Vascular valves having implanted and target configurations and methods of preparing the same

• US 20060212111A1
• Filed: 10/27/2005
• Published: 09/21/2006
• Est. Priority Date: 10/29/2004
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Pavcnik, Dusan, Case, Brian C., Flagle, Jacob A., Obermiller, F. Joseph, Garrison, Michael L.
• Granted Patent: US 7,458,987 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• 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 2/2475 Venous valves
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

Described are vascular valve devices for implantation in a patient. The vascular valve devices are designed to compensate for the retraction characteristics of a remodelable material used to form one or more leaflets. Alternatively, or in addition, the devices are designed to reduce retraction of the remodelable leaflet-forming material. Further described are methods for preparing and using these vascular valve devices.

Claims

1. A vascular valve device for implantation in a patient to form one or more leaflets including tissue of the patient in a target configuration, the valve device comprising:

a frame;

a remodelable covering that retracts upon remodeling, the remodelable covering attached to the frame in a first configuration for implantation, the first configuration having one or more leaflet-forming portions formed from the remodelable covering;

said first configuration adapted wherein upon remodeling of the one or more leaflet-forming portions and consequent retraction, one or more leaflets comprising tissue of the patient in the target valve configuration are formed.

2. The vascular valve device of claim 1, wherein the remodelable covering is attached to the frame such that fibers of the remodelable covering are oriented substantially parallel to a valve orifice created by the one or more leaflets.

3. The vascular valve device of claim 2, wherein the remodelable covering is attached to the frame element such that there is an excess of remodelable covering in said one or more leaflet-forming portions in said first configuration.

4. The vascular valve device of claim 3, wherein the excess of remodelable covering is provided at least in a direction transverse to the valve orifice.

5. The vascular valve device of claim 1, which is a multi-leaflet valve, and wherein each leaflet-forming portion comprises a separate piece of said remodelable covering.

6. The vascular valve device of claim 1, wherein the remodelable covering has been pre-conditioned by stretching.

7. The vascular valve device of claim 3, wherein the excess of remodelable covering is provided at least in a direction substantially parallel to the valve orifice.

8. The vascular valve device of claim 3, wherein the excess of remodelable covering is provided at least in a direction substantially perpendicular to the valve orifice.

9. The vascular valve device of claim 8, wherein the excess of remodelable covering is also provided in a direction substantially parallel to the valve orifice.

10. The vascular valve device of claim 1, wherein the remodelable covering is treated with an agent that reduces retraction of the covering upon remodeling.

11. The vascular valve device of claim 10, wherein the remodelable covering is treated with a crosslinking agent.

12. The vascular valve device of claim 11, wherein the remodelable covering is crosslinked by glycation.

13. The vascular valve device of claim 10, wherein the remodelable covering is crosslinked by subjecting the covering to energy.

14. The vascular valve device of claim 13, wherein the energy is provided by subjecting the covering to ultraviolet light.

15. The vascular valve device of claim 13, wherein the energy is provided by subjecting the covering to heat.

16. The vascular valve device of claim 10, wherein the remodelable covering is treated with an anti-prolifertive agent.

17. The vascular valve device of claim 16, wherein the anti-proliferative agent comprises Paclitaxel.

18. The vascular valve device of claim 16, wherein the anti-proliferative agent comprises a microtubule-inhibiting agent.

19. The vascular valve device of any of claims 1-18, wherein the remodelable covering comprises a collagenous extracellular matrix (ECM).

20. The vascular valve device of claim 19, wherein the ECM comprises a member selected from the group consisting of pericardium, submucosa, basement membrane, and dura mater.

21. The vascular valve device of claim 20, wherein the ECM comprises submucosa.

22. The vascular valve device of any of claims 1-21, wherein the frame comprises a wire structure.

23. The vascular valve device of any of claims 1-22, wherein the frame comprises a superelastic material.

24. A vascular valve device for implantation in a patient to form one or more leaflets comprising tissue of the patient, the valve device comprising a remodelable material treated to reduce retraction of the material upon remodeling and configured to provide one or more leaflet-forming portions that effectively remodel with tissue of the patient to form one or more corresponding leaflets comprising tissue of the patient.

25. The vascular valve device of claim 24, wherein said agent comprises an anti-proliferative agent and the remodelable material is treated by coating the remodelable material with the agent.

26. The vascular valve device of claim 25, wherein said agent comprises Paclitaxel.

27. The vascular valve device of claim 25, wherein said agent comprises a microtubule inhibiting agent.

28. The vascular valve device of any of claims 24-27, wherein the remodelable material comprises an extracellular matrix (ECM).

29. The vascular valve device of claim 28, wherein the ECM comprises a member selected from the group consisting of pericardium, submucosa, basement membrane, and dura mater.

30. The vascular valve device of claim 29, wherein the ECM comprises submucosa.

31. The vascular valve device of any of claims 24-30, wherein the vascular valve device includes a frame to which said one or more leaflet-forming portions are attached.

32. The vascular valve device of claim 31, wherein the frame comprises a superelastic material.

33. A method of preparing a vascular valve device, comprising:

providing a frame;

attaching to the frame a remodelable covering that retracts upon remodeling a first valve configuration;

said first valve configuration adapted wherein upon implantation of the device and remodeling of the covering with the patient'"'"'s tissue and consequent retraction, one or more leaflets comprising tissue of the patient in a target valve configuration are formed.

34. A method of preparing a vascular valve device, comprising:

forming from a remodelable material treated with an agent that reduces retraction of the material, one or more leaflet-forming portions adapted upon remodeling to form one or more leaflets comprising tissue of the patient in a valve configuration.

35. A vascular valve device for implantation in a patient to form one or more leaflets in a target configuration, the valve device comprising:

a frame;

a retractable covering attached to the frame in a first configuration for implantation, the first configuration having one or more leaflet-forming portions formed from the retractable covering and including an adaptation to account for retraction of the retractable covering.