Sewing ring having increased annular coaptation

• US 6,045,576 A
• Filed: 09/16/1997
• Issued: 04/04/2000
• Est. Priority Date: 09/16/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Starr, Albert, Helmus, Michael N., Stobie, Robert
• Primary Examiner(s): Snow, Bruce E.
• Application Number:
  US08/932,818
• Time in Patent Office: 931 Days
• Field of Search: 623/1, 623/2, 623/900, 606/151, 606/153
• US Class Current: 623/2.41
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442

Abstract

A sewing ring for implantation of prosthetic heart valves has a compliant ring member made of a plurality of cells. The ring member may be silicon rubber and the cells defined within outer walls and inner ribs. A biocompatible fabric covering surrounds at least an outer portion of the ring member, and the assembly mounts to a mechanical or tissue-type prosthetic heart valve. The ring member has a radial dimension and cross-sectional area sufficient to ensure a large coaptation area between the sewing ring and the annulus tissue so as to enable adequate attachment of the valve without load distributing devices such as pledgets. A version of the sewing ring for attachment to the mitral annulus includes a curved coaptation edge, while another embodiment for attachment to the aortic annulus has a tapered outer edge with increased radial and axial dimensions. The sewing ring eliminates the need for pledgets, reduces the number of sutures required, lessens the potential for decubitous ulceration, and provides a better seal against perivalvular leakage. Moreover, the aortic valve sewing ring is sufficiently flexible and large to be able to be placed intra- or supra-annularly, as the surgeon deems best for the patient.

Claims

1. A sewing ring for use in implanting a prosthetic heart valve to a support annulus, comprising:

a suture-penetable annular ring member formed of a plurality of deformable walls, some of which are radially aligned to define open cells therebetween, the annular ring member being oriented about an axis and having a top end and a bottom end spaced along the axis, the annular ring member having a cross section defined by an axially extending inner ring side, a top side projecting radially outward from the top end of the inner ring side, and a coaptation side extending between an outermost projection of the top side and the inner ring side, wherein the coaptation side is at least partly concavely curved and is defined by one of the deformable walls to thereby provide a concavely curved tissue coaptation surface around the periphery of the ring that compliantly conforms to the support annulus and resists perivalvular leaking therebetween; and

a fabric covering surrounding at least an outer portion of the annular ring member.

2. The sewing ring of claim 1, wherein the coaptation side is defined as a curve of a constant radius.

3. The sewing ring of claim 2, wherein the constant radius is approximately 4.45 mm.

4. The sewing ring of claim 1, wherein the coaptation side is formed as a complex curve with more than one radius of curvature.

5. The sewing ring of claim 1, wherein the coaptation side is formed as an aspheric curve with a constantly changing radius of curvature.

6. The sewing ring of claim 1, wherein the top side projects directly radially outwardly from top end of the inner ring side a distance of at least about 3.18 mm.

7. The sewing ring of claim 6, wherein the top side projects radially outwardly a distance of about 4.32 mm.

8. The sewing ring of claim 6, wherein the coaptation side is defined as a curve of a constant radius at least as great as the distance the top side projects radially outwardly.

9. The sewing ring of claim 1, wherein the fabric covering is treated with a chemical to improve biocompatibility.

10. The sewing ring of claim 9, wherein the chemical comprises heparin.

11. The sewing ring of claim 1, wherein the annular ring member comprises silicone rubber.

12. A heart valve, comprising:

the sewing ring of claim 1;

a rigid annular valve body; and

an annular stent intermediate the valve body and sewing ring.

13. The valve of claim 12, wherein the fabric covering surrounds both the annular ring member and at least a portion of the annular stent, and extends partway between the stent and valve body.

14. The valve of claim 13, wherein the fabric covering is in two pieces, a first piece around the inflow end of the stent and annular ring member and a second piece around the outflow end of the stent.

15. The valve of claim 14, wherein a portion of the second piece extends between the stent and annular ring member.

16. The valve of claim 14, wherein the first piece is longer than the second piece.

17. The valve of claim 12, further including a spacer sleeve positioned between the annular stent and annular ring member.

18. The valve of claim 17, wherein a first portion of the fabric covering completely surrounds the annular ring member, and a second portion surrounds the annular stent and spacer sleeve, the second portion extending between the stent and valve body and between the spacer sleeve and annular ring member.

19. The valve of claim 18, wherein the second portion is in two pieces, a first piece around the inflow end of the stent and spacer sleeve and a second piece around the outflow end of the stent and spacer sleeve.

20. The valve of claim 19, wherein the two pieces of the second portion overlap between the spacer sleeve and annular ring member.

21. The valve of claim 20, wherein the first piece is shorter than the second piece.