IP Library Granted Patent US 11,344,407
Granted Patent B2
US 11,344,407 · App. 16/673,660 · Granted May 31, 2022

Heart valve docking coils and systems

Inventors: Darshin S. Patel (San Juan Capistrano, CA); Boaz Manash (Givat Ada, IL); Khen Perlmutter (Binyamina, IL); Yoav Rozen (Binyamina, IL); Dinesh L. Sirimanne (Irvine, CA); Zohar Kiblitski (Haifa, IL); Noa Axelrod (Netanya, IL)
Assignee: Edwards Lifesciences Corporation
A61F2/2409A61F2/2412A61F2/2418A61F2/2427A61F2/2436A61F2/2466A61B2017/00243A61B2017/0649A61F2230/0008A61F2230/0091A61F2250/0036A61F2250/0039
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Quick Facts
Patent No.
US 11,344,407
App. No.
16/673,660
Granted
May 31, 2022
Kind
B2
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 (27)

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:

at least one central turn defining a central turn diameter;

a lower turn extending from the at least one central turn defining a diameter that is greater than the central turn diameter;

an upper turn connected to the at least one central turn, the upper turn being shaped to have 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; 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 according to claim 1 , wherein the at least one central turn defines a diameter between 20 to 30 mm.

3. The device of claim 1 , wherein the lower turn defines a diameter between 30 to 75 mm.

4. The device of claim 1 , wherein the first axis diameter is between 40 to 80 mm, and the second axis diameter is between 20 to 80 mm.

5. The device of claim 1 , wherein the first axis diameter is 40 to 75 mm, and the second axis diameter is larger than the diameter defined by the at least one central turn.

6. The device of claim 1 , wherein the coiled anchor comprises a coiled wire having a rectangular cross-sectional shape with a thickness of at least 0.8 mm.

7. The device of claim 1 , wherein the coiled anchor comprises a coil that has a circular or elliptical cross-sectional shape with a thickness of at least 0.8 mm.

8. The device of claim 1 , wherein the at least one central turn comprises between one half rotation turn to five full-rotation turns, the upper turn comprises between one half turn to one turn, and the lower turn comprises between one half turn to five turns.

9. The device of claim 1 , further comprising a suture removeably threaded through a bore in the coiled anchor and configured to be connected to a pusher device within a delivery catheter to provide a means for retrieving the docking device.

10. The device of claim 9 , 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 end of the coiled anchor.

11. The device of claim 1 , further comprising a 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 a distal tip of the coiled anchor, and past a proximal tip of the coiled anchor, the low friction cover layer tapering to a rounded tip at its distal end and at its proximal end.

12. The device of claim 11 , 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.

13. The device of claim 11 , wherein the proximal tip of the coiled anchor is tapered slightly radially inwardly and is pointed in an upward direction.

14. The device of claim 1 , wherein the coiled anchor further comprises an extension having a length extending from an upper end of the central turn comprising a second thickness that is less than a first thickness of the upper turn.

15. The device of claim 14 , wherein at least a portion of the extension extends vertically at an angle of between 70-110 degrees relative to the at least one central turn.

16. 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 device; and

a pusher device, wherein the pusher device includes a central lumen;

wherein the pusher device is disposable in the delivery catheter and 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.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 25, 2020
From: PATEL, DARSHIN S.; MANASH, BOAZ; PERLMUTTER, KHEN; ROZEN, YOAV; SIRIMANNE, DINESH L.; KIBLITSKI, ZOHAR; AXELROD, NOA
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 052229/0112 →
Continuity (4)
Continuation 15682287 · Aug 21, 2017
Provisional Application 62395940 · Sep 16, 2016
Provisional Application 62380117 · Aug 26, 2016
Related Publication 20200060811A1 · Feb 27, 2020