Offset cardiac leaflet coaptation element

• US 10,105,226 B2
• Filed: 02/09/2016
• Issued: 10/23/2018
• Est. Priority Date: 02/10/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Zimmerman, Neil S.
• Primary Examiner(s): Louis, Richard
• Application Number:
  US15/019,706
• Publication Number:
  US 20160228246A1
• Time in Patent Office: 987 Days
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

Systems, devices, and methods for reducing regurgitation through an atrioventricular heart valve: i.e., the mitral valve and the tricuspid valve. The device includes a flexible anchor rail anchored in the tissue of the ventricle and an offset coaptation element on a catheter that rides over the anchor rail and is positionable between the valve leaflets. The proximal end of the coaptation catheter is fixed subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering over a foam interior, and is radially offset on the catheter so that the foam body projects away from the septal side of the valve to reduce or minimize deformation from contact with the septal wall of the ventricle. Markers on the coaptation element facilitate positioning in the desired rotational orientation during delivery and implant.

Claims

1. A heart valve coaptation system for reducing regurgitation through the valve, comprising:

a flexible rail having a ventricular anchor on a distal end thereof adapted to anchor into tissue within a ventricle;

a delivery catheter having a lumen defining a central axis through which the flexible rail passes and including a locking mechanism for fixing relative axial positions of the delivery catheter and flexible rail; and

a coaptation member fixed on a distal end of the delivery catheter having an outer cover surrounding a compressible inner filler member and a generally cylindrical shape, the compressible inner filler member being mounted on the delivery catheter so that a majority of the filler member is radially offset from the central axis of the delivery catheter and the delivery catheter lies along one radial side thereof to form an offset spine of the coaptation member, wherein

the compressible inner filler member is an open cell foam that fills the space between the delivery catheter and the outer cover, and wherein

there are two types of open cell foam, with a majority being a first foam and a significantly stiffer second foam positioned in a thin region along the one radial side between the delivery catheter and outer cover.

2. The system of claim 1, wherein the delivery catheter includes a series of perforations along a length that is located within the coaptation member to permit gas or fluid flow between pores in the filler member and an inner lumen of the catheter.

3. The system of claim 1, wherein the ventricular anchor includes a plurality of circumferentially distributed and distally-directed sharp tines or barbs that pierce the tissue within a ventricle.

4. The system of claim 1, wherein the coaptation member has a diameter in its uncompressed state of about 10 mm, while the delivery catheter has an outer diameter of 2-3 mm.

5. The system of claim 1, wherein the outer cover of the coaptation member is adhered around the delivery catheter so as to be closed on both ends and form a chamber outside of the delivery catheter.

6. The system of claim 5, wherein both the outer cover and the delivery catheter are made of the same material.

7. The system of claim 6, wherein both the outer cover and the delivery catheter are made of a polycarbonate-based thermoplastic polyurethane.

8. The system of claim 1, further including at least one radiopaque marker on the delivery catheter or coaptation member that shows up as different shapes for different rotational orientations when viewed with a fluoroscope.

9. The system of claim 8, wherein the at least one radiopaque marker comprises a pair of C-shaped radiopaque markers bonded to the delivery catheter at different locations.

10. A heart valve coaptation system for reducing regurgitation through the valve, comprising:

a flexible rail having a ventricular anchor on a distal end thereof adapted to anchor into tissue within a ventricle;

a delivery catheter having a lumen defining a central axis through which the flexible rail passes and including a locking mechanism for fixing relative axial positions of the delivery catheter and flexible rail; and

a coaptation member fixed on a distal end of the delivery catheter comprising a compressible member having a radial cross-sectional shape larger than a cross-section of the delivery catheter, the compressible member extending across a radial cross-section of the coaptation member and being configured to enable passive expansion of the coaptation member from a compressed state, the delivery catheter being mounted within the cross-sectional shape so as to lie along one diametric side thereof so that a majority of the compressible member is axially offset from a central axis of the delivery catheter, the delivery catheter being formed of a material that is relatively stiffer than the compressible member to form a spine while the compressible member forms a belly, wherein

the coaptation member has an outer cover surrounding a compressible inner filler member, wherein

the compressible inner filler member is an open cell foam that fills the space between the delivery catheter and the outer cover, and wherein

there are two types of open cell foam, with a majority being a first foam and a significantly stiffer second foam positioned in a thin region along the one diametric side between the delivery catheter and outer cover.

11. The system of claim 10, wherein the coaptation member has a generally cylindrical shape.

12. The system of claim 10, wherein the delivery catheter includes a series of perforations along a length that is located within the coaptation member to permit gas or fluid flow between pores in the filler member and an inner lumen of the catheter.

13. The system of claim 10, wherein the outer cover of the coaptation member is adhered around the delivery catheter so as to be closed on both ends and form a chamber only open to the perforations.

14. The system of claim 13, wherein both the outer cover and the delivery catheter are made of the same material.

15. The system of claim 10, wherein the ventricular anchor includes a plurality of circumferentially distributed and distally-directed sharp tines or barbs that pierce the tissue within a ventricle.

16. The system of claim 10, wherein the coaptation member has a diameter in its uncompressed state of about 10 mm, while the delivery catheter has an outer diameter of 2-3 mm.

17. The system of claim 10, further including at least one radiopaque marker on the delivery catheter or coaptation member that shows up as different shapes for different rotational orientations when viewed with a fluoroscope.

18. The system of claim 17, wherein the at least one radiopaque marker comprises a pair of C-shaped radiopaque markers bonded to the delivery catheter at different locations.