Bone implant device based on 3D dispensing and high-precision selective coating with functional coating

Abstract

The application discloses a bone implant device with a functional coating based on 3D dispensing and high-precision selective coating, and specifically relates to the following: 1) based on 3D scanning and modeling technology, a titanium-based bone implant device is digitally reconstructed, and in combination with finite element simulation analysis of the surface stress of the device in a service state, a stress concentration area is demarcated as a non-coating area; 2) after pretreatment of the device base, panoramic visual 3D dispensing of high-temperature-resistant UV curing glue, gradual photocuring shaping and baking operations are performed on the non-coating area to form stable shielding; 3) through mixed plasma cleaning, vapor deposition and / or electrochemical deposition technology, high-bonding-strength selective deposition of the functional coating is realized on the non-shielding area; 4) after glue removal, cleaning, drying, packaging and irradiation sterilization treatment, the finished product is obtained. The application fundamentally overturns the traditional local plating implementation paradigm of metal coating, and has the remarkable advantages of high operation efficiency, convenient process and low cost.

Description

Technical Field

[0001] This invention belongs to the field of antibacterial medical device manufacturing technology, specifically relating to a bone implant device based on 3D dispensing and high-precision selective coating of a functional coating. Background Technology

[0002] Titanium and titanium alloys have become one of the preferred matrix materials for orthopedic implants due to their excellent mechanical properties, corrosion resistance, and good biocompatibility. However, in clinical applications, traditional titanium alloy bone implants themselves lack bioactivity. Nevertheless, clinical pain points such as slow fracture healing and high postoperative infection rates have made achieving osseointegration and antibacterial function a major research direction for second-generation bone implants. Currently, several products are under development for antibacterial coatings containing metal ions such as silver, copper, and zinc, as well as osteogenic coatings containing calcium phosphorus, bioactive glass, or growth factors. However, these functional coatings generally suffer from inherent defects such as softness, insufficient bonding strength with the titanium matrix, and poor resistance to friction and wear. In real mechanical environments, the coating is prone to peeling or damage due to bone micromovement, relative friction between the implant and bone interface, and implant insertion, leading to functional failure or even local foreign body reactions. Therefore, although second-generation functional coated titanium-based bone implants are on the horizon, overcoming the practical technical challenges of coating wear and detachment remains a significant challenge in actual clinical applications.

[0003] There are two main approaches to addressing the aforementioned technical problems: enhancing the coating and removing the coating altogether. Since safety is paramount for medical devices, introducing other elements to enhance the coating introduces more uncontrollable factors and may require more testing and verification during registration and certification, significantly increasing the difficulty and time required for the process. Therefore, the ideal solution is not to coat the entire device surface, but rather to achieve selective coating. This involves depositing the coating in functional areas requiring osseointegration or antibacterial properties, while leaving the uncoated titanium alloy substrate in stress concentration areas, elastic deformation areas, or high-friction interfaces, fully utilizing its excellent mechanical properties and wear resistance. However, high-precision selective coating relies on reliable local masking techniques. Traditional physical masking methods (such as tape, sheaths, etc.) have limited accuracy and poor thermal stability and chemical resistance. While 3D-printed custom sleeves, which have emerged in recent years, have improved the fit to some extent, they still cannot avoid micro-gaps between the sleeve and the instrument surface. They are prone to plating in high-temperature, chemical deposition, or electrolyte environments. Furthermore, the sleeves are handled manually, and they are not well sealed for complex structures such as porous or grooved structures, making it difficult to guarantee the reliability of shielding.

[0004] Another approach is "full coating first, then local removal," which involves depositing a coating on the entire surface of the instrument and then selectively removing the coating from specific areas using methods such as laser etching, chemical etching, or mechanical processing. However, this method faces numerous practical challenges: the heat-affected zone of laser etching is prone to microcracks, oxidation, or phase transformation at the coating edges, affecting the integrity of the substrate; chemical etching is difficult to precisely control the boundaries, easily resulting in incomplete etching or over-etching, and the etching solution may damage the titanium substrate and generate harmful waste; mechanical removal is poorly operable for complex curved surfaces and microstructures, easily causing scratches or dimensional deviations. Furthermore, the process of removing metal coatings poses a risk of damage to temporary protective tooling such as silicone sheaths and polymer shielding layers, easily leading to edge defects. Overall, the post-removal method has a long process chain, is difficult to control with precision, and is costly, making it particularly unsuitable for the selective control requirements of internal cavities, grooves, and irregular curved surfaces in mass production.

[0005] To address the aforementioned technical bottlenecks, this invention proposes a high-precision selective coating method for titanium-based bone implants based on automated precision dispensing. This method integrates finite element analysis, panoramic vision 3D dispensing technology, specialized masking adhesives, and deposition after film removal and activation. It can automatically extract stress zoning boundaries based on mechanical analysis, delineating the contours of uncoated areas with high stress concentrations and low-stress areas to be coated. This effectively solves the problem of inaccurate traditional empirical definitions, achieving precise and stable masking of any area of ​​complex orthopedic instruments with complex curved surfaces, micropores, irregular edges, and deep cavities. It is adaptable to harsh environments such as subsequent high-temperature coating deposition, effectively avoiding coating defects caused by adhesive shrinkage, creep, or localized detachment. This method provides a high-precision, high-reliability, high-efficiency, and broad-spectrum systemic solution for the precise selective coating of titanium-based bone implants, meeting the requirements of green manufacturing, and is particularly suitable for mass production. Summary of the Invention

[0006] The purpose of this invention is to address the shortcomings of existing technologies by providing a bone implant device based on 3D dispensing and high-precision selective coating of a functional coating. By directly setting high-stress concentration areas as uncoated areas and using 3D dispensing for high-precision selective masking, this invention effectively solves the problems of easy wear and detachment of coated bone implant devices and the difficulty in ensuring the reliability of traditional masking techniques for complex and irregularly shaped devices. This invention can solve the problem of easy coating detachment at its root. The entire process is adaptable to the complex and irregular structures of titanium-based bone implant devices, has a high degree of automation, and is suitable for the large-scale production and widespread application of medical implants.

[0007] This invention is achieved using the following technical solution: A bone implant device based on 3D dispensing and high-precision selective coating of functional coatings is provided, which divides the surface of the titanium-based bone implant device into high-stress areas and low-stress areas. The high-stress area is the stress concentration area where the stress exceeds a preset threshold in the service condition simulation of the instrument. The surface of the high-stress area is exposed and no functional coating is provided. The low-stress region is the region in which the stress of the instrument does not exceed a preset threshold during service condition simulation, and the surface of the low-stress region is covered with a functional coating. The boundary of the functional coating matches the boundary of the high-stress region and the low-stress region, and the boundary of the functional coating is precisely defined by a 3D dispensing process.

[0008] The preparation method of the above-mentioned bone implant device specifically includes the following steps: 1) Based on 3D scanning, the titanium-based bone implant device to be coated is digitally reconstructed in three dimensions. Combined with finite element simulation analysis of the surface stress distribution under the service state of the device, the high-stress uncoated area with stress higher than the preset threshold and the low-stress coated area with stress not higher than the preset threshold are divided to obtain a stress partitioning model. 2) After degreasing the instrument substrate, apply high-temperature UV-curable adhesive to the uncoated area using panoramic 3D dispensing, progressive light curing and baking to form a stable masking layer. The masking layer completely covers the high-stress uncoated area and its boundary, or extends further outward to the boundary to retain a safety margin. 3) After performing dual membrane removal on the obtained sample, a functional coating is deposited on the instrument surface using vapor deposition and / or electrochemical deposition techniques; the dual membrane removal includes a first-stage weak acid immersion membrane removal and a second-stage mixed plasma membrane removal and activation. 4) After removing the adhesive from the shielding layer, clean, dry, and sterilize by irradiation to obtain the finished bone implant device.

[0009] In the above technical solution, further, in step 1), after completing the three-dimensional modeling of the titanium-based bone implant device, the mechanical state of the device under actual use conditions is simulated. The yield strength of the device substrate is used as the stress threshold to divide the high-stress uncoated area and the low-stress coated area. During the finite element analysis, the mesh of the hole and corner area is refined, and the stress distribution on the surface of the device substrate is solved separately. The stress concentration location is located based on the Mises equivalent stress cloud map.

[0010] Furthermore, the high-temperature UV-curable adhesive described in step 2) has a temperature resistance of not less than 130℃, is resistant to acids and alkalis, and has a linear shrinkage rate ≤0.5%. Using this high-temperature UV-curable adhesive allows it to maintain peelability from the titanium-based substrate after subsequent coating preparation processes (such as the high-temperature environment of vapor deposition). This effectively solves the problem that many adhesives, although resistant to high temperatures, cannot peel well from the substrate after curing and undergoing the high temperature of vapor deposition; 3D The dispensing process employs a two-stage operation: The first stage is high-precision edge dispensing, using a needle with an inner diameter of 60-100μm. Dispensing is done along the boundary of the uncoated area or by moving the needle outwards, with an air pressure of 0.05-0.15MPa and a speed of 5-10mm / s. After tracing, UV pre-curing is performed for 2-5 seconds to lock the edge and set the shape. The second stage is supplementary dispensing, using a needle with an inner diameter of 150-300μm to perform a filling dispensing operation within the locked boundary of the uncoated area, with an air pressure of 0.15-0.40MPa and a speed of 10-20mm / s. The filling density and adhesive thickness are adjusted according to the shape of the instrument. After dispensing, the entire area is UV-cured and then baked at 100-150℃ for 20-40 minutes.

[0011] Furthermore, in step 2), panoramic 3D vision is used to obtain a three-dimensional point cloud of the instrument surface. The three-dimensional point cloud is registered with the stress zoning model obtained in step 1), and the root mean square error of the registration is controlled to be ≤0.05mm. The uncoated area on the stress zoning model is expanded outward by a safety margin of 0.1-0.3mm to form a theoretical boundary, which is then mapped onto the instrument's three-dimensional point cloud as the target area that needs to be coated with adhesive. Based on the defined target area for adhesive application, a dispensing path is generated and optimized, including the boundary tracing path and the internal filling path. During the boundary tracing dispensing process, position data is collected in real time and three-axis dynamic deviation compensation is performed to control the deviation between the adhesive line landing point of the target area boundary and the theoretical boundary to not exceed ±25μm.

[0012] Furthermore, step 3) involves immersing the sample in a weak acid stripping solution to remove the membrane. The stripping solution contains 50-80 g / L citric acid, 10-30 g / L ammonium fluoride, 1-5 g / L imidazole, and the remainder is deionized water. The dual-hybrid plasma film removal activation involves placing the sample in a vacuum chamber and evacuating it to a vacuum level better than 5 × 10⁻⁶. -3For in-situ heating and desorption of water vapor, argon and hydrogen are introduced at a volume ratio of 1:1-10:1, and the working pressure is adjusted to 1.5-8 Pa. An RF power supply is applied to the electrodes with an excitation power of 100-300 W, and a negative bias voltage of -50 to -100 V is applied to the sample to generate mixed plasma for cleaning. Hydrogen gas intake is stopped, while maintaining the argon flow rate and plasma excitation state. The RF power is increased to 200-400 W, and the negative bias voltage is increased to -100 to -200 V, utilizing high-energy Ar... + The sample is subjected to secondary bombardment with ions to remove the film and activate it.

[0013] Furthermore, the functional coating includes an antibacterial coating formed from one or more of gold, platinum, palladium, zinc, silver, and copper.

[0014] Furthermore, the adhesive removal in step 4) includes: removing adhesive from the masking layer located on the outer surface of the instrument using a force-controlled semi-automatic peeling process, and removing adhesive from the masking layer located in the instrument's holes, grooves, or tubular structures using a steel needle piercing and unscrewing method.

[0015] Furthermore, for the removal of the adhesive layer on the outer surface of the instrument, a semi-automatic force-controlled peeling process using a robotic arm is employed. This process includes: installing a gripper at the end of the robotic arm, with a torque sensor between them; using a contour-following multi-point flexible fixture to fix the instrument; utilizing the fluorescent properties of UV adhesive combined with a vision system to identify the adhesive layer; selecting the peeling starting point based on the curvature of the adhesive layer; and controlling the robotic arm to execute a pre-planned peeling path. During the peeling process, an ion curtain is activated to eliminate static electricity. Simultaneously, the torque sensor collects the peeling resistance torque in real time. Combining the reference torque and the vision system, four conditions are automatically determined: normal peeling, adhesive layer adhesion, adhesive layer breakage, and peeling completion. The peeling starting point is preferentially selected when the curvature is greater than 0.2 mm. -1 The maximum point.

[0016] Furthermore, for the internal adhesive layer of instrument holes, grooves, and tubular structures, a steel needle puncture and unscrewing method is used to remove it. The hole position is located by visual algorithm, and 2-6 steel needles with a diameter of less than 0.8mm are inserted into the shielding layer inside the hole. The reaction force is monitored in real time during the puncture process. The clamping mechanism of each steel needle rotates in the same direction at a speed of 0.5-2r / s, while the tooling retracts along the hole axis at a speed of 2-5mm / s, forming a combined unscrewing and pulling motion to complete the adhesive removal.

[0017] Compared with the prior art, the present invention has the following advantages: 1) This invention uses titanium / titanium alloy bone implants as a substrate and innovatively employs a digital stress zoning method based on 3D scanning and finite element simulation, a panoramic vision 3D dispensing process, a high-temperature resistant UV-curable adhesive masking material, and a hybrid plasma secondary film removal process, or further combined with a force-controlled semi-automatic peeling process. Through this unique combination of processes, it successfully achieves precise and selective deposition of functional coatings. In this invention, high-stress concentration areas are defined as uncoated areas for masking based on interfacial contact stress; the stress zoning is automatically planned after 3D registration with the actual device; a high-precision masking layer is constructed using two-stage dispensing of edge tracing and zoning filling; and argon-hydrogen mixed plasma cleaning and high-energy Ar... + The complete process chain of ion bombardment synergistic activation of unmasked areas, and further real-time monitoring of force-controlled grippers continuously tearing off adhesive layers, is proposed for the first time in this invention and applied in the field.

[0018] 2) The precision selective coating method in this invention features a unique process chain design: digital stress zoning, panoramic visual 3D dispensing masking, hybrid plasma secondary film removal, vapor phase deposition / electrochemical deposition coating, or further combined with semi-automated force-controlled peeling, which can synergistically meet the full-process requirements of high-precision selective masking, high tolerance of the masking layer, efficient activation of unmasked areas, and non-destructive removal of the masking layer. Among these: ① The digital stress zoning method based on finite element simulation takes the interface contact stress as the core load input, eliminates the interference of non-contact components such as the torque and bending moment of the instrument body, and quantitatively defines the high stress concentration area as the uncoated masking area. This solves the problem that traditional processes rely on experience judgment and lack quantitative mechanical basis, so that the subsequent masking layer can accurately cover the stress-sensitive area that needs to be protected. In addition, the edge trajectory in the staged dispensing strategy prioritizes covering the high stress zoning boundary, further enhancing the masking reliability of the key area. ② By using panoramic vision 3D dispensing technology, the physical object and digital partition model are accurately registered. Combined with a two-stage dispensing process and the selected UV curing adhesive, a masking layer with precise contours is formed. It has excellent chemical and thermal stability and can easily cope with the high-temperature environment of subsequent plasma cleaning and vapor deposition, as well as the highly corrosive medium of electrochemical deposition. This ensures that the masking layer does not deform, peel off, or decompose. The masked area has clear boundaries and no plating defects throughout the entire coating deposition process. This tolerance is not available in traditional masking materials such as tapes and sheaths. It effectively ensures the boundary accuracy between the coated and uncoated areas (the boundary accuracy of the finished coating reaches the micron level). At the same time, it is this masking adhesive layer that connects the front-end stress zoning planning and the back-end coating deposition selection control, realizing the organic unity of digital design and physical masking. ③ In the hybrid plasma secondary film removal process, argon-hydrogen mixed plasma cleaning and high-energy Ar plasma are used. +The ion bombardment synergistic treatment effectively removes the oxide layer and adsorbents in the unmasked area, while achieving the dual goals of cleaning and activating the unmasked area and protecting it by virtue of the excellent chemical resistance of the masking adhesive layer. This avoids the risk of corrosion to the adhesive layer and the substrate caused by the traditional wet soaking process, and also ensures the peelability of the subsequent masking layer. ④ In the semi-automatic peeling process, the force-controlled flexible gripper, in conjunction with the series torque sensor, monitors the peeling force in real time. The adhesive layer is continuously peeled off along the contour of the instrument at a constant peeling angle and speed, which can achieve efficient and non-destructive batch removal of the masking layer. It can also be further combined with automatic optical inspection and plasma cleaning to replace manual wiping, significantly improving industrial production efficiency and product consistency.

[0019] This invention, for the first time, addresses the practical needs of precision selective deposition for bone implants. It organically integrates the aforementioned processes, focusing on masking accuracy, masking material tolerance, green film removal, and efficient demasking, achieving full automation of the precision selective coating process. The selective coating method of this invention simultaneously possesses high masking accuracy, excellent masking layer tolerance, efficient activation capability of unmasked areas, and non-destructive peelability. It effectively meets the comprehensive requirements of precision selective coating for bone implants in terms of accuracy, reliability, and efficiency, providing an innovative solution for the surface functionalization of orthopedic (or dental, etc.) implants.

[0020] 3) This invention fundamentally overturns the traditional paradigm of localized metal coating. It replaces empirical area division with digital stress zoning, manual application of masking with panoramic 3D dispensing, strong acid wet film removal with ammonium bifluoride as a weak acid system in the double film removal process, activates unmasked areas with hybrid plasma dry cleaning, and replaces manual peeling and wiping with force-controlled semi-automatic peeling. This achieves a paradigm shift from "experience-driven, primarily manual" to "data-driven, automatically coordinated." Crucially, this invention overcomes the technical bottleneck of traditional masking materials failing easily in high-temperature coating processes, enabling precise selective deposition to cover various high-temperature coating processes such as vapor deposition, significantly expanding the applicability of the process. The entire process chain requires only five core steps: 3D scanning and modeling, dispensing and curing, weak acid film removal and plasma cleaning, coating deposition and automated peeling. It is highly efficient and convenient to operate. Furthermore, the masking adhesive can be dispensed and cured in batches, and plasma cleaning and force-controlled peeling can be completed online continuously, enabling large-scale production. This significantly reduces labor and time costs and has outstanding advantages for industrial applications. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the preparation process of the functional coating on the bone implant device in this invention; Figure 2To combine the stress concentration analysis results of the bone implant device in Example 1 with finite element simulation technology (considering the similarity of the working conditions of the holes on the bone plate during use, one hole is selected as an example for simulation analysis); Figure 3 This is a physical image of the object after 3D dispensing in Embodiment 1 of the present invention (taking a bone plate as an example). Figure 4 This is a photograph of the sample after PVD silver plating following adhesive application in Example 1 (taking a bone plate as an example, the plating type is silver). Figure 5 The image shows a physical picture of the bone implantation device based on 3D dispensing and high-precision selective coating of functional coating obtained by the present invention in Example 1 (taking a bone plate as an example, the plating is silver). Figure 6 The image shown is of a bone implant device (using a screw as an example, with copper plating) prepared according to the present invention in Example 2, which is based on 3D dispensing and high-precision selective coating of a functional coating. Figure 7 To achieve the antibacterial effect of locally coated medical metal functional coating using the method of the present invention (taking locally coated screws as an example, the third from the left corresponds to TC4 (uncoated), and the third from the right corresponds to Example 2); Figure 8 To achieve bone integration results using the method of this invention with locally coated medical metal functional coatings (taking screws as an example, combined with a rabbit intramedullary infection model, the coating seed is copper, the left figure corresponds to TC4 (uncoated), and the right figure corresponds to Example 2); Figure 9 This is a schematic diagram of the finite element simulation analysis process of the screw being screwed into the bone in Example 2. Detailed Implementation

[0022] The technical solution of the present invention will be further described below with reference to the accompanying drawings and specific embodiments. The bone implant device based on 3D dispensing and high-precision selective coating of functional coatings provided by the present invention, such as… Figure 1 As shown, its preparation method includes the following: 1) Based on 3D scanning, the titanium-based bone implant device to be coated is digitally reconstructed in three dimensions. Combined with finite element simulation analysis of the surface stress distribution under the service state of the device, the high-stress uncoated area with stress higher than the preset threshold and the low-stress coated area with stress not higher than the preset threshold are divided to obtain a stress partitioning model. 2) After degreasing the instrument substrate, apply high-temperature UV-curable adhesive to the uncoated area using panoramic 3D dispensing, progressive light curing and baking to form a stable masking layer. The masking layer completely covers the high-stress uncoated area and its boundary, or extends further outward to the boundary to retain a safety margin. 3) After performing dual membrane removal on the obtained sample, a functional coating is deposited on the instrument surface using vapor deposition and / or electrochemical deposition techniques; the dual membrane removal includes a first immersion membrane removal and a second hybrid plasma membrane removal and activation. 4) After removing the adhesive from the shielding layer, clean, dry, and sterilize by irradiation to obtain the finished bone implant device.

[0023] In some embodiments of the present invention, the bone implantation device refers to titanium-based bone plates, bone screws, intramedullary nails, human joint prostheses, spinal connectors, interbody fusion devices, dental implants, etc.

[0024] In some embodiments of the present invention, the functional coating typically includes an antimicrobial coating formed from one or more of gold, platinum, palladium, zinc, silver, and copper.

[0025] In some embodiments of the present invention, step 1) uses blue structured light for three-dimensional scanning and modeling, with a single frame accuracy of 0.01-0.03 mm and an overall error of ≤0.05 mm; then the model is imported into finite element analysis software for stress analysis.

[0026] In some embodiments of the present invention, when performing finite element analysis, the parameters of the device substrate are set according to the service conditions of the bone implant device, including the elastic modulus, Poisson's ratio, tensile strength, etc. of the substrate. The device-device and device-bone interfaces that may be subjected to stress are defined to simulate the actual use conditions, perform stress analysis, and obtain the Mises equivalent stress cloud map and the location of local stress concentration. A threshold is set based on the material yield strength, and the stress concentration area exceeding the threshold is defined as the uncoated area, and the area below the threshold is defined as the non-masked coated area, thus completing the coating zoning.

[0027] In some embodiments of the present invention, during finite element analysis, the global mesh size is 0.1-0.5 mm, and the mesh size for holes and corner areas is refined to 0.05-0.1 mm. Finite element simulation is performed with the contact stress at the interface between the device and the shielding layer as the core load input, excluding non-contact mechanical components such as torque and bending moment borne by the device body during service, and solving the stress distribution at the coating interface under external forces such as peeling force, pressure, and friction force separately.

[0028] In some embodiments of the present invention, 65-80% of the material yield strength can be used as a threshold, and the stress concentration area exceeding the threshold can be defined as an uncoated area, while the area below the threshold can be defined as an unmasked coated area.

[0029] In some embodiments of the present invention, the degreasing method in step 2) is as follows: Prepare a solution containing 20-30 g / L sodium hydroxide, 8-16 g / L sodium carbonate, 10-15 g / L sodium metasilicate pentahydrate, 3-5 g / L fatty alcohol polyoxyethylene ether, 2-5 g / L sodium citrate, 1-4 g / L sodium polyacrylate, and 0.5-1 g / L benzotriazole, with the remainder being deionized water; immerse the instrument in the solution, use ultrasonic degreasing power of 100-180 W, solution temperature of 50-60°C, and immersion time of 20-30 min; after degreasing, rinse multiple times with deionized water.

[0030] In some embodiments of the present invention, the panoramic visual 3D dispensing includes: (a) Spatial registration: The partition model (also known as the partition drawing) obtained in step 1) is imported into the automatic dispensing machine. A four-eye industrial camera is used in conjunction with a laser line scanner to perform a full-area scan of the actual instrument to obtain a three-dimensional point cloud model of the actual surface. Coarse registration based on Fast Point Feature Histogram (FPFH) and fine registration based on Iterative Closest Point (ICP) are used to align the actual point cloud with the partition drawing model to a root mean square error of ≤0.05mm to correct clamping deviation. (b) Automatic area definition: Based on the registered model, the region growth segmentation algorithm based on the difference of normal vectors is adopted. The threshold of the included angle of the normal vector is set to 15° and the curvature threshold is set to 0.05. The safety margin of 0.1-0.3mm is extended outward along the partition boundary (uncoated area) in the drawing. The uncoated area is automatically defined on the physical object and mapped to the target area that needs to be coated. (c) Path generation and optimization: Based on the boundary of the target area, the boundary tracing path is generated by edge contour discretization (discrete spacing ≤ 0.1 mm, and sharp corners are automatically inserted with arc transitions). The internal filling path is generated by the Offset Contour Parallel Fill (OCP) algorithm (fill spacing 150-250 μm). Curve fitting based on moving least squares method is used for smooth optimization to eliminate curvature abrupt changes. (d) Dynamic compensation: During the dispensing process, laser line scan feedback is collected in real time at a frequency of 50-100Hz and compared with the drawing model. The three-dimensional deviation vector is calculated by a proportional-integral-derivative (PID) controller to perform dynamic closed-loop correction of the XYZ axes, ensuring that the deviation between the glue line landing point and the theoretical boundary does not exceed ±25μm.

[0031] In some embodiments of the present invention, photocurable adhesives with high temperature resistance (above 130°C), acid and alkali resistance, peelability, and linear shrinkage rate ≤0.5% (ISO 3521) such as HumiSeal UV92, Dymax SpeedMask® series, ETOP-BOND KB-11, MSK HPF10-B, U320-P119, ZJ-EP510, DH-1038, ZJ-EPAF323, and CRCBONDUV4069 are selected. The above selection is based on the systematic verification of the masking material's resistance to high temperature baking, plasma cleaning, high temperature environment of vapor deposition, and acid and alkali media of electrochemical deposition. It also takes into account the problem of balancing the resistance and peelability of the adhesive layer encountered in the actual process development: if conventional photoresist or thermosetting adhesive is selected, carbonization, cracking or decomposition may easily occur in the high temperature environment of vapor deposition or the highly corrosive environment of electroplating tank, resulting in masking failure; while if only high resistance is pursued, the adhesive layer is easy to break and remain during peeling, increasing the burden of subsequent cleaning. The adhesive selected in this invention shrinks to its final size in one step after UV exposure and high-temperature baking, achieving both dimensional stability under high temperature and strong corrosion environments and continuous, intact peeling performance. Although such adhesives have been reported in fields such as electronic packaging, this invention addresses the actual needs of selective coating of bone implant devices involving harsh conditions such as vapor deposition and electrochemical deposition. Through compatibility testing and process parameter optimization, it achieves the first-ever adaptation and innovative use of the aforementioned material in this application scenario.

[0032] In some embodiments of the present invention, the 3D dispensing process employs a two-stage operation: the first stage is high-precision edge dispensing, using an L-shaped curved precision injection needle with an inner diameter of 60-100μm to perform outlining dispensing along the boundary of the uncoated area, with an air pressure of 0.05-0.15MPa, a speed of 5-10mm / s, and the glue line width controlled at 80-120μm to ensure the integrity and continuity of the boundary glue line. After outlining, the edge is immediately pre-cured with a UV-LED point light source or line light source for 2-5 seconds to lock and shape the edge; the second stage is supplementary dispensing, using a straight needle with an inner diameter of 150-300μm, operating within the uncoated area with the locked boundary, with an air pressure of 0.15-0.40. MPa, speed 10-20mm / s, adjust filling density and glue thickness according to the shape of the instrument surface. Depending on the shape and structure of the bone implant instrument, glue application can generally be divided into two scenarios: First, surface glue (such as masking the outer surface of instruments like metal bone needles), aiming to form a continuous, uniform, peelable glue film. The typical controllable range for the total glue layer thickness is 500-3000μm, with the specific thickness flexibly set according to the peeling process and instrument tolerances. Second, glue application within pores / tubes (such as filling holes and tubular structures that need to be masked, like bone plate screw holes). This requires the glue to completely fill the pore / tube structure, with the glue layer flush with the surface of the pore / tube structure, and no air bubbles or depressions inside. After the glue application step, it is first exposed to a UV-LED surface light source (wavelength 365-405nm, irradiance 50-200mW / cm²). 2 Expose the entire layer for 1-15 minutes to allow the adhesive layer to fully cure and shrink in one go; then bake at 100-150℃ for 20-40 minutes to fully release internal stress and ensure dimensional stability of the adhesive layer after heat setting; finally cool to room temperature and perform visual quality inspection, focusing on checking the coating integrity of the uncoated areas and the accuracy of the adhesive layer boundaries.

[0033] In some embodiments of the present invention, the first immersion membrane removal involves placing the masked sample in a stripping aqueous solution containing 50-80 g / L citric acid, 10-30 g / L ammonium bifluoride, and 1-5 g / L imidazole, and immersing it at room temperature for 100-200 seconds to achieve the first membrane removal. After the first membrane removal, the sample is rinsed multiple times with deionized water and dried with nitrogen. This first membrane removal avoids the defects of traditional strong acid membrane removal and can effectively protect the masking layer.

[0034] In some embodiments of the present invention, the dual hybrid plasma film removal activation involves placing the sample in a vacuum drying oven to complete the drying process, cooling it to room temperature, and then transferring it to a vacuum chamber where a background vacuum of better than 5 × 10⁻⁶ is evacuated. -3The water vapor is desorbed by in-situ heating at 100-170℃; a mixture of high-purity argon and high-purity hydrogen is introduced, controlling the volume ratio of argon to hydrogen to be 1:1-10:1, and the working pressure is adjusted to 1.5-8 Pa; an RF power supply is applied to the electrode with an excitation power of 100-300 W, and a negative bias voltage of -50 to -100 V is applied to the sample to generate mixed plasma, which is continuously cleaned for 10-30 min; after cleaning, the hydrogen gas supply is stopped, the argon flow rate and plasma excitation state are maintained, the RF power is increased to 200-400 W, and the negative bias voltage is increased to -100 to -200 V, using high-energy Ar... + Ions bombard the unmasked areas a second time to remove the film, for 5-15 minutes. This invention innovatively employs a hybrid plasma secondary film removal process to clean and activate the unmasked areas after the adhesive dispensing and masking are completed, in order to achieve selective deposition of the composite metal coating with high bonding strength in the unmasked areas. Unlike traditional methods that treat homogeneous substrates, this invention performs selective activation treatment on the unmasked areas under the premise of an existing UV-curable adhesive masking layer, achieving differentiated treatment of heterogeneous surfaces with masking layers. Furthermore, parameters such as the argon-hydrogen volume ratio, RF power, negative bias voltage, and processing time in the aforementioned plasma process all affect the integrity of the masking adhesive layer and the activation effect of the unmasked areas; improper parameters will lead to adhesive layer damage or insufficient activation.

[0035] In some embodiments of the present invention, the vapor deposition process is as follows: the vapor deposition method is one of PVD, CVD, PECVD, ALD, etc.; the metal is one of gold, platinum, palladium, zinc, silver, copper, etc. Wherein: When depositing gold in the vapor phase, PVD, CVD, PECVD, ALD, etc. can be used. If PVD is preferred, the specific process parameters are as follows: move the equipment into the vacuum chamber and evacuate to 5×10⁻⁶. -4 Heat to 100-200℃, rotate the rack at 10-20 r / min, inject 50-90 sccm of argon gas to maintain 0.5-1.5 Pa, apply a bias voltage of -500 to -1000 V and bombard with argon ions for 15-40 min; then maintain a base vacuum of 5×10⁻⁶ Pa. -4 Under the conditions of Pa and rotating rack 10-20 r / min, using a DC power of 150-200 W, a gold transition layer of about 100-500 nm was obtained by sputtering with a high-purity gold target for 200-1000 s. When depositing platinum in the vapor phase, PVD, CVD, PECVD, ALD, etc. can be used, with CVD being the preferred method. The specific process is as follows: the equipment is moved into the vacuum chamber and the vacuum is evacuated to 5 × 10⁻⁶. -4The process involves heating to 120-180℃, rotating the rack at 10-20 r / min, using trimethylcyclopentadiene platinum as a precursor, heating the precursor to 80-100℃ to vaporize it, using argon as the carrier gas at a flow rate of 50-200 sccm, using oxygen as the reactant gas at a flow rate of 100-300 sccm, operating at 100-300 Pa, using RF power of 100-300 W, and depositing for 30-90 min to obtain a platinum transition layer of approximately 100-500 nm.

[0036] For palladium vapor deposition, PVD, CVD, PECVD, ALD, etc. can be used, with PVD being the preferred method. The specific process is as follows: vacuuming to 5×10 -4 Heat to 100-180℃, rotate the rack at 10-20 r / min, inject 50-90 sccm of argon gas to maintain 0.5-1.5 Pa, apply a bias voltage of -500 to -1000 V and bombard with argon ions for 15-40 min; then maintain a base vacuum of 5×10⁻⁶ Pa. -4 Pa, rotating rack 10-20 r / min, DC power 150-200 W, high-purity palladium target sputtering deposition for 300-1500 s, to obtain a palladium transition layer of about 100-500 nm.

[0037] When depositing copper in the vapor phase, PVD, CVD, PECVD, ALD, etc. can be used, with PVD being the preferred method. The specific process is as follows: the instrument sample is transferred into the vacuum chamber and the vacuum is evacuated to 5 × 10⁻⁶. -4 The solution is heated to 100-180℃, rotated at 10-20 r / min, injected with 40-80 sccm of argon gas, maintained at 1.3-3.0 Pa, and subjected to argon ion bombardment cleaning at a bias voltage of -500 to -800 V for 15-30 min. Subsequently, a copper transition layer of approximately 1-3 μm is obtained by sputtering with a high-purity copper target at a DC power of 200-300 W for 1500-3600 s.

[0038] For zinc vapor deposition, PVD, CVD, PECVD, ALD, etc. can be used, with PVD being the preferred method. The specific process is as follows: the equipment is moved into the vacuum chamber and the vacuum is evacuated to 5 × 10⁻⁶. -4 Pa, heated to 120-150℃, rotated at 10-20 r / min, injected with 30-60 sccm of argon gas to maintain 0.8-1.8 Pa, and subjected to argon ion bombardment with a bias voltage of -300 to -600 V for 15-30 min; then, maintaining a base vacuum of 5×10 -4Under the conditions of Pa and a rotating stand of 10-20 r / min, using a DC power of 50-100 W, a zinc transition layer of about 1-3 μm is obtained by sputtering with a high-purity zinc target for 2000-6000 s. (Note: If an electrochemical deposition of a dissimilar metal is attempted on this zinc transition layer, an uncontrollable displacement reaction will occur, leading to the dissolution of the zinc layer and loss of adhesion. Therefore, subsequent thickening can only be achieved by electrochemical deposition of zinc.)

[0039] When depositing silver in the vapor phase, PVD, CVD, PECVD, ALD, etc. can be used, with PVD being the preferred method. The specific process is as follows: the equipment is moved into the vacuum chamber and the vacuum is evacuated to 5 × 10⁻⁶. -4 Pa, heated to 130-200℃, rotated at 10-15 r / min, injected with 40-60 sccm of argon gas to maintain 2.0-8.0 Pa, and subjected to argon ion bombardment with a bias voltage of -500 to -800 V for 10-20 min; then maintained at a base vacuum of 5×10 -4 Under the conditions of Pa and a rotating stand of 10-15 r / min, using a DC power of 100-150 W, a silver transition layer of about 1-3 μm was obtained by sputtering deposition using a high-purity silver target for 900-2000 s.

[0040] In some embodiments of the present invention, the electrochemical deposition process is as follows: the deposited metal is one or more of gold, platinum, palladium, silver, copper, zinc, etc.; when electrochemically depositing silver, the specific process formulation parameters are: 28-40 g / L silver nitrate, 80-120 g / L 5,5-dimethylhydantoin, 50-100 g / L potassium citrate, 15-25 g / L potassium carbonate, 30-60 g / L potassium hydroxide, 20-50 mg / L 4,6-dimethyl-2-mercaptopyrimidine, 1-3 g / L polyvinylpyrrolidone (K15-K30), 0.5-1.5 g / L 2,2'-bipyridine, and 0.2-1.0 g / L polyethylene glycol 400-6000. The pH was adjusted to 10-11.5 using potassium hydroxide, and the temperature was raised and maintained at 35-40℃. A 99.99% pure silver plate was used as the anode, and the sample as the cathode. Deposition was performed using a dual-pulse power supply, with the forward pulse current density set to 0.3-0.8 A / dm³. 2 Pulse width 1-5 ms, duty cycle 10%-25%; reverse pulse current density 0.1-0.53 A / dm³ 2 The process involves a pulse width of 1-3 ms, a duty cycle of 5-10%, a pulse frequency of 500-1000 Hz, and a deposition time of 15-30 min to obtain a silver coating of approximately 5-10 μm. During the electroplating process, air agitation and continuous filtration of the plating solution are employed.

[0041] The specific process parameters for electrochemical copper deposition are as follows: 20-45 g / L copper pyrophosphate, 200-280 g / L potassium pyrophosphate, 10-18 g / L ammonium citrate, 12-25 g / L potassium sulfate, 2-6 g / L sodium hydroxide, 0.6-1.5 g / L polyethylene glycol 6000, 0.5-0.9 g / L potassium antimony tartrate, with the remainder being deionized water. Pure copper is used as the anode, and the sample is used as the cathode. The electrolyte pH is 8.0-9.5. The plating bath is heated and kept constant at 45-50℃. Deposition is performed using a dual-pulse power supply, with the forward pulse current density set at 0.3-0.5 A / dm³. 2 Pulse width 2-5 ms, duty cycle 20-40%, reverse pulse current density 0.1-0.3 A / dm³ 2 With a pulse width of 0.5-2 ms, a duty cycle of 5-10%, and a pulse frequency of 300-800 Hz, the electrolyte is continuously filtered under mechanical stirring at 10-300 rpm, and deposition is carried out for 20-50 min to obtain a copper coating of about 5-15 μm.

[0042] The specific process parameters for electrochemical zinc deposition are as follows: 10-18 g / L zinc oxide, 120-160 g / L sodium hydroxide, 30-50 g / L sodium carbonate, 20-40 g / L sodium citrate, 10-20 g / L potassium sodium tartrate, 0.1-0.5 g / L L-cysteine, and the remainder being deionized water; a pure zinc plate (purity ≥99.99%) is used as the anode, and the sample is used as the cathode; the plating bath is kept at a constant temperature of 20-30℃; a dual-pulse power supply is used for deposition, with the forward pulse current density set at 0.5-1.2 A / dm³. 2 Pulse width 2-4 ms, duty cycle 20-35%, reverse pulse current density 0.1-0.3 A / dm³ 2 The pulse width is 0.5-1.5 ms, the duty cycle is 5-8%, the pulse frequency is 300-600 Hz, and the electrolyte is continuously filtered under mechanical stirring at 10-20 rpm. After deposition for 30-60 min, a zinc coating of about 5-10 μm is obtained.

[0043] The specific process for electrochemical platinum deposition is as follows: 12-20 g / L chloroplatinic acid, 25-35 g / L diammonium hydrogen phosphate, 17-25 g / L sodium dihydrogen phosphate, 8.5-15 g / L citric acid, 0.15-0.6 g / L sodium saccharin, 0.06-0.2 g / L sodium dodecyl sulfate, with the remainder being deionized water. A platinum-plated titanium mesh (insoluble anode) is used as the anode, and the sample is used as the cathode. The plating bath is kept at a constant temperature of 80-85℃, and the pH is maintained at 7.0-8.5. A dual-pulse power supply is used for deposition, with the forward pulse current density set at 0.2-1.0 A / dm³. 2Pulse width 1-4ms, duty cycle 10-50%, reverse pulse current density 0.05-0.2 A / dm³ 2 The pulse width is 0.3-1.0 ms, the duty cycle is 3-8%, the pulse frequency is 200-500 Hz, the electrolyte is continuously filtered under mechanical stirring at 10-30 rpm, and the deposition takes 10-30 min to obtain a platinum coating of about 5-10 μm.

[0044] The specific process parameters for electrochemical gold deposition are as follows: potassium gold sulfite 15-30 g / L, sodium sulfite 80-120 g / L, potassium citrate 50-100 g / L, potassium carbonate 15-25 g / L, potassium hydroxide 10-20 g / L, 4,6-dimethyl-2-mercaptopyrimidine 20-50 mg / L, polyvinylpyrrolidone (K15-K30) 1-3 g / L, 2,2′-bipyridine 0.1-0.5 g / L, and polyethylene glycol 400-6000 0.2-1.0 g / L. g / L; adjust pH to 8.5-9.5 using potassium hydroxide, heat and maintain temperature at 45-55℃, use air agitation and continuous filtration of the plating solution during electroplating, use insoluble anodes such as 99.99% pure gold plates or platinum-titanium mesh, and use the sample as the cathode, using a dual-pulse power supply for deposition, setting the forward pulse current density to 0.2-0.5 A / dm³. 2 Pulse width 1-5 ms, duty cycle 10-25%, reverse pulse current density 0.05-0.3 A / dm³ 2 With a pulse width of 1-3 ms, a duty cycle of 5-10%, a pulse frequency of 500-1000 Hz, and a deposition time of 15-30 min, a gold coating of approximately 5-10 μm is obtained.

[0045] In some embodiments of the present invention, the adhesive removal includes: removing adhesive from the masking layer located on the outer surface of the instrument using a force-controlled semi-automatic peeling process, and removing adhesive from the masking layer located in the instrument's holes, grooves, or tubes using a steel needle piercing and unscrewing method.

[0046] In some embodiments of the present invention, during the adhesive removal process, the sample with the completed coating deposition is fixed on a contour positioning fixture, which is manufactured according to the three-dimensional model of the instrument, forms a contour fit with the outer contour of the instrument, and uses multi-point flexible clamping to prevent the instrument from bending and deforming during the peeling process.

[0047] In some embodiments of the present invention, for surface adhesives, a semi-automated force-controlled peeling process based on a robotic arm is used to remove the adhesive. This includes: a gripper is mounted at the end of the robotic arm, with a torque sensor between them; a vision system first performs a global image of the sample, which can be a high-resolution industrial camera, coupled with a coaxial LED ring light source and an ultraviolet auxiliary light source. Since the selected UV-curable adhesive itself contains fluorescent substances, it can stably emit visible fluorescence under ultraviolet light excitation after curing. The vision system utilizes this characteristic, along with a bandpass filter of the corresponding wavelength, to effectively separate the adhesive layer area from the titanium alloy substrate area. After image acquisition, the system sequentially performs Gaussian filtering noise reduction, adaptive threshold segmentation, morphological closing operation filling, and connected component analysis, removing areas smaller than 0.5 mm. 2 Isolated noise points are identified, and then an ordered set of points on the adhesive layer boundary is extracted using the Canny edge detection operator. Based on this set of points, the discrete curvature of each point is calculated, the starting point for peeling is automatically selected, and the robotic arm is controlled to execute the pre-planned peeling path.

[0048] In some embodiments of the present invention, the selection rules for the peeling starting point are, in order of priority: curvature greater than 0.2 mm. -1 The maximum point, the midpoint of the longest continuous straight line segment, or the point on a smooth curve segment closest to the tooling clamping point.

[0049] In some embodiments of the present invention, the peeling path planning can adopt a three-stage design. The first stage is normal entry: the gripper descends vertically from 8mm above the peeling point at 10mm / s, contacts the edge of the adhesive layer in a direction perpendicular to the instrument surface, and clamps the adhesive end after applying a pre-pressure of 0.3-0.8N. The second stage is tangential peeling: after the operator confirms the peeling angle (30°-45°) and peeling speed (10-20mm / s) through the human-machine interface, the program is started. The gripper moves horizontally along the boundary tangentially, while the tooling drives the instrument to rotate and feed in a coordinated manner according to the pre-programmed path. The end effector of the robotic arm calculates the posture in real time to keep the peeling angle constant within the set range, and the gripper continuously tears off the adhesive film at a uniform speed. The third stage is normal exit: after the gripper moves to the end point, the vision system confirms that the adhesive film has completely detached from the instrument surface, the gripper opens and sends the waste adhesive into the waste bin.

[0050] In some embodiments of the present invention, during the peeling process, a torque sensor (range 0-50 N·m, accuracy ±0.05 N·m, sampling frequency 100 Hz) installed in series between the wrist flange of the robotic arm and the flexible gripper collects the peeling resistance torque in real time. Before the formal peeling, the system automatically performs three standard tests at a peeling angle of 37.5° and a speed of 15 mm / s, and takes the average torque as the benchmark value. During the peeling process, the controller calculates the average real-time torque using a 0.5-second sliding window and makes judgments according to the following logic: When the real-time torque is within 0.8 to 1.2 times the baseline value, the system determines that the peeling is normal and continues execution; when the real-time torque exceeds 1.5 times the baseline value and lasts for more than 0.5 seconds, it is determined that the adhesive layer is too strongly adhered (possibly caused by over-curing or adhesive layer contamination), and the system immediately triggers an audible and visual alarm and pauses, awaiting manual intervention; when the real-time torque drops sharply to below 0.2 times the baseline value, and the vision system confirms that there is still adhesive film residue in the masked area, it is determined that the adhesive layer is broken (possibly caused by internal defects in the adhesive layer or detachment of the grippers), and the system also triggers an audible and visual alarm and pauses; when the real-time torque drops to below 0.1 times the baseline value, and the vision system confirms that there is no adhesive film residue, the peeling is determined to be complete, and the system automatically proceeds to the next process.

[0051] In some embodiments of the present invention, an ion curtain (ion balance ±10V, airflow 0.5-1.0m³) is simultaneously activated during the stripping process. 3 ( / min) to neutralize the static electricity generated during peeling and prevent adhesive residue from being attracted back to the instrument surface due to static electricity.

[0052] In some embodiments of the present invention, for adhesive inside holes / grooves / tubes, a steel needle piercing and unscrewing method is used for removal. A vision system uses a high-resolution industrial camera with a telecentric lens to acquire images of the hole position, and extracts the hole center coordinates (positioning accuracy ±0.05mm) and hole diameter using a Hough circle detection algorithm. Two tungsten steel needles with a diameter of 0.3-0.8mm, the needle tips machined into a 30° conical angle and coated with a diamond-like carbon coating to reduce friction, descend in a parallel posture and vertically pierce the adhesive block at a speed of 5-10mm / s. The piercing depth is controlled to 80%-90% of the adhesive block height; the specific value is automatically calculated by the system based on a preset hole depth minus a safety distance of 0.3-0.5mm. The reaction force is monitored in real time during the piercing process, with an upper limit set at 15N; exceeding this limit stops the process and triggers an alarm. After the steel needle is inserted into place, the clamping mechanism rotates in the same direction at a speed of 0.5-2 r / s, using the frictional torque between the steel needle and the rubber block to rotate the rubber block out of the hole; at the same time, the tooling retracts along the hole axis at a speed of 2-5 mm / s, forming a combined rotation-pull-out motion to ensure that the rubber block is completely removed without breaking.

[0053] In some embodiments of the present invention, after the adhesive layer inside the hole / groove / tube structure is removed, an endoscope camera (with built-in LED illumination) with an outer diameter not exceeding 1.0 mm is inserted into the hole to inspect for residual adhesive. If residual adhesive debris is found to cover an area exceeding 0.1 mm... 2 If the length exceeds 0.3mm, use a low-pressure plasma spray gun (50W power, argon flow rate 5L / min) for localized ashing cleaning for 5-10 seconds, and then re-inspect with an endoscope until the hole is clean.

[0054] Comparative Example 1 1) The titanium alloy (TC4) instrument sample (screw in this example) was placed in an oil removal tank for degreasing. The solution formula was 25 g / L sodium hydroxide, 12 g / L sodium carbonate, 12 g / L sodium metasilicate pentahydrate, 4 g / L fatty alcohol polyoxyethylene ether, 3 g / L sodium citrate, 2 g / L sodium polyacrylate, 0.8 g / L benzotriazole, and the remainder was deionized water. The sample was soaked in the solution at 55°C and 150 W ultrasonic power for 25 min. Then it was rinsed with deionized water three times for 10 min each time. After rinsing, the surface moisture was dried with nitrogen. Then the sample was placed in a vacuum drying oven and dried at 60°C and 30 Pa vacuum for 10 min.

[0055] 2) Transfer the above-mentioned titanium alloy instrument sample into the vacuum chamber and evacuate it to 5×10⁻⁶. -4 Pa, heated to 180℃, rotated at 12 r / min, injected with 50 sccm of argon gas to maintain 1.5 Pa, and subjected to argon ion bombardment with a -500V bias for 15 min; then maintained at a base vacuum of 5 × 10 -4 Under the conditions of Pa, substrate temperature 180℃, and rotating rack speed 12r / min, a silver transition layer of approximately 0.8μm was obtained by sputtering with a high-purity silver target for 900s using a DC power of 150W.

[0056] 3) After the above samples cooled to room temperature, the samples were thickened using an electrochemically deposited silver elemental coating. The specific process was as follows: 35 g / L silver nitrate, 80 g / L 5,5-dimethylhydantoin, 60 g / L potassium citrate, 25 g / L potassium carbonate, 45 g / L potassium hydroxide, 50 mg / L 4,6-dimethyl-2-mercaptopyrimidine, 1.5 g / L polyvinylpyrrolidone K30, 0.8 g / L 2,2'-bipyridine, and 1.0 g / L polyethylene glycol 2000. The pH was adjusted to 10.5 using potassium hydroxide, and the temperature was heated and kept constant at 38°C. A 99.99% pure silver plate was used as the anode, and the sample was used as the cathode. A dual-pulse power supply was used for deposition. During the electroplating process, air agitation was used, and the plating solution was continuously filtered. The forward pulse current density was set to 0.5 A / dm³. 2 Pulse width 4ms, duty cycle 25%, reverse pulse current density 0.1A / dm³ 2A silver coating of approximately 5 μm was obtained by deposition at a pulse width of 2 ms, a duty cycle of 10%, and a pulse frequency of 700 Hz for 20 min. The sample was then washed three times with deionized water for 10 min each time, dried with nitrogen, and then dried at 60℃ and 30 Pa vacuum for 30 min. It was then vacuum-packed using light-proof aluminum foil. 60 The desired finished product is obtained after irradiation sterilization at a Co dose of 35 kGy.

[0057] The high-strength antibacterial silver-coated TC4 instrument prepared in this comparative example was systematically characterized. The coating adhesion strength was tested using a universal testing machine, and the results showed an adhesion strength of approximately 38.6 MPa. Regarding biocompatibility, the proliferation of L929 fibroblasts was detected using the CCK-8 assay. After 5 days of co-culturing with the extract, the cell viability was approximately 90.4%. Live / dead cell staining showed good cell adhesion and no significant cytotoxicity. Antibacterial performance was evaluated using the inhibition zone method (1 cm * 1 cm sample, Escherichia coli), and the results showed an inhibition zone area of ​​approximately 3.24 cm². 2 A rabbit bone implantation model was constructed. When the screw was screwed into the bone, part of the silver coating on the head was detached. Pathological sections 7 days after implantation showed some inflammation around the screw, indicating that the detachment of the coating may lead to inflammation of the surrounding tissues. In addition, a rabbit intramedullary infection model was constructed. Bacterial smears 2 weeks after implantation showed that, compared with the uncoated TC4 instrument, only a small number of bacterial colonies were formed on the sample surface and in the surrounding tissue fluid, indicating that the infection was effectively controlled. Flow cytometry further quantitatively analyzed the cellular response induced by coating desquamation: Annexin V / PI double staining flow cytometry analysis of inflammatory cells extracted from the tissue surrounding the implantation site showed that the proportion of early apoptotic cells was approximately 12.4%, and the proportion of late apoptotic and necrotic cells was approximately 8.7%, both significantly higher than that of the normal tissue control (early apoptosis approximately 3.2%, late apoptosis and necrosis approximately 1.5%). At the same time, reactive oxygen species (ROS) fluorescent probe detection showed that the average fluorescence intensity of ROS in inflammatory cells was approximately 2.6 times that of the normal control, indicating that the silver particles and debris released by the coating desquamation induced a significant oxidative stress response, further aggravating the formation of the local inflammatory microenvironment, consistent with the inflammatory infiltration observed in pathological sections.

[0058] Example 1

[0059] 1) First, the titanium alloy (TC4) bone plate sample and the locking screw sample were obtained using a blue light structured light 3D scanner with a single frame accuracy of 0.02 mm and an overall error of ≤0.05 mm. The 3D models of the pure titanium bone plate and pure titanium locking screw were then imported into finite element analysis software. A bilinear isotropic strengthening model (elastic modulus 110 GPa, Poisson's ratio 0.3, yield strength 945 MPa, ultimate strength 1.042 GPa) was used to capture its elastic and plastic deformation stages. The high-fidelity models of the bone plate and screw were assembled, including detailed screw hole conical surfaces and thread geometry to accurately simulate clinical locking dynamics. An optimized hybrid mesh generation method was used: C3D10M quadratic tetrahedral elements (global size 0.3 mm) were used in the main body of the bone plate and screw body, while the mesh density was reduced to 0.08 mm in the contact area between the screw hole inner wall and the screw head and threads. Strict control was exercised over the element quality indicators. The interaction between the inner wall of the screw hole and the screw head and threads was modeled using a surface-to-surface contact algorithm. The normal direction was defined as hard contact, and the tangential direction was modeled using Coulomb friction (friction coefficient μ=0.3) to accurately characterize the mechanical coupling between the two. The entire screwing-in locking process was simulated using explicit dynamic analysis, lasting 0.1 seconds. A combined load was applied to the screw head: axial tensile force increased linearly from 0 to a peak value of 800 N / s at a loading rate of 400 N / s, while a constant rotational speed of 62.8 rad / s (approximately 600 rpm) was applied to simulate the screw's rotational feed motion during clinical locking. The load application was based on a clinically relevant anatomical coordinate system (Z-axis: along the screw axis from head to tail; X-axis and Y-axis: two orthogonal directions in a plane perpendicular to the axial direction). The stress evolution of the inner wall of the screw hole during the complete screw insertion process was systematically analyzed using incremental solution techniques, focusing on identifying and quantifying the stress concentration phenomenon on the inner wall of the screw hole at the peak torque moment (approximately 30° rotation angle). Finally, the Von Mises yield criterion was used to comprehensively characterize the stress distribution. The simulated maximum Von Mises stress at the nail hole edge was 415.3 MPa. The contact stress distribution between the inner wall of the bone plate nail hole and the head and threads of the locking screw was extracted. Using 75% of the material yield strength (415.3 MPa) (i.e., 311 MPa) as the threshold, the nail hole edge area exceeding this threshold was designated as an uncoated area, and the remaining area was designated as an unmasked coated area, thus completing the coating partitioning (the stress analysis results for one nail hole in the bone plate are shown in the figure). Figure 2 ).

[0060] 2) The above samples were placed in an oil removal tank for oil removal. The solution formulation was 25 g / L sodium hydroxide, 12 g / L sodium carbonate, 12 g / L sodium metasilicate pentahydrate, 4 g / L fatty alcohol polyoxyethylene ether, 3 g / L sodium citrate, 2 g / L sodium polyacrylate, 0.8 g / L benzotriazole, with the remainder being deionized water. The samples were soaked in the solution at 55℃ and 150W ultrasonic power for 25 minutes, followed by rinsing with deionized water three times for 10 minutes each. After rinsing, the surface moisture was dried with nitrogen. Then, the samples were placed in a vacuum drying oven and dried at 60℃ and 30Pa vacuum for 10 minutes. After cooling to room temperature, the partitioned model was imported into a four-axis fully automatic dispensing machine. A four-eye industrial camera combined with a laser line scanner was used for three-dimensional calibration and scanning of the actual bone plate. After registering and aligning the spatial pose with the partition model, the uncoated area was automatically defined. High-temperature resistant masking adhesive DymaxSpeedMask®728-G (0.35% linear shrinkage) was applied in two stages: In the first stage, an L-shaped bent needle with an inner diameter of 80μm was used to outline the uncoated area boundary at 0.1MPa air pressure and 8mm / s speed, controlling the adhesive line width to approximately 100μm and covering all high-stress concentration areas. The boundary was then pre-cured for 3 seconds using a UV-LED point light source to lock it in place. In the second stage, a straight needle with an inner diameter of 200μm was used to fill the boundary area at 0.25MPa air pressure and 15mm / s speed, completely filling the screw holes until the surface was flush and free of air bubbles. After all adhesive was applied, an irradiation was applied at a wavelength of 385nm and an intensity of 100mW / cm². 2 The UV-LED surface light source was exposed and cured for 8 minutes, then baked at 120℃ for 30 minutes and cooled in the oven. Visual inspection confirmed complete shielding (e.g. Figure 3 ).

[0061] 3) The above samples underwent dual plasma stripping. The specific process was as follows: the bone plate was immersed at room temperature in a stripping solution composed of 60 g / L citric acid, 20 g / L ammonium fluoride, and 3 g / L imidazole for 150 seconds. After removal, it was rinsed with deionized water, dried with nitrogen, and vacuum dried. It was then transferred to a vacuum chamber and evacuated to 5 × 10⁻⁶. -3 The pressure was increased to Pa and heated to 150°C to desorb water vapor. A 3:1 argon-hydrogen mixture was introduced to maintain a working pressure of 3 Pa. A 200W RF power and a -80V negative bias were applied for cleaning for 20 minutes. Then, the hydrogen was stopped, the RF power was increased to 300W, and the negative bias was reduced to -150V. High-energy argon ion bombardment was performed for cleaning for 10 minutes. Immediately following, PVD silver was applied. The specific process involved moving the instrument into a vacuum chamber and evacuating it to a vacuum level of 5 × 10⁻⁶ Pa. -4 Pa, heated to 100℃, rotated at 10 r / min, injected with 45 sccm of argon gas to maintain 3.0 Pa, and subjected to argon ion bombardment with a -500V bias for 20 min; then maintained at a base vacuum of 5 × 10 -4Under conditions of Pa, substrate temperature 180℃, and rotor speed 10r / min, using a DC power of 150W, a high-purity silver target was sputtered for 900s to obtain a silver transition layer of approximately 1μm. After cooling to room temperature, elemental silver was subsequently thickened using electrochemical deposition. The specific process parameters were: 32g / L silver nitrate, 85g / L 5,5-dimethylhydantoin, 75g / L potassium citrate, 15g / L potassium carbonate, 34.5g / L potassium hydroxide, and 28mg / L... 4,6-Dimethyl-2-mercaptopyrimidine, 1.2 g / L polyvinylpyrrolidone K30, 0.9 g / L 2,2'-bipyridine, and 0.7 g / L polyethylene glycol 2000 were used. The pH was adjusted to 11.5 with potassium hydroxide, and the solution was heated and kept constant at 38°C. Air agitation and continuous filtration of the plating solution were employed during electroplating. A 99.99% pure silver plate was used as the anode, and the sample as the cathode. Deposition was performed using a dual-pulse power supply with a forward pulse current density of 0.5 A / dm³. 2 Pulse width 5ms, duty cycle 25%; reverse pulse current density 0.2A / dm³ 2 With a pulse width of 3ms, a duty cycle of 10%, and a pulse frequency of 800Hz, deposition was carried out for 20 minutes to obtain a silver coating of approximately 5μm (e.g., ...). Figure 4 ).

[0062] 4) After removing the above-mentioned instrument samples from the electroplating tank, rinse them three times with deionized water for 3 minutes each time, dry them with nitrogen, and then place them in a 60℃ forced-air drying environment for 30 minutes. After cooling to room temperature, manually fix the instruments horizontally onto a contour-following positioning fixture with a universal interface. The fixture can be adapted to the contour of the instrument to prevent bending and deformation. Then, start the semi-automatic peeling program, using a steel needle piercing and unscrewing method to remove the adhesive: the head of the adhesive removal fixture is equipped with four high-strength hard fine steel needles. After the system visually identifies the position of the adhesive block in the hole, the steel needles accurately pierce into the adhesive block. Then, the fixture rotates to drive the adhesive block out of the hole and remove it. The peeling speed is 10mm / s. Simultaneously, the ion air curtain is automatically turned on to eliminate static electricity and prevent adhesive residue from being sucked back. The peeling is considered complete after the torque sensor detects that the peeling force is continuously lower than the adhesive removal threshold and the visual recognition confirms that there is no residual adhesive in the shielded area. After peeling is completed, it is transferred to the automatic optical inspection station, using a high-resolution process. A professional camera, combined with a multi-angle ring light source and ultraviolet-excited fluorescence imaging, automatically scans the instrument surface to identify residual adhesive. After detection, the adhesive is cleaned online using a low-pressure plasma spray gun for localized ashing. Special structural areas are then manually re-inspected under a 1200 Lux illuminance light source and cleaned again with plasma. The instrument is then transferred to deionized water for ultrasonic cleaning for 5 minutes, followed by rinsing three times with deionized water for 2 minutes each time. After drying with nitrogen, the sample is dried at 60℃ and 30Pa vacuum for 30 minutes. It is then vacuum-packed using light-proof aluminum foil. 60 The desired product is obtained after irradiation sterilization at a Co dose of 35 kGy (e.g., ...). Figure 5 ).

[0063] Compared to Comparative Example 1, this embodiment introduces masking technology and localized vapor-deposited silver coating technology. The sample performance was characterized as follows: the coating adhesion strength was tested using a universal testing machine, and the results showed an adhesion strength of approximately 38.7 MPa. Regarding biocompatibility, the CCK-8 assay was used to detect the proliferation of L929 fibroblasts; after 5 days of co-culturing with the extract, the cell viability was approximately 92.6%, with no significant cytotoxicity. The antibacterial performance was evaluated using the inhibition zone method (using 1cm*1cm samples, with Escherichia coli as the bacterial species, including fully coated and partially coated samples, both prepared using step 3 of this embodiment). The partially coated samples used the same adhesive and curing parameters as in Example 2 for masking. The fully silver-coated samples showed an inhibition zone area of ​​approximately 3.15 cm². 2 An inhibition zone experiment was conducted using samples with partial silver plating (excluding a 1mm x 1mm area on one corner of a square sample). The results showed that the inhibition zone area was approximately 3.07 cm². 2 This indicates that local plating has virtually no impact on antibacterial ability. A canine bone implantation model was constructed, using a steel plate obtained in this embodiment that was not silver-plated except for the inner hole. When the locking screw was screwed into the bone through the steel plate, no coating peeling occurred. Pathological sections taken 7 days after implantation showed no inflammation in the surrounding tissue. A canine intramedullary infection model was further constructed. Bacterial smears taken 2 weeks after implantation showed that, compared to Comparative Example 1, there was virtually no bacterial colony formation on the sample surface (silver-plated and unplated areas) and in the surrounding tissue fluid, indicating effective infection control.

[0064] Example 2

[0065] 1) First, a 3D model of a pure titanium screw was obtained from a titanium alloy (TC4) orthopedic instrument sample using a blue light structured light 3D scanner with a single-frame accuracy of 0.02 mm and an overall error of ≤0.05 mm. Based on bilateral lower limb CT scan data, the 3D femoral geometry was reconstructed in Abaqus 2023 through computational modeling. Reverse engineering techniques were used to achieve anatomical accuracy while ensuring computational efficiency. The cortical bone was modeled as a homogeneous isotropic material to specifically evaluate its mechanical response to implant placement, with particular attention to the stress distribution pattern at the bone-implant interface. A high-fidelity model of the aforementioned pure titanium screw, including detailed thread geometry, was created to accurately simulate clinical placement dynamics. A systematic material constitutive model was implemented: intact cortical bone was modeled using an isotropic linear elastic constitutive model (Young's modulus E = 16.8 GPa, Poisson's ratio ν = 0.3); while for areas with potential bone damage, an isotropic elastoplastic model incorporating toughness damage criteria was adopted (E = 16.8 GPa, ν = 0.3, yield strength σy = 120 MPa, ultimate strength σu = 140 MPa, density ρ = 1.64 × 10⁻⁶). -9 t / mm 3The failure strain εf = 0.03 was used. The implant material behavior was modeled using a bilinear isotropic strengthening model (E = 110 GPa, ν = 0.3, σy = 945 MPa, σu = 1.042 GPa) to capture its elastic and plastic deformation stages. Computational efficiency was improved through an optimized hybrid mesh generation method: C3D10M quadratic tetrahedral elements were used in regions requiring high solution accuracy (intact bone and screw), while C3D8R reduced integral hexahedral elements were used in potentially damaged regions, with strict control over element quality indices. Boundary conditions were set to fully constrain the distal femur. The bone-implant interface interaction was modeled using an advanced surface-to-surface contact algorithm, with the normal direction defined as hard contact and the tangential direction using Coulomb friction (friction coefficient μ = 0.3) to accurately characterize the mechanical coupling between the bone and the implant. The entire implantation process was simulated using explicit dynamic analysis for 0.1 seconds. A combined load condition was applied to the screw head: an axial insertion force (loading rate 400 N / s) superimposed with a constant rotational speed (62.8 rad / s). The load application was based on a clinically relevant anatomical coordinate system (Z-axis: distal to proximal along the femoral shaft, X-axis: medial-lateral direction, Y-axis: anterior-posterior direction). Incremental solution techniques were used to systematically analyze the stress evolution during the screw's three complete rotations, focusing on identifying and quantifying the stress concentration phenomenon at the moment of maximum torque application (30° rotation angle). Finally, the Von Mises yield criterion was used to comprehensively characterize the stress distribution. The contact stress distribution between the screw and bone was extracted. Using 75% of the material's yield strength as a threshold, the screw thread area exceeding the threshold was designated as an uncoated area, and the remaining area was designated as an unmasked coated area, thus completing the coating zoning.

[0066] 2) The above samples were placed in an oil removal tank for oil removal. The solution formulation was 25 g / L sodium hydroxide, 12 g / L sodium carbonate, 12 g / L sodium metasilicate pentahydrate, 4 g / L fatty alcohol polyoxyethylene ether, 3 g / L sodium citrate, 2 g / L sodium polyacrylate, 0.8 g / L benzotriazole, with the remainder being deionized water. The samples were soaked in the solution at 55℃ and 150W ultrasonic power for 25 minutes, followed by rinsing with deionized water three times for 10 minutes each. After rinsing, the surface moisture was dried with nitrogen. The samples were then placed in a vacuum drying oven and dried at 60℃ and 30Pa vacuum for 10 minutes. After cooling to room temperature, the partitioned model was imported into a four-axis fully automatic dispensing machine. A four-eye industrial camera combined with a laser line scanner was used for 3D calibration and scanning of the screws to determine their spatial pose. After model registration and alignment, the uncoated areas were automatically defined. High-temperature resistant masking adhesive DymaxSpeedMask®728-G (0.35% linear shrinkage) was applied in two stages: In the first stage, an L-shaped bent needle with an inner diameter of 80μm was used to outline the uncoated area boundary at 0.1MPa air pressure and 8mm / s speed, controlling the adhesive line width to approximately 100μm and covering all high-stress concentration areas. The boundary was then pre-cured for 3 seconds using a UV-LED point light source to lock it in place. In the second stage, a straight needle with an inner diameter of 200μm was used to fill the boundary area at 0.25MPa air pressure and 15mm / s speed, creating a second layer of adhesive film on the screw thread area, forming a continuous and uniform film with a wet film thickness of approximately 800μm. After all dispensing was completed, an irradiation was applied at a wavelength of 385nm and an intensity of 100mW / cm². 2 The UV-LED surface light source was exposed and cured for 8 minutes, then baked at 120℃ for 30 minutes and cooled in the oven. Visual inspection confirmed that the masking was complete.

[0067] 3) The above samples underwent dual plasma stripping. The specific process was as follows: the bone plate was immersed at room temperature in a stripping solution composed of 60 g / L citric acid, 20 g / L ammonium fluoride, and 3 g / L imidazole for 150 seconds. After removal, it was rinsed with deionized water, dried with nitrogen, and vacuum dried. It was then transferred to a vacuum chamber and evacuated to 5 × 10⁻⁶. -3 The pressure was increased to Pa and heated to 100℃ to desorb water vapor. A 3:1 argon-hydrogen mixture was introduced to maintain a working pressure of 3 Pa. A 200W RF power and a -80V negative bias were applied for cleaning for 20 minutes. Then, the hydrogen was stopped, the RF power was increased to 300W, and the negative bias was increased to -150V. High-energy argon ion bombardment was performed for cleaning for 10 minutes. Immediately afterwards, copper vapor deposition was performed. The specific process was as follows: the instrument sample was transferred into the vacuum chamber, and the vacuum was evacuated to 5 × 10⁻⁶ Pa. -4The solution was heated to 120°C, rotated at 12 r / min, and injected with 50 sccm of argon gas, maintained at 1.3 Pa. Argon ion bombardment was applied at a bias of -600V for 15 min. Subsequently, a copper transition layer of approximately 1 μm was deposited by sputtering on a high-purity copper target for 1500 s under DC power of 200W. After cooling to room temperature, electrochemical thickening was performed using the following process: 30 g / L copper pyrophosphate, 220 g / L potassium pyrophosphate, 13.4 g / L ammonium citrate, 13 g / L potassium sulfate, 2.5 g / L sodium hydroxide, 0.6 g / L polyethylene glycol 2000, 0.9 g / L potassium antimony tartrate, with the remainder being deionized water. Pure copper was used as the anode, and the sample as the cathode. The pH of the electrolyte was adjusted to 9.0, and the plating bath was heated and held at 50°C. Deposition was performed using a dual-pulse power supply with a forward pulse current density of 0.5 A / dm³. 2 Pulse width 5ms, duty cycle 40%, reverse pulse current density 0.1A / dm³ 2 With a pulse width of 1ms, a duty cycle of 10%, and a pulse frequency of 600Hz, the electrolyte was continuously filtered under mechanical stirring at 15rpm, and deposition was carried out for 25min to obtain a copper coating of about 5μm.

[0068] 4) After removing the above-mentioned instrument samples from the electroplating tank, rinse them three times with deionized water for 3 minutes each time, dry them with nitrogen, and then place them in a 60°C forced-air drying environment for 30 minutes. After cooling to room temperature, manually fix the instrument horizontally onto a contour-following positioning fixture with a universal interface. The fixture can be adapted to the contour of the instrument to prevent bending and deformation. Then, start the semi-automatic peeling program. The system automatically identifies the inner and outer boundaries of the shielded area through vision and plans the peeling point and peeling path. After manually confirming the peeling angle (45°) and peeling speed (10mm / s) given by the system on the screen, the force-controlled flexible gripper automatically lifts the edge of the adhesive layer at an angle of about 90° and clamps the adhesive end. The fixture automatically drives the instrument to rotate and feed in a coordinated manner according to the pre-programmed path. The gripper continuously peels off the adhesive along the contour of the instrument at a constant speed preset by the system. At the same time, the ion air curtain is automatically turned on to eliminate static electricity and prevent adhesive residue from being sucked back. The force sensor detects that the peeling force is continuously lower than the debonding threshold and visual recognition confirms that there is no residual adhesive film in the shielded area, and then the peeling is determined. After stripping, the sample is transferred to an automated optical inspection station. A high-resolution industrial camera, combined with a multi-angle ring light source and ultraviolet-excited fluorescence imaging, is used to automatically scan the surface of the instrument to identify residual adhesive. After detection, the residual adhesive is cleaned online by a low-pressure plasma spray gun for localized ashing. Special structural areas are visually re-inspected under a 1200 Lux illuminance light source and then cleaned with plasma. The instrument is then transferred to deionized water for ultrasonic cleaning for 5 minutes, followed by rinsing three times with deionized water for 2 minutes each time. After drying with nitrogen, the sample is dried at 60℃ and 30Pa vacuum for 30 minutes. It is then vacuum-packed using light-proof aluminum foil. 60 The desired product is obtained after irradiation sterilization at a Co dose of 35 kGy (e.g., ...). Figure 6 ).

[0069] Compared to Example 1, this example replaces the bone implantation device from a bone plate with a screw, and changes the plating type from silver to copper. The sample performance was characterized: the coating bonding strength was tested using a universal testing machine, and the results showed a bonding force of approximately 40.6 MPa. Regarding biocompatibility, the proliferation of L929 fibroblasts was detected using the CCK-8 assay; after 5 days of co-culturing with the extract, the cell viability was approximately 89.3%, with no significant cytotoxicity. Antibacterial performance was evaluated using the inhibition zone method (1cm*1cm sample, Escherichia coli); the fully copper-plated sample showed an inhibition zone area of ​​approximately 2.82 cm². 2 An inhibition zone experiment was conducted using samples with partial copper plating (excluding a 1mm x 1mm area on one corner of a square sample). The results showed that the inhibition zone area was approximately 2.78 cm². 2 A rabbit bone implantation model was constructed. When the screw from this embodiment was screwed into the bone, no coating peeling occurred at the head. Pathological sections taken 7 days after implantation showed no inflammation in the tissue surrounding the screw. A rabbit intramedullary infection model was further constructed. Bacterial smears taken 2 weeks after implantation showed that, compared to Comparative Example 1, only a small number of bacterial colonies formed on the sample surface (copper-plated and non-copper-plated areas) and in the surrounding tissue fluid (e.g., ...). Figure 7 The three samples on the right side of the middle section demonstrate that the coating has good antibacterial ability; at the same time, combined with Micro-CT detection, new bone formation was found on the sample surface, indicating the anti-infection effect and the ossification effect of copper ions, which can promote bone integration on the sample surface (e.g., Figure 8 (Right image in the middle)

[0070] Example 3

[0071] 1) Same as step 1 in Example 1).

[0072] 2) The above samples were placed in an oil removal tank for oil removal. The solution formulation was 25 g / L sodium hydroxide, 12 g / L sodium carbonate, 12 g / L sodium metasilicate pentahydrate, 4 g / L fatty alcohol polyoxyethylene ether, 3 g / L sodium citrate, 2 g / L sodium polyacrylate, 0.8 g / L benzotriazole, with the remainder being deionized water. The samples were soaked in the solution at 55℃ and 150W ultrasonic power for 25 minutes, followed by rinsing with deionized water three times for 10 minutes each. After rinsing, the surface moisture was dried with nitrogen gas. Then, the samples were placed in a vacuum drying oven and dried at 60℃ and 30Pa vacuum for 10 minutes. After cooling to room temperature, the partitioned model was imported into a four-axis fully automatic dispensing machine. A four-eye industrial camera combined with a laser line scanner was used for three-dimensional calibration and scanning of the bone plate. After aligning the spatial pose with the model, the uncoated areas were automatically defined. Ordinary masking adhesive ThreeBond was selected. 3057B is applied in two stages: In the first stage, an L-shaped bent needle with an inner diameter of 80μm is used to outline the uncoated area at a pressure of 0.1MPa and a speed of 8mm / s, controlling the glue line width to approximately 100μm and covering all high-stress concentration areas. The boundary is then pre-cured for 3 seconds using a UV-LED point light source to lock the edge. In the second stage, a straight needle with an inner diameter of 200μm is used to fill the area within the boundary at a pressure of 0.25MPa and a speed of 15mm / s, completely filling the screw holes until the surface is flush and free of air bubbles. After all glue is applied, an irradiation treatment is performed at a wavelength of 385nm and an intensity of 100mW / cm². 2 The UV-LED surface light source was exposed and cured for 8 minutes, then baked at 80℃ for 30 minutes and cooled in the oven. Visual inspection revealed that due to the high linear shrinkage rate of 3057B (3.3%) and the upper limit of its high temperature resistance (approximately 120℃), the adhesive layer underwent significant volume shrinkage after baking. This resulted in localized exposure at the boundary of the intended shielding area, and the uneven shrinkage caused the boundary between the exposed coating and the uncoated area to be irregular.

[0073] 3) The above samples underwent dual plasma stripping. The specific process was as follows: the bone plate was immersed at room temperature in a stripping solution composed of 60 g / L citric acid, 20 g / L ammonium fluoride, and 3 g / L imidazole for 150 seconds. After removal, it was rinsed with deionized water, dried with nitrogen, and vacuum dried. It was then transferred to a vacuum chamber and evacuated to 5 × 10⁻⁶. -3 The pressure was increased to Pa and heated to 100℃ to desorb water vapor. A 3:1 argon-hydrogen mixture was introduced to maintain a working pressure of 3 Pa. A 200W RF power and a -80V negative bias were applied for cleaning for 20 minutes. Then, the hydrogen was stopped, the RF power was increased to 300W, and the negative bias was reduced to -150V. High-energy argon ion bombardment was performed for cleaning for 10 minutes. Immediately following, PVD silver was applied. The specific process involved moving the instrument into a vacuum chamber and evacuating it to a vacuum level of 5 × 10⁻⁶ Pa. -4Pa, heated to 100℃, rotated at 10 r / min, injected with 45 sccm of argon gas to maintain 3.0 Pa, and subjected to argon ion bombardment with a bias voltage of -500 V for 20 min; then maintained at a base vacuum of 5 × 10 Pa. -4 Under conditions of Pa, substrate temperature 180℃, and rack speed 10 r / min, a high-purity silver target was sputtered for 900 s using a DC power of 150 W to obtain a silver transition layer of approximately 1 μm. After cooling to room temperature, elemental silver was subsequently thickened using electrochemical deposition. The specific process parameters were: 32 g / L silver nitrate, 85 g / L 5,5-dimethylhydantoin, 75 g / L potassium citrate, 15 g / L potassium carbonate, 34.5 g / L potassium hydroxide, 28 mg / L 4,6-dimethyl-2-mercaptopyrimidine, 1.2 g / L polyvinylpyrrolidone K30, and 0.9 g / L... 2,2'-Bipyridine, 0.7 g / L polyethylene glycol 2000, pH adjusted to 11.5 with potassium hydroxide, heated and kept constant at 38°C, air agitation and continuous filtration of the plating solution were used during electroplating. A 99.99% pure silver plate was used as the anode, and the sample as the cathode. Deposition was performed using a dual-pulse power supply with a forward pulse current density of 0.5 A / dm³. 2 Pulse width 5 ms, duty cycle 25%; reverse pulse current density 0.2 A / dm³ 2 With a pulse width of 3 ms, a duty cycle of 10%, and a pulse frequency of 800 Hz, a silver coating of approximately 5 μm was obtained after 20 min of deposition.

[0074] 4) After removing the above instrument samples from the electroplating tank, rinse them with deionized water 3 times for 3 minutes each time, blow them dry with nitrogen, and then place them in a 60°C blower for 30 minutes to dry. After cooling to room temperature, manually fix the instrument horizontally on a contour positioning fixture with a universal interface. The fixture can be adapted to the contour of the instrument to prevent bending and deformation. The semi-automatic peeling process is then initiated, using a steel needle piercing and unscrewing method for removal: the head of the adhesive removal fixture is equipped with four high-strength, hard, fine steel needles. After the system visually identifies the position of the adhesive block within the hole, the steel needles precisely pierce into the adhesive block. Subsequently, the fixture rotates, causing the adhesive block to unscrew and be removed from the hole at a peeling speed of 10 mm / s. Simultaneously, an ion curtain is automatically activated to eliminate static electricity and prevent adhesive residue from being drawn back in. The peeling process is considered complete once the force sensor detects that the peeling force is consistently below the adhesive removal threshold and visual recognition confirms that there is no residual adhesive film in the shielded area. After peeling, the device is transferred to an automatic optical inspection station. A high-resolution industrial camera, combined with a multi-angle ring light source and ultraviolet-excited fluorescence imaging, automatically scans the surface of the instrument to identify residual adhesive. After detecting residual adhesive, a low-pressure plasma spray gun performs online localized ashing cleaning. Special structural areas are supplemented with manual visual re-inspection under a 1200 Lux illuminance light source and plasma cleaning. The instrument is then transferred to deionized water for ultrasonic cleaning for 5 minutes, followed by rinsing with deionized water three times for 2 minutes each time. After drying with nitrogen, the sample was dried at 60℃ and 30Pa vacuum for 30 min; it was then vacuum-packed using light-proof aluminum foil. 60 The desired finished product is obtained after irradiation sterilization at a Co dose of 35 kGy.

[0075] Compared to Example 1, this example uses the common masking adhesive ThreeBond 3057B. The sample performance was characterized: the coating bond strength was tested using a universal testing machine, and the results showed a bond strength of 37.6 MPa, comparable to Example 1. Regarding biocompatibility, the CCK-8 assay was used to detect L929 fibroblast proliferation. After 5 days of co-culturing with the extract, the cell viability was approximately 72.3%, exhibiting significant cytotoxicity. This may be due to some adhesive residue, leading to enhanced cytotoxicity. Antibacterial performance was evaluated using the inhibition zone method (1cm × 1cm sample, Escherichia coli), and the inhibition zone area was approximately 3.39 cm². 2 A canine bone implantation model was constructed, using a steel plate obtained by the method in this embodiment that was not silver-plated except for the hole. When the locking screw was screwed into the bone through the steel plate, the coating of the steel plate did not fall off. Seven days after implantation, pathological sections showed that there was moderate inflammation in the tissue around the screw. A canine intramedullary infection model was further constructed. Two weeks after implantation, bacterial smears showed that only a small number of bacterial colonies formed on the sample surface and in the surrounding tissue fluid.

[0076] Example 4

[0077] 1) Same as step 1 in Example 1).

[0078] 2) The above samples were placed in an oil removal tank for oil removal. The solution formulation was 25 g / L sodium hydroxide, 12 g / L sodium carbonate, 12 g / L sodium metasilicate pentahydrate, 4 g / L fatty alcohol polyoxyethylene ether, 3 g / L sodium citrate, 2 g / L sodium polyacrylate, 0.8 g / L benzotriazole, with the remainder being deionized water. The samples were soaked in the solution at 55°C and 150W ultrasonic power for 25 minutes, followed by rinsing with deionized water three times for 10 minutes each. After rinsing, the surface moisture was dried with nitrogen. The samples were then placed in a vacuum drying oven and dried at 60°C and 30Pa vacuum for 10 minutes. After cooling to room temperature, the partitioned model was imported into a four-axis fully automatic dispensing machine. A four-eye industrial camera combined with a laser line scanner was used for three-dimensional calibration and scanning of the bone plate. After aligning the spatial pose with the model, the uncoated areas were automatically defined. High-temperature resistant masking adhesive Dymax SpeedMask® was selected. 728-G (linear shrinkage rate 0.35%) was applied in two stages: In the first stage, an L-shaped bent needle with an inner diameter of 80μm was used to outline the uncoated area at a pressure of 0.1MPa and a speed of 8mm / s, controlling the glue line width to approximately 100μm and covering all high-stress concentration areas. The boundary was then pre-cured for 3 seconds using a UV-LED point light source to lock the edge. In the second stage, a straight needle with an inner diameter of 200μm was used to fill the area within the boundary at a pressure of 0.25MPa and a speed of 15mm / s, completely filling the screw holes until the surface was flush and free of air bubbles. After all glue was applied, an irradiation was performed at a wavelength of 385nm and an intensity of 100mW / cm². 2 The UV-LED surface light source was exposed and cured for 8 minutes, then baked at 120℃ for 30 minutes and cooled in the oven. Visual inspection confirmed that the masking was complete.

[0079] 3) The above samples underwent dual plasma stripping. The specific process was as follows: the bone plate was immersed at room temperature in a stripping solution composed of 60 g / L citric acid, 20 g / L ammonium fluoride, and 3 g / L imidazole for 150 seconds. After removal, it was rinsed with deionized water, dried with nitrogen, and vacuum dried. It was then transferred to a vacuum chamber and evacuated to 5 × 10⁻⁶. -3 The pressure was increased to Pa and heated to 100℃ to desorb water vapor. A 3:1 argon-hydrogen mixture was introduced to maintain a working pressure of 3 Pa. A 200W RF power and a -80V negative bias were applied for cleaning for 20 minutes. Then, the hydrogen was stopped, the RF power was increased to 300W, and the negative bias was reduced to -150V. High-energy argon ion bombardment was performed for cleaning for 10 minutes. Immediately following, PVD silver was applied. The specific process involved moving the instrument into a vacuum chamber and evacuating it to a vacuum level of 5 × 10⁻⁶ Pa. -4 Pa, heated to 100℃, rotated at 10 r / min, injected with 45 sccm of argon gas to maintain 3.0 Pa, and subjected to argon ion bombardment with a bias voltage of -500 V for 20 min; then maintained at a base vacuum of 5 × 10 Pa. -4Under conditions of Pa, substrate temperature 180℃, and rack speed 10 r / min, a high-purity silver target was sputtered for 900 s using a DC power of 150 W to obtain a silver transition layer of approximately 1 μm. After cooling to room temperature, elemental silver was subsequently thickened using electrochemical deposition. The specific process parameters were: 32 g / L silver nitrate, 85 g / L 5,5-dimethylhydantoin, 75 g / L potassium citrate, 15 g / L potassium carbonate, 34.5 g / L potassium hydroxide, 28 mg / L 4,6-dimethyl-2-mercaptopyrimidine, 1.2 g / L polyvinylpyrrolidone K30, and 0.9 g / L... 2,2'-Bipyridine, 0.7 g / L polyethylene glycol 2000, pH adjusted to 11.5 with potassium hydroxide, heated and kept constant at 38°C, air agitation and continuous filtration of the plating solution were used during electroplating. A 99.99% pure silver plate was used as the anode, and the sample as the cathode. Deposition was performed using a dual-pulse power supply with a forward pulse current density of 0.5 A / dm³. 2 Pulse width 5 ms, duty cycle 25%; reverse pulse current density 0.2 A / dm³ 2 With a pulse width of 3 ms, a duty cycle of 10%, and a pulse frequency of 800 Hz, a silver coating of approximately 5 μm was obtained after 20 min of deposition.

[0080] 4) After removing the above-mentioned instrument samples from the electroplating tank, rinse them three times with deionized water for 3 minutes each time, dry them with nitrogen, and then place them in a 60℃ forced-air drying environment for 30 minutes. After cooling to room temperature, manually fix the instruments horizontally on a contour-following positioning fixture with a universal interface. The fixture can be adapted to the contour of the instrument to prevent bending and deformation. Then, start the semi-automatic peeling program, using a steel needle piercing and unscrewing method to remove the adhesive: the head of the adhesive removal fixture is equipped with four high-strength hard fine steel needles. After the system visually identifies the position of the adhesive block in the hole, the steel needles accurately pierce into the adhesive block. Then, the fixture rotates to drive the adhesive block out of the hole and remove it. The peeling speed is 10mm / s. The peeling is considered complete when the force sensor detects that the peeling force is continuously lower than the debonding threshold. After peeling, transfer the instruments to deionized water for ultrasonic cleaning for 5 minutes, then rinse them three times with deionized water for 2 minutes each time. After drying with nitrogen, place the samples in a 60℃, 30Pa vacuum environment for drying for 30 minutes. Vacuum package them using light-proof aluminum foil material. 60 The desired finished product is obtained after irradiation sterilization at a Co dose of 35 kGy.

[0081] Compared to Example 1, this example reduces the residual adhesive detection and removal steps. The sample performance was characterized: the coating adhesion strength was tested using a universal testing machine, and the results showed an adhesion strength of 36.9 MPa, comparable to Example 1. Regarding biocompatibility, the CCK-8 assay was used to detect L929 fibroblast proliferation; after 5 days of co-culturing with the extract, the cell viability was approximately 62.4%, exhibiting significant cytotoxicity. Antibacterial performance was evaluated using the inhibition zone method (1 cm × 1 cm sample, Escherichia coli), and the inhibition zone area was approximately 3.05 cm². 2 The antibacterial properties were basically equivalent to those in Example 1. A canine bone implantation model was constructed, using a steel plate obtained by the method of this example but without silver plating inside the hole as the application form. When the locking screw was screwed into the bone through the steel plate, no coating peeling occurred. However, pathological sections 7 days after implantation still showed inflammation in the tissue around the screw, suggesting that residual glue might cause inflammation. A canine intramedullary infection model was further constructed. Bacterial smears 2 weeks after implantation showed that, compared to Comparative Example 1, there was basically no bacterial colony formation on the sample surface (silver-plated and un-silver-plated areas) and in the surrounding tissue fluid, indicating that the infection was effectively controlled. However, Micro-CT results showed that the bone integration effect was lower than that of the example.

[0082] Example 5

[0083] 1) Same as step 1) of Example 2, see simulation process. Figure 9 .

[0084] 2) The above samples were placed in an oil removal tank for oil removal. The solution formulation was 25 g / L sodium hydroxide, 12 g / L sodium carbonate, 12 g / L sodium metasilicate pentahydrate, 4 g / L fatty alcohol polyoxyethylene ether, 3 g / L sodium citrate, 2 g / L sodium polyacrylate, 0.8 g / L benzotriazole, with the remainder being deionized water. The samples were soaked in the solution at 55℃ and 150W ultrasonic power for 25 minutes, followed by rinsing with deionized water three times for 10 minutes each. After rinsing, the surface moisture was dried with nitrogen gas. The samples were then placed in a vacuum drying oven and dried at 60℃ and 30Pa vacuum for 10 minutes. After cooling to room temperature, the partitioned model was imported into a four-axis fully automatic dispensing machine. A four-eye industrial camera combined with a laser line scanner was used for 3D calibration and scanning of the screws to determine the spatial pose and partitioning. After the area model is registered and aligned, the uncoated area is automatically defined. High-temperature resistant masking adhesive DymaxSpeedMask®728-G (0.35% linear shrinkage) is applied in two stages: In the first stage, an L-shaped bent needle with an inner diameter of 80μm is used to outline the uncoated area boundary at 0.1MPa air pressure and 8mm / s speed, controlling the adhesive line width to approximately 100μm and covering all high-stress concentration areas. The boundary is then pre-cured for 3 seconds using a UV-LED point light source to lock it in place. In the second stage, a straight needle with an inner diameter of 200μm is used to fill the boundary area at 0.25MPa air pressure and 15mm / s speed, creating a second layer of adhesive film on the screw thread area, forming a continuous and uniform film with a wet film thickness of approximately 800μm. After all adhesive is applied, an irradiation device with a wavelength of 385nm and an irradiance of 100mW / cm² is used. 2 The UV-LED surface light source was exposed and cured for 8 minutes, then baked at 120℃ for 30 minutes and cooled in the oven. Visual inspection confirmed that the masking was complete.

[0085] 3) The above samples were subjected to dual plasma stripping. The specific process was as follows: the screws were immersed at room temperature in a stripping solution consisting of 60 g / L citric acid, 20 g / L ammonium fluoride, and 3 g / L imidazole for 150 seconds. After removal, the screws were rinsed with deionized water, dried with nitrogen, and vacuum dried. They were then transferred to a vacuum chamber and evacuated to 5 × 10⁻⁶. -3 The pressure was increased to Pa and heated to 150°C to desorb water vapor. A 3:1 argon-hydrogen mixture was introduced to maintain a working pressure of 3 Pa. A 200W RF power and a -80V negative bias were applied for cleaning for 20 minutes. Then, the hydrogen was stopped, the RF power was increased to 300W, and the negative bias was reduced to -150V. High-energy argon ion bombardment was performed for cleaning for 10 minutes. Immediately following, PVD silver was applied. The specific process involved moving the instrument into a vacuum chamber and evacuating it to a vacuum level of 5 × 10⁻⁶ Pa. -4 Pa, heated to 100℃, rotated at 10 r / min, injected with 45 sccm of argon gas to maintain 3.0 Pa, and subjected to argon ion bombardment with a -500V bias for 20 min; then maintained at a base vacuum of 5 × 10 - 4Under conditions of Pa, substrate temperature 100℃, and rotor speed 10r / min, using a DC power of 150W, a high-purity silver target was sputtered for 900s to obtain a silver transition layer of approximately 1μm. After cooling to room temperature, elemental silver was subsequently thickened using electrochemical deposition. The specific process parameters were: 32g / L silver nitrate, 85g / L 5,5-dimethylhydantoin, 75g / L potassium citrate, 15g / L potassium carbonate, 34.5g / L potassium hydroxide, and 28mg / L... 4,6-Dimethyl-2-mercaptopyrimidine, 1.2 g / L polyvinylpyrrolidone K30, 0.9 g / L 2,2'-bipyridine, and 0.7 g / L polyethylene glycol 2000 were used. The pH was adjusted to 11.5 with potassium hydroxide, and the solution was heated and kept constant at 38°C. Air agitation and continuous filtration of the plating solution were employed during electroplating. A 99.99% pure silver plate was used as the anode, and the sample as the cathode. Deposition was performed using a dual-pulse power supply with a forward pulse current density of 0.5 A / dm³. 2 Pulse width 5ms, duty cycle 25%; reverse pulse current density 0.2A / dm³ 2 With a pulse width of 3ms, a duty cycle of 10%, and a pulse frequency of 800Hz, a silver coating of approximately 5μm was obtained after 20 minutes of deposition.

[0086] 4) After removing the above-mentioned instrument samples from the electroplating tank, rinse them three times with deionized water for 3 minutes each time, dry them with nitrogen, and then place them in a 60°C forced-air drying environment for 30 minutes. After cooling to room temperature, manually fix the instrument horizontally onto a contour-following positioning fixture with a universal interface. The fixture can be adapted to the contour of the instrument to prevent bending and deformation. Then, start the semi-automatic peeling program. The system automatically identifies the inner and outer boundaries of the shielded area through vision and plans the peeling point and peeling path. After manually confirming the peeling angle (45°) and peeling speed (10mm / s) given by the system on the screen, the force-controlled flexible gripper automatically lifts the edge of the adhesive layer at an angle of about 90° and clamps the adhesive end. The fixture automatically drives the instrument to rotate and feed in a coordinated manner according to the pre-programmed path. The gripper continuously peels off the adhesive along the contour of the instrument at a constant speed preset by the system. At the same time, the ion air curtain is automatically turned on to eliminate static electricity and prevent adhesive residue from being sucked back. The force sensor detects that the peeling force is continuously lower than the debonding threshold and visual recognition confirms that there is no residual adhesive film in the shielded area, and then the peeling is determined. After stripping, the sample is transferred to an automated optical inspection station. A high-resolution industrial camera, combined with a multi-angle ring light source and ultraviolet-excited fluorescence imaging, is used to automatically scan the surface of the instrument to identify residual adhesive. After detection, the residual adhesive is cleaned online by a low-pressure plasma spray gun for localized ashing. Special structural areas are visually re-inspected under a 1200 Lux illuminance light source and then cleaned with plasma. The instrument is then transferred to deionized water for ultrasonic cleaning for 5 minutes, followed by rinsing three times with deionized water for 2 minutes each time. After drying with nitrogen, the sample is dried at 60℃ and 30Pa vacuum for 30 minutes. It is then vacuum-packed using light-proof aluminum foil. 60The desired finished product is obtained after irradiation sterilization at a Co dose of 35 kGy.

[0087] The embodiments described above are merely some preferred embodiments of the present invention, and are not intended to limit the invention. Those skilled in the art can make various changes and modifications without departing from the spirit and scope of the invention. Therefore, all technical solutions obtained by equivalent substitution or equivalent transformation fall within the protection scope of the present invention.

Claims

1. A method for preparing a bone implant device based on 3D dispensing and high-precision selective coating of a functional coating, characterized in that, Includes the following steps: 1) Based on 3D scanning, the titanium-based bone implant device to be coated is digitally reconstructed in three dimensions. Combined with finite element simulation analysis of the surface stress distribution under the service state of the device, the high-stress uncoated area with stress higher than the preset threshold and the low-stress coated area with stress not higher than the preset threshold are divided to obtain a stress partitioning model. 2) After degreasing the instrument substrate, a panoramic 3D dispensing, progressive UV curing, and baking process is performed on the uncoated area using a high-temperature UV-curable adhesive to form a stable masking layer. This masking layer completely covers the high-stress uncoated area and its boundaries, or extends further outwards to maintain a safety margin. The high-temperature UV-curable adhesive has a temperature resistance of not less than 130℃, is acid and alkali resistant, and has a linear shrinkage rate ≤0.5%. The 3D dispensing process is a two-stage operation: the first stage is high-precision edge dispensing, using a needle with an inner diameter of 60-100μm, applying the adhesive along the boundary of the uncoated area or moving it outwards, followed by UV pre-curing for 2-5 seconds to lock the edge. The second stage is supplementary dispensing, using a needle with an inner diameter of 150-300μm to apply the adhesive in a filling dispensing operation within the locked boundary of the uncoated area. 3) After performing dual membrane removal on the obtained sample, a functional coating is deposited on the instrument surface using vapor deposition and / or electrochemical deposition techniques; the dual membrane removal includes a first-stage weak acid immersion membrane removal and a second-stage mixed plasma membrane removal and activation. 4) After removing the adhesive from the shielding layer, clean, dry, and sterilize by irradiation to obtain the finished bone implant device.

2. The method for preparing a bone implant device based on 3D dispensing and high-precision selective coating of a functional coating as described in claim 1, characterized in that, In step 1), after completing the three-dimensional modeling of the titanium-based bone implant device, the mechanical state of the device under actual use conditions is simulated, and the high-stress uncoated area and low-stress coated area are divided by the yield strength of the device substrate as the stress threshold. During the finite element analysis, the mesh is refined for holes and corner areas, and the stress distribution on the surface of the instrument substrate is solved separately. The stress concentration location is located based on the Mises equivalent stress cloud map.

3. The method for preparing a bone implant device based on 3D dispensing and high-precision selective coating of a functional coating as described in claim 1, characterized in that, Step 2) involves a two-stage 3D dispensing process: The first stage is high-precision edge dispensing, using a needle with an inner diameter of 60-100μm. Dispensing is done along the boundary of the uncoated area or after moving outwards, with an air pressure of 0.05-0.15MPa and a speed of 5-10mm / s. After tracing, UV pre-curing is performed for 2-5 seconds to lock the edge and set the shape. The second stage is supplementary dispensing, using a needle with an inner diameter of 150-300μm. Dispensing is done in the uncoated area with the locked boundary, with an air pressure of 0.15-0.40MPa and a speed of 10-20mm / s. The filling density and adhesive thickness are adjusted according to the shape of the instrument. After dispensing, the entire area is exposed to UV curing and then baked at 100-150℃ for 20-40 minutes.

4. The method for preparing a bone implant device based on 3D dispensing and high-precision selective coating of a functional coating as described in claim 1, characterized in that, In step 2), panoramic 3D vision is used to acquire the three-dimensional point cloud of the instrument surface. The three-dimensional point cloud is registered with the stress zoning model obtained in step 1), and the root mean square error of the registration is controlled to be ≤0.05mm. The uncoated area on the stress zoning model is expanded by a safety margin of 0.1-0.3mm to form a theoretical boundary, which is then mapped onto the instrument's three-dimensional point cloud as the target area that needs to be coated. Based on the defined target area for adhesive application, a dispensing path is generated and optimized, including the boundary tracing path and the internal filling path. During the boundary tracing dispensing process, position data is collected in real time and three-axis dynamic deviation compensation is performed to control the deviation between the adhesive line landing point of the target area boundary and the theoretical boundary to not exceed ±25μm.

5. The method for preparing a bone implant device based on 3D dispensing and high-precision selective coating of a functional coating as described in claim 1, characterized in that, Step 3) The first-stage weak acid immersion membrane removal involves immersing the sample in a weak acid stripping solution to remove the membrane. The stripping solution contains 50-80 g / L citric acid, 10-30 g / L ammonium fluoride, 1-5 g / L imidazole, and the remainder is deionized water. The dual-hybrid plasma film removal activation involves placing the sample in a vacuum chamber and evacuating it to a vacuum level better than 5 × 10⁻⁶. -3 For in-situ heating and desorption of water vapor, argon and hydrogen are introduced at a volume ratio of 1:1-10:1, and the working pressure is adjusted to 1.5-8 Pa. An RF power supply is applied to the electrodes with an excitation power of 100-300 W, and a negative bias voltage of -50 to -100 V is applied to the sample to generate mixed plasma for cleaning. Hydrogen gas intake is stopped, while maintaining the argon flow rate and plasma excitation state. The RF power is increased to 200-400 W, and the negative bias voltage is increased to -100 to -200 V, utilizing high-energy Ar... + The sample is subjected to secondary bombardment with ions to remove the film and activate it.

6. The method for preparing a bone implant device based on 3D dispensing and high-precision selective coating of a functional coating as described in claim 1, characterized in that, The functional coating includes an antibacterial coating formed from one or more of gold, platinum, palladium, zinc, silver, and copper.

7. The method for preparing a bone implant device based on 3D dispensing and high-precision selective coating of a functional coating as described in claim 1, characterized in that, The adhesive removal process described in step 4) includes: removing the adhesive from the masking layer located on the outer surface of the instrument using a force-controlled semi-automatic peeling process; removing the adhesive from the masking layer located in the holes, grooves, or tubes of the instrument using a steel needle piercing and unscrewing method, and detecting residual adhesive after removal.

8. The method for preparing a bone implant device based on 3D dispensing and high-precision selective coating of a functional coating as described in claim 7, characterized in that, For the removal of the adhesive layer on the outer surface of the instrument, a semi-automatic force-controlled peeling process based on a robotic arm is used. This process includes: installing a gripper at the end of the robotic arm, with a torque sensor between them; using a contour-following multi-point flexible fixture to fix the instrument; utilizing the fluorescent properties of UV adhesive combined with a vision system to identify the adhesive layer; selecting the peeling starting point based on the curvature of the adhesive layer; and controlling the robotic arm to execute a pre-planned peeling path. During the peeling process, an ion curtain is activated to eliminate static electricity. At the same time, the torque sensor collects the peeling resistance torque in real time. Combining the reference torque and the vision system, the process automatically determines four working conditions: normal peeling, adhesive adhesion, adhesive breakage, and peeling completion.

9. The method for preparing a bone implant device based on 3D dispensing and high-precision selective coating of a functional coating as described in claim 7, characterized in that, For the internal adhesive layer of instrument holes, grooves, and tubular structures, a steel needle puncture and unscrewing method is used to remove it. The hole position is located by visual algorithm, and 2-6 steel needles with a diameter of less than 0.8mm are inserted into the shielding layer inside the hole. The reaction force is monitored in real time during the puncture process. The clamping mechanism of each steel needle rotates in the same direction at a speed of 0.5-2r / s, while the tooling retracts along the hole axis at a speed of 2-5mm / s, forming a combined unscrewing and pulling motion to complete the adhesive removal.

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