A gradient elastic modulus motion protective brace, its preparation method and application

Abstract

This invention relates to a gradient elastic modulus sports protective brace, its preparation method, and its application. The gradient elastic modulus sports protective brace includes at least an impact-resistant layer, a buffer layer, and an adhesive layer with a segmented or continuous gradient distribution of elastic modulus. The adhesive layer is used to adhere to the tooth surface and oral soft tissues, and to help disperse residual impact energy. The buffer layer surrounds the adhesive layer and is used to disperse impact energy. The impact-resistant layer surrounds the buffer layer and is used to resist external impact loads and guide energy inward. The elastic modulus of the impact-resistant layer is greater than that of the buffer layer, and the elastic modulus of the buffer layer is greater than that of the adhesive layer. Compared with existing technologies, this invention, through its gradient elastic modulus distribution design, achieves progressive absorption and effective dissipation of impact energy by the sports brace, significantly reducing the peak force on the user's teeth and periodontal tissues during impact, thereby improving overall protective performance and making it suitable for sports scenarios of varying intensities.

Description

Technical Field

[0001] This invention belongs to the field of oral protective equipment technology, and relates to a gradient elastic modulus motion protective dental brace, its preparation method and application. Background Technology

[0002] Current sports braces are mostly made of homogeneous polymer materials, such as ethylene-vinyl acetate copolymer (EVA), thermoplastic polyurethane elastomer (TPU), or polyolefin elastomer (POE). However, due to the singular mechanical properties of homogeneous materials, it is difficult to achieve a good balance between impact protection and wearing comfort in sports braces. This is manifested in two ways: on the one hand, if a homogeneous material with higher hardness is used, although it can improve impact resistance to a certain extent, it will significantly reduce the fit and comfort of wearing, and long-term wear can easily cause discomfort to the oral mucosa; on the other hand, if a homogeneous material with higher softness is used, although it can optimize the wearing experience, its impact energy absorption capacity is limited. When subjected to external impact, the peak force on the teeth is higher, making it difficult to provide effective protection for the teeth, periodontal tissues, and jawbone. In addition, the current design and development of sports braces has failed to take into account the different force distribution in different parts of the oral cavity to achieve differentiated matching of structure and performance.

[0003] In summary, developing a sports protective brace that can efficiently absorb impact energy, reasonably buffer tooth force, and provide comfortable wear has become an urgent technical problem to be solved in this field. Summary of the Invention

[0004] The purpose of this invention is to overcome the technical defects of existing sports protective mouthguards, which use homogeneous materials, resulting in difficulty in balancing impact protection and wearing comfort, limited impact energy absorption, and excessively high peak force on teeth. This invention provides a gradient elastic modulus sports protective mouthguard. Through the gradient distribution design of elastic modulus, this invention achieves the gradual absorption and dissipation of impact energy, reduces the peak force on teeth, and at the same time ensures a good fit and comfort, meeting the high-efficiency protection needs in sports scenarios.

[0005] The objective of this invention can be achieved through the following technical solutions: One of the technical solutions of the present invention is to provide a gradient elastic modulus motion protective brace, comprising at least an impact-resistant layer, a buffer layer, and an adhesive layer with a segmented or continuous elastic modulus gradient distribution. The bonding layer is used to adhere to the tooth surface and oral soft tissue, and to help disperse residual impact energy; The buffer layer is wrapped around the outside of the bonding layer to disperse impact energy; The impact-resistant layer is wrapped around the outside of the buffer layer to resist external impact loads and guide energy to the inside. The elastic modulus of the impact-resistant layer is greater than that of the buffer layer, and the elastic modulus of the buffer layer is greater than that of the bonding layer.

[0006] In some specific embodiments, the impact-resistant layer, the buffer layer, and the bonding layer are each provided with 2 to 5 sub-layers.

[0007] In some specific implementations, the difference in elastic modulus between two adjacent layers is 1 to 50 MPa.

[0008] In some specific embodiments, the total thickness of the gradient elastic modulus motion protective brace is 2~6 mm.

[0009] In some specific embodiments, the thickness of the impact-resistant layer accounts for 10% to 50% of the total thickness, the thickness of the buffer layer accounts for 30% to 80% of the total thickness, and the thickness of the bonding layer accounts for 10% to 50% of the total thickness.

[0010] The second technical solution of the present invention is to provide a method for preparing a gradient elastic modulus motion protective dental brace as described in one of the above technical solutions, comprising the following steps: S1. Oral cavity 3D data acquisition and working model construction: Three-dimensional raw data of the user's jawbone and dentition are obtained by cone-beam computed tomography (CBCT) and oral scanner. The three-dimensional raw data is then imported into reverse engineering software for data noise reduction, smoothing and model reconstruction. This completes the screening, splicing and optimization of the integrated digital working model of the jawbone and dentition, ensuring that the integrated digital working model of the jawbone and dentition is accurately matched with the user's oral physiological structure. S2, Basic Parameter Preset: Based on the user's oral health status and the impact intensity level of the target type of exercise, the maximum elastic modulus threshold of the bonding layer is determined, and the overall thickness range of the sports brace body is set. For example, the maximum elastic modulus threshold of the adhesive layer can be 10~100 MPa, and the maximum elastic modulus threshold of the adhesive layer can be adaptively increased within the range according to the user's oral sensitivity.

[0011] S3. Initial Model Establishment and Impact Simulation Analysis: Based on the integrated digital working model of the jawbone and dentition constructed in step S1, and combined with the basic parameters preset in step S2, a preliminary three-dimensional structural model of the motion protection brace containing an impact-resistant layer, a buffer layer, and an adhesive layer is established using three-dimensional modeling software. The three-dimensional structural model of the preliminary motion protection brace and the integrated digital working model of the jawbone and dentition are imported into the finite element simulation software. An impact load matching the target motion scene is applied to simulate the impact process in actual motion and obtain the deformation, stress distribution cloud map and peak force data of the teeth in the integrated digital working model of the jawbone and dentition. S4. Gradient parameter optimization and optimal solution selection: Based on the simulation results of step S3, the design parameters of each layer in the three-dimensional structural model of the initial motion protection brace, including the thickness ratio of the impact-resistant layer, the buffer layer, and the bonding layer, the difference in elastic modulus between adjacent layers, or the rate of change of continuous elastic modulus, are adjusted and compared to select the optimal parameter combination. S5, Shaping: Based on the optimal parameter combination obtained from step S4, the thickness and elastic modulus of each layer are determined, and the motion protective brace is formed.

[0012] In some specific embodiments, in step S5, the molding process is selected from any one of co-extrusion molding, hot pressing laminated composite process, or additive manufacturing process.

[0013] The above molding process ensures a strong bond between the interfaces of each layer, eliminating the risk of interlayer delamination.

[0014] In some specific embodiments, in step S5, the material of each layer in the sports protective brace is selected from any one or more combinations of ethylene-vinyl acetate copolymer (EVA), thermoplastic polyurethane elastomer (TPU), polyolefin elastomer (POE), and medical-grade rubber.

[0015] For example: when using polymer materials with different elastic modulus grades for layered composite, the polymer materials are selected from two or more combinations of ethylene-vinyl acetate copolymer (EVA), thermoplastic polyurethane elastomer (TPU), polyolefin elastomer (POE), and medical grade rubber. When using the same polymer substrate, the elastic modulus of each layer can be different by adjusting the material formulation (such as the blending ratio), density, or microstructure parameters (such as porosity). For example, by using EVA materials with different VA contents, the elastic modulus of each layer can be different.

[0016] The third technical solution of the present invention is to provide an application of the gradient elastic modulus motion protective brace as described in one of the above technical solutions in motion scenarios where there is a risk of oral impact.

[0017] In some specific implementations, the sports with a risk of oral impact include boxing, basketball, and rugby.

[0018] Compared with the prior art, the present invention has the following advantages: (1) This invention achieves the gradual absorption and effective dissipation of impact energy by the sports braces through the gradient distribution design of elastic modulus, significantly reducing the peak force on the user's teeth and periodontal tissues when subjected to impact, thereby improving the overall protective performance and making it suitable for sports scenarios of different intensities.

[0019] (2) Based on digital modeling and structural parameter control, this invention can realize personalized design of elastic modulus distribution and layer thickness, and enhance the adaptability and targeting of sports protective braces.

[0020] (3) This invention breaks through the limitations of traditional homogeneous material design and provides a new technical solution for the coordinated optimization of protective performance and comfort in sports protective braces. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the structure of a dental brace designed to protect against gradient elastic modulus motion.

[0022] Figure 2 A schematic diagram of the three-dimensional structural model (A) of the sports protective brace and its structure (B) matching the integrated digital working model of the jawbone and dentition.

[0023] Figure 3 The diagrams are schematic diagrams for finite element simulation analysis of the stress on a motion-protective brace. Figure A is a simplified schematic diagram of the stress on the motion-protective brace omitting the jawbone and dentition, while Figure B is a complete schematic diagram including the jawbone and dentition.

[0024] The diagram is marked as follows: 1-Impact-resistant layer, 2-Buffer layer, 3-Adhesive layer. Detailed Implementation

[0025] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments. These embodiments are based on the technical solution of the present invention and provide detailed implementation methods and specific operating procedures. However, the scope of protection of the present invention is not limited to the following embodiments.

[0026] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the specification of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application.

[0027] One technical solution of the present invention is to provide a gradient elastic modulus motion protective brace, such as... Figure 1 As shown, it includes at least an impact-resistant layer 1, a buffer layer 2, and an adhesive layer 3, which have a segmented or continuous elastic modulus gradient distribution. The bonding layer 3 is used to bond to the tooth surface and oral soft tissue, and to help disperse residual impact energy; The buffer layer 2 is wrapped around the outside of the bonding layer 3 to disperse impact energy; The impact-resistant layer 1 is wrapped around the buffer layer 2 to resist external impact loads and guide energy to the inside. The elastic modulus of the impact-resistant layer 1 is greater than that of the buffer layer 2, and the elastic modulus of the buffer layer 2 is greater than that of the bonding layer 3.

[0028] Preferably, the impact-resistant layer 1, the buffer layer 2, and the bonding layer 3 are each provided with 2 to 5 sub-layers.

[0029] Preferably, the difference in elastic modulus between two adjacent layers is 1~50 MPa.

[0030] Preferably, the total thickness of the gradient elastic modulus motion protective brace is 2~6 mm.

[0031] Preferably, the thickness of the impact-resistant layer 1 accounts for 10% to 50% of the total thickness, the thickness of the buffer layer 2 accounts for 30% to 80% of the total thickness, and the thickness of the bonding layer 3 accounts for 10% to 50% of the total thickness.

[0032] One technical solution of the present invention is a method for preparing a gradient elastic modulus motion protective dental brace as described in one of the above technical solutions, comprising the following steps: S1. Oral cavity 3D data acquisition and working model construction: Three-dimensional raw data of the user's jawbone and dentition are acquired through cone-beam computed tomography (CBCT) and an oral scanner. The raw three-dimensional data is then imported into reverse engineering software (such as Materialise Mimics Research 21.0, Geomagic Wrap 2021, and SOLIDWORKS 2021) to perform routine steps such as data denoising, smoothing, and model reconstruction. This completes the screening, splicing, and optimization of the integrated digital working model of the jawbone and dentition, ensuring that the integrated digital working model of the jawbone and dentition accurately matches the user's oral physiological structure. S2, Basic Parameter Preset: Based on the user's oral health status and the impact intensity level of the target type of exercise, the maximum elastic modulus threshold of the bonding layer 3 is determined, and the overall thickness range of the sports brace body is set. For example, the maximum elastic modulus threshold of the adhesive layer 3 can be 10~100 MPa, and the maximum elastic modulus threshold of the adhesive layer 3 can be adaptively increased within this range according to the user's oral sensitivity.

[0033] S3. Initial Model Establishment and Impact Simulation Analysis: Based on the integrated digital working model of the jawbone and dentition constructed in step S1, and combined with the basic parameters preset in step S2, a preliminary three-dimensional structural model of the motion protection brace containing an impact-resistant layer 1, a buffer layer 2, and an adhesive layer 3 is established using three-dimensional modeling software (such as Geomagic software). like Figure 2 The figures shown are schematic diagrams of the preliminary three-dimensional structural model of the motion protection brace and its matching with the integrated digital working model of the jawbone and dentition.

[0034] The preliminary three-dimensional structural model of the motion protection brace and the integrated digital working model of the jawbone and dentition are imported into finite element simulation software (such as ANSYS Workbench software), and an impact load matching the target motion scene is applied to simulate the impact process in actual motion. The deformation, stress distribution cloud map and peak force data of the teeth in the integrated digital working model of the jawbone and dentition are obtained. like Figure 3 The figure shows the stress situation of the three-dimensional structural model of the motion protection brace itself in the preliminary finite element simulation analysis. S4. Gradient parameter optimization and optimal solution selection: Based on the simulation results of step S3, the design parameters of each layer in the three-dimensional structural model of the initial motion protection brace, including the thickness ratio of impact-resistant layer 1, buffer layer 2, and bonding layer 3, the difference in elastic modulus between adjacent layers, or the rate of change of continuous elastic modulus, are adjusted and compared to select the optimal parameter combination. S5, Shaping: Based on the optimal parameter combination obtained from step S4, the thickness and elastic modulus of each layer are determined, and the motion protective brace is formed.

[0035] Preferably, in step S5, the molding process is selected from any one of co-extrusion molding, hot pressing laminated composite process, or additive manufacturing process.

[0036] The above molding process ensures a strong bond between the interfaces of each layer, eliminating the risk of interlayer delamination.

[0037] Preferably, in step S5, the material of each layer in the sports protective brace is selected from any one or more combinations of ethylene-vinyl acetate copolymer (EVA), thermoplastic polyurethane elastomer (TPU), polyolefin elastomer (POE), and medical-grade rubber.

[0038] For example: when using polymer materials with different elastic modulus grades for layered composite, the polymer materials are selected from two or more combinations of ethylene-vinyl acetate copolymer (EVA), thermoplastic polyurethane elastomer (TPU), polyolefin elastomer (POE), and medical grade rubber. When using the same polymer substrate, the elastic modulus of each layer can be made different by adjusting the material formulation (such as the blending ratio), density, or microstructure parameters (such as porosity). For example, by using EVA materials with different VA contents, the elastic modulus of each layer can be made different.

[0039] One technical solution of the present invention is to provide a gradient elastic modulus motion protective brace as described in one of the above technical solutions for use in sports scenarios where there is a risk of oral impact.

[0040] Preferably, the sports with a risk of oral impact include boxing, basketball, and rugby.

[0041] Unless otherwise specified, all embodiments and optional embodiments of this application can be combined to form new technical solutions. Unless otherwise specified, all technical features and optional technical features of this application can be combined to form new technical solutions.

[0042] In the following embodiments, unless otherwise specified, the functional components or structures are conventional components or structures used in the art to achieve the corresponding functions.

[0043] Example 1: This embodiment provides a gradient elastic modulus sports protective mouthguard for high-intensity impact scenarios (boxing), including the following preparation method: 1. Obtain the user's jawbone and dentition raw data through cone-beam computed tomography (CBCT) and an oral scanner. Then, use Materialise Mimics Research 21.0, Geomagic Wrap 2021 and SOLIDWORKS 2021 software to complete the screening, optimization and reconstruction of the integrated digital working model of the jawbone and dentition, ensuring that the working model is accurately matched with the user's oral physiological structure, and then 3D print the working model.

[0044] 2. The user has good oral health and no tooth sensitivity or loosening issues. The maximum elastic modulus of the preset bonding layer 3 is 50MPa. For boxing scenarios with an impact load of 800-1000N, the total thickness of the sports mouthguard is set to 6 mm.

[0045] 3. A three-dimensional model of the motion-protective brace, comprising three functional layers—impact-resistant layer 1, buffer layer 2, and bonding layer 3—was constructed using Geomagic software. This model was then imported into ANSYS Workbench software for finite element simulation analysis. By comparing the tooth deformation and peak surface stress in the working model, the optimal parameter combination was selected: Impact-resistant layer 1 is made of high-hardness thermoplastic polyurethane elastomer (TPU) with a thickness of 2 mm; Buffer layer 2 is made of ethylene-vinyl acetate copolymer (EVA) with a vinyl acetate (VA) content of 28% with a thickness of 2 mm; Bonding layer 3 is made of soft EVA with a VA content of 38% with a thickness of 2 mm. The elastic modulus decreases sequentially from the outside to the inside, satisfying an elastic modulus difference of 1~50 MPa between adjacent layers.

[0046] 4. Prepare circular diaphragms of the corresponding materials according to the above parameters. Use a hot-pressing laminated composite process to press the three layers of diaphragms onto the pre-prepared working model in sequence using a positive pressure pressing machine. After pressing, the diaphragms are trimmed, ground and polished to remove edge burrs and optimize surface smoothness, and finally obtain a gradient elastic modulus motion protective dental brace suitable for high-intensity impact scenarios.

[0047] The gradient elastic modulus motion protective brace was worn on the working model, and its performance was tested using a 1000 N load. The tooth deformation and stress data on the working model are shown in the table below: Conventional sports braces are made of EVA material with a VA content of 28% and a thickness of 6 mm.

[0048] Example 2 This embodiment provides a gradient elastic modulus sports protective mouthguard for low-to-medium intensity impact scenarios (basketball), comprising the following preparation method: 1. Oral 3D Data Acquisition and Model Construction: The user's jawbone and dentition are acquired using cone-beam computed tomography (CBCT) and an oral scanner. Materialise Mimics Research 21.0, Geomagic Wrap 2021 and SOLIDWORKS 2021 software are used in sequence to complete the screening, optimization and reconstruction of the integrated digital model of the jawbone and dentition, ensuring that the model accurately matches the user's oral physiological structure, and a working model is 3D printed.

[0049] 2. The user has mild tooth sensitivity. For the impact load requirement of 350-600 N in basketball scenarios, the elastic modulus of the bonding layer 3 (innermost layer) is preset to correspond to 38% VA content EVA, and the total thickness of the sports mouthguard is set to 4 mm.

[0050] 3. A three-dimensional model of the motion-protective brace, comprising three functional layers: impact-resistant layer 1, buffer layer 2, and bonding layer 3, was constructed using Geomagic software. Buffer layer 2 was further divided into two sub-layers, resulting in a total of four layers. This three-dimensional model was then imported into ANSYS Workbench software for finite element simulation analysis. The optimal parameter combination was selected by comparing tooth deformation and peak surface stress in the working model: from the outside in, the EVA content was 20% VA (impact-resistant layer 1), 26% VA (buffer layer 2, first sub-layer), 32% VA (buffer layer 2, second sub-layer), and 38% VA (bonding layer 3), with each layer 1 mm thick. The elastic modulus decreased progressively along the impact transmission path, ensuring the elastic modulus difference between adjacent layers was 1–50 MPa.

[0051] 4. Based on the above parameters, a four-layer integrated EVA circular film with the corresponding VA content is prepared using a co-extrusion molding process, ensuring tight bonding between each layer and sublayer interface to achieve a smooth transition in elastic modulus. Subsequently, the integrated film is pressed onto a pre-prepared working model using a positive pressure molding machine. After pressing, it undergoes trimming, grinding, and polishing to remove edge burrs and optimize surface finish, ultimately resulting in a gradient elastic modulus sports protective mouthguard suitable for low- to medium-intensity impact scenarios. The mouthguard fits snugly without causing sensitivity or irritation, meeting the daily protective needs of basketball players.

[0052] The gradient elastic modulus motion protective brace was worn on the working model, and its performance was tested using a 1000 N load. The tooth deformation and stress data on the working model are shown in the table below: Conventional sports braces are made of EVA material with a VA content of 28% and a thickness of 4 mm.

[0053] The above description of the embodiments is provided to enable those skilled in the art to understand and use the invention. It will be apparent to those skilled in the art that various modifications can be made to these embodiments, and the general principles described herein can be applied to other embodiments without inventive effort. Therefore, the present invention is not limited to the above embodiments, and any improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the invention should be within the protection scope of the present invention.

Claims

1. A gradient elastic modulus motion protective brace, characterized in that, It includes at least an impact-resistant layer (1), a buffer layer (2), and an adhesive layer (3) with a segmented or continuous elastic modulus gradient distribution. The bonding layer (3) is used to bond to the tooth surface and oral soft tissue, and to help disperse residual impact energy; The buffer layer (2) is wrapped around the adhesive layer (3) to disperse impact energy; The impact-resistant layer (1) is wrapped around the buffer layer (2) to resist external impact loads and guide energy to the inside. The elastic modulus of the impact-resistant layer (1) is greater than that of the buffer layer (2), and the elastic modulus of the buffer layer (2) is greater than that of the bonding layer (3).

2. The gradient elastic modulus motion protective brace according to claim 1, characterized in that, The impact-resistant layer (1), buffer layer (2) and bonding layer (3) are each provided with 2 to 5 sub-layers.

3. The gradient elastic modulus motion protective brace according to claim 2, characterized in that, The difference in elastic modulus between two adjacent layers is 1~50 MPa.

4. The gradient elastic modulus motion protective dental brace according to claim 1, characterized in that, The total thickness of the gradient elastic modulus motion protective brace is 2~6 mm.

5. The gradient elastic modulus motion protective dental brace according to claim 4, characterized in that, The thickness of the impact-resistant layer (1) accounts for 10% to 50% of the total thickness, the thickness of the buffer layer (2) accounts for 30% to 80% of the total thickness, and the thickness of the bonding layer (3) accounts for 10% to 50% of the total thickness.

6. A method for preparing a gradient elastic modulus motion protective dental brace as described in any one of claims 1 to 5, characterized in that, Includes the following steps: S1. Oral cavity 3D data acquisition and working model construction: Three-dimensional raw data of the user's jawbone and dentition are obtained by cone-beam computed tomography and oral scanner. The three-dimensional raw data is then imported into reverse engineering software for data noise reduction, smoothing and model reconstruction. This completes the screening, splicing and optimization of the integrated digital working model of the jawbone and dentition, ensuring that the integrated digital working model of the jawbone and dentition is accurately matched with the user's oral physiological structure. S2, Basic Parameter Preset: Based on the user's oral health status and the impact intensity level of the target movement type, determine the maximum elastic modulus threshold of the bonding layer (3), and set the overall thickness range of the sports brace body. S3. Initial Model Establishment and Impact Simulation Analysis: Based on the integrated digital working model of the jawbone-dental arch constructed in step S1, and combined with the basic parameters preset in step S2, a preliminary three-dimensional structural model of the motion protection brace containing an impact-resistant layer (1), a buffer layer (2), and a bonding layer (3) is established using three-dimensional modeling software. The three-dimensional structural model of the preliminary motion protection brace and the integrated digital working model of the jawbone and dentition are imported into the finite element simulation software. An impact load matching the target motion scene is applied to simulate the impact process in actual motion and obtain the deformation, stress distribution cloud map and peak force data of the teeth in the integrated digital working model of the jawbone and dentition. S4. Gradient parameter optimization and optimal solution selection: Based on the simulation results of step S3, the design parameters of each layer in the three-dimensional structural model of the initial motion protection brace, including the thickness ratio of the impact-resistant layer (1), the buffer layer (2), and the bonding layer (3), the difference in elastic modulus between adjacent layers, or the rate of change of continuous elastic modulus, are adjusted and compared to select the optimal parameter combination. S5, Shaping: Based on the optimal parameter combination obtained from step S4, the thickness and elastic modulus of each layer are determined, and the motion protective brace is formed.

7. The preparation method according to claim 6, characterized in that, In step S5, the molding process is selected from any one of the following: co-extrusion molding, hot-pressing laminated composite process, or additive manufacturing process.

8. The preparation method according to claim 6, characterized in that, In step S5, the material of each layer in the sports protective brace is selected from any one or more combinations of ethylene-vinyl acetate copolymer (EVA), thermoplastic polyurethane elastomer (TPU), polyolefin elastomer (POE), and medical-grade rubber.

9. The application of a gradient elastic modulus motion protective brace as described in any one of claims 1 to 5 in motion scenarios where there is a risk of oral impact.

10. The application according to claim 9, characterized in that, Sports that pose a risk of oral impact include boxing, basketball, and rugby.

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