STERILIZING DEVICE WITH PINCH ACTUATED CAP AND HOUSING

• US 20130171030A1
• Filed: 06/13/2012
• Published: 07/04/2013
• Est. Priority Date: 05/06/2008
• Status: Active Grant

• Current Assignee: 1Worldvista Medical, Inc.
• Original Assignee: Matthew Howard Rust, Michael J. Ferlic, Nicholas R. Powley
• Inventors: FERLIC, Michael J., POWLEY, Nicholas R., RUST, Matthew Howard
• Granted Patent: US 9,572,904 B2
• Time in Patent Office: Days
• US Class Current: 422/119
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: A61L 2/235 cellular, porous or foamed
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: A61M 2005/3106 Plugs for syringes without needle
• 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 39/162 with antiseptic agent incorporated within the connector
• CPC Class Codes: A61M 39/20 Closure caps or plugs for connectors or open ends of tubes
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Devices and methods for sterilizing 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 are discussed. The sterilizing device can include a housing, a sterilizing element including an antipathogenic agent configured for sterilizing the working end-site of a medical device, and a cap hingedly coupled to the housing and configured to hermetically seal the sterilizing element within the housing. One or more features on the cap and housing serve to hermetically seal the cap to the housing prior to use.

Claims

1. A sterilization device for use in sterilizing the working end-site of a medical device, the sterilizing device comprising:

a housing including a flexible sidewall having a lower housing section and an upper housing section, and an opening configured to receive the working end-site of a medical device;

a contoured sterilizing element disposed within an interior space of the housing, the contoured sterilizing element including an antipathogenic agent configured for sterilizing the working end-site of the medical device; and

a cap including an annular skirt configured to conformably engage the upper housing section, to cover the opening, and to seal the contoured sterilizing element within the housing, wherein the cap and housing are configured to actuate with respect to each other, and to progressively slip open, when the housing is squeezed on lateral sides of the flexible sidewall.

4. The sterilizing device of claim 1, wherein the upper housing section further comprises a first interference member engaged with a second interference member on the annular skirt of the cap.

7. The sterilizing device of claim 1, wherein the annular skirt includes a first tapered section configured to contact and conformingly engage a first tapered section of the housing, and wherein the first tapered section of the annular skirt is oriented vertically at an angle of between about 60°

to 90°

relative to the longitudinal axis, and wherein the annular skirt further includes a second tapered section configured to contact and conformingly engage a second tapered section of the housing sidewall.

11. The sterilizing device of claim 1, wherein the contoured sterilizing element is a first contoured sterilizing element, the sterilizing device further comprising a second contoured sterilizing element contained within the cap, wherein the second sterilizing element includes an annular-shaped wall having a contoured outer surface and a contoured interior surface, and a contoured interior space including an antipathogenic agent configured for sterilizing the working end-site of a medical device.

12. The sterilizing device of claim 11, wherein the second contoured sterilizing element is configured to contact and engage the first contoured sterilizing element to maintain liquid communication in a closed cap and housing position.

13. The sterilizing device of claim 1, wherein the housing comprises a first material, and the cap comprises a second material different from the first material to facilitate a progressive slip when squeezed by a user'"'"'s fingers.

14. The sterilizing device of claim 1, further comprising a tether extending between the cap and the housing.

19. The sterilizing device of claim 11, wherein one or both of the first contoured sterilizing element and the second contoured sterilizing element is configured to disengage and be removed from the housing or cap, respectively, and remain on the working end-site of the medical device during sterilization.

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20. A sterilization device for use in sterilizing the working end-site of a medical device, the sterilizing device comprising:

a housing including a flexible sidewall formed about a longitudinal axis, the housing having a lower housing section and an upper housing section, and an opening configured to receive the working end-site of a medical device;

a sterilizing element disposed within an interior space of the housing, the sterilizing element being contoured and including an antipathogenic agent configured for sterilizing the working end-site of the medical device;

a cap covering the opening and sealing the sterilizing element within the housing, wherein the cap comprises an annular skirt having a cap surface that contacts a housing surface of the housing, and wherein one or both of the cap surface and the housing surface is angled with respect to the longitudinal axis such that a pinching force applied to a sidewall of the housing transmits an opening force actuating the cap in a direction away from the housing.

24. The sterilizing device of claim 20, wherein one of the cap and the housing includes a detent, wherein the other of the cap and the housing includes a groove, and wherein the detent mates with the groove by interference fit.

25. The sterilizing device of claim 20, wherein the cap and the housing are configured to make an audible popping noise when the cap is disengaged from the housing to indicate that the sterilizing device has been opened.

28. The sterilizing device of claim 20, wherein the cap is tethered to the housing.

29. The sterilizing device of claim 28, wherein the cap is tethered to the housing with a tether, wherein the tether is coupled with an inside surface of the cap and an inside surface of the housing and is enclosed within the sterilizing device.

30. The sterilizing device of claim 20, wherein the cap surface is on an outside of the annular skirt and the housing surface is on an inside of the sidewall of the housing.

31. The sterilizing device of claim 20, wherein the sterilizing element is configured to be disengaged and removed from the housing and remain on the working end-site of the medical device during sterilization.

32. The sterilizing device of claim 20, wherein the sterilizing element is a lining along an inner surface of the housing.

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34. A contoured sterilizing element for sterilizing a working end-site of a medical device, the sterilizing element comprising:

a first member including an antipathogenic agent, the first member further including a first contoured outer surface and a first opening, wherein the first opening comprises a first plurality of inwardly projecting contouring members;

a second member including the antipathogenic agent, the second member further including a second contoured outer surface and a second opening, wherein the second opening comprises a second plurality of inwardly projecting contouring members, wherein the first member is coupled to the second member; and

a base member including the antipathogenic agent, the base member coupled to the second member to form a bottom under the first and second openings and a contoured outer surface, such that the first and second openings and the base member form a contoured cavity, the contoured outer surface and the contoured cavity configured to receive the working end-site of the medical device;

wherein the contoured cavity tapers in a direction from the first member toward the base member, and

wherein the first plurality of inwardly projecting contouring members of the first opening is rotationally offset from the second plurality of inwardly projecting contouring members of the second opening.

36. The sterilizing element of claim 34, wherein the first opening forms a contoured pattern.

42. The contoured sterilizing element of claim 34, wherein the second opening is smaller than the first opening, such that the contoured cavity forms a concentric contoured and tapered opening.

43. The contoured sterilizing element of claim 34, wherein the contoured cavity and the contoured outer surface comprise contouring surfaces that are configured to form fit the sides and terminal end of the working end-site of the medical device and to reduce a sterilization time.

47. The contoured sterilizing element of claim 34, wherein at least one of the first, second, and base members comprises a porous material with capillarity that is configured to maintain distribution of the antipathogenic agent throughout an entirety of the material.

49. The contoured sterilizing element of claim 34, wherein at least one of the first member, the second member, and the base member comprises nanoparticles bonded to a micro-contour, wherein the nanoparticles are configured to enhance sterilizing action of the at least one of the first member, the second member, and the base member.

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52. A method of fabricating a contoured sterilizing element for use in sterilizing a medical device end-site, the method comprising:

individually forming a plurality of members each including a first outer surface, a first end, a second end, and a plurality of inwardly projecting members defining a contoured opening;

attaching a first end of a first member of the plurality of members to an end of a base member;

attaching a first end of a second member to a second end of the first member, such that the first member, second member, and base member define a contoured cavity configured to receive at least a portion of the medical device end-site; and

rotationally staggering the inwardly projecting members of the second member relative to the inwardly projecting members of the first member about a longitudinal axis of the sterilizing element.

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