MEDICAL FLUID ACCESS SITE WITH ANTISEPTIC INDICATOR

• US 20080107564A1
• Filed: 10/18/2006
• Published: 05/08/2008
• Est. Priority Date: 07/20/2006
• Status: Abandoned Application

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Ling, Michael Tung-Kiung, Lal, Birendra K., Hai, Ton That, Cawthon, Dustin C., Lurvey, Kent L., Khanna, Ashok K., Sandford, Craig L., Yeh, Rosa H., Hoerle, William S., Krongauz, Vadim V., Sternberg, Shmuel, Pauley, Robin G., Woo, Lecon
• Application Number:
  US11/550,643
• Publication Number:
  US 20080107564A1
• Time in Patent Office: Days
• US Class Current: 422/55
• CPC Class Codes: A61M 2039/1033 Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
• CPC Class Codes: A61M 2039/1072 with a septum present in the connector
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/16 having provision for disinfection or sterilisation A61M39/143 takes precedence; methods or apparatus for disinfection or sterilisation A61L2/00
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 31/22 using chemical indicators G01N31/02 takes precedence

Abstract

An access device including access site is disclosed for providing access to a medical fluid flow path for the introduction or withdrawal of medical fluids to and from the flow path. The access device includes an indicator for providing a visual indication when the access device has been exposed to an antiseptic agent.

Claims

1. A medical fluid access device including an exposure indicator for indicating exposure to an antiseptic agent, the access device comprising:

a housing defining an access site for the introduction or withdrawal of medical fluid through the housing,

a material disposed on the housing for providing a visual indication of exposure to an antiseptic agent, the material comprising a dye that is responsive to exposure to an antiseptic agent to visually indicate such exposure.

2. The medical fluid access device of claim 1 wherein the material comprises a salt.

3. The medical fluid access device of claim 1 wherein the material comprises a solvent-absorbing polymer matrix material.

4. The medical fluid access device of claim 1 wherein the material is bonded to the housing by decorative molding.

5. The medical fluid access device of claim 1 wherein the material maintains the visual indication of exposure for a selected period of time after exposure.

6. The medical fluid access device of claim 1 wherein the visual indication comprises a change in color of the dye.

7. The medical fluid access device of claim 1 wherein the visual indication is for a limited time duration.

8. The medical fluid access device of claim 1 wherein said material comprises a salt and an acid.

9. The medical fluid access device of claim 1 wherein said dye is incorporated in a hydrogel material.

10. A medical fluid access device in accordance with claim 1 wherein the material comprises a salt of Nile Red and poly(acrylic acid) incorporated in a crosslinked antiseptic solvent-absorbing polymeric material.

11. An exposure indicator for indicating exposure to an antiseptic agent comprising:

a substrate and a membrane carried on the substrate, the membrane providing a visual indication of exposure of the membrane to an antiseptic agent.

12. The exposure indicator of claim 11 wherein the membrane comprises a microporous membrane.

13. The exposure indicator of claim 11 wherein the membrane comprises an ultrafiltration membrane.

14. The exposure indicator of claim 11 wherein the visual indication comprises a color change.

15. The exposure indicator of claim 11 wherein the visual indication is for a limited time duration.

16. The exposure indicator of claim 11 wherein the membrane carries a dye that is responsive to exposure to an antiseptic agent to provide a visual indication of such exposure.

17. The exposure indicator of claim 16 wherein the dye is incorporated in the membrane.

18. The exposure indicator of claim 11 wherein the membrane has an original apparent color before exposure to an antiseptic agent, changes apparent color upon exposure to an antiseptic agent, and returns substantially to the original color thereafter.

19. The exposure indicator of claim 11 wherein the visual indication also indicates one of a degree of exposure to an antiseptic agent, the amount of swabbing motion of the antiseptic agent, and the pressure and control of the swabbing of the antiseptic agent.

20. The exposure indicator of claim 11 wherein the membrane is solid or porous.

21. An exposure indicator for indicating exposure to an antiseptic agent comprising:

a substrate

a membrane carried on the substrate,

an indicator incorporated in the membrane and adapted to provide a visual indication of exposure of the membrane to an antiseptic agent.

22. The exposure indicator of claim 21 wherein the membrane comprises a microporous membrane.

23. The exposure indicator of claim 21 wherein the membrane comprises an ultrafiltration membrane.

24. The exposure indicator of claim 21 wherein the visual indication comprises a color change.

25. The exposure indicator of claim 21 wherein the indicator indicates a degree of exposure to an antiseptic agent.

26. The exposure indicator of claim 24 wherein the degree of color change is indicative of the degree of exposure to an antiseptic agent.

27. The exposure indicator of claim 21 wherein the visual indicator is for a limited time duration.

28. The exposure indicator of claim 21 wherein the indicator comprises a dye impregnated in the membrane.

29. The exposure indicator of claim 21 wherein the indicator comprises a dye encapsulated in a solvent-absorbent polymer.

30. The exposure indicator of claim 29 wherein the solvent-absorbent polymer comprises a crosslinked polymer.

31. The exposure indicator of claim 21 wherein the solvent-absorbent polymer comprises a hydrogel.

32. The exposure indicator of claim 21 wherein the indicator has an original apparent color before exposure to an antiseptic agent, changes apparent color upon exposure to an antiseptic agent, and returns substantially to the original color thereafter.

33. An exposure indicator for indicating exposure to an antiseptic agent comprising:

a substrate,

an indicator material carried on the substrate, the indicator material being responsive by visible change upon exposure to the antiseptic agent, and

a membrane disposed over the indicator material.

34. The exposure indicator of claim 33 wherein the indicator material comprises a dye.

35. The exposure indicator of claim 33 wherein the indicator material comprises a salt.

36. The exposure indicator of claim 33 wherein the indicator material is incorporated in a solvent-absorbent polymer.

37. The exposure indicator of claim 33 wherein the indicator material comprises an acid.

38. The exposure indicator of claim 33 wherein the indicator material comprises a salt of an acid.

39. The exposure indicator of claim 33 wherein the visible change comprises a color change.

40. The exposure indicator of claim 39 wherein the color change is for a limited time duration.

41. The exposure indicator of claim 39 wherein the indicator material has an original apparent color before exposure to an antiseptic agent, changes apparent color upon exposure to an antiseptic agent, and returns substantially to the original color thereafter.

42. The exposure indicator of claim 33 wherein the indicator material indicates a degree of exposure to an antiseptic agent.

43. The exposure indicator of claim 39 wherein the degree of color change is indicative of the degree of contact with an antiseptic agent

44. The exposure indicator of claim 33 wherein the substrate comprises a polycarbonate.

45. The exposure indicator of claim 33 wherein the indicator material is affixed to the housing by one of solvent bonding, adhesive, glue, and sonic welding.

46. The exposure indicator of claim 33 wherein the membrane is porous.

47. The exposure indicator of claim 33 wherein the membrane controls the one of the rate of evaporation and ingress of the antiseptic agent from the indicator material after contact therewith.

48. An exposure indicator for indicating exposure to an antiseptic agent comprising:

a substrate,

a indicator material disposed on the substrate, the indicator comprising a substantially non-transparent material, said material being responsive by a change in transparency upon exposure to an antiseptic agent.

49. The exposure indicator of claim 48 wherein the substrate comprises a medical fluid access device housing.

50. The exposure indicator of claim 48 wherein the substrate is selected from the group consisting of polyester, polyvinyl chloride, polypropylene, polyethylene, cellulose acetate, ethylene vinyl acetate, cyclic olefin copolymer, PET-polyethylenetetraflouride, PU-polyurathane, nylon, and polyacrylamide.

51. The exposure indicator of claim 48 wherein the indicator is selected from the group consisting of polytetrafluoroethylene, ethylene tetrafluoroethylene, polychlorotrifluoroethylene, polydimethyl siloxane, polyvinylidene fluoride, polyvinyl acetate, cellulose acetate, ethylene vinyl acetate copolymer, poly methyl methacrylate, polypropylene, polyethylene, polyacrylic acid, polyvinyl chloride, and polycarbonate.

52. The exposure indicator of claim 48 wherein the indicator material is affixed to the substrate.

53. The exposure indicator of claim 48 wherein the indicator material is affixed to the substrate by one of laser welding, adhesive, and ultrasonic welding.

54. The exposure indicator of claim 48 wherein the substrate comprises a medical fluid access device housing and an adhesive bonding the indicator to the housing.

55. The exposure indicator of claim 48 wherein the substrate is affixed to a medical fluid flow control device housing by one of laser welding, adhesive, and ultrasonic welding.

56. The exposure indicator of claim 48 wherein the indicator material changes from substantially non-transparent to at least partially transparent upon exposure to an antiseptic agent.

57. The exposure indicator of claim 56 wherein the indicator material includes a visible pattern in the substantially non-transparent state, and wherein the pattern becomes substantially invisible when the indicator material is contacted by an antiseptic agent.

58. The exposure indicator of claim 56 wherein the change in transparency is for a limited time duration.

59. The exposure indicator of claim 56 wherein the indicator further includes a visual signal source that becomes visible upon a change in transparency when the indicator material is contacted by an antiseptic agent.

60. The exposure indicator of claim 59 wherein the visual signal source is selected from a group consisting of a color, a text message, and an icon.

61. The exposure indicator of claim 48, wherein the indicator material comprises a microporous structure and has a refractive index that is substantially different from the refractive index of air.

62. The exposure indicator of claim 61 wherein the refractive index of the indicator material is closer to the refractive index of the antiseptic agent than it is to the refractive index of air.

63. An exposure indicator for indicating exposure to an antiseptic agent comprising:

a substrate,

an indicator disposed on the substrate, said indicator comprising a substantially non-transparent material, said material being responsive by a change in transparency upon exposure to the antiseptic agent

a permeable membrane disposed over the indicator.

64. The exposure indicator of claim 63 wherein the substrate comprises an adhesive layer.

65. The exposure indicator of claim 63 wherein the indicator comprises a porous material.

66. The exposure indicator of claim 63 wherein the permeable membrane comprises a porous material.

67. The exposure indicator of claim 65 wherein the pore size of the indicator is different than the pore size of the permeable membrane.

68. The exposure indicator of claim 63 wherein the substrate is selected from the group consisting of polyester, polyvinyl chloride, polypropylene, polyethylene, cellulose acetate, ethylene vinyl acetate, cyclic olefin copolymer, polyethyleneterathalate, polyurethane, nylon, and polyacrylamide.

69. The exposure indicator of claim 63 wherein the indicator is selected from the group consisting of polytetrafluoroethylene, ethylene tetrafluoroethylene, polychlorotrifluoroethylene, polydimethyl siloxane, polyvinylidene fluoride, polyvinyl acetate, cellulose acetate, ethylene vinyl acetate copolymer, poly methyl methacrylate, polypropylene, polyethylene, polyacrylic acid, polyvinyl chloride, and polycarbonate.

70. The exposure indicator of claim 63 wherein the indicator changes from substantially non-transparent to at least partially transparent.

71. The exposure indicator of claim 63 wherein the indicator includes a visible pattern in the substantially non-transparent state, and wherein the pattern becomes substantially invisible when the indicator is contacted by an antiseptic agent.

72. The exposure indicator of claim 70 wherein the change in transparency is for a limited time duration.

73. The exposure indicator of claim 70 wherein the indicator further includes a visual signal source that becomes visible upon a change in transparency when the indicator is contacted by an antiseptic agent.

74. The exposure indicator of claim 73 wherein the visual signal source is selected from a group consisting of a color, a text message, and an icon.

75. The exposure indicator of claim 63 wherein the indicator includes a second substrate, the second substrate being attached to the substrate and material and comprising a double sided adhesive tape.