Device, system, and method for transcatheter treatment of valvular regurgitation

• US 9,592,121 B1
• Filed: 05/12/2016
• Issued: 03/14/2017
• Est. Priority Date: 11/06/2015
• Status: Active Grant

• Current Assignee: Polares Medical Inc. (Polares Medical SA)
• Original Assignee: Middle Peak Medical, Inc. (Boston Scientific Corporation)
• Inventors: Khairkhahan, Alexander K.
• Primary Examiner(s): Rosen, Eric
• Assistant Examiner(s): Ulsh, George J
• Application Number:
  US15/153,480
• Time in Patent Office: 306 Days
• Field of Search: 623/2.11
• US Class Current: 1/1
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance element for implantation across the valve; a system including the coaptation assistance element and anchors for implantation; a system including the coaptation assistance element and delivery catheter; and a method for transcatheter implantation of a coaptation element across a heart valve.

Claims

1. A coaptation assistance element for treating mal-coaptation of a heart valve of a heat, the heart valve having a valve annulus, the coaptation assistance element comprising:

a first coaptation surface and an opposed second surface, each of the first coaptation surface and the opposed second surface bounded by a first lateral edge, a second lateral edge, an inferior edge, and a superior edge, the superior edge forming a lip cupped downward toward the inferior edge or upward from the inferior edge;

a hub spaced radially inward from each of the first lateral edge, the second lateral edge, the inferior edge, and the superior edge; and

an active anchor coupled to the hub and configured to be rotated relative to the hub to selectively deploy the active anchor at a first target location; and

a plurality of struts spaced circumferentially around the hub and extending radially outward from the hub, the plurality of struts comprising at least a first strut configured to be implanted within the heart superior to the valve annulus and a second strut configured to be implanted within the heart and traversing a plane of the valve annulus, wherein the second strut has a total length that is longer than a total length of the first strut.

2. The coaptation assistance element of claim 1, wherein at least one strut of the plurality of struts has a sharpened tip configured to engage tissue.

3. The coaptation assistance element of claim 1, wherein the plurality of struts comprise Nitinol.

4. The coaptation assistance element of claim 1, wherein the active anchor is helical-shaped.

5. The coaptation assistance element of claim 1, further comprising one or more additional anchors.

6. The coaptation assistance element of claim 5, wherein the one or more additional anchors are active anchors.

7. The coaptation assistance element of claim 1, wherein the hub comprises a cross-pin configured to extend through a helix of the active anchor.

8. The coaptation assistance element of claim 1, wherein the hub is configured to mate with a delivery catheter, wherein the delivery catheter is configured to position the hub near the first target location.

9. The coaptation assistance element of claim 8, wherein the delivery catheter is configured to rotate the active anchor independently of the hub.

10. The coaptation assistance element of claim 1, further comprising a radiopaque marker.

11. The coaptation assistance element of claim 1, further comprising a plurality of radiopaque markers near the superior edge.

12. The coaptation assistance element of claim 1, wherein the lip is cupped downward toward the inferior edge.

13. The coaptation assistance element of claim 1, wherein the lip is cupped upward from the inferior edge.

14. The coaptation assistance element of claim 1, wherein the hub extends upward from the first coaptation surface.

15. The coaptation assistance element of claim 1, wherein the inferior edge curves backwards toward the hub.

16. The coaptation assistance element of claim 1, wherein the hub is tubular.

17. The coaptation assistance element of claim 1, wherein the plurality of struts and the hub are integrally formed.

18. The coaptation assistance element of claim 1, wherein the coaptation assistance element is configured to be collapsed relative to the hub.

19. The coaptation assistance element of claim 1, wherein the active anchor is configured to be selectively coupled and decoupled from tissue.

20. A coaptation assistance element for treating mal-coaptation of a heart valve of a heart, the heart valve having a valve annulus, the coaptation assistance element comprising:

a first coaptation surface and an opposed second surface, each of the first coaptation surface and the opposed second surface bounded by a first lateral edge, a second lateral edge, an inferior edge, and a superior edge,

a hub; and

an active anchor coupled to the hub, the active anchor configured to be rotated in a first direction relative to the hub to selectively deploy the active anchor at a first target location to engage a tissue, the active anchor configured to be rotated in a second direction, opposite the first direction, relative to the hub to selectively disengage the tissue at the first target location; and

a plurality of struts spaced circumferentially around the hub, the plurality of struts and the first coaptation surface extending radially outward from the hub, the plurality of struts comprising at least a first strut configured to be implanted within the heart superior to the valve annulus and a second strut configured to be implanted within the heart and traversing a plane of the valve annulus, wherein the second strut has a total length that is longer than a total length of the first strut.

21. A coaptation assistance element for treating mal-coaptation of a heart valve of a heart, the heart valve having a valve annulus, an anterior leaflet, and a posterior leaflet, the coaptation assistance element comprising:

a first coaptation surface and an opposed second surface, each of the first coaptation surface and the opposed second surface bounded by a first lateral edge, a second lateral edge, an inferior edge, and a superior edge;

a hub;

an active anchor coupled to the hub and configured to be rotated relative to the hub to selectively deploy the active anchor at a first target location, wherein the active anchor is configured to be selectively deployed in the annulus, wherein the hub is configured to remain stationary as the active anchor is rotated to engage tissue; and

a plurality of struts spaced circumferentially around the hub and extending radially outward from the hub, the plurality of struts comprising at least a first strut configured to be implanted within the heart superior to the valve annulus and a second strut configured to be implanted within the heart and traversing a plane of the valve annulus, wherein the second strut has a total length that is longer than a total length of the first strut.