Connector cap

A connector caps that can reduce risk of accidentally removing the cap include a locking feature where outer housing is designed to prevent removal of the cap unless a downward force is applied to the cap with counter clockwise rotation. Structural elements making up the cap locking feature can be optimized or varied, for example to require application of more or less force, more or less downward movement, more or less rotational movement, and variations of other characteristics to facilitate intentional removal and/or to prevent unintentional removal of the cap from the needleless connector, and/or to facilitate securing of the cap on the needleless connector. Optionally, a needleless connector cap can include an outer housing providing holes or openings or vents such that air can pass through if the cap becomes lodged in air passage way.

TECHNICAL FIELD

Generally, exemplary embodiments of the present disclosure relate to the fields of medical caps, including medical connector caps, and in particular connector caps and/or disinfection caps for uses with IV needleless connectors.

BACKGROUND

In developed markets, when utilizing an IV catheter, a needleless connector will typically be used to close off the system and then subsequently accessed to administer medication or other necessary fluids via the catheter to the patient. Various conventional caps for closing off a needleless connector while not in use have been known for some time. In order to decrease Catheter-related bloodstream infection (CRBSI) cases disinfection caps were originally disclosed in U.S. Patent Publication No. 2007/011233 which issued as U.S. Pat. No. 8,740,864 (the entire disclosures of both of which are incorporated herein by reference), and introduced on the market. Connector caps, including disinfection caps, such as disclosed in the U.S. Pat. No. 8,740,864 are illustrated inFIGS.1and2herein, where cap1includes a disinfecting pad2and a lid3, and cap4includes a disinfecting pad5and lid7, as well as threads6on its inner circumference8to interlock with needleless connector hub. On the other hand, other convention caps may have similar features but exclude the disinfecting pad. Disinfection caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines and early indications are that caps will also be incorporated into the 2016 Infusion Nurses Standards (INS) guidelines.

Further improved designs for connector caps, including disinfection caps, are disclosed in related U.S. patent applications Ser. Nos. 15/408,278 and 15/408,187, both filed on Jan. 17, 2017 (the entire disclosures of both of which are incorporated herein by reference).

Unfortunately, conventional caps, with or without the disinfecting feature, on the market today may pose choking hazard for example due to their relatively small size and ease of removal from a needles connector. Consequently, needleless connector caps are typically not used in situations where they may be inadvertently removed, for example by a child, causing potential safety concerns. At this time, there is no needleless connector cap device on the market that addresses such potential safety concerns, for example by locking the cap to prevent inadvertent removal of the cap from a needleless connector.

Hence there is a need for a safety locking integration with needleless connector caps.

SUMMARY

The matters exemplified in this description are provided to assist in a comprehensive understanding of exemplary embodiments of the disclosure. 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 disclosure. Also, descriptions of well-known functions and constructions are omitted for clarity and conciseness.

As would be readily appreciated by skilled artisans in the relevant art, while descriptive terms such as “lock”, “hole”, “tip”, “hub”, “thread”, “sponge”, “protrusion”, “slope”, “wall”, “top”, “side” and others are used throughout this specification to facilitate understanding, it is not intended to limit any components that can be used in combinations or individually to implement various aspects of the embodiments of the present disclosure.

Exemplary embodiments of the disclosure provide connector caps that can reduce the risk of accidentally (or, for example, by a child) removing the cap by including a locking feature. Optionally, in any exemplary implementation of the disclosed embodiments, a needleless connector cap includes an outer housing that is designed to prevent removal of the cap unless a downward force is applied to the cap with counter clockwise rotation.

Optionally, according to further exemplary implementations of any of the disclosed embodiments, configuration of structural elements making up the cap locking feature can be optimized or varied, for example to require application of more or less force, more or less downward movement, more or less rotational movement, and variations of other characteristics to facilitate intentional removal and/or to prevent unintentional removal of the cap from the needleless connector, and/or to facilitate securing of the cap on the needleless connector.

Optionally, according to yet further exemplary implementations of any of the disclosed embodiments, a connector cap includes an outer housing that is further designed to provide holes or openings or vents such that air can pass through if the cap becomes lodged in air passage way.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, a connector cap comprises: an inner housing comprising a first top wall, an essentially cylindrical first sidewall, an open bottom formed by said first sidewall with an opening to an inner cavity within said inner housing for receiving a hub of a needleless connector, and at least one cap thread on an inner sidewall surface of said first sidewall, said cap thread being sufficient to interlock with a mating feature of said hub of said needleless connector; an outer housing comprising a second top wall configured above said first top wall, and an essentially cylindrical second side wall configured to essentially surround said first sidewall; and a safety interface comprising a first portion configured on an outer surface of said first top wall, and a second portion configured on an inner surface of said second top wall. The safety interface transfers a rotational movement of said outer housing to a rotational movement of said inner housing in the same rotational direction when said first top wall and said second top wall are urged toward each other and said first portion and said second portion engage.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, the first portion of said safety interface comprising at least one first protrusion, and the second portion of said safety interface comprises at least one second protrusion.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, at least one of said first protrusion and said second protrusion comprises a slope surface and a vertical surface.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, said first protrusion comprises a first vertical surface essentially perpendicular to said outer surface of said first top wall and a first slope surface at an acute angle to said outer surface of said first top wall, and said second protrusion comprises a second vertical surface essentially perpendicular to said inner surface of said second top wall and a second slope surface at an acute angle to said inner surface of said second top wall.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, said inner housing comprises an inner housing retaining feature, and said outer housing comprises an outer housing retaining feature, said inner housing retaining feature and said outer housing retaining feature are configured to engage to secure said outer housing on said inner housing and allow rotational movement of said outer housing with respect to said inner housing when said first portion of said safety interface and said second portion of said safety interface are not engaged.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, said inner housing retaining feature comprises a protrusion on an outer surface of said first sidewall of said inner housing, and said outer housing retaining feature comprises a recess in an inner surface of said second sidewall of said outer housing, said protrusion and said recess are configured to engage to secure said outer housing on said inner housing.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, said inner housing retaining feature comprises a first latching protrusion on an outer surface of said first top wall of said inner housing, and said outer housing retaining feature comprises a second latching protrusion on an inner surface of said second top wall of said outer housing, said first latching protrusion and said second latching protrusion are configured to latch to secure said outer housing on said inner housing.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, said second top wall of said outer housing comprises at least one opening extending through said top wall allowing air to pass through said outer housing.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, said inner housing and said outer housing are configured to allow said air passing through said at least one opening to pass between an inner surface of said outer housing and an outer surface of said inner housing.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, an application of a rotational force to said outer housing causes said rotational movement of said outer housing, and said second portion of said safety interface to engage said first portion of said safety interface to transfer said rotational movement of said outer housing to said rotational movement of said inner housing to threadably rotate said inner housing to interlock said cap thread with said mating feature of said hub of said needleless connector.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, application of an axial force to said outer housing in a direction of said inner housing facilitates said second portion of said safety interface to engage that first portion of said safety interface.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, continuous application of an axial force to said outer housing in a direction of said inner housing causes said second portion of said safety interface to engage that first portion of said safety interface in an interference fit, and application of a rotational force to said outer housing causes said rotational movement of said outer housing, and said second portion of said safety interface to continue to engage said first portion of said safety interface to transfer said rotational movement of said outer housing to said rotational movement of said inner housing to threadably rotate said inner housing to remove said cap thread from said mating feature of said hub of said needleless connector.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, a disinfection sponge can be configured within said inner cavity, and a removable cover can be provided sealing said opening to said inner cavity to seal said sponge within said inner cavity prior to use of said cap.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, the cap thread does not correspond to the mating feature of the needleless connector.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, at least one of a major diameter, a minor diameter, a pitch, a thread section profile, and a number of threads of said cap thread does not correspond to said mating feature of said hub.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, at least one cap thread on said inner sidewall surface of said sidewall comprises a protrusion formed on a least a portion of said cap thread to facilitate said interlocking with said mating feature of said needleless connector.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, at least a portion of said at least one cap thread comprises a non-engaging portion that does not engage said mating feature of said needleless connector.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, said cap thread comprises at least one interlocking portion formed on a least a portion of said cap thread to facilitate said interlocking with said mating feature of said needleless connector, and at least one non-engaging portions that does not engage said mating feature of said needleless connector.

Optionally, according to yet further exemplary implementations of the disclosed embodiments, the cap thread comprises a first start thread path wherein the first start thread path has a major profile, a minor profile, a pitch, and a first thread section profile, at least a second start thread path wherein the second start thread path has a major profile, a minor profile, a pitch, and a second thread section profile, where the first thread section profile and the second thread section profile are different.

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

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

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

This matters exemplified in this description are provided to assist with a comprehensive understanding of exemplary embodiments with reference to the accompanying drawing figures. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the exemplary embodiments described herein can be made within the scope of appended claims without departing from their full scope and equivalents. Also, descriptions of well-known functions and constructions are omitted for clarity and conciseness. Likewise, certain naming conventions, labels and terms as used in the context of the present disclosure are non-limiting and provided only for illustrative purposes to facilitate understanding of exemplary implementations of the exemplary embodiments

Referring toFIGS.3A-6, according to exemplary embodiments of the present disclosure a safety locking connector cap10comprises an outer housing20which includes a top wall22and a sidewall26, an inner housing30which includes a top wall32and a sidewall36with an opening37into inner cavity38and one or more threads31on inner sidewall surface33of sidewall36, a peel sealing film40which seals opening, a disinfecting member50, such as an IPA soaked sponge, and a sealing surface60, which can be constituted by a surface of a rim of an open bottom of inner housing30.

Cavity38of inner housing30receives a tip of a needleless connector9after the peel sealing film40is removed or when the peal sealing film is pierced, and threadably secures the tip of needleless connector9within cavity38, one or more threads31being sufficient to interlock with a mating feature of a hub or tip of needleless connector9as described for example in related U.S. patent applications Ser. Nos. 15/408,278 and 15/408,187, both filed on Jan. 17, 2017.

Referring for example toFIGS.3A and3B, in an exemplary implementations of the embodiments of the present disclosure, inner housing30is disposed within outer housing20such that sidewall26essentially surrounds sidewall36, and top wall22essentially covers top wall32. A safety interface100comprises a first portion70that can be configured on an outer surface34of top wall32of inner housing30as a ratchet feature comprising one or more protrusions72such as a tooth or teeth having a first slope surface74and a first vertical surface76, and a second portion80that can be configured on an inner surface24of top22of outer housing20as a ratchet feature comprising one or more protrusions82such as a tooth or teeth having a second slope surface84and a second vertical surface86. The first vertical surface76can be essentially perpendicular to the outer surface34, and the first slope surface74can be at an acute angle to the outer surface34. On the other hand, the second vertical surface86can be essentially perpendicular to the inner surface24, and the second slope surface84can be at an acute angle to the inner surface24.

Safety interface100is configured such that first portion70and second portion80do not engage unless the outer surface34is sufficiently near the inner surface24such that protrusions72and82can make sufficient contact.

According to a further exemplary implementation of the embodiments of the present disclosure as illustrated in the example ofFIG.3B, a retaining interface to secure outer housing20with respect to inner housing30can be implemented for example as follows. An outer surface39of sidewall36of inner housing30can include an inner housing retaining feature such as a protrusion (or a skirt, or a flange)110, and an inner surface29of sidewall26of outer housing20can include an outer housing retaining feature such as a recess120. Protrusion110and recess120are configured to engage, for example at respective first contact surface112of protrusion110and second contact surface122of recess120, such that outer housing20is secured on inner housing30while allowing rotational movement of outer hosing20with respect to inner housing30, as illustrated for example with reference to examples ofFIGS.5and6.

Retaining interface secures outer housing20with respect to inner housing30while allowing sufficient axial movement of the outer surface34with respect to the inner surface24such that on the one hand protrusions72and82do not necessarily contact each other when outer housing20is rotated with respect to inner housing30, and on the other hand protrusions72and82make sufficient contact with each other to transfer rotational movement of outer housing20to inner housing30.

According to another further exemplary implementation of the embodiments of the present disclosure as illustrated in detail in the example ofFIG.3C, a retaining interface to secure outer housing20with respect to inner housing30can be optionally implemented in addition to, or instead of, the retaining interface shown inFIG.3B, for example as follows. An outer surface34of top wall32of inner housing30can include an inner housing retaining feature such as a latching protrusion130, and an inner surface24of top wall22of outer housing20can include an outer housing retaining feature such as a corresponding latching protrusion120. Protrusion130and protrusion120are configured to engage, for example by retaining rim132of protrusion130latching an extended skirt122of protrusion120, such that outer housing20is secured on inner housing30while allowing rotational movement of outer hosing20with respect to inner housing30, as illustrated below with reference to examples ofFIGS.5and6.

Referring for example toFIG.4A-4C, according to exemplary embodiments of the present disclosure, outer housing of a safety locking connector cap10is further designed to prevent a choking hazard by providing holes or openings such that air can pass through if the cap becomes lodged in an airway passage, for example a human throat.

As illustrated in the examples ofFIGS.4A and4B, any exemplary implementations of the embodiments of the present disclosure can optionally provide one or more openings90, such as openings92,94, and/or96, in top wall22of outer housing20, which allows air200to pass through the outer housing20for example between the inner surface of outer housing20and outer surface of inner housing30as diagrammatically illustrated in the example ofFIG.4B. The number, size and/or shape of the openings92,94and/or96can vary to ensure sufficient air passage, for example to meet safety concerns, as well as to avoid interference with the operation and/or functionality of the safety interface100.

While the example ofFIGS.3A and4Adiagrammatically illustrates an implementation where both protrusion110and recess120are optionally formed as continuous 360-degree features of respective inner housing30and outer housing20, according to exemplary embodiments of the present disclosure at least one or both of the protrusion110and recess120can be optionally formed as partial features. For example as illustrated inFIG.4Cby a cross-sectional bottom view of inner housing30, instead of a continuous 360-degree feature, protrusion110can comprise multiple protruding 10-degree portions114centered at 90 degree intervals on outer surface39of sidewall36. On the other hand, for example, instead of a continuous 360-degree feature, recess120can have one more gaps124as illustrated inFIG.4Dby a cross-sectional bottom view of outer housing20, which can also facilitates further prevention of a choking hazard by providing air passage if the cap becomes lodged in an airway passage. When forming at least one or both of the protrusion110and recess120as partial features, sizes and/or shapes of portion114and/or gaps124can be varied as appropriate and/or desired while ensuring outer housing20is properly configured with respect to inner housing30to ensure proper operation and/or functionality of the safety interface100.

Referring toFIGS.5and6, according to exemplary implementations of the embodiments of the present disclosure, securing cap10onto a needleless connector9is illustrated inFIG.5diagrammatically showing application of axial force171causing axial movement of top22of outer housing20toward top32of inner housing30and a rotational force170causing rotational movement (for example, in a clock-wise direction as may be required to threadably secure cap10onto needleless connector9) of outer housing20. The axial movement of top22toward top32reduces the distance between first portion70and second portion80of safety interface100allowing first portion70and second portion80to engage upon application of rotational force170. On the other hand, removing cap10from a needless connector9is illustrated inFIG.6diagrammatically showing application of axial force173causing axial movement of top22of outer housing20toward top32of inner housing30and a rotational force172causing rotational movement (for example, in a counter clock-wise direction as maybe required to remove a threadably-secured cap10from needleless connector9) of outer housing20.

As illustrated in the example ofFIG.5, according to an exemplary implementation of the embodiments of the present disclosure, application of force171with force170causes one or more first protrusions72having a first vertical surface76and respective one or more second protrusions82having a second vertical surface86to engage when oppositely facing essentially vertical surfaces76and86make contact, resulting in a transfer of the rotation of outer housing20to inner housing30such that inner housing30rotates in the same rotational direction as outer housing20to threadably rotate the inner housing onto needleless connector9to interlock cap thread31with any mating feature of the hub or tip of needleless connector9to secure cap10onto needleless connector9.

As illustrated in the example ofFIG.6, according to an exemplary implementation of the embodiments of the present disclosure, continuous application of force173with force172causes one or more first protrusions72having a first surface74and respective one or more second protrusions82having a second surface84to engage when oppositely facing surfaces74and84make contact resulting in a transfer of the rotation of outer housing20to inner housing30such that inner housing30rotates in the same rotational direction as outer housing20to threadably rotate off of needleless connector9to release thread31from any mating feature of the tip or hub of needleless connector9to thereby remove cap10from needleless connector9.

According to an exemplary implementation, force171may not need to be applied as an external force (or applied as a force of a relatively small magnitude) since free axial movement of outer housing20with respect to inner housing30may result in outer housing20moving toward inner housing30simply due to gravity based on positions of cap10with respect to needleless connector9. On the other hand, force173may need to be applied as an external force of a relatively greater magnitude to ensure engagement of one or more of first protrusions72with one or more respective second protrusions82by, for example, interference fit of respective surfaces74and84. For example, the slope and shape of respective surfaces74and84can be varied to adjust the amount of axial force173required to create sufficient interference fit of respective surfaces74and84such that protrusions72and82do not slip with respect to each other but engage to transfer the rotation of outer housing20to inner housing30. For example, an enhanced safety can be optionally achieved by increasing amount of axial force required to engage first portion70and second portion80in order to threadably rotate inner housing30off of needleless connector9to remove cap10from needleless connector9.

According to exemplary implementations of the embodiments of the present disclosure, outer housing30having the safety features described above with reference toFIGS.3-6can be optionally implements with any and all of the disinfectant caps having various features and designs described in Applicant's co-pending US patent applications Nos. U.S. patent applications Ser. Nos. 15/408,278 and 15/408,187, both filed on Jan, 17, 2017, for example by modifying outer surface of the housings of the disinfectant caps disclosed therein as shown in an illustrative example ofFIGS.7A and7B.

Referring toFIGS.7A and7B, a cross thread disinfecting cap300has housing302comprising: a closed top322; an essentially cylindrical sidewall304with an outer sidewall surface320; and an open bottom324with an opening326to an inner cavity328within housing302for receiving tip of a needleless connector. The bottom324formed by sidewall304of housing302is not flat such that space370exists between a flat surface310and bottom324of cap300. The inner cavity328can accommodate an alcohol soaked disinfection sponge380and has threads340on inner sidewall surface330of sidewall304. The diameter (major diameter345and/or minor diameter346) of threads340of the cap300may not correspond to the thread of a needleless connector. According to exemplary implementation of the present disclosure, outer sidewall surface320of housing302can be modified to include a protrusion110, as a continuous 360-degree features or as one or more protrusions114, and outer surface34of top322can be modified to include one or more second protrusions72. An outer housing20can be shaped and configured with respect to sidewall320and top322of what becomes an inner housing30to form a safety interface100as illustrated in the examples ofFIGS.3-6.

While the present disclosure has been shown and described with reference to certain exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the embodiments of the present disclosure. For example, a disinfection sponge can comprise any suitable disinfecting or other application-specific substance, and can be made of any suitable material. Also, the inner and/or the outer housing of the cap can be single shot molded, or made by other suitable process. Furthermore, any of the features or elements of any exemplary implementations of the embodiments of the present disclosure as describes above and illustrated in the drawing figures can be implemented individually or in any combination(s) as would be readily appreciated by skilled artisans without departing from the spirit and scope of the embodiments of the present disclosure.

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

Other objects, advantages and salient features of the disclosure will become apparent to those skilled in the art from the details provided, which, taken in conjunction with the annexed drawing figures, disclose exemplary embodiments of the disclosure.