Oral titanium film manufacturing method for dental implant guided bone regeneration

Abstract

The invention provides a method for manufacturing an oral titanium film for dental implant guided bone regeneration, which comprises the following steps of: 1, performing three-dimensional reconstruction according to oral imaging data of a patient to obtain a three-dimensional model containing an alveolar bone defect area; 2, based on the obtained three-dimensional model, in combination with curvature characteristics of an alveolar bone defect area corresponding to the three-dimensional model, manufacturing a mold capable of performing constraint pressing on the titanium mesh plate; the manufactured mold comprises a male mold and a female mold matched with the male mold in shape, and a gap is formed between the male mold and the female mold. 3, pressing the titanium screen plate by adopting the manufactured mold to obtain a formed titanium film; and 4, the obtained formed titanium film is subjected to cutting and edge grinding, and the oral cavity titanium film is obtained. According to the method, the mode that the mold is manufactured firstly and then the titanium film is manufactured is adopted, the problem that an irregular shape or discomfort possibly generated when a titanium mesh is bent manually in a traditional mode is solved, the strength of the titanium film can be well guaranteed, and better supporting and stability are achieved.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a method for fabricating an oral titanium membrane for guiding bone regeneration in dental implant Background Art

[0002] Oral implant technology is currently a widely adopted method for treating tooth loss and has become the mainstream means of oral restoration. With the continuous development of implant technology, the success rate of implants has gradually increased, and more and more patients choose this method for tooth restoration. However, many patients experience alveolar bone loss after tooth loss, especially when the bone volume is insufficient, the implantation of implants may be restricted, which directly affects the restoration effect. Therefore, how to effectively restore the defective alveolar bone and provide stable bone support has become an important problem to be solved in the field of oral implant

[0003] Currently, there are various methods for treating alveolar bone defects, among which the common ones include bone grafting and guided bone regeneration (GBR). The GBR technique promotes bone tissue regeneration and prevents the invasion of soft tissues through the application of a barrier membrane. In the prior art, commonly used barrier membrane materials include absorbable collagen membranes and non-absorbable titanium meshes. Titanium meshes are widely used in bone regeneration treatment in oral implant restoration due to their strong mechanical properties and biocompatibility. Generally, titanium meshes need to be manually bent to fit the oral defect area of the patient to ensure bone regeneration support and provide sufficient support force for implant implantation. However, there are some problems with manually bending titanium meshes, mainly including cumbersome and time-consuming operations, and it is difficult to ensure that the titanium mesh completely fits the shape of the patient's oral defect area, resulting in the titanium mesh not providing a good support effect. In addition, during the manual bending process, sharp edges are likely to be generated on the edges of the titanium mesh, which not only increases the risk of soft tissue irritation but also may lead to postoperative complications, thus affecting the restoration effect.

[0004] Although titanium meshes have certain advantages in guiding bone regeneration, during the process of manually bending titanium meshes, there are problems with difficult-to-guarantee precision, especially in areas with complex oral defects. Manually fabricated titanium meshes often cannot accurately fit the defective area of the patient, and the edges of the titanium mesh may be sharp, which may then lead to postoperative wound rupture. Therefore, the key problem in the current technology lies in how to precisely customize the titanium mesh to perfectly fit the oral defect area of the patient and avoid generating sharp edges, thereby reducing postoperative complications. Summary of the Invention

[0005] This application provides a method for fabricating an oral titanium membrane for guiding bone regeneration in dental implant, aiming to solve the problems in the prior art such as low precision in manually bending titanium meshes, non-matching of the titanium mesh shape to the defective area, and the existence of sharp edges.

[0006] The present application provides a method for manufacturing an oral titanium membrane for guided bone regeneration in dental implantation, comprising the following steps: Step 1: Perform three-dimensional reconstruction based on the oral imaging data of the patient to obtain a three-dimensional model including the alveolar bone defect area; Step 2: Based on the obtained three-dimensional model, combined with the curvature characteristics of the alveolar bone defect area corresponding to the three-dimensional model, manufacture a mold capable of performing constrained pressing on the titanium mesh plate; the manufactured mold includes a male mold and a female mold adapted to the shape of the male mold, and a gap is set between the male mold and the female mold; Step 3: Use the manufactured mold to perform pressing operation on the titanium mesh plate to obtain a formed titanium membrane; Step 4: Cut and edge-polish the obtained formed titanium membrane to obtain an oral titanium membrane.

[0007] In an alternative embodiment, the following steps are further included: Step 5: Try on the polished formed titanium membrane on the printed oral model, and then perform cleaning and sterilization treatments for clinical use.

[0008] In an alternative embodiment, in Step 5, use 3D printing technology to print an oral model including the oral defect area corresponding to the patient, then try on the polished formed titanium membrane, perform matching verification with this oral model to confirm the adaptability, and perform cleaning and sterilization treatments on the formed titanium membrane with good matching verification.

[0009] In an alternative embodiment, in Step 1, the oral imaging data includes cone beam CT (CBCT) scan data, intraoral scan data, and facial scan data; when constructing the three-dimensional model, obtain the three-dimensional data of the patient's oral and maxillofacial region through cone beam CT combined with intraoral scan data and facial scan data, and use these data for three-dimensional reconstruction to generate a three-dimensional model corresponding to the oral defect area.

[0010] In an alternative embodiment, the gap between the male mold and the female mold is the thickness of the titanium mesh plate to be pressed, and the size of the gap is 0.1 mm to 0.5 mm.

[0011] In an alternative embodiment, in Step 3, the pressing operation is to place the titanium mesh plate between the male mold and the female mold and then apply pressure to the mold at room temperature. The pressing operation adopts a step-by-step pressure increasing method to enable the titanium mesh plate to undergo plastic deformation under the action of pressure to form a formed titanium membrane adapted to the patient's oral defect area, and the pressure application process of the mold is controlled by mechanical or hydraulic equipment.

[0012] In an alternative embodiment, in step 2, the male mold and the female mold are designed and fabricated based on the three-dimensional model obtained in step 1. The specific process includes: Step 2.1: For the three-dimensional model obtained through three-dimensional reconstruction, in combination with the specific dimensions, curvature characteristics of the patient's oral defect area, and the bone augmentation requirements expected by the attending physician, and considering the relative positions of the titanium mesh and adjacent teeth and nerves after simulated implantation, simulate the implantation of the titanium mesh on the three-dimensional model to conform to the morphological requirements of the expected bone augmentation area; Step 2.2: According to the data of the simulated implanted titanium mesh, perform digital design of the male mold and the female mold to be fabricated, so as to ensure that the designed mold can have a pressing contour adapted to the shape of the simulated implanted titanium mesh, thereby obtaining the processing data of the male mold and the female mold to be fabricated; Step 2.3: Fabricate the male mold and the female mold through CNC numerical control machining technology. After the mold machining is completed, perform surface polishing treatment on the male mold and the female mold; Step 2.4: According to the patient's oral data and the actual requirements of titanium membrane forming, finely adjust and trim the gap of the mold to obtain the required mold.

[0013] In an alternative embodiment, the material for making the mold is high-strength alloy steel, and the high-strength alloy steel used is selected from H13 die steel, SKD11 die steel, and D2 die steel.

[0014] In an alternative embodiment, in step 4, the trimming operation is to remove the redundant part of the formed titanium membrane by using a shearing tool. The trimming process is carried out along the pattern area of the titanium membrane to avoid damage to the surface structure of the titanium membrane; after trimming, use sandpaper or a grinding tool to grind the edge of the titanium membrane to ensure that the edge of the titanium membrane is smooth and has no sharp parts, thereby reducing the mechanical stimulation to the patient's soft tissue.

[0015] In an alternative embodiment, the thickness of the titanium mesh plate is 0.1 mm to 0.5 mm, and the material of the titanium mesh plate is titanium alloy or titanium metal.

[0016] Compared with the prior art, the present application has the following beneficial effects: 1. The present application provides a method for fabricating an oral titanium membrane for guiding bone regeneration in dental implantation. First, three-dimensional reconstruction is performed through the patient's oral imaging data to obtain a three-dimensional model including the alveolar bone defect area. This process can accurately reflect the detailed data of the patient's oral structure, especially the morphological characteristics of the alveolar bone defect area. In this way, the obtained three-dimensional model can be used as the basis for titanium membrane design and can provide important support for the mold required for titanium membrane fabrication, thereby ensuring that the titanium membrane can accurately fit the patient's oral defect area.

[0017] 2. This application adopts the method of first manufacturing the mold and then manufacturing the titanium film. The mold to be manufactured is based on the three-dimensional model obtained from the three-dimensional reconstruction and is manufactured by combining the curvature characteristics of the defect area. This method can ensure that the titanium mesh plate is constrained and pressed by the mold. And there is a gap set between the male mold and the female mold, which can not only facilitate the positioning and placement of the pre-pressed titanium mesh plate, but also facilitate better adaptation to the internal contour of the mold when the titanium mesh plate is pressed by the mold to generate a shape change that adapts to the shape of the titanium film to be manufactured, so as to realize the more precise pressing effect of the mold, avoiding the problems of irregular shapes or non-fitting that may occur in the traditional manual bending of titanium meshes. Moreover, by using this method of manufacturing the oral titanium film by mold pressing, the strength of the manufactured titanium film can be better guaranteed, thus having better support and stability, and more effectively promoting bone regeneration.

[0018] 3. This application adopts the method of pressing operation and combines with a precisely manufactured mold, which can make the titanium mesh plate undergo plastic deformation by applying uniform pressure to form a titanium film adapted to the oral defect area of the patient. This process can better ensure that the shape of the formed titanium film has an effective structure part of the titanium film that meets the individual needs, reducing the inaccurate or unsuitable shapes that may occur in manual bending. In addition, through the process of cutting and edge grinding of the formed titanium film, the edge of the titanium film can be further made smooth without sharp parts, thereby reducing postoperative complications and discomfort. These delicate designs and process treatments can improve the clinical applicability of the titanium film and enhance the comfort of the patient, thus ultimately improving the treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0020] Figure 1 It is a flowchart of a method for manufacturing an oral titanium film for guiding bone regeneration in dental implantation provided by an embodiment of the present application; Figure 2 It is a flowchart of a method for manufacturing an oral titanium film for guiding bone regeneration in dental implantation provided by another embodiment of the present application; Figure 3 It is a schematic diagram of the gap between the male mold and the female mold provided by an embodiment of the present application. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0021] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the following clearly and completely describes the technical solutions in the embodiments of this application. Obviously, the described embodiments are some, but not all, of the embodiments of this application. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in this application without creative efforts also belong to the scope of protection of this application.

[0022] Please refer to Figure 1 , the embodiments of this application provide a method for manufacturing an oral titanium membrane for guiding bone regeneration in dental implantation, including the following steps: Step S1: Perform three-dimensional reconstruction based on the oral imaging data of the patient to obtain a three-dimensional model including the alveolar bone defect area; Step S2: Based on the obtained three-dimensional model, in combination with the curvature characteristics of the alveolar bone defect area corresponding to the three-dimensional model, manufacture a mold capable of performing constrained pressing on the titanium mesh plate; the manufactured mold includes a male mold and a female mold adapted to the shape of the male mold, and a gap is set between the male mold and the female mold; Step S3: Use the manufactured mold to perform a pressing operation on the titanium mesh plate to obtain a formed titanium membrane; Step S4: Cut and polish the edges of the obtained formed titanium membrane to obtain an oral titanium membrane.

[0023] The method for manufacturing an oral titanium membrane for guiding bone regeneration in dental implantation provided by the embodiments of this application first performs three-dimensional reconstruction through the oral imaging data of the patient to obtain a three-dimensional model including the alveolar bone defect area. This process can accurately reflect the detailed data of the patient's oral structure, especially the morphological characteristics of the alveolar bone defect area. In this way, the three-dimensional model obtained by the embodiments of this application can be used as the basis for titanium membrane design and can provide important support for the molds required for titanium membrane manufacturing, thereby ensuring that the titanium membrane can accurately fit the oral defect area of the patient.

[0024] Meanwhile, the method for manufacturing an oral titanium membrane for guided bone regeneration in dental implantation according to the embodiments of the present application adopts a method of first manufacturing a mold and then manufacturing the titanium membrane. The mold to be manufactured is based on the three-dimensional model obtained by three-dimensional reconstruction and is manufactured in combination with the curvature characteristics of the defect area. Such a method can ensure that the titanium mesh plate is constrained and pressed by the mold. And a gap is set between the male mold and the female mold, which can not only facilitate the positioning and placement of the pre-pressed titanium mesh plate, but also facilitate better adaptation to the inner contour of the mold when the titanium mesh plate is pressed by the mold to generate a shape change suitable for the shape of the titanium membrane to be manufactured, so as to realize the more precise pressing effect of the mold, avoiding the problems of irregular shapes or non-matching that may occur in the traditional manual bending of titanium meshes. Moreover, by manufacturing the oral titanium membrane in this way of mold pressing, the strength of the manufactured titanium membrane can be better guaranteed, so as to have better support and stability, and thus more effectively promote bone regeneration.

[0025] In addition, the embodiments of the present application adopt a pressing operation method and, in combination with a precisely manufactured mold, can make the titanium mesh plate undergo plastic deformation by applying uniform pressure to form a titanium membrane adapted to the oral defect area of the patient. This process can better ensure that the shape of the formed titanium membrane has an effective structure part of the titanium membrane that meets individual needs, reducing the situation of inaccurate or unsuitable shapes that may occur in manual bending. In addition, through the process of cutting and edge grinding of the formed titanium membrane, the edge of the titanium membrane can be further made smooth without sharp parts, thereby reducing postoperative complications and discomfort. These meticulous designs and process treatments can improve the clinical applicability of the titanium membrane and enhance the comfort of the patient, thus ultimately improving the treatment effect.

[0026] As Figure 2 shown, in some embodiments, the following steps are further included: Step S5: Try on the polished formed titanium membrane on the printed oral model, and then perform cleaning and sterilization treatments for clinical use.

[0027] In the above embodiments, in step S5, the polished formed titanium membrane is tried on the printed oral model to facilitate matching verification with the printed oral model. This operation enables the formed titanium membrane to be verified before actual use, thus ensuring that it can accurately fit the oral structure of the patient. Moreover, through the trial fitting, it can be checked whether the titanium membrane matches the defect area of the patient's oral cavity, avoiding errors in the traditional manual manufacturing method, thereby reducing the problem of non-conformity between the titanium membrane and the defect area. This personalized matching verification is beneficial to ensuring a high degree of consistency between the manufactured titanium membrane and the actual application.

[0028] In addition, by cleaning and sterilizing the titanium membrane in step S5, the pollution source can be effectively eliminated, thus ensuring the hygienic safety of the titanium membrane in clinical use. Medical materials implanted in the patient's oral cavity must meet strict hygienic requirements. The cleaning and sterilization process can remove potential pathogenic bacteria and reduce the risk of postoperative infection. Such a process makes the use of the titanium membrane comply with medical device standards, improves the safety of the treatment process, and can also provide a more reassuring treatment experience for patients.

[0029] Moreover, through the trial fitting step, the fabricated titanium membrane is also provided with the opportunity for adjustment and optimization, enabling the titanium membrane to be adjusted and improved before actual use. Doctors can check the adaptability of the titanium membrane after trial fitting and make fine adjustments for minor problems with the titanium membrane. This process not only improves the clinical applicability of the titanium membrane but also enables personalized customization based on the patient's feedback, thus better meeting the patient's needs with the final treatment effect. And in this way, the adaptability of the titanium membrane can be further ensured, thereby effectively enhancing the treatment effect and patient satisfaction.

[0030] In some embodiments, in step S5, a 3D printing technique is used to print an oral model that includes the oral defect area corresponding to the patient, and then the polished formed titanium membrane is tried on and matched with the oral model for verification to confirm the adaptability, and the formed titanium membrane with good matching verification is cleaned and sterilized.

[0031] In the above embodiments, using the 3D printing technique to print the oral model can accurately reproduce the specific shape of the patient's oral defect area. Through this personalized printing technique, the structural accuracy of the oral model can be ensured, avoiding the possible errors in traditional methods. On this basis, the polished formed titanium membrane is tried on and matched with the printed oral model. This verification link can better ensure the precise adaptation of the titanium membrane to the patient's oral defect area, thus improving the personalized customization level of the oral titanium membrane. In this embodiment, by matching the 3D printed model with the titanium membrane, it is further confirmed whether the titanium membrane meets the oral structure requirements of the patient, avoiding the problem of non - adaptation and improving the repair effect.

[0032] Moreover, through trial fitting and matching verification with the 3D printed oral model, the adaptability of the titanium membrane can be fully confirmed before actual application. The addition of this verification link helps doctors to timely check whether the titanium membrane perfectly matches the patient's oral structure and make necessary adjustments. This is more accurate and scientific than simply relying on theoretical design or intuitive judgment of the titanium membrane's adaptability in traditional methods.

[0033] In some embodiments, in step S1, the oral imaging data includes cone beam computed tomography (CBCT) scan data, intraoral scan data, and facial scan data; when constructing the three-dimensional model, the three-dimensional data of the patient's oral and maxillofacial region is obtained by combining cone beam CT with intraoral scan data and facial scan data, and these data are used for three-dimensional reconstruction to generate a three-dimensional model corresponding to the oral defect region.

[0034] When performing three-dimensional reconstruction to generate the three-dimensional model, corresponding computer software for three-dimensional model design can be used. This technology belongs to the commonly used technology in the field of oral medicine, and its principle will not be described in detail here. Optionally, in this embodiment, the generation of the three-dimensional model uses Mimics and Freeform professional computer software. Mimics is a software commonly used for medical image processing, which can convert the patient's oral imaging data (such as cone beam CT (CBCT) scan data, intraoral scan data, and facial scan data) into a high-precision three-dimensional model. Mimics can achieve high-precision three-dimensional reconstruction by integrating and processing different types of image data, and then provide an accurate oral structure model, providing a reliable basis for subsequent titanium membrane design and mold production. Freeform is a tool focused on three-dimensional model design and virtual prototyping, commonly used in mold design and shape optimization. In the embodiment of the present application, the Freeform software can be used to combine the patient's three-dimensional data and the doctor's expected bone augmentation requirements, and further optimize the design by virtually simulating the implantation process of the titanium mesh, so as to ensure that the mold can accurately match the shape of the patient's oral defect region. By using these two software in combination, the efficient conversion from oral imaging data to three-dimensional model and the optimization design can be achieved, thus ensuring the accuracy and personalization of each step in the titanium membrane production process. By using the Mimics and Freeform software in cooperation, accurate three-dimensional reconstruction and design can be achieved, providing technical support for the personalized customization and high-quality production of the titanium membrane, and at the same time providing a solid foundation for the accuracy of the final repair effect and the comfort of the patient.

[0035] In step S1, the patient's oral imaging data relied on for three-dimensional reconstruction to obtain the three-dimensional model includes cone beam CT (CBCT) scan data, intraoral scan data, and facial scan data. In this embodiment, the cone beam CT (CBCT) scan data, intraoral scan data, and facial scan data are combined, so that the three-dimensional reconstruction is based on comprehensive imaging data. This multi-dimensional data fusion can more comprehensively and accurately reflect the morphological and structural characteristics of the patient's oral and maxillofacial region. Moreover, by performing three-dimensional reconstruction on these data, a high-precision three-dimensional model can be obtained. This three-dimensional model provides a detailed personalized basis for subsequent titanium membrane design and mold production, so as to ensure that the produced titanium membrane has good adaptability.

[0036] In addition, by combining CBCT scans, intraoral scans, and facial scan data, the obtained three-dimensional data is more objective and accurate, avoiding the errors caused by relying on traditional manual measurements or single imaging techniques. CBCT scans can precisely display the details of bone structures, while intraoral scans and facial scans can provide comprehensive information about the inside and outside of the oral cavity. Such a method can improve the three-dimensional reconstruction accuracy of the oral defect area, enabling the subsequent designed molds and titanium membranes to be customized according to the actual oral structure of the patient, reducing the shape mismatch problems that may occur during the manual processing, and thus improving the reliability of the repair effect.

[0037] In some embodiments, the gap between the male mold and the female mold is the thickness of the titanium mesh plate to be pressed, and the size of the gap is from 0.1 mm to 0.5 mm. In this embodiment, the gap range is limited to 0.1 mm to 0.5 mm, which can cover titanium mesh plates of different common thicknesses and meet different clinical needs. For example, for thinner titanium mesh plates, a smaller gap can be used to ensure the pressing effect; for thicker titanium mesh plates, a larger gap can be used to ensure that excessive pressure will not be generated during the pressing process, avoiding damage to the titanium mesh material. This enables the mold to achieve an ideal pressing effect in different situations and adapt to more clinical scenarios and patient needs.

[0038] As Figure 3 shown, this embodiment gives a schematic diagram of the gap between the male mold and the female mold. As Figure 3 shown, the male mold 100 is located above the female mold 200. A gap 300 is provided between the male mold 100 and the female mold 200. The gap 300 between the male mold 100 and the female mold 200 is the void between them when the male mold 100 contacts the female mold 200. The size of this gap 300 is the length of this void in the height direction. The gap 300 is set as a square structure to meet the placement requirements of the square-structured titanium mesh plate to be pressed. Moreover, the size specification of the surface of the gap 300 in contact with the titanium mesh plate is consistent with the surface size specification of the titanium mesh plate to be pressed. Below the male mold 100, there are protrusions that can exert pressure on the titanium mesh plate, and above the female mold 200, there are corresponding grooves. Around the upper edge of the female mold 200, there is a boss 210 with the same thickness as the titanium mesh plate to be pressed. The gap 300 is set above the female mold 200 and outside the upper part of the groove. The inner side of the boss forms this gap 300 between the male mold 100 and the female mold 200. When the male mold 100 and the female mold 200 are in full contact, the protrusions of the male mold 100 and the grooves of the female mold 200 form the pressing contour of the oral titanium membrane to be made. At the same time, this pressing contour is adapted to the shape of the titanium mesh for simulated implantation.

[0039] In the above embodiment, the gap between the male mold and the female mold is set to the thickness of the titanium mesh plate, and the size of the gap is designed to be 0.1 mm to 0.5 mm, that is, the length of this gap in the height direction. The details of this gap setting directly affect the forming accuracy of the titanium film.

[0040] The gap setting between the male mold and the female mold is crucial for the positioning and accurate pressing of the titanium mesh plate. When using the mold to press the titanium mesh plate, the titanium mesh plate needs to be accurately placed within the pressing area of the mold. The existence of the gap allows the titanium mesh plate to easily enter the mold during placement before pressing and maintain a fixed and uniform positioning before pressing. Moreover, the existence of this gap prevents the titanium mesh plate from deviating randomly during pressing. Without a reasonable gap, it is easy for the titanium mesh plate to deviate from the predetermined shape during the pressing process, affecting the adaptability of the formed titanium film. And since the size of this gap is the thickness of the titanium mesh plate, during the pressing process, especially in the final stage of the pressing process, it can better ensure that excessive extrusion deformation does not occur at both ends of the titanium mesh plate when the titanium mesh plate undergoes plastic deformation, thereby obtaining a better pressing effect and laying a foundation for the precise forming of the titanium film. During the pressing process, as the applied pressure gradually increases, the contact between the male mold and the female mold is gradually achieved. When the male mold and the female mold are in full contact, the set gap between the male mold and the female mold will play an important role. The existence of the gap allows the titanium mesh plate to uniformly contact the inner contour of the mold, enabling the titanium mesh plate to undergo uniform plastic deformation under the action of pressure. Due to the existence of the gap, the pressure of the mold on the titanium mesh plate can better act on the area that needs to be deformed. Without affecting the effective deformation of the titanium mesh plate, the transition positions at both ends of the titanium mesh plate in the gap and the effective part of the titanium mesh plate that serves as the titanium film can reduce the pressing effect, preventing excessive deformation at both ends of the part of the titanium mesh plate that serves as the titanium film and affecting the manufacturing accuracy of the titanium film, so as to better make the shape of the finally formed titanium film conform to the design requirements.

[0041] In addition to the positioning function, the gap can also play a buffering and adapting role during the pressing process of the titanium mesh plate. When the mold applies pressure, the titanium mesh plate will undergo uniform plastic deformation, and the existence of the gap allows the titanium mesh plate to fine-tune its shape in the later stage of the pressing process, enabling it to better adapt to the inner contour of the mold. Specifically, as the pressure gradually increases, the titanium mesh plate can deform according to the change of the mold contour, and this adaptability is smoother with the help of the gap. If the gap is too small, the titanium mesh plate will be subjected to excessive resistance, resulting in local over-pressing and even possible cracking or deformation. An appropriate gap can ensure that each position on the titanium mesh plate can better balance the force during the pressing process, achieving uniform plastic deformation, and thus forming a titanium film shape that conforms to the predetermined design requirements.

[0042] In addition, another important function of setting an appropriate gap is to help the mold achieve a more precise pressing effect. When the titanium mesh plate is under the pressure applied by the mold, it will directly affect the shape and size of the formed titanium film. As a key adjustment factor during the pressing process, the gap can make the pressure applied by the mold on the titanium mesh plate more uniform. If the gap is set improperly, the mold is likely to generate excessive or insufficient pressure in some parts, resulting in an asymmetric shape or local deformation of the titanium film. An appropriate gap can help the mold distribute the pressure evenly, enabling the titanium mesh plate to fully contact the inner contour of the mold throughout the pressing process, ensuring that the formed titanium film meets the expected geometric shape and structural requirements. This precise pressing effect can ultimately effectively improve the quality of the titanium film, thus better adapting to the oral defect area of the patient.

[0043] In some embodiments, in step S3, the pressing operation is performed by placing the titanium mesh plate between the male mold and the female mold and then applying pressure to the mold at room temperature. The pressing operation adopts a step-by-step pressure increasing method to cause the titanium mesh plate to undergo plastic deformation under the action of pressure, forming a formed titanium film adapted to the oral defect area of the patient. The pressure application process of the mold is controlled by mechanical or hydraulic equipment.

[0044] In the above embodiments, the pressing operation adopts a step-by-step pressure increasing method and is carried out at room temperature. This step-by-step pressure increasing method enables the titanium mesh plate to gradually adapt to the pressure change during the stress process, avoiding damage or uneven deformation to the titanium mesh plate. Step-by-step pressure increasing can better enable the titanium mesh plate to undergo plastic deformation evenly during the stress process, thereby obtaining a titanium film that conforms to the shape of the oral defect area of the patient. This method effectively avoids problems such as local over-pressing or irregular morphology, ensuring the accuracy and consistency of the formed titanium film.

[0045] At the same time, in this embodiment, a mechanical or hydraulic device is used to control the pressure application process, which can provide more precise pressure control during the operation. This method is more accurate than the traditional manual pressure application, and can ensure that the force applied to the mold is uniform, thereby avoiding the situation of uneven pressure or local overload. Whether it is mechanical control or hydraulic control, it can provide a more stable and controllable pressure, enabling the titanium mesh plate to undergo plastic deformation under precise pressure, further improving the morphological consistency and accuracy of the titanium film.

[0046] In addition, since the pressing operation is carried out at room temperature, it avoids the excessive thermal deformation of the titanium mesh material caused by high-temperature pressing, thus maintaining the strength and stability of the titanium mesh plate. Room-temperature pressing also means that the operation is simpler and does not require additional heating equipment, which reduces the complexity and potential risks of the operation. At the same time, the control of mechanical and hydraulic equipment makes the pressing process more automated and precise, improving production efficiency, reducing manual intervention, and further enhancing the stability and repeatability of the production process.

[0047] In some embodiments, in step S2, the male mold and the female mold are designed and fabricated based on the three-dimensional model obtained in step S1. The specific process includes: Step S2.1: With the three-dimensional model obtained through three-dimensional reconstruction, combined with the specific dimensions, curvature characteristics of the patient's oral defect area, and the bone augmentation requirements expected by the attending physician, and considering the relative positions of the titanium mesh with adjacent teeth and nerves after simulated implantation, simulate the implantation of the titanium mesh on the three-dimensional model to meet the morphological requirements of the expected bone augmentation area; Step S2.2: According to the data of the simulated implanted titanium mesh, perform digital design of the male mold and the female mold to be fabricated, so as to ensure that the designed mold can have a pressing contour adapted to the shape of the simulated implanted titanium mesh, thereby obtaining the processing data of the male mold and the female mold to be fabricated; Step S2.3: Fabricate the male mold and the female mold through CNC numerical control machining technology. After the mold machining is completed, perform surface polishing treatment on the male mold and the female mold; Step S2.4: According to the patient's oral data and the actual requirements of titanium membrane forming, finely adjust and trim the gap of the mold to obtain the required mold.

[0048] In the above embodiments, first, by combining the three-dimensional model, the specific dimensions, curvature characteristics of the patient's oral defect area, and the bone augmentation requirements expected by the attending physician, simulate the implantation of the titanium mesh. This process fully considers the patient's individual oral structure, bone augmentation needs, and the relative positions of adjacent teeth and nerves, so as to ensure that the effect of the titanium mesh after implantation can be accurately simulated during design. Through accurate simulation of implantation, a more reasonable mold design for titanium membrane fabrication can be achieved, enabling it to fully meet the morphological requirements of the expected bone augmentation area. This precise design process enables the fabricated titanium membrane to effectively support bone regeneration and match the anatomical structures in the oral environment, reducing the errors and mismatching problems that may occur in traditional manual design.

[0049] In step S2.2, according to the data of the titanium mesh after simulated implantation in this embodiment, digital design of the male die and female die to be fabricated is carried out. By digitally designing the male die and female die, based on the data of the titanium mesh after simulated implantation, the designs of the male die and female die can better meet the contour requirements of the titanium mesh. This method can not only improve the precision of die design, but also enable the die to have the pressing contour required for pressing the titanium film to be fabricated, so that the fabricated titanium film meets the design requirements, avoiding the problem of titanium film mismatch caused by design errors. At the same time, in this embodiment, digital tools are used for die design, which can achieve a high-precision pressing contour, further ensuring a good fit between the formed titanium film and the oral defect area of the patient, thus effectively improving the stability and consistency of the treatment effect.

[0050] In addition, in this embodiment, the male die and female die are fabricated by CNC numerical control machining technology, which can significantly improve the precision and efficiency of die machining. Using this precise machining technology of CNC numerical control machining can ensure the consistency of the die in shape and size with the designed requirements, avoiding errors that may occur in manual machining. At the same time, the automation and high-precision requirements of CNC technology can speed up the production speed, reduce manual intervention and operation errors, and improve the overall production efficiency. In addition, through surface polishing treatment, the smoothness and flawlessness of the die surface can be ensured, further improving the forming effect of the titanium film and the finished product quality.

[0051] In some embodiments, the material for fabricating the die is high-strength alloy steel, and the high-strength alloy steel used is selected from H13 die steel, SKD11 die steel, and D2 die steel.

[0052] The die is made of high-strength alloy steel, specifically one of the materials such as H13 die steel, SKD11 die steel, and D2 die steel. These high-strength alloy steel materials have excellent wear resistance, fatigue resistance, and high-temperature resistance, and can effectively cope with the pressure and high-frequency operations during the titanium mesh pressing process. By selecting these materials, the die can maintain its shape and function during long-term use, avoiding a decrease in precision caused by wear or fatigue, so that the titanium film maintains a relatively stable forming quality during the entire pressing process.

[0053] In addition, the high hardness characteristic of high-strength alloy steel makes the die not easily deformed during the pressing process, thus enabling higher forming precision. Using these alloy steel materials such as H13 die steel, SKD11 die steel, and D2 die steel can not only withstand a higher pressing force, but also ensure that the die can still maintain an accurate pressing contour after multiple uses, avoiding dimensional deviations caused by material wear. More precise die machining ensures that the shape and size of each pressed titanium film are highly consistent with the design standards, helping to improve production efficiency and reduce the generation of unqualified products.

[0054] In some embodiments, in step S4, the trimming operation is performed by using a shearing tool to remove the redundant part of the formed titanium film. The trimming process is carried out along the pattern area of the titanium film to avoid damage to the surface structure of the titanium film. After trimming, sandpaper or a grinding tool is used to polish the edge of the titanium film to ensure that the edge of the titanium film is smooth and has no sharp parts, thereby reducing the mechanical irritation to the patient's soft tissue.

[0055] The shearing tool is used to remove the redundant part of the formed titanium film. The trimming process is carried out along the pattern area of the titanium film, which avoids possible deformation or damage on the surface of the titanium film. Moreover, trimming the pattern area can keep the structure of the titanium film at its original strength and stability, and at the same time will not have an adverse effect on subsequent use. The step of polishing the edge of the trimmed titanium film is to solve the possible sharp parts on the edge of the titanium film. Using sandpaper or a grinding tool to polish the edge can effectively remove the acute angles on the edge of the titanium film and make it smooth and round, thereby reducing the mechanical irritation to the oral soft tissue of the patient. This operation can improve the comfort of the patient when using the titanium film and reduce complications such as pain or wound rupture caused by the sharp edge of the titanium film after surgery, thus ensuring the safety and comfort of the oral restoration process.

[0056] In addition, through precise trimming and edge polishing, the adaptability and comfort of the titanium film are optimized. The long-term stability and adaptability of the titanium film in the oral cavity will be guaranteed. The titanium film with a smooth edge and no sharp parts not only reduces the discomfort of the patient, but also can be more closely combined with the patient's oral tissues in the long term, preventing soft tissue inflammation or damage caused by improper stimulation of the titanium film. This optimization in detail improves the clinical application effect of the titanium film, enabling the patient to recover more smoothly after surgery and thus increasing the success rate of implant restoration treatment.

[0057] When trimming the titanium film, shearing pliers or cutting can be used for trimming. For the titanium mesh exceeding the edge, trimming is carried out. If the excess size is in the middle of the pattern, trimming is carried out at the complete pattern to avoid the generation of sharp edges after this part is trimmed, which may cause wound rupture after surgery during use.

[0058] In some embodiments, the thickness of the titanium mesh plate is 0.1 mm to 0.5 mm, and the material of the titanium mesh plate is titanium alloy or titanium metal.

[0059] The thickness range of the titanium mesh plate used is from 0.1 mm to 0.5 mm. This thickness range ensures that the titanium mesh plate has sufficient mechanical strength while not being overly thick and heavy, avoiding discomfort or excessive compression of oral tissues after implantation. The use of titanium alloy or titanium metal further improves the stability and durability of the titanium mesh plate. Titanium alloy has high corrosion resistance and biocompatibility, can stably combine with bone tissue for a long time, and reduces the risk of postoperative infection. Supported by these characteristics, the titanium mesh plate can provide a more reliable bone regeneration guiding effect for dental implantation.

[0060] At the same time, by selecting titanium alloy or titanium metal as the material of the titanium mesh plate, it can effectively ensure that the titanium membrane can withstand appropriate pressure during implantation without causing excessive irritation to oral soft tissues. The excellent properties of titanium alloy and titanium metal make the titanium membrane lighter and more flexible, helping it to better adapt to the alveolar bone structure of patients in the oral cavity. The thickness of the titanium mesh plate is controlled within the range of 0.1 mm to 0.5 mm, enabling the titanium membrane to provide sufficient support while maintaining high comfort. This design can effectively avoid the discomfort and oral irritation that may be brought by traditional thicker or rigid titanium membranes.

[0061] Moreover, titanium alloy and titanium metal, as materials with excellent biocompatibility, can reduce the body's rejection reaction to the titanium membrane. The good biocompatibility of the titanium membrane material enables it to better integrate with bone tissue, thereby promoting bone regeneration. This biocompatibility helps the stable combination of the titanium membrane with the patient's alveolar bone, further improving the reliability of the oral titanium membrane during long-term use. In this embodiment, through the material selection of the titanium mesh plate, the titanium membrane can provide more lasting and effective support during the process of guiding bone regeneration, ensure the sustainability of the bone augmentation effect, and ultimately improve the success rate and effect of dental implantation.

[0062] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present application, rather than to limit them; although the present application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application.

Claims

1. A method for preparing an oral titanium membrane for guided bone regeneration in dental implants, characterized in that: The following steps are involved: Step 1: Perform three-dimensional reconstruction based on the patient's oral imaging data to obtain a three-dimensional model including the alveolar bone defect area; Step 2: Based on the obtained three-dimensional model and the curvature characteristics of the alveolar bone defect area corresponding to the three-dimensional model, a mold capable of constraining the titanium mesh plate is manufactured; the manufactured mold includes a positive mold and a negative mold adapted to the shape of the positive mold, and a gap is set between the positive mold and the negative mold; Step 3, using the prepared mold to press the titanium mesh plate to obtain a formed titanium film; Step 4: cutting and edge grinding the obtained shaped titanium film to obtain an oral titanium film.

2. The method for preparing an oral titanium membrane for guided bone regeneration of dental implants according to claim 1, characterized in that: The following steps are also included: Step 5: Try the polished titanium film on the printed oral model, then clean and sterilize it for clinical use.

3. The method for preparing an oral titanium membrane for guided bone regeneration of dental implants according to claim 2, characterized in that: In step 5, a 3D printing technology is used to print an oral model containing the corresponding oral defect area of ​​the patient, and then the polished molded titanium membrane is tried on and matched with the oral model to confirm the adaptability, and the molded titanium membrane with matched verification is cleaned and sterilized.

4. The method for preparing an oral titanium membrane for guided bone regeneration of dental implants according to claim 1, characterized in that: In step 1, the oral imaging data includes cone beam CT (CBCT) scanning data, intraoral scanning data and facial scanning data; when constructing the three-dimensional model, the three-dimensional data of the patient's oral and maxillofacial area is obtained by combining cone beam CT with the intraoral scanning data and facial scanning data, and these data are used for three-dimensional reconstruction to generate a three-dimensional model corresponding to the oral defect area.

5. The method for preparing an oral titanium membrane for guided bone regeneration of dental implants according to claim 1, characterized in that: The gap between the male mold and the female mold is the thickness of the titanium mesh plate to be pressed, and the size of the gap is 0.1 mm to 0.5 mm.

6. The method for preparing an oral titanium membrane for guided bone regeneration of dental implants according to claim 1, characterized in that: In step 3, the pressing operation is performed by placing the titanium mesh plate between the male mold and the female mold and then applying pressure to the mold at room temperature. The pressing operation adopts a gradual pressurization method so that the titanium mesh plate undergoes plastic deformation under pressure to form a shaped titanium film that matches the defective area of ​​the patient's oral cavity. The pressure application process of the mold is controlled by mechanical or hydraulic equipment.

7. The method for preparing an oral titanium membrane for guided bone regeneration of dental implants according to claim 1, characterized in that: In step 2, the male mold and the female mold are designed and manufactured based on the three-dimensional model obtained in step 1, and the specific process includes: Step 2.1, the three-dimensional model obtained by three-dimensional reconstruction is combined with the specific size and curvature characteristics of the patient's oral defect area and the expected bone augmentation requirements of the attending physician, and the relative positions of the titanium mesh after simulated implantation and the adjacent teeth and nerves are considered, and the titanium mesh is simulated implanted on the three-dimensional model to meet the morphological requirements of the expected bone augmentation area; Step 2.2, according to the data of the simulated implanted titanium mesh, the digital design of the male mold and the female mold to be produced is performed to ensure that the designed mold can have a pressing profile that is compatible with the shape of the simulated implanted titanium mesh, thereby obtaining the processing data of the male mold and the female mold to be produced; Step 2.3, the male mold and the female mold are manufactured by CNC machining technology, and after the mold machining is completed, the male mold and the female mold are surface polished; Step 2.4: According to the patient's oral data and the actual needs of titanium film molding, the gap of the mold is fine-tuned and trimmed to obtain the required mold.

8. The method for preparing an oral titanium membrane for guided bone regeneration of dental implants according to claim 1, characterized in that: The mold is made of high-strength alloy steel, and the high-strength alloy steel used is selected from H13 mold steel, SKD11 mold steel and D2 mold steel.

9. The method for preparing an oral titanium membrane for guided bone regeneration of dental implants according to claim 1, characterized in that: In step 4, the cutting operation is performed by using a shearing tool to remove the excess part of the molded titanium film, and the cutting process is performed along the patterned area of ​​the titanium film to avoid damage to the surface structure of the titanium film; after cutting, the edge of the titanium film is polished using sandpaper or a grinding tool to ensure that the edge of the titanium film is smooth and has no sharp parts, thereby reducing mechanical stimulation to the patient's soft tissue.

10. The method for preparing an oral titanium membrane for guided bone regeneration of dental implants according to claim 1, characterized in that: The thickness of the titanium mesh plate is 0.1 mm to 0.5 mm, and the material of the titanium mesh plate is titanium alloy or titanium metal.

Images