Biliary tract inside and outside drainage device

By designing a bile duct drainage device that combines internal and external drainage areas with a rigid sheath structure, the problems of bile not entering the intestine affecting digestion and the susceptibility of internal and external drainage to infection were solved, achieving stable drainage and reducing the re-obstruction rate.

CN223682841UActive Publication Date: 2025-12-19LIAONING PROVINCIAL CANCER HOSPITAL
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Patent Information

Application Number
CN202422947206.7
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-12-02
Publication Date
2025-12-19
Estimated Expiration
2034-12-02

AI Technical Summary

Technical Problem

In existing biliary drainage techniques, external drainage prevents bile from entering the intestines, affecting food digestion. Long-term loss can lead to electrolyte imbalances in the body. Both internal and external drainage are susceptible to intestinal pressure, which can cause biliary tract infections, and stents may cause re-obstruction.

Method used

Design a biliary drainage device including a drainage catheter, a fixing wire and a rigid sleeve, an internal drainage area, a stenotic segment coverage area and an external drainage area. The rigid sleeve is used to straighten and shape the area to achieve internal and external drainage. Multiple side holes are set in the middle of the catheter to promote sufficient drainage.

Benefits of technology

It achieves stability of internal and external drainage, reduces the risk of infection, improves patient comfort, simplifies the procedure, and reduces the re-obstruction rate.

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model discloses a biliary tract inside and outside drainage device which comprises a drainage catheter, a fixing stay wire and a hard sleeve. The drainage catheter is composed of an inner drainage area, a narrow section covering area, a shaping area and an outer drainage area, and the interior of the drainage catheter is of a hollow structure. One end of the inner drainage area is designed into a cylindrical cone; a clamping table is arranged at one end of the outer drainage area and used for connecting a cap or a drainage bag; side holes penetrating through the inner cavity are formed in the outer walls of the inner drainage area and the shaping area; a marker point is arranged between the rear end of the side hole of the inner drainage area and the narrow section coverage area; the shaping area is curled into a loop in a natural state, and the shaping area can be straightened through the hard sleeve; the narrow section coverage area is distributed between the inner drainage area and the shaping area; the fixing stay wire comprises a fixing piece and a stay wire, and the tail end of the stay wire is connected with the fixing piece. The drainage catheter main body adopted by the utility model is made of a material with good biocompatibility; and internal drainage and external drainage can be realized. Multiple side holes are formed in the middle and the head end of the drainage tube, sufficient drainage is promoted, and infection risks are reduced.
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Description

TECHNICAL FIELD

[0001] The utility model relates to the field of medical equipment, in particular to a biliary tract internal and external drainage device. BACKGROUND

[0002] Percutaneous transhepatic cholangial drainage (PTCD) refers to a series of techniques under the guidance of imaging equipment (usually DSA X-ray perspective or B-ultrasound) to puncture the bile duct through the skin and liver and place a drainage tube to make the bile flow to the outside of the body or the duodenum. It is mainly used for the treatment of biliary obstruction and acute inflammation. It includes external drainage, internal drainage and internal and external drainage, and is the basic technology of all biliary obstruction interventional treatment. The specific steps are as follows: find a suitable puncture point, make a small hole on the skin with a sharp knife after local anesthesia. Ask the patient to pause breathing, quickly stab the thick needle into the pre-selected bile duct under ultrasonic monitoring, pull out the needle core after the breakthrough feeling of entering the bile duct, insert the guide wire after the bile flows out smoothly, continuously rotate and change direction to make the guide wire pass through the obstruction end or the narrow section into the distal bile duct or the duodenum, withdraw the puncture needle, expand the channel with a dilating tube, then pass the multi-side hole catheter through the obstruction end or the narrow section with the guide wire, so that the side holes of the catheter are located above and below the obstruction end or the narrow section, fix the catheter, and then inject contrast medium after the bile flows out smoothly from the catheter. Observe the fixed position of the drainage tube. Among them, the catheter is not easy to break, and the inner and outer walls are smooth.

[0003] For patients with malignant biliary obstruction (MBO) who cannot be treated by surgery, stent placement and PTBD are effective means to relieve jaundice, and PTBD can be divided into external drainage and internal and external drainage,

[0004] At present, the bile flows to the outside of the body along the drainage tube to quickly solve the problem of whole body yellowing, which is external drainage. Although external drainage can quickly reduce jaundice, the bile has not entered the intestinal tract, which is not conducive to food digestion, and long-term loss of bile leads to ion disorder in the body. Although patients are advised to drink the discharged bile in clinical practice, the patient's compliance is poor. At the same time, the patient needs to hang the bag for a long time, which seriously affects the patient's quality of life. Therefore, another drainage method is internal and external drainage, which sends the guide wire through the narrow place and into the intestinal tract. Then along the guide wire, the drainage tube is sent into the intestinal tract, so that a channel is established, which can connect the intestinal tract and the drainage tube. The bile can flow into the intestinal tract along the drainage tube and flow out of the body. It can quickly reduce jaundice and make the bile enter the intestinal tract to help digest food and reduce electrolyte loss. However, compared with external drainage, the catheter head end is located in the intestinal tract, which is easily affected by the pressure in the intestinal tract. When the pressure in the intestinal tract is high, the intestinal contents are easy to flow back into the bile duct, which leads to biliary tract infection, which affects the effect of internal and external drainage to some extent.

[0005] Biliary stents can improve the quality of life of patients, but the causes of stent restenosis are various, in addition to the reasons such as tumor growing inward through the mesh or growing sludge or stones at both ends of the stent, the stent itself also occupies a certain space, to a certain extent, reduces the inner diameter of the bile duct, promotes the deposition of some components in the bile, and further causes the bile duct restenosis. The inner diameter of the drainage tube is smaller than that of the stent, and lacks the mesh like the stent, so the probability of external drainage tube obstruction caused by tumor compression is relatively low, in addition, the drainage tube patient replaces the drainage tube every three months, which also reduces the restenosis rate to a certain extent. Practical new type content

[0006] To solve the above technical problems, the purpose of the present application is to provide an internal and external biliary drainage device, and the specific technical solutions are as follows:

[0007] An internal and external biliary drainage device, comprising a drainage catheter, a fixed pull wire and a hard sleeve;

[0008] The drainage catheter is composed of an internal drainage area, a narrow segment covering area, a shaping area and an external drainage area, and the inside is a hollow structure;

[0009] The end of the internal drainage area is designed as a cylindrical cone;

[0010] The external drainage area is provided with a clamping table at one end, which is used for connecting a cap or a drainage bag;

[0011] The outer wall of the internal drainage area and the shaping area is provided with a side hole penetrating into the inner cavity;

[0012] The rear end of the side hole of the internal drainage area is provided with a marker point between the narrow segment covering area;

[0013] The shaping area is naturally curled into a loop, and the hard sleeve can straighten the shaping area;

[0014] The narrow segment covering area is distributed between the internal drainage area and the shaping area;

[0015] The fixed pull wire comprises a fixed sheet and a pull wire, and the tail end of the pull wire is connected with the fixed sheet;

[0016] The external drainage area of the drainage catheter is provided with a mounting hole, and the thread end of the other end of the fixed pull wire passes through the mounting hole from the outside of the drainage catheter into the inner cavity of the drainage catheter, and then passes out of the drainage catheter from the hole at the most front end of the shaping area, and then extends along the outer wall of the drainage catheter to be connected and fixed with the hole at the last end of the shaping area;

[0017] The hard sleeve is composed of a conical joint and a sleeve core, and the sleeve core is inserted into the conical joint at one end;

[0018] The hard sleeve is used in cooperation with the drainage catheter, the hard sleeve is pulled to the end of the internal drainage area after being inserted from the external drainage area, and the curled part of the shaping area is straightened.

[0019] The preferred scheme of the biliary tract internal and external drainage device is that the external surface of the drainage catheter is smooth and has no processing defects, the tail of the tube body of the external drainage area is connected with a cap, and the outer wall is provided with anti-skid lines.

[0020] The preferred scheme of the biliary tract internal and external drainage device is that the size of the drainage catheter is designed according to clinical application.

[0021] The preferred scheme of the biliary tract internal and external drainage device is that the marker point is provided with a titanium alloy coating for ultrasonic imaging and X-ray imaging.

[0022] The preferred scheme of the biliary tract internal and external drainage device is that the narrow section covering area can cover the narrow section of the biliary tract.

[0023] The preferred scheme of the biliary tract internal and external drainage device is that the material of the hard sleeve is stainless steel, the outer diameter of the sleeve core is greater than 0.06 mm, and after the hard sleeve is completely inserted into the drainage catheter, the spiral at the end of the external drainage area of the drainage catheter can be opened.

[0024] The material of the drainage catheter is polyurethane, and the hardness of the internal drainage area, the narrow section covering area and the external drainage area is greater than that of the shaping area.

[0025] The preferred scheme of the biliary tract internal and external drainage device is that the scale is arranged at a place without side holes and is marked along the length of the drainage catheter.

[0026] The procedure for using a bile duct drainage device: The patient lies supine with their right hand covering their head. The area is disinfected and draped. Under ultrasound guidance, the target bile duct is located and the puncture point is positioned. The puncture point is locally anesthetized, and the skin is incised with a blade. The puncture needle is assembled, and under ultrasound guidance, it is inserted sequentially into the skin, liver, and target bile duct at the puncture point. The patient is instructed to hold their breath at each step of the insertion. After entering the target bile duct, the patient is instructed to breathe slowly. While gently unscrewing the needle core, the needle sheath is advanced along the bile duct. When the sheath has penetrated 2-3 cm into the bile duct, a cool, pale yellow liquid is observed flowing from the sheath. Contrast agent is injected into the sheath. Under DSA (Digital Subtraction Angiography) equipment, the intrahepatic bile ducts are visualized, indicating successful puncture. A guidewire is inserted through the sheath, continuously rotated and redirected to guide it through the obstruction or stenosis into the distal bile duct or duodenum. The needle sheath is then withdrawn, and the channel is dilated with a dilator. The biliary drainage device of this technique is then passed through the obstruction or stenosis along with the guidewire, ensuring the side hole at the tip of the internal drainage area of ​​the catheter is positioned below the obstruction or stenosis. A marker is used for positioning, and the rigid cannula is gradually removed. When it is withdrawn between the stenosis coverage area and the shaping area, the fixing suture at the end of the external drainage area of ​​the drainage catheter is pulled, and the external drainage catheter is further inserted into the body along the rigid cannula, advancing it 4 cm inward to create a loop in the shaping area. The rigid cannula is then continuously withdrawn until completely removed. After bile flows smoothly from the catheter, contrast agent is injected. A second contrast imaging reveals good visualization of the intrahepatic bile ducts, good loop formation in the middle of the catheter, and the side hole at the tip of the internal drainage area of ​​the drainage catheter is well positioned within the common bile duct. The end of the drainage catheter is capped to achieve internal drainage. If the internal drainage is ineffective, a drainage bag is attached to the end of the external drainage area and fixed externally. After the biliary tract puncture and drainage are completed, the patient is pushed to the ward in a wheelchair.

[0027] Beneficial effects

[0028] This invention enables internal and external drainage and achieves local treatment of tumors. In addition, it provides more stable bile duct fixation, reduces the risk of infection, improves patient comfort, and is easy to operate and use by medical staff.

[0029] The drainage catheter used in this technical solution is made of a biocompatible material and can achieve both internal and external drainage. Its central section features a specially designed plastic loop for fixation within the bile duct. Multiple side holes are provided in the middle and tip of the drainage tube to promote adequate drainage and reduce the risk of infection. Attached Figure Description

[0030] Figure 1 A schematic diagram of a biliary drainage device (internal or external);

[0031] Figure 2 This is a schematic diagram of the drainage catheter structure;

[0032] Figure 3 This is a schematic diagram of a rigid sleeve;

[0033] Figure 4 This is a schematic diagram of the loop structure of an internal and external biliary drainage device after it enters the biliary tract.

[0034] In the diagram, 1 is the drainage tube, 2 is the fixing wire, 3 is the rigid sheath, 4 is the internal drainage area, 5 is the narrow segment coverage area, 6 is the shaping area, 7 is the external drainage area, 8 is the side hole, 9 is the marker point, 10 is the fixing piece, 11 is the wire, 12 is the mounting hole, 13 is the conical connector, and 14 is the sheath core. Detailed Implementation

[0035] like Figures 1-4 The illustrated bile duct drainage device includes a drainage catheter 1, a fixing wire 2, and a rigid sleeve 3;

[0036] The drainage catheter 1 consists of an inner drainage area 4, a narrow section covering area 5, a shaping area 6, and an outer drainage area 7, and has a hollow internal structure.

[0037] One end of the inner drainage area 4 is designed as a cylindrical cone;

[0038] One end of the external drainage area 7 is provided with a locking platform for connecting the cap;

[0039] The outer walls of the inner drainage area 4 and the shaping area 6 are provided with side holes 8 that penetrate into the inner cavity;

[0040] A marker point 9 is provided between the rear end of the side hole 8 of the inner drainage area 4 and the narrow section coverage area 5;

[0041] The shaping area 6 is naturally curled into a loop, and can be straightened by the rigid sleeve 3;

[0042] The narrow segment coverage area 5 is distributed between the inner drainage area 4 and the shaping area 6.

[0043] The fixing wire 2 includes a fixing piece 10 and a wire 11, with the tail end of the wire 11 connected to the fixing piece 10;

[0044] The drainage area 7 of the drainage conduit 1 is provided with a mounting hole 12. The end of the other end of the fixing wire 2 enters the inner cavity of the drainage conduit 1 through the mounting hole 12 from the outside of the drainage conduit 1, passes out of the drainage conduit 1 through the side hole 8 at the front end of the shaping area 6, and extends along the outer wall of the drainage conduit 1 to connect and fix with the side hole 8 at the rear end of the shaping area 6.

[0045] The rigid sleeve 3 is composed of a conical joint 13 and a sleeve core 14, with one end of the sleeve core 14 inserted into the conical joint 13;

[0046] The rigid sheath 3 is used in conjunction with the drainage catheter 1. After the rigid sheath 3 is inserted into the outer drainage area 7, it is pulled to the end of the inner drainage area 4, and the curled part of its shaping area 6 is straightened.

[0047] The outer surface of the drainage catheter 1 is smooth and has no processing defects, and the tail of the tube body of the outer drainage area 7 is connected with a cap, and the outer wall is provided with anti-skid lines.

[0048] The size of the drainage catheter 1 is designed according to clinical application.

[0049] The marker point 9 is provided with a titanium alloy coating for ultrasonic imaging and X-ray imaging.

[0050] The material of the hard sleeve 3 is stainless steel, the outer diameter of the sleeve core is greater than 0.06 mm, and after all the hard sleeve 3 is inserted into the drainage catheter 1, the end spiral of the outer drainage area 7 of the drainage catheter 1 can be opened.

[0051] The material of the drainage catheter 1 is polyurethane, and the hardness of the inner drainage area 4, the narrow section covering area 5 and part of the outer drainage area 7 is greater than that of the shaping area 6.

[0052] The scale is set at a place without side holes and is marked along the length of the drainage catheter 1.

[0053] The operation process of the biliary tract internal and external drainage device is as follows: the patient is in a supine position, the right hand is wrapped, and the patient is sterilized and laid with a towel. The target biliary tract in the biliary tract is found and the puncture point is positioned under the guidance of ultrasound, the puncture point is anesthetized and the skin is broken by a blade, and a combined puncture needle is used. Under the guidance of ultrasound, the puncture needle enters the skin, liver and target bile duct in the puncture point in turn; the patient is asked to hold his breath and then the needle is inserted at each step. After entering the target biliary tract, the patient is asked to breathe slowly, the needle core of the puncture needle is rotated out gently, and the needle sheath is sent into the biliary tract along the biliary tract. When the needle sheath enters the biliary tract by 2-3 cm, the light yellow cool liquid in the needle sheath can be seen, the contrast agent is injected into the sheath, the intrahepatic bile duct is developed under the DSA device, and the puncture is successful. The guide wire is sent into the sheath, and the guide wire is continuously rotated and changed in direction, so that the guide wire passes through the obstruction end or the narrow section and enters the distal bile duct or the duodenum. The needle sheath is withdrawn, and the drainage tube is expanded after the passage is expanded by the expansion tube. The biliary tract internal and external drainage device of the technical solution is passed through the obstruction end or the narrow section along the guide wire, so that the head end side hole of the internal drainage area of the catheter is located below the obstruction end or the narrow section, the marker is positioned, the hard sleeve is gradually taken out, and when it is taken out to the narrow section covering area and the shaping area, the fixed pull wire at the tail end of the external drainage area of the drainage catheter is pulled, and the external end of the drainage catheter is sent into the body along the hard sleeve, so that the drainage catheter is sent into the body by 4 cm, and the plastic area is formed into a coil. Then the hard sleeve is continuously withdrawn until it is completely withdrawn. After the bile is smoothly discharged from the catheter, the contrast agent is injected, and the intrahepatic bile duct is developed well in the second imaging, the guide wire is well positioned in the common bile duct, the tail cap of the drainage catheter is realized, the internal drainage is realized, if the internal drainage effect is not good, the drainage bag is connected to the tail end of the external drainage area in the later period and is fixed externally, the biliary tract puncture drainage is completed, and the patient is wheeled to the ward.

Claims

1. An internal and external biliary drainage device, characterized in that: The drainage catheter, the fixed pull wire and the hard sleeve pipe are included. The drainage catheter is composed of an inner drainage area, a narrow segment covering area, a shaping area and an outer drainage area. The inner drainage area is designed as a cylindrical cone at one end. The outer drainage area is provided with a clamping platform at one end for connecting a cap or a drainage bag. The outer wall of the inner drainage area and the shaping area is provided with a side hole penetrating into the inner cavity. The side hole of the inner drainage area is provided with a marker point between the rear end and the narrow segment covering area. The shaping area is naturally curled into a loop, and the hard sleeve pipe can straighten the shaping area. The narrow segment covering area is distributed between the inner drainage area and the shaping area. The fixed pull wire includes a fixed sheet and a pull wire, and the tail end of the pull wire is connected with the fixed sheet. The outer drainage area of the drainage catheter is provided with a mounting hole, and the thread end of the other end of the fixed pull wire enters the inner cavity of the drainage catheter from the outside of the drainage catheter through the mounting hole, and then passes out of the drainage catheter from the hole at the front end of the shaping area, and then extends along the outer wall of the drainage catheter and is connected and fixed with the hole at the rear end of the shaping area. The hard sleeve pipe is composed of a conical joint and a sleeve core, and the sleeve core is inserted into the conical joint at one end. The hard sleeve pipe is used in cooperation with the drainage catheter, the hard sleeve pipe is pulled to the end of the inner drainage area after being inserted from the outer drainage area, and the curled part of the shaping area is straightened.

2. An internal and external biliary drainage device as claimed in claim 1, characterized in that: The outer surface of the drainage catheter is smooth and has no processing defects, the tail of the tube body of the outer drainage area is connected with the cap, and the outer wall is provided with anti-skid lines.

3. An internal and external biliary drainage device as in claim 1, wherein: The size of the drainage catheter is designed according to clinical application.

4. An internal and external biliary drainage device as in claim 1, wherein: The marker point is provided with a titanium alloy coating for ultrasonic imaging and X-ray imaging.

5. An internal and external biliary drainage device as in claim 1, wherein: The narrow segment covering area can cover the narrow segment of the bile duct.

6. An internal and external biliary drainage device as in claim 1, wherein: The material of the hard sleeve pipe is stainless steel, the outer diameter of the sleeve core is greater than 0.06 mm, and after being fully inserted into the drainage catheter, the spiral at the end of the outer drainage area of the drainage catheter can be opened. The material of the drainage catheter is polyurethane, and the hardness of the inner drainage area, the narrow segment covering area and the outer drainage area is greater than that of the shaping area.

7. An internal and external biliary drainage device as in claim 1, wherein: The scale is set at a place without a side hole and is marked along the length of the drainage catheter.