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

• US 9,034,362 B2
• Filed: 01/08/2014
• Issued: 05/19/2015
• 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): Wax, Robert A
• Assistant Examiner(s): MERCIER, MELISSA S
• Application Number:
  US14/149,862
• Publication Number:
  US 20140221976A1
• Time in Patent Office: 496 Days
• US Class Current: 424/423
• 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 catheter assembly for insertion into the vasculature comprising:

a balloon having an outer surface;

an amphiphilic polymer coating disposed on the outer surface of the balloon, the amphiphilic polymer coating comprising an amphiphilic polymer or co-polymer complexed with iodine, a hydrophobic therapeutic agent, and a plasticizer.

2. The catheter of claim 1, wherein the amphiphilic polymer or co-polymer is selected from the group consisting of hydroxypropyl cellulose, poly (methyl vinyl ether-alt-maleic acid monobutyl ester), poly (methyl vinyl ether-alt-maleic acid monoethyl ester), and polyvinyl pyrrolidone.

3. The catheter of claim 1, wherein the plasticizer is selected from the group consisting of polyethylene glycol with a molecular weight below 10 K Daltons, propylene glycol, triethyl citrate, glycerol, and dibutyl sebacate.

4. The catheter of claim 1, wherein the plasticizer is at a concentration of less than 20% by weight of the at least one amphiphilic polymer or co-polymer complexed with iodine.

5. The catheter of claim 1, wherein the amphiphilic polymer coating further comprises a wax selected from the group consisting of bees wax, carnauba wax, polypropylene glycol, polydimethyl siloxane, and polydimethyl siloxane derivatives.

6. The catheter of claim 5, wherein the wax is at a concentration of less than 1% by weight of the at least one amphiphilic polymer or co-polymer complexed with iodine.

7. The catheter of claim 1, wherein the hydrophobic therapeutic agent is selected from the group consisting of anti-proliferative agents, anti-platelet agents, anti-inflammatory agents, anti-thrombotic agents, thrombolytic agents, and combinations thereof.

8. The catheter of claim 1, wherein the hydrophobic therapeutic agent is selected from the group consisting of paclitaxel and dexamethasone acetate.

9. The catheter of claim 1, further comprising a sheath which is extendable over and retractable from the balloon.

10. A catheter assembly for insertion into the vasculature comprising:

a balloon having an outer surface; and

an amphiphilic polymer coating disposed on the outer surface of the balloon, the amphiphilic polymer coating comprising an amphiphilic polymer or co-polymer complexed with iodine, a hydrophobic therapeutic agent, and a wax.

11. The catheter of claim 10, wherein the amphiphilic polymer or co-polymer is selected from the group consisting of hydroxypropyl cellulose, poly (methyl vinyl ether-alt-maleic acid monobutyl ester), poly (methyl vinyl ether-alt-maleic acid monoethyl ester), and polyvinyl pyrrolidone.

12. The catheter of claim 10, wherein the wax is selected from the group consisting of bees wax, carnauba wax, polypropylene glycol, polydimethyl siloxane, and polydimethyl siloxane derivatives.

13. The catheter of claim 10, wherein the wax is at a concentration of less than 1% by weight of the at least one amphiphilic polymer or co-polymer complexed with iodine.

14. The catheter of claim 10, wherein the 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.

15. The catheter of claim 14, wherein the plasticizer is at a concentration of less than 20% by weight of the at least one amphiphilic polymer or co-polymer complexed with iodine.

16. The catheter of claim 10, wherein the hydrophobic therapeutic agent is selected from the group consisting of anti-proliferative agents, anti-platelet agents, anti-inflammatory agents, anti-thrombotic agents, thrombolytic agents, and combinations thereof.

17. The catheter of claim 10, wherein the hydrophobic therapeutic agent is selected from the group consisting of paclitaxel and dexamethasone acetate.

18. The catheter of claim 10, further comprising a sheath which is extendable over and retractable from the balloon.