Methods of implant of a heart valve with a convertible sewing ring

• US 9,439,762 B2
• Filed: 01/23/2013
• Issued: 09/13/2016
• 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
• Primary Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US13/748,216
• Publication Number:
  US 20130184814A1
• Time in Patent Office: 1,329 Days
• Field of Search: 623/2.1, 623/2.38, 623/2.41
• US Class Current: 1/1
• 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. A method of implantation, and a method of assembly of the heart valve is also provided.

Claims

1. A method of implanting at a heart valve annulus a prosthetic heart valve having an inflow end and an outflow end that define a flow direction through the valve, a structural stent, and a sewing ring attached to a periphery thereof, comprising:

orienting the sewing ring in a second stable orientation extending generally against the flow direction and away from the stent;

attaching the sewing ring to the annulus; and

re-positioning the valve with respect to the attached sewing ring so that the sewing ring is in a first stable orientation extending generally with the flow direction and substantially adjacent the stent, and the step of re-positioning includes displacing the valve with respect to the sewing ring so that the sewing ring inverts from its second orientation extending generally against the flow direction to its first orientation extending generally with the flow direction.

2. The method of claim 1, wherein the step of attaching comprises suturing the sewing ring to the annulus by first passing sutures through the annulus, extending the sutures out of the surgical field, and passing the sutures through the sewing ring while it is oriented to extend generally against the flow direction.

3. The method of claim 1, wherein the sewing ring comprises a suture-permeable insert ring and a fabric cover, and the fabric cover surrounds the insert ring and connects the insert ring to the stent periphery at a single seam, the seam defining a generally circular line about which the sewing ring pivots.

4. The method of claim 3, wherein the single seam enables the sewing ring to be bi-stable between the orientations of extending generally with and against the flow direction.

5. The method of claim 3, wherein the single seam is located at an inflow end of the structural stent and the annulus is the aortic annulus, wherein the method includes implanting the prosthetic heart valve in a supra-annular position within the annulus.

6. The method of claim 1, wherein the heart valve has a plurality of leaflets supported by the structural stent.

7. The method of claim 1, wherein the sewing ring comprises a suture-permeable insert and a fabric cover, and wherein the insert includes a generally frusto-conical band extending outwardly from the stent, and wherein the inverted orientations correspond to the frusto-conical band extending generally with and against the flow direction, respectively.

8. The method of claim 7, wherein the insert has alternating radially thick and thin regions facilitating inversion of the sewing ring between the two orientations.

9. The method of claim 7, wherein the insert has a radially undulating shape facilitating inversion of the sewing ring between the two orientations.

10. The method of claim 7, wherein the sewing ring further includes a stiffening member around its periphery stiffer than the insert that helps maintain the sewing ring in each of its two orientations.

11. A method of implanting at a heart valve annulus a prosthetic heart valve having an inflow end and an outflow end that define a flow direction through the valve, a structural stent defining a periphery, and a sewing ring attached to the stent periphery and having two bi-stable orientations, comprising:

positioning the sewing ring in a first of its bi-stable orientations so as to position the sewing ring substantially adjacent the stent periphery;

re-positioning the sewing ring into a second of its bi-stable orientations so as to extend generally outward from the first position and farther away from the stent; and

attaching the sewing ring to the annulus.

12. The method of claim 11, wherein the sewing ring is attached to the stent periphery along a generally circular line, and wherein the sewing ring pivots between the first and second bi-stable orientations about the line.

13. The method of claim 12, wherein the sewing ring comprises a suture-permeable insert ring and a fabric cover, and wherein the fabric cover surrounds the insert ring and connects the insert ring to the stent periphery at a single seam, the seam defining the line about which the sewing ring pivots between its bi-stable orientations.

14. The method of claim 13, wherein the single seam is located at an inflow end of the structural stent and the annulus is the aortic annulus, wherein the method includes implanting the prosthetic heart valve in a supra-annular position within the annulus.

15. The method of claim 11, wherein the sewing ring comprises a suture-permeable insert and a fabric cover, and wherein the insert includes a generally frusto-conical band extending outwardly from the stent, and wherein the bi-stable orientations correspond to the frusto-conical band extending generally with and against the flow direction, respectively.

16. The method of claim 15, wherein the insert has alternating radially thick and thin regions facilitating inversion of the sewing ring between the two orientations.

17. The method of claim 15, wherein the insert has a radially undulating shape facilitating inversion of the sewing ring between the two orientations.

18. The method of claim 15, wherein the sewing ring further includes a stiffening member around its periphery stiffer than the insert that helps maintain the sewing ring in each of its two orientations.

19. The method of claim 11, wherein the step of attaching comprises suturing the sewing ring to the annulus by first passing sutures through the annulus, extending the sutures out of the surgical field, and passing the sutures through the sewing ring while it is in its second bi-stable orientation.

20. The method of claim 19, wherein the first and second bi-stable orientations correspond to the sewing ring extending generally with and against the flow direction, respectively, and the step of passing the sutures through the sewing ring occurs outside the body with the sewing ring in its second bi-stable orientation extending generally against the flow direction, and wherein the annulus is the aortic annulus and the method includes guiding the heart valve along the sutures until just before the sewing ring seats in contact with the aortic annulus, moving the sewing ring back from its second bi-stable orientation against the flow direction to its first bi-stable orientation extending generally with the flow direction, seating the sewing ring in contact with the annulus, and tying the sutures off.