Disinfecting luer cap and method of use

Medical devices including a cap for a medical connector are disclosed. In some embodiments, the cap comprises a disinfectant, such as an antiseptic fluid and an insert configured to seal or partially seal the medical connector as it is engaged with the cap. In some embodiments the cap insert has a segment which is deformable under axially applied pressure as an end-user attaches the cap to the medical connector. In some embodiments this insert is configured to improve the exposure of antiseptic to the outer surface of the medical connector while minimizing exposure of the antiseptic inside the medical connector open lumen.

TECHNICAL FIELD

The field of the present disclosure relates generally to medical devices. More specifically, the present disclosure relates to caps for medical connectors. In some embodiments, the present disclosure relates to caps that can be used to protect the sterility of open medical connectors.

DETAILED DESCRIPTION

Patients undergoing various treatments may receive a central vascular catheter. Exposure of such catheters to foreign bodies increases the risk of catheter-related bloodstream infections. Infections associated with central venous catheters are categorized as either central-line associated bloodstream infections or catheter-related bloodstream infections. These infections can increase hospital costs and length of stay. The costs to hospitals and the health care system from these infections are substantial in terms of both morbidity and resources expended.

In the detailed description, reference is made to the accompanying drawings which form a part hereof and in which are shown, by way of illustration, specific embodiments of the disclosure. These embodiments are described in sufficient detail to enable those of ordinary skill in the art having the benefit of this disclosure to practice the present disclosure, and it is to be understood that other embodiments may be utilized, and that structural, logical, and electrical changes may be made within the scope of the disclosure. From the following descriptions, it should be understood that components of the embodiments as generally described and illustrated in the figures herein could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of various embodiments, as represented in the figures, is not intended to limit the scope of the disclosure, but is merely representative of various embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

In this description, specific implementations are shown and described only as examples and should not be construed as the only way to implement the present disclosure unless specified otherwise herein. It will be readily apparent to one of ordinary skill in the art having the benefit of this disclosure, for example, that the various embodiments of the present disclosure may be practiced with numerous types and forms of medical connectors. The devices and methods described herein could be useful in a number of environments that employ conduits or connectors, for example, the present disclosure may be practiced in any situation that uses at least one connector with a luer end.

The directional terms “proximal” and “distal” are used herein to refer to opposite locations on a medical device. The proximal end of the device is defined as the end of the device closest to the end-user when the device is in use by the end-user. The distal end is the end opposite the proximal end, along the longitudinal direction of the device, or the end furthest from the end-user.

Referring in general to the following description and accompanying drawings, various embodiments of the present disclosure are illustrated to show its structure and method of operation. Common elements of the illustrated embodiments may be designated with similar reference numerals. Accordingly, the relevant descriptions of such features apply equally to the features and related components among all the drawings. Any suitable combination of the features, and variations of the same, described with components illustrated inFIG.1, can be employed with the components ofFIG.2, and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereinafter. The figures presented are not meant to be illustrative of actual views of any particular portion of the actual structure or method, but are merely idealized representations employed to more clearly and fully depict the present disclosure defined by the claims below.

One embodiment of the present disclosure comprises a cap for a medical connector. The medical connector may have a luer connector. The cap may further comprise a disinfecting agent. In some embodiments the cap comprises a chamber containing the disinfecting agent. When an end-user attaches the cap comprising the disinfecting agent to the luer connector it applies the disinfectant to the open end of the luer connector. The open end of the cap is configured to connect to a medical connector such as a luer connector. In some embodiments the cap is configured to engage with a female luer connector, and in other embodiments the cap is configured to a male luer connector. For example, the cap may be configured with threads to engage a medical connector such as a male or female luer connector. In some embodiments these threads are configured with a hard stop to prevent an end-user from over rotating the cap. Additionally or alternatively, the threads may be configured to provide sufficient rotation of the cap with respect to a connector to dispense an adequate amount of antiseptic fluid to provide effective disinfection.

The cap may comprise a chamber which has a chamber inner lumen. Within the cap chamber the cap may further comprise a reservoir and an insert. The insert is disposed in the chamber lumen and comprises a first end which is shaped to engage with the open end of a medical connector such as a luer connector. This shape may be dome shaped, a frusto-conical shape, or any other shape which may seal or partially seal the open end of a medical connector to reduce fluid entering the lumen of the medical connector while maximizing the flow of fluid around the insert and the outer surfaces of the medical connector.

In some embodiments the cap is configured to facilitate alignment of the insert with the open end of a medical connector. For example, the insert may be disposed within the cap such that threads of the cap tend to align the insert and a medical connector during coupling of the cap and medical connector. The insert may thus tend to engage flush with the open end of a luer connector. In some embodiments the insert may engage substantially perpendicular to the open end of the luer so that the entire circumference of the open end of the luer connector engages substantially simultaneously with the insert. Engaging substantially simultaneously around the entire circumference of the open end of the luer connector may, in turn, reduce or minimize an antiseptic fluid from flowing into the inner luminal space of the luer connector when it engages with the cap.

The insert may also comprise an annular gap that allows an antiseptic fluid to flow around the insert and interact with the surface of the dome shaped first end of the insert during coupling of a cap and a medical connector. As the cap engages with the medical connector radial expansion of the insert may tend to reduce or eliminates this gap reducing or eliminating the amount of antiseptic fluid which can flow around the insert and interact with the medical connector.

Some caps within the scope of this disclosure may be configured to hold 45 pounds per square inch (PSI) of pressure.

The insert may further comprise a second end which is configured to deform when an end-user, such as a health care worker, engages the cap onto a medical connector. As the medical connector, such as the luer connector, is engaged with the cap the open end of the luer connector exerts axial force against the insert. In some embodiments, the insert second end deforms radially as the insert moves axially. The inner walls of the cap chamber may limit the degree the insert second end is able to deform under this axial force. In some embodiments, when the end-user disengages the cap from the luer connector, the insert second end begins to assume its original shape. In this way the insert may move like a spring axially within the cap chamber. When the insert springs back into its original shape it may thus maintain an axial force against the luer connector open end until the luer connector fully disengages from the cap. As the cap is disengaged in this manner the seal or partial seal is maintained between the insert first end and the open end of the luer connector, minimizing the amount of fluid that is able to enter the open end of the luer connector. This second end of the insert may be thought of as a controlled-deformation segment and serves to provide axial force against the medical connector which has been engaged with the cap. In some embodiments the insert second end may comprise external ribs that contact protrusions on the internal sidewall of the cap chamber. The cap is reusable, for example, configured with an insert that is able to deform and spring back into its original shape multiple times, or the cap may be configured as a single use device. The cap second end is further configured to be grasped comfortably and securely by an end-user, such as a health care worker.

In some embodiments the cap chamber further comprises a reservoir configured to absorb fluid, such as disinfectant antiseptic fluid. In some embodiments the reservoir is polyester urethane foam. In some embodiments the polyester urethane foam has a density of between 0.5 and 4 lbs/ft3. In some embodiments the polyester urethane foam has a density of between 1 and 3 lbs/ft3. In some embodiments the polyester urethane foam has a density of 2 lbs/ft3. In some embodiments the reservoir surrounds the insert. In alternative embodiments the reservoir is in a hollow portion of the insert. In some embodiments the reservoir is axially distal to the insert, in other words further from the open cap first end. In some embodiments the reservoir is axially proximal to the insert, in other words closer to the open cap first end. In some embodiments the reservoir is in contact with the insert first end. In some embodiments the reservoir is in contact with the insert second end.

Various materials are within the scope of this disclosure. For example, the insert may be comprised of various polymeric and/or elastomeric materials, including silicones, isoprene, neoprene, Santoprene, and so forth. The reservoir may comprise various foam materials, including polyester urethane foam as discussed above. The reservoir may also comprise an elastomeric material, including elastomers including pores or other structures capable of absorbing a liquid antiseptic agent. The reservoir may be a non-particulate elastomer configured to reduce or minimize breakdown of the reservoir that may result in particles within the cap or connector. Embodiments wherein the insert comprises a hollow portion or void with no separate component was a reservoir (such as embodiments wherein a void within an elastomeric insert is configured to act as a reservoir for an antiseptic fluid) are also within the scope of this disclosure.

The cap chamber may contain a disinfectant, such as an antiseptic. In some embodiments this antiseptic may be an antiseptic fluid such as isopropyl alcohol, hydrogen peroxide, chlorhexidine gluconate, iodophor, povidone iodine, or any other suitable antiseptic. In some embodiments the antiseptic is not fluid but in the form of disinfectant beads, such as hydrogel beads, disinfectant foam, or a loaded polymer. In some embodiments the antiseptic is sequestered in the cap chamber within a first closed compartment by a breakable seal, such as a foil seal. This foil seal will stay intact until an end-user engages the cap with a medical connector which then may exert axial pressure on the cap insert. Alternatively, a foil seal may be disposed across the cap chamber such that an end-user can peel off or otherwise remove the foil seal prior to use. The cap insert may then deform, exerting radial force which can then break the seal holding the antiseptic, releasing it into the cap chamber. In this way, the antiseptic is released and surrounds the insert and the outer surfaces of the medical connector while minimizing the amount of antiseptic that enters the luer connector open end which is loosely sealed by the cap insert first end. In some embodiments the antiseptic is soaked into the reservoir, and when the cap insert is pushed axially it compresses the reservoir, releasing the antiseptic into the chamber and similarly surrounding the insert and the outer surfaces of the medical connector. In some embodiments the antiseptic fluid is both in an absorbent reservoir and sequestered in a breakable seal within the cap chamber inner lumen.

In some embodiments when the end-user disengages the cap from the medical connector, the insert returns to its original shape, which increases the volume within the cap chamber. As the insert returns to its original shape the reservoir will expand, increasing the volume of fluid, such as antiseptic fluid, the reservoir can hold. As the reservoir expands it creates a vacuum or partial vacuum acting on the fluid, thus tending to draw in and absorb the fluid which had been surrounding the insert and the outer surfaces of the medical connector. In this way as the cap is disengaged from the medical connector the amount of fluid in contact with the outer surface of the medical connector decreases, which serves to further reduce the amount of fluid that enters the open end of the medical connector as it is fully disengaged from the cap and the insert first end.

In some embodiments the cap insert may be configured to store the antiseptic within the insert. For example, the insert may be hollow with side apertures to permit the antiseptic agent to flow out of the insert when axial force is exerted on the insert from the end-user attaching a medical connector to the cap. In some embodiments the insert first end may inhibit flow of fluid, such as an antiseptic fluid into the lumen of an engaged medical connector while allowing flow to specific regions on or in the medical connector. In some embodiments the insert is made of a single material. In alternative embodiments the insert first end is made of material different from the insert second end. In some embodiments the insert first end is reinforced to reduce deformation when axial force is applied to the insert when an end-user attaches a medical connector to the cap. In some embodiments the cap is configured with radial protrusions to maintain the insert in the cap chamber.

In some embodiments the method of capping a medical connector with a cap, as described above, is disclosed herein. The end-user may obtain a cap, as described above. If a foil seal is present, the end-user may peels off a foil seal from an end of the cap to open the cap chamber. The end-user may then connect the cap to the open end of the medical connect and twist either the cap to fully engage the cap on the connector or the connector to fully engage the cap. The cap will then disinfect, as described above, the outer surface of the medical connector while minimizing the amount of disinfectant that enters the open end of the medical connector. In some embodiments the cap may be configured with threading to engage the medical connector. In some embodiments these threads, or an end of these threads, are configured with a hard stop to prevent the end-user from over rotating the cap on the medical connector. In some embodiments the cap is configured to engage with a female luer connector. In alternative embodiments the cap is configured to engage with a male luer connector. In some embodiments the end of the cap is sealed with a sterile seal which is removable by the end-user just before it is attached to the medical connector.

In some embodiments the means for minimizing medical connector infections is provided by applying a cap, as described above, to a medical connector. The cap applies an antiseptic agent to a medical connector. In some embodiments, the cap has engagement means to attach to a male luer connector. In some embodiments, the cap comprises the means for limiting or minimizing the flow of antiseptic in the cap chamber as the end-user engages the open end of a medical connector with the cap, while at the same time maximizing the flow of antiseptic to the outer surface of the medical connector. In some embodiments the cap comprises an insert in the chamber, the insert comprising the means to exert axial force against the open end of the medical connector as the cap is both engaged and disengaged with the medical connector. In some embodiments the cap is configured with a means of maintaining the insert in the cap chamber.

FIG.1depicts a simplified exploded view of various components of a medical connector cap100. The cap100has a cap first end116which comprises an opening114and a second end122configured to be grasped securely and comfortably by an end-user. A cap body120is between the cap first end116and the second end122. In the illustrated embodiment, the cap first end116is configured to be attached to a male luer connector and further comprises ridges118which serve as threads to engage the male luer connector. The cap100comprises an insert102and a reservoir112. The insert102comprises an insert first end104configured to engage and seal or partially seal the open end of a male luer connector. In some embodiments, the insert first end104of the insert102may comprise a shape configured to seal or partially seal against a portion of a connector, such as a luer connector. For example, in the illustrated embodiment, the insert first end104of the insert102comprises a dome or curved shape, configured to seal or partially seal against a luer connector. As also described above, other shapes, such as frusto-conical shapes, are within the scope of this disclosure. Further, the insert first end104of the insert102may be configured to partially conform to the shape of a portion of the luer to facilitate sealing. In some embodiments the insert102is disposed within the cap100such that the ridges118, in threaded engagement with the luer, tend to align the cap100and the luer before the insert first end104engages the luer. Thus, the cap100may be configured such that the insert first end104is substantially perpendicular to the open end of the luer (not depicted) during coupling of the cap100and a luer. In some embodiments insert reinforcements106are configured to align or maintain the alignment of the insert first end104within (and with respect to) the cap100.

The insert102also comprises an insert body108between the insert first end104and an insert second end110. In this embodiment the insert second end110is configured to deform under axially applied pressure. In this embodiment the insert first end104is reinforced with the insert reinforcement106to reduce deformation of the insert first end104and the insert body108under axially applied pressure. In the depicted embodiment, the reservoir112comprises a reservoir hole113through which the insert second end110and the insert body108may be pushed. The insert first end104further serves to limit the distance the insert102can be pushed through the reservoir hole113. The insert reinforcement106may in some embodiments be configured to further limit the position the insert102takes within the reservoir112.

FIG.2Adepicts an end view of another embodiment of a cap200that resembles the cap100described above in certain respects. Accordingly, like features are designated with like reference numerals, with the leading digits incremented to “2.” For example, the embodiment depicted inFIGS.2A-2Bincludes a cap body220that may, in some respects, resemble the cap body120ofFIG.1. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the cap200and related components shown inFIGS.2A-2Bmay not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the cap200and related components depicted inFIGS.2A-2B. Any suitable combination of the features, and variations of the same, described with respect to the cap100and related components illustrated inFIG.1can be employed with the cap200and related components ofFIGS.2A-2B, and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereafter, wherein the leading digits may be further incremented.

The cap200comprises the cap body220and a cap first end216. The cap first end216comprises a cap opening214. The cap first end216is further configured to engage a male luer connector with threads218. An insert first end204is visible through the cap opening214.FIG.2Aalso indicates plane A-A through which a cross-section of the cap200is taken and shown inFIG.2B.

As noted above,FIG.2Bdepicts a cross-section view of the cap200through plane A-A ofFIG.2A. With reference toFIGS.2A-2B, the cap200illustrated therein comprises the cap first end216, the cap body220, and a cap second end222. The cap first end216comprises protrusions218which serve as threading to engage with a male luer connector. The cap first end216further comprises the cap opening214. The cap200also comprises a cap chamber224. In the illustrated embodiment, the cap chamber224comprises an inner lumen which contains an insert202and a reservoir212. The insert202comprises the insert first end204configured to engage with the open end of a medical connector. The insert202further comprises an insert body208and an insert second end210. The insert body208comprises an insert reinforcement206to reduce deformation of the insert202under axially applied pressure. The insert second end210is configured to deform under axially applied pressure. In this embodiment the insert second end210comprises two prongs which will bow outward radially until they come into contact with the cap chamber's224inner walls.

FIGS.3A and3Bdepict two examples of medical connectors.FIG.3Adepicts a perspective view of a medical connector hub330. The hub330has both a male luer connector338and two female luer connectors332. The female luer connector332comprises a first end336and an opening334. The male luer connector338comprises a threaded engagement member342, a male luer connector body340, and a male luer connector first end344. The male luer connector first end344comprises a male luer opening346.FIG.3Bdepicts a medical connector350which comprises a female luer connector352with a first end356. The female luer connector352first end356comprises a first opening354.

FIGS.4A and4Bdepict cross-section views of a cap400engaging a male luer connector end438, in first and second configurations, respectively. The medical connector such as the male luer connector end438is inserted so that a male luer connector body440is inserted into a cap opening414. The end-user will slide the male luer connector body440into the cap opening414until a male luer open end444comes into contact with an insert first end404. A male luer threaded engagement member442slides around a cap first end416to begin to engage with cap protrusions418which serve as threading. An insert reinforcement406and insert body408as well as a cap body420and cap second end422are also indicated in the figures.

In the first configuration, shown inFIG.4A, the end-user has not yet exerted enough axial force on an insert402to push it axially into a cap chamber424enough to deform an insert second end410. In the second configuration, shown inFIG.4B, the end-user has exerted enough axial force on the insert402to deform the insert second end410. The male luer threaded engagement member442is thus in position to engage the threading via the cap protrusions418and further tighten the cap400onto the male luer connector end438which will exert additional axial force on the insert402. As the insert402is forced down into the cap chamber424the insert second end410deforms, which may result in the decrease of the cap chamber424available volume and the compression of a reservoir412. An antiseptic (not depicted) may then be forced out of the reservoir412(for example due to the decrease in the volume of the reservoir412) into this remaining cap chamber424volume and would be exposed to the outer surface of the male luer open end444and the male luer connector body440. As the male luer connector end438is further tightened onto the cap400it may be configured to limit the amount of antiseptic which spills outside of the cap opening414. In other words, the reservoir412may act like a sponge, absorbing antiseptic liquid when the reservoir412is uncompressed and releasing antiseptic liquid into the cap chamber424as the reservoir412is compressed. Backing the cap400off the luer may allow the reservoir to return to an uncompressed configuration and reabsorb liquid antiseptic disposed in the cap chamber424.

FIG.5depicts a side view of a cap insert502. The insert502comprises an insert first end504configured and shaped to engage and seal or partially seal a medical connector open end. The insert502further comprises a reinforcement506configured to reduce deformation of the insert502near the insert first end504. An insert second end510is configured to deform under axially applied pressure. The insert502ofFIG.5is shown in a generally uncompressed configuration.

FIG.6depicts a side view of a cap insert602shown after axially applied pressure has deformed an insert second end610. In other words, as compared to the uncompressed configuration of the insert502ofFIG.5,FIG.6illustrates an analogous insert602in a compressed configuration. An insert first end604remains in its original shape and thus resists angular misalignment of the insert first end604. The insert first end604is reinforced with an insert reinforcement606. In other embodiments the insert first end604resists deforming under axially applied pressure while the insert second end610deforms because the insert first end604is made up of more rigid material than the insert second end610.

FIG.7depicts a perspective view of one embodiment of a reservoir712. This embodiment of the reservoir712is a cube, and the reservoir712comprises an opening713through which an insert, such as the insert502, may be placed.

FIG.8Adepicts a simplified exploded view of various components of a medical connector cap800. The cap800has a cap first end816which comprises a cap opening814and a cap second end822configured to be grasped by an end-user. A cap body820is between the cap first end816and the cap second end822. In the illustrated embodiment, the cap first end816is configured to be attached to a female luer connector and further comprises ridges818which serve as threads to engage the female luer connector. The cap800comprises an insert802and a reservoir812. The insert802comprises an insert first end804configured to engage and seal or partially seal the open end of a female luer connector (not depicted).

The insert first end804of the insert802may be dome shaped, with a hemispherical shape to engage and seal or partially seal the open end of a female luer connector (not depicted). Additionally or alternatively, the insert first end804of the insert802may be configured to partially conform to the shape of a portion of the luer to facilitate sealing. In some embodiments the insert802is disposed within the cap800such that the ridges818, in threaded engagement with a luer, tend to align the insert802and the luer before the insert first end804of the insert802engages the open end of the luer. Additionally, in some embodiments the insert802comprises an insert second end810which is open and configured to accept a reservoir such as the reservoir812within the insert802.

In some embodiments, the cap800is configured such that there is an annular gap805between the insert802and the cap800when the insert802is unconstrained. This annular gap805may allow an antiseptic fluid to flow around the insert802, for example, from the reservoir812adjacent the insert second end810of the insert802. Thus, the annular gap805may allow antiseptic fluid from the reservoir812to interact with the insert first end804and then come into contact with the luer end (not depicted) during coupling of a luer and the cap800. In some embodiments when the luer cap is partially or fully engaged with the cap800a compressive force exerted on the insert802by the luer may cause the insert802to radially expand, thus reducing or closing the annular gap805. This, in turn, may reduce or eliminate the antiseptic fluid flow around the insert802, which may limit excess antiseptic fluid from entering the luer end.

FIG.8Bdepicts a side view of the cap800. The cap800comprises the cap body820and the cap first end816. The cap first end816comprises an opening (not depicted). The cap first end816may be configured to engage a luer or other medical connector. The cap second end822may be configured to be grasped by an end-user. Line8C ofFIG.8Bindicates the plane of the cross-section depicted inFIG.8C.

FIG.8Cdepicts a cross-section of the cap800. The cap body820and cap first end816and indicated in this figure. In the illustrated embodiment, the cap first end816comprises the cap opening814. Further, the ridges818within the cap opening814may be configured as threads for engagement with a luer connector (not depicted).

As shown inFIG.8C, the cap800may also comprise the cap chamber824. The cap chamber824defines an inner lumen which contains the insert802and the reservoir812. Again, the first end804of the insert802is positioned and configured to engage with the open end of a medical connector such as a luer when the cap800is coupled to a medical connector. The insert second end810of the insert802may be configured to accommodate the reservoir812inside, or partially inside, the insert802. As noted above, the insert802and cap800may define the annular gap805. In some embodiments an antiseptic fluid (not depicted) is disposed within the cap chamber824. The reservoir812may absorb some or all of the antiseptic fluid.

FIGS.9A-9Cdepict a female luer connector932being connected to a cap body920.FIG.9Adepicts a cross-section of the luer connector932with a female luer connector first end936comprising an opening934.FIG.9Bdepicts the cap body920engaging with the luer connector932. A first cap end916of the cap body920comprises an opening914into which the luer connector932can be engaged. Ridges918disposed within the opening914are configured as threads to engage the female luer connector first end936. In the illustrated embodiment, an insert902has a dome shaped first end904which is configured to engage with the female luer connector first end936. An annular gap905is disposed between the insert902and the cap body920. The insert902may also partially receive and/or surround a reservoir912. As further detailed in Example 1, below,FIGS.9A-9Balso depict the deposition of a tungsten powder970on an inner luminal surface935of the female luer connector first end936and around the circumference of the opening934.

FIG.9Cdepicts a cross-section of the female luer connector first end936after it has been disengaged from a cap900, according to the procedure outlined in Example 1. As compared to the connector as depicted inFIGS.9A-9B, the tungsten powder970generally remains on the inner luminal surface935after disengagement of the female luer connector first end936from the cap900. As illustrated inFIG.9C, in some instances the tungsten powder970may be displaced by the first end904of the insert902when coupled as shown inFIG.9B. As explained in Example 1, the position of the tungsten powder970inFIG.9Cillustrates how the insert902and reservoir912may limit ingress of antiseptic fluid into the female luer connector first end936.

Kits that include a medical connector cap are also within the scope of this disclosure. For example, a kit may include any of the devices described above. The kit may also include other elements, such as instructions for using the devices. Kits may additionally or alternatively include (1) male luer connector caps; (2) female luer connector caps; (3) double-ended luer connector caps; (4) sterile gloves; (5) sterile barrier; (6) antiseptic swabs; and (7) sterile gauze, among other potential elements.

Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method.

Similarly, it should be appreciated by one of skill in the art with the benefit of this disclosure that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim requires more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. Thus, the claims following this Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims.

Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the present disclosure.

While the disclosure is susceptible to various modifications and implementation in alternative forms, specific embodiments have been shown by way of non-limiting example in the drawings and have been described in detail herein. However, it should be understood that the disclosure is not intended to be limited to the particular forms disclosed. Rather, the disclosure includes all modifications, equivalents, and alternatives falling within the scope of the disclosure as defined by the following appended claims and their legal equivalents.

Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the present disclosure to its fullest extent. The examples and embodiments disclosed herein are to be construed as merely illustrative and exemplary and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having skill in the art, and having the benefit of this disclosure, that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure herein.

Disinfecting caps for open female connectors were tested with stopcock connectors to observe alcohol ingress into the lumen of the stopcock connector. Testing did not show alcohol ingress but reflected evidence of the insert protruding for up to 1 mm into the lumen of the connector. As discussed above,FIGS.9A-9Cschematically illustrate the components of this Example. Three luer connector/cap assemblies were tested. For this example, the inserts902were made from Santoprene 8281-55MED. The reservoir912was composed of polyester urethane foam measuring 0.2 inches in diameter and having a height of 0.3 inches. 175 μl of 70% isopropyl alcohol was dispensed into the cap900, and the insert902/reservoir912assembly was inserted into the cap900. The resulting assembly was analogous to the assembly of the embodiment shown inFIG.8C.

A layer of the tungsten powder970was dusted into the inner luminal surface935of the luer connector932to act as the contrast agent, as the tungsten powder970would get disrupted when it encountered alcohol during testing of coupling and uncoupling of the luer connector932and the cap900.

Luer connectors932dusted with a tungsten powder970(in the configuration shown inFIG.9A) were mounted onto a luer post and placed in a 3D CT scanner for imaging. The luer connectors932were then assembled with the caps900as shown inFIG.9Band exposed to x-rays which was then followed by disassembly and a last round of imaging.

The caps900were found to maintain contact with the opening934of the luer connector932as the insert902in the cap900deformed to maintain pressure at the insert902—the opening934interface. This seal prevented alcohol from contact with the inner luminal surface935of the luer connector932. Tungsten particles were observed to be displaced (as shown inFIG.9C) around the circumference of the opening934. This displacement can be attributed to the physical disturbance caused by the insert902that protruding into luer connector932to prevent alcohol ingress.