Leaflet in configuration for function in various shapes and sizes

• US 10,722,350 B2
• Filed: 12/13/2016
• Issued: 07/28/2020
• Est. Priority Date: 06/28/2012
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N., Ahmann, Katherine A., Fahim, Mina S., Allison, Jeffrey J., McCarthy, Andrea L.
• Primary Examiner(s): Lopez, Leslie
• Application Number:
  US15/376,905
• Publication Number:
  US 20170086972A1
• Time in Patent Office: 1,323 Days
• 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
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• 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 2250/0017 differing in yarn density
• CPC Class Codes: F04C 2270/0421 Controlled or regulated

Abstract

A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end. The heart valve further includes a plurality of commissure features disposed on the stent, and a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to the plurality of commissure features, each of the plurality of leaflets having a free edge and being configured to have a tension line aligned near the free edge to prevent backflow.

Claims

1. A prosthetic heart valve, comprising:

a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end, an aortic section adjacent the distal end, and a plurality of commis sure features disposed on the stent;

a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to the plurality of commissure features, each of the plurality of leaflets having a body portion, a free edge adapted to coapt with free edges of adjacent leaflets, and an attachment portion opposite each free edge;

a cuff disposed on a surface of the stent;

a plurality of reinforcements formed of at least one of a cord, a wire and a strip of fabric, each reinforcement being coupled to a respective attachment portion of each of the plurality of leaflets and being separate from the respective attachment portion in a transverse cross-section; and

a first suture pattern coupling the reinforcement to the attachment portion by looping around the reinforcement such that each reinforcement is positioned radially between the body portion of one of the plurality of leaflets and the cuff.

2. The prosthetic heart valve of claim 1, wherein the first suture pattern includes a reverse-running stitch that passes through each attachment portion and the reinforcement.

3. The prosthetic heart valve of claim 1, further comprising a second suture pattern coupling each attachment portion to at least one of the stent and the cuff.

4. The prosthetic heart valve of claim 3, wherein the second suture pattern wraps around the reinforcement.

5. The prosthetic heart valve of claim 3, wherein the second suture pattern pierces the reinforcement.

6. The prosthetic heart valve of claim 3, wherein the second suture pattern overlaps with the first suture pattern.

7. The prosthetic heart valve of claim 3, wherein the second suture pattern couples each attachment portion to the stent.

8. The prosthetic heart valve of claim 3, wherein the second suture pattern couples the attachment portion to the cuff.

9. The prosthetic heart valve of claim 3, wherein the second suture pattern and the first suture pattern are different from each other.

10. The prosthetic heart valve of claim 1, wherein the reinforcement is disposed between tabs of each of the leaflets.

11. The prosthetic heart valve of claim 1, wherein the reinforcement comprises at least one of the cord and the wire.

12. The prosthetic heart valve of claim 1, wherein the reinforcement comprises the strip of fabric.

13. A method of forming a prosthetic heart valve, comprising:

providing a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end, an aortic section adjacent the distal end, a lumen extending from the proximal end to the distal end, and a plurality of commissure features, the stent having a cuff disposed on a surface of the stent;

providing a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to the plurality of commis sure features, each of the plurality of leaflets having a free edge adapted to coapt with free edges of adjacent leaflets, a body portion, and an attachment portion opposite the free edge;

providing a reinforcement formed of at least one of a cord, a wire and a strip of fabric; and

coupling the reinforcement to the attachment portion of one leaflet using a first suture pattern by looping around the reinforcement such that the reinforcement is separate from the respective attachment portion in a transverse cross-section and such that each reinforcement is positioned radially between the body portion of one of the plurality of leaflets and the cuff.

14. The method claim 13, wherein coupling the reinforcement includes forming a reverse-running stitch.

15. The method claim 13, further comprising the step of coupling the attachment portion to at least one of the stent and the cuff using a second suture pattern.

16. The method claim 15, wherein coupling the attachment portion to at least one of the stent and the cuff comprises wrapping the second suture pattern around the reinforcement.

17. The method claim 15, wherein coupling the attachment portion to at least one of the stent and the cuff comprises piercing the reinforcement with the second suture pattern.

18. The method claim 15, wherein coupling the attachment portion to at least one of the stent and the cuff comprises overlapping the second suture pattern with the first suture pattern.

19. The method claim 13, wherein providing a reinforcement comprises providing at least one of the cord and the wire.

20. The method claim 13, wherein providing a reinforcement comprises providing the strip of fabric.