Medical apparatus having protective, lubricious coating

• US 5,272,012 A
• Filed: 01/29/1992
• Issued: 12/21/1993
• Est. Priority Date: 06/23/1989
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Opolski, Margaret P.
• Primary Examiner(s): LUSIGNAN, MICHAEL R
• Application Number:
  US07/827,362
• Time in Patent Office: 692 Days
• Field of Search: 427/2, 428/423.1, 428/423.7, 428/447, 604/96, 604/265, 606/194
• US Class Current: 428/423.1
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: C08G 18/833 by nitrogen containing compounds by azo compounds C08G18/85
• CPC Class Codes: C08J 2367/02 Polyesters derived from dicarboxylic acids and dihydroxy compounds; C08J2367/06 takes precedence
• CPC Class Codes: C08J 7/0427 with only one layer of a composition containing a polymer binder with more layers C08J7/042
• CPC Class Codes: C08J 7/043 Improving the adhesiveness of the coatings per se, e.g. forming primers adhesives in the form of films or foils characterised by the primer layers between the polymer carriers and the adhesives C09J7/50
• CPC Class Codes: C08J 7/046 Forming abrasion-resistant coatings; Forming surface-hardening coatings
• CPC Class Codes: C08J 7/056 Forming hydrophilic coatings
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: C08L 83/00 Compositions of macromolecular compounds obtained by reactions forming in the main chain of the macromolecule a linkage containing silicon with or without sulfur, nitrogen, oxygen or carbon only; Compositions of derivatives of such polymers
• CPC Class Codes: C09D 175/04 Polyurethanes
• CPC Class Codes: Y10T 428/31551 Of polyamidoester [polyurethane, polyisocyanate, polycarbamate, etc.]
• CPC Class Codes: Y10T 428/31565 Next to polyester [polyethylene terephthalate, etc.]
• CPC Class Codes: Y10T 428/31663 As siloxane, silicone or silane

Abstract

A method for providing a medical apparatus with a protective, lubricious coating is described. The method comprises providing a coating solution which contains a protective compound such as a urethane, a slip additive such as a siloxane, and optionally, a crosslinking agent for the protective compound such as a polyfunctional aziridine, coating the solution onto a surface of a medical apparatus and allowing the coating to set. The resulting surface coating is lubricious, tough and flexible. The coating is well suited for use with materials used as components of balloon catheters.

Claims

1. A method for providing a protective, lubricious coating on a surface of a medical apparatus, the method comprising:

applying a coating solution to a surface of the medical apparatus such that a protective, lubricious layer is formed upon the apparatus surface,

wherein the coating solution comprises a protective compound and a slip additive and the formed layer contains the protective compound as a binder to maintain domains of the slip additive such that lubricating amounts of the slip additive are exposed to provide lubricity.

2. A method as claimed in claim 1 wherein the coating solution in the applying step further comprises a crosslinking agent for the protective compound.

3. A method as claimed in claim 2 wherein the crosslinking agent enhances the adhesion of the coating to the medical apparatus.

4. A method as claimed in claim 2 wherein the crosslinking agent is aziridine.

5. A method as claimed in claim 2 wherein the crosslinking agent is a carbodiimide.

6. A method as claimed in claim 1 wherein in the applying step, the protective compound in the formed layer is crosslinked.

7. A method as claimed in claim 6 wherein the protective compound is crosslinked to itself and to functional moieties derived from the medical apparatus.

8. A method as claimed in claim 7 wherein the functional moieties derived from the medical apparatus are from the material from which the apparatus is made.

9. A method as claimed in claim 7 wherein the functional moieties derived from the medical apparatus are from a primer layer.

10. A method as claimed in claim 1 wherein in the applying step, the protective compound is dispersed in an aqueous solution.

11. A method as claimed in claim 10 wherein the aqueous solution of the protective compound has a solids content from about 2% to about 80% by weight.

12. A method as claimed in claim 11 wherein the solids content is from about 10 to about 50 weight percent.

13. A method as claimed in claims 1 or 10 wherein in the applying step, the protective compound is a urethane.

14. A method as claimed in claims 1 or 10 wherein in the applying step, the protective compound is an acrylic.

15. A method as claimed in claim 13 wherein the urethane is dispersed in an aqueous solution containing triethylamine and N methyl 2 pyrrolidone.

16. A method as claimed in claim 1 wherein the slip additive in the applying step is hydrophobic.

17. A method as claimed in claim 1 wherein the slip additive in the applying step is hydrophilic.

18. A method as claimed in claim 1 wherein the slip additive is a silicon containing compound.

19. A method as claimed in claim 18 wherein the slip additive is a silicone.

20. A method as claimed in claim 18 wherein the slip additive is a siloxane.

21. A method as claimed in claim 20 wherein the siloxane is dimethyl siloxane.

22. A method as claimed in claim 17 wherein the slip additive is a polyvinyl pyrrolidone copolymer.

23. A method as claimed in claim 1 wherein the slip additive in the applying step is in the form of an emulsion.

24. A method as claimed in claim 23 wherein the coating solution in the applying step further comprises a pigment.

25. A method as claimed in claim 23 wherein the coating solution in the applying step further comprises a radioopaque compound.

26. A method as claimed in claim 23 wherein the coating solution in the applying step further comprises a therapeutic agent.

27. A method as claimed in claim 23 wherein the coating solution in the applying step further comprises an antimicrobial agent.

28. A method as claimed in claim 1 wherein the surface of the medical apparatus in the applying step is made of a material having moieties capable of crosslinking with the protective compound.

29. A method as claimed in claim 28 wherein the moieties capable of crosslinking are carboxyl moieties.

30. A method as claimed in claim 1 wherein the surface of the medical apparatus in the applying step is made of polyethylene terephthalate.

31. A method as claimed in claim 1 wherein the surface of the medical apparatus in the applying step is coated with a primer.

32. A method as claimed in claim 31 wherein the primer has functional moieties capable of crosslinking with the protective compound.

33. A method as claimed in claim 32 wherein the functional moieties are carboxyl moieties.

34. A method as claimed in claim 31 wherein the primer comprises ethylene acrylic acid.

35. A method as claimed in claim 1 wherein the medical apparatus in the applying step comprises a balloon.

36. A method as claimed in claim 1 wherein the medical apparatus in the applying step comprises a catheter.

37. A method as claimed in claim 1 wherein the medical apparatus in the applying step comprises a guidewire.

38. A method for providing a protective, lubricious coating on a surface of a medical apparatus, the method comprising:

applying a coating solution to a surface of the medical apparatus such that a protective, lubricious layer comprising a binder of a protective, lubricious layer comprising a binder of a protective compound containing domains of a slip additive is formed upon the apparatus surface,

wherein the coating solution comprises the protective compound and lubricating amounts of the slip additive and the formed layer contains the protective compound being cross-linked to both itself and to functional moieties derived from the medical apparatus.

39. A method as claimed in claim 38 wherein the coating solution in the applying step further comprises a crosslinking agent for the protective compound.

40. A method as claimed in claim 39 wherein the crosslinking agent enhances the adhesion of the coating to the medical apparatus.

41. A method as claimed in claim 39 wherein the crosslinking agent is aziridine.

42. A method as claimed in claim 39 wherein the crosslinking agent is carbodiimide.

43. A method as claimed in claim 38 wherein the functional moieties derived from the medical apparatus are from the material from which the apparatus is made.

44. A method as claimed in claim 38 wherein the functional moieties derived from the medical apparatus are from a primer layer.

45. A method as claimed in claim 38 wherein in the applying step, the protective compound is dispersed in an aqueous solution.

46. A method as claimed in claim 38 wherein in the applying step, the protective compound is a urethane.

47. A method as claimed in claim 38 wherein the slip additive in the applying step is hydrophobic.

48. A method as claimed in claim 38 wherein the slip additive in the applying step is hydrophilic.

49. A method for providing a protective, lubricious coating on surfaces of medical apparatus, the method comprising:

applying a coating solution comprising a protective compound and a silicon containing compound to a surface of the medical apparatus; and

forming a protective, lubricious layer upon the apparatus surface containing the protective compound and lubricating amounts of the silicon containing compound, the formed layer comprising the protective compound as a binder to maintain domains of the slip additive.

50. A medical apparatus having a protective, lubricious surface coating, the coating comprising a binder formed of the protective compound and lubricating amounts of a slip additive such that the binder maintains domains of the slip additive.

51. An apparatus as claimed in claim 50 wherein the coating further comprises a crosslinking agent.

52. An apparatus as claimed in claim 51 wherein the crosslinking agent is aziridine.

53. An apparatus as claimed in claim 51 wherein the crosslinking agent is carbodiimide.

54. An apparatus as claimed in claim 50 wherein the protective compound is a urethane.

55. An apparatus as claimed in claim 50 wherein the slip additive is hydrophobic.

56. An apparatus as claimed in claim 50 wherein the slip additive is hydrophilic.

57. An apparatus as claimed in claim 50 wherein the slip additive is a silicone or siloxane.

58. An apparatus as claimed in claim 57 wherein the slip additive is dimethyl siloxane.

59. An apparatus as claimed in claim 50 wherein the surface upon which the coating is applied comprises polyethylene terephthalate.

60. An apparatus as claimed in claim 50 which comprises a balloon.

61. An apparatus as claimed in claim 50 which comprises a catheter.

62. An apparatus as claimed in claim 50 which comprises a guidewire.

63. An apparatus as claimed in claim 50 having a primer layer disposed between the coating and surface.

64. An apparatus as claimed in claim 63 wherein the primer layer has a functionality suitable for crosslinking with the coating.

65. An apparatus as claimed in claim 64 wherein the functionality is a carboxyl functionality.

66. An apparatus as claimed in claim 63 wherein the primer layer comprises ethylene acrylic acid.

67. An apparatus as claimed in claim 50 wherein the slip additive is hydrophilic and can be bound to both the protective compound and a functionality group derived from the medical apparatus.

68. An apparatus as claimed in claim 50 wherein the coating further comprises a pigment.

69. An apparatus as claimed in claim 50 wherein the coating further comprises a radioopaque compound.

70. An apparatus as claimed in claim 50 wherein the coating further comprises a therapeutic agent.

71. An apparatus as claimed in claim 50 wherein the coating further comprises an antimicrobial agent.

72. A medical apparatus having a protective, lubricious surface coating, the coating comprising a protective compound and a slip additive, the protective compound being crosslinked to moieties derived from the medical apparatus thereby strengthening the overall coating.

73. A medical apparatus having a protective, lubricious surface coating, the coating comprising a binder formed of a protective compound to maintain domains of lubricating amounts of a silicon containing compound for enhancing the lubricity of the coating.