Intelligent integrated system for manufacturing biological tissue engineering scaffold

Abstract

The invention discloses an intelligent integrated system for manufacturing a biological tissue engineering scaffold, relates to the technical field of biomedicine, and is used for improving the biocompatibility, mechanical strength and cell adhesion capacity of a biological scaffold. The plasma generator comprises a microwave generator, a precise electrode and an efficient gas flowing unit; the integrated manufacturing module comprises a 3D printing unit, a plasma enhanced chemical vapor deposition (PECVD) unit and a cooperative control unit; the monitoring and control system comprises an intelligent temperature and humidity sensor, a gas component monitor and an automatic control unit; the data management and optimization module comprises a biological safety evaluation unit, a personalized design and simulation unit, a material selection and management unit, a degradable material processing unit and a dynamic feedback and adjustment unit. According to the invention, low-temperature plasma treatment, 3D printing and PECVD technologies are fused, and a highly intelligent and integrated manufacturing platform is constructed.

Description

Technical Field

[0001] The invention relates to the technical field of biomedicine, in particular to an intelligent integrated system for manufacturing biological tissue engineering scaffolds. Background Art

[0002] With the rapid development of regenerative medicine and tissue engineering technology, bioscaffolds have received extensive attention as key components to support cell growth and promote tissue regeneration. Although traditional bioscaffold materials such as polymers, metals and ceramics have achieved certain success in certain applications, they still face a series of technical challenges in terms of biocompatibility, mechanical strength and degradation rate. Summary of the invention

[0003] The purpose of the present invention is to provide an intelligent integrated system for manufacturing biological tissue engineering scaffolds, which is used to improve the biocompatibility, mechanical strength and cell adhesion ability of biological scaffolds, thereby meeting the growing demand for tissue regeneration materials in modern medicine.

[0004] The technical solution adopted by the present invention to solve the technical problem is: an intelligent integrated system for manufacturing biological tissue engineering scaffolds, including a plasma generator, an integrated manufacturing module, a monitoring and control module, a data management and optimization module, a safety and maintenance module, and a user interaction and feedback module;

[0005] The plasma generator includes a microwave generator, a precision electrode and a high-efficiency gas flow unit, wherein the microwave generator is used to generate stable low-temperature plasma, the precision electrode is used to ensure stable generation and discharge efficiency of plasma, and the high-efficiency gas flow unit includes a pipeline and a valve to adjust the gas flow;

[0006] The integrated manufacturing module includes a 3D printing unit, a plasma enhanced chemical vapor deposition (PECVD) unit and a coordinated control unit; the 3D printing unit is used to manufacture the stent, the plasma enhanced chemical vapor deposition (PECVD) unit is used to uniformly coat the biocompatible polymer, and the coordinated control unit integrates the monitoring and control of the 3D printing and coating deposition processes;

[0007] The monitoring and control module includes an intelligent temperature and humidity sensor, a gas composition monitor and an automatic control unit; the intelligent temperature and humidity sensor monitors the temperature and humidity of the production environment in real time, the gas composition monitor monitors the changes in gas composition, and the automatic control unit integrates PLC and microcontroller to automatically adjust the status of each module according to sensor data, thereby improving the stability and intelligence of the system;

[0008] The data management and optimization module includes a biosafety assessment unit, a personalized design and simulation unit, a material selection and management unit, a degradable material processing unit and a dynamic feedback and adjustment unit; the biosafety assessment unit is responsible for evaluating the biocompatibility of the stent material and the production process, the personalized design and simulation unit designs the stent according to the patient's characteristics, and performs performance prediction and optimizes the stent structure through computer simulation, the material selection and management unit manages the selection and procurement process of biomaterials, the degradable material processing unit processes degradable biomaterials, and the dynamic feedback and adjustment unit analyzes production data in real time;

[0009] The safety and maintenance module includes a safety monitoring unit and a maintenance and service unit. The safety monitoring unit monitors the equipment status and process parameters in real time, and the maintenance and service unit monitors the health status of the equipment.

[0010] The user interaction and feedback module includes a user interaction interface and a comprehensive analysis and feedback unit. The user interaction interface is used for operators to manage and monitor the production process, and the comprehensive analysis and feedback unit continuously optimizes the manufacturing process through a feedback mechanism.

[0011] Furthermore, it also includes a long-term data storage module, which is used to receive data transmitted from the plasma generator, integrated manufacturing module, monitoring and control module, data management and optimization module, safety and maintenance module, and user interaction and feedback module.

[0012] The beneficial effects of the present invention are as follows: the present invention realizes the efficient manufacturing of biological scaffolds by integrating low-temperature plasma treatment, 3D printing and PECVD technology, improves its biocompatibility, mechanical strength and cell adhesion ability, and meets the needs of modern medicine for tissue regeneration. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 It is a structural diagram of the integrated system of the present invention.

[0014] Figure 2 It is a working method diagram of the present invention. DETAILED DESCRIPTION

[0015] The main purpose of the present invention is to achieve the following specific objectives by developing an intelligent integrated system for manufacturing biological tissue engineering scaffolds:

[0016] (1) Improving biocompatibility: Plasma enhanced chemical vapor deposition (PECVD) is used to attach high-performance films to the surface of biological tissue engineering scaffolds to improve the surface properties of biological scaffold materials, increase their hydrophilicity and biological activity, and promote cell attachment, proliferation and tissue regeneration.

[0017] (2) Personalized design: With the help of high-precision 3D printing technology, we can design and manufacture stent structures that meet the patient's physiological characteristics and functional requirements based on their specific needs, providing personalized medical solutions.

[0018] (3) Enhance the performance of tissue engineering scaffolds: After 3D printing the scaffold, the scaffold is first modified by plasma surface treatment to introduce active functional groups to improve the surface properties, laying the foundation for subsequent plasma enhanced chemical vapor deposition (PECVD). Then, silicon nitride, silicon dioxide or polymer-based films are deposited on the surface of the scaffold using plasma enhanced chemical vapor deposition (PECVD). These films can improve the surface hardness, wear resistance and chemical stability of the scaffold, thereby enhancing its mechanical properties and ensuring the safe application of the scaffold in vivo.

[0019] (4) Optimize production efficiency: Through intelligent monitoring and control systems, real-time monitoring and adjustment of production environment and parameters can be achieved, thereby improving the efficiency and consistency of the stent manufacturing process and reducing production costs and time.

[0020] (5) Ensure product quality: Integrate biosafety assessment and quality inspection modules to ensure that the final product strictly meets clinical standards in terms of biosafety and expected performance.

[0021] The present invention forms an interdisciplinary and collaborative advanced manufacturing platform by highly integrating low-temperature plasma surface treatment technology, precision 3D printing technology, plasma enhanced chemical vapor deposition (PECVD) coating technology, and real-time environmental monitoring and control systems, aiming to effectively meet the increasingly severe challenges and requirements of modern medicine for tissue regeneration.

[0022] In the present invention, low-temperature plasma treatment technology, as a cutting-edge surface modification method, plays a vital role in the manufacture of biological scaffolds. Low-temperature plasma treatment technology effectively cleans and disinfects the scaffold by generating abundant active species, removing pollutants and microorganisms attached to the surface. This cleaning process ensures that the tissue functional engineering scaffold meets higher biosafety standards before being used for subsequent processing, significantly reducing the risk of bacterial infection. The composite plasma treatment also significantly improves the hydrophilicity and activity of the material surface by introducing a variety of functional groups, such as hydroxyl, carboxyl and amino groups, and provides higher chemical adhesion, ensuring the subsequent plasma enhanced chemical vapor deposition PECVD coating on the scaffold surface. Strong adhesion. Subsequently, the 3D printed tissue engineering scaffold effectively improves the biocompatibility, antibacterial property, chemical stability and mechanical strength of the scaffold by introducing corresponding functional groups and uniformly depositing high-precision polymer films during the plasma enhanced chemical vapor deposition PECVD coating process. Strict control of the process ensures the consistency and standardization of the coating, significantly enhancing the stability and performance of the scaffold in the biological environment.

[0023] The present invention uses intelligent monitoring and control technology to achieve real-time data collection and dynamic adjustment of the entire production process, ensuring that the process is operated under the optimal temperature, humidity and gas composition conditions, while the data analysis and feedback mechanism in this process provides a strong guarantee for the efficiency and stability of the system operation. The deep integration of all these technologies not only improves the overall performance of the bioscaffold, but also provides an efficient and safe manufacturing solution for personalized medical applications.

[0024] The structure and working method of the intelligent integrated system of the present invention are described in detail below with reference to the accompanying drawings. Figure 1 As shown, the intelligent integrated system of the present invention includes a plasma generator, an integrated manufacturing module, a monitoring and control module, a data management and optimization module, a safety and maintenance module, a user interaction and feedback module and a long-term data storage module.

[0025] 1. Plasma Generator

[0026] The plasma generator includes a microwave generator, precision electrodes and a high-efficiency gas flow unit.

[0027] Microwave generator: used to generate stable low-temperature plasma, with adjustable frequency and power characteristics to meet the processing requirements of different materials.

[0028] Precision electrodes: used to ensure stable generation and discharge efficiency of plasma, thereby improving the treatment effect on the surface of biological materials.

[0029] High-efficiency gas flow unit: Consists of pipes and valves to precisely regulate gas flow to ensure consistent plasma generation and maximize active ingredients.

[0030] 2. Integrated Manufacturing Module

[0031] The integrated manufacturing module includes a 3D printing unit, a plasma enhanced chemical vapor deposition (PECVD) unit and a collaborative control unit.

[0032] 3D printing unit: Using high-precision 3D printing technology, flexible design and manufacturing of stent structures can meet the personalized needs of patients and realize complex biomaterial structures.

[0033] Plasma Enhanced Chemical Vapor Deposition (PECVD) Unit: used to uniformly coat biocompatible polymers to enhance the functionality of the stent and provide additional physical and chemical protection.

[0034] Collaborative control unit: Integrates monitoring and control of the 3D printing and coating deposition processes to ensure seamless collaboration and precise regulation.

[0035] 3. Monitoring and control module

[0036] The monitoring and control module includes intelligent temperature and humidity sensors, gas composition monitors and automatic control units.

[0037] Smart temperature and humidity sensor: real-time monitoring of the temperature and humidity of the production environment to ensure manufacturing under optimal conditions.

[0038] Gas composition monitor: monitors changes in gas composition to ensure gas quality during processing and reduce potential risks.

[0039] Automation control unit: integrated PLC and microcontroller, automatically adjust the status of each module according to sensor data, and improve the stability and intelligence of the system.

[0040] 4. Data Management and Optimization Module

[0041] The data management and optimization module includes a biosafety assessment unit, a personalized design and simulation unit, a material selection and management unit, a degradable material processing unit, and a dynamic feedback and adjustment unit.

[0042] Biosafety Assessment Unit: Responsible for evaluating the biocompatibility of stent materials and production processes to ensure compliance with medical standards.

[0043] Personalized Design and Simulation Unit: allows users to design stents based on patient characteristics and perform performance prediction through computer simulation to optimize stent structure.

[0044] Material Selection and Management Unit: Manages the selection and procurement process of biological materials, ensuring that the sources of materials meet biocompatibility and safety standards.

[0045] Degradable Materials Processing Unit: Focuses on processing degradable biomaterials to ensure that their degradation process in the body is as expected and promotes tissue regeneration.

[0046] Dynamic feedback and adjustment unit: Analyze production data in real time and make adjustments based on feedback to ensure the stability of the production process and the optimization of parameters.

[0047] 5. Security and Maintenance Module

[0048] The safety and maintenance module includes a safety monitoring unit and a maintenance and service unit.

[0049] Safety monitoring unit: monitors equipment status and process parameters in real time to ensure production safety.

[0050] Maintenance and service unit: monitors the health status of equipment, promptly prompts maintenance needs, and reduces equipment failure rate.

[0051] 6. User Interaction and Feedback Module

[0052] The user interaction and feedback module includes a user interaction interface and a comprehensive analysis and feedback unit.

[0053] User Interaction Interface: It has an intuitive and easy-to-use operation interface, which is convenient for operators to manage and monitor the production process.

[0054] Comprehensive analysis and feedback unit: Integrate quality inspection results with production data, continuously optimize manufacturing processes through feedback mechanisms, and improve product consistency.

[0055] 7. Long-term data storage module

[0056] The long-term data storage module is used to receive data transmitted from the plasma generator, the integrated manufacturing module, the monitoring and control module, the data management and optimization module, the safety and maintenance module, and the user interaction and feedback module.

[0057] The working method of the present invention is described below:

[0058] S1. System startup and material preparation

[0059] S1.1. Start the system and initialize the settings

[0060] Before starting the system, conduct a comprehensive check of the connections and status of all equipment, including the plasma generator, 3D printing unit, and plasma enhanced chemical vapor deposition (PECVD) unit. Ensure that all power and gas pipelines are connected properly, and perform necessary checks on monitoring components, such as temperature and humidity sensors and gas composition monitors, to ensure that the equipment can provide accurate real-time data. Subsequently, activate the integrated control module, enter the operator credentials through the user interface, enter the system interface, perform a system self-check, and confirm that all modules are in normal working condition for subsequent parameter settings.

[0061] In the parameter initialization stage, the basic operating parameters are set according to the production type and the biomaterial used, such as: the operating frequency of the plasma generator, usually set at 2.45 GHz; the power, usually set at 500W; the printing speed of the 3D printing unit, usually set at 20 mm / s -40 mm / s; the layer thickness, usually set at 0.1 mm -0.3 mm; the nozzle temperature, set at 190°C -220°C. The gas flow rate of the plasma enhanced chemical vapor deposition PECVD unit is set at 10sccm-30sccm; the deposition time is set at 20 minutes-60 minutes. The system provides a confirmation interface for parameter settings to prevent misoperation.

[0062] S1.2. Material selection and preparation

[0063] According to specific bioengineering needs and patient-specific conditions, select appropriate biomaterials, such as polylactic acid (PLA) and polyurethane. Through the material selection and management unit, ensure that the source of the material meets the biocompatibility standards and meets the needs of biomedical applications. During the material preparation stage, the selected biomaterials are visually inspected to ensure that there is no contamination and no obvious defects. If necessary, perform preliminary surface treatment, such as low-temperature plasma pretreatment, to enhance subsequent processing performance. In addition, all biomaterials should be stored in a constant temperature and humidity environment to avoid changes in material properties due to environmental changes.

[0064] S1.3. Equipment configuration and debugging

[0065] The plasma generator, 3D printing unit, and plasma enhanced chemical vapor deposition (PECVD) unit are rationally configured according to the production process to ensure that the gas and power pipelines are connected correctly and reach the optimal operating position. During the debugging and verification process, the plasma generator is initially turned on, and the operating frequency and power are set, and the status of the electrodes is checked to ensure that plasma can be effectively generated. At the same time, the equipment is tested for dry operation through the collaborative control unit to ensure that the efficient gas flow unit is unobstructed and the functional status of each sensor is monitored in real time. If conditions permit, a period of pressure resistance test is carried out to ensure that the equipment remains stable and safe at the required pressure.

[0066] S2. Bracket Forming

[0067] S2.1. Start the 3D printing unit

[0068] According to the patient's needs and combined with pre-set parameters, the personalized design and simulation unit generates a 3D design file of the target stent. Verify the correctness of the design file, including size, structure and porosity, to ensure that it meets the biological function requirements. Then, upload the generated 3D design file to the 3D printing unit and confirm the printing parameters such as nozzle temperature, printing speed and layer thickness in the user interface.

[0069] During the initial printing phase, the 3D printing unit is turned on and a self-check procedure is performed to ensure that the multi-track throat, nozzle and motion system of the equipment are in normal condition. At the same time, the material filling status is verified to ensure that there is sufficient printing material in the hopper to avoid material shortage during printing.

[0070] S2.2. Monitoring and adjustment of printing process

[0071] After starting the printing program, the 3D printing unit will print the bioscaffold layer by layer according to the set path and parameters. The printing nozzle of the 3D printing unit heats the material to the set extrusion temperature to ensure that the material flows evenly and adheres well to the printing base. The printing quality is monitored in real time, and the temperature and humidity of the environment are monitored through intelligent temperature and humidity sensors to ensure good material adaptability. If problems are found during the printing process, such as poor material flow, abnormal temperature, and nozzle clogging, the operator will adjust the printing parameters immediately through the collaborative control unit and record key performance parameters to provide a basis for subsequent optimization.

[0072] S2.3. Processing after printing

[0073] After printing is completed, the system will send a signal to prompt the 3D printing unit to automatically stop. The operator needs to confirm the printing status through the user interface to ensure that there are no abnormal problems with the bracket. After that, the printed bracket is allowed to cool naturally to room temperature in a dedicated cooling area to avoid deformation caused by thermal stress. At the same time, the completed bracket is preliminarily inspected to check whether the appearance, size and structure meet the design requirements, and pay attention to the uniformity of porosity and wall thickness. If defects are found, they need to be recorded and analyzed in a timely manner, and corresponding improvement measures should be formulated to improve future printing quality.

[0074] S3, plasma surface treatment

[0075] S3.1. Start the plasma generator

[0076] Confirm the input parameter settings on the user interface and click the start button. The system will perform a self-check to ensure that the microwave generator and precision electrodes are working properly and that the efficient gas flow unit is unobstructed. In the gas flow adjustment stage, set the gas flow and mixing ratio and introduce the selected inert gas, such as nitrogen or argon. This process is managed by the efficient gas flow unit, and its flow rate and pressure are monitored in real time to ensure that the inert gas flow is maintained within the set range to ensure stable plasma generation.

[0077] S3.2. Surface treatment process of tissue engineering scaffolds

[0078] Using a fixture or stage, safely and accurately place the tissue engineering scaffold to be treated, such as a polylactic acid scaffold, in the working area of ​​the plasma generator to ensure that the material is fully exposed to the plasma source. During the plasma treatment, the treatment time is recorded, which is usually set to 5 to 15 minutes to achieve the best surface modification effect. The plasma will generate active species such as free radicals, hydroxyl groups and oxygen atoms. This process can not only improve the hydrophilicity of the surface of the tissue engineering scaffold and enhance the adhesion of the subsequent PECVD coating, but also effectively remove surface contaminants to ensure that the material meets the requirements of subsequent processes.

[0079] S3.3. Parameter monitoring after plasma treatment

[0080] During the treatment process, a temperature and humidity sensor is used to monitor the temperature and humidity of the working environment in real time to ensure that the material is treated under ideal conditions. The gas quality during the plasma generation process is monitored by a gas composition monitor to ensure that the active components of the generated plasma are sufficient and stable. After the treatment is completed, a contact angle meter is used to check the hydrophilicity changes of the material to ensure the successful introduction of the expected functional groups, and the status and environmental parameters of the plasma treatment are recorded to provide a basis for subsequent optimization and analysis.

[0081] S3.4. Safety and emergency response

[0082] During the entire process, the safety monitoring unit is activated to continuously track the equipment status and environmental changes. If an abnormality occurs, such as excessive temperature or gas leakage, the system will immediately sound an alarm and automatically shut down. At the same time, the operator must be familiar with the emergency handling procedures to ensure that necessary measures can be taken quickly in the event of equipment failure, gas leakage and other emergencies, such as cutting off the power supply and opening the ventilation system to reduce potential risks.

[0083] S4. PECVD coating deposition

[0084] S4.1 Start up the plasma enhanced chemical vapor deposition (PECVD) unit

[0085] Carefully place the surface treated tissue engineering scaffold into the PECVD deposition chamber of the PECVD unit and ensure that the tissue engineering scaffold is fixed at the gas inlet to ensure uniform exposure to the deposition agent. Confirm the PECVD deposition parameter settings in the user interface, including the selection of gas types such as silane, ammonia or other organic precursors and their mixing ratios. Start the PECVD unit and ensure a steady flow of gas into the deposition chamber to maintain uniform deposition conditions.

[0086] S4.2. Coating deposition parameter setting and control

[0087] According to the required coating thickness, usually set to 20-50 microns, the deposition time is set in the plasma enhanced chemical vapor deposition PECVD unit. The system should have a real-time feedback mechanism to dynamically adjust the deposition time based on the film adhesion evolution data during the deposition process to ensure the uniformity and adhesion of the film. At the same time, the temperature in the deposition chamber is monitored in real time to ensure that it is adapted to the required process conditions, and the intelligent temperature control system automatically adjusts the temperature increase or decrease to maintain the optimal coating formation environment.

[0088] S4.3. Quality monitoring during coating deposition

[0089] During the PECVD coating deposition process, a variety of sensors are used to monitor key performance parameters, including film thickness, gas composition and flow rate. The dynamic feedback and adjustment unit will adjust the operating parameters in real time when necessary to ensure that the film quality meets expectations. After deposition is completed, a surface analyzer, such as a scanning electron microscope or a contact angle meter, is used to conduct a comprehensive inspection of the coating to evaluate its uniformity and adhesion to ensure that the biocompatibility, antibacterial properties and other performance indicators of the film meet the design requirements. At the same time, key data throughout the deposition process, such as pressure, gas composition and film thickness, are recorded and stored in a long-term data storage module to provide data support for subsequent process optimization.

[0090] S5. Monitoring and Adjustment

[0091] S5.1. Real-time monitoring of environmental parameters

[0092] During the entire manufacturing process, the intelligent temperature and humidity sensor is activated to monitor the temperature and relative humidity of the printing chamber and PECVD deposition chamber in real time. All monitoring data will be displayed on the user interface, which is convenient for the operator to intuitively grasp the changes in environmental parameters. At the same time, the gas composition monitor is activated to analyze the composition and concentration of the gas in real time to ensure that the inert gas and active species remain within the set range. During the PECVD process, the chemical composition of the gas is continuously monitored so that the gas flow and composition can be adjusted when necessary to optimize the coating quality.

[0093] S5.2. System control and regulation

[0094] The integrated automation control unit dynamically adjusts the operating parameters of each device based on sensor feedback to ensure operation under optimal conditions. Specifically, the automation control unit adjusts the printer's nozzle temperature and printing speed based on real-time data to adapt to environmental changes. During the PECVD coating process, the gas flow rate and deposition time are automatically adjusted based on real-time data on gas composition and film thickness to ensure the quality and functionality of the film.

[0095] S5.3. Data visualization and operation interface

[0096] On the user interface, a dynamic dashboard function is provided to display key parameters monitored in real time, such as temperature, humidity, coating thickness and gas composition, to help operators quickly identify abnormalities and take corresponding measures. In addition, all monitoring data will be recorded and stored in the long-term data storage module to provide a basis for subsequent process optimization and quality control to ensure stability and reliability.

[0097] S6. Biosafety and Quality Assessment

[0098] S6.1. Implementation of Biosafety Assessment

[0099] According to international standards such as ISO 10993, comprehensive biocompatibility testing is carried out, including indicators such as cytotoxicity, allergy and irritation, to evaluate the safety of scaffold materials to organisms. At the same time, microbiological testing is carried out to evaluate the microbial load of the material throughout the production process to ensure that it meets sterility standards before biological application and uses appropriate disinfection or antiseptic treatment methods.

[0100] S6.2 Quality Control Testing and Feedback

[0101] The finished bioscaffolds are tested for structure and physical properties, including size, shape, consistency, and coating uniformity, thickness, and adhesion. Based on the evaluation results, the material selection and manufacturing process are optimized and adjusted in a timely manner to ensure that each batch of scaffolds meets strict quality standards. In the cell attachment and proliferation test, the growth state of the bioscaffolds after implantation into the cell culture system is observed, and the cell activity detection method is used to evaluate the promotion effect of the scaffolds on cells.

[0102] S7. Data analysis and feedback

[0103] S7.1. Data collection and storage

[0104] Throughout the manufacturing process, various monitoring components, such as intelligent temperature and humidity sensors and gas composition monitors, will continuously collect key data, which will be transmitted to the long-term data storage module to ensure accurate recording of all processing parameters and support subsequent process analysis and optimization.

[0105] S7.2. Data analysis and optimized decision making

[0106] Data analysis algorithms are used to conduct in-depth analysis of long-term monitoring data to identify key factors that affect the performance of bioscaffolds, such as the relationship between printing speed, coating thickness and cell attachment rate. Adjustment suggestions are made based on the analysis results to optimize printing parameters, improve coating materials or adjust production processes.

[0107] S7.3. User feedback and system improvement

[0108] After production is completed, operators can submit feedback through the user interface to record any problems or improvement opportunities during the production process. Customer feedback is collected regularly to optimize and upgrade the system to ensure that equipment and processes continue to adapt to changes in market demand and medical applications.

[0109] The technical effects achieved by the present invention are embodied in the following aspects:

[0110] Improved material properties: By combining plasma treatment and PECVD coating technology, the surface characteristics and mechanical properties of bioengineering scaffolds have been effectively improved, significantly enhancing the biocompatibility and antibacterial properties of bioengineering scaffolds, helping to promote cell attachment and proliferation, and providing an ideal microenvironment for tissue regeneration.

[0111] Personalization and flexibility: 3D printing technology can quickly manufacture personalized bioengineering scaffolds, shortening the production cycle of traditional processes to better meet the specific needs of patients.

[0112] Intelligent production process: Introduce intelligent monitoring and adjustment mechanisms to update and optimize production conditions and parameters in real time to improve the safety and efficiency of the manufacturing process.

[0113] Simplify the production process: The integrated system structure enables smooth connection of each manufacturing step, reducing human intervention and errors that may occur during the production process, thereby improving the reliability of overall production.

[0114] Enhance clinical application value: Ensure the safety of the final product in clinical applications by conducting biosafety and quality assessments to promote the further development of regenerative medicine and tissue engineering.

[0115] In summary, the present invention is expected to provide beneficial support for the manufacture of bioengineering scaffolds in the fields of regenerative medicine and tissue engineering by systematically integrating multiple advanced technologies.

[0116] The working method of the present invention is described below in conjunction with specific embodiments:

[0117] Example Purpose: To manufacture a polylactic acid (PLA) bioscaffold for soft tissue regeneration, ensuring good biocompatibility, suitable structure and mechanical properties.

[0118] S1. System startup and material preparation

[0119] S1.1. Start the system and initialize the settings

[0120] The operator turns on the switch in the control room and confirms that the remote screen saver system is released.

[0121] Enter the operator password in the user interface to enter the system control interface.

[0122] Perform the system self-check procedure to confirm that the plasma generator, 3D printing unit and plasma enhanced chemical vapor deposition (PECVD) unit are in normal working condition.

[0123] S1.2. Material selection and preparation

[0124] Polylactic acid (PLA) was selected as the biomaterial. The material selection and management unit confirmed that the PLA material came from a qualified supplier and met the biocompatibility standards.

[0125] The PLA pellets are checked and loaded into the 3D printing unit hopper to ensure that the material is free of impurities and has no excessive moisture content.

[0126] Store the materials in a constant temperature and humidity environment to avoid changes in material properties due to environmental factors.

[0127] S1.3. Equipment configuration and debugging

[0128] The equipment of the entire system is reasonably configured according to the work process to ensure that the gas pipeline is firmly connected to the power supply.

[0129] Turn on the plasma generator, set the frequency to 2.45 GHz, the power to 500 W and perform preliminary debugging.

[0130] Turn on the 3D printing unit and perform a dry run test to confirm that the material runout is stable.

[0131] S1.4. Operator Training

[0132] Operators attend training courses as planned to learn how to operate and maintain equipment, respond to emergencies such as gas leaks and equipment failures, and conduct simulated operation drills.

[0133] S2. Bracket Forming

[0134] S2.1. Start the 3D printing unit

[0135] Generate a 3D printing model according to the design requirements and upload it to the 3D printing unit.

[0136] The parameters of 3D printing were set as follows: nozzle temperature was 210°C and printing speed was 20 mm / s.

[0137] S2.2. Monitoring and adjustment of the printing process

[0138] Start the 3D printing unit to print the bracket, and monitor the temperature, humidity and printing quality in real time.

[0139] If you find any abnormal printing quality, such as poor material flow, adjust the parameters immediately to ensure that the bracket generation meets the design standards.

[0140] S2.3. Processing after printing

[0141] After printing is completed, let the bracket cool naturally in a constant temperature room and check whether its surface is smooth and meets the predetermined dimensions.

[0142] S3, plasma surface treatment

[0143] S3.1. Start the plasma generator

[0144] The operator starts the plasma generator after confirming the input operating parameters in the user interface.

[0145] The nitrogen flow rate is set by an efficient gas flow unit to ensure stable generation of low-temperature plasma.

[0146] S3.2. Surface treatment process of tissue engineering scaffolds

[0147] The PLA-based support was placed in the treatment area of ​​the plasma generator and fixed.

[0148] The plasma treatment time was set to 10 minutes, and the environmental parameters were monitored during the treatment.

[0149] S3.3. Parameter monitoring after plasma treatment

[0150] The monitoring and control module checks the temperature and humidity in real time and ensures that the gas composition meets the standards. After treatment, the hydrophilicity of the stent is evaluated using a contact angle meter to witness the increase in surface activity.

[0151] S3.4. Safety and emergency response

[0152] The safety monitoring unit is activated to ensure safety during plasma processing. If an abnormality occurs, the equipment will automatically stop and an alarm will be sounded.

[0153] S4. PECVD coating deposition

[0154] S4.1. Start the plasma enhanced chemical vapor deposition (PECVD) unit

[0155] The surface treated stent was placed into the PECVD deposition chamber and the gas flow was started.

[0156] Set the gas composition and ratio to ensure that the gas flows as required during the deposition process.

[0157] S4.2. Coating deposition parameter setting and control

[0158] Start the PECVD deposition process, adjust the deposition temperature to 40 °C, set the deposition time to 30 min, and ensure the uniformity of the coating.

[0159] S4.3. Quality monitoring during coating deposition

[0160] Monitor film thickness and gas composition changes to ensure quality is as expected, and complete quality inspection at the end.

[0161] S5. Monitoring and Adjustment

[0162] S5.1. Real-time monitoring of environmental parameters

[0163] Intelligent temperature and humidity sensors and gas composition monitors are activated to provide real-time data feedback throughout the production process.

[0164] S5.2. System control and regulation

[0165] Based on the collected data, the operating parameters of the 3D printing unit and plasma enhanced chemical vapor deposition (PECVD) unit are adjusted in real time to maintain the optimal working state, further improving the stability of the production process.

[0166] S5.3. Data visualization and operation interface

[0167] Environmental monitoring data and production status are displayed in real time on the user interface for easy operator monitoring.

[0168] S6. Biosafety and Quality Assessment

[0169] S6.1. Implementation of Biosafety Assessment

[0170] Conduct biocompatibility experiments and take samples to test indicators such as the cytotoxicity and biodegradability of the stent to ensure compliance.

[0171] S6.2 Quality Control Testing and Feedback

[0172] Physical performance tests were performed on the final stent to evaluate its adaptability and stability in the biomedical environment.

[0173] S7. Data analysis and feedback

[0174] S7.1. Data collection and storage

[0175] Data during the entire process, such as temperature, humidity, coating thickness, and cell attachment test results, are stored in a long-term data storage system for subsequent analysis.

[0176] S7.2. Data analysis and optimized decision making

[0177] Use the collected data to create trend analysis reports, identify key factors affecting stent production, and develop optimized production standards.

[0178] S7.3. User feedback and system improvement

[0179] Collect operator and customer feedback and make necessary adjustments to production processes to continuously improve product quality and production efficiency.

[0180] The present invention provides an intelligent integrated system for manufacturing biological tissue engineering scaffolds, which integrates low-temperature plasma treatment technology, precision 3D printing and plasma enhanced chemical vapor deposition (PECVD) technology to build a highly intelligent and integrated manufacturing platform. The biocompatibility and cell adhesion of scaffold materials are significantly improved by cutting-edge surface modification methods. By introducing a variety of active functional groups on the surface of the scaffold, the subsequent coating process is optimized to provide a superior microenvironment for cell growth and tissue regeneration. The core of the system lies in the seamless collaboration between its multi-technical modules, and each module is monitored and dynamically adjusted in real time through intelligent control to ensure that the various parameters in the production process are optimally configured. Precision 3D printing realizes a highly customized design based on the individual needs of patients. Low-temperature plasma treatment effectively disinfects the tissue engineering scaffolds after 3D printing and improves the surface performance of the scaffolds, forming good interface interactions and bonding forces with the subsequent PECVD coating, and the PECVD coating improves the biocompatibility and antibacterial properties of the tissue engineering scaffolds while ensuring the high-strength adhesion of the coating. This innovative manufacturing method not only significantly improves the mechanical strength and bioadaptability of the tissue engineering scaffolds, but also greatly shortens the production cycle and improves the overall manufacturing efficiency. The integrated solution demonstrated by the present invention has shown certain application potential in the fields of regenerative medicine and personalized medicine, can provide new ideas for the development and application of biomaterials, and contribute to the further development of the field of biomedical engineering.

Claims

1. An intelligent integrated system for manufacturing biological tissue engineering scaffolds, characterized in that: It includes plasma generator, integrated manufacturing module, monitoring and control module and data management and optimization module; The plasma generator includes a microwave generator for generating stable low-temperature plasma, a precision electrode for ensuring stable generation of plasma, and a high-efficiency gas flow unit for regulating gas flow; The integrated manufacturing module includes a 3D printing unit for manufacturing the stent, a plasma enhanced chemical vapor deposition (PECVD) unit for uniformly coating the biocompatible polymer, and a coordinated control unit; the coordinated control unit integrates the monitoring and control of the 3D printing and coating deposition processes; The monitoring and control module includes an intelligent temperature and humidity sensor for real-time monitoring of the temperature and humidity of the production environment, a gas composition monitor for monitoring changes in gas composition, and an automatic control unit; the automatic control unit integrates a PLC and a microcontroller to automatically adjust the working status of each module according to the sensor data; The data management and optimization module includes a biosafety assessment unit and a material selection and management unit; the biosafety assessment unit is used to assess the biocompatibility of the scaffold material and the production process, and the material selection and management unit manages the selection and procurement process of the biomaterial.

2. The intelligent integrated system for manufacturing biological tissue engineering scaffolds according to claim 1, characterized in that: The high-efficiency gas flow unit includes a pipeline and a valve.

3. The intelligent integrated system for manufacturing biological tissue engineering scaffolds according to claim 2, characterized in that: The data management and optimization module also includes a personalized design and simulation unit, which designs the stent according to the patient's characteristics, and performs performance prediction through computer simulation to optimize the stent structure.

4. The intelligent integrated system for manufacturing biological tissue engineering scaffolds according to claim 3, characterized in that: The data management and optimization module also includes a degradable material processing unit for processing degradable biological materials.

5. The intelligent integrated system for manufacturing biological tissue engineering scaffolds according to claim 4, characterized in that: The data management and optimization module also includes a dynamic feedback and adjustment unit for real-time analysis of production data.

6. The intelligent integrated system for manufacturing biological tissue engineering scaffolds according to claim 5, characterized in that: It also includes a safety and maintenance module, which includes a safety monitoring unit and a maintenance and service unit. The safety monitoring unit monitors the equipment status and process parameters in real time, and the maintenance and service unit monitors the health status of the equipment.

7. The intelligent integrated system for manufacturing biological tissue engineering scaffolds according to claim 6, characterized in that: It also includes a user interaction and feedback module, which includes a user interaction interface and a comprehensive analysis and feedback unit. The user interaction interface is used for operators to manage and monitor the production process, and the comprehensive analysis and feedback unit continuously optimizes the manufacturing process through a feedback mechanism.

8. The intelligent integrated system for manufacturing biological tissue engineering scaffolds according to claim 7, characterized in that: It also includes a long-term data storage module, which is used to receive data transmitted from the plasma generator, the integrated manufacturing module, the monitoring and control module, the data management and optimization module, the safety and maintenance module, and the user interaction and feedback module.

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