Collapsible prosthetic heart valves

• US 9,545,307 B2
• Filed: 03/24/2016
• Issued: 01/17/2017
• 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:
  US15/079,244
• Publication Number:
  US 20160199183A1
• Time in Patent Office: 299 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

A prosthetic heart valve includes 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, a first material disposed on a luminal surface of the supporting structure adjacent the inflow end, and a second material disposed on an abluminal surface of the supporting structure adjacent the inflow end, the first material and the second material being secured to selected struts of the supporting structure, and separately secured to each other adjacent the inflow edge.

Claims

1. 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;

an inner portion disposed on a luminal surface of the supporting structure adjacent the inflow end; and

an outer portion disposed on an abluminal surface of the supporting structure adjacent the inflow end;

wherein a portion of a top edge of the outer portion is affixed to the inner portion, a bottom edge of the outer portion is affixed to the inner portion, and at least one of the inner and outer portions overlays the inflow edge of the supporting structure.

2. The valve of claim 1, further comprising a plurality of commissure features disposed on the supporting structure.

3. The valve of claim 1, wherein the plurality of leaflets includes three leaflets.

4. The valve of claim 1, wherein the outer portion comprises a fabric.

5. The valve of claim 1, wherein the supporting structure includes a balloon-expandable stent.

6. The valve of claim 1, wherein the inner portion extends a first distance from the inflow edge toward the outflow end of the supporting structure and the outer 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 of claim 1, wherein the inner portion extends a first distance from the inflow edge toward the outflow end of the supporting structure and the outer 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 of claim 1, wherein the inner portion extends from the inflow edge further towards the outflow end of the supporting structure than the outer portion.

9. 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;

an outer layer contacting an exterior of the supporting structure; and

an inner layer contacting an interior of the supporting structure, the inner layer and the outer layer being sutured to the supporting structure, the inner layer being sutured to the outer layer adjacent the inflow edge of the supporting structure, and the inner layer being further sutured to the plurality of leaflets, the inner and outer layers enveloping the inflow edge of the supporting structure.

10. The valve of claim 9, wherein the inner layer is sutured to the outer layer at the inflow edge.

11. The valve of claim 9, wherein the inner layer and the outer layer wrap around the inflow edge of the supporting structure.

12. The valve of claim 9, wherein the plurality of leaflets includes three leaflets.

13. The valve of claim 9, wherein the struts define a plurality of cells.

14. The valve of claim 9, wherein the outer layer comprises a fabric.

15. The valve of claim 9, wherein the inner layer extends a first distance from the inflow edge toward the outflow end of the supporting structure and the outer layer 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.

16. The valve of claim 9, wherein the inner layer extends a first distance from the inflow edge toward the outflow end of the supporting structure and the outer layer 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.