Needleless connector disinfection device and method

Abstract

A needleless connector sanitizing device is provided that includes a body having a top surface and a bottom surface, a cavity within the body configured to receive a needleless connector, an actuation arm disposed on the body, a cartridge housing disposed on the actuation arm, a swab cartridge disposed within the cartridge housing, and a waste chamber disposed within the body configured to receive a used cleaning swab. The actuation arm is configured to slidably move the cartridge housing on the top surface of the body between an unactuated position in which a lowermost cleaning swab within the swab cartridge contacts an end of the needleless connector and an actuated position in which the cartridge housing is disposed above the waste chamber. Additional needleless connector sanitizing devices and methods of using the needleless connector sanitizing devices are also provided.

Description

Technical Field

[0001] This application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application Serial No. 63 / 170,890, titled "NEEDLELESS CONNECTOR DISINFECTION DEVICES AND METHODS," filed on April 5, 2021, the entire disclosure of which is incorporated herein by reference.

[0002] The present disclosure generally relates to needleless connectors, and more particularly to disinfection devices and methods for intravenous (IV) set needleless connectors.

Background Art

[0003] Typical infusion sets or IV sets are constructed by joining polymeric tubing segments to polymeric components, many of which have needleless connectors. Needleless connectors are sites where intraluminal microbial contamination can occur and require meticulous compliance with infection prevention practices during drug administration. Intraluminal contamination can lead to central lines associated with catheter-related bloodstream infections (CLABSI). Typical disinfection processes for needleless connectors involve wiping the needleless connector with an isopropyl alcohol (IPA) swab and allowing it to dry, or using a disinfectant cap. Current Infusion Nurses Society (INS) standards recommend disinfecting needleless connectors via vigorous mechanical scrubbing and drying times prior to each access of a vascular access device, and the use of passive disinfection caps is also considered. However, in the current overworked and pressured pace of the medical environment, this standard is not routinely followed by clinicians and caregivers, thus leading to frequent occurrences of CLABSI.

[0004] Adherence to connector disinfection procedures is not routinely followed for several reasons, including varying protocols across clinicians and / or healthcare environments, manufacturers specifying different lengths of scraping and drying times, and varying clinician adherence to cap usage. This often results in incomplete disinfection of connectors, which may, in some cases, increase the risk of bloodstream infection. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] For these reasons, it is desirable to provide an automated needleless connector disinfection device to ensure proper and complete disinfection after each use. [Means for solving the problem]

[0006] In one or more embodiments, the needleless connector disinfection device includes a body having a top surface and a bottom surface; a cavity located within the body and configured to receive a needleless connector; an operating arm disposed on the body; a cartridge housing disposed on the operating arm; a swab cartridge disposed within the cartridge housing; and a waste chamber disposed within the body and configured to receive a used cleaning swab, wherein the operating arm is configured to move the cartridge housing slidably on the top surface of the body between an unbiased position in which the lowest cleaning swab in the swab cartridge is in contact with the end of the needleless connector and a biased position in which the cartridge housing is located above the waste chamber.

[0007] In one or more embodiments, the needleless connector disinfection device includes a body having a top and bottom surface, a cavity located within the body and configured to receive a needleless connector, a cartridge housing pivotably disposed on the top surface of the body, an operating arm disposed on the cartridge housing, a swab cartridge disposed within the cartridge housing, and a waste chamber disposed within the body and configured to receive a used cleaning swab, wherein the cartridge housing is configured to pivotally move on the top surface of the body between an unbiased position in which the lowest cleaning swab in the swab cartridge is in contact with the end of the needleless connector and a biased position in which the cartridge housing is positioned above the waste chamber.

[0008] In one or more embodiments, a method of using a needleless connector disinfection device includes the steps of: pivoting a fixing member so that it exits the body of the needleless connector disinfection device; inserting a needleless connector into a cavity in the body through a connector port on the bottom surface of the body; bringing the end of the needleless connector into contact with the lowest cleaning swab in a cartridge housing located on the top surface of the body; pivoting the fixing member into the body to secure the needleless connector in the cavity; and applying force to an operating arm to move the cartridge housing from an unbiased position to a biased position, wherein in the unbiased position, the cartridge housing is... The cartridge housing is positioned above a syringe port aligned with a connector port and a cavity, and in the biased position, the cartridge housing is positioned above a waste chamber within the main body. The process includes: separating the lowest cleaning swab with a separation blade positioned above the waste chamber when the cartridge housing is moved to the biased position; receiving the separated cleaning swab in the waste chamber; releasing the force on the actuating arm; moving the cartridge housing back from the biased position to the unbiased position via a spring member; and bringing the end of the needleless connector into contact with the lowest cleaning swab inside the cartridge housing.

[0009] The attached drawings are included to provide a further understanding of the disclosure, are incorporated into and constitute part of this specification, and serve to illustrate embodiments of the disclosure and to explain the principles of the disclosure together with the descriptions. [Brief explanation of the drawing]

[0010] [Figure 1] This is a perspective view of an example patient care system having four fluid infusion pumps, each connected to its respective fluid supply to pump the contents of the fluid supply to the patient. [Figure 2] This is a top view of a typical assembled IV injection set. [Figure 3A] This is a perspective view of a typical needleless connector disinfection process. [Figure 3B] This is a perspective view of a typical needleless connector disinfection process. [Figure 4] This is a cross-sectional side view of one or more embodiments of a needleless connector disinfection device according to the disclosure. [Figure 5] Figure 4 is an exploded perspective view of the needleless connector disinfection device, depending on the manner of disclosure. [Figure 6] Figure 4 is a cross-sectional side view of the swab disposal use of the needleless connector disinfection device, according to the manner of disclosure. [Figure 7] Figure 4 is a perspective view of a needleless syringe engaged with the needleless connector disinfection device, as disclosed. [Figure 8] Figure 4 is a perspective view of the workflow use of the needleless connector disinfection device, depending on the manner of disclosure. [Figure 9] Figure 4 is a cross-sectional side view of the workflow use of the needleless connector disinfection device, depending on the manner of disclosure. [Figure 10] This is a perspective view of one or more embodiments of a needleless connector disinfection device according to the manner of disclosure. [Figure 11] Figure 10 is a cross-sectional side view of the needleless connector disinfection device in its first use, according to the manner of disclosure. [Figure 12] Figure 10 is a cross-sectional side view of the needleless connector disinfection device after its last use, as disclosed in the manner of disclosure. [Figure 13] Figure 10 is an exploded perspective view of the needleless connector disinfection device, depending on the manner of disclosure. [Figure 14] Figure 10 is a top view of the workflow use of the needleless connector disinfection device, depending on the manner of disclosure. [Figure 15] Figure 10 is a cross-sectional perspective view of the needleless connector disinfection device, according to the manner of disclosure. [Figure 16] Figure 10 is a perspective view of the needleless connector disinfection device, depending on the manner of disclosure. [Figure 17] Figure 10 is a perspective view of the workflow use of the needleless connector disinfection device, depending on the manner of disclosure. [Modes for carrying out the invention]

[0011] The detailed descriptions below describe various configurations of the subject art and are not intended to represent only the configurations in which the subject art can be implemented. The detailed descriptions include specific details for the purpose of providing a complete understanding of the subject art. Accordingly, dimensions are provided with respect to certain embodiments as non-limiting examples. However, it will be apparent to those skilled in the art that the subject art can be implemented without these specific details. In some examples, well-known structures and components are shown in the form of block diagrams to avoid obscuring the concepts of the subject art.

[0012] It should be understood that this disclosure includes examples of the subject art and does not limit the scope of the appended claims. Various aspects of the subject art are disclosed herein in accordance with specific, but non-limiting, examples. The various embodiments described herein may also be carried out in different ways and variations, and in accordance with desired uses or implementations.

[0013] Referring now more particularly to the drawings in which like reference numerals refer to like or corresponding elements, there is shown in FIG. 1 a patient care system 20 having four infusion pumps 22, 24, 26 and 28, each of which is fluidly connected to upstream fluid lines 30, 32, 34 and 36, respectively. Each of the four infusion pumps 22, 24, 26 and 28 is also fluidly connected to downstream fluid lines 31, 33, 35 and 37, respectively. The fluid lines may be any type of fluid conduit, such as an IV administration set, through which fluid can flow. It should be understood that any of a variety of pump mechanisms may be used, including syringe pumps.

[0014] Fluid supplies 38, 40, 42 and 44 may take various forms, but in this case are shown as bottles, inverted and suspended above the pumps. The fluid supplies may also take the form of other types of containers, including bags or syringes. The patient care system 20 and the fluid supplies 38, 40, 42 and 44 are both mounted on a roller stand, an IV pole 46, on a table, etc.

[0015] Separate infusion pumps 22, 24, 26 and 28 are used to inject each of the fluids of the fluid supplies into the patient. The infusion pumps are flow control devices that act on their respective fluid lines to move fluid from the fluid supplies through the fluid lines to the patient 48. Because separate pumps are used, each can be individually set with the pumping parameters or operating parameters necessary to inject a specific medical fluid from its respective fluid supply into the patient at a specific rate determined by the physician for that fluid. Such medical fluids may include drugs or nutrients or other fluids. The infusion pumps 22, 24, 26 and 28 are controlled by a pump control unit 60.

[0016] Fluid supply units 38, 40, 42, and 44 are each coupled to electronic data tags 81, 83, 85, and 87, respectively, or to an electronic transmitter. Any device or component associated with the injection system may be equipped with an electronic data tag, reader, or transmitter.

[0017] A typical infusion set may also be a gravity set that does not require the use of an infusion pump. For example, any of the fluid supply units 38, 40, 42, and 44 may be directly connected to patient 48 via a gravity IV set, in which case gravity will cause the fluid to flow through the infusion set into patient 48 without the help of a pump.

[0018] Typically, a medical fluid administration set has more components than the one shown in Figure 1, such as the one shown in Figure 2. The infusion set may be formed from any combination of infusion components and piping. Typically, the infusion components and piping are disposable products that are used once and then evacuated. The infusion components and piping may be formed from any suitable material (e.g., plastic, silicone, rubber), and many or all of them are transparent or translucent so that the internal fluid flow or fluid level can be seen.

[0019] As shown in Figure 2, the infusion set 120 may include a pump segment 165 connected together by a drip chamber 130, a check valve 140, and a roller clamp 150. The infusion set 120 may also include a Y-shaped joint 170 having a needleless connector 175 and a Luer lock connector 180 at the end of the infusion set 120. The Luer lock connector 180 may be used, for example, for connection to a catheter inserted into the patient's body. The infusion set 120 may include additional infusion components, which may be formed by any combination of components and piping 160.

[0020] As shown in Figure 3A, a typical method for disinfecting needleless connectors is to obtain an IPA swab 101, swab the needleless connector with it, and then allow it to air dry or pat dry with sterile gauze or cloth. This requires clinicians to remember to perform this cleaning task, find a new IPA swab, find a clean cloth, or wait a sufficient amount of time for air drying. Another typical method used in connection with or instead of IPA swab cleaning is to use a passive disinfectant cap 102, as shown in Figure 3B.

[0021] Figures 4 to 7 show a needleless connector disinfection device 200 for automatically cleaning a needleless connector 290 according to the embodiments of the disclosure. The needleless connector disinfection device 200 includes a body 210 having a cavity 212 configured to receive the needleless connector 290 through a connector port 211 and a needleless syringe 280 through a syringe port 213. For example, the cavity 212 may slide over the needleless connector 290 and surround part or all of it through the connector port 211. Similarly, the cavity 212 may slide over the needleless syringe 280 and surround part of it through the syringe port 213.

[0022] The main body 210 also includes a cartridge holder 214 configured to receive a swab cartridge 220. The swab cartridge 220 contains a number of individual cleaning swabs 222 (e.g., chlorhexidine swabs, IPA swabs) arranged in a stack within the swab cartridge 220. For example, the swab cartridge 220 may contain stacked cleaning swabs 222, and the needleless connector disinfection device 200 may be designed to be discarded after the last cleaning swab 222 has been used. The last cleaning swab 222 may be colored (e.g., red) to provide a visual indication that the last cleaning swab 222 has been used. The visibility of the colored cleaning swab 222 may indicate whether the entire needleless connector disinfection device 200 should be discarded or whether the current swab cartridge 220 needs to be replaced with a new one.

[0023] According to the embodiments of the disclosure, the needleless connector disinfection device 200 may be designed for continuous use after the last swab of the cleaning swab 222 has been used by simply replacing the used swab cartridge 220 with a new swab cartridge 220 having another supply of cleaning swabs 222. A cartridge seal 224 may be positioned to cover the bottom of the swab cartridge 220 and / or cartridge holder 214 before the first use of the needleless connector disinfection device 200. The cartridge seal 224 can seal in moisture of the cleaning solution in the cleaning swab 222 and keep the bottom surface of the bottom cleaning swab 222 clean before the first use.

[0024] The main body 210 also includes a waste chamber 216 positioned adjacent to the cavity 212. The waste chamber 216 is configured to receive each cleaning swab 222 after it has been used to clean the end face 292 of the needleless connector 290. The waste chamber 216 is sized to receive all of the cleaning swabs 222 contained within an entire swab cartridge 220, such as the used cleaning swabs 222 in the example discussed above. In an embodiment of the disclosure, the waste chamber 216 may be sized to receive used cleaning swabs 222 from multiple swab cartridges 220, such as when the needleless connector disinfection device 200 is configured to use replacement swab cartridges 220.

[0025] An elastic hinge arm 230 extends from the main body 210 and has a syringe alignment opening 232 and an ergonomic thumb grip 234. The syringe alignment opening 232 is configured to align with the cavity 212 when the elastic hinge arm 230 is positioned to allow insertion of a needleless syringe 280 into the needleless connector disinfection device 200 through the syringe alignment opening 232. The ergonomic thumb grip 234 may have a surface treatment (e.g., raised bumps, pattern formation) to provide a non-slip surface for the user to push the elastic hinge arm 230 toward the main body 210, even if the user's fingers are wet.

[0026] The elastic hinge arm 230 may be a flexible hinge having a biasing force that allows the elastic hinge arm 230 to return (for example, by automatically returning the spring to its straightened position) once the needleless syringe 280 is removed from the needleless connector disinfection device 200. The elastic hinge arm 230 is configured to slide the cartridge holder 214 together with the surrounded swab cartridge 220 between a closed position in which the cartridge holder 214 covers the syringe port 213 and an open position in which the syringe alignment opening 232 is aligned with the syringe port 213. During this sliding motion of the cartridge holder 214, the bottom cleaning swab 222 inside the cartridge holder 214 wipes across the end face 292 of the needleless connector 290, moves over the waste chamber 216, and is discarded into the waste chamber 216. When the needleless syringe 280 is removed, the biasing force of the elastic hinge arm 230 pulls the cartridge holder 214 back to its position above the syringe port 213, where a new, different bottom cleaning swab comes into contact with the end face 292 of the needleless connector 290, initiating a new disinfection operation of the end face 292.

[0027] The blade cover 240 is positioned on the syringe port 213 side of the main body 210. For example, the blade cover 240 may be elliptical in shape, serving as a guide rail for the reciprocating movement of the cartridge holder 214. The blade cover 240 includes a detaching blade 242 positioned above a portion of the waste chamber 216. The detaching blade 242 may be positioned to pierce the stack of cleaning swabs 222 just above the bottommost (e.g., used) cleaning swab 222 when the cartridge holder 214 / swab cartridge 220 is moved over the waste chamber 216, thereby detaching (e.g., peeling off) the bottommost cleaning swab 222 and causing it to fall into the waste chamber 216. The detaching blade 242 may be made of any suitable material, such as Teflon®.

[0028] The fixing member 250 may be coupled to the main body 210. The fixing member 250 may be a monkey ring mounted on the main body 210 via a hinge pin 252, in which case the fixing member 250 may be in an outward-rotated (e.g., pulled out) position when the needleless connector disinfection device 200 is matched or coupled with the needleless connector 290, or it may be pushed inward (e.g., pushed in) to fix or lock the needleless connector disinfection device 200 to the needleless connector 290. The fixing member 250 may include a locking projection 254 that engages with the surface of the needleless connector 280 to fix the needleless connector disinfection device 200 and the needleless connector 290 together. When the needleless connector disinfection device 200 is to be detached from the needleless connector 290, the fixing member 250 may be pulled outward from the main body 210 and rotated outward, thereby removing the locking projection 254 from the needleless connector 290.

[0029] During operation, the user holds the needleless connector disinfection device 200 and pushes the elastic hinge arm 230 (e.g., a spring-loaded lever), which slides the cartridge holder 214 / swab cartridge 220 from a closed position to an open position, thereby allowing the needleless syringe 280 to approach the syringe port 213. During the sliding motion, the used cleaning swab 222 slides and detaches from the stack of unused cleaning swabs 222, falling into the waste chamber 216. When the elastic hinge arm 230 is released, the swab cartridge 220 will have another cleaning swab 222 in contact with the needleless connector 290, thereby performing the disinfection operation.

[0030] Referring to Figures 8 and 9, a method 300 for using a needleless connector disinfection device (e.g., needleless connector disinfection device 200) is provided in an embodiment of the disclosure. In step 310, the needleless connector disinfection device is removed from its packaging. The entire device may be shipped / stored in sterile, sealed packaging (e.g., shrink wrap, heat-sealed plastic). In step 320, a seal (e.g., cartridge seal 224) is pulled and removed. This seal protects the bottom surface of the first cleaning swab in the cartridge (e.g., cleaning swab 222) and protects the stack of cleaning swabs in the cartridge during shipping / storage and before use. In step 330, the needleless connector disinfection device is aligned with a needleless connector (e.g., needleless connector 290), and in step 340, the needleless connector is inserted into the needleless connector disinfection device (e.g., through the connector port 211 into the cavity 212).

[0031] In step 350, the needleless connector disinfection device is locked to the needleless connector (for example, the fixing member 250 is moved inward so that the fixing projection 254 engages with the needleless connector 290). In step 360, the working arm (e.g., elastic hinge arm 230) is pushed inward toward the main body (e.g., body 210), causing the cartridge housing (e.g., cartridge housing 214) to slide over the waste chamber (e.g., waste chamber 216) to access the syringe port (e.g., syringe port 213 through the syringe alignment opening 232). As the cartridge housing slides to its predetermined position over the waste chamber, the blade (e.g., detaching blade 242) pushes into the swab stack above the lowest swab (e.g., used cleaning swab 222), detaching the used swab from the stack so that the used swab falls into the waste chamber.

[0032] In step 370, the syringe (e.g., needleless syringe 280) is aligned with the open syringe port, and in step 380, the syringe is inserted into the syringe port and locked or secured to the exposed top (e.g., end face 292) of the needleless connector. In step 390, after the desired contents of the syringe have been moved / pushed into the needleless connector, the syringe is unlocked and removed from the needleless connector disinfection device. In step 395, the actuating arm is released, and the biasing tension in the actuating arm springs back to its initial (e.g., unbiased) position, which causes the coupled swab cartridge to slide back over the syringe port and cover it. Here, the bottom swab in the swab stack (e.g., another unused cleaning swab 222) comes into contact with the end of the needleless connector, thereby disinfecting the end face, and the swab remains in contact with the end face until the next use of the needleless connector disinfection device, thereby providing continuous disinfection and protection of the end face.

[0033] Referring to Figure 9, the internal mechanism of the device in its first use in Method 300 is more clearly shown. In step 340, the top of the needleless connector 290 is positioned in the cavity 212 of the housing through the connector port 211, and the fixing member 250 is in a closed and fixed position, thus fixing the needleless connector disinfection device 200 to the needleless connector 290. As can be clearly seen, the initial cleaning swab 222 is engaged with the end face 292, and the elastic hinge arm 230 is in its initial unbiased position.

[0034] In step 360, when the ergonomic thumb grip 234 is pressed inward, the elastic hinge arm 230 moves inward toward the body 210, aligning the syringe alignment opening 232 with the syringe port 213, and positioning the cartridge housing 214 / swab cartridge 220 over the waste chamber 216, where the used cleaning swab 222 at the bottom is removed from the swab stack by the detachment blade 242 and falls into the waste chamber 216.

[0035] In step 370, the needleless syringe 280 is inserted into the syringe port 213, and it remains in place while it is positioned within the syringe port 213, even if the elastic hinge arm 230 is released by the user. Similarly, in step 390, when the needleless syringe 280 is removed or pulled out from the needleless connector disinfection device 200, the elastic hinge arm 230 will spring back to its initial position unless the user is pushing the ergonomic thumb grip 234 inward. On the other hand, if the user is applying an inward force to the ergonomic thumb grip 234 when the needleless syringe 280 is removed, the elastic hinge arm 230 will remain in the biased position until the user releases or eases the inward force. In either case, once the elastic hinge arm 230 returns to its unbiased position in step 395, the used cleaning swab 222 is positioned at the bottom of the waste chamber 216, with the newest cleaning swab 222 at the bottom being in place on the end face 292 of the needleless connector 290.

[0036] Figures 10–16 show a needleless connector disinfection device 400 for an automated cleaning needleless connector 290 according to an embodiment of the disclosure. The needleless connector disinfection device 400 includes a body 410 having a cavity 412 configured to receive the needleless connector 290 through a connector port 411 and a needleless syringe 280 through a syringe port 413. For example, the cavity 412 may slide over the needleless connector 290 and surround part or all of it through the connector port 411. In an embodiment of the disclosure, the end 294 of the needleless connector 290 slides through the cavity 412 until it exits the syringe port 413.

[0037] The main body 410 also includes a cartridge holder 414 configured to receive a swab cartridge 420. The swab cartridge 420 contains a number of individual cleaning swabs 422 (e.g., chlorhexidine swabs, IPA swabs) arranged in a stack within the swab cartridge 420. For example, the swab cartridge 420 may contain stacked cleaning swabs 422, and the needleless connector disinfection device 400 may be designed to be discarded after the last cleaning swab 422 has been used. The last cleaning swab 422 may be colored (e.g., red) to provide a visual indication that the last cleaning swab 422 has been used. The visibility of the colored cleaning swab 422 may indicate whether the entire needleless connector disinfection device 400 should be discarded or whether the current swab cartridge 420 needs to be replaced with a new swab cartridge 420.

[0038] According to the aspect of the disclosure, the needleless connector disinfection device 400 may be designed to be used continuously after the last swab of the cleaning swab 422 has been used by simply replacing the used swab cartridge 420 with a new swab cartridge 420 having another supply of cleaning swabs 422.

[0039] The main body 410 also includes a waste chamber 416 positioned adjacent to the cavity 412. The waste chamber 416 is configured to receive each cleaning swab 422 after it has been used to clean the end face 292 of the needleless connector 290. The waste chamber 416 is sized to receive all of the cleaning swabs 422 contained within an entire swab cartridge 420, such as the used cleaning swabs 422 in the example discussed above. In embodiments of the disclosure, the waste chamber 416 may be sized to receive used cleaning swabs 422 from multiple swab cartridges 420, such as when the needleless connector disinfection device 400 is configured to use replacement swab cartridges 420.

[0040] The detachment blade 442 may be positioned to pierce the stack of cleaning swabs 422 just above the bottommost (e.g., used) cleaning swab 422 when the cartridge holder 414 / swab cartridge 420 is moved over the waste chamber 416, thereby detaching (e.g., peeling off) the bottommost cleaning swab 422 and causing it to fall into the waste chamber 416. The detachment blade 442 may be made of any suitable material, such as Teflon®.

[0041] The spring 430 and pivot portion 415 of the cartridge housing 414 may be disposed within the pivot chamber 418 of the main body 410, and the spring 430 is configured to provide a biasing force to the cartridge housing 414. The cartridge housing 414 also includes an ergonomic thumb grip 434 that provides a surface for applying force to pivot the cartridge housing 414 around the pivot portion 415. The ergonomic thumb grip 434 may have a surface treatment (e.g., raised bumps, pattern formation) to provide a non-slip surface for the user to press and pivot the cartridge housing 414, even if the user's fingers are wet.

[0042] Once the needleless syringe 280 is removed from the needleless connector disinfection device 400, or when the user releases the ergonomic thumb grip 434, the biasing force of the spring 430 enables the cartridge housing 414 to pivot (for example, automatically return the spring to its initial position or straightened position). The spring 430 is configured to pivot the cartridge holder 414 together with the surrounded swab cartridge 420 between a closed position where the cartridge holder 414 covers the end 294 of the needleless connector 290 and an open position where the syringe cartridge holder 414 is aligned with the waste chamber 416. During this pivoting motion of the cartridge holder 414, the bottom cleaning swab 422 inside the cartridge holder 414 wipes across the end face 292 of the needleless connector 290, moves over the waste chamber 416, and is discarded into the waste chamber 416. When the needleless syringe 280 is removed and the ergonomic thumb grip 434 is released, the biasing force of the spring 430 pivots the cartridge holder 414 back to a position above the end 294 of the needleless connector 290 protruding from the syringe port 413, where a new, different bottom cleaning swab comes into contact with the end face 292 of the needleless connector 290, initiating a new disinfection operation of the end face 292.

[0043] The fixing member 450 may be coupled to the main body 410. The fixing member 450 may be a monkey ring mounted on the main body 410 via a hinge pin 452, in which case the fixing member 450 may be in an outward-rotated (e.g., pulled out) position when the needleless connector disinfection device 400 is matched or coupled with the needleless connector 290, or it may be pushed inward (e.g., pushed in) to fix or lock the needleless connector disinfection device 400 to the needleless connector 290. The fixing member 450 may include a locking projection 454 that engages with the surface of the needleless connector 280 to fix the needleless connector disinfection device 400 and the needleless connector 290 together. When the needleless connector disinfection device 400 is to be detached from the needleless connector 290, the fixing member 450 may be pulled outward from the main body 410 and rotated outward, thereby removing the locking projection 454 from the needleless connector 290.

[0044] During operation, the user holds the needleless connector disinfection device 400 and presses the ergonomic thumb grip 434, which pivots the cartridge holder 414 / swab cartridge 420 from the closed position to the open position, thereby allowing the needleless syringe 280 to approach the syringe port 413. During the pivoting motion, the used cleaning swab 422 slides and detaches from the stack of unused cleaning swabs 422 and falls into the waste chamber 416. When the ergonomic thumb grip 434 is released, the spring 430 pivots the cartridge holder 414 / swab cartridge 420 back to the closed position, in which position the swab cartridge 420 has another cleaning swab 422 in contact with the needleless connector 290, thereby performing the disinfection operation. In embodiments of the disclosure, the pivoting motion may be over any preferred angle, such as 105 degrees (Figure 14).

[0045] Referring to Figure 17, a method 500 of using a needleless connector disinfection device (e.g., needleless connector disinfection device 400) is provided in the disclosure. In step 510, once the needleless connector disinfection device is removed from its packaging, a quick-release lock (e.g., a retaining member 450) is released (e.g., pulled out / pivoted out of the body 410). The entire needleless connector disinfection device may be shipped / stored in sterile, sealed packaging (e.g., shrink wrap, heat-sealed plastic). In step 520, a needleless connector (e.g., needleless connector 290) is inserted into the needleless connector disinfection device (e.g., through the connector port 411 into the cavity 412). Here, the end of the needleless connector (e.g., end 294) may extend all the way through the cavity and protrude from the syringe port (e.g., syringe port 413), so that the end (e.g., end face 292) comes into contact with the bottom swab (e.g., cleaning swab 422) in the cartridge (e.g., swab cartridge 420). In step 530, the quick release lock is pushed / pivoted back to lock into the needleless connector (e.g., the locking projection 454 engages with the surface of the needleless connector 280), thereby securing the needleless connector disinfection device and the needleless connector together.

[0046] In step 540, the operating arm (e.g., ergonomic thumb grip 434) is pushed to pivot the cartridge housing (e.g., cartridge housing 414) on the main body (e.g., body 410), allowing the cartridge housing to pivot over the waste chamber (e.g., waste chamber 416) and approach the syringe port (e.g., syringe port 413). When the cartridge housing is pivoted to the predetermined position over the waste chamber, the blade (e.g., detachment blade 442) pushes into the swab stack above the lowest swab (e.g., used cleaning swab 422), detaching the used swab from the stack, causing the used cleaning swab to fall into the waste chamber.

[0047] In step 550, the syringe spinlock (e.g., syringe male spinlock 286) is aligned with the open syringe port and the protruding end of the needleless connector. In step 560, the syringe spinlock is inserted onto the end of the needleless connector and locked or secured to the exposed end of the needleless connector. Here, the syringe is aligned with the needleless connector. In step 570, after the desired contents of the syringe have been moved / pushed into the needleless connector, the syringe is unlocked and removed from the needleless connector disinfection device.

[0048] In step 580, the actuating arm is released, and the biasing tension in the spring (e.g., spring 430) pivots the cartridge housing back to its initial (e.g., unbiased) position, which pivots the coupled swab cartridge back onto the protruding end of the syringe port and needleless connector, covering it. Here, the bottom swab in the swab stack (e.g., another unused cleaning swab 422) comes into contact with the end of the needleless connector, thereby disinfecting the end face, and the swab remains in contact with the end face until the next use of the needleless connector disinfection device, thereby providing continuous disinfection and protection of the end face.

[0049] In one or more embodiments, the needleless connector disinfection device comprises a body having a top surface and a bottom surface; a cavity located within the body and configured to receive a needleless connector; an operating arm disposed on the body; a cartridge housing disposed on the operating arm; a swab cartridge disposed within the cartridge housing; and a waste chamber disposed within the body and configured to receive a used cleaning swab, wherein the operating arm is configured to move the cartridge housing slidably on the top surface of the body between an unbiased position in which the lowest cleaning swab in the swab cartridge is in contact with the end of the needleless connector and a biased position in which the cartridge housing is located above the waste chamber.

[0050] In an embodiment of the disclosure, the actuating arm is an elastic hinge member having an ergonomic thumb grip. In an embodiment of the disclosure, the actuating arm further comprises a syringe alignment opening configured to be positioned above the end of a needleless connector in a biased position. In an embodiment of the disclosure, a blade cover is disposed on the top surface of the body and comprises an outer peripheral portion that defines the range of movement of the cartridge housing between an unbiased position and a biased position. In an embodiment of the disclosure, the blade cover is disposed above the waste chamber and comprises a blade configured to detach the lowest cleaning swab from the swab cartridge when the cartridge housing is slidably moved above the waste chamber. In an embodiment of the disclosure, a connector port is disposed on the bottom surface of the body and configured to slidably receive the end of a needleless connector, and a syringe port is disposed on the top surface of the body and configured to slidably receive the end of a needleless syringe.

[0051] In an embodiment of the disclosure, a fixing member is coupled to a body and is configured to move between an open position that allows the needleless connector to slide within a cavity and a closed position that fixes the needleless connector in place within the cavity. In an embodiment of the disclosure, the fixing member comprises a hinge pin coupled to the body and a projection and is configured to pivot away from the body to reach the open position and pivot inward to reach the closed position and the projection is configured to engage with the surface of the needleless connector within the cavity to fix the needleless connector. In an embodiment of the disclosure, a swab cartridge contains a plurality of cleaning swabs arranged in a stack, the uppermost cleaning swab being colored differently from the other cleaning swabs. In an embodiment of the disclosure, a removable cartridge seal covers and protects the bottom of the swab cartridge before the first use of the needleless connector disinfection device and is configured to be pulled to freely initiate use of the needleless connector disinfection device.

[0052] In one or more embodiments, the needleless connector disinfection device comprises a body having a top surface and a bottom surface; a cavity located within the body and configured to receive a needleless connector; a cartridge housing pivotably disposed on the top surface of the body; an operating arm disposed on the cartridge housing; a swab cartridge disposed within the cartridge housing; and a waste chamber disposed within the body and configured to receive a used cleaning swab, wherein the cartridge housing is configured to pivotally move on the top surface of the body between an unbiased position in which the lowest cleaning swab in the swab cartridge is in contact with the end of the needleless connector and a biased position in which the cartridge housing is positioned above the waste chamber.

[0053] In an embodiment of disclosure, the actuating arm is a rigid projection from the cartridge housing and has an ergonomic thumb grip. In an embodiment of disclosure, a pivot chamber is disposed within the main body, and the pivot portion of the cartridge housing is disposed within the pivot chamber. In an embodiment of disclosure, a spring is disposed within the pivot chamber and is configured to provide a biasing force to the cartridge housing. In an embodiment of disclosure, a blade is disposed on the top surface of the main body above the waste chamber and is configured to detach the lowest cleaning swab from the swab cartridge as the cartridge housing is slidably moved above the waste chamber. In an embodiment of disclosure, a connector port is disposed on the bottom surface of the main body and is configured to slidably receive the end of a needleless connector.

[0054] In an embodiment of the disclosure, a syringe port is disposed on the top surface of the body and is configured to slidably receive the end of a needleless connector from a cavity, the end of the needleless connector protruding out of the cavity and beyond the top surface of the body when the needleless connector disinfection device is properly positioned on the needleless connector. In an embodiment of the disclosure, a fixing member is coupled to the body and comprises a hinge pin coupled to the body and a projection, the fixing member being configured to pivot away from the body to reach an open position that allows the needleless connector to slidably move within the cavity, and to pivot inward to reach a closed position that fixes the needleless connector in place within the cavity, the projection being configured to engage with the surface of the needleless connector within the cavity to fix the needleless connector. In an embodiment of the disclosure, a swab cartridge contains a plurality of cleaning swabs arranged in a stack, the uppermost cleaning swab being colored differently from the other cleaning swabs.

[0055] In one or more embodiments, a method for using a needleless connector disinfection device includes the steps of: pivoting a fixing member out of the body of the needleless connector disinfection device; inserting a needleless connector into a cavity in the body through a connector port on the bottom surface of the body; bringing the end of the needleless connector into contact with the lowest cleaning swab in the cartridge housing disposed on the top surface of the body; pivoting the fixing member into the body to fix the needleless connector in the cavity; and applying force to an operating arm to move the cartridge housing from an unbiased position to a biased position, wherein in the unbiased position, The cartridge housing is positioned above the connector port and the syringe port aligned with the cavity, and in the biased position, the cartridge housing is positioned above the waste chamber inside the main body; when the cartridge housing is moved to the biased position, the lowest cleaning swab is detached by a detaching blade positioned above the waste chamber; the detached cleaning swab is received in the waste chamber; the force on the operating arm is released; the cartridge housing is moved from the biased position to the unbiased position via a spring member; and the end of the needleless connector is brought into contact with the lowest cleaning swab inside the cartridge housing.

[0056] Any specific order or hierarchy in the disclosed process method should be understood as illustrative examples of the method. Based on design or implementation preferences, any specific order or hierarchy in the process may be rearranged, or all of the illustrated blocks may be performed simultaneously. In some implementations, any of the blocks may be performed concurrently.

[0057] This disclosure is provided to enable those skilled in the art to implement the various embodiments described herein. The disclosure provides various examples of the subject art, and the subject art is not limited to these examples. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the comprehensive principles set forth herein may be applied to other embodiments.

[0058] References to singular elements are intended to mean "one or more" rather than "one and only one" unless specifically stated otherwise. The term "several" refers to one or more unless specifically stated otherwise. Masculine pronouns (e.g., he) include feminine and neuter pronouns (e.g., she and her), and vice versa. Headings and subheadings, if present, are used solely for convenience and do not limit the invention.

[0059] The term “representative” is used herein to mean “acting as an example or illustration.” No embodiment or design described herein as “representative” should necessarily be construed as being preferred or advantageous over other embodiments or designs. In one embodiment, various alternative configurations or operations described herein may be considered at least equivalent.

[0060] When used herein, the expression “at least one” preceding a set of items, along with the term “or,” modifies the list as a whole, rather than each individual item in the list, in order to separate parts of an item. The expression “at least one” does not require the selection of at least one item; rather, it allows for the meaning of including at least one of any one of the items and / or at least one of any combination of the items and / or at least one of each of the items. For example, the expression “at least one of A, B, or C” may refer to A only, B only, or C only, or any combination of A, B, and C.

[0061] Expressions such as "aspects" do not imply that such aspects are essential to the subject art, or that such aspects apply to all configurations of the subject art. Disclosure relating to one aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. Expressions such as "aspects" may refer to one or more aspects, and vice versa. Expressions such as "examples" do not imply that such examples are essential to the subject art, or that such examples apply to all configurations of the subject art. Disclosure relating to an example may apply to all examples, or to one or more examples. An example may provide one or more examples. Expressions such as "examples" may refer to one or more examples, and vice versa. Expressions such as "configuration" do not imply that such configurations are essential to the subject art, or that such configurations apply to all configurations of the subject art. Disclosure relating to a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. Expressions such as "one composition" may refer to one or more compositions, and vice versa.

[0062] As used herein, the terms “determine” or “decide” encompass a wide range of actions. For example, “decide” may include, without user intervention, computing, calculating, processing, extracting, generating, acquiring, retrieving (e.g., retrieving a table, database, or other data structure), confirming, etc., via hardware elements. Also, “decide” may include, without user intervention, receiving (e.g., receiving information), accessing (e.g., accessing data in memory), etc. “Determine” may include, without user intervention, resolving, selecting, choosing, establishing, etc., via hardware elements.

[0063] As used herein, the terms “provide” or “to provide” encompass a broad range of actions. For example, “to provide” may include storing a value in a location on a storage device for subsequent retrieval, transmitting a value directly to a recipient via at least one wired or wireless communication medium, transmitting or storing a reference value to a value, etc. “To provide” may also include, via hardware elements, encoding, decoding, encrypting, cryptanalyzing, demonstrating, verifying, inserting, etc.

[0064] In one embodiment, unless otherwise stated, all measurements, values, ratings, locations, sizes, dimensions, and other specifications described in this specification, including the claims that follow, are approximate and not precise. In one embodiment, they are intended to have a reasonable range, consistent with the function to which they relate and consistent with what is customary in the art to which they belong.

[0065] It should be understood that the specific sequence or hierarchy of steps, actions, or processes disclosed are illustrative examples of a particular method. It should be understood that the specific sequence or hierarchy of steps, actions, or processes may be reconfigured based on design preferences. Some steps, actions, or processes may be performed simultaneously. Some or all steps, actions, or processes may be performed automatically without user intervention. The attached method claims present various elements of steps, actions, or processes in a sample sequence, if any exist, and do not imply that they are limited to the specific sequence or hierarchy presented.

[0066] All structural and functional equivalents of elements of various aspects described herein, known to those skilled in the art, or to be known thereafter, are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, anything disclosed herein is intended to be made available to the public, whether such disclosure is expressly enumerated in the claims or not. No claim element should be construed under Section 112(f) of the U.S. Patent Act unless it is expressly enumerated using the expression “means for…” or, in the case of a method claim, unless its element is enumerated using the expression “steps for…”. Furthermore, where terms such as “includes” and “have” are used, such terms are intended to be inclusive in the same manner as the term “equipment,” so as “equipment” is construed when used as a transitional term in the claims.

[0067] The title, background, overview, brief description of the drawings, and summary of the disclosure are thus incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as restrictive descriptions. They are presented with the understanding that they are not used to limit the scope or meaning of the claims. In addition, in the detailed description, it can be seen that the description provides illustrative examples and that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure should not be interpreted as reflecting an intention that the claimed subject matter requires features beyond those explicitly enumerated in each claim. Rather, as reflected in the following claims, the subject matter of the invention is less than all features of a single disclosed configuration or operation. The following claims are thus incorporated into the detailed description, and each of its claims stands independently as a individually claimed subject matter.

[0068] The claims are not intended to be limited to the embodiments described herein, but should be consistent with all the claims in their respective languages ​​and should encompass all legal equivalents. Nevertheless, none of the claims are intended to include, nor should they be interpreted, any subject matter that does not meet the requirements of Sections 101, 102, or 103 of the U.S. Patent Act.

Claims

1. A body having a top surface and a bottom surface, A cavity located within the aforementioned body, configured to receive a needleless connector, An operating arm is disposed on the main body, A cartridge housing is disposed on the aforementioned operating arm, A swab cartridge is disposed within the aforementioned cartridge housing, A waste chamber is disposed within the main body and configured to receive used cleaning swabs. A needleless connector disinfection device comprising, Needleless connector disinfection device, wherein the operating arm is configured to slidably move the cartridge housing on the top surface of the main body between an unbiased position in which the lowest cleaning swab in the swab cartridge is in contact with the end of the needleless connector and a biased position in which the cartridge housing is positioned above the waste chamber.

2. The needleless connector disinfection device according to claim 1, wherein the operating arm is an elastic hinge member having an ergonomic thumb grip.

3. The needleless connector disinfection device according to claim 2, wherein the operating arm further comprises a syringe alignment opening configured to be positioned above the end of the needleless connector in the biased position.

4. The needleless connector disinfection device according to claim 1, further comprising a blade cover disposed on the top surface of the main body, wherein the blade cover has an outer peripheral portion that defines the range of movement of the cartridge housing between the un-biased position and the biased position.

5. The needleless connector disinfection device according to claim 4, wherein the blade cover is disposed above the waste chamber and comprises a blade configured to detach the lowest cleaning swab from the swab cartridge when the cartridge housing is slidably moved above the waste chamber.

6. A connector port is disposed on the bottom surface of the main body and configured to slidably receive the end of the needleless connector, A syringe port is provided on the top surface of the main body and is configured to receive the end of a needleless syringe in a sliding manner. The needleless connector disinfection device according to claim 1, further comprising the above.

7. The needleless connector disinfection device according to claim 1, further comprising a fixing member coupled to the main body, the fixing member configured to move between an open position that allows the needleless connector to slide within the cavity and a closed position that fixes the needleless connector in a predetermined location within the cavity.

8. The aforementioned fixing member is A hinge pin attached to the main body, Protrusions and Equipped with, The fixing member is configured to pivot away from the main body to reach the open position and to pivot inward from the main body to reach the closed position. The needleless connector disinfection device according to claim 7, wherein the projection is configured to engage with the surface of the needleless connector within the cavity to secure the needleless connector.

9. The needleless connector disinfection device according to claim 1, wherein the swab cartridge contains a plurality of cleaning swabs arranged in a stack, the uppermost cleaning swab being colored differently from the other cleaning swabs.

10. The needleless connector disinfection device according to claim 1, further comprising a removable cartridge seal that covers and protects the bottom of the swab cartridge prior to the first use of the needleless connector disinfection device, wherein the cartridge seal is configured to be pulled to freely initiate use of the needleless connector disinfection device.

11. A body having a top surface and a bottom surface, A cavity located within the aforementioned main body, configured to receive a needleless connector, A cartridge housing is pivotably disposed on the top surface of the main body, An operating arm disposed on the cartridge housing, A swab cartridge is disposed within the aforementioned cartridge housing, A waste chamber is disposed within the main body and configured to receive used cleaning swabs. A needleless connector disinfection device comprising, Needleless connector disinfection device, wherein the cartridge housing is configured to pivot on the top surface of the main body between an unbiased position in which the lowest cleaning swab in the swab cartridge is in contact with the end of the needleless connector and a biased position in which the cartridge housing is positioned above the waste chamber.

12. The needleless connector disinfection device according to claim 11, wherein the operating arm is a rigid projection from the cartridge housing and has an ergonomic thumb grip.

13. The needleless connector disinfection device according to claim 11, further comprising a pivot chamber disposed within the main body, wherein the pivot portion of the cartridge housing is disposed within the pivot chamber.

14. The needleless connector disinfection device according to claim 13, further comprising a spring disposed within the pivot chamber, wherein the spring is configured to provide a biasing force to the cartridge housing.

15. The needleless connector disinfection device according to claim 11, further comprising a blade disposed on the top surface of the main body above the waste chamber, wherein the blade is configured to detach the lowest cleaning swab from the swab cartridge when the cartridge housing is slidably moved above the waste chamber.

16. The needleless connector disinfection device according to claim 11, further comprising a connector port disposed on the bottom surface of the main body and configured to slidably receive the end of the needleless connector.

17. A syringe port disposed on the top surface of the main body and configured to slidably receive the end of the needleless connector from the cavity, the end of the needleless connector further comprises a syringe port that protrudes out of the cavity and crosses the top surface of the main body when the needleless connector disinfection device is properly positioned on the needleless connector.

18. The device further comprises a fixing member which is connected to the main body and has a hinge pin connected to the main body and a projection, The fixing member is configured to pivot away from the body to reach an open position that allows the needleless connector to slide within the cavity, and to pivot inward from the body to reach a closed position that fixes the needleless connector in place within the cavity. The needleless connector disinfection device according to claim 11, wherein the projection is configured to engage with the surface of the needleless connector within the cavity to secure the needleless connector.

19. The needleless connector disinfection device according to claim 11, wherein the swab cartridge contains a plurality of cleaning swabs arranged in a stack, the top cleaning swab being colored differently from the other cleaning swabs.

20. A method of using a needleless connector disinfection device, The steps include pivoting the fixing member away from the main body of the needleless connector disinfection device, The steps include inserting the needleless connector into the cavity of the main body through the connector port on the bottom surface of the main body, The steps include bringing the end of the needleless connector into contact with the lowest cleaning swab inside the cartridge housing located on the top surface of the main body, The steps include pivoting the fixing member within the main body in order to fix the needleless connector within the cavity, A step of applying force to an operating arm to move the cartridge housing from a non-biased position to a biased position, wherein in the non-biased position, the cartridge housing is positioned above the connector port and the syringe port aligned with the cavity, and in the biased position, the cartridge housing is positioned above the waste chamber within the main body. When the cartridge housing is moved to the biased position, the lowermost cleaning swab is separated by a separation blade positioned above the waste chamber. The steps include receiving the detached cleaning swab into the waste chamber, The steps include releasing the force on the operating arm, A step of moving the cartridge housing from the biased position to the unbiased position via a spring member, The steps include bringing the end of the needleless connector into contact with a new, lowest cleaning swab inside the cartridge housing. Methods that include...

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