A closed-loop feedback multifunctional negative pressure drainage management system and disengagement control method

Abstract

The application discloses a closed-loop feedback multifunctional negative pressure drainage management system and a disengagement control method, and belongs to the technical field of medical devices. The system comprises a host, a tank assembly and a drainage tube. A closed-loop pressure feedback mechanism is formed by a non-contact optical monitoring subsystem. A pressure sensing medium is arranged on the tank assembly, and a photoelectric detection device is arranged on the host and is aligned with the medium. The pressure is monitored in real time by identifying the change in the optical characteristics of the medium, and the output of a negative pressure generating unit is adjusted by a control unit, so that stable closed-loop control of the negative pressure at the wound end is realized. An infrared spectrum sensor of the system is used for real-time component analysis of the drainage liquid in the tank. An intelligent disengagement mode is used for judging tissue incarceration by negative pressure test, and then safely releasing the incarceration by controllable pulse positive pressure airflow. The system realizes high-precision adaptive control of drainage pressure, real-time monitoring and early warning of the properties of the drainage liquid, and safe and intelligentization of the tube extraction operation, and solves the problems of pressure attenuation, monitoring lag and high operation risk of traditional devices.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a drainage system capable of precise pressure control and fluid property analysis, particularly a closed-loop feedback multifunctional negative pressure drainage management system and a de-embedding control method. Background Technology

[0002] Surgical drainage is a crucial medical step in postoperative treatment and trauma recovery. Its main function is to drain accumulated blood, fluid, pus, and necrotic tissue from body cavities, joint cavities, or deep wounds, thereby eliminating dead space, promoting tissue healing, and reducing the risk of infection.

[0003] Currently, drainage devices widely used in clinical practice are mainly divided into two categories: passive drainage and active drainage. Among them, the most common passive drainage device is the negative pressure drainage ball. For example, a measurable negative pressure drainage system disclosed in Chinese Patent Publication No. CN208809167U works by using the physical rebound force of an elastic ball after compression to generate negative pressure and achieve drainage. However, such purely mechanical devices have inherent physical defects: the negative pressure decay is uncontrollable. As drainage fluid accumulates, the ball's rebound amplitude gradually decreases, and the negative pressure value shows a non-linear decay trend, making it impossible to maintain a constant effective drainage negative pressure. In addition, there is a lack of monitoring methods. Medical staff cannot know the real pressure exerted on the wound by the end of the drainage tube in real time and can only squeeze the ball based on experience. This can easily lead to incomplete drainage due to insufficient negative pressure or aspiration damage to surrounding normal tissue due to excessive negative pressure.

[0004] To address the issue of unstable negative pressure, existing technologies attempt to incorporate electronic monitoring into drainage systems. For example, Chinese patent application publication number CN110464891A discloses a negative pressure drainage monitoring device that integrates a pressure sensor, a flow sensor, and a solenoid valve to monitor the drainage process. However, this technical solution still has limitations in practical applications: Although the device incorporates electronic monitoring, its negative pressure source still relies on a traditional elastic negative pressure bulb. The inherent elastic decay characteristics of the bulb prevent it from providing stable negative pressure. The solenoid valve can only regulate downstream on / off states or flow rates, but cannot provide real-time compensation or closed-loop control for the decay of the negative pressure source itself. This results in fluctuations in the effective negative pressure applied to the wound. This semi-open-loop control method based on flow monitoring is a pseudo-closed-loop control, unable to achieve full closed-loop constant pressure control of the actual pressure at the wound end. Furthermore, there is an irreconcilable conflict between the sensor and consumables. To obtain accurate data, the sensor needs to contact the fluid, leading to excessively high costs for disposable consumables. Placing the sensor on the main unit requires a complex isolation structure to prevent cross-infection and makes it difficult to accurately report pressure changes at the distal end, i.e., the tank end.

[0005] Furthermore, assessing the characteristics of drainage fluid is crucial for determining a patient's postoperative recovery, such as whether internal bleeding or infection has occurred. Chinese patent application publication number CN115364293A discloses a multifunctional auxiliary device for negative pressure irrigation, which assesses the patient's exudate by calculating the flow difference between the irrigation fluid and the drainage fluid, and incorporates a rotating collection rack for time-segmented sample collection. The drawback of this technology is the lack of in-situ analysis capabilities. It focuses on managing the volume of drainage fluid and collecting physical samples, but cannot achieve real-time, in-situ optical analysis of drainage fluid components such as hemoglobin, pus cells, and fibrin. This results in poor timeliness; medical staff still need to send the collected samples to the laboratory for biochemical testing, leading to a significant time delay. It cannot trigger alarms within the golden timeframe for postoperative bleeding or infection, thus failing to provide an immediate response to sudden changes in blood quality or signs of infection during or after surgery.

[0006] Finally, drainage tube blockage and tissue entrapment are the most challenging safety issues in long-term drainage. Chinese patent application publication number CN118453979A discloses a multifunctional medical negative pressure drainage device that uses an elastic membrane to sense pressure differences and triggers liquid flushing upon blockage. While it provides an anti-blockage approach, it still has the following shortcomings: its core mechanism is a reactive, post-hoc remedial measure, meaning flushing is only initiated after blockage has formed, causing pressure imbalance and exceeding a threshold, lacking a predictive mechanism based on pressure decay trends.

[0007] Furthermore, for tissue impingement caused by omentum or soft tissue adhesion, blindly performing high-pressure fluid irrigation not only fails to dislodge the tissue but may also cause tissue edema or spread of infection due to retrograde hydraulic pressure. At the end of drainage treatment, the side holes of the drainage tube may become impinged by newly formed granulation tissue such as the omentum; rough removal of the tube can easily lead to tissue damage and bleeding. Currently, clinical practice relies entirely on the doctor's technique and experience, posing a risk of secondary injury to the patient and presenting significant patient safety risks and operational uncertainties.

[0008] In summary, existing negative pressure drainage technologies still have significant technological gaps in achieving low-cost, high-precision monitoring, real-time analysis of fluid properties, and safe tissue dislodgement. Therefore, there is an urgent need to develop a multifunctional negative pressure drainage management system that can monitor pressure non-contactly, possess spectral analysis capabilities, and intelligently identify and pneumatically dislodge tissue fragments. Summary of the Invention

[0009] The problem this invention aims to solve is the shortcomings of existing technologies. This invention provides a closed-loop feedback multifunctional negative pressure drainage management system and a de-embedding control method, which aims to solve the defects of existing negative pressure drainage devices, such as uncontrollable negative pressure attenuation, difficulty in balancing monitoring cost and accuracy, lag in drainage fluid property analysis, and the risk of tissue damage during tube removal.

[0010] To address the aforementioned problems, this invention provides a closed-loop feedback multifunctional negative pressure drainage management system, comprising: a main unit integrating a control unit, a negative pressure generating unit, and a sensor assembly; a tank assembly, a rigid, fixed-volume cavity for collecting drainage fluid and detachably connected to the main unit; a drainage tube, one end of which is implanted into the patient's body, and the other end connected to the tank assembly via a tubing fluid path; the management system has a closed-loop pressure feedback mechanism, wherein the main unit adjusts the output power of the negative pressure generating unit in real time based on monitored pressure data; the closed-loop pressure feedback mechanism includes a non-contact optical monitoring subsystem, which includes a pressure-sensing medium disposed on the tank assembly, the pressure-sensing medium changing its optical properties according to changes in the pressure it receives; the main unit is equipped with a photoelectric detection device, which, when the tank assembly is connected to the main unit, aligns with the pressure-sensing medium, identifies changes in its optical properties in real time, and converts them into pressure signals that are transmitted to the control unit.

[0011] Preferably, the management system further includes a real-time fluid property monitoring subsystem. At least a portion of the tank assembly is made of a light-transmitting material. An infrared spectral sensor is mounted on the main unit and positioned outside the light-transmitting area of ​​the tank assembly. The infrared spectral sensor emits infrared light into the drainage fluid within the tank assembly and receives transmitted or reflected light. By analyzing the absorption rate of the drainage fluid to specific wavelengths of light, the system identifies the composition of the drainage fluid, which includes at least one or more of plasma, whole blood, exudate, and pus. By integrating the infrared spectral sensor into the main unit and utilizing the light-transmitting tank for in-situ non-destructive testing, the system can complete an optical scan of the components the instant the drainage fluid flows into the tank. This represents a fundamental shift from sample delivery to bedside real-time monitoring, enabling healthcare professionals to immediately detect postoperative changes in blood quality or signs of infection, providing crucial real-time data support for early clinical intervention and significantly improving the timeliness of complication warnings.

[0012] Preferably, the main unit also integrates a pressure generating unit and a pressure switching unit; the control unit is configured to have a disengagement mode, in which the control unit controls the pressure switching unit and the pressure generating unit to output pulsed positive pressure airflow into the drainage tube to release tissue impingement in the side hole of the drainage tube. By integrating positive pressure generation and switching functions and preset disengagement mode, this invention transforms high-risk, experience-based manual operation into standardized, programmed pneumatic mechanical operation. Compared with the passive, potentially ineffective, or even harmful liquid flushing anti-clogging mechanisms in the prior art, pulsed positive pressure airflow can act directly on the interface of the impinged tissue with more controllable mechanical force, avoiding tissue edema or infection spread that may be caused by liquid backflow, providing a new and superior technology for safe tube removal.

[0013] Preferably, when executing the dislodgement mode, the control unit performs the following control logic: before outputting positive pressure airflow, it controls the negative pressure generating unit to perform a negative pressure test; it determines whether there is embedding by monitoring the negative pressure decay rate in the drainage tube; if embedding is determined, it outputs a pulsed positive pressure airflow with a set peak value and monitors pressure mutation signals in real time to determine whether the tissue has dislodged. This further optimizes the dislodgement process. First, the pre-tested negative pressure intelligently diagnoses the embedding state, changing the crude mode of existing technologies that rely solely on a single pressure threshold to trigger a response, making intervention more targeted and necessary. Second, the entire dislodgement process forms an intelligent closed loop based on pressure feedback: the system not only executes actions but also dynamically evaluates the dislodgement effect (i.e., whether the tissue has been dislodged) by monitoring pressure mutation signals in real time, and decides on subsequent operations accordingly. This achieves an intelligent upgrade from blind execution to perception, judgment, execution, and then perception, significantly improving the safety and success rate of the operation.

[0014] Preferably, the tank assembly is equipped with a gas-liquid isolation mechanism. This mechanism includes a piston fixing hole, a sealing piston, and a pressure-stabilizing spring damper, all located within the tank shell. The sealing piston is slidably installed within the piston fixing hole, and the pressure-stabilizing spring damper abuts against the bottom of the sealing piston to buffer pressure fluctuations and prevent the sealing piston from blocking the negative pressure extraction port. The sealing piston achieves reliable physical gas-liquid separation, strictly isolating the drainage fluid within the disposable tank, fundamentally eliminating the risk of cross-infection and protecting the core gas path of the main unit. The introduction of the pressure-stabilizing spring acts as a mechanical buffer, absorbing sudden pressure changes within the tank caused by sudden liquid accumulation or changes in body position. This provides time for the main unit's electronic closed-loop control system to respond. Combined with electronic control, this forms a dual pressure-stabilizing mechanism of mechanical buffering and electronic fine-tuning, making the pressure control of the entire system more stable and reliable.

[0015] Preferably, the closed-loop pressure feedback mechanism further includes a pressure sensor at the air pressure monitoring port located inside the main unit. This pressure sensor is connected to the air pressure monitoring channel inside the drainage tube via a pressure monitoring pipeline, directly monitoring the actual pressure at the end of the drainage tube. The control unit combines the pressure signal from the photoelectric detection device and the pressure signal from the pressure sensor at the air pressure monitoring port to perform dual verification and adjustment of the drainage negative pressure. By adding an independent pressure sensor at the air pressure monitoring port to directly measure the pressure at the wound end and fusing and verifying it with the non-contact optical pressure signal from the canister end, the control system can accurately identify and distinguish whether pressure fluctuations originate from changes at the wound end or the pipeline end. This dual-redundant verification mechanism greatly improves the system's perception accuracy and control reliability regarding the true and effective therapeutic negative pressure.

[0016] Preferably, the pressure-sensing medium is a pressure-sensitive color-changing film, which is attached to the inner wall of the tank assembly; the photoelectric detection device is an infrared photoelectric sensor used to identify the color change of the pressure-sensitive color-changing film. As a mature physical sensing material, the pressure-sensitive color-pressure correspondence is stable and can be calibrated in batches. The infrared photoelectric sensor can accurately and interference-resistantly identify color changes. This combination transforms the complex pressure sensing problem into a simple optical color recognition problem, perfectly realizing the design concept of separating precision sensing elements from disposable consumables, reducing the cost per use while ensuring monitoring accuracy.

[0017] Preferably, the system also includes a T-joint assembly connected between the tank assembly and the drain pipe. The T-joint assembly integrates a waterproof bacterial filter membrane for connecting to the air pressure monitoring interface of the main unit, preventing liquid from entering the main unit. This eliminates the risk of liquid contamination of the air pressure monitoring pipeline. The T-joint assembly integrates a waterproof and breathable membrane, which allows air pressure to be transmitted to the main unit sensor without damage while absolutely blocking the passage of liquids, bacteria, and aerosols. This provides another robust physical barrier for the clean monitoring air path inside the main unit, working in conjunction with the gas-liquid isolation mechanism inside the tank to form a double layer of protection, greatly enhancing the long-term safety and reliability of the system.

[0018] Preferably, the host and the tank assembly are physically connected and fixed by a magnetic attraction structure; the magnetic attraction structure includes a host magnetic ring disposed on the host and a tank magnetic ring disposed on the tank assembly.

[0019] Preferably, the intelligent dislodgement control method of the multifunctional negative pressure drainage management system with closed-loop feedback includes the following steps: real-time monitoring of the pressure and flow status within the drainage tube; when an abnormal pressure increase is detected and its duration exceeds a preset threshold, and spectral analysis does not indicate a bleeding risk, a flushing alarm is issued; upon receiving a tube removal command, the system enters the dislodgement mode, and a pre-tested micro-negative pressure test is performed to determine whether tissue entrapment has occurred in the drainage hole; if entrapment is determined, a controlled pulsed positive pressure airflow is automatically generated and blown into the drainage tube until a sharp drop in pressure is detected, confirming tissue dislodgement. This achieves multifunctional linkage and intelligent decision-making; in the blockage warning stage, pressure trends and spectral analysis results are cross-validated, avoiding false alarms that may occur in existing technologies due to the inability to distinguish the nature of blockages. In the dislodgement stage, a complete automated closed-loop process is defined from testing and diagnosis to pulse therapy and effect verification. This method integrates the advantages of each subsystem of the present invention into a holistic intelligent solution, improving the standardization and safety of clinical operations.

[0020] Compared with the prior art, the present invention achieves the following beneficial technical effects: This invention achieves high-precision, adaptive, fully closed-loop constant pressure drainage control, constructing a closed-loop control architecture based on dual-path pressure feedback. One path directly senses the actual pressure at the wound end through a pressure monitoring channel within the drainage tube; the other path indirectly but accurately senses the pressure inside the canister at extremely low cost through a non-contact optical monitoring subsystem. The control unit fuses and verifies these two signals, dynamically adjusting the output power of the negative pressure generating unit, thereby enabling real-time compensation for pressure fluctuations caused by changes in tubing resistance, drainage fluid inflow, or any other factor. Compared to existing technologies that rely on unstable negative pressure sources or only regulate downstream flow, this invention truly achieves fully closed-loop, adaptive constant pressure control targeting a set negative pressure value, significantly improving the stability and safety of drainage treatment.

[0021] This invention resolves the conflict between precision pressure monitoring and the cost of disposable consumables in a low-cost manner. It incorporates a pressure-sensing medium on the tank assembly to convert pressure signals into optical signals, and a corresponding photoelectric detection device on the main unit for non-contact reading. This main unit sensing, consumable display architecture retains expensive precision sensing elements in a reusable main unit, while placing the pressure-sensitive optical medium on a low-cost disposable tank. This not only significantly reduces the cost of consumables per use but also completely avoids the risk of cross-infection and the challenges of cleaning and disinfection caused by sensor contact with bodily fluids, achieving excellent cost control and economy while ensuring high-precision monitoring.

[0022] This invention enables real-time, in-situ, non-invasive optical analysis of drainage fluid components, significantly improving the timeliness of complication early warning. By utilizing the light-transmitting properties of the canister components and integrating an infrared spectral sensor, this invention can perform real-time spectral scanning and analysis of the drainage fluid flowing into the canister during the drainage process. The system can instantly identify changes in key components of the drainage fluid, such as distinguishing between whole blood, plasma, exudate, or pus. This allows medical staff to detect delayed postoperative bleeding or early signs of infection at the bedside, transforming the traditional post-operative laboratory testing model into real-time pathological monitoring and early warning, thus gaining valuable time for clinical intervention.

[0023] This invention provides an intelligent and programmed solution for safe tube removal and dislodgement, reducing operational risks. The invention integrates a unique intelligent dislodgement mode. Before removal, the system automatically performs a negative pressure test, intelligently determining tissue embedding by analyzing pressure decay dynamics. If embedding is confirmed, the system initiates controlled pulsed positive pressure airflow for dislodgement, instead of traditional liquid flushing or forceful tube removal. Pulsed positive pressure more effectively and mechanically separates adhered tissues, while setting pressure peaks and flow rates ensures safe and controllable force, avoiding the risks of tissue edema or infection spread that may result from liquid flushing. This mode transforms high-risk, experience-based operations into a standardized, safe, and controllable automated process.

[0024] This invention employs a magnetic connection structure to link the main unit and the tank, enabling rapid and accurate replacement of consumables. The gas-liquid isolation mechanism within the tank, combining a sealing piston with a pressure-stabilizing spring damper, effectively prevents liquid backflow from contaminating the main unit. The spring's cushioning effect also smooths out rapid pressure changes within the tank. Combined with the electronic closed-loop system, this further enhances pressure stability. The three-way connector assembly integrates a waterproof bacterial filter membrane, ensuring unobstructed pressure monitoring airflow while maintaining the cleanliness and safety of the main unit's internal airflow. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the overall assembly effect of the closed-loop feedback multifunctional negative pressure drainage management system of the present invention.

[0026] Figure 2 This is a schematic diagram of the host computer structure.

[0027] Figure 3 This is a schematic diagram of the internal structure of the host computer.

[0028] Figure 4 This is a schematic diagram of the connection of the host pressure generating unit.

[0029] Figure 5 A schematic diagram of the connection of the negative pressure generating unit for the main unit.

[0030] Figure 6 This is a schematic diagram of the control unit structure.

[0031] Figure 7 This is a schematic diagram of the tank assembly structure.

[0032] Figure 8 This is a schematic diagram of the tee connector assembly.

[0033] Figure 9 This is a cross-sectional schematic diagram of a tee connector assembly.

[0034] Figure 10 This is a schematic diagram of the drainage tube structure.

[0035] Figure 11 This is a schematic diagram of the cross-section of the drainage tube.

[0036] Figure 12 This is a side view of the drainage tube.

[0037] In the diagram: 1-Main unit, 1-1 Pressure monitoring port connecting pipe, 1-2 Infrared photoelectric sensor, 1-3 Liquid level sensor, 1-4 Infrared spectral sensor, 1-5 Display screen, 1-6 Main unit magnetic ring, 1-7 Pressure generating unit, 1-8 Negative pressure generating unit, 1-9 Pressure switching unit, 1-10 Control unit, 1-11 Pressure monitoring port tee connector, 1-12 Negative pressure suction port tee connector, 1-10-1 Pressure monitoring port pressure sensor, 1-10-2 Negative pressure suction port pressure sensor, 2-Tank assembly, 2-1 Tank shell, 2-2 O-ring, 2-3 Tank magnetic ring, 2-4 One-way valve, 2-5 Pressure sensing medium, 2-6 Sealing piston, 2-7 Pressure stabilizing spring shock absorber, 3-Tee connector assembly, 3-1 Flushing channel plug, 3-2 Waterproof bacterial filter membrane, 3-3 stainless steel flushing channel, 3-4 stainless steel pressure monitoring channel, 3-5 rotary valve, 4-drainage tube, 4-1 pressure monitoring channel, 4-2 flushing channel, 4-3 drainage side hole, 4-4 main drainage channel. Detailed Implementation

[0038] The present invention will be further explained and described below with reference to the accompanying drawings and embodiments.

[0039] This embodiment provides a closed-loop feedback multifunctional negative pressure drainage management system, such as... Figures 1 to 12 As shown, it mainly consists of a main unit 1, a tank assembly 2, a three-way connector assembly 3, and a drain pipe 4.

[0040] The main unit 1 and the tank assembly 2 are physically connected and fixed by a magnetic structure, specifically, the tank magnetic ring 2-3 inside the tank assembly 2 is magnetically attracted to the main unit magnetic ring 1-6 on the main unit 1. The outer shell 2-1 of the tank assembly 2 is made of rigid transparent plastic material and is sealed to the negative pressure air extraction port on the main unit 1 through an O-ring 2-2.

[0041] The tee fitting assembly 3 is threaded and pressurized to the tank assembly 2 to ensure no liquid leakage. The main unit 1 is equipped with a pressure monitoring port connection pipe 1-1, one end of which connects to the main unit's pressure monitoring port, and the other end connects to the end of the tee fitting assembly 3 equipped with a waterproof bacterial filter membrane 3-2. The waterproof bacterial filter membrane 3-2 effectively prevents the drainage fluid from entering the main unit 1. The drainage pipe 4 is connected to the tee fitting assembly 3 via a multi-channel structure, where the pressure monitoring channel 4-1 and the flushing channel 4-2 are respectively connected to the pressure monitoring channel stainless steel pipe 3-4 and the flushing channel stainless steel pipe 3-3 within the tee fitting assembly 3.

[0042] The main unit 1 integrates key control and power components, including a control unit 1-10, a pressure generating unit 1-7, a negative pressure generating unit 1-8, and a pressure switching unit 1-9. The main unit casing is equipped with a display screen 1-5, an infrared photoelectric sensor 1-2, a liquid level sensor 1-3, and an infrared spectral sensor 1-4. Each sensor is connected to the control unit 1-10 via a wiring harness.

[0043] like Figure 4 , Figure 5 As shown, the pressure generating unit 1-7 is connected to the pressure switching unit 1-9 through a connecting pipe. The pressure switching unit 1-9 is connected to one end of the air pressure monitoring port tee connector 1-11 through a connecting pipe. The other end of the air pressure monitoring port tee connector 1-11 is connected to the lower end of the air pressure monitoring port on the main unit 1 through a connecting pipe. The last end of the air pressure monitoring port tee connector 1-11 is connected to the air pressure monitoring port pressure sensor 1-10-1 on the control unit 1-10.

[0044] Pressure generating unit 1-7 provides bidirectional positive and negative pressure, and pressure switching unit 1-9 controls the airflow direction. Pressure sensor 1-10-1 at the air pressure monitoring port, connected to the air pressure monitoring port tee connector 1-11, the air pressure monitoring port, the air pressure monitoring port connecting pipe 1-1, the tee connector assembly 3, the air pressure monitoring channel stainless steel pipe 3-4, the air pressure monitoring channel 4-1, and the main drainage channel 4-4, can monitor the pressure value within the main drainage channel 4-4.

[0045] The negative pressure generating unit 1-8 has the function of providing negative pressure. One end of the negative pressure generating unit 1-8 is connected to one end of the negative pressure suction port tee connector 1-12 through a connecting pipe. The other end of the negative pressure suction port tee connector 1-12 is connected to the lower end of the negative pressure suction port on the main unit 1 through a connecting pipe. The last end of the negative pressure suction port tee connector 1-12 is connected to the negative pressure suction port pressure sensor 1-10-2 on the control unit 1-10.

[0046] like Figure 7As shown, a one-way valve 2-4 is installed on the outer shell of tank assembly 2 (2-1), which prevents backflow of the drainage fluid. A pressure-sensing medium 2-5 is attached to the inner cavity of the outer shell of tank assembly 2-1, displaying different colors depending on the external pressure. To prevent the drainage fluid from contaminating the main unit or causing abnormal pressure fluctuations, a gas-liquid isolation mechanism is provided inside tank assembly 2. This mechanism includes a piston fixing hole, a sealing piston 2-6, and a pressure-stabilizing spring damper 2-7, all located inside the outer shell. The sealing piston 2-6 is installed inside the outer shell piston fixing hole and can slide up and down within it, acting as a gas-liquid isolation device during drainage to prevent contamination of the main unit. Below the sealing piston 2-6 is the pressure-stabilizing spring damper 2-7, which prevents excessive pressure difference during drainage from causing the sealing piston 2-6 to be pressed directly to the bottom of the outer shell piston fixing hole, blocking the negative pressure extraction port of tank assembly 2.

[0047] like Figure 8 , 9 As shown, the tee connector assembly 3 is equipped with a stainless steel pipe 3-3 for flushing and a stainless steel pipe 3-4 for air pressure monitoring. One side of the connector is fitted with a 3-2 waterproof bacterial filter membrane, and the other side is fitted with a 3-1 flushing channel plug. The tee connector assembly 3 is also equipped with a 3-5 rotary valve, which can be used to open and close the connector's drainage channel.

[0048] like Figure 4 , Figure 5 , Figure 6 As shown, this invention employs a dual verification mechanism combining non-contact optical monitoring and a pneumatic sensor. Specifically, the first path uses non-contact monitoring, such as... Figure 7 As shown, a pressure-sensing medium 2-5 is attached to the inner cavity of the tank assembly 2. The pressure-sensing medium 2-5 has undergone extensive calibration tests beforehand, and its optical characteristic color wavelength corresponds one-to-one with the internal cavity pressure. Different colors are calibrated to corresponding pressure values. The infrared photoelectric sensor 1-2 on the main unit 1 is aligned with this color-changing membrane, identifying changes in its optical characteristics in real time and converting them into pressure electrical signals that are transmitted to the control unit 1-10. More specifically, when the system is working, the infrared photoelectric sensor 1-2 non-contactly identifies changes in the membrane color and converts them into pressure signals inside the tank, which are then transmitted to the control unit 1-10. The infrared spectral sensor 1-4 on the main unit 1 emits infrared light that passes through the light-transmitting area of ​​the tank assembly 2 and the internal drainage fluid. By analyzing the absorption rate of the drainage fluid to specific wavelengths of light, the control unit 1-10 can determine the composition of the drainage fluid, such as plasma, whole blood, exudate, or pus, in situ, and feed the results back to the display screen 1-5 in real time. If the system detects a sudden change in the characteristics of the drainage fluid, such as increased bleeding or worsening of purulent discharge, it will immediately issue an audible and visual alarm to assist doctors in making clinical judgments.

[0049] The second channel uses direct monitoring, such as Figure 4 As shown, the control unit 1-10 has an onboard pressure sensor 1-10-1 at the air pressure monitoring port. The pressure sensor 1-10-1, via a tee connector 1-11, monitoring tubing 1-1, tee connector assembly 3, stainless steel tubing 3-4, and drainage tube monitoring channel 4-1, can directly acquire the actual pressure values ​​at the end of the drainage tube and within the main drainage channel 4-4. The sensor can directly and in real-time monitor the actual pressure within the main drainage channel 4-4 at the end of the drainage tube, which is the pressure closest to the wound surface. The control unit 1-10 combines these two signals to adjust the output power of the negative pressure generating unit 1-8 in real-time, forming a closed-loop feedback to ensure that the drainage negative pressure remains constant within a preset standard value range.

[0050] The closed-loop control logic involves the control unit 1-10 synchronously receiving a direct pressure signal from the pressure sensor 1-10-1 at the air pressure monitoring port and an indirect verification signal from the infrared photoelectric sensor 1-2. The direct pressure signal reflects the real-time negative pressure at the wound site at the end of the drainage tube, serving as the main feedback reference for closed-loop control. The indirect verification signal reflects the pressure state inside the tank assembly 2, used to verify the system's airtightness and compensate for pressure fluctuations at the tank end. Specifically, the control unit 1-10 receives two signals. The first signal is used to verify the overall airtightness of the system and the state at the tank end, while the second signal serves as the target reference for control. By comparing the set negative pressure value with the real-time feedback pressure within the main drainage channel 4-4 at the end of the drainage tube, the control unit 1-10 drives the negative pressure generating unit 1-8 to dynamically adjust the suction power, thereby achieving fully closed-loop, adaptive, and stable control of the negative pressure at the wound site, effectively compensating for any pressure fluctuations caused by pipeline resistance, fluid inflow, etc. To facilitate understanding of the above technical solution of this invention, the following detailed description of its specific usage is provided.

[0051] The specific assembly and working process is as follows: Insert the tank assembly 2 into the negative pressure suction port of the main unit 1. The O-ring 2-2 plays a sealing role. The tank magnetic ring 2-3 inside the tank assembly 2 is magnetically attracted and fixed to the main unit magnetic ring 1-6 on the main unit 1. Connect the three-way connector assembly 3 to the tank assembly 2. The two are pressurized and sealed to ensure no liquid leakage. Connect the air pressure monitoring port connecting pipe 1-1 on the main unit 1 to the end of the three-way connector assembly 3 with the waterproof bacterial filter membrane 3-2 attached. Finally, connect the drainage tube 4 implanted in the patient's body to the three-way connector assembly 3 in sequence, ensuring that the air pressure monitoring channel 4-1 and flushing channel 4-2 of the drainage tube 4 are connected and assembled in sequence with the air pressure monitoring channel stainless steel pipe 3-4 and flushing channel stainless steel pipe 3-3 of the three-way connector assembly 3. Next, turn on the main unit 1 and set its working mode to drainage mode on display screens 1-5. Set the target standard negative pressure value for drainage and begin drainage. Before starting drainage, ensure that rotary valves 3-5 are open. The system will then begin working. At this time, the dual-path pressure feedback subsystem will activate to ensure that the wound pressure remains constant at the set value.

[0052] During the drainage process, the pressure sensor 1-10-1 at the air pressure monitoring port will monitor the pressure value of the main drainage channel 4-4 inside the drainage tube 4 in the patient's body in real time and issue a warning of blockage trend. If the pressure sensor 1-10-1 at the air pressure monitoring port detects that the pressure value is maintained at a negative pressure level higher than the initial value, it indicates that the drainage resistance has increased. If the spectral analysis does not show bleeding, the system will issue a blockage warning, indicating that there may be fibrin or tissue debris blockage, and recommend prophylactic flushing.

[0053] The infrared photoelectric sensor 1-2 on the main unit 1 identifies the color change of the pressure sensing medium 2-5 on the tank assembly in real time, outputs the corresponding pressure value, converts it into an electrical signal representing the internal pressure of the tank, and feeds it back to the control unit 1-10. The control unit 1-10 controls the negative pressure generated by the negative pressure generating unit 1-8 in real time based on the pressure values ​​of both sensors, ensuring the stability of the set standard negative pressure value for drainage. Simultaneously, an independent fluid property monitoring subsystem also operates synchronously: infrared light emitted by the infrared spectral sensor 1-4 penetrates the drainage fluid inside the tank assembly 2, and the control unit 1-10 analyzes its characteristic absorption spectrum to identify the components of the drainage fluid in real time. Based on this dual monitoring, the control unit 1-10 executes core closed-loop control. It first adjusts the output of the negative pressure generating unit 1-8 in real time based on the pressure signal fed back by the infrared photoelectric sensor 1-2 and the direct pressure signal from the pressure sensor 1-10-1 at the air pressure monitoring port, to maintain the stability of the set value of the wound drainage negative pressure. Meanwhile, if infrared spectral analysis detects abnormal spectral characteristics in the drainage fluid, such as those of whole blood, control unit 1-10 will immediately trigger a high-level bleeding audible and visual alarm to alert medical staff for emergency intervention.

[0054] Specifically, during the entire drainage process, infrared spectroscopy sensors 1-4 emit infrared light that penetrates the drainage fluid inside the transparent container. By analyzing the absorption rate of the drainage fluid to a specific wavelength of light, the system determines whether the drainage fluid is composed of plasma, whole blood, exudate, or pus. It then outputs the corresponding signal to the control unit 1-10. The control unit 1-10 recognizes the signal, displays the corresponding information on the display screen 1-5, and simultaneously issues an alarm to inform the doctor's decision on whether medication flushing is necessary.

[0055] Furthermore, during drainage, if the pressure in the main drainage channel 4-4, monitored by the pressure sensor 1-10-1, remains at a relatively high negative pressure for a considerable period (compared to the initial pressure at the start of drainage), and the infrared spectroscopy sensor 1-4 does not issue an alarm, the main unit 1 will issue an alarm signal, indicating to the doctor that the drainage fluid may be viscous, and that fibrin deposits or tissue debris may be blocking the drainage side hole 4-3. In this case, the doctor needs to dilute and flush the drainage tube with saline solution.

[0056] When the doctor performs medication flushing or saline flushing, the flushing channel plug 3-1 needs to be unscrewed. A sterile syringe is then connected to the flushing port of the three-way connector assembly 3 to inject the medication or saline solution into the drainage tube flushing channel 4-2. The medication or saline solution will enter the patient's body through the flushing channel 4-2, then pass through the drainage side hole 4-3 into the main drainage channel 4-4, and finally be drained into the tank assembly 2.

[0057] When the level of the drainage fluid in tank assembly 2 reaches the range detected by level sensors 1-3 on host 1, host 1 will stop working and issue an alarm to prompt medical staff to replace tank assembly 2.

[0058] When drainage is complete and the tube needs to be removed, set the main unit 1 to the removal mode on display screens 1-5 and select the specifications of the drainage tube used by the patient. The control system of main unit 1 will calculate the optimal airflow volume required based on the corresponding drainage tube specifications to ensure that the total amount of gas blown into the body is controlled. Before operating in removal mode, first close rotary valves 3-5 to ensure that the connector drainage channel is in the closed state.

[0059] In disengagement mode, the system generates a positive pressure with a set maximum peak value to prevent the risk of emphysema or air embolism. The positive pressure generated by pressure generating units 1-7 enters the main drainage channel 4-4 through the connected tubing system. The positive pressure release is set to a second-level pulse to prevent continuous gas from entering the body cavity and causing tissue damage to the patient.

[0060] Before applying positive pressure, the system performs a weak negative pressure test via pressure generation unit 1-7 and pressure switching unit 1-9. If the negative pressure detected by pressure sensor 1-10-1 at the pressure monitoring port is large compared to the standard negative pressure value given by the negative pressure test, or if the negative pressure decreases too slowly, then the tissue is confirmed to be impinged. Conversely, if the negative pressure detected by pressure sensor 1-10-1 at the pressure monitoring port drops sharply during the negative pressure test, it indicates that the tissue is not impinged and the tube can be removed directly.

[0061] First, close the rotary valve 3-5 of the tee connector assembly 3 to ensure that the drainage channel of the tee connector assembly is in the closed state. On the display screen 1-5, set the main unit 1 to the unembedded mode, select the corresponding drainage tube model and specification, and the main unit 1 will start running.

[0062] First, the host 1 performs a negative pressure test. The host will give a prompt to directly disconnect the tube or to perform positive pressure disconnection based on the change in negative pressure data detected by the pressure sensor at the 1-10-1 air pressure monitoring port.

[0063] If the next step of positive pressure decoupling is required, the pressure generating unit 1-7 and the pressure switching unit 1-9 will first be set to release second-level pulse positive pressure. The gas will pass through the pipeline and enter the end of the three-way connector assembly 3 equipped with the waterproof bacterial filter membrane 3-2. The airflow will become sterile airflow and enter the drainage tube air pressure monitoring channel, and then enter the main drainage channel.

[0064] Pressure generating unit 1-7 begins to output a small amount of positive pressure airflow with a constant flow rate. Pressure sensor 1-10-1 at the air pressure monitoring port monitors the instantaneous pressure in the drainage tube in real time. At the peak, if the pressure reaches the preset disengagement pressure peak within a short period of time, it indicates that the tissue is currently in a tightly embedded state.

[0065] During a sudden change, continuous pulse pressure is applied. When the pressure sensor detects a sharp drop in pressure, it means that the airflow has broken through the tissue and the drainage side hole has been restored to unobstructed flow.

[0066] When the pressure stabilizes at the intracavitary pressure level, which is close to atmospheric pressure or slightly positive pressure, the system determines that the tissue has completely detached.

[0067] When the result feedback is successful, the main unit will emit a flashing green signal or beep, indicating that the tissue has been detached and the tube can be safely removed. If the result feedback fails or a retry is required, and the pressure remains high without decreasing, it indicates that severe embedment still exists. The system will automatically adjust the pulse frequency to attempt a second unembedding, or manual intervention may be required.

[0068] This invention achieves multi-functional collaboration and performance optimization through high-level system integration. It is not a simple aggregation of functions, but rather a deep integration of subsystems such as closed-loop pressure control, optical component analysis, and intelligent de-embedding. For example, pressure monitoring data is used for both pressure stabilization and blockage trend analysis; spectral analysis results can be linked with abnormal pressure signals to help determine the nature of the blockage, such as blood clots or viscous pus. This multi-modal information fusion and collaborative decision-making makes the overall system performance greater than the sum of its individual functions, achieving a leap from a single-function device to an intelligent clinical auxiliary management system.

[0069] In the description of this invention, it should be noted that the terms "upper," "lower," etc., indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the invention and 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, and therefore should not be construed as a limitation of the invention. Unless otherwise expressly specified and limited, the terms "installed," "connected," and "linked" 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; they can refer to the internal communication between two elements. For those skilled in the art, the specific meaning of the above terms in this invention can be understood according to the specific circumstances.

[0070] It should be noted that in this invention, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0071] The above description is merely a specific embodiment of the present invention, enabling those skilled in the art to understand or implement the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features of the invention described herein.

Claims

1. A closed-loop feedback multifunctional negative pressure drainage management system, comprising: The main unit (1) integrates a control unit (1-10), a negative pressure generating unit (1-8), and a sensor assembly. The tank assembly (2) is a rigid, fixed-volume cavity used to collect drainage fluid and is detachably connected to the main unit (1). A drainage tube (4) is used to be implanted in the patient's body at one end, and the other end is connected to the canister assembly (2) through a pipeline fluid path. The system is characterized by having a closed-loop pressure feedback mechanism. The host (1) adjusts the output power of the negative pressure generating unit (1-8) in real time according to the monitored pressure data. The closed-loop pressure feedback mechanism includes a non-contact optical monitoring subsystem, which includes a pressure sensing medium (2-5) installed on the tank assembly (2). The pressure sensing medium (2-5) changes its optical properties according to the pressure it receives. The host (1) is equipped with a photoelectric detection device (1-2). When the tank assembly (2) is connected to the host (1), the photoelectric detection device (1-2) is aligned with the pressure sensing medium (2-5), identifies its optical property changes in real time, and converts them into pressure signals that are transmitted to the control unit (1-10). The host (1) also integrates a pressure generating unit (1-7) and a pressure switching unit (1-9); the control unit (1-10) is configured to have a disengagement mode, in which the control unit (1-10) controls the pressure switching unit (1-9) and the pressure generating unit (1-7) to output pulsed positive pressure airflow into the drainage tube (4) to release the tissue impingement in the side hole of the drainage tube; When the control unit (1-10) executes the de-embedding mode, it performs the following control logic: before outputting positive pressure airflow, it controls the negative pressure generating unit (1-8) to perform a negative pressure test; it determines whether there is embedding by monitoring the negative pressure decay rate in the drainage tube; if it is determined to be embedding, it outputs a pulsed positive pressure airflow with a set peak value and monitors the pressure change signal in real time to determine whether the tissue has detached. The closed-loop pressure feedback mechanism also includes a pressure sensor (1-10-1) installed inside the host (1); the pressure sensor (1-10-1) is connected to the pressure monitoring channel (4-1) inside the drainage tube (4) through the pressure monitoring pipeline, and directly monitors the real pressure at the end of the drainage tube; the control unit (1-10) combines the pressure signal from the photoelectric detection device (1-2) and the pressure signal from the pressure sensor (1-10-1) to perform dual verification and adjustment of the drainage negative pressure.

2. The closed-loop feedback multifunctional negative pressure drainage management system according to claim 1, characterized in that, The management system further includes a real-time fluid property monitoring subsystem. At least a portion of the tank assembly (2) is made of a light-transmitting material. An infrared spectral sensor (1-4) is provided on the host (1). The infrared spectral sensor (1-4) is located outside the light-transmitting area of ​​the tank assembly (2). The infrared spectral sensor (1-4) is used to emit infrared light into the drainage fluid in the tank assembly (2) and receive transmitted or reflected light. By analyzing the absorption rate of the drainage fluid to light of a specific wavelength, the composition of the drainage fluid is identified. The composition includes at least one or more of plasma, whole blood, exudate, and pus.

3. The closed-loop feedback multifunctional negative pressure drainage management system according to claim 1, characterized in that, The tank assembly (2) is provided with a gas-liquid isolation mechanism inside; the gas-liquid isolation mechanism includes a piston fixing hole, a sealing piston (2-6) and a pressure stabilizing spring damper (2-7) provided in the outer shell of the tank; the sealing piston (2-6) is slidably installed in the piston fixing hole, and the pressure stabilizing spring damper (2-7) abuts against the bottom of the sealing piston (2-6) to buffer pressure fluctuations and prevent the sealing piston (2-6) from blocking the negative pressure exhaust port.

4. The closed-loop feedback multifunctional negative pressure drainage management system according to claim 1, characterized in that, The pressure sensing medium (2-5) is a pressure-sensitive color-changing film, which is attached to the inner wall of the tank assembly (2); the photoelectric detection device (1-2) is an infrared photoelectric sensor, used to identify the color change of the pressure-sensitive color-changing film.

5. The closed-loop feedback multifunctional negative pressure drainage management system according to claim 1, characterized in that, It also includes a three-way connector assembly (3), which is connected between the tank assembly (2) and the drain pipe (4); the three-way connector assembly (3) is equipped with a waterproof bacterial filter membrane (3-2) for connecting to the air pressure monitoring interface of the host (1) to prevent liquid from entering the host.

6. The closed-loop feedback multifunctional negative pressure drainage management system according to claim 1, characterized in that, The host (1) and the tank assembly (2) are physically connected and fixed by a magnetic attraction structure; the magnetic attraction structure includes a host magnetic ring (1-6) set on the host and a tank magnetic ring (2-3) set on the tank assembly.

7. The closed-loop feedback multifunctional negative pressure drainage management system according to any one of claims 1-6, characterized in that, The intelligent dislodgement control method of the system includes the following steps: real-time monitoring of the pressure and flow status in the drainage tube; when an abnormal increase in pressure is detected and the duration exceeds a preset threshold, and spectral analysis does not indicate a risk of bleeding, a flushing alarm is issued; when a tube removal command is received, the system enters the dislodgement mode and determines whether tissue entrapment has occurred in the drainage hole through a pre-prepared micro-negative pressure test; if entrapment is determined, a controlled pulsed positive pressure airflow is automatically generated and blown into the drainage tube until a sharp drop in pressure is detected, confirming that the tissue has detached.

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