A Design Method for a Scoliosis Orthosis

Abstract

The present invention provides a design method for a scoliosis orthosis, belonging to the technical field of scoliosis orthoses, including: establishing a personalized human body surface model and a bone model of a patient based on the 3D scan and X-ray / CT data of the patient; fusing the two models into a human body correction model and determining its safety range, such as the maximum correction angle, pressure bearing limit, etc.; obtaining a preset orthosis 3D model and calculating correction parameters through finite element analysis, including pressure distribution, correction moment, etc.; optimizing the shape, thickness and material properties of the orthosis by using a genetic algorithm to obtain multiple groups of optimized parameters; performing finite element analysis again to verify the optimization effect and obtaining the optimal correction parameters; calculating the specific design parameters of the scoliosis orthosis according to the optimal parameters, manufacturing a sample and testing; fine-tuning the parameters according to the patient's feedback and clinical evaluation to determine the final target parameters of the scoliosis orthosis. It solves the technical problem that the existing method relies on the personal experience of orthotists and is not accurate enough.

Description

Technical Field

[0001] The present invention belongs to the technical field of scoliosis orthosis, and specifically relates to a design method for a scoliosis orthosis. Background Art

[0002] Scoliosis is a common spinal deformity disease, mainly occurring during adolescence, which seriously affects the physical and mental health and daily life of patients. The causes of scoliosis are complex, including genetic factors, abnormal growth and development, muscle tension imbalance, osteoporosis and other aspects. According to the severity of the scoliosis, it can be divided into three stages: mild, moderate and severe. Mild scoliosis can be corrected by physical therapy and orthosis, while moderate and severe scoliosis requires surgical treatment.

[0003] Orthopedic treatment is the most common non-surgical treatment method for scoliosis. The role of the orthosis is to apply external force on the spine and trunk to improve the position and shape of the spine and trunk, so as to achieve the purpose of correcting scoliosis. The existing scoliosis orthoses mainly have two types: rigid bracket type and soft wrapping type. The rigid bracket type orthosis is made of rigid materials such as plastic or metal and can provide strong support; the soft wrapping type orthosis is made of cloth or soft plastic and is relatively more comfortable and beautiful.

[0004] The traditional design of scoliosis orthosis mainly relies on the experience of orthotists and manual shaping. Orthotists usually first determine the severity and deformation state of scoliosis based on the patient's X-ray or CT scan data, and then perform manual shaping on a plaster mannequin to produce a preliminary orthosis sample. Subsequently, the patient wears the orthosis, and the correction effect is checked by X-ray reexamination. If the effect is not ideal, the shape and pressure point position of the orthosis need to be adjusted continuously until the ideal correction effect is achieved. This experience-dependent manual design method has many limitations:

[0005] 1. The design time is long, and it needs to be adjusted many times to achieve a satisfactory correction effect, which brings a large time and energy cost to patients and orthotists.

[0006] 2. It is difficult to accurately predict the force of the orthosis on the spine and trunk, and it is easy to have the situation of local overcompression or failure to achieve the expected correction effect.

[0007] 3. It is difficult to evaluate the comfort and wear resistance of the orthosis, and it is difficult to optimize these indicators at the design stage. Summary of the Invention

[0008] In view of this, the present invention provides a design method for a scoliosis orthosis, which can solve the technical problems that the existing methods often rely on the personal experience of orthotists and manual shaping, resulting in a long design time and insufficient accuracy.

[0009] The present invention is implemented as follows:

[0010] The first aspect of the present invention provides a design method for a scoliosis orthosis, which includes the following steps:

[0011] S10. Based on the 3D human scan image of the patient and the standard human surface model matching the patient's basic information, establish a 3D model of the patient's human surface;

[0012] S20. Based on the X-ray or CT scan data of the patient and the standard human bone 3D model matching the patient's basic information, establish a 3D model of the patient's bones;

[0013] S30. Integrate the 3D human surface model and the 3D bone model into a human correction model, and determine the safety range of the human correction model, including the maximum correction angle of each spinal segment, the bearing limit of the ribs and hip bones, and the pressure threshold of soft tissues;

[0014] S40. Obtain a preset orthosis 3D model, wear it outside the human correction model in a wearable manner, and use finite element analysis to calculate multiple sets of correction data, including the pressure distribution of the orthosis on the human body, correction moment, friction force, the force condition of each spinal segment, intervertebral disc pressure, muscle stretching degree, and soft tissue deformation degree;

[0015] S50. Using the multiple sets of correction data as input variables and the correction effect, comfort, orthosis weight, and durability as multi-objective fitness functions, adopt a genetic algorithm to optimize the shape, thickness distribution, and material properties of the orthosis to obtain multiple sets of optimized correction parameters;

[0016] S60. Modify the orthosis 3D model according to the optimized correction parameters, and perform a second round of finite element analysis to verify the optimization effect and obtain the optimal correction parameters;

[0017] S70. Calculate the parameters of the scoliosis orthosis according to the optimal correction parameters, including the overall shape of the orthosis, thickness distribution, material selection, pressure point position, correction force application point, support structure design, ventilation hole layout, and fixation belt position;

[0018] S80. Make an orthosis sample according to the parameters of the scoliosis orthosis, test the wearing effect of the patient, and fine-tune the parameters of the scoliosis orthosis according to the patient's feedback and clinical evaluation to obtain the target parameters of the scoliosis orthosis for making the scoliosis orthosis.

[0019] Among them, the step S10 specifically includes the following steps: Obtain point cloud or mesh data describing the patient's body surface shape according to the patient's three-dimensional body scan image; Use data preprocessing techniques to denoise, smooth, and repair missing areas of the original scan data to improve data quality; Prepare a standard three-dimensional model of the human body surface that matches the patient's basic information, and this model is established by statistically analyzing anthropometric data; Use a non-rigid registration algorithm, such as the Iterative Closest Point (ICP) algorithm, to perform deformation registration on the processed patient scan data and the standard model to make it fit the patient's actual body surface shape to the greatest extent; Finally, combine human anatomy knowledge to further optimize the detailed shape of the three-dimensional model to obtain a three-dimensional model that accurately describes the patient's body surface.

[0020] Among them, the step S20 specifically includes the following steps: Obtain medical imaging data describing the patient's bone structure, such as X-ray films or CT tomograms; Use image segmentation techniques, such as algorithms based on thresholds or region growing, to extract individual bone regions from the medical imaging data; Prepare a standard three-dimensional model of the human body bones that matches the patient's basic information, and this model is also established by statistically analyzing measurement data; Use rigid / non-rigid registration algorithms based on feature points or surfaces to register and deform the segmented patient bone data and the standard bone model to make it coincide with the patient's actual bone structure; Finally, combine bone anatomy knowledge to further optimize the detailed shape of the three-dimensional model to obtain a three-dimensional model that accurately describes the patient's bone structure.

[0021] Among them, the step S30 specifically includes the following steps: Register and fuse the three-dimensional model of the human body surface and the three-dimensional model of the bones constructed in steps S10 and S20 to generate a comprehensive three-dimensional model of human body correction; For this three-dimensional model of human body correction, combine information such as the patient's scoliosis degree, bone age development status, and muscle flexibility to determine safety range parameters such as the maximum allowable correction angle of each spinal segment, the bearing limit of the ribs and hip bones, and the pressure threshold of soft tissues during the correction process.

[0022] Among them, the step S40 specifically includes the following steps: Prepare an initial three-dimensional model of the orthosis, which includes parameters such as the overall shape, thickness distribution, and material properties of the orthosis; Register and combine the three-dimensional model of human body correction constructed in step S30 with the preset three-dimensional model of the orthosis to simulate the actual situation of the orthosis worn on the patient; Use finite element analysis technology to calculate various indicators such as the pressure distribution, correction moment, friction force exerted by the orthosis on the human body in the worn state, the force conditions of each spinal segment, the intervertebral disc pressure, the degree of muscle stretching, and the degree of soft tissue deformation.

[0023] Among them, the specific steps of step S50 include the following: Establish a multi-objective fitness function with the correction effect, comfort, orthosis weight, and durability as the objectives; Use the genetic algorithm to optimize parameters such as the geometric shape, thickness distribution, and material properties of the orthosis to obtain the optimal design scheme that meets various performance requirements. The genetic algorithm performs iterative optimization through steps such as coding, initialization, fitness evaluation, selection, and genetic operations, and finally outputs the individual with the highest fitness, which is the optimized orthosis design parameter.

[0024] Among them, the specific steps of step S60 include the following: Apply the optimized orthosis design parameters obtained in step S50 to the preset three-dimensional model to generate the modified orthosis three-dimensional model; Register and combine the modified orthosis model with the human body correction model in step S30 again; Use the finite element analysis technology to recalculate various performance indicators of the modified orthosis on the human body in the wearing state, such as pressure distribution, correction moment, spinal force, etc.; Compare the analysis results before and after optimization to verify whether the optimization effect meets the requirements. If further optimization is still required, return to step S50 for repeated iteration.

[0025] Among them, the specific steps of step S70 include the following: According to the optimal orthosis design parameters obtained in step S60, such as shape, thickness distribution, material properties, pressure point position, correction force application point, etc., use technical means such as B-spline surface fitting, gradient thickness design, and material selection to calculate the overall structure, local structure, and key performance indicators of the scoliosis orthosis; These parameters provide a technical basis for the subsequent manufacture of orthosis samples.

[0026] Among them, the specific steps of step S80 include the following: Make a physical sample according to the orthosis parameters calculated in step S70; Invite the target patient to try on the sample, observe and record the patient's wearing feedback, including aspects such as adaptability, stability, degree of activity limitation, correction effect, comfort, and weight perception; At the same time, invite a clinician to conduct a professional evaluation of the sample and put forward optimization suggestions; Integrate the patient feedback and clinical evaluation results, and make fine-tuning of the original parameters to ensure that the final design scheme can meet the personalized needs of the patient; Finally, determine the target parameters of the scoliosis orthosis.

[0027] Among them, the basic patient information includes bone age, muscle fat value, body softness, tolerable orthopedic strength, scoliosis degree, spinal rotation degree, growth rate, age, gender, and weight.

[0028] Among them, the correction effect is used to evaluate the improvement degree of the Cobb angle, evaluate the correction degree of spinal rotation, and evaluate the improvement of body type symmetry.

[0029] Among them, the comfort level is used to evaluate the uniformity of pressure distribution, evaluate the ratio of the contact area to the total surface area, evaluate the degree of soft tissue deformation, evaluate the ventilation and thermal comfort, and evaluate the degree of restriction of the range of motion.

[0030] Among them, the orthosis weight is used to calculate the volume of the orthosis according to the 3D model, calculate the total weight by combining the density of the selected material, evaluate the uniformity of weight distribution, and evaluate the impact of the weight on the patient's daily activities.

[0031] Among them, the durability is used to conduct material fatigue analysis, evaluate the structural strength of high-stress areas, simulate the deformation after long-term use, consider the wear resistance and corrosion resistance of the material, and evaluate the reliability of seams and connection parts.

[0032] That is to say, in the multi-objective fitness function, the correction effect considers the Cobb angle improvement, spinal rotation correction, body shape symmetry improvement, and long-term correction stability; the comfort level considers the pressure distribution uniformity, contact area ratio, soft tissue deformation degree, ventilation, and range of motion restriction; the weight score considers the total weight, weight distribution uniformity, and impact on daily activities; the durability considers material fatigue, structural strength, long-term deformation, wear resistance, corrosion resistance, and seam reliability. The following is how to calculate each parameter of the scoliosis orthosis according to the optimal correction parameters:

[0033] 1. Overall shape of the orthosis:

[0034] Based on the patient's 3D body scan model, combined with the spinal correction angle in the optimal correction parameters, generate the basic contour of the orthosis.

[0035] Use the surface fitting algorithm to ensure that the orthosis shape matches the patient's body shape while achieving the ideal correction effect.

[0036] Considering the patient's activity needs, while ensuring the correction effect, optimize the shape of the orthosis in key areas such as the armpit and buttocks to improve comfort.

[0037] 2. Thickness distribution:

[0038] According to the finite element analysis results, determine the stress that each part of the orthosis needs to bear.

[0039] Increase the thickness in high-stress areas and appropriately thin in low-stress areas to optimize the weight distribution.

[0040] Use the gradient thickness design to ensure a smooth transition between each part of the orthosis and avoid stress concentration.

[0041] Considering the patient's weight and activity level, adjust the overall thickness range.

[0042] 3. Material selection:

[0043] Based on the stiffness requirements in the optimal correction parameters, select the appropriate main material (such as polyethylene, carbon fiber composite materials, etc.).

[0044] Soft, breathable padding material is used at pressure points and friction areas.

[0045] Consider the patient's skin sensitivity and choose hypoallergenic materials.

[0046] Select appropriate surface treatment or coating material according to durability requirements.

[0047] 4. Pressure point location:

[0048] According to the pressure distribution data in the optimal correction parameters, the location of the main pressure point is determined.

[0049] Consider the patient's bony prominences and sensitive areas and adjust the location of pressure points to avoid discomfort.

[0050] Design pressure-dissipating structures, such as bumps or pads, to optimize pressure distribution.

[0051] 5. Correction force application point:

[0052] Based on the type and severity of scoliosis, determine where the primary corrective force is applied.

[0053] Considering the three-point pressure principle, the direction and magnitude of the corrective force are designed.

[0054] Adjust the specific location of the correction force application point according to the patient's muscle strength and flexibility.

[0055] 6.Support structure design:

[0056] According to the stiffness requirements in the optimal correction parameters, the main supporting structure of the orthosis is designed.

[0057] Add reinforcing ribs or bracing strips in high stress areas.

[0058] Designed with adjustable support structure to accommodate patient growth and correction progression.

[0059] 7. Ventilation hole layout:

[0060] Based on the results of the thermal comfort analysis, determine the areas that need increased ventilation.

[0061] The size, shape and distribution of the vents are designed to maximize ventilation effect while ensuring structural strength.

[0062] Consider the patient's activity patterns and increase ventilation in areas with high activity.

[0063] 8. Fixed belt position:

[0064] Determine the position of the main fixation band according to the correction force application point and pressure distribution.

[0065] Design the width and angle of the fixation band to ensure stability and comfort.

[0066] Consider the patient's daily wearing and removing needs, and optimize the layout of the fixation band for convenient operation.

[0067] When calculating these parameters, it is necessary to comprehensively consider various data in the optimal correction parameters, such as correction angle, pressure distribution, stress analysis, etc. At the same time, it is also necessary to make personalized adjustments in combination with the patient's individual characteristics (such as age, body type, activity level, etc.). In addition, computer-aided design (CAD) software and parametric modeling technology can be used to quickly generate and adjust the 3D model of the orthosis to achieve accurate parameter calculation and optimization.

[0068] Among them, the standard human surface model and bone model are constructed by collecting a large amount of human measurement data and using technical means such as mesh generation and surface reconstruction.

[0069] Among them, the design of the overall shape adopts the B-spline surface fitting algorithm, and by adjusting the positions and weights of the control points, it is used to achieve the best match between the orthosis contour and the patient's body type.

[0070] Among them, the design of the thickness distribution adopts the gradient thickness design method, increasing the thickness in the high-stress area and thinning in the low-stress area, while ensuring a smooth transition between different parts.

[0071] Among them, the design of the ventilation hole layout adopts the Poisson disk sampling algorithm, and according to the local stress distribution and temperature field, optimizes the size, shape and distribution of the ventilation holes.

[0072] Compared with the prior art, the beneficial effects of a design method for a scoliosis orthosis provided by the present invention are:

[0073] 1. Accurately describe the patient's anatomical structure: The method of the present invention can establish a fine three-dimensional model including the human surface shape and bone structure according to the patient's body scan data and medical imaging materials. This can not only accurately capture the individual characteristics of the patient, but also provide a reliable geometric basis for subsequent orthosis design. In contrast, existing orthoses mostly rely on empirical human measurement data and cannot fully reflect the personalized needs of patients.

[0074] 2. Achieve multi-objective orthosis optimization: The method of the present invention uses a genetic algorithm to optimize the design of parameters such as the geometric shape, thickness distribution, and material properties of the orthosis, while considering multiple performance objectives such as correction effect, comfort, weight, and durability. By weighing these objective indicators, an optimized orthosis that takes into account both the correction effect and the user experience can be designed. Compared with the previous design method that solely pursued the correction effect, the solution of the present invention pays more attention to the overall needs of patients.

[0075] 3. Improve the level of personalization in corrective treatment: The method of the present invention combines computer-aided design technology to customize and design the best orthosis for each patient's individual characteristics. It can not only accurately match the patient's anatomical structure but also optimize parameters according to factors such as their correction needs, activity level, and skin sensitivity. This personalized design solution helps to improve the pertinence and satisfaction of corrective treatment.

[0076] 4. Enhance the quality of life after correction: Based on the correction effect, the method of the present invention also focuses on the comfort and durability of the orthosis. By optimizing indicators such as pressure distribution, freedom of movement, and weight perception, it can significantly improve the patient's experience in daily life and activities, thereby enhancing their quality of life. Compared with existing orthoses, the design of the present invention pays more attention to the overall user experience of patients.

[0077] In summary, the scoliosis orthosis design method based on computer-aided design proposed by the present invention can make full use of the individual characteristics of patients to design a customized orthosis that can not only effectively correct spinal deformities but also improve the patient's use experience. The core of this method lies in the adoption of advanced computer technologies such as three-dimensional modeling, finite element analysis, and genetic algorithm optimization, which systematically solve the multi-objective optimization problem in orthosis design and address the technical problems mentioned in the background art, where existing methods often rely on the personal experience of orthotists and manual modification, resulting in long design time and insufficient accuracy. Brief Description of the Drawings

[0078] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following will briefly introduce the drawings required for the description of the embodiments of the present invention. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0079] Figure 1 It is a flowchart of the method provided by the present invention; Detailed Embodiments

[0080] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention.

[0081] As Figure 1 shown, it is a flowchart of a design method for a scoliosis orthosis provided by the present invention. This method includes the following steps:

[0082] S10. Based on the 3D human scan image of the patient, establish a 3D human surface model of the patient based on the human standard surface model matching the patient's basic information;

[0083] S20. Based on the X-ray or CT scan data of the patient, establish a 3D bone model of the patient based on the human standard bone 3D model matching the patient's basic information;

[0084] S30. Integrate the 3D human surface model and the 3D bone model into a human correction model, and determine the safety range of the human correction model, including the maximum correction angle of each spinal segment, the bearing limit of the ribs and hip bones, and the pressure threshold of soft tissues;

[0085] S40. Obtain a preset 3D orthosis model, wear it on the outside of the human correction model by wearing, and use finite element analysis to calculate multiple sets of correction data, including the pressure distribution of the orthosis on the human body, correction moment, friction force, and the force conditions of each spinal segment, intervertebral disc pressure, muscle stretching degree, and soft tissue deformation degree;

[0086] S50. Using multiple sets of correction data as input variables and correction effect, comfort, orthosis weight, and durability as multi-objective fitness functions, adopt a genetic algorithm to optimize the shape, thickness distribution, and material properties of the orthosis to obtain multiple sets of optimized correction parameters;

[0087] S60. Modify the 3D orthosis model according to the optimized correction parameters, and perform a second round of finite element analysis to verify the optimization effect and obtain the optimal correction parameters;

[0088] S70. Calculate the parameters of the scoliosis orthosis according to the optimal correction parameters, including the overall shape, thickness distribution, material selection, pressure point position, correction force application point, support structure design, ventilation hole layout, and fixation band position of the orthosis;

[0089] S80. Make an orthosis sample according to the parameters of the scoliosis orthosis, test the wearing effect of the patient, and fine-tune the parameters of the scoliosis orthosis according to the patient's feedback and clinical evaluation to obtain the target parameters of the scoliosis orthosis for making the scoliosis orthosis.

[0090] The following will describe in detail the specific implementation manners of the above steps:

[0091] Step S10: Establish a 3D model of the patient's body surface based on the 3D human body scan image of the patient.

[0092] The purpose of this step is to establish a 3D model that accurately describes the shape of the patient's body surface based on the actual human body scan data of the patient. The specific implementation is as follows:

[0093] 1. Obtain the human body scan data of the patient: Usually, technologies such as optical scanners or CT / MRI scans can be used to obtain the three-dimensional human body surface data of the patient. These scan data record the three-dimensional coordinate information of the entire body surface of the patient in the form of point clouds or meshes.

[0094] 2. Perform data preprocessing: Since there may be some noise or missing data during the scanning process, it is necessary to preprocess the original scan data first. Common preprocessing techniques include denoising, smoothing, and repairing missing areas, etc. This step can use open-source point cloud processing libraries.

[0095] 3. Build a standard human body surface model: Prepare a general 3D model of the human body surface in advance, and this model needs to match the basic information of the patient (such as gender, age, height, etc.). This standard model can be established by statistically analyzing human body measurement data and using 3D modeling software such as Maya or Blender, etc.

[0096] 4. Registration and deformation: Register and deform the preprocessed patient scan data with the standard human body surface model so that the standard model can best match the actual human body surface of the patient. This process can adopt non-rigid registration algorithms, such as the deformation method based on the Iterative Closest Point (ICP).

[0097] 5. Model optimization: After completing the preliminary model deformation, it is necessary to further optimize the model details to ensure the authenticity and accuracy of the 3D model of the patient's body surface. This can combine human anatomy knowledge and adopt technical means such as surface fitting and mesh refinement to improve the geometric shape of the model.

[0098] Through the above steps, a 3D model that accurately describes the shape of the patient's body surface can be established based on the actual scan data of the patient. This model will lay the foundation for the subsequent construction of the bone model and the establishment of the human body correction model.

[0099] Step S20: Establish a 3D model of the patient's bones based on the X-ray or CT scan data of the patient.

[0100] The purpose of this step is to construct a three-dimensional model that accurately describes the bone structure of the patient based on the medical imaging data of the patient. The specific implementation is as follows:

[0101] 1. Obtain the X-ray or CT scan data of the patient: Through the imaging examinations in the hospital, obtain the medical imaging data that describes the patient's bone structure, such as X-ray films or CT tomographic scans. These data record the three-dimensional distribution information of the patient's bones in the form of grids or voxels.

[0102] 2. Perform image segmentation: Since medical imaging data usually contains various tissue structures such as soft tissues and bones, it is necessary to first segment the imaging data to extract the separate bone regions. This step can utilize image segmentation algorithms based on thresholds or region growing.

[0103] 3. Construct a standard bone model: Similar to the human body surface model, prepare a general 3D human bone model in advance, and this model needs to match the patient's basic information (such as gender, age, height, etc.). This standard model can be constructed by statistically analyzing bone measurement data and using professional 3D modeling software.

[0104] 4. Registration and deformation: Register and deform the segmented patient bone data with the standard bone model so that the standard model can best match the patient's actual bone structure. This process can adopt rigid / non-rigid registration algorithms based on feature points or surfaces.

[0105] 5. Model optimization: After completing the preliminary model deformation, it is necessary to further optimize the model details to ensure the authenticity and accuracy of the patient's 3D bone model. This can combine bone anatomy knowledge and adopt technical means such as surface reconstruction and mesh refinement to improve the geometric shape of the model.

[0106] Through the above steps, it is possible to establish a 3D model that accurately describes the patient's bone structure based on the patient's actual medical imaging data. This model will provide the basis for the geometric information of the bone for the subsequent establishment of the human body correction model.

[0107] Step S30: Integrate the 3D human body surface model and the 3D bone model into a human body correction model and determine the safety range

[0108] The purpose of this step is to integrate the human body surface model and the bone model constructed in steps S10 and S20 into a comprehensive human body correction model and determine the safety range of this model during the correction process. The specific implementation method is as follows:

[0109] 1. Model integration: Register and integrate the 3D human body surface model and the 3D bone model obtained in steps S10 and S20 to generate a complete human body correction model. This process can adopt methods based on rigid body transformation or non-rigid registration to ensure that the surface model and the bone model are in agreement in terms of geometric position and posture.

[0110] 2. Model refinement: After completing the preliminary model fusion, it is necessary to further optimize and refine the human body correction model to ensure the authenticity and integrity of its anatomical structure. This includes adjusting the relative position relationship between bones and soft tissues, improving the geometric details of joint parts, and adding soft tissue structures such as muscles and ligaments.

[0111] 3. Determine the safe correction range: According to the specific conditions of the patient, such as the severity of scoliosis, bone age development status, muscle flexibility, etc., determine the maximum safe deformation range of each part during the correction process. This includes:

[0112] The maximum correction angle of each spinal segment: Consider the change range of the physiological curvature and rotation angle of the spine.

[0113] The bearing limit of the ribs and hip bones: Evaluate the maximum pressure that the bone parts can withstand.

[0114] The pressure threshold of soft tissues: Analyze the pressure distribution of soft tissues during deformation to ensure that tissue damage will not be caused.

[0115] Through the above steps, a comprehensive human body correction model is established, and the safe deformation range of each part during the correction process is clarified. This model can not only accurately describe the patient's anatomical structure but also provide an important reference basis for the subsequent orthosis design.

[0116] Step S40: Obtain the preset orthosis 3D model and calculate multiple groups of correction data using finite element analysis

[0117] The purpose of this step is to calculate multiple groups of correction data based on the preset orthosis 3D model through finite element analysis, providing a basis for the subsequent orthosis optimization. The specific implementation method is as follows:

[0118] 1. Obtain the preset orthosis 3D model: According to clinical use experience, prepare an initial orthosis 3D model. This model needs to include geometric and physical parameters such as the overall shape, thickness distribution, and material properties of the orthosis.

[0119] 2. Wear the orthosis on the human body correction model: Register and combine the human body correction model established in step S30 with the preset orthosis 3D model to simulate the actual situation of the orthosis worn on the patient.

[0120] 3. Conduct finite element analysis and calculation: Use finite element analysis technology to calculate various indicators of the orthosis on the human body during the wearing state, including:

[0121] Pressure distribution: Evaluate the contact pressure of the orthosis on each part of the human body.

[0122] Correction moment: Calculate the moment exerted by the correction force on each spinal segment.

[0123] Frictional force: Analyze the frictional force between the orthosis and the human body.

[0124] Spinal force: Evaluate the mechanical load borne by each segment of the spine during the correction process.

[0125] Intervertebral disc pressure: Calculate the pressure change of the intervertebral disc during the correction process.

[0126] Muscle stretch: Analyze the degree of muscle deformation during the correction process.

[0127] Soft tissue deformation: Evaluate the deformation of soft tissues during the correction process.

[0128] 4. Calculate multiple sets of correction data: By adjusting the geometric parameters and material properties of the orthosis, such as shape, thickness, stiffness, etc., repeat the finite element analysis calculation to obtain the calculation results under multiple different correction parameters. These data will provide a basis for the subsequent optimization of the orthosis.

[0129] Through the above steps, based on the preset orthosis model, it is possible to calculate multiple sets of correction data using finite element analysis technology, providing important engineering references for the optimal design of the orthosis. These data cover key indicators such as correction effect, comfort, weight, and durability, laying a foundation for the subsequent optimization of orthosis parameters.

[0130] Step S50: Optimize the shape, thickness distribution, and material properties of the orthosis using a genetic algorithm

[0131] The purpose of this step is to use a multi-objective optimization algorithm to optimize the geometric shape, thickness distribution, and material properties of the orthosis to achieve ideal correction effect, comfort, weight, and durability. The specific implementation method is as follows:

[0132] 1. Define the optimization objective function: According to the multiple sets of correction data calculated in step S40, with the correction effect, comfort, orthosis weight, and durability as the objectives, establish a multi-objective fitness function:

[0133] F = w1E total + w2C total + w3(1 - W score ) + w4D total

[0134] where E total , C total , W score and D total represent the correction effect, comfort, weight score, and durability score respectively, and w1 to w4 are the corresponding weight coefficients.

[0135] 2. Select the optimization algorithm: Since the orthosis design problem has the characteristics of multi-objective optimization, a genetic algorithm is adopted here for optimization. The genetic algorithm is a stochastic search algorithm based on the principle of biological evolution and can effectively solve complex multi-objective optimization problems.

[0136] 3. Encoding and initialization: Encode the parameters such as the geometry, thickness distribution, and material properties of the orthosis into the gene sequence of the chromosome. According to the initial orthosis model, randomly generate an initial population.

[0137] 4. Fitness evaluation: For each individual in the population (i.e., the orthosis design scheme), calculate its fitness value, which is the value of the above multi-objective fitness function F. The higher the fitness value, the better the design scheme.

[0138] 5. Selection and genetic operations: According to the fitness value, use the roulette wheel selection operator to select individuals for crossover and mutation operations to generate a new generation of population. The crossover operation can combine the excellent genes of different individuals, and the mutation operation can introduce new design schemes.

[0139] 6. Termination condition and output: Repeat steps 4 and 5 until the preset termination condition is reached, such as the number of generations of evolution reaches the upper limit or the fitness converges. Finally, output the individual with the highest fitness, which is the optimized orthosis design parameter.

[0140] Through the above genetic algorithm optimization process, it is possible to find the best balance among multiple objectives such as correction effect, comfort, weight, and durability, and obtain an optimized orthosis design scheme that meets various requirements. This provides an important basis for subsequent parameter calculation and sample production.

[0141] Step S60: Modify the 3D model of the orthosis according to the optimized correction parameters and perform the second round of finite element analysis

[0142] The purpose of this step is to modify the 3D model of the orthosis according to the optimized correction parameters obtained in step S50 and perform the second round of finite element analysis to verify the optimization effect. The specific implementation method is as follows:

[0143] 1. Modify the 3D model of the orthosis: Apply the optimized correction parameters obtained in step S50, such as shape, thickness distribution, material properties, etc., to the preset 3D model of the orthosis to generate a modified orthosis model. This process can use computer-aided design (CAD) software for parametric modeling.

[0144] 2. Wear the orthosis on the human correction model again: Similar to step S40, register and combine the modified 3D model of the orthosis with the human correction model constructed in step S30 to simulate the actual situation of wearing the orthosis on the patient.

[0145] 3. Conduct the second round of finite element analysis: Using finite element analysis technology, recalculate various indicators of the modified orthosis on the human body in the wearing state, including pressure distribution, correction moment, spinal stress, intervertebral disc pressure, muscle stretch, and soft tissue deformation, etc.

[0146] 4. Verify the optimization effect: Compare the results of the second round of finite element analysis with the initial results in step S40 to evaluate the improvement of the optimized orthosis in various key indicators. If the optimization effect meets the requirements, the next step can be entered; if further optimization is still needed, step S50 can be returned to adjust the optimization objective function or genetic algorithm parameters and repeat the optimization iteration.

[0147] Through this step, not only the 3D model of the orthosis is modified according to the optimized parameters, but also the optimization effect is verified by finite element analysis to ensure that all performance indicators reach the ideal level. This lays a solid foundation for the parameter calculation and sample production in the subsequent steps.

[0148] Step S70: Calculate each parameter of the scoliosis orthosis according to the optimal correction parameters

[0149] The purpose of this step is to calculate the specific design parameters of the scoliosis orthosis based on the optimal correction parameters obtained in step S60, providing a basis for sample production. The specific implementation method is as follows:

[0150] 1. Overall shape of the orthosis:

[0151] Based on the patient's human body correction 3D model constructed in step S30 and combined with the optimal correction angle parameters obtained in step S50, use the B-spline surface fitting algorithm to generate the basic contour of the orthosis.

[0152] Adopt surface optimization technology to ensure that the shape of the orthosis matches the patient's body shape and at the same time achieve the ideal correction effect.

[0153] Considering the patient's activity needs, while ensuring the correction effect, optimize the shape of the orthosis in key parts (such as under the armpit, buttocks, etc.) to improve comfort.

[0154] 2. Thickness distribution:

[0155] According to the finite element analysis results in steps S40 and S60, determine the stress conditions borne by each part of the orthosis.

[0156] Appropriately increase the thickness in the high-stress area and reduce the thickness in the low-stress area to optimize the weight distribution.

[0157] Adopt a gradient thickness design to ensure a smooth transition between each part of the orthosis and avoid stress concentration.

[0158] Adjust the overall thickness range of the orthosis in combination with the patient's weight and activity level.

[0159] 3. Material selection:

[0160] Select a suitable main material, such as polyethylene, carbon fiber composite material, etc., according to the stiffness requirements of the optimal correction parameters in step S50.

[0161] Select soft and breathable cushioning materials at pressure points and friction areas to improve comfort.

[0162] Consider the patient's skin sensitivity and select hypoallergenic materials.

[0163] Select a suitable surface treatment or coating material according to the durability requirements.

[0164] 4. Pressure point location:

[0165] Determine the positions of the main pressure points of the orthosis based on the pressure distribution data in steps S40 and S60.

[0166] Consider the patient's bone protrusions and sensitive areas, and adjust the pressure point positions to avoid discomfort.

[0167] Design a pressure dispersion structure, such as protrusions or cushions, to optimize the pressure distribution.

[0168] 5. Orthotic force application points:

[0169] Determine the positions where the main orthotic forces are applied based on the type and degree of the patient's scoliosis.

[0170] Consider the three-point pressure principle and design the direction and magnitude of the orthotic force.

[0171] Adjust the specific positions of the orthotic force application points according to the patient's muscle strength and flexibility.

[0172] 6. Support structure design:

[0173] Design the main support structure of the orthosis according to the stiffness requirements of the optimal parameters in step S50.

[0174] Add reinforcing ribs or support bars in high-stress areas to improve the overall strength.

[0175] Design an adjustable support structure to adapt to the patient's growth and correction progress.

[0176] 7. Ventilation hole layout:

[0177] Determine the areas where ventilation needs to be increased based on the results of the thermal comfort analysis in steps S40 and S60.

[0178] Design the size, shape, and distribution of the ventilation holes to maximize the ventilation effect while ensuring the structural strength.

[0179] Consider the patient's activity patterns and increase the ventilation design in areas with high activity levels.

[0180] 8. Position of the fixing strap:

[0181] Determine the position of the main fixing strap based on the point of application of the corrective force and the pressure distribution.

[0182] Design the width and angle of the fixing strap to ensure the stability and comfort of the orthosis.

[0183] Consider the patient's daily wearing and removal needs and optimize the layout of the fixing strap for easy operation.

[0184] Through the above steps, based on the optimal correction parameters obtained in step S60, calculate the various design parameters of the scoliosis orthosis, providing a detailed technical basis for subsequent sample production. These parameters cover key design elements such as the overall shape of the orthosis, thickness distribution, material selection, pressure point position, point of application of the corrective force, support structure, ventilation hole layout, and position of the fixing strap.

[0185] Step S80: Produce an orthosis sample based on the calculated parameters and conduct testing and fine-tuning

[0186] The purpose of this step is to produce a preliminary orthosis sample based on the optimal correction parameters calculated in step S70, conduct actual testing and feedback, and finally determine the target parameters of the scoliosis orthosis.

[0187] The specific implementation method is as follows:

[0188] 1. Produce an orthosis sample:

[0189] Based on the various parameters calculated in step S70, use manufacturing technologies such as 3D printing and vacuum forming to produce a physical orthosis sample.

[0190] Ensure that the structure, shape, thickness distribution, material properties, etc. of the sample meet the design requirements.

[0191] 2. Patient trial fitting and testing:

[0192] Invite the target patient to try on the produced orthosis sample and observe and record the patient's wearing feedback.

[0193] Evaluate the fit, stability, degree of activity limitation, etc. of the orthosis on the patient.

[0194] Collect the patient's subjective evaluations on aspects such as the correction effect, comfort, and weight perception.

[0195] 3. Clinical evaluation:

[0196] Invite professional clinicians to evaluate the trial - worn samples, including correction effect, pressure distribution, impact on physiological functions, etc.

[0197] Combine the professional opinions of doctors to further optimize and improve the design of the samples.

[0198] 4. Parameter fine - tuning:

[0199] Based on the comprehensive patient feedback and clinical evaluation results, fine - tune the orthosis parameters calculated in step S70.

[0200] According to the actual usage situation, adjust the key design parameters of the orthosis, such as shape, thickness distribution, material properties, pressure point positions, etc.

[0201] Ensure that the final design scheme can meet the correction needs of patients, while improving comfort and user experience.

[0202] 5. Determine the target parameters:

[0203] After multiple rounds of trial - wearing and optimization, obtain the final orthosis design parameters that meet various requirements.

[0204] These parameters will be used as the target parameters of the scoliosis orthosis for manufacturing the final product.

[0205] Through this step, combine computer - aided design with actual patient trial - wearing, continuously optimize and fine - tune various parameters of the orthosis, ensure that the final product can meet the individual needs of patients, and achieve ideal performance in terms of correction effect, comfort, weight, etc. This process reflects the engineering design concept of combining computer - aided design with clinical practice.

[0206] In summary, the scoliosis orthosis design method proposed by the present invention makes full use of technical means such as computer - aided design, finite element analysis, genetic algorithm optimization, etc., and systematically solves the multi - objective optimization problem in orthosis design. This method can not only generate a 3D model of the orthosis that meets the needs of patients according to their individual characteristics, but also finally determine the optimal design scheme that meets the requirements of correction effect, comfort, weight and durability through sample testing and parameter fine - tuning. This design method provides strong technical support for the personalized manufacturing of scoliosis orthoses.

[0207] Specifically, the principle of the present invention is: fully integrating a number of cutting - edge technologies such as computer - aided design, medical image processing, finite element analysis and intelligent optimization algorithms, and can effectively solve the problems existing in the existing orthosis design.

[0208] First, the present invention utilizes the patient's body scan and medical image data to construct a three-dimensional model that accurately describes the patient's anatomical structure through steps such as three-dimensional reconstruction, registration, and optimization. Among them, the body surface model can capture the patient's individual surface characteristics, while the bone model provides detailed information on internal structures such as the spine. These refined three-dimensional models lay a reliable foundation for subsequent orthosis design. In contrast, existing orthosis designs mostly rely on empirical anthropometric data and cannot fully reflect the individual needs of patients.

[0209] Secondly, the present invention adopts finite element analysis technology to simulate the load conditions of the orthosis on various parts of the human body in the wearing state. By calculating indicators such as pressure distribution, moment, and stress, the impact of the orthosis on the patient's body can be comprehensively evaluated. These analysis results can not only provide a basis for the correction effect but also provide a reference for optimizing performance indicators such as comfort and durability. Compared with the orthosis designed solely based on experience before, the solution of the present invention can more accurately predict and evaluate its performance.

[0210] Finally, the present invention uses a genetic algorithm to perform multi-objective optimization on parameters such as the geometric shape, thickness distribution, and material properties of the orthosis. By establishing a fitness function with the correction effect, comfort, weight, and durability as the objectives, the genetic algorithm can find the best balance among these indicators and design an optimized orthosis that meets the patient's needs. This intelligent optimization design method overcomes the limitations of traditional empirical design and provides strong technical support for the personalized customization of orthoses.

[0211] In summary, the technical solution adopted by the present invention meets the requirements of scoliosis correction treatment. By accurately describing the patient's anatomical structure, comprehensively evaluating the performance of the orthosis, and intelligently optimizing design parameters, etc., a customized orthosis that can not only effectively correct spinal deformities but also improve the patient's usage experience can be designed. This computer-aided design method provides a more personalized and high-performance solution for scoliosis correction treatment, helping to improve the correction effect and the patient's quality of life.

[0212] Since the present invention involves some calculations, for a better understanding and implementation of the present invention, the following provides a more detailed description of the specific implementation manner of the present invention in combination with specific formulas:

[0213] Step S10: Establish a 3D model of the patient's body surface based on the patient's body scan 3D image

[0214] The purpose of this step is to establish a three-dimensional model that accurately describes the shape of the patient's body surface based on the patient's actual body scan data. The specific implementation manner is as follows:

[0215] First, obtain the point cloud or mesh data describing the surface shape from the patient's body scan process. Let the point cloud data set be where p i =(x i , y i , z i ) represents the three-dimensional coordinates of the i-th point. The mesh data can be expressed as where v j =(x j , y j , z j ) is the coordinate of the j-th vertex, and f k is the vertex index set of the k-th face.

[0216] Due to the possible problems of noise or missing data in the actual scanning process, data preprocessing is required. For the point cloud data a filter based on covariance analysis can be used for sampling and smoothing. For the mesh data an algorithm based on Laplacian smoothing can be used for surface smoothing.

[0217] Next, a standard three-dimensional human body surface model matching the patient's basic information (such as gender, age, height, etc.) needs to be prepared. This standard model can be constructed by collecting a large amount of anthropometric data and using technical means such as mesh generation and surface reconstruction, denoted as

[0218] Then, use a non-rigid registration algorithm to match and deform the preprocessed patient scan data or with the standard model . Here, an algorithm based on the Iterative Closest Point (ICP) can be used, and its objective function is:

[0219]

[0220] where R and t represent the rotation matrix and translation vector respectively. By iteratively optimizing these two parameters, the distance error between the patient scan data and the standard model is minimized.

[0221] Finally, combined with human anatomy knowledge, further optimize the model details. For example, a surface fitting method can be used to reconstruct the surface of the deformed model into a smooth three-dimensional surface to accurately describe the actual human body surface shape of the patient. Let the surface equation be, where N i，p (u) and N j，q (v) are the B-spline basis functions in the u and v directions respectively, and P i，j is the control point coordinate. By adjusting the control point position and weight, the surface can be made to fit the deformed mesh model to the greatest extent.

[0222] Through the above steps, a three-dimensional model that accurately describes the surface shape can be established based on the actual human body scan data of the patient. This model lays the foundation for the subsequent construction of the bone model and the establishment of the human body correction model.

[0223] Step S20: Establish a 3D bone model of the patient based on the X-ray or CT scan data of the patient

[0224] The purpose of this step is to construct a three-dimensional model that accurately describes the bone structure based on the medical image data of the patient. The specific implementation method is as follows:

[0225] First, extract the three-dimensional information describing the bone structure from the X-ray films or CT scan data of the patient. Let these medical image data be which can be represented as a three-dimensional grayscale image.

[0226] Then, it is necessary to segment the original image data to extract the individual bone regions. This can be achieved by using a threshold-based method or an algorithm based on region growing. Starting from the seed points, the bone regions are constructed according to the gray-scale similarity.

[0227] Next, prepare a standard three-dimensional human bone model that matches the basic information of the patient, which can also be constructed by collecting a large amount of bone measurement data and using technical means such as mesh generation and surface reconstruction.

[0228] Then, use a registration algorithm based on feature points or surfaces to match and deform the segmented patient bone data with the standard bone model The objective function can be:

[0229]

[0230] where b i is the segmented bone point cloud, is the vertex of the standard model, and are the normal vectors of the bone point cloud and the model surface respectively, and λ is the weight coefficient for normal vector matching. By optimizing the rigid body transformation parameters R and t, the two are made to coincide as much as possible in terms of position, orientation, and normal vector.

[0231] Finally, combined with bone anatomy knowledge, further optimize the model details. For example, the method of surface reconstruction can be used to reconstruct the surface of the deformed standard model into a smooth three-dimensional surface to accurately describe the actual bone structure of the patient. The method of B-spline surface fitting can also be used to optimize the surface shape by adjusting the control points.

[0232] Through the above steps, a three-dimensional model that accurately describes the patient's bone structure can be established based on the medical image data of the patient. This model provides important geometric information for the subsequent establishment of the human body correction model.

[0233] Step S30: Integrate the human body surface 3D model and the bone 3D model into a human body correction model and determine the safety range

[0234] The purpose of this step is to integrate the human body surface model and the bone model constructed in steps S10 and S20 into a comprehensive human body correction model and determine the safety range of this model during the correction process. The specific implementation method is as follows:

[0235] First, take the human body surface three-dimensional model obtained in step S10 and the bone three-dimensional model obtained in step S20 for registration and integration to generate a complete human body correction three-dimensional model Here, the method of rigid body transformation can be adopted, and the objective function is:

[0236]

[0237] where s i is the point on the surface model, is the vertex on the bone model, and are the normal vectors of the surface model and the bone model respectively, and λ is the weight coefficient for normal vector matching. By optimizing the rigid body transformation parameters R and t, the two models are made to fit as closely as possible in terms of position, attitude, and normal vector.

[0238] Then, for the integrated human body correction model combine information such as the degree of scoliosis, bone age development status, and muscle flexibility of the patient to determine the safe deformation range of each part during the correction process. Specifically, it includes:

[0239] 1. The maximum correction angle of each segment of the spine Consider the change range of the physiological curvature and rotation angle of the spine to ensure that excessive deformation will not occur.

[0240] 2. The bearing limit of the ribs and hip bones Evaluate the maximum pressure that the bone part can withstand to avoid damage caused by stress concentration.

[0241] 3. The pressure threshold P of soft tissues T : Analyze the pressure distribution of soft tissues during deformation to ensure that it does not exceed the bearing capacity of the tissue and cause discomfort.

[0242] Through the above steps, a comprehensive human body correction model is established, and the safe deformation range of each part during the correction process is determined. This provides an important reference basis for the subsequent orthosis design.

[0243] Step S40: Obtain a preset orthosis 3D model and calculate multiple sets of correction data using finite element analysis

[0244] The purpose of this step is to calculate multiple sets of correction data through finite element analysis based on the preset orthosis three-dimensional model, providing a basis for subsequent orthosis optimization. The specific implementation method is as follows:

[0245] First, prepare an initial orthosis three-dimensional model This model includes parameters such as the overall shape, thickness distribution, and material properties of the orthosis.

[0246] Then, register and combine the human body correction model constructed in step S30 with the preset orthosis model to simulate the actual situation of the orthosis worn on the patient. The method of rigid body transformation can be used, and the objective function is:

[0247]

[0248] where s i is the surface point of the human body correction model, is the vertex of the orthosis model, and are the normal vectors of the two models respectively, and λ is the weight coefficient for normal vector matching. By optimizing the rigid body transformation parameters R and t, the orthosis can best fit the human body surface.

[0249] Next, use finite element analysis technology to calculate various indicators exerted by the orthosis on the human body in the worn state, including:

[0250] 1. Pressure distribution P(x, y): Evaluate the contact pressure of the orthosis on various parts of the human body.

[0251] 2. Correction moment M c : Calculate the moment exerted by the correction force on each segment of the spine.

[0252] 3. Friction force F f : Analyze the friction force between the orthosis and the human body.

[0253] 4. Spinal force Evaluate the mechanical load borne by each segment of the spine during the correction process.

[0254] 5. Intervertebral disc pressure P disc : Calculate the pressure change of the intervertebral disc during the correction process.

[0255] 6. Muscle stretching ε m : Analyze the degree of muscle deformation during the correction process.

[0256] 7. Soft tissue deformation δ t : Evaluate the deformation of soft tissues during the correction process.

[0257] By adjusting the geometric parameters and material properties of the orthosis model, finite element analysis results under multiple different design schemes can be obtained. These data will provide a key basis for the subsequent optimization of the orthosis.

[0258] Step S50: Optimize the shape, thickness distribution, and material properties of the orthosis using a genetic algorithm

[0259] The purpose of this step is to use a multi-objective optimization algorithm to optimize the geometric shape, thickness distribution, and material properties of the orthosis to achieve ideal correction effects, comfort, weight, and durability. The specific implementation method is as follows:

[0260] First, based on the multiple sets of correction data calculated in step S40, define the following multi-objective fitness function:

[0261] F = w1E total + w2C total + w3(1 - W score ) + w4D total

[0262] The meanings and calculation methods of each index are as follows:

[0263] 1. Correction effect E total :

[0264] Degree of Cobb angle improvement

[0265] Degree of spinal rotation correction

[0266] Improvement of body shape symmetry

[0267]

[0268] Long-term correction stability

[0269] Comprehensive correction effect score E total = w C E C + W R E R + w S E S + w L E L

[0270] 2. Comfort C total :

[0271] Pressure distribution uniformity

[0272] Contact area ratio

[0273] Soft tissue deformation degree

[0274] Ventilation and thermal comfort

[0275] Range of motion limitation

[0276] Comprehensive comfort score C total = w U U P + w R R A + w D (1 - D T ) + w V V T + w M M R

[0277] 3. Weight score W score :

[0278] Total weight

[0279] Weight distribution uniformity

[0280] Impact of weight on daily activities

[0281] Comprehensive weight score

[0282] 4. Durability D total :

[0283] Material fatigue

[0284] Structural strength in high - stress areas

[0285] Deformation after long - term use

[0286] Wear resistance and corrosion resistance R W = exp(-k w t), R C = exp(-k c t)

[0287] Reliability of seams and connection parts

[0288] Comprehensive durability score D total = w F F M + w S S H + w D D L + w W R W + w C R C + w J R J

[0289] Wherein, w C , w R , w S , w L , w U , w R , w D , w V , w M , w T , w U , w I , w F , w S , w D , w W , w C , w J are the weight coefficients of each index, and the sum is 1.

[0290] Next, the genetic algorithm is used to optimize parameters such as the geometric shape, thickness distribution, and material properties of the orthosis. The specific steps are as follows:

[0291] 1. Coding and initialization: Encode the design parameters of the orthosis into the gene sequence of the chromosome and generate the initial population.

[0292] 2. Fitness evaluation: Calculate the fitness value of each individual (i.e., the orthosis design scheme) according to the above multi-objective fitness function F.

[0293] 3. Selection and genetic operations: Use the roulette wheel selection operator to select individuals with high fitness for crossover and mutation to generate a new generation of population.

[0294] 4. Termination condition and output: Repeat steps 2 and 3 until the termination condition (such as the upper limit of the number of evolutionary generations or fitness convergence) is reached, and finally output the individual with the highest fitness, which is the optimized orthosis design parameter.

[0295] Through this step, it is possible to find the best balance among multiple objectives such as correction effect, comfort, weight, and durability, and obtain an optimized orthosis design solution that meets various requirements.

[0296] Step S60: Modify the orthosis 3D model according to the optimized correction parameters and perform the second round of finite element analysis

[0297] The purpose of this step is to modify the three-dimensional model of the orthosis according to the optimized correction parameters obtained in step S50 and perform the second round of finite element analysis to verify the optimization effect. The specific implementation is as follows:

[0298] First, apply the optimized orthosis design parameters obtained in step S50, such as shape, thickness distribution, material properties, etc., to the preset orthosis three-dimensional model to generate the modified orthosis model This process can adopt the method of parametric modeling, and the model can be modified by adjusting the positions of control points, surface thickness functions, etc.

[0299] Then, apply the modified orthosis model again to register and combine with the human body correction model constructed in step S30 to simulate the actual situation of the orthosis worn on the patient. The objective function is also:

[0300]

[0301] Next, adopt the finite element analysis technology to recalculate the various performance indicators of the modified orthosis on the human body in the wearing state, including pressure distribution, correction moment, spinal force, etc. This process is similar to the finite element analysis method in step S40.

[0302] Finally, compare the finite element analysis results before and after optimization to evaluate whether the optimization effect meets the requirements. If there are still problems with the results, it is possible to return to step S50, adjust the optimization objective function or genetic algorithm parameters, and perform the next round of iterative optimization.

[0303] Through this step, not only is the three-dimensional model of the orthosis modified according to the optimized parameters, but also the optimization effect is verified through the second round of finite element analysis, ensuring that all performance indicators reach the ideal level. This lays the foundation for parameter calculation and sample production in the subsequent steps.

[0304] Step S70: Calculate each parameter of the scoliosis orthosis according to the optimal correction parameters

[0305] The purpose of this step is to calculate the specific design parameters of the scoliosis orthosis according to the optimal correction parameters obtained in step S60, providing a basis for sample production. The specific implementation is as follows:

[0306] 1. Overall shape of the orthosis:

[0307] Using the B-spline surface fitting method, based on the geometric shape of the human body correction model in step S30 and the optimal correction angle parameters obtained in step S50, generate the basic contour of the orthosis. The B-spline surface equation is:

[0308]

[0309] By adjusting the control points Pi, j the position and weight of which can make the surface best fit the body shape characteristics of the patient and achieve an ideal correction effect at the same time.

[0310] 2. Thickness distribution:

[0311] According to the finite element analysis results of steps S40 and S60, determine the stress distribution σ(x, y) borne by each part of the orthosis. Adopt the gradient thickness design method, increase the thickness ΔT in the high stress area, thin it in the low stress area, and ensure smooth transition at the same time:

[0312] T(x, y) = T base +ΔT·f(σ(x, y))

[0313] where T base is the base thickness and f(·) is the stress-thickness mapping function.

[0314] 3. Material selection:

[0315] According to the stiffness requirements of the optimal parameters in step S50, select appropriate main materials, such as polyethylene, carbon fiber composite materials, etc. Use soft and breathable cushioning materials at the pressure points and friction areas. At the same time, consider the skin sensitivity of the patient and the durability requirements for long-term use.

[0316] 4. Pressure point positions:

[0317] Adopt the K-means clustering algorithm to determine the positions μ i of the main pressure points of the orthosis according to the pressure distribution P(x, y) in steps S40 and S60:

[0318]

[0319] By optimizing the clustering center μ i , make the sum of the squares of the distances between the points within the same pressure point area and the center the smallest.

[0320] 5. Orthosis force application points:

[0321] Based on the three - point pressure principle, assuming the supporting forces at both ends are F1 and F2, and the distances from the middle correction point are d1 and d2, then the middle correction force F c is:

[0322]

[0323] where d c is the length of the correction force arm. By adjusting the positions and magnitudes of the three - point pressures, an ideal correction effect can be achieved.

[0324] 6. Support structure design:

[0325] According to the stiffness requirements of the optimal parameters in step S50, add reinforcing ribs or support bars in high - stress areas to improve the overall structural strength. At the same time, design an adjustable support structure to adapt to the growth and correction progress of the patient.

[0326] 7. Ventilation hole layout:

[0327] Adopt the Poisson disk sampling algorithm. According to the results of thermal comfort analysis and stress distribution, generate the optimal ventilation hole positions and size distributions on the surface of the orthosis:

[0328]

[0329] where, is the set of positions of existing ventilation holes, and λ is the parameter controlling the density.

[0330] 8. Position of the fixing strap:

[0331] Based on the principal curvature analysis, determine the position of the fixing strap along the direction of the maximum principal curvature K1:

[0332]

[0333] where H and K are the mean curvature and Gaussian curvature respectively. The angle and width of the fixing strap also need to consider the activity requirements of the patient.

[0334] Through the above steps, according to the optimal correction parameters obtained in step S60, calculate the various design parameters of the scoliosis orthosis, providing a detailed technical basis for subsequent sample production.

[0335] Step S80: Make an orthosis sample according to the calculated parameters and conduct tests and fine - tuning

[0336] The purpose of this step is to make a preliminary orthosis sample according to the optimal correction parameters calculated in step S70, conduct actual tests and feedback, and finally determine the target parameters of the scoliosis orthosis. The specific implementation method is as follows:

[0337] First, according to the various parameters obtained in step S70, such as shape, thickness distribution, material properties, etc., use advanced manufacturing technologies such as 3D printing and vacuum forming to produce a physical orthosis sample. Ensure that the structure, shape, thickness distribution, etc. of the sample meet the design requirements.

[0338] Then, invite the target patient to try on the fabricated orthosis sample and observe and record the patient's wearing feedback. It mainly includes the following aspects:

[0339] 1. Fit and stability: Evaluate the fitting degree and fixation of the orthosis on the patient.

[0340] 2. Degree of activity limitation: Analyze the impact of the orthosis on the patient's daily activities.

[0341] 3. Correction effect: Observe the patient's spinal state and body shape symmetry after correction.

[0342] 4. Comfort: Collect the patient's subjective evaluations on aspects such as pressure perception and weight perception.

[0343] At the same time, also invite professional clinicians to evaluate the trial sample and put forward optimization suggestions. Include professional opinions on aspects such as correction effect, pressure distribution, and impact on physiological functions.

[0344] Finally, based on the comprehensive patient feedback and clinical evaluation results, fine-tune the orthosis parameters calculated in step S70. According to the actual usage situation, adjust key design parameters such as the shape, thickness distribution, material properties, and pressure point positions of the orthosis to ensure that the final design scheme can meet the patient's personalized needs while improving comfort and user experience.

[0345] The specific parameter fine-tuning process is as follows:

[0346] 1. According to the patient feedback, make local adjustments to the overall shape of the orthosis to improve the fit and stability. For example, add protrusions or adjust the curved surface shape at key support points.

[0347] 2. According to the pressure distribution analysis, appropriately adjust the thickness distribution to make the pressure more uniform and avoid discomfort caused by excessive local pressure.

[0348] 3. According to the patient's feedback on weight perception, slightly adjust the overall thickness or use lighter materials to reduce the weight of the orthosis while ensuring strength.

[0349] 4. In response to the feedback on the degree of activity limitation, optimize the adjustability of the support structure and increase the degree of freedom of movement of the orthosis.

[0350] 5. According to the correction effect evaluation, appropriately adjust the action point and magnitude of the correction force to ensure that the ideal correction result can be achieved.

[0351] 6. Combine with the patient's skin sensitivity, select a more comfortable cushioning material, and improve the comfort of long-term wear.

[0352] After multiple rounds of trial fitting and optimization iterations, finally determine the target parameters of the scoliosis orthosis that meet various requirements, providing a basis for subsequent manufacturing.

[0353] Through the above step S80, combine computer-aided design with actual clinical applications, continuously optimize and fine-tune various parameters of the orthosis, ensure that the final product can meet the personalized needs of patients, and achieve an ideal performance level in terms of correction effect, comfort, weight, etc. This process reflects the engineering design concept of the integration of computer-aided design technology and clinical practice.

[0354] In summary, the scoliosis orthosis design method proposed by the present invention makes full use of advanced technical means such as computer-aided design, finite element analysis, and genetic algorithm optimization, and systematically solves the multi-objective optimization problem in orthosis design. This method can generate a three-dimensional model of the orthosis that meets the patient's needs according to the individual characteristics of the patient, and determine the optimal design scheme that meets the requirements of correction effect, comfort, weight, and durability through sample testing and parameter fine-tuning. This computer-aided personalized design method provides important technical support for the customized manufacturing of scoliosis orthoses, and is of great significance for improving the effect of correction treatment and the quality of life of patients.

[0355] The above is only the specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art can easily think of changes or substitutions within the technical scope disclosed by the present invention, and all should be covered by the protection scope of the present invention.

Claims

1. A method for designing a scoliosis orthosis, characterized in that: The following steps are involved: S10, establishing a 3D model of the patient's body surface based on a standard human body surface model that matches the patient's basic information according to the patient's body scan 3D image; S20, establishing a skeletal 3D model of the patient based on the X-ray or CT scan data of the patient and a standard skeletal 3D model of the human body that matches the basic information of the patient; S30, fusing the human body surface 3D model and the skeleton 3D model into a human body correction model, and determining a safety range of the human body correction model, including a maximum correction angle of each spinal segment, a pressure limit of ribs and hip bones, and a pressure threshold of soft tissue; S40, obtaining a preset 3D model of the orthosis, wearing it outside the human body correction model, and calculating multiple sets of correction data using finite element analysis, including pressure distribution of the orthosis on the human body, correction torque, friction, and stress conditions of each spinal segment, intervertebral disc pressure, muscle stretching degree, and soft tissue deformation degree; S50, using the multiple sets of correction data as input variables, correction effect, comfort, orthosis weight and durability as multi-objective fitness functions, using a genetic algorithm to optimize the shape, thickness distribution and material properties of the orthosis, and obtaining multiple sets of optimized correction parameters; S60, modifying the 3D model of the orthosis according to the optimized correction parameters, and performing a second round of finite element analysis to verify the optimization effect and obtain the optimal correction parameters; S70, calculating parameters of the scoliosis orthosis according to the optimal correction parameters, including the overall shape, thickness distribution, material selection, pressure point location, correction force application point, support structure design, ventilation hole layout, and fixation belt location of the orthosis; S80, making a sample of the scoliosis orthosis according to the parameters of the scoliosis orthosis, testing the wearing effect on patients, and fine-tuning the parameters of the scoliosis orthosis according to patient feedback and clinical evaluation to obtain target parameters of the scoliosis orthosis for making the scoliosis orthosis.

2. The method for designing a scoliosis orthosis according to claim 1, characterized in that: The patient's basic information includes bone age, muscle fat value, body flexibility, tolerance of orthopedic strength, degree of scoliosis, degree of spinal rotation, growth rate, age, gender, and weight.

3. The method for designing a scoliosis orthosis according to claim 1, characterized in that: The correction effect is used to evaluate the improvement of the Cobb angle, the correction of spinal rotation, and the improvement of body shape symmetry.

4. The method for designing a scoliosis orthosis according to claim 1, characterized in that: The comfort index is used to assess the uniformity of pressure distribution, the ratio of contact area to total surface area, the degree of soft tissue deformation, ventilation and thermal comfort, and the degree of restriction of range of motion.

5. The method for designing a scoliosis orthosis according to claim 1, characterized in that: The orthosis weight is used to calculate the volume of the orthosis based on the 3D model, calculate the total weight in combination with the density of the selected material, evaluate the uniformity of weight distribution, and evaluate the impact of weight on the patient's daily activities.

6. The method for designing a scoliosis orthosis according to claim 1, characterized in that: The durability is used to perform material fatigue analysis, evaluate the structural strength of high stress areas, simulate deformation after long-term use, consider the wear resistance and corrosion resistance of the material, and evaluate the reliability of joints and connections.

7. The method for designing a scoliosis orthosis according to claim 1, characterized in that: The standard human body surface model and skeleton model are constructed by collecting a large amount of human body measurement data and using the technical means of mesh generation and surface reconstruction.

8. The method for designing a scoliosis orthosis according to claim 1, characterized in that: The overall shape is designed using a B-spline surface fitting algorithm, which is used to achieve the best match between the orthosis contour and the patient's body shape by adjusting the control point positions and weights.

9. The method for designing a scoliosis orthosis according to claim 1, characterized in that: The thickness distribution is designed by using a gradient thickness design method, increasing the thickness in high stress areas and reducing the thickness in low stress areas, while ensuring smooth transitions between various parts.

10. The method for designing a scoliosis orthosis according to claim 1, characterized in that: The design of the vent layout adopts a Poisson disk sampling algorithm to optimize the size, shape and distribution of the vents according to the local stress distribution and temperature field.

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