Connector Coupling Assembly
The connector assembly with a pusher mechanism and stopwatch activation addresses the issue of accidental disconnection by securing the IV catheter until a threshold force is reached, ensuring secure retention and preventing leakage, and providing timely disconnection indication.
Patent Information
- Application Number
- JP2025522230
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-11-11
- Filing Date
- 2023-09-28
- Publication Date
- 2025-10-30
AI Technical Summary
Conventional IV catheter connectors often dislodge due to improper fixation and excessive forces, leading to accidental disconnection and disruption of medical fluid administration.
A connector assembly with a pusher mechanism and stopwatch activation that secures the connection until a predetermined threshold force is exceeded, then automatically disconnects and seals the flow path, preventing accidental dislodgement and leakage.
Ensures secure retention of the connector during normal use while allowing intentional removal, preventing catheter dislodgement and fluid leakage at higher forces, and providing timely indication of disconnection.
Smart Images

Figure 2025535903000001_ABST
Abstract
Description
[Technical Field]
[0001] This application claims priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 63 / 424,587, filed November 11, 2022, the disclosure of which is incorporated herein by reference in its entirety.
[0002] The present disclosure relates generally to connectors, and more particularly to self-sealing connectors configured to prevent accidental disconnection of a catheter from an access location. [Background technology]
[0003] Medical procedures often involve the infusion of medical fluids (e.g., saline or liquid medications) into a patient using intravenous (IV) catheters, which are connected to a source of fluid, such as an IV bag, through an arrangement of flexible tubing and fittings commonly referred to as an “IV set.” Often, the tubing or catheters are joined or secured together to allow fluid communication between various portions of the tubing or catheter.
[0004] In some applications, such tubing or catheters may become dislodged due to improper fixation and / or when the coupler is subjected to forces that exceed those it is designed to withstand. Summary of the Invention [Means for solving the problem]
[0005] In some embodiments described herein, a connector assembly includes a cover having an inner surface defining a cavity terminating at an open end of the cover and a luer portion extending through the open end into the cavity; a proximal connector disposed at least partially within the cavity of the cover, the proximal connector having an inner surface defining an entry port and defining the cavity of the proximal connector; a pusher mounted to the proximal connector, the pusher comprising a body portion including an outer surface, a proximal end and a distal end, and first and second pusher legs extending radially outward from opposite sides of the body portion at the proximal end of the body portion; and a luer portion of the cover. The connector includes a distal connector at least partially disposed within the cavity, and a stopwatch mounted on an outer surface of the cover and including at least one contact, wherein when the distal connector is coupled to the mating connector, the stopwatch abuts the first pusher leg so as to retract the at least one contact into the stopwatch, and when a force applied to the proximal connector exceeds a predetermined threshold and causes the pusher to translate proximally relative to the distal connector, the stopwatch moves away from the first pusher leg and the at least one contact extends proximally to activate a timer of the stopwatch.
[0006] Some embodiments include a cover having a proximal end, an outer surface, an inner surface defining a cavity terminating at the open end of the cover, and a luer portion extending through the open end into the cavity; a proximal connector disposed at least partially within the cavity of the cover, the proximal connector having an inlet port and an inner surface defining the cavity of the proximal connector, wherein a flow path extends from the inlet port through the luer portion to an outlet port of the luer portion; a pusher mounted on the proximal connector, the pusher having a body portion including an outer surface, an inner surface defining the cavity of the pusher, a proximal end, and a distal end with a plurality of protrusions extending radially outward from the body portion; and a pusher having opposing protrusions at the proximal end of the body portion. a pusher having first and second pusher legs extending radially outward from a side of the cover; and a distal connector disposed within a cavity of the cover and having first and second arms extending through the open end of the cover, the first and second arms being pivotally coupled to one another and slidably coupled to the pusher, with a proximal end portion of each of the first and second arms comprising a protrusion, wherein when a force applied to the proximal connector exceeds a predetermined threshold, a plurality of protrusions on the body portion disengage from the protrusions of the first and second arms, thereby allowing the pusher to translate proximally relative to the distal connector.
[0007] It is to be understood that various configurations of the subject technology will be readily apparent to those skilled in the art from the disclosure, and that various configurations of the subject technology have been shown and described by way of illustration. As will be understood, the subject technology is capable of other and different configurations, and its several details are capable of modifications in various other respects, all without departing from the scope of the subject technology. Accordingly, the summary, drawings, and detailed description are to be regarded as illustrative in nature, and not as restrictive.
[0008] The accompanying drawings are included to provide a further understanding, are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure, and together with the description, serve to explain the principles of the disclosed embodiments. [Brief explanation of the drawings]
[0009] [Figure 1] 1 is a diagram of an IV extension set including a connector assembly fluidly coupled to a catheter, according to some embodiments of the present disclosure. [Figure 2] 2 is a diagram of an IV extension set including the connector assembly of FIG. 1 detached from the catheter due to the application of a proximally directed force exceeding a predetermined threshold, according to some embodiments of the present disclosure. [Figure 3] FIG. 1 is an exploded perspective view of a connector assembly according to some embodiments of the present disclosure. [Figure 4] 4 is an assembled cross-sectional view of the connector assembly of FIG. 3 according to some embodiments of the present disclosure. [Figure 5] FIG. 4 is a first perspective view of the connector assembly of FIG. 3 according to some embodiments of the present disclosure. [Figure 6] FIG. 4 is a second perspective view of the connector assembly of FIG. 3 according to some embodiments of the present disclosure. [Figure 7] 4 is a cross-sectional view of the connector assembly of FIG. 3 prior to mating with a mating needleless connector according to some embodiments of the present disclosure. [Figure 8] 4 is a cross-sectional view of the connector assembly of FIG. 3 when coupled to a mating needleless connector according to some embodiments of the present disclosure. [Figure 9] FIG. 4 is a cross-sectional operational view of the connector assembly of FIG. 3 with the mating needleless connector disconnected, where a proximally directed force exceeding a predetermined threshold causes the distal connector to pivot open and seal the flow path, according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION
[0010] The disclosed connector assembly incorporates an inner surface defining a cavity, a cover having a luer portion extending into the cavity and through the distal end of the cover, a proximal connector disposed at least partially within the cavity of the cover, a pusher mounted to the proximal connector, a distal connector disposed at least partially within the cavity of the cover and including first and second arms extending through the open end of the cover, and a stopwatch mounted to the outer surface of the cover and including at least one contact. A flow path may extend from the inlet port through the luer portion to an outlet port of the luer portion. The proximal connector may have an inner surface defining the inlet port and defining the cavity of the proximal connector. The pusher may include a body portion and first and second legs extending radially outward from opposite sides of the body portion at the proximal end of the body portion.
[0011] In some embodiments, the distal connector may include first and second arms extending through the open end of the cover, pivotally coupled to one another, and slidably coupled to a pusher. When the distal connector is coupled to a mating connector, e.g., a needleless connector, a stopwatch may abut the first pusher leg to retract at least one contact into the stopwatch. When a force applied to the proximal connector exceeds a predetermined threshold, causing the pusher to translate proximally relative to the distal connector, the stopwatch may disengage from the first pusher leg, and at least one contact may extend or protrude proximally to activate a timer on the stopwatch. For example, when the pusher translates proximally relative to the distal connector, protrusions on the first and second arms of the distal connector may slide distally and completely out of engagement with the pusher, thereby allowing the first and second arms to pivot radially outward and release the mating connector. The mating connector may then be wiped or otherwise disinfected, and the connector assembly may then be replaced with a new, sterilized connector assembly.
[0012] The various embodiments of the connector assembly described herein are advantageous over conventional couplers and associated infusion systems in that they incorporate a stopwatch that is activated upon release or otherwise disconnection from the mating connector, allowing the stopwatch to enable a clinician or other medical professional to determine the exact moment / timing when disconnection occurs. Additionally, the various embodiments of the connector assembly described herein are advantageous over conventional couplers and associated infusion systems in that a withdrawal force exceeding a predetermined threshold would result in actual catheter dislodgement or disconnection, in that release or other disconnection from the mating connector would prevent excessive sounding of an alarm to alert the clinician to catheter 50 dislodgement and the potential resulting bleeding, medication leakage, and dislodgement.
[0013] In various embodiments, the connector assembly may further include a spring member mounted within the cavity of the proximal connector and a post disposed within the luer portion and extending longitudinally into the flow path from a proximal end of the spring member toward the outlet port of the luer portion. When the mating connector is coupled to the distal connector, the mating connector may exert a force to urge the multiple arms proximally, compressing the spring member and moving the closed end of the post away from the outlet port of the luer portion. When the first and second arms disengage from the pusher, the compressed spring expands and exerts a force on the post, moving the closed end of the post toward the outlet port of the luer portion to seal the outlet port, thereby closing the flow path and advantageously preventing microbial entry into the flow path. Further advantageously, the sealed outlet port may prevent medical fluid, e.g., IV fluid, from further exiting or otherwise spilling out of the flow path through the outlet port of the luer portion upon disconnection of the mating connectors.
[0014] The first and second arms of the distal connector are advantageously designed to release the mating needleless connector when a pulling force exceeding a threshold pulling force is applied, so that both the connector assembly (e.g., but not limited to, a Texium valve) and the mating connector (e.g., but not limited to, a Smartsite valve) automatically shut off when pulled apart, thereby preventing leakage or spillage of medical fluids upon accidental disconnection due to higher withdrawal forces exceeding a predetermined threshold force.
[0015] The detailed description set forth below is intended as a description of various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology. Similar components are labeled with the same element numbers for ease of understanding. Reference numbers may have a suffixed letter to indicate separate instances of common elements, while being generically referenced by the same number without the suffix.
[0016] While the following description is directed to connecting medical fittings for the administration of medical fluids using the disclosed couplers, it should be understood that this description is merely an example of use and is not intended to limit the scope of the claims. Various aspects of the disclosed couplers may be used in any application where it is desirable to securely connect various tubing and fittings.
[0017] The disclosed couplers overcome several problems found with certain conventional couplers. One problem with certain conventional couplers is that they may be improperly secured. Furthermore, during use, certain conventional couplers may be designed to release or disengage in response to a relatively small withdrawal force. For example, certain conventional couplers may release in response to withdrawal forces experienced when a patient turns in bed, when a patient catches the tubing or line on a bed rail, when a patient is moved to a different bed, when a pediatric patient fumbles, and / or when a confused adult patient withdraws their line. Indeed, the 2017 Vascular Access Association (AVA) Annual Meeting reported a 10% dislodgement rate per 1,000 patients fitted with peripheral IV catheters, translating to approximately 33 million dislodgements per year in the United States alone. Accidental or unintentional dislodgement of tubing, catheters, or fittings can interrupt the administration of medical fluids, making the use of certain conventional couplers undesirable.
[0018] Therefore, in accordance with the present disclosure, it would be advantageous to provide couplers and coupler / connector assemblies as described herein that allow for improved securement of fittings or connectors. The disclosed couplers and coupler / connector assemblies are constructed as described herein to allow for secure retention of the connector while allowing for intentional removal of the connector if desired.
[0019] FIG. 1 illustrates an IV extension set including a connector assembly 100 fluidly coupled to a catheter according to some embodiments of the present disclosure. FIG. 2 illustrates an IV extension set 1 including the connector assembly 100 of FIG. 1 disconnected from a catheter due to the application of a proximally directed force exceeding a predetermined threshold according to some embodiments of the present disclosure. As depicted, the IV set 1 may include a primary fluid system 15 and a secondary fluid system 25. An IV pump (not shown) may receive fluid from the primary fluid system 15 and the secondary fluid system 25 via a primary IV fluid line 5 and a secondary IV fluid line 7, and control and distribute the fluid therefrom to a patient via a catheter 50. In some embodiments, the primary fluid system 15 may include a primary fluid source or container, such as a primary intravenous (IV) fluid bag 10, which may contain or include a first medical fluid, such as saline or other medical fluid or medication, to be administered to a patient via the catheter 50. According to some embodiments, the secondary fluid system 25 may include a secondary fluid source or container, such as a secondary IV fluid bag 20, which may contain a second medical fluid, such as a medication or other secondary fluid to be delivered to a patient for treatment. In some embodiments, the second medical fluid may be different from the first medical fluid. However, various embodiments of the present disclosure are not limited to the above-listed configurations. In other embodiments, the first and second medical fluids may be the same.
[0020] According to various embodiments of the present disclosure, as illustrated in FIGS. 1 and 2 , primary IV fluid bag 10 may hold a primary fluid and be positioned at a lower axial position or height than secondary IV fluid bag 20. For example, primary IV fluid bag 10 may be hung from a hanging system or hanger, with secondary IV fluid bag 20 hanging above the primary IV fluid bag, and may be coupled to secondary fluid line 7, which is connected to primary line 5 via y-port adapter 8. As depicted, primary IV fluid line 5 may carry primary fluid from drip chamber 12 to outlet fluid line 9 via y-port adapter 8, and secondary IV fluid line 7 may carry secondary fluid from drip chamber 12 to outlet fluid line 9 via y-port adapter 8. Thus, y-port adapter 8 may fluidly couple or fluidly connect primary IV fluid line 5 and secondary IV fluid line 7 to outlet fluid line 9 to allow fluid to flow from primary fluid bag 10 and / or secondary fluid bag 20 to connector assembly 100 via outlet fluid line 9.
[0021] As depicted, the severable connector assembly 100 may be configured to selectively deliver a primary and / or secondary medical fluid to the catheter 50 via a mating connector 200 (e.g., a needleless connector 200). The IV extension set 1 may further include a mating luer 300 (e.g., a male luer connector 300) for coupling the connector assembly 100 to the tubing / outlet fluid line 9. As described in further detail below with reference to at least FIGS. 4 and 7-9 , a flow path 138 may be defined from the lumen of the fluid line 9 through the mating luer 300, the connector assembly 100, and the needleless connector 200. The first and / or second medical fluids may thus be delivered to the catheter assembly 50 via the flow path 138 and the extension tubing 45.
[0022] FIG. 3 illustrates an exploded perspective view of a connector assembly 100 according to some embodiments of the present disclosure. FIG. 4 illustrates an assembled cross-sectional view of the connector assembly 100 of FIG. 3 according to some embodiments of the present disclosure. With continued reference to FIGS. 1 and 2 , as illustrated in FIGS. 3 and 4 , the connector assembly 100 may include a cover 110 having an outer surface 109, an inner surface 108 defining a cavity 134 terminating at an open end 132 of the cover 110, and a luer portion 127 extending through the open end 132 of the cover 110 and into the cavity 134. The connector assembly 100 may further include a proximal connector 130 disposed at least partially within the cavity 134 of the cover 110. The proximal connector 130 may define an entry port 106 and may have an inner surface 105 defining the cavity 104 of the proximal connector 130. A spring member 118 may be mounted within the cavity 104 of the proximal connector 130 .
[0023] In some embodiments, the flow channel 138 may extend from the inlet port 106 through the luer portion 127 to the outlet port 142 of the luer portion 127. A post 140 may be disposed within the luer portion 127 and extend longitudinally within the flow channel 138 from the proximal end of the spring member 118 toward the outlet port 142 of the luer portion 127. In some embodiments, the post 140 may define the lumen 128 and may have an open end 144, an opposing closed end 146, and a passageway 148 through a sidewall between the open end 144 and the closed end 146. In some embodiments, the post 140 may include a seal 126 on an outer surface of the closed end 146 to prevent fluid flow through the outlet port 142 of the luer portion 127. As depicted, the post 140 may have multiple arms 122 extending from the post 140 along the outside of the luer portion 127 toward the outlet port 142. The post 140 may further include a pair of protrusions 141 extending radially outward from the outer surface on opposite sides of the post 140 .
[0024] In some embodiments, connector assembly 100 may further include a pusher 160 mounted to proximal connector 130. As depicted, pusher 160 may include a body portion 161 including an outer surface 162, a proximal end 165, and a distal end 164. Pusher 160 may further include first and second pusher legs 167 and 169 extending radially outward from opposite sides of body portion 161 at proximal end 165 of body portion 161. In some embodiments, body portion 161 of pusher 160 may further include a plurality of protrusions 166 extending radially outward from distal end 164 of body portion 161. In some embodiments, outer surface 162 of body portion 161 of pusher 160 may have a plurality of slots 170 at least partially recessed therein. As depicted, each slot 170 may extend distally from a respective one of pusher legs 167 and 169 to a respective one of protrusions 166 at distal end 164 of body portion 161. For example, a first slot 170 may extend distally from first pusher leg 167 to upper protrusion 166, and a second slot 170 may extend distally from second pusher leg 169 to lower protrusion 166.
[0025] According to various embodiments of the present disclosure, the connector assembly 100 may further include a distal connector 120 at least partially disposed within the cavity 134 of the cover 110, the distal connector 120 including first and second arms 113 and 115 disposed within the cavity 134 of the cover 110 and extending through the open end 132 of the cover 110. As depicted, the distal connector 120 may have an inner surface 123, and a proximal end portion of each of the first and second arms 113 and 115 may have a protrusion 121 extending radially inward from the inner surface 123. In some embodiments, the first and second arms 113 and 115 may be pivotally coupled to one another. For example, in some embodiments, the first and second arms 113 and 115 may each include a pair of hinge portions 116 having coupling holes 117. The hinge portions 116 and respective coupling holes 117 of the first and second arms 113 and 115 may be coaxially aligned such that pivot pins 119 may be inserted into the aligned coupling holes 117 on opposite sides of the first and second arms 113 and 115. Thus, the pair of hinge portions 116 of the first arm 113 may be rotatably coupled to the pair of hinge portions 116 of the second arm 115, thereby pivotally coupling the first and second arms 113 and 115 of the distal connector 120 to one another.
[0026] In some embodiments, the first and second arms 113 and 115 of the distal connector 120 may be slidably coupled to the pusher 160. For example, in a coupled configuration of the distal connector 120 and the pusher 160 (illustrated at least in FIG. 7 ), the protrusions 121 of the first and second arms 113 and 115 may be supported, seated, or otherwise disposed within corresponding slots 170 of the pusher 160. As depicted, in a coupled configuration of the distal connector 120 and the pusher 160, the protrusions 121 of the first and second arms 113 and 115 may be positioned within the slots 170 such that they abut or otherwise contact and engage the protrusions 166 of the pusher 160. As described in more detail below, the above-listed configurations are advantageous in that they prevent distal movement of the distal connector relative to the pusher when a proximally directed force below a predetermined threshold is applied to the proximal connector.
[0027] FIG. 5 illustrates a first perspective view of the connector assembly 100 of FIG. 3 according to some embodiments of the present disclosure. FIG. 6 illustrates a second perspective view of the connector assembly 100 of FIG. 3 according to some embodiments of the present disclosure. In some embodiments, the connector assembly 100 may further include a stopwatch 150 mounted to the outer surface 109 of the cover 110. As depicted, the stopwatch may include at least one contact 156 protruding proximally from a side surface 154 of the stopwatch 150 and a display portion 151 for illustrating the timer 153 of the stopwatch 150. While various embodiments of the present disclosure illustrate two contacts 156, various embodiments of the present disclosure are not limited to the above-listed configuration. In some embodiments, the at least one contact 156 may be one contact, or may be three or more contacts 156. In some embodiments, stopwatch 150 may include a light and / or buzzer indicator around exterior 152 of stopwatch 150 to provide a visual and / or audible indicator to a clinician or other medical professional that connector assembly 100 has been disconnected from mating connector 200. Stopwatch 150 may be a digital stopwatch with an internal battery to provide power. In some embodiments, the internal battery may be a panel battery that may power display 151 once stopwatch 150 is released from pusher 160.
[0028] 7-9 , when the distal connector 120 is coupled to the mating connector 200, the stopwatch 150 abuts the inner surface 168 of the first pusher leg 167 (as illustrated in FIG. 6 ) to retract the at least one contact 156 into the side surface 154 of the stopwatch 150. Furthermore, when a force (i.e., a proximally directed force) applied to the proximal connector 130 exceeds a predetermined threshold, causing the pusher 160 to translate proximally relative to the distal connector 120, the stopwatch 150 may move away from the pusher leg 167 and the at least one contact 156 may extend proximally to activate the timer 153 of the stopwatch 150. For example, when the pusher 160 translates proximally relative to the distal connector 120, the protrusions 121 of the first and second arms 111 and 113 of the distal connector 120 may slide distally along the slot before completely disengaging from the pusher 160.
[0029] The connector assembly 100 of the various embodiments described herein is advantageous over conventional couplers and associated infusion systems in that it incorporates a stopwatch that is activated when released or otherwise disconnected from the mating connector 200, allowing a clinician or other medical professional to determine the exact moment / timing when the disconnection occurred.
[0030] Figure 7 shows a cross-sectional view of the connector assembly of Figure 3 prior to mating with a mating needleless connector according to some embodiments of the present disclosure. Figure 8 shows a cross-sectional view of the connector assembly of Figure 3 when mated to a mating needleless connector according to some embodiments of the present disclosure. Figure 9 shows a cross-sectional operational view of a connector assembly having a disconnected mating needleless connector where a proximally directed force above a predetermined threshold causes the distal connector to pivot open and seal the fluid path according to some embodiments of the present disclosure.
[0031] With continued reference to FIGS. 1 and 2 , and with reference to FIGS. 7-9 , the operation of the connector assembly will be generally described. In operation, the connector assembly 100 may generally be coupled at its distal end to a mating or interconnector 200 and at its proximal end to a mating luer connector 300. In some embodiments, the mating or interconnector 200 may be a needleless connector, and the mating luer connector 300 may be a male luer connector. For example, in some embodiments, the mating connector 200 may be inserted into and coupled to the open end 125 of the distal connector 120, and the male luer connector 300 may be inserted into and coupled to the entry port 106 of the proximal connector 130. In some embodiments, the mating connector 200 may include threads 205 for mating with complementary threads 175 on the open end 125 of the distal connector 120.
[0032] FIG. 7 shows the connector assembly 100 prior to mating with the mating needleless connector 200, and FIG. 8 depicts the mated configuration of the distal connector 120 of the connector assembly 100 when either no force is applied to the proximal connector 130 or a force below a predetermined proximal threshold force (also referred to herein as a pull-out force) is applied. For example, the connector assembly 100 may be subjected to proximally directed pull-out forces as a result of a patient turning over in bed, a patient catching tubing or lines on a bed rail, a patient being moved to a different bed, a pediatric patient fiddling, and / or a confused adult patient tugging on their line. In some embodiments, the predetermined proximal threshold (pull-out) force may be approximately 2.268 kg (5 pounds (lbs)). However, various embodiments described herein are not limited to the configurations listed above, and in some instances, the predetermined proximal threshold (withdrawal) force may be greater than or less than 5 lbs. In some embodiments, the predetermined proximal threshold force may range from 3 lbs to 5 lbs, and in some embodiments, the threshold force may range from 4 lbs to 5 lbs.
[0033] According to various embodiments of the present disclosure, when subjected to a lower withdrawal force, for example, a force below a predetermined proximal threshold (withdrawal) force, the connector assembly 100 may be configured to retain the mating connector 200 within the distal connector 120 such that the flow path 138 remains open and medical fluid, for example, IV fluid, may be administered from the fluid line 9 (fluidly connected to the primary fluid bag 10 and the secondary fluid bag 20) into the catheter 50. Specifically, as illustrated in FIG. 8 , when the distal connector 120 is coupled to the mating connector 200, the closed end 146 of the post 140 (with the attached seal 126) may be moved away from the outlet port 142 of the luer portion 127, allowing flow through the flow path 138 via the luer portion 127.
[0034] As depicted, in a mating configuration between the mating connector 200 and the distal connector 120, the luer portion 127 may extend through the top surface 207 of the mating connector 200 and into the mating luer of the mating connector 200, displacing the flexible valve 204 of the mating connector 200. Thus, when the mating connector 200 is coupled to the distal connector 120, the mating connector 200 may exert a force to urge the plurality of arms 122 proximally, which may compress the spring member 118 and move the closed end 146 of the post 140 away from the exit port 142 of the luer portion 127. For example, as illustrated in FIG. 8 , the plurality of arms 122 and the post 140 may be urged away from the exit port 142 of the luer portion 127 by the top surface 207. In the open position, the closed end 146 of the post 140 is moved away from the outlet port 142 of the luer portion 127, thereby allowing medical fluid to flow through the passageway 148 between the outlet port 142 of the luer portion 127 and the lumen 128 of the post 140. As previously described above, when the mating connector 200 is coupled to the distal connector 120, the plurality of protrusions 166 on the body portion engage the protrusions 121 on the first and second arms 111 and 113, thereby preventing distal movement of the distal connector 120 relative to the pusher 160.
[0035] 9 illustrates a decoupled configuration of the mating connector 200 and distal connector 120 of the connector assembly 100 when a (withdrawal) force exceeding a predetermined proximal threshold is applied to the proximal connector 130. According to various embodiments of the present disclosure, upon receiving a higher (withdrawal) force, e.g., a (withdrawal) force exceeding the predetermined proximal threshold, the connector assembly 100 may be configured to release or otherwise decouple the mating connector 200 from within the distal connector 120, at which point the flow path 138 may close and medical fluid, e.g., IV fluid, may be discontinued from entering the elongated tubing 45 through the closed flow path 138. As previously discussed, in some embodiments, the predetermined proximal threshold (withdrawal) force may be approximately 2.268 kg (5 pounds (lbs)). For example, if a patient with catheter 50 inserted beneath their skin walks away from the infusion pump, or accidentally pulls on extension tubing 45 with a force exceeding 5 pounds (lbs), connector assembly 100 may automatically release or disconnect from mating connector 200, as described in further detail below, effectively closing off flow path 138 connecting first and second fluid bags 10 and 20 to the patient. The various embodiments of connector assembly 100 described herein are advantageous over conventional couplers and associated infusion systems, where a pull-out force exceeding a predetermined threshold would result in actual catheter dislodgement or disconnection, in that by releasing or otherwise disconnecting from mating connector 200, catheter 50 is prevented from dislodgement and excessive sounding of alarms intended to alert clinicians to the potential resulting bleeding, medication leakage, and dislodgement.
[0036] 9 , when a force applied to the proximal connector 130 exceeds a predetermined threshold, the plurality of protrusions 166 on the body portion 161 of the pusher 160 disengage from the protrusions 121 of the first and second arms 111 and 113, allowing the pusher 160 to translate proximally relative to the distal connector 120 and pivot the first and second arms 111 and 113 radially outward to decouple the mating connector 200 from the distal connector 120, as described in further detail below. For example, during operation when a proximal withdrawal force applied to the proximal connector 130 exceeds a predetermined threshold, the withdrawal force causes the plurality of protrusions 166 on the body portion 161 of the pusher 160 to disengage from the protrusions 121 of the first and second arms 111 and 113. When first and second arms 111 and 113 disengage from pusher 160, compressed spring 118 expands and exerts a force on post 140, moving closed end 146 of post 140 toward outlet port 142 of luer portion 127 to seal outlet port 142, thereby closing flow path 138 and advantageously preventing the entry of microorganisms into flow path 138. Further advantageously, sealed outlet port 142 may prevent medical fluid, e.g., IV fluid, from further exiting or otherwise spilling out of flow path 138 via outlet port 142 of luer portion 127 upon disconnection of mating connector 200.
[0037] As the post 140 moves distally, the protrusions 141 on the post 140 abut and push against (i.e., exert a distal force on) the protrusions 121 of the first and second arms 111 and 113, causing the first and second arms 111 and 113 to pivot radially outward and spread the open ends 125 of the distal connector 120 to release the mating connector 200. In addition to the expansion of the compressed spring 11, the disengagement of the first and second arms 111 and 113 from the pusher 160 causes the pusher 160 to translate proximally relative to the distal connector 120 and the cover 110 on which the stopwatch 150 is mounted, thereby moving the stopwatch 150 away from the pusher 160. 9 , side 154 of stopwatch 150 is spaced from inner surface 168 of first leg 167 of pusher 160, thereby allowing contacts 156 to extend proximally or otherwise protrude outward from side 154 to activate timer 153. Thus, upon radially outward pivoting of first and second arms 111 and 113 and release, disconnection, or otherwise detachment of mating connector 200 from the connector assembly, timer 153 may be advantageously activated to indicate the time and / or duration when the detachment occurred.
[0038] Thus, first and second arms 111 and 113 may be advantageously designed to release mating needleless connector 200 when a pulling force exceeding a threshold pulling force is applied to elongated tubing 45 and proximal connector 130. Thus, both connector assembly 100 (e.g., but not limited to, a Texium valve) and mating connector 200 (e.g., but not limited to, a Smartsite valve) may automatically shut off when pulled apart, thereby preventing (i) the ingress of microorganisms into flow path 138 and (2) the leakage or spillage of medical fluids upon accidental disconnection due to higher withdrawal forces above a predetermined threshold force. The above-listed configurations are advantageous over currently existing catheter removal devices or couplers, which are generally adhesive-based and may or may not only be capable of preventing catheter dislodgement at lower withdrawal forces. Such currently existing catheter removal devices or couplers may not prevent catheter dislodgement at higher pull-out forces, but instead may release in response to higher pull-out forces (e.g., greater than 5 lbs) experienced during a patient turning over in bed, a patient getting the tubing or line caught on a bed rail, a patient being moved to a different bed, a pediatric patient fiddling, and / or a confused adult patient tugging on their line.
[0039] According to various embodiments of the present disclosure, the first arm 111 and the second arm 113 of the distal connector 120 may be returned from the pivoted state illustrated in FIG. 9 to the non-pivoted state illustrated in FIG. 7 by pinching them together or otherwise applying oppositely directed forces to the first arm 111 and the second arm 113, causing the first arm 111 and the second arm 113 to pivot radially inward to their original state before pivoting outward.
[0040] In some embodiments, the connector assembly 100 may also be disconnected from the mating luer connector 300. The luer portion of the connector 300 as well as the mating connector 200 may then be wiped or otherwise disinfected. In some embodiments, the connector assembly 100 may be discarded and replaced with a new, sterilized connector assembly 100 without damaging or otherwise contaminating the fluid path. The connector assembly 100 may then be coupled to the mating luer connector 300 and the mating needleless connector 200.
[0041] In some embodiments, after sterilization of the mating connector 200, the mating connector 200 may then be coupled or connected to a new sterile connector assembly 100. The mating connector 200 may then be advanced toward the luer portion 127 of the distal connector 120. As the mating connector 200 is advanced toward the luer portion 127 of the distal connector 120, the luer portion 127 may advance into the interior of the mating connector 200 and compress the valve member 204 of the mating connector 200. As the luer portion advances further into the interior of the mating connector 200, the top surface 207 of the mating connector 200 may exert a force to urge the plurality of arms 122 proximally, which in turn may compress the spring member 118 and move the closed end 146 of the post 140 away from the exit port 142 of the luer portion 127, as illustrated in FIG. 8 . For example, the plurality of arms 122 and post 140 may be urged away from the exit port 142 of the luer portion 127 by the top surface 207. In the open position, the closed end 146 of the post 140 is moved away from the exit port 142 of the luer portion 127, thereby opening the flow path 138 and allowing medical fluid to flow through the lumen 128 and the passageway 148 of the post 140, through the exit port 142 of the luer portion 127, and into the mating connector 200. Thus, IV fluid is administered from the fluid line 9 to the catheter 50 via the new sterile connector assembly 100.
[0042] According to various embodiments of the present disclosure, when subjected to a lower withdrawal force, for example, a force below a predetermined proximal threshold (withdrawal) force, the connector assembly 100 may be configured to retain the mating connector 200 within the distal connector 120 such that the flow path 138 remains open and medical fluid, such as IV fluid, may be administered from the fluid line 9 (which is fluidly connected to the fluid bags 10 and 20) into the catheter 50. Specifically, when the distal connector 120 is coupled to the mating connector 200, the closed end 146 of the post 140 (with the attached seal 126) may be moved away from the outlet port 142 of the luer portion 127, allowing flow through the flow path 138 via the luer portion 127.
[0043] Examples of subject matter technology as clauses The subject technology is exemplified according to various aspects, for example, as described below. Various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and are not intended to limit the subject technology. Note that any of the dependent clauses may be combined in any combination and placed within a respective independent clause, e.g., clause 1 or clause 5. Other clauses may be presented in a similar manner.
[0044] Clause 1. A cover having an inner surface defining a cavity terminating at an open end of the cover and a luer portion extending through the open end into the cavity; a proximal connector disposed at least partially within the cavity of the cover, the proximal connector having an inner surface defining an entry port and defining the cavity of the proximal connector; a pusher mounted to the proximal connector, the pusher comprising a body portion including an outer surface, a proximal end and a distal end, and first and second pusher legs extending radially outward from opposite sides of the body portion at the proximal end of the body portion; and a distal connector disposed at least partially within the cavity of the cover. and a stopwatch mounted on an outer surface of the cover and including at least one contact, wherein when the distal connector is coupled to the mating connector, the stopwatch abuts against the first pusher leg so as to retract the at least one contact into the stopwatch, and when a force applied to the proximal connector exceeds a predetermined threshold and causes the pusher to translate proximally relative to the distal connector, the stopwatch moves away from the first pusher leg and the at least one contact extends proximally to activate a timer of the stopwatch.
[0045] Clause 2. A connector as described in Clause 1, wherein the distal connector comprises first and second arms disposed within a cavity in the cover and extending through the open end of the cover, the first and second arms pivotally coupled to each other and slidably coupled to the pusher.
[0046] Clause 3. A connector assembly as described in Clause 2, wherein the body portion of the pusher further comprises a plurality of protrusions extending radially outward from the distal end of the body portion, and wherein the proximal end portions of each of the first and second arms comprise protrusions, and when the distal connector is coupled to a mating connector, the plurality of protrusions on the body portion engage with the protrusions on the first and second arms to prevent distal movement of the distal connector relative to the pusher.
[0047] Clause 4. A connector assembly as described in clause 3, wherein when a force applied to the proximal connector exceeds a predetermined threshold, the multiple protrusions on the body portion disengage from the protrusions on the first and second arms, allowing the pusher to translate proximally relative to the distal connector and the first and second arms to pivot radially outward to disconnect the mating connector from the distal connector.
[0048] Clause 5. A connector assembly as described in Clause 3, wherein the outer surface of the body portion of the pusher has a plurality of slots at least partially recessed therein, each slot extending distally from a respective one of the first and second pusher legs to a respective one of the protrusions at the distal end of the body portion, and when a force exceeding a predetermined threshold is applied to the proximal connector and the pusher translates proximally relative to the distal connector, the protrusions of the first and second arms of the distal connector slide along the slot.
[0049] Clause 6. The connector assembly of clause 2, further comprising a spring member mounted within the cavity of the proximal connector, the spring member having a flow path extending from the inlet port through the luer portion to the outlet port of the luer portion of the cover, and a post disposed within the luer portion and extending longitudinally within the flow path from the distal end of the spring member toward the outlet port of the luer portion.
[0050] Clause 7. The connector assembly of clause 6, wherein when the distal connector is coupled to the mating connector, the closed end of the post is moved away from the outlet port of the luer portion to allow flow through the flow path via the luer portion.
[0051] Clause 8. The connector assembly of clause 7, further comprising a plurality of arms extending from the post along the exterior of the luer portion toward the exit port.
[0052] Clause 9. The connector assembly of clause 8, wherein when the mating connector is coupled to the distal connector, the mating connector exerts a force to urge the plurality of arms proximally, compressing the spring member and moving the closed end of the post away from the exit port of the luer portion.
[0053] Clause 10. The connector assembly of clause 8, wherein when the distal connector is disconnected from the mating connector, the closed end of the post seals the outlet port of the luer portion to prevent fluid from exiting the flow path through the outlet port of the luer portion.
[0054] Clause 11. The connector assembly of clause 10, wherein when a force applied to the proximal connector exceeds a predetermined threshold, the spring member expands and exerts a force on the post to move the closed end of the post toward the exit port of the luer portion to seal the exit port.
[0055] Clause 12. A connector assembly as described in clause 11, wherein the post includes a pair of protrusions extending radially outward from opposite sides of the post, and when a force applied to the proximal connector exceeds a predetermined threshold, causing the spring member to expand and exert a force on the post, the pair of protrusions abut and push against the protrusions of the first and second arms, thereby pivoting the first and second arms radially outward and spreading the open ends of the distal connector to release the mating connectors.
[0056] Clause 13. The connector assembly of clause 1, wherein the mating connector comprises a needleless connector.
[0057] Clause 14. A cover having a proximal end, an outer surface, an inner surface defining a cavity terminating at the open end of the cover, and a luer portion extending through the open end into the cavity; a proximal connector disposed at least partially within the cavity of the cover, the proximal connector having an inlet port and an inner surface defining the cavity of the proximal connector, wherein a flow path extends from the inlet port through the luer portion to an outlet port of the luer portion; a pusher mounted on the proximal connector, the pusher having a body portion including an outer surface, an inner surface defining the cavity of the pusher, a proximal end, and a distal end with a plurality of protrusions extending radially outward from the body portion; and a proximal end of the body portion facing the body portion at the proximal end of the body portion. a pusher having first and second pusher legs extending radially outward from a side of the cover; and a distal connector disposed within a cavity of the cover and having first and second arms extending through the open end of the cover, the first and second arms being pivotally coupled to one another and slidably coupled to the pusher, and a proximal end portion of each of the first and second arms comprising a protrusion, wherein when a force applied to the proximal connector exceeds a predetermined threshold, a plurality of protrusions on the body portion disengage from the protrusions of the first and second arms, thereby allowing the pusher to translate proximally relative to the distal connector.
[0058] Clause 15. A connector assembly as described in clause 14, wherein when the distal connector is coupled to the mating connector, the protrusions on the body portion engage with the protrusions on the first and second arms to prevent distal movement of the distal connector relative to the pusher, and when a force applied to the proximal connector exceeds a predetermined threshold, the first and second arms pivot radially outward to decouple the mating connector from the distal connector.
[0059] Clause 16. The connector assembly of clause 15, further comprising a stopwatch mounted on an outer surface of the cover, the stopwatch abutting an inner surface of the first pusher leg when the distal connector is coupled to the mating connector.
[0060] Clause 17. A connector assembly as described in clause 16, wherein the stopwatch has at least one contact protruding proximally from a side of the stopwatch, and when the stopwatch abuts the inner surface of the first pusher leg, the at least one contact is retracted into the stopwatch.
[0061] Clause 18. The connector assembly of clause 17, wherein the stopwatch comprises a display portion for illustrating a timer of the stopwatch, and when a force applied to the proximal connector exceeds a predetermined threshold and the pusher translates proximally relative to the distal connector, the stopwatch moves away from the pusher and at least one contact extends proximally to activate the timer.
[0062] Clause 19. The connector assembly of clause 16, further comprising a spring member mounted within the cavity of the proximal connector and a post disposed within the luer portion and extending longitudinally within the flow path from the distal end of the spring member toward the outlet port of the luer portion.
[0063] Clause 20. The connector assembly of clause 19, wherein when the distal connector is coupled to the mating connector, the closed end of the post is moved away from the outlet port of the luer portion to allow flow through the flow path via the luer portion.
[0064] Clause 21. The connector assembly of clause 20, further comprising a plurality of arms extending from the post and extending along an exterior of the luer portion toward the exit port.
[0065] Clause 22. The connector assembly of clause 21, wherein when the mating connector is coupled to the distal connector, the mating connector exerts a force to urge the plurality of arms proximally, compressing the spring member and moving the closed end of the post away from the exit port of the luer portion.
[0066] Clause 23. A connector assembly as described in clause 21, wherein when the distal connector is disconnected from the mating connector, the closed end of the post seals the outlet port of the luer portion to prevent fluid from exiting the flow path through the outlet port of the luer portion.
[0067] Clause 24. The connector assembly of clause 23, wherein when a force applied to the proximal connector exceeds a predetermined threshold, the spring member expands and exerts a force on the post to move the closed end of the post toward the exit port of the luer portion to seal the exit port.
[0068] Clause 25. A connector assembly as described in clause 24, wherein the post includes a pair of protrusions extending radially outward from opposite sides of the post, and when a force applied to the proximal connector exceeds a predetermined threshold, causing the spring member to expand and exert a force on the post, the pair of protrusions abut and push against the protrusions of the first and second arms, thereby pivoting the first and second arms radially outward and spreading the open ends of the distal connector to release the mating connectors.
[0069] Clause 26. A connector assembly as described in clause 14, wherein the outer surface of the body portion of the pusher has a plurality of slots at least partially recessed therein, each slot extending distally from a respective one of the first and second pusher legs to a respective one of the protrusions at the distal end of the body portion, and when a force exceeding a predetermined threshold is applied to the connector and the pusher translates proximally relative to the distal connector, the protrusions of the first and second arms of the distal connector slide along the slot.
[0070] This disclosure is provided to enable those skilled in the art to practice the various aspects described herein. The disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.
[0071] Reference to an element in the singular is not intended to mean "one and only one" unless specifically so stated, but rather "one or more." The term "some" refers to one or more unless specifically so stated. Masculine pronouns (e.g., he) also include feminine and neuter pronouns (e.g., she and she), and vice versa. Headings and sub-headings, if any, are used merely for convenience and do not limit the invention.
[0072] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" should not necessarily be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.
[0073] The use of phrases such as "aspects" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. Disclosure relating to one aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such an embodiment is essential to the subject technology or that such an embodiment applies to all configurations of the subject technology. Disclosure relating to one embodiment may apply to all embodiments, or to one or more examples. An embodiment may provide one or more examples. A phrase such as an embodiment may refer to one or more examples, and vice versa. A phrase such as "configuration" does not imply that such an embodiment is essential to the subject technology or that such an embodiment applies to all configurations of the subject technology. Disclosure relating to one configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. A phrase such as a configuration may refer to one or more configurations, and vice versa.
[0074] In one aspect, unless stated otherwise, all measurements, values, ratings, locations, dimensions, sizes and other specifications set forth in this specification, including the following claims, are approximate and not exact, and in one aspect, they are intended to have a reasonable range consistent with the function to which they relate and that which is customary in the art to which they pertain.
[0075] In one aspect, the term "coupled" or the like may refer to being directly coupled. In another aspect, the term "coupled" or the like may refer to being indirectly coupled.
[0076] Terms such as "top," "bottom," "front," and "rear," when used in this disclosure, should be understood to refer to an arbitrary reference frame rather than the conventional gravity reference frame. Thus, top, bottom, front, and rear surfaces may extend upward, downward, diagonally, or horizontally in the gravity reference frame.
[0077] Various items may be arranged differently (e.g., placed in a different order or partitioned in a different manner) without departing from the scope of the subject technology. All structural and functional equivalents comparable to the elements of the various embodiments described throughout this disclosure, known or later known to those skilled in the art, are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. § 112, sixth paragraph, unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, unless the element is recited using the phrase "step for." Furthermore, to the extent the terms "comprise," "have," and the like are used, such terms are intended to be inclusive in the same manner as the term "comprising" is construed when used as a transitional term in the claims.
[0078] The title, background, summary, brief description of the drawings, and abstract of the disclosure are hereby incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as a limiting description. They are presented with the understanding that they will not be used to limit the scope or meaning of the claims. Additionally, in the Detailed Description, the description provides illustrative examples, and it will be appreciated that various features have been grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure should not be interpreted as reflecting an intention that claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in fewer than all features of a single disclosed configuration or operation. The following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as separately claimed subject matter.
[0079] The claims are not intended to be limited to the embodiments described herein, but are to be accorded the full scope consistent with the claims' language and encompass all legal equivalents. Nonetheless, none of the claims are intended to, and should not be construed to, encompass subject matter that does not meet the requirements of 35 U.S.C. §§ 101, 102, or 103.
Claims
1. a cover having an interior surface defining a cavity terminating at an open end of the cover and a luer portion extending through the open end into the cavity; a proximal connector disposed at least partially within the cavity of the cover, the proximal connector having an interior surface defining an entry port and defining a proximal connector cavity; a pusher mounted to the proximal connector, a body portion including an outer surface, a proximal end, and a distal end; a pusher comprising first and second pusher legs extending radially outward from opposite sides of the body portion at the proximal end thereof; a distal connector at least partially disposed within the cavity of the cover; a stopwatch mounted on the outer surface of the cover and including at least one contact, when the distal connector is coupled to a mating connector, the stopwatch abuts the first pusher leg to retract the at least one contact into the stopwatch; When a force applied to the proximal connector exceeds a predetermined threshold, causing the pusher to translate proximally relative to the distal connector, the stopwatch moves away from the first pusher leg and the at least one contact extends proximally to activate a timer of the stopwatch.
2. The distal connector 2. The connector assembly of claim 1, comprising first and second arms disposed within the cavity of the cover and extending through the open end of the cover, the first and second arms pivotally coupled to one another and slidably coupled to the pusher.
3. 3. The connector assembly of claim 2, wherein the body portion of the pusher further comprises a plurality of protrusions extending radially outward from the distal end of the body portion, and wherein a proximal end portion of each of the first and second arms comprises a protrusion, and when the distal connector is coupled to the mating connector, the plurality of protrusions of the body portion engage with the protrusions of the first and second arms to prevent distal movement of the distal connector relative to the pusher.
4. 4. The connector assembly of claim 3, wherein when a force applied to the proximal connector exceeds the predetermined threshold, the plurality of protrusions on the body portion disengage from the protrusions of the first and second arms, allowing the pusher to translate proximally relative to the distal connector and the first and second arms to pivot radially outward to decouple the mating connector from the distal connector.
5. 4. The connector assembly of claim 3, wherein an outer surface of the body portion of the pusher includes a plurality of slots at least partially recessed therein, each slot extending distally from a respective one of the first and second pusher legs to a respective one of the protrusions at the distal end of the body portion, and wherein when the force exceeding the predetermined threshold is applied to the proximal connector and the pusher translates proximally relative to the distal connector, the protrusions of the first and second arms of the distal connector slide along the slot.
6. a spring member mounted within the cavity of the proximal connector, the spring member having a flow path extending from the inlet port through the luer portion to an outlet port of the luer portion of the cover; 3. The connector assembly of claim 2, further comprising a post disposed within said luer portion and extending longitudinally within said flow passage from a distal end of said spring member toward said exit port of said luer portion.
7. 7. The connector assembly of claim 6, wherein when the distal connector is coupled to the mating connector, the closed end of the post is moved away from the outlet port of the luer portion to allow flow through the flow path via the luer portion.
8. The connector assembly of claim 7 further comprising a plurality of arms extending from said post along the outside of said luer portion toward said exit port.
9. 9. The connector assembly of claim 8, wherein when the mating connector is coupled to the distal connector, the mating connector exerts a force to urge the plurality of arms proximally, compressing the spring member and moving the closed end of the post away from the exit port of the luer portion.
10. 9. The connector assembly of claim 8, wherein when the distal connector is disconnected from the mating connector, the closed end of the post seals the outlet port of the luer portion to prevent fluid from exiting the flow path through the outlet port of the luer portion.
11. 11. The connector assembly of claim 10, wherein when the force applied to the proximal connector exceeds the predetermined threshold, the spring member expands and exerts a force on the post to move the closed end of the post toward the exit port of the luer portion to seal the exit port.
12. 12. The connector assembly of claim 11, wherein the post includes a pair of protrusions extending radially outward from opposite sides of the post, and when the force applied to the proximal connector exceeds the predetermined threshold, causing the spring member to expand and exert a force on the post, the pair of protrusions abut the protrusions on the first and second arms and push against the protrusions on the first and second arms, causing the first and second arms to pivot radially outward and spread the open ends of the distal connector to release the mating connector.
13. The connector assembly of claim 1 , wherein the mating connector comprises a needleless connector.
14. a cover having a proximal end, an outer surface, an inner surface defining a cavity terminating at the open end of the cover, and a luer portion extending through the open end into the cavity; a proximal connector disposed at least partially within the cavity of the cover, the proximal connector having an interior surface defining an inlet port and defining a proximal connector cavity, a flow path extending from the inlet port through the luer portion to an outlet port of the luer portion; a pusher mounted to the proximal connector, a body portion including an outer surface, an inner surface defining a cavity of the pusher, a proximal end, and a distal end including a plurality of projections extending radially outward from the body portion; a pusher comprising first and second pusher legs extending radially outward from opposite sides of the body portion at the proximal end thereof; a distal connector disposed within the cavity of the cover and comprising first and second arms extending through the open end of the cover, the first and second arms pivotally coupled to one another and slidably coupled to the pusher, a proximal end portion of each of the first and second arms comprising a protrusion; a connector assembly wherein, when a force applied to the proximal connector exceeds a predetermined threshold, the plurality of protrusions on the body portion disengage from the protrusions on the first and second arms, thereby allowing the pusher to translate proximally relative to the distal connector.
15. 15. The connector assembly of claim 14, wherein when the distal connector is coupled to a mating connector, the protrusions on the body portion engage the protrusions on the first and second arms to prevent distal movement of the distal connector relative to the pusher, and when the force applied to the proximal connector exceeds the predetermined threshold, the first and second arms pivot radially outward to decouple the mating connector from the distal connector.
16. 16. The connector assembly of claim 15, further comprising a stopwatch mounted on the outer surface of the cover, the stopwatch abutting an inner surface of the first pusher leg when the distal connector is coupled to the mating connector.
17. 17. The connector assembly of claim 16, wherein the stopwatch includes at least one contact protruding proximally from a side of the stopwatch, and wherein the at least one contact is retracted into the stopwatch when the stopwatch abuts the inner surface of the first pusher leg.
18. 18. The connector assembly of claim 17, wherein the stopwatch comprises a display portion for illustrating a timer of the stopwatch, and when the force applied to the proximal connector exceeds the predetermined threshold and the pusher translates proximally relative to the distal connector, the stopwatch moves away from the pusher and the at least one contact extends proximally to activate the timer.
19. a spring member mounted within the cavity of the proximal connector; 17. The connector assembly of claim 16, further comprising a post disposed within said luer portion and extending longitudinally within said flow passage from a distal end of said spring member toward said exit port of said luer portion.
20. 20. The connector assembly of claim 19, wherein when the distal connector is coupled to the mating connector, the closed end of the post is moved away from the outlet port of the luer portion to allow flow through the flow path via the luer portion.