Alveolar bone increment barrier membrane and preparation method thereof

Abstract

The invention relates to the technical field of medical instruments, in particular to an alveolar bone increment barrier membrane and a preparation method thereof. The alveolar bone increment barrier film provided by the invention comprises a zirconium oxide film prepared by a 3D printing technology; the alveolar bone increment barrier membrane comprises an alveolar ridge surface, a lip side surface and a tongue side surface, wherein the lip side surface and the tongue side surface are positioned on two opposite sides of the alveolar ridge surface; fixing holes are formed in the lip side surface and / or the tongue side surface, and the total number of the fixing holes is at least two; air holes are formed in the alveolar ridge surface. The alveolar bone increment barrier membrane disclosed by the invention has excellent mechanical property and biocompatibility and low tissue viscosity; the device can be better attached to the defect of the alveolar bone of a patient.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an alveolar bone augmentation barrier membrane and a preparation method thereof. Background Art

[0002] Horizontal and vertical alveolar bone defects caused by trauma, tumor resection, inflammation, tooth loss, etc. pose a great challenge to implant restoration. Guided Bone Generation (GBR) is a bone augmentation technique widely used in oral implantology and periodontal clinics. GBR refers to establishing a biological barrier between the gingival soft tissue and the defect site to block the growth of epithelial and fibroblast cells into the bone defect area, providing a relatively closed environment for osteoblast proliferation and new bone formation. An ideal GBR membrane not only requires good mechanical properties, space maintenance properties, and clinical operability, but also good biocompatibility, bioactivity, tissue selectivity, etc., to adapt to the complex oral tissue environment and promote new bone formation.

[0003] The key to guided bone regeneration lies in the selection of the barrier membrane material. Currently, the most widely used in clinical practice are titanium meshes and collagen membranes. Titanium meshes have the characteristics of high stiffness, good plasticity, and good biocompatibility; however, there are problems such as inaccurate manual bending and shaping during the operation, mucosal tearing, etc., which lead to an increase in the operation time and an increase in the risk probability of infection; during the healing stage, it will cause the risk of wound tearing and exposure; research shows that unless the operator is skilled, it will cause obstacles to the patient's occlusion and chewing functions after surgery. Collagen membranes have degradability, cell barrier properties, and good osteogenic ability; the disadvantage is that the duration of the barrier function is difficult to control, the degradation rate does not match the osteogenic time, the mechanical strength is poor, and bone tissue support is required to prevent collapse.

[0004] While meeting the mechanical properties and biological properties, the barrier membrane should have a high enough degree of customization freedom to be consistent with the defective alveolar bone and meet the personalized customization needs of users; this poses a challenge to the forming process, especially for products with a thin-walled structure such as bone augmentation barrier membranes, which are difficult to manufacture by traditional processing techniques, and problems such as high difficulty and high cost always exist.

[0005] In view of this, this invention is specifically proposed. Summary of the Invention

[0006] The first object of the present invention is to provide an alveolar bone augmentation barrier membrane, which has excellent mechanical properties, corrosion resistance, abrasion resistance, and biocompatibility, helps to promote local cell growth and bone regeneration, and has low tissue adhesiveness.

[0007] The second object of the present invention is to provide a preparation method of an alveolar bone augmentation barrier membrane, which has a simple process, is environmentally friendly and economical, has good formability, can better fit the alveolar bone defect site of patients, and meets the personalized customization needs of patients in clinical practice.

[0008] In order to achieve the above objects of the present invention, the following technical solutions are specifically adopted:

[0009] In the first aspect, the present invention provides an alveolar bone augmentation barrier membrane, which includes a zirconia membrane prepared by 3D printing technology;

[0010] The alveolar bone augmentation barrier membrane includes an alveolar ridge surface, a labial surface and a lingual surface, and the labial surface and the lingual surface are located on opposite sides of the alveolar ridge surface;

[0011] Fixing holes are provided on the labial surface and / or the lingual surface, and the total number of the fixing holes is at least two;

[0012] Ventilation holes are provided on the alveolar ridge surface.

[0013] Furthermore, it includes at least one of the following features (1) to (4);

[0014] (1) The aperture of the ventilation hole is 0.1-2 mm;

[0015] (2) The shape of the ventilation hole includes at least one of a triangle, a circle, a quadrilateral, a hexagon and a honeycomb circle;

[0016] (3) The aperture of the fixing hole is 1.2-3.2 mm;

[0017] (4) The shape of the fixing hole includes a circle.

[0018] Furthermore, it includes at least one of the following features (1) to (3);

[0019] (1) The thickness of the alveolar bone augmentation barrier membrane is 0.2-0.5 mm;

[0020] (2) The length of the alveolar bone augmentation barrier membrane is 10-100 mm, and the height is 5-20 mm;

[0021] (3) The cross-sectional shape of the alveolar bone augmentation barrier membrane includes a U shape.

[0022] In the second aspect, the present invention also provides a preparation method of the alveolar bone augmentation barrier membrane as described above, including the following steps:

[0023] S1. By performing a CT scan on the patient's oral cavity, 3D model data of the dentition and the jaw are obtained;

[0024] S2. Determine the alveolar bone defect structure based on the 3D model data of the dentition and jawbone, and construct a 3D structure model covering the alveolar bone defect site according to the alveolar bone defect structure;

[0025] S3. Import the 3D structure model into software, determine the placement position and support structure of the 3D structure model, and generate a slice file;

[0026] S4. Import the slice file into a stereolithography printing device, and print layer by layer to generate a zirconia embryo; successively clean, pre-treat, degrease, pre-sinter, sinter, and remove the support structure from the zirconia embryo to obtain the alveolar bone augmentation barrier membrane.

[0027] Further, in step S3, the support structure is arranged along the lower contour and / or side contour of the alveolar bone augmentation barrier membrane.

[0028] Further, in step S4, the power of the printing light source is 40 - 100 mJ / cm 2 , the exposure time for each layer is 0.5 - 2 s, and the slice thickness is 25 - 100 μm.

[0029] Further, in step S4, the pre-treatment includes: drying at 15 - 40 °C for 3 - 6 h.

[0030] Further, in step S4, the degreasing includes: performing heat preservation treatment at 200 - 600 °C for 2 - 6 h.

[0031] Further, in step S4, the pre-sintering includes: performing heat preservation treatment at 1000 - 1100 °C for 1 - 3 h, and then cooling in the furnace.

[0032] Further, in step S4, the sintering includes: performing heat preservation treatment at 1100 - 1550 °C for 1 - 3 h, and then cooling in the furnace.

[0033] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0034] 1. By using a zirconia membrane prepared by 3D printing technology as the alveolar bone augmentation barrier membrane, the present invention can accurately match the implantation site, has good sealing performance and space maintenance performance, enables there to be a relatively sufficient and stable space between the membrane and the tissue, can prevent the growth of epithelial connective tissue into the bone defect area, has more excellent biocompatibility and mechanical stability, greatly reduces problems such as bone resorption, bone inflammation, and secondary surgery, and its own color can also take into account the aesthetic effect; the air holes provided on the alveolar bone augmentation barrier membrane can allow oxygen, blood, and bioactive substances, etc. to enter, which helps to promote local cell growth and bone regeneration and avoid tissue adhesion.

[0035] 2. The preparation method of the alveolar bone augmentation barrier membrane of the present invention is customized through photocuring printing technology (3D printing), with high printing precision, which can better fit the alveolar bone defect site of patients, and can effectively overcome the problems in the prior art that the thin wall and complex pores of the alveolar bone augmentation barrier membrane obtained by numerical control milling cannot be processed, the waste of raw materials during the milling process, and the high cost. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following will briefly introduce the drawings required for the embodiments. It should be understood that the following drawings only show some embodiments of the present invention, so they should not be regarded as limiting the scope. For those of ordinary skill in the art, without creative efforts, other related drawings can also be obtained based on these drawings.

[0037] Figure 1 It is the alveolar bone model of the patient in Embodiment 1 of the present invention.

[0038] Figure 2 It is the model after simulating alveolar bone repair in Embodiment 1 of the present invention.

[0039] Figure 3 It is the 3D structure model that completely covers the alveolar bone defect site in Embodiment 1 of the present invention.

[0040] Figure 4 It is the fixing hole on the 3D structure model in Embodiment 1 of the present invention.

[0041] Figure 5 It is the ventilation hole on the 3D structure model in Embodiment 1 of the present invention.

[0042] Figure 6 It is the design of the support structure and porous bottom plate using Magics in Embodiment 1 of the present invention.

[0043] Figure 7 It is the physical diagram of the alveolar bone augmentation barrier membrane in Embodiment 1 of the present invention.

[0044] Figure 8 It is the picture of the alveolar bone augmentation barrier membrane in Embodiment 1 of the present invention matching the patient's dental model.

[0045] Figure 9 It is the comparison of the compression stiffness and maximum load of the mechanical test model printed with the printing parameters of Embodiment 1 of the present invention and the metal titanium mesh.

[0046] Figure 10 It is the cell viability of the alveolar bone augmentation barrier membrane in Embodiment 1 of the present invention.

[0047] Reference Signs:

[0048] 1 - Alveolar bone defect site; 2 - Model after alveolar bone repair; 3 - 3D structural model completely covering the alveolar bone defect site; 4 - Fixing hole; 5 - Ventilation hole. Detailed implementation mode

[0049] The technical solution of the present invention will be clearly and completely described below in conjunction with the drawings and specific implementation modes. However, those skilled in the art will understand that the following described embodiments are part of the embodiments of the present invention, rather than all embodiments, and are only used to illustrate the present invention and should not be regarded as limiting the scope of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention. For those conditions not specified in the embodiments, they are carried out according to the conventional conditions or the conditions recommended by the manufacturer. For those reagents or instruments without indicating the manufacturer, they are all conventional products that can be purchased commercially.

[0050] A detailed description of an alveolar bone augmentation barrier membrane and its preparation method according to an embodiment of the present invention will be given below.

[0051] In some embodiments of the present invention, an alveolar bone augmentation barrier membrane is provided, and the alveolar bone augmentation barrier membrane includes a zirconia membrane prepared by 3D printing technology;

[0052] The alveolar bone augmentation barrier membrane includes an alveolar crest surface, a labial surface, and a lingual surface, and the labial surface and the lingual surface are located on opposite sides of the alveolar crest surface;

[0053] Fixing holes are provided on the labial surface and / or the lingual surface, and the total number of fixing holes is at least two;

[0054] Ventilation holes are provided on the alveolar crest surface.

[0055] Zirconia is a polycrystalline ceramic. This material is biocompatible and shows high flexural strength even at very thin thicknesses; compared with titanium, it can better induce fibroblast proliferation, showing less biofilm adhesion and inflammatory reactions; compared with collagen membranes, it can provide stable space maintenance performance and reduce the probability of secondary surgery.

[0056] The alveolar bone augmentation barrier membrane of the present invention is made of a zirconia membrane prepared by 3D printing technology, which has excellent mechanical properties, corrosion resistance, wear resistance and biocompatibility; it can accurately match the implantation site, will not slip or loosen after implantation, and can play a good sealing and space maintenance function, so that there is a relatively sufficient and stable space between the membrane and the tissue, and it can prevent the growth of epithelial connective tissue into the bone defect area. It has better biocompatibility and mechanical stability than titanium metal, greatly reducing problems such as bone resorption, bone inflammation and secondary surgery caused by metal materials, and its own color can also take into account the aesthetic effect.

[0057] The alveolar bone augmentation barrier membrane of the present invention is provided with ventilation holes, which can allow oxygen, blood and bioactive substances to enter, help the transportation and metabolism of cell nutrients, guide the proliferation of fibroblasts, promote bone ingrowth, and promote local cell growth and bone regeneration; and can avoid tissue adhesion, has low tissue adhesiveness, can be easily removed, and reduces the surgical risk.

[0058] The alveolar bone augmentation barrier membrane of the present invention includes an alveolar ridge surface, a labial surface and a lingual surface. The labial surface is located on one side of the alveolar ridge surface; the lingual surface is located on the other side of the alveolar ridge surface and is opposite to the labial surface; the alveolar bone augmentation barrier membrane includes at least two fixing holes and at least one ventilation hole; the fixing holes are arranged on the labial surface, or the fixing holes are arranged on the lingual surface, or the fixing holes are arranged on the labial surface and the lingual surface; the ventilation holes are arranged on the alveolar ridge surface.

[0059] In some embodiments of the present invention, the aperture of the ventilation hole is 0.1 - 2 mm; typically but not restrictively, for example, the aperture of the ventilation hole can be 0.1 mm, 0.5 mm, 1 mm, 1.5 mm, 2 mm or a range value composed of any two of them.

[0060] In some embodiments of the present invention, the shape of the ventilation hole includes at least one of a triangle, a circle, a quadrilateral, a hexagon and a honeycomb circle.

[0061] The ventilation holes provided on the alveolar bone augmentation barrier membrane of the present invention can establish blood supply and promote metabolism in the alveolar bone defect area, and can regulate the formation of bone tissue and soft tissue in the repair of alveolar bone defects.

[0062] In some embodiments of the present invention, the aperture of the fixing hole is 1.2 - 3.2 mm; typically but not restrictively, for example, the aperture of the fixing hole can be 1.2 mm, 1.5 mm, 2 mm, 2.5 mm, 3.0 mm, 3.2 mm or a range value composed of any two of them.

[0063] In some embodiments of the present invention, the shape of the fixing hole includes a circle.

[0064] In some embodiments of the present invention, two fixing holes are provided on the lingual side or the labial side of the alveolar bone augmentation barrier membrane, and two rows of ventilation holes are provided on the alveolar ridge surface (the top of the barrier membrane); preferably, the vertical distance between the two rows of ventilation holes is 3-6 mm, and the vertical distance between two adjacent ventilation holes in each row is 1-3 mm; the distance between the two rows of ventilation holes and between two adjacent ventilation holes in each row is determined according to the difference in the model shape and the ventilation hole selection type, and is determined according to the scanned barrier membrane specifications and morphology. At the same time, the equipment printing ability and the barrier membrane strength should also be taken into account.

[0065] In some embodiments of the present invention, the thickness (wall thickness) of the alveolar bone augmentation barrier membrane is 0.2-0.5 mm; typically but not restrictively, for example, the thickness of the alveolar bone augmentation barrier membrane can be 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm or a range value composed of any two of them.

[0066] When the thickness of the alveolar bone augmentation barrier membrane of the present invention is within the above range, it can provide sufficient mechanical properties, maintain the volume of the bone graft material during the wound healing process, and provide sufficient space support and barrier for the repair of the alveolar bone horizontal bone thickness and vertical bone height; it can reduce the foreign body sensation after the barrier membrane implantation and reduce the risk of the patient's second operation; at the same time, as the alveolar bone repair area increases, the thickness of the barrier membrane also increases appropriately to maintain sufficient repair space.

[0067] In some embodiments of the present invention, the length of the alveolar bone augmentation barrier membrane is 10-100 mm, and the height is 5-20 mm; typically but not restrictively, for example, the length of the alveolar bone augmentation barrier membrane can be 10 mm, 20 mm, 40 mm, 60 mm, 80 mm, 100 mm or a range value composed of any two of them; the height of the alveolar bone augmentation barrier membrane can be 5 mm, 10 mm, 15 mm, 20 mm or a range value composed of any two of them.

[0068] In some embodiments of the present invention, the cross-sectional shape of the alveolar bone augmentation barrier membrane includes a U shape.

[0069] In some embodiments of the present invention, a preparation method of the above alveolar bone augmentation barrier membrane is also provided, including the following steps:

[0070] S1. By performing a CT scan on the patient's oral cavity, 3D model data of the dentition and the jaw are obtained;

[0071] S2. According to the 3D model data of the dentition and the jaw, the alveolar bone defect structure is determined, and a 3D structure model covering the alveolar bone defect site is constructed according to the alveolar bone defect structure;

[0072] S3. Import the 3D structure model into the software, determine the placement position and support structure of the 3D structure model, and generate a slice file;

[0073] S4. Import the slice file into the stereolithography printing device and print layer by layer to generate a zirconia green body; successively clean, pre-treat, degrease, pre-sinter, sinter and remove the support structure of the zirconia green body to obtain an alveolar bone augmentation barrier membrane.

[0074] The present invention combines stereolithography printing technology (3D printing) with digital modeling technology for the personalized customization of alveolar bone augmentation barrier membranes (zirconia membranes), which can effectively overcome the problems in the prior art that thin walls and complex porous structures of zirconia products obtained by numerical control milling cannot be processed, avoid waste of raw materials during the milling process, and the high cost; according to the defect site of the reconstructed alveolar bone model, the expected bone augmentation range, and the number and position of fixation pins, accurately design the contour of the personalized alveolar bone augmentation barrier membrane; at the same time, support formulating the surgical plan in advance, eliminating the excessive dependence on the doctor's shaping technology during the operation, greatly shortening the operation time, and reducing the operation risk.

[0075] Stereolithography printing uses digital light processing technology. Digital light processing (DLP printing) has the advantages of simple process, environmental protection and economy, and good formability, and can better fit the alveolar bone defect of the patient to meet the personalized customization needs of patients in clinical practice.

[0076] In some embodiments of the present invention, in step S1, by performing a CT scan on the patient's oral cavity, 3D model data of the dentition and jaw are obtained, imported into the software, and the alveolar bone model of the patient is reconstructed to obtain the alveolar bone defect site.

[0077] In some embodiments of the present invention, in step S2, according to the alveolar bone model of the patient, the alveolar bone defect structure is determined; the model after alveolar bone repair is simulated in the software, and a 3D structure model that completely covers the alveolar bone defect site is designed and generated in situ on the basis of this model;

[0078] The 3D structure model is designed as follows: the cross-sectional shape includes a U shape; the overall dimensions are 10 - 100 mm in length, 5 - 20 mm in height, and 0.2 - 0.5 mm in thickness (wall thickness); at least one air hole is provided on the surface, and the shape of the air hole includes at least one of a triangle, a circle, a quadrilateral, a hexagon and a honeycomb circle, and the pore diameter is 0.1 - 2 mm; at least two fixing holes are provided on the surface, and the shape of the fixing hole includes a circle, and the pore diameter is 1.2 - 3.2 mm.

[0079] In some embodiments of the present invention, in step S3, the support structure is arranged along the lower contour and / or the side contour of the alveolar bone augmentation barrier membrane; preferably, a midpoint support of Magics 27.0 (in direct contact with the barrier membrane entity) is arranged along the lower contour and / or the side contour of the alveolar bone augmentation barrier membrane.

[0080] In some embodiments of the present invention, in step S4, the power of the printing light source is 40 - 100 mJ / cm 2 , the exposure time for each layer is 0.5 - 2 s, and the slice thickness is 25 - 100 μm; typically but not restrictively, for example, the power of the printing light source can be 40 mJ / cm 2 , 60 mJ / cm 2 , 80 mJ / cm 2 , 100 mJ / cm 2 or a range value composed of any two of them; the exposure time for each printed layer can be 0.5 s, 1.0 s, 1.5 s, 2 s or a range value composed of any two of them; the printed slice thickness can be 25 μm, 40 μm, 60 μm, 80 μm, 100 μm or a range value composed of any two of them.

[0081] In some embodiments of the present invention, in step S4, the cleaning includes: washing with water for 5 - 10 min.

[0082] In some embodiments of the present invention, in step S4, the pretreatment includes: drying at 15 - 40 °C for 3 - 6 h; preferably, the drying includes natural drying or drying in an oven.

[0083] In some embodiments of the present invention, in step S4, the degreasing includes: heat preservation treatment at 200 - 600 °C for 2 - 6 h; typically but not restrictively, for example, the degreasing temperature can be 200 °C, 300 °C, 400 °C, 500 °C, 600 °C or a range value composed of any two of them; the degreasing time can be 2 h, 3 h, 4 h, 5 h, 6 h or a range value composed of any two of them; preferably, the heating rate during degreasing is 0.2 - 5 °C / min; typically but not restrictively, for example, the heating rate during degreasing can be 0.2 °C / min, 1 °C / min, 2 °C / min, 3 °C / min, 4 °C / min, 5 °C / min or a range value composed of any two of them.

[0084] In some embodiments of the present invention, in step S4, the pre-sintering includes: after heat preservation treatment at 1000 - 1100°C for 1 - 3 h, furnace cooling; typically but not restrictively, for example, the pre-sintering temperature can be 1000°C, 1050°C, 1100°C or a range value composed of any two of them; preferably, the pre-sintering time is 2 h; the heating rate during the pre-sintering process is 2 - 5°C / min; typically but not restrictively, for example, the heating rate during the pre-sintering process can be 2°C / min, 3°C / min, 4°C / min, 5°C / min or a range value composed of any two of them.

[0085] In some embodiments of the present invention, in step S4, the sintering includes: after heat preservation treatment at 1100 - 1550°C for 1 - 3 h, furnace cooling; typically but not restrictively, for example, the sintering temperature can be 1100°C, 1200°C, 1300°C, 1400°C, 1500°C, 1550°C or a range value composed of any two of them; preferably, the sintering time is 2 h; the heating rate during the sintering process is 1.5 - 5°C / min; typically but not restrictively, for example, the heating rate during the sintering process can be 1.5°C / min, 3°C / min, 4.5°C / min, 5°C / min or a range value composed of any two of them.

[0086] Example 1

[0087] The preparation method of the alveolar bone augmentation barrier membrane provided in this embodiment includes the following steps:

[0088] S1. Refer to Figure 1 , by performing a CT scan on the patient's oral cavity, obtaining the 3D model data of the dentition and jawbone, importing it into the software, reconstructing the patient's alveolar bone model, and obtaining the alveolar bone defect site 1;

[0089] S2. Refer to Figure 2 , according to the patient's alveolar bone model, determining the alveolar bone defect structure, and simulating the model 2 after alveolar bone repair in the software; refer to Figure 3 , on the basis of this model, in-situ designing and generating a 3D structural model 3 that completely covers the alveolar bone defect site; refer to Figure 4 and Figure 5 , two fixing holes 4 and two rows of ventilation holes 5 are designed on the 3D structural model;

[0090] S3. Refer to Figure 6 , importing the 3D structural model into the software, determining the placement position of the 3D structural model, and using Magics to design the support structure and porous bottom plate to generate a slice file; wherein, the support structure is arranged along the lower contour and / or side contour of the alveolar bone augmentation barrier membrane by point support (in direct contact with the barrier membrane entity) in Magics 27.0; Figure 6In a, it is the design of a single-tooth alveolar bone augmentation barrier membrane; Figure 6 In b, it is the design of a three-tooth alveolar bone augmentation barrier membrane;

[0091] S4. Import the slice file into the DLP printing device and print layer by layer to generate a zirconia green body; the power of the printing light source is 40 mJ / cm 2 , the exposure time for each layer is 2 s, and the slice thickness is 25 μm;

[0092] Put the printed zirconia green body into pure water and wash it for 5 min to remove the residual slurry. After natural drying for 6 h, perform debinding, pre-sintering, sintering, and removal of the support structure in sequence to obtain the alveolar bone augmentation barrier membrane; among them, debinding includes: in a debinding furnace, heat up to 600 °C at a rate of 0.2 °C / min and hold for 6 h; pre-sintering includes: heat up to 1000 °C at a rate of 2 °C / min and hold for 2 h, then cool in the furnace; sintering includes: heat up to 1100 °C at a rate of 1.5 °C / min and hold for 2 h, then cool in the furnace.

[0093] The alveolar bone augmentation barrier membrane prepared in this embodiment is as Figure 7 shown; the alveolar bone augmentation barrier membrane is a zirconia membrane prepared by 3D printing technology; the alveolar bone augmentation barrier membrane includes an alveolar crest surface, a labial surface, and a lingual surface, the labial surface is located on one side of the alveolar crest surface; the lingual surface is located on the other side of the alveolar crest surface and is opposite to the labial surface; the cross-sectional shape is U-shaped; the overall dimensions are 20 mm in length, 5 mm in height, and 0.3 mm in thickness (wall thickness); there are two rows of circular ventilation holes on the alveolar crest surface (the top of the barrier membrane), the pore diameter of the ventilation holes is 250 μm, the vertical distance between the two rows of ventilation holes is 3.5 - 4.5 mm, and the vertical distance between adjacent two ventilation holes in each row is 1 - 2 mm; there are two circular fixing holes on the labial surface, and the pore diameter of the fixing holes is 1.2 mm; a picture of the alveolar bone augmentation barrier membrane matching the patient's dental model is as Figure 8 shown.

[0094] Example 2

[0095] The preparation method of the alveolar bone augmentation barrier membrane provided in this embodiment includes the following steps:

[0096] S1. By performing a CT scan on the patient's oral cavity (the same patient as in Example 1), obtain the 3D model data of the dentition and jaws, import it into the software, reconstruct the patient's alveolar bone model, and obtain the alveolar bone defect site;

[0097] S2. According to the patient's alveolar bone model, determine the alveolar bone defect structure, and simulate the model after alveolar bone repair in the software; on the basis of this model, in-situ design and generate a 3D structure model that completely covers the alveolar bone defect site; the 3D structure model is designed with fixing holes and ventilation holes;

[0098] S3. Import the 3D structural model into the software, determine the placement position of the 3D structural model, use Magics to design the support structure and the porous bottom plate, and generate a sliced file. Among them, the support structure is arranged along the lower contour or the side contour of the alveolar bone augmentation barrier membrane by point support (in direct contact with the barrier membrane entity) in Magics 27.0.

[0099] S4. Import the sliced file into the DLP printing device and print layer by layer to generate a zirconia green body. The power of the printing light source is 100 mJ / cm 2 , the exposure time for each layer is 2 s, and the sliced thickness is 100 μm.

[0100] Put the printed zirconia green body into pure water for cleaning for 10 min to remove the residual slurry, place it in an oven at 35 °C for drying for 3 h, and then perform degreasing, pre-sintering, sintering, and removing the support structure in sequence to obtain the alveolar bone augmentation barrier membrane. Among them, degreasing includes: in the degreasing furnace, heating up to 500 °C at a rate of 1.5 °C / min and holding for 2 h; pre-sintering includes: heating up to 1100 °C at a rate of 5 °C / min and holding for 2 h, and then cooling in the furnace; sintering includes: heating up to 1550 °C at a rate of 5 °C / min and holding for 2 h, and then cooling in the furnace.

[0101] The alveolar bone augmentation barrier membrane prepared in this embodiment is a zirconia membrane prepared by 3D printing technology. The alveolar bone augmentation barrier membrane includes an alveolar ridge surface, a labial surface, and a lingual surface. The labial surface is located on one side of the alveolar ridge surface; the lingual surface is located on the other side of the alveolar ridge surface and is opposite to the labial surface; the cross-sectional shape is U-shaped; the overall dimensions are 25 mm in length, 10 mm in height, and 0.2 mm in thickness (wall thickness); there are two circular fixing holes on both the labial surface and the lingual surface, and the aperture of the fixing hole is 2 mm; there are two rows of circular ventilation holes on the alveolar ridge surface (the top of the barrier membrane), and the aperture of the ventilation hole is 1.2 mm.

[0102] Test Example

[0103] Test the compressive stiffness and maximum load of the mechanical test model printed with the printing parameters of Example 1 (the zirconia membrane printed with the printing parameters of Example 1, i.e., the zirconium membrane) and the titanium mesh. The results are as Figure 9 shown.

[0104] From Figure 9 it can be seen that the two mechanical property indexes of the compressive stiffness and the maximum load of the zirconium membrane are far higher than those of the titanium mesh, providing sufficient space support and barrier for the repair of the alveolar bone horizontal bone thickness and vertical bone height, and avoiding the risk of secondary surgery caused by space collapse after implantation.

[0105] The extract of the alveolar bone augmentation barrier membrane of Example 1 was used to culture cells (mouse fibroblasts (L929)) to obtain cell viability data. The results are as follows: Figure 10 shown.

[0106] Figure 10 In the experiment, 25% extraction was performed by culturing cells in a culture medium consisting of 25 wt% of an extract and 75 wt% of a conventional culture medium. The extract was the culture medium used to soak the alveolar bone augmentation barrier membrane. 50% extraction, 75% extraction, and 100% extraction were performed by analogy. The control group was cultured with a conventional culture medium (100%). The extract preparation and cell culture procedures were in accordance with the national standard GB / T 16886.5-2017.

[0107] from Figure 10 It can be seen that compared with the control group, there was no significant difference in the cell viability of mouse fibroblasts (L929) cultured with 25%, 50%, 75% and 100% extraction, and the cell viability was greater than 85%, indicating that the barrier membrane has no potential cytotoxicity and can support postoperative repair of alveolar bone defects.

[0108] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An alveolar bone augmentation barrier membrane, characterized in that: The alveolar bone augmentation barrier membrane includes a zirconia membrane prepared by 3D printing technology; The alveolar bone augmentation barrier membrane includes an alveolar ridge surface, a labial surface, and a lingual surface, and the labial surface and the lingual surface are located on opposite sides of the alveolar ridge surface; Fixing holes are provided on the labial surface and / or the lingual surface, and the total number of the fixing holes is at least two; Ventilation holes are provided on the alveolar ridge surface.

2. The alveolar bone augmentation barrier membrane according to claim 1, wherein It includes at least one of the following features (1) to (4); (1) The aperture of the ventilation hole is 0.1 - 2 mm; (2) The shape of the ventilation hole includes at least one of a triangle, a circle, a quadrilateral, a hexagon, and a honeycomb circle; (3) The aperture of the fixing hole is 1.2 - 3.2 mm; (4) The shape of the fixing hole includes a circle.

3. The alveolar bone augmentation barrier membrane according to claim 1, characterized in that, It includes at least one of the following features (1) to (3); (1) The thickness of the alveolar bone augmentation barrier membrane is 0.2 - 0.5 mm; (2) The length of the alveolar bone augmentation barrier membrane is 10 - 100 mm, and the height is 5 - 20 mm; (3) The cross-sectional shape of the alveolar bone augmentation barrier membrane includes a U shape.

4. The preparation method of the alveolar bone augmentation barrier membrane according to any one of claims 1 to 3, characterized in that, It includes the following steps: S1. Obtain 3D model data of the dentition and the jaw by performing a CT scan on the patient's oral cavity; S2. Determine the alveolar bone defect structure according to the 3D model data of the dentition and the jaw, and construct a 3D structure model covering the alveolar bone defect site according to the alveolar bone defect structure; S3. Import the 3D structure model into software, determine the placement position and the support structure of the 3D structure model, and generate a slice file; S4. Import the slice file into a stereolithography printing device, and print layer by layer to generate a zirconia embryo; The zirconia embryo is successively cleaned, pretreated, degreased, pre-sintered, sintered, and the support structure is removed to obtain the alveolar bone augmentation barrier membrane.

5. The method for preparing the alveolar bone augmentation barrier membrane according to claim 4, characterized in that: In step S3, the support structure is arranged along the lower contour and / or the side contour of the alveolar bone augmentation barrier membrane.

6. The preparation method of the alveolar bone augmentation barrier membrane according to claim 4, characterized in that, In step S4, the light source power of the printing is 40-100 mJ / cm 2 The exposure time for each layer is 0.5 to 2 s, and the slice thickness is 25 to 100 μm.

7. The preparation method of the alveolar bone augmentation barrier membrane according to claim 4, wherein In step S4, the pretreatment includes: drying at 15 - 40 °C for 3 - 6 h.

8. The method for preparing the alveolar bone augmentation barrier membrane according to claim 4, characterized in that: In step S4, the degreasing includes: performing heat preservation treatment at 200 - 600 °C for 2 - 6 h.

9. The preparation method of the alveolar bone augmentation barrier membrane according to claim 4, characterized in that, In step S4, the pre-sintering includes: performing heat preservation treatment at 1000 - 1100 °C for 1 - 3 h and then cooling in the furnace.

10. The preparation method of the alveolar bone augmentation barrier membrane according to claim 4, wherein In step S4, the sintering includes: performing heat preservation treatment at 1100 - 1550 °C for 1 - 3 h and then cooling in the furnace.

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