A method, apparatus and appliance for manufacturing a multi-zone integrated silicone orthodontic appliance

Abstract

This application provides a method for manufacturing a multi-zone integrated silicone orthodontic appliance, comprising: acquiring three-dimensional data of a user's jaw and constructing a three-dimensional digital model of the appliance based on the three-dimensional data of the user's jaw; obtaining anatomical location data of teeth and orthodontic biomechanical design data, and dividing the target appliance into functional zones with at least two different hardnesses based on the three-dimensional digital model of the appliance, and assigning a zone hardness value to each functional zone; performing mechanical simulation on the three-dimensional digital model of the appliance, analyzing the stress distribution information of each functional zone acting on the teeth and periodontal tissues under the zone hardness value configuration of the virtual appliance constructed by the three-dimensional digital model of the appliance, so as to optimize the three-dimensional digital model of the appliance based on the stress distribution information feedback; converting the manufacturing data output by the optimized stage three-dimensional digital model of the appliance into manufacturing instructions, and driving a printing device to manufacture the corresponding appliance mold or print the corresponding appliance according to the manufacturing instructions.

Description

Technical Field

[0001] This application relates to the field of orthodontic appliance manufacturing technology, specifically to a method for manufacturing a multi-zone integrated silicone orthodontic appliance, an apparatus for manufacturing a multi-zone integrated silicone orthodontic appliance, and a multi-zone integrated silicone orthodontic appliance. Background Technology

[0002] Silicone is widely used in the field of dental medical devices due to its good biocompatibility, flexibility and ease of processing, such as silicone jaw pads, sports mouthguards and some removable orthodontic appliances.

[0003] Existing silicone braces are typically made of silicone material with a single hardness. However, different parts of the brace have conflicting functional requirements. The occlusal contact area requires high hardness to resist chewing abrasion; specific force application areas for certain teeth require a specific medium hardness to deliver precise and effective orthodontic force; while the base area, which conforms extensively to the soft tissue of the gums, requires low hardness to ensure wearing comfort. Braces made of a single hardness material cannot simultaneously optimize these properties, resulting in products that are prone to wear, inaccurate force control, or poor comfort.

[0004] How to achieve material hardness differentiation and local performance optimization on the same silicone orthodontic appliance according to the functional requirements of each part has become an urgent problem for those skilled in the art. Summary of the Invention

[0005] This application provides a method for manufacturing a multi-zone integrated silicone orthodontic appliance, addressing the problem in the prior art of how to achieve material hardness differentiation and local performance optimization on the same silicone orthodontic appliance according to the functional requirements of each part. This application also provides a manufacturing apparatus for a multi-zone integrated silicone orthodontic appliance and a multi-zone integrated silicone orthodontic appliance.

[0006] This application provides a method for manufacturing a multi-zone integrated silicone orthodontic appliance, including: Acquire three-dimensional data of the user's jaw and construct a three-dimensional digital model of the orthodontic appliance based on the three-dimensional data of the user's jaw; Obtain tooth anatomical location data and orthodontic biomechanical design data, and based on the three-dimensional digital model of the orthodontic appliance, divide the target orthodontic appliance into functional areas with at least two different hardnesses, and assign a partition hardness value to each functional area. Mechanical simulation was performed on the three-dimensional digital model of the orthodontic appliance to analyze the stress distribution information of each functional area of ​​the virtual orthodontic appliance constructed by the three-dimensional digital model of the orthodontic appliance under the configuration of zoned hardness values, so as to optimize the three-dimensional digital model of the orthodontic appliance based on the stress distribution information. The manufacturing data output from the optimized three-dimensional digital model of the staged orthodontic appliance is converted into manufacturing instructions, and the printing equipment is driven to manufacture the corresponding orthodontic appliance mold or print the corresponding orthodontic appliance according to the manufacturing instructions.

[0007] Optionally, obtaining tooth anatomical location data and orthodontic biomechanical design data includes: The oral cavity is scanned to obtain anatomical position data of the teeth; the anatomical position data of the teeth refers to the geometric shape, spatial coordinates, orientation vector of each tooth in three-dimensional space and its relative position with adjacent teeth, the jaw plane, and the jawbone; The target position of the tooth is set, and the tooth movement vector is obtained by combining the tooth anatomical position data; The orthodontic biomechanics design data are determined based on the movement vector.

[0008] Optionally, the step of obtaining tooth anatomical location data and orthodontic biomechanical design data, and dividing the target orthodontic appliance into functional areas with at least two different hardnesses based on the three-dimensional digital model of the appliance, includes: Based on tooth anatomical location data and orthodontic biomechanical design data, the surface of the orthodontic appliance under the three-dimensional digital model of the appliance is divided into at least two functional areas; The type of each functional area is determined based on the corresponding tooth / location and the required mechanical properties of the corresponding tooth / location; The hardness grade of the building material for each functional area is determined according to its type. Using materials with selectable hardness, the mechanical simulation of the three-dimensional digital model of the orthodontic appliance is performed. The stress distribution information of the virtual orthodontic appliance constructed from the three-dimensional digital model, acting on the teeth and periodontal tissues in each functional area under the configured hardness values ​​of the zones, is analyzed. The three-dimensional digital model of the orthodontic appliance is then fed back and optimized based on the stress distribution information. This includes: Using a preset analysis method, the stress distribution, force transmission to teeth, and pressure on soft tissue of each functional area of ​​the virtual orthodontic appliance are simulated under different hardness configurations. The hardness values ​​of each functional area are adjusted iteratively until the mechanical properties reach the optimal balance.

[0009] Optionally, the three-dimensional digital model of the orthodontic appliance divides the target orthodontic appliance into functional areas with at least two different hardnesses, including: a highly wear-resistant occlusal contact area and a low-hardness soft tissue contact area.

[0010] Optionally, the three-dimensional digital model of the orthodontic appliance divides the target orthodontic appliance into functional areas with at least two different hardnesses, and also includes a transition area for precise force application. The hardness value of the transition area is between the hardness values ​​of the high-wear-resistant occlusal contact area and the low-hardness soft tissue contact area, so as to divide the functional areas of the target orthodontic appliance into multi-hardness gradient zones.

[0011] Optionally, the step of driving the printing equipment to manufacture the corresponding orthodontic mold or print the corresponding orthodontic appliance according to the manufacturing instructions includes: The manufacturing instructions drive the printing equipment to manufacture a corresponding orthodontic appliance mold. The orthodontic appliance mold has at least two partitioned cavities, and these at least two partitioned cavities can be used to injection mold at least two functional areas of the target orthodontic appliance with different hardness; or Print an orthodontic appliance with at least two functional areas of different hardness.

[0012] Optionally, the manufacturing instructions may also include a sequential injection co-curing process or a layered injection curing process.

[0013] This application also provides a multi-zone integrated silicone orthodontic appliance manufacturing device, including: an orthodontic appliance three-dimensional digital model construction unit, used to acquire three-dimensional data of the user's jaw and construct a three-dimensional digital model of the orthodontic appliance based on the three-dimensional data of the user's jaw; The functional area division unit is used to obtain tooth anatomical location data and orthodontic biomechanical design data, and to divide the target orthodontic appliance into functional areas with at least two different hardnesses based on the three-dimensional digital model of the appliance, and to assign a partition hardness value to each functional area. The mechanical simulation unit is used to perform mechanical simulation on the three-dimensional digital model of the orthodontic appliance, analyze the stress distribution information of each functional area of ​​the virtual orthodontic appliance constructed by the three-dimensional digital model of the orthodontic appliance under the configuration of the zoned hardness value, and optimize the three-dimensional digital model of the orthodontic appliance based on the stress distribution information. The manufacturing unit is used to convert the manufacturing data output from the optimized three-dimensional digital model of the staged orthodontic appliance into manufacturing instructions, and drive the printing equipment to manufacture the corresponding orthodontic appliance mold or print the corresponding orthodontic appliance according to the manufacturing instructions.

[0014] The application also provides a multi-zone integrated silicone orthodontic appliance, which is manufactured by the multi-zone integrated silicone orthodontic appliance manufacturing method described above, and the multi-zone integrated silicone orthodontic appliance has at least two functional areas with different hardness.

[0015] Compared with the prior art, this application has the following advantages: This application provides a method for manufacturing a multi-zone integrated silicone orthodontic appliance, including: Attached Figure Description

[0016] The process involves acquiring three-dimensional data of the user's jaw and constructing a three-dimensional digital model of the orthodontic appliance based on this data; obtaining anatomical location data and orthodontic biomechanical design data for the teeth; dividing the target orthodontic appliance into functional regions with at least two different hardnesses based on the three-dimensional digital model of the appliance, and assigning a partition hardness value to each functional region; performing mechanical simulation on the three-dimensional digital model of the appliance to analyze the stress distribution information of each functional region acting on the teeth and periodontal tissues under the partition hardness value configuration, so as to optimize the three-dimensional digital model of the appliance based on the stress distribution information; converting the manufacturing data output from the optimized three-dimensional digital model of the appliance into manufacturing instructions, and driving the printing equipment to manufacture the corresponding appliance mold or print the corresponding appliance according to the manufacturing instructions.

[0017] This application's method for manufacturing multi-zone integrated silicone orthodontic appliances can be understood as follows: It constructs a three-dimensional digital model of the appliance using three-dimensional data of the user's jaw, and divides the target appliance into at least two functional zones with different hardnesses based on tooth anatomical location data and orthodontic biomechanical design data. This fundamentally solves the contradiction that a single material cannot simultaneously achieve wear resistance, precise force application, and comfort. Furthermore, the introduction of the functional zoning concept allows for quantitative design and optimization using mechanical simulation tools, shifting product design from experience-driven to performance-driven. Moreover, the use of integrated molding technology ensures good fusion of different hardness zones at the interface, avoiding the risks of delamination and detachment, resulting in greater product structural integrity and lifespan.

[0018] Figure 1 A flowchart illustrating a method for manufacturing a multi-zone integrated silicone orthodontic appliance according to the first embodiment of this application.

[0019] Figure 2 A flowchart of a multi-zone integrated silicone orthodontic appliance manufacturing apparatus provided for the second embodiment of this application.

[0020] Figure 3 This is a structural schematic diagram of a multi-zone integrated silicone orthodontic appliance provided in the third embodiment of this application. Detailed Implementation

[0021] Many specific details are set forth in the following description to provide a full understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar extensions without departing from the spirit of this application; therefore, this application is not limited to the specific embodiments disclosed below.

[0022] In the description of this application, it should be understood that the terms "upper", "lower", "left", "right", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0023] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0024] Silicone is widely used in the field of dental medical devices due to its good biocompatibility, flexibility and ease of processing, such as silicone jaw pads, sports mouthguards and some removable orthodontic appliances.

[0025] Existing silicone braces are typically made of silicone material with a single hardness. However, different parts of the brace have conflicting functional requirements. The occlusal contact area requires high hardness to resist chewing abrasion; specific force application areas for certain teeth require a specific medium hardness to deliver precise and effective orthodontic force; while the base area, which conforms extensively to the soft tissue of the gums, requires low hardness to ensure wearing comfort. Braces made of a single hardness material cannot simultaneously optimize these properties, resulting in products that are prone to wear, inaccurate force control, or poor comfort.

[0026] Accordingly, this application provides a method for manufacturing a multi-zone integrated silicone orthodontic appliance, to solve the problem in the prior art of how to achieve material hardness differentiation and local performance optimization on the same silicone orthodontic appliance according to the functional requirements of each part. This application also provides a manufacturing apparatus for a multi-zone integrated silicone orthodontic appliance and a multi-zone integrated silicone orthodontic appliance.

[0027] The present application will be described in detail below with reference to specific embodiments and accompanying drawings.

[0028] First Embodiment The first embodiment of this application provides a method for manufacturing a multi-zone integrated silicone orthodontic appliance, which is described below in conjunction with... Figure 1 The manufacturing method of this multi-zone integrated silicone orthodontic appliance is described in detail. Figure 1 This is a flowchart illustrating a method for manufacturing a multi-zone integrated silicone orthodontic appliance according to the first embodiment of this application. The method includes the following steps: Step S101: Obtain three-dimensional data of the user's jaw and construct a three-dimensional digital model of the orthodontic appliance based on the three-dimensional data of the user's jaw.

[0029] Specifically, the system scans and collects images of the user's maxillary and mandibular dentitions and corresponding occlusal records. Specifically, it obtains the length and width information of the maxillary and mandibular dentitions, the morphological information of the labial / buccal and lingual contours of the maxillary and mandibular dentitions, and the gingival position information of each tooth in the maxillary and mandibular dentitions. In one example, the width information of each maxillary and mandibular dentition can be calculated and fitted using incisor width, intercanine width, and intermolar width. Simultaneously with obtaining the incisor width, intercanine width, and intermolar width, the corresponding positional information of each incisor, canine, and molar can be obtained. Based on the incisor width, intercanine width, and intermolar width and their corresponding positional information, the length information of the maxillary and mandibular dentitions is obtained. Then, based on the length and width information of the maxillary and mandibular dentitions, the distance between the relative occlusal surfaces of the maxillary and mandibular dentitions is obtained. The distance between the occlusal surfaces clearly indicates the degree of maxillary and mandibular opening. In one example, the morphology of the labial / buccal and lingual contours of the upper and lower dentitions, as well as the gingival position of each tooth in the upper and lower dentitions, is obtained. Then, the morphology of the labial / buccal and lingual contours and the gingival positions of each tooth are smoothed by connecting lines to determine the standard morphology after processing. For example, based on the smoothed gingival position lines between two teeth in different dentition regions (such as incisors, canines, molars, etc.), the outer wall length of the digital model of the orthodontic appliance is fitted and adjusted. The outer wall length is sufficient to ensure that the appliance does not compress the gingiva; if the outer wall length of the appliance does not reach the gingival position, it is incorrect. Finally, based on the length and width information of the upper and lower dentitions, the morphological information of the labial / buccal and lingual contours of the upper and lower dentitions, and the gingival position information of each tooth in the upper and lower dentitions, the corresponding dental images are obtained. Then, dental software is used to convert the point coordinates in the dental images into three-dimensional spatial coordinates and generate three-dimensional data of the user's dental jaw.

[0030] After acquiring the user's three-dimensional dentition data, a three-dimensional digital model of the orthodontic appliance can be constructed based on this data. Specifically, an initial three-dimensional digital model of the orthodontic appliance is constructed, its parameters are set, and the three-dimensional data is labeled and processed (as sample data) and then input into the initial three-dimensional digital model for iterative training. The output of the initial three-dimensional digital model is compared with the preset appliance morphology data. If the comparison results are consistent, the initial three-dimensional digital model is determined as the orthodontic appliance three-dimensional digital model; if the comparison results are inconsistent, the three-dimensional data continues to be input into the initial three-dimensional digital model for iterative training until the output results are consistent with the appliance morphology data.

[0031] Step S102: Obtain tooth anatomical location data and orthodontic biomechanical design data, and based on the three-dimensional digital model of the orthodontic appliance, divide the target orthodontic appliance into functional areas with at least two different hardnesses, and assign a partition hardness value to each functional area.

[0032] In this step, obtaining tooth anatomical location data and orthodontic biomechanical design data includes: first, scanning the oral cavity to obtain tooth anatomical location data. This data includes the geometric shape, spatial coordinates, direction vector, and relative relationship of each tooth to adjacent teeth, the occlusal plane, and the jawbone in three-dimensional space. In one example, the tooth anatomical location data includes not only the crown shape but also the root orientation, long axis direction, and tilt / torsion angle.

[0033] Then, the target position of the teeth is set, and the movement vector of the teeth is obtained by combining the anatomical position data of the teeth. Based on clinical diagnosis, aesthetic analysis, functional occlusion principles, and individual patient needs, the AI-assisted system (orthodontic software, a type of computer software specifically designed to assist orthodontists in diagnosis, treatment planning, tooth movement simulation, and appliance design. This software typically integrates 3D modeling, biomechanical analysis, artificial intelligence, and manufacturing interfaces) sets the target position for each tooth to be moved in three-dimensional space. This target position includes not only the ideal alignment of the teeth in the dental arch (such as alignment or leveling) but also its three-dimensional directional parameters, which include at least: mesiodistal parameters (anterior-posterior movement), buccolingual parameters (interior-exterior tilt), vertical parameters (intrusion or protrusion), rotation angle parameters (torsion around the long axis of the tooth), and torque parameters (inclination of the root relative to the crown). It should be noted that setting the target position of the teeth must conform to the Andrews six criteria for normal occlusion, Bolton index compatibility, and other orthodontic biomechanical principles, while also considering periodontal health and temporomandibular joint function.

[0034] After setting the target position of the teeth, the tooth movement vector is obtained by combining the anatomical position data. Specifically, using the crown center point or the long axis of the tooth as a reference, the initial anatomical position of each tooth is spatially registered with its target position. The movement vector required for the tooth to move from its initial position to its terminal position is calculated through three-dimensional coordinate transformation (translation + rotation). This movement vector is a six-degree-of-freedom composite motion description, containing three translational components (Δx, Δy, Δz) and three rotational components (angular displacement about the x, y, and z axes). This movement vector precisely quantifies the spatial displacement path that the tooth needs to complete during treatment.

[0035] Finally, the orthodontic biomechanics design data is determined based on the movement vector. Specifically, the optimal location and vector direction for applying force to the crown surface are determined based on the movement vector to effectively transmit torque to the periodontal ligament. The magnitude and type of orthodontic force are also determined based on the movement vector, for example, differentiating between different modes such as translation (overall movement), tilting, and root-controlled movement, and matching corresponding light forces (typically 0.1–0.3 MPa) or torques. The attachment design is also determined based on the movement vector: for example, if enhanced retention or control of specific movements (such as rotation or intrusion) is required, resin attachments with optimized shapes and positions (such as optimized attachments, vertical rectangular attachments, etc.) are designed on the corresponding tooth surfaces. Finally, the appliance deformation parameters are determined based on the movement vector. In invisible orthodontic systems, the movement vector is converted into thermoplastic material, whose pre-defined deformation during manufacturing ensures the expected elastic recovery force after wearing.

[0036] After obtaining tooth anatomical location data and orthodontic biomechanical design data, and based on the three-dimensional digital model of the orthodontic appliance, the target appliance is divided into at least two functional regions with different hardnesses. This includes: First, based on the tooth anatomical location data and orthodontic biomechanical design data, the surface of the orthodontic appliance under the three-dimensional digital model is divided into at least two functional regions. Then, the type of each functional region is determined according to the corresponding tooth / location and the required mechanical properties of the corresponding tooth / location. The relationship between the corresponding tooth / location, the required mechanical properties of the corresponding tooth / location, and the type of each functional region is shown in the table below: Finally, the hardness grade of the building materials for each functional area is determined according to its type, and functional areas with different hardnesses are constructed using building materials of the corresponding hardness grades. In one example, the hardness grades of the building materials for each functional area include ultra-soft, soft, medium, hard, and ultra-hard. The corresponding Shore A hardnesses for each hardness grade are as follows: ultra-soft grade: Shore A range 10A-30A; soft grade: Shore A range 30A-50A; medium grade: Shore A range 50A-70A; hard grade: Shore A range 70A-85A; and ultra-hard grade: Shore A range greater than 85A.

[0037] In this embodiment, the three-dimensional digital model of the orthodontic appliance divides the target appliance into functional areas with at least two different hardnesses: a highly wear-resistant occlusal contact area (functional area A) and a low-hardness soft tissue contact area (functional area B). In one example, the three-dimensional digital model of the orthodontic appliance further divides the target appliance into functional areas with at least two different hardnesses, including a transition area (functional area C) for precise force application. The hardness value of the transition area is between the hardness values ​​of the highly wear-resistant occlusal contact area and the low-hardness soft tissue contact area, thus dividing the functional areas of the target orthodontic appliance into multi-hardness gradient zones. This gradient hardness design avoids breakage or discomfort caused by sudden stress changes. The advantages of this design are, for example, that the high hardness of the occlusal area ensures product durability, the low hardness of the base area significantly improves comfort and patient compliance, and the specific hardness of the force application area makes the orthodontic force more precise and controllable.

[0038] It should be added that the functional areas in the orthodontic appliance can be regular or irregular, and the functional areas are not limited to a plane, but are more of a three-dimensional area.

[0039] After constructing the three-dimensional digital model of the orthodontic appliance, in order to ensure that the silicone orthodontic appliances with different functional areas produced by the three-dimensional digital model of the orthodontic appliance better meet the orthodontic needs, it is also necessary to conduct mechanical analysis on the three-dimensional digital model of the orthodontic appliance.

[0040] Specifically, in this embodiment, a mechanical simulation is performed on the three-dimensional digital model of the orthodontic appliance. The stress distribution information of each functional area of ​​the virtual orthodontic appliance constructed from the three-dimensional digital model, acting on the teeth and periodontal tissues under different hardness configurations, is analyzed. This stress distribution information is then used to feed back and optimize the three-dimensional digital model of the orthodontic appliance. Further, this step includes: first, using a preset analysis method, simulating the stress distribution, force transmission to the teeth, and pressure on soft tissues of each functional area of ​​the virtual orthodontic appliance under different hardness configurations. Specifically, first, the environmental conditions of each functional area of ​​the orthodontic appliance under the three-dimensional digital model during wear are determined, including at least the mechanical properties of the periodontal tissues. A preset analysis method is then used to simulate the functional areas of the appliance during wear. In one example, the preset analysis method includes finite element analysis or linear emission analysis. Specifically, simulating the functional areas of the appliance during wear using the preset analysis method includes: using orthodontic appliance data, adjacent tooth data, periodontal ligament data, alveolar bone data, etc., to construct an initial data finite element model. Then, displacement or force boundary conditions are applied, for example, by moving the appliance onto the current dentition (i.e., applying a displacement boundary consistent with the designed displacement), and the resulting orthodontic force is calculated. Alternatively, contact forces generated by material rebound can be applied directly. Subsequently, the initial data finite element model outputs key indicators, including: stress / strain distribution: identifying tension zones (bone resorption) and pressure zones (bone deposition) in the periodontal ligament; magnitude and direction of orthodontic force: quantifying the three-dimensional force and torque on each target tooth; tooth displacement prediction: predicting the actual achievable displacement at this stage; and appliance fit analysis: assessing the risk of clinical problems such as marginal lifting and local dislocation. Finally, multi-stage iterative optimization is performed. If the simulation at a certain stage shows excessive force (potentially leading to root resorption) or insufficient displacement, feedback is used to adjust the design for the next stage (e.g., adding overcorrection, adding attachments, optimizing thickness) to obtain the data finite element model.

[0041] Then, the stress distribution, force transmission to teeth, and pressure on soft tissue of each functional area of ​​the virtual orthodontic appliance were simulated under different hardness configurations. Finally, the hardness values ​​of each functional area were iteratively adjusted until the mechanical properties (such as occlusal surface stress, orthodontic force, and mucosal pressure) reached an optimal balance.

[0042] After determining the three-dimensional digital model of the staged orthodontic appliance, the manufacturing data output from the optimized three-dimensional digital model of the staged orthodontic appliance is converted into manufacturing instructions, and the printing equipment is driven to manufacture the corresponding orthodontic appliance mold or print the corresponding orthodontic appliance according to the manufacturing instructions.

[0043] The manufacturing process, which involves driving a printing device to manufacture a corresponding orthodontic appliance mold or printing a corresponding orthodontic appliance according to the manufacturing instructions, includes: driving the printing device to manufacture a corresponding orthodontic appliance mold according to the manufacturing instructions. The orthodontic appliance mold has at least two partitioned cavities, and these at least two partitioned cavities can be used to injection mold at least two functional areas of the target orthodontic appliance with different hardnesses. In this embodiment, the manufacturing instructions also include a sequential injection co-curing process or a layered injection curing process. Taking the printing of an orthodontic appliance mold with three partitioned cavities as an example, the orthodontic appliance is manufactured by first injecting high-hardness silicone into cavity A of the mold, followed by a brief pre-curing. Then, medium-hardness silicone is injected into cavity B, and finally, low-hardness silicone is injected into cavity C. During the final thermal curing cycle, the silicones of different hardnesses undergo a cross-linking reaction at the interface, fusing into a seamless integral component. After demolding, the appliance is trimmed, polished, cleaned, and disinfected to obtain the final orthodontic appliance. The use of integrated molding technology ensures good fusion of different hardness areas at the interface, avoiding the risks of delamination and debonding, resulting in higher product structural integrity and service life.

[0044] Alternatively, print at least two functional areas of different hardness on the orthodontic appliance. Specifically, first print high-hardness silicone on functional area A of the orthodontic appliance, and after a short pre-curing period, print medium-hardness silicone on functional area B of the orthodontic appliance, and finally print low-hardness silicone on functional area C of the orthodontic appliance.

[0045] In this embodiment, it can also be achieved by locally adding reinforcing fibers or particles to the silicone matrix (limited to high-hardness areas), but biocompatibility must be ensured.

[0046] In this embodiment, the silicone orthodontic appliance contains fluoride.

[0047] This application provides a method for manufacturing a multi-zone integrated silicone orthodontic appliance, including: The process involves acquiring three-dimensional data of the user's jaw and constructing a three-dimensional digital model of the orthodontic appliance based on this data; obtaining anatomical location data and orthodontic biomechanical design data for the teeth; dividing the target orthodontic appliance into functional regions with at least two different hardnesses based on the three-dimensional digital model of the appliance, and assigning a partition hardness value to each functional region; performing mechanical simulation on the three-dimensional digital model of the appliance to analyze the stress distribution information of each functional region acting on the teeth and periodontal tissues under the partition hardness value configuration, so as to optimize the three-dimensional digital model of the appliance based on the stress distribution information; converting the manufacturing data output from the optimized three-dimensional digital model of the appliance into manufacturing instructions, and driving the printing equipment to manufacture the corresponding appliance mold or print the corresponding appliance according to the manufacturing instructions.

[0048] This application's method for manufacturing multi-zone integrated silicone orthodontic appliances can be understood as follows: It constructs a three-dimensional digital model of the appliance using three-dimensional data of the user's jaw, and divides the target appliance into at least two functional zones with different hardnesses based on tooth anatomical location data and orthodontic biomechanical design data. This fundamentally solves the contradiction that a single material cannot simultaneously achieve wear resistance, precise force application, and comfort. Furthermore, the introduction of the functional zoning concept allows for quantitative design and optimization using mechanical simulation tools, shifting product design from experience-driven to performance-driven. Moreover, the use of integrated molding technology ensures good fusion of different hardness zones at the interface, avoiding the risks of delamination and detachment, resulting in greater product structural integrity and lifespan.

[0049] Second Embodiment The first embodiment of this application provides a method for a multi-zone integrated silicone orthodontic appliance. Correspondingly, the second embodiment of this application also provides a device for a multi-zone integrated silicone orthodontic appliance. Since the device embodiment is basically similar to the first method embodiment, the description is relatively simple; relevant details can be found in the description of the method embodiment. The device embodiments described below are merely illustrative.

[0050] Please refer to Figure 2 , Figure 2 This is a schematic diagram of a multi-zone integrated silicone orthodontic appliance device provided in the second embodiment of this application.

[0051] This multi-zone integrated silicone orthodontic appliance includes: The three-dimensional digital model construction unit 201 for orthodontic appliances is used to acquire three-dimensional data of the user's teeth and jaws and construct a three-dimensional digital model of the orthodontic appliance based on the three-dimensional data of the user's teeth and jaws. The functional area division unit 202 is used to obtain tooth anatomical location data and orthodontic biomechanical design data, and divide the target orthodontic appliance into functional areas with at least two different hardnesses based on the three-dimensional digital model of the appliance, and assign a partition hardness value to each functional area. The mechanical simulation unit 203 is used to perform mechanical simulation on the three-dimensional digital model of the orthodontic appliance, analyze the stress distribution information of each functional area of ​​the virtual orthodontic appliance constructed by the three-dimensional digital model of the orthodontic appliance under the configuration of the partition hardness value, and optimize the three-dimensional digital model of the orthodontic appliance based on the stress distribution information. Manufacturing unit 204 is used to convert the manufacturing data output from the optimized three-dimensional digital model of the staged orthodontic appliance into manufacturing instructions, and drive the printing equipment to manufacture the corresponding orthodontic appliance mold or print the corresponding orthodontic appliance according to the manufacturing instructions.

[0052] Third Embodiment In the first embodiment described above, a method for manufacturing a multi-zone integrated silicone orthodontic appliance is provided. Correspondingly, the third embodiment of this application provides a multi-zone integrated silicone orthodontic appliance, manufactured using the aforementioned method. Figure 3 As shown, Figure 3 This is a schematic diagram of a multi-zone integrated silicone orthodontic appliance provided in the third embodiment of this application. The multi-zone integrated silicone orthodontic appliance 300 has at least two functional areas with different hardness.

[0053] It should be noted that although several structures, components, or units for implementing the relevant functions have been mentioned in the detailed description above, this division is not mandatory. In fact, according to the specific embodiments of this application, the features and functions of two or more structures, components, or units described above can be embodied in one structure, component, or unit. Conversely, the features and functions of one structure, component, or unit described above can be further divided and embodied by multiple components, structures, or units.

[0054] Furthermore, although the various components of the components or apparatus in this application and the mounting arrangements between them are described in a specific order in the accompanying drawings, this does not require or imply that the components or apparatus must be designed according to that specific component or mounting arrangement, or that all the components shown must be included to achieve the desired result. Additional or alternative components may be omitted, multiple components may be combined into one component to achieve the corresponding function, and / or a component may be decomposed into multiple components to achieve the corresponding function, etc.

[0055] Although this application discloses preferred embodiments as described above, it is not intended to limit this application. Any person skilled in the art can make possible changes and modifications without departing from the spirit and scope of this application. Therefore, the scope of protection of this application should be determined by the scope defined in the claims of this application.

[0056] In a typical configuration, a computing device includes one or more processors (CPUs), input / output interfaces, network interfaces, and memory.

[0057] Memory may include non-persistent storage in computer-readable media, such as random access memory (RAM) and / or non-volatile memory, such as read-only memory (ROM) or flash RAM. Memory is an example of computer-readable media.

[0058] 1. Computer-readable media includes both permanent and non-permanent, removable and non-removable media that can store information by any method or technology. Information can be computer-readable instructions, data structures, program modules, or other data. Examples of computer storage media include, but are not limited to, phase-change memory (PRAM), static random access memory (SRAM), dynamic random access memory (DRAM), other types of random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), flash memory or other memory technologies, CD-ROM, digital versatile optical disc (DVD) or other optical storage, magnetic tape, magnetic magnetic disk storage or other magnetic storage devices, or any other non-transferable medium that can be used to store information accessible by a computing device. As defined herein, computer-readable media does not include non-transitory computer-readable media, such as modulated data signals and carrier waves.

[0059] 2. Those skilled in the art will understand that embodiments of this application can be provided as methods, systems, or computer program products. Therefore, this application can take the form of a completely hardware embodiment, a completely software embodiment, or an embodiment combining software and hardware aspects. Furthermore, this application can take the form of a computer program product embodied on one or more computer-usable storage media (including but not limited to disk storage, CD-ROM, optical storage, etc.) containing computer-usable program code.

[0060] It should be noted that the embodiments of this application may involve the use of user data. In practical applications, user-specific personal data may be used in the scheme described herein within the scope permitted by applicable laws and regulations, provided that it complies with the applicable laws and regulations of the country (e.g., with the user's explicit consent, with the user being properly notified, etc.).

[0061] It should be noted that the user information (including but not limited to user device information, user personal information, etc.) and data (including but not limited to data used for analysis, data stored, data displayed, etc.) involved in this application are all information and data authorized by the user or fully authorized by all parties. Furthermore, the collection, use and processing of the relevant data must comply with the relevant laws, regulations and standards of the relevant countries and regions, and corresponding operation entry points are provided for users to choose to authorize or refuse.

Claims

1. A method for manufacturing a multi-zone integrated silicone orthodontic appliance, characterized in that, include: Acquire three-dimensional data of the user's jaw and construct a three-dimensional digital model of the orthodontic appliance based on the three-dimensional data of the user's jaw; Obtain tooth anatomical location data and orthodontic biomechanical design data, and based on the three-dimensional digital model of the orthodontic appliance, divide the target orthodontic appliance into functional areas with at least two different hardnesses, and assign a partition hardness value to each functional area. Mechanical simulation was performed on the three-dimensional digital model of the orthodontic appliance to analyze the stress distribution information of each functional area of ​​the virtual orthodontic appliance constructed by the three-dimensional digital model of the orthodontic appliance under the configuration of zoned hardness values, so as to optimize the three-dimensional digital model of the orthodontic appliance based on the stress distribution information. The manufacturing data output from the optimized three-dimensional digital model of the staged orthodontic appliance is converted into manufacturing instructions, and the printing equipment is driven to manufacture the corresponding orthodontic appliance mold or print the corresponding orthodontic appliance according to the manufacturing instructions.

2. The method for manufacturing a multi-zone integrated silicone orthodontic appliance according to claim 1, characterized in that, The acquisition of tooth anatomical location data and orthodontic biomechanical design data includes: The oral cavity is scanned to obtain anatomical position data of the teeth; the anatomical position data of the teeth refers to the geometric shape, spatial coordinates, orientation vector of each tooth in three-dimensional space and its relative position with adjacent teeth, the jaw plane, and the jawbone; The target position of the tooth is set, and the tooth movement vector is obtained by combining the tooth anatomical position data; The orthodontic biomechanics design data are determined based on the movement vector.

3. The method for manufacturing a multi-zone integrated silicone orthodontic appliance according to claim 1, characterized in that, The process involves obtaining anatomical location data of the teeth and orthodontic biomechanical design data, and dividing the target orthodontic appliance into functional areas with at least two different hardnesses based on the three-dimensional digital model of the appliance, including: Based on tooth anatomical location data and orthodontic biomechanical design data, the surface of the orthodontic appliance under the three-dimensional digital model of the appliance is divided into at least two functional areas; The type of each functional area is determined based on the corresponding tooth / location and the required mechanical properties of the corresponding tooth / location; The hardness grade of the building materials for each functional area is determined according to the type of each functional area, and the functional areas with different hardness are constructed using building materials of the corresponding hardness grades.

4. The method for manufacturing a multi-zone integrated silicone orthodontic appliance according to claim 1, characterized in that, The mechanical simulation of the three-dimensional digital model of the orthodontic appliance, analyzing the stress distribution information of the virtual orthodontic appliance constructed from the three-dimensional digital model under the configuration of zoned hardness values, and optimizing the three-dimensional digital model of the orthodontic appliance based on the stress distribution information, includes: Using a preset analysis method, the stress distribution, force transmission to teeth, and pressure on soft tissue of each functional area of ​​the virtual orthodontic appliance are simulated under different hardness configurations. The hardness values ​​of each functional area are adjusted iteratively until the mechanical properties reach the optimal balance.

5. The method for manufacturing a multi-zone integrated silicone orthodontic appliance according to claim 1, characterized in that, The three-dimensional digital model of the orthodontic appliance divides the target orthodontic appliance into functional areas with at least two different hardnesses, including: a highly wear-resistant occlusal contact area and a low-hardness soft tissue contact area.

6. The method for manufacturing a multi-zone integrated silicone orthodontic appliance according to claim 5, characterized in that, The three-dimensional digital model of the orthodontic appliance divides the target orthodontic appliance into functional areas with at least two different hardnesses, and also includes a transition area for precise force application. The hardness value of the transition area is between the hardness values ​​of the high-wear-resistant occlusal contact area and the low-hardness soft tissue contact area, so as to divide the functional areas of the target orthodontic appliance into multi-hardness gradient zones.

7. The method for manufacturing a multi-zone integrated silicone orthodontic appliance according to claim 1, characterized in that, The step of driving the printing equipment to manufacture the corresponding orthodontic mold or print the corresponding orthodontic appliance according to the manufacturing instructions includes: The manufacturing instructions drive the printing equipment to manufacture a corresponding orthodontic appliance mold. The orthodontic appliance mold has at least two partitioned cavities, and these at least two partitioned cavities can be used to injection mold at least two functional areas of the target orthodontic appliance with different hardness; or Print an orthodontic appliance with at least two functional areas of different hardness.

8. The method for manufacturing a multi-zone integrated silicone orthodontic appliance according to claim 1, characterized in that, The manufacturing instructions also include sequential injection co-vulcanization or layered injection vulcanization.

9. A manufacturing apparatus for a multi-zone integrated silicone orthodontic appliance, characterized in that, include: The orthodontic appliance three-dimensional digital model construction unit is used to acquire three-dimensional data of the user's teeth and jaws, and construct a three-dimensional digital model of the orthodontic appliance based on the three-dimensional data of the user's teeth and jaws. The functional area division unit is used to obtain tooth anatomical location data and orthodontic biomechanical design data, and to divide the target orthodontic appliance into functional areas with at least two different hardnesses based on the three-dimensional digital model of the appliance, and to assign a partition hardness value to each functional area. The mechanical simulation unit is used to perform mechanical simulation on the three-dimensional digital model of the orthodontic appliance, analyze the stress distribution information of each functional area of ​​the virtual orthodontic appliance constructed by the three-dimensional digital model of the orthodontic appliance under the configuration of the zoned hardness value, and optimize the three-dimensional digital model of the orthodontic appliance based on the stress distribution information. The manufacturing unit is used to convert the manufacturing data output from the optimized three-dimensional digital model of the staged orthodontic appliance into manufacturing instructions, and drive the printing equipment to manufacture the corresponding orthodontic appliance mold or print the corresponding orthodontic appliance according to the manufacturing instructions.

10. A multi-zone integrated silicone orthodontic appliance, characterized in that, The multi-zone integrated silicone orthodontic appliance is manufactured by any one of the manufacturing methods described in 1-8 above, and the multi-zone integrated silicone orthodontic appliance has at least two functional areas with different hardness.

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