TRANSCATHETER VALVE PROSTHESIS

• US 20180125649A1
• Filed: 11/04/2016
• Published: 05/10/2018
• Est. Priority Date: 11/04/2016
• Status: Active Grant

• Current Assignee: HighLife SAS
• Original Assignee: HighLife SAS
• Inventors: NASR, Malek
• Granted Patent: US 11,376,121 B2
• Time in Patent Office: Days
• 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 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• 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 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability

Abstract

A heart valve system, the system including a radially self-expandable tubular body, a valve, and a tubular fabric. The tubular body having an inflow end and an outflow end. The valve being coupled to the tubular body and including a plurality of valve leaflets. The fabric being disposed on an outer surface of the tubular body, and the fabric having an inflow end and an outflow end. Furthermore, the outflow end of the fabric being directly connected to an outer circumferential edge of the valve.

Claims

1. A heart valve system comprising:

a radially self-expandable tubular body having an inflow end and an outflow end;

a valve coupled to the tubular body, the valve including a plurality of valve leaflets; and

a tubular fabric disposed on an outer surface of the tubular body, the fabric having an inflow end and an outflow end,

wherein the outflow end of the fabric is directly connected to an outer circumferential edge of the valve.

2. The system according to claim 1, wherein the valve is not directly connected to the tubular body.

3. The system according to claim 1, wherein the valve is directly connected to the tubular body.

4. The system according to claim 1, wherein the fabric is directly connected to the tubular body at the outflow end of the tubular body.

5. The system according to claim 4, wherein the fabric is directly connected to the outer circumferential edge of the valve and is directly connected to the tubular body with one or more sutures.

6. The system according to claim 4, wherein the connection between the fabric and the tubular body is located closer to the inflow end of the tubular body than the connection between the fabric and the outer circumferential edge of the valve.

7. The system according to claim 1, wherein the fabric does not wrap around the outflow end of the tubular body.

8. The system according to claim 1, wherein:

the tubular body includes a circumferential portion and one or more retaining components, and

the fabric surrounds the complete outer surface of the circumferential portion of the tubular body.

9. The system according to claim 8, wherein the outer circumferential edge of the valve is disposed distally of the circumferential portion of the tubular body in the outflow direction.

10. The system according to claim 8, wherein the outer circumferential edge of the valve does not radially overlap with the circumferential portion of the tubular body.

11. The system according to claim 1, further including a trapping member configured to form at least a partial loop encircling the tubular body to trap portions of native valve leaflets and/or chords.

12. The system according to claim 1, wherein the tubular body and the fabric are configured to assume an expanded configuration and a contracted configuration.

13. The system according to claim 1, wherein the valve leaflets extend distally of the outflow end of the tubular body in an outflow direction.

14. A method for manufacturing a heart valve, the method comprising:

directly connecting an outer circumferential edge of a valve with an outflow end of a tubular fabric to form a sub-assembly;

then, sliding a radially self-expandable tubular body into the sub-assembly; and

then, connecting the tubular body to the sub-assembly to form an assembly such that valve leaflets of the valve extend distally of an outflow end of the tubular body in an outflow direction.

15. The method according to claim 14, wherein the valve is not directly connected to the tubular body.

16. The method according to claim 14, wherein the valve is directly connected to the tubular body.

17. The method according to claim 14, further including directly connecting an outflow end of the tubular body with the fabric to form the sub-assembly.

18. The method according to claim 17, further including directly connecting the fabric to the outer circumferential edge of the valve and directly connecting the fabric to the tubular body with one or more sutures.

19. The method according to claim 17, wherein the connection between the fabric and the tubular body is located closer to an inflow end of the tubular body than the connection between the fabric and the outer circumferential edge of the valve.

20. The method according to claim 14, wherein the fabric does not wrap around the outflow end of the tubular body.

21. The method according to claim 14, wherein:

the tubular body includes a circumferential portion and one or more retaining components, and

the fabric surrounds the complete outer surface of the circumferential portion of the tubular body.