Separable Connector

Abstract

A method for selecting a separation connector device for attachment to a needleless connector of an intravenous (IV) line is provided. The method includes providing a needleless connector for attachment to the separation connector. The needleless connector includes a push-out force associated with the needleless connector. The method further includes identifying a push-out force to be applied by the needleless connector and identifying a desired range of separation forces associated with separating a first portion of the IV line from a second portion of the IV line. The method further includes selecting a separation connector device including a housing and a separation component configured to be detached from the housing when a separation force is applied to the device, such that the sum of the separation force and the push-out force is within the desired range of separation forces.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a Patent Cooperation Treaty (PCT) application claiming the benefit of U.S. Patent Application No. 18 / 097,254, filed January 15, 2023, entitled "BREAKAWAY CONNECTOR," which is incorporated herein by reference in its entirety. This application is a continuation-in-part of U.S. Patent Application No. 17 / 884,391, filed August 9, 2022, which also claims the benefit of U.S. Provisional Patent Application No. 63 / 231,020, filed August 9, 2021.

[0002] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT Not applicable.

[0003] FIELD OF THE INVENTION The present invention relates to devices and methods for fluid line connectors for medical and veterinary applications, and in particular to breakaway connectors that are attached to needleless connectors on intravenous fluid lines. [Background technology]

[0004] Conventional devices and methods for fluid line disconnection connectors generally include two housings joined together. When the two housings are disconnected, the fluid path through the connector is interrupted, and valves within each housing are operable to stop fluid flow on each side upon a disconnection event. Conventional devices and methods utilizing such configurations are used in a variety of applications, for example, for intravenous (IV) medical lines that include soft, flexible tubing placed within a vein (usually in the hand or arm). When a sufficient amount of tension is applied to the line, the connectors separate, and valves in each connector component block fluid flow to prevent leakage.

[0005] In many medical applications, and particularly in peripheral IV lines, healthcare providers are increasingly implementing needleless connectors for clinician and patient protection. Needleless connectors provide an access port to an IV line without the need for needle insertion for fluid delivery. As an alternative to needle insertion, needleless connectors include a patient-side luer fitting with a seal, which may be opened or pierced by a corresponding injection-side luer fitting or syringe. The seal receives the injection-side fitting in sealed engagement, thereby establishing a fluid flow path between the injection-side component and the needleless connector of the patient-side conduit device. The seal may be a septum-type seal, an accordion seal, a compressible sheath, a push seal, or any other suitable seal known in the art for needleless engagement.

[0006] Needleless connectors allow for quick connection and disconnection without the need for needles for fluid delivery. When the injection fitting is removed from the needleless connector, a seal in the needleless connector automatically closes to prevent fluid leakage from the patient conduit assembly. Thus, the patient-side needleless connector includes an available seal that acts as a check valve that, when open, allows fluid to flow into the patient conduit and, when closed, prevents outflow. These types of needleless connectors have been rigorously designed to protect against contamination and are easily cleanable to sterilize the external interface elements and prevent the introduction of microorganisms into the fluid pathway.

[0007] As described above, when a sufficient amount of tension is applied to the conduit, the connectors will separate. In many medical applications, it will be desirable (or clinically necessary) for the connectors to separate at a clinically acceptable range of tension. For example, to protect the clinician and patient, it will be important that the connectors do not separate when the tension is too small (e.g., during typical or otherwise expected body movements, conduit adjustments, etc.). Likewise, it will be important that the connectors do separate when the tension is just right (e.g., during forceful movements that would cause damage or other problems if the connectors remained connected).

[0008] Conventional fluid line disconnect connectors have two valves (one on each component side of the disconnect mechanism), which are generally not optimized for use with needleless connectors. This is because such configurations, when installed (e.g., attached, engaged, etc.) on a needleless connector, essentially include three valves. These three valves include the connector's injection-side valve, the connector's outlet-side valve, and the needleless connector's seal. This type of configuration unnecessarily includes an intermediate valve, leading to a bulky and oversized assembly at the injection site. Therefore, it is desirable to improve disconnect connector devices so that engagement is more efficient in size, scale, and operation, while at the same time providing disconnection within a desirable range of tension for patient and clinician safety.

[0009] What is needed are improved devices and methods for using breakaway connectors in fluid applications, particularly for use with needleless connectors in IV lines in medical and veterinary applications. Summary of the Invention [Means for solving the problem]

[0010] The present disclosure relates to separation connector devices and methods for fluid lines. In some embodiments, the disclosure provides a method for selecting a separation connector device to attach to a needleless connector of an intravenous (IV) line attached to a patient. The method includes identifying a desired range of push-out forces associated with the needleless connector and a separation force associated with separating a first portion of the IV line from another portion of the IV line. The method further includes selecting a separation connector device including a housing and a separation component configured to detach from the housing when a separation force is applied to the device, such that the sum of the separation force and the push-out force is within the desired range of separation forces.

[0011] For example, when a separation force is applied to the separation connector itself, the separation component is removed from the housing and shell of the device. Conversely, when the device is installed on a needleless connector, the needleless fitting applies a push-out force to the device, pushing the housing away from the needleless fitting and its attached separation component. Overall, when a threshold tension is applied to the separation connector, the needleless connector and device separation component are detached together from the housing and shell of the device. As soon as this occurs, a valve within the device blocks inflow fluid flow, and a seal on the needleless connector blocks outflow from the patient conduit assembly.

[0012] By utilizing a step of identifying the push-out force of the needleless connector, it is possible to select a separation connector device that includes an appropriate separation force, so that the threshold tension required for the separation force, as a result of the sum of the separation force and the push-out force, falls within the desired range of separation force.

[0013] In another embodiment, the present disclosure provides a method of using a separation connector device. The method includes providing a separation connector including a housing and a separation component removably secured to the housing. The separation connector includes a separation force associated with removing the housing from the separation component. The method further includes providing a needleless connector including a seal. The method further includes installing the separation connector on the needleless connector. When the separation connector is installed on the needleless connector, the needleless connector applies an extrusion force to the housing, and the sum of the extrusion force and the extrusion force is within a desired range of separation forces associated with separating the housing from the needleless connector.

[0014] In another embodiment, the present disclosure provides a separation connector device including a separation connector. The separation connector has a housing, a fixed cannula, and a separation component removably secured to the housing. The device further includes a single valve disposed within the fixed cannula. The separation component includes a socket configured to engage with the needleless connector, whereby the needleless connector applies an extrusion force to the housing. The separation connector includes a separation force associated with removing the separation component from the shell. The sum of the separation force and the extrusion force is within a desired range of separation forces associated with separating the shell from the needleless connector.

[0015] Various other features and advantages of the present disclosure will be set forth in the following description and the accompanying drawings. [Brief explanation of the drawings]

[0016] [Figure 1] 1 shows a perspective view of an embodiment of a separation connector apparatus according to the present disclosure; [Figure 2] 2 illustrates a perspective cross-sectional view of the embodiment of the separation connector device of FIG. 1 with the axially movable cannula in a disengaged position. [Figure 3] 2 illustrates a perspective cross-sectional view of the embodiment of the separation connector device of FIG. 1 with the axially movable cannula in an engaged position. [Figure 4]1 shows a perspective exploded view of an embodiment of a detachable connector device configured to be installed on a needleless connector according to the present disclosure. [Figure 5] 1 shows a perspective view of an embodiment of a detachable connector device installed on a needleless connector according to the present disclosure. [Figure 6] 1A and 1B show cross-sectional views of an embodiment of a breakaway connector device configured to be installed in a needleless connector. [Figure 7] 1A-1C show cross-sectional perspective views of an embodiment of a detachable connector device installed on a needleless connector. [Figure 8] 1 shows a cross-sectional perspective view of an embodiment of a detachable connector device with the detachment component and needleless connector removed from the device. [Figure 9] 10 shows a perspective view of another embodiment of a separation connector device according to the present disclosure; [Figure 10] 10 shows a cross-sectional perspective view of the embodiment of the separation connector device of FIG. 9. [Figure 11] 10 shows a cross-sectional perspective view of another embodiment of a separation connector device according to the present disclosure; [Figure 12] 10 shows a perspective view of another embodiment of a separation connector device according to the present disclosure; [Figure 13] 10 shows a perspective view of another embodiment of a separation connector device according to the present disclosure; [Figure 14] 1 illustrates a perspective view of an embodiment of a separate component including a battery, a visual indicator, and an audible indicator. [Figure 15] 1 shows a cross-sectional view of an embodiment of a separation connector device including an axially movable cannula, a compressible sheath, and a battery housing containing a battery, and including a pull tab for activating an electronic circuit powered by the battery. [Figure 16] 1A and 1B show cross-sectional views of an embodiment of a breakaway connector device configured to be installed in a needleless connector. [Figure 17] 1A-1C show cross-sectional perspective views of an embodiment of a detachable connector device installed on a needleless connector. [Figure 18] 1A and 1B show cross-sectional views of an embodiment of a breakaway connector device configured to be installed in a needleless connector. [Figure 19]1A-1C show cross-sectional perspective views of an embodiment of a detachable connector device installed on a needleless connector. [Figure 20] 1A and 1B show cross-sectional views of an embodiment of a breakaway connector device configured to be installed in a needleless connector. [Figure 21] 1A-1C show cross-sectional perspective views of an embodiment of a detachable connector device installed on a needleless connector. [Figure 22] 1 shows a cross-sectional perspective view of an embodiment of a detachable connector device with the detachment component and needleless connector removed from the device. [Figure 23] 1 shows a perspective view of an embodiment of a kit for attaching a separation connector device to a needleless connector. DETAILED DESCRIPTION OF THE INVENTION

[0017] While the following provides detailed descriptions of making and using various embodiments of the invention, it should be understood that the invention provides many applicable inventive concepts that can be embodied in a variety of specific contexts. The specific embodiments described herein are merely illustrative of specific ways to make and use the invention and do not delimit the scope of the invention. Those skilled in the art will recognize that there are various equivalents to the specific devices and methods described herein. Such equivalents are considered to be within the scope of the invention and are covered by the claims.

[0018] In the drawings, for the sake of clarity, not all reference numbers are included in every drawing. Furthermore, positional terms such as "upper," "lower," "side," "top," "bottom," etc. refer to the device in the orientation shown in the drawings. As will be appreciated by those skilled in the art, the device may be in other orientations when in use.

[0019] 1, the present disclosure provides a breakaway connector device 10 for attachment to a fluid line. Device 10 includes an input side 12 and an output side 14. Input side 12 may also be referred to as the pump side if the device is coupled to an infusion pump. Output side 14 may also be referred to as the patient side if the device is coupled to a patient's IV line. Input fitting 16, in some embodiments, includes a male or female luer fitting.

[0020] A socket 18 disposed on the output side 14 of the device 10 includes a cavity or recess shaped to accommodate insertion of a needleless connector of a patient's tubing set (e.g., the needleless connector 100 depicted in FIG. 4 ). Accordingly, the device 10 may be placed (e.g., attached, engaged, etc.) on the needleless connector 100. An axially movable cannula 20 projects from the device 10 toward the socket 18 and is positioned to engage a seal on the needleless connector 100. A first fitting 22 disposed on the output side 14 of the socket 18, in some embodiments, includes a female Luer fitting. The first fitting 22 is configured to engage a corresponding fitting on the needleless connector 100 to secure the needleless connector 100 to the device 10. A device window 24 is defined in the device 10 adjacent the socket 18. The device window 24 allows access to the socket 18 for manipulating the needleless connector 100 when the needleless connector 100 is received in the socket 18.

[0021] 2-3, partial cross-sectional views of the device 10 are shown according to some embodiments. As shown in FIG. 2, the axially movable cannula 20 includes an open bore 26 defined axially therein from end to end. The bore 26 allows fluid to flow through the axially movable cannula 20. The axially movable cannula 20 has an input end directed toward the input side 12 and an output end directed toward the output side 14. The input side of the axially movable cannula 20 includes a stem 28 having a tapered or narrowed radial profile, according to some embodiments.

[0022] Axially movable cannula 20 is housed in fixed cannula 32 of housing 30. Fixed cannula 32 forms a cylindrical sleeve having an internal channel, with axially movable cannula 20 located at least partially within the internal channel of fixed cannula 32. Axially movable cannula 20 is axially movable within device 10 by translating back and forth within fixed cannula 32 of housing 30. A valve chamber 34 is defined within fixed cannula 32 at the input end of axially movable cannula 20. In some embodiments, an input seal 36 is defined between stem 28 and fixed cannula 32, allowing stem 28 to slide axially relative to fixed cannula 32 without fluid leakage. A valve (e.g., valve 60 depicted in FIG. 6 ) is disposed in valve chamber 34. In some embodiments, valve 60 is a check valve. Valve 60 may be in a variety of forms, such as, but not limited to, an earplug valve, an orchid valve, a duckbill valve, or any other suitable valve known in the art.

[0023] In use, once the needleless connector 100 is mated, the axially moveable cannula 20 may be pushed axially away from the needleless connector 100, causing the stem 28 to translate toward the valve chamber 34 and engage the valve housed in the valve chamber 34. Engagement of the stem 28 of the axially moveable cannula 20 with the valve 60 opens the valve 60, thereby allowing fluid to travel through the inlet 19, enter the axially moveable cannula 20, and enter the needleless connector 100.

[0024] An example of the axial translation of the axially movable cannula 20 is shown in the positional relationship of the axially movable cannula 20 in FIGS. 2-3. In some embodiments, a valve chamber wall 37 is defined within the fixed cannula 32 on the input side of the valve chamber 34. The wall 37 provides a mechanical stop for the valve 60 to prevent the valve 60 from sliding away from the axially movable cannula 20 upon activation of the axially movable cannula 20. According to some embodiments, the wall 37 includes an opening or drilled hole that allows fluid flow from the inlet 19 into the bore 26 of the axially movable cannula 20. As will be described in more detail below, the axially movable cannula can be separated from the needleless connector 100 (a "detachment event"). When a detachment event occurs, the cannula is urged toward the output side, sliding away from the valve chamber and returning to the position shown in FIG. 2.

[0025] Referring to FIG. 4, the apparatus 10 is shown positioned to be installed in a needleless connector 100, according to some embodiments. The needleless connector 100 may be any conventional needleless device, such as a B. Braun Caresite, B. Braun Ultrasite, BD Q-Syte, BD MaxPlus, BD MaxZero, ICU Med MicroClave, ICU Neutron, Baxter One-Link, RyMed Invision Plus, or any other suitable needleless connector known in the art. In some embodiments, the needleless connector 100 includes an interface 102 that includes a seal 108 (according to various configurations, as shown in FIGS. 16-21 ). By way of example, the seal 108 may be a septum-style seal, an accordion seal, a compressible sheath, a push seal, or any other suitable seal known in the art of needleless engagement. The needleless connector 100 may also include a second fitting 103, such as a male or female Luer fitting configured to mate with a corresponding first fitting 22 on the device 10. The needleless connector 100 may also include a body 104 and a conduit interface 106 extending from the needleless connector 100 toward the patient. As will be described in more detail below with reference to Figures 16-21, the device 10 can accommodate a variety of needleless connector 100 configurations, and thus the embodiment of the needleless connector 100 shown in Figure 4 (as well as Figures 5-8 described below) is intended to be merely a non-limiting example of the present disclosure.

[0026] 5-7, according to some embodiments, the needleless connector 100 is directly joined to the separation device 10. Referring specifically to FIG. 5, the engagement can be viewed through the device window 24. The device window 24 also allows the user to manually twist or rotate the needleless connector 100 if necessary to engage a threaded luer fitting between the components.

[0027] 6-7, before the device 10 is installed in the needleless connector 100, the interface 102 is positioned directly opposite the output end of the axially movable cannula 20. From this position, the second fitting 103 engages a corresponding feature on the first fitting 22, thereby causing the axially movable cannula 20 to penetrate the interface 102 while the stem 28 advances into the valve chamber 34, activating and opening the valve 60. This dual action of the sliding of the axially movable cannula 20 simultaneously or nearly simultaneously opens the seal 108 of the needleless connector 100 and the valve 60 located in the valve chamber 34.

[0028] 6, in some embodiments, the axially movable cannula 20 includes a flange 21 that projects radially from an outer surface of the axially movable cannula 20 that is outboard of the fixed cannula 32. The flange 21 provides an axial stop for the interface 102 or other structural feature on the needleless connector 100. When the structure on the needleless connector 100 engages the flange 21, relative movement between the axially movable cannula 20 and the needleless connector 100 stops, and the axially movable cannula 20 is pushed by the needleless connector 100 toward the valve chamber 34. As the stem 28 passes the seal 36, the stem 28 engages the valve 60, opening the valve 60.

[0029] In some embodiments, the axially movable cannula 20 includes a barb 23 that protrudes from the portion of the axially movable cannula 20 that is housed within the fixed cannula 32. The barb 23 provides an axial stop against movement of the axially movable cannula 20 away from the valve 60. When the needleless connector 100 is not engaged with the device 10, the axially movable cannula 20 is biased away from the valve 60, and the barb 23 engages the channel stop 38 to prevent the axially movable cannula 20 from sliding too far out the open end of the internal channel of the fixed cannula 32.

[0030] 8, the device 10 is shown detached from the needleless connector 100, according to some embodiments. When a threshold tension associated with a detachment event (e.g., tension sufficient to cause a detachment event) is applied to the IV line, the needleless connector 100 and detachment component 50 can be detached together from the shell 40 and housing 30. Immediately after the detachment event, the axially movable cannula 20 automatically extends away from the valve 60 in the valve chamber 34. This occurs due to the force of the valve 60 pushing against the axially movable cannula 20 or due to a coil spring or other biasing member in the fixed cannula 32. After detachment, the detachment component 50 is completely separated from the shell 40.

[0031] In some embodiments, one or more protrusions 52 extend from the separation component 50 away from the needleless connector 100. The protrusions 52 act as a shield to prevent contamination of the interface 102 of the needleless connector 100 by mechanically blocking access to the needleless connector 100. After a separation event, the separation component 50 can be carefully removed from the needleless connector 100 by releasing the threaded luer connection between the separation component 50 and the needleless connector 100.

[0032] The threshold tension associated with a separation event can be finely tuned by controlling the component geometry between the separation component 50 and the shell 40 and the mechanical engagement therebetween. For example, in some embodiments, the shell 40 includes one or more fixation arms 42 extending toward the separation component 50. Each fixation arm 42 includes a flexible tip 44 angled radially away from the fixation cannula 32. In another embodiment, the flexible tip 44 may be angled radially toward the fixation cannula 32, which would accomplish the same function in an inverse configuration. Each fixation arm 42 and flexible tip 44 may have an individual stiffness defined by material composition, thickness, shape, and orientation angle, among other parameters. Each fixation arm 42 can be deflected toward the fixation cannula 32 during a separation event as the flexible tip 44 slides past a corresponding bevel 56 on the separation component 50, or can be deflected away from the fixation cannula 32 in an inverse configuration. The angle of inclination of ramp 56 also contributes to the tension required to disengage separation component 50 from device 10, and therefore contributes to the threshold tension associated with a separation event.

[0033] In some embodiments, a right-angled wall 58, oriented approximately perpendicular to the longitudinal direction of the apparatus 10, blocks the tip 44 if the device is attempted to be reassembled from the configuration shown in Figure 8. This feature provides an anti-reconnect feature that prevents the separation component 50 from being reinserted into the shell 40. This feature maintains sterility and requires the user to install a new sterile device after a separation event.

[0034] In some embodiments, one or more beveled windows 54 (e.g., slots) align with one or more corresponding openings 39 in housing 30 (shown in FIG. 1 ), thereby forming one or more keyholes that allow access to locking arms 42. This keyhole access allows for the insertion of a tool that depresses locking arms 42, allowing tips 44 to overcome walls 58 when separation component 50 is initially installed in shell 40 during manufacturing. On the one hand, this design prevents a user from deflecting locking arms 42 in an attempt to reconnect a used device (e.g., after a separation event).

[0035] 9-11 , according to some embodiments, device 10 includes fixed cannula 32, which is covered by a compressible sheath 200. Compressible sheath 200 may be an accordion-style compressible sheath molded from a flexible material (e.g., plastic, silicone, polymer, or elastomer). Compressible sheath 200 includes a seal 202, which in some embodiments may be a split septum-style seal. Seal 202 is biased to a closed position. When needleless connector 100 is installed in device 10, interface 102 engages seal 202 and pushes compressible sheath 200 rearward over fixed cannula 32, opening seal 202 and allowing fluid to pass through fixed cannula 32 and into needleless connector 100. 10 , when needleless connector 100 is installed on device 10, the distal end of compressible sheath 200 penetrates interface 102, thereby deforming and opening seal 108. In such embodiments, compressible sheath 200 may be sized and shaped to provide sufficient strength and resilience to directly engage interface 102. In other embodiments, compressible sheath 200 may not be sized and shaped to provide sufficient strength and resilience to directly engage interface 102. In such cases, interface 102 may push compressible sheath 200 back over fixation cannula 32 such that seal 202 remains open but compressible sheath 200 does not mechanically engage seal 108. In response, the fixed cannula 32 (at this point directly engaged with the interface 102 by the compressible sheath 200 being pushed rearward from above the fixed cannula 32) can simultaneously (or nearly simultaneously) penetrate the interface 102, deforming and opening the seal 108.

[0036] Upon a separation event, compressible sheath 200 resiliently returns to its original shape, covering fixation cannula 32 and closing seal 202 to stop flow from fixation cannula 32. In some embodiments, compressible sheath 200 includes a sheath flange 206 that extends radially from the base of compressible sheath 200. Sheath flange 206, according to some embodiments, is clamped between shell 40 and housing 30 to fix the axial position of compressible sheath 200 on fixation cannula 32. Sheath 200 can take on a variety of shapes to achieve the desired functionality.

[0037] 11 , according to some embodiments, a septum 210 is disposed at the distal end of the compressible sheath 200. According to some embodiments, the septum 210 comprises an axisymmetric body having a smooth, cylindrical outer wall. In other embodiments, the septum 210 comprises other shapes and textures. The septum 210 is formed of a rigid or semi-rigid material, and the septum 210 engages the needleless connector 100 when the needleless connector 100 is installed in the device 10. The septum 210 functions to transfer axial forces from the needleless connector 100 onto the compressible sheath 200 to push the compressible sheath 200 rearward from over the fixation cannula 32 and open fluid flow through the device 10. In such embodiments, the distal end of the compressible sheath 200 does not directly contact the interface 102 of the needleless connector 100, but instead, the septum 210 penetrates the interface 102 when the needleless connector 100 is installed in the device 10. The septum 210 is not required in all embodiments and may be omitted in embodiments where the compressible sheath 200 is sized and shaped to have sufficient strength and resilience to directly engage the interface 102, or where the needleless connector 100 is configured such that the fixation cannula 32 engages the interface 102 as described above. In other embodiments, the septum 210 may be integrally molded onto the compressible sheath 200 to form a one-piece structure. Additionally, in some embodiments, the septum 210 may be overmolded onto the compressible sheath 200 to form a separate component. In other embodiments, the septum 210 is a separate component that is pressure-fitted to the distal end of the compressible sheath 200. In some embodiments, the interface between the septum 210 and the compressible sheath 200 includes multiple corresponding radial flanges. Each flange provides an axial stop that prevents the septum 210 from sliding against the outer surface of the compressible sheath 200 when the septum 210 is pressed by the needleless connector 100.

[0038] 12-14, various embodiments of a device 10 including a visual indicator, an audible indicator, and / or a battery are shown. As described above, the device 10 may include a housing 30, a shell 40, and a separation component 50. The device 10 may be configured to provide one or more visual indications to a user that represent the status condition of the connector. For example, the device 10 may include one or more visual indicators 110 (e.g., lights indicating the status of the device 10). In some embodiments, the visual indicators 110 include LED lights that are visible to a user. The LED lights of the visual indicators 110 may be located on the surface of the housing 30, the shell 40, or the separation component 50 (as shown in FIG. 14, in particular). In some embodiments, the LED lights of the visual indicators 110 are located on the surface of the device 10 to provide a visual indication of the status of the device 10 (as shown in FIG. 12, in particular).

[0039] In some embodiments, the LED illumination of the visual indicator 110 may be configured to display a first color when the device is in a first state and a second color when the device is in a second state. Additionally, the LED illumination of the visual indicator 110 may have a blinking pattern to implement a status indicator of the apparatus 10. The LED illumination of the visual indicator 110 may flash a first color and pattern. The flashing frequency may increase over time immediately after separation. In some embodiments, the LED illumination of the visual indicator 110 may flash once every three seconds, then once every two seconds after five minutes, once every one second after fifteen minutes, and so on. After thirty minutes, the LED illumination of the visual indicator 110 may switch to a one-second light, two flashes / pulses, and then a one-second light again, repeating this pattern. Various other combinations and patterns may be implemented to indicate various status conditions to the user.

[0040] In some embodiments, the visual indicator 110 is mounted internally to the device 10 such that the visual indicator 110 is flush with the surface of the connector. In another embodiment, the connector material is translucent and the visual indicator 110 is embedded in the device 10 such that light emitted from the LED illumination of the visual indicator 110 is visible through the material of the device 10. Alternatively, and with particular reference to FIG. 13 , the visual indicator 110 may be located on an external structure attached to the exterior surface of the device 10. The LED illumination of the visual indicator 110 may be located on the outside of a ring, and the ring may be installed on the device 10 as a separate component.

[0041] As described above, device 10 may be configured to include one or more audible indicators. Audible indicator 112 may be configured to provide an audible signal to a user representing a status condition of device 10. In some embodiments, audible indicator 112 includes a speaker or an electronic sound-generating component. In some embodiments, audible indicator 112 is disposed on or near a surface of component 10. Audible indicator 112 may be configured to emit one or more sounds (e.g., an audible alarm) to indicate the status of device 10. In some embodiments, the audible alarm emits a first pattern of beeps after a detachment event, followed by an increasing rate of beeps over time. After a predetermined time has elapsed, audible indicator 112 may switch from an overly repetitive metronomic interval to another pattern (e.g., beep, silence, beep, beep, silence, beep, beep, beep, silence).

[0042] In some embodiments, device 10 includes both a visual indicator 110 and an audible indicator 112. In other embodiments, device 10 includes a visual indicator 110 but does not include an audible indicator 112. In other embodiments, device 10 includes an audible indicator 112 but does not include a visual indicator 110. Various other combinations of one or more visual indicators 110 and audible indicators 112 are contemplated within the scope of the present disclosure.

[0043] As described above with reference to FIGS. 12-14 , device 10 may be configured to include one or more batteries. For example, on-board electronic circuitry for visual indicator 110 and audible indicator 112 may be powered by battery 114. Battery 114 may be located on or near the surface of device 10 (as shown particularly in FIG. 12 ). Alternatively, battery 114 may be located on an external structure (e.g., a ring) disposed on the surface of device 10 (as shown particularly in FIG. 13 ). In some embodiments, battery 114 is arranged as a rotary switch, such as the hexagonal component shown in FIG. 13 , which allows a user to selectively attach or detach battery 114 from the electronic circuitry. For example, if the detached device 10 is to be discarded after a detachment event, the visual indicator 110 and / or audible indicator 112 can be disabled by rotating the hexagonal rotary switch to disconnect battery 114.

[0044] 14 , according to some embodiments, a visual indicator 110, an audible indicator 112, and / or a battery 114 may be located on the separation component 50. As described above with reference to FIG. 1 , the device 10 may include the first fitting 22. In some embodiments, the separation component 50 includes the first fitting 22, which is configured to attach to the needleless connector 100 of the patient's conduit set. The separation component 50 may also include a beveled window 54 and a beveled surface 56, which are configured to engage with corresponding locking arms 42 on the device. The separation component 50 may also include a protrusion 52, which extends away from the first fitting 22 to protect the pathway leading to the first fitting 22 and the seal 108 of the needleless connector 100 when the needleless connector 100 is attached. The separation component 50, in some embodiments, includes the visual indicator 110 described above, which may include LED lighting or other electronic components. The visual indicator 110, according to some embodiments, may be mounted flush with the exterior surface of the body of the isolation component 50. Alternatively, the visual indicator 110 may be located inside the isolation component 50, with light from the LED shining through the material of the body of the isolation component 50. As another alternative, the visual indicator 110 may be located on the exterior surface of the body of the isolation component 50.

[0045] In some embodiments, the separation component 50 includes the above-described audible indicator 112 configured to cause the device to emit a sound when the separation component 50 is separated from the housing 30 and shell 40. The audible indicator 112 may be mounted flush with a surface of the separation component 50, internal to the separation component 50, or external to the separation component 50, according to various embodiments.

[0046] In some embodiments, the isolation component 50 includes the battery 114 described above. When installed in the isolation component 50, the battery 114 is capable of powering the visual indicator 110 and / or the audible indicator 112. The battery 114 may be mounted flush with a surface of the isolation component 50, internal to the isolation component 50, or external to the isolation component 50, according to various embodiments.

[0047] 15 , various embodiments of a device 10 are shown, including a compressible sheath, an axially movable cannula, and / or a pull tab for operating a battery. As described above, the device 10 includes a housing 30 attached to a shell 40 and a separation component 50, which is attached to a needleless connector 100, thereby installing the device 10 to the needleless connector 100. The needleless connector 100 includes a seal 108. In some embodiments, the axially movable cannula 20 is disposed for axial translation within a fixed cannula 32, which is adjacent to a valve formed from a compressible sheath 206 and disposed on a hollow stem 208. When the needleless connector 100 is secured to the separation component 50, the axially movable cannula 20 compresses the compressible sheath 206, thereby opening the valve formed by the compressible sheath 206 and the hollow stem 208. At the same time (or nearly at the same time), the axially movable cannula 20 opens the seal 108 of the needleless connector 100. Upon application of the threshold tension necessary to actually separate the housing 30 and shell 40 from the separation component 50 and the needleless connector 100 attached to the separation component 50 (e.g., causing a "separation event"), the axially movable cannula 20 translates axially away from the housing 30, thereby closing the valve formed by the compressible sheath 206 and hollow stem 208. At the same time (or nearly at the same time), the axially movable cannula 20 separates from the needleless connector 100, thereby closing the seal 108.

[0048] In some embodiments, a pull tab 122 extending toward the housing 30 is secured to the separation component 50. Prior to a separation event, the pull tab 122 may reside within the battery housing 120, which contains the battery 114, so that the battery 114 is not in contact with the battery terminals. Thus, prior to a separation event, the battery 114 is maintained in an undischarged state, disconnected from electronic circuitry that provides power to components such as the visual and / or audible indicators (e.g., the visual and / or audible indicators 110 and 112). For example, as shown in FIG. 12 , the visual and / or audible indicators 110 and 112 may be housed within the housing 30 and / or shell 40. Upon a separation event, the pull tab 122 slides out of the battery housing 120, allowing the battery 114 to engage electronic circuitry onboard the device 10 and provide power to the visual and / or audible indicators 110 and 112. In this manner, pull tab 122 acts as a mechanical switch, preventing battery 114 from contacting its battery terminals and powering device 10 before a separation event, and allowing battery 114 to contact its battery terminals and power device 10 after a separation event. In this manner, battery 114 may remain in place without discharging before a separation event, thereby allowing device 10 to be stored for long periods of time without discharging battery 114 until needed to power visual indicator 110 and / or audible indicator 112.

[0049] 13 , the visual indicator 110 and / or the audible indicator 112 may alternatively be housed in the separation component 50. In such an embodiment, the pull tab 122 may be disposed on the housing 30 or shell 40 and protrude toward the separation component 50. The pull tab 122 disengages from the battery housing of the separation connector 50 immediately after a separation event. Thus, the shelf life of the device 10 can be two years or longer because the pull tab 122 prevents contact between the battery 114 and the corresponding terminals of the electronic circuitry until a separation event occurs.

[0050] In some embodiments, the present disclosure provides a detachment connector device having only one valve configured to attach to a needleless connector. By providing a device having only one valve, the apparatus can utilize the seal of the needleless connector to function as a patient-side valve in the event of a detachment.

[0051] In another embodiment, the present disclosure provides a method of securing an IV line utilizing the devices disclosed herein.

[0052] 16-21, there is shown a device 10 installed in a needleless connector 100, according to various embodiments of the present disclosure. As will be described in more detail below, the device 10 may be configured to accommodate various forces associated with the components of the device 10 and the needleless connector 100. Specifically, the device 10 may be configured to accommodate various forces such that the threshold tension required to cause a detachment event is within a desired range of detachment forces.

[0053] As described above, when the device 10 is installed in the needleless connector 100, components on the input side 12 (shown in FIG. 1 ) of the device 10 open the seal 108 of the needleless connector 100 by engaging the second fitting 103 of the needleless connector 100 with a corresponding feature on the first fitting 22 of the device 10. As shown, according to various exemplary embodiments described herein, the needleless connector 100 can include a body 104 that houses the seal 108 and defines an outlet 109 within the conduit junction 106. Thus, when the needleless connector 100 is installed in the device 10 as described herein, the seal 108 can be opened, allowing a fluid pathway from the inlet 19 to the outlet 109 to be established. As a first example, an axially movable cannula 20 can open the seal 108, as described above with reference to FIGS. 6-7 and 15 and as will be described in more detail later with reference to FIGS. 16-17 and 20-21 . As a second example, as discussed above with reference to Figures 9-11 and described in more detail below with reference to Figures 18-19, compressible sheath 200 and / or fixed cannula 32 may open seal 108. Thus, the component on input side 12 of device 10 that opens seal 108 may be a feature of housing 30 (e.g., fixed cannula 32) or a component of device 10 that engages housing 30 when device 10 is installed in needleless connector 100 (e.g., compressible sheath 200, fixed cannula 32, and / or axially movable cannula 20).

[0054] As described above, depending on the implementation of the present disclosure, various components of the input side 12 may advance into the needleless connector 100 and penetrate the interface 102, opening the seal 108. When the seal 108 is opened by a component of the device 10 (the "penetrating component") as described herein, the seal 108 may correspondingly exert a displacing force on the penetrating component (e.g., push the penetrating component). For example, the seal 108 may be biased to a closed configuration (e.g., a configuration in which fluid is not permitted to move through the seal 108 and the outlet 109). Thus, the seal 108 may be deformed (e.g., elastically) to reach an open configuration (e.g., a configuration in which fluid is permitted to move through the seal 108 and the outlet 109). Thus, while the seal 108 is being deformed to the open configuration by the penetrating component, the seal 108 may correspondingly generate a push-out force as a result of being biased back to a pre-deformed state (e.g., a closed configuration), thereby pushing the penetrating component in a direction away from the needleless connector 100 and toward the housing 30. As suggested above, the penetrating component may be a feature of the housing 30 or a component of the device 10 that engages with the housing 30 when the device 10 is installed in the needleless connector 100. Thus, while the device 10 is installed in the needleless connector 100, a push-out force may be applied from the needleless connector 100 to the housing 30, which acts to push the housing 30 in a direction away from the needleless connector 100.

[0055] As described above with reference to FIG. 8 , when a threshold tension associated with a detachment event is applied to the IV line, the needleless connector 100 and the separation component 50 can be separated together from the housing 30 and the shell 40. In contrast, a separation force different from the threshold tension may be required to separate only the separation component 50 from the housing 30 and the shell 40 (causing a “detachment event”). For example, the separation force associated with a detachment event can be adjusted by controlling the geometry and mechanical engagement between the separation component 50 and the shell 40. Of course, the threshold tension associated with a detachment event may alternatively be considered the tension associated with a detachment event plus the push-out force exerted by the needleless connector 100. Thus, in an exemplary scenario in which there is no push-out force from the needleless connector, the threshold tension associated with a detachment event would be equivalent to the separation force associated with a detachment event. In contrast, as described herein, when the device 10 is installed in the needleless connector 100, the needleless connector 100 actually provides the push-out force.

[0056] Thus, the threshold tension associated with a separation event may be, at least in part, the result of the push-out force and the separation force associated with the detachment event. For example, the push-out force may act to push the housing 30 away from the needleless connector 100 attached to the separation component 50. Thus, the push-out force may push the housing 30 in a manner that overlaps with the threshold tension applied to cause a separation event. In other words, the threshold tension required to cause a separation event may be the separation force minus the push-out force. For example, if the separation force is about 10 pounds and the push-out force is about 6 pounds, the threshold tension required to cause a separation event may be about 4 pounds.

[0057] In some circumstances, it may be advantageous to provide the device 10 such that the threshold tension falls within a desired range of separation forces associated with a detachment event. For example, the desired range of separation forces may be a clinically acceptable range of acceptable tensions associated with detaching one end of an IV line (e.g., the end of the IV line attached to the input side 12 of the device 10) from the other end of the IV line (e.g., the end of the IV line attached to the needleless connector 100 and the pump side 14 of the device 10). In that sense, the minimum (lower end) of the desired range of separation forces may be associated with ensuring that a smaller separation force does not result in detachment of one end of the IV line from the other end of the IV line. For example, it may be advantageous to ensure that common cases of patient movement cannot result in detachment of one end of the IV line from the other end of the IV line. Of course, the maximum (upper end) of the desired range of separation forces may be related to ensuring that a separation force approximately results in the detachment of one end of the IV line from the other end of the IV line. For example, advantageously, a substantial (perhaps unintentional) separation force, such as a sudden, unwanted movement by the patient during a procedure, may result in the detachment of one end of the IV line from the other end of the IV line, thereby preventing harm to the patient that would occur if the IV line were left connected.

[0058] In some embodiments, the desired range of separation force is from about 1 lb to about 6 lbs. Such a desired range may apply to human patients. In another embodiment, the desired range of separation force is from about 10 lb to about 15 lbs. Such a desired range may apply to veterinary patients, who may typically experience greater unintentional separation forces on IV lines. In yet another embodiment, the desired range of separation force is from about 1 lb to about 15 lbs (which thus corresponds, by way of non-limiting example, to both human and veterinary patients). Of course, different desired ranges of separation force may be defined for different patient scenarios, and the examples presented herein are not intended to limit the present disclosure to any particular range of separation force.

[0059] Thus, taking into account the desired range of separation forces described herein, the present disclosure provides methods (e.g., "methods of use") for using a separation connector device (such as device 10). The method of use may include a first step of providing a separation connector including housing 30 and separation component 50. As described above, housing 30 may include fixed cannula 32, and separation component 50 may include a separation force associated with separating housing 30 and shell 40 from separation component 50 (e.g., effecting a "detachment" event). The method of use may include a second step of providing needleless connector 100. Of course, needleless connector 100 may include seal 108 and a push-out force associated with seal 108. The method of use may include a third step of installing the separation connector on needleless connector 100, thereby opening a fluid flow path through seal 108 within fixed cannula 32. Thus, the three use steps presented herein may place a separation connector on the needleless connector 100 such that the needleless connector 100 applies an extrusion force to the housing 30, and the sum of the separation force and the extrusion force (e.g., the magnitude of the separation force minus the extrusion force) falls within a desired range of separation forces associated with separating the housing 30 from the needleless connector 100 (e.g., a separation event).

[0060] Accordingly, the present disclosure further provides a separation connector device (e.g., device 10) that attaches to a needleless connector (e.g., needleless connector 100). Device 10 may include a separation connector, which includes a housing 30 (including a fixed cannula 32) and a separation component 50 (removably secured to housing 30). Device 10 may further include only one valve disposed within fixed cannula 32. For example, as shown in FIG. 6 , device 10 may include a single valve 60. Additionally, the separation component may include a first fitting 22 configured to engage with a second fitting 103 disposed on the needleless connector 100 such that the needleless fitting 100 applies an extrusion force to the housing 30. Separation connector 50 may also include a separation force associated with separating the separation component from the shell. Finally, the sum of the separation force and the extrusion force may fall within a desired range of separation forces associated with separating the shell 40 from the needleless fitting 100.

[0061] As described in more detail below, the needleless connector 100 described herein may be implemented with any number of suitable needleless connectors known in the art. Each of the various needleless connectors with which the needleless connector 100 may be implemented may have a different push-out force associated with it. For example, the push-out force associated with a known needleless connector that implements the needleless connector 100 may be measured and recorded prior to implementing the needleless connector in a medical environment. Given the known push-out force of an implemented needleless connector and a desired range of separation forces, an appropriate implementation of the device 10 may be selected such that the resulting threshold tension required to cause a detachment event falls within the desired range of separation forces.

[0062] As mentioned above, the needleless connector 100 described herein may be implemented with any number of suitable needleless connectors known in the art, each having a different associated push force. As discussed above with reference to FIG. 4 , the needleless connector 100 may be implemented with a B. Braun Caresite, B. Braun Ultrasite, BD Q-Syte, BD MaxPlus, BD MaxZero, ICU Med MicroClave, ICU Neutron, Baxter One-Link, RyMed Invision Plus, or any other suitable needleless connector known in the art. Of course, in actual applications, various needleless connector implementations may provide a range of push forces depending on the particular needleless connector implementation manufactured and delivered for implementation into an IV line as described herein. Thus, as will be described in more detail below, device 10 may be supplied (or selected from several devices implementing device 10) such that the separation force associated with device 10 corresponds to the full range of push-out forces associated with the needleless connector being implemented.

[0063] Advantageously, the specific push-out force associated with a particular needleless connector may not need to be measured prior to implementing the needleless connector on an IV line. Instead, various parameters associated with the push-out force (e.g., minimum push-out force, maximum push-out force, average push-out force, etc.) provided by the particular needleless connector may be known or determined, and the device 10 may be prepared or selected based on such information. In some embodiments, the device 10 (and the separation force associated with the device 10) may be prepared or selected based on the average (or median) of known or determined push-out forces provided by the particular needleless connector (e.g., among a manufacturing sample of a particular variety of the particular needleless connector). In that sense, when a particular variety of the particular needleless connector is randomly provided, the resulting associated threshold tension required to cause a detachment event may be safely within a desired range of separation forces (e.g., toward the median or mean of the desired range of separation forces).

[0064] As a first example, B. Braun Caresite needleless connectors can provide a push-out force as high as about 3.4 pounds or as low as about 2.3 pounds, with an average push-out force of about 2.8 pounds, depending on the particular implementation of the needleless connector manufactured and implemented. Thus, to accommodate attachment to a B. Braun Caresite needleless connector where the desired range of separation force is about 1 pound to about 6 pounds, it may be advantageous to provide or select a device 10 that provides a separation force of about 6.3 pounds. Thus, an average B. Braun Caresite needleless connector, when installed in device 10, can result in a threshold tension of about 3.5 pounds (which is the 6.3 pound separation force minus the average push-out force of 2.8 pounds). If the B. Braun Keasyte needleless connector provides a high push-out force on the order of about 3.4 pounds, the resulting threshold tension can be about 2.9 pounds (which is the 6.3 pound separation force minus the 3.4 pound maximum push-out force). If the B. Braun Keasyte needleless connector provides a low push-out force on the order of about 2.3 pounds, the resulting threshold tension can be about 4 pounds (which is the 6.3 pound separation force minus the 2.3 pound minimum push-out force). Thus, the resulting threshold tension range associated with separating the housing 30 and shell 40 from the separation component 50 and the needleless connector 100 attached to the separation component 50 can be about 2.9 pounds to about 4 pounds (average 3.5 pounds), thereby placing the resulting threshold tension range required to cause a separation event within the desired range of about 1 pound to about 6 pounds of separation force.

[0065] As a second example, a B. Braun Ultrasite needleless connector can provide a push-out force as high as about 3.1 pounds and as low as about 1.9 pounds, with an average push-out force of about 2.6 pounds. Therefore, to accommodate attachment to a B. Braun Ultrasite needleless connector where the desired range of separation forces is about 1 pound to about 6 pounds, a device 10 can be provided or selected that provides a separation force of about 6.1 pounds. Thus, an average B. Braun Ultrasite needleless connector, when installed in device 10, can result in a threshold tension of about 3.5 pounds. If the B. Braun Ultrasite needleless connector provides a push-out force as high as about 3.1 pounds, the resulting threshold tension would be about 3 pounds. If the B. Braun Ultrasite needleless connector provides a low push-out force of about 1.9 pounds, the resulting threshold tension would be about 4.2 pounds. Thus, the resulting threshold tension range required to effect a separation event can be from about 3 pounds to about 4.2 pounds (average 3.5 pounds), thereby placing the resulting threshold tension range required to effect a separation event within the desired range of separation force from about 1 pound to about 6 pounds.

[0066] As a third example, a BD MaxPlus needleless connector can provide a push-out force as high as about 3.6 pounds, as low as about 2.7 pounds, and an average of about 3 pounds. Thus, to accommodate attachment to a BD MaxPlus needleless connector where the desired range of separation forces is about 1 pound to about 6 pounds, a device 10 can be provided or selected that provides a separation force of about 6.5 pounds. Thus, when installed in device 10, a BD MaxPlus needleless connector can provide a resulting threshold tension that is on average about 3.5 pounds, as high as about 3.8 pounds, or as low as about 2.9 pounds, thereby ensuring that the range of resulting threshold tensions required to cause a separation event falls within the desired range of separation forces of about 1 pound to about 6 pounds.

[0067] As a fourth example, a BD Q-Syte needleless connector can provide a push-out force as high as about 6.7 pounds, as low as about 3.4 pounds, and an average of about 5.1 pounds. Thus, to accommodate attachment to a BD Q-Syte needleless connector where the desired range of separation forces is about 1 pound to about 6 pounds, a device 10 can be provided or selected that provides a separation force of about 8.6 pounds. Thus, when installed in device 10, a BD Q-Syte needleless connector can provide a resulting threshold tension that is on average about 2.5 pounds, as low as about 1.9 pounds, or as high as about 3.4 pounds, thereby providing a range of resulting threshold tensions required to cause a separation event within the desired range of separation forces of about 1 pound to about 6 pounds.

[0068] As a fifth example, an ICU Med MicroClave needleless connector can provide a push-out force as high as about 3.1 pounds, as low as about 2.5 pounds, and an average of about 2.8 pounds. Thus, to accommodate attachment to an ICU Med MicroClave needleless connector where the desired range of separation forces is about 1 pound to about 6 pounds, a device 10 can be provided or selected that provides a separation force of about 6.3 pounds. Thus, when attached to device 10, an ICU Med MicroClave needleless connector can provide a resulting separation force of about 3.5 pounds, as low as about 3.2 pounds, or as high as about 3.8 pounds, thereby resulting in a range of threshold tensions required to cause a separation event within the desired range of separation forces of about 1 pound to about 6 pounds.

[0069] As a sixth example, the ICU Neutron needleless connector can provide a push-out force as high as about 3.1 pounds, as low as about 2.6 pounds, and an average of about 2.9 pounds. Thus, to accommodate attachment to the ICU Neutron needleless connector where the desired range of separation forces is about 1 pound to about 6 pounds, a device 10 can be provided or selected that provides a separation force of about 6.4 pounds. Thus, when installed in device 10, the ICU Neutron needleless connector can provide a resulting separation force that is on average about 3.5 pounds, as low as about 3.3 pounds, or as high as about 3.8 pounds, thereby ensuring that the range of threshold tension required to cause a detachment event falls within the desired range of separation forces of about 1 pound to about 6 pounds.

[0070] As a seventh example, a Baxter One-Link needleless connector can provide a push-out force as high as about 2 pounds, as low as about 1 pound, and an average of about 1.6 pounds. Thus, to accommodate attachment to a Baxter One-Link needleless connector where the desired range of separation forces is about 1 pound to about 6 pounds, a device 10 can be provided or selected that provides a separation force of about 5.1 pounds. Thus, when installed in device 10, a Baxter One-Link needleless connector can provide a resulting separation force that is on average about 3.5 pounds, as low as about 3.1 pounds, or as high as about 4.1 pounds, thereby resulting in a range of threshold tensions required to cause a separation event within the desired range of separation forces of about 1 pound to about 6 pounds.

[0071] As an eighth example, a RyMed Invision Plus needleless connector can provide a push-out force as high as about 2 pounds, as low as about 1 pound, and an average of about 1.5 pounds. Thus, to accommodate attachment to a RyMed Invision Plus needleless connector where the desired range of separation forces is about 1 pound to about 6 pounds, a device 10 can be provided or selected that provides a separation force of about 5 pounds. Thus, when attached to device 10, a RyMed Invision Plus needleless connector can provide a resulting separation force of about 3.5 pounds, as low as about 3 pounds, or as high as about 4 pounds, thereby resulting in a range of threshold tensions required to cause a separation event within the desired range of separation forces of about 1 pound to about 6 pounds.

[0072] 16-17, a device 10 is shown installed in a needleless connector 100 according to some embodiments of the present disclosure. Figures 16-17 illustrate this installation with an embodiment of the device 10 including an axially movable cannula 20 housed in a fixed cannula 32 of a housing 30, as described above with reference to Figures 6-7. In the exemplary embodiment shown, the needleless connector 100 includes a seal 108, which operates as an accordion seal or compressible sheath (e.g., an accordion-style compressible sheath) with a split septum-style tip biased to a closed configuration. The seal 108 can be deformed by the axially movable cannula 20 of the device 10 to reach an open configuration (in other words, the "penetrating component" described above is the axially movable cannula 20). In such an embodiment, the seal 108 may be formed from a flexible material (e.g., plastic, silicone, polymer, or elastomer).

[0073] According to some embodiments, Figure 16 illustrates the device 10 and needleless connector 100 before the device 10 is installed in the needleless connector 100, while Figure 17 illustrates the device 10 and needleless connector 100 when the device 10 is installed in the needleless connector 100, thereby deforming the seal 108 to reach an open configuration. As shown in particular in Figure 17, the second fitting 103 of the needleless connector 100 may engage a corresponding feature on the first fitting 22, thereby causing the axially movable cannula 20 to penetrate the interface 102 of the needleless connector 100. Once the axially movable cannula 20 penetrates the interface 102, the axially movable cannula 20 can then engage and deform the seal 108, pushing it toward the outlet 109, thereby opening the split septum tip of the seal 108 and opening a fluid pathway from the interface 102 to the outlet 109. At the same time (or nearly at the same time), the axially movable cannula 20 can be advanced toward the inlet 19, thereby advancing the stem 28 into the valve chamber 34, thereby activating and opening the valve 60 in the valve chamber 34 (as described above with reference to FIGS. 6-7 ), thereby opening a fluid pathway from the inlet 19 to the axially movable cannula 20. In this way, a fluid pathway can be opened from the inlet 19 of the device 10 to the outlet 109 of the needleless connector 100.

[0074] As suggested above, when the seal 108 is deformed by the axially movable cannula 20 to reach the open configuration, the seal 108, as a result of being biased back to the closed configuration, can correspondingly exert a pushing force on the axially movable cannula 20, thereby pushing the axially movable cannula 20 in a direction away from the needleless connector 100 and toward the housing 30. In some embodiments, the pushing force is transmitted by the axially movable cannula 20 to the housing 30, such that, collectively, the seal 108 exerts a pushing force on the housing 30. As one example, when the stem 28 activates and opens the valve 60, the valve 60 can be biased toward the inlet 19 against the valve chamber 34 of the housing 30. As another example, as the axially movable cannula 20 advances toward the inlet 19, the outer surface of the axially movable cannula 20 can exert a frictional force against the inner surface of the fixed cannula 32 of the housing 30 in the direction of the inlet 19. As yet another example, stem 28 may push or exert a frictional force against input seal 36 of housing 30 toward inlet 19 such that stem 28 activates valve 60 open. In this manner, seal 108 may exert all of the extrusion force on housing 30. Thus, in some embodiments, as described above, the threshold tension required to cause a separation event may be the separation force (which may be adjustable by controlling the geometry and mechanical engagement between separation component 50 and shell 40 of device 10, as described above with reference to FIG. 8 ) minus the extrusion force.

[0075] In contrast, in another embodiment, the threshold tension required to cause a separation event may be the separation force minus the push-out force plus the biasing force applied by device 10. For example, when stem 28 activates valve 60 open, valve 60 may exert a biasing force on stem 28, thereby pushing axially movable cannula 20 toward needleless connector 100. Thus, if valve 60 exerts such a biasing force on stem 28, the threshold tension required to cause a separation event may be the separation force minus the push-out force plus the biasing force applied by valve 60 of device 10.

[0076] As discussed above, given a known push-out force of the needleless connector 100, such as that shown in Figures 16-17, and a desired range of separation forces, an appropriate implementation of the device 10 may be prepared such that the resulting threshold tension required to cause a separation event falls within the desired range of separation forces.

[0077] 18-19, a device 10 is shown installed in a needleless connector 100, according to some embodiments of the present disclosure. Figures 18-19 illustrate this installation with an embodiment of the device 10 including a compressible sheath 200 placed over the fixed cannula 32, as described above with reference to Figures 9-11. In the exemplary embodiment shown, the needleless connector 100 includes a seal 108, which operates as a push seal biased to a closed configuration. The seal 108 is compressibly deformable to an open configuration, biased to a closed position, and opened by the compressible sheath 200 of the device 10. In such embodiments, the seal 108 may be formed from a flexible material (e.g., plastic, silicone, polymer, or elastomer).

[0078] According to some embodiments, Figure 18 shows the device 10 and needleless connector 100 before the device 10 is installed in the needleless connector 100, while Figure 19 shows the device 10 and needleless connector 100 when the device 10 is installed in the needleless connector 100, thereby opening the seal 108 of the needleless connector 100. As particularly shown in Figure 19, the second fitting 103 of the needleless connector 100 engages with a corresponding feature on the first fitting 22, thereby engaging the compressible sheath 200 with the interface 102.

[0079] 9-11 and as shown in FIG. 19 , compressible sheath 200 may not be sized and shaped to have sufficient strength and resilience to penetrate interface 102. In such embodiments, when compressible sheath 200 engages interface 102, interface 102 may push compressible sheath 200 rearward over fixed cannula 32, thereby opening seal 202 and allowing fluid to travel from inlet 19 through fixed cannula 32. Simultaneously (or nearly simultaneously), fixed cannula 32 may penetrate interface 102 and engage and deform seal 108, thereby allowing fluid to travel from interface 102 to outlet 109 (in other words, the “penetrating component” discussed above is fixed cannula 32). In this manner, a fluid pathway from inlet 19 to outlet 109 may be opened.

[0080] 9-11 , the compressible sheath 200 may be sized and shaped to have sufficient strength and resilience to directly engage the interface 102. In such an embodiment, when the needleless connector 100 is installed in the device 10, the distal end of the compressible sheath 200 may engage the interface 102, thereby opening the seal 202 and allowing fluid to pass from the inlet 19 through the compressible sheath 200. Simultaneously (or nearly simultaneously), the distal end of the compressible sheath 200 may penetrate the interface 102 and engage and deform the seal 108, thereby allowing fluid to pass from the interface 102 to the outlet 109 (in other words, the "penetrating component" discussed above is the compressible sheath 200). In this manner, a fluid pathway may be opened from the inlet 19 to the outlet 109 of the needleless connector 100.

[0081] As suggested above, when the seal 108 is deformed by the compressible sheath 200 and / or the fixed cannula 32 to reach and open the open configuration, the seal 108 may exert a corresponding pushing force on the compressible sheath 200 and / or the fixed cannula 32 as a result of being biased back to the closed configuration.

[0082] In some embodiments (as shown in FIG. 19 ), compressible sheath 200 is pushed rearwardly over fixation cannula 32 so that it does not penetrate interface 102, the pushing force may be applied (e.g., partially) to both compressible sheath 200 (which transmits the pushing force to housing 30) and fixation cannula 32 (and, optionally, septum 210) of housing 30. As a first example, as compressible sheath 200 is pushed rearwardly over fixation cannula 32, compressible sheath 200 may become compressed, thereby transmitting a first portion of the pushing force to housing 30 at or near the base of fixation cannula 32 (e.g., where compressible sheath 200 forms sheath flange 206). As a second example, because seal 108 is open due to mechanical engagement between fixed cannula 32 of housing 30 and seal 108, seal 108 can apply a second portion of the push-out force directly to fixed cannula 32. In this manner, seal 108 can apply the entire push-out force to housing 30.

[0083] In another embodiment in which compressible sheath 200 penetrates interface 102, the push-out force may be applied to compressible sheath 200, which transmits the push-out force to housing 30. For example, compressible sheath 200 may be in a compressed state, thereby transmitting the push-out force to housing 30 at or near the base of fixation cannula 32 (e.g., where compressible sheath 200 forms sheath flange 206). In this manner, seal 108 may apply the entire push-out force to housing 30.

[0084] Thus, in some embodiments, as described above, the threshold tension required to cause a separation event may be the separation force (which can be adjusted by controlling the geometry and mechanical engagement between the separation component 50 and the shell 40 of the device 10, as described above with reference to FIG. 8) minus the push-out force.

[0085] In contrast, in another embodiment, the threshold tension required to cause a separation event may be the separation force minus the push-out force plus the biasing force applied by device 10. For example, when compressible sheath 200 is pushed rearward over fixation cannula 32, compressible sheath 200 may be in a compressed state, thereby applying a biasing force to interface 102. In this manner, when compressible sheath 200 applies such a biasing force to interface 102, the threshold tension required to cause a separation event may be the separation force minus the push-out force plus the biasing force applied by compressible sheath 200 of device 10.

[0086] As discussed above, given a known push-out force of the needleless connector 100, such as that shown in Figures 18-19, and a desired range of separation forces, an appropriate implementation of the device 10 may be prepared such that the resulting threshold tension required to cause a separation event falls within the desired range of separation forces.

[0087] 20-21 , a device 10 is shown installed in a needleless connector 100, according to some embodiments of the present disclosure. FIGS. 20-21 illustrate this installation with an embodiment of the device 10 including an axially movable cannula 20 arranged to translate axially within a fixed cannula 32 adjacent to a valve formed by a compressible sheath 206 over a hollow stem 208, as described above with reference to FIG. 15 . In the exemplary embodiment shown, the seal 108 of the needleless connector 100 has a V-shaped joint. As shown in FIG. 20 , the V-shaped joint may be biased in an open position, while material surrounding the seal 108 presses the V-shaped joint into a closed position, biasing the V-shaped joint to hold the V-shaped joint close to the interface 102. The seal 108 can be deformed to reach the open configuration by the axially movable cannula 20 of the device 10 (in other words, the "penetrating component" described above is the axially movable cannula 20). In such an embodiment, the V-shaped joint in the seal 108 may be formed from a rigid material such as nylon or plastic, while the remainder of the seal 108 may be formed from a flexible material such as plastic, silicone, a polymer, or an elastomer.

[0088] According to some embodiments, Figure 20 shows the device 10 and needleless connector 100 before the device 10 is installed in the needleless connector 100, while Figure 21 shows the device 10 and needleless connector 100 when the device 10 is installed in the needleless connector 100, thereby deforming the seal 108 to reach an open configuration. As particularly shown in Figure 21, the second fitting 103 of the needleless connector 100 may engage a corresponding feature on the first fitting 22, thereby causing the axially movable cannula 20 to penetrate the interface 102 of the needleless connector 100. As the axially movable cannula 20 penetrates the interface 102, it can engage a V-shaped joint in the seal 108, deforming the material surrounding the seal 108 and pushing the V-shaped joint away from the interface 102 and toward the outlet 109, thereby allowing the V-shaped joint to open and move the seal 108 to an open configuration. Thus, a fluid pathway can be established from the interface 102 to the outlet 109. Simultaneously (or nearly simultaneously), the axially movable cannula 20 compresses the compressible sheath 206 (as described above with reference to FIG. 15 ), thereby opening the valve formed by the compressible sheath 206 and hollow stem 208 and establishing a fluid pathway from the inlet 19 to the axially movable cannula 20. In this manner, a fluid pathway can be established from the inlet 19 of the device 10 to the outlet 109 of the needleless connector 100.

[0089] As suggested above, when the seal 108 is deformed by the axially movable cannula 20 to reach the open configuration, the material surrounding the seal 108 is biased to move the V-shaped joint away from the outlet 109, thereby holding the V-shaped joint near the interface 102. Thus, as a result of the seal 108 being biased back to the closed configuration, it can exert a corresponding pushing force on the axially movable cannula 20, pushing the axially movable cannula 20 away from the needleless connector 100 and toward the housing 30. In some embodiments, the pushing force is transmitted by the axially movable cannula 20 to the housing 30, such that, collectively, the seal 108 exerts a pushing force on the housing 30. As an example, when the axially movable cannula 20 compresses the compressible sheath 206, the compressible sheath 206 can push the housing 30 toward the inlet 19. As another example, as axially movable cannula 20 advances toward inlet 19, the outer surface of axially movable cannula 20 can exert a frictional force on the inner surface of fixed cannula 32 of housing 30 in the direction of inlet 19. In this manner, seal 108 can exert all of the push-out force on housing 30. Thus, in some embodiments, as described above, the threshold tension required to cause a separation event can be the magnitude of the separation force (which can be adjusted by controlling the geometry and mechanical engagement between separation component 50 and shell 40 of device 10, as described above with reference to FIG. 8 ) minus the push-out force.

[0090] In contrast, in some embodiments, the threshold tension required to cause a separation event may be the separation force minus the push-out force plus the biasing force applied by the device 10. For example, when the axially moveable cannula 20 compresses the compressible sheath 206, the compressible sheath 206 can apply a biasing force against the axially moveable cannula 20, thereby pushing the axially moveable cannula 20 toward the needleless connector 100. Thus, when the compressible sheath 206 applies such a biasing force against the axially moveable cannula 20, the threshold tension required to cause a separation event may be the separation force minus the push-out force plus the biasing force applied by the compressible sheath 206 of the device 10.

[0091] Referring now to FIG. 22 , the device 10 is shown detached from the needleless connector 100, according to some embodiments. In the illustrated exemplary embodiment, the needleless connector 100 includes a seal 108, which operates as an accordion seal or compressible sheath (e.g., an accordion-style compressible sheath) with a split septum tip, as described above with reference to FIGS. 16-17 . When a threshold tension associated with a detachment event is applied to the IV line, the needleless connector 100 and separation component 50 can be separated together from the shell 40 and housing 30. Immediately following the detachment event, the axially movable cannula 20 can automatically extend away from the valve 60 in the valve chamber 34, either by the force of the valve 60 pushing against the axially movable cannula 20 or by a coil spring or other biasing member in the fixed cannula 32. After detachment, the separation component 50 is completely separated from the shell 40.

[0092] 23, a kit 300 of separation connector devices is shown, according to some embodiments. As discussed above, given a known push-out force (or statistical parameters associated therewith) associated with a needleless connector, one of a plurality of separation connector devices provided in kit 300 may be selected such that, when the selected separation connector device is attached to the needleless connector, the resulting threshold tension sufficient to cause a separation event falls within a desired range of separation forces.

[0093] In some embodiments, kit 300 includes two or more separation connector devices described herein, each having a different associated separation force. For example, kit 300 may include device 10 and separation connector device (device) 310, which may include housing 330, shell 340, fitting 322, separation component 350, and axially movable cannula 320, corresponding to device 10.

[0094] As described above, the separation force associated with embodiments of device 10 can be adjusted by controlling the geometry and mechanical engagement between separation component 50 and shell 40. Similarly, the separation force associated with device 310 can be adjusted by controlling the geometry and mechanical engagement between separation component 350 and shell 340. In this manner, multiple implementations of device 10 can be provided by including in kit 300 a variety of separation forces known to a user of kit 300. While the illustrated kit 300 includes two separation connector devices, it should be understood that kit 300 may include any number of separation connector devices to provide a wide range of associated separation forces that can be applied to various needleless fittings to achieve threshold tensions that meet various desired ranges of separation forces associated with a separation event.

[0095] Thus, given multiple implementations of apparatus 10 that can be provided with different separation forces associated with apparatus 10, the present disclosure provides a method (e.g., “selection method”) for selecting a separation connector device (e.g., apparatus 10 and apparatus 310) for attachment to a needleless connector (e.g., needleless connector 100) of an IV line. The selection method may include a first step of providing a needleless connector 100 for attachment to the separation connector. For example, the needleless connector 100 may be obtained at the start of the selection method or may already be installed on the IV line. Of course, the needleless connector 100 may have a push force associated with it. The selection method may include a second step of identifying the push force exerted by the needleless connector 100. For example, the push force may be identified by direct measurement, or the push force (or a statistical parameter associated with the push force) may simply be known (e.g., recorded in association with a particular embodiment of the needleless connector 100). In this sense, the pushing force may be measured or known as a value such as, by way of example, about 2 pounds.

[0096] The selection method may include a third step of identifying a desired range of separation forces associated with separating a first portion of the IV line (e.g., input side 12) from a second portion of the IV line (e.g., output side 14). For example, the desired range of separation forces may be from about 1 pound to about 6 pounds. The selection method may include a fourth step of selecting a separation connector device (e.g., device 10, device 310, etc.) such that the sum of the separation force and the push-out force (e.g., separation force minus push-out force) falls within the desired range of separation forces. As a non-limiting example, device 10 may include a separation force of about 5 pounds, and device 310 may include a separation force of about 10 pounds. Thus, in this non-limiting example, installation of device 10 would result in a threshold tension sufficient for a separation event of about 3 pounds, and installation of device 310 would result in a corresponding threshold tension of about 8 pounds. Device 10 may be selected accordingly. This is because the resulting threshold tension of approximately 3 pounds sufficient for a separation event falls within the desired range of separation forces, while the corresponding threshold tension of approximately 8 pounds does not.

[0097] Accordingly, the present disclosure further provides a kit (e.g., kit 300) for attaching a separation connector device to a needleless connector (e.g., needleless connector 100) that provides a push-out force. Kit 300 may include a first separation connector (e.g., device 10) having a first housing (e.g., housing 30) and a first separation component (separation component 50). Thus, device 10 provides a first separation force associated with separating the first housing from the first separation component. Kit 300 may also include a second separation connector (e.g., device 310) having a second housing (e.g., housing 330) and a second separation component (separation component 350). Thus, device 310 provides a second separation force associated with separating the second housing from the second separation component. The second separation force may differ from the first separation force due to the aforementioned adjustments that may differentiate the separation forces among various separation connector devices. Each of the devices 10, 310 is configured to be attached to the needleless connector 310, and at least one of the first and second separation forces, when combined with the push-out force exerted by the needleless fitting 100, results in a sum within a desired range of separation forces associated with separating the first housing or the second housing, respectively, from the needleless fitting 100.

[0098] While particular embodiments of the novel and useful devices and methods of this invention have been described above, such references are not to be construed as limitations on the scope of the invention except as set forth in the claims.

Claims

1. 1. A method for selecting a breakaway connector device for attachment to a needleless connector of an intravenous (IV) line, comprising: providing a needleless connector for attachment to a separation connector, the needleless connector including an ejection force associated with the needleless connector; identifying the push-out force exerted by the needleless connector; identifying a desired range of separation forces associated with separating a first portion of the IV line from a second portion of the IV line; selecting a separation connector apparatus including a housing and a separation component configured to detach from the housing when a separation force is applied to the device, such that the sum of the separation force and the push-out force is within the desired range of separation forces; A method comprising:

2. The method of claim 1 , wherein the desired range of separation force is from about 1 lb to about 15 lbs.

3. The method of claim 1 , wherein the desired range of separation force is from about 1 lb to about 6 lbs.

4. 1. A method of using a breakaway connector device, comprising: providing a separation connector including a housing and a separation component removably secured to the housing, the housing having a locking cannula, the separation connector including a separation force associated with removing the housing from the separation component; providing a needleless connector including a seal; placing the separation connector on the needleless connector so that a fluid path is open into the fixed cannula and through the seal of the needleless connector; Including, when the separation connector is placed on the connector, the needleless connector applies a push-out force to the housing, the sum of the separation force and the push-out force being within a desired range of separation forces associated with separating the housing from the needleless connector. method.

5. The separation connector further includes an axially movable cannula disposed within the fixed cannula; When the separation connector is installed on the needleless connector, the axially movable cannula opens the seal of the needleless connector. The method of claim 4.

6. The separation connector further includes a valve disposed within the fixation cannula; When the separation connector is installed in the needleless connector, the axially movable cannula opens the valve. The method of claim 5.

7. The method of claim 6 , wherein the valve comprises a compressible sheath.

8. The method of claim 6 , wherein the valve comprises a duckbill valve.

9. the housing further includes a valve disposed in the fixation cannula, the valve having a compressible sheath; When the separation connector is placed on the needleless connector, the needleless connector opens the valve. The method of claim 4.

10. The method of claim 10 , wherein the compressible sheath opens the seal when the separation connector is placed on the needleless connector.

11. The method of claim 10, wherein the fixed cannula opens the seal when the breakaway connector is installed on the needleless connector.

12. A breakaway connector device attached to a needleless connector, comprising: a separation connector including a housing having a fixed cannula and a separation component removably secured to the housing; a single valve disposed within the fixed cannula; Including, the separation component includes a socket configured to engage the needleless connector, whereby the needleless connector applies an ejection force to the housing; the separation connector includes a separation force associated with removing the separation component from the shell; the sum of the separation force and the push-out force is within a desired range of separation forces associated with separating the shell from the needleless connector. Device.

13. The device of claim 12 , wherein the valve comprises a compressible sheath.

14. The device of claim 12 , wherein the valve comprises a duckbill valve.

15. The device of claim 12 further comprising an axially movable cannula disposed within the fixed cannula.

16. The device of claim 15 , wherein the valve comprises a compressible sheath.

17. The separation connector further includes a shell disposed in the housing; the shell includes a fixed arm; 13. The apparatus of claim 12.

18. the separation component includes a beveled surface and a beveled window; When the separation component is secured to the housing, the securing arm extends into the beveled window and engages the beveled surface.

18. The apparatus of claim 17.

19. 20. The apparatus of claim 18, wherein the locking arm is configured to disengage from the ramp when the separation force is applied to the separation connector.

20. 1. A kit for attaching a breakaway connector device to a needleless connector that provides an ejection force, comprising: a first separation connector having a first housing and a first separation component, the first separation connector providing a first separation force associated with separating the first housing from the first separation component; a second separation connector having a second housing and a second separation component, the second separation connector providing a second separation force associated with separating the second housing from the second separation component, the second separation force being different from the first separation force; Including, each of the first detachable connector and the second detachable connector is configured to be attached to the needleless connector; at least one of the first separation force and the second separation force, when combined with the push-out force exerted by the needleless fitting, results in a total separation force within a desired range associated with separating the first housing or the second housing, respectively, from the needleless fitting; kit.

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