Systems and Methods for Heart Valve Therapy

• US 20160270911A1
• Filed: 03/17/2016
• Published: 09/22/2016
• Est. Priority Date: 03/19/2015
• Status: Active Grant

• Current Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Original Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Inventors: Ganesan, Kavitha, Venkatasubramanian, Ramji T., Schweich, Cyril J. Jr., Mortier, Todd J.
• Granted Patent: US 10,449,039 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2250/006 modular

Abstract

Prosthetic mitral valves described herein can be deployed using a transcatheter mitral valve delivery system and technique to interface and anchor in cooperation with the anatomical structures of a native mitral valve. This document describes prosthetic heart valve designs and techniques to manage blood flow through the left ventricular outflow tract. For example, this document describes prosthetic heart valve designs and techniques that reduce or prevent obstructions of the left ventricular outflow tract that may otherwise result from systolic anterior motion of an anterior leaflet of the native mitral valve.

Claims

1. A prosthetic mitral valve system comprising:

a valve assembly comprising an expandable valve frame and an occluder attached to the expandable valve frame; and

an anchor assembly comprising an expandable anchor frame, the anchor assembly configured to selectively couple with the valve assembly, the expandable anchor frame comprising a systolic anterior motion (SAM) containment member that is configured to be at least partially disposed behind an anterior leaflet of a native mitral valve when the expandable anchor frame is engaged with the native mitral valve.

2. The prosthetic mitral valve system of claim 1, wherein the anchor assembly comprises a plurality of sub-annular projections configured to engage tissue proximate to an annulus of the native mitral valve.

3. The prosthetic mitral valve system of claim 2, wherein a space is defined between an outwardly facing periphery of the valve assembly and the SAM containment member that is configured to loosely contain the anterior leaflet when the prosthetic mitral valve system is engaged with the native mitral valve.

4. The prosthetic mitral valve system of claim 1, wherein the SAM containment member comprises an elongate member with a first end that extends from a first portion of the expandable anchor frame and a second end that extends from a second portion of the expandable anchor frame.

5. The prosthetic mitral valve system of claim 4, wherein the SAM containment member further comprises an attachment element.

6. The prosthetic mitral valve system of claim 5, further comprising a delivery system for deploying the anchor assembly, wherein the delivery system comprises a catheter configured to engage with the attachment element.

7. The prosthetic mitral valve system of claim 5, further comprising a delivery system for deploying the anchor assembly, wherein the delivery system comprises a control wire configured to engage with the attachment element.

8. The prosthetic mitral valve system of claim 1, wherein the SAM containment member comprises an elongate member that extends from a hub of the expandable anchor frame, and wherein the elongate member defines a first width.

9. The prosthetic mitral valve system of claim 1, wherein the SAM containment member includes an end portion extending from the elongate member, wherein the end portion defines a second width that is greater than the first width of the elongate member, and wherein the end portion is configured to be disposed behind the anterior leaflet when the expandable anchor frame is engaged with the native mitral valve.

10. The prosthetic mitral valve system of claim 1, wherein the expandable anchor frame includes a single SAM containment member.

11. A prosthetic mitral valve system comprising:

an expandable frame with an occluder coupled thereto, wherein the expandable frame comprises a systolic anterior motion (SAM) containment member that is configured to be at least partially disposed behind an anterior leaflet of a native mitral valve when the expandable frame is engaged with the native mitral valve, the SAM containment member comprising an attachment element; and

a delivery system for transcatheter deployment of the expandable frame within the native mitral valve, wherein the delivery system is releasably coupleable with the attachment element.

12. The prosthetic mitral valve system of claim 11, wherein the attachment element comprises an eyelet.

13. The prosthetic mitral valve system of claim 12, wherein the eyelet includes eyelet threads, and wherein the delivery system comprises a member with threads that are complementary with the eyelet threads.

14. The prosthetic mitral valve system of claim 12, wherein the delivery system comprises a control wire that engages with the eyelet.

15. The prosthetic mitral valve system of claim 11, wherein the SAM containment member comprises an elongate member that extends from a hub of the expandable frame, and wherein the elongate member defines a first width.

16. The prosthetic mitral valve system of claim 15, wherein the SAM containment member includes an end portion extending from the elongate member, wherein the end portion defines a second width that is greater than the first width of the elongate member, and wherein the end portion is configured to be disposed behind the anterior leaflet when the expandable anchor frame is engaged with the native mitral valve.

17. The prosthetic mitral valve system of claim 11, wherein the expandable frame includes a single SAM containment member.

18. A method for deploying a prosthetic mitral valve system within a native mitral valve of a patient, the method comprising:

navigating a delivery sheath of a prosthetic mitral valve delivery system within the patient such that a distal end of the delivery sheath is positioned adjacent the native mitral valve;

expressing an anchor assembly of the prosthetic mitral valve system from the distal end of the delivery sheath such that the anchor assembly at least partially expands, the anchor assembly configured to selectively mate with a valve assembly of the prosthetic mitral valve system;

engaging the anchor assembly with the native mitral valve; and

after engaging the anchor assembly with the native mitral valve, deploying a systolic anterior motion (SAM) containment member such that the SAM containment member becomes at least partially disposed behind an anterior leaflet of the native mitral valve.

19. The method of claim 18, further comprising, after deploying the SAM containment member, mating the valve assembly with the anchor assembly.

20. The method of claim 18, further comprising, prior to deploying the SAM containment member, mating the valve assembly with the anchor assembly.

21. The method of claim 18, wherein when the anchor assembly is engaged with the native mitral valve, and prior to deploying the SAM containment member, native leaflets of the native mitral valve continue to function without significant interference from the anchor assembly.

22. The method of claim 18, wherein when the anchor assembly is engaged with the native mitral valve, and after deploying the SAM containment member, native leaflets of the native mitral valve continue to function without significant interference from the anchor assembly.

23. The method of claim 18, wherein the anchor assembly comprises one or more sub-annular support arms each having an anchor foot, and wherein engaging the anchor assembly with the native mitral valve comprises disposing each anchor foot within a sub-annular gutter of the native mitral valve.

24. The method of claim 18, further comprising mating the valve assembly with the anchor assembly, wherein the anterior leaflet is loosely contained between the SAM containment member and an exterior surface of the valve assembly.

25. The method of claim 18, wherein the SAM containment member is biased to be at least partially disposed behind the anterior leaflet, and wherein deploying the SAM containment member comprises detaching the SAM containment member from a member of the prosthetic mitral valve delivery system such that the SAM containment member is free to self-reconfigure to become at least partially disposed behind the anterior leaflet.

26. The method of claim 18, wherein deploying the SAM containment member comprises using a member of the prosthetic mitral valve delivery system to deflect the SAM containment member to be at least partially disposed behind the anterior leaflet.

27. A method for transcatheter deployment of a prosthetic mitral valve within a native mitral valve of a patient, the method comprising:

engaging the prosthetic mitral valve with the native mitral valve; and

after engaging the prosthetic mitral valve with the native mitral valve, deploying a systolic anterior motion (SAM) containment member of the prosthetic mitral valve such that the SAM containment member becomes at least partially disposed behind an anterior leaflet of the native mitral valve.

28. The method of claim 27, wherein the anterior leaflet is loosely contained between the SAM containment member and an exterior surface of the prosthetic mitral valve.

29. The method of claim 27, wherein the SAM containment member is biased to be at least partially disposed behind the anterior leaflet, and wherein deploying the SAM containment member comprises detaching the SAM containment member from a delivery system member such that the SAM containment member is free to self-reconfigure to become at least partially disposed behind the anterior leaflet.

30. The method of claim 27, wherein portions of the SAM containment member engage one or more lateral edges of the anterior leaflet or chordae to spread or widen the anterior leaflet to thereby restricting movement of the anterior leaflet.

31. An anchor assembly of a prosthetic mitral valve system, the anchor assembly comprising:

an expandable anchor frame that is adjustable between a radially compressed delivery condition and a radially expanded deployed condition in which the expandable anchor frame is configured to engage with a native mitral valve, the anchor assembly configured to selectively mate with a subsequently deliverable valve assembly of a prosthetic mitral valve system,

wherein the expandable anchor frame includes a systolic anterior motion (SAM) containment member that is configured to be at least partially disposed behind an anterior leaflet of the native mitral valve when the expandable anchor frame is engaged with the native mitral valve.

32. The anchor assembly of claim 31, wherein the SAM containment member comprises an elongate member with a first end that extends from a first portion of the expandable anchor frame and a second end that extends from a second portion of the expandable anchor frame.

33. The anchor assembly of claim 32, wherein the SAM containment member further comprises an attachment element configured to releasably engage with a portion of a delivery system.

34. The anchor assembly of claim 33, wherein the attachment element comprises an eyelet.

35. The anchor assembly of claim 31, wherein the SAM containment member comprises an elongate member that extends from a generally central, lower hub of the expandable anchor frame, and wherein the elongate member defines a first width.

36. The anchor assembly of claim 35, wherein the SAM containment member includes an end portion extending from the elongate member, wherein the end portion defines a second width that is greater than the first width of the elongate member, and wherein the end portion is configured to be disposed behind the anterior leaflet when the expandable anchor frame is engaged with the native mitral valve.

37. The anchor assembly of claim 31, wherein the expandable anchor frame includes a single SAM containment member.