Collapsible prosthetic heart valves

• US 8,425,593 B2
• Filed: 09/26/2008
• Issued: 04/23/2013
• Est. Priority Date: 09/26/2007
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N., McCarthy, Andrea L., Neuman, Julia A., Figueiredo, Rubem L.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US12/733,759
• Publication Number:
  US 20100185277A1
• Time in Patent Office: 1,670 Days
• Field of Search: 623 21- 219
• US Class Current: 623/2.17
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2230/0006 circular
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

Prosthetic heart valves, which are collapsible to a relatively small circumferential size for less invasive delivery into a patient and which then re-expand to operating size at an implant site in the patient, include a collapsible/expandable stent-like supporting structure and various components of flexible, sheet-like material that are attached to the supporting structure. For example, these sheet-like other components may include prosthetic valve leaflets, layers of buffering material, cuff material, etc. Improved structures and techniques are provided for securing such other components to the stent-like supporting structure of the valve.

Claims

1. A prosthetic heart valve comprising:

an annularly collapsible and re-expandable supporting structure;

a sheet-like, flexible, leaflet mounted inside the supporting structure so that a free edge portion of the leaflet forms a flexible chord across an interior of the supporting structure, material of the leaflet beyond an end of the chord forming a flap that is folded to lie, at least in part, in a cylindrical surface defined by one of the inner and outer surfaces of the supporting structure;

and a sheet-like, flexible, buffer material between the supporting structure and the leaflet.

2. The valve defined in claim 1 wherein the flap is secured to the supporting structure.

3. The valve defined in claim 2 wherein the flap is sutured to the supporting structure to secure the flap to the supporting structure.

4. The valve defined in claim 1 wherein the flap lies, at least in part, in the cylindrical surface defined by the inner surface of the supporting structure.

5. The valve defined in claim 1 wherein the flap passes through the supporting structure to lie, at least in part, in the cylindrical surface defined by the outer surface of the supporting structure.

6. The valve defined in claim 1 further comprising:

a reinforced core for cooperating with the leaflet and a suture to secure the leaflet to the supporting structure.

7. The valve defined in claim 3 further comprising:

a reinforced core for cooperating with the flap and a suture to secure the flap to the supporting structure.

8. The valve defined in claim 1 wherein the leaflet has a secured line portion which is spaced from the free edge portion across an intervening belly portion of the leaflet, the secured line portion being secured to the supporting structure, and additional material of the leaflet beyond the secured line portion in a direction away from the belly portion forming a second flap that is folded to lie, at least in part, in a cylindrical surface defined by one of the inner and outer surfaces of the supporting structure.

9. The valve defined in claim 8 wherein the second flap is folded toward the free edge portion and secured to the supporting structure inside the supporting structure.

10. The valve defined in claim 8 wherein the second flap is folded away from the free edge portion and secured to the supporting structure inside the supporting structure.

11. The valve defined in claim 10 wherein the second flap continues beyond an axial end of the supporting structure and is additionally folded over that axial end and back outside of the supporting structure for additional securement to the outside of the supporting structure.

12. The valve defined in claim 8 further comprising:

a reinforced core for cooperating with the second flap and a suture to secure the second flap to the supporting structure.

13. The valve defined in claim 1 wherein the supporting structure comprises:

a plurality of annularly spaced commissure posts, and wherein the flap is secured to an associated one of the commissure posts.

14. The valve defined in claim 13 wherein the flap is secured to the associated commissure post by suture material that passes through the flap and apertures through the associated commissure post.

15. The valve defined in claim 13 wherein the flap is folded around the associated commissure post.

16. The valve defined in claim 13 wherein the associated commissure post is bifurcated into two spaced apart members, and wherein the flap passes through the commissure post between the two members.

17. The valve defined in claim 13 wherein at least part of each commissure post is cantilevered from other structure of the supporting structure.

18. The valve defined in claim 1 wherein the supporting structure comprises:

a plurality of annular, annularly collapsible and re-expandable substructures that are spaced from one another along an axis about which the supporting structure is annular; and

a plurality of linking members that are substantially parallel to the axis and that interconnect the substructures without the linking members deforming when the substructures annularly collapse and re-expand.

19. A leaflet structure for a prosthetic heart valve comprising:

a sheet of flexible leaflet material having a central opening with three sides, each of the sides being shaped to form the free edge of a respective one of three operating leaflet portions of the leaflet structure, the sheet additionally having three secured line portions, each secured line portion being radially outward from a respective, associated one of the free edges, and each secured line portion being arcuate so that it is radially farther from a midpoint of the associated free edge than from endpoints of the associated free edge, wherein the sheet continues radially outwardly beyond at least a portion of at least one of the secured line portions to form a flap.

20. The structure defined in claim 19 wherein the sheet defines three leaflet-linking areas, each leaflet-linking area extending radially outwardly from a junction of a respective pair of the free edges to a junction of the secured line portions that are radially outward from the free edges in the pair.

21. The structure defined in claim 20 wherein the sheet defines a flap that extends into the central opening from at least one of the leaflet-linking areas.

22. The structure defined in claim 20 wherein each of the free edges has opposite ends, and each of the free edges is curved radially inwardly into the central opening between its opposite ends.

23. A prosthetic heart valve comprising:

an annular, annularly collapsible and re-expandable supporting structure; and

the sheet of flexible leaflet material defined in claim 20 disposed in the supporting structure with the secured line portions and the leaflet-linking areas secured to the supporting structure so that the free edges can come together in the interior of the supporting structure.

24. The valve defined in claim 23 wherein the supporting structure comprises:

three annularly spaced commissure posts, and wherein each of the leaflet-linking areas is secured to a respective one of the commissure posts.

25. The valve defined in claim 24 wherein at least one of the leaflet-linking areas passes outside the supporting structure at the commissure post to which the at least one leaflet-linking area is secured.

26. The valve defined in claim 24 wherein at least one of the commissure posts is bifurcated into two spaced apart members, and wherein each leaflet-linking area passes between the two members of a respective commissure post.

27. The valve defined in claim 23 wherein the sheet continues radially outwardly beyond at least a portion of at least one of the secured line portions to form a flap, and wherein the flap is secured to the supporting structure.

28. The valve defined in claim 27 wherein the flap is secured inside the supporting structure.

29. The valve defined in claim 27 wherein the flap is secured outside the supporting structure.

30. The valve defined in claim 23 further comprising:

sheet-like, flexible, buffer material between the supporting structure and the leaflet material.

31. The valve defined in claim 24 wherein each of the commissure posts is at least partly cantilevered from other structure of the supporting structure.

32. A prosthetic heart valve comprising:

an annular, annularly collapsible and re-expandable supporting structure, the supporting structure including a plurality of members disposed in a zig-zag pattern that extends in a direction that is annular of the supporting structure, at least two of the members meeting at an apex that points away from the supporting structure parallel to an axis about which the supporting structure is annular;

a sheet of flexible material secured to the supporting structure; and

a plurality of flexible leaflets disposed inside the supporting structure and at least partly secured to the sheet, wherein the sheet is at least partly secured to the supporting structure via a suture attachment at the apex, and the apex includes an eyelet through which the suture attachment passes, and wherein the apex includes an enlarged head on the end of a reduced neck that extends in the direction in which the apex points, and wherein the suture attachment is wound around the neck.

33. A prosthetic heart valve comprising:

an annular, annularly collapsible and re-expandable supporting structure, the supporting structure including a plurality of members disposed in a zig-zag pattern that extends in a direction that is annular of the supporting structure, at least two of the members meeting at an apex that points away from the supporting structure parallel to an axis about which the supporting structure is annular;

a sheet of flexible material secured to the supporting structure; and

a plurality of flexible leaflets disposed inside the supporting structure and at least partly secured to the sheet, wherein the sheet is at least partly secured to the supporting structure via a suture attachment at the apex, and wherein the apex is shaped to prevent the suture attachment from moving away from the apex in a direction opposite to a direction in which the apex points, wherein the apex comprises a notch that opens in the direction in which the apex points, and wherein the suture attachment is wound around the inside of the apex and the inside of the notch.

34. The valve defined in claim 33 wherein the notch is narrowed near its entrance to form an open eyelet.

35. The valve defined in claim 34 wherein the eyelet is too small for passage of a suture needle, but the entrance is large enough for suture material to slip through.