SYSTEMS AND METHODS FOR TREATING LUMENAL VALVES

• US 20110112630A1
• Filed: 10/06/2010
• Published: 05/12/2011
• Est. Priority Date: 10/06/2009
• Status: Active Grant

• Current Assignee: Reniva Incorporated
• Original Assignee: Adam Groothuis, Adrian Ebner, Elazer R. Edelman, Peter Markham
• Inventors: Markham, Peter, Ebner, Adrian, Groothuis, Adam, Edelman, Elazer R.
• Granted Patent: US 10,022,222 B2
• Time in Patent Office: Days
• US Class Current: 623/2.1
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2475 Venous valves

Abstract

The present embodiments relate to systems and methods for treating lumenal valves. Particularly, and in accordance with one aspect, the present disclosure is directed to methods and systems for partial or complete replacement of lumenal valves. An exemplary catheter in accordance with the disclosure includes an elongate body having a proximal end and a distal end, and a retractable sheath mounted on the elongate body proximate the distal end. The sheath and elongate body cooperating to define a first annularly-shaped compartment between the body and sheath. The catheter further includes a valve prosthesis mounted in the compartment, the prosthesis having proximal and distal ends connected to a means for deploying the valve prosthesis from the catheter.

Claims

1. A catheter comprising:

a) an elongate body having a proximal end and a distal end;

b) a retractable sheath mounted on the elongate body proximate the distal end, the sheath and elongate body cooperating to define a first annularly-shaped compartment therebetween;

c) a first linkage extending from a proximal region of the compartment toward the proximal end of the catheter;

d) a second linkage extending from a distal region of the compartment toward the proximal end of the catheter; and

e) a valve prosthesis mounted in the compartment, the prosthesis having a proximal end attached to the first linkage and a distal end attached to the second linkage.

2. The catheter of claim 1, further comprising a guide for directing the path of travel of the first linkage and second linkage to facilitate deployment of the valve prosthesis.

3. The catheter of claim 1, wherein the sheath is adapted and configured to be retracted along a longitudinal axis of the catheter to expose the valve prosthesis.

4. The catheter of claim 1, wherein the first linkage and second linkage are adapted and configured to deploy the valve prosthesis when the sheath is in a retracted position by advancing the second linkage in a proximal direction and by advancing the first linkage in a distal direction.

5. The catheter of claim 4, wherein the valve prosthesis is in a generally longitudinal orientation prior to deployment, and is reoriented into a second, generally arcuate orientation when the second linkage is advanced in a proximal direction and when the first linkage is advanced in a distal direction.

6. The catheter of claim 1, wherein the sheath and elongate body cooperate to define a second annularly-shaped compartment therebetween, the second annularly-shaped compartment being displaced along a longitudinal axis of the catheter from the first compartment.

7. The catheter of claim 6, wherein the catheter further comprises:

a) a third linkage extending from a proximal region of the second compartment toward the proximal end of the catheter;

b) a fourth linkage extending from a distal region of the second compartment toward the proximal end of the catheter; and

c) a second valve prosthesis mounted in the second compartment, the second prosthesis having a proximal end attached to the third linkage and a distal end attached to the fourth linkage.

8. The catheter of claim 7, further comprising a second guide for directing the path of travel of the third linkage and fourth linkage to facilitate deployment of the second valve prosthesis.

9. The catheter of claim 7, wherein the sheath is adapted and configured to be retracted along the longitudinal axis of the catheter to expose the second valve prosthesis.

10. The catheter of claim 7, wherein the third linkage and fourth linkage are adapted and configured to deploy the second valve prosthesis when the sheath is in a retracted position by advancing the fourth linkage in a proximal direction and by advancing the third linkage in a distal direction.

11. The catheter of claim 10, wherein the second valve prosthesis is in a generally longitudinal orientation prior to deployment, and is reoriented into a second, generally arcuate orientation when the fourth linkage is advanced in a proximal direction and when the third linkage is advanced in a distal direction.

12. A deployable valve prosthesis for replacing at least a portion of a lumenal valve, the valve prosthesis including a deformable body, wherein:

a) the deformable body may be arranged into a first generally longitudinal orientation suitable for mounting underneath the retractable sheath of a catheter; and

wherein

b) the deformable body may be rearranged into a second orientation that is generally arcuate.

13. The deployable valve prosthesis of claim 12, wherein the deformable body includes shape memory material.

14. The deployable valve prosthesis of claim 13, wherein the shape memory material includes a nickel-titanium alloy.

15. The deployable valve prosthesis of claim 12, wherein the deformable body is constructed at least in part of a scaffolding material.

16. The deployable valve prosthesis of claim 15, wherein the deformable body has a generally serpentine shape.

17. The deployable valve prosthesis of claim 12, wherein the valve prosthesis further includes at least one deployable valve leaflet attached to the deformable body, wherein the valve leaflet is fully deployed upon implantation of the valve prosthesis.

18. The deployable valve prosthesis of claim 12, wherein the prosthesis includes biological material.

19. The deployable valve prosthesis of claim 18, wherein the biological material includes material obtained from a cadaver.

20. The deployable valve prosthesis of claim 18, wherein the biological material includes cellular content.

21. A method for delivering a valve prosthesis, comprising:

a) advancing a distal portion of a catheter to a target location proximate a valve within a patient'"'"'s lumenal system;

b) withdrawing a sheath on the catheter to expose a valve prosthesis, the valve being in a generally longitudinal orientation prior to withdrawing the sheath;

c) deforming the valve prosthesis from the generally longitudinal orientation into a second, generally arcuate orientation.

22. The method of claim 21, wherein the valve prosthesis is deformed from the generally longitudinal orientation into the generally arcuate orientation by drawing a first end of the valve prosthesis toward a second end of the valve prosthesis.

23. The method of claim 22, wherein the valve prosthesis lies in a plane that is generally parallel to the longitudinal axis of the catheter when the first end of the valve prosthesis is drawn toward a second end of the valve prosthesis.

24. The method of claim 21, further comprising rotating the valve prosthesis out of the plane generally parallel to the longitudinal axis of the catheter into a plane that is generally perpendicular to the longitudinal axis of the catheter.

25. The method of claim 22, further comprising spreading the valve prosthesis and aligning it with a portion of the annulus of the valve of a patient.

26. The method of claim 23, wherein the existing valve leaflet of the patient is pushed against the valve annulus or vessel wall when the valve prosthesis is aligned.

27. The method of claim 24, further comprising attaching the valve prosthesis to the valve annulus of the patient.

28. The method of claim 25, wherein the installed valve prosthesis occupies about half of the circumference of the valve annulus when installed.

29. The method of claim 26, further comprising installing a second valve prosthesis adjacent the first valve prosthesis, wherein the second valve prosthesis substantially occupies the portion of the circumference of the valve annulus not occupied by the previously installed valve prosthesis.