Infusible hazardous drug (HD) fluids in medical therapy pose a significant risk to the patients, health care workers and other individuals in both inpatient and outpatient treatment facilities. FDA regulations such as USP797 and USP800 have been enacted to require the use of safer devices to reduce HD exposures. These safety devices include closed system transfer devices (CTSD) that help prevent HD fluid from escaping the fluid pathway and entering the external environment. Although CTSDs have greatly reduced HD exposures in the health care setting, problems remain. Once such problem is that a droplet of HD fluid residue may linger at the junction of IV tubing connectors when they are disconnected. This residue may not be visible to the naked eye, which may lull healthcare workers into a false sense of security, believing it is not there. These droplets may contaminate healthcare workers fingers or gloves, or the droplets may be dislodged and “flicked” into the environment during handling. Further, these droplets may vaporize into the air around healthcare workers and others where it can be inhaled.
When healthcare workers observe this HD residue on connectors they may use a gauze pad (or similar) to wipe away the residue. However, HD fluid residue can soak through the gauze and get on fingers or gloves. Furthermore, the gauze may facilitate greater evaporation of the HD fluid into room air and will continue to do so even after it is discarded into HD waste containers that are not airtight.
What is needed is a capping device that can be applied to HD tubing connectors after disconnection that absorbs and deactivates HD fluid residues that remain on HD connectors after use. Also, this capping device needs to be closeable and sealable after use to capture HD residues within the capping device and prevent it from vaporizing into the environment.
The disclosure of the present invention relates to a medical fitting capping device or more specifically, to an absorbent closeable cap for HD fluid tubing connectors, particularly those connectors used during administration of chemotherapy.
The present invention, or closeable absorbent cap (the cap) comprises an extended body structure (housing) with a closed end and an internal cavity, the open end of the housing configured to receive a target connector and removably attach to it, the cavity containing dry highly absorbent material hereafter called a “sponge”, the open end of the cap being sealed by a lid closure or plug before use that may remain tethered to the housing when covering a target connector and may be replaced onto the open end of the cap when it is removed from the target connector.
In the first embodiment of the invention, the cap's open end is configured to screw onto a target needleless injection site (NIS) commonly used in infusion therapy in the same fashion as currently used disinfectant caps for NIS. Instead of a fluid-soaked sponge such those used in current disinfectant caps, the invention utilizes a dry, highly absorbent material or sponge that soaks up HD fluid residue that may be present on the end of the NIS when the cap is screwed onto an NIS. The cap is sealed by an airtight closure such as a lid or plug (plug-seal) prior to use to maintain its sterility and prevent ambient vapors from being absorbed into the cap's absorbent sponge. The plug-seal is unremovably attached to the cap's housing by a tether than enables the plug to move a sufficient distance away from the cap opening in order to not impede it being applied to a target NIS. The tethered plug-seal may be replaced back into the opening of the cap after removal from a target NIS in order to retain any absorbed HD fluid within the cap and prevent hazardous vapor from escaping from the re-sealed cap. The plug-seal recreates an airtight seal when replaced in the cap opening to retain HD fluid vapors within the re-sealed cap. Preferably, the absorbent sponge in this and all other embodiments contains or is impregnated with a substance that deactivates hazardous substances. One example of such a deactivating agent is activated carbon, which is currently used to deactivate HD fluid when cleaning up accidental spills. The deactivating component of the sponge, such as carbon, may be impregnated throughout the sponge material, or it may be a separate component or layer underlying the sponge. The face of the sponge receiving the target connector may have a variety of shapes including concave and convex to facilitate contact of the target connector's fluid pathway opening and adjacent face and threads.
In a second embodiment of the invention, the cap's open end is configured to receive a male luer fitting such as an IV tubing end, and particularly a closed male luer (CML) connector commonly used in HD therapy.
In a third embodiment, the cap is configured to receive an NIS on one end and a male-luer connector on the other end. This dual-purpose cap may have a partition in the center to keep the sponge chamber in each side of the cap disparate. This enables a single two-function cap to cover the end of either an NIS (female) connector or a male luer connector.
In a fourth embodiment, the cap may be configured without threads so that a target connector may be inserted into an enlarged internal cavity with a friction fit or snap-on fitting. This embodiment is much like “dust covers” currently used to protect the sterile ends of HD connectors during transport from the pharmacy to the patient care area. It is contemplated that current dust covers may be adapted for use as an absorbent cap by adding an absorbent sponge. This fitted embodiment is typically designed to correspond to a specific brand and make of connector. This fitted cap would contain a sponge at its closed end as with the above embodiments, and preferably would contain a sponge impregnated with a deactivating substance.
In a fifth embodiment, the tethered plug-seal described in the first embodiment may be replaced by seal that is not tethered. Rather, this plug-seal may be removed immediately before it is used to cover a target connector and set aside. Preferably, this plug-seal may be attached to the closed end of the cap, much like how the removable cap of a writing pen can be removed from its tip and attached to the opposite end on the pen for later use covering the pen tip. After the cap is removed from its target connector, this plug-seal can be removed from the base of the cap and re-placed onto the same opening it was removed from in order to seal harmful vapors within the cap. It is contemplated that this cover may be designed to snap onto the used cap so it cannot be inadvertently removed, releasing potentially harmful vapors into the surrounding air.
In a sixth embodiment, is a cap that is not entirely rigid and may be described as a sealable pouch. The opening to the pouch is formed around a deformable material such as bendable wire so that the user can squeeze the opening ends together to open it, much like a slitted coin change purse. A target connector can be inserted into the cap, followed by pressing and bending the deformable opening around the connector to both seal it off from the surrounding environment, and keep the cap attached to the connector. In this embodiment, it is contemplated that an entire connector can be inserted into this elongated cap, removed from the vascular access device, and then sealed within the cap by squeezing the bendable opening together.
In a seventh embodiment, the front end of a cap is fitted with an absorbent sponge as in the above embodiments. The opposite end of the same cap is comprised of a disinfectant cap for application to the same target connector after removal of the absorbent cap. This disinfectant end of the cap having a seal, such as foil, that is of different make, shape and color to distinguish it from the absorbent end of the cap, the seal being removable and not tethered. This embodiment enables the user to use the absorbent end of the cap to remove and isolate HD residue followed by disinfection of the same cap.
In an eight embodiment, the cap may be provided in a specialized packaging format in which at least two caps are packaged in a carrier strip that may be hung from a device such as an IV pole boom. Caps may be fitted into a hole in a strip prior to the tethered plug-seal being wrapped over the edge of the strip and sealing onto the top opening of the cap positioned through the hole. The tethered plug-seal has a wider diameter than the hole in the strip so that a sealed cap cannot slip out of the bottom side of the strip. The hole is sized to fit over the opening rim of the cap, but smaller than the diameter of the tri-lobed housing so that a sealed cap cannot slip out of the top of the strip. To remove a cap from the strip, the user removes and lifts the tethered plug-seal off the cap opening then grasps the cap housing underneath the strip and pulls the untethered cap out through the bottom of the strip. The loop in the plug-seal's tether further keeps the cap from slipping out of the strip unintentionally. The strip may be slitted or scored where the loop of the tether wraps around the strip so that this slit deforms or tears apart so that the loop and cap can be pulled off of the strip without removing the plug seal. This may be needed if the cap is not going to be used immediately.
The following description of the invention can be understood in light of the Figures which illustrate specific aspects of the embodiments and are part of the specification. Together with the following description, the Figures demonstrate and explain the principles of the invention. In the Figures, the physical dimensions of the embodiment may be exaggerated for clarity. The same reference numerals or word descriptions in different drawings represent the same or similar element, and thus their descriptions may be omitted.
The present invention or absorbent cap 100, as described in
This application is claims priority to and the benefit of U.S. Provisional Patent Application No. 63/182,645, filed on Apr. 30, 2021, which is hereby incorporated by reference in its entirety.
Number | Date | Country | |
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63182645 | Apr 2021 | US |