Universal sterilizing tool

• US 9,561,298 B2
• Filed: 08/22/2012
• Issued: 02/07/2017
• Est. Priority Date: 05/06/2008
• Status: Active Grant

• Current Assignee: 1Worldvista Medical, Inc.
• Original Assignee: Michael J. Ferlic
• Inventors: Ferlic, Michael J., Ferlic, Mason J., Powley, Nicholas R.
• Primary Examiner(s): Joyner, Kevin
• Application Number:
  US13/592,008
• Publication Number:
  US 20120315201A1
• Time in Patent Office: 1,630 Days
• Field of Search: 422/294, 604/905
• US Class Current: 1/1
• 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 gripped 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 sterilizing device comprising:

a housing comprising;

at least one or more open end adapted to receive a working end-site of a medical device;

one or more sidewalls having one or more outer surfaces; and

one or more inner surfaces;

a seal covering the at least one or more open end; and

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

a resilient article comprising a material impregnated with an antipathogenic agent, an antipathogenic agent bonded to the resilient article or both, wherein the resilient article is a lining of the one or more inner surface of the housing, wherein the lining comprises an open recess shaped to receive the working end-site, the open recess comprising;

an open end,

a base portion opposite the open end, wherein the base portion comprises a projecting structural contour, and

a sidewall extending from the base portion to the open end, wherein the sidewall comprises a plurality of projecting structural contours and a first structural contour of the plurality of projecting structural contours adjoins the base portion, wherein one or more structural contour is configured to contact a surface of the working end-site, and wherein the base portion and the plurality of structural contours comprise a single continuous resilient article.

2. The sterilizing element of claim 1, wherein the resilient article is impregnated with the antipathogenic agent and an antipathogenic agent is bonded to the resilient article.

3. The sterilizing element of claim 1, wherein the sterilizing device is configured to produce an audible popping sound when the seal is opened.

4. The sterilizing element of claim 3, wherein the seal is configured to be opened single handedly.

5. The sterilizing element of claim 1, wherein the one or more inner surfaces of the housing comprise one or more protrusions.

6. The sterilizing device of claim 5, wherein the resilient article lines the housing and one or more of the protrusions of the housing form one or more of the plurality of projecting structural contours of the resilient article.

7. The sterilizing element of claim 1, wherein the plurality of structural contours comprise a plurality of raised contouring structures and recessed contouring structures.

8. The sterilizing element of claim 7, wherein the plurality of structural contours comprise one or more of or a combination of contours selected from the group consisting of:

ridges, ribs, steps, threads, and flanges.

9. The sterilizing device of claim 7, wherein one or more of the raised structural contours, one or more of the recessed structural contours or both are configured between the base portion and the open end.

10. The sterilizing element of claim 1, wherein the projecting structural contour of the base portion contacts and structurally engages an inner surface of the working end-site.

11. The sterilizing element of claim 10, wherein the projecting structural contour of the base portion comprises one or a combination of shapes selected from the group consisting of:

a nipple, a nub, a bump, and a tine.

12. The sterilizing element of claim 1, wherein the sterilizing element is a dual-purpose resilient article that is structurally contoured (a) to wipe and sterilize structural contours of the end-site with the structural contours of the sterilizing element and be removed from the end-site after sterilizing the end-site, or (b) to frictionally and form-fittingly engage the structural contours of the working end-site with the structural contours of the sterilizing element and to be left on the working end-site and to be retained on the working end-site until use.

13. The sterilizing element of claim 1, wherein a portion of the base portion comprises the antipathogenic agent.

14. The sterilizing element of claim 1, wherein the first structural contour is configured to contact and to engage a surface of the working end-site.

15. The sterilizing device of claim 1, wherein one or more of the plurality of projecting structural contours is an outward projecting structural contour or an inward projecting structural contour.

16. The sterilizing element of claim 1, wherein the seal is configured to open and comprises one or more openings.

17. A sterilizing device comprising:

a housing comprising;

at least one open end adapted to receive a working end-site of a medical device;

one or more sidewalls having one or more outer surfaces; and

one or more inner surfaces;

a seal covering the at least one open end; and

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

a resilient article comprising a material impregnated with an antipathogenic agent, wherein the resilient article is a lining of the one or more inner surfaces of the housing, wherein the lining comprises an open recess that is a continuous article shaped to receive the working end-site of the medical device, the open recess comprising;

an open end,

a base portion opposite the open end, wherein the base portion comprises a projecting structural contour, and

a sidewall extending from the open end to the base portion, wherein the sidewall comprises a plurality of structural contours and wherein the open recess diameter narrows from the open end to the base portion, and a first structural contour adjoins the base portion, wherein one or more of the plurality of structural contours is configured to contact and to engage a surface of the working end-site, and wherein at least a portion of the resilient article comprises the antipathogenic agent.

18. The sterilizing device of claim 17, wherein the plurality of structural contours comprise a plurality of raised contouring structures.

19. The sterilizing device of claim 17, wherein the plurality of structural contours comprise a plurality of recessed contouring structures.

20. The sterilizing device of claim 17, wherein one or more of the raised structural contours, one or more of the recessed structural contours or both are configured between the base portion and the open end.

21. The sterilizing device of claim 17, wherein one or more of the plurality of projecting structural contours is an outward projecting structural contour or an inward projecting structural contour.

22. The sterilizing device of claim 17, wherein the one or more inner surfaces of the housing comprise one or more protrusions, wherein the resilient article lines the one or more inner surfaces of the housing and one or more of the protrusions form one or more of the plurality of structural contours of the resilient article.

23. The sterilizing device of claim 17, wherein the base portion is ridged and configured to friction fit into at least one of:

a septum and a lumen.

24. The sterilizing device of claim 23, wherein the base portion is configured to actuate a septum and engage a lumen.

25. The sterilizing device of claim 17, wherein one or more of the plurality of structural contours has a diameter less than an outer diameter of the end-site and wherein one or more of the plurality of structural contours is configured to engage one or more outer surfaces of the end-site to form a friction fit and to secure the sterilizing element onto the end-site.

26. The sterilizing device of claim 17, wherein one or more of the plurality of structural contours is thread-able onto the end-site.

27. A resilient contoured sterilizing element for sterilizing an end-site of a needleless connector, the resilient contoured sterilizing element comprising:

a first end and a second end; and

at least one exterior wall extending between the first end and the second end,

the first end comprising an open recess configured to receive the end-site of the needleless connector, wherein the open recess is a resilient continuous article comprising;

an open end,

a contoured base portion opposite the open end, wherein the base portion comprises a projecting structural contour, and

a sidewall extending from the base portion to the open end, wherein the sidewall comprises a plurality of projecting structural contours, wherein the plurality of structural contours array from the base portion to the open end, wherein a first projecting structural contour of the plurality of structural contours adjoins the base portion, wherein one or more structural contour is configured to contact and engage a surface of the working end-site, wherein at least a portion of the sterilizing element comprises an antipathogenic agent, and wherein the contoured base portion and the plurality of structural contours comprise a single continuous resilient article.

28. The sterilizing element of claim 27, further comprising a housing containing the sterilizing element.

29. The sterilizing element of claim 28, wherein the sterilizing element is configured to be entirely removed from the housing and directly held and used by a clinician.

30. The sterilizing element of claim 28, wherein the first and second ends of the sterilizing element are coplanar with one or more openable ends of the housing.

31. The sterilizing element of claim 28, wherein the open end is coplanar with an open end of the housing.

32. The sterilizing element of claim 28, wherein one or more of the plurality of structural contours is coplanar with an open end of the housing and wherein there is one or more gaps between the plurality of structural contours that form one or more cavities with the needleless connector when the needleless connector is engaged with the open recess.

33. The sterilizing element of claim 28, wherein a circumferential gap including one or more cavities is between the housing and the sterilizing element.

34. The article of claim 28, wherein the housing comprises a sealed first end and a sealed second end, where at least one of the sealed first end and the sealed second end are openable and configured to receive the needleless connector.

35. The sterilizing element of claim 34, wherein the seal prolapses and pushes inward and down into the housing when the needleless connector is forcibly engaged through the frangible seal and wherein in together or in combination with one or more of the frangible seal, the housing, and the sterilizing element is configured to remain frictionally secured on the needleless connector until ready for use.

36. The sterilizing element of claim 28, wherein the housing is a single housing having a first end and a second end, wherein the housing comprises a single continuous open cavity from the first end to the second end and wherein at least one of the first end and the second end are openable and wherein the housing includes the sterilizing element.

37. The sterilizing element of claim 28, wherein the housing has one or more openable ends, wherein two or more housings are joined together on an end of the housing and wherein the joined housings are configured to be separated and opened to sterilize one or more end-site.

38. The sterilizing element of claim 28, wherein the housing is rectangular and wherein the housing has one or more end and one or more rectangular openings.

39. The sterilizing element of claim 28, wherein the housing is comprised of a flexible laminated package that envelops and encloses the at least one exterior wall of the sterilizing element.

40. The sterilizing element of claim 27, wherein the sterilizing element and the structural contours is a single continuous resilient article.

41. The sterilizing element of claim 27, wherein the recess comprises a continuous plurality of structures comprised of a single continuous resilient article.

42. The sterilizing element of claim 27, wherein the sterilizing element is absorbent.

43. The sterilizing element of claim 27, wherein one or more of the plurality of structural contours is coplanar with at least one of:

the first end and the second end.

44. The sterilizing element of claim 27, wherein one or more of the plurality of structural contours is coplanar with the open recess and wherein there is one or more gaps between the plurality of structural contours that form one or more cavities with the needleless connector when the needleless connector is engaged with the open recess.

45. The sterilizing element of claim 27, wherein the exterior wall includes a plurality of structural contours, wherein one or more of the plurality of structural contours is coplanar with the open end and wherein there is one or more gap between the plurality of structural contours that form one or more cavities with a housing when the needleless connector is engaged with the open recess.

46. The sterilizing element of claim 27, wherein the open recess extends beyond the threading of the needleless connector when the needleless connector is engaged with the open recess.

47. The sterilizing element of claim 27, wherein the open recess has one or more gap in between one or more of the plurality of structural contours that form one or more cavities with the needleless connector when the needleless connector is engaged with the open recess.

48. The sterilizing element of claim 27, wherein the resilient article is contained within a housing comprising one or more ends that are openable.

49. The sterilizing element of claim 27, wherein the sterilizing element cleans the end-site using at least one of:

a push-pull motion, a wiping motion, a twisting motion, a dabbing motion and a screwing motion.

50. The sterilizing element of claim 27, wherein the resilient article comprises particulate-free material to remove debris from the end-site.

51. The sterilizing element of claim 50, wherein removing debris includes removing at least one of:

microbes and an antipathogenic residue.

52. The sterilizing element of claim 27, wherein a portion of the resilient article is comprised of a semi-rigid resilient material.

53. The sterilizing element of claim 27, wherein the structural contours apply a inclusive layer of antipathogenic agent to one or more surfaces of the end-site.

54. The sterilizing element of claim 27, wherein the resilient article incorporates a ratio of antipathogenic agent to the amount of resilient material and expels a measured controlled amount onto the end-site to promote a dry time less than 7 seconds.

55. The sterilizing element of claim 27, wherein the resilient article is sufficiently rigid to prevent over-compression and to expel a measured controlled amount onto the end-site to promote a dry time less than 7 seconds.

56. The sterilizing element of claim 27, wherein the rigid article prevents an uncontrolled release of antipathogenic agent and to expel a measured controlled amount onto the end-site to promote a dry time less than 7 seconds.

57. The sterilizing element of claim 27, wherein the resilient article is semi-ridged and the structural contours apply a layer of antipathogenic to the needleless connector to promote a sterilization of the needleless connector of less than 11 seconds.

58. The sterilizing element of claim 27, wherein squeezing or pinching the exterior walls of the resilient article expels antipathogenic agent.

59. The sterilizing element of claim 27, wherein one or more ends of the sterilizing element is configured to perform at least one or a combination of:

sterilizing, drying, wiping and cleaning.

60. A resilient contoured sterilizing element for sterilizing an end-site of a needleless connector, the resilient contoured sterilizing element comprising:

a first end and a second end; and

at least one exterior wall extending between the first end and the second end,

the first end comprising an open recess configured to receive the end-site of the needleless connector, wherein the open recess is a resilient continuous article comprising;

an open end;

a contoured base portion opposite the open end; and

a sidewall extending from the open end to the base portion, wherein the sidewall comprises a plurality of projecting structural contours, wherein the diameter of the open recess narrows from the open end to the base portion, wherein a first structural contour of the plurality of projecting structural contours adjoins the contoured base portion, wherein the plurality of projecting structural contours progress from the base portion toward the open end, wherein one or more of the contours is configured to contact and to engage a surface of the working end-site, wherein at least a portion of sterilizing element comprises the antipathogenic agent, and wherein the contoured base portion and projecting structural contours comprise a single resilient continuous article.

61. The sterilizing element of claim 60, further comprising a housing containing the resilient contoured sterilizing element.

62. The sterilizing element of claim 61, wherein the sterilizing element is configured to be entirely removed from the housing and directly held and used by a clinician.

63. The sterilizing element of claim 61, wherein the first and second ends of the sterilizing element is coplanar with one or more openable ends of the housing.

64. The sterilizing element of claim 61, wherein the open end is coplanar with an open end of the housing.

65. The sterilizing element of claim 61, wherein one or more of the plurality of structural contours is coplanar with an open end of the housing.

66. The sterilizing element of claim 61, wherein a circumferential gap is between the housing and the sterilizing element.

67. The sterilizing element of claim 61, wherein the housing is a single housing having a first end and a second end, wherein the housing comprises a single continuous cavity from the first end to the second end and wherein at least one of the first end and the second end are openable.

68. The sterilizing element of claim 61, wherein the housing has one or more openable ends, wherein two or more housings are joined together at an end of the housing and wherein the joined housings are configured to be separated and opened to sterilize one or more end site.

69. The sterilizing element of claim 61, wherein the housing has at least one open end that is oval shape.

70. The sterilizing element of claim 61, wherein inner surfaces of the housing comprise one or more protrusions including at least one or a combination of:

ribs, points and indentations to secure the resilient article.

71. The sterilizing element of claim 61, wherein at least one or a combination of:

ultrasonic welding, adhesives, outward radial expansion and fictional engagement are used to secure to the resilient article to the housing.

72. The sterilizing element of claim 61, wherein the housing comprises one or more labels and wherein one or more labels signify a status of the end-site.

73. The sterilizing element of claim 60, wherein the base portion is ridged and configured to friction fit into at least one of:

a septum and a lumen.

74. The sterilizing element of claim 60, wherein the base portion is sufficiently ridged to actuate a septum, engage a lumen or both.

75. The sterilizing element of claim 60, wherein one or more of the plurality of structural contours is coplanar with at least one of:

the first end and the second end.

76. The sterilizing element of claim 60, wherein one or more of the plurality of structural contours is coplanar with the sidewall.

77. The sterilizing element of claim 60, wherein the exterior wall comprised of one or more of the plurality of structural contours and where one or more contour is coplanar with the at least one or more of the first end and the second end on the exterior wall.

78. The sterilizing element of claim 60, wherein the open recess extends past threading of the needleless connector.

79. The sterilizing element of claim 60, wherein the open recess has one or more gaps in between one or more of the plurality of structural contour.

80. The sterilizing element of claim 60, wherein the open recess includes one or more engaging structural contour on the sidewall.

81. The sterilizing element of claim 60, wherein the base portion comprises one or more engaging structural contours.

82. The sterilizing element of claim 60, wherein the resilient article is contained within a housing comprising one or more ends that are openable.

83. The sterilizing element of claim 60, wherein the antipathogenic agent comprises at least one of:

a liquid antipathogenic agent and a dry antipathogenic agent.