Intelligent digital modularization implementation method for customized orthopedic insoles

Abstract

The invention relates to the technical field of medical rehabilitation instruments, in particular to an intelligent digital modularization implementation method for customized orthopedic insoles. The three-dimensional shape and pressure distribution information of the foot of a patient are collected, an insole template is prefabricated according to different race foot types and special diseases, correction requirements are determined through anatomical feature point alignment and gait and arch data analysis after data are imported, and a personalized adjustment mode is realized by means of various adjustable modules such as thickness, outer side heightening and forefoot lengthening. Finely customizing the insole by matching with a sole imprinting mode; a display module library is divided according to forefoot, middle foot and rear foot areas, and selected modules are automatically loaded to corresponding areas of the insoles; by means of the digital technology and the modular design, the customization efficiency, precision and adaptability of the orthopedic insole are comprehensively improved, a precise and personalized foot supporting and correcting scheme is provided for patients suffering from foot deformity, sports injuries and various foot discomfort, and development of the foot health care technology is powerfully promoted.

Description

Technical Field

[0001] The present invention relates to the technical field of medical rehabilitation equipment, and in particular to a method for realizing intelligent digital modularization of customized orthopedic insoles. Background Art

[0002] In the field of foot health protection and correction, orthopedic insoles, as key auxiliary devices, have a long history of development. As early as the last century, foreign countries took the lead in exploring orthopedic insole technology. During World War II, in order to enhance the marching ability of soldiers, Germany conducted research on different foot types and developed corresponding foot auxiliary devices, which became an important starting point for the development of orthopedic insole technology. Since then, the technology has continued to evolve and has a history of application of more than 130 years.

[0003] In this long process, the wisdom and practice of many pioneers have laid a solid foundation for it. In 1845, Dr. Drake of Britain innovatively proposed the concept of using deerskin to support the foot, which opened up the thinking about foot support methods; in 1865, Everett of the United States successfully realized the clinical application of arch support theory and transformed the theory into practical treatment methods; in 1948, Dr. George of Romania proposed the Ehrlich effect, which explained the mechanism of action of orthopedic insoles from a theoretical level and provided an important theoretical basis for subsequent technological development; in 1905, Dr. Whitman of Boston launched an early metal arch support orthosis, and in 1910 it continued to be improved to a lighter and more flexible FootEase, which significantly improved the patient's compliance; until 1974, the foot function laboratory founded by Morton led to the emergence of biomechanical customized insoles, further enriching the technical connotation and application scenarios of orthopedic insoles.

[0004] However, with people's increasing attention to foot health and the rapid development of medical technology, the limitations of traditional orthopedic insole design and production processes are becoming increasingly prominent. In the traditional model, patients need to go through multiple complex steps in sequence. During the patient assessment stage, technicians need to rely on their rich experience to manually check the arch shape (such as high arches, flat feet, etc.), foot deformities (such as hallux valgus, hammer toes, etc.) and gait characteristics. The posture assessment process requires careful observation of the patient's standing posture and the force lines of the knee, hip, and spine. The consultation stage requires a comprehensive understanding of the patient's medical history (such as diabetes, foot ulcers, etc.) and daily activity habits, so as to accumulate basic data for subsequent customization work, but the whole process is highly subjective and time-consuming and laborious.

[0005] The modeling process is selected from a variety of methods based on the specific conditions of the patient. Although plaster modeling can obtain a relatively high-precision model, the operation procedure is cumbersome and requires the patient to maintain a specific posture and wrap the foot with a plaster bandage, which is removed after hardening, consuming a lot of time and manpower; the foam box modeling is easy to operate and is suitable for mild needs or situations with high production speed requirements, but the accuracy of the model is limited; the wax printing method focuses on the evaluation of dynamic pressure distribution and has shortcomings in making accurate models. In the measurement and marking stage, due to the inherent characteristics of manual operation, it is easily interfered by human factors, resulting in errors in the measurement data, which in turn affects the accuracy of the subsequent insole design. In the process of making models and insoles, manual polishing and trimming are difficult to ensure that the insole and the foot achieve a high-precision match, and adaptation deviations are prone to occur. The adaptation and adjustment process requires multiple trials and repeated modifications, which is extremely inefficient and seriously affects the patient's experience and treatment process.

[0006] At the same time, in terms of foot data acquisition and analysis, traditional methods have fatal flaws such as low efficiency and large errors. When faced with complex and diverse foot deformities or special diseases, traditional methods often fail to accurately grasp the subtle differences in the patient's feet and cannot provide reliable data support for precise customization, which greatly limits the correction effect and adaptability of orthopedic insoles, and is far from meeting people's urgent needs for personalized, high-precision and high-efficiency orthopedic insoles.

[0007] In summary, an innovative technical approach is urgently needed to break the shackles of traditional craftsmanship and achieve efficient, precise and personalized customization of orthopedic insoles to meet the growing demand for foot health care and improve patients' quality of life. Summary of the invention

[0008] In view of the many defects of the existing orthopedic insole manufacturing technology, such as complicated customization process, poor precision, low efficiency, and poor foot data acquisition and analysis effect, the present invention provides a method for realizing intelligent digital modularization of customized orthopedic insoles. This method deeply integrates digital technology and modular design concepts, and comprehensively addresses various foot health problems such as foot deformities, sports injuries, and foot pain, while taking into account sports performance optimization and foot protection needs of special populations. By collecting foot data with high precision, efficiently carrying out insole design and module combination, and relying on advanced digital processing and manufacturing technology, the efficiency, precision and adaptability of customized orthopedic insoles are greatly improved, effectively meeting the diverse demands of different patients in terms of foot deformity correction, sports injury protection, foot pain relief, and foot protection for special populations, thereby providing solid and efficient technical support and solutions for foot health care.

[0009] To achieve the above object, the technical solution adopted by the present invention is: a method for realizing intelligent digital modularization of customized orthopedic insoles, comprising the following steps:

[0010] S1. Foot data collection step: using a 3D scanner to perform an all-round scan on the patient's foot, collecting three-dimensional morphological data including at least one or more key point information of the arch height, plantar surface, first metatarsal head, fifth metatarsal head and calcaneal center point, and generating a plantar scan file;

[0011] Using a plantar pressure tester, the patient is placed in different weight-bearing situations to obtain dynamic and static plantar pressure distribution information;

[0012] S2, insole size selection and data evaluation and analysis steps: This step is subdivided into digital modeling, data evaluation and data analysis sub-steps, among which,

[0013] In the digital modeling sub-phase, the software pre-builds a variety of insole templates. These shoe size templates are classified and set according to the foot shape characteristics of different ethnic groups or special clinical symptoms to meet the needs of accurate size selection. In this process, the insole template that matches the actual foot length of the insole user and the size of the shoes to be worn is selected from a large number of templates;

[0014] In the data assessment sub-phase, the patient's plantar scan file and plantar pressure distribution data are imported into the software and converted into a digital foot model. The model is used to accurately align the anatomical feature points with the imported shoe size template. In the data analysis sub-phase, the patient's gait abnormality is deeply analyzed in combination with the acquired pressure data, and the arch-related data is analyzed to clarify the correction needs.

[0015] S3, personalized adjustment step: based on the above analysis results, enter the personalized adjustment mode, and carry out all-round personalized customization of the insole with a variety of modules with adjustable functions;

[0016] S4, Plantar Imprint Mode Steps: Turn on the plantar imprint mode to accurately imprint the personalized shape of a specific area of ​​the sole on the insole, and flexibly adjust the imprinted area through convenient operations;

[0017] S5. Personalized module automatic loading steps: After entering this mode, the system displays the corresponding module set according to the regional division logic of forefoot, midfoot and hindfoot; after selecting the corresponding area, the functional modules that meet the specific foot needs are immediately presented. The selected module can be automatically loaded into the corresponding functional area of ​​the insole. At the same time, the loaded module can be moved. After confirmation, click the confirmation button to complete the loading process. If the activation status is canceled, the module will be removed from the insole immediately. The system can automatically filter or combine modules according to the patient's individual data, and dynamically adjust the size and functional characteristics of the module according to the foot data.

[0018] Furthermore, in the foot data collection step S1, the 3D scanner used is a laser scanning or structured light scanning type, which can capture foot details with high precision; the plantar pressure tester can accurately obtain the patient's pressure distribution information under half-weight and full-weight conditions.

[0019] Furthermore, in the insole selection and data evaluation and analysis step S2, the prefabricated templates in the software are all accompanied by unique identification and concise and clear brief descriptions, which facilitate the user's quick screening operation; in the process of anatomical feature point alignment, the system can automatically identify and match the key anatomical points of the arch apex, the first metatarsal head and the fifth metatarsal head; in the stage of analyzing arch-related data, the arch height and angle are calculated.

[0020] Furthermore, in the personalized adjustment step S3, the multiple adjustable modules include any of the following modules or a combination of multiple modules:

[0021] Thickness module: After the user inputs a specific value, the thickness of the corresponding part of the insole can be changed in real time, and the new thickness value is immediately displayed on the operation interface to ensure the visualization of the adjustment effect;

[0022] Outer Heightening Module: By dragging a specific arrow upwards, the height of the outer side of the insole changes dynamically, and the system simultaneously displays the height change value in real time, allowing users to intuitively control the adjustment range;

[0023] Forefoot lengthening module: Drag the arrow upwards, and the length of the forefoot part of the insole will increase immediately. At the same time, the system will display the scanned image in real time to accurately compare it with the original foot shape to ensure the rationality of the adjustment;

[0024] Anti-pronation module: Drag the arrow upwards to increase the thickness of the outer side of the forefoot, and display the thickness value in real time, effectively correcting the problem of foot pronation;

[0025] Anti-supination module: drag the arrow upwards to increase the thickness of the inner side of the forefoot, and display the thickness value in real time to solve the foot supination phenomenon in a targeted manner;

[0026] Forefoot, midfoot, and heel widening module: Drag the block to the right, and the width of the corresponding forefoot, midfoot, or heel will change in real time, and the width value will be displayed immediately to meet the width adaptation requirements of different parts;

[0027] Inner front pad and outer front pad module: Drag the arrow upwards, the thickness of the inner and outer front pads of the insole will change in real time, and the thickness value will be displayed to provide precise support for the front of the foot;

[0028] Heel inner pad and heel outer pad module: drag the arrow upwards, the thickness of the inner and outer sides of the heel of the insole will change in real time, and the thickness value will be displayed to enhance the stability and comfort of the heel area;

[0029] Heel heightening module: drag the arrow upwards, the insole heel height changes in real time and displays the height value to optimize the heel support effect;

[0030] Inner arch heightening module: drag the arrow upwards, the inner arch height changes in real time, and the height value is displayed to adapt to different arch height requirements;

[0031] Medial arch translation module: Drag the arrows to both sides, and the overall position of the medial arch will change accordingly, allowing you to flexibly adjust the arch position to fit the patient's unique foot structure;

[0032] Heel cup heightening module: drag the arrow upwards, the heel cup height changes in real time and displays the height value, enhancing the wrapping and supporting performance of the heel cup;

[0033] Free adjustment module: The control area can be layered vertically and horizontally, and the insole can be finely adjusted by moving the adjustment points by selecting the frame, and the size changes of key parts can be displayed in real time to achieve highly personalized customization.

[0034] Furthermore, in the plantar imprinting mode step S4, after entering this mode, the user can freely select the forefoot, arch or heel area, and imprint the personalized shape of the relevant area on the insole. For the imprinted area, further fine-tuning can be performed by dragging the adjustment points to make the insole fit the plantar area.

[0035] Furthermore, in the personalized module automatic loading step S5,

[0036] The modules corresponding to the forefoot area at least include any one of the following modules or a combination of multiple modules: a split toe pad function module, a forefoot left and right pad module, a half toe pad function module, a proprioceptive outer front pad function module, a proprioceptive outer toe pad function module, a toe pad function module, a toe belly function module, and a hollow function module;

[0037] After selecting any corresponding functional module or multiple functional modules according to design needs, the corresponding module is automatically loaded into the functional area of ​​the insole; it can be moved left, right, up or down by dragging the arrow; if confirmed, this module can be loaded to realize personalized design of the forefoot area.

[0038] Furthermore, in the personalized module automatic loading step S5,

[0039] The modules corresponding to the midfoot area at least include any one of the following functional modules or a combination of multiple functional modules: a small outer half pad functional module, a small transverse arch full pad functional module, a small transverse arch pad functional module, a proprioceptive inner arch pad functional module, a proprioceptive outer transverse arch pad functional module, a proprioceptive transverse arch pad functional module, a transverse arch full pad functional module, a transverse arch pad functional module, a middle arch functional module, a low arch functional module and a high arch functional module;

[0040] After selecting any corresponding functional module or multiple functional modules according to design requirements, the corresponding modules are automatically loaded into the functional area of ​​the insole; they can be moved left, right, up or down by dragging the arrows;

[0041] The position of the module is finally determined by displaying the plantar pressure map and the plantar scanning image. If confirmed, the module can be loaded to achieve personalized design of the midfoot area.

[0042] Furthermore, in the personalized module automatic loading step S5,

[0043] The modules corresponding to the rear foot area at least include any one of the following functional modules or a combination of multiple functional modules: a heel medial pad functional module, a heel medial tip pad middle functional module, a heel medial tip pad low functional module, a heel medial tip pad high functional module, a heel medial oblique pad functional module, a heel lateral pad functional module, a heel medial tip pad functional module, a heel tip pad functional module, a proprioceptive external arch pad functional module, and a proprioceptive heel cup functional module;

[0044] After selecting any corresponding functional module or multiple functional modules according to design needs, the corresponding module is automatically loaded into the functional area of ​​the insole; it can be moved left, right, up or down by dragging the arrow; if confirmed, this module can be loaded to realize personalized design of the rear foot area.

[0045] Furthermore, it also includes digital processing and production links, including:

[0046] Machining programming or slicing processing: convert the designed insole data into processable machining NC files or slicing files;

[0047] Material selection: Choose matching materials from EVA, TPU or silicone according to the functional requirements of different modules;

[0048] 3D Sculpting or Additive Manufacturing: CNC milling or 3D printing technology is used to produce customized orthotics according to the machining path file and the selected material;

[0049] Post-processing: polishing, assembly and performance testing of the finished product

[0050] In the process of medical rehabilitation, orthopedic insoles are extremely critical auxiliary treatment and prevention tools for patients with foot deformities, sports injuries and various foot discomforts. The present invention focuses on the deep integration and application of digital technology and modular design concepts, directly addressing the complexities, poor precision and low efficiency of the traditional orthopedic insole customization process. By relying on innovative digital modular implementation methods, it achieves efficient, accurate and personalized customized production of multiple types of orthopedic insoles, comprehensively improving their application effectiveness and adaptability in the field of medical rehabilitation, and presenting patients with better foot support and correction solutions, opening up a new direction for traditional technological innovation. The present invention adopts the above technical solution, which has at least the following beneficial effects:

[0051] 1. Use cutting-edge 3D foot scanning technology, including laser scanning, structured light scanning and other precise means, in conjunction with plantar pressure testing technology, to accurately capture the dynamic and static pressure distribution of the patient's foot under different load conditions, while fully recording the patient's personal information, medical history and daily activity habits, and building a detailed patient profile. This breaks the limitations of existing technology in the data collection process, comprehensively and accurately grasps the foot shape and force details, and lays a solid foundation for the subsequent personalized and high-precision customization of insoles, fully meeting the diverse needs of different individuals.

[0052] 2. The software system is equipped with a variety of insole templates that are finely classified according to the foot shapes of different ethnic groups and special clinical symptoms. Combined with precise anatomical feature point alignment, it can identify key anatomical points such as the arch apex and metatarsal head position, as well as in-depth data analysis. It can quickly evaluate gait abnormalities and analyze key arch parameters based on pressure distribution data. This completely changes the inefficiency and inaccuracy of the traditional size selection and fitting process, can quickly lock the fitting starting point, accurately determine the correction direction, and greatly improve the initial fitting success rate of the insole and the foot.

[0053] 3. Innovatively introduce a variety of adjustable modules, such as thickness, lateral heightening, forefoot lengthening, etc., with a unique sole imprinting mode, users can fine-tune the insole shape in multiple dimensions according to their actual needs. Whether it is cushioning for special pressure points on the foot or shaping to fit the unique contour of the sole, it can be easily achieved, surpassing the personalized limitations of existing technologies in all aspects, perfectly fitting the physiological structure of the foot, and meeting the correction needs to the greatest extent while ensuring comfort.

[0054] 4. The forefoot, midfoot, and rearfoot module libraries are divided according to the characteristics of the foot area. Each area is equipped with targeted functional modules, such as the split toe pad and hollow module of the forefoot, the transverse arch pad of the midfoot, and the heel outer tip pad of the rear foot. These modules can be automatically loaded into the corresponding area of ​​the insole, and with the help of convenient dragging operations, flexible position adjustment can be achieved. At the same time, relying on the standardized parameter system, the module size and function are intelligently adapted according to the patient's foot data. This complete set of intelligent module loading mechanisms completely innovates the traditional manual or complex and cumbersome operation mode, ensuring that the functional modules and insoles are perfectly adapted to various complex foot conditions. BRIEF DESCRIPTION OF THE DRAWINGS

[0055] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0056] Figure 1 This is a flow chart of the intelligent digital modularization implementation method of customizing orthopedic insoles of the present invention;

[0057] Figure 2 It is a schematic diagram of the interface for loading the insole template of the present invention;

[0058] Figure 3 It is one of the schematic diagrams of the digital model of the foot of the present invention;

[0059] Figure 4 This is the second schematic diagram of the digital model of the foot of the present invention;

[0060] Figure 5 It is a schematic diagram of pressure distribution of the present invention;

[0061] Figure 6 It is a schematic diagram of the key dimensions of the insole of the present invention;

[0062] Figure 7 is a schematic diagram of the cross-section height of the insole of the present invention;

[0063] Figure 8 It is a schematic diagram of various adjustable modules of the present invention;

[0064] Fig. 9 It is a schematic diagram of the present invention using a thickness module to adjust the thickness of the insole;

[0065] Fig.10 It is a schematic diagram of the present invention using an outer heightening module for adjustment;

[0066] Fig.11 It is a schematic diagram of the present invention using a foot lengthening module for adjustment;

[0067] Fig.12 It is a schematic diagram of the present invention using an anti-rotation front mold adjustment;

[0068] Fig.13 is a schematic diagram of the adjustment of the anti-spin module of the present invention;

[0069] Fig.14 It is a schematic diagram of the adjustment of the forefoot, midfoot and heel widening modules adopted in the present invention;

[0070] Fig.15 This is a schematic diagram of the inner front pad adjustment adopted by the present invention;

[0071] Fig.16 This is a schematic diagram of the adjustment of the outer front pad module adopted in the present invention;

[0072] Fig.17 is a schematic diagram of the adjustment of the inner side pad of the heel adopted in the present invention;

[0073] Fig.18 It is a schematic diagram of the adjustment of the outer pad module adopted in the present invention;

[0074] Fig.19 This is a schematic diagram of the adjustment of the heel heightening module used in the present invention;

[0075] Fig. 20 It is a schematic diagram of the present invention using the arch control module for adjustment;

[0076] Fig.21 It is a schematic diagram of the movable position of the adjustment area of ​​the present invention;

[0077] Fig. 22 is a schematic diagram of the translation of the arch of the foot of the present invention;

[0078] Fig.23 This is a schematic diagram of the heightening adjustment of the heel cup of the present invention;

[0079] Fig.24 It is a schematic diagram of the free adjustment module of the present invention;

[0080] Fig.25 It is a schematic diagram of the structure of the plantar imprinting pattern of the present invention;

[0081] Fig.26 is a schematic diagram of the interface of the present invention for entering the plantar imprint mode;

[0082] Fig. 27 It is a schematic diagram of the personalized shape of the present invention being directly printed on the insole;

[0083] Fig.28 It is a schematic diagram of the present invention that the imprint area can be adjusted by dragging the adjustment point;

[0084] Fig.29It is an intuitive icon diagram of each module presented after clicking the forefoot area of ​​the present invention;

[0085] Fig.30 Schematic diagram of the insole of the present invention after adopting the toe-split pad functional module;

[0086] Fig.31 This is a schematic diagram of the present invention using a split toe pad functional module and then loading it into an insole;

[0087] Fig.32 It is an intuitive icon schematic diagram showing each module presented after clicking the midfoot area of ​​the present invention;

[0088] Fig.33 It is a schematic diagram of the present invention after adopting the transverse bow pad functional module;

[0089] Fig.34 It is a schematic diagram of the plantar pressure distribution diagram of the present invention;

[0090] Fig.35 This is a schematic diagram obtained by finally confirming that this module is loaded;

[0091] Fig.36 It is an intuitive icon diagram of each module presented after clicking the "hind foot" area of ​​the present invention;

[0092] Fig.37 It is a schematic diagram of the present invention using the outer tip pad of the heel to drag the arrow to move.

[0093] Fig.38 It is a schematic diagram showing the intuitive icons of each module presented after clicking the body sensing area of ​​the present invention. DETAILED DESCRIPTION

[0094] Exemplary embodiments will be described in detail herein, examples of which are shown in the accompanying drawings. When the following description refers to the drawings, the same numbers in different drawings represent the same or similar elements unless otherwise indicated. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present invention. Instead, they are merely examples of devices and methods consistent with some aspects of the present invention as detailed in the appended claims.

[0095] Traditional craftsmanship and fitting process of orthopedic insoles:

[0096] 1. Patient Assessment

[0097] Foot examination: Check the patient's arch shape (high arches, flat feet), foot deformities (such as hallux valgus, hammer toes), and gait characteristics.

[0098] Postural assessment: Observe the patient's standing posture, knee, hip, and spine alignment.

[0099] Interview: Learn about the patient's medical history (such as diabetes, foot ulcers) and daily activities.

[0100] 2. Modulus taking method

[0101] Choose the appropriate impression method based on the patient's needs and foot condition:

[0102] Plaster cast: The patient sits or lies on his back with his foot in a natural position. A plaster bandage is wrapped around the foot to form a mold, which is removed after the plaster hardens. This method is suitable for patients who need high-precision support, such as those with severe arch collapse or deformity.

[0103] Foam box molding: The patient stands or sits and steps the foot into a special foam box to form the foot contour. Suitable for mild orthopedic needs or quick production needs.

[0104] Wax impression method: When the patient is standing or sitting, the foot is placed on a heated and softened wax plate to form a foot impression. It is often used to evaluate dynamic pressure distribution.

[0105] 3. Measurement and marking

[0106] Label the plantar anatomical features, such as the first metatarsal head, fifth metatarsal head, and calcaneal center.

[0107] Measure arch height, length, and width, as well as other necessary parameters.

[0108] 4. Make the Model

[0109] A positive mold (a physical model of the foot) is made from a plaster mold or foam model to provide a basis for the subsequent production of the insole.

[0110] 5. Insole production

[0111] Overlay materials (such as EVA, foam, silicone, etc.) on the model and polish and trim according to orthopedic needs.

[0112] Ensure that the insole provides adequate arch support and make adjustments based on patient feedback.

[0113] 6. Adaptation and Adjustment

[0114] Fitting: Place the insole into the patient's shoe for a fitting.

[0115] - Fine-tuning: The insole is further modified based on the wearing effect to ensure comfort and orthotic effect.

[0116] This traditional manual molding process relies heavily on the precision of the orthopedic insole and requires experienced technicians to operate. It has at least the following shortcomings:

[0117] 1. Although there are steps such as foot examination, posture assessment and medical consultation, their accuracy is greatly reduced compared with the digital collection method of the present invention. For example, in the acquisition of foot morphology data, it is difficult to fully capture the complex curved surface morphology and subtle structural changes of the foot by manually measuring the arch height, length, width and marking limited plantar anatomical features. Information such as the precise curvature of the first metatarsal head, the fifth metatarsal head and the area around the center of the calcaneus cannot be accurately quantified, and key details are easily missed, resulting in incomplete basic data for subsequent insole design.

[0118] The pressure distribution assessment method is primitive. Although the wax printing method is used for dynamic pressure distribution assessment, compared with the multi-state, high-precision pressure data obtained by the plantar pressure tester of the present invention, it can only provide a very rough pressure imprint and cannot accurately reflect the pressure value changes in different areas of the sole at different load-bearing stages. It is difficult to provide a strong basis for the precise insole pressure adjustment design.

[0119] 2. Although plaster molding is theoretically suitable for high-precision requirements, the operation is extremely cumbersome. From patient positioning, bandage wrapping to hardening and removal, the process is lengthy and easily affected by factors such as the technician's operating proficiency and the fit of the bandage. Any carelessness will cause the mold to deform, which will reduce the accuracy.

[0120] Although the foam box molding and wax printing methods are relatively quick, they compromise too much on accuracy. The foam box can only obtain a rough outline, and the dynamic evaluation accuracy of the wax printing method is insufficient. It is impossible to take into account both efficiency and accuracy, and it is difficult to meet diverse orthopedic needs.

[0121] 3. In the model making process, technicians rely on manual work to make positive molds using plaster molds or foam models. The technicians' personal experience and techniques have a huge impact on the quality of the model. Models made by different technicians may be different, making it difficult to ensure the consistency of subsequent insoles.

[0122] The production of insoles is based on manual superposition of materials and polishing and finishing, and the design of arch support relies more on the subjective judgment of technicians. It lacks a scientific basis based on algorithm analysis and digital module combination like the present invention. The adjustment process is trial and error, which is time-consuming and laborious. In addition, it is difficult to achieve the ideal comfort and orthopedic effect, and the adaptation process is inefficient.

[0123] 4. Although traditional processes have a consultation process to understand the patient's medical history and daily activity habits, in actual design and production, they lack the ability to deeply integrate this information into the personalized module design and adjustment of the insole like the present invention, such as automatic loading and adaptation of specific modules for special groups such as diabetic patients and sports enthusiasts, making it difficult to fully meet the personalized needs of patients.

[0124] 5. The entire process, from mold taking to final adaptation and adjustment, has numerous and scattered links, and manual operations are performed throughout. There is no standardized, digital closed-loop process from data collection, design to production like the present invention, which makes it difficult to achieve large-scale, efficient customized production, and is not conducive to technology promotion and quality control.

[0125] To this end, the present invention adopts a digital modular implementation method based on digital modeling and functional module combination technology. By scanning and collecting patient foot data, a digital model is established, and then through the combination design of standardized modules, high-precision, multi-type customized production of orthopedic insoles is achieved.

[0126] Embodiment 1:

[0127] like Figure 1 As shown, this embodiment provides a method for implementing intelligent digital modularization of customized orthopedic insoles, comprising the following steps:

[0128] S1. Foot data collection step: using a 3D scanner to perform an all-round scan on the patient's foot, collecting three-dimensional morphological data including at least one or more key point information of the arch height, plantar surface, first metatarsal head, fifth metatarsal head and calcaneal center point, and generating a plantar scan file;

[0129] Using a plantar pressure tester, the patient is placed in different weight-bearing situations to obtain dynamic and static plantar pressure distribution information;

[0130] S2, insole size selection and data evaluation and analysis steps: This step is subdivided into digital modeling, data evaluation and data analysis sub-steps, among which,

[0131] In the digital modeling sub-phase, the software pre-builds a variety of insole templates. These shoe size templates are classified and set according to the foot shape characteristics of different ethnic groups or special clinical symptoms to meet the needs of accurate size selection. In this process, the insole template that matches the actual foot length of the insole user and the size of the shoes to be worn is selected from a large number of templates;

[0132] In the data assessment sub-phase, the patient's plantar scan file and plantar pressure distribution data are imported into the software and converted into a digital foot model. The model is used to accurately align the anatomical feature points with the imported shoe size template. In the data analysis sub-phase, the patient's gait abnormality is deeply analyzed in combination with the acquired pressure data, and the arch-related data is analyzed to clarify the correction needs.

[0133] S3, personalized adjustment step: based on the above analysis results, enter the personalized adjustment mode, and carry out all-round personalized customization of the insole with a variety of modules with adjustable functions;

[0134] S4, Plantar Imprint Mode Steps: Turn on the plantar imprint mode to accurately imprint the personalized shape of a specific area of ​​the sole on the insole, and flexibly adjust the imprinted area through convenient operations;

[0135] S5. Personalized module automatic loading steps: After entering this mode, the system displays the corresponding module set according to the regional division logic of forefoot, midfoot and hindfoot; after selecting the corresponding area, the functional modules that meet the specific foot needs are immediately presented. The selected module can be automatically loaded into the corresponding functional area of ​​the insole. At the same time, the loaded module can be moved. After confirmation, click the confirmation button to complete the loading process. If the activation status is canceled, the module will be removed from the insole immediately. The system can automatically filter or combine modules according to the patient's individual data, and dynamically adjust the size and functional characteristics of the module according to the foot data.

[0136] As a preferred implementation, in the foot data collection step S1 in this embodiment, the 3D scanner used is a laser scanning or structured light scanning type, which can capture foot details with high precision; the plantar pressure tester can accurately obtain the patient's pressure distribution information under half-weight and full-weight conditions.

[0137] As a preferred implementation, in the insole size selection and data evaluation and analysis step S2 of this embodiment, the prefabricated templates in the software are all accompanied by unique identification and concise and clear brief descriptions to facilitate users' quick screening operations; in the process of anatomical feature point alignment, the system can automatically identify and match the key anatomical points of the arch apex, the first metatarsal head and the fifth metatarsal head; in the stage of analyzing arch-related data, the arch height and angle are calculated.

[0138] like Figure 8 As shown, as a preferred implementation, in the personalized adjustment step S3 in this embodiment, the multiple adjustable modules include any of the following modules or a combination of multiple modules:

[0139] Thickness module: After the user inputs a specific value, the thickness of the corresponding part of the insole can be changed in real time, and the new thickness value is immediately displayed on the operation interface to ensure the visualization of the adjustment effect;

[0140] Outer Heightening Module: By dragging a specific arrow upwards, the height of the outer side of the insole changes dynamically, and the system simultaneously displays the height change value in real time, allowing users to intuitively control the adjustment range;

[0141] Forefoot lengthening module: Drag the arrow upwards, and the length of the forefoot part of the insole will increase immediately. At the same time, the system will display the scanned image in real time to accurately compare it with the original foot shape to ensure the rationality of the adjustment;

[0142] Anti-pronation module: Drag the arrow upwards to increase the thickness of the outer side of the forefoot, and display the thickness value in real time, effectively correcting the problem of foot pronation;

[0143] Anti-supination module: drag the arrow upwards to increase the thickness of the inner side of the forefoot, and display the thickness value in real time to solve the foot supination phenomenon in a targeted manner;

[0144] Forefoot, midfoot, and heel widening module: Drag the block to the right, and the width of the corresponding forefoot, midfoot, or heel will change in real time, and the width value will be displayed immediately to meet the width adaptation requirements of different parts;

[0145] Inner front pad and outer front pad module: Drag the arrow upwards, the thickness of the inner and outer front pads of the insole will change in real time, and the thickness value will be displayed to provide precise support for the front of the foot;

[0146] Heel inner pad and heel outer pad module: drag the arrow upwards, the thickness of the inner and outer sides of the heel of the insole will change in real time, and the thickness value will be displayed to enhance the stability and comfort of the heel area;

[0147] Heel heightening module: drag the arrow upwards, the insole heel height changes in real time and displays the height value to optimize the heel support effect;

[0148] Inner arch heightening module: drag the arrow upwards, the inner arch height changes in real time, and the height value is displayed to adapt to different arch height requirements;

[0149] Medial arch translation module: Drag the arrows to both sides, and the overall position of the medial arch will change accordingly, allowing you to flexibly adjust the arch position to fit the patient's unique foot structure;

[0150] Heel cup heightening module: drag the arrow upwards, the heel cup height changes in real time and displays the height value, enhancing the wrapping and supporting performance of the heel cup;

[0151] Free adjustment module: The control area can be layered vertically and horizontally, and the insole can be finely adjusted by moving the adjustment points by selecting the frame, and the size changes of key parts can be displayed in real time to achieve highly personalized customization.

[0152] As a preferred implementation, in the plantar imprint mode step S4 of this embodiment, after entering this mode, the user can freely select the forefoot, arch or heel area, and imprint the personalized shape of the relevant area on the insole. For the imprinted area, further fine-tuning can be performed by dragging the adjustment points to make the insole fit the plantar area.

[0153] As a preferred implementation, in the personalized module automatic loading step S5 in this embodiment,

[0154] The modules corresponding to the forefoot area at least include any one of the following modules or a combination of multiple modules: a split toe pad function module, a forefoot left and right pad module, a half toe pad function module, a proprioceptive outer front pad function module, a proprioceptive outer toe pad function module, a toe pad function module, a toe belly function module, and a hollow function module;

[0155] After selecting any corresponding functional module or multiple functional modules according to design needs, the corresponding module is automatically loaded into the functional area of ​​the insole; it can be moved left, right, up or down by dragging the arrow; if confirmed, this module can be loaded to realize personalized design of the forefoot area.

[0156] As a preferred implementation, in the personalized module automatic loading step S5 in this embodiment,

[0157] The modules corresponding to the midfoot area at least include any one of the following functional modules or a combination of multiple functional modules: a small outer half pad functional module, a small transverse arch full pad functional module, a small transverse arch pad functional module, a proprioceptive inner arch pad functional module, a proprioceptive outer transverse arch pad functional module, a proprioceptive transverse arch pad functional module, a transverse arch full pad functional module, a transverse arch pad functional module, a middle arch functional module, a low arch functional module and a high arch functional module;

[0158] After selecting any corresponding functional module or multiple functional modules according to design requirements, the corresponding modules are automatically loaded into the functional area of ​​the insole; they can be moved left, right, up or down by dragging the arrows;

[0159] The position of the module is finally determined by displaying the plantar pressure map and the plantar scanning image. If confirmed, the module can be loaded to achieve personalized design of the midfoot area.

[0160] As a preferred implementation, in the personalized module automatic loading step S5 in this embodiment,

[0161] The modules corresponding to the rear foot area at least include any one of the following functional modules or a combination of multiple functional modules: a heel medial pad functional module, a heel medial tip pad middle functional module, a heel medial tip pad low functional module, a heel medial tip pad high functional module, a heel medial oblique pad functional module, a heel lateral pad functional module, a heel medial tip pad functional module, a heel tip pad functional module, a proprioceptive external arch pad functional module, and a proprioceptive heel cup functional module;

[0162] After selecting any corresponding functional module or multiple functional modules according to design needs, the corresponding module is automatically loaded into the functional area of ​​the insole; it can be moved left, right, up or down by dragging the arrow; if confirmed, this module can be loaded to realize personalized design of the rear foot area.

[0163] As a preferred implementation, this embodiment also includes digital processing and production steps: specifically including:

[0164] Machining programming or slicing processing: convert the designed insole data into processable machining NC files or slicing files;

[0165] Material selection: Choose matching materials from EVA, TPU or silicone according to the functional requirements of different modules;

[0166] 3D Sculpting or Additive Manufacturing: CNC milling or 3D printing technology is used to produce customized orthotics according to the machining path file and the selected material;

[0167] Post-processing: polishing, assembly and performance testing of the finished product

[0168] Embodiment 2

[0169] 1. Overview of the overall process

[0170] This implementation provides a specific example of a method for implementing intelligent digital modularization of customized orthopedic insoles to solve many problems in the traditional orthopedic insole customization process and achieve efficient, accurate and personalized insole customization. The entire process includes key links such as foot data collection, insole size selection and data evaluation and analysis, personalized adjustment, plantar imprint pattern, personalized "module" automatic loading, and digital processing and production. All links work closely together to serve the final output of customized orthopedic insoles.

[0171] 2. Foot Data Collection

[0172] 1. 3D foot scanning: Use an advanced 3D foot scanner, such as a laser scanning or structured light scanning device, and place the patient's foot in the designated scanning area to ensure that the foot is in a natural and relaxed state. During the scanning process, the device emits a laser beam or structured light, and the light covers all surfaces of the foot, capturing the three-dimensional morphological information of the foot from multiple angles. The reflected light signal is received by a high-precision optical sensor, and the built-in algorithm is used to convert these signals into three-dimensional morphological data containing arch height, plantar surface, and key point information such as the first metatarsal head, fifth metatarsal head, and calcaneal center point, generating a detailed plantar scan file.

[0173] 2. Plantar pressure test: Let the patient stand on a professional plantar pressure tester. The sensing panel of the tester is composed of a high-sensitivity pressure sensor array, which can accurately sense the changes in plantar pressure. First, guide the patient to a semi-weight-bearing state, that is, the center of gravity of the body falls on the test foot, keep it stable for a few seconds, and record the dynamic and static pressure distribution information of the plantar at this time; then let the patient switch to a full-weight-bearing state and repeat the pressure data collection operation.

[0174] 3. Patient file establishment: While conducting the above two tests, record the patient's personal information, including age, gender, occupation and other basic information, with a focus on medical history information, such as whether they suffer from diabetes, foot ulcers, arthritis and other diseases, as well as daily activity habits, including whether they exercise regularly, the type of exercise (running, basketball, etc.), the length of time they stand at work, the condition of the walking surface and other details. Enter this information one by one into a specially designed patient file management system to lay the foundation for comprehensive consideration of subsequent insole customization.

[0175] 3. Insole selection and data evaluation and analysis

[0176] 1. Digital modeling and template selection: Start the insole customization software, which has a rich and diverse library of shoe size insole templates. These templates are carefully constructed based on a large amount of big data on foot shapes of different ethnic groups and common special clinical conditions (such as flat feet, high arches, hallux valgus, diabetic foot, etc.). Each template comes with a unique identification code, a clear text description, and a brief adaptation instruction to facilitate users to quickly screen. Based on the foot length information in the patient's file and the size of the shoe he or she has selected, a group of insole templates with a high degree of adaptation are initially screened out. Load it into the software's design interface (such as Figure 2 ), ready to interface with the patient's foot data.

[0177] 2. Alignment of evaluation data with anatomical feature points: Import the previously collected patient plantar scan files and plantar pressure distribution data into the insole customization software. The software automatically starts the data conversion program to convert the scan files into a high-precision digital model of the foot (such as Figure 3 and Figure 4 ). Using advanced image recognition and matching algorithms, the model and the loaded insole template perform anatomical feature point alignment operations, accurately identifying and automatically matching key anatomical points such as the arch apex, the first metatarsal head, and the fifth metatarsal head, ensuring that the initial fit between the template and the patient's foot is accurate and correct.

[0178] 3. Data analysis and correction needs determination: Combined with the imported pressure data, the built-in gait analysis module of the software starts to work. By analyzing the pressure distribution data (as shown in 5), it is estimated whether the patient has gait abnormalities such as excessive pronation, supination, and uneven arch force.

[0179] like Figure 6 and Figure 7 As shown, the arch height and angle are calculated, and the calculated results are compared with the built-in normal arch data range to accurately determine the patient's specific correction needs and provide clear direction for subsequent personalized adjustments.

[0180] 4. Personalized Adjustment

[0181] like Figure 8 , is a schematic diagram of various adjustable modules.

[0182] The left column includes thickness module, forefoot lengthening module, forefoot widening module, midfoot widening module, heel widening module, heel heightening module, inner arch heightening module, inner arch translation module, and free adjustment module;

[0183] The right column includes a lateral heightening module, an anti-pronation module, an anti-supination module, an inner front pad module, an outer front pad module, an inner heel pad module, an outer heel pad module, and a heel cup heightening module.

[0184] like Fig. 9 As shown in the figure, the personalized adjustment interface of the software is found in the thickness module function area. According to the requirements of the insole thickness, the user enters the precise thickness value in millimeters in the corresponding value input box. After clicking the "Thicken" button, the new thickness value will be displayed at any time.

[0185] like Fig.10 As shown in the figure, the personalized adjustment interface of the software is located at the outer heightening module. A blue arrow icon is displayed on the interface, and the arrow is pointing vertically upward, indicating the direction of heightening. The user clicks and holds the blue arrow with the mouse, and drags it upward, and the outer edge of the insole model rises dynamically.

[0186] like Fig.11 As shown in the figure, when the forefoot length needs to be adjusted, the forefoot lengthening module is enabled. The user clicks the upward green arrow, and the length of the forefoot part of the insole begins to gradually increase, changing the forefoot length of the insole, and the scanned graph can be displayed for comparison; the length value during the adjustment process is updated in real time.

[0187] like Fig.12 As shown in the figure, for patients with foot pronation or supination problems, the anti-pronation and anti-supination modules are used respectively. In the anti-pronation module, the user drags the blue arrow upwards, and the software increases the thickness of the outer forefoot of the insole in real time and displays the thickness change value instantly to correct excessive pronation of the foot;

[0188] like Fig.13 As shown, similarly, in the anti-supination module, drag the blue arrow upwards to increase the medial thickness of the forefoot, and the adjusted value will be displayed in real time to effectively combat foot supination deformation.

[0189] like Fig.14 As shown, if you want to adjust the insole width, in the corresponding forefoot, midfoot, and heel widening module areas, the user will see a red square icon pointing to the right. Click and hold the red square and drag it to the right. The software will change the width of the corresponding part of the insole in real time, and the width value will be updated in real time on the interface.

[0190] like Fig.15 and Fig.16As shown, in the inner front pad / outer front pad module, drag the blue arrow upwards to change the thickness of the inner and outer front pads of the insole, and the thickness value is displayed in real time.

[0191] like Fig.17 and Fig.18 As shown, in the heel inner / outer pad module, drag the blue arrow upwards to change the thickness of the inner and outer sides of the heel of the insole. The thickness value is real-time.

[0192] like Fig.19 As shown, the heel heightening module, drag the blue arrow upwards to process the heel of the insole, and the value is displayed in real time.

[0193] like Fig. 20 As shown in the figure, the arch control module. The arch is the key area in the insole design, corresponding to a variety of patient groups such as flat feet, high arches, and a large number of sports people. Drag the blue arrow upward to change the arch height, and the regional multi-value is displayed in real time.

[0194] like Fig.21 As shown, the position of the adjustment area can be moved;

[0195] like Fig. 22 As shown in the figure, the arch of the foot moves horizontally. Drag the green arrows to both sides to change the overall position of the arch of the foot.

[0196] like Fig.23 As shown, the heel cup is raised. Drag the blue arrow upward to change the heel cup height, and the value is displayed in real time.

[0197] like Fig.24 As shown, free adjustment module: after the sole scan is displayed and the insole is aligned, the control area can be layered vertically and horizontally, and each layer consists of "adjustment points". The sole scan image can be opened at any time for contour design comparison. The size of key parts is displayed in real time.

[0198] Select the "Adjustment Point" corresponding to the area to be adjusted, and the color will change from black to yellow. As shown in the following figure, select the lower right area of ​​the heel and drag the red arrow to change the width of the heel area to make the insole fit the size of the sole scan.

[0199] like Fig.25 As shown in the figure, enter the sole imprint mode, and the software interface lists the selectable areas such as "forefoot", "arch", and "heel". Users select the area they want to imprint according to the characteristics of their own soles. After clicking the corresponding button, the software will directly "imprint" the personalized shape of the area on the insole, presenting a preliminary shape that fits the sole. After that, users can also make further fine adjustments to the imprint area by dragging the "adjustment point". The software will update the shape of the insole in real time and show the comparison effect before and after the adjustment to ensure that the insole fits perfectly with the specific area of ​​the sole.

[0200] like Fig.26As shown, the scanned image of the sole of the foot is opened, that is, the real shape of the sole of the actual wearer;

[0201] like Fig. 27 As shown, by selecting "Forefoot / Arch / Heel", the personalized shape of the relevant area can be "printed" directly on the insole

[0202] like Fig.28 As shown, the "Blot" area can be adjusted by dragging the "Adjustment Points";

[0203] 5. Personalized "module" automatic loading

[0204] Module library display and region selection

[0205] 1. Turn on the personalized "module" automatic loading mode. The software clearly displays the corresponding module library classification list in the interface according to the regional division logic of forefoot, midfoot, rearfoot and proprioception. The module icons under each area are presented in an intuitive and easy-to-understand form, such as the split toe pad icon in the forefoot area that resembles a separated toe, and the hollow module icon is displayed as a square with a hollow pattern, etc., which is convenient for users to quickly identify functions.

[0206] Forefoot module operation

[0207] After selecting the "Forefoot" area, the software displays the modules available in this area above the insole design area on the right, such as Fig.29 As shown, the intuitive icons of each module presented after clicking the "forefoot" area are displayed. It can be seen that it specifically includes split toe pads, forefoot left and right pads, half toe pads, toe pads, toe belly and hollowing;

[0208] For example, there are multiple modules such as split toe pads (specially used for hallux valgus patients to relieve toe squeezing pain), hollowing (for diabetic foot patients to avoid local pressure and promote blood circulation), etc. After the user clicks on a functional module, the software starts the automatic loading program, loads the selected module into the forefoot functional area of ​​the insole at the preset optimal initial position, and displays a prompt on the interface indicating that the module has been successfully loaded.

[0209] like Fig.30 and Fig.31As shown in the figure, the operation of local functional modules is taken as an example. Select "forefoot" and all modules corresponding to this area will be displayed; each module corresponds to the insole design with different needs, such as "split toe pad" for "hallux valgus" patients, "hollow" for "diabetic foot patients", etc. After selecting a functional module, such as the split toe pad of the forefoot, the module is automatically loaded into the functional area of ​​the insole. For the loaded modules, if the user feels that the position is not ideal, you can drag the red arrow to move the module left and right, and drag the green arrow to move the module up and down to ensure that the module is accurately adapted to the foot force point and deformity correction needs on the insole. During the adjustment process, the software updates the module position coordinates in real time to facilitate users to accurately locate. When the user confirms that the module position is appropriate, click the green "check" box, the software will fix the module at the current position and complete the loading process; if the user wants to replace or cancel the module, click the cancel "activate" button, the module will be immediately deleted from the insole, and the interface will be restored to the state before the module was loaded.

[0210] Midfoot module operation

[0211] Select the "Midfoot" area, and the operation process is similar to the forefoot module. All modules corresponding to this area will be displayed; Fig.32 As shown in the figure, the intuitive icons of each module are displayed after clicking the "Midfoot" area. Each module corresponds to the insole design of different needs; it can be seen that the specific icons include front arch, middle rear arch, low rear arch, high rear arch, outer half pad, large transverse arch pad, wide low arch, wide high arch, small outer half pad, small transverse arch full pad, small transverse arch pad, transverse arch full pad, transverse arch pad, middle arch, low arch and high arch.

[0212] The software displays modules for midfoot problems such as "transverse arch pad". After the user selects the transverse arch pad module, it is automatically loaded into the midfoot part of the insole. By dragging the red arrow to move left and right and the green arrow to move up and down, combined with the plantar pressure map and plantar scan graph displayed in real time by the software, the user can finally determine the best position of the module to accurately support the midfoot transverse arch and improve problems such as arch collapse. After confirming that everything is correct, click the "check" box to complete the loading. The module position adjustment and confirmation mechanism during the operation is consistent with the forefoot module.

[0213] like Fig.33 and Fig.34 As shown in the figure, the operation of local functional modules is an example. After selecting a functional module, such as the transverse arch pad of the midfoot, the module is automatically loaded into the functional area of ​​the insole. Fig.33 As shown in the figure, drag the red arrow to move the module left or right, and drag the green arrow to move the module up or down. Fig.34 As shown, the "plantar pressure map" and "plantar scanning map" can be displayed to finally determine the location of the module.

[0214] like Fig.35The figure shown is the schematic diagram obtained by finally confirming the loading of this module.

[0215] Hindfoot module operation

[0216] Select the "Hindus" area. Select "Hindus" and all modules corresponding to this area will be displayed. Fig.36 As shown, the intuitive icons of each module are displayed after clicking the "rearfoot" area. Each module corresponds to the insole design of different needs; it can be seen that the specific icons include heel inner pad, heel inner toe pad, heel inner toe pad low, heel inner toe pad high, heel inner oblique pad, heel outer pad, heel outer toe pad, heel outer oblique pad and heel tip pad.

[0217] The software presents modules such as "heel tip pad". After these modules are loaded, in addition to being able to adjust the position by dragging the red arrow left and right and the green arrow up and down, some modules are also equipped with white circle icons. Users can click and hold the white circle with the mouse to drag the module to rotate around the center point to adapt to different foot shapes and needs, especially for uneven force on the outside of the heel or heel eversion. Users determine the module position based on plantar pressure feedback and their own comfort, and click the "check" box to complete the loading. Cancel "activate" to delete the module.

[0218] Take the operation of local functional modules as an example. After selecting a functional module, such as the "heel toe pad" of the rear foot, the module is automatically loaded into the functional area of ​​the insole.

[0219] like Fig.37 As shown in the figure, drag the red arrow to move the module left or right, and the green arrow to move the module up or down. Drag the white circle to rotate the module.

[0220] Proprioception operation, select the "Proprioception" area, select "Proprioception", and all modules corresponding to this area will be displayed; Fig.38 As shown in the figure, the intuitive icons of each module are displayed after clicking the "proprioception" area. Each module corresponds to the insole design of different needs; it can be seen that the specific icons include proprioception-inner arch pad, proprioception-outer front pad, proprioception-outer transverse arch pad, proprioception-outer arch pad, proprioception-outer toe pad, proprioception-transverse arch pad, proprioception-heel cup and proprioception-heel cup 1.

[0221] All functional modules are designed as standardized modules, and standardized parameter libraries for module size and shape are developed. Modules are automatically selected or combined based on patient data. Module size and function are dynamically adjusted based on foot data using parametric modeling technology.

[0222] 6. Digital Processing and Production

[0223] Machining programming or slicing: When the insole design is finalized in the software, start the machining programming software or slicing program. The software converts the 3D model data of the insole into a file that can be recognized by the engraving machine or 3D printing equipment, usually in G-code format. During the process, the software performs layered engraving or printing processing on the insole model according to the preset engraving or printing accuracy, material properties and other parameters, discretizing the continuous 3D model into a series of slice data. Each layer of the slice contains the contour information, path, parameters and other detailed instructions of the layer, providing an accurate processing blueprint for subsequent engraving or 3D printing.

[0224] Material selection: According to the functional requirements of different modules and the individual conditions of patients, choose appropriate materials from a variety of high-quality materials such as EVA, TPU, silicone, etc. For example, for forefoot modules that require higher elasticity and cushioning performance, TPU materials are preferred; for parts that require strong support such as the heel cup, choose EVA materials with higher hardness; for parts that require skin contact and focus on softness and comfort, such as some cushioning pad modules on the inside of the sole, choose silicone materials. The software has a built-in material property database, which lists in detail the key parameters of each material such as elastic modulus, hardness, wear resistance, biocompatibility, and other key parameters, as well as adaptation suggestions with different module functions, so that users can make scientific and reasonable material choices.

[0225] 3D engraving or additive manufacturing: Import the generated tool path file or slice file into a professional CNC milling machine or 3D printing equipment. The equipment accurately controls the movement trajectory of the tool head or print nozzle and the amount of material extrusion according to the instructions in the file. According to the preset engraving tool path or filling path, the selected material is cut or added layer by layer to gradually build the physical shape of the customized orthopedic insole. During the process, the built-in control system of the equipment ensures that the material is in a suitable state to ensure accuracy and quality. At the same time, through real-time monitoring of progress, material margin and other parameters, the whole process is ensured to proceed smoothly and orthopedic insoles that meet the design requirements are efficiently produced.

[0226] Post-processing: Post-process the finished insoles that have been carved or 3D printed. First, use a grinding tool to grind the surface of the insole to remove defects such as layer patterns and burrs generated during the production process, so that the surface of the insole is smooth and flat, and the wearing comfort is improved. If the insole design contains multiple components, such as some complex functional modules that are assembled after printing separately, perform fine combination assembly operations according to the design requirements to ensure that the components are firmly connected and seamlessly connected. Finally, place the insole in a professional performance testing equipment to test its key performance such as support, cushioning, and adaptability. According to the test results, make necessary fine-tuning and optimization of the insole to ensure that the final product quality meets the standards and can provide patients with high-quality foot correction services.

[0227] The above description is only a preferred embodiment of the present invention and is not intended to limit the invention. Although the present invention is described in detail with reference to the aforementioned embodiments, those skilled in the art can still modify the technical solutions described in the aforementioned embodiments or replace some of the technical features therein by equivalents. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A method for realizing intelligent digital modularization of customized orthopedic insoles, characterized in that: The following steps are involved: S1. Foot data collection step: using a 3D scanner to perform an all-round scan on the patient's foot, collecting three-dimensional morphological data including at least one or more key point information of the arch height, plantar surface, first metatarsal head, fifth metatarsal head and calcaneal center point, and generating a plantar scan file; Using a plantar pressure tester, the patient is placed in different weight-bearing situations to obtain dynamic and static plantar pressure distribution information; S2, insole size selection and data evaluation and analysis steps: This step is subdivided into digital modeling, data evaluation and data analysis sub-steps, among which, In the digital modeling sub-phase, the software pre-builds a variety of insole templates. These shoe size templates are classified and set according to the foot shape characteristics of different ethnic groups or special clinical symptoms to meet the needs of accurate size selection. In this process, the insole template that matches the actual foot length of the insole user and the size of the shoes to be worn is selected from a large number of templates; In the data assessment sub-phase, the patient's plantar scan file and plantar pressure distribution data are imported into the software and converted into a digital foot model. The model is used to accurately align the anatomical feature points with the imported shoe size template. In the data analysis sub-phase, the patient's gait abnormality is deeply analyzed in combination with the acquired pressure data, and the arch-related data is analyzed to clarify the correction needs. S3, personalized adjustment step: based on the above analysis results, enter the personalized adjustment mode, and carry out all-round personalized customization of the insole with a variety of modules with adjustable functions; S4, Plantar Imprint Mode Steps: Turn on the plantar imprint mode to accurately imprint the personalized shape of a specific area of ​​the sole on the insole, and flexibly adjust the imprinted area through convenient operations; S5. Personalized module automatic loading steps: After entering this mode, the system displays the corresponding module set according to the regional division logic of forefoot, midfoot and hindfoot; after selecting the corresponding area, the functional modules that meet the specific foot needs are immediately presented. The selected module can be automatically loaded into the corresponding functional area of ​​the insole. At the same time, the loaded module can be moved. After confirmation, click the confirmation button to complete the loading process. If the activation status is canceled, the module will be removed from the insole immediately. The system can automatically filter or combine modules according to the patient's individual data, and dynamically adjust the size and functional characteristics of the module according to the foot data.

2. The method for realizing intelligent digital modularization of customized orthopedic insoles according to claim 1, characterized in that: In the foot data collection step S1, the 3D scanner used is a laser scanning or structured light scanning type, which can capture foot details with high precision; the plantar pressure tester can accurately obtain the patient's pressure distribution information under half-weight and full-weight conditions.

3. The method for realizing intelligent digital modularization of customized orthopedic insoles according to claim 1, characterized in that: In the insole selection and data evaluation and analysis step S2, the prefabricated templates in the software are all accompanied by unique identification and concise and clear brief descriptions, which facilitate the user's quick screening operation; in the process of anatomical feature point alignment, the system can automatically identify and match the key anatomical points of the arch apex, the first metatarsal head and the fifth metatarsal head; in the stage of analyzing arch-related data, the arch height and angle are calculated.

4. The method for realizing intelligent digital modularization of customized orthopedic insoles according to claim 1, characterized in that: In the personalized adjustment step S3, the multiple adjustable modules include any of the following modules or a combination of multiple modules: Thickness module: After the user inputs a specific value, the thickness of the corresponding part of the insole can be changed in real time, and the new thickness value is immediately displayed on the operation interface to ensure the visualization of the adjustment effect; Outer Heightening Module: By dragging a specific arrow upwards, the height of the outer side of the insole changes dynamically, and the system simultaneously displays the height change value in real time, allowing users to intuitively control the adjustment range; Forefoot lengthening module: Drag the arrow upwards, and the length of the forefoot part of the insole will increase immediately. At the same time, the system will display the scanned image in real time to accurately compare it with the original foot shape to ensure the rationality of the adjustment; Anti-pronation module: Drag the arrow upwards to increase the thickness of the outer side of the forefoot, and display the thickness value in real time, effectively correcting the problem of foot pronation; Anti-supination module: Drag the arrow upwards to increase the thickness of the inner side of the forefoot, and display the thickness value in real time to solve the foot supination phenomenon in a targeted manner; Forefoot, midfoot, and heel widening module: Drag the block to the right, and the width of the corresponding forefoot, midfoot, or heel will change in real time, and the width value will be displayed immediately to meet the width adaptation requirements of different parts; Inner front pad and outer front pad module: Drag the arrow upwards, the thickness of the inner and outer front pads of the insole will change in real time, and the thickness value will be displayed to provide precise support for the front of the foot; Heel inner pad and heel outer pad module: drag the arrow upwards, the thickness of the inner and outer sides of the heel of the insole will change in real time, and the thickness value will be displayed to enhance the stability and comfort of the heel area; Heel heightening module: drag the arrow upwards, the insole heel height changes in real time and displays the height value to optimize the heel support effect; Inner arch heightening module: drag the arrow upwards, the inner arch height changes in real time, and the height value is displayed to adapt to different arch height requirements; Medial arch translation module: Drag the arrows to both sides, and the overall position of the medial arch will change accordingly, allowing you to flexibly adjust the arch position to fit the patient's unique foot structure; Heel cup heightening module: drag the arrow upwards, the heel cup height changes in real time and displays the height value, enhancing the wrapping and supporting performance of the heel cup; Free adjustment module: The control area can be layered vertically and horizontally, and the insole can be finely adjusted by moving the adjustment points by selecting the frame, and the size changes of key parts can be displayed in real time to achieve highly personalized customization.

5. The method for realizing intelligent digital modularization of customized orthopedic insoles according to claim 1, characterized in that: In the plantar imprinting mode step S4, after entering this mode, the user can freely select the forefoot, arch or heel area, and imprint the personalized shape of the relevant area on the insole. For the imprinting area, further fine-tuning can be performed by dragging the adjustment points to make the insole fit the plantar area.

6. The intelligent digital modularization method for implementing customized orthopedic insoles according to any one of claims 1 to 5, characterized in that: In the personalized module automatic loading step S5, The modules corresponding to the forefoot area at least include any one of the following modules or a combination of multiple modules: a split toe pad function module, a forefoot left and right pad module, a half toe pad function module, a proprioceptive outer front pad function module, a proprioceptive outer toe pad function module, a toe pad function module, a toe belly function module, and a hollow function module; After selecting any corresponding functional module or multiple functional modules according to design needs, the corresponding module is automatically loaded into the functional area of ​​the insole; it can be moved left, right, up or down by dragging the arrow; if confirmed, this module can be loaded to realize personalized design of the forefoot area.

7. The method for realizing intelligent digital modularization of customized orthopedic insoles according to claim 6, characterized in that: In the personalized module automatic loading step S5, The modules corresponding to the midfoot area at least include any one of the following functional modules or a combination of multiple functional modules: a small outer half pad functional module, a small transverse arch full pad functional module, a small transverse arch pad functional module, a proprioceptive inner arch pad functional module, a proprioceptive outer transverse arch pad functional module, a proprioceptive transverse arch pad functional module, a transverse arch full pad functional module, a transverse arch pad functional module, a middle arch functional module, a low arch functional module and a high arch functional module; After selecting any corresponding functional module or multiple functional modules according to design requirements, the corresponding modules are automatically loaded into the functional area of ​​the insole; they can be moved left, right, up or down by dragging the arrows; The position of the module is finally determined by displaying the plantar pressure map and the plantar scanning image. If confirmed, the module can be loaded to achieve personalized design of the midfoot area.

8. The method for realizing intelligent digital modularization of customized orthopedic insoles according to claim 7, characterized in that: In the personalized module automatic loading step S5, The modules corresponding to the rear foot area at least include any one of the following functional modules or a combination of multiple functional modules: a heel medial pad functional module, a heel medial tip pad middle functional module, a heel medial tip pad low functional module, a heel medial tip pad high functional module, a heel medial oblique pad functional module, a heel lateral pad functional module, a heel medial tip pad functional module, a heel tip pad functional module, a proprioceptive external arch pad functional module, and a proprioceptive heel cup functional module; After selecting any corresponding functional module or multiple functional modules according to design needs, the corresponding module is automatically loaded into the functional area of ​​the insole; it can be moved left, right, up or down by dragging the arrow; if confirmed, this module can be loaded to realize personalized design of the rear foot area.

9. The method for realizing intelligent digital modularization of customized orthopedic insoles according to any one of claims 1 to 5 or 7 or 8, characterized in that: It also includes digital processing and production, including: Machining programming or slicing processing: convert the designed insole data into processable machining NC files or slicing files; Material selection: Choose matching materials from EVA, TPU or silicone according to the functional requirements of different modules; 3D Sculpting or Additive Manufacturing: CNC milling or 3D printing technology is used to produce customized orthotics according to the machining path file and the selected material; Post-processing: polishing, assembly and performance testing of the finished product.

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