Systems and methods for placing a coapting member between valvular leaflets

• US 9,636,223 B2
• Filed: 05/16/2013
• Issued: 05/02/2017
• Est. Priority Date: 05/16/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Khalil, Vivian, Spinner, Erin, Zimmerman, Neil, Nguyen, Son V., Siegel, Alexander
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US13/895,611
• Publication Number:
  US 20130325110A1
• Time in Patent Office: 1,447 Days
• Field of Search: 623 211
• CPC Class Codes: A61F 2/2424 Ball valves
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• 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 2210/0061 swellable
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.

Claims

1. A beating heart method of delivering a coaptation member to a position within native tricuspid heart valve leaflets to reduce regurgitation therethrough, comprising:

advancing a ventricular anchor on a distal end of a flexible rail from above the native tricuspid annulus into the right ventricle;

anchoring the ventricular anchor within the right ventricle;

advancing a coaptation member on a distal end of a delivery catheter over the flexible rail until the coaptation member is positioned within the native tricuspid heart valve leaflets, wherein the coaptation member comprises a plurality of elongated members in contact with one another along their lengths and held together at opposite ends, the elongated members being capable of repositioning with respect to one another from external forces;

adjusting the position of the coaptation member within the tricuspid annulus under visualization to reduce regurgitation through the tricuspid valve;

locking the position of the delivery catheter relative to the flexible rail by clamping a locking collet carried by the catheter onto the flexible rail; and

subcutaneously securing the locking collet immediately outside the subclavian vein.

2. The method of claim 1, wherein the locking collet includes two internally threaded tubular grips each attached to separate sections of the delivery catheter and engaging a common externally threaded tubular shaft member through which the flexible rail passes, and a tubular wedge member interposed between the tubular shaft member and the flexible rail, wherein clamping the locking collet onto the flexible rail comprises screwing the tubular grips toward each other over the tubular shaft member to cam the wedge member inward.

3. The method of claim 1, wherein the plurality of elongated members are covered with a sleeve of pericardium or biocompatible material.

4. The method of claim 1, wherein the plurality of elongated members comprise thin balloons that are individually inflatable and deflatable.

5. The method of claim 4, further including an inflation medium for the plurality of elongated members that is fluid at time of inflation and cures into a solid or semi-solid over time.

6. The method of claim 1, wherein the plurality of elongated members comprise tubes.

7. The method of claim 1, further including adding or deleting elongated members as needed to reduce regurgitation through the tricuspid valve.

8. A beating heart method of delivering a coaptation member to a position within native tricuspid heart valve leaflets to reduce regurgitation therethrough, comprising:

advancing a ventricular anchor on a distal end of a flexible rail from above the native tricuspid annulus into the right ventricle;

advancing a first catheter having a balloon thereon over the flexible rail until the balloon is positioned substantially within the tricuspid heart valve leaflets;

inflating the balloon on the first catheter to center the flexible rail within the tricuspid annulus;

further advancing the flexible rail until the ventricular anchor is located approximately at the apex of the right ventricle, and anchoring the ventricular anchor within the right ventricle;

advancing a coaptation member on a second catheter over the flexible rail until the coaptation member is positioned within the native tricuspid heart valve leaflets, wherein the second catheter includes a pair of relatively flexible regions directly proximal and distal to the coaptation member and a distal section of the second catheter locks down on the flexible rail,

adjusting the position of the coaptation member within the tricuspid annulus under visualization to reduce regurgitation through the tricuspid valve, wherein the step of adiusting the position of the coaptation member within the tricuspid annulus includes advancing and compressing the second catheter to cause the two flexible sections to buckle and displace the coaptation member laterally with respect to an axis of the second catheter; and

locking the position of the coaptation member relative to the flexible rail.

9. The method of claim 8, wherein a spring is provided on the flexible rail between the coaptation member and the ventricular anchor so that the coaptation member can move axially with respect to the tricuspid annulus from compression and expansion of the spring.

10. The method of claim 8, wherein the ventricular anchor comprises a pair of concentric corkscrew anchors, one having a clockwise orientation and the other having a counterclockwise orientation.

11. The method of claim 8, wherein the coaptation member comprises a frame formed from a plurality of struts that supports a bell-shaped tissue cover formed by one or more panels of bioprosthetic tissue or flexible polymer sewn around the struts of the frame, the coaptation member being open toward the right ventricle and closed toward the right atrium.

12. The method of claim 8, further including a pair of pull wires extending through the second catheter for altering the position of the coapting member within the tricuspid valve leaflets, wherein the step of adjusting the position of the coaptation member within the tricuspid annulus includes pulling one of the pull wires in conjunction with rotating the second catheter.

13. The method of claim 12, wherein the pull wires are connected to the coaptation member for angle adjustment of the coaptation member at the flexible region directly proximal to the coaptation member.

14. A beating heart method of delivering a coaptation member to a position within native tricuspid heart valve leaflets to reduce regurgitation therethrough, comprising:

advancing a ventricular anchor on a distal end of a flexible rail from above the native tricuspid annulus into the right ventricle;

anchoring the ventricular anchor within the right ventricle;

advancing a coaptation member on a distal end of a delivery catheter over the flexible rail until the coaptation member is positioned within the native tricuspid heart valve leaflets, wherein the coaptation member comprises a plurality of elongated members of circular cross-section in contact with one another along their lengths and held together at opposite ends, the elongated members being capable of repositioning with respect to one another from external forces;

securing the coaptation member on the delivery catheter to a point above the tricuspid annulus and within a direct line to the tricuspid annulus;

adjusting the position of the coaptation member within the tricuspid annulus under visualization to reduce regurgitation through the tricuspid valve;

adding or deleting elongated members to reduce regurgitation through the tricuspid valve; and

locking the position of the delivery catheter relative to the flexible rail.

15. The method of claim 14, wherein the coaptation member connects via a tether to a stent secured within a coronary sinus opening to the right atrium.

16. The method of claim 14, wherein the coaptation member on the delivery catheter is suspended within the annulus via flexible cables to a pair of anchors secured directly to the tricuspid annulus.

17. The method of claim 14, wherein the delivery catheter connects via an adjustable sleeve and a rod to an anchor secured within a coronary sinus opening to the right atrium, the adjustable sleeve and rod permitting adjustment of the relative positions of the anchor and the coaptation member.

18. The method of claim 14, wherein the delivery catheter connects directly to the superior vena cava via an anchor.

19. The method of claim 14, wherein the coaptation member connects via a connecting wire or rod to two stent structures, one expanded in the superior vena cava and the other in the inferior vena cava.

20. The method of claim 14, wherein the plurality of elongated members are covered with a sleeve of pericardium or biocompatible material.

21. The method of claim 14, wherein the plurality of elongated members comprise thin balloons that are individually inflatable and deflatable.

22. The method of claim 21, further including an inflation medium for the plurality of elongated members that is fluid at time of inflation and cures into a solid or semi-solid over time.

23. The method of claim 14, wherein the plurality of elongated members comprise tubes.