Sterilization cap for male and female connectors including a restraining lock

Abstract

A cap configured to engage different types of connectors includes a housing having an open first end, a second end, a sidewall extending between the first end and the second end, and an opening extending through the sidewall. The cap also includes a flexible sleeve disposed in the housing, the flexible sleeve having a first end, a second end, and a sleeve sidewall extending between the first end and the second end. The cap further includes a lock connected to the housing configured to move through the opening of the housing to press against the sleeve sidewall, which causes the sleeve sidewall to directly or indirectly press against a portion of a connector to secure the connector in the housing, and an absorbent member disposed in the flexible sleeve configured to contain a cleaning solution for cleaning and / or disinfecting a portion of the connector engaged with the cap.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Patent Application No. 17 / 994,929, filed November 28, 2022, entitled “Disinfecting Cap for Male and Female Connectors Including a Constricting Lock,” the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to caps for medical connectors, and in particular, to a medical cap configured to attach to a male or female connector for sealing, cleaning, and sterilizing a portion of the connector. Background Technology

[0004] Vascular access devices (VADs) are commonly used medical devices that can include intravenous (IV) catheters, such as peripheral or central venous catheters. If not properly maintained or exposed to a non-sterile environment, VADs can become contaminated, sealed with blood clots, and / or potentially spread infection. Furthermore, bacteria and other microorganisms can enter a patient's vascular system from the access seat, port, or valve when connected to the VAD to deliver fluids or medications. Therefore, each access seat, port, valve, or other connection configured to attach to a VAD is associated with some risk of transmitting catheter-related bloodstream infection (CRBSI) to the patient.

[0005] Many healthcare facilities implement aseptic practices and protocols to ensure that VADs and access ports are used correctly and are not sealed or contaminated. These protocols typically include sterilizing access ports, ports, and VADs, and flushing the catheter with a flushing solution before use. Specifically, VAD practice standards generally recommend flushing procedures after catheter placement, before infusion, and before and after administration of medication, blood draws, transfusions, and / or parenteral nutrition. Practice standards may also require that access ports, ports, and valves be capped with sterile caps when not in use to prevent microbial entry into the ports or valves, and that areas that come into contact with the VAD's ports, ports, or valves be sterilized. A sterile cap is a disposable cap device that contains a certain amount of cleaning or disinfecting solution to sterilize parts of the ports, ports, and valves.

[0006] Access ports and sockets can have various types of male or female connectors for securing the port or socket to the VAD. Currently, practitioners often carry multiple types of caps so they can cover different types of ports and sockets, each suitable for specific patients. For example, caps for male and female needleless connectors, as well as caps for intravenous (IV) lines and hemodialysis lines, typically use different connector designs and may require different caps. There may be a "male sterilization cap device" for sterilizing ISO 594-2 type female threaded fluid Luer connectors and a "female sterilization cap device" for sterilizing ISO 594-2 type male threaded fluid Luer connectors.

[0007] Examples of universal caps suitable for both male and female connectors are known. For example, U.S. Patent No. 10,871,246, entitled "Universal connector or cap for male and female threaded fittings," discloses a cap including threaded protrusions capable of engaging both male and female connectors; this U.S. patent is incorporated herein by reference in its entirety. However, there is a need for a simpler cap design that can be manufactured inexpensively and efficiently. The universal cap of this disclosure is configured to attach securely to both male and female medical connectors in a manner sufficient to prevent microbial intrusion. Furthermore, the universal cap of this disclosure is configured to be easily manufactured in a single-mold process. Summary of the Invention

[0008] According to one aspect of this disclosure, a cap configured to engage at least one first connector and one second connector of different types, the cap comprising a housing having an open first end, a second end, at least one sidewall extending between the first end and the second end, and at least one opening extending through the at least one sidewall. The cap further comprises a flexible sleeve disposed within the housing, the flexible sleeve having a first end, a second end, and a sleeve sidewall extending between the first end and the second end. The cap further comprises a lock connected to the housing, the lock being configured to move through the at least one opening of the housing to press against the sleeve sidewall, causing the sleeve sidewall to press directly or indirectly against a portion of the first connector or the second connector to secure the first connector or the second connector within the housing. The cap further comprises an absorbent member disposed within the flexible sleeve, the absorbent member being configured to contain a cleaning solution for cleaning and / or disinfecting the portion of the first connector or the second connector that engages with the cap.

[0009] According to one embodiment of the present invention, the first connector is a female connector and the second connector is a male connector.

[0010] According to one embodiment of the invention, the cap is sized to accommodate male and / or female connectors with different thread configurations and sizes.

[0011] According to one embodiment of the invention, the cap is sized to receive a female connector having threads with a crest width of about 0.3 mm to about 1.0 mm and a root width of about 0.5 mm to 1.2 mm.

[0012] According to one embodiment of the present invention, the first connector includes a female Luer connector and the second connector includes a male Luer connector.

[0013] According to one embodiment of the present invention, the inner surface of the flexible sleeve is a cylindrical surface without threads or grooves.

[0014] According to one embodiment of the invention, the absorbent member is configured to clean and / or disinfect the threaded surface of the first connector or the second connector.

[0015] According to one embodiment of the invention, a lock is configured to be attached to the housing to hold the lock against the flexible sleeve, thereby securing the first connector or the second connector in the housing.

[0016] According to one embodiment of the invention, a first portion of the lock is rotatably connected to the housing such that the lock rotates about the first portion toward the flexible sleeve in a first direction, and wherein a second portion of the lock is connected to the housing to prevent the lock from rotating away from the flexible sleeve in a second direction.

[0017] According to one embodiment of the present invention, the housing and lock comprise a rigid thermoplastic polymer having at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.

[0018] According to one embodiment of the invention, the housing further includes a tab, and wherein the lock is rotatably, slidably and / or pivotally connected to the tab.

[0019] According to one embodiment of the invention, the housing includes a plurality of ridges or ribs extending outward from the outer surface of the housing (for making the housing easier to grip).

[0020] According to one embodiment of the present invention, the flexible sleeve includes a thermoplastic elastomer having at least one of silicone resin, polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene).

[0021] According to one embodiment of the present invention, the outer diameter of the flexible sleeve is substantially matched with the inner diameter of the housing.

[0022] According to one embodiment of the invention, a first end of the sleeve includes an opening and a flange extending around the opening, wherein the flange rests against the first end of the opening of the housing.

[0023] According to one embodiment of the invention, the lock causes the sleeve to deform radially inward to directly or indirectly contact the portion of the first connector or the second connector.

[0024] According to one embodiment of the present invention, the first end of the sleeve is open, and the second end of the sleeve is closed.

[0025] According to one embodiment of the present invention, the inner diameter of the flexible sleeve is larger than the maximum outer diameter of the first connector or the second connector, such that the flexible sleeve does not obstruct the insertion of the first connector or the second connector into the housing.

[0026] According to one embodiment of the present invention, the housing further includes tabs.

[0027] According to one embodiment of the invention, the lock is rotatably engaged with the tab, such that the lock rotates relative to the tab to press against the flexible sleeve.

[0028] According to one embodiment of the invention, the tab of the housing further includes a slot, and wherein a portion of the lock is inserted into the slot to retain the lock in contact with the flexible sleeve.

[0029] According to one embodiment of the present invention, the lock includes: a proximal end connected to the tab of the housing; a distal end opposite to the proximal end; and a cam portion located between the proximal end and the distal end of the lock.

[0030] According to one embodiment of the present invention, the cam portion includes a concave inner surface and a convex outer surface, wherein rotation of the lock relative to the housing causes the convex outer surface of the cam portion to contact the flexible sleeve.

[0031] According to one embodiment of the invention, the distal end of the lock includes a handle configured for a user to grip and rotate the lock toward the flexible sleeve.

[0032] According to one embodiment of the invention, the proximal end of the lock includes a proximal post configured to insert into a hole in a tab located in the housing, thereby forming a rotation point for the lock to rotate relative to the housing.

[0033] According to one embodiment of the invention, the distal end of the lock includes a distal post extending therefrom, the distal post being configured to insert into a slot in a tab extending through the housing to hold the lock in a position against compression by a flexible sleeve.

[0034] According to one embodiment of the invention, by rotating the lock around the rotation point, the distal column moves through the slot and increases the pressure against the flexible sleeve.

[0035] According to one embodiment of the invention, the slot includes a plurality of protrusions configured to engage a distal post to retain the lock in a selected position relative to the flexible sleeve.

[0036] According to one embodiment of the invention, the lock applies a variable pressing force to the sleeve, which increases proportionally with the increase of the rotation angle of the lock relative to the housing.

[0037] According to one embodiment of the invention, the lock is connected to the housing in at least one of a slidable, pivotable, or rotatable manner.

[0038] According to one embodiment of the present invention, the pressing force of the lock on the flexible sleeve causes the first connector or the second connector to be held in a position within the flexible sleeve, where the longitudinal axis of the connector is offset from the longitudinal axis of the cap's housing.

[0039] According to one embodiment of the invention, a seal is disposed in the housing on the absorbent member to clean and disinfect the first or second connector when it is inserted into the housing.

[0040] According to one embodiment of the invention, the seal comprises a non-porous foam, such as a closed-cell foam.

[0041] According to one embodiment of the present invention, the absorbent component comprises a sponge.

[0042] According to one embodiment of the invention, the absorbent component comprises an open-cell foam, such as a porous foam having a thermoplastic elastomer.

[0043] According to one embodiment of the present invention, the insertion of a first connector or a second connector into the housing causes axial compression of the absorbent member.

[0044] According to one embodiment of the invention, axial compression of the absorbent member causes the cleaning solution of the absorbent member to contact the threads and surfaces of the first connector or the second connector.

[0045] According to one embodiment of the present invention, the cleaning solution is absorbed by an absorbent support.

[0046] According to one embodiment of the present invention, the cleaning solution comprises isopropanol (IPA).

[0047] According to one embodiment of the invention, the cleaning solution comprises about 0.5% to about 3.5% chlorhexidine gluconate and about 70% IPA.

[0048] According to one embodiment of the present invention, a protective cover is located on the first end of the opening of the housing.

[0049] According to one embodiment of the present invention, the protective cover is attached to the housing by heat sealing.

[0050] According to one embodiment of the invention, a flange extends around an opening at a first end of a flexible sleeve and is positioned between the first ends of the openings of the cover and the housing.

[0051] According to another aspect of the disclosure, a method for attaching the aforementioned cap to a first connector or a second connector includes: inserting the distal end of the first connector or the second connector through a first end of an opening in a housing and a first end of a flexible sleeve. The method further includes: applying axial pressure to the connector, causing axial compression of an absorbent member and further movement of the distal end of the connector into the flexible sleeve; and moving a portion of the lock through at least one opening in at least one sidewall of the housing, thereby directly or indirectly pressing the flexible sleeve against the connector to secure the connector within the housing.

[0052] According to one embodiment of the invention, the method further includes: inserting the distal end of a first connector or a second connector through a first end of an opening in the housing and a first end of a flexible sleeve, and applying axial pressure to the connector, causing the absorbent member to compress axially and moving the distal end of the connector further into the flexible sleeve; and moving a portion of the lock through at least one opening in at least one sidewall of the housing, thereby directly or indirectly pressing the flexible sleeve against the connector to secure the connector within the housing.

[0053] According to one embodiment of the invention, inserting the connector into the housing includes inserting the connector through a first end of the housing opening and a first end of the flexible sleeve, but without rotating or turning the connector relative to the flexible sleeve.

[0054] According to one embodiment of the present invention, the first connector is a female connector and the second connector is a male connector.

[0055] According to one embodiment of the invention, the housing further includes a tab, wherein the lock is rotatably engaged with the tab such that the lock rotates relative to the tab to resist compression against the flexible sleeve.

[0056] According to one embodiment of the invention, the tab of the housing further includes a slot, and wherein a portion of the lock is inserted into the slot to retain the lock in contact with the flexible sleeve.

[0057] According to one embodiment of the present invention, the lock includes: a proximal end connected to a tab of a housing; a distal end opposite to the proximal end; and a cam portion located between the proximal end and the distal end of the lock.

[0058] According to one embodiment of the invention, the distal end of the lock includes a handle configured to be gripped by a user, wherein the user grips the handle to move the lock through at least one opening in at least one side wall of the housing.

[0059] According to one embodiment of the invention, the distal end of the lock includes a distal post extending therefrom, and the method further includes inserting the distal post of the lock into a slot in the tab to hold the lock in a position against compression from the flexible sleeve.

[0060] According to one embodiment of the invention, the method further includes removing a protective cap located on the first end of the opening of the housing before inserting the distal end of the first connector or the second connector through the first end of the opening of the housing.

[0061] According to another aspect of the disclosure, a cap includes a housing having an open first end, a second end, at least one sidewall extending between the first and second ends, at least one opening extending through the at least one sidewall, and a tab extending outwardly from the at least one sidewall of the housing. The tab includes a hole and a slot. The cap also includes a lock and a flexible sleeve disposed within the housing, the flexible sleeve having a first end, a second end, and a sleeve sidewall extending between the second and first ends. The lock includes: (i) a proximal post inserted into the hole of the tab to provide rotational engagement between the lock and the tab; and (ii) a distal post configured to be inserted into the slot of the tab to prevent rotation of the lock relative to the tab. The cap also includes an absorbent member disposed within the flexible sleeve, the absorbent member being configured to contain a cleaning solution for cleaning and / or disinfecting portions of a first or second connector that engage with the cap.

[0062] According to one embodiment of the invention, the cap is configured to receive a connector, and wherein, when the connector is inserted into the housing, a lock is moved in a first direction to press against a flexible sleeve, thereby securing the connector to the housing.

[0063] According to one embodiment of the invention, the cap is configured to receive different types of connectors, such as male connectors and female connectors.

[0064] According to one embodiment of the invention, the cap is configured to receive connectors with different sizes and different thread configurations.

[0065] According to one embodiment of the invention, the lock includes a proximal end having a proximal post, a distal end opposite the proximal end, and a cam portion located between the proximal end and the distal end of the lock.

[0066] According to one embodiment of the present invention, the cam portion includes a concave inner surface and a convex outer surface, wherein rotation of the lock relative to the housing causes the convex outer surface of the cam portion to contact the flexible sleeve.

[0067] According to one embodiment of the invention, the distal end of the lock includes a handle configured for a user to grip and rotate the lock toward a flexible sleeve.

[0068] According to one embodiment of the invention, the slot includes a plurality of protrusions configured to engage a distal post to retain the lock in a selected position relative to the flexible sleeve. Attached Figure Description

[0069] Figure 1A This is a cross-sectional view of an exemplary male connector as known in the prior art.

[0070] Figure 1B Examples of enclosed female connectors, as known in the prior art, include a diaphragm with slits.

[0071] Figure 2A This is a perspective view of a general cap according to one aspect of this disclosure, wherein the lock of the cap is in the open position.

[0072] Figure 2B yes Figure 2A A perspective view of the cap, with the lock in the closed position.

[0073] Figure 2C yes Figure 2A A perspective view of the cross-section of the cap.

[0074] Figure 3 yes Figure 2A An exploded perspective view of the hat.

[0075] Figure 4A yes Figure 2A A bottom view of the hat, with the lock in the open position.

[0076] Figure 4B yes Figure 2A A top view of the cap, with the lock in the open position.

[0077] Figure 5A yes Figure 2A A bottom view of the hat, with the lock in the closed position.

[0078] Figure 5B yes Figure 2A A cross-sectional view of the cap, with the lock in the closed position.

[0079] Figure 6A It is a female connector and Figure 2A The cap is a cross-sectional view before the female connector is inserted into the cap.

[0080] Figure 6B yes Figure 2A A cross-sectional view of the cap, in which the female connector is inserted into the cap.

[0081] Figure 6C yes Figure 2A A cross-sectional view of the cap, in which the male connector is inserted into the cap.

[0082] Figure 7 This is a flowchart illustrating a method for attaching a universal cap to a male connector and a female connector. Detailed Implementation

[0083] The following description is provided to enable those skilled in the art to make and use the 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.

[0084] For the purposes described below, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in relation to the orientation of the invention in the accompanying drawings. The term “proximal” refers to the portion of a device or component that is grasped by a user or connected to another device or component. The term “distal” refers to the portion of a device or component opposite to the proximal portion (i.e., the portion furthest from being grasped by a user or connected to another component). For example, for implantable medical devices (such as catheters), the proximal portion may refer to the portion of the catheter that remains outside the patient's body and is manipulated by the user. The distal portion of the catheter may be the portion inserted into a blood vessel in the patient. For objects or components (such as elongated members), the proximal end may be the end connected to another object or component. The distal end of an elongated member is opposite to the proximal end and may be free not to be connected to other objects or components. However, it should be understood that the invention may present alternative variations and sequences of steps unless specifically stated otherwise. It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. Therefore, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0085] This disclosure relates to a cap 10 configured to connect to medical connectors 110, 112, such as access seats, ports, or valves for VADs, to prevent contamination of the connector, port, or VAD by, for example, microorganisms, debris, or other contaminants. In some examples, the cap 10 may be configured to clean or sterilize part of the connector 110, 112, or port, ensuring that the connector 110, 112, or port remains sterile prior to use. The cap 10 may be configured to remain in place on the connector 110, 112, or port for at least seven days, which is the maximum recommended usage time allowed by many medical facility aseptic practice guidelines.

[0086] Cap 10 is a universal cap, meaning it is configured to engage or connect to medical connectors 110, 112 of different sizes, constructions, and / or types. For example, cap 10 may be configured to engage or connect to both male connector 110 and female connector 112. As used herein, "male connector" refers to connector 110 that includes an elongated member (such as a tubular member or rod 114) configured to insert into a tube or opening having an inner diameter larger than the outermost diameter of male connector 110. Figure 1A An exemplary male connector 110 is shown. In contrast, a "female connector" refers to a connector 112 that includes an opening or port 116 configured to receive an elongated or tubular member of another object or device for connection to the female connector 112. The female connector 112 may include an elongated distal portion 108 having a cap or diaphragm 118 over the opening 116. Figure 1B An exemplary female connector 112 is shown, which includes a diaphragm 118 having a slit 120.

[0087] In some examples, cap 10 is configured to engage both male Luer connectors 110 and female Luer connectors 112. For example, cap 10 may be appropriately sized to receive female Luer connectors 112 with an outer diameter of about 7.0 mm to about 8.0 mm. Cap 10 may also be sized to receive male Luer connectors 110 with an outer diameter of about 8.0 mm to about 12.0 mm.

[0088] As used herein, a "Luer connector" refers to a connector that includes a tapered portion (i.e., a Luer taper) for establishing a frictional engagement between a tapered rod 114 or elongated member of a male Luer connector 110 and a tapered cavity. For example, a male Luer connector 110 may include a tapered rod 114 or elongated member having a tapered outer surface. A female Luer connector 112 may include a tapered cavity configured to receive and engage the tapered rod 114 or elongated member to connect the male Luer connector 110 to the female Luer connector 112.

[0089] In some examples, male connector 110 and female connector 112 may include engagement structures, such as threads, for pulling connectors 110, 112 to another connector or port. For example, as Figure 1A As shown, the male Luer connector 110 may include an annular shield 122 extending around a tapered rod 114 or an elongated member. The annular shield 122 may include threads 124 on its inner surface 126, configured to engage corresponding threads 128 on the outer surface 130 of the female Luer connector 112. Figure 1BAs shown, the female Luer connector 112 includes a thread 128 extending from its outer surface 130, which is positioned to engage a thread 124 on the inner surface 126 of the annular sheath 122 of the male Luer connector 110. Rotation of the female connector 112 relative to the male connector 110 causes the corresponding threads 124, 128 to engage, pulling the connectors 110, 112 together so that the tapered rod 114 or elongated member of the male Luer connector 110 moves through the opening 116 of the female connector 112. In some examples, the female connector 112 may also include a vertical rib 132 near the proximal end of the female connector 112, which can be used to manipulate the female connector 112 to make it easier to rotate the female connector 112 relative to another connector or device.

[0090] Many commercially available medical devices exist, such as seats, ports, and valves, which include various variations of male connector 110 or female connector 112, such as male Luer connectors and female Luer connectors. As described further in detail herein, the cap 10 of this disclosure includes a flexible sleeve that can be locked for engagement and secure connection to connectors 110, 112 of different types and sizes. For example, the cap 10 can be configured to attach to both male Luer connector 110 and female Luer connector 112, such as male or female Luer-Lok connectors from Becton Dickinson and Company. TM Connector. Cap 10 can also be configured to cover different connector designs, including but not limited to Becton Dickinson and Company's BD Q-Syte. TM BDMaxZero TM BD MaxPlus TM and SmartSite TM Pinless connector. Cap 10 can also be configured to connect to male and / or female connectors from other manufacturers, including but not limited to MicroClave® connectors (ICU Medical Inc.) and Ultrasite® connectors (B.Braun Medical Inc.). In other examples, cap 10 can be configured to connect to one or more of the following commercially available male connectors: Kendall 2001NP; BD MP5303-C; ICU Med 12664-28; RyMed RYM-5307HPU; B.Braun 470108; Baxter 2C8537; Kawasumi IV-0094; Zyno B2-70071-D; B.Braun470124; Baxter 2C7462; and Smith's Medical 536035.

[0091] Universal caps for male and female connectors

[0092] Figures 2A to 5B An example of a universal cap 10 is shown, which is configured to engage and / or connect to different types of connectors, such as either the previously described male connector 110 or female connector 112. Specifically, Figure 2A This is a perspective view of cap 10, showing that the lock of cap 10 is in the open position. Figure 2B This is a perspective view of cap 10, with the lock in the closed position. Figure 2C This is a cross-sectional view of cap 10, with the lock in the open position. Figure 3 This is an exploded view of cap 10. Figure 4A and 4B This is another view showing the cap 10 with the lock in the open position. Figure 5A and 5B This is another view showing cap 10 with the lock in the closed position. In some examples, cap 10 may be supplied as a single pre-packaged cap or cap assembly, for example... Figures 2A to 5B The packaging cap is shown. Furthermore, as described in further detail herein, the cap 10 includes components for cleaning, scrubbing, and disinfecting portions of the male connector 110 and female connector 112 inserted into and installed in the cap 10, such as sponges, abrasive surfaces, and / or cleaning or disinfecting solutions.

[0093] like Figures 2A to 5B As shown, the cap 10 includes a housing 12, which includes an open first end or top 14, a second end or bottom 16, and a sidewall 18 extending between the top 14 and the bottom 16. The housing 12 also includes an opening 20 extending through the sidewall 18 of the housing 12. For example, as... Figure 2A and 2B As shown, opening 20 can be a rectangular opening located between the top 14 and bottom 16 of housing 12. The rectangular opening 20 can have a long side extending circumferentially along housing 12 and a short side extending axially (e.g., between the top 14 and bottom 16 of housing 12). Figure 5B As shown, opening 20 can extend an angular distance of approximately 30 degrees to approximately 60 degrees (from...). Figure 5B (The angle α in the figure represents the angle). Other parts of the sidewall 18 of the housing 12 may not have openings.

[0094] The housing 12 may also include an extension or tab 22 extending from the sidewall 18 of the housing 12. The tab 22 may be configured to make it easier for a worker to grasp or manipulate the cap 10 when using it. For example, a worker may grasp the tab 22 before use when removing packaging, caps, and other seals from the cap 10. As further described herein, the tab 22 may include holes 24 and one or more slots 26 visible on the underside of the tab 22 (e.g., ...). Figure 2A , 2B (As shown in 4A and 5A), a lock 28 or locking mechanism is used to secure the cap 10 to the housing 12. For example, the lock 28 may be rotatably, slidably, and / or pivotally connected to the tab 22.

[0095] In some examples, the housing 12 also includes protrusions, such as axially extending ribs or spines 30, extending outward from the outer surface of the sidewall 18 of the housing 12. The axial spines 30 can be configured to increase the rigidity of the housing 12 compared to the absence of spines 30. Additionally, the spines 30 can make the housing 12 easier to grip and manipulate, thereby improving the usability of the cap 10 and, for example, making it less likely for an operator to drop or mishandle the cap 10 during use.

[0096] In some examples, the housing 12 is a molded part formed by injection molding or other common molding processes. The housing 12 can be formed from thermoplastic polymer materials such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene. In some examples, the housing 12 can be formed from a durable material, such as a material having a Shore hardness D value of less than or equal to 95 (Shore D). Alternatively, the housing 12 can be formed from a more flexible material, such as a material having a Shore hardness A value of less than or equal to 130 (Shore A).

[0097] The cap 10 also includes a flexible sleeve 32 disposed within the housing 12, the flexible sleeve being sized to receive connectors 110, 112 and configured to press or constrain against connectors 110, 112 to secure them within the housing 12. In some examples, the inner diameter of the flexible sleeve 32 may be larger than the maximum outer diameter of the distal portion of connectors 110, 112, such that the flexible sleeve 32 does not restrict the insertion of connectors 110, 112 into the housing 12 or otherwise contact with connectors 110, 112 until the flexible sleeve 32 is constrained against connectors 110, 112 by lock 28.

[0098] The flexible sleeve 32 may include a first end or top 34, a second end or bottom 36, and a sleeve sidewall 38 extending between the top 34 and the bottom 36. The flexible sleeve 32 may include or be formed of a flexible material capable of being radially pressed inward against the connectors 110, 112. For example, the flexible sleeve 32 may be made of silicone or other thermoplastic elastomers, such as polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene).

[0099] In some examples, the flexible sleeve 32 is a tubular body having a closed bottom 36 and an open top 34 configured to rest against a closed bottom 16 of the housing 12. The outer diameter of the sleeve sidewall 32 may match (e.g., may be equal to or slightly smaller, such as about 5% smaller) the inner diameter of the housing 12, such that the flexible sleeve 32 fits into the housing 12. The flexible sleeve 32 may define a cylindrical interior or cavity that receives the distal portions of connectors 110, 112. Furthermore, the sleeve sidewall 38 may be cylindrical, having a cylindrical inner surface and / or a cylindrical outer surface. The inner and / or outer surfaces of the sleeve sidewall 38 may be without threads or grooves. Instead, as previously described, connectors 110, 112 are secured in the housing 12 because the flexible sleeve 32 is restrained around connectors 110, 112 by a lock 28. More specifically, as described further in detail herein, connectors 110, 112 are secured to flexible sleeve 32 by radially inward pressure applied by lock 28 against flexible sleeve 32. Flexible sleeve 32 is not connected to connectors 110, 112 by engagement between the threads of connectors 110, 112 and the corresponding threads of flexible sleeve 32 or housing 12.

[0100] In some examples, the top 34 of the flexible sleeve 32 includes an annular flange 40 extending radially outward from an opening at the top 34 of the flexible sleeve 32. For example, as Figure 2C As shown, the annular flange 40 rests against the open top 14 of the housing 12, creating a space between the open top 14 of the housing 12 and a package (e.g., a protective cap 42) disposed on the open top 14 of the housing 12.

[0101] The cap 10 also includes a lock 28 connected to the housing 12, the lock being configured to move through an opening 20 in the sidewall 18 of the housing 12 to press against the sleeve sidewall 38. The lock 28 may engage (e.g., rotatably, slidably, and / or pivotally) or be connected to a tab 22 of the housing 12, such as... Figure 2A and 2B As shown most clearly, lock 28 can be configured to start from the open position (e.g., Figure 2A Move to the closed position (as shown) Figure 2B As shown), in the closed position, the lock 28 presses against the flexible sleeve 32. In some examples, the lock 28 applies a variable pressing force to the flexible sleeve 32, which increases proportionally with the rotation angle of the lock 28 relative to the tab 22 of the housing 12. Therefore, the further the lock 28 rotates in the first direction (as shown), the more pressure it applies to the flexible sleeve 32. Figure 4A and 4B As indicated by arrow A1 in the diagram, the tighter the connectors 110 and 112 are held within the housing 12.

[0102] In some examples, lock 28 is configured to be gripped and manipulated by a practitioner to move lock 28 from the open position. Figure 2A Move to the closed position. Figure 2B For example, an operator may grasp and press the lock 28, causing it to rotate, slide, and / or pivot toward the flexible sleeve 32. The pressure exerted by the lock 28 on the sleeve sidewall 38 of the flexible sleeve 32 causes the sleeve sidewall 38 to press directly or indirectly against a portion of the connector (e.g., male connector 110 or female connector 112) to secure the connectors 110, 112 within the housing 12. In some examples, the inner surface of the sleeve sidewall 38 directly contacts and presses against the connectors 110, 112 to secure them within the housing 12. In other examples, the sleeve sidewall 38 may indirectly contact the connectors 110, 112 through one or more intermediate structures. For example, the sleeve sidewall 38 may contact and press against an intermediate sleeve, layer, tube, component, or other structure to apply pressure from the lock 28 to the connectors 110, 112 through the sleeve sidewall 38.

[0103] For example, such as Figure 2B As shown, lock 28 applies pressure only to one side of flexible sleeve 32. Therefore, the pressure of lock 28 against flexible sleeve 32 can cause connectors 110 and 112 to be held in a non-concentric orientation within flexible sleeve 32. Specifically, female connector 112 can be held in a position within housing 12 where the longitudinal axis X2 of female connector 112 (in...) Figure 6A and 6B (As shown in the diagram) the longitudinal axis X1 of the housing 12 offset from the cap 10 (in...) Figure 2C , 6A (as shown in 6B).

[0104] In some examples, a portion of the lock 28 may be configured to be attached to the housing 12 to retain the lock 28 against the flexible sleeve 32 (i.e., to prevent the lock 28 from moving away from the flexible sleeve 32 until the lock 28 is released by the operator). For example, a first portion of the lock 28 (such as the proximal post 46) may be rotatably attached to the housing 12 such that the lock 28 is positioned about the first portion (e.g., about the proximal post 46) toward the flexible sleeve 32 in a first direction (by...). Figure 4A and 4B (As shown by arrow A1 in the diagram) rotate. Furthermore, a second part of the lock 28 (such as the distal post 48) can be connected to the housing 12 to prevent the lock 28 from rotating in a second direction (as indicated by arrow A1 in the diagram). Figure 5A and 5B (As indicated by arrow A2) Rotate away from the flexible sleeve 32.

[0105] In some examples, lock 28 is a molded part formed of the same or similar material as housing 12. For example, lock 28 may be formed of a thermoplastic polymer material such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene. Furthermore, lock 28 may include a proximal end 50 comprising a proximal post 46 connected to a tab 22 of housing 12. For example, the proximal post 46 of lock 28 may be inserted into a hole 24 in tab 22 such that lock 28 rotates about or away from flexible sleeve 32 about the proximal post 46. Lock 28 may also include a distal end 52 comprising a distal post 48 opposite to proximal end 50 and a cam portion 54 located between proximal end 50 and distal end 52 of lock 28. Cam portion 54 may include a concave inner surface 56 and a convex outer surface 58. Rotation of lock 28 relative to tab 22 (along...) Figure 4A and 4B (The first direction indicated by arrow A1 in the diagram) causes the convex outer surface 58 of the cam portion 54 to contact the flexible sleeve 32. Ideally, a majority of the area of ​​the convex outer surface 58 (e.g., at least 25%, 50%, or 75% of the total area of ​​the convex outer surface 58) contacts the flexible sleeve 32, thereby distributing the locking force from the lock 28 over a large portion of the outer surface of the sleeve sidewall 38. Therefore, the pressing force of the sleeve sidewall 32 against the connectors 110, 112 is distributed over a large portion of the outer surfaces of the connectors 110, 112. By distributing this pressing force over a large portion of the outer surfaces of the connectors 110, 112, a secure connection is formed between the connectors 110, 112 and the cap 10 without crushing or deforming any particular part or component of the connectors 110, 112.

[0106] The distal post 48 of the lock 28 can be configured to insert into the slot 26 of the tab 22 to hold the lock 28 in a pressed position against the flexible sleeve 32. Specifically, an operator can rotate the lock 28 toward the flexible sleeve 32, causing the cam portion 54 of the lock 28 to press against the flexible sleeve 32. Once sufficient pressure is applied against the flexible sleeve 32 to secure the connectors 110, 112 to the cap 10, the operator can push the lock 28 in an upward direction, which inserts the distal post 48 into the slot 26. By inserting the distal post 48 into the slot 26, the lock 28 is secured in place, preventing rotation away from the flexible sleeve 32, which secures the connectors 110, 112 within the housing 12. In some examples, the distal post 48 can slide through the slot 26 in a first direction to fasten the lock 28 against the flexible sleeve 32. In this configuration, slot 26 may include a protrusion that prevents the distal post 48 from moving through slot 26 in the second direction to release lock 28. To disengage lock 28, the operator removes the distal post 48 from slot 26, thereby releasing the lock from engagement with flexible sleeve 32.

[0107] In other examples, as shown, slot 26 includes protrusions forming segmental or circular holes or openings. Each segmental or circular opening can be sized to receive the distal post 48, thereby preventing the distal post 48 from sliding through slot 26 in any direction (i.e., preventing the distal post 48 from sliding through slot 26 in a first direction to secure lock 28 or in a second direction to release lock 28). In such an example, with the distal post 48 outside slot 26, the worker applies pressure to lock 28, causing it to press against flexible sleeve 32. Once lock 28 is sufficiently tight, the worker moves the distal post 48 into slot 26 to hold lock 28 in place against flexible sleeve 32. The worker releases lock 28 by removing the distal post 48 from slot 26.

[0108] In some examples, the distal end 52 of the lock 28 also includes a handle 60 configured to be gripped by a practitioner to rotate the lock 28 toward the flexible sleeve 32. For example, the handle 60 may include one or more flat pressing surfaces that a practitioner can manipulate to move the lock 28 from an open position to a closed position. The handle 60 may be designed to be large enough for a practitioner to easily grip and manipulate, for example, by pressing the handle 60 with one finger, two fingers, a thumb, and / or by gripping the handle 60 between fingers and a thumb.

[0109] The cap 10 also includes an absorber, absorbent member, or support structure (referred to herein as absorbent member 62) for cleaning and disinfecting the portions of the male connector 110 and female connector 112 that are inserted into the cap 10, such as the threaded surfaces of the connectors 110, 112 (e.g., the roots and crests of threads 124, 128). Specifically, absorbent member 62 may be configured to clean and disinfect the surface of the rod 114 and the inner surface 126 and threads 124 of the annular sheath 122 of the male connector 110. Absorbent member 62 may also be configured to clean and disinfect the distal portion 108, opening or port 116, and portion of the diaphragm 118 of the female connector 112.

[0110] like Figure 2C As shown, the absorbent member 62 can be arranged and held within a cylindrical internal space or cavity defined by the flexible sleeve 32. For example, the absorbent member 62 can be held in place within the flexible sleeve 32 by conventional adhesives or mechanical fasteners. In other examples, the absorbent member 62 can be held in place within the flexible sleeve 32 by friction between the inner surface of the sleeve sidewall 38 and the outer surface of the absorbent member 62.

[0111] In some examples, the absorbent member 62 comprises or is formed of an absorbent material capable of absorbing cleaning or disinfecting solutions for cleaning and / or disinfecting portions of the male connector 110 and female connector 112. Furthermore, the absorbent member 62 may be configured to axially compress as the distal portions of the connectors 110, 112 are inserted into the housing 12 and the flexible sleeve 32. This axial compression of the absorbent member 62 can cause the cleaning solution to flow away from the absorbent member 62 and contact the threads and other surfaces of the connectors 110, 112 to clean and disinfect portions of the connectors 110, 112.

[0112] In some examples, the absorbent member 62 may comprise a thermoplastic elastomer, such as polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene). The absorbent member 62 may also comprise a porous foam (e.g., open-cell foam) or sponge capable of absorbing cleaning or disinfecting solutions, such as a polyurethane-containing foam or sponge. In other examples, the foam material may be Plastrazote® foam, an engineered polymer foam manufactured by Zotefoams PCL.

[0113] In some examples, the height of the absorbent member 62 and / or the amount of cleaning or disinfecting solution contained therein can be optimized for use with both short connectors and high connectors 110, 112. As used herein, a “short connector” refers to connectors 110, 112 that are not inserted very far into cap 10. In contrast, a “high connector” refers to a connector that is inserted a considerable distance into cap 10, such that the distal ends of connectors 110, 112 are close to the bottom 36 of flexible sleeve 32. In particular, the height of the absorbent member 62 and the amount of cleaning or disinfecting solution contained therein should be large enough that sufficient cleaning solution is released from the absorbent member 62 to disinfect the surface of the short connector when cap 10 is attached to the short connector. However, the height of the absorbent member 62 and the amount of cleaning solution may be limited to a degree that prevents liquid from entering the lumen of connectors 110, 112 when cap 10 is attached to a higher connector (which would axially compress the absorbent member 62 by a considerable amount).

[0114] The absorbent component 62 may be provided (i.e., pre-impregnated) with a cleaning or disinfecting solution. For example, the cleaning or disinfecting solution may be an antimicrobial, antifungal, antibacterial, or antiviral solution that cleans and sterilizes the surfaces of connectors 110, 112. In some examples, the cleaning solution may be isopropanol (IPA), for example, about 70% IPA. In other examples, the cleaning solution may be a combination of about 0.5% to about 3.5% chlorhexidine gluconate with about 70% IPA. The chlorhexidine composition may be advantageous because it has a slower evaporation rate than IPA, thus providing more durable disinfecting activity after the cap 10 is removed from connectors 110, 112 and before the VAD is connected to the seat, port, or valve.

[0115] In some examples, the cap 10 also includes a seal 64 located on the absorbent member 62 (e.g., positioned between the top of the absorbent member 62 and the top 34 of the flexible sleeve 32). The seal 64 prevents fluid (e.g., a cleaning or disinfecting solution in the cap 10) from flowing into the lumen of the male Luer connector 110 when it is inserted into the cap 10. In some examples, the seal 64 may be made of a thermoplastic elastomer, including, for example, an elastomeric closed-cell foam. The seal 64 may also include an abrasive material capable of scrubbing or mechanically removing objects (e.g., microorganisms and debris) from the surfaces of the connectors 110, 112, while limiting the intrusion of cleaning or disinfecting solutions into portions of the connectors 110, 112.

[0116] In some examples, the cap 10 may also include a removable and / or disposable protective cover 42 located on the open top 14 of the housing 12 and / or the top 34 of the flexible sleeve 32. For example, as Figure 2C As shown, the protective cover 42 may extend over the top 34 and flange 40 of the flexible sleeve 32 and may adhere to a portion of the top 14 of the housing 12. A portion of the cover 42 may also extend over the top surface of the tab 22 of the housing 12 and / or may adhere to the top surface of the tab of the housing.

[0117] A protective cap 42 is provided to protect components and parts of the cap 10, such as the housing 12, flexible sleeve 32, seal 64, and absorbent member 62, during transport and storage to prevent contamination and evaporation of cleaning or disinfecting solutions before use. The protective cap 42 may comprise a sheet, such as a polymer film, with an adhesive on a first side for removably attaching the protective cap 42 to the open top of the housing 12. Alternatively, the protective cap 42 may be removably attached to the open top 14 of the housing 12 by heat sealing. The protective cap 42 may be made of an airtight or substantially airtight material so that the cleaning or disinfecting solution on the absorbent member 62 does not evaporate or dry out. Therefore, the protective cap 42 can increase the shelf life of the cap 10 and prevent microorganisms and other debris from accumulating in the cap 10 before use.

[0118] Method of attaching the connector to the cap

[0119] As previously stated, the cap 10 of this disclosure is a universal cap 10, which is configured to connect to male connectors 110 and female connectors 112 of various types and sizes. For example, Figure 6A and 6B The cap 10 is shown connected to the female connector 112. Figure 6C The cap 10 is shown connected to the male connector 110. Figure 7 This is a flowchart illustrating a method for connecting the universal cap 10 to the male connector 110 and the female connector 112 and / or disconnecting the universal cap from the male connector and the female connector.

[0120] like Figure 7 As shown, in step 210, in order to connect the cap 10 to the male connector 110 or the female connector 112, the practitioner first removes any packaging from the cap 10 and removes the protective cover 42 from the open top 14 of the housing 12.

[0121] At steps 212a and 212b, once the packaging and protective cover 42 are removed, the operator moves connectors 110 and 112 toward the open top 14 of the housing 12. For example, for the female connector 112 (shown at step 212a), the operator moves the female connector 112 toward the housing 12, as... Figure 6A As indicated by arrow A3, the diaphragm 118 of the female connector 112 contacts the seal 64 of the cap 10. Continuing to move the female connector 112 into the housing 112 allows the outer surface 130 and threads 128 of the tubular distal portion 108 of the female connector 112 to contact the seal 64. As previously described, the contact between the abraded surface of the seal 64 and the surface of the female connector 112 mechanically removes particles (e.g., microorganisms and other debris) from the surface of the female connector 112, contributing to the cleaning effect provided by the cap 10.

[0122] For male connector 110, as shown in step 212b, the practitioner positions male connector 110 in the direction of arrow A4 ( Figure 6C The male connector 110 is moved toward the open top 14 of the housing 12, causing the rod 114 of the male connector 110 to be partially inserted into the housing 12 and the distal end of the rod 114 to contact the seal 64. Continuing to move the male connector 110 into the housing 12 also causes the distal end of the annular shield 122 to contact the seal 64. As previously described, the contact between the surface of the male connector 110 and the seal 64 can mechanically remove particles (e.g., microorganisms and other debris) from the male connector 110.

[0123] Axial pressure continues to be applied to connectors 110 and 112, causing the distal portions of connectors 110 and 112 to be further inserted into the housing 12 and flexible sleeve 32, thereby axially compressing the absorbent member 62. The compression of the absorbent member 62 releases a cleaning or disinfecting solution, causing the solution to come into contact with portions of connectors 110 and 112. Specifically, the cleaning solution can contact and disinfect the surfaces of the shaft 114 and the annular sheath 122 of the male connector 110. When the female connector 112 is inserted into the cap 10, the cleaning solution can contact and disinfect portions of the female connector 112, including the diaphragm 118 and the outer surface 130 and threads 128 of the tubular distal portion 108 of the female connector 112.

[0124] Once the distal portions of connectors 110 and 112 have seated sufficiently within the flexible sleeve 32 of cap 10, the operator can use lock 28 to secure cap 10 to connectors 110 and 112. For example, as Figure 6C As shown, the male connector 110 can be inserted into the housing 12 such that the distal end of the annular cover 122 is positioned beyond the opening 20 in the sidewall 18 of the housing 12. Therefore, when the lock 28 is closed, the flexible sleeve 32 contacts the sidewall of the cover 122, as... Figure 6C As shown. Figure 6B As shown, the female connector 112 can be inserted into the housing 23 far enough that the tubular distal portion 108 of the female connector 112 is positioned through an opening 20 in the sidewall 18 of the housing 12. Therefore, when the lock 28 is closed, the flexible sleeve 32 is pressed against the widest portion of the female connector 112, as... Figure 6B As shown.

[0125] More specifically, in order to engage lock 28, at step 214, the worker first moves along the first direction (from... Figure 4A and 4B(As indicated by arrow A1 in the diagram) Press the lock 28 to move the convex outer surface 58 of the cam portion 54 through the opening 20 of the sidewall 18 toward the flexible sleeve 32. The convex outer surface 58 contacts the flexible sleeve 32, causing the sleeve 32 to deform radially inward, which results in the flexible sleeve 32 pressing against the connectors 110, 112. The practitioner continues to apply pressure to the lock 28 until the lock 28 is tight enough to secure the connectors 110, 112 in the cap 10.

[0126] At step 216, once the lock 28 is sufficiently tightened, the operator can slide the lock 28 upwards to insert the distal post 48 of the lock 28 into the slot 26 of the tab 22 of the housing 12. As previously described, by inserting the distal post 48 into the slot 26, the lock 28 is secured in the closed position, thereby preventing the lock 28 from loosening until the distal post 48 is removed from the slot 26.

[0127] At step 218, in order to remove the cap 10 from connectors 110, 112, the worker first removes the distal post 48 from the slot 26 and along the second direction (by Figure 5A and 5B (As indicated by arrow A2) Rotate away from the flexible sleeve 32 to release the lock 28.

[0128] At step 220, once lock 28 is released, the operator grasps the housing 12 of cap 10 with one hand and the connectors 110, 112 with the other. The operator then pulls connectors 110, 112 away from cap 10 to remove them. As previously stated, the inner surface of flexible sleeve 32 does not include threads. Therefore, the operator does not need to rotate or rotate connectors 110, 112 relative to cap 10 to remove them. Instead, once lock 28 is released, the operator only needs to pull connectors 110, 112 axially away from cap 10 to remove it. Once removed, cap 10 can be discarded, as it is typically a single-use product.

[0129] Once connectors 110 and 112 are completely removed from housing 12, they can be connected to the VAD at step 222. For example, connectors 110 and 112 can be attached to or inserted into the seat, port, or valve of the VAD to form a needle-free, impermeable fluid connection between connectors 110 and 112 and the flow path, channel, or lumen of the VAD.

[0130] Although examples of the general-purpose cap 10 and its usage methods are shown in the accompanying drawings and described in detail above, other examples will be apparent to those skilled in the art and readily made without departing from the scope and spirit of the invention. Therefore, the foregoing description is intended to be illustrative and not limiting. The invention described herein is defined by the appended claims, and all modifications to the invention falling within the meaning and equivalent scope of the claims are to be included within its scope.

Claims

1. A cap configured to engage at least a first connector and a second connector of different types, the cap comprising: A housing, the housing including an open first end, a second end, at least one sidewall extending between the first end and the second end, and at least one opening extending through the at least one sidewall; A flexible sleeve disposed in the housing includes a first end, a second end, and a sleeve sidewall extending between the first end and the second end of the flexible sleeve. A lock connected to the housing, the lock being configured to move through the at least one opening in the housing to press against the sleeve sidewall, which causes the sleeve sidewall to press directly or indirectly against a portion of the first connector or the second connector to secure the first connector or the second connector in the housing; and An absorbent member disposed in the flexible sleeve is configured to contain a cleaning solution for cleaning and / or disinfecting the portion of the first connector or the second connector that engages with the cap.

2. The cap of claim 1, wherein, The first connector is a female connector, and the second connector is a male connector.

3. The cap of claim 1, wherein, The inner surface of the flexible sleeve is a cylindrical surface without threads or grooves.

4. The cap of claim 1, wherein, The removable connection between the lock and the housing holds the lock against the flexible sleeve, thereby securing the first connector or the second connector within the housing.

5. The cap of claim 1, wherein, The flexible sleeve includes a thermoplastic elastomer, which includes at least one of silicone resin, polypropylene, polyethylene, or synthetic or natural rubber.

6. The cap of claim 1, wherein, The first end of the flexible sleeve includes an opening and a flange extending around the opening at the first end of the flexible sleeve, wherein the flange rests against the first end of the opening of the housing.

7. The cap of claim 1, wherein, The lock causes the flexible sleeve to deform radially inward to directly or indirectly contact the portion of the first connector or the second connector.

8. The cap of claim 1, wherein, The housing also includes a tab extending from at least one sidewall of the housing, and wherein the lock is rotatably engaged with the tab such that the lock rotates relative to the tab to press against the flexible sleeve.

9. The cap of claim 8, wherein, The tab of the housing also includes a slot, wherein a portion of the lock is inserted into the slot to hold the lock in contact with the flexible sleeve.

10. The cap according to claim 9, wherein, The lock includes a proximal end of the tab connected to the housing, a distal end opposite the proximal end, and a cam portion located between the proximal end and the distal end of the lock.

11. The cap according to claim 10, wherein, The cam portion includes a concave inner surface and a convex outer surface, wherein rotation of the lock relative to the housing causes the convex outer surface of the cam portion to contact the flexible sleeve.

12. The cap according to claim 10, wherein, The distal end of the lock includes a handle configured for a user to grip and rotate the lock toward the flexible sleeve.

13. The cap according to claim 10, wherein, The proximal end of the lock includes a proximal post configured to insert into a hole in the tab of the housing, thereby forming a rotation point for the lock to rotate relative to the housing, and the distal end of the lock includes a distal post configured to insert into a slot in the tab of the housing to hold the lock in a position against a flexible sleeve.

14. The cap according to claim 13, wherein, The slot includes a plurality of protrusions configured to engage the distal post to hold the lock in place relative to the flexible sleeve.

15. The cap according to claim 1, wherein, The locking force against the flexible sleeve causes the first connector or the second connector to be held in a position within the flexible sleeve, in which the longitudinal axis of the first connector or the second connector is offset from the longitudinal axis of the cap's housing.

16. The cap according to claim 1, wherein, The cap also includes a seal disposed on the absorbent member within the housing to clean and disinfect the first connector or the second connector when the first connector or the second connector is inserted into the housing.

17. The cap according to claim 1, wherein, The absorbent member includes an open-cell foam comprising a thermoplastic elastomer, and the cap further includes the cleaning solution absorbed by the absorbent support, wherein the cleaning solution comprises isopropanol.

18. The cap according to claim 1, wherein, The cap also includes a protective cap on the first end of the opening in the housing.

19. The cap according to claim 5, wherein, The natural rubber mentioned is isoprene.

20. A method for attaching a cap according to claim 1 to a first connector or a second connector, the method comprising: Insert the distal end of the first connector or the second connector through the first end of the opening of the housing and the first end of the flexible sleeve; An axial pressure is applied to the first connector or the second connector, causing the absorbent member to axially compress the distal end of the first connector or the second connector and move the distal end of the first connector or the second connector further into the flexible sleeve; and A portion of the lock is moved through at least one opening in at least one side wall of the housing, thereby pressing the flexible sleeve directly or indirectly against the first connector or the second connector to secure the first connector or the second connector in the housing.

21. A cap configured to engage at least a first connector and a second connector of different types, the cap comprising: A housing, the housing including an open first end, a second end, at least one sidewall extending between the first end and the second end, at least one opening extending through the at least one sidewall, and a tab extending outward from the at least one sidewall of the housing, the tab including a hole and a slot. A flexible sleeve disposed in the housing includes a first end, a second end, and a sleeve sidewall extending between the first end and the second end of the flexible sleeve. The lock includes: (i) a proximal post inserted into the hole of the tab, the proximal post providing rotational engagement between the lock and the tab; and (ii) a distal post configured to be inserted into the slot of the tab to prevent rotation of the lock relative to the tab; and An absorbent member disposed in the flexible sleeve is configured to contain a cleaning solution for cleaning and / or disinfecting the portion of the first connector or the second connector that engages with the cap.

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