A method of designing a spinal orthosis

Abstract

The present application relates to the field of spinal orthopedic technology, in particular to a kind of spinal orthosis design method.The method is measured by spinal orthopedic measuring device on patient top vertebra area and exerted gradient orthopedic force, determines rated orthopedic force and rated displacement and establishes measured database.Synchronously collect patient BMI, spinal Cobb angle, top vertebra position and other key parameters, and obtain the non-linear quadratic function relationship between multiple groups of parameters by statistical analysis, which can quickly calculate the personalized correction mechanics parameters of patient.The parameters are imported into modeling software to complete three-dimensional model construction, and then the structure is simplified through topology optimization, and finally the orthosis is made by using 3D printing technology.The present application has high modeling accuracy, and the orthosis made has good fit, appropriate and reasonable correction strength, and considers the use safety and correction effect, and the production process is simple and efficient, which can meet the clinical use requirements of precise conservative correction of adolescent idiopathic scoliosis.

Description

Technical Field

[0001] This invention relates to the field of spinal orthopedics, and in particular to a design method for a spinal orthopedic device. Background Technology

[0002] Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that is prevalent during adolescence. Its onset is insidious and its progression is rapid. The deformity is prone to worsen during the peak growth period of adolescence. In severe cases, it can compress cardiopulmonary function, cause back pain, and even require invasive spinal fusion surgery, which has a long-term negative impact on the patient's physical and mental health.

[0003] Currently, the core of conservative treatment for AIS in clinical practice is the wearing of spinal orthoses. However, existing spinal orthoses have many technical shortcomings in design and application, making it difficult to meet the needs of precise correction and dynamic control in the early stages of the disease. In the orthodontic design stage, traditional methods rely heavily on physician experience for manual modeling, lacking scientific quantitative basis. They fail to establish a precise correlation between Cobb angle, patient BMI, and orthodontic force and displacement, resulting in low accuracy of digital modeling. The support curvature and orthodontic force of the orthodontic device do not match the individual spinal deformity characteristics of the patient, easily leading to problems such as poor fit and unsatisfactory orthodontic effect. In fact, excessive or insufficient orthodontic force may even aggravate spinal injury.

[0004] Chinese patent CN115006073A discloses a design and manufacturing method for a scoliosis orthosis, and a scoliosis orthosis. It mainly relies on CT scans and finite element simulation to establish a trunk model, and combines the pressure data collected by the orthosis to establish a regression equation, thereby determining the orthotic force parameters and completing 3D printing manufacturing. However, this approach relies heavily on simulation data, resulting in poor realism. The core orthopedic force is calculated using finite element method (FEM) simulation, which requires extensive simplification of soft tissues such as muscles and ligaments. This leads to a significant discrepancy between the theoretical orthopedic force and the actual force experienced by the patient, making it difficult to directly guide clinical practice. Furthermore, the lack of a dedicated three-dimensional force measurement device results in low data accuracy. Pressure is indirectly collected using ordinary orthotics, lacking specialized force measurement equipment capable of precisely locating the apical region, leading to insufficient data reliability. The force-displacement relationship is not established; only a single relationship between physiological parameters and orthopedic force is established. Force-displacement data in the apical region are not measured, making it impossible to define a rated orthopedic force and displacement that match the patient's tolerance, thus hindering the balance between corrective effect and safety. The modeling relies on shape and simulated force, resulting in poor adaptability. Orthotic modeling depends solely on CT shape data and simulated orthopedic force, neglecting key individual parameters such as BMI and apical position. This leads to a low degree of matching between the orthotics and the patient's spinal deformity characteristics, easily resulting in localized compression or insufficient correction. Summary of the Invention

[0005] To address the technical problem of low accuracy in digital modeling caused by the lack of a precise correlation between Cobb angle, patient BMI, orthopedic force, and orthopedic displacement in existing technologies, this invention provides a spinal orthosis design method.

[0006] Therefore, the present invention provides the following technical solution:

[0007] A spinal orthosis design method is based on a spinal orthosis measuring device. The force measuring device includes a support plate, a support arm is mounted on the support plate, a threaded seat is mounted on the support arm, a threaded screw is mounted on the internal thread of the threaded seat, and a pressure sensor is mounted on the end of the threaded screw facing the support plate. S1. Have the patient stand in the force measurement area of ​​the force measuring device and complete the body posture limit. Rotate the threaded screw of the force measuring device so that the threaded screw feeds into the area to be measured on the patient, and apply an increasing corrective force to the patient. Record the displacement of the apical vertebra and the real-time corrective force. Define the displacement corresponding to when the scoliosis is corrected to the Cobb angle of 0°, or when the patient's pain reaches the limit of tolerance, as the rated displacement and the corresponding corrective force as the rated corrective force. Establish a measured database of corrective force-displacement. S2. Collect patient height and weight data to calculate BMI index, take full-spine anteroposterior X-ray of the patient, and extract the patient's spinal Cobb angle and apical vertebra position body geometric parameters; S3. Based on the patient's measured data, the nonlinear quadratic function relationships of Cobb angle-rated orthopedic force, BMI-rated orthopedic force, and rated orthopedic force-rated displacement were obtained; S4. Substitute the patient's BMI and Cobb angle into the corresponding nonlinear quadratic function to calculate the patient's appropriate rated orthopedic force and rated displacement of the apical region. S5. Input the human body circumference parameters, Cobb angle, apical vertebra position, rated orthopedic force, and rated displacement into the modeling and design software to obtain the three-dimensional model of the orthotine; S6. Import the 3D model of the orthodontic device into the 3D printing equipment to complete the physical fabrication of the orthodontic device.

[0008] Furthermore, the apical vertebral position is the vertebral segment within the scoliosis arc that is furthest from the midline of the human torso and has the greatest degree of vertebral rotation.

[0009] Furthermore, in step S5, the force application area of ​​the three-dimensional model of the orthosis is set according to the position of the apex vertebra, the indentation distance of the force application area into the orthosis is the calculated rated displacement, and the resultant force is the resultant force of the lateral convexity correction pushing force and the vertebral anti-rotation force.

[0010] Further, in step S5, after inputting the human body circumference parameters, Cobb angle, apical vertebra position, rated orthopedic force, and rated displacement into the modeling and design software, the modeling and design software is used to construct a basic framework that matches the patient's torso. After lofting and solid thickening, a preliminary three-dimensional model of the orthosis is obtained. The preliminary three-dimensional model of the orthosis is then topologically optimized to remove redundant materials that do not support the orthopedic area, resulting in the final three-dimensional model of the orthosis.

[0011] Furthermore, the topology optimization adopts the variable density method for iterative calculation, with maximum stiffness as the objective, volume fraction ≤ 65% as the constraint, penalty factor p of 2~5, and number of iterations of 50~200.

[0012] Further, in step S6, the three-dimensional model of the orthodontic device is imported into the 3D printing equipment, and PLA-PCL copolymer is used for integral molding. The layer thickness is 0.05~0.3mm, the nozzle temperature is 190~230℃, the heated bed is 45~60℃, and the printing speed is 40~80mm / s to complete the solid processing and molding.

[0013] Advantages and positive effects of the present invention: This invention uses a spinal orthopedic measuring device to collect force and displacement data of the patient's apical vertebrae. It also combines the Cobb angle and the human body's pain tolerance limit to define the rated orthopedic force and rated displacement. The parameters closely match the patient's actual physical stress state, effectively avoiding the problems of excessive orthopedic force causing physical compression injury or insufficient orthopedic force failing to achieve the corrective effect, thus improving the safety and effectiveness of the treatment.

[0014] Through experimental testing, a stable nonlinear quadratic function relationship was established between the Cobb angle, patient BMI, rated orthopedic force, and rated displacement. This allowed for the mechanical quantification of the orthotic design process, avoiding the problem of insufficient precision caused by traditional orthotic designs relying solely on the physician's subjective experience.

[0015] The BMI index can be calculated based on different patient body types. The Cobb angle of scoliosis and the position of the apex vertebra can be extracted by combining spinal X-ray images. The parameters can be quickly calculated by fitting the fitting function to determine the corrective mechanical parameters specific to the patient. This determines the force application point, indentation distance and resultant force of the orthosis, so that the structure and force distribution of the orthosis are highly consistent with the patient's spinal deformity characteristics, greatly improving the fit and correction accuracy.

[0016] By incorporating both the geometric parameters of spinal deformity and the measured mechanical parameters into the 3D modeling process, and moving away from solely relying on external dimensions for modeling, the overall accuracy of digital modeling is effectively improved. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 This is a graph showing the relationship between the Cobb angle and the rated orthopedic force when the BMI is 16-16.5 according to an embodiment of the present invention.

[0019] Figure 2 This is a graph showing the relationship between rated orthopedic force and rated displacement when the BMI is 16-16.5 according to an embodiment of the present invention.

[0020] Figure 3 This is a graph showing the relationship between BMI and rated orthopedic force when the Cobb angle is between 28 and 30° according to an embodiment of the present invention.

[0021] Figure 4 This is a graph showing the relationship between rated corrective force and rated displacement when the Cobb angle is between 28 and 30°, according to an embodiment of the present invention.

[0022] Figure 5 This is a schematic diagram of the main structure of the support plate of a spinal orthopedic measuring device provided by the present invention.

[0023] Figure 6 This is a front view structural diagram of a spinal orthopedic measurement device provided by the present invention.

[0024] Figure 7 This is a side view structural diagram of a spinal orthopedic measurement device provided by the present invention.

[0025] Figure 8 This is a top view schematic diagram of a spinal orthopedic measurement device provided by the present invention.

[0026] Figure 9 This is a top view of the backrest structure of a spinal orthopedic measurement device provided by the present invention.

[0027] In the diagram: 1. Support plate; 2. Motor lead screw guide rail; 3. Support arm; 4. Base; 5. Anti-slip plate; 6. Side cover; 7. Electric linear module; 8. Backrest panel; 9. Manual lead screw guide rail; 10. Threaded seat; 11. Threaded lead screw; 12. Handwheel; 13. Adjustable armrest; 14. Sliding rod; 15. Clamping nut; 16. Positioning pin; 17. Positioning hole; 18. Support bushing; 19. Adjustment hole; 20. Adjustment pin; 21. Pull rod; 22. Compression spring. Detailed Implementation

[0028] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0029] This invention provides a design method for a spinal orthosis, based on a spinal orthosis measuring device. The force measuring device includes a support plate, a support arm mounted on the support plate, a threaded seat mounted on the support arm, a threaded screw mounted on the internal thread of the threaded seat, and a pressure sensor mounted on one end of the threaded screw facing the support plate.

[0030] S1. Have the patient stand in the force measurement area of ​​the force measuring device and complete the body posture limit. Rotate the threaded screw of the force measuring device to feed the threaded screw towards the patient's test area and apply an increasing corrective force to the patient. Record the displacement of the apical vertebra and the real-time corrective force. Define the displacement corresponding to when the scoliosis is corrected to the Cobb angle of 0° or when the patient's pain reaches the limit of tolerance as the rated displacement and the corresponding corrective force as the rated corrective force. Establish a measured database of corrective force-displacement.

[0031] S2. Collect patient height and weight data to calculate BMI index, take a full-spine anteroposterior X-ray of the patient, and extract the patient's Cobb angle and apical vertebra position as body geometry parameters. The apical vertebra position is the vertebral segment within the scoliosis arc that is furthest from the midline of the human trunk and has the greatest degree of vertebral rotation.

[0032] S3. Based on the patient's measured data, the nonlinear quadratic function relationships of Cobb angle-rated orthopedic force, BMI-rated orthopedic force, and rated orthopedic force-rated displacement were obtained.

[0033] S4. Substitute the patient's BMI and Cobb angle into the corresponding nonlinear quadratic function to calculate the patient's appropriate rated orthopedic force and rated displacement of the apical region.

[0034] S5. Input the human body circumference parameters, Cobb angle, apical vertebra position, rated orthopedic force, and rated displacement into Solidworks modeling software. Use the modeling software to construct a basic framework that matches the patient's torso. After spline curve lofting and solid thickening, a preliminary three-dimensional model of the orthosis is obtained. The preliminary three-dimensional model of the orthosis is then topologically optimized to remove redundant materials that do not support the orthopedic area, resulting in the final three-dimensional model of the orthosis.

[0035] Topology optimization employs a variable density method for iterative calculation, with maximum stiffness as the objective and a volume fraction ≤ 65% as the constraint. The penalty factor p ranges from 2 to 5, and the number of iterations ranges from 50 to 200. Specifically, the penalty factor p = 3, and the number of iterations is 80.

[0036] The force application area of ​​the three-dimensional model of the orthosis is set according to the position of the apex vertebra. The indentation distance of the force application area into the orthosis is the calculated rated displacement. The resultant force is the resultant force of the lateral convexity correction push force and the vertebral anti-rotation force.

[0037] S6. Import the 3D model of the orthodont into the 3D printing equipment, using PLA-PCL copolymer for integral molding. The layer thickness is 0.05~0.3mm, the nozzle temperature is 190~230℃, the heated bed temperature is 45~60℃, and the printing speed is 40~80mm / s to complete the solid molding. Specifically, the layer thickness is 0.2mm, the nozzle temperature is 210℃, the heated bed temperature is 60℃, and the printing speed is 60mm / s.

[0038] Example 1 One eligible male patient, aged 16 years with a BMI of 22.8, was selected. A standing full-spine X-ray examination confirmed AIS (Alzheimer's disease), with a Cobb angle of 31°, the apical vertebra being the second lumbar vertebra, and left lateral lumbar lordosis. The patient cooperated in completing the test. The subject had no history of other spinal diseases and had not received any spinal orthopedic treatment.

[0039] Subjects were positioned in the standing area, maintaining a natural standing posture, and the apical region was marked by the experimenter.

[0040] The pressure sensor is tightly attached to the skin of the corresponding torso area of ​​the apex vertebra, and fixed in place without displacement.

[0041] Rotating the threaded screw drives the pressure sensor to move at a constant speed to the area to be tested at the top of the patient's spine. The pressure sensor monitors the orthopedic force applied to the top of the spine in real time. Tests are conducted on four preset orthopedic force values ​​of 20N, 25N, 30N, and 35N respectively. Each force is measured five times to ensure that the measurement data is accurate and reliable.

[0042] The measurement data were processed using IBM SPSS statistical software 27.0, and a linear regression model between the reference values ​​and the measured values ​​was fitted using the least squares method.

[0043] Based on the provided data (the real-time monitoring system as the baseline and the testing device as the measured value), the linear regression equation is as follows:

[0044] In the formula: x is the real-time monitoring value, The values ​​are predicted by the testing equipment.

[0045] The relevant indicators and standards for regression analysis are shown in the table below: Table 1 Relevant Indicators and Standards

[0046] The relative error analysis is shown in the table below: Table 2 Average relative error at each load point

[0047] The above analysis demonstrates that the spinal orthopedic force testing device possesses excellent measurement performance, with minimal error between the measured results and actual values. Regression analysis shows that the measurement system exhibits excellent linearity (slope = 1.0003, R² = 0.9999), with negligible system bias (intercept = -0.0052N). Within the testing range of 20–35N, the average relative error at each load point is controlled within 0.2%, far exceeding the 5% clinically permissible error limit. The device's accurate measurement capabilities and stable testing performance provide accurate data support for spinal orthopedic treatment.

[0048] Example 2 A total of 330 patients with scoliosis of the single vertebral insufficiency (AIS) were selected, with scoliosis located in the thoracic, thoracolumbar, and lumbar spine. Among them, 110 patients had their apex located in the thoracic spine (55 males, 55 females); 110 patients had their apex located in the thoracolumbar spine (55 males, 55 females); and 110 patients had their apex located in the lumbar spine (55 males, 55 females). All patients had known height, weight, Cobb angle (20°≤Cobb angle≤40°), and apex location. A spinal orthopedic force testing device was used to measure the orthopedic force and the corresponding trunk displacement of the apex under the action of the orthopedic force in all 330 AIS patients. The aim of the experiment was to find the relationship between orthopedic force, the displacement caused by the orthopedic force, Cobb angle, and BMI (Body Mass Index).

[0049] When the BMI is 16-16.5, the relationship between the Cobb angle and the rated orthopedic force is analyzed, such as... Figure 1 As shown, the fitting equation is:

[0050] In the formula, y represents the rated orthopedic force (N), and x represents the Cobb angle (°).

[0051] It is evident that as the Cobb angle increases, the rated orthopedic force generally increases. This indicates that within a certain range, an increase in the Cobb angle necessitates an increase in the rated orthopedic force to achieve the desired orthopedic effect. A least-squares fit to a quadratic polynomial fc reveals a non-linear relationship between the Cobb angle and the rated orthopedic force. The curve shape shows that the increase in rated orthopedic force is not constant, gradually accelerating with increasing Cobb angle. The red curve closely matches the scatter plot distribution, indicating that the fitted model effectively describes the data trend. Some points deviate significantly from the fitted curve, possibly due to measurement errors, individual differences, or other unconsidered factors.

[0052] This study establishes a functional relationship between the Cobb angle and the rated orthopedic force, and investigates the relationship between the rated orthopedic force and the rated displacement. By analyzing and calculating the relationship between the rated orthopedic force and the rated displacement, the rated displacement under the rated orthopedic force is calculated. With a relatively constant BMI and known Cobb angle data, the rated orthopedic force can be calculated quickly and accurately based on the functional relationship between the Cobb angle and the rated orthopedic force. The aim is to find the relationship between the rated orthopedic force and the rated displacement, and to calculate the rated displacement, thus providing orthopedic rated displacement data for the design of spinal orthotics.

[0053] like Figure 2 As shown, the fitting equation is:

[0054] In the formula, y represents the rated displacement (cm) and x represents the rated orthopedic force (N).

[0055] It is evident that as the rated orthopedic force increases, the rated displacement generally shows an increasing trend. This indicates that within a certain range, increasing the rated orthopedic force will increase the rated displacement. The fitted equation is a quadratic polynomial, indicating a non-linear relationship between the rated orthopedic force and the rated displacement. The curve shape shows that the increase in rated displacement is not constant; after the rated orthopedic force reaches its maximum, further increases in rated orthopedic force result in a slower change in rated displacement. This aligns with actual conditions: initially, the rated orthopedic force acts on the apical region; increasing the rated orthopedic force increases the rated displacement. Once the rated orthopedic force has completed spinal correction and the scoliosis has returned to normal, further increases in rated orthopedic force do not significantly change the rated displacement. The red curve and the scatter plot distribution are well-matched, indicating that the fitted model effectively describes the data trend. Some points deviate from the fitted curve, which may be due to measurement errors, individual differences, or other unconsidered factors.

[0056] When the BMI of an AIS patient is relatively constant and the Cobb angle data of an AIS patient is known, the rated orthopedic force can be calculated through the relationship between the rated orthopedic force and the Cobb angle function. Through the relationship between the rated orthopedic force and the rated displacement function, the rated displacement of the trunk region corresponding to the apex vertebra under the action of the rated orthopedic force can be calculated, providing data support for the rated displacement under the action of the rated orthopedic force for spinal orthotics.

[0057] When the Cobb angle is between 28 and 30°, the relationship between BMI and rated orthopedic force is analyzed, such as... Figure 3 As shown, the fitting equation is:

[0058] In the formula, y represents the rated orthopedic force (N), and x represents BMI.

[0059] It is evident that the rated corrective force increases with increasing BMI. This indicates that individuals with higher BMI require greater rated corrective force for spinal correction. The fitted equation is a quadratic polynomial, demonstrating a non-linear relationship between BMI and rated corrective force. The curve shape shows that the increase in rated corrective force is not constant, but gradually accelerates with increasing BMI. The red curve closely matches the distribution of the scatter points, indicating that the fitted model effectively describes the data trend. Some points in the graph deviate from the fitted curve, which may be due to measurement errors, individual differences, or other unconsidered factors. The rated corrective force varies between 20N and 70N. This indicates that the range of rated corrective force variation is large in AIS patients with a BMI between 15 and 25.

[0060] Analyze the relationship between rated orthopedic force and rated displacement, such as Figure 4 As shown, the fitting equation is:

[0061] In the formula, y represents the rated displacement (cm) and x represents the rated orthopedic force (N).

[0062] It is evident that the rated displacement increases with increasing rated orthopedic force. This indicates that increasing the rated orthopedic force within a certain range can produce a larger rated displacement. The fitted equation is a quadratic polynomial, indicating a non-linear relationship between rated orthopedic force and rated displacement. The curve shape shows that the increase in rated displacement is not constant; within a certain range, increasing the rated orthopedic force increases the rated displacement, but after the rated orthopedic force reaches the point of completion, further increases in rated orthopedic force significantly slow down the change in rated displacement. The red curve closely matches the distribution of the scattered points, indicating that the fitted model accurately describes the trend of the data. Some points deviate slightly from the fitted curve, which may be due to measurement errors, individual differences, or other unconsidered factors. The rated displacement varies between 0 cm and 5 cm, indicating that the required rated displacement varies considerably within the range of rated orthopedic force from 0 N to 70 N.

[0063] When the Cobb angle is constant, and given the BMI of an AIS patient, the rated orthopedic force is calculated using the functional relationship between the rated orthopedic force and BMI. Then, using the functional relationship between the rated orthopedic force and rated displacement, the rated displacement of the apical vertebral region under the rated orthopedic force, i.e., the rated displacement of the orthotic force application area, is calculated, providing rated displacement data support for spinal orthotic design. Experiments show a strong correlation between the rated orthopedic force and the rated displacement of the apical vertebral region.

[0064] Experimental results suggest that, for AIS patients with known BMI and Cobb angle data, the rated orthopedic force can be calculated by using the functional relationship between the other parameter and the rated orthopedic force, while keeping one parameter constant. The rated displacement of the trunk region corresponding to the apex vertebra under the rated orthopedic force can then be calculated using the functional relationship between the rated orthopedic force and the rated displacement of the trunk region corresponding to the apex vertebra. This series of derivations and calculations introduces the rated orthopedic force-rated displacement data into the digital design of spinal orthotics, providing methodological and data support for improving the accuracy of spinal orthotics design.

[0065] Example 3 Currently, in clinical practice, the determination of the magnitude, location, and direction of the orthopedic force during the customization of spinal orthopedic braces and the testing of orthopedic force largely relies on the physician's subjective experience, resulting in poor accuracy. Existing measuring devices only offer one-dimensional height adjustment and single-angle measurement functions, failing to achieve multi-dimensional orthopedic force measurement, thus lacking accuracy and effectiveness. Furthermore, the absence of a dedicated patient posture limiting structure makes it easy for non-standard patient postures to cause deviations in the force measurement point.

[0066] Therefore, the spinal orthopedic measuring device used in the design process of the spinal orthopedic device in this application, such as Figure 5-9 As shown, the system includes a support plate 1, on which a motor lead screw guide rail 2 is longitudinally mounted. An upper limit switch and a lower limit switch are also mounted on the support plate 1, corresponding to the upper and lower limit positions of the slider of the motor lead screw guide rail 2, respectively. A support arm 3 is mounted on the slider of the motor lead screw guide rail 2, and a manual lead screw guide rail 9 is horizontally mounted on the support arm 3. A threaded seat 10 is mounted on the slider of the manual lead screw guide rail 9, and a threaded lead screw 11 is threaded onto the internal thread of the threaded seat 10, with the threaded lead screw 11 perpendicularly facing the support plate 1. A force sensor is mounted on the end of the threaded lead screw 11 facing the support plate 1. A handwheel 12 is mounted on the end of the threaded lead screw 11 away from the support plate 1.

[0067] The electric linear modules 7 are longitudinally and parallelly mounted on the support plate 1. The upper sliders of the electric linear modules 7 are all mounted on the same backrest plate 8; the lower sliders of the electric linear modules 7 are also all mounted on the same backrest plate 8. Specifically, as shown... Figure 9 As shown, a positioning pin 16 is fixedly installed on the slider of the electric linear module 7. The positioning pin 16 has a positioning hole 17. A support bushing 18 is slidably fitted onto the outside of the positioning pin 16. The backrest plate 8 is fixedly connected to the end of the support bushing 18. Adjustment holes 19 are sequentially formed along the axial direction on the support bushing 18. Adjustment pins 20 are inserted between the positioning hole 17 and the corresponding adjustment hole 19. A pull rod 21 is installed on the adjustment pin 20. A compression spring 22 is provided inside the support bushing 18, and the compression spring 22 abuts against the end of the adjustment pin 20.

[0068] The backrest panel 8 has a horizontally oriented strip hole, within which two adjustable armrests 13 are slidably installed. Specifically, one end of the adjustable armrest 13 near the supporting upright plate 1 has a sliding rod 14. The diameter of the sliding rod 14 is smaller than the diameter of the adjustable armrest 13. The sliding rod 14 is slidably installed in the strip hole, and a clamping nut 15 is threaded onto the end of the sliding rod 14.

[0069] A side cover 6 is installed on the support plate 1, and the motor lead screw guide rail 2 is located inside the side cover 6; a base 4 is installed at the bottom of the support plate 1, and an anti-slip plate 5 is installed on the upper side of the base 4.

[0070] Working principle: After the patient is in position, the overall height of the backrest 8 is adjusted using the electric linear module 7, and the front-to-back distance of the backrest 8 is adjusted by the cooperation of the positioning pin 16, the support bushing 18, the adjusting pin 20 and the compression spring 22. Then, the adjustable armrest 13 is slidable through the strip hole on the backrest 8, and locked by the sliding rod 14 and the clamping nut 15 to limit and straighten the patient's torso, maintaining a standard upright testing posture.

[0071] The motor lead screw guide rail 2 on the support plate 1 drives the support arm 3 to move vertically. The upper and lower limit switches limit the safe stroke of the slider, achieving coarse adjustment of the force measuring point height. Then, the manual lead screw guide rail 9 on the support arm 3 drives the threaded seat 10 for horizontal fine adjustment, accurately aligning the force sensor at the end of the threaded screw 11 with the part of the patient's spine to be measured. Rotating the handwheel 12 drives the threaded screw 11 to feed axially, allowing the force sensor to smoothly press against the human spine, and collecting the actual orthopedic force parameters in real time. When the patient's spinal Cobb angle reaches 0° or reaches the patient's pain tolerance limit, the measured actual orthopedic force is the rated orthopedic force.

[0072] The entire machine is stable with the base 4 and anti-slip plate 5, and the side cover 6 provides dust protection for the motor lead screw guide rail 2.

[0073] The pressure signal collected by the force sensor is processed by internal A / D conversion and calculation, and the measured orthopedic force, rated orthopedic force, measuring point position, and jacking displacement data are transmitted to the external design system. After receiving the measured data, the external system performs simulation modeling and mechanical matching in combination with the patient's spinal deformity parameters. Based on the real measured data, it completes the digital design of the personalized spinal orthosis structural parameters and finally outputs the model and processing parameters, which are directly used for the customized design and manufacturing of the spinal orthosis.

[0074] The force sensor height is adjusted via a motor-driven lead screw guide, while its horizontal position is finely adjusted via a manual lead screw guide. Once adjusted, the force sensor is aligned with the measurement point on the spine via a handwheel-driven screw feed, enabling three-dimensional position adjustment. The force sensor then collects spinal orthopedic force parameters with high precision. The backrest height is adjusted via an electric linear module to accommodate patients of different heights, while the sliding armrests accommodate patients of different body types, ensuring that patients maintain a standard upright posture. This further improves the authenticity and accuracy of the force measurement data, providing precise measured data for subsequent orthopedic device design.

[0075] Example 4 Most existing conventional orthotics only have passive shaping and correction functions, and cannot monitor the actual orthodontic force under different body postures during daily wear in real time. Medical staff have difficulty accurately grasping the patient's actual wearing status, effective correction time, and the effect of the applied corrective force. They cannot detect abnormalities such as excessive or insufficient orthodontic force or improper wearing in time, and cannot achieve dynamic adjustment of the correction plan. As a result, the orthodontic effect is difficult to guarantee, and it is also easy to cause physical discomfort due to improper force, delaying the best time for correction. Overall, there are significant limitations in clinical use and precise correction effect.

[0076] To address the technical problem that existing orthotics cannot monitor the actual orthopedic force under different body postures during daily wear, thus preventing dynamic adjustment of the correction plan, a spinal orthotics designed using the device in this application is used to monitor the patient's orthopedic status.

[0077] The spinal orthosis designed using the method described in this application includes an orthosis body, a battery, an analog-to-digital converter (ADC), and a controller. The orthosis body has a non-enclosed structure and is equipped with straps for wearing and securing. Pressure sensors are installed in the force application area inside the orthosis body, and the force application area corresponds to the position of the patient's apical vertebra. The signal output terminal of the pressure sensor is connected to the signal input terminal of the ADC, and the signal output terminal of the ADC is connected to the signal input terminal of the controller. The ADC and controller are both located on the outside of the orthosis body, and the power terminals of the pressure sensor, ADC, and controller are all electrically connected to the battery. The signal output terminal of the controller is connected to the cloud platform of an external smart terminal.

[0078] The pressure sensor is a thin-film pressure sensor, characterized by its thinness, softness, and conformability to the human body surface. It can fit closely to the inside of the orthosis and make close contact with the patient's body without affecting daily limb activities. It can accurately sense the compressive force on the apical region. The battery is a flexible lithium film battery, which is soft and can be installed on the outer wall of the orthosis. It occupies little space, adapts to the wearing shape of the orthosis, and can provide stable power for a long time to meet the needs of all-weather wearable monitoring. The controller is an ESP32 controller, which integrates wireless communication functions and can stably complete data processing and wireless signal transmission and reception. The analog-to-digital converter is a 16-bit ADC, which can accurately acquire the weak analog electrical signals output by the pressure sensor, improve the accuracy of pressure value acquisition, and reduce data acquisition errors.

[0079] The orthosis is fitted with a protective shell on the outside, and the analog-to-digital converter and controller are located inside the protective shell to avoid bumps and knocks during daily wear.

[0080] Monitoring using this spinal orthosis includes the following steps: S1. Measure the rated orthopedic force required for spinal correction using an orthopedic force measuring device, and record the rated orthopedic force value in the cloud platform of an external smart terminal; before formal monitoring, medical staff first use a dedicated force measuring device to determine the rated orthopedic force suitable for the patient based on the degree of scoliosis and body characteristics, and complete the filing and storage of basic correction parameters.

[0081] S2. Manufacture a spinal orthosis based on the patient's body parameters and rated orthopedic force; combine the patient's height, body circumference, spinal deformity location and the calculated rated orthopedic force to customize and process a spinal orthosis of the corresponding specifications, ensuring that the overall shape of the orthosis fits the patient's back curve and the force application point is accurately aligned with the correction position of the top vertebra of the spine.

[0082] S3. The patient wears a spinal orthosis, and the actual orthopedic force applied to the patient by the spinal orthosis is monitored in real time by pressure sensors. The patient wears the orthosis neatly against the back and completes the wearing and fixation by the outer strap of the main body. After the orthosis is worn, the pressure sensors installed on the inner side can collect the actual compression force on the correction area around the clock, realizing dynamic data collection at all times.

[0083] S4. The actual orthopedic force is converted into a digital signal by an analog-to-digital converter and transmitted to the controller. The controller then transmits the digital signal to the cloud platform of the external smart terminal. The continuous analog pressure signal collected by the pressure sensor is converted into a digital signal that can be recognized and read by the controller through an analog-to-digital converter. The controller then transmits the real-time orthopedic force data wirelessly to the smart terminal held by the patient. Finally, the data is aggregated and uploaded to the backend cloud platform for unified data storage.

[0084] The S5 cloud platform compares the actual orthopedic force with the rated orthopedic force, and evaluates the spinal correction effect under the patient's standing posture and in the state of wearing the device at all times.

[0085] When the patient is standing, the orthopedic effect is rated as excellent when the actual orthopedic force is 90% to 105% of the rated orthopedic force; good when the actual orthopedic force is 75% to 90% of the rated orthopedic force; effective when the actual orthopedic force is 50% to 75% of the rated orthopedic force; and ineffective when the actual orthopedic force is less than 50% of the rated orthopedic force.

[0086] When the actual orthopedic force exceeds 105% of the rated orthopedic force, the smart terminal issues an alert, reminding the patient to loosen the bandage; when the actual orthopedic force is less than 50% of the rated orthopedic force, the smart terminal issues an alert, reminding the patient to tighten the bandage.

[0087] When the patient is in any posture other than standing, the orthopedic effect is considered effective when the actual orthopedic force is 0-30% of the rated orthopedic force.

[0088] The orthotic force measured by the pressure sensor is the highest when the patient is standing and the lowest when the patient is lying down. When the orthotic force measured by the pressure sensor fluctuates between the maximum and minimum values, it indicates that the patient's position has changed and the orthosis is working normally. When the orthosis is in a continuously ineffective state for more than 12 hours, the smart terminal issues an early warning to remind the patient to tighten the straps.

[0089] S6. When the assessment result is invalid, the smart terminal issues an alert, reminding the patient to adjust the orthotic straps until the orthotic effect is assessed as effective. After receiving the abnormal force warning, the patient can independently fine-tune the tightness of the straps, changing the corrective force applied by the orthotic in real time until the monitoring data returns to the effective range.

[0090] Thin-film pressure sensors are installed in the force application area inside the orthosis to collect actual orthopedic force data continuously around the clock. After being accurately converted by an analog-to-digital converter, the data is uploaded to the cloud platform and smart terminal in real time through the controller, realizing dynamic monitoring of orthopedic force. Medical staff and patients can keep track of the wearing status and correction effect at any time, and realize dynamic adjustment of the correction plan.

[0091] The cloud platform automatically compares the actual orthopedic force with the rated orthopedic force. When the patient is standing, if the actual orthopedic force is too large, exceeding 105% of the rated orthopedic force, or insufficient, below 50% of the rated orthopedic force, or when the patient is in a posture other than standing, and the actual orthopedic force exceeds 0-30% of the rated orthopedic force, the smart terminal will issue an early warning to remind the patient to adjust the straps in time to ensure that the corrective force is always within the effective range and to avoid delaying the treatment opportunity.

[0092] Different body postures are graded and assessed to avoid misjudgment of the orthodontic effect and improve practicality.

[0093] Example: Setting the baseline: Patient A, aged 14, was wearing and fitting a pressure sensor orthosis for the first time. The doctor had the patient stand still and measured the maximum orthotic force (rated orthotic force).

[0094] Account binding: The doctor generates a unique invitation code on the web interface. Patient A's guardian enters the code into a mini-program on an external smart terminal to complete the registration, and the two systems are successfully bound together.

[0095] It needs to be worn for approximately 22 hours each day. In the evening, the guardian turns on the Bluetooth of their smart device, accesses the mini-program, connects to the orthotics controller via Bluetooth, and uploads the day's orthotics force data to the cloud.

[0096] Static (standing) real-time monitoring: On Saturday morning, when patient A was standing, the caregiver viewed the real-time orthopedic force via a mini-program. Excellent: 95% of rated force (between 90% and 105%). System evaluation is excellent; continue to maintain this level.

[0097] Excessive force: exceeding 105%. The doctor suggested via a mini-program: Please loosen the restraints appropriately to prevent pressure sores.

[0098] The force is too low: between 50% and 75%. Doctor's advice: Please tighten the bandage to improve the effect.

[0099] Failure: Excluding cases where the garment was not worn, this indicates a design failure, and the system prompts the user to seek immediate medical attention for replacement.

[0100] The comprehensive 24-hour dynamic assessment takes into account that patient A's force may decrease during dynamic activities such as walking and sleeping. The system uses >30% of rated force as the effective working state and calculates the percentage of effective time per day:

[0101] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention 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; and these 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 the present invention.

Claims

1. A method for designing a spinal orthosis, characterized in that, Based on a spinal orthopedic measuring device, the force measuring device includes a support plate, a support arm mounted on the support plate, a threaded seat mounted on the support arm, a threaded screw mounted on the internal thread of the threaded seat, and a pressure sensor mounted on the end of the threaded screw facing the support plate. S1. Have the patient stand in the force measurement area of ​​the force measuring device and complete the body posture limit. Rotate the threaded screw of the force measuring device so that the threaded screw feeds into the area to be measured on the patient, and apply an increasing corrective force to the patient. Record the displacement of the apical vertebra and the real-time corrective force. Define the displacement corresponding to when the scoliosis is corrected to the Cobb angle of 0°, or when the patient's pain reaches the limit of tolerance, as the rated displacement and the corresponding corrective force as the rated corrective force. Establish a measured database of corrective force-displacement. S2. Collect patient height and weight data to calculate BMI index, take full-spine anteroposterior X-ray of the patient, and extract the patient's spinal Cobb angle and apical vertebra position body geometric parameters; S3. Based on the patient's measured data, the nonlinear quadratic function relationships of Cobb angle-rated orthopedic force, BMI-rated orthopedic force, and rated orthopedic force-rated displacement were obtained; S4. Substitute the patient's BMI and Cobb angle into the corresponding nonlinear quadratic function to calculate the patient's appropriate rated orthopedic force and rated displacement of the apical region. S5. Input the human body circumference parameters, Cobb angle, apical vertebra position, rated orthopedic force, and rated displacement into the modeling and design software to obtain the three-dimensional model of the orthotine; S6. Import the 3D model of the orthodontic device into the 3D printing equipment to complete the physical fabrication of the orthodontic device.

2. The spinal orthosis design method according to claim 1, characterized in that, The apical vertebra is the vertebral segment within the scoliosis arc that is furthest from the midline of the human torso and has the greatest degree of rotation.

3. The spinal orthosis design method according to claim 1, characterized in that, In step S5, the force application area of ​​the three-dimensional model of the orthosis is set according to the position of the apex vertebra, the indentation distance of the force application area into the orthosis is the calculated rated displacement, and the resultant force is the resultant force of the lateral convexity correction pushing force and the vertebral anti-rotation force.

4. The spinal orthosis design method according to claim 1, characterized in that, In step S5, after inputting the human body circumference parameters, Cobb angle, apical vertebra position, rated orthopedic force, and rated displacement into the modeling and design software, the software is used to construct a basic framework that matches the patient's torso. After lofting and solid thickening, a preliminary three-dimensional model of the orthosis is obtained. The preliminary three-dimensional model of the orthosis is then topologically optimized to remove redundant materials that do not support the orthopedic area, resulting in the final three-dimensional model of the orthosis.

5. The spinal orthosis design method according to claim 4, characterized in that, The topology optimization adopts the variable density method for iterative calculation, with maximum stiffness as the objective, volume fraction ≤65% as the constraint, penalty factor p of 2~5, and number of iterations of 50~200.

6. The spinal orthosis design method according to claim 1, characterized in that, In step S6, the three-dimensional model of the orthodontic device is imported into the 3D printing equipment, and PLA-PCL copolymer is used for integral molding. The layer thickness is 0.05~0.3mm, the nozzle temperature is 190~230℃, the heated bed is 45~60℃, and the printing speed is 40~80mm / s to complete the solid processing and molding.

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