Self-adaptive inflatable medical protection restraint system and monitoring control method

Abstract

The invention relates to the field of medical instruments, in particular to a self-adaptive inflatable medical protection restraint system and a monitoring control method. The system comprises a restraint strap body, a pneumatic control module, a biological feedback module and a system control module. An air bag array consisting of a plurality of independent air chambers is arranged in the restraint strap body; the pneumatic control module is used for inflating and deflating each air chamber; the biological feedback module is integrated on the belt body, comprises a pressure sensing unit and a blood supply sensing unit, and is used for monitoring and constraining interface pressure and limb blood supply state in real time; and the system control module receives the monitoring data, generates an instruction based on a preset safety parameter, and drives the pneumatic control module to perform self-adaptive pressure adjustment on the specified air chamber. According to the system, through dynamic monitoring and accurate adjustment, the problem that a traditional restraining device is prone to causing compression injury and blood supply disorder is effectively solved, and safety and comfort are remarkably improved.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to an adaptive inflatable medical protective restraint system and a monitoring and control method. Background Technology

[0002] In the field of medical care, especially in settings such as psychiatry and ICUs, the safe restraint of agitated patients or those requiring restricted limb movement is a crucial means of ensuring the smooth progress of treatment and patient safety. Currently, the traditional restraint straps widely used in clinical practice are mostly rigid structures of fixed size, which have many insurmountable drawbacks: their fixing and binding methods cannot adapt to the different limb sizes and activity levels of different patients, easily leading to local pressure concentration. According to an FDA report, the incidence of pressure ulcers caused by traditional restraint straps is as high as 23%, seriously affecting patient comfort and the recovery process; at the same time, rigid restraint is prone to triggering patient resistance, increasing nursing risks; more importantly, existing restraint devices lack the ability to monitor the limb's circulatory status in real time, failing to detect blood supply disorders caused by excessive pressure in a timely manner, often only being noticed after the injury has occurred, delaying intervention.

[0003] In existing technologies, some solutions attempt to improve the adaptability of restraints by using airbag structures. For example, CN202420782929.3 discloses an inflatable protective restraint belt, which uses an air supply tube and an array of airbags inside the restraint belt body to adjust the gap between the restraint belt and the limb by inflating and deflating the airbags, in order to adapt to patients of different weights and cope with conditions such as edema and agitation. However, this solution only achieves basic tightness adjustment function, does not integrate a component for real-time monitoring of the pressure at the airbag-limb interface, and lacks the ability to sense the limb's blood circulation status. It cannot dynamically adjust pressure parameters according to the patient's physiological indicators, and still has the risk of compression injury caused by pressure imbalance. Moreover, its airbags are uniformly inflated and deflated through the air supply tube and connecting tube, without adopting an independent air chamber design, making it difficult to accurately control the pressure requirements of different parts of the limb. It cannot fundamentally solve the core problem caused by the lack of dynamic monitoring and adaptive adjustment capabilities of traditional restraint belts. Therefore, how to provide a medical protective restraint system that can monitor restraint pressure and limb blood circulation status in real time and achieve precise adaptive pressure adjustment based on monitoring data has become an urgent technical problem to be solved. Summary of the Invention

[0004] This invention provides an adaptive inflatable medical protective restraint system and a monitoring and control method, aiming to solve the problems caused by the lack of dynamic monitoring and adaptive adjustment capabilities of traditional restraint belts.

[0005] To achieve the above objectives, the following technical solution is adopted.

[0006] An adaptive inflatable medical protective restraint system, comprising: The restraint belt contains an array of airbags with multiple independent air chambers. A pneumatic control module, fluidly connected to the airbag array, is used to inflate and deflate the individual air chambers; A biofeedback module, integrated into the restraint band and used to contact the limb, includes a pressure sensing unit for monitoring the pressure at the interface between the independent air chamber and the limb and a blood flow sensing unit for monitoring the blood flow status of the limb. In addition, a system control module is connected to the pneumatic control module and the biofeedback module respectively; wherein, the blood flow sensing unit is a multi-parameter sensor based on photoplethysmography, which includes at least two light emitters of different wavelengths and corresponding light receivers, the light emitters and light receivers being disposed inside the airbag array and used to conform to the limb skin in the inflated state; The system control module is configured to perform the following operations: receive interface pressure data from the pressure sensing unit and receive raw optical signals obtained from the blood circulation sensing unit by acquiring photoplethysmography pulse wave signals; process and analyze the raw optical signals to simultaneously calculate limb pulse waveform data, blood oxygen saturation data, and characteristic parameters for calculating blood pressure; and generate control commands based on preset safe pressure ranges, blood oxygen saturation thresholds, and blood pressure parameter thresholds to drive the pneumatic control module to adaptively adjust the pressure of the designated independent air chamber.

[0007] Optionally, the pneumatic control module includes: The multi-way air valve unit has a common air port and multiple independent control air ports, and the multiple independent control air ports are connected to the independent air chambers in the airbag array one by one through fluid passages. A pressure regulating unit, connected to the common air port, is used to provide positive or negative pressure; The system control module controls the opening and closing of each valve in the multi-channel air valve unit to selectively fill or release air into designated independent air chambers; and... When the system control module uses the blood flow sensing unit to measure blood pressure, it coordinates and controls the pressure regulation unit and the multi-way valve unit to apply a changing pressure to the target independent air chamber, while recording the corresponding pulse wave signal change trend. By analyzing the relationship between the pulse wave amplitude and the air chamber pressure, the reference values ​​of systolic and diastolic blood pressure are determined.

[0008] Optionally, the pneumatic control module further includes an overpressure protection unit, which is used to perform mechanical automatic pressure relief when the pneumatic control module fails or the system pressure exceeds a first safety threshold. The overpressure protection unit is integrated on the constraint belt and is directly connected to at least one of the independent air chambers. Its pressure relief action is independent of the electrical control circuit of the system control module, providing a redundant safety mechanism.

[0009] Optionally, the system control module calculates blood oxygen saturation by controlling two light emitters of different wavelengths in the blood circulation sensing unit to emit light alternately and receive corresponding transmitted or reflected light signals, calculating the ratio of the AC and DC components of the two wavelength light signals, and obtaining the blood oxygen saturation value based on a pre-calibrated blood oxygen saturation curve; the blood oxygen saturation value and the pulse waveform data originate from the synchronous processing of the same set of optical signals.

[0010] Optionally, the system control module is further configured to perform gradient pressure control: during the initial inflation or pressure maintenance phase, the pneumatic control module is controlled to ensure that the internal pressure of the independent air chamber located in the distal region of the limb is higher than that of the independent air chamber located in the proximal region of the limb; this gradient pressure control strategy is correlated with real-time monitored blood pressure and blood oxygen saturation data, and when the blood oxygen saturation is below a threshold or the blood pressure parameter is abnormal, the system control module dynamically adjusts the distribution or overall level of the gradient pressure.

[0011] Optionally, the biofeedback module and the system control module transmit data via a wireless communication unit; the wireless communication unit further packages and transmits the blood oxygen saturation data, blood pressure parameters, pulse waveform data, and interface pressure data to an external monitoring terminal; the system control module is further used to generate a graded alarm signal and send it to the external monitoring terminal via the wireless communication unit when the blood oxygen saturation data or blood pressure parameters exceed the safe range, while simultaneously driving the pneumatic control module to perform targeted pressure adjustment.

[0012] Optionally, the targeted pressure regulation performed by the system control module includes at least one of the following: when blood oxygen saturation continues to decrease, instructing the pneumatic control module to reduce the pressure of all independent air chambers; when blood pressure parameters indicate insufficient perfusion at the extremities, instructing the pneumatic control module to adjust the gradient pressure distribution to reduce the pressure difference between the distal and proximal ends; the graded alarm signal is divided into different warning levels according to the magnitude of the decrease in blood oxygen saturation or the duration of abnormal blood pressure.

[0013] Optionally, the system further includes an automatic calibration unit connected to the system control module. The automatic calibration unit is configured to perform a calibration process for the biofeedback module during system power-on initialization or periodic self-test. The calibration process includes: calibrating the zero point of the pressure sensing unit under no-load conditions; controlling the pneumatic control module to generate a series of known reference pressures in a specific independent air chamber to calibrate the sensitivity of the pressure sensing unit; and calibrating the optical signal reference of the blood circulation sensing unit under standard test conditions to ensure the accuracy of blood oxygen saturation and blood pressure characteristic parameter calculations.

[0014] Optionally, the restraint band includes an outer protective layer, an airbag support layer, and a skin-friendly inner layer stacked sequentially from the outside to the inside; the airbag support layer is provided with the airbag array, and the skin-friendly inner layer is a breathable mesh fabric with a three-dimensional structure; the light emitter and light receiver of the blood circulation sensing unit are sealed and embedded in the skin-friendly inner layer, and its optical window is flush with the surface of the skin-friendly inner layer to ensure stable and uniform optical contact with the skin under inflated restraint, while the breathable structure of the skin-friendly inner layer does not affect the acquisition of optical signals.

[0015] A monitoring and control method for an adaptive inflatable medical protective restraint system includes the following steps: The pneumatic control module initially inflates the airbag array of the restraint belt, causing the individual air chambers to expand and fit the limbs, thus establishing a preliminary restraint state and a stable optical measurement environment. The blood circulation sensing unit of the biofeedback module emits multi-wavelength light and receives light signals from the limbs, simultaneously collecting raw optical data. At the same time, the pressure sensing unit collects the interface pressure data of each independent air chamber. The system control module processes the raw optical data, calculates blood oxygen saturation values, pulse waveform characteristics, and characteristic parameters for blood pressure calculation in parallel from the same data source, and combines them with interface pressure data to form a comprehensive physiological dataset. The system control module compares the comprehensive physiological dataset with preset safety thresholds to determine whether blood oxygen saturation, blood pressure characteristics, and interface pressure are within safe ranges, and generates diagnostic results. When the diagnostic results are abnormal, the system control module generates precise pressure regulation commands, which drive the pneumatic control module to inflate or deflate specific independent air chambers, regulate local or overall pressure, and feed back the regulated pressure status to the diagnostic steps, forming a closed-loop control cycle with multiple parameters such as blood oxygen, blood pressure, and pressure as feedback.

[0016] Compared with the prior art, the present invention has the following beneficial effects: This application, by setting up an array of airbags containing multiple independent air chambers and cooperating with a pneumatic control module to achieve dynamic inflation and deflation adjustment, completely changes the rigid pressure problem caused by the fixed size of traditional restraints, effectively reducing the incidence of pressure ulcers. At the same time, the flexible restraint method can significantly reduce patient resistance and reduce the risks in the nursing process compared with rigid restraint. The biofeedback module integrates a pressure sensing unit and a blood circulation sensing unit based on photoplethysmography, which not only monitors the interface pressure between the air chamber and the limb in real time, but also simultaneously calculates pulse waveform, blood oxygen saturation and blood pressure related characteristic parameters, solving the key pain point of traditional restraints being unable to monitor the limb circulation status, and can promptly warn of potential health problems such as abnormal blood circulation. The three-dimensional breathable mesh structure of the skin-friendly inner layer greatly improves breathability and significantly increases the rate of moisture diffusion, fundamentally improving the skin maceration and infection problem caused by the poor breathability of traditional restraints, and comprehensively ensuring the safety and comfort of patients.

[0017] The one-to-one correspondence between the multi-channel valve unit and the independent air chamber enables precise selective control of designated air chambers. Combined with dynamic pressure application and pulse wave signal analysis during blood pressure measurement, this makes physiological parameter monitoring more comprehensive and accurate. The mechanical automatic pressure relief design of the overpressure protection unit forms a redundant safety mechanism independent of the electronic control circuit. Even if the system malfunctions or the pressure exceeds the threshold, it can automatically release pressure, further strengthening the safety defense. The gradient pressure control strategy effectively prevents venous stasis through a pressure distribution that is higher at the distal end than the proximal end, and can be dynamically adjusted based on real-time physiological data to adapt to different limb states. The wireless communication unit enables remote transmission of physiological data to external monitoring terminals, and graded alarm signals are based on different... The system provides precise alerts and targeted pressure adjustment solutions, allowing nurses to intervene promptly and improve nursing efficiency. The automatic calibration unit ensures the long-term measurement accuracy of the sensor through zero-point calibration, sensitivity calibration, and optical signal reference calibration. The closed-loop control process achieves an automated cycle of monitoring, diagnosis, and adjustment, reducing the cost of manual intervention. Meanwhile, the sealed encapsulation of the blood circulation sensing unit and the flush design of the skin-friendly inner layer ensure both the stability of optical signal acquisition and wearing comfort. This makes the system suitable not only for core scenarios such as psychiatry and ICU, but also for extended scenarios such as rehabilitation and emergency departments, significantly improving the intelligence and precision of restraint care. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the overall structure of an adaptive inflatable medical protective restraint system according to the present invention.

[0019] Figure 2 This is a schematic diagram of the internal structure of an adaptive inflatable medical protective restraint system according to the present invention.

[0020] Figure 3This is a schematic diagram of the internal structure of an adaptive inflatable medical protective restraint system of the present invention after the partition is removed.

[0021] Figure 4 This is a partial structural schematic diagram of an adaptive inflatable medical protective restraint system according to the present invention.

[0022] Figure 5 This is a schematic diagram of the hand funnel cover structure of an adaptive inflatable medical protective restraint system according to the present invention.

[0023] Figure 6 This is a schematic diagram of the inside of the hand funnel cover of an adaptive inflatable medical protective restraint system of the present invention.

[0024] The components include: 1. restraint belt; 2. outer protective layer; 3. airbag bearing layer; 4. skin-friendly inner layer; 5. airbag array; 6. pressure sensing unit; 7. blood circulation sensing unit; 8. system control module; 9. common air inlet; 10. pressure regulating unit; 11. partition; 12. funnel-shaped cover; 13. hemispherical transparent cover; and 14. ventilation port. Detailed Implementation

[0025] The present invention will now be described in detail with reference to the accompanying drawings and embodiments. It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other.

[0026] The following detailed description is exemplary and intended to provide further detailed explanation of the invention. Unless otherwise specified, all technical terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. The terminology used in this invention is for the purpose of describing particular embodiments only and is not intended to limit the scope of exemplary embodiments according to the invention.

[0027] Example 1 like Figures 1-4 As shown, the adaptive inflatable medical protective restraint system in this embodiment is mainly used in medical scenarios such as psychiatry and ICU. It is used to restrain agitated patients or patients who need to restrict limb movement to ensure treatment safety, while taking into account safety, comfort and real-time monitoring functions.

[0028] The restraint strap 1 can be adjusted in length and width according to the limbs to be restrained (such as wrists, ankles, chests, waists, etc.) to ensure a proper fit to the contours of different limbs. Before use, the system requires a pre-inspection, including checking the connection status of each module, the air circuit seal, and the sensor responsiveness to ensure there are no loose parts, no air leaks, and that the sensors can collect data normally. This prevents initial abnormalities from affecting the restraint effect and patient safety. The restraint strap 1 uses a composite structure consisting of an outer protective layer 2, an airbag support layer 3, and a skin-friendly inner layer 4, layered sequentially from the outside in. Each layer is tightly bonded with medical-grade adhesive, and the bonding strength must be sufficient to prevent delamination under a certain tensile force, ensuring structural stability during long-term use.

[0029] The outer protective layer 2 is made of medical-grade polyurethane-coated nylon tape. This material has excellent tear resistance and can withstand the pulling force when the patient is agitated, preventing the restraint tape 1 from breaking and causing restraint failure. At the same time, the polyurethane coating has good waterproof and disinfection resistance. It can be wiped and disinfected with 75% ethanol solution or chlorine-containing disinfectant, and can be reused many times, reducing medical costs.

[0030] The airbag support layer 3 is the core functional layer of the restraint belt 1. The airbag array 5 inside it adopts a honeycomb arrangement structure, which is an improvement on existing airbag designs. Each independent air chamber is hexagonal, and adjacent air chambers are separated by medical-grade TPU separators 11, ensuring that each air chamber inflates and deflates independently without interference. Each independent air chamber has an air passage interface on its side wall for connecting to the fluid passage of the pneumatic control module. The interface adopts a barbed structure, which can achieve a sealed connection after insertion into the fluid passage, ensuring the stability of pressure regulation. The TPU material of the airbag support layer 3 has good elasticity and toughness, allowing for significant volume changes during inflation and deflation, and maintaining stable performance over a wide temperature range, adapting to the temperature requirements of different hospital environments.

[0031] The skin-friendly inner layer 4 is made of breathable mesh fabric with a three-dimensional structure. The size of the mesh pores ensures airflow while preventing skin tissue from getting stuck in the mesh and causing discomfort. The mesh fabric is woven using a warp-knitted three-dimensional structure, forming airflow channels and effectively reducing the accumulation of sweat on the skin surface, thus lowering the risk of skin maceration and infection. The skin-friendly inner layer 4 is bonded to the airbag support layer 3 using dot adhesive bonding, ensuring a strong connection without affecting the breathability of the mesh fabric or the inflation and deflation deformation of the airbag.

[0032] The pneumatic control module is integrated into one end of the constraint belt 1, with a compact overall structure, preventing the constraint belt 1 from tilting due to module-specific factors, which would affect the fit. The module mainly consists of a multi-way air valve unit, a pressure regulation unit 10, and an overpressure protection unit. Each unit is connected to the electrical circuitry through internal air passages, forming a compact integrated structure.

[0033] The multi-way valve unit employs a miniature solenoid valve array, featuring a common air port 9 and multiple independent control air ports. The number of independent control air ports corresponds to the number of independent air chambers in the airbag array 5, and can be adjusted according to the size of the restraint band 1 (smaller restraint band 1 corresponds to fewer independent control air ports, and larger ones to more). Each independent control air port is connected to its corresponding independent air chamber via a fluid passage made of medical-grade silicone. The silicone material has good flexibility and can change with the bending and deformation of the restraint band 1 without affecting the airflow. The solenoid valves of the multi-way valve unit respond rapidly, and their on / off state is controlled by the system control module 8 via level signals. When a "inflate" command is received, the solenoid valve opens, connecting the common air port 9 to the corresponding independent control air port for gas injection; when a "de-inflate" command is received, the solenoid valve switches its state, connecting the independent control air port to the atmosphere for gas release.

[0034] The pressure regulating unit 10 connects to the common air port 9 of the multi-way air valve unit, providing two pressure regulation methods: manual and electric. Manual regulation is achieved through a syringe interface located on the pneumatic control module housing. The interface conforms to the standard Luer interface of medical syringes, allowing direct connection to a medical syringe. Gas injection and discharge are achieved through the pushing and pulling of the syringe. This parameter is calibrated based on the volume of the air bladder and the capacity of the syringe, ensuring pressure control accuracy during manual regulation. Electric regulation is achieved through an optional miniature air pump. The miniature air pump automatically outputs gas at a set pressure according to the instructions of the system control module 8, suitable for scenarios requiring frequent pressure adjustments or high pressure accuracy (such as patients in the ICU requiring strict control of restraint pressure). The pressure regulating unit 10 also includes a pressure detection subunit, which monitors the pressure value of the common air port 9 in real time through a miniature pressure sensor and transmits the data to the system control module 8 as feedback for pressure regulation.

[0035] The overpressure protection unit employs a mechanical spring-loaded pressure relief valve structure. It automatically releases pressure when the pneumatic control module malfunctions (e.g., a stuck solenoid valve prevents air release) or when the system pressure exceeds a first safety threshold. This first safety threshold is determined based on clinical nursing data (exceeding this value can easily lead to limb vascular compression and occlusion). The overpressure protection unit is integrated into the restraint strap 1, specifically located at the edge of the airbag support layer 3. Each overpressure protection unit is directly connected to at least one independent air chamber via a short fluid passage. For independent air chambers corresponding to critical limb areas (such as the inner wrist and inner ankle), each chamber has its own dedicated overpressure protection unit, ensuring rapid pressure release under high pressure. This mechanical structure requires no electrical drive and can operate normally even during system power outages, providing dual safety protection.

[0036] The biofeedback module is integrated between the airbag support layer 3 and the skin-friendly inner layer 4 of the restraint strap 1, avoiding direct contact with the patient's skin to prevent sensor wear or skin irritation, while ensuring accurate acquisition of parameters at the air chamber-limb interface. This module mainly includes a pressure sensing unit 6 and a blood circulation sensing unit 7. Each independent air chamber corresponds to at least one pressure sensing unit 6, while the blood circulation sensing units 7 are set according to the physiological characteristics of the restraint site (e.g., two units are set for wrist restraint, located on either side of the wrist crease; two units are set for ankle restraint, located near the medial and lateral malleoli respectively), ensuring monitoring of blood circulation in key areas.

[0037] The pressure sensing unit 6 employs a ring-shaped pressure-sensing foil made of flexible polyimide, which can bend with the inflation and deflation of the airbag without affecting its volume changes. The size of the ring-shaped pressure-sensing foil matches the inner diameter of the independent air chamber and is attached to the airbag support layer 3, connected to the signal circuit of the biofeedback module via conductive adhesive. The working principle of the pressure-sensing foil is based on the piezoresistive effect. When the air chamber is inflated, the sensing foil is subjected to the combined action of the air chamber pressure and the limb's reaction force, causing its resistance value to change with the pressure. By measuring the change in resistance value, the interface pressure value can be calculated, reflecting the dynamic changes in pressure in real time. To avoid pressure interference from adjacent air chambers, the signal circuit of the pressure-sensing foil uses a shielded design with a copper mesh shielding layer, reducing electromagnetic interference and ensuring data stability.

[0038] The blood circulation sensing unit 7 is a fiber optic pulse sensor based on photoplethysmography (PPG), consisting of a transmitter and a receiver symmetrically positioned on the airbag support layer 3. This ensures that the light signal emitted by the transmitter effectively illuminates the limb skin and is collected by the receiver. The transmitter uses a dual-wavelength light-emitting diode (LED) that emits red and infrared light. Red light is primarily used to monitor blood flow in the superficial layers of the skin, while infrared light is used to monitor blood flow in the deeper layers. The combination of these two wavelengths improves the accuracy of blood circulation assessment. The receiver uses a photodiode to convert the received light signal into an electrical signal. After amplification and filtering, the electrical signal is transmitted to the system control module 8. The blood circulation sensing unit 7 can acquire complete pulse wave signals. By analyzing the peak value, trough value, period, and amplitude changes of the pulse wave, the blood circulation status of the limb can be determined (for example, a significant decrease in amplitude or a significant increase in period indicates potential blood circulation obstruction). When inflated, the pressure of the air bladder causes the sensor to fit tightly against the skin, reducing the attenuation of the light signal by air, improving the signal-to-noise ratio of the signal acquisition, and ensuring a stable pulse signal even when the patient is slightly active.

[0039] The biofeedback module offers both wired and wireless data transmission. Wired transmission connects to the system control module 8 via a flexible cable, suitable for scenarios with high module integration. Wireless transmission utilizes a built-in wireless communication unit employing Bluetooth Low Energy (BLE) technology, compliant with relevant protocol standards. Its transmission distance meets the needs of hospital wards (the distance between the nurses' station and the bed is typically within a normal range). The wireless communication unit transmits data including real-time pressure values ​​from the pressure sensing unit 6, raw pulse wave data from the blood circulation sensing unit 7, and processed parameters such as pulse rate and amplitude. This real-time transmission is achieved with low power consumption, allowing for extended continuous operation on a single charge.

[0040] System control module 8 is the core control unit of this system. It uses a microcontroller as the main control chip, which features low power consumption and high performance, making it suitable for medical device applications. The chip integrates an analog-to-digital converter (ADC) module, a serial communication (UART) module, and a pulse width modulation (PWM) module, enabling data acquisition, command generation, and module communication functions. The housing of system control module 8 is made of medical-grade ABS plastic, allowing it to be fixed to the outside of the restraint strap 1 or worn separately on the patient's clothing for convenient operation and observation.

[0041] The core function of system control module 8 is adaptive pressure regulation, and its working logic is as follows: First, after the system is powered on and initialized, the automatic calibration unit calibrates the biofeedback module and the pneumatic control module (the calibration process is detailed below); after calibration, the system enters standby mode, and the nursing staff sets the target constraint pressure range (based on clinical nursing standards) according to the patient's limb size and constraint needs through the buttons on the module or an external monitoring terminal; then, system control module 8 sends an "initial inflation" command to the pneumatic control module, controlling the pressure regulation unit 10 to inflate each independent air chamber through the multi-way air valve unit. During inflation, the biofeedback module collects the pressure data of each air chamber in real time and transmits it to system control module 8. When the pressure of all air chambers reaches the lower limit of the target range, the initial inflation is completed.

[0042] During the constraint maintenance phase, the biofeedback module continuously collects pressure and blood circulation data, and the system control module 8 performs real-time analysis of the data: if the pressure value of an independent air chamber exceeds the upper limit of the target range, the system immediately generates a "local venting" command, controls the solenoid valve corresponding to that air chamber to open, and releases gas until the pressure drops to the target range; if the blood circulation parameters of a certain area are abnormal (such as a significant decrease in pulse amplitude or a pulse rate change exceeding the normal range), the system first determines whether it is caused by excessive pressure. If blood circulation abnormalities still occur within the target pressure range, a "regional pressure relief" command is generated to reduce the pressure of all independent air chambers in that area, while recording the abnormal data; if excessive pressure causes blood circulation abnormalities, "local venting" is first executed until the pressure is normal, and then the blood circulation parameters are observed to see if they recover. If they do not recover, the pressure is further reduced.

[0043] The system control module 8 also features gradient pressure control, which is executed during both the initial inflation phase and the restraint maintenance phase. During initial inflation, the system first inflates the independent air chambers in the distal limb region (such as the end of the wrist away from the heart and the end of the ankle away from the heart) to bring the pressure to the middle value of the target range. Then, it inflates the independent air chambers in the proximal limb region (such as the end of the wrist near the heart and the end of the ankle near the heart) to bring the pressure to the lower limit of the target range. During the maintenance phase, the system ensures that the pressure in the distal air chambers is always higher than that in the proximal air chambers by adjusting in real time. This gradient pressure design can promote venous return in the distal limb, reduce blood pooling in the distal limb, and reduce the risk of venous thrombosis, which is especially suitable for patients who require long-term restraint.

[0044] When the blood circulation sensing unit 7 detects a severe blood circulation abnormality (such as the disappearance of the pulse signal or a significant drop in amplitude), the system control module 8 immediately triggers an emergency response mechanism: on the one hand, it generates an "alarm signal" and sends it to the external monitoring terminal via the wireless communication unit. The terminal issues an audible and visual alarm and displays the abnormal location and data; on the other hand, it generates an "emergency pressure relief" command, controlling the pneumatic control module to open the solenoid valves of all independent air chambers, performing global pressure relief to ensure rapid relief of excessive pressure and prevent limb ischemia and necrosis. After emergency treatment, the system continues to monitor blood circulation parameters until they return to normal. If the parameters do not return to normal after a prolonged period, the system will send an alarm signal again to remind nursing staff to intervene manually.

[0045] The automatic calibration unit is integrated with the system control module 8. Through the combination of software algorithms and hardware circuits, it realizes automatic calibration of the zero drift of the biofeedback module and the pressure reference of the pneumatic control module, ensuring the measurement and adjustment accuracy of the system during long-term use and avoiding errors caused by factors such as component aging and temperature changes.

[0046] The calibration process starts automatically each time the system is powered on. First, the zero-point drift calibration of the biofeedback module is performed: the system control module 8 controls the pneumatic control module to open the solenoid valves of all independent air chambers, completely releasing the gas in the air chambers and making the air chamber pressure consistent with atmospheric pressure (at this time, the interface pressure is 0); then, the system control module 8 sends a "zero-point acquisition" command to the biofeedback module to acquire the current output value of each pressure sensing unit 6 (this value is the zero-point drift value, which may be generated due to factors such as sensor aging and temperature changes); the system stores the acquired zero-point drift value in the internal memory. During subsequent pressure measurements, the corresponding zero-point drift value is subtracted from the real-time acquired pressure value to obtain the actual interface pressure value, ensuring measurement accuracy.

[0047] Next, the pressure reference calibration of the pneumatic control module is performed: the system control module 8 controls the pressure regulating unit 10 of the pneumatic control module to output a standard pressure value (this value is the middle value of the target constraint pressure range), and injects gas into a designated independent air chamber through the multi-way air valve unit (usually the air chamber in the middle of the constraint band 1 is selected, as this air chamber is less affected by edge effects); after the air chamber pressure stabilizes, the system control module 8 reads the actual measurement value of the pressure sensing unit 6 corresponding to that air chamber in the biofeedback module; if there is a deviation between the actual measurement value and the standard pressure value, the system control module 8 sends a "reference correction" command to the pressure regulating unit 10 to adjust the output parameters of the pressure regulating unit 10 (such as the working time of the electric air pump, the pressure coefficient during manual adjustment) until the deviation between the actual measurement value and the standard pressure value is within the allowable range; after calibration, the system stores the corrected parameters, and subsequent pressure adjustments are based on the corrected parameters to ensure adjustment accuracy.

[0048] To further ensure accuracy, the automatic calibration unit also has a periodic calibration function. Nurses can set the calibration cycle through an external monitoring terminal. When the system has been working continuously for a period of time, if the patient's condition is stable (no strenuous activity, restraint band 1 has not shifted), the system will automatically prompt for periodic calibration. The calibration process is the same as during power-on initialization. If the patient's condition is unstable, the system will delay calibration until the patient's condition is stable before proceeding, so as to avoid the calibration process affecting the restraint effect.

[0049] The wireless communication unit is integrated into the biofeedback module or system control module 8. It adopts BLE technology, supports multi-device connection, and can establish communication connection with one system control module 8 and two external monitoring terminals (such as the computer at the nurse station and the mobile tablet of the nursing staff) at the same time, ensuring that data can be transmitted to different terminals in real time, so that the nursing staff can monitor at any time.

[0050] The data transmitted by the wireless communication unit is divided into two categories: one is real-time monitoring data, including the pressure value of each independent air chamber, blood circulation parameters (pulse rate, pulse amplitude), system status (inflation / de-inflation status, solenoid valve on / off status, battery power); the other is historical data, including records of abnormal pressure, abnormal blood circulation, calibration records, etc. Historical data is stored by timestamp, which makes it convenient for nursing staff to trace the patient's restraint process and the system's working status.

[0051] The external monitoring terminal requires the installation of matching monitoring software. The software interface is divided into a data display area, a status prompt area, and an operation area. The data display area shows each monitoring parameter in real time in the form of curves or numbers (such as a pressure curve with time on the horizontal axis and pressure value on the vertical axis, which intuitively shows the pressure change trend of each air chamber). The status prompt area uses different colors to indicate the system status (green indicates normal, yellow indicates that the pressure is close to the threshold, and red indicates an abnormal alarm). The operation area provides functions such as parameter setting, calibration triggering, and manual control. Nursing staff can modify the target pressure range, set the calibration cycle, or manually control the pneumatic control module to perform pressure relief operations in an emergency through the operation area.

[0052] When the system control module 8 generates an alarm signal, the wireless communication unit will transmit the alarm signal to the external monitoring terminal with the highest priority. The terminal will immediately issue an audible and visual alarm, and at the same time, an alarm window will pop up on the interface, displaying the alarm type (such as overpressure alarm, blood circulation abnormality alarm, emergency pressure relief alarm), alarm location, and current parameter values. Nursing staff can directly send an "acknowledge alarm" command through the alarm window. After receiving the command, the system will stop the audible and visual alarm, but will continue to monitor parameter changes until the abnormality is resolved. If the nursing staff does not acknowledge the alarm for a long time, the terminal will automatically upgrade the alarm level, increase the alarm volume, and send alarm signals to more monitoring terminals to ensure that the alarm can be handled in a timely manner.

[0053] The external monitoring terminal also has a data export function, allowing nursing staff to export historical data to common formats (such as Excel or PDF) for use in patient care records, medical quality assessments, or system performance analysis. The exported data includes complete timestamps and parameter values, ensuring data traceability and authenticity, and meeting the hospital's medical record management requirements.

[0054] As a preferred example, when the restraint strap 1 is used to fix the patient's wrist, a funnel-shaped cover 12 can also be connected to one side of the restraint strap 1. The funnel-shaped cover 12 has a smaller diameter at one end and a larger diameter at the other end. When in use, the patient's hand is located inside the funnel-shaped cover 12. Multiple honeycomb-shaped airbag arrays 5 are provided inside the funnel-shaped cover 12 to apply pressure to the patient's hand. A pneumatic control module, a biofeedback module, and a system control module 8 connected to the airbag arrays 5 are also provided. A hemispherical transparent cover 13 is provided at the larger diameter end of the funnel-shaped cover 12. A vent 14 is provided at the top of the hemispherical transparent cover 13. A gripping ball for the patient to grasp can also be provided inside the funnel-shaped cover 12.

[0055] Example 2 The monitoring and control method for the adaptive inflatable medical protective restraint system in this embodiment, based on the adaptive inflatable medical protective restraint system of Embodiment 1, specifically includes the following steps: Before using the system, check the connection status of each module, the air circuit sealing, and the sensor responsiveness to ensure there are no loose connections, no leaks, and that the sensors can collect data normally. After the check is completed, power on the system, and the automatic calibration unit immediately starts the calibration process. First, perform zero-point drift calibration on the biofeedback module (release the gas in the air chamber to atmospheric pressure, collect and store the zero-point drift value of the pressure sensing unit 6), and then perform pressure reference calibration on the pneumatic control module (output a standard pressure value to a designated independent air chamber, adjust the output parameters of the pressure regulating unit 10 to ensure that the deviation between the measured value and the standard value is within the allowable range). After calibration, the system enters standby mode. Nurses can set the target restraint pressure range (this range is determined based on clinical nursing standards) according to the patient's limb size and restraint requirements through the buttons on the system control module 8 or an external monitoring terminal.

[0056] The system control module 8 sends an "initial inflation" command to the pneumatic control module. The pressure regulation unit 10 of the pneumatic control module inflates the independent air chambers of the airbag array 5 through the multi-way valve unit. The inflation process follows a gradient pressure control strategy: first, the independent air chambers in the distal region of the limb are inflated until their pressure reaches the middle value of the target range, and then the independent air chambers in the proximal region of the limb are inflated until their pressure reaches the lower limit of the target range. During inflation, the pressure sensing unit 6 of the biofeedback module collects the interface pressure data of each independent air chamber in real time and transmits it to the system control module 8. When the pressure of all independent air chambers reaches the corresponding target value, the initial inflation is completed, the system establishes a preliminary constraint state, and the expansion of the airbags causes the blood circulation sensing unit 7 to fit tightly against the limb skin, forming a stable optical measurement environment.

[0057] After entering the restraint maintenance phase, the biofeedback module continues to operate: the dual-wavelength light emitter of the blood circulation sensing unit 7 emits light alternately, and the light receiver receives transmitted or reflected light signals from the limb, simultaneously acquiring raw optical data; the pressure sensing unit 6 acquires the interface pressure data between each independent air chamber and the limb in real time. The acquired raw optical data and pressure data are transmitted to the system control module 8 via wired or wireless means. The system control module 8 amplifies and filters the raw optical data, and calculates blood oxygen saturation values, pulse waveform characteristics (such as peak value, trough value, and period) and characteristic parameters used to calculate blood pressure (such as pulse wave propagation time and amplitude change rate) in parallel from the same data source. It then integrates these physiological parameters with the interface pressure data to form a comprehensive physiological dataset.

[0058] The system control module 8 compares the comprehensive physiological dataset with preset safety thresholds (including safe pressure range, blood oxygen saturation threshold, and blood pressure parameter threshold) in real time to determine whether each parameter is within the safe range: if the interface pressure data is within the safe pressure range, the blood oxygen saturation value is not lower than the threshold, and the blood pressure parameters (such as systolic and diastolic blood pressure reference values) are in the normal range, a "normal" diagnostic result is generated, and the system continues to maintain the current constraint state; if the interface pressure exceeds the upper limit of the safe range, or the blood oxygen saturation is lower than the threshold, or the blood pressure parameter is outside the normal range, an "abnormal" diagnostic result is generated, and the specific value, occurrence time, and corresponding location of the abnormal parameter are recorded.

[0059] When the diagnosis result is "abnormal," the system control module 8 generates precise pressure regulation commands based on the type of abnormality, driving the pneumatic control module to perform corresponding operations: if only a single independent air chamber has excessively high pressure, the corresponding solenoid valve of that air chamber is opened to perform local deflation until the pressure drops to a safe range; if the blood circulation parameters in a certain area are abnormal (such as a continuous decrease in blood oxygen saturation) and are determined to be related to pressure, the pneumatic control module is instructed to reduce the pressure of all independent air chambers in that area; if blood pressure parameters indicate insufficient perfusion in the extremities, the gradient pressure distribution is adjusted to reduce the pressure difference between distal and proximal independent air chambers. After pressure regulation is completed, the biofeedback module collects interface pressure and blood circulation data again and transmits them to the system control module 8 for a new round of processing and diagnosis. If the diagnosis result returns to normal, the system maintains the current pressure state; if it is still abnormal, the pressure regulation steps are repeated until the parameters return to a safe range, forming a closed-loop control cycle with multiple parameters such as blood oxygen, blood pressure, and pressure as feedback.

[0060] Throughout the monitoring and control process, if the system control module 8 detects a serious abnormality (such as loss of pulse signal, significant drop in blood oxygen saturation, or pressure far exceeding the safety threshold), it immediately triggers an alarm mechanism: a tiered alarm signal (divided into different warning levels according to the severity of the abnormality) is sent to the external monitoring terminal via the wireless communication unit. The terminal then issues an audible and visual alarm and displays the abnormal information. Simultaneously, the system control module 8 generates an "emergency pressure relief" command, controlling the pneumatic control module to open the solenoid valves of all independent air chambers, performing global pressure relief to quickly relieve excessive pressure. After emergency treatment, the system continues to monitor physiological parameters. If the parameters do not return to normal for an extended period, an alarm signal is sent again to alert nursing staff for manual intervention.

[0061] During operation, the system records various monitoring data (including real-time pressure values, blood oxygen saturation, blood pressure parameters, and pulse waveform data) and operation records (such as inflation / deflation commands, calibration operations, and alarm handling) in real time according to timestamps, forming historical data and storing it. Nursing staff can view historical data through an external monitoring terminal, and can also export the data to a standard format for patient care record archiving, medical quality assessment, or system performance analysis, ensuring the traceability of the entire restraint process.

[0062] Through the above steps, safe restraint and real-time physiological monitoring of the patient's limbs can be achieved, ensuring the restraint effect while timely detection and handling of potential health risks, thereby improving the safety and intelligence level of medical care.

[0063] As is known from common technical knowledge, this invention can be implemented through other embodiments that do not depart from its spirit or essential characteristics. Therefore, the disclosed embodiments described above are merely illustrative in all respects and are not the only ones. All modifications within the scope of this invention or equivalent to the scope of this invention are included in this invention.

Claims

1. An adaptive inflatable medical containment restraint system, comprising: The application relates to a safety restraint system, comprising: a restraint belt body (1) internally provided with an airbag array (5) comprising a plurality of independent air chambers; a pneumatic control module in fluid connection with the airbag array (5) for inflating and deflating the independent air chambers; a biofeedback module integrated in the restraint belt body (1) and used for contacting a limb, which comprises a pressure sensing unit (6) for monitoring the interface pressure of the independent air chambers and a blood supply sensing unit (7) for monitoring the blood supply state of the limb; and a system control module (8) in signal connection with the pneumatic control module and the biofeedback module respectively; wherein the blood supply sensing unit (7) is a multi-parameter sensor based on photoplethysmography, which comprises at least two light emitters of different wavelengths and corresponding light receivers, the light emitters and the light receivers being arranged on the inner side of the airbag array (5) and used for adhering to the skin of the limb in the inflated state; the system control module (8) is configured to perform the following operations: receiving the interface pressure data from the pressure sensing unit (6) and receiving the original light signal obtained by collecting the photoplethysmogram signal from the blood supply sensing unit (7); processing and analyzing the original light signal to synchronously calculate the pulse waveform data, the blood oxygen saturation data and the characteristic parameters for calculating the blood pressure of the limb; based on the preset safe pressure range, the blood oxygen saturation threshold and the blood pressure parameter threshold, a control instruction is generated to drive the pneumatic control module to adaptively adjust the pressure of the specified independent air chamber.

2. An adaptive inflatable medical containment restraint system according to claim 1, wherein, the pneumatic control module comprises: a multi-way air valve unit having one common air port (9) and a plurality of independent control air ports, the plurality of independent control air ports being connected with the independent air chambers in the airbag array (5) one by one through fluid passages; a pressure regulating unit (10) connected with the common air port (9) for providing positive pressure or negative pressure; wherein the system control module (8) realizes the selective inflation or deflation of the specified independent air chamber by controlling the on-off of each valve in the multi-way air valve unit; and when the blood pressure is calculated by using the blood supply sensing unit (7), the system control module (8) coordinately controls the pressure regulating unit (10) and the multi-way air valve unit to apply a changing pressure to the target independent air chamber, simultaneously records the corresponding pulse wave signal change trend, and determines the reference values of the systolic pressure and the diastolic pressure by analyzing the relationship between the pulse wave amplitude and the airbag pressure.

3. An adaptive inflatable medical containment restraint system according to claim 2, wherein, the pneumatic control module further comprises an overpressure protection unit, the overpressure protection unit is used for executing mechanical automatic pressure relief when the pneumatic control module fails or the system pressure exceeds a first safety threshold; the overpressure protection unit is integrated on the restraint belt body (1) and directly communicates with at least one independent air chamber, the pressure relief action of the overpressure protection unit is independent of the electric control circuit of the system control module (8), and a redundant safety mechanism is provided.

4. An adaptive inflatable medical containment restraint system according to claim 1, wherein, The system control module (8) calculates the blood oxygen saturation by controlling the light emitters of the blood supply sensing unit (7) to emit light of two different wavelengths alternately, receiving the corresponding transmitted or reflected light signals, calculating the AC-to-DC component ratio of the light signals of the two wavelengths, and obtaining the blood oxygen saturation value based on a pre-calibrated blood oxygen saturation curve. The blood oxygen saturation value and the pulse waveform data are derived from the synchronous processing of the same set of optical signals.

5. An adaptive inflatable medical containment restraint system according to claim 1, wherein, The system control module (8) is further configured to perform gradient pressure control. In the initial inflation or pressure maintenance stage, the pneumatic control module is controlled to make the internal pressure of the independent air chamber located in the distal region of the limb higher than that of the independent air chamber located in the proximal region of the limb. The gradient pressure control strategy is associated with real-time monitored blood pressure data and blood oxygen saturation data. When the blood oxygen saturation is below a threshold value or the blood pressure parameter is abnormal, the system control module (8) dynamically adjusts the distribution or overall level of the gradient pressure.

6. An adaptive inflatable medical containment restraint system according to claim 1, wherein, The biological feedback module and the system control module (8) communicate data through a wireless communication unit. The wireless communication unit further packages and transmits the blood oxygen saturation data, blood pressure parameters, pulse waveform data, and interface pressure data to an external monitoring terminal. The system control module (8) is further configured to generate a hierarchical alarm signal when the blood oxygen saturation data or blood pressure parameters exceed a safe range, and send the signal to the external monitoring terminal through the wireless communication unit, while driving the pneumatic control module to perform targeted pressure adjustment.

7. An adaptive inflatable medical containment restraint system according to claim 6, wherein, The targeted pressure adjustment performed by the system control module (8) includes at least one of the following: when the blood oxygen saturation continues to decrease, instructing the pneumatic control module to reduce the pressure of all independent air chambers; when the blood pressure parameter shows that the limb ends are insufficiently perfused, instructing the pneumatic control module to adjust the gradient pressure distribution to reduce the pressure difference between the distal and proximal ends; and the hierarchical alarm signal is divided into different warning levels according to the magnitude of the decrease in blood oxygen saturation or the duration of blood pressure abnormalities.

8. An adaptive inflatable medical containment restraint system according to claim 1, wherein, The system further comprises an automatic calibration unit connected to the system control module (8). The automatic calibration unit is configured to perform a calibration process for the biological feedback module during system power-on initialization or periodic self-checking. The calibration process includes: calibrating the zero point of the pressure sensing unit (6) in the no-load state; controlling the pneumatic control module to generate a series of known reference pressures in a specific independent air chamber to calibrate the sensitivity of the pressure sensing unit (6); and calibrating the optical signal reference of the blood supply sensing unit (7) under standard test conditions to ensure the accuracy of blood oxygen saturation and blood pressure characteristic parameter calculation.

9. An adaptive inflatable medical containment restraint system according to claim 1, wherein, The restraint belt body (1) comprises, from outside to inside, an outer protective layer (2), an airbag bearing layer (3) and a skin-friendly inner layer (4) arranged in sequence; the airbag bearing layer (3) is provided with the airbag array (5), and the skin-friendly inner layer (4) is a breathable mesh cloth with a three-dimensional structure; the light emitter and the light receiver of the blood supply sensing unit (7) are sealed and embedded in the skin-friendly inner layer (4), and the optical window is flush with the surface of the skin-friendly inner layer (4), so that stable and uniform optical contact with the skin is ensured in the inflated restraint state, and the breathable structure of the skin-friendly inner layer (4) does not affect the collection of optical signals.

10. A method of monitoring and controlling an adaptive inflatable medical containment restraint system according to any one of claims 1-9, wherein, The method comprises the following steps: The airbag array (5) of the restraint belt body (1) is initially inflated by the pneumatic control module, so that the independent air chambers are expanded and attached to the limbs, a preliminary restraint state and a stable optical measurement environment are established; The blood supply sensing unit (7) of the biofeedback module emits multi-wavelength light and receives optical signals from the limbs, synchronously collects original optical data, and simultaneously collects interface pressure data of each independent air chamber by the pressure sensing unit (6); The system control module (8) processes the original optical data, calculates the blood oxygen saturation value, the pulse waveform feature and the feature parameter for blood pressure calculation from the same data source in parallel, and forms a comprehensive physiological data set in combination with the interface pressure data; The system control module (8) compares the comprehensive physiological data set with the preset safety threshold, judges whether the blood oxygen saturation, blood pressure feature and interface pressure are within the safety range, and generates a diagnosis result; When the diagnosis result is abnormal, the system control module (8) generates accurate pressure adjustment instructions to drive the pneumatic control module to inflate or deflate specific independent air chambers, adjust the local or overall pressure, and feed back the adjusted pressure state to the diagnosis step, forming a closed-loop control cycle with blood oxygen, blood pressure and pressure multi-parameters as feedback.

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