Method, system, medium and equipment for monitoring orthopedic force of spine orthopedic surgery

Abstract

The invention provides a method, a system, a medium and equipment for monitoring orthopedic force of a spinal orthopedic surgery, and belongs to the technical field of medical instruments. The spine orthopedic system comprises an inner fixing rod and an outer fixing rod, the fixing structure and the locking structure are fixed to the inner fixing rod; the opening structure slides on the outer side wall of the inner fixing rod; the elastic structure is arranged on the outer side wall of the inner fixing rod in a sleeving mode, is located in an interval limited by the locking structure and the opening structure and drives the opening structure to move in the direction away from the locking structure; the standby bolt is used for connecting the opening structure and the inner fixing rod; the sensor module is located at any end or two ends of the elastic structure and used for measuring elastic force data of the elastic structure and motion data of the inner fixing rod; and the wireless communication module is used for transmitting the elastic force data and the motion data to an external receiver. The problems that in the prior art, when a spring fails, overall replacement is needed, and the correction state, the spring function and spring stress cannot be monitored in real time can be solved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a method, system, medium and device for monitoring the corrective force in spinal orthopedic surgery. Background Technology

[0002] Early-onset scoliosis (EOS) refers to spinal deformities diagnosed in children before the age of 10. Clinically, corrective surgery using growth-friendly spinal implants is necessary to control the spinal deformity while preserving the growth potential of the spine and thoracic cage. Existing growth-friendly spinal implants, such as those disclosed in patents CN117122400A and CN115670622A, can utilize a spring structure to actively and continuously elastically expand the growth rod within the body, thereby correcting coronal translational deformities of the spine. However, significant technical limitations still exist.

[0003] On the one hand, existing scoliosis correction devices rely on spring structures to achieve dynamic correction. However, springs are prone to fatigue failure, and the spring device needs to be replaced after failure, which not only increases the pain and risk of secondary surgery for patients, but also significantly increases medical costs. On the other hand, existing devices lack the ability to monitor and adjust the spring status and corrective force in real time. They cannot accurately monitor the functional status of the spring in real time, nor can they dynamically adjust the correction parameters according to the growth of children's bones. This can easily lead to undercorrection or overcorrection, which can cause complications. At the same time, the data from uncalibrated single sensors is not reliable enough, making it difficult to accurately judge the spinal correction status and failing to provide accurate basis for clinical treatment. Summary of the Invention

[0004] The purpose of this application is to provide a method, system, medium, and device for monitoring the corrective force in spinal orthopedic surgery, in order to solve at least one of the above-mentioned technical problems.

[0005] In a first aspect, this application provides a spinal orthopedic system, the system comprising: Internal fixation rod; The fixing structure and locking structure are fixed to the internal fixing rod; A spreading structure that slides on the outer wall of the inner fixing rod; An elastic structure fitted on the outer wall of the inner fixing rod, the elastic structure being within the range defined by the locking structure and the spreading structure, and driving the spreading structure to move away from the locking structure; Spare bolts for connecting the expansion structure and the internal fixing rod; Sensor modules located at any one or both ends of the elastic structure are used to measure the elastic force data of the elastic structure and the motion data of the internal fixing rod; A wireless communication module is used to transmit the elasticity data and the motion data to an external receiver.

[0006] Optionally, the sensor module includes a first sensor module and a second sensor module; The first sensor module is located between the first end of the elastic structure and the locking structure, and the second sensor module is located between the second end of the elastic structure and the spreading structure.

[0007] Optionally, the system further includes: A pressure correction fixture includes a clamp head and a clamp body. Two clamping contact parts of the clamp head abut against the locking structure and the fixing structure, respectively. The force-bearing part of the clamp body is provided with a resistance strain gauge. When the clamping space of the clamp head changes, the magnitude of the force sensed by the resistance strain gauge changes with the change in the clamping space of the clamp head. A microcontroller is used to extract the force data measured by the resistance strain gauge and correct the elastic force data.

[0008] Optionally, the system further includes: A pressure display module is integrated into the clamp body or connected separately to the clamp body via a wire.

[0009] A second aspect of this application provides a method for monitoring the corrective force during spinal orthopedic surgery, applied to the spinal orthopedic system described in any embodiment of this application, comprising: Acquire the first elastic force data and first motion data at the first position, and the second elastic force data and second motion data at the second position, collected by the sensor module; The child's current activity status is identified based on the first and second motion data; When the current activity state is a quiet state, the trend of change in elasticity and usage time is obtained by combining the child's growth data and spinal deformity change data; Elastic force calibration data is calculated based on the first elastic force data and the second elastic force data; The elasticity calibration data and the trend of change are compared to analyze whether the spinal correction and elastic structure function are in a normal state.

[0010] Optionally, calculating the elasticity calibration data based on the first elasticity data and the second elasticity data includes: The elastic force transmission loss rate of the elastic structure is calculated based on the first elastic force data and the second elastic force data. Based on the elastic transmission loss rate and the usage time of the spinal orthopedic system, analyze whether the corresponding elastic structure is normal. When the elastic structure is in a normal state, elastic force calibration data is calculated based on the first elastic force data and the second elastic force data.

[0011] Optionally, the step of analyzing whether the elastic structure is normal based on the elastic transmission loss rate and the usage time of the spinal orthopedic system includes: obtaining a loss rate threshold η0 that matches the usage time, and analyzing whether the corresponding elastic structure is normal based on the magnitude between the elastic transmission loss rate and the loss rate threshold. The elastic force transmission loss rate η is calculated according to the formula η=(F1-F2) / F1×100%, and the elastic force calibration data F0 is calculated according to the formula F0=F2×[1+(η0-η) / 100], where F1 is the first elastic force data and F2 is the second elastic force data.

[0012] Optionally, identifying the child's current activity state based on the first and second motion data includes: Calculate the first correlation between the first motion data and the second motion data; Based on the mapping relationship between the first correlation, the first motion data, the second motion data and the activity status, the child's current activity status is determined; The method further includes: When the current activity state is a quiet state, and the duration of the quiet state exceeds a first duration threshold, the elasticity calibration data and the change trend are compared to analyze whether the spinal correction and elastic structure function are in a normal state.

[0013] In a third aspect, this application provides a computer-readable storage medium storing executable instructions that, when executed by a processor, cause the processor to perform the method described in any embodiment of this application.

[0014] In a fourth aspect, this application provides an electronic device comprising: one or more processors; and a memory for storing one or more programs, which, when executed by the one or more processors, cause the one or more processors to perform the method as described in any embodiment of this application.

[0015] The method, system, medium, and equipment for monitoring the corrective force in spinal orthopedic surgery disclosed in this application feature an elastic structure that provides continuously adaptable corrective force to meet the growth needs of children; a sensor module and a wireless communication module enable visualized monitoring of the corrective force and spinal activity, facilitating accurate assessment by doctors; and a spare bolt that can be quickly locked in case of elastic structure failure, significantly reducing the risk and cost of secondary surgery. This solves the problems in existing technologies where spring failure requires complete replacement, and the inability to monitor the corrective status, spring function, and spring force in real time. Attached Figure Description

[0016] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly described below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation on the scope of this application.

[0017] Figure 1 This is a schematic diagram of the overall structure of a spinal orthopedic system in one embodiment; Figure 2 This is a schematic diagram of the overall structure of the spinal orthopedic system in another embodiment; Figure 3 This is a partial structural diagram of a spinal orthopedic system including a sensor module in one embodiment; Figure 4 This is a schematic diagram of a clamping structure including a resistance strain gauge in one embodiment; Figure 5 This is a flowchart illustrating a method for monitoring the corrective force during spinal orthopedic surgery in one embodiment. Figure 6 This is a schematic diagram of a process for calculating elasticity calibration data based on the first elasticity data and the second elasticity data in one embodiment. Figure 7 This is a schematic diagram of the structure of an electronic device in one embodiment.

[0018] In the diagram, 1. Internal fixing rod; 2. Fixing structure; 3. Locking structure; 4. Elastic structure; 5. Spreading structure; 6. Spare bolt; 7. Sensor module; 8. Pressure correction fixture; 51. Connecting structure; 52. Moving rod; 53. Limiting structure; 81. Clamp; 82. Clamp body; 83. Resistance strain gauge; 84. Pressure display module; 811. First clamping contact part; 812. Second clamping contact part. Detailed Implementation

[0019] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of this application.

[0020] All terms used in this application (including technical and scientific terms) have the meanings commonly understood by those skilled in the art, unless otherwise defined. It should be noted that the terms used herein should be interpreted in a manner consistent with the context of this specification, and not in an idealized or overly rigid way.

[0021] For example, the terms "first," "second," etc., used in this application may be used herein to describe various elements, but these elements are not limited by these terms. These terms are only used to distinguish the first element from another element.

[0022] For example, the terms "comprising" or "including" used in this application indicate the presence of features, steps, operations and / or components, but do not exclude the presence or addition of one or more other features, steps, operations or components.

[0023] This application provides a spinal orthopedic system, combined with Figures 1 to 3 As shown, the system includes: an internal fixation rod 1, a fixing structure 2 and a locking structure 3 fixed to the internal fixation rod 1, a spreading structure 5 sliding on the outer side wall of the internal fixation rod 1, an elastic structure 4 sleeved on the outer side wall of the internal fixation rod, a spare bolt 6 for connecting the spreading structure 5 and the internal fixation rod 1, a sensor module 7 located at any one or both ends of the elastic structure, and a wireless communication module (not shown in the figure).

[0024] The elastic structure 4 is located within the area defined by the locking structure 3 and the spreading structure 5, and drives the spreading structure 5 to move away from the locking structure 3; the sensor module 7 is used to measure the elastic force data of the elastic structure 4 and the motion data of the inner fixing rod 1; the wireless communication module is used to transmit the elastic force data and the motion data to an external receiver.

[0025] Specifically, the fixing structure 2 is separate from the inner fixing rod 1 and is fixed to the side wall of the inner fixing rod 1 by friction; the locking structure 3 is separate from the inner fixing rod 1 and is fixed to the side wall of the inner fixing rod 1 by friction; the spreading structure 5 slides along a predetermined track on the outer side wall of the inner fixing rod 1; the elastic structure 4 is sleeved on the outer side wall of the inner fixing rod 1, located in the direction away from the fixing structure 2 of the locking structure 3, one end of the elastic structure 4 (through a sensor module) abuts against the side wall of the locking structure 3, and the other end (through a sensor module) abuts against the side wall of the spreading structure 5, driving the spreading structure to move away from the locking structure 3; the spare bolt 6 is threadedly connected to the spreading structure, and the spreading structure can be fixed to the side wall of the inner fixing rod 1 by friction.

[0026] The internal fixation rod 1 is a long, cylindrical structure, the length of which can be adjusted according to the needs of the child's spinal segments. The fixation structure 2 can be a pedicle screw assembly. Preferably, two or more sets of fixation structures 2 are provided, each set of fixation structures 2 is installed on the internal fixation rod 1 to improve the stability of the internal fixation rod 1 installation. The fixation structure 2 can correct scoliosis in the apical vertebral region, restore coronal displacement to normal, and perform fixation and fusion.

[0027] The elastic structure 4 is a linear compression spring. In use, the linear compression spring is first compressed, and then the spreading structure is installed on the inner fixing rod 1. At this time, the linear compression spring will generate a force to both sides in order to restore its original shape. The locking structure 3 on one side of the linear compression spring remains stationary, while the spreading structure 5 on the other side of the linear compression spring slides on the inner fixing rod 1. This causes the outward force of the linear compression spring to act on the spreading structure 5, driving the spreading structure to move away from the locking structure 3.

[0028] When the elastic force provided by the elastic structure 4 cancels out the tension of the patient's spine, causing the elastic structure 4 to be unable to push the expansion structure to move, a second surgery is performed. The spare bolt 6 is used to fix the expansion structure to the side wall of the internal fixation rod 1, so that the self-expanding convertible growth-friendly spinal orthopedic system in the body is transformed into an ordinary growth rod to continue to support the patient's spine.

[0029] like Figure 1 and Figure 2 As shown, the spreading structure 5 includes a connecting structure 51, a moving rod 52, and a limiting structure 53; the limiting structure 53 is separate from the moving rod 52 and is fixed to the side wall of the moving rod 52 by friction; one end of the connecting structure 51 is slidably connected to the inner fixing rod 1, and the other end is separate from the moving rod 52 and is fixed to the side wall of the moving rod 52 by friction.

[0030] Preferably, two or more sets of limiting structures 53 are provided, all of which are installed on the movable rod 52 to improve the stability of the movable rod 52 installation. The limiting structures 53 can also correct scoliosis in the apical vertebral region, restore coronal displacement to normal, and perform fixation and fusion.

[0031] One end of the elastic structure 4 (via a sensor module) rests against the side wall of the locking structure 3, and the other end (via a sensor module) rests against the side wall of the connecting structure 51; the elastic structure 4 pushes the connecting structure 51 to move away from the locking structure 3 on the inner fixing rod 1, thereby pushing the moving rod 52 and the limiting structure 53 to move.

[0032] The spring length is measured by X-ray, and the deformation *x* of the spring from its measured length to its initial length is calculated. This deformation *x* is then substituted into the formula for calculating the spring force *F*: *F* = *k* × *x*, where *k* is the elastic coefficient and *x* is the deformation. The remaining spring force is calculated. If the remaining spring force is insufficient, a secondary surgery is performed promptly. A spare bolt 6 is installed, and the expansion structure is fixed to the side wall of the internal fixation rod 1. At this point, the self-expanding, convertible, growth-friendly spinal orthopedic system transforms into a regular growth rod, continuing to support the patient's spine. Furthermore, the spring force data can be acquired through the sensor module 7 to detect any decrease in spring force and, based on the measurement results, to initiate a secondary surgery as needed.

[0033] The method of using this invention is as follows: S1, implant the fixing bolts on the fixing structure 2 and the fixing bolts on the limiting structure 53 into the child's spine; S2, install the locking structure 3 into the appropriate position of the internal fixation rod 1; S3, sequentially put the elastic structure 4 and the connecting structure 51 onto the internal fixation rod 1; S4, lock the positional relationship between the internal fixation rod 1 and the connecting structure 51; S5, lock the positional relationship between the moving rod 52 and the connecting structure 51; S6, install the internal fixation rod 1 into the installation position on the fixing structure 2; install the moving rod 52 into the installation position on the limiting structure 53; S7, loosen the lock between the internal fixation rod 1 and the connecting structure 51. At this time, the elastic structure 4 pushes the connecting structure 51 to move away from the locking structure 3, that is, pushes the part of the spine connected to the internal fixation rod 1 away from the part of the spine connected to the moving rod 52, thereby achieving the therapeutic purpose; S8, regularly monitor the elasticity of the elastic structure 4, and promptly perform a secondary surgery to convert it into a regular growth rod to continue supporting the patient's spine.

[0034] Alternatively, if the elasticity of the elastic structure 4 fails and the patient still needs to use the self-expanding convertible growth-friendly spinal orthopedic system for treatment, the elastic structure 4 needs to be compressed again. In this case, the following steps can be taken for adjustment: S1, insert the spare bolt 6 into the expansion structure and tighten it, using friction to fix the expansion structure to the side wall of the internal fixation rod 1; S2, loosen the locking bolt on the locking structure 3 so that the locking structure 3 can move on the internal fixation rod 1; S3, push the locking structure 3 towards the expansion structure 5 to compress the elastic structure 4; S4, after compressing the elastic structure 4 to a suitable length, tighten the locking structure 3 to lock its position; S5, remove the spare bolt 6 to complete the adjustment operation.

[0035] Optionally, the sensor module 7 can be located at one or both ends of the elastic structure 4. That is, a sensor module 7 can be set at either end of the elastic structure, or a sensor module can be set at each end of the elastic structure. For example, one sensor module 7 abuts against one end of the locking structure 3 and the elastic structure 4; the other sensor module 7 abuts against the other end of the spreading structure 5 and the elastic structure 4.

[0036] Sensor module 7 integrates a pressure sensor and a motion sensor. The sensing surface of the pressure sensor is in direct contact with the end face of the elastic structure to measure the elastic force data of the elastic structure in real time. The motion sensor can be one or more of an accelerometer, gyroscope, displacement sensor or vibration sensor. The motion sensor can measure the motion data of the internal fixation rod in the child's body. This motion data can be, for example, acceleration data, vibration data, relative displacement data, angular velocity data, etc.

[0037] The sensor module can be fixed to one end of the elastic structure by welding or other methods without affecting the spring's extension and contraction stroke. The module surface is also treated with an insulating coating to avoid direct contact with human tissue.

[0038] The wireless communication module can be integrated into a suitable location on any component, such as the internal fixing rod. It can use wireless communication methods such as Bluetooth Low Energy chips and supports wireless communication with an external receiver. This wireless communication module is electrically connected to sensor module 7 and can receive elastic force data and motion data collected by each sensor module in real time, and send them in packets according to a preset communication frequency.

[0039] The spinal orthopedic system in this application features an elastic structure that provides continuously adapting corrective force to meet the growth needs of children; a sensor module and a wireless communication module enable visual monitoring of the corrective force and spinal activity, facilitating accurate assessment by doctors; and a spare bolt that can be quickly locked in case of elastic structure failure, significantly reducing the risk and cost of secondary surgery and solving the problems of existing technologies where spring failure requires complete replacement and the correction status cannot be monitored in real time.

[0040] In one embodiment, the sensor module includes a first sensor module and a second sensor module; the first sensor module is located between a first end of the elastic structure and the locking structure, and the second sensor module is located between a second end of the elastic structure and the spreading structure.

[0041] Specifically, the two are symmetrically distributed at both ends of the elastic structure, forming a "two-end clamping" monitoring layout.

[0042] The first sensor module is sandwiched between the first end of the elastic structure and the locking structure, with one end face of the sensor in contact with the end face of the locking structure and the other end face in direct contact with the end face of the first end of the elastic structure; the second sensor module is sandwiched between the second end of the elastic structure and the spreading structure, with one end face in direct contact with the end face of the second end of the elastic structure and the other end face in contact with the end face of the spreading structure.

[0043] This layout allows the two modules to simultaneously collect mechanical data from both ends of the elastic structure and motion data from the corresponding positions, providing a foundation for subsequent calculations of elastic force transmission loss and verification of data validity.

[0044] In one embodiment, such as Figure 1 , Figure 2 and Figure 4As shown, the system also includes a pressure correction fixture 8 and a microcontroller (not shown in the figure). The pressure correction fixture 8 includes a clamp 81 and a clamp body 82. The two clamping contact parts of the clamp abut against the locking structure and the fixing structure, respectively. The force-bearing part of the clamp body is provided with a resistance strain gauge 83. When the clamping space of the clamp changes, the force sensed by the resistance strain gauge 83 changes with the change in the clamping space of the clamp. The microcontroller is used to extract the force data measured by the resistance strain gauge to correct the elastic force data.

[0045] In this embodiment, the pressure correction clamp 8 is an external calibration tool used to mechanically calibrate the elasticity data collected by the sensor module after surgical implantation or postoperative follow-up. Its structure includes a clamp head 81 and a clamp body 82.

[0046] The clamp 81 can be a symmetrical V-shaped clamping structure, including two clamping contact parts (the first clamping contact part 811 and the second clamping contact part 812, respectively). The clamp body 82 is a rod-shaped structure with a built-in strain beam structure. A resistance strain gauge can be attached to the inner surface of the strain beam. When the clamping space of the clamp changes (i.e., the distance between the two contact parts decreases or increases), the strain beam undergoes bending deformation synchronously, and the resistance of the resistance strain gauge changes synchronously with the deformation (the resistance increases during tension and decreases during compression), thereby converting the mechanical force into a measurable electrical signal.

[0047] The core function of the pressure straightening fixture is to obtain a reference force value through the clamping and locking structure and the fixing structure. The specific connection method is as follows: During calibration, the first clamping contact portion 811 is aligned with one end face of the locking structure, and the second clamping contact portion 812 is aligned with one end face of the fixing structure. A clamping force is slowly applied to the clamp body 82 to open or tighten the clamp until the contact portion is in close contact with the locking and fixing structures. At this point, the inner fixing rod is under slight pressure, and the deformation of the elastic structure is temporarily fixed. During clamping, the elastic force of the elastic structure is transmitted to the clamp through the locking structure, causing the strain beam of the clamp body to deform under stress. The resistance strain gauge outputs a voltage signal proportional to the elastic force.

[0048] The microcontroller can communicate with both the resistance strain gauge 83 and the wireless communication module. Its core function is to correct the elastic force data from the sensor module based on the force data from the resistance strain gauge. The specific process is as follows: Reference force value acquisition: The microcontroller receives the voltage signal from the resistance strain gauge and converts it into the actual clamping force through a preset calibration curve (such as the curve obtained by calibration with a standard force source before leaving the factory).

[0049] Sensor data acquisition: Synchronously receive elastic force data measured by the first sensor module and the second sensor module.

[0050] Correction coefficient calculation: Calculate the deviation rate between the clamping force and each elastic force data, and automatically calculate the correction coefficient for each elastic force data based on the deviation rate. Write the coefficient into the storage unit of the sensor module so that the elastic force data output by the subsequent sensor can be automatically corrected according to the correction coefficient.

[0051] In one embodiment, such as Figure 1 and Figure 2 As shown, the system also includes a pressure display module 84, which is integrated on the clamp body 82 or separately connected to the clamp body 82 via a wire.

[0052] The pressure display module 84 is used to visualize the measurement data and calibration results of the pressure correction clamp in real time, allowing doctors to quickly determine the calibration status during surgery or follow-up examinations. The pressure display module can display the clamping force value, each elastic force data point, and motion data in real time. It can also further display the calculated deviation rate, correction coefficient, and correction status (such as calibration in progress, calibrated, fault, etc.). The pressure display module is equipped with operation keys for starting the calibration process, saving the correction coefficient, or re-measuring.

[0053] The pressure display module 84 can be either integrated or separate. The integrated pressure display module can be directly embedded into the handheld end of the clamp; the separate pressure display module is an independent display unit that is connected to the clamp via wires.

[0054] In one embodiment, a method for monitoring the corrective force during spinal orthopedic surgery is provided, which is applied to the spinal orthopedic system described in any embodiment of this application, such as... Figure 5 As shown, the method includes: Step 510: Acquire the first elastic force data and first motion data at the first position, and the second elastic force data and second motion data at the second position collected by the sensor module.

[0055] In this embodiment, the first position is the location of one end of the elastic structure in the spinal orthopedic system (such as the first end mentioned above); the second position is the location of the other end of the elastic structure in the spinal orthopedic system (such as the second end mentioned above). The first elastic force data and the first motion data are data collected by a sensor module (such as the first sensor module mentioned above) located at the first position, and the second elastic force data and the second motion data are data collected by a sensor module (second sensor module) located at the second position. These data can be the raw data collected by the sensor module, or the data after filtering or other preprocessing. Furthermore, they can also be the average data of a set of preprocessed data.

[0056] The electronic device can acquire first elastic force data, second elastic force data, first motion data, and second motion data in real time according to a preset acquisition frequency. For example, it can acquire data once per minute or once every 2 minutes / 5 minutes, or any suitable acquisition frequency. The first elastic force data and second elastic force data can be the elastic force exhibited at the corresponding ends of the elastic structure during compression or extension; the first motion data and second motion data are the activity states exhibited by the internal fixation rod of the spinal orthopedic system in the child as the child (spinal segment) moves, such as any one or more of acceleration data, angular velocity data, relative displacement data, vibration data, etc.

[0057] Step 520: Identify the child's current activity status based on the first motion data and the second motion data.

[0058] In this embodiment, the child's activity state refers to the comprehensive representation of the intensity, type, and coordination of spinal segments after the implantation of the spinal orthopedic system. Activity state can include various types such as a resting state, a mild activity state, and a vigorous activity state. A resting state typically includes situations with minimal spinal movement, such as sleeping or sitting still; a mild activity state includes situations with moderate spinal movement, such as contentment or changing sitting posture; and a vigorous activity state includes situations with a large range of movement, such as running, jumping, or bending over. The dynamic load on the spine and the stress fluctuation patterns of its elastic structure differ significantly under different activity states (e.g., a brief increase in corrective force during vigorous activity is normal, while abnormal fluctuations in corrective force in a resting state indicate risk). Therefore, activity state identification is a crucial prerequisite for avoiding misjudgment of the orthopedic state.

[0059] The electronic device can perform feature analysis based on the acquired first and second motion data to determine the child's current motion state. This current motion state can be one of the aforementioned quiet state, mild activity state, and vigorous activity state. The feature analysis may include one or more of the following: mean analysis, extreme value analysis, or variance calculation of the first and second motion data.

[0060] Specifically, the electronic device can continuously extract first motion data and second motion data collected over a period of time, form a first motion sequence based on the continuous first motion data collected over a period of time, and form a second motion sequence based on the continuous second motion data collected over a period of time. This period of time can be any suitable duration such as 5 minutes, 10 minutes, 20 minutes, 30 minutes, or 1 hour.

[0061] For the first and second motion data sequences, averaging can be performed to calculate the corresponding motion mean and variance, and the maximum value can be identified. Based on the motion mean, maximum value, and / or variance, the child's current motion state can be determined. For example, the electronic device can identify the numerical range of the motion mean and maximum value. When both are within the range corresponding to the quiet state, the current activity state can be determined to be a quiet state; when both are within the range corresponding to the mild activity state, and the variance of the data sequence is also within the variance range of the mild activity state, the current activity state is determined to be a mild activity state; if both are within the range corresponding to the vigorous activity state, and the variance is also within the variance range of the vigorous activity state, the current activity state is determined to be a vigorous activity state.

[0062] Step 530: When the current activity state is a quiet state, combine the child's growth data and spinal deformity change data to obtain the matching trend of elasticity and usage time.

[0063] In this embodiment, the child's growth data may include height, weight, sex, age / bone age, and height growth rate. Spinal deformity change data includes the degree of scoliosis monitored during or before surgery. The electronic device can be pre-set to show the change trend of the elasticity of the elastic structure over time when using the spinal orthopedic system, based on different growth and spinal deformity change data; this trend can be a corresponding trend graph.

[0064] For children to be monitored, growth data and spinal deformity change data are obtained to match the corresponding trends in elasticity and usage time.

[0065] Furthermore, the electronic device pre-collected various data on changes in elasticity of the elastic structure, children's growth data, and spinal deformity changes during the spinal orthopedic process, forming a corresponding sample dataset. Each sample dataset was labeled with the corresponding child's growth data and spinal deformity change data. A pre-defined elasticity fitting model was trained on this sample data to generate trends in elasticity changes under different growth and spinal deformity changes. For the child to be analyzed, this elasticity fitting model was used to fit the corresponding elasticity change trend by acquiring their growth and spinal deformity change data. This trend represents the change in elasticity of the elastic structure over time. This fitting model can be any suitable neural network model.

[0066] Electronic devices can periodically collect children's growth data and spinal deformity change data. By using the children's growth data and spinal deformity change data as input to the corresponding model, the trend of change of elasticity and usage time can be obtained, making the fitted trend more accurate.

[0067] Step 540: Calculate the elasticity calibration data based on the first elasticity data and the second elasticity data.

[0068] In this embodiment, the measured first and second elastic force data can be calibrated to obtain elastic force calibration data. The elastic force calibration data is the true elastic force value obtained after error correction of the two elastic force data, eliminating the effects of sensor drift, force transmission loss, etc., and serving as a core parameter for evaluating the correction status. By performing elastic force calibration, the data used for orthopedic analysis becomes more accurate.

[0069] Optionally, the elasticity calibration data can be the average of the first elasticity data and the second elasticity data, or it can be a value calculated based on the usage time of the spinal orthopedic system. Alternatively, it can be combined with the force data measured during the most recent use of the pressure correction clamp. Based on this force data and the two elasticity data measured at the corresponding time, the deviation rate of the two elasticity data can be calculated respectively. The first and second elasticity data are then corrected based on this deviation rate to obtain the elasticity calibration data. For example, the elasticity calibration data F0 can be obtained using the formula: F0=[F1 / (1-a1)+F1 / (1-a1)] / 2.

[0070] Where F1 represents the first elastic force data, F2 represents the second elastic force data, a1 represents the latest deviation rate of the first elastic force data, and a2 represents the latest deviation rate of the second elastic force data. For example, if the first elastic force data obtained from one measurement is 91.5, the second elastic force data is 95, and the force data measured by the pressure correction fixture is 92, then a1 = (91.5 - 92) / 92 × 100% ≈ -0.54%; a2 = (95 - 92) / 92 × 100% ≈ 3.3%. Based on a1 and a2, the corresponding elastic force calibration data can be calculated for the currently measured first elastic force data F1 and second elastic force data F2.

[0071] Step 550: When the elastic structure is in a normal state, compare the elasticity calibration data and the change trend to analyze whether the spinal correction and elastic structure function are in a normal state.

[0072] The calculated elasticity calibration data can be compared with a trend of change. Based on usage time, a baseline elasticity data corresponding to the current moment can be derived from this trend. The deviation between the calibration data and the baseline data is then compared to determine whether the spinal correction is functioning normally. For example, if the deviation exceeds a certain threshold, it indicates that the child's spinal correction may require adjustment, or that the spinal correction system itself needs modification. If the deviation does not exceed the threshold, the spinal correction is considered normal.

[0073] For example, assuming the current system has been used for 6 months, the F0 calculated in step 540 is 92.47. According to the trend information obtained in step 530, the corresponding elasticity benchmark data in the 6th month is 90±5. The 92.47 is within the deviation range, or the calculated deviation is (92.47-90) / 90×100%≈2.7%, which is less than the corresponding deviation threshold. Therefore, the spinal correction can be judged to be normal.

[0074] Furthermore, when the current activity state is a quiet state, and the duration of the quiet state exceeds a first duration threshold, the elasticity calibration data and the change trend are compared to analyze whether the spinal correction and elastic structure function are in a normal state.

[0075] The first duration threshold can be any preset, suitable duration, such as 10 minutes or 15 minutes. In a quiet state, the spine experiences stable stress, and the elasticity calibration data accurately reflects the corrective effect; therefore, a certain duration is required to ensure data stability.

[0076] In this embodiment, by acquiring the first motion data, second motion data, first elasticity data, and second elasticity data in real time, when the child is detected to be in a quiet state for the first time, the cumulative duration of the current quiet state is calculated. When the cumulative duration exceeds the first duration threshold, the corresponding elasticity calibration data is calculated based on the first elasticity data and second elasticity data measured in the subsequent quiet state. Based on the elasticity calibration data, it is determined whether the spinal correction is in a normal state.

[0077] The spinal orthopedic surgery force monitoring method in this application, by combining dual-sensor data from a hardware system with clinical characteristics, has the following technical effects: 1. Intelligent activity state recognition: Analyzing the child's current activity state through motion data and using elastic force data measured when the child is at rest for orthopedic analysis, avoiding the influence of the child's movement on elastic force data measured in a non-resting state, thus reducing the misjudgment rate of orthopedic analysis. 2. Precise monitoring of corrective force: By calculating elastic force calibration data, the influence of single sensor errors and force transmission losses is eliminated, providing reliable data for clinical assessment. 3. Dynamic adaptation to child growth: Based on the child's growth data and spinal deformity change data, personalized trend curves are retrieved, avoiding a "one-size-fits-all" assessment standard and improving the accuracy of orthopedic judgment. 4. Early warning of potential risks: By comparing elastic force calibration data and trend curves in real time, orthopedic abnormalities can be detected in a timely manner, allowing for timely intervention.

[0078] In one embodiment, such as Figure 6 As shown, the step of calculating the elasticity calibration data based on the first elasticity data and the second elasticity data includes: Step 610: Calculate the elastic force transmission loss rate of the elastic structure based on the first elastic force data and the second elastic force data.

[0079] Step 620: Analyze whether the elastic structure is normal based on the elastic transmission loss rate and the usage time of the spinal orthopedic system.

[0080] Step 630: When the elastic structure is in a normal state, calculate the elastic force calibration data based on the first elastic force data and the second elastic force data.

[0081] In this embodiment, the elastic force transmission loss rate η represents the proportion of the difference in elastic force between the two ends caused by factors such as material fatigue, contact surface friction, and component assembly gaps during the transmission of corrective force by the elastic structure, relative to the input elastic force. It is a core indicator for evaluating the stability of the mechanical performance of the elastic structure. The larger η is, the more severe the loss of the elastic structure. The usage time T of the spinal orthopedic system represents the cumulative time (unit: days) calculated from the date the system is surgically implanted into the human body. It is pre-stored by an external receiver or microcontroller and automatically updated (the initial date is entered at the time of implantation). When the elastic force transmission loss rate η ≤ the loss rate threshold η0 under the corresponding usage time T, and the elastic force output of the elastic structure can still meet the orthopedic requirements (i.e., the calibrated elastic force data is within the range of the preset trend curve), it indicates that the elastic structure is in a normal state and there is no risk of fatigue fracture or elastic failure.

[0082] The elastic force transmission loss rate can be the two latest deviation rates mentioned above, or it can be based on the two latest deviation rates measured above, combined with the time interval between the current time and the measurement time of the two latest deviation rates. The calculated value is t. For example, the elastic force transmission loss rate η1 of the first elastic force data is η1 = a1 × (1 + b × t). t), the elastic force transmission loss rate of the second elastic force data η2=a2×(1+b× t), b can be a coefficient set empirically. This time interval t reflects the time elapsed between the last time the latest deviation rate was measured and the time elapsed between the current measurement of the first and second elastic force data.

[0083] Specifically, a loss rate threshold η0 matching the usage duration is obtained, and the corresponding elastic structure is analyzed to determine whether it is normal based on the magnitude between the elastic force transmission loss rate and the loss rate threshold.

[0084] Electronic devices are preset with corresponding elastic force transmission loss rate thresholds for different usage durations. When the elastic force transmission loss rate exceeds this threshold, it indicates that the corresponding elastic force data measurement is inaccurate, and the elastic structure is abnormal, requiring timely updating or correction. For example, when the time interval... When the usage time is within 0 days to 1 month, the corresponding loss rate threshold is 1%. When the usage period is between 1 and 3 months, the corresponding loss rate threshold is 2%. When the usage period is between 3 and 6 months, the corresponding loss rate threshold is 5%.

[0085] In one embodiment, the elastic force transmission loss rate η is calculated according to the formula η=(F1-F2) / F1×100%, and the elastic force calibration data F0 is calculated according to the formula F0=F2×[1+(η0-η) / 100], where F1 is the first elastic force data and F2 is the second elastic force data.

[0086] Specifically, F1 can be the average of a set of pressure data collected by the first sensor module within the same time period, and F2 can be the average of a set of pressure data collected by the second sensor module within the same time period. By calculating the elastic force transmission loss rate and elastic force calibration data based on the collected average values, the accuracy of both calculations is improved.

[0087] By combining the elasticity transmission loss rate and service life, the problem of existing technologies being unable to quantify the fatigue level of elastic structures is solved, thereby enabling early warning of excessive loss and effectively reducing the occurrence of correction interruptions due to elastic failure.

[0088] In one embodiment, identifying the child's current activity state based on the first motion data and the second motion data includes: calculating a first correlation between the first motion data and the second motion data; and determining the child's current activity state based on the mapping relationship between the first correlation, the first motion data, the second motion data, and the activity state. In this embodiment, first motion data and second motion data collected over a period of time can be continuously extracted to form a first motion sequence and a second motion sequence, respectively. The mean of the two motion sequences is calculated, and a first correlation between the two is calculated based on the first and second motion sequences. This correlation can be calculated using the Pearson correlation coefficient formula. A higher correlation indicates a stronger synergy between the two motions, which in turn indicates higher accuracy in the measurement of the data.

[0089] Electronic devices have preset correlation ranges and motion data ranges for different activity states. By calculating the correlation of motion data and the corresponding range of the mean of motion data, the child's current activity state can be determined.

[0090] In one embodiment, the method further includes: when the child's current activity state is not quiet, identifying whether the elastic structure and sensor module are faulty based on the first elasticity data and the second elasticity data.

[0091] The resting state can be either the mild activity state or the vigorous activity state mentioned above, preferably the vigorous activity state. A first elastic force data sequence can be constructed from multiple first elastic force data measured in a non-resting state, and a second elastic force data sequence can be constructed from multiple second elastic force data. The first elastic force mean and first variance in the first elastic force data sequence are calculated, as are the second elastic force mean and second variance in the second elastic force data sequence. A second correlation degree is calculated based on the first and second elastic force data sequences. This second correlation degree can also be calculated using the Pearson correlation coefficient formula mentioned above.

[0092] Obtain the variance threshold and correlation threshold corresponding to the non-quiet state, and determine whether the elastic structure has a fault based on the correlation threshold, the first variance and / or the second variance.

[0093] If the correlation between the two data points is lower than a preset correlation threshold, it indicates low synergy between the elastic force data at the two locations. In this case, the elastic force data measured at one location may be inaccurate, or the elastic force data measured at both locations may be inaccurate, suggesting a possible malfunction in the sensor module. If the correlation exceeds the preset correlation threshold, the variance of the elastic force data is monitored to ensure it is within acceptable limits.

[0094] The variance threshold can be a numerical range. When both the first and second variances are within this range, it indicates that the elastic structure is normal. When it is less than the lower limit of the range or exceeds the upper limit, it indicates that the corresponding first and / or second elastic force data have not fluctuated as expected, which may indicate that the elastic structure is abnormal.

[0095] Furthermore, the aforementioned variance threshold and elastic force transmission loss rate can be combined to jointly determine whether the elastic structure is abnormal. For example, if the first variance and / or the second variance are not within the specified range, and the elastic force transmission loss rate exceeds the corresponding loss rate threshold, then the elastic structure is determined to be abnormal.

[0096] In one embodiment, a computer-readable storage medium is provided having executable instructions stored thereon, which, when executed by a processor, cause the processor to perform the steps in the above method embodiments.

[0097] In one embodiment, an electronic device is also provided, including one or more processors; and a memory storing one or more programs, wherein when the one or more programs are executed by the one or more processors, the one or more processors perform the steps in the above method embodiments.

[0098] In one embodiment, such as Figure 7 The diagram illustrates the structure of an electronic device used to implement an embodiment of this application. The electronic device includes a central processing unit (CPU) 701, which can perform various appropriate actions and processes based on a program stored in a read-only memory (ROM) 702 or a program loaded from a storage portion 708 into a random access memory (RAM) 703. The RAM 703 also stores various programs and data required for the operation of the electronic device. The CPU 701, ROM 702, and RAM 703 are interconnected via a bus 704. An input / output (I / O) interface 705 is also connected to the bus 704.

[0099] The following components are connected to the I / O interface 705: an input section 706 including a keyboard, mouse, etc.; an output section 707 including a cathode ray tube (CRT), liquid crystal display (LCD), etc., and speakers, etc.; a storage section 708 including a hard disk, etc.; and a communication section 709 including a network interface card such as a LAN card, modem, etc. The communication section 709 performs communication processing via a network such as the Internet. A drive 710 is also connected to the I / O interface 705 as needed. A removable medium 711, such as a disk, optical disk, magneto-optical disk, semiconductor memory, etc., is installed on the drive 710 as needed so that computer programs read from it can be installed into the storage section 708 as needed.

[0100] Specifically, according to embodiments of this application, the processes described above with reference to the flowcharts can be implemented as computer software programs. For example, embodiments of this application include a computer program product comprising a computer-readable medium carrying instructions that, in such embodiments, can be downloaded and installed from a network via communication section 709, and / or installed from removable medium 711. When the instructions are executed by central processing unit (CPU) 701, the various method steps described in this application are performed.

[0101] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application.

[0102] Furthermore, those skilled in the art will understand that although some embodiments herein include certain features included in other embodiments but not others, combinations of features from different embodiments are meant to be within the scope of this application and form different embodiments. For example, all the embodiments above can be used in any combination. The information disclosed in this background section is intended only to enhance the understanding of the general background of this application and should not be construed as an admission or in any way implying that such information constitutes prior art known to those skilled in the art.

Claims

1. A spinal orthopedic system, characterized in that, The system includes: Internal fixation rod; The fixing structure and locking structure are fixed to the internal fixing rod; A spreading structure that slides on the outer wall of the inner fixing rod; An elastic structure fitted on the outer wall of the inner fixing rod, the elastic structure being within the range defined by the locking structure and the spreading structure, and driving the spreading structure to move away from the locking structure; Spare bolts for connecting the expansion structure and the internal fixing rod; Sensor modules located at any one or both ends of the elastic structure are used to measure the elastic force data of the elastic structure and the motion data of the internal fixing rod; A wireless communication module is used to transmit the elasticity data and the motion data to an external receiver.

2. The spinal orthopedic system according to claim 1, characterized in that, The sensor module includes a first sensor module and a second sensor module; The first sensor module is located between the first end of the elastic structure and the locking structure, and the second sensor module is located between the second end of the elastic structure and the spreading structure.

3. The spinal orthopedic system according to any one of claims 1 or 2, characterized in that, The system also includes: A pressure correction fixture includes a clamp head and a clamp body. Two clamping contact parts of the clamp head abut against the locking structure and the fixing structure, respectively. The force-bearing part of the clamp body is provided with a resistance strain gauge. When the clamping space of the clamp head changes, the magnitude of the force sensed by the resistance strain gauge changes with the change in the clamping space of the clamp head. A microcontroller is used to extract the force data measured by the resistance strain gauge and correct the elastic force data.

4. The spinal orthopedic system according to claim 3, characterized in that, The system also includes: A pressure display module is integrated into the clamp body or connected separately to the clamp body via a wire.

5. A method for monitoring the corrective force in spinal orthopedic surgery, characterized in that, The spinal orthopedic system applied to any one of claims 1 to 4 comprises: Acquire the first elastic force data and first motion data at the first position, and the second elastic force data and second motion data at the second position, collected by the sensor module; The child's current activity status is identified based on the first and second motion data; When the current activity state is a quiet state, the trend of change in elasticity and usage time is obtained by combining the child's growth data and spinal deformity change data; Elastic force calibration data is calculated based on the first elastic force data and the second elastic force data; The elasticity calibration data and the trend of change are compared to analyze whether the spinal correction and elastic structure function are in a normal state.

6. The method according to claim 5, characterized in that, The step of calculating the elasticity calibration data based on the first elasticity data and the second elasticity data includes: The elastic force transmission loss rate of the elastic structure is calculated based on the first elastic force data and the second elastic force data. Based on the elastic transmission loss rate and the usage time of the spinal orthopedic system, analyze whether the corresponding elastic structure is normal. When the elastic structure is in a normal state, elastic force calibration data is calculated based on the first elastic force data and the second elastic force data.

7. The method according to claim 6, characterized in that, The step of analyzing whether the elastic structure is normal based on the elastic transmission loss rate and the usage time of the spinal orthopedic system includes: obtaining a loss rate threshold η0 that matches the usage time, and analyzing whether the elastic structure is normal based on the magnitude between the elastic transmission loss rate and the loss rate threshold. The elastic force transmission loss rate η is calculated according to the formula η=(F1-F2) / F1×100%, and the elastic force calibration data F0 is calculated according to the formula F0=F2×[1+(η0-η) / 100], where F1 is the first elastic force data and F2 is the second elastic force data.

8. The method according to any one of claims 5 to 7, characterized in that, The step of identifying the child's current activity state based on the first and second motion data includes: Calculate the first correlation between the first motion data and the second motion data; Based on the mapping relationship between the first correlation, the first motion data, the second motion data and the activity status, the child's current activity status is determined; The method further includes: When the current activity state is a quiet state, and the duration of the quiet state exceeds a first duration threshold, the elasticity calibration data and the change trend are compared to analyze whether the spinal correction and elastic structure function are in a normal state.

9. A computer-readable storage medium, characterized in that, The computer-readable storage medium stores executable instructions that, when executed by a processor, cause the processor to perform the method as described in any one of claims 5 to 8.

10. An electronic device, characterized in that, include: One or more processors; A memory for storing one or more programs, which, when executed by the one or more processors, cause the one or more processors to perform the method as described in any one of claims 5 to 8.

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