Collapsible prosthetic heart valves

• US 9,351,828 B2
• Filed: 11/17/2015
• Issued: 05/31/2016
• 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., Figueiredo, Rubem L., Schraut, Julia A.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US14/943,521
• Publication Number:
  US 20160074159A1
• Time in Patent Office: 196 Days
• Field of Search: 623 21- 219
• US Class Current: 1/1
• 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 extending between an inflow end and an outflow end and including a plurality of struts, the inflow end having an inflow edge;

a plurality of leaflets disposed inside the supporting structure and operative to allow flow in an antegrade direction from the inflow end to the outflow end but to substantially block flow in a retrograde direction from the outflow end to the inflow end; and

a material disposed adjacent the inflow end of the supporting structure, the material extending from a luminal surface of the supporting structure, wrapping around the inflow edge and extending over a portion of the abluminal surface of the supporting structure so that the material includes a first portion disposed on the luminal surface of the supporting structure and a second portion disposed on the abluminal surface of the supporting structure, the first portion and the second portion being secured to selected struts of the supporting structure.

2. The valve defined in claim 1, wherein the plurality of leaflets includes three leaflets.

3. The valve defined in claim 1, wherein the struts define a plurality of cells.

4. The valve defined in claim 1, wherein the material comprises a fabric.

5. The valve defined in claim 1, wherein the first portion and the second portion comprise a single sheet folded at the inflow edge of the supporting structure.

6. The valve defined in claim 1, wherein the first portion extends a first distance from the inflow edge toward the outflow end of the supporting structure and the second portion extends a second distance from the inflow edge toward the outflow end of the supporting structure, the first distance and the second distance being equal.

7. The valve defined in claim 1, wherein the first portion extends a first distance from the inflow edge toward the outflow end of the supporting structure and the second portion extends a second distance from the inflow edge toward the outflow end of the supporting structure, the first distance and the second distance being unequal.

8. The valve defined in claim 1, wherein the first portion extends from the inflow edge further towards the outflow end of the supporting structure than the second portion.

9. The valve defined in claim 1, wherein the supporting structure includes a plurality of cells arranged in annular rows and the second portion extends over at least one full row of cells.

10. A prosthetic heart valve comprising:

an annularly collapsible and re-expandable supporting structure extending between an inflow end and an outflow end and including a plurality of struts, the inflow end having an inflow edge;

a plurality of leaflets disposed inside the supporting structure and operative to allow flow in an antegrade direction from the inflow end to the outflow end but to substantially block flow in a retrograde direction from the outflow end to the inflow end; and

at least one sheet of material disposed adjacent the inflow end of the supporting structure, the material extending from a luminal surface of the supporting structure, wrapping around the inflow edge, and extending over a portion of the abluminal surface of the supporting structure, the material including a first portion disposed on the luminal surface of the supporting structure and a second portion disposed on the abluminal surface of the supporting structure;

wherein the first portion and the second portion are coupled together at a top edge of the second portion.

11. The prosthetic heart valve defined in claim 10, wherein the at least one sheet is a single continuous sheet.

12. The valve defined in claim 10, wherein the plurality of leaflets includes three leaflets.

13. The valve defined in claim 10, wherein the struts define a plurality of cells.

14. The valve defined in claim 10, wherein the material comprises a fabric.

15. A prosthetic heart valve comprising:

an annularly collapsible and re-expandable supporting structure extending between an inflow end and an outflow end, the supporting structure including a plurality of cells arranged in annular rows and the inflow end having an inflow edge;

a plurality of leaflets disposed inside the supporting structure and operative to allow flow in an antegrade direction from the inflow end to the outflow end but to substantially block flow in a retrograde direction from the outflow end to the inflow end; and

a material disposed adjacent the inflow end of the supporting structure, the material extending from a luminal surface of the supporting structure, wrapping around the inflow edge and extending over a portion of the abluminal surface of the supporting structure, the material including a first portion disposed on the luminal surface of the supporting structure and a second portion disposed on the abluminal surface of the supporting structure;

wherein a top edge of the second portion is affixed to at least one of the supporting structure and the first portion so that the second portion extends over at least a portion of one of the cells with the portion of the one cell sandwiched between exactly two layers of material.

16. The valve defined in claim 15, further comprising a plurality of commissure features disposed on the supporting structure.

17. The valve defined in claim 15, wherein the plurality of leaflets includes three leaflets.

18. The valve defined in claim 15, wherein the material comprises a fabric.

19. The valve defined in claim 15, wherein the first portion and the second portion comprise a single sheet folded at the inflow edge of the supporting structure.

20. The valve defined in claim 15, wherein the first portion extends a first distance from the inflow edge toward the outflow end of the supporting structure and the second portion extends a second distance from the inflow edge toward the outflow end of the supporting structure, the first distance and the second distance being equal.

21. The valve defined in claim 15, wherein the first portion extends a first distance from the inflow edge toward the outflow end of the supporting structure and the second portion extends a second distance from the inflow edge toward the outflow end of the supporting structure, the first distance and the second distance being unequal.

22. The valve defined in claim 15, wherein the first portion extends from the inflow edge further towards the outflow end of the supporting structure than the second portion.

23. A prosthetic heart valve comprising:

an annularly collapsible and re-expandable supporting structure extending between an inflow end and an outflow end and including a plurality of struts, the inflow end having an inflow edge;

a plurality of leaflets disposed inside the supporting structure and operative to allow flow in an antegrade direction from the inflow end to the outflow end but to substantially block flow in a retrograde direction from the outflow end to the inflow end; and

a material disposed adjacent the inflow end of the supporting structure and including at least one section, the material extending from a luminal surface of the supporting structure, wrapping around the inflow edge, and extending over a portion of the abluminal surface of the supporting structure, the material including a first portion disposed on the luminal surface of the supporting structure and a second portion disposed on the abluminal surface of the supporting structure;

wherein the first portion and the second portion are sutured to selected struts of the supporting structure.

24. The valve defined in claim 23, wherein the material includes multiple sections.

25. The valve defined in claim 23, wherein the material includes three sections.

26. The valve defined in claim 23, wherein the plurality of leaflets includes three leaflets.

27. The valve defined in claim 23, wherein the struts define a plurality of cells.

28. The valve defined in claim 23, wherein the material comprises a fabric.

29. The valve defined in claim 23, wherein the first portion extends a first distance from the inflow edge toward the outflow end of the supporting structure and the second portion extends a second distance from the inflow edge toward the outflow end of the supporting structure, the first distance and the second distance being equal.

30. The valve defined in claim 23, wherein the first portion extends a first distance from the inflow edge toward the outflow end of the supporting structure and the second portion extends a second distance from the inflow edge toward the outflow end of the supporting structure, the first distance and the second distance being unequal.