Transcatheter valve with torsion spring fixation and related systems and methods

• US 10,716,665 B2
• Filed: 02/23/2018
• Issued: 07/21/2020
• Est. Priority Date: 04/01/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Quill, Jason, Clague, Cynthia T., Rothstein, Paul T.
• Primary Examiner(s): Aleman, Sarah W
• Application Number:
  US15/903,642
• Publication Number:
  US 20180185142A1
• Time in Patent Office: 879 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped

Abstract

Described is a prosthetic valve, comprising: an expandable stent including an inner lumen and having a first and a second end; and a spring attached to the first end of the expandable stent; wherein the expandable stent and the spring can expand radially to a desired diametric configuration in order to anchor the prosthetic valve at an implantation position in a body lumen. Related systems and methods.

Claims

1. A prosthetic valve, comprising:

a first expandable annular member defining an inner lumen, and having a longitudinal axis;

a valvular element disposed in the inner lumen of the first expandable annular member;

a second expandable annular member having a circumference greater than a circumference of the first expandable annular member when the prosthetic valve is in an expanded configuration; and

a connecting element connecting the first expandable annular member to the second expandable annular member, the connecting element being a separate element from each of the first and second expandable annular members, the connecting element having a loop or eyelet for connecting with the first expandable annular member, the connecting element configured to allow movement between the first and second expandable annular members such that the connecting element is configured to laterally rotate outward from the first expandable annular member during expansion of the second expandable annular member wherein at least a portion of the connecting element is capable of extending generally perpendicular to the longitudinal axis of the first expandable annular member when the second expandable annular member is in an expanded configuration, and wherein the second expanded annular member is configured to assist in the proper placement of the prosthetic valve within a body.

2. The prosthetic valve of claim 1, wherein the second expandable annular member comprises a wire that forms an expandable circular loop.

3. The prosthetic valve of claim 2, wherein the wire comprises a shape memory alloy.

4. The prosthetic valve of claim 2, wherein the wire forms a torsion spring.

5. The prosthetic valve of claim 1, wherein the valvular element comprises at least one leaflet.

6. The prosthetic valve of claim 1, wherein the prosthetic valve is a prosthetic heart valve.

7. The prosthetic valve of claim 6, wherein the prosthetic heart valve is a prosthetic mitral valve.

8. The prosthetic valve of claim 6, wherein the prosthetic heart valve is a prosthetic aortic valve.

9. The prosthetic valve of claim 1, wherein the second expandable annular member comprises a radiopaque material.

10. The prosthetic valve of claim 1, wherein the connecting element has a second loop or eyelet for connecting with the second expandable annular member.

11. A method of implanting a prosthetic valve, comprising:

inserting a delivery system with a prosthetic valve into a body lumen, the prosthetic valve comprising

a first expandable annular member having an inner lumen, and a longitudinal axis,

a valvular element disposed in the inner lumen of the first expandable annular member, and

a second expandable annular member connected by a connecting element to the first expandable annular member, the connecting element being a separate element from each of the first and second expandable annular members, the connecting element having a loop or eyelet for connecting with the first expandable annular member, wherein the circumference of the second expandable annular member is greater than a circumference of the first expandable annular member when the prosthetic valve is in an expanded configuration;

at least partially deploying the prosthetic valve at an implantation location such that the connecting element pivots outwardly relative to the first expandable annular member to permit expansion of the second expandable annular member, wherein at least a portion of the connecting element is capable of extending generally perpendicular to the longitudinal axis of the first expandable annular member when the second expandable annular member is in an expanded configuration; and

proximally pulling the prosthetic valve to engage at least a portion of the second expandable annular member with a wall of the body lumen.

12. The method of claim 11, wherein the step of inserting the delivery system into the body lumen comprises transapically inserting the delivery system into a heart.

13. The method of claim 11, wherein the step of proximally pulling the prosthetic valve engages at least a portion of the second expandable annular member with a heart wall in a left atrium adjacent a mitral valve annulus.

14. The method of claim 11, wherein the second expandable annular member comprises a wire.

15. The method of claim 11, wherein the second expandable annular member comprises a radiopaque material.

16. The method of claim 11, wherein the step of at least partially deploying the prosthetic valve includes viewing the prosthetic valve using image guidance.

17. The method of claim 16, wherein the image guidance may be selected from the group consisting of fluoroscopy, ultrasonic means, magnetic resonance, X-ray, and computer tomography.

18. The method of claim 11, wherein the connecting element has a second loop or eyelet for connecting with the second expandable annular member.

19. A method of implanting a prosthetic valve, comprising:

inserting a delivery system with a prosthetic valve into a body lumen, the prosthetic valve comprising

a first expandable annular portion having an inner lumen, and a longitudinal axis,

a valvular element disposed in the inner lumen of the first expandable annular portion, and

a second expandable annular portion rotatably connected to the first expandable annular portion by a connecting element, the connecting element being a separate element from each of the first and second expandable annular portions, the connecting element having a loop or eyelet for connecting with the first expandable annular portion, wherein the circumference of the second expandable annular portion is greater than a circumference of the first expandable annular portion when the prosthetic valve is in an expanded configuration;

at least partially deploying the prosthetic valve at an implantation location such that the connecting element rotates outwardly relative to the first expandable annular portion to permit expansion of the second expandable annular portion, wherein at least a portion of the connecting element is capable of extending generally perpendicular to the longitudinal axis of the first expandable annular portion when the second expandable annular member is in the expanded configuration; and

proximally pulling the prosthetic valve to engage at least a portion of the second expandable annular portion with a heart wall in a left atrium adjacent a mitral valve annulus.

20. The method of claim 19, wherein the second expandable annular portion comprises a wire.