Sterilizing device and assembly

Abstract

The utility model relates to a disinfection device and an assembly. Integrated disinfection devices are described. The syringe assembly has two integrated disinfection units assembled to the syringe for disinfecting and sterilizing corresponding medical connectors, in particular access ports of corresponding medical connectors. The integrated disinfection unit includes a first cup and a second cup. The first cup has a chamber containing a first absorbent material, a first disinfectant or antimicrobial agent in the first cup, and a first peelable seal. The second cup has a chamber containing a second absorbent material, a second disinfectant or antimicrobial agent in the second cup and a second peelable seal. A threaded connection is disposed on a bottom outer surface of the first cup and has a thread sized and pitch to engage a thread of a Luer locking collar on a distal end of a syringe barrel to allow the first cup to be connected to a syringe assembly. The second cup and the syringe assembly are interlocked by an interference fit or snap fit between the syringe thumb press and the second cup boss.

Description

Technical Field

[0001] The present disclosure is generally directed to an integrated disinfection unit with a scrubbing device having a first cup and a second cup. The first cup includes a unitary body, a closed end, an annular wall extending from the closed end to an open end, and a first peelable seal, the annular wall defining a chamber containing a first absorbent material, a first disinfectant. The second cup includes a unitary body, a closed end, an annular wall extending from the closed end to the open end, and a second peelable seal, the annular wall defining a chamber containing a second absorbent material, a second disinfectant. The present disclosure is also generally directed to a syringe assembly having two integrated disinfection units assembled to a syringe for disinfecting and sterilizing a corresponding medical connector, particularly an access port of the corresponding medical connector. Background Art

[0002] Vascular access devices (VADs) are commonly used therapeutic devices that include intravenous (IV) catheters and needleless access devices. Thrombosis often affects or completely prevents the operation of VADs. Thrombosis refers to the formation of blood clots within the blood vessels and / or vascular access devices. VADs can become contaminated, clotted, or spread infection if not properly maintained or exposed to non-sterile environments. When the VAD is connected to deliver fluids or medications, bacteria and other microorganisms may enter the patient's vascular system from the access hub, port, or valve. Each access hub, port, valve, or connection has a certain risk of spreading catheter-related bloodstream infection (CRBSI), which is not only costly but can also be fatal. To reduce cases of CRBSI and ensure proper use and maintenance of VADs, practice standards have been established, which include disinfection and cleaning procedures. To ensure that VADs are used appropriately and do not become clotted or infected, procedures have been established to ensure aseptic practices. These procedures include sterilizing the VAD and flushing the catheter with flushing solutions. Syringe assemblies filled with various fluids are used to flush the catheter. In some cases, different fluids are injected sequentially according to the procedures. For example, saline solution is used first, followed by an anticoagulant such as heparin. VAD protocols typically recommend flushing procedures after catheter placement, before infusions, and before and after medications, blood draws, transfusions, and parenteral nutrition. The purpose of these flushing procedures is to confirm catheter patency, avoid medication incompatibilities, ensure complete medication dosing, prevent thrombosis, and minimize the risk of bloodstream infection.

[0003] In developed markets, when IV catheters are used, needleless connectors are often used to close the system and then administer medications or other necessary fluids to the patient through the catheter. The Infusion Nurses Society (“INS”) Standards of Practice recommend the use of needleless connectors and state that they should be “continuously and thoroughly disinfected with alcohol, iodine, or a chlorhexidine gluconate / alcohol mixture before each access.” Disinfection of needleless connectors is ultimately intended to help reduce bacteria that may live on the surface and may cause a variety of catheter-related complications, including CRBSI. Nurses typically accomplish this disinfection task using a 70% isopropyl alcohol (IPA) pad using a so-called “scrub hub.” However, compliance with this practice is often low. In addition to noncompliance with the “scrub hub,” clinician interviews noted that scrub times, drying times, and the number of times needleless connectors are scrubbed often vary.

[0004] There are many risks of exposure or contamination throughout the process associated with the transmission of microorganisms that may cause CRBSI. For example, contamination can occur during medication mixing, cannula attachment, and insertion into the access hub. In addition, threaded connectors have open luers with exposed lumen. Because the procedure for connecting to a VAD is so common and simple, the risks associated with accessing a patient's vascular system are often overlooked. Currently, the risk to hospitals and patients is whether the clinician making the connection is doing his or her job diligently, and this diligence is largely uncontrollable.

[0005] VAD standards and practices typically include sterilizing both the threaded male connector and the IV catheter connection. The additional sterilization step reduces the likelihood of contamination, but also increases the likelihood of non-compliance with sterilization procedures.

[0006] Current "recommended practices" for sterile IV line maintenance and IV drug controlled release practices require adherence to a step-by-step process known as "SASH." During the first step of this process, the clinician cleans / disinfects (usually using an alcohol swab) the VAD connector. In the second step, a syringe containing saline is used to flush the IV line or catheter (saline flush), and the VAD connector is then disinfected a second time. In the third step, fluid or drug therapy is administered through the IV line or catheter (infusion therapy), and the VAD connector is disinfected a third time, followed by a second saline flush step. The final step (which depends on the patient's needs and institutional policy) is the final disinfection of the VAD connector followed by a heparin lock step, in which a small amount of heparin is injected into the IV line or catheter to prevent the formation of thrombi or blood clots. A separate disinfection cap can be used to sterilize the hub of the VAD. This "recommended practice" requires disinfection of the VAD connector after each access, making IV line maintenance a very cumbersome and time-consuming process. Because this process is so cumbersome, clinicians are unlikely to fully implement this "recommended practice," and, as a result, patients are at risk for contracting CRBSI. Microorganisms colonize the exposed connector inlet surfaces and can enter the IV line during flushing when "recommended practices" are not followed. In addition, blood backflowing into the IV line or catheter can cause clots to form within the line, and microorganisms from the connector inlet surface can colonize the blood clots within the line and infect the patient during flushing.

[0007] Current practice requires the user to obtain a separate sterilization unit product to ensure the cleanliness of the VAD connector after, for example, a saline flush and before the next procedure (e.g., medication injection). Therefore, there is a need for an integrated sterilization unit assembled to a syringe that facilitates adherence to aseptic technique by eliminating additional wiping and sterilizing steps while reducing the number of separate flushing and sterilizing devices used in current practice.

[0008] Currently, the workflow of sanitizing the hub is performed using only a single device, which is usually an IPA pad or similar IPA scrubbing device. After sanitization, the lines are flushed using a syringe. Afterwards, the drug is infused into the patient. Since IPA pads or scrubbing devices are not available, it is easy to miss the hub sanitization before this infusion. Afterwards, a second flush is performed to clean the lines. If it is integrated with the flush syringe, the IPA pad or scrubbing device is used to clean the hub before use. Finally, the lines are locked using a locking solution (e.g., heparin), but since IPA pads or scrubbing devices are not readily available, the hub is not sanitized before infusion. Current products and practices do not address any cleaning after the flush, as sanitization ends after the flush. INS guidelines also recommend cleaning the connector before each access. Therefore, the current technical solutions on the market do not include an additional scrubbing device to enforce sanitization before the infusion of the drug or locking solution.

[0009] Therefore, it is desirable to provide a device that includes two or more IPA pads or scrubbing devices to sterilize the hub or connection interface prior to drug or lock solution infusion. Utility Model Content

[0010] One aspect of the present disclosure relates to a disinfection device for connecting to a medical connector. According to an exemplary embodiment of the present disclosure, the disinfection device generally includes a scrubbing device having a first cup and a second cup and a bottom wall spanning the entire first cup and the second cup.

[0011] The first cup includes a one-piece body, a closed end, and a central portion extending from the closed end to the open end with a length L C The invention relates to an annular wall and a first peelable seal having a top web, the annular wall defining a chamber containing a first absorbent material, a first disinfectant or an antimicrobial agent. The first peelable seal has a bottom surface and a top surface.

[0012] The second cup includes a unitary body, a closed end, an annular wall extending from the closed end to the open end with a length LC, and a second peelable seal having a top web, the annular wall defining a chamber for containing a second absorbent material, a second disinfectant or an antimicrobial agent in the second cup, the closed end of the annular wall having a boss extending from the closed end. The second absorbent material is soaked in the second disinfectant or an antimicrobial agent.

[0013] The open end of the first cup defines an engagement surface that contacts a bottom surface of the first peelable seal, and the open end of the second cup defines an engagement surface that contacts a top surface of the second peelable seal.

[0014] The connecting element is arranged on the bottom wall of the scrubbing device, thereby allowing it to be connected to the syringe. In one or more embodiments, the syringe assembly can be attached to the scrubbing device by using various methods, including but not limited to mechanical fasteners, snap fit and threaded connection. In one or more embodiments, the connecting element is a threaded connection and can include an integrated thread or a tongue. In a specific embodiment, the connecting element is a Luer threaded connection. In one or more embodiments, the threaded connection is arranged on the bottom outer surface of the first cup of the disinfection unit and has a thread, and the thread size and pitch are made into a thread of the Luer locking collar on the far end of the syringe barrel to allow the first cup to be connected to the syringe. In one or more embodiments, the bottom wall of the first cup of the scrubbing device includes a threaded column arranged in the center of the bottom wall of the first cup, which corresponds to the internal thread of the locking Luer type collar on the far end of the syringe barrel.

[0015] The second cup and the syringe assembly are interlocked by an interference fit or snap fit between the syringe thumb press and the boss of the second cup. A boss or wedge can be provided at the closed end of the annular wall of the second cup to provide a snap fit connection with the thumb press of the syringe assembly. The interior surface of the top wall of the second cup, which is placed at the closed end of the annular wall of the second cup, can have a groove, boss or wedge into which the thumb press can be inserted.

[0016] In one or more embodiments, the closed end of the annular wall of the second cup includes a peripheral sidewall extending radially inward from the annular wall in a vertical direction. The second cup is adapted to be snap-fitted over a thumb press of the plunger rod opposite the Luer tip. In one or more embodiments, the second cup can be connected to a thumb press having a rim that is placed on the peripheral boss and radially inward to create a lip or rim.

[0017] In one or more embodiments, the inner surface of the peripheral boss in the inner annular wall surface of the second cup at the closed end includes at least two or more mating protrusions that allow the thumb press to mate with the second cup via a snap-fit ​​connection.

[0018] When used on a needleless connector ("NFC"), the scrubbing device can achieve disinfection by integrating a first disinfectant or antimicrobial agent in a first absorbent material placed in and contained in a first chamber of a cup, and integrating a second disinfectant or antimicrobial agent in a second absorbent material placed in and contained in a second chamber of a second cup. The first and second disinfectants or antimicrobials can be directly included in the first and second chambers, and can be absorbed into the first and second absorbent materials (e.g., sponges or foam materials) that fill the chambers of the first and second cups, respectively. The scrubbing device is designed to be compatible with a variety of disinfectants. In one or more embodiments, the first disinfectant or antimicrobial agent or the second disinfectant or antimicrobial agent can include various alcohols or chlorhexidine. In one or more embodiments, the first disinfectant or antimicrobial agent or the second disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylhydroxyanisole (BHA), butylhydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate diacetate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexidine, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, octenylamine, antibiotics and mixtures thereof. In a specific embodiment, the first disinfectant or antimicrobial agent or the 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 the second disinfectant or antimicrobial agent is a fluid or a gel.

[0019] The first absorbent material absorbs the first disinfectant or antimicrobial agent contained within the chamber of the cup. In one or more embodiments, the first absorbent material is a nonwoven material, a 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.

[0020] A first peelable seal having a top web is placed on the engagement surface of the cup to prevent the first absorbent material from leaving the chamber. With the first absorbent material properly inserted into the chamber of the cup, the first peelable seal can be secured to the engagement surface of the open end of the first cup to seal the scrubbing device.

[0021] The second absorbent material is placed and contained in the chamber of the cup and absorbs the second disinfectant or antimicrobial agent contained in the chamber of the second cup. In one or more embodiments, the second absorbent material is a nonwoven material, foam or 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.

[0022] A second peelable seal having a top web is placed on the engagement surface of the cup to prevent the second absorbent material from leaving the chamber. With the second absorbent material properly inserted into the chamber of the cup, the second peelable seal can be secured to the engagement surface of the open end of the second cup to seal the scrubbing device.

[0023] The first peelable seal and the second peelable seal can be chemically resistant, light-proof, non-permeable or sterile. In one or more embodiments, the first peelable seal and the second peelable seal include aluminum or a multi-layer polymer film peelable top layer. In a specific embodiment, the first peelable seal and the second peelable seal are heat sealed or induction sealed to the engaging surfaces of the open ends of the first cup and the second cup to seal the scrubbing device. In one or more embodiments, the first peelable seal and the second peelable seal include a moisture barrier.

[0024] The first cup and the second cup are made of any type of plastic material, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactic acid, acrylonitrile-butadiene-styrene or any other moldable plastic material used in medical devices. In one or more embodiments, the first cup and the second cup include polypropylene or polyethylene materials.

[0025] Another aspect of the present disclosure relates to an assembly comprising a scrubbing device of a disinfection device according to one or more embodiments connected to a syringe assembly. The syringe assembly comprises a syringe barrel having an elongated body defining a chamber, an open proximal end having a flange, and a distal end having a tip having a passage in the tip that is in fluid communication with the chamber. The distal end of the barrel also comprises a locking Luer-type collar concentrically surrounding the tip. The locking Luer-type collar has an internal thread. The syringe assembly further comprises a stopper connected to an elongated plunger rod having a thumb press at its proximal end. In one or more embodiments, the assembly may further comprise a medical connector selected from a male Luer connector, a female Luer connector, and a needleless connector.

[0026] Another aspect of the present disclosure relates to a method for disinfecting a medical connector, the method comprising: connecting a disinfection device according to an embodiment of the present disclosure to a medical connector, wherein the connection comprises removing a second cup from a syringe assembly, peeling off a top web of a first peelable seal from a first cup; inserting a needleless connector ("NFC") into a chamber of the first cup and bringing the NFC into contact with a first absorbent material soaked in a disinfectant or antimicrobial agent; then, removing the first cup of the scrubbing device from a syringe barrel by applying torque to the entire assembly, thereby unscrewing the scrubbing device from a locking Luer-type collar at a distal end of the barrel; connecting the NFC to a flushing syringe by engaging the threads of the Luer-lock collar on the distal end of the syringe barrel, connecting the flushing syringe to an IV catheter line, and flushing the IV line; unscrewing the flushing syringe from the NFC, and peeling off the top web from the second cup to expose a second absorbent material soaked in a second disinfectant, inserting the NFC into the chamber of the first cup and bringing the NFC into contact with the first absorbent material soaked in a disinfectant or antimicrobial agent.

[0027] In one or more embodiments, the disinfection device comprises:

[0028] a scrubbing device having a first cup, a second cup, and a bottom wall spanning across the first cup and the second cup,

[0029] The first cup includes a first unitary body, a first closed end, a first annular wall extending from the first closed end to a first open end having a length LC and defining a first chamber containing a first absorbent material and a first disinfectant, the first open end having a peripheral boss extending radially inwardly from the first open end to define an end face and an engagement surface;

[0030] a first peelable seal disposed on the end surface of the first cup to prevent the first disinfectant from leaving the first chamber;

[0031] a connecting element disposed on the bottom wall of the first cup of the scrubbing device;

[0032] the second cup comprising a second unitary body, a second closed end, a second annular wall extending from the second closed end to a second open end having a length LC and defining a second chamber containing a second absorbent material and a second disinfectant, the second open end having a peripheral boss extending radially inwardly from the second open end to define a second end face and a second engagement surface; and

[0033] A second peelable seal is disposed on the second end surface of the second cup to prevent the second disinfectant from leaving the second chamber.

[0034] In one or more embodiments, it is characterized in that the connecting element is a threaded stud.

[0035] In one or more embodiments, it is characterized in that the connecting element is a Luer lock collar.

[0036] In one or more embodiments, the threaded post is characterized in that it cooperates with a Luer lock collar of a flushing syringe.

[0037] In one or more embodiments, the peripheral boss is sized and adapted to receive a thumb press portion of a plunger rod.

[0038] In one or more embodiments, it is characterized in that the first cup and the second cup include polypropylene or polyethylene material.

[0039] In one or more embodiments, it is characterized in that the first absorbent material and the second absorbent material are foams.

[0040] In one or more embodiments, it is characterized in that the first absorbent material and the second absorbent material are polyurethane foams.

[0041] In one or more embodiments, it is characterized in that the first absorbent material and the second absorbent material are sponges.

[0042] In one or more embodiments, it is characterized in that the first absorbent material and the second absorbent material have slits.

[0043] In one or more embodiments, it is characterized in that upon connection to the medical connection head, compression of the first and second absorbent materials towards the first closed ends of the first and second chambers occurs.

[0044] In one or more embodiments, the feature is that contact with the first absorbent material and the second absorbent material sterilizes the medical connection head.

[0045] In one or more embodiments, the first disinfectant and the second disinfectant are selected from the group consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylhydroxyanisole (BHA), butylhydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate diacetate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexidine, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, octenylamine, antibiotics and mixtures thereof.

[0046] In one or more embodiments, it is characterized in that the first disinfectant and the second disinfectant include at least one of chlorhexidine gluconate and chlorhexidine diacetate.

[0047] In one or more embodiments, it is characterized in that the first disinfectant and the second disinfectant are fluids or gels.

[0048] In one or more embodiments, it is characterized in that the first peelable seal and the second peelable seal include aluminum or a multi-layer polymer film peelable top layer.

[0049] In one or more embodiments, it is characterized in that the first peelable seal and the second peelable seal are heat or induction sealed to the joining surface.

[0050] In one or more embodiments, the assembly includes:

[0051] a disinfection unit connected to a syringe assembly including a syringe barrel having an elongated body defining a chamber, an open proximal end having a flange, and a distal end having a tip having a passage therein in fluid communication with the chamber, a stopper connected to an elongated plunger rod, and a locking Luer-type collar on a distal end of the syringe barrel, the syringe barrel having an elongated body defining a chamber, an open proximal end having a flange, and a distal end having a tip having a passage therein in fluid communication with the chamber, the elongated plunger rod having a thumb press at its proximal end;

[0052] The first cup is connected to the locking Luer-type collar on the distal end of the syringe barrel; and

[0053] The second cup of the scrubbing device is snap-fitted to the thumb press portion of the elongated plunger rod of the syringe assembly.

[0054] This Summary is provided to introduce a selection of concepts in a simplified form, which are further described in the Detailed Description below. 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.

[0055] Other features and advantages of the present disclosure will be set forth in the following description, some of which will be apparent from the description or may be learned through the practice of the present disclosure. The features and advantages of the present disclosure may be realized and obtained through the apparatus and combinations specifically indicated in the appended claims. These and other features and advantages of the present disclosure may become more apparent from the following description and the appended claims or may be learned through the practice of the present disclosure as presented later. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Figure 1 shows a perspective view of a disinfection unit 100 according to an exemplary first embodiment of the present disclosure;

[0057] Figure 2 shows a cross-sectional view of a disinfection unit 100 according to an exemplary first embodiment of the present disclosure;

[0058] Figure 3 shows an exploded perspective view of a disinfection unit 100 according to an exemplary first embodiment of the present disclosure;

[0059] Figure 4 shows a bottom perspective view of a scrubbing element according to an exemplary first embodiment of the present disclosure;

[0060] Figure 5 shows a top perspective view of a scrubbing element according to an exemplary first embodiment of the present disclosure;

[0061] Figure 6 A flow chart showing a sterilization process using the sterilization unit 100 according to the exemplary first embodiment of the present disclosure;

[0062] Figure 7 shows a perspective view of a disinfection unit 200 according to an exemplary second embodiment of the present disclosure;

[0063] Figure 8 shows a cross-sectional view of a disinfection unit 200 according to an exemplary second embodiment of the present disclosure;

[0064] Fig. 9 shows an exploded perspective view of a disinfection unit 200 according to an exemplary second embodiment of the present disclosure;

[0065] Fig.10 shows a side perspective view of a scrubbing element according to an exemplary second embodiment of the present disclosure;

[0066] Fig.11 shows a perspective view of a scrubbing element according to an exemplary second embodiment of the present disclosure, wherein a second cup is removed from a first cup;

[0067] Fig.12 A flow chart showing a sterilization process using the sterilization unit 200 according to the exemplary second embodiment of the present disclosure;

[0068] Fig.13 shows a perspective view of a disinfection unit 300 according to an exemplary third embodiment of the present disclosure;

[0069] Fig.14 shows a cross-sectional view of a disinfection unit 300 according to an exemplary third embodiment of the present disclosure;

[0070] Fig.15 shows an exploded perspective view of a disinfection unit 300 according to an exemplary third embodiment of the present disclosure;

[0071] Fig.16 shows a side perspective view of a scrubbing element according to an exemplary third embodiment of the present disclosure;

[0072] Fig.17 shows a perspective view of a scrubbing element according to an exemplary third embodiment of the present disclosure, wherein a second cup is removed from a first cup;

[0073] Fig.18 1 shows a flow chart of a disinfection process using the disinfection unit 200 according to the exemplary third embodiment of the present disclosure;

[0074] Fig.19 shows a perspective view of a disinfection unit 400 according to an exemplary fourth embodiment of the present disclosure;

[0075] Fig. 20 shows a cross-sectional view of a disinfection unit 400 according to an exemplary fourth embodiment of the present disclosure;

[0076] Fig.21 shows an exploded perspective view of a disinfection unit 400 according to an exemplary fourth embodiment of the present disclosure;

[0077] Fig. 22 showing a side perspective view of first and second cups of a scrubbing element according to an exemplary fourth embodiment of the present disclosure;

[0078] Fig.23 1 shows a flow chart of a disinfection process using a disinfection unit 400 according to an exemplary fourth embodiment of the present disclosure;

[0079] Fig.24 shows a perspective view of a disinfection unit 500 according to an exemplary fifth embodiment of the present disclosure;

[0080] Fig.25 shows a cross-sectional view of a disinfection unit 500 according to an exemplary fifth embodiment of the present disclosure;

[0081] Fig.26 shows an exploded perspective view of a disinfection unit 500 according to an exemplary fifth embodiment of the present disclosure;

[0082] Fig. 27 shows a side perspective view of a scrubbing element according to an exemplary fifth embodiment of the present disclosure;

[0083] Fig.28 shows a perspective view of a scrubbing element according to an exemplary fifth embodiment of the present disclosure, wherein a second cup is removed from a first cup;

[0084] Fig.29 A flow chart showing a sterilization process using a sterilization unit 500 according to an exemplary fifth embodiment of the present disclosure;

[0085] Fig.30 A perspective view showing a disinfection unit 600 according to an exemplary sixth embodiment of the present disclosure; and

[0086] Fig.31 A perspective view of a sterilization unit 700 according to an exemplary seventh embodiment of the present disclosure is shown. DETAILED DESCRIPTION

[0087] In the current practice of the SASH (Saline Administration Saline Heparin) workflow, the clinician removes the sterile cap attached to the hub of the resident catheter to be flushed and uses a sterile wipe or scrub device to scrub the hub. The clinician then uses a flush syringe to flush the intravenous (IV) line to ensure that the catheter is functioning properly before infusion. After the first flush, the clinician then uses a sterile wipe or scrub device to scrub the hub and infuse medication in the IV line. After medication, the clinician again uses a sterile wipe or scrub device to scrub the hub. The clinician then uses a flush syringe to flush the IV line a second time to remove any medication left in your catheter and scrubs the hub using a sterile wipe or scrub device. The clinician then uses a locking syringe filled with heparin flush to then "lock" the IV line to help prevent blood clots from forming in the catheter. Finally, a new sterile cap is attached to the resident catheter hub. Therefore, current practice requires 4 scrub devices, 2 flush syringes, 1 sterile cap, and 1 locking syringe.

[0088] Before describing several exemplary embodiments of the present disclosure, it should be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description. The present invention is capable of other embodiments and being implemented or carried out in various ways.

[0089] Embodiments of the present disclosure relate to a disinfection unit for connecting to a medical connector, which includes a syringe assembly and has two integrated disinfection units assembled to the syringe assembly for connecting to and disinfecting corresponding medical connectors, including threaded connectors. In one or more embodiments, the connector is a male Luer connector or a female Luer connector. The present disclosure is intended to provide a mechanism that can disinfect both the inner cavity of the open Luer and the corresponding IV connector while minimizing additional steps in medical infusion. It is conceivable that the disinfection unit disclosed herein can be used with a male threaded connector or a female threaded connector. The present disclosure is intended to provide a mechanism for disinfecting an IV needleless connector during use of a syringe, thereby saving clinicians time and reducing work steps. The present disclosure is intended to reduce the number of steps required to prevent contamination of a vascular access device (VAD).

[0090] With respect to terms used in this disclosure, the following definitions are provided.

[0091] As used herein, the use of "a", "an" and "the" includes both the singular and the plural.

[0092] 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.

[0093] As used herein, the term "Luer connector" refers to a connecting collar that is a standard way to interconnect syringes, catheters, hubbed needles, IV tubing, etc. The Luer connector consists of male and female interlocking tubes that taper slightly to hold together with a simple press / twist fit. The Luer connector can optionally include an additional threaded outer rim to make it more secure. The male end of the Luer connector is generally combined with a flush syringe and can interlock and connect to the female end located on the vascular access device (VAD). The Luer connector includes a distal end, a proximal end, an irregularly shaped outer wall, and a shaped central passageway for fluid communication from the chamber of the barrel of the syringe to the hub of the VAD. The Luer connector also has a distal channel that removably attaches the Luer connector to the hub of the VAD and a proximal channel that removably attaches the Luer connector to the barrel of the syringe.

[0094] As used herein, the term "syringe" refers to a simple pump-like device consisting of a plunger rod that fits tightly within a barrel or tube. The plunger rod can be pulled or pushed along the inside of the barrel, allowing the syringe to draw and discharge liquid or gas through an opening at the open end of the barrel. In one or more embodiments, the syringe is a flushing syringe filled with a flushing solution.

[0095] A "pre-filled syringe assembly" includes a syringe whose barrel is filled with a solution or medicament using an aseptic filling method during or after assembly of the syringe prior to delivery to a user. Pre-filled syringe assemblies include syringe assemblies indicated for flushing a vascular access device (VAD).

[0096] As used herein, the term "medical device" refers to a common medical device having a threaded or interlocking connection with a corresponding mating element. For example, but not limited to, a syringe has a male threaded connection that releasably interlocks with a secondary medical device (e.g., a female Luer connection of a catheter, IV line, etc.). The threaded connection includes an inner cavity defining a fluid path surrounded by a protruding wall, which has a threaded device to attach to the secondary medical device.

[0097] As used herein, the term "disinfectant" includes antimicrobial agents.

[0098] As will be apparent to those skilled in the relevant art, although descriptive terms such as "thread," "tab," "wall," "top," "side," "bottom" and others are used throughout this specification to facilitate understanding, they are not intended to limit any components that can be used in combination or individually to implement various aspects of the embodiments of the present disclosure.

[0099] The matters illustrated in this specification are provided to help fully understand the exemplary embodiments of the present disclosure. Therefore, those of ordinary skill in the art will recognize that various changes and modifications may be made to the embodiments described herein without departing from the scope and spirit of the present disclosure. In addition, for the sake of clarity and brevity, descriptions of well-known functions and configurations are omitted. Before describing several exemplary embodiments of the present disclosure, it should be understood that the present disclosure is not limited to the details of the configurations or process steps set forth in the following description. The utility model can have other embodiments and be implemented or executed in various ways.

[0100] Clinicians need to manipulate multiple components when accessing an IV line or catheter as they need to open and sterilize the hub, open the syringe, hold the line in place, etc., while ensuring that no device touches any surface, which could result in contamination and bloodstream infection with potentially fatal consequences. Accessing an IV line or catheter is therefore not simple and requires a certain amount of dexterity to complete the procedure while preventing the syringe tip from coming into contact with the surrounding environment. If the syringe tip comes into contact with any non-sterile surface, "contact" contamination can occur, which can lead to microbial growth in the IV line and thus cause catheter-related bloodstream infection (CRBSI) and central line-associated bloodstream infection (CLABSI), which are costly and fatal.

[0101] Embodiments of the present disclosure relate to a disinfection unit comprising a pre-filled syringe assembly having two integrated disinfection units assembled to the syringe. The disinfection unit provides a means of mechanical and chemical disinfection, namely a scrubbing unit (foam, etc.) and a chemical disinfectant (alcohol, etc.).

[0102] The flush syringe contains a flush solution, such as saline or other medication, for the product shelf life and can deliver such saline during use, i.e., the syringe is connected to a hub (such as a needleless connector or the like) and the syringe contents are delivered.

[0103] The sterilization unit provides a means to sterilize the hub by providing mechanical and chemical sterilization. The sterilization unit contains a chemical sterilant (eg isopropyl alcohol 70%) during the shelf life of the product.

[0104] As discussed below, embodiments of the present disclosure allow the disinfection unit to be non-permanently connected to the syringe unit for performing disinfection and the following flushing process with a standard SASH procedure. Embodiments of the present disclosure provide non-permanent mechanical or chemical means (e.g., adhesive) for connecting the disinfection unit to the syringe. Embodiments of the present disclosure engage the disinfection unit and the syringe tip or thumb press on the assembly line by using an adhesive, threaded connection, or flexible element (e.g., clip) on the syringe or disinfection unit. Threaded connections or flexible elements (e.g., clips, tabs, etc.) can be placed on either the disinfection unit or the syringe (engaged in corresponding mating features on the other component, locked, and once the disinfection unit and the syringe tip cap are assembled, they are prevented from disengaging until the clinician needs to use them). In one or more embodiments, an adhesive can be applied to the contact surface between the two disinfection units so as to bond the two disinfection units and prevent disengagement until the clinician needs to use them).

[0105] Referring now to the drawings, wherein like reference numerals designate like or corresponding parts throughout the several views, embodiments of the present disclosure are described as follows.

[0106] refer to Figure 1-6 The disinfection unit 100 for connecting to a medical connection head according to the first exemplary embodiment of the present disclosure generally includes a scrubbing device 130 having a first cup 140 and a second cup 150. A bottom wall 131 spans across the first cup 140 and the second cup 150.

[0107] refer to Figure 1 , an assembly for connecting to a medical connector includes a syringe assembly 110 having a syringe barrel 111 having an elongated body 112 defining a chamber 113 for holding a fluid. Figure 4 , the syringe barrel 111 includes an open proximal end 114 having a flange 115 and a distal end 116 including a tip 117 having a passage 118 therein for fluid communication with the chamber. The distal end 116 of the barrel also includes a locking Luer-type collar 119 concentrically surrounding the tip 117. The locking Luer-type collar 119 has internal threads 120. The syringe assembly 110 further includes a stopper 121 connected to an elongated plunger rod 122 having a thumb press 123 at its proximal end.

[0108] refer to Figure 1-5 The first cup 140 includes an integral body 141, a closed end 142, and a central portion 144 extending from the closed end 142 to the open end 144 having a length L CThe first cup 140 has an annular wall 143 and a first peelable seal 148, the annular wall 143 defining a chamber 145 containing a first absorbent material 146 and a first disinfectant in the first cup 140. The first absorbent material 146 is soaked in the first disinfectant. The open end 144 defines a bonding surface that contacts the first peelable seal 148 having a top web 149. Figure 1 and Figure 5 The annular wall 143 of the first cup 140 includes an outer wall surface 143E and an inner wall surface 143I. The inner wall surface 143I defines an opening adjacent to the open end 144.

[0109] refer to Figure 1-6 The second cup 150 includes an integral body 151, a closed end 152, and a body 154 extending from the closed end 152 to the open end 154 with a length L C The second cup 150 has an annular wall 153 and a second peelable seal 158 having a top web 159, the annular wall 153 defining a second chamber 155 containing a second absorbent material 156 and a second disinfectant 157 in the second cup 150. The second absorbent material 156 is soaked in the second disinfectant 157 or antimicrobial agent. The open end 154 defines a bonding surface that contacts the second peelable seal 158. Figure 1 and Figure 5 The annular wall 153 of the second cup 150 includes an outer wall surface 153E and an inner wall surface 153I. The inner wall surface 153I defines an opening adjacent to the open end 154.

[0110] The first cup 140 and the second cup 150 are arranged in a side-by-side orientation, and the first cup 140 and the second cup 150 are bounded or limited by a common dividing wall 160 .

[0111] like Figure 1-3 As shown, the syringe assembly 110 can be attached to a scrubber 130 having mechanical mating features. Once assembled, the assembly formed by the syringe assembly 110 and the scrubber 130 can withstand, for example, axial forces, radial forces, and disassembly forces. In order to remove the scrubber 130 from the syringe barrel, the user needs to apply torque to the entire assembly to unscrew the scrubber 130 from the locking Luer-type collar 119 at the distal end of the barrel to allow the flushing syringe to be attached to the IV catheter line. When torque is applied to either or both of the syringe or the scrubber 130, the scrubber 130 will be unscrewed from the barrel.

[0112] In the prior art, a "stand" bottom surface is used to hold the disinfection unit underneath so that the user can easily remove the stand during normal use. The assembly of the scrubbing device 130 and the collar of the syringe of the present disclosure does not require a separate "stand" or other device to assemble the device together.

[0113] exist Figure 1-3 In one or more embodiments shown in the drawings, the mechanical mating and assembly features ensure that the device can be assembled in an automated process and ensure the integrity of the device during transportation, use, and the entire service life of the product. The assembly of the scrubbing device 130 and the collar of the syringe, which is realized via a mechanical connection or a threaded connection, facilitates rapid automated assembly.

[0114] Compared to existing separate flush syringe and disinfection unit products, embodiments of the integrated disinfection unit of the present disclosure provide easier access to disinfection products at each flush and easier manual operation during disinfection prior to flushing.

[0115] In one or more embodiments, the disinfection unit 100 includes a connecting element to allow it to be connected to a syringe. In one or more embodiments, the connecting element is a threaded connection, such as a Luer threaded connection, to allow the assembled disinfection unit 100 to be connected to a syringe. In an exemplary embodiment of an embodiment of the present disclosure, the disinfection unit 100 includes integrated threads or tabs and other features that allow the disinfection unit 100 to interface with threaded fittings of a medical device in any and all combinations. In one or more embodiments, the syringe assembly 110 can be attached to the scrubbing device 130 using a variety of methods, including but not limited to mechanical fasteners, snap fits, and threaded connections. In one or more embodiments, the threaded connection is arranged on the bottom outer surface of the disinfection unit 100 and has threads sized and pitched to engage the threads of a Luer lock collar on the distal end of the syringe barrel to allow the assembled disinfection element 100 to be connected to a syringe. In Figure 1 In one or more embodiments shown in , the bottom wall 131 of the scrubbing device 130 includes a threaded post 132 disposed at the center of the bottom wall 131, adjacent to a common dividing wall 160, which corresponds to the internal threads 120 of the locking Luer-type collar 119 on the distal end of the syringe barrel 111. In one or more alternative embodiments, the dividing wall 160 can divide a single cup into two separate cups.

[0116] refer to Figure 6When used on a needleless connector ("NFC") medical connector 900, the scrubbing device 130 can achieve disinfection by integrating a first disinfectant 147 in a first absorbent material 146 placed and contained in a first chamber 145 of a first cup 140, and integrating a second disinfectant 157 in a second absorbent material 156 placed and contained in a second chamber 155 of a second cup 150. The first disinfectant (147) and the second disinfectant (157) can be directly included in the first chamber 145 and the second chamber 155, respectively, and can be absorbed into the first absorbent material 146 and the second absorbent material 156 (e.g., sponge or foam material) filling the chambers of the first cup 140 and the second cup 150, respectively. The scrubbing device 130 is designed to be compatible with various disinfectants. In one or more embodiments, the first disinfectant 147 or the second disinfectant 157 can include various alcohols or chlorhexidine. In one or more embodiments, the first disinfectant 147 or the second disinfectant 157 is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylhydroxyanisole (BHA), butylhydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate diacetate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexidine, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, octenylamine, antibiotics, and mixtures thereof. In a specific embodiment, the first disinfectant 147 or the second disinfectant 157 includes at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the first disinfectant 147 or the second disinfectant 157 is a fluid or a gel.

[0117] The first absorbent material 146 absorbs the first disinfectant 147 or antimicrobial agent contained in the chamber 145 of the first cup 140. In one or more embodiments, the first absorbent material 146 is a nonwoven material, a foam, or a sponge. In a particular embodiment, the foam is a polyurethane foam. In a particular embodiment, the second absorbent material 156 is in the form of a foam plug. In one or more embodiments, the second absorbent material 156 includes one or more slits, such as Figure 3 and Figure 5 shown.

[0118] A first peelable seal 148 having a top web 149 is placed on the engagement surface of the first cup 140 to prevent the first absorbent material 146 from leaving the chamber 145. With the first absorbent material 146 properly inserted into the chamber 145 of the first cup 140, the first peelable seal 148 can be secured to the engagement surface of the open end 144 of the first cup 140 to seal the scrubbing device 130.

[0119] The second absorbent material 156 is disposed and contained within the second chamber 155 of the second cup 150 and absorbs the second disinfectant 157 or antimicrobial agent contained within the second chamber 155 of the second cup 150. In one or more embodiments, the second absorbent material 156 is a nonwoven material, a foam, or a sponge. In a particular embodiment, the foam is a polyurethane foam. In a particular embodiment, the second absorbent material 156 is in the form of a foam plug. In one or more embodiments, the second absorbent material 156 includes one or more slits, such as Figure 2-6 shown.

[0120] A second peelable seal 158 having a top web 159 is placed on the engagement surface of the second cup 150 to prevent the second absorbent material 156 from leaving the second chamber 155. With the second absorbent material 156 properly inserted into the second chamber 155 of the second cup 150, the second peelable seal 158 can be secured to the engagement surface of the open end 154 of the second cup 150 to seal the scrubbing device 130.

[0121] The first peelable seal 148 and the second peelable seal 158 minimize the ingress of potentially hazardous particles and provide a substantially impermeable enclosure for the scrubbing device 130, providing a leak-proof and protective enclosure to protect the contents of the first absorbent material 146 and the second absorbent material 156 contained in the first chamber 145 and the second chamber 155, respectively, and / or maintain a sealed sterile environment. The first peelable seal 148 and the second peelable seal 158 provide an adequate seal over a range of temperatures, pressures, and humidity levels. Figure 1 , a first peelable seal 148 and a second peelable seal 158 can be placed on the respective open ends (144, 154) of the first cup 140 and the second cup 150 to prevent the pre-filled first and second disinfectants (147, 157) from leaving the respective chambers of the first cup 140 and the second cup 150.

[0122] The first peelable seal 148 and the second peelable seal 158 can be plastic sealed aluminum and can be chemically resistant, lightproof, non-permeable or sterile. In one or more embodiments, the first peelable seal 148 and the second peelable seal 158 include aluminum or a multi-layer polymer film peelable top layer. In a specific embodiment, the first peelable seal 148 and the second peelable seal 158 are heat sealed or induction sealed to the engaging surfaces of the open ends (144, 154) of the first and second cups (140, 150) to seal the scrubbing device 130. In one or more embodiments, the first peelable seal 148 and the second peelable seal 158 include a moisture barrier.

[0123] After the male Luer, female Luer, and hemodialysis connectors are inserted into the open ends (144, 154) of the respective cups 140 and 150, the first and second absorbent materials 146, 156 and the disinfectant or antimicrobial agent contact the connectors.

[0124] In one or more embodiments, the female connector can be selected from the group consisting of a needleless connector, a catheter Luer connector, a stopcock, and a hemodialysis connector. In one or more embodiments, the male connector can be an IV tubing end, a stopcock, or a male locking Luer.

[0125] The first cup 140 and the second cup 150 are made of any type of plastic material, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactic acid, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the first cup 140 and the second cup 150 include polypropylene or polyethylene materials.

[0126] In order to avoid having to use different types of disinfection caps to clean different types of connectors, the disinfection device 100 with the first cup 140 and the second cup 150 is compatible and engageable with the male Luer connector and also with the female Luer connector, thereby allowing the use of a single device to clean different types of connectors. Once the first cup 140 and the second cup 150 are installed on the female Luer connector or the male Luer connector, the female or male medical connector engages the inner wall when inserted into the first chamber 145 or the second chamber 155 and contacts the first absorbent material 146 and the second absorbent material 156 soaked with a disinfectant or antimicrobial agent. Therefore, the device of the present disclosure is capable of disinfecting both male and female Luer connectors, thereby meeting the needs of the current technical field.

[0127] Other aspects of the present disclosure relate to methods of disinfecting medical connectors and assemblies. In one or more embodiments, the method of disinfecting a medical connector includes connecting a device according to one or more embodiments to the medical connector, wherein the connection includes frictionally engaging an interior wall surface once inserted into a cavity so that the medical connector contacts the absorbent material and the disinfectant or antimicrobial agent.

[0128] In use, the clinician peels off the top web 149 of the first peelable seal 148 from the first cup 140 before flushing the IV line. The clinician then uses the first cup 140 to disinfect the NFC. Once the NFC is inserted into the first cup 140, the first absorbent material 146 soaked with the first disinfectant 147 contacts the NFC. In one or more embodiments, the NFC can be a male Luer connector, a female Luer connector, or a hemodialysis connector. Afterwards, by applying torque to the entire assembly, the scrubbing device 130 is unscrewed from the locking Luer type collar 119 at the distal end of the barrel 111, and the clinician removes the scrubbing device 130 from the syringe barrel to allow the flushing syringe to be attached to the IV catheter line to flush the IV line. The clinician places the first cup 140 on a sterile tray for subsequent use of the second cup, and the thread of the Luer lock collar on the distal end of the syringe barrel is engaged to the NFC so that the NFC is connected to the flushing syringe. The clinician continues to flush the IV line afterwards. Then, after flushing the IV line, the clinician picks up the separate scrubbing device 130 and peels off the top web 159 from the second cup 150 to expose the second absorbent material 156 soaked with the second disinfectant 157 and uses the second cup 150 to disinfect the NFC, wherein the second absorbent material 156 soaked with the second disinfectant 157 or antimicrobial in the second cup 150 contacts the male Luer connector, the female Luer connector, and the hemodialysis connector after inserting the NFC connector into the second cup 150. As in current practice, the clinician then infuses the medication 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 disinfectant wipe or scrubbing device. The clinician then uses a locking syringe filled with heparin flush to then "lock" the IV line to help prevent blood clots from forming in the catheter. Finally, a new disinfection cap is attached to the resident catheter hub.

[0129] In current practice, clinicians only have one scrub device attached to the flush syringe, and the integrated scrub device is used before flushing. However, after the primary flush, a second scrub device attached to the syringe is not required to disinfect the catheter hub. Embodiments of the present disclosure provide an additional scrub device based on a flush syringe, such as a flush syringe with two disinfecting / scrubbing devices, which allows the clinician to disinfect the hub before and after flushing, thereby complying with SASH because the clinician does not need to find a disinfecting device or skip the connector disinfection before starting the next procedure (e.g., drug administration).

[0130] As mentioned above, currently available products and SASH practices do not address any cleaning after the initial flushing process, as disinfection is complete after the first flush. A benefit of an embodiment of the present invention including two separately bagged first and second cups 140, 150, each having an absorbent material (146, 156) loaded with disinfectant, is a two-step disinfection regime that additionally protects the patient by including an additional cleaning step of using IPA or a scrubber to disinfect the hub or connection interface prior to infusion of the drug or aspirated solution, thereby further preventing potential infection of the patient.

[0131] When the first cup 140 is used, once connected to the female or male Luer connector, compressing the first absorbent material 146 toward the closed end 142 of the chamber 145 allows the connector to contact the first disinfectant 147, thereby disinfecting the female or male Luer connector. Similarly, when the second cup 150 is used, once connected to the female or male Luer connector, compressing the second absorbent material 156 toward the closed end 152 of the second chamber 155 allows the connector to contact the second disinfectant 157, thereby disinfecting the female or male Luer connector.

[0132] In one or more embodiments, an assembly includes a device according to one or more embodiments connected to a medical connector. In one or more embodiments, the medical connector is selected from a male Luer connector, a female Luer connector, and a needle-free connector.

[0133] refer to Figure 7-12 , according to an exemplary embodiment of the present disclosure, a disinfection assembly 200 for connecting to a medical connector also generally includes a syringe assembly 210 having a syringe barrel 211 having an elongated body 212 to define a chamber 213 for holding a fluid. The syringe barrel 211 includes an open proximal end 214 having a flange 215 and a distal end 216 including a tip 217 having a passage 218 therein for communicating with the chamber fluid. The distal end 216 of the barrel also includes a locking Luer-type collar 219 concentrically surrounding the tip 217. The locking Luer-type collar 219 has an internal thread 220. The syringe assembly 210 further includes a stopper 221 connected to an elongated plunger rod 222, a scrubbing device 230 having a first cup 240 and a second cup 250, the elongated plunger rod 222 having a thumb press 223 at its proximal end. The bottom wall 231 spans the first cup 240.

[0134] refer to Figure 7 The first cup 240 includes an integral body 241, a closed end 242, and a central portion 244 extending from the closed end 242 to the open end 244 having a length L CThe first cup 240 has an annular wall 243 and a first peelable seal 248 having a top web 249, the annular wall 143 defining a chamber 245 for containing a first absorbent material 246 and a first disinfectant 247 in the first cup 240. The peelable seal 248 has a bottom surface 248B and a top surface 248T. The first absorbent material 246 is soaked in the first disinfectant 247 or antimicrobial agent. The open end 244 defines a bonding surface that contacts the bottom surface 248B of the peelable seal 248.

[0135] refer to Fig. 9 The second cup 250 includes an integral body 251, a closed end 252, and a body 254 extending from the closed end 252 to the open end 254 with a length L C The annular wall 253 defines a chamber 255 that contains a second absorbent material 256 and a second disinfectant 257 in the second cup 250. The second absorbent material 256 is soaked in the second disinfectant 257 or antimicrobial agent. The open end 254 defines an engagement surface that contacts the top surface 248T of the peelable seal 248. Fig. 9 The annular wall 253 of the second cup 250 includes an outer wall surface 253E and an inner wall surface 253I. The inner wall surface 253I defines an opening adjacent to the open end 254.

[0136] The first cup 240 and the second cup 250 are arranged in an up-and-down orientation, and the first cup 240 and the second cup 250 are defined or limited by a common peelable seal 248, wherein the open end 244 of the first cup 240 defines a bonding surface that contacts the bottom surface 248B of the peelable seal 248, and the open end 254 of the second cup 250 defines a bonding surface that contacts the top surface 248T of the peelable seal 248.

[0137] like Figure 7-12 As shown, the syringe assembly 210 can be attached to the first cup 240 of the scrubbing device 230 by a mechanical mating feature. Once assembled together, the assembly formed by the syringe assembly 210 and the first cup 240 of the scrubbing device 230 can withstand, for example, axial forces, radial forces, and disassembly forces. In order to remove the first cup 240 of the scrubbing device 230 from the syringe barrel, the user needs to apply torque to the entire assembly, thereby unscrewing the scrubbing device 230 from the locking Luer-type collar 219 at the distal end of the barrel to allow the flushing syringe to be attached to the IV catheter line. When torque is applied to either or both of the syringe or the first cup 240 of the scrubbing device 230, the scrubbing device 230 will be unscrewed from the barrel.

[0138] exist Figure 7-12In one or more embodiments shown in the drawings, the mechanical mating and assembly features ensure that the device can be assembled in an automated process and ensure the integrity of the device during transportation, use, and the entire service life of the product. The assembly of the scrubbing device 230 and the collar of the syringe, which is realized via a mechanical connection or a threaded connection, facilitates rapid automated assembly.

[0139] Compared to existing separate flush syringe and disinfection unit products, the integrated disinfection unit 200 embodiments of the present disclosure provide easier access to disinfection products at each flush and easier manual operation during disinfection prior to flushing.

[0140] In one or more embodiments, the disinfection unit 200 includes a connecting element to allow it to be connected to a syringe. In one or more embodiments, the connecting element is a threaded connection, such as a Luer threaded connection, to allow the assembled disinfection unit 200 to be connected to a syringe. In an exemplary embodiment of an embodiment of the present disclosure, the disinfection unit 200 includes integrated threads or tabs and other features that arbitrarily and in all combinations allow the first cup 240 to interface with a threaded fitting of a medical device. In one or more embodiments, the syringe assembly 210 can be attached to the first cup 240 of the scrubbing device 230 by using a variety of methods, including but not limited to mechanical fasteners, snap fits, and threaded connections. In one or more embodiments, the threaded connection is arranged on the bottom outer surface of the disinfection unit 200 and has threads sized and pitched to engage the threads of the Luer lock collar on the distal end of the syringe barrel to allow the assembled disinfection element 200 to be connected to a syringe. In Figure 9-11 In one or more embodiments shown in , the bottom wall 230 of the first cup 240 of the scrubbing device 230 includes a threaded post 232 disposed at the center of the bottom wall 231 of the first cup 240 that corresponds to the internal threads 220 of the locking Luer-type collar 219 on the distal end of the syringe barrel 211.

[0141] When used on a needleless connector ("NFC"), the scrubbing device 230 can achieve disinfection by integrating the first disinfectant 247 in the first absorbent material 246 disposed and contained in the first chamber 245 of the first cup 240, and integrating the second disinfectant 257 in the second absorbent material 256 disposed and contained in the second chamber 255 of the second cup 50. The first and second disinfectants (247, 257) can be directly included in the first chamber 245 and the second chamber 255, and can be absorbed into the first absorbent material 246 and the second absorbent material 256 (e.g., sponge or foam material) filling the chambers of the first cup 240 and the second cup 250, respectively. The scrubbing device 230 is designed to be compatible in interaction with various disinfectants. In one or more embodiments, the first disinfectant 247 or the second disinfectant 257 can include a variant of alcohol or chlorhexidine. In one or more embodiments, the first disinfectant 247 or the second disinfectant 257 is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylhydroxyanisole (BHA), butylhydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate diacetate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexidine, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, octenylamine, antibiotics, and mixtures thereof. In a specific embodiment, the first disinfectant 247 or the second disinfectant 257 includes at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, in one or more embodiments, the first disinfectant 247 or the second disinfectant 257 is a fluid or a gel.

[0142] The first absorbent material 246 absorbs the first disinfectant 247 or antimicrobial agent contained within the chamber 245 of the first cup 240. In one or more embodiments, the first absorbent material 246 is a nonwoven material, a foam, or a sponge. In a particular embodiment, the foam is a polyurethane foam. In a particular embodiment, the second absorbent material 256 is in the form of a foam plug. In one or more embodiments, the second absorbent material 256 includes one or more slits, such as Fig. 9 and Fig.11 shown.

[0143] A peelable seal 248 having a top web 249 is disposed on the engagement surface of the cup 240 to prevent the first absorbent material 246 from leaving the chamber 245. With the first absorbent material 246 properly inserted into the chamber 245 of the first cup 240, the peelable seal 248 can be secured to the engagement surface of the open end 244 of the first cup 240 to seal the scrubbing device 230.

[0144] The second absorbent material 256 is disposed and contained in the second chamber 255 of the second cup 250 and absorbs the second disinfectant 257 or antimicrobial agent contained in the second chamber 255 of the second cup 250. In one or more embodiments, the second absorbent material 256 is a nonwoven material, foam, or sponge. In a specific embodiment, the foam is a polyurethane foam. In a specific embodiment, the second absorbent material 256 is in the form of a foam plug. In one or more embodiments, the second absorbent material 256 includes one or more slits, such as Fig.11 and Fig.12 shown.

[0145] The peelable seal 248 minimizes the ingress of potentially hazardous particles and provides a substantially impermeable enclosure for the scrubbing device 230, provides a leakproof and protective enclosure, protects the contents of the first absorbent material 246 and the second absorbent material 256 contained within the first chamber 245 and the second chamber 255, respectively, and / or maintains a sealed, sterile environment. The peelable seal 248 provides an adequate seal over a range of temperature, pressure, and humidity levels. Referring to FIG. __, the peelable seal 248 is disposed on the open ends (244, 254) of the first cup 240 and the second cup 250 to prevent the pre-filled first and second disinfectants (247, 257) from exiting the respective chambers of the first cup 240 and the second cup 250.

[0146] The peelable seal 248 can be aluminum sealed with plastic and can be chemically resistant, lightproof, non-permeable or sterile. In one or more embodiments, the peelable seal 248 includes aluminum or a multi-layer polymer film peelable top layer. In a specific embodiment, the peelable seal 248 is heat sealed or induction sealed to the engaging surface of the open end (244, 254) of the cup (240, 250) to seal the scrubbing device 230. In one or more embodiments, the peelable seal 248 includes a moisture barrier.

[0147] The first and second absorbent materials 246, 256 and the disinfectant or antimicrobial agent contact the male Luer connector, the female Luer connector, and the hemodialysis connector after the connectors are inserted into the open ends (244, 254) of the respective cups 240 and 250.

[0148] In one or more embodiments, the female connector can be selected from the group consisting of a needleless connector, a catheter Luer connector, a stopcock, and a hemodialysis connector. In one or more embodiments, the male connector can be an intravenous tube end, a stopcock, or a male locking Luer.

[0149] The first cup 240 and the second cup 250 are made of any type of plastic material such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactic acid, acrylonitrile-butadiene-styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the first cup 240 and the second cup 250 include polypropylene or polyethylene materials.

[0150] In order to avoid having to use different types of disinfection caps to clean different types of connectors, the disinfection device 200 having the first cup 240 and the second cup 250 is compatible and engages with both the male and female Luer connectors, thereby allowing the user to clean different types of connectors with a single device. When the first cup 240 and the second cup 250 are mounted on the female or male Luer connector, the female or male medical connector engages the inner wall when inserted into the chamber 245 or 255, and contacts the first absorbent material 246 and enters the second absorbent material 256 soaked with a disinfectant or antimicrobial agent. Therefore, the device of the present disclosure can disinfect both the male and female Luer connectors, thereby meeting the current needs in the art.

[0151] Other aspects of the present disclosure relate to methods of sterilizing medical connectors and assemblies. In one or more embodiments, a method of sterilizing a medical connector includes connecting a device of one or more embodiments to the medical connector, wherein the connection includes frictionally engaging an inner wall surface when inserted into a cavity so that the medical connector contacts an absorbent material and a disinfectant or antimicrobial agent.

[0152] In use, the clinician peels the second cup 250 from the top web 249 of the peelable seal 248 to remove the second cup from the scrubbing device 230 in a manner that the peelable seal 248 remains on the first cup 240. The adhesive strength of the peelable seal 248 to the first cup 240 is greater than the adhesive strength of the peelable seal 248 to the second cup 250, thereby allowing the second cup to be removed from the scrubbing device 230 while allowing the peelable seal 248 to remain on the first cup 240. The clinician then uses the second cup 250 to disinfect the NFC. When the NFC 900 is inserted into the second cup 250, the second absorbent material 256 soaked with the second disinfectant 257 contacts the NFC. In one or more embodiments, the NFC 900 can be a male Luer connector, a female Luer connector, or a hemodialysis connector. Next, the clinician removes the first cup 240 of the scrubbing device 230 from the syringe barrel by applying torque on the entire assembly, thereby unscrewing the scrubbing device 230 from the locking Luer-type collar 219 at the distal end of the barrel 211 to allow the flushing syringe to be attached to the IV catheter line to flush the IV line. The clinician places the first cup 240 on a sterile tray for subsequent use of the first cup and engages the threads of the Luer lock collar on the distal end of the syringe barrel to the NFC to connect the NFC to the flushing syringe. The clinician then proceeds to flush the IV line. Next, the clinician picks up the separated first cup 240 of the scrubbing device 230, and after flushing the IV line, peels off the top web 259 from the first cup 240 to expose the first absorbent material 246 soaked in the first disinfectant 47, and uses the first cup 240 to disinfect the NFC, wherein the first absorbent material 246 soaked in the first disinfectant 247 or antimicrobial agent in the first cup 240 contacts the male Luer connector, the female Luer connector, and the hemodialysis connector after the NFC connector is inserted into the first cup 240. In practice, the clinician then administers medication and flushes the IV line a second time using a flushing syringe to remove any medication remaining in the catheter, and scrubs the hub using a disinfecting wipe or scrubbing device. The clinician then uses a locking syringe filled with heparin flushing fluid to "lock" the IV line to help prevent thrombosis in the catheter. Finally, a new disinfection cap is attached to the resident catheter hub.

[0153] As discussed above, current products and SASH practices do not address any cleaning after the initial flushing process, as disinfection is complete after the first flush. A benefit of an embodiment of the present invention that includes two separately packaged first and second cups 240, 250, both having an absorbent material loaded with a disinfectant, is a two-step disinfection mechanism that further protects the patient from potential infection by including an additional cleaning step of the hub or connection interface using IPA or a scrubber prior to drug or lock solution infusion.

[0154] When the first cup 240 is used, when connected to the female or male Luer connector, compression of the first absorbent material 246 toward the closed end 242 of the chamber 245 allows the connector to contact the first disinfectant 247 to disinfect the female or male Luer connector. Similarly, when the second cup 250 is used, when connected to the female or male Luer connector, compression of the second absorbent material 256 toward the closed end 252 of the second chamber 255 allows the connector to contact the second disinfectant 257 to disinfect the female or male Luer connector.

[0155] In one or more embodiments, an assembly includes a device connected to one or more embodiments of a medical connector. In one or more embodiments, the medical connector is selected from a male Luer connector, a female Luer connector, and a needle-free connector.

[0156] Reference Figure 13-Figure 18 , a disinfection unit 300 for connecting to a medical connector according to an exemplary embodiment of the present disclosure generally also includes a syringe assembly 310 having a syringe barrel 311 having an elongated body 312 defining a chamber 313 for holding a fluid. The syringe barrel 311 includes an open proximal end 314 having a flange 315 and a distal end 316 including a tip 317 having a passage 318 passing therethrough in fluid communication with the chamber. The distal end 316 of the barrel also includes a locking Luer-type collar 319 concentrically surrounding the tip 317. The locking Luer-type collar 319 has an internal thread 320. The syringe assembly 310 also includes a stopper 321 connected to an elongated plunger rod 322 and a scrubbing device 330 having a first cup 340 and a second cup 350, the elongated plunger rod 322 having a thumb press 323 located at its proximal end. The bottom wall 331 spans the first cup 340.

[0157] Reference Figure 15-17 The first cup 340 includes a unitary body 341, a closed end 342, and a length L extending from the closed end 342 to an open end 344 defining a first chamber. C The first chamber comprises a first absorbent material 346 and a first disinfectant 347 in the first cup 340. The peelable seal 348 has a bottom surface 348B and a top surface 348T. The first absorbent material 346 is soaked in the first disinfectant 347 or antimicrobial agent. The open end 344 defines a bonding surface to contact the bottom surface 348B of the first peelable seal 348.

[0158] Reference Figure 15-17The second cup 350 includes a unitary body 351, a closed end 352, and a length L extending from the closed end 352 to an open end 354 defining a second chamber 355. C The second chamber 355 includes a second absorbent material 356 and a second disinfectant 357 in the second cup 350. The second absorbent material 356 is soaked in the second disinfectant 357 or antimicrobial agent. The open end 354 defines a bonding surface to contact the top surface 358T of the second peelable seal 358.

[0159] The open end 344 of the first cup 340 defines an engagement surface to contact the bottom surface 348B of the first peelable seal 348, and the open end 354 of the second cup 350 defines an engagement surface to contact the top surface 358T of the second peelable seal 348. The first cup 340 and the second cup 350 are arranged in a top-bottom orientation, and the top surface of the first peel seal and the top surface of the second peel surface in the first cup 340 and the second cup 350 are bonded together using a low bond strength adhesive 360.

[0160] like Figure 16-Figure 18 As shown, the syringe assembly 310 can be attached to the first cup 340 of the scrubbing device 330 by mechanical mating features. Once assembled together, the components of the syringe assembly 310 and the first cup 340 of the scrubbing device 330 can withstand axial and radial disassembly forces. In order to remove the first cup 340 of the scrubbing device 330 from the syringe barrel, the user should apply torque on the entire assembly to unscrew the scrubbing device 330 from the locking Luer-type collar 319 at the distal end of the barrel to allow the flushing device to be attached to the IV catheter line. When torque is applied to the syringe or the first cup 340 of the scrubbing device 330, or both, the scrubbing device 330 should be unscrewed from the barrel.

[0161] exist Figure 16-Figure 18 In one or more of the embodiments shown, the mechanical fit and assembly features ensure that the device can be assembled in an automated process and ensure the integrity of the device during shipping, use, and during the shelf life of the product. The assembly of the wiping device 330 and the collar of the syringe via a mechanical connection or a threaded connection of the present disclosure facilitates high-speed, automated assembly.

[0162] Compared to currently available separate flush syringe and disinfection unit products, embodiments of the integrated disinfection unit 300 of the present disclosure provide easy access to disinfection product at each flush as well as easier manual operation during disinfection prior to flushing.

[0163] In one or more embodiments, the disinfection unit 300 includes a connection element that allows it to be connected to a syringe. In one or more embodiments, the connection element is a threaded connection, such as a Luer threaded connection, to allow the assembled disinfection unit 300 to be connected to a syringe. In an exemplary embodiment of an embodiment of the present disclosure, the disinfection unit 300 includes integrated threads or tabs, and other features that allow the first cup 340 to dock with any and all combinations of threaded fittings of a medical device. In one or more embodiments, the syringe assembly 310 can be attached to the first cup 340 of the scrubbing device 330 using various methods, including but not limited to mechanical fasteners, snap fits, and threaded connections. In one or more embodiments, the threaded connection is arranged on the bottom outer surface of the disinfection unit 300, and its thread size and pitch are set to engage the threads of the Luer lock collar on the distal end of the syringe barrel to allow the assembled disinfection unit 300 to be connected to a syringe. In an exemplary embodiment of an embodiment of the present disclosure, the disinfection unit 300 includes integrated threads or tabs, and other features that allow the first cup 340 to dock with the threaded fittings of the medical device. In one or more embodiments, the syringe assembly 310 can be attached to the first cup 340 of the scrubbing device 330 using various methods, including but not limited to mechanical fasteners, snap fits, and threaded connections. In one or more embodiments, the threaded connection is arranged on the bottom outer surface of the disinfection unit 300, and its thread size and pitch are set to engage the threads of the Luer lock collar on the distal end of the syringe barrel to allow the assembled disinfection unit 300 to be connected to a syringe. In an exemplary embodiment of the present disclosure, the disinfection unit 300 includes integrated threads or tabs, and other features that allow the first cup 340 to dock with the threaded fittings of the medical device. In an exemplary embodiment of the present disclosure, the disinfection unit 300 includes integrated threads or tabs, and other features that Fig.15 In one or more embodiments shown, the bottom wall 331 of the first cup 340 of the scrubbing device 330 includes a threaded post 332 disposed at the center of the bottom wall 331 of the first cup 340 that corresponds to the internal threads 320 of the locking Luer-type collar 319 on the distal end of the syringe barrel 311 .

[0164] When used on a needleless connector ("NFC"), the scrubbing device 330 can achieve disinfection by integrating a first disinfectant 347 in a first absorbent material 346 disposed and contained in a first chamber 345 of a first cup 340, and integrating a second disinfectant 357 in a second absorbent material 356 disposed and contained in a second chamber 355 of a second cup 350. The first and second disinfectants (347, 357) can be directly included in the first chamber 345 and the second chamber 355, and can be absorbed into the first absorbent material 346 and the second absorbent material 356 (e.g., sponge or foam material) that fill the chambers of the first cup 340 and the second cup 350, respectively. The scrubbing device 330 is designed to be compatible in interaction with various disinfectants. In one or more embodiments, the first disinfectant 347 or the second disinfectant 357 can include a variant of alcohol or chlorhexidine. In one or more embodiments, the first disinfectant 347 or the second disinfectant 357 is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylhydroxyanisole (BHA), butylhydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate diacetate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexidine, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, octenylamine, antibiotics, and mixtures thereof. In a specific embodiment, the first disinfectant 347 or the second disinfectant 357 includes at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the first disinfectant 347 or the second disinfectant 357 is a fluid or a gel.

[0165] The first absorbent material 346 absorbs the first disinfectant 347 or antimicrobial agent contained in the first chamber 345 of the first cup 340. In one or more embodiments, the first absorbent material 346 is a nonwoven material, a foam, or a sponge. In a particular embodiment, the foam is a polyurethane foam. In a particular embodiment, the second absorbent material 356 is in the form of a foam plug. In one or more embodiments, the second absorbent material 356 includes one or more slits, such as Fig.14 and Fig.15 shown.

[0166] A first peelable seal 348 having a top web 349 is disposed on the engagement surface of the first cup 340 to prevent the first absorbent material 346 from leaving the first chamber 345. With the first absorbent material 346 properly inserted into the first chamber 345 of the first cup 340, the first peelable seal 348 may be secured to the engagement surface of the open end 344 of the first cup 340 to seal the scrubbing device 330.

[0167] A second peelable seal 358 having a top web 359 is disposed on the engagement surface of the second cup 350 to prevent the second absorbent material 356 from leaving the second chamber 355. With the second absorbent material 356 properly inserted into the second chamber 355 of the second cup 350, the second peelable seal 358 can be secured to the engagement surface of the open end 354 of the second cup 350 to seal the scrubbing device 330.

[0168] The second absorbent material 356 is disposed and contained in the second chamber 355 of the second cup 350 and absorbs the second disinfectant 357 or antimicrobial agent contained in the second chamber 355 of the second cup 350. In one or more embodiments, the second absorbent material 356 is a nonwoven material, a foam, or a sponge. In a particular embodiment, the foam is a polyurethane foam. In a particular embodiment, the second absorbent material 356 is in the form of a foam plug. In one or more embodiments, the second absorbent material 356 includes one or more slits, such as Fig.14 and 15 shown.

[0169] The first peelable seal 348 and the second peelable seal 358 minimize the ingress of potentially hazardous particles and provide a substantially impermeable enclosure for the scrubbing device 330, provide a leakproof and protective enclosure, protect the contents of the first absorbent material 346 and the second absorbent material 356 contained in the first chamber 345 and the second chamber 355, respectively, and / or maintain a sealed, sterile environment. The first peelable seal 348 and the second peelable seal 358 provide an adequate seal under a range of temperature, pressure, and humidity levels. The first peelable seal 348 and the second peelable seal 358 can be disposed on the respective open ends (344, 354) of the first cup 340 and the second cup 350 to prevent the pre-filled first and second disinfectants (347, 357) from leaving the respective chambers of the first cup 240 and the chambers of the second cup 350.

[0170] The first peelable seal 348 and the second peelable seal 358 can be plastic sealed aluminum and can be chemically resistant, lightproof, non-permeable or sterile. In one or more embodiments, the first peelable seal 348 and the second peelable seal 358 include aluminum or a multi-layer polymer film peelable top layer. In a specific embodiment, the first peelable seal 348 and the second peelable seal 358 are heat sealed or induction sealed to the engaging surface of the open end (344, 354) of the cup (340, 350) to seal the scrubbing device 330. In one or more embodiments, the first peelable seal 348 and the second peelable seal 358 include a moisture barrier.

[0171] The first and second absorbent materials 346, 356 and the disinfectant or antimicrobial agent contact the male Luer connector, the female Luer connector, and the hemodialysis connector after the connectors are inserted into the open ends (344, 354) of the respective cups 340 and 350.

[0172] In one or more embodiments, the female connector can be selected from the group consisting of a needleless connector, a catheter Luer connector, a stopcock, and a hemodialysis connector. In one or more embodiments, the male connector can be an intravenous tube end, a stopcock, or a male locking Luer.

[0173] The first cup 340 and the second cup 350 are made of any type of plastic material such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactic acid, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the first cup 340 and the second cup 350 include polypropylene or polyethylene materials.

[0174] In order to avoid having to use different types of disinfection caps to clean different types of connectors, the disinfection device 300 having the first cup 340 and the second cup 350 is compatible and engages with both the male and female Luer connectors, thereby allowing the user to clean different types of connectors with a single device. When the first cup 340 and the second cup 350 are mounted on the female or male Luer connector, the female or male medical connector engages the inner wall when inserted into the first chamber 345 or the second chamber 355, and contacts the first absorbent material 346 and enters the second absorbent material 356 soaked with a disinfectant or antimicrobial agent. Therefore, the device of the present disclosure can disinfect both the male and female Luer connectors, thereby meeting the current needs in the art.

[0175] Other aspects of the present disclosure relate to methods of sterilizing medical connectors and assemblies. In one or more embodiments, a method of sterilizing a medical connector includes connecting a device of one or more embodiments to the medical connector, wherein the connection includes frictionally engaging an inner wall surface when inserted into a cavity so that the medical connector contacts an absorbent material and a disinfectant or antimicrobial agent.

[0176] In use, the clinician peels the second cup 350 from the first cup to remove the second cup from the scrubbing device 330 in a manner that allows the first peelable seal 348 to remain on the first cup 340 and the second peelable seal to remain on the second cup 350. The bonding strength of the first peelable seal 348 to the first cup 340 and the bonding strength of the second peelable seal 358 to the second cup 350 are greater than the bonding strength of the low bonding strength adhesive that bonds the top surface of the first peel seal to the top surface of the second peel surface, thereby allowing the second cup to be removed from the first cup 340 while allowing the first peelable seal 348 to remain on the first cup 340 and the second peelable seal 358 to remain on the second cup 350. The clinician places the second cup 350 on a sterile tray for subsequent use of the sealed second cup. The clinician peels the top web 349 of the first peelable seal 348 from the first cup 40. The clinician then uses the first cup 340 to sterilize the NFC before flushing the IV line. When the NFC is inserted into the first cup 340, the first absorbent material 346 soaked with the first disinfectant 347 contacts the NFC. Next, the clinician removes the first cup 340 of the scrubbing device 330 from the syringe barrel by applying torque to the entire assembly, thereby unscrewing the scrubbing device 330 from the locking Luer-type collar 319 at the distal end of the syringe barrel 311 to allow the flushing syringe to be attached to the IV catheter line to flush the IV line. When torque is applied to the syringe or the first cup 340, or both, the first cup 340 of the scrubbing device 330 should be screwed out of the barrel. The clinician then engages the threads of the Luer lock collar on the distal end of the syringe barrel to the NFC to connect the NFC to the flushing syringe. After flushing, the clinician picks up the separated second cup 350 of the scrubbing device 330 and peels off the top web 359 from the second cup 350 to expose the second absorbent material 356 soaked in the second disinfectant 357 after flushing the IV line, and uses the second cup 350 to disinfect the NFC by contacting the male Luer connector, the female Luer connector, and the hemodialysis connector after the NFC connector is inserted into the second cup 350 with the second absorbent material 356 soaked in the second disinfectant 357. In practice, the clinician then administers medication and flushes the IV line a second time using a flushing syringe to remove any medication remaining in the catheter and scrubs the hub using a disinfecting wipe or scrubbing device. The clinician then uses a locking syringe filled with heparin flushing solution to "lock" the IV line to help prevent thrombosis in the catheter. Finally, a new disinfection cap is attached to the resident catheter hub.

[0177] As discussed above, current products and SASH practices do not address any cleaning after the initial flushing process, as disinfection is complete after the first flush. A benefit of embodiments of the present invention including two separately packaged first and second cups 340, 350, both having absorbent material (346, 356) loaded with disinfectant, is a two-step disinfection mechanism that further protects the patient from potential infection by including an additional cleaning step of the hub or connection interface using IPA or a scrubber prior to drug or lock solution infusion.

[0178] When the first cup 340 is used, when connected to the female or male Luer connector, compression of the first absorbent material 346 toward the closed end 342 of the first chamber 345 allows the connector to contact the first disinfectant 347 to disinfect the female or male Luer connector. Similarly, when the second cup 350 is used, when connected to the female or male Luer connector, compression of the second absorbent material 356 toward the closed end 352 of the second chamber 355 allows the connector to contact the second disinfectant 357 to disinfect the female or male Luer connector.

[0179] In one or more embodiments, an assembly includes a device connected to one or more embodiments of a medical connector. In one or more embodiments, the medical connector is selected from a male Luer connector, a female Luer connector, and a needle-free connector.

[0180] refer to Figure 19-23 According to an exemplary embodiment of the present disclosure, a disinfection unit 400 for connecting to a medical connector generally also includes a syringe assembly 410 having a syringe barrel 411 having an elongated body 412 defining a chamber 413 for holding a fluid. The syringe barrel 411 includes an open proximal end 414 having a flange 415 and a distal end 416 including a tip 417 having a passage 418 passing therethrough in fluid communication with the chamber. The distal end 416 of the barrel also includes a locking Luer-type collar 419 concentrically surrounding the tip 417. The locking Luer-type collar 419 has an internal thread 420. The syringe assembly 410 also includes a stopper 421 connected to an elongated plunger rod 422 and a scrubbing device 430 having a first cup 440 and a second cup 450, the elongated plunger rod 422 having a thumb press 423 located at its proximal end. The bottom wall 431 spans the first cup 440.

[0181] refer to Fig. 22 The first cup 440 includes a unitary body 441, a closed end 442, and a length L extending from the closed end 442 to an open end 444 defining a first chamber 445 containing a first absorbent material 446 and a first disinfectant 447 in the first cup 440.C The first absorbent material 446 is soaked in a first disinfectant 447 or antimicrobial agent. The open end 444 defines an engagement surface to contact the bottom surface 448B of the first peelable seal 448.

[0182] The open end 444 of the first cup 440 defines an engagement surface that contacts a bottom surface 448B of the first peelable seal 448 , and the open end 454 of the second cup 450 defines an engagement surface that contacts a top surface 458T of the second peelable seal 458 .

[0183] like Fig.23 As shown, the syringe assembly 410 can be attached to the first cup 440 of the scrubbing device 430 by a mechanical mating feature. Once assembled together, the components of the syringe assembly 410 and the first cup 440 of the scrubbing device 430 are able to withstand axial and radial disassembly forces. In order to remove the first cup 440 of the scrubbing device 430 from the syringe barrel, the user should apply torque on the entire assembly to unscrew the scrubbing device 430 from the locking Luer-type collar 419 at the distal end of the barrel to allow the flushing syringe to be attached to the IV catheter line. When torque is applied to the syringe or the first cup 440 of the scrubbing device 430, or both, the scrubbing device 430 should be screwed out of the barrel.

[0184] refer to Fig. 22 The second cup 450 includes a unitary body 451, a closed end 452, and an open end 454 extending from the closed end 452 to define a second chamber 455 containing a second absorbent material 456, and has a length L C The second cup 450 includes an annular wall 453, a closed end 452 of the annular wall 453 having a boss extending from the closed end 454, a second disinfectant 457 in the second cup 450, and a second peelable seal 458 having a top web 459. The second absorbent material 456 is soaked in the second disinfectant 457 or antimicrobial agent. The open end 454 defines an engagement surface to contact the top surface 448T of the second peelable seal 458.

[0185] like Figure 20-23 As shown, the second cup and syringe assembly interlocks by an interference fit or snap fit between the thumb press of the syringe and the boss of the second cup. The boss / wedge may be arranged at the closed end of the annular wall of the second cup to provide a snap connection with the thumb press. The inner surface of the top wall disposed at the closed end of the annular wall of the second cup may have a groove into which the boss / wedge of the insert may be inserted.

[0186] exist Figure 20-23In one or more of the embodiments shown, the mechanical fit and assembly features ensure that the device can be assembled in an automated process and ensure the integrity of the device during shipping, use, and during the shelf life of the product. The assembly of the wiping device 430 and the collar of the syringe via a mechanical connection or a threaded connection of the present disclosure facilitates high-speed, automated assembly.

[0187] Compared to currently available separate flush syringe and disinfection unit products, embodiments of the integrated disinfection unit 400 of the present disclosure provide easy access to disinfection product at each flush as well as easier manual operation during disinfection prior to flushing.

[0188] In one or more embodiments, the disinfection unit 400 includes a connection element that allows it to be connected to a syringe. In one or more embodiments, the connection element is a threaded connection, such as a Luer threaded connection, to allow the assembled disinfection unit 400 to be connected to a syringe. In an exemplary embodiment of an embodiment of the present disclosure, the disinfection unit 400 includes integrated threads or tabs, and other features that allow the first cup 440 to dock with any and all combinations of threaded fittings of a medical device. In one or more embodiments, the syringe assembly 410 can be attached to the first cup 440 of the scrubbing device 430 using various methods, including but not limited to mechanical fasteners, snap fits, and threaded connections. In one or more embodiments, the threaded connection is arranged on the bottom outer surface of the first cup of the disinfection unit 400, and its thread size and pitch are set to engage the threads of the Luer lock collar on the distal end of the syringe barrel to allow the assembled disinfection unit 400 to be connected to a syringe. In such Fig.21 In one or more embodiments shown, the bottom wall 431 of the first cup 440 of the scrubbing device 430 includes a threaded post 432 disposed at the center of the bottom wall 431 of the first cup 440 that corresponds to the internal threads 420 of the locking Luer-type collar 419 on the distal end of the syringe barrel 411. Fig.23 As shown, the second cup and syringe assembly are interlocked by the thumb pressure of the syringe and the interference fit or snap fit of the boss of the second cup. The boss / wedge can be arranged at the closed end of the annular wall of the second cup to provide a snap connection with the thumb pressure portion. The inner surface of the top wall disposed at the closed end of the annular wall of the second cup can have a groove into which the peripheral boss 460 of the insert can be inserted.

[0189] The closed end defines an end face that includes a peripheral boss 460 extending radially outwardly from the annular wall.

[0190] The second cup is adapted to snap fit over the thumb press portion of the plunger rod, opposite the Luer tip. Fig.23In one or more embodiments, the second cup can be connected to the thumb press portion, wherein the rim is disposed on the peripheral boss and radially inward to create a lip or rim. The inner surface of the peripheral boss in the inner annular wall surface of the second cup at the closed end includes at least two or more mating protrusions 470, which allow the thumb press portion to be mated with the second cup via a snap-fit ​​connection. In one or more embodiments, the snap-fit ​​connection includes a protruding rim and a snap area. The protruding rim can be disposed on the inner surface of the peripheral side wall of the peripheral boss at the closed end or on the inner annular wall surface of the second cup, and the corresponding snap area is disposed on the surface opposite to the protruding rim to allow the protruding rim and the snap area to interlock.

[0191] In one or more embodiments, mechanical locking is achieved by using protrusions, ribs, undercuts, interference fits, and locking tapers. In certain embodiments of the integrated second cup 450 with a thumb press of the present disclosure, the second cup 450 has a locking tab 470 on the inner annular wall surface at the closed end, which is annular and structurally stronger and easier to mold.

[0192] In one or more embodiments, the clip is configured as a locking mechanism whereby the one-way flexing clip requires relatively low axial force to assemble and produces significant locking strength. As the second cup and thumb press are assembled, the clips flex inwardly until they enter the thumb press of the plunger rod. Once contact is made between the clip and the thumb press, the clips spring or deflect outwardly, thereby creating a mating fit between the thumb press and the second cup 450.

[0193] Specifically, during assembly of the second cup 450 and the thumb press 423, the closed end of the second cup 450 is inserted into the thumb press 423. The clip bends inwardly toward the annular wall of the second cup 450. Once the clip moves past and over the thumb press 423, the clip pops outward, thereby creating a permanent fit between the two parts without the use of adhesive. Once assembly is complete, the mechanical fit prevents the second cup 450 from being removed from the thumb press 423 by pulling the parts away from each other.

[0194] As the second cup and the thumb press are assembled, the bottom end of the cup is oriented to face the top end of the thumb press. During assembly, the second cup is pressed onto the thumb press, and the peripheral edge causes the protrusions on the inner annular wall surface at the closed end of the second cup 450 to radiate outward. Once the protrusions of the cup pass over the peripheral edge of the thumb press, the protrusions will rebound inward and lock the cup onto the thumb press.

[0195] The second cup may also include a skirt extending away from the closed end of the second cup 450. The skirt includes a lip on the side wall of the skirt facing the x-axis of the second cup. Generally, as the cup and thumb press are assembled, the outer skirt of the second cup bends outward until they engage the beveled edge on the outer wall surface on the thumb press. Once the lip passes over the beveled edge, the outer skirt springs inward, thereby creating a lock between the thumb press and the second cup.

[0196] When used on a needleless connector ("NFC"), the scrubbing device 430 can achieve disinfection by integrating a first disinfectant 447 in a first absorbent material 446 disposed and contained in a first chamber 445 of a first cup 440 and integrating a second disinfectant 447 in a second absorbent material 456 disposed and contained in a second chamber 455 of a second cup 450. The first and second disinfectants (447, 457) can be directly contained in the first chamber 445 and the second chamber 455, and can be absorbed into the first absorbent material 446 and into the second absorbent material 456 (e.g., a sponge or foam material) that fill the chambers of the first cup 440 and the second cup 450, respectively. The scrubbing device 430 is designed to interact with a variety of disinfectants. In one or more embodiments, the first disinfectant 447 or the second disinfectant 457 can include a variant of alcohol or chlorhexidine. In one or more embodiments, the first disinfectant 447 or the second disinfectant 457 is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylhydroxyanisole (BHA), butylhydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate diacetate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexidine, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, octenylamine, antibiotics, and mixtures thereof. In a specific embodiment, the first disinfectant 447 or the second disinfectant 457 includes at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the first disinfectant 447 or the second disinfectant 457 is a fluid or a gel.

[0197] The first absorbent material 446 absorbs the first disinfectant 447 contained in the first chamber 445 of the first cup 440. In one or more embodiments, the first absorbent material 446 is a nonwoven material, a foam, or a sponge. In a specific embodiment, the foam is a polyurethane foam. In a specific embodiment, the second absorbent material 456 is in the form of a foam plug. In one or more embodiments, the second absorbent material 456 includes one or more slits, such as Fig.21 and Fig.23 shown.

[0198] A first peelable seal 448 having a top web 449 is disposed on the engagement surface of the first cup 440 to prevent the first absorbent material 446 from leaving the first chamber 445. With the first absorbent material 446 properly inserted into the first chamber 445 of the first cup 440, the first peelable seal 448 can be secured to the engagement surface of the open end 444 of the first cup 440 to seal the scrubbing device 430.

[0199] A second peelable seal 458 having a top web 459 is disposed on the engagement surface of the second cup 450 to prevent the second absorbent material 456 from leaving the second chamber 455. With the second absorbent material 456 properly inserted into the second chamber 455 of the second cup 450, the second peelable seal 458 can be secured to the engagement surface of the open end 454 of the second cup 450 to seal the scrubbing device 430.

[0200] The second absorbent material 456 is placed and contained in the second chamber 455 of the second cup 450, and absorbs the second disinfectant 457 contained in the second chamber 455 of the second cup 450. In one or more embodiments, the absorbent material 456 is a non-woven material, foam or sponge. In a specific embodiment, the foam is polyurethane foam. In a specific embodiment, the second absorbent material 456 is in the form of a foam plug. In one or more embodiments, the second absorbent material 456 includes one or more slits, such as Fig.21 and Fig.23 shown.

[0201] The first peelable seal 448 and the second peelable seal 458 minimize the danger of potential particle ingress and also provide a substantially impermeable enclosure for the scrubbing device 430, provide a leakproof and protective enclosure, protect the contents of the first absorbent material 446 and the second absorbent material 456 contained in the first chamber 445 and the second chamber 455, respectively, and / or maintain a sealed, sterile environment. The first peelable seal 448 and the second peelable seal 458 provide an adequate seal under a range of temperature, pressure, and humidity levels. The first peelable seal 448 and the second peelable seal 458 can be disposed on the respective open ends (444, 454) of the first cup 440 and the second cup 450 to prevent the pre-filled first and second disinfectants (447, 457) from leaving the chambers of the respective first cup 440 and the second cup 450.

[0202] The first peelable seal 448 and the second peelable seal 458 can be plastic sealed aluminum and can be chemical resistant, light blocking, impermeable or sterile. In one or more embodiments, the first peelable seal 448 and the second peelable seal 458 can include aluminum or a multi-layer polymer film peelable top layer. In a specific embodiment, the first peelable seal 448 and the second peelable seal 458 are heat sealed or induction sealed to the engaging surface of the open end (444, 454) of the cup (440, 450) to seal the scrubbing device 430. In one or more embodiments, the first peelable seal 448 and the second peelable seal 458 include a moisture barrier.

[0203] The first and second absorbent materials 446, 456 and the disinfectant contact the male Luer connector, the female Luer connector, and the hemodialysis connector after the connectors are inserted into the open ends (444, 454) of the respective cups 440 and 450.

[0204] In one or more embodiments, the female connector can be selected from the group consisting of a needleless connector, a catheter Luer connector, a stopcock, and a hemodialysis connector. In one or more embodiments, the male connector can be an intravenous tubing end, a stopcock, or a male locking Luer connector.

[0205] The first cup 440 and the second cup 450 are made of any type of plastic material, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactic acid, acrylonitrile-butadiene-styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the first cup 440 and the second cup 450 include polypropylene or polyethylene materials.

[0206] In order to avoid having to use different types of disinfection caps to clean different types of connectors, the disinfection device 400 having the first cup 440 and the second cup 450 is compatible and engageable with the male Luer connector and the female Luer connector, thereby allowing the user to use a single device to clean different types of connectors. After the first cup 440 and the second cup 450 are mounted on the female Luer connector or the male Luer connector, the female or male medical connector engages the inner wall after being inserted into the chamber 445 or 455 and contacts the first absorbent material 446 and the second absorbent material 456 soaked with disinfectant. Therefore, the device of the present disclosure can disinfect both the male Luer connector and the female Luer connector, thereby meeting the current needs in the art.

[0207] Other aspects of the present disclosure relate to methods of sterilizing medical connectors and assemblies. In one or more embodiments, a method of sterilizing a medical connector includes connecting a device of one or more embodiments to the medical connector, wherein the connection includes frictionally engaging an inner wall surface after insertion into a cavity so that the medical connector contacts an absorbent material and a sterilant.

[0208] In use, the clinician breaks off and removes the second cup from the syringe assembly, and the clinician places the second cup 450 on a sterile tray to subsequently sterilize the NFC using the sealed second cup before flushing. As described above, the snap feature in the underside of the second cup is separated from the thumb-pressing portion of the plunger of the syringe. The clinician peels off the top web 449 of the first peelable seal 448 from the first cup 40. The clinician then uses the first cup 440 to sterilize the NFC before flushing the IV line. After the NFC is inserted into the first cup 440, the first absorbent material 446 soaked with the disinfectant 447 contacts the NFC. Next, the clinician unscrews the scrubbing device 430 from the locking Luer-type collar 419 at the distal end of the syringe barrel 411 by applying torque to the entire assembly, thereby removing the first cup 440 of the scrubbing device 430 from the syringe barrel to allow the flushing syringe to be attached to the IV catheter line to flush the IV line. When torque is applied to the syringe or the first cup 440 or both, the first cup 440 of the scrubbing device 430 should be unscrewed from the barrel. The clinician then engages the threads of the Luer lock collar on the distal end of the syringe barrel to the NFC to connect the NFC to the flushing syringe. After flushing, the clinician picks up the disassembled second cup 450 of the scrubbing device 430 and peels off the top web 459 from the second cup 450 after flushing the IV line to expose the second absorbent material 456 soaked in the second disinfectant 457 and disinfects the NFC by contacting the male Luer connector, the female Luer connector, and the hemodialysis connector using the second cup 450 after inserting the NFC connector into the second cup 450 with the second absorbent material 456 soaked in the second disinfectant 457. As in current practice, the clinician then administers medication and performs a second flush of the IV line using the flushing syringe to remove any medication remaining in your catheter and scrubs the hub using a disinfecting wipe or scrubbing device. The clinician then "locks" the IV line using a locking syringe filled with heparin flush to help prevent blood clots from forming in the catheter. Finally, a new sterile cap is attached to the resident catheter hub.

[0209] As discussed above, current products and SASH practices do not address any cleaning after the initial flushing process, as disinfection ends after the first flush. An advantage of embodiments of the present invention including two separately packaged first and second cups 440, 450, each having an absorbent material (446, 456) loaded with disinfectant, is a two-step disinfection mechanism that provides additional protection for the patient by including an additional cleaning step of disinfecting the hub or connection interface using IPA or a scrubbing device prior to drug or lock solution infusion, thereby further preventing potential infection to the patient.

[0210] When the first cup 440 is used, after being connected to the female or male Luer connector, compression of the first absorbent material 446 toward the closed end 442 of the first chamber 445 allows the connector to contact the first disinfectant 447 to disinfect the female or male Luer connector. Similarly, when the second cup 450 is used, after being connected to the female or male Luer connector, compression of the second absorbent material 456 toward the closed end 452 of the second chamber 455 allows the connector to contact the second disinfectant 457 to disinfect the female or male Luer connector.

[0211] In one or more embodiments, an assembly includes a device connected to one or more embodiments of a medical connector. In one or more embodiments, the medical connector is selected from a male Luer connector, a female Luer connector, and a needle-free connector.

[0212] In another alternative embodiment, reference Figure 24-Figure 29 , a disinfection unit 500 for connecting to a medical connector includes a syringe assembly 510 having a syringe barrel 511 having an elongated body 512 defining a chamber 513 for retaining a fluid. The syringe barrel 511 includes an open proximal end 514 having a flange 515 and a distal end 516 including a tip 517 having a passage 518 passing therethrough in communication with the chamber fluid. The distal end 516 of the barrel also includes a locking Luer-type collar 519 concentrically surrounding the tip 517. The locking Luer-type collar 519 has an internal thread 520. The syringe assembly 510 also includes a stopper 521 connected to an elongated plunger rod 522 having a thumb press 523 at its proximal end.

[0213] Reference Figure 24-Figure 29 The disinfection unit 500 for connecting to a medical connector according to an exemplary embodiment of the present disclosure generally further includes a scrubbing device 530 having a first cup 540 and a second cup 550. A bottom wall 531 spans the first cup 540 and the second cup 550.

[0214] Reference Figure 24-Figure 29The first cup 540 includes an integral body 541, a closed end 542, an annular wall 543 and a first peelable seal 548, wherein the annular wall 543 has a length L extending from the closed end 542 to the open end 544. C , defining a first chamber containing a first absorbent material 546 and a first disinfectant 547 in the first cup 540. The first absorbent material 546 is soaked in the first disinfectant 547. The open end 544 defines an engagement surface to contact a first peelable seal 548 having a top web 549.

[0215] Reference Figure 24-Figure 29 The second cup 550 includes a unitary body 551, a closed end 552, an annular wall 553, and a second peelable seal 558 having a top web 559, wherein the annular wall 553 has a length L extending from the closed end 552 to the open end 554. C , defining a chamber 555 for containing a second absorbent material 556 and a second disinfectant 557 in the second cup 550. The second absorbent material 556 is soaked in the second disinfectant 557. The open end 554 defines an engagement surface to contact a second peelable seal 558.

[0216] The first cup 540 and the second cup 550 are arranged in a side-by-side orientation, and the first cup 540 and the second cup 550 are defined by a female T-slot 570 feature on the first cup 540 that engages with a male T-nut fastener 580 on the second cup 550. In an alternative embodiment, the first cup 540 and the second cup 550 are defined by a female T-slot 570 feature on the second cup 550 that engages with a male T-nut fastener 580 on the first cup 540. The detents on the T-slot and the T-nut fastener provide a mechanical lock between the two components. Once the T-slot can be installed with a corresponding T-nut fastener having an oval shoulder, the oval shoulder aligns within the upper portion of the T-slot and locks into the T-slot with a secure connection when rotated 90°. In order to remove the first cup 540 from the syringe barrel, the user should apply an axial force to the bottom of the first cup in an upward direction toward the user, or grasp and pull the top portion of the first cup toward the user, or both, to disengage the first cup of the scrubbing device 530 from the second cup of the scrubbing device 530. To remove the second cup of the scrubber 530 from the syringe barrel, the user should apply torque to the entire assembly, thereby unscrewing the scrubber 530 from the locking Luer-type collar 519 at the distal end of the barrel to allow the flush syringe to be attached to the IV catheter line. When torque is applied to the syringe or the scrubber 530, or both, the scrubber 530 should unscrew from the barrel.

[0217] like Figure 26-Figure 29As shown, the syringe assembly 510 can be attached to the scrubber 330 with mechanical mating features. Once assembled together, the assembly of the syringe assembly 510 and the scrubber 530 can withstand axial, radial, and removal forces. In order to remove the scrubber 530 from the syringe barrel, the user should apply torque on the entire assembly to unscrew the scrubber 530 from the locking Luer-type collar 519 at the distal end of the barrel to allow the flushing syringe to be attached to the IV catheter line. When torque is applied to the syringe or the scrubber 530 or both, the scrubber 530 should be unscrewed from the barrel.

[0218] In the prior art, a "bracket" underside is used to hold the disinfection unit, resulting in the bracket being easily disassembled by the user during normal use. The assembly of the scrubbing device 530 and the collar of the syringe of the present disclosure does not require a separate "bracket" or other device to assemble the devices together.

[0219] In such Figure 26-Figure 29 In one or more of the embodiments shown, mechanical mating and assembly features ensure that the device can be assembled in an automated process and ensure the integrity of the device during shipping, use, and product shelf life. The assembly of the wiping device 530 and the collar of the syringe via a mechanical connection or a threaded connection of the present disclosure facilitates high-speed, automated assembly.

[0220] Compared to currently available separate flush syringe and disinfection unit products, embodiments of the integrated disinfection unit of the present disclosure provide for easy access to disinfection product at each flush and easier manual operation during disinfection followed by flushing.

[0221] In one or more embodiments, Figure 26-Figure 29 As shown. The disinfection unit 500 includes a connecting element that allows it to be connected to a syringe. In one or more embodiments, the connecting element is a threaded connector, such as a Luer thread connector, to allow the assembled disinfection unit 500 to be connected to a syringe. In an exemplary embodiment of an embodiment of the present disclosure, the disinfection unit 500 includes integrated threads or tabs, and other features that allow it to engage with any and all combinations of threaded fittings of a medical device. In one or more embodiments, the syringe assembly 510 can be attached to the scrubbing device 530 using a variety of methods, including but not limited to mechanical fasteners, snap fits, and threaded connectors. In one or more embodiments, the threaded connector is disposed on the bottom outer surface of the disinfection unit 500 and has threads whose size and pitch are made to engage with the threads of the Luer lock collar on the distal end of the syringe barrel so as to allow the assembled disinfection unit 500 to be connected to a syringe. In such Figure 1In one or more embodiments shown, the bottom wall 531 of the scrubbing device 530 includes a threaded post 532 disposed at the center of the bottom wall 531 adjacent the common dividing wall 560 that corresponds to the internal threads 520 of the locking Luer-type collar 519 on the distal end of the syringe barrel 511 .

[0222] When used on a needleless connector ("NFC"), the scrubbing device 530 can achieve disinfection by integrating a first disinfectant 547 in a first absorbent material 546 disposed and contained in a first chamber 545 of a first cup 540 and integrating a second disinfectant 547 in a second absorbent material 556 disposed and contained in a second chamber 555 of a cup 550. The first disinfectant and the second disinfectant (547, 557) can be directly contained in the first chamber 545 and the second chamber 555, and can be absorbed into the first absorbent material 546 and into the second absorbent material 556 (e.g., a sponge or foam material) that fill the chambers of the first cup 540 and the second cup 550, respectively. The scrubbing device 530 is designed to interact with a variety of disinfectants. In one or more embodiments, the first disinfectant 547 or the second disinfectant 557 can include a variant of alcohol or chlorhexidine. In one or more embodiments, the first disinfectant 547 or the second disinfectant 557 is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylhydroxyanisole (BHA), butylhydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate diacetate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexidine, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, octenylamine, antibiotics, and mixtures thereof. In a specific embodiment, the first disinfectant 547 or the second disinfectant 557 includes at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the first disinfectant 547 or the second disinfectant 557 is a fluid or a gel.

[0223] The first absorbent material 546 absorbs the first disinfectant 547 contained in the chamber 545 of the first cup 540. In one or more embodiments, the first absorbent material 546 is a nonwoven material, a foam, or a sponge. In a specific embodiment, the foam is a polyurethane foam. In a specific embodiment, the second absorbent material 556 is in the form of a foam plug. In one or more embodiments, the second absorbent material 556 includes one or more slits, such as Fig.26 and Fig.28 shown.

[0224] A first peelable seal 548 having a top web 49 is disposed on the engagement surface of the first cup 540 to prevent the first absorbent material 546 from leaving the first chamber 545. With the first absorbent material 546 properly inserted into the chamber 545 of the first cup 540, the first peelable seal 548 can be secured to the engagement surface of the open end 544 of the first cup 540 to seal the scrubbing device 530.

[0225] The second absorbent material 556 is placed and contained in the chamber 555 of the second cup 550, and absorbs the second disinfectant 557 contained in the chamber 555 of the second cup 550. In one or more embodiments, the absorbent material 556 is a non-woven material, foam or sponge. In a specific embodiment, the foam is a polyurethane foam. In a specific embodiment, the second absorbent material 556 is in the form of a foam plug. In one or more embodiments, the second absorbent material 556 includes one or more slits, such as Fig.26 and Fig.28 shown.

[0226] A second peelable seal 558 having a top web 559 is disposed on the engagement surface of the second cup 550 to prevent the second absorbent material 556 from leaving the chamber 555. With the second absorbent material 556 properly inserted into the chamber 555 of the second cup 550, the second peelable seal 558 can be secured to the engagement surface of the open end 554 of the second cup 550 to seal the scrubbing device 530.

[0227] The first peelable seal 548 and the second peelable seal 558 minimize the danger of potential particle ingress and also provide a substantially impermeable enclosure for the scrubbing device 530, provide a leak-proof and protective enclosure, protect the contents of the first absorbent material 546 and the second absorbent material 556 contained in the first chamber 545 and the second chamber 555, respectively, and / or maintain a sealed, sterile environment. The first peelable seal 548 and the second peelable seal 558 provide an adequate seal under a range of temperatures, pressures, and humidity levels. Figure 1 , a first peelable seal 548 and a second peelable seal 558 can be set on the corresponding open ends (544, 554) of the first cup 540 and the second cup 550 to prevent the pre-filled first and second disinfectants (547, 557) from leaving the chambers of the corresponding first cup 540 and the second cup 550.

[0228] The first peelable seal 548 and the second peelable seal 558 can be plastic sealed aluminum and can be chemical resistant, light blocking, impermeable or sterile. In one or more embodiments, the first peelable seal 548 and the second peelable seal 558 can include aluminum or a multi-layer polymer film peelable top layer. In a specific embodiment, the first peelable seal 548 and the second peelable seal 558 are heat sealed or induction sealed to the engaging surface of the open end (544, 554) of the cup (540, 550) to seal the scrubbing device 530. In one or more embodiments, the first peelable seal 548 and the second peelable seal 558 include a moisture barrier.

[0229] After the connectors are inserted into the open ends (544, 554) of the respective cups 540 and 550, the first and second absorbent materials 546, 556 and the disinfectant contact the male Luer connector, the female Luer connector, and the hemodialysis connector.

[0230] In one or more embodiments, the female connector can be selected from the group consisting of a needleless connector, a catheter Luer connector, a stopcock, and a hemodialysis connector. In one or more embodiments, the male connector can be an intravenous tubing end, a stopcock, or a male lock Luer connector.

[0231] The first cup 540 and the second cup 550 are made of any type of plastic material, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactic acid, acrylonitrile-butadiene-styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the first cup 540 and the second cup 550 include polypropylene or polyethylene materials.

[0232] In order to avoid having to use different types of disinfection caps to clean different types of connectors, the disinfection device 500 having the first cup 540 and the second cup 550 is compatible and engageable with both the male Luer connector and the female Luer connector, thereby allowing the user to use a single device to clean different types of connectors. After the first cup 540 and the second cup 550 are mounted on the female Luer connector or the male Luer connector, the female or male medical connector engages the inner wall after being inserted into the chamber 545 or 555 and contacts the first absorbent material 546 and the second absorbent material 556 soaked with disinfectant. Therefore, the device of the present disclosure can disinfect both the male Luer connector and the female Luer connector, thereby meeting the current needs in the art.

[0233] Other aspects of the present disclosure relate to methods of sterilizing medical connectors and assemblies. In one or more embodiments, a method of sterilizing a medical connector includes connecting a device of one or more embodiments to the medical connector, wherein the connection includes frictionally engaging an inner wall surface after insertion into a cavity so that the medical connector contacts an absorbent material and a sterilant.

[0234] In use, the clinician removes the first cup from the second cup of the scrubbing device, and the clinician places the first cup 540 on a sterile tray to subsequently sterilize the needleless connector ("NFC") using the sealed first cup before flushing. The clinician then peels off the top web 559 of the second peelable seal 558 from the second cup 550 before flushing the IV line. The clinician then uses the second cup 550 to sterilize the NFC. After the NFC is inserted into the second cup 550, the second absorbent material 556 soaked with the second disinfectant 557 contacts the NFC. In one or more embodiments, the NFC can be a male Luer connector, a female Luer connector, and a hemodialysis connector. Next, the clinician unscrews the second cup 550 of the scrubbing device 530 from the locking Luer-type collar 519 at the distal end of the syringe barrel 511 by applying torque to the entire assembly, thereby removing the second cup 550 of the scrubbing device 530 from the syringe barrel to allow the flushing syringe to be attached to the IV catheter line to flush the IV line. The clinician engages the thread of the Luer lock collar on the distal end of the syringe barrel to the NFC to connect the NFC to the flushing syringe. The clinician then proceeds to flush the IV line. Next, the clinician picks up the disassembled first cup 540 of the scrubbing device 530 and peels off the top web 559 from the first cup 540 after flushing the IV line to expose the first absorbent material 546 soaked in the first disinfectant 547 and uses the first cup 540 to disinfect the NFC after inserting the NFC connector into the first cup 540, wherein the first absorbent material 546 soaked in the first disinfectant 547 in the first cup 540 contacts the male Luer connector, the female Luer connector, and the hemodialysis connector. As in current practice, the clinician then administers medication and performs a second flush of the IV line using a flushing syringe to remove any medication remaining in your catheter and scrubs the hub using a disinfectant wipe or scrubbing device. The clinician then "locks" the IV line using a locking syringe filled with heparin flushing fluid to help prevent thrombus formation in the catheter. Finally, a new disinfection cap is attached to the living catheter hub.

[0235] As discussed above, current products and SASH practices do not address any cleaning after the initial flushing process, as disinfection ends after the first flush. An advantage of embodiments of the present invention including two separately packaged first and second cups 540, 550, each having an absorbent material (546, 556) loaded with disinfectant, is a two-step disinfection mechanism that provides additional protection for the patient by including an additional cleaning step of disinfecting the hub or connection interface using IPA or a scrubbing device prior to drug or lock solution infusion, thereby further preventing potential infection to the patient.

[0236] When the first cup 540 is used, after being connected to the female or male Luer connector, compression of the first absorbent material 546 toward the closed end 542 of the chamber 545 allows the connector to contact the first disinfectant 547 to disinfect the female or male Luer connector. Similarly, when the second cup 550 is used, after being connected to the female or male Luer connector, compression of the second absorbent material 556 toward the closed end 552 of the chamber 555 allows the connector to contact the second disinfectant 557 to disinfect the female or male Luer connector.

[0237] In one or more embodiments, an assembly includes a device connected to one or more embodiments of a medical connector. In one or more embodiments, the medical connector is selected from a male Luer connector, a female Luer connector, and a needle-free connector.

[0238] In another alternative embodiment, reference Fig.30 , the disinfection unit 600 includes a flushing syringe assembly 610 having a syringe barrel 611, the syringe barrel 611 having an elongated body 612 defining a chamber 613 for retaining a fluid. The syringe barrel 611 includes an open proximal end 614 having a flange 615 and a distal end 616 including a tip 617, the tip 617 having a passage 518 passing therethrough to communicate with the chamber fluid. The distal end 616 of the barrel also includes a locking Luer-type collar 619 concentrically surrounding the tip 617. The locking Luer-type collar 619 has an internal thread. The syringe assembly 610 also includes a stopper 621 connected to an elongated plunger rod 622, the elongated plunger rod 622 having a thumb press 623 at its proximal end. A tip cap 680 is threadedly connected to the distal end of the barrel to provide closed integrity for the syringe contents throughout the shelf life and is removed by the user before flushing administration. The syringe assembly 610 also includes a stopper 631 connected to an elongated plunger rod 632 having a flange 634 at its proximal end.

[0239] Two individually packaged disinfectant-loaded scrubbing pads (650, 660) are attached to the flange 615 of the syringe barrel 611 by a loop of detachable cord 640, which is attached to the flange by adhesive or threaded to a small hole 670 provided on the flange 615. Each end of the cord 640 is attached to one of the two individually packaged disinfectant-loaded scrubbing pads (650, 660). The flange 615 may have one or more notches or holes for attaching a loop of cord to the notches or holes, each end of the cord being attached to the two individually packaged disinfectant-loaded scrubbing pads (650, 660). Further, the cord may be wrapped around the grooves, notches or holes in the flange to facilitate the user's gripping of the two individually packaged disinfectant-loaded scrubbing pads (650, 660). The two individually packaged disinfectant-loaded scrub pads (650, 660) provided enforce a disinfection solution that might not otherwise be followed and provide additional protection for the patient by including an additional cleaning step of disinfecting the hub or connection interface using IPA or a scrubbing device prior to medication or lock solution infusion, thereby further preventing potential infection to the patient.

[0240] In use, the catheter to which the flushing syringe will be connected needs to be disinfected with one of two independently packaged disinfectant-loaded scrub pads (650, 660). In use, the clinician removes the first of the two independently packaged disinfectant-loaded scrub pads (650), and the clinician places the first independently packaged disinfectant-loaded scrub pad (650) on a sterile tray for subsequent use before flushing. Then, the clinician opens the independently packaged disinfectant-loaded scrub pad (650) before flushing the IV line. Then the clinician uses the independently packaged disinfectant-loaded scrub pad (650) to disinfect the NFC by contacting the NFC with the independently packaged disinfectant-loaded scrub pad (650). In one or more embodiments, the NFC can be a male Luer connector, a female Luer connector, or a hemodialysis connector. Next, the clinician engages the thread of the Luer lock collar on the distal end of the syringe barrel to the NFC to connect the NFC to the flushing syringe. Then the clinician continues to flush the IV line. Next, the clinician opens the individually packaged disinfectant-loaded scrub pad (660) and accesses the male Luer connector, the female Luer connector, and the hemodialysis connector.

[0241] As discussed above, current products and SASH practices do not address any cleaning after the initial flushing process, as disinfection ends after the first flush. An advantage of embodiments of the present invention including two independently packaged disinfectant-loaded scrub pads (650, 660) is a two-step disinfection mechanism that provides additional protection for the patient by including an additional cleaning step of disinfecting the hub or connection interface using IPA or a scrub device prior to drug or lock solution infusion, thereby further preventing potential infection to the patient.

[0242] In another alternative embodiment, reference Fig.31 , the disinfection unit 700 includes a flushing syringe assembly 710 having a syringe barrel 711, the syringe barrel 711 having an elongated body 712 defining a chamber 713 for retaining a fluid. The syringe barrel 711 includes an open proximal end 714 having a flange 715 and a distal end 716 including a tip 717 having a passage 518 passing therethrough to communicate with the chamber fluid. The distal end 716 of the barrel also includes a locking Luer-type collar 719 concentrically surrounding the tip 717. The locking Luer-type collar 719 has an internal thread. The syringe assembly 710 also includes a stopper 721 connected to an elongated plunger rod 722 having a thumb press 723 at its proximal end. A tip cap 780 is threadedly connected to the distal end of the barrel to provide closed integrity for the syringe contents throughout the shelf life and is removed by the user before flushing administration. The syringe assembly 710 also includes a stopper 731 connected to an elongated plunger rod 732 having a flange 734 at its proximal end.

[0243] Two independently packaged disinfectant-loaded scrub pads (750, 760) are attached to the elongated body 712 of the syringe barrel 710 using an adhesive or an outer plastic wrap. The two independently packaged disinfectant-loaded scrub pads (750, 760) provided enforce a disinfection solution that may not otherwise be followed and provide additional protection to the patient by including an additional cleaning step of disinfecting the hub or connection interface using IPA or a scrubbing device prior to drug or lock solution infusion, thereby further preventing potential infection to the patient. The syringe assembly 710 can be a pre-filled syringe assembly. It is understood that the two disinfectant-loaded scrub pads (750, 760) can be linked or connected together by a frangible or perforated portion to facilitate removal from the syringe barrel or syringe assembly. In an alternative embodiment, the two independently loaded disinfectant scrub pads (750, 760) can be adhered to the syringe barrel using a shrink-wrap type label that can surround a portion of the barrel until the practitioner is ready to use the syringe assembly.

[0244] The catheter to which the flushing syringe will be connected needs to be disinfected with one of two independently packaged disinfectant-loaded scrub pads (650, 660). In use, the clinician removes the first of the two independently packaged disinfectant-loaded scrub pads (750) from the elongated body 712 of the syringe barrel 710, and the clinician places the first independently packaged disinfectant-loaded scrub pad (650) on a sterile tray for subsequent use before flushing. The clinician then removes the second of the two independently packaged disinfectant-loaded scrub pads (760) from the elongated body 712 of the syringe barrel 710 and opens the independently packaged disinfectant-loaded scrub pad (750) before flushing the IV line. The clinician then uses the independently packaged disinfectant-loaded scrub pad (750) to disinfect the needleless connector ("NFC") by contacting the NFC with the disinfectant-loaded scrub pad (750). In one or more embodiments, the NFC can be a male Luer connector, a female Luer connector, or a hemodialysis connector. Next, the clinician threads the Luer lock collar on the distal end of the syringe barrel to the NFC to connect the NFC to the flush syringe. The clinician then proceeds to flush the IV line. Next, the clinician opens the first individually packaged disinfectant-loaded scrub pad (750) and accesses the male Luer connector, the female Luer connector, and the hemodialysis connector.

[0245] As discussed above, current products and SASH practices do not address any cleaning after the initial flushing process, as disinfection ends after the first flush. An advantage of embodiments of the present invention including two independently packaged disinfectant-loaded scrub pads (750, 760) is a two-step disinfection mechanism that provides additional protection for the patient by including an additional cleaning step of disinfecting the hub or connection interface using IPA or a scrub device prior to drug or lock solution infusion, thereby further preventing potential infection to the patient.

[0246] Although the present disclosure has been shown and described with reference to certain exemplary embodiments thereof, it will be appreciated by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the embodiments of the present disclosure. Moreover, the interior and / or exterior housing of the cap may be single shot injection molded or made by other suitable processes. In addition, as will be readily appreciated by those skilled in the art, any features or elements of any exemplary implementation of the embodiments of the present disclosure as described above and shown in the accompanying drawings may be implemented individually or in any combination without departing from the spirit and scope of the embodiments of the present disclosure.

[0247] In addition, the included drawings further describe non-limiting examples of implementation of certain exemplary embodiments of the present disclosure and help describe the technology associated therewith. Except as described above, any specific or relative dimensions or measurements provided in the drawings are exemplary and are not intended to limit the scope or content of the present invention design or method as understood by those skilled in the art to which the present invention relates.

[0248] 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 accompanying drawings, disclose exemplary embodiments of the disclosure.

[0249] References throughout the specification to "one embodiment," "certain embodiments," "one or more embodiments," or "an embodiment" mean that a particular feature, structure, material, or characteristic described in conjunction with the embodiment is included in at least one embodiment of the present disclosure. Thus, phrases such as "in one or more embodiments," "in certain embodiments," "in an embodiment," or "in an embodiment" appearing in different places throughout the specification do not necessarily refer to the same embodiment of the present disclosure. Furthermore, in one or more embodiments, the particular features, structures, materials, or characteristics may be combined in any suitable manner.

[0250] Although the present disclosure is described in conjunction with specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It is apparent to those skilled in the art that various modifications and variations may be made to the methods and apparatus of the present disclosure without departing from the spirit and scope of the present disclosure. Therefore, the present disclosure is intended to include modifications and variations within the scope of the appended claims and their equivalents.

Claims

1. A disinfection device, characterized in that include: a scrubbing device having a first cup, a second cup, and a bottom wall spanning across the first cup and the second cup, The first cup includes a first integral body, a first closed end, and a first opening end extending from the first closed end to the first open end. C and a first annular wall defining a first chamber containing a first absorbent material and a first disinfectant, the first open end having a peripheral boss extending radially inwardly from the first open end to define an end face and an engagement surface; a first peelable seal disposed on the end surface of the first cup to prevent the first disinfectant from leaving the first chamber; a connecting element disposed on the bottom wall of the first cup of the scrubbing device; The second cup includes a second integral body, a second closed end, and a second cup extending from the second closed end to the second open end with a length L C and a second annular wall defining a second chamber containing a second absorbent material and a second disinfectant, the second open end having a peripheral boss extending radially inwardly from the second open end to define a second end surface and a second engagement surface; and A second peelable seal is disposed on the second end surface of the second cup to prevent the second disinfectant from leaving the second chamber.

2. The disinfection device according to claim 1, characterized in that The connecting element is a threaded stud.

3. The disinfection device according to claim 2, characterized in that The connecting element is a Luer lock collar.

4. The disinfection device according to claim 2, characterized in that The threaded post mates with the Luer lock collar of the flushing syringe.

5. The disinfection device according to claim 1, characterized in that The peripheral boss is sized and adapted to receive a thumb press portion of the plunger rod.

6. The disinfection device according to claim 1, characterized in that The first cup and the second cup include polypropylene or polyethylene material.

7. The disinfection device according to claim 1, characterized in that The first absorbent material and the second absorbent material are foams.

8. The disinfection device according to claim 7, characterized in that The first absorbent material and the second absorbent material are polyurethane foams.

9. The disinfection device according to claim 1, characterized in that The first absorbent material and the second absorbent material are sponges.

10. The disinfection device according to claim 1, characterized in that The first absorbent material and the second absorbent material have slits.

11. The disinfection device according to claim 1, characterized in that Once connected to the medical connector, compression of the first and second absorbent materials towards the first closed ends of the first and second chambers occurs.

12. The disinfection device according to claim 11, characterized in that Contact with the first absorbent material and the second absorbent material sterilizes the medical connector.

13. The disinfection device according to claim 1, characterized in that The first disinfectant and the second disinfectant are fluids or gels.

14. The disinfection device according to claim 1, characterized in that The first peelable seal and the second peelable seal may include aluminum or a multi-layer polymer film peelable top layer.

15. The disinfection device according to claim 1, characterized in that The first and second peelable seals may be heat or induction sealed to the engaging surfaces.

16. A component, characterized in that It includes: The disinfection device of claim 1 connected to a syringe assembly comprising a syringe barrel having an elongated body defining a chamber, an open proximal end having a flange, and a distal end having a tip having a passage therein in fluid communication with the chamber, a stopper connected to an elongated plunger rod, and a locking Luer-type collar on a distal end of the syringe barrel, the syringe barrel having an elongated body defining a chamber, an open proximal end having a flange, and a distal end having a tip having a passage therein in fluid communication with the chamber, the elongated plunger rod having a thumb press at its proximal end; The first cup is connected to the locking Luer-type collar on the distal end of the syringe barrel; and The second cup of the scrubbing device is snap-fitted to the thumb press portion of the elongated plunger rod of the syringe assembly.

Images