Heart valve docking system

• US 10,687,938 B2
• Filed: 08/23/2017
• Issued: 06/23/2020
• Est. Priority Date: 08/26/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Patel, Darshin S., Altman, Hernan, Manash, Boaz, Levi, Tamir S., Sirimanne, Dinesh L.
• Primary Examiner(s): Shi, Katherine M
• Assistant Examiner(s): Mendoza, Michael G
• Application Number:
  US15/684,836
• Publication Number:
  US 20180055630A1
• Time in Patent Office: 1,035 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

Docking devices can be configured to be positioned at a native valve of a human heart to provide structural support for docking a prosthetic valve. The docking devices generally have coiled structures that define an inner space in which the prosthetic valve can be held. Some docking devices can be adjusted from a first wider configuration which facilitates easier advancement of the docking device around the valve anatomy, to a second narrower configuration after the docking device has been delivered to more securely hold the prosthetic valve. The docking device may also be better held in position at the native valve after adjustment to the narrower configuration. Some docking devices include a stabilization segment or double coil configuration, where a main coil region is configured to securely hold a prosthetic valve, while a stabilization coil region is configured to more stably hold the docking device at the native valve.

Claims

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

a flexible body comprising an elongate tubular structure, a first lumen extending at least partially through the flexible body, and a second lumen extending at least partially through the flexible body;

a first coil more rigid than the flexible body, comprising a first plurality of circular turns, the first coil configured to fit within the first lumen, and the first plurality of circular turns comprising a first diameter in a relaxed state;

a second coil more rigid than the flexible body, comprising a second plurality of circular turns, the second coil configured to fit within the second lumen, and the second plurality of circular turns comprising a second diameter in a relaxed state that is less than the first diameter;

wherein the docking device has a first configuration with a third diameter when the first coil is positioned within the first lumen;

wherein the docking device has a second configuration with a fourth diameter when the second coil is positioned within the second lumen, and wherein the fourth diameter is less than the first diameter and the third diameter.

2. The device of claim 1 wherein the third diameter is greater than or equal to the first diameter.

3. The device according to claim 1, wherein the fourth diameter is greater than the second diameter.

4. The device according to claim 1, wherein the fourth diameter is equal to the second diameter.

5. The device according to claim 1, wherein:

the first diameter is between 20 to 40 mm; and

the second diameter is between 15 to 30 mm.

6. The device according to claim 1, wherein the first diameter is between 2 to 10 times greater than the second diameter.

7. The device according to claim 1, wherein the first coil further comprises an upper turn extending in a proximal direction from the plurality of turns, wherein the upper turn of the first coil is configured as a stabilization turn to help prevent migration of the docking device, the upper turn of the first coil defining an upper turn diameter greater than the first diameter.

8. The device according to claim 1, wherein a proximal end of the first lumen is open.

9. The device according to claim 1, wherein a proximal end of the second lumen is open.

10. The device according to claim 1, further comprising a high-friction cover on a portion of the flexible body configured such that slippage of the docking device relative to the native leaflets is inhibited when implanted.

11. The device according to claim 1, further comprising a covering having a large amount of surface area to promote tissue ingrowth.

12. A system for replacing a heart valve, the system comprising:

a replacement valve; and

a docking device, wherein the docking device comprises;

a flexible body comprising an elongate tubular, a first lumen extending at least partially through the flexible body, and a second lumen extending at least partially through the flexible body;

a first coil more rigid than the flexible body, comprising a first plurality of circular turns, the first coil configured to fit within the first lumen, and the first plurality of circular turns comprising a first diameter in a relaxed state;

a second coil more rigid than the flexible body, comprising a second plurality of circular turns, the second coil configured to fit within the second lumen, and the second plurality of circular turns comprising a second diameter in a relaxed state that is less than the first diameter;

wherein the docking device has a first configuration with a third diameter when the first coil is positioned inside the first lumen;

wherein the docking device has a second configuration defining an inner space having a fourth diameter when the second coil is positioned inside the second lumen, and wherein the fourth diameter is less than the first diameter and the third diameter;

wherein the replacement valve comprises an expandable frame and a plurality of leaflets and is configured to be inserted in the inner space and expanded, the expandable frame defining an expanded outer diameter when in an expanded configuration; and

wherein the replacement valve in the expanded configuration is configured to apply an outward pressure to the docking device sufficient to maintain a stable position of the replacement valve within the inner space of the docking device.

13. The system of claim 12, wherein:

the first diameter is between 20 to 40 mm;

the second diameter is between 15 to 30 mm.

14. The system according to claim 12, wherein

the first coil further comprises an upper turn extending in a proximal direction from the plurality of turns, wherein the upper turn of the first coil is configured as a stabilization turn to help prevent migration of the docking device, the upper turn of the first coil defining an upper turn diameter greater than the first diameter.

15. The system of claim 14, wherein the upper turn is between 40 to 100 mm.

16. The system according to claim 12, wherein the flexible body is comprised of a co-extruded thermoplastic material.