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

• US 10,376,365 B2
• Filed: 03/10/2017
• Issued: 08/13/2019
• 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): Ulsh, George J
• Application Number:
  US15/455,562
• Publication Number:
  US 20170258590A1
• Time in Patent Office: 886 Days
• Field of Search: 623 211
• 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 heart, the coaptation assistance element comprising:

a first coaptation surface and an opposed second surface;

a first lateral edge, a second lateral edge, an inferior edge, and a superior edge;

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

an active anchor configured to couple 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 around the hub and extending outward from the hub, the plurality of struts comprising at least a first strut configured to be implanted within the heart and a second strut configured to be implanted within the heart such that the first coaptation surface coapts with a first leaflet of the heart valve and the opposed second surface overlays a second leaflet of the heart valve.

2. The coaptation assistance element of claim 1, wherein the second strut has a total length that is longer than a total length of the first strut.

3. The coaptation assistance element of claim 1, wherein the hub is an annular hub.

4. The coaptation assistance element of claim 1, further comprising a covering overlying a portion of the plurality of struts.

5. The coaptation assistance element of claim 4, wherein at least one strut of the plurality of struts has a sharpened tip extending from the covering.

6. The coaptation assistance element of claim 1, further comprising a suture, wherein the suture is configured collapse the coaptation assistance element.

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

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

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

10. The coaptation assistance element of claim 1, wherein the hub is configured to extend upward from an annulus of the heart valve.

11. The coaptation assistance element of claim 1, wherein the hub and the plurality of struts are formed from a tube.

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

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

a first coaptation surface and an opposed second surface;

a first lateral edge, a second lateral edge, an inferior edge, and a superior edge;

a hub;

an anchor configured to be coupled to the hub, the anchor configured to be rotated in a first direction relative to the hub to engage a tissue at a first target location, the 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 extending outward from the hub, the plurality of struts comprising at least a first strut configured to be implanted within the heart superior to the heart valve and a second strut configured to be implanted within the heart and traversing the heart valve.

14. The coaptation assistance element of claim 13, wherein two struts of the plurality of struts have different lengths.

15. The coaptation assistance element of claim 13, wherein at least one strut of the plurality of struts is bifurcated.

16. The coaptation assistance element of claim 13, wherein at least one strut of the plurality of struts comprise an eyelet.

17. The coaptation assistance element of claim 13, wherein at least one strut of the plurality of struts comprise a barb configured to be secured to a leaflet.

18. The coaptation assistance element of claim 13, wherein at least one strut of the plurality of struts comprise a portion configured to increase flexibility of the strut.

19. The coaptation assistance element of claim 13, further comprising a covering coupled to the plurality of struts.

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

a first coaptation surface and an opposed second surface;

a first lateral edge, a second lateral edge, an inferior edge, and a superior edge;

a hub;

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

a plurality of struts spaced around the hub and extending outward from the hub, the plurality of struts comprising at least a first strut configured to be implanted within the heart and a second strut configured to be implanted within the heart to position the annular anchor near the annulus.