HEART VALVE DOCKING COILS AND SYSTEMS

• US 20180055628A1
• Filed: 08/21/2017
• Published: 03/01/2018
• Est. Priority Date: 08/26/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Patel, Darshin S., Manash, Boaz, Perlmutter, Khen, Leiba, Eyal, Rozen, Yoav, Sirimanne, Dinesh L.
• Granted Patent: US 10,463,479 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

Anchoring or docking devices configured to be positioned at a native valve of a human heart and to provide structural support for docking a prosthetic valve therein. The docking devices can have coiled structures that define an inner space in which the prosthetic valve can be held. The docking devices can have enlarged end regions with circular or non-circular shapes, for example, to facilitate implantation of the docking device or to better hold the docking device in position once deployed. The docking devices can be laser-cut tubes with locking wires to assist in better maintaining a shape of the docking device. The docking devices can include various features to promote friction, such as frictional cover layers. Such docking devices can have ends configured to more securely attach the cover layers to cores of the docking devices.

Claims

1. A docking device for docking a prosthetic valve at a native valve of a heart, the docking device comprising:

a coiled anchor that comprises;

a proximal tip and a distal tip;

at least one central turn having a first thickness and defining a central turn diameter;

an extension having a length extending from an upper end of the at least one central turn, the extension having a second thickness that is less than the first thickness;

an upper turn extending from an upper end of the transition portion, the upper turn having a third thickness that is greater than the second thickness; and

wherein the coiled anchor is configured to be implanted at the native valve with at least a portion of the at least one central turn of the coiled anchor positioned in a chamber of the heart and around valve leaflets of the native valve.

2. The device of claim 1, wherein the first thickness is at least 0.8 mm and the second thickness is between 0.4 to 0.8 mm.

3. The device of claim 1, wherein the coil has a rectangular cross-sectional shape, and the first thickness and second thickness are widths.

4. The device of claim 1, wherein the coil has a circular or elliptical cross-sectional shape, and the first thickness and second thickness are diameters.

5. The device of claim 1, wherein the extension length is between 5 to 100 mm, and creates a vertical separation between the at least one central turn and the upper turn.

6. The device of claim 1, wherein the at least one central turn diameter is between 20 to 30 mm.

7. The device of claim 1, wherein the first thickness and the second thickness are the same.

8. The device of claim 1, further comprising a lower turn extending from the at least one full or partial central turn, the lower turn having the first thickness and defining a lower turn diameter that is greater than the central turn diameter.

9. The device of claim 8, wherein the third thickness is the same as the first thickness and wherein the upper turn comprises a first diameter along a first axis and a second diameter along a second axis,

wherein the first axis diameter is greater than the central turn diameter, and wherein the second axis diameter is greater than the central turn diameter and less than the lower turn diameter.

10. The device of claim 8, wherein the lower turn diameter is between 30 to 75 mm.

11. The device of claim 9, wherein the first axis diameter is between 40 to 75 mm and the second axis diameter is larger than the diameter defined by the central turn.

12. The device of claim 9, wherein the first axis diameter is between 40 to 80 mm, and the second axis diameter is between 20 to 80 mm.

13. The device of claim 1, wherein the at least one central turn comprises between one-half to 5 turns, and the upper turn comprises between one-half to one turn.

14. The device of claim 8, wherein the lower turn comprises between 1 and 5 turns.

15. The device of claim 9, further comprising a cover layer comprised of a biocompatible material, wherein the cover layer surrounds the coiled anchor.

16. The device according to claim 15, wherein the cover layer comprises pores having a diameter of 30 to 100 microns.

17. The device of claim 15, wherein the cover layer extends at least along the portion of the coiled anchor that is configured to be in contact with a replacement valve.

18. The device of claim 15, wherein the coiled anchor further comprises securing holes near each of the proximal and distal tips.

19. The device of claim 18 wherein the cover layer is secured to the coiled anchor with sutures extending through the securing holes of the coiled anchor and through the cover layer.

20. The device of claim 15, further comprising a friction enhancing element that comprises a second cover layer surrounding and extending along at least a length of portion of the length of the cover layer, wherein the second cover layer is connected to the first cover layer by sutures and provides a coefficient of friction of at least 1.

21. The device of claim 20, wherein the second cover layer is a braided material.

22. The device of claim 20, wherein the second cover layer is a woven material.

23. The device of claim 20, wherein the second cover layer comprises pores having a diameter ranging in size from 30 to 100 microns.

24. The device of claim 17, further comprising at least one friction enhancing element that comprises a plurality of bulges on the surface of the coiled anchor or on the surface of the cover layer.

25. The device of claim 1, further comprising at least one friction enhancing element that comprises a plurality of lock and key cutouts in the outer surface of the coiled anchor.

26. The device of claim 25, wherein the lock cutouts are grooves formed in the outer surface of the coiled anchor, and the keys are protrusions extending outward from the coiled anchor, sized and shaped to fit into the lock cutouts.

27. The device of claim 1, further comprising a suture removeably threaded through a bore at the proximal tip and configured to be connected to a pusher device within a delivery catheter for retrieving the docking device.

28. The device of claim 27, wherein the suture is removeably threaded through the bore at a location along a length of the suture and then the suture ends are threaded through a space between the central point of the suture and the proximal tip of the coiled anchor.

29. The device of claim 1, further comprising a low friction cover layer, the low friction cover layer having a distal end and a proximal end, surrounding the coiled anchor and extending along a length of the coiled anchor, past the distal tip, and past the proximal tip, the low friction cover layer having a rounded or tapered tip at its distal end and at its proximal end.

30. The device of claim 1, wherein the distal tip of the coiled anchor is tapered slightly radially inward in a direction tangential to a circular shape formed by the central turn.

31. The device of claim 1, wherein the proximal tip of the coiled anchor is tapered slightly radially inwardly and is pointed in an upward direction.

32. A system for implanting the docking device of claim 1 at the native valve, comprising:

a delivery catheter;

a suture threaded through a bore in a proximal end of the delivery device; and

a pusher device disposable in the delivery catheter;

wherein the pusher device includes a central lumen;

wherein the suture is disposable in the central lumen such that pulling the suture and/or the pusher device proximally relative to the delivery catheter retracts the coiled anchor into the delivery catheter.

33. The system of claim 32, wherein the suture is threaded through the bore at a location along a length of the suture and then the suture ends are threaded through a space between the central point of the suture and the proximal end of the coiled anchor.

34-102. -102. (canceled)