A cerebrospinal fluid leakage control device integrating drainage and compression and a control method thereof

Abstract

The present application relates to a kind of integrated cerebrospinal fluid leakage control pressure device and control method of drainage compression, the cerebrospinal fluid leakage control pressure device includes: the control module capable of switching and running in drainage mode or pressurization mode;For the pressurization of cerebrospinal fluid leakage site is carried out Pressure bag;For the first pressure sensor for sensing the internal pressure of pressure bag;For the second pressure sensor for sensing the body surface contact pressure of pressure bag applied on body surface;Control module and first pressure sensor and second pressure sensor electric signal connection.In drainage mode, control module obtains cerebrospinal fluid drainage discharge capacity and calculates patient's physiological parameters accordingly;When switching from drainage mode to pressurization mode, control module generates preset target pressure in pressurization mode based on physiological parameters calculation;In pressurization mode, control module adjusts the pressure of pressure bag according to the ratio of body surface contact pressure and internal pressure, to regulate internal pressure to preset target pressure and make the ratio satisfy preset fitting condition.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a cerebrospinal fluid leakage control device and control method that integrates drainage and compression. Background Technology

[0002] Cerebrospinal fluid leakage is a common complication after posterior spinal surgery (such as posterior thoracic decompression). If postoperative cerebrospinal fluid leakage persists and is not effectively controlled, it can easily lead to serious complications such as low intracranial pressure syndrome, subcutaneous effusion, and even retrograde infection of the central nervous system. In existing clinical nursing and treatment protocols, it is typically divided into two key stages: "drainage before extubation" and "pressure administration after extubation." On the one hand, during the drainage phase before extubation, drainage tubing needs to be left in place to drain cerebrospinal fluid and reduce the pressure differential at the rupture site. For example, CN106730055A discloses a drainage device for cerebrospinal fluid leakage after spinal surgery, which switches between positive and negative pressure drainage by detecting the specific gravity of the drainage fluid. However, such pure drainage solutions only focus on fluid guidance during the drainage phase and cannot obtain the patient's individualized physiological regulation parameters during drainage, let alone continue or transfer the physiological data from the drainage phase to subsequent treatment phases.

[0003] On the other hand, during the pressurization phase after drainage tube removal, it is necessary to increase the surface and epidural pressure through local physical pressurization (such as a pressure balloon) to close the leakage channels. For example, CN113180917A discloses a pressure abdominal binder device after cesarean section, which uses a controller to control the inflation unit to inflate the balloon based on the pressurization pressure detected by a sensor; CN209490173U discloses a pressure bandage device for cerebrospinal fluid leakage after lumbar spine surgery, which achieves local physical pressurization through a pressure pad and restraint strap. However, existing pressurization and pressure control schemes have the following prominent drawbacks: First, the two-stage treatment is severely fragmented, lacking cross-stage parameter transfer. In existing technologies, the drainage pressure control before extubation and the physical pressurization after extubation are two completely isolated stages. The initial target pressure for pressurization after extubation is often set solely based on the experience of medical staff, which is highly arbitrary and cannot be accurately and automatically adjusted according to the individualized physiological parameters measured by the patient during the drainage stage. This can easily lead to insufficient or excessive pressurization.

[0004] Second, single-modal pressure sensing has limitations, failing to distinguish between "false compression" and "local overload." Existing pressurization devices typically rely solely on a single internal pressure sensor within the airbag for closed-loop regulation. However, in actual clinical applications, changes in patient position, loosening of straps, or indentation of anatomical structures can easily lead to "false compression"—where the airbag's internal inflation pressure is sufficient, but the contact surface between the airbag and the body surface is not actually applying effective pressure. Alternatively, the patient lying flat may cause excessive local mechanical stress on the body surface. The pure internal pressure sensing mechanism cannot identify this true pressure state at the body surface, thus leading to pressurization failure or local tissue damage.

[0005] Therefore, how to break down the data gap between the "drainage" and "pressure" stages, achieve cross-stage pressure target setting based on individual patient physiological parameters, and overcome the deficiency of single-modal pressure sensing in being unable to identify the true pressure state on the body surface is a technical problem that urgently needs to be solved in this field.

[0006] Furthermore, on the one hand, there are differences in understanding among those skilled in the art; on the other hand, the applicant studied a large number of documents and patents when making this invention, but due to space limitations, not all details and contents were listed in detail. However, this does not mean that the present invention does not possess the features of these prior art. On the contrary, the present invention already possesses all the features of the prior art, and the applicant reserves the right to add relevant prior art to the background art. Summary of the Invention

[0007] To address the shortcomings of existing technologies, such as the lack of data transmission between the drainage and pressurization stages and the inability of single-modal pressure sensing to identify the true pressure state on the body surface, this invention provides a cerebrospinal fluid leakage control device and method that integrates drainage and compression. The aim is to break down the data gap between the cerebrospinal fluid drainage and post-extubation pressurization stages, achieve cross-stage pressurization target setting based on individual patient physiological parameters, and improve the fit and pressure control accuracy during the body surface pressurization process.

[0008] The first aspect of this invention provides a cerebrospinal fluid leakage control device integrating drainage and compression, comprising: A compression bag used to apply pressure to areas of cerebrospinal fluid leakage; The first pressure sensor is used to sense the internal pressure of the compression airbag; The second pressure sensor is used to sense the surface contact pressure applied to the body surface by the compression airbag; The control module, which is electrically connected to the first pressure sensor and the second pressure sensor, is configured to switch between operating in drainage mode and pressurization mode. In the drainage mode, the control module acquires the cerebrospinal fluid drainage volume and calculates the patient's physiological parameters accordingly. When switching from drainage mode to pressurization mode, the control module calculates and generates a preset target pressure in pressurization mode based on physiological parameters; In pressurization mode, the control module adjusts the pressure of the compression airbag according to the ratio of the surface contact pressure to the internal pressure, so as to regulate the internal pressure to the preset target pressure and make the ratio meet the preset fit conditions.

[0009] The cerebrospinal fluid leakage control device of this invention breaks through the limitation of the prior art where pre-extubation drainage and post-extubation pressurization are mutually exclusive by setting drainage mode and pressurization mode. On the one hand, during the drainage stage, the device automatically acquires the drainage volume and calculates the patient's individual physiological parameters. When switching to pressurization mode, it automatically maps these parameters into a preset target pressure, achieving seamless transfer of treatment data across stages and taking into account both individual matching of the initial pressurization intensity and control of safety limits. On the other hand, in pressurization mode, the device uses the intra-balloon pressure collected by the first pressure sensor and the surface contact pressure collected by the second pressure sensor to form a dual-modal sensing. Based on the ratio of the two and the target pressure, the balloon pressure is adjusted in synergy, taking into account both insufficient surface pressure and local overload. It can accurately identify and eliminate the false compression phenomenon where the balloon inflation pressure reaches the target but the surface is not actually compressed, and can also promptly eliminate the potential damage caused by local pressure concentration. This significantly improves the safety, fit, and control accuracy of cerebrospinal fluid leakage pressurization treatment.

[0010] According to a preferred embodiment, the physiological parameters include the cerebrospinal fluid (CSF) generation rate and the historical resting CSF pressure; the control module calculates and generates a preset target pressure based on the sum of the rate compensation term corresponding to the CSF generation rate, the resting pressure term corresponding to the historical resting CSF pressure, and the reference constant, and the rate compensation term is limited to a preset compensation upper limit.

[0011] The control module performs a linear mapping calculation by combining the measured cerebrospinal fluid production rate with the historical resting pressure and a reference constant to customize the initial target pressure for each patient, eliminating the blindness of setting the pressure based on experience. By setting an upper limit for the rate compensation term, it effectively prevents the calculated target pressure from being too high due to abnormally high drainage during the drainage period, thus avoiding the risk of excessive compression on the local skin and deep tissues.

[0012] According to a preferred embodiment, in pressurization mode, when the ratio is less than a first preset ratio threshold and continues to reach a first preset duration threshold, the control module determines that the current state is a pseudo-compression state and controls the inflation of the compression airbag; when the ratio is greater than a second preset ratio threshold and continues to reach a second preset duration threshold, the control module determines that the current state is a local pressure overload state and controls the smooth deflation of the compression airbag.

[0013] The control module determines false compression and drives inflation based on a ratio below the first threshold and the duration condition is met. This can promptly reconstruct the pressure on the body surface and prevent pressurization failure due to loosening of the straps or changes in body position. Based on a ratio above the second threshold, it determines local pressure overload and drives smooth deflation, which can effectively buffer local concentrated stress caused by the patient lying flat or being compressed in a certain position, and avoid rapid decompression that could cause drastic fluctuations in intracranial pressure.

[0014] According to a preferred embodiment, the cerebrospinal fluid leakage control device further includes a drainage component and a pneumatic actuator connected to the control module via an electrical signal; the drainage component includes a drainage tube connected to the patient's cerebrospinal fluid drainage site, a liquid pressure sensor disposed on the drainage tube, and a drainage drive component; the control module controls the operation of the drainage drive component based on the pressure collected by the liquid pressure sensor to calculate the cerebrospinal fluid drainage volume; the pneumatic actuator is connected to the compression airbag, and the control module controls the inflation and deflation of the pneumatic actuator in pressurization mode to adjust the pressure of the compression airbag.

[0015] The drainage component utilizes a liquid pressure sensor to control the drainage drive in a closed loop and calculates the discharge volume based on the operating status, ensuring the accuracy and automation of the drainage discharge volume measurement data. The gas path actuator works in conjunction with the control module to complete the inflation and deflation actions, providing a stable and reliable physical execution basis for the dynamic fine-tuning and ratio closed-loop control of the airbag pressure in pressurization mode.

[0016] According to a preferred embodiment, the cerebrospinal fluid leakage control device further includes a fixation strap for wearing and securing, with a compression airbag disposed inside the back panel of the fixation strap; an avoidance notch is provided at the upper edge of the back panel, and three independently disposed elastic bandages extend from both sides of the back panel; an auxiliary airbag that can be independently and manually inflated and deflated can also be detachably fixed inside the back panel to fill anatomical depressions on the body surface and increase comfort.

[0017] The avoidance notch in the main back panel works in conjunction with three independent elastic bandages to effectively avoid sensitive tissues such as the chest and form multi-point dispersed restraint on the body surface, improving wearing comfort; the detachable static auxiliary airbag on the inside can be manually inflated and deflated to fill the anatomical depressions or spinal deformity areas of the patient, creating a flat force base for the compression airbag, improving the uniformity of pressure and wearing comfort.

[0018] According to a preferred embodiment, the control module includes a microcontroller and an overpressure protection device set independently of the microcontroller; the overpressure protection device is electrically connected to a first pressure sensor, and when the pressure collected by the first pressure sensor exceeds the hardware safety limit pressure threshold, the overpressure protection device outputs a hardware signal to cut off the pressurization drive power supply and controls the release valve connected to the compression airbag to release pressure.

[0019] The overpressure protection component, independent of the microcontroller, forms a hardware-level safety barrier. When the pressure inside the airbag exceeds the safety limit, the pressurization power supply can be directly cut off and the release valve can be opened to release pressure without relying on software logic. This prevents continuous abnormal inflation caused by the main control chip freezing, program crashes, or sensor malfunctions, thus ensuring the extreme safety of the equipment.

[0020] According to a preferred embodiment, the outer side of the compression airbag is divided into multiple arrayed protrusions; the second pressure sensor is a flexible thin-film piezoresistive sensor, which is attached to the outer surface of the protrusions.

[0021] The compartmentalized blocks on the outside of the airbag form a multi-point array contact structure, which helps to disperse the pressure on the body surface. The flexible thin-film piezoresistive sensor attached to the surface of the block can directly sense the real pressure on the contact surface between the airbag and the skin, avoiding concentrated pressure and discomfort on the patient's skin caused by the hard shell of the sensor.

[0022] The second aspect of the present invention provides a cerebrospinal fluid leakage control method that integrates drainage and compression. In the drainage mode, cerebrospinal fluid drainage is performed, and the patient's physiological parameters are calculated based on the cerebrospinal fluid drainage volume. When switching from drainage mode to pressurization mode that applies pressure to the body surface by compressing airbags, a preset target pressure in pressurization mode is calculated and generated based on the measured physiological parameters. In pressurization mode, the first pressure signal that senses the pressure inside the compression airbag is acquired, as well as the body surface contact pressure signal collected by the flexible sensor attached between the compression airbag and the body surface. Calculate the ratio of surface contact pressure to internal pressure; and The ratio is compared with the preset fitting conditions, and the pressure of the compression airbag is adjusted based on the comparison results to regulate the internal pressure to the preset target pressure and eliminate false compression or local pressure overload.

[0023] The control method of this invention establishes a cross-stage collaborative control system by linking the calculation of physiological parameters during the drainage period with the calculation of target pressure during the pressurization period. During the pressurization period, the pressure inside the airbag and the pressure on the body surface are collected and the ratio between the two is calculated. The ratio is compared with preset conditions to drive the airbag pressure adjustment. This effectively solves the technical problem that single-modal pressure control is difficult to identify pseudo-compression and local pressure overload, and realizes a smooth transition and closed-loop regulation of pressure control throughout the entire process of cerebrospinal fluid leakage.

[0024] According to a preferred embodiment, in pressurization mode, after acquiring the body surface contact pressure signal, a noise reduction and artifact removal step is further included: when the rate of change of the body surface contact pressure signal exceeds a first mutation rate threshold and the rate of change of the first pressure signal is lower than a second mutation rate threshold, it is determined that the current signal jumps to an artifact caused by a change in body position, and the pressure adjustment based on the ratio is paused.

[0025] After acquiring the surface contact pressure signal, noise reduction and artifact removal logic is introduced. By comparing the difference in the rate of change of contact pressure and internal pressure, transient jumps caused by sudden changes in body position are determined, and the adjustment is paused within a preset window. This avoids the system from malfunctioning or frequently ineffective inflation and deflation due to brief changes in body position such as coughing or turning over, thus improving the control stability of the system.

[0026] According to a preferred embodiment, when switching from the diversion mode to the pressurization mode, a hardware self-test step is further included: before running the mapping calculation, the test high voltage is applied and the hardware comparison circuit is detected to trigger a power-off response. If and only if the power-off response is successfully triggered, the hardware self-test is determined to be passed and the system is allowed to enter the pressurization mode.

[0027] When switching from diversion mode to pressurization mode, a hardware self-test is performed. The power failure response capability of the hardware comparison circuit is verified by actively applying a test high voltage. Only after ensuring that the overpressure protection circuit is in good working order is the device allowed to enter pressurization mode, thus preventing operation with defects and improving the system reliability of the device during long-term operation and mode switching. Attached Figure Description

[0028] Figure 1 This is a simplified schematic diagram of the modular connection relationship of a cerebrospinal fluid leakage control system integrating drainage and compression according to a preferred embodiment of the present invention. Figure 2 This is a schematic diagram of the dual-mode operation and mode switching of a cerebrospinal fluid leakage control system integrating drainage and compression according to a preferred embodiment of the present invention. Figure 3 This is a flowchart of a preferred embodiment of the present invention for a cerebrospinal fluid leakage control method integrating drainage and compression.

[0029] List of reference numerals 100: Control module; 110: Microcontroller; 120: Memory; 130: Monitoring unit; 140: Overpressure protection component; 200: Drainage assembly; 210: Drainage tubing; 220: Liquid pressure sensor; 230: Drainage drive component; 300: Compression assembly; 310: Fixing strap; 320: Compression airbag; 330: Pneumatic actuator; 340: First pressure sensor; 350: Second pressure sensor; 400: Human-machine interface module; 410: Display screen; 420: Buttons; 430: Indicator; 440: Buzzer. Detailed Implementation

[0030] The following is a detailed explanation with reference to the accompanying drawings.

[0031] This embodiment provides an integrated intelligent pressure control system with "drainage-compression" dual-mode for patients with cerebrospinal fluid leakage after posterior thoracic spine surgery, such as... Figure 1As shown, the system constructs a closed-loop treatment and nursing chain that extends from the period of dynamic cerebrospinal fluid drainage and physiological parameter measurement during the postoperative indwelling drainage tube period to the period of individualized precision physical pressure application and pseudo-compression identification during the drainage tube removal period.

[0032] like Figures 1-3 As shown, the integrated cerebrospinal fluid leakage control system, combining drainage and compression, mainly consists of four core system modules: a control module 100, a drainage component 200, a compression component 300, and a human-computer interaction module 400. The control module 100 serves as the computing power, decision-making, and physical protection center of the system, with its main control printed circuit board fixed inside a medical protective shell. The control module 100 includes a microcontroller 110, a memory 120, a monitoring unit 130, and an overpressure protection component 140. The microcontroller 110 is configured as a medical-grade microcontroller based on an ARM Cortex-M4 core, integrating an analog-to-digital converter (ADC). The ADC has a resolution of at least 12 bits, and its sampling frequency is set within a first preset frequency range (in this embodiment, the first preset frequency range is preferably 50Hz to 200Hz, specifically preferably 50Hz). It is used to receive analog voltage signals output from various sensors and perform digital quantization. The memory 120 is a non-volatile memory, specifically a static random access memory (SRAM) or an electrically erasable programmable read-only memory (EEPROM) with power-loss data protection. The memory 120 establishes a bidirectional electrical signal connection with the microcontroller 110 through a communication bus (such as an SPI bus or an I2C bus) to store preset mapping algorithm constants, sliding window filter queues, dynamic calibration bias parameters, patient historical resting cerebrospinal fluid pressure data, and system fault operation logs.

[0033] To establish a hardware-level physical security protection mechanism, a monitoring unit 130 and an overvoltage protection device 140 are installed on the main control printed circuit board of the control module 100, independent of the microcontroller 110. The monitoring unit 130 is specifically a hardware watchdog circuit, configured to receive periodic pulse signals emitted by the microcontroller 110 through general-purpose input / output pins based on a hardware timer circuit. When the microcontroller 110 experiences a program malfunction that causes the pulse signal to stop for a duration reaching a first preset heartbeat timeout threshold, the monitoring unit 130 directly outputs a hardware reset signal to the reset pin of the microcontroller 110 and forcibly cuts off the power supply circuit of the subsequent actuators. In this embodiment, the watchdog feeding cycle of the periodic pulse signals emitted by the microcontroller 110 is set to 1 second. When the microcontroller 110 experiences pulse signal interruption due to high-frequency noise interference or complex program deadlock, and the duration reaches the first preset heartbeat timeout threshold (in this embodiment, the first preset heartbeat timeout threshold is specifically set to 2 seconds), the monitoring unit 130 outputs a hardware reset signal, causing the system to instantly enter a physical security lockout state. The overpressure protection device 140 is specifically a pure hardware voltage comparator circuit built based on a comparator chip (preferably an LM393 comparator chip in this embodiment). The input terminal of the overpressure protection device 140 is directly electrically connected to the analog signal output terminal of the first pressure sensor 340 in the compression assembly 300 via a signal conditioning circuit. Its other input terminal is electrically connected to a high-precision reference voltage source, whose output voltage precisely corresponds to a preset hardware safety limit pressure threshold. In this embodiment, the hardware safety limit pressure threshold is specifically set to 1000 mmH2O. When the analog voltage signal collected and output by the first pressure sensor 340 exceeds the reference voltage, the output terminal of the overpressure protection device 140 instantly transitions from a low level to a high level. This high-level signal is not controlled by the software code of the microcontroller 110 and directly biases and drives the hardware latch circuit to conduct.

[0034] like Figures 1-3As shown, the drainage component 200, as the core execution unit in the drainage mode, is located downstream of the control module 100 and establishes an electrical signal and fluid control connection with the control module 100. The drainage component 200 includes a drainage tube 210, a fluid pressure sensor 220, and a drainage drive component 230. The drainage tube 210 is made of medical-grade high-transparency polyvinyl chloride or silicone material. Its proximal connector is suitable for connecting to the patient's epidural space or lumbar cistern to drain leaked cerebrospinal fluid, and its distal end is connected to a closed one-way valve cerebrospinal fluid collection bag. The fluid pressure sensor 220 is connected in series to the main channel of the drainage tube 210 to sense the hydrostatic pressure inside the tube in real time. To eliminate measurement errors caused by the height difference of the static water column within the tubing, a snap-fit ​​calibration seat is provided on the outer side of the housing of the liquid pressure sensor 220. During use, the calibration seat is rigidly fixed to the infusion stand and aligned horizontally with the patient's external auditory canal using a physical leveling device (such as a bubble level or laser level), ensuring that the measurement zero plane of the liquid pressure sensor 220 is consistent with the height of the patient's intracranial ventricles. The drainage drive 230 is specifically a precision medical peristaltic pump, whose pump head rollers roll in contact with the outer wall of the pump section of the drainage tubing 210, achieving non-invasive fluid compression drive. The pulse width modulation output pin of the microcontroller 110 is electrically connected to the stepper motor control terminal of the drainage drive 230 via a motor drive circuit, used to drive the drainage drive 230 to operate or stop using closed-loop PID control.

[0035] like Figures 1-3As shown, the compression assembly 300 serves as the physical execution unit in the post-extubation pressurization mode, establishing an electrical signal connection with the control output and signal input terminals of the control module 100 and the airway. The compression assembly 300 includes a fixing strap 310, a compression airbag 320, an airway actuator 330, a first pressure sensor 340, and a second pressure sensor 350. The fixing strap 310 is formed by stitching together a non-elastic backplate main body segment and elastic side wings on both sides. The upper edge of the backplate main body segment has an arc-shaped downward recessed avoidance notch at its center. The curvature and depth of the notch are set according to anthropometry data to avoid chest and breast tissue, thus preventing pressure on the chest and breast and avoiding physical discomfort such as chest tightness and shortness of breath, as well as the risk of local skin redness or damage, significantly improving the patient's wearing comfort and compliance. The elastic side wings consist of three elastic bandages that are evenly spaced longitudinally along the edge of the main body segment and extend independently laterally. In terms of structural dimensions, the longitudinal spacing between adjacent elastic bandages is limited to a first preset spacing range (in this embodiment, the first preset spacing range is specifically set to 2cm to 3cm), the longitudinal width of the elastic bandage is limited to a first preset width range (in this embodiment, the first preset width range is specifically set to 2cm to 4cm), and the elastic elongation ratio of its material is limited to a first preset elongation ratio range (in this embodiment, the first preset elongation ratio range is specifically set to 1:1.5 to 1:2.5). When worn, the Velcro at the free end of the elastic bandage is bonded and fixed to the Velcro loop surface of the outer surface of the main body segment, thereby generating multi-point dispersed elastic restraint forces on both sides of the patient's chest and abdomen. For patients with scoliosis or thoracic kyphosis, the inner surface of the backplate main body segment of the fixation strap 310 is provided with a Velcro loop surface corresponding to the concave area of ​​the lower back, and is equipped with a static filling auxiliary airbag that can be detachably fixed thereon. The static filling auxiliary airbag is made of medical-grade thermoplastic polyurethane by hot pressing. One side is provided with a one-way air inlet with a built-in one-way silicone valve and can be detachably connected to a manually inflatable ball. The other side is provided with a push-pull deflation valve. Its minimum contraction area is limited to a first preset contraction area (in this embodiment, the first preset contraction area is specifically set to 3cm×3cm), and its maximum inflation area can reach the first preset expansion area (in this embodiment, the first preset expansion area is specifically set to 10cm×10cm). It is used to independently fill the anatomical depression on the side of the spine and form a flat force-bearing base surface when the nurse manually squeezes the ball to inflate it.

[0036] The compression airbag 320 is fixedly installed on the inner side of the main body of the backplate of the fixing strap 310. The compression airbag 320 adopts a common cavity and physically segmented array structure. Its interior is a single fluid-connected air chamber and only requires one pressure measurement and inflation interface. However, its exterior is divided into independent protruding blocks arranged in a matrix (preferably a 3×3 matrix arrangement in this embodiment) by the internal pull strap heat-fused indentation. This greatly improves the anatomical fit to the patient's back muscles and the physiological curvature of the spine while maintaining the overall internal pressure uniformity. The air circuit actuator 330 includes a miniature electronically controlled inflation pump and a proportional electromagnetic deflation valve, which are airtightly connected to the interface of the compression airbag 320 through a medical air circuit hose. The switch and pulse width modulation pin of the microcontroller 110 are respectively connected to the drive circuit of the inflation pump and deflation valve in the air circuit actuator 330 to realize the inflation of the air circuit, the step-by-step micro-deflation, and the rapid depressurization.

[0037] like Figures 1-3 As shown, the first pressure sensor 340 and the second pressure sensor 350 together constitute the dual-modal sensing network of the system. The first pressure sensor 340 is specifically a microelectromechanical system (MEMS) solid-state pressure sensor, airtightly connected to an airway branch inside the compression airbag 320, used to measure the static pressure of the gas inside the compression airbag 320 (hereinafter referred to as the airbag internal pressure). The second pressure sensor 350 is specifically a flexible thin-film piezoresistive sensor, its thickness limited to a first preset thickness range (in this embodiment, the first preset thickness range can be specifically set to 0.1mm to 0.3mm), attached to the outer surface of the apex of the central matrix protrusion of the compression airbag 320 using medical double-sided adhesive. After the fixation strap 310 is worn, the second pressure sensor 350 is sandwiched between the outer wall of the compression airbag 320 and the patient's wound dressing. Its output resistance change signal, after signal amplification and analog-to-digital conversion sampling, directly reflects the normal contact pressure (hereinafter referred to as the body surface contact pressure) applied by the airbag to the wound dressing. To ensure the physical stability of pressure acquisition, the three elastic bandages extending independently from both sides of the fixing strap 310 and the arc-shaped downward recessed avoidance notch on the upper edge of the main body of the back plate can form multi-point dispersed restraint when the compression airbag 320 is inflated, thereby firmly and flatly fixing the compression component 300 to the patient's lower back. At the same time, the first pressure sensor 340 is airtightly connected to the compression airbag 320 with multiple protrusions through an airway branch, and the second pressure sensor 350, which is attached to the outer surface of the apex of the central protrusion, can directly sense the real body surface contact pressure when the compression airbag 320 is inflated. The two work together to complete the synchronous acquisition of dual-modal pressure.

[0038] The human-machine interface module 400 serves as the input and status awareness interface for medical staff and patients, establishing bidirectional electrical signal communication with the microcontroller 110 via a serial communication interface (such as a UART interface). The human-machine interface module 400 includes a display screen 410, buttons 420, indicators 430, and a buzzer 440. The display screen 410 is an LCD touchscreen used to display the current operating mode, real-time collected cerebrospinal fluid pressure, individualized cerebrospinal fluid generation rate, cuff pressure, surface contact pressure, and preset center pressure value in real time. The buttons 420 include physical plus / minus buttons, a confirmation button, a separately set "one-key pressure release" physical button, and a "hardware reset" physical button electrically connected to the overpressure protection device 140. The indicators 430 are multi-color light-emitting diode indicators (preferably a multi-color LED indicator array including green, yellow, red, and orange lights in this embodiment), used in conjunction with the buzzer 440 to achieve hierarchical closed-loop interaction.

[0039] like Figures 1-3 As shown, when the system operates in drainage mode (mode one) under the control of microcontroller 110, the liquid pressure sensor 220 collects the cerebrospinal fluid pressure signal in the drainage tube 210 in real time at a preset sampling frequency (in this embodiment, the preset sampling frequency is specifically set to 10Hz) and inputs it to microcontroller 110. Microcontroller 110 uses a closed-loop PID control algorithm to compare the real-time cerebrospinal fluid pressure with the target cerebrospinal fluid pressure value preset via button 420. When the real-time cerebrospinal fluid pressure is higher than the sum of the target cerebrospinal fluid pressure value and the upper limit of the control dead zone, microcontroller 110 outputs a drive waveform to activate the drainage drive 230 to rotate forward for drainage; when the real-time cerebrospinal fluid pressure drops to the set control dead zone range, microcontroller 110 controls the drainage drive 230 to stop operating, thereby eliminating the risk of over-drainage or under-drainage often caused by gravity drainage.

[0040] During the preset observation period of the drainage phase, the control module 100 calculates the patient's total drainage volume by accumulating the rotational displacement of the drainage drive 230, and calculates the individualized cerebrospinal fluid generation rate based on the ratio of the total drainage volume to the preset observation period. Specifically, the microcontroller 110 starts its internal counter during the stable drainage observation period (in this embodiment, the preset observation period is specifically set to 2 consecutive hours), calculates the total drainage volume by accumulating the number of rotational pulses of the drainage drive 230 during the observation period, and combines this with the single-turn fixed displacement constant stored in the memory 120, and then calculates the individualized cerebrospinal fluid generation rate (denoted as ) according to the formula. Furthermore, at the end of the closure test period before drainage tube removal, the microcontroller 110 controls the fluid pressure sensor 220 to collect pressure data and calculate its arithmetic mean, which serves as the patient's historical resting cerebrospinal fluid pressure (denoted as ). The individualized cerebrospinal fluid production rate and historical resting cerebrospinal fluid pressure are written into memory 120 and latched.

[0041] When the system switches from drainage mode to pressurization mode (mode two), the control module 100 first executes a hardware self-test program. Specifically, the microcontroller 110 sends a test pulse to the air pump in the gas path actuator 330, causing it to establish an instantaneous test high pressure in the blocked gas path, and then detects whether the overpressure protection device 140 has successfully flipped its level and output a hardware power-off signal. Only if the self-test passes successfully can the microcontroller 110 load and execute the mapping algorithm; if the self-test fails, the program startup is blocked and a fault code is displayed on the display screen 410. After the self-test passes, the control module 100 calls the individualized mapping algorithm pre-installed in the memory 120, and derives the initial safe preset center pressure value (denoted as ) in pressurization mode based on the latched historical resting cerebrospinal fluid pressure and individualized cerebrospinal fluid generation rate. The mapping algorithm is configured as follows:

[0042] In the above mapping formula, α represents the baseline constant, which is preset within a first preset baseline range (in this embodiment, the baseline constant is fixed at 200 mmH2O, serving as the minimum intervention threshold for pressurized operation, ensuring that cerebrospinal fluid leakage will not be induced due to epidural pressure being lower than subarachnoid pressure under any circumstances); α represents the resting pressure weighting coefficient, which is preset within a first preset weighting range (in this embodiment, the preset range of α is 0.5 to 1.0, with a preferred value of 0.8); β represents the secretion compensation weighting coefficient, which is preset within a second preset weighting range (in this embodiment, the preset range of β is 1.0 to 2.0, with a preferred value of 1.5). The linear rate compensation function representing the dead zone is based on a preset cerebrospinal fluid production rate threshold (denoted as ). In this embodiment, the specific flow rate is set to 20 ml / h, and the conversion factor is denoted as... In this embodiment, the segmented expression relationship is specifically established as 2 mmH2O / (ml / h): when hour, ;when hour, .

[0043] To prevent excessively high calculated target pressure values ​​due to extremely abnormal drainage data, the control module 100 further incorporates a limiting protection mechanism in the mapping algorithm. Specifically, the compensation term for cerebrospinal fluid generation rate in the mapping algorithm is limited by a first preset compensation upper limit (in this embodiment, the first preset compensation upper limit is denoted as...). Specifically set at 100 mmH2O), and the final derived initial safety preset center pressure value is limited to not exceeding the first maximum safety threshold (in this embodiment, the first maximum safety threshold is denoted as...). Specifically, it is set to 400 mmH2O. When the algorithm-calculated value exceeds the first maximum safe threshold, the microcontroller 110 forcibly... The threshold is locked, and a high-risk rupture warning pops up on display screen 410. Through the above logic, the system algorithm combines the initial physical reference constant obtained by equivalent somatosensory calibration with the patient's individual cerebrospinal fluid production rate and historical resting pressure. While using the limiting threshold to prevent excessive pressure due to abnormal drainage, it calculates a target pressure that matches the patient's actual situation, eliminating the risk of tissue damage caused by blindly applying pressure.

[0044] It should be noted that the core principle of traditional local pressure treatment for cerebrospinal fluid leakage wounds is to increase the epidural space pressure by applying local physical pressure, so that the epidural pressure approaches or exceeds the subarachnoid space pressure, thereby blocking the outflow of cerebrospinal fluid and creating a suitable mechanical environment for dural repair.

[0045] Currently, local compression is typically achieved clinically using a combination of gravity sandbags and abdominal binders. However, in this traditional method, the sandbag's compression mechanism is primarily based on unidirectional downward gravity, and combined with the passive wrapping of the abdominal binder, it remains a passive local compression. The effective pressure applied to the epidural space is easily affected by changes in patient position (e.g., supine, lateral), the contact area with the body surface, and the physical displacement of the sandbag, leading to a certain attenuation or shift in the effective stress acting on the leakage site. In contrast, the compression airbag 320 of this invention provides compression within a closed fluid cavity under the elastic constraint of the fixing strap 310. Its force mechanism is based on multidirectional isotropic expansion compression of hydrostatic pressure, which can form a uniform wrapping normal stress along the anatomical curvature of the patient's lumbar and back muscles and spine. Because the unidirectional gravity compression of the gravity sandbag and the multidirectional isotropic expansion compression of the compression airbag 320 have fundamental physical differences in force path, deformation constraint, and stress transmission mechanism, they cannot be directly linearly equivalently converted using a simple gravity-pressure formula. Therefore, this invention uses a mapping algorithm derived by combining individualized cerebrospinal fluid physiological parameters measured during the drainage period, and combines the intra-bag pressure sensed by the first pressure sensor 340 and the surface contact pressure sensed by the second pressure sensor 350 to form a dual-modal closed-loop control. This overcomes the technical bias that traditional sandbag gravity compression cannot be directly converted into airbag control parameters, and allows for setting a preset center pressure value in the pressurization mode. It also provides physical, mechanical, and clinical evidence to limit the dynamic safety control range of 200-800 mmH2O.

[0046] Upon entering pressurization mode, the control module 100 first performs zero-point calibration and noise reduction on the second pressure sensor 350. Specifically, when the fixation strap 310 is worn and the compression airbag 320 is in an uninflated state, the microcontroller 110 acquires the static voltage signal of the second pressure sensor 350 and calculates the reference bias. Subsequently acquired surface contact pressure signals are all deducted from this reference bias and mapped to pressure units (mmH2O) with the same dimensions as the first pressure sensor 340 using a pre-stored fitting gain coefficient. During continuous sampling, the microcontroller 110 establishes a cyclic first-in-first-out (FIFO) queue of a specific length and executes a sliding window midpoint filtering algorithm: after removing extreme data within the sampling window, the arithmetic mean is calculated as the effective discrimination pressure at the current moment. Furthermore, when the microcontroller 110 detects that the rate of change of the output of the second pressure sensor 350 exceeds the first abrupt change rate threshold (in this embodiment, the first abrupt change rate threshold is specifically set to 30 mmH2O / s), while the rate of change of the output of the first pressure sensor 340 is lower than the second abrupt change rate threshold (in this embodiment, the second abrupt change rate threshold is specifically set to 5 mmH2O / s), the microcontroller 110 determines that the signal jump is an artifact caused by a sudden change in body position, thereby triggering the body position change protection, suspending the automatic adjustment action of the pneumatic actuator 330 until the first pause adjustment duration threshold is reached (in this embodiment, the first pause adjustment duration threshold is specifically set to 5 seconds), and presenting a warning indication (such as a yellow light flashing for 3 seconds) on the indicator 430.

[0047] After obtaining the effective filtered pressure, the control module 100 performs multimodal quantization discrimination and closed-loop control based on the airbag internal pressure and the body surface contact pressure. When the ratio of the body surface contact pressure to the airbag internal pressure is greater than or equal to a first preset ratio threshold (in this embodiment, the first preset ratio threshold is specifically set to 0.7), and this state continues to reach a first preset duration threshold (in this embodiment, the first preset duration threshold is specifically set to 5 seconds), the control module 100 determines that the current pressure fit is good, the control module 100 controls the air path actuator 330 to remain in the off state, and controls the indicator 430 to display a first preset indication state (such as a constantly lit green light). If at this time the airbag internal pressure is lower than the preset center pressure value and the lower limit of the control dead zone (in this embodiment, the control dead zone is set to...), the control module 100 will not perform the control control. The microcontroller 110 drives the air pump to replenish a small amount of air into the dead zone.

[0048] Conversely, when the pressure inside the airbag reaches the preset center pressure value, but the ratio of the body surface contact pressure to the pressure inside the airbag is less than the second preset ratio threshold (in this embodiment, the second preset ratio threshold is specifically set to 0.5), and this state continues for a second preset duration threshold (in this embodiment, the second preset duration threshold is specifically set to 3 seconds), the control module 100 determines that the system is in a false compression state. The control module 100 outputs a control command to drive the air pump in the air path actuator 330 to perform forced supplemental inflation, using the expansion of the outer bulge of the airbag 320 towards the body surface to fill the gap in the body depression, thereby rebuilding the effective compression force until the ratio recovers to be greater than or equal to the first preset ratio threshold; if the continuous inflation time reaches the first preset inflation timeout duration threshold (in this embodiment, the first preset inflation timeout duration threshold is specifically set to 20 seconds) but still does not reach the first preset ratio threshold, the control module 100 triggers a strap detachment alarm, the control indicator 430 flashes a red light and drives the buzzer 440 to sound an alarm continuously.

[0049] When the ratio of the surface contact pressure to the airbag pressure is greater than the third preset proportional threshold (in this embodiment, the third preset proportional threshold is specifically set to 1.2), and this state continues to reach the third preset duration threshold (in this embodiment, the third preset duration threshold is specifically set to 2 seconds), the control module 100 determines that the system is in a local pressure overload state. To prevent rapid degassing from causing serious complications, the control module 100 triggers a stepped smooth degassing procedure, controlling the proportional electromagnetic degassing valve in the air circuit actuator 330 to operate in a periodic micro-degassing mode. By compressing the airbag 320 to release a small amount of air, the volume is reduced to alleviate local pressure concentration, and the overall average degassing rate is controlled not to exceed the first maximum allowable degassing rate threshold (in this embodiment, the first maximum allowable degassing rate threshold is specifically set to 1.7 mmH2O / s), until the ratio of the surface contact pressure to the airbag pressure drops to less than or equal to the fourth preset proportional threshold (in this embodiment, the fourth preset proportional threshold is specifically set to 1.1) or the airbag pressure reaches the minimum safe lower limit. During this period, the control module 100 controls the indicator 430 to flash red and orange alternately, and drives the buzzer 440 to emit intermittent beeps.

[0050] When the control module 100 detects that the slopes of the data changes from the first pressure sensor 340 and the second pressure sensor 350 are opposite in polarity, and this state continues to reach a fourth preset time threshold (in this embodiment, the fourth preset time threshold is specifically set to 5 seconds), the control module 100 determines that the second pressure sensor 350 has malfunctioned. At this time, the control module 100 automatically blocks the data from the second pressure sensor 350, downgrades to a single-mode mode that relies solely on the first pressure sensor 340 for basic pressure control, and controls the indicator 430 to illuminate an orange fault light, while simultaneously recording an error log in the memory 120.

[0051] During pressurization, when the pressure value corresponding to the analog signal collected by the first pressure sensor 340 exceeds the hardware safety limit pressure threshold (1000 mmH2O), the overpressure protection device 140 outputs a level transition signal to trigger the hardware latch circuit. This instantly lowers the gate potential of the air pump power supply transistor to cut off the main power supply circuit of the air pump, and simultaneously de-energizes and releases the normally open overpressure safety release valve to open the air path to the atmosphere. At the same time, it drives the indicator 430 and the buzzer 440 to issue a pure hardware audible and visual alarm. After the hardware latch is triggered, the overpressure protection device 140 can only be unlocked after the "hardware reset" button in the manual trigger button 420 clears the latch level of the hardware latch circuit.

[0052] For patients with scoliosis or thoracic kyphosis, before installing the fixation strap 310, the nurse attaches the static filling auxiliary airbag to the corresponding recessed area on the inner surface of the main body of the back plate of the fixation strap 310, and injects gas through the one-way air inlet using a manual inflation balloon. This causes the airbag to expand and fill the anatomical recess between the first preset contraction area (3cm × 3cm) and the first preset expansion area (10cm × 10cm), forming a flat, load-bearing surface. The static filling auxiliary airbag is used as a static physical adjustment component independent of the air path controlled by the control module 100.

[0053] To verify the safety and effectiveness of the system parameter settings, refer to the comparison data of mechanical and safety parameters of clinically mature balloon and airway devices shown in Table 1: Table 1. Comparison of Mechanical Safety Parameters between This System and Clinically Mature Airbag / Airway Devices

[0054] Analysis shows that the extremely fragile tracheal mucosa can withstand continuous pressure of 250-300 mmH2O for extended periods, while the dense muscles and skin of the chest and back have a significantly higher tolerance than the tracheal mucosa. The safe operating range for the pressurization mode of this system is set at 200-800 mmH2O (only 29.4% of the upper limit of 2720 mmH2O for air wave therapy devices), with a maximum safe limit threshold. The hardware overpressure cutoff threshold is 1000 mmH2O, which proves that the algorithm output and hardware threshold of this system have sufficient clinical safety redundancy.

[0055] Furthermore, to provide direct clinical evidence for setting the initial center pressure value of the pressurization mode in this invention, and to establish an equivalent mapping relationship between traditional sandbag gravity compression and airbag fluid compression, this invention provides a calibration method for the effectiveness of compression pressure and the perceived equivalent gradient. Specifically, this calibration method includes the following steps: The first step is to establish a baseline sensation: Select multiple (e.g., 5 to 10) healthy volunteers and apply standard weight (e.g., 1 kg) of medical sandbags to the target area in the two standard positions of prone and lateral prone, so that the test subjects can establish a baseline sensation of pressure from the sandbags.

[0056] The second step is gradient inflation comparison: The sandbag is removed and the compression assembly of this invention is worn. The control module drives the air circuit actuator to inflate from an initial safety reference (preferably 50 mmH2O), and gradually increases the internal pressure of the airbag at a preset gradient (preferably 10-20 mmH2O). During this process, the system strictly limits the maximum pressure of a single inflation (not exceeding 800 mmH2O) and immediately performs deflation and pressure reduction upon receiving abnormal feedback.

[0057] The third step is equivalent interval calibration: Under each increasing gradient, the airbag pressure values ​​are recorded when the test subject's perceived pressure is "significantly lighter than the sandbag," "close to the sandbag," and "significantly heavier than the sandbag." To eliminate random errors from a single measurement, this comparison process is repeated multiple times (e.g., 3 times), and the arithmetic mean of the "close to the sandbag" pressure values ​​is calculated to calibrate the equivalent pressure interval for the corresponding body position.

[0058] Step 4, Clinical reference value extraction: After completing the above tests, extract the minimum effective value among all test subjects’ pressure values ​​that “approach the feeling of pressure from the sandbag”, and solidify it as the safety benchmark reference value for the initial preset center pressure value in subsequent clinical pressure treatment.

[0059] To more intuitively illustrate the execution process and data acquisition architecture of the above-mentioned somatosensory equivalence calibration experiment, the following table presents the recording and calculation dimensions of the experimental data: Table 2 Data Collection Table for Compression Effectiveness and Perceptual Equivalence Calibration

[0060] After collecting single-sample comparative data from multiple subjects, the system statistically summarizes the data under different body positions and assesses human tolerance and safety during the inflation and pressurization process. Specifically, the data summarization and extraction of initial clinical reference values ​​follow these principles: First, the average of three measurements of the "close" pressure sensation of the sandbag was calculated for all subjects in the prone and lateral prone positions, and the equivalent pressure range of the group in the corresponding positions was obtained. Second, the minimum equivalent average pressure of all subjects in each position was extracted as the initial preset center pressure value for subsequent clinical pressurization mode. Recommended conservative reference starting point; Third, the subjective tolerance feedback of the subjects during the gradient inflation process of 50-800 mmH2O (including whether there was chest tightness, shortness of breath, severe local tenderness or skin redness and damage) was recorded simultaneously to verify the safety and effectiveness of the upper limit of pressure and the step inflation rate.

[0061] The following table presents a visual representation of the calculation dimensions matrix for summarizing data from multiple subjects, comparing postural differences, and assessing safety: Table 3. Summary of Perceived Pressure Equivalence and Clinical Safety Assessment Table

[0062] It should be noted that the specific embodiments described above are exemplary. Those skilled in the art can devise various solutions inspired by the disclosure of this invention, and these solutions all fall within the scope of this invention and its protection. Those skilled in the art should understand that this specification and its accompanying drawings are illustrative and not intended to limit the scope of the claims. The scope of protection of this invention is defined by the claims and their equivalents. This specification contains multiple inventive concepts; terms such as "preferredly," "according to a preferred embodiment," or "optionally" indicate that the corresponding paragraph discloses an independent concept. The applicant reserves the right to file divisional applications based on each inventive concept.

Claims

1. A cerebrospinal fluid leakage control device integrating drainage and compression, characterized in that, include: A compression bag (320) for applying pressure to the site of cerebrospinal fluid leakage. A first pressure sensor (340) is used to sense the internal pressure of the compression airbag (320); The second pressure sensor (350) is used to sense the body surface contact pressure applied by the compression airbag (320) to the body surface; The control module (100), which is electrically connected to the first pressure sensor (340) and the second pressure sensor (350), is configured to switch between operating in drainage mode or pressurization mode. In the drainage mode, the control module (100) acquires the cerebrospinal fluid drainage volume and calculates the patient's physiological parameters accordingly. When switching from the drainage mode to the pressurization mode, the control module (100) calculates and generates a preset target pressure in the pressurization mode based on the physiological parameters; In the pressurization mode, the control module (100) adjusts the pressure of the compression airbag (320) according to the ratio of the body surface contact pressure to the internal pressure, so as to regulate the internal pressure to the preset target pressure and make the ratio meet the preset fitting conditions.

2. The cerebrospinal fluid leakage control device integrating drainage and compression according to claim 1, characterized in that, The physiological parameters include cerebrospinal fluid production rate and historical resting cerebrospinal fluid pressure. The control module (100) calculates and generates the preset target pressure based on the sum of the rate compensation term corresponding to the cerebrospinal fluid generation rate, the resting pressure term corresponding to the historical resting cerebrospinal fluid pressure, and the reference constant, and the rate compensation term is limited by the preset compensation upper limit.

3. The cerebrospinal fluid leakage control device integrating drainage and compression according to claim 1 or 2, characterized in that, In the pressurization mode, When the ratio is less than the first preset ratio threshold and continues to reach the first preset duration threshold, the control module (100) determines that the current state is a false compression state and controls the inflation of the compression airbag (320); When the ratio is greater than the second preset ratio threshold and continues to reach the second preset duration threshold, the control module (100) determines that the current state is a local pressure overload and controls the compression airbag (320) to release air smoothly.

4. The cerebrospinal fluid leakage control device integrating drainage and compression according to any one of claims 1 to 3, characterized in that, It also includes a flow-guiding assembly (200) and a pneumatic actuator (330) that are electrically connected to the control module (100). The drainage assembly (200) includes a drainage tube (210) connecting to the cerebrospinal fluid drainage site of the patient, a liquid pressure sensor (220) disposed on the drainage tube (210), and a drainage drive (230). The control module (100) controls the operation of the drainage drive (230) based on the pressure collected by the liquid pressure sensor (220) to calculate the cerebrospinal fluid drainage volume. The pneumatic actuator (330) is connected to the compression airbag (320), and the control module (100) controls the pneumatic actuator (330) to inflate and deflate in the pressurization mode to adjust the pressure of the compression airbag (320).

5. The cerebrospinal fluid leakage control device integrating drainage and compression according to any one of claims 1 to 4, characterized in that, It also includes a fixation strap (310) for wearing and securing, wherein the compression airbag (320) is disposed inside the back plate main body section of the fixation strap (310); The upper edge of the back panel main body section is provided with an avoidance notch, and three independently set elastic bandages extend from both sides of the back panel main body section; The inner side of the main body of the back plate can also be detachably fixed with an auxiliary airbag that can be independently and manually inflated and deflated, used to fill anatomical depressions on the body surface.

6. The cerebrospinal fluid leakage control device integrating drainage and compression according to any one of claims 1 to 5, characterized in that, The control module (100) includes a microcontroller (110) and an overpressure protection device (140) set independently of the microcontroller (110). The overpressure protection device (140) is electrically connected to the first pressure sensor (340). When the pressure collected by the first pressure sensor (340) exceeds the hardware safety limit pressure threshold, the overpressure protection device (140) outputs a hardware signal to cut off the pressurization drive power supply and controls the release valve connected to the compression airbag (320) to release pressure.

7. The cerebrospinal fluid leakage control device integrating drainage and compression according to any one of claims 1 to 6, characterized in that, The outer side of the compression airbag (320) is divided into multiple arrayed protrusions; The second pressure sensor (350) is a flexible thin-film piezoresistive sensor, which is attached to the outer surface of the protruding block.

8. A method for controlling cerebrospinal fluid leakage and pressure by integrating drainage and compression, characterized in that, In the drainage mode, cerebrospinal fluid drainage is performed, and the patient's physiological parameters are calculated based on the cerebrospinal fluid drainage volume. When switching from the drainage mode to the pressurization mode in which pressure is applied to the body surface by the compression airbag (320), a preset target pressure in the pressurization mode is calculated and generated based on the measured physiological parameters; In the pressurization mode, a first pressure signal that senses the internal pressure of the compression airbag (320) is acquired, and a body surface contact pressure signal collected by a flexible sensor attached between the compression airbag (320) and the body surface is acquired. Calculate the ratio of the surface contact pressure to the internal pressure; as well as The ratio is compared with the preset fitting conditions, and the pressure of the compression airbag (320) is adjusted based on the comparison result to regulate the internal pressure to the preset target pressure and eliminate false compression or local pressure overload.

9. The cerebrospinal fluid leakage control method integrating drainage and compression according to claim 8, characterized in that, In the pressurization mode, after acquiring the body surface contact pressure signal, the process further includes noise reduction and artifact removal steps: When the rate of change of the body surface contact pressure signal exceeds the first abrupt change rate threshold and the rate of change of the first pressure signal is lower than the second abrupt change rate threshold, it is determined that the current signal jumps to an artifact caused by a change in body position, and the pressure adjustment based on the ratio is paused.

10. The cerebrospinal fluid leakage control method integrating drainage and compression according to claim 8 or 9, characterized in that, When switching from the drainage mode to the pressurization mode, a hardware self-test step is also included: Before running the mapping calculation, the system applies a test high voltage and detects whether the hardware comparison circuit triggers a power-off response. If and only if the power-off response is successfully triggered, the system is determined to have passed the hardware self-test and is allowed to enter the pressurization mode.

Images