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

• US 8,491,925 B2
• Filed: 12/02/2011
• Issued: 07/23/2013
• 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., Pollman, Matthew J.
• Primary Examiner(s): BARHAM, BETHANY P
• Application Number:
  US13/310,326
• Publication Number:
  US 20120076920A1
• Time in Patent Office: 599 Days
• Field of Search: None
• US Class Current: 424/422
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61L 2300/204 with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
• 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 2400/00 Materials characterised by their function or physical properties
• 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 29/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 33/0005 Use of materials characterised by their function or physical properties
• 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 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: C08L 33/02 Homopolymers or copolymers of acids; Metal or ammonium salts thereof

Abstract

A method and device for local delivery of a water-insoluble therapeutic agent to the tissue 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 a non-durable coating which comprises poly(HEMA) complexed with iodine and has a substantially water-insoluble therapeutic agent dispersed therein. The medical disposable device is inserted into a body lumen, and expanded to contact the non-durable coating against the body lumen and deliver the substantially water-insoluble therapeutic agent to the body lumen tissue.

Claims

1. A method of coating a catheter balloon comprising:

coating a catheter balloon with a coating solution comprising poly(HEMA), iodine, an organic solvent, and a substantially water-insoluble therapeutic agent; and

drying the catheter balloon to form a water soluble coating on the catheter balloon, wherein the poly(HEMA) is complexed with the iodine in the water soluble coating.

2. The method of claim 1, wherein coating the catheter balloon with a coating solution comprises dip coating the catheter balloon in the coating solution.

3. The method of claim 1, wherein the substantially water-insoluble 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.

4. The method of claim 3, wherein the substantially water-insoluble therapeutic agent is paclitaxel.

5. The method of claim 1, wherein the poly(HEMA) is prepared by atom transfer radical polymerization (ATRP) using a morpholine based initiator (ME-Br).

6. The method of claim 1, wherein the poly(HEMA) has a Mn below 8 KD.

7. The method of claim 6, wherein the poly(HEMA) has a Mn of approximately 7 KD.

8. The method of claim 1, wherein the organic solvent is 2-propanol.

9. The method of claim 1, wherein the coating solution comprises acetone.

10. The method of claim 1, wherein the coating solution comprises propylene glycol.

11. A method of coating a catheter balloon comprising:

coating a catheter balloon with a coating solution comprising poly(HEMA), iodine, an organic solvent, and a substantially water-insoluble therapeutic agent; and

drying the catheter balloon to form a water soluble coating on the catheter balloon, wherein the iodine is non-covalently bound in the water soluble coating.

12. The method of claim 11, wherein coating the catheter balloon with a coating solution comprises dip coating the catheter balloon in the coating solution.

13. The method of claim 11, wherein the substantially water-insoluble 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.

14. The method of claim 11, wherein the substantially water-insoluble therapeutic agent is paclitaxel.

15. The method of claim 11, wherein the poly(HEMA) is prepared by atom transfer radical polymerization (ATRP) using a morpholine based initiator (ME-Br).

16. The method of claim 11, wherein the poly(HEMA) has a Mn below 8 KD.

17. The method of claim 16, wherein the poly(HEMA) has a Mn of approximately 7 KD.

18. The method of claim 11, wherein the organic solvent is 2-propanol.

19. The method of claim 11, wherein the coating solution comprises acetone.

20. The method of claim 11, wherein the coating solution comprises propylene glycol.