Heart valve with integrated stent and sewing ring

• US 10,238,486 B2
• Filed: 09/09/2016
• Issued: 03/26/2019
• Est. Priority Date: 06/01/2000
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Huynh, Van, Scott, Michael J., Johnson, Derrick
• Primary Examiner(s): Schall, Matthew
• Application Number:
  US15/261,468
• Publication Number:
  US 20170086970A1
• Time in Patent Office: 928 Days
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• 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 2230/0067 conical

Abstract

A sewing ring for prosthetic heart valves that is connected and configured to pivot outward. A biocompatible fabric covering surrounds at least a portion of the sewing ring, and the ring may be exclusively connected to a stent with the fabric. The sewing ring may be generally planar and of uniform thickness, or may be of varying thickness. The fabric may be used to encompass both the stent and the sewing ring, and may be a single piece. A seam may be provided in the fabric as a discrete pivoting line. The sewing ring may be convertible between bi-stable positions. The ring may extend outward in a frusto-conical shape so as to enable inversion between a position facing the inflow end of the valve and a position facing the outflow end of the valve. The sewing ring may have a compliant insert having a celled construction defined by outer walls and inner ribs. A method of implantation, and a method of assembly of the heart valve is also provided.

Claims

1. A heart valve having an inflow end and an outflow end, comprising:

an annular stent defining an undulating outflow edge that alternates between curvilinear cusps and upstanding commissures;

a suture-permeable sewing ring attached to a periphery of the stent by a single piece of fabric that encompasses the stent and an annular sewing ring insert formed from a suture-permeable insert material, the fabric covered insert defining the sewing ring, wherein a seam is provided in the fabric defining a line of attachment between the sewing ring and the stent, and wherein the sewing ring pivots about the seam between a first position in which the sewing ring extends toward the outflow end of the valve and a second position in which the sewing ring extends toward the inflow end of the valve, wherein the insert includes alternating radially thick and thin regions facilitating pivoting of the sewing ring between the first and second positions; and

a plurality of flexible leaflets supported by the stent.

2. The heart valve of claim 1, wherein first and second positions are stable such that the sewing ring is bi-stable.

3. The heart valve of claim 1, wherein the sewing ring includes a generally frusto-conical insert ring and wherein the first and second positions correspond to the frusto-conical insert ring extending toward the outflow end and the inflow end of the valve, respectively.

4. The heart valve of claim 1, further including an annular stiffening member co-extensive with the insert ring and encompassed by the single piece of fabric and formed of a material that is stiffer than the insert material.

5. The heart valve of claim 1, wherein the insert has a radially undulating shape facilitating pivoting of the sewing ring between the first and second positions.

6. The heart valve of claim 1, wherein the insert is substantially planar.

7. The heart valve of claim 4, wherein the stiffening member is a flat, suture-permeable ring of stiff textile positioned on top of the insert and wrapped within the single piece of fabric.

8. The heart valve of claim 7, wherein the flat, suture-permeable ring is a non-woven polyester and the insert is silicone rubber.

9. The heart valve of claim 1, wherein the fabric is rolled into a sewing tab along the undulating outflow edge of the stent, the tab being attached directly to the stent to prevent movement of the fabric upon pivoting of the insert.

10. The heart valve of claim 9, further including a fabric-covered wireform secured to the sewing tab and to which the leaflets attach.

24. The heart valve of claim 4, wherein the stiffening member is embedded within the insert.

25. The heart valve of claim 24, wherein the stiffening member is a non-woven polyester and the insert is silicone rubber.

11. A heart valve, comprising:

an annular stent having a periphery;

a sewing ring comprising an annular suture-permeable insert formed from a suture-permeable insert material and sized at least as large as the stent periphery, and an annular stiffening member co-extensive with the insert formed of a material that is stiffer than the insert material; and

a tubular fabric at least partly covering the stent, the insert and the stiffening member;

wherein the stent and insert are connected together exclusively by a portion of the fabric that permits relative outward pivoting of the sewing ring with respect to the stent.

12. The heart valve of claim 11, wherein a seam is provided in the fabric defining a line of attachment between the insert and the stent, and wherein the sewing ring pivots about the seam.

13. The heart valve of claim 11, wherein the fabric is a single piece prior to assembly of the heart valve.

14. The heart valve of claim 13, wherein the single piece of fabric completely encompasses both the stent and insert.

15. The heart valve of claim 14, wherein the fabric is rolled into a sewing tab along the undulating outflow edge, the tab being attached directly to the stent to prevent movement of the fabric upon pivoting of the sewing ring.

16. The heart valve of claim 15, further including a fabric-covered wireform secured to the sewing tab and to which the leaflets attach.

17. The heart valve of claim 11, wherein the sewing ring pivots outward with respect to the stent to first and second stable positions such that the sewing ring is bi-stable.

18. The heart valve of claim 17, wherein the sewing ring insert comprises a suture-permeable, generally frusto-conical insert ring and wherein the first and second positions correspond to the frusto-conical insert ring extending toward the outflow end and the inflow end of the valve, respectively.

19. The heart valve of claim 17, wherein the insert ring includes alternating radially thick and thin regions facilitating movement of the sewing ring between the first and second positions.

20. The heart valve of claim 17, wherein the insert ring has a radially undulating shape facilitating pivoting of the sewing ring between the first and second positions.

21. The heart valve of claim 11, wherein the stiffening member is a flat, suture-permeable ring of stiff textile positioned on top of the insert and wrapped within the single piece of fabric.

22. The heart valve of claim 11, wherein the stiffening member is embedded within the insert.

23. The heart valve of claim 22, wherein the stiffening member is a non-woven polyester and the insert is silicone rubber.