SPACER FOR SECURING A TRANSCATHETER VALVE TO A BIOPROSTHETIC CARDIAC STRUCTURE

• US 20170281337A1
• Filed: 04/21/2017
• Published: 10/05/2017
• Est. Priority Date: 09/02/2015
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Campbell, Louis A.
• Application Number:
  US15/494,239
• Publication Number:
  US 20170281337A1
• Time in Patent Office: 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers

Abstract

A spacer for creating a docking station for a transcatheter heart valve is provided. The spacer changes an effective diameter and/or a shape of an implanted bioprosthetic structure such as a bioprosthetic heart valve or annuloplasty ring, providing a supporting structure into which the transcatheter valve expands without over expanding. The spacer may be deployed through an interventional technique either through transseptal access, transfemoral access, or transapical access and is typically deployed at least in part on an inflow portion of the implanted bioprosthetic structure.

Claims

1. A spacer for implantation into a bioprosthetic cardiac structure such as a bioprosthetic heart valve or annuloplasty ring about a native valve, comprising:

a central flow axis having an upstream direction and a downstream direction, the downstream direction corresponding to the direction of blood flow from an upstream portion of the bioprosthetic cardiac structure through leaflets in a downstream portion of the valve when the spacer is implanted;

the spacer configured for percutaneous delivery and engageable with the bioprosthetic structure, the spacer having a transcatheter valve mounting surface;

the spacer further comprising a spacer shaft adapted to receive a transcatheter valve and providing a surface onto which the transcatheter valve may secure, the spacer having a first flange for mounting on an upstream portion of the bioprosthetic structure and a second flange for mounting on the bioprosthetic cardiac structure in the downstream direction relative to the first flange, the spacer shaft interconnecting the first flange and the second flange, the first flange having a dimension greater than the second flange and greater than an inner diameter of the bioprosthetic cardiac structure, the first and second flanges being rings;

wherein the bioprosthetic cardiac structure is one of a prosthetic heart valve and an annuloplasty ring.

2. A spacer for implantation into a bioprosthetic cardiac structure such as a bioprosthetic heart valve or annuloplasty ring about a native valve, comprising:

a central flow axis having an upstream direction and a downstream direction, the downstream direction corresponding to the direction of blood flow from an upstream portion of the bioprosthetic cardiac structure through leaflets in a downstream portion of the valve when the spacer is implanted;

the spacer configured for percutaneous delivery and engageable with the bioprosthetic structure, the spacer having a transcatheter valve mounting surface.

3. The spacer of claim 2, further comprising a spacer shaft adapted to receive a transcatheter valve and providing a surface onto which the transcatheter valve may secure.

4. The spacer of claim 2, wherein the spacer further comprises a first flange for mounting on an upstream portion of the bioprosthetic structure.

5. The spacer of claim 3, wherein the spacer further comprises a second flange for mounting on the bioprosthetic cardiac structure in the downstream direction relative to the first ring flange, the spacer shaft interconnecting the first flange and the second flange.

6. The spacer of claim 5, wherein the first flange has a dimension greater than the second flange and greater than an inner diameter of the bioprosthetic cardiac structure.

7. The spacer of claim 2, wherein the spacer comprises anchors for securing the spacer to the bioprosthetic heart valve.

8. The spacer of claim 7, wherein the second flange comprises the anchors.

9. The spacer of claim 2, wherein the spacer comprises a shape memory material and is self-expanding.

10. The spacer of claim 5, wherein the second flange is adapted to be secured to an inner diameter of a cylindrical space in an upstream portion of a bioprosthetic cardiac structure relative to valve leaflets that are in a downstream direction relative to the cylindrical space.

11. The spacer of claim 2, wherein at least a portion of the spacer is balloon-expandable.

12. The spacer ring of claim 2, wherein the spacer includes snares connected thereto to control expansion of the spacer.

13. The spacer of claim 2, wherein at least a portion of the spacer is covered with fabric.

14. The spacer of claim 2, wherein the spacer comprises a cobalt-chromium alloy.

15. The spacer of claim 2, wherein a portion of the spacer is adapted to secure to a stiffening band in a cylindrical space in the bioprosthetic cardiac structure.

16. The spacer of claim 3, wherein the spacer shaft is substantially cylindrical.

17. The spacer of claim 5, wherein the second flange is a ring.

18. The spacer of claim 4, wherein the first flange is a ring.

19. The spacer of claim 18 wherein the first flange is a ring having a non-circular configuration to adapt to a non-circular portion of the bioprosthetic cardiac structure.

20. The spacer of claim 2 wherein the spacer comprises sensors that communicate sensor data.

21. The spacer of claim 3 wherein a shaft into which a THV may dock is spring loaded.

22. The spacer of claim 3 wherein a shaft into which a THV may dock comprises a compressible surface.

23. The spacer of claim 2, wherein the bioprosthetic cardiac structure is a prosthetic heart valve.

24. The spacer of claim 2, wherein the bioprosthetic cardiac structure is an annuloplasty ring.

25-45. -45. (canceled)