Hydrophilic coatings for medical implements

• US 20030207987A1
• Filed: 05/01/2002
• Published: 11/06/2003
• Est. Priority Date: 05/01/2002
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Leong, Koon-Wah
• Granted Patent: US 7,015,262 B2
• Time in Patent Office: Days
• US Class Current: 524/601
• CPC Class Codes: A61L 29/08 Materials for coatings
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: C08L 67/02 Polyesters derived from dicarboxylic acids and dihydroxy compounds C08L67/06 takes precedence

Abstract

Compositions, methods, devices and kits utilizing water-based hydrophilic coating formulations on medical implements. The composition for applying a coating comprises a sulfonated polyester, water, and a surface active agent. Methods for coating a medical implement comprise providing an aqueous dispersion comprising sulfonated polyester and surface active agent, contacting the medical implement with the aqueous dispersion, and drying the medical implement. Methods for acquiring a sample of bodily fluid from a patient comprise coating a needle with a sulfonated polyester, penetrating the needle into the patient, and drawing bodily fluid through the needle.

Claims

1. A composition for coating of medical implements, comprising:

(a) a sulfonated polyester;

(b) water; and

(c) a surface active agent.

2. The composition of claim 1, wherein said sulfonated polyester comprises a sulfonated poly(alkylene phthalate).

3. The composition of claim 1, wherein comprises a sulfonated poly(ethylene isophthalate).

4. The composition of claim 1, wherein said sulfonated polyester comprises poly(ethylene 4-sodiosulfenyl isophthalate).

5. The composition of claim 1, wherein said sulfonated polyester comprises a polymeric compound having the structure

6. The composition of claim 1, wherein said sulfonated polyester comprises a polymeric compound having the structure

7. The composition of claim 1, wherein said sulfonated polyester comprises a polymeric compound having the structure

8. The composition of claim 1, wherein said sulfonated polyester comprises a polymeric compound having the structure

9. The composition of claim 1, wherein said surface active agent comprises a poly oxyethylene-co-oxypropylene block copolymer.

10. The composition of claim 1, wherein said surface active agent comprises a ethylene oxide-propylene oxide-ethylene oxide triblock copolymer.

11. The composition of claim 1, wherein said surface active agent comprises a N-oleyl-N-methyl taurate.

12. The composition of claim 1, wherein said surface active agent comprises a di-isooctylsulphosuccinate.

13. The composition of claim 1, wherein said surface active agent comprises at least one surfactant from the group consisting of poly oxyethylene-co-oxypropylene block copolymer, ethylene oxide-propylene oxide-ethylene oxide triblock copolymer, N-oleyl-N-methyl taurate, and di-isooctylsulphosuccinate.

14. The composition of claim 1, wherein said contact angle of water for the coating, ranges from approximately 3 to 15 degrees.

15. The composition of claim 1, wherein said contact angle of water for the coating, ranges from approximately 7 to 9 degrees.

16. The composition of claim 1, wherein the medical implement comprises a needle.

17. A composition for applying a hydrophilic coating to a surface of a medical implement;

comprising;

(a) between approximately 0.5% and approximately 30% of sulfonated polyester by weight;

(b) between approximately 0.1% and approximately 5% of surface active agent by weight; and

(c) between approximately 65% and approximately 99.4% of water by weight.

18. The composition of claim 17, wherein said sulfonated polyester comprises a sulfonated poly(alkylene phthalate).

19. The composition of claim 17, wherein comprises a sulfonated poly(ethylene isophthalate).

20. The composition of claim 17, wherein said sulfonated polyester comprises poly(ethylene 4-sodiosulfenyl isophthalate).

21. The composition of claim 17, wherein said sulfonated polyester comprises a polymeric compound having the structure

22. The composition of claim 17, wherein said sulfonated polyester comprises a polymeric compound having the structure

23. The composition of claim 17, wherein said sulfonated polyester comprises a polymeric compound having the structure

24. The composition of claim 17, wherein said sulfonated polyester comprises a polymeric compound having the structure

25. The composition of claim 17, wherein said surface active agent comprises a poly (oxyethylene-co-oxypropylene) block copolymer.

26. The composition of claim 17, wherein said surface active agent comprises a ethylene oxide-propylene oxide-ethylene oxide triblock copolymer.

27. The composition of claim 17, wherein said surface active agent comprises a N-oleyl-N-methyl taurate.

28. The composition of claim 17, wherein said surface active agent comprises a di-isooctylsulphosuccinate.

29. The composition of claim 17, wherein said surface active agent comprises at least one surfactant from the group consisting of poly(oxyethylene-co-oxypropylene) block copolymer, ethylene oxide-propylene oxide-ethylene oxide triblock copolymer, N-oleyl-N-methyl taurate, and di-isooctylsulphosuccinate.

30. A method for forming a hydrophilic coating on a medical implement, comprising:

(a) providing an aqueous dispersion comprising sulfonated polyester and surface active agent;

(b) contacting said medical implement in said aqueous dispersion; and

(c) drying said medical implement.

31. The method of claim 30 wherein providing an aqueous dispersion of said sulfonated polyester and surface active agent comprises between approximately 0.5% and approximately 30% of sulfonated polyester by weight in water and between approximately 0.1% and approximately 5% of surface active agent by weight in water.

32. The method of claim 30 wherein said surface active agent comprises at least one surfactant from the group consisting of poly (oxyethylene-co-oxypropylene)block polymer, ethylene oxide-propylene oxide-ethylene oxide triblock copolymer, N-oleyl-N-methyl taurate, and di-isooctylsulphosuccinate.

33. The method of claim 30 wherein said contacting said medical implement in said aqueous dispersion comprises dipping said medical implement into said aqueous dispersion.

34. The method of claim 30 wherein said sulfonated polyester comprises a sulfonated poly(alkylene phthalate).

35. The method of claim 30 wherein said sulfonated polyester comprises a polymeric compound having the structure

36. The method of claim 30 wherein said sulfonated polyester comprises a sulfonated poly(ethylene isophthalate).

37. The method of claim 30 wherein said sulfonated polyester comprises poly(ethylene 4-sodiosulfenyl isophthalate).

38. The method of claim 30 wherein drying said medical implement comprises;

heating the coated medical implement at approximately about 60°

C. to about 120°

C.

39. The method of claim 30 wherein said medical implement is a lancing implement.

40. The method of claim 30 wherein the medical implement is a microneedle.

46. The method of claim 30, wherein said providing said aqueous dispersion comprises providing a composition comprising:

(a) between approximately 0.5% and approximately 30% of sulfonated polyester by weight;

(b) between approximately 0.1% and approximately 5% of surface active agent by weight; and

(c) between approximately 65% and approximately 99.4% of water by weight.

41. A method for acquiring a sample of bodily fluid from a patient, comprising;

(a) coating a needle with a composition comprising a sulfonated polyester;

(b) penetrating said needle into said patient; and

(c) drawing said bodily fluid through said needle.

42. The method of claim 41 wherein said sulfonated polyester comprises a sulfonated poly(alkylene phthalate).

43. The method of claim 42 wherein said sulfonated polyester comprises a polymeric compound having the structure

44. The method of claim 42 wherein said sulfonated polyester comprises a sulfonated poly(ethylene isophthalate).

45. The method of claim 42 wherein said sulfonated polyester comprises poly(ethylene 4-sodiosulfenyl isophthalate).

47. The method of claim 42 wherein drying said medical implement comprises;

heating the coated medical implement at approximately about 60°

C. to about 120°

C.

48. The method of claim 42 wherein said medical implement comprises a lancing implement.

49. The method of claim 48 wherein said lancing comprises a microneedle.

51. The method of claim 41 further comprising coating said needle with a surface active agent in the presence of said sulfonated polyester.

50. A method for acquiring a sample of bodily fluid from a patient, comprising;

(a) coating a needle with a composition comprising a sulfonated polyester;

(b) penetrating said needle into said patient; and

(c) drawing said bodily fluid through said needle.

52. The method of claim 50, further comprising drying said needle to provide a solid coating thereon.

53. The method of claim 52 wherein said drying comprises heating said needle to a temperature of approximately about 60°

C. and approximately 120°

C.

54. The method of claim 50, wherein said coating is carried out using a composition comprising:

(a) between approximately 0.5% and approximately 30% of sulfonated polyester by weight;

(b) between approximately 0.1% and approximately 5% of surface active agent by weight; and

(c) between approximately 65% and approximately 99.4% of water by weight.

55. The method of claim 54, wherein said coating comprises dipping said needle in said composition.

56. The method of claim 52, wherein said solid coating comprises between approximately 80% and approximately 98% weight of said sulfonated polyester, and between approximately 20% and approximately 2% by weight of surface active agent.

57. The method of claim 56 wherein said sulfonated polyester comprises a sulfonated poly(alkylene phthalate).

58. The method of claim 57 wherein said sulfonated polyester comprises a sulfonated poly(ethylene isophthalate).

59. The method of claim 58 wherein said sulfonated polyester comprises poly(ethylene 4-sodiosulfenyl isophthalate).

60. A medical implement, comprising a needle having a coating thereon comprising a sulfonated polyester.

61. The medical implement of claim 60, wherein said coating comprises of between approximately 80% and approximately 98% weight of said sulfonated polyester, and between approximately 20% and approximately 2% by weight of surface active agent.

62. The medical implement of claim 61 wherein said sulfonated polyester comprises a sulfonated poly(alkylene phthalate).

63. The medical implement of claim 62 wherein said sulfonated polyester comprises a sulfonated poly(ethylene isophthalate).

64. The medical implement of claim 63 wherein said sulfonated polyester comprises poly(ethylene 4-sodiosulfenyl isophthalate).

65. A kit for drawing a sample of a bodily fluid, comprising the medical implement of claim 61, and a test strip configured to receive said sample of bodily fluid.