Transcatheter valve with torsion spring fixation and related systems and methods

• US 8,652,204 B2
• Filed: 07/30/2010
• Issued: 02/18/2014
• 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): McEvoy, Thomas
• Assistant Examiner(s): ALEMAN, SARAH WEBB
• Application Number:
  US12/846,962
• Publication Number:
  US 20110245911A1
• Time in Patent Office: 1,299 Days
• Field of Search: 623/1.11, 623/1.13, 623/1.24, 623/1.26, 623/2.1, 623/2.17
• US Class Current: 623/2.17
• 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 including an inner lumen and having a first and a second end;

a plurality of support arms each having a first end and a second end, the first ends of the support arms being connected to the first end of the expandable stent, the second ends of the support arms comprising a loop; and

a unitary circular spring configured about a longitudinal axis of the expandable stent attached to the second ends of the support arms, wherein the unitary circular spring is rotatable about the longitudinal axis of the expandable stent through the loops of the support arms;

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.

2. The prosthetic valve of claim 1, further comprising a valvular element disposed in the inner lumen of the expandable stent.

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

4. The prosthetic valve of claim 1, wherein the support arms comprise a material that is more stiff than a material comprising the spring.

5. The prosthetic valve of claim 1, wherein the support arms limit the amount of radial expansion of the spring in order to result in a desired diametric configuration of the spring.

6. The prosthetic valve of claim 1, wherein the spring comprises a torsion spring.

7. The prosthetic valve of claim 1, wherein the expandable stent is sized to fit in a heart valve selected from a group consisting of an aortic valve, a mitral valve, a tricuspid valve, and a pulmonary valve.

8. The prosthetic valve of claim 1, wherein the spring and the expandable stent are compressed into a collapsed position for insertion into a sheath for delivery to the implantation position.

9. The prosthetic valve of claim 1, further comprising a second spring attached to the second end of the expandable stent.

10. The prosthetic valve of claim 1, wherein radial expansion of the spring causes axial translation of the stent toward the spring.

11. The prosthetic valve of claim 1, wherein the unitary circular spring is generally planar.

12. The prosthetic valve of claim 1, wherein the first ends of the support arms are rotatable about the first end of the expandable stent and wherein the second ends of the support arms are rotatable about the spring.

13. The prosthetic valve of claim 1, wherein the unitary circular spring comprises a plurality of coils wound about the longitudinal axis of the expandable stent.

14. A prosthetic valve delivery system, comprising:

a prosthetic valve, comprising;

an expandable stent including an inner lumen and having a first and a second end;

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

a plurality of support arms each having a first end and a second end, the first ends of the support arms being connected to the first end of the expandable stent, the second ends of the support arms comprising a loop; and

a unitary circular spring configured about a longitudinal axis of the expandable stent attached to the second ends of the support arms, wherein the unitary circular spring is rotatable about the longitudinal axis of the expandable stent through the loops of the support arms;

wherein the expandable stent and the spring can expand radially to a desired diametric configuration once deployed in order to anchor the prosthetic heart valve at an implantation position in a body lumen; and

a sheath comprising a distal end and a lumen in which the prosthetic valve is positioned prior to deployment of the prosthetic valve and out of which the prosthetic valve is deployed at the implantation position.

15. The prosthetic valve delivery system of claim 14, wherein the sheath is retractable in order to deploy the prosthetic valve.

16. The prosthetic valve delivery system of claim 14, wherein the unitary circular spring is generally planar.

17. The prosthetic valve delivery system of claim 14, wherein the first ends of the support arms are rotatable about the first end of the expandable stent and wherein the second ends of the support arms are rotatable about the spring.

18. The prosthetic valve delivery system of claim 14, wherein the unitary circular spring comprises a plurality of coils wound about the longitudinal axis of the expandable stent.

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

inserting a system into a body, the system comprising;

a prosthetic valve, comprising;

an expandable stent including an inner lumen and having a first and a second end;

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

a plurality of support arms each having a first end and a second end, the first ends of the support arms being connected to the first end of the expandable stent, the second ends of the support arms comprising a loop; and

unitary circular spring configured about a longitudinal axis of the expandable stent attached to the second ends of the support arms, wherein the unitary circular spring is rotatable about the longitudinal axis of the expandable stent through the loops of the support arms;

wherein the expandable stent and the spring can expand radially to a desired diametric configuration once deployed in order to anchor the prosthetic valve at an implantation position in a body lumen; and

a sheath comprising a distal end and a lumen in which the prosthetic valve is positioned prior to deployment of the prosthetic valve and out of which the prosthetic valve is deployed at the implantation position;

advancing the system to the implantation position; and

deploying the prosthetic valve to the desired diametric configuration to anchor the prosthetic valve at the implantation position.

20. The method of claim 19, wherein the sheath is retractable in order to deploy the prosthetic valve.

21. The method of claim 19, further comprising the step of pulling proximally on the system when the prosthetic valve is partially deployed.

22. The method of claim 19, further comprising the step of removing the remainder of the system and leaving the prosthetic valve, once deployed, in place.

23. The method of claim 19, wherein the unitary circular spring is generally planar.

24. The method of claim 19, wherein the first ends of the support arms are rotatable about the first end of the expandable stent and wherein the second ends of the support arms are rotatable about the spring.

25. The method of claim 19, wherein the unitary circular spring comprises a plurality of coils wound about the longitudinal axis of the expandable stent.