UNIVERSAL STERILIZING TOOL

• US 20100172794A1
• Filed: 09/18/2008
• Published: 07/08/2010
• Est. Priority Date: 05/06/2008
• Status: Active Grant

• Current Assignee: 1Worldvista Medical, Inc.
• Original Assignee: Michael J. Ferlic
• Inventors: Ferlic, Michael J., Powley, Nicholas, Ferlic, Mason J., Ferlic, Charlotte P.
• Granted Patent: US 8,273,303 B2
• Time in Patent Office: Days
• US Class Current: 422/28
• CPC Class Codes: A61L 2/238 Metals or alloys, e.g. oligodynamic metals
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2202/17 Combination with washing or cleaning means
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• 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

Abstract

A contoured sterilizing element is configured to conform to the outer and inner surfaces of a working end-site of a medical device such as a catheter hub, luer connector, luer component, needleless access site, and/or access port The sterilizing element is made from absorbent material and can be pre-moistened or impregnated with an anti-pathogenic agent The sterilizing element can be contained within a housing that is easily griped and opened in one hand by the user The sterilizing element is configured to wipe debris from and to sterilize and/or dry a working end-site of medical device, using a wiping, twisting, dabbing, push/pull, and/or screwing motion around all of the surface aspects of the device to be sterilized

Claims

1. A universal contoured sterilizing element for wiping and sterilizing surfaces of a working end-site of a medical device, the contoured sterilizing element comprising:

a resilient article comprising a material impregnated with an anti-pathogenic agent, the resilient article including a first end, a second end, an outer exterior, and a recessed cavity configured to receive the working end-site of the medical devices therein, the recessed cavity comprising of an inner surface shaped to contour to and contact an outer surface of the working end-site of the medical device and a raised base portion shaped to contour and contact an inner surface of the working end-site of the medical device.

2. The contoured sterilizing element according to claim 1, wherein the sterilizing element is disposable after a single wiping and sterilizing application.

3. The contoured sterilizing element according to claim 1, wherein a friction fit is created between the working end-site of the medical device and the recessed cavity of the sterilizing element such that the sterilizing element engages the working end-site of the medical device and is retained on the working end-site until ready for use.

4. The contoured sterilizing element according to claim 1, wherein the medical device further comprises a shroud defining inner surfaces, and wherein the outer exterior of the sterilizing element is configured to contour and contact the inner surfaces of the shroud such that a friction fit is created between the inner surfaces of the shroud and the outer exterior of the sterilizing element such that the sterilizing element engages the working end-site of the medical device and is retained on the working end site until ready for use.

6. The contoured sterilizing element according to claim 1, wherein the impregnated material comprises any one of a viscoelastic, resilient material or a particulate-free absorbent material.

7. The contoured sterilizing element according to claim 1, wherein the impregnated material is pre-moistened with the anti-pathogenic agent.

8. The contoured sterilizing element according to claim 1, wherein the anti-pathogenic agent comprises a dry agent bonded to the material such that the dry agent impregnates the material.

9. The contoured sterilizing element according to claim 1, wherein the anti-pathogenic agent comprises an oligodynamic metal.

10. The contoured sterilizing element according to claim 1, wherein the anti-pathogenic agent comprises any one of an antiseptic, antibacterial, anti-viral, microbiocidal, disinfectant, or a combination thereof.

11. The contoured sterilizing element according to claim 1, wherein the recessed cavity further comprises a plurality of raised contouring structures on the inner surface of the recessed cavity.

12. The contoured sterilizing element according to claim 11, wherein the plurality of contouring raised structures comprises any one of ridges, ribs, flanges, steps, threads, or combinations thereof.

13. The contoured sterilizing element according to claim 1, wherein the recessed cavity comprises an inner diameter smaller than an outer diameter of the working end-site to be sterilized, wherein the recessed cavity contours to and contacts the outer and inner surfaces of the working end-site to be sterilized.

15. The contoured sterilizing element according to claim 1, wherein the material comprises a shaped, molded, die cut, or sculpted impregnated material.

16. The contoured sterilizing element according to claim 1, further comprising a housing having at least one end adapted to be opened, wherein the sterilizing element is contained and secured within the housing, the at least one end comprising a frangible lid and a protective cover secured adjacent to the frangible lid.

17. The contoured sterilizing element according to claim 1, further comprising a housing having at least one end adapted to be opened, wherein the sterilizing element is contained and secured within the housing.

18. The contoured sterilizing element according to claim 17, wherein the at least one end of the housing is adapted to be opened comprises a frangible lid, wherein the working end-site of the medical device is forcibly engaged through the frangible lid to access the sterilizing element contained within the housing.

19. The contoured sterilizing element according to claim 17, wherein the at least one end of the housing comprises a lid comprising a frangible foil, a frangible material, or a frangible laminated material.

20. The contoured sterilizing element according to claim 17, wherein the at least one end of the housing comprises a frangible pre-scored lid.

21. The contoured sterilizing element according to claim 1, wherein the outer exterior of the sterilizing element further comprises a plurality of raised contouring structures.

22. The contoured sterilizing element according to claim 21, wherein the plurality of raised contouring structures can be selected from any one of ridges, ribs, flanges, steps, threads, or combinations thereof.

86. The contoured sterilizing element according to claim 1, wherein the medical device comprises a lumen and wherein the raised base portion is sculpted to be inserted into and contoured to an inner surface of the lumen such that the inner lumen is contacted with the anti-pathogenic agent.

87. The contoured sterilizing element according to claim 1, wherein the contoured sterilizing element is a universal sterilizing element and is sculpted to contour and contour to and to engage the working end site of any one of a luer hub, a male luer, a female luer, a slip luer, a luer compatible component, lumen, a needle access port, a needleless connector, catheter connector end, medical device end site or septum.

5. (canceled)

14. (canceled)

23. A sterilizing element for wiping and sterilizing outer and inner surfaces of a working end-site of a medical device, the sterilizing element comprising:

an impregnated article comprising an anti-pathogenic agent, the impregnated article including a first end and a second end, an outer wall, and a recessed portion configured to inwardly receive the working end-site of the medical device, the recessed portion comprising an inner diameter that tapers down from the first end to the second end of the sterilizing element, a base portion shaped to contour and contact an end of the working end-site, and an inner surface sculpted to contour and contact and form-fit to the outer surfaces of the working end-site of the medical device.

24. The sterilizing element according to claim 23, wherein the base portion is a raised base portion shaped and sculpted to contour and contact the end and the inner surfaces of the working end-site of the medical device for sterilization.

25. The sterilizing element according to claim 24, wherein the raised base portion is contoured and comprises any one of a nipple, a nub, a bump, a tine, or other projection.

26. The sterilizing element according to claim 23, wherein the recessed portion further comprises a plurality of raised contouring structures on the inner surface.

27. The sterilizing element according to claim 26, wherein the plurality of raised contouring structures comprises any one of ridges, flanges, steps, threads, or combinations thereof.

28. The sterilizing element according to claim 23, wherein the recessed portion further comprises an inner diameter smaller than an outer diameter of the working end-site of the medical device.

29. The sterilizing element according to claim 23, wherein the element is disposable after a single wiping and sterilizing application.

30. The sterilizing element according to claim 23, wherein a friction fit is created between the working end-site of the medical device and the sculpted and contoured inner surfaces of the recessed portion of the impregnated article such that the impregnated article engages the working end-site of the medical device and is retained thereon until ready for use.

32. The sterilizing element according to claim 23, wherein the impregnated article comprises any one of an absorbent material, a pre-moistened material, a particulate-free absorbent material, or a viscoelastic material.

33. The sterilizing element according to claim 23, wherein the impregnated article comprises a die-cut, shaped, molded, or sculpted material.

34. The sterilizing element according to claim 23, wherein the anti-pathogenic agent comprises any one of an antiseptic, antibacterial, anti-viral, microbiocidal, disinfectant, an oligodynamic metal or a combination thereof.

35. The sterilizing element according to claim 23, further comprising a housing having at least one end adapted to be opened, wherein the sterilizing element is contained and secured within the housing.

36. The sterilizing element according to claim 35, wherein the at least one end adapted to be opened comprises a frangible lid, wherein the working end-site of the medical device is forcibly engaged through the frangible lid to access the sterilizing element contained within the housing.

37. The sterilizing element according to claim 23, further comprising a housing having at least one end adapted to be opened, wherein the sterilizing element is contained and secured within the housing, the at least one end comprising a frangible lid and a protective cover secured adjacent to the frangible lid.

38. The sterilizing element according to claim 23, wherein the outer wall is shaped and sculpted to contour and contact an inner surface of a medical device shroud.

39. The sterilizing element according to claim 23, wherein the outer wall of the impregnated article comprises a plurality of raised contouring structures, wherein the plurality of raised contouring structures can be selected from any one of ridges, ribs, flanges, steps, threads, or combinations thereof.

40. The sterilizing element according to claim 38, wherein the medical device further comprises a shroud defining an inner cavity having inner surfaces and wherein the outer wall of the sterilizing element is shaped and sculpted to contour and contact the inner surface of the shroud such that a friction fit is created between the inner surface of the shroud and the outer wall of the sterilizing element such that the sterilizing element engages the working end-site of the medical device and is retained on the working end site until ready for use.

88. The sterilizing element according to claim 23, wherein the medical device comprises a lumen and wherein the base portion is a raised base portion and is shaped and sculpted to be inserted into and contoured to an inner surface of the lumen such that the inner lumen is contacted with the anti-pathogenic agent.

89. The sterilizing element according to claim 23, wherein the contoured sterilizing element is a universal sterilizing element and is sculpted to contour and contour to and to engage the working end site of any one of a luer hub, a male luer, a female luer, a slip luer, a luer compatible component, lumen, a needle access port, a needleless connector, catheter connector end, medical device end site or septum.

31. (canceled)

41. A universal contoured sterilizing element for wiping and sterilizing outer and inner surfaces of a working end-site of a medical device comprising a resilient article impregnated with an anti-pathogenic agent, the resilient article shaped and sculpted to contour and to contact the outer and inner surfaces of the working end-site of the medical device.

42. A sterilizing device for wiping and sterilizing outer and inner surfaces of a working end-site of a medical device, the sterilizing device comprising:

a housing device comprising, at least one end adapted to be opened, and sidewalls having outer walls; and

a sterilizing element contained and secured within the housing, the sterilizing element comprising;

a first end and a second end, and a recessed cavity configured to receive and engage the outer surfaces of the working end-site, the recessed cavity having an inner surface shaped and sculpted to contour to and contact the outer surfaces of the working end-site and a raised base portion shaped to contour and contact the inner surfaces of the working end-site, wherein the sterilizing element is impregnated with an anti-pathogenic agent.

43. The device according to claim 42, wherein the at least one end adapted to be opened comprises a seal adapted to be transitioned from a closed configuration to an open configuration by the application of an inward pressure applied to the sidewalls of the housing.

44. The device according to claim 42, wherein the at least one end adapted to be opened comprises a lid adapted to be removed from the housing by the application of an inward pressure applied to the sidewalls of the housing.

45. The device according to claim 42, wherein the at least one end comprises a peel-away lid.

46. The device according to claim 42, wherein the housing comprises an envelope of a flexible material and wherein the at least one end adapted to be opened comprises a reinforced opening adapted to be transitioned from a closed configuration by the application of an inward pressure applied to the sidewalls of the housing.

47. The device according to claim 42, wherein the housing comprises an envelope of a flexible material having a lining, the lining comprising the sterilizing element.

48. The device according to claim 42, wherein the at least one end adapted to be opened comprises a frangible lid.

49. The device according to claim 42, wherein the at least one end adapted to be opened comprises a pre-scored lid.

50. The device according to claim 42, further comprising a protective cover secured adjacent to the at least one end adapted to be opened.

51. The device according to claim 42, wherein the housing further comprises a removable cover attached to a top portion of the housing by a tear line.

52. The device according to claim 42, wherein the housing further comprises a removable cover secured over the at least one end adapted to be opened.

53. The device according to claim 42, wherein the removable cover includes a second sterilizing element contained and secured within the removable cover, the second sterilizing element comprising:

an anti-pathogenic agent, a first end and a second end, and a recessed cavity configured to receive and contact the surfaces of the working end-site, the recessed cavity having an inner surface shaped to contour to and contact the outer surfaces of the working end-site and a raised base portion shaped to contour and contact the inner surfaces of the working end-site.

54. The device according to claim 42, wherein the device is disposable after a single use.

55. The device according to claim 42, wherein a friction fit is created between the working end-site of the medical device and the recessed cavity of the sterilizing element such that the device engages the working end-site of the medical device and is retained on the working end-site until ready for use.

56. The device according to claim 42, further comprising an outer exterior shaped and sculpted to contour and contact an inner surface of a medical device shroud.

57. The device according to claim 56, wherein outer exterior of the sterilizing element comprises a plurality of raised contouring structures, wherein the plurality of raised contouring structures can be selected from any one of ridges, ribs, flanges, steps, threads, or combinations thereof.

58. The contoured sterilizing element according to claim 56, wherein the medical device further comprises a shroud defining an inner cavity having inner surfaces and wherein the outer exterior of the sterilizing element is shaped and sculpted to contour and contact the inner surfaces of the shroud such that a friction fit is created between the inner surfaces of the shroud and the outer exterior of the sterilizing element such that the sterilizing element engages the working end-site of the medical device and is retained on the working end site until ready for use.

59. The device according to claim 42, wherein the housing comprises an ergonomic shape and is sized to be held and opened by a user'"'"'s fingers on one hand.

60. The device according to claim 42, wherein the housing is configured to opened single handedly.

61. The device according to claim 42, wherein the housing comprises at least one depression formed in the sidewalls for guiding placement of a user'"'"'s fingers.

62. The device according to claim 42, wherein the device can be engaged with the working end-site and retained on the working end-site until the device is removed for use of the working end-site.

63. The device according to claim 42, wherein the housing is sealed to maintain a level of moisture within the housing.

64. A sterilizing device comprising:

an elongated housing comprising a first portion having a first end adapted to be opened and a second portion having a second end adapted to be opened; and

a first sterilizing element contained and secured within the housing, the sterilizing element comprising an anti-pathogenic agent, at least one end configured to inwardly receive a working end-site a medical device therein, the at least one end shaped to contour and contact the surfaces of the working end-site, and an outer exterior shaped to contour and contact an inner surface of the medical device.

65. The sterilizing device according to claim 64, wherein the first sterilizing element comprises a single, continuous member extending from the first end of the first portion of the housing to the second end of the second portion of the housing, the continuous member comprising a first end and a second end, each end configured to inwardly receive the working end-site therein, and shaped and sculpted to contour to and contact the outer surfaces of the working end-site of the medical device and an outer exterior shaped and sculpted to contour and contact an inner surface of the medical device.

66. The sterilizing device according to claim 64, further comprising:

a partition separating the first portion of the housing from the second portion of the housing, wherein the first sterilizing element is secured within the first portion of the housing; and

a second sterilizing element contained and secured within the second portion of the housing, the second sterilizing element comprising an anti-pathogenic agent, at least one end configured to inwardly receive and shaped and sculpted to contour and contact at least an outer surface of the working end-site, and an outer exterior shaped to contour and contact an inner surface of the medical device.

67. The sterilizing device according to claim 64 further comprising:

a partition separating the first portion of the housing from the second portion of the housing, wherein the first sterilizing element is secured within the first portion of the housing; and

a drying element contained and secured within the second portion of the housing, the drying element is configured to inwardly receive and shaped and sculpted to contour and contact at least an outer surface of the working end-site.

68. The sterilizing device according to claim 64, further comprising:

a partition separating the first portion of the housing from the second portion of the housing, wherein the first sterilizing element is contained and secured within the first portion of the housing, the first end of the first portion of the housing adapted to be opened; and

a mating connector secured to the partition and contained within the second portion of the housing, the mating connector adapted to connect to any one of a male luer lock, slip luer, threaded luer, or connector end.

69. The sterilizing device according to claim 64, wherein at least the first end of the housing comprises a frangible lid.

70. A method of wiping and sterilizing a medical device including a working end-site having surfaces to be sterilized, the method comprising:

engaging a sterilizing element with the working end-site to be sterilized, the sterilizing element comprising an impregnated article including an anti-pathogenic agent, the impregnated article comprising a recessed cavity having an inner surface shaped and sculpted to contour and contact to form fit to an outer surface of the working end-site, a raised base portion shaped to contour and to contact an inner surface of the working end-site, and an outer exterior;

wiping and sterilizing the surfaces of working end-site;

disengaging the working end-site from the sterilizing element; and

air-drying the working end-site for a period of time such that the working end-site is dry prior to connection.

71. The method according to claim 70, further comprising disposing of the sterilizing element.

72. The method according to claim 70, wherein the step of wiping and sterilizing the working end-site comprises applying an inclusive layer of anti-pathogenic agent to the inner and outer surfaces of the working end-site.

73. The method according to claim 70, wherein the sterilizing element is contained within a sealed housing having sidewalls and at least one end adapted to be opened.

74. The method according to claim 73, further comprising forcibly engaging the working end-site through the at least one end adapted to be opened to engage the sterilizing element contained within the housing.

75. The method according to claim 73, further comprising expelling the anti-pathogenic agent from the sterilizing element and onto the working end-site by applying inward pressure to the sidewalls of the housing.

76. The method according to claim 73, further comprising applying inward pressure to the sidewalls to transition the at least one end from a sealed configuration to an open configuration to access the sterilizing element contained within the housing.

77. The method according to claim 73, further comprising single-handily transitioning the at least one end from a sealed configuration to an open configuration using fingers on a single hand.

78. The method according to claim 70, wherein the sterilizing element is pre-moistened with a sufficient amount of the anti-pathogenic agent to disinfect the site end and achieve a fast drying rate.

79. The method according to claim 70, further comprising compressing the sterilizing element to expel the anti-pathogenic agent from the sterilizing element and onto the working end-site.

80. The method according to claim 79, wherein compressing the sterilizing element comprises engaging the working end-site in the recessed cavity and inner contours and onto the outer exterior contours of the sterilizing element.

81. The method according to claim 70, wherein the working end-site is removed from the sterilizing element and is air-dried for a period of time of less than about 7 seconds.

82. The method according to claim 70, wherein the step of wiping and sterilizing the working end-site comprises engaging the pre-shaped contours of the sterilizing element and employing a twisting or push/pull motion to contact to and engage and to wipe the working end-site with the pre-shaped contours of the sterilizing element.

83. The method according to claim 70, further comprising frictionally engaging the working end-site into the contours of the recessed cavity of the sterilizing element such that the working end site is engaged and retained within the recessed cavity until the working end-site is ready for use.

84. The method according to claim 70, further comprising frictionally engaging the working end-site onto the outer exterior contours of the sterilizing element such that the sterilizing element is engaged and retained on the working end-site until ready for use.

85. The method according to claim 70, wherein the working end-site further comprises a shroud having an inner surface and wherein the outer exterior of the sterilizing element is shaped and sculpted to contour and contact the inner surface of the shroud and wherein the step of inserting the working-end site into the recessed cavity of the sterilizing element further comprises contouring and contacting the inner surfaces of the shroud with the outer exterior of the sterilizing element.