MEDICAL FLUID ACCESS DEVICE WITH ANTISEPTIC INDICATOR

• US 20080021381A1
• Filed: 07/20/2007
• Published: 01/24/2008
• Est. Priority Date: 07/20/2006
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: HOERLE, William S., LURVEY, Kent L., KRONGAUZ, Vadim V., HAI, Ton That, NORDHAUS, Mark A., CLARKE, Robert A., WOO, Lecon L., SANDFORD, Craig L., KIRICHKOW, Nicklaus J., YEH, Rosa H., SAVITSKI, Alexander, LAL, Birendra K., YANG, Hsinjin E., PAULEY, Robin G., STERNBERG, Shmuel, SUH, Kenneth Glen, LING, Michael Tung-Kiung, KRISHNAMOORTHY, Sivaramakrishnan, KHANNA, Ashok K., CAWTHON, Dustin C.
• Granted Patent: US 7,981,381 B2
• Time in Patent Office: Days
• US Class Current: 604/85
• 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

A medical device, such as a vascular access device, 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, comprising:

an access site for the introduction or withdrawal of medical fluids; and

an antiseptic indicator comprising a porous surface of a polymer at the access site, the antiseptic indicator configured to change from a first appearance to a second appearance upon exposure to an antiseptic agent, and wherein the antiseptic indicator substantially resumes the first appearance after a period of time.

2. The access device of claim 1, including a housing and a valve member, the antiseptic indicator attached to at least one of the housing and the valve member.

3. The access device of claim 1, wherein the antiseptic indicator includes a surface layer including a plurality of polymer particles on the surface layer, the polymer particles having an appearance of a plurality of fine, small cracks or crazes on the porous surface.

4. The access device of claim 1, wherein the antiseptic indicator includes a surface layer including a plurality of fine, small cracks or crazes on the porous surface.

5. The access device of claim 1, wherein the antiseptic indicator includes a surface layer including a micropattern configured to selectively reflect one or more wavelengths of light.

6. The access device of claim 5, wherein the micropattern includes a plurality of grooves and ridges having a groove spacing between about 0.1 μ

m and about 0.7 μ

m.

7. The access device of claim 1, wherein the polymer from which the porous surface is made has an index of refraction between about 1.25 and 1.6, the porous surface configured to have a substantially opaque state in the first appearance and a transparent state in the second appearance.

8. The access device of claim 1, wherein the porous surface comprises a membrane configured to be substantially resistant to blood staining.

9. The access device of claim 1, wherein porous surface comprises a membrane, the membrane including a morphology having particle-like structures.

10. The access device of claim 1, wherein the porous surface comprises a plurality of polymer particles.

11. The access device of claim 1, wherein the antiseptic indicator includes a layer of luminescent material configured to emit light, the porous surface disposed on the layer of luminescent material, wherein the porous surface is configured to obscure emitted light in the first appearance, and wherein the porous surface is configured so that the emitted light is visible through the porous surface in the second appearance.

12. The access device of claim 1, wherein the porous surface is attached to the access site by an adhesive including a color, wherein the porous surface is configured to obscure the color in the first appearance, and wherein the porous surface is configured so that the color is visible through the porous surface in the second appearance.

13. The access device of claim 1, wherein the antiseptic indicator is configured to have a non-luminescent state in the first appearance and a luminescent state in the second appearance.

14. The access device of claim 1, wherein the antiseptic indicator includes a dye configured to have a first color in the first appearance and a second color in the second appearance.

15. The access device of claim 14, wherein the dye includes a compound having the structure

16. The access device of claim 1, wherein the polymer from which the porous surface is made has an index of refraction from about 1.25 to about 1.6, and further comprising a solvatochromatic dye or a salt or derivative thereof, in an amount from about 0.1% to about 0.5%, wherein the dye has a first color in the first appearance and a second color in the second appearance.

17. The access device of claim 14, wherein the dye is a merocyanine dye or a salt or derivative thereof, or Reichardt'"'"'s dye or a salt or a derivative thereof.

18. The medical device of claim 1, wherein the polymer is at least one of acrylic, COC, nylon, methacrylic, elastomer, polycarbonate, polyurethane, epoxy, polyester, and vinylester.

19. The access device of claim 1, wherein the porous surface comprises a membrane made from a polymeric material having an index of refraction from about 1.25 to about 1.6, and further comprising a coating with a solvatochromic dye applied to the membrane in an amount effective to visually detect a change of the dye from a first color in the first appearance to a second color in the second appearance.

20. The access device of claim 1, wherein the antiseptic indicator is affixed to the access site by one of solvent bonding, adhesive bonding, sonic welding, melding, molding, laser welding and chemical bonding.

21. The access device of claim 1, further comprising a protective member atop the antiseptic indicator and configured to protect the antiseptic indicator.

22. The access device of claim 1, wherein the porous surface is a surface of the access site.

23. A medical fluid access device, comprising:

a housing and a valve member defining a fluid access site for introduction and withdrawal of fluids; and

a polymeric porous indicator disposed at the access site, the indicator including a dye that is configured to change from a first color to a second color upon exposure to an antiseptic solution, and wherein the dye is configured to resume the first color after a period of time.

24. The access device of claim 23, wherein the dye is a solvatochromic dye.

25. The access device of claim 24, wherein the dye is a merocyanine dye or a salt or derivative thereof, or Reichardt'"'"'s dye or a salt or derivative thereof.

26. The access device of claim 23, wherein the dye comprises a compound having the structure:

27. The access device of claim 26, wherein if R1 is acryloyl, the derivatives comprise ammonium hydroxide, alkali and alkaline earth salts, and mixtures thereof, and if R1 is hydrogen, the derivatives comprise a hydrobromide, hydrochloride, hydrofluoride, phosphate, sulfate, and mixtures thereof.

28. The access device of claim 26, wherein R1 is hydrogen, R2 is n-hexyl, R4 and R6 are chloride, R5 is hydrogen, and R7 is O⁻

.

31. The access device of claim 23, wherein the polymer is at least one of acrylic, COC, nylon, methacrylic, elastomer, polycarbonate, polyurethane, epoxy, polyester, and vinylester.

32. The access device of claim 23, wherein the porous polymeric indicator comprises a membrane made from a polymer having an index of refraction from about 1.25 to about 1.6, and further comprising a coating containing the dye.

33. The access device of claim 23, wherein the dye is chemically bonded to the access site.

29. The access device of 23, wherein the indicator is alcohol permeable and the polymer from which the indicator is made has an index of refraction from about 1.25 to about 1.6.

30. The access device of 23, wherein the indicator further comprises a solvatochromic dye or a salt or a derivative thereof in an amount from about 0.1% to about 0.5% of the weight of the material.

34. An antiseptic indicator, comprising:

a substrate; and

a microporous layer disposed on the substrate, the microporous layer made from a polymer material having an index of refraction from about 1.25 to about 1.6 and configured to change from a substantially opaque state to a transparent state upon exposure to an antiseptic solution, and wherein the microporous layer resumes the substantially opaque state after a period of time.

35. The indicator of claim 34, wherein the microporous layer comprises a membrane configured to be resistant to blood staining.

36. The indicator of claim 34, wherein the microporous layer comprises a membrane having a morphology with particle-like structures.

37. The indicator of claim 34, wherein the microporous layer is a membrane made by a liquid/liquid phase separation process.

38. The indicator of claim 34, wherein the polymer material is selected from the group consisting of polyvinylidene fluoride, 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.

39. The indicator of claim 34, wherein the microporous polymer material includes a plurality of porous polymer particles.

40. The indicator of claim 39 wherein the porous polymer particles are selected from the group consisting of polyhexafluoropropyleneoxide (PHFPO);

alginic acid, the sodium salt of alginic acid, and derivatives thereof;

hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxymethyl cellulose, cellulose acetate butyrate, cellulose acetate, and cellulose derivatives;

polytetrafluoroethylene (PTFE);

e-PTFE (expanded PTFE);

fluorinated ethylene propylene (FEP);

perfluoroalkoxy polymer (PFA);

ethylene-tetrafluoroethylene (ETFE);

polyvinylidenefluoride (PVDF);

polychlorotrifluoroethylene (PCTFE);

poly(methylhydrosiloxane);

polydimethysiloxane;

acrylic and methacrylic acid, salts and derivatives thereof; and

THV.

41. The indicator of claim 34, further comprising a luminescent material between the substrate and the microporous layer, the luminescent material configured to emit light, wherein the microporous layer is configured to obscure the emitted light while in the substantially opaque state and to transmit the emitted light therethrough while in the transparent state.

42. The indicator of claim 41, wherein the luminescent material is selected from the group consisting of photoluminescent compounds and chemiluminescent compounds.

43. The indicator of claim 41, wherein the luminescent material comprises two containers with a first solution and a second solution that are mixed to emit light when swabbed with the antiseptic solution.

44. The indicator of claim 34, wherein the substrate includes an adhesive having a color, wherein the microporous layer is configured to obscure the color while in the substantially opaque state, and wherein the microporous layer is configured so that the color is visible through the microporous layer in the transparent state.

45. A medical device, comprising:

a medical device having a surface; and

an indicator atop the surface, the indicator comprising an optically active, surface layer that is configured to change from a first appearance to a second appearance upon exposure to an antiseptic solution, and wherein the indicator substantially resumes the first appearance after a period of time.

46. The medical device of claim 45, wherein the indicator comprises a polymer.

47. The medical device of claim 45 wherein the medical device is selected from the group consisting of catheters, drug vial spikes, connectors, vascular access devices, luer access devices, access ports, medication ports, pigtail connectors, prosthetics, endoscopes, bronchoscopes, stethoscopes, and infusion pumps.

48. The medical device of claim 45, wherein the indicator comprises a plurality of polymer particles on the surface layer having an appearance of a plurality of fine, small cracks or crazes on the surface layer surface.

49. The medical device of claim 45, wherein the indicator comprises a transparent porous thin film attached to the surface of the medical device, and the optically active surface layer is a surface of the thin film.

50. The medical device of claim 45, wherein the optically active surface layer is substantially opaque in the first appearance and transparent in the second appearance.

51. The medical device of claim 45, wherein the optically active surface layer includes a plurality of fine, small cracks on the surface layer.

52. The medical device of claim 45, wherein the surface layer is made from a polymer material having an index of refraction from about 1.25 to about 1.6.

53. The medical device of claim 45, wherein the optically active surface layer includes a micropattern configured to selectively reflect one or more wavelengths of light.

54. The medical device of claim 53, wherein the micropattern includes parallel grooves and ridges having a groove spacing between about 0.1 μ

m to about 0.7 μ

m.

55. The medical device of claim 53, wherein the micropattern is configured to display an image in the first appearance and the image appears to disappear in the second appearance.

56. The medical device of claim 45, wherein the indicator is a portion of the surface of the medical device.

57. A medical device, comprising:

a medical device having a surface; and

an antiseptic indicator comprising a micropattern including a plurality of grooves and ridges, having a groove spacing from about 0.1 μ

m to about 0.7 μ

m on the surface, the antiseptic indicator configured to change from a first appearance to a second appearance upon exposure to an antiseptic solution, and wherein the antiseptic indicator substantially resumes the first appearance after a period of time.

58. The medical device of claim 57, wherein the device is selected from the group consisting of catheters, drug vial spikes, connectors, vascular access devices, luer access devices, access ports, medication ports, pigtail connectors, prosthetics, endoscopes, bronchoscopes, stethoscopes, and infusion pumps.