Patent Application
20230149689
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.
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.
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
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
Referring now to
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
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
Referring to
Referring now to
Referring particularly to
Referring further to
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
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
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
Referring now to
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
Referring now to
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
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
Referring particularly to
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
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
As mentioned above with reference to
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
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
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
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
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
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
According to some embodiments,
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
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
Referring particularly to
According to some embodiments,
In some embodiments, as discussed in greater detail above with reference to
In other embodiments, as discussed in greater detail above with reference to
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
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
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
Referring particularly to
According to some embodiments,
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
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
Referring now to
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.
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.
| Number | Date | Country | |
|---|---|---|---|
| 63231020 | Aug 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17884391 | Aug 2022 | US |
| Child | 18097254 | US |
