Flushing syringe with multiple scrubbing devices

Abstract

An integrated disinfection device is described, a syringe assembly having two integrated disinfection units assembled to a syringe for disinfecting and sterilizing a corresponding medical connector, in particular an access port of a corresponding medical connector. 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 antibacterial agent in the first cup, and a first peelable seal. The second cup has a chamber and a second peelable seal, the chamber of the second cup containing a second absorbent material, a second disinfectant or antibacterial agent in the second cup. A threaded connection is disposed on a bottom outer surface of the first cup, the threaded connection having a thread sized and pitch designed to engage with a thread of a Luer lock 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 thumb press portion of the syringe and the boss of the second cup.

Description

Technical Field

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

[0002] Vascular access devices (VADs) are commonly used therapeutic devices that include intravenous (IV) catheters and needleless access devices. The operation of VADs is often impaired or completely blocked due to the occurrence of thrombosis. Thrombosis refers to the development of blood clots in blood vessels and / or within the vascular access device. If not properly maintained or if exposed to a non-sterile environment, VADs can become contaminated, blocked by blood clots, or transmit infections. Once connected to a VAD to deliver fluids or medications, bacteria and other microorganisms can enter the patient's vascular system through the access hub, port, or valve. Each access hub, port, valve, or connector is associated with some risk of transmitting catheter-related bloodstream infections (CRBSIs), which can be costly and potentially fatal. To reduce the number of CRBSI cases and ensure the proper use and maintenance of VADs, practice standards have been developed, which include disinfection and cleaning procedures. To ensure that VADs are properly used and not blocked or infected, protocols for ensuring aseptic practice have been developed. These protocols include disinfecting the VAD and flushing the catheter with a flush solution. Syringe assemblies filled with various fluids are used to flush the catheter. In some cases, different fluids are injected sequentially according to the protocol. For example, a saline solution is then followed by an anticoagulant such as heparin. VAD protocols generally recommend flushing procedures after catheter placement, before fluid infusion, and before and after medication administration, blood sampling, blood transfusion, and parenteral nutrition. The purpose of these flushing procedures is to confirm catheter patency, avoid drug incompatibilities, ensure complete drug dose administration, prevent thrombosis, and minimize the risk of bloodstream infections.

[0003] In developed markets, when using an intravenous catheter, a needleless connector is typically used to close the system and then accessed to administer medications or other necessary fluids to a patient via the catheter. The Infusion Nurses Society ("INS") Standards of Practice recommend the use of needleless connectors and state that "prior to each access, persistent and thorough disinfection should be performed using alcohol, tincture of iodine, or chlorhexidine gluconate / alcohol mixture." The ultimate goal of disinfecting the needleless connector is to help reduce bacteria that may survive on the surface and that can cause various catheter-related complications, including CRBSI. Nurses typically use 70% isopropyl alcohol (IPA) pads to perform this disinfection task by performing what is known as a "scrub of the hub." However, compliance with this practice is typically low. In addition to the lack of compliance with the "scrub of the hub," it has also been noted through interviews with clinicians that there are often variations in the scrub time, dry time, and the number of times the needleless connector is scrubbed.

[0004] Throughout the entire series of procedures related to the transmission of microorganisms that can cause CRBSI, there are numerous risks of contact or contamination. For example, contamination can occur during medication mixing, cannula attachment, and insertion of the access hub. In addition, threaded connectors have open Luer with exposed lumens. Since the procedures for connecting to a VAD are very common and simple, the risks associated with accessing the patient's vascular system are often overlooked. Currently, the risks faced by hospitals and patients mainly depend on whether the clinician performing the connection is diligent, and this diligence is largely uncontrollable.

[0005] VAD standards and practices typically include disinfecting both the threaded male connector and the IV catheter connection site. The additional disinfection steps reduce the likelihood of contamination but also increase the likelihood of non-compliance with the disinfection procedure.

[0006] The current "recommended practice" for aseptic intravenous line maintenance and intravenous drug delivery procedures requires compliance with a step-by-step process called "SASH". In the first step of this process, the clinician cleans / disinfects (usually with an alcohol wipe) the VAD connector. In the second step, the intravenous line or catheter is flushed with a syringe containing saline (saline flush), and then the VAD connector is disinfected a second time. In the third step, fluid or drug therapy is administered through the intravenous line or catheter (drug administration therapy), the VAD connector is disinfected a third time, and then a second saline flush step is performed. Depending on the patient's needs and institutional policy, the final step is to perform a final disinfection of the VAD connector, followed by a heparin lock step in which a small amount of heparin is injected into the intravenous line or catheter to prevent the formation of thrombi or blood clots. A separate disinfection cap can be used to disinfect the seat of the VAD. This "recommended practice" requires the disinfection of the VAD connector after each access, making the maintenance of the intravenous line a very cumbersome and time-consuming process. Because this process is so cumbersome, it is unlikely that clinicians will fully perform this "recommended practice", thereby exposing patients to the risk of contracting CRBSI. Microorganisms can multiply on the exposed connector entry surface, and if the "recommended practice" is not followed, the microorganisms may enter the intravenous line during the flushing process. In addition, blood reflux into the intravenous line or catheter can cause clots to form within the intravenous line, and microorganisms from the connector entry surface may colonize the blood clots within the line and infect the patient during flushing.

[0007] The current practice is to require the user to obtain a separate disinfection unit product to ensure the cleanliness of the VAD connector, for example, after a saline flush and before the next procedure (e.g., drug injection). Therefore, there is a need for an integrated disinfection unit that is assembled to a syringe, which promotes compliance with aseptic techniques by eliminating additional wiping and disinfection steps and simultaneously reducing the number of separate flushing and disinfection devices used in the current practice.

[0008] Currently, the workflow for seat disinfection is implemented using only a single device, which is typically an IPA pad or a similar IPA scrubbing device. After disinfection, the pipeline is rinsed with a syringe. Next, the drug is administered to the patient. Since IPA pads or scrubbing devices are not easily accessible, it is easy to miss disinfecting the seat before this drug administration. Next, a second rinse is performed to clean the pipeline. If the IPA pad or scrubbing device is integrated with the rinsing syringe, the IPA pad or scrubbing device is used to clean the seat before use. Finally, the pipeline is locked with a locking solution (e.g., heparin), but since IPA pads or scrubbing devices are not easily accessible, the seat is not disinfected before drug administration. Current products and practices do not involve any cleaning after rinsing because disinfection ends after rinsing. The INS guidelines also recommend cleaning the connector before each access. Therefore, the solutions currently on the market do not include an additional scrubbing device to enforce disinfection before administering the drug or the lock solution.

[0009] Therefore, there is a need to provide a device that includes two or more IPA pads or scrubbing devices to disinfect the seat or the connection interface before administering the drug or the lock solution. Summary of the Invention

[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 across the entire first cup and second cup.

[0011] The first cup includes an integral body, a closed end, an annular wall having a length L extending from the closed end to an open end C , and a first peelable seal having a top web, the annular wall defining a chamber that houses a first absorbent material, a first disinfectant, or an antibacterial agent. The first peelable seal has a bottom surface and a top surface.

[0012] The second cup includes an integral body, a closed end, an annular wall having a length L extending from the closed end to an open end C , and a second peelable seal having a top web, the annular wall defining a chamber that houses a second absorbent material, a second disinfectant, or an antibacterial 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 antibacterial agent.

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

[0014] The connecting element is disposed on the bottom wall of the scrubbing device, thereby allowing the scrubbing device to be connected to a syringe. In one or more embodiments, the syringe assembly can be attached to the scrubbing device using various methods, including but not limited to mechanical fasteners, snap fittings, and threaded connections. In one or more embodiments, the connecting element is a threaded connection portion and can include integral threads or tabs. In a specific embodiment, the connecting element is a threaded Luer connection portion. In one or more embodiments, a threaded connection portion is provided on the outer bottom surface of the first cup of the disinfection unit, the threaded connection portion having threads sized and pitched to engage the threads of a Luer lock collar on the distal 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 post disposed in the center of the bottom wall of the first cup, the threaded post corresponding to the internal threads of a locking Luer-type collar on the distal end of the syringe barrel.

[0015] The second cup and the syringe assembly are interlocked by an interference fit or snap fit between the thumb press of the syringe and the boss of the second cup. A boss or wedge portion can be disposed 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 inner surface of the top wall of the second cup disposed at the closed end of the annular wall of the second cup can have a recess, a boss, or a wedge portion 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 side wall extending radially inward in a vertical direction from the annular wall. The second cup is adapted to snap fit onto the thumb press of the plunger rod and is opposite the Luer end. In one or more embodiments, the second cup can be connected to a thumb press having an edge disposed radially inward on a peripheral boss to form a lip or edge.

[0017] In one or more embodiments, the inner surface of the peripheral boss in the inner annular wall surface at the closed end of the second cup 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 effect disinfection by integrating a first disinfectant or antimicrobial agent in a first absorbent material disposed and contained within a first chamber of a cup and a second disinfectant or antimicrobial agent in a second absorbent material disposed and contained within a second chamber of a second cup. The first disinfectant or antimicrobial agent and the second disinfectant or antimicrobial agent can be directly included within the first and second chambers and can be absorbed into the first absorbent material and the second absorbent material, respectively (e.g., a sponge or foam material), with the first absorbent material and the second absorbent material filling the chambers of the first and second cups, respectively. The scrubbing device is designed to be compatible with and interact 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 a variant of alcohol 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, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In a specific embodiment, the first disinfectant or antimicrobial agent or the second disinfectant or antimicrobial agent includes 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 non-woven 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 disposed on the mating surface of the cup to prevent the first absorbent material from leaving the chamber. In the case where the first absorbent material is properly inserted into the chamber of the cup, the first peelable seal can be secured to the mating surface of the open end of the first cup to seal the scrubbing device.

[0021] A second absorbent material is disposed and contained within the chamber of the cup and absorbs a second disinfectant or antimicrobial agent contained within the chamber of the second cup. In one or more embodiments, the second absorbent material 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 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 disposed on the mating surface of the cup to prevent the second absorbent material from leaving the chamber. In the case where the second absorbent material is properly inserted into the chamber of the cup, the second peelable seal can be secured to the mating surface of the open end of the second cup to seal the scrubbing device.

[0023] Both the first peelable seal and the second peelable seal can be chemical resistant, light blocking, impermeable, or sterile. In one or more embodiments, the first peelable seal and the second peelable seal include an aluminum or multi-layer polymer film peel back top. In a specific embodiment, the first peelable seal and the second peelable seal are heat sealed or induction sealed to the mating 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 a polypropylene or polyethylene material.

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

[0026] Another aspect of the present disclosure relates to a method of disinfecting a medical connector, the method comprising: connecting a disinfection device according to an embodiment of the present disclosure to the medical connector, wherein the connection includes removing a second cup from a syringe assembly and peeling 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 with a disinfectant or an antibacterial agent; subsequently, unscrewing a scrubbing device from a locking Luer collar at a distal end of a barrel by applying torque to the entire assembly, and removing the first cup of the scrubbing device from the syringe barrel; attaching a flush syringe to an IV catheter line and flushing the IV line by engaging a threaded Luer lock collar on a distal end of the syringe barrel to connect the NFC to the flush syringe; unscrewing the flush syringe from the NFC, and peeling a 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 with a disinfectant or an antibacterial agent.

[0027] This summary is intended to introduce a selection of concepts in a simplified form that will be 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 to assist in determining the scope of the claimed subject matter.

[0028] Other features and advantages of the present disclosure will be set forth in the following description, and in part will be obvious from the description, or may be learned by practice of the present disclosure. The features and advantages of the present disclosure may be realized and obtained by means of the instrumentalities and combinations particularly pointed out in the appended claims. These and other features of the present disclosure will become more apparent from the following description and the appended claims, or may be learned by practice of the present disclosure set forth below. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 A perspective view of a disinfection unit 100 according to an exemplary first embodiment of the present disclosure is shown;

[0030] Figure 2 A cross-sectional view of a disinfection unit 100 according to an exemplary first embodiment of the present disclosure is shown;

[0031] Figure 3 An exploded perspective view of a disinfection unit 100 according to an exemplary first embodiment of the present disclosure is shown;

[0032] Figure 4 A bottom perspective view of a scrubbing element according to an exemplary first embodiment of the present disclosure is shown;

[0033] Figure 5Shows a top perspective view of a scrubbing element according to an exemplary first embodiment of the present disclosure;

[0034] Figure 6 Shows a flowchart of a disinfection process using a disinfection unit 100 according to an exemplary first embodiment of the present disclosure;

[0035] Figure 7 Shows a perspective view of a disinfection unit 200 according to an exemplary second embodiment of the present disclosure;

[0036] Figure 8 Shows a cross-sectional view of a disinfection unit 200 according to an exemplary second embodiment of the present disclosure;

[0037] Figure 9 Shows an exploded perspective view of a disinfection unit 200 according to an exemplary second embodiment of the present disclosure;

[0038] Figure 10 Shows a perspective side view of a scrubbing element according to an exemplary second embodiment of the present disclosure;

[0039] Figure 11 Shows a perspective view of a scrubbing element according to an exemplary second embodiment of the present disclosure, wherein the second cup is removed from the first cup;

[0040] Figure 12 Shows a flowchart of a disinfection process using a disinfection unit 200 according to an exemplary second embodiment of the present disclosure;

[0041] Figure 13 Shows a perspective view of a disinfection unit 300 according to an exemplary third embodiment of the present disclosure;

[0042] Figure 14 Shows a cross-sectional view of a disinfection unit 300 according to an exemplary third embodiment of the present disclosure;

[0043] Figure 15 Shows an exploded perspective view of a disinfection unit 300 according to an exemplary third embodiment of the present disclosure;

[0044] Figure 16 Shows a perspective side view of a scrubbing element according to an exemplary third embodiment of the present disclosure;

[0045] Figure 17 Shows a perspective view of a scrubbing element according to an exemplary third embodiment of the present disclosure, wherein the second cup is removed from the first cup;

[0046] Figure 18 Shows a flowchart of a disinfection process using a disinfection unit 200 according to an exemplary third embodiment of the present disclosure;

[0047] Figure 19 A perspective view of a disinfection unit 400 according to an exemplary fourth embodiment of the present disclosure is shown;

[0048] Figure 20 A cross-sectional view of a disinfection unit 400 according to an exemplary fourth embodiment of the present disclosure is shown;

[0049] Figure 21 An exploded perspective view of a disinfection unit 400 according to an exemplary fourth embodiment of the present disclosure is shown;

[0050] Figure 22 A perspective side view of a first cup and a second cup of a scrubbing element according to an exemplary fourth embodiment of the present disclosure is shown;

[0051] Figure 23 A flowchart of a disinfection process using a disinfection unit 400 according to an exemplary fourth embodiment of the present disclosure is shown;

[0052] Figure 24 A perspective view of a disinfection unit 500 according to an exemplary fifth embodiment of the present disclosure is shown;

[0053] Figure 25 A cross-sectional view of a disinfection unit 500 according to an exemplary fifth embodiment of the present disclosure is shown;

[0054] Figure 26 An exploded perspective view of a disinfection unit 500 according to an exemplary fifth embodiment of the present disclosure is shown;

[0055] Figure 27 A perspective side view of a scrubbing element according to an exemplary fifth embodiment of the present disclosure is shown;

[0056] Figure 28 A perspective view of a scrubbing element according to an exemplary fifth embodiment of the present disclosure, in which the second cup is detached from the first cup;

[0057] Figure 29 A flowchart of a disinfection process using a disinfection unit 500 according to an exemplary fifth embodiment of the present disclosure is shown;

[0058] Figure 30 A perspective view of a disinfection unit 600 according to an exemplary sixth embodiment of the present disclosure is shown; and

[0059] Figure 31 A perspective view of a disinfection unit 700 according to an exemplary seventh embodiment of the present disclosure is shown. Detailed Description

[0060] In current practice of the SASH (Saline - Administration - Saline - Heparin) workflow, the clinician removes the disinfection cap attached to the indwelling catheter hub to be flushed and proceeds to use a disinfection wipe or scrubbing device to scrub the hub. Next, the clinician uses a flush syringe to flush the intravenous (IV) line to ensure the catheter is working prior to infusion. After the first flush, the clinician then uses a disinfection wipe or scrubbing device to scrub the hub and administers medication into the IV line. After administration, the clinician again uses a disinfection wipe or scrubbing device to scrub the hub. Then, the clinician uses the flush syringe to perform a second flush of the IV line to clear any remaining medication in your catheter and uses a disinfection wipe or scrubbing device to scrub the hub. After that, the clinician uses a locking syringe filled with heparin flush to "lock" the IV line to help prevent blood clots from forming in the catheter. Finally, a new disinfection cap is attached to the indwelling catheter hub. Thus, the current practice requires 4 scrubbing devices, 2 flush syringes, 1 disinfection cap, and 1 locking syringe.

[0061] 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 construction or process steps set forth in the following description. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0062] Embodiments of the present disclosure relate to a disinfection unit for connection to a medical connector, the disinfection unit including a syringe assembly and having two integrated disinfection units assembled to the syringe assembly for connection to and disinfection of corresponding medical connectors (including threaded connectors). In one or more embodiments, the connector is a male Luer connector or a female Luer connector. The present disclosure aims to provide a mechanism that can disinfect both the lumen of an open Luer and a corresponding intravenous connector and at the same time minimize additional steps in medical administration. It is contemplated that the disinfection unit disclosed herein can be used with a male threaded connector or a female threaded connector. The present disclosure aims to provide a mechanism for disinfecting an intravenous needleless connector during syringe use, thereby saving the clinician's time and reducing the number of work steps. The present disclosure aims to reduce the number of steps required in preventing contamination of a vascular access device (VAD).

[0063] For the terms used in the present disclosure, the following definitions are provided.

[0064] As used herein, the use of "a", "an", and "the" includes both singular and plural.

[0065] As used herein, the term "catheter - related bloodstream infection" or "CRBSI" refers to any infection caused by the presence of a catheter or an intravenous line.

[0066] As used herein, the term "Luer connector" refers to a connecting collar that is the standard way to attach syringes, catheters, needle with hub, intravenous tubing, etc. to each other. A Luer connector consists of male and female interlocking tubes that are slightly tapered so as to stay together with a simple press / twist fit. The Luer connector may optionally include an additional threaded outer rim to make them more secure. The male end of the Luer connector is typically associated with a flush syringe and can be interlocked and connected to the female end located on a vascular access device (VAD). The Luer connector includes a distal end, a proximal end, an outer wall of irregular shape, and a shaped central passage 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 passage for releasably attaching the Luer connector to the hub of the VAD and a proximal passage for releasably attaching the Luer connector to the barrel of the syringe.

[0067] As used herein, the term "syringe" refers to a simple pump-like device that consists of a plunger rod tightly fitted within a barrel or tube. The plunger rod can be pulled or pushed along the inside of the barrel, allowing the syringe to draw in and expel liquid or gas through an opening at the open end of the barrel. In one or more embodiments, the syringe is a flush syringe filled with a flush solution.

[0068] The "prefilled syringe assembly" mentioned includes a syringe that has been filled with a solution or drug using a sterile filling method during or after assembling the syringe before delivery to the user. The prefilled syringe assembly includes a syringe assembly for indicating to flush a vascular access device (VAD).

[0069] As used herein, the term "medical device" refers to a common medical device having a threaded or interlocking connection portion with a corresponding mating element. By way of example and not limitation, a syringe has a male threaded connection portion that releasably interlocks with a female Luer connection portion of a secondary medical device (such as a catheter, intravenous line, etc.). The threaded connection portion includes an inner cavity defining a fluid path surrounded by a protruding wall having a threaded device for attachment to the secondary medical device.

[0070] As used herein, the term "disinfectant" includes antibacterial agents.

[0071] Those skilled in the relevant art will readily understand that although descriptive terms such as "thread", "tab", "wall", "top", "side", "bottom", or others are used throughout this specification for ease of understanding, this is not intended to limit any of the components that can be used either in combination or alone to achieve the various aspects of the embodiments of the present disclosure.

[0072] The matters exemplified in this specification are provided to assist in a comprehensive understanding of the exemplary embodiments of the present disclosure. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the present disclosure. In addition, descriptions of well-known functions and structures are omitted for clarity and conciseness. 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 construction or process steps set forth in the following description. The present disclosure can have other embodiments and can be practiced or implemented in various ways.

[0073] Clinicians need to manipulate multiple components while accessing an intravenous (IV) line or catheter as they need to open and disinfect the hub, open the syringe, hold the line in place, etc., all while ensuring that no device touches any surface as this can lead to contamination and bloodstream infections that can have fatal consequences. Thus, accessing an intravenous (IV) line or catheter is not simple and requires a degree of dexterity to perform the procedure while also preventing the syringe tip from contacting the surrounding environment. If the syringe tip touches any non-sterile surface, "touch" contamination occurs, which can lead to microbial growth within the intravenous line, and in turn, catheter-related bloodstream infections ("CRBSI") and central line-associated bloodstream infections ("CLABSI") events, which are costly and fatal.

[0074] Embodiments of the present disclosure relate to a disinfection unit that includes a pre-filled syringe assembly having two integrated disinfection units assembled to the syringe. The disinfection unit provides measures for mechanical and chemical disinfection, i.e., a scrubbing unit (foam, etc.) and a chemical disinfectant (alcohol, etc.).

[0075] The flush syringe houses a flush solution (e.g., saline or other medication) during the product's shelf life and enables the delivery of such saline during use, i.e., the syringe is connected to the hub (e.g., needleless connector, etc.) and delivers the syringe contents.

[0076] The disinfection unit provides a disinfection measure for the hub through mechanical and chemical disinfection. The disinfection unit houses a chemical disinfectant (e.g., 70% isopropyl alcohol) during the product's shelf life.

[0077] As discussed below, embodiments of the present disclosure allow a disinfection unit to be non-permanently coupled to a syringe unit for performing disinfection and subsequent flushing procedures in accordance with the standard SASH procedure. Embodiments of the present disclosure provide non-permanent mechanical or chemical means (e.g., adhesives) for coupling the disinfection unit to the syringe. Embodiments of the present disclosure use adhesives, threaded connections, or flexible elements (e.g., clips) on the syringe or the disinfection unit to engage the disinfection unit with the syringe tip or thumb press on the component pipeline. The threaded connection or flexible element (e.g., clip, tab, etc.) can be provided on either the disinfection unit or the syringe (engaging, locking with corresponding mating features on the other component, and preventing detachment once the disinfection unit and syringe tip cap are assembled until the clinician needs to use it). In one or more embodiments, an adhesive can be applied on the contact surface between two disinfection units to bond the two disinfection units and prevent detachment until the clinician needs to use it.

[0078] Referring now to the drawings, in which like reference numerals represent like or corresponding parts in multiple views, embodiments of the present disclosure are described as follows.

[0079] Referring Figures 1 to 6 , the disinfection unit 100 for connecting to a medical connector according to a first exemplary embodiment of the present disclosure generally further 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.

[0080] Referring Figure 1 , the assembly for connecting to a medical connector includes a syringe assembly 110 having a syringe barrel 111 with an elongated body 112 that defines a chamber 113 for retaining fluid. Referring 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 therethrough that is in fluid communication with the chamber. The distal end 116 of the barrel further includes a locking Luer collar 119 that concentrically surrounds the tip 117. The locking Luer collar 119 has internal threads 120. The syringe assembly 110 further includes a stopper 121 connected to an elongated plunger rod 122 that has a thumb press 123 at its proximal end.

[0081] Referring Figures 1 to 5 , the first cup 140 includes a one-piece body 141, a closed end 142, and has a length L extending from the closed end 142 to an open end 144 Can annular wall 143, and a first peelable seal 148, the annular wall defining a chamber 145 that houses a first absorbent material 146 and a first disinfectant within a first cup 140. The first absorbent material 146 is soaked in the first disinfectant. The open end 144 defines a mating surface for contact with a first peelable seal 148 having a top web 149. Refer to 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 the open end 144.

[0082] Refer to Figures 1 - 6 the second cup 150 includes a one-piece body 151, a closed end 152, and an annular wall 153 having a length L extending from the closed end 152 to an open end 154 C and a second peelable seal 158 having a top web 159, the annular wall defining a second chamber 155 that houses a second absorbent material 156 and a second disinfectant 157 within the second cup 150. The second absorbent material 156 is soaked in the second disinfectant 157 or an antibacterial agent. The open end 154 defines a mating surface for contact with the second peelable seal 158. Refer to 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 the open end 154.

[0083] The first cup 140 and the second cup 150 are arranged in a side-by-side orientation and are defined or bounded by a common partition wall 160.

[0084] As Figures 1 to 3 shown, the syringe assembly 110 can be attached to a scrubbing device 130 having mechanical mating features. Once assembled, the assembly formed by the syringe assembly 110 and the scrubbing device 130 can withstand axial, radial, and disassembly forces. To remove the scrubbing device 130 from the syringe barrel, the user should apply a torque to the entire assembly to screw the scrubbing device 130 off of a locking Luer collar 119 at the distal end of the barrel to allow attachment of a flush syringe to an intravenous catheter line. When a torque is applied to either or both of the syringe or the scrubbing device 130, the scrubbing device 130 should unscrew and disengage from the barrel.

[0085] In the prior art, a "cradle" underside was employed below the position of the holding disinfection unit, thereby enabling the user to easily disassemble the cradle during normal use. The assembly formed by the scrubbing device 130 of the present disclosure and the collar of the syringe does not require a separate "cradle" or other device to assemble these devices together.

[0086] In Figures 1 - 3 one or more 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 transportation, use, and the product's shelf life. The scrubbing device 130 of the present disclosure is assembled with the collar of the syringe via a mechanical connection or a threaded connection, which facilitates high-speed and automated assembly.

[0087] Compared with currently available separate rinse syringe and disinfection unit products, embodiments of the integrated disinfection unit of the present disclosure provide easy access to the disinfection product at each rinse and easier manual operation during disinfection prior to rinsing.

[0088] In one or more embodiments, the disinfection unit 100 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 100 to be connected to a syringe. In an exemplary implementation of an embodiment of the present disclosure, the disinfection unit 100 includes an integrated thread or tab, and any other features that allow it to be interfaced with the threaded fitting 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 various methods, including but not limited to mechanical fasteners, snap fittings, and threaded connections. In one or more embodiments, the threaded connection is provided 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 unit 100 to be connected to a syringe. As Figure 1 shown, in one or more embodiments, the bottom wall 131 of the scrubbing device 130 includes a threaded post 132 disposed at the center of the bottom wall 131 and abutting the common partition wall 160, the threaded post corresponding to the internal threads 120 of a locking Luer-type collar 119 on the distal end of the syringe barrel 111. In one or more alternative embodiments, the partition wall 160 can divide a single cup into two separate cups.

[0089] Referring to Figure 6, when used on a needleless connector (“NFC”) medical connector 900, the scrubbing device 130 can achieve disinfection by integrating a first disinfectant 147 into a first absorbent material 146 disposed and contained in a first chamber 145 of a first cup 140 and integrating a second disinfectant 157 into a second absorbent material 156 disposed 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) that respectively fill the chambers of the first cup 140 and the second cup 150. The scrubbing device 130 is designed to be compatible with and interact with various disinfectants. In one or more embodiments, the first disinfectant 147 or the second disinfectant 157 can include a variant of alcohol 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, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In a specific embodiment, the first disinfectant 147 or the second disinfectant 157 includes at least one of chlorhexidine gluconate and chlorhexidine acetate. In one or more embodiments, the first disinfectant 147 or the second disinfectant 157 is a fluid or a gel.

[0090] The first absorbent material 146 absorbs the first disinfectant 147 or the antimicrobial agent contained within the chamber 145 of the first cup 140. In one or more embodiments, the first absorbent material 146 is a non-woven material, a foam, or a sponge. In a specific embodiment, the foam is a polyurethane foam. In a specific 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, as Figure 3 and Figure 5 shown.

[0091] A first peelable seal 148 having a top web 149 is disposed on the mating surface of the first cup 140 to prevent the first absorbent material 146 from leaving the chamber 145. In the case where the first absorbent material 146 is properly inserted into the chamber 145 of the first cup 140, the first peelable seal 148 can be fixed to the mating surface of the open end 144 of the first cup 140 to seal the scrubbing device 130.

[0092] The second absorbent material 156 is disposed and received in the second chamber 155 of the second cup 150, and absorbs the second disinfectant 157 or antibacterial agent received within the second chamber 155 of the second cup 150. In one or more embodiments, the second absorbent material 156 is a nonwoven material, foam, or sponge. In a specific embodiment, the foam is polyurethane foam. In a specific 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, as Figures 2 - 6 shown.

[0093] A second peelable seal 158 having a top web 159 is disposed on the mating surface of the second cup 150 to prevent the second absorbent material 156 from leaving the second chamber 155. In the case where the second absorbent material 156 is properly inserted into the second chamber 155 of the second cup 150, the second peelable seal 158 can be secured to the mating surface of the open end 154 of the second cup 150 to seal the scrubbing device 130.

[0094] The first peelable seal 148 and the second peelable seal 158 minimize the risk of potential particulate ingress and also provide a substantially impermeable outer shell for the scrubbing device 130, providing a leak-proof and protective outer shell that protects the contents of the first absorbent material 146 and the second absorbent material 156 respectively contained within the first chamber 145 and the second chamber 155, and / or maintaining a sealed sterile environment. The first peelable seal 148 and the second peelable seal 158 provide sufficient sealing at a range of temperature, pressure, and humidity levels. Referring Figure 1 , the first peelable seal 148 and the second peelable seal 158 can be disposed 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 chambers of the respective first cup 140 and second cup 150.

[0095] The first peelable seal 148 and the second peelable seal 158 can be plastic-sealed aluminum and can be chemical-resistant, light-blocking, impermeable, or sterile. In one or more embodiments, the first peelable seal 148 and the second peelable seal 158 include an aluminum or multi-layer polymer film peel top. In a specific embodiment, the first peelable seal 148 and the second peelable seal 158 are heat-sealed or induction-sealed to the mating 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.

[0096] After inserting the connector into the open ends (144, 154) of the respective cups 140 and 150, the first absorbent material 146 and the second absorbent material 156, as well as the disinfectant or antibacterial agent, come into contact with the male luer connector, the female luer connector, and the hemodialysis connector.

[0097] In one or more embodiments, the female connector may be selected from the group consisting essentially of a needleless connector, a catheter luer connector, a stopcock, and a hemodialysis connector. In one or more embodiments, the male connector may be an intravenous tube end, a stopcock, or a male lock luer.

[0098] 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 copolymer, or any other moldable plastic material used in medical devices. In one or more embodiments, the first cup 140 and the second cup 150 comprise a polypropylene or polyethylene material.

[0099] To avoid having to use different types of disinfection caps to clean different types of connectors, the disinfection device 100 having the first cup 140 and the second cup 150 is compatible with and engages both the male luer connector and the female luer connector, thereby allowing the user to clean different types of connectors with a single device. Once the first cup 140 and the second cup 150 are mounted onto the female luer connector or the male luer connector, the female or male medical connector engages with the inner wall and contacts the first absorbent material 146 soaked with the disinfectant or antibacterial agent and enters the second absorbent material 156 when inserted into the first chamber 145 or the second chamber 155. Thus, the device of the present disclosure can disinfect both the male luer connector and the female luer connector, meeting the requirements of the current art.

[0100] Other aspects of the present disclosure relate to methods for disinfecting medical connectors and components. In one or more embodiments, a method for disinfecting a medical connector includes connecting a device according to one or more embodiments to the medical connector, wherein the connection includes frictionally engaging the inner wall surface once inserted into the chamber such that the medical connector contacts the absorbent material and the disinfectant or antibacterial agent.

[0101] In use, a clinician peels the top web 149 of the first peelable seal 148 from the first cup 140 before flushing an intravenous 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. Next, the clinician removes the scrubbing device 130 from the syringe barrel by applying torque to the entire assembly to screw the scrubbing device 130 off the locking Luer collar 119 at the distal end of the barrel 111, so as to allow the flush syringe to be attached to the intravenous catheter line to flush the intravenous catheter. The clinician places the first cup 140 on a sterile tray for subsequent use of the second cup, and the clinician threadedly engages the Luer lock collar on the distal end of the syringe barrel to the NFC to connect the NFC to the flush syringe. Thereafter, the clinician flushes the intravenous line. Next, after flushing the intravenous line, the clinician picks up the disassembled scrubbing device 130 and peels the top web 159 from the second cup 150 to expose the second absorbent material 156 soaked in the second disinfectant 157, and the clinician uses the second cup 150 to disinfect the NFC, wherein after the NFC connector is inserted into the second cup 150, the second absorbent material 156 soaked with the second disinfectant 157 or antimicrobial agent in the second cup 150 contacts the male Luer connector, the female Luer connector, and the hemodialysis connector. As in current practice, the clinician then administers the medication and uses the flush syringe to perform a second flush of the intravenous line to clear any medication remaining in the catheter and scrubs the seat with a disinfectant wipe or the scrubbing device. Thereafter, the clinician "locks" the intravenous line with a locking syringe filled with a heparin flush to help prevent blood clots from forming in the catheter. Finally, a new sterile cap is attached to the indwelling catheter seat.

[0102] In current practice where a clinician has only one scrubbing device attached to the flush syringe, an integrated scrubbing device is used before flushing. However, after the initial flush, there is no second scrubbing device attached to the syringe to disinfect the catheter seat. Embodiments of the present disclosure provide an additional scrubbing device integrated with the flush syringe (e.g., a flush syringe with two disinfection / scrubbing devices), which allows the clinician to disinfect the seat before and after flushing, thus complying with the SASH standard, as the clinician does not need to search for a disinfection device or skip connector disinfection before starting the next procedure (e.g., administering medication).

[0103] As described above, currently available products and SASH practices do not address any cleaning after the initial flushing procedure because disinfection ends after the first flush. Embodiments of the present invention include a first cup 140 and a second cup 150 that are independently packaged and both have absorbent materials (146, 156) carrying disinfectants, which have the advantage of implementing a two-step disinfection regime, providing additional protection for the patient through an additional cleaning step of disinfecting the seat or connection interface using IPA or a scrubbing device before administering the drug or locking solution, thereby further preventing the patient from potential infections.

[0104] When using the first cup 140, once connected to a female Luer connector or a male Luer connector, compression of the first absorbent material 146 towards the closed end 142 of the chamber 145 allows the connector to contact the first disinfectant 147 to disinfect the female Luer connector or the male Luer connector. Similarly, when using the second cup 150, once connected to a female Luer connector or a male Luer connector, compression of the second absorbent material 156 towards the closed end 152 of the second chamber 155 allows the connector to contact the second disinfectant 157 to disinfect the female Luer connector or the male Luer connector.

[0105] In one or more embodiments, the assembly includes a device of one or more embodiments connected to a medical connector. In one or more embodiments, the medical connector is selected from a male Luer connector, a female Luer connector, and a needleless connector.

[0106] Reference Figures 7 - 12 , a disinfection assembly 200 for connecting to a medical connector according to an exemplary embodiment of the present disclosure generally includes a syringe assembly 210 having a syringe barrel 211 with an elongated body 212 that defines a chamber 213 for retaining 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 therethrough that is in fluid communication with the chamber. The distal end 216 of the barrel further includes a locking Luer collar 219 that concentrically surrounds the tip 217. The locking Luer collar 219 has internal threads 220. The syringe assembly 210 further includes: a stopper 221 connected to an elongated plunger rod 222 that has a thumb press 223 at its proximal end; a scrubbing device 230 having a first cup 240 and a second cup 250. A bottom wall 231 spans the first cup 240.

[0107] Reference Figure 7 , the first cup 240 includes a one-piece body 241, a closed end 242, and has a length L extending from the closed end 242 to the open end 244 Can annular wall 243, and a peelable seal 248 having a top web 249, the annular wall defining a chamber 245 that houses a first absorbent material 246 and a first disinfectant 247 in a 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 an antibacterial agent. The open end 244 defines a mating surface for contact with the bottom surface 248B of the peelable seal 248.

[0108] Reference Figure 9 , a second cup 250 includes a one-piece body 251, a closed end 252, having a length L extending from the closed end 252 to an open end 254 C of an annular wall 253, the annular wall defining a second chamber 255 that houses 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 an antibacterial agent. The open end 254 defines a mating surface for contact with the top surface 248T of the peelable seal 248. Reference Figure 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.

[0109] The first cup 240 and the second cup 250 are arranged in a top-to-bottom orientation, and the first cup 240 and the second cup 250 are defined or bounded by a common peelable seal 248, wherein the open end 244 of the first cup 240 defines a mating surface for contact with the bottom surface 248B of the peelable seal 248, and the open end 254 of the second cup 250 defines a mating surface for contact with the top surface 248T of the peelable seal 248.

[0110] As Figures 7 to 12 shown, the syringe assembly 210 can be attached to the first cup 240 of the scrubbing device 230 by mechanical mating features. Once assembled together, the assembly of the syringe assembly 210 and the first cup 240 of the scrubbing device 230 can withstand axial forces, radial forces, and disassembly forces. To remove the first cup 240 of the scrubbing device 230 from the syringe barrel, the user should apply torque to the entire assembly to unscrew the scrubbing device 230 from the locking Luer collar 219 at the distal end of the barrel to allow attachment of a flush syringe to the intravenous 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 should unscrew and disengage from the barrel.

[0111] In Figures 7 - 12In one or more of the illustrated embodiments, 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 throughout the product's shelf life. The scrubbing device 230 of the present disclosure is assembled to the collar of the syringe via a mechanical or threaded connection, which facilitates high-speed automated assembly.

[0112] Compared to currently available separate rinse syringe and disinfection unit products, embodiments of the integrated disinfection unit 200 of the present disclosure provide ready access to the disinfection product with each rinse and easier manual operation during disinfection prior to rinsing.

[0113] In one or more embodiments, the disinfection unit 200 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 200 to be connected to a syringe. In an exemplary implementation of an embodiment of the present disclosure, the disinfection unit 200 includes an integrated thread or tab, and other features that allow the first cup 240 to be connected to a threaded fitting of a medical device through an interface in any and all combinations. In one or more embodiments, the syringe assembly 210 can be attached to the first cup 240 of the scrubbing device 230 using various methods, including but not limited to mechanical fasteners, snap fittings, and threaded connections. In one or more embodiments, a threaded connection is provided on the outer bottom surface of the disinfection unit 200 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 unit 200 to be connected to a syringe. In as Figures 9 - 11 In one or more of the illustrated embodiments, the bottom wall 231 of the first cup 240 of the scrubbing device 230 includes a threaded post 232 disposed in the center of the bottom wall 231 of the first cup 240, the threaded post corresponding to the internal threads 220 of a locking Luer-style collar 219 on the distal end of the syringe barrel 211.

[0114] When used on a needleless connector ("NFC"), the scrubbing device 230 can effect disinfection by integrating a first disinfectant 247 in a first absorbent material 246 disposed and contained within a first chamber 245 of a first cup 240 and integrating a second disinfectant 257 in a second absorbent material 256 disposed and contained within a second chamber 255 of a second cup 50. The first and second disinfectants (247, 257) can be directly included in the first and second chambers 245 and 255 and can be absorbed into the first and second absorbent materials 246 and 256 (e.g., sponge or foam material) respectively filling the chambers of the first and second cups 240 and 250. The scrubbing device 230 is designed to be compatible and interact with a variety of 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, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tertiary butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In 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, the first disinfectant 247 or the second disinfectant 257 is a fluid or a gel.

[0115] 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 non-woven material, foam, or sponge. In a specific embodiment, the foam is 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, as Figure 9 and Figure 11 shown.

[0116] A peelable seal 248 having a top web 249 is disposed on the mating surface of the cup 240 to prevent the first absorbent material 246 from leaving the chamber 245. In the case where the first absorbent material 246 is properly inserted into the chamber 245 of the first cup 240, the peelable seal 248 can be secured to the mating surface of the open end 244 of the first cup 240 to seal the scrubbing device 230.

[0117] The second absorbent material 256 is disposed and received in the second chamber 255 of the second cup 250, and absorbs the second disinfectant 257 or antibacterial agent received within the second chamber 255 of the second cup 250. In one or more embodiments, the second absorbent material 256 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 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 Figure 11 and Figure 12 as shown.

[0118] The peelable seal 248 minimizes the risk of potential particulate ingress and also provides a substantially impermeable outer shell for the scrubbing device 230, providing a leak-proof and protective outer shell that protects the contents of the first absorbent material 246 and the second absorbent material 256 respectively housed within the first chamber 245 and the second chamber 255, and / or maintains a sealed sterile environment. The peelable seal 248 provides sufficient sealing over a range of temperature, pressure, and humidity levels. Referring to the drawings, 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 leaving the respective chambers of the first cup 240 and the second cup 250.

[0119] The peelable seal 248 can be a plastic-sealed aluminum and can be chemical-resistant, light-blocking, impermeable, or sterile. In one or more embodiments, the peelable seal 248 includes an aluminum or multi-layer polymer film peel top. In a specific embodiment, the peelable seal 248 is heat-sealed or induction-sealed to the mating surface of the open ends (244, 254) of the cups (240, 250) to seal the scrubbing device 230. In one or more embodiments, the peelable seal 248 includes a moisture barrier.

[0120] After inserting the connectors into the open ends (244, 254) of the respective cups 240 and 250, the first absorbent material 246 and the second absorbent material 256, as well as the disinfectant or antibacterial agent, come into contact with the male luer connector, female luer connector, and hemodialysis connector.

[0121] In one or more embodiments, the female connector can be selected from the group consisting essentially of a needleless connector, catheter luer connector, stopcock, and hemodialysis connector. In one or more embodiments, the male connector can be an intravenous tube end, stopcock, or male lock luer.

[0122] 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 comprise a polypropylene or polyethylene material.

[0123] 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 with and engages both male and female Luer connectors, allowing a user to clean different types of connectors with a single device. Once the first cup 240 and the second cup 250 are installed onto a female or male Luer connector, the female or male medical connector engages with the inner wall after being inserted into the chamber 245 or 255 and contacts the first absorbent material 246 soaked with a disinfectant or antimicrobial agent and enters the second absorbent material 256. Thus, the device of the present disclosure can disinfect both male and female Luer connectors, meeting the current needs in the art.

[0124] Other aspects of the present disclosure relate to methods of disinfecting medical connectors and components. In one or more embodiments, a method of disinfecting a medical connector comprises connecting a device of one or more embodiments to the medical connector, wherein connecting comprises frictionally engaging an inner wall surface once inserted into the chamber such that the medical connector contacts the absorbent material and the disinfectant or antimicrobial agent.

[0125] In use, the clinician removes the second cup 250 from the scrubbing device 230 in a manner that peels the second cup 250 from the top web 249 of the peelable seal 248, leaving the peelable seal 248 on the first cup 240. The peelable seal 248 has a greater adhesion strength to the first cup 240 than to the second cup 250, thus allowing the second cup to be removed from the scrubbing device 230 while permitting the peelable seal 248 to remain on the first cup 240. The clinician then uses the second cup 250 to disinfect the NFC. After inserting the NFC 900 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 to the entire assembly to screw the scrubbing device 230 off the locking Luer collar 219 at the distal end of the barrel 211, to allow attachment of a flush syringe to the intravenous catheter line to flush the intravenous line. The clinician places the first cup 240 on a sterile tray for subsequent use of the first cup, and the clinician threads the Luer lock collar on the distal end of the syringe barrel onto the NFC to connect the NFC to the flush syringe. The clinician then flushes the intravenous line. Next, the clinician picks up the removed first cup 240 of the scrubbing device 230 and peels the top web 259 from the first cup 240 after flushing the intravenous line to expose the first absorbent material 246 soaked in the first disinfectant 247, and uses the first cup 240 to disinfect the NFC, wherein after inserting the NFC connector into the first cup 240, 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. As in current practice, the clinician then administers the medication and uses the flush syringe to perform a second flush of the intravenous line to clear any remaining medication from the catheter, and uses a disinfectant wipe or the scrubbing device to scrub the seat. The clinician then "locks" the intravenous line using a locking syringe filled with a heparin flush to help prevent blood clots from forming in the catheter. Finally, a new disinfected cap is attached to the indwelling catheter seat.

[0126] As described above, current products and SASH practices do not involve any cleaning after the initial flushing process because disinfection ends after the first flush. Embodiments of the present invention include a first cup 240 and a second cup 250 that are separately packaged and both have absorbent materials (246, 256) loaded with a disinfectant. The advantage is that a two-step disinfection regime is adopted, such that an additional cleaning step of disinfecting the seat or connection interface using IPA or a scrubbing device before administering the drug or locking solution provides additional protection to the patient, thereby further preventing the patient from potential infections.

[0127] When the first cup 240 is used, once connected to a female Luer connector or a male Luer connector, compression of the first absorbent material 246 towards the closed end 242 of the chamber 245 allows the connector to contact the first disinfectant 247 to disinfect the female Luer connector or the male Luer connector. Similarly, when the second cup 250 is used, once connected to a female Luer connector or a male Luer connector, compression of the second absorbent material 256 towards the closed end 252 of the second chamber 255 allows the connector to contact the second disinfectant 257 to disinfect the female Luer connector or the male Luer connector.

[0128] In one or more embodiments, the assembly includes a device of one or more embodiments connected to a medical connector. In one or more embodiments, the medical connector is selected from a male Luer connector, a female Luer connector, and a needleless connector.

[0129] Reference Figures 13 - 18 , a disinfection unit 300 for connecting to a medical connector according to an exemplary embodiment of the present disclosure generally further includes a syringe assembly 310 having a syringe barrel 311 with an elongated body 312 that defines a chamber 313 for retaining 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 therethrough that is in fluid communication with the chamber. The distal end 316 of the barrel further includes a locking Luer-style collar 319 that concentrically surrounds the tip 317. The locking Luer-style collar 319 has an internal thread 320. The syringe assembly 310 further includes: a stopper 321 connected to an elongated plunger rod 322 having a thumb press 323 at its proximal end; and a scrubbing device 330 having a first cup 340 and a second cup 350. A bottom wall 331 spans the first cup 340.

[0130] Reference Figures 15 - 17 , the first cup 340 includes: an integral body 341, a closed end 342, having a length L extending from the closed end 342 to the open end 344 CAn annular wall 343, and a first peelable seal 348 having a top web 349, the annular wall defining a first chamber 345 that houses a first absorbent material 346 and a first disinfectant 347 in a 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 an antibacterial agent. The open end 344 defines a mating surface for contact with the bottom surface 348B of the first peelable seal 348.

[0131] Reference Figures 15 - 17 , a second cup 350 includes: an integral body 351, a closed end 352, having a length L extending from the closed end 352 to an open end 354 C An annular wall 353, and a second peelable seal 358 having a top web 359, the annular wall defining a second chamber 355 that houses 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 an antibacterial agent. The open end 354 defines a mating surface for contact with the top surface 358T of the second peelable seal 358.

[0132] The open end 344 of the first cup 340 defines a mating surface for contact with the bottom surface 348B of the first peelable seal 348, and the open end 354 of the second cup 350 defines a mating surface for contact with the top surface 358T of the second peelable seal 358. The first cup 340 and the second cup 350 are arranged in a top-to-bottom orientation, and the top surfaces of the first peelable seals in the first cup 340 and the second cup 350 are bonded together with a low-adhesion strength adhesive 360 to the top surface of the second peelable seal.

[0133] As Figures 16 to 18 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 assembly of the syringe assembly 310 and the first cup 340 of the scrubbing device 330 can withstand axial forces, radial forces, and disassembly forces. To remove the first cup 340 of the scrubbing device 330 from the syringe barrel, the user applies torque to the entire assembly to screw the scrubbing device 330 out of the locking Luer collar 319 at the distal end of the barrel to allow attachment of a flush syringe to the intravenous catheter line. When torque is applied to either or both of the syringe or the first cup 340 of the scrubbing device 330, the scrubbing device 330 should unscrew from the barrel.

[0134] In Figures 16 - 18In 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 transportation, use, and throughout the product's shelf life. The scrubbing device 330 of the present disclosure is assembled with the collar of the syringe via a mechanical connection or a threaded connection, which facilitates high-speed automated assembly.

[0135] Compared to currently available separate rinse syringe and disinfection unit products, embodiments of the integrated disinfection unit 300 of the present disclosure provide ready accessibility of the disinfection product with each rinse and easier manual operation during disinfection prior to rinsing.

[0136] 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 implementation of an embodiment of the present disclosure, the disinfection unit 300 includes an integrated thread or tab, and other features that allow the first cup 340 to be interfaced with a threaded fitting of a medical device in any and all combinations. 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 fittings, and threaded connections. In one or more embodiments, a threaded connection is provided on the bottom outer surface of the disinfection unit 300, the threaded connection having 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 unit 300 to be connected to a syringe. In Figure 15 In one or more of the 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, the threaded post corresponding to the internal threads 320 of a locking Luer-style collar 319 on the distal end of the syringe barrel 311.

[0137] When used on a needleless connector ("NFC"), the scrubbing device 330 can effect 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 and second chambers 345 and 355 and can be absorbed into the first and second absorbent materials 346 and 356 (e.g., sponge or foam material) respectively filling the chambers of the first and second cups 340 and 350. The scrubbing device 330 is designed to be compatible with and interact with a variety of disinfectants. In one or more embodiments, the first disinfectant 347 or the second disinfectant 357 can include an alcohol or a variant of 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, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tertiary butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In 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.

[0138] The first absorbent material 346 absorbs the first disinfectant 347 or antimicrobial agent contained within the first chamber 345 of the first cup 340. In one or more embodiments, the first absorbent material 346 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 356 is in the form of a foam plug. In one or more embodiments, the second absorbent material 356 includes one or more slits, as Figure 14 and Figure 15 shown.

[0139] A first peelable seal 348 having a top web 349 is disposed on the mating surface of the first cup 340 to prevent the first absorbent material 346 from leaving the first chamber 345. In the case where the first absorbent material 346 is properly inserted into the first chamber 345 of the first cup 340, the first peelable seal 348 can be secured to the mating surface of the open end 344 of the first cup 340 to seal the scrubbing device 330.

[0140] A second peelable seal 358 with a top web 359 is disposed on the mating surface of the second cup 350 to prevent the second absorbent material 356 from leaving the second chamber 355. When the second absorbent material 356 is properly inserted into the second chamber 355 of the second cup 350, the second peelable seal 358 can be fixed to the mating surface of the open end 354 of the second cup 350 to seal the scrubbing device 330.

[0141] 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 within the second chamber 355 of the second cup 350. In one or more embodiments, the second absorbent material 356 is a nonwoven material, foam, or sponge. In a specific embodiment, the foam is polyurethane foam. In a specific 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, as Figure 14 and Figure 15 shown.

[0142] The first peelable seal 348 and the second peelable seal 358 minimize the risk of potential particulate ingress and also provide a substantially impermeable housing for the scrubbing device 330, providing a leak-proof and protective housing that protects the contents of the first absorbent material 346 and the second absorbent material 356 respectively contained within the first chamber 345 and the second chamber 355, and / or maintains a sealed sterile environment. The first peelable seal 348 and the second peelable seal 358 provide sufficient sealing over 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 chambers of the respective first cup 340 and second cup 350.

[0143] The first peelable seal 348 and the second peelable seal 358 can be plastic-sealed aluminum and can be chemical-resistant, light-blocking, impermeable, or sterile. In one or more embodiments, the first peelable seal 348 and the second peelable seal 358 include an aluminum or multi-layer polymer film peel top. In a specific embodiment, the first peelable seal 348 and the second peelable seal 358 are heat-sealed or induction-sealed to the mating surface of the open ends (344, 354) of the cups (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.

[0144] After inserting the connector into the open ends (344, 354) of the respective cups 340 and 350, the first absorbent material 346 and the second absorbent material 356, as well as the disinfectant or antibacterial agent, come into contact with the male luer connector, the female luer connector, and the hemodialysis connector.

[0145] In one or more embodiments, the female connector can be selected from the group consisting essentially 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 lock luer.

[0146] 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 comprise a polypropylene or polyethylene material.

[0147] 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 with and engages both the male luer connector and the female luer connector, thereby allowing the user to clean different types of connectors with a single device. Once the first cup 340 and the second cup 350 are mounted onto the female luer connector or the male luer connector, the female or male medical connector comes into contact with and engages the inner wall and contacts the first absorbent material 346 soaked with the disinfectant or antibacterial agent and enters the second absorbent material 356 after being inserted into the first chamber 345 or the second chamber 355. Thus, 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.

[0148] Other aspects of the present disclosure relate to methods for disinfecting medical connectors and components. In one or more embodiments, a method of disinfecting a medical connector includes connecting a device of one or more embodiments to the medical connector, wherein the connecting includes frictionally engaging the inner wall surface once inserted into the chamber such that the medical connector contacts the absorbent material and the disinfectant or antibacterial agent.

[0149] In use, the clinician removes the second cup 350 from the scrubbing device 330 in a manner that peels the second cup 350 away from the first cup 340 such that the first peelable seal 348 remains on the first cup 340 and the second peelable seal 358 remains on the second cup 350. The adhesion strength of the first peelable seal 348 to the first cup 340 and the adhesion strength of the second peelable seal 358 to the second cup 350 are each greater than the adhesion strength of the low adhesion strength adhesive that bonds the top surface of the first peelable seal to the top surface of the second peelable seal, thereby allowing the second cup 350 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 340. Then, the clinician uses the first cup 340 to disinfect the NFC prior to flushing the intravenous line. Once 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 to screw the scrubbing device 330 off of the locking Luer collar 319 at the distal end of the syringe barrel 311 to allow an irrigation syringe to be attached to the intravenous catheter line to flush the intravenous line. When torque is applied to either or both of the syringe or the first cup 340, the first cup 340 of the scrubbing device 330 should unscrew and disengage from the barrel. Then, the clinician threadedly engages the Luer lock collar on the distal end of the syringe barrel to the NFC to connect the NFC to the irrigation syringe. After flushing, the clinician picks up the detached second cup 350 of the scrubbing device 330 and peels the top web 359 from the second cup 350 after flushing the intravenous line to expose the second absorbent material 356 soaked in the second disinfectant 357, and disinfects the NFC using the second cup 350 by contacting the male Luer connector, female Luer connector, and hemodialysis connector after the NFC connector is inserted into the second cup 350 having the second absorbent material 356 soaked in the second disinfectant 357. As in current practice, the clinician then administers medication and uses the irrigation syringe to perform a second flush of the intravenous line to clear any medication remaining in your catheter, and scrubs the seat using a disinfectant wipe or the scrubbing device. Then, the clinician "locks" the intravenous line with a locking syringe filled with a heparin flush to help prevent blood clots from forming in the catheter. Finally, a new disinfected cap is attached to the indwelling catheter seat.

[0150] As described above, current products and SASH practices do not address any cleaning after the initial flushing process because disinfection ends after the first flush. Embodiments of the present invention include a first cup 340 and a second cup 350, both independently packaged and each having absorbent material (346, 356) loaded with a disinfectant. The advantage is that a two-step disinfection regime is employed, which provides additional protection for the patient through an additional cleaning step of disinfecting the seat or connection interface using IPA or a scrubbing device before administering the drug or locking solution, thereby further preventing potential infection of the patient.

[0151] When using the first cup 340, once connected to a female Luer connector or a male Luer connector, compression of the first absorbent material 346 towards the closed end 342 of the first chamber 345 allows the connector to contact the first disinfectant 347 to disinfect the female Luer connector or the male Luer connector. Similarly, when using the second cup 350, once connected to a female Luer connector or a male Luer connector, compression of the second absorbent material 356 towards the closed end 352 of the second chamber 355 allows the connector to contact the second disinfectant 357 to disinfect the female Luer connector or the male Luer connector.

[0152] In one or more embodiments, the assembly includes a device of one or more embodiments connected to a medical connector. In one or more embodiments, the medical connector is selected from a male Luer connector, a female Luer connector, and a needleless connector.

[0153] Reference Figures 19 - 23 , a disinfection unit 400 for connecting to a medical connector according to an exemplary embodiment of the present disclosure generally further includes a syringe assembly 410 having a syringe barrel 411 with an elongated body 412 that defines a chamber 413 for retaining 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 therethrough and in fluid communication with the chamber. The distal end 416 of the barrel further includes a locking Luer-style collar 419 concentrically surrounding the tip 417. The locking Luer-style collar 419 has internal threads 420. The syringe assembly 410 further includes: a stopper 421 connected to an elongated plunger rod 422 having a thumb press 423 at its proximal end; and a scrubbing device 430 having a first cup 440 and a second cup 450. A bottom wall 431 spans the first cup 440.

[0154] Reference Figure 22 , the first cup 440 includes a one-piece body 441, a closed end 442, and has a length L extending from the closed end 442 to the open end 444 Ca first peelable seal 448 of the annular wall 443 and 449 having a top web, the annular wall defining a first chamber 445 that houses a first absorbent material 446 and a first disinfectant 447 in the first cup 440. The peelable seal 448 has a bottom surface 448B and a top surface 448T. The first absorbent material 446 is soaked in the first disinfectant 447 or an antibacterial agent. The open end 444 defines a mating surface for contact with the bottom surface 448B of the first peelable seal 448.

[0155] The open end 444 of the first cup 440 defines a mating surface for contact with the bottom surface 448B of the first peelable seal 448, and the open end 454 of the second cup 450 defines a mating surface for contact with the top surface 458T of the second peelable seal 458.

[0156] As Figure 23 shown, the syringe assembly 410 can be attached to the first cup 440 of the scrubbing device 430 by mechanical mating features. Once assembled together, the assembly of the syringe assembly 410 and the first cup 440 of the scrubbing device 430 can withstand axial forces, radial forces, and disassembly forces. To remove the first cup 440 of the scrubbing device 430 from the syringe barrel, the user should apply torque to the entire assembly to screw the scrubbing device 430 out of the locking Luer collar 419 at the distal end of the barrel to allow attachment of a flush syringe to the intravenous catheter line. When torque is applied to either or both of the syringe or the first cup 440 of the scrubbing device 430, the scrubbing device 430 should unscrew from the barrel.

[0157] Reference Figure 22 , the second cup 450 includes an integral body 451, a closed end 452, an annular wall 453 having a length L extending from the closed end 452 to the open end 454 C and a second peelable seal 458 having a top web 459, the annular wall defining a second chamber 455 that houses a second absorbent material 456 and a second disinfectant 457 in the second cup 450, the closed end 452 of the annular wall 453 having a boss extending from the closed end 452. The second absorbent material 456 is soaked in the second disinfectant 457 or an antibacterial agent. The open end 454 defines a mating surface for contact with the top surface 448T of the second peelable seal 458.

[0158] As Figures 20 to 23As shown, the second cup and the syringe assembly are interlocked by an interference fit or snap fit between the thumb press portion of the syringe and the boss of the second cup. A boss / wedge portion may be disposed at the closed end of the annular wall of the second cup to provide a snap connection with the thumb press portion. The inner surface of the top wall disposed at the closed end of the annular wall of the second cup may have a recess into which the boss / wedge portion of the insert may be inserted.

[0159] In Figures 20 - 23 In one or more of the embodiments shown, 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 throughout the product's shelf life. The scrubbing device 430 of the present disclosure is assembled with the collar of the syringe via a mechanical connection or a threaded connection, which facilitates high-speed automated assembly.

[0160] Compared to currently available separate rinse syringe and disinfection unit products, embodiments of the integrated disinfection unit 400 of the present disclosure provide easy access to the disinfection product with each rinse and easier manual operation during disinfection prior to rinsing.

[0161] 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, for example, a Luer threaded connection, to allow the assembled disinfection unit 400 to be connected to a syringe. In an exemplary implementation of an embodiment of the present disclosure, the disinfection unit 400 includes an integrated thread or tab, and other features that allow the first cup 440 of the disinfection unit to be connected to the threaded fitting of the medical device through an interface in any and all combinations. In one or more embodiments, the syringe assembly 410 may be attached to the first cup 440 of the scrubbing device 430 using various methods, including but not limited to mechanical fasteners, snap fittings, and threaded connections. In one or more embodiments, a threaded connection portion is provided on the outer bottom surface of the first cup of the disinfection unit 400, the threaded connection portion having 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 unit 400 to be connected to the syringe. In as Figure 21 In one or more of the 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, the threaded post corresponding to the internal threads 420 of the locking Luer-type collar 419 on the distal end of the syringe barrel 411. As Figure 23As shown, the second cup and the syringe assembly are interlocked by an interference fit or snap fit between the thumb press portion of the syringe and the boss of the second cup. A boss / wedge portion may be disposed at the closed end of the annular wall of the second cup to provide a snap connection with the thumb press portion. The inner surface of the top wall disposed at the closed end of the annular wall of the second cup may have a recess into which the peripheral boss 460 of the insert may be inserted.

[0162] The closed end defines an end face that includes a peripheral boss 460 extending radially outward from the annular wall.

[0163] The second cup is adapted to snap fit onto the thumb press portion of the plunger rod and is opposite the Luer tip. Refer to Figure 23 , in one or more embodiments, the second cup may be connected to the thumb press portion, wherein a rim is provided on the peripheral boss and radially inward to form a lip or rim. The inner surface of the peripheral boss in the inner annular wall surface at the closed end of the second cup includes at least two or more mating protrusions 470 that allow the thumb press portion to mate with the second cup via a snap fit connection. In one or more embodiments, the snap fit connection includes a protruding edge and a snap region. The protruding edge may be provided on the inner surface of the peripheral side wall of the peripheral boss or on the inner annular wall surface at the closed end of the second cup, and a corresponding snap region is provided on the surface opposite the protruding edge to allow the protruding edge and the snap region to be interlocked.

[0164] 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 portion of the present disclosure, the inner annular wall surface at the closed end of the second cup 450 has locking tabs 470 that are annular and more robust in structure and easier to mold.

[0165] In one or more embodiments, the clip is configured as a locking mechanism, whereby the unidirectionally flexed clip requires a relatively low axial force to assemble and generates significant locking strength. As the second cup and the thumb press portion are assembled together, the clips flex inward until they enter the thumb press portion of the plunger rod. Once contact is formed between the clip and the thumb press portion, the clip springs or deflects outward, thereby creating a mating between the thumb press portion and the second cup 450.

[0166] Specifically, during the assembly of the second cup 450 and the thumb press portion 423, the closed end of the second cup 450 is inserted into the thumb press portion 423. The clip flexes inwardly towards the annular wall of the second cup 450. Once the clip has moved past and away from the thumb press portion 423, the clip springs outwardly, thereby creating a permanent mating between the two components without the use of an adhesive. Once the assembly is complete, the mechanical mating prevents the removal of the second cup 450 from the thumb press portion 423 by pulling the components away from each other.

[0167] As the second cup and the thumb press portion are assembled together, the bottom end of the cup is oriented to face the top end of the thumb press portion. During assembly, the second cup is pressed onto the thumb press portion, and its peripheral edge causes the protrusions on the inner annular wall surface at the closed end of the second cup 450 to expand outwardly. Once the protrusions of the cup have passed over the peripheral edge of the thumb press portion, the protrusions snap inwardly and lock the cup onto the thumb press portion.

[0168] The second cup may also include a skirt extending away from the closed end of the second cup 450. The skirt consists of a lip, and the lip is located on the side wall of the skirt with its x-axis facing the second cup. Generally, as the cup and the thumb press portion are assembled together, the outer skirts of the second cup flex outwardly until they engage the beveled edges on the outer wall surface of the thumb press portion. Once the lip has passed over the beveled edge, the outer skirts snap inwardly, thereby creating a lock between the thumb press portion and the second cup.

[0169] When used on a needleless connector (“NFC”), the scrubbing device 430 can effect disinfection by integrating a first disinfectant 447 into a first absorbent material 446 disposed and contained within a first chamber 445 of a first cup 440 and integrating a second disinfectant 457 into a second absorbent material 456 disposed and contained within a second chamber 455 of a second cup 450. The first and second disinfectants (447, 457) can be directly included within the first and second chambers 445 and 455 and can be absorbed respectively into the first and second absorbent materials 446 and 456 (e.g., sponge or foam material) that respectively fill the chambers of the first and second cups 440 and 450. The scrubbing device 430 is designed to be compatible with and 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, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tertiary butyl hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In 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.

[0170] The first absorbent material 446 absorbs the first disinfectant 447 contained within 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 first absorbent material 446 is in the form of a foam plug. In one or more embodiments, the first absorbent material 446 includes one or more slits, as Figure 21 and Figure 23 shown.

[0171] A first peelable seal 448 having a top web 449 is disposed on the mating surface of the first cup 440 to prevent the first absorbent material 446 from leaving the first chamber 445. In the event that the first absorbent material 446 is properly inserted into the first chamber 445 of the first cup 440, the first peelable seal 448 can be secured to the mating surface of the open end 444 of the first cup 440 to seal the scrubbing device 430.

[0172] A second peelable seal 458 having a top web 459 is disposed on the mating 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 mating surface of the open end 454 of the second cup 450 to seal the scrubbing device 430.

[0173] The second absorbent material 456 is disposed and contained within the second chamber 455 of the second cup 450 and absorbs a second disinfectant 457 contained within the second chamber 455 of the second cup 450. In one or more embodiments, the second absorbent material 456 is a non-woven material, foam, or sponge. In a particular 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, as Figure 21 and Figure 23 shown.

[0174] The first peelable seal 448 and the second peelable seal 458 minimize the risk of potential particulate ingress and also provide a substantially impermeable outer shell for the scrubbing device 430, providing a leak-proof and protective outer shell that protects the contents of the first absorbent material 446 and the second absorbent material 456 respectively contained within the first chamber 445 and the second chamber 455, and / or maintains a sealed sterile environment. The first peelable seal 448 and the second peelable seal 458 provide adequate sealing over 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 second cup 450.

[0175] 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 include an aluminum or multi-layer polymer film peel top. In a particular embodiment, the first peelable seal 448 and the second peelable seal 458 are heat-sealed or induction-sealed to the mating surface of the open ends (444, 454) of the cups (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.

[0176] After inserting the connector into the open ends (444, 454) of the respective cups 440 and 450, the first absorbent material 446, the second absorbent material 456, and the disinfectant are in contact with the male luer connector, the female luer connector, and the hemodialysis connector.

[0177] In one or more embodiments, the female connector can be selected from the group consisting essentially 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 lock luer.

[0178] 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 comprise a polypropylene or polyethylene material.

[0179] 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 with and engages both the male luer connector and the female luer connector, thereby allowing the user to clean different types of connectors using a single device. Once the first cup 440 and the second cup 450 are mounted onto the female luer connector or the male luer connector, the female or male medical connector engages and contacts the inner wall and the first absorbent material 446 soaked with the disinfectant and enters the second absorbent material 456 when inserted into the first chamber 445 or the second chamber 455. Thus, 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.

[0180] Other aspects of the present disclosure relate to methods of disinfecting medical connectors and components. In one or more embodiments, a method of disinfecting a medical connector includes connecting a device of one or more embodiments to the medical connector, wherein the connecting includes frictionally engaging the inner wall surface once inserted into the chamber such that the medical connector contacts the absorbent material and the disinfectant.

[0181] In use, the clinician breaks off and removes the second cup from the syringe assembly and places the second cup 450 on a sterile tray for subsequent disinfection of the NFC using the sealed second cup prior to flushing. As discussed above, the snap feature in the bottom side of the second cup is disengaged from the thumb press of the plunger of the syringe. The clinician peels off the top web 449 of the first peelable seal 448 from the first cup 440. The clinician then disinfects the NFC using the first cup 440 prior to flushing the intravenous line. Once the NFC is inserted into the first cup 440, the first absorbent material 446 soaked with the disinfectant 447 comes into contact with the NFC. Next, the clinician removes the first cup 440 of the scrubbing device 430 from the syringe barrel 411 by applying torque to the entire assembly to screw the scrubbing device 430 out of the locking Luer collar 419 at the distal end of the syringe barrel to allow the flush syringe to be attached to the intravenous catheter line to flush the intravenous catheter line. When torque is applied to either or both of the syringe or the first cup 440, the first cup 440 of the scrubbing device 430 should unscrew and disengage from the barrel. The clinician then threadedly engages the Luer lock collar on the distal end of the syringe barrel to the NFC to connect the NFC to the flush 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 intravenous line to expose the second absorbent material 456 soaked in the second disinfectant 457, and disinfects the NFC using the second cup 450 by bringing the male Luer connector, female Luer connector, and hemodialysis connector into contact with the second absorbent material 456 soaked in the second disinfectant 457 after the NFC connector is inserted into the second cup 450. As in current practice, the clinician then administers the medication and performs a second flush of the intravenous line using the flush syringe to clear the residual medication in your catheter and scrubs the seat using a disinfectant wipe or scrubbing device. The clinician then "locks" the intravenous line with a locking syringe filled with a heparin flush to help prevent blood clots from forming in the catheter. Finally, a new disinfection cap is attached to the indwelling catheter seat.

[0182] As described above, current products and SASH practices do not address any cleaning after the initial flushing process as disinfection ends after the first flush. Embodiments of the present invention include both a first cup 440 and a second cup 450 in separate packages each having an absorbent material (446, 456) loaded with a disinfectant, the benefit being a two-step disinfection measure that provides additional protection to the patient by an additional cleaning step of disinfecting the seat or connection interface using IPA or a scrubbing device prior to administering the medication or locking solution, thereby further preventing potential infection of the patient.

[0183] When using the first cup 440, once connected to a female Luer connector or a 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 Luer connector or the male Luer connector. Similarly, when using the second cup 450, once connected to a female Luer connector or a 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 Luer connector or the male Luer connector.

[0184] In one or more embodiments, the assembly includes a device of one or more embodiments connected to a medical connector. In one or more embodiments, the medical connector is selected from a male Luer connector, a female Luer connector, and a needleless connector.

[0185] In another alternative embodiment, referring to Figures 24 to 29 , a disinfection unit 500 for connecting to a medical connector includes a syringe assembly 510 having a syringe barrel 511 with an elongated body 512 that defines a chamber 513 for retaining 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 passageway 518 therethrough in fluid communication with the chamber. The distal end 516 of the barrel also includes a locking Luer collar 519 concentrically surrounding the tip 517. The locking Luer collar 519 has an internal thread 520. The syringe assembly 510 further includes a stopper 521 connected to an elongated plunger rod 522 having a thumb press 523 at its proximal end.

[0186] Referring to Figures 24 to 29 , a 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.

[0187] Referring to Figures 24 to 29 , the first cup 540 includes an integral body 541, a closed end 542, an annular wall 543 having a length L extending from the closed end 542 to an open end 544 C , and a first peelable seal 548. The annular wall defines a first chamber 545 that houses a first absorbent material 546 and a first disinfectant 547 within the first cup 540. The first absorbent material 546 is soaked in the first disinfectant 547. The open end 544 defines an engagement surface for contact with the first peelable seal 548 having a top web 549.

[0188] Referring to Figures 24 to 29, the second cup 550 includes an integral body 551, a closed end 552, an annular wall 553 having a length L extending from the closed end 552 to an open end 554 C and a second peelable seal 558 having a top web 559, the annular wall defining a chamber 555 that houses a second absorbent material 556 and a second disinfectant 557 within the second cup 550. The second absorbent material 556 is soaked in the second disinfectant solution 557. The open end 554 defines a mating surface for contact with the second peelable seal 558.

[0189] The first cup 540 and the second cup 550 are disposed in a side-by-side orientation and are defined by a female T-slot 570 on the first cup 540 that engages 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 feature 570 on the second cup 550 that engages a male T-nut fastener 580 on the first cup 540. The stops 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, upon a 90° rotation, the oval shoulder aligns within the upper portion of the T-slot and is locked in the T-slot by a secure connection. 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 towards the user or grasp and pull the top portion of the first cup towards 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 scrubbing device 530 from the syringe barrel, the user should apply a torque to the entire assembly to screw the scrubbing device 530 off the locking Luer collar 519 at the distal end of the barrel to allow attachment of a flush syringe to the intravenous catheter line. When a torque is applied to either or both of the syringe or the scrubbing device 530, the scrubbing device 530 should unscrew from the barrel.

[0190] As Figures 26 to 29 shown, the syringe assembly 510 can be attached to a scrubbing device 330 having mechanical mating features. Once assembled together, the assembly formed by the syringe assembly 510 and the scrubbing device 530 can withstand axial forces, radial forces, and disassembly forces. To remove the scrubbing device 530 from the syringe barrel, the user should apply a torque to the entire assembly to screw the scrubbing device 530 off the locking Luer collar 519 at the distal end of the barrel to allow attachment of a flush syringe to the IV catheter line. When a torque is applied to either or both of the syringe or the scrubbing device 530, the scrubbing device 530 should unscrew from the barrel.

[0191] In the prior art, the lower side of a "carriage" is employed below the position of the disinfection unit, so that the user can easily disassemble the carriage during normal use. In contrast, the assembly of the scrubbing device 530 of the present disclosure with the collar of the syringe does not require a separate "carriage" or other device to assemble these devices together.

[0192] In Figures 26 - 29 one or more of the illustrated embodiments, mechanical mating and assembly features ensure that the devices can be assembled in an automated process and ensure the integrity of the devices during transportation, use, and the product's shelf life. The scrubbing device 530 of the present disclosure is assembled with the collar of the syringe via a mechanical connection or a threaded connection, which facilitates high-speed automated assembly.

[0193] Compared with currently available separate irrigation syringe and disinfection unit products, the embodiments of the integrated disinfection unit of the present disclosure provide easy accessibility of the disinfection product during each irrigation and easier manual operation during the disinfection prior to irrigation.

[0194] As Figures 26 to 29 illustrated, in one or more embodiments, the disinfection unit 500 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, for example, a Luer threaded connection, to allow the assembled disinfection unit 500 to be connected to the syringe. In an exemplary implementation of an embodiment of the present disclosure, the disinfection unit 500 includes an integrated thread or tab, and other features that allow it to be connected through an interface with a threaded fitting of a medical device in any and all combinations. In one or more embodiments, the syringe assembly 510 can be attached to the scrubbing device 530 using various methods, including but not limited to mechanical fasteners, snap fittings, and threaded connections. In one or more embodiments, a threaded connection is provided on the bottom outer surface of the disinfection unit 500, the threaded connection having 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 unit 500 to be connected to the syringe. In one or more embodiments, as Figure 1 illustrated, the bottom wall 531 of the scrubbing device 530 includes a threaded post 532 disposed at the center of the bottom wall 531 adjacent to the common partition wall 560, the threaded post corresponding to the internal thread 520 of the locking Luer-type collar 519 on the distal end of the syringe barrel 511.

[0195] When used on a needleless connector (“NFC”), the scrubbing device 530 can effect disinfection by integrating a first disinfectant 547 into a first absorbent material 546 disposed and contained within a first chamber 545 of a first cup 540 and integrating a second disinfectant 557 into a second absorbent material 556 disposed and contained within a second chamber 555 of a second cup 550. The first and second disinfectants (547, 557) can be directly included within the first and second chambers 545 and 555 and can be absorbed into the first and second absorbent materials 546 and 556 (e.g., sponge or foam material) that respectively fill the chambers of the first and second cups 540 and 550. The scrubbing device 530 is designed to be compatible with and interact with a variety of disinfectants. In one or more embodiments, the first disinfectant 547 or the second disinfectant 557 can include an alcohol or a variant of 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, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tertiary butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In 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.

[0196] The first absorbent material 546 absorbs the first disinfectant 547 contained within the first chamber 545 of the first cup 540. In one or more embodiments, the first absorbent material 546 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 556 is in the form of a foam plug. In one or more embodiments, the second absorbent material 556 includes one or more slits, as Figure 26 and Figure 28 shown.

[0197] A first peelable seal 548 having a top web 549 is disposed on the mating surface of the first cup 540 to prevent the first absorbent material 546 from leaving the chamber 545. In the case where the first absorbent material 546 is properly inserted into the chamber 545 of the first cup 540, the first peelable seal 548 can be secured to the mating surface of the open end 544 of the first cup 540 to seal the scrubbing device 530.

[0198] A second absorbent material 556 is disposed and contained within a chamber 555 of a second cup 550 and absorbs a second disinfectant 557 contained within the chamber 555 of the second cup 550. In one or more embodiments, the second absorbent material 556 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 Figure 26 and Figure 28 shown

[0199] A second peelable seal 558 having a top web 559 is disposed on a mating surface of the second cup 550 to prevent the second absorbent material 546 from leaving the chamber 555. In the case where the second absorbent material 546 is properly inserted into the chamber 555 of the second cup 550, the second peelable seal 558 can be secured to a mating surface of an open end 554 of the second cup 550 to seal the scrubbing device 530.

[0200] The first peelable seal 548 and the second peelable seal 558 minimize the risk of potential particulate ingress and also provide a substantially impermeable outer shell for the scrubbing device 530, providing a leak-proof and protective outer shell that protects the contents of the first absorbent material 546 and the second absorbent material 546 contained within the first chamber 545 and the second chamber 555, respectively, and / or maintains a sealed sterile environment. The first peelable seal 548 and the second peelable seal 558 provide a sufficient seal over a range of temperature, pressure, and humidity levels. Referring Figure 1 , the first peelable seal 548 and the second peelable seal 558 can be disposed on 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 respective first cup 540 and second cup 550.

[0201] 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 include an aluminum or multi-layer polymer film peel top. In a specific embodiment, the first peelable seal 548 and the second peelable seal 558 are heat-sealed or induction-sealed to a mating surface of an 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.

[0202] After inserting the connector into the open ends (544, 554) of the respective cups 540 and 550, the first absorbent material 546 and the second absorbent material 556, as well as the disinfectant, come into contact with the male luer connector, the female luer connector, and the hemodialysis connector.

[0203] In one or more embodiments, the female connector can be selected from the group consisting essentially 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 lock luer.

[0204] 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 comprise a polypropylene or polyethylene material.

[0205] 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 with and engageable with both male luer connectors and female luer connectors, thus allowing the user to clean different types of connectors using a single device. Once the first cup 540 and the second cup 550 are mounted onto a female luer connector or a male luer connector, the female or male medical connector comes into contact with and engages the inner wall and the first absorbent material 546 and the second absorbent material 556 soaked with the disinfectant after being inserted into the chambers 545 or 555. Accordingly, the device of the present disclosure can disinfect both male luer connectors and female luer connectors, thus meeting the current needs in the art.

[0206] Other aspects of the present disclosure relate to methods for disinfecting medical connectors and components. In one or more embodiments, a method of disinfecting a medical connector includes connecting a device of one or more embodiments to the medical connector, wherein connecting includes frictionally engaging the inner wall surface once inserted into the chamber such that the medical connector contacts the absorbent material and the disinfectant.

[0207] In use, a 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 disinfect a needleless connector ("NFC") using the sealed first cup prior to flushing. Then, prior to flushing the intravenous line, the clinician peels the top web 559 of the second peelable seal 558 from the second cup 550. Then, the clinician disinfects the NFC using the second cup 550. Once 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, or a hemodialysis connector. Next, the clinician removes the second cup 550 of the scrubbing device 530 from the syringe barrel by applying torque to the entire assembly to screw the second cup 550 of the scrubbing device 530 out of the locking luer collar 519 at the distal end of the syringe barrel 511 to allow attachment of a flush syringe to the intravenous catheter line to flush the intravenous line. The clinician threadedly engages the luer lock collar on the distal end of the syringe barrel to the NFC to connect the NFC to the flush syringe. Then, the clinician flushes the intravenous line. Next, the clinician picks up the disassembled first cup 540 of the scrubbing device 530 and peels the top web 549 from the first cup 540 after flushing the intravenous line to expose the first absorbent material 546 soaked in the first disinfectant 547, and disinfects the NFC using the first cup 540, wherein after the NFC connector is inserted into the first cup 540, 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 the medication and uses the flush syringe to perform a second flush of the intravenous line to clear the medication remaining in your catheter, and scrubs the seat using a disinfectant wipe or the scrubbing device. Then, the clinician "locks" the intravenous line with a locking syringe filled with a heparin flush to help prevent blood clots from forming in the catheter. Finally, a new disinfected cap is attached to the indwelling catheter seat.

[0208] As described above, current products and SASH practices do not address any cleaning after the initial flushing process, as disinfection ends after the first flush. Embodiments of the present invention include both a first cup 540 and a second cup 550 that are independently packaged and have absorbent materials (546, 546) loaded with disinfectant, the benefit being a two-step disinfection measure that provides additional protection for the patient by an additional cleaning step of disinfecting the seat or connection interface using IPA or the scrubbing device prior to administering the medication or locking solution, thereby further preventing potential infection of the patient.

[0209] When using the first cup 540, once connected to a female Luer connector or a male Luer connector, compression of the first absorbent material 546 toward the closed end 542 of the first chamber 545 allows the connector to contact the first disinfectant 547 to disinfect the female Luer connector or the male Luer connector. Similarly, when using the second cup 550, once connected to a female Luer connector or a male Luer connector, compression of the second absorbent material 556 toward the closed end 552 of the second chamber 555 allows the connector to contact the second disinfectant 557 to disinfect the female Luer connector or the male Luer connector.

[0210] In one or more embodiments, the assembly includes a device of one or more embodiments connected to a medical connector. In one or more embodiments, the medical connector is selected from a male Luer connector, a female Luer connector, and a needleless connector.

[0211] In another alternative embodiment, referring to Figure 30 , the disinfection unit 600 includes a flushing syringe assembly 610 having a syringe barrel 611 with an elongated body 612 that defines a chamber 613 for retaining fluid. The syringe barrel 611 includes an open proximal end 614 having a flange 615 and a distal end 616 including a tip 617 that has a passageway 518 therethrough and in fluid communication with the chamber. The distal end 616 of the barrel also includes a locking Luer-style collar 619 that concentrically surrounds the tip 617. The locking Luer-style collar 619 has internal threads. The syringe assembly 610 also includes a stopper 621 connected to an elongated plunger rod 622 that has a thumb press 623 at its proximal end. A tip cap 680 is screwed onto the distal end of the barrel to provide closure integrity for the syringe contents throughout the shelf life and is removed by the user prior to flushing administration. The syringe assembly 610 also includes a stopper 631 connected to an elongated plunger rod 632 that has a flange 634 at its proximal end.

[0212] 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 an adhesive or threaded through a small hole 670 provided in 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 each end of the cord that is respectively attached to the two individually packaged disinfectant-loaded scrubbing pads (650, 660). Further, the cord may be wound around a groove, notch or hole in the flange so that the user can easily grasp the two individually packaged disinfectant-loaded scrubbing pads (650, 660). The two individually packaged disinfectant-loaded scrubbing pads (650, 660) provided enforce a disinfection solution (which might otherwise not be followed) and provide additional protection to the patient by including an additional cleaning step of disinfecting the seat or connection interface using IPA or a scrubbing device before administering the medication or locking solution, thereby further preventing the patient from potential infections.

[0213] In use, one of the two individually packaged disinfectant-loaded scrubbing pads (650, 660) is required to disinfect the catheter to which the flush syringe is connected. In use, the clinician removes the first of the two individually packaged disinfectant-loaded scrubbing pads (650), and the clinician places the first individually packaged disinfectant-loaded scrubbing pad (650) on a sterile tray for subsequent use before flushing. Then, the clinician opens the individually packaged disinfectant-loaded scrubbing pad (650) before flushing the intravenous line. Then, the clinician uses the individually packaged disinfectant-loaded scrubbing pad (650) to contact and enter the NFC into the individually packaged disinfectant-loaded scrubbing pad (650) to disinfect the NFC. In one or more embodiments, the NFC may 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 onto the NFC to connect the NFC to the flush syringe. Subsequently, the clinician flushes the intravenous line. Next, the clinician opens the separately packaged disinfectant-loaded scrubbing pad (660) and contacts the male Luer connector, the female Luer connector or the hemodialysis connector.

[0214] As described above, current products and SASH practices do not involve any cleaning after the initial flushing process, as disinfection ends after the first flush. Embodiments of the present invention include two separately packaged scrubbing pads (650, 660) loaded with a disinfectant, which have the benefit of a two-step disinfection measure that provides additional protection to the patient by including an additional cleaning step of disinfecting the seat or connection interface using IPA or a scrubbing device before administering the drug or locking solution, thereby further preventing the patient from potential infections.

[0215] In another alternative embodiment, referring to Figure 31 , the disinfection unit 700 includes a flushing syringe assembly 710 having a syringe barrel 711, the syringe barrel having an elongated body 712 defining a chamber 713 for retaining 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 passageway 718 therethrough that is in fluid communication with the chamber. The distal end 716 of the barrel also includes a locking Luer collar 719 concentrically surrounding the tip 717. The locking Luer collar 719 has internal threads 720. The syringe assembly 710 also includes a plunger 721 connected to an elongated plunger rod 722, the elongated plunger rod having a thumb press 723 at its proximal end. A tip cap 780 is screwed onto the distal end of the barrel to provide closure integrity for the syringe contents throughout the shelf life and is removed by the user prior to flushing administration. The syringe assembly 710 also includes a plunger 731 connected to an elongated plunger rod 732, the elongated plunger rod having a flange 734 at its proximal end.

[0216] Two separately packaged scrubbing pads (750, 760) loaded with a disinfectant are attached to the elongated body 712 of the syringe barrel 710 using an adhesive or an external plastic wrapping. The two separately packaged scrubbing pads (750, 760) provided enforce the disinfection solution (which might otherwise not be followed) and provide additional protection to the patient by including an additional cleaning step of disinfecting the seat or connection interface using IPA or a scrubbing device before administering the drug or locking solution, thereby further preventing the patient from potential infections. The syringe assembly 710 can be a pre-filled syringe assembly. It will be appreciated that the two scrubbing pads (750, 760) loaded with a disinfectant can be joined or connected together by a frangible or perforated portion to facilitate easy removal from the syringe barrel or syringe assembly. In an alternative embodiment, a shrink-wrap label can be used to adhere the two separate scrubbing pads (750, 760) loaded with a disinfectant to the syringe barrel, the shrink-wrap label can surround a portion of the barrel until the practitioner is ready to use the syringe assembly.

[0217] One of two individually packaged scrubbing pads (650, 660) loaded with a disinfectant is needed to disinfect the catheter to which the irrigation syringe is connected. In use, the clinician removes the first (750) of the two individually packaged scrubbing pads loaded with a disinfectant from the elongate body 712 of the syringe barrel 710, and the clinician places the first individually packaged scrubbing pad (750) loaded with a disinfectant on a sterile tray for subsequent use before irrigation. Then, the clinician removes the second (760) of the two individually packaged scrubbing pads loaded with a disinfectant from the elongate body 712 of the syringe barrel 710 and opens the individually packaged scrubbing pad (760) loaded with a disinfectant before irrigating the intravenous line. Then, the clinician uses the individually packaged scrubbing pad (760) to disinfect the needle-free connector ("NFC") by bringing the NFC into contact with the scrubbing pad (760) loaded with a disinfectant. 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 onto the NFC to connect the NFC to the irrigation syringe. Then the clinician irrigates the intravenous line. Next, the clinician opens the first individually packaged scrubbing pad (750) and contacts the male luer connector, the female luer connector, and the hemodialysis connector.

[0218] As described above, current products and SASH practices do not address any cleaning after the initial irrigation process because disinfection ends after the first irrigation. Embodiments of the present invention include two individually packaged scrubbing pads (750, 760) loaded with a disinfectant, which have the benefit of a two-step disinfection measure that provides additional protection to the patient by including an additional cleaning step of disinfecting the seat or connection interface with IPA or a scrubbing device before administering a drug or locking solution, thereby further preventing potential infection of the patient.

[0219] Embodiments

[0220] Various embodiments are listed below. It should be understood that the embodiments listed below can be combined with all aspects and other embodiments within the scope of the present invention.

[0221] Embodiment (a). A disinfection device, the disinfection device comprising:

[0222] A scrubbing device having a first cup, a second cup, and a bottom wall spanning both the first cup and the second cup,

[0223] The first cup includes: a first integral body; a first closed end; a first annular wall having a length L extending from the first closed end to a first open end Cand defining a first chamber that houses a first absorbent material and a first disinfectant, the first open end having a peripheral boss that extends radially inwardly from the first open end and defines an end face and a mating surface;

[0224] A first peelable seal disposed on the end face of the first cup to prevent the first disinfectant from leaving the first chamber;

[0225] A connecting element disposed on the bottom wall of the first cup of the scrubbing device;

[0226] The second cup includes: a second integral body; a second closed end; a second annular wall having a length L extending from the second closed end to a second open end C and defining a second chamber that houses a second absorbent material and a second disinfectant, the second open end having a peripheral boss that extends radially inwardly from the second open end and defines a second end face and a second mating surface; and

[0227] A second peelable seal disposed on the second end face of the second cup to prevent the second disinfectant from leaving the second chamber.

[0228] Example (b). The disinfection device according to example (a), wherein the connecting element is a threaded post.

[0229] Example (c). The disinfection device according to example (b), wherein the connecting element is a Luer lock collar.

[0230] Example (d). The disinfection device according to example (b), wherein the threaded post mates with a Luer lock collar of a flush syringe.

[0231] Example (e). The disinfection device according to example (a), wherein the peripheral boss is sized and adapted to receive a thumb press portion of a plunger rod.

[0232] Example (f). The disinfection device according to example (a), wherein the first cup and the second cup comprise a polypropylene or polyethylene material.

[0233] Example (g). The disinfection device according to example (a), wherein the first absorbent material and the second absorbent material are foams.

[0234] Example (h). The disinfection device according to claim 7, wherein the first absorbent material and the second absorbent material are polyurethane foams.

[0235] Example (i). The disinfection device according to Example (a), wherein the first absorbent material and the second absorbent material are sponges.

[0236] Example (j). The disinfection device according to Example (a), wherein the first absorbent material and the second absorbent material have slits.

[0237] Example (k). The disinfection device according to Example (a), wherein, once connected to a medical connector, compression of the first absorbent material and the second absorbent material towards the first closed end of the first chamber and the second chamber occurs.

[0238] Example (l). The disinfection device according to Example (a), wherein the medical connector is disinfected by contact with the first absorbent material and the second absorbent material.

[0239] Example (m). The disinfection device according to Example (a), wherein the first disinfectant and the second disinfectant are selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

[0240] Example (n). The disinfection device according to Example (m), wherein the first disinfectant and the second disinfectant include at least one of chlorhexidine gluconate and chlorhexidine diacetate.

[0241] Example (o). The disinfection device according to Example (m), wherein the first disinfectant and the second disinfectant are fluids or gels.

[0242] Example (p). The disinfection device according to Example (a), wherein the first peelable seal and the second peelable seal include an aluminum or multi-layer polymer film peel top.

[0243] Example (q). The disinfection device according to Example (a), wherein the first peelable seal and the second peelable seal are heat-sealed or induction-sealed to the mating surface.

[0244] Example (r). An assembly, the assembly comprising:

[0245] The disinfection unit according to embodiment (a) is connected to a syringe assembly, the syringe assembly comprising: a syringe barrel having an elongate body defining a chamber; an open proximal end having a flange; and a distal end having a tip with a passage therethrough in fluid communication with the chamber; a stopper connected to an elongate plunger rod having a thumb press at its proximal end; and a locking Luer collar at the distal end of the syringe barrel;

[0246] The first cup is connected to the locking Luer collar on the distal end of the syringe barrel; and

[0247] The second cup of the scrubbing device snap-fits onto the thumb press of the elongate plunger rod of the syringe assembly.

[0248] Embodiment (s). A method for disinfecting a medical connector, the method comprising:

[0249] Connecting the assembly according to embodiment (r) to a medical connector, wherein connecting includes removing the second cup from the syringe assembly,

[0250] Peeling the top web of the first peelable seal from the first cup;

[0251] Inserting the NFC into the chamber of the first cup and bringing the NFC into contact with the first absorbent material soaked in the first disinfectant;

[0252] Removing the first cup of the scrubbing device from the syringe barrel by applying torque to the assembly to screw the first cup off the locking Luer collar at the distal end of the syringe barrel;

[0253] Attaching a flush syringe to the IV catheter line by engaging the threads of the Luer lock collar on the distal end of the syringe barrel to connect the NFC to the flush syringe and flush the IV catheter line;

[0254] Unscrewing the flush syringe from the NFC and peeling the top web from the second cup to expose the second absorbent material soaked in the second disinfectant; and inserting the NFC into the chamber of the second cup and bringing the NFC into contact with the first absorbent material soaked in the first disinfectant.

[0255] Although the present disclosure has been shown and described with reference to certain exemplary embodiments thereof, those skilled in the art should understand that various changes in form and detail may be made thereto without departing from the spirit and scope of the embodiments of the present disclosure. In addition, the interior and / or the outer shell of the cap may be injection molded in one piece, or made by other suitable processes. Furthermore, it will be readily understood by those skilled in the art that, without departing from the spirit and scope of the embodiments of the present disclosure, the features or elements of any of the exemplary embodiments of the present disclosure described above and shown in the drawings may be implemented individually or in any combination (plural combinations).

[0256] In addition, the included drawings further depict non-limiting examples of the implementation of certain exemplary embodiments of the present disclosure and help to describe the related technologies. 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 design or method of the present invention as understood by those skilled in the relevant art of the present invention.

[0257] For those skilled in the art, other objects, advantages and salient features of the present disclosure will become apparent from the details provided and in conjunction with the drawings which disclose the exemplary embodiments of the present disclosure.

[0258] References throughout this specification to "one embodiment", "certain embodiments", "one or more embodiments" or "embodiments" mean that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of the phrases such as "in one or more embodiments", "in certain embodiments", "in one embodiment" or "in embodiments" throughout this specification are not necessarily referring to the same embodiment of the present disclosure. In addition, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0259] Although the present disclosure has been described herein with reference to specific embodiments, it should be understood that these embodiments are only for illustrating the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the methods and devices of the present disclosure without departing from the spirit and scope of the present disclosure. Accordingly, the present disclosure is intended to cover modifications and variations that fall within the scope of the appended claims and their equivalents.

Claims

1. A disinfection device, comprising: A scrubbing device having a first cup, a second cup, and a bottom wall spanning all of the first cup and the second cup, The first cup includes: a first one-piece body; a first closed end; a first annular wall having a length L extending from the first closed end to a first open end C and defining a first chamber that houses a first absorbent material and a first disinfectant, the first open end having a peripheral boss that extends radially inward from the first open end and defines an end face and a mating surface; A first peelable seal disposed on the end face 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 one-piece body; a second closed end; a second annular wall having a length L extending from the second closed end to a second open end C and defining a second chamber that houses a second absorbent material and a second disinfectant, the second open end having a peripheral boss that extends radially inwardly from the second open end and defines a second end face and a second engagement surface; and A second peelable seal disposed on the second end face of the second cup to prevent the second disinfectant from leaving the second chamber.

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

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

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

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

6. The disinfection device according to claim 1, wherein, The first cup and the second cup comprise a polypropylene or polyethylene material.

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

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

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

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

11. The disinfection device according to claim 1, wherein, Once connected to a medical connector, compression of the first absorbent material and the second absorbent material towards the first closed end of the first chamber and the second chamber occurs.

12. The disinfection device according to claim 11, wherein, The medical connector is disinfected by contact with the first absorbent material and the second absorbent material.

13. The disinfection device according to claim 1, wherein, The first disinfectant and the second disinfectant are selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tertiary butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

14. The disinfection device according to claim 13, wherein, The first disinfectant and the second disinfectant include at least one of chlorhexidine gluconate and chlorhexidine diacetate.

15. The disinfection device according to claim 13, wherein, The first disinfectant and the second disinfectant are fluids or gels.

16. The disinfection device according to claim 1, wherein, The first peelable seal and the second peelable seal comprise an aluminum or multi-layer polymer film peel top.

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

18. An assembly, comprising: The disinfection unit according to claim 1, connected to a syringe assembly, the 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 terminus with a passage therethrough in fluid communication with the chamber; a stopper connected to an elongated plunger rod having a thumb press portion at its proximal end; and a locking Luer-type collar located at the distal end of the syringe barrel; The first cup is connected to the locking Luer-type collar on the distal end of the syringe barrel; and The second cup snap of the scrubbing device is fitted to the thumb press portion of the elongated plunger rod of the syringe assembly.

19. A method for disinfecting a medical connector, comprising: connecting the assembly according to claim 18 to a medical connector, wherein connecting includes removing the second cup from the syringe assembly, peeling the top web of the first peelable seal from the first cup; inserting the NFC into the chamber of the first cup and bringing the NFC into contact with the first absorbent material soaked with the first disinfectant; removing the first cup of the scrubbing device from the syringe barrel by applying torque to the assembly to screw the first cup out of the locking Luer collar at the distal end of the syringe barrel; attaching a flush syringe to the IV catheter line by engaging the threads of the Luer lock collar on the distal end of the syringe barrel to connect the NFC to the flush syringe and flush the IV catheter line; unscrewing the flush syringe from the NFC and peeling the top web from the second cup to expose the second absorbent material soaked in the second disinfectant; and inserting the NFC into the chamber of the second cup and bringing the NFC into contact with the first absorbent material soaked with the first disinfectant.

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