DRUG DELIVERY MEDICAL DEVICE

• US 20100239635A1
• Filed: 03/23/2010
• Published: 09/23/2010
• Est. Priority Date: 03/23/2009
• Status: Abandoned Application

• Current Assignee: Micell Technologies Inc.
• Original Assignee: Micell Technologies Inc.
• Inventors: McClain, James B., Taylor, Douglas, Neet, John
• Application Number:
  US12/729,580
• Publication Number:
  US 20100239635A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2300/63 Crystals
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Provided is a coated implantable medical device, comprising: a substrate; and a coating disposed on said substrate, wherein said coating comprises at least one polymer and at least one pharmaceutical agent in a therapeutically desirable morphology and/or at least one active biological agent and optionally, one or more pharmaceutical carrying agents; wherein substantially all of pharmaceutical agent and/or active biological agent remains within said coating and on said substrate until the implantable device is deployed at an intervention site inside the body of a subject and wherein upon deployment of said medical device in the body of said subject a portion of said pharmaceutical agent and/or active biological agent is delivered at said intervention site along with at least a portion of said polymer and/or a at least a portion of said pharmaceutical carrying agents.

Claims

1. A device comprising:

a substrate and

a coating on at least a portion of the substrate,

wherein the coating comprises a plurality of layers,

wherein the coating comprises an active agent, and

wherein the polymer comprises a durable polymer.

2. The device of claim 1, wherein at least one of the polymer and the coating provides at least one of:

strength for the device., and durability for the device

3. The device of claim 1, wherein at least one of the polymer and the coating shields the body lumen from contact with a broken piece of the device.

4. The device of claim 1, wherein at least one of the polymer and the coating is impenetrable by a broken piece of the device.

5. The device of claim 1, wherein the substrate comprises a thin base for the polymer to build upon, and at least one of the polymer and the coating provides at least one of strength and durability in order to withstand a force encountered in the body, wherein the force comprises at least one of:

internal forces, and external forces.

6. The device of claim 1, wherein the coating comprises a fiber reinforcement.

41. The device of claim 1, wherein the active agent comprises a pharmaceutical agent, and wherein at least a portion of the pharmaceutical agent is crystalline.

7. A method comprising

a. providing a substrate and

b. providing a coating on at least a portion of the substrate to form a coated device,

wherein the coating comprises a plurality of layers,

wherein the coating comprises an active agent, and

wherein the polymer comprises a durable polymer.

8. The method of claim 7, wherein at least one of the polymer and the coating provides at least one of:

strength for the device, and durability for the device

9. The method of claim 7, wherein at least one of the polymer and the coating shields the body lumen from contact with a broken piece of the device.

10. The method of claim 7, wherein at least one of the polymer and the coating is impenetrable by a broken piece of the device.

11. The method of claim 7, wherein the substrate comprises a thin base for the polymer to build upon, and at least one of the polymer and the coating provides at least one of strength and durability in order to withstand a force encountered in the body, wherein the force comprises at least one of:

internal forces, and external forces.

12. The method of claim 7, wherein the coating comprises a fiber reinforcement.

42. The method of claim 7, wherein the active agent comprises a pharmaceutical agent, and wherein at least a portion of the pharmaceutical agent is crystalline.

13. A device comprising:

a substrate and

a coating on at least a portion of the substrate,

wherein the coating comprises at least four layers,

wherein the coating comprises an active agent.

14. The device of claim 13, wherein the active agent and polymer are in the same layer;

in separate layers or form overlapping layers.

15. The device of claim 13, wherein the coating comprises at least one of:

at least 10, at least 20, at least 50, and at least 100 layers.

16. The device of claim 13, wherein an active agent layer may be substantially free of polymer and/or a polymer layer may be substantially free of active agent.

17. A method comprising:

c. providing a substrate and

d. providing a coating on at least a portion of the substrate to form a coated device,

wherein the coating comprises at least four layers,

wherein the coating comprises an active agent.

18. The method of claim 17, wherein the active agent and polymer are in the same layer;

in separate layers or form overlapping layers.

19. The method of claim 17, wherein the coating comprises at least one of:

at least 10, at least 20, at least 50, and at least 100 layers.

20. The method of claim 17, wherein an active agent layers may be substantially free of polymer and/or a polymer layers may be substantially free of active agent.

21. A device comprising:

a substrate and

a coating on at least a portion of the substrate,

wherein the coating comprises an active agent,

wherein the coating comprises a plurality of layers, and

wherein the device is adapted for delivery to at least one of a peripheral artery, a peripheral vein, a carotid artery, a vein, an aorta, and a biliary duct.

22. The device of claim 21, wherein the device is adapted for delivery to at least one of:

a superficial femoral artery, a tibial artery, a renal artery, an iliac artery, a bifurcated vessel, a vessel having a side branch at an intended delivery site of the vessel, and a side branch of a vessel.

23. A method comprising:

providing a substrate and

providing a coating on at least a portion of the substrate to form a coated device,

wherein the coating comprises an active agent,

wherein the coating comprises a plurality of layers, and

wherein the device is adapted for delivery to at least one of a peripheral artery, a peripheral vein, a carotid artery, a vein, an aorta, and a biliary duct.

24. The method of claim 23, wherein the device is adapted for delivery to at least one of:

a superficial femoral artery, a tibial artery, a renal artery, an iliac artery, a bifurcated vessel, a vessel having a side branch at an intended delivery site of the vessel, and a side branch of a vessel.

25. A device comprising:

a substrate and

a coating on at least a portion of the substrate,

wherein the coating comprises an active agent,

wherein the coating comprises a plurality of layers, and

wherein the device is configured such that over 1% of said active agent coated on said substrate is delivered to the vessel.

26. The device of claim 25, wherein the device is configured such that at least one of:

over 2% of said active agent coated on said substrate is delivered to the vessel, over 5% of said active agent coated on said substrate is delivered to the vessel, over 10% of said active agent coated on said substrate is delivered to the vessel, over 25% of said active agent coated on said substrate is delivered to the vessel, and over 50% of said active agent coated on said substrate is delivered to the vessel.

27. A method comprising:

providing a substrate and

providing a coating on at least a portion of the substrate, to form a coated device

wherein the coating comprises an active agent,

wherein the coating comprises a plurality of layers, and

wherein the device is configured such that over 1% of said active agent coated on said substrate is delivered to a vessel.

28. The method of claim 27, wherein the device is configured such that at least one of:

over 2% of said active agent coated on said substrate is delivered to the vessel, over 5% of said active agent coated on said substrate is delivered to the vessel, over 10% of said active agent coated on said substrate is delivered to the vessel, over 25% of said active agent coated on said substrate is delivered to the vessel, and over 50% of said active agent coated on said substrate is delivered to the vessel.

29. A device comprising:

a substrate and

a coating on at least a portion of the substrate,

wherein the coating comprises a plurality of layers,

wherein the coating comprises a pharmaceutical agent, and

wherein the device provides an elution profile wherein about 10% to about 50% of pharmaceutical agent is eluted at week 20 after the substrate is implanted in a subject under physiological conditions, about 25% to about 75% of pharmaceutical agent is eluted at week 30 and about 50% to about 100% of pharmaceutical agent is eluted at week 50.

30. The device of claim 29, wherein the pharmaceutical agent is detected in-vitro by elution testing in 37 degree buffered saline at infinite sink conditions.

43. The device of claim 29, wherein at least a portion of the pharmaceutical agent is crystalline.

31. A method comprising:

providing a substrate and

providing a coating on at least a portion of the substrate to form a coated substrate,

wherein the coating comprises a plurality of layers,

wherein the coating comprises a pharmaceutical agent, and

wherein the coated substrate provides an elution profile wherein about 10% to about 50% of pharmaceutical agent is eluted at week 20 after the substrate is implanted in a subject under physiological conditions, about 25% to about 75% of pharmaceutical agent is eluted at week 30 and about 50% to about 100% of pharmaceutical agent is eluted at week 50.

32. The method of claim 31, wherein the pharmaceutical agent is detected in-vitro by elution testing in 37 degree buffered saline at infinite sink conditions.

44. The method of claim 31, wherein at least a portion of the pharmaceutical agent is crystalline.

33. A device comprising:

a substrate and

a coating on at least a portion of the substrate,

wherein the coating comprises a pharmaceutical agent,

wherein the coating comprises a plurality of layers, and

wherein the device provides a release profile whereby the pharmaceutical agent is released over a period longer than 1 month.

34. The device of claim 33, wherein the coating provides a release profile whereby the pharmaceutical agent is released over a period of at least one of:

longer than 2 months, longer than 3 months, longer than 4 months, longer than 6 months, and longer than twelve months.

35. The device of claim 33, wherein the pharmaceutical agent is detected by blood concentration testing.

36. The device of claim 33, wherein the pharmaceutical agent is detected in-vitro by elution testing in 37 degree buffered saline at infinite sink conditions.

37. A method comprising:

providing a substrate and

providing a coating on at least a portion of the substrate to form a coated substrate,

wherein the coating comprises a pharmaceutical agent,

wherein the coating comprises a plurality of layers, and

wherein the device provides a release profile whereby the pharmaceutical agent is released over a period longer than 1 month.

38. The method of claim 37, wherein the coating provides a release profile whereby the pharmaceutical agent is released over a period of at least one of:

longer than 2 months, longer than 3 months, longer than 4 months, longer than 6 months, and longer than twelve months.

39. The device of claim 37, wherein the pharmaceutical agent is detected by blood concentration testing.

40. The device of claim 37, wherein the pharmaceutical agent is detected in-vitro by elution testing in 37 degree buffered saline at infinite sink conditions.