Systems and methods for transcatheter treatment of valve regurgitation

• US 10,166,098 B2
• Filed: 06/24/2014
• Issued: 01/01/2019
• 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.
• Primary Examiner(s): Lopez, Leslie
• Application Number:
  US14/313,975
• Publication Number:
  US 20150119981A1
• Time in Patent Office: 1,652 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• 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. A coaptation assist device for treating mal-coaptation of a heart valve, the heart valve having an annulus and posterior and anterior leaflets with an open configuration and a closed configuration, the coaptation assist device comprising:

a frame;

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

two or more ribbons configured to extend from the frame, each ribbon comprising a single longitudinal strip having a first end and a second end, wherein each ribbon has only one end coupled to the frame and the other end spaced from the frame and a fixed length therebetween, each ribbon forming a generally U-shaped configuration comprising a first portion extending from the first end, a curve, and a second portion extending from the curve to the second end, the two or more ribbons comprising a shape memory material having a preformed shape, each ribbon movable from a first compressed configuration to a second expanded configuration, wherein the second expanded configuration is a deployed configuration of the coaptation assist device, wherein the second portion extends radially outward from the first portion in the second expanded configuration, wherein the two or more ribbons are configured to provide a compressive force, the compressive force sufficient to secure the coaptation assist device,

wherein the coaptation assist device defines a height extending from an outflow end of the heart valve to an inflow end of the heart valve, wherein at least one ribbon of the two or more ribbons is a ventricular ribbon and substantially extends along the height of the coaptation assist device, the ventricular ribbon configured to extend along the posterior leaflet, wherein the body is coupled to the ventricular ribbon and substantially extends along the height of the coaptation assist device, wherein the height is the entire longitudinal length of the device,

wherein the body of the coaptation assist device is configured to be positioned to allow the anterior leaflet to coapt against the body of the coaptation assist device when the coaptation assist device is in the second expanded configuration and positioned over the posterior leaflet.

2. The coaptation assist device of claim 1, wherein at least one ribbon of the two or more ribbons comprises a nickel titanium alloy.

3. The coaptation assist device of claim 1, wherein at least one ribbon of the two or more ribbons is self-expanding.

4. The coaptation assist device of claim 1, wherein at least one ribbon of the two or more ribbons is configured to engage a left ventricle wall.

5. The coaptation assist device of claim 1, wherein at least one ribbon of the two or more ribbons resists movement of the coaptation assist device.

6. The coaptation assist device of claim 1, wherein the frame further comprises an annular anchor.

7. The coaptation assist device of claim 6, wherein the annular anchor comprises a plurality of barbs.

8. The coaptation assist device of claim 1, wherein the second portion comprises a rounded surface configured to abut tissue.

9. The coaptation assist device of claim 1, wherein at least one ribbon of the two or more ribbons is configured for ventricular attachment.

10. The coaptation assist device of claim 1, further comprising a helical atrial anchor.

11. A coaptation assist device for treating mal-coaptation of a heart valve, the heart valve having an annulus and posterior and anterior leaflets with an open configuration and a closed configuration, the coaptation assist device comprising:

a frame;

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

a plurality of elongate members configured to extend from the frame, each elongate member having a single connection with the frame and a fixed length, each elongate member forming a generally U-shaped configuration, the plurality of elongate members comprising a shape memory material having a preformed shape, each elongate member movable from a first compressed configuration to a second expanded configuration wherein an end expands radially outward from the frame, wherein the plurality of elongate members are configured to provide a compressive force, the compressive force sufficient to secure the coaptation assist device,

wherein the coaptation assist device defines a height extending from an outflow end of the heart valve to an inflow end of the heart valve, wherein at least one elongate member of the plurality of elongate members is an ventricular member and substantially extends along the height of the coaptation assist device, the ventricular member configured to extend along the posterior leaflet, wherein a portion of the body is affixed to the ventricular member, wherein the body substantially extends along the height of the coaptation assist device, wherein the ventricular member passes through a channel of the body,

wherein the body of the coaptation assist device is configured to be positioned to allow the anterior leaflet to coapt against the body of the coaptation assist device when the coaptation assist device is in the second expanded configuration and positioned over the posterior leaflet.

12. The coaptation assist device of claim 11, wherein at least one elongate member of the plurality of elongate members comprises a nickel titanium alloy.

13. The coaptation assist device of claim 11, wherein at least one elongate member of the plurality of elongate members is self-expanding.

14. The coaptation assist device of claim 11, wherein at least one elongate member of the plurality of elongate members is configured to engage a left ventricle wall.

15. The coaptation assist device of claim 11, wherein at least elongate member of the plurality of elongate members resists movement of the coaptation assist device.

16. The coaptation assist device of claim 11, wherein the frame further comprises an annular anchor.

17. The coaptation assist device of claim 16, wherein the annular anchor comprises a plurality of barbs.

18. The coaptation assist device of claim 11, wherein at least one elongate member of the plurality of elongate members is configured for ventricular attachment.

19. The coaptation assist device of claim 11, further comprising a helical atrial anchor.