Reinforced commissural support structure

• US 8,696,737 B2
• Filed: 08/11/2011
• Issued: 04/15/2014
• Est. Priority Date: 08/11/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: HLT, Inc. (Bracco SPA)
• Inventors: Gainor, John
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): BARIA, DINAH N
• Application Number:
  US13/208,236
• Publication Number:
  US 20120095550A1
• Time in Patent Office: 978 Days
• Field of Search: 623/1.24, 623/2.1, 623/2.14, 623/2.18, 623/1.26
• US Class Current: 623/1.24
• 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:

an annular wireform connected to a downstream portion of a support structure, said wireform including a plurality of commissural points and defining a central longitudinal axis;

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

reinforcement material connected to and spanning between said commissural points, said reinforcement material controlling flexure of said commissural points;

wherein said reinforcement material spanning said commissural points extends radially outwardly of said commissural points, thereby defining sinus spaces radially outwardly of said valve leaflets.

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

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 6 wherein said reinforcement ring comprises a seamless loop cut from a tube.

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

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

11. A method of controlling flexure of a prosthetic valve comprising:

providing a prosthetic valve having an annular wireform defining a plurality of commissural points and a central longitudinal axis, said wireform supporting valve material and forming said valve material into said prosthetic valve;

connecting said commissural points together with reinforcement material extending radially outwardly of said commissural points.

12. The method of claim 11 wherein connecting said commissural points together with reinforcement material comprises connecting a reinforcement ring to said commissural points.

13. The method of claim 11 wherein connecting said commissural points together with reinforcement material comprises connecting said commissural points with Nitinol reinforcements.

14. The method of claim 11 wherein connecting said commissural points together with reinforcement material comprises lashing said reinforcements to each of said commissural points.

15. The method of claim 11 wherein connecting said commissural points together with reinforcement material comprises defining sinus spaces proximate radially outward of said valve leaflets.

16. A method of controlling commissural tip deflection of a prosthetic valve assembly comprising:

providing a prosthetic valve assembly, said assembly including a braided support structure, an annular wireform defining a central longitudinal axis and attached to an end of said braided support structure and having a plurality of commissural points, and a flexible material attached to said wireform to form a prosthetic valve;

allowing a limited amount of inward flexure of said commissural points by connecting said commissural points together with reinforcement material that extends radially outwardly from said commissural points.

17. The method of claim 16 wherein connecting said commissural points together with reinforcement material comprises connecting a reinforcement ring to said commissural points.

18. The method of claim 17 wherein connecting a reinforcement ring to said commissural points comprises lashing a reinforcement ring to said commissural points.

19. The method of claim 16 wherein connecting said commissural points together with reinforcement material comprises connecting said commissural points with Nitinol reinforcements.

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

21. The method of claim 16 wherein connecting said commissural points together defines sinus spaces radially outward of said valve leaflets.