Sterile cap for iv needleless connector

Abstract

A disinfecting cap for an IV needle-free connector. A method for connecting first and second medical device connectors, the first connector comprising a first start thread path having a first major profile, a first minor profile, a first thread pitch, and a first thread cross-sectional profile, and a second start thread path, the first and second cross-sectional profiles being different, the second connector comprising a complementary male thread, the first and second start thread paths being configured to engage the complementary male thread, the method comprising engaging the complementary male thread by at least contacting the first start thread path with a third major profile, thereby forming a first helical void by means of a space encircled by at least one of the third major profile and a third minor profile of the complementary male thread and the first start thread path of the first medical device connector.

Description

[0001] Divisional

[0002] This patent application is a divisional patent application.

[0003] The original application of this divisional patent application is the patent application for "Disinfection Cap for IV Needleless Connector" with the filing date of January 18, 2017, the application number of 201710191020.5, and the invention name of "Disinfection Cap for IV Needleless Connector".

[0004] INTERACTION WITH RELATED APPLICATIONS

[0005] This application claims the benefit under 35 USC § 119(e) of U.S. Provisional Patent Application No. 62 / 279,986, filed January 18, 2016, and U.S. Provisional Patent Application No. 62 / 300,247, filed February 26, 2016, the contents of which (including all accompanying drawings) are incorporated herein by reference in their entirety. TECHNICAL FIELD

[0006] Generally, the exemplary embodiments of the present invention relate to the field of medical disinfection caps, and more particularly, to disinfection caps for use with IV needleless connectors. BACKGROUND

[0007] In order to reduce the cases of catheter related blood stream infections (CRBSI), which are high impact events with high costs and high associated mortality, the needleless connector disinfection cap space has been growing rapidly since the disinfection cap was first disclosed in U.S. Patent Publication No. 2007 / 011233, which was published as U.S. Patent No. 8,740,864, the entire contents of both of which are incorporated herein by reference, and introduced into the market. Disinfection caps such as those disclosed in U.S. Patent No. 8,740,864 have been used to reduce the number of CRBSI cases by providing a disinfection cap that is placed on the needleless connector hub prior to the needleless connector being connected to a catheter. The disinfection cap is then removed prior to the needleless connector being connected to the catheter. Figure 1A and 1B are illustrated, where the cap 1 includes a disinfection pad 2 and a cover 3, and the cap 4 includes a disinfection pad 5 and a cover 7, and also has threads 6 on its inner circumference 8 that interlock with the needleless connector hub. As illustrated in Figure 2 A plurality of disinfection caps 23, such as the cap 1 and / or the cap 7 in Figure 1A and 1B may be arranged on a strip 22 that includes openings 24 for hanging the strip 22 on an IV pole. On the IV pole hanging device 21, the strip 22 can serve as a common cover, for example, with the same function as the cover 3 and / or 7, for the caps 23 arranged thereon, so that the removed cap 25 is ready for immediate placement on the needleless connector.

[0008] Disinfection caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines, and early indications are that caps will also be included in the 2016 Infusion Nurses Standards (INS) guidelines.

[0009] In the developed markets, when an IV catheter is utilized, a needleless connector will typically be used to close the system and then opened to administer medication or other necessary fluids to the patient via the catheter. The INS practice standard recommends the use of a needleless connector and states that it should be "disinfected with alcohol, iodophor, or chlorhexidine gluconate / alcohol combination for duration and thoroughness before each access." The ultimate purpose of disinfecting the needleless connector is to help reduce the bacteria that can live on the surface and potentially cause various catheter related complications, including the CRBSI events described above. Nurses will typically accomplish this disinfection task by making what is known as a "hub swab" using a 70% IPA alcohol swab. However, compliance with this practice is typically very low. In addition to the lack of compliance with the "hub swab," it has also been noted through clinical observation that there is typically variation in the swabbing time, drying time, and the number of times the needleless connector is swabbed.

[0010] The cap technology presents significant challenges related to the needleless connector. All disinfection caps currently on the market contain 70% isopropyl alcohol as the active disinfecting ingredient. However, many needleless connector designs use acrylic or similar materials for the main housing. Acrylic has a mild to poor chemical resistance stability to isopropyl alcohol over long exposure times. As a result, isopropyl alcohol can cause chemical breakdown of the acrylic, which presents itself as discoloration and / or cracking of the needleless connector material. Additionally, almost all needleless connectors on the market use silicone materials for the fluid access valve design. Silicone materials have a mild to poor chemical resistance stability to isopropyl alcohol over long exposure times. This can cause the silicone components to swell, which can then cause the needleless connector valve to stick closed and / or not close at all (causing blood leaks). Additionally, the increased silicone swelling can increase the stress on the connector housing, which can exacerbate the cracking problem of the acrylic needleless connector housing.

[0011] Conventionally, to address the chemical compatibility of isopropyl alcohol with the needleless connector materials, disinfection caps with alcohol vents have been developed (such as those described in U.S. Patent Nos. 8,206,514; 7,985,302; and 7,780,794). These vents allow the cap to quickly vent disinfecting alcohol away from the needleless connector as compared to the caps currently on the market that do not have the vent. As a result, the alcohol vent can reduce the chemical damage to the needleless connector materials.

[0012] However, such conventional vent features have several significant drawbacks. One drawback is that the vent features can require complex vent holes formed in the cap, or assembly of two molded parts, a main cap housing and a threaded ring, based on effective undercut dominance, and / or assembly, as described, for example, in U.S. Patent No. 8,206,514. Such conventional vent features force cap designs to require separate molding of parts. These separate parts then need to be assembled, and subsequently welded or adhesively joined together. Thus, such designs inherently have higher processing costs, manufacturing complexity, and production costs, as compared to, for example, a single molded cap housing design.

[0013] Thus, if a disinfecting cap having a vent feature that avoids undercuts could be developed, the costly assembly and welding steps would be eliminated. Additionally, if a disinfecting cap having increased venting performance could be developed, needleless connector failures could be further reduced. SUMMARY

[0014] According to one aspect of the present invention, a disinfecting cap includes a housing including a closed top end, a generally cylindrical sidewall, and an open bottom formed by the sidewall having an opening to an internal cavity within the housing for receiving a tip of the needleless connector including a mating feature. A disinfecting sponge can be configured within the internal cavity having a removable cover that seals the opening to the internal cavity, thereby sealing the sponge within the internal cavity prior to use of the cap. The internal cavity includes at least one thread 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 not corresponding to the mating feature on the needleless connector.

[0015] According to another aspect of the present invention, at least one of a major diameter, a minor diameter, a pitch, a thread cross-sectional profile, and a number of threads of the cap thread does not correspond to the mating feature of the needleless connector.

[0016] According to another aspect of the present invention, a portion of the sidewall forming the open bottom includes an inner sidewall surface forming the opening to the internal cavity such that the open bottom does not form an air-tight seal with an outer surface of the needleless connector when the needleless connector is securely engaged with the housing.

[0017] According to another aspect of the present invention, the open bottom formed by the sidewall of the housing is not flat, such that there is an exit space between the bottom of the housing and a flat surface, whereby venting of the disinfecting sponge outside of the cap housing occurs substantially around the mating feature of the needleless connector outside and via the exit space through the opening to the internal cavity.

[0018] According to another aspect of the present application, the open bottom formed by the sidewall of the housing includes an irregular bottom interior sidewall surface having one or more undulations configured such that the opening to the interior cavity does not form an airtight seal with the outer surface of the needleless connector, whereby venting of the disinfectant sponge to the outside of the cap housing occurs through the opening to the interior cavity, substantially around the outside of the mating feature of the needleless connector, and via the at least one undulation.

[0019] According to another aspect of the present application, the housing includes a flared lower portion formed at the open bottom, the flared lower portion including one or more undulations regularly or randomly spaced along the bottom interior sidewall surface defining the opening to the interior cavity.

[0020] According to another aspect of the present application, the cap threads include an extension formed by the sidewall extending below the open bottom such that there is an escape space between the surface of the top of the needleless connector and the open bottom when the cap threads are interlocked with the needleless connector such that the extension contacts the top of the needleless connector, whereby venting of the disinfectant sponge to the outside of the cap housing occurs through the opening to the interior cavity, substantially around the outside of the mating feature of the needleless connector, and via the escape space.

[0021] According to another aspect of the present application, a portion of the sidewall forming the open bottom includes a flared bottom having an interior sidewall surface forming the opening to the interior cavity such that the open bottom does not form an airtight seal with the outer surface of the needleless connector when the needleless connector is securely engaged with the housing, whereby venting of the disinfectant sponge to the outside of the cap housing occurs through the opening to the interior cavity, substantially around the outside of the mating feature of the needleless connector, and between the interior wall surface of the flared bottom and the outer surface of the needleless connector.

[0022] According to another aspect of the present application, the open bottom formed by the sidewall of the housing is substantially flat.

[0023] According to another aspect of the present application, the open bottom formed by the sidewall of the housing is not flat such that there is an exit space between the bottom of the housing and a flat surface.

[0024] According to another aspect of the present application, the interior cavity includes an upper region terminating at a closed top end, and a lower region terminating at the opening to the interior cavity, the lower region including the cap threads, and the upper region including a protrusion to the interior cavity configured to contact and / or engage the sponge.

[0025] According to another aspect of the present application, the sidewall includes an interior sidewall surface including a plurality of portions between the cap threads, each portion having a slope with respect to a longitudinal axis of the cap housing. At least one of the portions forming the open bottom extends away from the longitudinal axis to form a flared open bottom.

[0026] According to another aspect of the present application, the inner cavity includes an upper region terminating at a closed top end, and a lower region terminating at an opening to the inner cavity. The inner sidewall surface includes a transition portion having a linear or curved surface, wherein the inner sidewall surface transitions from the lower region to the upper region such that a cross-sectional area at a bottom of the transition portion in the lower region is greater than a cross-sectional area at a top of the transition portion in the upper region.

[0027] According to another aspect of the present application, the sponge is secured to prevent displacement into the upper region when the cap threads interlock with the mating feature of the needleless connector, such that the sponge remains in contact with the needleless connector and remains distanced from the inner surface of the closed top end.

[0028] According to another aspect of the present application, the opening to the inner cavity formed by the inner sidewall surface of the bottom is substantially circular and includes an opening diameter, and the opening diameter is greater than a flange diameter of the needleless connector, such that the opening diameter causes a venting gap between the inner sidewall of the housing and the needleless connector, whereby the opening to the inner cavity includes the venting gap, and venting of the sterilizing sponge to the outside of the cap housing occurs through the opening to the inner cavity, substantially around the outside of the mating feature of the needleless connector, and via the venting gap.

[0029] According to another aspect of the present application, the sidewall includes an inner sidewall surface in the lower region, which includes a plurality of portions between the cap threads, each portion having substantially the same slope with respect to a longitudinal axis of the cap housing, and at least one portion forms the opening bottom, at least one portion extending away from the longitudinal axis forms a flared bottom.

[0030] According to another aspect of the present application, at least one cap thread on the inner sidewall surface of the sidewall includes a protrusion formed on at least a portion of the cap thread for facilitating interlocking with the mating feature of the needleless connector.

[0031] According to another aspect of the present application, at least a portion of at least one cap thread includes a non-engaging portion that does not engage with the mating feature of the needleless connector.

[0032] According to another aspect of the present application, the cap threads include at least one interlocking portion formed on at least a portion of the cap threads for facilitating interlocking with the mating feature of the needleless connector, and at least one non-engaging portion that does not engage with the mating feature of the needleless connector.

[0033] According to another aspect of the present application, an apparatus including a strip, and a plurality of sterilization caps according to some demonstrative embodiments of the present application disposed on the strip.

[0034] According to an exemplary implementation of the present application, the strip of the device is substantially flat and comprises a plurality of portions spaced apart by perforations in the strip, each portion comprising at least one of the plurality of sterilization caps arranged thereon, whereby the perforations facilitate separation of at least one of the sterilization caps arranged thereon at the perforations of the at least one portion.

[0035] According to another exemplary implementation of the present application, the strip comprises a detachable cover for the plurality of sterilization caps arranged thereon, whereby each cap of the plurality of caps is connected to the strip at a bottom of the cap, and peeling the strip exposes an opening to a lumen of the cap upon peeling of the strip.

[0036] According to yet another exemplary implementation of the present application, the strip is double-sided, comprising opposite sides, each side having a plurality of sterilization caps arranged thereon.

[0037] According to an alternative exemplary implementation of the present application, the strip comprises a plurality of prongs attached to and extending away from a surface of the strip, whereby each cap of the plurality of caps is removably attached to the strip by one of the prongs connected to an outer surface of a closed top end of the cap.

[0038] According to yet another exemplary implementation of the present application, the device comprises an attachment portion for selectively attaching the strip with the caps to an IV pole.

[0039] According to an exemplary implementation of the present application, a multi-start thread configuration for 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 cross-sectional profile; at least one second start thread path, wherein the second start thread path has a major profile, a minor profile, a pitch, and a second thread cross-sectional profile. The first thread cross-sectional profile and the second cross-sectional profile are different.

[0040] According to an exemplary implementation of the present application, the first start thread path and the second start thread path have equal pitches and are configured to connect with a complementary thread of a second medical device connector, the second medical device connector having a major profile and a pitch substantially the same as the pitch of the first start thread path and the second start thread path.

[0041] According to another exemplary implementation of the present application, upon engagement of the complementary thread with the first start thread path and the second start thread path, a first helical void is formed by a space enclosed by the complementary thread and the first start thread path, and a second helical void is formed by a space enclosed by the complementary thread and the second start thread path. The second helical void is larger than the first helical void.

[0042] According to yet another exemplary implementation of the present application, the first and second starting thread paths further comprise respective root cross-sectional profiles and respective crest cross-sectional profiles. The respective root cross-sectional profiles are substantially similar, while the respective crest cross-sectional profiles are substantially different.

[0043] According to yet another exemplary implementation of the present application, the first and second starting thread paths form a female thread configuration, and the complementary thread of the second medical device connector has a male thread configuration.

[0044] According to yet another exemplary implementation of the present application, the first and second starting thread paths form a male thread configuration, and the complementary thread of the second medical device connector has a female thread configuration.

[0045] According to yet another exemplary implementation of the present application, the second starting thread path connects with the complementary thread substantially tangentially.

[0046] According to yet another exemplary implementation of the present application, the first starting thread path connects with the complementary thread in a substantially intermeshing manner.

[0047] According to yet another exemplary implementation of the present application, the first and second starting thread paths have substantially equal thread pitches.

[0048] According to one exemplary implementation of the present application, a cap comprising a plurality of starting thread configurations comprises: an internal cavity; and an airflow path from a proximal end of the cap to the internal cavity formed by a first helical void and a second helical void upon intermeshing of a complementary thread with the plurality of starting thread configurations.

[0049] According to one exemplary implementation of the present application, the cap further comprises a disinfectant retaining member retained within the internal cavity at a substantially distal end of the cap.

[0050] According to another exemplary implementation of the present application, the cap further comprises an internal surface having the first and second starting thread paths and receiving the second medical device connector.

[0051] According to yet another exemplary implementation of the present application, the internal surface of the cap forms a substantially frustoconical internal cavity having a larger cross-sectional area at a proximal end of the cap.

[0052] According to yet another exemplary implementation of the present application, the internal surface of the cap forms a substantially cylindrical internal cavity having a larger cross-sectional area than a major diameter profile of the complementary thread of the second medical device connector.

[0053] The objects, advantages and features of the present application will become more apparent from the following detailed description of exemplary implementations of the present application, in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0054] The above benefits and other advantages of various embodiments of the present application will become more apparent with the following detailed description of illustrative embodiments thereof, when taken in conjunction with the accompanying drawings, in which:

[0055] Figure 1A and 1B is a cross-sectional view of a conventional type cap for a needleless connector.

[0056] Figure 2 is a schematic view of a conventional type device for hanging the cap on an IV pole.

[0057] Figure 3A and 3B is a three-dimensional view of a cap according to an illustrative embodiment of the present application.

[0058] Figure 4A is a cross-sectional view of a cap according to an illustrative embodiment of the present application.

[0059] Figure 4B illustrates another view of a cap according to an illustrative embodiment of the present application.

[0060] Figure 5 is a schematic view of a cap according to an illustrative embodiment of the present application when placed on a medical device such as a needleless connector.

[0061] Figure 6 is a schematic view illustrating a cross-sectional view of a cap according to an illustrative embodiment of the present application when placed on a medical device such as a needleless connector.

[0062] Figure 7 is a schematic view of air venting in a cap according to an illustrative embodiment of the present application when placed on a medical device such as a needleless connector.

[0063] Figure 8A is a cross-sectional view of a cap according to another illustrative embodiment of the present application.

[0064] Figure 8B illustrates another view of a cap according to another illustrative embodiment of the present application.

[0065] Figure 9 is a schematic view of air venting in a cap according to another illustrative embodiment of the present application when placed on a medical device such as a needleless connector.

[0066] Figure 10 is a schematic view illustrating a cross-sectional view of a cap according to another illustrative embodiment of the present application when placed on a medical device such as a needleless connector.

[0067] Figure 11Ais a cross-sectional view of a cap according to yet another exemplary embodiment of the present application.

[0068] Figure 11B is another view of a cap according to yet another exemplary embodiment of the present application.

[0069] Figure 12 is a schematic diagram showing a cross-sectional view of a cap according to yet another exemplary embodiment of the present application placed on a medical appliance such as a needleless connector.

[0070] Figure 13 is a schematic diagram showing a cross-sectional view of a cap according to yet another exemplary embodiment of the present application placed on a medical appliance such as a needleless connector.

[0071] Figure 14A is a schematic diagram showing venting in a cap according to yet another exemplary embodiment of the present application placed on a medical appliance such as a needleless connector.

[0072] Figure 14B is another view of a cap according to yet another exemplary embodiment of the present application.

[0073] Figure 15 is a three-dimensional view of a cap according to yet another exemplary embodiment of the present application.

[0074] Figure 16 is a schematic diagram showing a cross-sectional view of a cap according to yet another exemplary embodiment of the present application placed on a medical appliance such as a needleless connector.

[0075] Figure 17A is a cross-sectional view of a cap according to yet another exemplary embodiment of the present application.

[0076] Figure 17B is a schematic diagram showing a cross-sectional view of a cap according to yet another exemplary embodiment of the present application placed on a medical appliance such as a needleless connector.

[0077] Figure 17C is a schematic diagram showing venting in a cap according to yet another exemplary embodiment of the present application placed on a medical appliance such as a needleless connector.

[0078] Figure 18 is a cross-sectional view of a cap according to yet another exemplary embodiment of the present application.

[0079] Figure 19 is a cross-sectional view of a cap according to yet another exemplary embodiment of the present application.

[0080] Figure 20Ais a schematic diagram showing a cross-sectional view of a cap according to yet another illustrative embodiment of the application placed on a medical device such as a needleless connector.

[0081] Figure 20B is another view of a cap according to yet another illustrative embodiment of the application.

[0082] Figure 20C is a schematic diagram showing venting in a cap according to yet another illustrative embodiment of the application placed on a medical device such as a needleless connector.

[0083] Figure 21A is a schematic diagram showing a cross-sectional view of a cap according to yet another illustrative embodiment of the application placed on a medical device such as a needleless connector.

[0084] Figure 21B is another view of a cap according to yet another illustrative embodiment of the application.

[0085] Figure 21C is a schematic diagram showing venting in a cap according to yet another illustrative embodiment of the application placed on a medical device such as a needleless connector.

[0086] Figure 22 is a traditional female (luer) lock conical fitting.

[0087] Figure 23A is a cross-sectional view of a cap according to another illustrative embodiment of the application.

[0088] Figure 23B is a three-dimensional view of a cap according to another illustrative embodiment of the application.

[0089] Figure 24A , 24B , 24C, 24D, 24E, 24F, 24G, 24H, and 24I are engineering drawings of a cap according to some illustrative embodiments of the application in different perspective views, cross-sections, and magnified schematics of illustrative implementations.

[0090] Figure 25A and 25B illustrates an apparatus according to one illustrative embodiment of the application for hanging multiple caps on an IV pole.

[0091] Figure 25C illustrates an apparatus according to another illustrative embodiment of the application for hanging multiple caps on an IV pole.

[0092] Figure 25D illustrates an apparatus according to yet another illustrative embodiment of the application for hanging multiple caps on an IV pole.

[0093] Figure 26A An apparatus according to yet another illustrative embodiment of the present application for hanging multiple caps on an IV pole is illustrated.

[0094] Figure 26B An apparatus according to yet another illustrative embodiment of the present application for hanging multiple caps on an IV pole is illustrated.

[0095] Throughout the drawings, like reference numerals will be understood to refer to like parts, components, and structures. DETAILED DESCRIPTION

[0096] The subject matter exemplified in this specification is provided to aid in the overall understanding of illustrative embodiments of the present application. 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 and spirit of the application. Also, the description of known functionality and constructions has been omitted so as to not obscure the principles of the application.

[0097] Some illustrative embodiments of the present application provide a disinfecting cap that can have enhanced venting performance using novel single-molded cap design features in which disinfectant fluid venting can be achieved by incorporating cap features (major thread diameter, minor thread diameter, thread pitch, thread cross-sectional profile, and number of thread features) that do not correspond to matching features on an IV catheter needleless connector hub. The cap's minor thread diameter feature clamps the needleless connector major thread diameter feature, causing an interference friction fit between the two components. These non-corresponding thread features result in significant helical venting passages around the outside of the needleless connector major diameter portion between the cap and the IV hub. These passages draw alcohol soaked from the cap's upper portion, spiral down the cap's inner diameter, and vent to atmosphere from the cap's bottom.

[0098] As can be readily understood by those of ordinary skill in the relevant arts, in the following description, the definition of "features that do not correspond to matching features" is: features that are not identical in all elements or aspects to the matching features. The definition of "identical" is: outside the industry average tolerance range for injection molded plastic components and injection molded plastic component assemblies. Also, it should be noted that while descriptive terms such as "tip", "hub", "thread", "sponge", "protrusion", "slope", and others are used throughout this specification to enhance understanding, they are not intended to limit any components that can be used in combination or individually to achieve aspects of the embodiments of the present application.

[0099] Furthermore, the cap thread feature dimensions can be optimized with respect to the pinless connector thread or mating feature, thereby maximizing the cap's venting performance while still meeting other product requirements. Injection molding and demolding can be achieved through helical jetting or rotating cores of each component. Therefore, through the design concept of the exemplary embodiments of the present invention, secondary injection molding and / or plastic component assembly are not required.

[0100] Referring now to the accompanying drawings, wherein similar reference numerals indicate the same or corresponding parts in several drawings, various embodiments of the invention are described below.

[0101] Exemplary implementations of various embodiments of the present invention, such as Figure 3A , 3B As illustrated in 4-7, the cross-threaded sterilizing cap 300 can be fitted onto the tip or hub 12 of the pinless connector 9 and includes a housing 302 comprising: a closed tip 322; generally cylindrical sidewalls 304 having an outer sidewall surface 320; and an open bottom 324 having an opening 326 leading to an inner cavity 328 within the housing 302 for receiving the tip of the pinless connector 9. The bottom 324 formed by the sidewalls 304 of the housing 302 is not flat, resulting in a space 370 between the bottom 324 of the cap and the flat surface 310. The inner cavity 328 accommodates an alcohol-soaked sterilizing sponge 380 and has threads (or mating features) 340 on the inner sidewall surface 330 of the sidewall 304. The diameters (major diameter 345 and / or minor diameter 346) of the threads 340 of the cap 300 do not correspond to the threads (or mating features) 13 of the pinless connector 9. The removable cover 399 can be attached to the bottom 324 of the cap 300 to seal the inner cavity 328 including the sterilizing sponge 380.

[0102] In addition, such as Figure 6 and 7 As further illustrated, according to an exemplary implementation, the thread pitch, thread cross-sectional profile, and / or number of threads of the cap 300 do not correspond to the thread 13 of the pinless connector 9. Since the thread 340 of the cap 300 does not correspond to the thread 13 of the pinless connector 9, an vent 311 is generated to the outside of the cap housing 302 (atmosphere) via an opening 326 to the inner cavity 328, substantially around the outside of the thread 13 of the pinless connector 9, and via space 370, through an alcohol-impregnated sterile sponge 380.

[0103] Another exemplary implementation of the various embodiments of the present invention, such as Figures 8A-10As illustrated, the threaded, large-gap sterilizing cap 800 can be fitted onto the tip 12 of the pinless connector 9 and includes a housing 802 comprising: a closed tip 822; generally cylindrical sidewalls 804 having an outer sidewall surface 820; and an open bottom 824 having an opening 826 leading to an inner cavity 828 within the housing 802 for receiving the tip of the pinless connector 9. The bottom 824 formed by the sidewalls 804 of the housing 802 is not flat, resulting in a space 870 between the bottom 824 of the cap and the flat surface 810. The inner cavity 828 contains an alcohol-soaked sterilizing sponge 880 and has threads 840 on the inner sidewall surface 830 of the sidewall 804. A removable cover 899 can be attached to the bottom 824 of the cap 800 to seal the inner cavity 828 including the sterilizing sponge 880.

[0104] The pitch of thread 840 corresponds to the pitch of thread 13 of pinless connector 9. However, the profiles of thread 840 of cap 800 (large profile 841 and / or small profile 842) do not correspond to thread 13 of pinless connector 9. Since thread 840 of cap 800 does not correspond to thread 13 of pinless connector 9, venting occurs through an opening 826 to the inner cavity 828, substantially around the outside of thread 13 of pinless connector 9, and via space 870, to the outside (atmosphere) of cap housing 802 via an alcohol-impregnated sterile sponge 880.

[0105] Another exemplary implementation of the various embodiments of the present invention, such as Figure 11A , 11B As illustrated in 12, the threaded crenellated sterilization cap 1100 can be fitted onto the tip 12 of the pinless connector 9 and includes a housing 1102 comprising: a closed tip 1122; generally cylindrical sidewalls 1104 having an outer sidewall surface 1120; and an open bottom 1124 having an opening 1126 leading to an inner cavity 1128 within the housing 1102 for receiving the tip of the pinless connector 9. The bottom 1124 formed by the sidewalls 1104 of the housing 1102 includes an irregular inner sidewall surface 1132 with undulations, such that the opening 1126 does not form an airtight seal with the outer surface 25 of the pinless connector 9.

[0106] In one exemplary embodiment, the housing 1102 includes a flared lower portion 1190 formed at the bottom 1124, which includes undulations 1136. Any number, one or more undulations 1136 may be regularly or randomly spaced along the inner sidewall surface 1132 of the bottom. Figure 10 Similarly, in the example, the inner cavity 1128 contains an alcohol-soaked sterilizing sponge 1180 such that the sponge 1180 contacts and sterilizes at least the top 12 of the pinless connector 9. The inner cavity 1128 includes threads 1140 on the inner sidewall surface 1130 of the sidewall 1104.

[0107] The pitch of the threads 1140 corresponds to the pitch of the threads 13 of the needleless connector 9. However, the profile of the threads 1140 of the cap 1100 (major profile 1141 and / or minor profile 1142) does not correspond to the threads 13 of the needleless connector 9. Due to the threads 1140 of the cap 1100 not corresponding to the threads 13 of the needleless connector 9, substantially around the outside of the threads 13 of the needleless connector 9, and through the one or more undulations 1136 of the opening 1126 to the interior cavity 1128, venting 1111 of the alcohol impregnated disinfectant sponge 1180 to the outside of the cap housing 1102 (atmosphere) occurs. The bottom 1124 formed by the sidewall 1104 of the housing 1102 can be, but is not necessarily, substantially flat (as opposed to the illustrative embodiment of the cap 800 where there is a space 870 between the bottom 824 of the cap 800 and the flat surface 810). A removable cover 1199 can be connected to the bottom 1124 of the cap 1100 to seal the interior cavity 1128 including the disinfectant sponge 1180. Figure 10

[0108] According to yet another illustrative implementation of the embodiments of the present application, as Figure 13 14A and 14B, the extended thread design gap disinfectant cap 1300 can fit over the tip 12 of the needleless connector 9 and includes a housing 1302 comprising a closed top end 1322, a generally cylindrical sidewall 1304 having an outer sidewall surface 1320, and an open bottom 1324 having an opening 1326 to an interior cavity 1328 within the housing 1302 for receiving the tip of the needleless connector 9. The interior cavity 1328 includes an upper region 1312 and a lower region 1314 and contains an alcohol impregnated disinfectant sponge 1380. The lower region 1314 includes engagement threads 1340 on an inner sidewall surface 1330 of the sidewall 1304 for engaging the threads 13 of the needleless connector 9. The threads 1340 include an extension 1348 that extends below the bottom 1324 formed by the sidewall 1304 of the housing 1302 such that when the cap 1300 is installed on the connector 9 such that the extension 1348 contacts the top 25 of the needleless connector 9, there is a space 1370 between the surface 1310 of the top 25 of the needleless connector 9 and the bottom 1324 of the cap 1300.

[0109] ​​In one illustrative implementation, the upper region 1312 can include a protrusion 1355 from the inner sidewall surface 1330, and / or a protrusion 1357 from the top inner surface 1322, which engages or contacts the alcohol-impregnated disinfectant sponge 1380. The pitch of the engagement threads 1340 corresponds to the pitch of the threads 13 of the needleless connector 9. However, the profile of the engagement threads 1340 of the cap 1300 (large profile 1341 and / or small profile 1342) does not correspond to the threads 13 of the needleless connector 9. Because the threads 1340 of the cap 1300 do not correspond to the threads 13 of the needleless connector 9, air venting 1311 of the alcohol-impregnated disinfectant sponge 1380 to the outside of the cap housing 1302 (atmosphere) occurs through one of the openings 1326 into the lumen 1328, substantially around the outside of the threads 13 of the needleless connector 9, and via the space 1370. In one illustrative implementation, the bottom 1324 formed by the sidewall 1304 of the housing 1302 can be, but is not necessarily, substantially flat (as opposed to the illustrative implementation of the cap 800, where there is a space 870 between the bottom 824 of the cap 800 and the flat surface 810). A removable cover 1399 can be attached to the bottom 1324 of the cap 1300 to seal the lumen 1328 including the disinfectant sponge 1380. Figure 10

[0110] According to another illustrative implementation of the various embodiments of the present application, as shown in FIG. 15, a disinfectant cap 1500 can fit over the tip 12 of the needleless connector 9 and include a housing 1502 comprising: a closed top end 1522; a generally cylindrical sidewall 1504 having an outer sidewall surface 1520; and an open bottom 1524 having an opening 1526 into a lumen 1528 within the housing 1502 for receiving the tip of the needleless connector 9. The lumen 1528 includes an upper region 1512 and a lower region 1514 and contains an alcohol-impregnated disinfectant sponge 1580. The bottom 1524 formed by the sidewall 1504 of the housing 1502 includes a flared bottom 1590 having an inner sidewall surface 1532 such that the opening 1526 does not form an air-tight seal with the outer surface 25 of the needleless connector 9 when the tip of the connector 9 is securely engaged within the lower region 1514 of the lumen 1528. A removable cover 1599 can be attached to the bottom 1524 of the cap 1500 to seal the lumen 1528 including the disinfectant sponge 1580. Figures 15-19

[0111] In one illustrative implementation, the opening 1526 into the lumen 1528 formed by the inner sidewall surface 1532 is substantially circular and has an opening diameter 26 that is greater than the flange diameter 1533 of the outer surface 25 of the needleless connector 9, such that the opening diameter 26 creates an air venting gap 1527 between the inner sidewall surface 1532 and the outer surface 25 of the needleless connector 9. In one illustrative implementation, the opening 1526 into the lumen 1528 formed by the inner sidewall surface 1532 is substantially circular and has an opening diameter 26 that is greater than the flange diameter 1533 of the outer surface 25 of the needleless connector 9, such that the opening diameter 26 creates an air venting gap 1527 between the inner sidewall surface 1532 and the outer surface 25 of the needleless connector 9.​

[0112] The lower region 1514 includes threads 1540 on the inner sidewall surface 1530 of the sidewall 1504 for engaging threads 13 of the pinless connector 9. In one exemplary implementation, the upper region 1512 may include protrusions 1555 on the inner sidewall surface 1530 and / or protrusions (not shown) on the top inner surface 1522 (such as... Figure 13 The example illustrates protrusion 1357, which engages with or contacts the disinfectant sponge 1580.

[0113] The pitch of thread 1540 corresponds to the pitch of thread 13 of pinless connector 9. However, the profiles (large profile 1541 and / or small profile 1542) of the engaging thread 1540 of cap 1500 do not correspond to thread 13 of pinless connector 9. Since the engaging thread 1540 of cap 1500 does not correspond to thread 13 of pinless connector 9, venting 1511 occurs substantially around the outside of thread 13 of pinless connector 9 and through opening 1526 into inner cavity 1528, from alcohol-impregnated sterile sponge 1580 to the outside (atmosphere) of cap housing 1502. In one exemplary implementation, venting 1511 through opening 1526 occurs via vent gap 1527.

[0114] The bottom 1524 formed by the sidewalls 1504 of the housing 1502 may, but is not required to, be substantially flat (with...). Figure 10 In contrast to the exemplary embodiment, a space 870 exists between the bottom 824 of the cap 800 and the flat surface 810.

[0115] An exemplary implementation of an embodiment of the present invention, such as Figure 17A , 17B As illustrated in 17C, the inner sidewall surface 1530 in the lower region 1514 of the cap 1500 may include segments 1530C, 1530D, 1530E, and 1530F substantially between the threads 1540, each segment having a slope about the longitudinal axis A. In another exemplary embodiment, the inner sidewall 1530 on the segments 1530E and 1530F sides extends away from the longitudinal axis A, forming an outwardly flared flared opening 1526. In yet another exemplary implementation, the inner cross-sectional area at the top of segment 1530C may be smaller than the cross-sectional area at the bottom of segment 1530F, forming opening 1526. In yet another exemplary implementation, the cross-sectional area at the top of segment 1530D may be configured to prevent the pinless connector 9 from being further inserted into the cavity 1528, such that the tip 12 of the pinless connector 9 substantially stops at the top of segment 1530D, as... Figure 16 As shown in the example.

[0116] In yet another illustrative implementation, the inner sidewall surface 1530 in the upper region 1512 of the cap 1500 can include segments 1530AA and 1530A substantially between the protrusions 1555, each having a slope with respect to the longitudinal axis A. In still other illustrative implementations, the inner sidewall surface 1530 can include a transition segment 1530B having a linear (see Figure 19 , or curved (see Figure 17A , 17B , 17C and 18) surface at the transition of the inner sidewall surface 1530 from the lower region 1514 to the upper region 1512, such that the cross-sectional area at the bottom of the segment 1530B in the region 1514 is greater than the cross-sectional area at the top of the segment 1530B in the region 1512. The protrusions 1555 and / or the smaller cross-sectional area at the top of the segment 1530 can prevent displacement of the sponge 1580 into the upper region 1512 when the cap 1500 engages the needleless connector 9, such that the sponge 1580 can be compressed and / or held within a certain region of the inner cavity 1528 of the cap 1500 (e.g., substantially within the segments 1530B and 1530C) when the tip 12 of the connector 9 is secured within the inner cavity 1528 of the cap 1500.

[0117] In still another illustrative implementation of the embodiments of the present application, the inner sidewall surface 1530 of the lower region 1514 of the cap 1500 can include segments 1530C, 1530D, and 1530E substantially between the threads 1540, and a segment 1530F as the bottommost segment or having a bore diameter step below the segment 1530F, as illustrated in Figure 18 . All of the segments have substantially the same slope or angle with respect to the longitudinal axis A. However, unlike the illustrative implementation illustrated in Figure 19 , the segments 1530C, 1530D, 1530E, and / or 1530F are not collinear.

[0118] In still another illustrative implementation of the embodiments of the present application, the inner sidewall surface 1530 of the lower region 1514 of the cap 1500 can include segments 1530C, 1530D, and 1530E substantially collinear 1531 substantially between the threads 1540, all of the segments having substantially the same slope or angle with respect to the longitudinal axis A, as illustrated in Figure 19 . However, unlike the illustrative implementation illustrated in Figure 18 , the segment 1530F can be configured as an integral bottommost segment of the segment 1530E.

[0119] In yet another illustrative implementation, the cap 1500 includes a ridge 1598 formed on the outer sidewall surface 1520 of the housing 1502, for example, to facilitate better gripping of the cap 1500, such as when manipulating the cap 1500 to remove the cover 1599, engage the needleless connector 9, and / or disengage the needleless connector 9.

[0120] According to further illustrative implementations of the present application, as Figure 20A 、 20B As illustrated in FIGS. 20A and 20C, the disinfecting cap 2000 can fit over the tip 12 of the needleless connector 9 and include a housing 2002 that includes a closed top end 2022, a sidewall 2004 having an outer sidewall surface 2020, and an open bottom 2024 having an opening 2026 to an inner cavity 2028 within the housing 2002 for receiving the tip of the needleless connector 9. The inner cavity 2028 contains an alcohol-impregnated disinfecting sponge 2080. The bottom 2024 formed by the sidewall 2004 of the housing 2002 includes a bottom 2090 having an inner sidewall surface 2032 such that the opening 2026 does not form an air-tight seal with the outer surface 25 of the needleless connector 9 when the tip of the connector 9 is securely engaged within the inner cavity 2028. As with the example in FIGS. 15A and 15B, a removable cover such as 1599 can be connected to the bottom 2024 of the cap 2000 to seal the inner cavity 2028 containing the disinfecting sponge 2080. Figure 15

[0121] In one illustrative implementation, the opening 2026 to the inner cavity 2028 formed by the inner sidewall surface 2032 is substantially circular and has an opening diameter 2026A that is greater than the flange diameter 2033 of the outer surface 25 of the needleless connector 9, such that the opening diameter 2026A creates an air gap 2027 between the inner sidewall surface 2032 and the outer surface 25 of the needleless connector 9.

[0122] The inner cavity 2028 includes threads 2040 on the inner sidewall surface 2030 of the sidewall 2004 for engaging the threads 13 of the needleless connector 9. In one illustrative implementation, at least a portion of the threads 2040 can include a protrusion 2040A to facilitate a more secure engagement with the threads 13 of the needleless connector 9.

[0123] ​The pitch of the threads 2040 corresponds to the pitch of the threads 13 of the needleless connector 9. However, the profile of the threads 2040 of the cap 2000 (major profile 2041 and / or minor profile 2042) does not correspond to the threads 13 of the needleless connector 9. Because the threads 2040 of the cap 2000 do not correspond to the threads 13 of the needleless connector 9, substantially around the outside of the threads 13 of the needleless connector 9, and through the opening 2026 to the interior cavity 2028, venting 2011 of the alcohol impregnated sterilization sponge 2080 to the outside of the cap housing 2002 (atmosphere) occurs. In one illustrative implementation, the venting 2011 occurs through the opening 2026 via the venting gap 2027. A removable cover 2099 can be attached to the bottom 2024 of the cap 2000 to seal the interior cavity 2028 including the sterilization sponge 2080.

[0124] In one illustrative implementation of an embodiment of the present application, as Figure 20A schematically shown in FIGS. 21A and 21B, the inside wall surface 2132 of the bottom 2190 of the cap 2100 can include segments such as 2130A substantially between each thread 2040, each segment having substantially the same slope or angle with respect to the longitudinal axis A.

[0125] In accordance with yet another illustrative implementation of an embodiment of the present application, as Figure 21A , 21B and 21C, the sterilization cap 2100 can fit over the tip 12 of the needleless connector 9 and include a housing 2102 including: a closed top end 2122; a sidewall 2104 having an outside wall surface 2120; and an open bottom 2124 having an opening 2126 to an interior cavity 2128 within the housing 2102 for receiving the tip of the needleless connector 9. The interior cavity 2128 contains an alcohol impregnated sterilization sponge 2180. The bottom 2124 formed by the sidewall 2104 of the housing 2102 includes a bottom 2190 having an inside wall surface 2132 such that when the tip of the connector 9 is securely engaged within the interior cavity 2128, the opening 2126 does not form an air tight seal with the outer surface 25 of the needleless connector 9. As with the example in Figure 15 , a removable cover such as 1599 can be attached to the bottom 2124 of the cap 2100 to seal the interior cavity 2128 including the sterilization sponge 2180.

[0126] In one illustrative implementation, the opening 2126 to the interior cavity 2128 formed by the inside wall surface 2132 is substantially circular and has an opening diameter 2126A that is greater than the flange diameter 2133 of the outer surface 25 of the needleless connector 9, such that the opening diameter 2126A creates a venting gap 2127 between the inside wall surface 2132 and the outer surface 25 of the needleless connector 9.

[0127] The interior cavity 2128 includes threads 2140 on the interior sidewall surface 2130 of the sidewall 2104 for engaging the threads 13 of the needleless connector 9. In one illustrative implementation, at least a portion of the threads 2140 can include protrusions 2140A to facilitate a more secure engagement with the threads 13 of the needleless connector 9.

[0128] The pitch of the threads 2140 corresponds to the pitch of the threads 13 of the needleless connector 9. However, the profile of the threads 2140 (major profile 2141 and / or minor profile 2142) of the cap 2100 does not correspond to the threads 13 of the needleless connector 9. As a result of the threads 2140 of the cap 2100 not corresponding to the threads 13 of the needleless connector 9, substantially around the exterior of the threads 13 of the needleless connector 9, and through the opening 2126 to the interior cavity 2128, venting 2111 of the alcohol-impregnated disinfectant sponge 2180 to the exterior of the cap housing 2102 (atmosphere) occurs. In one illustrative implementation, the venting 2111 occurs through the opening 2126 via the venting gap 2127.

[0129] In one illustrative implementation, the interior cavity 2128 includes threads 2143 on the interior sidewall surface 2130 of the sidewall 2104 having a minor profile than the threads 2140 and not engaging the threads 13 of the needleless connector 9, for example, in a friction fit. A removable cover 2199 can be connected to the bottom 2124 of the cap 2100 to seal the interior cavity 2128 including the disinfectant sponge 2180.

[0130] In yet another illustrative implementation, as shown in Figure 21C and similar to the illustrative implementation of the cap 100 of Figure 17C The cap 2100 includes a ridge 2198 formed on the exterior sidewall surface 2120 of the housing 2102, for example, to facilitate better gripping of the cap 2100, such as when manipulating the cap 2100 to remove the cover 1599, engage the needleless connector 9, and / or disengage the needleless connector 9.

[0131] Figure 23A and 23B A disinfectant cap 3000 according to one illustrative implementation of embodiments of the present application is shown for receiving a top end of a needleless connector 93 having a female 6% (Luer) lock taper, the outer threads 113 configured according to International Standard ISO 594-2:1998(E), as annotated in Figure 22wherein: a is the angle of the thread or anti-decoupling bead bearing surface to the plane perpendicular to the axis of the lock joint, which can be referred to in non-limiting illustrative fashion as the connector thread a feature 133 A; g is the minimum angle of the outer thread or anti-decoupling bead non-bearing surface to the plane perpendicular to the axis of the lock joint; 2X is the outer diameter across the bead or outer thread, which can be referred to in non-limiting illustrative fashion as the connector thread major diameter feature 133B; E is the minimum length of the male luer; G is the maximum outer diameter of the female luer at the base of the bead or at the maximum inner diameter of the outer thread; S is the bead or thread top width of the female luer mated with the bead or outer thread; and Y is the maximum width of the bead (axial) base or base thread of the female luer measured at a point corresponding to the outer diameter equal to G.

[0132] Referring to Figure 23A the cross-sectional view and Figure 23B the three-dimensional view, the disinfecting cap 3000 includes a housing 3002 including a closed top end 3022, a sidewall 3004 having an outer sidewall surface 3020, and an open bottom 3024 having an opening 3026 to an inner cavity 3028 within the housing 3002 for receiving the top end of the needleless connector 93. The inner cavity 3028 can, but need not, contain an alcohol impregnated disinfecting sponge 3080. As with the example in Figure 15 a removable cover such as 1599 can be connected to the bottom 3024 of the cap 3000 to seal the inner cavity 3028 with or without (as shown in Figure 23B ) the disinfecting sponge 3080 disposed therein.

[0133] The inner cavity 3028 of the cap 3000 includes one or more threads (protrusions, beads, or ridges) 3040, 3042 on the inner sidewall surface 3030 of the sidewall 3004. In one illustrative implementation, at least a portion of, or the entire, thread such as thread 3040 can include further protrusions (bumps, beads, or ridges) 3040A extending from the thread 3040 into the inner cavity 3028. The protrusions 3040A are engageably contactable with at least a portion of the threads 133 of the connector 93 such as the connector thread a feature 133 A and / or the connector thread major diameter feature 133B to facilitate engagement of the connector 93 within the inner cavity 3028 of the cap 3000.

[0134] In one illustrative implementation, the threads 3042 on the inner sidewall surface 3030 of the sidewall 3004 have a smaller profile than the threads 3040 and do not engage the threads 133 of the connector 93 in, for example, a friction fit. The threads 3040 and 3042 can be formed as a single continuous or partial thread on which the thread 3040 and / or 3042 features are selectively formed, or as, for example, at 180 degrees, or at 90 degrees (as shown inFigures 24A-24I alternating continuous or partial threads.

[0135] In another or further illustrative implementation, one or more threads, such as threads 3042, which do not have other protrusions, can facilitate axial alignment of the cap 3000 with the connector 93 when the cap 3000 is placed on the connector 93, or the connector 93 is inserted into the inner cavity 3028 of the cap 3000, as illustrated, for example, in Figure 23A and 23B In one illustrative implementation, the major diameter profile of the threads 3040 within the inner cavity 3028 can substantially exactly, or within a given tolerance, correspond to, or match, the threaded major diameter feature 133B of the connector 93. In other words, the threads 3042 substantially tangentially contact the threads 133 at their surface contact portions. For example, in a cylindrical embodiment of the cap 3000, the threads 3042 will contact the threads 133 at a substantially contacting diameter.

[0136] In one illustrative implementation, where the cap 3000 and the inner cavity 3028 are substantially frustoconical with a larger cross section at the top 3022, as illustrated in the example of Figure 23A As the connector 93 is advanced into the inner cavity 3028, the engaged threads 3040 can provide a more secure engagement of the connector 93. The non-engaged threads 3042 can provide, for example, an interference fit to facilitate further alignment or retention of the connector 93 within the inner cavity 3028.

[0137] In yet another or further illustrative implementation, the pitch and / or profile of the threads 3040 and / or 3042 of the cap 3000 do not correspond to the pitch and / or profile of the threads 133 of the connector 93. As a result, venting within the inner cavity 3028 of the cap 3000 occurs substantially around the outside of the threads 133 when the connector 93 is inside the inner cavity 3028.

[0138] In yet another or further illustrative implementation, the pitch of the threads 3040 corresponds to the pitch of the threads 133 of the connector 93. However, the profile of the threads 3040 does not correspond to the profile of the threads 133. As a result of the engaged threads 3040 not corresponding to the threads 133, venting within the inner cavity 3028 occurs substantially around the outside of the threads 133 when the connector 93 is inside the inner cavity 3028.

[0139] In yet another illustrative implementation, as illustrated in Figure 24A and in conjunction with Figure 17C and 21BThe exemplary embodiment of the cap 3000 includes a ridge 3098 formed on the outer sidewall surface 3020 of the housing 3002, for example, to facilitate better gripping of the cap 3000, such as when manipulating the cap 3000, engaging the connector 93 (into the internal cavity 3028), and / or disengaging the connector 94 (out of the internal cavity 3028).

[0140] Referring to Figures 24A-24I , one exemplary implementation of the embodiments of the present application is described in terms of certain dimensional features of the various components of the sterilization cap 3000. Figures 24A-24I The relative and specific numerical features presented in the Figure 15 , as in the example of FIG. 24H, a removable cover such as 1599 can be attached to the bottom 3024 of the cap 3000 to seal the internal cavity 3028 with or without (as shown in FIG. 24H) the sterilization sponge 3080 disposed therein. Figures 24A-24I

[0141] Figure 24A Three-dimensional views of the cap 3000 from different angles are shown: from an angle showing the top 3022 of the cap 3000 (on the left side of the figure), and from an angle showing the bottom 3024 of the cap 3000 (on the right side of the figure). Figure 24B A side view of the cap 3000 is shown, illustrating the 6-degree truncated cone configuration of the body 3002 of the cap 3000 according to the exemplary implementation of the embodiments of the present application. Figure 24C is a view of the cap 3000 from the top 3022. Figure 24D is a view of the cap 3000 from the bottom 3024, which also shows the opening 3026 to the internal cavity 3028, the threads 3040 / 3042, and includes the Figure 24E , 24F , and 24H. In one exemplary implementation, the cap 3000 can include several undulations 2499 formed at the bottom 3024, which are anti-rotation protrusions for injection molding when manufacturing the cap 3000.

[0142] Figure 24E is a cross-sectional view AC-AC (see Figure 24D ) of the cap 3000, which shows the relative dimensional features of the cap body 3002, including the opening 3026 and the thread pitch, as well as the undulations 2499 (if formed at the bottom 3024 of the cap 3000). Figure 24F is a cross-sectional view D-D (see Figure 24D ​, which also shows relative dimensional features of the cap body 3002, including the opening 3026 and the thread pitch, as well as details of the top 3022 and the thread 3040. Figure 24H is a cross-sectional view E-E (see Figure 24D ) of the cap 3000, which also shows relative dimensional features of the cap body 3002, including the opening 3026 and the thread pitch, as well as details of the inner cavity 3028, the rim feature of the bottom 3024, and the thread 3042.

[0143] Figure 24G is an enlarged cross-sectional view B (see Figure 24F ) of certain relative dimensional features of the thread 3040 according to an illustrative embodiment of the present application. Figure 24I is an enlarged cross-sectional view A (see Figure 24H ) of certain relative dimensional features of the thread 3042 according to an illustrative embodiment of the present application. As shown by the examples in Figure 24G and 24I , the thread 3040 and the thread 3042 can have substantially similar respective root profiles 3040R and 3042R, and substantially different top profiles 3040C and 3042C.

[0144] Referring to Figure 25A and 25B , a dispensing device 2260 according to an illustrative embodiment of the present application includes a plurality of caps 2230 arranged on a perforated strip 2220. In an illustrative embodiment, perforations 2270 are formed between the caps 2230 arranged on the strip 2220 to define portions 2272 of the strip 2220 having at least one cap 2230 arranged thereon. The caps 2230 can be configured to be structurally and functionally similar to any of the caps schematically illustrated in the examples of Figure 1A , 1B , and 3A through 21C and described above with reference thereto. In an illustrative implementation, the strip 2220 can be a peel strip configured to have a cap cover connected to the bottom of each cap 2230 to seal an inner cavity of each cap 2230, such as described above with reference to Figure 1A , 1B , 4B, 8B, 1 IB, 14B, 15, 20B, 21B, 25A.

[0145] As schematically illustrated in the examples of Figure 25A , each cap 2230 can be peeled or separated from the strip 2220 for immediate use, such as to cap a needleless connector. On the other hand, as schematically illustrated in the examples of Figure 25BAs illustrated in the examples of FIGS. 22A, 22B, 22C, and 22D, the portion 2272 of the cap 2230 disposed thereon can be selectively detached from the strip such that the inner cavity of the cap 2230 remains sealed by the portion 2272, similar to the examples of FIGS. 21A, 21B, 21C, and 21D. Figure 1A , 1B , 4B, 8B, 11B, 14B, 15, 20B, and 21B.

[0146] According to exemplary embodiments of the present application, the dispensing device 2260 can be configured with a perforated strip 2220 having a single row of caps 2230, as illustrated in the examples of FIGS. 22A, 22B, 22C, and 22D, or a perforated strip 2250 having multiple rows of caps 2230 spaced by perforations 2273, as illustrated in the examples of FIGS. 23A, 23B, 23C, and 23D. Figure 25A and 25B . According to yet another exemplary embodiment, as illustrated in the top view of FIG. 24, the dispensing device 2260 can be configured with a double-sided perforated peel strip 2255 having two opposite sides 2265 and 2267, and caps 2230 attached to both sides thereof, such that two sealed caps 2230 can be selectively detached from the strip 2255 for later use (see FIG. 25A) and / or removed individually from each side of the strip 2255 for immediate use (see FIG. 25B). Figure 25C Figure 25D As illustrated in the examples of FIGS. 22A, 22B, 22C, and 22D, the portion 2272 of the cap 2230 disposed thereon can be selectively detached from the strip such that the inner cavity of the cap 2230 remains sealed by the portion 2272, similar to the examples of FIGS. 21A, 21B, 21C, and 21D. Figure 25D Figure 25D As illustrated in the examples of FIGS. 22A, 22B, 22C, and 22D, the portion 2272 of the cap 2230 disposed thereon can be selectively detached from the strip such that the inner cavity of the cap 2230 remains sealed by the portion 2272, similar to the examples of FIGS. 21A, 21B, 21C, and 21D.

[0147] As illustrated in the examples of FIGS. 22A, 22B, 22C, and 22D, the portion 2272 of the cap 2230 disposed thereon can be selectively detached from the strip such that the inner cavity of the cap 2230 remains sealed by the portion 2272, similar to the examples of FIGS. 21A, 21B, 21C, and 21D. Figure 25A , 25B , 25C, and 25D, the strip 2220 / 2250 / 2255 is substantially flat and has perforations between each cap 2230. Thus each perforated cap strip segment can be torn off, or detached, from the main strip, such that the cap 2230 can be peeled off for later use (see FIG. 26A). Or alternatively, each cap can be peeled off from the cap strip for immediate use (see FIG. 26B). Figure 25B Figure 25A As illustrated in the examples of FIGS. 22A, 22B, 22C, and 22D, the portion 2272 of the cap 2230 disposed thereon can be selectively detached from the strip such that the inner cavity of the cap 2230 remains sealed by the portion 2272, similar to the examples of FIGS. 21A, 21B, 21C, and 21D.

[0148] In some exemplary embodiments, the strip 2220 / 2250 / 2255 includes an attachment portion, such as an opening 2240 at least at one end thereof, for example, to accommodate a hook of an IV pole, such that the device 2260 can be hung on the IV pole for convenience. Other variations of the attachment portion, or means for selectively placing or hanging the strip 2220 / 2250 / 2255 on an IV pole, such as a hook or the like, can be integrated with, or attached to, the strip 2220 / 2250 / 2255, as would be readily appreciated by one of ordinary skill in the art.

[0149] Referring to FIGS. 22A, 22B, 22C, and 22D, and FIGS. 23A, 23B, 23C, and 23D Figure 26A and 26B ​​​According to an exemplary embodiment of the present application, the dispensing apparatus 2360 includes a plurality of caps 2330 arranged on a hanging strip 2320, such as, for example, an injection molded runner strip including attachment portions, such as top hooks 2340, or other means for selectively placing or hanging the strip on an IV pole. The caps 2330 can be configured to be structurally and functionally similar to any of the caps illustrated in the examples of FIGS. 3A through 21C and described above with reference thereto. According to an exemplary embodiment, each cap 2330 is sealed, for example, with a peel strip 2372, similar to the individual caps illustrated in the examples of FIGS. Figure 1A , 1B , 4B, 8B, 11B, 14B, 15, 20B, and 21B. Figure 1A , 1B

[0150] In another exemplary embodiment, each cap 2330 is attached to the strip 2372, for example, by a fork 2380 attached to a surface of the strip 2372 and extending away from the surface of the strip 2372. In an exemplary embodiment, the fork 2380 is configured as a runner gate fork root that connects each cap 2330 (e.g., at an outer surface of a top of the cap) to the strip 2372 configured as a main injection molded runner strip. As illustrated in the example of FIG. 23B, a cap 2330 that is torn or removed from the fork 2380 has the peel film 2372 still attached to the cap so that it can be used later. Figure 26A

[0151] In yet another exemplary embodiment, as illustrated in the example of FIG. 23C, the dispensing apparatus 2360 can have a plurality of forks 2380 attached to the strip 2372 on opposite sides in diameter, so that, for example, two caps 2380 can be attached to the strip 2372 at substantially the same longitudinal position on the strip 2372. Such a configuration can, for example, allow twice the number of caps to be attached to the same length of strip. Figure 26B

[0152] While the application 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 can be made therein without departing from the spirit and scope of the embodiments of the application. For example, the disinfecting sponge can include any suitable disinfecting or other specialty material, and can be made of any suitable material. Also, the caps can be single molded, or can be made by other suitable processes.

[0153] ​​​In addition, the included drawings describe and demonstrate certain illustrative embodiments of the present application and aid in the understanding of the technology thereof. Any particular or relative

[0154] The objectives, advantages, and features of the present application will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings in which:

[0154] The objectives, advantages, and features of the present application will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings in which:

Claims

1. A method for connecting a first medical device connector and a second medical device connector, wherein the first medical device connector comprises a first start thread path having a first major profile, a first minor profile, a first pitch, and a first thread cross-sectional profile; and at least one second start thread path having a second major profile, a second minor profile, a second pitch, and a second thread cross-sectional profile; the first thread cross-sectional profile and the second thread cross-sectional profile are different, and the first start thread path and the second start thread path form a female thread configuration, the second medical device connector comprises a complementary male thread having a third major profile and a third pitch substantially equal to the first or second pitch, and the first and second start thread paths are configured to engage with the complementary male thread, the method comprises: meshing the complementary male thread of the second medical device connector by contacting at least the first start thread path with the third major profile, thereby forming a first helical void by means of a space encircled by the first start thread path of the first medical device connector and the complementary male thread of the second medical device connector.

2. The method of claim 1, further comprising forming a second helical void by means of a space encircled by the second start thread path of the first medical device connector and the complementary male thread of the second medical device connector, the second helical void being larger than the first helical void.

3. The method of claim 1, wherein the first pitch is substantially equal to the second pitch.

4. The method of claim 1, wherein the first and second start thread paths further comprise respective root cross-sectional profiles and respective crown cross-sectional profiles, wherein the respective root cross-sectional profiles are substantially similar and the respective crown cross-sectional profiles are substantially different.

5. The method of claim 1, wherein the second start thread path substantially tangentially engages the complementary male thread.

6. The method of claim 1, wherein the first start thread path engages the complementary male thread to substantially mesh the complementary male thread.

7. A method of capping a medical device connector, wherein the cap comprises a first start thread path having a first major profile, a first minor profile, a first pitch, and a first thread cross-sectional profile, at least one second start thread path having a second major profile, a second minor profile, a second pitch, and a second thread cross-sectional profile, and an internal cavity comprising an internal surface having the first and second start thread paths, a closed end, and an open end opposite the closed end and comprising an opening, the first thread cross-sectional profile is different from the second thread cross-sectional profile, the method comprises: meshing the complementary male thread of the second medical device connector by contacting at least the first start thread path with the third major profile, thereby forming a first helical void by means of a space encircled by the first start thread path of the first medical device connector and the complementary male thread of the second medical device connector. A medical device connector includes a complementary male thread having a third major profile and a third pitch substantially equal to the first or second pitch, and the first and second initial thread paths are configured to engage the complementary male thread, the method includes: engaging the complementary male thread of the medical device connector by at least contacting the first initial thread path with the third major profile, forming a first gas flow path from a proximal end of the cap to the internal cavity by means of a first helical void formed by space surrounded by the first initial thread path of the cap and the complementary male thread of the medical device connector.

8. The method of claim 7, further comprising: forming a second gas flow path from a proximal end of the cap to the internal cavity by means of a second helical void formed by space surrounded by the second initial thread path of the cap and the complementary male thread of the medical device connector, the second helical void being larger than the first helical void.

9. The method of claim 7, further comprising retaining a disinfectant retaining sponge in the internal cavity substantially at a distal end of the cap.

10. The method of claim 7, wherein the internal surface forms a substantially frustoconical internal cavity having a larger cross section at a proximal end of the cap relative to a distal end of the cap.

11. The method of claim 7, wherein the internal surface forms a substantially cylindrical internal cavity having a cross section larger than the third major profile of the complementary male thread of the medical device connector.

12. The method of claim 7, wherein the first pitch is substantially equal to the second pitch.

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