Devices for reducing cardiac valve regurgitation

• US 10,285,812 B2
• Filed: 10/18/2016
• Issued: 05/14/2019
• 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 M., Zimmerman, Neil S., Siegel, Alexander J.
• Primary Examiner(s): Fishback, Ashley L
• Application Number:
  US15/296,887
• Publication Number:
  US 20170035561A1
• Time in Patent Office: 938 Days
• 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 native leaflets of a target heart valve, comprising the following implantable elements:

a delivery catheter having a lumen, the delivery catheter being made of material suitable for implant in the human body the delivery catheter having a proximal anchor adapted to anchor into tissue located at one of either an annulus of the target heart valve, the inferior vena cava (IVC), or the right atrium (RA) and a length sufficient to extend from the proximal anchor to the target heart valve, a section of the catheter having perforations open to the lumen; and

a valve leaflet coaptation element fixed on a distal end of the delivery catheter over the section of the catheter having perforations, the coaptation element having an outer cover secured on proximal and distal ends to the catheter to provide a closed chamber around the perforations, and a plurality of flexible metallic struts that define a compressible/expandable inner frame structure within the outer cover such that the outer cover may alternately deform inward and spring outward with flow through the perforations, the coaptation element being made of material suitable for implant in the human body.

2. The system of claim 1, wherein the coaptation element defines an asymmetric shape along its longitudinal axis having an enlarged belly region just distal from a midline relative to a narrower proximal end.

3. The system of claim 2, wherein the coaptation element has a rounded triangular shape in radial section.

4. The system of claim 1, wherein the outer cover is formed of polycarbonate urethane, wherein the delivery catheter is also made of polycarbonate urethane and distal and proximal necks of the outer cover are heat bonded to the delivery catheter.

5. The system of claim 1, wherein the outer cover is formed of xenograft sheet tissue.

6. The system of claim 1, wherein the outer cover is formed of pericardial sheet.

7. The system of claim 1, wherein the inner frame structure extends substantially the length of the outer cover.

8. The system of claim 1, wherein the plurality of struts extend longitudinally and each have proximal and distal ends that are secured together and a mid-portion that arcs radially outward to extend substantially parallel to the axis of the coaptation element.

9. The system of claim 1, wherein there are at least six struts longitudinally formed of a super-elastic material.

10. The system of claim 1, further including:

an elongated flexible rail sized to pass through the delivery catheter lumen and having a length sufficient to extend at least from the proximal anchor to the target heart valve, the flexible rail 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 element and delivery catheter on the flexible rail, the locking collet being made of material suitable for implant in the human body.

11. The system of claim 10, wherein the flexible rail has a length sufficient to extend from the proximal anchor to a location within a ventricle to which the target heart valve opens, and further including a ventricular anchor on a distal end of the flexible rail for anchoring the flexible rail to ventricular tissue.

12. An implantable heart valve coaptation system for reducing regurgitation through native leaflets of a target heart valve, comprising the following implantable elements:

a delivery catheter having a lumen, the delivery catheter being made of material suitable for implant in the human body the delivery catheter having a proximal anchor adapted to anchor into tissue located at one of either an annulus of the target heart valve, the inferior vena cava (IVC), or the right atrium (RA) and a length sufficient to extend from the proximal anchor to the target heart valve, a section of the catheter having perforations open to the lumen; and

a valve leaflet coaptation element fixed on a distal end of the delivery catheter over the section of the catheter having perforations, the coaptation element having an outer cover secured on proximal and distal ends to the catheter to provide a closed chamber around the perforations, and a flexible inner support comprising a compressible foam member substantially filling the cover such that the outer cover may alternately deform inward and spring outward with flow through the perforations, wherein the coaptation element defines an asymmetric shape along its longitudinal axis having an enlarged belly region just distal from a midline relative to a narrower proximal end, the coaptation element being made of material suitable for implant in the human body.

13. The system of claim 12, wherein the coaptation element has a rounded triangular shape in radial section.

14. The system of claim 12, wherein the outer cover is formed of polycarbonate urethane, wherein the delivery catheter is also made of polycarbonate urethane and distal and proximal necks of the outer cover are heat bonded to the delivery catheter.

15. The system of claim 12, wherein the outer cover is formed of xenograft sheet tissue.

16. The system of claim 12, wherein the outer cover is formed of pericardial sheet.

17. The system of claim 12, wherein the compressible foam member extends substantially the length of the outer cover.

18. The system of claim 12, further including:

an elongated flexible rail sized to pass through the delivery catheter lumen and having a length sufficient to extend at least from the proximal anchor to the target heart valve, the flexible rail 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 element and delivery catheter on the flexible rail, the locking collet being made of material suitable for implant in the human body.

19. The system of claim 12, wherein the flexible rail has a length sufficient to extend from the proximal anchor to a location within a ventricle to which the target heart valve opens, and further including a ventricular anchor on a distal end of the flexible rail for anchoring the flexible rail to ventricular tissue.