Method and device for evaluating the effective wearing quality of a scoliosis orthosis

Abstract

This invention discloses a method and device for evaluating the effective wearing quality of a scoliosis orthosis. The invention first constructs effective wearing gating conditions based on contact confidence and its contact stability characteristics within a preset time window. When the effective wearing gating conditions are met, a delivery calibration benchmark is invoked, and the current posture or movement state is identified based on posture / movement-related data. Then, based on the current posture or movement state, the corresponding state benchmark is invoked to evaluate the pressure effectiveness of pressure-related data in different states, calculate pressure effectiveness parameters, and then combine posture / movement matching parameters and time window stability parameters to calculate the effective wearing quality index. This allows for a quantitative assessment of whether the patient's daily wearing status consistently meets the delivery calibration benchmark, thereby enabling the differentiation, duration statistics, and prompt output of states such as not wearing, insufficient wearing contact, abnormal pressure application, and effective wearing.

Description

Technical Field

[0001] This invention relates to the technical field of medical orthopedic devices, and in particular to the technical field of scoliosis orthotics. Background Technology

[0002] Scoliosis (also known as spinal curvature) is one of the most common spinal deformities in adolescents. It is usually manifested as the spine deviating from the normal midline in the coronal plane, often accompanied by vertebral rotation, thoracic deformity, and abnormal physiological curvature. For patients in the growth and development stage, timely detection and intervention in the early and middle stages of the disease can usually delay or stop the progression of the deformity through conservative treatment. Among various conservative treatment methods, scoliosis orthotics are one of the commonly used non-surgical intervention methods due to their clear clinical application.

[0003] Currently used scoliosis orthotics primarily rely on their pre-designed structure for passive correction. The corrective effect depends mainly on the shape of the device, the placement of pressure points, and the tightness of the straps. They lack the ability to provide real-time perception and quantitative analysis of the wearing process and the state of the corrective effect. Therefore, medical staff typically still need to rely on patient feedback, regular outpatient follow-ups, and imaging results to assess the corrective effect, making it difficult to continuously and objectively monitor the patient's actual wearing habits and the quality of the correction in daily life. Specifically, existing non-surgical spinal correction techniques have several significant shortcomings: 1) Difficulty in achieving continuous quantitative monitoring of the wearing process: Existing clinical assessment methods mostly rely on regular follow-up examinations and X-ray imaging. Although they can observe outcome indicators such as changes in the Cobb angle, they have problems such as long cycles, poor real-time performance, and radiation exposure. They are difficult to reflect dynamic information such as whether the pressure in the target area is continuous, whether the orthosis fits stably with the body, and whether the effective wearing time is up to standard during the daily wearing process. 2) Lack of unified quantitative evaluation standards for effective wearing status: Although existing orthotics can achieve orthopedic intervention through asymmetric pressure and release structures, there is still a lack of unified quantitative evaluation mechanisms for whether the orthotics forms stable contact with the human body, whether the patient's daily wearing status continuously meets the delivery calibration benchmark, whether the actual force in the target orthopedic area meets the delivery calibration requirements, and whether the pressure still acts on the target area under different postures or movement states. 3) Difficulty in timely identification and prompting of abnormal wearing conditions: In actual use, patients may experience loosening, displacement, improper wearing, local suspension, displacement of pressure area, excessive local pressure, or abnormal compensatory posture. For the above situations, existing orthotics usually cannot identify and prompt in a timely manner, and medical staff also have difficulty in timely grasping the patient's wearing status outside the hospital.

[0004] With the development of sensing and smart wearable technologies, existing technologies have introduced scoliosis orthotics with monitoring functions, such as a smart pressure monitoring 3D-printed scoliosis orthotide with announcement number CN113317918B, a sensor-based flexible scoliosis orthotics and monitoring brace with publication number CN121101838A, and a pressure-adjustable 3D-printed scoliosis orthotide with publication number CN116531154A. However, the technical focus of the above-mentioned monitoring solutions is mainly on the acquisition, display, and adjustment of local pressure parameters. Even if real-time pressure values ​​or pressure-time change information can be obtained, they mainly reflect the local pressure state. There is still a lack of a unified comprehensive evaluation mechanism for issues such as whether a stable fit is formed between the orthotide and the human body, whether the patient's daily wearing status continuously meets the delivery calibration benchmark, whether the actual force in the target orthopedic area meets the individualized delivery calibration requirements, and whether the pressure still acts on the target area under different postures or movement states.

[0005] In summary, existing technologies not only struggle to effectively identify differences in the wear state during the wearing process, but also fail to objectively determine whether the patient's daily wear state consistently maintains the effective wear state specified in the delivery calibration. Furthermore, existing solutions still have limited capabilities in continuously recording, tracing historical data, and providing clinical auxiliary analysis throughout the entire wear process, making it difficult to provide sufficient evidence for subsequent wear adjustments, abnormal alerts, and clinical follow-ups. Summary of the Invention

[0006] To address the aforementioned issues, this invention provides a method and apparatus for evaluating the effective wearing quality of a scoliosis orthosis. This method can jointly monitor the contact state, pressure state, and posture / movement state during the orthosis wearing process. It uses the effective wearing state confirmed during the patient's initial trial or when the orthosis is delivered as the delivery calibration benchmark. The method quantitatively evaluates whether the patient's daily wearing status consistently meets the delivery calibration benchmark, thereby enabling the differentiation, duration statistics, and prompt output of states such as not wearing, insufficient wearing contact, abnormal pressure, and effective wearing.

[0007] It should be noted that the effective wear quality assessment described in this invention does not directly judge the clinical orthopedic efficacy based on a single pressure value, a single posture angle, or short-term sensor data. Instead, it is used to characterize the degree to which the patient's current wear status is maintained relative to the delivery calibration benchmark, and to provide reference information for patient wear adjustments, guardian reminders, and physician follow-up assessments.

[0008] To achieve the above objectives, this invention proposes a method for evaluating the effective wearing quality of a scoliosis orthosis, comprising the following steps: S101, S101, Data Acquisition: Collect contact-related data, pressure-related data, and posture / motion-related data of the orthotic body (100) during the wearing process, and form a time-series monitoring dataset; S102. Wearing Contact Determination: Calculate the contact confidence level based on the contact-related data. and contact stability characteristics And construct an effective wearable gating function. ; S103, Baseline Call and Status Identification: Calling the Delivery Calibration Baseline And identify the current posture or motion state based on the posture / motion related data. ; S104, Pressure Effectiveness Evaluation: Based on the effective wear gating function When preset conditions are met, based on the current posture or motion state Call the corresponding state baseline Calculate pressure effectiveness parameters ; S105. Quality Assessment and Result Output: Based on the effective wear gating function Pressure effectiveness parameters Posture / motion matching parameters and time window stability parameters Calculate the effective wear quality index Statistics on wearing time and effective wearing time It will also output a prompt message.

[0009] Preferably, in step S101, the contact-related data (acquired by the contact-related acquisition unit) is used to characterize the contact or fit state between the orthosis body and the human body, and is acquired at least by a temperature sensor, and may also be supplemented by at least one of a contact switch, a proximity sensor, and a flexible fit sensor; the pressure-related data (acquired by the pressure acquisition unit) is used to characterize the pressure state of the orthosis body in the target orthotic area, and is acquired at least by a thin-film pressure sensor, and may also be supplemented by at least one of a flexible pressure sensor, a piezoresistive pressure sensor, a capacitive pressure sensor, a flexible array pressure sensor, a piezoelectric pressure sensor, and a fiber optic grating pressure sensor; the posture / motion-related data (acquired by the posture / motion acquisition unit) is used to characterize the posture changes or motion state of the patient during the wearing of the orthosis, and is acquired at least by a posture sensor, and may also be supplemented by at least one of an inertial measurement unit, an accelerometer, a gyroscope, and a posture angle sensor.

[0010] Preferably, in step S101, the time-series monitoring dataset It is expressed as follows: ; in, In order to access the relevant data, For pressure-related data, This is for attitude / motion related data.

[0011] Preferably, in step S102, the contact confidence level Used to characterize the interaction between the orthosis and the human body at any time. The reliability of establishing a wearable contact relationship; the contact stability characteristics. Used to characterize contact confidence Within the preset time window The persistence and stability within, and based on contact confidence. Within the preset time window Continuous compliance time within degree of fluctuation and number of contact interruptions At least one of them is determined; When contact confidence level Reaching the preset contact confidence threshold And contact stability characteristics When preset requirements are met, the effective wear gate function is used. If the condition for stable fit is met, the device proceeds to the subsequent pressure effectiveness evaluation process; otherwise, the effective wear gating function is used. If the condition is deemed not to meet the requirements for stable fit and wearing, and no effective wearing quality evaluation is conducted, or the evaluation result is marked as invalid.

[0012] Furthermore, in step S102, the contact confidence level It is expressed as follows: ; in, For normalized mapping functions, This is a normalized quantity for temperature characteristics. This is a normalized quantity representing the characteristics of the contact switch. To approximate the normalization of detection features, , , For the corresponding weighting coefficients, To determine the bias term; when a certain type of contact feature is not collected, its corresponding weight coefficient is set to 0, or the contact confidence is calculated using the collected contact features. .

[0013] Furthermore, in step S102, the contact stability feature It is expressed as follows: when , and season Otherwise, let ; in, To preset the minimum contact duration, To preset the contact fluctuation threshold, This is a preset threshold for the number of interruptions.

[0014] Furthermore, in step S102, the effective wear gating function It is expressed as follows: ; in, For indicator functions, The preset contact confidence threshold is used; when When the condition is not met, it indicates that the stable fit and wearing conditions are not met, and an effective wearing quality evaluation will not be performed or the effective wearing quality evaluation result will be marked as invalid; when When the condition is met, it indicates that the wearer is in a stable fit and will proceed to the subsequent delivery calibration benchmark matching and state pressure effectiveness evaluation process.

[0015] Preferably, in step S103, the delivery calibration benchmark This data, collected or set to characterize the patient's orthotic wearing position, strap tightness, target pressure area, and wearing posture as confirmed by a doctor or orthodontist to meet preset requirements, includes at least one of the following: reference contact state, reference pressure state, reference posture state, target pressure area, target pressure range, allowable pressure variation range under different postures / movement states, target posture range, allowable posture fluctuation range, and individualized threshold parameters; the posture or movement state... Obtained from posture / motion-related data, including at least one of standing, sitting, lying, walking, bending, turning, and abnormal activities, and determined based on at least one of posture angle, acceleration, angular velocity, rate of posture change, motion periodicity, and state duration.

[0016] Furthermore, in step S103, the delivery calibration benchmark It is determined by at least one of the following: orthopedic design model, doctor's prescription parameters, 3D scan or mold data, initial trial calibration data, historical wearing data and clinical follow-up data, and is entered, stored, retrieved or updated through at least one of the following: monitoring host, mobile terminal, doctor terminal and remote monitoring platform.

[0017] Preferably, in step S104, the current posture or motion state is determined... From delivery benchmark Select the corresponding state reference The corresponding state reference This includes at least one of the following: target pressure region, target pressure range, allowable pressure fluctuation range, target attitude range, and allowable attitude fluctuation range, corresponding to the posture or motion state; the pressure effectiveness parameter Used to characterize pressure-related data and corresponding state benchmarks under the current posture or motion state. The degree of matching; When the pressure within the target pressure region is lower than the corresponding state benchmark When the pressure falls within the target pressure range, it is determined to be insufficient pressure; when the pressure area deviates from the target pressure area or the proportion of pressure outside the target area exceeds the preset offset threshold, it is determined to be pressure deviation; when the local pressure exceeds the preset safety threshold and the duration reaches the preset time, it is determined to be local high pressure; when the pressure effectiveness parameter... When the preset pressure effectiveness threshold is reached, it is determined that the pressure application state meets the effective wearing requirements of the current posture or movement state.

[0018] Furthermore, in step S104, the pressure effectiveness parameter It is expressed as follows: ; in, This is a pressure matching function, based on the degree of matching of pressure amplitude within the target pressure region, pressure duration, pressure fluctuation degree, and the corresponding state reference. The degree of deviation and at least one of the following parameters for calculating pressure effectiveness: the percentage of pressure outside the target area at multiple pressure sampling points or in the case of an array of pressure sensors. .

[0019] Furthermore, in step S105, the attitude / motion matching parameters Used to characterize whether the current posture or motion state conforms to the corresponding state benchmark. The permissible range of attitude or motion is determined based on at least one of attitude angle deviation, motion state classification confidence level, attitude duration, and attitude fluctuation degree; the time window stability parameter Parameters used to characterize pressure effectiveness and / or posture / motion matching parameters Within the preset time window The effective wearability quality index is defined by at least one of the following: the degree of continuous compliance, the degree of fluctuation, and the downward trend. Used to characterize the patient's current wear status relative to the delivery calibration baseline The degree of retention (not directly equivalent to clinical orthodontic efficacy); the duration of wear. The cumulative time used to characterize the establishment of a wearing contact relationship between the orthotic body and the human body; the effective wearing time. This is used to characterize the cumulative time required to further satisfy the following conditions on the basis of established wear contact: stable fit, compliance with delivery calibration, effectiveness of pressure in different states, and stability within a time window.

[0020] Furthermore, in step S105, when the attitude / motion matching parameters... When the preset posture / motion matching conditions are met, the current posture or motion state is determined to conform to the corresponding state reference. The allowed range of posture or movement is specified; otherwise, it is judged as an abnormal posture / movement state.

[0021] Furthermore, in step S105, the effective wearability quality index It is expressed as follows: ; in, The wearable quality evaluation function employs a weighted evaluation method based on pressure effectiveness parameters. Posture / motion matching parameters and time window stability parameters Obtained through calculation.

[0022] Furthermore, in step S105, the wearing duration... and effective wearing time They can be distinguished as follows: ; in, This is an indicator function that takes the value 1 when the condition is true and 0 otherwise. The sampling time interval; For the first Contact confidence at each sampling time; For the first Effective wear-gating function for each sampling time; For the first Effective wear quality index at each sampling time; To preset the effective wearability quality index threshold; For the first Results of stability assessment of the effective wear quality index time window at each sampling time.

[0023] Furthermore, in step S105, based on the contact confidence level... Contact stability characteristics Effective wearable gating function Pressure effectiveness parameters Posture / motion matching parameters Effective Wearing Quality Index and effective wear quality index Time window stability assessment results Identify the wearing status; the effective wear quality index Time window stability assessment results According to the effective wear quality index Within the preset time window The duration of sustained compliance, the degree of volatility, and the downward trend must be determined; When contact stability characteristics When the preset requirements are met, the contact stability characteristics are set. The confidence level is 1 if it is not equal to 0 otherwise; when the confidence level is reached. Reaching the preset contact confidence threshold And contact stability characteristics When the preset requirements are met, enable the effective wear gating function. The effective wear quality index is equal to 1, otherwise it is equal to 0; Within the preset time window The wearable quality index consistently meets the standards and its fluctuation is less than the preset effective wearable quality index threshold. At that time, the effective wearable quality index Time window stability assessment results It equals 1, otherwise it equals 0; When contact confidence level <Preset contact confidence threshold> When the device is in use, it is identified as not being worn; when contact occurs, the confidence level is [not specified]. ≥Preset contact confidence threshold However, contact stability characteristics When the wearable contact is insufficient, it is identified as a wearable contact state; when the effective wearable gating function is active... But pressure effectiveness parameters When the preset pressure effectiveness conditions are not met, or when insufficient pressure, pressure deviation, or local high pressure occurs, it is identified as an abnormal pressure application state; when the effective gating function is applied... Pressure effectiveness parameters Meets preset pressure effectiveness conditions and attitude / motion matching parameters Meets preset posture / motion matching conditions and has an effective wear quality index. ≥Preset effective wearability quality index threshold And the effective wear quality index Time window stability assessment results When =1, it is identified as a valid wearing state.

[0024] Preferably, in step S105, the prompt information includes at least one of wear contact prompt, pressure action prompt, posture / movement abnormality prompt, and effective wear prompt, and is output through at least one of local display, audio-visual prompt, vibration prompt, mobile terminal prompt, and remote recording display.

[0025] Furthermore, the wear contact prompt is used to indicate states of not wearing, insufficient contact, unstable fit, or loose orthodontic device; the pressure application prompt is used to indicate states of insufficient pressure in the target area, displacement of the pressure application area, excessive local pressure, or pressure distribution that does not conform to the delivery calibration benchmark; the posture / movement abnormality prompt is used to indicate states of the patient's current posture deviating from the preset range, abnormal movement state, or abnormal fluctuations in contact-related data, pressure-related data, and posture / movement-related data within a preset time window; and the effective wear prompt is used to indicate that the current wear state conforms to the effective wear conditions corresponding to the delivery calibration benchmark.

[0026] Furthermore, the prompting information can be output through at least one of local display information, audio-visual prompting information, vibration prompting information, mobile terminal prompting information, and remote recording information to prompt patients to adjust their wearing status, remind caregivers to pay attention to abnormal situations, and generate monitoring information for clinical follow-up assessment reference.

[0027] An effective wearing quality assessment device for a scoliosis orthosis, which applies the effective wearing quality assessment method for a scoliosis orthosis as described above, is installed on or used in conjunction with the orthosis body, and is used to continuously monitor, statistically analyze and provide prompts on the wearing contact state, pressure state, posture / movement state and effective wearing quality during the wearing of the orthosis, including a monitoring host and a data acquisition module. The monitoring host includes a data processing module, a storage module, a communication module, a result output module, and a power supply module. The data processing module is electrically connected to the data acquisition module, the storage module, the communication module, and the result output module, respectively. The power supply module provides power to the data acquisition module, the data processing module, the storage module, the communication module, and the result output module, respectively. The data acquisition module includes a pressure acquisition unit, a posture / motion acquisition unit, and a contact-related acquisition unit. The pressure acquisition unit is used to acquire pressure-related data of the orthosis body within the target orthotic area. The posture / motion acquisition unit is used to acquire at least one of the following information during the patient's wearing of the orthosis: trunk posture, posture change trend, and motion state. The contact-related acquisition unit is used to acquire at least the temperature change information between the orthosis body and the human body, and can also supplementarily acquire at least one of the following information: fit state, proximity state, and contact state between the orthosis body and the human body.

[0028] Preferably, the sensing signals output by the data acquisition module are processed by the data processing module through signal conditioning, preprocessing, and feature extraction to form contact-related data, pressure-related data, and attitude / motion-related data; the data processing module calculates the contact confidence level based on the contact-related data. And based on the contact confidence level The contact stability characteristics are obtained by observing changes within a preset time window. Then, based on the contact confidence level... and contact stability characteristics Constructing an effective wearable gating function To determine whether a stable fit is formed between the orthosis and the human body; in the effective wear gating function When preset conditions are met, the data processing module calls the delivery benchmark stored in the storage module. And identify the patient's current posture or movement status based on posture / motor related data. The data processing module also considers the current posture or motion state. From delivery benchmark The corresponding state baseline is called in the middle. And compare the pressure-related data with the corresponding state baseline. Comparison to obtain pressure effectiveness parameters ; The data processing module is also used to perform effective wear gating function. Pressure effectiveness parameters Posture / motion matching parameters and time window stability parameters Calculate the effective wear quality index And based on the effective wear quality index and the results of the stability assessment of its time window Statistics on wearing time and effective wearing time The system generates status recognition results and prompt information, which are then stored, sent, or output by the storage module, communication module, and / or result output module.

[0029] Preferably, the data processing module includes a microcontroller and a signal conditioning circuit. The signal conditioning circuit is connected between the data acquisition module and the microcontroller and is used to filter, amplify, denoise, perform analog-to-digital conversion, and / or time synchronization processing on the sensor signal output by the data acquisition module. The microcontroller is configured to perform wear contact determination processing, reference call and status recognition processing, pressure effectiveness evaluation processing, effective wear quality assessment processing, duration statistics processing, and status recognition and prompt processing.

[0030] Preferably, the storage module is used to store raw sensing data, contact-related data, pressure-related data, attitude / motion-related data, and delivery calibration references. Corresponding state references under different postures / motion states Contact confidence Contact stability characteristics Effective wearable gating function Pressure effectiveness parameters Posture / motion matching parameters Time window stability parameters Effective Wearing Quality Index Time window stability assessment results Wearing time Effective wearing time At least one of the following: status recognition result, prompt information and its corresponding timestamp information.

[0031] Furthermore, the storage module is also used to store individualized configuration parameters, including target orthopedic region information, target pressure range, allowable pressure variation range under different postures / motion states, target posture range, and contact confidence threshold. Pressure effectiveness threshold, effective wear quality index threshold At least one of the following: time window length and prompting strategy.

[0032] Preferably, the communication module is used to transmit raw sensor data and contact confidence levels. Contact stability characteristics Effective wearable gating function Pressure effectiveness parameters Posture / motion matching parameters Effective Wearing Quality Index Wearing time Effective wearing time At least one of the following: status recognition results and prompt information, is sent to at least one of the user terminal, guardian terminal, doctor terminal, or remote monitoring platform.

[0033] Preferably, the result output module is used to output local prompt information and / or monitoring result information based on the state recognition result, including at least one of a display screen, indicator light, buzzer, and vibration prompter set on the monitoring host or orthosis body; the local prompt information and / or monitoring result information includes at least one of wearing contact prompt, pressure action prompt, posture / movement abnormality prompt, effective wearing prompt, wearing time statistics result, and effective wearing time statistics result.

[0034] Preferably, the power supply module includes at least one of a battery, a power management circuit, a charging interface, and a voltage regulator circuit, for providing operating power to the data acquisition module, the data processing module, the storage module, the communication module, and the result output module, and for performing low-power management on at least one module.

[0035] Preferably, the pressure acquisition unit is located in at least one of the thoracic convex side orthopedic area, lumbar orthopedic area, and other target orthopedic areas of the orthosis body, for obtaining at least one of pressure value, pressure distribution, pressure change trend, and pressure application state information; the posture / motion acquisition unit is located in at least one of the back support area, trunk posture characterization area, and inside the monitoring host of the orthosis body, for obtaining at least one of trunk posture angle, acceleration, angular velocity, posture change trend, and motion state information; the contact-related acquisition unit is located in at least one of the inner contact area, the area prone to local suspension, and the area prone to loosening of the orthosis body, for obtaining contact confidence information. and contact stability characteristics The calculation provides input information.

[0036] The beneficial effects of this invention are: 1) Layered determination of wearing status to improve the accuracy of effective wearing identification: This invention establishes a layered determination logic of "contact confidence - contact stability - effective wearing gating - effective wearing quality index". First, contact confidence is calculated through contact-related data. Then, contact stability is determined by combining the continuous achievement time, fluctuation degree and contact interruption number within a preset time window, and an effective wearing gating function is constructed based on this. This can distinguish different states such as not wearing, insufficient wearing contact and stable fit, avoiding the problem of judging whether the patient is wearing the garment effectively based on a single pressure value or a single wearing time. 2) Introducing a delivery calibration benchmark to achieve individualized wear quality evaluation: This invention uses the effective wear status confirmed by the doctor or orthodontist at the time of the patient's first trial or orthodontic delivery as the delivery calibration benchmark. The contact status, pressure status, posture status, target pressure area, and individualized threshold parameters at the time of delivery are transformed into storable, retrievable, and comparable data benchmarks. During the patient's daily wear, the system can compare the real-time monitoring data with the delivery calibration benchmark to evaluate whether the patient's current wear status continues to meet the effective wear requirements confirmed at the time of delivery. 3) Combining posture / movement status for sub-state pressure evaluation to reduce pressure misjudgment: This invention identifies the patient's current state (standing, sitting, lying, walking, bending, turning, or abnormal activity) through posture / movement-related data, and calls the corresponding state benchmark according to the current posture or movement state to perform sub-state evaluation of pressure-related data; thereby, it can determine whether the pressure in the target area still meets the delivery calibration requirements under the corresponding posture or movement state, avoiding misjudging pressure fluctuations during normal activities as abnormal, and also avoiding misjudging pressure deviation, insufficient pressure, or local high pressure as normal wear; 4) Statistical analysis of wearing time and effective wearing time to improve the value of wearing compliance assessment: This invention separately calculates wearing time and effective wearing time. Wearing time is used to characterize the cumulative time for the orthosis to form a wearing contact relationship with the human body, while effective wearing time is used to characterize the cumulative time under the conditions of stable fit, compliance with delivery calibration benchmarks, satisfactory pressure application, and time window stability. Compared with the method of only calculating the total wearing time, this invention can more objectively reflect the patient's daily wearing quality and wearing compliance, providing data basis for patient wearing adjustments, guardian reminders, and doctor follow-up assessments. 5) Concise and easy-to-understand prompts for patients and clinical management: This invention categorizes prompts into wear contact prompts, pressure prompts, posture / movement abnormality prompts, and effective wear prompts, covering common states such as not wearing, insufficient contact, insufficient pressure, pressure deviation, local high pressure, abnormal posture, abnormal fluctuations, and effective wear; output through local display, audio-visual prompts, vibration prompts, mobile terminal prompts, or remote recording, which helps patients adjust their wear status in a timely manner and also facilitates monitoring personnel and doctors in understanding abnormal wear situations outside the hospital; 6) Modular hardware structure, adaptable to different orthoses and monitoring needs: The device of this invention adopts a modular structure combining a monitoring host and a data acquisition module. The data acquisition module includes a contact-related acquisition unit, a pressure acquisition unit, and a posture / motion acquisition unit. The monitoring host includes a data processing module, a storage module, a communication module, a result output module, and a power supply module. Each module can be configured according to the orthodontic structure, patient body type, target orthodontic area, and clinical usage needs. It can be integrated into conventional scoliosis orthoses or 3D printed orthoses, or used as an external monitoring device, with good compatibility and scalability.

[0037] The features and advantages of the present invention will be described in detail through embodiments and in conjunction with the accompanying drawings. Attached Figure Description

[0038] Figure 1 This is a flowchart illustrating the effective wearing quality assessment method for scoliosis orthotics; Figure 2This is a structural block diagram of a device for assessing the effective wearing quality of scoliosis orthotics. Figure 3 It is a logical relationship diagram between contact confidence, contact stability, effective wear gating, delivery calibration benchmark, posture / motion state recognition, pressure effectiveness evaluation and effective wear quality evaluation; Figure 4 This is a schematic diagram illustrating status recognition, wearing duration, effective wearing duration, prompt output, and result recording and uploading. Figure 5 This is a schematic diagram of the installation layout of an effective wear quality assessment device for scoliosis orthotics.

[0039] In the diagram: 100 - Orthopedic body, 200 - Monitoring host, 210 - Data processing module, 220 - Storage module, 230 - Communication module, 240 - Result output module, 250 - Power supply module, 300 - Data acquisition module, 310 - Pressure acquisition unit, 320 - Posture / motion acquisition unit, 330 - Contact-related acquisition unit, 400 - Strap. Detailed Implementation

[0040] In this invention, the effective wearability quality assessment is not a simple weighted summation of values ​​collected from multiple sensors, nor is it based solely on a single pressure threshold, posture threshold, or wearing time for status judgment. Instead, it is based first on contact confidence. and its contact stability characteristics within a preset time window Establish effective wearability gating conditions; when the effective wearability gating conditions are met, invoke the delivery calibration benchmark. It identifies the current posture or motion state based on posture / motion-related data. Then, based on the current posture or motion state Call the corresponding state baseline The pressure-related data are used to evaluate the pressure effectiveness under different conditions and to calculate the pressure effectiveness parameters. Then, combined with attitude / motion matching parameters and time window stability parameters Calculate the effective wear quality index .

[0041] The effective wearable quality index described in this invention Used to characterize the patient's current wear status relative to the delivery calibration baseline The degree of retention is not directly equivalent to the clinical orthodontic efficacy; therefore, this invention can distinguish and identify states such as not wearing, insufficient wearing contact, abnormal pressure, abnormal posture / movement, and effective wearing, and assign wearing time as the standard. and effective wearing time The statistics provide a basis.

[0042] Example 1: Implementation of the monitoring method: This embodiment provides a method for evaluating the effective wearing quality of a scoliosis orthosis, which can be applied to the orthosis body 100, a monitoring terminal connected to the scoliosis orthosis, or a mobile terminal or doctor's terminal system that communicates with it. It mainly includes data acquisition, wearing contact determination, delivery calibration reference call and posture / movement state recognition, pressure effectiveness evaluation, effective wearing quality assessment, duration statistics, state recognition and result output.

[0043] like Figure 1 , Figure 3 and Figure 4 As shown, the method for assessing the effective wearing quality of the scoliosis orthosis includes the following steps: S101. Collect contact-related data, pressure-related data, and posture / motion-related data: In this embodiment, a corresponding sensing unit is arranged in a preset area of ​​the orthotic body 100 to collect various types of state data during the wearing process in real time or intermittently, and to perform time synchronization, filtering and windowing processing on the collected data to form a time-series monitoring dataset. The contact-related data is used to reflect whether a contact or fit relationship is formed between the orthotic body 100 and the human body; in this embodiment, a temperature sensor is set in the inner fitting area of ​​the orthotic body 100, and the change trend of the inner surface temperature of the orthotic after contact with the human body is detected to characterize whether the current area is in a wearing contact state. The pressure-related data is used to reflect the pressure state of the orthotic body 100 in the target orthotic area. In this embodiment, a thin-film pressure sensor is set in the thoracic convex side orthotic area, the lumbar orthotic area or other target orthotic areas of the orthotic body 100 to obtain the pressure value, pressure change trend or pressure duration. In addition, a flexible pressure sensor or an array pressure sensor can also be used to obtain the pressure distribution state. The posture / motion related data is used to reflect the patient's posture changes or movement state during the process of wearing the orthosis; in this embodiment, a posture sensor is set in the orthosis body 100 or the monitoring host 200 to collect pitch angle, tilt angle, rotation angle, acceleration, angular velocity or posture change trend, which is used to identify that the patient is currently in at least one of the following states: standing, sitting, lying down, walking, bending over, turning around or abnormal activity. S102. Calculate the contact confidence level based on contact-related data. and obtain contact stability characteristics. : Based on the contact-related data collected in step S101, contact feature parameters are first extracted. Taking temperature data as an example, at least one of the following features can be extracted: temperature value, temperature rise amplitude, temperature change rate, and temperature stable range. Taking proximity detection data as an example, distance change features can be extracted. Taking contact switch data as an example, the on-time feature can be extracted. Based on this, the contact confidence level is calculated. The contact confidence Used to characterize the confidence level of the wearing contact relationship between the orthotic body 100 and the human body at the current moment or within the current sampling window; when the contact confidence level The preset contact confidence threshold was not reached. When the device is in use, it is identified as not being worn; when contact occurs, the confidence level is [not specified]. Reaching the preset contact confidence threshold At that time, further based on contact confidence The contact stability characteristics are obtained by observing changes within a preset time window. ; The contact stability feature Used to characterize the persistence and stability of the contact relationship between the orthodontic body 100 and the human body within a preset time window; when the contact stability characteristic If the preset conditions are not met, it is identified as a state of insufficient wear contact; when the contact stability characteristics are met... Construct an effective wearable gating function when preset conditions are met. And then proceed to the subsequent delivery calibration benchmark matching and stress effectiveness evaluation process; In this embodiment, contact confidence and contact stability characteristics It is not directly equivalent to meeting the effective wear quality standard, but rather serves as a preliminary gating condition for effective wear quality assessment, in order to avoid meaningless wear quality evaluations under conditions of no wear, unstable contact, or insufficient contact. S103, Invoke delivery calibration benchmark And identify the current posture or motion state. : In this embodiment, the calibration benchmark is delivered. This can be established during the patient's initial fitting or orthosis delivery. Specifically, after the doctor or orthotic technician confirms that the wearing position of the orthosis body 100, the tightness of the straps 400, the target pressure area, and the wearing posture meet the preset requirements, the baseline contact state, baseline pressure state, baseline posture state, target pressure area, target pressure range, allowable pressure variation range under different postures / movement states, and individualized threshold parameters are collected or set, and these are used as the delivery calibration benchmark. Stored in storage module 220; During the patient's daily wear, the system identifies the current posture or movement state based on posture / motion-related data. The posture or motion state Including at least one of standing, sitting, lying down, walking, bending over, turning, and abnormal activities; based on the identified current posture or movement state. The system is based on the delivery benchmark. The corresponding state baseline is called in the middle. ; S104. Calculate the pressure effectiveness parameters under the current posture or motion state. : When the effective wear gate function At that time, the system determines the current posture or motion state. Call the corresponding state baseline And compare the pressure-related data with the corresponding state baseline. By comparing the target pressure region, target pressure range, and allowable pressure fluctuation range, pressure effectiveness parameters are calculated. ; The pressure effectiveness parameters Whether pressure-related data, used to characterize the current posture or motion state, meets the delivery calibration benchmark. Corresponding state reference Requirements; when the pressure in the target area is lower than the corresponding state baseline. When the pressure falls within the target pressure range, it is identified as insufficient pressure; when the pressure application area deviates from the target pressure range, it is identified as pressure deviation; when the local pressure exceeds the preset safety threshold and continues for a preset time, it is identified as local high pressure; when the pressure effectiveness parameter... When the preset pressure effectiveness threshold is reached, it is determined that the pressure application state meets the effective wearing requirements of the current posture or movement state; When the pressure acquisition unit includes multiple pressure sampling points or an array of pressure sensors, the degree of pressure deviation can also be determined based on the proportion of pressure outside the target area. When the pressure acquisition unit is a single point or a small number of thin-film pressure sensors, the pressure deviation can be determined based on the pressure amplitude, pressure duration, pressure fluctuation degree, and the corresponding state reference within the target area. Calculation of the degree of deviation of pressure effectiveness parameters ; S105. Calculate the effective wear quality index. And perform duration statistics and output the results: The system uses the valid wear gating function Pressure effectiveness parameters Posture / motion matching parameters and time window stability parameters Calculate the effective wear quality index Among them, attitude / motion matching parameters Used to characterize whether the current posture or motion state conforms to the corresponding state benchmark. Allowable range of attitude or motion; time window stability parameters Parameters used to characterize pressure effectiveness and / or posture / motion matching parameters At least one of the following: the degree of sustained achievement of the target, the degree of fluctuation, and the downward trend within a preset time window; The effective wear quality index Used to characterize the patient's current wear status relative to the delivery calibration baseline The degree of preservation; when At that time, the system does not output a valid wearable quality index. Or the effective wear quality index Mark as invalid evaluation value; when And the effective wear quality index Reaching the preset effective wear quality index threshold And its time window stability judgment results When the time is right, it is recognized as a valid wearing status; The system is based on contact confidence. Effective wearable gating function Effective Wearing Quality Index Results of time window stability assessment Wearing time was counted separately. and effective wearing time Among them, wearing time Used to characterize the cumulative time of wear contact between the orthotic body 100 and the human body; effective wear time. This is used to characterize the cumulative time required to further satisfy the following conditions, based on the establishment of wear contact: stable fit, compliance with delivery calibration benchmarks, pressure effectiveness, posture / motion matching, and time window stability. Depending on the status, the system outputs corresponding prompts and / or monitoring results. For example, when it is identified as not wearing the orthosis or insufficient contact, the user is prompted to adjust the wearing position or re-secure the orthosis. When it is identified as an abnormal pressure condition, the user is prompted to check the tightness of the straps 400, the fit of the orthosis body 100, or contact a doctor. When it is identified as an abnormal posture / movement condition, the user is prompted to adjust their posture or reduce abnormal activities. When it is identified as an effective wearing condition, the wearing time is recorded. and effective wearing time ; The results can be displayed on a screen on the orthosis body 100 or the monitoring host 200, indicated by an indicator light, a buzzer, or a vibration, or transmitted wirelessly to a mobile app, patient terminal, guardian terminal, or doctor's platform.

[0044] Example 2: Implementation of the monitoring device: like Figure 2 As shown, this embodiment provides an effective wearing quality assessment device for a scoliosis orthosis, which can be installed on or used in conjunction with the orthosis body 100. It includes a monitoring host 200 and a data acquisition module 300. The monitoring host 200 includes a data processing module 210, a storage module 220, a communication module 230, a result output module 240, and a power supply module 250. The data acquisition module 300 is used to collect contact-related data, pressure-related data and posture / motion-related data of the orthodontic body 100 during the wearing process, including a pressure acquisition unit 310, a posture / motion acquisition unit 320 and a contact-related acquisition unit 330. The data processing module 210 is electrically connected to the data acquisition module 300 and includes a microcontroller and a signal conditioning circuit. The signal conditioning circuit is used to filter, amplify, denoise, perform analog-to-digital conversion, and / or time synchronization processing on the sensor signal output by the data acquisition module 300. The microcontroller is used to perform feature extraction, wear contact determination, delivery calibration benchmark retrieval, posture / motion state recognition, pressure effectiveness evaluation, effective wear quality assessment, duration statistics, and status prompt generation on the processed contact-related data, pressure-related data, and posture / motion-related data. The microcontroller is configured to call the corresponding program stored in the storage module 220 to implement the aforementioned processing. The storage module 220 is electrically connected to the data processing module 210 and is used to store raw sensing data, feature parameters, and delivery calibration benchmarks. Corresponding state references under different postures / motion states Contact confidence Contact stability characteristics Effective wearable gating function Pressure effectiveness parameters Posture / motion matching parameters Time window stability parameters Effective Wearing Quality Index Time window stability assessment results Wearing time Effective wearing time At least one of the following: status recognition result, prompt information, and corresponding timestamp information; The communication module 230 is electrically connected to the data processing module 210 and is used to process sensor data and contact confidence. Contact stability characteristics Effective wearable gating function Pressure effectiveness parameters Posture / motion matching parameters Effective Wearing Quality Index Wearing time Effective wearing time At least one of the following—status recognition results and prompt information—is sent to the user terminal, guardian terminal, doctor terminal, or remote monitoring platform; The result output module 240 is electrically connected to the data processing module 210 and is used to output at least one of the following: wear contact prompt, pressure action prompt, posture / movement abnormality prompt, effective wear prompt, wear duration statistics result, effective wear duration statistics result, and abnormal status prompt; The power supply module 250 provides operating power to the data acquisition module 300, data processing module 210, storage module 220, communication module 230 and result output module 240, and performs low-power management for at least one module.

[0045] Example 3: Preferred application method of the monitoring device: See Figure 5 The orthotic body 100 is worn on the outside of the torso of a scoliosis patient. The pressure acquisition unit 310 is set in the convex side of the thoracic orthotic area, the lumbar orthotic area or other target orthotic areas. The contact-related acquisition unit 330 is set in the part of the orthotic liner that is in easy contact with the skin. The posture / motion acquisition unit 320 is set in the upper part, middle part or monitoring host 200 of the orthotic body 100.

[0046] The contact-related data acquisition unit 330 uses a temperature sensor, the pressure acquisition unit 310 uses a thin-film pressure sensor, and the posture / motion acquisition unit 320 uses a posture sensor. When the patient wears the scoliosis orthosis daily, the data acquisition module 300 continuously acquires temperature data, pressure data, and posture / motion data. The system first calculates the contact confidence level based on the contact-related data. And based on contact confidence Contact stability characteristics are obtained by changing the time window. At contact confidence level and contact stability characteristics Construct an effective wearable gating function when all preset conditions are met. ; In effective wear gating function At that time, the system calls the delivery benchmark. It identifies the current posture or motion state based on the data collected by the posture / motion acquisition unit 320. Then, based on the current posture or motion state Call the corresponding state baseline The pressure data collected by the pressure acquisition unit 310 is compared with the corresponding state reference. Compare and calculate pressure effectiveness parameters And further calculate the effective wear quality index. .

[0047] Patients or their caregivers can view the daily wear duration via mobile device. Effective wearing time It records status changes and provides alerts; doctors can use this information to assess patient compliance, effective wearing quality, and trends of abnormal changes, and to provide a reference for follow-up evaluations and adjustments to the wearing plan.

[0048] The above embodiments are illustrative of the present invention and are not intended to limit the present invention. Any simple modifications to the present invention are within the scope of protection of the present invention.

Claims

1. A method for evaluating the effective wearing quality of a scoliosis orthosis, characterized in that, Includes the following steps: S101, Data Acquisition: Collect contact-related data, pressure-related data, and posture / motion-related data of the orthotic body (100) during the wearing process, and form a time-series monitoring dataset; S102. Wearing Contact Determination: Calculate the contact confidence level based on the contact-related data. and contact stability characteristics And construct an effective wearable gating function. ; S103, Baseline Call and Status Identification: Calling the Delivery Calibration Baseline And identify the current posture or motion state based on the posture / motion related data. ; S104, Pressure Effectiveness Evaluation: Based on the effective wear gating function When preset conditions are met, based on the current posture or motion state Call the corresponding state baseline Calculate pressure effectiveness parameters ; S105. Quality Assessment and Result Output: Based on the effective wear gating function Pressure effectiveness parameters Posture / motion matching parameters and time window stability parameters Calculate the effective wear quality index Statistics on wearing time and effective wearing time It will also output a prompt message.

2. The method for evaluating the effective wearing quality of a scoliosis orthosis as described in claim 1, characterized in that: In step S101, the contact-related data is used to characterize the contact or fit state between the orthotic body (100) and the human body, and is acquired at least by a temperature sensor, and may also be acquired by at least one of a contact switch, a proximity sensor, and a flexible fit sensor; the pressure-related data is used to characterize the pressure state of the orthotic body (100) in the target orthotic area, and is acquired at least by a thin-film pressure sensor, and may also be acquired by at least one of a flexible pressure sensor, a piezoresistive pressure sensor, a capacitive pressure sensor, a flexible array pressure sensor, a piezoelectric pressure sensor, and a fiber optic grating pressure sensor; the posture / motion-related data is used to characterize the posture changes or motion state of the patient during the wearing of the orthotic, and is acquired at least by a posture sensor, and may also be acquired by at least one of an inertial measurement unit, an accelerometer, a gyroscope, and a posture angle sensor.

3. The method for evaluating the effective wearing quality of a scoliosis orthosis as described in claim 1, characterized in that: In step S102, the contact confidence level Used to characterize the interaction between the orthotic body (100) and the human body at any time. The reliability of establishing a wearable contact relationship; the contact stability characteristics. Used to characterize contact confidence Within the preset time window The persistence and stability within, and based on contact confidence. Within the preset time window Continuous compliance time within degree of fluctuation and number of contact interruptions At least one of them is determined; When contact confidence level Reaching the preset contact confidence threshold And contact stability characteristics When preset requirements are met, the effective wear gate function is used. If the condition for stable fit is met, the device proceeds to the subsequent pressure effectiveness evaluation process; otherwise, the effective wear gating function is used. If the condition is deemed not to meet the requirements for stable fit and wearing, and no effective wearing quality evaluation is conducted, or the evaluation result is marked as invalid.

4. The method for evaluating the effective wearing quality of a scoliosis orthosis as described in claim 1, characterized in that: In step S103, the delivery calibration benchmark This data, collected or set to characterize the patient's orthotic wearing position, strap tightness, target pressure area, and wearing posture when they meet preset requirements, includes at least one of the following: reference contact state, reference pressure state, reference posture state, target pressure area, target pressure range, allowable pressure variation range under different postures / movement states, target posture range, allowable posture fluctuation range, and individualized threshold parameters; the posture or movement state... It includes at least one of standing, sitting, lying down, walking, bending over, turning around, and abnormal activities, and is determined based on at least one of posture angle, acceleration, angular velocity, rate of posture change, periodicity of motion, and duration of state.

5. The method for evaluating the effective wearing quality of a scoliosis orthosis as described in claim 1, characterized in that: In step S104, the corresponding state reference This includes at least one of the following: target pressure region, target pressure range, allowable pressure fluctuation range, target attitude range, and allowable attitude fluctuation range, corresponding to the posture or motion state; the pressure effectiveness parameter Used to characterize pressure-related data and corresponding state benchmarks under the current posture or motion state. The degree of matching; When the pressure within the target pressure region is lower than the corresponding state benchmark When the pressure falls within the target pressure range, it is determined to be insufficient pressure; when the pressure area deviates from the target pressure area or the proportion of pressure outside the target area exceeds the preset offset threshold, it is determined to be pressure deviation; when the local pressure exceeds the preset safety threshold and the duration reaches the preset time, it is determined to be local high pressure; when the pressure effectiveness parameter... When the preset pressure effectiveness threshold is reached, it is determined that the pressure application state meets the effective wearing requirements of the current posture or movement state.

6. The method for evaluating the effective wearing quality of a scoliosis orthosis as described in claim 5, characterized in that: In step S105, the attitude / motion matching parameters Used to characterize whether the current posture or motion state conforms to the corresponding state benchmark. The permissible range of attitude or motion is determined based on at least one of attitude angle deviation, motion state classification confidence level, attitude duration, and attitude fluctuation degree; the time window stability parameter Parameters used to characterize pressure effectiveness and / or posture / motion matching parameters Within the preset time window The effective wearability quality index is defined by at least one of the following: the degree of continuous compliance, the degree of fluctuation, and the downward trend. Used to characterize the patient's current wear status relative to the delivery calibration baseline The degree of retention; the wearing time The effective wearing time is used to characterize the cumulative time for the orthotic body (100) to form a wearing contact relationship with the human body. This is used to characterize the cumulative time required to further satisfy the following conditions on the basis of established wear contact: stable fit, compliance with delivery calibration, effectiveness of pressure in different states, and stability within a time window.

7. The method for evaluating the effective wearing quality of a scoliosis orthosis as described in claim 6, characterized in that: In step S105, based on the contact confidence level Contact stability characteristics Effective wearable gating function Pressure effectiveness parameters Posture / motion matching parameters Effective Wearing Quality Index and effective wear quality index Time window stability assessment results Identify the wearing status; the effective wear quality index Time window stability assessment results According to the effective wear quality index Within the preset time window The duration of sustained compliance, the degree of volatility, and the downward trend must be determined; When contact stability characteristics When the preset requirements are met, the contact stability characteristics are set. The confidence level is 1 if it is not equal to 0 otherwise; when the confidence level is reached. Reaching the preset contact confidence threshold And contact stability characteristics When the preset requirements are met, enable the effective wear gating function. The effective wear quality index is equal to 1, otherwise it is equal to 0; Within the preset time window The wearable quality index consistently meets the standards and its fluctuation is less than the preset effective wearable quality index threshold. At that time, the effective wearable quality index Time window stability assessment results It equals 1, otherwise it equals 0; When contact confidence level <Preset contact confidence threshold> When the device is in use, it is identified as not being worn; when contact occurs, the confidence level is [not specified]. ≥Preset contact confidence threshold However, contact stability characteristics When the wearable contact is insufficient, it is identified as a wearable contact state; when the effective wearable gating function is active... But pressure effectiveness parameters When the preset pressure effectiveness conditions are not met, or when insufficient pressure, pressure deviation, or local high pressure occurs, it is identified as an abnormal pressure application state; when the effective gating function is applied... Pressure effectiveness parameters Meets preset pressure effectiveness conditions and attitude / motion matching parameters Meets preset posture / motion matching conditions and has an effective wear quality index. ≥Preset effective wearability quality index threshold And the effective wear quality index Time window stability assessment results When =1, it is identified as a valid wearing state.

8. The method for evaluating the effective wearing quality of a scoliosis orthosis as described in claim 1, characterized in that: In step S105, the prompt information includes at least one of wear contact prompt, pressure action prompt, posture / movement abnormality prompt, and effective wear prompt, and is output through at least one of local display, audio-visual prompt, vibration prompt, mobile terminal prompt, and remote recording display.

9. A device for assessing the effective wearing quality of a scoliosis orthosis, characterized in that: The method for evaluating the effective wearing quality of a scoliosis orthosis as described in any one of claims 1 to 8 is installed on or used in conjunction with the orthosis body (100) to continuously monitor, statistically analyze, and provide prompts on the wearing contact state, pressure state, posture / movement state, and effective wearing quality during the wearing of the orthosis, including a monitoring host (200) and a data acquisition module (300). The monitoring host (200) includes a data processing module (210), a storage module (220), a communication module (230), a result output module (240), and a power supply module (250). The data processing module (210) is electrically connected to the data acquisition module (300), the storage module (220), the communication module (230), and the result output module (240), respectively. The power supply module (250) supplies power to the data acquisition module (300), the data processing module (210), the storage module (220), the communication module (230), and the result output module (240), respectively. The data acquisition module (300) includes a pressure acquisition unit (310), a posture / motion acquisition unit (320), and a contact-related acquisition unit (330). The pressure acquisition unit (310) is used to acquire pressure-related data of the orthotic body (100) in the target orthotic area. The posture / motion acquisition unit (320) is used to acquire at least one of the trunk posture, posture change trend, and motion state information during the patient's wearing of the orthotic. The contact-related acquisition unit (330) is used to acquire at least the temperature change information between the orthotic body (100) and the human body, and can also supplementarily acquire at least one of the fit state, proximity state, and contact state information between the orthotic body (100) and the human body.

10. The effective wearing quality assessment device for a scoliosis orthosis as described in claim 9, characterized in that: The pressure acquisition unit (310) is located in at least one of the thoracic convex side orthopedic area, the waist orthopedic area and other target orthopedic areas of the orthopedic body (100); the posture / motion acquisition unit (320) is located in at least one of the back support area, the trunk posture characterization area and the monitoring host (200) of the orthopedic body (100); the contact-related acquisition unit (330) is located in at least one of the inner contact area, the area prone to local suspension and the area prone to loosening of the orthopedic body (100).

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