Prosthetic mitral valve

• US 10,342,661 B2
• Filed: 10/01/2018
• Issued: 07/09/2019
• 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): Ganesan, Suba
• Application Number:
  US16/148,883
• Publication Number:
  US 20190029828A1
• Time in Patent Office: 281 Days
• 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

A prosthetic mitral valve with a compressible and expandable base structure that, when expanded, is circumferentially oval, elliptical, or D-shaped, with a major axis and a minor axis ratio of from about 3:4 to about 4:5. Embodiments of the base structure comprise a primary member and a secondary member surrounding the primary member and coupled thereto. Three flexible leaflets are attached to commissure sections of the primary member in a tri-foil configuration. Embodiments of the prosthetic mitral valve include an atrial ring disposed at the inflow end of the stent.

Claims

1. A prosthetic mitral valve comprising:

an inflow end, an outflow end, and a central flow axis extending from the inflow end to the outflow end;

a cloth-covered ring disposed at the inflow end of the prosthetic mitral valve, the ring comprising a plurality of cells, the ring configured for positioning on an atrial side of the native mitral valve annulus and for holding the prosthetic mitral valve in place;

a compressible and expandable base extending from the ring towards the outflow end of the prosthetic mitral valve, the base structure when expanded, being circumferentially D-shaped with a major axis longer than a minor axis thereof, the base structure dimensioned for placement within the native mitral valve annulus, the base structure having a larger diameter towards the inflow end of the prosthetic mitral valve and a smaller diameter towards the outflow end of the prosthetic mitral valve, the base structure comprising a primary member and a secondary member surrounding the primary member and coupled thereto, the primary member having a closed shape comprising an inflow edge, an outflow edge, and three commissure sections alternating three cusp sections, the secondary member having a closed shape with an inflow edge and an outflow edge;

a cloth cover disposed over the base structure; and

three flexible tissue leaflets in a tri-foil configuration, the leaflets projecting towards the flow axis, the leaflets secured to the stent along the cusp and commissure sections of the primary member.

2. The prosthetic mitral valve of claim 1, wherein the cloth covering the ring is polyethylene terephthalate.

3. The prosthetic mitral valve of claim 1, wherein the inflow edge of the ring is scalloped.

4. The prosthetic mitral valve of claim 1, wherein the cloth disposed over the base structure is polyethylene terephthalate.

5. The prosthetic mitral valve of claim 1, wherein the tissue leaflets are bovine pericardium.

6. A prosthetic mitral valve comprising:

an inflow end, an outflow end, and a central flow axis extending from the inflow end to the outflow end;

a ring disposed at the inflow end of the prosthetic mitral valve, the ring configured for positioning on an atrial side of a native mitral valve annulus and for holding the prosthetic mitral valve in place;

a compressible and expandable base structure extending from the ring towards the outflow end of the prosthetic mitral valve, the base structure when expanded, being circumferentially oval, elliptical, or D-shaped with a major axis longer than a minor axis thereof, the base structure dimensioned for placement within the native mitral valve annulus, the base structure having a larger diameter towards the inflow end of the prosthetic mitral valve and a smaller diameter towards the outflow end of the prosthetic mitral valve, the base structure comprising a primary member and a secondary member surrounding the primary member and coupled thereto, the primary member having a closed shape comprising an inflow edge, an outflow edge, and three commissure sections alternating three cusp sections, the secondary member having a closed shape with an inflow edge and an outflow edge; and

three flexible leaflets in a tri-foil configuration, the leaflets projecting towards the flow axis, the leaflets secured to the primary member along the cusp and commissure sections thereof.

7. The prosthetic mitral valve of claim 6, wherein the ring further comprises a cover comprising cloth, biocompatible fabric, or polyester terephthalate.

8. The prosthetic mitral valve of claim 6, wherein the ring comprises a plurality of cells.

9. The prosthetic mitral valve of claim 6, wherein an inflow edge of the ring is contoured to match a contour of a left atrium adjacent to the native mitral annulus.

10. The prosthetic mitral valve of claim 9, wherein the inflow edge of the ring is scalloped.

11. The prosthetic mitral valve of claim 6, wherein the base structure is circumferentially D-shaped.

12. The prosthetic mitral valve of claim 6, wherein a ratio of the minor axis to the major axis of the stent is from about 3:

4 to about 4;

5.

13. The prosthetic mitral valve of claim 6, wherein the commissure sections comprise first and second commissure sections disposed substantially symmetrically about the minor axis, and a third commissure section disposed substantially on the minor axis.

14. The prosthetic mitral valve of claim 6, further comprising a cover disposed over the base structure.

15. The prosthetic mitral valve of claim 14, wherein the cover comprises at least one of cloth, biocompatible fabric, and polyester terephthalate.

16. The prosthetic mitral valve of claim 6, wherein the primary member is a polymer and the secondary member is a metallic alloy.

17. The prosthetic mitral valve of claim 6, wherein the tissue leaflets are bovine pericardium.