Heart valve docking devices and systems

• US 10,722,359 B2
• Filed: 02/22/2018
• Issued: 07/28/2020
• 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., Tran, Tri D., Chau, Jocelyn, Axelrod, Noa, Kiblitski, Zohar
• Primary Examiner(s): Ulsh, George J
• Application Number:
  US15/902,956
• Publication Number:
  US 20180177594A1
• Time in Patent Office: 887 Days
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

Docking devices for docking a prosthetic valve at a native valve of a heart can include a coiled docking anchor and a retrieval suture. The docking device and retrieval suture can be configured for improved retention and retrieval of the docking device after deployment. The docking devices can have an end portion with a central axis. The retrieval suture can be connected to the end portion such that a line of force applied by applying tension to the retrieval suture is substantially aligned with the central axis.

Claims

1. A system for implanting a docking device at a native valve, the system comprising:

a delivery catheter;

an elongated coiled docking device having a first end portion and a second end portion opposite the first end portion;

a pusher device having a central lumen, wherein the pusher device is disposed in the delivery catheter;

a retrieval line that extends through the central lumen of the delivery catheter and is coupled to the first end portion of the coiled docking device;

wherein the system is configured such that pulling the retrieval line pulls the first end portion of the coiled anchor against the pusher device; and

wherein the first end portion and retrieval line are configured and coupled such that a tension force from the pulling is biased to be substantially aligned with a central axis of the first end portion of the coiled docking device; and

wherein the coiled docking device comprises;

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

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

a proximal turn extending from a proximal end of the extension, the proximal turn having a third thickness that is greater than the second thickness.

2. The system of claim 1, wherein the first end portion is configured to align at least a lengthwise portion of the retrieval line along the central axis.

3. The system of claim 1, wherein the retrieval line extends through a central passage at a tip of the first end portion of the docking device, and wherein the central passage is aligned with the central axis.

4. The system of claim 1, wherein the docking device further comprises a spherical tip.

5. The system of claim 4, wherein the spherical tip receives the retrieval line through a passage that is aligned with central axis of the first end portion of the coiled docking device.

6. The system of claim 5, wherein the spherical proximal tip comprises an annular groove in a transition portion of the spherical proximal tip.

7. The system of claim 1, wherein a distal end of the pusher device is configured to engage a spherical surface at the first end portion of the coiled anchor.

8. The system of claim 1, wherein the first end portion of the docking device comprises tip with a loop, wherein the retrieval line is connected to the loop.

9. The system of claim 1, wherein the first end portion of the docking device comprises tip with a groove, wherein the retrieval suture is coupled to the first end portion in the groove.

10. The system of claim 1, wherein the coiled docking device comprises a distal turn on an opposite end of the coiled docking device from the first end portion, the distal turn having the first thickness and defining a diameter that is greater than the central turn diameter.

11. The system of claim 1, wherein the first end portion of the coiled docking device is at a proximal end of the proximal turn.

12. The system of claim 1, wherein the coiled docking device is configured to be implanted at the native valve with at least a portion of the coiled docking device positioned in a chamber of the heart and around valve leaflets of the native valve.

13. The system of claim 12, wherein the coiled docking device is configured to be implanted at the native mitral valve with at least a portion of the coiled docking device positioned in the left ventricle and around mitral valve leaflets of the native mitral valve.

14. The system of claim 12, wherein the coiled docking device is configured to be implanted at the native tricuspid valve with at least a portion of the coiled docking device positioned in the left ventricle and around tricuspid valve leaflets of the native tricuspid valve.

15. The system of claim 1, further comprising a cover layer comprising a biocompatible material, wherein the cover layer surrounds at least a portion of the coiled anchor.

16. The system of claim 15, wherein the cover layer is a low friction cover layer, having a distal end and a proximal end, surrounding the coiled docking device and extending along a length of the coiled docking device, past a distal tip of the coiled docking device, and past a proximal tip of the coiled docking device, the low friction cover layer tapering to a rounded tip at its distal end.

17. The system of claim 15, further comprising a friction enhancing element that comprises a second cover layer surrounding and extending along at least a portion of the cover layer, wherein the second cover layer provides a coefficient of friction of at least 1.

18. The system of claim 17, wherein the second cover layer is a braided material.

19. The system of claim 1, wherein the coiled docking device comprises:

a hollow tube having a proximal end and a distal end;

a plurality of cuts through portions of the tube;

a wire having a length, a proximal end, and a distal end;

wherein the distal end of the wire is secured to a distal end of the hollow tube and the proximal end of the wire is secured to a proximal end of the hollow tube;

wherein the length of the wire extends through the hollow tube and applies a radially inward tension on the hollow tube.

20. The system of claim 19, wherein the cuts have a pattern and shape that incorporates both longitudinal and transverse cuts forming teeth and grooves in the hollow tube.

21. The system of claim 1, wherein the coiled docking device includes a core, and a distal end of the core has a rectangular cross-section and a distal ring-shaped tip, wherein the distal end of the core is at the second end portion of the elongated coiled docking device.

22. The system of claim 1, wherein the coiled docking device includes a core, and a distal end of the core has a ball-shaped tip, wherein the distal end of the core is at the second end portion of the elongated coiled docking device.