Prosthetic mitral heart valve having a contoured sewing ring

• US 7,776,084 B2
• Filed: 07/13/2005
• Issued: 08/17/2010
• 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): McDermott; Corrine M
• Assistant Examiner(s): Ganesan; Suba
• Application Number:
  US11/181,190
• Publication Number:
  US 20070016289A1
• Time in Patent Office: 1,861 Days
• Field of Search: 623/2.36, 623/2.4, 623/2.41, 623/2.16, 623/2.37, 623/2.38, 623/2.39, 623/2.17, 623/2.18, 623 212- 215
• US Class Current: 623/2.19
• 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 prosthetic mitral heart valve for implant at a mitral valve annulus, the annulus featuring two anterior trigones spaced apart approximately 120°

, comprising;

a support frame defining an orifice about an axis along an inflow-outflow direction;

a plurality of leaflets mounted for movement on the support frame to provide a one-way valve in the orifice; and

a sewing ring connected to and positioned around the support frame 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 exactly 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 upon implantation, the two axially-raised portions both extending the full radial extent of the sewing ring,

wherein the support frame has an undulating shape including three axially-oriented commissures extending toward the outflow direction alternating with three cusps extending toward the inflow direction, two of the commissures being located adjacent the two axially-raised portions of the sewing ring, and the heart valve includes three flexible leaflets mounted around the undulating shape of the support frame.

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

3. The heart valve of claim 1, wherein the suture-permeable annular member has variable compliance around its circumference.

4. The heart valve of claim 3, wherein the sewing ring is 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 the mid-way point.

5. The heart valve of claim 4, wherein the sewing ring comprises a suture-permeable annular member surrounded by a fabric covering, the annular member having a plurality of radial walls defining spaces therebetween, and wherein the radial walls at a point mid-way between the axially-raised portions, as located around the shorter distance therebetween, are thicker than the radial walls at a location diametrically opposite the mid-way point.

6. The heart valve of claim 4, wherein the sewing ring comprises a suture-permeable annular member surrounded by a fabric covering, the annular member having a plurality of walls defining spaces therebetween, and wherein the spaces at a point mid-way between the axially-raised portions, as located around the shorter distance therebetween, are smaller than the spaces at a location diametrically opposite the mid-way point.

7. The heart valve of claim 1, wherein the sewing ring comprises a rolled fabric, wherein the fabric is rolled more tightly at a point mid-way between the axially-raised portions, as located around the shorter distance therebetween, than at a location diametrically opposite the mid-way point.

8. A prosthetic mitral heart valve for implant at a mitral valve annulus, the annulus featuring two anterior trigones spaced apart approximately 120°

, comprising;

a support frame defining an orifice about an axis along an inflow-outflow direction;

a plurality of leaflets mounted for movement on the support frame to provide a one-way valve in the orifice; and

a sewing ring connected to and positioned around the support frame 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 upon implantation, and

wherein the sewing ring comprises a suture-permeable annular member surrounded by a fabric covering, the annular member having a plurality of walls defining spaces therebetween, and wherein the spaces at a point mid-way between the axially-raised portions, as located around the shorter distance therebetween, are smaller than the spaces at a location diametrically opposite the mid-way point, such that the sewing ring is less flexible at the mid-way point between the axially-raised portions than at the diametrically opposite location.

9. The heart valve of claim 8, wherein the support frame has an undulating shape including three axially-oriented commissures extending toward the outflow direction alternating with three cusps extending toward the inflow direction, two of the commissures being located adjacent the two axially-raised portions of the sewing ring, and the heart valve includes three flexible leaflets mounted around the undulating shape of the support frame.

10. The heart valve of claim 8, wherein the support frame has a generally annular configuration, and the heart valve includes two rigid leaflets mounted for pivoting movement within the support frame.

11. The heart valve of claim 8, wherein the axially-raised portions gently curve upward from the adjacent portions of the outflow end to a height of about 50% of the greatest axial dimension of the sewing ring.

12. The heart valve of claim 8, wherein the radial walls of the annular member at the mid-way point between the axially-raised portions are thicker than the radial walls at the diametrically opposite location.

13. The heart valve of claim 8, wherein the spaces between the axially-raised portions, as located around the shorter distance therebetween, are all smaller than the spaces around the rest of the annular member.

14. A prosthetic mitral heart valve for implant at a mitral valve annulus, the annulus featuring two anterior trigones spaced apart approximately 120°

, comprising;

a support frame defining an orifice about an axis along an inflow-outflow direction;

a plurality of leaflets mounted for movement on the support frame to provide a one-way valve in the orifice; and

a sewing ring connected to and positioned around the support frame 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 upon implantation, and

wherein the sewing ring comprises a suture-permeable annular member surrounded by a fabric covering, the annular member having a plurality of radial walls defining spaces therebetween, and wherein the radial walls at a point mid-way between the axially-raised portions, as located around the shorter distance therebetween, are thicker than the radial walls at a location diametrically opposite the mid-way point, such that the sewing ring is less flexible at the mid-way point between the axially-raised portions than at the diametrically opposite location.

15. The heart valve of claim 14, wherein the support frame has an undulating shape including three axially-oriented commissures extending toward the outflow direction alternating with three cusps extending toward the inflow direction, two of the commissures being located adjacent the two axially-raised portions of the sewing ring, and the heart valve includes three flexible leaflets mounted around the undulating shape of the support frame.

16. The heart valve of claim 14, wherein the support frame has a generally annular configuration, and the heart valve includes two rigid leaflets mounted for pivoting movement within the support frame.

17. The heart valve of claim 14, wherein the axially-raised portions gently curve upward from the adjacent portions of the outflow end to a height of about 50% of the greatest axial dimension of the sewing ring.