MEDICAL DEVICE FOR DISPERSING MEDICAMENTS

• US 20100228228A1
• Filed: 05/19/2010
• Published: 09/09/2010
• Est. Priority Date: 09/20/2002
• Status: Active Grant

• Current Assignee: Bayer Intellectual Property GmbH (Bayer AG)
• Original Assignee: Bayer Intellectual Property GmbH (Bayer AG)
• Inventors: SPECK, Ulrich, Scheller, Bruno
• Granted Patent: US 8,439,868 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• 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 2300/43 Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 29/08 Materials for coatings
• 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 31/08 Materials for coatings
• 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 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• 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 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 39/06 : Free radical scavengers or antioxidants
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system

Abstract

For selective treatment of diseased tissue sections or organ parts, the surface of medical devices entering into contact with areas thereof under pressure is coated with lipophilic substantially water-insoluble medicaments binding to various tissue components with good adherence thereto, said medicaments having an effect thereupon a short time after entering into contact therewith without exerting a harmful influence upon adjacent healthy tissue.

Claims

1-23. -23. (canceled)

24. A balloon catheter medical device comprising a balloon surface having paclitaxel adhered thereto after being applied and dried, wherein said dried paclitaxel is immediately released after coming into contact with tissue.

25. The device according to claim 24, wherein the balloon catheter comprises a stent.

26. The device according to claim 24, wherein the balloon catheter does not comprise a stent.

27. The device according to claim 24, wherein the coated balloon has preformed longitudinal folds maintaining an inclination to refold after inflation.

28. The device according to claim 24, wherein the balloon consists of a very smooth material to which the paclitaxel adheres sufficiently well to resist forces required for folding, essentially without damage.

29. The device according to claim 24, wherein the balloon is coated by immersion in a low-viscosity pacitaxel solution in fully folded condition.

30. The device according to claim 27, wherein the area covered by folds is covered with the paclitaxel.

31. The device according to claim 27, wherein only the area covered by folds is covered with the paclitaxel.

32. The device according to claim 24, wherein the paclitaxel is present as a dry solid on the surface of the balloon.

33. The device according to claim 32, wherein the effective dose of the paclitaxel includes amorphous structures with particle sizes ranging from <

0.1 micron to 5 microns that dissolve quickly due to their large surface area and despite the poor water-solubility of the paclitaxel.

34. The device according to claim 24, wherein the paclitaxel is embedded in a readily water-soluble matrix substance to achieve good adhesion to the surface of the balloon and improve absorption by tissue.

35. The device according to claim 34, wherein the matrix substance is a low-molecular weight substance with a molecular weight <

5000 D.

36. The device according to claim 35, wherein the low-molecular weight substance is hydrophilic.

37. The device according to claim 24, wherein the paclitaxel is absorbed in particles of, or applied to the surface of the balloon with, a low-molecular weight matrix.

38. The device according to claim 24, having a surface additionally coated with a substance that influences the gliding quality of the device or that prevents blood coagulation.

39. A method for producing the device according to claim 24, comprising applying the paclitaxel in a solution, suspension or emulsion medium using an immersion, spreading, or spraying process or an instrument which delivers a defined volume to the surface of the balloon while excess media and substances that adhere loosely to the surface are removed.

40. A method of claim 39, wherein said solution, suspension or emulsion medium further comprises a pharmaceutically acceptable excipient.

41. The method according to claim 39, wherein the coating process is carried out repeatedly to achieve a reproducible increase of the paclitaxel content using the same or different solution, suspension, or emulsion media and/or optional excipient.

42. The method according to claim 41, wherein ethanol, isopropanol ethyl acetate, diethyl ether, acetone, dimethyl sulfoxide, dimethyl formamide, glycerin, water or a mixture thereof is used as solution, suspension, or emulsion medium.

43. The method according to claim 39, wherein the balloon is folded-ready and is used as drug carrier coated prior to or after sterilization with or without a crimped-on stent.

44. The method according to claim 43, wherein the balloon is coated with the paclitaxel in unfolded condition and then the balloon is folded with a lubricating tool optionally wetted with a biocompatible, gliding agent.

45. The method according to claim 39, wherein a stent is attached to the balloon catheter prior to or after coating of the balloon catheter.

46. The method according to claim 39, wherein the completely coated device is sterilized using ethylene oxide.

47. A method for treating a vascular disease or circulation disturbance comprising administering a device of claim 24.

48. A method for creating an open passage in the body comprising administering a device of claim 24.

49. A balloon catheter medical device comprising a balloon surface having paclitaxel adhered thereto after being applied thereon and dried, wherein said dried paclitaxel is immediately released after coming into contact with tissue.

50. A balloon catheter medical device comprising a balloon surface having paclitaxel adhered thereto, without an inert matrix or embedded in a low molecular weight matrix substance, after being applied thereon and dried, wherein said dried paclitaxel is immediately released after coming into contact with tissue.

51. A balloon catheter medical device comprising a balloon surface having paclitaxel adhered thereto, without an inert matrix or embedded in a low molecular weight, readily water-soluble hydrophilic matrix substance having a molecular weight of <

2000 D, after being applied thereon and dried, wherein said dried paclitaxel is immediately released after coming into contact with tissue.

52. A balloon catheter medical device comprising a balloon surface having paclitaxel of a particle size between <

0.1 μ

m and 5 μ

m adhered thereto, without an inert matrix or embedded in a low molecular weight, readily water-soluble hydrophilic matrix substance having a molecular weight of <

2000 D, after being applied thereon and dried, wherein said dried paclitaxel is immediately released after coming into contact with tissue.