CARDIAC VALVE SUPPORT STRUCTURE

• US 20140005778A1
• Filed: 03/08/2013
• Published: 01/02/2014
• Est. Priority Date: 09/01/2010
• Status: Active Grant

• Current Assignee: Mvalve Technologies Ltd.
• Original Assignee: Mvalve Technologies Ltd.
• Inventors: DUBI, Shay, BUCHBINDER, Maurice, LOGAN, Julie, TUBISHEVITZ, Amit, EFTEL, Avi
• Granted Patent: US 10,105,224 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• 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 2/2442 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 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

Cardiac valve supports and their methods of use.

Claims

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

first and second support elements each having a collapsed delivery configuration and a deployed configuration;

and wherein at least two bridging members extend from the first support element to the second support element, said bridging members having a delivery configuration and a deployed configuration, wherein said bridging members extend radially inward from the first and second support elements in the deployed configuration.

3. The cardiac valve support of claim 1 or claim 2, wherein the first and second bridging members extend from the first and second support elements about 180 degrees from one another.

4. The cardiac valve support of claim 1 or claim 2, wherein at least one of the first and second support elements has an annular shape.

5. The cardiac valve support of claim 1 or claim 2, wherein at least one of the first and second support elements has an outer perimeter that is entirely rigid.

6. The cardiac valve support of claim 1 or claim 2, wherein at least one portion of the inner perimeter of at least one of the support elements is elastically deformable in a radial direction.

7. The cardiac valve support of claim 1 or claim 2, wherein at least one of the support elements in its deployed configuration has the form of a flat annular ring, and wherein the difference (Rd) between the outer radius and the inner radius of said annular ring is in the range of 1-14 mm.

8. The cardiac valve support of claim 7, wherein the ratio between Rd and the thickness of the flat annular ring is between 10:

1 and 20;

1.

9. The cardiac valve support of claim 7, wherein the inner diameter of the flat annular ring is in the range of 23-29 mm and the outer diameter thereof is in the range of 30-50 mm.

10. The cardiac valve support of claim 7, wherein the thickness of the flat annular ring is in the range of 0.25-0.6 mm.

11. The cardiac valve support of claim 1 or claim 2, wherein said support device further comprises one or more extensions, attached to the bridging members or to one or both support elements, such that portion(s) of said one or more such extensions form a guidance element that is capable of centering a wire that is passed through the center of said support device.

12. The cardiac valve support of claim 1 or claim 2, wherein the bridging members and/or the support elements are fitted with heart tissue anchoring means adapted to securely anchor said support elements to the heart wall.

13. The cardiac valve support of claim 1 or claim 2, further comprising one or more intra-ventricular and/or intra-atrial stabilizing elements.

14. The cardiac valve support according to claim 13, wherein the stabilizing elements are selected from the group consisting of complete ring structures, partial rings, curved arms or wings, and elongate arms or wings.

15. The cardiac valve support of claim 1 or claim 2, comprising only two bridging members.

16. A system adapted for endovascular delivery or transapical delivery to replace a mitral valve, comprising:

a cardiac valve support according to any one of the previous claims; and

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

17. The system of claim 16, wherein the replacement heart valve is a prosthetic aortic valve.

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

first and second support elements each having a collapsed delivery configuration and a deployed configuration;

and wherein at least two bridging members extend from the first support element to the second support element, said bridging members having a delivery configuration and a deployed configuration, wherein said bridging members extend longitudinally, and without any appreciable radial curvature, between first and second support elements in the deployed configuration.

18. A method of replacing a patient'"'"'s mitral valve, comprising the steps of:

(a) 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 at least two bridging members extending from the first and second support elements;

(b) allowing the first support element to unfold from a collapsed configuration to a deployed configuration secured against cardiac tissue in the area of the mitral valve annulus;

(c) allowing the bridge members to unfold from their delivery configuration to their deployed configuration positioned in general alignment with the coaptation points of the native mitral valve leaflets; and

(d) allowing the second support element to unfold from a collapsed configuration to a deployed configuration secured against cardiac tissue in the area of the mitral valve annulus.

19. The method of claim 18, wherein native cardiac valve leaflet function is maintained throughout the procedure.

20. The method of claim 18, wherein the valve support is delivered either endovascularly or by the transapical route.

21. The method of claim 18, further comprising the step of causing anchoring and/or stabilizing means fitted to the support elements and/or bridging members to come into contact with cardiac tissue.

22. The method of claim 18 further comprising securing a prosthetic cardiac valve to the valve support.

23. The method of claim 22 wherein securing the prosthetic valve to the valve support comprises expanding said valve with a balloon.

24. The method of claim 22 wherein securing the prosthetic valve to the valve support comprises allowing said valve to self-expand.

25. The method of claim 22, wherein the prosthetic valve is delivered by the same route as the valve support.

26. The method of claim 22, wherein the prosthetic valve and the valve support are delivered by different routes.

27. The method of claim 22, wherein the prosthetic cardiac valve is a prosthetic aortic valve.