Open female Luer disinfection cap

Abstract

A disinfection cap configured to engage with an open female luer connector includes a housing having an open first end, a second end, and at least one sidewall extending between the first end and the second end. The cap also includes an absorbent support or sponge disposed within the housing, the absorbent support or sponge configured to contain a cleaning solution for cleaning and / or disinfecting a portion of the open female luer connector engaged with the cap. The cap also includes a stopper disposed within the housing configured to prevent the cleaning solution from entering the lumen of the open female luer connector.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims priority to U.S. Patent Application No. 18 / 070,828, titled "Open Female Luer Disinfection Cap", filed on November 29, 2022, the disclosure of which is hereby incorporated by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to caps for medical connectors and, in particular, to a medical cap configured to be attached to an open female Luer connector for sealing, cleaning, and disinfecting portions of the open female Luer connector.

[0004] Background Description

[0005] Vascular access devices (VADs) are commonly used medical devices that can include intravenous (IV) catheters, e.g., peripheral catheters or central venous catheters. If not properly maintained or if exposed to a non - sterile environment, VADs can become contaminated, blocked by blood clots, and / or can transmit infections. Additionally, once connected to a VAD to deliver fluids or medications to a patient, bacteria and other microorganisms can enter the patient's vascular system from access hubs, ports, or valves. Thus, each access hub, port, valve, or other connector configured to attach to a VAD is associated with some risk of transmitting catheter - related bloodstream infections (CRBSIs) to the patient.

[0006] Many healthcare facilities implement aseptic practices and procedures to ensure that VADs and access hubs or ports are used correctly and are not blocked or infected. These procedures typically include disinfecting the access hubs, ports, and VADs and flushing the catheter with a flush solution before use. Specifically, VAD practice standards generally recommend flushing procedures after catheter placement, before fluid infusion, and before and after medication administration, blood sampling, blood transfusion, and / or parenteral nutrition administration.

[0007] Practice standards may also require capping access hubs, ports, and valves with a disinfection cap when not in use to prevent microorganisms from entering the hub, port, or valve and to disinfect the areas of the hub, port, or valve that contact the VAD. A disinfection cap is a disposable cap device that contains a quantity of cleaning or disinfection solution for disinfecting portions of the port, hub, and valve. Thus, a disinfection cap can be both a barrier to prevent microorganisms, particles, and debris from contacting the portions of the hub, port, or VAD that should remain sterile and a disinfection or cleaning device configured to expose portions of the hub, port, and VAD to a cleaning and disinfection solution.

[0008] An open female Luer has no diaphragm and thus needs to be blocked or plugged to reduce the entry of cleaning or disinfection solutions (usually isopropyl alcohol (IPA)) into the fluid path. However, traditional disinfection caps for open female Luer connectors may not prevent disinfectants from entering the lumen of the open female Luer connector and thus into the fluid path within the open female Luer. The disinfection cap of the present disclosure is configured to address this issue and effectively prevent IPA from entering the lumen of the Luer connector. SUMMARY OF THE INVENTION

[0009] In one aspect of the present disclosure, a cap configured to engage with an open female Luer connector includes a housing having an open first end, a second end, and at least one sidewall extending between the first end and the second end, thereby defining a recess. The cap further includes an absorbent support or sponge that retains a disinfectant (e.g., isopropyl alcohol (IPA)) within an open-cell structure that can release the disinfectant when the plug is compressed by the open female Luer connector for cleaning and / or disinfecting the portion of the open female connector that engages with the cap. The cap may also include a bellows and / or a plug disposed within the recess of the housing that encapsulates the sponge but includes an opening to allow the disinfectant to move out of the sponge and onto the outer surface of the open female Luer connector. The plug may be configured to prevent IPA from entering the lumen of the open female Luer connector.

[0010] In another aspect of the present disclosure, the plug may be configured to allow the lumen of the open female Luer to be blocked prior to connecting the cap to the Luer. The cap may be rigid. The sponge attached to the bellows and / or the plug may be configured to allow the release of IPA as the cap threads are connected to the open female Luer. The Luer distal face and outer surface may thus be wetted by the released IPA, and thus disinfection of the open female Luer is achieved.

[0011] In another aspect of the present disclosure, a method of attaching the foregoing cap to an open female Luer connector includes the steps of inserting the distal open end of the open female Luer connector through the open first end of the housing such that the distal open end of the open female Luer connector contacts a plug disposed within the housing above the absorbent support to block or seal the lumen within the open female Luer connector. The method further includes the step of rotating the open female Luer connector relative to the housing to advance the distal opening of the open female Luer connector through the housing, thereby axially compressing the absorbent support and releasing the cleaning solution into the housing such that the portion of the open female Luer connector outside the lumen can be exposed to the cleaning solution.

[0012] According to another aspect of the present disclosure, the device may include a rigid cap, a sponge, a bellows, a plug, and IPA. The rigid cap may be a plastic cap that houses various components therein. The sponge may retain IPA in an open-cell structure and release IPA when compressed by an incoming female luer connector. The bellows may encapsulate the sponge and may further include incisions / slits in its lateral body that allow IPA to move out of the sponge into the space between the bellows and the inner surface of the rigid cap. The construction material may be but not limited to thermoplastics, elastomers, silicone, and / or rubber, and other materials. The plug may serve as a sealing element for the inner lumen of the female luer connector. This may restrict the entry of IPA into the lumen of the female luer connector and thus into the fluid path of the female luer connector. The IPA may be filled in the cap, and most of the IPA is retained in the sponge and serves as a disinfectant. The bellows and the sponge may be coupled to the bottom inner base of the rigid cap.

[0013] According to another aspect of the present disclosure, when disinfection and protection of a female luer type catheter seat or stopcock are required, the top web release film of the cap is removed, and the cap is attached to the female luer. The bellows and / or the plug first enter the inner lumen of the female luer connector and seal the lumen, thereby preventing the IPA from the cap from entering the fluid path in the female luer connector. As the connection between the cap and the female luer connector progresses, the plug and / or the bellows are compressed, and the sponge attached to the plug and / or the bellows may also be compressed and release IPA from the open-cell structure. The released IPA may wet the distal front surface and the luer side of the female luer connector and disinfect it due to the chemical action of the IPA. The cap may be finally connected to the female luer connector by using a threaded connection, and the connection may be maintained for up to 7 days if not removed.

[0014] According to an embodiment of the present invention, a disinfection cap configured to engage an open female luer connector including a lumen includes: a housing having an open first end, a second end, and at least one sidewall extending between the first end and the second end to define a recess; a plug disposed in the recess of the housing and configured to engage the open female luer connector to seal the lumen of the open female connector; and an absorbent support disposed in the recess of the housing and configured to hold a cleaning solution for cleaning and / or disinfecting a portion of the open female luer connector that engages the cap.

[0015] According to an embodiment of the present invention, the absorbent support includes a sponge.

[0016] According to an embodiment of the present invention, the cleaning solution includes, for example but not limited to, isopropyl alcohol (IPA), chlorhexidine, and povidone iodine, or any combination of isopropyl alcohol (IPA), chlorhexidine, and povidone iodine.

[0017] According to an embodiment of the present invention, when the female luer connector with an opening is engaged with the cap, a cleaning solution is exposed to a portion of the female luer connector with an opening for cleaning and / or disinfecting the female luer connector with an opening.

[0018] According to an embodiment of the present invention, the female luer connector with an opening further includes an outer surface and a thread extending from the outer surface, and the side wall of the housing further includes an inner surface, and the inner surface includes a thread for engaging with the thread on the outer surface of the female luer connector with an opening.

[0019] According to an embodiment of the present invention, the cap further includes a bellows having a first open end, a second open end, and a side wall defining a cylindrical opening configured to enclose an absorbent support, wherein the first open end of the bellows is configured to be connected to a plug to further enclose the absorbent support.

[0020] According to an embodiment of the present invention, the bellows further includes: a side wall having ridges and grooves configured to be compressed; and a plurality of openings located on the side wall, and the plurality of openings are configured to allow the cleaning solution to flow from the absorbent support into a recess formed by the housing to clean and disinfect a portion of the female luer connector with an opening when the absorbent support is compressed by inserting the female luer connector with an opening into the cap.

[0021] According to an embodiment of the present invention, the cleaning solution includes, but is not limited to, one or any combination of isopropyl alcohol (IPA), chlorhexidine, and povidone iodine, and the absorbent support includes a sponge.

[0022] According to an embodiment of the present invention, the plug includes a first disk configured to fit into the lumen of the female luer connector with an opening and seal the lumen.

[0023] According to an embodiment of the present invention, the plug further includes a second disk having a larger diameter than the first disk and connected to the first disk, and the second disk includes a plurality of holes for allowing the cleaning solution to move through the plug toward the first open end of the housing.

[0024] According to an embodiment of the present invention, the plug includes a hemispherical member configured to fit into the lumen of the female luer connector with an opening and seal the lumen.

[0025] According to an embodiment of the present invention, the plug further includes a cylindrical member having a first end fixed to the hemispherical member and a second end slidably engaged with a plug guide, and the plug guide includes a top open end for receiving the second end of the cylindrical member of the plug and a bottom second end connected to the housing.

[0026] According to an embodiment of the present invention, the absorbent support includes an open top end, an open bottom end, and a sidewall extending between the top and bottom ends, the sidewall defining an inner cylindrical opening configured to receive and surround a portion of the plug.

[0027] According to an embodiment of the present invention, the plug includes a cylindrical member having a first end configured to fit within and seal the lumen of an open female luer connector and a second end having a diameter larger than the first end, and the lumen is configured to further engage the open female luer connector.

[0028] According to an embodiment of the present invention, the absorbent support includes an open top end, an open bottom end, and a sidewall extending between the top and bottom ends, the sidewall defining an inner cylindrical opening configured to receive and surround a portion of the second end of the plug.

[0029] According to an embodiment of the present invention, inserting the open female luer connector into the housing causes the absorbent support to be more deeply axially compressed into the housing, and wherein the axial compression of the absorbent support discharges the cleaning solution from the absorbent support, thereby causing the cleaning solution to move through the interior of the housing and thereby contact the outer surface of the open female luer connector inserted into the housing.

[0030] According to an embodiment of the present invention, a method of attaching a cap to an open female luer connector includes: inserting the distal open end of the open female connector through the open first end of the housing such that the proximal end of the open female connector contacts the absorbent support and the plug disposed in the housing; and rotating the open female luer connector relative to the housing such that the proximal end of the open female luer connector is advanced through the housing, thereby axially compressing the absorbent support.

[0031] According to an embodiment of the present invention, a cap configured to engage an open female connector having a lumen includes: a housing having an open first end, a second end, and at least one sidewall extending between the first and second ends, the at least one sidewall defining a recess; a bellows including an open first end, an open second end, and at least one sidewall extending between the first and second ends, the at least one sidewall defining a cavity disposed in the recess defined by the housing; an absorbent support disposed in the cavity defined by the bellows and received by the sidewall of the bellows, the absorbent support configured to hold a cleaning solution for cleaning and disinfecting a portion of the female connector that engages the cap; and a plug connected to the open first end of the bellows, the plug configured to further receive the absorbent support and prevent the cleaning solution from entering the lumen of the female connector.

[0032] According to an embodiment of the present invention, the absorbent support includes a sponge, and the cleaning solution includes, for example, one or any combination of isopropyl alcohol (IPA), chlorhexidine, and povidone iodine.

[0033] According to an embodiment of the present invention, a cap configured to engage with a female connector having a lumen includes a rigid housing that includes an open first end, a second end, and a sidewall that extends between the first end and the second end to define a recess; a sponge disposed in the recess defined by the housing, the sponge configured to hold a disinfecting solution (e.g., isopropyl alcohol (IPA)) for cleaning and disinfecting a portion of the female connector that engages with the cap; and a plug configured to be inserted into the lumen of the female connector to prevent IPA from entering the lumen of the female connector.

[0034] According to an embodiment of the present invention, a cap configured to engage with an open female connector having a lumen includes: a housing having an open first end, a second end, and at least one sidewall that extends between the first end and the second end to define a recess; a bellows including an open first end, an open second end, and at least one sidewall that extends between the first end and the second end to define a cavity, the cavity being disposed in the recess defined by the housing; an absorbent support disposed in the cavity defined by the bellows and received by the sidewall of the bellows, the absorbent support configured to hold a cleaning solution for cleaning and / or disinfecting a portion of the female connector that engages with the cap; and a plug connected to the open first end of the bellows, the plug configured to further receive the absorbent support and prevent the cleaning solution from entering the lumen of the female connector.

[0035] According to an embodiment of the present invention, the open female connector includes an open female Luer connector.

[0036] According to an embodiment of the present invention, the absorbent support includes a sponge.

[0037] According to an embodiment of the present invention, the plug includes at least one disk configured to prevent the cleaning solution from entering the lumen of the open female Luer connector.

[0038] According to an embodiment of the present invention, when the open female Luer connector is engaged with the cap, a portion of the open female Luer connector is inserted into the recess defined by the housing, and a portion of the plug is inserted into the lumen of the female connector.

[0039] According to an embodiment of the present invention, when the open female Luer connector is engaged with the cap, the cleaning solution is exposed to portions of the open female Luer connector for cleaning and / or disinfecting those portions of the open female Luer connector.

[0040] According to an embodiment of the present invention, the size of the cap is designed to receive open female Luer connectors having different configurations and sizes.

[0041] According to an embodiment of the present invention, the housing comprises a rigid thermoplastic polymer, the rigid thermoplastic polymer comprising at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.

[0042] According to an embodiment of the present invention, the housing includes a plurality of ridges or ribs (for easier grasping of the housing) extending outwardly from the outer surface of the housing.

[0043] According to an embodiment of the present invention, the absorbent support or sponge is axially compressible.

[0044] According to an embodiment of the present invention, the recess defined by the housing has an inner diameter corresponding to the outer diameter of the absorbent support or sponge.

[0045] According to an embodiment of the present invention, the absorbent support or sponge includes an axially compressible cylindrical member.

[0046] According to an embodiment of the present invention, the absorbent support or sponge includes a thermoplastic elastomer, such as silicone, polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene).

[0047] According to an embodiment of the present invention, the bellows includes an open first end, an open second end, and a sidewall extending between the first end and the second end, thereby defining a cavity, the size of the cavity being designed to enclose the absorbent support or sponge.

[0048] According to an embodiment of the present invention, the sidewall of the bellows is formed to include a plurality of ridges extending radially outwardly from the sidewall of the bellows, the ridges configured to deform outwardly when the bellows is compressed.

[0049] According to an embodiment of the present invention, the housing further includes a plurality of threads disposed on the inner surface of the sidewall of the housing, the threads configured to engage a portion of the open female Luer connector and rotatably secure the open female Luer connector within the housing.

[0050] According to an embodiment of the present invention, the sidewall of the bellows includes at least one opening for allowing a cleaning solution to pass from the absorbent support through the bellows into the recess defined by the opening.

[0051] According to an embodiment of the present invention, the plug is formed of the same rigid thermoplastic polymer as the housing.

[0052] According to an embodiment of the present invention, the absorbent support includes a thermoplastic elastomer, such as silicone, polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene).

[0053] According to an embodiment of the present invention, the absorbent support includes a sponge.

[0054] According to an embodiment of the present invention, the absorbent support includes an open-cell foam, such as a porous foam having a thermoplastic elastomer.

[0055] According to an embodiment of the present invention, inserting an open female luer connector into the housing axially compresses the absorbent support further into the housing.

[0056] According to an embodiment of the present invention, the axial compression of the absorbent support discharges the cleaning solution from the inner absorbent support, causing the cleaning solution to move through the interior of the housing and thereby contact the outer surface of the open female luer connector inserted into the housing.

[0057] According to an embodiment of the present invention, the cleaning solution may include isopropyl alcohol (IPA), chlorhexidine, or povidone iodine.

[0058] According to an embodiment of the present invention, a plug is disposed in the housing above the absorbent support, and the plug is configured to seal the open end of the open female luer connector, thereby preventing the cleaning solution from entering the lumen of the open female connector.

[0059] According to an embodiment of the present invention, the plug is positioned to allow the cleaning solution discharged from the absorbent member to move past the plug toward the first open end of the housing when the absorbent member is axially compressed.

[0060] According to an embodiment of the present invention, the outer diameter of the plug is smaller than the inner diameter of the housing.

[0061] According to an embodiment of the present invention, the plug includes at least one of a hole, a cut-out portion, a groove, a slit, or a slot to allow the cleaning solution to move past the plug toward the open first end of the housing while the plug prevents the cleaning solution from entering the lumen of the open female luer connector.

[0062] According to an embodiment of the present invention, a method of attaching a cap to an open female luer connector includes: inserting the distal open end of the open female luer connector through the open first end of the housing such that the distal open end of the open female luer connector contacts a plug disposed in the housing and adjacent to the absorbent support; and rotating the open female luer connector relative to the housing such that the distal open end of the open female luer connector is advanced through the housing, thereby axially compressing the absorbent support.

[0063] According to an embodiment of the present invention, advancing the distal open end of the open female luer connector through the housing causes the cleaning solution to be discharged from the absorbent support and move through the housing, thereby contacting the outer surface of the open female luer connector.

[0064] According to an embodiment of the present invention, the contact between the distal open end of the female luer connector and the plug seals the distal open end of the female luer connector, thereby preventing the cleaning solution from entering the lumen of the female luer connector.

[0065] According to an embodiment of the present invention, once the absorbent support is axially compressed, the cleaning solution moves through the plug towards the open first end of the housing, thereby contacting the outer surface of the distal open end of the female luer connector.

[0066] According to an embodiment of the present invention, a method of manufacturing the cap includes inserting an absorbent support into a recess of the housing; and inserting a plug near the absorbent support.

[0067] According to an embodiment of the present invention, the housing includes a rigid thermoplastic polymer having at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene. BRIEF DESCRIPTION OF THE DRAWINGS

[0068] FIG. 1 is a cross-sectional view of a known female luer connector in the prior art.

[0069] Figure 2 is a cross-sectional view of a disinfection cap connected to a female luer connector according to one aspect of the present disclosure.

[0070] Figure 3 is according to one aspect of the present disclosure Figure 2 exploded perspective view of the cap.

[0071] Figure 4 is according to one aspect of the present disclosure Figure 2 exploded cross-sectional view of the cap.

[0072] Figure 5 is according to one aspect of the present disclosure Figure 2 perspective view of the bellows and the cap.

[0073] Figure 6A is before inserting the male connector into the cap Figure 2 exploded cross-sectional view of the cap and the female luer connector.

[0074] Figure 6B is Figure 2 perspective view of the cap, wherein the female luer connector is inserted into the cap.

[0075] Figure 6C is Figure 2 cross-sectional view of the disinfection cap, wherein the female luer connector is inserted into the cap.

[0076] Figure 7A cross-sectional view of another example of a sterilization cap connected to an open female Luer connector according to another aspect of the present disclosure.

[0077] Figure 8 is Figure 7 An exploded perspective view of the sterilization cap.

[0078] Figure 9 is Figure 7 An exploded cross-sectional view of the sterilization cap.

[0079] Figure 10 is a perspective view of a plug of a sterilization cap that may include as shown in Figures 2 to 9 according to another aspect of the present disclosure.

[0080] Figure 11A is Figure 7 A cross-sectional view of the sterilization cap and the open female Luer connector just before the open female Luer connector is inserted into the cap.

[0081] Figure 11B is Figure 7 A cross-sectional view of the sterilization cap and the open female Luer connector after the open female Luer connector is partially inserted into the cap.

[0082] Figure 12 A cross-sectional view of another example of a sterilization cap connected to an open female Luer connector according to another aspect of the present disclosure.

[0083] Figure 13 is Figure 12 An exploded perspective view of the cap.

[0084] Figure 14 is Figure 12 An exploded cross-sectional view of the cap.

[0085] Figure 15 is Figure 12 A cross-sectional view of the cap with the open female Luer connector partially inserted into the cap.

[0086] Figure 16 is Figure 12 A cross-sectional view of the cap with the open female Luer connector more fully inserted into the cap.

[0087] Figure 17 A cross-sectional view of another example of a sterilization cap connected to an open female Luer connector according to another aspect of the present disclosure.

[0088] Figure 18 is Figure 17 An exploded perspective view of the cap.

[0089] Figure 19 is Figure 17 An exploded cross-sectional view of the sterilization cap.

[0090] Figure 20A is Figure 17 A cross-sectional view of the cap, wherein the female luer connector is in the state just before the female luer connector is inserted into the cap.

[0091] Figure 20B is Figure 17 A cross-sectional view of the cap, wherein the female luer connector is partially inserted into the cap. DETAILED DESCRIPTION

[0092] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.

[0093] For the purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and their derivatives shall be related to the orientation of the invention in the accompanying drawings. The term "proximal" refers to the part of the device or component that is grasped by the user or connected to another device or component. The term "distal" refers to the part of the device or component that is opposite the proximal part (i.e., the part that is farthest from the part grasped by the user or connected to another component). For example, for an implantable medical device such as a catheter, the proximal part may refer to the part of the catheter that remains outside the patient's body and is manipulated by the user. The distal part of the catheter may be the part inserted into the patient's vasculature. For an object or component, such as an elongate member, the proximal end may be the end connected to another object or component. The distal end of the elongate member is opposite the proximal end and may not be connected to other objects or components. However, it should be understood that the invention may take alternative variations and step sequences, unless expressly stated to the contrary. It should also be understood that the specific devices and methods shown in the drawings and described in the following specification are merely exemplary embodiments of the invention. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0094] The present disclosure relates to a disinfection cap 10 configured to be connected to a female luer connector 112, such as a female luer connector for an access seat, port, or valve of a VAD, to prevent the connector, port, or VAD from being contaminated by, for example, microorganisms, debris, or other contaminants. In some examples, the cap 10 may be configured to clean or disinfect a portion of the connector 112, thereby ensuring that the connector 112 remains sterile prior to use. The cap 10 may be configured to remain in place on the connector 112 for at least seven days, which is the maximum recommended use time allowed by the sterile practice guidelines of many healthcare institutions.

[0095] The cap 10 is a sterilization cap for an open female Luer connector 112, and the sterilization cap is configured to engage or connect with connectors 112 of different sizes, configurations, and / or types. The open female Luer connector 112 may include an elongated distal portion 114 and an open distal end 116 having a diameter greater than the distal portion 114, wherein a tapered lumen 118 extends from the distal portion 114 through the center of the connector 112 to the open distal end 116. Engaging structures such as threads or Luer lugs 120 may extend from the outer surface of the open distal end 116. FIG. 1 shows an exemplary open female Luer connector 112 according to the prior art.

[0096] Sterilization cap for an open female Luer connector

[0097] Figures 2 - 6C Shows a portion of an exemplary sterilization cap 10 that is configured to engage and / or connect to an open female Luer connector 112 having different shapes, sizes, dimensions, or configurations. Specifically, Figure 2 Is a cross-sectional view of the cap 10 connected to the open female Luer connector 112. Figure 3 Is an exploded view of the cap 10. Figure 4 Is an exploded cross-sectional view of the cap 10. Figure 5 Is a perspective view of the bellows and plug of the cap 10. Figure 6A Is an exploded cross-sectional view of the cap 10 and the open female Luer connector 112 before insertion. Figure 6B Is a perspective view showing the open female Luer connector 112 inserted into the sterilization cap 10. Figure 6C Is a cross-sectional view showing the open female Luer connector 110 inserted into the sterilization cap 10.

[0098] In some examples, the cap 10 may be provided as a single pre-packaged cap or as a cap assembly as shown in the exploded view of Figure 3 . Further, as described in detail herein, the cap 10 includes components such as an absorbent support or sponge and / or a cleaning or sterilization solution for cleaning and sterilizing the portion of the open female Luer connector 112 that is inserted into and mounted to the cap 10.

[0099] As in Figures 2 - 6CAs shown, the cap 10 includes a rigid cap or housing 12, which includes an open first end or top 14, a second end or bottom 16, and a sidewall 18 that extends between the top 14 and the bottom 16 to form a cavity 19. The rigid cap 12 can be constructed of plastic. The cap 10 also includes an absorbent support 20, which in some examples can include a sponge 20 that is encapsulated by a bellows 30 and a plug 40 and is disposed within a recess or cavity 19 of the rigid cap 12. The absorbent support or sponge 20 can be a cylindrical member sized to fit within the bellows 30 and the cap 40, which are sized to fit within the recess or cavity 19 of the rigid cap 12. The rigid cap or housing 12 also includes threads 17 disposed on an inner surface of the sidewall 18, which are configured to engage threads or luer lugs 120 on an open female luer connector 112 for retaining the connector 112 within the rigid cap or housing 12.

[0100] The absorbent support or sponge 20 includes a disinfectant, such as IPA, for cleaning a distal portion 116 of the open female luer male connector 112 when the connector 112 is engaged to the cap 10. The absorbent support or sponge 20 can be constructed of an open-cell structure to retain the IPA and release the IPA when compressed by the entering open female luer connector 112 when the entering open female luer connector 112 engages the cap 10 (or more specifically, when the threads or luer lugs 120 on the open female luer connector 112 engage the threads 17 on the rigid cap or housing 12).

[0101] The absorbent support or sponge 20 can be disposed within the bellows 30. The bellows 30 can include a tubular structure having a lateral body 32 with an open top end 31 and an open bottom end 33, and the tubular structure also includes a plurality of holes, openings, slits, or slots 34 located on the lateral body 32 (as Figures 3 - 5As shown in one example in [description], the multiple holes, openings, incisions, or slits allow the disinfectant or IPA to move out of the sponge 20 into the recess or cavity 19 between the corrugated tube 30 and the inner surface of the sidewall 18 of the rigid cap or housing 12. The lateral body 32 of the corrugated tube 30 may include multiple ridges 36 and grooves 38, which may be compressed or deformed when the open female Luer connector 112 engages with the threads 17 on the rigid cap or housing 12, and thus apply a downward force to the corrugated tube 30 and the sponge 20. The corrugated tube 30 may be made of a thermoplastic polymer or an elastomer, silicone, rubber, or other similar materials. The corrugated tube 30 and the sponge 20 may be bonded to the inner surface of the bottom 16 of the rigid cap 12. The size and configuration of the multiple ridges 36 and grooves 38 on the corrugated tube 30 may be designed to fit within the threads 17 on the inner surface of the sidewall 18 of the rigid cap 12 to help hold the corrugated tube 30 and thus the sponge 20 within the rigid cap 12. When the open female Luer connector 112 engages with the threads 17 on the rigid cap or housing 12 and thus applies a downward force to the corrugated tube 30 and the sponge 20 causing the corrugated tube 30 to be compressed or deformed, the multiple ridges 36 and grooves 38 on the corrugated tube 30 may align with and press against the threads 17 on the inner surface of the sidewall 18 of the rigid cap 12, thereby pushing the disinfectant or IPA out of the sponge 20 and onto the threads 17 and into the recess 19 within the rigid cap 12 to further assist in cleaning and disinfecting the open female Luer connector 112.

[0102] The cap 10 may further include a plug 40, which may be in the shape of a disk as shown in Figures 2 to 5 and Figures 7 to 10 The plug 40 may act as a sealing element to seal or block the lumen 108 of the open female Luer connector 112 to restrict or prevent the disinfectant or IPA from entering the lumen 108 and thus into the fluid path of the open female Luer connector 112 and the VAD. As shown in Figure 10 The plug may consist of a first disk 42 with a smaller diameter, which is formed or connected to a second disk 44 with a larger diameter. The second disk is configured such that the first disk 42 can be inserted into the lumen 118 of the open female Luer connector 112 while the outer top surface 46 of the second disk 44 with a diameter larger than the first disk 42 can press against the open distal end 116 and / or the distal side 119 of the open female Luer connector 112 or seal the open distal end 116 and / or the distal side 119 of the open female Luer connector 112, as shown in Figure 2 and Figure 7As shown. In some examples, the plug 40 may further include a plurality of holes or openings 48 disposed on the outer top surface 46 of the second disc 44 to allow a disinfectant or IPA to contact the distal surface 119 of the female luer connector 112 of the opening. The plug 40 may be connected or joined to a portion of the bellows 30 or formed as a part of the bellows 30 at the top open end 31 of the bellows 30 so as to at least partially enclose or seal the top open end 31 of the bellows 30. The bellows 30 formed or connected with the plug 40 defines a recess or cavity in which the sponge 20 may be disposed.

[0103] The absorbent support or sponge 20, bellows 30 and other components of the cap 10 of the present disclosure may be configured to allow a cleaning solution to contact multiple areas of the female connector 112 of the opening, thereby ensuring that multiple areas of the female connector 110 of the opening remain sterile and free of microorganisms, contaminants, particles and other debris. In particular, the cap 10 may be configured to ensure that the cleaning solution contacts not only the outer surface (including threads or luer lugs 120) of the distal end 116 of the female luer connector 110 of the opening, but also the distal surface 119 of the female luer connector 112 of the opening. IPA may be filled in the cap 10 and retained in the sponge 20 to act as a disinfectant.

[0104] In some examples, the rigid cap or housing 12 is a molded component formed by injection molding or other common molding processes. In some examples, the rigid cap or housing 12 may be made of a rigid thermoplastic polymer material such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene. Additionally, the rigid cap or housing 12 may be formed of a durable material such as a material having a Shore hardness D value less than or equal to 95 (Shore D). Alternatively, the rigid cap or housing 12 may be formed of a more flexible material such as a material having a Shore hardness A value less than or equal to 130 (Shore A). Advantageously, the flexible housing 12 or a housing 12 including a flexible portion may be capable of stretching, bending or otherwise deforming such that the cap 10 can engage female luer connectors 112 of different sizes and shapes.

[0105] In some examples, the rigid cap or housing 12 further includes a protrusion, such as an axially extending rib or ridge 52, that extends outwardly from the outer surface of the sidewall 18 of the housing 12. The axial ridge 52 may be provided to increase the rigidity of the rigid cap 12 or housing 12 as compared to the case where no ridge 52 is present. Additionally, the ridge 52 may make the rigid cap or housing 12 easier to grasp and manipulate, thereby improving the usability of the cap 10, e.g., reducing the likelihood that a healthcare practitioner will drop the cap 10 or operate the cap 10 incorrectly during use.

[0106] As Figure 2Most clearly shown, the cap 10 further includes a sponge 20 and a bellows 30 disposed within the rigid cap or housing 12. As described in further detail herein, the sponge 20 and the bellows 30 are flexible, deformable, or compressible structures configured to be axially compressed when the open female luer connector 112 is inserted into the rigid cap 12. In particular, the sponge 20 and the bellows are configured to compress such that the distal end 116 of the open female connector 112 can be inserted further into the rigid cap or housing 12, thereby allowing the threads or luer lugs 130 of the connector 112 to contact and engage the threads 17 on the inner surface of the sidewall 18 of the rigid cap 12. In some examples, the sponge 20 can be an annular, cylindrical, or tubular structure having an outer diameter that substantially matches (e.g., is the same as or within about 5% or less deviation of) the inner diameter of the bellows 30 and is less than the inner diameter of the rigid cap or housing 12.

[0107] A plug 40 can be inserted into the lumen 108 of the open female luer connector 112 and can bear against the open distal end 116 and / or the distal face 119 of the open female luer connector 112, or seal the open distal end 116 and / or the distal face 119 of the open female luer connector 112, as Figure 2 and Figure 7 shown, which prevents the lumen 108 of the open female luer connector 112 from being contaminated.

[0108] In some examples, the sponge 20 includes a sponge or a porous foam (e.g., an open-cell foam) capable of absorbing a cleaning or disinfecting solution, such as a foam or a sponge. The sponge 20 can also include polyurethane or a thermoplastic elastomer, such as polypropylene, polyethylene, or a synthetic or natural rubber (e.g., isoprene). In other examples, the foam material can be a foam, which is a polymer foam designed and manufactured by Zotefoams PCL.

[0109] In some examples, the rigid cap 12 further includes a plurality of threads 17 extending radially inwardly from the sidewall 18 of the rigid cap 12. The threads 17 can be configured to engage the threads or luer lugs 130 on the distal end 116 of the open female luer connector 112 for securing the open female luer connector 112 to the rigid cap 12 and the cap 10. Thus, the open female luer connector 112 can be firmly held within the rigid cap 12 by thread engagement, thereby preventing the cap 10 from being inadvertently removed from the open female luer connector 112 at an undesired or inappropriate time.

[0110] As previously described, the sponge 20 holds a cleaning solution for cleaning and / or disinfecting the outer portion of the open female luer connector 112 that engages the cap 10. As Figure 2As shown, the sponge 20 can be set and held within a cylindrical inner space or cavity defined by the bellows 30, the plug 40, and the rigid cap 12. For example, the sponge 20 can be held in place within the bellows 30 by conventional adhesives or mechanical fasteners. In other examples, the sponge 20 can be held in place within the bellows 30 by friction between the inner surface of the bellows 30 and the outer surface of the sponge 20. The bellows 30 can be set and held within a cylindrical recess or cavity having an open end defined by the sidewall 18 and the bottom 16 of the rigid cap 12. The bellows 30 can be held in place within the rigid cap 12 by friction between the outer surface of the bellows 30 and the inner surface of the rigid cap. Specifically, the dimensions and configurations of the plurality of ridges 36 and grooves 38 on the bellows 30 can be designed to fit within the threads 17 on the inner surface of the sidewall 18 of the rigid cap 12 to assist in holding the bellows 30 and thus the sponge 20 within the rigid cap 12.

[0111] In some examples, the absorbent support or sponge 20 can be set (i.e., pre-soaked) with a cleaning or disinfecting solution. For example, the cleaning or disinfecting solution can be an antimicrobial, antifungal, antibacterial, or antiviral solution that cleans and sterilizes the outer surface of the female luer connector 112. In some examples, the cleaning solution can be isopropyl alcohol (IPA), such as approximately 70% IPA.

[0112] The absorbent support or sponge 20 and the bellows 30 can be configured to axially compress as the distal end 116 of the female connector 112 is inserted and moved through the interior of the cap 10 and the housing 12. The axial compression of the absorbent support or sponge 20 and / or the bellows 30 discharges the cleaning solution from the absorbent support or sponge 20. The discharged cleaning solution moves through the recess 19 of the rigid cap or housing 12 toward the open top 14 of the rigid cap 12, thereby contacting the outer surface 119 of the distal open end of the female luer connector 112 inserted into the rigid cap or housing 12. Once discharged from the absorbent support or sponge 20, the cleaning solution can pass through the openings (e.g., slots 34) in the bellows 30. After passing through the slots 34, the cleaning solution contacts other portions of the distal end 116 of the female luer connector 112 (e.g., the outer surface 119 and the threads or luer lugs 120). The cleaning solution can also pass through the opening 42 in the plug 40 such that the cleaning solution remains near the surfaces of the outer surface 119 of the female luer connector 112 and the threads or luer lugs 120 for cleaning and disinfecting these surfaces.

[0113] In some examples, the cap 10 further includes a plug 40 positioned in a recess 19 formed by the rigid cap or housing 12 and overlying the absorbent support or sponge 20. The plug 40 can be configured to prevent fluid (e.g., a cleaning or disinfecting solution absorbed by the absorbent support or sponge 20) from flowing into the lumen 118 of the open female luer connector 112.

[0114] The size and position of the plug 40 can be designed such that the cleaning solution discharged from the absorbent support or sponge 20 can move past the seal 44 toward the top 14 of the housing 12. As discussed previously, as the cleaning solution moves through the recess 19 formed by the rigid cap or housing 12, the cleaning solution contacts the outer surface 119 of the distal end 116 of the connector 112 for cleaning and disinfecting the outer surface. To allow the cleaning solution to move past the plug 40, the outer diameter 44 of the plug 40 can be greater than another portion 42 of the plug 40 and greater than the inner diameter of the lumen 118 of the connector 112 such that a hole or opening 48 in the outer diameter 44 of the plug 40 allows the cleaning solution to contact the outer surface 119 of the connector 112 while also preventing the cleaning solution from entering the lumen 118 and flow path of the open female connector 112.

[0115] Method for attaching a connector to a cap

[0116] As previously described, the cap 10 of the present disclosure is a disinfecting cap 10 configured to connect to open female luer connectors 112 of various types and sizes. Figure 2 Shown is the cap 10 connected to an open female luer connector 112 in one example.

[0117] To attach the cap 10 to the open female luer connector 112, a healthcare provider first removes any packaging from the cap 10. Once any packaging has been removed, the healthcare provider moves the connector 112 toward the open top 14 of the rigid cap or housing 12. Specifically, the distal open end 114 of the open female luer connector 112 is inserted through the open top 14 of the housing 12 such that the distal open end 114 of the open female luer connector 112 contacts the plug 40 disposed within the housing, such as as Figure 2 and Figure 6C shown. As Figure 2 and Figure 6CAs shown, as the distal open end 114 of the female luer connector 112 is inserted through the open top 14 of the housing 12, the threads or luer lugs 120 on the outer surface of the distal open end 114 of the female luer connector 112 contact the threads 17 of the rigid cap or housing 12. Additionally, the contact between the distal open end 114 of the female luer connector 112 and the plug 40 can block or seal the lumen 118 extending through the female luer connector 112, thereby preventing a cleaning solution or other fluid from entering the lumen 118 of the female luer connector 112.

[0118] To move the female luer connector 112 further into the rigid cap or housing 12 of the cap 10, the practitioner next rotates the female luer connector 112 relative to the cap 10 and the housing 12. The rotation of the female luer connector 112 relative to the housing 12 pulls the female luer connector 112 further down or into the cap 10, causing the distal open end 114 of the female luer connector 112 to move through the interior of the rigid cap or housing 12. As the distal open end 114 of the female luer connector 112 moves through the rigid cap or housing 12, it presses against the plug 40, which in turn axially compresses the absorbent support or sponge 20, thereby discharging the cleaning solution from the absorbent support or sponge into the interior of the rigid cap or housing 12, including in some examples discharging through the openings or slots 34 in the bellows 30 into the interior of the rigid cap or housing 12.

[0119] In some examples, the cleaning solution can move from the absorbent support or sponge 20 past the plug 40 and / or through the holes or openings 48 in the plug 40 and toward the open top 14 of the rigid cap or housing 12. As the cleaning solution is pushed through the rigid cap or housing 12, the cleaning solution can also pass through the holes or openings 42 in the plug 40 such that the cleaning solution contacts the outer surface 119 of the female luer connector 112 and the surface of the threads or luer lugs 120 for cleaning and disinfecting these surfaces.

[0120] The plug 40 can be positioned within the recess 19 formed by the rigid cap or housing 12 and above the absorbent support or sponge 20 between the distal open end 114 of the female luer connector 112 and the absorbent support or sponge 20. The plug 40 can be configured and positioned to prevent fluid (e.g., a cleaning or disinfecting solution absorbed by the absorbent support or sponge 20) from flowing into the lumen 118 of the female luer connector 112. Specifically, the top portion 42 of the plug 40 is advanced into the lumen 118 through the distal open end 116 of the female luer connector 112, thereby closing or sealing the lumen 118 through a friction fit, for example, between the inner wall of the lumen 118 and the outer surface of the top portion 42 of the plug 40.

[0121] The distal open end 116 of the female luer connector 112 continues to move into the rigid cap or housing 12 such that the female luer connector 112 bears against the cap 40 which in turn bears against and compresses the absorbent support 20 or sponge. The absorbent support or sponge 20 may also bulge radially outwardly such that it is pushed into the lateral body 32 of the bellows 30 which in turn may bulge radially outwardly until it contacts the inner surface of the side wall 18 of the rigid cap or housing 12. The cleaning solution from the absorbent support or sponge 20 may also enter the recess 19 defined by the interior of the rigid cap or housing and pass through the cut or slit 34 in the lateral body 32 of the bellows 30 towards the female luer connector 112 for cleaning and disinfecting the distal end 118 of the female luer connector 112.

[0122] To remove the cap 10 from the female luer connector 112, the practitioner first rotates the female luer connector 112 relative to the rigid cap or housing 12 such that the threads or luer lugs 120 of the female luer connector 112 are withdrawn from the threads 17 on the inner surface of the side wall 18 of the rigid cap or housing 12. The rotation of the female luer connector 112 relative to the rigid cap or housing 12 causes the female luer connector 118 to begin to move axially upwardly out of the housing 12.

[0123] Once the threads or luer lugs 120 of the female luer connector 112 are released from the threads 17 on the inner surface of the side wall 18 of the rigid cap or housing 12, the practitioner can pull the female luer connector 112 away from the rigid cap or housing 12, thereby releasing the female luer connector 112 from the cap 10. For example, the practitioner may grasp the rigid cap or housing 12 of the cap 10 with one hand and grasp the female luer connector 112 with the other hand. The practitioner then pulls the female luer connector 112 away from the cap 10 to remove the female luer connector 112 from the cap 10. Once removed, the cap 10 can be discarded as it is typically a single-use disposable product.

[0124] Once the female luer connector 112 is completely removed from the rigid cap or housing 12, the female luer connector 112 can be connected to the VAD.

[0125] Sterilization cap with a disk-based plug

[0126] Figures 7 - 9 and Figures 11A - 11B Another exemplary sterilization cap 210 for a female luer connector 110 incorporating features of the present disclosure is shown. Specifically, Figure 7 A cross-sectional view of the cap 210 is shown which includes a rigid cap or housing 12, an absorbent support or sponge 20, and a plug 40. Figure 8 An exploded view of the cap 210 is shown.Figure 9 A cross-sectional view of the cap 210 is shown. Figure 11A A cross-sectional view of the cap 210 and open female Luer connector 112 is shown prior to inserting the connector 112 into the cap 210. Figure 11B The open female Luer connector 112 is shown fully inserted into the cap 210.

[0127] The rigid cap or shell 12 of the cap 210, the absorbent support or sponge 20, and the plug 40 are constructed similarly to, for example, Figure 2 The cap 210 is the same as described in the previous example shown, except that the cap 210 does not include the bellows 40. Therefore, the cap 210 includes a shell 12 having an open first end or top 14, a second end or bottom 16, and a side wall 18 extending between the top 14 and the bottom 16. The cap 210 also includes an absorbent support or sponge 20 disposed in the rigid cap or shell 12. In addition, the cap 210 includes a plug 40 that is configured to prevent a cleaning solution used to clean and / or disinfect a portion of the open female connector 112 from being able to enter or flow into the lumen 118 of the connector 112 as the connector 12 is engaged to the cap 210. The plug 40 for the cap 210 can be as shown. Figure 10 The disc-based plug 40 is shown as previously described.

[0128] like Figures 11A - 11B As shown, in one example of a cap 210, the plug 40 is axially aligned with and disposed above the top of the absorbent support or sponge 20 and positioned within the recess 19 of the rigid cap or shell 12. The plug 40 may be configured to include Figure 10 The bottom disc portion 44 shown has an inner diameter greater than the outer diameter of the absorbent support or sponge 20 so that the cap fits over and over the top of the absorbent support or sponge 20, as shown in FIG. Figures 11A - 11B The sponge 20 may be held in place within the housing 12 by conventional adhesives or mechanical fasteners and may be bonded or attached to the inner surface of the bottom 16 of the rigid cap 12. In other examples, the sponge 20 may be disposed and retained within an open-ended cylindrical recess or cavity 19 defined by the sidewall 18 and bottom 16 of the rigid cap 12, including by friction fit with the sidewall 18 of the rigid cap or housing 12 and / or threads 17 on the sidewall 18 if the outer diameter of the absorbent support or sponge 20 is large enough.

[0129] Similar to the previous example, the rigid cap 12 of the cap 210 also includes a plurality of threads 17 that radially extend inwardly from the sidewall 18 of the rigid cap 12. The threads 17 can be configured to engage with the threads or luer lugs 130 on the distal end 116 of the female luer connector 112 to fix the female luer connector 112 to the rigid cap 12 and the cap 10. The absorbent support or sponge 20 can be configured to axially compress as the distal end 116 of the female connector 112 is inserted and moved through the interior of the cap 210 and the housing 12. The axial compression of the absorbent support or sponge 20 discharges the cleaning solution from the absorbent support or sponge 20. The discharged cleaning solution moves through the recess 19 of the rigid cap or housing 12 towards the open top 14 of the rigid cap 12, thereby contacting the outer surface 119 of the distal open end of the female luer connector 112 inserted into the rigid cap or housing 12. The cleaning solution can also pass through the holes or openings 48 in the plug 40, such that the cleaning solution remains near the outer surface 119 of the female luer connector 112 and the surface of the threads or luer lugs 120 for cleaning and disinfecting these surfaces. Thus, the holes 48 on the top surface 46 of the disc-shaped plug 40 allow IPA to contact the distal surface 119 of the female luer connector 112 and disinfect the surface 119.

[0130] In some examples, the cap 210 further includes a plug 40 that is positioned in the recess 19 formed by the rigid cap or housing 12 and above the absorbent support or sponge 20. The plug 40 can be configured to prevent fluid (e.g., the cleaning or disinfecting solution absorbed by the absorbent support or sponge 20) from flowing into the lumen 118 of the female luer connector 112.

[0131] The size of the plug 40 can be designed and the plug can be positioned in the housing 12 of the cap 210 such that the cleaning solution discharged from the absorbent support or sponge 20 can move through the plug 40 towards the top 14 of the housing 12. As discussed above, as the cleaning solution moves through the recess 19 formed by the rigid cap or housing 12, the cleaning solution contacts the outer surface 119 of the distal end 116 of the connector 112 for cleaning and disinfecting the outer surface. To allow the cleaning solution to move through the plug 40, the outer diameter 44 of the plug 40 can be greater than another portion 42 of the plug 40 and greater than the inner diameter of the lumen 118 of the connector 112, such that the holes or openings 48 in the outer diameter 44 of the plug 40 allow the cleaning solution to contact the outer surface 119 of the connector 112 while also preventing the cleaning solution from entering the lumen 118 and the flow path in the female connector 112.

[0132] Disinfection Cap with Coaxial Cylindrical Plug

[0133] Figures 12 - 16Another example of a cap 310 incorporating features of the present disclosure is shown, where the cap 310 includes a plug 340 that extends the entire length of a sponge 320, and the sponge is in the form of an annular cylinder that fits around the plug 340. Specifically, Figure 12 is a cross-sectional view of the cap 310 showing the female luer connector 112 with an opening and the cap 310 after the connector 112 is inserted into the cap 310. Figure 13 is an exploded perspective view of the cap 310, which includes a rigid cap or housing 12, a coaxial cylindrical plug 340, and a tubular absorbent support or sponge 320. The rigid cap or housing 12 is configured as in the example described previously in connection with the Figure 2 cap 12 shown. Thus, the cap 310 includes a housing 12 that includes an open first end or top 14, a closed second end or bottom 16, and a sidewall 18 that extends between the top 14 and the bottom 16. The cap 310 also includes an absorbent support or sponge 320 disposed within the housing 12, the absorbent support or sponge being tubular and defining a cylindrical recess or opening 322 into which the coaxial cylindrical plug 340 can be inserted. The rigid cap or housing 12 is configured to engage with the female luer connector 112 with an opening for holding the female luer connector 112 with an opening within the housing 12. The absorbent support or sponge 320 disposed within the rigid cap or housing 12 and configured to surround the coaxial cylindrical plug 340 is configured to receive a cleaning solution for cleaning and / or disinfecting the portion of the female luer connector 112 with an opening that engages with the cap 310.

[0134] The absorbent support or sponge 320 can be made of the same material and configured to operate in the same manner as described previously with respect to the absorbent support or sponge 20. The absorbent support or sponge 320 can include a disinfectant, such as IPA, for cleaning the distal portion 116 of the male luer connector 112 with an opening when the connector 112 engages with the cap 310. The absorbent support or sponge 320 can be constructed of an open-cell structure to retain the IPA and release the IPA when the absorbent support or sponge 320 is compressed by the entering female luer connector 112 with an opening as it engages with the cap 310, or more specifically, when the threads or luer lugs 120 on the female luer connector 112 with an opening engage with the threads 17 on the rigid cap or housing 12. The absorbent support or sponge 320 can be configured to axially compress as the distal end 116 of the female connector 112 is inserted and moved through the interior of the cap 310 and the housing 12. Specifically, as Figure 16As shown, the absorbent support or sponge 320 can be configured to directly contact the bottom surface 119 and the threads or luer lug 120 of the open distal end 116 of the open female luer connector 112. Axial compression of the absorbent support or sponge 320 expels the cleaning solution from the absorbent support or sponge 320 such that the cleaning solution can contact the bottom surface 119 and the threads or luer lug 120 of the open distal end 116 of the open female luer connector 112 and other portions of the outer surface of the distal end 116 of the open female luer connector 112 and thereby clean and disinfect the bottom surface 119 and the threads or luer lug 120 of the open distal end 116 of the open female luer connector 112 and other portions of the outer surface of the distal end 116 of the open female luer connector 112.

[0135] As Figures 13 - 16 shown, the plug 340 can include a first top solid cylindrical member 342 that is connected to or forms with a second bottom solid cylindrical member 344, wherein the outer diameter of the first top solid cylindrical member 342 is less than the outer diameter of the second bottom solid cylindrical member 344. Accordingly, the diameter of the top solid cylindrical member 342 is sized to fit within the lumen 118 of the distal open end 116 of the open female luer connector 112 such that it can block or seal the lumen 118 to prevent entry of the cleaning solution or disinfecting solution or IPA. Accordingly, the second bottom solid cylindrical member 34 with the larger diameter can contact the bottom surface 119 and the threads or luer lug 120 of the distal open end 116 of the open female luer connector 112 at its outer top edge 345 such that it can also block or seal the lumen 118 to prevent entry of the cleaning solution or disinfecting solution or IPA, and support the open female luer connector 112 in place within the rigid cap or housing 12 and / or prevent further axial movement of the open female luer connector 112 into the recess 19 formed within the rigid cap or housing 12, as Figures 15 - 16 best shown.

[0136] As Figure 12 and 15As shown in FIGS. 15 and 16, as the distal end 116 of the female luer connector 112 is inserted into the open end 14 of the rigid cap or housing 12, the first top solid cylindrical member 342 of the plug 340 can be configured to extend further beyond the top of the absorbent support or sponge 320 such that the first top solid cylindrical member 342 of the plug 340 is inserted into the lumen 118 of the female luer connector 112, thereby blocking or sealing the lumen 118 before the distal end 116 of the female luer connector 112 contacts and thus compresses the absorbent support or sponge 320. Thus, by the axial compression of the absorbent support or sponge 320, the cleaning or disinfecting solution pushed out or extruded from the absorbent support or sponge 320 is prevented from entering the lumen 118.

[0137] Disinfection Cap with Hemispherical Plug

[0138] Figures 17 - 20B The cap 410 shown differs from the previous example in that: in addition to the rigid cap or housing 12 configured and shown in the previous example, the cap 410 further includes a hemispherical plug 440, a plug guide 450, and a coaxial absorbent support or sponge 420. The rigid cap or housing 12 can be configured as described in connection with the cap 12 shown in the previous example, e.g. Figure 2 The coaxial absorbent support or sponge 420 can be made of the same material and configured to operate in the same manner as previously described for the absorbent support or sponge 20. The plug 440 in this example is pushed down into the plug guide 450 by connecting the female luer connector 112 to the cap 410, but the plug 440 remains pressed against the distal face of the female luer connector 112 and its lumen 118.

[0139] As Figures 17 - 20B shown, the plug guide 450 includes an open first end or top 452, an open second end or bottom 454, and a side wall 456 extending between the top 452 and the bottom 454. The plug guide may further include an annular disc-shaped base 458 that extends from the outer surface of the side wall 456 of the plug guide 450 and is adjacent to the bottom 454 of the plug guide 450. The plug guide 450 can be part of the rigid cap or housing 12, fixed or connected to the rigid cap or housing 12, and in some examples can include a single molded plastic piece.

[0140] As Figures 18 - 20BAs shown, the hemispherical plug 440 includes a top hemispherical member 442, the top hemispherical member including a half sphere having a circular spherical top portion 444, a flat bottom portion 446, and a bottom cylindrical member 448, the bottom cylindrical member being connected to, formed integrally with, or molded onto the flat bottom portion 446 of the top hemispherical member 442. The bottom cylindrical member 448 is configured to be inserted into the first open end or top 452 of the plug guide 450. The bottom cylindrical member 448 may be fixed to the first open end or top 452 of the plug guide 450 or connected to the first open end or top 452 of the plug guide 450 via a friction fit. The construction and diameter of the top hemispherical member 442 and the spherical top portion 444 of the hemispherical plug 440 may be designed to fit within or conform to the lumen 118 of the distal open end 116 of the open female luer connector 112 such that it can block or seal the lumen 118 to prevent entry of cleaning or disinfecting fluid or IPA. The construction and dimensions of the bottom cylindrical member 448 may be designed to fit within the cylindrical opening 422 at the center of the absorbent support or sponge 420.

[0141] As Figures 18 - 20B shown, the absorbent support or sponge 420 may include a top open end 424, a bottom open end 426, and a sidewall 428 that forms or defines a tubular structure, wherein the cylindrical opening 422 extends through the middle of the absorbent support or sponge 420. The open top end 424 may have an opening 425 with a larger diameter than the cylindrical opening 422 to contact or support the flat bottom portion 446 of the hemispherical plug 440. The absorbent support or sponge 320 may be constructed of the same material and configured to operate in the same manner as previously described for the absorbent support or sponge 20.

[0142] The absorbent support or sponge 420 may include a disinfectant, such as IPA, for cleaning the distal portion 116 of the open male luer connector 112 when the connector 112 engages the cap 410. The absorbent support or sponge 420 may consist of an open cell structure to retain the IPA and release the IPA when the absorbent support or sponge 420 is compressed by the entering open male luer connector 112 when the entering open male luer connector 112 engages the cap 410, or more specifically, when the threads or luer lugs 120 on the open male luer connector 112 engage the threads 17 on the rigid cap or housing 12. The absorbent support or sponge 420 may be configured to be axially compressed as the distal end 116 of the male connector 112 is inserted and moved through the interior of the cap 310 and housing 12. Specifically, as Figure 17 and Figure 20BAs shown, the absorbent support or sponge 420 can be configured to directly contact the bottom surface 119 and the threaded or luer lug 120 of the open distal end 116 of the open female luer connector 112. Axial compression of the absorbent support or sponge 420 discharges the cleaning solution from the absorbent support or sponge 320 such that it can contact and thus clean and disinfect the bottom surface 119 and the threaded or luer lug 120 of the open distal end 116 of the open female luer connector 112 and other portions of the outer surface of the distal end 116 of the open female luer connector 112.

[0143] As Figure 17 and Figures 20A - 20B shown, as the distal end 116 of the open female luer connector 112 is inserted into the open end 14 of the rigid cap or housing 12, the top hemispherical member 442 of the hemispherical plug 440 having the rounded spherical top portion 444 can be configured to further extend beyond the top 424 of the absorbent support or sponge 420 such that the top hemispherical member 442 of the hemispherical plug 440 having the rounded spherical top portion 444 is inserted into the lumen 118 of the open female luer connector 112, thereby blocking or sealing the lumen 118 before the distal end 116 of the open female luer connector 112 contacts and thus compresses the absorbent support or sponge 420. Accordingly, the cleaning or disinfecting solution pushed or extruded from the absorbent support or sponge 420 by axial compression thereof is prevented from entering the lumen 118.

[0144] Plugs for the Disinfection Caps

[0145] As previously described, the plugs 40, 340, 440 for the disinfection caps 10, 210, 310, 410 disclosed herein are each configured to block or seal the lumen 118 of the open female luer connector 112 using an interference fit. The plugs 40, 340, and 440 are configured and positioned within the disinfection caps 10, 210, 310, 410 to reduce the chance of disinfectant or IPA entering the lumen 118 of the open female luer connector 112.

[0146] Although the examples of the disinfection caps 10, 210, 310, 410 and their methods of use described in this disclosure have been shown in the drawings and described in detail above, other examples will be apparent to and can be readily made by those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative rather than limiting. The invention as described above is defined by the appended claims, and all changes made within the meaning and equivalents of the claims are covered within the scope of the claims.

Claims

1. A disinfection cap configured to engage with an open female Luer connector including a lumen, the disinfection cap comprising: a housing including an open first end, a second end, and at least one sidewall extending between the first end and the second end to define a recess; a plug disposed in the recess of the housing, the plug configured to engage with the open female Luer connector to seal the lumen of the open female Luer connector; and an absorbent support disposed in the recess of the housing, the absorbent support configured to hold a cleaning solution for cleaning and / or disinfecting a portion of the open female Luer connector that engages with the disinfection cap.

2. The disinfection cap according to claim 1, wherein The absorbent support includes a sponge.

3. The disinfection cap according to claim 1, wherein, The cleaning solution includes at least one of isopropyl alcohol (IPA), chlorhexidine, and povidone iodine.

4. The disinfection cap according to claim 1, wherein, When the open female Luer connector engages with the disinfection cap, the cleaning solution is exposed to a portion of the open female Luer connector for cleaning and / or disinfecting the open female Luer connector.

5. The disinfection cap according to claim 1, wherein The open female Luer connector further includes an outer surface and threads extending from the outer surface, and the sidewall of the housing further includes an inner surface including threads to engage with the threads on the outer surface of the open female Luer connector.

6. The disinfection cap according to claim 1, wherein, The disinfection cap further includes a bellows including a first open end, a second open end, and a sidewall defining a cylindrical opening configured to enclose the absorbent support, wherein the first open end of the bellows is configured to connect to the plug to further enclose the absorbent support.

7. The disinfection cap according to claim 6, wherein, The bellows further includes: a sidewall including ridges and grooves configured to be compressed; and a plurality of openings in the sidewall, the plurality of openings in the sidewall configured to allow the cleaning solution to flow from the absorbent support into the recess formed by the housing to clean and disinfect a portion of the open female Luer connector when the absorbent support is compressed by inserting the open female Luer connector into the disinfection cap.

8. The disinfection cap according to claim 7, wherein, The cleaning solution includes at least one of isopropyl alcohol (IPA), chlorhexidine, or povidone iodine, and the absorbent support includes a sponge.

9. The disinfection cap according to claim 1, wherein, The plug includes a first disk configured to fit within the lumen of the open female Luer connector and seal the lumen.

10. The disinfection cap according to claim 9, wherein, The plug further includes a second disk having a larger diameter than the first disk and connected to the first disk, wherein the second disk includes a plurality of holes for allowing the cleaning solution to pass through the plug toward the first end of the opening of the housing.

11. The disinfection cap according to claim 1, wherein, The plug includes a hemispherical member configured to fit within the lumen of the open female Luer connector and seal the lumen.

12. The disinfection cap according to claim 11, wherein, The plug further includes a cylindrical member having a first end and a second end, the first end of the cylindrical member being fixed to the hemispherical member, and the second end of the cylindrical member being slidably engageable with a plug guide, the plug guide including a top open end for receiving the second end of the cylindrical member of the plug and a bottom second end connected to the second end of the housing.

13. The disinfection cap according to claim 12, wherein, The absorbent support includes an open top end, an open bottom end, and a sidewall, the sidewall of the absorbent support extending between the open top end and the open bottom end to define an inner cylindrical opening configured to receive and surround a portion of the plug.

14. The disinfection cap according to claim 1, wherein, The plug includes a cylindrical member, the cylindrical member including: a first end configured to fit within and seal the lumen of the open female luer connector; a second end having a diameter greater than the first end of the cylindrical member and the lumen configured to further engage the open female luer connector.

15. The disinfection cap according to claim 14, wherein, The absorbent support includes an open top end, an open bottom end, and a sidewall, the sidewall extending between the open top end and the open bottom end to define an inner cylindrical opening configured to receive and surround a portion of the second end of the plug.

16. The disinfection cap according to claim 1, wherein, Inserting the open female luer connector into the housing causes the absorbent support to be further axially compressed into the housing, and wherein axial compression of the absorbent support discharges the cleaning solution from the absorbent support such that the cleaning solution moves through the interior of the housing and contacts the outer surface of the open female luer connector inserted into the housing.

17. A method for attaching the disinfection cap according to claim 1 to the open female luer connector, the method comprising: Inserting a distal open end of the open female luer connector through a first end of the opening of the housing such that a proximal end of the open female luer connector contacts the absorbent support and a plug disposed in the housing; And Rotating the open female luer connector relative to the housing such that the proximal end of the open female luer connector advances through the housing and axially compresses the absorbent support.

18. A cap configured to engage an open female connector including a lumen, the cap comprising: A housing including an open first end, a second end, and at least one sidewall extending between the first end and the second end to define a recess; A bellows including an open first end, an open second end, and at least one sidewall extending between the first end and the second end of the bellows to define a cavity disposed in the recess defined by the housing; An absorbent support member disposed in the cavity defined by the bellows and received by the side walls of the bellows, the absorbent support member configured to hold a cleaning solution for cleaning and disinfecting a portion of the female connector that engages the cap; A plug connected to a first end of the opening of the bellows, the plug configured to further receive the absorbent support member and prevent the cleaning solution from entering the lumen of the female connector.

19. The cap according to claim 18, wherein, The absorbent support member includes a sponge, and the cleaning solution is a disinfectant, such as but not limited to isopropyl alcohol (IPA), chlorhexidine, and povidone iodine.

20. A cap configured to engage a female connector having a lumen, the cap comprising: A rigid housing including a first open end, a second end, and side walls extending between the first end and the second end to define a recess; A sponge disposed in the recess defined by the housing, the sponge configured to hold a cleaning solution including at least one of isopropyl alcohol (IPA), chlorhexidine, or povidone iodine for cleaning and disinfecting a portion of the female connector that engages the cap; A plug configured to be inserted into the lumen of the female connector to prevent IPA from entering the lumen of the female connector.

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