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

• US 10,117,970 B2
• Filed: 03/28/2017
• Issued: 11/06/2018
• 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., Pollman, Matthew J.
• Primary Examiner(s): Sasan, Aradhana
• Application Number:
  US15/471,579
• Publication Number:
  US 20170224875A1
• Time in Patent Office: 588 Days
• Field of Search: None
• 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 disposed on the outer surface of the expandable structure, the non-durable coating including a plasticizer in combination with poly(hydroxyethyl methacrylic) acid complexed with iodine; and

a substantially water-insoluble therapeutic agent dispersed in the non-durable coating.

2. The catheter assembly of claim 1, wherein the plasticizer includes propylene glycol, triethyl citrate, glycerol, or dibutyl sebacate.

3. The catheter assembly of claim 1, wherein the poly(hydroxyethyl methacrylic) acid has a number average molecular weight below 8 KD.

4. The catheter assembly of claim 1, wherein the poly(hydroxyethyl methacrylic) acid is co-polymerized with a monomer including glycidyl methacrylate or acrylic acid.

5. The catheter assembly of claim 1, wherein the substantially water-insoluble therapeutic agent includes anti-proliferative agents, anti-platelet agents, anti-inflammatory agents, anti-thrombotic agents, or thrombolytic agents.

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

7. A catheter assembly comprising:

an expandable structure having an outer surface;

a non-durable coating disposed on the outer surface of the expandable structure, the non-durable coating including a plasticizer in combination with poly(hydroxyethyl methacrylic) acid; and

a substantially water-insoluble therapeutic agent and non-covalently bound iodine dispersed throughout the non-durable coating.

8. The catheter assembly of claim 7, wherein the plasticizer includes propylene glycol, triethyl citrate, glycerol, or dibutyl sebacate.

9. The catheter assembly of claim 7, wherein the poly(hydroxyethyl methacrylic) acid has a number average molecular weight below 8 KD.

10. The catheter assembly of claim 7, wherein the poly(hydroxyethyl methacrylic) acid is co-polymerized with a monomer including glycidyl methacrylate or acrylic acid.

11. The catheter assembly of claim 7, wherein the substantially water-insoluble therapeutic agent includes anti-proliferative agents, anti-platelet agents, anti-inflammatory agents, anti-thrombotic agents, or thrombolytic agents.

12. The catheter assembly of claim 7, wherein the substantially water-insoluble therapeutic agent is paclitaxel.