Replacement mitral valves

• US 10,470,881 B2
• Filed: 02/28/2018
• Issued: 11/12/2019
• Est. Priority Date: 05/14/2015
• 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.
• Assistant Examiner(s): Shipmon, Tiffany P
• Application Number:
  US15/908,701
• Publication Number:
  US 20180206983A1
• Time in Patent Office: 622 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:

an anchor assembly comprising a ventricular anchor, an atrial anchor, and a central portion therebetween, wherein the ventricular anchor and the atrial anchor are configured to flare radially outwards relative to the central portion;

an annular strut frame disposed radially within the anchor assembly, the annular strut frame attached to the anchor assembly at a plurality of attachment locations that are positioned between the central portion and an atrial-most edge of the anchor assembly; and

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

wherein 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.

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

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

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

5. The prosthetic mitral valve of claim 4, wherein a flare of the strut frame is configured to substantially conform to a flare of the atrial anchor.

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

7. The prosthetic mitral valve of claim 6, wherein the ventricular end of the strut frame is spaced away from the anchor assembly by a radial distance of 1-15 mm.

8. 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.

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

10. The prosthetic mitral valve of claim 9, wherein each of the plurality of attachment locations is radially aligned with tips of the atrial anchor.

11. The prosthetic mitral valve of claim 1, wherein the plurality of attachment locations are each part of the anchor assembly that extends further radially inwards than a remaining portion of the anchor assembly.

12. The prosthetic mitral valve of claim 1, wherein the anchor assembly comprises a plurality of diamond-shaped cells.

13. The prosthetic mitral valve of claim 12, wherein the plurality of attachment locations are positioned at a mid-point of the outermost atrial diamond-shaped cells.

14. The prosthetic mitral valve of claim 1, wherein the strut frame includes a plurality of linear struts and v-shaped connectors therebetween.

15. The prosthetic mitral valve of claim 1, wherein the anchor assembly forms a substantially hour-glass shape.

16. A prosthetic mitral valve comprising:

an anchor assembly comprising a ventricular anchor, an atrial anchor, and a central portion therebetween, wherein the ventricular anchor and the atrial anchor are configured to flare radially outwards relative to the central portion, further wherein the anchor assembly comprises a plurality of diamond-shaped cells;

an annular strut frame disposed radially within the anchor assembly, the annular strut frame attached to the anchor assembly at a plurality of attachment locations that are positioned at a mid-point of the outermost atrial diamond-shaped cells between the central portion and an atrial-most edge of the anchor assembly; and

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

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

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

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

20. The prosthetic mitral valve of claim 19, wherein a flare of the strut frame is configured to substantially conform to a flare of the atrial anchor.

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

22. The prosthetic mitral valve of claim 21, wherein the ventricular end of the strut frame is spaced away from the anchor assembly by a radial distance of 1-15 mm.

23. 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.

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

25. The prosthetic mitral valve of claim 16, wherein each of the plurality of attachment locations is radially aligned with tips of the atrial anchor.

26. The prosthetic mitral valve of claim 16, wherein the plurality of attachment locations are each part of the anchor assembly that extends further radially inwards than a remaining portion of the anchor assembly.

27. The prosthetic mitral valve of claim 16, wherein the strut frame includes a plurality of linear struts and v-shaped connectors therebetween.

28. The prosthetic mitral valve of claim 16, wherein the anchor assembly forms a substantially hour-glass shape.