Prosthetic heart valve with dissimilar leaflets

• US 8,721,716 B2
• Filed: 09/09/2011
• Issued: 05/13/2014
• Est. Priority Date: 01/23/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Carpentier, Alain F., Lam, Hung L., Lafrance, Hugues
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US13/229,346
• Publication Number:
  US 20120123530A1
• Time in Patent Office: 977 Days
• Field of Search: 623/2.1, 623/2.12, 623/2.13, 623/2.14, 623/2.15, 623/2.16, 623/2.17, 623/2.18, 623/2.19, 623/2.38, 623/2.39, 623/2.42, 623/1.24, 623/1.26
• US Class Current: 623/2.13
• 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.

Claims

1. A prosthetic heart valve, comprising:

a base structure having a central flow orifice oriented around a flow axis; and

three separate flexible bioprosthetic tissue leaflets mounted on the base structure and projecting into the flow orifice, wherein each flexible leaflet has a generally constant thickness across its area and the thickness of at least one of the three flexible leaflets is substantially greater than the other two leaflets.

2. The heart valve of claim 1, wherein the thicker leaflet is 10-100% thicker than the other two leaflets.

3. The heart valve of claim 1, wherein the thicker leaflet is a larger leaflet that is substantially larger in occluding area than the other two.

4. The heart valve of claim 3, wherein the prosthetic heart valve is oriented for placement within the mitral annulus such that the larger leaflet is adjacent an anterior aspect thereof and the two smaller leaflets are adjacent a posterior aspect thereof.

5. The heart valve of claim 3, wherein the base structure includes a stent having three cusps on an inflow end and three commissures on an outflow end, the three flexible leaflets each including a cusp edge terminating in a pair of commissure edges, with a free edge extending between the commissure edges and opposite the cusp edge, and wherein each leaflet attaches along its cusp and commissure edges to a cusp and two associated commissures of the stent, and wherein at least one of the commissures has a different axial dimension than at least one other commissure.

6. The heart valve of claim 5, wherein the two commissures of the stent to which the larger leaflet attaches have greater dimensions along the flow axis than the third commissure.

7. The heart valve of claim 3, wherein the angular distance around the central flow orifice of the larger leaflet is between about 34-40% of the total angular distance around the central flow orifice.

8. The heart valve of claim 1, wherein the central flow orifice is elliptical having a major axis and a minor axis.

9. The heart valve of claim 1, wherein the central flow orifice is in the shape of a mitral annulus in its systolic phase, with a longer dimension and a shorter dimension in plan view.

10. A prosthetic mitral heart valve for implant at the mitral annulus having an anterior aspect opposite a posterior aspect, comprising:

a base structure having a non-circular central flow orifice oriented around a flow axis; and

three separate flexible bioprosthetic tissue leaflets mounted on the base structure and projecting into the flow orifice, wherein at least one of the three flexible leaflets is substantially larger in occluding area than the other two, and the mitral heart valve is adapted for placement within the mitral annulus such that the larger leaflet is adjacent the anterior aspect and the two smaller leaflets are adjacent the posterior aspect, wherein each flexible leaflet has a generally constant thickness across its area and the thickness of the larger of the three flexible leaflets is substantially greater than the other two leaflets.

11. The heart valve of claim 10, wherein the non-circular central flow orifice is elliptical.

12. The heart valve of claim 10, wherein the prosthetic heart valve is configured for placement in a mitral annulus, and the non-circular central flow orifice is in the shape of a mitral annulus in its systolic phase.

13. The heart valve of claim 10, wherein the base structure includes a stent having three cusps on an inflow end and three commissures on an outflow end, the three flexible leaflets each including a cusp edge terminating in a pair of commissure edges, with a free edge extending between the commissure edges and opposite the cusp edge, and wherein each leaflet attaches along its cusp and commissure edges to a cusp and two associated commissures of the stent, and wherein the two commissures of the stent to which the larger and thicker leaflet attaches have greater dimensions along the flow axis than the third commissure.

14. The heart valve of claim 10, wherein the thicker leaflet is 10-100% thicker than the other two leaflets.

15. The heart valve of claim 10, wherein the angular distance around the central flow orifice of the larger leaflet is between about 34-40% of the total angular distance around the central flow orifice.

16. A prosthetic heart valve, comprising:

a base structure having a central flow orifice oriented around a flow axis; and

three separate flexible bioprosthetic tissue leaflets mounted on the base structure and projecting into the flow orifice, wherein at least one of the three flexible leaflets is substantially stronger than the other two leaflets as determined by its response to a force deflection test.

17. The heart valve of claim 16, wherein the stronger leaflet is also substantially larger in occluding area than the other flexible leaflets.

18. The heart valve of claim 17, wherein the angular distance around the central flow orifice of the larger leaflet is between about 34-40% of the total angular distance around the central flow orifice.

19. The heart valve of claim 16, wherein each flexible leaflet has a generally constant thickness across its area and the thickness of the stronger leaflet is also substantially greater than the other two leaflets.

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

21. The heart valve of claim 16, wherein the prosthetic heart valve is oriented for placement within the mitral annulus such that the stronger leaflet is adjacent an anterior aspect thereof and the two other leaflets are adjacent a posterior aspect thereof.

22. The heart valve of claim 16, wherein the base structure includes a stent having three cusps on an inflow end and three commissures on an outflow end, the three flexible leaflets each including a cusp edge terminating in a pair of commissure edges, with a free edge extending between the commissure edges and opposite the cusp edge, and wherein each leaflet attaches along its cusp and commissure edges to a cusp and two associated commissures of the stent, and wherein the two commissures of the stent to which the stronger leaflet attaches have greater dimensions along the flow axis than the third commissure.