Anatomically approximate prosthetic mitral heart valve

• US 7,871,435 B2
• Filed: 01/19/2005
• Issued: 01/18/2011
• Est. Priority Date: 01/23/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: La France, Hugues, Lam, Hung L., Carpentier, Alain F.
• Primary Examiner(s): McDermott; Corrine M
• Assistant Examiner(s): Ganesan; Suba
• Application Number:
  US11/039,522
• Publication Number:
  US 20060293745A1
• Time in Patent Office: 2,190 Days
• Field of Search: 623/2.1, 623/2.12, 623/2.13, 623/2.14, 623/2.15, 623/2.17, 623/2.18, 623/2.38, 623/2.39, 623/2.4, 623/1.24, 623/1.26, 623/2.16, 623/2.19, 623/2.41
• US Class Current: 623/2.15
• 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 comprising:

a base structure having an elliptical central flow orifice oriented around a flow axis, wherein the base structure includes a stent having three arcuate cusps on an inflow end and three upstanding commissures on an outflow end;

a sewing ring having an outflow edge mounted around the stent such that the commissures extend in the outflow direction from the sewing ring; and

three separate flexible leaflets each having a peripheral cusp edge mounted around a cusp of the stent so as to define a free edge extending into the flow orifice,

wherein at least one of the three flexible leaflets is substantially larger than the other two, and the prosthetic heart valve is oriented for placement within the mitral annulus such that the larger leaflet is on an anterior side and the two smaller leaflets are on a posterior side, and further wherein the cusp edge of each flexible leaflet terminates in a pair of commissure edges, with the 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 leaflet attaches have greater dimensions along the flow axis than the third commissure.

2. The heart valve of claim 1, wherein the elliptical central orifice is in the shape of a mitral annulus in its systolic phase.

3. The heart valve of claim 1, wherein the stent includes a wireform having cusps and commissures, and wherein each leaflet commissure edge includes a tab that extends radially outward with respect to a wireform commissure and attaches on the outer side thereof.

4. The heart valve of claim 3, wherein the stent further includes a primary band having an outflow edge that mimics the alternating cusp and commissure shape of the wireform and is located radially outward from the wireform, wherein the leaflet tabs attach to the band outward from the wireform commissures.

5. The heart valve of claim 4, further including a secondary band surrounding the primary band and providing rigidity to an inflow edge thereof.

6. The heart valve of claim 1, wherein the flexible leaflets are bioprosthetic tissue leaflets and at least one of the three leaflets is substantially thicker than the other two leaflets.

7. The heart valve of claim 6, wherein the larger leaflet is the thicker leaflet.

8. The heart valve of claim 1, wherein an angular distance A around the base structure between first and second commissures that support the larger leaflet is greater than an angular distance P1 from the first commissure to the third commissure, and greater than an angular distance P2 from the second commissure to the third commissure.

9. The heart valve of claim 8, wherein the angular distance A is between about 34-40% of the total angular distance around the base structure.

10. A prosthetic heart valve, comprising:

three separate flexible leaflets;

a base structure on which the flexible leaflets mount having a central flow orifice oriented around a flow axis and including a stent having three cusps on an inflow end alternating with three commissures on an outflow end, the flexible leaflets each having a peripheral cusp edge mounted around a cusp of the stent so as to define a free edge extending into the flow orifice, wherein an angular distance A around the base structure between first and second commissures is greater than an angular distance P₁ from the first commissure to a third commissure, and greater than an angular distance P₂ from the second commissure to the third commissure, P₁ and P₂ being equal, and wherein the first and second commissures are of equal axial dimension and the third commissure has an axial dimension that is less than about 85% of the equal axial dimensions of the first and second commissures; and

a sewing ring having an outflow edge mounted around the stent such that the commissures extend in the outflow direction from the sewing ring.

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

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

13. The heart valve of claim 11, wherein the prosthetic heart valve is configured for placement in a mitral annulus, and the non-circular central orifice is substantially in the shape of a mitral annulus in its systolic phase.

14. The heart valve of claim 10, wherein the cusp edge of each flexible leaflet terminates in a pair of commissure edges, with the 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.

15. The heart valve of claim 14, wherein the stent includes a wireform having cusps and commissures, and wherein each leaflet commissure edge includes a tab that extends radially outward with respect to a wireform commissure and attaches on the outer side thereof.

16. The heart valve of claim 15, wherein the stent further includes a primary band having an outflow edge that mimics the alternating cusp and commissure shape of the wireform and is located radially outward from the wireform, wherein the leaflet tabs attach to the band outward from the wireform commissures.

17. The heart valve of claim 16, further including a secondary band surrounding the primary band and providing rigidity to an inflow edge thereof.

18. The heart valve of claim 10, wherein at least one of the flexible leaflets is configured differently than one of the others.

19. The heart valve of claim 18, wherein the flexible leaflet that is configured differently is substantially larger in occluding area than the other flexible leaflets.

20. The heart valve of claim 19, wherein the prosthetic heart valve is oriented for placement within the mitral annulus, and wherein the larger flexible leaflet attaches between the first and second commissures that are spaced apart around the circumference of the valve at the approximate location of fibrous trigones of the mitral annulus such that the larger flexible leaflet simulates the anterior leaflet of the mitral annulus.

21. The heart valve of claim 18, wherein the thickness of the flexible leaflet that is configured differently is between about 10-100% greater than the thickness of the other leaflets.