Prosthetic heart valve devices and associated systems and methods

Patent metadata

Field	Value
Publication number	US-11877926-B2
Application number	US-202016944957-A
Country	US
Kind code	B2
Filing date	Jul 31, 2020
Priority date	Jul 6, 2017
Publication date	Jan 23, 2024
Grant date	Jan 23, 2024

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.

First claim

We claim:

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 only 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 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.

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

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

5. 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,
wherein the first material is radiopaque, and the second material is a superelastic alloy.

6. The device of claim 5 wherein the therapeutic agent includes at least one selected from the group consisting of an anti-inflammatory drug and a bioactive agent.

7. 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 selected from the group consisting of an anti-inflammatory drug and a bioactive agent.

8. 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.

9. The device of claim 5 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.

10. The device of claim 5 wherein the extension member further comprises an intermediate material positioned between the inner core and the outer material.

11. The device of claim 10 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.

12. The device of claim 10 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.

13. 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.

14. The device of claim 13 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.

15. The device of claim 13 wherein the wires are integral with the upstream portion of the fixation frame.

16. The device of claim 13 wherein the wires are mechanically isolated from the fixation frame.

17. The device of claim 13 wherein the first material is radiopaque, and the second material is a superelastic alloy.

18. The device of claim 13 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.

19. The device of claim 13 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.

20. The device of claim 13 wherein the extension member further comprises an intermediate material positioned between the inner core and the outer material.

21. The device of claim 20 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.

22. The device of claim 20 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.

Assignees

• Twelve Inc

Inventors

• Francis Richard
• Robertson Scott
• Lally Marian
• Hill Alexander
• Miyashiro Katherine
• Frisby Paraic
• Keogh James R

Classifications

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2/2412 Primary

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• A61F2210/0014

  using shape memory or superelastic materials, e.g. nitinol · CPC title

• A61F2250/0067

  Means for introducing or releasing pharmaceutical products into the body · CPC title

• A61F2250/0068

  the pharmaceutical product being in a reservoir · CPC title