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

• US 10,478,303 B2
• Filed: 02/14/2019
• Issued: 11/19/2019
• 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.
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US16/275,665
• Publication Number:
  US 20190175344A1
• Time in Patent Office: 278 Days
• 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 2017/00358 Snares for grasping
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/00871 polymeric
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• 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 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

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 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 extending downward from the superior zone,

wherein the inferior zone comprises a leaflet configured to move relative to the inferior edge such that a distance between the leaflet and the inferior edge is configured to increase during systole and configured to decrease during diastole.

2. The coaptation assistance element of claim 1, wherein the coaptation assistance element comprises a frame.

3. The coaptation assistance element of claim 2, wherein the leaflet is coupled to the frame.

4. The coaptation assistance element of claim 2, wherein the frame is nitinol.

5. The coaptation assistance element of claim 1, wherein the coaptation assistance element comprises an annular hub.

6. The coaptation assistance element of claim 1, wherein the coaptation assistance element comprises one or more chords coupling the leaflet to at least one edge.

7. The coaptation assistance element of claim 1, wherein the leaflet comprises biological tissue.

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

a first 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 extending downward from the superior zone,

wherein the inferior zone comprises a leaflet configured to expand such that a thickness of the leaflet is configured to increase during systole and a thickness of the leaflet is configured to decrease during diastole.

9. The coaptation assistance element of claim 8, wherein the coaptation assistance element comprises a frame.

10. The coaptation assistance element of claim 9, wherein the leaflet is coupled to the frame.

11. The coaptation assistance element of claim 9, wherein the frame is nitinol.

12. The coaptation assistance element of claim 8, wherein the coaptation assistance element comprises an annular hub.

13. The coaptation assistance element of claim 8, wherein the leaflet is inflatable.

14. The coaptation assistance element of claim 8, wherein the leaflet is inflated with hydrogel, collagen, or a polymer.

15. The coaptation assistance element of claim 8, wherein the leaflet configured to inflate and deflate with each heartbeat.

16. The coaptation assistance element of claim 8, wherein the leaflet comprises a balloon.