Bio-functional stent system driven by dual-mode printing

Abstract

The invention discloses a biological functional scaffold system driven by dual-mode printing, relates to the technical field of biomedicine, and is used for providing more accurate control on the aspects of porosity, cell attachment and surface modification. By integrating two advanced manufacturing technologies of 3D printing and aerosol spraying, the porosity and surface characteristics of the stent can be accurately controlled in the same printing process, and the cell attachment and proliferation environment is optimized. The cooperative working mechanism greatly improves the biocompatibility and mechanical strength of the biological scaffold, and further effectively promotes the tissue regeneration and repair efficiency. The whole manufacturing process is more efficient and accurate due to introduction of the control unit. The control unit automatically adjusts the printing speed and the spraying pressure based on real-time monitoring feedback, the uniformity and stability of the support are ensured, the error rate in the production process is reduced, and therefore the consistency and reliability of products are improved.

Description

Technical Field

[0001] The invention relates to the field of biomedical technology, in particular to a dual-mode printing-driven biological functional stent system. Background Art

[0002] In recent years, the rapid development of biomedical technology has made tissue engineering an important part of regenerative medicine. As the core component of tissue engineering, bioscaffolds provide cells with the necessary physical support and microenvironment to promote cell growth, proliferation and tissue regeneration. However, traditional materials used to manufacture bioscaffolds, such as polymers, ceramics and metals, have many limitations in biocompatibility, mechanical properties and surface characteristics. These deficiencies often lead to poor cell attachment or slow growth, thus affecting the effect of tissue regeneration.

[0003] Existing methods for manufacturing bioscaffolds mainly include traditional 3D printing, mold forming, casting or machining technology, but these methods have major defects in fine control. For example, single 3D printing technology is usually difficult to accurately control the porosity of the scaffold, and performs poorly in the process of surface functionalization. Although aerosol spray technology can improve the uniformity and adhesion of the coating, it still faces challenges in meeting the needs of personalized medicine, such as the difficulty in achieving customized production of specific designs and performance. This makes it difficult for current manufacturing technologies to adapt to the growing demand for personalized medicine.

[0004] In this context, plasma technology has gradually attracted attention. With its excellent surface modification ability, it is expected to overcome the shortcomings of traditional materials in hydrophilicity and biocompatibility. The combination of aerosol spraying and 3D printing technology provides the possibility of improving the surface properties and internal structure of the scaffold, making it possible to optimize the porosity, cell adhesion and surface function. Summary of the invention

[0005] The purpose of the present invention is to provide a dual-mode printing-driven biofunctional scaffold system integrating 3D printing and aerosol spraying, which provides more precise control over porosity, cell attachment and surface modification through the synergistic work of spraying and printing.

[0006] The technical solution adopted by the present invention to solve its technical problems is: a dual-mode printing-driven biofunctional scaffold system, including an advanced additive manufacturing module, a real-time monitoring and feedback regulation module, a safety and waste treatment module, and an intelligent data analysis and optimization module; The advanced additive manufacturing module includes a dual-mode printer, a spray nozzle, a material preparation and storage unit, and a post-processing and curing unit. The dual-mode printer integrates 3D printing and aerosol spraying. The spray nozzle is used to evenly spray the treated biocompatible polymer. The material preparation and storage unit stores a variety of biocompatible materials and is equipped with mixing and preparation equipment. The post-processing and curing unit provides a curing environment for the sprayed stent. The real-time monitoring and feedback adjustment module includes a temperature and humidity sensor, a gas composition sensor and a control unit; the temperature and humidity sensor monitors the temperature and humidity of the operating environment in real time, the gas composition sensor monitors the gas composition during the production process, the control unit integrates a PLC or a microcontroller, the dual-mode printer and the spray nozzle work together through the control unit, and the control unit adjusts the printing speed and spray pressure according to real-time feedback; The safety and waste handling module includes a safety protection unit, a waste collection unit and a material recovery unit; the safety protection unit includes an emergency stop button and a safety alarm system, the waste collection unit is used to collect waste generated during the production process, and the material recovery unit processes and classifies recyclable materials; The intelligent data analysis and optimization module includes a data processing unit and a visualization interface; the data processing unit collects and processes data collected during the production process, and the visualization interface provides a user-friendly graphical interface to monitor various parameters of the production process in real time.

[0007] Furthermore, the advanced additive manufacturing module also includes a plasma generator, which generates low-temperature plasma to improve the surface properties of biological materials.

[0008] Furthermore, the advanced additive manufacturing module also includes an excitation electrode, which generates and stabilizes plasma.

[0009] Furthermore, the advanced additive manufacturing module also includes a gas flow unit, which controls the input and flow of gas.

[0010] Furthermore, the data processing unit has a built-in optimization algorithm based on machine learning principles to automatically analyze and optimize the production process.

[0011] The beneficial effects of the present invention are as follows: the present invention realizes a revolutionary improvement in the performance of the biological scaffold through the innovative dual-mode printing technology, and has significant technical effects. First, the present invention can accurately control the porosity and surface characteristics of the scaffold in the same printing process and optimize the cell attachment and proliferation environment by integrating two advanced manufacturing technologies, 3D printing and aerosol spraying. This collaborative working mechanism greatly improves the biocompatibility and mechanical strength of the biological scaffold, thereby effectively promoting the efficiency of tissue regeneration and repair. Secondly, the introduction of the control unit makes the entire manufacturing process more efficient and accurate. Based on real-time monitoring feedback, the control unit automatically adjusts the printing speed and spraying pressure to ensure the uniformity and stability of the scaffold, reduces the error rate in the production process, and thus improves the consistency and reliability of the product. This intelligent production method not only shortens the production cycle, but also reduces the manufacturing cost, and realizes an efficient and sustainable production model. In addition, the system's precise regulation of surface functionalization enables the surface of the biological scaffold to design a coating according to specific application requirements to achieve a combination of multiple biological functions. This customized solution provides strong support for personalized medicine, helps in applications in different clinical scenarios, and meets patients' specific biomedical needs. Finally, by rationally configuring key technical parameters, such as printing resolution, spraying pressure and coating thickness, the microstructure and macroscopic performance of the biological scaffold are fully optimized. This not only improves the biological activity and mechanical stability of the scaffold, but also improves the antibacterial ability of the coating and the reliability of long-term use, significantly reducing the risk of complications after implantation. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 It is a structural diagram of the present invention; Figure 2 It is a flow chart of the working method of the present invention. DETAILED DESCRIPTION

[0013] The dual-mode printing technology of the present invention combines 3D printing and aerosol spraying technologies, and utilizes the collaborative work of dual nozzles to achieve precise control of porosity, surface functionalization and cell attachment performance in the manufacture of biological scaffolds. Specifically, the 3D printing part is responsible for constructing the basic shape and internal structure of the scaffold, and accurately controlling the porosity of the scaffold to meet the needs of cell growth. The aerosol spraying part is used to evenly spray modified polymers on the surface of the scaffold to form a coating with specific functions. This dual-mode working method greatly improves the distribution accuracy of the material, so that the thickness of the material and the coating characteristics can be accurately controlled, thereby achieving functional surface modification and enhancing the overall performance of the biological scaffold.

[0014] In the present invention, the control unit works closely with other technical modules (such as material supply and spray nozzles) to ensure the synchronization of printing and spraying processes. Based on real-time feedback data, the control unit automatically adjusts the printing speed, spraying pressure and material supply to ensure the consistency and overall quality of the stent. When the sensor detects changes in environmental conditions, the control unit can respond quickly and adjust the spraying pressure to maintain the uniformity of the coating, or adjust the printing speed to adapt to different manufacturing requirements. Intelligent control not only improves production efficiency, but also ensures that various parameters in the stent manufacturing process are optimized.

[0015] The key parameters in dual-mode printing technology include printing resolution, spraying pressure and coating thickness. Among them, the printing resolution is set between 50-100 microns. High resolution can improve the details and surface quality of the scaffold and promote cell attachment and growth. The spraying pressure is usually set at 25-45 bar, and the appropriate spraying pressure can ensure the uniformity and adhesion of the coating. The coating thickness is generally controlled between 30-100 microns, and the appropriate thickness ensures that the surface modified layer has good biocompatibility and antibacterial properties. The reasonable setting and adjustment of these key parameters provide a scientific basis for the performance optimization of the scaffold and increase the operability and depth of the technical solution. Through these advanced control means and parameter configurations, the dual-mode printing technology of the present invention can effectively improve the manufacturing quality of biological scaffolds, meet the needs of personalized medicine, and promote the development of tissue engineering.

[0016] The structure and working principle of the dual-mode printing-driven biofunctional scaffold system of the present invention are described below in conjunction with the accompanying drawings.

[0017] like Figure 1 As shown, the dual-mode printing-driven biofunctional scaffold system includes an advanced additive manufacturing module, a real-time monitoring and feedback regulation module, a safety and waste disposal module, and an intelligent data analysis and optimization module. The structures of each part are described below.

[0018] 1. Advanced Additive Manufacturing Module: The advanced additive manufacturing module includes a dual-mode printer, a spray nozzle, a plasma generator, an excitation electrode, a gas flow unit, a material preparation and storage unit, and a post-processing and curing unit.

[0019] The dual-mode printer integrates 3D printing and aerosol spraying functions, and is equipped with dual nozzles to work together. By precisely controlling the spraying and printing process of the nozzles, the porosity, surface functionalization and cell attachment properties of the scaffold can be precisely controlled. Dual-mode printing can ensure uniform distribution of materials, thickness control and functionalized surface modification, which is significantly better than single traditional 3D printing or spraying technology.

[0020] The spray nozzle is used to evenly spray the treated biocompatible polymer to form a modified layer to improve the surface properties of the biological scaffold and ensure rapid curing of the coating while printing.

[0021] The plasma generator generates low-temperature plasma to improve the surface properties of biomaterials and provide optimal surface attachment conditions for subsequent aerosol spraying.

[0022] The excitation electrode generates and stabilizes the plasma to ensure optimal plasma treatment effects.

[0023] The gas flow unit controls the gas input and flow rate to ensure the consistency and stability of plasma generation, providing stable conditions for the surface treatment of the stent.

[0024] The material preparation and storage unit stores a variety of biocompatible materials and is equipped with mixing and preparation equipment to ensure the effectiveness and applicability of the materials. In addition, the intelligent supply system ensures that materials are provided on demand during the printing and spraying process.

[0025] The post-treatment and curing unit provides a curing environment for the sprayed stent to ensure the stability and adhesion of the polymer layer.

[0026] 2. Real-time monitoring and feedback adjustment module The real-time monitoring and feedback adjustment module includes a temperature and humidity sensor, a gas composition sensor and a control unit.

[0027] The temperature and humidity sensor monitors the temperature and humidity of the operating environment in real time to ensure optimal printing and coating conditions.

[0028] Gas composition sensors monitor gas composition during production, providing real-time feedback data to help optimize processing strategies.

[0029] The control unit integrates PLC or microcontroller, and the dual-mode printer and spray nozzle work together through the control unit to ensure the synchronization of printing and spraying. The control unit automatically adjusts the printing speed, spraying pressure and other parameters based on real-time feedback to ensure the overall quality and consistency of the entire bracket system and realize intelligent optimization of the manufacturing process.

[0030] 3. Safety and waste disposal module The safety and waste handling module includes a safety protection unit, a waste collection unit and a material recovery unit.

[0031] The safety protection unit includes an emergency stop button and a safety alarm system to ensure the safety of operators.

[0032] The waste collection unit is used to collect waste generated during the production process and keep the production environment clean.

[0033] The material recovery unit processes and sorts recyclable materials to reduce resource waste and support sustainable development.

[0034] 4. Intelligent Data Analysis and Optimization Module The intelligent data analysis and optimization module includes a data processing unit and a visualization interface.

[0035] The data processing unit collects and processes the data collected during the production process and generates real-time analysis reports to guide production optimization. The data processing unit has a built-in optimization algorithm, which is based on the principle of machine learning and automatically analyzes and optimizes the production process to improve production efficiency and product quality.

[0036] The visual interface provides a user-friendly graphical interface to monitor various parameters during the production process in real time.

[0037] Through the synergy and intelligent control of the above modules, the present invention can improve the efficiency, accuracy and consistency of stent manufacturing and provide a more reliable solution for personalized medicine.

[0038] The present invention achieves a revolutionary improvement in the performance of biological scaffolds through innovative dual-mode printing technology, and has significant technical effects. First, by integrating two advanced manufacturing technologies, 3D printing and aerosol spraying, the present invention can accurately control the porosity and surface properties of the scaffold in the same printing process, and optimize the cell attachment and proliferation environment. This collaborative working mechanism greatly improves the biocompatibility and mechanical strength of the biological scaffold, thereby effectively promoting the efficiency of tissue regeneration and repair. Secondly, the introduction of the control unit makes the entire manufacturing process more efficient and accurate. Based on real-time monitoring feedback, the control unit automatically adjusts the printing speed and spraying pressure to ensure the uniformity and stability of the scaffold, reduce the error rate in the production process, and thus improve the consistency and reliability of the product. This intelligent production method not only shortens the production cycle, but also reduces manufacturing costs, and realizes an efficient and sustainable production model. In addition, the system's precise regulation of surface functionalization enables the surface of the biological scaffold to design coatings according to specific application requirements to achieve a combination of multiple biological functions. This customized solution provides strong support for personalized medicine, helps to be used in different clinical scenarios, and meets the specific biomedical needs of patients. Finally, by rationally configuring key technical parameters, such as printing resolution, spraying pressure and coating thickness, the microstructure and macroscopic performance of the biological scaffold are fully optimized. This not only improves the biological activity and mechanical stability of the scaffold, but also improves the antibacterial ability of the coating and the reliability of long-term use, significantly reducing the risk of complications after implantation.

[0039] The technical effect of the present invention is incomparable to traditional manufacturing technology. Its innovative application in the manufacturing process of biological scaffolds has promoted the development of tissue engineering technology to a higher level, provided a more reliable and effective technical solution for the clinical application of regenerative medicine, and has broad market prospects and application value.

[0040] The present invention provides effective solutions to many key problems existing in the existing bio-scaffold manufacturing technology, specifically including the following aspects: 1. Insufficient biocompatibility Traditional scaffold materials, such as polymers, ceramics and metals, have limitations in biocompatibility, surface properties and cell adhesion, resulting in poor cell adhesion and slow growth. The present invention significantly improves the surface properties of the material, enhances its biocompatibility, and promotes cell activity and proliferation by integrating plasma treatment technology.

[0041] 2. Complexity and inefficiency of the manufacturing process Existing stent manufacturing methods mostly use traditional processes such as mold forming, casting or machining, which usually involve complex processes, high production costs and difficulty in mass production. The present invention uses dual-mode printing technology combined with aerosol spraying to simplify the production process, increase the manufacturing speed, and meet the needs of large-scale, personalized medical care.

[0042] 3. Difficulty in achieving personalized medical needs With the continuous development of personalized medicine, patients have an increasing demand for specific stent designs and performance, and traditional manufacturing technology is difficult to flexibly respond to such demands. The present invention uses dual-mode printing technology to flexibly adjust the printing structure, porosity and surface functionalization, achieving a higher level of customized production and better meeting the individual needs of patients.

[0043] 4. Insufficient surface functionalization Traditional manufacturing technology lacks effective control methods in the process of surface modification of biomaterials, and it is often difficult to achieve the desired functionalization effect. The present invention ensures the multifunctionality of the stent surface through precise control of dual-mode printing technology, combined with aerosol spraying and plasma treatment, and optimizes the performance of cell attachment, antibacterial properties and other biological properties.

[0044] 5. Lack of real-time monitoring and feedback The existing manufacturing process lacks effective real-time monitoring and feedback regulation, which easily leads to unstable production and low efficiency. The real-time monitoring and feedback regulation module of the present invention dynamically adjusts the production environment and parameters through intelligent control, ensuring the stability and efficiency of the manufacturing process, thereby improving the overall quality of the bioscaffold.

[0045] By specifically solving the above key problems, the present invention provides an innovative and effective method in the field of bioscaffold manufacturing, which not only promotes the development of tissue engineering technology, but also lays the foundation for the popularization of regenerative medicine in clinical applications.

[0046] The working principle and method of use of the dual-mode printing-driven biofunctional scaffold system of the present invention are described in detail below in conjunction with specific embodiments. Figure 2 As shown: 1. Material preparation and storage 1.1 Material selection Quantity and type: Determine the required biocompatible polymer, such as polylactic acid (PLA), and select the appropriate material type based on actual needs. Evaluate the specific needs of the application, such as the mechanical strength and biocompatibility of the scaffold.

[0047] Supplier confirmation: Select reliable material suppliers and ensure that the materials provided meet medical standards and technical specifications. Ask suppliers about the characteristics, safety and technical specifications of the materials.

[0048] 1.2 Storage and handling Storage conditions: Ensure that polymer materials are stored in an environment with appropriate temperature and good humidity control, avoiding high temperature and humidity, which can be set at 25°C ± 2°C and 40%-60% relative humidity. Store materials in sealed containers to prevent moisture absorption, such as moisture-proof bags or desiccant bags.

[0049] Material inspection: Before use, quality check the materials for visible contamination or damage. Check the shelf life and storage conditions of the materials to ensure that fresh materials are used.

[0050] 1.3 Preparation and mixing Material Proportion: If different types of polymers need to be mixed, determine the ratio of each component according to the design requirements. For example, the ratio of PLA to plasticizer or other biocompatible materials. Fully understand the physical properties of different materials, such as melt index MFI and viscosity, to ensure effective mixing.

[0051] Mixing equipment: Use appropriate mixing equipment, such as high-speed mixers and planetary mixers, to ensure that the materials are evenly mixed. During the mixing process, monitor the temperature and time to avoid overheating or uneven mixing of materials, which may cause changes in physical properties.

[0052] Post-mixing processing: After mixing, conduct a preliminary quality inspection to ensure that the viscosity and fluidity of the material meet the requirements of spraying or printing. Store the mixed material as needed and mark the use date and composition ratio to avoid mixing inappropriate materials.

[0053] 2. 3D Printing Process 2.1 Equipment Preparation Equipment inspection and cleaning: Before printing, conduct a comprehensive inspection of the 3D printer, including the nozzle, extruder, and printing platform. Ensure that all components are unobstructed and free of contamination. Use appropriate cleaning agents to clean the printing platform and nozzle to ensure that there are no impurities on the printing surface to improve adhesion.

[0054] Equipment calibration: Make sure the print platform is flat and properly calibrated to prevent layer-to-layer deviation during printing. Calibrate the nozzle height to avoid first layer failure or uneven printing due to improper height adjustment.

[0055] Material loading: Load the prepared biocompatible polymer material, such as PLA, into the printer's material feed port. Ensure that the material flows evenly and that there is enough material for the printing process.

[0056] 2.2 Setting Printing Parameters Select printing mode: Select the appropriate printing mode according to design requirements and material properties, such as FDM, SLA. Determine the printing speed of the bracket, usually set at 40-60mm / s to achieve better surface quality and printing accuracy.

[0057] Set layer thickness: Set the layer thickness according to the application requirements of the bracket design, such as 0.1mm to 0.3mm. Thinner layer thickness helps improve printing accuracy, but may increase printing time.

[0058] Filling ratio: Set the internal filling method, such as grid and honeycomb; and the filling ratio, such as 20%-100%, to balance the strength and material usage of the bracket.

[0059] Temperature setting: Set the appropriate nozzle temperature and printing platform temperature according to the type of polymer used. Usually the nozzle temperature of PLA is 190°C to 220°C and the platform temperature is 50°C.

[0060] 2.3 Execute the Print Operation Start the print task: Load the design file, such as an STL file, and start the print task through the printer's software interface. Make sure the computer and printer are well connected and can monitor the printing process in real time.

[0061] Real-time monitoring: During the printing process, the operator should observe the printing status and promptly identify possible problems, such as abnormal material flow and separation of layers. Record the time and material status used during the printing process for subsequent analysis.

[0062] Finish the print: Once the print is complete, wait for the nozzle to cool down and then you can safely remove the bracket. Inspect the printed bracket to confirm there are no obvious defects or damage, and measure key dimensions to ensure it meets the design requirements.

[0063] 3. Plasma treatment 3.1 Equipment and material preparation Equipment inspection: Ensure that the plasma generator is in good working condition. Check the generator connections, gas pipelines and power supply to ensure there are no leaks and damage. Check the surface condition of the excitation electrode to ensure that it is not contaminated and can effectively generate plasma.

[0064] Environmental preparation: Adjust the temperature and humidity of the processing chamber to ensure that plasma processing is carried out within the ideal range. The operating environment should be kept dry to avoid moisture affecting the generation of plasma.

[0065] Material preparation: Gently place the freshly printed stent into the processing area of ​​the plasma treatment unit, ensuring that the stent is free of contamination and in a proper position, facing the electrode.

[0066] 3.2 Starting the plasma generator Set working parameters: Set the working frequency of the plasma generator according to the material type, such as 2.4-5 GHz; set the power, such as 500W, and the specific parameters need to be selected according to the characteristics of the polymer. Under the control of the gas flow unit, select an inert gas, such as nitrogen or argon, and set an appropriate flow rate to ensure stable plasma generation. Usually the flow rate is set at 50-100 sccm.

[0067] Startup and Monitoring: Start the plasma generator and observe the equipment instruments to ensure stable plasma generation. Observe the color and light intensity of the plasma to confirm its normal operation.

[0068] 3.3 Processing time and environmental monitoring Treatment time setting: Set the treatment time of the material, generally in the range of 5-10 minutes. For different polymers, the treatment time is slightly different to achieve the best surface modification effect. The stability of the plasma should be checked regularly during the treatment process, and the airflow or power setting can be adjusted in time if abnormalities are found.

[0069] Real-time monitoring: During the treatment process, use temperature and humidity sensors to monitor the temperature and humidity of the treatment environment to ensure that they are at optimal levels. Monitor gas composition to ensure that no harmful gases are generated during the treatment process, targeting high-risk gases such as ozone. Set up independent monitoring and alarm mechanisms.

[0070] 3.4 Post-processing steps End of treatment: After the treatment time is over, safely turn off the plasma generator and wait for the equipment to cool down. Carefully remove the stent from the treatment area, using gloves to ensure safe operation and prevent the stent surface from being contaminated.

[0071] Treatment quality check: Visually check the surface quality of the plasma treated stents to see if they have a uniform gloss and that no areas have been missed. Log the treatment parameters, such as time and power settings, for reference during subsequent data analysis.

[0072] 4. Spraying process 4.1 Spraying equipment preparation Equipment inspection: Check the aerosol nozzle to ensure that it is not blocked or damaged, and the nozzle outlet should be clean and free of impurities.

[0073] Ensure that the aerosol spray system is well connected and the air source is connected reliably.

[0074] Material preparation: Can the plasma treated biocompatible polymer, such as PLA, and reconfirm its fluidity and dilution to be suitable for spraying. Check the quality of the material to ensure that it has no precipitation and meets the spraying requirements.

[0075] 4.2 Spraying parameter settings Spraying mode selection: Select the appropriate spraying mode according to the design requirements, such as mist spraying and flat spraying. Different modes will affect the uniformity and performance of the coating.

[0076] Set spraying parameters: Set the spraying pressure, usually between 2-5 bar, and adjust to the optimal spraying pressure according to the characteristics of the polymer. Set the spraying angle and distance to ensure uniform spraying. Generally, the nozzle is kept 150-300 mm away from the bracket surface.

[0077] Coating thickness control: Set the coating thickness for each spray, usually set to 40 microns, ensuring that multiple sprays can be used to achieve the required total thickness.

[0078] 4.3 Perform spraying operation Start the spraying equipment: Start the aerosol nozzle, conduct a trial spray, test the spraying on the screen to ensure that the spraying parameters are set accurately, and observe the uniformity and spray quality of the spray.

[0079] Spray process monitoring: The plasma treated stent is fixed in the spray area to ensure stability and no tilting. During the spray process, the operator should maintain a certain movement speed to avoid material accumulation and inconsistent coating.

[0080] Spraying operation: When starting to spray, first spray from the edge of the bracket, clockwise or counterclockwise, gradually move toward the center to ensure that the coating is evenly covered from the edge to the center.

[0081] Check spray thickness and uniformity regularly, make adjustments if necessary and repeat spraying to ensure target thickness is achieved.

[0082] 4.4 Post-spraying treatment After spraying: Immediately turn off the spray equipment and wait for the material to flow freely. Carefully remove any residual material with appropriate tools to avoid affecting the appearance quality after curing.

[0083] Thickness and uniformity check: Use a thickness gauge on the finished stent to measure the actual thickness of the coating and perform a uniformity test to ensure that the coating meets the expected standards.

[0084] Record spraying parameters, completion time and other key information to provide a basis for data analysis.

[0085] 5. Curing and post-processing 5.1 Curing equipment settings Equipment preparation: Ensure that the curing room is clean and dust-free and the equipment is operating normally. If UV-curing materials are used, check whether the UV lamp is functioning normally and ensure that the UV intensity meets the requirements, such as 100-300 mW / cm².

[0086] Temperature and humidity control: Set the temperature and humidity of the curing chamber to ensure that the curing process is carried out under optimal conditions. Typically, the temperature range is set between 20°C and 25°C, and the humidity is controlled between 40%-60%.

[0087] Curing time setting: Select the appropriate curing time according to the coating material. For example, if it is a UV curing material, set a specific curing time, usually 30 seconds to 3 minutes. It depends on the material thickness and equipment specifications.

[0088] 5.2 Execute the curing process Stent transfer: Carefully move the sprayed stent into the curing chamber to avoid affecting the integrity of the coating during the process.

[0089] Start the curing equipment: Start the curing equipment to ensure normal operation of the equipment. For UV materials, ensure that the UV lamp is on and regularly check the working status of the lamp to avoid damage or uneven curing effect.

[0090] Observe the curing status: During the curing process, the operator should regularly check the surface condition of the bracket to observe whether there are any abnormal phenomena such as bubbles, over-curing or color changes. Ensure that the light source and distance are properly distributed to ensure a good curing effect.

[0091] 5.3 Quality Check After curing is completed: After curing is completed, allow the bracket to cool naturally to room temperature in the curing chamber to avoid material stress cracks caused by rapid temperature changes.

[0092] Check the curing effect: Check the quality of the cured stent and observe the uniformity, adhesion, strength and surface flatness of the surface coating. Use a hardness tester to test the hardness of the coating to ensure that it meets the expected standards.

[0093] Adhesion Testing: Perform simple adhesion tests, such as a tape pull test, to confirm that the coating-to-substrate adhesion meets design requirements, such as ASTM D3359.

[0094] Record data: Record all data and quality test results of the curing process, including temperature, humidity, curing time and any observed problems, to provide reference for subsequent production optimization.

[0095] 6. Real-time monitoring and feedback adjustment 6.1 Start the monitoring system Equipment startup: Start the real-time monitoring system, including temperature and humidity sensors and gas composition sensors. Make sure all sensors are connected and working properly.

[0096] Sensor Calibration: Before monitoring, calibrate all sensors to ensure accuracy. Perform calibration checks according to the equipment manual and verify with calibration standards when necessary.

[0097] Monitoring software configuration: Use monitoring software, such as PLC control interface, to configure the sensor database and interface. Connect the real-time data of the sensor to the system to achieve real-time monitoring and display of data.

[0098] 6.2 Data Capture and Processing Data collection: Use temperature and humidity sensors to monitor the temperature and humidity of the printing and spraying environment in real time. Continuously collect this data and ensure that the data is updated at an appropriate frequency, such as once every 5 seconds.

[0099] Gas composition monitoring: Use gas composition sensors to monitor possible gas components in the production environment, such as ozone and nitrogen concentrations, to ensure that no harmful gases are present during the processing. When the safety threshold is exceeded, the system automatically issues an alarm.

[0100] Data logging and storage: Record real-time data in files to create a database of ongoing records for later analysis and optimization. Ensure data can be retrieved by timeline and by sensor.

[0101] 6.3 Feedback and Adjustment Automatic adjustment function: Based on the data fed back by the sensor, the controller automatically adjusts the operating status of the equipment. For example, if the humidity exceeds the set range, start the dehumidification equipment or adjust the air flow. If the temperature deviates from the ideal range, start the heating or cooling device.

[0102] Real-time operator alerts: Set alarm thresholds in the monitoring system. When temperature, humidity or gas composition exceeds the set value, the system will alert the operator and display abnormal information. Operators should respond to the alarm in a timely manner and make adjustments based on actual conditions, such as reducing the spray rate or restarting the equipment.

[0103] Data analysis and feedback decision-making: Regularly analyze monitoring data to identify potential problems in the production process. Use data analysis tools to evaluate data trends and identify factors that may affect product quality. Based on the data analysis results, make corresponding operational recommendations, such as adjusting material ratios and optimizing environmental conditions, to improve production quality.

[0104] 7. Data Analysis and Optimization 7.1 Data Analysis Data collection: Real-time data collected from the real-time monitoring and feedback adjustment module, including temperature, humidity, gas composition, spraying parameters and printing performance, will be regularly imported into the intelligent data analysis and optimization module. Ensure that the stored data is complete and traceable, and the data format should be unified to facilitate subsequent processing and analysis.

[0105] Data preprocessing: Preprocess the collected data, including removing outliers, such as fault data, and filling missing values, such as data loss. Mark data in specific time periods for segmented analysis, such as production peak periods and equipment maintenance periods.

[0106] Statistical analysis: Use statistical tools, such as data processing libraries in R or Python, to analyze basic statistics, such as mean, standard deviation, and trend lines, to assess the stability and volatility of data during production.

[0107] 7.2 Visualization report generation Data visualization tools: Use data visualization tools such as Tableau and Power BI to display data graphically and generate easy-to-understand charts and dashboards. Optimize the reporting interface to ensure that operators can intuitively understand data changes, trends, and potential risks.

[0108] Report content: The report should include key performance indicators (KPIs), such as output, defect rate, and material efficiency, to facilitate the evaluation of the performance of each link in the production process. The chart should show the temperature and humidity changes, the history of gas composition, and the changes in key parameters during the spraying process to facilitate cross-analysis.

[0109] Regular report generation: Set up a mechanism to automatically generate reports on a regular basis, such as daily, weekly or monthly, to help the management team understand the production status and make decisions. The reports should be distributed to relevant departments and managers in a timely manner to ensure that all stakeholders are aware of the production progress in a timely manner.

[0110] 7.3 Optimization suggestions and implementation Performance evaluation: After comprehensively analyzing all data, evaluate production performance and identify potential quality issues or efficiency bottlenecks. According to the data analysis results, formulate targeted optimization suggestions. For example, if it is found that the defect rate increases under specific operating conditions, consider adjusting the spraying formula or optimizing the equipment settings.

[0111] Feedback loop implementation: Feedback optimization suggestions into the production process for a continuous improvement cycle. Ensure that relevant operators are aware of the implemented changes and operate according to the new protocols. At the same time, continue to monitor and record performance based on new feedback.

[0112] Future continuous optimization plan: Set long-term optimization goals and regularly adjust production strategies and equipment update plans based on historical performance and market demand. Use machine learning algorithm training models to conduct predictive analysis and use the prediction results to improve resource allocation and production efficiency.

Claims

1. A dual-mode printing-driven biofunctional scaffold system, characterized in that: It includes advanced additive manufacturing module, real-time monitoring and feedback adjustment module, safety and waste treatment module and intelligent data analysis and optimization module; The advanced additive manufacturing module includes a dual-mode printer, a spray nozzle, a material preparation and storage unit, and a post-processing and curing unit. The dual-mode printer integrates 3D printing and aerosol spraying. The spray nozzle is used to evenly spray the treated biocompatible polymer. The material preparation and storage unit stores a variety of biocompatible materials and is equipped with mixing and preparation equipment. The post-processing and curing unit provides a curing environment for the sprayed stent. The real-time monitoring and feedback adjustment module includes a temperature and humidity sensor, a gas composition sensor and a control unit; the temperature and humidity sensor monitors the temperature and humidity of the operating environment in real time, the gas composition sensor monitors the gas composition during the production process, the control unit integrates a PLC or a microcontroller, the dual-mode printer and the spray nozzle work together through the control unit, and the control unit adjusts the printing speed and spray pressure according to real-time feedback; The safety and waste handling module includes a safety protection unit, a waste collection unit and a material recovery unit; the safety protection unit includes an emergency stop button and a safety alarm system, the waste collection unit is used to collect waste generated during the production process, and the material recovery unit processes and classifies recyclable materials; The intelligent data analysis and optimization module includes a data processing unit and a visualization interface; the data processing unit collects and processes data collected during the production process, and the visualization interface provides a user-friendly graphical interface to monitor various parameters of the production process in real time.

2. The dual-mode printing-driven biofunctional scaffold system according to claim 1, characterized in that: The advanced additive manufacturing module also includes a plasma generator that generates low-temperature plasma to improve the surface properties of biological materials.

3. The dual-mode printing-driven biofunctional scaffold system according to claim 2, characterized in that: The advanced additive manufacturing module also includes an excitation electrode that generates and stabilizes plasma.

4. The dual-mode printing-driven biofunctional scaffold system according to claim 3, characterized in that: The advanced additive manufacturing module further includes a gas flow unit, which controls the input and flow of gas.

5. The dual-mode printing-driven biofunctional scaffold system according to claim 4, characterized in that: The data processing unit has a built-in optimization algorithm based on machine learning principles to automatically analyze and optimize the production process.

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