Transcatheter valve with torsion spring fixation and related systems and methods

• US 9,925,044 B2
• Filed: 01/15/2014
• Issued: 03/27/2018
• 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 WEBB
• Application Number:
  US14/156,076
• Publication Number:
  US 20140180401A1
• Time in Patent Office: 1,532 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:

an expandable stent defining a first end, a second end, and an inner lumen, and having a longitudinal axis;

a valvular element disposed in the inner lumen of the expandable stent;

an expandable positioning element connected to the first end of the expandable stent wherein the expandable positioning element comprises a wire that forms a circular loop about the longitudinal axis of the expandable stent to be concentric therewith,

wherein the circumference of the wire loop of the expandable positioning element is greater than a circumference of the expandable stent when the prosthetic valve is in an expanded configuration; and

a connecting element pivotally attached to the first end of the expandable stent, the connecting element being a separate element from each of the expandable stent and the expandable positioning element, the connecting element also attached, by a loop of the connecting element, to the expandable positioning element such that the expandable positioning element is configured to laterally rotate outward from the first end of the expandable stent during expansion of the expandable positioning element, wherein the connecting element is capable of extending generally perpendicular to the longitudinal axis of the expandable stent when the expandable positioning element is in an expanded configuration, and wherein the expandable positioning element is configured to assist in the proper placement of the prosthetic valve within a body.

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

3. The prosthetic valve of claim 1, wherein the second end of the expandable stent is flared outward relative to the longitudinal axis of the expandable stent.

4. The prosthetic valve of claim 1, wherein the expandable positioning element comprises a shape memory alloy.

5. The prosthetic valve of claim 1, wherein the expandable positioning element comprises a torsion spring.

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. A prosthetic valve comprising:

an expandable stent defining a first end, a second end, and an inner lumen, and having a longitudinal axis;

an expandable spring connected to the first end of the expandable stent wherein the expandable spring is formed from a coil that is wound about the longitudinal axis of the expandable stent to be concentric therewith, wherein the circumference of the coil of the expandable spring is greater than a circumference of the expandable stent when the prosthetic valve is in an expanded configuration; and

a plurality of support arms connecting the expandable spring to the first end of the expandable stent, wherein each of the plurality of support arms is capable of extending generally perpendicular to the longitudinal axis of the expandable stent when the expandable spring is in an expanded configuration.

10. The prosthetic valve of claim 9, wherein the expandable spring is circular.

11. The prosthetic valve of claim 9, wherein the coil is a plurality of coils and wherein each coil of the plurality of coils is wound about the longitudinal axis of the expandable stent to be concentric therewith.

12. The prosthetic valve of claim 11, wherein the coils contact each other.

13. The prosthetic valve of claim 11, wherein the coils are spaced from each other.

14. The prosthetic valve of claim 9, further comprising a second expandable spring connected to the second end of the expandable stent.

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

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

an expandable stent having a first end, a second end, an inner lumen, and a longitudinal axis,

a valvular element disposed in the inner lumen of the expandable stent; and

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

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

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

16. The method of claim 15, wherein inserting the delivery system into the body lumen comprises transapically inserting the delivery system into a heart.

17. The method of claim 15, wherein proximally pulling the prosthetic valve engages the expandable annular member with a heart wall in a left atrium adjacent a mitral valve annulus.

18. The method of claim 15, wherein the expandable annular member comprises a wire.

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

20. The method of claim 15, wherein the step of at least partially deploying the prosthetic valve includes viewing the prosthetic valve using image guidance.

21. The method of claim 20, wherein image guidance may be selected from the group consisting of fluoroscopy, ultrasonic means, magnetic resonance, X-ray, and computer tomography.

22. 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 a first end, a second end, 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 pivotally connected by a connecting element to the first end of the first expandable annular portion, the connecting element being a separate element from each of the first expandable annular portion and the second expandable annular portion and having a loop for pivotally connecting with the second 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 second expandable annular portion pivots outwardly relative to the first expandable annular portion to permit expansion of the second expandable annular portion, wherein 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;

proximally pulling the prosthetic valve to engage the second expandable annular portion with a heart wall in a left atrium adjacent a mitral valve annulus; and

fully deploying the prosthetic valve to engage the first expandable annular portion with the mitral valve annulus.