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

• US 8,114,429 B2
• Filed: 03/17/2010
• Issued: 02/14/2012
• 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., Pollman, Matthew J.
• Primary Examiner(s): BARHAM, BETHANY P
• Application Number:
  US12/726,101
• Publication Number:
  US 20100198150A1
• Time in Patent Office: 699 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 catheter assembly comprising:

an expandable structure having an outer surface;

a non-durable coating comprising poly(HEMA) complexed with iodine disposed on the outer surface of the expandable structure; and

a substantially water-insoluble therapeutic agent dispersed in the poly(HEMA) complexed with the iodine.

2. The catheter assembly of claim 1, wherein the non-durable coating is uniformly dissolvable and removable from the outer surface of the expandable structure in an aqueous solvent.

3. The catheter assembly of claim 2, wherein said poly(HEMA) has a Mn molecular weight below 8 KD.

4. The catheter assembly of claim 1, wherein said non-durable coating is dissolvable in bovine serum such that 90%, by volume, of said non-durable coating is removed within 180 seconds of soaking in bovine serum at 37°

C.

5. The catheter assembly of claim 1, wherein said poly(HEMA) is co-polymerized with a monomer.

6. The catheter assembly of claim 5, wherein said monomer is glycidyl methacrylate (GMA).

7. The catheter assembly of claim 5, wherein said monomer is acrylic acid.

8. The catheter assembly of claim 5, wherein said co-polymer is block.

9. A catheter assembly of claim 5, wherein said co-polymer is random.

10. The catheter assembly of claim 1, wherein said iodine is present in said coating at a weight ratio of 1-30% of said coating dry weight.

11. The catheter assembly of claim 1, wherein said substantially water-insoluble therapeutic agent is paclitaxel.

12. The catheter assembly of claim 1, wherein the iodine and the substantially water-insoluble therapeutic agent are dispersed throughout the non-durable coating.

13. A catheter assembly comprising:

an expandable structure having an outer surface;

a non-durable coating disposed on the outer surface of the expandable structure, wherein the non-durable coating comprises poly(HEMA); and

a substantially water-insoluble therapeutic agent and non-covalently bound iodine dispersed throughout the poly(HEMA).

14. The catheter assembly of claim 13, wherein the non-durable coating is uniformly dissolvable and removable from the outer surface of the expandable structure in an aqueous solvent.

15. The catheter assembly of claim 14, wherein the poly(HEMA) has a Mn molecular weight below 8 KD.

16. The catheter assembly of claim 13, wherein the poly(HEMA) is co-polymerized with a monomer.

17. The catheter assembly of claim 16, wherein the monomer is selected from the group consisting of glycidyl methacrylate (GMA) and acrylic acid.

18. The catheter assembly of claim 13, wherein the iodine is present in the coating at a weight ratio of 1-30% of said coating dry weight.

19. The catheter assembly of claim 13, wherein the substantially water-insoluble therapeutic agent is paclitaxel.