Cardiac Valve Support Structure

• US 20120059458A1
• Filed: 09/01/2011
• Published: 03/08/2012
• Est. Priority Date: 09/01/2010
• Status: Active Grant

• Current Assignee: Mvalve Technologies Ltd.
• Original Assignee: Mvalve Technologies Ltd.
• Inventors: Buchbinder, Maurice, Logan, Julie A.
• Granted Patent: US 9,301,836 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Cardiac valve supports and their methods of use.

Claims

1. A cardiac valve support adapted for endovascular delivery to a cardiac valve, comprising:

a first support element with a collapsed delivery configuration and a deployed configuration;

a second support element with a collapsed delivery configuration and a deployed configuration;

a first bridging member extending from the first support element to the second support element, wherein the first bridging member has a delivery configuration and a deployed configuration; and

a second bridging member extending from the first support element to the second support element, wherein the first bridging member has a delivery configuration and a deployed configuration;

wherein the first and second bridging members extend radially inward from the first and second support elements in the deployed configurations.

2. The cardiac valve support of claim 1 wherein the first and second bridging members extend from first and second discrete locations around the first and second support elements.

3. The cardiac valve support of claim 2 wherein the first and second bridging members symmetrically extend from the first and second support elements.

4. The cardiac valve support of claim 2 wherein the first and second bridging members extend from the first and second support elements about 180 degrees from one another.

5. The cardiac valve support of claim 1 wherein at least one of the first and second support elements has an annular shape.

6. The cardiac valve support of claim 1 wherein the first and second bridging members each have a replacement valve engagement portion adapted to securely engage a replacement heart valve.

7. The cardiac valve support of claim 6 wherein the engagements portions each have a locking element adapted to securely lock with a portion of a replacement heart valve.

8. The cardiac valve support of claim 1 wherein the first and second support elements are adapted to preferentially bend at least one location.

9. The cardiac valve support of claim 1 wherein the first and second support elements each have a curved portion in their deployed configurations, wherein the curved portions are adapted to assume a tighter curved configuration in the collapsed delivery configurations.

10. The cardiac valve support of claim 1 wherein the first and second bridging members are generally C-shaped in their deployed configurations.

11. The cardiac valve support of claim 1 wherein the first support element has at least one coupling element adapted to reversibly couple to a delivery system.

12. The cardiac valve support of claim 10 wherein the at least one coupling element is a threaded bore.

13. The cardiac valve support of claim 1 wherein the second support element has a dimension in the deployed configuration that is larger than a dimension of the first support element in the deployed configuration.

14. A system adapted for endovascular delivery to replace a mitral valve, comprising:

a cardiac valve support comprising

a first support element with a collapsed delivery configuration and a deployed configuration;

a second support element with a collapsed delivery configuration and a deployed configuration;

a first bridging member extending from the first support element to the second support element, wherein the first bridging member has a delivery configuration and a deployed configuration; and

a second bridging member extending from the first support element to the second support element, wherein the first bridging member has a delivery configuration and a deployed configuration;

wherein the first and second bridging members extend radially inward from the first and second support elements in the deployed configurations; and

a replacement heart valve comprising an expandable anchor and a plurality of leaflets adapted to be secured to the cardiac valve support.

15. The system of claim 14 wherein the bridging members are adapted to securingly engage the replacement heart valve.

16. A method of replacing a patient'"'"'s mitral valve, comprising:

endovascularly delivering a valve support to a location near a subject'"'"'s mitral valve, the valve support comprising a first support element, a second support element, and first and second bridging members extending from the first and second support elements;

expanding the first support element from a collapsed configuration to a deployed configuration secured against cardiac tissue below the plane of the mitral valve annulus;

expanding the bridge members from delivery configurations to deployed configurations positioned in general alignment with the coaptation points of the native mitral valve leaflets; and

expanding the second support element from a collapsed configuration to a deployed configuration secured against left atrial tissue above the plane of the mitral valve annulus.

17. The method of claim 16 wherein expanding the first support element comprises allowing the first support element to self-expand against cardiac tissue.

18. The method of claim 16 wherein expanding each of the bridge members comprises allowing the bridge members to assume a deployed configuration in which they extend radially inward from the first and second support elements.

19. The method of claim 16 wherein expanding the second support element against left atrial tissue comprises allowing the second support element to self-expand.

20. The method of claim 16 wherein expanding the first support element comprises expanding the first support element towards a generally annularly shaped deployed configuration.

21. The method of claim 16 wherein expanding the first support element comprises expanding the first support element secured against papillary tendons.

22. The method of claim 21 wherein expanding the first support element comprises expanding the first support element secured against papillary tendons without displacing them.

23. The method of claim 16 wherein native leaflets function after expanding the second support element.

24. The method of claim 16 wherein expanding the first support element occurs before expanding the second support element.

25. The method of claim 16 wherein expanding the bridge members comprises allowing the bridge members to symmetrically extend from the first support element to the second support element.

26. The method of claim 16 wherein expanding the bridge members comprises allowing the bridge members to extend from the first and second support elements about 180 degrees from one another.

27. The method of claim 16 wherein expanding the second support element comprises expanding the second support element to the deployed configuration in which the second support element has a dimension larger than a dimension of the first support element in the deployed configuration.

28. The method of claim 16 further comprising securing a replacement mitral valve to the valve support.

29. The method of claim 28 wherein securing the replacement mitral valve to the valve support comprises expanding the replacement mitral valve from a collapsed delivery configuration to an expanded configuration.

30. The method of claim 29 wherein expanding the replacement mitral valve comprises expanding the replacement mitral valve with a balloon.

31. The method of claim 29 wherein expanding the replacement mitral valve comprises allowing the replacement mitral valve to self-expand.

32. The method of claim 28 wherein securing a replacement mitral valve to the valve support comprises securing the replacement mitral valve radially within the valve support.

33. The method of claim 28 wherein securing a replacement mitral valve to the valve support comprises locking a replacement mitral valve element with a valve support element to lock the replacement mitral valve to the valve support.

34. The method of claim 33 wherein the bridge members each comprise a bridge lock element and the replacement mitral valve comprises a plurality of lock elements, and the locking step comprises locking one of the plurality of lock elements with one of the bridge lock elements and locking a second of the plurality of lock elements with the other of the bridge lock elements.