Related Application

[0001] This application claims the benefit of U.S. Provisional Application Serial Number 62/491 ,307, which was filed on April 28, 2017, the contents of which are hereby incorporated by reference in its entirety.

Technical Field

[0002] This disclosure relates to devices that use isopropyl alcohol ("IPA") to sterilize needleless connectors in healthcare environments where patients have intravenous ("IV") access and where infusion therapy is practiced. More specifically, this disclosure relates to IPA devices for sterilizing male and female fittings and connectors, such as luer fittings, used in IV infusion therapy.

Background

[0003] Healthcare associated infections are a major concern in regard to patient safety, as they can lead to serious complications or even death. One source in a healthcare setting by which infections can be introduced is through intravenous systems, such as those used to infuse drugs, fluids, blood, etc. into a patient's bloodstream. Routine connecting and disconnecting of different components of intravenous systems can introduce bacterial contamination which can lead to infection. It is therefore important to follow antiseptic techniques when installing, using, and maintaining intravenous systems.

[0004] Many of these connections are facilitated by what are known as "luer" fittings or connectors. Male luer connectors are commonly found on needleless syringes and include a nipple surrounded by a shroud. Female luer connectors can be found on items such as needles and IV tubes that are connectable to the needleless syringe. The female luer connector fits within the shroud of the male luer connector and has an opening for receiving the nipple. An outer surface of the female luer connector and an inner surface of the shroud of the male luer connector can include screw threads for facilitating the connection. Summary

[0005] The invention relates to a system for helping to maintain a sterile medical/surgical environment. According to one aspect, the invention relates to a sterilization system including workstation for supporting IPA devices for sterilizing male and female luer fittings used in IV infusion therapy.

[0006] According to one aspect, a system for facilitating the use of IPA devices for sterilizing luers includes a support plate configured to be supported on a support structure. The support structure includes a plurality of openings for receiving cup portions of an IPA device tray and one or more clip portions for retaining the IPA device tray on the support structure. The cup portions of the IPA device tray contain an IPA solution and an ampule for receiving a luer. The ampule is configured to retain the luer and support the luer in the tray on the support plate.

[0007] According to another aspect, alone or in combination with any other aspect, the clip portions can extend from an upper surface of the support plate and include retention members that are space from the upper surface to define a retention slot. The tray can include apertures through which the clip portions can extend to position the tray against the upper surface. The clip portions can be configured so that a portion of the tray adjacent the apertures can slide into the retention slot to retain the tray on the support structure.

[0008] According to another aspect, alone or in combination with any other aspect, the connection of the IPA device tray to the support plate can be configured such that the ampule can be removable from the cup portions in response to removal of a luer received therein.

[0009] According to another aspect, alone or in combination with any other aspect, the ampule can be for receiving a male luer.

[0010] According to another aspect, alone or in combination with any other aspect, the male luer can be a male luer of a needleless syringe. The connection of the IPA device tray to the support plate can be configured such that the ampule can receive the male luer of the syringe and the connection of the IPA device tray to the support plate can facilitate supporting the syringe via its being received in the ampule. [0011] According to another aspect, alone or in combination with any other aspect, the ampule can include a scrubber for scrubbing the luer while bathed in the IPA solution.

[0012] According to another aspect, alone or in combination with any other aspect, the support plate can include a sanitizer support portion configured to receive a hand sanitizing dispenser.

[0013] According to another aspect, alone or in combination with any other aspect, the support plate can include a sanitizer support portion and a hand sanitizing dispenser supported in the sanitizer support portion.

[0014] According to another aspect, alone or in combination with any other aspect, the hand sanitizing dispenser can include a pump with an actuator actuatable to cause hand sanitizer to be dispensed through a nozzle.

[0015] According to another aspect, alone or in combination with any other aspect, the sanitizer support portion and the hand sanitizing dispenser can be configured so that the actuator extends upward from an upper surface of the support plate and the nozzle extends laterally from the support plate.

[0016] According to another aspect, alone or in combination with any other aspect, the actuator can be a bellow actuator.

[0017] According to another aspect, alone or in combination with any other aspect, the system can include a sanitizer reservoir and a tube for connecting the sanitizer reservoir to the hand sanitizing dispenser. The support plate can include portions configured to support the sanitizer reservoir.

[0018] According to another aspect, alone or in combination with any other aspect, the support plate can include a storage bin tray portion for storing supplies.

[0019] According to another aspect, alone or in combination with any other aspect, the storage bin can be for storing female IPA devices.

[0020] According to another aspect, alone or in combination with any other aspect, the female IPA devices can include a cup containing an IPA solution and an ampule for receiving a female luer. The ampule can include a scrubber for scrubbing the luer while bathed in the IPA solution. [0021] According to another aspect, alone or in combination with any other aspect, the ampule can be removable from the cup with the female luer. The female luer can be affixed to the end of an IV tube. The support plate can include a cleat for supporting the IV tube with the ampule connected to the female luer.

[0022] According to another aspect, alone or in combination with any other aspect, the support plate can include a cleat for hanging IV tubing.

[0023] According to another aspect, alone or in combination with any other aspect, the system can include a clamp for connecting the support plate to an IV pole.

Drawings

[0024] Fig. 1 is a perspective view of a luer sterilization system according to one example configuration.

[0025] Fig. 2 is a perspective view of a workstation portion of the luer sterilization system of Fig. 1 .

[0026] Fig. 3 is a top plan view of the workstation of Fig. 2.

[0027] Fig. 4 is a bottom plan view of the workstation of Fig. 2.

[0028] Fig. 5 is a side view of the workstation of Fig. 2.

[0029] Fig. 6 is an end view of the workstation of Fig. 2.

[0030] Figs. 7A-7C are schematic views illustrating use of the workstation.

[0031] Fig. 8 is a schematic view, partially in section, of an IPA device that can be implemented with the workstation.

[0032] Fig. 9 is a schematic view, partially in section, of another IPA device that can be implemented with the workstation.

Description

[0033] A luer sterilization system 10 is illustrated in Fig. 1 . As shown in Fig. 1 , the system 10 includes workstation 100 including a support plate 1 02 for supporting various components of the sterilization system 10 that are described in further detail herein. Among these components are male IPA devices 20 supported on a tray 22, female IPA devices 50, a hand sanitizing dispenser 70, and a sanitizer reservoir 72. The workstation 100 includes a clamp 1 04 for connecting the support plate 102 to a support structure 106, such as an IV pole.

[0034] The support tray 1 02 can have a variety of constructions and material compositions. In one example configuration, the support tray 102 can have a single-piece molded plastic construction. The plastic material can, for example, be a high density polyethylene (HDPE) material. The support tray can be sterilized and offers a rugged, durable construction.

[0035] Referring to Figs. 1 -6, the support plate 1 02 has a generally rectangular planar main portion 1 10 that includes a plurality of openings 1 12 for receiving I PA devices. In the example configuration, there are twelve openings 1 12. The support plate 1 02 could, however, include a greater number of openings 1 12 or fewer openings 1 12.

[0036] The support plate 1 02 also includes support clips 1 14 that extend or protrude from an upper surface 1 16 of the main portion 1 10 of the support plate 102. The support clips 1 14 include retention members 120 that are spaced from the upper surface 1 16 and define a retention slot or recess 122.

[0037] The workstation 1 00 can include one or more T-shaped tethering cleats 130 that extend from an edge of the support plate 1 02 and around which IV tubing can be wrapped and/or organized. A smaller T-shaped cleat 1 32 can be used to support items, such as a bag for collecting waste or storing equipment. In one particular configuration, the cleat 132 can support the sanitizer reservoir 72 (see Fig. 1 ), such as a bag or bottle containing a sanitizer liquid or gel.

[0038] The workstation 1 00 can also include a storage tray or bin 140 that extends laterally from an edge of the support plate 102. The storage bin 140 can have an upper edge 142 that is co-planar with the upper surface 1 16 of the support plate 102. A sidewall 144 of the storage bin 140 extends beneath the support plate 102 and defines a receptacle space 146 in which supplies can be stored. Although the storage bin 140 is illustrated as being rectangular, it could be shaped and/or sized differently, according to need.

[0039] The workstation 100 can also include a sanitizer dispenser support portion 150 for supporting the sanitizer dispenser 70 that can be used to sanitize the users hands while operating via the workstation 100 and handling the medical equipment associated therewith. The support flange 150 includes a semi-circular recess 152 for receiving a sanitizer pump, and radially opposite support flanges 154 for receiving and releasably locking onto or otherwise retaining portions of the sanitizer pump 70.

[0040] As shown in Fig. 1 , the tray 22 on which the male IPA devices 20 are supported is configured to be received and connected to the workstation 100. More specifically, the tray 22 includes apertures 24 that are spaced and configured to coincide with the support clips 1 14 on the support plate 102. Installation of the tray 22 on to the workstation 100 is illustrated in Figs. 7A- 7C. Figs. 7A-7C illustrate a single male IPA device 20 and a single aperture 24 on the tray 22, with the understanding that the description of the functionality of the system 10 is identical for all other male IPA devices and tray apertures.

[0041] Referring to Fig. 7A, the tray 22 is positioned above the main portion 1 10 of the support plate 102 so that the male IPA devices 20 align with the openings 1 12 and the support clips 1 14 align with the apertures 24. Referring to Fig. 7B, the tray 22 is brought down, as indicated generally by the arrow, so that the male IPA devices 20 extend through the openings 1 12 and so that the support clips 1 14 extend through apertures 24. Referring to Fig. 7C, the tray 22 is slid to the left, as indicated generally by the arrow, to the position so that a portion of the tray 22 adjacent the aperture 24 enters the slot 122. The support clips 1 14 retain the tray 22 in the slot 122. The tray 22 is thereby connected to the workstation 1 00 by the support clips 1 14.

[0042] Referring to Fig. 8, the male IPA devices 20 on the tray 22 are for sterilizing male luer fittings and connectors used to make connections when administering intravenous medical therapy. A male luer can, for example, be the end connector typically found on a needleless syringe 90 (see Fig. 7B). The male IPA devices 20 can, for example, be IPA devices sold under the trademark Doclt®, which is a registered trademark belonging to SAXA Medical Solutions, LLC of Mentor, Ohio, USA.

[0043] The tray 22 includes a cup 26 associated with each male IPA device 20. Within each cup 26, each male IPA device 20 includes an ampule 24 that contains a scrubber 30 and is filled with a sterilizing fluid, such as isopropyl alcohol (IPA) or an IPA solution. The scrubber 30 can include scrubbing features, such as bristles. Prior to use, the ampule 24 is sealed by a removable, peel off cover 28, which is illustrated in dashed lines because it is removed in Fig. 8. To use the male IPA device 20, the cover is removed and a male luer 92 (e.g., a needleless syringe 90 luer) is inserted into the ampule 28. The ampule 28 is configured to form an interference fit with the male luer 92, which includes a nipple 94, which can be surrounded by a threaded shroud 96.

[0044] The scrubber 30 is configured to mate with and engage the male luer 92, while bathing the luer in the sterilizing fluid. To facilitate this, the ampule 24 can include a receiver 98, such as a cylindrical receiver, for receiving the nipple 94. The ampule 24 is configured to provide a fit sufficient to exert a retention force on the male luer 92. This retention force can be sufficient to support the syringe 90 via the workstation 1 00 via the connection between the tray 22 and the support plate 102 (See Figs. 7A-7C). Thus, the user can have the syringe 90 supported on the workstation in a ready condition.

[0045] When it is time to use the syringe 90, it can be removed from the tray 22. When the syringe 90 is removed, the ampule 24 remains attached to the male luer 92 and is removed from the cup 26 along with the syringe. To sterilize the male luer 92, the user twists the ampule 24 while still attached. The scrubber 30 scrubs the male luer 92 while bathed in the sterilizing fluid. The ampule 24 is thereafter removed and discarded, e.g., in a disposal bag attached to the workstation via the cleats 130, 1 32, leaving the male luer 92 sanitized/sterilized and ready for connection to a fitting, such as a female luer on an intravenous tube.

[0046] As shown in Fig. 1 , the tray 140 can be used to store female IPA devices 50 for sterilizing female luer fittings and connectors used to make connections when administering intravenous medical therapy. The female IPA device 50 can, for example, be IPA devices sold under the trademark HubScrub®, which is a registered trademark belonging to SAXA Medical Solutions, LLC of Mentor, Ohio, USA.

[0047] As shown in Fig. 9, a female luer 52 can, for example, be an end connector, or portion thereof, found on an intravenous (IV) tube 54. The female luer 52 is connectable with a male luer device, such as the male luer 92 of the syringe 90. The female luer 52 can include outer screw threads that interface with inner screw threads on the shroud 96 of the male luer 92 to interconnect the IV tube 54 to the syringe 90. The syringe 90 can be used to inject a liquid, such as drugs or a drug solution, into the IV tube 54 via the syringe. [0048] Each female IPA device 50 includes a cup 60 filled with an isopropyl alcohol (IPA) or IPA solution and which contains an ampule 62. The ampule 62 includes a female luer scrubber 64 and is. Prior to use, the ampule 62 is sealed by a removable, peel off cover 66, which is shown in dashed lines in Fig. 9. To use the male IPA device, the cover is removed and the female luer (e.g., IV tubing connector) is inserted into the ampule and received by the scrubber. The scrubber 64 is configured to mate with the female luer and can, for example, include a post 68 for receiving and guiding the female luer 52.

[0049] The scrubber 64 can include scrubbing features, such as bristles, sponge material, foam/rubber protrusions, etc. configured to mate with the shape and configuration of the female luer 52, which typically includes an aperture for receiving the nipple of the male luer. The post 68 can receive this aperture.

[0050] Since the female luers 52 are typically found on IV tubing 54, there is no need to use a tray to support the female IPA devices 50. This is because the female luers 52 typically dangle with the IV tubing 54 and sterilization is not required until the time that the luer connection is made (as opposed to the needleless syringe, which can be filled and placed on standby in the male IPA device and tray). Nevertheless, in a scenario where it may be desirable to hold the female luer component in a sterilized, standby condition, the female IPA device could be installed in the tray, which could then provide the required support.

[0051] To use the female IPA device 50, the female luer 52 is inserted into the device and rotated a number of rotations within a predetermined amount of time in order to sterilize the luer. For example, rotating the luer 52 for two 360 degree rotations within 1 0 seconds can be sufficient to sterilize the luer. Thereafter, the female IPA device 50 can be removed from the female luer 52/IV tubing 54 via a twist. The female IPA device 50 can then be discarded and the syringe can be used.

[0052] The hand sanitizing dispenser 70 is a pump for promoting and facilitating the use of hand sanitizer prior to or in conjunction with using the IPA device system 10. The workstation 100 is configured so that the support plate 102 includes a support portion 150 that facilitates an easy connection of the dispenser 70, such as a sliding, interference fit. The hand sanitizing dispenser 70 can be connected to the sanitizer reservoir 72, which can be hung from one of the cleats 130, 132, via tubing 74.

[0053] In the example configuration, the hand sanitizing dispenser 70 can be a bellow actuated pump that includes an actuator in the form of a bellow 80 that the user actuates via compression. The dispenser 70 also includes a nozzle 82 that projects laterally from the dispenser and from the workstation 100. Within the dispenser 70 are check valves that cause the sanitizer to be discharged from the nozzle 82 in response to depressing the bellow 80 and that cause sanitizer to be drawn into the dispenser when the bellow is released. It is through this depression-release action that the pump operates.

[0054] Advantageously, the bellow pump configuration of the hand sanitizing dispenser 70 and the support plate 102 is such that they facilitate one-hand usage of the pump to apply the sanitizer in a convenient and ergonomic manner. The support plate 102, particularly the support portion 150, is configured to position the dispenser 70 so that the bellow 80 extends from the surface of the support plate, e.g., upward perpendicularly from the plate, allows the user to place his index and middle fingers on opposite sides of the nozzle beneath the support plate with his/her hand wrapped around the edge of the plate. This positions the user's thumb conveniently positioned to actuate the bellow. With the nozzle facing outward, the sanitizer is discharged/squirted into the user's cupped hand wrapping around the support plate.

[0055] While aspects of the system and apparatus have been particularly shown and described with reference to the preferred embodiment above, it will be understood by those of ordinary skill in the art that various additional embodiments may be contemplated without departing from the spirit and scope of the disclosed embodiments. Other aspects, objects, and advantages can be obtained from a study of the drawings and the disclosure.