# Patent

## Title
Cleaning device for male end of intraveneous set

## Abstract

A cleaning device includes a cap having an opening and that defines an inner cavity, and a channel that extends from a bottom of the inner cavity to a bottom of the cap. A plunger includes a domed top surface, a shoulder, and a rod member. The plunger moves toward the bottom of the cap as the domed top surface is contacted by a male protrusion of a male medical implement, to push the rod member and piercing end further into the channel. The crush ribs contact an inner surface of the channel to inhibit reverse movement of the plunger. A cleaning material contains a cleaning agent and is positioned around the rod member and compressed between the bottom of the inner cavity and the shoulder of the plunger to release the cleaning agent around the shoulder to contact the male protrusion.

## Background
BACKGROUND
One conventional solution for protection of a male end of an intravenous (IV) device that is known as a “dual cap”. This device has a cap used to disinfect luer access valves and has a second cap used to cap the male distal end of an IV. However, there is no one-to-one ratio of these two caps for a single access line female-to-male luer interface. Thus, many caps of this set of two caps will be wasted. Further, there is the issue of throwing away unused caps and their associated costs and inconvenience. Also, this system has too many parts, also adding to cost to manufacture.
SUMMARY
This document describes a cleaning device implemented as disinfecting caps. While some caps are designed for attachment to luer activated needle free valves to disinfect and protect them from contamination, the present disclosure describes a cap for BR attachment to the distal tip of an IV set. This distal tip is an open tab and is normally configured as a male luer lock or male luer slip. The cleaning device of the present application will attach to the male distal end of the IV set to disinfect and protect that tip from contamination. Outside of dimensional differences, several key features of the cleaning device include: Threads are located on an outside surface of the cap rather than inside as with other caps; and a friction based plunger internal to the cap is configured to act as a seal to prevent the chemical disinfecting agent from entering into the male distal end of the set. This plunger may or may not be a true seal, but should inhibit entrance of the chemical agent into the line.
Disinfection device for the distal tip of an IV set, in particular the male distal tip of the IV set, is preferably a single use disposable product with a removable foil-sealable opening, either individually sealed or sealed to a strip or plane of seal material. This device includes an IPA soaked sponge inside, and is made of materials compatible with IPA. The threading preferably meets the ISO standard(s) and allows the device to lock onto the distal male luer. In some implementations, the device is green in color. When attached to the distal end of an IV set, the IPA does not enter the fluid line, and can include an internal pin to seal the orifice. Further, the IV set's distal end and sidewalls of the male luer nozzle is be bathed in IPA when the cap is applied onto the luer.
In one aspect, a cleaning device for a male medical implement having a male protrusion, the cleaning device includes a cap that defines an inner cavity having a top and a bottom, the top of the inner cavity defining an opening. The cap further defines a channel that extends from the bottom of the inner cavity to a bottom of the cap, the channel having a diameter that is smaller than a diameter of the inner cavity. The cleaning device further includes a plunger in the inner cavity. The plunger includes a domed top surface, a shoulder below the domed top surface, and a rod member extending below the shoulder to a piercing end. The rod member further includes a number of crush ribs extending laterally from the rod member, the piercing end of the plunger extending into the channel such that the domed top surface and shoulder are positioned proximate the opening in an initial position. The plunger is configured to move toward the bottom of the cap as the domed top surface is contacted by the male protrusion of the male medical implement, to push the rod member and piercing end further into the channel, and such that the crush ribs contact an inner surface of the channel to inhibit reverse movement of the plunger. The cleaning device further includes a cleaning material around the rod member between the shoulder and the crush ribs, the cleaning material at least partially containing a cleaning agent. The cleaning material is compressed between the bottom of the inner cavity and the shoulder of the plunger to release the cleaning agent around the shoulder to contact the male protrusion of the male medical implement.
The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings, and from the claims.



BRIEF DESCRIPTION OF THE DRAWINGS
These and other aspects will now be described in detail with reference to the following drawings.
FIG. 1 is an isometric view of a cleaning device for a male luer end of an intravenous (IV) line.
FIG. 2 is a cut-away view of a housing of the device.
FIG. 3 is a view of a plunger of the device.
FIG. 4 is an assembly drawing showing the plunger in foam before insertion into the housing. Not shown are the seal and chemical agent.
FIG. 5 illustrates the male distal tip of an IV set approaching the opening of a cleaning device.
FIG. 6 shows the male distal tip in contact with the plunger of the cleaning device.
FIG. 7 shows the male distal tip fully inserted into the housing of the cleaning device.
FIG. 8 is a cut-away view of an alternative implementation of a cleaning device.
FIG. 9 illustrates the male distal tip approaching a cleaning device.
FIG. 10 shows the male distal tip in contact with the plunger of the cleaning device.
FIG. 11 shows the cleaning device fully engaged with a male luer end of an IV device.
FIG. 12 is a top-down view of the cleaning device.



Like reference symbols in the various drawings indicate like elements.
DETAILED DESCRIPTION
This document describes a cleaning device in the form of a cap to attach to a male distal end of an IV set to disinfect the male distal end, and to protect that male distal end from contamination. In accordance with some implementations, a cleaning device is provided for a male medical implement having a male protrusion. The cleaning device includes a cap that defines an inner cavity having a top and a bottom, the top of the inner cavity defining an opening. The cap further defines a channel that extends from the bottom of the inner cavity to a bottom of the cap, the channel having a diameter that is smaller than a diameter of the inner cavity.
The cleaning device further includes a plunger in the inner cavity. The plunger includes a domed top surface, a shoulder below the domed top surface, and a rod member extending below the shoulder to a piercing end. The rod member further includes a number of crush ribs extending laterally from the rod member, the piercing end of the plunger extending into the channel such that the domed top surface and shoulder are positioned proximate the opening in an initial position. The plunger is configured to move toward the bottom of the cap as the domed top surface is contacted by the male protrusion of the male medical implement, to push the rod member and piercing end further into the channel, and such that the crush ribs contact an inner surface of the channel to inhibit reverse movement of the plunger.
The cleaning device further includes a cleaning material around the rod member between the shoulder and the crush ribs, the cleaning material at least partially containing a cleaning agent. The cleaning material is compressed between the bottom of the inner cavity and the shoulder of the plunger to release the cleaning agent around the shoulder to contact the male protrusion of the male medical implement.
FIGS. 1-7 illustrate preferred exemplary implementations of a cleaning device for a male luer end of an intravenous (IV) line. In FIG. 1 an isometric view of a preferred implementation is shown. The housing (1) is a unitary body. The housing (1) may be constructed of any material compatible with the cleaning agent that is kept inside. Examples of materials would include silicone, rubber, high density polyethylene, polyurethane, etc. The housing (1) has an opening (5) large enough to allow the insertion of a medical device. Near the opening (5) are threads (2) that in the preferred embodiment are luer threads capable of coupling with other luer threads. As one will note, threads are just one means of attachment, a friction based attachment can also be used to attach to the inserted medical device, which in this case is the male distal end of an IV set or syringe. At the opposing end of opening (5) is closed end (7). Around the periphery of closed end (7) are ribs (6) which help facilitate the user's rotation of the housing. The ribs are which could result in the stripping of threads (2). Housing (1) with opening (5) and closed end (7) serve to create a cavity within the housing.
In FIG. 2 a cross-section of housing (1) is shown. Cavity (16) and plunger wall (13) are formed by opening (5) and closed-end (7). Cavity (16) is open at one end (11) and the other end (17) is closed except where plunger wall (13) begins. Plunger wall (13) is located in the center of the bottom of cavity (16). Plunger wall (13) is open into cavity (16) and has a closed-end (14). Plunger wall (13) is generally cylindrical except it has long channels (12) along its circumference traveling the length of plunger wall (13).
FIG. 3 is a view of the plunger (20). The plunger (20) can be constructed of the same material as the housing or any combination. The plunger (20) is comprised of a domed top-surface (24), a shoulder (21), crush ribs (23) and piercing end (22).
FIG. 4 illustrates an assembly of the cleaning device. This illustrates the plunger (20) piercing the compressible material (30). Piercing is achieved by pushing plunger piercing end (22) through the compressible material. This new assembly will then be pushed into housing (1) cavity (16) first through opening (11). The compressible material can be made to approximate cavity (16) dimensions. The piercing end (22) then seats itself into plunger wall (13) see FIG. 5. The foil seal and chemical agent are not shown.
The crush ribs (23) of piercing end (22) are slightly larger than the diameter of plunger wall (13) so that it acts as a brake on inadvertent movement. FIG. 5 shows a male luer (40) in relation to the assembled invention. FIG. 6 shows male luer (40) in contact with plunger (20). An area (24) of the plunger self-centers itself into the male luer's (40) open lumen (42). The dome (24) acts to seal or inhibit fluid flow into or out of open lumen (42). The male luer (40) has dimensions defined by an ISO standard. The wall (41) of the lumen (42) has a defined outer dimension and taper. The largest diameter is away from opening (42). The largest diameter of (41) is slightly smaller than the diameter of cavity (16). This dimensional difference creates a gap (11) between wall (41) and the wall of cavity (16). This gap is important because it allows the chemical agent to “wick” up the walls of (41) to disinfect these areas and the gap serves as a means to allow venting of extra pressures created within the housing as the male luer (40) is inserted. If this venting were not allowed then the chemical agent when compressed, would need to find escape, in this case it would be up through (42).
FIG. 7 shows the male luer (40) fully inserted into the housing. As the compressible material (30) is compressed it releases the chemical agent to clean, scrub and disinfect the male luer (40) and walls (41). As the male luer (40) continues its travel into the housing, the dome (24) remains seated to seal opening (42). The ribs (23) continue to act as a braking force to maintain dome (24) contact with opening (42). The plunger (20) can only be moved down into plunger wall (13) by the mechanical force of male luer (40) and its threads (43). Note the gap (11) still exists. Similarly, the plunger wall (13) must also be vented. As the plunger (30) moves down into wall (13) the trapped fluids and/or gases must vent or the unit may not function. Channels (12) serve that purpose. Attached is a cross-sectioned top view of the plunger wall FIG. 12. Accordingly, there is no need for biasing the plunger as with conventional devices.
FIGS. 8-11 illustrate various alternative implementations of a cleaning device. The main difference is in the plunger wall design. In FIG. 8, one can see the plunger wall is defined by two or more splines (50). As seen in FIG. 11, these splines hold the plunger assembly in place and splay outward to provide the braking force.
In the implementations described herein, chemical agents that could be used include, but not be limited to, isopropyl alcohol, chlorhexidone gluconate, chlorhexidone diacitate, povidone-iodine, ethanol, etc.
The lid (not shown), can be made from foil laminates or even non-paper materials that could be easily broken away to allow access. In preferred implementations, the lid is thermally or electrothermally bonded to or near the opening of the cap, and can be peeled away for cleaning the IV device. A lid in the configuration of a strip or planar piece of material could be configured to allow multiple devices to be placed on it, to allow each cap to be pulled away and used independently and separately. Alternatively, each cleaning device could be sealed and used on individual basis.
Although a few embodiments have been described in detail above, other modifications are possible. Other embodiments may be within the scope of the following claims.

## Claims

1. A cleaning device for a male medical implement having a male protrusion, the cleaning device comprising:
a cap that defines an inner cavity having a top and a bottom, the top of the inner cavity defining an opening, the cap further defining a channel that extends from the bottom of the inner cavity to a bottom of the cap, the channel having a diameter that is smaller than a diameter of the inner cavity;
a plunger in the inner cavity, the plunger includes a domed top surface, a shoulder below the domed top surface, and a rod member extending below the shoulder to a piercing end, the rod member further having a plurality of crush ribs extending laterally from the rod member, the piercing end of the plunger extending into the channel such that the domed top surface and shoulder are positioned proximate the opening, the plunger being configured to move toward the bottom of the cap as the domed top surface is contacted by the male protrusion of the male medical implement, to push the rod member and piercing end further into the channel, such that the crush ribs contact an inner surface of the channel to inhibit reverse movement of the plunger; and
a compressible cleaning material around the rod member between the shoulder and the crush ribs, the compressible cleaning material at least partially containing a cleaning agent, the compressible cleaning material being compressed between the bottom of the inner cavity and the shoulder of the plunger as the domed top surface is being contacted by the male protrusion of the male medical implement, to release the cleaning agent around the shoulder to contact the male protrusion of the male medical implement.

2. A cleaning device for a male medical implement having a male protrusion, the cleaning device comprising:
a housing having an opening to an inner cavity the receive the male medical implement, and further having a channel extending from the inner cavity opposite the opening to a bottom of the housing, the channel having a diameter that is smaller than a diameter of both the opening and the inner cavity;
a compressible cleaning material in the inner cavity and at least partially containing a cleaning agent;
a plunger having a domed top surface, a shoulder below the domed top surface, and an elongated rod member extending below the shoulder that terminates at a piercing end, the rod member further having a plurality of crush ribs extending laterally from the rod member, the plunger being positioned within the housing such that, prior to receiving the male medical implement, the domed top surface and shoulder are positioned in the inner cavity proximate the opening, the plurality of crush ribs and piercing end are positioned in the channel proximate the inner cavity such that the crush ribs contact an inner surface of the channel to inhibit reverse movement of the plunger, and at least part of the elongated rod member between the plurality of crush ribs and the shoulder is surrounded by the compressible cleaning material;
the plunger being configured to move toward the bottom of the cap as the domed top surface of the plunger is contacted by the male protrusion of the male medical implement, to push the piercing end, the crush ribs and at least some of the elongated rod member further into the channel toward the bottom of the housing, and to compress the compressible cleaning material with the shoulder of the plunger in the inner cavity to release the cleaning agent around the shoulder to contact the male protrusion of the male medical implement.

3. The cleaning device in accordance with claim 2, wherein the inner cavity includes a widened side wall area to enable the cleaning agent to traverse the shoulder of the plunger after the male protrusion of the male medical implement has pushed the plunger further into the inner cavity and the channel.

4. The cleaning device in accordance with claim 2, further comprising threads that extend outwardly from an outer surface of the housing.