Universal cap including interference projections for interference engagement with medical connectors

Abstract

A cap configured to engage with at least a first connector and a second connector of different types includes a housing having a first end, an open second end, a sidewall extending between the first end and the second end, and a plurality of interference protrusions extending inward from an inner surface of the sidewall configured to provide interference engagement with the first connector or the second connector, the cap also includes an absorbent support disposed within the housing configured to contact a portion of the first connector or the second connector when the first connector or the second connector is inserted into the housing, and a seal attached to a portion of the absorbent support configured to cover the opening of the first connector or the second connector when the first connector or the second connector is inserted into the housing.

Description

[Technical Field]

[0001] The present disclosure relates generally to caps for medical connectors, and more particularly to medical caps configured to be attached to at least two different types of connectors, such as male luer connectors or female luer connectors.

[0002] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Application No. 17 / 981,013, filed November 4, 2022, entitled "Universal Cap Including Interference Protrusions for Interference Engagement to Medical Connectors," the entire disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0003] Vascular access devices (VADs) are commonly used medical devices and 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, clogged with blood clots, or spread infection. Furthermore, when connecting a VAD to deliver fluids or medications to a patient, bacteria and other microorganisms can enter the patient's vascular system through the access hub, ports, or valves. Therefore, each access hub (or port / valve or connection) configured to attach to a VAD is associated with some risk of transmitting a catheter-related bloodstream infection (CRBSI) to the patient.

[0004] Many healthcare facilities implement aseptic techniques and protocols to ensure VADs and access hubs or ports are used properly and do not become blocked or infected. These protocols often include sterilizing the access hub, port, and VAD, as well as flushing the catheter with a flushing solution before use. Specifically, VAD standards of practice typically recommend performing flushing procedures after catheter placement, before infusion, medication administration, blood withdrawal, transfusion, and / or parenteral nutrition administration. Standards of practice may also require capping access hubs, ports, and valves with antiseptic caps when not in use to prevent microbial infiltration into the hub, port, or valve and to sterilize the area of ​​the hub, port, or valve that contacts the VAD. Antiseptic caps are disposable capping devices that contain a volume of cleaning or antiseptic solution to sterilize portions of the port, hub, and valve.

[0005] Access hubs and ports can include a variety of different types of male or female connectors for securing the hub or port to a VAD. Currently, healthcare professionals often carry several types of caps to cap different types of hubs and ports that may be used with a particular patient. For example, caps for male and female needleless connectors, as well as intravenous (IV) and hemodialysis lines, may use different connector designs and require different caps. In some examples, there may be a "male antiseptic cap device" for disinfecting ISO 594-2 type female threaded fluid luer connectors and a "female antiseptic cap device" for disinfecting ISO 594-2 type male threaded fluid luer connectors.

[0006] Several examples of universal caps that fit 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 Joints," which is incorporated herein by reference in its entirety, discloses a cap including threaded projections that can engage with both male and female connectors. However, there is a need for a simpler cap design that can be manufactured inexpensively and efficiently. The universal cap of the present disclosure is configured to attach to both male and female medical connectors in a manner sufficiently secure to prevent the entry of microorganisms. Furthermore, the universal cap of the present disclosure is configured to be easily manufactured in a single molding process. Summary of the Invention

[0007] According to one aspect of the present disclosure, a cap configured to engage with at least a first connector and a second connector of different types includes a housing having a first end, an open second end, a sidewall extending between the first end and the second end, and a plurality of interference projections extending inward from an inner surface of the sidewall configured to provide interference engagement with the first connector or the second connector. The cap also includes an absorbent support disposed within the housing configured to contact a portion of the first connector or the second connector when the first connector or the second connector is inserted into the housing, and a seal attached to a portion of the absorbent support configured to cover the opening of the first connector or the second connector when the first connector or the second connector is inserted into the housing.

[0008] According to another aspect of the present disclosure, a method for manufacturing a universal cap configured to engage at least a first connector and a second connector of different types includes molding a housing of the universal cap as a single molding process to produce a unitarily molded housing. The molded housing includes a first end covered by a first end wall, an open second end, a sidewall extending between the first end and the second end, and a plurality of interference protrusions extending inwardly from an inner surface of the sidewall configured to provide interference engagement with the first connector or the second connector. The method also includes inserting an absorbent support through the open second end of the housing such that the absorbent support abuts the first end wall of the housing, and inserting a seal against the end of the absorbent support.

[0009] According to one aspect of the present disclosure, a cap configured to engage with at least a first connector and a second connector of different types includes a housing having a first end, an open second end, a sidewall extending between the first end and the second end, and a plurality of interference projections extending inward from an inner surface of the sidewall configured to provide interference engagement with the first connector or the second connector. The cap also includes an absorbent support disposed within the housing and configured to contact a portion of the first connector or the second connector when the first connector or the second connector is inserted into the housing, and a seal attached to a portion of the absorbent support configured to cover the opening of the first connector or the second connector when the first connector or the second connector is inserted into the housing.

[0010] According to one embodiment of the present invention, the cap is configured to be secured to the second connector by an interference engagement between the interference protrusion and the second connector.

[0011] According to one embodiment of the present invention, when the first connector is inserted into the housing, the plurality of interference protrusions do not engage with the first connector.

[0012] According to an embodiment of the present invention, the housing further includes threads on the inner surface of the side wall, and the first connector is connected to the cap by engagement between the threads on the housing and corresponding protrusions or grooves on the first connector.

[0013] According to one embodiment of the present invention, the protrusion or groove of the first connector includes threads that engage with threads on the inner surface of the side wall of the housing.

[0014] According to one embodiment of the present invention, the first connector is a female luer connector.

[0015] According to one embodiment of the present invention, the housing is sized to receive a female luer connector having a maximum outer diameter of at least 9.0 mm.

[0016] According to one embodiment of the present invention, the threaded portion of the female luer connector has an outer diameter of less than 10.0 mm.

[0017] According to one embodiment of the present invention, the plurality of interference protrusions include a plurality of frangible ribs extending on the inner surface of the side wall of the housing, the ribs being configured to be frangible by the outer surface of the second connector, thereby forming an interference engagement between the second connector and the cap.

[0018] According to one embodiment of the present invention, the plurality of frangible ribs extend substantially parallel to the longitudinal axis of the housing.

[0019] According to one embodiment of the present invention, a plurality of frangible ribs are spaced circumferentially around the interior surface of the housing.

[0020] According to one embodiment of the present invention, a plurality of frangible ribs are equally spaced around the circumference of the inner surface of the housing.

[0021] According to one embodiment of the present invention, the plurality of frangible ribs include rounded surfaces that curve about the longitudinal axis of the ribs.

[0022] According to one embodiment of the present invention, the plurality of interference protrusions includes (i) a first group of a plurality of interference protrusions on a first stage of the housing having a first inner diameter, and (ii) a second group of a plurality of interference protrusions on a second stage of the housing having a second inner diameter different from the first inner diameter.

[0023] According to one embodiment of the present invention, a first group of the plurality of interference protrusions is spaced apart around a first step of the housing, and a second group of the plurality of interference protrusions is spaced apart around a second step of the housing.

[0024] According to one embodiment of the present invention, the plurality of protrusions include frangible ribs extending substantially parallel to the longitudinal axis of the housing, and a first group of the plurality of interfering protrusions is not axially aligned with a second group of the plurality of interfering protrusions.

[0025] According to one embodiment of the present invention, the second connector includes a male luer connector having a stem configured to be inserted into the absorbent support, the male luer connector opening being sealed by a seal attached to the absorbent support, and the plurality of interference protrusions forming an interference engagement with a portion of the male luer connector.

[0026] According to one embodiment of the present invention, the male luer connector further includes an annular shield having a threaded inner surface extending around the stem.

[0027] According to one embodiment of the present invention, the housing is sized to receive a male luer connector having an outer diameter of 8.0 mm to 14.0 mm.

[0028] According to one embodiment of the present invention, a side wall of the housing having a flexible portion proximate the second end of the housing is configured to compress and deform to accommodate a portion of the first connector or the second connector when the first connector or the second connector is inserted into the housing.

[0029] According to one embodiment of the present invention, the flexible portion of the sidewall has a variable inner diameter that is widest at the second end of the housing and narrows towards the first end of the housing.

[0030] According to one embodiment of the present invention, the flexible portion includes multiple steps having different inner diameters.

[0031] According to one embodiment of the present invention, the flexible portion of the side wall is configured to extend radially outward to accommodate a portion of the first connector or the second connector that has an outer diameter that is larger than the inner diameter of the side wall in an unbiased state.

[0032] According to one embodiment of the present invention, the side wall further includes a rigid portion that does not deform when the first connector or the second connector is inserted into the housing.

[0033] According to one embodiment of the present invention, the rigid portion includes a threaded inner surface configured to engage a corresponding threaded outer surface of the first connector and a plurality of outward protrusions extending outward from the outer surface of the side wall to increase the rigidity of the rigid portion.

[0034] According to one embodiment of the present invention, the rigid portion includes an area of ​​increased wall thickness and / or an area that is co-molded with a polymer that is stiffer than the material forming other areas of the housing.

[0035] According to one embodiment of the present invention, the housing is a single molded part.

[0036] According to one embodiment of the present invention, the housing comprises a rigid thermoplastic polymer such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.

[0037] According to one embodiment of the present invention, the absorbent support includes a cylindrical member sized to be received within a substantially cylindrical cavity defined by a portion of the inner surface of the sidewall of the housing.

[0038] According to one embodiment of the present invention, the absorbent support comprises a porous foam having a thermoplastic elastomeric material.

[0039] According to one embodiment of the present invention, when the first connector or the second connector is inserted into the cap, the connector contacts the absorbent support, and the contact between the connector and the absorbent support mechanically removes matter from the outer surface of the connector.

[0040] According to one embodiment of the present invention, the cap further comprises a cleaning or disinfecting solution absorbed by the absorbent support, and the seal is configured to prevent or restrict the cleaning or disinfecting solution from flowing from the absorbent support into the lumen of the first connector or second connector engaged to the cap.

[0041] According to one embodiment of the present invention, the cleaning or disinfecting solution comprises an antibacterial, antifungal, antibacterial, or antiviral composition.

[0042] According to one embodiment of the present invention, the cleaning or disinfecting solution comprises about 0.5% to about 3.5% chlorhexidine gluconate, about 60% to 85% isopropyl alcohol (IPA), or a combination thereof.

[0043] According to one embodiment of the present invention, the seal comprises a closed cell foam.

[0044] According to one embodiment of the present invention, a removable protective cover is attached to the open second end of the housing to protect the interior of the housing and the absorbent support prior to use.

[0045] According to one embodiment of the present invention, the protective cover includes a film having an adhesive on a first side of the film for removably attaching the first side of the film to the open second end of the housing.

[0046] According to one embodiment of the present invention, the protective cover is substantially airtight to prevent the absorbent support from drying out prior to use.

[0047] According to one embodiment of the present invention, the protective cover is connected to the open second end of the housing by heat sealing.

[0048] According to one embodiment of the present invention, the absorbent support is configured to clean and / or disinfect the distal portion and outer surface of the female connector, the tip and outer surface of the stem, and the inner surface of the annular shield of the male connector.

[0049] According to one embodiment of the present invention, the absorbent support includes a cavity extending axially inward from the second end face of the absorbent support, and the seal is received within the cavity.

[0050] According to an embodiment of the invention, the housing includes a first step having a first inner diameter, a second step adjacent the first flexible step having a second inner diameter larger than the first inner diameter, and a third step between the second step and the open second end of the housing having a third inner diameter larger than either the first or second inner diameter.

[0051] According to one embodiment of the present invention, the plurality of interference protrusions are disposed on the first stage and / or the second stage of the housing, and the third stage does not include any interference protrusions.

[0052] According to one embodiment of the present invention, the housing further includes a threaded rigid portion between the first step and the first end of the housing.

[0053] According to one embodiment of the present invention, the threaded rigid portion includes threads extending inwardly from the inner surface of the side wall configured to engage corresponding threads on the first connector.

[0054] According to one embodiment of the present invention, the threaded rigid portion further includes an outward protrusion extending outward from the outer surface of the side wall to increase the rigidity of the side wall.

[0055] According to one embodiment of the present invention, the first end of the housing is closed by including a wall that extends over the side wall of the housing.

[0056] According to one embodiment of the present invention, a method of manufacturing a universal cap configured to engage with at least a first connector and a second connector of different types includes molding the housing of the universal cap as a single molding process to produce an integrally molded housing, the housing having a first end covered by a first end wall, an open second end, a side wall extending between the first end and the second end, and a plurality of interference protrusions extending inward from the inner surface of the side wall configured to provide interference engagement with the first connector or the second connector; inserting an absorbent support through the open second end of the housing such that the absorbent support abuts the first end wall of the housing; and inserting a seal against the end of the absorbent support.

[0057] According to one embodiment of the present invention, the universal cap is configured to be secured to the second connector by interference engagement between the interference protrusions and the second connector, and when the first connector is inserted into the housing, the plurality of interference protrusions do not engage with the first connector.

[0058] According to one embodiment of the present invention, the plurality of interference protrusions include a plurality of frangible ribs extending on the inner surface of the side wall of the housing, the frangible ribs being configured to be frangible by the outer surface of the second connector, thereby forming an interference engagement between the second connector and the cap.

[0059] According to one embodiment of the present invention, the housing is formed by injection molding.

[0060] According to one embodiment of the present invention, molding the housing includes injecting a flowable polymer precursor into a mold and curing the polymer precursor to form a rigid thermoplastic polymer such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.

[0061] According to one embodiment of the present invention, the absorbent support comprises a cylindrical member sized to be received within a substantially cylindrical cavity defined by a portion of the inner surface of the sidewall of the housing.

[0062] According to one embodiment of the present invention, the method further comprises soaking the absorbent substrate in a cleaning or disinfecting solution, such as an antibacterial, antifungal, antibacterial, or antiviral composition.

[0063] According to one embodiment of the present invention, the cleaning or disinfecting solution comprises about 0.5% to about 3.5% chlorhexidine gluconate, about 60% to 85% isopropyl alcohol (IPA), or a combination thereof.

[0064] According to one embodiment of the present invention, the method further includes attaching a removable protective cover over the open second end of the housing.

[0065] According to one embodiment of the present invention, the protective cover includes a film having an adhesive on a first side of the film for removably attaching the first side of the film to the open second end of the housing.

[0066] According to one embodiment of the present invention, the protective cover is attached to the housing by heat sealing. [Brief explanation of the drawings]

[0067] [Figure 1A] FIG. 1A is a cross-sectional view of an exemplary male connector known from the prior art. [Figure 1B]FIG. 1B is an example of a female connector including a septum with a slit, as known in the prior art. [Figure 2A] FIG. 2A is a perspective view of a universal cap for medical connectors according to one embodiment of the present disclosure. [Figure 2B] FIG. 2B is a front view of the universal cap of FIG. 2A. [Figure 2C] FIG. 2C is another perspective view of the universal cap of FIG. 2A, showing the open end of the cap. [Figure 2D] FIG. 2D is an exploded perspective view of the universal cap of FIG. 2A. [Figure 2E] FIG. 2E is a cross-sectional view of the universal cap of FIG. 2A. [Figure 3A] FIG. 3A is a perspective view of a housing of the cap of FIG. 2A according to one embodiment of the present disclosure. [Figure 3B] FIG. 3B is a cross-sectional view of the housing of FIG. 3A. [Figure 3C] FIG. 3C is a bottom view of the housing of FIG. 3A. [Figure 4A] 4A is a perspective cross-sectional view showing a male luer connector inserted into the universal cap of FIG. 2A according to one embodiment of the present disclosure. [Figure 4B] 4B is a perspective cross-sectional view showing a male luer connector inserted into the universal cap of FIG. 2A according to one embodiment of the present disclosure. [Figure 4C] FIG. 4C is a front cross-sectional view of the universal cap connected to the male luer connector of FIGS. 4A and 4B. [Figure 4D] 4D is a front cross-sectional view of another exemplary male luer connector inserted into the universal cap of FIG. 2A according to one embodiment of the present disclosure. [Figure 5A] 5A is a front cross-sectional view of a female luer connector inserted into the universal cap of FIG. 2A according to one embodiment of the present disclosure. [Figure 5B]5B is a front cross-sectional view of another exemplary female luer connector inserted into the universal cap of FIG. 2A according to one embodiment of the present disclosure. [Figure 6] FIG. 6 is a flowchart illustrating a method for manufacturing a universal cap according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0068] [Detailed Description of the Invention] The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0069] Hereinafter, for purposes of description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives shall refer to the present invention as illustrated in the drawings. However, it should be understood that the present invention may employ various alternative variations and step sequences unless expressly specified to the contrary. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0070] The present disclosure relates to a cap 10 configured to connect to a medical connector 110, 112, such as an access hub, port, or valve for a VAD, to prevent the connector, port, or VAD from becoming contaminated with, for example, microorganisms, debris, or other contaminants. In some examples, the cap 10 can be configured to clean or disinfect the connector 110, 112 or port to ensure that the connector 110, 112 or port remains sterile prior to use. The cap 10 can be configured to remain on the connector 110, 112 or port for at least seven days, which is the maximum recommended time of use permitted by aseptic practice guidelines in many medical facilities. The cap 10 can be configured to engage or connect with medical connectors 110, 112 of different sizes, configurations, or types. For example, the cap 10 can be configured to engage or connect with both male and female connectors 110, 112.

[0071] (Male and female luer connectors) As used herein, "male connector" refers to a connector 110 that includes an elongated member, such as a tubular member or stem 114, configured to be inserted into a tube or opening having an inner diameter larger than the maximum outer diameter of the male connector 110. An exemplary male connector 110 is shown in FIG. 1A. "female connector" refers to a connector 112 that includes an opening or port 116 configured to receive an elongated member or tubular member of another object or device to connect the other object or device to the female connector 112. The female connector 112 can include a cover or septum 118 over the opening 116. An exemplary female connector 112 that includes a septum 118 with a slit 120 is shown in FIG. 1B.

[0072] In some examples, the cap 10 of the present disclosure is configured to engage with both a male luer connector 110 and a female luer connector 112. For example, the cap 10 can be configured to accept a female luer connector 112 having an outer diameter of at least 9.0 mm, at least 10.0 mm, or at least 12.5 mm. The cap 10 can also be sized to accept a male luer connector 110 having an outer diameter of from about 8.0 mm to about 14.0 mm.

[0073] As used herein, "luer connector" refers to a connector that includes a tapered portion (i.e., luer taper) for creating frictional engagement between the tapered stem 114 or elongated member of the male luer connector 110 and the tapered cavity. Specifically, the male luer connector 110 can include a tapered stem 114 or elongated member having a tapered outer surface. The female luer connector 112 can include a tapered cavity configured to receive and engage the tapered stem 114 or elongated member to connect the male luer connector 110 to the female luer connector 112.

[0074] To secure the male and female connectors 110, 112 together, in some examples, the connectors 110, 112 can include engaging structure, such as threads, to draw the connectors 110, 112 toward one another. For example, as shown in FIG. 1A , the male luer connector 110 can include an annular shield 122 extending around the tapered stem 114 or elongated member. The annular shield 122 can include threads 124 on an inner surface 126 of the shield 122 configured to engage with corresponding threads 128 on an outer surface 130 of the female luer connector 112. As shown in FIG. 1B , the female luer connector 112 can include threads 128 extending from its outer surface 130 that are positioned to engage with the threads 124 on the inner surface 126 of the annular shield 122 of the male luer connector 110. Twisting the female connector 112 relative to the male connector 110 engages the corresponding threads 124, 128, drawing the connectors 110, 112 toward one another, with the tapered stem 114 or elongated member of the male luer connector 110 moving through the opening 116 of the female connector 112. In some examples, the female connector 112 can also include a vertical ridge 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 twist the female connector 112 compared to another connector or device. As previously mentioned, the cap 10 of the present disclosure is configured to cover both the male luer connector 110 (shown in FIG. 1A ) and the female luer connector 112 (shown in FIG. 1B ).

[0075] (Universal cap for male and female connectors) 2A-2E show an exemplary universal cap 10 configured to connect to different types of connectors, such as both a male luer connector 110 and a female luer connector 112. Specifically, FIG. 2A is a perspective view of the cap 10. FIG. 2B is a front view of the cap 10. FIG. 2C is a perspective view of the open lower end (bottom end) 20 of the cap 10. FIG. 2D is an exploded perspective view of the cap 10. FIG. 2E is a cross-sectional view of the cap 10.

[0076] 2A-2E, cap 10 comprises a housing 12 including a first or upper end 18, an open second or lower end 20, and a sidewall 22 extending between upper end 18 and lower end 20. Upper end 18 of cap 10 can be open or can comprise a top wall 24 extending above upper end 18 of housing 12.

[0077] The cap 10 further includes an absorbent support 14 disposed in the housing 12 and configured to contact a portion of the male connector 110 or female connector 112 inserted into the housing 12. For example, the cap 10 can be configured such that, when attached to the male luer connector 110, the stem 114 or elongated member of the male luer connector 110 is inserted into the absorbent support 14 to form an interference engagement with the absorbent support 14. A lower portion (bottom) of the housing 12 can also engage with a corresponding portion of the male luer connector 110 to form an additional interference engagement between the housing 12 and the connector 110. For example, the housing 12 can include one or more interference protrusions 50 extending inward from an inner surface 52 of the side wall 22 of the housing 12. The interference protrusions 50 can be configured to provide or enhance the interference engagement between the cap 10 and a portion of the connector 110, 112.

[0078] The cap 10 further comprises a seal 16 attached to a portion of the absorbent support 14 configured to cover an opening or lumen of the male connector 110 or female connector 112 when the male connector 110 or female connector 112 is inserted into the housing 12. For example, when the male luer connector 110 is inserted into the housing 12, the seal 16 can contact and cover an opening at the distal end of the stem 114 or elongate member of the male luer connector, sealing the male luer connector 110. The seal 16 can prevent fluids, such as cleaning or disinfecting solutions, within the cap 10 from entering the lumen of the male connector 110.

[0079] The cap 10 is configured to engage with a variety of different configurations and orientations of medical connectors 110, 112. For example, the cap 10 can be configured to be secured to the female connector 112 by either an interference or threaded engagement between the inner surface 52 of the housing 12 and a portion of the female connector 112. The cap 10 can also be configured to be secured to the male connector 110 by an interference or frictional engagement between the outer surface 130 of the male connector 110 and the interference projections 50 and / or absorbent support 14.

[0080] There are many different commercially available medical devices, such as hubs, ports, and valves, which may include different variations of male or female connectors 110, 112. The cap 10 of the present disclosure is configured to conform or change shape so that it can be secured to many different types and sizes of connectors. For example, the cap 10 of the present disclosure can be configured to attach to Becton Dickinson and Company's male or female Luer-Lok® connectors. The cap 10 of the present disclosure can also be configured to cover different connector designs, including, but not limited to, Becton Dickinson and Company's BD Q-Syte®, BD MaxZero®, BD MaxPlus®, and SmartSite® needle-free connectors. The 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, the cap 10 can be configured to connect to one or more of the following commercially available male connectors: Kemdall 2001NP, BD MP5303-C, ICU Med 12664-28, RyMed RYM-5307HPU, B.Braun 470108, Baxter 2C8537, Kawasumi IV-0094, Zyno B2-70071-D, B.Braun 470124, Baxter 2C7462, and Smith's Medica 1536035.

[0081] In some examples, the housing 12 of the cap 10 can be a molded part formed from a thermoplastic material such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene. The material can be a durable material, such as a material having a Shore D hardness value of 60 Shore D or less. Alternatively, the cap 10 can be formed from a more flexible material, such as a material having a Shore A hardness value of 80 Shore A or less. The housing 12 can be formed as a single, integral and / or molded part. For example, the housing 12 can be formed by an injection molding process in which the entire housing 12 is formed in a single mold.

[0082] 2A-2E and 3A-3C , in some examples, the sidewall 22 of the housing 12 includes a flexible portion 26 proximate the lower end 20 of the housing 12 that is configured to compress and deform to accommodate a portion of the female connector 112 or the male connector 110 when the connectors 110, 112 are inserted into the housing 12. The flexible portion 26 of the sidewall 22 can be configured to extend radially outward to accommodate a portion of the connectors 110, 112 that has an outer diameter that is larger than the inner diameter of the sidewall 22 of the housing 12 in an unbiased state. As used herein, "unbiased state" refers to the orientation of the cap 10 when no external force is applied to the cap 10 and when the cap 10 is not connected to a connector device or port. The flexible portion 26 can also be configured to bend, compress, or deform to conform to the curvature of the distal end portion of the connector 110, 112, hub, or port, such that the bottom end 20 of the cap 10 curves when inserted into the connector 110, 112, hub, or port. Additionally, the flexible portion 26 of the side wall 22 can be configured to deform to form a frictional or interference fit with the male connector 110 to secure the cap 10 to the male connector 110.

[0083] As previously mentioned, the housing 12 can be made in a single molding process, meaning that the flexible portion 26 of the housing 12 can be formed from the same material as other, more rigid regions of the housing 12. In that case, the flexible portion 26 of the housing 12 can be molded to be thinner than other regions of the housing 12, thereby providing sufficient flexibility for the flexible portion 26 to deform and conform to the shape of and / or engage with the connector 110, 112, hub, or port.

[0084] In some examples, the flexible portion 26 of the sidewall 22 has a variable inner diameter to accommodate different sized connectors 110, 112. For example, the flexible portion 26 can be widest at the lower end 20 of the housing 12 and narrow as one moves axially through the housing 12. In some examples, portions or the entire flexible portion 26 can be tapered, with an interior cavity having an angled or frustoconical surface. In other examples, the flexible portion 26 can be stepped, such that the inner diameter of the flexible portion 26 decreases, but intermittently, as one moves axially through the housing 12. For example, the flexible portion 26 of the sidewall 22 can include three steps, each with a different inner diameter, as shown in FIGS. 2A-3C. Each step includes a substantially vertical wall and an annular horizontal tread 56.

[0085] More specifically, the stepped flexible portion 26 can include a narrowest or first step 44 having a first inner diameter D1 disposed at the top of the flexible portion 26. The stepped flexible portion 26 further includes an intermediate or second step 46 having a second inner diameter D2 and a third step 48 having a third inner diameter D3. Although not shown in FIGS. 2A-3C , one or more of the steps 44, 46, 48 can have an annular tapered or angled surface. In some examples, the first, second, and third steps 44, 46, 48 can be sized or configured to mate with the annular shield 122 (shown in FIG. 1A ) or other portions of different commercially available male connectors 110 or female connectors 112. For example, the different steps of the flexible portion 26 can have inner diameters D1, D2 that match the outer diameter of the annular shield 122 of the commercially available male connector 110. Many commercially available male connectors 110 have annular shields 122 with outer diameters of either 9.1 mm to 9.4 mm or 10.3 mm to 10.4 mm. For example, male connectors 110 from RyMed, B. Braun, Zyno, and Smith's Medical often have outer diameters of approximately 9.1 mm to 9.4 mm. In contrast, male connectors 110 from Kendall, Becton Dickinson, ICU Medicals, Baxter, and Kawasumi often have outer diameters of approximately 10.4 mm.

[0086] Thus, the narrowest or first step 44 can be adapted to form an interference fit with an annular shield 122 having an outer diameter of about 9.1 mm to about 9.4 mm, meaning that the inner diameter D1 of the first step 44 can be about 9.1 mm or slightly larger. The second step 46 can be adapted to form an interference fit with an annular shield 122 having an outer diameter of about 10.3 mm or 10.4 mm, meaning that the inner diameter D2 of the second step 46 can be about 10.3 mm or slightly larger. The third step 48 can be adapted to form an interference fit with a portion of a female connector, such as a portion of Becton Dickinson's BD Q-Syte® connector. In particular, the diameter D3 of the third step 48 can be about 13.4 mm or about 13.5 mm to form an interference fit with the vertical ridge 132 of the female connector 112 shown in FIG. 1B.

[0087] As previously mentioned, the flexible portion 26 of the housing 12 further includes an interference protrusion 50 extending radially inward from the inner surface 52 of the sidewall 22. The interference protrusion 50 can be configured to contact and form an interference fit with the annular shield 122 of the male connector 110. The interference protrusion 50 can be positioned so as not to form an interference fit with the female connector 112 when the female connector 112 is inserted into the cap 10. Instead, the female connector 112 can form an interference or threaded fit with other portions of the housing 12. The interference protrusion 50 can have a variety of shapes and configurations, depending, for example, on how securely the cap 10 is to be engaged with the connectors 110, 112. For example, the interference protrusion 50 can include a straight or curved rib or ridge, a detent, a notch, an annular flange, or other structure that protrudes inward from the inner surface 52 of the sidewall 22.

[0088] In some examples, the interference protrusions 50 are frangible ribs extending on the inner surface 52 of the sidewall 22 of the housing 12. As used herein, "frangible" refers to a structure configured to be deformed (e.g., bent, pushed downward, folded, wrinkled, broken, flattened, or otherwise altered in shape) when the connector 110 is pressed against the interference protrusions 50 or ribs, thereby creating an interference engagement between the male connector 110 and the cap 10. For example, as shown in FIGS. 2C, 2E, and 3A-3C, the frangible ribs can be elongated structures that extend axially through the housing 12 along portions of the inner surface 52 of the sidewall 22. For example, the ribs can be parallel or substantially parallel (e.g., within about 15 degrees, 10 degrees, or 5 degrees of parallel) to the longitudinal axis of the housing 12. In some examples, the housing 12 includes multiple groups of protrusions 50 or ribs. For example, the housing 12 may include a first group of ribs extending inwardly from the inner surface 52 of the first step 44 of the housing 12 and a second group of ribs extending inwardly from the inner surface 52 of the second step 46 of the housing 12. The first group of ribs may be configured to form an interference fit with a male connector 110 having a narrow shield 122 (e.g., a shield 122 having an outer diameter of about 9.1 mm to about 9.4 mm). The second group of ribs (in the second step 46) may be configured to form an interference fit with a male connector 110 having a wider shield 122 (e.g., a shield 122 having an outer diameter of about 10.4 mm). The third step 48, which may be sized to engage with the vertical ridge 132 (shown in FIG. 1B ) of the female connector 112, may be free of interference protrusions 50 or frangible ribs.

[0089] The interference projections 50 or ribs can be any suitable length, determined, for example, based on the dimensions of the steps 44, 46, 48 and / or based on how tightly the male connector 110 should fit into the cap 10. In some examples, the ribs have a length D4 (shown in FIG. 2E) of about 2.25 mm to about 2.50 mm. To provide sufficient interference engagement with the connector 110, the ribs can protrude from the inner surface 52 of the side wall 22 a distance or height of about 0.1 mm to about 0.5 mm, or preferably about 0.3 mm, and can have a width of about 2.30 mm to about 2.50 mm. Additionally, in some examples, the ribs can have rounded or chamfered surfaces that curve about the longitudinal axis of each rib.

[0090] The interference projections 50 or ribs can be spaced apart along the circumference of the stages 44, 46. The ribs can be equally spaced apart from one another, or the angular distance between the ribs can vary. As shown in FIG. 3C, the housing 12 can include six ribs in each stage 44, 46 of the housing 12 (i.e., 12 ribs total). In other examples, the stages 44, 46 can include fewer than six ribs or more than six ribs. The six ribs in each stage 44, 46 can be spaced apart by approximately 60 degrees. Furthermore, as shown in FIG. 2E, the ribs in different stages 44, 46 do not need to be axially aligned but can be offset by an angular distance of, for example, approximately 15 degrees. Specifically, as shown in FIGS. 2 and 3C, the ribs in the first stage 44 can be positioned at 0, 60, 120, 180, 240, and 300 degrees along the circumference of the first stage 44. The ribs of the second stage 46 may be positioned at 15 degrees, 75 degrees, 135 degrees, 195 degrees, 255 degrees, and 315 degrees around the circumference of the second stage 46 .

[0091] In some examples, the sidewall 22 of the cap 10 also includes a rigid portion 30 that does not deform when the male connector 110 or the female connector 112 is inserted into the housing 12. The rigid portion 30 can be a substantially cylindrical structure extending between the closed top end 18 of the housing 12 and the first step 44 of the flexible portion 26 of the sidewall 22. The rigid portion 30 can be formed from the same material as the flexible portion 26. However, the rigid portion 30 can be thicker than the flexible portion 26 to resist deformation. In some examples, the rigid portion 30 includes an inner surface 32 having threads 34 configured to engage with threads 128 on the outer surface 130 of the female connector 112. For example, the threads 34 can make one or more full turns around the inner surface 32 of the rigid portion 30, depending on the height of the rigid portion 30. 2A-3E, the threads 34 can rotate at least two full revolutions around the inner surface 32 of the rigid portion 30 to ensure that the cap 10 can be used with female connectors 112 of various heights. In other examples, the inner surface 32 of the rigid portion 30 can be smooth without threads. In that case, the cap 10 can be configured to form an interference fit between the inner surface 32 of the rigid portion 30 and the female connector 112.

[0092] In some examples, the rigid portion 30 further includes outward protrusions, such as axial ridges 36, extending outward from the outer surface 38 of the sidewall 22 to provide rigidity to the rigid portion 30. The axial ridges 36 may also make the cap 10 easier for a user to grip and manipulate. The axial ridges 36 can have a wide variety of shapes. For example, the ridges 36 can be square or rectangular and have longitudinal edges extending along the length of each ridge 36. In other examples, the surfaces of the ridges 36 can be rounded, chamfered, or curved. As shown in FIG. 2A , the rigid portion 30 can include six axial ridges 36 located at 0 degrees, 60 degrees, 120 degrees, 180 degrees, 240 degrees, and 300 degrees along the circumference of the rigid portion 30 of the cap 10. In other examples, the rigid portion 30 can include fewer than six axial ridges 36 or more than six axial ridges 36. Alternatively or additionally, the rigid portion 30 may include regions that are co-molded with a stiffer polymer to increase the stiffness of the rigid portion 30 .

[0093] 2D and 2E, the absorbent support 14 of the cap 10 can be a cylindrical structure or member sized to be received within a substantially cylindrical cavity defined by the inner surface 32 of the rigid portion 30. The absorbent support 14 can be held within the cylindrical cavity by conventional adhesives or fasteners. In other examples, the absorbent support 14 can be held in place by friction between the inner surface 32 of the rigid portion 30 and the absorbent support 14.

[0094] In some examples, the absorbent support 14 can be formed from an absorbent material capable of absorbing cleaning or disinfecting solutions for cleaning and / or disinfecting portions of the male connector 110 and the female connector 112. In particular, the absorbent support 14 can be formed and configured to clean and / or disinfect the distal or upper portion of the female connector, including the septum 118 and slit 120 shown in FIG. 1B and the outer surface 130 of the tubular portion of the female connector 112. The absorbent support 14 can also be formed and configured to clean and / or disinfect the tip and sides of the stem 114 of the male connector 110 (shown in FIG. 1A), as well as the inner surface 126 and threads 124 of the annular shield 122.

[0095] In some examples, the material of the absorbent support 14 can be abrasive, having sufficient texture, friction, and / or anti-slip properties to scrub the surfaces of the connectors 110, 112 and mechanically remove microorganisms, debris, and other contaminants from the surfaces of the connectors 110, 112. The absorbent support 14 can also have sufficient texture to create or reinforce an interference engagement with the stem 114 or elongated member of the male connector 110 when the male connector 110 is inserted into the housing 12. The absorbent support 14 can include a thermoplastic elastomer such as polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene).

[0096] In some examples, the absorbent support 14 can be a porous foam or sponge capable of absorbing cleaning or disinfecting solutions. For example, the foam material can be Plastazpte® foam, an engineering polymer foam of Zotefoams PCL. Desirably, the porosity of the absorbent support 14 should be optimized so that the material is abrasive enough to scrape or mechanically remove objects from the surfaces of the connectors 110, 112, while simultaneously limiting the penetration of cleaning or disinfecting solutions into portions of the connectors 110, 112. Furthermore, the height of the absorbent support 14 and / or the amount of cleaning or disinfecting solution contained therein can be optimized for use with connectors 110, 112 of different lengths (e.g., both tall and short connectors). As used herein, a "short connector" refers to a connector that is not inserted very deeply into the cap 10. A "tall connector" refers to a connector that is inserted a significant distance into the cap 10, such that the distal end of the connector is proximate the top wall 24 of the housing 12. For example, short connectors 110, 112 are shown in Figures 4A-4C and 5B. Tall connectors 110, 112 are shown in Figures 4D and 5A. Generally, the height of the absorbent support 14 and the amount of cleaning fluid contained therein should be large enough so that sufficient cleaning fluid is released from the absorbent support 14 when the cap 10 is attached to the short connectors 110, 112 to disinfect the surfaces of the short connectors 110, 112. However, the height of the absorbent support 14 and the amount of cleaning fluid may be somewhat limited when the cap 10 is attached to taller connectors 110, 112 to prevent intrusion of fluid into the lumens of the connectors 110, 112.

[0097] The absorbent support 14 can be provided with (i.e., pre-soaked in) a cleaning or disinfecting solution. For example, the cleaning or disinfecting solution can be an antibacterial, antifungal, antibacterial, or antiviral solution that cleans and sterilizes the surfaces of the connectors 110, 112. In some examples, the cleaning solution can be isopropyl alcohol (IPA), such as about 70% IPA. In other examples, the cleaning solution can be about 0.5% to about 3.5% chlorhexidine gluconate, alone or in combination with about 70% IPA. Chlorhexidine compositions can be beneficial because they evaporate more slowly than IPA, thereby providing a more sustained disinfecting effect after the cap 10 is removed from the connectors 110, 112 and before the VAD is connected to a hub, port, or valve.

[0098] In some examples, the absorbent support 14 includes a cavity 40 extending axially inward from an end face of the absorbent support 14. For example, the cavity 40 can be a cylindrical cavity. The cavity 40 can be sized to accommodate the seal 16 such that the seal 16 is properly positioned to contact and seal against the ends of the connectors 110, 112 when the connectors 110, 112 are inserted into the housing 12. The seal 16 can be formed from a material that prevents fluids, such as cleaning fluids, from entering the connectors 110, 112. For example, the seal 16 can include a non-porous, closed-cell foam that is denser and / or stiffer than the foam used in the absorbent support 14.

[0099] As shown in FIG. 2D , the cap 10 can also include a removable protective cover 42 attached to the open lower end 20 of the housing 12 to protect the interior of the housing 12 and the absorbent support 14 contained therein prior to use. The protective cover 42 can include a sheet, such as a polymeric film, having an adhesive on a first side of the sheet for removably attaching the protective cover 42 to the open lower end 20 of the housing 12. Alternatively, the protective cover 42 can be removably attached to the lower end 20 of the cap 10 by heat sealing. The protective cover 42 can be slightly larger than the lower end 20 of the housing 12 so that it can be easily grasped by a practitioner to remove the protective cover 42 from the cap 10 prior to use. The protective cover 42 can be formed from a material that is impermeable or substantially impermeable to air so that the cleaning solution on the absorbent support 14 does not evaporate or dry out prior to use of the cap 10. The protective cover 42 therefore extends the shelf life of the cap 10 and prevents microorganisms and other debris from collecting within the cap 10 prior to use.

[0100] The cap 10 can be provided in a variety of packages or containers as known in the art.

[0101] For example, the caps 10 can be individually packaged in a paper or plastic package. In other examples, multiple caps 10 can be provided together in a single package. For example, multiple caps 10 can be provided on a strip of paper or plastic film configured to hang from, for example, an IV pole. Multiple caps 10 can also be packaged in blisters or flow wrap on a strip or card to protect the caps if they are dropped prior to use.

[0102] (How to use the universal cap) As previously discussed, the cap 10 of the present disclosure is configured to connect to a variety of different types of male connectors 110 and female connectors 112. FIGS. 4A-4D show the cap 10 attached to different examples of male connectors 110. FIGS. 5A and 5B show the cap 10 attached to different examples of female connectors 112. Specifically, in FIGS. 4A-4C, the cap 10 is connected to a short male connector 110, such as a BD Q-Syte® connector from Becton Dickinson and Company. FIG. 4D shows the cap 10 attached to a taller male connector 110, such as a BD MaxPlus® connector from Becton Dickinson and Company. FIG. 5A shows the cap 10 attached to a taller female connector 112 (e.g., a BD MaxPlus® connector). FIG. 5B shows the cap 10 attached to a short female connector 112 (e.g., a BD Q-Syte®). Exemplary male and female connectors 110, 112, including features of the BD Q-Syte® connector, are described in U.S. Pat. No. 7,806,890, entitled "Volume-Changing Vascular Access Device," which is incorporated herein by reference in its entirety.

[0103] To connect the cap 10 to the male connector 110, the practitioner first removes the packaging and protective cover 42 from the cap 10. The practitioner then pushes the cap 10 into the male connector 110 in the direction of arrow A1 (shown in FIGS. 4A-4D ). The stem 114 of the male connector 110 contacts and seals with the seal 16 enclosed within the housing 12 of the cap 10. Contact between the male connector 110 and the seal 16 or absorbent support 14 creates an interference fit that secures the cap 10 to the male connector 110. Additionally, contact between the outer surface of the male connector 110 and an interference protrusion 50, such as a frangible rib extending inwardly from the inner surface 52 of the side wall 22 of the housing 12, creates an additional interference or frictional fit between the male connector 110 and the cap 10 to secure the cap 10 to the male connector 110. As previously mentioned, contact between the male connector 110 and the absorbent support 14 can also release a cleaning fluid, allowing the cleaning fluid to contact and sterilize the surfaces of the male connector 110. In particular, the cleaning fluid can contact both the outer surface of the stem 114 of the male connector 110 and the inner surface 126 of the annular shield 122 of the male connector 110, thereby disinfecting and sterilizing both surfaces 114, 126. Finally, direct contact between the surface of the male connector 110 and the abrasive portion of the absorbent support 14 or seal 16 can mechanically remove microorganisms, debris, and other contaminants from the surface of the male connector 110, contributing to the disinfecting effect provided by the cap 10. To remove the cap 10 from the male connector 110, a practitioner grasps the cap 10 and pulls it away from the male connector 110 with sufficient force to overcome interference and / or frictional engagement between the male connector 110 and portions of the cap 10. Once the cap 10 is removed, the VAD can be connected to a hub, port, or valve via the male connector 110 as previously described.

[0104] FIG. 5A shows the cap 10 attached to or inserted into the tall female connector 112. To connect the cap 10 to the tall female connector 112, a practitioner first removes the packaging from the cap 10 and removes the protective cover 42 from the bottom end 20 of the housing 12. The female connector 112 is inserted into the cap 10 (as indicated by arrow A1 in FIG. 5A ), bringing the threads 128 of the female connector 112 into contact with the threads 34 on the inner surface 32 of the side wall 22 of the housing 12. As previously mentioned, the flexible portion 26 of the side wall 22 can deform to conform to the size and shape of the female connector 112. Once the threads 128 of the female connector 112 contact the threads 34 of the housing 12, the practitioner rotates the cap 10 around the female connector 112, as indicated by arrow A2 in FIG. 5A , to secure the cap 10 to the connector 112. Rotating the cap 10 may compress the absorbent substrate 14 and / or release the irrigation fluid, which may contact and sterilize the surface of the female connector 112. In particular, the irrigation fluid may contact and sterilize the septum 118 of the female connector 112 and a portion of the outer surface 130 of the female connector 112. To remove the cap 10, the practitioner rotates the cap 10 in the opposite direction, disengaging the threads 34 of the housing side wall 22 from the threads 128 of the female connector 112. Once the threads 34, 128 are disengaged, the practitioner can pull the cap 10 away from the female connector 112.

[0105] FIG. 5B shows the cap 10 attached to or inserted into a short female connector 112, such as a female BD Q-Syte®. To connect the cap 10 to the short female connector 112, the practitioner pushes the cap 10 into the short female connector 112 in the direction of arrow A1 (shown in FIG. 5B). The opening 116 and / or septum 118 of the female connector 112 contact and are sealed with the seal 16 enclosed within the housing 12 of the cap 10. The contact between the female connector 112 and the seal 16 or absorbent support 14 creates an interference fit that secures the cap 10 to the female connector 112. However, the threads 128 of the female connector 112 do not engage the threads 34 in the rigid portion 30 of the housing 12. Instead, a vertical ridge 132 near the base of the female connector 112 can contact the inner surface 52 of the sidewall 22, creating additional interference or frictional engagement between the female connector 112 and the cap 10 to secure the cap 10 to the female connector 112. As previously mentioned, contact between the female connector 112 and the absorbent support 14 also expels irrigation fluid, allowing the irrigation fluid to contact and sterilize the surface of the female connector 110. To remove the cap 10 from the short female connector 112, the practitioner grasps the cap 10 and pulls it away from the female connector 112 with enough force to overcome the interference and / or frictional engagement between the female connector 112 and a portion of the cap 10.

[0106] (Universal Cap Manufacturing Method) The universal cap 10 of the present disclosure is desirably a disposable product that can be inexpensively and efficiently manufactured through a simple molding process requiring only a few assembly steps. An exemplary simple method for manufacturing the universal cap 10 is shown in the flow chart of FIG.

[0107] As shown in FIG. 6 , a method for manufacturing a universal cap 10 configured to engage with at least a first connector (e.g., a female luer connector 112) and a second connector (e.g., a male luer connector 110) of different types comprises, in step 210, molding the housing 12 of the universal cap 10 as a single molding process to produce the integrally molded housing 12. The housing 12 can be, for example, the previously described housing 12 shown in FIGS. 2A-3C . For example, the housing 12 can include a first end or upper end 18 that can be covered by a first end or top wall 24, an open second end or lower end 20, and a sidewall 22 extending between the upper end 18 and the lower end 20. The housing 12 can further include an interference protrusion 50 extending inward from an inner surface 52 of the sidewall 22. As previously described, the interference protrusion 50 can be configured to provide interference engagement with the male connector 110. In some examples, the interference protrusion 50 can be a frangible rib extending on the inner surface 52 of the side wall 22. The frangible rib can be configured to be frangible by the outer surface of the male connector 110, thereby forming an interference engagement between the male connector 110 and the cap 10.

[0108] In some examples, the housing 12 of the cap 10 is formed by injection molding, in which a polymer precursor material is injected into a single mold in a single molding process. Desirably, the single molding process forms all parts of the housing 12, including the interference projections 50, and does not require additional processing or machining of the housing 12. More specifically, in some examples, molding the housing 12 includes depositing a flowable polymer precursor into a mold in an injection molding machine. The method further includes curing the polymer precursor to form a rigid thermoplastic polymer, such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.

[0109] In step 212, the method further includes inserting the absorbent support 14 through the open lower end 20 of the housing 12 after molding of the housing 12 is complete, such that the absorbent support 14 abuts the top end wall 24 of the housing 12. As previously mentioned, the absorbent support 14 can be a cylindrical member sized to be received within a substantially cylindrical cavity defined by a portion of the inner surface 52 of the side wall 22 and the lower surface (bottom) of the top end wall 24 of the housing 12.

[0110] At step 214, the method further includes inserting a seal 16 against the lower end (bottom end) of the absorbent support 14. The seal 16 can be a disk-shaped member comprising closed-cell foam. As previously described, when the male connector 110 or female connector 112 is inserted into the cap 10, the seal 16 is configured to cover the opening of the connector 110, 112 and prevent cleaning solutions or other fluids from flowing through the opening into the lumen of the connector 110, 112.

[0111] At step 216, the method further includes immersing the absorbent support 14 in a cleaning or disinfecting solution, such as an antibacterial, antifungal, antibacterial, or antiviral composition. In some examples, the cleaning or disinfecting solution can include about 0.5% to about 3.5% chlorhexidine gluconate, about 60% to 85% isopropyl alcohol (IPA), or a combination thereof. The absorbent support 14 can be immersed in the cleaning or disinfecting solution before inserting the absorbent support 14 into the cap 10. In other examples, the cleaning or disinfecting solution can be added after the absorbent support 14 and / or seal 16 are placed within the cap 10. For example, the cleaning or disinfecting solution can be poured into the cap 10 through the open bottom end 20 so that it can be absorbed by the absorbent support 14.

[0112] At step 218, the method may further include attaching a removable protective cover 42 over the open lower end 20 of the housing 12 after the cleaning or disinfecting solution has been absorbed by the absorbent support 14, thereby forming a sealed universal cap 10. In some examples, the protective cover 42 comprises a film having an adhesive on its upper side for removably attaching or affixing the film to the open lower end 20 of the housing 12. Alternatively, the protective cover 42 or film may be attached to the open lower end 20 of the housing 12 by heat sealing. Once the protective cover 42 is in place, the cap 10 is essentially ready for use. Thus, the completed caps 10 may be individually packaged in paper or plastic packaging, or multiple caps 10 may be packaged together in a single package. For example, multiple caps 10 may be provided on a strip of paper or plastic film configured to hang from, for example, an IV pole. Multiple caps 10 may also be packaged in blisters or flow wrap on a strip or card to protect the caps if they are dropped prior to use.

[0113] Although examples of the universal cap and method of use of the present disclosure are shown in the accompanying drawings and described in detail above, other examples will be apparent to and readily made by those skilled in the art without departing from the scope and spirit of the present invention. Accordingly, the foregoing description is intended to be illustrative rather than limiting. The present invention as described above is defined by the appended claims, and all changes to the invention that come within the meaning and range of equivalency of the claims are embraced within their scope.

Claims

1. A cap configured to engage with at least two different types of first and second connectors, A housing comprising a first end, an open second end, a side wall extending between the first end and the second end, and a plurality of interference protrusions extending inward from the inner surface of the side wall, configured to provide interference engagement with the first connector or the second connector, An absorbent support disposed within the housing is configured to contact a portion of the first connector or the second connector when the first connector or the second connector is inserted into the housing, A cap comprising: a seal attached to a portion of the absorbent support configured to cover the opening of the first connector or the second connector when the first connector or the second connector is inserted into the housing.

2. The cap according to claim 1, wherein the cap is configured to be fixed to the second connector by the interference engagement between the interference projection and the second connector.

3. The cap according to claim 2, wherein when the first connector is inserted into the housing, the plurality of interference protrusions do not engage with the first connector.

4. The cap according to claim 2, wherein the housing further includes threads on the inner surface of the side wall, and the first connector is connected to the cap by engagement between the threads of the housing and a corresponding projection or groove on the first connector.

5. The cap according to claim 1, wherein the plurality of interference protrusions include a plurality of shatterable ribs extending on the inner surface of the side wall of the housing, the ribs being configured to be shattered by the outer surface of the second connector, thereby forming the interference engagement between the second connector and the cap.

6. The cap according to claim 5, wherein the plurality of crushable ribs extend substantially parallel to the longitudinal axis of the housing.

7. The cap according to claim 5, wherein the plurality of crushable ribs are arranged at equal intervals along the circumference of the inner surface of the housing.

8. The cap according to claim 5, wherein the plurality of crushable ribs have rounded surfaces that curve about the longitudinal axis of the ribs.

9. The cap according to claim 1, wherein the plurality of interference protrusions comprises (i) a first group of the plurality of interference protrusions in a first step of the housing having a first inner diameter, and (ii) a second group of the plurality of interference protrusions in a second step of the housing having a second inner diameter different from the first inner diameter.

10. The cap according to claim 9, wherein the first group of the plurality of interference protrusions is spaced apart around the first step of the housing, and the second group of the plurality of interference protrusions is spaced apart around the second step of the housing.

11. The cap according to claim 10, wherein the plurality of interference protrusions comprises a crushable rib extending substantially parallel to the longitudinal axis of the housing, and the first group of the plurality of interference protrusions is not axially aligned with the second group of the plurality of interference protrusions.

12. The side wall of the housing is provided with a flexible portion adjacent to the second end of the housing, configured to press and deform to accommodate a portion of the first connector or the second connector when the first connector or the second connector is inserted into the housing. The flexible portion of the side wall has a variable inner diameter that is widest at the second end of the housing and narrows towards the first end of the housing. The cap according to claim 1, wherein the flexible portion comprises a plurality of steps having different inner diameters.

13. The cap according to claim 1, wherein the housing is an integrally molded part comprising a rigid thermoplastic polymer including polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.

14. The cap according to claim 1, wherein the absorbent support includes a cylindrical member sized to be received in a substantially cylindrical cavity defined by a portion of the inner surface of the side wall of the housing.

15. The system further comprises a cleaning solution or disinfectant solution absorbed by the absorbent support, The cleaning solution or disinfectant solution comprises approximately 0.5% to approximately 3.5% chlorhexidine gluconate, approximately 60% to 85% isopropyl alcohol (IPA), or a combination thereof. The cap according to claim 1, wherein the seal is configured to prevent or restrict the flow of the cleaning solution or disinfectant solution from the absorbent support into the lumen of the first connector or the second connector engaged with the cap.

16. The cap according to claim 1, further comprising a removable protective cover attached to the open second end of the housing for protecting the inside of the housing and the absorbent support before use.

17. The aforementioned housing is A first step having a first inner diameter, A second step adjacent to the first step, having a second inner diameter larger than the first inner diameter, The cap according to claim 1, further comprising a third step between the second step and the open second end of the housing, the third step having a third inner diameter larger than the first inner diameter or the second inner diameter.

18. The cap according to claim 17, wherein the plurality of interference protrusions are arranged on the first and / or second stage of the housing, and the third stage does not include any interference protrusions.

19. The cap according to claim 18, wherein the housing further comprises a threaded rigid portion between the first step and the first end of the housing, the threaded rigid portion comprising threads extending inward from the inner surface of the side wall of the housing, configured to engage with corresponding threads of the first connector.

20. A method for manufacturing a universal cap configured to engage with at least different types of first and second connectors, A single molding process for producing an integrally formed housing is to mold the housing of the universal cap, wherein the housing comprises a first end covered by a first end wall, an open second end, a side wall extending between the first end and the second end, and a plurality of interference protrusions extending inward from the inner surface of the side wall, configured to provide interference engagement with the first or second connector. Insert the absorbent support through the open second end of the housing so that the absorbent support abuts against the first end wall of the housing, Inserting a seal into the end of the absorbent support, A method for providing this.

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