CN111867669B

CN111867669B - Medical tube connector apparatus and method of coupling detachable line connectors

Info

Publication number: CN111867669B
Application number: CN201980019949.7A
Authority: CN
Inventors: 史宾塞·琼斯; 凡斯·克莱门特; 乔丹·麦克莱比
Original assignee: Seth Safu Ltd By Share Ltd
Current assignee: Seth Safu Ltd By Share Ltd
Priority date: 2018-01-17
Filing date: 2019-01-17
Publication date: 2022-08-09
Anticipated expiration: 2039-01-17
Also published as: CN111867669A; AU2019209934A1; JP2021511146A; KR20200120911A; JP7095097B2; BR112020014575A2; CN115253060A; CA3088802A1; WO2019143848A1

Abstract

A medical tube connector apparatus and method of coupling a detachable line connector are disclosed. A split medical tube connector apparatus for joining two portions of a medical tube includes a pump-side component and a patient-side component positioned axially opposite the pump-side component. The pump-side member has: a first passage disposed in the pump-side member; and a first valve disposed within the first passage. The patient side member has: a second channel disposed within the patient-side component; and a second valve disposed within the second passage. The first valve may be an active valve and the second valve may be a passive valve. To provide a detachable coupling of the two parts, the fixation rod may be arranged on the pump-side part and the fixation arm may be arranged on the patient-side part.

Description

Medical tube connector apparatus and method of coupling detachable line connectors

Technical Field

The present disclosure relates generally to connectors for intravenous medical tubing. More particularly, the present disclosure relates to self-sealing separable intravenous line connectors.

Background

In a medical environment, medical tubes are commonly used to deliver fluids to or from a patient. Intravenous technology and techniques have evolved to the point where the various devices associated with intravenous applications are delicate and often forgotten by the patient. Thus, it is not uncommon for a patient to attempt a movement that is limited by the medical tube and the device to which the ends of the medical tube are connected. This is often uncomfortable, painful for the patient and can even present a hazard to the patient in the event that the access point to the patient's vein is damaged. This can cause severe bruising, tearing, and even bleeding. This is particularly dangerous for the patient if the access point is a main vein, artery or organ.

In the event that the access point is damaged by accidental movement, this may result in an unsanitary and hazardous environment as the patient may bleed and fluids collected or introduced into the patient will be poured from the storage container. The patient may panic and attempt to re-establish the connection, which may be dangerous due to the risk of contamination of the line, which may be extremely dangerous for the patient, and the patient has not been trained to perform such tasks. When disconnection occurs, the lines, insertion points, and fluids may have become contaminated, and if the patient is able to reestablish the lines, the patient may carry pathogens and other contaminants directly into the body. This can lead to serious and fatal infections and other serious complications.

There is thus a need for improved devices and methods for preventing accidental removal of an intravenous insertion site and a separate medical tube connector.

Disclosure of Invention

This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

One aspect of the present disclosure is a breakaway connector apparatus for placement between two medical tubing sets. Generally in current medical practice, there are devices or tubes inserted inside the patient's body which, after exiting from the patient's body, present a device for connecting the outer sections of the tubes. Auxiliary containers for infused fluids or containers for expelled fluids, sometimes with a pumping mechanism along the tubing between the container and the patient. The connection point between these respective medical tube sections is of utmost importance, since it provides an entry point for pathogens and is usually in close proximity to the patient, and thus near the insertion site.

The present disclosure allows for a sealed fluid connection between two connectors of a medical tube, but allows the tube segments to disengage from each other upon application of a particular threshold tension or threshold range before failure of the adhesive or securement device, ultimately preventing the adverse event of premature removal of the device. The two ends of the device, still attached to the respective sides of the tube, act as a protective barrier to external pathogens and also block fluid flow to act as a barrier for fluid leakage from the patient or ultimately from the container. The device may be attached only with specific tools that are able to access the mechanism for attachment within the device.

Numerous other objects, advantages and features of the present disclosure will become readily apparent to those skilled in the art upon review of the following drawings and description of the preferred embodiments.

Drawings

FIG. 1 is a diagram of an embodiment of an exemplary apparatus in use.

FIG. 2 is a view of an embodiment of an exemplary apparatus after separation in use.

FIG. 3 is a perspective view of an embodiment of an exemplary apparatus.

FIG. 4 is a cross-sectional side view of an embodiment of an exemplary apparatus.

FIG. 5 is an elevation view of an exemplary pump side member having a first valve disposed therein.

Fig. 6 is a front view of an exemplary patient-side component with a second valve disposed therein.

FIG. 7 is a cross-sectional side view of an exemplary embodiment of a first valve disposed in a pump-side component.

Fig. 8 is a cross-sectional side view of an exemplary embodiment of a second valve disposed in a patient-side component.

Fig. 9 is a perspective view of an exemplary embodiment of a pump-side component and a patient-side component when decoupled.

Fig. 10 is a cross-sectional perspective view of an exemplary embodiment of a pump-side component and a patient-side component when decoupled.

FIG. 11 is an exploded perspective view of an exemplary embodiment of an apparatus.

FIG. 12 is a cross-sectional side view of an exemplary embodiment of an anti-reattachment device.

FIG. 13 is a cross-sectional perspective view of an exemplary embodiment of a keyway arrangement.

FIG. 14 is a cross-sectional perspective view of an exemplary embodiment of a keyway device coupled with a re-connect prevention device.

FIG. 15 is a cross-sectional side view of an exemplary embodiment of a pump-side component.

FIG. 16 is a cross-sectional perspective view of an exemplary embodiment of a snap-fit connection.

Figures 17a to 17f are cross-sectional side views of an embodiment of a snap-fit connection and anti-reattachment means when an axial force is applied to the device.

Figures 18a to 18e are close-up cross-sectional side views of an embodiment of a snap-fit connection and anti-reattachment means when an axial force is applied to the device.

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 which can be 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 present 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 the invention and are covered by the claims.

In the drawings, not all reference numerals are included in each figure for clarity. In addition, positional terms such as "upper," "lower," "side," "top," "bottom," and the like refer to the apparatus in the orientation depicted in the drawings or otherwise described. Those skilled in the art will recognize that the apparatus may assume different orientations when in use.

With further reference to the drawings, fig. 1 shows an exemplary application of a patient safety disconnect-type or disconnect-type medical tube connector apparatus (apparatus) 10 positioned on a medical line. The apparatus 10 may be used in any suitable medical gas, fluid or solid delivery, extraction or monitoring line, such as an Intravenous (IV) line. In some embodiments, the apparatus 10 includes a pump-side component 12 and a patient-side component 14. The apparatus 10 is configured to decouple upon application of a threshold amount of tensile force in opposite axial directions along the apparatus 10 to cause the pump-side component 12 to separate from the patient-side component 14. As seen in fig. 1, a delivery site 100, such as a catheter or other intravenous needle device, is located on a patient 102. A first line 104 extends between the apparatus 10 and a source or sink of fluid, gaseous or solid material moving through the line. The first line 104 has a free end coupled to the device 10. A second line 106 extends between the apparatus 10 and the delivery site 100. The second line 106 is coupled to the device 10 at a free end. When the pump-side component 12 and the patient-side component 14 are coupled, one or more valves within the apparatus 10 open to allow fluids, gases, and/or solids to travel through the apparatus 10 between the first line 104 and the second line 106. In the event that the patient 102 moves in a manner that exerts a threshold pull force on the first and

second lines

104, 106, the apparatus 10 may be disconnected such that the pump-side component 12 is disengaged from the patient-side component 14, as depicted in fig. 2. One or more valves in apparatus 10 may close immediately after pump-side component 12 is disengaged from patient-side component 14, such that a flow of fluid, gas, or solids is prevented from exiting each of pump-side component 12 and patient-side component 14.

In some embodiments, the apparatus 10 is designed such that the degree of pulling force required to disengage the pump-side component 12 and the patient-side component 14 is low enough to disengage the apparatus 10 before the delivery site 100 is inadvertently removed from the patient 102.

Referring to fig. 3, in some embodiments, the apparatus 10 includes a pump-side component 12 and a patient-side component 14 positioned axially opposite the pump-side component 12. In some embodiments, the pump-side part 12 comprises a first joint 13. The first connector 13 may comprise any suitable tube or hose connector configured to engage a corresponding free end of a medical tube. For example, in some embodiments, the first fitting 13 may include a hose barb fitting, a female luer fitting, a male luer fitting, an externally threaded fitting, an internally threaded fitting, or any other suitable fitting. Similarly, in some embodiments, the patient-side component 14 includes a second joint 15. The second connector 15 may be any suitable tube or hose connector configured to engage a corresponding free end of a medical tube. For example, in some embodiments, the second fitting 15 may comprise a hose barb fitting, a female luer fitting, a male luer fitting, an externally threaded fitting, an internally threaded fitting, or any other suitable fitting.

While a variety of forms, embodiments, and implementations are possible, in this application, this particular embodiment as depicted in fig. 3 will be discussed in detail while other embodiments will be described, including the combination of sub-portions into a single portion and the differences in particular implementations of the apparatus. The device 10 may be inserted onto an existing medical line. One end may be particularly suitable for coupling directly to a medical line. Other embodiments may provide alternative connections for medical lines such as luer locks and other similar adaptors. One end of the device 10 may be pre-installed on a portion of a medical line. This allows the second medical line (typically the patient end of the medical line having the delivery site 100 into the patient 102) to be coupled directly to the patient-side component 14 of the apparatus 10 via an adaptor, luer lock, or to be quickly decoupled. However, the device 10 may be configured to couple to multiple existing lines because typically these lines are currently configured with luer locks on the ends of medical lines.

Fig. 4 presents an exemplary embodiment of the apparatus 10, wherein the pump-side component 12 and the patient-side component 14 are coupled together such that fluids, gases, or solids may pass through the apparatus 10 for delivery to the patient 102 at the delivery site 100. For example, medical personnel may administer saline solution to the patient 102 through a medical line. The first line 104 may be coupled to the first junction 13 of the pump-side component 12. The saline solution will then enter the apparatus 10 at the flow inlet 16. In one embodiment, a channel 26 disposed about the axis 24 extends through the pump-side and patient-

side components

12, 14 when the pump-side and patient-

side components

12, 14 are coupled together. The saline solution flows through the pump-side part 12 to the patient-side part 14 via the channel 26. The second line 106 may be coupled to the second joint 15 of the patient-side part 14. The saline solution will then flow out of the patient side piece 14 and the apparatus 10 via the flow outlet 18 into the second line 106, which second line 106 then delivers the saline solution to the patient 102 via the delivery site 100.

In some embodiments, the apparatus 10 includes at least one valve to prevent fluid, gas, or solid flow when the pump-side component 12 is decoupled from the patient-side component 14. In one embodiment, the first valve 20 is disposed within the pump side component 12. The first valve 20 may comprise an active valve. The active valve 20 is configured to allow fluid to pass through the active valve 20 when the pump-side component 12 is coupled with the patient-side component 14. Thus, when the pump-side member 12 is coupled with the patient-side member 14, the active valve 20 is activated and fluid may pass through the pump-side member 12, and when the pump-side member 12 is decoupled from the patient-side member 14, the active valve 20 is not activated and fluid may not pass through the pump-side member 12. This prevents fluid loss in the event of a disconnection, either accidental or purposeful. Those skilled in the art will readily appreciate that various active valves, including QOSNA, may be implemented in such embodiments ^TM A check valve.

The second valve may be disposed within the patient-side component 14. Second valve 22 may comprise a passive valve. The passive valve 22 may be configured to allow flow in one direction. The passive valve 22 may also be described as a one-way valve. As fluid is pushed through the apparatus 10 from the pump-side component 12 to the patient-side component 14, the fluid is able to flow freely through the passive valve 22. However, if fluid is forced through the device 10 in a direction opposite to that previously described to some extent, fluid is unable to pass through the passive valve 22 in the opposite direction. This prevents fluid loss in the event of a disconnection, either accidental or purposeful. This also prevents backflow of fluid from the patient 102 to the pump-side component 12 and the first line 104. Reflux of fluid from the patient 102 may occur occasionally, including situations where the IV delivery bag has been emptied and a small portion of blood and other fluids (due to forces exerted by pressure gradients or diffusion) are carried away from the patient 102. The fluid traveling from the patient into the first line 104 and the second line 106 contaminates the

lines

104, 106 such that the lines need to be replaced. With the passive valve 22 or one-way valve disposed in the patient side component 14, fluid is unable to move in the reverse direction and contaminate the pump side component 12 and the first line 104. Those skilled in the art will readily appreciate that various one-way or passive valves, including duckbill valves, may be implemented in such embodiments.

Fig. 5 shows an exemplary embodiment in which the first valve 20 is arranged in the pump-side part 12 of the device 10. Fig. 6 shows an exemplary embodiment in which the second valve 22 is arranged in the patient-side part 14 of the apparatus 10.

Fig. 7 provides an image of an exemplary first valve 20 disposed in a first valve chamber 21 of the pump side component 12 of the apparatus 10. In this embodiment, the first valve 20 is an active valve. The first valve 20 includes a piston 28, a support base 29, and a diaphragm 30. When the first valve 20 is not activated, the diaphragm 30 forms a seal portion together with the inner wall 31 of the pump-side part 12 so that fluid cannot pass through the pump-side part 12. The piston 28 may be manually biased toward the diaphragm 30 such that the diaphragm 30 is biased away from the inner wall 31 and breaks the seal between the diaphragm 30 and the inner wall 31. With the diaphragm 30 biased away from the inner wall 31, fluid is able to flow past the diaphragm 30, past the piston 29, and past the pump side member 12. The diaphragm 30 can rest on a support base 29 within the first valve chamber 21. Support base 29 can be configured to permit fluid to pass from flow inlet 16 into first valve chamber 21. The support base 29 may also be configured to bias the diaphragm 30 toward the inner wall 31 of the pump-side member 12 when the piston 28 does not apply a force to the diaphragm 30, thus forming a seal between the diaphragm 30 and the inner wall 31. The sealing portion between the diaphragm 30 and the inner wall 31 can also be formed by forcing fluid from the pump into the pump-side part 12 and pressing the diaphragm 30 against the inner wall 31. The sealing portion may be formed by the two forces previously discussed.

Referring now to fig. 8, an exemplary embodiment of a patient-side component 14 disposed about an axis 24 is depicted. Patient-side component 14 further includes a guide or cannula 32, a second valve chamber 23, a flow outlet 18, and a passageway 26 extending through patient-side component 14. Second valve 22 may be disposed in second valve chamber 23. Second valve 22 may be a one-way valve, or more specifically, a duckbill valve, permitting fluid to travel in a single direction through second valve 22. In one embodiment, the cannula 32 extends from the second valve chamber 23, and the flow outlet is disposed at or near the second valve chamber 23 relative to the cannula 32. In this embodiment, fluid may enter cannula 32 and travel through passage 26 to second valve chamber 23. The second valve 22 disposed in the second valve chamber 23 is configured to permit fluid flow from the spigot portion of the passage 26 to the flow outlet portion of the passage 26. The fluid is then transferred out of the patient side member 14 of the apparatus 10. Fluid displaced from the cannula portion of the passageway 26 creates internal pressure on the duckbill valve, thereby opening the valve. External pressure on the duckbill valve causes the valve to seal closed as fluid travels in the opposite direction (from the flow outlet portion of the passageway 26).

Fig. 9 and 10 present embodiments in which various components are coupled together to form a pump-side component 12 and a patient-side component 14. In some embodiments, the pump-side piece 12 may include a female luer lock adapter 160, a luer-activated check valve housing 150, and a snap-fit connection 140. In some embodiments, the female luer lock 160, luer-activated check valve housing 150, and snap-fit connection 140 may be integrated into a single unit. The patient-side component 14 includes a reconnection prevention means 120 and a keyway means 130. In some embodiments, the anti-reattachment means 120 and the keyway means 130 may be integrated into a single unit. Each of these elements and various embodiments will be discussed in more detail below.

In one embodiment, the insertion tube 32 of the patient-side component 14 extends from the patient-side component 14. A channel 26b disposed about the axis 24 may extend through the cannula 32 and the patient-side member 14. When the cannula 32 is inserted into the pump side part 12, the channel 26a of the pump side part 12 is in a sealed configuration together with the channel 26b of the patient side part 14. Where the pump-side and patient-

side components

12, 14 include the various elements previously listed as depicted in fig. 11, each element has a separate channel 26a through 26e, which separate channels 26a through 26e form a single channel 26 through which fluid may flow through the device 10 when each of the elements are coupled together in a sealed configuration. The various components may be kept separate or they may be manufactured in various combinations of integral components other than the snap-fit connection 140 and the anti-reattachment means 120.

Fig. 12 shows an embodiment of the anti-reconnect device 120. The anti-reattachment device 120 includes a neck member 121 and a guide rod or cannula 32. The channel 26 passes through both the neck member 121 and the cannula 32. The channel 26 and the anti-reattachment means 120 may be disposed about the axis 24. In one embodiment, neck member 121 defines a second valve chamber 23, and a second valve 22 may be placed in second valve chamber 23 to control the flow rate and direction of liquid through apparatus 10. Many different valves may be placed in the chamber, but one embodiment includes a duckbill valve to control the direction of flow of liquid in the device 10.

The anti-reattachment device 120 may further include at least one securing arm 122. The securing arm 122 is configured to allow the device 10 to be removably coupled, thus allowing the medical line to be released when a force is applied to the medical line at both ends of the device 10. In some embodiments, a securing arm 122 extends from the anti-reattachment device 120 at the distal end of the neck piece 121. A securing arm 122 extends from the neck member 121 such that the securing arm 122 is located radially outward from the cannula 32. In some embodiments, securing arm 122 may be substantially perpendicular to axis 24. At the distal end of securing arm 122, securing interface 123 defines a curved portion where securing arm 122 is no longer parallel to axis 24 and begins to extend radially outward from axis 24 at an angle greater than 90 degrees. Accordingly, the clamping surface 124 extending from the securing arm 122 at the securing interface 123 is at an angle 125 of less than 90 degrees relative to a radial axis 126 extending perpendicularly from the first axis 24 extending through the channel 26. See fig. 17e and 18 d.

Another embodiment of the anti-reconnect device 120 may include a shield 127. The shield 127 may be disposed radially outward from the clamping surface 124 and, in other embodiments, about the securing arm 122. The shield 127 prevents a patient or other object from intentionally or inadvertently contacting the securing arm 122. In some embodiments, the shield 127 defines a fixed arm protector receiving slot 128. The fixed arm protector receiving slot 128 is configured to receive a fixed arm guard 136, which fixed arm guard 136 will be described further below.

Fig. 13 shows an embodiment of a keyway arrangement 130. The keyway arrangement 130 substantially corresponds to the anti-reattachment arrangement 120 to form the patient-side component 14. In one embodiment, the keyway device 130 can include a male luer lock 132 having a chamber wall 134 extending from a distal end of the male luer lock 132, the chamber wall 134 defining the second valve chamber 23. In some embodiments, the second valve chamber 23 of the anti-reconnect device 120 and the second valve chamber 23 of the keyway device 130 are the same chamber. The walls of each of the anti-reattachment means 120 and the keyway means 130 may correspond in such a way that they form a single second valve chamber 23, as revealed in fig. 14. A second valve 22 can be inserted into the second valve chamber 23 to regulate the flow rate and direction of fluid flow in the apparatus 10.

The keyway arrangement 130 is disposed about an axis 24 (which corresponds to the axis 24 about which the anti-reattachment arrangement 120 is disposed) such that, when the keyway arrangement 130 is coupled with the anti-reattachment arrangement 120, there is a single axis 24 about which the patient-side component 14 is disposed. The passage 26 extends through the keyway arrangement 130.

In some embodiments, keyway device 130 further includes a fixed arm guard 136. The fixed arm guard 136 is disposed radially outward from the fixed arm 122 of the anti-reattachment device 120 when coupled to the keyway device 130 (as presented in fig. 14). The fixed arm guard 136 acts as a shield to prevent access to the fixed arm 122. The fixed arm guard 136 may further define a keyhole 138. At times when the medical line is disconnected, the patient or another individual may attempt to reestablish the connection of the device 10. However, as the line may have been contaminated during the disconnection, re-establishing the connection may be dangerous for the patient. Thus, when the connection is established, the fixed arm 122 is inaccessible because the fixed arm guard 136 and the shield 127 prevent direct access to the fixed arm 122. The fixed arm 122 may be accessible only via the keyhole 138, which keyhole 138 may be disposed on the fixed arm protector 136 or the shield 127. The key hole 138 may be configured such that the only way to access the securing arm 122 is to use a specific tool designed for the key hole 138. This limits the ability to establish a connection between the pump-side part 12 and the patient-side part 14, and ultimately the ability to establish a connection between the IV and the patient 102. Thus, in the event of an accidental disconnection, the medical professional can correctly assess the situation to determine whether it is necessary to provide a new connection due to contamination.

Fig. 14 presents an exemplary embodiment of the patient-side piece 14. The patient side member 14 may be manufactured as three separate sub-parts (duckbill valve 22, anti-reconnect means 120 and keyway means 130). The sub-portions may be assembled and coupled using common techniques such as adhesive materials, connectors, and the like. Another embodiment may be implemented as an integral construction of a subpart. This may include 3-D printing techniques. However, it should be understood that the concepts disclosed herein do not depend upon whether the patient side member 14 is an assembled sub-portion or an integral unitary member.

To further understand the apparatus 10, the pump-side component 12 will now be described in more detail. The pump-side part 12 provides attachment points to which the securing arm 122 of the patient-side part 14 can be coupled, so that the pump-side part 12 and the patient-side part 14 are coupled to form the apparatus 10.

Fig. 15 discloses an exemplary embodiment of the pump-side part 12. In some embodiments, the pump-side component 12 may include a female luer lock 160, a luer-activated check valve device 150, and a snap-fit connection 140. Depending on the line used, the pump-side part 12 may comprise different sub-parts, such as a quick-coupling, a male luer lock, a bayonet coupling, a compression fitting, a barb coupling, a flare coupling, switchable valves, etc. In another embodiment, the pump-side part 12 may be a unitary whole and all components and functions disclosed by the female luer lock 160, the luer-activated check valve arrangement 150 and the snap-fit connection 140 may be integrated into a single unit.

Fig. 16 depicts an exemplary embodiment of a snap-fit connection 140. The snap-fit connection 140 may be disposed about the axis 24. The axis 24 may extend through all of the various sub-portions of the pump-side component 12 when coupled and aligned with the axis 24 of the patient-side component 14 and when the pump-side component 12 is removably coupled with the patient-side component 14. Further, the channel 26 may be disposed within the snap-fit connection 140. When the channel 26 is detachably coupled with the patient-side member 14, the

members

12, 14 form a single channel 26.

The snap-fit connection 140 may also define a loop-engaging portion recess 142. This recess 142 is configured to receive an annular land 144 to prevent fluid from escaping when the

components

12, 14 are removably coupled.

Exemplary embodiments of the snap-fit connection 140 may further include a securing lever 146. The securing lever 146 is configured to receive the securing arm 122 of the anti-reattachment device 120. In one embodiment, the relationship between the securing arm 122 and the securing lever 146 provides the device 10 with a re-attachment prevention function and a detachment function.

In some exemplary embodiments, the securing lever 146 may further include an inclined receiving surface 148. The inclined receiving surface 148 may be at an angle 149 of less than 90 degrees relative to the radial axis 126 extending perpendicularly from the first axis 24. See fig. 17e and 18 d. The angled receiving surface 148 of the securing lever 146 and the clamping surface 124 of the securing arm 122 are configured to complement each other. In some embodiments, this may result in the inclined receiving surface 148 and the clamping surface 124 being flush when the pump-side component 12 is removably coupled with the patient-side component 14. Thus, the clamping surface 124 and the inclined receiving surface 148 are in substantial contact when the pump-side part 12 is detachably coupled with the patient-side part 14. In other embodiments, surfaces 124, 148 are substantially parallel, but not completely parallel, and thus are not able to maintain a perfectly flush contact surface. In some embodiments, the securing arms 122 are biased slightly radially inward with the securing rods 146 when the pump-side component 12 is removably coupled with the patient-side component 14. This means that the securing arms 122 are biased radially outward, as the material prefers to remain in an unbiased state. In other embodiments, the securing lever 146 is positioned as follows: when the

members

12, 14 are removably coupled, the securing arms 122 contact the securing levers 146 but the securing arms 122 are not biased radially inward.

Fig. 17a to 17f and fig. 18a to 18e show the process of detaching the pump-side part 12 from the patient-side part 14 and coupling the pump-side part 12 with the patient-side part 14. In order to disengage the pump-side part 12 from the patient-side part 14, the securing arm 155 must pass through or clear the securing rod 146.

As previously mentioned, sometimes a patient or other environment may accidentally apply a force to the IV tubing. This can lead to deviation of the delivery site 100 of the patient 102, potentially causing extensive damage and severe pain to the tissue of the patient 102. In some embodiments, the complementary nature of the angled receiving surface 148 of the securing lever 146 and the clamping surface 124 of the securing arm 122 may provide for detachability of the pump-side component 12 from the patient-side component 14. When an outwardly opposing axial force 170 is applied across the device 10 (e.g., pulling an IV tube), the inclined receiving surface 148 applies a force 172 perpendicular to the plane of the inclined receiving surface 148 to the gripping surface 124 in response to the outwardly opposing axial force 170 applied across the device 10, since the inclined receiving surface 148 and the gripping surface 124 are not parallel or perpendicular to the radial axis 126. This force 172 is transmitted to the fixed arm 122. Due to the outwardly facing axial force 170 applied at both ends of the device 10, the securing arms 122 will then be biased radially inward in response to the force 172 applied by the angled receiving surfaces 148. See fig. 17b and 18 b. When the securing arms 122 are biased radially inward, the material of the securing arms 122 has some elasticity and exerts a radially outward directed force 174 to return the securing arms 122 to their resting position. After the

parts

12, 14 have been disengaged, the securing arm 122 will snap back into an unbiased position, as shown in fig. 18 e.

The outward relative axial force 170 required to effect disengagement of the pump-side and patient-

side components

12, 14 can be varied by changing several features of the apparatus 10. First, the seating angles 125, 149 of the inclined receiving surface 148 and the clamping surface 124 result in different degrees of resistance to disengagement. See fig. 18 d. For example, if the angled receiving surface 148 and the clamping surface 124 are set at an angle of approximately 90 degrees relative to the radial axis 126, the resulting force 172 is more complementary to the biasing direction of the securing arm 122 for disengagement, and will result in a radially inward force being applied to the securing arm 122 and will not result in an axial force on the securing arm 122. The radially inward force will bias the securing arms 122 radially inward. The axial force will result in tension on the securing arm 122 but will not bias the securing arm 122. Alternatively, the tension will provide resistance to the outward relative axial force 170. Thus, the closer the inclined receiving surface 148 and the clamping surface 124 are to being parallel relative to the radial axis 126, the more force between the two

assemblies

124 and 148 will be directed axially rather than radially. Accordingly, a greater outward relative axial force 170 is required to bias the securing arms 122 radially inward. See fig. 17 e.

Second, the outward relative axial force 170 required to achieve disengagement may vary depending on the length of the gripping surface 124. If the clamping surface 124 is longer, the securing arms 122 must be biased radially inward a greater distance to clear the angled receiving surface 148 and the securing lever 146. A greater force is required to bias the securing arms 122 radially inward so that the length of the gripping surface 124 can be increased or decreased if a greater or lesser outward relative axial force 170 is required to disengage. This may create certain material stresses on the securing arm 122, and thus the securing arm 122 may also include a reinforced joint 122a in which the securing arm 122 extends from the anti-reattachment device 120.

Third, the texture of the angled receiving surface 148 and the clamping surface 124 may be altered to provide more resistance. Upon application of an outward relative axial force 170 to the apparatus 10, the clamping surface 124 slides relative to the inclined receiving surface 148. The sliding action generates relative friction. The greater the coefficient of friction on both

surfaces

124, 148, the greater the outward relative axial force 170 required to disengage the apparatus 10. The surface area of the two

surfaces

124, 148 may be adjusted to provide different degrees of resistance. This includes larger or smaller surfaces 124, surfaces 148, or incomplete contact between both

surfaces

124 and 148.

Fourth, the material and thickness of the securing arm 122 may also alter the amount of outward relative axial force 170 necessary to disengage the device 10. When the securing arm 122 comprises a thicker and more rigid material, a greater force is required to radially bias the securing arm 122. Thus, the force necessary to decouple the two

components

12, 14 may be modified to maximize the effect of the device 10. For certain patients or insertion points, it may be necessary to use a low threshold tension or outward relative axial force 170 to cause detachment, as the tissue or patient may be particularly susceptible to damage or have particular sensitivity. Other situations may require a higher threshold to decouple. The loop engaging portion 144 may also provide additional resistance to decoupling of the two

components

12, 14.

The relationship between the fixed arm 122 and the fixed rod 146 and the fixed arm guard 136 provides the anti-reattachment feature of the present disclosure. The securing arm 122 further defines a deflection surface 129. When the pump-side component 12 and the patient-side component 14 are not coupled and the respective axes are aligned, the securing arm 122 is aligned with the securing rod 146 such that the deflection surface 129 of the securing arm 122 contacts the securing rod 146 when the two

components

12, 14 translate toward each other on the axis 24. The deflection surface 129 prevents further movement and the two

members

12, 14 cannot be coupled. In some embodiments, the deflection surface 129 is angularly disposed substantially parallel to the clamping surface 124. The securing lever 146 may also be placed at an angle or rounded such that when a user applies an inwardly facing relative axial force 171 to the two

components

12, 14 and the securing lever 146 is in contact with the deflection surface 129, the securing arm 122 will be biased radially outward, thus preventing the two

components

12, 14 from coupling.

Because the deflection surface 129 is aligned with the fixed rod 146 to prevent coupling when the securing arm 122 is unbiased, to achieve coupling of the two

members

12, 14, a user must manually bias the securing arm 122 radially inward so that the securing arm 122 moves away from and slides beyond the fixed rod 146 as the two

members

12, 14 translate toward one another along the axis 24. In some embodiments, the fixed arm guard 136 prevents access to the fixed arm 122. Accessible only through the key holes 138. A special wedge is required to bias the securing arms 122 radially inward. This allows the medical care provider to limit the ability to couple the two

components

12, 14 to the component to which the cleat has been attached. When inadvertent decoupling occurs, the medical care provider can evaluate the situation and determine whether the line can be reconnected or whether a new line needs to be used because the line is contaminated or damaged.

Those skilled in the art will readily recognize that the previously described components may be disposed on either of the

components

12, 14, and may be repositioned or inverted onto each of the

components

12, 14. Accordingly, it is within the scope of the present disclosure for the stationary arm 122, the stationary arm guard 146, and any other parts located on the patient-side component 14 as recited in the present disclosure to be relocated to the pump-side component 12, and for the stationary rod 146 and other accompanying elements located on the pump-side component 12 to be relocated to the patient-side component 14. Further, the valve 20, valve 22, and activation structure (cannula 32 and activation surface 32) may reside on the opposing component 12, component 14 as previously described when fluid is withdrawn from the patient 102 rather than administered to the patient 102.

In some embodiments, the two

components

12, 14 may also include closed end caps. The closed end cap is configured to prevent contamination of the internal passages and components of the

components

12, 14. In some embodiments, the closure cap may include existing components, such as the shield 127, the securing lever 146, and the securing arm guard 136. In other embodiments, the second end of the patient-side component 14 is operable to act as a first closed-end cap, and the proximal end of the pump-side component 12 is operable to act as a second closed-end cap. In other embodiments, the diameters of the channel 26 and the cannula 32 provide protection against tampering with the

valves

20, 22 of the device 10. After an accidental disconnection, the patient may attempt to reconnect the device 10, and the diameter of the passageway 26 and cannula 32 prevents contact with the

valves

20, 22, which could cause damage to the

valves

20, 22 and loss of fluid due to valve damage.

Since the apparatus 10 is used in fluid delivery applications, if a disconnection does occur, it is critical to stop fluid flow through the device to prevent loss of fluid from the patient and to prevent fluid from leaking out of, for example, an IV bag. Some embodiments may implement a series of valves to prevent fluid loss and cleaning and hazards due to non-contained fluids. As previously discussed, a duckbill valve 22 may be implemented in the apparatus 10 to prevent backflow of liquid in a direction opposite to the desired flow. A duckbill valve 22 is positioned within the downstream portions of the two

components

12, 14. Other one-way valves as well as multi-way valves may be implemented in various other embodiments. Thus, in the event that the patient expels fluid, the duckbill valve 22 will be in the pump side component 12 downstream of the patient 102, whereas in the event that fluid is administered to the patient 102, the duckbill valve 22 will be in proximity to the patient 102.

As previously discussed, the first valve 20 is needed to prevent fluid from continuing to flow from the source when the two

components

12, 14 have been disengaged. In some embodiments, this is accomplished by providing a first valve 20 that is active only when the two

components

12, 14 are coupled together. This may be accomplished by providing a cannula 32 extending into the pump side member 12 and activating the check valve or first valve 20. The pressure provided by the valve activation surface 34 of the cannula 32 activates the first valve 20 when the two

components

12, 14 are coupled. Upon separation of the two

components

12, 14, the valve activation surface 34 no longer applies pressure to the first valve 20, thus preventing fluid flow through the first valve 20. Some embodiments may utilize commercially available check valves, such as QOSNA ^TM The luer activates the check valve.

In some embodiments, the annulus joint 144 may be placed within the device 10 to minimize fluid loss during decoupling. When the two

components

12, 14 are separated from one another, the valve activation surface 34 of the cannula 32 is not in contact with the first valve 20. The annular surface interface 144 is positioned in the channel 26 such that the sealing portion around the cannula 32 remains intact even after the first valve 20 is not active. Thus, the system is still sealed even for a period of time after the first valve 20 is no longer active and fluid is unable to enter the apparatus 10 or pass through the apparatus 10. See fig. 17e and 17 f.

Thus, while particular embodiments of the present invention of a novel and useful split MEDICAL TUBING CONNECTOR (BREAKAWAY MEDICAL TUBING CONNECTOR) have been described herein, it is not intended that such references be construed as limitations upon the scope of this invention.

Claims

1. A medical tube connector apparatus comprising:

a pump-side component comprising:

a pump-side component housing having a first end and a second end;

a first passage disposed within the pump-side component housing;

an inlet disposed at the first end of the pump-side component housing and in fluid communication with the first channel;

a first valve disposed within the first passage downstream of the inlet; and

a fixing rod coupled to the second end of the pump-side component housing;

a patient-side component, comprising:

a patient-side component housing having a proximal end and a distal end;

a second channel disposed within the patient-side component housing;

an outlet disposed at the distal end of the patient side component housing and in fluid communication with the second channel;

a second valve disposed within the second passage upstream of the outlet; and

a stationary arm coupled to a proximal end of the pump-side component housing; and

a stationary arm protector extending from the patient-side member and positioned radially outward from the stationary arm,

wherein the pump-side component is configured to be removably coupled to the patient-side component via the fixation rod and the fixation arm;

wherein the stationary arm is configured to be biased radially inward when the pump-side component is decoupled from the patient-side component; and is

Wherein the fixed arm guard defines a keyhole configured to permit access to the fixed arm.

2. The medical tube connector apparatus of claim 1, wherein the fixation rod further defines a first surface of the fixation rod parallel to a first axis and a second surface of the fixation rod at a first angle of less than 90 degrees relative to a radial axis, wherein the radial axis is perpendicular to the first axis, thereby defining a fixed angle relative to the first surface of the fixation rod and the second surface of the fixation rod.

3. The medical tube connector apparatus according to claim 2, wherein said securement arm further defines a first surface of said securement arm and a second surface of said securement arm, wherein:

said first surface of said stationary arm is positioned at a second angle, complementary to said fixed angle, relative to said second surface of said stationary arm; and is

The second surface of the stationary arm contacts the second surface of the stationary rod when the patient-side member is detachably coupled with the pump-side member.

4. The medical tube connector apparatus according to claim 3, wherein the first angle and the fixed angle of the second surface of the fixation rod are configured to bias the fixation arm radially inward when the patient-side component is detachably coupled with the pump-side component, and an outward relative axial force is applied to the patient-side component and the pump-side component.

5. The medical tube connector apparatus according to claim 1, wherein said securing arm is positioned on said pump-side component such that when said patient-side component is decoupled from said pump-side component and an inwardly facing opposing axial force is applied to said patient-side component and said pump-side component, a distal end of said securing arm interferes with a distal portion of said securing rod, thereby preventing said patient-side component from being removably coupled with said pump-side component.

6. The medical tube connector apparatus according to claim 1, wherein the securing arms are configured to slide over the securing rod when manually biasing the securing arms radially inward.

7. A medical tube connector apparatus according to claim 1, wherein the first valve is an active valve.

8. The medical tube connector apparatus according to claim 7, wherein the first valve is activated upon application of an axial force to the first valve by a cannula.

9. The medical tube connector apparatus according to claim 1, wherein the second valve is a passive valve.

10. A medical tube connector apparatus according to claim 9, wherein the second valve is a duckbill valve.

11. A method of coupling a detachable line connector, comprising:

inserting a wedge through a key hole defined on a fixed arm guard, wherein the fixed arm guard extends from a first side component housing, wherein the first side component housing defines a second channel and has a cannula extending from the first side component housing;

contacting a securing arm with the wedge, wherein the securing arm is disposed on the first side member and positioned radially inward from the securing arm guard;

biasing said stationary arms radially inwardly with said wedge;

inserting the cannula of the first side member housing into a first channel of a second side member, wherein a fixation rod is disposed on the second side member, and wherein the fixation arm exits and passes through the fixation rod during insertion of the cannula; and

releasing the securing arms such that the securing arms are biased radially outward and engage the securing lever.

12. The method of coupling a removable line connector according to claim 11, further comprising activating a first valve disposed in the first channel by biasing the first valve axially outward from a distal end of the cannula.