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

• US 8,257,722 B2
• Filed: 09/15/2008
• Issued: 09/04/2012
• Est. Priority Date: 09/15/2008
• Status: Active Grant

• Current Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Original Assignee: Cv Ingenuity Corp. (Medtronic Plc)
• Inventors: Michal, Eugene T., Lerner, Daniel J., Pollman, Matthew J.
• Primary Examiner(s): BARHAM, BETHANY P
• Application Number:
  US12/210,344
• Publication Number:
  US 20100069879A1
• Time in Patent Office: 1,450 Days
• Field of Search: None
• US Class Current: 424/422
• 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 an amphiphilic polymer or co-polymer complexed with iodine and a hydrophobic therapeutic agent interdispersed in said amphiphilic polymer or co-polymer complexed with iodine;

wherein at least 90% of said amphiphilic polymer coating is dissolved within 300 seconds of expanding said expandable structure in vivo.

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 (HPC) 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 hydrophobic 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 hydrophobic therapeutic agent is selected from the group consisting of 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 amphiphilic polymer or co-polymer complexed with iodine and at least one hydrophobic therapeutic agent interdispersed in said at least one amphiphilic polymer or co-polymer complexed with iodine;

wherein at least 90% of said coating is dissolved within 300 seconds of expanding said expandable structure in vivo.

11. The medical disposable device of claim 10, wherein said hydrophobic 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 medical disposable device comprising:

an expandable structure having an outer surface; and

a coating layer disposed on the outer surface of the expandable structure, the coating layer comprising non-covalently bound iodine and a hydrophobic therapeutic agent interdispersed throughout an aggregate polymer matrix of the coating layer;

wherein the aggregate polymer matrix is dissolvable in both aqueous and non-aqueous solvents.

16. The medical disposable device of claim 15, wherein the hydrophobic 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 medical disposable device of claim 15, wherein the hydrophobic therapeutic agent is selected from the group consisting of paclitaxel and dexamethasone acetate.

18. The medical disposable device of claim 15, further comprising a sheath which is extendable over and retractable from the expandable structure.

19. The medical disposable device of claim 15, wherein the expandable structure is a balloon of a balloon catheter.

20. The medical disposable device of claim 15, wherein the coating layer further comprises a plasticizer.

21. The medical disposable device of claim 15, wherein the coating layer further comprises a wax.