Bone regeneration barrier member and preparation system

Abstract

The invention discloses a bone regeneration barrier component and a preparation system, and the bone regeneration barrier component comprises a nail body, the surface of which is provided with a self-tapping thread; the covering part is detachably connected to the nail body, and the size and the shape of the covering part are matched with the shape of a defect area in the oral cavity of a patient; a medicine release channel is arranged in the nail body, and medicine is arranged in the medicine release channel. A plurality of micropores are formed in the outer wall of the nail body, and the micropores are communicated with the outside and the medicine release channel so as to release medicine. Therefore, the covering part can be perfectly matched with a defect area and is fixed by being matched with a single nail body, the covering part can be installed, the fixing mode is simple, the stress concentration phenomenon can be effectively reduced, meanwhile, the medicine release time can be prolonged, and the treatment effect on a patient can be guaranteed.

Description

Technical Field

[0001] This invention relates to the field of dental medical device technology, and in particular to a bone regeneration barrier component and its preparation system. Background Technology

[0002] Oral bone defect repair is a key step in treatments such as dental implants and jawbone reconstruction.

[0003] Traditional bone regeneration techniques primarily rely on barrier membranes (such as collagen membranes) to maintain space and cover the bone defect area, thereby reducing the loss of bone repair materials (bone powder) in the defect area. However, clinical practice has revealed significant shortcomings in this technique. Due to the lack of sufficient rigidity in the membrane material itself, it is prone to collapse under the frequent movements of oral muscles and the pressure generated by chewing, which in turn causes the bone repair material to shift, affecting the repair effect.

[0004] Therefore, in recent years, titanium mesh has been widely used to achieve rigid support in pre-implantation bone tissue repair. While this method has successfully solved the problem of membrane material collapse, it has also created new challenges in practice. To ensure the stability of the titanium mesh, doctors typically need to use multiple titanium screws to fix it to the bone surface. However, due to the confined operating space, limited field of vision, and the presence of bleeding, the titanium screw fixation process is not only difficult to perform, but the fixation effect often falls short of expectations. Furthermore, the presence of multiple titanium screws creates stress at the fixation points between the screws and the mesh, and this stress is difficult to completely release after fixation, potentially leading to problems such as localized bone resorption. In addition, traditional drugs for improving bone tissue regeneration are usually simply mixed with bone repair materials and filled into the bone defect area, resulting in a burst release effect. This causes the drugs to be released rapidly in a short period after implantation, affecting the patient's treatment outcome. Summary of the Invention

[0005] The present invention aims to at least partially solve one of the technical problems in the related art.

[0006] Therefore, one objective of this invention is to provide a bone regeneration barrier component and its preparation system that can perfectly fit the defect area. With the help of a single nail fixation, the installation of the cover can be completed. The fixation method is simple and can effectively reduce stress concentration. At the same time, it can prolong the drug release time and ensure the treatment effect on the patient.

[0007] To achieve the above objectives, a first aspect of the present invention provides a bone regeneration barrier component, comprising: a nail body with self-tapping threads on its surface; a cover detachably connected to the nail body, the size and shape of which are adapted to the morphology of the defect area in the patient's oral cavity; a drug release channel is provided inside the nail body, the drug release channel being provided with a drug; and a plurality of micropores are provided on the outer wall of the nail body, the micropores communicating with the outside and the drug release channel to release the drug.

[0008] The bone regeneration barrier component of this invention features a cover whose size and shape are adapted to the morphology of the defect area in the patient's oral cavity, significantly improving the fit between the cover and the defect area. Installation of the cover can be completed using a single screw fixation method, which is simple and effectively reduces stress concentration. The medication is placed in a drug release channel, meaning the medication is placed inside the screw and released through micropores, achieving gradient release and prolonging the drug release time. This provides strong support for the sustained therapeutic effect and ensures optimal treatment outcomes for the patient.

[0009] In addition, the bone regeneration barrier component proposed in the application may also have the following additional technical features:

[0010] Specifically, the drug release channel is provided with at least one degradable separator membrane to divide the drug release channel into multiple storage areas, wherein multiple micropores are located in one of the storage areas adjacent to the tip of the nail body.

[0011] Specifically, the drugs in the multiple storage areas are the same, wherein the drugs may be growth factors.

[0012] Specifically, the drugs in the multiple storage areas are not the same.

[0013] Specifically, there are two separator membranes to divide the drug release channel into three storage areas, with the spikes pointing towards the cover. The three storage areas are loaded with antibiotics, growth factors, and microvesicles, respectively.

[0014] Specifically, the surface of the nail body adjacent to the cover is provided with a nano-hydroxyapatite coating with a coating thickness of 50-200 nm.

[0015] Specifically, it also includes a collagen membrane and a fixing element, wherein the collagen membrane is adhered to the cover and the fixing element is used to fix the cover and the collagen membrane together to the nail body.

[0016] Specifically, the cover has multiple through holes.

[0017] Specifically, the porosity of the through holes on the cover is 30-70%, and the pore diameter is 1-3 mm.

[0018] A second aspect of the present invention provides a fabrication system for a bone regeneration barrier component as described in the first aspect of the present invention, comprising: a three-dimensional scanning module for acquiring morphological data of a patient's bone defect area; a data processing terminal communicatively connected to the three-dimensional scanning module for calculating the size and curvature parameters of the covering component based on the morphological data and generating a three-dimensional model; and a three-dimensional printing module communicatively connected to the data processing terminal for manufacturing the covering component according to the three-dimensional model. Attached Figure Description

[0019] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0020] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This is a schematic diagram of the structure of a bone regeneration barrier component according to an embodiment of the present invention;

[0022] Figure 2 This is a cross-sectional structural schematic diagram of a bone regeneration barrier component according to an embodiment of the present invention;

[0023] Figure 3 A top view of a cover according to an embodiment of the present invention;

[0024] Figure 4 In accordance with the present invention Figure 2 A magnified structural diagram of area A in the middle.

[0025] As shown in the figure: 10, nail body; 100, self-tapping thread; 101, drug release channel; 102, micropore; 1010, storage area;

[0026] 11. Cover part; 110. Through hole; 111. Through hole;

[0027] 12. Separating membrane;

[0028] 13. Collagen membrane; 131. Stepped pores;

[0029] 14. Fasteners. Detailed Implementation

[0030] To better understand the above-mentioned objectives, features, and advantages of the present invention, the solutions of the present invention will be further described below. It should be noted that, unless otherwise specified, the embodiments of the present invention and the features thereof can be combined with each other.

[0031] Many specific details are set forth in the following description in order to provide a full understanding of the invention, but the invention may also be practiced in other ways different from those described herein; obviously, the embodiments in the specification are only some embodiments of the invention, and not all embodiments.

[0032] The bone regeneration barrier component and preparation system of the present invention will be described below with reference to the accompanying drawings.

[0033] The bone regeneration barrier component of this invention is suitable for clinical scenarios such as alveolar bone defect repair and peri-implant bone augmentation.

[0034] like Figure 1 and Figure 2 As shown, the bone regeneration barrier component of the first aspect of the present invention may include a nail body 10 and a cover 11.

[0035] The nail body 10 has a self-tapping thread 100 on its surface, which enables minimally invasive implantation and initial stability of the nail body 10. The self-tapping thread 100 can be a progressive thread, a variable tooth profile thread, or an equidistant thread, with a progressive thread being preferred. The pitch is designed to be continuously and gradually varied along the axial direction, and can be gradually increased or decreased from the proximal end to the distal end of the nail body 10 to adapt to the progressive engagement requirements of different bone density areas. The pitch gradient design makes the resistance change in gradient when the thread cuts into the bone tissue, reducing the peak stress in the early stage of implantation and reducing the risk of bone burns. In addition, the pitch variation can match the different density characteristics of cortical bone and cancellous bone. A small pitch is used in the proximal end (high density area) to ensure the initial anchoring force, and a large pitch is used in the distal end (low density area) to prevent stress concentration.

[0036] The cover 11 is detachably connected to the nail body 10. The size and shape of the cover 11 are adapted to the shape of the defect area in the patient's oral cavity. This means that the size and shape of the cover 11 can be customized according to the specific shape of the defect area in the oral cavity of different patients, thereby significantly improving the fit between the cover 11 and the shape of the defect area and reducing the loss rate of bone powder. The thickness of the cover 11 can be 0.1-0.4mm, with blunt edges, which can reduce damage to soft tissues during installation.

[0037] Compared to existing technologies that use multiple titanium screws to fix the titanium mesh, this application only requires a single screw body and a cover 11 that matches the shape of the defect area in the patient's oral cavity to cover and shield the bone defect area. The fixation method is simple and can effectively reduce stress concentration. In addition, the cover 11 is digitally designed based on the patient's preoperative CBCT and intraoral scan data. The prefabricated shape matches the defect area in an "on-demand" manner, without the need for intraoperative adjustments, which significantly reduces the difficulty of surgical operation and shortens the operation time.

[0038] The nail body 10 has a drug release channel 101 inside, which contains a drug. The outer wall of the nail body 10 has multiple micropores 102, which connect to the outside and the drug release channel 101 to release the drug. The pore size of the micropores 102 is between 100-500 μm. The pore sizes of the multiple micropores 102 can be all the same, or they can gradually increase or decrease in size.

[0039] In the above-described approach, by placing the sustained-release drug within the drug release channel 101—that is, placing the drug inside the nail body 10—and releasing the drug through the micropores 102, a gradient release is achieved, extending the drug release time and providing a strong guarantee for the sustained therapeutic effect. Compared to the traditional method of directly mixing the drug with bone repair materials, this approach effectively avoids the problem of burst release. Traditional simple mixing often results in a large release of the drug in a short period of time, which not only makes it difficult to maintain a controllable drug concentration but may also pose unnecessary risks to the patient. This approach, however, ensures that the drug exerts its effect continuously in the body at an appropriate rate and dosage through precise control of drug release, significantly improving the overall therapeutic effect.

[0040] It should be noted that both the nail body 10 and the cover 11 are made of medical-grade pure titanium with a purity of not less than 99.99%, which has good biocompatibility, ensuring the physiological compatibility of the bone regeneration barrier component of this application with soft and hard tissues, reducing the risk of immune rejection. In addition, the elastic modulus of pure titanium is closer to that of cortical bone, which can significantly reduce the stress shielding effect and improve the regeneration effect compared with titanium alloy.

[0041] Furthermore, such as Figure 2 As shown, at least one degradable separator 12 is provided in the drug release channel 101 to divide the drug release channel 101 into multiple storage areas 1010. The separator 12 is made of a degradable material. Preferably, the degradable material is polylactic acid-glycolic acid copolymer (PLGA), which has good biocompatibility and degradability and can gradually disintegrate upon contact with liquid.

[0042] It should be noted that the number of separators 12 can be 1, 2, 3, etc., and can be set according to the actual situation. For example, refer to... Figure 2 There is one separator membrane 12 and two storage areas 1010. The materials of the multiple separator membranes 12 can be degradable materials with the same degradation rate or degradable materials with different degradation rates.

[0043] Multiple micropores 102 are located in a storage area 1010 near the tip of the nail body 10, which ensures that only the drug in the lowest storage area 1010 can be released through the micropores 102, while the drug in the other storage areas 1010 can only be released when it falls into the storage area 1010 connected to the micropores 102.

[0044] In the above scheme, during the disintegration of the separator membrane 12, the drug located in the upper storage region 1010 is released into the lower storage region 1010. Each degradation of the separator membrane 12 triggers the next stage of drug release. That is, as the upper separator membrane 12 degrades, the drug originally separated in the upper storage region 1010 is released and diffuses into the lower storage region 1010. This process is not instantaneous, but rather exhibits an orderly and gradual release pattern based on the degradation rate of the separator membrane 12 and the diffusion characteristics of the drug.

[0045] Through this progressive and orderly triggered drug release mechanism, the duration of drug release in the body is significantly prolonged. The drug can be released continuously at a relatively controllable rate, avoiding drastic fluctuations in drug concentration, thereby maintaining a relatively constant effective drug concentration in the body, fully exerting the therapeutic effect, and improving the efficacy and safety of treatment.

[0046] In one embodiment of the present invention, the drugs in the multiple storage areas 1010 are the same, wherein the drugs may be growth factors, wherein the growth factor is BMP-2 growth factor sustained-release gel.

[0047] In the above scheme, growth factors (such as BMP-2) are encapsulated in independent storage areas 1010 through multi-layer septa membranes 12, achieving "segmented activation" release. Each septa membrane 12 releases a quantitative amount of growth factors after degradation, maintaining continuous biological activity during the critical period of bone repair (0-12 weeks).

[0048] Furthermore, when the material of the septum 12 is selected as a biodegradable material, the degradation products can play a role in local immune regulation, promoting angiogenesis and osteoblast migration, which synergizes with the bone regeneration effect of BMP-2, thereby significantly increasing the rate of new bone mineralization deposition.

[0049] In another embodiment of the invention, such as Figure 2As shown, the drugs in the multiple storage areas 1010 are all different, which can provide targeted drug support at different stages according to the actual needs of bone tissue repair and regeneration. This precision treatment strategy not only improves the therapeutic effect of drugs and reduces adverse drug reactions, but also accelerates the process of bone tissue repair and regeneration, and shortens the patient's recovery time.

[0050] For example, there are two separator membranes 12 to divide the drug release channel 101 into three storage regions 1010 with the spike tips facing the cover 11. The three storage regions 1010 are loaded with antibiotics, growth factor combined with growth factor and microvesicles, respectively. It can be understood that the growth factor (VEGF) combined with growth factor (BMP-2) is present in the same storage region, that is, both VEGF and BMP-2 are provided in the same storage region. The microvesicles can be exosomes.

[0051] Specifically, during the inflammatory phase of bone remodeling, local tissues will experience an inflammatory response. At this time, antibiotics in the lowest storage area 1010 are released first to avoid the risk of local infection and to inhibit the release of inflammatory mediators, reduce the degree of inflammatory response, and relieve patients' discomfort symptoms such as pain and swelling caused by inflammation, thus creating a favorable microenvironment for subsequent bone tissue repair.

[0052] As bone remodeling enters the proliferative phase, bone tissue begins to synthesize and proliferate in large quantities. At this time, VEGF and BMP-2 stored in another storage region 1010 are released. VEGF and BMP-2 synergistically promote vascularized bone formation.

[0053] As bone remodeling enters the remodeling phase, newly formed bone tissue needs further optimization of its structure and properties to restore normal physiological function. During this stage, exosomes in the third storage region 1010 begin to play a role. They regulate the balance of bone remodeling to cover the entire bone remodeling cycle (inflammatory phase-proliferative phase-remodeling phase), greatly improving treatment outcomes for patients.

[0054] It should be noted that the drug combination can be dynamically adjusted according to the patient's risk level. Patients at high risk of infection use a "dual antibiotic + antimicrobial peptide" regimen.

[0055] In one embodiment of the present invention, a nano-hydroxyapatite coating (not shown in the figure) is provided on the surface of the nail 10 adjacent to the cover 11. The coating thickness is 50-200 nm. The coating thickness can be set according to its own degradation time and the bone regeneration cycle, which is usually 6 months. By setting the thickness according to the bone regeneration cycle, it can ensure that the nano-hydroxyapatite coating degrades at an appropriate rate and releases beneficial components during the bone regeneration cycle, providing continuous and effective support for bone tissue regeneration and repair, thereby improving the treatment effect. The nano-hydroxyapatite coating can be applied to the surface of the nail 10 adjacent to the cover 11 by spraying.

[0056] In the above scheme, the nano-hydroxyapatite coating can promote osteoblast adhesion and calcium and phosphorus ion release.

[0057] In one embodiment of the present invention, such as Figure 1 As shown, the bone regeneration barrier component of this application also includes a collagen membrane 13 and a fixation member 14. The collagen membrane 13 is attached to the cover 11, and the fixation member 14 is used to fix the cover 11 and the collagen membrane 13 together to the nail body 10.

[0058] In the above scheme, the collagen membrane 13 on the covering 11 can form a barrier membrane that can block the soft tissue cells above, forming a physical barrier to prevent epithelial cells and connective tissue cells from growing into the bone regeneration area. The collagen membrane 13 can be selected from Gell-Hypernetted materials. Collagen membrane.

[0059] Furthermore, the fastener 14 in this embodiment can securely connect the cover 11, the collagen membrane 13 and the nail body 10 into a single integral component.

[0060] Compared to existing technologies, where the fixation and barrier functions of implants are separated, surgeons need to place different instruments multiple times during surgery to fix the implant and lay the barrier membrane. This not only increases the complexity and uncertainty of the surgery but also significantly prolongs the operation time. In contrast, this embodiment, with its integral component constructed using the fixation element 14, effectively simplifies the surgical procedure, avoids the need for multiple instrument placements, and thus significantly reduces the operation time, improves surgical efficiency, and lowers surgical risks.

[0061] It should be noted that the fastener 14 can be a screw, a spring clip, or other fastening component. For example, refer to... Figure 1 and Figure 4Taking the fixing member 14 as an example of a screw, a stepped hole 131 is opened on the collagen membrane 13, a light hole 111 is opened on the cover member 11, and an internal thread adapted to the external thread of the screw is provided in the drug release channel 101. The stepped hole 131, the light hole 111 and the drug release channel 101 are arranged coaxially and connected. Then, by threading one end of the screw through the stepped hole 131 and the light hole 111 into the drug release channel 101, the top of the screw is pressed into the stepped hole 131, thereby fixing the cover member 11 and the collagen membrane 13 together onto the nail body 10.

[0062] In one embodiment of the present invention, such as Figure 2 As shown, the cover 11 has multiple through holes 110. While ensuring the overall mechanical strength of the cover, the through holes 110 allow the passage of cells related to angiogenesis and bone regeneration and the transport of metabolic substances, thereby promoting blood supply.

[0063] Furthermore, such as Figure 3 As shown, the porosity of the through hole 110 on the cover 11 is 30-70%, and the pore diameter is 1-3mm. The above settings, within the range of porosity of 30-70% and pore diameter of 1-3mm, can satisfy the mechanical strength of the cover 11, effectively resist the pressure generated by the movement of muscles inside and outside the mouth, and also meet the needs of blood supply.

[0064] In summary, the design of the covering 11 achieves mechanical stress shielding, reducing pressure transmission to the osteoblast tolerance threshold. Furthermore, the covering 11 adapts to complex anatomical defect morphologies, ensuring the conformation of its edges to the contour of the bone defect area. Simultaneously, a controllable drug release system is established, maintaining drug concentration within an effective range throughout the bone regeneration cycle. Moreover, the surgical procedure is simplified, integrating fixation, barrier, and sustained-release functions. The synergistic achievement of these technical goals significantly improves the therapeutic effect of oral bone regeneration.

[0065] The preparation system for the bone regeneration barrier component as described in the first aspect above, according to a second aspect embodiment of the present invention, includes: a three-dimensional scanning module for acquiring morphological data of the bone defect area of ​​the patient, wherein the three-dimensional scanning module can use a 3Shape intraoral scanner to perform non-contact scanning of the bone defect area of ​​the patient's oral cavity, acquire surface morphological data of the dentition, gingiva and defect area, with a resolution of up to 50-100μm, accurately restore the details of soft tissue and tooth surface, and provide a basis for coronal morphological restoration.

[0066] Furthermore, in order to improve the accuracy of morphological data of bone defect areas in patients, CBCT can be used to obtain three-dimensional structural data of the jawbone, focusing on the location, depth, bone density, and distribution of surrounding nerves and blood vessels of the bone defect.

[0067] The data processing terminal communicates with the 3D scanning module, calculates the size and curvature parameters of the overlay 11 based on morphological data, and generates a 3D model. The data processing terminal can be a computer, tablet, or other terminal device. It can import intraoral scan surface data and CBCT bone tissue data into the same software (such as Mimics or 3ShapeDentalSystem), and achieve data fusion through registration technology (such as feature point or surface matching) to form a complete 3D anatomical model. Based on the fused 3D model, the "complete alveolar bone morphology" is restored. At the same time, based on the fused model, the 3D dimensions (such as length, width, and thickness) of the overlay 11 are determined to ensure close fit with the bone defect area (gap ≤ 100μm).

[0068] The curvature parameters of the bone defect edge and the surface of the covering 11 are extracted by software algorithms (such as Gaussian curvature and average curvature calculation) to ensure that the curvature of the component surface matches that of the bone surface, avoid stress concentration, and increase the matching degree between the covering 11 and the defect area in the patient's oral cavity, thereby reducing the bone powder loss rate. In addition, the internal structure is optimized by finite element analysis (such as the design of the through hole 110) to improve mechanical properties and bone ingrowth efficiency.

[0069] The 3D printing module communicates with the data processing terminal and manufactures the cover 11 based on the 3D model. The 3D printing module can be a 3D printer. In terms of printing technology, selective laser melting or electron beam melting is employed. These two technologies feature high precision and high resolution, enabling the accurate construction of complex structures in the cover 11. For the printing material, pure titanium is selected. Pure titanium has a high melting point and can withstand high temperatures during the 3D printing process without significant deformation, ensuring the dimensional accuracy and structural stability of the component. Simultaneously, it possesses good biocompatibility, preventing significant immune rejection after implantation, which is beneficial for the healing and repair of oral tissues. The 3D printing module is primarily used to print the cover 11 to achieve precise adaptation to the patient's oral cavity defect areas, minimizing bone powder leakage.

[0070] In one embodiment of the present invention, the preparation system further includes an electrospinning machine, a micro-extrusion 3D printer, a vacuum adsorption device, and a precision injection pump.

[0071] Advanced electrospinning technology was employed to prepare collagen membrane 13. By precisely controlling various parameters of the electrospinning machine, such as voltage, injection pump flow rate, and receiving distance, a collagen membrane 13 with a high specific surface area and porous structure could be prepared. This unique three-dimensional structure provides abundant adhesion sites for cells, which is conducive to cell adhesion, proliferation, and migration, thereby creating an ideal microenvironment for oral tissue regeneration and effectively promoting tissue repair and regeneration.

[0072] The septum 12 is formed using a micro-extrusion 3D printing process. The micro-extrusion 3D printer possesses high-precision printing capabilities, enabling precise control of the size and shape of the septum 12 based on a pre-set digital model, ensuring a perfect match with the drug release channels 101 inside the implant 10. The septum 12 is made of PLGA biomaterial, which has excellent biodegradability; its degradation rate can be precisely controlled by adjusting key parameters such as molecular weight and copolymer ratio. This characteristic allows the septum 12 to achieve gradient drug release according to drug release requirements, providing continuous and controllable drug support for dental implant treatment.

[0073] In the fixing process of the diaphragm 12, a combination of vacuum adsorption and solvent-assisted bonding is used. The vacuum adsorption device generates a strong negative pressure, causing the diaphragm 12 to adhere tightly to the inner wall of the drug release channel 101, forming an initial mechanical fixation. Subsequently, acetone impregnation is used to form a chemical bond between the diaphragm 12 and the inner wall of the channel, further enhancing the adhesion. After rigorous testing, this fixing method ensures that the diaphragm 12 remains stable during use, without displacement or detachment, thus guaranteeing the normal operation of the drug release system.

[0074] The screw body 10 is made of prefabricated components, and its specific specifications can be customized according to clinical needs. For example, in this embodiment, the screw body 10 has a diameter of 3 mm, a length of 10 mm, a surface thread depth of 0.3 mm, and a thread pitch of 0.8 mm. This design provides good initial stability and ensures that the implant is tightly integrated with the bone tissue. The screw body 10 has a drug release channel 101 inside, with a diameter of 0.7 mm and a length of 5 mm, providing ample space for drug storage and release.

[0075] Medication is administered using a precision infusion pump for zoned irrigation. This pump features high-precision flow control and injection speed adjustment, enabling accurate and quantitative injection of different medications into corresponding areas of the nail body 10 according to a preset program, achieving zoned storage and gradient release of the medication. This zoned irrigation method provides personalized medication treatment plans based on different stages and needs of oral tissue repair, improving treatment outcomes.

[0076] Specifically, the septum 12 and the drug injection can be pre-placed in the implant body 10, making the implant body 10 an independent drug storage implant structure. This design allows for subsequent use by only assembling the cover 11 and collagen membrane 13, greatly simplifying the surgical procedure, shortening the operation time, and reducing surgical risks.

[0077] Finally, the cover 11, collagen membrane 13, and nail body 10 with separator membrane 12 are assembled and fixed in sequence using the fastener 14, which can ensure that the connection between each component is firm and reliable, forming a complete bone regeneration barrier component.

[0078] The implantation method of the bone regeneration barrier component described in the first aspect of the present invention, as per the third aspect embodiment, comprises the following specific steps:

[0079] (1) Surgical area preparation: First, perform full-thickness flap flap operation to fully expose the bone defect area, carefully and thoroughly remove the granulation tissue in the area, and then use ultrasonic bone scalpel to finely trim the bone surface to create good conditions for subsequent operations.

[0080] (2) Nail insertion: The insertion point is precisely located with the help of a digital guide plate. Drilling is carried out under the guidance of the guide plate. First, a positioning drill and a 2.0 mm diameter pilot drill are used to prepare the insertion site of the nail body 10. Then, the nail body 10 is inserted to ensure that it obtains sufficient initial stability.

[0081] (3) Assembly operation: Place the cover 11 and collagen membrane 13 in the appropriate position and carefully adjust their position to ensure good fit with the surrounding tissue. Then use the fixation piece 14 to firmly fix the collagen membrane 13 and cover 11 to the nail body 10 to ensure the structural stability of the entire bone regeneration system.

[0082] (4) Implantation of bone repair material: The area below the cover 11 and around the nail body 10 is filled with bone repair material (bone powder) evenly and fully. During the filling process, it should be carried out in an orderly manner from the root of the nail body 10 toward the coronal direction to provide a suitable environment for bone tissue regeneration and repair.

[0083] (5) Suturing: Determine whether soft tissue tension-reducing surgery is necessary based on the patient's specific clinical needs. If so, perform the procedure according to standard operating procedures. Finally, use mattress sutures to ensure the wound closes tightly without tension, promoting wound healing.

[0084] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0085] The above description is merely a specific embodiment of the present invention, enabling those skilled in the art to understand or implement the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments described herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A bone regeneration barrier component, characterized in that, include: The nail body has self-tapping threads on its surface; A cover, detachably attached to the nail body, the size and shape of which are adapted to the shape of the defect area in the patient's oral cavity; The nail body has a drug release channel inside, and the drug release channel is filled with drug. The outer wall of the nail body is provided with multiple micropores, which are connected to the outside and the drug release channel to release the drug.

2. The bone regeneration barrier component according to claim 1, characterized in that, The drug release channel is provided with at least one degradable separator membrane to divide the drug release channel into multiple storage areas, wherein multiple micropores are located in one of the storage areas adjacent to the tip of the nail body.

3. The bone regeneration barrier component according to claim 2, characterized in that, The drugs in the multiple storage regions are the same, wherein the drugs may be growth factors.

4. The bone regeneration barrier component according to claim 2, characterized in that, The drugs in the various storage areas are not the same.

5. The bone regeneration barrier component according to claim 4, characterized in that, There are two separator membranes to divide the drug release channel into three storage areas, with the spikes pointing towards the cover. The three storage areas are loaded with antibiotics, growth factors, and microvesicles, respectively.

6. The bone regeneration barrier component according to claim 1, characterized in that, The surface of the nail body adjacent to the cover is provided with a nano-hydroxyapatite coating with a thickness of 50-200 nm.

7. The bone regeneration barrier component according to claim 1, characterized in that, It also includes a collagen membrane and a fixing element, wherein the collagen membrane is adhered to the cover and the fixing element is used to fix the cover and the collagen membrane together to the nail body.

8. The bone regeneration barrier component according to claim 7, characterized in that, The cover has multiple through holes.

9. The bone regeneration barrier component according to claim 8, characterized in that, The porosity of the through holes on the cover is 30-70%, and the pore diameter is 1-3 mm.

10. A system for preparing a bone regeneration barrier component as described in any one of claims 1-9, characterized in that, include: The 3D scanning module is used to acquire morphological data of the patient's bone defect area; The data processing terminal is communicatively connected to the three-dimensional scanning module, calculates the size and curvature parameters of the cover based on the morphological data, and generates a three-dimensional model. The 3D printing module is communicatively connected to the data processing terminal and manufactures the cover according to the 3D model.

Images