CARDIAC VALVE SUPPORT DEVICE FITTED WITH VALVE LEAFLETS

• US 20160106539A1
• Filed: 05/27/2014
• Published: 04/21/2016
• Est. Priority Date: 05/29/2013
• Status: Abandoned Application

• Current Assignee: Mvalve Technologies Ltd.
• Original Assignee: Mvalve Technologies Ltd.
• Inventors: BUCHBINDER, Maurice, DUBI, Shay, TUBISHEVITZ, Amit, GEVA, Avner
• Application Number:
  US14/893,267
• Publication Number:
  US 20160106539A1
• 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 2/2412 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 2250/0059 temporary
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

The present invention provides a cardiac valve support device adapted for endovascular delivery to a cardiac valve, wherein said support device comprises either a single support element with valve leaflets connected thereto or two interconnected support elements having valve leaflets connected to one of said two elements. The invention further encompasses a two-stage method for implanting a replacement cardiac valve, wherein the first stage comprises delivering a valve support device fitted with one or more valve leaflets to a location near a subject'"'"'s cardiac valve, such that said valve leaflets fulfill the function previously fulfilled by the native valve.

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;

and wherein one of said support elements is fitted with one or more valve leaflets.

3. The cardiac valve support according to claim 1, wherein said support further comprises one or more stabilizing arms.

4. The cardiac valve support according to claim 1, wherein said support is fitted with three valve leaflets.

5. The cardiac valve support according to claim 1, wherein said support is fitted with two valve leaflets.

6. The cardiac valve support according to claim 1, wherein the one or more valve leaflets are constructed from a non-biological material.

7. The cardiac valve support according to claim 1, 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 1-20 mm.

8. The cardiac valve support according to 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 according to 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 according to claim 7, wherein the thickness of the flat annular ring is in the range of 0.25-0.8 mm.

2. A cardiac valve support adapted for endovascular delivery to a cardiac valve, comprising a single ring-shaped support element, wherein said support element has a collapsed delivery configuration and a deployed configuration, and wherein said support element is fitted with one or more valve leaflets.

11. A two-stage method for implanting a replacement cardiac valve,

wherein the first stage comprises delivering a valve support device comprising one or more support elements and one or more valve leaflets attached to one of said support elements, to a location near a subject'"'"'s cardiac valve, expanding said support element(s) from a collapsed delivery configuration to an expanded, deployed configuration secured against cardiac tissue in the region of the valve annulus, thereby permitting said valve leaflets to fulfill the function previously fulfilled by the native valve;

and wherein the second stage comprises deploying a replacement valve within the central space of said valve support and securing said valve thereto.

12. The method according to claim 11, wherein the valve support device comprises a single support element.

13. The method according to claim 11, wherein the valve support device comprises an upper support element and a lower support element mutually connected by two or more bridging elements, and wherein the step of expanding said support elements comprises expanding, in sequence, one of the support elements, the bridging elements and the second support element.

14. The method according to claim 11, wherein the cardiac valve to be replaced is the mitral valve.