Local delivery of water-soluble or water-insoluble therapeutic agents to the surface of body lumens

• US 9,198,968 B2
• Filed: 09/11/2009
• Issued: 12/01/2015
• 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., Lerner, Daniel J., Pollman, Matthew J.
• Primary Examiner(s): Barham, Bethany
• Assistant Examiner(s): JAVIER, MELISSA L
• Application Number:
  US12/558,420
• Publication Number:
  US 20100068170A1
• Time in Patent Office: 2,272 Days
• Field of Search: None
• US Class Current: 1/1
• 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 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, non-covalently bound iodine, and an amphiphilic polymer;

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

dip coating an expandable structure of a medical disposable device in the coating solution to form a non-durable coating on the expandable structure,

wherein the non-covalently bound iodine is complexed with the amphiphilic polymer and the water-insoluble drug is dispersed throughout the non-durable coating.

2. The method of claim 1, wherein preparing the second solution comprises dissolving the non-covalently bound iodine in the second lower alcohol, and then adding the amphiphilic polymer.

3. The method of claim 2, further comprising agitating and heating the second solution until the amphiphilic polymer dissolves.

4. The method of claim 1, wherein the first lower alcohol comprises ethanol.

5. The method of claim 1, wherein the second lower alcohol comprises 2-propanol.

6. The method of claim 1, wherein the water-insoluble drug to amphiphilic polymer weight ratio is 25 to 100%.

7. The method of claim 1, wherein the water-insoluble drug is paclitaxel.

8. The method of claim 1, further comprising treating the expandable structure of the medical disposable device in an argon plasma prior to dip coating.

9. The method of claim 1, wherein the amphiphilic polymer is polyvinylpyrrolidone.

10. The method of claim 1, wherein the amphiphilic polymer is hydroxypropyl cellulose.

11. The method of claim 1, wherein dip coating comprises extracting the expandable structure of the medical disposable device from the coating solution at a rate of 0.05 to 0.4 in/min.

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

preparing a coating solution comprising a water-insoluble drug, non-covalently bound iodine, an amphiphilic polymer or co-polymer, and a solvent including acetone; and

applying the coating solution to an expandable structure of a medical disposable device to form a non-durable coating on the expandable structure;

wherein the non-covalently bound iodine is complexed with the amphiphilic polymer and the water-insoluble drug is dispersed throughout the amphiphilic polymer or co-polymer in the non-durable coating.

13. The method of claim 12, wherein the solvent comprises an alcohol.

14. The method of claim 13, wherein the alcohol is ethanol.

15. The method of claim 12, further comprising expanding the expandable structure prior to applying the coating solution.

16. The method of claim 12, wherein the drug is paclitaxel.

17. The method of claim 12, further comprising treating the expandable structure of the medical disposable device in an argon plasma prior to applying the coating solution.

18. The method of claim 12, wherein the amphiphilic polymer is selected from the group consisting of polyvinylpyrrolidone and hydroxypropyl cellulose.

19. The method of claim 12, wherein applying the coating solution comprises dip coating.

20. The method of claim 19, wherein dip coating comprises extracting the expandable structure of the medical disposable device from the coating solution at a rate of 0.05to 0.4 in/min.

21. 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 different from the first lower alcohol, non-covalently bound iodine, and an amphiphilic polymer;

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

dip coating an expandable structure of a medical disposable device in the coating solution to form a non-durable coating on the expandable structure.