A gas-liquid separation and drainage module integrating multiple functional interfaces and liquid level sensors

Abstract

The application discloses a gas-liquid separation drainage module integrating multiple function interfaces and liquid level sensors and belongs to the technical field of medical devices. The module comprises a gas-liquid separation container main body made of transparent medical-grade plastic, which is divided into an independent water seal chamber and a liquid collecting cavity by a water seal partition plate; a liquid inlet and a multifunctional interface are integrated on the top of the container, a hydrophobic filter device and an anti-overflow partition plate are arranged on the inner side of the multifunctional interface to form double protection, and an electronic gas circuit valve is arranged downstream and used for switching between normal pressure drainage and negative pressure drainage modes; a liquid discharge pipe and a staged liquid level monitoring electrode are arranged at the bottom of the container. The application can also be optionally provided with a color recognition component, which can dynamically monitor the color change of the drainage liquid in real time and output an early warning signal. The application ensures constant water seal pressure, realizes continuous automatic monitoring of the color of the drainage liquid and liquid level gradient early warning, supports mode switching of negative pressure suction and gas monitoring, and has the advantages of high integration, good safety and strong clinical adaptability.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a gas-liquid separation device for pleural or abdominal drainage, and particularly to a modular gas-liquid separation drainage device that integrates dynamic color recognition of drainage fluid and can be used independently or in conjunction with an external drainage monitoring host. Background Technology

[0002] Closed thoracic and abdominal drainage is a routine surgical procedure used to drain gas, blood, pus, or other fluid from the thoracic and abdominal cavities. During drainage, changes in the color of the drainage fluid are important clinical indicators for assessing the patient's condition. For example, bright red drainage fluid suggests active bleeding, whitish or purulent fluid suggests infection, dark green / brown fluid suggests bile leakage, and milky white fluid suggests a chylous fistula.

[0003] However, the current clinical judgment of drainage fluid color mainly relies on the visual observation of medical staff, which has the following problems: First, it is highly subjective, and different people have different descriptions and judgment standards for the same color; second, continuous monitoring cannot be achieved, especially at night or when there are insufficient nursing staff, it is difficult to detect abnormal changes in drainage fluid color in time; third, there is a lack of quantitative data, which cannot provide an objective basis for clinical decision-making.

[0004] Existing technologies disclose several drainage devices with color recognition functions. For example, Chinese patent CN204563072U proposes setting a color card on the outer surface of the drainage bag for manual comparison; Chinese patent CN222336425U discloses a drainage fluid monitoring device that collects the color and transparency of the drainage fluid through an image acquisition module. However, most existing solutions fix the color sensor to the main drainage bag or a large-capacity drainage bottle (as described in CN222336425U). The sensor collects the static color of a large amount of mixed accumulated fluid, which not only has shortcomings such as monitoring lag and data distortion, but also fails to combine with the dynamic liquid flow in the gas-liquid separation process, resulting in the inability to achieve real-time monitoring.

[0005] In addition, although existing gas-liquid separation devices can achieve gas-liquid separation and water sealing functions, they generally lack the ability to actively monitor the properties of the drainage fluid. The color recognition of the drainage fluid needs to be completed by external independent equipment, resulting in low integration and inconvenience in use. Summary of the Invention

[0006] Purpose of the invention The purpose of this invention is to overcome the shortcomings of the prior art and provide a gas-liquid separation drainage module that integrates multiple functional interfaces and a liquid level sensor to achieve real-time, continuous, and automated dynamic monitoring of the drainage fluid color for warning of complications such as bleeding and infection. At the same time, it adopts a further optimized water seal structure design to maintain a constant maximum water seal liquid level and prevent the water seal pressure from increasing with the amount of accumulated fluid, thus ensuring smooth drainage and safety. It also integrates a negative pressure suction interface, which can switch working modes according to clinical needs, improving drainage efficiency and clinical applicability.

[0007] Technical solution

[0008] To achieve the above objectives, the present invention adopts the following technical solution: A gas-liquid separation and diversion module integrating multiple functional interfaces and a liquid level sensor includes a gas-liquid separation container body, a multi-functional interface disposed thereon, and a liquid level sensor.

[0009] The gas-liquid separation container is made of transparent medical-grade plastic and its interior is divided into multiple chambers by a water-sealed partition, including at least an independently configured water-sealed chamber and a liquid collection chamber. The gas-liquid separation container integrates the following functional structures from top to bottom: (a) Top Function Area Top cover: The top of the container, ensuring the airtightness of the entire gas-liquid separation container body during operation.

[0010] Inlet: Located at the top or upper side of the container, it connects to the upstream drainage line to receive drainage from the patient's pleural or abdominal cavity. After the drainage material enters the container through the inlet from the upstream drainage line, the liquid settles to the bottom of the container under gravity, while the gas rises to the top, achieving gas-liquid separation.

[0011] Multifunctional interface: Located on the top of the container, this interface is used to connect to the gas flow sensor and / or carbon dioxide concentration sensor of an external drainage monitoring host, and can also be switched to connect to a negative pressure source. Preferably, an electronic gas circuit valve is installed downstream of this interface for switching between "gas monitoring" and "negative pressure drainage" operating modes, so that gas can be discharged through this interface for analysis by external sensors, or negative pressure can be applied through this interface in negative pressure mode.

[0012] Hydrophobic filter: Located inside the multi-functional interface, it is used to intercept liquids and aerosols while allowing gas to pass through to protect external sensors or negative pressure sources.

[0013] Overflow baffle: Located at the top of the container, it prevents liquid splashing or foam from entering the gas monitoring pipeline during negative pressure suction. The overflow baffle is situated upstream of the hydrophobic filter device. It blocks large droplets and foam during negative pressure suction or when there is excessive foam in the drainage liquid, reducing the liquid load on the hydrophobic filter device, thereby extending its effective service life and preventing clogging. Preferably, the container has 1-2 overflow baffles, located near the water seal chamber or near the multi-functional interface. The overflow baffles, in conjunction with the hydrophobic filter device, form a dual protection mechanism, effectively preventing liquid and aerosol from entering the external sensor, protecting the precision sensor components, and improving the system's reliability and service life.

[0014] (ii) Central functional chamber Water seal pipe: Connected to the liquid inlet, it extends downwards from the liquid inlet to the bottom of the independent water seal chamber, and is used to guide the drainage material into the water seal chamber and establish a water seal.

[0015] Independent water seal chamber: An independent chamber formed by a water seal baffle and a collection chamber, with the lower end of the water seal pipe extending into the bottom of this chamber. The water seal chamber is designed with a constant maximum water seal level; that is, the overflow port height of the water seal chamber determines the upper limit of the water seal level. For example, the upper limit of the water seal level is set to 3-6 cm. When the water seal fluid exceeds 3-6 cm, it automatically overflows into the collection chamber. This independent chamber structure ensures that the water seal level in the water seal chamber remains constant regardless of changes in the amount of fluid in the collection chamber, thereby maintaining stable water seal pressure and preventing the accumulation of pleural effusion or gas due to excessively high water seal pressure.

[0016] Liquid collection chamber: This is the other chamber formed by the water seal baffle, used to temporarily store the drained liquid. After the drained liquid enters the liquid collection chamber, it can naturally stratify under the action of gravity (gas rises and liquid sinks), achieving gas-liquid separation.

[0017] (III) Bottom drainage and monitoring area Bottom drain pipe: Located at the bottom of the collection chamber, it drains the collected drainage fluid into the downstream drainage fluid collection container. A shut-off valve can be installed on the bottom drain pipe to control the flow of drainage.

[0018] Liquid level indicator monitoring electrode (first electrode group): Located in the emptying liquid level indication area on the inner wall of the liquid collecting chamber. When the liquid level in the collecting chamber reaches this height, the electrode is activated, and an external device sends an emptying signal. Preferably, the liquid level warning monitoring electrode is located at 75%-80% of the liquid level in the collecting chamber.

[0019] Liquid level warning monitoring electrode (second electrode group): Located in the warning liquid level area on the inner wall of the liquid collecting chamber. When the liquid level in the collecting chamber reaches this height, the electrode is activated, and an external device sends a forced alarm signal, warning that the chamber must be emptied immediately. Preferably, the liquid level warning monitoring electrode is located at 85%-90% of the liquid level in the collecting chamber.

[0020] This graded liquid level electrode alarm mechanism enables gradient early warning of liquid level. The first set of conduction indicates "drainage is required", and the second set of conduction indicates "urgent drainage is necessary", providing clear step-by-step operation guidance for clinical nursing and avoiding misjudgment or delay caused by single threshold alarm.

[0021] In addition to the electrode-type liquid level sensor described above, the liquid level sensor of the present invention may also employ any of the following alternatives: 1. Infrared photoelectric liquid level sensor: An infrared light-emitting diode and a photosensitive receiver are installed on the outer wall of the gas-liquid separation container at the warning liquid level. The sensor detects whether the liquid level has reached the warning position by utilizing changes in the liquid's absorption or refraction of infrared light. This solution is a non-contact detection method, the sensor is reusable, and it is suitable for scenarios where changes in the color of the drainage fluid are not critical.

[0022] 2. Capacitive Liquid Level Sensor: A capacitive detection electrode is installed on the outer wall of the gas-liquid separation container at the warning liquid level. The difference in dielectric constant between the liquid and air inside the container is used to detect changes in liquid level. This solution adopts a split design of "disposable electrode sheet + reusable detection circuit," enabling non-contact detection unaffected by the color and transparency of the drainage liquid, and can also calculate the dynamic drainage volume.

[0023] 3. Ultrasonic Liquid Level Sensor: Located directly above the top cover, this sensor measures the liquid level by emitting ultrasonic waves, receiving the echoes, and calculating the time of flight. This non-contact detection method allows for reusable sensors, is unaffected by the color and transparency of the drainage fluid, and can calculate the dynamic drainage volume.

[0024] (iv) Other optional components Optionally, a color recognition component may also be included to further enhance digital functionality.

[0025] The color recognition component is located in the transparent area of ​​the outer wall between the inlet and the water seal chamber. It is used for coupling with the color recognition sensor of the external monitoring host, or it may be integrated with an independent color recognition sensor module. This area uses an optical glass tube or a highly transparent material to ensure that the sensor accurately captures the color of the drainage fluid rather than the background color of the container. Preferably, the color recognition component is fabricated as an optical glass tube or a highly transparent material conduit, located upstream of the inlet or in the water seal section, to minimize color difference or distortion caused by the drainage fluid being diluted and mixed with the existing liquid after entering the gas-liquid separation container.

[0026] The color recognition component is configured to dynamically monitor the color change of the drainage fluid as it flows through the gas-liquid separation container body, and output a recognition signal according to a preset color-condition mapping relationship.

[0027] The color recognition component includes one of the following two implementation schemes: Option 1 (Passive): A light-transmitting window or color recognition area is set on the outer wall of the container body to couple with the color recognition sensor set on the external monitoring host, so that the sensor can collect the color information of the drainage fluid in the container through the light-transmitting window.

[0028] Option 2 (Active): A color recognition sensor module is fixedly installed on the outer wall of the container body. This module includes a color sensor, a signal processing circuit, and an external interface. The color sensor can be a TCS34711FN color recognition sensor, used to collect drainage fluid color data in real time and output it externally through the external interface. This active color recognition module can be connected to a monitoring host or mobile terminal via wired or wireless means (such as Bluetooth) to achieve independent monitoring of drainage fluid color and remote data transmission.

[0029] Preferably, the color recognition component is further configured to assess the patient's condition based on the changing trend of the drainage fluid color. - When the color of the drainage fluid is detected to be reddish (the red component is significantly increased and exceeds the preset threshold), an active bleeding risk is indicated, triggering an advanced alarm; - When the color of the drainage fluid tends to be milky white or yellow and is accompanied by increased turbidity, it indicates a risk of infection and triggers a medium-level alarm; - When the color of the drainage fluid tends to be dark green or brownish, it may indicate bile leakage or intestinal fistula; - When the color of the drainage fluid is within the preset normal range, record the color data and upload it to the hospital information system.

[0030] This dynamic color trend analysis and early warning mechanism upgrades subjective visual judgment to objective, continuous, and quantitative automated monitoring, enabling early warnings to be issued in the early stages of complications such as bleeding and infection, thus gaining valuable time for clinical intervention.

[0031] (v) Modular capacity combination design Depending on the different needs of clinical scenarios, the gas-liquid separation container body is prepared in various specifications, including small capacity (capacity ≤100mL), medium capacity (capacity ≥200mL), or large capacity (capacity ≥400mL).

[0032] The gas-liquid separation container body can be used independently as a diversion device, either in terms of capacity or large capacity, and can be used in conjunction with an external monitoring host.

[0033] The small-capacity gas-liquid separator body is used in combination with a large-capacity drainage bottle downstream via a bottom drain pipe. The large-capacity drainage bottle is connected to the bottom drain pipe of the gas-liquid separator body via a pipeline and is used to collect and store the drainage fluid.

[0034] Preferably, the gas-liquid separation container body and the large-capacity drainage bottle are detachably connected via a quick connector. This modular capacity design ensures both the sensitivity of color and liquid level monitoring (significant changes in liquid level within a small volume) and meets the needs of long-term continuous drainage, reducing the inconvenience of frequent consumable replacements and balancing monitoring sensitivity with clinical convenience.

[0035] (vi) Switching the working mode of the multi-function interface The multi-functional interface is connected to an external monitoring host to switch interface functions between different operating modes. Preferably, the multi-functional interface is connected to a downstream electronic pneumatic valve, which is electrically connected to the central processing unit of the external monitoring host. This allows for automatic or manual switching between the following two operating modes based on clinical needs: (1) Normal pressure continuous drainage mode: Natural drainage is achieved by utilizing gravity difference. The drainage tube is connected to the monitoring line above the multi-functional interface to dynamically monitor gas flow and carbon dioxide content. This mode is suitable for routine postoperative drainage. The dynamic gas monitoring data can reflect changes in air leakage and lung healing.

[0036] (2) Negative pressure drainage mode: When there is a large amount of pleural effusion or when active acceleration of drainage is required, the negative pressure drainage mode is activated. The electronic gas path valve switches the gas path, connecting the multi-functional interface to a negative pressure source (such as a hospital central negative pressure system or a portable negative pressure pump). Active suction is performed according to the preset negative pressure value (preferred range is -5kPa to -20kPa) to improve drainage efficiency. In negative pressure drainage mode, the gas flow rate and CO2 concentration monitoring functions can be enabled simultaneously or selectively disabled.

[0037] The multi-functional interface allows the device to flexibly adapt to the needs of different drainage stages: in the early stage when there is a lot of gas and liquid accumulation, negative pressure drainage is used to quickly clear it; during the recovery period, normal pressure drainage is used, and gas monitoring data is used to guide the tube removal decision, which improves the integration of product functions.

[0038] Working principle The working process of the device of the present invention is as follows: 1. The diverted material enters the independent water seal chamber of the gas-liquid separation container body through the upstream diversion pipe, the liquid inlet and the water seal pipe. After the liquid level is higher than the overflow port of the water seal chamber, it overflows naturally and is diverted into the liquid collection chamber. 2. The color recognition component continuously and dynamically monitors the color of the drainage fluid; 3. Under the influence of gravity, the liquid settles at the bottom of the container (liquid collection chamber), while the gas rises to the top. In the normal pressure continuous drainage mode, the gas passes through the water seal chamber, the overflow prevention baffle, and the hydrophobic filter before being discharged from the multi-functional interface and supplied to external sensors for analysis. In the negative pressure drainage mode, the electronic gas circuit valve switches the gas circuit, applying negative pressure through this interface to accelerate the drainage. 4. When the color of the drainage fluid changes abnormally (such as turning red or white), the color recognition component outputs a corresponding signal, triggering an alarm on the external monitoring host; 5. When the liquid level reaches the height of the first electrode group (e.g., 80% capacity), a drain prompt is triggered; when the liquid level reaches the height of the second electrode group (e.g., 90% capacity), a forced alarm is triggered, prompting that the liquid must be emptied in time.

[0039] The multi-functional interface described in this invention, along with its internal hydrophobic filter and anti-overflow baffle, is a multi-functional interface designed to meet the requirements for monitoring air leakage and CO2 concentration, as well as negative pressure drainage, during chest drainage.

[0040] When this device is used for abdominal drainage, although monitoring of air leakage and CO2 concentration is not routinely required, the multi-functional interface still has the following clinical significance: (1) As an alternative functional interface: Clinical operators can directly seal the multifunctional interface with a sealing cap or use it as a natural ventilation channel. In this scenario, the gas-liquid separation function, drainage fluid color dynamic recognition function, and graded liquid level alarm function of the present invention are not affected, and can still effectively monitor complications such as postoperative abdominal bleeding, infection, bile leakage, or intestinal fistula.

[0041] (2) Monitoring value for special cases: In special cases such as abdominal cavity infection with gas-producing bacteria, gastrointestinal perforation with gas leakage, or large amounts of residual CO2 that need to be actively discharged after laparoscopic surgery, this multi-functional interface can be connected to an external gas flow sensor or CO2 concentration sensor to provide auxiliary information for clinical assessment of the patient's condition. The reserved design of this interface is part of the modular multi-functional integrated architecture of this invention. Whether or not it is enabled does not affect the realization of the core monitoring purpose of this invention, nor does it depart from the protection scope of this invention.

[0042] Beneficial effects

[0043] Compared with the prior art, the present invention has the following significant advantages: 1. High integration and multi-functional collaboration: The functions of liquid inlet, gas-liquid separation, water seal, gas monitoring (flow rate / CO2), negative pressure suction, graded liquid level electrode sensing, color recognition and bottom drainage are all integrated into a compact transparent container, reducing external pipeline connection points, lowering the risk of leakage and the probability of infection, and realizing the synchronous separation of gas and liquid and multi-parameter monitoring during the drainage process.

[0044] 2. Automated and continuous monitoring of drainage fluid color is achieved: Through the integrated design of color recognition component and gas-liquid separation module, real-time monitoring of drainage fluid color is completed synchronously during the drainage process, eliminating the need for manual visual judgment, eliminating subjective errors, and improving the timeliness and accuracy of monitoring.

[0045] 3. Graded liquid level early warning mechanism: Two sets of vertically arranged electrodes (e.g., 80% and 90% liquid level) are used to realize graded early warning of liquid level, providing clear step-by-step operation guidance for clinical nursing, avoiding misjudgment or delay caused by single threshold alarm, and improving safety and operation convenience.

[0046] 4. Dual-protection gas monitoring channel: The multi-functional interface is equipped with both a hydrophobic filter and an overflow prevention baffle, which can effectively block liquids and aerosols from entering the external sensor, and prevent high-flow gas or foam impact, thus protecting the precision sensor components and improving the reliability and service life of the system.

[0047] 5. Independent constant pressure water seal chamber design: By completely separating the water seal chamber from the collection chamber and setting a constant maximum liquid level, the water seal pressure is ensured to be unaffected by changes in the liquid level in the collection chamber. This avoids the problem of the water seal pressure continuously increasing with the accumulation of liquid in traditional solutions, which can lead to poor drainage or worsening of pneumothorax. This significantly improves the safety and stability of drainage.

[0048] 6. Integrated negative pressure suction and mode switching function: The electronic gas circuit valve enables flexible switching between normal pressure drainage and negative pressure drainage. It can actively accelerate drainage in the negative pressure mode when there is a lot of fluid accumulation in the early postoperative period, and can switch to normal pressure mode to utilize gravity for natural drainage during the recovery period. At the same time, the gas dynamic monitoring capability is retained to guide the extubation decision, which greatly improves the clinical adaptability and drainage efficiency of the device.

[0049] 7. Early warning of complications: Through the preset color-condition mapping relationship and dynamic trend analysis, the system can issue graded warnings in the early stages of complications such as bleeding and infection, winning valuable time for clinical intervention.

[0050] 8. Modular volume design improves clinical applicability: Small volume sizes (e.g., ≤100mL) facilitate bedside installation and rapid response. When used in combination with downstream large-volume drainage bottles, it enables continuous drainage for extended periods without frequent replacements, balancing monitoring sensitivity and clinical convenience. It is suitable for adults, children, and different stages of disease.

[0051] 9. High reusability, reducing usage costs: The monitoring unit (including color recognition sensor, gas flow sensor, electrode terminals, etc.) is reusable, and only disposable drainage tubing consumables need to be replaced, which meets health economics requirements. The passive / active dual-mode design of the color recognition interface balances cost flexibility and clinical adaptability. Attached Figure Description

[0052] Figure 1 This is a schematic diagram of the main body of the gas-liquid separation container described in Embodiment 1 of the present invention. The diagram illustrates the internal structure and functional layout of the main body of the gas-liquid separation container. Figure 2 This is a schematic diagram illustrating the combined use of the gas-liquid separation container body, external monitoring host, and diversion bottle described in Embodiment 2 of the present invention. The diagram illustrates the connection between the present invention and an external monitoring host. Figure 3 This is a schematic diagram of the electrode assembly of the present invention. The figure partially illustrates one embodiment where the electrode assembly is located on the right side of the main body of the gas-liquid separation container. Explanation of the labels in the diagram: Liquid inlet 01, top cover 02, multi-function interface 03, water seal chamber 04, water seal pipe 05, color recognition component 06, overflow prevention partition (0701, 0702), hydrophobic filter device 08, first electrode group (liquid level indication monitoring electrode) 0901, second electrode group (liquid level warning monitoring electrode) 0902, liquid collection chamber 10, bottom drain pipe 11, pipeline shut-off valve 12, external monitoring host 13, color recognition sensor 14, chest drainage tube 15, temperature sensor 16, pressure sensor 17, data cable 18. Detailed Implementation

[0053] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments.

[0054] Example 1: This example provides a modular gas-liquid separation and drainage device with color recognition function, including a gas-liquid separation container body made of transparent medical-grade plastic.

[0055] See Figure 1The container body is equipped with a top cover 02, a liquid inlet 01, and a multi-function interface 03 on its top. The liquid inlet 01 is used to connect to the upstream chest drainage tube 15; the multi-function interface 03 is used to connect to the flow sensor and CO2 sensor of the external monitoring host 13, or to switch to a negative pressure source. A hydrophobic filter 08 and an overflow prevention baffle 0701 or 0702 are installed sequentially on the inside of the multi-function interface 03, forming double protection.

[0056] The interior of the container body is divided into an independent water seal chamber 04 and a liquid collection chamber 10 by a water seal baffle. The water seal pipe 05 extends downward from the liquid inlet 01 to the bottom of the water seal chamber 04. The water seal chamber 04 is designed with a constant maximum liquid level. When the water seal liquid exceeds the overflow port height, it automatically overflows into the liquid collection chamber 10 to ensure a constant water seal pressure.

[0057] The side wall of the liquid collection chamber 10 of the container body is marked with a warning liquid level area. Two sets of electrodes are arranged vertically in this warning liquid level area: the contacts of the first electrode set (liquid level indication monitoring electrode 0901) are located on the inner wall at approximately 80% of the effective volume of the liquid collection chamber, and the contacts of the second electrode set (liquid level warning monitoring electrode 0902) are located on the inner wall at approximately 90% of the effective volume of the liquid collection chamber. The electrode terminals extend beyond the outer wall of the container for connection to the flexible contact interface or magnetic interface of the external monitoring host 13. A bottom drain pipe 11 is provided at the bottom of the container body for draining the drainage fluid into the downstream drainage bottle. In an embodiment of the container body used independently, a pipeline shut-off valve 12 may also be provided on the bottom drain pipe 11.

[0058] A color recognition component 06 is provided upstream of the liquid inlet 01 of the container body. This component is a light-transmitting window (e.g., an optical glass tube) used to couple with a color recognition sensor 14 provided on the external monitoring host 13. When the drainage fluid flows into the container body, the external color recognition sensor 14 collects the color information of the drainage fluid through the light-transmitting window of the color recognition component 06.

[0059] In this embodiment, the gas-liquid separation container has a capacity of 30 mL and can be used as an independent drainage device for short-term drainage or for pediatric patients.

[0060] Example 2: This example provides a combination system of a modular gas-liquid separation and drainage device with color recognition function, an external monitoring host 13, and a large-capacity drainage bottle.

[0061] See Figure 2The inlet 01 of the gas-liquid separation container is connected to the upstream drainage pipeline. The multi-functional interface 03 of the container body is connected to an external monitoring host 13 via a pipeline. This host integrates a gas flow sensor and a CO2 sensor. The color recognition sensor 14 is coupled through a color recognition component 06 on the container body to collect drainage fluid color data. Downstream of the multi-functional interface 03 is an electronic gas path valve, which is electrically connected to the central processing unit of the external monitoring host 13, used to switch between atmospheric pressure drainage mode and negative pressure drainage mode. The color recognition sensor 14, either built into or external to the external monitoring host 13, collects drainage fluid color data through the color recognition component 06 on the container body.

[0062] The bottom drain pipe 11 of the container body is connected to a large-capacity drainage bottle with a capacity of 1000 mL for collecting and storing drainage fluid. A pipeline shut-off valve 12 is installed on the bottom drain pipe 11 to control the flow of drainage.

[0063] The external monitoring host 13 contains a central processing unit, which is electrically connected to the color recognition sensor 14, the gas flow sensor, the CO2 sensor, the electronic gas valve, and the liquid level indication monitoring electrode 0901 and the liquid level warning monitoring electrode 0902. The central processing unit is configured to execute the following control logic: - Continuously receive signals from the color recognition sensor 14 and analyze the RGB values ​​of the drainage fluid color; - When the red component of the drainage fluid is significantly increased and exceeds the preset threshold, it is determined to be active bleeding and an advanced alarm is triggered. - When the color of the drainage fluid tends to be milky white or yellow and is accompanied by increased turbidity, it is determined to be an infection and triggers a medium-level alarm; - When the drainage fluid color is normal, record the color data and upload it to the hospital information system; - Continuously receive on / off signals from the liquid level indicator monitoring electrode 0901 and the liquid level warning monitoring electrode 0902: When the liquid level indicator monitoring electrode 0901 is turned on, a "high liquid level, prompt to empty" signal is issued; when the liquid level warning monitoring electrode 0902 is turned on, a "very high liquid level, must be emptied in time" forced alarm signal is issued. - According to clinical settings or user instructions, control the electronic gas path valve to switch working modes: In normal pressure drainage mode, multi-function interface 03 is connected to the gas flow sensor and CO2 sensor; in negative pressure drainage mode, the electronic gas path valve switches the gas path, so that multi-function interface 03 is connected to the negative pressure source to start negative pressure suction.

[0064] The preferred color recognition sensor 14 is the TCS34711FN, which has high sensitivity and good color reproduction.

[0065] Preferably, to improve functional integration, the thoracic or abdominal drainage tube can be combined with the modular gas-liquid separation drainage device to form a single consumable.

[0066] Furthermore, based on the above configuration, temperature and pressure measurement functions are also introduced. Specifically, the thoracic or abdominal drainage tube is prepared as a three-cavity system: a drainage cavity, a pressure measurement cavity, and a temperature measurement cavity (with temperature sensors and wires installed). The temperature sensor 16 is located at the tip of the thoracic or abdominal drainage tube, and the pressure sensor is connected to the inside of the drainage tube. The temperature sensor 16 and pressure sensor 17 are connected to an external monitoring host 13 via a data cable 18 to dynamically monitor temperature and pressure changes within the thoracic and abdominal cavities.

[0067] Example 3: Method for setting up the electrode assembly In this invention, both the liquid level indicator monitoring electrode 0901 (first electrode group) and the liquid level warning monitoring electrode 0902 (second electrode group) adopt the contact conductivity liquid level detection principle. Their basic working mechanism is as follows: using the drainage fluid (usually a body fluid containing electrolytes and possessing a certain degree of conductivity) as a conductive medium, when the liquid level rises to the installation height of a certain electrode group, the liquid will conduct electricity between that electrode group and the external common electrode (or between the two electrodes within the electrode group), forming an electrical circuit, thereby generating an on / off signal. This signal is transmitted via an external wire to the central processing unit of the external monitoring host 13, triggering a corresponding indicator or alarm.

[0068] Each electrode group contains at least two electrode contacts (i.e., positive and negative terminals, or signal and common terminals). When the liquid level rises to the height of that electrode group, the conductive drainage fluid simultaneously submerges both contacts, causing a sharp drop in the resistance between them, thus forming a conductive circuit. The external monitoring host 13 can accurately determine the current liquid level range by continuously monitoring the continuity of each electrode group circuit.

[0069] To prevent false triggering of a single electrode group 0901 due to factors such as drainage fluid foam or liquid surface fluctuations, the central processing unit of the external monitoring host 13 can be set to a continuous conduction time threshold (e.g., continuous conduction for no less than 1 second) before it is considered a valid signal, thereby improving the reliability of detection.

[0070] I. Structural Layout of Electrode Assembly 1. Vertical arrangement and height setting See Figure 3 The first electrode group 0901 and the second electrode group 0902 are arranged sequentially along the vertical direction on the inner wall of the gas-liquid separation container body, as follows: - First electrode group (liquid level indicator monitoring electrode 0901): Located on the inner wall of the container at approximately 80% of its effective volume. When the liquid level in the collection chamber 10 rises to this height, the first electrode group 0901 is activated, and an external device sends a "high liquid level, prompt to empty" signal.

[0071] - Second electrode group (liquid level warning monitoring electrode 0902): Located on the inner wall of the container at approximately 90% of its effective volume, above the first electrode group 0901. When the liquid level continues to rise to this height, the second electrode group 0902 is activated, and external equipment issues a mandatory alarm signal stating "liquid level is extremely high, it must be emptied immediately".

[0072] A certain longitudinal distance is maintained between the two sets of electrodes (preferably 10mm to 20mm, depending on the internal volume) to ensure that the two sets of electrodes are turned on sequentially during the liquid level rise, thus realizing the gradient warning function. If the distance is too small, the two sets of electrodes may turn on simultaneously when the liquid level fluctuates, losing the effect of graded warning; if the distance is too large, it may reduce the effective volume utilization rate of the liquid collection chamber.

[0073] 2. Electrode fixing method The electrode contacts (sensing terminals) of each set of electrodes are set on the inner wall surface of the gas-liquid separation container body, while the electrode wiring terminals extend to the outer wall of the container; the electrode wiring terminals are connected to the elastic contacts of the external monitoring host 13 through the external monitoring host 13, and communication with the external monitoring host 13 is realized.

[0074] The specific fixing method can adopt any of the following implementation schemes: Option 1 (Embedded Fixing): A mounting hole penetrating the wall thickness is pre-set at a corresponding position on the side wall of the gas-liquid separation container. After the electrode contact passes through the mounting hole, its end is flush with or slightly protrudes from the inner wall of the container (the protrusion height does not exceed 1mm). The electrode and the mounting hole are sealed with medical-grade sealant or a sealing ring to prevent leakage of the drainage fluid. The electrode terminal extends out of the outer wall of the container, protruding 0.2mm, to facilitate effective contact with the elastic contacts of the external monitoring host 13.

[0075] Option 2 (PCB Substrate Fixing): Two electrode contacts at the same liquid level are positioned on the same side surface of a single elongated printed circuit board (PCB), arranged in a parallel, spaced-apart configuration. This PCB substrate is vertically fixed along the inner wall of the container, with the electrode contacts facing inwards. The PCB substrate also features conductive lines electrically connected to each electrode contact and external interfaces. The back side of the PCB substrate is attached to the inner wall of the container. The advantages of this option are high integration and ease of installation.

[0076] Option 3 (Electrode Holder Fixation): Each group of electrodes is installed using an independent electrode holder. The electrode holder has a cavity inside, and the electrode probe passes through the middle of the electrode holder, insulating sleeve, and clamping sleeve. A sealing gasket and locking nut are used to achieve a secure fixation. This option is safe, reliable, easy to install, and provides excellent sealing.

[0077] 3. Layout of two contacts within the same group of electrodes Two electrode contacts within the same electrode group are arranged at the same horizontal height on the inner wall of the container, with a preferred horizontal distance of 2mm to 15mm. Too small a distance (less than 2mm) may cause residual liquid or foam to cover the surfaces of the two electrodes, resulting in false triggering; too large a distance may cause a decrease in detection sensitivity due to liquid surface tension or localized air bubbles. The two contacts can be symmetrically arranged on both sides of the container's radial direction, or they can be arranged at adjacent positions on the same side wall of the container.

[0078] II. Selection of Electrode Materials Since this invention pertains to a medical device, the electrode material must simultaneously meet multiple requirements, including conductivity, biocompatibility, corrosion resistance, and long-term stability. The following materials are preferred: 1. Electrode contact (sensing terminal) material - Medical-grade stainless steel (such as 316L stainless steel): It has good corrosion resistance and mechanical strength, and is chemically stable in bodily fluid environments. It is a widely used conductive material in medical devices. Its cost is relatively low, making it suitable for disposable consumables.

[0079] - Platinum (Pt) or Platinum-Iridium Alloy: Platinum is a chemically stable precious metal with excellent electrical conductivity. It exhibits minimal corrosion or ion release within the body and demonstrates excellent biocompatibility. Platinum-iridium alloys are stable in blood and tissue fluids over long periods, without triggering significant toxicity or immune responses. The smooth electrode surface prevents blood components from adhering, reducing the tendency for thrombosis. This material is suitable for applications requiring long-term or repeated use.

[0080] Titanium: It has excellent corrosion resistance, low specific gravity, and excellent biocompatibility with biological tissues, making it an ideal biomedical material.

[0081] 2. Insulation and sealing materials All parts of the electrodes, except for the contacts, must be insulated to prevent unintended electrical conduction or short circuits. - Insulating substrate (e.g., PCB solution): FR-4 epoxy fiberglass board or ceramic substrate, which has good insulation properties and mechanical strength.

[0082] - Insulating sleeve: Made of medical-grade polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK) or silicone rubber, etc., to cover the non-inductive parts of the electrode, ensuring that only the electrode contacts are exposed to the drainage fluid.

[0083] - Sealing materials: The installation gap between the electrode and the container wall is sealed with medical-grade silicone rubber sealing rings or epoxy resin sealant to ensure the airtightness and liquid tightness of the container.

[0084] 3. Conductive circuit materials The wires connecting the electrode terminals to the external monitoring host 13 are made of medical-grade silver-plated copper wire or copper foil, and are covered with an insulation layer (such as polyvinyl chloride or polytetrafluoroethylene insulation layer) to ensure the stability of signal transmission and electrical safety.

[0085] Example 4: Operating Mode Switching Control This embodiment details the operating mode switching control logic of the electronic pneumatic valve.

[0086] The central processing unit of the external monitoring host 13 controls the electronic gas path valve to switch between the following two modes according to clinical settings or user manual commands: (1) Atmospheric pressure continuous drainage mode: The electronic gas circuit valve connects the multi-function interface 03 to the gas analysis pipeline where the gas flow sensor and CO2 sensor are located, while disconnecting the negative pressure source. The end of the drainage tube is connected to the outside atmosphere (a water seal is established through the water seal pipe), and natural drainage is achieved by utilizing the gravity difference. Gas flow and CO2 concentration data are continuously collected and transmitted to the central processing unit for analysis and recording.

[0087] (2) Negative pressure drainage mode: When the user selects the negative pressure drainage mode through the human-machine interface of the external monitoring host 13, or when the central processing unit automatically triggers the switch according to preset conditions (such as continuously monitoring that the drainage fluid volume is lower than the preset threshold and the gas leakage is continuously high), the electronic gas circuit valve will activate, connecting the multi-function interface 03 to the negative pressure source pipeline, while selectively closing or maintaining the connection of the gas analysis pipeline. The central processing unit controls the start and stop of the negative pressure pump or the opening of the regulating valve according to the preset negative pressure value (preferably within the range of -5kPa to -20kPa) to maintain stable negative pressure suction. In negative pressure drainage mode, the gas flow rate and CO2 concentration monitoring functions can be activated simultaneously (if the gas circuit design allows for simultaneous operation) or selectively closed.

[0088] This mode-switching system allows the device to flexibly adapt to the needs of different drainage stages: in the early postoperative period when there is a large amount of fluid and air accumulation, negative pressure drainage is used to quickly clear the fluid and promote lung re-expansion; during the recovery period, normal pressure drainage is used, and gas monitoring data is used to assess air leakage and guide extubation decisions.

[0089] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A gas-liquid separation and diversion module integrating multiple functional interfaces and a liquid level sensor, characterized in that, It includes the main body of the gas-liquid separation container, a multi-functional interface (03) disposed thereon, and a liquid level sensor; The gas-liquid separation container is made of transparent medical-grade plastic. The interior is divided into multiple chambers, including at least an independently set water seal chamber (04) and a liquid collection chamber (10), by a water seal partition. The gas-liquid separation container body integrates the following functional structures from top to bottom: (1) Top functional area: - Top cover, used to ensure the airtightness of the entire gas-liquid separation container body during operation; - Inlet (01), located on the top or side of the container, is used to connect with the upstream drainage line to receive drainage from the patient's pleural or abdominal cavity; - A multi-function interface (03) is located on the top of the container and is used to communicate with the gas flow sensor and / or carbon dioxide concentration sensor of the external drainage monitoring host (13), while also being able to switch to a negative pressure source; - A hydrophobic filter (08) is disposed inside the multifunctional interface (03) for intercepting liquids and aerosols while allowing gas to pass through; - Overflow prevention baffles (0701, 0702) are installed on the top of the container to prevent liquid splashing or foam from entering the gas monitoring pipeline during negative pressure suction; (2) Central functional chamber: - A water seal pipe (05) is connected to the liquid inlet (01) and extends downward from the liquid inlet (01) to the bottom of the water seal chamber (04); - Independent water seal chamber (04), which is an independent chamber formed by the water seal baffle and the liquid collection chamber (10). The lower end of the water seal pipe (05) extends into the bottom of the chamber. The water seal chamber (04) is designed with a constant maximum water seal liquid level. When the water seal liquid exceeds the overflow port height, it automatically overflows to the liquid collection chamber (10). - The liquid collection chamber (10), which is a separate chamber formed by a water seal partition, is used to temporarily store the drained liquid; (3) Bottom drainage and monitoring area: - Bottom drain pipe (11), located at the bottom of the collection chamber (10), is used to drain the collected drainage fluid into the downstream drainage fluid collection container; - Liquid level indicator monitoring electrode (first electrode group) (0901), which is set in the liquid level indicator emptying area on the inner wall of the liquid collection chamber (10); - Liquid level warning monitoring electrode (second electrode group) (0902), which is set in the warning liquid level area on the inner wall of the liquid collection chamber (10); The multi-functional interface (03) is equipped with an electronic gas valve downstream, which is used to switch between the "gas monitoring" working mode and the "negative pressure drainage" working mode.

2. The gas-liquid separation and diversion module integrating multiple functional interfaces and a liquid level sensor according to claim 1, characterized in that, The overflow prevention baffles (0701, 0702) are located on the upstream side of the hydrophobic filter device (08) and are used to block large-diameter droplets and foam in advance when the negative pressure is attracted or when there is a lot of foam in the drainage liquid, so as to reduce the liquid load of the hydrophobic filter device (08); the overflow prevention baffles (0701, 0702) and the hydrophobic filter device (08) form a dual protection mechanism.

3. The gas-liquid separation and diversion module integrating multiple functional interfaces and a liquid level sensor according to claim 1, characterized in that, The liquid level indicator monitoring electrode (first electrode group) (0901) is located at 75% to 80% of the effective volume of the liquid collection chamber (10) at the liquid level height; the liquid level warning monitoring electrode (second electrode group) (0902) is located at 85% to 90% of the effective volume of the liquid collection chamber (10) at the liquid level height. The first electrode group (0901) and the second electrode group (0902) are arranged sequentially in the vertical direction to form a graded liquid level early warning mechanism.

4. The gas-liquid separation and diversion module integrating multiple functional interfaces and a liquid level sensor according to claim 1, characterized in that, The liquid level sensor also employs any of the following alternatives: - An infrared photoelectric liquid level sensor, in which an infrared light-emitting diode and a photosensitive receiver are installed on the outer wall of the gas-liquid separation container body at the warning liquid level; - A capacitive liquid level sensor, wherein a capacitive detection electrode is provided on the outer wall of the gas-liquid separation container body at the warning liquid level; - An ultrasonic liquid level sensor is located directly above the top cover (02) and measures the liquid level by emitting ultrasonic waves, receiving echoes, and calculating flight time.

5. A gas-liquid separation and diversion module integrating multiple functional interfaces and a liquid level sensor according to claim 1, characterized in that, It also includes a color recognition component (06), which is disposed in the transparent area of ​​the outer wall between the liquid inlet (01) and the water seal chamber (04) for coupling with the color recognition sensor (14) of the external monitoring host (13), or is integrated with an independent color recognition sensor (14) module; The color recognition component (06) is configured to dynamically monitor the color change of the drainage fluid when the drainage fluid flows through the gas-liquid separation container body, and output a recognition signal according to the preset color-condition mapping relationship.

6. The color recognition component (06) according to claim 5, characterized in that, The color recognition component (06) includes one of the following two implementation schemes: - Option 1: A light-transmitting window or color recognition area is provided on the outer wall of the container body for coupling with the color recognition sensor (14) provided on the external monitoring host (13); - Option 2: A color recognition sensor (14) module is fixedly installed on the outer wall of the container body. The module includes a color sensor, a signal processing circuit and an external interface, which is used to collect the color data of the drainage fluid in real time and output it to the outside through the external interface.

7. The color recognition component (06) according to claim 5, characterized in that, The color recognition component (06) is also configured to make a diagnosis based on the changing trend of the drainage fluid color: - When the color of the drainage fluid tends to be red and the red component is significantly increased and exceeds the preset threshold, an active bleeding risk is indicated, triggering an advanced alarm; - When the color of the drainage fluid tends to be milky white or yellow and is accompanied by increased turbidity, it indicates a risk of infection and triggers a medium-level alarm; - When the color of the drainage fluid tends to be dark green or brownish, it may indicate bile leakage or intestinal fistula; - When the color of the drainage fluid is within the preset normal range, record the color data and upload it to the hospital information system.

8. The gas-liquid separation and diversion module according to claim 1, characterized in that, The gas-liquid separation container body is prepared in various specifications, including small capacity specifications with a capacity of ≤100mL, medium capacity specifications with a capacity of ≥200mL, or large capacity specifications with a capacity of ≥400mL. The small-capacity gas-liquid separation container body is used in combination with the downstream large-capacity drainage bottle through the bottom drain pipe (11). The large-capacity drainage bottle is connected to the bottom drain pipe (11) of the gas-liquid separation container body through a pipeline. The gas-liquid separation container body and the large-capacity drainage bottle are detachably connected via a quick connector.

9. The gas-liquid separation and diversion module according to claim 1, characterized in that, The electronic gas valve is electrically connected to the central processing unit of the external monitoring host (13), and can automatically or manually switch between the following two working modes according to clinical needs: - Normal pressure continuous drainage mode: Natural drainage is achieved by utilizing gravity difference. The drainage tube is connected to the monitoring pipeline above the multi-functional interface (03) to dynamically monitor the gas flow rate and carbon dioxide content. - Negative pressure drainage mode: The electronic air circuit valve switches the air circuit, so that the multi-functional interface (03) is connected to the negative pressure source, and actively suctions according to the preset negative pressure value; The preferred range for the negative pressure value is -5 kPa to -20 kPa.

10. The gas-liquid separation and diversion module according to claim 1, characterized in that, Each set of liquid level indicator monitoring electrodes (0901) and liquid level warning monitoring electrodes (0902) contains at least two electrode contacts, namely positive and negative electrodes or signal electrode and common electrode. When the liquid level rises to the height of the set of electrodes, the conductive drainage liquid simultaneously submerges the two contacts to form a conductive circuit. The electrode terminals extend to the outer wall of the container for connection with the elastic contact interface or magnetic interface of the external monitoring host (13).

11. The gas-liquid separation and diversion module according to claim 3, characterized in that, The longitudinal distance between the first electrode group (0901) and the second electrode group (0902) is 10mm to 20mm; the two electrode contacts in the same electrode group are arranged at the same horizontal height on the inner wall of the container, with a horizontal distance of 2mm to 15mm between them; the electrode contacts are flush with or protrude no more than 1mm from the inner wall of the container, and the electrode terminals protrude 0.2mm from the outer wall of the container.

12. The gas-liquid separation and diversion module according to claim 1, characterized in that, The constant maximum water seal liquid level of the water seal chamber (04) is set by the overflow port height. The upper limit of the water seal liquid level is set to 3-6cm. When the water seal liquid exceeds 3-6cm, it automatically overflows to the liquid collection chamber (10).

Images