Integrated male and female Luer scrubbing device with flush syringe

Abstract

An integrated disinfection device assembly is described, the syringe assembly having two integrated disinfection units attached to the syringe for disinfecting and sterilizing a corresponding medical connector, specifically the access port of a corresponding medical connector. The integrated disinfection unit includes a needleless connector disinfection unit (NCDU) and a male Luer disinfection unit (MLDU) disposed on the syringe assembly. The NCDU has a first chamber containing a first absorbent material, a first disinfectant or antimicrobial agent within a first housing, and a first peelable seal. The MLDU for male medical connectors comprises a housing, a scrubbing foam having multiple slits disposed within a first cavity of the housing, a central post extending from the closed bottom of the housing and located within the first cavity of the housing, a scrubbing foam disposed around the periphery within the inner surface of the integrated body, a foam cover disposed on the central post and having multiple slits, a central plug disposed in the center of the central post extending from the top wall of the central post and into a second cavity of the foam cover, a second disinfectant or antimicrobial agent, and a second peelable seal. The inner surface of the foam cover defines the second cavity. A threaded connector is disposed on the bottom outer surface of the first scrubbing device, having threads formed and developed to engage with the threads of a Luer lock collar on the distal end of a syringe barrel to enable connection of the proximal housing to a syringe assembly. The MLDU and the syringe assembly are integrally connected at the thumb press of the syringe and the ledge of the MLDU. In one or more embodiments, the MLDU and the syringe assembly are interlocked through an interference fit or snap fit between the thumb press of the syringe and the ledge of the MLDU.

Description

[[Technical Field]]

[0001] The present disclosure generally relates to an integrated disinfection device assembly that includes both a Needleless Connector Disinfecting Unit (NCDU) comprising a scrubbing device for scrubbing and disinfecting a needleless connector (NC) or female luer connector, and a Male Luer Disinfecting Unit (MLDU) comprising a scrubbing device for scrubbing and disinfecting a male luer connector. The NCDU comprises a proximal housing, a distal housing, a first closed proximal end, and a first annular wall extending from the first closed proximal end to a first open distal end that defines a first chamber, a first absorbent material, a first disinfectant, and a first peelable seal. The MLDU comprises an integral body, a second closed proximal end, and a second annular wall extending from the second closed proximal end to a second open distal end that defines a second chamber containing an outer scrubbing foam, a foam jacket, a central plug, a second disinfectant, and a second peelable seal. The present disclosure also generally relates to a syringe assembly having both an NCDU and an MLDU attached to a syringe for disinfecting and sterilizing both a corresponding female medical connector and a corresponding male medical connector, specifically the access ports of corresponding medical connectors. [[Background Art]]

[0002] Vascular access devices (VADs) are commonly used therapeutic devices, including intravenous (IV) catheters and needleless access devices. VAD operation is often impaired or completely obstructed by the occurrence of thrombus formation. Thrombosis is the progression of blood clots within blood vessels and / or within vascular access devices. If not properly maintained or exposed to non-sterile environments, VADs can become contaminated, clotted, or spread infection. When connecting to a VAD to deliver fluids or medications, bacteria and other microorganisms can enter the patient's vascular system from the access hub, port, or valve. Each of the access hub, port, valve, or connection point is associated with some risk of transmitting catheter-related bloodstream infection (CRBSI), which can be costly and potentially fatal. Practice standards, including disinfection and cleaning procedures, have been developed to reduce the incidence of CRBSI and ensure that VADs are used and maintained correctly. Protocols have been developed to ensure sterilization practices to guarantee that VADs are used properly and do not become blocked or infected. These protocols include sterilization of the VAD and flushing of the catheter with a flushing solution. The catheter is flushed using a syringe assembly filled with various fluids. In some cases, different fluids, including a locking solution, are injected sequentially according to the protocol. For example, the locking solution may be 4% sodium citrate or saline, followed by an anticoagulant such as heparin. VAD protocols typically recommend performing flushing procedures after catheter placement, before fluid injection, and before and after drug administration, blood collection, blood transfusion, and parenteral nutrition. The purpose of these flushing procedures is to confirm catheter patency, avoid drug incompatibility, ensure complete drug dose delivery, prevent thrombus formation, and minimize the risk of bloodstream infection.

[0003] In developed countries' markets, when using IV catheters, a needleless connector is typically used to close the system, and then access is made to that needleless connector to administer medication or other necessary fluids to the patient through the catheter. The Infusion Nurses Society (“INS”) standards of practice recommend the use of needleless connectors, stating that “before each access, they should be consistently and thoroughly disinfected using alcohol, iodine tincture, or a chlorhexidine gluconate / alcohol combination.” Disinfection of the needleless connector is ultimately intended to help reduce bacteria that may survive on the surface and lead to various catheter-related complications, including CRBSI. Nurses typically complete this disinfection process by using a 70% isopropyl alcohol (IPA) pad and performing what is known as “scrubbing the hub.” However, compliance with this practice is usually very low. In addition to a lack of compliance with the "scrub the hub" requirement, interviews with clinicians have also indicated frequent variability in scrubbing time, drying time, and the number of times needleless connectors are scrubbed.

[0004] Numerous risks of contact or contamination exist throughout the entire sequence of procedures involved in the transmission of microorganisms that can cause CRBSI. For example, contamination can occur during drug mixing, cannula attachment, and insertion into the access hub. Furthermore, threaded connectors have open luers with exposed lumens. Because the procedure for connecting to a VAD is so common and simple, the risks associated with entering the patient's vascular system have often been overlooked. Currently, the risks to the hospital and the patient are substantially correlated with the diligence of the clinician performing the connection, and this diligence is largely beyond control.

[0005] VAD standards and practices typically include disinfecting both the threaded male connector and the IV catheter connection. While this additional disinfection step reduces the potential for contamination, it also increases the potential for non-compliance with the disinfection procedure.

[0006] Current “recommended practices” for maintaining sterile IV lines and administering IV medications require adherence to a stepwise process known as “SASH.” In the first step of this process, the clinician cleans / disinfects the VAD connector (typically with an alcohol swab). Secondly, the IV line or catheter is flushed using a syringe containing saline solution (saline flush), after which the VAD connector receives a second disinfection. Thirdly, fluid or drug treatment is administered via the IV line or catheter (treatment), after which the VAD connector receives a third disinfection, followed by a second saline flush step. The final step, which depends on the patient’s needs and facility policy, is the final disinfection of the VAD connector, followed by a 4% sodium citrate or heparin lock step, where a small amount of 4% sodium citrate or heparin is injected into the IV line or catheter to prevent thrombus or clot formation. Individual disinfection caps may be used to sterilize the VAD hub. This "recommended practice," which requires disinfecting the VAD connector after each access, makes IV line maintenance an extremely cumbersome and time-consuming process. Because the process is so cumbersome, clinicians are less likely to fully implement this "recommended practice," and therefore patients are at risk of contracting CRBSI. Microorganisms can inhabit the exposed connector inlet surface, and if the "recommended practice" is not followed, these microorganisms can enter the IV line during flushing. Furthermore, backflow of blood into the IV line or catheter can cause clot formation inside the line, and microorganisms from the connector inlet surface can colonize the blood clots inside the line and infect the patient during flushing.

[0007] Current practices require users to obtain a separate disinfection unit product to ensure the cleanliness of the VAD connector, for example, after saline flushing and before subsequent steps such as drug infusion. Therefore, there is a need for an integrated disinfection unit attached to a syringe that would facilitate compliance with sterile procedures by eliminating additional wiping and disinfection steps while reducing the number of individual flushing and disinfection devices used in current practices.

[0008] Currently, the workflow for disinfecting the hub involves only one device, which is typically an IPA pad or a similar IPA scrubbing device. After public health procedures are performed, the line is flushed with a syringe. The medication is then administered to the patient. This pre-administration hub sanitization can easily be omitted because the IPA pad or scrubbing device is not readily available. A second flush is then performed to clean the line. If the IPA pad or scrubbing device is integrated with the flush syringe, the IPA pad or scrubbing device is used to clean the hub before use. Finally, the line is locked with a locking solution (e.g., 4% sodium citrate or heparin), but the hub is not disinfected before administration because the IPA pad or scrubbing device is not readily available. Current products and practices do not address post-flush cleaning, as sanitization ends after the flush. INS guidelines also recommended cleaning the connector before each access. Therefore, current products (solutions) on the market do not include additional scrubbing devices for performing sanitization before administering the drug or locking solution.

[0009] When an IV line with a male lure is not connected to a needleless connector for IV injection, the male lure, including its thread, may not be protected and could become contaminated with bioburden, microorganisms, dirt, etc. Therefore, if a connection between the needleless connector and the male lure is required to resume IV injection, both access points must be scrubbed and disinfected.

[0010] Therefore, there is a need to provide an integrated disinfection device for scrubbing and disinfecting both a needleless connector with a female Luer connector and a male Luer connector that can be connected to an IV line. An integrated disinfection device would improve compliance with scrubbing both the male Luer connector on the IV line and the female Luer connector on the needleless connector to disinfect the hub or connection interface before administering a drug or locking solution. [Overview of the Initiative]

[0011] One aspect of the present disclosure relates to a disinfection device assembly for connection to a medical connector. According to an exemplary embodiment of the present disclosure, the disinfection device assembly generally comprises a needleless connector disinfection unit (NCDU), a syringe, and a male Luer disinfection unit (MLDU).

[0012] The Needleless Connector Disinfection Unit (NCDU) comprises a proximal housing, a distal housing, a first closed proximal end, a first annular wall having a length extending from the first closed proximal end to a first open distal end defining a first chamber containing a first absorbent material, a first disinfectant, or an antimicrobial agent, and a first peelable seal having a first upper web.

[0013] The male Luer disinfection unit (MLDU) comprises a single body, a second closed proximal end, an annular wall extending from the second closed proximal end to a second open distal end defining a second chamber containing a second absorbent material, the annular wall having a ledge extending from the closed end at the second closed proximal end of the annular wall, a second disinfectant or antimicrobial agent in the second chamber, and a second peelable seal having an upper web. The outer scrub foam and foam cover are immersed in the second disinfectant or antimicrobial agent.

[0014] The first open distal end of the NCDU defines an engaging surface for contacting the first peelable seal, and the second open distal end of the MLDU defines a sealing surface for contacting the surface of the second peelable seal.

[0015] A connecting element is disposed on the bottom wall of the NCDU, allowing the bottom wall of the NCDU to be connected to a syringe. In one or more embodiments, a syringe assembly can be attached to the NCDU using a variety of methods, including but not limited to mechanical fasteners, snap fittings, and threaded connectors. In one or more embodiments, the connecting element is a threaded connector, which may include an integrated thread or tab. In certain embodiments, the connecting element is a Luer threaded connector. In one or more embodiments, the threaded connector is disposed on the bottom outer surface of the NCDU of the disinfection unit, having a (pitched) thread formed and developed to engage with the thread of a Luer lock collar on the distal end of the syringe barrel, allowing the NCDU to be connected to a syringe. In one or more embodiments, the bottom wall of the proximal housing of the NCDU includes a threaded post disposed in the center of the bottom wall of the NCDU, which corresponds to the female thread of a locking Luer type collar on the distal end of the syringe barrel.

[0016] In one or more embodiments, the male Luer disinfection unit (MLDU) and the syringe assembly are integrally connected to the thumb press of the syringe. In one or more embodiments, the male Luer disinfection unit (MLDU) and the syringe assembly are interlocked via an interference fit or snap fit between the thumb press of the syringe and the ledge of the MLDU. To provide a snap-fit ​​connection of the syringe assembly to the thumb press, a ledge or wedge may be provided at the closed end of the annular wall of the ML disinfection unit. The inner surface of the top wall of the integrated body, located at the second closed proximal end of the annular wall of the integrated body, may have a recess, ledge, or wedge into which the thumb press can be inserted.

[0017] In one or more embodiments, the second closed proximal end of the second annular wall of the ML disinfection unit includes a peripheral ledge extending radially inward perpendicularly from the annular wall. The ML disinfection unit is fitted to snap onto the thumb press of the plunger rod, opposite the lure tip. In one or more embodiments, the ML disinfection unit may be connected to the thumb press by a rim positioned radially inward on the peripheral ledge to create a lip or rim.

[0018] In one or more embodiments, the inner surface of the peripheral ledge of the inner annular wall surface of the ML disinfection unit at the second closed proximal end includes at least two mating protrusions that allow a thumb press to be connected with the ML disinfection unit via a snap-fit ​​connection.

[0019] The NCDU can achieve disinfection when used on a needle-free connector ("NFC") by concentrating a first disinfectant or antimicrobial agent in a first absorbent material disposed and contained in a first chamber of the NCDU. The male Luer connector can achieve disinfection when it comes into contact with a second disinfectant or antimicrobial agent in a second absorbent material disposed and contained in a second chamber of the MLDU. The first and second disinfectants or antimicrobial agents can be directly incorporated into the first and second chambers, and can be absorbed by the first absorbent material (e.g., sponge or foam material) filling the first chamber of the NCDU and the second chamber of the MLDU, respectively. The NCDU is designed to be compatible with interactions with a variety of disinfectants. In one or more embodiments, the first disinfectant or antimicrobial agent, or the second disinfectant or antimicrobial agent, may include variations of alcohol or chlorhexidine. In one or more embodiments, the first disinfectant or antibacterial agent, or the second disinfectant or antibacterial agent, is selected from the group essentially consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In certain embodiments, the first disinfectant or antibacterial agent, or the second disinfectant or antibacterial agent, comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the first disinfectant or antimicrobial agent, or the second disinfectant or antimicrobial agent, is a fluid or a gel.

[0020] The first absorbent material absorbs the first disinfectant or antimicrobial agent contained within the first chamber of the NCDU. In one or more embodiments, the first absorbent material is a nonwoven material, foam, or sponge. In certain embodiments, the foam is polyurethane foam. In certain embodiments, the first absorbent material is in the form of a foam plug. In one or more embodiments, the first absorbent material includes one or more slits.

[0021] A first peelable seal having an upper web is disposed on the engaging surface of the distal housing to prevent the first absorbent material from leaving the first chamber. With the first absorbent material properly inserted into the first chamber of the NCDU, the first peelable seal can be secured to the engaging surface of the first open proximal end of the NCDU to seal the NCDU.

[0022] A second absorbent material is disposed and contained within a second chamber of the ML disinfection unit and absorbs a second disinfectant or antimicrobial agent contained within the second chamber of the ML disinfection unit. In one or more embodiments, the second absorbent material is a nonwoven fabric, foam, or sponge. In certain embodiments, the foam is polyurethane foam. In certain embodiments, the second absorbent material is in the form of a foam plug. In one or more embodiments, the second absorbent material includes one or more slits.

[0023] A second peelable seal having an upper web is disposed on the engaging surface of the integral body to prevent the second absorbent material from leaving the second chamber. With the second absorbent material properly inserted into the second chamber of the MLDU, the second peelable seal can be secured to the engaging surface of the second open distal end of the integral body to seal the MLDU.

[0024] The first peelable seal and the second peelable seal may be chemically resistant, light-shielding, impermeable, or sterile. In one or more embodiments, the first peelable seal and the second peelable seal include a peel-back top of aluminum or a multilayer polymer film. In certain embodiments, the first peelable seal and the second peelable seal are heat-sealed or induction-sealed to the engaging surfaces of the open ends of the NCDU and ML disinfection units to seal them. In one or more embodiments, the first peelable seal and the second peelable seal provide a moisture barrier.

[0025] The proximal and distal housings and the integrated body are made from any type of plastic material, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the proximal and distal housings and the integrated body include polypropylene or polyethylene material.

[0026] Another aspect of the present disclosure relates to an assembly comprising an NCDU of one or more embodiments of a disinfection device assembly connected to a syringe assembly. The syringe assembly includes a syringe barrel having an elongated body defining a chamber, and a distal end having an open proximal end with a flange and a tip having a passage for fluid communication with the chamber. The distal end of the barrel also includes a locking Luer-type collar concentrically surrounding the tip. The locking Luer-type collar has a female thread. The syringe assembly further includes a stopper connected to an elongated plunger rod having a thumb press at its proximal end. In one or more embodiments, the assembly may further include a medical connector selected from a male Luer connector, a female Luer connector, and a needleless connector.

[0027] Another aspect of the present disclosure relates to a method of disinfecting a medical connector, the method comprising the step of connecting the disinfection device assembly according to an embodiment of the present disclosure to the medical connector, wherein the connecting step comprises: removing the NCDU from the syringe assembly and peeling off the upper web of the first peelable seal from the NCDU; inserting the needle-free connector ("NFC") into the first chamber of the NCDU to bring the NFC into contact with the first absorbent material impregnated with a disinfectant or an antibacterial agent; subsequently, removing the NCDU from the syringe barrel by applying torque to the entire assembly, thereby unthreading the NCDU from the locking luer-type collar at the distal end of the barrel; attaching a flush syringe to an IV catheter line by engaging threads of a luer lock collar on the distal end of the syringe barrel to connect the NFC to the flush syringe, and flushing the IV line; removing the flush syringe from the NFC, peeling off the upper web from the ML disinfection unit to expose the second absorbent material impregnated with a second disinfectant; and inserting the NFC into the chamber of the NCDU to bring the NFC into contact with the first absorbent material impregnated with the first disinfectant or antibacterial agent.

[0028] Another aspect of the present disclosure relates to a method of manufacturing a disinfection device assembly, the method comprising the step of connecting a needle-free connector ("NFC") NCDU to a syringe, wherein the syringe engages the NCDU via a locking luer-type collar, and the ML disinfection unit engages a thumb press. The syringe is connected to the NCDU by engaging a threaded tip cap with a locking luer-type collar provided with internal threading. The syringe is connected to the ML disinfection unit by connecting a syringe assembly comprising an elongated plunger rod further including a thumb press to the ML disinfection unit.

[0029] This Summary of the Invention is provided to introduce concepts in a simplified form that are further described below in the Detailed Description. This Summary of the Invention is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

[0030] Additional features and advantages of the present disclosure will be set forth in the following description, and in part will be obvious from the description, or may be learned by practice of the present disclosure. The features and advantages of the present disclosure may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features of the present disclosure will become more fully apparent from the following description and appended claims, or may be learned by the practice of the present disclosure set forth hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] [Figure 1] FIG. 1 is a perspective view illustrating a sanitization device assembly according to an exemplary embodiment of the present disclosure. [Figure 2] FIG. 2 is an exploded perspective view illustrating a needleless connector disinfection unit (NCDU) according to an exemplary embodiment of the present disclosure. [Figure 3] FIG. 3 is a cross-sectional view of an NCDU according to an exemplary embodiment of the present disclosure. [Figure 4] FIG. 4 is an exploded view illustrating an alternative embodiment of an NCDU according to an exemplary embodiment of the present disclosure. [Figure 5] FIG. 5 is an exploded cross-sectional view of FIG. 4 according to an exemplary embodiment of the present disclosure. [Figure 6] FIG. 6 is a flowchart illustrating a disinfection process for a needle-free connector using an NCDU according to an exemplary embodiment of the present disclosure. [Figure 7] FIG. 7 is an exploded perspective view illustrating a male luer disinfection unit (MLDU) according to an exemplary embodiment of the present disclosure. [Figure 8]This figure shows a cross-sectional view of an MLDU according to an exemplary embodiment of the present disclosure. [Figure 9] This figure shows a perspective view of an MLDU having a removable cap according to an exemplary embodiment of the present disclosure. [Figure 10] This figure shows perspective views of a prior art male connector and MLDU according to exemplary embodiments of the present disclosure. [Figure 11] This figure shows a flowchart of a cross-sectional perspective view of the disinfection process of a prior art male luer medical connector according to an exemplary embodiment of the present disclosure. [Figure 12] This figure shows a side perspective view of a disinfection device assembly 100 having an attached ML disinfection unit 150, according to a first exemplary embodiment of the present disclosure. [Figure 13] This figure shows a side perspective view of a disinfection device assembly 100 having a fitted ML disinfection unit 150, according to a second exemplary embodiment of the present disclosure. [Figure 14] This figure shows a side perspective view of a disinfection device assembly 100 having a screw-in ML disinfection unit 150 according to a third exemplary embodiment of the present disclosure. [Figure 15] This figure shows a side perspective view of a disinfection device assembly 100 having a snap-fit ​​ML disinfection unit 150 according to a fourth exemplary embodiment of the present disclosure. [Modes for carrying out the invention]

[0032] In the current practice of the SASH (saline-administer-saline-heparin) workflow, the clinician begins by removing the disinfectant cap attached to the indwelling catheter hub to be flushed and scrubbing the hub using disinfectant wipes or a scrubbing device. Next, the clinician flushes the venous (IV) line using a flush syringe to ensure the catheter is functioning before infusion. After the first flush, the clinician then scrubs the hub using disinfectant wipes or a scrubbing device and administers the medication into the IV line. After medication administration, the clinician scrubs the hub again using disinfectant wipes or a scrubbing device. Next, the clinician performs a second flush of the IV line using a flush syringe to remove any remaining medication in the catheter and scrubs the hub using disinfectant wipes or a scrubbing device. Finally, the clinician "locks" the IV line using a lock syringe filled with 4% sodium citrate or heparin flush to help prevent thrombus formation within the catheter. Lastly, a new disinfectant cap is attached to the indwelling catheter hub. Therefore, current practice requires four scrubbing devices, two flush syringes, one disinfectant cap, and one lock syringe.

[0033] Before describing some exemplary embodiments of this disclosure, it should be understood that this disclosure is not limited to the configuration details or process steps specified in the following description. Other embodiments of this disclosure are possible and can be practiced or implemented in a variety of ways.

[0034] Embodiments of this disclosure relate to disinfection device assemblies for connecting to medical connectors, including a syringe assembly comprising two integrated disinfection units attached to a syringe assembly for connection to and disinfection of corresponding medical connectors, including threaded connectors. In one or more embodiments, the connector is a male Luer connector or a female Luer connector. The disclosure aims to provide a mechanism that can disinfect both the lumen of an open Luer and the corresponding IV connector while minimizing additional steps in medical management. The disinfection units disclosed herein are intended to be available with male or female threaded connectors. The disclosure aims to provide a mechanism for disinfecting IV needleless connectors during syringe use, thereby saving clinicians time and reducing work steps. The disclosure aims to reduce the number of steps required to prevent contamination of vascular access devices (VADs).

[0035] Embodiments of this disclosure also relate to sterile male Luer disinfection units for connection to and disinfection of medical connectors, specifically male medical connectors. The male connector may be a male Luer connector. Embodiments of this disclosure relate to a male Luer disinfection device that disinfects the threaded surface and outer surface of a male Luer connector by a combination of scrubbing with a disinfectant in the cap and chemical action. Specific embodiments of this disclosure relate to a liquid disinfectant-containing NCDU for use with a male medical connector, capable of providing both passive disinfection using a liquid disinfectant and active disinfection using a scrubbing motion. The MLDU of the integrated disinfection device assembly of this disclosure also prevents the liquid disinfectant from entering the lumen of the male Luer connector.

[0036] The following definitions are provided for terms used in this disclosure.

[0037] As used herein, the use of "a," "an," and "the" includes both singular and plural forms.

[0038] As used herein, the terms “catheter-related bloodstream infection” or “CRBSI” refer to any infection resulting from the presence of a catheter or IV line.

[0039] As used herein, the term “Luer connector” refers to a connection collar, which is a standard method for connecting syringes, catheters, hubbed needles, IV tubes, and the like to each other. A Luer connector consists of male and female interlocking tubes that are slightly tapered to connect by a simple push / twist fit. Luer connectors may optionally include an additional threaded outer rim to allow them to lock more securely. The male end of a Luer connector is typically associated with a flush syringe and can interlock and connect to the female end, which is located on a vascular access device (VAD). A Luer connector comprises a distal end, a proximal end, an irregularly shaped outer wall, and a profiled center passageway for fluid communication from the chamber of the syringe barrel to the hub of the VAD. The Luer connector also has a distal end channel for detachably attaching the Luer connector to the hub of the VAD, and a proximal end channel for detachably attaching the Luer connector to the barrel of the syringe.

[0040] As used herein, the term “syringe” refers to a simple pump-like device consisting of a plunger rod that fits securely into a barrel or tube. The plunger rod can be pulled or advanced along the inside of the barrel, allowing the syringe to draw in and expel liquid or gas through an opening at the open end of the barrel. In one or more embodiments, the syringe is a flush syringe filled with a flush solution.

[0041] References to “pre-filled syringe assemblies” include syringes in which the barrel is filled with a solution or drug during or after assembly using a sterile filling method prior to delivery to the user. “Pre-filled syringe assemblies” include syringe assemblies indicated for use in flushing vascular access devices (VADs).

[0042] As used herein, the term “medical device” refers to a general medical device having a threaded or interlocking connection, the connection having a corresponding connecting element. For example, a syringe may have a female Luer connector on a catheter, a male threaded connector that interlocks detachably with a secondary medical device such as an IV line. The threaded connector includes a lumen defining a flow path, enclosed by a protruding wall having threaded means for attachment to the secondary medical device.

[0043] As used herein, the term “disinfectant” includes antimicrobial agents.

[0044] Descriptive terms such as “thread,” “tab,” “wall,” “top,” “side,” and “bottom” are used throughout this specification for ease of understanding, so as to be easily understood by skilled artisans of the related art, but are not intended to limit any components that may be used in combination or individually to implement various aspects of the embodiments of this disclosure.

[0045] The examples provided in this description are provided to aid in a comprehensive understanding of the exemplary embodiments of this disclosure. Therefore, those skilled in the art should be aware that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of this disclosure. Furthermore, for clarity and brevity, descriptions of well-known functions and configurations are omitted. Before describing some exemplary embodiments of this disclosure, it should be understood that this disclosure is not limited to the configuration details or process steps specified in the following description. Other embodiments of this disclosure are possible and can be practiced or implemented in various ways.

[0046] Contact with surfaces can lead to contamination and bloodstream infections with potentially fatal consequences, so it is crucial to ensure that no device touches any surface. However, clinicians often need to handle multiple components while accessing venous (IV) lines or catheters, such as opening and disinfecting hubs, opening syringes, and holding lines in place. Therefore, accessing venous (IV) lines or catheters is not straightforward and requires a certain level of dexterity to perform the procedure while preventing the syringe tip from contacting the surrounding environment. If the syringe tip touches a non-sterile surface, "touch" contamination can occur, leading to microbial growth within the IV line and potentially resulting in highly costly and potentially fatal catheter-associated bloodstream infections ("CRBSI") and central line-associated bloodstream infections ("CLABSI").

[0047] Embodiments of the present disclosure relate to a disinfection unit comprising a pre-filled syringe assembly having two integrated disinfection units attached to a syringe. The disinfection unit provides means for mechanical and chemical disinfection, namely a scrubbing unit (such as a foam) and a chemical disinfectant (such as alcohol).

[0048] A flush syringe contains a flush solution, such as saline or other medication, throughout the product's shelf life, and allows for the delivery of this saline throughout use; that is, the syringe is connected to a hub (such as a needleless connector) and the contents of the syringe are delivered.

[0049] The disinfection unit provides a means of disinfecting the hub through mechanical and chemical disinfection. The disinfection unit contains a chemical disinfectant (such as 70% isopropyl alcohol) throughout the product's shelf life.

[0050] As described below, embodiments of the present disclosure enable the non-permanent coupling of a disinfection unit to a syringe unit for performing disinfection and subsequent flushing processes in a standard sash procedure. Embodiments of the present disclosure provide non-permanent mechanical means for coupling a disinfection unit to a syringe. Embodiments of the present disclosure engage the disinfection unit with the syringe tip or thumb press using threaded connectors or flexible elements (e.g., clips) on the syringe or disinfection unit during the assembly line. Threaded connectors or flexible elements, such as clips or tabs, may be disposed on either the disinfection unit or the syringe (engaging with a corresponding coupling mechanism on the other component, locking and preventing the disinfection unit and syringe tip cap from being attached and immediately detached until desired use by the clinician).

[0051] With reference to the drawings, the embodiments of this disclosure are described below, with reference numerals indicating the same or corresponding parts throughout several drawings.

[0052] In one or more embodiments, the assembly comprises a device of one or more embodiments connected to a medical connector. In one or more embodiments, the medical connector is selected from a male Luer connector, a female Luer connector, and a needleless connector.

[0053] Referring to Figures 1 to 15, a disinfection device assembly 100 connectable to a male or female medical connector, according to an exemplary embodiment of the present disclosure, also generally includes a syringe assembly 110, a needleless connector disinfection unit (NCDU) 130, and a male Luer disinfection unit (MLDU) 150. As shown in Figure 1, the syringe assembly 110 has a syringe barrel 111 having an elongated body 112 defining a chamber 115 for holding fluid. The syringe barrel 111 includes an open proximal end 113 having a flange 119 and a distal end 114 including a tip 121 having a passage 122 for fluid communication with the chamber. As shown in Figure 2, the distal end 114 of the barrel also includes a locking Luer-type collar 120 concentrically surrounding the tip 121. The locking Luer-type collar 120 has a female thread 123. The syringe assembly 110 further includes a stopper 116 connected to an elongated plunger rod 117 having a thumb press 118 at its open proximal end 113, the thumb press being integrally connected to the MLDU 150. The disinfection device assembly 100 further includes an NCDU 130 connected to a locking Luer-type collar 120 at its distal end 114.

[0054] Referring to Figures 2 to 5, the NCDU 130 comprises a proximal housing 134, a distal housing 135, a first closed proximal end 132, a first annular wall 136, and a second annular wall 137, the total length of which extends from the first closed proximal end 132 to a first open distal end 133 defining a first chamber 141 containing a first scrub foam 139, a first disinfectant 145 within the NCDU 130, and a first peelable seal 131 having a first upper web 143. The first scrub foam is immersed in the first disinfectant 145. The first open distal end 133 defines an engagement surface with respect to the first peelable seal 131. The proximal housing 134 has a plurality of vertical receiving grooves 198 arranged around the inner surface of the first annular wall 136 and a circumferential rib 202 arranged around the inner surface of the first annular wall 136. The distal housing 135 has a plurality of vertical alignment ribs 197 arranged around the outer surface of the second annular wall 137, configured to be received by the vertical receiving grooves 198, and a circumferential groove 201 arranged around the outer surface of the second annular wall 137, configured to receive the circumferential rib 202.

[0055] As shown in Figure 1, the syringe assembly 110 can be attached to the proximal housing 134 of the NCDU 130 by a mechanical connection mechanism. Once attached, the syringe assembly 110 and the proximal housing 134 of the NCDU 130 can withstand axial and radial disintegrating forces. To remove the proximal housing 134 of the NCDU 130 from the syringe assembly 110, the user should apply torque to the entire assembly, thereby detaching the NCDU 130 from the locking Luer-type collar 120 at the distal end 114 of the syringe barrel 111, allowing the flush syringe to be attached to the IV catheter line. When torque is applied to either the syringe barrel 111 or the proximal housing 134 of the NCDU 130, or both, the NCDU 130 will unthread off the syringe assembly 110.

[0056] Figure 6 shows a flowchart illustrating a needle-free connector disinfection process using NCDU according to an exemplary embodiment of the present disclosure.

[0057] Referring to Figures 7 and 8, the ML disinfection unit 150 comprises an integrated body 153, a second closed proximal end 151, and a second annular wall 167 having a length extending from the second closed proximal end 151 to a second open distal end 152 that defines the second chamber 168.

[0058] As shown in Figures 7 and 8, the ML disinfection unit 150 and the syringe assembly 110 are integrally mounted or interlocked through an interface mating, snap-fitting, or screw-fitting between the thumb press 118 of the syringe assembly 110 and the proximal wall 170 of the ML disinfection unit 150. The interlocking portion of the ML disinfection unit 150 may be located at the second closed proximal end 151 of the second annular wall 167 of the ML disinfection unit 150 to provide a snap-on connection to the thumb press 118.

[0059] Figure 7 is an exploded view of an ML disinfection unit 150 according to one or more embodiments of the present disclosure. Figure 8 shows a cross-sectional perspective side view of the ML disinfection unit 150. As shown in Figures 7 to 8, the ML disinfection unit 150 comprises an integrated body 153, a central post 173, a foam cover 155, a central plug 154, an outer scrub foam 156, and a first disinfectant 145.

[0060] Figure 7 shows an exploded perspective view of a male Luer disinfection unit (MLDU) according to an exemplary embodiment of the present disclosure, and Figure 8 shows a cross-sectional view of an MLDU according to an exemplary embodiment of the present disclosure. The MLDU 150 includes a one-piece body 153 having a second closed proximal end 151 including a proximal wall 170, a second open distal end 152 defining an opening 171 for receiving the hub of a male Luer connector, and a second annular wall 167 extending from the second closed proximal end 151 to the second open distal end 152. The second annular wall 167 of the one-piece body 153 is cylindrical and has a length extending from the second closed proximal end 151 to the second open distal end 152. The second closed proximal end 151, the second open distal end 152, and the second annular wall 167 define a second chamber 168 of the one-piece body 153 configured to receive the hub of a male Luer medical connector. In one or more embodiments, the second open distal end 152 includes a peripheral ledge 160 extending radially outward from the second open distal end 152, defining a sealing surface 172. An opening 171 is provided at the second open distal end 152 of the integrated body 153 to receive the hub of a male Luer connector.

[0061] The integrated body 153 can be made from many types of plastic materials, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the integrated body 153 comprises polypropylene or polyethylene material.

[0062] The ML disinfection unit 150 includes a central post 173 that extends from the center of the second closed proximal end 151 of the integrated body 153 and is disposed within the second chamber 168. In one or more embodiments, the central post 173 is molded as a single molded plastic within the integrated body 153.

[0063] In one or more embodiments, as shown in Figure 8, the central post 173 is integrated with or embedded in the bottom wall of the second chamber 168 of the integrated body 153. The central post 173 is located within the second chamber 168 of the integrated body 153, is basically cylindrical, and can be coaxial with the second annular wall 167. The inner surface of the proximal wall 170 can form the apex of the second chamber 168. In embodiments, the central post 173 is formed integrally with the integrated body 153. The central post 173 is formed integrally with the proximal wall 170 of the integrated body 153. In one or more embodiments, the central post 173 is molded within the integrated body 153 as a single molded plastic.

[0064] In one or more embodiments, the central plug 154 is coupled to the central post 173 by a ball-and-socket joint. The ball-and-socket joint at the base of the central plug 154 allows it to rotate freely around its axis.

[0065] In an alternative embodiment (not shown), the central post is attached to the proximal wall 170 of the integrated body 153, for example, by snap-fit ​​attachment.

[0066] The second cavity 162 of the integrated body 153 is defined by the inner surface 174 of the foam cover 155 disposed at the top of the central post 173. The central post 173 also has an outer surface 175. In one or more embodiments, the central post 173 also has an outer surface 175 sufficient to interlock with the connection mechanism of a male needleless connector. Such connectors are commonly and typically used in medical applications as protective connectors for catheters and other fluid seals. In one or more embodiments, the central post 173 can extend essentially from the inner surface of the proximal wall 170 toward the second open distal end 152 of the integrated body 153.

[0067] In one or more embodiments, the central post 173 may extend essentially parallel to the second annular wall 167 of the integrated body 153. The central post 173 may be made of plastic, thermoplastic elastomer (TPE), or a mixture of plastic (such as polypropylene (PP) or polyethylene (PE)) and TPE material. The central post 173 may be made from many types of plastic materials, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the central post 173 comprises polypropylene or polyethylene material.

[0068] A foam cover 155 extending from a central post 173, and the inner surface 174 of the foam cover 155, define a second cavity 162 disposed within a second chamber 168. The foam cover 155 is located within a hollow defined by an outer scrub foam 156, which in turn is located within a cavity defined by the inner surface of the central post 173. The foam cover 155 has inner and outer surfaces for engaging with a medical connector. In one or more embodiments, the foam cover 155 is made of a first absorbent material 147. In one or more embodiments, the first absorbent material 147 is a nonwoven material, foam, or sponge. In certain embodiments, the foam is polyurethane foam. In one or more embodiments, the top of the foam cover 155 extending beyond the top surface of the scrub foam includes one or more internal prongs 165 separated by one or more internal slits 166, which correspond to and are complementary to one or more prongs 125 separated by one or more slits 126 at the top of the center post 173. During assembly, a foam cover 155 having similar pre-cut protrusions formed by internal prongs 165 and internal slits 166, similar to the center post 173, can be positioned on top of the center post 173.

[0069] The central plug 154 is positioned in the center of the central post 173, extending from the top wall of the central post 173, and extends into the second cavity 162 of the foam cover 155. The central post extends from the inner surface to the bottom wall of the housing and can be formed integrally with the housing. The MLDU disclosed herein is advantageous because, by including the central plug, it minimizes the entry of disinfectants such as isopropyl alcohol and chlorhexidine into the central lumen of the medical connector.

[0070] The external shape of the central plug 154 is sufficiently complementary to open lumen luer connectors for engagement with male luer connectors. When the central plug 154 engages with the open lumen in a luer connector such as a catheter or stopcock, the complementary luer inner wall applies radial pressure to the insert, creating an interference fit. The bottom surface of the central plug 154 can cover the open lumen at the luer tip on the connector, thereby reducing the entry of disinfectants.

[0071] The central plug 154 may be made of a solid material that is soft enough to be compressed longitudinally, so that when the MLDU is attached to a male luer such as a needleless connector and an IV tube end, the central plug 154 may retract toward the top wall at the closed end of the cap housing, but is sufficiently rigid radially to form a good interference fit with open luers such as catheters and plugs.

[0072] According to established toxicology limits, the maximum permissible limit for 70% isopropyl alcohol (IPA) is 14.3 mg / kg / day. The maximum ingress limit per disinfectant cap can be calculated by dividing the maximum permissible limit of 70% IPA (14.3 mg / kg / day) by the total number of disinfectant caps used per day. For example, assuming a maximum of 16 caps are used per day and the worst-case patient is a premature newborn weighing 1 kg, the ingress limit would be 0.89 mg of 70% IPA per cap. The central plug 154 allows for minimizing, reducing, or ideally preventing IPA ingress through sealing by its cylindrical sides. The central plug 154 fits within the lumen of the male lure, thereby reducing / avoiding IPA ingress into the IV line. The central plug 154 keeps the central line of the male lure sealed, minimizing IPA ingress into the line. The ball and socket joint of the central plug allows the central plug 154 to rotate freely inside the male lure, thereby minimizing rotational resistance. The central plug 154 seals the IV line very well during disinfection, so it seals the IV line and minimizes the amount of disinfectant that enters the IV line. In one or more embodiments, the central post 173 is able to rotate freely around its axis by the ball and socket joint at its base.

[0073] The outer scrub form 156 is disposed within the second chamber 168. In one or more embodiments, during assembly, the outer scrub form 156 is in direct contact with the inner surface of the proximal wall 170. In one or more embodiments, the outer scrub form 156 is assembled within the central post 173.

[0074] In one or more embodiments, the outer scrub foam 156 is made of a second absorbent material 148. In one or more embodiments, the second absorbent material 148 is a nonwoven material, foam, or sponge. In certain embodiments, the foam is polyurethane foam.

[0075] A central post 173, extending from the second closed proximal end 151 of the integrated body 153 and located within the second chamber 168, supports the foam cover 155 and provides internal rigidity to the foam cover 155. In one or more embodiments, the top of the central post 173 extending beyond the top surface of the scrub foam includes one or more external prongs 163 separated by one or more respective external slits 164. In one or more embodiments, at least one of the external prongs 163 or external slits 164 may be configured to bend to facilitate interference fit between the central post and the connection mechanism of the male needleless connector. In one or more embodiments, the central post 173 may extend essentially from the inner surface of the proximal wall 170 toward the second open distal end 152 of the integrated body 153. In one or more embodiments, the central post 173 may extend essentially parallel to the second annular wall 167 of the integrated body 153.

[0076] The central post 173 also supports the outer scrub form 156 by centralizing and providing a fixed position for the outer scrub form 156, and also provides rigidity to the outer scrub form 156 disposed within the second chamber 168 of the integrated body 153 between the central post 173 of the integrated body 153 and the second annular wall 167.

[0077] As shown in Figures 7 and 8, in one or more embodiments, the outer scrub form 156 comprises a cylindrical body 231, a bottom end 233, and an annular wall 232 having a length extending from the bottom end 233 to an open top 234 defining a second chamber 168 containing a second disinfectant 146. The bottom end 233 of the outer scrub form 156 includes a peripheral ledge 236 that defines an end face 235 and extends radially inward from the annular wall 232 to contact the distal tip of the male luer connector 200, the peripheral ledge 236 having a central opening 237 formed to be positioned around a central post 173. The peripheral ledge 236 defines an engagement surface for the distal tip and outer surface of the male luer connector. In one or more embodiments, the outer scrub form 156 includes a plurality of external slits 164 that form external prongs 163 within the outer scrub form 156. In one or more embodiments, a plurality of external slits 164 are pre-cut in the body of the outer scrub foam 156 to effectively clean contaminated surfaces. In one or more embodiments, the plurality of external slits 164 of the outer scrub foam 156 are in the form of finger-like external prongs 163 configured for scrubbing. In one or more embodiments, the finger-like prongs are configured as projections or bristles. The outer scrub foam 156 is press-fitted into a first cavity 161, which, due to its surface tension and wettability properties, can also hold any disinfectant inside. The outer scrub foam 156 disinfects the outer wall surface of the male luer connector through scrubbing. The annular wall 232 has a slotted end formed by the external slits 164 and a non-slotted end. In one or more embodiments, the external slits 164 extend along the annular wall 232 to less than half its length. The external slit 164 allows the lure tip of the male lure connector to be inserted into the hollow cylindrical cavity, thereby allowing the sidewalls of the sponge to interact with the sides of the male lure connector and release the second disinfectant 146 onto the lure surface. The external slit 164 may open when the male lure connector is inserted into the MLDU 150 and the lure pushes aside both sides of the sponge, opening the groove.

[0078] The annular wall 232 of the outer scrub form 156 comprises an outer wall surface 232A and an inner wall surface 232B. The inner wall surface 232B defines an opening adjacent to the bottom end. The inner surface of the top of the outer scrub form 156, the outer surface of the foam cover 155, and the top surface of the peripheral ledge 160 define a concentric cavity. The top 234 of the side wall of the outer scrub form 156 includes a plurality of external slits 164 that are radially present around the top 234 of the outer scrub form 156 and extend from the upper end of the peripheral ledge 236 to the open top 234, which define a plurality of external prongs 163 around the open top 234 of the outer scrub form 156. The faces 238 of the external prongs 163 may be chamfered at the top end of the outer scrub form 156. The external prongs 163 have bottom ends defined by locations 156a where each of the external slits 164 terminates near the peripheral ledge 160. The external slits 164 provide gaps to which disinfectant can adhere, and also provide flexibility to each of the external prongs 163, thereby allowing the outer scrub foam 156 to slide along the outer surface of the male luer connector when a force along the central axis is applied along the inner surfaces of the foam cover 155 and the outer scrub foam 156, such as when the male luer connector is inserted into the ML disinfection unit (MLDU) 150.

[0079] In one or more embodiments, the foam cover 155 includes a plurality of internal slits 166 within the foam cover 155. In one or more embodiments, the plurality of internal slits 166 are pre-cut in the body of the foam cover 155 to effectively clean contaminated surfaces. In one or more embodiments, the plurality of internal slits 166 of the foam cover 155 are in the form of finger-shaped internal prongs 165 or projections configured for scrubbing. Disinfection of the threaded area of ​​the male luer is achieved when the foam cover 155, moistened with a second disinfectant 146, comes into contact with the side walls of the luer portion and the female threads within the male luer, scrubbing and cleaning these areas. Passive disinfection is achieved using an alcohol-impregnated catheter hub protective cap. The MLDU 150 includes an alcohol-impregnated sponge that can be attached to the male medical connector, thus protecting the access point from contamination and performing disinfection. Active disinfection is performed by using a wipe to mechanically loosen microorganisms, allowing the disinfectant to kill the microorganisms. This procedure is often referred to as "scrubbing the hub." Finger-like internal prongs 165 or projections within the foam cover 155 are used to scrub and disinfect the contaminated surface of the male luer connector. The foam cover 155 scrubs the front end face of the incoming male luer, the outer surface of the luer, and the threaded male luer. The center plug 154 is connected to the center post 173 by a ball-and-socket joint. The center plug 154 can rotate freely around its axis by a ball-and-socket joint at its base. The center post 173 supports the foam cover 155 and provides internal rigidity. The center post 173, lined with the foam cover 155 which has multiple bristly structures, enters the area between the tapered outer surface of the male luer and the threaded area of ​​the male luer connector. Through clockwise and counterclockwise rotation, these multiple bristle-like structures actively remove contaminants through a mechanical scrubbing action, and further disinfect and kill microorganisms through chemical disinfection by the disinfectant (IPA) present inside the cap.

[0080] When clockwise and counterclockwise rotation is achieved, the central plug 154 rotates together with the male connector via a ball and socket joint between the central plug 154 and the central post 173, while remaining firmly seated in the inner lumen. This prevents relative movement between the central plug 154 and the male connector, thus avoiding the entry of IPA into the IV line.

[0081] The foam cover 155, having pre-cut similar internal prongs 165 and internal slits 166 corresponding to the prongs 125 and slits 126 of the central post 173, allows the foam cover 155 to be positioned on top of the central post 173. Thus, the central post 173 provides rigidity to the foam cover 155. The central post 173 has a socket joint-like structure into which the central plug 154 is fitted (with specified tolerances), and so it remains fitted or fixed in place until it blocks the lumen of the incoming male luer connector. The foam cover 155 scrubs and disinfects the proximal tip, sidewalls, and female threaded area of ​​the male luer connector.

[0082] In one or more embodiments, the foam cover 155 comprises an integral cylindrical body, a bottom end, a top end, and an annular wall having a length extending from the bottom end to an open proximal end defining a second cavity containing a second disinfectant. The bottom end defines an end face and includes a peripheral ledge extending radially inward from the annular wall to contact the distal tip of a male Luer connector, the peripheral ledge having a central opening formed to accommodate a central plug. The peripheral ledge defines an engagement surface for the distal tip of the male Luer connector. The annular wall of the foam cover 155 comprises an outer wall surface and an inner wall surface. The inner surface of the top end of the foam cover 155 and the top surface of the peripheral ledge define a second cavity 162 containing a second disinfectant 146. The top of the side wall of the foam cover 155 includes a plurality of internal slits 166 that are radially present around the top of the foam cover 155 and extend from the upper end of the peripheral ledge to the open end, defining a plurality of internal prongs 165 around the top of the foam cover 155. The faces of the internal prongs 165 may be chamfered at the top of the foam cover 155. The internal prongs 165 have bottom ends defined by where each of the internal slits 166 terminates near the peripheral ledge 160. The internal slits 166 provide gaps to which disinfectant can adhere, and the internal slits 166 also provide flexibility to each of the internal prongs 165, thereby allowing the foam cover 155 to slide along the threads and outer surface of the male luer connector when a force along the central axis is applied along the inner surfaces of the foam cover 155 and the outer scrub foam 156, such as when the male luer connector is inserted into the ML disinfection unit (MLDU) 150. The annular wall extends between the grooved end formed by the internal slit 166 and the non-grooved end. In one or more embodiments, the internal slit 166 extends along the annular wall to approximately halfway. The internal slit 166 allows the lure tip of the male lure connector to be inserted into the hollow cylindrical cavity, thereby allowing the sidewalls of the sponge to interact with the threads and sides of the male lure connector to release disinfectant onto the lure surface. The internal slit 166 may open when the male lure connector is inserted into the MLDU and the lure pushes both sides of the sponge, opening the groove.

[0083] The central plug 154 is located within a hollow space defined by the outer scrub form 156, which in turn is located within a cavity defined by the inner surface of the central post 173.

[0084] In one or more embodiments, the outer surface shape of the outer scrub foam 156 and / or foam cover 155 may have tapered ends with angles within a range that can be sufficiently complementary to the male luer taper.

[0085] The second chamber 168 houses the outer scrub foam 156, the central plug 154, the central post 173, the foam cover 155, and the second disinfectant 146. In one or more embodiments, the second disinfectant 146 is filled into the second chamber 168 to wet the outer scrub foam 156 and the second cavity 162, and wet the foam cover 155, in order to disinfect the threads and outer surface of the male luer connector. In one or more embodiments, the second disinfectant 146 is isopropyl alcohol (IPA).

[0086] Passive disinfection is achieved using a disinfectant-impregnated outer scrub foam 156 and foam cover 155 housed in a first cavity 161 of the ML disinfection unit 150 that contacts the NFC, thus protecting the access point from contamination and performing disinfection. When the intermolecular surface tension of the second disinfectant 146 interacts with the pre-cut foam, the multiple finger-like internal prongs 165 and external prongs 163 in the bodies of the foam cover 155 and outer scrub foam 156 both hold IPA between the pre-cut structures, keeping the foam moist, and allowing liquid IPA to adhere to the foam protrusion structure due to surface tension in both the outer scrub foam 156 and the foam cover 155. Disinfection is based on the use of a foam cover 155 having similar external prongs 165 corresponding to the prongs 125 of the central post 173. The internal prongs 165 and external prongs 163 allow the outer scrub foam 156 and foam cover 155 to be constructed together. The surface tension between the foam covers 155 holds droplets of the second disinfectant 146 within the structure. When the foam covers 155 are inserted into the threaded portion of the male medical connector 200 and scrubbed, a combination of mechanical and chemical disinfection is achieved, making it possible to disinfect all external surfaces of the male lure. Recent studies have concluded that chemical disinfection alone is insufficient to achieve a 4-log reduction (99.99% reduction) of microorganisms. However, combining chemical disinfection with isopropyl alcohol (IPA), for example, with mechanical scrubbing to physically remove contaminants plays a crucial role in achieving a 4-log reduction.

[0087] The interaction between the multiple internal slits 166 and external slits 164, which result in finger-shaped internal prongs 165 and external prongs 163, and the surface tension properties of the second disinfectant 146 makes it possible to minimize the amount of liquid disinfectant, such as IPA, used for scrubbing. The liquid IPA adheres between the internal prongs 165 and external prongs 163 through the interaction of the foam protrusions and the second disinfectant 146, and adheres according to the following formula. W=2T Here, W is the weight of the liquid IPA adhering to the surface, and T is the surface tension of the liquid IPA from the foam's protrusions.

[0088] The integrated disinfection device assembly described herein can achieve disinfection when used on a male Luer connector by passive disinfection when the male Luer connector is inserted into the MLDU and comes into contact with a second disinfectant 146 that wets the foam cover 155 and the outer scrub foam 156, and by active disinfection when the male Luer connector rotates back and forth (clockwise and counterclockwise) in a twisting motion while maintaining contact with the multiple internal slits 166 of the foam cover 155 and the external slits 164 of the outer scrub foam 156. As shown in Figures 11-12, when the male medical connector 200 is inserted into the ML disinfection unit 150, the second disinfectant 146 comes into contact with the distal tip to provide initial passive disinfection. The male medical connector 200 is inserted into the ML disinfection unit 150, and the male medical connector 200 disinfects the outer surface and threads of the male Luer connector via active disinfection as it repeatedly rotates in clockwise and counterclockwise directions in a twisting motion. The twisting motion during the attachment of the MLDU and sponge allows the finger-like projections of the internal prongs 165 and multiple prongs 163 to come into contact with the female threads and outer surface of the male luer in a scrubbing action that contributes to the physical removal (i.e., cleaning) of microorganisms. Thus, this twisting motion increases the disinfectant activity compared to using 70% IPA alone. Therefore, the advantage of using the integrated disinfection device assembly of the present disclosure is that the MLDU of the present disclosure enables disinfection of the male luer connector by both chemical disinfectants (passive disinfection) and scrubbing action (active disinfection). Thus, the combination of passive and active disinfection results in improved disinfection results. Once disinfection is complete, the ML disinfection unit 150 does not remain connected to the male connector and can be discarded.

[0089] An integrated disinfection device assembly containing both NCDU and MLDU is designed to be compatible in interaction with various disinfectants. In one or more embodiments, the first disinfectant 145 or the second disinfectant 146 may include alcohol or a variation of chlorhexidine. In one or more embodiments, the first disinfectant 145 or the second disinfectant 146 is selected from the group essentially consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In certain embodiments, the first disinfectant 145 or the second disinfectant 146 comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the first disinfectant 145 or the second disinfectant 146 is a fluid or a gel.

[0090] In exemplary embodiments, a second peelable seal 157 can be provided to seal the opening 171 by attaching it, for example, to the sealing surface 172 of the second open distal end 152 of the integrated body 153 before use of the ML disinfection unit 150. In one or more embodiments, the second peelable seal 157 includes a peel-back top of aluminum or a multilayer polymer film including a peel tab 158. In certain embodiments, the second peelable seal 157 is heat-sealed or induction-sealed to the open end of the distal end. In one or more embodiments, the second peelable seal 157 includes a moisture-proof layer. According to exemplary embodiments of the present disclosure, the ML disinfection unit 150 can receive the tip or hub of a needleless connector into the second chamber 168, for example, after the peel seal sealing the cavity has been removed or when the second peelable seal 157 has been punctured. In one or more embodiments, a cap 159 is disposed on the second open distal end 152 of the integrated body 153.

[0091] Figure 4 shows a central plug 154 embedded in a central post 173. The central plug 154 has a substantially cylindrical body with a frustoconical top having a base wall, the base wall extending over the side wall 224 of the central plug 154. In one or more embodiments, the base wall 223 of the central plug 154 has a tapered surface. In one or more embodiments, the central plug 154 is fitted into an opening or channel at the center of the top wall of the central post 173.

[0092] Further aspects of the present disclosure relate to a method for disinfecting a medical connector. The method includes connecting an integrated disinfection device assembly of one or more embodiments to a medical connector, wherein the connecting step includes bringing the female medical connector into contact with the inner or outer surface of a first cavity of the NCDU and the male connector into contact with a second cavity of the MLDU, so that the medical connector comes into contact with a second absorbent material 148 and a second disinfectant 146 when the medical connector is inserted into the ML disinfection unit 150.

[0093] As shown in Figures 8 to 10, when in use, inserting the male medical connector 200 into the first cavity 161 and the second cavity 162 of the cap allows the connector to come into contact with the second disinfectant 146 disposed within the outer scrub foam 156 and foam cover 155, thereby supplying the disinfectant to the threads and outer surface of the male luer connector for disinfection. When the male medical luer connector is inserted into the ML disinfection unit 150, the central plug 154 first fits into the internal lumen of the luer and blocks this passage (entryway), preventing the second disinfectant 146 from the cap from penetrating and entering the internal lumen of the male luer connector. When the ML disinfection unit 150 is assembled with the male medical connector 200, the lumen edge of the male Luer connector compresses the foam cover 155 and outer scrub foam 156 toward the proximal wall 170 of the second closing proximal end 151 of the integrated body 153, allowing the second disinfectant 146 to be supplied onto the threads and outer surface of the male Luer connector. When the central plug 154 engages with the open lumen, a complementary inner wall, e.g., the Luer wall, applies radial pressure to the central plug 154, forming an interference fit with the inner wall of the male Luer connector, thereby reducing and / or preventing the entry of disinfectant into the lumen.

[0094] The outer scrub foam 156 conforms to the outer body of the male IV connector and cleans the collar through mechanical and chemical action.

[0095] The exemplary caps of this disclosure allow for continuous disinfection of the connector and minimize the entry of microbial elements.

[0096] The exemplary MLDU 150 engages with a male Luer connector, and when a cap is attached to the male Luer connector, the male Luer connector is inserted into the second cavity 162. After the connector is inserted into the second cavity 162 of the exemplary MLDU 150, the disinfectant from the disinfectant sponge comes into contact with the male Luer connector. After disinfecting the male connector, the ML disinfection unit 150 is no longer connected to the male connector and can be discarded.

[0097] Further aspects of the present disclosure relate to assemblies, which comprise caps of one or more embodiments connected to medical connectors. In one or more embodiments, the medical connectors are male Luer connectors or needleless connectors.

[0098] A ledge / wedge portion may be provided at the second closing proximal end 151 of the second annular wall 167 of the integrated body 153 to provide a snap-on connection to the thumb press 118. The inner surface of the top wall provided at the second closing proximal end 151 of the second annular wall 167 of the integrated body 153 may have a recess into which the insert's ledge / wedge can be inserted.

[0099] In one or more embodiments shown in Figures 1 to 3, the mechanical connection and assembly features ensure that the device can be assembled in an automated process, guaranteeing the integrity of the device during transport, in use, and throughout the product's shelf life. The assembly with the NCDU 130 of this disclosure via mechanical or threaded connections and the locking luer-type collar 120 of the syringe assembly 110 facilitates high-speed, automated assembly.

[0100] Compared to currently available individual flash syringe and disinfection unit products, embodiments of the disinfection device assembly 100 of this disclosure provide easier access to multiple disinfection products in each flash and easier manual operation between subsequent flashes of disinfection.

[0101] In one or more embodiments, the disinfection device assembly 100 includes a connecting element that enables the syringe to be connected to the NCDU 130 and the ML disinfection unit 150. In one or more embodiments, the connecting element includes a threaded connector, for example, a Luer threaded connector that enables the syringe assembly 110 to be connected to the NCDU 130. In exemplary implementations of embodiments of the present disclosure, the disinfection device assembly 100 includes an integrated thread or tab, and other features in any and all combinations, that enable the proximal housing 134 to connect to a threaded fitting of a medical device. In one or more embodiments, the syringe assembly 110 can be attached to the proximal housing 134 of the NCDU 130 using a variety of methods, including but not limited to mechanical fasteners, snap fittings, and threaded connections. In one or more embodiments, the threaded connector is disposed on the bottom outer surface of the proximal housing 134 of the disinfection device assembly 100 and has threads formed and developed to engage with the threads of a locking Luer-type collar 120 on the distal end 140 of the syringe barrel 111, enabling the assembled disinfection device assembly 100 to be connected to a syringe. As shown in Figures 2-3, in one or more embodiments, the first annular wall 136 of the proximal housing 134 of the NCDU 130 includes a threaded post 138 disposed at the center of the first annular wall 136 of the proximal housing 134, which connects to the corresponding female thread 123 of the locking Luer-type collar 120 on the distal end 114 of the syringe barrel 111. As shown in Figures 10-13, there are multiple embodiments of the disinfection device assembly 100, in which the ML disinfection unit 150 and the syringe assembly 110 are connected through a number of fittings, including interference fits, snap fits and screw fits, and for the ML disinfection unit 150 onto the thumb press 118 of the syringe assembly 110.

[0102] In one or more embodiments, as shown in Figures 4 and 5, the plunger rod 117 includes an MLDU 150 attached to or incorporated into the plunger rod for disinfecting male medical connectors. These scrubbing devices disinfect the connectors (male and / or female) and are then discarded after use. In an alternative embodiment, the ML disinfection unit 150 is adapted to fit on a thumb press 118 of an elongated plunger rod 117, opposite the tip 121. Referring to Figure 15, in one or more embodiments, the ML disinfection unit 150 may be connected to the thumb press 118 using a rim disposed on a peripheral ledge 160 and radially inwardly disposed rim to create a lip or rim. The inner surface of the peripheral ledge 160 on the inner annular wall surface of the ML disinfection unit 150 at the second closed proximal end 151 includes at least two or more connecting projections 192 that allow the thumb press to connect with the ML disinfection unit 150 via a snap-fit ​​connection. In one or more embodiments, the snap-fit ​​connection comprises a protruding edge 187, a clip 188, and a snap-in area 189. The protruding edge 187 may be located on the inner surface of the peripheral side wall of the peripheral ledge 160, or on the inner annular wall surface of the ML disinfection unit 150 at the second closed proximal end 151, and the corresponding snap-in area is located on the surface opposite to the protruding edge 187 so as to enable the protruding edge 187 and the snap-in area 189 to interlock.

[0103] In one or more embodiments, the clip 188 is configured as a locking mechanism, thereby becoming a one-way flexing clip 188 that requires relatively little axial force to assemble and produces high locking strength. When the ML disinfection unit 150 and the thumb press 118 are attached, the clip 188 flexes inward until it fits into the thumb press 118 on the elongated plunger rod 117. Once contact is made between the clip 188 and the thumb press 118, the clip 188 springs or deflects outward, creating a connection between the thumb press 118 and the ML disinfection unit 150. The clip 188 flexes inward toward the integrated body 153 of the MLDU 150. Once the clip 188 clears over the thumb press 118, the clip 188 springs outward, creating a permanent connection between the two parts without the use of adhesive.

[0104] As shown in Figure 12, in one or more alternative embodiments, a removable male luer scrubbing device is attached to the thumb press of the plunger rod. As shown in Figure 12, mechanical locking is achieved by using a projecting trapezoidal locking rib 182 and a corresponding receiving undercut 181. In one or more embodiments, the integrated ML disinfection unit 150 has a trapezoidal locking rib 182 projecting across the second closed proximal end 151 of the MLDU 150, corresponding to a receiving undercut 181 disposed across the face of the thumb press 118 of the present disclosure.

[0105] As shown in Figure 13, in one or more alternative embodiments, a removable male lure scrubbing device is fitted inside a receiving cup integrally mounted to the proximal end of the plunger rod. As shown in Figure 13, in one or more alternative embodiments, mechanical locking is achieved by using alignment ribs 190 arranged along the outer edge of the integrated body 153 of the MLDU 150. In certain embodiments, the integrated MLDU 150 is press-fitted into a corresponding receiving cup 183 integrally mounted to the proximal end of the plunger rod. In one or more embodiments, the user may apply distal force to the structure of the receiving cup to push the plunger rod toward the distal tip of the barrel. In one or more embodiments, the receiving cup 183 has a corresponding receiving groove 191 for receiving the alignment ribs 190 and fitting the MLDU 150.

[0106] As shown in Figure 14, in one or more alternative embodiments, the removable MLDU 150 may be screwed onto the plunger rod. As shown in Figure 14, mechanical locking is achieved by using a locking taper 184. In a particular embodiment of the MLDU 150 with the thumb press 118 of this disclosure, the MLDU 150 includes a locking taper projecting proximal outward from a second closed proximal end 151. The locking taper 184 includes a taper receiver 185, which locks the MLDU 150 to the thumb press 118 when rotatably engaged with the grooved surface 186 of the thumb press 118.

[0107] As shown in Figure 15, the removable MLDU 150 may snap onto the plunger rod. As shown in Figure 15, the MLDU 150 and the syringe assembly are interlocked through an interference fit or snap-fit ​​between the thumb press 118 of the plunger rod 117 and the protruding edge 187 of the MLDU. To provide a snap-on connection to the thumb press 118, a ledge / wedge portion may be located at the closed end of the annular wall of the MLDU. The inner surface of the upper wall located at the closed end of the annular wall of the MLDU 150 may have a recess into which the rim of the thumb press can be inserted.

[0108] The closed end defines an end face that includes a projecting edge 187 extending radially outward from the annular wall.

[0109] The MLDU 150 is adapted to snap-fit ​​onto the thumb press 118 of the plunger rod 117. Referring to Figure 15, in one or more embodiments, the MLDU 150 may be connected to the thumb press 118 using a rim disposed on the peripheral ledge and radially inward to create a lip or rim. In one or more alternative embodiments, the inner surface of the peripheral ledge on the inner annular wall surface of the MLDU at the closed end includes at least two or more connecting projections 192 that enable the thumb press to connect with the MLDU via a snap-fit ​​connection. In one or more embodiments, the snap-fit ​​connection comprises a protruding edge and a snap-in area. The protruding edge may be disposed on the peripheral side wall of the peripheral ledge or on the annular wall surface of the MLDU at the closed end, and the corresponding snap-in area is disposed on the surface opposite to the protruding edge so as to enable the protruding edge and the snap-in area to interlock.

[0110] When the MLDU 150 and the thumb press 118 are assembled, the second closing proximal end 151 of the MLDU 150 is oriented to face the upper end of the thumb press 118. Specifically, during the assembly of the MLDU 150 and the thumb press 118, the second closing proximal end 151 of the MLDU 150 is inserted into the thumb press 118. Once the assembly is complete, mechanical connections prevent the MLDU 150 from being removed from the thumb press 118 by pulling the components apart.

[0111] NCDU130 can achieve disinfection when used on a needle-free connector ("NFC") by integrating a first disinfectant 145 into a first absorbent material 147 disposed and housed in a first chamber 141 of the proximal housing 134. The first disinfectant 145 can be directly incorporated into the first chamber 141 and absorbed into the first absorbent material 147 filling the chamber of the proximal housing 134. NCDU130 is designed to be compatible in interaction with various disinfectants. In one or more embodiments, the first disinfectant 145 may include alcohol or a variation of chlorhexidine. In one or more embodiments, the first disinfectant 145 is selected from the group essentially consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In certain embodiments, the first disinfectant 145 comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the first disinfectant 145 is a fluid or a gel.

[0112] The first absorbent material 147 absorbs the first disinfectant 145 contained in the first chamber 141 of the proximal housing 134. In one or more embodiments, the first absorbent material 147 is a nonwoven fabric, foam, or sponge. In certain embodiments, the foam is polyurethane foam.

[0113] A first peelable seal 131 having a first upper web 143 is disposed on the engaging surface 144 of the distal housing 135 to prevent the first absorbent material 147 from leaving the first chamber 141. A second peelable seal 157 having a peel tab 158 is disposed on the sealing surface 172 of the integrated body 153. To seal the NCDU 130 with the first absorbent material 147 properly inserted into the first chamber 141 of the proximal housing 134, the first peelable seal 131 can be fixed to the engaging surface 144 of the first open distal end 133 of the distal housing 135.

[0114] The first peelable seal 131 and the second peelable seal 157 minimize the entry of potential particulate hazards, provide a substantially impermeable enclosure to the NCDU 130 and MLDU 150, provide a leak-proof and protective enclosure, protect the contents of the first absorbent material 147 contained within the first chamber 141 and the second chamber 168, and / or maintain a sealed sterile environment. The first peelable seal 131 provides a sufficient seal within a certain range of temperature, pressure, and humidity levels. The first peelable seal 131 and the second peelable seal 157 may be positioned at the first open distal end 133 of the distal housing 135 and the second open distal end 152 of the integrated body 153 to prevent the pre-filled disinfectant 142 from escaping from the chambers of the NCDU 130 or MLDU 150.

[0115] The first peelable seal 131 and the second peelable seal 157 may be aluminum sealed with plastic and can be chemical resistant, light-shielding, impermeable, or sterile. In one or more embodiments, the first peelable seal 131 and the second peelable seal 157 include a peel-back top of aluminum or a multilayer polymer film. In certain embodiments, the first peelable seal 131 and the second peelable seal 157 are heat-sealed or induction-sealed to the engaging surface of the first open distal end 133 for sealing the NCDU 130 and to the second open distal end 152 for sealing the ML disinfection unit 150, respectively. In one or more embodiments, the first peelable seal 131 and the second peelable seal 157 include a moisture-proof layer.

[0116] After the connectors are inserted into the first open distal end 133 and the second open distal end 152 of the first chamber 141 and the second chamber 168, the first absorbent material 147 and the first disinfectant 145 come into contact with the male Luer connector, the female Luer connector, and the hemodialysis connector.

[0117] In one or more embodiments, the female connector may be selected from a group that essentially consists of needle-free connectors, catheter Luer connectors, stopcocks, and hemodialysis connectors. In one or more embodiments, the male medical connector 200 may be an intravenous tube end, a stopcock, or a male lock Luer.

[0118] The proximal housing 134, distal housing 135, and integrated body 153 are made from any type of plastic material, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the proximal housing 134, distal housing 135, and integrated body 153 are made of polypropylene or polyethylene material.

[0119] To avoid having to use different types of disinfection caps to clean different types of connectors, the disinfection device assembly 100, equipped with NCDU 130 and ML disinfection unit 150, is also compatible with and engages with male and female Luer connectors, thereby allowing the user to clean different types of connectors with a single device. When the NCDU 130 and ML disinfection unit 150 are attached to a female or male Luer connector, the female or male medical connector 200 engages with the inner wall upon insertion into either the first chamber 141 or the second chamber 168, and comes into contact with the first absorbent material 147 and the second absorbent material 148, which are immersed in the first disinfectant 145 and the second disinfectant 146. Thus, the device of this disclosure can disinfect both male and female Luer connectors, thereby meeting the current needs in the art.

[0120] Other aspects of the present disclosure relate to methods for disinfecting medical connectors and assemblies. In one or more embodiments, a method for disinfecting a medical connector includes connecting a device of one or more embodiments to a medical connector, the connection including frictionally engaging the inner wall surfaces upon insertion into a chamber so that the medical connector comes into contact with a first absorbent material 147 and a first disinfectant 145.

[0121] During use, the clinician snaps off and removes the NCDU130 from the syringe assembly and places the NCDU130 on a sterile tray for subsequent use of a sealed ML disinfection unit 150 to disinfect the NFC before flushing. As described above, the snapping mechanism on the underside of the scrubbing device separates the elongated plunger rod 117 of the syringe assembly 110 from the thumb press. The clinician peels off the first upper web 143 of the first peelable seal 131 from the distal housing 135. The clinician then disinfects the NFC using the distal housing 135 before flushing the IV line. When the NFC is inserted into the NCDU130, the first absorbent material 147 immersed in the first disinfectant 145 comes into contact with the NFC. Next, the clinician applies torque to the entire assembly, thereby removing the NCDU 130 from the syringe barrel by detaching it from the locking Luer-type collar 120 at the distal end 114 of the syringe barrel 111, and thus removing the proximal housing 134 of the NCDU 130 from the syringe barrel, allowing the flush syringe to be attached to the IV catheter line for flushing the IV line. When torque is applied to either the syringe or the proximal housing 134, or both, the proximal housing 134 of the NCDU 130 should unthread off from the barrel. The clinician then engages the threads of the locking Luer-type collar 120 on the distal end 114 of the syringe barrel 111 with the NFC in order to connect the NFC to the flush syringe. After flushing, the clinician picks up the removed NCDU130, peels off the first peelable seal 131 from the distal housing 135 to expose the first absorbent material 147 which has been immersed in the first disinfectant 145 after flushing the IV line, inserts the NFC connector into the distal housing 135, and disinfects the NFC using the distal housing 135 by bringing the second absorbent material 148 which has been immersed in the second disinfectant 146 into contact with the male Luer connector, female Luer connector, and hemodialysis connector.In current practices, the clinician then administers the medication, performs a second flush of the IV line using a flush syringe to remove any remaining medication from the catheter, and scrubs the hub using an antiseptic wipe or scrubbing device. The clinician then "locks" the IV line using a heparin flush or a lock syringe filled with 4% sodium citrate to help prevent clot formation within the catheter. Finally, a new ML disinfection unit 150 is attached to the indwelling catheter hub.

[0122] As previously mentioned, current products and SASH practices do not address cleaning after the initial flushing process, as sanitization ends after the initial flush. The advantage of embodiments of the present invention, which include two individually packaged NCDU130 and ML disinfection units 150, each having absorbent material (147, 148) into which disinfectant is applied, is a two-stage sanitization system that provides further protection to the patient by including an additional cleaning step using IPA or NCDU130 to sanitize the hub or connection interface before administration of the drug or locking solution, thereby further preventing potential infection to the patient.

[0123] When using the NCDU130, connecting it to a female or male Luer connector compresses the first absorbent material 147 toward the first closed proximal end 132 of the first chamber 141, allowing the connector to come into contact with the first disinfectant 145 and disinfect the female or male Luer connector.

[0124] Embodiment The following are numbered embodiments. It will be understood that the embodiments listed below can be combined with all aspects and other embodiments within the scope of the present invention.

[0125] Embodiment A. A disinfection device assembly comprising: a one-piece body having a closed proximal end, a proximal wall, an open distal end defining an opening, an annular wall extending from the closed proximal end to the open distal end, and a first cavity configured to receive a hub of a male medical connector; an outer scrub foam disposed within the first cavity; a central post extending from the proximal wall of the one-piece body and located within the first cavity; a foam cover disposed on the central post and defining a second cavity; a central plug disposed at the center of the central post, extending from the top wall of the central post and extending into the second cavity of the foam cover; a second disinfectant or antimicrobial agent, or a combination thereof; a peelable seal disposed on a sealing surface along the open distal end of the one-piece body; and a rigid upper web end cap disposed above the peelable seal.

[0126] Embodiment B. A disinfection device assembly of Embodiment (a), wherein when the MLDU is engaged with the male medical connector, the outer scrub foam and foam cover come into contact with the threads and outer surface of the male medical connector.

[0127] Embodiment C. A disinfection device assembly of Embodiment (b), wherein when the lumen of the male medical connector is open to the MLDU, the central plug enters the lumen and prevents the disinfectant from entering the lumen.

[0128] Embodiment D. A disinfection device assembly of Embodiment (a), wherein the outer scrub foam comprises an annular wall having slot ends formed by a plurality of outer slits and a plurality of outer prongs.

[0129] Embodiment E. A disinfection device assembly of Embodiment (a) 1, wherein the foam cover comprises an annular wall having slot ends formed by a plurality of internal slits and a plurality of internal prongs.

[0130] Embodiment F. A disinfection device assembly of Embodiment (a), wherein the central post comprises an annular wall having a plurality of slits and a plurality of prongs forming a slot end.

[0131] Embodiment G. A disinfection device assembly of Embodiment (a), wherein the central plug is disposed in the central opening of the central post, which extends from the top wall of the central post, and extends into the second cavity of the foam cover.

[0132] Embodiment H. A disinfection device assembly of Embodiment (a), wherein when the male medical connector enters the first cavity and the second cavity, the foam cover is in contact with the front tip surface of the luer, the outer surface, and the female thread of the male medical connector.

[0133] Embodiment I. A disinfection device assembly of Embodiment (a), wherein when the male medical connector enters the first cavity and the second cavity, the outer scrub foam is in contact with the front tip surface of the male medical connector and the outer luer surface.

[0134] Embodiment J. A disinfection device assembly of Embodiment (a), wherein the central plug and central post are joined by a ball-and-socket joint.

[0135] Embodiment K. A disinfection device assembly of Embodiment (a), wherein the outer geometry of the central plug includes a frustoconical tapered surface that is effective in complementing the inner surface of the lumen of the medical connector.

[0136] Embodiment L. A disinfection device assembly of Embodiment (a), wherein the integrated body comprises a polymer material selected from the group consisting of polyethylene, polypropylene, thermoplastic elastomer (TPE), or a combination thereof.

[0137] Embodiment M. A disinfection device assembly of Embodiment (a), wherein the male medical connector includes a male Luer connector.

[0138] Embodiment N. A disinfection device assembly of Embodiment (a), wherein the second disinfectant or antimicrobial agent is selected from the group essentially consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

[0139] Embodiment O. A disinfection device assembly of Embodiment (a), wherein a single body is joined to the thumb press of a syringe assembly by connecting a trapezoidal locking rib to a corresponding trapezoidal receiving undercut within the thumb press.

[0140] Embodiment P. A disinfection device assembly of Embodiment (a), wherein the integrated body is bonded to the thumb press of the syringe assembly by press-fitting the integrated body into a concentric receiving cup located above the thumb press surface of the syringe assembly.

[0141] Embodiment Q. A disinfection device assembly of Embodiment (a), wherein the integrated body is coupled to the thumb press of the syringe assembly by rotationally engaging the grooved surface of the thumb press with the tapered receiver of the integrated body.

[0142] Embodiment R. A disinfection device assembly of Embodiment (a), wherein the integrated body is coupled to the thumb press by snapping a rim, which is disposed on a peripheral ledge on the proximal wall of the integrated body, to the surface of the thumb press of the syringe assembly.

[0143] Embodiment S. A disinfection device assembly of Embodiment (n), wherein the second disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

[0144] Embodiment T. A disinfection device assembly of Embodiment (a), wherein the central post is integrally formed with the proximal wall of the integrated body.

[0145] Embodiment U. A disinfection device assembly of Embodiment (d), wherein a second disinfectant or antimicrobial agent is adhering between a plurality of outer slits and a plurality of outer prongs.

[0146] Embodiment V. A method for disinfecting a medical connector includes the step of positioning the disinfection device assembly of claim (a) on a male medical connector by bringing the distal tip and threads of the medical connector into contact with the outer scrub foam and foam cover, wherein the central plug prevents the disinfectant from entering the lumen of the medical connector.

[0147] Embodiment W. A medical assembly comprising a disinfection device assembly of claim (a) connected to a medical connector having a male Luer connector.

[0148] Embodiment X. A method for manufacturing a disinfection device assembly by connecting a disinfection device assembly to the proximal end of a syringe assembly by engaging a tip cap with the threading of a threaded locking luer-type collar of a syringe and attaching the integrated body of an ML disinfection unit to the thumb press surface on an elongated plunger rod, thereby connecting a scrubbing device to the distal end of a syringe assembly.

[0149] Embodiments of the present disclosure meet current needs by providing a device that disinfects the threaded area of ​​a male luer connector using both passive and active disinfection, while simultaneously reducing or avoiding the entry of disinfectant fluid into the male lumen.

[0150] While this disclosure has been shown and described with reference to its particular exemplary embodiments, it will be understood by those skilled in the art that various modifications can be made in form and detail without departing from the spirit and scope of the embodiments of this disclosure. For example, the disinfectant sponge may contain any suitable disinfectant or other specific application substance and may be made of any suitable material. Furthermore, any feature or element of any exemplary implementation of the embodiments of this disclosure described above and shown in the drawings may be implemented individually or in any combination without departing from the spirit and scope of the embodiments of this disclosure, as will be readily understood by those skilled in the art.

[0151] In addition, the included drawings further illustrate non-limiting examples of implementations of specific exemplary embodiments of the present disclosure and are useful for describing the related technology. Any specific or relative dimensions or measurements provided in the drawings, except as otherwise stated above, are illustrative and are not intended to limit the scope or content of any original design or technique as understood by those skilled in the art of the relevant invention.

[0152] Other purposes, advantages, and key features of this disclosure will become apparent to those skilled in the art from the details provided, and these details, in conjunction with the accompanying drawings, disclose exemplary embodiments of this disclosure.

[0153] In one or more embodiments, the assembly comprises a device of one or more embodiments connected to a medical connector. In one or more embodiments, the medical connector is selected from a male Luer connector, a female Luer connector, and a needleless connector.

[0154] Other aspects of the present disclosure relate to methods for disinfecting medical connectors and assemblies. In one or more embodiments, a method for disinfecting a medical connector includes connecting a device of one or more embodiments to a medical connector, the connection including frictionally engaging the inner wall surfaces of the medical connector upon insertion into a chamber so that the medical connector comes into contact with an absorbent material and a disinfectant.

[0155] While this disclosure has been shown and described with reference to its particular exemplary embodiments, it will be understood by those skilled in the art that various modifications can be made in form and detail without departing from the spirit and scope of the embodiments of this disclosure. Furthermore, the inner and / or outer housing of the cap can be single-shot molded or manufactured by other suitable processes. Moreover, any feature or element of any exemplary implementation of the embodiments of this disclosure described above and shown in the drawings can be implemented individually or in any combination without departing from the spirit and scope of the embodiments of this disclosure, as will be readily understood by those skilled in the art.

[0156] In addition, the included drawings further illustrate non-limiting examples of implementations of specific exemplary embodiments of the present disclosure and are useful for describing the related technology. Any specific or relative dimensions or measurements provided in the drawings, except as otherwise stated above, are illustrative and are not intended to limit the scope or content of any original design or technique as understood by those skilled in the art of the relevant invention.

[0157] Other purposes, advantages, and key features of this disclosure will become apparent to those skilled in the art from the details provided, and these details, in conjunction with the accompanying drawings, disclose exemplary embodiments of this disclosure.

[0158] Throughout this specification, any reference to “one embodiment,” “a particular embodiment,” “one or more embodiments,” or “a certain embodiment” means that any specific function, structure, material, or feature described in relation to that embodiment is included in at least one embodiment of this disclosure. Therefore, any other instances of phrases such as “in one or more embodiments,” “a particular embodiment,” “in one embodiment,” or “in a certain embodiment” throughout this specification do not necessarily refer to the same embodiment of this disclosure. Furthermore, any particular function, structure, material, or feature may be combined in any suitable manner in one or more embodiments.

[0159] While the disclosures herein have been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the disclosure. It will be apparent to those skilled in the art that various modifications and changes can be made to the methods and apparatus of the disclosure without departing from the spirit and scope of the disclosure. Therefore, the disclosure is intended to include modifications and changes that fall within the scope of the appended claims and their equivalents.

Claims

1. A disinfection device assembly, A needleless connector disinfection unit (NCDU) having a proximal housing, a distal housing, a first closed proximal end, and a first annular wall extending from the first closed proximal end to a first open distal end and defining a first chamber containing a first absorbent material and a first disinfectant, wherein the first open distal end extends radially inward from the first open distal end and has a peripheral ledge defining an end face and an engaging surface, To prevent the first disinfectant from leaving the first chamber, a first peelable seal is provided on the end face of the distal housing, A connecting element disposed at the center of the first closed proximal end of the NCDU, A flush syringe and A male Luer disinfection unit (MLDU) comprising a single body including a second closed proximal end, a proximal wall, a second open distal end defining an opening, a second annular wall extending from the second closed proximal end to the second open distal end defining a second chamber, and a first cavity configured to receive a hub for a male medical connector, A scrub foam is disposed within the first cavity, A central post extending from the proximal wall of the integrated body and located inside the first cavity, A foam cover is provided on the aforementioned central post and defines a second cavity, A central plug is disposed on the central post and extends into the second cavity of the foam cover, To prevent the disinfectant from leaving the second chamber, a second peelable seal is provided on the sealing surface of the integrated body, Liquid disinfectants or microbial factors, or combinations thereof A male lure disinfection unit (MLDU) having and A disinfection device assembly comprising the above.

2. The disinfection device assembly according to claim 1, wherein the connecting element is a threaded post.

3. The disinfection device assembly according to claim 2, wherein the connecting element is a Luer lock collar.

4. The disinfection device assembly according to claim 2, wherein the threaded post connects to the Luer lock collar of the flash syringe.

5. The disinfection device assembly according to claim 1, wherein the peripheral ledge is formed to accommodate and fit the thumb press of the plunger rod.

6. The disinfection device assembly according to claim 1, wherein the proximal housing and the distal housing are made of polypropylene or polyethylene material.

7. The disinfection device assembly according to claim 1, wherein the first absorbent material is a foam.

8. The disinfection device assembly according to claim 7, wherein the first absorbent material is polyurethane foam.

9. The disinfection device assembly according to claim 1, wherein the first absorbent material is a sponge.

10. The disinfection device assembly according to claim 1, wherein the first absorbent material has a slit.

11. The disinfection device assembly of claim 1, wherein the compression of the first absorbent material with respect to the first closed proximal end of the first chamber occurs when connecting to a medical connector.

12. The disinfection device assembly of claim 11, wherein contact with the first absorbent material disinfects the medical connector.

13. The disinfectant device assembly of claim 1, wherein the liquid disinfectant is selected from the group essentially consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chlorooxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

14. The disinfectant device assembly of claim 13, wherein the liquid disinfectant comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

15. The disinfection device assembly according to claim 13, wherein the liquid disinfectant is a fluid or a gel.

16. The disinfection device assembly of claim 1, wherein the first peelable seal and the second peelable seal each include a peel-back top of aluminum or a multilayer polymer film.

17. The disinfection device assembly according to claim 1, wherein the first peelable seal and the second peelable seal are heat-sealed or induction-sealed to the engaging surface and the sealing surface, respectively.

18. The disinfection device assembly of claim 1, connected to a syringe assembly, comprising: a syringe barrel having an elongated body defining a chamber; a flange; an open proximal end having a distal end having a tip having a passage for fluid communication with the chamber; a stopper connected to an elongated plunger rod having a thumb press at the proximal end; and a locking Luer-type collar on the distal end of the syringe barrel, The needleless connector disinfection unit (NCDU) is connected to the locking Luer-type collar on the distal end of the syringe barrel, The male luer disinfection unit (MLDU) connected to the thumb press of the elongated plunger rod of the syringe assembly and An assembly that includes this.

19. A method for disinfecting a medical connector, comprising the step of connecting the assembly of claim 18 to a medical connector, wherein the step of connecting is: The steps include peeling the upper web of the first peelable seal from the distal housing, The steps include inserting the needleless connector into the first chamber of the NCDU and bringing the needleless connector into contact with the first absorbent material immersed in the first disinfectant, The steps include: removing the proximal housing of the NCDU from the syringe barrel by applying torque on the assembly, and thus removing the proximal housing from the locking luer-type collar at the distal end of the barrel; The steps include: attaching the flush syringe to the IV catheter line by engaging the threads of the Luer lock collar on the distal end of the syringe barrel to connect the NFC to the flush syringe, and flushing the IV catheter line; The steps include removing the flash syringe from the NFC, peeling the upper web from the distal housing to expose the second absorbent material immersed in the second disinfectant, The steps include inserting the male Luer connector into the chamber of the distal housing of the MLDU and bringing the male Luer connector into contact with the second absorbent material immersed in the second disinfectant, Methods that include...

20. The disinfection device assembly according to claim 1, wherein when the MLDU engages with the male medical connector, the scrub foam and the foam cover come into contact with the threads and outer surface of the male medical connector.

21. The disinfection device assembly of claim 20, wherein when the lumen of the male medical connector is open to the MLDU, the central plug enters the lumen and prevents the entry of disinfectant into the lumen.

22. The disinfection device assembly according to claim 1, wherein the scrub foam comprises an annular wall having a plurality of slits and a plurality of prongs forming a slot end.

23. The disinfection device assembly according to claim 1, wherein the foam cover comprises an annular wall having a plurality of slits and a plurality of prongs forming a slot end.

24. The disinfection device assembly according to claim 1, wherein the central post comprises an annular wall having a slot end formed by a plurality of slits and a plurality of prongs.

25. The disinfection device assembly according to claim 1, wherein the central plug is disposed in the opening of the central post and extends into the second cavity of the foam cover.

26. The disinfection device assembly according to claim 1, wherein when the male medical connector enters the first cavity and the second cavity, the foam cover contacts the front tip surface of the luer, the outer surface, and the female thread of the male medical connector.

27. The disinfection device assembly according to claim 1, wherein when the male medical connector enters the first cavity and the second cavity, the scrub foam contacts the front tip surface of the male medical connector and the outer luer surface.

28. The disinfection device assembly according to claim 1, wherein the central plug is joined to the central post by a ball and socket joint.

29. The disinfection device assembly of claim 1, wherein the outer geometry of the central plug includes a frustoconical tapered surface that is effective in complementing the inner surface of the lumen of the male medical connector.

30. The disinfection device assembly according to claim 1, wherein the proximal and distal housings comprise a polymer material selected from the group consisting of polyethylene, polypropylene, thermoplastic elastomer (TPE), or a combination thereof.

31. The disinfection device assembly according to claim 1, wherein the male medical connector includes a male Luer connector.

32. The disinfectant device assembly of claim 1, wherein the liquid disinfectant or antibacterial agent is selected from the group essentially consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

33. The disinfection device assembly of claim 32, wherein the liquid disinfectant or antibacterial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

34. The disinfection device assembly according to claim 1, wherein the central post is integrally formed with the proximal wall of the integrated body.

35. The disinfectant device assembly of claim 23 wherein the liquid disinfectant or antibacterial agent adheres between the plurality of slits and the plurality of prongs.

36. A method for disinfecting medical connectors, The MLDU of claim 1 is positioned in the male medical connector by bringing the distal tip of the medical connector and the thread into contact with the scrub foam and the foam cover, wherein the central plug prevents the disinfectant from entering the lumen of the male medical connector. Methods that include...

37. A medical assembly comprising the MLDU according to claim 1, which is connected to a medical connector having a male Luer connector.

38. A method for manufacturing a disinfection device assembly, A step of connecting an NCDU and an ML disinfection unit to a syringe assembly, wherein the NCDU engages with a threaded locking luer-type collar of the syringe assembly, and the MLDU engages with a stopper including a thumb press. Methods that include...

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