Devices and methods for reducing cardiac valve regurgitation

• US 9,474,605 B2
• Filed: 05/16/2013
• Issued: 10/25/2016
• Est. Priority Date: 05/16/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rowe, Stanton J., Schwartz, Robert, Van Tassel, Robert, Khalil, Vivian, Spinner, Erin, Zimmerman, Neil, Siegel, Alexander J.
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US13/895,572
• Publication Number:
  US 20130338763A1
• Time in Patent Office: 1,258 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• 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 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• 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 2/2433 using balloon catheter
• 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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. An implantable heart valve coaptation system for reducing regurgitation through the valve, comprising the following implantable elements:

an elongated flexible rail having a ventricular anchor on the distal end thereof adapted to anchor into tissue within a ventricle, wherein the flexible rail has a length sufficient to extend from the ventricular anchor in the ventricular tissue to a subclavian vein, the flexible rail being made of material suitable for implant in the human body;

a delivery catheter having a lumen through which the flexible rail passes, the delivery catheter being made of material suitable for implant in the human body;

a valve leaflet coaptation member fixed on a distal end of the delivery catheter having a bell-shaped cover with a first end open and a flexible inner support holding the first end open, the delivery catheter having a length sufficient to extend from the coaptation member positioned within the heart valve leaflets to the subclavian vein, the coaptation member being made of material suitable for implant in the human body; and

a locking collet on a proximal end of the delivery catheter for securing the axial position of the coaptation member and delivery catheter on the flexible rail, the locking collet being made of material suitable for implant in the human body, the locking collet and/or catheter being adapted to be subcutaneously anchored outside the subclavian vein.

2. The system of claim 1, wherein the locking collet includes a pair of internally threaded tubular grips each fixed to one of two separate sections of the delivery catheter and engaging a common externally threaded tubular shaft member, and act on a wedge member interposed between at least one of the grips and the flexible rail to securing the axial position of the coaptation member and delivery catheter on the flexible rail.

3. The system of claim 1, wherein the first end of the bell-shaped cover of the coaptation member is on a distal or ventricular side thereof.

4. The system of claim 3, wherein the second end of the bell-shaped cover has flow through openings.

5. The system of claim 1, wherein the flexible inner support comprises a flexible frame with struts emanating from a central collar and engaging the first end of the bell-shaped cover.

6. The system of claim 1, wherein the flexible inner support comprises a flexible frame with struts that extend substantially the length of the bell-shaped cover.

7. The system of claim 1, wherein the flexible inner support comprises a compressible foam member substantially filling the cover.

8. The system of claim 1, wherein the cover is formed of polycarbonate urethane.

9. An implantable heart valve coaptation system for reducing regurgitation through the valve, comprising the following implantable elements:

an elongated flexible rail having a ventricular anchor on the distal end thereof adapted to anchor into tissue within a ventricle, wherein the flexible rail has a length sufficient to extend from the ventricular anchor in the ventricular tissue to a subclavian vein, the flexible rail being made of material suitable for implant in the human body;

a delivery catheter having a lumen through which the flexible rail passes, the delivery catheter being made of material suitable for implant in the human body;

a valve leaflet coaptation member fixed on a distal end of the delivery catheter having a smooth outer cover with a compressible foam inner support, the delivery catheter having a length sufficient to extend from the coaptation member positioned within the heart valve leaflets to the subclavian vein, the coaptation member being made of material suitable for implant in the human body; and

a locking collet on a proximal end of the delivery catheter for securing the axial position of the coaptation member and delivery catheter on the flexible rail, the locking collet being made of material suitable for implant in the human body, the locking collet and/or catheter being adapted to be subcutaneously anchored outside the subclavian vein.

10. The system of claim 9, wherein the ventricular anchor comprises two separate anchors that cooperate to secure the flexible rail of the flexible rail to the ventricle tissue.

11. The system of claim 9, wherein the coaptation member is fixed over a section of the catheter having perforations opening to a lumen of the catheter.

12. The system of claim 11, wherein the cover provides a closed chamber around the perforations.

13. The system of claim 11, wherein the compressible foam member substantially fills the cover and is an open cell foam that permits blood flow therethrough.

14. The system of claim 13, wherein the flexible inner support further comprises a flexible frame with struts that extend substantially the length of the cover between the compressible foam member and the cover.

15. An implantable heart valve coaptation system for reducing regurgitation through the valve, comprising the following implantable elements:

an elongated flexible rail having a ventricular anchor on the distal end thereof adapted to anchor into tissue within a ventricle, wherein the flexible rail has a length sufficient to extend from the ventricular anchor in the ventricular tissue to a subclavian vein, the flexible rail being made of material suitable for implant in the human body;

a delivery catheter having a lumen through which the flexible rail passes, the delivery catheter being made of material suitable for implant in the human body;

a valve leaflet coaptation member fixed on a distal end of the delivery catheter over a section of the catheter having perforations opening to a lumen of the catheter, the coaptation member having an outer cover of polycarbonate urethane with a flexible inner support holding the cover outward from the delivery catheter, the outer cover providing a closed chamber around the perforations, and wherein the delivery catheter has a length sufficient to extend from the coaptation member positioned within the heart valve leaflets to the subclavian vein, the coaptation member being made of material suitable for implant in the human body; and

a locking collet on a proximal end of the delivery catheter for securing the axial position of the coaptation member and delivery catheter on the flexible rail, the locking collet being made of material suitable for implant in the human body, the locking collet and/or catheter being adapted to be subcutaneously anchored outside the subclavian vein.

16. The system of claim 15, wherein the cover is a polycarbonate urethane both ends being closed by being heat bonded to the catheter.

17. The system of claim 15, wherein the cover is bell-shaped with both ends secured to the catheter.

18. The system of claim 17, wherein the cover is a polycarbonate urethane with both ends heat bonded to the catheter.

19. The system of claim 15, wherein the flexible inner support comprises a compressible foam member substantially filling the cover.

20. The system of claim 15, wherein the flexible inner support comprises a flexible frame with struts emanating from a central collar and engaging the inside of the cover.

21. The system of claim 15, wherein the flexible inner support comprises a flexible frame with struts that extend substantially the length of the cover.