Anatomically approximate prosthetic mitral valve

• US 8,034,104 B2
• Filed: 09/23/2010
• Issued: 10/11/2011
• Est. Priority Date: 01/23/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Lam, Hung L., Carpentier, Alain
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): Ganesan; Suba
• Application Number:
  US12/889,223
• Publication Number:
  US 20110015731A1
• Time in Patent Office: 383 Days
• Field of Search: 623 212- 216, 623 238- 24, 623/2.17, 623/2.18, 623/2.19, 623/2.41
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

An anatomically approximate prosthetic heart valve includes dissimilar flexible leaflets, dissimilar commissures and/or a non-circular flow orifice. The heart valve may be implanted in the mitral position and have one larger leaflet oriented along the anterior aspect so as to mimic the natural anterior leaflet. Two other smaller leaflets extend around the posterior aspect of the valve. A basic structure providing peripheral support for the leaflets includes two taller commissures on both sides of the larger leaflet, with a third, smaller commissure between the other two leaflets. The larger leaflet may be thicker and/or stronger than the other two leaflets. The base structure defines a flow orifice intended to simulate the shape of the mitral annulus during the systolic phase. For example, the flow orifice may be elliptical. A relatively wide sewing ring has a contoured inflow end and is attached to the base structure in such a way that the valve can be implanted in an intra-atrial position and the taller commissures do not extend too far into the left ventricle, therefore avoiding injury to the ventricle.

Claims

1. A prosthetic heart valve having a low outflow profile, comprising:

a base structure having a central flow orifice oriented around a flow axis and having an outflow edge with alternating commissures and cusps, wherein the commissures define an outflow end of the valve;

a plurality of flexible leaflets mounted on the base structure and projecting into the flow orifice, the flexible leaflets being mounted in the base structure so as to define a leaflet axial dimension as measured approximately from an inflow end to the outflow end of the valve; and

a sewing ring having a scalloped inflow profile mounted around the base structure having a scalloped inflow edge and a planar outflow surface, the sewing ring defining a constant tissue attachment elevation at the planar outflow surface, wherein at the base structure commissures the distance between the attachment elevation and the valve outflow end relative to the leaflet axial dimension is less than about 75%, and wherein the sewing ring includes an inner wall and the base structure mounts within the inner wall.

2. The heart valve of claim 1, wherein the base structure further includes a stent having three arcuate cusps on an inflow end and three upstanding commissures on an outflow end.

3. The heart valve of claim 2, wherein there are three arcuate ledges provided on the inner wall of the sewing ring descending downward from the outflow surface to which the cusps of the stent attach, and wherein the sewing ring has an overall axial dimension and the three ledges provided on the inner wall arc downward from the outflow surface to a depth that is greater than about 80% of the overall axial dimension of the sewing ring.

4. The heart valve of claim 2, wherein there are three arcuate ledges provided on the inner wall of the sewing ring that descend downward from the outflow surface, and the stent is enclosed within a cloth covering defining an outwardly extending flange that projects over and is attached directly to the sewing ring only at the three ledges.

5. The heart valve of claim 1, wherein the central flow orifice is non-circular.

6. The heart valve of claim 5, wherein the non-circular central flow orifice is elliptical.

7. The heart valve of claim 5, wherein the valve is configured for placement in the mitral annulus, and the non-circular central flow orifice is substantially in the shape of a mitral annulus in its systolic phase.

8. The heart valve of claim 7, wherein the sewing ring is configured to attach to tissue of a left atrium adjacent to the mitral annulus.

9. The heart valve of claim 1, wherein at least one of the plurality of flexible leaflets is configured differently from the others.

10. The heart valve of claim 9, wherein the at least one of the plurality of flexible leaflets is larger than the others.

11. The heart valve of claim 1, wherein the base structure includes a support band having an outflow edge with alternating commissure sections and cusp sections, and wherein there are three arcuate ledges provided on the inner wall of the sewing ring that descend downward from the outflow surface, and the support band has a cloth covering rolled into outwardly extending cuffs at the outflow edge thereof that extend over and attach to the three ledges.

12. The heart valve of claim 1, wherein the base structure includes a support band having a scalloped inflow edge, and wherein the support band mounts within the sewing ring inner wall such that the scalloped inflow edge of the support band abuts and extends around the flow orifice coincident with the scalloped inflow edge of the sewing ring.

13. A prosthetic heart valve having a low outflow profile, comprising:

a base structure having a central flow orifice oriented around a flow axis partly defined by a stent having three arcuate cusps on an inflow end and three upstanding commissures on an outflow end, the stent being enclosed within a cloth covering defining an outwardly extending flange;

a plurality of flexible leaflets mounted on the stent and projecting into the flow orifice, the flexible leaflets being mounted on the stent so as to define a leaflet axial dimension as measured approximately from the inflow end to the outflow end of the stent; and

a sewing ring having a scalloped inflow profile and a planar outflow surface mounted around the base structure at an attachment elevation at the planar outflow surface of the sewing ring, wherein the sewing ring includes an inner wall defining three separated ledges descending downward from the outflow surface and intermittently provided around the inner wall, and wherein the stent cusps are located radially within the sewing ring inner wall and the flange of the cloth covering extends over the three ledges and attaches thereto.

14. The heart valve of claim 13, wherein the sewing ring has an overall axial dimension and the three ledges arc downward from the outflow surface to a depth that is greater than about 80% of the overall axial dimension of the sewing ring.

15. The heart valve of claim 13, wherein the central flow orifice is non-circular.

16. The heart valve of claim 15, wherein the non-circular central flow orifice is elliptical.

17. The heart valve of claim 15, wherein the valve is configured for placement in the mitral annulus, and the non-circular central flow orifice is substantially in the shape of a mitral annulus in its systolic phase.

18. The heart valve of claim 13, wherein at least one of the plurality of flexible leaflets is configured differently from the others.

19. The heart valve of claim 18, wherein the at least one of the plurality of flexible leaflets is larger than the others.

20. The heart valve of claim 13, wherein the base structure further includes a support band having an outflow edge with alternating commissure sections and cusp sections, and the support band has a cloth covering rolled into outwardly extending cuffs at the outflow edge thereof that extend over and attach to the three ledges as well as the stent cloth covering flange.