Reinforced Commissural Support Structure

• US 20120095550A1
• Filed: 08/11/2011
• Published: 04/19/2012
• Est. Priority Date: 08/11/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Heart Leaflet Technologies, Inc. (Bracco SPA)
• Inventors: Gainor, John
• Granted Patent: US 8,696,737 B2
• Time in Patent Office: Days
• US Class Current: 623/2.14
• 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

Abstract

A device and method for controlling commissural tip deflection of a prosthetic valve, thereby both preventing failure due to repeated movement and/or uneven loading of the commissural points and also improving coaptation of the valve leaflets, including connecting reinforcing material between the commissural points so a spring-like span is created across the points. The spanning material may be in the form of a ring that is lashed, sewn or otherwise connected to the commissural points. The reinforcing material may form curved segments between the commissural points that extend outwardly to form sinuses behind the leaflets of the prosthetic valve. The reinforcing material may also extend in an upstream direction to avoid interfering with blood flowing out of the prosthetic valve.

Claims

1. A prosthetic valve comprising:

a support structure including a plurality of commissural points;

flexible material connected to said support structure to form valve leaflets between said commissural points;

reinforcement material spanning said commissural points.

2. The prosthetic valve of claim 1 wherein said support structure comprises a wireform.

3. The prosthetic valve of claim 2 wherein said flexible material comprises tissue.

4. The prosthetic valve of claim 3 wherein said tissue comprises biological tissue.

5. The prosthetic valve of claim 4 wherein said biological tissue comprises porcine tissue.

6. The prosthetic valve of claim 1 wherein said reinforcement material comprises a reinforcement ring that connects each of said commissural points.

7. The prosthetic valve of claim 6 wherein said reinforcement ring comprises a single wire ring.

8. The prosthetic valve of claim 1 wherein said reinforcement material comprises Nitinol.

9. The prosthetic valve of claim 6 wherein said reinforcement ring comprises a seamless loop cut from a tube.

10. The prosthetic valve of claim 1 wherein said reinforcement material comprises individual spanning members connected to and spanning between each of said commissural points.

11. The prosthetic valve of claim 1 wherein said reinforcement material spanning said commissural points does not extend downstream of said commissural points.

12. The prosthetic valve of claim 1 wherein said reinforcement material spanning said commissural points extends outward of said commissural points, thereby forming sinus spaces behind said valve leaflets.

13. A method of controlling flexure of a prosthetic valve having a plurality of commissural points comprising connecting said commissural points together with reinforcement material.

14. The method of claim 13 wherein connecting said commissural points together with reinforcement material comprises connecting a reinforcement ring to said commissural points.

15. The method of claim 13 wherein connecting said commissural points together with reinforcement material comprises connecting said commissural points with Nitinol reinforcements.

16. The method of claim 13 wherein connecting said commissural points together with reinforcement material comprises lashing said spanning reinforcements to each of said commissural points.

17. The method of claim 13 wherein connecting said commissural points together with reinforcement material comprises connecting said commissural points together with reinforcement material that does not extend downstream of said commissural points.

18. The method of claim 13 wherein connecting said commissural points together with reinforcement material comprises connecting said commissural points together with reinforcement material that extends outward of said commissural points, thereby forming sinus spaces behind said valve leaflets.

19. A method of controlling commissural tip deflection of a prosthetic valve having a plurality of commissural points comprising restricting inward movement of said commissural points.

20. The method of claim 19 wherein restricting inward movement of said commissural points comprises connecting said commissural points together with reinforcement material.

21. The method of claim 20 wherein connecting said commissural points together with reinforcement material comprises connecting a reinforcement ring to said commissural points.

22. The method of claim 20 wherein connecting said commissural points together with reinforcement material comprises connecting said commissural points with Nitinol reinforcements.

23. The method of claim 20 wherein connecting said commissural points together with reinforcement material comprises lashing said spanning reinforcements to each of said commissural points.

24. The method of claim 21 wherein connecting a reinforcement ring to said commissural points comprises lashing a reinforcement ring to said commissural points.

25. The method of claim 20 wherein connecting said commissural points together with reinforcement material comprises connecting said commissural points together with reinforcement material that does not extend downstream of said commissural points.

26. The method of claim 20 wherein connecting said commissural points together with reinforcement material comprises connecting said commissural points together with reinforcement material that extends outward of said commissural points, thereby forming sinus spaces behind said valve leaflets.