REPLACEMENT MITRAL VALVES

• US 20180206985A1
• Filed: 03/01/2018
• Published: 07/26/2018
• Est. Priority Date: 01/23/2017
• Status: Active Grant

• Current Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Dan Wallace, Jonathan Oakden
• Inventors: NOE, Spencer, WALLACE, Dan, OAKDEN, Jonathan
• Granted Patent: US 10,828,153 B2
• Time in Patent Office: Days
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405

Abstract

A prosthetic mitral valve includes an anchor assembly, a strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular anchor and the atrial anchor are configured to flare radially outwards relative to the central portion. The annular strut frame is disposed radially within the anchor assembly and is attached to the anchor assembly. The central portion is configured to align with a native valve orifice and the ventricular anchor and the atrial anchor are configured to compress native cardiac tissue therebetween.

Claims

1. A prosthetic mitral valve comprising:

a valve support assembly comprising a ventricular anchor and an atrial anchor, the valve support assembly having a plurality of slots therethrough;

a plurality of replacement leaflets, each leaflet having a leaflet arm extending through one of the plurality of slots;

a plurality of commis sure plates, each commissure plate circumferentially and axially aligned with one of the plurality of slots to form a commis sure attachment mechanism, wherein each commissure plate further includes a plurality of channels in the sides thereof; and

at least one suture at each commissure attachment mechanism, the at least one suture positioned around a portion of the valve support assembly, through the plurality of indents, and around the commissure plate.

2. The prosthetic mitral valve of claim 1, wherein the valve support assembly includes an anchor assembly comprising the ventricular and atrial anchors and an annular strut frame including the plurality of slots, wherein the annular strut frame is positioned radially within the anchor assembly.

3. The prosthetic mitral valve of claim 2, wherein the plurality of slots are in a portion of the strut frame that extends past the anchor assembly in the ventricular direction.

4. The prosthetic mitral valve of claim 2, wherein the anchor assembly further comprises a central portion, the ventricular and atrial anchors flared radially outwards relative to the central portion.

5. The prosthetic mitral valve of claim 1, wherein the plurality of channels extend from the sides of each commis sure plate towards a center of the plate.

6. The prosthetic mitral valve of claim 1, wherein the plurality of channels are substantially straight.

7. The prosthetic mitral valve of claim 1, wherein there are between 6 and 12 channels in each commissure plate.

8. The prosthetic mitral valve of claim 1, wherein each of the slots in an axially extending strut.

9. The prosthetic mitral valve of claim 1, wherein arms of the leaflets extend through the plurality of slots.

10. The prosthetic mitral valve of claim 9, wherein the arms are further wound around an outer perimeter of an inner strut frame of the valve support assembly.

11. The prosthetic mitral valve of claim 1, wherein the plurality of slots are positioned equidistance around a circumference of the valve support assembly.

12. The prosthetic mitral valve of claim 1, wherein each of the plurality of slots is positioned towards a ventricular end of the valve support assembly.

13. The prosthetic mitral valve of claim 1, wherein the valve support assembly is configured to self-expand from a constrained configuration to an expanded configuration.

14. The prosthetic mitral valve of claim 1, wherein atrial edges of the leaflets are sewn around an inner circumference of the valve support assembly.

15. The prosthetic mitral valve of claim 1, wherein each of the leaflets further includes a leaflet protector thereon, the leaflet protector made of a lubricious fabric and configured to protect the leaflet from an inner circumference of the valve support assembly.

27. The prosthetic mitral valve of claim 6, wherein each of the plurality of slots is positioned towards a ventricular end of the strut frame.

28. The prosthetic mitral valve of claim 1, wherein the valve support assembly is configured to self-expand from a constrained configuration to an expanded configuration.

29. The prosthetic mitral valve of claim 1, wherein atrial edges of the leaflets are sewn around an inner circumference of the strut frame.

30. The prosthetic mitral valve of claim 1, wherein each of the leaflets further includes a leaflet protector thereon, the leaflet protector made of a lubricious fabric and configured to protect the leaflet from an inner circumference of the valve support assembly.

16. A prosthetic mitral valve comprising:

a valve support assembly comprising;

an anchor assembly including a ventricular anchor and an atrial anchor; and

an annular strut frame positioned radially within the anchor assembly, the annular strut frame including a plurality of slots therethrough;

a plurality of replacement leaflets, each leaflet having a leaflet arm extending through one of the plurality of slots; and

a plurality of commis sure plates, each commissure plate circumferentially and axially aligned with one of the plurality of slots to form a commis sure attachment mechanism, wherein each commissure plate further includes a plurality of channels in the sides thereof.

17. The prosthetic mitral valve of claim 16, further comprising at least one suture at each commissure attachment mechanism, the at least one suture positioned around the annular strut frame, through the plurality of indents, and around the commis sure plate.

18. The prosthetic mitral valve of claim 16, wherein the plurality of slots are in a portion of the strut frame that extends past the anchor assembly in the ventricular direction.

19. The prosthetic mitral valve of claim 16, wherein the anchor assembly further comprises a central portion, the ventricular and atrial anchors flared radially outwards relative to the central portion.

20. The prosthetic mitral valve of claim 16, wherein the plurality of channels extend from the sides of each commis sure plate towards a center of the plate.

21. The prosthetic mitral valve of claim 16, wherein the plurality of channels are substantially straight.

22. The prosthetic mitral valve of claim 16, wherein there are between 6 and 12 channels in each commissure plate.

23. The prosthetic mitral valve of claim 16, wherein each of the slots in an axially extending strut.

24. The prosthetic mitral valve of claim 16, wherein arms of the leaflets extend through the plurality of slots.

25. The prosthetic mitral valve of claim 24, wherein the arms are further wound around an outer perimeter of the strut frame.

26. The prosthetic mitral valve of claim 16, wherein the plurality of slots are positioned equidistance around a circumference of the strut frame.