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

• US 10,123,874 B2
• Filed: 03/12/2018
• Issued: 11/13/2018
• Est. Priority Date: 03/13/2017
• Status: Active Grant

• Current Assignee: Polares Medical Inc. (Polares Medical SA)
• Original Assignee: Middle Peak Medical, Inc. (Boston Scientific Corporation)
• Inventors: Khairkhahan, Alexander K., Robinson, Janine C., Klenk, Alan R., Patel, Anuja, Tun, Zaya, Quintos, Robert, Snyder, Brett
• Primary Examiner(s): Stewart, Jason-Dennis
• Application Number:
  US15/918,988
• Publication Number:
  US 20180256318A1
• Time in Patent Office: 246 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 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; and

a superior zone and an inferior zone, the superior zone configured to reside in the plane of an annulus of the heart valve, the inferior zone comprising the first coaptation surface and the opposed second surface,

wherein the inferior zone comprises a laminate layer such that a thickness of the inferior zone is greater than a thickness of a portion of the superior zone.

2. The coaptation assistance element of claim 1, wherein the laminate layer comprises ePTFE.

3. The coaptation assistance element of claim 1, wherein the thickness of the inferior zone is at least about 25% thicker than the thickness of the portion of the superior zone.

4. The coaptation assistance element of claim 1, wherein the thickness of the inferior zone is at least about 50% thicker than the thickness of the portion of the superior zone.

5. The coaptation assistance element of claim 1, wherein a peripheral edge of the coaptation assistance element comprises a raised atraumatic edge surrounding only partially around the coaptation assistance element.

6. The coaptation assistance element of claim 5, wherein the raised atraumatic edge surrounds only the inferior zone of the coaptation assistance element.

7. The coaptation assistance element of claim 5, wherein the raised atraumatic edge comprises a suture.

8. The coaptation assistance element of claim 5, wherein the peripheral edge of the coaptation assistance element comprises spaced apart barbs extending radially outwardly from the peripheral edge of only the superior zone of the coaptation assistance element.

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

10. The coaptation assistance element of claim 1, wherein the coaptation assistance element comprises a layer of mesh.

11. A coaptation assistance element for treating mal-coaptation of a heart valve of a heart, the heart valve comprising native leaflets and an annulus, the coaptation assistance element comprising:

a body 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 spaced inward from each of the first lateral edge, the second lateral edge, the inferior edge, and the superior edge, the hub configured to reside near the annulus; and

a coaptation zone configured to provide a surface for at least one of the native leaflets to coapt against,

wherein the coaptation zone comprises a laminate layer such that a thickness of the coaptation zone is greater than a thickness of an unlaminated portion of the body superior to the coaptation zone.

12. The coaptation assistance element of claim 11, wherein the body comprises two or more layers.

13. The coaptation assistance element of claim 11, wherein the body comprises one or more layers of ePTFE.

14. The coaptation assistance element of claim 11, wherein at least one of the first lateral edge, the second lateral edge, the inferior edge, or the superior edge, or a portion thereof, further comprises a raised edge.

15. The coaptation assistance element of claim 11, wherein the first surface is a posterior layer and the opposed second surface is an anterior layer, wherein the laminate layer is disposed between the posterior layer and the anterior layer.

16. The coaptation assistance element of claim 11, further comprising a plurality of struts extending outward from the hub.

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

a body 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;

an annular zone and a ventricular zone, the annular zone configured to be located near the annulus of the heart valve, the ventricular zone extending from the annular zone and configured to be located near the posterior leaflet,

wherein the ventricular zone comprises at least one reinforcement layer such that a thickness of the ventricular zone is greater than a thickness of a portion of the annular zone.

18. The coaptation assistance element of claim 17, wherein the thickness of the at least one reinforcement layer is between 0.03″

and 0.05″

.

19. The coaptation assistance element of claim 17, wherein the at least one reinforcement layer comprises two layers.

20. The coaptation assistance element of claim 17, wherein the at least one reinforcement layer comprises at least one layer of ePTFE.