic leaflets in the annulus adjacent the remaining native leaflets such that the independent prosthetic leaflets function in conjunction with the remaining native leaflets to regulate blood flow through the annulus.

19. The method of claim 18, wherein each independent leaflet comprises a flexible body having an arcuate fixation edge defined by a cusp region and two commissure regions, and a coapting edge between the two commissure regions, and a flexible support attached along the fixation edge.

20. The leaflet of claim 19, wherein the flexible body is a biomaterial and the support comprises a strip of synthetic material.

21. The leaflet of claim 20, wherein the flexible body is made of bovine pericardium.

22. The method of claim 18, wherein the replacing step further comprises passing a plurality of staples through the independent leaflet and the native annulus.

23. The method of claim 22 wherein the staples are made of a shape memory material, the method further comprising the step of regulating the temperature of the staples to induce a temperature-induced shape change in the staples that causes the staples to bend.

24. The method of claim 23, further comprising the steps of:

providing an implantation device having a fluid circulation path; and

,

regulating the temperature of the fluid to regulate the temperature of the staples.

25. The method of claim 22, further comprising the step of bending the staples with an anvil.