System and method for cardiac valve repair and replacement

• US 10,154,906 B2
• Filed: 02/03/2017
• Issued: 12/18/2018
• Est. Priority Date: 07/17/2013
• Status: Active Grant

• Current Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories)
• Original Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories)
• Inventors: Granada, Juan F., Erzberger, Gary, Corcoran, Michael P., Wallace, Dan, Montorfano, Matteo, Chieffo, Alaide
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US15/424,742
• Publication Number:
  US 20170245991A1
• Time in Patent Office: 683 Days
• Field of Search: 623 211- 219
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped

Abstract

A method of delivering a prosthetic mitral valve includes delivering a distal anchor from a delivery sheath such that the distal anchor self-expands inside a first heart chamber on a first side of the mitral valve annulus, pulling proximally on the distal anchor such that the distal anchor self-aligns within the mitral valve annulus and the distal anchor rests against tissue of the ventricular heart chamber, and delivering a proximal anchor from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that the proximal anchor self-expands and moves towards the distal anchor to rest against tissue of the second heart chamber. The self-expansion of the proximal anchor captures tissue of the mitral valve annulus therebetween.

Claims

1. A prosthetic mitral valve comprising:

an anchor assembly comprising a ventricular anchor, a central portion, and an atrial anchor, wherein the ventricular anchor and the atrial anchor are both formed of a plurality of arcuate portions, the anchor assembly configured to self-expand from a collapsed configuration to an expanded configuration, the anchor assembly configured to foreshorten when self-expanding from the collapsed configuration to the expanded configuration such that the prosthetic mitral valve obtains an expanded length L that is less than a length of the prosthetic mitral valve in the collapsed configuration, further wherein the ventricular anchor and the atrial anchor are configured to flare outward relative to the central portion when self-expanding from the collapsed configuration to the expanded configuration such that the prosthetic mitral valve obtains an outermost diameter D that is greater than an outermost diameter of the prosthetic mitral valve in the collapsed configuration; and

a plurality of replacement leaflets secured to the anchor assembly;

wherein a ratio of D to L is greater than or equal to 2.

2. The prosthetic mitral valve of claim 1, wherein the plurality of leaflets comprise a biomaterial.

3. The prosthetic mitral valve of claim 1, wherein at least a portion of the anchor assembly is covered with a skirt configured to seal the prosthetic mitral valve during use.

4. The prosthetic mitral valve of claim 1, wherein the plurality of leaflets are arranged to fill an inner diameter of the prosthetic mitral valve.

10. The prosthetic mitral valve of claim 1, further comprising a plurality of retention hooks attached to the anchor assembly.

11. The prosthetic mitral valve of claim 10, wherein the plurality of retention hooks are attached only to the ventricular anchor.

13. The prosthetic mitral valve of claim 1, further comprising a plurality of struts attached to the anchor assembly and extending distally past the ventricular anchor when the anchor assembly is in the expanded configuration, the plurality of leaflets secured to the anchor assembly with the plurality of struts.

14. The prosthetic mitral valve of claim 1, wherein the central portion has a segment that extends substantially parallel to a longitudinal axis of the prosthetic mitral valve.

5. A prosthetic mitral valve comprising:

an anchor assembly comprising a ventricular anchor, a central portion, and an atrial anchor, the anchor assembly configured to self-expand from a collapsed configuration to an expanded configuration, the anchor assembly configured to foreshorten when self-expanding from the collapsed configuration to the expanded configuration such that the prosthetic mitral valve obtains an expanded length L that is less than a length of the prosthetic mitral valve in the collapsed configuration, further wherein the ventricular anchor and the atrial anchor are configured to flare outward relative to the central portion when self-expanding from the collapsed configuration to the expanded configuration such that the prosthetic mitral valve obtains an outermost diameter D that is greater than an outermost diameter of the prosthetic mitral valve in the collapsed configuration;

a plurality of replacement leaflets secured to the anchor assembly; and

a plurality of struts attached to the anchor assembly and extending distally past the ventricular anchor when the anchor assembly is in the expanded configuration, the plurality of leaflets secured to the anchor assembly with the plurality of struts;

wherein a ratio of D to L is greater than or equal to 2.

6. The prosthetic mitral valve of claim 5, wherein a ratio of an inner diameter of the central portion to a length of the plurality of struts is approximately 1.1 or greater.

7. The prosthetic mitral valve of claim 5, wherein the ratio of an inner diameter of the central portion to the length of the plurality of struts is approximately 1.3 or greater.

8. The prosthetic mitral valve of claim 5, wherein the plurality of struts includes three struts, the three struts located approximately 120 degrees away from one another.

15. The prosthetic mitral valve of claim 5, wherein at least a portion of the anchor assembly is covered with a skirt configured to seal the prosthetic mitral valve during use.

16. The prosthetic mitral valve of claim 5, wherein the central portion has a segment that extends substantially parallel to a longitudinal axis of the prosthetic mitral valve.

17. The prosthetic mitral valve of claim 5, further comprising a plurality of retention hooks attached to the anchor assembly.

18. The prosthetic mitral valve of claim 17, wherein the plurality of retention hooks are attached only to the ventricular anchor.

9. A prosthetic mitral valve comprising:

an anchor assembly comprising a ventricular anchor, a central portion, and an atrial anchor, wherein the central portion has a segment that extends substantially parallel to a longitudinal axis of the prosthetic mitral valve, the anchor assembly configured to self-expand from a collapsed configuration to an expanded configuration, the anchor assembly configured to foreshorten when self-expanding from the collapsed configuration to the expanded configuration such that the prosthetic mitral valve obtains an expanded length L that is less than a length of the prosthetic mitral valve in the collapsed configuration, further wherein the ventricular anchor and the atrial anchor are configured to flare outward relative to the central portion when self-expanding from the collapsed configuration to the expanded configuration such that the prosthetic mitral valve obtains an outermost diameter D that is greater than an outermost diameter of the prosthetic mitral valve in the collapsed configuration; and

a plurality of replacement leaflets secured to the anchor assembly;

wherein a ratio of D to L is greater than or equal to 2.

19. The prosthetic mitral valve of claim 9, wherein at least a portion of the anchor assembly is covered with a skirt configured to seal the prosthetic mitral valve during use.

20. The prosthetic mitral valve of claim 9, further comprising a plurality of retention hooks attached to the anchor assembly.

21. The prosthetic mitral valve of claim 20, wherein the plurality of retention hooks are attached only to the ventricular anchor.

12. A prosthetic mitral valve comprising:

an anchor assembly comprising a ventricular anchor, a central portion, and an atrial anchor, the anchor assembly configured to self-expand from a collapsed configuration to an expanded configuration, the anchor assembly configured to foreshorten when self-expanding from the collapsed configuration to the expanded configuration such that the prosthetic mitral valve obtains an expanded length L that is less than a length of the prosthetic mitral valve in the collapsed configuration, further wherein the ventricular anchor and the atrial anchor are configured to flare outward relative to the central portion when self-expanding from the collapsed configuration to the expanded configuration such that the prosthetic mitral valve obtains an outermost diameter D that is greater than an outermost diameter of the prosthetic mitral valve in the collapsed configuration;

a plurality of replacement leaflets secured to the anchor assembly; and

a plurality of retention hooks attached to the anchor assembly, wherein the plurality of retention hooks are curved such that, when the anchor assembly is in the collapsed configuration, the hooks flatten and collapse, and when the anchor assembly is in the expanded configuration, the hooks extend outwards; and

wherein a ratio of D to L is greater than or equal to 2.