LOADING AND RELEASE OF WATER-INSOLUBLE DRUGS

• US 20080021385A1
• Filed: 08/03/2007
• Published: 01/24/2008
• Est. Priority Date: 08/13/1997
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: BARRY, James, PALASIS, Maria
• Application Number:
  US11/833,717
• Publication Number:
  US 20080021385A1
• Time in Patent Office: Days
• US Class Current: 604/103.02
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61L 2300/222 Steroids, e.g. corticosteroids
• 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 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• 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 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• 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: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: C08L 33/08 : Homopolymers or copolymers of acrylic acid esters
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 75/04 : Polyurethanes

Abstract

A medical device, polymer composition, and method for delivering substantially water-insoluble drugs to tissue at desired locations within the body. At least a portion of the exterior surface of the medical device is provided with a polymer coating. Incorporated in the polymer coating is a solution of at least one substantially water-insoluble drug in a volatile organic solvent. The medical device is positioned to a desired target location within the body, whereupon the drug diffuses out of the polymer coating.

Claims

1. A catheter for delivering a substantially water-insoluble drug at a desired location within a body, comprising:

a catheter for insertion into a body lumen, having a shaft and an expandable balloon at a distal end of the shaft,

said balloon having a polymer coating on at least a portion of an exterior surface,

said polymer coating having a thickness of between about 0.2 and 50 microns, said polymer coating containing at least one substantially water-insoluble drug.

2. The catheter of claim 1, wherein said polymer coating has a thickness of between about 1 and 10 microns.

3. The catheter of claim 1, wherein said polymer coating has a thickness of between about 2 and 5 microns.

4. The catheter of claim 1, wherein said polymer coating has a thickness of between about 0.2 and 0.3 microns.

5. The catheter of claim 1, wherein said polymer coating has a thickness greater than about 10 microns.

6. The catheter of claim 1, wherein said polymer coating is layered.

7. The catheter of claim 1, wherein said polymer is hydrophillic.

8. The catheter of claim 1, wherein said polymer is hydrophobic.

9. The catheter of claim 1, wherein said polymer is a polyvinyl aromatic.

10. The catheter of claim 1, wherein said at least one substantially water-insoluble drug is paclitaxel.

11. The catheter of claim 1, wherein said at least one water-insoluble drug comprises a combination of paclitaxel and an agent selected from the group consisting of anti-coagulants, anti-mitotics, anti-thrombogenics, thrombolytics, anti-inflammatory agents, nitric oxide containing polymers, or vascular cell promoters.

12. The catheter of claim 1, wherein said at least one water-insoluble drug is released from said stent over a time frame effective to inhibit proliferative disease when said catheter is positioned at a site of injury to thereby prevent or inhibit undesired cellular proliferation.

13. A method of preparing a balloon catheter having a balloon with a substantially water-insoluble drug coating comprising:

dissolving at least one substantially water-insoluble drug in an organic solvent to create a drug solution; and

applying said drug solution to at least a portion of an exterior surface of the balloon.

14. The method of claim 13, further comprising the step of coating at least a portion of the exterior surface of said balloon with a polymer to form a polymer coating prior to applying said drug solution to at least a portion of the exterior surface of said balloon.

15. The method of claim 14, further comprising the step of evaporating said organic solvent from said polymer coating after applying said drug solution.

16. The method of claim 15, wherein the step of evaporating the organic solvent from said polymer coating is performed in a vacuum oven.

17. The method of claim 13, wherein said drug solution is applied by dipping, dripping, spraying, or pipeting.

18. The method of claim 15, further comprising the step of applying an additional modifying or modulating layer after evaporating said organic solvent.

19. The method of claim 18, wherein said additional modifying or modulating layer comprises a polymer.

20. The method of claim 18, wherein said additional modifying or modulating layer comprises a drug.

21. The method of claim 18, wherein the additional modifying or modulating layer has a thickness of less than about 5000 angstroms.

22. The method of claim 18, wherein the additional modifying or modulating layer has a thickness of between about 50 and 2000 angstroms.

23. The method of claim 14, wherein said polymer coating has a thickness of between about 1 and 10 microns.

24. The method of claim 14, wherein said polymer coating has a thickness of between about 2 and 5 microns.

25. The method of claim 13, wherein the organic solvent is chosen from the group consisting of:

ethanol, isopropanol, chloroform, acetone, pentane, hexane, and methylene chloride.

26. The method of claim 13, wherein the organic solvent is chloroform.

27. The method of claim 13, wherein said at least one substantially water-insoluble drug is paclitaxel.

28. The method of claim 13, wherein said at least one water-insoluble drug comprises a combination of paclitaxel and an agent selected from the group consisting of anti-coagulants, anti-mitotics, anti-thrombogenics, thrombolytics, anti-inflammatory agents, nitric oxide containing polymers, or vascular cell promoters.

29. A method of preparing a balloon catheter having a balloon with a substantially water-insoluble drug coating, comprising:

a catheter for insertion into a body lumen, having a shaft and an expandable balloon at a distal end of the shaft,

said balloon having a polymer coating on at least a portion of an exterior surface,

said polymer coating having a thickness of between about 0.2 and 50 microns,

said polymer coating containing at least one substantially water-insoluble drug, said method comprising the steps of;

dissolving said at least one substantially water-insoluble drug in an organic solvent to create a drug solution; and

applying said drug solution to at least a portion of the exterior surface of said balloon.