Medical tube connector device and method for coupling detachable pipeline connector

Abstract

A medical tube connector device and a method for coupling a detachable pipeline connector are disclosed. A detachable medical tube connector device for joining two parts of a medical tube includes a pump side component and a patient side component positioned axially opposite to the pump side component. The pump side component has: a first channel disposed in the pump side component; and a first valve disposed in the first channel. The patient side component has: a second channel disposed in the patient side component; and a second valve disposed in the second channel. The first valve can be an active valve and the second valve can be a passive valve. In order to provide a detachable coupling of the two components, a fixing rod can be disposed on the pump side component and a fixing arm can be disposed on the patient side component.

Description

[0001] The present invention is a divisional application of the invention patent application with application number 201980019949.7 filed on January 17, 2019 and invention name “Medical tube connector device and method for coupling detachable pipeline connector”. Technical Field

[0002] The present disclosure generally relates to connectors for intravenous medical tubing. More specifically, the present disclosure relates to self-sealing breakaway intravenous line connectors. Background Art

[0003] In medical settings, medical tubes are often used to deliver fluids to or from a patient. Intravenous technology and techniques have developed to the point where the various devices associated with intravenous applications are sophisticated and often forgotten by the patient. As a result, it is not uncommon for patients to attempt to move limited by the medical tube and the devices connected to both ends of the tube. This often causes discomfort, pain, and even danger to the patient if the access point to the patient's vein is damaged. This can cause severe abrasions, lacerations, and even bleeding. This is particularly dangerous for the patient if the access point is a trunk vein, artery, or organ.

[0004] In the event that the access point is damaged by accidental movement, this can result in an unsanitary and dangerous environment as the patient may bleed and the fluid collected or introduced into the patient will pour out of 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 can pose a great risk to the patient, who is not trained to perform such a task. At the time of detachment, the line, insertion point, and fluid may have been contaminated, and if the patient is able to re-establish the line, the patient may introduce pathogens and other contamination directly into the body. This may result in serious and fatal infections and other serious complications.

[0005] There is thus a need for improved devices and methods for preventing accidental removal of intravenous insertion sites and discrete medical tube connections. Summary of the invention

[0006] 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.

[0007] One aspect of the present disclosure is a breakaway connector device placed between two medical tube devices. Typically in current medical practice, there is a device or tube inserted into the patient's body that, after exiting the patient's body, presents a device for connecting an outer segment of the tube. A secondary container for infused fluid or a container for draining fluid, sometimes with a pumping mechanism along the tube between the container and the patient. The connection point between these respective medical tube sections is of greatest importance because it provides an entry point for pathogens and is typically in close proximity to the patient and, therefore, near the insertion site.

[0008] The present disclosure allows for a sealed fluid connection between two connectors of a medical tube, but allows the tube portions to detach from each other upon application of a specific tension threshold or threshold range before the adhesive or fixation device fails, ultimately preventing the adverse event of premature removal of the device. The two ends of the device, which remain 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 to leak out of the patient or ultimately out of the container. The device can only be attached with a specific tool that is able to access the mechanism for attachment within the device.

[0009] Numerous other objects, advantages and features of the present disclosure will be readily apparent to those skilled in the art after reviewing the following drawings and description of the preferred embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 is a view of an embodiment of an exemplary device in use.

[0011] Figure 2 is a view of an embodiment of an exemplary device in use after separation.

[0012] Figure 3 is a perspective view of an embodiment of an exemplary apparatus.

[0013] Figure 4 is a cross-sectional side view of an embodiment of an exemplary apparatus.

[0014] Figure 5 is a front view of an exemplary pump side component having a first valve disposed in the pump side component.

[0015] Figure 6 is a front view of an exemplary patient-side component having a second valve disposed in the patient-side component.

[0016] Figure 7 is a cross-sectional side view of an exemplary embodiment of a first valve disposed in a pump-side component.

[0017] Figure 8 is a cross-sectional side view of an exemplary embodiment of a second valve disposed in a patient-side component.

[0018] Fig. 9 is a perspective view of an exemplary embodiment of a pump-side component and a patient-side component when decoupled.

[0019] Fig.10 is a cross-sectional perspective view of an exemplary embodiment of a pump-side component and a patient-side component when decoupled.

[0020] Fig.11 is an exploded perspective view of an exemplary embodiment of a device.

[0021] Fig.12 A cross-sectional side view of an exemplary embodiment of an anti-reconnection device.

[0022] Fig.13 is a cross-sectional perspective view of an exemplary embodiment of a keyway arrangement.

[0023] Fig.14 is a cross-sectional perspective view of an exemplary embodiment of a keyway device coupled with an anti-reconnection device.

[0024] Fig.15 is a cross-sectional side view of an exemplary embodiment of a pump side component.

[0025] Fig.16 is a cross-sectional perspective view of an exemplary embodiment of a snap-fit ​​connector.

[0026] Figure 17a to Figure 17f is a cross-sectional side view of an embodiment of a snap-fit ​​connection and an anti-reconnection device when an axial force is applied to the device.

[0027] Figures 18a to 18e A close up cross-sectional side view of an embodiment of a snap-fit ​​connection and an anti-reconnection device when an axial force is applied to the device. DETAILED DESCRIPTION

[0028] Although the making and use of various embodiments of the present invention are discussed in detail below, it should be understood that the present invention provides many applicable inventive concepts embodied in a wide variety of specific situations. The specific embodiments discussed herein are merely illustrative of specific ways to make and use the present invention, and do not limit the scope of the present invention. One of ordinary skill in the art will recognize numerous equivalents to the specific devices and methods described herein. Such equivalents are considered to be within the scope of the present invention and are covered by the claims.

[0029] In the drawings, for clarity, not all reference numerals are included in each drawing. In addition, positional terms such as "upper", "lower", "side", "top", "bottom", etc. refer to the device in the orientation depicted in the drawings or otherwise described. Those skilled in the art will recognize that the device can be in different orientations when in use.

[0030] Further reference to the diagram, Figure 1 An exemplary application of a patient-safe disconnect or breakaway medical tube connector device (device) 10 positioned on a medical line is shown. The device 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 device 10 includes a pump-side component 12 and a patient-side component 14. The device 10 is configured to decouple when a threshold amount of pulling force is applied in opposite axial directions along the device 10 so that the pump-side component 12 is separated from the patient-side component 14. Figure 1 As seen in the drawings, 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 device 10 and a source or sink of a fluid material, a gas material, or a 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 device 10 and the delivery site 100. The second line 106 is coupled to the device 10 at the free end. When the pump-side component 12 is coupled to the patient-side component 14, one or more valves within the device 10 open to allow fluid, gas, and / or solid to travel through the device 10 between the first line 104 and the second line 106. In the event that the patient 102 moves in a manner that applies a threshold pulling force to the first line 104 and the second line 106, the device 10 can be separated, such that the pump-side component 12 is disconnected from the patient-side component 14, as shown. Figure 2 One or more valves in the apparatus 10 may be closed immediately after the pump-side component 12 is disengaged from the patient-side component 14, so that flow of fluid, gas, or solids is prevented from leaving each of the pump-side component 12 and the patient-side component 14.

[0031] In some embodiments, the device 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 device 10 before the delivery site 100 is inadvertently removed from the patient 102 .

[0032] refer to Figure 3In some embodiments, the device 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 component 12 includes a first connector 13. The first connector 13 may include any suitable tube or hose connector configured to engage a corresponding free end of a medical tube. For example, in some embodiments, the first connector 13 may include a hose barb connector, a female Luer connector, a male Luer connector, an externally threaded connector, an internally threaded connector, or any other suitable connector. Similarly, in some embodiments, the patient-side component 14 includes a second connector 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 connector 15 may include a hose barb connector, a female Luer connector, a male Luer connector, an externally threaded connector, an internally threaded connector, or any other suitable connector.

[0033] Although various forms, embodiments and implementations are possible, in this application, the following will be discussed in detail. Figure 3 This particular embodiment illustrated in the accompanying description of other embodiments will also be described, including differences in combining sub-parts into a single part and specific implementations of the device. The device 10 can be inserted into an existing medical line. One end may be particularly suitable for direct coupling to a medical line. Other embodiments may provide alternative connections for medical lines such as Luer locks and other similar adapters. One end of the device 10 may be pre-installed on a portion of a medical line. This allows a second medical line (typically a patient end of a medical line having a delivery site 100 entering a patient 102) to be directly coupled to the patient side component 14 of the device 10 via an adapter, a Luer lock, or to be quickly disconnected. However, the device 10 may be configured to be coupled to multiple existing lines, because typically these lines are currently configured to have Luer locks on the ends of the medical lines.

[0034] Figure 4An exemplary embodiment of the device 10 is presented, wherein the pump-side component 12 and the patient-side component 14 are coupled together so that a fluid, gas, or solid can pass through the device 10 to be delivered to the patient 102 at the delivery site 100. For example, a medical professional can administer a saline solution to the patient 102 through a medical line. A first line 104 can be coupled to a first connector 13 of the pump-side component 12. The saline solution will then enter the device 10 at a flow inlet 16. In one embodiment, when the pump-side component 12 and the patient-side component 14 are coupled together, a channel 26 disposed about an axis 24 extends through the pump-side component 12 and the patient-side component 14. The saline solution flows through the pump-side component 12 to the patient-side component 14 via the channel 26. A second line 106 can be coupled to a second connector 15 of the patient-side component 14. The saline solution will then flow out of the patient-side component 14 and the device 10 via a flow outlet 18 into the second line 106, which then delivers the saline solution to the patient 102 via the delivery site 100.

[0035] In some embodiments, the device 10 includes at least one valve that is used to prevent the flow of fluid, gas or solid when the pump side component 12 is decoupled from the patient side component 14. In one embodiment, the first valve 20 is disposed in the pump side component 12. The first valve 20 may include 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 to the patient side component 14. Therefore, when the pump side component 12 is coupled to the patient side component 14, the active valve 20 is enabled and the fluid can pass through the pump side component 12, and when the pump side component 12 is decoupled from the patient side component 14, the active valve 20 is not enabled and the fluid may not pass through the pump side component 12. This prevents fluid loss from occurring in the event of a disconnection, whether accidental or purposeful. Those skilled in the art will readily appreciate that various active valves, including QOSINATM check valves, can be implemented in such embodiments.

[0036] The second valve may be disposed in the patient side component 14. The second valve 22 may include 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. When the fluid is pushed from the pump side component 12 through the device 10 to the patient side component 14, the fluid can flow freely through the passive valve 22. However, if the fluid is forced to pass through the device 10 in a direction opposite to the previously described direction to some extent, the fluid cannot pass through the passive valve 22 in the opposite direction. This prevents fluid loss from occurring in the event of a disconnection, whether accidental or purposeful. This also prevents fluid from flowing back from the patient 102 to the pump side component 12 and the first pipeline 104. Fluid backflow from the patient 102 may occur occasionally, including the situation where the IV delivery bag has been emptied and (due to the force applied by the pressure gradient or diffusion) a small portion of blood and other fluids are taken away from the patient 102. Fluid traveling from the patient to the first pipeline 104 and the second pipeline 106 contaminates the pipeline 104 and the pipeline 106, so that the pipeline needs to be replaced. With the passive valve 22 or one-way valve disposed in the patient side member 14, fluid cannot move in the reverse direction and contaminate the pump side member 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.

[0037] Figure 5 An exemplary embodiment is presented in which the first valve 20 is arranged in the pump-side part 12 of the device 10 . Figure 6 An exemplary embodiment is presented in which the second valve 22 is disposed in the patient-side component 14 of the apparatus 10 .

[0038] Figure 7An image of an exemplary first valve 20 disposed in a first valve chamber 21 of a pump side component 12 of an apparatus 10 is provided. 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 enabled, the diaphragm 30 forms a sealing portion with an inner wall 31 of the pump side component 12 so that fluid cannot pass through the pump side component 12. The piston 28 can be manually biased toward the diaphragm 30 so that the diaphragm 30 is biased away from the inner wall 31 and the sealing portion between the diaphragm 30 and the inner wall 31 is destroyed. When the diaphragm 30 is biased away from the inner wall 31, the fluid can flow through the diaphragm 30, through the piston 29, and through the pump side component 12. The diaphragm 30 can rest on the support base 29 in the first valve chamber 21. The support base 29 can be configured to allow fluid to pass from the flow inlet 16 into the 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, thereby forming a seal between the diaphragm 30 and the inner wall 31. The seal between the diaphragm 30 and the inner wall 31 may also be formed by forcing fluid from the pump into the pump side member 12 and pressing the diaphragm 30 against the inner wall 31. The seal may be formed by the two forces discussed previously.

[0039] Reference Figure 8 , depicting an exemplary embodiment of a patient-side component 14 disposed about an axis 24. The patient-side component 14 further includes a guide rod or cannula 32, a second valve chamber 23, a flow outlet 18, and a channel 26 extending through the patient-side component 14. The second valve 22 can be disposed in the second valve chamber 23. The second valve 22 can be a one-way valve, or more specifically, a duckbill valve, thereby permitting fluid to travel through the second valve 22 in a single direction. 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 can enter the cannula 32 and travel to the second valve chamber 23 through the channel 26. The second valve 22 disposed in the second valve chamber 23 is configured to permit fluid to flow from the cannula portion of the channel 26 to the flow outlet portion of the channel 26. The fluid is then transferred out of the patient-side component 14 of the device 10. The fluid moving from the cannula portion of the channel 26 creates an internal pressure on the duckbill valve, thereby opening the valve. When fluid travels in the opposite direction (from the flow outlet portion of passage 26), external pressure on the duckbill valve causes the valve to seal closed.

[0040] Fig. 9 and Fig.10Embodiments are presented 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 component 12 may include a female Luer lock adapter 160, a Luer-activated check valve housing 150, and a snap-fit ​​connector 140. In some embodiments, the female Luer lock 160, the Luer-activated check valve housing 150, and the snap-fit ​​connector 140 may be integrated into a single unit. The patient-side component 14 includes an anti-reconnection device 120 and a keyway device 130. In some embodiments, the anti-reconnection device 120 and the keyway device 130 may be integrated into a single unit. Each of these elements and various embodiments will be discussed in more detail below.

[0041] In one embodiment, the cannula 32 of the patient-side component 14 extends from the patient-side component 14. The channel 26b disposed about the axis 24 can extend through the cannula 32 and the patient-side component 14. When the cannula 32 is inserted into the pump-side component 12, the channel 26a of the pump-side component 12 is in a sealed configuration with the channel 26b of the patient-side component 14. Fig.11 1, each element has independent passages 26a-26e, which, when each of the elements is coupled together in a sealed configuration, form a single passage 26 through which fluid can flow through the device 10. The various components can remain separate, or the various components can be manufactured in various combinations of integral components other than the snap-fit ​​connector 140 and the anti-reconnection device 120.

[0042] Fig.12 An embodiment of an anti-reconnection device 120 is presented. The anti-reconnection device 120 includes a neck member 121 and a guide rod or cannula 32. The passage 26 passes through both the neck member 121 and the cannula 32. The passage 26 and the anti-reconnection device 120 can be arranged about the axis 24. In one embodiment, the neck member 121 defines a second valve chamber 23 in which a second valve 22 can be placed to control the flow rate and flow direction of liquid through the device 10. Many different valves can be placed in the chamber, but one embodiment includes a duckbill valve to control the flow direction of liquid in the device 10.

[0043] The anti-reconnection device 120 may further include at least one fixation arm 122. The fixation arm 122 is configured to allow the device 10 to be removably coupled, thereby allowing the medical lines at both ends of the device 10 to be released when a force is applied to them. In some embodiments, the fixation arm 122 extends from the anti-reconnection device 120 at the distal end of the neck member 121. The fixation arm 122 extends from the neck member 121 so that the fixation arm 122 is located radially outward from the cannula 32. In some embodiments, the fixation arm 122 may be substantially perpendicular to the axis 24. At the distal end of the fixation arm 122, the fixation joint 123 defines a bend where the fixation arm 122 is no longer parallel to the axis 24 and begins to extend radially outward from the axis 24 at an angle greater than 90 degrees. Therefore, the clamping surface 124 extending from the fixation arm 122 at the fixation joint 123 is at an angle 125 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 Fig.18d .

[0044] Another embodiment of the anti-reconnection device 120 can include a shield 127. The shield 127 can be disposed radially outward from the clamping surface 124, and in other embodiments is disposed around the fixed arm 122. The shield 127 prevents the patient or other objects from intentionally or unintentionally contacting the fixed arm 122. In some embodiments, the shield 127 defines a fixed arm guard receiving slot 128. The fixed arm guard receiving slot 128 is configured to receive a fixed arm guard 136, which will be further described below.

[0045] Fig.13 An embodiment of a keyway device 130 is presented. The keyway device 130 substantially corresponds to the anti-reconnection device 120 to form the patient-side component 14. In one embodiment, the keyway device 130 may 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-reconnection device 120 and the second valve chamber 23 of the keyway device 130 are the same chamber. The walls of each of the anti-reconnection device 120 and the keyway device 130 may correspond in such a manner that they form a single second valve chamber 23, such as Fig.14 The second valve 22 can be inserted into the second valve chamber 23 to adjust the flow rate and flow direction of the fluid in the device 10.

[0046] The keyway device 130 is disposed about an axis 24 (which corresponds to the axis 24 about which the anti-reconnection device 120 is disposed) such that there is a single axis 24 about which the patient-side component 14 is disposed when the keyway device 130 is coupled with the anti-reconnection device 120. A passage 26 extends through the keyway device 130.

[0047] In some embodiments, the keyway device 130 further includes a fixed arm guard 136. The fixed arm guard 136 is coupled to the keyway device 130 (e.g. Fig.14 127). 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. When a medical line is disconnected, sometimes a patient or another individual may attempt to reestablish a connection with the device 10. However, since the line may have been contaminated during the disconnection, reestablishing the connection may be dangerous for the patient. Therefore, when the connection is established, the fixed arm 122 cannot be accessed because the fixed arm guard 136 and the shield 127 prevent direct access to the fixed arm 122. The fixed arm 122 can only be accessed via the keyhole 138, which can be disposed on the fixed arm guard 136 or the shield 127. The keyhole 138 can be configured so that the only way to access the fixed arm 122 is to use a specific tool designed for the keyhole 138. This limits the ability to establish a connection between the pump-side component 12 and the patient-side component 14, and ultimately the ability to establish a connection between the IV and the patient 102. Thus, in the event of an unexpected disconnection, a medical professional can properly assess the situation to determine if it is necessary to provide a new connection due to contamination.

[0048] Fig.14 An exemplary embodiment of the patient side component 14 is presented. The patient side component 14 can be manufactured as three separate sub-parts (duckbill valve 22, anti-reconnection device 120, and keyway device 130). The sub-parts can be assembled and coupled using common techniques such as adhesive materials, connectors, etc. Another embodiment can be implemented as an integral construction of the sub-parts. This can include 3-D printing technology. However, it should be understood that the concepts disclosed herein do not depend on whether the patient side component 14 is a plurality of assembled sub-parts or an integral single component.

[0049] To further understand the device 10, the pump side component 12 will now be described in more detail. The pump side component 12 provides an attachment point to which the fixed arm 122 of the patient side component 14 can be coupled, so that the pump side component 12 and the patient side component 14 are coupled to form the device 10.

[0050] Fig.15Exemplary embodiments of the pump side component 12 are disclosed. 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 ​​connector 140. Depending on the tubing used, the pump side component 12 may include different sub-parts, such as a quick connector, a male Luer lock, a bayonet connector, a compression fitting, a barb connector, a flare connector, a switchable valve, etc. In another embodiment, the pump side component 12 may be a unified whole, and all components and functions disclosed by the female Luer lock 160, the Luer activated check valve device 150, and the snap-fit ​​connector 140 may be integrated into a single unit.

[0051] Fig.16 An exemplary embodiment of a snap-fit ​​connector 140 is depicted. The snap-fit ​​connector 140 can be disposed about the axis 24. 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, the axis 24 can extend through all of the various subsections of the pump-side component 12. In addition, the channel 26 can be disposed within the snap-fit ​​connector 140. When the channel 26 is removably coupled with the patient-side component 14, the components 12, 14 form a single channel 26.

[0052] The snap-fit ​​connector 140 may also define an annular surface engagement portion recess 142. This recess 142 is configured to receive the annular surface engagement portion 144 to prevent fluid from escaping when the components 12, 14 are removably coupled.

[0053] Exemplary embodiments of snap-fit ​​connector 140 may further include securing rod 146. Securement rod 146 is configured to receive securing arm 122 of anti-reconnection device 120. In one embodiment, the relationship between securing arm 122 and securing rod 146 provides device 10 with both anti-reconnection and detachment functions.

[0054] In some exemplary embodiments, the fixing rod 146 may further include an inclined receiving surface 148. The inclined receiving surface 148 may be at an angle 149 less than 90 degrees relative to the radial axis 126 extending perpendicularly from the first axis 24. Fig.17e and Fig.18d. The inclined receiving surface 148 of the fixing rod 146 and the clamping surface 124 of the fixing arm 122 are configured to complement each other. In some embodiments, this can cause the inclined receiving surface 148 and the clamping surface 124 to be flush when the pump-side component 12 is removably coupled to the patient-side component 14. Therefore, when the pump-side component 12 is removably coupled to the patient-side component 14, the clamping surface 124 and the inclined receiving surface 148 are substantially in contact. In other embodiments, the surfaces 124, 148 are substantially parallel, but not completely parallel, and therefore cannot maintain a perfect flush contact surface. In some embodiments, the fixing rod 146 is used to slightly bias the fixing arm 122 radially inward when the pump-side component 12 is removably coupled to the patient-side component 14. This means that the fixing arm 122 is biased radially outward because the material prefers to remain in an unbiased state. In other embodiments, the securing rod 146 is positioned in such a manner that the securing arms 122 and the securing rod 146 contact but the securing arms 122 are not biased radially inward when the components 12 , 14 are removably coupled.

[0055] Figure 17a to Figure 17f as well as Figures 18a to 18e The process of the pump side component 12 being detached from the patient side component 14 and the pump side component 12 being coupled to the patient side component 14 is shown. In order to detach the pump side component 12 from the patient side component 14, the fixing arm 155 must pass through or leave the fixing rod 146.

[0056] As previously mentioned, sometimes, the patient or other environment can accidentally apply force to the IV tube. This can cause deviation of the delivery site 100 of the patient 102, which may cause extensive damage to the tissue of the patient 102 and severe pain. In some embodiments, the complementary nature of the inclined receiving surface 148 of the fixed rod 146 and the clamping surface 124 of the fixed arm 122 can provide detachability of the pump side component 12 from the patient side component 14. When an outward relative axial force 170 is applied at both ends of the device 10 (for example, pulling the IV tube), since the inclined receiving surface 148 and the clamping surface 124 are not parallel or perpendicular to the radial axis 126, in response to the outward relative axial force 170 applied at both ends of the device 10, the inclined receiving surface 148 applies a force 172 perpendicular to the plane of the inclined receiving surface 148 to the clamping surface 124. This force 172 is transmitted to the fixed arm 122. Due to the outwardly directed relative axial forces 170 applied at both ends of the device 10, the securing arms 122 will then be biased radially inwardly in accordance with the forces 172 applied by the inclined receiving surfaces 148. Fig.17b and Fig.18b When the securing arm 122 is biased radially inward, the material of the securing arm 122 has some elasticity and exerts a radially outwardly directed force 174 to return the securing arm 122 to its rest position. After the components 12, 14 have been disengaged, the securing arm 122 will snap back into the unbiased position, as shown in FIG. Fig.18e As shown in .

[0057] The outward relative axial force 170 required to achieve disengagement of the pump-side component 12 and the patient-side component 14 can be varied by varying several features of the device 10. First, the angles 125, 149 of the placement of the inclined receiving surface 148 and the clamping surface 124 result in different degrees of resistance to disengagement. Fig.18d . For example, if the inclined receiving surface 148 and the clamping surface 124 are set to be at an angle close to 90 degrees relative to the radial axis 126, the resulting force 172 is more complementary to the bias direction of the fixed arm 122 for disengagement, and will result in a radially inward force applied to the fixed arm 122 and will not result in an axial force on the fixed arm 122. The radially inward force will cause the fixed arm 122 to bias radially inward. The axial force will cause tension on the fixed arm 122, but will not bias the fixed arm 122. Instead, the tension will provide resistance to the outward relative axial force 170. Therefore, the closer the inclined receiving surface 148 and the clamping surface 124 are to parallel relative to the radial axis 126, the more the force between the two components 124 and 148 will be directed axially rather than radially. Therefore, a larger outward relative axial force 170 is required to bias the fixed arm 122 radially inward. See. Fig.17e .

[0058] Second, the outward relative axial force 170 required to achieve disengagement may vary depending on the length of the clamping surface 124. If the clamping surface 124 is longer, then the securing arm 122 must be biased radially inward a greater distance to clear the inclined receiving surface 148 and the securing rod 146. A greater force is required to bias the securing arm 122 radially inward, and therefore, if a greater or lesser outward relative axial force 170 is required to achieve disengagement, then the length of the clamping surface 124 may be increased or decreased, respectively. This may produce certain material stresses on the securing arm 122, and therefore the securing arm 122 may also include a reinforced joint 122a in which the securing arm 122 extends from the anti-reconnection device 120.

[0059] Third, the texture of the inclined receiving surface 148 and the clamping surface 124 can be changed to provide more resistance. When the outward relative axial force 170 is applied to the device 10, the clamping surface 124 slides relative to the inclined receiving surface 148. The sliding action creates a relative friction force. The greater the coefficient of friction on the two surfaces 124, surface 148, the greater the outward relative axial force 170 required to disengage the device 10. The surface area of ​​the two surfaces 124, surface 148 can be adjusted to provide different degrees of resistance. This includes larger or smaller surfaces 124, surface 148, or incomplete contact between the two surfaces 124 and surface 148.

[0060] Fourth, the material and thickness of the fixation arm 122 can also change the amount of outward relative axial force 170 necessary to disengage the device 10. When the fixation arm 122 includes thicker and more rigid material, a greater force is required to radially bias the fixation arm 122. Therefore, the force necessary to decouple the two components 12, 14 can be modified to maximize the effectiveness 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 disengagement because the tissue or patient may be particularly vulnerable or have special sensitivity. Other situations may require a higher threshold to decouple. The annular joint 144 can also provide additional resistance to the decoupling of the two components 12, 14.

[0061] The relationship between the fixed arm 122 and the fixed rod 146 and the fixed arm guard 136 provides the anti-reconnection feature of the present disclosure. The fixed 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 corresponding axes are aligned, the fixed arm 122 is aligned with the fixed rod 146 so that when the two components 12, 14 are translated toward each other on the axis 24, the deflection surface 129 of the fixed arm 122 contacts the fixed rod 146. The deflection surface 129 prevents further movement, and the two components 12, 14 are not able to couple. In some embodiments, the deflection surface 129 is angularly positioned to be substantially parallel to the clamping surface 124. The securing rod 146 may also be angled or rounded so that when a user applies an inward relative axial force 171 to both components 12, 14 and the securing rod 146 contacts the deflection surface 129, the securing arms 122 will be biased radially outward, thereby preventing the two components 12, 14 from coupling.

[0062] Because the deflection surface 129 is aligned with the fixed rod 146 to prevent coupling when the fixed arm 122 is not biased, in order to achieve coupling of the two components 12, 14, the user must manually bias the fixed arm 122 radially inward so that when the two components 12, 14 are translated toward each other along the axis 24, the fixed arm 122 moves away and slides beyond the fixed rod 146. In some embodiments, the fixed arm guard 136 prevents the fixed arm 122 from being accessed. Access is only possible through the key hole 138. A specific wedge is required to bias the fixed arm 122 radially inward. This allows the medical care provider to limit the ability to couple the two components 12, 14 to the component that has the wedge inserted. When an unintentional decoupling occurs, the medical care provider can evaluate the situation and determine whether the pipeline can be reconnected or whether a new pipeline needs to be used because the pipeline is contaminated or damaged.

[0063] Those skilled in the art will readily recognize that the components previously described may be disposed on either of the components 12, 14 and may be relocated or inverted to each of the components 12, 14. Thus, it is within the scope of the present disclosure that the fixation arm 122, fixation arm guard 146, and any other portion located on the patient-side component 14 as described in the present disclosure be relocated to the pump-side component 12, and that the fixation rod 146 and other accompanying elements located on the pump-side component 12 be relocated to the patient-side component 14. Furthermore, when fluid is being drawn from the patient 102 rather than being administered to the patient 102, the valve 20, valve 22, and the activation structure (cannula 32 and activation surface 32) may reside on the opposing components 12, 14 as previously described.

[0064] In some embodiments, the two components 12 and 14 may also include a closed end cap. The closed end cap is configured to prevent contamination of the internal channels and components of the components 12 and 14. In some embodiments, the closed end cap may include existing components, such as a shield 127, a fixed rod 146, and a fixed arm guard 136. In other embodiments, the second end of the patient-side component 14 is operable to serve as a first closed end cap, and the proximal end of the pump-side component 12 is operable to serve as a second closed end cap. In other embodiments, the diameter of the channel 26 and the cannula 32 provides protection from tampering with the valves 20 and 22 of the device 10. After an accidental disconnection, the patient may attempt to reconnect the device 10, and the diameter of the channel 26 and the cannula 32 prevents contact with the valves 20 and 22, which may cause damage to the valves 20 and 22 and cause fluid loss due to damaged valves.

[0065] Since the device 10 is used for fluid delivery applications, if disconnection does occur, it is crucial to stop the fluid flowing through the device to prevent fluid loss in the patient and to prevent fluid leakage in, for example, an IV bag. Some embodiments may implement a series of valves to prevent fluid loss and the cleaning and danger caused by non-contained fluids. As previously discussed, a duckbill valve 22 may be implemented in the device 10 to prevent liquid from flowing back in a direction opposite to the desired flow. The duckbill valve 22 is placed in the downstream portion of the two components 12 and component 14. Other one-way valves and multi-way valves may also be implemented in various other embodiments. Therefore, when the patient discharges fluid, the duckbill valve 22 will be in the pump side component 12 downstream of the patient 102, but when the fluid is given to the patient 102, the duckbill valve 22 will be close to the patient 102.

[0066] As previously discussed, the first valve 20 is needed to prevent the fluid from continuing to flow out of the source when the two components 12, 14 have been disengaged. In some embodiments, this is achieved by providing a first valve 20 that is active only when the two components 12, 14 are coupled together. This can be achieved by providing a cannula 32 extending into the pump side component 12 and activating a check valve or the first valve 20. The pressure provided by the valve activation surface 34 of the cannula 32 when the two components 12, 14 are coupled activates the first valve 20. When the two components 12, 14 are separated, the valve activation surface 34 no longer applies pressure to the first valve 20, thereby preventing fluid from flowing through the first valve 20. Some embodiments can utilize commercially available check valves, such as QOSINATM Luer-activated check valves.

[0067] In some embodiments, an 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 each other, the valve activation surface 34 of the cannula 32 is not in contact with the first valve 20. The annulus joint 144 is disposed in the passage 26 so that the seal around the cannula 32 remains intact even after the first valve 20 is no longer active. Thus, the system remains sealed even for a period of time after the first valve 20 is no longer active and fluid cannot enter or pass through the device 10. See FIG. Fig.17e and Fig.17f .

[0068] Therefore, although specific embodiments of the present invention of a novel and useful BREAKAWAY MEDICALTUBING CONNECTOR have been described herein, it is not intended that these references be construed as limitations on the scope of the invention.

Claims

1. A connector device, comprising: a first side member including a first housing having an inner wall, a first passage disposed in the first housing, and a first valve disposed in the first passage, wherein the first valve is an active valve and wherein the first valve includes a first seal; a fixing rod coupled to the first housing; A second side member, comprising a second housing, a second passage disposed in the second housing, a second valve disposed in the second passage, and a cannula extending from the second side member to the first side member; a securing arm coupled to the second housing, wherein the securing arm engages the securing rod when the first side member is coupled to the second side member; and an annular joint between the cannula and the first side member, wherein the annular joint forms a second seal between the first side member and the second side member, The second seal of the annular joint remains engaged after the retaining rod and the retaining arm are disengaged when the first side member is decoupled from the second side member.

2. The connector apparatus of claim 1, wherein the annular joint provides resistance between the first side member and the second side member when the first side member and the second side member are decoupled.

3. The connector apparatus of claim 2, wherein the resistance provided by the annular surface engagement portion provides a first component of a separation force required to decouple the first side member from the second side member.

4. The connector apparatus of claim 3, wherein engagement of the securing rod with the securing arm provides a second component of the separation force required to decouple the first side member from the second side member.

5. The connector apparatus of claim 4, wherein when the first side member is decoupled from the second side member, the first seal closes before the second seal opens. The connector apparatus of claim 1 , wherein the annular engagement portion has a ring shape.

7. The connector apparatus of claim 1, wherein the annular joint includes a sealing member that surrounds the cannula when the first side member is coupled to the second side member.

8. The connector apparatus of claim 7, wherein when the first side member is decoupled from the second side member, the ones of the sealing members surrounding the cannula remain in contact with the cannula after the first valve is closed.

9. The connector apparatus of claim 1, wherein the annular interface comprises an O-ring on the first side member, wherein the cannula extends through the O-ring to form the second seal when the first side member is coupled to the second side member.

10. The connector apparatus of claim 9, wherein the o-ring remains in contact with the cannula after the first seal is closed when the first side member is decoupled from the second side member.

11. A method of using a detachable pipeline connector, comprising: providing a first side member, the first side member comprising a first housing having an inner wall, a first passage disposed in the first housing, and a first valve disposed in the first passage, wherein the first valve is an active valve and forms a first seal; providing a second side member, the second side member comprising a second housing, a second passage disposed in the second housing, a second valve disposed in the second passage, and a cannula extending from the second side member to the first side member; providing an annular joint between the cannula and the first side member, wherein the annular joint provides a second seal around the cannula; decoupling the first side member from the second side member; and The second seal of the annular interface is maintained in engagement after the first seal is closed when the first side member is decoupled from the second side member.

12. The method of claim 11, further comprising an annulus interface groove defined in the first side member, and a sealing member disposed in the annulus interface groove, wherein the cannula is received by the sealing member.

13. The method of claim 12, wherein the sealing member is an O-ring and the cannula extends through the O-ring.

14. The method of claim 11, wherein the annular joint provides resistance when the first side member is decoupled from the second side member.

15. The method of claim 14, wherein the resistance provided by the annular engagement provides a component of the axial separation force required to decouple the first side member from the second side member.

16. The method of claim 15, further comprising disengaging the second seal after the first seal is closed when the first side member is decoupled from the second side member.

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