Cardiac valve support structure

• US 10,105,224 B2
• Filed: 03/08/2013
• Issued: 10/23/2018
• Est. Priority Date: 09/01/2010
• Status: Expired due to Fees

• Current Assignee: Mvalve Technologies Ltd.
• Original Assignee: Mvalve Technologies Ltd.
• Inventors: Buchbinder, Maurice, Logan, Julie, Dubi, Shay, Tubishevitz, Amit, Eftel, Avi
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): Preston, Rebecca
• Application Number:
  US13/790,174
• Publication Number:
  US 20140005778A1
• Time in Patent Office: 2,055 Days
• 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 constructed from a biocompatible metal, each of said support elements having a collapsed delivery configuration and a deployed configuration;

and wherein only 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,

wherein said bridging members extend from locations on each of the support elements that are approximately 180 degrees apart from each other;

wherein at least one of the support elements in its deployed configuration is provided in the form of a flat annular ring having an outer radius (Ro) and an inner radius (Ri);

and wherein the difference between Ro and Ri significantly larger than a thickness of the at least one support element.

3. 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.

4. 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.

5. The cardiac valve support of claim 1 or claim 2, wherein the difference (Rd) between the outer radius (Ro) and the inner radius (Ri) is in the range of 1-14 mm.

6. The cardiac valve support of claim 5, wherein the ratio between Rd and a thickness of the flat annular ring is between 10:

1 and 20;

1.

7. The cardiac valve support of claim 5, 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.

8. The cardiac valve support of claim 5, wherein a thickness of the flat annular ring is in the range of 0.25-0.6 mm.

9. The cardiac valve support of claim 1 or claim 2, wherein said support 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.

10. 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 to the heart wall.

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

12. The cardiac valve support according to claim 11, 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.

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

a cardiac valve support according to claim 1 or claim 2; and

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

14. The system of claim 13, 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 constructed from a biocompatible metal, each of said support elements having a collapsed delivery configuration and a deployed configuration;

and wherein only 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,

wherein said bridging members extend from locations on each of the support elements that are approximately 180 degrees apart from each other;

wherein at least one of the support elements in its deployed configuration is provided in the form of a flat annular ring having an outer radius (Ro) and an inner radius (Ri);

and wherein the difference between Ro and Ri significantly larger than a thickness of the at least one support element.