Universal sterilizing tool

• US 8,273,303 B2
• Filed: 09/18/2008
• Issued: 09/25/2012
• Est. Priority Date: 05/06/2008
• Status: Active Grant

• Current Assignee: 1Worldvista Medical, Inc.
• Original Assignee: Michael J. Ferlic
• Inventors: Ferlic, Michael J., Ferlic, Charlotte P., Ferlic, Mason J., Powley, Nicholas
• Primary Examiner(s): Joyner, Kevin
• Application Number:
  US12/300,717
• Publication Number:
  US 20100172794A1
• Time in Patent Office: 1,468 Days
• Field of Search: 604/905, 422/294
• US Class Current: 422/294
• 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 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, a removable cover secured over the at least one end and adapted to be opened, and sidewalk having outer walls;

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 working end-site, the recessed cavity having a continuously tapered inner surface shaped and sculpted to contour to and contact the outer surfaces of the working end-site and a raised base portion comprising a projection shaped to contour and contact the inner surfaces of an interior lumen of the working end-site, wherein the entire sterilizing element is impregnated with an anti-pathogenic agent; and

a second sterilizing element contained and secured within the removable cover, the second sterilizing element including 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 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.

2. The device according to claim 1, 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.

3. The device according to claim 1, 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.

4. The device according to claim 1, wherein the at least one end comprises a peel-away lid.

5. The device according to claim 1, 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.

6. The device according to claim 1, wherein the housing comprises an envelope of a flexible material, and wherein the sterilizing element comprises a contoured lining of the envelope.

7. The device according to claim 1, wherein the at least one end adapted to be opened comprises a frangible lid.

8. The device according to claim 1, wherein the at least one end adapted to be opened comprises a pre-scored lid.

9. The device according to claim 1, further comprising a protective cover secured adjacent to the at least one end adapted to be opened.

10. The device according to claim 1, wherein the housing further comprises a removable cover attached to a top portion of the housing by a tear line.

11. The device according to claim 1, wherein the device is disposable after a single use.

12. The device 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 device engages the working end-site of the medical device and is retained on the working end-site until ready for use.

13. The device according to claim 1, wherein an outer exterior of the sterilizing element is shaped and sculpted to contour and contact an inner shroud surface of a medical device.

14. The device according to claim 13, wherein the 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.

15. The contoured sterilizing element according to claim 13, 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.

16. The device according to claim 1, wherein the housing comprises an ergonomic shape and is sized to be held and opened by a user'"'"'s fingers on one hand.

17. The device according to claim 1, wherein the housing is configured to opened single handedly.

18. The device according to claim 1, wherein the housing comprises at least one depression formed in the sidewalk for guiding placement of a user'"'"'s fingers.

19. The device according to claim 1, 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.

20. The device according to claim 1, wherein the housing is sealed to maintain a level of moisture within the housing.

21. The sterilizing device according to claim 1, wherein the recessed cavity is configured to contour and contact the outer surfaces of the working end-site.

22. 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;

a first sterilizing element contained and secured within the housing, the entire sterilizing element impregnated with an anti-pathogenic agent, at least one end of the sterilizing element configured to inwardly receive a working end-site a medical device therein, the at least one end shaped to contour and contact the outer surfaces of the working end-site, and a raised base portion comprising a projection shaped to contour and contact an inner lumen surface of the medical device; and

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.

23. The sterilizing device according to claim 22, 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.

24. The sterilizing device according to claim 22 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.

25. The sterilizing device according to claim 22, 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.

26. The sterilizing device according to claim 22, wherein at least the first end of the housing comprises a frangible lid.

27. 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 towards 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;

wherein the outer wall of the impregnated article comprises a plurality of raised contouring and contacting structures; and

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.

28. The sterilizing element according to claim 27, 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.

29. The sterilizing element according to claim 28, wherein the raised base portion is contoured and comprises any one of a nipple, a nub, a bump, a tine, or other projection.

30. The sterilizing element according to claim 27, wherein the recessed portion further comprises a plurality of raised contouring structures on the inner surface.

31. The sterilizing element according to claim 30, wherein the plurality of raised contouring structures on the inner surface comprises any one of ridges, flanges, steps, threads, or combinations thereof.

32. The sterilizing element according to claim 27, wherein the recessed portion further comprises an inner diameter smaller than an outer diameter of the working end-site of the medical device.

33. The sterilizing element according to claim 27, wherein the element is disposable after a single wiping and sterilizing application.

34. The sterilizing element according to claim 27, 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.

35. The sterilizing element according to claim 27, wherein the impregnated article comprises any one of an absorbent material, a pre-moistened material, a particulate-free absorbent material, or a viscoelastic material.

36. The sterilizing element according to claim 27, wherein the impregnated article comprises a die-cut, shaped, molded, or sculpted piece.

37. The sterilizing element according to claim 27, wherein the anti-pathogenic agent comprises any one of an antiseptic, antibacterial, anti-viral, microbiocidal, disinfectant, an oligodynanmic metal or a combination thereof.

38. The sterilizing element according to claim 27, further comprising a housing having at least one end adapted to be opened, wherein the sterilizing element is contained and secured within the housing.

39. The sterilizing element according to claim 38, 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.

40. The sterilizing element according to claim 27, 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.

41. The sterilizing element according to claim 27, wherein the outer wall and inner recessed cavity are shaped and sculpted to contour and contact and form-fit an inner surface of a medical device shroud.

42. 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;

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;

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.

43. 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;

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;

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

at least one of a second sterilizing element, a drying element, or a mating connector located in the second portion of the housing.