COVERING AND ASSEMBLY METHOD FOR TRANSCATHETER VALVE

• US 20170056163A1
• Filed: 08/18/2016
• Published: 03/02/2017
• Est. Priority Date: 08/24/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesicences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Tayeb, Liron, Tamir, Ilan
• Granted Patent: US 10,631,977 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 transcatheter heart valve comprising:

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, a second end, and an outer surface extending from the first end to the second end; and

a covering connected to the valve prosthesis, wherein the covering covers at least the first end and substantially all of the outer surface of the frame.

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

3. The transcatheter heart valve of claim 1, 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.

4. A covering for a valve prosthesis comprising a 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 of the valve prosthesis, a second end defining an inflow end of the valve prosthesis, and an outer surface extending from the first end to the second end, the covering comprising:

a covering layer configured to cover at least the outer surface of the frame at the first end; and

a plurality of strings connected to the covering layer, the strings configured to facilitate attachment of the covering layer to the valve prosthesis.

5. The covering of claim 4, wherein the covering layer is a cloth layer.

6. The covering of claim 4, wherein the covering layer comprises pericardial tissue.

7. The covering of claim 4, wherein the plurality of strings comprises a plurality of loops positioned at at least one end of the covering layer.

8. The covering of claim 7, wherein the plurality of loops positioned at a first end of the covering layer are held between the covering layer and a second layer of the covering.

9. The covering of claim 4, wherein the plurality of strings comprises a plurality of loops that are separable from the covering layer, and wherein each of the plurality of loops is positioned through an opening of the covering layer, such that at least a portion of the loop is positioned on each side of the covering layer.

10. The covering of claim 4, wherein two ends of the covering layer are attached to one another, such that the covering layer forms a tubular structure.

11. A system comprising:

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 of the valve prosthesis, a second end defining an inflow end of the valve prosthesis, and an outer surface extending from the first end to the second end; and

a covering separate from and attachable to the valve prosthesis for covering at least the outer surface of the frame at the first end, the covering comprising at least one string configured to facilitate attachment of the covering to the valve prosthesis.

12. The system of claim 11, wherein the frame further comprises a plurality of apices at at least one of the first end or the second end, and wherein the at least one string comprises a plurality of loops each configured to engage a corresponding apex of the frame.

13. The system of claim 12, wherein the plurality of loops is spaced apart from an end of the covering, such that when the loops are engaged with the corresponding apices of the frame, corners of the apices of the frame are covered by the covering.

14. The system of claim 11, wherein a height of the covering is shorter than a height of the frame measured from the first end to the second end.

15. The system of claim 11, wherein the at least one string comprises a plurality of loops that are separable from other parts of the covering, wherein each of the plurality of loops is positioned through an opening of the covering, such that at least a portion of the loop is positioned on each side of the opening.

16. The system of claim 15, wherein the covering is configured to be tied to the frame at a plurality of connection points, and wherein each of the plurality of loops is positioned on the covering based on a location of a corresponding connection point.

17. The system of claim 15, further comprising an anchor defining a through bore with a profile corresponding to a profile of the outer surface of the frame, wherein the covering is configured to be positioned between the frame and the anchor when the valve prosthesis is in the anchor.

18. A method for attaching a covering on a valve prosthesis, the valve prosthesis comprising a 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, a second end, and an outer surface extending from the first end to the second end, the covering comprising a covering layer and a plurality of loops, the method comprising:

mounting the covering layer around the outer surface of the valve prosthesis; and

attaching the covering layer to the valve prosthesis using the plurality of loops.

19. The method of claim 18, wherein the frame further comprises a plurality of apices at at least one of the first end or the second end, and wherein each of the plurality of loops is positioned around a corresponding apex of the frame to attach the covering layer to the valve prosthesis.

20. The method of claim 18, wherein the plurality of loops are separable from the covering layer, and wherein attaching the covering layer to the valve prosthesis comprises:

positioning the loops through the valve frame;

threading strings through the loops on an inner side of the valve prosthesis;

pulling the loops through the covering layer to thread the strings through the covering and to an outside of the valve prosthesis; and

tying the strings to attach the covering to the valve prosthesis.