Disinfection cap for male and female connectors including a deformable housing - Patent Application 20070122997

Abstract

The cap, configured to engage with different types of first and second connectors, includes a housing having a first end, an open second end, a sidewall extending therebetween, and a radially extending flange extending outward from the sidewall or the open second end. The cap also includes an absorbent member disposed within the housing configured to contain a cleaning solution for cleaning and / or disinfecting a portion of the first or second connector engaged with the cap. The housing is configured to move between a first position, in which the housing is configured to engage with the first connector, and a second position, in which the housing is configured to engage with the second connector, by folding the sidewall of the housing so that the flange surrounds a portion of the sidewall between the first and second ends of the housing.

Description

[Technical Field]

[0001] The present disclosure relates generally to caps for medical connectors, and more particularly to medical caps configured to attach to either male or female connectors to seal, clean, and disinfect portions of the connector. [Background technology]

[0002] This application claims priority to U.S. Application No. 18 / 100,285, filed January 23, 2023, entitled "Disinfecting Cap for Male and Female Connectors Including Deformable Housing," the disclosure of which is incorporated herein by reference in its entirety.

[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 an unsterile 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, port, valve, or other 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 have 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 IV and hemodialysis lines, often use different connector designs and may require different caps. There can 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," incorporated herein by reference in its entirety, discloses a cap including thread 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 disclosed herein is configured to attach to both male and female medical connectors in a manner secure enough to prevent the entry of microorganisms. Furthermore, the cap disclosed herein is configured to connect or engage with the connector through friction and / or interference engagement that is independent of the connector's threads. Therefore, the universal cap disclosed herein can be used with connectors having a variety of thread patterns, configurations, and dimensions. Furthermore, the universal cap disclosed herein is configured for easy manufacturing in a single molding process. Summary of the Invention [Means for solving the problem]

[0007] According to one aspect of the present disclosure, a cap configured to engage at least a first connector and a second connector of different types includes a housing having a first end, an open second end, at least one sidewall extending between the first end and the second end, and a radially extending flange extending outward from the sidewall or the open second end. The cap also includes an absorbent member disposed within the housing configured to contain a cleaning solution for cleaning and / or disinfecting a portion of the first connector or the second connector engaged with the cap. The housing is configured to move between a first position, in which the housing is configured to engage with the first connector, and a second position, in which the housing is configured to engage with the second connector, by folding the sidewall of the housing so that the flange surrounds a portion of the sidewall between the first end and the second end of the housing.

[0008] According to another aspect of the present disclosure, a method for installing the aforementioned cap includes folding a sidewall of the cap such that the housing moves from a first position to a second position, and inserting a second connector into the folded overcap such that a stem of the second connector is received in a slit extending axially through the absorbent member.

[0009] According to another aspect of the present disclosure, a method for attaching the aforementioned cap to a first connector includes inserting an end of the first connector into the cap with the housing in a first position such that the tubular body and / or other threads of the female connector contact the absorbent member.

[0010] According to one embodiment of the present invention, a cap is configured to engage with at least a first connector and a second connector of different types, the cap comprising: a housing having a first end, an open second end, at least one sidewall extending between the first end and the second end, and a radially extending flange extending outward from the sidewall or the open second end; and an absorbent member disposed within the housing configured to contain a cleaning solution for cleaning and / or disinfecting a portion of the first connector or the second connector that engages with the cap; and the housing is configured to move between a first position in which the housing is configured to engage with the first connector and a second position in which the housing is configured to engage with the second connector by folding over the sidewall of the housing.

[0011] According to an embodiment of the present invention, the first connector is a female needleless connector and the second connector is a male needleless connector.

[0012] According to one embodiment of the present invention, a female needleless connector includes a female luer connector having a tubular body defining a tapered cavity sized to receive the stem of a male luer connector, a septum over an opening in the tubular body, and external threads extending radially outward from an outer surface of the tubular body.

[0013] According to one embodiment of the present invention, the cap is engaged to the female connector by interference or frictional engagement between the inner surface of the sidewall and the outer surface of the tubular body and / or the external threads of the female connector.

[0014] According to an embodiment of the present invention, a male needleless connector includes a male Luer connector comprising a stem including a proximal end, a distal end, and a tapered outer surface extending therebetween, the stem defining a fluid channel extending through the stem, an annular shield around the stem connected to the proximal end of the stem, and threads extending inward from the inner surface of the annular shield.

[0015] According to an embodiment of the present invention, the cap is engaged to the male connector by interference or frictional engagement between a portion of the folded side wall and the inner surface of the annular shield of the male luer connector.

[0016] According to an embodiment of the present invention, the cap is sized to accept male and / or female connectors having different thread configurations and dimensions.

[0017] According to one embodiment of the present invention, the cap is sized to accept a female connector having an outer diameter of about 8.0 mm to about 10.0 mm and a screw having a thread width of about 0.3 mm to about 1.0 mm and a thread root width of about 0.5 mm to 1.2 mm.

[0018] According to one embodiment of the present invention, the absorbent member is configured to clean and / or disinfect the threaded surface of the first connector or the second connector.

[0019] According to an embodiment of the present invention, the first end of the housing includes a domed outer surface and a substantially flat inner surface.

[0020] According to an embodiment of the present invention, in the second position, the outer surface of the lower portion of the side wall faces the outer surface of the upper portion of the side wall.

[0021] According to an embodiment of the invention, the side walls include a notch or groove in the side walls between the top and bottom to facilitate folding of the side walls to move the housing from the first position to the second position.

[0022] According to one embodiment of the present invention, the housing further includes at least one annular ridge extending radially inward from the inner surface of the distal portion of the sidewall.

[0023] According to one embodiment of the present invention, the housing further includes a plurality of annular ridges extending radially inward from the inner surface of the lower portion of the sidewall.

[0024] According to one embodiment of the present invention, the annular ridge includes an O-ring extending from the inner surface of the sidewall.

[0025] According to one embodiment of the present invention, the wall thickness of the lower portion of the side wall is less than the wall thickness of the upper portion of the side wall.

[0026] According to one embodiment of the present invention, the outer diameter of the absorbent member substantially matches the inner diameter of the upper portion of the housing.

[0027] According to one embodiment of the present invention, the housing comprises a thermoplastic polymer including at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.

[0028] According to one embodiment of the present invention, the absorbent member comprises a thermoplastic elastomer including at least one of silicone, polypropylene, polyethylene, or synthetic or natural rubber (eg, isoprene).

[0029] According to one embodiment of the present invention, the absorbent member comprises a sponge.

[0030] According to one embodiment of the present invention, the absorbent member comprises an open cell foam, such as a porous foam comprising a thermoplastic elastomer.

[0031] According to an embodiment of the present invention, when the first connector or the second connector is inserted into the housing, the absorbing member is compressed in the axial direction.

[0032] According to one embodiment of the present invention, axial compression of the absorbent member causes cleaning liquid in the absorbent member to contact the threads and surfaces of the first connector or the second connector.

[0033] According to one embodiment of the present invention, the absorbent member includes a cylindrical body having an outer diameter that substantially corresponds to the smallest inner diameter of the housing, and a slit extending axially through the cylindrical body.

[0034] According to one embodiment of the present invention, the slit extends axially through the body to the distal end of the cylindrical body.

[0035] According to one embodiment of the present invention, the portions of the tubular body separated by the slit are configured to separate to receive the stem of a male luer connector.

[0036] According to one embodiment of the present invention, when the housing is in the first position, the absorbent member is enclosed within the housing and accessible through the second open end of the housing, and when the cap is in the second position, a lower portion of the absorbent member protrudes beyond the folded side wall of the housing.

[0037] According to one embodiment of the present invention, the cap further comprises a cleaning fluid that is absorbed by the absorbent member.

[0038] According to one embodiment of the present invention, the cleaning liquid comprises isopropyl alcohol (IPA).

[0039] According to one embodiment of the present invention, the cleaning solution comprises about 0.5% to about 3.5% chlorhexidine gluconate and about 70% IPA.

[0040] According to an embodiment of the invention, the housing is moved from the first position to the second position by applying a downward force to the first end of the housing and / or an upward force to the distal surface of the flange.

[0041] According to one embodiment of the present invention, the cap further includes a protective cover covering the open second end of the housing.

[0042] According to one embodiment of the present invention, the protective cover is attached to the housing by heat sealing.

[0043] According to one embodiment of the present invention, a method for attaching a cap to a second connector includes folding a side wall of the cap such that the housing moves from a first position to a second position, and inserting the second connector into the folded cap such that a stem of the second connector is received within a slit extending axially through the absorbent member.

[0044] According to an embodiment of the present invention, the second connector has a male luer connector including a stem having a proximal end, a distal end, and a tapered outer surface extending therebetween, the stem defining a fluid channel extending through the stem, an annular shield around the stem connected to the proximal end of the stem, and threads extending inward from the inner surface of the annular shield.

[0045] According to one embodiment of the present invention, when engaging the cap, the stem of the male luer connector is inserted into the slit in the absorbent member and the surface of the folded housing contacts the threads of the annular shield forming a frictional or interference fit between the cap and the annular shield.

[0046] According to one embodiment of the present invention, the inner diameter defined by the threads of the annular shield is smaller than the maximum outer diameter of the housing when the housing is in the second position.

[0047] According to an embodiment of the present invention, the method also includes removing a protective cover from the housing that is positioned over the open second end of the housing before inserting the second connector into the housing.

[0048] According to one embodiment of the present invention, a method for attaching a cap to a first connector includes inserting an end of the first connector into the cap with the housing in a first position such that the tubular body and / or other threads of the female connector contact the absorbent member.

[0049] According to an embodiment of the present invention, the outer diameter of the tubular body of the first connector is greater than the maximum inner diameter of the housing. [Brief explanation of the drawings]

[0050] [Figure 1A] FIG. 1A is a cross-sectional view of a typical male connector known in the prior art. [Figure 1B] FIG. 1B is an example of a closed 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 in an initial position for use with a female connector according to one embodiment of the present disclosure. [Figure 2B] FIG. 2B is a cross-sectional view of the cap of FIG. 2A in an initial position. [Figure 2C] FIG. 2C is a cross-sectional view of the housing of the cap of FIG. 2A according to an embodiment of the present disclosure. [Figure 3A] 3A is a cross-sectional view of the cap and female needleless connector of FIG. 2A in an initial position according to an embodiment of the present disclosure. [Figure 3B] 3B is a cross-sectional view of the cap of FIG. 2A connected to the female needleless connector of FIG. 3A according to one embodiment of the present disclosure. [Figure 4] FIG. 4 is a schematic diagram illustrating a medical professional's hand positioned to move the cap from an initial position suitable for engagement with a female connector to a folded or retracted position suitable for engagement with a male connector, according to an embodiment of the present disclosure. [Figure 5A] FIG. 5A is a front view of a universal cap in a collapsed or retracted position for use with a male connector, according to one embodiment of the present disclosure. [Figure 5B] FIG. 5B is a cross-sectional view of the universal cap of FIG. 5A with the cap in a folded or retracted position. [Figure 5C] FIG. 5C is a close-up perspective view of the bottom of the cap in a folded or retracted position according to one embodiment of the present disclosure. [Figure 6A] 6A is a perspective view of the universal cap of FIG. 5A in a folded or stored position and the male needleless connector prior to insertion of the male needleless connector into the cap, according to one embodiment of the present disclosure. [Figure 6B] 6B is a cross-sectional view of the universal cap and male needleless connector of FIG. 6A. [Figure 6C] 6C is a perspective view of a cross section of the universal cap and male needleless connector of FIG. 6A. [Figure 7A] 7A is a cross-sectional view of a universal cap connected to the male needleless connector of FIG. 6A and in a folded or retracted position according to one embodiment of the present disclosure. [Figure 7B] 7B is another cross-sectional view of the male needleless connector connected to the cap of FIG. 6A according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0051] The following description is provided to enable any person skilled in the art to make and use the described embodiments intended to practice 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.

[0052] Hereinafter, for purposes of description, the terms "upper," "lower," "right," "left," "vertical," (horizontal), "top," "bottom," "lateral," "longitudinal," and their derivatives shall refer to the invention as oriented in the drawings. It will be understood, however, that the invention may assume various alternative modifications unless expressly specified to the contrary. It will 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 invention. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered limiting.

[0053] The present disclosure is directed to an exemplary universal cap 10 configured to be connected by a medical practitioner 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, for example, by microorganisms, debris, or other contaminants. The medical practitioner may be a clinician or medical worker who performs procedures, such as infusions or IV drips, on a patient. In particular, a "healthcare worker" may be a medical professional, such as a medical technician or nurse, who may be trained to perform medical procedures in accordance with the sterile practices and procedures of a medical facility.

[0054] In some examples, the cap 10 can be configured to clean or disinfect a portion of 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 allowed by aseptic practice guidelines in many medical facilities.

[0055] (Male and female needleless connectors) The cap 10 of the present disclosure is a universal cap configured to engage or connect with medical connectors 110, 112 of different sizes, configurations, and / or types. For example, the cap 10 can be configured to engage or connect with both male and female connectors 110, 112. As used herein, a "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. 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 to connect the other object or device to the female connector 112. The female connector 112 can include an elongated distal end portion 108 having a cover or septum 118 that covers the opening 116. FIG. 1B shows an exemplary female connector 112 that includes a septum 118 with a slit 120.

[0056] In some examples, cap 10 is configured to engage with different types of luer connectors, such as both male luer connector 110 and female luer connector 112. For example, cap 10 may be appropriately sized to accept a female luer connector 112 having an outer diameter of about 7.0 mm to about 10.0 mm. Cap 10 may also be sized to accept a male luer connector 110 having an outer diameter of about 8.0 mm to about 14.0 mm.

[0057] As used herein, "luer connector" refers to a connector that includes a tapered portion (e.g., luer taper) for creating frictional engagement between the tapered stem 114 or elongated member of the male luer connector 110 and the tapered cavity. For example, 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.

[0058] In some examples, the male connector 110 and the female connector 112 can include engagement structures such as threads for drawing the connectors 110, 112 into another connector or port. 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 includes threads 128 extending from its outer surface 130 arranged 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 facilitate twisting the female connector 112 relative to another connector or device.

[0059] There are numerous commercially available medical devices, such as hubs, ports, and valves, that include different variations of male or female connectors 110, 112, such as male and female Luer connectors. As described in further detail herein, the cap 10 of the present disclosure includes a flexible housing that can bend or deformed to form a secure, fluid-tight engagement with a variety of different types and sizes of connectors 110, 112. For example, the cap 10 can be configured to attach to both male and female Luer connectors 110, 112, such as male or female Luer-Lok™ connectors by Becton, Dickinson and Company. The cap 10 can also be configured to accommodate different connector designs, including, but not limited to, needle-free connectors such as BD Q-Syte®, BD MaxZero®, BD MaxPlus®, and SmartSite® by Becton, Dickinson and Company. 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 MED12664-28, RyMed RYM-5307HPU, B.Braun 470108, Baxter 2C8537, Kawasumi IV-0094, Zyno B2-70071-D, B.Braun 470124, Baxter 2C7462, and Smith's Medical 536035.

[0060] (Universal cap for male and female connectors) 2A-2C and 5A-5C illustrate an exemplary universal cap 10 configured to engage and / or connect to different types of connectors, such as any of the male connectors 110 and female connectors 112 described above. Specifically, FIG. 2A is a perspective view of the cap 10 showing the cap 10 in an initial or extended position, where the cap 10 is configured to connect to a female needleless connector 112. FIG. 2B is a cross-sectional view of the cap 10 in the initial position. FIG. 2C is a cross-sectional view of the housing 12 of the cap 10 in the initial position.

[0061] As described in further detail herein, the cap 10 may also be configured to move from an initial position to a second, retracted, or folded position (shown in FIGS. 5A-5C) suitable for connection to a male needleless connector 110. In particular, FIG. 5A is a perspective view of the cap 10 in the folded position. FIG. 5B is a cross-sectional view of the cap 10 in the folded position. FIG. 5C is a perspective view showing the bottom of the cap 10 in the folded position.

[0062] In some examples, the cap 10 can be provided as a single pre-packaged cap or cap assembly, such as the packaged cap shown in Figure 2B. Additionally, as described in further detail herein, the cap 10 includes components such as a sponge, an abrasive surface, and / or cleaning or disinfecting solution for cleaning, scrubbing, and disinfecting portions of the male and female connectors 110, 112 inserted and attached to the cap 10.

[0063] As shown in FIGS. 2A-2C, 5A, and 5B, cap 10 comprises a housing 12 including a first or top end 14, an open second or bottom end 16, and a sidewall 18 extending between top end 14 and bottom end 16. Housing 12 also includes a radially extending disk, plate, member, or flange 20 extending radially outward from sidewall 18 or open bottom end 16 of housing 12. As shown in the figures, flange 20 is a generally disk-shaped structure having an upwardly facing surface 22 and a downwardly facing surface 24. Upward surface 22 can be slightly sloped or angled. In contrast, downwardly facing surface 24 can be flat, allowing cap 10 to be placed on a vertically flat surface. Housing 12 and flange 20 can be integral parts of a single molded part formed, for example, by a single injection molding process. Generally, the housing 12 and flange 20 are formed from a flexible and / or deformable material to facilitate moving the housing 12 from its initial position to its folded position. For example, the housing 12 and / or flange 20 can be formed from a thermoplastic polymer such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, and / or acrylonitrile butadiene styrene. In some examples, the housing 12 can be formed from a durable material, such as a material with a Shore D hardness of 95 (Shore D) or less. Alternatively, the housing 12 can be formed from a more flexible material, such as a material with a Shore A hardness of 130 (Shore A) or less.

[0064] As described in further detail herein, flange 20 can be configured to allow a practitioner to press downwardly on a downwardly facing surface 24 of flange 20, optionally in combination with pressing downwardly on top end 14 of housing 12, to move housing 12 from an initial position to a folded position. In particular, moving housing 12 to the folded position causes side wall 18 of housing 12 to invert or fold along fold lines or notches 40, such that in the folded position shown in FIGS. 5A-5C , flange 20 surrounds a portion of side wall 18 at a location intermediate top end 14 and bottom end 16 of housing 12. Also, in the folded position, outer surface 30 of lower portion 36 of side wall 18 faces outer surface 30 of upper portion 38 of side wall 18.

[0065] As used herein, the "lower portion" of the side wall 18 refers to the portion of the side wall 18 between the fold line or notch 40 and the bottom end 16 of the housing 12. In contrast, the "upper portion" of the side wall 18 refers to the portion of the side wall 18 between the fold line 40 and the top end 14 of the housing 12. In some examples, the fold line 40 may be a printed marking that indicates to the practitioner how far the side wall 18 should be folded to use the cap 10 with the male needleless connector 110. In other examples, the fold line 40 may be a physical structure, such as a notch, groove, thinned portion, or flexible region, provided in or on the side wall 18 between the upper portion 38 and the lower portion 36 to facilitate folding of the side wall 18 to move the housing 12 from its initial position to its folded position. The shape or configuration of the side wall 18 may also facilitate folding of the side wall 18 to move the housing 12 from its initial position to its folded position. For example, the wall thickness of the lower portion 36 of the side wall 18 can be less than the wall thickness of the upper portion 38 of the side wall 18, making the lower portion 36 of the side wall 18 easier to manipulate, bend, and fold when moving the housing 12 from the initial position to the folded position.

[0066] The housing 12 of the cap 10 is a generally elongated tubular structure, although the housing 12 may include various structural features for aesthetic or functional purposes. For example, as shown, the upper end 14 of the housing 12 may include a domed outer surface 32 and a substantially flat inner surface 34.

[0067] In some examples, the housing 12 includes internal structure for creating or reinforcing the engagement between the connectors 110, 112 and the cap 10. For example, as shown most clearly in FIG. 2C , the cap 10 can include one or more annular ridges, protrusions, surfaces, or members extending radially inward from the inner surface 28 of the sidewall 18. In some examples, the annular ridges or protrusions can be molded structures or members formed on the inner surface 28 of the sidewall 18 during molding. In other examples, the annular ridges can be separate structures embedded in or attached to the inner surface 28 of the sidewall 18. For example, the annular ridges can be O-rings 42 disposed around the inner surface 28 of the sidewall 18. In some examples, the O-rings 42 can be inserted or secured in an annular groove in the inner surface 28 or held in place against the inner surface 28 of the sidewall 18 by adhesives, mechanical fasteners, or other connectors, as known in the art. In either case, the annular ridge or O-ring 42, if present, is configured to press against the outer surface 130 and / or threads 128 of the female connector 112, thereby forming a frictional or interference engagement with the female connector 112 to secure the cap 10 to the female connector 112. The annular ridge or O-ring 42 can also contribute to forming a fluid-tight seal that prevents cleaning or disinfecting solutions within the cap 10 from leaking past the surface of the female connector 112 and out of the cap 10.

[0068] The cap 10 further includes an absorber, absorbent member, or support structure (referred to herein as absorbent member 26) inserted into the cap 10 for cleaning and disinfecting portions of the male and female connectors 110, 112, such as the threaded surfaces of the connectors 110, 112 (e.g., the roots and crests of the threads 124, 128). In particular, the absorbent member 26 can be configured to clean and disinfect the surface of the stem 114, as well as the inner surface 126 of the annular shield 122 and the threads 124 of the male connector 110. The absorbent member 26 can also be configured to clean and disinfect the distal end portion 108, opening or port 116, and a portion of the septum 118 of the female connector 112.

[0069] As shown in FIG. 2B , the absorbent member 26 can be a substantially tubular or cylindrical structure including an upper end 46, a lower end 48, and a cylindrical body 44 extending therebetween. The body 44 can be seated and / or received within a corresponding cylindrical cavity or portion of the housing 12. In some examples, the absorbent member 26 can be retained within the housing 12 by frictional engagement between the absorbent member 26 and the inner surface 28 of the sidewall 18. In such cases, the outer diameter D1 of the absorbent member 26 can be the same as or substantially match (e.g., by about 5% or less) the inner diameter D2 of the upper portion 38 of the sidewall 18 of the housing 12 to ensure a strong frictional engagement between the sidewall 18 and the absorbent member 26. In other examples, the absorbent member 26 can be held in place within the housing 12 by conventional adhesives or mechanical fasteners, as known in the art. 2A-2C, when the housing 12 is in the initial position, the absorbent member 26 is completely surrounded or enclosed by the housing 12 and is accessible through the open bottom end 16 of the housing 12. In contrast, as shown in FIGS. 5A-5C, when the cap 10 is in the collapsed position, the lower portion 52 of the absorbent member 26 protrudes distally beyond the folded side wall 18 of the housing 12. For example, the lower portion 52 of the absorbent member 26 can protrude beyond the side wall 18 a distance D4 of about 3 mm to about 6 mm.

[0070] 2B, 5B, and 5C, the absorbent member 26 includes a cutout, cavity, opening, gap, or slit 50 extending axially through the cylindrical body 44 of the absorbent member 26. In particular, the slit 50 can extend axially through the body 44 from the interior of the body 44 to the lower end 48 of the body 44. The slit 50 cannot extend entirely through the body 44 and / or cannot extend all the way to the upper end 46 of the body 44. The absorbent member 26, including the body 44 separated by the slit 50, is configured to engage with and clean a portion of the male connector 110. In particular, the slit 50 can be positioned to receive the stem 114 of the male luer connector 110. Specifically, the stem 114 can be advanced axially through the slit 50, separating a portion of the body 44 to receive the stem 114 of the male luer connector 110 and form a frictional engagement between the inner surface of the absorbent member 26 and the outer surface of the stem 114.

[0071] In some examples, the absorbent member 26 includes or is 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. Additionally, the absorbent member 26 can be configured to compress axially when the distal portions of the connectors 110, 112 are inserted into the housing 12. The axial compression of the absorbent member 26 can cause cleaning solutions to flow away from the absorbent member 26 and contact the threads 124, 128 and other surfaces of the connectors 110, 112 for cleaning and disinfecting portions of the connectors 110, 112.

[0072] In some examples, the absorbent member 26 can include a thermoplastic elastomer, such as polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene). The absorbent member 26 can also include a porous foam (e.g., open-cell foam) or sponge capable of absorbing cleaning or disinfecting solutions, such as a foam or sponge comprising polyurethane. For example, the foam material can be Plastazpte® foam, an engineering polymer foam from Zotefoams PCL.

[0073] In some examples, the absorbent member 26 can be provided (e.g., pre-soaked) with a cleaning or disinfecting solution. For example, the cleaning or disinfecting solution can be an antibacterial, antifungal, antibacterial, or antiviral solution that cleans and disinfects 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 in combination with about 70% IPA. The chlorhexidine composition can be beneficial because it evaporates more slowly than IPA, thereby providing a more sustained disinfecting effect after the cap 10 is removed from the connector 110, 112 and before the VAD is connected to a hub, port, or valve.

[0074] In some examples, as shown most clearly in FIG. 5B , the cap 10 further includes a protrusion 56 extending inward from the flat inner surface 34 of the housing 12 toward the absorbent member 26. The protrusion 56 may be a frustoconical structure including sloping or angled sides and a flat base. As shown in FIG. 7B , the flat base may be sized to cover and / or seal the opening in the stem 114 of the male connector 110 when the male connector 110 is inserted into the cap 10. The protrusion 56 is provided to prevent liquids, such as cleaning solutions, from passing into the fluid passages or channels of the male connector 110, which could contaminate fluid or patient lines extending through the male connector 110, for example.

[0075] In some examples, the cap 10 further includes a removable and / or disposable protective cover 54 (shown in FIG. 2B ) disposed over the open bottom end 16 of the housing 12. Specifically, as shown in FIG. 2B , the protective cover 54 can extend over the open bottom end 16 and contact, connect, and / or adhere to the downward-facing surface 24 of the flange 20. The protective cover 54 can be provided to protect components and portions of the cap 10, such as the housing 12 and absorbent member 26, during shipping and storage to prevent contamination and to prevent evaporation of the cleaning or disinfecting solution prior to use. In some examples, the protective cover 54 can include a sheet, such as a polymeric film, having an adhesive on a first side thereof for removably attaching the protective cover 54 to the downward-facing surface 24 of the flange 20. Alternatively, the protective cover 54 can be removably attached to the downward-facing surface 24 of the flange 20 by heat sealing. The protective cover 54 can be formed from an airtight or substantially airtight material to prevent evaporation or drying of the cleaning or disinfecting solution on the absorbent member 26. Thus, the protective cover 54 can extend the shelf life of the cap 10 and prevent microorganisms and other debris from collecting within the cap 10 prior to use.

[0076] As previously mentioned, the cap 10 is configured to form a frictional and / or interference engagement with female and male connectors 110, 112 of different configurations and types. Thus, while portions of the housing 12 may be deformable to account for size differences, the dimensions of the cap 10 are generally selected to ensure a good frictional fit between the cap 10 and expected conventional or commonly sized connectors 110, 112. For example, the cap 10 is configured to engage the female connector 112 through interference or frictional engagement between the inner surface 28 of the sidewall 18 and the outer surface 130 of the distal portion 108 of the tubular member 114 and / or the external threads 128 of the female connector 112. To form a good frictional and / or interference engagement, the outer diameter D3 (shown in FIGS. 3A and 3B ) of the distal end portion 108 of the female connector 112 and / or the threads 128 of the tubular member 114 is greater than the maximum inner diameter D7 (shown in FIG. 3B ) of the housing 12. Similarly, cap 10 is configured to engage male connector 110 in the folded position by interference or frictional engagement between a portion of folded side wall 18 and inner surface 126 or threads 124 of annular shield 122 of male luer connector 110, for example, as shown in Figures 7A and 7B. To form a good frictional and / or interference engagement with male connector 110, maximum outer diameter D5 (shown in Figures 6B and 7B) of side wall 18 of housing 12 can be larger than inner diameter D6 (shown in Figures 6B and 7B) of threads 124 or inner surface 126 of annular shield 122 to ensure that side wall 18 of cap 10 is secured within annular shield 122.

[0077] (How to attach the connector to the cap) As mentioned above, the cap 10 of the present disclosure is a universal cap 10 configured to be connected to various types and sizes of male connectors 110 and female connectors 112. For example, FIGS. 3A and 3B show the cap 10 connected to the female connector 112. FIG. 4 shows the cap 10 being moved from an initial position suitable for connecting the cap 10 to the female connector 112 to a folded position suitable for connecting the cap 10 to the male connector 110. FIGS. 6A-7B show the cap 10 in the folded position connected to the male connector 110.

[0078] To connect the cap 10 to the tall female connector 112, the practitioner first removes the packaging from the cap 10 and removes the protective cover 54 from the open bottom end 16 of the housing 12. Once the packaging and protective cover 54 are removed, the practitioner moves the female connector 112 toward the open bottom end 16 of the housing 12. For example, in the case of the female connector 112, the practitioner moves the female connector 112 toward the housing 12, bringing the septum 118 of the female connector 112 into contact with the absorbent member 26. As previously mentioned, contact between the polished surface of the absorbent member 26 and the surface of the female connector 112 can mechanically remove particles, such as microorganisms and other debris, from the surface of the female connector 112, which contributes to the cleaning effect provided by the cap 10.

[0079] Continuing to move the female connector 112 into the housing 12 allows the outer surface 130 and threads 128 of the tubular distal portion 108 of the female connector 112 to come into contact with the absorbent member 26. Continued movement of the female connector 112 into the housing 12 also axially compresses the absorbent member 26, releasing the cleaning and / or disinfecting solution into the interior of the housing 12. As previously described, the released cleaning and / or disinfecting solution contacts, cleans, and disinfects portions of the female connector 112, including the septum 118, as well as the outer surface 130 and threads 128 of the tubular distal portion 108 of the female connector 112.

[0080] To remove the cap 10 from the female connector 112, the practitioner grasps the sidewall 18 and / or flange 20 of the cap 10 and pulls the cap 10 axially away from the female connector 112. Beneficially, as mentioned above, the housing 12 does not include threads. Thus, the practitioner does not need to twist or rotate the female connector 112 relative to the cap 10 to remove it from the cap 10. Instead, the practitioner simply moves the female connector 112 axially away from the cap 10 to remove it. Once removed, the cap 10 can be discarded, as it is often a disposable product.

[0081] Once the female connector 112 is completely removed from the housing 12, the female connector 112 can be connected to the VAD. For example, the female connector 112 can be attached to or inserted into a hub, port, or valve of the VAD, forming a needleless, fluid-tight connection between the female connector 112 and a fluid pathway, channel, or lumen of the VAD.

[0082] As previously mentioned, the universal cap 10 can also be connected to a male connector 110, as shown in FIGS. 6A-7B. To connect the cap 10 to the male connector 110, a practitioner must first move the housing 12 of the cap 10 from its initial position (shown in FIGS. 2A-2C) to its folded position (shown in FIGS. 5A-5C). As shown in FIG. 4, to move the cap 10 to its folded position, a practitioner grasps the cap 10 and pushes the cap 10 and / or flange 20, causing the side walls 18 to align with the fold lines or notches 40 and into their folded position. For example, as shown in FIG. 4, a practitioner can press the top end 14 of the housing 12 with a thumb 134, exerting a downward force F1. The practitioner also presses against the downward surface 24 of the flange 20 with a finger (e.g., an index finger 136), exerting an upward force F2 against the flange 20. The resultant downward force F1 and upward force F2 cause side wall 18 to invert or fold, thereby moving housing 12 of cap 10 to the folded position.

[0083] Once the cap 10 is in the collapsed position, it can be connected to a male connector 110, as shown in FIGS. 6A-7B . Specifically, to connect the cap 10 to the male connector 110, the practitioner moves the cap 10 toward the male connector 110, bringing the lower portion 52 of the absorbent support 26 into contact with the stem 114 of the male connector 110. Continuing to move the male connector 110 into the cap 10 inserts the stem 114 into the slit 50 of the absorbent member 26. Once inserted into the slit 50, the inner surface of the absorbent member 26 contacts the outer surface of the stem 114 to scrub or mechanically remove particles, dirt, dust, microorganisms, and other debris from the outer surface of the stem 114. Continuing to move the male connector 110 into or toward the cap 10, the practitioner then inserts the side wall 18 of the cap 10 into the annular shield 122 of the male connector 110. As previously mentioned, when cap 10 is inserted into annular shield 122, the folded outward surface on side wall 18 of housing 12 contacts inner surface 126 and / or threads 124 of annular shield 122, forming a frictional engagement to connect cap 10 to male connector 110. Additionally, cleaning and / or disinfecting solution released from absorbent member 26 can contact inner surface 126 and threads 124 of annular shield 122 to clean and disinfect these surfaces.

[0084] The cap 10 can be removed from the male connector 110 in a manner similar to how the cap 10 is removed from the female connector 112. For example, a practitioner can grasp the annular shield 122 of the male connector 110 with one hand and grasp the side wall 18 and / or flange 20 of the cap 10 with the other hand. The practitioner then moves the cap 10 axially away from the male connector 110, thereby releasing the cap 10 from the male connector 110. Once the cap 10 is released from the male connector 110, the cap 10 can be discarded, and the male connector 110 can be attached to a port or hub of a VAD, as described above.

[0085] Although examples of the universal cap 10 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 invention. Accordingly, the foregoing description is intended to be illustrative rather than limiting. The invention 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 a first connector and a second connector of different types, a housing comprising a first end, an open second end, at least one sidewall extending between the first end and the second end, and a radially extending flange extending outward from the at least one sidewall or the open second end; an absorbent member disposed within the housing configured to contain a cleaning solution for cleaning and / or disinfecting a portion of the first connector or the second connector that is engaged with the cap; A cap configured to engage with at least a first connector and a second connector of different types, wherein the housing is configured to move between a first position in which the housing is configured to engage with the first connector and a second position in which the housing is configured to engage with the second connector by folding at least one side wall of the housing so that the flange surrounds a portion of at least one side wall between the first end and the second end of the housing in the second position.

2. The first connector comprising a female luer connector, a tubular body defining a tapered cavity sized to receive the stem of a male luer connector; a partition covering an opening of the tubular body; external threads extending radially outward from an outer surface of the tubular body; 2. The cap of claim 1, wherein the cap is engaged to the female connector by interference or frictional engagement between an inner surface of the at least one side wall and the outer surface of the tubular body and / or the external threads of the female connector.

3. the second connector comprises a male luer connector; a stem including a proximal end, a distal end and a tapered outer surface extending therebetween, the stem defining a fluid channel extending therethrough; an annular shield around the stem connected to the proximal end of the stem; a thread extending inwardly from an inner surface of the annular shield; 10. The cap of claim 1, wherein the cap covers a side wall and is engaged to the male connector by interference or frictional engagement between at least one folded portion and the inner surface of the annular shield of the male luer connector.

4. The cap of claim 1 , wherein the first end of the housing comprises a domed outer surface and a substantially flat inner surface.

5. The cap of claim 1 , wherein in the second position, an outer surface of a lower portion of the at least one side wall faces an outer surface of an upper portion of the at least one side wall.

6. 6. The cap of claim 5, wherein the at least one side wall comprises a notch or groove in the at least one side wall between the upper and lower portions to facilitate folding of the at least one side wall to move the housing from the first position to the second position.

7. The cap of claim 5 , wherein the housing further comprises a plurality of annular ridges comprising O-rings extending radially inward from an inner surface of the lower portion of the at least one side wall.

8. The cap of claim 5 , wherein the wall thickness of the lower portion of the at least one side wall is less than the wall thickness of the upper portion of the at least one side wall.

9. The cap of claim 1 , wherein the absorbent member is axially compressed when the first connector or the second connector is inserted into the housing.

10. 10. The cap of claim 9, wherein the axial compression of the absorbent member causes the cleaning fluid in the absorbent member to contact threads and a surface of the first connector or the second connector.

11. 2. The cap of claim 1, wherein the absorbent member comprises a cylindrical body having an outer diameter substantially corresponding to a smallest inner diameter of the housing, and a slit extending axially through the cylindrical body.

12. The cap of claim 11 , wherein the slit extends axially through the cylindrical body to a distal end of the cylindrical body.

13. 13. The cap of claim 12, wherein the portions of the cylindrical body separated by the slit are configured to separate to receive the stem of a male luer connector.

14. 2. The cap of claim 1, wherein when the housing is in the first position, the absorbent member is enclosed within the housing and accessible through the second open end of the housing, and when the cap is in the second position, a lower portion of the absorbent member protrudes beyond the at least one folded over side wall of the housing.

15. The cap of claim 1 , further comprising a cleaning solution absorbed by the absorbent member, the cleaning solution comprising isopropyl alcohol (IPA) and / or chlorhexidine gluconate.

16. 10. The cap of claim 1, wherein the housing is moved from the first position to the second position by applying a downward force to the first end of the housing and / or by applying an upward force to a distal surface of the flange.

17. 10. A method for attaching the cap of claim 1 to the second connector, the method comprising: folding the housing onto the at least one side wall of the cap so that the housing moves from the first position to the second position; and inserting a second connector into the folded overcap such that a stem of the second connector is received within a slit extending axially through the absorbent member.

18. the second connector comprises a male luer connector; a stem including a proximal end, a distal end and a tapered outer surface extending therebetween, the stem defining a fluid channel extending therethrough; an annular shield around the stem connected to the proximal end of the stem; a thread extending inwardly from an inner surface of the annular shield; 18. The method of claim 17, wherein an inner diameter defined by the threads of the annular shield is less than a maximum outer diameter of the housing when the housing is in the second position.

19. 10. A method of attaching the cap of claim 1 to the first connector, comprising inserting an end of the first connector into the cap, placing the housing in the first position so that the tubular body and / or other threads of the female connector contact the absorbent member.

20. 20. The method of claim 19, wherein an outer diameter of the tubular body of the first connector is greater than a maximum inner diameter of the housing.

Images