Lip-cheek side retention subperiosteal implant stent and manufacturing method thereof

Abstract

The invention discloses a lip-cheek side retention subperiosteal implant support and a manufacturing method, the implant support comprises a lip-cheek side connecting plate, one side of the lip-cheek side connecting plate is provided with a screw hole, a screw fixed on the lip-cheek side is arranged in the screw hole, the other side of the lip-cheek side connecting plate is of a hook structure, and the other side of the lip-cheek side connecting plate is of a hook structure. A plurality of implant bases are arranged at the convex position of the hook structure; the lip-buccal side connecting plate reconstructs a complete jaw bone structure of a patient through scanning data, the lip-buccal side bone surface contour is extracted, a basic support model is obtained after the contour line of the lip-buccal side connecting plate is designed in a three-dimensional model, then through three-dimensional finite element analysis, the layout of the implant abutment is optimized in combination with a stress distribution result and a screw hole site of the lip-buccal side, and the implant abutment is constructed. And then manufacturing the implant stent through 3D printing by adopting a topological optimization method. While the rigidity and durability are guaranteed, the overall structure is lighter, the number of used screws is smaller, the service life of the support is remarkably prolonged, and the risk of pressure damage is reduced.

Description

Technical Field

[0001] The present invention relates to a lip and buccal retention subperiosteal implant bracket and a manufacturing method, and in particular to a lip and buccal retention subperiosteal implant bracket and a manufacturing method based on three-dimensional finite element analysis and 3D printing, belonging to the field of oral implantology and medical device design. Background Art

[0002] In traditional implant design, patients are often required to have a certain amount of bone to achieve stable retention of the implant in the jaw. However, conventional implants are not suitable for patients with insufficient bone volume, extensive maxillary bone resorption, advanced age, or systemic diseases who are not suitable for bone grafting surgery. Subperiosteal implants are located on the subperiosteal surface rather than implanted in the bone, so they can achieve functional restoration without the need for bone grafting. Subperiosteal implants have greatly improved the patient experience, shortened the treatment cycle, and provided an important treatment option for patients who cannot accept traditional implants. At the same time, it has promoted the innovation and development of oral implant technology. As an area in the maxillary bone with relatively complete anatomical structure and good bone quality, the lip / buccal side has good mechanical support capabilities and surgical convenience, providing an ideal retention platform for subperiosteal implants.

[0003] Current subperiosteal implants suffer from insufficient bone mass, eccentric loading, or rotational instability, leading to poor adaptability, insufficient retention, and postoperative complications. Furthermore, the occlusal forces at different locations vary, requiring implants to be designed to accommodate these forces. Accurately simulating the stress distribution of implants under varying occlusal forces during the design phase, as well as precisely assessing the stress conditions in the contact area between subperiosteal implants, bone surfaces, and soft tissue, remain current challenges. Summary of the Invention

[0004] The technical problem to be solved by the present invention is: how to make the stress distribution of the oral implant bracket uniform during use and avoid the problems of unbalanced loading or rotational instability.

[0005] In order to solve the above technical problems, the technical solution of the present invention is to provide a labial and buccal retention subperiosteal implant bracket, which is characterized by comprising a labial and buccal connecting plate, a screw hole being provided on one side of the labial and buccal connecting plate, a screw being provided in the screw hole to be fixed to the labial and buccal side, and a hook structure being provided on the other side of the labial and buccal connecting plate, and a plurality of implant bases being provided at the raised position of the hook structure;

[0006] The labial and buccal connecting plate reconstructs the patient's complete jaw structure through scanning data, extracts the labial and buccal bone surface contours, designs the contour lines of the labial and buccal connecting plate in the three-dimensional model, and obtains the basic bracket model. Then, through three-dimensional finite element analysis, the layout of the implant base is combined with the stress distribution results and the screw hole positions on the labial and buccal sides to optimize. Then, the topological optimization method is used to obtain the optimal implant bracket shape, and the implant bracket is manufactured by 3D printing.

[0007] Preferably, the lip and cheek connecting plate is a fitting structure designed according to the residual bone surface morphology of the patient's lip and cheek, and one edge of the lip and cheek connecting plate is provided with multiple screw holes for easy fixation to the lip and cheek bone surface; the other side of the lip and cheek connecting plate is bent at the palate side.

[0008] Preferably, the labial and buccal side connecting plate is an integrally formed structure, and the labial and buccal side connecting plate includes a first link and a fifth link, and the first link and the fifth link are connected by a third link, a fourth link and a sixth link, two ends of the third link are respectively connected to one end of the first link and one end of the fifth link, the fourth link is located between the third link and the sixth link, the sixth link is connected to the other end of the first link near the end position and the other end of the fifth link near the end position, the other end of the first link and the other end of the fifth link are respectively provided with a plurality of screw holes arranged in sequence along their length directions, the middle position of the third link and the fourth link is connected by the second link, the positions between the third link and the fourth link on the first link and the fifth link are respectively bent, the middle position on the second link is also bent, and an implant base is provided on all bends.

[0009] Preferably, the steps of obtaining the basic scaffold model are as follows:

[0010] Based on the CBCT scanning data, the patient's complete jaw structure was reconstructed, the labial and buccal bone contours were extracted, and the labial and buccal connecting plate contours were designed in the 3D model, laying the foundation for the design of the labial and buccal connecting plate. Taking into account the anatomical characteristics and restoration needs, the distribution structure of the labial and buccal connecting plate and multiple implant abutments was designed, and the screw hole positions on the labial and buccal sides were rationally planned to achieve balanced retention and stable support for the implants, thereby obtaining a model structure of the basic bracket that fits the human maxillary bone.

[0011] Preferably, the three-dimensional finite element analysis is as follows: applying multi-directional simulated bite loads, analyzing stress concentration in different areas, optimizing the plate thickness and connection form according to the force line direction, and ensuring uniform force. The specific steps are as follows:

[0012] Step 1: Import the model structure of the basic bracket into the finite element platform to obtain the oral implant bracket model; perform finite element meshing on the oral implant bracket model;

[0013] Step 2: Perform physical field modeling on the oral implant bracket model and assign material properties to the implant and maxillary bone;

[0014] Step 3: Obtain the pressure exerted on the oral implant bracket during chewing in the oral cavity;

[0015] Step 4: Determine the boundary conditions and loads of the system: Since the upper surface of the human maxillary bone is completely fixed, the vertical load is directly applied to the oral implant bracket.

[0016] Step 5: Analyze the simulation results: including pressure distribution, Mises stress distribution and displacement distribution.

[0017] Preferably, in step 1, when dividing the finite element mesh, small mesh units are used in the contact area between the screw and the human maxillary bone and the oral implant bracket on the oral implant bracket model, and large mesh units are used in the remaining areas on the oral implant bracket model, so as to achieve a balance between accuracy and computational efficiency.

[0018] Preferably, the topology optimization method is used to obtain the optimal implant support shape with the goal of minimizing and maximizing Mises stress; the specific method is:

[0019] S31, initializing design variables;

[0020] S32, establishing an objective function, wherein the objective function is to minimize the maximum Mises stress of the oral implant bracket;

[0021] S33. Use numerical methods to calculate the sensitivity of objective functions and constraints to design variables;

[0022] S34, updating the design variables according to the sensitivity;

[0023] S35. updating the material properties of the finite element model according to the updated design variables;

[0024] S36. Determine the stopping condition and check whether the current number of iterations or volume fraction meets the stopping condition; if so, stop the iteration and output the current optimal design variable distribution, that is, the optimal implant shape; otherwise, return to step S33 and continue iteration.

[0025] Preferably, in step S31, the design variable is the unit density, which represents the relative content of the material in each finite element unit; in step S35, the SIMP interpolation model is used to associate the unit density with the material elastic modulus, and the updated finite element model is solved to calculate the design response of the stress and displacement of the implant.

[0026] Preferably, the surface of the buccal and labial connecting plates on the side in contact with the bone surface is a rough mesh structure; the surface of the buccal and labial connecting plates on the side in contact with the soft tissue is a highly polished structure.

[0027] A method for manufacturing a labial and buccal subperiosteal implant scaffold, characterized by comprising the following steps:

[0028] Step 1: 3D reconstruction and structural sketch design

[0029] The patient's complete jaw structure was reconstructed based on CBCT scan data, the labial and buccal bone contours were extracted, and the labial and buccal connection plate contours were designed in the 3D model, laying the foundation for the design of the labial and buccal connection plate.

[0030] Step 2: Implant layout and connection structure construction

[0031] Based on the anatomical characteristics and restoration requirements, the distribution structure of the labial and buccal connection plates and multiple implant abutments was designed, and the screw hole positions on the labial and buccal sides were rationally planned to achieve balanced retention and stable support for the implants, resulting in a model structure of the base frame that fits the human maxillary bone.

[0032] Step 3: 3D finite element analysis and topology optimization

[0033] The model structure of the foundation bracket was imported into the finite element platform, and multi-directional simulated bite loads were applied to analyze the stress concentration in different areas. The plate thickness and connection form were optimized according to the force line direction to ensure uniform force distribution and high overall safety.

[0034] Step 4: Printing and Precision Machining

[0035] After completing the optimized design of the oral implant bracket, the oral implant bracket is prepared through 3D printing technology. High-performance titanium alloy materials are selected, and the bracket is manufactured using SLM or EBM metal 3D printing technology. After printing is completed, CNC precision machining technology is used to trim the key connection surfaces to improve the structural fit and stability.

[0036] Compared with the prior art, the present invention has the following beneficial effects:

[0037] Subperiosteal implant designs based on 3D finite element analysis demonstrate superior mechanical optimization and structural adaptability compared to traditional approaches. Through digital modeling and occlusal mechanics simulation, the stress distribution of the implant under varying occlusal forces can be accurately simulated during the design phase, allowing targeted optimization of critical stress-bearing areas and effectively improving the mechanical stability and long-term lifespan of the restoration. Finite element analysis also accurately assesses the stress conditions in the subperiosteal implant's contact areas with the bone surface and soft tissue, providing a scientific basis for the implant's biomechanical performance. Modeling based on patient CT data, combined with finite element analysis optimization, and then directly 3D printing allows the implant's morphology to closely match the individual's bone anatomy, avoiding the large errors and poor fit associated with traditional manual shaping. This technology not only simulates the fatigue performance of the implant over long-term use and predicts potential mechanical risks, but also effectively reduces the incidence of localized mechanical stress concentrations and biocompatibility issues. The overall design better meets the individual patient's needs, significantly improving postoperative comfort and clinical success rates. This type of technology-driven innovation provides solid support for the development of subperiosteal implants, demonstrating enhanced performance advantages and broad clinical application prospects.

[0038] The present invention can realize customized design of oral implant brackets, construct a three-dimensional model of the oral implant bracket based on the obtained human maxillary model, use finite element simulation technology to simulate the implant, obtain the Mises stress distribution, and then based on the topology optimization method, with the purpose of reducing the maximum Mises stress, make the Mises stress distribution more uniform. While ensuring rigidity and durability, the overall structure is lighter and uses fewer screws, which can better adapt to the patient's oral physiological condition, thereby reducing the pressure on the patient when wearing it, significantly improving the service life of the bracket, and reducing the risk of pressure damage. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 Schematic diagram of a labial and buccal-retained subperiosteal implant scaffold;

[0040] Figure 2 Schematic diagram of finite element meshing for the human maxillary model;

[0041] Figure 3 Comparison diagram of Mises stress before and after stent optimization; (a) is the Mises stress diagram before stent optimization; (b) is the Mises stress diagram after stent optimization;

[0042] Figure 4 Schematic diagram of the installation and use of a labial and buccal retention subperiosteal implant bracket.

[0043] Among them, 1 is the labial and buccal connecting plate; 2 is the implant base; 3 is the screw;

[0044] 11 is the first connecting rod; 12 is the second connecting rod; 13 is the third connecting rod; 14 is the fourth connecting rod; 15 is the screw hole; 16 is the fifth connecting rod; and 17 is the sixth connecting rod. DETAILED DESCRIPTION

[0045] To make the present invention more clearly understood, preferred embodiments are described in detail below with reference to the accompanying drawings.

[0046] The present invention provides a labial and buccal subperiosteal implant support based on three-dimensional finite element analysis and 3D printing technology. Figure 1 As shown, it includes a labial and buccal connecting plate 1, one side of which is provided with a screw hole 15, in which a screw 3 fixed to the labial and buccal side is provided, and the other side of the labial and buccal connecting plate 1 is a hook structure, and a plurality of implant bases 2 are provided at the raised position of the hook structure;

[0047] The labial and buccal connecting plate reconstructs the patient's complete jaw structure through scanning data, extracts the labial and buccal bone surface contours, designs the contour lines of the labial and buccal connecting plate 1 in the three-dimensional model, and obtains the basic bracket model. Then, through three-dimensional finite element analysis, the layout of the implant base 2 is optimized in combination with the stress distribution results and the screw hole positions on the labial and buccal sides. Then, the topological optimization method is used to obtain the optimal implant bracket shape, and the implant bracket is manufactured by 3D printing.

[0048] The lip and cheek connecting plate 1 is a fitting structure designed according to the residual bone surface morphology of the patient's lip and cheek. One edge of the lip and cheek connecting plate 1 is provided with multiple screw holes 15 for easy fixation to the lip and cheek bone surface; the other side of the lip and cheek connecting plate 1 is bent at the palate side.

[0049] The labial and buccal connecting plate 1 is an integrally formed structure. The labial and buccal connecting plate 1 includes a first link 11 and a fifth link 16. The first link 11 and the fifth link 16 are connected by a third link 13, a fourth link 14, and a sixth link 17. The two ends of the third link 13 are respectively connected to one end of the first link 11 and one end of the fifth link 16. The fourth link 14 is located between the third link 13 and the sixth link 17. The sixth link 17 is connected to the other end of the first link 11 near the end position and the other end of the fifth link 16 near the end position. The other end of the first link 11 and the other end of the fifth link 16 are respectively provided with a plurality of screw holes 15 arranged in sequence along their length directions. The middle position of the third link 13 and the fourth link 14 is connected by the second link 12. The positions between the third link 13 and the fourth link 14 on the first link 11 and the fifth link 16 are respectively bent, and the middle position on the second link 12 is also bent, and an implant base 2 is provided on all bends.

[0050] The labial and buccal connecting plate 1 reconstructs the patient's complete three-dimensional jaw structure through CBCT scanning data, extracts the labial and buccal bone surface contours, designs the labial and buccal connecting plate 1 contour line in the three-dimensional model, and obtains the basic bracket model. Then, the occlusal force and multi-directional stress distribution are simulated through three-dimensional finite element analysis. The structure of the labial and buccal connecting plate 1, the layout of the implant base 2, combined with the stress distribution results and the screw hole position on the labial side are optimized to achieve the best match in terms of mechanical properties, bone surface fit and postoperative stability. Then, the topological optimization method is used to obtain the optimal implant bracket shape, and the implant bracket is manufactured by 3D printing.

[0051] The labial and buccal connecting plate 1 is designed to fit the patient's labial and buccal residual bone surface morphology. Multiple screw holes are provided on the edge of the bracket to facilitate intraoperative fixation to the labial and buccal bone surface. The labial and buccal bracket (i.e., the labial and buccal connecting plate) is inserted 0.5–1 mm into the bone to enhance initial stability and facilitate new bone wrapping.

[0052] Implant Abutments 2: Several implant abutments 2 are placed at the bend of the labial and buccal connecting plate 1. They penetrate the soft tissue and emerge into the oral cavity for connection to the upper restoration. The layout of the implant abutments 2 is optimized based on stress distribution results to ensure balanced force on each abutment under occlusal load and avoid stress concentration.

[0053] Surface treatment: The bone surface of the connection plate is roughened (sandblasting / acid etching, etc.) to promote bone integration. The soft tissue contact surfaces on the labial / buccal side and alveolar crest are highly polished to reduce the risk of soft tissue exposure.

[0054] The lip and cheek connecting plate 1 is located on the bone contact side and has a rough mesh structure on its surface, which is beneficial to bone integration and long-term stability; the lip and cheek connecting plate 1 is located on the soft tissue contact side and is highly polished to reduce the risk of soft tissue irritation and exposure.

[0055] Personalized Design: Bone morphology analysis and 3D modeling are performed based on the patient's CBCT data to achieve personalized implant design. Finite element analysis is used to optimize the labial / buccal-retained subperiosteal implant structure, and high-performance printing materials are selected for 3D printing. The labial / buccal framework extends 0.5–1 mm into the bone tissue, and the alveolar crest extends 1–2 mm below the bone. This enhances initial implant stability, promotes new bone wrapping around the framework, and reduces the risk of soft tissue exposure and associated complications.

[0056] A specific optimized manufacturing method for a labial and buccal retention subperiosteal implant scaffold is as follows:

[0057] Step 1: 3D reconstruction and structural sketch design

[0058] The patient's complete jaw structure was reconstructed based on CBCT scan data, the labial and buccal bone contours were extracted, and the outline of the labial and buccal connecting plate 1 was designed in the 3D model, laying the foundation for the design of the labial and buccal connecting plate 1.

[0059] Step 2: Implant layout and connection structure construction

[0060] Based on the anatomical characteristics and restoration requirements, the distribution structure of the labial and buccal connecting plate 1 and multiple implant abutments 2 was designed, and the positions of the screw holes 15 on the labial side were rationally planned to achieve balanced retention and stable support for the implants, thereby obtaining a model structure of the basic support that fits the human maxillary bone.

[0061] Step 3: Finite element simulation (3D finite element analysis optimization) and structural parameter optimization (using topology optimization method)

[0062] The model structure of the foundation bracket is imported into the finite element platform, and multi-directional simulated bite loads are applied to analyze the stress concentration in different areas. The plate thickness and connection form are optimized according to the direction of the force line to ensure uniform force and high overall safety.

[0063] Three-dimensional finite element analysis uses finite element simulation technology to simulate the oral implant bracket, simulate and analyze the constructed oral implant bracket model, and obtain its Mises stress distribution. The specific steps are as follows:

[0064] S21. Import the model structure of the basic bracket into the finite element platform to obtain the oral implant bracket model; the three-dimensional model of the oral implant bracket can be created using a computer-aided design tool (nTop, New York, USA). Perform finite element meshing on the oral implant bracket model: the smaller the unit of the finite element mesh, the higher the accuracy of the calculation, but the greater the amount of calculation. In order to strike a balance between accuracy and computational efficiency, smaller mesh units can be used in the contact area between the screw and the human maxillary bone and bracket as needed. The schematic diagram of finite element meshing is shown in the figure below. Figure 2 As shown;

[0065] S22. Perform physical field modeling on the oral implant scaffold model: assign material properties to the implant and maxillary bone; the material properties of the oral implant scaffold need to consider its mechanical properties, such as elastic modulus and Poisson's ratio; the material properties of the human maxillary bone model refer to the mechanical properties of human cortical bone.

[0066] S23. Obtain the pressure exerted on the oral implant bracket during chewing in the mouth by reviewing literature and conducting clinical research.

[0067] S24. Determine the boundary conditions and loads of the system: the upper surface of the human maxillary bone is completely fixed, and a vertical load is directly applied to the oral implant bracket model.

[0068] S25. Analyze simulation results: including pressure distribution, Mises stress distribution and displacement distribution.

[0069] The calculation formula of Mises stress is:

[0070]

[0071] Among them, σ1, σ2, and σ3 are three principal stresses. The principal stresses of each unit are calculated by finite element method, and then the Mises stress of each unit is obtained as the basic data of the design response.

[0072] The above simulation process using finite element analysis (FEA) is performed by using specialized finite element analysis software Abaqus.

[0073] S3. Use topology optimization to minimize the maximum Mises stress (Mises stress is a yield criterion, and its value is usually called equivalent stress) to obtain the optimal implant scaffold shape. The specific method is as follows:

[0074] S31, initializing design variables. In this embodiment, the design variable is unit density;

[0075] Element density is a core design variable that represents the relative amount of material in each finite element. Its value range is usually from 0 (no material) to 1 (solid material). In this example, the density of all elements in the design domain is initially set to 0.5 (indicating medium density).

[0076] S32. Establish an objective function. The objective function is typically to minimize or maximize a scalar quantity extracted from the design response. In this embodiment, the objective function is to minimize the maximum Mises stress of the implant.

[0077] The objective function can be expressed as

[0078] J=min(max(σ vM,i ))

[0079] Among them, J is the objective function, σ vM,i represents the Mises stress of the i-th unit, max(σ vM,i ) represents the maximum value of the Mises stress of all elements, and the optimization process aims to make this maximum value as small as possible by changing the design variables.

[0080] S33. Calculate sensitivity: Use numerical methods to calculate the sensitivity of the objective function and constraints to the design variables;

[0081] Sensitivity analysis is to calculate the derivatives of the objective function and constraints with respect to the unit density, which is used to guide the updating direction of the design variables. The calculation formula of the objective function sensitivity is:

[0082]

[0083] in, represents the sensitivity of Mises stress to element density, x_i represents element density, represents the principal stress components (j = 1, 2, 3);

[0084] S34: Update the design variables according to the sensitivity calculated in step S33. This is achieved through the optimization criterion method. The specific formula of the optimization criterion method is:

[0085]

[0086] in, represents the density of unit i at the k+1th iteration, c i represents the sensitivity of the objective function to the density of unit i, λ represents the Lagrange multiplier, m represents the maximum change in each iteration, x min and x max Indicates the lower and upper limits of density, usually 0.001 and 1;

[0087] S35. Update the material properties of the finite element model based on the updated cell density value. Use the SIMP (Solid Isotropic Material with Penalization) interpolation model to relate the cell density to the material elastic modulus, solve the updated finite element model, and calculate the design response of the implant, such as stress and displacement;

[0088] The SIMP interpolation formula is as follows:

[0089]

[0090] Among them, E0 is the elastic modulus of the solid material, E min is the elastic modulus of the cavity area (usually a very small value, such as E min =10 -9 E0), p is a penalty factor (generally p≥3), which is used to penalize the intermediate density units and promote the design to develop towards 0-1 discretization.

[0091] S36: Determine the stopping condition and check whether the current number of iterations or volume fraction meets the stopping condition. If so, stop the iteration and output the current optimal cell density distribution, i.e., the optimal implant shape. Otherwise, return to step S33 and continue the iteration.

[0092] The stopping condition can be expressed as

[0093]

[0094] Among them, V current is the implant volume of the current iteration step, V initial is the volume of the initial implant, f is the designed volume fraction, n is the current iteration number, N max is the maximum number of iterations, and ∨ represents a logical OR operation.

[0095] With material design strength as the goal, geometric models of implants with varying dimensions (e.g., implant thickness, typically the thickness of the rod near the implant abutment 2) and configurations (changing the internal structure while the implant outline is fixed) are established. Finite element analysis is then used to determine the size range and different structural configurations that meet the material design strength target. Alternatively, if the implant outline and internal structure are fixed, only geometric parameters such as thickness need to be varied when performing multiple finite element analyses.

[0096] Step 4: Printing and Precision Machining

[0097] After completing the optimized design of the oral implant bracket, the oral implant bracket can be prepared through 3D printing technology. High-performance titanium alloy materials are selected, and the bracket is manufactured using SLM or EBM metal 3D printing technology. After printing is completed, CNC precision machining technology is used to trim the key connection surfaces to improve the structural fit and stability.

[0098] The specific steps are as follows:

[0099] Generate 3D printing files: First, export the optimized oral implant framework design from the finite element simulation software and convert it into the STL file format suitable for 3D printing.

[0100] Prepare a 3D printer: Based on the design requirements and usage characteristics of the oral implant scaffold, select an appropriate 3D printer and choose the appropriate printing material. Since the oral implant scaffold needs to be implanted in the human oral environment, the material must be safe, non-toxic, comfortable, and possess sufficient strength and elasticity. Possible materials include plastics (such as PLA and ABS), elastomers (such as TPU), or specialized biomedical 3D printing materials.

[0101] Set 3D printing parameters: Based on the performance of the selected 3D printer and the characteristics of the printing material, reasonably set the 3D printing parameters, mainly including but not limited to parameters such as printing speed, layer thickness, filling density, printing temperature, etc., to ensure printing quality.

[0102] Start 3D printing: Load the generated 3D print file into the 3D printer and start the printing process after confirming that it is correct. During the printing process, the 3D printer will add printing material layer by layer according to the design of the 3D model, and finally form a three-dimensional oral implant framework.

[0103] Post-processing: After printing, a series of post-processing operations may be required to ensure the safety and comfort of the oral implant scaffold. These include removing support structures used during printing, smoothing the surface, and performing rigorous disinfection. Surface treatment includes roughening (sandblasting, acid etching, etc.) the bone-contacting surface of the scaffold to promote osseointegration. The soft-tissue contacting surface of the scaffold is highly polished to reduce the risk of soft-tissue exposure.

[0104] Step 5: Surgical operation and lip and cheek fixation

[0105] Complete the sterilization and adaptation evaluation of the stent before the operation; during the operation, open the flap from the lip and cheek side and implant the stent into the jaw surface according to the designed position, such as Figure 4 As shown, multiple screws were used to simultaneously fix the labial and buccal sides, and then the wound was sutured.

[0106] Step 6: Restoration Phase Management and Long-term Follow-up

[0107] After surgery, a temporary restoration is placed to maintain function and morphology. After bone integration is complete (approximately 4 to 6 months), a permanent restoration is installed, and regular follow-up is performed to ensure the restoration effect and long-term stability of the implant.

[0108] The invention has achieved a breakthrough in optimizing 3D-printed stents. Using a 70% volume fraction as the core constraint, the invention's implementation method successfully achieved a significant improvement in stent performance.

[0109] Before the adoption of this invention, the maximum stress the stent could withstand under the same working conditions was 1,410 MPa, which severely impacted the stent's service life and brought potential risks to clinical applications. However, after the adoption of this invention, the maximum stress was significantly reduced to 427 MPa, a decrease of 69.7%. Figure 3 As shown, it is far lower than the tensile strength of titanium alloy.

[0110] The stent of the present invention has achieved a qualitative leap in mechanical properties while maintaining the original load-bearing capacity, which not only greatly enhances the structural stability and durability of the stent, but also provides more reliable protection for patient safety.

Claims

1. A labial and buccal subperiosteal implant support, characterized in that: The invention comprises a labial and buccal connecting plate (1), wherein a screw hole (15) is provided on one side of the labial and buccal connecting plate (1), a screw (3) fixed to the labial and buccal side is provided in the screw hole (15), and the other side of the labial and buccal connecting plate (1) is a hook structure, and a plurality of implant bases (2) are provided at the raised position of the hook structure; The labial and buccal connecting plate reconstructs the patient's complete jaw structure through scanning data, extracts the labial and buccal bone surface contours, designs the contour lines of the labial and buccal connecting plate (1) in the three-dimensional model, and obtains the basic bracket model. Then, through three-dimensional finite element analysis, the layout of the implant base (2) is combined with the stress distribution results and the screw hole positions on the labial and buccal sides to optimize. Then, the topological optimization method is used to obtain the optimal implant bracket shape, and the implant bracket is manufactured by 3D printing.

2. The labial and buccal subperiosteal implant support according to claim 1, characterized in that: The lip and cheek connecting plate (1) is a fitting structure designed according to the residual bone surface morphology of the patient's lip and cheek. A plurality of screw holes (15) are provided on one edge of the lip and cheek connecting plate (1) for easy fixation to the lip and cheek bone surface; the other side of the lip and cheek connecting plate (1) is bent at the palate side.

3. The labial and buccal subperiosteal implant support according to claim 1, characterized in that: The lip and cheek side connecting plate (1) is an integrally formed structure. The lip and cheek side connecting plate (1) includes a first connecting rod (11) and a fifth connecting rod (16). The first connecting rod (11) and the fifth connecting rod (16) are connected by a third connecting rod (13), a fourth connecting rod (14), and a sixth connecting rod (17). The two ends of the third connecting rod (13) are respectively connected to one end of the first connecting rod (11) and one end of the fifth connecting rod (16). The fourth connecting rod (14) is located between the third connecting rod (13) and the sixth connecting rod (17). The sixth connecting rod (17) is connected to the other end of the first connecting rod (11). Near the end position and the other end of the fifth connecting rod (16), a plurality of screw holes (15) are arranged in sequence along the length direction on the other end of the first connecting rod (11) and the other end of the fifth connecting rod (16). The middle position of the third connecting rod (13) and the fourth connecting rod (14) are connected through the second connecting rod (12). The positions between the third connecting rod (13) and the fourth connecting rod (14) on the first connecting rod (11) and the fifth connecting rod (16) are bent respectively. The middle position on the second connecting rod (12) is also bent, and a planting base (2) is provided on all the bends.

4. The labial and buccal subperiosteal implant support according to claim 1, characterized in that: The steps for obtaining the basic support model are as follows: The patient's complete jaw structure is reconstructed based on CBCT scanning data, the labial and buccal bone contours are extracted, and the labial and buccal connecting plate (1) contour lines are designed in the three-dimensional model, laying the foundation for the design of the labial and buccal connecting plate (1); The distribution structure of the labial and buccal connecting plate (1) and multiple implant bases (2) is designed based on the comprehensive anatomical characteristics and restoration requirements, and the positions of the screw holes (15) on the labial and buccal sides are rationally planned to achieve balanced retention and stable support of the implants, thereby obtaining a model structure of the base support that fits the human maxillary bone.

5. The labial and buccal subperiosteal implant support according to claim 1, characterized in that: The three-dimensional finite element analysis involves applying multi-directional simulated bite loads, analyzing stress concentration in different areas, and optimizing the plate thickness and connection configuration based on the force line direction to ensure uniform stress distribution. The specific steps are as follows: Step 1: Import the model structure of the basic bracket into the finite element platform to obtain the oral implant bracket model; perform finite element meshing on the oral implant bracket model; Step 2: Perform physical field modeling on the oral implant bracket model and assign material properties to the implant and maxillary bone; Step 3: Obtain the pressure exerted on the oral implant bracket during chewing in the oral cavity; Step 4: Determine the boundary conditions and loads of the system: Since the upper surface of the human maxillary bone is completely fixed, the vertical load is directly applied to the oral implant bracket. Step 5: Analyze the simulation results: including pressure distribution, Mises stress distribution and displacement distribution.

6. The labial and buccal subperiosteal implant support according to claim 5, characterized in that: In step 1, when dividing the finite element mesh, small mesh units are used in the contact area between the screw and the human maxillary bone and the oral implant bracket on the oral implant bracket model, and large mesh units are used in the remaining areas on the oral implant bracket model, so as to achieve a balance between accuracy and computational efficiency.

7. The labial and buccal subperiosteal implant support according to claim 1, characterized in that: The topology optimization method is used to obtain the optimal implant scaffold shape with the goal of minimizing and maximizing Mises stress; the specific method is as follows: S31, initializing design variables; S32, establishing an objective function, wherein the objective function is to minimize the maximum Mises stress of the oral implant bracket; S33. Use numerical methods to calculate the sensitivity of objective functions and constraints to design variables; S34, updating the design variables according to the sensitivity; S35. updating the material properties of the finite element model according to the updated design variables; S36. Determine the stopping condition and check whether the current number of iterations or volume fraction meets the stopping condition; if so, stop the iteration and output the current optimal design variable distribution, that is, the optimal implant shape; otherwise, return to step S33 and continue iteration.

8. The labial and buccal subperiosteal implant support according to claim 7, characterized in that: In step S31, the design variable is the unit density, which represents the relative content of the material in each finite element unit; in step S35, the SIMP interpolation model is used to associate the unit density with the material elastic modulus, and the updated finite element model is solved to calculate the design response of the stress and displacement of the implant.

9. The labial and buccal subperiosteal implant support according to claim 1, characterized in that: The surface of the lip and cheek connecting plate (1) on the bone contact side is a rough mesh structure; the surface of the lip and cheek connecting plate (1) on the soft tissue contact side is a highly polished structure.

10. A method for manufacturing a labial and buccal subperiosteal implant scaffold according to any one of claims 1 to 9, characterized in that: The following steps are involved: Step 1: 3D reconstruction and structural sketch design The patient's complete jaw structure is reconstructed based on CBCT scanning data, the labial and buccal bone contours are extracted, and the labial and buccal connecting plate (1) contour lines are designed in the three-dimensional model, laying the foundation for the design of the labial and buccal connecting plate (1); Step 2: Implant layout and connection structure construction The distribution structure of the labial and buccal connecting plate (1) and the multiple implant bases (2) is designed based on the comprehensive anatomical characteristics and the repair requirements, and the positions of the screw holes (15) on the labial and buccal sides are rationally planned to achieve balanced retention and stable support of the implants, thereby obtaining a model structure of the base support that fits the human maxillary bone; Step 3: 3D finite element analysis and topology optimization The model structure of the foundation bracket was imported into the finite element platform, and multi-directional simulated bite loads were applied to analyze the stress concentration in different areas. The plate thickness and connection form were optimized according to the force line direction to ensure uniform force distribution and high overall safety. Step 4: Printing and Precision Machining After completing the optimized design of the oral implant bracket, the oral implant bracket is prepared by 3D printing technology. High-performance titanium alloy materials are selected and the bracket is manufactured using SLM or EBM metal 3D printing technology; After printing is completed, CNC precision machining technology is used to trim key connection surfaces to improve structural fit and stability.

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