Needleless connector disinfection device and method

Abstract

Needleless connector disinfecting devices and methods are provided. The needleless connector disinfecting device includes a body having a top surface and a bottom surface, a cavity in the body configured to receive a needleless connector, an activation arm disposed on the body, a cartridge housing disposed on the activation arm, a swab cartridge disposed in the cartridge housing, and a disposal chamber disposed in the body configured to receive a used cleaning swab. The activation arm is configured to slidingly move the cartridge housing between a non-biased position, in which a bottom-most cleaning swab in the swab cartridge is in contact with an end portion of the needleless connector, and a biased position, in which the cartridge housing is disposed above the disposal chamber. Other needleless connector disinfecting devices and methods of using a needleless connector disinfecting device are also provided.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 170,890, filed April 5, 2021, entitled “Needleless Connector Sterilization Apparatus and Method,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to needleless connectors, and in particular to sterilization apparatus and methods for needleless connectors used in intravenous (IV) kits. Background Technology

[0004] Typical infusion or IV kits are constructed by connecting polymeric tubing segments to polymeric components, many of which have needle-free connectors. Needle-free connectors are potential sites of luminal microbial contamination, and infection prevention measures must be carefully followed during drug administration. Lumen contamination can lead to central catheter-related bloodstream infections (CLABSI). Typical sterilization procedures for needle-free connectors involve wiping with an isopropyl alcohol (IPA) swab and drying, or using a sterile cap. Current Infusion Nurses Association (INS) standards recommend sterilizing needle-free connectors via vigorous mechanical wiping and drying time before each insertion into the vascular access device, and consider the use of a passive sterile cap. However, in today's overloaded and hectic healthcare environment, clinicians and nurses do not routinely adhere to this standard, resulting in frequent CLABSIs.

[0005] For a variety of reasons, connector sterilization protocols are not followed correctly and routinely. These include protocols varying among clinicians and / or healthcare facilities, manufacturers specifying different lengths of wiping and drying times, and variability in clinician adherence to cap usage. This often results in incomplete connector sterilization and can potentially increase the risk of bloodstream infections.

[0006] For these reasons, there is a need to provide automated needle-free connector sterilization devices to ensure proper and thorough sterilization for each use. Summary of the Invention

[0007] In one or more embodiments, the needleless connector sterilization device includes a body having a top surface and a bottom surface, a cavity in the body (the cavity being configured to receive a needleless connector), an activation arm disposed on the body, a housing disposed on the activation arm, a swab tube disposed in the housing, and a treatment chamber disposed in the body (the treatment chamber being configured to receive a used cleaning swab), wherein the activation arm is configured to slidably move the housing on the top surface of the body between a non-biased position and a biased position, wherein in the non-biased position, the bottommost cleaning swab in the swab tube contacts the end portion of the needleless connector, and in the biased position, the housing is positioned above the treatment chamber.

[0008] In one or more embodiments, the needleless connector sterilization device includes a body having a top surface and a bottom surface, a cavity in the body (the cavity being configured to receive a needleless connector), a housing pivotally disposed on the top surface of the body, an activation arm disposed on the housing, a swab tube disposed in the housing, and a treatment chamber disposed in the body (the treatment chamber being configured to receive a used cleaning swab), wherein the housing is configured to pivotally move on the top surface of the body between a non-biased position and a biased position, in the non-biased position the bottommost cleaning swab in the swab tube contacts the end portion of the needleless connector, and in the biased position the housing is disposed above the treatment chamber.

[0009] In one or more embodiments, a method of using a needleless connector sterilization device includes: pivoting a retaining member out of the body of the needleless connector sterilization device; inserting a needleless connector through a connector port in the bottom surface of the body and into a cavity of the body; contacting an end portion of the needleless connector with a bottom cleaning swab in a housing disposed on the top surface of the body; pivoting the retaining member into the body to secure the needleless connector within the cavity; applying a force on an activation arm to move the housing from a non-biased position to a biased position, wherein in the non-biased position the housing is positioned above a syringe port aligned with the connector port and the cavity, and wherein in the biased position the housing is positioned above a treatment chamber in the body; separating the bottom cleaning swab using a separating blade disposed above the treatment chamber when the housing is moved to the biased position; receiving the separated cleaning swab into the treatment chamber; releasing the force on the activation arm; moving the housing from the biased position back to the non-biased position via a spring member; and contacting an end portion of the needleless connector with the bottom cleaning swab in the housing. Attached Figure Description

[0010] The accompanying drawings illustrate embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure. The drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification.

[0011] Figure 1A perspective view of an example patient care system is depicted, with four fluid infusion pumps, each connected to a corresponding fluid supply source for pumping the contents of the fluid supply source to the patient.

[0012] Figure 2 This is a top view of a typical assembled IV infusion kit.

[0013] Figure 3A and 3B A perspective view depicting a typical needle-free connector sterilization process is provided.

[0014] Figure 4 A cross-sectional side view of one or more embodiments of a needleless connector sterilization apparatus according to various aspects of this disclosure is depicted.

[0015] Figure 5 Depicting various aspects according to this disclosure Figure 4 Exploded perspective view of the needleless connector sterilization device.

[0016] Figure 6 Depicting various aspects according to this disclosure Figure 4 A cross-sectional side view of the swab disposal process using the needleless connector disinfection device.

[0017] Figure 7 Depicting aspects related to this disclosure Figure 4 A perspective view of a needleless syringe connected to a needleless connector sterilization device.

[0018] Figure 8 Depicting various aspects according to this disclosure Figure 4 A perspective view of the workflow of the needleless connector sterilization device.

[0019] Figure 9 Depicting various aspects according to this disclosure Figure 4 A cross-sectional side view of the working process of the needleless connector sterilization device.

[0020] Figure 10 Perspective views of one or more embodiments of a needleless connector sterilization apparatus according to various aspects of this disclosure are depicted.

[0021] Figure 11 Depicting various aspects according to this disclosure Figure 10 A cross-sectional side view of the needleless connector sterilization device after its first use.

[0022] Figure 12 Depicting various aspects according to this disclosure Figure 10 A cross-sectional side view of the needleless connector sterilization device after its last use.

[0023] Figure 13Depicting various aspects according to this disclosure Figure 10 Exploded perspective view of the needleless connector sterilization device.

[0024] Figure 14 Depicting various aspects according to this disclosure Figure 10 A top view of the workflow of the needleless connector sterilization device.

[0025] Figure 15 Depicting various aspects according to this disclosure Figure 10 Cross-sectional perspective view of the needleless connector sterilization device.

[0026] Figure 16 Depicting various aspects according to this disclosure Figure 10 A perspective view of a needleless connector sterilization device.

[0027] Figure 17 Depicting various aspects according to this disclosure Figure 10 A perspective view of the workflow of the needleless connector sterilization device. Detailed Implementation

[0028] The detailed description below depicts various configurations of the subject matter and is not intended to represent the only configuration in which the subject matter can be practiced. For the purpose of providing a thorough understanding of the subject matter, the detailed description includes specific details. Therefore, dimensions are provided for certain aspects as non-limiting examples. However, it will be apparent to those skilled in the art that the subject matter can be practiced without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concept of the subject matter.

[0029] It should be understood that this disclosure includes examples of the subject matter and does not limit the scope of the appended claims. Various aspects of the subject matter will now be disclosed based on specific, but not limiting, examples. The various embodiments described in this disclosure may be implemented in different ways and variations, and may suit the desired application or implementation.

[0030] Referring now to the accompanying drawings in more detail, in which similar reference numerals in several views denote similar or corresponding elements, Figure 1 A patient care system 20 is shown, comprising four infusion pumps 22, 24, 26, and 28, each 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. These fluid lines can be any type of fluid conduit through which fluid can flow, such as an IV administration kit. It should be understood that any of a variety of pump mechanisms can be used, including syringe pumps.

[0031] Fluid supply sources 38, 40, 42, and 44 are inverted and suspended above the pump. These fluid supply sources can take various forms, but are shown as bottles in this case. The fluid supply sources can also take the form of bags or other types of containers, including syringes. The patient care system 20 and the fluid supply sources 38, 40, 42, and 44 are all mounted to the roller stand, IV bar 46, desktop, etc.

[0032] Individual infusion pumps 22, 24, 26, and 28 are used to infuse each fluid from the fluid supply source into the patient. The infusion pumps are flow control devices that act on the corresponding fluid lines to move fluid from the fluid supply source through the fluid lines to the patient 48. Because independent pumps are used, each pump can be independently set to pumping or operating parameters required to infuse a specific medical fluid from its corresponding fluid supply source into the patient at a specific rate prescribed by the physician for that fluid. Such medical fluids may include medications, nutrients, or other fluids. Infusion pumps 22, 24, 26, and 28 are controlled by a pump control unit 60.

[0033] Fluid supply sources 38, 40, 42, and 44 are each connected to electronic data tags 81, 83, 85, and 87, or to electronic transmitters, respectively. Any device or component associated with the infusion system may be equipped with an electronic data tag, reader, or transmitter.

[0034] A typical infusion kit can also be a gravity kit that does not require the use of an infusion pump. For example, any of the fluid supply sources 38, 40, 42, and 44 can be directly connected to the patient 48 via a gravity IV kit, where gravity causes the fluid to flow through the infusion kit and into the patient 48 without the aid of a pump.

[0035] Typically, medical fluid application kits have more parts than Figure 1 More, such as Figure 2 As shown. The infusion kit can be formed from any combination of infusion components and tubing. Typically, the infusion components and tubing are single-use products that are discarded after a single use. The infusion components and tubing can be formed from any suitable material (e.g., plastic, silicone, rubber), many or all of which are transparent or translucent, allowing the internal fluid flow or level to be seen.

[0036] like Figure 2As shown, the infusion kit 120 may include an infusion chamber 130, a check valve 140, and a roller clamp 150 connected together via tubing 160. The infusion kit 120 may also include a Y-tee 170 with a Y-connector for connection to a needleless connector 175, and a Luer lock connector 180 at an end of the infusion kit 120. For example, the Luer lock connector 180 may be used for connection to a catheter inserted into a patient's body. The infusion kit 120 may include additional infusion components and may be formed from any combination of components and tubing 160.

[0037] like Figure 3A As shown, a typical method for sterilizing needle-free connectors is to obtain an IPA swab 101, wipe the connector, and then air-dry or gently pat dry with sterile gauze or cloth. This requires clinicians to remember to perform the cleaning task, find a new IPA swab and a clean cloth, or wait sufficient time for it to air-dry. Another typical method, in conjunction with or instead of using IPA swabs for cleaning, is to use... Figure 3B The passive disinfectant cap 102 shown.

[0038] Figure 4-7 A needleless connector sterilization device 200 for automatically cleaning a needleless connector 290 according to various aspects of this disclosure is shown. The needleless connector sterilization device 200 includes a body 210 having a cavity 212 configured to receive the needleless connector 290 via a connector port 211 and a needleless injector 280 via a syringe port 213. For example, the cavity 212 can slide through and close a portion or all of the needleless connector 290 via the connector port 211. Similarly, the cavity 212 can slide through and close a portion or all of the needleless connector 280 via the syringe port 213.

[0039] The body 210 also includes a cartridge holder 214 configured to receive the swab cartridge 220. The swab cartridge 220 contains multiple individual cleaning swabs 222 (e.g., chlorhexidine swabs, IPA swabs) stacked within the cartridge 220. For example, the cartridge 220 may contain 40 stacked cleaning swabs 222, and the needleless connector sterilizer 200 may be designed to be discarded after the last of the 40 cleaning swabs 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 is in use. The visibility of the colored cleaning swab 222 can indicate that the entire needleless connector sterilizer 200 should be discarded, or that an existing swab cartridge 220 needs to be replaced with a new one.

[0040] According to various aspects of this disclosure, the needleless connector sterilization device 200 can be designed to continue use after the last of 40 cleaning swabs 222 has been used, by simply replacing the used swab cartridge 220 with a new swab cartridge 220 supplied with clean cleaning swabs 222. A cartridge seal 224 can be arranged to cover the bottom of the swab cartridge 220 and / or cartridge holder 214 before the first use of the needleless connector sterilization device 200. The cartridge seal 224 can seal off moisture from the cleaning solution in the cleaning swab 222 and keep the bottom surface of the bottom cleaning swab 222 clean before first use.

[0041] The body 210 also includes a treatment chamber 216 arranged adjacent to the cavity 212. The treatment chamber 216 is configured to receive each cleaning swab 222 after cleaning the end face 292 of the needleless connector 290. The size of the treatment chamber 216 is adapted to receive all the cleaning swabs 222 contained in the entire swab cartridge 220, such as the 40 used cleaning swabs 222 in the example above. In various aspects of this disclosure, the size of the treatment chamber 216 may be adapted to receive used cleaning swabs 222 from multiple swab cartridges 220, for example when the needleless connector sterilization device 200 is configured to use replacement swab cartridges 220.

[0042] A resilient hinge arm 230 extends from the body 210 and has a syringe alignment opening 232 and an ergonomic thumb handle 234. The syringe alignment opening 232 is configured to align with the cavity 212 when the resilient hinge arm 230 is positioned to allow a needleless syringe 280 to be inserted through the syringe alignment opening 232 and into the needleless connector sterilization device 200. The ergonomic thumb handle 234 may be textured (e.g., raised, patterned) to provide a non-slip surface for the user to push the resilient hinge arm 230 toward the body 210, even if the user's thumb or fingers are wet.

[0043] The resilient hinge arm 230 may be a flexible hinge with bias force, which enables the resilient hinge arm 230 to return to its original position (e.g., automatically spring back to an upright position) once the needleless syringe 280 is removed from the needleless connector sterilization device 200. The resilient hinge arm 230 is configured to allow the cartridge holder 214 with the closed swab cartridge 220 to slide between a closed position where the cartridge holder 214 covers the syringe port 213 and an open position where the syringe alignment opening 232 is aligned with the syringe port 213. During this sliding movement of the cartridge holder 214, the bottom cleaning swab 222 in the cartridge holder 214 rubs against the end face 292 of the needleless connector 290, then moves past the end face and is discarded into the disposal chamber 216. When the needleless injector 280 is removed, the bias force of the resilient hinge arm 230 pulls the cartridge retainer 214 back to a position above the injector port 213, where a new, clean bottom cleaning swab contacts the end face 292 of the needleless connector 290 to initiate a new sterilization action on the end face 292.

[0044] A blade cap 240 is disposed on the syringe port 213 side of the body 210. For example, the blade cap 240 may be elliptical, acting as a guide for the reciprocating movement of the cartridge holder 214. The blade cap 240 includes a separation blade 242 disposed on a portion of the treatment chamber 216. The separation blade 242 may be positioned to separate (e.g., peel off) the bottommost cleaning swab 222 as the cartridge holder 214 / swab cartridge 220 moves above the treatment chamber 216, allowing it to fall into the treatment chamber 216. The separation blade 242 may be made of any suitable material, such as, for example, Teflon™.

[0045] The retaining member 250 can be coupled to the body 210. The retaining member 250 can be rotatably mounted to the body 210 via a hinge pin 252, wherein when the needleless connector sterilization device 200 mates with or is coupled to the needleless connector 290, the retaining member 250 can be in a screw-out (e.g., pull-out) position, and wherein the retaining member 250 can be pushed into a screw-in (e.g., push-in) position to secure or lock the needleless connector sterilization device 200 to the needleless connector 290. The retaining member 250 may include a locking protrusion 254 that engages the surface of the needleless connector 280 to secure the needleless connector sterilization device 200 and the needleless connector 290 together. When the needleless connector sterilization device 200 needs to be separated from the needleless connector 290, the retaining member 250 can be pulled outward from the body 210 and rotated, thereby disengaging the locking protrusion 254 from the needleless connector 290.

[0046] During operation, the user holds the needleless connector sterilization device 200 and presses the resilient 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 access to the syringe port 213 for the needleless injector 280. During this sliding action, the used cleaning swab 222 slides away from the unused stack of cleaning swabs 222 and falls into the disposal chamber 216. When the resilient hinge arm 230 is released, the swab cartridge 220 will have a clean cleaning swab 222 in contact with the needleless connector 290, thus performing the sterilization action.

[0047] Go to Figure 8 and Figure 9 In various aspects of this disclosure, a method 300 is provided using a needleless connector sterilization device (e.g., needleless connector sterilization device 200). In step 310, the needleless connector sterilization device is removed from its packaging. Here, the entire device can be shipped / stored in a sterile sealed package (e.g., shrink wrap, heat-sealed plastic). In step 320, a seal (e.g., a tube seal 224) is pulled out and removed. This seal protects the bottom surface of a first cleaning swab (e.g., cleaning swab 222) in the tube (e.g., swab tube 220), and the cleaning swabs stacked in the tube during shipping / storage and before use. In step 330, the needleless connector sterilization 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 sterilization device (e.g., inserted into cavity 212 through connector port 211).

[0048] In step 350, the needleless connector sterilization device is locked to the needleless connector (e.g., the retaining member 250 is moved inward so that the retaining protrusion 254 engages the needleless connector 290). In step 360, the activation arm (e.g., the resilient hinge arm 230) is pressed inward toward the body (e.g., the body 210), causing the housing (e.g., housing 214) to slide above the treatment chamber (e.g., treatment chamber 216) and providing an inlet to the syringe port (e.g., syringe port 213 via syringe alignment opening 232). Here, as the housing slides above the treatment chamber, a blade (e.g., a separating blade 242) is pushed into the stack of swabs above the bottom swabs (e.g., used cleaning swabs 222), thereby separating the used swabs from the stack so that the used swabs fall into the treatment chamber.

[0049] In step 370, the syringe (e.g., needle-free 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 with the exposed top (e.g., end face 292) of the needle-free connector. In step 390, after transferring / pushing the desired syringe contents into the needle-free connector, the syringe is unlocked and removed from the needle-free connector sterilization device. In step 395, the activation arm is released, and the bias tension in the activation arm causes it to spring back to its default (e.g., unbiased) position, causing the coupled swab tube to slide back and cover the syringe port. Here, the bottommost swab in the swab stack (e.g., a clean, unused cleaning swab 222) contacts the end face of the needle-free connector, thereby sterilizing the end face, and the swab remains in contact with the end face until the next use of the needle-free connector sterilization device, thus providing continuous sterilization and protection to the end face.

[0050] Go to Figure 9 The internal mechanism of the device during the first use of method 300 is shown more clearly. In step 340, the top portion of the needleless connector 290 is positioned within the cavity 212 of the housing via the connector port 211, and the retaining member 250 is in the closed and secured position, thereby securing the needleless connector sterilization device 200 to the needleless connector 290. It can be clearly seen that the first cleaning swab 222 engages with the end face 292, and the resilient hinge arm 230 is in the default non-biased position.

[0051] In step 360, when the ergonomic thumb handle 234 is pushed in, the resilient hinge arm 230 moves inward toward the body 210, thereby aligning the syringe alignment opening 232 with the syringe port 213 and positioning the cartridge 214 / swab cartridge 220 above the treatment chamber 216, where the used cleaning swab 222 at the bottom is removed from the swab stack by the separating blade 242 and falls into the treatment chamber 216.

[0052] In step 370, the needleless injector 280 is inserted into the injector port 213. Even if the user releases the resilient hinge arm 230, the resilient hinge arm will remain in the proper position when the needleless injector 280 is positioned within the injector port 213. Similarly, in step 390, when the needleless injector 280 is removed or pulled out of the needleless connector sterilization device 200, the resilient hinge arm 230 will return to its default position if the user does not press inward on the ergonomic thumb handle 234. On the other hand, if the user applies an inward force to the ergonomic thumb handle 234 when the needleless injector 280 is removed, the resilient hinge arm 230 will remain in a biased position until the user releases or relaxes the inward force. In either case, once the resilient hinge arm 230 returns to its unbiased position in step 395, the used cleaning swab 222 is placed at the bottom of the disposal chamber 216, and the bottommost new cleaning swab 222 is properly positioned on the end face 292 of the pinless connector 290.

[0053] Figure 10-16 A needleless connector sterilization apparatus 400 for automatically cleaning a needleless connector 290 is shown according to aspects of this disclosure. The needleless connector sterilization apparatus 400 includes a body 410 having a cavity 412 configured to receive the needleless connector 290 via a connector port 411 and a needleless injector 280 via a syringe port 413. For example, the cavity 412 can slide through and close a portion or all of the needleless connector 290 via the connector port 411. In aspects of this disclosure, an end portion 294 of the needleless connector 290 slides through the cavity 412 and out of the syringe port 413.

[0054] The body 410 also includes a cartridge holder 414 configured to receive a swab cartridge 420. The swab cartridge 420 contains multiple individual cleaning swabs 422 (e.g., chlorhexidine swabs, IPA swabs) stacked within the cartridge 420. For example, the cartridge 420 may contain 40 stacked cleaning swabs 422, and the needleless connector sterilization device 400 may be designed to be discarded after the last of the 40 cleaning swabs 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 is being used. The visibility of the colored cleaning swab 422 can indicate that the entire needleless connector sterilization device 400 should be discarded, or that an existing swab cartridge 420 needs to be replaced with a new one.

[0055] According to various aspects of this disclosure, the needleless connector sterilization device 400 can be designed to continue to be used after the last of 40 cleaning swabs 422 has been used, by simply replacing the used swab tube 420 with a new swab tube 420 supplied with clean cleaning swabs 422.

[0056] The body 410 also includes a treatment chamber 416 arranged adjacent to the cavity 412. The treatment chamber 416 is configured to receive each cleaning swab 422 after cleaning the end face 292 of the needleless connector 290. The size of the treatment chamber 416 is adapted to receive all the cleaning swabs 422 contained in the entire swab cartridge 420, such as the 40 used cleaning swabs 422 in the example above. In various aspects of this disclosure, the size of the treatment chamber 416 may be adapted to receive used cleaning swabs 422 from multiple swab cartridges 420, such as when the needleless connector sterilization device 400 is configured to use replacement swab cartridges 420.

[0057] The separating blade 442 can be positioned to enter the stack of cleaning swabs 422 directly above the bottommost (e.g., used) cleaning swab 422 when the tube holder 414 / swab tube 420 is moved above the treatment chamber 416, thereby separating (e.g., peeling off) the bottommost cleaning swab 422 so that it falls into the treatment chamber 416. The separating blade 442 can be any suitable material, such as, for example, Teflon(TM).

[0058] The spring 430 and the pivoting portion 415 of the housing 414 can be disposed in the pivot chamber 418 of the body 410, with the spring 430 configured to provide a biasing force on the housing 414. The housing 414 also includes an ergonomic thumb grip 434, which provides a surface for applying force to pivot the housing 414 about the pivoting portion 415. The ergonomic thumb grip 434 can be textured (e.g., raised bumps, patterned) to provide a non-slip surface for the user to push and pivot the housing 414, even if the user's thumb or fingers are wet.

[0059] Once the needleless syringe 280 is removed from the needleless connector sterilization device 400, or the user releases the ergonomic thumb handle 434, the biasing force of the spring 430 enables the cartridge 414 to perform a return pivoting movement (e.g., automatically springing back to the default or upright position). The spring 430 is configured to pivotally move the cartridge holder 414, which has a closed swab cartridge 420, between a closed position where the cartridge holder 414 covers the end portion 294 of the needleless connector 290 and an open position where the syringe cartridge holder 414 is aligned with the disposal chamber 416. During this pivoting movement of the cartridge holder 414, the bottom cleaning swab 422 in the cartridge holder 414 rubs across the end face 292 of the needleless connector 290, then moves past that end face and is discarded into the disposal chamber 416. When the needleless injector 280 is removed and the ergonomic thumb handle 434 is released, the biasing force of the spring 430 causes the cartridge retainer 414 to pivot back to a position above the end portion 294 of the needleless connector 290 protruding from the injector port 413, in which a new, clean bottom cleaning swab contacts the end face 292 of the needleless connector 290 to initiate a new disinfection action on the end face 292.

[0060] The retaining member 450 can be connected to the body 410. The retaining member 450 can be rotatably mounted to the body 410 via a hinge pin 452, wherein when the needleless connector sterilization device 400 mates with or is connected to the needleless connector 290, the retaining member 450 can be in a screw-out (e.g., pull-out) position, and wherein the retaining member 450 can be pushed into a screw-in (e.g., push-in) position to secure or lock the needleless connector sterilization device 400 to the needleless connector 290. The retaining member 450 may include a locking protrusion 454 that engages the surface of the needleless connector 280 to secure the needleless connector sterilization device 400 and the needleless connector 290 together. When the needleless connector sterilization device 400 needs to be separated from the needleless connector 290, the retaining member 450 can be pulled outward from the body 410 and rotated, thereby disengaging the locking protrusion 454 from the needleless connector 290.

[0061] In operation, the user holds the needleless connector sterilization device 400 and presses the ergonomic thumb handle 434, which rotates the cartridge holder 414 / swab cartridge 420 from a closed position to an open position, thereby allowing access to the syringe port 413 for the needleless injector 280. During the pivoting action, the used cleaning swab 422 slides, separates from the unused stack of cleaning swabs 422, and falls into the disposal chamber 416. When the ergonomic thumb handle 434 is released, the spring 430 pivots the cartridge holder 414 / swab cartridge 420 back to the closed position, in which the swab cartridge 420 will bring a clean cleaning swab 422 into contact with the needleless connector 290, thereby performing the sterilization action. In all aspects of this disclosure, the pivoting action can be performed through any suitable angle, such as, for example, 105 degrees. Figure 14 ).

[0062] Go to Figure 17 In various aspects of this disclosure, a method 500 is provided using a needleless connector sterilization device (e.g., needleless connector sterilization device 400). In step 510, once the needleless connector sterilization device is removed from its packaging, a quick-release lock (e.g., retaining member 450) is opened (e.g., pulled out / pivoted out of the body 410). Here, the entire needleless connector sterilization device can be shipped / stored in a sterile sealed package (e.g., shrink wrap, heat-sealed plastic). In step 520, a needleless connector (e.g., needleless connector 290) is inserted into the needleless connector sterilization device (e.g., inserted into the cavity 412 through connector port 411). Here, the end portion of the needleless connector (e.g., end portion 294) can extend through the cavity to protrude beyond the syringe port (e.g., syringe port 413) such that the end portion (e.g., end face 292) contacts the bottommost swab (e.g., cleaning swab 422) in the tube (e.g., swab tube 420). In step 530, the quick-release lock is pushed back / pivoted back to lock in the pinless connector (e.g., the locking protrusion 454 engages the surface of the pinless connector 280), thereby securing the pinless connector sterilization device and the pinless connector together.

[0063] In step 540, the activation arm (e.g., ergonomic thumb handle 434) is pressed to pivot the housing (e.g., housing 414) on the body (e.g., body 410), thereby pivoting the housing above the treatment chamber (e.g., treatment chamber 416) and providing access to the syringe port (e.g., syringe port 413). Here, as the housing pivots to the position above the treatment chamber, a blade (e.g., separation blade 442) is pushed into the swab stack above the bottom swabs (e.g., used cleaning swab 422), thereby separating the used swabs from the stack so that the used swabs fall into the treatment chamber.

[0064] In step 550, the syringe spinlock (e.g., syringe positive spinlock 286) is aligned with the open syringe port and the protruding end portion of the needleless connector. In step 560, the syringe spinlock is inserted onto the end portion of the needleless connector and locked or secured to the exposed end portion of the needleless connector. Here, the syringe is aligned with the needleless connector. In step 570, after the desired syringe contents have been transferred / push into the needleless connector, the syringe is unlocked and removed from the needleless connector sterilization device.

[0065] In step 580, the activation arm is released, and the bias tension in the spring (e.g., spring 430) causes the cartridge to pivot back to its default (e.g., unbiased) position, thereby causing the coupled swab cartridge to pivot back above the syringe port and cover the syringe port and the protruding end portion of the needleless connector. Here, the bottommost swab in the swab stack (e.g., a clean, unused cleaning swab 422) contacts 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, thus providing continuous disinfection and protection of the end face.

[0066] In one or more embodiments, the needleless connector sterilization device includes a body having a top surface and a bottom surface, a cavity in the body (the cavity being configured to receive a needleless connector), an activation arm disposed on the body, a housing disposed on the activation arm, a swab tube disposed in the housing, and a treatment chamber disposed in the body (the treatment chamber being configured to receive a used cleaning swab), wherein the activation arm is configured to slidably move the housing on the top surface of the body between a non-biased position and a biased position, wherein in the non-biased position, the bottommost cleaning swab in the swab tube contacts the end portion of the needleless connector, and in the biased position, the housing is positioned above the treatment chamber.

[0067] In aspects of this disclosure, the activation arm is a resilient hinge member with an ergonomic thumb handle. In aspects of this disclosure, the activation arm further includes a syringe alignment opening configured to be positioned above the end portion of the needleless connector in a biased position. In aspects of this disclosure, a blade cover is disposed on the top surface of the body, the blade cover including an outer periphery defining a travel range of the housing between a non-biased position and a biased position. In aspects of this disclosure, the blade cover includes a blade disposed above the treatment chamber and configured to detach the bottommost cleaning swab from the swab cartridge when the housing slides above the treatment chamber. In aspects of this disclosure, a connector port is disposed on the bottom surface of the body, the connector port being configured to slidably receive the end portion of the needleless connector, and a syringe port is disposed on the top surface of the body, the syringe port being configured to slidably receive the end portion of the needleless syringe.

[0068] In aspects of this disclosure, a retaining member is coupled to a body and configured to move between an open position and a closed position. In the open position, the needleless connector allows slidable movement within a cavity, and in the closed position, the needleless connector is secured in place within the cavity. In aspects of this disclosure, the retaining member includes a hinge pin coupled to the body and a protrusion, wherein the retaining member is configured to pivot away from the body to reach an open position and pivot into the body to reach a closed position, and wherein the protrusion is configured to engage a surface of the needleless connector within the cavity to secure the needleless connector. In aspects of this disclosure, a swab cartridge contains a plurality of cleaning swabs stacked together, wherein the uppermost cleaning swab is a different color from the other cleaning swabs. In aspects of this disclosure, a removable cartridge seal covers and protects the bottom portion of the swab cartridge before initial use of the needleless connector sterilization device, wherein the cartridge seal is configured to be freely pulled to initiate use of the needleless connector sterilization device.

[0069] In one or more embodiments, the needleless connector sterilization device includes a body having a top surface and a bottom surface, a cavity in the body (the cavity being configured to receive a needleless connector), a housing pivotally disposed on the top surface of the body, an activation arm disposed on the housing, a swab tube disposed in the housing, and a treatment chamber disposed in the body (the treatment chamber being configured to receive a used cleaning swab), wherein the housing is configured to pivotally move on the top surface of the body between a non-biased position and a biased position, in the non-biased position the bottommost cleaning swab in the swab tube contacts the end portion of the needleless connector, and in the biased position the housing is disposed above the treatment chamber.

[0070] In various aspects of this disclosure, the activation arm is a rigid protrusion extending from the housing and has an ergonomic thumb handle. In various aspects of this disclosure, a pivot chamber is disposed within the body, wherein a pivoting portion of the housing is disposed within the pivot chamber. In various aspects of this disclosure, a spring is disposed within the pivot chamber and configured to provide a biasing force on the housing. In various aspects of this disclosure, a blade is disposed on the top surface of the body above the treatment chamber, and the blade is configured to separate the bottommost cleaning swab from the swab cartridge when the housing slides above the treatment chamber. In various aspects of this disclosure, a connector port is disposed on the bottom surface of the body and is configured to slidably receive the end portion of a pinless connector.

[0071] In aspects of this disclosure, a syringe port is disposed on the top surface of the body, the syringe port being configured to slidably receive an end portion of a needleless connector from a cavity, wherein, when the needleless connector sterilization device is properly positioned on the needleless connector, the end portion of the needleless connector protrudes from the cavity and passes through the top surface of the body. In aspects of this disclosure, a retaining member is coupled to the body, the retaining member including a hinge pin coupled to the body and a protrusion, wherein the retaining member is configured to pivot away from the body to an open position allowing the needleless connector to slide within the cavity, and to pivot into the body to a closed position securing the needleless connector in place within the cavity, and wherein the protrusion is configured to engage the surface of the needleless connector within the cavity to secure the needleless connector. In aspects of this disclosure, a swab cartridge contains a plurality of cleaning swabs stacked together, wherein the uppermost cleaning swab is a different color from the other cleaning swabs.

[0072] In one or more embodiments, a method of using a needleless connector sterilization device includes: pivoting a retaining member out of the body of the needleless connector sterilization device; inserting a needleless connector through a connector port in the bottom surface of the body and into a cavity of the body; contacting an end portion of the needleless connector with a bottom cleaning swab in a housing disposed on the top surface of the body; pivoting the retaining member into the body to secure the needleless connector within the cavity; applying a force to an activation arm to move the housing from a non-biased position to a biased position, wherein in the non-biased position the housing is positioned above a syringe port aligned with the connector port and the cavity, and wherein in the biased position the housing is positioned above a treatment chamber in the body; separating the bottom cleaning swab using a separating blade disposed above the treatment chamber when the housing is moved to the biased position; receiving the separated cleaning swab into the treatment chamber; releasing the force on the activation arm; moving the housing from the biased position back to the non-biased position via a spring member; and contacting an end portion of the needleless connector with the bottom cleaning swab in the housing.

[0073] It should be understood that any particular order or hierarchy of the blocks in the disclosed process is illustrative of the method. Based on design or implementation preferences, it should be understood that the particular order or hierarchy of the blocks in the process may be rearranged, or all shown blocks may be executed. In some implementations, any blocks may be executed concurrently.

[0074] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. This disclosure provides various examples of the subject matter, and the subject matter is not limited to these examples. Various modifications to these aspects will be apparent to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0075] Unless otherwise specified, elements involving the singular form are not intended to mean "one and only one," but rather "one or more." Unless otherwise specified, the term "some" refers to one or more. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its), and vice versa. Titles and subtitles, if any, are used for convenience only and do not limit the invention.

[0076] The word “exemplary” is used herein to mean “serving as an example or illustration.” Any aspect or design described herein as “exemplary” is not necessarily to be construed as being better or more advantageous than other aspects or designs. In one respect, the various alternative constructions and operations described herein may be considered at least equivalent.

[0077] As used herein, the phrase “at least one” preceding a series of items (where any items are separated by the term “or”) modifies the listed items as a whole, rather than each individual item listed. The phrase “at least one” does not require the selection of at least one item; rather, it allows for the inclusion of at least one of any of the items, and / or at least one of any combination of items, and / or at least one of each item. For example, the phrase “at least one of A, B, or C” could refer to: only A, only B, or only C; or any combination of A, B, and C.

[0078] The phrase, such as "aspect," does not imply that such an aspect is essential to the art, or that such an aspect applies to all constructions of the art. Disclosure relating to an aspect may apply to all constructions, or one or more constructions. An aspect may provide one or more examples. The phrase, such as "aspect," may refer to one or more aspects, or vice versa. The phrase, such as "embodiment," does not imply that such an embodiment is essential to the art, or that such an embodiment applies to all constructions of the art. Disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. The phrase, such as "embodiment," may refer to one or more embodiments, or vice versa. The phrase, such as "construction," does not imply that such a construction is essential to the art, or that such a construction applies to all constructions of the art. Disclosure relating to a construction may apply to all constructions, or one or more constructions. A construction may provide one or more examples. The phrase, such as "construction," may refer to one or more constructions, or vice versa.

[0079] As used herein, the term "determine" encompasses a wide variety of actions. For example, "determine" can include performing calculations, computations, processing, derivations, generation, acquisition, searching (e.g., searching in a table, database, or other data structure), and ascertaining information via hardware components without user intervention. Furthermore, "determine" can include receiving (e.g., receiving information) and accessing (e.g., accessing data in memory) via hardware components without user intervention. "Determine" can also include parsing, selecting, choosing, and building via hardware components without user intervention.

[0080] As used herein, the term “provide” encompasses a wide variety of actions. For example, “providing” can include storing a value at a location on a storage device for later retrieval, transmitting a value directly to a recipient via at least one wired or wireless communication medium, transmitting or storing a reference to a value, etc. “Providing” can also include encoding, decoding, encrypting, decrypting, authenticating, verifying, inserting, etc., via hardware elements.

[0081] In one respect, unless otherwise specified, all measurements, numerical values, ratings, positions, sizes, dimensions, and other specifications set forth in this specification, including in the appended claims, are approximate, not precise. In another respect, they are intended to have a reasonable range consistent with the functions they pertain to and the conventions of the field to which they belong.

[0082] It should be understood that the specific order or hierarchy of the disclosed steps, operations, or processes is an illustration of an exemplary method. Based on design preferences, it should be understood that the specific order or hierarchy of steps, operations, or processes can be rearranged. Some steps, operations, or processes can be performed simultaneously. Some or all steps, operations, or processes can be performed automatically without user intervention. The appended method claims (if any) present the elements of the various steps, operations, or processes in an exemplary order and are not intended to limit one to the specific order or hierarchy presented.

[0083] All structural and functional equivalents of the elements throughout the various aspects described in this disclosure, known or to be known by one of ordinary skill in the art, are expressly incorporated herein by reference and are intended to be included in the claims. Furthermore, nothing disclosed herein is intended to be offered to the public, whether or not such disclosure is expressly stated in the claims. No claim element shall be construed in accordance with 35 U.S.SC §112(f) unless the element is expressly stated using the phrase “means for” or, in the case of a method claim, using the phrase “step for”. Furthermore, with regard to the scope of terms such as “comprising,” “having,” etc., such terms are intended to be inclusive in a manner similar to the term “comprising,” as interpreted when “comprising” is used as a transitional word in a claim.

[0084] The title, background art, summary of the invention, description of the drawings, and abstract of this disclosure are incorporated herein and are provided as illustrative examples rather than as limiting descriptions. The invention is submitted in such a manner that they are not intended to limit the scope or meaning of the claims. Furthermore, in the detailed description, it will be apparent that the description provides illustrative examples, and various features are combined in various embodiments for the purpose of simplifying the disclosure. The method of the disclosure should not be construed as reflecting an intention that the claimed subject matter requires more features than those expressly recited in each claim. Rather, as reflected in the appended claims, the inventive subject matter lies in all features of fewer than those of a single disclosed structure or operation. The appended claims are incorporated herein, wherein each claim exists independently as a separate claimed subject matter.

[0085] The claims are not intended to limit the aspects described herein, but rather to conform to the full scope consistent with the language of the claims and to include all legal equivalents. Nevertheless, none of the claims are intended to include subject matter that fails to satisfy the requirements of 35 U.S.SC § 101, 102, or 103, nor should they be interpreted in this manner.

Claims

1. A needle-free connector sterilization device, comprising: A body having a top surface and a bottom surface; The cavity in the body is configured to receive a pinless connector; An activation arm is provided on the main body; The cylindrical shell is disposed on the activation arm; The swab tube is disposed in the casing; as well as A treatment chamber is provided within the main body, the treatment chamber being configured to receive used cleaning swabs. The activation arm is configured to allow the housing to slide between a non-biased position and a biased position on the top surface of the body. In the non-biased position, the bottommost cleaning swab in the swab tube contacts the end portion of the needleless connector. In the biased position, the housing is positioned above the treatment chamber.

2. The needleless connector sterilization device according to claim 1, wherein, The activation arm is a flexible hinge component with an ergonomic thumb handle.

3. The needleless connector sterilization device according to claim 2, wherein, The activation arm further includes a syringe alignment opening configured to be positioned above the end portion of the needleless connector at the bias position.

4. The needleless connector sterilization device according to claim 1, further comprising a blade cover disposed on the top surface of the body, the blade cover including an outer periphery defining the travel range of the housing between a non-biased position and a biased position.

5. The needleless connector sterilization device according to claim 4, wherein, The blade cover includes blades disposed above the treatment chamber and configured to separate the bottommost cleaning swab from the swab tube when the casing slides above the treatment chamber.

6. The needleless connector sterilization device according to claim 1, further comprising: A connector port is provided on the bottom surface of the body, the connector port being configured to slidably receive the end portion of a pinless connector; as well as A syringe port is provided on the top surface of the body, the syringe port being configured to slidably receive the end portion of a needleless syringe.

7. The needleless connector sterilization device according to claim 1, further comprising: A fixing member is attached to the body, the fixing member being configured to move between an open position and a closed position, in which the pinless connector is allowed to slide within the cavity, and in the closed position, the pinless connector is fixed in place within the cavity.

8. The needleless connector sterilization device according to claim 7, wherein, The fixing component includes: The hinge pin connected to the body; and A protrusion, The fixing member is configured to pivot away from the body to reach the open position, and pivot into the body to reach the closed position. Furthermore, the protrusion is configured to engage the surface of the pinless connector within the cavity to secure the pinless connector.

9. The needleless connector sterilization device according to claim 1, wherein, The swab tube contains multiple cleaning swabs stacked together, wherein the topmost cleaning swab is a different color from the other cleaning swabs.

10. The needleless connector sterilization device of claim 1, further comprising a removable cylindrical seal that covers and protects the bottom portion of the swab tube before the first use of the needleless connector sterilization device, wherein, The cylindrical seal is configured to be freely pulled to initiate the use of the needleless connector sterilization device.

11. A needle-free connector sterilization device, comprising: A body having a top surface and a bottom surface; The cavity in the body is configured to receive a pinless connector; A cylindrical shell pivotally mounted on the top surface of the main body; An activation arm is provided on the cylindrical shell; The swab tube is disposed in the casing; as well as A treatment chamber is provided within the main body, the treatment chamber being configured to receive used cleaning swabs. The housing is configured to pivotally move on the top surface of the body between a non-biased position and a biased position. In the non-biased position, the bottommost cleaning swab in the swab tube contacts the end portion of the needleless connector. In the biased position, the housing is positioned above the treatment chamber.

12. The needle-free connector sterilization device according to claim 11, wherein, The activation arm is a rigid protrusion extending from the cylindrical shell and has an ergonomic thumb handle.

13. The needleless connector sterilization device according to claim 11, further comprising a pivot chamber disposed within the body, wherein, The pivoting portion of the cylindrical shell is located within the pivoting chamber.

14. The needleless connector sterilization device of claim 13, further comprising a spring disposed in the pivot chamber, the spring being configured to provide a biasing force on the housing.

15. The needleless connector sterilization device according to claim 11, further comprising blades disposed on the top surface of the body above the treatment chamber, the blades being configured to separate the bottommost cleaning swab from the swab tube when the housing slides above the treatment chamber.

16. The needleless connector sterilization device according to claim 11, further comprising: A connector port is disposed on the bottom surface of the body, the connector port being configured to slidably receive the end portion of the pinless connector.

17. The needleless connector sterilization device according to claim 11, further comprising: A syringe port is disposed on the top surface of the body, the syringe port being configured to slidably receive the end portion of the needleless connector from the cavity, wherein, when the needleless connector sterilization device is properly positioned on the needleless connector, the end portion of the needleless connector protrudes from the cavity and passes through the top surface of the body.

18. The needleless connector sterilization device according to claim 11, further comprising: A fixing member connected to the body, the fixing member including a hinge pin and a protrusion connected to the body. The fixing member is configured to pivot away from the body to an open position that allows the pinless connector to slide within the cavity, and to pivot into the body to a closed position that secures the pinless connector in place within the cavity. Furthermore, the protrusion is configured to engage the surface of the pinless connector within the cavity to secure the pinless connector.

19. The needleless connector sterilization device according to claim 11, wherein, The swab tube contains multiple cleaning swabs stacked together, wherein the topmost cleaning swab is a different color from the other cleaning swabs.

20. A method for using a needleless connector sterilization device, the method comprising: Rotate the fixing component out of the main body of the needleless connector sterilization device; The pinless connector is inserted through the connector port on the bottom surface of the body and into the cavity of the body; Make the end portion of the pinless connector contact the bottom cleaning swab in the cylindrical shell disposed on the top surface of the body; The fixing member is pivoted into the body to secure the pinless connector within the cavity; A force is applied to the activation arm to move the shell from a non-biased position to a biased position, wherein, in the non-biased position, the shell is positioned above a syringe port aligned with the connector port and the cavity, and wherein, in the biased position, the shell is positioned above a treatment chamber in the body. When the shell moves to the bias position, the bottom cleaning swab is separated by the separation blades located above the treatment chamber; The separated cleaning swabs are received into the treatment chamber; Release the force on the activated arm; The cylinder is moved from the biased position back to the non-biased position via a spring member; and Make the end portion of the pinless connector contact the bottommost cleaning swab in the housing.

Images