Contoured sewing ring for a prosthetic mitral heart valve

• US 8,506,625 B2
• Filed: 08/09/2010
• Issued: 08/13/2013
• Est. Priority Date: 07/13/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Johnson, Derrick
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US12/852,773
• Publication Number:
  US 20110054598A1
• Time in Patent Office: 1,100 Days
• Field of Search: 623/2.1, 623 212- 219, 623 236- 241
• US Class Current: 623/2.41
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity

Abstract

A prosthetic mitral heart valve including a contoured sewing ring that better matches the mitral valve annulus. The sewing ring includes an inflow end and an outflow end, the outflow and having at least one raised portion. There may be two raised portions located approximately 120° apart from each other and designed to register with two anterior trigones of the mitral valve annulus. The sewing ring may be formed by a suture-permeable annular member surrounded by a fabric covering, the annular member desirably being molded of silicone. The raised portion(s) may gently curve upward to a height of about 2 mm above the adjacent portions of the outflow end of the sewing ring. The sewing ring may also be constructed so as to be more flexible around a posterior aspect than around an anterior aspect to accommodate calcified tissue more commonly found around the posterior annulus. The contoured sewing ring can be combined with various types of heart valve including bioprosthetic and mechanical valves. A bioprosthetic heart valve of the present invention may include a support stent having three outflow commissures alternating with three inflow cusps, with two of the commissures being located at the same place as two raised portions of the sewing ring. A method of implant includes tilting the prosthetic heart valve in the mitral annulus so that a posterior commissure angles away from the ventricular wall and reduces the chance of contact therebetween.

Claims

1. A sewing ring for a prosthetic heart valve comprising:

a suture-permeable annular member arranged about an axis defining inflow-outflow directions, the annular member having a substantially planar inflow end and having an outflow end that includes exactly two spaced apart portions that are spaced approximately 120°

apart a shorter distance around the annular member and raised axially with respect to adjacent portions of the outflow end, and wherein the outflow end is substantially planar around the longer distance between the exactly two axially-raised portions, wherein at a point mid-way between the axially-raised portions, as located around the shorter distance therebetween, the cross-sectional construction of the annular member renders it less flexible than the cross-sectional construction at a location diametrically opposite that point; and

a fabric covering surrounding the annular member.

2. The sewing ring of claim 1, wherein the axially-raised portions each gently curve upward from the adjacent portions of the outflow end to a height of about 50% of the greatest axial dimension of the annular member.

3. The sewing ring of claim 2, wherein the greatest axial dimension of the annular member is about 4 mm.

4. The sewing ring of claim 1, wherein the annular member comprises continuous circumferential inner and outer walls with a plurality of the radial walls extending therebetween.

5. The sewing ring of claim 4, wherein the axially-raised portions are each formed by an outer partial tubular wall segment that projects upward from the outer wall coinciding with an opposite inner partial tubular wall segment that projects upward from the inner wall, and the axial heights of the radial walls therebetween conform to the axial heights of the partial tubular wall segments.

6. The sewing ring of claim 5, wherein the outer wall is substantially conical and meets the inner wall on the inflow end of the annular member, the combination of the inner and outer walls together defining a solid wall that faces in the inflow direction.

7. The sewing ring of claim 1, further including location markers provided on the fabric covering on the exterior of the sewing ring denoting apices of the axially-raised portions.

8. The sewing ring of claim 1, wherein the annular member is formed from rolled fabric, and the fabric is rolled more tightly at the point mid-way between the axially-raised portions than at the location diametrically opposite that point.

9. The sewing ring of claim 1, wherein the annular member is formed with a non-woven polyester felt stuffing, and the polyester felt is packed more tightly at the point mid-way between the axially-raised portions than at the location diametrically opposite that point.

10. A sewing ring for a prosthetic heart valve comprising:

a suture-permeable annular member arranged about an axis defining inflow-outflow directions, wherein the annular member comprises molded silicone defining a plurality of circumferential and radial walls with open cells therebetween, the annular member having a substantially planar and closed inflow end, and wherein the cells open to an outflow end that is substantially planar except for two spaced apart portions raised axially with respect to the adjacent planar portions of the outflow end, wherein the annular member comprises continuous circumferential inner and outer walls with a plurality of the radial walls extending therebetween, and wherein the axially-raised portions are each formed by an outer partial tubular wall segment that projects upward from the outer wall coinciding with an opposite inner partial tubular wall segment that projects upward from the inner wall, and the axial heights of the radial walls therebetween conform to the axial heights of the partial tubular wall segments; and

a fabric covering surrounding the annular member and covering the cells on the outflow end.

11. The sewing ring of claim 10, wherein the axially-raised portions each gently curve upward from the adjacent portions of the outflow end to a height of about 50% of the greatest axial dimension of the annular member.

12. The sewing ring of claim 11, wherein the greatest axial dimension of the annular member is about 4 mm.

13. The sewing ring of claim 10, wherein there are only two axially-raised portions that are distributed asymmetrically around the circumference of the annular member.

14. The sewing ring of claim 13, wherein the two axially-raised portions are spaced approximately 120°

apart a shorter distance around the annular member.

15. The sewing ring of claim 10, wherein the axially-raised portions are equal in axial height and identical in shape.

16. The sewing ring of claim 10, wherein the inner and outer walls are thicker than the radial walls.

17. The sewing ring of claim 10, wherein the outer wall is substantially conical and meets the inner wall on the inflow end of the annular member, the combination of the inner and outer walls together defining a solid wall that faces in the inflow direction.

18. The sewing ring of claim 10, wherein the annular member is locally less flexible at a point mid-way between the axially-raised portions, as located around the shorter distance therebetween, than at a location diametrically opposite that point.

19. The sewing ring of claim 10, further including location markers provided on the fabric covering on the exterior of the sewing ring denoting apices of the axially-raised portions.

20. A sewing ring for a prosthetic heart valve comprising:

a suture-permeable annular member arranged about an axis defining inflow-outflow directions, wherein the annular member comprises molded silicone defining a plurality of circumferential and radial walls with open cells therebetween, wherein the cells around one side are smaller than the cells around another side thus rendering the annular member less compliant where the cells are smaller such that the annular member has variable compliance around its circumference; and

a fabric covering surrounding the annular member and covering the cells on the outflow end.

21. The sewing ring of claim 20, wherein the radial walls around the less compliant side are thicker than the radial walls around another side.

22. The sewing ring of claim 20, wherein the annular member has an outflow end and two spaced apart portions that are raised axially with respect to adjacent portions of the outflow end, and the cells between the axially-raised portions, as located around the shorter distance therebetween, are all smaller than the cells around the rest of the annular member.

23. The sewing ring of claim 22, wherein the two axially-raised portions on the outflow end are spaced approximately 120°

apart.

24. The sewing ring of claim 22, wherein the axially-raised portions are each formed by an outer partial tubular wall segment that projects upward from an outer circumferential wall coinciding with an opposite inner partial tubular wall segment that projects upward from an inner circumferential wall, and the axial heights of the radial walls therebetween conform to the axial heights of the partial tubular wall segments.

25. The sewing ring of claim 20, wherein the annular member has an outflow end and two spaced apart portions that are raised axially with respect to adjacent portions of the outflow end, and further including location markers provided on the fabric covering on the exterior of the sewing ring denoting apices of the axially-raised portions.

26. The sewing ring of claim 20, wherein the annular member comprises continuous circumferential inner and outer walls with a plurality of the radial walls extending therebetween, the annular member having a closed inflow end and the cells are open to the outflow side thereof.

27. The sewing ring of claim 26, wherein the outer wall is substantially conical and meets the inner wall on the inflow end of the annular member, the combination of the inner and outer walls together defining a solid wall that faces in the inflow direction.