Replacement mitral valves

• US 10,568,737 B2
• Filed: 03/01/2018
• Issued: 02/25/2020
• Est. Priority Date: 01/23/2017
• Status: Active Grant

• Current Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories Incorporated)
• Inventors: Noe, Spencer, Wallace, Dan, Oakden, Jonathan
• Primary Examiner(s): Prone, Christopher D.
• Application Number:
  US15/909,610
• Publication Number:
  US 20180206984A1
• Time in Patent Office: 726 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 there between. 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:

an anchor assembly comprising a ventricular anchor, an atrial anchor, and a central portion there between, the anchor assembly having an expanded configuration in which the ventricular anchor and the atrial anchor flare radially outwards relative to the central portion, further wherein the atrial anchor includes a plurality of atrial cells and the ventricular anchor includes a plurality of ventricular cells;

an annular strut frame disposed radially within the anchor assembly, wherein a first plurality of the atrial cells are positioned radially inwards relative to a second plurality of the atrial cells such that the first plurality of the atrial cells and the second plurality of the atrial cells radially overlap, and wherein the first plurality of atrial cells attach the strut frame to the anchor assembly; and

a plurality of replacement leaflets secured to the annular strut frame.

2. The prosthetic mitral valve of claim 1, wherein the central portion is configured to align with a native valve orifice, and wherein the ventricular anchor and the atrial anchor are configured to compress native cardiac tissue there between.

3. The prosthetic mitral valve of claim 1, wherein an atrial end of the strut frame is attached to the anchor assembly.

4. The prosthetic mitral valve of claim 1, wherein atrial tips of the strut frame are attached to the anchor assembly.

5. The prosthetic mitral valve of claim 1, wherein an atrial end of the strut frame is flared radially outwards.

6. The prosthetic mitral valve of claim 5, wherein a flare of the strut frame is configured to substantially conform to the flare of the atrial anchor.

7. The prosthetic mitral valve of claim 1, wherein a ventricular end of the strut frame is spaced away from the anchor assembly.

8. The prosthetic mitral valve of claim 7, wherein the ventricular end of the strut frame is spaced away from the anchor assembly by a radial distance of 1-15mm.

9. The prosthetic mitral valve of claim 1, wherein the anchor assembly and the strut frame are configured to self-expand from a constrained configuration to an expanded configuration.

10. The prosthetic mitral valve of claim 1, wherein the strut frame is attached to the anchor assembly with a plurality of rivets.

11. The prosthetic mitral valve of claim 1, wherein the first plurality of atrial cells end in apexes that are attached to the strut frame.

12. The prosthetic mitral valve of claim 11, wherein the apexes are radially aligned with outer-most tips of the second plurality of atrial cells.

13. The prosthetic mitral valve of claim 1, wherein the first plurality of atrial cells is angled at approximately 70-80 degrees relative to an axis that extends through the central portion.

14. The prosthetic mitral valve of claim 13, wherein the second plurality of atrial cells is angled at approximately 20-30 degrees relative to the axis that extends through the central portion.

15. The prosthetic mitral valve of claim 1, wherein the annular strut frame flares radially outwards at 70-80 degrees relative to the axis that extends through the central portion.

16. A prosthetic mitral valve comprising:

an anchor assembly comprising a ventricular anchor, an atrial anchor, and a central portion therebetween, the anchor assembly having an expanded configuration in which the ventricular anchor and the atrial anchor flare radially outwards relative to the central portion, further wherein the atrial anchor includes a plurality of atrial cells;

an annular strut frame disposed radially within the anchor assembly, wherein a first plurality of the atrial cells are interior apexes and a second plurality of atrial cells are outermost atrial cells, the first plurality of the atrial cells positioned radially inwards relative to the second plurality of the atrial cells such that the first plurality of the atrial cells and the second plurality of the atrial cells radially overlap, and wherein the interior apexes of the first plurality of atrial cells attach the strut frame to the anchor assembly; and

a plurality of replacement leaflets secured to the annular strut frame.

17. The prosthetic mitral valve of claim 16, wherein the central portion is configured to align with a native valve orifice.

18. The prosthetic mitral valve of claim 16, wherein the ventricular anchor and the atrial anchor are configured to compress native cardiac tissue there between.

19. The prosthetic mitral valve of claim 16, wherein an atrial end of the strut frame is attached to the anchor assembly.

20. The prosthetic mitral valve of claim 16 wherein atrial tips of the strut frame are attached to the anchor assembly.

21. The prosthetic mitral valve of claim 16, wherein an atrial end of the strut frame is flared radially outwards.

22. The prosthetic mitral valve of claim 21, wherein a flare of the strut frame is configured to substantially conform to the flare of the atrial anchor.

23. The prosthetic mitral valve of claim 16, wherein a ventricular end of the strut frame is spaced away from the anchor assembly.

24. The prosthetic mitral valve of claim 23, wherein the ventricular end of the strut frame is spaced away from the anchor assembly by a radial distance of 1-15mm.

25. The prosthetic mitral valve of claim 16, wherein the anchor assembly and the strut frame are configured to self-expand from a constrained configuration to an expanded configuration.

26. The prosthetic mitral valve of claim 16, wherein the strut frame is attached to the anchor assembly with a plurality of rivets.

27. The prosthetic mitral valve of claim 16, wherein the apexes are radially aligned with outer-most tips of the second plurality of atrial cells.

28. The prosthetic mitral valve of claim 16, wherein the first plurality of atrial cells is angled at approximately 70-80 degrees relative to an axis that extends through the central portion.

29. The prosthetic mitral valve of claim 28, wherein the second plurality of atrial cells is angled at approximately 20-30 degrees relative to the axis that extends through the central portion.

30. The prosthetic mitral valve of claim 28, wherein the annular strut frame flares radially outwards at 70-80 degrees relative to the axis that extends through the central portion.