Methods of implanting a prosthetic mitral heart valve having a contoured sewing ring

• US 20070016291A1
• Filed: 07/13/2005
• Published: 01/18/2007
• Est. Priority Date: 07/13/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Johnson, Derrick
• Granted Patent: US 7,682,391 B2
• Time in Patent Office: Days
• US Class Current: 623/2.410
• 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 method of implanting a prosthetic mitral heart valve at a mitral valve annulus, the annulus featuring two spaced apart anterior trigones, comprising:

providing a prosthetic mitral heart valve having an outwardly-directed sewing ring for attaching the heart valve to the mitral valve annulus, the sewing ring having an inflow end and an outflow end, wherein the outflow end includes two axially-raised portions relative to the remainder of the outflow end that are spaced apart so as to register with the two anterior trigones; and

implanting the prosthetic mitral heart valve in the mitral valve annulus such that the two axially-raised portions are located adjacent the two anterior trigones of the annulus.

2. The method of claim 1, wherein the sewing ring comprises a suture-permeable annular member, and the step of implanting comprises suturing the sewing ring to the mitral valve annulus.

3. The method of claim 1, wherein the sewing ring comprises a suture-permeable annular member surrounded by a fabric covering.

4. The method of claim 1, wherein the prosthetic mitral heart valve includes three axially-oriented commissures extending toward the outflow direction and into the ventricle when the valve is implanted, the first two commissures being located around the heart valve at the same locations as the two axially-raised portions and a third commissure being located equidistant from the first two, and the method includes tilting the prosthetic mitral heart valve at an angle with respect to an annular plane such that the third commissure angles away from the adjacent ventricular wall and reduces the chance of contact therebetween.

5. The method of claim 1, wherein the sewing ring is less flexible at the axially-raised portions than at locations diametrically opposite from the axially-raised portions.

6. The method of claim 1, wherein the mitral annulus features a portion that is more calcified than the remainder of the annulus, the method further comprising:

providing the prosthetic mitral heart valve wherein the annular member has variable compliance around its circumference; and

implanting the prosthetic mitral heart valve in the mitral valve annulus such that a relatively more compliant portion of the annular member is located adjacent the portion of the mitral annulus that is more calcified.

7. A method of implanting a prosthetic heart valve at a patient'"'"'s heart valve annulus, comprising:

providing a prosthetic heart valve having an outwardly-directed sewing ring for attaching the heart valve to the valve annulus, the sewing ring having a suture-permeable annular member arranged about an axis defining an inflow-outflow direction, the annular member having variable compliance around its circumference; and

implanting the prosthetic heart valve in the annulus such that a portion of the annular member that is relatively more compliant than a diametrically opposite portion is located at a predetermined location around the annulus.

8. The method of claim 7, wherein the annulus features an aspect that is more calcified than the remainder of the annulus, and wherein the step of implanting comprises locating the portion of the annular member that is relatively more compliant adjacent the aspect of the annulus that is more calcified.

9. The method of claim 7, wherein the heart valve annulus comprises a mitral annulus having an anterior aspect and a posterior aspect, and wherein the annular member has an anterior side for attaching to the anterior aspect of the mitral annulus and a posterior side for attaching to the posterior side of the mitral annulus, and wherein the relatively more compliant portion of the annular member is located on the posterior side thereof.

10. The method of claim 9, wherein the annular member has an inflow end and an outflow end, wherein the outflow end includes two axially-raised portions relative to the remainder of the outflow end that are spaced apart so as to register with two anterior trigones of the mitral annulus.

11. The method of claim 7, wherein the sewing ring comprises the annular member surrounded by a fabric covering.

12. The method of claim 11, wherein the annular member comprises a molded polymer having a plurality of radial walls defining spaces therebetween, and wherein the radial walls in the relatively more compliant portion are thinner than the radial walls in the diametrically opposite portion.

13. The method of claim 11, wherein the annular member comprises a molded polymer having a plurality of radial walls defining spaces therebetween, and wherein the spaces in the relatively more compliant portion are larger than the spaces in the diametrically opposite portion.

14. The method of claim 7, wherein the annular member comprises a rolled fabric, and wherein the fabric is rolled more loosely in the relatively more compliant portion than in the diametrically opposite portion.

15. The method of claim 7, wherein the annular member comprises a polymer fabric.

16. The method of claim 15, wherein the annular member comprises a rolled fabric, and wherein the fabric is rolled more loosely in the relatively more compliant portion than in the diametrically opposite portion.