Covering and assembly method for transcatheter valve

• US 10,631,977 B2
• Filed: 08/18/2016
• Issued: 04/28/2020
• Est. Priority Date: 08/24/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesicences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Tayeb, Liron, Tamir, Ilan
• Primary Examiner(s): Snow, Bruce E
• Application Number:
  US15/240,570
• Publication Number:
  US 20170056163A1
• Time in Patent Office: 1,349 Days
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A covering layer for a transcatheter heart valve is in various embodiments configured to prevent or reduce damage to the native valve tissue around the site where the prosthetic valve is implanted. In some cases, prosthetic valves are manufactured with the covering layer attached. Other covering layers are stand-alone accessories that can be mounted onto pre-existing prosthetic valves by an end user. Covering layers that can be mounted by an end user are provided with various features that can facilitate easier attachment of the covering layer to the prosthetic valve, which further reduces the possibility of damage to the covering layer or to the valve. Another covering is provided with two layers in order to insulate and protect the native tissue surrounding the implant from damage due to friction or abrasion, and/or other movement driven wear.

Claims

1. A valve prosthesis, comprising:

a radially expandable and collapsible frame and a plurality of valve leaflets positioned at least partially in the frame and configured to control blood flow through the valve prosthesis, wherein the frame has a first end defining an outflow end, a second end defining an inflow end, and an outer surface extending from the first end to the second end; and

a covering disposed around the outer surface of the frame and connected to the frame, the covering comprising loop portions extending along the inflow and outflow ends of the frame, the loop portions defining passageways extending along the loop portions, the covering further comprising a plurality of pre-positioned strings, threads, or sutures held in the loop portions such that the covering and the plurality of pre-positioned strings, threads, or sutures comprise a standalone accessory that is attachable to and separable from the frame by the plurality of pre-positioned strings, threads, or sutures, wherein the covering comprises a fold at least at the outflow end of the frame, and covers substantially all of the outer surface of the frame.

2. The valve prosthesis of claim 1, wherein the covering covers the first end, the second end, and the entire outer surface of the frame.

3. The valve prosthesis of claim 1, wherein the covering comprises pericardial tissue.

4. The valve prosthesis of claim 1, wherein the plurality of pre-positioned strings, threads, or sutures are held between a first covering layer and a second layer of the covering forming the loop portions.

5. The valve prosthesis of claim 1, wherein the covering extends beyond the outflow end of the frame such that the fold is located downstream of and axially spaced apart from the outflow end of the frame.

6. The valve prosthesis of claim 1, wherein:

the covering comprises a first edge adjacent the outflow end of the frame and a second edge adjacent the inflow end of the frame; and

the covering is folded over the outflow end of the frame such that the first edge of the covering is disposed inside the frame.

7. The valve prosthesis of claim 1, wherein the covering comprises a cloth layer.

8. The valve prosthesis of claim 1, wherein two ends of the covering are attached to one another such that the covering forms a tubular structure.

9. A prosthetic heart valve, comprising:

a radially expandable and collapsible frame having an inflow end and an outflow end;

a plurality of valve leaflets positioned at least partially in the frame and configured to control blood flow through the prosthetic heart valve; and

a covering disposed around the frame and connected to the frame, the covering comprising loop portions extending along the inflow and outflow ends of the frame, the loop portions defining passageways extending along the loop portions, the covering further comprising a string, thread, or suture pre-positioned in each loop portion such that the covering and the pre-positioned strings, threads, or sutures comprise a standalone accessory that is attachable to and separable from the frame by the pre-positioned strings, threads, or sutures.

10. The prosthetic heart valve of claim 9, wherein the loop portions comprise top and bottom edges of the covering folded over and connected to the covering to form overlapping regions that define the passageways.

11. The prosthetic heart valve of claim 9, wherein ends of the pre-positioned strings, threads, or sutures are tied together to connect the covering to the frame.

12. The prosthetic heart valve of claim 11, wherein the pre-positioned strings, threads, or sutures are tightened so that the covering forms perimeters at the inflow and outflow ends of the frame that are smaller than the inflow and outflow ends of the frame.

13. The prosthetic heart valve of claim 12, wherein apices of the frame at the inflow end of the frame and apices of the frame at the outflow end of the frame are covered by the covering.

14. The prosthetic heart valve of claim 9, wherein meeting ends of the covering are sutured together to form a seam extending between the loop portions.

15. The prosthetic heart valve of claim 14, wherein the seam extends between a first knot formed by a pre-positioned string, thread, or suture tied at the inflow end of the frame and a second knot formed by a pre-positioned string, thread, or suture tied at the outflow end of the frame.

16. A valve prosthesis, comprising:

a radially expandable and collapsible frame and a plurality of valve leaflets positioned at least partially in the frame and configured to control blood flow through the valve prosthesis, wherein the frame has a first end defining an outflow end, a second end defining an inflow end, and an outer surface extending from the first end to the second end; and

a covering disposed around the outer surface of the frame and connected to the frame, the covering comprising a plurality of pre-positioned strings, threads, or sutures coupled to the covering such that the covering and the plurality of pre-positioned strings, threads, or sutures comprise a standalone accessory that is attachable to and separable from the frame by the plurality of pre-positioned strings, threads, or sutures, wherein the covering comprises a fold at least at the outflow end of the frame, and covers substantially all of the outer surface of the frame;

wherein the covering comprises a first layer attached to the frame and a second layer positioned on an outer surface of the first layer and configured to slide or move along the outer surface of the first layer.