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

• US 10,702,386 B2
• Filed: 11/09/2018
• Issued: 07/07/2020
• Est. Priority Date: 03/13/2017
• Status: Active Grant

• Current Assignee: Polares Medical Inc. (Polares Medical SA)
• Original Assignee: Polares Medical Inc. (Polares Medical SA)
• Inventors: Khairkhahan, Alexander K., Robinson, Janine C., Klenk, Alan R., Patel, Anuja, Tun, Zaya, Quintos, Robert, Snyder, Brett
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US16/185,419
• Publication Number:
  US 20190282358A1
• Time in Patent Office: 606 Days
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• 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, the heart valve having an annulus, the coaptation assistance element comprising:

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

a hub; 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 a heart superior to a valve annulus and a second strut configured to be implanted within a heart and traversing a plane of the valve annulus,

wherein the coaptation assistance element comprises a multi-layer laminate covering at least a portion of the plurality of struts.

2. The coaptation assistance element of claim 1, wherein at least one layer comprises ePTFE.

3. The coaptation assistance element of claim 1, wherein at least one layer comprises mesh.

4. The coaptation assistance element of claim 1, wherein at least one layer comprises fabric.

5. The coaptation assistance element of claim 1, wherein at least a portion of the first surface is reinforced with at least one layer.

6. The coaptation assistance element of claim 1, wherein at least a portion of the second surface is reinforced with at least one layer.

7. The coaptation assistance element of claim 1, wherein at least a portion of a ventricular surface is reinforced with at least one layer.

8. The coaptation assistance element of claim 1, wherein at least a portion of a coaptation surface is reinforced with at least one layer.

9. The coaptation assistance element of claim 1, wherein at least a portion of an anchor zone is reinforced with at least one layer.

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

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

a hub;

an anchor coupled to the hub and configured to be rotated relative to the hub to selectively deploy the 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 a heart superior to a valve annulus and a second strut configured to be implanted within a heart and traversing a plane of the valve annulus,

wherein the coaptation assistance element comprises at least two layers comprising different materials covering at least a portion of the plurality of struts.

11. The coaptation assistance element of claim 10, wherein the second strut has a total length that is longer than that of the first strut.

12. The coaptation assistance element of claim 10, wherein the hub is spaced radially inward from each of the first lateral edge, the second lateral edge, the inferior edge, and the superior edge.

13. The coaptation assistance element of claim 10, wherein the plurality of struts are spaced circumferentially around the hub.

14. The coaptation assistance element of claim 10, wherein at least one strut of the plurality of struts has a sharpened tip configured to engage tissue.

15. The coaptation assistance element of claim 10, wherein the plurality of struts comprise Nitinol.

16. The coaptation assistance element of claim 10, wherein the anchor is helical-shaped.

17. The coaptation assistance element of claim 10, further comprising one or more additional anchors.

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

19. The coaptation assistance element of claim 10, wherein the hub and the plurality of struts are integrally formed.

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

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

a hub;

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

a plurality of struts spaced around the hub, the plurality of struts comprising at least a first strut configured to be implanted within a heart superior to a valve annulus and a second strut configured to be implanted within a heart and traversing a plane of the valve annulus

wherein the coaptation assistance element comprises at least two layers comprising different dimensions covering at least a portion of the plurality of struts.