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

• US 9,603,973 B2
• Filed: 09/14/2015
• Issued: 03/28/2017
• 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:
  US14/852,790
• Publication Number:
  US 20160000975A1
• Time in Patent Office: 561 Days
• US Class Current: 1/1
• 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 comprising:

coating a medical disposable device having an expandable structure with a polymer coating including a poly(hydroxyethyl methacrylic) acid complexed with iodine and a substantially water-insoluble therapeutic agent;

introducing the medical disposable device into a body lumen;

expanding the expandable structure of the medical disposable device to contact the polymer coating against the body lumen, thereby delivering the substantially water-insoluble therapeutic agent to the body lumen; and

contracting the expandable structure.

2. The method of claim 1, further comprising withdrawing a protective sheath from over the expandable structure prior to expanding the expandable structure.

3. The method of claim 1, further comprising contacting the polymer coating against an atherosclerotic lesion or a restenotic lesion.

4. The method of claim 1, wherein the substantially water-insoluble therapeutic agent is selected from the group consisting of anti-proliferative agents, anti-platelet agents, anti-inflammatory agents, anti-thrombotic agents, and thrombolytic agents.

5. The method of claim 1, wherein the substantially water-insoluble therapeutic agent is paclitaxel.

6. The method of claim 1, wherein at least 50% of the polymer coating is dissolved within 180 seconds of expanding the expandable structure.

7. The method of claim 1, wherein at least 90% of the polymer coating is dissolved within 300 seconds of expanding the expandable structure.

8. The method of claim 1, wherein at least 5% of the substantially water-insoluble therapeutic agent contained in the polymer coating is imparted into tissue of the body lumen within one hour of contracting the expandable structure.

9. The method of claim 1, wherein at least 25% of the substantially water-insoluble therapeutic agent contained in the polymer coating is imparted into tissue of the body lumen within one hour of contracting the expandable structure.

10. A method comprising:

coating a medical disposable device having an expandable structure with a polymer coating including a poly(hydroxyethyl methacrylic) acid, non-covalently bound iodine, and a substantially water-insoluble therapeutic agent;

introducing the medical disposable device into a body lumen;

expanding the expandable structure of the medical disposable device to contact the polymer coating against the body lumen, thereby delivering the substantially water-insoluble therapeutic agent to the body lumen; and

contracting the expandable structure.

11. The method of claim 10, further comprising withdrawing a protective sheath from over the expandable structure prior to expanding the expandable structure.

12. The method of claim 10, further comprising contacting the polymer coating against an atherosclerotic lesion or a restenotic lesion.

13. The method of claim 10, wherein the substantially water-insoluble therapeutic agent is selected from the group consisting of anti-proliferative agents, anti-platelet agents, anti-inflammatory agents, anti-thrombotic agents, and thrombolytic agents.

14. The method of claim 10, wherein the substantially water-insoluble therapeutic agent is paclitaxel.

15. The method of claim 10, wherein at least 50% of the polymer coating is dissolved within 180 seconds of expanding the expandable structure.

16. The method of claim 10, wherein at least 90% of the polymer coating is dissolved within 300 seconds of expanding the expandable structure.

17. The method of claim 10, wherein at least 5% of the substantially water-insoluble therapeutic agent contained in the polymer coating is imparted into tissue of the body lumen within one hour of contracting the expandable structure.

18. The method of claim 10, wherein at least 25% of the substantially water-insoluble therapeutic agent contained in the polymer coating is imparted into tissue of the body lumen within one hour of contracting the expandable structure.