Drainage catheter for biliary tract and biliary tract negative pressure drainage system

Abstract

The invention discloses a drainage catheter for a biliary tract and a biliary tract negative pressure drainage system. The biliary tract negative pressure drainage system comprises a negative pressure instrument, a liquid storage device, a drainage catheter and a catheter fixator. Wherein the negative pressure instrument is used for providing negative pressure and carrying out pressure detection. The liquid storage device is connected with the negative pressure instrument, so that negative pressure is formed in the liquid storage device through the negative pressure instrument. The drainage catheter comprises a connector, a catheter body and a pull wire. The connector is used for being connected with a liquid storage device and used for conveying liquid into the liquid storage device. The tube body is connected with the connector and used for drainage of liquid. The stay wire is arranged in the tube body in a penetrating mode so as to pull the far end of the tube body to form a pigtail-shaped circle. The catheter fixator is connected with the catheter body of the drainage catheter and used for fixing the catheter body to the skin surface near the biliary tract. When the far end of the catheter body forms a pigtail-shaped circle, the center line of the drainage catheter and the center line of the drainage section are located in the same plane, so that the drainage tip does not protrude, and the safety of biliary tract drainage is effectively improved.

Description

Technical Field

[0001] The invention relates to a drainage catheter for a bile duct and also to a corresponding bile duct negative pressure drainage system, belonging to the technical field of medical devices. Background Art

[0002] Patients with biliary obstruction may experience jaundice and other inflammatory problems due to the inability to excrete bile. In order to speed up the body's recovery, short-term external bile drainage is often required, followed by follow-up treatment. The following are two common methods of bile drainage:

[0003] 1. Drainage bag: Use percutaneous transhepatic choledochal drainage (PTCD) for bile drainage. The drainage bag is simple in design and mainly includes liquid inlet and outlet, storage bag and anti-reflux device. It uses the internal pressure of the bile duct to drain the excess bile by itself.

[0004] 2. Negative pressure drainage bottle: It is mainly composed of bottle body, check valve, one-way valve, bottle stopper, bottle cap, catheter, joint, sheath, hanging belt, stainless steel pin. The key to its design is to use the check valve to prevent the entry of external air and the one-way valve to prevent the backflow of bile. The principle of the one-way valve is similar to the anti-reflux device of the drainage bag.

[0005] Regardless of the drainage method used, a drainage catheter is required. Currently, most bile duct drainage on the market uses a pull-wire pigtail drainage catheter. After the catheter enters the bile duct, the pull wire needs to be tightened to curl the head into a pigtail shape to prevent the drainage catheter from being pulled out and to facilitate bile outflow. However, existing drainage catheters have the problem of protruding tips. Due to the high hardness of the tip, it may cause scratches on the inner wall of the bile duct and cause wound infection at the percutaneous puncture site.

[0006] In addition, the surface of drainage catheters on the market usually uses a hydrophilic coating process to reduce friction with human tissues, improve the convenience of operation and patient comfort. The inside of the catheter is also covered with a hydrophilic coating, which increases the hydrophilicity and may cause bile to be easily adsorbed on the inner wall of the catheter, and friction is generated between the liquid and the tube wall, and between the liquid and the liquid, which slows the flow of bile and affects the drainage effect. At the same time, bile attached to the inner wall of the catheter may breed bacteria and cause bile tract infection. Summary of the invention

[0007] The primary technical problem to be solved by the present invention is to provide a drainage catheter for the bile duct.

[0008] Another technical problem to be solved by the present invention is to provide a biliary negative pressure drainage system including the above-mentioned drainage catheter.

[0009] In order to achieve the above technical objectives, the present invention adopts the following technical solutions:

[0010] According to a first aspect of an embodiment of the present invention, there is provided a drainage catheter for a bile duct, comprising:

[0011] A connector, used for connecting with a liquid storage device;

[0012] A tube body, the proximal end of which is connected to the joint, and the distal end of which has a drainage section; wherein a plurality of drainage holes are provided on the outer wall of the drainage section, and the end of the drainage section has a drainage tip for inserting into the bile duct;

[0013] A pull wire is inserted into the tube body, and a pull wire hole is opened on the outer wall of the tube body, one end of the pull wire is buried in the drainage tip, and the other end is inserted into the tube body and led out from the joint;

[0014] Among them, pulling the pull wire can make the drainage tip drive the drainage section to bend from a horizontal state into a pigtail-shaped circle; and the center line of the drainage tip and the center line of the drainage section are located in the same plane, and the multiple drainage holes and the drainage tip are all located on the inner side of the pigtail-shaped circle.

[0015] Preferably, the length of the drainage tip is L1, the outer diameter of the drainage tip is d2, the outer diameter of the tube body is d1, the diameter of the pigtail circle is D1, and the gap between the outer wall of the drainage tip and the inner wall of the pigtail circle is g, then:

[0016]

[0017] Among them, the value of d1 is determined according to the specifications of the drainage catheter; the value of d2 is determined according to the specifications of the guide wire; L1 and D1 are both unknown quantities and are positively correlated.

[0018] Preferably, the outer side of the tube is coated with a hydrophilic coating to reduce friction with human tissue;

[0019] The inner side of the tube is coated with a hydrophobic coating to prevent liquid from adhering to the inner wall of the tube.

[0020] Preferably, a fixing plate is further provided on the outer wall of the tube body, and the fixing plate is used to be connected to a catheter holder to limit the axial movement of the tube body.

[0021] According to a second aspect of an embodiment of the present invention, there is provided a biliary negative pressure drainage system, comprising:

[0022] Negative pressure instrument, used to provide negative pressure and perform pressure detection;

[0023] A liquid storage device connected to the negative pressure meter so as to form a negative pressure inside the liquid storage device through the negative pressure meter;

[0024] The above-mentioned drainage catheter, the connector is connected to the liquid storage device, and the drainage tip is used for percutaneous transhepatic biliary drainage to be inserted into the bile duct;

[0025] A catheter fixer is connected to the tube body and is used to fix the tube body to the skin surface near the bile duct.

[0026] Preferably, the catheter holder comprises:

[0027] Dressings, which are applied to the skin near the bile duct;

[0028] The catheter fixing seat comprises a base and an upper cover, wherein the base is fixed to the surface of the dressing, and a limiting hole is provided on the base; the upper cover is reversibly connected to the top of the base, and a limiting column is extended toward the base from a side of the upper cover facing the base;

[0029] Among them, a fixing plate is also provided on the outer wall of the tube body, and a fixing hole is opened on the fixing plate; the fixing plate is used to be placed on the base, and the fixing hole is aligned with the limiting hole so that the limiting column can pass through the fixing hole and be inserted into the limiting hole.

[0030] Preferably, the catheter holder further comprises:

[0031] A connecting tube, wherein the first end of the connecting tube is connected to the dressing, and the dressing is provided with an opening portion connected to the connecting tube; the second end of the connecting tube is connected to the negative pressure meter so that a negative pressure area is formed between the dressing and the skin surface through the negative pressure meter.

[0032] Preferably, the liquid storage device comprises:

[0033] A housing having a closed hollow inner cavity;

[0034] An air outlet pipe, a first end of which is communicated with the housing, and a second end of which is connected with the negative pressure instrument;

[0035] A liquid inlet pipe, a first end of which is communicated with the housing, and a second end of which is connected with the joint;

[0036] a water blocking filter, disposed in the hollow inner cavity and connected to the first end of the gas outlet pipe, for passing gas and blocking liquid;

[0037] A backflow prevention member, disposed in the hollow inner cavity and connected to the first end of the liquid inlet pipe, for preventing the liquid from backflowing back into the liquid inlet pipe;

[0038] The liquid absorption part is arranged in the hollow inner cavity and is used for absorbing liquid.

[0039] Preferably, the backflow prevention member comprises an inner film layer and an outer film layer, the inner film layer is located on the inner side of the outer film layer, and the tops of the inner film layer and the outer film layer are sealed simultaneously by a hot pressing process, the sides are sealed separately, and the bottom is open to form a liquid inlet channel in the inner film layer; the first end of the liquid inlet pipe is connected to the liquid inlet channel;

[0040] Wherein, under negative pressure, liquid flows from the liquid inlet pipe into the liquid inlet channel and flows toward the liquid suction part; under normal pressure, the inner film layer and the outer film layer are automatically closed to block the liquid inlet channel.

[0041] Preferably, the liquid inlet channel is a wide-mouth single channel or narrow-mouth multiple channels.

[0042] Compared with the prior art, the present invention has the following beneficial effects:

[0043] (1) Through structural analysis of the drainage catheter, the relationship formula between the cone length L1, the outer diameter of the drainage catheter d1, the diameter of the pigtail circle D1 and the outer diameter of the cone tip d2 was obtained: As a result, the drainage catheter can have a pigtail-shaped head with a non-protruding tip, thereby avoiding the risk of damaging the bile duct and improving the safety of biliary drainage.

[0044] (2) By applying a hydrophobic coating on the inner side of the tube, air is created between the liquid and the tube wall, making it difficult for the liquid to adhere to the inside of the tube wall. This results in almost no friction between the liquid and the tube wall, which speeds up the drainage process, keeps the catheter unobstructed, and prevents the liquid from adhering to the inner wall of the catheter, thereby preventing bacteria from growing and reducing the risk of bile duct infection.

[0045] (3) A fixing plate is also provided on the outer wall of the tube body. The fixing plate is connected and cooperated with the catheter holder to limit the axial movement of the tube body and prevent the tube body from shifting.

[0046] (4) The catheter holder is provided with a connecting tube. By using the connecting tube in conjunction with the negative pressure meter, a negative pressure area can be formed between the dressing and the skin surface. While bile is drained, negative pressure treatment of the wound can also be performed to promote wound healing and effectively prevent the occurrence of infection.

[0047] The bile duct drainage tube uses a single traction line to achieve the function of pigtail curling. At present, the anti-displacement of the bile duct drainage tube body is achieved by pulling the lead wire at the head end to achieve the curling of the pigtail. The current traction line path is formed by forming a loop in the drainage tube, which greatly hinders the drainage efficiency and causes blockage in the tube. The single lead design can save space and improve drainage efficiency.

[0048] (5) The negative pressure instrument can set the pressure value (for example: 3kPa) at which the negative pressure pump is turned on to actively drain the bile; it can also provide a negative pressure of about 20kPa for continuous or intermittent drainage until the pressure in the bile duct drops to a certain value. The air pressure sensor detects and sends a signal, and the instrument stops working. As a result, the bile duct negative pressure drainage system can safely and comfortably perform automatic drainage, improve drainage efficiency, shorten drainage time, and speed up patient recovery, thereby preparing for the next step of treatment.

[0049] The negative pressure meter can realize positive and negative pressure functions. Bile is essential for human physiological functions and helps digestion and physiological activities. Bile deficiency leads to loss of human physiological functions. When the drainage reaches a certain stage, the bile returns to normal state. When the bile duct is unobstructed, close the wound negative pressure valve, open the branch channel, and the negative pressure meter can convert it into positive pressure, press the bile in the reservoir into the bile duct through the branch one-way channel drainage tube, and discharge it through the intestine. It replaces the current effect of drinking bile directly or implanting an internal drainage tube.

[0050] (6) With the present invention, patients can get out of bed and move freely, and can arrange their own activities such as going to the toilet and eating without having to stay in bed for a long time, thereby improving the patient's user experience. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] Figure 1 A schematic structural diagram of a drainage catheter for a bile duct provided in a first embodiment of the present invention;

[0052] Figure 2 This is a schematic diagram of the intermediate process of the drainage section bending into a pigtail-shaped circle in the first embodiment of the present invention;

[0053] Figure 2A A schematic cross-sectional structure diagram of a drainage catheter for a bile duct provided in a first embodiment of the present invention;

[0054] Figure 2B A schematic structural diagram of another bile duct drainage catheter provided in the first embodiment of the present invention;

[0055] Figure 3 This is a schematic diagram of the final result of the drainage section being bent into a pigtail-shaped circle in the first embodiment of the present invention;

[0056] Figure 4 This is a schematic diagram of the relationship between various parameters of the tube body and the drainage tip in the first embodiment of the present invention;

[0057] Figure 5 A schematic structural diagram of a bile duct negative pressure drainage system provided in accordance with a second embodiment of the present invention;

[0058] Figure 6 This is a schematic structural diagram of a negative pressure instrument in a second embodiment of the present invention;

[0059] Figure 7 This is a schematic structural diagram of a liquid storage device in a second embodiment of the present invention;

[0060] Figure 8 This is a schematic structural diagram of a backflow prevention member in a second embodiment of the present invention;

[0061] Fig. 9 This is another structural schematic diagram of the backflow prevention member in the second embodiment of the present invention;

[0062] Fig.10 It is a structural schematic diagram of a catheter fixer in a second embodiment of the present invention;

[0063] Fig.11 FIG. 1 is a diagram showing the matching structure of the catheter holder and the tube body in the second embodiment of the present invention. DETAILED DESCRIPTION

[0064] The technical content of the present invention is described in detail below with reference to the accompanying drawings and specific embodiments.

[0065] The current drainage catheter has a problem that the hardness of the tip is high, which may cause scratches on the inner wall of the bile duct, and at the same time, wound infection may occur at the percutaneous puncture site. Through analysis, the inventor determined that the problem of protrusion at the tip of the catheter is related to the outer diameter of the catheter, the length / diameter of the cone at the tip, the diameter of the pigtail-shaped circle, and the position of the pull-wire hole. The relationship between each parameter needs to be clarified to avoid the occurrence of protrusion and damage to the bile duct during the design and development process. Based on this, an embodiment of the present invention provides a drainage catheter for the bile duct, which improves the safety of bile duct drainage by optimizing the structure of the drainage catheter.

[0066] In addition, the current drainage catheter holder may cause displacement of the drainage catheter due to the limited locking force, thus requiring re-insertion of the catheter. The inventor improves the structure of the catheter holder, which not only improves the stability of the guide tube fixation, but also achieves the effect of negative pressure therapy for wounds.

[0067] On this basis, the embodiment of the present invention also provides a bile duct negative pressure drainage system, which ensures that the drainage catheter is firmly fixed while ensuring the smoothness of drainage, and can provide active, gentle, and stable negative pressure, thereby increasing the drainage speed, accelerating the patient's recovery speed, and facilitating subsequent treatment. In addition, it can also detect and monitor the conditions for starting and stopping bile drainage, achieving physiological drainage that conforms to the human body, and making drainage intelligent and precise.

[0068] First embodiment

[0069] like Figure 1As shown, the first embodiment of the present invention provides a drainage catheter for the bile duct, including a connector 1, a tube body 2 and a pull wire 3. The connector 1 is used to connect to a liquid storage device, and is used to transport liquid (bile in this embodiment) into the liquid storage device. The tube body 2 is connected to the connector 1 and is used for drainage of liquid. The pull wire 3 is passed through the tube body 2 to pull the distal end of the tube body 2 to form a pigtail-shaped circle. In this embodiment, the proximal end of the tube body 2 refers to the end close to the operator (for example: doctor); the distal end of the tube body 2 refers to the end close to the patient, which is used to be inserted into the patient's bile duct, so as to drain the bile from the distal end of the tube body 2 to the connector 1, and transport it to the liquid storage device.

[0070] like Figure 1 As shown, in this embodiment, the proximal end of the tube body 2 is connected to the connector 1, and the distal end of the tube body 2 has a drainage section 21. A plurality of drainage holes 211 are provided on the outer wall of the drainage section 21, and the end of the drainage section 21 has a drainage tip 22 for inserting into the bile duct. In this embodiment, the drainage section 21 refers to a section of the tube body used to form a pigtail-shaped circle, and the drainage section 21 does not include the drainage tip 22.

[0071] like Figure 2 and Figure 3 As shown, in this embodiment, the pull wire 3 is inserted into the tube body 2, a pull wire hole 23a is provided on the outer wall of the tube body 2, and a wire outlet 23b is provided on the drainage tip 22. Figure 2A As shown, the pull wire 3 is embedded in the drainage tip 22 by injection molding or other processes, and is led out through the outlet 23b, and then penetrates into the tube body 2 from the pull wire hole 23a, and is led out from the connector 1, so that the doctor can manually control the tightening. Therefore, when the pull wire 3 is pulled, the drainage tip 22 can drive the drainage section 21 to bend from a horizontal state into a pigtail-shaped circle (i.e. Figure 3 Moreover, when the drainage section 21 is bent into a pigtail-shaped circle, the center line of the drainage tip 22 is located in the same plane as the center line of the drainage section 21, and the plurality of drainage holes 211 and the drainage tip 22 are located on the inner side of the pigtail-shaped circle, thereby avoiding the risk of the drainage tip 22 being exposed and scratching the inner wall of the bile duct.

[0072] It can be understood that, in this embodiment, the pull wire 3 does not form a loop in the tube body 2, thereby reducing the obstruction of the pull wire 3 to the fluid, which is beneficial to increasing the flow rate of the liquid on the one hand, and can save costs on the other hand.

[0073] In addition, if Figure 2BAs shown, in another embodiment, the pull wire 3 can be directly omitted and a straight tube body can be used to further improve the flow rate of the liquid. At this time, since the drainage tip 22 of the tube body 2 can no longer form a pigtail-shaped circle, in order to prevent the bile duct from contracting and causing the drainage hole to be blocked, it is necessary to open holes in an array around the outside of the tube body 2 to ensure the stability of bile drainage and the strength of the tube body.

[0074] In the above embodiment, in order to enable the distal end of the tube body 2 to achieve the following Figure 3 For the condition shown, it is necessary to clarify the relationship between the outer diameter of the catheter, the length / diameter of the tip cone, the diameter of the pigtail circle and the position of the pull wire hole.

[0075] Specifically, refer to Figure 4 As shown, the relationship between the parameters is as follows:

[0076] The cone length of the drainage tip 22 is: L1; the outer diameter of the tube body 2 is d1; the diameter of the pigtail circle is D1; ​​the outer diameter of the cone tip of the drainage tip 22 is: d2; the cone is required not to touch the tube body, otherwise it will protrude, that is, the gap g is required to be ≥ 0. Since the outer diameter of the cone tip d2 is determined by the specification of the guide wire (0.025 / 0.038 inches), d2 is a fixed value (the fixed value is assumed to be 1.6mm), and the outer diameter d1 of the drainage catheter is a fixed specification, and the commonly used specifications are 6F / 8F / 10F / 12F, etc.

[0077] According to the calculation, we can get:

[0078]

[0079] When d2 is a constant value of 1.6 mm, we get:

[0080] When the catheter is 6F, that is, d1 = 2, we get:

[0081] When the catheter is 8F, that is, d1 = 2.7, we get:

[0082] When the catheter is 10F, that is, d1 = 3.3, we get:

[0083] When the catheter is 12F, that is, d1 = 4.0, we get:

[0084] In summary, when the tip diameter is set to a fixed value of 1.6 mm, for drainage catheters with different outer diameters, in order to avoid tip protrusion, the cone length L1 and the pigtail circle diameter D1 need to follow a certain parameter relationship, that is, a positive correlation relationship. Therefore, as long as any one of the cone length L1 and the pigtail circle diameter D1 is known, the value of the other parameter can be deduced.

[0085] Of course, this conclusion is based on the design discussion that when the drainage section 21 is bent into a pigtail-shaped circle, the drainage tip 22 is in a horizontal state. There are two other situations: First, if the drainage tip 22 is curled toward the inside of the circle, it will be more conducive to avoiding contact with the tube body; second, if the drainage tip 22 is curled outside the circle, it will be easier to contact the tube body, causing the tip to protrude. The specific design can be adaptively adjusted according to the actual situation, and it is only necessary to ensure that the center line of the drainage tip 22 is located in the plane where the center line of the pigtail-shaped circle is located.

[0086] In addition, in the above embodiment, preferably, the outer side of the tube body 2 is coated with a hydrophilic coating to reduce the friction between the tube wall and the human tissue, making the operation smoother. In addition, the inner side of the tube body 2 is coated with a hydrophobic coating to prevent the liquid from adhering to the inner wall of the tube body 2. It is understandable that in the prior art, by coating the surface of the drainage catheter with a hydrophilic coating as a whole, bile is easily adsorbed on the inner wall of the catheter, and there is friction between the liquid and the tube wall, and between the liquid and the liquid, which will cause the bile to flow slowly and affect the drainage effect; at the same time, the bile attached to the inner wall of the catheter will breed bacteria, leading to the occurrence of bile tract infection. Therefore, in this embodiment, by coating the outer side of the tube body 2 with a hydrophilic coating and the inner side with a hydrophobic coating, air is present between the liquid and the tube wall, and the liquid is not easy to adhere to the inside of the tube wall, so that there is almost no friction between the liquid and the tube wall, which will speed up the drainage speed, the catheter is unobstructed and not blocked, and the liquid will not adhere to the inner wall of the catheter, will not breed bacteria, and reduce the risk of bile tract infection.

[0087] like Figure 1 As shown, in the above embodiment, preferably, a fixing sheet 24 is further provided on the outer wall of the tube body 2, and the fixing sheet 24 is used to connect with the catheter holder to limit the axial movement of the tube body 2. Specifically, the fixing sheet 24 is processed by pasting or secondary injection molding, and two fixing holes 241 are provided on the fixing sheet 24 (the number is not limited, and can be zero, two, three, four or more). Correspondingly, the catheter holder has a limiting column (described in detail below) matching the fixing hole 241, so that the limiting column and the fixing hole 241 are used to limit the axial position of the tube body 2 and improve the stability of the use of the tube body 2. It can be understood that if the fixing hole 241 is not provided on the fixing sheet 24, the friction between the fixing sheet 24 and the catheter holder can also prevent the axial movement of the tube body 2 to a certain extent.

[0088] Second embodiment

[0089] like Figure 5As shown, based on the above-mentioned first embodiment, the second embodiment of the present invention provides another biliary negative pressure drainage system, including a negative pressure meter 10, a liquid storage device 20, the drainage catheter 30 in the above-mentioned first embodiment, and a catheter holder 40. Among them, the negative pressure meter 10 is used to provide negative pressure and perform pressure detection. The liquid storage device 20 is connected to the negative pressure meter 10 so that negative pressure is formed inside the liquid storage device 20 through the negative pressure meter 10. The connector 1 of the drainage catheter 30 is connected to the liquid storage device 20, and the drainage tip 22 is used for percutaneous transhepatic biliary drainage to be inserted into the bile duct. The catheter holder 40 is used in conjunction with the tube body 2 to fix the tube body 2 to the skin surface near the bile duct.

[0090] Specifically, Figure 6 As shown, the negative pressure instrument 10 is composed of a housing 101, a switch button 102, an indicator light 103 and a negative pressure interface 104. In this embodiment, the switch button 102 is arranged on the housing 101, and is used to turn on and off the negative pressure instrument. There are three indicator lights 103, which include a power indicator light, a liquid storage indicator light and a power indicator light from left to right (not limited to this layout form). Among them, the power indicator light is used to indicate the power-on state of the negative pressure instrument, the liquid storage indicator light is used to indicate whether the liquid storage device 20 is full of liquid, and the circuit indicator light is used to indicate the remaining power state. There are two negative pressure interfaces 104 (or 3 or more) on the housing 101, one negative pressure interface 104 is connected to the liquid storage device 20 and the drainage catheter 30, and is used for bile negative pressure drainage; the other negative pressure interface 104 is used to connect the catheter holder 40, which is used to implement negative pressure treatment on the wound.

[0091] In addition, the negative pressure instrument 10 has components such as a control panel, an air pressure sensor, a negative pressure pump, and a one-way valve. When it is detected that the bile duct pressure increases to a certain value, the negative pressure pump starts to drain the bile; when the pressure in the passage reaches the negative pressure limit, the sensor sends a signal and the instrument stops working, thereby forming a feedback-start-feedback-stop cycle, achieving active drainage of human physiological bile, better comfort, and improved drainage efficiency. When the liquid storage device is full, the water-blocking filter is blocked, and the negative pressure inside the air outlet pipe increases. When it reaches the limit value, the indicator light comes on, prompting you to replace the liquid storage device. The one-way valve inside the negative pressure instrument 10 can prevent the negative pressure pump from malfunctioning and providing positive pressure to cause damage to the human body.

[0092] The normal bile duct pressure is about 2kPa. When the patient has bile duct obstruction, the bile duct pressure increases. The air pressure sensor in the instrument can detect the bile duct pressure. When it reaches the set value (such as 3kPa), the negative pressure pump starts to provide a negative pressure of about 20kPa, and drains continuously or intermittently until the bile duct pressure drops to a certain value. The air pressure sensor sends a signal after detection, and the instrument stops working. The instrument is automatic, worry-free, safe, and comfortable, which improves drainage efficiency, shortens drainage time, speeds up patient recovery, and prepares for the next step of treatment.

[0093] In another embodiment, the negative pressure meter 10 can provide positive pressure in addition to negative pressure. Under positive pressure, the pressure in the liquid storage device 20 increases, so that the liquid (for example, external bile) pre-stored in the liquid storage device is injected into the duodenum through the bile duct or stomach through the drainage catheter 30. That is, in this embodiment, the bile in the patient's body can be drained into the liquid storage device 20, and the pre-prepared external bile can be delivered to the patient's body, so that it can be applied to different medical scenarios according to the needs of the patient. Preferably, a display can also be provided on the negative pressure meter 10 to display the current pressure value, and the pressure can be adjusted through the control panel. In addition, based on the pressure detection result, an alarm can be set to warn of high pressure.

[0094] like Figure 7 As shown, in this embodiment, the liquid storage device 20 includes a housing 201 , an air outlet pipe 202 , a liquid inlet pipe 203 , a water blocking filter 204 , a backflow prevention member 205 and a liquid suction portion 206 .

[0095] The shell 201 is sealed, and processes such as threading or ultrasonic welding can be used to ensure that the shell 201 is airtight, so that a closed hollow cavity is formed inside the shell 201.

[0096] The first end of the air outlet pipe 202 is connected to the housing 201, and the second end is connected to the negative pressure instrument 10. When the negative pressure instrument 10 is started, the hollow inner cavity of the housing 201 is negatively sucked through the air outlet pipe 202, so that sufficient negative pressure can be generated in the housing 201.

[0097] The first end of the liquid inlet tube 203 is connected to the housing 201 , and the second end is connected to the connector 1 . When sufficient negative pressure is generated in the housing 201 , bile in the patient's body can be drained into the housing 201 through the liquid inlet tube 203 .

[0098] The water-blocking filter 204 is disposed in the hollow inner cavity of the housing 201 and is connected to the first end of the air outlet pipe 202. Specifically, the water-blocking filter 204 contains a microporous PP membrane, which is used to pass gas and block liquid to prevent liquid from entering the instrument from the air outlet pipe 202 and damaging the instrument. In addition, in this embodiment, the water-blocking filter 204 is located at the top of the hollow inner cavity. Once liquid enters the water-blocking filter 204, the water-blocking filter 204 will be blocked, so that it can be judged whether the liquid storage device is full.

[0099] In this embodiment, preferably, the microporous PP membrane has a preset porosity. Porosity refers to the ratio of the volume of all pores on the microporous PP membrane to the total volume of the filter membrane. The greater the porosity of the membrane, the greater the flow rate. The flow rate refers to the total amount of gas passing through the microporous PP membrane per unit time at a specific temperature and pressure.

[0100] It is understandable that the viscosity of the liquid (i.e., the viscosity of the bile) varies from patient to patient, and the porosity can be preset. Therefore, the gas flow rate in the housing 201 can be controlled by controlling the pressure, and then the flow rate of the bile can be controlled, so that the patient can drain the bile at a relatively stable flow rate, reduce the patient's discomfort, and improve the user experience. Specifically, the feedback control process of the flow rate can be realized by the flow detector in conjunction with the control system, which will not be elaborated here.

[0101] The backflow prevention member 205 is disposed in the hollow inner cavity of the housing 201 and connected to the first end of the liquid inlet pipe 203 to prevent the liquid from backflowing into the liquid inlet pipe. Figure 8 As shown, in this embodiment, the anti-backflow member 205 includes an inner film layer 2051 and an outer film layer 2052. The inner film layer 2051 is located on the inner side of the outer film layer 2052, and the inner film layer and the outer film layer are sealed at the same time by a hot pressing process, the side edges are sealed separately, and the bottom is open to form a liquid inlet channel 2053 in the inner film layer 2051, and the first end of the liquid inlet pipe 203 is connected to the liquid inlet channel 2053. Among them, under negative pressure, the liquid flows into the liquid inlet channel 2053 from the liquid inlet pipe 203 and flows to the liquid suction part 206; under normal pressure, the inner film layer 2051 and the outer film layer 2052 are automatically closed, and the surface tension of the liquid is used to increase the closure of the film to block the liquid inlet channel 2053 to prevent liquid reflux. In addition, in this embodiment, the inner film layer 2051 and the outer film layer 2052 will cut off the air in their respective channels from each other to prevent reflux caused by the flow of air, so that the sealing effect is better.

[0102] In addition, preferably, the liquid inlet channel 2053 can be a wide-mouth single channel (such as Figure 8 As shown), it can also be a narrow multi-channel (as shown Fig. 9 As shown in the figure, the wide-mouth single channel has a large flow rate and a fast flow rate, which improves the efficiency of liquid inlet. The narrow-mouth multi-channel is more human-compliant, has a slow liquid flow rate, is comfortable in the bile duct, and achieves non-sensory drainage. When using it specifically, you can make an adaptive choice according to the needs of the usage scenario.

[0103] The liquid absorption part 206 is arranged in the hollow inner cavity of the housing 201 for absorbing liquid. In the present embodiment, the liquid absorption part 206 is a liquid absorption cotton, and the material is a polymer water-absorbing resin, fluff pulp and non-woven fabric, which can effectively absorb and lock water. Specifically, in the present embodiment, the liquid absorption part 206 is U-shaped and placed in the housing 201, and the backflow prevention part 205 is placed exactly in the middle of 206, so that bile can flow directly to the liquid absorption part 206 and be absorbed as soon as possible.

[0104] Furthermore, preferably, a partition is further provided in the hollow inner cavity of the shell 201 to separate the liquid suction portion 206 from the backflow prevention member 205 , so as to prevent the expansion or contraction of the liquid suction portion 206 from affecting the flow of liquid in the backflow prevention member 205 .

[0105] like Fig.10 As shown, in this embodiment, the catheter holder 40 includes a dressing 401, a catheter holder 402, and a connecting tube 403. The dressing 401 is used to be attached to the skin surface near the bile duct, and the catheter holder 402 is fixed on the dressing 401 to fix the tube body 2. The connecting tube 403 is used to connect with the negative pressure instrument 10 to achieve negative pressure treatment of the wound.

[0106] Dressing 401 has multiple layers, including release paper, silicone layer, liquid-absorbing cotton and medical tape layer from bottom to top. It has the characteristics of gentle adhesion, easy removal, breathability and sealing.

[0107] like Fig.11 As shown, the catheter fixing seat 402 includes a base 4021 and an upper cover 4022. The base 4021 is fixed to the surface of the dressing 401, and a limiting hole 4023 is provided on the base 4021. The upper cover 4022 is reversibly connected to the top of the base 4021, and a limiting column 4024 extends toward the base from the side of the upper cover 4022 facing the base. When the drainage catheter 30 needs to be fixed, the upper cover 4022 is first opened; then, the fixing sheet 24 on the tube body 2 is placed on the base 4021, so that the fixing hole 241 is aligned with the limiting hole 4023; finally, the upper cover 4022 is buckled, so that the limiting column 4024 can pass through the fixing hole 241 and be inserted into the limiting hole 4023, thereby completely fixing the drainage catheter 30 and preventing the tube body 2 from shifting.

[0108] The first end of the connecting tube 403 is connected to the dressing 401, and the dressing 401 is provided with an opening portion connected to the connecting tube 403. In addition, the second end of the connecting tube 403 is connected to the negative pressure meter 10, so that a negative pressure area is formed between the dressing 401 and the skin surface through the negative pressure meter 10. Thus, while bile is drained, negative pressure treatment of the wound can also be performed, promoting wound healing and effectively preventing the occurrence of infection. In addition, the wound can be flushed with a syringe first, and then negative pressure treatment can be performed.

[0109] In summary, the bile duct drainage catheter and bile duct negative pressure drainage system provided by the embodiments of the present invention have the following beneficial effects:

[0110] (1) Through structural analysis of the drainage catheter, the relationship formula between the cone length L1, the outer diameter of the drainage catheter d1, the diameter of the pigtail circle D1 and the outer diameter of the cone tip d2 was obtained: As a result, the drainage catheter can have a pigtail-shaped head with a non-protruding tip, thereby avoiding the risk of damaging the bile duct and improving the safety of biliary drainage.

[0111] (2) By coating the outer side of the tube body 2 with a hydrophilic coating and the inner side with a hydrophobic coating, air is created between the liquid and the tube wall, and the liquid is not easily attached to the inside of the tube wall, so that there is almost no friction between the liquid and the tube wall, which speeds up the drainage process, keeps the catheter unobstructed, and prevents the liquid from adhering to the inner wall of the catheter, thereby preventing bacteria from growing and reducing the risk of bile duct infection.

[0112] (3) A fixing plate 24 is also provided on the outer wall of the tube body 2. The fixing plate 24 is connected and cooperated with the catheter holder 40 to limit the axial movement of the tube body 2 and prevent the tube body 2 from shifting.

[0113] (4) The catheter holder 40 is provided with a connecting tube 403. By using the connecting tube 403 in conjunction with the negative pressure meter 10, a negative pressure area can be formed between the dressing 401 and the skin surface. While bile is drained, negative pressure treatment of the wound can also be performed to promote wound healing and effectively prevent the occurrence of infection.

[0114] (5) The negative pressure instrument 10 can set the pressure value (for example: 3kPa) for the negative pressure pump to be turned on to actively drain the bile; it can also provide a negative pressure of about 20kPa for continuous or intermittent drainage until the pressure in the bile duct drops to a certain value, and the air pressure sensor sends a signal after detection, and the instrument stops working. As a result, the bile duct negative pressure drainage system can safely and comfortably perform automatic drainage, improve drainage efficiency, shorten drainage time, and speed up patient recovery, thereby preparing for the next step of treatment.

[0115] (6) With the present invention, patients can get out of bed and move freely, and can arrange their own activities such as going to the toilet and eating without having to stay in bed for a long time, thereby improving the patient's user experience.

[0116] It should be noted that the above embodiments are only examples, and the technical solutions of the various embodiments can be combined, all within the protection scope of the present invention.

[0117] It should be understood that the terms "upper", "lower", "horizontal", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0118] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0119] The above is a detailed description of the bile duct drainage catheter and the bile duct negative pressure drainage system provided by the present invention. For those skilled in the art, any obvious changes made to it without departing from the essence of the present invention will constitute an infringement of the patent right of the present invention and will bear the corresponding legal liability.

Claims

1. A drainage catheter for the bile duct, characterized in that include: A connector, used for connecting with a liquid storage device; A tube body, the proximal end of which is connected to the joint, and the distal end of which has a drainage section; wherein a plurality of drainage holes are provided on the outer wall of the drainage section, and the end of the drainage section has a drainage tip for inserting into the bile duct; A pull wire is inserted into the tube body, a pull wire hole is opened on the outer wall of the tube body, one end of the pull wire is buried in the drainage tip, and the other end is inserted into the tube body and led out from the joint; Among them, pulling the pull wire can make the drainage tip drive the drainage section to bend from a horizontal state into a pigtail-shaped circle; and the center line of the drainage tip and the center line of the drainage section are located in the same plane, and the multiple drainage holes and the drainage tip are all located on the inner side of the pigtail-shaped circle.

2. The drainage catheter according to claim 1, characterized in that: The length of the drainage tip is L1, the outer diameter of the drainage tip is d2, the outer diameter of the tube body is d1, the diameter of the pigtail circle is D1, and the gap between the outer wall of the drainage tip and the inner wall of the pigtail circle is g, then: Among them, the value of d1 is determined according to the specifications of the drainage catheter; the value of d2 is determined according to the specifications of the guide wire; L1 and D1 are both unknown quantities and are positively correlated.

3. The drainage catheter according to claim 1, characterized in that: The outer side of the tube is coated with a hydrophilic coating to reduce friction with human tissue; The inner side of the tube is coated with a hydrophobic coating to prevent liquid from adhering to the inner wall of the tube.

4. The drainage catheter according to claim 1, characterized in that: A fixing sheet is also provided on the outer wall of the tube body, and the fixing sheet is used to be connected with a catheter holder to limit the axial movement of the tube body.

5. A bile duct negative pressure drainage system, characterized in that include: Negative pressure instrument, used to provide negative pressure and perform pressure detection; A liquid storage device connected to the negative pressure meter so as to form a negative pressure inside the liquid storage device through the negative pressure meter; The drainage catheter according to any one of claims 1 to 4, wherein the connector is connected to the liquid storage device, and the drainage tip is used for insertion into the bile duct during percutaneous transhepatic biliary drainage; A catheter fixer is connected to the tube body and is used to fix the tube body to the skin surface near the bile duct.

6. The biliary negative pressure drainage system according to claim 5, characterized in that The catheter holder comprises: Dressings, which are applied to the skin near the bile duct; The catheter fixing seat comprises a base and an upper cover, wherein the base is fixed to the surface of the dressing and a limiting hole is provided on the base; the upper cover is reversibly connected to the top of the base, and a limiting column is extended toward the base from a side of the upper cover facing the base; Among them, a fixing plate is also provided on the outer wall of the tube body, and a fixing hole is opened on the fixing plate; the fixing plate is used to be placed on the base, and the fixing hole is aligned with the limiting hole so that the limiting column can pass through the fixing hole and be inserted into the limiting hole.

7. The biliary negative pressure drainage system according to claim 6, characterized in that The catheter holder also includes: A connecting tube, wherein the first end of the connecting tube is connected to the dressing, and the dressing is provided with an opening portion connected to the connecting tube; the second end of the connecting tube is connected to the negative pressure meter so that a negative pressure area is formed between the dressing and the skin surface through the negative pressure meter.

8. The biliary negative pressure drainage system according to claim 5, characterized in that The liquid storage device comprises: A housing having a closed hollow inner cavity; An air outlet pipe, a first end of which is communicated with the housing, and a second end of which is connected with the negative pressure instrument; A liquid inlet pipe, a first end of which is communicated with the housing, and a second end of which is connected with the joint; a water blocking filter, disposed in the hollow inner cavity and connected to the first end of the gas outlet pipe, for passing gas and blocking liquid; A backflow prevention member, disposed in the hollow inner cavity and connected to the first end of the liquid inlet pipe, for preventing the liquid from backflowing back into the liquid inlet pipe; The liquid absorption part is arranged in the hollow inner cavity and is used for absorbing liquid.

9. The biliary negative pressure drainage system according to claim 8, characterized in that: The backflow prevention member comprises an inner film layer and an outer film layer, wherein the inner film layer is located inside the outer film layer, and the inner film layer and the outer film layer are simultaneously sealed on the top by a hot pressing process, and the side edges are sealed separately, and the bottom is open to form a liquid inlet channel in the inner film layer; the first end of the liquid inlet pipe is connected to the liquid inlet channel; Wherein, under negative pressure, liquid flows from the liquid inlet pipe into the liquid inlet channel and flows toward the liquid suction part; under normal pressure, the inner film layer and the outer film layer are automatically closed to block the liquid inlet channel.

10. The biliary negative pressure drainage system according to claim 9, characterized in that: The liquid inlet channel is a wide-mouth single channel or a narrow-mouth multi-channel.

Images