Flush syringe with integrated male and female luer scrubbing devices

Abstract

An integrated disinfecting device assembly is described syringe assembly having two integrated disinfection units assembled to a syringe for disinfecting and sterilizing corresponding medical connectors, specifically access ports of corresponding medical connectors. The integrated disinfection units include a Needleless Connector Disinfecting Unit (NCDU) and a Male Luer Disinfecting Unit (MLDU) disposed on a syringe assembly. The NCDU having a first chamber containing a first absorbent material, a first disinfectant or an antimicrobial agent in the first housing, and a first peelable seal. The MLDU for a male medical connector comprising a housing, a scrubbing foam having a plurality of slits disposed within a first cavity of the housing, a central post extending from the closed bottom of the housing and positioned within the first cavity of the housing, a scrubbing foam disposed around within the inner surface of the integral body, a foam jacket disposed on the central post and having a plurality of slits, a central plug disposed in the center of the central post extending from the top wall of the central post and extending into the second cavity of the foam jacket, a second disinfectant or an antimicrobial agent in the, and a second peelable seal. The inner surface of the foam jacket defines a second cavity. A threaded connection is disposed on the bottom exterior surface of the first scrubbing device having threads that are sized and pitched to engage threads of a luer lock collar on the distal end of the syringe barrel to allow the proximal housing to be connected to the syringe assembly. The MLDU and the syringe assembly are integrally connected at the thumb press of the syringe and ledge of the MLDU. In one or more embodiments, the MLDU and the syringe assembly are interlocked through interference fit or snap fit of the thumb press of the syringe and ledge of the MLDU.

Description

P-28177.WO01 PATENT FLUSH SYRINGE WITH INTEGRATED MALE AND FEMALE LUER SCRUBBING DEVICES TECHNICAL FIELD ^

[0001] The present disclosure generally relates to an integrated disinfecting device assembly having both a Needleless Connector Disinfecting Unit (NCDU) including a scrubbing device to scrub and disinfect a Needleless connector (NC) or a female Luer connector and a Male Luer Disinfecting Unit (MLDU) including a scrubbing device to scrub and disinfect^^^male Luer connector. The NCDU comprises a proximal housing, a distal^ housing, a first closed proximal end, 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, 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 a NCDU and MLDU assembled to a syringe for disinfecting and sterilizing both corresponding female and male medical connectors, specifically access ports of corresponding medical connectors. ^ BACKGROUND

[0002] Vascular access devices (VADs) are commonly used therapeutic devices, which include intravenous (IV) catheters and needleless access devices. The operation of VADs is often compromised or completely prevented by the occurrence of thrombus formation. Thrombosis is the development of a blood clot within a vessel and / or vascular access device. If^ not properly maintained or if exposed to a non-sterile environment, the VADs can become contaminated, sealed with blood clots or spread infection. Bacteria and other microorganisms may enter a patient’s vascular system from access hub, port, or valve upon connection to the VAD to deliver the fluid or pharmaceutical. Each access hub, port, valve or connection is associated with some risk of transmitting a catheter related bloodstream infection (CRBSI),^ which can be costly and potentially lethal. In order to decrease CRBSI cases and to ensure VAD's are used and maintained correctly, standards of practice have been developed, which ^P-28177.WO01 PATENT include disinfecting and cleaning procedures. To ensure VADs are used properly and do not become sealed or infected, protocols to ensure sterile practice have been developed. These protocols include sterilizing the VAD and flushing the catheter with a flush solution. Catheters are flushed using syringe assemblies filled with various fluids. In some cases, different fluids^ comprising a lock solution are injected sequentially in accordance with the protocol. For example, a lock solution may be 4% Sodium Citrate or a saline solution followed by an anticoagulant such as heparin. VAD protocols usually recommend flush procedures be performed after catheter placement, before fluid infusion, and before and after drug administration, blood sampling, transfusions and parenteral nutrition. The goal of these flush^ procedures is to confirm catheter patency, avoid drug incompatibilities, ensure the complete drug dose administration, prevent thrombus formation and minimize the risk of blood stream infections.

[0003] In developed markets, when utilizing an IV catheter, a needleless connector will typically be used to close off the system and then subsequently accessed to administer^ medication or other necessary fluids via the catheter to the patient. Infusion Nurses Society (“INS”) Standards of Practice recommend the use of a needleless connector and state that it should be "consistently and thoroughly disinfected using alcohol, tincture of iodine or chlorhexidine gluconate / alcohol combination prior to each access." The disinfection of the needleless connector is ultimately intended to aid in the reduction of bacteria that could be^ living on the surface and possibly lead to a variety of catheter related complications including CRBSI. Nurses will typically utilize a 70% isopropyl alcohol (IPA) pad to complete this disinfection task by doing what is known as "scrubbing the hub." However, compliance to this practice is typically very low. In addition to a lack of compliance to "scrubbing the hub", it has also been noted through clinician interviews that there is often a variation in scrub time, dry^ time and the number of times the needleless connector is scrubbed.

[0004] Throughout the sequence of procedures associated with the transmission of a microorganism that can cause a CRBSI, there are many risks of contact or contamination. By way of example, contamination can occur during drug mixing, attachment of a cannula, and insertion into the access hub. Furthermore, threaded connectors have an open luer with an^ exposed lumen. Because the procedure to connect to a VAD is so common and simple, the risk associated with entry into a patient’s vascular system has often been overlooked. Presently, the ^P-28177.WO01 PATENT risk to hospitals and patients is a substantial function of the diligence of the clinician performing the connection, and this diligence is largely uncontrollable.

[0005] VAD standards and practices commonly include disinfecting both the threaded male connector and the IV catheter connection. The additional disinfection steps decrease the^ likelihood of contamination while also increasing the likelihood of non-compliance with disinfection procedures.

[0006] Current “recommended practice” for aseptic IV line maintenance and IV drug delivery practices require adherence to a stepwise process referred to as “SASH.” During the first step of the process, the clinician cleans / disinfects (generally with an alcohol swab) the^ VAD connector. Second, a syringe containing saline is used to flush the IV line or catheter (Saline flush), and then the VAD connector is disinfected a second time. Third, the fluid or pharmaceutical therapy is administered through the IV line or catheter (Administer therapy), the VAD connector is disinfected a third time, followed by a second Saline flush step. The final step, which is dependent upon the patient’s need and institutional policy, is a 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 the formation of thrombi or blood clots. A separate disinfecting cap may be used to sterilize the hub of the VAD. This “recommended practice” requires disinfecting the VAD connector after each access makes IV line maintenance a very burdensome and time ^ consuming process. Because the process is so cumbersome, clinicians are less likely to implement this “recommended practice” in its entirety, and, thus, patients are exposed to the risk of contracting CRBSIs. Microorganisms populate exposed connector inlet surfaces, and, when the “recommended practice” is not adhered to, the microorganisms can enter the IV line during flushing. Furthermore, blood reflux into the IV line or catheter can cause clot formation^ inside the lines, and microorganisms from the connector inlet surfaces can colonize blood clots inside the lines and infect the patients during flushing.

[0007] Current practice requires users to obtain a separate disinfection unit product to ensure the VAD connector cleanliness after, e.g. saline flush and before the next procedure, e.g. medication injection. There is a need, therefore, for an integrated disinfection unit^ assembled to a syringe that promotes compliance with aseptic technique by eliminating the additional swabbing and disinfecting steps while reducing the number of separate flushing and disinfecting apparatuses used in current practice. 3 ^P-28177.WO01 PATENT

[0008] Currently, the workflow to sanitize hub is performed with only one single device, which is typically an IPA pad or similar IPA scrubbing device. After the sanitation is performed, the line is flushed with the syringe. Next, the medication is administered to the patient. The hub sanitization prior to this administration can easily be missed as the IPA pad or^ scrubbing device is not readily available. Next, a second flush is performed to clear the line. An IPA pad or scrubbing device is used to clean the hub prior to use if it is integrated with the flush syringe. Lastly, the line is locked with a lock solution (example: 4% Sodium Citrate or heparin), but the hub is not sanitized prior to administration as the IPA pad or scrubbing device is not readily available. Currently products and practice does not address any cleaning after^ flushing as the sanitization ends after the flush. INS guidelines also recommend cleaning the connector before each access. Thus, current solutions on the market do not include additional scrubbing devices to enforce sanitization prior to medication or lock solution administration.

[0009] When an IV line with male luer is not connected to needleless connector for IV infusion, the male luer including its threads might not be protected and may be contaminated^ with bioburden, microbes, dirt, etc. Thus, when connection between needleless connector and male luer is needed to resume IV infusion, both the access points need to be scrubbed and disinfected.

[0010] Thus, there is a need to provide an integrated disinfecting device for scrubbing and disinfecting both a needleless connector having a female luer connector and a male luer^ connector that may be connected to an IV line. An integrated disinfecting device would increase the compliance for scrubbing both the male luer connector on an IV line and a female luer connection on a needlefree connector to sanitize the hub or connecting interfaces prior to medication or lock solution administration. ^ SUMMARY

[0011] One aspect of the present disclosure pertains to a disinfecting 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 Disinfecting Unit (NCDU), a syringe and a^Male Luer Disinfecting Unit (MLDU). ^

[0012] The Needleless Connector Disinfecting Unit (NCDU) comprises a proximal housing, a distal housing, a first closed proximal end, a first annular wall having a length ^P-28177.WO01 PATENT extending from the first closed proximal end to a first open distal end that defines a first chamber containing a first absorbent material, a first disinfectant or an antimicrobial agent, and a first peelable seal having a first top web.

[0013] The Male Luer Disinfecting Unit (MLDU) comprises an integral body, a second^ closed proximal end, an annular wall extending from the second closed proximal end to a second open distal end that defines a second chamber containing a second absorbent material, the second closed proximal end of the annular wall having a ledge extending from the closed end, a second disinfectant or an antimicrobial agent in the second chamber, and a second peelable seal having a top web. The outer scrubbing foam and foam jacket are soaked in the^ second disinfectant or the antimicrobial agent.

[0014] The first open distal end of the NCDU defines an engagement surface to contact the first peelable seal and the second open distal end of the MLDU defines a sealing surface to contact the surface of the second peelable seal.

[0015] A connection element is disposed on the bottom wall of the NCDU allowing it^ to be connected to a syringe. In one or more embodiments, the syringe assembly can be attached to the NCDU using various methods including, but not limited to, mechanical fasteners, snap-fittings, and threaded connection. In one or more embodiments, the connection element is a threaded connection and may include integrated threads or tabs. In a specific embodiment, the connection element is a luer threaded connection. In one or more ^ embodiments, a threaded connection is disposed on the bottom exterior surface of the NCDU of the disinfection unit having threads that are sized and pitched to engage threads of a luer lock collar on the distal end of the syringe barrel to allow 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 that ^ corresponds to the internal thread of the locking luer-type collar on the distal end of the syringe barrel.

[0016] In one or more embodiments, the Male Luer Disinfecting Unit (MLDU) and the syringe assembly are integrally connected with the thumb press of the syringe. In one or more embodiments, the Male Luer Disinfecting Unit (MLDU) and the syringe assembly are^ interlocked through interference fit or snap fit of the thumb press of the syringe and a ledge of the MLDU. A ledge or wedge can be arranged at the closed end of the annular wall of the ML Disinfecting Unit to provide for a snap fit connection to the thumb press of a syringe assembly. ^P-28177.WO01 PATENT The inner surface of the top wall of the integral body disposed at the second closed proximal end of the annular wall of the integral body may have a recess, ledge or wedge into which the thumb press may be inserted.

[0017] In one or more embodiments, the second closed proximal end of the second^ annular wall of the ML Disinfecting Unit includes a peripheral ledge extending radially inward in a perpendicular direction from the annular wall. The ML Disinfecting Unit is adapted to be snap fitted over the thumb press of the plunger rod, opposite of a luer tip. In one or more embodiments, the ML Disinfecting Unit may be connected to the thumb press with a rim disposed on the peripheral ledge and radially inward to create a lip or rim. ^

[0018] In one or more embodiments, an interior surface of the peripheral ledge in the interior annular wall surface of the ML Disinfecting Unit at the second closed proximal end includes at least two or more mating protrusions which allow the thumb press to mate together with the ML Disinfecting Unit via a snap fit connection.

[0019] The NCDU can achieve disinfection when used on needle-free connector^ (“NFC”) by integrating a first disinfectant or antimicrobial agent in the first absorbent material disposed and housed in the first chamber of the NCDU. A male luer connector may achieve disinfection when contact is made with a second disinfectant or antimicrobial agent in the second absorbent material disposed and housed in the second chamber of the MLDU. The first and second disinfectant or antimicrobial agent can be directly included in the first chamber and^ second chamber and can be absorbed into first absorbent material (e.g. sponges or foam material) that fills the first chamber of the NCDU and second chamber of the MLDU respectively. The NCDU is designed to be compatible in interacting with various disinfectants. In one or more embodiments, the first disinfectant or antimicrobial agent or second disinfectant or antimicrobial agent may include variations of alcohol or chlorhexidine. In one or more^ embodiments, the first disinfectant or antimicrobial agent or second disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorohexidine, chlorhexidine diacetate, chlorohexidine gluconate, povidone^ iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotic, and mixtures thereof. In a specific embodiment, the first disinfectant or 6 ^P-28177.WO01 PATENT antimicrobial agent or second disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the first disinfectant or antimicrobial agent or second disinfectant or antimicrobial agent is a fluid or a gel. ^^

[0020] First absorbent material soaks up the first disinfectant or the antimicrobial agent that is housed within the first chamber of the NCDU. In one or more embodiments, the first absorbent material is a nonwoven material, foam, or a sponge. In a specific embodiment, the foam is a polyurethane foam. In a specific embodiment 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 a top web is disposed on the engagement surface of the distal housing to prevent the first absorbent material from exiting the first chamber. With the first absorbent material properly inserted into the first chamber of the NCDU, the first peelable seal may be secured to the engagement surface of the first open proximal end of the ^^^ NCDU to seal the NCDU.

[0022] A second absorbent material is disposed and housed in the second chamber of the ML Disinfecting Unit and soaks up the second disinfectant or the antimicrobial agent that is housed within the second chamber of the ML Disinfecting Unit. In one or more embodiments, the second absorbent material is a nonwoven material, foam, or a sponge. In a ^^^ specific embodiment, the foam is a polyurethane foam. In a specific embodiment 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 a top web is disposed on the engagement surface of the integral body to prevent the second absorbent material from exiting the second chamber. ^^^ With the second absorbent material properly inserted into the second chamber of the MLDU, the second peelable seal may be secured to the engagement surface of the second open distal end of the integral body to seal the MLDU.

[0024] The first peelable seal and second peelable seal can be chemically-resistant, light-blocking, non-permeable, or sterile. In one or more embodiments, the first peelable seal ^^^ and second peelable seal comprises an aluminum or multi-layer polymer film peel back top. In a specific embodiment, the first peelable seal and second peelable seal is heat-sealed or induction sealed to the engagement surface of the open end of the NCDU and the ML ^P-28177.WO01 PATENT Disinfecting Unit to seal them. In one or more embodiments, the first peelable seal and second peelable seal comprise a moisture barrier.

[0025] The proximal and distal housing and the integral body are made from any type 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 proximal and distal housing and the integral body comprise a polypropylene or polyethylene material.

[0026] Another aspect of the present disclosure pertains to an assembly comprising the NCDU of the disinfection device assembly of one or more embodiments connected to a syringe^ assembly. The syringe assembly includes a syringe barrel having an elongate body defining a chamber, an open proximal end having a flange and a distal end having a tip having a passageway therethrough in 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 an internal thread. Syringe assembly further includes a stopper connected^ to an elongate plunger rod having a thumb press at its proximal end. In one or more embodiments, the assembly may further include a medical connector is selected from a male luer connector, a female luer connector, and needleless connector.

[0027] Another aspect of the present disclosure pertains to a method of disinfecting a medical connector, the method comprising: connecting a disinfection device assembly of an^ embodiment of the present disclosure to a medical connector, wherein connecting includes removing the NCDU from the syringe assembly, peeling the top web of the first peelable seal from the NCDU; inserting the needle-free connector (“NFC”) into the first chamber of the NCDU and contacting the NFC with the first absorbent material soaked with disinfectant or the antimicrobial agent; this is followed by removing the NCDU from the syringe barrel by^ applying a torque on the entire assembly thus unthreading NCDU from the locking luer-type collar at the distal end of barrel; attaching the flush syringe to an IV catheter line by engages 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 line; unthreading the flush syringe from the NFC and peeling the top web from the ML Disinfecting Unit to expose the second absorbent material^ soaked in the second disinfectant, inserting the NFC into the chamber of the NCDU and contacting the NFC with the first absorbent material soaked with the first disinfectant or the antimicrobial agent. ^P-28177.WO01 PATENT

[0028] Another aspect of the present disclosure pertains to a method of manufacturing a disinfecting device assembly, the method comprising: connecting a needle-free connector (“NFC”) NCDU to a syringe, wherein the syringe engages the NCDU through a locking luer- type collar and the ML Disinfecting Unit engages the thumb press. The syringe is connected^ with the NCDU by engaging a threaded tip cap with a locking luer-type collar comprising an internal threading. The syringe is connected with the ML Disinfecting Unit by connecting the syringe assembly comprising an elongate plunger rod further including a thumb press to the ML Disinfecting Unit.

[0029] This summary is provided to introduce a selection of concepts in a simplified^ form that are further described below in the Detailed Description. This Summary 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 disclosure will be set forth in the description which follows, and in part will be obvious from the description, or may be learned^ by the practice of the disclosure. The features and advantages of the 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 disclosure as set forth hereinafter. ^ BRIEF DESCRIPTION OF THE DRAWINGS

[0031] FIG.1 illustrates a perspective view of a disinfecting device assembly according to an exemplary embodiment of the disclosure;

[0032] FIG. 2 illustrates an exploded perspective view of a Needleless Connector^ Disinfecting Unit (NCDU) according to an exemplary embodiment of the disclosure;

[0033] FIG. 3 illustrates a cross-sectional view of a NCDU according to an exemplary embodiment of the disclosure;

[0034] FIG.4 illustrates an exploded view of an alternate embodiment of a NCDU according to an exemplary embodiment of the disclosure; ^P-28177.WO01 PATENT

[0035] FIG.5 illustrates an exploded cross-sectional view of fig.4 according to an exemplary embodiment of the disclosure;

[0036] FIG. 6 illustrates a flow chart of a disinfection process of a needle free connector using a NCDU in accordance with an exemplary embodiment of the disclosure; ^^

[0037] FIG. 7 illustrates an exploded perspective view of a Male Luer Disinfecting Unit (MLDU) according to an exemplary embodiment of the disclosure;

[0038] FIG. 8 illustrates a cross-sectional view of a MLDU according to an exemplary embodiment of the disclosure;

[0039] FIG.9 illustrates a perspective view of the MLDU with a removable cap in ^^^ accordance with an exemplary embodiment of the disclosure;

[0040] FIG. 10 illustrates perspective view of the male connector of the prior art and a MLDU in accordance with an exemplary embodiment of the disclosure;

[0041] FIG. 11 illustrates a flow chart of perspective cross-section views of a disinfection process of a male luer medical connector of prior art according to an exemplary ^^^ embodiment of the disclosure;

[0042] FIG. 12 illustrates perspective side views of a disinfecting device assembly 100 with an attached ML Disinfecting unit 150 according to a first exemplary embodiment of the disclosure;

[0043] FIG. 13 illustrates perspective side views of a disinfecting device assembly 100 ^^^ with a fitted ML Disinfecting unit 150 according to a second exemplary embodiment of the disclosure;

[0044] FIG. 14 illustrates perspective side views of a disinfecting device assembly 100 with a screw-on ML Disinfecting unit 150 according to a third exemplary embodiment of the disclosure; and ^^^

[0045] FIG. 15 illustrates perspective side views of a disinfecting device assembly 100 with a snap fitted ML Disinfecting unit 150 according to a fourth exemplary embodiment of the disclosure. ^P-28177.WO01 PATENT DETAILED DESCRIPTION

[0046] In the current practice of SASH (Saline-Administration-Saline-Heparin) workflow, a clinician removes the disinfecting cap attached to the dwelling catheter hub to be flushed and proceeds to scrub the hub using a disinfecting wipe or scrubbing device. Next, the^ clinicianflushes the intravenous (IV) line using a Flush syringe to make sure the catheter is working before infusing. After the first flush, the clinician then scrubs the hub using a disinfecting wipe or scrubbing device and ^dministers a drug in the IV line. After drug administration, the clinician again scrubs the hub using a disinfecting wipe or scrubbing device. The clinician then performs a second flush of the IV line using a Flush syringe to^ remove any medication left in your catheter and scrubs the hub using a disinfecting wipe or scrubbing device. The clinician then “locks” the IV line using a lock syringe filled with a 4% Sodium Citrate or heparin flush to help prevent blood clots from forming in the catheter. Finally, a new disinfecting cap is attached to the dwelling catheter hub. Thus, current practice requires 4 scrubbing devices, 2 flush syringes, 1 disinfecting cap and 1 lock syringe. ^

[0047] Before describing several exemplary embodiments of the present disclosure, it is to be understood that the disclosure is not limited to the details of construction or process steps set forth in the following description. The disclosure is capable of other embodiments and of being practiced or being carried out in various ways.

[0048] Embodiments of the present disclosure pertain to a disinfecting device assembly^ for connection to a medical connector including a syringe assembly with two integrated disinfection units assembled to the syringe assembly for connection to and disinfection of corresponding medical connectors, including threaded connectors. In one or more embodiments, the connectors are male luer connectors or female luer connectors. The disclosure aims to provide a mechanism capable of disinfecting both the lumen of open luers^ and the corresponding IV connector while minimizing additional steps in medical administration. It is contemplated that the disinfection unit disclosed herein can be utilized with male or female threaded connectors. The disclosure aims to provide a mechanism to disinfect an IV needleless connector during syringe use, therefore saving the clinician time and reducing work steps. The disclosure aims to reduce the number of steps required in preventing^ contamination of a vascular access device (VAD). ^P-28177.WO01 PATENT

[0049] Embodiments of the present disclosure also pertain to a sterile male connector Disinfecting Unit connection to and disinfection of a medical connector, specifically male connectors. The male connectors can be male Luer connectors. Embodiments of the disclosure pertain to male luer disinfection device which disinfect the threaded surfaces and the^ exterior surfaces of male luer connectors by a combination of scrubbing and chemical action due to the disinfectant in the cap. Specific embodiments of the present disclosure relate to a NCDU containing a liquid disinfectant for use with male connectors capable of providing both passive disinfection by use of a liquid disinfectant and active disinfection by use of a scrubbing motion. The MLDU of the integrated disinfecting device assembly of the present disclosure^ also prevents ingress of the liquid disinfectant into the lumen of the male luer connector.

[0050] With respect to terms used in this disclosure, the following definitions are provided.

[0051] As used herein, the use of “a,” “an,” and “the” includes the singular and plural.

[0052] As used herein, the term “catheter related bloodstream infection” or “CRBSI”^ refers to any infection resulting from the presence of a catheter or IV line.

[0053] As used herein, the term “Luer connector” refers to a connection collar that is the standard way of attaching syringes, catheters, hubbed needles, IV tubes, etc. to each other. The Luer connector consists of male and female interlocking tubes, slightly tapered to hold together with a simple pressure / twist fit. Luer connectors can optionally include an additional^ outer rim of threading, allowing them to be more secure. The Luer connector male end is generally associated with a flush syringe and can interlock and connect to the female end located on the vascular access device (VAD). A Luer connector comprises a distal end, a proximal end, an irregularly shaped outer wall, a profiled center passageway for fluid communication from the chamber of the barrel of a syringe to the hub of a VAD. A Luer^ connector also has a distal end channel that releasably attaches the Luer connector to the hub of a VAD, and a proximal end channel that releasably attaches the Luer connector to the barrel of a syringe.

[0054] As used herein, the term “syringe” refers to a simple pump-like device consisting of a plunger rod that fits tightly in a barrel or tube. The plunger rod can be pulled or^ advanced along inside the barrel, allowing the syringe to take in and expel a 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. ^P-28177.WO01 PATENT

[0055] Reference to “pre-filled syringe assembly” includes syringes which have barrels filled prior to delivery to the user with a solution or medicament during or after the assembly of the syringe using sterile filling methods. Pre-filled syringe assembly include syringe assemblies are indicated for use in the flushing of vascular access devices (VADs). ^

[0056] As used herein, the term “medical device” refers to common medical devices having threaded or interlocking connections, the connections having corresponding mating elements. By way of example but not limitation, a syringe has a male threaded connection which releasably interlocks with a secondary medical device such as a female luer connection of a catheter, an IV line and the like. The threaded connection includes a lumen defining a fluid^ path surrounded by a protruding wall having the threaded means for attaching to the secondary medical device.

[0057] As used herein, the term “disinfectant” includes antimicrobial agents.

[0058] As would be readily appreciated by skilled artisans in the relevant art, while descriptive terms such as “thread”, “tab”, “wall”, “top”, “side”, “bottom” and others are used^ throughout this specification to facilitate understanding, it is not intended to limit any components that can be used in combinations or individually to implement various aspects of the embodiments of the present disclosure.

[0059] The matters exemplified in this description are provided to assist in a comprehensive understanding of exemplary embodiments of the disclosure. Accordingly,^ those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the disclosure. Also, descriptions of well-known functions and constructions are omitted for clarity and conciseness. Before describing several exemplary embodiments of the disclosure, it is to be understood that the disclosure is not limited to the details of construction or process^ steps set forth in the following description. The disclosure is capable of other embodiments and of being practiced or being carried out in various ways.

[0060] Clinicians need to handle multiple components while accessing an intravenous (IV) line or catheter as they are required to open and disinfect the hub, open the syringe, hold the line in place, etc. while ensuring that none of the devices touch any surfaces as this would^ lead to contamination and blood stream infections which can have deadly outcomes. Therefore, accessing an intravenous (IV) line or catheter is not straightforward and requires a ^P-28177.WO01 PATENT certain level of dexterity to carry out the procedure while preventing the syringe tip from coming into contact with the surrounding environment. If the syringe tip touches any non- sterile surfaces, “touch” contamination can occur which can cause microbial growth in the IV line and consequently lead to incidents of catheter-associated-bloodstream infection ^ (“CRBSI”) and central line–associated bloodstream infection (“CLABSI”) which are very costly and lethal.

[0061] Embodiments of the present disclosure relate to a disinfection unit including a pre-filled syringe assembly having two integrated disinfection units assembled to the syringe. The disinfection units provide means of mechanical and chemical disinfection, i.e. a scrubbing^ unit (foam, etc.) and a chemical disinfectant (alcohol, etc.).

[0062] The flush syringe contains flush solution e.g. saline or other medication through the shelf life of the product and enables delivery of this saline during use, i.e. the syringe is connected to a hub (such as needle-free connectors, etc.) and the syringe contents are delivered. ^

[0063] The disinfection unit provides means of disinfection of the hub, through mechanical and chemical disinfection. The disinfection unit contains the chemical disinfectant (such as Isopropyl alcohol 70%) through the shelf life of the product.

[0064] As discussed below, embodiments of the present disclosure allow for non- permanently joining the disinfection units to the syringe unit for performing the disinfection^ and the following flushing process in standard SASH procedures. Embodiments of the present disclosure provide non-permanent mechanical means of joining the disinfection units to the syringe. Embodiments of the present disclosure engage the disinfection units and the syringe tip or thumb press on the assembly line, using threaded connection or flexible elements, e.g. clips, on the syringe or the disinfection unit. The threaded connection or flexible elements, e.g.^ clips, tabs, etc., may be disposed on either the disinfection unit or the syringe (engage to a corresponding mating feature on the other component, lock, and prevent disengagement once the disinfection unit and the syringe tip cap are assembled until desired use by a clinician).

[0065] Referring now to the drawings, wherein like reference numerals designate identical or corresponding parts throughout the several views, embodiments of the present^ disclosure are described as follows.

[0066] In one or more embodiments, an assembly comprises the device of one or more embodiments connected to a medical connector. In one or more embodiments, the medical ^P-28177.WO01 PATENT connector is selected from a male luer connector, a female luer connector, and needleless connector.

[0067] Referring to Figs.1-15, the disinfecting device assembly 100 capable of connection 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 Disinfecting Unit (NCDU) 130 and a Male Luer Disinfecting Unit (MLDU) 150. As shown in Fig.1, syringe assembly 110 having a syringe barrel 111 having an elongate body 112 defining a chamber 115 for retaining 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 passageway 122^ therethrough in fluid communication with the chamber. As shown in Fig.2, The distal end 114 of the barrel also includes a locking luer-type collar 120 concentrically surrounding tip 121. The locking luer-type collar 120 has internal threading 123. The syringe assembly 110 further includes a stopper 116 connected to an elongate plunger rod 117 having a thumb press 118 at its open proximal end 113, integrally connected to a MLDU 150. The disinfecting device^ assembly 100 further includes a NCDU 130 at its distal end 114, connected to the locking luer- type collar 120.

[0068] Referring to Figs.2-5, the NCDU 130 comprises a proximal housing 134 and a distal housing 135, a first closed proximal end 132, a first annular wall 136 and a second annular wall 137 having a combined length extending from the first closed proximal end 132 to^ a first open distal end 133 that defines a first chamber 141 containing a first scrubbing foam 139, a first disinfectant 145 in the NCDU 130, and a first peelable seal 131 having a first top web 143. The first scrubbing foam is soaked in the first disinfectant 145. The first open distal end 133 defines an engagement surface to the first peelable seal 131. The proximal housing 134 having a plurality of vertical receiving grooves 198 disposed around the inner surface of^ the first annular wall 136 and a circumferential rib 202 disposed around the inner surface of the first annular wall 136. The distal housing 135 having a plurality of vertical alignment ribs 197 disposed 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 disposed around the outer surface of the second annular wall 137 configured to receive the circumferential rib 202.^

[0069] As shown in Fig.1, the syringe assembly 110 can be attached to the proximal housing 134 of the NCDU 130 by mechanical mating features. Once assembled together, the syringe assembly 110 and proximal housing 134 of NCDU 130 can withstand axial and radial ^P-28177.WO01 PATENT disassembly forces. To remove the proximal housing 134 of NCDU 130 from the syringe assembly 110, the user shall apply a torque on the entire assembly thus unthreading the NCDU 130 from the locking luer-type collar 120 at the distal end 114 of the syringe barrel 111 to allow attachment of the flush syringe to the IV catheter line. When a torque is applied to either^ the syringe barrel 111 or the proximal housing 134 of NCDU 130 or both, the NCDU 130 should unthread off from the syringe assembly 110.

[0070] FIG. 6 illustrates a flow chart of a disinfection process of a needle free connector using a NCDU in accordance with an exemplary embodiment of the disclosure;

[0071] Referring to Figs.7-8, the ML Disinfecting unit 150 comprises an integral body^ 153, a second closed proximal end 151, 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 a second chamber 168.

[0072] As shown in Figs.7-8, the ML Disinfecting unit 150 and the syringe assembly 110 are integrally attached or interlocked through interface fit, snap fit or screw fit of the^ thumb press 118 of the syringe assembly 110 and a proximal wall 170 of the ML Disinfecting Unit 150. Interlocking portions of the ML Disinfecting unit 150 can be arranged at the second closed proximal end 151 of a second annular wall 167 of the ML Disinfecting unit 150 to provide for a snap on connection to the thumb press 118.

[0073] Fig.7 is an exploded view of a ML Disinfecting unit 150 according to one or^ more embodiments of the present disclosure. Fig.8 illustrates a cross-sectional perspective side view of the ML Disinfecting Unit 150. As shown in Figs.7-8, ML Disinfecting unit 150 comprises an integral body 153, a central post 173, a foam jacket 155, a central plug 154, an outer scrubbing foam 156 and first disinfectant 145.

[0074] FIG.7 illustrates an exploded perspective view of a Male Luer Disinfecting^ Unit (MLDU) according to an exemplary embodiment of the disclosure and FIG.8 illustrates a cross-sectional view of a MLDU according to an exemplary embodiment of the disclosure. The MLDU 150 which includes an integral body 153 having a second closed proximal end 151 comprising a proximal wall 170, a second open distal end 152 defining the opening 171 to receive a hub of a male luer connector, 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 integral 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 ^P-28177.WO01 PATENT open distal end 152, and the second annular wall 167 define a second chamber 168 of the integral body 153 configured to receive a 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. The^ opening 171 is disposed at the second open distal end 152 of the integral body 153 to receive the hub of a male luer connector.

[0075] The integral body 153 can be made from a number of 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 integral body 153 comprises a polypropylene or polyethylene material.

[0076] The ML Disinfecting unit 150 includes a central post 173 extending from the center of the second closed proximal end 151 of the integral body 153 and positioned within the second chamber 168. In one or more embodiments, central post 173 is molded into the^ integral body 153 as a single molded plastic.

[0077] In one or more embodiments, as shown in Fig.8, the central post 173 is integrated or built into the bottom wall of the second chamber 168 of the integral body 153. The central post 173 is positioned within the second chamber 168 of the integral body 153 and can be essentially cylindrical and coaxial with the second annular wall 167. An inner surface of^ the proximal wall 170 can form a top of the second chamber 168. In an embodiment, the central post 173 is integrally formed with the integral body 153. Central post 173 is integrally formed with the proximal wall 170 of the integral body 153. In one or more embodiments, central post 173 is molded into the integral body 153 as a single molded plastic.

[0078] In one or more embodiments, central plug 154 is joined to the central post 173^ by a ball and socket joint. The central plug 154 is free to rotate about its axis due to a ball and socket joint at the root.

[0079] In an alternate embodiment (not shown), the central post is attached to the proximal wall 170 of the integral body 153 by, for example, a snap-fit attachment.

[0080] A second cavity 162 of the integral body 153 is defined by an inner surface 174^ of the foam jacket 155 that is disposed on 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 a mating feature of a male Needleless connector. Such 17 ^P-28177.WO01 PATENT connectors are generally and commonly used as catheters and other fluid-tight protective connectors in medical applications. In one or more embodiments, the central post 173 can extend essentially from an inner surface of the proximal wall 170 toward the second open distal end 152 of the integral body 153. ^

[0081] In one or more embodiments, the central post 173 can extend essentially parallel to the second annular wall 167 of the integral body 153. The central post 173 can be made of plastic, or a thermoplastic elastomer (TPE), or a blend of plastic (such as polypropylene (PP) or polyethylene (PE)) with TPE material. The central post 173 can be made from any of a number of 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 a polypropylene or polyethylene material.

[0082] A foam jacket 155 extending from the central post 173 and the inner surface 174 of the foam jacket 155 defines a second cavity 162 disposed within the second chamber^ 168. The foam jacket 155 resides in a hollow defined by the outer scrubbing foam 156, which in turn resides in the cavity defined by the inner surface of the central post 173. The foam jacket 155 has an inner surface and outer surface to engage the medical connector. In one or more embodiments, the foam jacket 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 a sponge.^ In a specific embodiment, the foam is a polyurethane foam. In one or more embodiments, the top portion of the foam jacket 155 that extends beyond the top surface of the scrubbing foam includes one or more inner prongs 165 separated by one or more respective inner slits 166 that correspond to and are complementary to a one or more prongs 125 separated by one or more respective slits 126 in the top portion of the central post 173. Upon assembly, the foam jacket^ 155, which has similar precut projections formed by inner prongs 165 and inner slits 166 as in the central post 173, can be disposed over the central post 173.

[0083] A central plug 154 disposed in the center of the central post 173 extending from a top wall of the central post 173 and extending into the second cavity 162 of the foam jacket 155. The central post extends from an interior surface to the bottom wall of the housing; and^ can be integrally-formed with the housing. The MLDUs disclosed herein are advantageous because the inclusion of a central plug minimizes ingress of disinfectant, such as isopropyl alcohol or chlorohexidine, into the central lumen of medical connectors. ^P-28177.WO01 PATENT

[0084] The external geometry of the central plug 154 is sufficiently complementary to the open lumen luer connectors for engaging male luer connectors. When the central plug 154 engages with an open lumen in luer connectors such as a catheter or stopcock, the complementary inner luer wall applies radial pressure on the insert to make an interference fit.^ The bottom surface of the central plug 154 can cover the open lumen of the luer tip on the connector, thereby mitigating disinfectant ingress.

[0085] The central plug 154 may be a solid material that is so soft to compress longitudinally so when the MLDU is attached to male luers such as Needleless connectors and IV tubing end, it may retract toward a top wall at a closed end of cap housing, but rigid enough^ radially so it can form enough interference with open luer such as catheters or stopcocks.

[0086] As per established toxicology limits, maximum allowable limit is 14.3 mg / kg / day of 70% isopropyl alcohol (IPA). A maximum ingress limit per disinfectant cap may be calculated by dividing the maximum allowable limit of 14.3 mg / kg / day of 70% IPA by the total number of disinfectant caps used per day. For example, assuming a maximum of 16 caps^ used per day and worst-case patient being a 1 kg pre-term neonate, the ingress limit would be 0.89 mg of 70% IPA per cap. The central plug 154 allows for minimum / low IPA ingress, or ideally to prevent IPA ingress, by sealing due to cylindrical lateral surface. The central plug 154 fits into the lumen of male luer and thus reduces / avoids IPA ingress into the IV line. Central plug 154 keeps the male luer’s central line plugged so that minimal IPA ingress takes^ place in the line. The ball and socket joint of the central plug allows the central plug 154 to rotate freely inside the male luer and hence provides minimum resistance in rotation. Central plug 154 blocks the IV line during disinfection so well that it blocks the IV line to minimize disinfectant going into the IV line. In one or more embodiment, the central post 173 is free to rotate about its axis due to a ball and^ socket joint at the root.

[0087] The outer scrubbing foam 156 is disposed within a second chamber 168. In one or more embodiments, upon assembly, the outer scrubbing foam 156 is in direct contact with an interior surface of the proximal wall 170. In one or more embodiments, the outer scrubbing foam 156 is assembled into the central post 173. ^

[0088] In one or more embodiments, the outer scrubbing foam 156 is made of a second absorbent material 148. In one or more embodiments, the second absorbent material 148 is a ^P-28177.WO01 PATENT nonwoven material, foam or a sponge. In a specific embodiment, the foam is a polyurethane foam.

[0089] Central post 173 extends from the second closed proximal end 151 of the integral body 153 and positioned within the second chamber 168 supports the foam jacket 155^ and provides internal rigidity to the foam jacket 155. In one or more embodiments, the top portion of the central post 173 that extends beyond the top surface of the scrubbing foam includes one or more outer prongs 163 separated by one or more respective outer slits 164. In one or more embodiments, at least one of the outer prongs 163 or outer slits 164 can be configured to bend to facilitate interference fit between the central post and the mating feature^ of a male Needleless connector. In one or more embodiments, central post 173 can extend essentially from an inner surface of the proximal wall 170 toward the second open distal end 152 of the integral body 153. In one or more embodiments, the central post 173 can extend essentially parallel to the second annular wall 167 of the integral body 153.

[0090] The central post 173 also centers the outer scrubbing foam 156 and supports the^ outer scrubbing foam 156 by providing a fixed location and also providing rigidity to the outer scrubbing foam 156 which is disposed in the second chamber 168 of the integral body 153 between the central post 173 and the second annular wall 167 of the integral body 153.

[0091] As shown in Fig.7 and Fig.8, in one or more embodiments, the outer scrubbing foam 156 comprises a cylindrical body 231, bottom end 233, an annular wall 232 having a^ length extending from the bottom end 233 to an open top portion 234 that defines a second chamber 168 containing a second disinfectant 146. The bottom end 233 of the outer scrubbing foam 156 defines an end face 235 and includes a peripheral ledge 236 extending radially inward from the annular wall 232 to make contact with the distal tip of a male luer connector 200, the peripheral ledge 236 has a central aperture 237 sized to wrap around the 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 scrubbing foam 156 includes a plurality of outer slits 164 forming outer prongs 163 in the outer scrubbing foam 156. In one or more embodiments, the plurality of outer slits 164 are pre-cut in the body of the outer scrubbing foam 156 for effective cleaning of contaminated surfaces. In one or more^ embodiments, the plurality of outer slits 164 of the outer scrubbing foam 156 are in the form of finger-like outer prongs 163 configured for scrubbing. In one or more embodiments, the finger- like prongs are configured as projections or bristles. The outer scrubbing foam 156 is pressed ^P-28177.WO01 PATENT into a first cavity 161 which can retain any disinfectant within it due to surface tension and wettability feature. The outer scrubbing foam 156 disinfects the outer wall surface of the male luer connector through scrubbing. Annular wall 232 has a slotted end formed by outer slits 164 and a non-slotted end. In one or more embodiments, the outer slits 164 extends less than^ about halfway along the annular wall 232. The outer slits 164 allow a Luer tip of a male Luer connector to be inserted in the hollow cylindrical cavity so the sponge side wall can interact with a side surface of the male Luer connector and release the second disinfectant 146 onto a Luer surface. The outer slits 164 may open up when the male Luer connector is inserted onto the MLDU 150 and the Luer opens up the slot by pushing both sides of the sponge away.^

[0092] The annular wall 232 of the outer scrubbing foam 156 comprises an exterior wall surface 232A and an interior wall surface 232B. The interior wall surface 232B defines an opening adjacent the bottom end. The inner surface of the top portion of the outer scrubbing foam 156, the outer surface of the foam jacket 155 and the top surface of the peripheral ledge 160 define a concentric cavity. The top portion 234 of the sidewall of the^ outer scrubbing foam 156 includes a plurality of outer slits 164 that exists radially around the top portion 234 of the outer scrubbing foam 156 and extend from the top of the peripheral ledge 236 to the open top portion 234, which define multiple outer prongs 163 around the open top portion 234 of the outer scrubbing foam 156. The faces 238 of the outer prongs 163 may be chamfered at the top edge of the outer scrubbing foam 156. The outer prongs 163 have^ bottom ends defined by where each outer slit 164 ends 156a near the peripheral ledge 160. The outer slits 164 provide gaps within which disinfectant can cling and the outer slits 164 also provide flexibility to each of the outer prongs 163, allowing the outer scrubbing foam 156 to slide along an outer surface of the male luer connector when a force along the central axis is applied along the foam jacket 155 and the inner surface of the outer scrubbing foam 156, such^ as when a male luer connector is inserted into the ML Disinfecting Unit 150.

[0093] In one or more embodiments the foam jacket 155 includes a plurality of inner slits 166 in the foam jacket 155. In one or more embodiments, the plurality of inner slits 166 are pre-cut in the body of the foam jacket 155 for effective cleaning of contaminated surfaces. In one or more embodiments, the plurality of inner slits 166 of the foam jacket 155 are in the^ form of finger-like inner prongs 165 or projections configured for scrubbing. Disinfection of threaded region of a male luer is achieved when the foam jacket 155 wetted with the second disinfectant 146 contacts the sides wall of luer portion and internal threads in a male luer which 21 ^P-28177.WO01 PATENT scrubs and cleans these regions. Passive disinfection is achieved using alcohol-impregnated catheter hub protection caps. The MLDU 150 contain a sponge impregnated with alcohol that can be attached to the male medical connector, thus protecting the access point from contamination as well as providing disinfection. Active disinfection is performed using a wipe^ to mechanically loosen the microorganisms allowing the disinfectant to destroy the microorganisms. This procedure is often referred to as ‘scrubbing the hub’. The finger-like inner prongs 165 or projections in the foam jacket 155 are used for scrubbing and disinfecting the contaminated surfaces of the male luer connector. Foam jacket 155 scrubs the incoming male Luer’s front tip face, outer surface of Luer and the male luer threaded. Central plug 154 is^ joined to the central post 173 by a ball and socket joint. The central plug 154 is free to rotate about its axis due to Ball and Socket joint at the root. Central post 173 supports the foam jacket 155 and provides internal rigidity. The central post 173 which is lined with foam jacket 155 which has multiple bristle like structures enter in the region between outer surface of male luer taper and threaded region of the male luer connector. By clockwise and counter-clockwise^ rotation, these multiple bristle like structures actively remove the contaminants by loosening them with mechanical scrubbing action and further disinfect and kill the microbes by chemical disinfection due to disinfectant present in the cap (IPA).

[0094] When clockwise and counter-clockwise rotation is being realized, the central plug 154 remains tightly fitted to the inner lumen and rotates along with the male connector^ due to a ball and socket joint between the central plug 154 and central post 173. This does not allow relative motion between the central plug 154 and male connector thus avoiding IPA ingress into the IV line.

[0095] Foam jacket 155 which has similar precut inner prongs 165 and inner slits 166 that correspond to prongs 125 and slits 126 in the central post 173, allows the foam jacket 155^ to be disposed onto the central post 173. Thus central post 173 provides rigidity to the foam Jacket 155. The central post 173 has a socket joint like feature into which a central plug 154 is fitted (with defined tolerances) so that it remains in a fitted or fixed position until it plugs the lumen of an incoming male luer connector. The foam jacket 155 scrubs and disinfects the proximal tip, side wall and internal threaded region of a male luer connector. ^

[0096] In one or more embodiment, the foam jacket 155 comprises an integral cylindrical body, bottom end, top portion, an annular wall having a length extending from the bottom end to an open proximal end that defines a second cavity containing a second ^P-28177.WO01 PATENT disinfectant. The bottom end defines an end face and includes a peripheral ledge extending radially inward from the annular wall to make contact with the distal tip of the male luer connector, the peripheral ledge has a central aperture sized to house the central plug. The peripheral ledge defines an engagement surface for the distal tip of the male luer connector.^ The annular wall of the foam jacket 155 comprises an exterior wall surface and an interior wall surface. The inner surface of the top portion of the foam jacket 155 and the top surface of the peripheral ledge define a second cavity 162 containing the second disinfectant 146. The top portion of the sidewall of the foam jacket 155 includes a plurality of inner slits 166 that exists radially around the top portion of the foam jacket 155 and extend from the top of the peripheral^ ledge to the open end, which define multiple inner prongs 165 around top edge of the foam jacket 155. The faces of the inner prongs 165 may be chamfered at the top edge of the foam jacket 155. The inner prongs 165 have bottom ends defined by where each inner slit 166 ends near the peripheral ledge 160. The inner slits 166 provide gaps within which disinfectant can cling and the inner slits 166 also provide flexibility to each inner prong 165, allowing the foam^ jacket 155 to slide along threads and an outer surface of the male luer connector when a force along the central axis is applied along the foam jacket 155 and the inner surface of the outer scrubbing foam 156, such as when a male luer connector is inserted into the ML Disinfecting Unit 150. The annular wall spans between a slotted end formed by inner slits 166 and a non- slotted end. In one or more embodiments, the inner slits 166 extends less than about halfway^ along the annular wall. The inner slits 166 allow a Luer tip of a male Luer connector to be inserted in the hollow cylindrical cavity so the sponge side wall can interact with a threads and side surface of the male Luer connector and release disinfectant onto a Luer surface. The inner slits 166 may open up when the male Luer connector is inserted into the MLDU and the Luer opens up the slot by pushing both sides of the sponge away. ^

[0097] The central plug 154 resides in a hollow defined by the outer scrubbing foam 156, which in turn resides in the cavity defined by the inner surface of the central post 173.

[0098] In one or more embodiments, the external geometry of the outer scrubbing foam 156 and / or the foam jacket 155 may have a tapered edge with a range of angles that can be sufficiently complementary to a male Luer taper. ^

[0099] The second chamber 168 houses the outer scrubbing foam 156, central plug 154, central post 173, foam jacket 155 and the second disinfectant 146 within it. In one or more embodiments, the second disinfectant 146 is filled in the second chamber 168 to wet the outer ^P-28177.WO01 PATENT scrubbing foam 156 and the second cavity 162 to wet the foam jacket 155 to disinfect the threads and outer surface of a male luer connector. In one or more embodiments, the second disinfectant 146 is isopropyl alcohol (IPA).

[0100] Passive disinfection is achieved using disinfectant-impregnated outer scrubbing^ foam 156 and foam jacket 155 housed in the first cavity 161 of the ML Disinfecting unit 150 which contact NFC, thus protecting the access point from contamination as well as providing disinfection. Surface tension between the molecules of the second disinfectant 146 when interact with the pre-cut foam plurality of finger-like inner prongs 165 and outer prongs 163 in the body of the foam jacket 155 and outer scrubbing foam 156 both which holds IPA between^ pre-cut foam structure to keep the foam wetted and allow the liquid IPA to cling to foam projections’ structure on both the outer scrubbing foam 156 and foam jacket 155 due to surface tension. The disinfection is based on using foam jacket 155 which has similar outer prongs 165 that correspond to prongs 125 in the central post 173. The inner prongs 165 and outer prongs 163 allow the outer scrubbing foam 156 and foam jacket 155 to be assembled together.^ Due to surface tension between the foam jacket 155, the droplets of the second disinfectant 146 are held in the structure. A combination of mechanical and chemical disinfection is achieved^ when foam jacket 155 is inserted into the threaded portion of the male medical connector 200 and scrubbed allowing all the external surfaces of Male Luer to get disinfected. Recent studies have concluded that just chemical disinfection is insufficient to attained 4-log reduction of^ microbes. However, mechanical scrubbing that causes physical removal of contaminants in combination with chemical disinfection, e.g. with isopropyl alcohol (IPA), plays a key role in attaining 4-log reduction.

[0101] The interaction of the plurality of inner slits 166 and outer slits 164 resulting in the finger-like inner prongs 165 and outer prongs 163 with the surface tension properties of the^ second disinfectant 146 allows for a minimum volume of liquid disinfectant, such as IPA, to be used for scrubbing. Liquid IPA clings between the inner prongs 165 and outer prongs 163 due to the interaction of the foam projections and second disinfectant 146 clinging per the formula: W=2T wherein W: Weight of liquid IPA clinging and T: Surface tension on liquid IPA from foam projection. ^

[0102] The integrated disinfecting device assembly herein can achieve disinfection when used on male Luer connectors by passive disinfection when the male Luer connector is inserted into MLDU and makes contact with the second disinfectant 146 which is wetted in the ^P-28177.WO01 PATENT foam jacket 155 and the outer scrubbing foam 156 and an active disinfection when the male Luer connector is rotated back and forth (clockwise and counterclockwise) in a twisting motion while maintaining contact with the plurality of inner slits 166 of the foam jacket 155 and the outer slits 164 of the outer scrubbing foam 156. As shown in Figs.11-12, when the male^ medical connector 200 is inserted into the ML Disinfecting Unit 150, the second disinfectant 146 contacts the distal tip to provide an initial passive disinfection. Male medical connector 200 is inserted into ML Disinfecting unit 150 and the male medical connector 200 is rotated in a repeated clockwise and counterclockwise direction in a twisting motion to disinfect the outer surfaces and threads of the male luer via an active disinfection. The twisting action during^ attachment of the MLDU and sponge allows the finger-like projections of the^inner prongs 165 and outer prongs 163 to contact the internal threads and outer surface to the male luer with a scrubbing action which contributes towards physical removal of microorganisms (i.e., cleaning). Thus the twisting action increases disinfection activity when compared to use of 70% IPA alone. Thus, an advantage of using the integrated disinfecting device assembly of the^ present disclosure is that the MLDU of the present disclosure allows for disinfection of male luer connectors with both chemical disinfectant (passive disinfection) and scrubbing action (active disinfection). Thus, the combination of passive disinfection with active disinfection results in improved disinfection results. Once disinfection is completed, the ML Disinfecting unit 150 does not remain connected on the male connector and ML Disinfecting unit 150 can^ be discarded.

[0103] The integrated disinfecting device assembly, including both the NCDU and MLDU, are designed to be compatible in interacting with various disinfectants. In one or more embodiments, the first disinfectant 145 or second disinfectant 146 may include variations of alcohol or chlorhexidine. In one or more embodiments, the first disinfectant 145 or second^ disinfectant 146 is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorohexidine, chlorhexidine diacetate, chlorohexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal^ silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotic, and mixtures thereof. In a specific embodiment, the first disinfectant 145 or second disinfectant 146 ^P-28177.WO01 PATENT comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the first disinfectant 145 or second disinfectant 146 is a fluid or a gel.

[0104] In an exemplary implementation, a second peelable seal 157 can be provided to seal the opening 171 prior to use of ML Disinfecting Unit 150, for example, by attachment to^ sealing surface 172 of the second open distal end 152 of integral body 153. In one or more embodiments, the second peelable seal 157 comprises an aluminum or multi-layer polymer film peel back top including a peel tab 158. In a specific embodiment, 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 the second peelable seal 157 comprises a moisture barrier. According to^ exemplary embodiments of the disclosure, the ML Disinfecting unit 150 can receive a tip or hub of a needleless connector, for example after the peel seal sealing cavity is removed or when the second peelable seal 157 is pierced, within the second chamber 168. In one or more embodiments, a cap 159 is disposed over the second open distal end 152 of integral body 153.

[0105] FIG.4 illustrates the central plug 154 embedded in the central post 173. The^ central plug 154 comprises a substantially cylindrical body with a frustoconical top having a bottom wall, which spans the sidewall 224 of the central plug 154. In one or more embodiments, the bottom wall 223 of the central plug 154 comprises a tapered surface. In one or more embodiments, the central plug 154 attaches to an opening or channel in a center of the top wall of the central post 173. ^

[0106] A further aspect of the present disclosure pertains to a method of disinfecting a medical connector. The method comprises connecting the integrated disinfecting device assembly of one or more embodiments to a medical connector, wherein connecting includes contacting the female medical connector onto the inner or outer surface of the first cavity of the NCDU and a male connector to the second cavity of the MLDU upon insertion of the medical^ connector into the ML Disinfecting unit 150 such that the medical connector contacts the second absorbent material 148 and the second disinfectant 146.

[0107] As shown in Figs.8-10, in use, insertion of the male medical connector 200 into the first cavity 161 and second cavity 162 of the cap allows the connector to contact the second disinfectant 146 disposed within the outer scrubbing foam 156 and foam jacket 155 allowing^ disinfectant to be dispensed onto the threads and outer surfaces of the male luer connector^to disinfect. When a male medical luer connector is inserted inside the ML Disinfecting Unit 150, first the central plug 154 fits inside the inner lumen of luer blocking this entryway so that ^P-28177.WO01 PATENT the second disinfectant 146 from the cap does not percolate and ingress into the inner lumen of the male luer connector. Upon assembly of the ML Disinfecting unit 150 with a male medical connector 200, a lumen edge of the male luer connector compresses the foam jacket 155 and outer scrubbing foam 156 toward the proximal wall 170 at the second closed proximal end 151^ of the integral body 153, allowing the second disinfectant 146 to be dispensed onto the threads and outer surfaces of the male luer connector. When the central plug 154 engages with the open lumen, a complementary inner wall, e.g. Luer wall, applies radial pressure on the central plug 154 to make an interference fit with the inner wall of the male luer connector, which mitigates and / or prevents disinfectant ingress into the lumen. ^

[0108] Outer scrubbing foam 156 conforms the male IV connector's outer body and cleans the collar as well due to mechanical as well as chemical action.

[0109] The exemplary caps of the present disclosure are capable of continuous disinfection of a connector and minimize ingress of microbial agents.

[0110] Exemplary MLDUs 150 engage with male Luer connectors and upon mounting^ the cap onto a male Luer connector, the male Luer connector is inserted into the second cavity 162. The disinfectant of the disinfectant sponge contacts the male Luer connector after insertion of the connector into the second cavity 162 of the exemplary MLDU 150. After disinfecting the Male connector, ML Disinfecting unit 150 does not remain connected onto the male connector^and can be discarded. ^

[0111] A further aspect of the present disclosure pertains to an assembly. The assembly comprises the cap of one or more embodiments connected to a medical connector. In one or more embodiments, the medical connector is a male Luer connector or needleless connector.

[0112] A ledge / wedge portions can be arranged at the second closed proximal end 151^ of the second annular wall 167 of the integral body 153 to provide for a snap on connection to the thumb press 118. The inner surface of the top wall disposed at the second closed proximal end 151 of the second annular wall 167 of the integral body 153 may have a recess into which the ledge / wedge of the insert may be inserted.

[0113] In one or more embodiments shown in Figs.1-3, the mechanical mating and^ assembly features ensure that the device can be assembled in an automated process and ensure device integrity during transport, use, and over the course of the product's shelf life. The assembly of the NCDU 130 and locking luer-type collar 120 of the syringe assembly 110 of the 27 ^P-28177.WO01 PATENT present disclosure via a mechanical connection or threaded connection facilitates high speed, automated assembly.

[0114] Compared to separate flush syringe and disinfection unit products that are currently available, embodiments of the disinfecting device assembly 100 of the present^ disclosure provides easy access to multiple disinfection products at each flush and easier hand operation during disinfection followed by flushing.

[0115] In one or more embodiments, the disinfecting device assembly 100 includes a connection element allowing a syringe to be connected to a NCDU 130 and a ML Disinfecting Unit 150. In one or more embodiments, the connection elements include a threaded ^ connection, for example, luer threaded connection to allow the syringe assembly 110 to be connected to a NCDU 130. In an exemplary implementation of the embodiments of present disclosure, the disinfecting device assembly 100 includes integrated threads or tabs, and other features in any and all combinations allowing the proximal housing 134 to interface with 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 various methods including, but not limited to, mechanical fasteners, snap-fittings, and threaded connection. In one or more embodiments, a threaded connection is disposed on the bottom exterior surface of the proximal housing 134 of the disinfecting device assembly 100 having threads that are sized and pitched to engage threads of a locking luer-type collar 120 on the distal end 140 of the^ syringe barrel 111 to allow the assembled disinfecting device assembly 100 to be connected to a syringe. In one or more embodiments as shown in Figs, 2-3, the first annular wall 136 of the proximal housing 134 of the NCDU 130 includes a threaded post 138 disposed in the center of the first annular wall 136 of the proximal housing 134 that mates with a corresponding internal threading 123 of the locking luer-type collar 120 on the distal end 114 of the syringe barrel^ 111. As shown in Figs.10-13, there are multiple embodiments of the disinfecting device assembly 100 wherein the ML Disinfecting unit 150 and the syringe assembly 110 are connected through a multitude of fittings including interference fit, snap fit, screw fit and of the ML Disinfecting unit 150 onto the thumb press 118 of the syringe assembly 110.

[0116] In one or more embodiments, as shown in Figures 4 and 5, the plunger rod 117^ includes a MLDU 150 is attached to or built into the plunger rod to disinfect a male connector. These scrubbing devices disinfect connectors (male and / or female) and are then discarded after use. In an alternate embodiment, the ML Disinfecting unit 150 is adapted to be fitted onto the 28 ^P-28177.WO01 PATENT thumb press 118 of the elongate plunger rod 117, opposite of a tip 121. Referring to Fig.15, in one or more embodiments, the ML Disinfecting unit 150 may be connected to the thumb press 118 with a rim disposed on the peripheral ledge 160 and radially inward to create a lip or rim. An interior surface of the peripheral ledge 160 in the interior annular wall surface of the ML^ Disinfecting unit 150 at the second closed proximal end 151 includes at least two or more mating protrusions 192 which allow the thumb press to mate together with the ML Disinfecting unit 150 via a snap fit connection. In one or more embodiments, the snap fit connection comprises a protruding edge 187, clips 188, and a snap-in area 189. The protruding edge 187 may be disposed on an interior surface of the peripheral sidewall of the peripheral ledge 160 or^ the interior annular wall surface of the ML Disinfecting unit 150 at the second closed proximal end 151, and the corresponding snap-in area is disposed on the opposite surface as the protruding edge 187 to allow the protruding edge 187 and a snap-in area 189 to interlock.

[0117] In one or more embodiments, the clips 188 are configured as a locking mechanism whereby one-way flexing clips 188 which require relatively low axial forces to^ assemble and produce significant locking strength. As the ML Disinfecting unit 150 and the thumb press 118 are assembled, the clips 188 flex inward until they enter the thumb press 118 of the elongate plunger rod 117. Once contact between the clips 188 and thumb press 118 is made, the clips 188 spring or deflect outward creating a mate between the thumb press 118 and ML Disinfecting Unit 150. The clips 188 flex inward towards the integral body 153 of the^ MLDU150. Once the clips 188 move past and clear the thumb press 118, the clips 188 spring outward creating a permanent mate between the two parts without the use of adhesives.

[0118] As shown in Fig.12, in one or more alternate embodiments, the detachable male luer scrubbing device is attached to the thumb press of the plunger rod. As shown in Fig.12, mechanical locking is achieved by use of a protruding trapezoidal locking rib 182 and a^ corresponding receiving undercut 181. In one or more embodiments, the integrated ML Disinfecting unit 150 has a trapezoidal locking rib 182 protruding across the second closed proximal end 151 of the MLDU 150, corresponding to the receiving undercut 181 which is disposed across the face of the thumb press 118 on the present disclosure.

[0119] As shown in Fig.13, in one or more alternate embodiments, the detachable male^ luer scrubbing device is fitted inside a receiving cup integrally attached to the proximal end of the plunger rod. As shown in Fig.13, in one or more alternate embodiments, mechanical locking is achieved by use of an alignment rib 190 disposed along the outer edge of the integral ^P-28177.WO01 PATENT body 153 of the MLDU 150. In certain embodiments of the integrated MLDU 150 is press-fit into a corresponding receiving cup 183 integrally attached to the proximal end of the plunger rod. In one or more embodiments, a user may apply a 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 to receive alignment rib 190 and align the MLDU 150.

[0120] As shown in Fig.14, in one or more alternate embodiments, a detachable MLDU 150 may be screwed onto plunger rod. As shown in Fig.14, mechanical locking is achieved by use of a locking taper 184. In certain embodiments of the MLDU 150 with the^ thumb press 118 of the present disclosure, the MLDU 150 includes a locking taper which protrudes proximally outward from the second closed proximal end 151. The locking taper 184 includes a taper receiver 185 which when rotationally engaged with a grooved face 186 of the thumb press 118, secures the MLDU 150 to the thumb press 118.

[0121] As shown in Fig.15, a detachable MLDU 150may be snap fitted onto a plunger^ rod. As shown in Fig.15, the MLDU 150 and the syringe assembly are interlocked through interference fit or snap fit of the thumb press 118 of the plunger rod 117 and protruding edge 187 of the MLDU. A ledge / wedge portions can be arranged at the closed end of the annular wall of the MLDU to provide for a snap on connection to the thumb press 118. The inner surface of the top wall disposed at the closed end of the annular wall of the MLDU 150 may^ have a recess into which the rim of the thumb press may be inserted.

[0122] The closed end defines an end face that includes a protruding edge 187 extending radially outward from the annular wall.

[0123] The MLDU 150 is adapted to be snap fit over the thumb press 118 of the plunger rod 117. Referring to Fig.15, in one or more embodiments, the MLDU 150 may be^ connected to the thumb press 118 with a rim disposed on the peripheral ledge and radially inward to create a lip or rim. In one or more alternate embodiments, an interior surface of the peripheral ledge in the interior annular wall surface of the MLDU at the closed end includes at least two or more mating protrusions 192 which allow the thumb press to mate together 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 sidewall of the peripheral ledge or the annular wall surface of the MLDU at the ^P-28177.WO01 PATENT closed end, and the corresponding snap-in area is disposed on the opposite surface as the protruding edge to allow the protruding edge and snap-in area to interlock.

[0124] As the MLDU 150 and thumb press 118 are assembled, the second closed proximal end 151 of the MLDU 150 is oriented to face the top end of the thumb press 118.^ Specifically, during assembly of the MLDU 150 and the thumb press 118, the second closed proximal end 151 of the MLDU 150 is inserted into the thumb press 118. Once the assembly is complete, the mechanical mating prevents the MLDU 150 from being removed from the thumb press 118 by pulling the components away from each other.

[0125] The NCDU 130 can achieve disinfection when used on needle-free connector^ (“NFC”) by integrating a first disinfectant 145 in the first absorbent material 147 disposed and housed in the first chamber 141 of the proximal housing 134. The first disinfectants 145 can be directly included in the first chamber 141 and can be absorbed into the first absorbent material 147 that fills the chamber of proximal housing 134. The NCDU 130 is designed to be compatible in interacting with various disinfectants. In one or more embodiments, the first^ disinfectant 145 may include variations of alcohol or chlorhexidine. In one or more embodiments, the first disinfectant 145 is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl- hydroquinone, chloroxylenol, chlorohexidine, chlorhexidine diacetate, chlorohexidine^ gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotic, and mixtures thereof. In a specific embodiment, 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. ^

[0126] First absorbent material 147 soaks up the first disinfectant 145 that is housed within the first chamber 141 of the proximal housing 134. In one or more embodiments, the first absorbent material 147 is a nonwoven material, foam, or a sponge. In a specific embodiment, the foam is a polyurethane foam.

[0127] A first peelable seal 131 having a first top web 143 is disposed on the ^ engagement surface 144 of distal housing 135 to prevent the first absorbent material 147 from exiting the first chamber 141. A second peelable seal 157 having a peel tab 158 is disposed on the sealing surface 172 of the integral body 153. With the first absorbent material 147 properly ^P-28177.WO01 PATENT inserted into the first chamber 141 of the proximal housing 134, the first peelable seal 131 may be secured to the engagement surface 144 of the first open distal end 133 of the distal housing 135 to seal the NCDU 130.

[0128] The first peelable seal 131 and second peelable seal 157 minimize entry of^ potential particulate hazard and also provides a substantially impermeable enclosure for the NCDU 130 and the MLDU 150, provide a leak prevention and protection enclosure, protects the contents of first absorbent material 147 contained within the first chamber 141 and the second chamber 168, respectively and / or maintains a sealed, sterilized environment. The first peelable seal 131 provides a sufficient seal at a range of temperatures, pressures, and humidity^ levels. The first peelable seal 131 and second peelable seal 157 may be disposed on the first open distal end 133 of the distal housing 135 and the second open distal end 152 of the integral body 153 to prevent the pre-filled disinfectant 142 from exiting the chamber of the NCDU 130 or the MLDU 150.

[0129] The first peelable seal 131 and second peelable seal 157 can be a plastic sealed^ aluminum, and can be chemically-resistant, light-blocking, non-permeable, or sterile In one or more embodiments, the first peelable seal 131 and second peelable seal 157 comprises an aluminum or multi-layer polymer film peel back top. In a specific embodiment, the first peelable seal 131 and second peelable seal 157 is heat-sealed or induction sealed to the engagement surface of the first open distal end 133 to seal the NCDU 130 the second open^ distal end 152 to seal the ML Disinfecting unit 150 respectively. In one or more embodiments, the first peelable seal 131 and second peelable seal 157 comprise a moisture barrier.

[0130] The first absorbent material 147 and the first disinfectant 145 contacts the male luer connector, the female luer connector, and the hemodialysis connector after insertion of the connector into the first open distal end 133 and the second open distal end 152 of the first^ chamber 141 and second chamber 168.

[0131] In one or more embodiments, the female connector may be selected from the group consisting essentially 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 tubing end, a stopcock or male lock luer. ^

[0132] The proximal housing 134, distal housing 135 and the integral body 153 are made from any type of plastic materials such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, acrylonitrile butadiene styrene or any other moldable 32 ^P-28177.WO01 PATENT plastic material used in medical devices. In one or more embodiments, the proximal housing 134, distal housing 135 and the integral body 153 are comprised of a polypropylene or polyethylene material.

[0133] To avoid having to use different types of disinfecting caps to clean different^ types of connectors, disinfecting device assembly 100 with NCDU 130 and ML Disinfecting unit 150 is compatible and engages with male luer connectors and also with female luer connectors thereby allowing the user to clean different types of connectors with a single device. Upon mounting the NCDU 130 and ML Disinfecting unit 150 onto female luer connectors, or a male luer connector, the female or male medical connector 200 engage the^ interior wall upon insertion into either the first chamber 141 or the second chamber 168 and contact the first absorbent material 147 and into second absorbent material 148 soaked with the first disinfectant 145 and the second disinfectant 146. Hence, the device of the present disclosure can disinfect both male and female luer connectors, thus fulfilling a current need in the art. ^

[0134] Other aspects of the present disclosure are directed to methods of disinfecting medical connectors and assemblies. In one or more embodiments, a method of disinfecting a medical connector comprises connecting the device of one or more embodiments to a medical connector, wherein connecting includes frictionally engaging the interior wall surface upon insertion into a chamber such that the medical connector contacts the first absorbent material^ 147 and the first disinfectant 145.

[0135] In use, a clinician snaps off and removes the NCDU 130 from the syringe assembly and the clinician places the NCDU 130 on a sterile tray for subsequent use of the sealed ML Disinfecting unit 150 for disinfection of NFC before flushing. As discussed above, snap features in the underside of scrubbing device separate from the thumb press of the^ elongate plunger rod 117 of the syringe assembly 110. The clinician peels the first top 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 an IV line. Upon insertion of the NFC into the NCDU 130, the first absorbent material 147 soaked with the first disinfectant 145 contacts the NFC. Next, the clinician removes the proximal housing 134 of the NCDU 130 from the^ syringe barrel, by applying a torque on the entire assembly thus unthreading the NCDU 130 from the locking luer-type collar 120 at the distal end 114 of the syringe barrel 111 to allow attachment of the flush syringe to the IV catheter line to flush the IV line. When a torque is ^P-28177.WO01 PATENT applied to either the syringe or proximal housing 134 or both, the proximal housing 134 of the NCDU 130 should unthread off 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 to the NFC to connect the NFC to the flush syringe. After flushing, the clinician picks up detached NCDU ^^ 130 and peels first peelable seal 131 from distal housing 135 after flushing IV line to expose the first absorbent material 147 soaked in the first disinfectant 145 and disinfects the NFC using the distal housing 135 by contacting the male luer connector, the female luer connector, and the hemodialysis connector after insertion of the NFC connector into distal housing 135 with second absorbent material 148 soaked in the second disinfectant 146. As in current ^^^ practice, the clinician then administers medicine and performs a second flush of the IV line using a Flush syringe to remove any medication left in your catheter and scrubs the hub using a disinfecting wipe or scrubbing device. The clinician then “locks” the IV line using a lock syringe filled with a heparin flush or 4% Sodium Citrate to help prevent blood clots from forming in the catheter. Finally, a new ML Disinfecting unit 150 is attached to the dwelling ^^^ catheter hub.

[0136] As noted above, currently products and SASH practice does not address any cleaning after the initial flushing process as the sanitization ends after the first flush. The benefit of the embodiments of the present invention which includes the two individually packaged NCDU 130 and ML Disinfecting unit 150 both having disinfectant-loaded absorbent ^^^ materials (147, 148) is institution of a two-step sanitization that provides additional protection to the patient by including an additional cleaning step using the IPA or NCDU 130 to sanitize the hub or connecting interface prior to medication or lock solution administration thereby further preventing potential infections to the patient.

[0137] When using the NCDU 130, compression of the first absorbent material 147 ^^^ toward the first closed proximal end 132 of the first chamber 141 upon connection to the female luer connector or the male luer connector allows the connector to contact the first disinfectant 145 to disinfect the female luer connector or the male luer connector. ^P-28177.WO01 PATENT EMBODIMENTS

[0138] Various numbered embodiments are listed below. It will be understood that the embodiments listed below may be combined with all aspects and other embodiments in accordance with the scope of the invention. ^

[0139] Embodiment A. A disinfecting device assembly comprising an integral 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 scrubbing foam disposed within the first cavity; a central post extending from the proximal wall of the integral body and^ positioned within the first cavity; a foam jacket disposed on the central post and defining a second cavity; a central plug disposed in the center of the central post extending from the top wall of the central post and extending into the second cavity of the foam jacket; a second disinfectant or antimicrobial agent, or combinations thereof; a peelable seal disposed on the sealing surface along the open distal end of the integral body; and a rigid top web end cap^ disposed above the peelable seal.

[0140] Embodiment B. The disinfecting device assembly of embodiment (a), wherein upon engagement of the MLDU with a male medical connector, the outer scrubbing foam and foam jacket contacts a thread and an outer surface of the male medical connector.

[0141] Embodiment C. The disinfecting device assembly of embodiment (b), wherein^ when a lumen of the male medical connector is open to the MLDU, the central plug enters the lumen to inhibit disinfectant ingress into the lumen.

[0142] Embodiment D. The disinfecting device assembly of embodiment (a), wherein the outer scrubbing foam comprises an annular wall having a slotted end formed by a plurality of outer slits and a plurality of outer prongs. ^

[0143] Embodiment E. The disinfecting device assembly of embodiment (a)1, wherein the foam jacket comprises an annular wall having a slotted end formed by a plurality of inner slits and a plurality of inner prongs.

[0144] Embodiment F. The disinfecting device assembly of embodiment (a), wherein the central post comprises an annular wall having a slotted end formed by a plurality of slits^ and a plurality of prongs. ^P-28177.WO01 PATENT

[0145] Embodiment G. The disinfecting device assembly of embodiment (a), wherein the central plug is disposed in a central aperture of the central post extending from the top wall of the central post and extending into the second cavity of the foam jacket.

[0146] Embodiment H. The disinfecting device assembly of embodiment (a), wherein ^^ the foam jacket contacts a front tip face, outer surface of Luer and internal thread of the male medical connector when the male medical connector enters the first cavity and second cavity.

[0147] Embodiment I. The disinfecting device assembly of embodiment (a), wherein the outer scrubbing foam contacts a front tip face and outer luer surface of the male medical connector when the male medical connector enters the first cavity and second cavity. ^^^

[0148] Embodiment J. The disinfecting device assembly of embodiment (a), wherein the central plug and central post are joined by a ball and socket joint.

[0149] Embodiment K. The disinfecting device assembly of embodiment (a), wherein an outside geometry of the central plug comprises a frusto-conical tapered surface effective to complement an inner surface of a lumen of the medical connector. ^^^

[0150] Embodiment L. The disinfecting device assembly of embodiment (a), wherein the integral body comprises a polymeric material selected from the group consisting of polyethylene, polypropylene, thermoplastic elastomer (TPE), or combinations thereof.

[0151] Embodiment M. The disinfecting device assembly of embodiment (a), wherein the male medical connector comprises a male Luer connection. ^^^

[0152] Embodiment N. The disinfecting device assembly of embodiment (a), wherein the second disinfectant or the antimicrobial agent is selected from the group consisting essentially 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, antibiotic, and mixtures thereof.

[0153] Embodiment O. The disinfecting device assembly of embodiment (a), wherein the integral body is joined to the thumb press of the syringe assembly by a connecting a ^^^ trapezoidal locking rib with a corresponding trapezoidal receiving undercut in the thumb press.

[0154] Embodiment P. The disinfecting device assembly of embodiment (a), wherein the integral body is joined to the thumb press of the syringe assembly by a press-fitting the ^P-28177.WO01 PATENT integral body into a concentric receiving cup situated above the face of the thumb press of the syringe assembly.

[0155] Embodiment Q. The disinfecting device assembly of embodiment (a), wherein the integral body is joined to the thumb press of the syringe assembly by rotationally engaging^ the grooved face of the thumb press with a taper receiver of the integral body.

[0156] Embodiment R. The disinfecting device assembly of embodiment (a), wherein the integral body is joined to the thumb press by snap-fitting a rim disposed on a peripheral ledge on the proximal wall of the integral body to the face of the thumb press of the syringe assembly. ^

[0157] Embodiment S. The disinfecting device assembly of embodiment (n), wherein the second disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

[0158] Embodiment T. The disinfecting device assembly of embodiment (a), wherein the central post is integrally formed with the distal wall of the integral body. ^

[0159] Embodiment U. The disinfecting device assembly of embodiment (d), wherein the second disinfectant or antimicrobial agent clings between the plurality of outer slits and the plurality of outer prongs.

[0160] Embodiment V. A method of disinfecting a medical connector comprising: placing the disinfecting device assembly of claim (a)onto a male medical connector by^ contacting the distal tip and threads of the medical connector with the outer scrubbing foam and foam jacket and the central plug inhibits disinfectant ingress into a lumen of the medical connector.

[0161] Embodiment W. A medical assembly comprising the disinfecting device assembly of claim (a) connected to a medical connector having a male luer connection. ^

[0162] Embodiment X. A method of manufacturing a disinfecting device assembly by connecting a scrubbing device to the distal end of a syringe assembly by engaging a tip cap with the threading in a threaded locking luer-type collar of the syringe and connecting a disinfecting device assembly to the proximal end of a syringe assembly by attaching the integral body of the ML Disinfecting Unit to the face of a thumb press on the elongate plunger^ rod.

[0163] The embodiments of the present disclosure fulfill a current need by providing a device which disinfects the threaded region of a male luer connector with both passive ^P-28177.WO01 PATENT disinfection and active disinfection while simultaneously reducing or avoiding ingress of disinfectant fluid into the male lumen.

[0164] While the present disclosure has been shown and described with reference to certain exemplary embodiments thereof, it will be understood by those skilled in the art that^ various changes in form and details may be made therein without departing from the spirit and scope of the embodiments of the present disclosure. For example, a disinfection sponge can comprise any suitable disinfecting or other application-specific substance and can be made of any suitable material. Furthermore, any of the features or elements of any exemplary implementations of the embodiments of the present disclosure as described above and ^ illustrated in the drawing figures can be implemented individually or in any combination(s) as would be readily appreciated by skilled artisans without departing from the spirit and scope of the embodiments of the present disclosure.

[0165] In addition, the included drawing figures further describe non-limiting examples of implementations of certain exemplary embodiments of the present disclosure and aid in the^ description of technology associated therewith. Any specific or relative dimensions or measurements provided in the drawings other as noted above are exemplary and not intended to limit the scope or content of the inventive design or methodology as understood by artisans skilled in the relevant field of invention.

[0166] Other objects, advantages and salient features of the disclosure will become^ apparent to those skilled in the art from the details provided, which, taken in conjunction with the annexed drawing figures, disclose exemplary embodiments of the disclosure.

[0167] In one or more embodiments, an assembly comprises the 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 needleless^ connector.

[0168] Other aspects of the present disclosure are directed to methods of disinfecting medical connectors and assemblies. In one or more embodiments, a method of disinfecting a medical connector comprises connecting the device of one or more embodiments to a medical connector, wherein connecting includes frictionally engaging the interior wall surface upon^ insertion into the chamber such that the medical connector contacts the absorbent material and the disinfectant. ^P-28177.WO01 PATENT

[0169] While the present disclosure has been shown and described with reference to certain exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the embodiments of the present disclosure. Also, the inner and / or the outer housing of ^^ the cap can be single shot molded or made by other suitable process. Furthermore, any of the features or elements of any exemplary implementations of the embodiments of the present disclosure as described above and illustrated in the drawing figures can be implemented individually or in any combination(s) as would be readily appreciated by skilled artisans without departing from the spirit and scope of the embodiments of the present disclosure. ^^^

[0170] In addition, the included drawing figures further describe non-limiting examples of implementations of certain exemplary embodiments of the present disclosure and aid in the description of technology associated therewith. Any specific or relative dimensions or measurements provided in the drawings other as noted above are exemplary and not intended to limit the scope or content of the inventive design or methodology as understood by artisans ^^^ skilled in the relevant field of invention.

[0171] Other objects, advantages and salient features of the disclosure will become apparent to those skilled in the art from the details provided, which, taken in conjunction with the annexed drawing figures, disclose exemplary embodiments of the disclosure.

[0172] Reference throughout this specification to "one embodiment," "certain ^^^ embodiments," "one or more embodiments" or "an embodiment" means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Thus, the appearances of the phrases such as "in one or more embodiments," "in certain embodiments," "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily referring to ^^^ the same embodiment of the disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0173] Although the disclosure herein has provided a description with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of ^^^ the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the method and apparatus of ^P-28177.WO01 PATENT the present disclosure without departing from the spirit and scope of the disclosure. Thus, it is intended that the present disclosure include modifications and variations that are within the scope of the appended claims and their equivalents. ^ ^ ^

Claims

P-28177.WO01 PATENT WHAT IS CLAIMED IS:

1. A disinfecting device assembly comprising: a Needleless Connector Disinfecting Unit (NCDU) having a proximal housing, a^ distal housing, a first closed proximal end, 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, the first open distal end having a peripheral ledge extending radially inward from the first open distal end defining an end face and an engagement surface; ^ a first peelable seal disposed on the end face of the distal housing to prevent the first disinfectant from exiting the first chamber; a connection element is disposed on a center of the first closed proximal end of the NCDU; a flush syringe; and ^ a Male Luer Disinfecting Unit (MLDU) having an integral 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 of a male medical connector; ^ a scrubbing foam disposed within the first cavity; a central post extending from the proximal wall of the integral body and positioned within the first cavity; a foam jacket disposed on the central post and defining a second cavity; a central plug disposed in the central post and extending into the second cavity of^ the foam jacket; a second peelable seal disposed on a sealing surface of the integral body to prevent the disinfectant from exiting the second chamber; and ^P-28177.WO01 PATENT a liquid disinfectant or microbial agent, or combinations thereof.

2. The disinfection device assembly of claim 1, wherein the connection element is a threaded post.

3. The disinfection device assembly of claim 2, wherein the connection element is a^ luer lock collar.

4. The disinfection device assembly of claim 2, wherein the threaded post mates with a luer lock collar of the flush syringe.

5. The disinfection device assembly of claim 1, wherein the peripheral ledge is sized and adapted to receive a thumb press of a plunger rod. ^ 6. The disinfection device assembly of claim 1, wherein the proximal housing and distal housing comprise a polypropylene or polyethylene material.

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

8. The disinfection device assembly of claim 7, wherein the first absorbent material is^ a polyurethane foam.

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

10. The disinfection device assembly of claim 1, wherein the first absorbent material has slits. ^ 11. The disinfection device assembly of claim 1, wherein a compression of the first absorbent material toward the first closed proximal end of the first chamber occurs upon connection 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 disinfection device assembly of claim 1, wherein the liquid disinfectant is selected from a group consisting essentially of isopropyl alcohol, ethanol, 2- propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorohexidine, chlorhexidine diacetate,^chlorohexidine gluconate,^ povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, ^P-28177.WO01 PATENT triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotic, and mixtures thereof.

14. The disinfection device assembly of claim 13, wherein the liquid disinfectant comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. ^ 15. The disinfection device assembly of 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 comprise an aluminum or multi-layer polymer film peel back top. ^ 17. The disinfection device assembly of claim 1, wherein the first peelable seal and the second peelable seal are heat-sealed or induction sealed to the engagement surface and the sealing surface respectively.

18. An assembly comprising: the disinfection device assembly of claim 1 connected with a syringe assembly ^ including a syringe barrel having an elongate body defining a chamber, an open proximal end having a flange and a distal end having a tip having a passageway therethrough in fluid communication with the chamber, a stopper connected to an elongate plunger rod having a thumb press at its proximal end, and a locking luer- type collar on the distal end of the syringe barrel; ^ the Needleless Connector Disinfecting Unit (NCDU) connected to the locking luer- type collar on the distal end of the syringe barrel; and the Male Luer Disinfecting Unit (MLDU) is connected to the thumb press of the elongate plunger rod of the syringe assembly.

19. A method of disinfecting a medical connector comprising: ^ connecting the assembly of claim 18 to a medical connector, wherein connecting includes: peeling a top web of the first peelable seal from the distal housing; inserting a needleless connector into the first chamber of the NCDU and contacting a Needleless Connector with the first absorbent material soaked with the^P-28177.WO01 PATENT removing proximal housing of the NCDU from the syringe barrel by applying a torque on the assembly thus unthreading the proximal housing from the locking luer- type collar at the distal end of barrel; attaching a flush syringe to an IV catheter line by engages 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; unthreading the flush syringe from the NFC and peeling the top web from the distal housing to expose the second absorbent material soaked with the second disinfectant; and ^ inserting the male luer connector into the chamber of the distal housing of the MLDU and contacting the male luer connector with the second absorbent material soaked with the second disinfectant.

20. The disinfection device assembly of claim 1, wherein upon engagement of the MLDU with a male medical connector, the scrubbing foam and the foam jacket^ contacts a thread and an outer surface of the male medical connector.

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

22. The disinfection device assembly of claim 1, wherein the scrubbing foam comprises^ an annular wall having a slotted end formed by a plurality of slits and a plurality of prongs.

23. The disinfection device assembly of claim 1, wherein the foam jacket comprises an annular wall having a slotted end formed by a plurality of slits and a plurality of prongs. ^ 24. The disinfection device assembly of claim 1, wherein the central post comprises an annular wall having a slotted end formed by a plurality of slits and a plurality of prongs.

25. The disinfection device assembly of claim 1, wherein the central plug is disposed in an aperture of the central post and extending into the second cavity of the foam^ jacket.

26. The disinfection device assembly of claim 1, wherein the foam jacket contacts a front tip face, outer surface of Luer and internal thread of the male medical ^P-28177.WO01 PATENT connector when the male medical connector enters the first cavity and the second cavity.

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

28. The disinfection device assembly of 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 an outside geometry of the central plug comprises a frusto-conical tapered surface effective to complement an^ inner surface of a lumen of the male medical connector.

30. The disinfection device assembly of claim 1, wherein the proximal housing and distal housing comprise a polymeric material selected from the group consisting of polyethylene, polypropylene, thermoplastic elastomer (TPE), or combinations thereof. ^ 31. The disinfection device assembly of claim 1, wherein the male medical connector comprises a male Luer connection.

32. The disinfection device assembly of claim 1, wherein the liquid disinfectant or antimicrobial agent is selected from a group consisting essentially 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, antibiotic, and mixtures thereof. ^ 33. The disinfection device assembly of claim 32, wherein the liquid disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

34. The disinfection device assembly of claim 1, wherein the central post is integrally- formed with the proximal wall of the integral body. ^ 35. The disinfection device assembly of claim 23, wherein the liquid disinfectant or antimicrobial agent clings between the plurality of slits and the plurality of prongs.

36. A method of disinfecting a medical connector comprising: ^P-28177.WO01 PATENT placing the MLDU of claim 1 onto a male medical connector by contacting a distal tip and threads of the medical connector with the scrubbing foam and the foam jacket and the central plug inhibits disinfectant ingress into a lumen of the male medical connector. ^^ 37. A medical assembly comprising the MLDU of claim 1 connected to a medical connector having a male luer connection.

38. A method of manufacturing a disinfecting device assembly comprising: Connecting a NCDU and a ML Disinfecting Unit to a syringe assembly, wherein the NCDU engages a threaded locking luer-type collar of the syringe assembly ^^^ and the MLDU engages a stopper including a thumb press. ^

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