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

• US 10,046,093 B2
• Filed: 11/09/2015
• Issued: 08/14/2018
• 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): Love, Trevor
• Application Number:
  US14/935,754
• Publication Number:
  US 20160058916A1
• Time in Patent Office: 1,009 Days
• 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 non-durable coating on a medical disposable device comprising:

a single layer including a matrix comprising a first and second amphiphilic polymer, the first amphiphilic polymer being complexed with iodine; and

a water-insoluble drug being dispersed in the complex of the first amphiphilic polymer and the iodine, wherein said iodine is present in said coating in an amount of 1-30% by weight of said first amphiphilic polymer, wherein at least 90% of the coating is dissolved within 300 seconds of placement in vivo.

2. The coating of claim 1, wherein said first amphiphilic polymer complexed with said iodine is polyvinyl pyrrolidone (PVP).

3. The coating of claim 2, wherein said second amphiphilic polymer is not complexed with iodine.

4. The coating of claim 1, wherein the first amphiphilic polymer and the second amphiphilic polymer are different.

5. The coating of claim 1, wherein at least 90% of the coating is dissolved within 90 seconds of placement in vivo.

6. A non-durable coating on a medical disposable device comprising a single layer including a matrix of an amphiphilic polymer complexed with iodine, and a water-insoluble drug being dispersed in the complex of the amphiphilic polymer and the iodine, wherein said iodine is present in said coating in an amount of 1-30% by weight of the amphiphilic polymer, wherein at least 90% of the coating is dissolved within 300 seconds of placement in vivo.

7. The coating of claim 6, wherein the amphiphilic polymer complexed with iodine is polyvinyl pyrrolidone.

8. The coating of claim 6, wherein at least 90% of the coating is dissolved within 90 seconds of placement in vivo.