Systems and methods for treating lumenal valves

• US 8,894,704 B2
• Filed: 04/23/2013
• Issued: 11/25/2014
• Est. Priority Date: 10/06/2009
• Status: Active Grant

• Current Assignee: Reniva Incorporated
• Original Assignee: Adam Groothuis, Adrian Ebner, Elazer Edelman, Peter Markham
• Inventors: Groothuis, Adam, Ebner, Adrian, Markham, Peter, Edelman, Elazer
• Primary Examiner(s): Snow, Bruce E
• Assistant Examiner(s): DUKERT, BRIAN AINSLEY
• Application Number:
  US13/868,226
• Publication Number:
  US 20130310924A1
• Time in Patent Office: 581 Days
• Field of Search: 623/1.12, 623/2.1, 623/2.11
• US Class Current: 623/2.11
• 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 compartment therebetween for receiving a valve prosthesis;

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

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

e) a valve prosthesis for replacing a portion of a lumenal valve, the valve prosthesis including a leaflet attached to a deformable structural circumferential portion mounted in the compartment, the deformable structural circumferential portion of the valve prosthesis having a curved shape when fully deployed and having a first circumferential end and a second circumferential end separated by a gap that is spanned at least in part by the leaflet, the deformable structural circumferential portion having a proximal portion near the first circumferential end attached to the first linkage and a distal portion near the second circumferential end attached to the second linkage, wherein;

i) the deployable valve prosthesis can be arranged into a first configuration wherein the deformable structural circumferential portion is generally straight and in an elongate orientation that is generally parallel to a longitudinal axis of the catheter when the valve prosthesis is disposed within the compartment between the elongate body and retractable sheath; and

ii) the deployable valve prosthesis can be deployed from the first configuration into a second configuration wherein the deformable structural circumferential portion is curved and disposed in a plane generally perpendicular to the longitudinal axis of the catheter after the sheath is withdrawn.

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 configured to deploy the valve prosthesis when the sheath is in a retracted position when the second linkage is moved in a proximal direction with respect to the elongate body and when the first linkage is moved in a distal direction with respect to the elongate body.

5. The catheter of claim 4, wherein the valve prosthesis is configured to be in a generally longitudinal orientation prior to deployment, and is configured to become reoriented into a second, generally arcuate orientation when the second linkage is moved in a proximal direction with respect to the elongate body and when the first linkage is moved in a distal direction with respect to the elongate body.

6. The catheter of claim 1, wherein the sheath and elongate body cooperate to define a second compartment therebetween, the second 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 region attached to the third linkage and a distal region 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 configured to deploy the second valve prosthesis when the sheath is in a retracted position when the fourth linkage is moved in a proximal direction with respect to the elongate body and when the third linkage is moved in a distal direction with respect to the elongate body.

11. The catheter of claim 10, wherein the second valve prosthesis is configured to be in a generally longitudinal orientation prior to deployment, and is configured to become reoriented into a second, generally arcuate orientation when the fourth linkage is moved in a proximal direction with respect to the elongate body and when the third linkage is moved in a distal direction with respect to the elongate body.

12. The catheter of claim 1, wherein the first and second linkages include a portion made from a hypotube.

13. The catheter of claim 1, wherein the first and second linkages are solid members.

14. The catheter of claim 13, wherein the first and second linkages include carbon fiber reinforced material.

15. The catheter of claim 1, wherein the first and second linkages include a nickel-titanium alloy.

16. The catheter of claim 1, wherein the elongate body is an inner member defining a plurality of lumens along its length.

17. The catheter of claim 16, wherein one of the lumens in the inner member includes a pull wire disposed therein.

18. The catheter of claim 16, wherein one of the lumens in the inner member includes a guide wire disposed therein.

19. The catheter of claim 1, wherein the deformable structural circumferential portion includes shape memory material.

20. The catheter of claim 1, wherein the second linkage is disposed alongside the prosthesis in the compartment before the sheath is withdrawn.

21. The catheter of claim 1, wherein the first and second linkages are splayed apart by expansion of the deployable valve prosthesis when the deployable valve prosthesis is in the second configuration, and wherein the first and second linkages can be manipulated to position the valve prosthesis while in the second configuration.