Patent Publication Number: US-2023149689-A1

Title: Breakaway connector

Description:
A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the reproduction of the patent document or the patent disclosure, as it appears in the U.S. Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. 
    
    
     CROSS REFERENCES TO RELATED APPLICATION 
     This application is a continuation-in-part of U.S. Pat. Application 17/884,391 filed Aug. 9, 2022 entitled BREAKAWAY CONNECTOR, which is a non-provisional of U.S. Pat. Application No. 63/231,020 filed Aug. 9, 2021 entitled BREAKAWAY CONNECTOR, which are hereby incorporated by reference in their entirety. 
    
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH DEVELOPMENT 
     Not Applicable. 
    
    
     BACKGROUND 
     The present invention relates to devices and methods for fluid line connectors for medical and veterinary applications. More particularly, the present invention relates to breakaway connectors for attachment to needle-free connectors on intravenous fluid lines. 
     Conventional devices and methods for breakaway fluid line connectors generally include two housings joined together. A fluid pathway through the connector is broken when the two housings separate, and a valve in each housing is operable to stop the flow of fluid on each side when a separation event occurs. Conventional devices and methods utilizing such a configuration are used for a variety of applications, including intravenous (IV) medical lines including a soft, flexible tube placed inside a vein, usually in the hand or arm. When a sufficient amount of tension is applied to the line, the connector will separate, and the valves on each component of the connector will block fluid flow to prevent leakage. 
     In many medical applications, and particularly in peripheral IV lines, healthcare providers are increasingly implementing needle-free connectors to protect clinicians and patients. Needle-free connectors provide an access port to an IV line that does not require a needle insertion for transfer of fluids. Instead, needle-free connectors include a patient-side luer fitting with a seal that may be opened or pierced by a corresponding injection-side luer fitting or syringe. The seal receives the injection-side fitting in a sealed engagement, thereby establishing a fluid flow path between the injection-side component and the needle-free connector on the patient-side tubing apparatus. The seal may include a septum-style seal, an accordion seal, a compressible sheath, a push seal, or any other suitable seal known in the art for a needle-free engagement. 
     Needle-free connectors allow for quick connection and disconnection without the need for needles to transfer fluids. When the injection-side fitting is removed from the needle-free connector, the seal on the needle-free connector closes automatically, thereby preventing leakage of any fluid from the patient-side tubing assembly. As such, the needle-free connector on the patient-side includes an available seal which operates as a check valve to allow fluid flow into the patient-side tubing when opened, but preventing outflow when closed. These types of needle-free connectors have been rigorously designed to protect from contamination and can be easily cleaned to sterilize the external interfacing element and ensure microbes cannot ingress into the fluid path. 
     As mentioned above, when a sufficient amount of tension is applied to the line, the connector will separate. In many medical applications, it may be desirable (or clinically required) that the connector separates within a clinically accepted range of tension. For example, in order to protect clinicians and patients, it may be paramount that the connector does not separate under too little tension (e.g., a typical or otherwise expected bodily movement, adjustment of the line, etc.). Similarly, it may be paramount that the connector does in fact separate under a reasonable amount of tension (e.g., a powerful movement that, should the connector remain intact, causes injury or other issues). 
     Conventional breakaway fluid line connectors with two valves (one on each component side of the breakaway mechanism) are generally not optimized for use with needle-free connectors because such configurations effectively include three valves when installed on (e.g., attached to, engaged with, etc.) a needle-free connector. The three valves include the injection-side valve on the connector, the outflow side valve on the connector and the seal on the needle-free connector. This type of configuration unnecessarily includes an intermediate valve and leads to a bulky and oversized assembly at an infusion site. As such, it is desirable to provide improvements to breakaway connector devices to make the engagement more efficient in size, scale and operation, while separating under a tensile force that is within a desirable range for patient and clinician safety. 
     What is needed are improvements in devices and methods for breakaway connectors for use with fluid applications, and particularly for use with needle-free connectors in IV lines in medical and veterinary applications. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG.  1    illustrates a perspective view of an embodiment of a breakaway connector apparatus in accordance with the present disclosure. 
         FIG.  2    illustrates a perspective cross-sectional view of the embodiment of a breakaway connector apparatus of  FIG.  1    with the axially-moveable cannula in a disengaged position. 
         FIG.  3    illustrates a perspective cross-sectional view of the embodiment of a breakaway connector apparatus of  FIG.  1    with the axially-moveable cannula in an engaged position. 
         FIG.  4    illustrates a perspective exploded view of an embodiment of a breakaway connector apparatus in accordance with the present disclosure positioned for installation on a needle-free connector. 
         FIG.  5    illustrates a perspective view of an embodiment of a breakaway connector apparatus in accordance with the present disclosure installed on a needle-free connector. 
         FIG.  6    illustrates a cross-sectional view of an embodiment of a breakaway connector apparatus positioned for installation on a needle-free connector. 
         FIG.  7    illustrates a cross-sectional perspective view of an embodiment of a breakaway connector apparatus installed on a needle-free connector. 
         FIG.  8    illustrates a cross-sectional perspective view of an embodiment of a breakaway connector apparatus with a breakaway component and needle-free connector detached from the apparatus. 
         FIG.  9    illustrates a perspective view of an alternative embodiment of a breakaway connector apparatus in accordance with the present disclosure. 
         FIG.  10    illustrates a cross-sectional perspective view of the embodiment of a breakaway connector apparatus of  FIG.  9   . 
         FIG.  11    illustrates a cross-sectional perspective of an alternative embodiment of a breakaway connector apparatus in accordance with the present disclosure. 
         FIG.  12    illustrates a perspective view of an alternative embodiment of a breakaway connector apparatus in accordance with the present disclosure. 
         FIG.  13    illustrates a perspective view of an alternative embodiment of a breakaway connector apparatus in accordance with the present disclosure. 
         FIG.  14    illustrates a perspective view of an embodiment of a breakaway component including a battery, visual indicator and audio indicator. 
         FIG.  15    illustrates a cross-sectional view of an embodiment of a breakaway connector apparatus including an axially-moveable cannula, a compressible sheath and a battery housing including a battery, and including a pull tab to activate the battery-powered electronic circuit. 
         FIG.  16    illustrates a cross-sectional view of an embodiment of a breakaway connector apparatus positioned for installation on a needle-free connector. 
         FIG.  17    illustrates a cross-sectional perspective view of an embodiment of a breakaway connector apparatus installed on a needle-free connector. 
         FIG.  18    illustrates a cross-sectional view of an embodiment of a breakaway connector apparatus positioned for installation on a needle-free connector. 
         FIG.  19    illustrates a cross-sectional perspective view of an embodiment of a breakaway connector apparatus installed on a needle-free connector. 
         FIG.  20    illustrates a cross-sectional view of an embodiment of a breakaway connector apparatus positioned for installation on a needle-free connector. 
         FIG.  21    illustrates a cross-sectional perspective view of an embodiment of a breakaway connector apparatus installed on a needle-free connector. 
         FIG.  22    illustrates a cross-sectional perspective view of an embodiment of a breakaway connector apparatus with a breakaway component and needle-free connector detached from the apparatus. 
         FIG.  23    illustrates a perspective view of an embodiment of a kit for attaching a breakaway connector device to a needle-free connector. 
     
    
    
     BRIEF SUMMARY 
     The present disclosure relates to breakaway connector apparatuses and methods for fluid lines. In some embodiments, the present disclosure provides a method of selecting a breakaway connector apparatus for attachment to a needle-free connector on an intravenous (IV) line attached to a patient. The method includes identifying a push-out force that is associated with the needle-free connector, as well as a desired range of 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 breakaway connector apparatus that includes a housing and a breakaway component that is configured to detach from the housing when a breakaway force is applied to the device, such that a sum of the breakaway force and the push-out force is within the desired range of separation force. 
     For example, when a breakaway force is applied to the breakaway connector itself, the breakaway component detaches from the housing and a shell of the apparatus. When the apparatus is installed on the needle-free connector, however, the needle-free fitting imparts a push-out force on the apparatus, thereby pushing the housing away from the needle-free fitting and the breakaway component attached thereto. Overall, when a threshold tensile force is applied to the breakaway connector, the needle-free connector and the breakaway component on the device separate together as one unit from the housing and the shell of the apparatus. Upon such an event, a valve in the device blocks incoming fluid flow, and the seal on the needle-free connector blocks outflow from the patient-side tubing assembly. 
     By taking advantage of identifying the push-out force of the needle-free connector, a breakaway connector apparatus can be selected that includes a proper breakaway force, such that the breakaway force and the push-out force, in sum, result in a threshold tensile force required for separation that is within the desired range of separation force. 
     In further embodiments, the present disclosure provides a method of using a breakaway connector apparatus. The method includes providing a breakaway connector including a housing and a breakaway component detachably secured to the housing. The breakaway connector includes a breakaway force associated with detaching the housing from the breakaway component. The method further includes providing a needle-free connector including a seal. The method further includes installing the breakaway connector on the needle-free connector. When the breakaway connector is installed on the needle-free connector, the needle-free connector imparts a push-out force on the housing, and a sum of the breakaway force and the push-out force is within a desired range of separation force associated with separating the housing from the needle-free connector. 
     In further embodiments, the present disclosure provides a breakaway connector apparatus including a breakaway connector. The breakaway connector has a housing, a fixed cannula, and a breakaway component detachably secured to the housing. The apparatus further includes only one valve disposed within the fixed cannula. The breakaway component includes a socket configured for engagement with the needle-free connector, such that the needle-free connector imparts a push-out force on the housing. The breakaway connector includes a breakaway force associated with detaching the breakaway component from the shell. A sum of the breakaway force and the push-out force is within a desired range of separation force associated with separating the shell from the needle-free connector. 
     Numerous other features and advantages of the present disclosure are set forth in the following description and accompanying figures. 
     DETAILED DESCRIPTION 
     While the making and using of various embodiments of the present invention are discussed in detail below, it should be appreciated that the present invention provides many applicable inventive concepts that are embodied in a wide variety of specific contexts. The specific embodiments discussed herein are merely illustrative of specific ways to make and use the invention and do not delimit the scope of the invention. Those of ordinary skill in the art will recognize numerous equivalents to the specific apparatus and methods described herein. Such equivalents are considered to be within the scope of this invention and are covered by the claims. 
     In the drawings, not all reference numbers are included in each drawing, for the sake of clarity. In addition, positional terms such as “upper,” “lower,” “side,” “top,” “bottom,” etc. refer to the apparatus when in the orientation shown in the drawing. A person of skill in the art will recognize that the apparatus can assume different orientations when in use. 
     Referring now to  FIG.  1   , the present disclosure provides a breakaway connector apparatus  10  for attachment to a fluid line. The apparatus  10  includes an input side  12  and an output side  14 . The input side  12  may be referred to as a pump side when the device is coupled to an infusion pump. The output side  14  may be referred to as a patient side when the device is coupled to a patient’s IV line. An input fitting  16  includes a male or female luer fitting in some embodiments. 
     A socket  18  disposed in the apparatus  10  at the output side  14  provides a cavity or recess shaped to accommodate insertion of a needle-free connector on the patient’s tubing set, such as a needle-free connector  100  depicted with reference to  FIG.  4   . Thus, the apparatus  10  may be installed on (e.g., attached to, engaged with, etc.) the needle-free connector  100 . An axially-movable cannula  20  protrudes from the apparatus  10  toward the socket  18  and is positioned to engage a seal on the needle-free connector  100 . A first fitting  22  disposed on the output side  14  in the socket  18  includes a female luer fitting in some embodiments. The first fitting  22  is configured to engage a corresponding fitting on the needle-free connector  100  to secure the needle-free connector to the apparatus  10 . A device window  24  is defined in the apparatus  10  adjacent to the socket  18 . The device window  24  provides access to the socket  18  for manipulating the needle-free connector  100  when received in the socket  18 . 
     Referring now to  FIGS.  2 - 3   , a partial cross-sectional view of the apparatus  10  is shown, according to some embodiments. As shown with reference to  FIG.  2   , the axially-movable cannula  20  includes an open bore  26  defined axially through the axially-movable cannula  20  from end to end. The bore  26  allows the flow of fluid through the axially-movable cannula  20 . The axially-movable cannula  20  has an input end oriented toward the input side  12 , and an output end oriented toward the output side  14 . The input side of the axially-movable cannula  20  includes a stem  28  having a tapered or reduced radial profile, according to some embodiments. 
     The axially-movable cannula  20  is housed in a fixed cannula  32  on a housing  30 . The fixed cannula  32  forms a cylindrical sleeve with an inner channel, and the axially-movable cannula  20  is at least partially positioned inside the inner channel of the fixed cannula  32 . The axially-movable cannula  20  is axially moveable inside apparatus  10  by translating back and forth inside the fixed cannula  32  on the housing  30 . A valve chamber  34  is defined in the fixed cannula  32  at an input end of the axially-movable cannula  20 . An input seal  36  is defined between the stem  28  and the fixed cannula  32  such that the stem  28  may slide axially relative to the fixed cannula  32  without leaking fluid in some embodiments. A valve (such as a valve  60  depicted with reference to  FIG.  6   ) is disposed in the valve chamber  34 . The valve  60  is a check valve in some embodiments. The valve  60  can include many forms such as but not limited to an ear plug valve, orchid type valve, duckbill valve, or any other suitable valve known in the art. 
     During use, the axially-movable cannula  20  may be depressed axially away from the needle-free connector  100  when joined, causing the stem  28  to translate toward and engage the valve contained in the valve chamber  34 . The engagement between the stem  28  on the axially-movable cannula  20  and the valve  60  causes the valve  60  to become opened, thereby allowing fluid to travel through inlet  19 , into the axially-movable cannula  20  and into the needle-free connector  100 . 
     An example of axial translation of the axially-movable cannula  20  is shown in the relative positioning of the axially-movable cannula  20  in  FIGS.  2 - 3   . In some embodiments, a valve chamber wall  37  is disposed in the fixed cannula  32  at an 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  when activated. The wall  37  includes openings or perforations to allow fluid flow from the inlet  19  into the bore  26  of the axially-movable cannula  20 , according to some embodiments. As described in greater detail below, the axially movable cannula may be separated from the needle-free connector  100  (a “separation event”). When the separation event occurs, the cannula is biased toward the output side and slides back away from the valve chamber to a position as shown in  FIG.  2   . 
     Referring to  FIG.  4   , the apparatus  10  is shown positioned for installation on the needle-free connector  100 , according to some embodiments. The needle-free connector  100  may include any conventional needle-free device, such as a B. Braun Caresite, a B. Braun Ultrasite, a BD Q-Syte, a BD MaxPlus, a BD MaxZero, an ICU Med MicroClave, an ICU Neutron, a Baxter One-Link, a RyMed Invision Plus, or any other suitable needle-free connector known in the art. In some embodiments, the needle-free connector  100  includes an interface  102  including a seal  108  (as shown with reference to  FIGS.  16 - 21   , according to varying arrangements). As examples, the seal  108  may include a septum-style seal, an accordion seal, a compressible sheath, a push seal, or any other suitable seal known in the art for a needle-free engagement. The needle-free connector  100  may also include a second fitting  103 , such as a male or female luer fitting configured to engage corresponding first fitting  22  on apparatus  10 . The needle-free connector  100  may also include a body  104  and a tubing junction  106  extending away from the needle-free connector  100  toward a patient. As described in greater detail below with reference to  FIGS.  16 - 21   , the apparatus  10  may accommodate various configurations of the needle-free connector  100 , and thus the embodiment of the needle-free connector  100  shown in  FIG.  4    (as well as  FIGS.  5 - 8    discussed below) is merely intended as a non-limiting example of the present disclosure. 
     Referring now to  FIGS.  5 - 7   , the needle-free connector  100  is joined directly to breakaway apparatus  10 , according to some embodiments. Referring particularly to  FIG.  5   , the engagement can be viewed through the device window  24 . The device window  24  also permits a user to manually twist or turn the needle-free connector  100  if necessary to engage the threaded luer fitting between the components. 
     Referring particularly to  FIGS.  6 - 7   , prior to installation of the apparatus  10  on the needle-free connector  100 , the interface  102  is positioned directly opposite the output end of axially-movable cannula  20 . From this position, the second fitting  103  engages with corresponding features on the first fitting  22 , thereby causing the axially-movable cannula  20  to penetrate the interface  102 , and simultaneously causing the stem  28  to advance into the valve chamber  34 , thereby activating and opening the valve  60 . The dual action of sliding the axially-movable cannula  20  provides simultaneous or near-simultaneous opening of the seal  108  on the needle-free connector  100  and opening of the valve  60  positioned in valve chamber  34 . 
     Referring further to  FIG.  6   , in some embodiments, the axially-movable cannula  20  includes a flange  21  protruding radially from the outer surface of the axially-movable cannula  20  outside of fixed cannula  32 . The flange  21  provides an axial stop for interface  102  or for other structural features on the needle-free connector  100 . When a structure on the needle-free connector  100  engages the flange  21 , relative travel between the axially-movable cannula  20  and the needle-free connector  100  stops, and the axially-movable cannula  20  is pushed by needle-free connector  100  toward the valve chamber  34 . As the stem  28  passes by the seal  36 , the stem  28  engages and opens the valve  60 . 
     In some embodiments, the axially-movable cannula  20  includes a barb  23  protruding from a portion of the axially-movable cannula  20  housed within the fixed cannula  32 . The barb  23  provides an axial stop for travel of the axially-movable cannula  20  in a direction away from the valve  60 . When the needle-free connector  100  is not engaged with the apparatus  10 , the axially-movable cannula  20  is biased away from the valve  60 , and the barb  23  engages a channel stop  38  to prevent the axially-movable cannula  20  from sliding too far out of an open end of the inner channel of the fixed cannula  32 . 
     Referring now to  FIG.  8   , the apparatus  10  is shown detached from the needle-free connector  100 , according to some embodiments. When a threshold tensile force associated with the separation event (e.g., a tensile force sufficient to effectuate the separation event) is applied to the IV line, the needle-free connector  100  and a breakaway component  50  may separate together as one unit from a shell  40  and a housing  30 . Upon the separation event, the axially-movable cannula  20  will automatically extend away from the valve  60  in the valve chamber  34  by force of the valve  60  pushing the axially-movable cannula  20  or by a coil spring or other biasing member in the fixed cannula  32 . Following separation, breakaway component  50  separates fully from shell  40 . 
     In some embodiments, one or more protrusions  52  extend from the breakaway component  50  in a direction away from the needle-free connector  100 . The protrusion(s)  52  provide a shield that prevents contamination of the interface  102  on the needle-free connector  100  by mechanically blocking access to the needle-free connector  100 . Following the separation event, the breakaway component  50  may be carefully removed from the needle-free connector  100  by unscrewing the threaded luer connection between the breakaway component  50  and the needle-free connector  100 . 
     The threshold tensile force associated with the separation event may be finely tuned by controlling the geometries of the components and the mechanical engagements between breakaway component  50  and shell  40 . For example, in some embodiments, the shell  40  includes one or more securing arms  42  extending toward the breakaway component  50 . Each of the securing arm(s)  42  include a flexible tip  44  angled radially away from the fixed cannula  32 . In further embodiments, the flexible tip  44  may be angled radially toward the fixed cannula  32  in a reversed configuration to achieve the same functionality. Each of the securing arm(s)  42  and the flexible tip(s)  44  may have an independent stiffness defined by material composition, thickness, shape and angle of orientation, among other parameters. Each of the securing arm(s)  42  may deflect toward the fixed cannula  32  as the flexible tip(s)  44  slide past a corresponding ramp  56  on the breakaway component  50  during the separation event, or in a reverse configuration may deflect away from the fixed cannula  32 . The inclined angle of the ramp(s)  56  also contribute to a tensile force required to disengage the breakaway component  50  from the apparatus  10 , and thus the threshold tensile force associated with the separation event. 
     In some embodiments, a square wall  58  oriented substantially perpendicular to the longitudinal direction of the apparatus  10  blocks the tips  44  in the event the device is attempted to be re-assembled from the configuration shown with reference to  FIG.  8   . This feature provides an anti-reconnection function that prevents the breakaway component  50  from being re-inserted into the shell  40 . This feature maintains sterility and forces a user to install a new sterile device following the separation event. 
     In some embodiments, one or more ramp windows  54  (e.g., slots) are aligned with a corresponding one or more openings  39  on the housing  30  (shown with reference to  FIG.  1   ), forming one or more keyholes, to provide access to the securing arms  42 . The keyhole access allows a tool to be inserted to depress the securing arms  42 , allowing the tips  44  to clear the wall  58  when the breakaway component  50  is initially installed in the shell  40  during manufacture. However, the design prevents a user from being able to deflect the securing arms  42  to attempt to re-connect a used device (e.g., following the separation event). 
     Referring now to  FIGS.  9 - 11   , the apparatus  10  includes the fixed cannula  32  with a compressible sheath  200  positioned over the fixed cannula  32 , according to some embodiments. The compressible sheath  200  includes an accordion-style compressible sheath formed from a flexible material, such as a plastic, silicone, polymer or elastomer. The compressible sheath  200   includes a seal  202 , which may include a split-septum style seal in some embodiments. The seal  202  is biased in a closed position. When the needle-free connector  100  is installed on the apparatus  10 , the interface  102  engages the seal  202  and pushes the compressible sheath  200  back over the fixed cannula  32 , thereby opening the seal  202  and allowing fluid to travel through the fixed cannula  32  and into the needle-free connector  100 . Referring particularly to  FIG.  10   , when the needle-free connector  100  is installed on the apparatus  10 , a distal end of the compressible sheath  200  penetrates the interface  102 , thereby deforming and opening the seal  108 . In such embodiments, the compressible sheath  200  may be dimensioned and shaped to provide adequate strength and resiliency to engage directly with the interface  102 . In other embodiments, the compressible sheath  200  may not be dimensioned and shaped to provide adequate strength and resiliency to engage directly with the interface  102 . In such cases, the interface  102  may push the compressible sheath  200  back over the fixed cannula  32 , such that, while still opening the seal  202 , the compressible sheath  200  does not mechanically engage the seal  108 . Accordingly, the fixed cannula  32  (now in direct engagement with the interface  102  due to the compressible sheath  200  being pushed back over the fixed cannula  32 ) may simultaneously (or near-simultaneously) penetrate the interface  102 , thereby deforming and opening the seal  108 . 
     When a separation event occurs, the compressible sheath  200  will spring back to its original shape covering fixed cannula  32  and causing the seal  202  to close, thereby stopping flow out of the fixed cannula  32 . The compressible sheath  200  includes the sheath flange  206  extending radially from the base of the compressible sheath  200  in some embodiments. The sheath flange  206  is clamped between the shell  40  and the housing  30 , according to some embodiments, in order to secure the axial position of the compressible sheath  200  on the fixed cannula  32 . The sheath  200  may take many shapes to achieve the desired functionality. 
     Referring particularly to  FIG.  11   , a bulkhead  210  is disposed on a distal end of the compressible sheath  200 , according to some embodiments. The bulkhead  210  includes an axisymmetric body having an outer wall in the shape of a smooth cylinder, according to some embodiments. In other embodiments, the bulkhead  210  includes other shapes and textures. The bulkhead  210  is formed of a rigid or semi-rigid material, and the bulkhead  210  engages with the needle-free connector  100  when installed on the apparatus  10 . The bulkhead  210  functions to translate axial force from the needle-free connector  100  onto the compressible sheath  200  in order to push the compressible sheath  200  backwards over the fixed cannula  32 , thereby opening fluid flow through the apparatus  10 . In such embodiments, the distal end of the compressible sheath  200  does not contact the interface  102  of the needle-free connector  100  directly, but instead the bulkhead  210  penetrates the interface  102  when the needle-free connector  100  is installed on apparatus  10 . The bulkhead  210  is not necessary in all embodiments, and may be omitted in embodiments where the compressible sheath  200  is dimensioned and shaped to provide adequate strength and resiliency to engage directly with the interface  102 , or where the needle-free connector  100  is configured such that the fixed cannula  32  engages the interface  102  as mentioned above. In further embodiments, the bulkhead  210  is integrally formed on the compressible sheath  200  as a one-piece construction. Additionally, in some embodiments, the bulkhead  210  is over-molded onto the compressible sheath  200  as a separate component. In other embodiments, the bulkhead  210  is a separate component press-fit onto the tip of the compressible sheath  200 . Multiple corresponding radial flanges are provided at the interface between the bulkhead  210  and the compressible sheath  200  in some embodiments. Each flange provides an axial stop to prevent the bulkhead  210  from sliding relative to the outer surface of the compressible sheath  200  when pushed by the needle-free connector  100 . 
     Referring now to  FIGS.  12 - 14   , the apparatus  10  is shown to include visual indicia, audio indicator(s), and/or batteries, according to various embodiments. As discussed above, the apparatus  10  may include the housing  30 , the shell  40  and the breakaway component  50 . The apparatus  10  may be configured to provide one or more visual indications to a user representative of a state condition of the connector. For example, the apparatus  10  may include one or more visual indicia  110  such as a light indicating a status of the apparatus  10 . The visual indicia  110  includes an LED light visible to a user in some embodiments. The LED light of the visual indicia  110  may be positioned on the housing  30 , the shell  40  or the breakaway component  50  (as shown with particular reference to  FIG.  14   ). In some embodiments, the LED light of the visual indicia  110  is positioned on the surface of the apparatus  10  to provide a visual indication of the status of the apparatus  10  (as shown with particular reference to  FIG.  12   ). 
     In some embodiments, the LED light of the visual indicia  110  may be configured to display a first color when the device is in a first condition, and a second color when the device is in a second condition. Additionally, the LED light of the visual indicia  110  may provide a blinking pattern to provide a status indicator of the apparatus  10 . The LED light of the visual indicia  110  may flash in a first color and pattern. The frequency of the light strobe may increase over time immediately after separation. In some embodiments, the LED light of the visual indicia  110  strobes at one flash every 3 seconds, after 5 minutes it increases to one flash every 2 seconds, after 15 minutes it flashes once every second, etc. After 30 minutes, the LED light of the visual indicia  110  may switch to a pattern of on for 1 second, two flashes/pulses, then back on for one second, and repeat. Various other combinations and patterns may be provided to indicate different state conditions to a user. 
     In some embodiments, the visual indicia  110  is mounted inside the apparatus  10  such that the visual indicia  110  is flush with the surface of the connector. In other embodiments, the connector material is translucent, and the visual indicia  110  is embedded within the apparatus  10  such that the light emitted from the LED light of the visual indicia  110  is visible through the material of the apparatus  10 . Alternatively, and referring particularly to  FIG.  13   , the visual indicia  110  may be positioned on an external structure attached to an exterior surface of the apparatus  10 . The LED light of the visual indicia  110  may be positioned on an exterior of a ring, and the ring may be installed onto the apparatus  10  as a separate component. 
     As mentioned above, the apparatus  10  may be configured to include one or more audio indicators. An audio indicator  112  may be configured to provide an auditory signal to a user indicative of a status condition of the apparatus  10 . The audio indicator  112  includes a speaker or electronic sound-generating component in some embodiments. The audio indicator  112  is positioned on or near the surface of component  10 , in some embodiments. The audio indicator  112  may be configured to emit one or more sounds (e.g., an audio alarm) to indicate a state of the apparatus  10 . In some embodiments, following a separate event, the audio alarm provides a first pattern of beeping followed by increasing the rate of the beeping over time. After a predetermined period of time, the audio indicator  112  may switch to different pattern instead of an overly repetitive/metronome like interval (for example beep ...... beep beep ...... beep ...... beep beep beep ..... ). 
     In some embodiments, apparatus  10  includes both the visual indicia  110  and the audio indicator  112 . In other embodiments, the apparatus  10  includes the visual indicia  110  and does not include the audio indicator  112 . In further embodiments, the apparatus  10  includes the audio indicator  112  and does not include the visual indicia  110 . Various other combinations of one or more visual indicators  110  and audio indicators  112  are provided within the scope of this disclosure. 
     As mentioned above with reference to  FIGS.  12 - 14   , the apparatus  10  may be configured to include one or more batteries. For example, the on-board electronics for the visual indicia  110  and the audio indicator  112  may powered by a battery  114 . The battery  114  may be positioned on or near the surface of apparatus  10  (as shown with particular reference to  FIG.  12   ). Alternatively, the battery  114  may be positioned on an external structure such a ring disposed on the apparatus  10  (as shown with particular reference to  FIG.  13   ). In some embodiments, the battery  114  is positioned in a rotational switch, such as a hexagonal component shown in  FIG.  13   , allowing a user to selectively engage or disengage the battery  114  from the electronics circuit. For example, following a separation event, the hexagonal rotational switch may be rotated to disconnect the battery  114 , thereby disabling the visual indicia  110  and/or the audio indicator  112  when the disconnected apparatus  10  is discarded. 
     Referring particularly to  FIG.  14   , the visual indicia  110 , the audio indicator  112 , and/or the batter  114  may be installed on the breakaway component  50 , according to some embodiments. As mentioned above with reference to  FIG.  1   , the apparatus  10  may include a first fitting  22 . In some embodiments, the breakaway component  50  includes a first fitting  22 , which is configured for attachment to the needle-free connector  100  on the patient’s tubing set. The breakaway component  50  may also include the ramp window(s)  54  and the ramp(s)  56 , which are configured to engage corresponding securing arm (s)  42  on the device. The breakaway component  50  may also include the protrusion(s)  52  extending in a direction away from the first fitting  22  to protect the passageway leading to the first fitting  22  and the seal  108  on the needle-free connector  100  when attached. The breakaway component  50 , in some embodiments, includes the aforementioned visual indicia  110 , which may include an LED light or other electronic component. The visual indicia  110  may be mounted on the body of the breakaway component  50  flush with the exterior surface, according to some embodiments. Alternatively, the visual indicia  110  may be located internal to the breakaway component  50 , and light from the LED shines through the material of the body of the breakaway component  50 . As a further alternative, the visual indicia  110  may be located on the external surface of the body of the breakaway component  50 . 
     In some embodiments, the breakaway component  50  includes the aforementioned audio indicator  112  configured to emit sound from the device when the breakaway component  50  is separated from the housing  30  and the shell  40 . The audio indicator  112  may be mounted flush with the surface of the breakaway component  50 , internal to the breakaway component  50 , or external to the breakaway component  50 , according to various embodiments. 
     In some embodiments, the breakaway component  50  includes the aforementioned battery  114 . When installed on the breakaway component  50 , the battery  114  may provide power to the visual indicia  110  and/or the audio indicator  112 . The battery  114  may be mounted flush with the surface of the breakaway component  50 , internal to the breakaway component  50 , or external to the breakaway component  50 , according to various embodiments. 
     Referring now to  FIG.  15   , the apparatus  10  is shown to include a compressible sheath, an axially-movable cannula, and/or a pull tab for operating a battery, according to various embodiments. As discussed above, the apparatus  10  includes the housing  30  attached to the shell  40 , and the breakaway component  50 , which is attached to the needle-free connector  100 , such that the apparatus  10  is installed on the needle-free connector  100 . The needle-free connector  100  includes the seal  108 . In some embodiments, the axially-movable cannula  20  is positioned to translate axially in the fixed cannula  32  adjacent to a valve that is formed by a compressible sheath  206  positioned on a hollow stem  208 . When the needle-free connector  100  is secured to the breakaway 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 . Simultaneously (or near-simultaneously), the axially-movable cannula  20  opens the seal  108  on the needle-free connector  100 . When the threshold tensile force required to actually separate the housing  30  and the shell  40  from the breakaway component  50  and the needle-free connector  100  attached thereto (e.g., effectuating the “separation event”) is applied, the axially-movable cannula  20  translates axially away from the housing  30 , thereby closing the valve formed by the compressible sheath  206  and the hollow stem  208 . Simultaneously (or near simultaneously), the axially-movable cannula  20  separates from the needle-free connector  100 , thereby closing the seal  108 . 
     In some embodiments, a pull tab  122  is fixed to the breakaway component  50  extending toward the housing  30 . Prior to the separation event, the pull tab  122  may reside in a battery housing  120  containing the battery  114 , thus separating the battery  114  from contacting a battery terminal. Accordingly, prior to the separation event, the battery  114  may be maintained in a zero discharge state disconnected from the electronic circuit for powering components such as visual and/or audio indicators (e.g., the visual indicia  110  and/or the audio indicator  112 ). For example, as shown with reference to  FIG.  12   , the visual indicia  110  and/or the audio indicator  112  may be housed on the housing  30  and/or the shell  40 . Upon a separation event, the pull tab  122  slides out of the battery housing  120 , thereby allowing the battery  114  to engage the electronic circuit onboard the apparatus  10  to provide power to the visual indicia  110  and/or the audio indicator  112 . As such, the pull tab  122  operates as a mechanical switch to prevent the battery  114  from contacting its battery terminal and powering the apparatus  10  prior to the separation event, but allowing the battery  114  to contact its battery terminal to power the apparatus  10  following the separation event. As such, the battery  114  may remain in place without discharging prior to the separation event, which may allow for a longer shelf life of the apparatus  10  without discharging the battery  114  before it is needed to power the visual indicia  110  and/or the audio indicator  112 . 
     As mentioned above with reference to  FIG.  13   , the visual indicia  110  and/or the audio indicator  112  may alternatively be housed on the breakaway component  50 . In such embodiments, the pull tab  122  may be positioned on the housing  30  or the shell  40  projecting toward the breakaway component  50 . Upon the separation event, the pull tab  122  disengages from a battery housing on the breakaway connector  50 . Thus, the shelf-life of the apparatus  10  may be two years or greater due to the pull tab  122  preventing contact between the battery  114  and a corresponding terminal in the electric circuit until a separation event occurs. 
     In some embodiments, the present disclosure provides a breakaway connector device with only one valve, configured for attachment to a needle-free connector. By providing a device with only one valve, the apparatus may take advantage of the seal on the needle-free connecter to function as a patient-side valve in a separation event. 
     In further embodiments, the present disclosure provides a method of securing an IV line using the devices disclosed herein. 
     Referring now to  FIGS.  16 - 21   , the apparatus  10  is shown being installed on the needle-free connector  100 , according to various embodiments of the present disclosure. As discussed in greater detail below, the apparatus  10  may be configured to accommodate various forces associated with components of the apparatus  10  and the needle-free connector  100 . In particular, the apparatus  10  may be configured to accommodate the various forces such that a threshold tensile force required to effectuate the separation event is within a desired range of separation forces. 
     As described above, when the apparatus  10  is installed on the needle-free connector  100 , the second fitting  103  of the needle-free connector  100  engages with corresponding features on the first fitting  22  of the apparatus  10 , thereby causing a component of the input side  12  (shown with reference to  FIG.  1   ) of the apparatus  10  to open the seal  108  of the needle-free connector  100 . As shown according to the various exemplary embodiments depicted herein, the needle-free connector  100  may include the body  104 , which houses the seal  108  and forms an outlet  109  within the tubing junction  106 . Thus, when the needle-free connector  100  is installed on the apparatus  10  as described herein, the seal  108  may be opened, and a fluid path may be opened from the inlet  19  to the outlet  109 . As a first example, as mentioned above with reference to  FIGS.  6 - 7  and  15   , and as described in greater detail below with reference to  FIGS.  16 - 17  and  20 - 21   , the axially-movable cannula  20  may open the seal  108 . As a second example, as mentioned above with reference to  FIGS.  9 - 11    and described in greater detail below with reference to  FIGS.  18 - 19   , the compressible sheath  200  and/or the fixed cannula  32  may open the seal  108 . Thus, the component of the input side  12  of the apparatus  10  that opens the seal  108  may be a feature of the housing  30  (e.g., the fixed cannula  32 ), or a component of the apparatus  10  that is engaged with the housing  30  when the apparatus  10  is installed on the needle-free connector  100  (e.g., the compressible sheath  200 , the fixed cannula  32 , and/or the axially movable cannula  20 ). 
     As described above, various components of the input side  12  may be advanced into the needle-free connector  100 , thus penetrating the interface  102  and opening the seal  108 , depending on the implementation of the present disclosure. When the seal  108  is opened by a component (“a penetrating component”) of the apparatus  10  as described herein, the seal  108  may correspondingly provide a push-out force on (e.g., push against) the penetrating component. For example, the seal  108  may be biased to a closed configuration (e.g., a configuration where fluid is not allowed to travel through the seal  108  and the outlet  109 ). As such, the seal  108  may be deformed (elastically, as an example) in order to reach an open configuration (e.g., a configuration where fluid is allowed to travel through the seal  108  and the outlet  109 ). Accordingly, while the seal  108  is deformed into the open configuration by the penetrating component, the seal  108  may correspondingly provide the push-out force as a result of being biased to return to a pre-deformed state (e.g., the closed configuration), thereby pushing the penetrating component away from the needle-free 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 apparatus  10  that is engaged with the housing  30  when the apparatus  10  is installed on the needle-free connector  100 . Thus, the push-out force may be imparted on the housing  30  by the needle-free connector  100 , acting to push the housing  30  away from the needle-free connector  100  while the apparatus  10  is installed on the needle-free connector  100 . 
     As discussed above with reference to  FIG.  8   , when the threshold tensile force associated with the separation event is applied to the IV line, the needle-free connector  100  and the breakaway component  50  may separate as one unit from the housing  30  and the shell  40 . However, a breakaway force that is distinct from the threshold tensile force may be required to separate only the breakaway component  50  from the housing  30  and the shell  40  (effectuating a “detachment event”). For example, the breakaway force associated with the detachment event may be tuned by controlling the geometries and the mechanical engagements between the breakaway component  50  and the shell  40 . Of course, the threshold tensile force associated with the separation event may be alternatively understood as the tensile force associated with the detachment event, with the further consideration of the push-out force provided by the needle-free connector  100 . Accordingly, in an exemplary scenario where the needle-free connector does not provide a push-out force, the threshold tensile force associated with the separation event would be equivalent to the breakaway force associated with the detachment event. However, as discussed herein, the needle-free connector  100  does in fact provide the push-out force when the apparatus  10  is installed on the needle-free connector  100 . 
     Accordingly, the threshold tensile force associated with the separation event may be a product, at least in part, of the push-out force and the breakaway force associated with the detachment event. For example, the push-out force may act to push the housing  30  away from the needle-free connector  100 , which is attached to the breakaway component  50 . Accordingly, the push-out force may push on the housing  30  in a manner that is in confluence with the threshold tensile force to be applied in order to effectuate the separation event. In other words, the threshold tensile force required to effectuate the separation event may be the breakaway force reduced by the push-out force. For example, if the breakaway force is about 10 pounds and the push-out force is about 6 pounds, the threshold tensile force required to effectuate the separation event may be about 4 pounds. 
     In some settings, it would be advantageous to provide the apparatus  10  such that the aforementioned threshold tensile force is within a desired range of separation force associated with the separation event. For example, the desired range of separation force may be a clinically acceptable range of acceptable tensile forces associated with detaching one end of the IV line (such as an end of the IV line attached to the input side  12  of the apparatus  10 ) from the other end of the IV line (such as an end of the line attached to the needle-free connector  100  and the pump side  14  of the apparatus  10 ). In this sense, a minimum (or lower end) of the desired range of separation force may be associated with ensuring that minor separation forces do not result in detaching one end of the IV line from the other end of the IV line. Here, cases of typical patient movement may advantageously not result in detaching one end of the IV line from the other end of the IV line. As a corollary, a maximum (or upper end) of the desired range of separation force may be associated with ensuring that substantial separation forces do in fact result in detaching one end of the IV line from the other end of the IV line. Here, cases of substantial (possibly inadvertent) separation forces, such as the patient jerking involuntarily during a procedure, may advantageously result in separating one end of the IV line from the other end of the IV line, thus avoiding harm to the patient that would otherwise occur should the IV line remain intact. 
     In some embodiments, the desired range of separation force is from about one pound to about six pounds. Such a desired range may be applicable to human patients. In other embodiments, the desired range of separation force is from about ten pounds to fifteen pounds. Such a desired range may be applicable to animal patients that may typically provide greater inadvertent separation forces on the IV line. In other embodiments still, the desired range of separation force is from about one pound to about fifteen pounds (thus corresponding to instances of both human patients and animal patients, as a non-limiting example). It should be appreciated that various desired ranges of separation force may be defined for various patient scenarios, and the examples provided for herein are not intended to limit the present disclosure to any particular range of separation force. 
     Accordingly, considering the desired range of separation forces discussed herein, the present disclosure provides for a method of using (e.g., a “use method”) a breakaway connector apparatus (such as the apparatus  10 ). The use method may include a first step of providing a breakaway connector including the housing  30  and the breakaway component  50 . As discussed above, the housing  30  may include the fixed cannula  32 , and the breakaway connector  50  may include a breakaway force associated with separation of the housing  30  and the shell  40  from the breakaway component  50  (e.g., imparting the “detachment” event). The use method may include a second step of providing the needle-free connector  100 . Of course, the needle-free connector  100  may include the seal  108  and a push-out force associated therewith. The use method may include a third step of installing the breakaway connector on the needle-free connector  100 , such that a fluid flow path is opened within the fixed cannula  32  and through the seal  108 . Thus, via the three use steps provided for herein, the breakaway connector may be installed on the needle-free connector  100 , such that the needle-free connector  100  imparts the push-out force on the housing  30 , and a sum of the breakaway force and the push-out force (e.g., the breakaway force reduced by the push-out force) is within the desired range of separation force associated with separating the housing  30  from the needle-free connector  100  (e.g., the separation event). 
     Moreover, the present disclosure thus provides for a breakaway connector apparatus (such as the apparatus  10 ) for attachment to a needle-free connector (such as the needle-free connector  100 ). The apparatus  10  may include a breakaway connector that includes the housing  30  (which includes the fixed cannula  32 ) and the breakaway component  50 , which are detachably secured to the housing  30 . The apparatus  10  may further include only one valve disposed within the fixed cannula  32 . For example, as shown with reference to  FIG.  6   , the apparatus  10  may include the single valve  60 . Additionally, the breakaway component may include the first fitting  22 , which is configured for engagement with the second fitting  103  disposed on the needle-free connector  100 , such that the needle-free fitting  100  imparts a push-out force on the housing  30 . Also, the breakaway connector  50  may include a breakaway force associated with separation of the breakaway component from the shell. Finally, a sum of the breakaway force and the push-out force may be within a desired range of separation force associated with separating the shell  40  from the needle-free fitting  100 . 
     As discussed in greater detail below, the needle-free connector  100  described herein may be embodied by any number of suitable needle-free connectors known in the art. Each of the various needle-free connectors that may embody the needle-free connector  100  may have a distinct push-out force associated therewith. For example, the push-out force associated with a known needle-free connector embodying the needle-free connector  100  may be measured and recorded prior to implementing the needle-free connector in a medical setting. Given the known push-out force of the embodying needle-free connector and the desired range of separation force, an appropriate implementation of the apparatus  10  may be selected in order to ensure that the resulting threshold tensile force that is required to impart the separation event is within the desired range of separation force. 
     As mentioned above, the needle-free connector  100  described herein may be embodied by any number of suitable needle-free connectors known in the art, each having a distinct push-out force associated therewith. As mentioned above with reference to  FIG.  4   , the needle-free connector  100  may be embodied by a B. Braun Caresite, a B. Braun Ultrasite, a BD Q-Syte, a BD MaxPlus, a BD MaxZero, an ICU Med MicroClave, an ICU Neutron, a Baxter One-Link, a RyMed Invision Plus, or any other suitable needle-free connector known in the art. In practical application, of course, the various embodying needle-free connectors may provide a range of push-out forces, depending on the particular embodying needle-free connector that is manufactured and provided for implementation on the IV line as described herein. Thus, as explained in greater detail below, the apparatus  10  may be provided (or selected from a number of devices embodying the apparatus  10 ), such that the breakaway force associated with the apparatus  10  accommodates the entire range of push-out forces associated with the embodying needle-free connector. 
     Advantageously, the particular push-out force associated with the embodying needle-free connector may not need to be measured prior to implementing the needle-free connector on the IV line. Rather, the various parameters associated with the push-out force (minimum push-out force, maximum push-out force, average push-out force, etc.) provided by the embodying needle-free connector may be known or identified and the apparatus  10  may be provided or selected based on such information. In some embodiments, the apparatus  10  (and the breakaway force associated therewith) is provided or selected based on a known or identified average (or median) push-out force provided by the embodying needle-free connector (among a manufactured sample of particular variety of embodying needle-free connectors, for example). In this sense, given a random embodying needle-free connector of a particular variety, there may be a likelihood that the resulting threshold tensile force associated required to impart the separation event would be safely within the desired range of separation force (towards a median or average of the desired range of separation force, for example). 
     As a first example, the B. Braun Caresite needle-free connector may, depending on the particular embodying needle-free connector manufactured and implemented, provide a push-out force as high as about 3.4 pounds, as low as about 2.3 pounds, and on average provide a push-out force of about 2.8 pounds. Thus, in order to accommodate attachment to the B. Braun Caresite needle-free connector for a desired range of separation force from about 1 pound to about 6 pounds, it may be advantageous to provide or select the apparatus  10  such that the apparatus  10  provides a breakaway force of about 6.3 pounds. Accordingly, the average B. Braun Caresite needle-free connector, when installed on the apparatus  10 , may result in a threshold tensile force of about 3.5 pounds (the 6.3-pound breakaway force reduced by the 2.8-pound average push-out force). In cases where the B. Braun Caresite needle-free connector provides a push-out force as high as about 3.4 pounds, the resulting threshold tensile force may be about 2.9 pounds (the 6.3-pound breakaway force reduced by the 3.4-pound maximum push-out force). In cases where the B. Braun Caresite needle-free connector provides a push-out force as low as about 2.3 pounds, the resulting threshold tensile force may be about 4 pounds (the 6.3-pound breakaway force reduced by the 2.3-pound minimum push-out force). Accordingly, the range of resulting threshold tensile forces associated with separating the housing  30  and the shell  40  from the breakaway component  50  and the needle-free connector  100  attached thereto may be from about 2.9 pounds to about 4 pounds, with an average of 3.5 pounds, thus situating the range of resulting threshold tensile forces required to impart the separation event within the desired range of separation force of from about 1 pound to about 6 pounds. 
     As a second example, the B. Braun Ultrasite needle-free connector may provide a push-out force as high as about 3.1 pounds, as low as about 1.9 pounds, and on average provide a push-out force of about 2.6 pounds. Thus, in order to accommodate attachment to the B. Braun Ultrasite needle-free connector for a desired range of separation force from about 1 pound to about 6 pounds, the apparatus  10  may be provided or selected such that the apparatus  10  provides a breakaway force of about 6.1 pounds. Accordingly, the average B. Braun Ultrasite needle-free connector, when installed on the apparatus  10 , may result in a threshold tensile force of about 3.5 pounds. In cases where the B. Braun Ultrasite needle-free connector provides a push-out force as high as about 3.1 pounds, the resulting threshold tensile force would be about 3 pounds. In cases where the B. Braun Ultrasite needle-free connector provides a push-out force as low as about 1.9 pounds, the resulting threshold tensile force would be about 4.2 pounds. Accordingly, the range of resulting threshold tensile forces required to impart the separation event may be from about 3 pounds to about 4.2 pounds, with an average of 3.5 pounds, thus situating the range of resulting threshold tensile forces required to impart the separation event within the desired range of separation force of from about 1 pound to about 6 pounds. 
     As a third example, the BD MaxPlus needle-free connector may provide a push-out force as high as about 3.6 pounds, as low as about 2.7 pounds, and on average provide a push-out force of about 3 pounds. Thus, in order to accommodate attachment to the BD MaxPlus needle-free connector for a desired range of separation force from about 1 pound to 6 pounds, the apparatus  10  may be provided or selected to provide a breakaway force of about 6.5 pounds. Accordingly, the BD MaxPlus needle-free connector, when installed on the apparatus  10 , may result in a threshold tensile force of about 3.5 pounds on average, as high as about 3.8 pounds, and as low as about 2.9 pounds, situating the range of resulting threshold tensile forces required to impart the separation event within the desired range of separation force from about 1 pound to about 6 pounds. 
     As a fourth example, the BD Q-Syte needle-free connector may provide a push-out force as high as about 6.7 pounds, as low as about 3.4 pounds, and on average provide a push-out force of about 5.1 pounds. Thus, in order to accommodate attachment to the BD Q-Syte needle-free connector for a desired range of separation force from about 1 pound to 6 pounds, the apparatus  10  may be provided or selected to provide a breakaway force of about 8.6 pounds. Accordingly, the BD Q-Syte needle-free connector, when installed on the apparatus  10 , may result in a threshold tensile force of about 2.5 pounds on average, as low as 1.9 pounds, and as high as about 3.4 pounds, situating the range of resulting threshold tensile forces required to impart the separation event within the desired range of separation force from about 1 pound to about 6 pounds. 
     As a fifth example, the ICU Med Microclave needle-free connector may provide a push-out force as high as about 3.1 pounds, as low about 2.5 pounds, and on average provide a push-out force of about 2.8 pounds. Thus, in order to accommodate attachment to the ICU Med Microclave needle-free connector for a desired range of separation force from about 1 pound to 6 pounds, the apparatus  10  may be provided or selected to provide a breakaway force of about 6.3 pounds. Accordingly, the ICU Med Microclave needle-free connector, when installed on the apparatus  10 , may result in a separation force of about 3.5 pounds on average, as low as about 3.2 pounds, and as high as about 3.8 pounds, situating the range of resulting threshold tensile forces required to impart the separation event within the desired range of separation force from about 1 pound to about 6 pounds. 
     As a sixth example, the ICU Neutron needle-free connector may provide a push-out force as high as about 3.1 pounds, as low as about 2.6 pounds, and on average provide a push-out force of about 2.9 pounds. Thus, in order to accommodate attachment to the ICU Neutron needle-free connector for a desired range of separation force from about 1 pound to 6 pounds, the apparatus  10  may be provided or selected to provide a breakaway force of about 6.4 pounds. Accordingly, the ICU Neutron needle-free connector, when installed on the apparatus  10 , may result in a separation force of about 3.5 pounds on average, as low as about 3.3 pounds, and as high as about 3.8 pounds, situating the range of threshold tensile forces required to impart the separation event within the desired range of separation force from about 1 pound to about 6 pounds. 
     As a seventh example, the Baxter One-Link needle-free connector may provide a push-out force as high as about 2 pounds, as low as about 1 pound, and on average provide a push-out force of about 1.6 pounds. Thus, in order to accommodate attachment to the Baxter One-Link needle-free connector for a desired range of separation force from about 1 pound to 6 pounds, the apparatus  10  may be provided or selected to provide a breakaway force of about 5.1 pounds. Accordingly, the Baxter One-Link needle-free connector, when installed on the apparatus  10 , may result in a separation force of about 3.5 pounds on average, as low as about 3.1 pounds, and as high as about 4.1 pounds, situating the range of resulting threshold tensile forces required to impart the separation event within the desired range of separation force from about 1 pound to about 6 pounds. 
     As an eighth example, the RyMed Invision Plus needle-free connector may provide a push-out force as high as about 2 pounds, as low as about 1 pound, and on average provide a push-out force of about 1.5 pounds. Thus, in order to accommodate attachment to the RyMed Invision Plus needle-free connector for a desired range of separation force from about 1 pound to 6 pounds, the apparatus  10  may be provided or selected to provide a breakaway force of about 5 pounds. Accordingly, the RyMed Invision Plus needle-free connector, when installed on the apparatus  10 , may result in a separation force of about 3.5 pounds on average, as low as about 3 pounds, and as high as about 4 pounds, situating the range of resulting threshold tensile forces required to impart the separation event within the desired range of separation force from about 1 pound to about 6 pounds. 
     Referring particularly to  FIGS.  16 - 17   , the apparatus  10  is shown being installed on the needle-free connector  100 , according to some embodiments of the present disclosure.  FIGS.  16 - 17    depict this installation with an embodiment of the apparatus  10  that includes the axially-movable cannula  20  housed in the fixed cannula  32  on the housing  30 , as discussed above with reference to  FIGS.  6 - 7   . In the exemplary embodiments shown, the needle-free connector  100  includes the seal  108  operating as an accordion seal or a compressible sheath (e.g., an accordion-style compressible sheath) with a split-septum style tip, which is biased to a closed configuration. The seal  108  may be deformed to reach an open configuration by the axially-movable cannula  20  of the apparatus  10  (in other words, the “penetrating component” discussed above is the axially-movable cannula  20 ). In such embodiments, the seal  108  may be formed from a flexible material, such as a plastic, silicone, polymer, or elastomer. 
     According to some embodiments,  FIG.  16    depicts the apparatus  10  and the needle-free connector  100  prior to installation of the apparatus  10  on the needle-free connector  100 , while  FIG.  17    depicts the apparatus  10  and the needle-free connector  100  when the apparatus  10  is installed on the needle-free connector  100 , thus deforming the seal  108  to reach an open configuration. As shown with particular reference to  FIG.  17   , the second fitting  103  of the needle-free connector  100  may engage with corresponding features on the first fitting  22 , thereby causing the axially-movable cannula  20  to penetrate the interface  102  of the needle-free connector  100 . When the axially-movable cannula  20  penetrates the interface  102 , the axially-movable cannula  20  may then engage and deform the seal  108 , pushing the seal  108  towards the outlet  109 , thereby opening the split-septum style tip of the seal  108  and opening a fluid path from the interface  102  to the outlet  109 . Simultaneously (or near-simultaneously), the axially-movable cannula  20  may be advanced toward the inlet  19 , thus causing the stem  28  to advance into the valve chamber  34 , thereby activating and opening the valve  60  within the valve chamber  34  (as discussed above with reference to  FIGS.  6 - 7   ) and opening a fluid path from the inlet  19  to the axially-movable cannula  20 . Thus, a fluid path may be opened from the inlet  19  of the apparatus  10  to the outlet  109  of the needle-free connector  100 . 
     As suggested above, when the seal  108  is deformed to reach an open configuration by the axially-movable cannula  20 , the seal  108  may correspondingly provide a push-out force on the axially-movable cannula  20  as a result of being biased to return to a closed configuration, thereby pushing the axially-movable cannula  20  away from the needle-free connector  100  and toward the housing  30 . In some embodiments, the push-out force is transferred by the axially-movable cannula  20  to the housing  30 , such that, overall, the seal  108  imparts the push-out force on the housing  30 . As an example, when the stem  28  activates and opens the valve  60 , the valve  60  may be biased against the valve chamber  34  of the housing  30  towards the inlet  19 . As another example, when the axially-movable cannula  20  is advanced toward the inlet  19 , an outer surface of the axially-movable cannula  20  may provide a frictional force on an inner surface of the fixed cannula  32  of the housing  30  in the direction of the inlet  19 . As another example still, in order for the stem  28  to activate and open the valve  60 , the stem  28  may push against, or provide a frictional force against, the input seal  36  of the housing  30  towards the inlet  19 . Thus, the seal  108  may impart the overall push-out force on the housing  30 . Accordingly, in some embodiments, and as discussed above, the threshold tensile force required to effectuate the separation event may be the breakaway force (which may be tuned by controlling the geometries and the mechanical engagements between the breakaway component  50  and the shell  40  of the apparatus  10 , as mentioned above with reference to  FIG.  8   ), reduced by the push-out force. 
     In other embodiments, however, the threshold tensile force required to effectuate the separation event may be the breakaway force reduced by the push-out force, additionally increased by a biasing force imparted by the apparatus  10 . For example, when the stem  28  activates and opens the valve  60 , the valve  60  may provide a biasing force against the stem  28 , therefore pushing the axially-movable cannula  20  toward the needle-free connector  100 . Thus, where the valve  60  provides such a biasing force against the stem  28 , the threshold tensile force required to effectuate the separation event may then be the breakaway force reduced by the push-out force, additionally increased by the biasing force provided by the valve  60  of the apparatus  10 . 
     As mentioned above, given the known push-out force of the needle-free connector  100  as depicted with reference to  FIGS.  16 - 17   , and a desired range of separation force, an appropriate implementation of the apparatus  10  may be provided in order to ensure that the resulting threshold tensile force that is required to impart the separation event is within the desired range of separation force. 
     Referring particularly to  FIGS.  18 - 19   , the apparatus  10  is shown being installed on the needle-free connector  100 , according to some embodiments of the present disclosure.  FIGS.  18 - 19    depict this installation with an embodiment of the apparatus  10  that includes the compressible sheath  200  positioned over the fixed cannula  32 , as discussed above with reference to  FIGS.  9 - 11   . In the exemplary embodiments shown, the needle-free connector  100  includes the seal  108  operating as a push seal, which is biased to a closed configuration. The seal  108  may be deformed to reach an open configuration by the compressible which is biased to a closed position and is opened by the compressible sheath  200  of the apparatus  10 . In such embodiments, the seal  108  may be formed from a flexible material, such as a plastic, silicone, polymer, or elastomer. 
     According to some embodiments,  FIG.  18    depicts the apparatus  10  and the needle-free connector  100  prior to installation of the apparatus  10  on the needle-free connector  100 , while  FIG.  19    depicts the apparatus  10  and the needle-free connector  100  when the apparatus  10  is installed on the needle-free connector  100 , thus opening the seal  108  of the needle-free connector  100 . As shown with particular reference to  FIG.  19   , the second fitting  103  of the needle-free connector  100  engages with corresponding features on the first fitting  22 , thereby causing the compressible sheath  200  to engage the interface  102 . 
     In some embodiments, as discussed in greater detail above with reference to  FIGS.  9 - 11    and as shown with reference to  FIG.  19   , the compressible sheath  200  may not be dimensioned and shaped to provide adequate strength and resiliency to penetrate the interface  102 . In such embodiments, when the compressible sheath  200  engages the interface  102 , the interface  102  may push the compressible sheath  200  back over the fixed cannula  32 , thereby opening the seal  202  and allowing fluid to travel from the inlet  19  through the fixed cannula  32 . Simultaneously (or near-simultaneously), the fixed cannula  32  may penetrate the interface  102  in order to engage and deform the seal  108 , thereby allowing fluid to travel from the interface  102  to the outlet  109  (in other words, the “penetrating component” discussed above is the fixed cannula  32 ). Thus, a fluid path may be opened from the inlet  19  to the outlet  109 . 
     In other embodiments, as discussed in greater detail above with reference to  FIGS.  9 - 11   , the compressible sheath  200  may be dimensioned and shaped to provide adequate strength and resiliency to engage directly with the interface  102 . In such embodiments, when the needle-free connector  100  is installed on the apparatus  10 , a distal end of the compressible sheath  200  may engage the interface  102 , thereby opening the seal  202  and allowing fluid to travel from the inlet  19  through the compressible sheath  200 . Simultaneously (or near-simultaneously), the distal end of the compressible sheath  200  may penetrate the interface  102  in order to engage end deform the seal  108 , thereby allowing fluid to travel from the interface  102  to the outlet  109  (in other words, the “penetrating component” discussed above is the compressible sheath  200 ). Thus, a fluid path may be opened from the inlet  19  to the outlet  109  of the needle-free connector  100 . 
     As suggested above, when the seal  108  is deformed to reach an open configuration opened by the compressible sheath  200  and/or the fixed cannula  32 , the seal  108  may correspondingly provide a push-out force on the compressible sheath  200  and/or the fixed cannula  32  as a result of being biased to return to a closed configuration. 
     In some embodiments where the compressible sheath  200  is pushed back over the fixed cannula  32  such that the compressible sheath  200  does not penetrate the interface  102  (as shown with reference to  FIG.  19   ), the push-out force may be imparted (in portions, for example) on both the compressible sheath  200  (which transfers the push-out force to the housing  30 ) and the fixed cannula  32  of the housing  30  (as well as the bulkhead  210 , in some cases). As a first example, when the compressible sheath  200  is pushed back over the fixed cannula  32 , the compressible sheath  200  may become compressed, thus transferring a first portion of the push-out force to the housing  30  at or near the base of the fixed cannula  32  (e.g., where the compressible sheath  200  forms the sheath flange  206 ). As a second example, the seal  108  may impart a second portion of the push-out force directly on the fixed cannula  32  of the housing  30  due to the mechanical engagement between the fixed cannula  32  and the seal  108  that opens the seal  108 . Thus, the seal  108  may impart the overall push-out force on the housing  30 . 
     In other embodiments where the compressible sheath  200  does penetrate the interface  102 , the push-out force may be imparted on the compressible sheath  200 , which transfers the push-out force to the housing  30 . For example, the compressible sheath  200  may become compressed, thus transferring the push-out force to the housing  30  at or near the base of the fixed cannula  32  (e.g., where the compressible sheath  200  forms the sheath flange  206 ). Thus, the seal  108  may impart the overall push-out force on the housing  30 . 
     Accordingly, in some embodiments, and as discussed above, the threshold tensile force required to effectuate the separation event may be the breakaway force (which may be tuned by controlling the geometries and the mechanical engagements between the breakaway component  50  and the shell  40  of the apparatus  10 , as mentioned above with reference to  FIG.  8   ), reduced by the push-out force. 
     In other embodiments, however, the threshold tensile force required to effectuate the separation event may be the breakaway force reduced by the push-out force, additionally increased by a biasing force imparted by the apparatus  10 . For example, when the compressible sheath  200  is pushed back over the fixed cannula  32 , the compressible sheath  200  may become compressed, thus providing a biasing force against the interface  102 . Thus, where the compressible sheath  200  provides such a biasing force against the interface  102 , the threshold tensile force required to effectuate the separation event may then be the breakaway force reduced by the push-out force, additionally increased by the biasing force provided by the compressible sheath  200  of the apparatus  10 . 
     As mentioned above, given the known push-out force of the needle-free connector  100  as depicted with reference to  FIGS.  18 - 19   , and a desired range of separation force, an appropriate implementation of the apparatus  10  may be provided in order to ensure that the resulting threshold tensile force that is required to impart the separation event is within the desired range of separation force. 
     Referring particularly to  FIGS.  20 - 21   , the apparatus  10  is shown being installed on the needle-free connector  100 , according to some embodiments of the present disclosure.  FIGS.  20 - 21    depict this installation with an embodiment of the apparatus  10  that includes the axially-movable cannula  20  positioned to translate axially in the fixed cannula  32  adjacent to a valve that is formed by the compressible sheath  206  positioned on the hollow stem  208 , as discussed above with reference to  FIG.  15   . In the exemplary embodiments shown, the needle-free connector  100  includes the seal  108  with a v-shaped seam. The v-shaped seam may be biased to an open position, while the surrounding material of the seal  108  compresses the v-shaped seam to a closed position and is biased to retain the v-shaped seam near the interface  102 , as shown with particular reference to  FIG.  20   . The seal  108  may be deformed to reach an open configuration by the axially-movable cannula  20  of the apparatus  10  (in other words, the “penetrating component” discussed above is the axially-movable cannula  20 ). In such embodiments, the v-shaped seam within the seal  108  may be formed of a rigid material such as nylon or plastic, while the remaining portions of the seal  108  may be formed from a flexible material, such as a plastic, silicone, polymer, or elastomer. 
     According to some embodiments,  FIG.  20    depicts the apparatus  10  and the needle-free connector  100  prior to installation on the apparatus  10  to the needle-free connector  100 , while  FIG.  21    depicts the apparatus  10  and the needle-free connector  100  when the apparatus  10  is installed on the needle-free connector  100 , thus deforming the seal  108  to reach an open configuration. As shown with particular reference to  FIG.  21   , the second fitting  103  of the needle-free connector  100  may engage with corresponding features on the first fitting  22 , thereby causing the axially-movable cannula  20  to penetrate the interface  102  of the needle-free connector  100 . When the axially-movable cannula  20  penetrates the interface  102 , the axially-movable cannula  20  may then engage the v-shaped seam within the seal  108 , deforming the surrounding material of the seal  108  and pushing the v-shaped seam away from the interface  102  and towards the outlet  109 , such that the v-shaped seam is allowed to open therefore allowing the v-shaped seam to move the seal  108  into an open configuration. Accordingly, a fluid path may be opened from the interface  102  to the outlet  109 . Simultaneously (or near-simultaneously), 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  and opening a fluid path from the inlet  19  to the axially movable cannula  20  (as discussed above with reference to  FIG.  15   ). Thus, a fluid path may be opened from the inlet  19  of the apparatus  10  to the outlet  109  of the needle-free connector  100 . 
     As suggested above, when the seal  108  is deformed to reach an open configuration by the axially-movable cannula  20 , the surrounding material of the seal  108  is biased to move the v-shaped seam away from the outlet  109  such that the v-shaped seam is retained near the interface  102 . Thus, the seal  108  may correspondingly provide a push-out force on the axially-movable cannula  20  as a result of being biased to return to a closed configuration, thereby pushing the axially-movable cannula  20  away from the needle-free connector  100  and toward the housing  30 . In some embodiments, the push-out force is transferred by the axially-movable cannula  20  to the housing  30 , such that, overall, the seal  108  imparts the push-out force on the housing  30 . As an example, when the axially-movable cannula  20  compresses the compressible sheath  206 , the compressible sheath  206  may, in turn, push against the housing  30  in the direction of the inlet  19 . As another example, when the axially-movable cannula  20  is advanced toward the inlet  19 , an outer surface of the axially-movable cannula  20  may provide a frictional force on an inner surface of the fixed cannula  32  of the housing  30  in the direction of the inlet  19 . Thus, the seal  108  may impart the overall push-out force on the housing  30 . Accordingly, in some embodiments, and as discussed above, the threshold tensile force required to effectuate the separation event may be the breakaway force (which may be tuned by controlling the geometries and the mechanical engagements between the breakaway component  50  and the shell  40  of the apparatus  10 , as mentioned above with reference to  FIG.  8   ), reduced by the push-out force. 
     In some embodiments, however, the threshold tensile force required to effectuate the separation event may be the breakaway force reduced by the push-out force, additionally increased by a biasing force imparted by the apparatus  10 . For example, when the axially-movable cannula  20  compresses the compressible sheath  206 , the compressible sheath  206  may provide a biasing force against the axially-movable cannula  20 , therefore pushing the axially-movable cannula  20  toward the needle-free connector  100 . Thus, where the compressible sheath  206  provides such a biasing force against the axially-movable cannula  20 , the threshold tensile force required to effectuate the separation event may then be the breakaway force reduced by the push-out force, additionally increased by the biasing force provided by the compressible sheath  206  of the apparatus  10 . 
     Referring now to  FIG.  22   , the apparatus  10  is shown detached from the needle-free connector  100 , according to some embodiments. In the exemplary embodiments shown, the needle-free connector  100  includes the seal  108  operating as an accordion seal or a compressible sheath (e.g., an accordion-style compressible sheath) with a split-septum style tip as discussed above with reference to  FIGS.  16 - 17   . When a threshold tensile force associated with the separation event is applied to the IV line, the needle-free connector  100  and a breakaway component  50  may separate together as one unit from the shell  40  and the housing  30 . Upon the separation event, the axially-movable cannula  20  may automatically extend away from the valve  60  in the valve chamber  34  by force of the valve  60  pushing the axially-movable cannula  20  or by a coil spring or other biasing member in the fixed cannula  32 . Following separation, the breakaway component  50  separates fully from the shell  40 . 
     Referring now to  FIG.  23   , a kit  300  of breakaway connector apparatuses is shown, according to some embodiments. As mentioned above, given a known push-out force (or statistical parameters associated therewith) associated with a needle-free connector, one of multiple breakaway connector apparatuses provided in the kit  300  may be selected in order to ensure that, when the selected breakaway connector apparatus is attached to the needle-free connector, the resulting threshold tensile force sufficient to effectuate the separation event is within the desired range of separation force. 
     In some embodiments, the kit  300  includes two or more breakaway connector apparatuses as described herein. However, the breakaway connector apparatus may provide varying breakaway forces associated therewith. For example, the kit  300  may include the apparatus  10 , as well as a breakaway connector apparatus (apparatus)  310 , which, in a corresponding fashion apparatus  10 , includes a housing  330 , a shell  340 , a fitting  322 , a breakaway component  350 , and an axially-movable cannula  320 . 
     As mentioned above, the breakaway force associated with an embodiment of the apparatus  10  may be tuned by controlling the geometries and the mechanical engagements between the breakaway component  50  and the shell  40 . Similarly, the breakaway force associated with the apparatus  310  may be tuned by controlling the geometries and the mechanical engagements between the breakaway component  350  and the housing  340 . Thus, multiple implementations of the apparatus  10  may be provided with varying breakaway forces included therewith that are known to a user of the kit  300 . It should be appreciated that, while the kit  300  as depicted includes two breakaway connector apparatuses, the kit  300  can include any number of breakaway connector apparatuses in order to provide a wide range of associated breakaway forces that can be applied to various needle-free fittings in order to achieve threshold tensile forces that satisfy varying desired ranges of separation force associated with the separation event. 
     Accordingly, given the multiple implementations of the apparatus  10  that may be provided with various breakaway forces associated therewith, the present disclosure provides for a method of selecting a breakaway connector device (such as the apparatus  10  and the apparatus  310 ) for attachment to a needle-free connector (such as the needle-free connector  100 ) on an IV line (e.g., a “selection method”). The selection method may include a first step of providing the needle-free connector  100  for attachment to a breakaway connector. For example, the needle-free connector  100  may be acquired, or already installed on the IV line at the inception of the selection method. Of course, the needle-free connector  100  may have a push-out force associated therewith. The selection method may include a second step of identifying the push-out force imparted by the needle-free connector  100 . For example, the push-out force may be identified by measuring the push-out force directly, or the push-out force (or statistical parameters associated therewith) may simply be known (e.g., on record as associated with the particular embodiment of the needle-free connector  100 ). In this sense, the push-out force may be measured or known as a value such as about 2 pounds, as an example. 
     The selection method may include a third step of identifying a desired range of separation force associated with separating a first portion of the IV line (such as the input side  12 ) from a second portion of the IV line (such as the output side  14 ). For example, the desired range of separation force may be from about 1 pound to about 6 pounds. The selection method may include a fourth step of selecting a breakaway connector device (e.g., the apparatus  10 , the apparatus  310 , etc.), such that a sum of the breakaway force and the push-out force (e.g., the breakaway force reduced by the push-out force) is within the desired range of separation force. As a non-limiting example, the apparatus  10  may include a breakaway force of about 5 pounds, and the apparatus  310  may include a breakaway force of about 10 pounds. Thus, attaching the apparatus  10  would result in a threshold tensile force sufficient for a separation event of about 3 pounds, while the apparatus  310  would result in a corresponding threshold tensile force of about 8 pounds, in this non-limiting example. Accordingly, the apparatus  10  may be selected, since the resulting threshold tensile force sufficient for a separation event of about 3 pounds is within the desired range of separation force, while the corresponding threshold tensile force of about 8 pounds is not. 
     Moreover, the present disclosure thus provides for a kit, such as the kit  300 , for attaching a breakaway connector device to a needle-free connector (such as the needle-free connector  100 ) that imparts a push-out force. The kit  300  may include a first breakaway connector, such as the apparatus  10 , having a first housing (the housing  30 ) and a first breakaway component (the breakaway component  50 ). The apparatus  10  thus provides a first breakaway force associated with separation of the first housing from the first breakaway component. The kit  300  may further include a second breakaway connector, such as the apparatus  310 , having a second housing (the housing  330 ) and a second breakaway component (the breakaway component  350 ). The apparatus  310  thus provides a second breakaway force associated with separation of the second housing from the second breakaway component. Due to the aforementioned tuning that may differentiate breakaway forces between various breakaway connector apparatuses, the second breakaway force may be different than the first breakaway force. Each of the apparatuses  10 ,  310  are configured for attachment to the needle-free connector  310 , and at least one of the first breakaway force and the second breakaway force, when combined with the push-out force imparted by the needle-free fitting  100 , provides a sum that is within a desired range of separation force associated with separating the first housing or the second housing, respectively, from the needle-free fitting  100 . 
     Thus, although there have been described particular embodiments of the present invention of new and useful devices and methods, it is not intended that such references be construed as limitations upon the scope of this invention except as set forth in the claims.