CN115253060A - Medical tube connector equipment and method for coupling detachable pipeline connectors - Google Patents

Abstract

Disclosed are a medical tube connector device and a method for coupling a detachable pipeline connector. A split medical tubing connector apparatus for joining two portions of medical tubing includes a pump side member and a patient side member positioned axially opposite the pump side member. The pump-side member has: a first passage disposed within 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 member; and a second valve disposed within the second channel. The first valve may be an active valve and the second valve may be a passive valve. In order to provide a detachable coupling of the two parts, the fixing rod can be arranged on the pump-side part and the fixing arm can be arranged on the patient-side part.

Description

Medical tubing connector apparatus and method of coupling a detachable tubing connector

This invention is a divisional application of the invention patent application with the application number 201980019949.7 and the invention name "Medical Pipe Connector Equipment and Method for Coupling Detachable Pipeline Connectors" filed on January 17, 2019.

technical field

The present disclosure generally relates to connections for IV medical tubing. More specifically, the present disclosure relates to self-sealing breakaway IV line connections.

Background technique

In a medical environment, medical tubing is often used to deliver fluids to or from a patient. Intravenous technology and technology have evolved to such an extent that the various devices associated with intravenous applications are delicate and often forgotten by patients. Accordingly, it is not uncommon for patients to attempt movement restricted by the medical tubing and the devices attached to the ends of the medical tubing. This is often uncomfortable, painful and even dangerous for the patient if the access point to the patient's veins is damaged. This can cause severe bruising, tearing, and even bleeding. This is especially dangerous for the patient if the access point is a main vein, artery or organ.

When the access point is damaged by accidental movement, this can lead to an unsanitary and dangerous environment as the patient may bleed and fluid collected or introduced into the patient will pour out of the storage container. The patient may panic and try to re-establish the connection, which may be dangerous due to the risk of contamination of the line, which can be extremely dangerous to the patient, and the patient is not trained to perform this type of task . When detachment occurs, the line, insertion point, and fluid may have been contaminated, and if the patient is able to reestablish the line, the patient may introduce pathogens and other contamination 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 intravenous insertion sites and separate medical tubing connections.

Contents of the invention

This Summary is provided to introduce in simplified form a selection of concepts 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 device placed between two medical tubing devices. Often in current medical practice there is a device or tube inserted into the patient's body which, after exiting from the patient's body, presents a means for connecting the outer segments of the tube. A secondary container for infused fluid, or a container for draining fluid, sometimes has a pumping mechanism along the tubing between the container and the patient. The connection points between these respective medical tubing sections are of greatest importance since they provide entry points for pathogens and are 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 medical tubing, but allows the tube sections to disengage from each other upon application of a specific tension threshold or range of thresholds before the adhesive or securing device fails, ultimately preventing premature removal of the device. adverse event. The ends of the device, still attached to 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 escape from the patient or eventually from the container. The device may only be attached with certain tools that enable access to the mechanism for attachment within the device.

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 preferred embodiments.

Description of drawings

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

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

Figure 3 is a perspective view of an embodiment of an exemplary device.

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

5 is a front view of an exemplary pump side component with a first valve disposed in the pump side component.

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

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

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

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

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

Figure 11 is an exploded perspective view of an exemplary embodiment of a device.

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

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

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

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

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-reconnection device when an axial force is applied to the device.

Figures 18a-18e are close-up cross-sectional side views of an embodiment of a snap fit connection and anti-reconnection device upon application of an axial force to the device.

Detailed ways

While the making and using of various embodiments of the invention are discussed in detail below, it should be appreciated that the invention provides many applicable inventive concepts that can be embodied in a wide variety of specific situations. The specific embodiments discussed herein are merely illustrative of specific ways to make and use the invention, and do not limit the scope of the invention. Those 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 this invention and are covered by the claims.

In the drawings, not all reference numbers of figures are included in each drawing for the sake of clarity. Additionally, 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 may assume different orientations when in use.

With further reference to the drawings, FIG. 1 illustrates an exemplary application of a patient-safe disconnect or breakaway medical tubing connector device (device) 10 positioned on a medical line. Device 10 may be used in any suitable medical gas, fluid or solid delivery, withdrawal or monitoring line, such as an intravenous (IV) line. In some embodiments, apparatus 10 includes a pump-side component 12 and a patient-side component 14 . Device 10 is configured to decouple upon application of a threshold amount of pulling force in opposite axial directions along device 10 to separate pump-side component 12 from 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 device 10 and the delivery site 100 . A second line 106 is coupled to the apparatus 10 at a free end. When pump-side component 12 is coupled with patient-side component 14 , one or more valves within device 10 open to allow fluid, gas, and/or solids to travel through device 10 between first line 104 and second line 106 . With patient 102 moving in a manner that applies a threshold pull on first line 104 and second line 106 , device 10 may separate such that pump-side component 12 is disengaged from 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 the flow of fluid, gas, or solids is prevented from exiting each of pump-side component 12 and patient-side component 14 .

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

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

While many forms, embodiments and implementations are possible, in this application this particular embodiment as depicted in Figure 3 will be discussed in detail while other embodiments will be described, including combining sub-parts into a single part as well as differences in specific implementations of equipment. Device 10 is insertable into existing medical lines. 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 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 with the delivery site 100 into the patient 102) to be coupled directly to the patient side part 14 of the device 10 via an adapter, luer lock, or quickly decoupled. . However, device 10 may be configured to couple to a number of existing lines, since typically these lines are currently configured with a Luer lock on the end of the medical line.

FIG. 4 presents an exemplary embodiment of device 10 in which pump-side component 12 and patient-side component 14 are coupled together such that fluids, gases or solids may pass through device 10 for delivery to patient 102 at delivery site 100 . For example, medical personnel may administer saline solution to patient 102 through a medical line. The first line 104 can be coupled to the first connection 13 of the pump-side component 12 . The saline solution will then enter the apparatus 10 at the flow inlet 16 . In one embodiment, passage 26 disposed about axis 24 extends through pump side component 12 and patient side component 14 when pump side component 12 and patient side component 14 are coupled together. The saline solution flows through the pump side part 12 to the patient side part 14 via passage 26 . The second line 106 can be coupled to the second connection 15 of the patient-side component 14 . The saline solution will then flow out of the patient side part 14 and device 10 via the flow outlet 18 into the second line 106 which then delivers the saline solution to the patient 102 via the delivery site 100 .

In some embodiments, apparatus 10 includes at least one valve to prevent fluid, gas, or solid flow when pump-side component 12 is decoupled from 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. Active valve 20 is configured to allow fluid to pass through active valve 20 when pump-side component 12 is coupled to patient-side component 14 . Thus, when the pump-side component 12 is coupled to the patient-side component 14, the active valve 20 is activated and 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 activated. And the fluid may not pass through the pump side part 12 . This prevents fluid loss in the event of a disconnection, whether accidental or purposeful. Those skilled in the art will readily appreciate that various active valves, including QOSINA™ check valves, can be implemented in such embodiments.

The second valve may be positioned within the patient side component 14 . The second valve 22 may comprise a passive valve. Passive valve 22 may be configured to allow flow in one direction. Passive valve 22 may also be described as a one-way valve. Fluid is able to freely flow through the passive valve 22 as fluid is pushed from the pump side component 12 through the device 10 to the patient side component 14 . However, if the fluid is somehow forced through the device 10 in a direction opposite to that previously described, the fluid cannot pass through the passive valve 22 in the opposite direction. This prevents fluid loss in the event of a disconnection, whether accidental or purposeful. This also prevents backflow of fluid from the patient 102 into the pump side component 12 and the first line 104 . Backflow of fluid from the patient 102 can occur sporadically, including when the IV delivery bag has emptied and (due to forces exerted by pressure gradients or diffusion) a small portion of blood and other fluids are carried away from the patient 102 . 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 part 14 , fluid cannot move in the reverse direction and contaminate the pump side part 12 and the first line 104 . Those skilled in the art will readily appreciate that various one-way or passive valves, including duckbill valves, can be implemented in such embodiments.

FIG. 5 presents an exemplary embodiment in which the first valve 20 is arranged in the pump-side part 12 of the device 10 . FIG. 6 presents an exemplary embodiment in which the second valve 22 is disposed in the patient-side component 14 of the device 10 .

FIG. 7 provides an image of an exemplary first valve 20 disposed in the first valve chamber 21 of the pump side part 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 sealing 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 can be manually biased towards the diaphragm 30 such that the diaphragm 30 is biased away from the inner wall 31 and the seal between the diaphragm 30 and the inner wall 31 is broken. With the diaphragm 30 biased away from the inner wall 31 , fluid is able to flow through the diaphragm 30 , through the piston 29 and through the pump side component 12 . The diaphragm 30 may rest on the support base 29 within the first valve chamber 21 . The support base 29 may be configured to permit 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 towards the inner wall 31 of the pump side part 12 when the piston 28 is not exerting a force on the diaphragm 30 , thus 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 part 12 and pressing the diaphragm 30 against the inner wall 31 . The sealing portion can be formed by two forces previously discussed.

Referring now to FIG. 8 , an exemplary embodiment of patient side member 14 disposed about axis 24 is depicted. 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 accommodated in the second valve chamber 23 . The second valve 22 may be a one-way valve, or more specifically, a duckbill valve, 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 positioned at or near the second valve chamber 23 relative to the cannula 32 . In this embodiment, fluid may enter cannula 32 and travel through channel 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 cannula portion of the channel 26 to the flow outlet portion of the channel 26 . Fluid is then delivered from the patient-side component 14 of the device 10 . Fluid moving from the cannula portion of passage 26 creates internal pressure on the duckbill valve, thereby opening the valve. With fluid traveling in the opposite direction (from the flow outlet portion of passage 26), external pressure on the duckbill valve seals the valve closed.

9 and 10 show an embodiment where various components are coupled together to form the pump side component 12 and the 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 connection 140 . In some embodiments, 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 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 are discussed in more detail below.

In one embodiment, the cannula 32 of the patient side member 14 extends from the patient side member 14 . Passage 26b disposed about axis 24 may extend through cannula 32 and 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 together with the channel 26b of the patient-side component 14. While the pump-side component 12 and the patient-side component 14 comprise the various elements previously enumerated as depicted in FIG. When coupled together, the independent channels 26a to 26e form a single channel 26 through which fluid can flow through the device 10 . The various components may remain separate, or they may be manufactured in various combinations of integral components other than the snap-fit connection 140 and the anti-reconnection device 120 .

FIG. 12 shows an embodiment of an anti-reconnection device 120 . The anti-reconnection device 120 comprises a neck part 121 and a guide rod or cannula 32 . Channel 26 passes through both neck piece 121 and cannula 32 . Channel 26 and anti-reconnection device 120 may be positioned about axis 24 . In one embodiment, the neck member 121 defines a second valve chamber 23 in which a second valve 22 may 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 direction of flow of liquid in the device 10 .

The anti-reconnection device 120 may further include at least one securing arm 122 . The securing arms 122 are configured to allow the device 10 to be detachably coupled, thus allowing the medical line to release when a force is applied to the medical line at both ends of the device 10 . In some embodiments, a fixation arm 122 extends from the anti-reconnection device 120 at the distal end of the neck member 121 . The 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, the fixed 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 at which the fixation arm 122 is no longer parallel to the axis 24 and begins radially outward from the axis 24 at an angle greater than 90 degrees. extend. Accordingly, the clamping surface 124 extending from the fixed arm 122 at the fixed 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 Figures 17e and 18d.

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

FIG. 13 shows an embodiment of a keyway arrangement 130 . The keyway means 130 substantially corresponds to the anti-reconnection means 120 to form the patient-side part 14 . In one embodiment, the keyway arrangement 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 means 120 and keyway means 130 may correspond in such a way that they form a single second valve chamber 23 , as exhibited in FIG. 14 . The second valve 22 is insertable into the second valve chamber 23 to regulate the flow rate and flow direction of fluid in the device 10 .

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

In some embodiments, the keyway arrangement 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-reconnection device 120 when coupled to the keyway arrangement 130 (as exhibited 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 . When a medical line is disconnected, sometimes the patient or another individual may attempt to re-establish the device 10 connection. However, re-establishing the connection may be dangerous for the patient since the line may have been contaminated during the disconnection. Therefore, when the connection is established, the fixed arm 122 cannot be accessed because the fixed arm protector 136 and the shield 127 prevent direct access to the fixed arm 122 . The fixed arm 122 is only accessible via the keyhole 138 which may be seated on the fixed arm protector 136 or the shield 127 . The keyhole 138 may be configured such that the only way to access the fixed arm 122 is by using 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 IV and the patient 102 . Thus, in the event of an accidental disconnection, a medical professional can properly assess the situation to determine whether it is necessary to provide a new connection due to contamination.

FIG. 14 presents an exemplary embodiment of a patient side component 14 . The patient side component 14 may be manufactured as three separate subsections (duckbill valve 22, anti-reconnection device 120 and keyway device 130). The subsections may be assembled and coupled using common techniques such as adhesive materials, connectors, and the like. Another embodiment may be implemented as an integral configuration of subsections. This can include 3-D printing technology. It should be understood, however, that the concepts disclosed herein are not dependent on whether the patient-side component 14 is a plurality of assembled sub-sections or an integral single component.

In order to further understand the apparatus 10, the pump side component 12 will now be described in more detail. The pump-side part 12 provides an attachment point to which the fixed 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 a pump side component 12 . In some embodiments, the pump side component 12 may include a female luer lock 160 , a luer activated check valve arrangement 150 and a snap fit connection 140 . Depending on the tubing used, the pump side part 12 may comprise different subsections such as quick connects, male luer locks, bayonet connections, compression fittings, barb fittings, flare fittings, switchable valves, 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 arrangement 150 and the snap fit connection 140 may be integrated into a single in the 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 subsections 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 detachably coupled with the patient side component 14 . Additionally, channel 26 may be disposed within snap fit connection 140 . Parts 12 , 14 form a single channel 26 when channel 26 is removably coupled with patient side component 14 .

The snap fit connection 140 may also define an annular joint groove 142 . This groove 142 is configured to receive an annular joint 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 bar 146 . The securing rod 146 is configured to receive the securing arm 122 of the anti-reconnection device 120 . In one embodiment, the relationship between the fixed arm 122 and the fixed rod 146 provides the device 10 with an anti-reconnection function and a detachment function.

In some exemplary embodiments, the fixing rod 146 may further include an inclined receiving surface 148 . The angled 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 Figures 17e and 18d. The inclined receiving surface 148 of the fixed rod 146 and the clamping surface 124 of the fixed arm 122 are configured to complement each other. In some embodiments, this may result in the sloped receiving surface 148 and the clamping surface 124 being flush when the pump side component 12 is removably coupled to the patient side component 14 . Thus, when the pump side component 12 is detachably coupled to the patient side component 14, the clamping surface 124 and the angled receiving surface 148 are in substantial contact. In other embodiments, surfaces 124, 148 are substantially parallel, but not perfectly parallel, and thus cannot maintain a perfectly flush contact surface. In some embodiments, the securing arm 122 is biased slightly radially inward by the securing rod 146 when the pump side component 12 is removably coupled to the patient side component 14 . This means that the fixed arms 122 are biased radially outwards, since the material prefers to remain in an unbiased state. In other embodiments, the fixation rod 146 is positioned in such a way that the fixation arm 122 and the fixation rod 146 are in contact but the fixation arm 122 is not biased radially inward when the parts 12, 14 are removably coupled.

17a to 17f and 18a to 18e show the process of disengaging 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 component 12 from the patient-side component 14 , the securing arm 155 must pass through or leave the securing rod 146 .

As previously mentioned, sometimes, the patient or other circumstances may accidentally apply force to the IV tubing. This can result in deviation of the delivery site 100 of the patient 102, possibly causing extensive damage to the tissue of the patient 102 and severe pain. In some embodiments, the complementary nature of the angled receiving surface 148 of the securing rod 146 and the gripping surface 124 of the securing arm 122 may provide for the detachability of the pump side component 12 from the patient side component 14 . When an outward relative axial force 170 is applied across the device 10 (such as pulling an IV tubing), since the sloped receiving surface 148 and the clamping surface 124 are not parallel or perpendicular to the radial axis 126, the The inclined receiving surface 148 applies a force 172 perpendicular to the plane of the inclined receiving surface 148 to the clamping surface 124 against an outwardly applied axial force 170 . This force 172 is transmitted to the fixed arm 122 . Due to the outwardly facing axial force 170 applied across the device 10 , the fixed arm 122 will then be biased radially inwardly in accordance with the force 172 applied by the angled receiving surface 148 . See Figure 17b and Figure 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 parts 12, 14 have been disengaged, the securing arm 122 will snap back into the unbiased position, as shown in Figure 18e.

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 at which the angled receiving surface 148 and clamping surface 124 are disposed result in varying degrees of disengagement resistance. See Figure 18d. For example, if the angled receiving surface 148 and the clamping surface 124 are set at an angle close to 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 This will result in a radially inward force being applied to the fixed arm 122 and will not result in an axial force on the fixed arm 122 . The radially inward force will bias the fixed arms 122 radially inwardly. 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 . Thus, the closer the inclined receiving surface 148 and clamping surface 124 are parallel with respect to the radial axis 126, the more the forces between the two components 124 and 148 will be directed axially rather than radially. Therefore, a greater outward relative axial force 170 is required to bias the stationary arms 122 radially inward. See Figure 17e.

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 was longer, the securing arm 122 would have to be offset radially inwardly a greater distance away from the angled receiving surface 148 and securing rod 146 . More force is required to bias the securing arms 122 radially inwardly, so if greater or less outward relative axial force 170 is required for disengagement, the length of the clamping surface 124 can be increased or increased, respectively. decrease. This may create certain material stresses on the securing arm 122 , which may therefore also comprise a reinforced joint 122 a in which the securing arm 122 extends from the anti-reconnection device 120 .

Third, the texture of the sloped receiving surface 148 and the clamping surface 124 can be altered to provide more resistance. As outward relative axial force 170 is applied to device 10 , clamping surface 124 slides relative to sloped receiving surface 148 . The sliding action creates relative friction. The greater the coefficient of friction on the two surfaces 124 , 148 , the greater the outward relative axial force 170 required to disengage the device 10 . The surface areas of the two surfaces 124, 148 can be adjusted to provide different degrees of resistance. This includes larger or smaller surface 124 , surface 148 , or incomplete contact between both surfaces 124 and 148 .

Fourth, the material and thickness of the securing arms 122 can also alter the magnitude of the outward relative axial force 170 necessary to disengage the device 10 . When the fixed arm 122 comprises a thicker and more rigid material, a greater force is required to radially bias the fixed arm 122 . Accordingly, the force necessary to decouple the two parts 12, 14 may be modified to maximize the effectiveness of the device 10. For some patients or insertion points, it may be necessary to use a low threshold tension or outward relative axial force 170 to induce disengagement since the tissue or patient may be particularly vulnerable or sensitive. Other situations may require higher thresholds for decoupling. The annular joint 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-reconnection feature of the present disclosure. The fixed arm 122 further defines a deflection surface 129 . When the pump side part 12 and the patient side part 14 are uncoupled and the corresponding axes are aligned, the fixation arm 122 is aligned with the fixation rod 146 so that when the two parts 12, 14 are translated towards each other on the axis 24, the fixed The deflection surface 129 of the arm 122 contacts the fixed rod 146 . The deflection surface 129 prevents further movement and the two parts 12, 14 cannot be coupled. In some embodiments, the deflection surface 129 is positioned at an angle substantially parallel to the clamping surface 124 . The fixed rod 146 may also be angled or rounded so that when the user applies an inward relative axial force 171 to the two parts 12, 14 and the fixed rod 146 is in contact with the deflection surface 129, the fixed arm 122 will Biased radially outwards, thus preventing coupling of the two parts 12, 14.

Since the deflection surface 129 is aligned with the fixed rod 146 to prevent coupling when the fixed arm 122 is unbiased, to achieve coupling of the two parts 12, 14, the user must manually bias the fixed arm 122 radially inward , such that as the two parts 12 , 14 translate toward the other along the axis 24 , the fixed arm 122 moves away and slides past the fixed rod 146 . In some embodiments, fixed arm guard 136 prevents access of fixed arm 122 . Access is through keyhole 138 only. Certain wedges are required to bias the fixed arms 122 radially inwards. This allows the medical care provider to limit the ability to couple the two components 12, 14 to the cleated component. When an unintentional decoupling occurs, the healthcare provider can assess the situation and determine if the line can be reconnected or if a new line is required due to contamination or damage to the line.

Those skilled in the art will readily recognize that the previously described components can be placed on either of parts 12 , 14 and can be repositioned or reversed onto each of parts 12 , 14 . Accordingly, the fixed arm 122, fixed arm guard 146, and any other parts as described in the present disclosure on the patient side member 14 are relocated to the pump side member 12 as well as the fixed rod 146 and other components on the pump side member 12. It is within the scope of the present disclosure for the repositioning of accompanying components to the patient side member 14 . Furthermore, when fluid is being withdrawn from the patient 102 rather than being administered to the patient 102, the valve 20, valve 22 and activation structure (cannula 32 and activation surface 32) may reside in opposing components 12, 14 as previously described. superior.

In some embodiments, both parts 12, 14 may also include closed end caps. The closed end cap is configured to prevent contamination of components 12, internal passages and assemblies of components 14. In some embodiments, the closed end cap may include existing components such as shield 127 , fixed rod 146 , and fixed arm guard 136 . In other embodiments, the second end of the patient side member 14 is operable to act as a first closed end cap and the proximal end of the pump side member 12 is operable to act as a second closed end cap. In other embodiments, the diameter of the channel 26 and the cannula 32 provide protection against tampering of 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 channel 26 and cannula 32 prevents contact with the valves 20, 22, which could result in damage to the valves 20, 22, and Fluid loss due to damaged valve.

Since device 10 is used in fluid delivery applications, it is critical that, if a disconnection does occur, fluid flow through the device is stopped in order to prevent fluid loss in the patient and fluid leakage, eg, from an IV bag. Some embodiments may implement a series of valves to prevent fluid loss as well as cleanup and hazards from 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 disposed in the downstream portion of both components 12 , 14 . Other one-way valves as well as multi-way valves may also be implemented in various other embodiments. Thus, the duckbill valve 22 will be in the pump side component 12 downstream of the patient 102 if the patient is draining fluid, whereas the duckbill valve 22 will be close to the patient 102 if fluid is being administered to the patient 102 .

As previously discussed, the first valve 20 is required to prevent fluid from continuing to flow from the source when the two components 12, 14 have disengaged. In some embodiments, this is achieved by providing a first valve 20 that is only active when the two components 12, 14 are coupled together. This can be achieved by providing a cannula 32 extending into the pump side part 12 and activating the check or first valve 20 . 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. When the two components 12 , 14 are separated, 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 the QOSINA™ Luer Activated Check Valve.

In some embodiments, annulus junction 144 may be placed within device 10 to minimize fluid loss during decoupling. The valve activation surface 34 of the cannula 32 is not in contact with the first valve 20 when the two parts 12, 14 are separated from each other. The annular joint 144 is seated in the channel 26 such that the seal around the cannula 32 remains intact even after the first valve 20 is deactivated. Thus, 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, the system remains sealed. See Figure 17e and Figure 17f.

Thus, while specific embodiments of the present invention of the novel and applicable BREAKAWAY MEDICALTUBING CONNECTOR have been described herein, it is not intended that these references be construed as limitations on the scope of the present invention.

Claims (20)

1. A connector apparatus, comprising:

a first side member comprising a first housing having an inner wall, a first channel disposed within the first housing, and a first valve disposed within the first channel, wherein the first valve is an active valve and wherein the first valve comprises a first seal;

a second side member including a second housing, a second passage disposed within the second housing, a second valve disposed within the second passage, and a cannula extending from the second side member to the first side member; and

an annular interface between the cannula and the first side member, wherein the annular interface forms a second seal between the first side member and the second side member.

2. The connector apparatus of claim 1, wherein the loop surface engagement provides a resistive force between the first and second side members when the first and second side members are decoupled.

3. The connector apparatus of claim 2, wherein the resistance provided by the loop-engaging portion provides a first component of a separation force required to decouple the first side component from the second side component.

4. The connector apparatus of claim 3, further comprising a securing lever and a securing arm that engages the securing lever when the first side member is coupled with the second side member.

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

6. The connector apparatus of claim 5, wherein the second seal of the circumferential interface remains engaged after the fixed rod and the fixed arm are disengaged when the first side member is decoupled from the second side member.

7. The connector apparatus of claim 5, wherein the first seal closes before the second seal opens when the first side component is decoupled from the second side component.

8. The connector apparatus of claim 1, where the annulus joint has an annular shape.

9. The connector apparatus of claim 1, where the annular surface engagement comprises a sealing member that surrounds the cannula when the first side component is coupled with the second side component.

10. The connector apparatus of claim 9, wherein the sealing member of the sealing member surrounding the cannula remains in contact with the cannula after the first valve is closed when the first side component is decoupled from the second side component.

11. The connector apparatus of claim 1, wherein the annular surface engagement 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 with the second side member.

12. The connector apparatus of claim 11, wherein the O-ring remains in contact with the cannula after the first seal is closed while the first side component is decoupled from the second side component.

13. A method of using a detachable line connector, comprising:

providing a first side member comprising a first housing having an inner wall, a first channel disposed within the first housing, and a first valve disposed within the first channel, wherein the first valve is an active valve and forms a first seal;

providing a second side member comprising a second housing, a second passage disposed within the second housing, a second valve disposed within the second passage, and a cannula extending from the second side member to the first side member; and

an annular interface is provided between the cannula and the first side member, wherein the annular interface provides a second seal around the cannula.

14. The method of claim 13, further comprising an annulus joint groove defined in the first side member, and a sealing member disposed in the annulus joint groove, wherein the cannula is received through the sealing member.

15. The method of claim 14, wherein the sealing member is an O-ring and the cannula extends through the O-ring.

16. The method of claim 13, further comprising decoupling the first side component from the second side component.

17. The method of claim 16, wherein the circumferential joint provides a resistance force when the first side component is decoupled from the second side component.

18. The method of claim 17, wherein the resistance provided by the circumferential interface provides a component of the axial separating force required to decouple the first side component from the second side component.

19. The method of claim 18, further comprising maintaining engagement of the second seal of the annulus joint after the first seal closes while the first and second side members are decoupled.

20. The method of claim 19, further comprising disengaging the second seal after the first seal is closed while the first and second side members are decoupled.

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