# Patent

## Title
Female Luer connector disinfecting cap

## Abstract

A cleaning device for a site of a medical implement is disclosed. The cleaning device can include a cap having an opening to an inner cavity, and the opening can be adapted to receive a site of the medical implement. The inner cavity can include a male luer protrusion that extends up from an inner wall toward the opening, and can be sized and adapted for insertion into a female luer when the cap is provided on the medical implement. The cleaning device can further include a cleaning material that contains a cleaning agent prior to receipt of the site of the medical implement, i.e. the cleaning material is pre-loaded with the cleaning agent, to swab and clean the site with the cleaning agent. The cap can further include a friction-forming member for creating a friction-based fitting of the cap onto the site of the medical implement.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
The current application claims priority under 35 U.S.C. §119(e) to U.S. provisional application for patent No. 61/330,243, which was filed on Apr. 30, 2010. The current application is also related to co-owned U.S. patent application Ser. No. 11/705,805, filed Feb. 12, 2007, issued as U.S. Pat. No. 7,780,794 on Aug. 24, 2010, and entitled “Medical Implement Cleaning Device.” The disclosures of each of the applications cited in this paragraph are incorporated herein by reference in their entireties.


BACKGROUND
The present invention relates to cleaning devices, and more particularly to a universal connector cap capable of cleansing a connector of pathogens or other harmful materials or contaminants, for example by employing a friction-based fitting to a connector site or other medical implement.
In the medical field, there is often a need to connect tubing to a variety of devices to facilitate the administration of fluids to a patient. To allow tubing and components from different manufacturers of a variety of devices to connect with one another, a standard connector type was developed. The connector type generally consists of a male connector (or “port,” which is used interchangeably herein) being inserted into a female connector whereby friction can keep them together. The taper of the male connector can be adapted to closely match the taper of the female connector to create a friction or compression type connection that is fluid tight. For infusion or aspiration of fluids to or from an intravenous or arterial access line or device, i.e. including, without limitation, a catheter, IV set, extension set stopcock, syringe, valve, etc., this type of connector is known as a Luer fitting, a Luer connector, a Luer lock, or the like. The dimensions of Luer connectors, which are referred to herein generically as a “Luer” or “Luers,” can be found in ISO Standards 594-1 and 594-2.
Luers were later improved with threading mechanisms to allow and assist the two connectors to screw together, whereby friction was again the holding force. This threading was merely an enhancement to enable a user to more easily drive the male and female connectors together. If a female port remains open when not connected, there is an increased risk of infections, leakage of fluid and other problems resulting from having open access to the patient. To eliminate this “open” problem, a rubber port can be used for the female connector that can keep the female port closed until used for injections. The rubber port was typically pierced with a needle, or can be removed to connect the female connector with other tubing.
The female connector was further improved with one of several other features, such as a split septum, biased septum, displaceable piston etc. that can be displaced from a closed position by the male connector when it needs to be out of the way, but which can spring back to the closed position as required. This device was highly desirable because it eliminated the dangerous needle and its closure was automatic. This device is commonly called a needleless adapter, or a Luer Activated Valve (LAV). For instance, the Luer tapered male port on standard syringes can open a fluid path without a needle, through or around the displaced feature on the female side when the two were pressed or screwed together. After the injection of fluids, the syringe was unscrewed/removed. Upon removal, the needle-free feature (whether a biased plug/piston, split septum or other displaceable construct) is, without user interaction, automatically biased back into its normally closed position.
This improvement simplified the administration of fluids by removing needles and reducing open port risks but still necessitated the use of a disinfecting wipe prior to insertion since the outside features of the connection can still remain exposed to touch and air contamination.
SUMMARY
This document describes features of cleaning devices for medical implements as well as methods for using such devices. In one aspect, a cleaning device includes a cap having an opening to an inner cavity. The opening is adapted to receive a site of the medical implement. The inner cavity includes a male Luer protrusion that extends up from an inner wall toward the opening, and is sized and adapted for insertion into a female Luer when the cap is provided on the medical implement. The cleaning device further includes a compressible cleaning material that surrounds the male Luer protrusion and that contains a cleaning agent prior to receipt of the site of the medical implement, i.e. the cleaning material is pre-loaded with the cleaning agent. The compressible cleaning material is at least partially secured in the inner cavity and adapted to swab and clean the site with the cleaning agent, including cleaning the female Luer and inner lumen therein.
The cap can further include a friction-forming member for creating a friction-based fitting of the cap onto the site of the medical implement. Alternatively, the cap further includes a member, for example one protruding from threading at the opening of the inner cavity, that, once the cap is fitted onto the site of the medical implement, inhibits easy removal of the cap until a force exerted on the cap exceeds a certain threshold of force. The cap can further include one or more energy directors on which a threaded ring is mated to a receptacle in the cap. The cap can be filled with a cleaning material and cleaning solution, such as a foam pad with an antibacterial or antimicrobial solution. Alternatively, the cap can be filled with a gel, foam or wax that includes an antibacterial or antimicrobial component.
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 shows a male cleaning device;
FIG. 2 shows a variation of a cleaning device;
FIG. 3 shows yet another variation of a cleaning device; and
FIG. 4 shows a process flow chart showing at least one feature consistent with an implementation of the current subject matter.



When feasible, like reference symbols in the various drawings indicate like elements.
DETAILED DESCRIPTION
An improved cleaning device has been created that acts as a combination cap and disinfecting swab whereby it screws on or is otherwise fitted onto the closed female side of a Luer activated valves (i.e. LAV). The cleaning device contains features to disinfect or sterilize the external surface of the closed female port, and further protects the surface from further contamination as long as it remains fitted on to the female port. The cleaning device includes the male feature, i.e. the tapered cone or tapered cylinder, to open the female Luer valve as well as clean the outer and inner surfaces of the Luer valve around the septum. Luer activated valves are typically made of very rigid plastics such as polycarbonate or acrylic. The female connection of the Luer has threads and a root diameter.
A cleaning device in the form of a cap to clean the female connection can be provided as exemplified in U.S. patent application Ser. No. 11/705,805, filed Feb. 12, 2007, the contents of which are incorporated herein by reference for all purposes. The cleaning device for a medical implement includes a cap having an opening to an inner cavity. An inner surface of the opening includes one or more threads adapted to receive a site of the medical implement. The cleaning device further includes a cleaning material formed of a compressible material that is at least partially secured or supported in the inner cavity. The cleaning material contains a cleaning agent that effectively eliminates pathogens and other harmful materials from the site and that can be activated from the cleaning material by twisting and fitting the cap onto the site, particularly if the cap is fitted onto the site for a period of time.
The one or more threads of the cleaning device can be provided by a threaded ring adapted to be fixedly positioned at the inner surface of the opening of the cap. Two threads encircle approximately one-quarter to one-half of the inner surface of the threaded ring. A tab extends from each thread, preferably at the lower terminus of each thread. The tab can be made thinner than the rest of the thread, to allow flexure or bending. The threaded ring can be formed by plastic injection molding. The threads are formed such that the threaded ring does not need to be unwound during molding or fabrication. The tabs of each thread engage with the outer threading of a valve or port, and any gap provided thereby allows for compatibility with many sized valves or ports, as well as allows limited evaporation of cleaning solution (such as isopropyl alcohol) that might be inside the cap.
The tabs create friction on one or both outer sides of the female connection of the Luer, thereby preventing the cap from unscrewing from the female connection of the Luer. In some implementations, the threads of the cap correspond to an ISO Luer Standard thread. Each tab presses against the root diameter of the female Luer and presses on the sides of the thread feature of the female connection, thereby creating friction. The threading and one or more protrusions cooperate to create a compression fit and to prevent the cap from accidentally coming off the site onto which it is fitted.
The threads of the cap, and/or the protrusions of added material, can be made of a softer, more compressible material than the cap or the female connector, such as another type of plastic or a rubber, etc. The features pressing on the female side can work in several ways. The added material can press against the more rigid female LAV root or body or threads to create friction. The added material can also displace plastic to create a single use scenario, where the part pressing on the thread pushes against the outside of the thread or on the sides of the thread. The material can further deflect in a variety of ways to make putting on simple, and taking off more difficult.
Additionally the cap can be configured for being pressed on instead of, or in addition to, being screwed on, with material that protrudes from the inner ring or threads of the cap to press against the threads or roots of the female connection of the LAV, similar in function to a star retaining washer. It can have simple features on the press parts that create resistance when pulled off. The protruding “flaps” can be bendable to allow the cap to be forced over the female threads. Once past the threads or a section of threads, the “flaps” can naturally return to their unbent state to prevent the inadvertent removal of the cap. To remove, it may be possible to unscrew the cap where the flaps find the thread track, but the user can just pull off the cap upon exceeding a certain threshold force to overcome the resistance by the added material and/or the threads of the cap.
FIG. 1 shows a cleaning device 100, including a cap portion 102 that includes a cap 104 with an opening 106 to an interior cavity 107. The cap 104 can be formed of rigid plastic, such as high density polyethylene (HDPE) plastic. A removable foil lid 108 is adapted to close the opening 106, and can be sealed on the top outer periphery of the opening 106 by a heat or thermal process. The opening 106 is slightly wider in diameter than the rest of the interior cavity 107 to form a ring receptacle 110 and to be able to receive a threaded ring 112 as described above. The threaded ring 112 can be ultrasonically welded, glued, or otherwise attached into the receptacle 110. The ring receptacle 110 includes a number of energy directors in the form of bumps or protrusions that enable welding or bonding of the threaded ring 112 into the ring receptacle 110. The energy directors also stabilize the threaded ring 112 for proper alignment and mounting, and can resist against turning the threaded ring 112 relative to the cap 104 when the cleaning device 100 is screwed on or otherwise applied to a port or valve.
The top interior wall 114 of the cap 104 includes a male luer protrusion 116 extending up toward the opening 106 of the cap 104, preferably formed as a portion of a tapered cone or cylinder. The male Luer protrusion 116 is ringed by cleaning material 118 formed of a compressible material that is at least partially secured in the inner cavity 107. The depth or height 120 of the cleaning material can be varied, but in preferred implementations the compressible cleaning material is at least the same or shorter height than height 122 of the top of the male luer protrusion 116.
The top interior wall 114 of the cap 104 can have one or more protrusions 116 extending up from the interior wall 114 toward the opening 106 of the cap 104. The one or more protrusions 116 can be used to support a cleaning material 118 such as foam, cotton, or other porous material, or provide stability to a thixotropic cleaning solution as an alternative. The cleaning material exists in the form of a doughnut. In some implementations, the one or more protrusions 116 can be formed of a flexible material to contact and scrub the forward face of a valve or port, such as the septum of a valve.
The cleaning device 100 provides many advantages. For example, the cleaning device 100 can be easily manufactured. The cleaning device 100 can be easily fit on appropriate devices, such as machines. Further, the cleaning device 100 can be manufactured such that the cleaning device 100 fits any Luer thread. The cleaning device can use different tools for threading. When using a dialysis tube, an inner lumen of the hub, outside threads, and the face of hub can optionally also be disinfected. Cores can be redesigned using a custom tool to obtain new design caps. Length and wings can be added to obtain a new tool for the cap. The new tool can be a further enhancement to an existing tool.
FIG. 2 shows an alternative implementation 200 of a cleaning device, similar to the device 100 shown in FIG. 1, in which the male Luer protrusion 202 is formed of a plug of a cleaning material (e.g. foam, cotton, or other porous material) 204 that is preloaded with a cleaning agent 206 such as isopropyl alcohol. The cleaning device 200 has a high confidence level of reducing or eliminating infection. The plug 204 can include the protrusion 202 ringed by a channel 208, and can also include side walls 210 surrounding the outside of the channel 208. The plug 204 can be secured into the interior cavity 212 of the cap by posts 213, by adhesive, or by a series of barbs that extend up from the top interior wall 214 of the cap 216. The posts 213 can be molded by a heat-staking process. Any damage by heat staking can be prevented or minimized by using suitable techniques.
FIG. 3 shows another implementation 300 of a cleaning device, combining certain features from the devices (100, 200) shown in FIGS. 1 and 2. The cap 302 is similar to the caps 104, 216, but the male Luer protrusion 304 can be integral with the cap material 305, i.e. formed of a single mold. A molded “skin” of foam or some other cleaning material layer 308 is overlaid on some or most of the surface of the interior cavity 310, including the male luer protrusion 304. The skin 306 can be soaked with a cleaning agent 308, of a calculated amount to clean the inside and outside surfaces of the female port near the septum. The male luer protrusion 304 provides a seal with the inner lumen of the female luer port. The skin 306 can be thermally bonded, glued, riveted or otherwise attached to the cap material 305.
The inner cavity of the cap (104, 216, or 302) can include a cleaning material laden with a cleaning solution. In some implementations, the cleaning material is a foam material, and the cleaning solution is a liquid that saturates the foam material. Suitable cleaning solutions include isopropyl alcohol, ethyl alcohol, CHG, choloroxylenol (PCMX), providone iodine, etc. The cleaning solution can also include emollients or other components.
In other implementations, the cleaning material and cleaning solution can be formed of a thixotropic substance such as a gel or foam, or of a fluid with high viscosity. The thixotropic substance can include a base viscous substance impregnated with a cleaning solution in a manner to maintain at least a certain degree of viscosity. The thixotropic substance can at least partially fill the interior cavity of the cap (104, 216, or 302), and flow around the valve or port to cover a desired surface area when the cap (104, 216, or 302) is placed on the valve or port.
FIG. 4 shows a process flow chart 400 showing at least one feature consistent with an implementation of the current subject matter. At 402, an opening of a cap receives a site of a medical implement having a female port. The cap has an outer surface including a plurality of vertical ridges on the outer surface while the opening provides access to a single inner cavity that includes a male luer protrusion extending up from an inner wall of the inner cavity toward the opening. The cap also includes, around a periphery of the single inner cavity, threading including a friction-forming member for creating a friction-based fitting of the cap onto the site of the medical implement. At 404, a cleaning material, which includes a cleaning agent and is provided in the single inner cavity surrounding the male luer protrusion upon receipt of the site of the female port into the single inner cavity and the insertion of the male luer protrusion into the septum of the female port, cleans at least one surface of the female port near a septum of the female port.
The implementations set forth in the foregoing description do not represent all implementations consistent with the subject matter described herein. Instead, they are merely some examples consistent with aspects related to the described subject matter. Although a few variations have been described in detail herein, other modifications or additions are possible. In particular, further features and/or variations can be provided in addition to those set forth herein. For example, the implementations described above can be directed to various combinations and sub-combinations of the disclosed features and/or combinations and sub-combinations of one or more features further to those disclosed herein. In addition, the logic flows depicted in the accompanying figures and/or described herein do not necessarily require the particular order shown, or sequential order, to achieve desirable results. The scope of the following claims may include other implementations or embodiments.

## Claims

1. A cleaning device for a female port having a lumen, the cleaning device comprising:
a cap having an opening to a single inner cavity, the single inner cavity including a non-compressible, upwardly directed protrusion extending up from an inner wall of the inner cavity toward the opening but not extending beyond the opening, the opening to receive a portion of the female port, the non-compressible, upwardly directed protrusion having a frustoconical shape with an increasing diameter toward the inner wall of the inner cavity for insertion into the lumen of the female port and the frustoconical shape for creating a friction-based fitting of the cap onto the female port;
a cleaning material in the single inner cavity encircling at least a base of the non-compressible, upwardly directed protrusion, the cleaning material at least partially saturated with a cleaning agent to clean surfaces of the female port with the cleaning agent upon receipt of the site of the female port into the single inner cavity and the insertion of the non-compressible, upwardly directed protrusion into the lumen of the female port; and
a removable seal attached to the cap at the opening to cover the opening and to maintain the cleaning material and cleaning agent within the single inner cavity prior to receipt of the portion of the female port.

2. The cleaning device in accordance with claim 1, wherein the cleaning material is a thixotropic fluid.

3. The cleaning device in accordance with claim 1, further comprising a friction forming member extending out from an inside surface periphery of the opening to the single inner cavity.

4. The cleaning device in accordance with claim 3, wherein the friction forming member includes a threading having a gauge that increases inwardly from the opening toward the inner wall of the cap.

5. The cleaning device in accordance with claim 1, further comprising a threaded ring that is attached to a periphery of the opening to the single inner cavity.

6. A cleaning device for a female port having a lumen, the cleaning device comprising:
a cap having an opening to a single inner cavity, the single inner cavity including a rigid protrusion extending upward from an inner wall of the inner cavity opposite the opening but not extending beyond the opening, the opening to receive a portion of the female port, the rigid protrusion having a frustoconical shape with an increasing diameter toward the inner wall of the inner cavity, the rigid protrusion being sized for at least partial insertion into the lumen of the female port such that the frustoconical shape crates a friction-based fitting with the lumen to secure the cap on the female port;
a cleaning material in the single inner cavity encircling at least a base of the rigid protrusion, the cleaning material at least partially saturated with a cleaning agent to clean surfaces of the female port with the cleaning agent upon receipt of the site of the female port into the single inner cavity and the insertion of the rigid protrusion into the lumen of the female port; and
a removable seal attached to the cap at the opening to cover the opening and to maintain the cleaning material and cleaning agent within the single inner cavity prior to receipt of the portion of the female port.