Disinfecting caps having an extendable feature and related systems and methods

Some assemblies can include a male cap and a female cap, each of which can be used to cover separated medical connectors. In certain arrangements, a male cap can include a movable carriage that transitions from a retracted position when an assembly with which the male cap is associated is in a closed state to an extended position when the assembly is in an open state.

BACKGROUND

1. Technical Field

The present disclosure generally relates to caps for medical connectors and more specifically relates to caps that can be used to protect the cleanliness of unconnected medical connectors, such as connectors that may be used for fluid flow or for fluid delivery systems. Some embodiments are directed to caps for medical connectors that include elongated male portions.

2. Related Art

Bloodstream infections, such as may be caused by microorganisms that enter patients via intravascular catheters, are a significant cause of illness and excess medical costs. A substantial number of such infections occur in U.S. intensive care units annually. Additionally, a significant fraction of these infections result in death.

Guidelines from the Centers for Disease Control and Prevention describe various ways to limit bloodstream infections in hospital, outpatient, and home care settings. The guidelines address issues such as hand hygiene, catheter site care, and admixture preparation. However, despite these guidelines, such infections continue to plague healthcare systems at relatively unchanged rates.

Impregnating catheters with various antimicrobial agents is one approach for reducing these infections. Impregnated catheters, however, provide less than satisfactory results. Additionally, some microbes have developed resistance to the various antimicrobial agents used in the catheters. Other systems and approaches have also been developed, but these likewise suffer from a variety of limitations and drawbacks.

DETAILED DESCRIPTION

Disclosed herein are caps that can be used to protect and/or disinfect medical connectors. Systems and methods related to such caps are also disclosed. The caps, systems, and methods can reduce the threat of microorganisms entering the bloodstream of a patient via fluid flow or fluid delivery systems, such as, for example, needleless injection sites and/or fluid transfer devices having an elongated male portion or male protrusion, such as, for example, a male luer. In some embodiments, a cap is configured to couple with and disinfect a medical connector having a male protrusion. In further embodiments, the cap can include an antiseptic, and can be configured to create a seal with the male protrusion so as prevent antiseptic from entering a lumen of the male protrusion. In some embodiments, the antiseptic may be contained within a pad prior to the coupling of the cap to the medical connector, and the act of coupling the cap to the medical connector can force at least a portion of the antiseptic from the pad and into contact with the male protrusion. In still further embodiments, the male cap can be coupled with a female cap to form an assembly. The male cap can include a translatable portion that is retained in a retracted position when the assembly is in a pre-use state. Separation of the male and female caps can result in translation of the translatable portion to an extended position that is more readily accessible by a medical connector.

By way of background,FIG. 21illustrates an example of medical connectors300,360for which caps disclosed herein may be used. Any suitable variety of medical connectors300,360is possible, such as, for example, luer lock connectors. The connectors300,360are associated with a fluid pathway1200, such as a fluid line1205of any suitable variety, which may be coupled with an IV bag1210or other suitable fluid delivery system. Commonly, the fluid pathway1200can be used to intermittently administer medications to a patient P.

In the illustrated embodiment, the connector360of the fluid pathway1200, which communicates fluids with a patient's blood stream, may be selectively disconnected from the connector300. One or more of the connectors300,360may be connected to other connectors (not shown), such as a connector associated with a central line. The medical connectors300,360may be connected and disconnected at various times, and may remain disconnected for several minutes or hours. Medical connector caps disclosed herein can be used to cover and protect the various medical connectors300,360while the connectors are separated from one another.

Upon separation of the medical connectors300,360from each other, each separated connector can benefit from being covered by a cap. Therefore, in some cases, it can be advantageous to have a single connector set or assembly that includes both a male cap and a female cap that can be used to provide protection for both ends of a separated connection. In other or further embodiments, a cap can include an antiseptic for disinfecting a medical connector. In some cases, it can be advantageous for the cap to form a seal with a portion of the medical connector to thereby prevent the antiseptic from exiting the cap into the fluid pathway. In some embodiments, a male cap includes a translatable portion that is retained in a retracted position when the cap assembly is in a pre-use state. Separation of the male and female caps can result in translation of the translatable portion to an extended position that is more readily accessible by a medical connector.

FIGS. 1-3illustrate an embodiment of a set or assembly100that includes an embodiment of a female cap102and an embodiment of a male cap104, each of which can be used to cover a separated connector360,300, respectively. The assembly100can be provided in a pre-use, assembled, or closed state in which the female and male caps102,104are coupled with each other, as shown inFIG. 1. As further discussed below, when the caps102,104are coupled with each other, they may form a fluid-tight seal, which can prevent antiseptic from evaporating from an interior of the assembly100to an exterior thereof. In particular, the female and male caps102,104can be coupled with each other via a sealing mechanism189. In the illustrated embodiment, the sealing mechanism189comprises a sealing sleeve191, which is fixedly connected to (e.g., integrally formed with) the male cap104. The terms “coupled” and variants thereof are used in their ordinary sense and include arrangements such as that illustrated inFIG. 1, in which the caps102,104directly engage one another when the assembly100is in the assembled or pre-use state.

As shown inFIG. 2, the female and male caps102,104can be separated from each other. It may be said that the assembly100is in an open or operational state when it is in such an arrangement. In the illustrated embodiment, all components of the assembly100are contained in or otherwise embodied by one of the female and male caps102,104. Accordingly, in some embodiments, the assembly100can be devoid of pieces or parts that are readily separable from either of the female and male caps102,104during or after a transition of the assembly100from the closed to the open state. Accordingly, the female and male caps102,104each can comprise separate, self-contained, or individual assemblies that may be directly joined to each other, thereby resulting in the composite assembly100it its closed state (shown inFIG. 1), and that may be separated from each other, thereby resulting in the disassembled assembly100in its open state (shown inFIG. 2). A lack of separate, additional parts when the female and male caps102,104are disconnected from each other can have a variety of advantages. For example, such arrangements can, among other things, provide for a less cluttered work space or environment when one or more of the caps102,104are in use.

As shown inFIG. 2, and as discussed further below, in certain embodiments, the male cap104can include an outer housing150, which can receive a translating or telescoping member, shuttle, or carriage200. The carriage200can be configured to transition between a retracted (e.g., distal) position and an extended (e.g., proximal) position. InFIG. 2, the carriage200is in the extended position, whereas it is in the retracted position inFIG. 9, as discussed further below. The male cap104can include a biasing member202, which can be configured to urge or bias the carriage104proximally toward the extended position.

The terms “proximal” and “distal,” when used herein relative to a cap, or components thereof, are used relative to the coupling of the cap with a medical device, such that the medical device is inserted into a proximal end of the cap, or component thereof and advanced toward a distal end of the cap or component. Accordingly, in the illustrated embodiment, the proximal ends of the caps102,104are directed toward each other and the distal ends of the caps102,104are directed away from each other when the assembly100is in the pre-use configuration (seeFIG. 1).

FIG. 3is an exploded view of the assembly100. The female cap102can include a housing110into which an antiseptic reservoir or pad132is received. As previously mentioned, the male cap104can include a carriage200, which can be configured to receive a resilient support177, an antiseptic reservoir or pad170, and a sealing member190. As further discussed below, the resilient support177and the pad170may be considered as a multi-part biasing member176that is configured to urge the sealing member190toward a proximal end of the carriage200.

As previously mentioned, the housing150of the cap104can be configured to receive the biasing member202and the carriage200. In the illustrated embodiment, the carriage200comprises a movable, translatable, or inner housing210, and the biasing member202comprises a coil spring212. As further discussed below, the coil spring212can be configured to urge the inner housing210in the proximal direction, or toward a proximal end of the shell or outer housing150.

With reference toFIGS. 4A-4Cand9, the housing110of the female cap102can extend between a closed distal end and an open proximal end. The closed distal end does not permit any fluid flow therethrough and serves as a barrier between an interior of the housing110and an exterior environment. The open proximal end of the housing110is configured to receive at least a portion of a medical connector therein, as further discussed below with respect toFIGS. 12-14. The housing110can include a sidewall112, which defines the open proximal end, and a base wall113, which defines at least a portion of the closed distal end.

The housing110can include a body region136near a proximal end thereof, which is substantially cylindrically shaped in the illustrated embodiment. A handle137can extend from the body region136so as to be positioned at the distal end of the cap102. The handle137can comprise any suitable gripping features103, which, in the illustrated embodiment, comprise opposing gripping regions or grasping platforms138that are configured to provide a convenient surface against which a user can press so as to hold and/or twist the cap102.

As shown inFIG. 4B, the illustrated grasping platforms138are mirrored about a longitudinal plane LP that extends along a central longitudinal axis A (shown inFIG. 4A) of the housing110. Each grasping platform138angles radially inwardly from the body region136toward the longitudinal plane LP, in a proximal-to-distal direction. The grasping platforms138are more steeply angled at their proximal ends than they are at their distal ends. The angled platforms138, and particularly the steeply angled portions thereof, provide convenient surfaces to which forces may be applied in a distal-to-proximal direction. In the illustrated embodiment, the platforms138define two substantially planar regions that are smoothly joined to each other at a rounded transition. The platforms138can define a contour that is substantially complementary to fingertips that are pointed in the proximal direction.

As shown inFIG. 4A, the illustrated grasping platforms138also taper inwardly toward the central longitudinal axis A of the housing110in a proximal-to-distal direction. In the elevation view that is shown, the platforms138are substantially ovoid. The platforms138are sized and shaped to be held between the fingertips of a thumb and another finger (e.g., the index finger) of a user, although other grasping configurations may also be efficiently employed with the illustrated arrangement. The platforms138provide convenient surfaces to which torque may be applied so as to rotate the cap102about the longitudinal axis A.

With reference toFIGS. 4A-4C, the cap102can include a lip, rim, or flange115that extends radially inwardly at a proximal end of the body region136. The flange115can define one or more recesses116, which can be complementary to features of the male cap104so as to define at least a portion of a separation assisting cam, as discussed further below. The flange115also can contact an edge of the sleeve191portion of the male cap104to ensure the desired insertion depth of the cap102within the sleeve191.

With reference again toFIG. 4B, each recess116can be at least partially defined by a pair of faces116a,116bof the flange115that are angled in opposite directions. The angles can be any suitable non-zero, non-180-degree angles relative to a transverse cross-sectional plane TP that passes perpendicularly through the a central axis A of the housing110. In particular, the faces116acan define an angle α relative to the transverse plane TP, and the faces116bcan define an angle β relative to the transverse plane TP. In the illustrated embodiment, the angles α, β are the same, although other arrangements are possible (as discussed further below). For a path is traced along the flange115in a clockwise direction (when looking toward the flange115), the path moves proximally along the faces116aand the path moves distally along the faces116b. The faces116a,116bcan be substantially planar over at least a portion thereof, and can be configured to complementarily contact faces of the sleeve191. Additional discussion of the faces116a,116bis provided below with respect toFIGS. 10A-10B.

The housing110defines an external surface118and an internal surface119, each of which extends away from the flange115. The internal surface119of the cap102can include an outwardly directed surface of the sidewall112, a proximal end124of the sidewall112, and an inwardly directed surface of the sidewall112(seeFIGS. 4C and 9). The outwardly directed portion of the internal surface119can define a connection interface140that is configured to interact with or engage a connection interface195of the sleeve191(seeFIG. 5C) so as to connect the cap102to the sleeve191. In the illustrated embodiment, the connection interfaces140,195couple with each other via a friction-fit engagement. For example, an inner diameter of the connection interface195of the sleeve191can be slightly smaller than an outer diameter of the connection interface140of the cap102. The friction fit can be sufficiently strong to provide a fluid-tight seal between the cap102and the sleeve191, yet can allow the cap102to be removed from the sleeve191via manipulation by a user (e.g., without the use of ancillary tools). The fluid-tight seal can prevent evaporative loss of antiseptic from an interior of the assembly100when it is in the pre-use configuration and/or can maintain the sterility of the internal portions of the assembly100. In other or further embodiments, the connection interfaces140,195can include snap-fit devices, threads, and/or any other suitable attachment features. In the illustrated embodiment, a proximal portion of the connection interface140includes a chamfer120, which can assist in centering the cap102relative to the sleeve191when connecting the cap102to the sleeve191.

The proximal end124of the housing110(which is also a proximal end of the internal surface119, or more generally, of the sidewall112), can define a seal inhibitor125, which can include one or more contact regions126and one or more venting regions127. In the illustrated embodiment, the seal inhibitor125includes two contact regions126that are diametrically opposite from each other, and also includes two venting regions127that are diametrically opposite from each other and are angularly spaced from the contact regions. Other configurations of the seal inhibitor125are also possible, such as, for example, the seal inhibitors discussed in U.S. patent application Ser. No. 12/610,141, titled STERILIZATION CAPS AND SYSTEMS AND ASSOCIATED METHODS, filed Oct. 30, 2009, now published as U.S. Patent Application Publication No. 2010/0049170, which was previously incorporated by reference in this disclosure. Operation of the seal inhibitor125is discussed further below with respect toFIG. 13.

With reference toFIGS. 4C and 9, the inwardly directed portion of the internal surface119of the sidewall112can define a disinfection chamber122, which can include a connection interface130. Any suitable connection system may be used for the connection interface130. In the illustrated embodiment, the connection interface includes threads131. The connection interface130can be configured to attach the cap102to a medical connector in a secure yet selectively removable manner. For example, the cap102can be connected in any suitable manner with any suitable medical connector. In other embodiments, the connection interface130may include latches or prongs that are configured to snap over an outwardly extending rib of a connector, or may include one or more outwardly extending ribs over which one or more latches or prongs of the medical connector may snap. Other interfacing arrangements are also possible, which may include friction-fit, snap-fit, or other suitable mechanisms.

A proximal portion of the disinfection chamber122can be larger than a distal extension123of the chamber. In the illustrated embodiment, the disinfection chamber122defines three substantially frustoconical regions. The proximal region has a slightly tapered outer boundary that decreases in cross-sectional area in the distal direction; the intermediate region has a more pronounced tapered outer boundary that more rapidly decreases in cross-sectional area in the distal direction; and the distal region or distal extension123has a slightly tapered outer boundary that decreases in cross-sectional area in the distal direction at about the same rate as the proximal region. The intermediate and distal regions correspond with the proximal and distal regions, respectively, of the grasping platforms.

As can be appreciated fromFIG. 9, the constricted intermediate region of the disinfection chamber122can provide a reactive force to a distal end of the pad132when the cap102is secured to a medical connector. The reactive force can be sufficient to prevent the pad132from being forced into the distal extension123. In the illustrated embodiment, the threads131also provide resistive forces. Axial compression of the pad132as the cap102is coupled to a medical connector can swab the connector and deliver antiseptic133from the pad132into contact with the medical connector, as further discussed below. In some embodiments, the pad132may be resiliently deformable so as to regain a pre-use shape after a medical connector is decoupled from the cap102. In other embodiments, the pad132may instead be plastically deformable.

In various embodiments, the pad132can be configured to retain an antiseptic133. For example, the pad132can comprise any suitable sponge-like material, such as an elastomeric foam, any open-cell foam, felt, or non-woven fiber matrix, and can be configured to conform to the contours of a portion of a medical connector that is introduced into the disinfection chamber122(e.g., uneven surfaces of an end of a needleless injection site; see alsoFIGS. 12-14and the associated written description). The pad132can also comprise any closed-cell foam, as well as a solid elastomeric material, such as silicone or the like.

The pad132can have a series or network of openings or spaces therein that can retain the antiseptic133when the pad132is in an expanded state. For example, the antiseptic133can be received within, occupy, fill (or partially fill), wet, soak, or saturate at least a fraction of the pad132, or stated otherwise, can fill the pad132to a given concentration level. Compression of the pad132can cause antiseptic133to egress from the pad132so as to contact the medical connector. Resilient expansion of the foam upon removal of a compressive force can allow the pad132to soak up or absorb at least some of the antiseptic133that had previously been forced from the pad132. In some embodiments, the antiseptic133can comprise any liquid antiseptic, such as, for example, alcohol (e.g., isopropyl alcohol) at various concentrations (e.g., ranging from 50-90%), ethanol at various concentrations (e.g., ranging from 50-95%), and combinations of any alcohols with any antiseptics, or a dry material, such as chlorhexidine, ethylenediaminetetraacetic acid (EDTA), lodaphors, or any suitable combination thereof. Accordingly, although the antiseptic133is schematically depicted inFIG. 1as a series of droplets, the antiseptic133is not necessarily liquid and may fill the pad132to a greater or lesser extent than what is shown. In the illustrated embodiment, when the assembly100is in the pre-use condition, the pad132is in a relaxed, expanded, or uncompressed state in a longitudinal direction. It is noted that the pad132may be uncompressed in one or more dimensions, yet compressed in one or more other dimensions, when the assembly100is in the pre-use state. For example, the pad132can be expanded or in a relaxed state in a longitudinal direction, yet compressed radially inwardly via the sidewall112, when the assembly100is in the pre-use state.

In the illustrated embodiment, the pad132is substantially square in cross-section along its full longitudinal length when the pad132is in a relaxed orientation (seeFIG. 3). Such an arrangement can facilitate and/or reduce material costs associated with the manufacture of the pad132. At least a portion of the pad132(e.g., the corners thereof) may be compressed radially when the pad132is positioned within the housing112. Other rectangular cross-sections are also possible for the pad132, and in other or further embodiments, the pad132may define a rectangular cross-section along only a portion of the longitudinal length thereof. In other embodiments, at least a portion of the pad132may define a round cross-section, such as a circular, elliptical, or other ovoid shape. For example, the pad132can be cylindrical so as to have a circular cross-section. The pad132may define any other suitable shape, and may or may not be radially compressed when the assembly100is in the pre-use state.

With reference toFIGS. 5A-5C, the housing150of the male cap104can extend between a closed distal end and an open proximal end. The closed distal end does not permit any fluid flow therethrough and serves as a barrier between an interior of the housing150and an exterior environment. The open proximal end of the housing150is configured to receive at least a portion of a medical connector therein and/or to permit passage of at least a portion of the carriage200therethrough.

As viewed from the exterior (e.g., inFIGS. 5A and 5B), a shape and/or configuration of the distal end of the housing150can be similar or identical to the distal end of the housing110of the female cap102, which is discussed above. For example, in the illustrated embodiment, the housing150includes a body region136and a handle137with grasping platforms138, which when viewed exteriorly, are identical to the identically numbered features of the cap102. Accordingly, as can be seen inFIGS. 1 and 10A, when the assembly100is in the pre-use state, distal ends of an exterior thereof can be symmetrical about three mutually perpendicular planes. Other arrangements are also possible.

With continued reference toFIGS. 5A-5C, the housing150can include one or more protrusions197that are configured to mate or cooperate with the recesses116of the female cap102. In particular, each pair of coupled protrusions197and recesses116, or portions thereof, can operate as a separation assist107, as further discussed below with respect toFIGS. 10A and 10B. The housing150can include a lip, rim, or flange198that extends radially inwardly at a proximal end of the sleeve191. The housing150can define an external surface165and an internal surface166, each of which extends away from the flange198. The internal surface166of the cap104can define the connection interface195discussed above.

The flange198can contact the flange115of the female cap102, which can ensure the desired insertion depth of the cap102within the sleeve191. At least a portion of the flange198can be shaped complementarily to the flange115of the cap102. With reference toFIGS. 5A and 5B, the flange198can define a pair of faces199a,199bthat are angled in opposite directions.

With reference toFIG. 5C, the housing150can define a receptacle or cavity220within which the carriage200may move between the retracted and extended positions. The housing150can further define one or more movement constraining members230, which may extend inwardly from (e.g., project inwardly) or extend outwardly from (e.g., be recessed relative to) the interior surface166of the housing150. For example, the housing150can include one or more, two or more, three or more, or four or more movement constraining members230. The illustrated embodiment includes four movement constraining members230(only two of which are shown inFIG. 5C) that are angularly spaced from each other at approximately 90 degree intervals. Other suitable arrangements are also possible.

In the illustrated embodiment, each constraining member230comprises an inwardly projecting track, protrusion, or spline232. Each illustrated spline232includes a proximal stopping member or stop233, which can comprise a lock, latch, detent, or any other suitable stopping mechanism. In the illustrated embodiment, each proximal stop233is substantially wedge shaped and includes a distally angled entry face234, which can facilitate an overriding force or snap fit during manufacturing, and a transversely extending locking face235. The splines232also can include transversely extending distal stopping faces237,238. In the illustrated embodiment, the splines232are elongated structures (e.g., ribs) that extend substantially parallel to each other. In particular, the splines232are elongated in the longitudinal direction, and each may be substantially parallel to a longitudinal axis defined by the housing150. In some embodiments, the splines232can have a helical configuration, which can resist distal movement of the carriage200when the male cap104is coupled with a medical connector. Other suitable arrangements of the splines232are also contemplated.

With reference toFIG. 6, the biasing member202, which is a coil spring212in the illustrated embodiment, can be received within the cavity220. A distal end of the coil spring212can contact the distal stopping surface238, such that the distal stopping surface238can act as a resistive surface against which, or toward which, the coil spring212can be compressed. In other embodiments, the biasing member202can comprise any other suitable device that is configured to urge the carriage200in the proximal direction. For example, the biasing member202can comprise a resiliently deformable pad or support post of any suitable material, such as those described elsewhere herein. In other or further embodiments, the biasing member202can comprise one or more springs that are in forms other than helical, such as, for example, beam, leaf, conical, torsion, etc. Such springs may comprise any suitable material, such as, for example, metals and/or polymers. In some embodiments, the biasing member202may be formed integrally with the outer housing150and/or the inner housing210.

With reference toFIG. 7, the carriage200can be received within the cavity220and positioned at a proximal end of the spring212. As shown inFIGS. 7 and 8, the inner housing210of the carriage200can comprise a body or base250that is sized and shaped to translate along a longitudinal path through the cavity220. In the illustrated embodiment, the base250is substantially cylindrical. The base250can include a proximal extension252, which may define a smaller outer diameter than the base250. The illustrated proximal extension252is also substantially cylindrical, and is coaxial with the base250.

The inner housing210can include one or more movement constraining members253, which can be configured to cooperate with the movement constraining members230of the outer housing150in order to constrain, guide, or otherwise control movement of the inner housing210within the outer housing150. For example, the constraining members253of the inner housing210can be complementarily shaped relative to the constraining member230of the outer housing150. In the illustrated embodiment, each constraining member253of the inner housing210comprises a groove or channel254that is sized to receive at least a portion of a spline232. Accordingly, in the illustrated embodiment, the inner housing210comprises four channels254that are angularly spaced from each other by about 90 degrees.

The channels254can be configured to readily slide, glide, or otherwise translate over the splines232. Each channel254can be defined by sidewalls255, which may be substantially planar so as to smoothly pass over substantially planar walls of the splines232. Moreover, the sidewalls255may cooperate with the walls of the splines232to limit, inhibit, or prevent rotation of the inner housing210relative to the outer housing150. Other suitable arrangements for the constraining members230,253are also possible. For example, in other embodiments, the constraining members230of the outer housing150may comprise channels, whereas the constraining members253of the inner housing210can comprise outwardly projecting splines that can translate within the channels. In arrangements where the movement constraining members230,253are configured to prevent or inhibit rotation of the inner housing210relative to the outer housing150, the movement constraining members230,253may also be referred to as anti-rotation members.

As previously mentioned, in other embodiments, the splines232may be substantially helical. The channels254and sidewalls255thus may likewise define a substantially helical shape so as to appropriately interface with the helical splines232. In such an embodiment, the movement constraining members230,253thus may permit rotational movement between the inner housing210and the outer housing150, although the path of this rotational movement can be controlled by the movement constraining members230,253. Stated otherwise, the movement constraining members230,253can be configured to permit controlled, constrained, or limited rotational movement of the inner housing210relative to the outer housing150. A pitch of the helical constraining members230,253can be selected to achieve a desired operation of the male cap104. For example, the pitch may be selected so as to allow the biasing member202to move the carriage200proximally.

In the illustrated embodiment, each channel254includes a distal stopping member or stop256, which can comprise a lock, latch, or any other suitable stopping mechanism. In the illustrated embodiment, each distal stop256includes a substantially transversely extending face that is configured to contact the transversely extending locking faces235of the proximal stops233. The distal stops256of the inner housing210thus can cooperate with the proximal stops233of the outer housing150to limit the translational movement of the inner housing210. In particular, the stops233,256can cooperate to prevent the inner housing150from being pushed proximally out of the housing150by the coil spring212.

The base250of the inner housing210can include a distal surface257. A distal projection258can extend distally from the surface257. In the illustrated embodiment, the distal projection258is substantially cylindrical and is sized to be received within the coil spring212. The distal projection258can maintain the inner housing210in a centered orientation relative to the spring212.

In the illustrated embodiment, the base250of the inner housing210includes a chamfer260, which can assist in assembly of the male cap104. In particular, the chamfer260can aid in centering the inner housing210relative to the outer housing150when the inner housing210is inserted into the outer housing150.

An open proximal end of the inner housing210can be sized and shaped to receive at least a portion of a male protrusion of a medical connector. For example, the open proximal end of the housing210can be configured to receive at least a portion of a male luer. The open end of the housing210and the male luer can comply with ISO standards (e.g., ISO 594-1:1986 and ISO 594-2:1998). Other arrangements are also possible.

The proximal extension252described above may also be referred to more generally as a male projection241portion of the inner housing210. The projection241can be configured to couple with a medical connector that includes a male protrusion. The projection241includes a connection interface242that is configured to effect the coupling. In the illustrated embodiment, the projection241is substantially cylindrical, and the connection interface242comprises one or more threads243that are positioned at an outwardly facing surface of the cylinder. Any other suitable connection interface242, such as any of those described above, is possible. As can be seen inFIGS. 7,9, and11A, the connection interface242can be at an interior of the outer housing150when the inner housing210is in the retracted position, and at least a portion of the connection interface242can be at an exterior of the outer housing150when the inner housing210is in the extended position.

With reference toFIGS. 7 and 9, an inner surface264of the inner housing210can define a disinfection chamber268. As shown inFIG. 9, a proximal portion of the disinfection chamber268can include a proximal seal region271, which can be configured to form a fluid-tight seal with the male protrusion portion of a medical connector. For example, the seal region271may be shaped complementarily to an outer surface of a male protrusion of a medical connector with which the male cap104is configured to be used. In the illustrated embodiment, the proximal seal region271comprises a substantially frustoconical surface272that complies with ISO luer standards, as discussed above, such that a portion of a male luer can form a seal with the seal region271. The frustoconical surface272can be tapered so as to decrease in diameter in a distal direction. In other embodiments, the proximal portion of the disinfection chamber268may not be configured to form a fluid-tight seal with a male protrusion of a medical connector.

With continued reference toFIG. 9, the disinfection chamber268can further include an intermediate seal region273. In the illustrated embodiment, the intermediate seal region is formed by a rim, ridge, lip, or shelf274, which is defined by a short, substantially frustoconical portion of the inner housing210that increases in diameter in the distal direction. An outer edge of a proximal surface of the sealing member190can define a greater outer diameter than a minimum inner diameter of the shelf274such that the shelf274can maintain the sealing member190within the chamber268. The shelf274also can cooperate with the sealing member190to seal the chamber268when the assembly100is in the pre-use state, as further discussed below.

A distal end of the resilient support177, which may also be referred to as a post or a base element, can abut an inner surface of the distal projection258of the inner housing210. The resilient support177can be configured to provide a base against which the antiseptic reservoir or pad170can be compressed so as to force antiseptic133thereform. Accordingly, the resilient support177can be harder, stiffer, or less compliant than the pad170, and can be configured to compress, under a given force, to a smaller extent than the pad170does under the same force. For example, in various embodiments, the resilient support177can be no less than about 2, 3, or 4 times harder than the pad170.

The resilient support177can be elastically deformable such that compression of the support177from a relaxed orientation gives rise to a restorative force. The resilient support177can naturally return to the relaxed orientation upon removal of the compressive force. The resilient support177can comprise any suitable elastically deformable material. In some embodiments, the resilient support177comprises an elastomeric material, such as silicone. In certain embodiments, the resilient support177comprises a closed configuration (e.g., closed cell foam) or is otherwise nonabsorbent such that little or no antiseptic133that is expelled from the pad170is received into the resilient support177. In other or further embodiments, the resilient support177may comprise a spring (e.g., a compression coil spring). In other embodiments, such as mentioned elsewhere herein, a resilient support177is not used.

The pad170can comprise any suitable material, such as those described above with respect to other pads (including plastically deformable materials, in some instances), and may be elastically or resiliently deformable. In some embodiments, the pad170is attached to the resilient support177via any suitable adhesive or other attachment mechanism, although in other embodiments, no such attachment mechanisms are used. For example, the pad170and the resilient support177may be maintained in contact with each other due to a slight longitudinal compression of one or more of these components once the cap104is assembled (e.g., once the support177, the pad170, and the sealing member190are positioned between the support post168and the shelf174). Similarly, the pad170may be attached to the sealing member190, or it may maintain a substantially fixed orientation relative to the sealing member190without such attachment due to the resilience of the pad170and/or the support177, which are in a slightly compressed state.

In the illustrated embodiment, the pad170is substantially square in cross-section along its full longitudinal length when the pad170is in a relaxed orientation (seeFIG. 3). Such an arrangement can facilitate and/or reduce material costs associated with the manufacture of the pad170. At least a portion of the pad170(e.g., the corners thereof) may be compressed radially when the pad170is positioned within the inner housing210. Other rectangular cross-sections are also possible for the pad170, and in other or further embodiments, the pad170may define a rectangular cross-section along only a portion of the longitudinal length thereof. In other embodiments, at least a portion of the pad170may define a round cross-section, such as a circular, elliptical, or other ovoid shape. For example, the pad170can be cylindrical so as to have a circular cross-section. The pad170may define any other suitable shape, and may or may not be radially compressed when the assembly100is in the pre-use state.

As previously mentioned, the pad170and the support177can, in some embodiments, cooperate as a two-part biasing member176. It is to be understood that any other suitable biasing member176may be used, such as those described above. The biasing member176can urge the sealing member190in the proximal direction into sealing contact with the shelf274. The seal thus formed may be fluid-tight, and may prevent antiseptic133, whether in liquid or vapor form, from exiting the disinfecting chamber268prior to coupling of the male cap104to a medical connector. This proximal seal may be in place when the assembly100is in the pre-use configuration, as well as after the separation of the male and female caps104,102when the assembly100is opened.

The illustrated sealing member190comprises unitary piece of material that includes a cylindrical region and a conical region. The conical region can be well-suited to form a seal with a tip of the projection of a male medical connector. In some instances, an apex of the conical region can be received within a lumen322of a luer320when a medical connector is coupled with the cap104(see, e.g.,FIG. 11A). The sealing member190can be formed of any suitable material, such as, for example, an elastomer (e.g., silicone) or a thermoplastic, such as polypropylene, polycarbinate, acrylonitrile butadiene styrene (ABS), polyvinyl chloride (PVC), or rigid or semi-rigid thermoset plastic. The sealing member190can be formed in any suitable fashion, such as via molding or die cutting. In some embodiments, the sealing member190can be harder, more rigid, and/or less compliant than the pad170. The sealing member190may be integral to the pad170. For example, in some embodiments, the sealing member190may comprise a skin that is applied to the pad170, or may comprise a modification of a surface of the pad170(e.g., melting, heat forming, or the like). Other shapes of the sealing member190are possible, including, for example, flat or planar, disk-shaped, spherical, etc.

When the assembly100is in the pre-use state shown inFIG. 9, the coil spring212can be in a compressed state such that a biasing force tends to urge the carriage200in the proximal direction. This biasing force can be countered by interacting or cooperating surfaces of the inner male housing210and the female housing110. In the illustrated embodiment, a proximal end or portion of the threads243of the inner male housing210and a proximal end or portion of the threads131of the female housing110contact each other and thereby cooperate to prevent proximal movement of the carriage200. In further embodiments, the proximal portions of the threads131,243may engage one another. For example, the caps102,104may be rotated relative to each other during the manufacture of the assembly100so as to cause the threads131,243to engage each other.

Other suitable arrangements or cooperating features may be used to urge the carriage200into the retracted position and/or to retain the carriage200in the retracted position. For example, in some embodiments, cooperating tabs or flanges that are separate from the threads131,243may be used.

The connection interface195of the male cap104and the connection interface140of the female cap102can cooperate with each other to maintain the assembly100in the pre-use configuration. Any suitable connection interfaces may be used for this purpose. In the illustrated embodiment, the connection interface195of the male cap104comprises a region of the proximal end of the outer housing150, and the connection interface140of the female cap102comprises a region of the proximal end of the housing110. An inner surface of the proximal region of the outer housing150defines a similarly sized or smaller inner diameter than does an outer surface of the proximal end of the housing110of the female cap102, such that the proximal regions of the housings150,110can be tightly or securely fastened to each other in a friction fit. The friction fit can be sufficiently tight to resist biasing forces provided by the compressed spring212that would otherwise urge the carriage210in a proximal direction and thereby urge the female cap102away from the male cap104. The friction fit also can provide a fluid-tight seal that can prevent antiseptic133from evaporating from an interior of the closed assembly100to an exterior environment.

FIGS. 10A and 10Billustrate stages in a method of removing the female cap102from the assembly100. In some embodiments, it can be particularly advantageous to use the separation assists107in the removal process. For example, as just discussed, in some instances, the friction-fit engagement and/or fluid-tight seal between the caps102,104can be relatively tight. Moreover, in some instances, a slight vacuum may be present within the assembly100and/or may arise within the assembly100as the cap102is removed from or separated from the cap104. The separation assists107thus can advantageously facilitate removal of the cap102.

FIG. 10Aillustrates the assembly100in the pre-use state, with the faces116a,199aand116b,199bof the surfaces115,198in contact with each other. Each paired set of surfaces constitutes a separation assist107. In the illustrated embodiment the assembly100includes four separation assists107rotationally spaced from each other at intervals of approximately 90 degrees. Focusing now on an upper separation assist107that includes the faces116a,199a, the face116acan define an angle α (seeFIG. 4B) of about 20 degrees. The face199aof the sleeve191is at the same angle, although oppositely directed.

In order to separate the cap102from the sleeve191, the cap102can be rotated relative the sleeve191. In the illustrated embodiment, the cap102is rotated clockwise, which can cause the faces116a,199ato interact with each other and slide past each other. The cap102thus cams relative to the sleeve191as the rotational motion is converted into translational movement of the cap102away from the sleeve191, as shown by the arrow inFIG. 10B.

Where the angles α, β (seeFIG. 4B) of the surfaces116a,116bare identical, the same mechanical advantage may be present whether the cap102is rotated in the clockwise or counterclockwise directions. In other embodiments, the separation assists107can be configured to aid in separating the cap102from the sleeve191only when the cap102is rotated in one predetermined direction (e.g., either clockwise or counterclockwise). For example, the pair of faces116aor the pair of faces116bmay define an angle α or β, respectively, of 20 degrees so as to allow separation as shown inFIG. 10B, whereas the other pair of faces116a,116bmay be at an angle of about 90 degrees (i.e., approximately parallel to or extending through a central axis of the cap104) so as to prevent rotation and separation of the cap104. For example, in some embodiments, the faces116a,116bmay be configured to allow the caps102,104to be rotated only in a direction that would decouple threaded portions of the caps102,104, so as to thereby prevent initial or further coupling of the threaded portions of the caps102,104(which would tend to pull the caps102,104into tighter engagement with each other, rather than allow them to separate from each other). In other embodiments, one or more of the faces116a,116bmay be at larger or smaller angles α, β. For example, one or more of the angles α, β may be no more than about 15, 20, 1, 45, 60, or 75 degrees or no less than about 15, 20, 1, 45, 60, or 75 degrees. Other configurations of the separation assists107are also possible. For example, in some embodiments, the complementary surfaces of the flanges115,198can define angles as just described, but the surfaces may be rounded or otherwise non-planar.

Other arrangements of the separation assists107are contemplated. For example, in some embodiments, the female cap comprises one or more protrusions and the male cap comprises corresponding recesses. In further embodiments, the assembly100may be devoid of the separation assists107. Moreover, in some instances, a user may be able to separate the caps102,104from each other by pulling primarily or solely in a substantially longitudinal direction (e.g., without rotating the caps102,104relative to each other).

FIGS. 11A-11Dillustrate consecutive stages of the male cap104being coupled with a medical device300. InFIG. 11A, the male cap104has been removed from the female cap102. Separation of the female cap102from the male cap104can reduce and eliminate opposition to the biasing force of the spring212, such that carriage200is urged from the retracted position shown inFIG. 9to the extended position shown inFIG. 11A. When in the carriage is in the extended position, the male projection241can extend proximally beyond an edge of the outer housing150so as to be more readily accessible by the device300. The cap104may be said to be in a connection-ready or accessible state when it is in an orientation such as that shown inFIG. 11A, as the inner housing210is more readily accessible to the device300for connection thereto than it is when the male cap104is in the retracted orientation.

The proximal stops233of the outer housing150can cooperate with the distal stops256of the inner housing210, as discussed above. In some embodiments, once the proximal and distal stops233,256have engaged each other such that relative motion between the outer and inner housings150,210ceases, the spring212may continue to provide a biasing force to the inner housing210. For example, the spring212may remain somewhat compressed once the inner housing210has been extended. This residual biasing force can resist or oppose movement of the carriage200back toward the retracted position when the medical connector300is moved distally relative to the cap104during coupling, as described below. In other or further embodiments, the sleeve191and/or the carriage200may comprise a latch system or other suitable mechanism that can prevent distal movement of the carriage200relative to the sleeve191once the carriage200has been moved proximally past a predetermined position. An illustrative example of such a latch system is discussed below with respect toFIG. 17.

The medical device300includes a male protrusion319, which in the illustrated embodiment is a male luer320. As mentioned above, other arrangements of the male protrusion319are also contemplated. A tip321of the protrusion319, can be received within the disinfection chamber268prior to contacting the sealing member190. Stated otherwise, the sealing member190can be recessed relative to a proximal end of the inner housing210by a distance that is sufficiently great to permit at least a portion of the male luer320to be received within the inner housing210before the male luer contacts the sealing member190.

In the illustrated stage of the procedure, the luer320has been advanced sufficiently far into the disinfection chamber268to contact the sealing member190and to form a seal therewith. The connection interface242of the inner housing210has not yet engaged a connection interface312of the medical connector300at this stage, and the sealing member190is just beginning to move distally within the disinfection chamber268so as to break the proximal seal between the sealing member190and the shelf274.

One or more portions of the biasing member176(i.e., one or more of the resilient support177and the pad170) may provide a biasing force to the sealing member190that is smaller than the biasing force that the spring212provides to the carriage200. Accordingly, distal movement of the sealing member190may cause compression of one or more portions of the biasing member176, so as to break the proximal seal between the sealing member190and the shelf274, but may cause little or no compression of the spring212. The spring212thus may provide a suitable level of resistance to axial forces. In other or further embodiments, such as that described below with respect toFIG. 17, one or more latches may be used, which can ultimately provide a resistive force that permits distal movement of the sealing member190upon insertion of a portion of medial connector and/or that otherwise provides a suitable level of resistance to axial forces so as to permit desired operation of the male cap104.

InFIG. 11B, the luer320has been advanced slightly further into the disinfection chamber268, thereby compressing the pad170somewhat and forcing antiseptic133out of the pad170. The sealing member190can define an outer diameter than is smaller than an inner diameter of this portion of the disinfection chamber268such that a fluid path is present about an exterior of the sealing member190. Stated otherwise, the sealing member190has been urged distally to a position where a periphery or outermost perimeter of the sealing member190is spaced from the an interior surface of the inner housing210such that an opening, spacing, or gap that exists between the sealing member190and the interior surface of the inner housing210. This opening may function as a fluid port.

Antiseptic133thus can flow about the sealing member190and/or any other portion of an open region that exists between the interior surface of the inner housing210and the outer surfaces of the resilient support177, the pad170, the sealing member190, and the luer320. Further advancement of the luer320into the disinfection chamber268can cause the antiseptic133to fill this open region. However, the antiseptic133does not enter into the lumen322of the luer320due to the seal between the luer320and the sealing member190. Further advancement of the luer320into the disinfection chamber268also can strengthen the seal between the luer320and the sealing member190due to the increasing restorative forces that arise as the pad170is compressed.

As the pad170is softer or more compliant than the resilient support177, the pad170has been compressed to a much greater extent than the resilient support177at this stage. Indeed, in some embodiments, the resilient support177may compress only slightly or not at all at this stage.

In the illustrated embodiment, the interfaces242,312have just begun coupling with each other at the stage shown inFIG. 11B. The threaded interfaces242,312are configured to be rotated relative to each other for purposes of engagement and disengagement. As previously discussed, the movement constraining members230,253can cooperate with each other to limit or prevent rotation of the inner housing210relative to the outer housing150, which thus can facilitate coupling and/or decoupling of the medical connector300to/from the male cap104. For example, rotation of the housing150can directly impart or transmit torque to the inner housing210due to the movement constraining members230,253, which can provide a natural feel to a user. The handle137portion and/or the sleeve191portion of the male cap104thus can readily serve as a grip for rotationally coupling the male cap104to a medical connector. Moreover, in certain embodiments, upon engagement of the threaded interfaces242,312with each other, rotational motion of the medical connector300relative to the male cap104can draw the luer320into the disinfection chamber268without giving rise to any or significant longitudinally directed forces that would tend to urge the carriage200distally toward the retracted position. The handle137portion of the male cap104can conveniently be used for imparting or opposing rotational movement relative to the medical connector300.

InFIG. 11C, the luer320has been advanced even further into the disinfection chamber268, thereby compressing the pad170to a greater extent and forcing additional antiseptic133into the interior regions of the disinfection chamber268. In the illustrated embodiment, the resilient support177is shown as having been slightly compressed relative to its configuration in the stage shown inFIG. 66C, whereas the pad170has been nearly completely compressed, such that all or nearly all of the antiseptic133has been forced therefrom. Cooperation between the connection interfaces142,312can facilitate compression of the pad170and/or the resilient support177.

Although the outer surface of the luer320appears to be nearly parallel to and in contact with the luer-tapered surface272of the interior surface of the inner housing210, a fluid-tight seal may not have formed yet in this area. Accordingly, the antiseptic133may be permitted to cover the portion of the luer320that is within the chamber268, while in some embodiments, a small portion of antiseptic133may also be permitted to exit from the disinfection chamber268. The portion of the luer320that is within the disinfection chamber268thus may contact the antiseptic133so as to be disinfected thereby.

FIG. 11Dillustrates a final or fully coupled stage, or an end-of-stroke orientation, in which the luer320has been advanced even further into the disinfection chamber268such that the luer320forms a seal with the luer-tapered surface272of the inner housing210. Antiseptic133can be retained in all open portions of the disinfection chamber268that are between the seal formed by the luer320and the sealing member190and the seal formed by the luer320and the inner housing210. In the illustrated embodiment, a relatively large portion of the luer320, which includes all or most of the tip321, is in continual contact with the portion of the antiseptic133thus retained. This portion of the luer320can be bathed by the antiseptic133and disinfected thereby. In other embodiments, larger portions of the luer320can be bathed.

The deformable nature of the resilient support177can allow for distal movement of the pad170, even after the pad170has been fully compressed. Such an arrangement can allow for a range of acceptable lengths and diameters for the luer320. For example, shorter luers320than that illustrated in the drawings may still be able to fully compress the pad170so as to expel all antiseptic therefrom.

In other embodiments, the medical connector300may include a male protrusion other than a luer320, such as a male protrusion that is shaped substantially as a cylinder or in some other configuration, such as a taper having dimensions other than those used for luer systems. In some embodiments, the surface272may be shaped complementarily to the outer surface of such protrusions so as to for a seal therewith. In still other embodiments, the inner housing210may not form a seal with the protrusion.

When the luer320is removed from the chamber268, the restoration forces of the pad170and/or the resilient support177(i.e., the biasing member176) can maintain the seal between the luer320and the sealing member190, which can prevent antiseptic from entering into the lumen322of the luer320.

Each ofFIGS. 12-14illustrates the female cap102coupled with a separate needleless injection site340,360,380. The cap102can be versatile so as to couple with a variety of different types of medical connectors in a secure fashion that disinfects each type of medical connector. As can be seen in each ofFIGS. 12-14, coupling of the needleless injection sites340,360,380with the cap102can effect compression of one end of the pad132. This compression, along with rotation of the needleless injection site340,360,380can effect rubbing, swabbing, or scrubbing of the needleless injection site and disinfection thereof via the antiseptic133.

With reference toFIG. 12, the needleless injection site340can comprise a Clave® port available from ICU Medical, Inc. The needleless injection site340can include a housing342that defines a connection interface344. The needleless injection site340can further include an elastomeric seal346, which is shown in a closed configuration in which fluid access is not permitted into a fluid passageway348. Small crevices can exist between the housing342and the elastomeric seal346at an end of the needleless injection site340that is inserted into disinfection chamber1922. As the connection interface344cooperates with the connection interface1930defined by the sidewall112to draw the tip of the needleless injection site340into the disinfection chamber122, the pad132can be compressed so as to generally conform to the crevices. Compression of the pad132likewise can expel antiseptic133, which, in some instances, can fill in portions of the crevices that the pad132may not be able to contact directly. As the pad132is compressed, the seal346can remain closed so as to prevent antiseptic133from entering the fluid passageway348.

With reference toFIG. 13, the needleless injection site360can comprise a Q-Syte® port available from Becton, Dickinson and Company. The needleless injection site360can include a housing362and an elastomeric seal366, which is shown in a closed configuration in which fluid access is not permitted into a fluid passageway368. As with the needleless injection site340, small crevices can exist between the housing362and the elastomeric seal366. However, the crevices can exist at a side portion of the needleless injection site360, rather than at its tip. Nevertheless, as the needleless injection site360is advanced into the cap102, the pad132can be compressed so as to generally conform to these differently shaped crevices. Compression of the pad132likewise can expel antiseptic133, which, in some instances, can fill in portions of the crevices that the pad132may not be able to contact directly. The seal366can be maintained in the closed position during the coupling procedure, so as to prevent any of the antiseptic133from entering the fluid passageway368.

With reference toFIG. 14, the needleless injection site380can comprise a SmartSite® port available from Cardinal Health, Inc. The needleless injection site380can include a housing382and an elastomeric seal386, which is shown in a closed configuration in which fluid access is not permitted into a fluid passageway388. As with the needleless injection sites340,360, small crevices can exist between the housing382and the elastomeric seal386. However, these crevices can be in yet different positions than those of the needleless injection sites340,360. Nevertheless, as the needleless injection site380is advanced into the cap1102, the pad132can be compressed so as to generally conform to these differently shaped crevices. Compression of the pad132likewise can expel antiseptic133.

Each of the needleless injection sites340,360,380may advance into the cap102by different amounts. The cap102thus can be adaptable and versatile. Additional, non-limiting examples of needleless injection sites with which the cap102can selectively couple include the Clearlink® Site available from Baxter and the InVision-Plus® available from Rymed.

As shown inFIG. 13, in some arrangements, a portion of the seal inhibitor125can contact an outwardly projecting surface369of a needleless injection site360. In particular, the proximal end124of the cap102can contact the surface369at two separate contact regions126when the cap102is fully coupled with the needleless injection site360. In the venting regions127(not shown inFIG. 13, seeFIGS. 4A and 4B), the proximal end124of the cap102can be spaced from the surface369. Such an arrangement can allow venting of antiseptic from the disinfecting chamber122through the venting regions127into the surrounding environment.

FIGS. 15 and 16illustrate another embodiment of an assembly400that includes an embodiment of a female cap402and an embodiment of a male cap404, which can resemble the assembly100and caps102,104described above in certain respects. Accordingly, like features are designated with like reference numerals, with the leading digits “1” incremented to “4,” and the leading digit “2” incremented to “5.” Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the assembly400may 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 assembly400. Any suitable combination of the features and variations of the same described with respect to the assembly100can be employed with the assembly400, and vice versa. Such disclosure methods apply to additional embodiments disclosed hereafter, such as those shown in each ofFIGS. 17,18,19, and20.

The female cap402includes a housing410that contains a pad432. The housing410includes a sidewall412that defines a connection interface440. The male cap404includes an outer housing450that includes a telescoping carriage500therein. The outer housing450includes a sleeve491that defines a connection interface495. The connection interface495of the sleeve491is configured to cooperate with the connection interface440of the sidewall412to couple the male cap404to the female cap402so as to maintain the assembly400in the pre-use configuration. The coupled connection interfaces440,495may form a fluid-tight seal, such as described above.

In the illustrated embodiment, the connection interfaces495comprises an annular projection496that extends radially inwardly, and the connection interfaces440comprise a complementary annular recess441that also extends radially inwardly. Each of the projection496and the recess441can extend about at least a portion of the respective caps402,404and can function as a snap-fit connection interface. In other embodiments, the connection interface495may instead comprise a recess and the connection interface440may instead comprise a complementary projection. Other suitable connection interfaces are also contemplated.

An inner housing510of the carriage500can be somewhat shorter than the inner housing210described above. For example, the inner housing510may be devoid of a distal extension portion (such as the distal extension258). Correspondingly, a disinfecting chamber568defined by the inner housing510may be shorter than the disinfecting chamber268.

A biasing member476may comprise only a single piece, which in the illustrated embodiment is a resilient pad470that comprises an antiseptic therein. A sealing member490can be attached to or otherwise positioned at a proximal end of the pad470, and may function in a manner similar to the sealing member190described above.

The outer housing450can include one or more movement constraining members530that are configured to cooperate with one or more movement constraining members553of the inner housing510in manners such as described above. The movement constraining members530of the outer housing450can comprise splines532that are similar to the splines232describe above. However, in the illustrated embodiment, the splines532do not include stops (such as the stops232) at the proximal ends thereof. The movement constraining members553of the inner housing510can comprise channels554that are defined by sidewalls555. However, the movement channels554may not include stops (such as the stops256) at the distal ends thereof. Accordingly, the movement constraining members530,553may be configured primarily to limit rotational movement of the inner housing510relative to the outer housing450, without limiting longitudinal (e.g., translational) movement between the inner and outer housings510,450.

In some embodiments, movement of the carriage510in the longitudinal direction may be controlled or limited by a biasing member502. For example, the biasing member502can comprise a spring512that is attached to a distal end of the carriage512. The compressed spring512can move the carriage500from the retracted position shown inFIG. 15to an extended position (such as that shown inFIG. 11A). When the carriage500is in the extended position, the spring512may be in a natural or uncompressed state, such that the spring512naturally maintains the carriage500in the extended position. Any further proximal movement of the carriage500thus would give rise to a restorative or biasing force in the spring512that would tend to move the carriage500back to the extended position, which corresponds with the equilibrium position of the spring512. In other or further embodiments, as discussed further below, one or more of the inner and outer housings510,450can comprise latching or locking features that secure the carriage500in the extended position once it has been moved thereto.

Any suitable arrangement of antiseptic, pads, and/or sealing members may be used within the disinfecting chamber568. Examples of various suitable arrangements can be found in U.S. patent application Ser. No. 12/917,336, titled DISINFECTING CAPS AND SYSTEMS AND ASSOCIATED METHODS, filed Nov. 1, 2010, the entire contents of which were previously incorporated by reference herein.

FIG. 17illustrates an embodiment of an outer housing650that can be used in a male cap, which may be used with an assembly600. The assembly600can resemble any of the assemblies discussed above. The outer housing650can particularly resemble the outer housing150, and can include one or more movement constraining members630such as the movement constraining members230described above. For example, the movement constraining members630can include splines632that include proximal stops633, and the stops can be configured to prevent a carriage200,500from being fully extracted or urged from the outer housing650.

The assembly600can further include an additional movement constraining member631that is configured to maintain a carriage200,500in the extended position, or stated otherwise, that is configured to prevent a carriage200,500from being moved distally past a predetermined position once the carriage200,500has been moved from the retracted position to the extended position. Any suitable locking, latching, or retaining system may be used for the movement constraining member631. For example, in the illustrated embodiment, the outer housing650includes resilient arms680that are configured to move into a recess681. Only one arm680/recess681system is shown inFIG. 17, but additional such systems may be distributed about the outer housing650. The additional systems may be at the same longitudinal position, but angularly spaced about the housing650. The resilient arms680naturally angle inwardly toward an axial center of the outer housing650in a proximal direction. Movement of the carriage200,500in a proximal direction can urge the resilient arms radially outwardly into the recesses681. Once the carriage200,500has passed the resilient arms680, the arms680can return to their natural inwardly projecting orientation, and proximal surfaces of the arms can contact one or more distal surfaces of the carriage200,500(e.g., the distal surface257shown inFIG. 8) so as to prevent the carriage200,500from thereafter moving distally within the outer housing650.

The resilient arm680/recess681pair may be referred to as a latching system682. Any suitable arrangement of the latching system is contemplated, and the system may include detents or other locking features. In some embodiments, a biasing member202may include at least a portion of the latching system682. For example, in some embodiments, the biasing member202may include the resilient arm680or another suitable locking feature that is forced into the recess681once the biasing member202has been moved proximally to a predetermined position.

In the illustrated embodiment, the movement constraining members630,631are separate from each other. In other embodiments, they may be integral to each other. For example, in some embodiments, the resilient arm680may be incorporated into a spline632. In other embodiments, the spline632may include an additional stop, similar to the stop633. The additional stop may be at a longitudinal position similar to that of the arm680shown inFIG. 17. The stop may be configured to allow the carriage200,500to pass by it in the proximal direction so as to move from the retracted to the extended position, but may be configured to prevent the carriage200,500from moving distally past the stop thereafter. The stop may comprise a detent or any other suitable mechanism.

FIG. 18illustrates another embodiment of an assembly700that includes an embodiment of a female cap702and an embodiment of a male cap704. The assembly700can particularly resemble the assembly100, but can be devoid of a biasing member. In the illustrated embodiment, a selective engagement is established between a carriage800and the female cap702such that when the male and female caps704,702are separated for use, the carriage800is drawn by this selective engagement from the retracted position to the extended position. Once the carriage800has been drawn to the extended position, the selective engagement can be broken.

In the illustrated embodiment, the selective engagement between the female cap702and the carriage800may comprise an interfacing or interlocking of threads731of the female cap702and the threads843of the carriage800. For example, rather than mere contact between proximal ends of the threads131,243, such as shown inFIG. 9, so as to maintain the carriage200in the retracted position, a larger portion of the proximal portions of the threads731,843that are shown inFIG. 18may be engaged with each other so as to both maintain the carriage800in the retracted position and draw the carriage800from the retraced position when the female cap702is pulled away from an outer housing750of the male cap704. Once the female cap704has thus translated the carriage800to the desired position, the female cap702may be rotated relative to the carriage800(and, due to motion constraining members830,853, relative to the outer housing750as well) so as to disengage the threading731,843and fully separate the female cap702from the male cap704.

In the illustrated embodiment, a proximal end of the carriage800compresses a proximal end of a pad732that is within the female cap702when the assembly700is in the pre-use state. In other embodiments, the proximal end of the carriage800may be spaced from the pad732when the assembly is in the pre-use state so as not to compress the pad732.

In other or further embodiments, selective engagement between the female cap702and the carriage800can be effected by snap fitting, friction fitting, heat stake, and/or other suitable approaches. In some embodiments, the carriage800may be retained in the extended position, once it has been drawn thereto, by locks, detents, or other suitable features, as described above with respect toFIG. 17. For example, in some embodiments, the carriage800and/or the outer housing750may comprise a latch such that, once the carriage has been moved to the proximal position, the latch prevents distal motion of the carriage relative to the outer housing150.

FIG. 19illustrates another embodiment of an assembly900that includes an embodiment of a female cap902and an embodiment of a male cap904. As with the assembly700, the assembly900can be devoid of a biasing member that is configured to move a carriage1000from a retracted position to an extended position. Unlike the assembly700, the assembly900may further be devoid of features that couple the female cap902to the carriage1000so as to move the carriage1000from the retracted position to the extended position. Coupling of a medical connector (such as the connector300discussed above) to a connection interface1042of the carriage1000may draw the carriage1000from the retracted position to the extended position.

For example, in some embodiments, a sleeve portion991of an outer housing950of the male cap904can be sufficiently shallow to permit at least a portion of the connection interface312of the connector300(seeFIG. 11A) to engage a proximal portion of the connection interface1042. Tightening of the connector300onto the carriage1000, such as via rotation of the connector300relative to the carriage1000, can draw the carriage1000from the retracted position to the extended position. In particular, the carriage1000can translate relative to the outer housing as the threaded connection interface312is advanced onto threads1043of the connection interface1042. In some embodiments, a set of movement constraining members1030,1053can prevent the carriage1000from rotating relative to the outer housing950and can ensure that the only or primary relative movement between the outer housing950and the carriage1000is translational in a longitudinal direction.

In some embodiments, a male cap can be packaged independently of any female caps when in a pre-use state, such that it may not be part of an assembly. For example, as shown inFIG. 20, in some embodiments, a proximal end of a male cap1104may be substantially flat or planar (e.g., devoid of the protrusions197), and a removable cover1186may be secured to an outer housing1150of the cap1104in any suitable manner, such as, for example, via an adhesive. Preferably, the cover1186can be readily removed by a practitioner. The cover1186may include a graspable tab1187to aid in the removal thereof. The adhesive may be sufficiently strong to maintain the cover hermetically sealed about the proximal end of the outer housing1150, and the cover and adhesive may be sufficiently strong to counter the biasing force of a biasing member (e.g., the biasing member202) so as to maintain an inner housing in the retracted position. The removable cover1186can be formed of any suitable material, such as, for example, an impervious pliable material (e.g., foil, plastic, metallized-surface mylar). Examples of suitable covers are illustrated in U.S. patent application Ser. No. 12/917,336, titled DISINFECTING CAPS AND SYSTEMS AND ASSOCIATED METHODS, filed Nov. 1, 2010.

In some embodiments, the female caps102,402,702,902, which can be configured for use with medical connectors, may be replaced with caps having a sole or primary purpose of covering the male caps104,404,704,904prior to use so as to maintain the sterility of the male caps, so as to prevent evaporative loss from the male caps, and/or so as to maintain the carriage portions of the male caps in the retracted position. Additionally, as previously discussed with respect to the assembly100, in some embodiments, cooperation between the sealing member190and the inner housing210can form a seal that is sufficient to prevent evaporative loss from the male cap104.

The caps described herein, and components thereof, can be formed of, or coated with various colored materials or coatings. In some embodiments, the caps each include the same color. In other embodiments, the caps include different colors. Coloring the caps can, in some instances, provide advantages, such as ready identification of the type of cap, ready matching of a particularly colored cap with a particular type of medical connector, and the like.

The foregoing disclosure recites various embodiments that include caps that are configured to disinfect medical connectors. Certain of such caps can include an outer housing and an inner housing disposed within the outer housing. Illustrative examples of means for transitioning the inner housing from a retracted position to an extended position relative to the outer housing include the biasing members202,502, the threading731,843, and the connection interface1042. Illustrative examples of means for constraining movement of the inner housing relative to the outer housing include the movement constraining members230,253,530,553,630,631,830,853,1030,1053.

It will be understood by those having skill in the art that many changes may be made to the details of the above-described embodiments without departing from the underlying principles presented herein. For example, any suitable combination of features of the various embodiments of assemblies described above is contemplated.

References to approximations are made throughout this specification, such as by use of the terms “about” or “approximately.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about,” “substantially,” and “generally” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially planar” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely planar orientation.