Low-profile heart valve sewing ring and method of use

• US 20040176839A1
• Filed: 03/17/2004
• Published: 09/09/2004
• Est. Priority Date: 06/01/2000
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Huynh, Van Le, Scott, Michael J., Johnson, Derrick
• Granted Patent: US 8,366,769 B2
• Time in Patent Office: Days
• US Class Current: 623/2.4
• 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 sewing ring attached to a generally annular periphery of a prosthetic heart valve having an inflow end and an outflow end, comprising:

a suture-permeable ring attached to the heart valve periphery and configured to pivot from a first position extending generally toward the outflow end of the valve to a second position extending generally toward the inflow end of the valve, wherein first and second positions are stable such that the sewing ring is bi-stable.

2. The sewing ring of claim 1, wherein the sewing ring comprises a suture-permeable insert ring and a fabric cover.

3. The sewing ring of claim 2, wherein the insert ring is substantially planar.

4. The sewing ring of claim 2, wherein the fabric covering the insert ring also covers a portion of the heart valve.

5. The sewing ring of claim 4, wherein the fabric covering both the insert ring and the portion of the heart valve also connects the ring to the heart valve periphery at a seam, and wherein the sewing ring pivots between the first and second positions about the seam.

6. The sewing ring of claim 1, wherein the suture-permeable ring is attached to the heart valve periphery along a line, and wherein the sewing ring pivots between the first and second positions about the line.

7. The sewing ring of claim 6, wherein the sewing ring comprises a suture-permeable insert ring and a fabric cover, and wherein the fabric covers the insert ring and connects the insert ring to the heart valve periphery at a seam, the seam defining the line about which the sewing ring pivots.

8. The sewing ring of claim 1, wherein the sewing ring includes a suture-permeable, generally frusto-conical insert ring and wherein the first and second positions correspond to the frusto-conical insert ring extending outward from the periphery in opposite axial directions.

9. The sewing ring of claim 8, wherein the insert ring includes alternating radially thick and thin regions facilitating pivoting of the sewing ring between the first and second positions.

10. The sewing ring of claim 8, wherein the insert ring has a radially undulating shape facilitating pivoting of the sewing ring between the first and second positions.

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

a generally annular stent, and

a suture-permeable sewing ring attached to a periphery of the stent so as to be moveable between two positions, wherein in the first position the sewing ring extends generally toward the outflow end of the valve and in the second position the sewing ring extends generally toward the inflow end of the valve, wherein first and second positions are stable such that the sewing ring is bi-stable.

12. The heart valve of claim 11, wherein the sewing ring comprises a suture-permeable insert ring and a fabric cover.

13. The heart valve of claim 12, wherein the fabric covering the insert ring also covers a portion of the stent.

14. The heart valve of claim 13, wherein a single piece of fabric is used to completely cover both the insert ring and the stent.

15. The heart valve of claim 11, wherein the sewing ring attaches to the stent exclusively with a portion of fabric that also covers at least a portion of the sewing ring.

16. The heart valve of claim 15, 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 the first and second positions.

17. The heart valve of claim 11, wherein the suture-permeable sewing ring is attached to the stent periphery along a line, and wherein the sewing ring pivots between the first and second positions about the line.

18. The heart valve of claim 17, wherein the sewing ring comprises a suture-permeable insert ring and a fabric cover, and wherein the fabric covers the insert ring and connects the insert ring to the stent periphery at a seam, the seam defining the line about which the sewing ring pivots.

19. The heart valve of claim 11, wherein the sewing ring includes 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.

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

21. The heart valve of claim 19, wherein the insert ring has a radially undulating shape facilitating pivoting of the sewing ring between the first and second positions.