How to disinfect needleless connectors and store their caps

Abstract

To provide a method of disinfecting a needleless connector, and a method of storing caps.SOLUTION: A method of disinfecting a needleless connector includes the steps of: removing a cover for sealing an opening to an inner cavity of a disinfection cap; interlocking a cap thread of the cap with a mating feature of the needleless connector; and forming at least one venting path between a surface of the cap thread and a surface of the mating feature of the needleless connector, from the inner cavity to outside the housing when the cap thread interlocks with the mating feature of the needleless connector.SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority under 35 USC § 119(e) from U.S. Provisional Application No. 62 / 279,986, filed January 18, 2016, and U.S. Provisional Application No. 62 / 300,247, filed February 26, 2016, the contents of which (including all attachments filed therewith) are hereby incorporated by reference in their entireties.

[0002] SUMMARY OF THE INVENTION In general, exemplary embodiments of the present invention relate to the field of medical antiseptic caps, and in particular to antiseptic caps for use with IV needleless connectors. [Background technology]

[0003] The needleless connector antiseptic cap space has continued to expand rapidly since antiseptic caps were first disclosed in U.S. Patent No. 6,299,499, issued as U.S. Patent No. 6,299,499 (the entire disclosures of both of which are incorporated herein by reference) and introduced to the marketplace to reduce the number of catheter-related bloodstream infections (CRBSIs), a high-impact event with high costs and associated mortality rates. An antiseptic cap such as that disclosed in U.S. Patent No. 6,299,499 is illustrated in FIGS. 1A and 1B, where cap 1 includes an antiseptic pad 2 and a lid 3, and cap 4 also includes an antiseptic pad 5 and a lid 7 as well as threads 6 on its inner periphery 8 for mating with a needleless connector hub. As illustrated in FIG. 2, multiple antiseptic caps 23, such as caps 1 and / or 4 of FIGS. 1A and 1B, can be arranged on a strip 22 that includes an opening 24 for hanging the strip 22 on an IV pole. In the IV pole hanging device 21, the strip 22 can serve as a common lid for the cap 23 placed thereon, e.g., having the same function as lids 3 and / or 7, so that the removed cap 25 can be immediately placed on the needleless connector.

[0004] Antiseptic caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines, and early indications are that the caps will also be incorporated into the 2016 Infusion Nurse Standards (INS) guidelines.

[0005] In developed markets, when utilizing IV catheters, needleless connectors are typically used to shut off the system and then subsequently access it to administer medications or other necessary fluids to the patient via the catheter. The INS Standards of Practice recommend the use of needleless connectors and state that they should be "consistently and thoroughly disinfected using alcohol, tincture of iodine, or a chlorhexidine gluconate / alcohol combination before each access." Disinfection of needleless connectors is ultimately intended to help reduce bacteria that may survive on surfaces and lead to various catheter-related complications, including the previously described CRBSI events. Nurses typically complete this disinfection task by utilizing a 70% IPA alcohol pad, known as "scrubbing the hub." However, compliance with this practice is typically very low. In addition to a lack of compliance with "scrubbing the hub," it is also known through clinician interviews that there is frequent variability in scrubbing time, drying time, and the number of times needleless connectors are scrubbed.

[0006] Cap technology presents significant challenges associated with needleless connectors. All currently available disinfection caps contain 70% isopropyl alcohol as the active disinfectant. However, many needleless connector designs use acrylic or similar materials for the main housing. Acrylic has mild to poor chemical stability in isopropyl alcohol over long exposure times. Therefore, isopropyl alcohol can cause chemical breakdown damage to the acrylic in the form of discoloration and / or cracking of the needleless connector material. In addition, almost all commercially available needleless connectors use silicone materials for their fluid path valve designs. Silicone materials have mild to poor chemical stability in isopropyl alcohol over long exposure times. This can lead to expansion of the silicone components, which can then cause the needleless connector valve to stick and / or fail to close (leading to blood leakage). Furthermore, increased silicone expansion can increase stress on the connector housing, which can exacerbate cracking issues in the outer acrylic needleless connector housing.

[0007] Previously, disinfection caps with alcohol vents (such as those described in U.S. Patent Nos. 5,623,149; 5,623,169; and 5,623,169) have been developed to address the issue of chemical incompatibility of isopropyl alcohol with needleless connector materials. Such vents allow the caps to vent disinfecting alcohol away from the needleless connector more quickly than currently available caps that do not have such vents. Thus, alcohol venting can reduce chemical damage to the needleless connector materials.

[0008] However, such conventional vent mechanisms have several significant drawbacks. One drawback is that the vent mechanism may require forming a dedicated vent hole in the cap, as described, for example, in U.S. Patent No. 6,270,999, or may rely on significant undercut areas and / or the assembly of two molded parts, a main cap housing and a thread ring. Such conventional vent mechanisms relegate the cap design to requiring separate molding of components. These separate parts must be mated, then assembled, and then welded or adhesively bonded. Thus, such designs inherently have higher tooling costs, manufacturing complexity, and production costs than, for example, a single-shot molded cap housing design.

[0009] Therefore, if an antiseptic cap were developed that included a venting mechanism that avoided undercuts, it could eliminate costly assembly and welding processes. Additionally, if an antiseptic cap with increased venting capabilities were developed, it could further reduce malfunctions of needleless connectors. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] U.S. Patent Publication No. 2007 / 011233 [Patent Document 2] U.S. Patent No. 8,740,864 [Patent Document 3] U.S. Patent No. 8,206,514 [Patent Document 4] U.S. Patent No. 7,985,302 [Patent Document 5] U.S. Patent No. 7,780,794 [Patent Document 6] U.S. Patent No. 8,206,514 Summary of the Invention

[0011] According to an embodiment of the present invention, an antiseptic cap includes a housing including a closed top, an essentially cylindrical sidewall, and an open bottom formed by the sidewall with an opening to an interior space within the housing for receiving a tip including a mating feature of the needleless connector. An antiseptic sponge may be configured within the interior cavity with a removable cover sealing the opening to the interior cavity for sealing the sponge within the interior cavity prior to use of the cap. The interior cavity includes at least one thread on an inner sidewall surface of the sidewall. The cap thread is sufficient to mate with a mating feature of the needleless connector, and the cap thread does not correspond to the mating feature of the needleless connector.

[0012] In accordance with another aspect of the invention, at least one of the major diameter, minor diameter, pitch, thread section profile, and number of threads of the cap threads does not correspond to a mating feature of the needleless connector.

[0013] In accordance with another aspect of the present invention, the portion of the sidewall that forms the open bottom includes an inner sidewall surface that forms an opening to the internal 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.

[0014] In accordance with another aspect of the present invention, the open bottom formed by the side walls of the housing is not flat so that there is an outlet space between the flat surface and the bottom of the housing, whereby ventilation of the disinfecting sponge occurs through the opening to the internal cavity, essentially around the exterior of the mating mechanism of the needleless connector and through the outlet space towards the exterior of the cap housing.

[0015] 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 having one or more divots such that the opening to the internal cavity does not form an airtight seal with the outer surface of the needleless connector, whereby ventilation of the disinfecting sponge occurs through the opening to the internal cavity, essentially around the exterior of the mating feature of the needleless connector and through at least one of the divots, toward the exterior of the cap housing.

[0016] In accordance with another aspect of the invention, the housing includes a flared lower portion formed with an open bottom that includes one or more divots regularly or randomly spaced along the bottom inner sidewall surface that define an opening to the interior cavity.

[0017] In accordance with another aspect of the present invention, the cap threads include an extended portion that extends below the open bottom formed by the side wall such that when the cap threads engage with the needleless connector such that the extended portion contacts the top portion of the needleless connector, an escape space exists between the surface of the top portion of the needleless connector and the open bottom, whereby ventilation of the disinfecting sponge occurs through the opening to the internal cavity, essentially around the exterior of the mating feature of the needleless connector and through the escape space toward the exterior of the cap housing.

[0018] In accordance with another aspect of the present invention, the portion of the sidewall forming the open bottom includes a flared bottom portion having an inner sidewall surface forming an opening to the internal cavity such that when the needleless connector is securely engaged with the housing, the open bottom does not form an airtight seal with the outer surface of the needleless connector, thereby allowing ventilation of the disinfecting sponge through the opening to the internal cavity, essentially around the exterior 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, toward the exterior of the cap housing.

[0019] In accordance with another aspect of the invention, the open bottom formed by the sidewalls of the housing is essentially flat.

[0020] In accordance with another aspect of the invention, the open bottom formed by the side walls of the housing is non-flat such that an outlet space exists between a flat surface and the bottom of the housing.

[0021] In accordance with another aspect of the present invention, the internal cavity includes an upper region terminating in a closed top and a lower region terminating in an opening to the internal cavity, the lower region including cap threads, and the upper region including a protrusion into the internal cavity configured to contact and / or engage with a sponge.

[0022] In accordance with another aspect of the present invention, the sidewall includes an inner sidewall surface including a plurality of segments between the cap threads, each of the segments having a slope relative to a longitudinal axis of the cap housing, and at least one of the segments forming the open bottom flares away from the longitudinal axis to form a flared bottom portion.

[0023] In accordance with another aspect of the invention, the interior cavity includes an upper region terminating in a closed top and a lower region terminating in an opening to the interior cavity, and the interior sidewall surface includes a transition section having a straight or curved surface where the interior sidewall surface transitions from the lower region to the upper region such that the area at the bottom of the transition section in the lower region is greater than the area at the top of the transition section in the upper region.

[0024] In accordance with another aspect of the present invention, the sponge ensures that the cap threads do not move into the upper region when mating with a mating feature of the needleless connector so that the sponge maintains contact with the needleless connector and remains away from the inner surface of the closure top.

[0025] According to another aspect of the present invention, the opening to the internal cavity formed by the inner sidewall surface of the bottom portion is essentially circular and includes an opening diameter, and the opening diameter is larger than the flange diameter of the needleless connector such that said opening diameter provides an air gap between the inner sidewall surface of the housing and the needleless connector, whereby the opening to the internal cavity includes an air gap, and ventilation of the disinfecting sponge occurs through the opening to the internal cavity, essentially around the outside of the mating mechanism of the needleless connector and through the air gap toward the outside of the cap housing.

[0026] In accordance with another aspect of the invention, the sidewall includes an inner sidewall surface in a lower region that includes multiple segments between the cap threads, each of the segments having essentially the same slope with respect to a longitudinal axis of the cap housing, and at least one of the segments forming an open bottom and at least one of the segments flaring away from the longitudinal axis to form a flared bottom portion.

[0027] In accordance with another aspect of the present invention, 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 to facilitate engagement with a mating feature of the needleless connector.

[0028] In accordance with another aspect of the present invention, at least a portion of the at least one cap thread includes a non-engaging portion that does not engage with a mating feature of the needleless connector.

[0029] In accordance with another aspect of the present invention, the cap thread includes at least one mating portion formed on at least a portion of the cap thread to facilitate mating with a mating feature of the needleless connector, and at least one non-mating portion that does not engage with a mating feature of the needleless connector.

[0030] In accordance with another aspect of the present invention, a device includes a strip and a plurality of antiseptic caps according to an exemplary embodiment of the present invention disposed on the strip.

[0031] In accordance with an exemplary implementation of the present invention, the strip of the device is essentially flat and includes multiple compartments separated by perforations in the strip, each of the compartments including at least one of multiple antiseptic caps disposed thereon, whereby the perforations facilitate separation at the perforation of at least one of the compartments including at least one antiseptic cap disposed thereon.

[0032] According to another exemplary implementation of the present invention, a strip includes removable covers for a plurality of antiseptic caps disposed thereon, whereby each cap of the plurality of caps is attached to the strip at a bottom of the cap and is releasable from the strip, which uncovers an opening to an internal cavity of the cap when the strip is peeled away.

[0033] According to yet another exemplary implementation of the present invention, the strip is double-sided, including opposing sides each having a plurality of antiseptic caps disposed thereon.

[0034] In accordance with an alternative exemplary implementation of the present invention, the strip includes 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 the closed top of the cap.

[0035] In accordance with yet another exemplary implementation of the present invention, a device includes a mounting portion for selectively positioning a strip having a cap attached thereto onto an IV pole.

[0036] In accordance with an exemplary embodiment of the present invention, a multiple starting thread pattern for use in a medical device connector includes a first starting thread path having a major profile, a minor profile, a pitch, and a first thread segment profile, and at least a second starting thread path having a major profile, a minor profile, a pitch, and a second thread segment profile, wherein the first thread segment profile and the second thread segment profile are different.

[0037] In accordance with an exemplary implementation of the present invention, the first and second starting thread paths have equivalent pitches and are configured to interact with complementary threads of a secondary medical device connector having a high profile and a pitch substantially equivalent to the pitch of the first and second starting thread paths.

[0038] According to another exemplary implementation of the present invention, when the complementary threads engage the first and second starting thread paths, a first helical void is formed by the space enclosed by the complementary threads and the first starting thread path, and a second helical void is formed by the space enclosed by the complementary threads and the second starting thread path, the second helical void being wider than the first helical void.

[0039] According to yet another exemplary implementation of the present invention, the first starting thread path and the second starting thread path further include respective root segment profiles and respective crest segment profiles, wherein the respective root segment profiles are substantially similar and the respective crest segment profiles are substantially different.

[0040] According to yet another exemplary implementation of the present invention, the first starting thread path and the second starting thread path form a female thread pattern, and the complementary threads of the secondary medical device connector have a male thread pattern.

[0041] According to yet another exemplary implementation of the present invention, the first starting thread path and the second starting thread path form a male thread pattern, and the complementary threads of the secondary medical device connector have a female thread pattern.

[0042] According to yet another exemplary implementation of the present invention, the second starting thread path interacts with the complementary thread in a substantially tangential direction.

[0043] According to yet another exemplary implementation of the present invention, the first starting thread path interacts with the complementary threads to substantially engage the complementary threads.

[0044] According to yet another exemplary implementation of the present invention, the first and second starting thread paths have substantially equal pitches.

[0045] In accordance with an exemplary embodiment of the present invention, a cap incorporating multiple starting thread patterns includes an internal cavity, and when complementary threads engage the multiple starting thread patterns, first and second helical cavities form an airflow path from the proximal end of the cap toward the internal cavity.

[0046] In accordance with an exemplary implementation of the present invention, the cap further includes an antiseptic retaining member retained within the interior cavity essentially at the distal end of the cap.

[0047] According to another exemplary implementation of the present invention, the cap further includes an inner surface having first and second starting thread paths and adapted to receive a secondary medical device connector.

[0048] According to yet another exemplary implementation of the present invention, the inner surface of the cap defines an essentially frustoconical interior cavity having a larger cross section at the proximal end of the cap.

[0049] In accordance with yet another exemplary implementation of the present invention, the inner surface of the cap defines an essentially cylindrical interior space having a cross section greater than the major profile of the complementary threads of the secondary medical device connector.

[0050] The objects, advantages and salient features of the present invention will become apparent from the following detailed description, which, taken in conjunction with the accompany drawings, discloses illustrative embodiments of the invention.

[0051] These and other benefits of various embodiments of the present invention will become more apparent from the following detailed description of illustrative embodiments of the invention and from the accompanying illustrative drawings. [Brief explanation of the drawings]

[0052] [Figure 1A] 1 is a cross-sectional view of a conventional cap for a needleless connector. [Figure 1B] 1 is a cross-sectional view of a conventional cap for a needleless connector. [Figure 2] FIG. 1 is a diagram of a conventional device for hanging a cap on an IV pole. [Figure 3A] FIG. 2 is a three-dimensional view of a cap according to an exemplary embodiment of the present invention. [Figure 3B] FIG. 2 is a three-dimensional view of a cap according to an exemplary embodiment of the present invention. [Figure 4A] 1 is a cross-sectional view of a cap according to an exemplary embodiment of the present invention. [Figure 4B] FIG. 10 is another view of a cap according to an exemplary embodiment of the present invention. [Figure 5] 1A and 1B are diagrams of a cap according to an exemplary embodiment of the present invention placed on a medical device such as a needleless connector. [Figure 6] 1 is a cross-sectional view of a cap according to an exemplary embodiment of the present invention placed on a medical device such as a needleless connector. [Figure 7]10A-10C are diagrams of venting within a cap according to an exemplary embodiment of the present invention when placed on a medical device such as a needleless connector. [Figure 8A] 10 is a cross-sectional view of a cap according to another exemplary embodiment of the present invention. [Figure 8B] FIG. 10 is another view of a cap according to another exemplary embodiment of the present invention. [Figure 9] 10 is a diagram of a vent in a cap according to another exemplary embodiment of the present invention disposed on a medical device such as a needleless connector. [Figure 10] 10 is a cross-sectional view of a cap according to another exemplary embodiment of the present invention disposed on a medical device such as a needleless connector. [Figure 11A] FIG. 10 is a cross-sectional view of a cap according to yet another exemplary embodiment of the present invention. [Figure 11B] FIG. 10 is another view of a cap according to yet another exemplary embodiment of the present invention. [Figure 12] 10 is a cross-sectional view of a cap according to yet another exemplary embodiment of the present invention disposed on a medical device such as a needleless connector. [Figure 13] 10 is a cross-sectional view of a cap according to a further exemplary embodiment of the present invention disposed on a medical device such as a needleless connector. [Figure 14A] 10A-10C are diagrams of venting in a cap according to a further exemplary embodiment of the present invention disposed on a medical device such as a needleless connector. [Figure 14B] 10 is another view of a cap according to a further exemplary embodiment of the present invention. [Figure 15] 10 is a three-dimensional view of a cap according to a still further exemplary embodiment of the present invention. [Figure 16] 10 is a cross-sectional view of a cap according to a still further exemplary embodiment of the present invention disposed on a medical device such as a needleless connector. [Figure 17A] 10 is a cross-sectional view of a cap according to a still further exemplary embodiment of the present invention. [Figure 17B]10 is a cross-sectional view of a cap according to a still further exemplary embodiment of the present invention disposed on a medical device such as a needleless connector. [Figure 17C] 10 is a diagram of a vent in a cap according to a still further exemplary embodiment of the present invention disposed on a medical device such as a needleless connector. [Figure 18] 10 is a cross-sectional view of a cap according to yet another further exemplary embodiment of the present invention. [Figure 19] 10 is a cross-sectional view of a cap according to an exemplary implementation of a still further exemplary embodiment of the present invention. [Figure 20A] 10 is a cross-sectional view of a cap according to yet another exemplary embodiment of the present invention disposed on a medical device such as a needleless connector. [Figure 20B] FIG. 10 is another view of a cap according to yet another exemplary embodiment of the present invention. [Figure 20C] 10 is a diagram of a vent in a cap according to yet another exemplary embodiment of the present invention disposed on a medical device such as a needleless connector. [Figure 21A] 10 is a cross-sectional view of a cap according to yet another exemplary embodiment of the present invention disposed on a medical instrument such as a needleless connector. [Figure 21B] FIG. 10 is another view of a cap according to yet another exemplary embodiment of the present invention. [Figure 21C] 10 is a diagram of a vent in a cap according to yet another exemplary embodiment of the present invention disposed on a medical device such as a needleless connector. [Figure 22] FIG. 1 is a cross-sectional view of a conventional female (Luer) lock conical fitting. [Figure 23A] 10 is a cross-sectional view of a cap according to another exemplary embodiment of the present invention. [Figure 23B] FIG. 10 is a three-dimensional view of a cap according to another exemplary embodiment of the present invention. [Figure 24A] 1A-1C are technical drawings of various perspective views illustrating a cap according to an exemplary implementation of an exemplary embodiment of the present invention; [Figure 24B]1 is a technical drawing illustrating a cap according to an exemplary implementation of an exemplary embodiment of the present invention; [Figure 24C] 1 is a technical drawing illustrating a cap according to an exemplary implementation of an exemplary embodiment of the present invention; [Figure 24D] 1 is a technical drawing illustrating a cap according to an exemplary implementation of an exemplary embodiment of the present invention; [Figure 24E] 1 is a technical drawing of a cross-sectional view illustrating a cap according to an exemplary implementation of an exemplary embodiment of the present invention; [Figure 24F] 1 is a technical drawing of a cross-sectional view illustrating a cap according to an exemplary implementation of an exemplary embodiment of the present invention; [Figure 24G] 1 is a technical drawing illustrating an enlarged view of a cap according to an exemplary implementation of an exemplary embodiment of the present invention; [Figure 24H] 1 is a technical drawing of a cross-sectional view illustrating a cap according to an exemplary implementation of an exemplary embodiment of the present invention; [Figure 24I] 1 is a technical drawing illustrating an enlarged view of a cap according to an exemplary implementation of an exemplary embodiment of the present invention; [Figure 25A] 1A-1C illustrate a device according to an exemplary embodiment of the present invention for hanging multiple caps on an IV pole. [Figure 25B] 1A-1C illustrate a device according to an exemplary embodiment of the present invention for hanging multiple caps on an IV pole. [Figure 25C] 10A-10C show a device according to another exemplary embodiment of the present invention for hanging multiple caps on an IV pole. [Figure 25D] 10A-10C illustrate a device according to yet another exemplary embodiment of the present invention for hanging multiple caps on an IV pole. [Figure 26A] 10A-10C show a device according to a further exemplary embodiment of the present invention for hanging multiple caps on an IV pole. [Figure 26B] 10A-10C show a device according to yet a further exemplary embodiment of the present invention for hanging multiple caps on an IV pole. DETAILED DESCRIPTION OF THE INVENTION

[0053] Throughout the drawings, like reference numerals will be understood to refer to like parts, components and structures.

[0054] The matters exemplified in this description are provided to aid in a comprehensive understanding of the exemplary embodiments of the present invention. Therefore, those skilled in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the invention. Also, descriptions of well-known functions and structures are omitted for clarity and conciseness.

[0055] An exemplary embodiment of the present invention provides an antiseptic cap that utilizes a novel, single-shot moldable cap design that has increased venting capabilities while simultaneously achieving antiseptic fluid venting by incorporating cap features (major thread diameter, minor thread diameter, thread pitch, thread segment profile, and number of thread features) that do not correspond to mating features on the IV catheter needleless connector hub. The cap's minor thread features grip the needleless connector's major thread features, creating an interference friction fit between the two parts. These non-matching thread features result in significant spiral venting paths around the exterior of the needleless connector's major thread segments between the cap and the IV hub. These paths lead from an alcohol-soaked antiseptic sponge in the top section of the cap, spiral down the inner diameter of the cap, and vent out the bottom of the cap to the atmosphere.

[0056] As will be readily recognized by those skilled in the relevant art, in the following description, a "feature that does not correspond to a mating feature" is defined as a feature that is not identical to the mating feature in all essential elements or respects. The definition of "identical" is outside the industry average tolerances for injection-moldable plastic parts and injection-moldable plastic part assemblies. Also, it should be noted that descriptive terms such as "tip," "hub," "thread," "sponge," "projection," "ramp," etc. are used throughout this specification for ease of understanding, but are not intended to limit any components that may be used in combination or individually to implement various aspects of embodiments of the present invention.

[0057] Additionally, cap thread feature sizing can be optimized in conjunction with the needleless connector thread or mating feature to maximize the cap's vent rate performance while still meeting other product requirements. Manufacturing injection demolding can be achieved by spiral ejection of the part or rotating the mold core. Therefore, two-shot injection and / or plastic part assembly is not required with the design concept according to exemplary embodiments of the present invention.

[0058] Referring now to the drawings, in which like reference numerals designate identical or corresponding parts throughout the several views, embodiments of the present invention are described as follows.

[0059] According to an exemplary implementation of an embodiment of the present invention as illustrated in Figures 3A, 3B, and 4-7, a cross-threaded antiseptic cap 300 can fit over the tip or hub 12 of a needleless connector 9 and includes a housing 302 including a closed top 322, an essentially cylindrical sidewall 304 having an outer sidewall surface 320, and an open bottom 324 having an opening 326 to an internal cavity 328 within the housing 302 for receiving the tip of the needleless connector 9. The bottom 324 formed by the sidewall 304 of the housing 302 is uneven such that a space 370 exists between the flat surface 310 and the bottom 324 of the cap 300. The internal cavity 328 accommodates an antiseptic sponge 380 soaked in alcohol and has threads (or mating features) 340 on an 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 feature) 13 of the needleless connector 9. A disinfecting sponge 380 is included. A removable cover 399 can be attached to the bottom 324 of the cap 300 to seal the internal cavity 328.

[0060] 6 and 7 , according to an exemplary implementation, the thread pitch, thread segment profile, and / or number of threads of the cap 300 do not correspond to the threads 13 of the needleless connector 9. Because the threads 340 of the cap 300 do not correspond to the threads 13 of the needleless connector 9, ventilation 311 of the alcohol-soaked disinfecting sponge 380 occurs through one opening 326 into the interior cavity 328, essentially around the exterior of the threads 13 of the needleless connector 9 and through space 370 toward the atmosphere of the cap housing 302.

[0061] 8A-10 , a threaded major gap antiseptic cap 800 can fit over the tip 12 of a needleless connector 9 and includes a housing 802 including a closed top 822, an essentially cylindrical sidewall 804 having an outer sidewall surface 820, and an open bottom 824 having an opening 826 to an internal cavity 828 within the housing 802 for receiving the tip of the needleless connector 9. The bottom 824 formed by the sidewall 804 of the housing 802 is uneven such that a space 870 exists between the flat surface 810 and the bottom 824 of the cap 800. The internal cavity 828 accommodates an antiseptic sponge 880 soaked in alcohol and has threads 840 on an 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 interior cavity 828 containing the disinfecting sponge 880 .

[0062] The pitch of the threads 840 corresponds to the pitch of the threads 13 of the needleless connector 9. However, the contours (large contour 841 and / or small contour 842) of the threads 840 of the cap 800 do not correspond to the threads 13 of the needleless connector 9. Because the threads 840 of the cap 800 do not correspond to the threads 13 of the needleless connector 9, ventilation 811 of the alcohol-soaked disinfecting sponge 880 occurs through one opening 826 to the internal cavity 828, essentially around the exterior of the threads 13 of the needleless connector 9 and through space 870 toward the atmosphere of the cap housing 802.

[0063] 11A, 11B, and 12, an antiseptic cap 1100 with a thread castellation design can fit over the tip 12 of a needleless connector 9 and includes a housing 1102 including a closed top 1122, an essentially cylindrical sidewall 1104 having an outer sidewall surface 1120, and an open bottom 1124 having an opening 1126 to an internal cavity 1128 inside the housing 1102 for receiving the tip 12 of the needleless connector 9. The bottom 1124 formed by the sidewall 1104 of the housing 1102 includes an irregular bottom inner sidewall surface 1132 with a divot 1136 such that the opening 1126 does not form an airtight seal with the outer surface 25 of the needleless connector 9.

[0064] In the exemplary implementation, the housing 1102 includes a flared lower portion 1190 formed in the bottom 1124, which includes a divot 1136. Any number of one or more divots 1136 may be present, regularly or randomly spaced along the bottom inner sidewall surface 1132. The internal cavity 1128 contains a disinfecting sponge 1180 soaked in alcohol, such that the sponge 1180 contacts and disinfects at least the tip 12 of the needleless connector 9, similar to the embodiment of FIG. 10 . The internal cavity 1128 includes threads 1140 on the inner sidewall surface 1130 of the sidewall 1104.

[0065] The pitch of the threads 1140 corresponds to the pitch of the threads 13 of the needleless connector 9. However, the contours (large contour 1141 and / or small contour 1142) of the threads 1140 of the cap 1100 do not correspond to the threads 13 of the needleless connector 9. Because the threads 1140 of the cap 1100 do not correspond to the threads 13 of the needleless connector 9, ventilation 1111 of the alcohol-soaked disinfecting sponge 1180 essentially occurs around the exterior of the threads 13 of the needleless connector 9 and through one or more divots 1136 in the opening 1126 to the internal cavity 1128 toward the atmosphere of the cap housing 1102. The bottom 1124 formed by the sidewall 1104 of the housing 1102 can be, but need not be, essentially flat (in contrast to the exemplary embodiment of FIG. 10 , in which a space 870 exists between the flat surface 810 and the bottom 824 of the cap 800). A removable cover 1199 can be attached to the bottom 1124 of the cap 1100 to seal the interior cavity 1128 containing the disinfecting sponge 1180 .

[0066] 13, 14A, and 14B, an extended thread design clearance antiseptic cap 1300 can fit over the tip 12 of a needleless connector 9 and includes a housing 1302 including a closed top 1322, an essentially cylindrical sidewall 1304 having an outer sidewall surface 1320, and an open bottom 1324 having an opening 1326 to an internal cavity 1328 within the housing 1302 for receiving the tip of the needleless connector 9. The internal cavity 1328 includes an upper region 1312 and a lower region 1314 and houses an alcohol-soaked antiseptic sponge 1380. The lower region 1314 includes engaging threads 1340 on an inner sidewall surface 1330 of the sidewall 1304 for engaging the threads 1330 of the needleless connector 9. The thread 1340 includes an extended portion 1348 that extends below the bottom 1324 formed by the side wall 1304 of the housing 1302 so that when the cap 1300 is mounted on the connector 9 so that the extended portion 1348 contacts the top portion 25 of the needleless connector 9, a space 1370 exists between the surface 1310 of the top portion 25 of the needleless connector 9 and the bottom 1324 of the cap 1300.

[0067] In an exemplary implementation, the upper region 1312 may include a protrusion 1355 from the lateral sidewall surface 1330 and / or a protrusion 1357 from the inner surface of the top 1322 that engages or contacts the antiseptic sponge 1380. The pitch of the mating threads 1340 corresponds to the pitch of the threads 13 of the needleless connector 9. However, the contours (major contour 1341 and / or minor contour 1342) of the mating threads 1340 of the cap 1300 do not correspond to the threads 13 of the needleless connector 9. Because the mating threads 1340 of the cap 1300 do not correspond to the threads 13 of the needleless connector 9, ventilation 1311 of the alcohol-soaked antiseptic sponge 1380 occurs through one opening 1326 to the internal cavity 1328, essentially around the exterior of the threads 13 of the needleless connector 9 and through a space 1370 toward the atmosphere of the cap housing 1302. In an exemplary implementation, the bottom 1324 formed by the sidewalls 1304 of the housing 1302 may, but need not be, essentially flat (in contrast to the exemplary embodiment of FIG. 10 , in which a space 870 exists between the flat surface 810 and the bottom 824 of the cap 800). A removable cover 1399 may be attached to the bottom 1324 of the cap 1300 to seal an internal cavity 1328 that contains the disinfecting sponge 1380.

[0068] 15-19, an antiseptic cap 1500 can fit over the tip 12 of a needleless connector 9 and includes a housing 1502 including a closed top 1522, a sidewall 1504 having an outer sidewall surface 1520, and an open bottom 1524 having an opening 1526 to an internal cavity 1528 within the housing 1502 for receiving the tip of the needleless connector 9. The internal cavity 1528 includes an upper region 1512 and a lower region 1514 and houses an antiseptic sponge 1580 soaked in alcohol. The bottom 1524 formed by the sidewalls 1504 of the housing 1502 includes a flared bottom portion 1590 having an inner sidewall surface 1532 such that the opening 1526 does not form an airtight seal with the outer surface 25 of the needleless connector 9 when the tip of the connector 9 is securely engaged at least within the lower region 1514 of the cavity 1528. A disinfecting sponge 1580 is included. A removable cover 1599 can be attached to the bottom 1524 of the cap 1500 to seal the internal cavity 1528.

[0069] In an exemplary implementation, the opening 1526 to the internal cavity 1528 formed by the inner sidewall surface 1532 is essentially circular and has an opening diameter 26 that is larger than the flange diameter 1533 of the outer surface 25 of the needleless connector 9 such that the opening diameter 26 provides an air gap 1527 between the inner sidewall surface 1532 and the outer surface 25 of the needleless connector 9.

[0070] The lower region 1514 includes threads 1540 on the inner sidewall surface 1530 of the sidewall 1504 for engaging with the threads 13 of the needleless connector 9. In an exemplary implementation, the upper region 1512 may include a protrusion 1555 on the inner sidewall surface 1530 and / or a protrusion (not shown) on the inner surface of the top 1522 (such as protrusion 1357 illustrated in the example of FIG. 13) that engages or contacts the antiseptic sponge 1580.

[0071] The pitch of the threads 1540 corresponds to the pitch of the threads 13 of the needleless connector 9. However, the contours (major contour 1541 and / or minor contour 1542) of the threads 1540 of the cap 1500 do not correspond to the threads 13 of the needleless connector 9. Because the mating threads 1540 of the cap 1500 do not correspond to the threads 13 of the needleless connector 9, ventilation 1511 of the alcohol-soaked disinfecting sponge 1580 essentially occurs around the exterior of the threads 13 of the needleless connector 9 and through the openings 1526 to the internal cavity 1528 toward the atmosphere of the cap housing 1502. In an exemplary implementation, ventilation 1511 occurs through the openings 1526 and via the ventilation gap 1527.

[0072] The bottom 1524 formed by the sidewalls 1504 of the housing 1502 may be, but need not be, essentially flat (in contrast to the exemplary embodiment of FIG. 10 in which a space 870 exists between the flat surface 810 and the bottom 824 of the cap 800).

[0073] 17A, 17B, and 17C, the inner sidewall surface 1530 in the lower region 1514 of the cap 1500 can essentially include segments 1530C, 1530D, 1530E, and 1530F between the threads 1540, each segment having a slope with respect to the longitudinal axis A. In a further example implementation, the inner sidewall surface 1530 in segments 1530E and 1530F forms an opening 1526 that flares away from the longitudinal axis A. In yet a further example implementation, the inner area at the top of segment 1530C can be smaller than the area at the bottom of segment 1530F that forms opening 1526. In yet a further exemplary implementation, the area at the top of the section 1530D can be configured to prevent further insertion of the needleless connector 9 into the cavity 1528, such that the tip 12 of the needleless connector 9 essentially stops at the top of the section 1530D, as shown in the example of FIG. 16.

[0074] In yet a further exemplary implementation, the inner sidewall surface 1530 in the upper region 1512 of the cap 1500 can include segments 1530AA and 1530A essentially between the protrusions 1555, each segment having a slope with respect to the longitudinal axis A. In still a further exemplary implementation, the inner sidewall surface 1530 can include a transition segment 1530B having a straight (see example in FIG. 19 ) or curved (see examples in FIGS. 17A , 17B, 17C, and 18 ) surface where the inner sidewall surface 1530 transitions from the lower region 1514 to the upper region 1512 such that the area at the bottom of the segment 1530B in region 1514 is greater than the area at the top of the segment 1530B in region 1512. The protrusion 1555 and / or the smaller area at the top of compartment 1530B can prevent the sponge 1580 from being moved into the upper region 1512 when the cap 1500 engages with the needleless connector 9, so that when the tip 12 of the connector 9 is secured within the cavity 1528 of the cap 1500, the sponge 1580 can be compressed and / or retained within a certain region of the cavity 1528, for example essentially within compartments 1530B and 1530C.

[0075] In yet a further exemplary implementation of an embodiment of the present invention as illustrated in FIG. 18, the inner sidewall surface 1530 in the lower region 1514 of the cap 1500 can essentially include segments 1530C, 1530D, and 1530E between the threads 1540, as well as segment 1530F as the bottom-most segment, or an aperture step below segment 1530F. All segments have essentially the same slope or angle with respect to the longitudinal axis A. However, unlike the exemplary implementation illustrated in FIG. 19, segments 1530C, 1530D, 1530E, and / or 1530F are not collinear.

[0076] 19, the inner sidewall surface 1530 in the lower region 1514 of the cap 1500 may include essentially collinear 1531 segments 1530C, 1530D, and 1530E, among which all segments of the thread 1540 have essentially the same inclination or angle with respect to the longitudinal axis A. However, unlike the exemplary implementation illustrated in FIG. 18, segment 1530F may be configured as an integral, bottom-most portion of segment 1530E.

[0077] In yet another exemplary implementation, the cap 1500 includes a ridge 1598 formed on the outer sidewall surface 1520 of the housing 1502 to facilitate a better grip of the cap 1500, for example, when removing the cover 1599 and handling the cap 1500 to engage and / or disengage the needleless connector 9.

[0078] 20A, 20B, and 20C, an antiseptic cap 2000 can fit over the tip 12 of a needleless connector 9 and includes a housing 2002 including a closed top 2022, a sidewall 2004 having an outer sidewall surface 2020, and an open bottom 2024 having an opening 2026 to an internal cavity 2028 within the housing 2002 for receiving the tip of the needleless connector 9. The internal cavity 2028 accommodates an antiseptic sponge 2080 soaked in alcohol. The bottom 2024 formed by the sidewall 2004 of the housing 2002 includes a bottom portion 2090 having an inner sidewall surface 2032 such that the opening 2026 does not form an airtight seal with the outer surface 25 of the needleless connector 9 when the tip of the connector 9 is securely engaged within the cavity 2028. 15, includes a disinfecting sponge 2080. A removable cover such as 1599 can be attached to the bottom 2024 of the cap 2000 to seal the internal cavity 2028.

[0079] In an exemplary implementation, the opening 2026 to the internal cavity 2028 formed by the inner sidewall surface 2032 is essentially circular and has an opening diameter 2026A that is larger than the flange diameter 2033 of the outer surface 25 of the needleless connector 9 such that the opening diameter 2026A provides an air gap 2027 between the inner sidewall surface 2032 and the outer surface 25 of the needleless connector 9.

[0080] The internal cavity 2028 includes threads 2040 on an inner sidewall surface 2030 of the sidewall 2004 for engaging with the threads 13 of the needleless connector 9. In an exemplary implementation, at least a portion of the threads 2040 can include a protrusion 2040A to facilitate more secure engagement with the threads 13 of the needleless connector 9.

[0081] The pitch of the threads 2040 corresponds to the pitch of the threads 13 of the needleless connector 9. However, the contours (major contour 2041 and / or minor contour 2042) of the threads 2040 of the cap 2000 do not correspond to the threads 13 of the needleless connector 9. Because the mating threads 2040 of the cap 2000 do not correspond to the threads 13 of the needleless connector 9, ventilation 2011 of the alcohol-soaked disinfecting sponge 2080 essentially occurs around the exterior of the threads 13 of the needleless connector 9 and through the openings 2026 to the internal cavity 2028 toward the atmosphere of the cap housing 2002. In an exemplary implementation, ventilation 2011 occurs through the openings 2026 and via the ventilation gap 2027. A removable cover 2099 can be attached to the bottom 2024 of the cap 2000 to seal the interior cavity 2028 containing the disinfecting sponge 2080 .

[0082] According to an exemplary implementation of an embodiment of the present invention as illustrated in FIG. 20A, the inner sidewall surface 2030 of the cap 2000 can include segments such as 2030A essentially between the threads 2040, each segment having essentially the same inclination with respect to the longitudinal axis A.

[0083] 21A, 21B, and 21C, an antiseptic cap 2100 can fit over the tip 12 of a needleless connector 9 and includes a housing 2102 including a closed top 2122, a sidewall 2104 having an outer sidewall surface 2120, and an open bottom 2124 having an opening 2126 to an internal cavity 2128 within the housing 2102 for receiving the tip of the needleless connector 9. The internal cavity 2128 accommodates an antiseptic sponge 2180 soaked in alcohol. The bottom 2124 formed by the sidewall 2104 of the housing 2102 includes a bottom portion 2190 having an inner sidewall surface 2132 such that the opening 2126 does not form an airtight seal with the outer surface 25 of the needleless connector 9 when the tip of the connector 9 is securely engaged within the cavity 2128. As in the embodiment of FIG. 15, a removable cover such as 1599 can be attached to the bottom 2124 of the cap 2100 to seal the interior cavity 2128 containing the disinfecting sponge 2180.

[0084] In an exemplary implementation, the opening 2126 to the internal cavity 2128 formed by the inner sidewall surface 2132 is essentially circular and has an opening diameter 2126A that is larger than the flange diameter 2133 of the outer surface 25 of the needleless connector 9 such that the opening diameter 2126A provides an air gap 2127 between the inner sidewall surface 2132 and the outer surface 25 of the needleless connector 9.

[0085] The internal cavity 2128 includes threads 2140 on an inner sidewall surface 2130 of the sidewall 2104 for engaging with the threads 13 of the needleless connector 9. In an exemplary implementation, at least a portion of the threads 2140 can include a protrusion 2140A to facilitate more secure engagement with the threads 13 of the needleless connector 9.

[0086] The pitch of the threads 2140 corresponds to the pitch of the threads 13 of the needleless connector 9. However, the contours (large contour 2141 and / or small contour 2142) of the threads 2140 of the cap 2100 do not correspond to the threads 13 of the needleless connector 9. Because the mating threads 2140 of the cap 2100 do not correspond to the threads 13 of the needleless connector 9, ventilation 2111 of the alcohol-soaked disinfecting sponge 2180 essentially occurs around the exterior of the threads 13 of the needleless connector 9 and through the openings 2126 to the internal cavity 2128 toward the atmosphere of the cap housing 2102. In an exemplary implementation, ventilation 2111 occurs through the openings 2126 and via the ventilation gap 2027.

[0087] In an exemplary implementation, the internal cavity 2128 includes threads 2143 on an inner sidewall surface 2130 of the sidewall 2104 that have a smaller profile than the threads 2140 and do not engage with the threads 13 of the needleless connector 9, for example, in a friction fit manner. A removable cover 2199 can be attached to the bottom 2124 of the cap 2100 to seal the internal cavity 2128 that contains the antiseptic sponge 2180.

[0088] In yet another exemplary implementation as illustrated in FIG. 21C and similar to the exemplary embodiment of FIG. 17C, the cap 2100 includes a ridge 2198 formed on the outer sidewall surface 2120 of the housing 2102 to facilitate a better grip of the cap 2100, for example, when handling the cap 2100 to remove the cover 1599 and engage and / or disengage the needleless connector 9.

[0089] 23A and 23B illustrate an antiseptic cap 3000 according to an exemplary implementation of an embodiment of the present invention that receives the tip of a needleless connector 93, which is a female 6% (Luer) lock conical fitting with external threads 113 configured in accordance with International Standard ISO 594-2:1998(E) as shown in annotated FIG. 22, where α is the thread or lug bearing surface angle relative to the separation between the axis of the lock fitting and a plane perpendicular to the lock fitting, which may be referred to in a non-limiting exemplary manner as a connector thread α feature 133A, and γ is the separation between the axis of the lock fitting and a plane perpendicular to the lock fitting. where Λ is the minimum angle of the external thread or lug non-bearing surface relative to the separation, 2X is the outer diameter across the lug or external thread, which may be referred to in a non-limiting exemplary manner as connector thread feature 133B, E is the minimum length of the male lock fitting, G is the maximum outer diameter or maximum inner diameter of the external thread of the female lock fitting at the base of the lug, S is the lug thread width or thread width of a female lock fitting having a lug or external thread, and Y is the maximum width of the thread at the base or base of the lug (axially) of the female lock fitting to be measured at the point corresponding to the outer diameter equal to G.

[0090] 23A and 23B, the cross-sectional view of the antiseptic cap 3000 includes a housing 3002 including a closed top 3022, a sidewall 3004 having an outer sidewall surface 3020, and an open bottom 3024 having an opening 3026 to an internal cavity 3028 within the housing 3002 for receiving the needleless connector 93. The internal cavity 3028 may, but need not, contain an alcohol-soaked antiseptic sponge 3080. As in the embodiment of FIG. 15, 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 the antiseptic sponge 3080 disposed therein (as shown in FIG. 23B).

[0091] The internal cavity 3028 of the cap 3000 includes one or more threads (bumps, lugs, or ribs) 3040, 3042 on the inner sidewall surface 3030 of its sidewall 3004. In an exemplary implementation, at least a portion or the entire thread of at least one thread, such as thread 3040, may include an additional protrusion (bump, lug, or rib) 3040A extending from the thread 3040 into the cavity 3028. The protrusion 3040A engageably interacts with at least a portion of the threads 133 of the connector 93, e.g., a portion of the connector thread alpha feature 133A and / or a portion of the connector thread major feature 133B, to facilitate engagement of the connector 93 within the cavity 3028 of the cap 3000.

[0092] In an exemplary implementation, threads 3042 on inner sidewall surface 3030 of sidewall 3004 have a smaller profile than threads 3040 and do not engage, e.g., in a friction fit manner, with threads 133 of connector 93. Threads 3040 and 3042 may be formed as a single continuous or partial thread with selectively formed features of threads 3040 and / or 3042 thereon, or as continuous or partial threads alternating, e.g., at 180 degrees or 90 degrees (e.g., as illustrated in FIGS. 24A-24I).

[0093] In another or additional exemplary implementation, thread(s) such as thread 3042 without additional protrusions can facilitate axial alignment of cap 3000 with connector 93 when placing cap 3000 on connector 93 or inserting connector 93 into cavity 3028 of cap 3000, for example, as illustrated in FIGS. 23A and 23B . In an exemplary implementation, the major contour of thread 3040 within cavity 3028 can correspond or match thread major feature 133B of connector 93 essentially exactly or within a given tolerance. In other words, thread 3042 interacts with thread 133 essentially tangentially at their surface contact. For example, in a cylindrical embodiment of cap 3000, thread 3042 can meet thread 133 essentially at a contact diameter.

[0094] In an exemplary implementation in which the cap 3000 and cavity 3028 are essentially frustoconical with a larger cross-section present at the top 3022, as shown in the example of FIG. 23A , the engaging threads 3040 can provide a more secure engagement of the connector 93 as it advances into the cavity 3028. The non-engaging threads 3042 can provide an interference fit to facilitate, for example, further alignment or retention of the connector 93 within the cavity 3028.

[0095] In yet another or additional exemplary implementation, the pitch and / or profile of threads 3040 and / or 3042 of cap 3000 does not correspond to the pitch and / or profile of threads 133 of connector 93. Thus, venting within cavity 3028 of cap 3000 occurs essentially around the exterior of threads 133 when connector 93 is inside cavity 3028.

[0096] In yet another or additional exemplary implementation, the pitch of threads 3040 corresponds to the pitch of threads 133 of connector 93. However, the profile of threads 3040 does not correspond to threads 133. Because mating threads 3040 do not correspond to threads 133, ventilation within internal cavity 3028 essentially occurs around the exterior of threads 133 when connector 93 is inside internal cavity 3028.

[0097] In yet another exemplary implementation as illustrated in FIG. 24A and similar to the exemplary embodiments of FIGS. 17C and 21B, the cap 3000 includes ridges 3098 formed on the outer sidewall surface 3020 of the housing 3002 to facilitate a better grip of the cap 3000, for example, when handling the cap 3000 and engaging and / or disengaging the connector 93 (into the cavity 3028) and / or disengaging the connector 93 (from the cavity 3028).

[0098] 24A-24I, an exemplary implementation of an embodiment of the present invention will be described in terms of certain dimensional characteristics of various components of an antiseptic cap 3000. Both relative and specific numerical characteristics presented in FIG. 24A-24I are intended to facilitate a more complete understanding of an exemplary implementation of an embodiment of the present invention, without limiting the scope of the invention as set forth in the claims. As in the example of FIG. 15, a removable cover such as 1599 can be attached to the bottom 3024 of the cap 3000 to seal the interior cavity 3028, with or without an antiseptic sponge 3080 disposed therein (as shown in FIG. 24A-24I).

[0099] FIG. 24A shows a three-dimensional view of cap 3000 from different perspectives, from an angle showing the top 3022 of cap 3000 (left) and from an angle showing the bottom 3024 of cap 3000 (right). FIG. 24B shows a side view of cap 3000 illustrating the 6-degree frustoconical configuration of body 3002 of cap 3000 in accordance with an exemplary implementation of an embodiment of the present invention. FIG. 24C is a view of cap 3000 from top 3022. FIG. 24D is a view of cap 3000 from bottom 3024, which also shows opening 3026 to interior cavity 3028, threads 3040 / 3042, and includes the designations AC-AC, DD, and EE for the cross-sectional views of cap 3000 illustrated in FIGS. 24E, 24F, and 24H, respectively. In an exemplary implementation, the cap 3000 can include divots 2499 , which are anti-rotation lugs used for injection molding when manufacturing the cap 3000 formed in the bottom 3024 .

[0100] Figure 24E is a cross-sectional view AC-AC (see Figure 24D) of cap 3000 showing the relative dimensional characteristics of cap body 3002, including opening 3026 and thread pitch, and divot 2499 (if formed in bottom 3024 of cap 3000). Figure 24F is a cross-sectional view DD (see Figure 24D) of cap 3000, also showing the relative dimensional characteristics of cap body 3002, including opening 3026 and thread pitch, and detail B of top 3022 features and thread 3040. Figure 24H is a cross-sectional view EE (see Figure 24D) of cap 3000 further showing the relative dimensional characteristics of cap body 3002, including opening 3026 and thread pitch, and detail A of top 3022 features and thread 3040.

[0101] Figure 24G is an enlarged cross-sectional view B (see Figure 24F) of specific relative dimensional characteristics of thread 3040 according to an exemplary implementation of an embodiment of the present invention. Figure 24I is an enlarged cross-sectional view A (see Figure 24H) of specific relative dimensional characteristics of thread 3042 according to an exemplary implementation of an embodiment of the present invention. As shown in the examples of Figures 24G and 24I, thread 3040 and thread 3042 can have substantially similar root segment profiles 3040R and 3042R, respectively, and substantially different crest segment profiles 3040C and 3042C.

[0102] 25A and 25B, a dispensing device 2260 according to an exemplary embodiment of the present invention includes a plurality of caps 2230 disposed on a perforated strip 2220. In an exemplary implementation, perforations 2270 are formed between the caps 2230 disposed on the strip 2220 to define a portion 2272 of the strip 2220 having at least one cap 2230 disposed thereon. The caps 2230 may be structurally and functionally configured like any of the caps illustrated in and described above with reference to the examples of FIGS. 1A, 1B, and 3A-21C. In an exemplary implementation, the strip 2220 may be a peel strip configured as a cap cover attached to the bottom of each cap 2230 to seal the interior cavity of each cap 2230, for example, as described above with reference to FIGS. 1A, 1B, 4B, 8B, 11B, 14B, 15, 20B, 21B, and 25A.

[0103] As shown in the embodiment of Figure 25A, each cap 2230 can be peeled or separated from strip 2220 for immediate use, e.g., to cap a needleless connector. On the other hand, as shown in the embodiment of Figure 25B, portion 2272 including cap 2230 disposed thereon can be selectively separated from strip 2220 such that the interior cavity of cap 2230 remains sealed by portion 2272, similar to the individual caps shown in the embodiments of Figures 1A, 1B, 4B, 8B, 11B, 14B, 15, 20B, and 21B.

[0104] According to exemplary embodiments of the invention, dispensing device 2260 may be configured to have a perforated strip 2220 having a single row of caps 2230 as shown in Figures 25A and 25B, or a perforated strip 2250 having multiple rows of caps 2230 separated by perforations 2273 as illustrated in the example of Figure 25C, which shows a top view of such an implementation. According to yet another exemplary embodiment as illustrated in the side view of Figure 25D, dispensing device 2260 may be configured to have a double-sided perforated peel strip 2255 having two opposing sides 2265 and 2267, and caps 2230 attached on both sides thereof, such that two sealed caps 2230 can be selectively detached from strip 2255 at perforations 2275 for later use (see Figure 25D) and / or individually removed from opposite sides of strip 2255 for immediate use (see Figure 25D).

[0105] As illustrated in Figures 25A, 25B, 25C, and 25D, strips 2220 / 2250 / 2255 are essentially flat and have perforations in the middle of each cap 2230. Thus, each perforated cap strip section can be torn or separated from the main strip (see Figure 25B) to allow caps 2230 to be peeled open for later use. Or, alternatively, each cap can be peeled open from the cap strip (see Figure 25A) for immediate use.

[0106] In an exemplary implementation, strip 2220 / 2250 / 2255 includes an attachment portion, such as opening 2240, at at least one end thereof to accommodate, for example, an IV pole hanger so that device 2260 can be conveniently hung on an IV pole. Other variations of attachment portions, such as hooks or the like, or means for selectively positioning or hanging strip 2220 / 2250 / 2255 on an IV pole, can be integrated into or attached to strip 2220 / 2250 / 2255, as would be readily recognized by one skilled in the art.

[0107] 26A and 26B, a dispensing device 2360 according to an exemplary embodiment of the present invention includes a plurality of caps 2330 disposed on a hanging strip 2320, which may be of any shape, such as, for example, an injection-molded runner bar including an attachment portion, such as a top hook 2340, or other means for selectively positioning or hanging the strip on an IV pole. The caps 2330 may be structurally and functionally configured like any of the caps illustrated in and described above with reference to the examples of FIGS. 1A, 1B, and 3A-21C. According to an exemplary implementation, each cap 2330 is sealed with a peel strip 2372, similar to the individual caps illustrated in the examples of FIGS. 1A, 1B, 4B, 8B, 11B, 14B, 15, 20B, and 21B.

[0108] Further, in an exemplary implementation, each cap 2330 is attached to strip 2372, for example, by prongs 2380 attached to and extending from a surface of strip 2372. In an exemplary implementation, prongs 2380 are configured as runner gate prongs that connect each cap 2330 (e.g., at the exterior surface of the top of the cap) with strip 2372, which is configured as a main injection molded runner bar. As shown in the example of FIG. 26A , a cap 2330 that has been torn or separated from prongs 2380 has peel film 2372 still attached to it so that it can be used at a later time.

[0109] 26B, the dispensing device 2360 may have multiple prongs 2380 attached to the strip 2320 on diametrically opposite sides thereof, such that, for example, two caps 2330 can be attached to the strip 2320 at essentially the same longitudinal location on the strip 2320. Such a configuration may, for example, allow for twice the number of caps to be attached to the same length of strip.

[0110] Although the present invention has been shown and described with reference to specific exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the embodiments of the present invention. For example, the disinfecting sponge may include any suitable disinfecting or other application-specific substance and may be made of any suitable material. Also, the cap may be single-shot molded or made by other suitable processes.

[0111] Additionally, the included pictorial drawings further depict non-limiting examples of the implementation of certain exemplary embodiments of the present invention and serve to explain the technology related thereto. Any specific or relative dimensions or measurements provided in the other drawings, such as those described above, are exemplary and are not intended to limit the scope or content of the inventive designs or methods as understood by a person skilled in the relevant art of the invention.

[0112] Other objects, advantages and salient features of the present invention will become apparent to those skilled in the art from the detailed description set forth below, which, taken in conjunction with the accompanying drawing figures, discloses illustrative embodiments of the invention.

Claims

1. 1. A method for disinfecting a needleless connector, the method comprising: removing a cover sealing an opening to an interior cavity of an antiseptic cap, said antiseptic cap comprising: a housing including a closed top, an essentially cylindrical sidewall, and an open bottom formed by said sidewall having an opening to an internal cavity within the housing for receiving a tip including a mating feature of a needleless connector; a disinfecting sponge disposed within the internal cavity, the internal cavity being sealed by the cover prior to use of the cap; the internal cavity includes at least one cap thread on an inner sidewall surface of the sidewall, the cap thread having a first major profile, a first minor profile, and a first pitch; removing the engaging mechanism, the engaging mechanism having a second major profile with a uniform outer diameter, a second minor profile, and a second pitch substantially equal to the first pitch; engaging the cap threads of the cap with the mating feature of the needleless connector; and forming at least one ventilation path from the internal cavity to the exterior of the housing between a surface of the cap thread and a surface of the mating mechanism of the needleless connector by a space surrounded by the cap thread and at least one of the second major contour and the second minor contour of the mating mechanism of the needleless connector when the cap thread engages with the mating mechanism of the needleless connector.

2. 2. The method of claim 1, wherein at least one of the major diameter, minor diameter, pitch, thread section profile, and number of threads of the cap thread does not correspond to at least one of the major diameter, minor diameter, pitch, thread section profile, and number of threads of the mating feature of the needleless connector, respectively.

3. 2. The method of claim 1, wherein the portion of the sidewall that forms the open bottom includes an inner sidewall surface that forms the opening to the internal 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.

4. the open bottom formed by the sidewall of the housing is non-flat such that there is an outlet space between a flat surface and the open bottom of the housing; 2. The method of claim 1, further comprising the step of venting the disinfecting sponge through the opening to the internal cavity, essentially around the exterior of the mating mechanism of the needleless connector and through the exit space toward the exterior of the housing.

5. the open bottom formed by the sidewall of the housing includes an irregular bottom inner sidewall surface having one or more divots configured such that the opening to the interior cavity does not form an airtight seal with an outer surface of the needleless connector; 2. The method of claim 1, further comprising: venting the disinfecting sponge through the opening to the internal cavity, essentially around the exterior of the mating mechanism of the needleless connector, and through at least one of the divots toward the exterior of the housing.

6. 6. The method of claim 5, wherein the housing includes a flared lower portion formed in the open bottom including the one or more divots regularly or randomly spaced along a bottom inner sidewall surface that defines the opening to the internal cavity.

7. the cap threads include an extended portion that extends below the open bottom formed by the sidewall such that when the cap threads mate with the needleless connector such that the extended portion contacts the top portion of the needleless connector, a relief space exists between a surface of the top portion of the needleless connector and the open bottom; 2. The method of claim 1, further comprising the step of venting the disinfecting sponge through the opening to the internal cavity, essentially around the exterior of the mating mechanism of the needleless connector and through the relief space toward the exterior of the housing.

8. the portion of the sidewall forming the open bottom includes a flared bottom portion having an inner sidewall surface forming the opening to the interior cavity such that when the needleless connector is securely engaged with the housing, the open bottom does not form an airtight seal with an outer surface of the needleless connector; 2. The method of claim 1, further comprising the step of venting the disinfecting sponge through the opening to the internal cavity, essentially around the exterior of the mating mechanism of the needleless connector, and between the inner sidewall surface of the flared bottom portion and the outer surface of the needleless connector, toward the exterior of the housing.

9. 2. The method of claim 1, wherein the open bottom formed by the sidewalls of the housing is essentially flat.

10. 2. The method of claim 1, wherein the open bottom formed by the sidewalls of the housing is non-planar such that there is an outlet space between a flat surface and the open bottom of the housing.

11. the internal cavity includes an upper region terminating in the closed top and a lower region terminating in the opening to the internal cavity; the lower region includes the cap threads; and The method of claim 1 , wherein the upper region includes a protrusion into the interior cavity configured to contact the sponge.

12. 9. The method of claim 8, wherein the sidewall includes an inner sidewall surface including a plurality of segments between the cap threads, each of the segments having a slope with respect to a longitudinal axis of the housing of the cap, and at least one of the segments forming the open bottom, the at least one of the segments extending away from the longitudinal axis to form the flared bottom portion.

13. the interior cavity includes an upper region that terminates within the closed top and a lower region that terminates within the opening to the interior cavity; and 9. The method of claim 8, wherein the inner sidewall surface includes a transition section having a straight or curved surface where 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 section in the lower region is greater than a cross-sectional area at a top of the transition section in the upper region.

14. 14. The method of claim 13, wherein the sponge is not displaced into the upper region when the cap threads engage with the mating feature of the needleless connector so that the sponge maintains contact with the needleless connector and remains away from the inner surface of the closed top.

15. the portion of the sidewall forming the open bottom includes a flared bottom portion having an inner sidewall surface forming the opening to the interior cavity such that when the needleless connector is securely engaged with the housing, the open bottom does not form an airtight seal with an outer surface of the needleless connector; the opening to the interior cavity formed by the inner sidewall surface of the flared bottom portion is essentially circular and includes an opening diameter; and the opening diameter is larger than a flange diameter of the needleless connector such that the opening diameter provides an air gap between the inner sidewall surface of the housing and the needleless connector; whereby the opening to the internal cavity includes the ventilation gap; 2. The method of claim 1, further comprising the step of venting the disinfecting sponge through the opening to the internal cavity, essentially around the exterior of the mating mechanism of the needleless connector and through the ventilation gap toward the exterior of the housing.

16. the internal cavity includes an upper region terminating in the closed top and a lower region terminating in the opening to the internal cavity; 9. The method of claim 8, wherein the sidewall includes an inner sidewall surface in the lower region including a plurality of segments between the cap threads, each of the segments having essentially the same slope with respect to a longitudinal axis of the housing of the cap, and at least one of the segments forming the open bottom, the at least one of the segments flaring away from the longitudinal axis to form the flared bottom portion.

17. 2. The method of claim 1, wherein the 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 to facilitate engagement with the mating feature of the needleless connector.

18. The method of claim 1 , wherein at least a portion of the at least one cap thread includes a non-engaging portion that does not engage the mating feature of the needleless connector.

19. The cap threads are at least one mating portion formed on at least a portion of the cap threads to facilitate mating with the mating feature of the needleless connector; and 10. The method of claim 1, further comprising at least one non-engaging portion that does not engage with the mating feature of the needleless connector.

20. 1. A method of storing caps, the method comprising attaching a plurality of caps to a strip, each cap of the plurality of caps comprising: a housing including a closed top, an essentially cylindrical sidewall, and an open bottom formed by said sidewall having an opening to an internal cavity within the housing for receiving a tip including a mating feature of a needleless connector; a disinfecting sponge configured within the interior cavity; and a removable cover sealing the opening to the internal cavity for sealing the sponge within the internal cavity prior to use of the cap; Including, the internal cavity includes at least one cap thread on an inner sidewall surface of the sidewall; the cap threads are sufficient to mate with the mating feature of the needleless connector; 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 at least one of a major diameter, a minor diameter, a pitch, a thread section profile, and a number of threads of the mating feature of the needleless connector, respectively; When the cap threads mate with the mating feature of the needleless connector, at least one ventilation path is formed from the internal cavity to the exterior of the housing between a surface of the cap threads and a surface of the mating feature of the needleless connector.

21. the strip includes the removable cover; The method includes attaching each cap of the plurality of caps to the removable cover with the removable cover included in the strip at the open bottom of each cap; 21. The method of claim 20, whereby each cap of the plurality of caps is peelable from the strip such that when peeled from the strip, a cover is removed from the opening to the internal cavity of the cap.

22. the strip is double-sided, including a first side opposite a second side; The method comprises: First, attaching at least one of the plurality of caps to the first side of the strip; second, attaching at least another one of the plurality of caps to the second side of the strip; 21. The method of claim 20, comprising:

23. 23. The method of claim 22, wherein the at least one of the caps and the at least another of the caps are attached to the strip at essentially the same longitudinal location on the strip.

24. the strip includes a plurality of prongs attached to and extending away from a surface of the strip; 21. The method of claim 20, wherein the method includes removably attaching each cap of the plurality of caps to the strip by connecting one of the prongs to an exterior surface of the cap.

25. 25. The method of claim 24, wherein the strip is double-sided, including a first side opposite a second side, at least one of the plurality of caps being attached to the first side by at least one of the plurality of prongs extending through the first side, and at least another one of the plurality of caps being attached to the second side by at least another one of the plurality of prongs extending through the second side.

26. 26. The method of claim 25, wherein the at least one of the prongs and the at least another of the prongs are attached to the strip at essentially the same longitudinal location on the strip.

27. the strip includes an attachment portion; 21. The method of claim 20, further comprising selectively positioning the strip on an IV pole by configuring the mounting portion of the strip on the IV pole.

28. 21. The method of claim 20, wherein the strip is essentially flat and includes a plurality of compartments separated by perforations in the strip, each of the compartments including at least one of the plurality of caps disposed thereon, whereby the perforations facilitate separation at the perforation of at least one of the compartments including the at least one cap disposed thereon.

29. the strip includes the removable covers for the plurality of caps disposed thereon; The method includes attaching each cap of the plurality of caps to the strip at the open bottom of the cap; 29. The method of claim 28, whereby each of the caps is peelable from the strip such that when peeled from the strip, the opening to the internal cavity of each of the caps is uncovered.

30. 30. The method of claim 28, wherein the strip is double-sided, including a first side opposite a second side, at least one of the plurality of caps being attached to the first side, and at least another one of the plurality of caps being attached to the second side.

31. 31. The method of claim 30, wherein the at least one of the caps and the at least another of the caps are attached to the strip at essentially the same longitudinal location on the strip.

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