Biomechanical evaluation method and system for bone defect repair implant

Abstract

The invention relates to the technical field of bone implantation, and discloses a biomechanical evaluation method and system for a bone defect repair implant, and the method comprises the steps: constructing a human muscle-bone system biomechanical model and a three-dimensional digital model of the bone defect repair implant; through a finite element analysis method, the stress conditions of the bone defect repair implant in different gaits and movement modes are calculated, and the stress conditions of the implant in the actual service process are simulated; and calculating the performance of the implant under the simulated stress, and adjusting the design parameters of the implant. By combining dynamics calculation, bone regeneration process simulation, nano computed tomography image three-dimensional reconstruction and structure optimization, a bone repair implant biomechanical adaptability evaluation mechanism is established, and a comprehensive evaluation system integrating system dynamics calculation and bone healing process analysis is designed. The bone repair and regeneration process and the acting force change process are simulated, the effect of mechanical stimulation on bone regeneration is revealed, and comprehensive evaluation of the structure, the mechanical property, the environmental adaptability and the service life of the implant is achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of bone implantation, and in particular to a biomechanical evaluation method and system for a bone defect repair implant. Background Art

[0002] Faced with the large amount of bone loss caused by complex reasons such as trauma, osteomyelitis, congenital pseudoarthrosis and resection of malignant bone tumors, the repair and treatment of large bone defects constitutes a major challenge in the field of orthopedics. Such defects not only affect the patient's limb function and quality of life, but are also accompanied by high-risk postoperative complications, including but not limited to failure of the bone fixation device (such as breakage), periprosthetic fracture, loosening and breakage, poor bone absorption and bone integration disorders. Improper treatment can easily lead to disability or deformity of the patient, seriously reducing his quality of life.

[0003] At present, despite the continuous advancement of medical technology, the systematic evaluation mechanism for the preoperative adaptability of bone defect repair implants (such as artificial bones and bone substitute materials) is still weak, especially the lack of in-depth research on the adaptability and reliability of implants in the individual's internal environment from the perspective of the human body's overall motor function (such as walking gait and daily activity patterns).

[0004] The lack of this assessment directly limits doctors’ ability to accurately predict the effectiveness of implants, making it difficult to effectively avoid postoperative risks and reduce the incidence of complications. Summary of the invention

[0005] In view of the deficiencies in the prior art, the present invention proposes a biomechanical evaluation method and system for bone defect repair implants to solve the above technical problems.

[0006] In a first aspect, a biomechanical evaluation method for a bone defect repair implant is provided, comprising:

[0007] Construct a three-dimensional digital model that includes a biomechanical model of the human musculoskeletal system and an implant for bone defect repair;

[0008] Finite element analysis is used to simulate the stress of bone defect repair implants in different gait and motion modes, so as to simulate the stress of implants in actual service.

[0009] The simulation calculates the stress distribution, deformation and fatigue life of the implant under simulated force, and adjusts the design parameters of the implant until the preset standards are met.

[0010] Furthermore, the construction of the three-dimensional digital model includes:

[0011] Collect the actual size of the bone defect, the complete size of the bone where the defect is located, and the size data and material properties of the implant;

[0012] A three-dimensional model of the interaction between the implant and the surrounding bone tissue was constructed using three-dimensional modeling software based on the collected data and combined with the medical imaging data of the bone defect.

[0013] Furthermore, the force simulation includes:

[0014] According to the kinematics and inverse dynamics simulation results of the human musculoskeletal system, the actual stress conditions of the bone defect are determined, and reasonable boundary conditions and loading conditions are set;

[0015] Simulate implant stresses under static and dynamic loading, including different gait and movement patterns.

[0016] Furthermore, the biomechanical properties of the implant are evaluated as follows:

[0017] Analyze the interface bonding strength between the implant and the surrounding bone tissue;

[0018] Evaluate the stress distribution, deformation, fatigue life, stability and durability of implants during long-term use.

[0019] Second, a biomechanical evaluation system for bone defect repair implants is provided, including:

[0020] 3D modeling module, used to build 3D digital models of the human musculoskeletal system and implants;

[0021] A finite element analysis module, used for performing mechanical loading simulation on the three-dimensional digital model;

[0022] Performance evaluation module, used to evaluate the biomechanical performance of implants under simulated forces;

[0023] The optimization design module is used to adjust the design parameters of the implant according to the evaluation results.

[0024] Furthermore, the three-dimensional modeling module includes:

[0025] A data acquisition unit, used to collect the actual size of the bone defect, the complete size of the bone where the defect is located, and the size data and material properties of the implant;

[0026] The modeling unit is used to construct a biomechanical model of the human musculoskeletal system and a three-dimensional digital model of a bone defect repair implant based on the collected data.

[0027] Furthermore, the finite element analysis module includes:

[0028] Boundary condition setting unit, used to set reasonable boundary conditions and loading conditions;

[0029] The mechanical loading simulation unit is used to simulate the stress conditions of implants under static and dynamic loads.

[0030] Furthermore, the performance evaluation module includes:

[0031] Interface bonding strength evaluation unit, used to analyze the interface bonding strength between the implant and the surrounding bone tissue;

[0032] Stability assessment unit, used to evaluate the stability of implants during long-term use;

[0033] Durability Assessment Unit, used to assess the durability of implants during long-term use.

[0034] Furthermore, the optimization design module includes:

[0035] a design parameter adjustment unit, used for adjusting the design parameters of the implant according to the evaluation results;

[0036] The optimization result verification unit is used to verify whether the optimized implant meets the preset biomechanical performance standards.

[0037] The invention adopting the above technical solution has the following advantages:

[0038] The present invention combines dynamic calculation, bone regeneration process simulation, nano-computed tomography image three-dimensional reconstruction and structural optimization to establish a biomechanical adaptability evaluation mechanism for bone repair implants, and designs a comprehensive evaluation system that integrates system dynamic calculation and bone healing process analysis. The bone repair regeneration process and the force change history are simulated to reveal the effect of mechanical stimulation on bone regeneration, and to achieve a comprehensive evaluation of the implant's structure, mechanical properties, environmental adaptability and service life. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] In order to more clearly illustrate the specific implementation of the present invention, the following will briefly introduce the drawings required for use in the specific implementation. In all the drawings, each element or part is not necessarily drawn according to the actual scale.

[0040] Figure 1 A flow chart of the biomechanical evaluation method for a bone defect repair implant of the present invention;

[0041] Figure 2 Creating a flow chart for the biomechanical model of the human musculoskeletal system in the biomechanical evaluation method of the bone defect repair implant of the present invention;

[0042] Figure 3 This is a diagram of the simulation calculation steps of different gaits and motion patterns in the biomechanical evaluation method of the bone defect repair implant of the present invention. DETAILED DESCRIPTION

[0043] The following embodiments of the technical solution of the present invention are described in detail in conjunction with the accompanying drawings. The following embodiments are only used to more clearly illustrate the technical solution of the present invention, and are therefore only used as examples, and cannot be used to limit the protection scope of the present invention.

[0044] It should be noted that, unless otherwise specified, the technical terms or scientific terms used in this application should be the common meanings understood by technicians in the field to which the present invention belongs. The terms "first", "second", etc. in the specification and claims of the embodiments of the present disclosure and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the data used in this way can be interchanged where appropriate, so as to implement the embodiments of the present disclosure described here. In addition, the terms "including" and "having" and any of their variations are intended to cover non-exclusive inclusions. Unless otherwise specified, the term "multiple" means two or more. In the embodiments of the present disclosure, the character " / " indicates that the objects before and after are in an "or" relationship. For example, A / B means: A or B. The term "and / or" is a description of the association relationship of objects, indicating that there can be three relationships. For example, A and / or B means: A or B, or, A and B. The term "corresponding" can refer to an association relationship or a binding relationship, and A and B correspondingly refer to an association relationship or a binding relationship between A and B.

[0045] like Figure 1 to Figure 3 As shown, the biomechanical evaluation method of a bone defect repair implant of the present invention comprises:

[0046] Step S01, constructing a three-dimensional digital model including a biomechanical model of the human musculoskeletal system and a bone defect repair implant;

[0047] Step S02, using a finite element analysis method, simulating and calculating the stress conditions of the bone defect repair implant under different gait and motion modes, so as to simulate the stress conditions of the implant during actual service;

[0048] Step S03, evaluating the stress distribution, deformation and fatigue life of the implant under simulated stress, and adjusting the design parameters of the implant until the preset standards are met.

[0049] Specifically, by combining dynamic calculation, bone regeneration process simulation, Nano-CT image (nano-computed tomography image) three-dimensional reconstruction and structural optimization, a set of biomechanical adaptability evaluation mechanism for bone repair implants is established, and a comprehensive evaluation system integrating system dynamic calculation and bone healing process analysis is designed. The bone repair regeneration process and the force change history are simulated to reveal the effect of mechanical stimulation on bone regeneration, and to achieve a comprehensive evaluation of the implant's structure, mechanical properties, environmental adaptability and service life.

[0050] In some embodiments, the construction of the three-dimensional digital model includes:

[0051] Collect the actual size of the bone defect, the complete size of the bone where the defect is located, and the size data and material properties of the implant;

[0052] A three-dimensional model of the interaction between the implant and the surrounding bone tissue was constructed using three-dimensional modeling software based on the collected data and combined with the medical imaging data of the bone defect.

[0053] Specifically, the process of creating a biomechanical model of the human musculoskeletal system (taking tibial defect repair evaluation as an example):

[0054] (1) Determination of tibial defect location, structure, and size

[0055] Nano-CT was used to scan the left and right tibia of the patient, and a complete model was established based on the patient's healthy tibia. Based on the principle of left-right symmetry of the human body, a complete model of the damaged tibia was obtained radially. Then, the defect location, size, and structural characteristics of the damaged tibia were determined based on the patient's damaged tibia to provide guidance for the structural design of the proposed repair implant.

[0056] (2) Determination of fixation scheme for bone defect repair implant

[0057] According to the patient's tibia model, defect location and size established by the CT scan image, the corresponding fixation scheme is selected in the system; then, the patient's tibia model, the intended implant and the fixation device are pre-assembled, and the fixation scheme is adjusted and optimized.

[0058] (3) Proposed bone repair implant transfer and fixation

[0059] The patient's left and right tibia models and the biomechanical model of the musculoskeletal system in which the prosthetic implants are loaded are fixed with the fixation device determined in the previous step.

[0060] (4) Establish a biomechanical model of the human musculoskeletal system

[0061] 1) Medical imaging data collection and preprocessing

[0062] CT (computed tomography) and MRI (magnetic resonance imaging) medical imaging technologies are used to obtain high-precision three-dimensional image data of human bones and muscles as the basis for building the model. Secondly, biomechanical parameters such as muscle force, joint torque, and material properties are collected. Then, combined with human anatomy knowledge, the exact position and shape of bones, joints, and muscle tissues are determined.

[0063] 2) Skeleton-muscle geometry modeling

[0064] ① Bone modeling: Based on medical imaging data, the special medical image processing software Mimics is used to perform three-dimensional reconstruction of the injured parts on the left and right sides of the patient and their corresponding healthy bones. The created bone model is adapted using three-dimensional software, and then the processed bone model is imported into AnyBody and assembled. For the healthy bones in other parts, the built-in bone model in AnyBody software is used to adjust the size, shape and position of the bones to ensure consistency with the patient's morphological parameters.

[0065] ② Muscle modeling: Add muscle tissue to the skeletal model based on anatomical knowledge and the patient's muscle morphology; define the starting point, insertion point and path of the muscle to ensure the accuracy of the muscle model; assign material properties and mechanical parameters of the muscle, such as elastic modulus and contractile force.

[0066] ③ Joint modeling: Establish the geometric model of the joint, including the articular surface, joint capsule, and ligament structure; define the range of motion and constraints of the joint to ensure the authenticity of the joint movement.

[0067] 3) Material properties and mechanical parameter settings

[0068] Define material properties: Assign corresponding material properties such as elastic modulus, Poisson's ratio, density to bone, muscle, and joint tissues based on experimental data or literature reports.

[0069] Set mechanical parameters: Set the contraction force of muscles, elastic coefficient of tendons, friction coefficient of joints, etc. These parameters are crucial for simulating the mechanical behavior of the musculoskeletal system.

[0070] 4) Constraint and boundary condition setting

[0071] Set constraints: Set joint constraints (such as hinge constraints and ball joint constraints) according to the actual movement of the human musculoskeletal system.

[0072] Define boundary conditions: Define the boundary conditions of the model, such as external force loading points and fixed points.

[0073] 5) Motion data capture and model optimization

[0074] The collected motion capture data is imported into AnyBody as the input of kinematic simulation; the simulation is run to simulate the kinematic behavior under different gaits and motion modes, and the problems existing in the model are optimized and improved. Then, based on the kinematic simulation, inverse dynamics analysis is performed to calculate muscle forces and joint reaction forces, and these internal body loads are used as input conditions for Abaqus analysis.

[0075] In some embodiments, the force simulation includes:

[0076] According to the kinematics and inverse dynamics simulation results of the human musculoskeletal system, the actual stress conditions of the bone defect are determined, and reasonable boundary conditions and loading conditions are set;

[0077] Simulate implant stresses under static and dynamic loading, including different gait and movement patterns.

[0078] Specifically, the simulation calculation process of different gaits and motion modes is as follows:

[0079] (1) Kinematics and dynamics simulation calculation

[0080] Based on the biomechanical model of the human musculoskeletal system established earlier, in AnyBody, kinematic simulation is first completed to simulate the kinematic behavior in different gaits and motion modes; then, on the basis of the kinematic simulation, inverse dynamics analysis is performed to calculate the muscle force and joint reaction force, and the calculated internal body load is used as the input condition for Abaqus calculation.

[0081] (2) Model conversion and import

[0082] Convert the tibia forces (such as joint reaction forces) calculated in AnyBody into a format that Abaqus can recognize (such as load files). Then, import the tibia geometry model and the complete tibia load calculated in the previous step into Abaqus.

[0083] (3) Meshing and finite element modeling

[0084] Discretize the geometric model into a finite element mesh, and verify the influence of the mesh density and quality on the calculation accuracy; create a tibia finite element model, and define the model's boundary conditions, loading conditions, and contact relationships.

[0085] (4) Material properties and mechanical parameter settings

[0086] Based on experimental data and biomechanical properties of the tibia reported in literature, anisotropic material properties are defined for the tibia. The load file obtained from AnyBody is applied to the corresponding positions in the Abaqus model, and the correct boundary conditions are set.

[0087] (5) Simulation calculation and analysis

[0088] Run the finite element analysis of Abaqus to calculate the stress and strain parameters of the tibia in different gait or motion modes, monitor the analysis process to ensure convergence and the rationality of the results. After the calculation is completed, extract the analysis results, including the stress cloud diagram and strain curve of the tibia.

[0089] (6) Model verification and calibration

[0090] The model simulation results are compared with the existing experimental data to verify the accuracy and reliability of the model, and the model is adjusted and optimized as needed. Secondly, the sensitivity analysis of the key parameters in the model is carried out to analyze the influence of the corresponding parameters on the model results.

[0091] (7) Result analysis and evaluation

[0092] Compare the forces on the tibia in different gaits or movement patterns, and analyze the differences and their causes. Combine medical and biomechanical knowledge to interpret and evaluate the results. Organize the analysis process and data, and write a detailed evaluation report.

[0093] In some embodiments, evaluating the biomechanical properties of the implant comprises:

[0094] Analyze the interface bonding strength between the implant and the surrounding bone tissue;

[0095] Evaluate the stress distribution, deformation, fatigue life, stability and durability of implants during long-term use.

[0096] Specifically, the biomechanical adaptability evaluation and analysis:

[0097] (1) Structural size matching accuracy

[0098] The evaluation of the structural size matching between bone implants and native bone mainly relies on the combination of medical imaging technology, computer-aided design (CAD) and simulation. Through the virtual assembly of the implant, the precise measurement of the implant design accuracy can be achieved. Taking the repair of human tibial defects as an example, the specific evaluation criteria and steps are as follows:

[0099] 1) Medical image acquisition and processing

[0100] step:

[0101] ① Use high-resolution medical imaging technology (CT, MRI) to obtain detailed imaging data of the patient's healthy tibia and damaged tibia.

[0102] ②Use professional medical image processing software to reconstruct the image data in three dimensions and generate a three-dimensional model of the native bone; based on the principle of left-right symmetry, establish a complete model of the damaged tibia.

[0103] Evaluation criteria:

[0104] ① The resolution of the image data should be high enough to accurately reflect the fine structure of the bone.

[0105] ② The accuracy of three-dimensional reconstruction should meet the design requirements, and the error should be controlled within the range of 0.1 to 0.5 mm.

[0106] 2) Implant design

[0107] step:

[0108] ① Design a three-dimensional model of the bone implant in CAD software based on the patient's specific condition and surgical requirements.

[0109] ②During the design process, the shape, size, surface structure and fixation method of the implant need to be considered to ensure compatibility with the native bone.

[0110] Evaluation criteria:

[0111] ①The design of the implant should be based on the three-dimensional model of the native bone to ensure precise matching of shape and size.

[0112] ② The biomechanical principles must be followed during the design process to ensure that the implant can work stably under stress.

[0113] 3) Compatibility assessment

[0114] step:

[0115] ① Overlap and compare the 3D model of the implant with the 3D model of the native bone.

[0116] ② Use software tools to measure and calculate the matching error value between the two.

[0117] Calculation method:

[0118] ① The matching error value is obtained by calculating the distance difference between the two at key points, key surfaces or overall shapes.

[0119] ②The smaller the error value, the higher the matching degree.

[0120] Evaluation criteria:

[0121] ① Depending on the size of the implant, the matching error value is usually controlled within the range of 0.1 to 0.5 mm to ensure accurate matching of the implant.

[0122] ②For key parts or stress-bearing areas, the matching requirements can be appropriately increased.

[0123] (2) Stress shielding assessment

[0124] The stress shielding effect refers to the phenomenon that when the rigidity of the implant is higher than that of the surrounding bone tissue, the implant will bear more stress, while the bone tissue will suffer from osteoporosis or atrophy due to the reduced stress. The present invention adopts a simulation calculation method, taking the human tibia as an example, to evaluate whether the bone implant has stress shielding and the size of the shielding rate, so as to guide the optimal design of the implant. The specific evaluation method and steps are as follows:

[0125] 1) Evaluation criteria

[0126] ① Stress distribution: Based on the tibial stress and strain simulation calculation results in the simulation calculation process of different gait and movement patterns, the stress distribution between the implant and the surrounding bone tissue is evaluated to determine whether there are significant stress concentration or stress reduction areas.

[0127] ② Stress shielding rate: By calculating the change in bone tissue stress before and after the implant, the stress shielding rate is obtained to quantify the degree of stress shielding. The formula for calculating the stress shielding rate can be:

[0128]

[0129] Where η is the stress shielding rate, σ1 is the stress level of bone tissue when the implant is present, and σ2 is the stress level of bone tissue when the implant is not present.

[0130] 2) Evaluation steps

[0131] ①Data collection and preparation

[0132] The steps are the same as those for creating a biomechanical model of the human musculoskeletal system:

[0133] a. Obtain high-resolution medical imaging data (CT, MRI) of patients.

[0134] b. Use medical image processing software to perform three-dimensional reconstruction of the image data and generate a three-dimensional model of the native bone.

[0135] c. Design a 3D model of the implant based on the loss area and size, and determine its material properties and geometric dimensions.

[0136] ② Finite element simulation

[0137] a. Import the 3D model of the implant and native bone into the finite element analysis software.

[0138] b. Set the load conditions for the simulation, including static loads and dynamic loads (such as gait loads).

[0139] c. Assign material properties to the model, such as elastic modulus and Poisson's ratio.

[0140] d. Perform finite element calculation to analyze the stress distribution between the implant and bone tissue.

[0141] ③ Calculation of stress shielding rate

[0142] a. Based on the finite element simulation results, extract the stress data of the bone tissue before and after the implant.

[0143] b. Use the stress shielding rate calculation formula to calculate the stress shielding rate.

[0144] ④Results analysis and evaluation

[0145] a. Analyze the results of finite element simulations and bone biomechanical testing.

[0146] b. Determine whether the implant has stress shielding according to the evaluation criteria.

[0147] c. If stress shielding exists, assess its extent and possible effects on bone tissue.

[0148] ⑤Optimization suggestions

[0149] Based on the evaluation results, recommendations for optimizing the implant design are made, such as adjusting material properties, changing geometric dimensions, or improving fixation methods.

[0150] (3) Risk of implant loosening and fatigue failure under different gait and movement patterns

[0151] When evaluating the loosening and fatigue failure risks of bone implants in different gait and movement patterns, it is necessary to comprehensively consider the biomechanical properties of bone implants, the patient's activity patterns, and the design and material factors of the implants. The specific evaluation methods, processes, and standards are as follows:

[0152] 1) To assess whether the implant is loose, X-ray examinations are usually used clinically to observe the integration of the implant and the surrounding bone tissue, and to check whether the gap increases or the position of the implant changes. For complex cases, CT or MRI can be used to obtain more detailed images to assess the contact between the implant and the bone tissue. Secondly, specific stress tests are performed on the patient, such as applying a certain force around the implant to observe whether there are signs of loosening. Imaging standards for implant loosening: the gap between the implant and the bone tissue exceeds the normal range (such as more than 2mm), or the position of the implant changes significantly.

[0153] 2) Since the system of the present invention is used to assess the loosening risk of implants before surgery, the finite element method is used to simulate and calculate the clinical assessment of implant loosening and fatigue failure, and the loosening simulation calculation is performed simultaneously with the fatigue calculation. Finite element analysis software is used to simulate the stress distribution of the implant under different gait and movement modes, and predict potential fatigue failure areas. The calculation and evaluation idea is: based on the established biomechanical model of the human musculoskeletal system according to the simulation calculation process of different gait and movement patterns.

[0154] By applying reciprocating and cyclic loads to simulate different gaits or movement patterns of the human body, on the one hand, the strain of the implant is analyzed based on the calculation results, and whether the distance between the implant and the native bone tissue exceeds the normal range (such as more than 2mm). If it exceeds the normal range, it is considered that the risk of loosening is relatively high. On the other hand, based on fatigue calculations within a certain period, the stress distribution and strain of the implant are analyzed, and the calculation results are compared with the contact surface pitting severity mark number and the material fatigue life curve (SN curve or ε-N curve) to evaluate the failure risk and possible failure mode of the implant.

[0155] (4) Evaluation of the effect of mechanical stimulation on bone regeneration

[0156] 1) Evaluation purpose and modeling

[0157] The simulation calculation of the effect of mechanical stimulation on the regeneration process of bone implants is a complex process that combines the knowledge of biomechanics, computational mechanics and biomedical engineering. Its purpose is to evaluate the effect of the material and structure of bone implants on promoting the bone regeneration process under the action of external forces.

[0158] The present invention uses the finite element method to simulate the regeneration of bone implants in the in vivo environment, thereby illustrating the individual environmental adaptability of bone implants. Taking the repair of human tibial defects as an example, based on the human musculoskeletal system biomechanical model established by the human musculoskeletal system biomechanical model creation process, the calculated tibial load is used as the input condition for the simulation calculation of the bone regeneration process through simulation calculation of different gaits and movement patterns.

[0159] 2) Bone regeneration mechanism

[0160] The present invention simulates the bone regeneration process and adopts a bone connection model based on the adaptive elastic theory, in which bone adaptation is driven by the strain energy density (SED) per unit mass:

[0161] (1-δ)k≤SED≤(1+ δ)k (1)

[0162] Where: The reference value of k corresponding to the critical SED is 0.004Jg -1 The dead zone where no remodeling occurs is assigned a bandwidth of 10% for δ. When the SED is below or above the dead zone, the tissue density changes through resorption. The density change of the tissue is calculated using equation (2) and the density modulus relationship (such as E = 3790ρ 3 , ρ is tissue density) to update the stiffness matrix. According to the results of literature research, the bone reconstruction rate B is set to 1gcm -3 The average elastic modulus of trabecular bone (12 GPa) was set as the upper limit of bone density for bone formation. max .

[0163] In addition, a conductivity algorithm is used to simulate the effect of implant coating on bone conduction, by modifying the bone remodeling criteria to preferentially allow soft tissue in contact with the coated implant surface to form bone. The tissue strain required for bone formation is lower in the part adjacent to the bone implant surface. When there is no bandwidth (δ = 0), k is 0 Jg -1 , and assuming the reconstruction rate B is 5gcm -3 , to simulate the increased bone regeneration caused by the osteoconductive coating, reducing the threshold SED and bone regeneration rate:

[0164]

[0165] 3) Simulation calculation analysis

[0166] a. Based on the model established by the biomechanical model creation process of the human musculoskeletal system and the bone regeneration mechanism, the finite element method is used to simulate the bone regeneration process.

[0167] b. Compare and analyze the bone regeneration with and without mechanical stimulation to clarify the effect of mechanical stimulation on the bone regeneration process.

[0168] 4) Result evaluation

[0169] a. Evaluation criteria: Based on the simulation results, the effect of mechanical stimulation on bone regeneration was evaluated, including the quantity, quality, and distribution of new bone formation and the bonding strength of the bone-implant interface.

[0170] b. Computational methods: Use quantitative indicators (such as bone volume fraction, bone density, interface shear strength) and qualitative observations (such as trabecular bone structure) to evaluate the simulation results.

[0171] In other embodiments, a biomechanical evaluation system for a bone defect repair implant is provided, comprising:

[0172] 3D modeling module, used to build 3D digital models of the human musculoskeletal system and implants;

[0173] Finite element analysis module, used to simulate mechanical loading on three-dimensional digital models;

[0174] Performance evaluation module, used to evaluate the biomechanical performance of implants under simulated forces;

[0175] The optimization design module is used to adjust the design parameters of the implant according to the evaluation results.

[0176] In some embodiments, the 3D modeling module includes:

[0177] A data acquisition unit, used to collect the actual size of the bone defect, the complete size of the bone where the defect is located, and the size data and material properties of the implant;

[0178] The modeling unit is used to construct a biomechanical model of the human musculoskeletal system and a three-dimensional digital model of a bone defect repair implant based on the collected data.

[0179] In some embodiments, the finite element analysis module includes:

[0180] Boundary condition setting unit, used to set reasonable boundary conditions and loading conditions;

[0181] The mechanical loading simulation unit is used to simulate the stress conditions of implants under static and dynamic loads.

[0182] In some embodiments, the performance evaluation module includes:

[0183] Interface bonding strength evaluation unit, used to analyze the interface bonding strength between the implant and the surrounding bone tissue;

[0184] Stability assessment unit, used to evaluate the stability of implants during long-term use;

[0185] Durability Assessment Unit, used to assess the durability of implants during long-term use.

[0186] In some embodiments, the optimization design module includes:

[0187] a design parameter adjustment unit, used for adjusting the design parameters of the implant according to the evaluation results;

[0188] The optimization result verification unit is used to verify whether the optimized implant meets the preset biomechanical performance standards.

[0189] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein by equivalents. These modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention, and they should all be included in the scope of the claims and specification of the present invention.

Claims

1. A biomechanical evaluation method for bone defect repair implants, characterized in that: include: Construct a three-dimensional digital model that includes a biomechanical model of the human musculoskeletal system and an implant for bone defect repair; Finite element analysis is used to simulate the stress of bone defect repair implants in different gait and motion modes, so as to simulate the stress of implants in actual service. The simulation calculates the stress distribution, deformation and fatigue life of the implant under simulated force, and adjusts the design parameters of the implant until the preset standards are met.

2. The biomechanical evaluation method for bone defect repair implant according to claim 1, characterized in that: The construction of the three-dimensional digital model includes: Collect the actual size of the bone defect, the complete size of the bone where the defect is located, and the size data and material properties of the implant; A three-dimensional model of the interaction between the implant and the surrounding bone tissue was constructed using three-dimensional modeling software based on the collected data and combined with the medical imaging data of the bone defect.

3. The biomechanical evaluation method for bone defect repair implant according to claim 1, characterized in that: The force simulation includes: According to the kinematics and inverse dynamics simulation results of the human musculoskeletal system, the actual stress conditions of the bone defect are determined, and reasonable boundary conditions and loading conditions are set; Simulate implant stresses under static and dynamic loading, including different gait and movement patterns.

4. The biomechanical evaluation method for bone defect repair implant according to claim 1, characterized in that: The biomechanical properties of the implant are evaluated as follows: Analyze the interface bonding strength between the implant and the surrounding bone tissue; Evaluate the stress distribution, deformation, fatigue life, stability and durability of implants during long-term use.

5. A biomechanical evaluation system for bone defect repair implants, characterized in that: include: 3D modeling module, used to build 3D digital models of the human musculoskeletal system and implants; A finite element analysis module, used for performing mechanical loading simulation on the three-dimensional digital model; Performance evaluation module, used to evaluate the biomechanical performance of implants under simulated forces; The optimization design module is used to adjust the design parameters of the implant according to the evaluation results.

6. The bone defect repair implant biomechanical evaluation system according to claim 5, characterized in that: The three-dimensional modeling module includes: A data acquisition unit, used to collect the actual size of the bone defect, the complete size of the bone where the defect is located, and the size data and material properties of the implant; The modeling unit is used to construct a biomechanical model of the human musculoskeletal system and a three-dimensional digital model of a bone defect repair implant based on the collected data.

7. The biomechanical evaluation system for bone defect repair implant according to claim 5, characterized in that: The finite element analysis module includes: Boundary condition setting unit, used to set reasonable boundary conditions and loading conditions; The mechanical loading simulation unit is used to simulate the stress conditions of implants under static and dynamic loads.

8. The bone defect repair implant biomechanical evaluation system according to claim 5, characterized in that: The performance evaluation module includes: Interface bonding strength evaluation unit, used to analyze the interface bonding strength between the implant and the surrounding bone tissue; Stability assessment unit, used to evaluate the stability of implants during long-term use; Durability Assessment Unit, used to assess the durability of implants during long-term use.

9. The bone defect repair implant biomechanical evaluation system according to claim 5, characterized in that: The optimization design module includes: A design parameter adjustment unit, used for adjusting the design parameters of the implant according to the evaluation results; The optimization result verification unit is used to verify whether the optimized implant meets the preset biomechanical performance standards.

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