Artificial venous valve containing therapeutic agent

• US 20070265699A1
• Filed: 04/24/2007
• Published: 11/15/2007
• Est. Priority Date: 04/25/2006
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: MED Institute, Inc. (Cook Group Incorporated)
• Inventors: Grewe, David, Purdy, James
• Granted Patent: US 8,303,648 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/0095 Saddle-shaped
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir

Abstract

The invention relates to a prosthetic valve for regulating flow through a body lumen and delivering a therapeutic agent into said lumen. In one embodiment, the prosthesis includes a frame having an exterior wall, a hollow interior space, a valve member, and at least one aperture through the exterior wall that permits a controlled amount of therapeutic agent loaded into the hollow interior into the surrounding body lumen following implantation. In another embodiment, the prosthesis includes a frame having a groove, a valve member, and therapeutic agent loaded in the groove.

Claims

1. An implantable valve prosthesis comprising:

a frame comprising an exterior wall, the exterior wall defining a hollow interior space, and at least one aperture defining a conduit through the exterior wall;

a valve member operatively connected to the exterior wall, the valve member adapted to modify fluid flow through a body lumen; and

a therapeutic agent loaded in the hollow interior space in such a way so that at least a portion thereof may pass through the aperture.

2. The prosthesis of claim 1, wherein the therapeutic agent is selected from the group consisting of anti-inflammatory/immunomodulators, antiproliferatives, migration inhibitors/ECM-modulators, antithrombotics, and thrombolytics.

3. The prosthesis of claim 1, wherein the therapeutic agent is heparin.

4. The prosthesis of claim 1, wherein the therapeutic agent is hirudin.

5. The prosthesis of claim 1, wherein the valve member comprises a biocompatible material which is operatively connected to the exterior wall such that the biocompatible material substantially encapsulates the at least one aperture.

6. The prosthesis of claim 1, wherein the valve member comprises a biocompatible material which is operatively connected to the exterior wall such that the biocompatible material substantially encapsulates the frame.

7. The prosthesis of claim 1, wherein the frame is selected from the group consisting of stainless steel, nitinol, tantalum, a nonmagnetic cobalt-chromium alloy, platinum, titanium, a suitable biocompatible alloy, a suitable biocompatible polymer, a suitable biocompatible material, and a combination thereof.

8. The prosthesis of claim 1, wherein the at least one aperture is between about 0.0001 inches and about 0.010 inches wide.

9. The prosthesis of claim 1, further comprising:

a reservoir for containing therapeutic agent to be delivered to the frame hollow interior; and

a transport device for dispensing therapeutic agent from the reservoir to the hollow interior;

wherein the transport device comprises a proximal end operatively connected with the reservoir and a distal end operatively connected to the hollow interior to facilitate the delivery of the therapeutic agent to the hollow interior through the transport device.

10. The prosthesis of claim 9, wherein the reservoir comprises biocompatible polyurethane.

11. An implantable valve prosthesis comprising:

a frame comprising a groove;

a valve member operatively connected to the frame; and

a therapeutic agent loaded in the groove.

12. The prosthesis of claim 11, wherein the therapeutic agent is selected from the group consisting of anti-inflammatory/immunomodulators, antiproliferatives, migration inhibitors/ECM-modulators, antithrombotics, and thrombolytics.

13. The prosthesis of claim 11, wherein the therapeutic agent is heparin.

14. The prosthesis of claim 11, wherein the therapeutic agent is hirudin.

15. The prosthesis of claim 11, wherein the groove is between about 0.0001 inches and about 0.010 inches deep and between about 0.0001 inches and about 0.010 inches wide.

16. The prosthesis of claim 11, wherein the valve member comprises a biocompatible material, the biocompatible material substantially encapsulating said groove.

17. The prosthesis of claim 11, wherein the frame is selected from the group consisting of stainless steel, nitinol, tantalum, a nonmagnetic cobalt-chromium alloy, platinum, titanium, a suitable biocompatible alloy, a suitable biocompatible polymer, a suitable biocompatible material, and a combination thereof.

18. The prosthesis of claim 11, further comprising:

at least one reservoir for containing therapeutic agent to be delivered to the frame; and

at least one transport device for dispensing therapeutic agent from the at least one reservoir to the frame;

wherein the at least one transport device comprises a proximal end operatively connected with the at least one reservoir and a distal end operatively connected to the frame to facilitate the delivery of therapeutic agent to the frame through the at least one transport device.

19. The prosthesis of claim 18, wherein the at least one reservoir comprises biocompatible polyurethane.

20. A method of treating valvular insufficiency, comprising the steps of:

providing a valve prosthesis comprising a frame; and

implanting the prosthesis into a patient in need thereof;

wherein the frame is loaded with a therapeutic agent;

wherein the therapeutic agent prevents blood stasis and platelet deposition in the area surrounding implantation.