Techniques for attaching flexible leaflets of prosthetic heart valves to supporting structures

• US 8,409,274 B2
• Filed: 04/26/2007
• Issued: 04/02/2013
• Est. Priority Date: 04/26/2007
• Status: Expired due to Fees

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Li, XueMei, Woo, Yi-Ren
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US11/796,471
• Publication Number:
  US 20130018456A1
• Time in Patent Office: 2,168 Days
• Field of Search: 623/2.1, 623/2.17, 623/2.38, 623/1.15, 623/1.24, 623 211- 215, 623/2.41, 623/2.18, 606/151
• US Class Current: 623/2.17
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents

Abstract

A prosthetic heart valve has an annular valve-perimeter-shape-defining structure having a radially outer surface. A clip structure is provided on the outer surface. This clip structure is used to attach flexible valve leaflets to the shape-defining structure. One or more retainer members may be used to help hold the leaflets in the clip structure.

Claims

1. A prosthetic heart valve comprising:

an annular valve-perimeter shape-defining structure having a radially outer surface;

a clip structure on the outer surface, the clip structure having a cam which may be influenced to move the clip structure from a natural closed condition to an open condition;

a retainer member; and

a flexible leaflet having an edge portion that is folded over the retainer member, the retainer member and the edge portion being received in the clip structure in said open condition of said clip structure by influence on said cam, and the retainer member and the edge portion being retained in the clip structure by said cam in said closed condition of said clip structure.

2. The valve defined in claim 1 wherein the valve-perimeter-shape-defining structure includes a pair of annularly spaced commissure regions, and wherein the clip structure includes a plurality of portions that are spaced from one another along the valve-perimeter-shape-defining structure from adjacent one of the commissure regions to adjacent the other of the commissure regions.

3. The valve defined in claim 1 wherein the valve-perimeter-shape-defining structure includes a pair of annularly spaced commissure regions, and wherein the retainer member extends continuously from adjacent one of the commissure regions to adjacent the other of the commissure regions.

4. The valve defined in claim 1 wherein the valve-perimeter-shape-defining structure includes a pair of annularly spaced commissure regions, and wherein the clip structure extends more than half of the distance from adjacent one of the commissure regions to adjacent the other of the commissure regions.

5. The valve defined in claim 1 wherein the valve-perimeter-shape-defining structure includes a blood-inflow edge and a blood-outflow edge, and wherein the clip structure is open in a direction toward the blood-inflow edge and can be entered by the retainer member and the edge portion from a side of the clip structure that is toward the blood-inflow edge.

6. The valve defined in claim 1 wherein the valve-perimeter-shape-defining structure includes a blood-inflow edge and a blood-outflow edge, and wherein the leaflet extends from the clip structure, around the blood-inflow edge, and into a space that is surrounded by the valve-perimeter-shape-defining structure.

7. The valve defined in claim 1 wherein the valve-perimeter-shape-defining structure includes a blood-inflow edge and a blood-outflow edge, and wherein the clip structure is open in a direction toward the blood-outflow edge and can be entered by the retainer member and the edge portion from a side of the clip structure that is toward the blood-outflow edge.

8. The valve defined in claim 1 wherein the valve-perimeter-shape-defining structure includes a blood-inflow edge and a blood-outflow edge, and wherein the leaflet extends from the clip structure, over the blood-outflow edge, and toward an axis about which the valve-perimeter-shape-defining structure is annular.

9. The valve defined in claim 1 further comprising a cover over a radially outer surface of the clip structure.

10. The valve defined in claim 9 wherein the cover is adapted for sutures to be passed through in order to suture the valve into a patient.

26. The valve defined in claim 1 wherein the clip structure is attached to the annular valve-perimeter shape-defining structure, and the clip structure has a base portion that projects radially out from the annular valve-perimeter shape-defining structure.

29. The valve defined in claim 1 wherein the clip structure has a free end that projects from the base portion back toward the annular valve-perimeter shape-defining structure.

32. The valve defined in claim 4 wherein the valve-perimeter-shape-defining structure includes a pair of annularly spaced commissure regions, and wherein the clip structure extends continuously from adjacent one of the commissure regions to adjacent the other of the commissure regions.

11. A prosthetic heart valve comprising:

an annular valve-perimeter-shape-defining structure having a radially outer surface;

a clip structure on the outer surface, the clip structure having an open state and a closed state defined by movement of a cam element; and

a flexible leaflet having an edge portion that is at least partly secured to the valve-perimeter-shape-defining structure by being retained in the clip structure by the cam element when in said closed state.

12. The valve defined in claim 11 further comprising:

a retainer member disposed in the clip structure with the edge portion to help the clip structure retain the leaflet.

13. The valve defined in claim 12 wherein the edge portion is folded over the retainer member in the clip structure.

14. The valve defined in claim 11 wherein the valve-perimeter-shape-defining structure includes a pair of annularly spaced commissure regions, and wherein the clip structure includes a plurality of portions that are spaced from one another along the valve-perimeter-shape-defining structure from adjacent one of the commissure regions to adjacent the other of the commissure regions.

15. The valve defined in claim 11 wherein the valve-perimeter-shape-defining structure includes a pair of annularly spaced commissure regions, and wherein a retainer member extends continuously from adjacent one of the commissure regions to adjacent the other of the commissure regions.

16. The valve defined in claim 11 wherein the valve-perimeter-shape-defining structure includes a pair of annularly spaced commissure regions, and wherein the clip structure extends more than half of the distance from adjacent one of the commissure regions to adjacent the other of the commissure regions.

17. The valve defined in claim 11 wherein the valve-perimeter-shape-defining structure includes a blood-inflow edge and a blood-outflow edge, and wherein the clip structure is open in a direction toward the blood-inflow edge and can be entered by the edge portion from a side of the clip structure that is toward the blood-inflow edge.

18. The valve defined in claim 11 wherein the valve-perimeter-shape-defining structure includes a blood-inflow edge and a blood-outflow edge, and wherein the leaflet extends from the clip structure, around the blood-inflow edge, and into a space that is surrounded by the valve-perimeter-shape-defining structure.

19. The valve defined in claim 11 wherein the valve-perimeter-shape-defining structure includes a blood-inflow edge and a blood-outflow edge, and wherein the clip structure is open in a direction toward the blood-outflow edge and can be entered by the edge portion from a side of the clip structure that is toward the blood-outflow edge.

20. The valve defined in claim 11 wherein the valve-perimeter-shape-defining structure includes a blood-inflow edge and a blood-outflow edge, and wherein the leaflet extends from the clip structure, over the blood-outflow edge, and toward an axis about which the valve-perimeter-shape-defining structure is annular.

21. The valve defined in claim 11 further comprising:

a cover over a radially outer surface of the clip structure.

22. The valve defined in claim 11 further comprising:

a sewing cuff attached to an outside of at least a portion of the outer surface.

27. The valve defined in claim 11 wherein the clip structure is attached to the annular valve-perimeter shape-defining structure, and the clip structure has a base portion that projects radially out from the annular valve-perimeter shape-defining structure.

30. The valve defined in claim 11 wherein the clip structure has a free end that projects from the base portion back toward the annular valve-perimeter shape-defining structure.

33. The valve defined in claim 16 wherein the valve-perimeter-shape-defining structure includes a pair of annularly spaced commissure regions, and wherein the clip structure extends continuously from adjacent one of the commissure regions to adjacent the other of the commissure regions.

23. A method of making a prosthetic heart valve comprising:

providing an annular valve-perimeter shape-defining structure having a radially outer surface on which a clip structure is provided, the clip structure having an open condition and a closed condition, the open condition being obtained by influence on a cam surface of the clip structure;

folding an edge portion of a leaflet over a retainer member; and

inserting the edge portion and the retainer member into the clip structure against the cam surface to move the clip structure into said open condition;

securing the leaflet to the valve-perimeter-shape-defining structure when the clip structure is in the closed condition.

24. The method defined in claim 23 wherein the valve-perimeter-shape-defining structure is annular about a central longitudinal axis, wherein the valve perimeter-shape-defining structure includes first and second end edges that face away from one another in opposite directions along the central longitudinal axis, and wherein the method further comprises:

folding the leaflet over one of the end edges and inwardly of the valve-perimeter-shape defining structure toward the central longitudinal axis.

25. The method defined in claim 23 further comprising:

attaching a sewing cuff to an outside of at least a portion of the outer surface.

28. The method defined in claim 23 wherein the clip structure is attached to the annular valve-perimeter shape-defining structure, and the clip structure has a base portion that projects radially out from the annular valve-perimeter shape-defining structure.

31. The method defined in claim 23 wherein the clip structure has a free end that projects from the base portion back toward the annular valve-perimeter shape-defining structure.