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

• US 10,653,524 B2
• Filed: 09/12/2018
• Issued: 05/19/2020
• 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., Klenk, Alan R., Tun, Zaya, Snyder, Brett
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US16/129,194
• Publication Number:
  US 20190076249A1
• Time in Patent Office: 615 Days
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00358 Snares for grasping
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 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 2250/0004 adjustable

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 delivery system for treating mal-coaptation of a heart valve, the heart valve having an annulus, the coaptation assistance element delivery system comprising:

a 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, the coaptation assistance element comprising a hub;

a first anchor disposed within a first anchor housing, the first anchor configured to extend through the hub to engage the annulus; and

a release wire extending through the first anchor housing and configured to be positioned adjacent to the annulus.

2. The coaptation assistance element delivery system of claim 1, further comprising a radiopaque marker.

3. The coaptation assistance element delivery system of claim 2, further comprising a second anchor tether extending through the coaptation assistance element and around the release wire.

4. The coaptation assistance element delivery system of claim 3, wherein the radiopaque marker is crimped to the second anchor tether.

5. The coaptation assistance element delivery system of claim 2, wherein the radiopaque marker is configured for visual confirmation of an anchoring depth of a second anchor.

6. The coaptation assistance element delivery system of claim 1, further comprising a second anchor.

7. The coaptation assistance element delivery system of claim 6, wherein the second anchor comprises a first helical portion having a first pitch and a second helical portion having a second, smaller pitch.

8. The coaptation assistance element delivery system of claim 7, wherein the second helical portion is configured to lock with the coaptation assistance element.

9. The coaptation assistance element delivery system of claim 6, wherein the second anchor includes a locking segment and an anchoring segment, the locking segment comprising having a smaller pitch than the anchoring segment.

10. The coaptation assistance element delivery system of claim 6, wherein the second anchor is configured to be delivered by sliding the second anchor along a second anchor tether looped around the release wire.

11. The coaptation assistance element delivery system of claim 6, wherein the second anchor is configured to be delivered by sliding the second anchor along a second anchor guide rail, wherein the second anchor guide rail guides the trajectory of the second anchor.

12. The coaptation assistance element delivery system of claim 6, wherein the second anchor is configured to be rotated to engage the annulus.

13. The coaptation assistance element delivery system of claim 6, wherein the second anchor is configured to have two or more trajectories.

14. The coaptation assistance element delivery system of claim 6, wherein the trajectory of the second anchor is determined by the orientation of a respective second anchor guide rail.

15. The coaptation assistance element delivery system of claim 1, further comprising a first anchor driver disposed within the first anchor housing, wherein the first anchor driver is configured to rotate, but not translate, relative to the first anchor housing.

16. The coaptation assistance element delivery system of claim 1, further comprising a second anchor guide rail.

17. The coaptation assistance element delivery system of claim 16, wherein the second anchor guide rail is configured to lock a second anchor driver to a second anchor.

18. The coaptation assistance element delivery system of claim 16, wherein the second anchor guide rail is configured to slide along a second anchor tether to deliver a second anchor.

19. The coaptation assistance element delivery system of claim 16, wherein the second anchor guide rail comprises a distal section with a bend between 30 and 90 degrees.

20. The coaptation assistance element delivery system of claim 19, wherein the bend determines the trajectory of a second anchor delivered along the second anchor guide rail.