SYSTEMS AND METHODS FOR TRANSCATHETER TREATMENT OF VALVE REGURGITATION

• US 20150119981A1
• Filed: 06/24/2014
• Published: 04/30/2015
• Est. Priority Date: 10/25/2013
• Status: Active Grant

• Current Assignee: Polares Medical Inc. (Polares Medical SA)
• Original Assignee: Middle Peak Medical, Inc. (Boston Scientific Corporation)
• Inventors: Khairkhahan, Alexander K., Lesh, Michael D., Klenk, Alan R.
• Granted Patent: US 10,166,098 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• 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 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• 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 2220/0008 Fixation appliances for connecting prostheses to the body

Abstract

The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance devices for implantation across the valve; a system including the coaptation enhancement element and anchors for implantation; a system including the coaptation enhancement element, and one or more of the following: transseptal sheath, anchor delivery catheter, implant delivery catheter, and clip delivery catheter; and methods for transcatheter implantation of a coaptation element across a heart valve.

Claims

1. An implant for treating mal-coaptation of a heart valve, the heart valve having an annulus and first and second leaflets with an open configuration and a closed configuration, the implant comprising:

a coaptation assist body having a first coaptation surface configured to be disposed to the posterior leaflet, an opposed second surface configured to be disposed toward the anterior leaflet;

at least one ribbon configured to extend from the coaptation assist body, the ribbon comprising a shape memory material having a preformed shape with at least one curve, the ribbon movable from a first compressed configuration to a second expanded configuration, wherein the ribbon is configured to provide a compressive force, the compressive force sufficient to secure the coaptation assist body in the vicinity of the native valve annulus.

2. The implant of claim 1, wherein the ribbon comprises a nitinol alloy.

3. The implant of claim 1, wherein the ribbon is self-expanding.

4. The implant of claim 1, further comprising a plurality of ribbons.

5. The implant of claim 1, wherein the ribbon is configured to engage the left ventricle wall.

6. The implant of claim 1, wherein the ribbon is configured to engage the posterior leaflet without engaging the anterior leaflet.

7. The implant of claim 1, wherein the ribbon resists movement of the implant.

8. The implant of claim 1, further comprising at least one eyelet configured to accept a portion of an anchor therethrough.

9. The implant of claim 8, further comprising a clip and pledget configured to secure the anchor to the coaptation assist body.

10. An implant for treating mal-coaptation of a heart valve, comprising:

an implant body configured to improve function of the heart valve, and at least one ribbon configured to extend from the implant body, the ribbon comprising a shape memory material having a preformed shape with at least one curve, the ribbon movable from a first compressed configuration to a second expanded configuration, wherein the ribbon is configured to provide a compressive force, the compressive force sufficient to secure the implant in the vicinity of the native valve annulus.

21. The implant of claim 10, further comprising an annular anchor operably connected to the implant body.

22. The implant of claim 21, wherein the annular anchor comprises a plurality of barbs for fixation to the surrounding tissue.

23. The implant of claim 10, wherein the ribbon curves and then extends upward, forming a generally U-shaped configuration.

24. The implant of claim 10, wherein the ribbon comprises a rounded top surface configured to abut tissue.

25. The implant of claim 10, wherein the ribbon is configured for ventricular attachment.

11-20. -20. (canceled)