Systems and methods for treating lumenal valves

• US 10,022,222 B2
• Filed: 10/06/2010
• Issued: 07/17/2018
• 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: Groothuis, Adam, Ebner, Adrian, Markham, Peter, Edelman, Elazer R.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): WOLF, MEGAN YARNALL
• Application Number:
  US12/899,231
• Publication Number:
  US 20110112630A1
• Time in Patent Office: 2,841 Days
• Field of Search: 623 21- 219, 623 236- 238
• 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 deployable valve prosthesis for replacing a portion of a native lumenal valve, the native lumenal valve defining a native valve annulus and a plurality of native leaflets, the prosthesis comprising:

a) a self-deployable elongate deformable structural member having a first free end, a second free end, a length and a width substantially less than the length, the elongate deformable structural member being configured to deploy from a first, un-deployed configuration wherein the elongate deformable structural member is generally straight between the first free end and the second free end to a second configuration wherein the elongate deformable structural member defines a “

C”

-shape, wherein the “

C”

-shape is configured to lie along a plane of the native valve annulus when deployed in the second configuration; and

b) a leaflet having a first arcuate edge and a second, straight edge when the prosthesis is fully deployed, the leaflet extending radially inward from a curved side portion of the elongate deformable structural member when in the second configuration, the first arcuate edge being attached to the elongate deformable structural member and the second straight edge extending from the first free end toward the second free end of the elongate deformable structural member when the elongate deformable structural member is in the second configuration.

2. The deployable valve prosthesis of claim 1, wherein the elongate deformable structural member has a circumferential extent of about 180 degrees when fully deployed.

3. The deployable valve prosthesis of claim 1, wherein the elongate deformable structural member includes shape memory material.

4. The deployable valve prosthesis of claim 3, wherein the shape memory material includes a nickel-titanium alloy.

5. The deployable valve prosthesis of claim 1, wherein the elongate deformable structural member is constructed at least in part of a structural material.

6. The deployable valve prosthesis of claim 1, wherein the prosthesis includes biological material.

7. The deployable valve prosthesis of claim 6, wherein the biological material includes material obtained from a cadaver.

8. The deployable valve prosthesis of claim 6, wherein the biological material includes cellular content.

9. The deployable valve prosthesis of claim 1, wherein the leaflet is formed from a polymeric membrane.

10. The deployable valve prosthesis of claim 9, wherein the leaflet includes ePTFE material.

11. The deployable valve prosthesis of claim 1, wherein the prosthesis is a unitary structure.

12. The deployable valve prosthesis as in claim 1, wherein the elongate deformable structural member is configured for anchoring to an annulus for a mitral valve.

13. The deployable valve prosthesis of claim 1, configured for one of percutaneous delivery and transcatheter delivery to the native lumenal valve.

14. A deployable valve prosthesis for replacing a portion of a native lumenal valve, the native lumenal valve defining a native valve annulus and a plurality of native leaflets, the prosthesis comprising:

a) a self-deployable elongate deformable structural member having a first free end, a second free end, a length and a width substantially less than the length, the elongate deformable structural member being configured to self-deploy from a first, un-deployed configuration wherein the elongate deformable structural member is generally straight between the first free end and the second free end to a second configuration wherein the elongate deformable structural member defines a “

C”

-shape, wherein the “

C”

-shape is configured to lie along a plane of the native valve annulus when deployed in the second configuration, the structural member comprising a scaffolding disposed about a periphery of the C-shape when in the second configuration, the scaffolding is configured for receiving suture for retaining the prosthesis in the native valve annulus; and

b) a leaflet having a first arcuate edge and a second, straight edge when the prosthesis is deployed, the leaflet extending radially inward from a curved side portion of the elongate deformable structural member when in the second configuration, the first arcuate edge being attached to the elongate deformable structural member and the second straight edge extending from the first free end toward the second free end of the elongate deformable structural member when the elongate deformable structural member is in the second configuration.

15. The deployable valve prosthesis of claim 14, configured for one of percutaneous delivery and transcatheter delivery to the native lumenal valve.

16. A deployable valve prosthesis for replacing a portion of a native lumenal valve, the native lumenal valve defining a native valve annulus and a plurality of native leaflets, the prosthesis comprising:

a) a self-deployable elongate deformable structural member having a first free end, a second free end, a length and a width substantially less than the length, the elongate deformable structural member being configured to deploy from a first, un-deployed configuration wherein the elongate deformable structural member is generally straight between the first free end and the second free end to a second configuration wherein the elongate deformable structural member defines a “

C”

-shape, wherein the “

C”

-shape is configured to lie along a plane of the native valve annulus when deployed in the second configuration, the structural member comprising a scaffolding disposed about a periphery of the C-shape, such that when in the second configuration, the scaffolding is configured for retaining the prosthesis in the native valve annulus by use of one of a suture and a clip; and

b) a leaflet having a first arcuate edge and a second, straight edge when the prosthesis is deployed, the leaflet extending radially inward from a curved side portion of the elongate deformable structural member when in the second configuration, the first arcuate edge being attached to the elongate deformable structural member and the second straight edge extending from the first free end toward the second free end of the elongate deformable structural member when the elongate deformable structural member is in the second configuration.

17. The deployable valve prosthesis of claim 16, configured for one of percutaneous delivery and transcatheter delivery to the native lumenal valve.