Patent Description:
In order to decrease Catheter-related bloodstream infection (CRBSI) cases, which are high impact events with high costs and high associated mortality, needleless connector disinfection Cap space continues to grow at a rapid pace since disinfection caps were originally disclosed in <CIT> which <CIT> , and introduced on the market. Disinfection caps such as those disclosed in the <CIT> are illustrated in <FIG>, where cap <NUM> includes a disinfecting pad <NUM> and a lid <NUM>, and cap <NUM> includes a disinfecting pad <NUM> and lid <NUM>, as well as threads <NUM> on its inner circumference <NUM> to interlock with needleless connector hub. As illustrated in <FIG>, a plurality of disinfection caps <NUM>, such as cap <NUM> and/or cap <NUM> of <FIG>, can be disposed on a strip <NUM>, which includes an opening <NUM> for hanging strip <NUM> on an IV pole. In an IV pole hanging device <NUM>, strip <NUM> can serve as a common lid, for example having the same function as lid <NUM> and/or <NUM>, for caps <NUM> disposed thereon, such that removed cap <NUM> is ready for immediate placement on a needleless connector.

Disinfection caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines and early indications are that caps will also be incorporated into the <NUM> Infusion Nurses Standards (INS) guidelines.

In developed markets, when utilizing an IV catheter, a needleless connector will typically be used to close off the system and then subsequently accessed to administer medication or other necessary fluids via the catheter to the patient. INS Standards of Practice recommend the use of a needleless connector and state that it should be "consistently and thoroughly disinfected using alcohol, tincture of iodine or chlorhexidine gluconate/alcohol combination prior to each access. " The disinfection of the needleless connector is ultimately intended to aid in the reduction of bacteria that could be living on the surface and possibly lead to a variety of catheter related complications including the CRBSI events described before. Nurses will typically utilize a <NUM>% IPA alcohol pad to complete this disinfection task by doing what is known as "scrubbing the hub. " However, compliance to this practice is typically very low. In addition to a lack of compliance to "scrubbing the hub", it has also been noted through clinician interviews that there is often a variation in scrub time, dry time and the number of times the needleless connector is scrubbed.

Cap technology presents significant challenges associated with needleless connectors. All of the disinfection caps currently on the market contain <NUM>% isopropyl alcohol as the active disinfection ingredient. However, many of the needleless connector designs use Acrylic or similar material for the main housing. Acrylic has mild to poor chemical stability resistance to isopropyl alcohol over prolonged exposure times. Hence the isopropyl alcohol can cause chemical breakdown damage of Acrylic in the form of discoloration and/or cracking of the needleless connector material. In addition, nearly all of the needleless connectors on the market use silicone material for the fluid path valve designs. Silicone materials have a mild to poor chemical stability resistance to isopropyl alcohol over prolonged exposure times. This can lead to swelling of the silicone parts which can then cause the needleless connector valve to stick closed and/or fail to close (causing blood leakage). Additionally, increased silicone swelling could increase stress on the connector housing which could amplify the outer Acrylic needleless connector housing cracking issues.

Conventionally, in order to address the issue of isopropyl alcohol chemical incompatibility with needleless connector materials, disinfection cap having alcohol vents (such as those described in <CIT>; <CIT>; and <CIT>) have been developed. Such vents allow a cap to vent the disinfecting alcohol away from the needleless connectors faster in comparison to caps currently on the market which do not have such vents. Hence, alcohol venting can reduce chemical damage to the needleless connector materials.

However, such conventional vent features have some significant drawbacks. One drawback is that the venting feature can require forming dedicated venting holes in the cap, or be dependent on a significant undercut reign and/or an assembly of two molded parts, main cap housing and a thread ring, as described for example in <CIT>. Such conventional venting feature drives a cap design to require separate molding of the parts. These separate parts must then be assembled, then welded or adhesively bonded together. Accordingly, such a design has inherently higher tooling costs, manufacturing complexity, and production costs in comparison to for example a single shot molded cap housing design.

Hence if a disinfection cap could be developed with a venting feature that avoids undercuts it would eliminate the costly assembly and welding steps. In addition, if a disinfection cap could be developed with increased venting performance, it may further reduce needleless connector failures.

<CIT> discloses a cap configured to disinfect a medical connector, the cap having sealing features.

<CIT> disclosed a cleaner assembly for cleaning a medical device such as a luer connector.

<CIT> discloses a male connector provided with a luer part connected to the upstream end of a tube used in an enteral nutrition therapy.

In accordance with an aspect of the present invention, a disinfection cap comprises a housing including a closed top, an essentially cylindrical sidewall, and an open bottom formed by said sidewall with an opening to an inner cavity within said housing for receiving a tip including a mating feature of said needleless connector. A disinfection sponge can be configured within the inner cavity, with a removable cover sealing the opening to the inner cavity to seal the sponge within the inner cavity prior to use of the cap. The inner cavity comprises a multiple start thread pattern on an inner sidewall surface of the sidewall. The cap thread is sufficient to interlock with the mating feature of the needleless connector, the cap thread does not correspond to the mating feature of the needleless connector.

In accordance with another aspect of the present invention, at least one of a major diameter, a minor diameter, a pitch, a thread section profile, and a number of threads of the cap thread does not correspond to the mating feature of the needleless connector.

In accordance with another aspect of the present invention, a portion of the side wall forming the open bottom comprises an inner sidewall surface forming the opening to the inner cavity such that the open bottom does not form an airtight seal with an outer surface of the needleless connector when the needleless connector is securely engaged with the housing.

In accordance with another aspect of the present invention, the open bottom formed by said sidewall of the housing is not flat such that an exit space exists between a flat surface and the bottom of the housing, whereby venting of the disinfection sponge occurs through the opening to the inner cavity, essentially around an outside of the mating feature of the needleless connector and via the exit space to an outside of the cap housing.

In accordance with another aspect of the present invention, the open bottom formed by the sidewall of the housing includes an irregular bottom inner sidewall surface with one or more divots configured such that the opening to the inner cavity does not form an airtight seal with an outer surface of the needleless connector, whereby venting of the disinfection sponge occurs through the opening to the inner cavity, essentially around an outside of the mating feature of the needleless connector and via at least one of the divots to an outside of the cap housing.

In accordance with another aspect of the present invention, the housing comprises a flared lower portion formed at the open bottom comprising one or more divots regularly or randomly spaced along bottom inner sidewall surface defining the opening to the inner cavity.

In accordance with another aspect of the present invention, the cap thread comprises an extended portion extending below the open bottom formed by the sidewall such that an escape space exists between a surface of top portion of the needless connector and the open bottom when the cap thread interlocks with the needleless connector such that the extended portion contacts top portion of the needleless connector, whereby venting of the disinfection sponge occurs through the opening to the inner cavity, essentially around an outside of the mating feature of the needleless connector and via the escape space to an outside of the cap housing.

In accordance with another aspect of the present invention, a portion of the side wall forming the open bottom comprises a flared bottom portion having an inner sidewall surface forming the opening to the inner cavity such that the open bottom does not form an airtight seal with an outer surface of the needleless connector when the needleless connector is securely engaged with the housing, whereby venting of the disinfection sponge occurs through the opening to the inner cavity, essentially around an outside of the mating feature of the needleless connector, and between the inner wall surface of the flared bottom portion and the outer surface of the needleless connector to an outside of the cap housing.

In accordance with another aspect of the present invention, the open bottom formed by the sidewall of said housing is essentially flat.

In accordance with another aspect of the present invention, the open bottom formed by said sidewall of the housing is not flat such that an exit space exists between a flat surface and the bottom of said housing.

In accordance with another aspect of the present invention, the inner cavity comprises an upper region terminating in a closed top, and a lower region terminating in an opening to the inner cavity, the lower region comprises the cap thread, and the upper region comprises protrusions into the inner cavity configured to contact and/or engage the sponge.

In accordance with another aspect of the present invention, the sidewall comprises an inner sidewall surface including a plurality of sections between the cap thread, each of the sections having a slope with respect to the longitudinal axis of the housing of the cap. At least one of the sections forming the open bottom expands away from the longitudinal axis to form the flared bottom portion.

In accordance with another aspect of the present invention, the inner cavity comprises an upper region terminating in a closed top, and a lower region terminating in the opening to the inner cavity. The inner sidewall surface comprises a transition section having a linear or curved surface where the inner sidewall surface transitions from the lower region to the upper region such that cross sectional area at bottom of the transition section in the lower region is greater than cross sectional area at top of the transition section in the upper region.

In accordance with another aspect of the present invention, the sponge is secured from being displaced into the upper region when the cap thread interlocks with the mating feature of the needleless connector, such that the sponge maintains contact with the needleless connector and remains away from an inner surface of the closed top.

In accordance with another aspect of the present invention, the opening to the inner cavity formed by the inner sidewall surface of the bottom portion is essentially circular and comprises an opening diameter, and the opening diameter is larger than a flange diameter of the needless connector, such that said opening diameter causes a venting gap between the inner sidewall surface of the housing and the needless connector, whereby the opening to the inner cavity comprises the venting gap and the venting of the disinfection sponge occurs through the opening to the inner cavity, essentially around the outside of the mating feature of the needleless connector and via the venting gap, to the outside of the cap housing.

In accordance with another aspect of the present invention, the sidewall comprises the inner sidewall surface in the lower region including a plurality of sections between the cap thread, each of the sections having essentially the same slope with respect to the longitudinal axis of the housing of the cap, and at least one of the sections forming the open bottom, the at least one of the sections expanding away from the longitudinal axis to form the flared bottom portion.

In accordance with another aspect of the present invention, at least one cap thread on the inner sidewall surface of the sidewall comprises a protrusion formed on a least a portion of the cap thread to facilitate the interlocking with the mating feature of the needleless connector.

In accordance with another aspect of the present invention, at least a portion of at least one cap thread comprises a non-engaging portion that does not engage the mating feature of the needleless connector.

In accordance with another aspect of the present invention, the cap thread comprises at least one interlocking portion formed on a least a portion of the cap thread to facilitate interlocking with the mating feature of the needleless connector, and at least one non-engaging portions that does not engage the mating feature of the needleless connector.

In accordance with another aspect of the present invention, a device comprising a strip, and a plurality of disinfection caps according to exemplary embodiments of the present invention disposed on said strip.

In accordance with an exemplary implementation of the present invention, the strip of the device is essentially flat and comprises a plurality of sections separated by perforations in the strip, each of the sections comprising at least one of the plurality of the disinfection caps disposed thereon, whereby the perforations facilitate detachment at the perforations of at least one of said sections with the at least one disinfection cap disposed thereon.

In accordance with another exemplary implementation of the present invention, the strip comprises the removable cover for the plurality of the disinfection caps disposed thereon, whereby each cap of the plurality of caps is attached to the strip at the bottom of the cap and is peelable off the strip uncovering the opening to the inner cavity of the cap when peeled off said strip.

In accordance with yet another exemplary implementation of the present invention, the strip is double-sided comprising opposing sides each having a plurality of disinfection caps disposed thereon.

In accordance with an alternative exemplary implementation of the present invention, the strip comprises a plurality of prongs attached to, and extending away from, the surface of the strip, whereby each cap of said plurality of caps is removably attached to the strip by one of the prongs connected to exterior surface of the closed top of the cap.

In accordance with yet another exemplary implementation of the present invention, the device comprises an attachment portion for selectively placing the strip having the caps attached thereto on an IV pole.

In accordance with an exemplary embodiment of the present invention, a multiple start thread pattern for use in a medical device connector comprises: a first start thread path wherein the first start thread path has a major profile, a minor profile, a pitch, and a first thread section profile; at least a second start thread path wherein the second start thread path has a major profile, a minor profile, a pitch, and a second thread section profile. The first thread section profile and the second thread section profile are different.

In accordance an exemplary implementation of the present invention, first and second start thread paths have equivalent pitches and are configured to interface with a complimentary thread of a secondary medical device connector having a major profile and a substantially equivalent pitch to the pitches of the first and second start thread paths.

In accordance with another exemplary implementation of the present invention when the complimentary thread is engaged to the first and second start thread paths a first helical void is formed by the space enclosed by the complimentary thread and the first start thread path and a second helical void is formed by the space enclosed by the complimentary thread and the second start thread path. The second helical void is larger than the first helical void.

In accordance with yet another exemplary implementation of the present invention, the first start thread path and said second start thread path further comprise respective root section profiles and respective crest section profiles. The respective root section profiles are substantially similar and the respective crest section profiles are substantially different.

In accordance with the present invention, the first start thread path and the second start thread path form a female thread pattern and the complimentary thread of the secondary medical device connector has a male thread pattern.

In accordance with an example being not part of the present invention, the first start thread path and the second start path form a male thread pattern and the complimentary thread of the secondary medical device connector has a female thread pattern.

In accordance with yet another exemplary implementation of the present invention, the second start thread path interfaces with the complimentary thread substantially tangentially.

In accordance with yet another exemplary implementation of the present invention, the first start thread path interfaces with the complimentary thread to substantially engage the complimentary thread.

In accordance with yet another exemplary implementation of the present invention, the first and second start thread paths have substantially equivalent pitches.

In accordance with an exemplary embodiment of the present invention, a cap which incorporates the multiple start thread pattern comprises an inner cavity and an airflow path from a proximal end of the cap to the inner cavity is formed by the first and second helical voids when the complimentary thread is engaged to the multiple start thread pattern.

In accordance with an exemplary implementation of the present invention, the cap further comprises a disinfection agent retention member retained in the inner cavity essentially at a distal end of the cap.

In accordance with another exemplary implementation of the present invention, the cap further comprises an inner surface having the first and second start thread paths and receiving the secondary medical device connector.

In accordance with yet another exemplary implementation of the present invention, the inner surface of the cap forms an essentially frustoconical inner cavity having a larger cross section at the proximal end of the cap.

In accordance with yet another exemplary implementation of the present invention, the inner surface of the cap forms an essentially cylindrical inner cavity having a cross section greater than the major profile of the complimentary thread of the secondary medical device connector.

Objects, advantages, and salient features of the invention will become apparent from the following detailed description, which, taken in conjunction with the annexed drawings, discloses exemplary embodiments of the invention.

The above benefits and other advantages of the various embodiments of the present invention will be more apparent from the following detailed description of exemplary embodiments of the present invention and from the accompanying drawing figures, in which:.

Throughout the drawings, like reference numbers will be understood to refer to like parts, components and structures.

The matters exemplified in this description are provided to assist in a comprehensive understanding of exemplary embodiments of the invention. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope of the invention. Also, descriptions of well-known functions and constructions are omitted for clarity and conciseness.

Exemplary embodiments of the present invention provide a disinfection cap that can have an increased venting performance, while using a novel single shot moldable cap design features where disinfection fluid venting can be accomplished by incorporating cap features for (thread major diameter, thread minor diameter, thread pitch, thread section profile and number of threads features) that do not correspond to the mating features on the IV catheter needleless connector hub. The cap's thread minor features grip the needleless connector thread major features causing an interference friction fit between the two parts. These non-corresponding thread features result in significant spiral venting paths around the outside of the needleless connector thread major sections between the cap and IV hub. These paths lead from the alcohol soaked disinfection sponge in the upper section of the cap, spirally down the inner diameter of the cap and vent out of the bottom of the cap to atmosphere.

As would be readily appreciated by skilled artisans in the relevant art, in the description that follows, definition of "a feature that does not correspond to the mating feature" is: a feature that is not identical to the mating feature in all essentials or respects. Definition of "identical" is: outside of industry average tolerance ranges for injection moldable plastic parts and injection moldable plastic parts assemblies. Also, it is to be noted that, while descriptive terms such as "tip", "hub", "thread", "sponge", "protrusion", "slope", and others are used throughout this specification to facilitate understanding, it is not intended to limit any components that can be used in combinations or individually to implement various aspects of the embodiments of the present invention.

Furthermore, the cap thread feature sizing can be optimized in relation to the needleless connector thread or mating features as to maximize the cap's venting rate performance while still meeting other product requirements. Manufacturing injection demolding can be accomplished via spiral ejection of the parts or rotating mold core. Thus, two shot injection and/or plastic parts assembly is not required with design concepts according to exemplary embodiments of the present invention.

Referring now to the drawings, wherein like reference numerals designate identical or corresponding parts throughout the several views, embodiments of the present invention are described as follows.

According to an exemplary implementation of the embodiments of the present invention as illustrated in <FIG>, and <FIG>, a cross thread disinfection cap <NUM> can fit onto a tip or hub <NUM> of needless connector <NUM> and comprises housing <NUM> comprising: a closed top <NUM>; an essentially cylindrical sidewall <NUM> with an outer sidewall surface <NUM>; and an open bottom <NUM> with an opening <NUM> to an inner cavity <NUM> within housing <NUM> for receiving tip of a needleless connector <NUM>. The bottom <NUM> formed by sidewall <NUM> of housing <NUM> is not flat such that space <NUM> exists between a flat surface <NUM> and bottom <NUM> of cap <NUM>. The inner cavity <NUM> accommodates an alcohol soaked disinfection sponge <NUM> and has threads (or mating feature) <NUM> on inner sidewall surface <NUM> of sidewall <NUM>. The diameter (major diameter <NUM> and/or minor diameter <NUM>) of threads <NUM> of the cap <NUM> does not correspond to the thread (or mating feature) <NUM> of the needleless connector <NUM>. A removable cover <NUM> can be attached to bottom <NUM> of cap <NUM> to seal inner cavity <NUM> including disinfection sponge <NUM>.

In addition, as further illustrated in <FIG> and <FIG>, according to an exemplary implementation, thread pitch, thread section profile, and/or number-of-threads of cap <NUM> do not correspond to the thread <NUM> of the needleless connector <NUM>. Since the threads <NUM> of the cap <NUM> do not correspond to the thread <NUM> of the needleless connector <NUM>, venting <NUM> of the alcohol soaked disinfection sponge <NUM> occurs through the one opening <NUM> to the inner cavity <NUM>, essentially around the outside of threads <NUM> of the needleless connector <NUM> and via space <NUM> to the outside (atmosphere) of the cap housing <NUM>.

According to another exemplary implementation of the embodiments of the present invention as illustrated in <FIG>, a thread major gap disinfection cap <NUM> can fit onto a tip <NUM> of needless connector <NUM> and comprises housing <NUM> comprising: a closed top <NUM>; an essentially cylindrical sidewall <NUM> with an outer sidewall surface <NUM>; and an open bottom <NUM> with an opening <NUM> to an inner cavity <NUM> within housing <NUM> for receiving tip of a needleless connector <NUM>. The bottom <NUM> formed by sidewall <NUM> of housing <NUM> is not flat such that space <NUM> exists between a flat surface <NUM> and bottom <NUM> of cap <NUM>. The inner cavity <NUM> accommodates an alcohol soaked disinfection sponge <NUM> and has threads <NUM> on inner sidewall surface <NUM> of sidewall <NUM>. A removable cover <NUM> can be attached to bottom <NUM> of cap <NUM> to seal inner cavity <NUM> including disinfection sponge <NUM>.

The pitch of threads <NUM> corresponds to the pitch of thread <NUM> of needleless connector <NUM>. However, the profile (major profile <NUM> and/or minor profile <NUM>) of threads <NUM> of the cap <NUM> does not correspond to the thread <NUM> of the needleless connector <NUM>. Since the threads <NUM> of the cap <NUM> do not correspond to the thread <NUM> of the needleless connector <NUM>, venting <NUM> of the alcohol soaked disinfection sponge <NUM> occurs through the one opening <NUM> to the inner cavity <NUM>, essentially around the outside of threads <NUM> of the needleless connector <NUM> and via space <NUM> to the outside (atmosphere) of the cap housing <NUM>.

According to yet another exemplary implementation of the embodiments of the present invention illustrated in <FIG>, and <FIG>, a thread-castellartions-design disinfection cap <NUM> can fit onto a tip <NUM> of needless connector <NUM> and comprises housing <NUM> comprising: a closed top <NUM>; an essentially cylindrical sidewall <NUM> with an outer sidewall surface <NUM>; and an open bottom <NUM> with an opening <NUM> to an inner cavity <NUM> within housing <NUM> for receiving tip <NUM> of a needleless connector <NUM>. The bottom <NUM> formed by sidewall <NUM> of housing <NUM> includes an irregular bottom inner sidewall surface <NUM> with divots <NUM> such that the opening <NUM> does not form an airtight seal with outer surface <NUM> of needleless connector <NUM>.

In an exemplary implementation, housing <NUM> comprises a flared lower portion <NUM> formed at bottom <NUM>, which includes divots <NUM>. Any number, one or more, of divots <NUM> can be regularly or randomly spaced along bottom inner sidewall surface <NUM>. The inner cavity <NUM> accommodates an alcohol soaked disinfection sponge <NUM>, similarly to an example of <FIG>, such that sponge <NUM> contact and disinfects at least tip <NUM> of needleless connector <NUM>. Inner cavity <NUM> comprises threads <NUM> on inner sidewall surface <NUM> of sidewall <NUM>.

The pitch of threads <NUM> corresponds to the pitch of thread <NUM> of needleless connector <NUM>. However, the profile (major profile <NUM> and/or minor profile <NUM>) of threads <NUM> of the cap <NUM> does not correspond to the thread <NUM> of the needleless connector <NUM>. Since the threads <NUM> of the cap <NUM> do not correspond to the thread <NUM> of the needleless connector <NUM>, venting <NUM> of the alcohol soaked disinfection sponge <NUM> occurs essentially around the outside of threads <NUM> of the needleless connector <NUM>, and through one or more divots <NUM> of opening <NUM> to the inner cavity <NUM>, to the outside (atmosphere) of the cap housing <NUM>. The bottom <NUM> formed by sidewall <NUM> of housing <NUM> can be, but does not have to be, essentially flat (in contrast to exemplary embodiment of <FIG> where space <NUM> exists between a flat surface <NUM> and bottom <NUM> of cap <NUM>). A removable cover <NUM> can be attached to bottom <NUM> of cap <NUM> to seal inner cavity <NUM> including disinfection sponge <NUM>.

According to yet further exemplary implementation of the embodiments of the present invention as illustrated in <FIG>, <FIG>, an extended-thread-design gap disinfection cap <NUM> can fit onto a tip <NUM> of needless connector <NUM> and comprises housing <NUM> comprising: a closed top <NUM>; an essentially cylindrical sidewall <NUM> with an outer sidewall surface <NUM>; and an open bottom <NUM> with an opening <NUM> to an inner cavity <NUM> within housing <NUM> for receiving tip of a needleless connector <NUM>. The inner cavity <NUM> comprises an upper region <NUM> and a lower region <NUM>, and accommodates an alcohol soaked disinfection sponge <NUM>. Lower region <NUM> comprises engaging threads <NUM> on inner sidewall surface <NUM> of sidewall <NUM> for engaging thread <NUM> of needleless connector <NUM>. Threads <NUM> include an extended portion <NUM>, which extends below bottom <NUM> formed by sidewall <NUM> of housing <NUM> such that space <NUM> exists between a surface <NUM> of top portion <NUM> of needless connector <NUM> and bottom <NUM> of cap <NUM> when cap <NUM> is installed onto connector <NUM> such that extended portion <NUM> contacts top portion <NUM> of needleless connector <NUM>.

In an exemplary implementation, upper region <NUM> can comprise protrusions <NUM> from inner sidewall surface <NUM>, and/or protrusions <NUM> from inner surface of top <NUM>, engaging or contacting disinfection sponge <NUM>. The pitch of engaging threads <NUM> corresponds to the pitch of thread <NUM> of needleless connector <NUM>. However, the profile (major profile <NUM> and/or minor profile <NUM>) of engaging threads <NUM> of the cap <NUM> does not correspond to the thread <NUM> of the needleless connector <NUM>. Since engaging threads <NUM> of cap <NUM> do not correspond to the thread <NUM> of the needleless connector <NUM>, venting <NUM> of the alcohol soaked disinfection sponge <NUM> occurs through the one opening <NUM> to the inner cavity <NUM>, essentially around the outside of threads <NUM> of the needleless connector <NUM> and via space <NUM> to the outside (atmosphere) of the cap housing <NUM>. In an exemplary implementation, bottom <NUM> formed by sidewall <NUM> of housing <NUM> can be, but does not have to be, essentially flat (in contrast to exemplary embodiment of <FIG> where space <NUM> exists between a flat surface <NUM> and bottom <NUM> of cap <NUM>). A removable cover <NUM> can be attached to bottom <NUM> of cap <NUM> to seal inner cavity <NUM> including disinfection sponge <NUM>.

According to still further exemplary implementation of the embodiments of the present invention as illustrated in <FIG>, a disinfection cap <NUM> can fit onto a tip <NUM> of needless connector <NUM> and comprises housing <NUM> comprising: a closed top <NUM>; sidewall <NUM> with an outer sidewall surface <NUM>; and an open bottom <NUM> with an opening <NUM> to an inner cavity <NUM> within housing <NUM> for receiving tip of a needleless connector <NUM>. The inner cavity <NUM> comprises an upper region <NUM> and a lower region <NUM>, and accommodates an alcohol soaked disinfection sponge <NUM>. The bottom <NUM> formed by sidewall <NUM> of housing <NUM> includes a flared bottom portion <NUM> having an inner sidewall surface <NUM> such that the opening <NUM> does not form an airtight seal with outer surface <NUM> of needleless connector <NUM> when tip of connector <NUM> is securely engaged at least within lower region <NUM> of cavity <NUM>. A removable cover <NUM> can be attached to bottom <NUM> of cap <NUM> to seal inner cavity <NUM> including disinfection sponge <NUM>.

In an exemplary implementation, opening <NUM> to inner cavity <NUM> formed by inner sidewall surface <NUM> is essentially circular and has an opening diameter <NUM>, which is larger than a flange diameter <NUM> of outer surface <NUM> of needless connector <NUM>, such that opening diameter <NUM> causes a venting gap <NUM> between inner sidewall surface <NUM> and outer surface <NUM> needless connector <NUM>.

Lower region <NUM> comprises threads <NUM> on inner sidewall surface <NUM> of sidewall <NUM> for engaging thread <NUM> of needleless connector <NUM>. In an exemplary implementation, upper region <NUM> can comprise protrusions <NUM> on inner sidewall surface <NUM> and/or protrusions (not shown) on inner surface of top <NUM> (such as protrusions <NUM> illustrated in example of <FIG>) engaging or contacting disinfection sponge <NUM>.

The pitch of threads <NUM> corresponds to the pitch of thread <NUM> of needleless connector <NUM>. However, the profile (major profile <NUM> and/or minor profile <NUM>) of threads <NUM> of the cap <NUM> does not correspond to the thread <NUM> of the needleless connector <NUM>. Since engaging threads <NUM> of cap <NUM> do not correspond to the thread <NUM> of the needleless connector <NUM>, venting <NUM> of the alcohol soaked disinfection sponge <NUM> occurs essentially around the outside of threads <NUM> of the needleless connector <NUM> and through opening <NUM> to the inner cavity <NUM> to the outside (atmosphere) of the cap housing <NUM>. In an exemplary implementation, venting <NUM> occurs through opening <NUM> via venting gap <NUM>.

The bottom <NUM> formed by sidewall <NUM> of housing <NUM> can be, but does not have to be, essentially flat (in contrast to exemplary embodiment of <FIG> where space <NUM> exists between a flat surface <NUM> and bottom <NUM> of cap <NUM>).

According to an exemplary implementation of an embodiment of the invention as illustrated in <FIG>, <FIG> and <FIG>, inner sidewall surface <NUM> in lower region <NUM> of cap <NUM> can include sections 1530C, 1530D, 1530E, and 1530F essentially between threads <NUM>, each section having a slope with respect to the longitudinal axis A. In a further exemplary implementation, inner sidewall surface <NUM> in sections 1530E and 1530F expands away from longitudinal axis A forming a flared out opening <NUM>. In yet further exemplary implementation inner cross sectional area at top of section 1530C can be smaller than cross sectional area at bottom of section 1530F, which forms opening <NUM>. In a still further exemplary implementation, cross sectional area at top of section 1530D can be configured to impede further insertion of needleless connector <NUM> into cavity <NUM> such that tip <NUM> of needleless connector <NUM> stops essentially at top of section 1530D as illustrated in the example of <FIG>.

In yet further exemplary implementation, inner sidewall surface <NUM> in upper region <NUM> of cap <NUM> can include sections1530AA and 1530A, essentially between protrusions <NUM>, each section having a slope with respect to the longitudinal axis A. In still further exemplary implementation, inner sidewall surface <NUM> can include a transition section 1530B have a linear (see example of <FIG>) or a curved (see example of <FIG>, <FIG>, <FIG> and <FIG>) surface where inner sidewall surface <NUM> transitions from lower region <NUM> to upper region <NUM> such that cross sectional area at bottom of section 1530B in region <NUM> is greater than cross sectional area at top of section 1530B in region <NUM>. Protrusions <NUM> and/or smaller cross sectional area at top of section 1530B can prevent sponge <NUM> from being displaced into upper region <NUM> when cap <NUM> engages needleless connector <NUM>, such that sponge <NUM> can be compressed and/or retained in within a certain region of cavity <NUM>, for example essentially within sections 1530B and 1530C, when tip <NUM> of connector <NUM> is secured within cavity <NUM> of cap <NUM>.

In yet further exemplary implementation of an embodiment of the invention as illustrated in <FIG>, inner sidewall surface <NUM> in lower region <NUM> of cap <NUM> can include sections1530C, 1530D, and 1530E essentially between threads <NUM>, and section 1530Fas the bottom most section, or an aperture step, below section 1530F. All sections have essentially the same slope or angle with respect to the longitudinal axis A. However, unlike an exemplary implementation illustrated in <FIG>, sections 1530C, 1530D, 1530E, and/or 1530F are not collinear.

In yet further exemplary implementation of an embodiment of the invention as illustrated in <FIG>, inner sidewall surface <NUM> in lower region <NUM> of cap <NUM> can include essentially collinear <NUM> sections 1530C, 1530D and 1530E essentially between threads <NUM> all sections having essentially the same slope or angle with respect to the longitudinal axis A. However, unlike an exemplary implementation illustrated in <FIG>, section 1530F can be configured as an integral bottom most portion of section 1530E.

In yet another exemplary implementation, cap <NUM> comprises ridges <NUM> formed on outer sidewall surface <NUM> of housing <NUM>, for example to facilitated better gripping of cap <NUM> such as when handling cap <NUM> to remove cover <NUM>, engage needleless connector <NUM>, and/or disengage needleless connector <NUM>.

According to yet further exemplary implementation of the embodiments of the present invention as illustrated in <FIG>, <FIG>, a disinfection cap <NUM> can fit onto a tip <NUM> of needless connector <NUM> and comprises housing <NUM> comprising: a closed top <NUM>; sidewall <NUM> with an outer sidewall surface <NUM>; and an open bottom <NUM> with an opening <NUM> to an inner cavity <NUM> within housing <NUM> for receiving tip of a needleless connector <NUM>. The inner cavity <NUM> accommodates an alcohol soaked disinfection sponge <NUM>. The bottom <NUM> formed by sidewall <NUM> of housing <NUM> includes a bottom portion <NUM> having an inner sidewall surface <NUM> such that the opening <NUM> does not form an airtight seal with outer surface <NUM> of needleless connector <NUM> when tip of connector <NUM> is securely engaged within cavity <NUM>. As in the example of <FIG>, a removable cover such as <NUM> can be attached to bottom <NUM> of cap <NUM> to seal inner cavity <NUM> including disinfection sponge <NUM>.

In an exemplary implementation, opening <NUM> to inner cavity <NUM> formed by inner sidewall surface <NUM> is essentially circular and has an opening diameter 2026A, which is larger than a flange diameter <NUM> of outer surface <NUM> of needless connector <NUM>, such that opening diameter 2026A causes a venting gap <NUM> between inner sidewall surface <NUM> and outer surface <NUM> of needless connector <NUM>.

Inner cavity <NUM> comprises threads <NUM> on inner sidewall surface <NUM> of sidewall <NUM> for engaging thread <NUM> of needleless connector <NUM>. In an exemplary implementation, at least a portion of threads <NUM> can include a protrusion 2040A to facilitate a more secure engagement with thread <NUM> of needless connector <NUM>.

The pitch of threads <NUM> corresponds to the pitch of thread <NUM> of needleless connector <NUM>. However, the profile (major profile <NUM> and/or minor profile <NUM>) of threads <NUM> of the cap <NUM> does not correspond to the thread <NUM> of the needleless connector <NUM>. Since engaging threads <NUM> of cap <NUM> do not correspond to the thread <NUM> of the needleless connector <NUM>, venting <NUM> of the alcohol soaked disinfection sponge <NUM> occurs essentially around the outside of threads <NUM> of the needleless connector <NUM> and through opening <NUM> to the inner cavity <NUM> to the outside (atmosphere) of the cap housing <NUM>. In an exemplary implementation, venting <NUM> occurs through opening <NUM> via venting gap <NUM>. A removable cover <NUM> can be attached to bottom <NUM> of cap <NUM> to seal inner cavity <NUM> including disinfection sponge <NUM>.

According to an exemplary implementation of an embodiment of the invention as illustrated in <FIG>, inner sidewall surface <NUM> of cap <NUM> can include sections such as 2030A essentially between threads <NUM>, each section having an essentially the same slope with respect to the longitudinal axis A.

In an exemplary implementation, opening <NUM> to inner cavity <NUM> formed by inner sidewall surface <NUM> is essentially circular and has an opening diameter 2126A, which is larger than a flange diameter <NUM> of outer surface <NUM> of needless connector <NUM>, such that opening diameter 2126A causes a venting gap <NUM> between inner sidewall surface <NUM> and outer surface <NUM> of needless connector <NUM>.

Inner cavity <NUM> comprises threads <NUM> on inner sidewall surface <NUM> of sidewall <NUM> for engaging thread <NUM> of needleless connector <NUM>. In an exemplary implementation, at least a portion of threads <NUM> can include a protrusion 2140A to facilitate a more secure engagement with thread <NUM> of needless connector <NUM>.

In an exemplary implementation, inner cavity <NUM> comprises threads <NUM> on inner sidewall surface <NUM> of sidewall <NUM> which have a smaller profile than threads <NUM> and do not engage, for example in a friction fit manner, with thread <NUM> of needleless connector <NUM>. A removable cover <NUM> can be attached to bottom <NUM> of cap <NUM> to seal inner cavity <NUM> including disinfection sponge <NUM>.

In yet another exemplary implementation as illustrated in <FIG> and similar to an exemplary embodiment of <FIG>, cap <NUM> comprises ridges <NUM> formed on outer sidewall surface <NUM> of housing <NUM>, for example to facilitated better gripping of cap <NUM> such as when handling cap <NUM> to remove cover <NUM>, engage needleless connector <NUM>, and/or disengage needleless connector <NUM>.

<FIG> and <FIG> illustrate a disinfection cap <NUM> according an exemplary implementation of the embodiments of the present invention receiving a tip of needleless connector <NUM>, which is a female <NUM> % (Luer) lock conical fitting with external thread <NUM> configured according to International Standard, IS0594-<NUM>:<NUM>(E), as shown in annotated <FIG> where: a is angle of thread or lug bearing surface against separation with the plane perpendicular to the axis of lock fitting, which can be called in a non-limiting exemplary manner a connector thread a feature 133A; γ is minimum angle of external thread or lug non-bearing surface against separation with the plane perpendicular to the axis of the lock fitting; 2X is outside diameter across the lugs or external thread, which can be called in a non-limiting exemplary manner connector thread major feature 133B; E is minimum length of male lock fitting; G is maximum outside diameter of female lock fitting at base of lugs or maximum inside diameter of external thread; S is lug crest width or thread crest width of female lock fitting with lugs or external thread,; Y is maximum width of base of lug (axial) or thread at base, of female lock fitting to be measured at a point corresponding to an outside diameter equal to G.

Referring to cross-sectional view of <FIG> and three-dimensional view of <FIG>, disinfection cap <NUM> comprises housing <NUM> comprising: a closed top <NUM>; sidewall <NUM> with an outer sidewall surface <NUM>; and an open bottom <NUM> with an opening <NUM> to an inner cavity <NUM> within housing <NUM> for receiving needleless connector <NUM>. The inner cavity <NUM> can, but does not have to, accommodate an alcohol soaked disinfecting sponge <NUM>. As in the example of <FIG>, a removable cover such as <NUM> can be attached to bottom <NUM> of cap <NUM> to seal inner cavity <NUM> with, or without (as shown in <FIG>), a disinfection sponge <NUM> disposed therein.

Inner cavity <NUM> of cap <NUM> comprises one or more threads (protrusions, lugs, or ribs) <NUM>, <NUM> on inner sidewall surface <NUM> of its sidewall <NUM>. In an exemplary implementation, at least a portion of at least one thread, or entire thread, such as thread <NUM> can include a further protrusion (bump, lug, or rib) 3040A extending into cavity <NUM> from thread <NUM>. Protrusion 3040A engageably interfaces with at least a portion of thread <NUM> of connector <NUM>, for example a portion of connector thread a feature 133A and/or a portion of connector thread major feature 133B, to facilitate engagement of connector <NUM> within cavity <NUM> of cap <NUM>.

In an exemplary implementation, threads <NUM> on inner sidewall surface <NUM> of sidewall <NUM> have a smaller profile than threads <NUM> and do not engage, for example in a friction fit manner, with thread <NUM> of connector <NUM>. Threads <NUM> and <NUM> can be formed as a single continuous or partial thread with selectively formed features of thread <NUM> and/or <NUM> thereon, or as alternating continuous or partial threads for example at <NUM>-degrees, or at <NUM> degrees (as illustrated for example in <FIG>).

In another or additional exemplary implementation, thread or threads, such as threads <NUM>, which do not have further protrusions, can facilitate axial alignment of cap <NUM> with connector <NUM> when placing cap <NUM> onto connector <NUM>, or inserting connector <NUM> into cavity <NUM> of cap <NUM>, as illustrated for example in <FIG> and <FIG>. In an exemplary implementation, major profile of thread <NUM> within cavity <NUM> can correspond to, or match, essentially exactly or within a given tolerance thread major feature 133B of connector <NUM>. In other words, threads <NUM> interface with threads <NUM> essentially tangentially at the surface contact portions thereof. For example, in a cylindrical embodiment of cap <NUM>, threads <NUM> would meet threads <NUM> essentially at a contact diameter.

In an exemplary implementation where cap <NUM> and cavity <NUM> are essentially frustoconical with a larger cross section being at top <NUM>, as shown in the example of Figure 22A, engaging threads <NUM> can provide a more secure engagement of connector <NUM> as it advances into cavity <NUM>. Non-engaging threads <NUM> can provide interference fit, for example to facilitate further alignment or retention of connector <NUM> within cavity <NUM>.

In yet another or additional exemplary implementation, pitch and/or profile of threads <NUM> and/or <NUM> of the cap <NUM> do not correspond to pitch and/or profile of thread <NUM> of connector <NUM>. Accordingly, venting in cavity <NUM> of cap <NUM> occurs essentially around the outside of threads <NUM> when connector <NUM> is inside cavity <NUM>.

In still another or additional exemplary implementation, pitch of threads <NUM> corresponds to the pitch of thread <NUM> of connector <NUM>. However, the profile of threads <NUM> does not correspond to thread <NUM>. Since engaging threads <NUM> do not correspond to thread <NUM> venting in inner cavity <NUM> occurs essentially around the outside of threads <NUM> when connector <NUM> is inside the inner cavity <NUM>.

In yet another exemplary implementation as illustrated in Figure 22A and similar to an exemplary embodiment of <FIG> and <FIG>, cap <NUM> comprises ridges <NUM> formed on outer sidewall surface <NUM> of housing <NUM>, for example to facilitated better gripping of cap <NUM> such as when handling cap <NUM>, engaging connector <NUM> (into cavity <NUM>), and/or disengaging connector <NUM> (out of cavity <NUM>).

Referring to <FIG>, an exemplary implementation of embodiments of the present invention is described in terms of certain dimensional characteristics of various component of a disinfection cap <NUM>. Both relative and specific numerical characteristics presented in <FIG> are intended to facilitate a more complete understanding of exemplary implementations of embodiments of the present invention without limiting the scope of the invention as set forth in the claims. As in the example of <FIG>, a removable cover such as <NUM> can be attached to bottom <NUM> of cap <NUM> to seal inner cavity <NUM> with, or without (as shown in <FIG>), a disinfection sponge <NUM> disposed therein.

<FIG> shows three dimensional views of cap <NUM> from different perspectives: from an angle showing the top <NUM> of cap <NUM> (in the drawing on the left), and from an angle showing the bottom <NUM> of cap <NUM> (in the drawing on the right). <FIG> shows a side view of cap <NUM> illustrating a <NUM>-degree frustoconical configuration of body <NUM> of cap <NUM> according to an exemplary implementation of embodiments of the present invention. <FIG> is a view of cap <NUM> from top <NUM>. <FIG> is a view of cap <NUM> from bottom <NUM>, which also shows opening <NUM> to inner cavity <NUM>, threads <NUM>/<NUM>, and includes indications AC-AC, D-D, and E-E of cross sectional views of cap <NUM> illustrated in <FIG>, <FIG>, and <FIG> respectively. In an exemplary implementation, cap <NUM> can include divots <NUM> formed at bottom <NUM>, which are anti-rotational lugs used for injection molding when manufacturing cap <NUM>.

<FIG> is a cross sectional view AC-AC (see <FIG>) of cap <NUM> showing relative dimensional characteristics of cap body <NUM> including opening <NUM> and a thread pitch, as well as divots <NUM> (if formed at bottom <NUM> of cap <NUM>). <FIG> is a cross sectional view D-D (see <FIG>) of cap <NUM> also showing relative dimensional characteristics of cap body <NUM> including opening <NUM> and a thread pitch, as well as features of top <NUM> and detail B of thread <NUM>. <FIG> is a cross sectional view E-E (see <FIG>) of cap <NUM> further showing relative dimensional characteristics of cap body <NUM> including opening <NUM> and a thread pitch, as well as a frustoconical configuration of inner cavity <NUM>, a lip feature of bottom <NUM>, and detail A of thread <NUM>.

<FIG> is an enlarged cross sectional view B (see <FIG>) of specific relative dimensional characteristics of thread <NUM> according to an exemplary implementation of the embodiments of the present invention. <FIG> is an enlarged cross sectional view A (see <FIG>) of specific relative dimensional characteristics of thread <NUM> according to an exemplary implementation of the embodiments of the present invention. As shown in the examples of <FIG> and <FIG>, thread <NUM> and thread <NUM> can have substantially similar respective root section profiles 3040R and 3042R, and substantially different crest section profiles 3040C and 3042C.

Referring to <FIG> and <FIG>, a dispensing device <NUM> according to an exemplary embodiment of the present invention, includes a plurality of caps <NUM> disposed on a perforated strip <NUM>. In an exemplary implementation, perforations <NUM> are formed between caps <NUM> disposed on strip <NUM> to define portions <NUM> of strip <NUM> having at least one cap <NUM> disposed thereon. Caps <NUM> can be configured structurally and functionally like any of the caps illustrated in the examples of <FIG>, and <FIG> and described above with reference thereto. In an exemplary implementation, strip <NUM> can be a peel strip configured as a cap cover attached to bottom of each cap <NUM> to seal inner cavity of each cap <NUM>, for example as described above with reference to <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, 22A.

As illustrated in the example of <FIG>, each cap <NUM> can be peeled off or separated from strip <NUM> for immediate use, for example, to cap a needleless connector. On the other hand, as illustrated in the example of <FIG>, portion <NUM> including a cap <NUM> disposed thereon can be selectively separated from strip such that inner cavity of cap <NUM> remains sealed by the portion <NUM> similar to individual caps illustrated in the examples of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>.

According to exemplary embodiments of the present invention, dispensing device <NUM> can be configured to have a perforated strip <NUM> having a single row of caps <NUM>, as shown in <FIG> and <FIG>, or a perforated strip <NUM> having multiple rows of caps <NUM> separated by perforations <NUM>, as illustrated in the example of <FIG> showing a top view of such an implementation. According to yet another exemplary implementation as illustrated in a side view of <FIG>, dispensing device <NUM> can be configured to have a double-sided perforated peel strip <NUM> having two opposing sides <NUM> and <NUM>, and caps <NUM> attached at both sides thereof, such that two sealed caps <NUM> can be selectively detached from strip <NUM> at perforation <NUM> for later use (see Figure 22B) and/or individually removed from either side of strip <NUM> for immediate use (see Figure 22A).

As illustrated in <FIG>, <FIG>, <FIG>, strip <NUM>/<NUM>/<NUM> is essentially flat and has perforations in-between each cap <NUM>. Hence each perforated cap strip section can be torn off, or detached from, the main strip such that the cap <NUM> can be peeled opened for later use (see Figure 22B). Or, alternatively each cap can be peeled open from the cap strip for immediate use (see Figure 22A).

In exemplary implementations, strip <NUM>/<NUM>/<NUM> includes an attachment portion, such as an opening <NUM> at least at one end thereof, for example to accommodate a hanger of an IV pole such that device <NUM> can be hung on the IV pole for convenience. Other variations of an attachment portion, or means for selectively placing or hanging strip <NUM>/<NUM>/<NUM> on an IV pole, such as a hook or the like, can be integral with, or attached to, strip <NUM>/<NUM>/<NUM> as would be readily appreciated by one of ordinary skill in the art.

Referring to <FIG>, a dispensing device <NUM> according to an exemplary embodiment of the present invention, includes a plurality of caps <NUM> disposed on a hanging strip <NUM> which can be any shape, such as for example an injection molded runner bar including an attachment portion, such as top hook <NUM>, or other means for selectively placing or hanging the strip on an IV pole. Caps <NUM> can be configured structurally and functionally like any of the caps illustrated in the examples of <FIG>, and <FIG> and described above with reference thereto. According to an exemplary implementation, each cap <NUM> is sealed, for example, with a peel strip <NUM> similar to individual caps illustrated in the examples of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>.

In a further exemplary implementation, each cap <NUM> is attached to strip <NUM>, for example by prongs <NUM> attached to and extending away from the surface of the strip <NUM>. In an exemplary implementation, prongs <NUM> are configured as runner gate prongs that connect each cap <NUM> (for example, at exterior surface of a cap's top) with the strip <NUM> configured as main injection molded runner bar. As illustrated in the example of <FIG>, cap <NUM> torn away, or removed, from prong <NUM> has peel film <NUM> still adhered to the cap, so that it can be used at a later time.

In yet another exemplary implementation, as illustrated in the example of <FIG> dispensing device <NUM> can have multiple prongs <NUM> attached to strip <NUM> at diametrically opposite sides thereof such that, for example two caps <NUM> can be attached to strip <NUM> at essentially the same longitudinal location on strip <NUM>. Such a configuration can allow, for example, for twice as many caps attached to the same length strip.

While the present invention has been shown and described with reference to certain exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the embodiments of the present invention. For example, a disinfection sponge can comprise any suitable disinfecting or other application-specific substance, and can be made of any suitable material. Also, the cap can be single shot molded, or made by other suitable process.

In addition, the included drawing figures further describe non-limiting examples of implementations of certain exemplary embodiments of the present invention and aid in the description of technology associated therewith. Any specific or relative dimensions or measurements provided in the drawings other as noted above are exemplary and not intended to limit the scope or content of the inventive design or methodology as understood by artisans skilled in the relevant field of invention.

Claim 1:
A combination of a disinfecting cap and a secondary medical device connector, the combination comprising a multiple start thread pattern in the disinfecting cap having a closed top and a female thread to interface with the secondary medical device connector having a complimentary male thread, the multiple start thread pattern comprising:
a first start thread path (<NUM>, <NUM>) on the inner surface of a cylindrical wall forming a cavity of the disinfecting cap, wherein the first start thread path has a first major profile (<NUM>), a first minor profile (<NUM>), a first pitch, and a first thread section profile;
at least a second start thread path (<NUM>, <NUM>) on said inner surface, wherein the second start thread path has a second major profile, a second minor profile, a second pitch, and a second thread section profile;
wherein the first thread section profile and the second thread section profile are different, and
wherein the complimentary male thread (<NUM>, <NUM>) of the secondary medical device connector (<NUM>, <NUM>) has a third major profile (133B) with a uniform outer diameter, a third minor profile, and a third pitch substantially equivalent to said first pitch,
wherein
the first start thread path and the second start thread path form the female thread pattern,
the first and second start thread paths are configured to interface with said male thread,
the first start thread path interfaces with the complimentary male thread to substantially engage the complimentary male thread, and
when said first start thread path (<NUM>, <NUM>) engages said complimentary male thread (<NUM>, <NUM>) contacting said third major profile (133B), a first helical void is formed by the space enclosed by the first start thread path (<NUM>, <NUM>) and one of said third major profile (133B) and said third minor profile of the complimentary male thread (<NUM>, <NUM>) for venting of said inner cavity during engagement.