Replacement mitral valves

Patent metadata

Field	Value
Publication number	US-10828153-B2
Application number	US-201815909881-A
Country	US
Kind code	B2
Filing date	Mar 1, 2018
Priority date	Jan 23, 2017
Publication date	Nov 10, 2020
Grant date	Nov 10, 2020

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.

First claim

The invention claimed is:

1. A prosthetic mitral valve comprising:
a valve support assembly having a constrained configuration and an expanded configuration and comprising:
an anchor assembly including a ventricular anchor, an atrial anchor and a central portion therebetween, the ventricular and atrial anchors including struts that flare radially outwards relative to the central portion in the expanded configuration, at least some of the struts of the ventricular anchor further including hooks that extend radially outward in the expanded configuration; and
a strut frame positioned radially within the anchor assembly and attached thereto such that the strut frame extends farther distally than the ventricular anchor of the anchor assembly in the expanded configuration and the strut frame 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 commissure plates attached to the strut frame, 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 extending from sides thereof; and
at least one suture at each commis sure attachment mechanism, the at least one suture positioned around a portion of the valve support assembly, through the plurality of channels, and around the commissure plate.

2. The prosthetic mitral valve of claim 1 , wherein the plurality of slots are in a portion of the strut frame that extends past the anchor assembly in the ventricular direction.

3. 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.

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

5. The prosthetic mitral valve of claim 4 , wherein each of the plurality of slots is positioned towards a ventricular end of the strut frame.

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

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

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

9. The prosthetic mitral valve of claim 8 , wherein the arms are further wound around an outer perimeter of an inner strut frame of the valve support assembly.

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

11. 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.

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

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

14. 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.

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

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

17. 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.

18. The prosthetic mitral valve of claim 1 , wherein at least a portion of the leaflet arm is positioned radially between the anchor assembly and the strut frame.

19. A prosthetic mitral valve comprising:
a valve support assembly having a constrained configuration and an expanded configuration and comprising:
an anchor assembly including a ventricular anchor, an atrial anchor, and a central portion therebetween, the ventricular and atrial anchors including struts that flare radially outwards relative to the central portion in the expanded configuration, at least some of the struts of the ventricular anchor further including hooks that extend radially outward in the expanded configuration; and
an annular strut frame positioned radially within the anchor assembly and attached thereto such that the strut frame extends farther distally than the ventricular anchor of the anchor assembly in the expanded configuration, 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 commissure plates attached to the strut frame, 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 extending inwards from outer edges of the commissure plate.

20. The prosthetic mitral valve of claim 19 , 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 commissure plate.

21. The prosthetic mitral valve of claim 19 , wherein the plurality of slots are in a portion of the strut frame that extends past the anchor assembly in the ventricular direction.

22. The prosthetic mitral valve of claim 19 , wherein the plurality of channels are substantially straight.

23. The prosthetic mitral valve of claim 19 , wherein there are between 6 and 12 channels in each commissure plate.

24. The prosthetic mitral valve of claim 19 , wherein each of the slots in in an axially extending strut.

25. The prosthetic mitral valve of claim 19 , wherein arms of the leaflets extend through the plurality of slots.

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

27. The prosthetic mitral valve of claim 19 , wherein the plurality of slots are positioned equidistance around a circumference of the strut frame.

28. The prosthetic mitral valve of claim 19 , wherein at least a portion of the leaflet arm is positioned radially between the anchor assembly and the strut frame.

Assignees

• Cephea Valve Tech Inc

Inventors

• Noe Spencer
• Wallace Dan
• Oakden Jonathan

Classifications

• A61F2250/0063

  Nested prosthetic parts · CPC title

• A61F2250/0039

  differing in diameter · CPC title

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title

• A61M39/22

  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)} · CPC title

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title