Prosthetic cardiac valve devices, systems, and methods

Patent metadata

Field	Value
Publication number	US-10912644-B2
Application number	US-201916594946-A
Country	US
Kind code	B2
Filing date	Oct 7, 2019
Priority date	Oct 5, 2018
Publication date	Feb 9, 2021
Grant date	Feb 9, 2021

Abstract

Systems, devices, and methods for treating a diseased native valve in a patient, the system comprising a compressible and expandable frame structure and an anchor. The anchor comprises a wire having a free end and is configured to be fully advanced from an atrial side of a native valve in a patient into a ventricle of the heart and anchor the frame structure to the native valve when the frame structure is in the expanded configuration adjacent the native valve.

First claim

What is claimed is:

1. A method for treating a diseased native valve in a patient, the method comprising:
advancing a distal end of a delivery device to a first side of a native valve, wherein the distal end of the delivery device is detachably coupled to an anchor and a frame structure;
deploying the anchor from a delivery configuration to a deployed configuration on the first side of the native valve;
advancing the anchor in the deployed configuration from the first side of the native valve to a second side of the native valve such that the anchor is located only on the second side of the native valve;
rotating a free end of the anchor in the deployed configuration around one or more structures on the second side of the native valve;
releasing the anchor from the distal end of the delivery device;
expanding the frame structure within the native valve from a compressed configuration to an expanded configuration;
releasing the frame structure from the distal end of the delivery device; and
retracting the delivery device from the native valve.

2. The method of claim 1 , further comprising steering the distal end of the delivery device such that the distal end of the delivery device points towards the first side of the native valve.

3. The method of claim 1 , wherein advancing the anchor comprises pushing the anchor through the native valve.

4. The method of claim 1 , wherein advancing the anchor comprises rotating the anchor through the native valve.

5. The method of claim 1 , wherein the frame structure comprises first and second opposite ends and wherein expanding the frame structure comprises expanding the frame structure such that the first end extends above the first side of the native valve and the second end extends below the second side of the native valve.

6. The method of claim 1 , wherein expanding the frame structure comprises expanding at least a portion the frame structure within at least a portion of the deployed anchor to anchor the frame structure to the native valve.

7. The method of claim 1 , wherein expanding the frame structure and releasing the frame structure occur simultaneously.

8. The method of claim 1 , wherein the frame structure is balloon-expandable and wherein expanding the frame structure comprises inflating a balloon disposed within the frame structure, wherein inflation of the balloon causes expansion of the frame structure.

9. The method of claim 1 , wherein the frame structure is self-expanding and wherein expanding the frame structure comprises releasing the frame structure from radial constriction by the delivery device.

10. The method of claim 1 , wherein the one or more structures comprise one or more valve leaflets of the native valve.

11. The method of claim 1 , wherein the one or more structures comprise one or more chordae of the left ventricle.

12. The method of claim 1 , wherein the free end is disposed radially outward from a main body of the anchor in the deployed configuration in order to facilitate rotation of the free end around the one or more structures.

13. The method of claim 1 , wherein the free end comprises an atraumatic tip.

14. The method of claim 1 , wherein the free end comprises a ball tip.

15. The method of claim 1 , wherein the free end is configured for piercing tissue.

16. The method of claim 1 , wherein the frame structure comprises a valve segment therewithin comprising a biocompatible one-way valve.

17. The method of claim 1 , wherein the native valve is in a heart of a patient.

18. The method of claim 17 , further comprising transseptally inserting the distal end of the delivery device into a left atrium of the heart.

19. The method of claim 17 , wherein the native valve comprises a mitral valve, the first side of the native valve comprises a left atrium, and the second side of the native valve comprises a left ventricle.

20. The method of claim 17 , wherein the native valve comprises an aortic valve, the first side of the native valve comprises a left ventricle, and the second side of the native valve comprises an aorta.

21. The method of claim 17 , wherein the native valve comprises a tricuspid valve, the first side of the native valve comprises a right atrium, and the second side of the native valve comprises a right ventricle.

22. The method of claim 1 , wherein the anchor comprises a curved wire.

23. The method of claim 22 , wherein the curved wire comprises a helical wire.

24. The method of claim 23 , wherein the anchor comprises a first portion comprising the helical wire and another portion.

25. The method of claim 23 , wherein the helical wire has a generally tubular shape.

26. The method of claim 25 , wherein the free end of the helical wire extends radially outward from the tubular shape.

27. The method of claim 23 , wherein the helical wire has a generally frustoconical shape.

28. The method of claim 27 , wherein the free end of the helical wire extends radially outward from the frustoconical shape.

29. The method of claim 23 , wherein the helical wire has a generally cylindrical shape.

30. The method of claim 29 , wherein the free end of the helical wire extends radially outward from the cylindrical shape.

Assignees

• Shifamed Holdings Llc

Inventors

• Argento Claudio
• Backus Andrew
• Yang Alice

Classifications

• A61F2250/0063

  Nested prosthetic parts · CPC title

• A61F2220/0008

  Fixation appliances for connecting prostheses to the body · CPC title

• A61F2210/0014

  using shape memory or superelastic materials, e.g. nitinol · CPC title

• A61F2/2427

  Devices for manipulating or deploying heart valves during implantation · CPC title

• A61F2/2466

  Delivery devices therefor · CPC title