LOCAL DELIVERY OF WATER-SOLUBLE OR WATER-INSOLUBLE THERAPEUTIC AGENTS TO THE SURFACE OF BODY LUMENS

• US 20100069879A1
• Filed: 09/15/2008
• Published: 03/18/2010
• Est. Priority Date: 09/15/2008
• Status: Active Grant

• Current Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Original Assignee: CV Ingenuity Corporation
• Inventors: Pollman, Matthew J., Lerner, Daniel J., Michal, Eugene T.
• Granted Patent: US 8,257,722 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/216 with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/141 Plasticizers
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A method and device for local delivery of water-soluble or water-insoluble therapeutic agents to the surface of a normal or diseased body lumen is disclosed. An expandable structure of a medical disposable device, such as a balloon of a balloon catheter, is coated with an amphiphilic polymer coating comprising a therapeutic agent and an amphiphilic polymer or co-polymer. The medical disposable device is inserted into a body lumen, and expanded to contact the amphiphilic polymer coating against the body lumen. The total solubility of the polymer or co-polymer in vivo prevents any embolic hazard associated with the amphiphilic polymer coating.

Claims

1. A medical disposable device comprising:

an expandable structure having an outer surface; and

an amphiphilic polymer coating disposed on the outer surface of the expandable structure, said amphiphilic polymer coating comprising a therapeutic agent and an amphiphilic polymer or co-polymer complexed with iodine.

2. The medical disposable device of claim 1, wherein said amphiphilic polymer or co-polymer is a non-ionizable thermoplastic.

3. The medical disposable device of claim 2, wherein said amphiphilic polymer or co-polymer is selected from the group consisting of hydroxypropyl cellulose (UPC) and polyvinyl pyrrolidone (PVP).

4. The medical disposable device of claim 2, wherein said amphiphilic polymer coating further comprises a plasticizer selected from the group consisting of polyethylene glycol with a molecular weight below 10 K Daltons, propylene glycol, triethyl citrate, glycerol, and dibutyl sebacate.

5. The medical disposable device of claim 2, wherein said amphiphilic polymer coating further comprises a wax selected from the group consisting of bees wax, carnauba wax, polypropylene glycol, polydimethyl siloxane (PDMS), and PDMS derivatives.

6. The medical disposable device of claim 2, wherein said therapeutic agent is selected from the group consisting of an anti-proliferative agent, anti-platelet agent, anti-inflammatory agent, anti-thrombotic agent, and thrombolytic agent.

7. The medical disposable device of claim 2, wherein said therapeutic agent is paclitaxel and dexamethasone acetate.

8. The medical disposable device of claim 2, further comprising a sheath which is extendable over and retractable from said expandable structure.

9. The medical disposable device of claim 2, wherein said expandable structure is a balloon of a balloon catheter.

10. A medical disposable device comprising:

an expandable structure having an outer surface; and

a coating disposed on the outer surface of the expandable structure, said coating consisting essentially of at least one therapeutic agent and at least one amphiphilic polymer or co-polymer complexed with iodine.

11. The medical disposable device of claim 10, wherein said therapeutic agent is selected from the group consisting of an anti-proliferative agent, anti-platelet agent, anti-inflammatory agent, anti-thrombotic agent, and thrombolytic agent.

12. The medical disposable device of claim 10, wherein said coating further comprises a plasticizer at a concentration of less than 20% wt of said at least one amphiphilic polymer or co-polymer complexed with iodine.

13. The medical disposable device of claim 10, wherein said coating further comprises a wax at a concentration of less than 1% wt of said at least one amphiphilic polymer or co-polymer complexed with iodine.

14. The medical disposable device of claim 10, wherein said expandable structure is a balloon of a balloon catheter.

15. A method of coating a medical disposable device comprising:

providing a medical disposable device having an expandable portion; and

forming an amphiphilic polymer coating on an outer surface of said expandable portion;

wherein said amphiphilic polymer coating comprises a therapeutic agent and an amphiphilic polymer or co-polymer complexed with iodine.

16. The method of claim 15, wherein said therapeutic agent is selected from the group consisting of an anti-proliferative agent, anti-platelet agent, anti-inflammatory agent, anti-thrombotic agent, and thrombolytic agent.

17. The method of claim 15, wherein said amphiphilic polymer coating is substantially uniform over the outer surface.

18. The method of claim 15, wherein said amphiphilic polymer coating further comprising a component selected from the group consisting of a plasticizer and a wax.

19. The method of claim 15, wherein forming said amphiphilic polymer coating comprises dip coating said expandable portion in a coating solution.

20. The method of claim 19, wherein said amphiphilic polymer coating is formed utilizing a single dip in said coating solution.

21. The method of claim 19, wherein said coating solution comprises said one or more amphiphilic polymer or co-polymer and said therapeutic agent dissolved in a majority or exclusively non-aqueous solvent.

22. The method of claim 19, wherein said coating solution has a viscosity of 5 cps to 75 cps.

23. The method of claim 19, further comprising expanding said expandable portion prior to dipping said expandable portion in said coating solution.

24. A method of delivering a therapeutic agent to a body lumen comprising:

providing a medical disposable device having an amphiphilic polymer coating disposed on an expandable structure of the medical disposable device, wherein said amphiphilic polymer coating comprises a therapeutic agent and an amphiphilic polymer or co-polymer complexed with iodine;

introducing said medical disposable device into a body lumen; and

expanding said expandable structure of said medical disposable device to contact said amphiphilic polymer coating against said body lumen.

25. The method of claim 24, wherein said therapeutic agent is selected from the group consisting of an anti-proliferative agent, anti-platelet agent, anti-inflammatory agent, anti-thrombotic agent, and thrombolytic agent.

26. The method of claim 24, wherein at least 90% of said amphiphilic polymer coating is dissolved within 300 seconds of said expanding.

27. The method of claim 24, comprising retracting a sheath from over said expandable structure after introducing said medical disposable device into a body lumen and prior to expanding said expandable structure.

28. A medical disposable device comprising:

an expandable structure having an outer surface; and

an amphiphilic polymer coating disposed on the outer surface of the expandable structure, said amphiphilic polymer coating comprising a therapeutic agent and an amphiphilic polymer or co-polymer selected from the group consisting of hydroxypropyl cellulose (HPC), poly (methyl vinyl ether-alt-maleic acid monobutyl ester), and poly (methyl vinyl ether-alt-maleic acid monoethyl ester).

29. The medical disposable device of claim 28, wherein said therapeutic agent is selected from the group consisting of an anti-proliferative agent, anti-platelet agent, anti-inflammatory agent, anti-thrombotic agent, and thrombolytic agent.

30. The medical disposable device of claim 28, further comprising a sheath which is extendable over and retractable from said expandable structure.

31. A method of coating a medical disposable device comprising:

providing a medical disposable device having an expandable portion; and

forming an amphiphilic polymer coating on an outer surface of said expandable portion;

wherein said amphiphilic polymer coating comprises a therapeutic agent and an amphiphilic polymer or co-polymer selected from the group consisting of hydroxypropyl cellulose (UPC), poly (methyl vinyl ether-alt-maleic acid monobutyl ester), and poly (methyl vinyl ether-alt-maleic acid monoethyl ester).

32. The method of claim 31, wherein said therapeutic agent is selected from the group consisting of an anti-proliferative agent, anti-platelet agent, anti-inflammatory agent, anti-thrombotic agent, and thrombolytic agent.

33. The method of claim 31, wherein forming said amphiphilic polymer coating comprises dip coating said expandable portion in a coating solution utilizing a single dip.

34. The method of claim 31, wherein said amphiphilic polymer coating is substantially uniform over the outer surface, and said coating solution has a viscosity of 5 cps to 75 cps.

35. A method of delivering a therapeutic agent to a body lumen comprising:

providing a medical disposable device having an amphiphilic polymer coating disposed on an expandable structure of the medical disposable device, wherein said amphiphilic polymer coating comprises a therapeutic agent and an amphiphilic polymer or co-polymer selected from the group consisting of hydroxypropyl cellulose (UPC), poly (methyl vinyl ether-alt-maleic acid monobutyl ester), and poly (methyl vinyl ether-alt-maleic acid monoethyl ester);

introducing said medical disposable device into a body lumen; and

expanding said expandable structure of said medical disposable device to contact said amphiphilic polymer coating against said body lumen.

36. The method of claim 35, wherein said therapeutic agent is selected from the group consisting of an anti-proliferative agent, anti-platelet agent, anti-inflammatory agent, anti-thrombotic agent, and thrombolytic agent.

37. The method of claim 35, wherein at least 90% of said amphiphilic polymer coating is dissolved within 300 seconds of said expanding.

38. The method of claim 35, comprising retracting a sheath from over said expandable structure after introducing said medical disposable device into a body lumen and prior to expanding said expandable structure.