PROSTHETIC HEART VALVE DEVICES AND ASSOCIATED SYSTEMS AND METHODS

• US 20190008635A1
• Filed: 07/06/2017
• Published: 01/10/2019
• Est. Priority Date: 07/06/2017
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Francis, Richard, Robertson, Scott, Lally, Marian, Hill, Alexander, Miyashiro, Katherine, Frisby, Paraic, Keogh, James R.
• Granted Patent: US 10,729,541 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

The present technology is a prosthetic heart valve device, and related systems and methods, for treating a native valve of a human heart having a native annulus and native leaflets. One embodiment comprises a valve support, a prosthetic valve assembly within the valve support, and an anchoring member having an upstream portion and a downstream portion. The device further includes an extension member coupled to the fixation frame and extending radially outward therefrom. The extension member includes a plurality of wires, at least a portion of which include an inner core surrounded by an outer material. The wires include a plurality of recesses extending through at least a portion of the thickness of the outer material, and a therapeutic agent in the recesses for delivery to the anatomy when the prosthetic heart valve device is positioned at a native annulus.

Claims

1. A prosthetic heart valve device comprising:

an anchoring member having an annular fixation frame with an upstream portion and a downstream portion;

a tubular valve support having a first portion coupled to the downstream portion of the fixation frame and a second portion spaced radially inward from the upstream portion of the fixation frame;

a valve assembly coupled to the valve support and having at least one leaflet movable from a closed position in which blood flow is blocked through the valve support and an open position in which blood flow is allowed through the valve support in a downstream direction; and

an extension member coupled to the fixation frame and extending radially outward therefrom, wherein the extension member includes a plurality of wires, wherein at least a portion of the wires include an inner core surrounded by an outer material, and wherein (a) the inner core is a first material, (b) the outer material is a second material different than the first material and has a thickness, (c) the wires include a plurality of recesses extending through at least a portion of the thickness of the outer material, and (d) a therapeutic agent in the recesses for delivery to the anatomy when the prosthetic heart valve device is positioned at a native annulus.

2. The device of claim 1 wherein the upstream portion of the fixation frame is radially deformable without substantially deforming the second portion of the tubular valve support.

3. The device of claim 1 wherein the extension member further includes a sealing member extending along at least a portion of its length, and wherein the wires are coupled to the sealing member.

4. The device of claim 1 wherein the wires are integral with the upstream portion of the fixation frame.

5. The device of claim 1 wherein the wires are mechanically isolated from the fixation frame.

6. The device of claim 1 wherein the first material is radiopaque, and the second material is a superelastic alloy.

7. The device of claim 1 wherein the therapeutic agent includes at least one of an anti-inflammatory drug and a bioactive agent.

8. The device of claim 1 wherein:

the first material is radiopaque,

the second material is a superelastic alloy, and

the therapeutic agent includes at least one of an anti-inflammatory drug and a bioactive agent.

9. The device of claim 1 wherein at least some of the plurality of recesses extend through the entire thickness of the outer material, thereby exposing at least a portion of the inner core.

10. The device of claim 1 wherein at least some of the plurality of recesses extend through the entire thickness of the outer material and at least a portion of the thickness of the inner core such that the at least some of the plurality of recesses terminate at an intermediate depth within the inner core.

11. The device of claim 1 wherein the extension member further comprises an intermediate material positioned between the inner core and the outer material.

12. The device of claim 11 wherein at least some of the recesses extend through the entire thickness of the outer material, thereby exposing at least a portion of the intermediate material.

13. The device of claim 11 wherein at least some of the recesses extend through the entire thickness of the outer material and the entire thickness of the intermediate material, thereby exposing at least a portion of the inner core.

14. A prosthetic heart valve device comprising:

an anchoring member having an annular fixation frame with an upstream portion and a downstream portion;

a tubular valve support having a first portion coupled to the downstream portion of the anchoring member and a second portion spaced radially inward from the upstream portion of the anchoring member;

a valve assembly coupled to the valve support and having at least one leaflet movable from a closed position in which blood flow is blocked through the valve support and an open position in which blood flow is allowed through the valve support in a downstream direction; and

an extension member coupled to the fixation frame and extending radially outward therefrom, wherein the extension member includes a plurality of wires, wherein at least a portion of the wires include an inner core surrounded by an outer material, and wherein (a) the inner core is a first material, (b) the outer material is a second material different than the first material and has a thickness, (c) the wires include a plurality of recesses extending through at least a portion of the thickness of the outer material, and (d) a radiopaque material in the recesses.

15. The device of claim 14 wherein the upstream portion of the fixation frame is radially deformable without substantially deforming the second portion of the tubular valve support.

16. The device of claim 14 wherein the extension member further includes a sealing member extending along at least a portion of its length, and wherein the wires are coupled to the sealing member.

17. The device of claim 14 wherein the wires are integral with the upstream portion of the fixation frame.

18. The device of claim 14 wherein the wires are mechanically isolated from the fixation frame.

19. The device of claim 14 wherein the first material is radiopaque, and the second material is a superelastic alloy.

20. The device of claim 14 wherein the therapeutic agent includes at least one of an anti-inflammatory drug and a bioactive agent.

21. The device of claim 14 wherein:

the first material is radiopaque,

the second material is a superelastic alloy, and

the therapeutic agent includes at least one of an anti-inflammatory drug and a bioactive agent.

22. The device of claim 14 wherein at least some of the plurality of recesses extend through the entire thickness of the outer material, thereby exposing at least a portion of the inner core.

23. The device of claim 14 wherein at least some of the plurality of recesses extend through the entire thickness of the outer material and at least a portion of the thickness of the inner core such that the at least some of the plurality of recesses terminate at an intermediate depth within the inner core.

24. The device of claim 14 wherein the extension member further comprises an intermediate material positioned between the inner core and the outer material.

25. The device of claim 24 wherein at least some of the recesses extend through the entire thickness of the outer material, thereby exposing at least a portion of the intermediate material.

26. The device of claim 24 wherein at least some of the recesses extend through the entire thickness of the outer material and the entire thickness of the intermediate material, thereby exposing at least a portion of the inner core.

27. A prosthetic heart valve device comprising:

an anchoring member having a radially expandable frame with an interior and having an upstream portion and a downstream portion, wherein the upstream portion includes a tissue fixation portion configured to press outwardly against tissue located at and/or downstream of a native annulus of a heart valve in a subject and configured to be at least partially deformable to conform to a shape of the tissue;

a valve positioned relative to the anchoring member and having at least one leaflet movable from a closed position in which blood flow is blocked through the interior and an open position in which blood flow is allowed through the interior in a flow direction from the upstream portion toward the downstream portion, wherein the valve is spaced inwardly apart from the tissue fixation portion of the anchoring member such that the valve remains competent when the tissue fixation portion is deformed to conform to the shape of the tissue; and

an extension assembly extending laterally away from the upstream portion of the anchoring member in a deployed configuration, wherein the extension member comprises a plurality of discrete fabric segments having a first end at the anchoring member and a second end spaced apart from the anchoring member, wherein the fabric segments are arranged side-by-side around the extension member and adjacent fabric segments are loosely coupled together by a flexible coupling means such that the second ends of adjacent fabric segments can be configured independently of each other in the deployed state.

28. The prosthetic heart valve device of claim 27 wherein the segments do not include a structural member.

29. The prosthetic heart valve device of claim 27 wherein the extension member is configured to deform relative to the expandable frame in the deployed configuration.

30. The prosthetic heart valve device of claim 27 wherein the coupling means is elastic.

31. The prosthetic heart valve device of claim 27 wherein the coupling means is a suture.

32. The prosthetic heart valve device of claim 27 wherein the distal termini of the segments coincide with the second end of the extension member.

33. The prosthetic heart valve device of claim 27 wherein the segments are spaced apart from the expandable frame such that the segments are only indirectly coupled to the anchoring member.

34. The prosthetic heart valve device of claim 27 wherein the segments are directly connected to the expandable frame.