CN112618085B

CN112618085B - Bile duct catheter device

Info

Publication number: CN112618085B
Application number: CN202011479206.9A
Authority: CN
Inventors: 段继峰; 徐小宝; 俞诚
Original assignee: Pharmalegacy Laboratories Shanghai Co ltd
Current assignee: Pengli biomedical technology (Shanghai) Co.,Ltd.
Priority date: 2020-12-15
Filing date: 2020-12-15
Publication date: 2021-08-31
Anticipated expiration: 2040-12-15
Also published as: CN112618085A

Abstract

The invention relates to a bile duct conduit device, which is provided with a first branch for communicating with a bile duct and a second branch for communicating with duodenum. The first branch rear end and the second branch rear end are connected to each other. The duct device also comprises a third branch for communicating with the outside, the rear end of the third branch being connected to the rear ends of the first and second branches in such a way as to communicate with the first and second branches, respectively, and lying in the same plane as the first and second branches. The device has few sterilization dead angles when in use, and can ensure the normal circulation of bile to duodenum, thereby ensuring the accuracy of a medicine experiment.

Description

Bile duct catheter device

Technical Field

The invention relates to the technical field of bile ducts, in particular to a bile duct device.

Background

Pharmacokinetics plays an important role in the development of new drugs, and the bile excretion process of new drugs in animals is often performed in preclinical pharmacokinetic studies. Based on the characteristics of the existing experimental animal species, the rat bile duct intubation model is the most common model for bile excretion studies. The success rate of bile duct cannulation procedures in rats and the impact on rat health have become increasingly of concern.

Bile excretion tests are important items of pharmacokinetic research, and at present, bile duct intubation operations of rats mainly comprise two major types, wherein the first type is that one duct is inserted into a bile duct, the other duct is inserted into duodenum, and the two ducts can be in butt joint to form a closed loop outside an animal body. During the recovery period of the operation (usually 3 days), the two catheters are in a butt joint closed state, so that the bile can flow into duodenum to facilitate the recovery of the health after the operation. At the beginning of the experiment to collect bile, the junction of the two catheters was disconnected to begin collecting bile. The method has the advantages that the drug research can be started after the operation of the animal is recovered, so that the research can be carried out under the condition that the experimental animal is healthier as far as possible, but the method has the defects that one operation needs to insert two catheters, the two catheters are thin and unstable in fixation, and the experiment is easy to fall off, so that the experiment fails. And it is difficult to control microorganisms at the junction of the two tubes, making the animal susceptible to infection by bile draining into the duodenum through the junction. The success rate of the operation is low, which wastes time, money and experimental animals; the second type is that only one catheter is inserted into the bile duct, and the bile is collected for experiment without postoperative recovery after the operation is finished. The method has the advantages of high success rate of operation and large difference between the experimental animal and the healthy animal, which can affect the accuracy of the experimental result. There is a temporary absence in the prior art of a biliary duct device that addresses the above-mentioned problems, and improvements to existing ducts are needed to overcome the above-mentioned deficiencies of the prior art.

Furthermore, on the one hand, due to the differences in understanding to the person skilled in the art; on the other hand, since the inventor has studied a lot of documents and patents when making the present invention, but the space is not limited to the details and contents listed in the above, however, the present invention is by no means free of the features of the prior art, but the present invention has been provided with all the features of the prior art, and the applicant reserves the right to increase the related prior art in the background.

Disclosure of Invention

In response to the deficiencies of the prior art, the present invention provides a bile duct conduit device having a first branch for communicating with a bile duct and a second branch for communicating with a duodenum. The first branch includes a front end and a back end and the second branch includes a front end and a back end. In the case of bile secretion and pressure outflow-based, the first branch rear end of the first branch for receiving pressure outflow-based bile for guiding the bile entering the first branch through the first branch front end into the catheter device is connected to the second branch rear end in such a way that the bile can be guided from the rear end of the first branch into the second branch under pressure and through the second branch rear end to the second branch front end into the duodenum. The catheter device further comprises a third branch for communicating with the outside, the third branch comprising a front end and a rear end, and the rear end of the third branch being connected to the rear end of the second branch in such a way that bile reaching the rear end of the first branch via the front end of the first branch can be guided to reach the front end of the third branch via the rear end of the third branch and flow out of the animal body when the second branch is blocked. Under the condition that the rear end of the first branch is respectively connected with the rear end of the second branch and the rear end of the third branch, the second branch and the third branch share the same axis, an included angle alpha exists between the first branch and the third branch, the second branch and the first branch form an included angle beta, and the included angle alpha is smaller than the included angle beta according to the mode that bile flowing to the rear end of the first branch preferentially flows into the second branch.

In other words, the angle α of the first branch to the third branch, viewed in the bile flow direction, is smaller than the angle β of the first branch to the second branch, preferably at least 30 ° to 55 °, particularly preferably 45 °, particularly preferably 50 °. The setting of the included angle α and the included angle β not only takes into account the flow resistance, but also is limited to the shape after implantation in a lateral posture in a rat (after implantation, the front end of the third branch is located behind the ear of the rat, the second branch and the first branch are both located in the abdomen, and for the case that the posture of the implant changes during the movement of the rat, particularly during the forward pushing of the hind limb or the twisting of the trunk during the movement of the rat, "the current setting of the included angle α and the included angle β" and "the setting of the coaxial line of the second branch and the third branch" avoid the outward throwing of bile, and are particularly advantageous for the case that the pedal of the hind limb generates a large pressure on the abdominal muscle and a large acceleration within a short time on the implant.

According to a preferred embodiment, the catheter device further comprises a stopper capable of blocking the second branch when the stopper is in the operative position in the second branch, and a guide wire for conveying the stopper from the third branch to the operative position in the second branch. When the guide wire is used to insert the blocking object into the second branch, the setting of the included angle α and the included angle β according to the present invention advantageously avoids the situation that the flexible blocking object is mistakenly inserted into the first branch, and the co-axial posture of the second branch and the third branch is also benefited.

According to a preferred embodiment, the inner diameter of the second branch is 0.5mm-2mm smaller than the inner diameter of the third branch. The first branch has an inner diameter smaller than the inner diameters of the second and third branches.

According to a preferred embodiment, the second branch further comprises an electrically operated valve for controlling the blocking or unblocking of the second branch, the electrically operated valve arranged inside the second branch being opened on the basis of an external control in such a way that the second branch is unblocked in case the catheter device is arranged inside the animal without the need for sampling, and the electrically operated valve arranged inside the second branch being closed on the basis of an external control in such a way that the second branch is blocked in case the animal is to be sampled. According to a preferred embodiment, the front end of the third branch further includes a plug for plugging the front port of the third branch, and the plug is detachably connected to the front end of the third branch in a manner that the third branch can be changed from a plugging state to a communicating state based on an external force.

According to a preferred embodiment, the guide wire is connected detachably or fixedly to the block, and in the operating position of the block, the guide wire can be withdrawn from the block or remain connected to the block and remain in the second branch.

According to a preferred embodiment, the rear end of the first branch and the rear end of the second branch are integrally formed with or fixedly connected to the rear end of the third branch. Preferably, the first, second and third branches are formed in one piece using a two-component injection molding process, wherein the first and second branches are made of a softer material and the third branch is made of a softer material that is harder than the first and second branches. The implant forms an elongated rod due to the coaxial arrangement of the second and third branches, which prevents the normal movement of the rat (typically, the forward movement of the rat includes the steps of hind limb pedaling, abdominal muscle contraction, abdominal muscle extension, and forward limb extension). In order to avoid that the long rod piece causes preference dormancy for rats, reduces food intake and further influences bile experiment results, the second branch and the first branch are set to be softer materials, and in the injection molding process, the relationship between the included angle alpha and the included angle beta set by the invention is beneficial to reducing the resistance of injection molding liquid flowing to the second branch when the first branch is used as a soft material injection port, and in the second injection molding process, the third branch is used for completing injection molding relative to the harder materials of the first branch and the second branch, so that the required materials are limited, the process is simple, and demolding is convenient. Therefore, the invention reduces the cost of the injection mold and is beneficial to completing the double-component injection molding at high speed. The soft second branch and the soft third branch do not interfere with the implantation operation under the condition of coaxial setting, are still convenient for guide wire sampling, and cause minimal interference to the movement of the rat.

According to a preferred embodiment, the rear end of the first branch is provided with a first fixing point.

According to a preferred embodiment, the second branch front end is provided with a second fixing point and the third branch front end is provided with a third fixing point. According to a preferred embodiment, the surface of the first, second and/or third branch is provided with a titanium coating or parylene bio-coating in such a way that it can be protected to maintain a normal working condition for a long time.

The invention has the beneficial technical effects that:

firstly, the sampling is convenient and the infection is not easy to happen. The branch is fixedly connected into a pipe, the pipe is tightly connected, so that the conditions of pipe detachment or harmful microorganism hiding and the like can not occur in the process of fluid circulation, the fixation is stable and convenient, and the recovery of animals is facilitated; through the setting of seal wire, stifled thing and end cap, change the position of stifled thing and the switch of end cap can change the flow direction of the interior fluid of pipe, when stifled thing was sent to the operating position, the second branch can be stopped up, and the fluid just can be through first branch to the third branch, and such mode of operation is easy and simple to handle, and is difficult for polluting.

Second, a single trauma reduces the failure rate of the experiment. After the catheter is placed into in once operation, only need control the second branch when sampling once more lead to stifled state control bile and get into animal normal bodily circulation or flow out and sample, and need not carry out many times operation and control the catheter connection condition, reduce the risk of animal infection that many times operation caused, reduce the lethality rate of animal, reduce the failure rate of experiment.

Thirdly, the sampling accuracy is high. When the experiment is carried out, the bile can reach the duodenum from the bile duct through the first branch and the second branch, so that the normal bile circulation in the animal body can be maintained, the state of the experimental animal is close to the normal physiological state to the maximum extent, and the accuracy of the experimental result can be improved by carrying out the drug experiment under the state.

Drawings

FIG. 1 is a schematic structural view of a preferred embodiment of an uninserted guidewire and occlusion of the present invention;

FIG. 2 is a schematic structural view of a preferred embodiment of the insertion guidewire and closure of the present invention;

fig. 3 is a schematic structural view of another preferred embodiment of the present invention.

List of reference numerals

100: first branch 100 a: first branch leading end 100 b: first branch rear end

200: second branch 200 a: second branch leading end 200 b: second branch rear end

300: third branch 300 a: third branch front end 300 b: third branch rear end

401: blocking object 100 d: first fixing point 200 c: second fixing point

402: the guide wire 403: plug 300 c: third fixing point

201: electric valve

Detailed Description

The following detailed description is made with reference to the accompanying drawings.

Example 1

Fig. 1, 2 and 3 show a bile duct catheter device having a first branch 100 and a second branch 200. The first branch 100 includes a front end 100a and a rear end 100 b. The second branch 200 comprises a front end 200a and a rear end 200b, the first branch front end 100a being intended for insertion into the bile duct. The second branch leading end 200a is for insertion into the duodenum. In the case of bile secretion and pressure outflow-based, the first branch rear end 100b of the first branch 100 for receiving the pressure outflow-based bile for guiding the bile entering the first branch 100 through the first branch front end 100a is connected to the second branch rear end 200b in such a manner that the bile can be guided by the first branch rear end 100b into the second branch 200 on the basis of gravity and reach the second branch front end 100a through the second branch rear end 200b and then enter the duodenum, so as to ensure normal bile circulation and material digestion of the animal body, thereby enabling it to be maintained in a normal healthy state, so as to ensure accuracy of experimental results.

The catheter device further comprises a third branch 300 for communication with the environment. The third branch 300 comprises a front end 300a and a rear end 300b, the third branch front end 300a being adapted to communicate the catheter device to the outside for conducting bile out of the body when the catheter device is used for performing a pharmacological analysis of an animal, in order to collect bile outside the body. The third branch rear end 300b and the second branch rear end 200b are connected to each other. Under the condition that the second branch 200 is blocked, bile at the rear end 100b of the first branch is led out of the body through the rear end 300b of the third branch and the front end 300a of the third branch, so that non-invasive sampling in the body is realized, the damage to the animal is reduced, and the infection rate of the animal is reduced. The second branch 200 is coaxial with the third branch 300 in a state where the first branch rear end 100b is connected to the second branch rear end 200b and the third branch rear end 300b, respectively. And when the first, second and

third branches

100, 200 and 300 are in fluid communication with each other through their respective rear ends, the axis of the first branch 100 is in the same plane as the common axis of the second and

third branches

200 and 300. Preferably, the material of the first, second and

third branches

100, 200 and 300 may be a semi-rigid material such as PVC, TPE, silicone, latex, plastic, etc. The first branch 100, the second branch 200 and the third branch 300 which are in the same plane have included angles with different sizes, the first branch 100 and the third branch 300 have included angles alpha, the second branch 200 and the third branch 300 form an included angle beta, and the included angle alpha is at least 30-55 degrees smaller than the included angle beta, so that the fluid flow resistance from the first branch 100 to the second branch 200 is smaller than the flow resistance from the first branch 100 to the third branch 300, so that the bile of the animal can preferentially reach the second branch 200 through the first branch 100 after the catheter device is placed in the animal and is coupled with the bile duct and duodenum of the animal, and therefore, the animal can be kept as close to a healthy state as possible when sampling is not needed, and deviation of experimental data is reduced. And bile does not easily enter the third branch 300 to leak when the second branch 200 is unobstructed.

According to a preferred embodiment, as shown in fig. 2, the catheter device further comprises an occlusion 401 for occluding the second branch and a guide wire 402 for delivering the occlusion. Under the condition that in vitro sampling is needed, the blocking object 401 for blocking the second branch is conveyed into the second branch 200 under the driving of an external force through the guide of the guide wire 402, when the blocking object 401 is located at the working position in the second branch 200 for bile to flow into the duodenum, the blocking object 401 can block the bile flow channel inside the second branch 200, so that the bile cannot reach the duodenum along the preferential passage from the first branch 100 to the second branch 200, but flows out of the body from the front end 300a of the third branch through the passage from the first branch 100 to the third branch 300, and therefore a user can collect the bile in the body without communicating a catheter in a manner of taking operation on the animal again, the risk of animal infection is reduced, and the survival rate of the animal is increased. Preferably, the stopper 401 may be any sterilized fine bead or cotton capable of blocking the second branch 200. The guide wire 402 is used to transport the blockage 401 from the third branch 300 to a working position in the second branch 200, thereby blocking the second branch 200. The guidewire 402 is provided as an elongate, threadlike member having a diameter less than the inner diameter of the third and

second branches

300, 200 in a manner to freely shuttle within the second and

third branches

200, 300. In use, the stopper 401 and the guide wire 402 are sterilized and then delivered to the second branch 200 through the third branch 300, so that the second branch is blocked.

Preferably, the guide wire 402 is rigid in such a way that when an external force is applied to its proximal end close to the user in the direction in which it extends, so that it moves a certain distance in the direction close to the second branch 200 with respect to the third branch 300, its distal end away from the user can also move the same distance in the direction close to the second branch 200. For example, the guide wire may be implemented as a material having a certain rigidity and corrosion resistance, such as steel, iron, glass, and the like. The guide wire 402 with the blocking object 401 enters the catheter device from the third branch front end 300a, and the third branch 300 and the second branch 200 are coaxial, so that the guide wire 402 with the blocking object 401 can easily enter the second branch 200, the blocking object 401 blocks the second branch 200, bile cannot enter duodenum from the first branch 100 through the second branch 200, and the bile can reach the third branch and the rear end 300b under the condition that the bile is accumulated at the first branch rear end 100b and is transported out of an animal body through the third branch 300. Preferably, the rigid guidewire 402 is removably attached to the blockage 401. Under the condition that the blocking object 401 is at the working position, namely after the guide wire 402 pushes the blocking object 401 to the working position, the guide wire 402 can be disconnected from the blocking object 401 based on the control of external force, so that the guide wire 402 can realize independent original path return, bile can smoothly flow out from the third branch 300, the bile flow channel can not be blocked or the flow resistance in the pipeline can be increased to accelerate the bile flow speed due to the existence of the guide wire 402, the sampling time is saved, and the problem that the air in the air enters the animal body after carrying harmful microorganisms through the third branch 300 and the first branch 100 in a long-time sampling process, the animal infection is caused to influence the accuracy of experimental data or the experimental failure is caused is solved. The detachable connection mode can be a magnetic attraction abutting mode or a detachable connection mode known by a person skilled in the art through hooks and clips.

For example, the guidewire 402 and the blockage 401 may be removably attached by a clip. The clip includes a first jaw and a second jaw which cross each other and are connected to each other by a spring. The distal connection of the guidewire 402 away from the user intersects the first and second jaws. The first and second jaws have front and rear ends, respectively. In the case where the first and second jaws are connected to each other by a spring, the front ends of the first and second jaws abut against each other in such a manner as to constitute a receiving space for receiving all or a part of the stopper 401. The rear ends of the first clamping piece and the second clamping piece are movably connected with a Y-shaped thin line, and the rear ends of the first clamping piece and the second clamping piece are respectively connected with two short branches of the Y-shaped thin line. The long branch of the "Y" shaped thread is connected to the guide wire 402 and led out of the body through the third branch tip 300 a. When the guide wire 402 conveys the plug 401 through the third branch 300 and enters the second branch, the front ends of the first and second jaws hold the plug 401 in the accommodating space formed by the front ends of the first and second jaws together in a manner that the plug 401 and the guide wire 402 can be kept connected. When the plug 401 is in the working position, i.e. after the guide wire 402 has delivered the plug 401 to the appropriate position, the front ends of the first and second jaws are guided away from each other by their rear ends, which are close to each other, in a manner enabling the disconnection of the guide wire 402 from the plug 401, based on the force exerted by the user at the long branch of the Y-shaped filament towards the outside of the animal. When the blockage is required to be moved out of the second branch after sampling is finished, the guide wire 402 carrying the clamp is used again to extend into the catheter from the third branch, the long branch of the Y-shaped thin line is pulled again to place part or all of the blockage 401 in the accommodating cavity formed by the front ends of the first clamping piece and the second clamping piece, so that the guide wire 402 and the blockage 401 are kept connected again, a user can guide the blockage 401 away from the working position again through the guide wire 402, a bile flow channel inside the second branch 200 is enabled to be unblocked, bile can flow from the bile duct to the duodenum through the first branch 100 and the second branch 200 again, and normal bile circulation in the animal body is restored again. Preferably, the guide wire 402 is fixedly connected with the blocking object 401, after the guide wire 402 sends the blocking object 401 to the working position, the guide wire 402 is connected with the blocking object 401, the guide wire 402 is also held in the second branch 200 and the third branch 300, so that after sampling is finished, the guide wire 402 can carry the blocking object 401 to exit the third branch again, so that the first branch 100 is communicated with the second branch 200 again, and bile of the animal can reach the duodenum from the bile duct through the first branch 100 and the second branch 200 again, so as to ensure the health state of the animal when the animal is not sampled.

According to a preferred embodiment, the inner diameter of the second branch 200 is at least 0.5mm smaller than the inner diameter of the third branch 300, for example, when the diameter of the second branch 200 is 4mm, the diameter of the third branch 300 is 4.1mm to 6 mm. So that the blockage 401 entering the second branch 200 from the third branch 300 can unblock the passage of the second branch 200 without getting stuck in the third branch 300. Preferably, the outer diameter of the plug 401 is equal to the inner diameter of the second branch 200.

According to a preferred embodiment, the inner diameter of the first branch 100 is smaller than the inner diameter of the second and

third branches

200, 300 in order to provide a positive sealing connection with the bile duct of the animal body, and the bile after flowing out through the first branch 100 to the second and third branches is not easily able to flow back into the bile duct through the first branch 100 due to the operation of the animal or the operator.

According to a preferred embodiment, as shown in fig. 3, the second branch is internally provided with an electrically operated valve (201) in such a way as to be able to block the second branch. In the case where the catheter device is installed in the body of an animal and bile of the animal is secreted and flows out under pressure, the electrically operated valve (201) installed inside the second branch 200 is opened based on external control in such a manner that the second branch 200 can be unblocked, so that the bile can flow into the duodenum from the bile duct through the first branch front end 100a, the first branch rear end 100b, the second branch rear end 200b, and the second branch front end 200a, and normal body fluid circulation of the animal is maintained, so that the animal can rapidly recover a healthy state. When the catheter device is installed in an animal body and the animal needs to be sampled, the electrically operated valve 201 installed in the second branch 200 is closed in such a manner that the second branch 200 is blocked based on external control, so that bile cannot reach the duodenum through the first branch 100 and the second branch 200, but due to the presence of the third branch 300, the bile is collected at the rear end 100b of the first branch and then flows out of the body through the rear end 300b and the front end 300a of the third branch, thereby achieving sampling. The electrically operated valve 201 is in signal connection with an external control device in a wired or wireless manner in such a manner as to be capable of being controlled externally. Preferably, the electrically operated valve 201 is fixedly connected to an outer wall of the second branch and is subjected to a waterproof treatment to ensure the normal operation of the electrically operated valve 201. Preferably, when the electrically operated valve 201 is electrically connected to an external control device, the electrical connection lines are embedded in the walls of the second and

third branches

200, 300 in such a way as to be able to supply power to the electrically operated valve 201 and to transmit control signals independently of the flow of liquid inside the second branch 200.

Through the arrangement mode, only the sterilized catheter device with the electric valve 201 is placed into the animal body, and no secondary operation or any device is placed into the catheter through external control, so that the probability of infection of the animal caused by introduction of microorganisms due to operation initiation or sampling is further reduced. According to a preferred embodiment, the front end 300a of the third branch further comprises a plug 403, the plug 403 being used to plug the front end of the third branch 300. At non-sampling time nodes, the plug 403 is cooperatively connected with the third branch front end 300a in a manner that can plug the third branch 300 to avoid bile leakage and air ingress. So that when the third branch 300 is not used, the opening of the third branch 300 can be blocked, thereby avoiding the infection of animals caused by harmful microorganisms and air entering the first branch 100 and the second branch 200, and simultaneously avoiding the leakage of bile from the first branch 100 to the third branch 300 in the moving process of the animals. The plug 403 for plugging the third branch is detachably connected with the front end 300a of the third branch in the external environment outside the animal body in a separable manner based on external force, so that the plug 403 can convert the front port of the third branch 300 from a plugging state to a communicating state under the action of the external force. The detachable connection means can be a screw connection, a plug connection, and the like, which are known to those skilled in the art.

According to a preferred embodiment, the first branch rear end 100b, the second branch rear end 200b and the third branch rear end 300b are integrally formed or fixedly connected, so as to facilitate the production and save materials and processes. Meanwhile, the device can prevent the connection points of the first branch 100, the second branch 200 and the third branch 300 from loosening or hiding microorganisms which are difficult to control when in use, so that the animals can be prevented from being infected and killed. And the device has good stability when in use.

According to a preferred embodiment, the first branch rear end 100b is provided with a first fixation point 100d for increasing the friction of the first branch rear end 100b with the animal muscle or skin. Preferably, the second branch front end 200a is provided with a second fixation point 200c for increasing the friction of the second branch with the duodenum of the animal. Preferably, the third branch front end 300a is provided with a third fixing point 300c for increasing the friction of the third branch front end 300a with the skin or muscle of the animal. The first, second and third fixing points are convex rings or convex points which protrude from the first, second and

third branches

100, 200 and 300, respectively, but do not affect the fluid communication of the first, second and

third branches

100, 200 and 300, and are designed integrally with the first, second and

third branches

100, 200 and 300, for example, and the shape of the convex points may be circular or drop-shaped.

According to a preferred embodiment, the surface of the first branch 100, the second branch 200 and/or the third branch 300 is provided with a titanium coating or parylene bio-coating having a thickness ranging from 2nm to 20nm, in such a way as to reduce the corrosion of bile to maintain the stable function of the catheter in vivo. The first branch 100 is of a size equal to the bile duct to ensure accurate binding to the animal. For the sake of understanding, the practical application of the catheter device will be described below by taking the model of rat bile duct intubation as an example:

in using the bile duct guiding device of the present invention, the rat is anesthetized, and then placed in a supine position, the abdomen is preserved, sterilized, and the common bile duct is found by incising the abdomen under the xiphoid process, the first branch front end 100a is inserted into the bile duct toward the liver, and the junction of the first branch 100, the second branch 200, and the third branch 300 is fixed to the mesentery of the rat by the first fixing point 100d of the first branch rear end 100 b. The second branch distal end 200a is then inserted into the duodenum, and the duodenum is fixed to the second branch distal end 200a by extending into the duodenum using the second fixing point 200 c. Finally, the front end 300a of the third branch 300 is penetrated out of the subcutaneous tunnel, the third branch 300 is made into the subcutaneous tunnel from the incision of the abdominal cavity of the rat, the tunnel outlet is selected to be 0.8-1.5cm under the midpoint of the two ears, and the third branch 300 of the bile duct is fixed by fixing a third fixing point 300c under the rat skin and extending the front end of the third branch 300 out of the skin. Or, the third branch 300 is used for making a subcutaneous tunnel from the incision of the abdominal cavity of the rat, the tunnel outlet is selected at the back, the rat is fixed through a third fixing point, a commercially available vest is passed through the rat, and the cannula is butted on the vest for protection.

It should be noted that the above-mentioned embodiments are exemplary, and that those skilled in the art, having benefit of the present disclosure, may devise various arrangements that are within the scope of the present disclosure and that fall within the scope of the invention. It should be understood by those skilled in the art that the present specification and figures are illustrative only and are not limiting upon the claims. The scope of the invention is defined by the claims and their equivalents.

Claims

1. A bile duct apparatus having a first branch (100) for communicating with a bile duct and a second branch (200) for communicating with a duodenum, the first branch (100) comprising a front end (100a) and a rear end (100b), the second branch (200) comprising a front end (200a) and a rear end (200b), a first branch rear end (100b) of the first branch (100) for receiving pressure outflow-based bile for guiding the bile into the duct apparatus in a case of bile secretion and pressure outflow-based, being connected to each other with the second branch rear end (200b) in such a manner that the bile can be guided from the rear end (100b) of the first branch into the second branch (200) and via the second branch (200) into the duodenum,

the catheter device further comprises a third branch (300) for communicating with the outside, the third branch (300) comprising a front end (300a) and a rear end (300b), the rear end (300b) of the third branch being connected to the rear end (200b) of the second branch and the rear end (100b) of the first branch, respectively, in such a way that bile is allowed to pass from the rear end (300b) of the third branch to the front end (300a) of the third branch and to the outside of the animal body, in case the second branch (200) is blocked; the second branch (200) further comprises a blockage (401) for blocking the second branch (200) so that bile cannot pass through the second branch (200) and a guide wire (402) for conveying the blockage (401) to the working position, when the blockage (401) is located at the working position in the second branch (200), the blockage (401) can block the second branch (200) to cut off the bile flow in the second branch (200), and the guide wire (402) is connected with the blockage (401) in a mode that the blockage (401) can be conveyed from the third branch (300) to the working position in the second branch (200);

the guide wire (402) is provided with rigidity in such a way that when an external force towards the extending direction is applied to the proximal end close to the user so that the guide wire can move for a certain distance relative to the third branch (300) towards the second branch (200), the distal end far away from the user can also move for the same distance towards the second branch (200);

under the condition that first branch rear end (100b) is connected second branch rear end (200b) and third branch rear end (300b) respectively, second branch (200) with third branch (300) coaxial line, first branch (100) with there is contained angle alpha between third branch (300), second branch (200) with first branch (100) form contained angle beta, contained angle alpha is less than contained angle beta according to the mode that the bile that flows to first branch rear end preferentially flows into second branch.

2. The catheter device according to claim 1, wherein the inner diameter of the second branch (200) is 0.5mm-2mm smaller than the inner diameter of the third branch (300), and the inner diameter of the first branch (100) is smaller than the inner diameters of the second branch (200) and the third branch (300).

3. The catheter device as claimed in claim 1, characterized in that the second branch (200) further comprises an electrically operated valve (201) for controlling the occlusion or unblocking of the second branch (200), the electrically operated valve (201) arranged inside the second branch (200) being opened in such a way that the second branch (200) is unblocked on the basis of an external control in case the catheter device is arranged in the animal without the need for sampling, and the electrically operated valve (201) arranged inside the second branch (200) being closed in such a way that the second branch (200) is occluded on the basis of an external control in case the animal needs to be sampled.

4. The catheter device according to claim 2, wherein the third branch leading end (300a) further comprises a plug (403) for plugging a front port of the third branch (300), wherein the plug (403) is detachably connected with the third branch leading end (300a) in a manner that the third branch (300) can be communicated with the outside in a fluid manner based on an external force.

5. A catheter device according to claim 4, wherein the guide wire (402) is detachably or fixedly connected to the stopper (401), the guide wire (402) being capable of being disconnected from the stopper (401) or remaining connected to the stopper (401) in the operative position of the stopper (401).

6. Catheter device according to claim 5, wherein the first branch rear end (100b) is provided with a first fixation point (100 d).

7. Catheter device according to claim 6, wherein the second branch front end (200a) is provided with a second fixation point (200c) and the third branch front end (300a) is provided with a third fixation point (300 c).

8. Catheter device according to one of the preceding claims, characterized in that the surface of the first branch (100), the second branch (200) and/or the third branch (300) is provided with a titanium coating and/or a parylene bio-coating in such a way that it can be protected to maintain normal working conditions for a long period of time.