Multi-modal sensing fusion orthosis and monitoring method

Abstract

The invention discloses a multi-mode sensing fusion orthosis and a monitoring method. The orthosis comprises an orthosis brace, a flexible sensing unit, a signal processing unit and a data terminal. The shape of the orthosis brace is matched with the spine of a user, and the tightness degree of the orthosis brace is adjustable; the flexible sensing unit is installed in a pressure application area on the inner side of the orthosis brace and used for detecting state data of the pressure application area and sending the state data to the signal processing unit. The signal processing unit is installed on the outer side of the orthosis brace and used for conducting analog-to-digital conversion on the state data and uploading the state data to the data terminal. And the data terminal is in communication connection with the signal processing unit and is used for outputting indication information according to a comparison result of the state data and a preset state threshold value so as to remind a user to adjust the tightness degree of the orthosis brace. Through the arrangement of the flexible sensing unit, the signal processing unit and the data terminal, pressure injury early warning in the user correction process can be achieved, and the safety and effectiveness of the treatment process are effectively guaranteed.

Description

Technical Field

[0001] The present invention relates to the technical field of scoliosis orthoses, and in particular to a multi-modal sensing fusion orthosis and a monitoring method. Background Art

[0002] Adolescent idiopathic scoliosis (AIS) is a type of spinal lesion in which the spine deviates from the midline of the body and bends laterally with an angle greater than 10°. AIS not only affects the patient's trunk nerves, muscles, and ligaments, but can also cause radiating pain, chest asymmetry, and affect cardiopulmonary function in severe cases. Currently, surgical treatment is used for AIS patients with severe spinal deformity with a Cobb angle >45°. However, due to the difficulty of the operation, nerve damage during the operation, and many postoperative complications, conservative treatment is preferred for AIS patients with a Cobb angle of 20-45° or patients with a scoliosis of less than 25° but with a record of scoliosis progression of 5-10° within 6 months.

[0003] The most commonly used conservative treatment is orthosis treatment, whose mechanism of action is to use the multiple groups of "three-point forces" constructed by the pressure pad of the orthosis to apply pressure to the protruding parts of the bones, prompting the soft tissue to move to the release space, thereby changing the biomechanical properties of the spinal structure and rebuilding the spinal structure. Scoliosis orthoses use physical correction methods. By wearing them for a long time, patients can significantly prevent the further development of the angle and restore the bending angle.

[0004] However, since the orthotic intervention process relies heavily on the personal experience of physicians or orthologists, the safety and effectiveness of the AIS orthotic process cannot be effectively supervised and implemented. Excessive orthotic pressure not only affects wearing compliance, but also aggravates pressure damage and affects respiratory function over a long period of time; excessively low orthotic pressure cannot effectively achieve spinal correction. In addition, pressure damage to the skin or subcutaneous tissue caused by long-term pressure on bony protrusions will not only significantly reduce the patient's health-related quality of life, but also affect the normal wearing of the brace, leading to safety hazards during the orthotic process. Summary of the invention

[0005] The present invention provides a multi-modal sensing fusion orthosis and a monitoring method, which solves the technical problem that the existing orthosis cannot monitor multiple parameters and adjust the tightness of the orthosis in real time during the orthosis process, resulting in the inability to ensure the safety and effectiveness of brace wearing and prone to potential safety hazards.

[0006] The present invention provides a multi-modal sensing fusion orthosis, comprising an orthosis brace, a flexible sensing unit, a signal processing unit and a data terminal;

[0007] The orthotic brace is an integrally formed structure whose shape is adapted to the user's spine and whose tightness can be adjusted;

[0008] The flexible sensing unit is installed at the pressure application area inside the orthosis brace, and is used to detect the state data of the pressure application area and send it to the signal processing unit;

[0009] The signal processing unit is installed on the outside of the orthotic brace, and is used to perform analog-to-digital conversion on the status data and upload it to the data terminal;

[0010] The data terminal is in communication with the signal processing unit and is used to output instruction information according to the comparison result between the state data and the preset state threshold value, so as to remind the user to adjust the tightness of the orthotic brace.

[0011] Optionally, a pressure adjustment assembly is also included;

[0012] The orthotic brace is also provided with a plurality of pressure release holes;

[0013] The pressure adjustment component is movably connected to the movable end of the orthotic brace and is used to gradually adjust the tightness of the orthotic brace to adjust the pressure of the pressure area.

[0014] Optionally, the orthotic brace is provided with a through hole, and the flexible sensing unit is connected to the signal processing unit via the through hole;

[0015] The flexible sensing unit includes multiple groups of pressure sensing units and multiple groups of temperature sensing units, and the state data includes pressure voltage data and temperature voltage data;

[0016] The pressure sensing unit and the temperature sensing unit are attached to the inner surface of each of the pressure application areas in pairs, and are used to detect pressure voltage data and temperature voltage data of each of the pressure application areas.

[0017] Optionally, the sensing area of ​​the pressure sensing unit is 1×1 cm 2 , the thickness of the pressure sensing unit is 0.5mm~1mm;

[0018] The sensing area of ​​the temperature sensing unit is 2×2.3 mm 2 , the thickness of the temperature sensing unit is 0.8mm~1.2mm.

[0019] Optionally, the pressure sensing unit comprises a flexible sensing layer and a flexible electrode layer encapsulated by an encapsulation layer;

[0020] The flexible sensing layer is an array structure with one side in a micro-dome shape and in contact with the flexible electrode layer;

[0021] The material of the encapsulation layer is polyethylene terephthalate;

[0022] The surface of the flexible electrode layer has a conductive material coating.

[0023] Optionally, the flexible sensing layer is prepared by taking structured polydimethylsiloxane as a matrix and doping carbon nanotubes and silver particles inside.

[0024] Optionally, the preparation process of the flexible sensing layer includes:

[0025] Continuous ultrasound or pulsed ultrasound is used to disperse the outer diameter of 20nm~30nm and the length of 0.5 ~2 and stirring for 30 min to obtain a carbon nanotube dispersion;

[0026] After adding n-hexane to the polydimethylsiloxane liquid and stirring for 15 minutes, add The silver powder is dispersed by ultrasonic stirring to obtain a silver particle dispersion;

[0027] Add the carbon nanotube dispersion to the silver particle dispersion, mix and stir for 14 to 18 hours, then add a curing agent and stir at room temperature for 1 hour to obtain a carbon nanotube-silver powder two-phase dispersion;

[0028] The pretreated aluminum substrate is baked at 65° C. and 95° C. respectively, and a photoresist is spin-coated;

[0029] The aluminum substrate after spin coating with photoresist was covered with a micro-dome-shaped mask and exposed to ultraviolet light for 18s-21s, and post-baked at 65°C and 95°C respectively;

[0030] After post-baking, the aluminum substrate is added with developer and hardened at 150°C for 30 minutes. After cooling to room temperature, it is anodized in oxalic acid solution for 19 hours to 24 hours.

[0031] The aluminum substrate after anodization is acid-etched by using a mixed solution of chromic acid and phosphate to obtain an aluminum-based template with a micro-dome-shaped mask structure;

[0032] The carbon nanotube-silver powder dual-phase dispersion was poured into the fluorinated aluminum-based template, cured at 70° C. for 12 h, and demolded to obtain a flexible sensing layer.

[0033] Optionally, the signal processing unit includes a main control module and a connector, a power management module, a pressure conversion circuit and a temperature conversion circuit respectively connected to the main control module;

[0034] The power management module is used to supply power to the main control module, the pressure conversion circuit and the temperature conversion circuit;

[0035] The pressure conversion circuit is connected to the flexible sensing unit through the connector;

[0036] The temperature conversion circuit comprises a Wheatstone bridge circuit and a staged amplifier circuit connected in sequence;

[0037] The Wheatstone bridge circuit is connected to the flexible sensing unit through the connector, and the hierarchical amplification circuit is connected to the main control module;

[0038] The main control module is used to perform analog-to-digital conversion on the status data and upload the converted data to the data terminal.

[0039] Optionally, the data terminal is specifically used for:

[0040] When the pressure voltage data and the temperature voltage data are received, converting the temperature voltage data to obtain temperature data;

[0041] Converting the pressure voltage data to obtain pressure data;

[0042] After the pressure voltage data cache is filled to the buffer array, the buffer array is subjected to frequency domain analysis, the main component of the signal frequency is selected as the respiratory rate data and the buffer array is cleared;

[0043] The respiratory rate data, the temperature data and the pressure data are compared with preset state thresholds respectively, and prompt information is generated according to the comparison results.

[0044] The present invention also provides a multi-modal sensing fusion orthosis monitoring method, which is applied to the multi-modal sensing fusion orthosis as described in any one of the above, and the method comprises:

[0045] When the orthotic brace is worn by the user, the data terminal sends a monitoring start instruction to the signal processing unit to start the flexible sensing unit;

[0046] Acquiring state data of each pressure application area in the orthosis brace through the flexible sensing unit according to a preset period, and transmitting the data to the signal processing unit;

[0047] Performing analog-to-digital conversion on the status data through the signal processing unit, and uploading the converted data to the data terminal;

[0048] The data terminal outputs instruction information according to the comparison result between the state data and the preset state threshold value to remind the user to adjust the tightness of the orthotic brace.

[0049] It can be seen from the above technical solutions that the present invention has the following advantages:

[0050] The present invention provides a multi-modal sensing fusion orthosis and monitoring method, wherein the orthosis includes an orthosis brace, a flexible sensing unit, a signal processing unit and a data terminal; the orthosis brace is an integrally formed structure whose shape is adapted to the user's spine and whose tightness is adjustable; the flexible sensing unit is installed in the pressure area inside the orthosis brace, and is used to detect the state data of the pressure area and send it to the signal processing unit; the signal processing unit is installed on the outside of the orthosis brace, and is used to perform analog-to-digital conversion on the state data and upload it to the data terminal; the data terminal is connected to the signal processing unit in communication, and is used to output indication information according to the comparison result between the state data and the preset state threshold value, so as to remind the user to adjust the tightness of the orthosis brace. Through the setting of the flexible sensing unit, the signal processing unit and the data terminal, it is possible to realize the early warning of pressure damage during the correction process of the user, and effectively ensure the safety and effectiveness of the treatment process. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0052] Figure 1 A schematic diagram of the structure of a multi-modal sensing fusion orthosis provided by an embodiment of the present invention;

[0053] Figure 2 A right view and a left view of a multimodal sensing fusion orthosis provided by an embodiment of the present invention;

[0054] Figure 3 A partial structural schematic diagram of a pressure sensor provided by an embodiment of the present invention;

[0055] Figure 4 A schematic diagram of a circuit structure of a signal processing unit provided in an embodiment of the present invention;

[0056] Figure 5 A flow chart of a process for generating indication information of a data terminal provided by an embodiment of the present invention;

[0057] Figure 6 A structural block diagram of a multi-modal sensing fusion orthosis provided by an embodiment of the present invention;

[0058] Figure 7 A flowchart of the steps of a multi-modal sensing fusion orthopedic monitoring method provided by an embodiment of the present invention.

[0059] Figure numerals: 1. orthosis brace; 2. flexible sensing unit; 21. pressure sensing unit; 22. temperature sensing unit; 211. flexible sensing layer; 212. flexible electrode layer; 3. signal processing unit; 31. button battery base; 32. external power supply test interface; 33. connector module; 34. main control module; 35. chip antenna; 36. program burning interface; 4. data terminal; 5. pressure adjustment component. DETAILED DESCRIPTION

[0060] Since the orthotic intervention process relies heavily on the personal experience of physicians or orthosis technicians, the safety and effectiveness of the AIS correction process cannot be effectively supervised and implemented. Excessive orthotic pressure not only affects wearing compliance, but also aggravates pressure damage and affects respiratory function under long-term action; too low orthotic pressure cannot effectively achieve spinal correction. In addition, pressure damage to the skin or subcutaneous tissue caused by long-term pressure on the bony protrusion will not only significantly reduce the patient's health-related quality of life, but also affect the normal wearing of the brace, so early prevention of these injuries is crucial. In addition, continuous monitoring of skin temperature can help prevent pressure damage, because tissue metabolism becomes more active at higher temperatures, and skin temperature provides a physiological indicator to prevent skin rupture. During breathing, the movement of the thorax creates a dynamic force couple system for anti-rotation, and each breathing cycle produces gentle movement in the direction of correction. Therefore, reasonable pressure setting without affecting the characteristics of respiratory rhythm and depth is the guarantee for achieving correction. Previous reports have suggested embedding single or multiple pressure sensors inside the brace to perform pressure mapping under posture changes, or using temperature sensors to monitor patient wearing time and compliance. However, these technologies cannot simultaneously track valuable ulcer-related information, including pressure, temperature, and respiration, at key locations susceptible to pressure injury.

[0061] To this end, an embodiment of the present invention provides a multimodal sensor fusion orthosis and a monitoring method, which are used to solve the technical problem that the existing orthosis is unable to monitor multiple parameters and adjust the tightness of the orthosis in real time during the correction process, resulting in the inability to ensure the safety and effectiveness of the brace wearing and prone to safety hazards.

[0062] In order to make the purpose, features and advantages of the present invention more obvious and easy to understand, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the embodiments described below are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0063] See also Figure 1 and Figure 2 , Figure 1 A schematic diagram of the structure of a multi-modal sensing fusion orthosis provided by an embodiment of the present invention, Figure 2 A right view and a left view of a multimodal sensing fusion orthosis provided in an embodiment of the present invention.

[0064] The present invention provides a multi-modal sensing fusion orthosis, comprising an orthosis brace 1, a flexible sensing unit 2, a signal processing unit 3 and a data terminal 4;

[0065] The orthotic brace 1 is an integrally formed structure whose shape is adapted to the user's spine and whose tightness can be adjusted;

[0066] The flexible sensing unit 2 is installed in the pressure area inside the orthosis brace 1, and is used to detect the state data of the pressure area and send it to the signal processing unit 3;

[0067] The signal processing unit 3 is installed on the outside of the orthosis brace 1, and is used to perform analog-to-digital conversion on the status data and upload it to the data terminal 4;

[0068] The data terminal 4 is in communication with the signal processing unit 3 and is used to output instruction information according to the comparison result between the state data and the preset state threshold value, so as to remind the user to adjust the tightness of the orthosis brace 1.

[0069] Orthotic brace 1 refers to a device used to correct body deformities or assist body functions, including at least one notch for adjusting the tightness of the brace, such as Figure 1 As shown. Specifically, it can be divided into two types: soft and hard. Soft spinal orthoses are usually made of elastic materials and can provide mild support and correction. Rigid spinal orthoses are made of plastic or metal materials and can provide stronger support and correction. In this embodiment, the specific structure of the orthotic brace 1 can be established by means of plaster molding or 3D scanning to establish a corresponding model, and the model is adjusted and corrected in combination with medical images to set different pressure areas, pressure release areas and support areas according to the user's physical condition, and then the orthotic brace 1 is integrally formed. Among them, the pressure area is the main source of correction driving force; the pressure release area is designed with holes in the depressed area of ​​the spine or soft tissue to release pressure; the support area involves the longitudinal verticality and stretching of the soft tissue to avoid further collapse of the depressed area.

[0070] The flexible sensing unit 2 refers to a sensing unit made of flexible materials, including but not limited to a pressure sensing unit 21 and a temperature sensing unit 22. The flexible sensing unit 2 can be integrated into a flexible PCB to improve the flexibility of sensing monitoring and adapt to various complex shapes and space requirements. In the field of orthopedics, a "three-point force" system is constructed to set three support points at specific parts of the body and apply appropriate pressure and tension to adjust the position and shape of the bones and promote the correction of deformities. Therefore, in this embodiment, a group of flexible sensing units 2 can be arranged on the thoracolumbar area, lumbar side and inner side of the pelvic area of ​​the orthotic brace 1. Different types of scoliosis users require different specific pressure positions, and the corresponding implementation positions of the flexible sensing units 2 can be adjusted accordingly.

[0071] The data terminal 4 refers to a computer device, mobile phone application APP or terminal that can directly output control commands. The detected pressure voltage data and temperature voltage data are processed by digital signals on the mobile phone and the waveforms and values ​​are displayed in real time. At the same time, the respiratory components reflected by the pressure voltage data are extracted by frequency analysis method, and the respiratory rate data is updated regularly.

[0072] In the embodiment of the present invention, the spinal condition of the user is obtained by plaster molding or 3D scanning and a corresponding model is constructed. Different pressure application areas, pressure release areas and support areas are set in the model according to the spinal condition of the user, and an integrated structure with a shape adapted to the user's spine and adjustable tightness is manufactured as an orthotic brace 1. The signal processing unit 3 is installed on the outside of the orthotic brace 1, the flexible sensing unit 2 is placed on the inside of the pressure application area of ​​the orthotic brace 1, and a detachable FPCB (Flexible Printed Circuit Board) wire is used to pass through the through hole located in the pressure release area or other positions to connect the flexible sensing unit 2 and the signal processing unit 3, so that the state data of the pressure application area is detected by the flexible sensing unit 2 and sent to the signal processing unit 3 along the wire.

[0073] In order to facilitate the subsequent data processing of the data terminal 4 and reduce the cost of the orthosis, the signal processing unit 3 only retains the analog-to-digital conversion function and the data receiving and sending function, and performs analog-to-digital conversion on the status data after receiving it and uploads it to the data terminal 4. The data terminal 4 outputs the indication information according to the comparison result between the digitized status data and the preset status threshold, thereby reminding the user or orthotist to adjust the tightness of the orthosis bracket, realizing the multi-parameter monitoring of the pressure and temperature in the orthosis brace 1, and effectively ensuring the safety of the user.

[0074] It should be noted that the orthosis bracket may also be provided with an intelligent adjustment component, which is connected to the signal processing unit 3. After the signal processing unit 3 receives the indication information output by the data terminal 4, the tightness can be adjusted in real time according to the specific content of the indication information, thereby further improving the intelligence level and adjustment flexibility of the orthosis.

[0075] In a specific implementation, the flexible sensing unit 2 and the signal processing unit 3 can be integrated in the flexible circuit to facilitate the installation of orthotic braces 1 of various shapes. After the program is burned into the flexible circuit, the signal processing unit 3 in the flexible circuit is attached to the outside of the orthotic brace 1, and the flexible sensing unit 2 is led out through a detachable FPCB wire and attached to a designated force-bearing position on the inside of the orthotic brace 1, so as to monitor the pressure of the orthotic brace 1 in real time.

[0076] Optionally, the orthosis further comprises a pressure adjustment component 5;

[0077] The orthotic brace 1 is also provided with a plurality of pressure release holes;

[0078] The pressure adjustment component 5 is movably connected to the movable end of the orthotic brace 1 and is used for gradiently adjusting the tightness of the orthotic brace 1 to adjust the pressure of the pressure-applying area.

[0079] The pressure adjustment component 5 refers to a component or structure that can adjust the tightness of the orthotic brace 1, such as an orthotic strap or magic tape. When the orthotic is worn for the first time, the orthotic technician designs an orthotic scheme for adjusting the device based on the patient's three-dimensional trunk scan, trial pressure data, and the length of the front strap of the orthotic. Different fixed points can be marked on the strap to adjust the reference strap length for the trunk orthotic pressure adjustment at different stages of the orthosis. During the actual orthosis, the user can adjust the strap length according to the reference position and the corresponding correction stage, and further fine-tune it according to the corresponding pressure sensing data results.

[0080] In this embodiment, the pressure release area of ​​the orthotic brace 1 may be provided with a plurality of pressure release holes for releasing pressure and avoiding excessive pressure. The movable end of the orthotic brace 1 is movably connected by the pressure adjustment component 5. The orthotic brace 1 has a certain elasticity. By adjusting the pressure adjustment component 5, the tightness of the orthotic brace 1 is adjusted, thereby adjusting the pressure in the pressure area.

[0081] Optionally, the orthotic brace 1 is provided with a through hole, and the flexible sensing unit 2 is connected to the signal processing unit 3 via the through hole;

[0082] The flexible sensing unit 2 includes a plurality of pressure sensing units 21 and a plurality of temperature sensing units 22, and the state data includes pressure voltage data and temperature voltage data;

[0083] The pressure sensing unit 21 and the temperature sensing unit 22 are attached to the inner surface of each pressure application area in pairs, and are used to detect the pressure voltage data and the temperature voltage data of each pressure application area.

[0084] In this embodiment, according to the "three-point force" system, a group of pressure sensing units 21 and temperature sensing units 22 are attached to the inner surface of each pressure area of ​​the orthosis brace 1 to monitor the pressure and temperature changes of the main pressure areas of the scoliosis patient, such as the thoracic region, thoracolumbar region, lumbar side and pelvic region. Since different types of scoliosis patients require different specific pressure positions, the corresponding sensor unit implementation positions need to be adjusted accordingly to achieve personalized orthopedic rehabilitation.

[0085] In actual use, the required sensor array and area can be designed according to the type and degree of scoliosis of the user, such as 1 cm by 3×3 arrangement. 2 The flexible pressure sensing unit 21 obtains the pressure distribution and changes in the pressure application area corresponding to the larger scoliosis angle. In addition, in order to assist in pressure monitoring and assessing the comfort of the brace and user adaptability, at least one group of pressure sensing units 21 can be set in the chest area to monitor the user's respiratory function.

[0086] To prevent the sensor unit from sliding relative to the inner side of the orthosis brace 1, a medical breathable tape is used to fix the flexible sensor unit 2 to the inner surface of the brace, and a through hole is designed to lead the wire to the outside of the orthosis. The temperature sensor unit 22 can be a platinum thermistor assembly.

[0087] In order to ensure wearing comfort, the thickness of the sensor device is limited. The sensing area of ​​the pressure sensing unit 21 is 1×1 cm 2 The thickness of the pressure sensing unit 21 is 0.5 mm to 1 mm; the sensing area of ​​the temperature sensing unit 22 is 2×2.3 mm 2 , the thickness of the temperature sensing unit 22 is 0.8 mm to 1.2 mm.

[0088] In one example of the present invention, the pressure sensing unit 21 includes a flexible sensing layer 211 and a flexible electrode layer 212 encapsulated by an encapsulation layer;

[0089] The flexible sensing layer 211 is an array structure with a micro-dome shape on one side and in contact with the flexible electrode layer 212;

[0090] The material of the encapsulation layer is polyethylene terephthalate;

[0091] The surface of the flexible electrode layer 212 has a conductive material coating.

[0092] In this embodiment, the pressure sensing unit 21 includes a surface structured flexible sensing layer 211, a flexible electrode layer 212 and a packaging layer, and is connected to the signal processing unit 3 through a wire. The sandwich structure is used to sandwich the sensing layer with the structure facing the electrode layer and the Au-plated interdigital electrodes between ultra-thin PET (Polyethylene terephthalate) packaging layers. The thickness of the ultra-thin PET packaging layer is 10 The selection of flexible substrate materials, surface microstructures, and internal multi-level sensing coupling structures provide the sensor with shape adaptability, high sensitivity, and a wide response range, as well as long-term dynamic stability, meeting the requirements for internal use of orthotics.

[0093] Among them, the flexible electrode layer 212 can be a flexible electrode layer 212 covered with a conductive material coating, and the conductive material can be a metal material with high conductivity, such as a single coating material such as gold, copper, silver, or a composite coating material such as a silver-based composite coating, a copper-based composite coating, and a nickel-based composite coating. The embodiment of the present application does not limit the specific conductive material coating.

[0094] In an example of the present invention, the flexible sensing layer 211 is prepared by taking structured polydimethylsiloxane as a matrix and doping carbon nanotubes and silver particles therein.

[0095] The flexible sensing layer 211 can produce different deformations and internal conductive paths according to the size of the applied pressure. The micro-dome-shaped structure of its surface is conducive to reducing the initial contact area between the flexible sensing layer 211 and the flexible electrode layer 212, increasing the deformation space and sensing sensitivity. The internal conductive materials of the flexible sensing layer 211, such as carbon nanotubes, graphene, silver powder, MXene, etc. dispersed inside, form a conductive micro-network, reach the conductive threshold, and achieve rapid response to pressure changes. At the same time, the flexible sensing layer 211 achieves sensitive response to applied pressure and microstructure tip loss suppression in the form of a flat surface microstructure and an internal multi-level sensing group, thereby improving cycle stability. The structure of the pressure sensing unit 21 meets the conformal fit of the orthosis, and the part in contact with the skin ensures patient comfort. The presence of transition metal elements in the MXene material gives it a metal-like conductivity and high conductivity, which makes it have great application potential in the fields of electronic devices, energy storage devices, etc. For example, it can be used as an electrode material for supercapacitors and batteries, which can improve the charge and discharge rate and energy density of energy storage devices.

[0096] Carbon Nanotubes (CNT) are a material with a special structure and excellent properties. It is a cylindrical structure formed by curling graphite sheets, with a diameter generally ranging from one nanometer to several hundred nanometers, a length of several micrometers to several thousand micrometers, and an aspect ratio (ratio of length to diameter) ranging from one thousand to one hundred thousand.

[0097] In this embodiment, the flexible sensing layer 211 uses structured PDMS (Polydimethylsiloxane) as a matrix, carbon nanotubes and silver powder particles are dispersed inside, and a micro dome array structure is designed and prepared on one side of the sensing layer, which is in contact with the Au interdigital electrode. Figure 3 As shown. The carbon nanotubes in the flexible sensing layer 211 form a conductive micro-network, and the silver particles are evenly distributed in the matrix as a response amplification enhancement phase. The multi-level dispersion of the internal conductive doped filler realizes the uniform dispersion of the silver powder and the rapid reduction of the resistance of the conductive network under a small deformation, that is, the sensing sensitivity is amplified. The surface-smooth microstructure provides better compressibility and sensitivity for the sensing layer, and also avoids the tip aggregation of the conductive particles and the tip loss under the action of cyclic pressure. Compared with the microstructure with a larger aspect ratio, the tangential deformation of the structural array is very small, which reduces the crosstalk caused by the relative friction between the skin or clothing and the sensor.

[0098] Furthermore, the preparation process of the flexible sensing layer 211 includes the following steps S11-S18:

[0099] S11, use continuous ultrasound or pulse ultrasound to disperse the outer diameter of 20nm~30nm and length of 0.5 ~2 and stirring for 30 min to obtain a carbon nanotube dispersion;

[0100] S12, add n-hexane to the polydimethylsiloxane base liquid, mix and stir for 15 minutes, then add a 5 The silver powder is dispersed by ultrasonic stirring to obtain a silver particle dispersion;

[0101] S13, adding the carbon nanotube dispersion to the silver particle dispersion, mixing and stirring for 14 h to 18 h, adding a curing agent and stirring at room temperature for 1 h to obtain a carbon nanotube-silver powder two-phase dispersion;

[0102] S14, baking the pretreated aluminum substrate at 65° C. and 95° C. respectively, and spin coating the photoresist;

[0103] S15, covering the aluminum substrate after spin coating the photoresist with a micro-dome-shaped mask and exposing it to ultraviolet light for 18s to 21s, and performing post-baking at 65° C. and 95° C. respectively;

[0104] S16, after post-baking, the aluminum substrate is added with a developer and hardened at 150°C for 30 minutes, cooled to room temperature and then anodized in an oxalic acid solution for 19 hours to 24 hours;

[0105] S17, etching the anodized aluminum substrate with a chromic acid and phosphate mixed solution to obtain an aluminum-based template having a micro-dome-shaped mask structure;

[0106] S18, pouring the carbon nanotube-silver powder dual-phase dispersion into the fluorinated aluminum-based template, curing at 70° C. for 12 h and demolding to obtain a flexible sensing layer 211.

[0107] In the embodiment of the present invention, isopropanol is used to ultrasonically disperse the outer diameter of 20nm~30nm and the length of 0.5 ~2 Short multi-walled carbon nanotubes. Continuous ultrasound or pulsed ultrasound can be used to achieve the dispersion, with an ultrasonic dispersion concentration of 0.02-1wt%, an effective ultrasonic time of 1 h or more, and stirring for 30 min after ultrasound to obtain a carbon nanotube dispersion. n-Hexane is added to the polydimethylsiloxane (PDMS) base liquid and stirred for 15 min to reduce the viscosity of PDMS, and then a 5 Ultrafine silver powder was ultrasonically stirred and dispersed, the effective ultrasonic time was 30 min, and the stirring and dispersion time was 1 h, so as to obtain a suspension of silver powder in PDMS base liquid, that is, a silver particle dispersion. After adding carbon nanotube dispersion to the silver particle dispersion and mixing and stirring for 14h~18h, a curing agent was added and continued to stir at room temperature for 1h to obtain a carbon nanotube-silver powder two-phase dispersion. Among them, the content of carbon nanotubes in the matrix ranges from 3 wt% to 7wt%, and the ratio of PDMS to silver powder is 5~11:1. Different degrees of sensing performance gain effect can be obtained according to different ratios.

[0108] At the same time, the micro-dome-shaped mask is designed according to the preset size and arrangement. The matrix array can be 80 mm in diameter. The circle is the basic pattern, and the distance between adjacent circle centers is 160 , the total array area is 5 × 5 cm 2 . The array arrangement and unit structure size of the micro-dome-shaped mask can be designed and adjusted according to the needs. Then the aluminum substrate is pre-treated by decontamination, polishing and pre-oxidation to improve the affinity with the photoresist in the subsequent process. Then the pre-treated aluminum substrate is soft-baked at 65°C and 95°C for 1-3 min and 5-10 min respectively, and then the photoresist is spin-coated. After the micro-dome-shaped mask is covered on the aluminum substrate after spin-coating the photoresist and exposed to ultraviolet light for 18s~21s, it is post-baked at 65°C and 95°C respectively. After adding the developer to the post-baked aluminum substrate, it is hardened at 150°C for 30min, cooled to room temperature, and anodized in oxalic acid solution for 19h~24h; then, the anodized aluminum substrate is acid-etched with a mixed solution of phosphoric acid and chromic acid to remove the photoresist, thereby obtaining an aluminum-based template with a negative template structure, that is, an aluminum-based template with a micro-dome-shaped mask structure. According to the different photolithography exposure time, photoresist thickness and oxidation time, the actual size of the negative template structure is adjusted to obtain a diameter of 95 -100 , the distance between adjacent microstructures is 160 , height 30 ~40 A rectangular array of .

[0109] After the preparation of the carbon nanotube-silver powder dual-phase dispersion and the aluminum-based template is completed, the aluminum-based template is fluorinated, and then the carbon nanotube-silver powder dual-phase dispersion is poured in, and after curing at 70° C. for 12 hours or overnight, the flexible sensing layer 211 is demolded.

[0110] For the convenience of subsequent use, the flexible sensing layer 211 can also be cut into 1×1 cm 2 size.

[0111] like Figure 4 As shown, in one example of the present invention, the signal processing unit 3 includes a main control module 34 and a connector, a power management module, a pressure conversion circuit and a temperature conversion circuit respectively connected to the main control module 34;

[0112] A power management module, used to supply power to the main control module 34, the pressure conversion circuit and the temperature conversion circuit;

[0113] The pressure conversion circuit is connected to the flexible sensing unit 2 via a connector;

[0114] The temperature conversion circuit includes a Wheatstone bridge circuit and a staged amplifier circuit connected in sequence;

[0115] The Wheatstone bridge circuit is connected to the flexible sensing unit 2 through a connector, and the hierarchical amplification circuit is connected to the main control module 34;

[0116] The main control module 34 is used to perform analog-to-digital conversion on the status data and upload the converted data to the data terminal 4 .

[0117] In this embodiment, the pressure sensing unit 21 and the temperature sensing unit 22 in the flexible sensing unit 2 are respectively connected to the signal processing unit 3 through wires. The signal processing unit 3 may include a main control module 34, and a connector, a power management module, a pressure conversion circuit, and a temperature conversion circuit respectively connected to the main control module 34.

[0118] The power management module provides power for the main control module 34 , the pressure conversion circuit and the temperature conversion circuit. It may include a button battery base 31 for replacing button batteries, and may also include an external power supply test interface 32 for testing the signal processing unit 3 .

[0119] The connector may be an FPC (Flexible Printed Circuit) connector, which is used to connect a flexible printed circuit board and other electronic devices, such as the flexible sensing unit 2 .

[0120] The pressure conversion circuit is connected to the pressure sensing unit 21 in the flexible sensing unit 2 through a connector, and is specifically a resistance voltage divider circuit. The resistance change value detected by the pressure sensing unit 21 is converted into a voltage value. At the same time, the temperature conversion circuit also includes a graded amplification circuit, which converts the temperature sensitive signal into a voltage signal through a Wheatstone bridge circuit, and enhances the resistance change through at least two stages of amplification circuits to improve data accuracy.

[0121] It should be noted that a Bluetooth chip can be used as the main control module 34 for embedded development. It has an 8 to 14-bit ADC and serial port transparent transmission function, can realize near-field communication with the host computer, and realize data conversion and sending functions. After analog-to-digital conversion of the voltage signal representing pressure and temperature, it is sent to the data terminal 4.

[0122] In a specific implementation, the pressure and temperature sensing circuit can be integrated into a flexible PCB, and the flexible circuit includes a data acquisition circuit, a main control module 34, an external circuit, and a connector module 33. Figure 6 As shown, the pressure and temperature signals are collected by the Bluetooth chip as the main control module 34. The chip has a corresponding chip antenna 35 and a program burning interface 36. The button battery is installed on the button battery base 31 for power supply. After the program is burned, the flexible sensing unit 2 is led out through the detachable FPCB wire on the connector module 33 and fixed to the specified force position on the support. After collecting the pressure voltage signal and the temperature voltage signal, the internal analog-to-digital conversion is called to convert the analog voltage signal into a digital signal, and the serial port transparent transmission function is used to package and send the data at a specified rate. In addition, the external power supply can be connected to the device through the external power supply test interface 32 to test the performance and stability of the device under different power supply conditions, and a flexible way to test the power management system of the device is provided. The parameters of the external power supply can be adjusted to observe the response of the device to optimize the power supply design and improve the performance of the device.

[0123] In one example of the present invention, the data terminal 4 is specifically used for:

[0124] When the pressure voltage data and the temperature voltage data are received, the temperature voltage data is converted to obtain the temperature data;

[0125] Convert the pressure voltage data to obtain pressure data;

[0126] After the pressure voltage data buffer is filled to the buffer array, the buffer array is subjected to frequency domain analysis, the main component of the signal frequency is selected as the respiratory rate data and the buffer array is cleared;

[0127] The respiratory rate data, temperature data and pressure data are compared with the preset state thresholds respectively, and prompt information is generated according to the comparison results.

[0128] In this embodiment, the data terminal 4 can be implemented based on the Android system and has functions such as data transmission and reception and data analysis and processing. After the data terminal 4 receives the pressure voltage data and the temperature voltage data, the pressure data and the temperature data are converted according to the specific value changes of the resistor through its embedded pressure, temperature conversion and respiratory rate extraction module, and the respiratory components are feature extracted through the frequency analysis method, and the respiratory rate data is updated regularly. In addition, a display interface can also be included for real-time display of the pressure reference value, the pressure value and the waveform, the real-time temperature and the real-time respiratory signal.

[0129] The conversion process of pressure data can be as follows:

[0130] By performing a gradient pressure test on the pressure sensor, a series of pressure-resistance data is obtained, which is printed in a two-dimensional chart in the form of a scatter plot and curve fitting is performed. The pressure-resistance relationship is pre-set according to the scatter plot change trend to meet the mathematical model:

[0131]

[0132] Among them, P is the pressure data (kPa), R is the pressure resistance data (kΩ), and the parameter combination a and b with R square > 0.99 is fitted as the model formula constant, thereby obtaining the pressure-resistance conversion formula. Then, according to the resistor voltage division relationship in the external voltage division circuit of the pressure sensor, the pressure-voltage conversion formula can be obtained.

[0133] The temperature data calculation method is similar. The temperature sensor is tested in an oil bath with a gradient temperature to obtain a series of temperature-voltage data. Since the selected thermistor has a high linearity, it is selected

[0134]

[0135] As a mathematical model of the temperature-voltage conversion formula, where T is temperature (°C) and U is voltage (V), the parameter combinations c and d with R square > 0.99 are fitted as model formula constants to obtain the temperature-voltage conversion formula.

[0136] For respiratory rate calculation, the pressure data needs to be stored in a buffer array. When the buffer array is filled, the frequency domain analysis function is triggered to perform frequency domain analysis on the array through fast Fourier transform, and the main component of the signal frequency is taken as the user's respiratory frequency during this period, and the respiratory rate data is returned.

[0137] In this embodiment, after the respiratory rate data, temperature data and pressure data are calculated, each value is compared with the preset state threshold, and prompt information is generated according to the comparison result, such as Figure 5 As shown, the specific comparison process is as follows:

[0138] After the data terminal 4 receives the status data, it divides the status data into three channels according to the corresponding data channels (i.e., pressure-voltage data of the pressure channel, temperature-voltage data of the temperature channel, and pressure-voltage data of the thorax). For the pressure-voltage data and temperature-voltage data of the same pressure application area, the pressure-voltage formula and the temperature-voltage formula are used for conversion, respectively, to obtain the pressure data and temperature data and display them; for the pressure-voltage data of the thorax, it is filled into the buffer array as a data point until the array is filled, and the buffer array is analyzed in the frequency domain, and the frequency principal component of the signal is taken as the user's breathing frequency during this period, and the breathing rate data is obtained and displayed, and at the same time, the array index is reset to zero and the array is cleared, waiting for the next set of pressure-voltage data of the thorax.

[0139] When the data of the three channels are all lower than the set threshold, it is judged that the user is in an abnormal wearing time or wearing and taking off behavior state, and an alarm is sent to the mobile phone; when only the pressure channel value (i.e., pressure data) is low, it means that the brace may be loose or the user's orthopedic progress may be poor, and it is recommended to wear the brace again or go to the hospital for a reexamination; when the value of a certain channel is higher than the normal threshold and the values ​​of other channels are normal, it reminds the user that there may be a risk of local pressure injury such as local inflammatory reaction, and it is recommended to release the pressure appropriately or consult a brace technician to adjust the brace structure; when the value of any channel far exceeds the threshold, it indicates that an abnormal value detection state has occurred, and the data may be wrong. The terminal does not perform the data recording process or directly notifies the technician.

[0140] When the continuous monitoring time is greater than 1 hour and the following situations occur, if the respiratory rate is high and other parameters are normal, it indicates abnormal cardiopulmonary function; if the respiratory rate is high and the temperature is high, it indicates that the user may have an inflammatory reaction (such as fever); if the respiratory rate is low and other parameters are normal, it indicates that the user may have symptoms related to sleep apnea and an early warning is issued.

[0141] like Figure 6 As shown, Figure 6It is a structural block diagram of a multimodal sensing fusion orthosis in an embodiment of the present invention. Among them, taking the main control module 34 as a Bluetooth main control chip and the data terminal 4 as a mobile phone app as an example, after the flexible sensing unit 2 is attached to the orthosis brace 1, the pressure resistance change value and the temperature resistance change value are obtained through the pressure sensor and the temperature sensor, and the resistance change value is converted through the resistor voltage divider circuit and the Wheatstone bridge, and then converted into corresponding voltage data and transmitted to the Bluetooth main control chip through the external circuit. The Bluetooth main control chip acquires data and converts it into a digital signal in the manner of PPI timer + double buffer interrupt sampling, and transmits it to the mobile phone app through the serial port. After the mobile phone app receives the pressure voltage data and temperature voltage data in the form of digital signals, it analyzes them and calculates the corresponding temperature data and pressure data in combination with the internal pressure and temperature conversion calculation formula. At the same time, the respiratory rate is calculated according to the pressure voltage data, and the corresponding waveform and value are displayed.

[0142] In this embodiment, pressure monitoring is used to determine whether the user wears the brace correctly according to the doctor's instructions and whether the wearing time is sufficient, that is, the user's quality compliance and time compliance are verified. At the same time, pressure monitoring is used to evaluate whether the brace is suitable for the user's body shape and scoliosis condition, and to make timely brace fine-tuning in the face of changes in scoliosis angle during correction or changes in body weight or height that cause poor fit. The risk of pressure injury to the user is assessed by comprehensive pressure, temperature and respiratory monitoring results, and the brace correction effect is monitored and evaluated over a long period of time, providing a decision-making basis for orthotists and doctors to formulate and improve orthopedic treatment plans.

[0143] In an embodiment of the present invention, a flexible pressure sensor device for mechanical adaptation of a scoliosis orthosis is prepared by means of surface microstructure and internal multi-stage sensor coupling. The deformation capacity of the flexible substrate is enhanced by a flat surface microstructure, and the pressure response is enhanced and the response range is increased. On the other hand, the internal multi-stage sensor coupling compensates the sensor sensitivity in a manner that two or more conductive fillers are effectively dispersed. Through the above two measures, the sensitivity and sensing range of the specimen are greatly improved, while the loss of the structure tip is suppressed and the dynamic stability of the sensor is enhanced. This provides a basis for long-term dynamic pressure monitoring inside the orthosis, while ensuring conformal fit with the pressure application area, reducing measurement errors, avoiding skin irritation caused by rigid equipment, and providing better comfort for the user during the orthosis process. In addition, the pressure sensor and the temperature sensor are integrated, and the acquisition circuit and the signal conversion system are designed separately. The signal sources are independent of each other, crosstalk is avoided, and the accuracy of temperature and pressure monitoring inside the orthosis is ensured. In addition, the signal processing unit 3 and the flexible sensor unit 2 carried by the orthosis have the advantages of small size, convenient carrying and use, and the weight and volume increment are very small compared to ordinary orthosis. The data terminal 4 or APP facilitates users, orthotists and doctors to track wearing compliance and correction progress in real time and manage data regularly. It not only solves the problems of lack of quality compliance and time compliance supervision of scoliosis users, but also can realize pressure injury warning and correction pressure standardization during the correction process of users, effectively ensuring the safety and effectiveness of the treatment process.

[0144] See also Figure 7 , Figure 7 A flowchart showing the steps of a multi-modal sensing fusion orthopedic monitoring method according to an embodiment of the present invention is shown.

[0145] An embodiment of the present invention provides an orthosis monitoring method of multimodal sensing fusion, which is applied to an orthosis of multimodal sensing fusion as in any embodiment of the present invention, and the method comprises the following steps:

[0146] Step 701, when the orthosis brace 1 is worn by the user, the data terminal 4 sends a monitoring start instruction to the signal processing unit 3 to start the flexible sensing unit 2;

[0147] In the embodiment of the present invention, the surface micro-dome structure array counter template is designed and prepared by using photolithography technology and anodized aluminum template method, and carbon nanotubes and silver powder particles are dispersed respectively by using isopropyl alcohol and n-hexane mixed with PDMS. The dispersed doping phases are mixed, and after sufficient stirring, a curing agent is added to the aluminum template for curing and re-molding to obtain a flexible sensing layer 211 with surface microstructure and internal multi-level sensing, and then the Au interdigital electrodes and PET packaging layer are integrated to obtain a pressure sensing unit 21. The pressure sensing unit 21 and the temperature sensing unit 22 are integrated in a flexible PCB to obtain a flexible sensing unit 2.

[0148] After the orthotic brace 1 is prepared according to the user's spinal condition, the flexible sensing unit 2 and the signal processing unit 3 are attached to the orthotic brace 1, and a communication connection is established between the signal processing unit 3 and the data terminal 4. A monitoring start instruction is sent to the signal processing unit 3 through the APP on the data terminal 4 to start the flexible sensing unit 2 to start data collection.

[0149] Step 702, obtaining state data of each pressure application area in the orthosis brace 1 through the flexible sensing unit 2 according to a preset period, and transmitting the data to the signal processing unit 3;

[0150] After the flexible sensing unit 2 is started, the state data of each pressure application area in the orthosis brace 1, such as pressure voltage data and temperature voltage data, is acquired according to a preset cycle and transmitted to the signal processing unit 3.

[0151] Step 703, converting the state data into analog-to-digital data by the signal processing unit 3, and uploading the converted data to the data terminal 4;

[0152] Step 704 , the data terminal 4 outputs instruction information according to the comparison result between the state data and the preset state threshold value, so as to remind the user to adjust the tightness of the orthosis brace 1 .

[0153] After the data terminal 4 receives the status data, it obtains the pressure value and waveform of the orthosis pressure area from the status data, calculates the respiratory frequency, obtains the temperature value and waveform information, compares the measured pressure value with the reference pressure value within the normal range, compares the respiratory signal with the reference respiratory rhythm, and comprehensively evaluates the risk of orthopedic pressure injury in the scoliosis orthopedic area in combination with the temperature changes in the corresponding area, thereby outputting corresponding prompt information to remind the user to adjust the tightness of the orthosis brace 1.

[0154] In this embodiment, when the orthosis brace 1 is worn by the user, the data terminal 4 sends a monitoring start instruction to the signal processing unit 3 to start the flexible sensing unit 2; the flexible sensing unit 2 obtains the state data of each pressure zone in the orthosis brace 1 according to a preset period, and transmits it to the signal processing unit 3; the signal processing unit 3 performs analog-to-digital conversion on the state data and uploads it to the data terminal 4; the data terminal 4 outputs an indication information according to the comparison result between the state data and the preset state threshold value to remind the user to adjust the tightness of the orthosis brace 1. Thus, the pressure of the pressure zone of the orthosis brace 1 is monitored in real time by the flexible sensing unit 2, and the pressure damage of the user's spine during the correction process is warned in real time, effectively ensuring the safety of the correction process.

[0155] In the several embodiments provided by the present invention, it should be understood that the disclosed devices and methods can be implemented in other ways. For example, the device embodiments described above are only schematic. For example, the division of the modules is only a logical function division. There may be other division methods in actual implementation, such as multiple modules or components can be combined or integrated into another system, or some features can be ignored or not executed. Another point is that the mutual coupling or direct coupling or communication connection shown or discussed can be through some interfaces, indirect coupling or communication connection of devices or modules, which can be electrical, mechanical or other forms.

[0156] As described above, the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features thereof may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A multimodal sensor fusion orthosis, characterized in that: It includes an orthotic brace, a flexible sensing unit, a signal processing unit and a data terminal; The orthotic brace is an integrally formed structure whose shape is adapted to the user's spine and whose tightness can be adjusted; The flexible sensing unit is installed at the pressure application area inside the orthosis brace, and is used to detect the state data of the pressure application area and send it to the signal processing unit; The signal processing unit is installed on the outside of the orthotic brace, and is used to perform analog-to-digital conversion on the status data and upload it to the data terminal; The data terminal is in communication with the signal processing unit and is used to output instruction information according to the comparison result between the state data and the preset state threshold value, so as to remind the user to adjust the tightness of the orthotic brace.

2. The orthosis according to claim 1, characterized in that Also included is a pressure adjustment assembly; The orthotic brace is also provided with a plurality of pressure release holes; The pressure adjustment component is movably connected to the movable end of the orthotic brace and is used to gradually adjust the tightness of the orthotic brace to adjust the pressure of the pressure area.

3. The orthosis according to claim 1, characterized in that The orthotic brace is provided with a through hole, and the flexible sensing unit is connected to the signal processing unit via the through hole; The flexible sensing unit includes multiple groups of pressure sensing units and multiple groups of temperature sensing units, and the state data includes pressure voltage data and temperature voltage data; The pressure sensing unit and the temperature sensing unit are attached to the inner surface of each of the pressure application areas in pairs, and are used to detect pressure voltage data and temperature voltage data of each of the pressure application areas.

4. The orthosis according to claim 3, characterized in that The sensing area of ​​the pressure sensing unit is 1×1 cm 2 , the thickness of the pressure sensing unit is 0.5mm~1mm; The sensing area of ​​the temperature sensing unit is 2×2.3 mm 2 , the thickness of the temperature sensing unit is 0.8mm~1.2mm.

5. The orthosis according to claim 3, characterized in that The pressure sensing unit comprises a flexible sensing layer and a flexible electrode layer encapsulated by an encapsulation layer; The flexible sensing layer is an array structure with one side in a micro-dome shape and in contact with the flexible electrode layer; The material of the encapsulation layer is polyethylene terephthalate; The surface of the flexible electrode layer has a conductive material coating.

6. The orthosis according to claim 5, characterized in that The flexible sensing layer is prepared by taking structured polydimethylsiloxane as a matrix and doping carbon nanotubes and silver particles inside.

7. The orthosis according to claim 5 or 6, characterized in that The preparation process of the flexible sensing layer comprises: Continuous ultrasound or pulsed ultrasound is used to disperse the outer diameter of 20nm~30nm and the length of 0.5 ~2 and stirring for 30 min to obtain a carbon nanotube dispersion; After adding n-hexane to the polydimethylsiloxane liquid and stirring for 15 minutes, add The silver powder is dispersed by ultrasonic stirring to obtain a silver particle dispersion; Add the carbon nanotube dispersion to the silver particle dispersion, mix and stir for 14 to 18 hours, then add a curing agent and stir at room temperature for 1 hour to obtain a carbon nanotube-silver powder two-phase dispersion; The pretreated aluminum substrate is baked at 65° C. and 95° C. respectively, and a photoresist is spin-coated; The aluminum substrate after spin coating with photoresist was covered with a micro-dome-shaped mask and exposed to ultraviolet light for 18s-21s, and post-baked at 65°C and 95°C respectively; After post-baking, the aluminum substrate is added with developer and hardened at 150°C for 30 minutes. After cooling to room temperature, it is anodized in oxalic acid solution for 19 hours to 24 hours. The aluminum substrate after anodization is acid-etched by using a mixed solution of chromic acid and phosphate to obtain an aluminum-based template with a micro-dome-shaped mask structure; The carbon nanotube-silver powder dual-phase dispersion was poured into the fluorinated aluminum-based template, cured at 70° C. for 12 h, and demolded to obtain a flexible sensing layer.

8. The orthosis according to claim 1, characterized in that The signal processing unit includes a main control module and a connector, a power management module, a pressure conversion circuit and a temperature conversion circuit respectively connected to the main control module; The power management module is used to supply power to the main control module, the pressure conversion circuit and the temperature conversion circuit; The pressure conversion circuit is connected to the flexible sensing unit through the connector; The temperature conversion circuit comprises a Wheatstone bridge circuit and a staged amplifier circuit connected in sequence; The Wheatstone bridge circuit is connected to the flexible sensing unit through the connector, and the hierarchical amplification circuit is connected to the main control module; The main control module is used to perform analog-to-digital conversion on the status data and upload the converted data to the data terminal.

9. The orthosis according to claim 3, characterized in that The data terminal is specifically used for: When the pressure voltage data and the temperature voltage data are received, converting the temperature voltage data to obtain temperature data; Converting the pressure voltage data to obtain pressure data; After the pressure voltage data cache is filled to the buffer array, the buffer array is subjected to frequency domain analysis, the main component of the signal frequency is selected as the respiratory rate data and the buffer array is cleared; The respiratory rate data, the temperature data and the pressure data are compared with preset state thresholds respectively, and prompt information is generated according to the comparison results.

10. A multi-modal sensor fusion orthopedic monitoring method, characterized in that: The method applied to the multimodal sensing fusion orthosis according to any one of claims 1 to 9 comprises: When the orthotic brace is worn by the user, the data terminal sends a monitoring start instruction to the signal processing unit to start the flexible sensing unit; Acquiring state data of each pressure application area in the orthosis brace through the flexible sensing unit according to a preset period, and transmitting the data to the signal processing unit; Performing analog-to-digital conversion on the status data through the signal processing unit, and uploading the converted data to the data terminal; The data terminal outputs instruction information according to the comparison result between the state data and the preset state threshold value to remind the user to adjust the tightness of the orthotic brace.

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