Disinfection cap for needleless connectors with multi-part housing and automatic lock

Abstract

A disinfection cap for a needleless connector includes an outer housing having a sidewall and an outer guide on an interior surface of the sidewall. The cap also includes an inner housing having an open end sized to receive the distal end of the needleless connector, a sidewall, and an inner guide on an outer surface of the sidewall, the inner guide interacting with the outer guide of the outer housing. The cap also includes an absorbent member disposed in the inner housing, the absorbent member configured to contain a cleaning solution for cleaning and / or disinfecting a portion of the needleless connector joined to the cap. Movement of the inner guide relative to the outer guide causes the inner housing to move axially into the outer housing and alternate between rotation in a first direction and rotation in a second direction relative to the outer housing.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Utility Application No. 18 / 084,639, filed on December 20, 2022, entitled “Disinfecting Cap for Needleless Connectors with Multi-Part Housing and Automatic Lock,” the entire disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0002] The present disclosure relates generally to caps for medical connectors, and particularly to caps configured to be attached to needleless connectors for sealing, cleaning or swabbing, and disinfecting portions of the connector. Background Art

[0003] Vascular access devices (VADs) are commonly used medical devices that may include intravenous (IV) catheters, such as peripheral catheters or central venous catheters. If improperly maintained or if exposed to a non-sterile environment, VADs can become contaminated, become clotted, and / or transmit infection. Furthermore, when connected to a VAD to deliver fluids or medications to a patient, bacteria and other microorganisms can enter the patient's vascular system from the access hub, port, or valve. Consequently, every access hub, port, valve, or other connector configured for attachment to a VAD is associated with some risk of transmitting a catheter-related bloodstream infection (CRBSI) to the patient.

[0004] Many medical institutions implement aseptic practices and protocols to ensure that the VAD and access hub or port are used correctly and do not become sealed or infected. These protocols often include sterilizing the access hub, port, and VAD, and flushing the catheter with a flushing solution before use. Specifically, VAD practice standards generally recommend performing a flushing procedure after catheter placement, before fluid infusion, and before and after drug administration, blood sampling, transfusion, and / or parenteral nutrition administration. Practice standards may also require that the access hub, port, and valve be covered with a sterile cap when not in use to prevent microorganisms from invading the hub, port, or valve, and to sterilize the area of the hub, port, or valve that contacts the VAD. A sterile cap is a disposable cap device that contains a certain amount of cleaning or disinfecting solution for sterilizing various parts of the port, hub, and valve. The sterile cap may also include an abrasive surface, insert, component, or structure for mechanically removing particles, such as dust, dirt, microorganisms, cells, and other debris, from the surface of the hub or port of the VAD. In particular, mechanically removing or scrubbing biological materials, such as microorganisms and cells, from the surfaces of the hub and ports more fully exposes these materials to the cleaning or disinfecting solution to destroy these biological materials.

[0005] Access hubs and ports can have a variety of different types of connectors for securing the hub or port to the VAD. Currently, practitioners often carry several types of caps so they can cover the different types of interfaces and ports available for 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 may be a "male sterilization cap set" for sterilizing an ISO 594-2 type female threaded fluid Luer connector and a "female sterilization cap set" for sterilizing an ISO 594-2 type male threaded fluid Luer connector.

[0006] Some 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 Fittings," which is incorporated herein by reference in its entirety, discloses a cap that includes threaded protrusions that can engage both male and female connectors. However, a simpler cap design is needed that can be manufactured inexpensively and efficiently and that can be used with connectors having a variety of thread patterns, sizes, and arrangements. The disinfection cap of the present disclosure is configured to attach to a variety of different types of needleless connectors in a manner that is secure enough to prevent the ingress of microorganisms. Summary of the Invention

[0007] According to one aspect of the present disclosure, a disinfection cap for a needleless connector includes an outer shell having a first end, an open second end, a sidewall extending between the first and second ends, and at least one external guide on the inner surface of the sidewall. The cap also includes an inner shell having a first end, an open second end sized to receive the distal end of the needleless connector, a sidewall extending between the first and second ends, and at least one inner guide on the outer surface of the sidewall that interacts with the at least one external guide of the outer shell. The cap also includes at least one absorbent member disposed in the inner shell, the absorbent member being configured to contain a cleaning solution for cleaning and / or disinfecting the portion of the needleless connector that is coupled to the cap. Movement of the at least one internal guide relative to the at least one external guide causes the inner shell to move axially into the outer shell and alternate between rotating in a first direction and rotating in a second direction relative to the outer shell.

[0008] According to an embodiment of the invention, the inner housing is configured to move between an extended position in which the second end of the inner housing is located outside the outer housing and a retracted position in which the inner housing is completely located within the outer housing.

[0009] According to an embodiment of the present invention, as the inner housing moves from the extended position to the retracted position, movement of the at least one inner guide relative to the at least one outer guide causes the inner housing to rotate back and forth multiple times as it advances to the retracted position.

[0010] According to an embodiment of the present invention, the inner housing rotates back and forth at least four times as it moves from the extended position to the retracted position.

[0011] According to an embodiment of the present invention, when the distal end of the needleless connector is inserted into the inner housing, the inner housing rotates back and forth about the distal end of the needleless connector as the inner housing moves from the extended position to the retracted position.

[0012] According to an embodiment of the present invention, the first direction is a clockwise direction, and the second direction is a counterclockwise direction.

[0013] According to an embodiment of the present invention, the needleless connector includes a female Luer connector.

[0014] According to one embodiment of the present invention, the cap is sized to receive a female connector having an outer diameter from about 8.0 mm to about 14.0 mm and threads having a width at the crest from about 0.3 mm to about 1.0 mm and a width at the crest root from about 0.5 mm to 1.2 mm.

[0015] According to an embodiment of the present invention, a female Luer connector includes: a tubular body defining a tapered cavity; a septum covering an opening of the tubular body; and external threads extending radially outward from an outer surface of the tubular body, wherein when the female Luer connector is inserted into the cap, at least one absorbent member is configured to contact the outer surface of the female Luer connector, the external threads, and the septum.

[0016] According to an embodiment of the invention, the at least one outer guide comprises a track extending inwardly from an inner surface of a side wall of the outer housing, and wherein the track comprises alternating segments for rotation in a first direction connected in series with segments for rotation in a second direction.

[0017] According to an embodiment of the invention, the track comprises a groove or slot extending into a side wall of the outer housing.

[0018] According to an embodiment of the invention, the at least one inner guide comprises a protrusion extending radially outward from an outer surface of a side wall of the inner housing received within the track of the outer housing.

[0019] According to one embodiment of the present invention, the track further comprises a longitudinally extending groove or slot extending between the open second end of the outer housing and the distal end of one of the segments of the track, positioned to receive at least one inner guide as the inner housing is inserted into the outer housing.

[0020] According to one embodiment of the invention, the section of the track extends non-helically around the interior surface of the outer casing for less than one full turn.

[0021] According to one embodiment of the present invention, each alternating segment rotates the inner housing about the longitudinal axis of the inner housing by an angular distance of about 4 degrees to about 45 degrees.

[0022] According to an embodiment of the present invention, rotation of the inner housing about the needleless connector inserted into the inner housing causes the at least one absorbent member to scrub the needleless connector inserted into the inner housing.

[0023] According to an embodiment of the present invention, the inner housing forms an interference and / or frictional engagement with the needleless connector that secures the inner housing to the needleless connector.

[0024] According to an embodiment of the invention, at least one outer guide comprises a first track and a separate second track on opposite sides of an inner surface of a side wall of the outer housing, and wherein the first track and the second track are symmetrical about a longitudinal axis of the outer housing.

[0025] According to an embodiment of the present invention, at least one inner guide comprises a first protrusion extending from an outer surface of a side wall of the inner housing received in the first track and a second protrusion extending from an outer surface of the side wall of the inner housing received in the second track of the outer housing.

[0026] According to an embodiment of the invention, the inner housing and / or the outer housing comprises a thermoplastic polymer material, such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate or acrylonitrile butadiene styrene.

[0027] According to one embodiment of the present invention, the outer shell further comprises at least one protrusion which is pressed into a recessed position when the inner shell is in the extended position, and which moves to a blocking position preventing the inner shell from being removed from the outer shell when the inner shell is inserted into the outer shell and moves toward the retracted position.

[0028] According to an embodiment of the present invention, at least one projection is pivotally connected to an interior surface of a side wall of the outer housing and is biased to pivot away from the interior surface of the side wall to a blocking position.

[0029] According to an embodiment of the present invention, the outer shell includes a plurality of protrusions, which are biased to a recessed position when the inner shell is in the extended position, and when the inner shell is inserted into the outer shell and moved toward the retracted position, the protrusions move to a blocking position that prevents the inner shell from being removed from the outer shell.

[0030] According to an embodiment of the present invention, the plurality of protrusions include a plurality of elongated members having a first end connected to the side wall of the outer housing and a second end configured to protrude into a space defined by the side wall of the outer housing to block removal of the inner housing from the outer housing.

[0031] According to an embodiment of the present invention, when the inner housing is inserted into the outer housing, the at least one protrusion automatically moves from the recessed position to the blocking position.

[0032] According to one embodiment of the invention, the at least one absorbent member is a cylinder having a circular first end, a circular second end and a cylindrical sidewall extending therebetween.

[0033] According to an embodiment of the invention, the at least one absorbent member comprises a sponge.

[0034] According to one embodiment of the invention, at least one absorbent member comprises an open-cell foam, such as a porous foam comprising a thermoplastic elastomer.

[0035] According to one embodiment of the invention, the cleaning solution is absorbed by at least one absorbent member.

[0036] According to one embodiment of the present invention, the cleaning solution includes isopropyl alcohol (IPA).

[0037] According to an embodiment of the present invention, the cleaning solution includes about 0.5% to about 3.5% chlorhexidine gluconate and about 70% IPA.

[0038] According to an embodiment of the invention, the protective cover on the open second end of the inner housing serves to seal the inner housing from contamination of the at least one absorbent member and / or evaporation of the cleaning solution absorbed by the at least one absorbent member.

[0039] According to an embodiment of the invention, the protective cover is attached to the inner casing by heat sealing.

[0040] According to an embodiment of the present invention, the removable clip is configured to connect to the exterior surface of the inner housing when the inner housing is in the extended position, which prevents the inner housing from being inserted into the outer housing until the clip is removed from the exterior surface of the inner housing.

[0041] According to an embodiment of the present invention, the removable clamp includes a C-shaped clamp configured to grasp and engage an exterior surface of the inner housing.

[0042] According to an embodiment of the present invention, the removable clamp further includes a handle extending from the C-shaped clamp for manipulating the removable clamp.

[0043] According to another aspect of the present disclosure, a method for manufacturing a disinfection cap as previously described includes: forming a first component of an outer shell in a first mold; forming a second component of the outer shell in a second mold; attaching the first component to the second component by ultrasonic welding to form the outer shell, forming an inner shell by a single molding process, inserting at least one absorbent member into the inner shell, and inserting the inner shell into the formed outer shell.

[0044] According to another aspect of the present disclosure, as previously described, a method for using the disinfection cap includes: inserting the distal end of the needleless connector into the open second end of the inner shell so that the surface of the absorbent member contacts the distal end of the needleless connector; and pressing the outer shell toward the needleless connector so that the inner shell rotates relative to the outer shell and the needleless connector to scrub the surface of the needleless connector.

[0045] According to one embodiment of the present invention, a method of using the above-mentioned cap includes inserting the distal end of the needleless connector into the open second end of the inner housing so that the surface of the absorbent member contacts the distal end of the needleless connector, and pressing the outer housing toward the needleless connector so that the inner housing rotates relative to the outer housing and the needleless connector to scrub the surface of the needleless connector.

[0046] According to an embodiment of the present invention, the needleless connector is a female Luer connector.

[0047] According to an embodiment of the present invention, the method of using the cap further includes removing a protective cover positioned on the open second end of the inner housing from the inner housing before inserting the distal end of the needleless connector through the open second end of the inner housing. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] FIG. 1A is a cross-sectional view of an exemplary male connector known in the prior art.

[0049] FIG. 1B shows an example of a female connector known in the prior art, including a slitted diaphragm.

[0050] Figure 2A is a perspective view of a sterilization cap for a needleless connector in an initial or extended position according to one aspect of the present disclosure.

[0051] Figure 2B According to one aspect of the present disclosure Figure 2A Another perspective view of a sterilization cap of FIG. 1 , showing the open bottom portion of the cap in a final or retracted position.

[0052] Figure 2C yes Figure 2A Exploded view of the disinfection cap.

[0053] Figure 3A is in an initial or extended position according to one aspect of the present disclosure Figure 2A Front view of the sterilization cap.

[0054] Figure 3B Is in the middle or in use position Figure 2A Front view of the sterilization cap.

[0055] Figure 3C Is in its final or retracted position Figure 2A Front view of the sterilization cap.

[0056] Figure 4A According to one aspect of the present disclosure Figure 2A A perspective view of the inner housing of a sterilization cap showing the open bottom end of the inner housing.

[0057] Figure 4B and Figure 4C This is a diagram showing an aspect of the present disclosure. Figure 4A Schematic diagram of the pins of the internal housing.

[0058] Figure 5A FIG. 1 is a diagram showing an initial or extended position of a female needleless connector according to one aspect of the present disclosure. Figure 2A front view of the cap.

[0059] Figure 5B Is shown in close Figure 5A The initial or extended position of the female needleless connector Figure 2A perspective view of a hat.

[0060] Figure 5C FIG. 1 is a diagram showing an initial or extended position of a female needleless connector according to one aspect of the present disclosure. Figure 2A front view of the cap.

[0061] Figure 5D is a diagram showing an insertion into Figure 2A in the hat Figure 5C Cross-sectional view of a male pinless connector.

[0062] Figure 6A According to one aspect of the present disclosure, Figure 2A A perspective view of the outer shell of the disinfection cap.

[0063] Figure 6B yes Figure 6A A perspective view of a cross section of the outer casing.

[0064] Figure 6C According to one aspect of the present disclosure Figure 6A A front view of a portion of an outer housing showing projections deployed to prevent removal of the inner housing from the outer housing.

[0065] Figure 7A According to one aspect of the present disclosure Figure 2A A perspective view of a sterilization cap including a removable clamp coupled to the cap for maintaining the cap in an initial or extended position.

[0066] Figure 7B yes Figure 7A A perspective view of the removable clamp.

[0067] Figure 8A is a schematic diagram illustrating a mold for manufacturing components of an outer shell of a sterilization cap according to one aspect of the present disclosure.

[0068] Figure 8B Shows the use of Figure 8A A perspective view of the mold-made components of the outer housing.

[0069] Figure 8C According to one aspect of the present disclosure, Figure 8B A perspective view of the outer shell of a sterilization cap made by ultrasonic welding of components. DETAILED DESCRIPTION

[0070] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for implementing the present invention. However, various modifications, equivalents, variations, and alternatives will remain apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0071] For the purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives shall relate to the present invention as it is oriented in the accompanying drawings. However, it should be understood that the present invention may assume alternative variations and step sequences unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0072] The present disclosure relates to a cap 10 that is configured to be connected to a medical connector by a medical practitioner, such as to a male needleless connector 110 and / or to a female needleless connector 112, to prevent the connectors 110, 112 from being contaminated by, for example, microorganisms, debris, or other contaminants. In some examples, the connectors 110, 112 can be an access hub, port, or valve for a VAD. In other examples, the connectors 110, 112 can be an element of another medical device, such as a fluid delivery device, a syringe, a catheter hub, or another medical device known in the art. The medical practitioner using the cap 10 and connectors 110, 112 can be a clinician or a healthcare worker who performs a fluid delivery or infusion procedure for a patient. In particular, a "healthcare worker" can be a medical professional, such as a medical technician or a nurse, who is trained to perform a medical procedure according to the aseptic practices and protocols of a medical institution.

[0073] The cap 10 of the present disclosure is configured to clean and disinfect various parts of the connectors 110, 112, ensuring that the connectors 110, 112 remain sterile before use. As used herein, cleaning the connectors 110, 112 refers to exposing the surfaces of the connectors 110, 112 to a cleaning or disinfecting solution that destroys biological material (e.g., microorganisms and cells), and the action of mechanically removing particles (e.g., dust, dirt, microorganisms, cells, and other debris) from the surfaces of the connectors 110, 112, which can be referred to as "scrubbing" the connectors 110, 112. The cap 10 of the present disclosure may also include features that encourage practitioners to use the cap 10 to scrub the surfaces of the connectors 110, 112 in an appropriate manner. For example, as described in further detail herein, the cap 10 may include features that encourage practitioners to twist the cap back and forth multiple times on the distal ends of the connectors 110, 112, thereby mechanically removing particles from the surfaces of the connectors 110, 112. After scrubbing is complete, the cap 10 can be configured to remain in place on the connector 110, 112 or port for up to seven days, which is the maximum recommended usage time allowed by many medical institution aseptic practice guidelines. Once removed from the connector 110, 112, the cap 10 can include features that prevent reuse of the cap 10 and / or provide a visual indication to the practitioner that the cap 10 has been used and should not be used again. Male and female medical connectors

[0074] The cap 10 of the present disclosure can be a universal cap, meaning that it is configured to engage or connect with medical connectors of different sizes, configurations, and / or types. In particular, the cap 10 can be configured to engage or connect with a female connector 112. In some examples, the cap 10 can also be adapted or modified to connect to a male connector 110.

[0075] As used herein, a "male connector" refers to a connector 110 that includes an elongated member, such as a tubular member or rod 114, that is configured to be inserted into a tube or opening having an inner diameter that is larger than the outermost diameter of the male connector 110. An exemplary male connector 110 is shown in FIG1A. In contrast, a "female connector" refers to a connector 112 that includes an opening or port 116 that is configured to receive an elongated member or tubular member of another object or device in order to connect the object or device to the female connector 112. The female connector 112 can include an elongated distal end portion 108 having a covering or septum 118 over the opening 116. An exemplary female connector 112 including a septum 118 having a slit 120 is shown in FIG1B.

[0076] In some examples, the cap 10 is configured to engage different types of luer connectors, such as both a male luer connector 110 and a female luer connector 112. For example, the cap 10 can be sized to receive a female luer connector 112 having an outer diameter of about 7.0 mm to about 10.0 mm.

[0077] As used herein, a "luer connector" refers to a connector that includes a tapered portion (e.g., a luer taper) that is configured to create frictional engagement between a tapered shaft 114 or an elongated member and a tapered lumen of a male luer connector 110. For example, the male luer connector 110 can include a tapered shaft 114 or an elongated member having a tapered outer surface. The female luer connector 112 can include a tapered lumen configured to receive and engage the tapered shaft 114 or elongated member to connect the male luer connector 110 to the female luer connector 112.

[0078] In some examples, the male and female connectors 110, 112 can include engaging structures, such as threads, for pulling the connectors 110, 112 to another connector or port. For example, as shown in FIG1A , the male luer connector 110 can include an annular shield 122 or collar extending around the tapered shaft 114 or elongated member. The annular shield 122 can include threads 124 on an interior surface 126 of the annular shield 122 that are configured to engage corresponding threads 128 on an exterior surface 130 of the female luer connector 112. As shown in FIG1B , the female luer connector 112 includes corresponding threads 128 extending from the exterior surface 130 that are positioned to engage the threads 124 on the interior surface 126 of the annular shield 122 of the male luer connector 110. Twisting the female connector 112 relative to the male connector 110 causes the corresponding threads 128 to engage, which draws the connectors 110, 112 together, causing the tapered shaft 114 or elongated member of the male luer connector 110 to move through the opening 116 of the female connector 112. In some examples, the female connector 112 can also include vertical ribs 132 near the proximal end of the female connector 112, which can be used to manipulate the female connector 112, making it easier to twist the female connector 112 relative to another connector or device.

[0079] There are many 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 can be adapted to connect to needleless connectors 110, 112 of different types and sizes. For example, the cap 10 can be configured to attach to a Luer connector, such as a male or female Luer-Lok™ connector from Becton, Dickinson and Company. The cap 10 can also be configured to cover different connector designs, including but not limited to BD Q-Syte™, BD MaxZero™, BD MaxPlus™, and SmartSite™ needleless connectors from Becton, Dickinson and Company. The cap 10 can also be configured to connect to male or female connectors from other manufacturers, including but not limited to MicroClave® connectors (ICU Medical Inc.) and Ultrasite® connectors (B.Braun Medical Inc.). Sterilization caps for needleless connectors

[0080] Figures 2A to 6CAn exemplary disinfection cap 10 is illustrated that is configured to engage a needleless connector, such as the male connector 110 or the female connector 112 described previously. The cap 10 includes a multi-part housing that engages and cleans the surfaces of the connectors 110, 112, ensuring that the connectors 110, 112 remain sterile and ready for use. Specifically, the cap 10 includes an outer housing 12 and an inner housing 14 that retracts into the outer housing 12 as the cap 10 is secured to the needleless connectors 110, 112. The cap 10 also includes an absorbent member 16 disposed in the inner housing 14 that contacts the surfaces of the needleless connectors 110, 112 for cleaning and / or disinfecting the surfaces of the needleless connectors 110, 112.

[0081] As described in further detail herein, as the inner housing 14 is retracted into the outer housing 12, the inner housing 14 is configured to twist or rotate relative to the outer housing 12 and relative to the female connectors 110, 112 inserted into the inner housing 14. The twisting or rotation of the inner housing 14 relative to the connectors 110, 112 causes the absorbent member 16 to contact and rub against the surfaces of the connectors 110, 112 for mechanically removing (e.g., scrubbing) particles from the surfaces of the connectors 110, 112. In particular, the cap 10 of the present disclosure can be configured to sweep across the surfaces of the connectors 110, 112 or twist or rotate back and forth multiple times (e.g., at least four or more sweeps) on the surfaces of the connectors 110, 112 during the insertion of the inner housing 14 into the outer housing 12. The number of sweeps or back and forth rotations can be selected to meet the requirements for cleaning, disinfecting, and sterilizing the connectors 110, 112 employed by many medical institutions. Thus, use of the cap 10 disclosed herein facilitates the practitioner to clean the connectors 110 , 112 in a manner consistent with accepted or required cleaning and sterilization protocols.

[0082] like Figures 2A to 3C as well as Figures 5A to 6C, the outer housing 12 is a container, such as a cup-shaped member, that includes a first or top end 18, an open second or bottom end 20, and a sidewall 22 extending between the top end 18 and the bottom end 20. In some examples, the top end 18 of the outer housing 12 is a closed structure for retaining the inner housing 14, the absorbent member 16, and the cleaning solution contained by the absorbent member 16 within the outer housing 12. In some examples, the top end 18 can be open and covered by a separate and / or removable cap, cover, seal, or the like. The sidewall 22 of the outer housing 12 is generally cylindrical, having a cylindrical outer surface 24 and a cylindrical inner surface 26 that defines a cylindrical cavity sized to receive the inner housing 14. In some examples, portions of the exterior surface 24 and / or interior surface 26 of the outer housing 12 may also be beveled, angled, or tapered to make it easier to insert the inner housing 14 and / or connectors 110 , 112 into the outer housing 12 .

[0083] The outer housing 12 also includes one or more guide surfaces, members, or structures (referred to herein as outer guides 28) on the interior surface 26 of the sidewall 22. In some examples, the outer guides 28 can be rails, including, for example, slots, ridges, grooves, or similar protrusions or recessed structures, that define a path for the inner housing 14 to move through the outer housing 12 and / or relative to the rest of the cap 10 and the connectors 110, 112 connected thereto. As described in further detail herein, the outer guides 28 are configured or shaped to cause the inner housing 14 to twist, rotate, or sweep across the surfaces of the connectors 110, 112 multiple times to mechanically remove (e.g., scrub) particles from the connectors 110, 112.

[0084] The cap 10 also includes an inner housing 14 that is inserted into the outer housing 12. Specifically, the inner housing 14 is configured to be inserted from an initial or extended position ( Figure 2A and Figure 3A ) moves into the outer housing 12, wherein the bottom end 30 of the inner housing 14 extends beyond the bottom end 20 of the outer housing 12 to a final or retracted position (at Figure 2B and Figure 3C ), wherein the inner housing 14 is completely enclosed within the outer housing 12. Figures 2A to 4CAs shown in FIG, the inner housing 14 may include a first or top end 32 (which may be open, closed, or covered by a removable cap or cover); an open bottom end 30 sized to receive the distal end of the female needleless connector 112; and a sidewall 34 extending between the top end 32 and the bottom end 30. The inner housing 14 also includes an internal guide 36 located on an exterior surface 38 of the sidewall 34. The internal guide 36 is shaped and positioned to be received by the exterior guide 28 of the outer housing 12 for guiding movement of the inner housing 14 relative to the outer housing 12. For example, the internal guide 36 may be a protrusion, such as a pin, post, spike, elongated member, or the like, extending from the exterior surface 38 of the sidewall 34 of the inner housing 14. The internal guide 36 may be positioned to be received by and slide through the exterior guide 28, thereby guiding movement, and particularly rotation, of the inner housing 14 relative to the outer housing 12 and the connectors 110, 112 as the inner housing 14 is inserted into the outer housing 12.

[0085] In some examples, the inner guide 36 may be a pin or post integrally formed with and extending from the sidewall 34 of the inner housing 14. In other examples, such as Figure 4B and Figure 4C As shown in FIG, the inner guide 36 may be a threaded pin 62 including threads 64. The threaded pin 62 may be inserted into a corresponding cavity or recess in the sidewall 34 of the inner housing 14 for engaging the threaded pin 62 to the inner housing 14.

[0086] The inner housing 14 is configured to connect to the needleless connectors 110, 112 by inserting the distal ends of the needleless connectors 110, 112 through the open bottom end 30 of the inner housing 14. The inner housing 14 can form an interference and / or frictional engagement with the needleless connectors 110, 112, which secures the cap 10 to the needleless connectors 110, 112. Because the inner housing 14 of the cap 10 engages the connectors 110, 112 through a friction fit and does not directly engage the threads of the connectors 110, 112, the cap 10 can be used with connectors 110, 112 having a variety of thread patterns, sizes, and shapes.

[0087] Once the needleless connectors 110, 112 are inserted into the inner housing 14, the inner housing 14 moves through the outer housing 12, thereby securing the needleless connectors 110, 112 to the cap 10. As previously described, the guides (e.g., the outer guide 28 of the outer housing 12 and the inner guide 36 of the inner housing 14) are positioned to guide the movement of the inner housing 14 as the inner housing 14 is inserted into the outer housing 12. Specifically, as the inner housing 14 is inserted into the outer housing 12 (as indicated by the outer housing 12), the inner housing 14 moves through the outer housing 12, thereby securing the needleless connectors 110, 112 to the cap 10. Figure 3AThe inner guide 36 moves along the outer guide 28, which causes the inner housing 14 to move axially into the outer housing 12. The positioning of the guides 28, 36 also causes the inner housing 14 to rotate relative to the outer housing 12 and the connectors 110, 112 in a first or clockwise direction (as indicated by the arrow A2 in FIG. Figure 3B A2 in the figure) twists or rotates in a second or counterclockwise direction (as indicated by the arrow A2 in the figure) Figure 3B In order to provide a torsion or back and forth rotation, as shown by the arrow A3 in FIG. Figures 3A to 3C As best shown in FIG, the outer guide 28 or track includes portions or segments 40 that rotate the inner housing 14 in a clockwise direction alternating with other portions or segments 42 that rotate the inner housing 14 in a counterclockwise direction. Figures 3A to 3C As shown in FIG, the track or outer guide 28 includes four clockwise segments 40 and four counterclockwise segments 42, which means that as the inner housing 14 is moved from the extended position ( Figure 2A and Figure 3A shown) moves through the intermediate or in-use position ( Figure 3B shown) to the final or retracted position ( Figure 2B and Figure 3C As shown), the inner housing 14 alternates four times between rotating in a clockwise and counterclockwise direction.

[0088] The angular distance or angle of each successive rotation or sweep is determined based on the configuration of the guides 28, 36. For example, the guides 28, 36 may be configured to rotate the inner housing 14 in a clockwise direction (as determined by the angle of the guides 28, 36) during each clockwise rotation or sweep. Figure 3B In a similar manner, the inner housing 14 may be twisted or rotated in a counterclockwise direction (as indicated by arrow A2 in FIG. 1 ) to an angular distance of about 45 degrees to about 270 degrees. Figure 3B ) is rotated by an angular distance of about 45 degrees to about 270 degrees.

[0089] Twisting or rotating the inner housing 14 back and forth (e.g., clockwise and counterclockwise) relative to the outer housing 12 and the needleless connectors 110, 112 causes the absorbent member 16 to rub against the surfaces of the needleless connectors 110, 112, thereby mechanically removing (e.g., scrubbing) particles such as dust, dirt, debris, microorganisms, bacteria, cells, and any other contaminants from the surfaces of the needleless connectors 110, 112.

[0090] As previously discussed, the length and configuration of the outer guide 28 or track can be selected based on the protocol or requirements for sterilizing the hub or port using the sterilization cap 10. For example, the outer guide 28 or track can include enough segments 40, 42 to allow the cap 10 to be rotated or swept over the connectors 110, 112 the number of times required by the medical facility's sterilization protocol. Figures 3A to 3C , the outer guide 28 includes four clockwise segments 40 and four counterclockwise segments 42, which means that as the inner housing 14 is retracted into the outer housing 12, the cap 10 rotates or sweeps over the connectors 110, 112 eight times. In other examples, the outer guide 28 can be made with fewer or more segments 40, 42, depending on the requirements of a particular medical facility or sterilization protocol. In addition, the outer guide 28 or track can be long enough to ensure that the practitioner continues to scrub the female connector 112 for the length of time or duration required or recommended by the medical facility's sterilization protocol. For example, the outer guide 28 or track can be long enough to ensure that moving the inner housing 14 from the extended position to the retracted position takes at least 10 seconds, 20 seconds, 30 seconds, or more to comply with a particular sterilization protocol.

[0091] In addition to the segments 40, 42 that guide the rotation of the inner housing 14 in the clockwise and counterclockwise directions, the outer guide 28 may also include a longitudinal or vertical slot 44 or groove positioned for initially inserting the inner guide 36 into the outer guide 28 or track. For example, the vertical slot 44 may extend between the open bottom end 20 of the outer housing 12 and the distal or bottom end of one of the segments 40, 42 of the track, positioned to receive the inner guide 36 as the inner housing 14 is inserted into the outer housing 12.

[0092] In some examples, the housings 12, 14 may include a plurality of separate guide structures or guides 28, 36 for improving the stability of the inner housing 14. For example, Figure 2AAs best shown in the drawings, the outer housing 12 may include two separate guides 28 or tracks, each of which is positioned to receive a separate inner guide 36, such as a protrusion or pin, extending from the inner housing 14. Specifically, the inner housing 14 may include a first protrusion or pin configured to be received within the first guide 28 or track and a separate second protrusion or pin configured to be received within the second guide 28 or track on the side of the interior surface 26 of the sidewall 22 opposite the first guide 28 or track. In some examples, the first guide 28 or track may be symmetrical with the second guide 28 or track about the longitudinal axis of the outer housing 12. Including multiple tracks 28 and protrusions may increase the stability of the inner housing 14, ensuring that the inner housing 14 is smoothly moved into the outer housing 12 and rotated relative to the outer housing 14 for wiping the female connector 112.

[0093] Specific reference Figure 2A 、 Figure 2B and Figures 6A to 6C In some examples, the outer housing 12 further includes a protrusion 46, such as a blocking or interference protrusion, positioned to prevent the inner housing 14 from being removed from the outer housing 12 and provide visual feedback to the practitioner that the cap 10 has been used and should be discarded. In particular, the protrusion 46 can be configured to automatically move to an extended or blocking position when the inner housing 14 is inserted into the outer housing 12 to indicate to the practitioner that the cap 10 has been used.

[0094] like Figure 6A As most clearly shown in FIG, the outer housing 12 includes six generally triangular-shaped protrusions 46 positioned equidistantly around the circumference of the interior surface 26 of the sidewall 22 of the outer housing 12. However, the shape, number, and orientation of the protrusions 46 are not intended to limit the present disclosure. In some examples, the outer housing 12 may include fewer than six protrusions 46 or more than six protrusions 46. Furthermore, the protrusions 46 may be rectangular, square, trapezoidal, or any other convenient shape suitable for resisting removal of the inner housing 14 from the outer housing 12. Figures 6A to 6C As shown in FIG, the protrusion 46 can be positioned proximate the open bottom end 20 of the outer housing 12. The protrusion 46 can be pivotally connected to the interior surface 26 of the side wall 22 of the outer housing 12 and biased to pivot away from the interior surface 26 of the side wall 22 toward the blocking position. When the inner housing 14 is in the extended position, the protrusion 46 is pushed away from the open bottom end 20 of the outer housing 12. As the inner housing 14 is retracted into the outer housing 12, the protrusion 46 (in the form of a recessed portion) is retracted. Figure 6C direction indicated by arrow A4 in the middle) from a retracted or recessed position to an extended or blocking position (in the Figures 6A to 6C shown in ).

[0095] The inner housing 14 and the outer housing 12 can be formed of plastic materials commonly used for disposable medical devices and accessories. For example, the inner housing 14 and / or the outer housing 12 can be formed of a thermoplastic polymer material, such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene. In some examples, the inner housing 14 and / or the outer housing 12 can be formed of a durable material, such as a material having a Shore hardness "D" value of less than or equal to about 95. Alternatively, the inner housing 14 or the outer housing 12 can be formed of a more flexible material, such as a material having a Shore hardness "A" value of less than or equal to about 95. In particular, portions of the inner housing 14 can be made flexible enough to bend or deform so as to engage or connect with female needleless connectors 112 of different shapes, sizes, and configurations.

[0096] The outer housing 12 and / or the inner housing 14 may include or be formed from a single molded component, or may include or be formed from a plurality of molded components, such as molded components made by injection molding or other common plastic molding processes known in the art. If desired, the plurality of molded components may be assembled together to form the outer housing 12 and / or the inner housing 14 using common assembly processes known in the art (e.g., ultrasonic welding, laser welding, adhesives, etc.).

[0097] Reference again Figures 2A to 2C , the cap 10 further includes an absorbent member 16 disposed within the inner shell 14, such as Figure 2B . The absorbent member 16 can be a cylindrical or tubular structure having a circular top 48, a circular bottom 50, and a cylindrical outer surface 52 extending therebetween. The absorbent member 16 can be retained within the cylindrical cavity defined by the inner housing 14 by frictional engagement between the surface of the absorbent member 16 and the inner surface of the inner housing 14. Alternatively or additionally, the absorbent member 16 can be retained within the inner housing 14 by conventional fasteners or adhesives known in the art.

[0098] The absorbent member 16 is generally formed of a deformable material that is capable of compressing, bending, and deforming as the connectors 110, 112 are inserted into the inner housing 14. In particular, the absorbent member 16 can compress or deform to match the shape of the exterior surface of the needleless connectors 110, 112 inserted into the inner housing 14. Thus, the absorbent member 16 can be configured to contact numerous portions of the exterior surfaces of the connectors 110, 112 to scrub or mechanically remove particles, dirt, dust, microorganisms, and other debris from the surfaces of the connectors 110, 112. Furthermore, the absorbent member 16 can be formed of an abrasive and / or porous material that contacts the surfaces of the connectors 110, 112, providing enhanced scrubbing and particle removal from the surfaces of the connectors 110, 112 compared to softer, smoother, or less abrasive materials.

[0099] In some examples, absorbent member 16 includes or is formed of an absorbent material capable of absorbing a cleaning or disinfecting solution used to clean and / or disinfect the various portions of connectors 110, 112. Furthermore, absorbent member 16 can be configured to compress radially and / or axially as the distal portions of connectors 110, 112 are inserted into inner housing 14. The radial and / or axial compression of absorbent member 16 can cause the cleaning solution in absorbent member 16 to flow away from absorbent member 16 and contact threads and other surfaces of connectors 110, 112, thereby cleaning and disinfecting the various portions of connectors 110, 112.

[0100] In some examples, absorbent member 16 can include a thermoplastic elastomer, such as polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene). Absorbent member 16 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. In other examples, the foam material can be Plastazote® foam, which is an engineered polymer foam from Zotefoams PCL.

[0101] In some examples, the absorbent member 16 is provided with (e.g., pre-soaked with) a cleaning or disinfecting solution during manufacture of the cap 10. The cleaning or disinfecting solution can be an antimicrobial, 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 approximately 70% IPA. In other examples, the cleaning solution can be a combination of approximately 0.5% to approximately 3.5% chlorhexidine gluconate and approximately 70% IPA. The chlorhexidine composition can be beneficial because it has a slower evaporation rate than IPA and can therefore provide longer-lasting disinfecting activity after the cap 10 is removed from the connectors 110, 112 and before the VAD is connected to the hub, port, or valve.

[0102] In some examples, the cap 10 may also include a removable and / or disposable protective cover 54 (e.g., Figure 2A ). A protective cover 54 can be provided to protect elements and portions of the cap 10, such as the inner shell 14 and the absorbent member 16, during transport and storage to prevent contamination and to prevent evaporation of the cleaning or disinfecting solution prior to use. The protective cover 54 can include a sheet material, such as a polymer film, having an adhesive on a first side of the sheet material for removably attaching the protective cover 54 to the open bottom 30 of the inner shell 14. Alternatively, the protective cover 54 can be removably attached to the open bottom 30 of the inner shell 14 by heat sealing. The protective cover 54 can be formed of an air-impermeable or substantially air-impermeable material so that the cleaning or disinfecting solution on the absorbent member 16 does not evaporate or dry out. Thus, the protective cover 54 can extend the shelf life of the cap 10 and prevent microorganisms and other debris from accumulating in the cap 10 prior to use.

[0103] refer to Figure 7A and Figure 7B In some examples, the cap 10 may also be provided with various retaining or locking structures for preventing the elements of the cap 10 from moving together or being activated until the cap 10 is ready for use. For example, the cap 10 may include a removable clip 56 that is configured to be connected to the cap 10 to prevent the inner housing 14 from being inserted into the outer housing 12 at an accidental or inappropriate time. Figure 7A , when the inner housing 14 is in the extended position, the clamp 56 is connected to the exterior surface 38 of the inner housing 14. For example, the clamp 56 can be held in place by frictional engagement with the exterior surface 38 of the inner housing 14. The clamp 56 prevents the inner housing 14 from being inserted into the outer housing 12 until the clamp 56 is removed from the inner housing 14. In some examples, the clamp 56 can be a molded structure, such as a molded part formed from a thermoplastic polymer resin by injection molding or another plastic molding process. In some examples, the removable clamp 56 can include a C-clamp portion 58 and a handle portion 60 or grip extending from the C-clamp portion 58, the C-clamp portion 58 being configured to grasp and engage the exterior surface 38 of the inner housing 14. For example, as Figure 7A and Figure 7B As shown in , the handle 60 may be a circular section extending from the C-shaped clamp portion 58 that is configured to be grasped by a practitioner to remove the clamp 56 from the inner housing 14 . Method for attaching a connector to a cap

[0104] As previously described, the cap 10 of the present disclosure is a sterile cap 10 configured to connect to various types and sizes of needleless connectors 110, 112. For example, Figure 5A and Figure 5B The cap 10 is shown connected to a female Luer connector 112. Figure 5C and Figure 5D The cap 10 is shown connected to a male luer connector 110.

[0105] To connect the cap 10 to the male or female needleless connector 110, 112, the practitioner first removes any packaging from the cap 10 and removes the protective cover 54 (if present) from the bottom end 30 of the inner housing 14. The practitioner may also remove the clamp 56 (if present) so that the inner housing 14 can be freely moved into the outer housing 12.

[0106] Once the packaging, protective cover 52 and clamp 56 are removed, the cap 10 is ready for connection to the connectors 110, 112. Figure 3A In particular, as shown in the ready-to-use position Figure 3A , the cap 10 is shown in an initial or extended position, wherein the bottom end 30 of the inner housing 14 extends outside the outer housing 12. To attach the connectors 110, 112 to the cap 10, the practitioner first moves the cap 10 toward the connectors 110, 112, inserting the bottom end 30 of the inner housing 14 onto the connectors 110, 112. Specifically, for the female connector 112, the bottom end 30 is inserted over the opening 116 and septum 118 of the female connector 112. Continuing to move the female connector 112 into the housing 12 brings the outer surface 130 and corresponding threads 128 of the female connector 112 into contact with the circular top 48 and / or cylindrical outer surface 52 of the absorbent member 16. In a similar manner, for the male connector 110, the bottom end 30 is inserted over the stem 114. Continuing to move the male connector 110 into the housing 112 brings the outer surface of the stem 114 into contact with portions of the absorbent member 16.

[0107] Once the connectors 110, 112 are inserted into the inner housing 14, the practitioner applies axially directed pressure (e.g., Figure 3A 1 and A5 in the drawing, the inner housing 14 is retracted into the outer housing 12 and causes the threaded pin 62 of the inner housing 12 or the inner guide 36 to move through the vertical slot 44 or track of the outer guide 28 toward the segments 40, 42 of the outer guide 28. Continuing to move the inner housing 14 into the outer housing 12 causes the pin 62 or the inner guide 36 to move into the clockwise and counterclockwise segments 40, 42 of the outer guide 28 or track, as shown. Figure 3B As previously described, these sections 40, 42 allow the inner housing 14 to rotate in a clockwise direction (by Figure 3B in the direction indicated by arrow A2) and in the counterclockwise direction (indicated by Figure 3B Rotating inner housing 14 over connectors 110, 112 causes absorbent member 16 to press against and scrub the surfaces of connectors 110, 112, mechanically removing particles from the surfaces of connectors 110, 112. Furthermore, contact with connectors 110, 112 causes absorbent member 16 to compress, releasing a cleaning or disinfecting solution from absorbent member 16. The released cleaning solution cleans and disinfects the surfaces of connectors 110, 112. Furthermore, the cleaning or disinfecting solution can contact particles, such as biological material (e.g., microorganisms, cells, or bacteria), scrubbed from connectors 110, 112 to disrupt such biological material.

[0108] Continuing to press against the top end 18 of the outer housing 12 and / or continuing to press the connectors 110, 112 into the outer housing 12 causes the inner housing 14 to continue to rotate back and forth, scrubbing the surfaces of the connectors 110, 112 as the inner housing 14 is further retracted into the outer housing 12. Eventually, the inner guide 36 or protrusion travels to the proximal or top end of the outer guide 28 or track, which means that the inner housing 14 stops rotating and is fully seated or retracted within the outer housing 12. Figure 3C In the figure, the inner housing 14 is shown in the final or fully retracted position. As previously described, in the fully retracted position, the locking projection 46 automatically moves to the deployed position (as shown in FIG. Figure 2B and Figures 6A to 6C ), to prevent the inner housing 14 from being removed from the outer housing 12. At this point, the cap 10 is fully engaged to the connectors 110, 112 and can remain in place on the connectors 110, 112 for an extended period of time, such as up to seven days, which is the maximum usage time allowed by many medical institution protocols.

[0109] To remove the cap 10 from the connectors 110, 112, the practitioner grasps the cap 10 and / or the connectors 110, 112 and pulls the cap 10 away from the connectors 110, 112. As previously described, pulling the cap 10 away from the connectors 110, 112 causes the inner guide 36 to move through the sections 40, 42 of the outer guide 28, which means that the inner housing 14 rotates relative to the outer housing 12 and the connectors 110, 112. The inner housing 14 continues to move through the outer housing 12, eventually contacting the deployed locking tabs 46, which block further axial movement of the inner housing 14 relative to the outer housing 12 and prevent the inner housing 14 from being removed from the outer housing 12. With the inner housing 14 in contact with the locking tabs 46, the practitioner pulls the cap 10 away from the connectors 110, 112, which releases the cap 10 from the connectors 110, 112. Once the connectors 110, 112 are fully released or removed from the cap 10, the connectors 110, 112 can be connected to the VAD. For example, the connectors 110, 112 can be attached or inserted into a hub, port, or valve of the VAD, thereby forming a needle-free, fluid-tight connection between the connectors 110, 112 and the fluid pathway, channel, or lumen of the VAD. Method for manufacturing a disinfection cap having a multi-component housing

[0110] The cap 10 of the present disclosure is intended to be a single-use, disposable medical device that can be used to cover a medical connector (e.g., male luer connector 110 or female luer connector 112) during a single medical procedure or event. The cap 10 can be discarded after a single use. Therefore, the cap 10 is ideally inexpensive and easily manufactured using known commercial manufacturing processes (such as injection molding).

[0111] Figures 8A to 8C Aspects of the molding and assembly process for making the cap 10 of the present disclosure are shown. In particular, Figure 8A Shown are molds 210, 212 that may be used to form components 214, 216 of the outer shell 12. The molds 210, 212 may be three-piece molds that include a cavity 218, a core 220 including protrusions for forming the segments 40, 42 of the outer guide 28, and a side core 222 for forming the bottom end 20 of the outer shell 12. Figure 8B The components 214 , 216 of the outer housing 12 are shown prior to assembly. Figure 8C The outer housing 12 is shown as being made by assembling the components 214 , 216 .

[0112] The method of making the cap 10 includes a first step of making the outer shell 12. Specifically, the outer shell 12 can be made by forming a first part 214 and a second part 216 in molds 210, 212. For example, the parts 214, 216 can be made by a common plastic molding process (such as injection molding). After the parts 214, 216 are formed and removed from the molds 210, 212, the parts are assembled to form the outer shell 12. For example, the parts 214, 216 can be joined together at the weld joint 224 by ultrasonic welding (at Figure 8C shown in ).

[0113] The method also includes the step of forming inner housing 14. Unlike outer housing 12, inner housing 14 can be a single molded component formed, for example, through a single injection molding step. The method also includes forming absorbent member 16. For example, absorbent member 16 can be formed by cutting or stamping a foam component of the desired shape and size from a larger foam component or sheet. In other examples, absorbent member 16 can be formed through molding or extrusion processes known in the art.

[0114] After the outer shell 12, inner shell 14, and absorbent member 16 are fabricated, the method includes the final step of assembling the cap 10. For example, assembly may include inserting the absorbent member 16 into the inner shell 14. As previously described, the absorbent member 16 may be retained within the inner shell 14 by a friction fit and / or using various fasteners or adhesives. The method also includes partially inserting the inner shell 14 into the outer shell 12. To insert the inner shell 14 into the outer shell, the inner guide 36 is aligned with the vertical slot 44 of the outer shell 12. The inner shell 14 is then advanced axially into the outer shell 12 to an initial or extended position (at Figure 2A and Figure 3A Once the inner housing 14 is in the desired position, the clamp 56 can be removed (shown in Figure 7A and Figure 7B ) may be attached to the inner housing 14 to retain the inner housing 14 in an initial or extended position and prevent the inner housing 14 from being prematurely inserted further into the outer housing 12.

[0115] Although examples of the disinfection cap 10 and methods of use of the present invention are shown in the drawings and described in detail above, other examples will be apparent to those skilled in the art and can be readily made without departing from the scope and spirit of the present invention. Therefore, the foregoing description is intended to be illustrative and not limiting. The invention described above is defined by the appended claims, and all modifications of the invention that come within the meaning and equivalent range of the claims are intended to be included within their scope.

Claims

1. A disinfection cap for a needleless connector, the disinfection cap comprising: an outer housing comprising a first end, an open second end, a sidewall extending between the first end and the second end, and at least one outer guide on an interior surface of the sidewall; an inner housing comprising a first end, an open second end sized to receive a distal end of the needleless connector, a sidewall extending between the first end of the inner housing and the second end of the inner housing, and at least one inner guide on an exterior surface of the sidewall of the inner housing that interacts with at least one outer guide of the outer housing; and at least one absorbent member disposed within the inner housing, the absorbent member configured to contain a cleaning solution for cleaning and / or disinfecting a portion of the needleless connector that is engaged to the disinfection cap, wherein movement of the at least one inner guide relative to the at least one outer guide causes the inner housing to move axially into the outer housing and alternate between rotating in a first direction and in a second direction relative to the outer housing.

2. The disinfection cap according to claim 1, wherein: The inner housing is configured to move between an extended position in which the second end of the inner housing is external to the outer housing and a retracted position in which the inner housing is completely within the outer housing.

3. The disinfection cap according to claim 2, wherein: As the inner housing moves from the extended position to the retracted position, movement of the at least one inner guide relative to the at least one outer guide causes the inner housing to rotate back and forth a plurality of times as the inner housing advances to the retracted position.

4. The disinfection cap according to claim 3, wherein: The inner housing rotates back and forth at least four times as the inner housing moves from the extended position to the retracted position.

5. The disinfection cap according to claim 1, wherein: The needleless connector includes a male Luer connector or a female Luer connector.

6. The disinfection cap according to claim 1, wherein: The at least one outer guide comprises a track extending inwardly from an interior surface of a sidewall of the outer housing, and wherein the track comprises alternating segments for rotation in a first direction connected in series with segments for rotation in a second direction.

7. The disinfection cap according to claim 6, wherein: The track includes a groove or slot extending into the side wall of the outer housing.

8. The disinfection cap according to claim 6, wherein: The at least one inner guide includes a protrusion extending radially outward from an exterior surface of a sidewall of the inner housing, the protrusion being received within a track of the outer housing.

9. The disinfection cap according to claim 6, wherein: The track also includes a longitudinally extending groove or slot extending between the open second end of the outer housing and a distal end of one of the segments of the track, positioned to receive the at least one inner guide as the inner housing is inserted into the outer housing.

10. The disinfection cap according to claim 6, wherein: The section of the track extends non-helically around the interior surface of the outer housing for less than one complete turn.

11. The disinfection cap according to claim 6, wherein: Each alternating segment rotates the inner housing about the longitudinal axis of the inner housing by an angular distance of about 45 degrees to about 270 degrees.

12. The disinfection cap according to claim 1, wherein: Rotation of the inner housing about the needleless connector inserted into the inner housing causes the at least one absorbent member to scrub the needleless connector inserted into the inner housing.

13. The disinfection cap according to claim 1, wherein: The outer housing further includes at least one protrusion that is depressed into a recessed position when the inner housing is in the extended position, and that moves into a blocking position that prevents the inner housing from being removed from the outer housing when the inner housing is inserted into the outer housing and moves toward the retracted position.

14. The disinfection cap according to claim 13, wherein: The at least one projection is pivotally connected to an interior surface of a side wall of the outer housing and is biased to pivot away from the interior surface of the side wall to the blocking position.

15. The disinfection cap according to claim 13, wherein: When the inner housing is inserted into the outer housing, the at least one projection automatically moves from the recessed position to the blocking position.

16. The disinfection cap according to claim 1, wherein: The outer housing includes a plurality of protrusions that are biased to a recessed position when the inner housing is in the extended position and that move to a blocking position that prevents removal of the inner housing from the outer housing when the inner housing is inserted into the outer housing and moves toward the retracted position, and Wherein, the plurality of protrusions include a plurality of slender members having a first end connected to the side wall of the outer shell and a second end configured to protrude into the space defined by the side wall of the outer shell to block the inner shell from being removed from the outer shell.

17. The disinfection cap of claim 1, further comprising the cleaning solution absorbed by the at least one absorbent member, the cleaning solution comprising isopropyl alcohol (IPA) and / or chlorhexidine gluconate.

18. The disinfection cap of claim 1 , further comprising a removable clamp configured to connect to an exterior surface of the inner housing when the inner housing is in an extended position, which prevents the inner housing from being inserted into the outer housing until the clamp is removed from the exterior surface of the inner housing.

19. A method for manufacturing the disinfection cap according to claim 1, the method comprising: forming a first component of the outer housing in a first mold; forming a second part of the outer housing in a second mold; attaching the first component to the second component by ultrasonic welding to form the outer housing; forming the inner housing through a single molding process; inserting at least one absorbent member into the inner housing; and The inner housing is inserted into the formed outer housing.

20. A method of using the disinfection cap according to claim 1, comprising: inserting a distal end of the needleless connector into the open second end of the inner housing such that a surface of the at least one absorbent member contacts the distal end of the needleless connector; as well as The outer housing is pressed toward the needleless connector, causing the inner housing to rotate relative to the outer housing and the needleless connector for scrubbing a surface of the needleless connector.

Images