Hydrops drainage and extraction equipment and use method thereof

Abstract

The invention relates to effusion drainage and extraction equipment and a use method thereof, and belongs to the technical field of medical equipment.The effusion drainage and extraction equipment comprises a multi-mode sensor module, a negative pressure control unit, a central processing module, a man-machine interaction module, an equipment shell, an effusion collection bottle, a communicating pipe, a disposable drainage pipe and a puncture needle; the multi-mode sensor module comprises a miniature pressure sensor array, a miniature flow sensor and a capacitive liquid level sensor. According to the invention, through combined monitoring of the micro pressure sensor array, the micro flow sensor and the capacitive liquid level sensor, intracavity pressure, hydrops flow velocity and hydrops amount data are obtained in real time, subjective judgment deviation of traditional manual operation is eliminated, and it is ensured that the pressure change rate conforms to safety constraints; and when the abnormal pressure is suddenly reduced or the single drainage amount exceeds the limit, suction is stopped immediately, and pressure compensation is started, so that risk early warning is realized, and the safety is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a fluid drainage and extraction device and a method for using the same. Background Art

[0002] The cardiology department, namely the cardiovascular medicine department, is a clinical department set up in the general internal medicine department of hospitals at all levels for the diagnosis and treatment of cardiovascular diseases. The diseases treated include angina pectoris, hypertension, sudden death, arrhythmia, heart failure, premature beats, arrhythmia, myocardial infarction, cardiomyopathy, myocarditis, acute myocardial infarction and other cardiovascular diseases. In the treatment of cardiovascular diseases, a drainage device is an essential treatment device, which plays an important role in draining the body fluids accumulated under the skin or in the cavity of the patient out of the body.

[0003] During the process of thoracentesis or pericardiocentesis for pleural effusion or pericardial effusion drainage, a thoracentesis needle or a pigtail catheter needs to be used. After slowly inserting the needle, the fluid is aspirated or the catheter is placed for drainage, and the drainage speed is controlled during drainage. The pleural effusion usually does not exceed 1500 ml per day to avoid reexpansion pulmonary edema, and the pericardial effusion drainage does not exceed 200 mL to avoid hemodynamic fluctuations caused by limited ventricular diastolic expansion.

[0004] Traditional fluid drainage devices usually rely on manual adjustment of negative pressure. Such drainage devices require medical staff to adjust the aspiration pressure according to subjective judgment, with strong experience dependence. Improper operation is likely to cause acute cardiac dilation or reexpansion pulmonary edema. Due to the lack of real-time monitoring, it is impossible to dynamically sense the changes in the fluid volume, flow rate, and pressure in the cavity, resulting in difficulty in balancing the drainage efficiency and safety. Moreover, the manual adjustment method has the risk of hysteresis, slow response speed, and inability to respond promptly to sudden pressure changes. Therefore, a fluid drainage and extraction device and a method for using the same are proposed herein. Multimodal sensors are used to detect the pressure in the cavity, the flow rate of the drained fluid, and the fluid volume in real time, eliminating the subjective judgment deviation of traditional manual operations, ensuring that the pressure change rate meets the safety constraints. When an abnormal pressure drop or an excessive single drainage volume is detected, the aspiration is immediately stopped and pressure compensation is started, thereby realizing risk warning and improving safety. Summary of the Invention

[0005] The present invention provides a fluid drainage and extraction device and a method for using the same, which solve the problems raised in the above background art. By restricting the single drainage volume and the pressure change rate, complications such as reexpansion pulmonary edema and cardiac tamponade are avoided at the root. Compared with traditional drainage devices, such a fluid drainage and extraction method can effectively avoid adverse events caused by over-drainage, realizing the precision and safety of fluid drainage, and solving the pain points of traditional devices that rely on experience, have a lag in response, and a high risk of complications.

[0006] The solution of the present invention to the above technical problems is as follows: A fluid drainage extraction device includes a multi-modal sensor module, a negative pressure control unit, a central processing module, a human-machine interaction module, a device housing, a fluid collection bottle, a connecting pipe, a disposable drainage tube, and a puncture needle. The multi-modal sensor module includes a micro pressure sensor array, a micro flow sensor, and a capacitive liquid level sensor;

[0007] The negative pressure control unit includes a brushless DC micro vacuum pump and a pressure buffer bottle;

[0008] The central processing module uses an ARM Cortex-M7 processor;

[0009] The human-machine interaction module includes a medical touch screen;

[0010] The brushless DC micro vacuum pump and the medical touch screen are installed inside the device housing. The device housing is equipped with a device power supply, which supplies power to the brushless DC micro vacuum pump and the medical touch screen. The brushless DC micro vacuum pump is connected to a PID regulating valve through a pipe and is connected to the pressure buffer bottle through the PID regulating valve. The pressure buffer bottle and the fluid collection bottle are connected through a connecting pipe. The capacitive liquid level sensor is installed and inserted into the fluid collection bottle. The fluid collection bottle is threadedly connected to the micro flow sensor. The micro flow sensor is threadedly connected to the disposable drainage tube. The disposable drainage tube is connected to the puncture needle. The micro pressure sensor array is installed at one end of the needle tip of the puncture needle. The micro pressure sensor array is connected to a signal transmitter through a wire. The signal transmitter is clamped to the tail end of the puncture needle through a clamp. The puncture needle is provided with an annular groove corresponding to the micro pressure sensor array, and the puncture needle is provided with a spiral wire groove;

[0011] The usage method includes the following steps:

[0012] S1: Preoperative preparation: Check the device. Each component has no physical damage, and the power of each power supply module is greater than or equal to 80%. Ensure that the drainage tube and the puncture needle have completed low-temperature plasma sterilization treatment. Connect the fluid collection bottle and the pressure buffer bottle through the connecting pipe. Threadedly connect the capacitive liquid level sensor to the fluid collection bottle, and insert the detection end into the fluid collection cavity. Connect the micro flow sensor to the fluid collection bottle, then connect the disposable drainage tube to the micro flow sensor, and connect the puncture needle to the disposable drainage tube to complete the preparation work of the device;

[0013] S2: Patient assessment and mode selection: Determine the type of fluid accumulation (pericardial / pleural) and estimate the fluid volume based on imaging examinations (such as ultrasound, CT). Select the corresponding mode on the medical touch screen and adjust according to the actual situation of the patient: Pericardial mode: The default maximum daily drainage volume is 200 mL, and the pressure drop rate ≤ 5 mmHg / min. Pleural mode: The default maximum daily drainage volume is 1.5 L, and the pressure drop rate ≤ 10 mmHg / min;

[0014] S3: Equipment initialization: Place the puncture needle in a saline environment, perform zero calibration of the micro flow sensor and baseline calibration of the capacitive liquid level sensor. Start the brushless DC micro vacuum pump to preheat for five seconds, initialize the PID regulating valve, and pre-charge the pressure buffer bottle to the ambient pressure;

[0015] S4: Drainage operation: Under ultrasound guidance, insert the puncture needle into the fluid accumulation cavity of the pericardium or pleura, ensure that the micro pressure sensor array is located in the fluid accumulation area, and observe the pressure waveform feedback by the signal transmitter in real time through the medical touch screen. Confirm that the sensor signal is stable, and the signal fluctuation < ±1 mmHg. Start the adaptive drainage, and start the drainage operation at the medical touch screen. The central processing module performs the following operations:

[0016] 1. Initial negative pressure setting: Automatically load the preset value according to the type of fluid accumulation (pericardium: 50 - 80 mmHg; pleura: 20 - 50 mmHg);

[0017] 2. Dynamic adjustment: The LSTM algorithm analyzes the time series data of pressure (P), flow rate (F), and fluid volume (V) in real time, predicts the optimal negative pressure value (P_target), and the brushless DC micro vacuum pump and the PID regulating valve are linked to maintain the pressure in the pressure buffer bottle within the range of P_target ± 2 mmHg;

[0018] S5: Risk monitoring and intervention: If the vacuum pump speed drops to 50%, and there is a sudden pressure drop (ΔP > 10 mmHg / 10 s), the system immediately pauses suction and starts pressure compensation, injects 5 mL of sterile air buffer, and automatically terminates when the preset safe drainage volume is reached, and manual intervention is performed. Medical staff can manually override the automatic mode, temporarily adjust the negative pressure or terminate the drainage;

[0019] S6: Drainage termination and data archiving: The system automatically terminates when the preset safe drainage volume is reached or the intracavitary pressure returns to the physiological baseline: pericardium: 5 - 15 mmHg (normal pericardial pressure), pleura: -5 to +5 mmHg (normal pleural pressure). Manually terminate the operation, turn off the brushless DC micro vacuum pump, release the residual negative pressure of the PID regulating valve, and the central processing module generates a drainage report, including the pressure-time curve and the cumulative drainage volume;

[0020] S7: Post-operative treatment: Clean and maintain the device, clean and perform performance testing on reusable components, monitor the patient, closely observe vital signs such as heart rate and blood oxygen saturation within 4 hours after the operation, and check for signs of re-expansion pulmonary edema or cardiac tamponade.

[0021] Based on the above technical solutions, the present invention can be further improved as follows.

[0022] Further, in S2, the mode switch is restricted, and the pericardial and thoracic modes cannot be used interchangeably. The system needs to be completely reset and recalibrated before switching.

[0023] Further, both the signal transmitter and the capacitive liquid level sensor are provided with built-in power supply modules and signal transmission modules. The built-in power supply module of the signal transmitter supplies power to the micro pressure sensor array through a wire, and the pressure detection signal and liquid signal can be transmitted to the central processing module through the signal transmission module.

[0024] Further, a partition board is installed in the effusion collection bottle. There are two partition boards, and the two partition boards divide the effusion collection bottle into an effusion collection chamber, a buffer chamber, and an air extraction chamber. A one-way valve is installed on one side of the partition board. The effusion collection bottle is divided by the partition board. The effusion collection chamber can be used to collect and measure the drained effusion, and the buffer chamber can buffer and protect the air extraction chamber, thereby preventing the effusion from reaching the connecting pipe.

[0025] Further, the detection end of the capacitive liquid level sensor is inserted into the effusion collection chamber, the connecting pipe is connected to the air extraction chamber, and the effusion collection bottle is provided with a scale corresponding to the effusion collection chamber. The collected liquid level can be manually observed through the scale, and the effusion in the effusion collection chamber can be detected in real time through the capacitive liquid level sensor.

[0026] Further, the position where the annular groove is opened is 0.5 - 1.5 cm away from the pipe orifice. There are six micro pressure sensor arrays, which are evenly arranged. The micro pressure sensor arrays are installed in the annular groove through medical epoxy resin glue to ensure that the pressure detection of the micro pressure sensor arrays covers the circumferential area and eliminates local pressure measurement deviation.

[0027] Further, the micro pressure sensor arrays are connected to the signal transmitter through wires. Both the annular groove and the spiral wire groove are covered with a medical-grade silicone layer by micro-injection molding technology, and the wire spirals along the puncture needle to reduce stress concentration during bending.

[0028] Further, the medical-grade silicone layer of the annular groove is provided with micro pressure balance holes corresponding to the detection ends of the micro pressure sensor arrays, and the detection ends of the micro pressure sensor arrays pass through the micro pressure balance holes, ensuring that the detection ends of the micro pressure sensor arrays are in direct contact with the body fluid in the lumen of the tube, while avoiding tissue damage caused by the protrusion of the sensor.

[0029] The beneficial effects of the present invention are as follows: The present invention provides a fluid drainage extraction device and its usage method, having the following advantages:

[0030] 1. Through the combined monitoring of the micro pressure sensor array, micro flow sensor, and capacitive liquid level sensor, real-time data on the intracavity pressure, fluid drainage rate, and fluid volume are obtained, eliminating the subjective judgment deviation of traditional manual operations, ensuring that the pressure change rate meets safety constraints. When an abnormal pressure drop or a single drainage volume limit is detected, suction is immediately stopped and pressure compensation is initiated, thereby realizing risk warning and improving safety.

[0031] 2. It supports dual-mode switching for pericardial effusion and pleural effusion, and can be adjusted according to the actual situation of the patient to meet different clinical needs. The touch screen displays the pressure-time curve, cumulative drainage volume, and operation guidelines in real-time, reducing the operation complexity.

[0032] 3. An emergency braking mechanism is set: when an abnormal pressure drop or a single drainage volume limit is detected, suction is immediately stopped and pressure compensation is initiated.

[0033] 4. By restricting the single drainage volume and pressure change rate, complications such as reexpansion pulmonary edema and cardiac tamponade are avoided at the source. Compared with traditional drainage devices, such a fluid drainage extraction method can effectively avoid adverse events caused by over-drainage, realizing the precision and safety of fluid drainage, and solving the pain points of traditional devices relying on experience, having a lag in response, and a high risk of complications.

[0034] The above description is only an overview of the technical solution of the present invention. In order to be able to understand the technical means of the present invention more clearly and to be implemented in accordance with the content of the specification, the following takes the preferred embodiments of the present invention and combines with the accompanying drawings to describe in detail as follows. The specific implementation manner of the present invention is given in detail by the following embodiments and their accompanying drawings. Description of the Drawings

[0035] The accompanying drawings described herein are used to provide a further understanding of the present invention, and constitute a part of this application. The schematic embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation to the present invention. In the drawings:

[0036] Figure 1 It is a schematic structural diagram of a fluid drainage extraction device and its usage method provided by an embodiment of the present invention;

[0037] Figure 2 It is a front view of a fluid drainage extraction device and its usage method provided by an embodiment of the present invention;

[0038] Figure 3Schematic diagram of the structure of a puncture needle in a fluid drainage and extraction device and its usage method provided by an embodiment of the present invention;

[0039] Figure 4 Schematic diagram of the structure of an annular groove in a fluid drainage and extraction device and its usage method provided by an embodiment of the present invention;

[0040] Figure 5 Schematic diagram of the structure of a spiral wire groove in a fluid drainage and extraction device and its usage method provided by an embodiment of the present invention.

[0041] In the drawings, the list of components represented by each reference numeral is as follows:

[0042] 1. Micro pressure sensor array; 2. Micro flow sensor; 3. Capacitive liquid level sensor; 4. Brushless DC micro vacuum pump; 5. Pressure buffer bottle; 6. Medical touch screen; 7. Device housing; 8. Device power supply; 9. PID regulating valve; 10. Fluid collection bottle; 11. Connecting pipe; 12. Disposable drainage tube; 13. Puncture needle; 14. Signal transmitter; 15. Partition board; 16. Fluid collection cavity; 17. Buffer cavity; 18. Air extraction cavity; 19. Check valve; 20. Scale; 21. Annular groove; 22. Spiral wire groove; 23. Medical grade silicone layer. Detailed implementation manners

[0043] The following combines the attached Figures 1-5 The principles and features of the present invention are described below. The examples given are only used to explain the present invention and are not intended to limit the scope of the present invention. In the following paragraphs, the present invention is described more specifically by way of example with reference to the accompanying drawings. The advantages and features of the present invention will be clearer according to the following description and the claims. It should be noted that the drawings are all in a very simplified form and use non-precise scales, only for the purpose of facilitating and clearly assisting in explaining the purpose of the embodiments of the present invention.

[0044] It should be noted that when a component is referred to as being "fixed to" another component, it can be directly on the other component or there can also be an intermediate component. When a component is considered to be "connected to" another component, it can be directly connected to the other component or there may be an intermediate component at the same time. When a component is considered to be "arranged on" another component, it can be directly arranged on the other component or there may be an intermediate component at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are only for the purpose of illustration.

[0045] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field to which this invention belongs. The terms used in the description of the present invention herein are for the purpose of describing specific embodiments only and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0046] As Figures 1-5 shown, the present invention provides a fluid drainage extraction device, including a multimodal sensor module, a negative pressure control unit, a central processing module, a human-computer interaction module, a device housing 7, a fluid collection bottle 10, a connecting pipe 11, a disposable drainage tube 12, and a puncture needle 13. The multimodal sensor module includes a micro pressure sensor array 1, a micro flow sensor 2, and a capacitive liquid level sensor 3;

[0047] The negative pressure control unit includes a brushless DC micro vacuum pump 4 and a pressure buffer bottle 5;

[0048] The central processing module uses an ARM Cortex-M7 processor;

[0049] The human-computer interaction module includes a medical touch screen 6;

[0050] The brushless DC micro vacuum pump 4 and the medical touch screen 6 are installed inside the device housing 7. The device housing 7 is equipped with a device power supply 8, and the device power supply 8 supplies power to the brushless DC micro vacuum pump 4 and the medical touch screen 6. The brushless DC micro vacuum pump 4 is connected to a PID regulating valve 9 through a pipeline and is connected to the pressure buffer bottle 5 through the PID regulating valve 9. The pressure buffer bottle 5 and the fluid collection bottle 10 are connected through the connecting pipe 11. The capacitive liquid level sensor 3 is installed and inserted into the fluid collection bottle 10. The fluid collection bottle 10 is threadedly connected to the micro flow sensor 2. The micro flow sensor 2 is threadedly connected to the disposable drainage tube 12. The disposable drainage tube 12 is connected to the puncture needle 13. The micro pressure sensor array 1 is installed at the needle end of the puncture needle 13. The micro pressure sensor array 1 is connected to a signal transmitter 14 through a wire. The signal transmitter 14 is clamped to the tail end of the puncture needle 13 through a block. The puncture needle 13 is provided with an annular groove 21 corresponding to the micro pressure sensor array 1, and the puncture needle 13 is provided with a spiral wire groove 22.

[0051] Preferably, in S2, the mode switching is restricted, and the pericardial and thoracic modes cannot be mixed. The system needs to be completely reset and recalibrated before switching.

[0052] Preferably, both the signal transmitter 14 and the capacitive liquid level sensor 3 are provided with an internal power supply module and a signal transmitting module. The internal power supply module of the signal transmitter 14 supplies power to the micro pressure sensor array 1 through a wire, and the pressure detection signal and the liquid signal can be transmitted to the central processing module through the signal transmitting module.

[0053] Preferably, a partition plate 15 is installed in the liquid accumulation collection bottle 10. There are two partition plates 15. The two partition plates 15 divide the liquid accumulation collection bottle 10 into a liquid accumulation collection chamber 16, a buffer chamber 17, and an air extraction chamber 18. A one-way valve 19 is installed on one side partition plate 15. The liquid accumulation collection bottle 10 is divided by the partition plate. The liquid accumulation collection chamber 16 can be used to collect and measure the drained liquid, and the buffer chamber 17 can buffer and protect the air extraction chamber 18, thereby preventing the liquid from reaching the communication pipe 11.

[0054] Preferably, the detection end of the capacitive liquid level sensor 3 is inserted into the liquid accumulation collection chamber 16, the communication pipe 11 communicates with the air extraction chamber 18, and the liquid accumulation collection bottle 10 is provided with a scale 20 corresponding to the liquid accumulation collection chamber 16. The collected liquid level can be visually observed through the scale 20, and the liquid in the liquid accumulation collection chamber 16 can be detected in real time through the capacitive liquid level sensor 3.

[0055] Preferably, the position where the annular groove 21 is opened is 0.5 - 1.5 cm away from the pipe orifice. There are six micro pressure sensor arrays 1, which are arranged evenly. The micro pressure sensor array 1 is installed in the annular groove 21 through medical epoxy resin glue to ensure that the pressure detection of the micro pressure sensor array 1 covers the circumferential area and eliminates local pressure measurement deviation.

[0056] Preferably, the micro pressure sensor array 1 is connected to the signal transmitter 14 through a wire. Both the annular groove 21 and the spiral wire groove 22 are covered with a medical grade silicone layer 23 by micro injection molding technology and are spirally routed along the puncture needle 13 to reduce stress concentration during bending.

[0057] Preferably, the medical grade silicone layer 23 of the annular groove 21 is provided with micro pressure balance holes corresponding to the detection ends of the micro pressure sensor array 1. The detection ends of the micro pressure sensor array 1 pass through the micro pressure balance holes to ensure that the detection ends of the micro pressure sensor array 1 are in direct contact with the body fluid in the lumen, while avoiding tissue damage caused by sensor protrusions.

[0058] The specific working principle and usage method of the present invention are as follows:

[0059] S1: Preoperative preparation: Check the equipment to ensure that each component has no physical damage and the power of each power supply module is greater than ≥80%. Ensure that the drainage tube and puncture needle have completed low-temperature plasma sterilization. Connect the liquid collection bottle 10 and the pressure buffer bottle 5 through the connecting tube 11. Thread the capacitive liquid level sensor 3 onto the liquid collection bottle 10 and insert the detection end into the liquid collection cavity 16. Connect the micro flow sensor 2 to the liquid collection bottle 10 and then connect the disposable drainage tube 12 to the micro flow sensor 2. Connect the puncture needle 13 to the disposable drainage tube 12 to complete the equipment preparation work;

[0060] S2: Patient evaluation and mode selection: Determine the type of effusion (pericardial / pleural) and the estimated effusion volume based on imaging examinations such as ultrasound and CT. Select the corresponding mode on the medical touch screen 6: Pericardial mode: The default maximum daily drainage volume is 200 mL, and the pressure drop rate ≤5 mmHg / min. Pleural mode: The default maximum daily drainage volume is 1.5 L, and the pressure drop rate ≤10 mmHg / min. Limit the mode switch. The pericardial and pleural modes cannot be used interchangeably. The system needs to be completely reset and recalibrated before switching;

[0061] S3: Equipment initialization: Place the puncture needle 13 in a saline environment, perform zero calibration of the micro flow sensor 2 and baseline calibration of the capacitive liquid level sensor 3. Start the brushless DC micro vacuum pump 4 to preheat for five seconds, initialize the PID regulating valve 9, and pre-charge the pressure buffer bottle 5 to the ambient pressure;

[0062] S4: Drainage operation: Under ultrasonic guidance, insert the puncture needle 13 into the effusion cavity of the pericardium or pleura, ensure that the micro pressure sensor array 1 is located in the effusion area, and observe the pressure waveform fed back by the signal transmitter 14 in real time through the medical touch screen 6. Confirm that the sensor signal is stable and the signal fluctuation <±1 mmHg. Start adaptive drainage and start the drainage operation at the medical touch screen 6. The central processing module performs the following operations:

[0063] 1. Initial negative pressure setting: Automatically load the preset value according to the type of effusion. Pericardium: 50 - 80 mmHg; Pleura: 20 - 50 mmHg;

[0064] 2. Dynamic adjustment: The LSTM algorithm analyzes the time series data of pressure P, flow rate F, and effusion volume V in real time, predicts the optimal negative pressure value P_target, and the brushless DC micro vacuum pump 4 and the PID regulating valve 9 are linked to maintain the pressure of the pressure buffer bottle 5 within the range of P_target±2 mmHg;

[0065] S5: Risk Monitoring and Intervention: When the vacuum pump speed drops to 50% and there is a sudden pressure drop of ΔP > 10 mmHg / 10 s, the system immediately suspends suction and activates pressure compensation, injects 5 mL of sterile air for buffering. When the preset safe drainage volume is reached, the system automatically terminates, and manual intervention is carried out. Medical staff can manually override the automatic mode, temporarily adjust the negative pressure or terminate the drainage;

[0066] S6: Drainage Termination and Data Archiving: The system automatically terminates when the preset safe drainage volume is reached or the intracavity pressure returns to the physiological baseline: Pericardium: 5 - 15 mmHg for normal pericardial pressure, Thorax: -5 to +5 mmHg for normal pleural pressure. Manual termination operation is performed, the brushless DC micro vacuum pump 4 is turned off, the PID regulating valve 9 releases the residual negative pressure, and the central processing module generates a drainage report, including the pressure-time curve and the cumulative drainage volume;

[0067] S7: Postoperative Treatment: Clean and maintain the equipment, clean and perform performance testing on reusable components, monitor the patient, and closely observe vital signs such as heart rate and blood oxygen saturation within 4 hours after surgery to check for signs of reexpansion pulmonary edema or cardiac tamponade.

[0068] It should be noted that in this article, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. The content not described in detail in this specification belongs to the prior art well-known to those skilled in the art.

[0069] The above is only a preferred embodiment of the present invention, and does not impose any form of limitation on the present invention; any ordinary technician in the industry can smoothly implement the present invention as shown in the accompanying drawings of the specification and described above; however, any equivalent changes made by those skilled in the art within the scope of the technical solution of the present invention by using the technical content disclosed above, such as minor modifications, decorations, and evolutions, are equivalent embodiments of the present invention; at the same time, any equivalent changes, modifications, and evolutions made to the above embodiments based on the essential technology of the present invention still fall within the protection scope of the technical solution of the present invention.

Claims

1. A fluid drainage and extraction device, comprising a multimodal sensor module, a negative pressure control unit, a central processing module, a human-computer interaction module, a device housing (7), a fluid collection bottle (10), a connecting pipe (11), a disposable drainage tube (12), and a puncture needle (13), characterized in that: The multimodal sensor module includes a micro pressure sensor array (1), a micro flow sensor (2), and a capacitive liquid level sensor (3); The negative pressure control unit includes a brushless DC micro vacuum pump (4) and a pressure buffer bottle (5); The central processing module uses an ARM Cortex-M7 processor; The human-computer interaction module includes a medical touch screen (6); The brushless DC micro vacuum pump (4) and the medical touch screen (6) are installed in the device housing (7). The device housing (7) is equipped with a device power supply (8). The device power supply (8) supplies power to the brushless DC micro vacuum pump (4) and the medical touch screen (6). The brushless DC micro vacuum pump (4) is connected to a PID regulating valve (9) through a pipeline and is connected to the pressure buffer bottle (5) through the PID regulating valve (9). The pressure buffer bottle (5) and the liquid accumulation collection bottle (10) are connected through a connecting pipe (11). The capacitive liquid level sensor (3) is installed and inserted into the liquid accumulation collection bottle (10). The liquid accumulation collection bottle (10) is threadedly connected to the micro flow sensor (2). The micro flow sensor (2) is threadedly connected to a disposable drainage tube (12). The disposable drainage tube (12) is connected to a puncture needle (13). The micro pressure sensor array (1) is installed at the needle end of the puncture needle (13). The micro pressure sensor array (1) is connected to a signal transmitter (14) through a wire. The signal transmitter (14) is clamped to the tail end of the puncture needle (13) through a clamping block. The puncture needle (13) is provided with an annular groove (21) corresponding to the micro pressure sensor array (1). The puncture needle (13) is provided with a spiral wire groove (22); The usage method includes the following steps: S1: Preoperative preparation: Check the device. Each component has no physical damage, and the power of each power supply module is greater than or equal to 80%. Ensure that the drainage tube and the puncture needle have completed low-temperature plasma sterilization. Connect the liquid accumulation collection bottle (10) and the pressure buffer bottle (5) through the connecting pipe (11). Threadedly connect the capacitive liquid level sensor (3) to the liquid accumulation collection bottle (10), and insert the detection end into the liquid accumulation cavity (16). Connect the micro flow sensor (2) to the liquid accumulation collection bottle (10), then connect the disposable drainage tube (12) to the micro flow sensor (2), and connect the puncture needle (13) to the disposable drainage tube (12) to complete the preparation work of the device; S2: Patient evaluation and mode selection: Determine the type of fluid accumulation (pericardial / pleural) and estimate the amount of fluid accumulation according to imaging examinations (such as ultrasound, CT). Select the corresponding mode on the medical touch screen (6): Pericardial mode: The default maximum daily drainage volume is 200 mL, and the pressure drop rate is ≤5 mmHg / min. Pleural mode: The default maximum daily drainage volume is 1.5 L, and the pressure drop rate is ≤10 mmHg / min; S3: Device initialization: Place the puncture needle (13) in a physiological saline environment, and perform zero calibration of the micro flow sensor (2) and baseline calibration of the capacitive liquid level sensor (3), Start the brushless DC micro vacuum pump (4) to preheat for five seconds, initialize the PID regulating valve (9), and pre-charge the pressure buffer bottle (5) to the ambient pressure; S4: Drainage operation: Insert the puncture needle (13) into the pericardial or pleural effusion cavity under ultrasound guidance, ensure that the micro pressure sensor array (1) is located in the effusion area, observe the pressure waveform feedback by the signal transmitter (14) in real time through the medical touch screen (6), confirm that the sensor signal is stable, the signal fluctuation < ±1 mmHg, start the adaptive drainage, start the drainage operation at the medical touch screen (6), and the central processing module performs the following operations:

1. Initial negative pressure setting: Automatically load the preset value according to the type of effusion (pericardium: 50 - 80 mmHg; pleura: 20 - 50 mmHg); 2. Dynamic adjustment: The LSTM algorithm analyzes the time-series data of pressure (P), flow rate (F), and effusion volume (V) in real time, predicts the optimal negative pressure value (P_target), and the brushless DC micro vacuum pump (4) and the PID regulating valve (9) are linked to maintain the pressure of the pressure buffer bottle (5) within the range of P_target ± 2 mmHg; S5: Risk monitoring and intervention: If the vacuum pump speed drops to 50%, and there is a sudden pressure drop (ΔP > 10 mmHg / 10 s), the system immediately pauses the suction and starts the pressure compensation, injects 5 mL of sterile air buffer, automatically terminates when the preset safe drainage volume is reached, and manual intervention is performed. Medical staff can manually override the automatic mode to temporarily adjust the negative pressure or terminate the drainage; S6: Drainage termination and data archiving: The system automatically terminates when the preset safe drainage volume is reached or the intracavitary pressure returns to the physiological baseline: pericardium: 5 - 15 mmHg (normal pericardial pressure), pleura: -5 to +5 mmHg (normal pleural pressure), manually terminate the operation, turn off the brushless DC micro vacuum pump (4), release the residual negative pressure of the PID regulating valve (9), and the central processing module generates a drainage report including the pressure-time curve and the cumulative drainage volume; S7: Postoperative treatment: Clean and maintain the equipment, clean and perform performance tests on the reusable components, monitor the patient, and closely observe the vital signs of heart rate and blood oxygen saturation within 4 hours after the operation to check for signs of re-expansion pulmonary edema or cardiac tamponade.

2. The fluid drainage and extraction device according to claim 1, wherein In S2, the mode switch is restricted, the pericardial and pleural modes cannot be used interchangeably, and the system needs to be completely reset and recalibrated before switching.

3. The liquid accumulation drainage and extraction device according to claim 1, characterized in that Both the signal transmitter (14) and the capacitive liquid level sensor (3) are provided with an internal power supply module and a signal transmission module, and the internal power supply module of the signal transmitter (14) supplies power to the micro pressure sensor array (1) through a wire.

4. The fluid drainage and extraction device according to claim 1, characterized in that, A partition plate (15) is installed in the effusion collection bottle (10), there are two partition plates (15), and the two partition plates (15) divide the effusion collection bottle (10) into an effusion collection chamber (16), a buffer chamber (17), and an air extraction chamber (18), and a one-way valve (19) is installed on one side of the partition plate (15).

5. The fluid drainage and extraction device according to claim 1, characterized in that The detection end of the capacitive liquid level sensor (3) is inserted into the liquid accumulation collection cavity (16), the connecting pipe (11) communicates with the air extraction cavity (18), and the liquid accumulation collection bottle (10) is provided with a scale table (20) corresponding to the liquid accumulation collection cavity (16).

6. The liquid accumulation drainage and extraction device according to claim 1, wherein, The position where the annular groove (21) is opened is 0.5 - 1.5 cm away from the pipe orifice. There are six micro pressure sensor arrays (1), which are arranged evenly. The micro pressure sensor arrays (1) are installed in the annular groove (21) by medical epoxy resin glue.

7. The liquid accumulation drainage and extraction device according to claim 1, characterized in that, The micro pressure sensor arrays (1) are connected to the signal transmitter (14) through wires. The annular groove (21) and the spiral wire groove (22) are both covered with a medical grade silicone layer (23) by micro injection molding process.

8. The liquid accumulation drainage and extraction device according to claim 7, wherein The medical grade silicone layer (23) of the annular groove (21) is provided with micro pressure balance holes corresponding to the detection ends of the micro pressure sensor arrays (1), and the detection ends of the micro pressure sensor arrays (1) penetrate through the micro pressure balance holes.

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