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

• US 20100068170A1
• Filed: 09/11/2009
• Published: 03/18/2010
• Est. Priority Date: 09/15/2008
• Status: Active Grant

• Current Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Original Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Inventors: Michal, Eugene T., Pollman, Matthew J., Lerner, Daniel J.
• Granted Patent: US 9,198,968 B2
• Time in Patent Office: Days
• US Class Current: 424/78.170
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61L 2300/114 Nitric oxide, i.e. NO
• CPC Class Codes: A61L 2300/216 with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 29/10 Inorganic materials
• CPC Class Codes: A61L 29/106 Inorganic materials other than carbon
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

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, wherein said iodine is present in said coating at a weight ratio of 1-30% of said amphiphilic polymer or co-polymer complexed with said iodine.

2. The medical disposable device of claim 1, wherein said therapeutic agent is present on said outer surface at a density of approximately 0.1-10.0 μ

g/mm².

3. The medical disposable device of claim 1, wherein said amphiphilic polymer coating has a therapeutic agent to polymer matrix weight ratio from 25-100%.

4. The medical disposable device of claim 1, wherein said polymer matrix comprises a plasticizer and said amphiphilic polymer or co-polymer complexed with said iodine.

5. The medical disposable device of claim 1, wherein said amphiphilic polymer or co-polymer is selected from the group consisting of hydroxypropyl cellulose (HPC) and polyvinyl pyrrolidone (PVP).

6. A coating on a medical disposable device comprising:

a first amphiphilic polymer complexed with iodine;

a second amphiphilic polymer; and

a drug

wherein said iodine is present in said coating at a weight ratio of 1-30% of said first amphiphilic polymer complexed with said iodine.

7. The coating of claim 6, wherein said first amphiphilic polymer comprises 25-100 wt % of the total weight of the first and second amphiphilic polymers.

8. The coating of claim 6, wherein said first amphiphilic polymer complexed with said iodine is PVP.

9. The coating of claim 8, wherein said second amphiphilic polymer is not complexable with iodine.

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

preparing a first solution comprising a water-insoluble drug, a first lower alcohol and acetone;

preparing a second solution comprising a second lower alcohol, iodine and an amphiphilic polymer;

mixing said first and second solutions to form a coating solution; and

dip coating an expandable structure of a medical disposable device in said coating solution.

11. The method of claim 10, wherein preparing said second solution comprises dissolving said iodine in said second lower alcohol, and then adding said amphiphilic polymer.

12. The method of claim 11, further comprising agitating and heating the second solution until the amphiphilic polymer dissolves.

13. The method of claim 10, wherein said first lower alcohol comprises ethanol.

14. The method of claim 10, wherein said second lower alcohol comprises 2-propanol.

15. The method of claim 10, wherein said drug to amphiphilic polymer weight ratio is 25 to 100%.

16. The method of claim 10, wherein said drug is paclitaxel.

17. The method of claim 10, further comprising treating said expandable structure of said medical disposable device in an argon plasma prior to said dip coating.

18. The method of claim 10, wherein said amphiphilic polymer is PVP.

19. The method of claim 10, wherein said amphiphilic polymer is HPC.

20. The method of claim 10, wherein said dip coating comprises extracting said expandable structure of said medical disposable device from said coating solution at a rate of 0.05 to 0.4 in/min.