A post-bile external drainage and reinfusion filtering device for hepatobiliary surgery

Abstract

The present application relates to the technical field of medical auxiliary apparatus, in particular to a kind of hepatobiliary surgery bile external drainage post-filtering device for back feeding, including first drainage tube and drainage bag, drainage bag bottom is equipped with second drainage tube, second drainage tube is equipped with filter away from drainage bag one end, filter includes equipment shell, viscosity detection module, viscosity adjusting module and filtering and collection module are sequentially equipped in equipment shell along the direction of away from drainage bag;Viscosity detection module is used to transport and real-time acquisition bile fluid's viscosity parameter;Viscosity adjusting module includes helical structure's mixing pipe, and dilution component and temperature control component are equipped on mixing pipe;Filtering and collection module includes filter component and collection component;The present application adds the viscosity detection before bile filtration and corresponding viscosity adjustment, adapts the bile viscosity characteristics of different patients with different conditions, reduces the risk of filter blockage or incomplete filtration caused by viscosity fluctuation, improves the stability of filtering efficiency.

Description

Technical Field

[0001] This invention relates to the field of medical auxiliary device technology, specifically to a bile external drainage and reinfusion filtration device for hepatobiliary surgery. Background Technology

[0002] After receiving external bile drainage, patients with biliary obstruction require strict filtration procedures before bile reinfusion to reduce digestive fluid loss, promote enterohepatic circulation, and improve liver function. Afterward, bile can be reinfused via oral feeding or nasoenteric feeding tube, depending on the patient's specific condition.

[0003] In clinical applications of bile reinfusion, various specialized devices have emerged to address the filtration needs of bile after drainage. For example, Chinese Patent Publication No. CN216125284U discloses a bile drainage and filtration device. This device uses a multi-stage interconnected drainage pipeline as its core carrier, integrating a drainage pipeline with universal and spiral connectors, a filter bag assembly with a built-in precision filter screen, and a sealed storage bag equipped with graduation markings, a suspension structure, and a puncture-type rubber stopper. During clinical operation, bile is introduced into the first drainage tube, and after impurities are efficiently intercepted by the filter screen inside the filter bag, it flows into the storage bag through the second and third drainage tubes to complete collection. Compared with the traditional bile transfer filtration mode, this device achieves integrated drainage, filtration, and storage functions, which reduces the workload of medical staff and shortens the contact time between bile and the external environment, thereby improving the cleanliness of the reinfused bile.

[0004] However, the aforementioned bile drainage and filtration devices do not fully consider the key variable of individual differences in bile viscosity caused by the heterogeneity of different patients' conditions. Fluctuations in bile viscosity directly change the flow characteristics of the fluid and the sedimentation behavior of impurities, which in turn significantly affects the retention accuracy, flow resistance, and processing throughput of the filtration components, ultimately limiting the stability of the device's filtration efficiency. Therefore, it is necessary to propose a bile external drainage and recirculation filtration device that can dynamically adapt the filtration parameters according to the bile viscosity to achieve efficient and stable filtration of bile of different viscosities. Summary of the Invention

[0005] To address the aforementioned issues, this invention provides a bile external drainage and reinfusion filtration device for hepatobiliary surgery. It incorporates viscosity detection and corresponding viscosity adjustment before bile filtration, adapting to the different bile viscosity characteristics of various patients and their conditions. This reduces the risk of filtration blockage or incomplete filtration caused by viscosity fluctuations and improves the stability of filtration efficiency.

[0006] To achieve the above objectives, the technical solution of the present invention is as follows: a hepatobiliary surgical bile external drainage and reinfusion filtration device, comprising a first drainage tube and a drainage bag, a second drainage tube connected to the bottom of the drainage bag, a filter provided at the end of the second drainage tube away from the drainage bag, the filter comprising a device housing, and a clamping seat provided on the device housing for clamping and installing the device housing on the edge of the bed frame;

[0007] Inside the equipment casing, along the direction away from the drainage bag, are sequentially arranged a viscosity detection module, a viscosity adjustment module, and a filtration and collection module;

[0008] The viscosity detection module is used to transmit and collect the viscosity parameters of bile fluid in real time. The viscosity detection module is connected to a controller for evaluating whether the current bile fluid needs to be diluted and regulated based on the viscosity parameters.

[0009] The viscosity adjustment module includes a spiral-shaped mixing tube, one end of which is connected to the viscosity detection module. The mixing tube is detachably embedded in the device housing. The mixing tube is equipped with a dilution component for supplying physiological saline and for regulating the amount of physiological saline injected. The inner wall of the device housing is also equipped with a temperature control component corresponding to the position of the mixing tube. The temperature control component is used to heat the bile fluid to 35~40℃. Both the temperature control component and the dilution component are connected to the controller signal.

[0010] The filtration and collection module includes a filtration assembly for filtering bile fluid and a collection assembly for temporarily storing the filtered bile fluid.

[0011] The technical principle of the above scheme is as follows: This scheme introduces the patient's bile into a drainage bag through a first drainage tube for temporary storage, and then delivers it to a filter through a second drainage tube. The filter is fixed to the edge of the bed with the help of a clamp, so that the bile input by the second drainage tube in the outer shell of the device can flow sequentially through the viscosity detection module, the viscosity adjustment module, and the filtration and collection module. The viscosity detection module collects the bile viscosity parameters in real time and transmits them to the controller. The controller evaluates the viscosity of the bile fluid and sends a control signal to determine whether the viscosity adjustment module needs to be adjusted. When viscosity dilution adjustment is required, the dilution component in the viscosity adjustment module accurately injects physiological saline and, together with the temperature control component, heats the bile and physiological saline mixture to 35~40℃. The bile and diluent are fully mixed through a spiral mixing tube to adjust the viscosity. Finally, after impurities are filtered by the filtration component, the filtered bile is temporarily stored by the collection component.

[0012] The above approach has the following beneficial effects:

[0013] 1. This solution adds a front-end viscosity detection module and a corresponding viscosity adjustment module to adapt to the bile viscosity characteristics of different patients with different conditions, reduce the risk of filter blockage or incomplete filtration caused by viscosity fluctuations, and improve the stability of filtration efficiency.

[0014] 2. This solution uses a dilution component mixed with physiological saline to dilute the bile and control its viscosity. Physiological saline is used as the dilution medium to disperse colloidal particles and crystalline precipitates in the bile. At the same time, the turbulence enhancement effect of the spiral mixing tube is used to achieve uniform mixing of bile and physiological saline, reducing the apparent viscosity of bile while maintaining the electrolyte balance of bile. This not only provides a low-resistance fluid medium for subsequent filtration, but also eliminates the need for pre-flushing or additional dilution before oral administration through pre-viscosity adaptation treatment, reducing the risk of gastrointestinal irritation caused by direct oral administration of high-viscosity bile.

[0015] 3. This solution combines temperature-controlled heating with a temperature control component to regulate bile viscosity, heating the bile fluid to a physiologically suitable temperature range of 35~40℃. By utilizing the regulatory effect of temperature on the thermal motion of lipid and protein molecules in bile, it reduces intermolecular aggregation forces and internal flow resistance. This avoids the risk of biliary spasm caused by low-temperature bile reinfusion and provides a stable auxiliary pathway for viscosity regulation. It works in conjunction with the physiological saline dilution strategy to regulate bile viscosity.

[0016] Furthermore, the viscosity detection module includes a first flow rate sensor, a venturi tube, and a second flow rate sensor connected sequentially along the direction away from the second flow tube. The first flow rate sensor is connected to the end of the second flow tube near the device housing. The inner diameter of the venturi tube decreases gradually along the direction away from the second flow tube. One end of the second flow rate sensor is connected to the mixing tube.

[0017] The controller receives real-time flow velocity data from the first and second flow velocity sensors as flow velocity data for bile fluid in pipelines of different diameters. It then analyzes and calculates the apparent viscosity parameter of the generated bile and compares this apparent viscosity parameter with the bile reinfusion adaptive viscosity threshold. When the apparent viscosity parameter is greater than or equal to the bile reinfusion adaptive viscosity threshold, the controller sends a control drive signal to the dilution component and the temperature control component. When the apparent viscosity parameter is less than the bile reinfusion adaptive viscosity threshold, the controller determines that the current bile fluid viscosity is normal.

[0018] Beneficial effects: The gradient structure of the venturi tube inner diameter accelerates bile flow, creating a flow velocity difference in bile fluid to facilitate viscosity detection. Through the coordinated monitoring of the first and second flow velocity sensors, real-time dynamic assessment of bile viscosity can be achieved.

[0019] Furthermore, the dilution assembly includes a diluent storage tank and a signal dispenser. The diluent storage tank is detachably installed on the outer wall of the equipment housing and is filled with physiological saline.

[0020] The second flow rate sensor, mixing tube, and diluent storage tank are all connected to the signal dispenser;

[0021] The passage between the signal dispenser and the diluent storage tank is normally closed. When the signal dispenser receives a control drive signal from the controller, it adjusts the conduction time of the passage between itself and the diluent storage tank to control the amount of physiological saline injected.

[0022] Beneficial effects: The signal dispenser receives the control signal from the controller and adjusts the conduction time of the passage between it and the diluent storage tank to control the amount of saline injected. Under normal circumstances, the passage is kept closed to avoid waste of saline. When dilution is required, the corresponding dose of saline is injected precisely. The saline reduces the viscosity of bile and reduces the risk of clogging of the filter components. At the same time, the detachable diluent storage tank facilitates replenishment and replacement, improving the practicality of the device.

[0023] Furthermore, the temperature control component includes a heat-conducting plate and a temperature control plate. The heat-conducting plate is embedded in the inner wall of the equipment shell. Several corresponding spiral mixing tubes are provided on the heat-conducting plate. The tube body of the mixing tube is correspondingly fixed in several fixing grooves. The temperature control plate is attached and fixed to the side of the heat-conducting plate away from the mixing tube.

[0024] Beneficial effects: The heat from the temperature control plate is evenly transferred to the mixing tube in the embedded groove through the heat conduction plate. The embedded groove design not only fixes the position of the mixing tube, but also increases the heat contact area and improves the heating efficiency.

[0025] Furthermore, a cover corresponding to the position of the mixing tube is detachably installed on one side of the equipment casing.

[0026] Beneficial effects: The opening of the cover corresponds to the position of the mixing tube, which makes it easy for medical staff to install, disassemble or replace the mixing tube after opening it, without having to disassemble the entire equipment shell, thus simplifying the maintenance operation process.

[0027] Furthermore, the filter assembly includes a filter head, with a filter chamber at the bottom of the filter head, and the filter chamber is connected to the mixing tube;

[0028] The collection component includes a collection box, a slot is provided on the side wall of the filter head, and a retaining ring corresponding to the slot is fixedly connected to the top of the inner side wall of the collection box;

[0029] The bottom of the filter chamber is equipped with filter cloth, which is pressed and laid at the bottom of the filter chamber by a snap-fit ​​operation between the collection box and the filter head.

[0030] Beneficial effects: By engaging the snap ring on the top of the collection box with the snap groove on the side wall of the filter head, the filter cloth is pressed and secured to the bottom of the filter chamber, enabling quick assembly and disassembly of the filter assembly and collection assembly. The filter cloth can be replaced without the need for tools, improving the convenience of clinical operation.

[0031] Furthermore, the inner diameter of the filter chamber decreases gradually in the direction away from the mixing tube.

[0032] Beneficial effects: This shape design guides bile to gather in the central area of ​​the filter cloth, reducing the accumulation and clogging of impurities at the edges of the filter cloth and expanding the effective filtration area of ​​the filter cloth.

[0033] Furthermore, a return assembly is provided at the bottom of the collection box. The return assembly includes a negative pressure drive and a collection tube. The collection tube is embedded in the bottom wall of the collection box and communicates with the collection box. The negative pressure output end of the negative pressure drive is connected to the collection tube, and the positive pressure output end of the negative pressure drive is connected to the return tube.

[0034] Beneficial effects: The negative pressure drive generates negative pressure suction, which draws the filtered bile from the collection box through the collection tube, and then delivers it to the patient's nutrition input tube through the positive pressure output end and the return tube, realizing the direct return of filtered bile without the need for manual transfer of bile, reducing operation steps and the risk of contamination.

[0035] Furthermore, the negative pressure drive includes a peristaltic pump, which is signal-connected to the controller.

[0036] Beneficial effects: Peristaltic pumps can generate negative pressure suction and positive pressure thrust by periodically squeezing the collection tube with rollers, realizing contactless transfer of bile between the pump body and the pump body components. Compared with the interventional pumping of traditional pump bodies, this can reduce the risk of bile contamination.

[0037] Furthermore, a pressure relief distributor is also provided near the second drainage tube on the outer casing of the device. The pressure relief distributor is connected to the pipeline of the second drainage tube and has an atmospheric connection port. An air filter is installed on the atmospheric connection port. The pressure relief distributor is connected to the controller signal. When the peristaltic pump starts, the pressure relief distributor triggers the electromagnetic on / off switching mechanism, which connects the second drainage tube to the atmospheric connection port. The negative pressure driving force used to drive the bile fluid return is released through the atmospheric connection port.

[0038] Beneficial effects: When the peristaltic pump is started, the pressure relief dispenser triggers an electromagnetic on / off switch, connecting the second drainage tube to the atmospheric port. This releases the negative pressure driving force through the atmospheric port, reducing the risk of negative pressure being transmitted back to the patient's drainage end and minimizing the risk of mechanical damage to the bile duct mucosa and adjacent tissues caused by continuous negative pressure.

[0039] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0040] Figure 1 This is a schematic diagram of the overall structure of an embodiment of the hepatobiliary surgery bile external drainage and reinfusion filtration device of the present invention;

[0041] Figure 2 This is an isometric sectional view of the filter in an embodiment of the hepatobiliary surgery bile external drainage and reinfusion filtration device of the present invention;

[0042] Figure 3 This is a schematic front cross-sectional view of the viscosity detection module in an embodiment of the hepatobiliary surgical bile external drainage and reinfusion filtration device of the present invention;

[0043] Figure 4 This is a partial exploded view of the viscosity adjustment module in an embodiment of the hepatobiliary surgical bile external drainage and reinfusion filtration device of the present invention;

[0044] Figure 5 This is a partial exploded view of the filtration and collection module in an embodiment of the hepatobiliary surgical bile external drainage and reinfusion filtration device of the present invention;

[0045] Figure 6 This is an isometric view of the arrangement of the diluent storage tank in an embodiment of the hepatobiliary surgical bile external drainage and reinfusion filtration device of the present invention;

[0046] Figure 7 This is an isometric view of the filter assembly after installation of the reinfusion component in an embodiment of the bile external drainage and reinfusion filtration device for hepatobiliary surgery of the present invention.

[0047] The reference numerals in the accompanying drawings include: 1. First drainage tube; 2. Drainage bag; 3. Second drainage tube; 4. Equipment housing; 5. First flow rate sensor; 6. Venturi tube; 7. Second flow rate sensor; 8. Mixing tube; 9. Diluent storage tank; 10. Signal distributor; 11. Heat-conducting plate; 1101. Embedding groove; 12. Temperature control plate; 13. Filter head; 1301. Filter chamber; 1302. Slot; 14. Collection box; 1401. Snap ring; 15. Filter cloth; 16. Opening; 17. Negative pressure drive; 18. Collection tube; 19. Pressure relief distributor; 1901. Atmospheric connection port; 20. Return pipe. Detailed Implementation

[0048] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0049] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0050] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0051] The following detailed description illustrates the specific implementation method:

[0052] Example 1:

[0053] This embodiment provides a bile external drainage and reinfusion filtration device for hepatobiliary surgery, specifically as follows: Figure 1 As shown, it includes a first drainage tube 1 and a drainage bag 2. The bottom of the drainage bag 2 is connected to a second drainage tube 3, and a filter is provided at the end of the second drainage tube 3 away from the drainage bag 2.

[0054] The filter includes a housing 4, which has a clamping seat (not shown in the figure, preferably a MED-CL-03 type quick-release U-shaped clamping seat) for clamping and installing the housing 4 on the edge of the bed. Medical staff can use the clamping seat to firmly clamp the housing 4 to the side of the patient's bed, which can not only ensure the long-term connection stability between the drainage tube and the drainage bag 2 during clinical drainage, but also constrain the spatial posture of the housing 4, ensuring that the inside of the housing 4 is always in a suitable environment for bile fluid drainage and filtration.

[0055] The special feature of this embodiment is that, unlike the prior art where the device casing 4 is sequentially equipped with a viscosity detection module, a viscosity adjustment module, and a filtration and collection module along the direction away from the drainage bag 2, this embodiment adds viscosity detection of bile fluid and viscosity adjustment based on bile viscosity before conventional bile fluid filtration, specifically combined with... Figure 1 and Figure 2 As shown:

[0056] First, the viscosity detection module includes a first velocity sensor 5, a venturi tube 6, and a second velocity sensor 7 (e.g., connected sequentially along a direction away from the second drainage tube 3). Figure 3 As shown in the arrangement, the first flow rate sensor 5 is connected to the end of the second drainage tube 3 near the device housing 4. The inner diameter of the venturi tube 6 decreases gradually in the direction away from the second drainage tube 3. One end of the second flow rate sensor 7 is connected to the mixing tube 8 (both the first flow rate sensor 5 and the second flow rate sensor 7 are preferably FS-100 type in-line flow rate sensors). After the bile fluid flows through the drainage bag 2, it flows in the direction of second drainage tube 3 - first flow rate sensor 5 - venturi tube 6 - second flow rate sensor 7. Both the first flow rate sensor 5 and the second flow rate sensor 7 monitor the flow rate of the bile fluid in real time.

[0057] The viscosity detection module also includes a controller. The controller receives real-time flow velocity data collected by the first flow velocity sensor 5 and the second flow velocity sensor 7 as flow velocity data of bile fluid in pipelines of different diameters. The controller analyzes and converts the apparent viscosity parameter of the generated bile (referencing the differential pressure correction viscosity calculation model in the prior art, such as the derivative fluid analysis module of the hemodynamic monitoring system in the existing medical field). The apparent viscosity parameter is compared with the bile reinfusion adaptive viscosity threshold. When the apparent viscosity parameter is greater than or equal to the bile reinfusion adaptive viscosity threshold (the establishment of the reinfusion adaptive viscosity threshold is based on the reference range of adult bile physiological viscosity, combined with physiological indicators such as patient age, biliary tract disease type, and serum bilirubin level for stratified statistical analysis, and matched with the fluid resistance characteristics of the mixing tube 8 and the flow-pressure response curve of the Venturi tube 6, and the critical threshold range is determined after orthogonal experiment and machine learning algorithm optimization), the controller sends a control drive signal to the viscosity adjustment module. When the apparent viscosity parameter is less than the bile reinfusion adaptive viscosity threshold, the controller determines that the current bile fluid viscosity is normal.

[0058] Secondly, this embodiment uses bile dilution (i.e., mixing physiological saline into bile to adjust bile viscosity) and temperature control to adjust bile viscosity, specifically in combination with... Figure 2 and Figure 4 As shown: The viscosity adjustment module includes a spiral-shaped mixing tube 8, one end of which is connected to the second flow rate sensor 7. The mixing tube 8 is detachably embedded in the device housing 4.

[0059] The spiral-shaped mixing tube 8 extends the contact distance between bile and saline within the device, improving the uniformity and fluidity of the diluted bile, reducing the risk of clogging in subsequent bile filtration, and providing a stable fluid basis for precise flow rate control in the reinfusion process.

[0060] Regarding the viscosity coefficient of the saline solution, this embodiment includes a dilution assembly on the mixing tube 8 for supplying saline solution and regulating the saline solution injection volume. The dilution assembly includes a diluent storage tank 9 and a signal dispenser 10 (e.g., Figure 6 As shown, the diluent storage tank 9 is detachably installed on the outer wall of the equipment housing 4, and is filled with physiological saline. The second flow rate sensor 7, the mixing tube 8, and the diluent storage tank 9 are all connected to the signal distributor 10. The passage between the signal distributor 10 and the diluent storage tank 9 is normally closed. When the signal distributor 10 receives the control drive signal sent by the controller (the control drive signal contains the control information of the physiological saline injection time), the signal distributor 10 adjusts the conduction time of the passage between itself and the diluent storage tank 9 to control the amount of physiological saline injected.

[0061] Using physiological saline as a bile diluent to regulate bile viscosity can reduce the chemical irritation of bile duct mucosa by adjusting bile osmotic pressure, thus avoiding discomfort such as abdominal pain and nausea in patients (facilitating subsequent bile filtration and reinfusion). Furthermore, the low viscosity of physiological saline can create a fluid shearing effect in the 8-channel mixing tubing, effectively dispersing bile salt crystals and flocculent precipitates in the bile (reducing the risk of clogging of subsequent precision filtration components).

[0062] Regarding heating and dilution, this embodiment also includes a temperature control component on the inner wall of the equipment housing 4 corresponding to the position of the mixing tube 8, specifically combined with... Figure 2 and Figure 4 The temperature control component includes a heat-conducting plate 11 and a temperature control element 12 (preferably a thermoelectric cooling element capable of signal-controlled temperature regulation). The temperature control element 12 is connected to the controller via a signal. The heat-conducting plate 11 is embedded in the inner wall of the equipment housing 4. The heat-conducting plate 11 has several corresponding mounting grooves 1101 for the spiral mixing tubes 8. The tube body of the mixing tubes 8 is correspondingly fixed in the mounting grooves 1101. The temperature control element 12 is attached and fixed to the side of the heat-conducting plate 11 away from the mixing tubes 8. When the temperature control element 12 receives the control drive signal sent by the controller, the temperature control element 12 starts to heat and dilute the mixed liquid in the mixing tubes 8. The heating temperature control range of the temperature control element 12 is 35~40℃.

[0063] Heating dilutes bile viscosity, which not only maintains the bile temperature in the optimal range of 37-38℃, close to the core body temperature, in bile reinfusion technology, avoiding adverse reactions such as biliary spasm and heart rate fluctuations caused by low-temperature bile reinfusion, thus improving patient reinfusion comfort and oral acceptance; but also utilizes the linear regulation of bile viscosity by temperature, reducing the apparent viscosity of bile by increasing the temperature within the physiologically safe temperature range, reducing bile salt polymerization and cholesterol crystal precipitation, and optimizing fluid flow.

[0064] The filtration and collection module includes a filtration assembly for filtering bile fluid and a collection assembly for temporarily storing the filtered bile fluid, specifically combined... Figure 2 and Figure 5 As shown:

[0065] The filtration assembly includes a filter head 13, with a filter chamber 1301 at the bottom. The inner diameter of the filter chamber 1301 decreases gradually away from the mixing tube 8 (guiding bile fluid downwards). The filter chamber 1301 is connected to the mixing tube 8. The collection assembly includes a collection box 14, with a slot 1302 on the side wall of the filter head 13. A retaining ring 1401 corresponding to the slot 1302 is fixedly connected to the top of the inner side wall of the collection box 14. A filter cloth 15 is provided at the bottom of the filter chamber 1301. The filter cloth 15 is pressed and laid at the bottom of the filter chamber 1301 through a snap-fit ​​disassembly and assembly operation between the collection box 14 and the filter head 13. This snap-fit ​​disassembly and assembly design of the filter cloth 15 can improve the convenience of clinical operation, without the need for any tools, and is suitable for the rapid response needs of emergency bile duct reinfusion treatment in the operating room. It also facilitates the replacement of the collection box 14 and the filter cloth 15 after surgery, as well as the disassembly, cleaning and disinfection of the components, effectively reducing the difficulty of hospital infection control.

[0066] After viscosity adjustment, the bile fluid flows from the mixing tube 8 into the filtration chamber 1301. In the filtration chamber 1301, it flows downwards, and impurities such as bile salt crystals and flocculent precipitates are trapped as it passes through the filter cloth 15. The clarified bile then flows through the filter cloth 15 and falls into the collection box 14 below, completing the filtration and collection process. When the collection box 14 contains a sufficient amount of filtered bile, the locking ring 1401 and the locking groove 1302 can be released to disassemble the collection box 14. Sugar or honey can be added to the collection box 14 to adjust the taste, and the patient can then take it orally. The bile, after being diluted with physiological saline and temperature-controlled, has a viscosity close to physiological levels and a suitable temperature, requiring no additional heating or dilution. This results in a milder and smoother taste for the patient, avoiding gastrointestinal irritation caused by low-temperature bile and reducing swallowing discomfort caused by high-viscosity bile. This significantly improves the convenience and patient acceptance of oral bile reinfusion.

[0067] In addition, a cover 16 corresponding to the position of the mixing pipe 8 is detachably installed on one side of the equipment housing 4 (e.g., Figure 4As shown in the figure), the installation process of the entire bile drainage and reinfusion device is as follows: Medical staff first detachably install the diluent storage tank 9 filled with physiological saline on the designated position on the outer wall of the device shell 4. Then, they open the detachable cover 16 corresponding to the position of the mixing tube 8, and fix the spiral mixing tube 8 into the mounting groove 1101 of the heat-conducting plate 11, and complete the sealed connection with the signal distributor 10 and the filter chamber 1301. Then, they lay the filter cloth 15 at the bottom of the filter chamber 1301. The collection box 14 is assembled and fixed by the snap-fit ​​of the retaining ring 1401 on the top of the collection box 14 and the retaining groove 1302 on the side wall of the filter head 13. Then, they connect the second flow rate sensor 7, the temperature control plate 12, and the signal distributor 10 to the controller to complete the signal line connection. Finally, they close the detachable cover 16 to complete the mechanical assembly and circuit debugging of the entire bile drainage and reinfusion device.

[0068] Example 2:

[0069] The difference between this embodiment and Embodiment 1 is that, specifically as follows: Figure 7 As shown, the bottom of the collection box 14 is equipped with a return assembly, which includes a negative pressure drive 17 and a collection tube 18. The collection tube 18 is embedded in the bottom wall of the collection box 14 and communicates with the collection box 14. The negative pressure drive 17 includes a peristaltic pump, which is signal-connected to the controller. The negative pressure output end of the peristaltic pump is connected to the collection tube 18, and the positive pressure output end of the peristaltic pump is connected to the return tube 20. The other end of the return tube 20 can be connected to the patient's nasoenteric tube, jejunal tube, or other nutritional input auxiliary tubes. The peristaltic pump is selected to utilize the negative pressure suction generated by the periodic squeezing of the tubing by its rollers to draw the filtered clear bile in the collection box 14 through the collection tube 18, and then push the bile at a constant speed to the return tube 20 through positive pressure. Compared with other types of pumps, the peristaltic pump realizes non-contact transmission of bile fluid to the pump body components, reducing the risk of fluid contamination.

[0070] Specifically, the device housing 4 is equipped with a pressure relief distributor 19 near the second drainage tube 3. The pressure relief distributor 19 is connected to the pipeline of the second drainage tube 3. The pressure relief distributor 19 is provided with an atmospheric connection port 1901, which is equipped with an air filter. The pressure relief distributor 19 is connected to the controller signal. When the peristaltic pump is started, the pressure relief distributor 19 triggers the electromagnetic on / off switching mechanism, connecting the second drainage tube 3 to the atmospheric connection port 1901. The negative pressure driving force used to drive bile fluid reinfusion is released through the atmospheric connection port 1901, thereby reducing the probability of the negative pressure force being transmitted back to the drainage end in the patient's body. This reduces the risk of mechanical damage to the patient's bile duct mucosa and adjacent tissues caused by continuous negative pressure stimulation, ensuring the safety and comfort of clinical drainage and reinfusion operations.

[0071] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A hepatobiliary surgical bile external drainage and reinfusion filtration device, comprising a first drainage tube (1) and a drainage bag (2), wherein a second drainage tube (3) is connected to the bottom of the drainage bag (2), characterized in that, The second drainage tube (3) has a filter at the end away from the drainage bag (2). The filter includes a device housing (4). The device housing (4) is provided with a clamping seat for clamping and installing the device housing (4) on the edge of the bed. The device housing (4) is provided with a viscosity detection module, a viscosity adjustment module and a filtration and collection module in sequence along the direction away from the drainage bag (2); The viscosity detection module is used to transmit and collect the viscosity parameters of bile fluid in real time. The viscosity detection module is connected to a controller for evaluating whether the current bile fluid needs to be diluted and regulated based on the viscosity parameters. The viscosity adjustment module includes a spiral-shaped mixing tube (8), one end of which is connected to the viscosity detection module. The mixing tube (8) is detachably embedded in the equipment housing (4). The mixing tube (8) is equipped with a dilution component for supplying physiological saline and having the function of adjusting the amount of physiological saline injected. The inner wall of the equipment housing (4) is also equipped with a temperature control component corresponding to the position of the mixing tube (8). The temperature control component is used to heat the bile fluid to 35~40℃. Both the temperature control component and the dilution component are connected to the controller signal. The filtration and collection module includes a filtration assembly for filtering bile fluid and a collection assembly for temporarily storing the filtered bile fluid.

2. The hepatobiliary surgical bile external drainage and reinfusion filtration device according to claim 1, characterized in that, The viscosity detection module includes a first flow rate sensor (5), a venturi tube (6), and a second flow rate sensor (7) connected sequentially along the direction away from the second flow tube (3). The first flow rate sensor (5) is connected to the end of the second flow tube (3) near the equipment housing (4). The inner diameter of the venturi tube (6) decreases gradually along the direction away from the second flow tube (3). One end of the second flow rate sensor (7) is connected to the mixing tube (8). The controller receives real-time flow velocity data collected by the first flow velocity sensor (5) and the second flow velocity sensor (7) as flow velocity data of bile fluid in pipelines of different diameters, analyzes and calculates the apparent viscosity parameter of the generated bile, and compares the apparent viscosity parameter with the bile reinfusion adaptation viscosity threshold. When the apparent viscosity parameter is greater than or equal to the bile reinfusion adaptation viscosity threshold, the controller sends a control drive signal to the dilution component and the temperature control component. When the apparent viscosity parameter is less than the bile reinfusion adaptation viscosity threshold, the controller determines that the current bile fluid viscosity is normal.

3. The hepatobiliary surgical bile external drainage and reinfusion filtration device according to claim 2, characterized in that, The dilution assembly includes a diluent storage tank (9) and a signal dispenser (10). The diluent storage tank (9) is detachably installed on the outer wall of the equipment housing (4). The diluent storage tank (9) is filled with physiological saline. The second flow rate sensor (7), the mixing tube (8), and the diluent storage tank (9) are all connected to the signal dispenser (10); The passage between the signal dispenser (10) and the diluent storage tank (9) is normally closed. When the signal dispenser (10) receives the control drive signal sent by the controller, the signal dispenser (10) adjusts the conduction time of the passage between itself and the diluent storage tank (9) to control the amount of physiological saline injected.

4. The hepatobiliary surgical bile external drainage and reinfusion filtration device according to claim 3, characterized in that, The temperature control component includes a heat-conducting plate (11) and a temperature control plate (12). The heat-conducting plate (11) is embedded in the inner wall of the equipment housing (4). The heat-conducting plate (11) has several corresponding mounting grooves (1101) for the spiral mixing tube (8). The tube body of the mixing tube (8) is correspondingly fixed in the mounting grooves (1101). The temperature control plate (12) is attached and fixed to the side of the heat-conducting plate (11) away from the mixing tube (8).

5. The hepatobiliary surgical bile external drainage and reinfusion filtration device according to claim 4, characterized in that, The equipment housing (4) has a detachable cover (16) on one side corresponding to the position of the mixing pipe (8).

6. The hepatobiliary surgical bile external drainage and reinfusion filtration device according to claim 5, characterized in that, The filter assembly includes a filter head (13), and a filter chamber (1301) is provided at the bottom of the filter head (13), which is connected to the mixing tube (8); The collection assembly includes a collection box (14), a slot (1302) is provided on the side wall of the filter head (13), and a retaining ring (1401) corresponding to the slot (1302) is fixedly connected to the top of the inner side wall of the collection box (14). The bottom of the filter chamber (1301) is provided with filter cloth (15). The filter cloth (15) is pressed and laid at the bottom of the filter chamber (1301) by the snap-on disassembly and assembly operation between the collection box (14) and the filter head (13).

7. The hepatobiliary surgical bile external drainage and reinfusion filtration device according to claim 6, characterized in that, The inner diameter of the filter chamber (1301) decreases gradually in the direction away from the mixing tube (8).

8. The hepatobiliary surgical bile external drainage and reinfusion filtration device according to claim 7, characterized in that, The bottom of the collection box (14) is provided with a return assembly, which includes a negative pressure drive (17) and a collection tube (18). The collection tube (18) is embedded in the bottom wall of the collection box (14) and communicates with the collection box (14). The negative pressure output end of the negative pressure drive (17) is connected to the collection tube (18), and the positive pressure output end of the negative pressure drive (17) is connected to the return tube (20).

9. The hepatobiliary surgical bile external drainage and reinfusion filtration device according to claim 8, characterized in that, The negative pressure drive (17) includes a peristaltic pump, which is signal-connected to the controller.

10. The hepatobiliary surgical bile external drainage and reinfusion filtration device according to claim 9, characterized in that, The outer casing (4) of the device is also equipped with a pressure relief distributor (19) near the second drainage tube (3). The pressure relief distributor (19) is connected to the pipeline of the second drainage tube (3). The pressure relief distributor (19) is equipped with an atmospheric connection port (1901). An air filter is installed on the atmospheric connection port (1901). The pressure relief distributor (19) is connected to the controller signal. When the peristaltic pump is started, the pressure relief distributor (19) triggers the electromagnetic on / off switching mechanism to connect the second drainage tube (3) and the atmospheric connection port (1901). The negative pressure driving force used to drive the bile fluid return is released through the atmospheric connection port (1901).

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