Flexible manufacturing decision-making method and system for three-dimensional ultrasonic imaging catheter

Abstract

The invention discloses a flexible manufacturing decision-making method and system for a three-dimensional ultrasonic imaging catheter, and relates to the technical field of medical equipment, and the method comprises the steps: building a patient ultrasonic imaging catheter demand model; performing adaptive demand analysis through the demand model to obtain demand parameters of the ultrasonic imaging catheter of the patient; the method comprises the following steps: performing multi-module disassembly on a three-dimensional ultrasonic imaging catheter according to the manufacturing requirement of the ultrasonic catheter to obtain a plurality of catheter structure modules; based on the patient demand parameters, manufacturing scheme modular design is conducted on the structure module, and finally the manufacturing scheme of the target catheter module is obtained; and carrying out conduit manufacturing analogue simulation to obtain related simulation parameters, and optimizing a manufacturing scheme according to the parameters to complete a flexible manufacturing decision. The technical problem that in the prior art, a customized three-dimensional ultrasonic imaging catheter cannot be accurately designed and manufactured according to individual requirements of patients and clinical scenes is solved, and the technical effect of accurately designing and manufacturing the customized three-dimensional ultrasonic imaging catheter is achieved.

Description

Technical Field

[0001] The present application relates to the field of medical equipment technology, and in particular to a flexible manufacturing decision method and system for three-dimensional ultrasound imaging catheters. Background Art

[0002] With the continuous advancement of ultrasound imaging technology, three-dimensional ultrasound imaging has gradually become an important diagnostic tool in clinical practice. However, traditional ultrasound imaging catheters are mostly universal designs and have not been optimized according to the individual needs of patients, resulting in limited effectiveness in imaging examinations of some special cases (such as complex heart disease, vascular lesions, etc.). Although there are some flexible manufacturing technologies, solutions for the personalized design and manufacturing of three-dimensional ultrasound imaging catheters are still relatively scarce. Existing methods cannot fully consider the patient's anatomical structure and clinical needs, resulting in limitations in the accuracy and flexibility of ultrasound catheters. Therefore, how to design and manufacture customized three-dimensional ultrasound imaging catheters based on the individual characteristics of patients and clinical application scenarios has become a key technical issue that needs to be urgently solved in this field.

[0003] At present, there is a technical problem in the relevant technologies that it is impossible to accurately design and manufacture customized three-dimensional ultrasound imaging catheters according to the patient's personalized needs and clinical scenarios. Summary of the invention

[0004] The present application solves the technical problem in the prior art that it is impossible to accurately design and manufacture customized three-dimensional ultrasound imaging catheters according to the individual needs of patients and clinical scenarios by providing a flexible manufacturing decision method and system for three-dimensional ultrasound imaging catheters.

[0005] The present application provides a flexible manufacturing decision method for a three-dimensional ultrasound imaging catheter, including: A patient ultrasound imaging catheter demand model is established, and the individualized feature data and clinical application scenario information of the target patient are collected and acquired at the same time; based on the patient ultrasound imaging catheter demand model, an adaptive demand analysis is performed on the individualized feature data and clinical application scenario information of the target patient to obtain the patient ultrasound imaging catheter demand parameters; according to the ultrasound catheter manufacturing requirements, the component structure information of the three-dimensional ultrasound imaging catheter is disassembled into multiple modules to obtain N ultrasound imaging catheter structure modules; based on the patient ultrasound imaging catheter demand parameters, the manufacturing scheme of the N ultrasound imaging catheter structure modules is modularly designed in turn to obtain the target ultrasound catheter module manufacturing scheme; the target ultrasound catheter module manufacturing scheme is simulated by catheter manufacturing to obtain catheter manufacturing simulation parameters, and the target ultrasound catheter module manufacturing scheme is optimized and flexible manufacturing decisions are made based on the catheter manufacturing simulation parameters.

[0006] The present application provides a flexible manufacturing decision system for a three-dimensional ultrasound imaging catheter, including: A requirements model construction module, which is used to establish a requirements model for a patient's ultrasonic imaging catheter, and simultaneously collect and obtain the individual characteristic data and clinical application scenario information of the target patient; an adaptive requirements analysis module, which is used to perform adaptive requirements analysis on the individual characteristic data and clinical application scenario information of the target patient based on the requirements model of the patient's ultrasonic imaging catheter to obtain the requirements parameters of the patient's ultrasonic imaging catheter; a multi-module disassembly module, which is used to perform multi-module disassembly on the composition structure information of the three-dimensional ultrasonic imaging catheter according to the manufacturing requirements of the ultrasonic catheter to obtain N ultrasonic imaging catheter structure modules; a manufacturing plan acquisition module, which is used to perform modular design of the manufacturing plan on the N ultrasonic imaging catheter structure modules in sequence based on the requirements parameters of the patient's ultrasonic imaging catheter to obtain the manufacturing plan of the target ultrasonic catheter module; a catheter manufacturing simulation parameter acquisition module, which is used to perform catheter manufacturing simulation on the manufacturing plan of the target ultrasonic catheter module to obtain catheter manufacturing simulation parameters, and perform design optimization and flexible manufacturing decision-making on the manufacturing plan of the target ultrasonic catheter module based on the catheter manufacturing simulation parameters.

[0007] It is intended to propose a flexible manufacturing decision-making method and system for a three-dimensional ultrasonic imaging catheter through this application. First, a requirements model for a patient's ultrasonic imaging catheter is established, and the individual characteristic data and clinical application scenario information of the target patient are collected; through this requirements model, adaptive requirements analysis is performed to obtain the requirements parameters of the patient's ultrasonic imaging catheter; according to the manufacturing requirements of the ultrasonic catheter, the three-dimensional ultrasonic imaging catheter is disassembled into multiple modules to obtain multiple catheter structure modules; based on the patient's requirements parameters, modular design of the manufacturing plan is performed on these structure modules, and finally the manufacturing plan of the target catheter module is obtained; catheter manufacturing simulation is performed to obtain relevant simulation parameters, and the manufacturing plan is optimized according to these parameters to complete the flexible manufacturing decision-making. By establishing a requirements model for a patient's ultrasonic imaging catheter and combining the individual characteristic data and clinical application scenario information of the patient, the technical effect of accurately designing and customizing the three-dimensional ultrasonic imaging catheter is achieved. Brief Description of the Drawings

[0008] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments of the present disclosure will be briefly introduced below. Flowcharts are used in this application to illustrate the operations performed by the system according to the embodiments of the present application. It should be understood that the operations described above or below do not necessarily need to be executed precisely in sequence. On the contrary, according to the need, they can be executed in reverse order or simultaneously. At the same time, other operations can also be added to these processes, or one or more operations can be removed from these processes.

[0009] Figure 1Schematic flowchart of the flexible manufacturing decision-making method for a three-dimensional ultrasonic imaging catheter provided by an embodiment of the present application; Figure 2 Schematic structural diagram of the flexible manufacturing decision-making system for a three-dimensional ultrasonic imaging catheter provided by an embodiment of the present application.

[0010] Explanation of reference numerals: Requirement model construction module 10, Adaptive requirement analysis module 20, Multi-module disassembly module 30, Manufacturing plan acquisition module 40, Catheter manufacturing simulation parameter acquisition module 50. Detailed implementation manners

[0011] The above description is only an overview of the technical solution of the present application. In order to be able to understand the technical means of the present application more clearly, it can be implemented according to the content of the description. And in order to make the above and other purposes, features and advantages of the present application more obvious and understandable, the following specifically gives the detailed implementation manners of the present application.

[0012] In order to make the purpose, technical solution and advantages of the present application clearer, the present application will be further described in detail below with reference to the accompanying drawings. The described embodiments should not be regarded as limitations of the present application. All other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the scope of protection of the present application.

[0013] In the following description, "some embodiments" are involved, which describe a subset of all possible embodiments. However, it can be understood that "some embodiments" can be the same subset or different subsets of all possible embodiments, and can be combined with each other without conflict. The terms "first / second" involved are only used to distinguish similar objects and do not represent a specific order for the objects. The terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusion. For example, a process, method, system, product or server including a series of steps or units does not necessarily limit to those steps or units clearly listed, but may include other steps or modules not clearly listed or inherent to these processes, methods, products or devices. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field of the present application. The terms used herein are only for the purpose of describing the embodiments of the present application.

[0014] An embodiment of the present application provides a flexible manufacturing decision-making method for a three-dimensional ultrasonic imaging catheter, as Figure 1 shown, the method includes: Step S100: Establish a demand model for the patient's ultrasonic imaging catheter, and simultaneously collect and obtain the individualized characteristic data and clinical application scenario information of the target patient. Specifically, to make the ultrasonic imaging catheter more in line with the patient's needs, it is necessary to start from two aspects: establishing a demand model and collecting data of the target patient. First, collect a regional patient data set, covering individualized characteristic data such as patient age, gender, and basic disease history, clinical application scenario information such as surgical type, surgical environment, and patient position, as well as application feedback data of previous three-dimensional ultrasonic imaging catheters. Use clustering analysis algorithms to process these data, group similar characteristic data into one category, use the patient characteristic data cluster as the input variable, and the catheter application data as the output variable, and adopt machine learning methods such as regression models and neural network models to establish a demand model for the patient's ultrasonic imaging catheter. For the target patient, use medical imaging equipment to accurately measure the individualized characteristic data such as the size and shape of the organ to be detected, understand the clinical application scenario information such as the surgical process, doctor requirements, and operating room equipment configuration, and integrate and organize them in the same data format as the modeling for subsequent input into the demand model for analysis. Combining the architecture characteristics of the two-dimensional probe with ASIC in the 4D_ICE technology, analyze how to integrate it into the design of the ultrasonic imaging catheter when establishing the model and collecting data. For example, when designing the ultrasonic transducer module, draw on the multi-element integration method to improve the imaging performance.

[0015] In a possible implementation, a demand model for a patient's ultrasound imaging catheter is established, and at the same time, individualized characteristic data and clinical application scenario information of the target patient are collected. Step S100 further includes step S110 of collecting a regional patient dataset, where the regional patient dataset includes patient individualized characteristic data, clinical application scenario information, and corresponding three-dimensional ultrasound imaging catheter application data. Specifically, to build a comprehensive and practical research foundation for patient ultrasound imaging catheters, it is crucial to fully collect the regional patient dataset. In terms of collecting patient individualized characteristic data, basic physiological information such as age, gender, height, and weight needs to be recorded because the body structures and functions of patients of different ages and genders are different, and body size also affects ultrasound imaging. The past medical history and medication use, such as heart disease and diabetes, should be carefully inquired, and at the same time, technologies such as CT and MRI are used to accurately measure the anatomical structure of the organ to be detected. The collection of clinical application scenario information covers surgery-related information, such as clarifying the type of surgery, expected duration, special operation requirements, measuring the room temperature and humidity during the surgery, evaluating electromagnetic interference, determining the patient's body position. These factors have different requirements for the performance and usage methods of the ultrasound imaging catheter. The collection of three-dimensional ultrasound imaging catheter application data focuses on imaging performance data, such as resolution, contrast, frame rate, operation performance data, including insertion smoothness, manipulation flexibility, and instrument compatibility, as well as durability and stability data, that is, the performance changes after multiple uses and the stability in different environments. When collecting, the 4D_ICE technology can be referred to, paying attention to the performance of its two-dimensional probe with the ASIC architecture under high frame rate imaging, and the impact of the multi-element integration method on imaging resolution and signal processing ability, providing more valuable data support for subsequent analysis.

[0016] Step S120: Perform cluster analysis on the patient's individualized characteristic data and clinical application scenario information to obtain the clustering result of the patient characteristic data. Specifically, cluster analysis can mine similar data sets from the patient's individualized characteristic data and clinical application scenario information, helping to establish a demand model for the patient's ultrasonic imaging catheter. During implementation, first perform data preprocessing, comprehensively check the collected data, remove error values, and handle missing values using methods such as filling with mean, median, or machine learning prediction. Then standardize the data using methods such as Z-score to avoid the influence of magnitude differences on the analysis. Next, select a clustering algorithm, understand the characteristics of algorithms such as K-Means and hierarchical clustering. K-Means is efficient and suitable for large-scale data but requires a preset number of clusters. Hierarchical clustering can display hierarchical relationships but is computationally complex. Determine the algorithm based on the data scale, estimation of the number of clusters, etc., or try and compare multiple algorithms. Then determine the clustering features, select key factors such as age, gender, disease history, etc. from the patient's individualized characteristics, and select key factors such as surgical type, environmental factors, patient position, etc. from the clinical scenarios. Finally, perform cluster analysis. Taking K-Means as an example, set the number of clusters K and the maximum number of iterations according to experience or preliminary exploration. Input the preprocessed data into the algorithm, first randomly select the initial cluster centers, calculate the distances between the data points and the centers and assign them, recalculate the centers and reassign them, and iterate repeatedly until convergence. Evaluate the results using indicators such as the silhouette coefficient, and select the optimal K value and clustering result. The entire process can refer to the technical characteristics of 4D_ICE, consider the association between its imaging effect and patient characteristics, and incorporate them into the cluster analysis to make the results better reflect the demand differences of patients for ultrasonic imaging catheters based on this technology.

[0017] Step S130: Determine multiple patient characteristic data clusters according to the clustering result of the patient characteristic data. Specifically, determining the patient characteristic data clusters is the key to in-depth analysis of patient needs, which is carried out closely following the clustering analysis result. First, deeply analyze the clustering result, view the distribution of data points in each cluster in feature dimensions such as age and disease type, and find the central tendency and similar value ranges. For example, it is found that a certain cluster mostly consists of patients over 60 years old, suffering from cardiovascular diseases, and undergoing coronary artery bypass surgery. Then, for each cluster, extract key features from the patient's individualized and clinical scenario information, such as disease type and surgical name. Then divide the data clusters according to the extracted features and assign descriptive names, such as "cluster of middle-aged patients with minimally invasive lung disease surgery". After division, verify using indicators such as the within-cluster similarity and between-cluster difference calculated by the Euclidean distance. If the similarity of a certain cluster is low or the difference is not obvious, re-examine and adjust. The entire process is closely combined with the technical characteristics of 4D_ICE, and data clusters that better reflect the demand differences of different patients for ultrasonic imaging catheters based on this technology are divided according to the patient's organ structure, disease type, and the advantages and applicable scenarios of 4D_ICE technology, providing accurate basis for subsequent product design, etc.

[0018] Step S140: Use the multiple patient feature data clusters as input variables and the corresponding three-dimensional ultrasound imaging catheter application data as output variables to perform adaptive demand modeling and establish the patient ultrasound imaging catheter demand model. Specifically, to construct an ultrasound imaging catheter that meets the patient's needs, it is crucial to establish a demand model. First, organize the determined patient feature data clusters and three-dimensional ultrasound imaging catheter application data. The former covers information such as patient age, disease, and surgery, and the latter includes feedback such as imaging effect and operation convenience. Encode and quantify them in a unified format to prepare for modeling. Then, select a method according to the data and the modeling goal, such as neural networks and support vector machines. Neural networks are good at dealing with complex non-linear relationships, and support vector machines perform well in small-sample and non-linear problems. If the data volume is large and complex relationships need to be learned, the former can be selected; if the data volume is small and interpretability is valued, the latter can be selected. Taking neural networks as an example, when constructing, determine the number of nodes in the input, hidden, and output layers, train with the organized data, and adjust the weights and biases through algorithms such as stochastic gradient descent to reduce errors. After training, evaluate with a test set and judge by indicators such as mean squared error, mean absolute error, and coefficient of determination. If the results are not satisfactory, optimize from aspects such as adjusting the model structure, training parameters, or further preprocessing the data. The entire process also needs to combine the characteristics of the 4D_ICE technology and optimize the model according to the different demands of different patient clusters for this technology. For example, for patients with complex heart structures, focus on imaging resolution, and for patients who need rapid imaging, pay attention to imaging frame rate. Finally, establish a model that can accurately reflect the patient's needs to assist in catheter research and development.

[0019] Step S200: Based on the patient's ultrasonic imaging catheter requirement model, perform adaptive requirement analysis on the individual characteristic data and clinical application scenario information of the target patient to obtain the patient's ultrasonic imaging catheter requirement parameters. Specifically, to obtain the patient's ultrasonic imaging catheter requirement parameters, it is necessary to perform adaptive requirement analysis on the relevant data of the target patient based on the established requirement model. First, comprehensively collect the individual characteristic data of the target patient, such as age, medical history, disease diagnosis, etc., and the clinical application scenario information, such as the type of surgery, the operating room environment, the patient's body position, etc., and organize and adapt them according to the model requirements, quantifying or encoding the data to conform to the input feature dimensions. Then, input the organized data into the trained model, such as a neural network model. The data is processed layer by layer through the input layer and the hidden layer to mine the data associations, and the special requirements of the ultrasonic imaging catheter are judged by combining the patient's characteristics and the clinical scenario. Next, extract the requirement parameters according to the analysis results, covering key aspects such as imaging performance (resolution, frame rate), catheter physical characteristics (size, flexibility), signal processing capabilities (transmission intensity, anti-interference ability), etc. Finally, calibrate the parameters with reference to the technical characteristics of 4D_ICE. Its two-dimensional probe is paired with an ASIC architecture to achieve high-frame-rate electronic scanning and real-time 3D imaging. For patients undergoing cardiac electrophysiology surgery who require high-frame-rate imaging, optimize the imaging frame rate parameters; according to the patient's need to observe fine structures and combined with the potential for improving the technical resolution, calibrate the resolution parameters to make the requirement parameters more suitable for the application of the ultrasonic imaging catheter based on 4D_ICE technology, providing a strong basis for the subsequent catheter design and manufacturing.

[0020] Step S300: According to the ultrasonic catheter manufacturing requirements, perform multi-module disassembly on the composition structure information of the three-dimensional ultrasonic imaging catheter to obtain N ultrasonic imaging catheter structure modules. Specifically, to meet the ultrasonic catheter manufacturing requirements, multi-module disassembly of the three-dimensional ultrasonic imaging catheter is the key. First, combine the structural characteristics of 4D_ICE technology to comprehensively understand each part of the catheter from the structural schematic diagram, such as the transducer array, capacitor, etc., and at the same time clarify the manufacturing requirements, such as imaging performance and operating performance requirements. Then, determine the disassembly principle based on the relevance between the manufacturing requirements and the component functions, and classify the parts with the same or similar functions into one module according to the functions, and adopt a top-down analysis method for disassembly. During actual disassembly, first separate the catheter body and the cable, and then refine the catheter body. Classify the parts related to the transducer into the ultrasonic transducer module, the connection part into the catheter connector module, the operating part into the handle module, and the protection and guiding part into the sheath module, thus obtaining N modules. Finally, analyze the characteristics of each module, such as the number of array elements and the flexible circuit board wiring of the ultrasonic transducer module, and the material properties and dimensions of the sheath module, etc., and record them in detail to provide basic data for the subsequent module design based on the patient's requirement parameters and lay a solid foundation for the modular design of the manufacturing plan.

[0021] In a possible implementation, the compositional structure information of the three-dimensional ultrasound imaging catheter is disassembled into multiple modules according to the manufacturing requirements of the ultrasound catheter, obtaining N ultrasound imaging catheter structure modules. Step S300 further includes step S310. The N ultrasound imaging catheter structure modules include a sheath module, an ultrasound transducer module, a handle module, and a catheter connector module. Among them, the ultrasound transducer module further includes a transducer array, a flexible circuit board, a chip, and a backing. Specifically, in-depth analysis of the N structural modules of the three-dimensional ultrasound imaging catheter is of great significance for understanding its performance and subsequent manufacturing design. The sheath module plays a role in protecting the internal structure and guiding the catheter into the human body. The material selection should take into account both flexibility and strength, and the size should be determined according to the internal module space and the human physiological structure. For example, the sheath used in cardiac intervention surgery needs to be sized to fit the blood vessels near the heart. In the ultrasound transducer module, the number and arrangement of the elements in the transducer array determine the imaging quality. For example, the nearly a thousand-element linear array arrangement of the 4D_ICE technology greatly improves the imaging effect; the flexible circuit board is responsible for connecting components and transmitting signals, and the wiring should ensure stability and adapt to bending; the chip undertakes signal processing and control tasks, and a high-performance chip can improve the imaging frame rate and clarity; the backing absorbs the after-vibration, reduces interference, and optimizes the imaging contrast. The handle module is designed in accordance with ergonomics, and its shape, size, and grip should fit the doctor's operating habits. It may also integrate control buttons and display devices. The catheter connector module is used to connect the ultrasound transducer module to external devices, and the interface needs to meet industry standards to ensure stable signal transmission, good electrical and mechanical performance. The comprehensive analysis of the modules can provide strong support for the design of the catheter manufacturing scheme based on patient needs.

[0022] Step S400: Based on the patient's ultrasonic imaging catheter requirement parameters, modular design of the manufacturing solutions for the N ultrasonic imaging catheter structure modules is carried out in sequence to obtain the target ultrasonic catheter module manufacturing solution. Specifically, to meet the patient's specific requirements for the ultrasonic imaging catheter, the design of the manufacturing solutions for each structure module needs to be carried out according to the requirement parameters. First, manufacturing data related to the N ultrasonic imaging catheter structure modules are comprehensively collected, including material properties, processing technologies, costs, etc. At the same time, the patient's requirement parameters are deeply analyzed to clarify the specific requirements for each module. Then, the design of each module is carried out. For the sheath module, according to the patient's requirements for the catheter operation flexibility and size, appropriate materials are selected and the size is accurately calculated; for the ultrasonic transducer module, according to requirements such as imaging resolution and frame rate, the number and arrangement of transducer array elements are determined, the flexible circuit board wiring and materials are designed, chips are selected, and the backing is planned; for the handle module, according to the requirements of ergonomics and operation convenience, the shape, size, and holding method are determined, and control buttons and display devices are arranged; for the catheter connector module, according to the requirements of signal transmission stability and compatibility, it is ensured that the interface meets industry standards and the electrical performance is optimized. The manufacturing solutions of each module are integrated into the target ultrasonic catheter module manufacturing solution, and it is evaluated from multiple aspects such as overall performance, cost, and manufacturability. Performance is simulated and analyzed, costs are calculated, and the feasibility of the manufacturing process is evaluated. If there are problems, adjustments are made in a timely manner until the optimal solution is obtained, so as to manufacture an ultrasonic imaging catheter with excellent performance that meets the patient's needs.

[0023] In a possible implementation manner, based on the patient's ultrasonic imaging catheter requirement parameters, modular design of the manufacturing solutions for the N ultrasonic imaging catheter structure modules is performed in sequence to obtain a target ultrasonic catheter module manufacturing solution. Step S400 further includes step S410 of performing manufacturing data crawling based on the N ultrasonic imaging catheter structure modules to obtain N catheter structure module manufacturing data spaces. Specifically, in constructing an ultrasonic catheter manufacturing solution, data crawling and sorting are key basic steps. To obtain comprehensive and accurate manufacturing data, we need to widely search various data sources, such as academic databases like IEEE_Xplore, professional websites such as medical device manufacturing industry information platforms, patent databases, and the official websites of material suppliers. For different data sources, corresponding crawling strategies are formulated. For example, for databases with more structured data, professional crawler tools are used and screening conditions are set; for websites, web crawling technology is used to capture key information according to the web structure; for patent databases, specialized retrieval tools are used to obtain technical solutions. When crawling, rules should be followed to avoid illegal acquisition. Then, according to the strategy, data crawling is performed for each ultrasonic imaging catheter structure module. For example, data such as the number of array elements and material characteristics are collected for the ultrasonic transducer module, and data such as material physical properties and processing techniques are collected for the sheath module. At the same time, preliminary sorting is carried out to remove invalid data and record it in a unified format. Finally, a database management system such as MySQL or MongoDB is used to store the data of each module in different tables respectively, constructing N catheter structure module manufacturing data spaces, and with the help of the database functions, data can be quickly retrieved, analyzed, and updated, providing strong support for subsequent manufacturing solution matching analysis.

[0024] Step S420: Take the patient's ultrasonic imaging catheter requirement parameters as constraint parameters, and perform manufacturing solution matching analysis in the manufacturing data spaces of the N catheter structure modules respectively to obtain a set of N catheter structure module matching solutions. Specifically, after obtaining the manufacturing data spaces of the N catheter structure modules, the patient's ultrasonic imaging catheter requirement parameters should be used as the screening basis to find the matching solutions. First, deeply analyze the requirement parameters, refine the requirements in aspects such as imaging performance, catheter physical characteristics, and signal processing capabilities into specific measurable indicators, such as specifying the pixel value of the resolution, the number of frames per second of the frame rate, the catheter length and diameter range, etc. Then, use the analyzed parameters as the retrieval conditions to retrieve in each data space. For example, in the data space of the ultrasonic transducer module, find the data that matches the number of array elements, arrangement method, and chip processing capabilities according to the imaging requirements; in the data space of the sheath module, retrieve the material, process, and product specification data according to the catheter size and flexibility requirements. Then, perform solution matching on the retrieved data, compare each parameter with the requirement parameters one by one, strictly match the key parameters, and also include the non-key parameters within a reasonable deviation range, so as to screen out the solutions that meet the requirements and form a set of matching solutions. Finally, verify the initially screened solutions through simulation or by referring to similar cases to ensure feasibility and effectiveness, and then organize and record the verified solutions in a unified format, including information such as materials, processes, costs, and performance, providing a reliable basis for subsequent evaluation and optimization.

[0025] Step S430: Based on the N ultrasonic imaging catheter structure modules, establish N ultrasonic imaging catheter module quality evaluation systems. Specifically, establishing N ultrasonic imaging catheter module quality evaluation systems is of great significance for measuring the module quality and subsequent solution optimization. First, clarify the evaluation objectives and scopes for each module. For example, the ultrasonic transducer module focuses on imaging performance, and the evaluation scope covers from material characteristics to imaging effect testing; the sheath module emphasizes physical properties and biocompatibility, and the scope includes all links from raw materials to finished products. Then, determine the evaluation indicators according to the functional characteristics. The ultrasonic transducer module pays attention to imaging resolution, frame rate stability, etc., the sheath module values flexibility, strength, etc., and the handle module analyzes grip comfort, operation convenience, etc. Subsequently, use the analytic hierarchy process and the expert scoring method to set the indicator weights, combined with clinical requirements and usage scenarios. For example, if high-resolution imaging is urgently needed clinically, increase the weight of the imaging resolution of the ultrasonic transducer module. Then, formulate quantitative evaluation criteria for each indicator, divide the imaging resolution levels according to the pixel value range, and set the flexibility levels according to the bending parameters. Finally, integrate the indicators, weights, and standards, and use the weighted average method to establish an evaluation model. Calculate the comprehensive quality score by multiplying the scores of each indicator by the weights and accumulating them, intuitively compare the advantages and disadvantages of the solutions, and lay a solid foundation for subsequent evaluation and optimization of the combination.

[0026] Step S440: Based on the quality evaluation system for the N ultrasonic imaging catheter module sets, evaluate and preferentially combine the N catheter structure module matching scheme sets to obtain a target ultrasonic catheter module manufacturing scheme. Specifically, to finalize the target manufacturing scheme from the matching scheme sets, multiple aspects need to be comprehensively considered. First, according to the quality evaluation system for the N ultrasonic imaging catheter modules, score each scheme in the N catheter structure module matching scheme sets. For example, for the matching scheme of the ultrasonic transducer module, quantify and score it according to indicators such as imaging resolution and frame rate stability against the standards. The same applies to other module schemes to obtain preliminary quality scores. Then, conduct a comprehensive evaluation and analysis. Since the various modules of the ultrasonic catheter are interrelated, in addition to the scores of individual modules, the compatibility and synergy between modules also need to be considered. Use a comprehensive evaluation model to comprehensively evaluate each complete scheme to obtain a comprehensive evaluation result. Then, rank the schemes preferentially according to the results. Preferentially select the scheme with a high comprehensive score, balanced module quality, and good compatibility. Set a screening threshold, compare the key indicators for schemes with similar scores, and combine cost factors to select the one with similar performance but lower cost. Finally, determine the target manufacturing scheme from the top-ranked schemes, taking into account the practical production feasibility, such as material supply and processing technology, to ensure that the scheme achieves the optimal balance of quality, cost, and production feasibility while meeting the needs of patients, providing reliable guidance for ultrasonic catheter manufacturing.

[0027] In a possible implementation, based on the quality evaluation system for the N ultrasonic imaging catheter module sets, evaluate and preferentially combine the N catheter structure module matching scheme sets to obtain a target ultrasonic catheter module manufacturing scheme. Step S440 further includes step S441: Based on the quality evaluation system for the N ultrasonic imaging catheter module sets, conduct a quality evaluation on the N catheter structure module matching scheme sets to obtain a set of quality coefficients for the N catheter structure module schemes. Specifically, to accurately measure the quality of each matching scheme and provide a quantitative basis for subsequent screening, it needs to be carried out in four steps. First, review the quality evaluation system for the N ultrasonic imaging catheter modules, and use the analytic hierarchy process or the expert scoring method to determine the weights of the key evaluation indicators for each module according to clinical needs and technical priorities. For example, if high-resolution imaging is urgently needed clinically, set the weight of the imaging resolution of the ultrasonic transducer module to 0.4. Then, formulate a detailed scoring standard for each evaluation indicator, and divide the imaging resolution of the ultrasonic transducer module into grades and corresponding scores according to the pixel number per square millimeter range. Then, according to the scoring standard, for each scheme in the N catheter structure module matching scheme sets, judge the scoring interval of each indicator and score it, and then calculate the weighted score according to the weight. Finally, summarize the weighted scores of each scheme in each module to obtain the comprehensive score, and organize the comprehensive scores of all schemes into a set of quality coefficients for the N catheter structure module schemes, providing quantitative data support for subsequent manufacturing decisions and scheme optimization.

[0028] Step S442, respectively conduct manufacturing decision impact assessment on the N ultrasonic imaging catheter structure modules to obtain N catheter structure module decision impact factors. Specifically, the manufacturing decision impact assessment is of great significance for determining the influence of each module, guiding resource allocation and program formulation, and can be divided into four steps. The first step is to comprehensively sort out the influencing factors, covering the technical complexity and performance improvement potential at the technical level, such as the ultrasonic transducer module adopts complex technology and new materials to improve performance; the raw materials and manufacturing costs at the cost level, such as special materials leading to increased costs; the urgency and demand at the market demand level, if a functional catheter is urgently needed in the clinic, it will affect the manufacturing decision. The second step is to collect data extensively, understand clinical needs and trends through market research, consult industry reports to grasp technological development, communicate with suppliers to obtain material information, and consult manufacturing companies for processing technology data. The third step is to score the evaluation factors of each module based on the collected data, using a 1-5 point system, such as the ultrasonic transducer module is scored separately due to factors such as technical complexity and great performance improvement potential. Then comprehensively analyze the scores of each factor, and analyze the relative importance to determine the comprehensive impact. In the fourth step, the weighted average method is used to assign weights to each factor according to its importance, and the scores are multiplied by the weights and then added together to determine the decision-making influencing factors of each module. Then, the decision-making influencing factors of N duct structure modules are obtained, which provides strong support for formulating manufacturing decision priority strategies.

[0029] Step S443, determine the catheter module manufacturing decision priority strategy based on the N catheter structure module decision influencing factors. Specifically, determining the catheter module manufacturing decision priority strategy can effectively and reasonably allocate resources and promote manufacturing efficiency and product quality improvement. The specific steps are as follows. First, summarize and organize the N catheter structure module decision influencing factors, present them in the form of tables or charts, analyze the values ​​of each factor and their representative meanings. For example, the ultrasonic transducer module decision influencing factor is high, which means it is critical to the manufacturing decision, thereby preliminarily clarifying the importance ranking of each module. Next, divide the priority level according to the numerical range of the decision influencing factor. For example, the three-equal division method is used to set the first 1 / 3 as high priority, the middle 1 / 3 as medium priority, and the last 1 / 3 as low priority. The high priority module is related to the core function of the ultrasonic catheter, the medium priority has the second highest impact, and the low priority is relatively weak. Then, strategies are formulated for modules of different levels. High-priority modules are allocated human, material and financial resources first, such as arranging senior engineers and equipping advanced equipment for ultrasonic transducer modules; medium-priority modules are allocated reasonably after meeting the resource requirements of high-priority modules; low-priority modules are arranged according to the remaining resources after high- and medium-priority tasks are basically completed. When resources are tight, the process can be simplified or alternative solutions can be found. Finally, the strategy is dynamically adjusted according to the actual situation during the manufacturing process. For example, when high-priority modules encounter technical difficulties and medium-priority modules have technical breakthroughs, the priority is re-evaluated and adjusted. At the same time, attention is paid to market demand, raw material supply, technological development and other factors to ensure that the strategy fits the changing manufacturing environment.

[0030] Step S444, based on the catheter module manufacturing decision priority strategy and the N catheter structure module solution quality coefficient sets, optimize and combine the N catheter structure module matching solution sets to determine the target ultrasonic catheter module manufacturing solution. Specifically, to determine the target ultrasonic catheter module manufacturing solution, it is necessary to comprehensively consider the catheter module manufacturing decision priority strategy and the N catheter structure module solution quality coefficient sets, and comprehensively evaluate each matching solution. First, classify the N catheter structure module matching solution sets according to the priority strategy. Focus on the high-priority modules first, such as the ultrasonic transducer module, and screen high-quality solutions based on key performance indicators and quality coefficients. Then, screen the medium- and low-priority module solutions in turn. Next, according to the quality coefficient sets, calculate the comprehensive quality coefficients of each solution by assigning different weights to different priority modules. The high-priority modules have a high weight, the medium-priority modules have a lower weight, and the low-priority modules have a lower weight, so as to quantify the quality level of the solutions. On the basis of quality evaluation, consider the cost of the solutions, calculate the costs of raw materials, processing, research and development, etc., and give priority to choosing solutions with similar quality but lower costs; at the same time, evaluate the manufacturing feasibility, covering technical maturity, equipment and raw material supply, etc. Finally, comprehensively consider the evaluation results in all aspects, make a comprehensive trade-off and comparison, and select a solution with a high comprehensive quality coefficient, reasonable cost and feasible manufacturing. If the solutions have their own advantages and disadvantages, organize an expert team to conduct multi-dimensional analysis from the aspects of technology, economy and market, and finally determine the target solution that meets the requirements, providing reliable guidance for ultrasonic catheter manufacturing.

[0031] In a possible implementation, based on the catheter module manufacturing decision priority strategy and the set of quality coefficients of the N catheter structure module solutions, the N catheter structure module matching solution sets are preferably combined to determine the target ultrasonic catheter module manufacturing solution. Step S444 further includes step S4441 of obtaining the optimization target of ultrasonic catheter manufacturing and constructing a fitness function for ultrasonic catheter manufacturing according to the optimization target of ultrasonic catheter manufacturing. Specifically, the key to constructing a fitness function for ultrasonic catheter manufacturing lies in accurately grasping the optimization direction and transforming it into a mathematical model. First, by communicating with doctors and medical experts, understand the clinical requirements for imaging effects, conduct market research to clarify consumers' expectations for price, innovation, and functional diversity, and pay attention to the industry to understand the progress of new materials and processes. Comprehensively determine optimization targets such as improving imaging quality, reducing costs, shortening the cycle, and increasing material utilization rate. Then, identify the relevant influencing factors around the target. For example, imaging quality is affected by the performance of ultrasonic transducers, costs involve raw materials, processing, and labor, the cycle is affected by processes, equipment, and the supply chain, and material utilization rate is related to product design and process losses. Then, quantify the above factors. Imaging quality is measured by resolution, frame rate, and noise ratio, cost is in currency units, the cycle is in time, and material utilization rate is in percentage. For factors that are difficult to quantify, set corresponding numerical values for levels. Finally, according to the optimization target and the quantified factors, use mathematical models such as weighted summation to construct a fitness function. Determine the weights of each factor through expert scoring and the analytic hierarchy process, and adjust the weight distribution according to the focus, providing a powerful tool for subsequent solution evaluation and optimization.

[0032] Step S4442, according to the catheter module manufacturing decision priority strategy and the set of quality coefficients of the N catheter structure module solutions, determine the first set of quality coefficients of the first catheter structure module. Specifically, screening out the relevant quality coefficients of the first catheter structure module from numerous data can provide a key basis for subsequent determination of the manufacturing solution. First, based on the catheter module manufacturing decision priority strategy, comprehensively consider factors such as technical complexity, performance improvement potential, cost, and market demand, calculate the decision influence factor, and find the one with the largest factor from the N ultrasonic imaging catheter structure modules, which is determined as the first catheter structure module. For example, the ultrasonic transducer module that has a great impact on imaging quality is likely to be selected. Then, in the set of quality coefficients of the N catheter structure module solutions, extract the solution quality coefficients related to this module, and these coefficients reflect the quality level of this module under different solutions. Finally, organize and summarize the extracted coefficients, and arrange them according to rules such as from high to low to form the first set of quality coefficients of the first catheter structure module, which is convenient for subsequent screening of the most suitable manufacturing solution in combination with other factors.

[0033] Step S4443: Based on the first set of scheme quality coefficients, optimize the set of N catheter structure module matching schemes to determine the first catheter module manufacturing scheme. Specifically, to find the manufacturing scheme suitable for the first catheter module from numerous schemes, the following steps can be taken. First, based on the first set of scheme quality coefficients, preliminarily screen the schemes related to the first catheter structure module in the set of N catheter structure module matching schemes, focusing on those with high quality coefficients. For example, in the matching schemes of the ultrasonic transducer module, preferentially select the top 30% of the schemes to enter the next round. Then, conduct a technical feasibility assessment on the preliminarily screened schemes, analyzing whether the technologies involved in the schemes are mature, and whether there is sufficient technical support and professional talents. For example, when adopting new technologies, consider whether there are high-precision processing equipment and professional personnel. Then, conduct a cost-benefit analysis, calculate the costs such as raw material procurement and processing manufacturing, estimate the benefits after implementation, and select the scheme with low cost and high benefits after comparison. Finally, comprehensively consider the results of quality coefficients, technical feasibility, and cost-benefit analysis, and make an overall trade-off and comparison to determine the first catheter module manufacturing scheme that not only ensures quality but also has technical feasibility and good cost-benefit, laying a solid foundation for the subsequent ultrasonic catheter manufacturing.

[0034] Step S4444: Using the ultrasonic catheter manufacturing fitness function, based on the first catheter module manufacturing scheme and the set of N catheter structure module scheme quality coefficients, perform a Nash equilibrium optimization combination on the set of N catheter structure module matching schemes to determine the target ultrasonic catheter module manufacturing scheme. Specifically, to determine the target ultrasonic catheter module manufacturing scheme, it is necessary to optimize the combination of schemes by means of the fitness function and the Nash equilibrium algorithm. First, based on the first catheter module manufacturing scheme with the largest decision influence factor and the best quality, combine it with the other module schemes in the set of N catheter structure module matching schemes to construct an initial overall scheme combination. For example, combine the determined ultrasonic transducer module manufacturing scheme with the schemes of the sheath tube, handle module, etc. Then, substitute each initial scheme combination into the ultrasonic catheter manufacturing fitness function that comprehensively considers factors such as the set of catheter structure module scheme quality coefficients, cost, production efficiency, and material utilization rate, and calculate the fitness value through weighted calculation to evaluate the pros and cons of the scheme. Subsequently, perform Nash equilibrium optimization iteration, keep the first catheter module manufacturing scheme unchanged, select other schemes from the matching scheme set to recombine with it, calculate and compare the fitness values of the new schemes. If the fitness value is higher, the optimization is successful. Continuously repeat this process to strive for the maximum fitness of the remaining sequence module scheme combinations. After multiple rounds of iteration, when no scheme combination with a higher fitness value can be found, this scheme is the target scheme, which not only ensures the best quality of the first catheter structure module manufacturing scheme but also realizes the comprehensive optimization of the fitness of the remaining module scheme combinations in multiple aspects.

[0035] Step S500: Conduct catheter manufacturing simulation on the target ultrasonic catheter module manufacturing solution to obtain catheter manufacturing simulation parameters, and based on the catheter manufacturing simulation parameters, perform design optimization and flexible manufacturing decision-making on the target ultrasonic catheter module manufacturing solution. Specifically, conducting catheter manufacturing simulation on the target ultrasonic catheter module manufacturing solution and carrying out design optimization and flexible manufacturing decision-making based on the simulation parameters can improve the manufacturing quality and efficiency of ultrasonic catheters. First, conduct catheter manufacturing simulation. Based on the structural characteristics of the 4D_ICE ultrasonic catheter, construct a simulation model in combination with the solution, and accurately build it with reference to the structural schematic diagram; determine simulation parameters such as the number of matrix elements and catheter diameter according to relevant literature, and select a suitable algorithm; set boundary conditions for simulating the real working environment, start the simulation, and record catheter manufacturing simulation parameters such as material forming accuracy and stress distribution. Then, perform design optimization based on the simulation parameters, compare the differences between the parameters and the design objectives, and pay attention to unique performance requirements such as the 4D_ICE real-time generation of 3D images; propose optimization solutions for problems, such as adjusting the array element arrangement and changing the catheter material; evaluate the feasibility of the solutions, comprehensively analyze factors such as manufacturing processes and costs. Finally, make flexible manufacturing decisions, analyze the impact of the simulation parameters on each manufacturing link, considering the particularity of 4D_ICE manufacturing; formulate flexible manufacturing strategies, flexibly adjust processes and equipment, and reasonably arrange production plans; implement the manufacturing process and monitor it in real time, compare the actual and simulation parameters, calibrate the deviations in a timely manner, and continuously improve the strategies to improve manufacturing quality and efficiency.

[0036] In a possible implementation, a catheter manufacturing simulation is performed on the manufacturing solution of the target ultrasonic catheter module to obtain catheter manufacturing simulation parameters. Based on the catheter manufacturing simulation parameters, design optimization and flexible manufacturing decision-making are carried out on the manufacturing solution of the target ultrasonic catheter module. Step S500 further includes step S510, which is to perform optimization analysis on the manufacturing solution of the target ultrasonic catheter module based on the catheter manufacturing simulation parameters to obtain an optimization selection threshold for the catheter manufacturing solution. Specifically, performing optimization analysis on the manufacturing solution of the target ultrasonic catheter module based on the catheter manufacturing simulation parameters to obtain an optimization selection threshold for the catheter manufacturing solution is extremely crucial for improving the quality of the manufacturing solution. First, comprehensively sort out the simulation parameters. According to the characteristics of the 4D_ICE ultrasonic catheter, they are divided into categories such as signal transmission, structural mechanics, and material properties, such as parameters like signal attenuation rate, catheter wall stress distribution, and material acoustic properties. Then, refer to industry standards and successful cases to set target reference values, adjust them in combination with factors such as cost and technical feasibility, and set the signal attenuation rate to be less than 5% according to the imaging requirements. Then, compare the simulation parameters with the target reference values, calculate the deviation degree, and analyze the reasons for the parameters with large deviations. For example, if the signal transmission delay is long or the stress value exceeds the standard. If the signal attenuation rate is high, it may be a problem with the material or shielding design. Finally, considering factors such as the adjustment range of the manufacturing process, cost, and technical difficulty, optimize selection thresholds are set for different categories of parameters respectively. For example, when the signal attenuation rate deviation is between 2% - 3%, optimize the process; if it exceeds the range, redesign or change the material, which is used as the basis for scheme optimization.

[0037] Step S520: Optimally select thresholds according to the catheter manufacturing plan and initialize the particle swarm space. Specifically, initializing the particle swarm space is the key start for the particle swarm optimization algorithm to find the optimal ultrasound catheter manufacturing plan, which should be carried out based on optimally selecting thresholds according to the catheter manufacturing plan. First, determine the particle dimensions and coding based on the key factors of the ultrasound catheter manufacturing plan. These factors cover catheter structure design, such as catheter diameter, length, and layout of each part, acoustic, electrical, and mechanical strength characteristics in material selection, and manufacturing process parameters such as processing temperature, pressure, and time. Binary or real number coding is used to encode the parameter values of the manufacturing plan represented by each particle dimension. For example, the catheter diameter of 8F - 12F is encoded as a real number between 0 and 1 and then mapped and converted. Then, set the initial positions of the particles according to the optimally selected thresholds, randomly generated within the feasible value ranges of each parameter according to rules. For example, the signal attenuation rate is randomly selected within the threshold range of 3% - 7%. Subsequently, determine the initial velocities of the particles, setting the value ranges according to the influence degree of the parameters on the manufacturing plan, usually set as random values between -1 and 1. The velocity range of sensitive parameters is small to ensure accuracy, and the velocity range of parameters with little influence can be relaxed. Finally, initialize other parameters of the particle swarm, determine the particle swarm size of about 50 - 100 according to the complexity of the problem, set the learning factor between 1.5 and 2.5 to control the learning degree towards its own and the group's historical optimal positions, and then set the maximum number of iterations of about 100 - 500 according to computing resources and convergence speed.

[0038] Step S530: Use the ultrasound catheter manufacturing fitness function to perform iterative optimization within the particle swarm space until a preset termination condition is reached, obtain the optimized manufacturing plan for the ultrasound catheter module, and make a flexible manufacturing decision for the catheter based on the optimized manufacturing plan for the ultrasound catheter module. Specifically, this process mainly optimizes the ultrasound catheter manufacturing plan through the particle swarm algorithm to obtain the optimal plan and make a flexible manufacturing decision. In the initialized particle swarm space, substitute the manufacturing plan represented by each particle into the ultrasound catheter manufacturing fitness function. This function comprehensively considers key indicators such as imaging quality, cost, and production efficiency, calculates the initial fitness value, and reflects the comprehensive performance of the plan. Subsequently, compare the initial fitness values of each particle with the historical optimal values, update the individual optimal positions and fitness values; find the best among all particles and update the global optimal position and fitness value. Then, according to the particle swarm algorithm update formula, refer to the individual and global optimal positions to update the particle velocities and positions, and continuously iterate through the formulas and where, is the velocity of particle at time, which determines its moving direction and step size; is the inertia weight, which balances global and local searches. A large value is beneficial for global search, and a small value focuses on local search. It usually decreases with iteration; is particle at The velocity at a moment reflects the historical trend of motion; and is the learning factor, which controls the particle to move towards its own historical optimal position the degree of learning, which controls the degree of learning towards the historical optimal position of the group The degree of learning ranges from 1.5 to 2.5; and is a random number between 0 and 1, which increases the search randomness to prevent premature convergence; is the particle at the individual optimal position at a moment, which is its own experience; is the particle at the position at a moment; is the global optimal position of the particle swarm at a moment, which reflects the group experience. The particle continuously iterates towards the global optimal solution through this to obtain the optimized manufacturing plan for the ultrasonic catheter module. After each iteration, the preset termination conditions are checked, such as reaching the maximum number of iterations (set to 200 times) or the fitness value converges (the change is less than 0.001). When the conditions are met, the plan corresponding to the global optimal position is the optimized manufacturing plan for the ultrasonic catheter module, and this plan achieves balanced optimization in multiple indicators. Finally, based on this optimized plan, flexible manufacturing decisions are made. Considering the application scenario differences of 4D_ICE ultrasonic catheters and production fluctuation factors, such as raw material performance fluctuations and order quantity changes, the processing process parameters are adjusted, and the equipment and personnel are reasonably arranged to achieve efficient and flexible production to meet the diverse market demands.

[0039] In the embodiments of the present application, a demand model for a patient's ultrasonic imaging catheter is established, and individual characteristic data and clinical application scenario information of the target patient are collected; through this demand model, adaptive demand analysis is carried out to obtain the demand parameters of the patient's ultrasonic imaging catheter; according to the manufacturing requirements of the ultrasonic catheter, the three-dimensional ultrasonic imaging catheter is disassembled into multiple modules to obtain multiple catheter structure modules; based on the patient's demand parameters, modular design of the manufacturing plan for these structure modules is carried out, and finally the manufacturing plan for the target catheter module is obtained; catheter manufacturing simulation is carried out to obtain relevant simulation parameters, and the manufacturing plan is optimized according to these parameters to complete the flexible manufacturing decision. By establishing a demand model for a patient's ultrasonic imaging catheter and combining the individual characteristic data and clinical application scenario information of the patient, the technical effect of accurately designing and customizing the three-dimensional ultrasonic imaging catheter is achieved.

[0040] In the above text, with reference to Figure 1 a flexible manufacturing decision method for a three-dimensional ultrasonic imaging catheter according to an embodiment of the present invention is described in detail. Next, with reference to Figure 2Describe a flexible manufacturing decision-making system for a three-dimensional ultrasonic imaging catheter according to an embodiment of the present invention.

[0041] The flexible manufacturing decision-making system for a three-dimensional ultrasonic imaging catheter according to an embodiment of the present invention is used to solve the technical problem in the prior art that a customized three-dimensional ultrasonic imaging catheter cannot be accurately designed and manufactured according to the personalized needs of patients and clinical scenarios. By establishing a patient ultrasonic imaging catheter requirement model and combining the individual characteristic data of the patient and the clinical application scenario information, the technical effect of accurately designing and customizing the manufacturing of a three-dimensional ultrasonic imaging catheter is achieved. The flexible manufacturing decision-making system for a three-dimensional ultrasonic imaging catheter includes: a requirement model construction module 10, an adaptive requirement analysis module 20, a multi-module disassembly module 30, a manufacturing plan acquisition module 40, and a catheter manufacturing simulation parameter acquisition module 50.

[0042] The requirement model construction module 10 is used to establish a patient ultrasonic imaging catheter requirement model and simultaneously collect and obtain the individual characteristic data of the target patient and the clinical application scenario information.

[0043] The adaptive requirement analysis module 20 is used to perform adaptive requirement analysis on the individual characteristic data of the target patient and the clinical application scenario information based on the patient ultrasonic imaging catheter requirement model to obtain patient ultrasonic imaging catheter requirement parameters.

[0044] The multi-module disassembly module 30 is used to perform multi-module disassembly on the composition structure information of the three-dimensional ultrasonic imaging catheter according to the ultrasonic catheter manufacturing requirements to obtain N ultrasonic imaging catheter structure modules.

[0045] The manufacturing plan acquisition module 40 is used to perform modular design of the manufacturing plans for the N ultrasonic imaging catheter structure modules in sequence based on the patient ultrasonic imaging catheter requirement parameters to obtain a target ultrasonic catheter module manufacturing plan.

[0046] The catheter manufacturing simulation parameter acquisition module 50 is used to perform catheter manufacturing simulation on the target ultrasonic catheter module manufacturing plan to obtain catheter manufacturing simulation parameters, and perform design optimization and flexible manufacturing decision-making on the target ultrasonic catheter module manufacturing plan based on the catheter manufacturing simulation parameters.

[0047] Next, the specific configuration of the requirements model construction module 10 will be described in detail. As described above, a requirements model for a patient's ultrasonic imaging catheter is established, and at the same time, the individual characteristic data and clinical application scenario information of the target patient are collected. The requirements model construction module 10 further includes: a regional patient dataset collection unit, which is used to collect and obtain a regional patient dataset, and the regional patient dataset includes patient individual characteristic data, clinical application scenario information, and corresponding three-dimensional ultrasonic imaging catheter application data; a clustering analysis unit, which is used to perform clustering analysis on the patient individual characteristic data and clinical application scenario information to obtain a clustering result of patient characteristic data; a patient characteristic data cluster determination unit, which is used to determine multiple patient characteristic data clusters according to the clustering result of patient characteristic data; an adaptive requirements modeling unit, which is used to use the multiple patient characteristic data clusters as input variables and the corresponding three-dimensional ultrasonic imaging catheter application data as output variables for adaptive requirements modeling to establish the requirements model for the patient's ultrasonic imaging catheter.

[0048] Next, the specific configuration of the multi-module disassembly module 30 will be described in detail. As described above, the component structure information of the three-dimensional ultrasonic imaging catheter is disassembled into multiple modules according to the ultrasonic catheter manufacturing requirements to obtain N ultrasonic imaging catheter structure modules. The multi-module disassembly module 30 further includes: an ultrasonic imaging catheter structure module composition unit, and the N ultrasonic imaging catheter structure modules include a sheath tube module, an ultrasonic transducer module, a handle module, and a catheter connector module. Among them, the ultrasonic transducer module further includes a transducer array, a flexible circuit board, a chip, and a backing.

[0049] Next, the specific configuration of the manufacturing solution acquisition module 40 will be described in detail. As described above, based on the patient's ultrasonic imaging catheter requirement parameters, modular design of manufacturing solutions is performed on the N ultrasonic imaging catheter structure modules in sequence to obtain the manufacturing solution for the target ultrasonic catheter module. The manufacturing solution acquisition module 40 further includes: a manufacturing data crawling unit, which is used to crawl manufacturing data based on the N ultrasonic imaging catheter structure modules to obtain an N - catheter - structure - module manufacturing data space; a solution matching and analysis unit, which is used to use the patient's ultrasonic imaging catheter requirement parameters as constraint parameters and perform manufacturing solution matching and analysis in the N - catheter - structure - module manufacturing data spaces respectively to obtain an N - catheter - structure - module matching solution set; a quality evaluation system construction unit, which is used to establish an N - ultrasonic - imaging - catheter - module quality evaluation system according to the N ultrasonic imaging catheter structure modules; and an evaluation and optimization combination unit, which is used to perform evaluation, optimization, and combination on the N - catheter - structure - module matching solution set based on the N - ultrasonic - imaging - catheter - module quality evaluation system to obtain the manufacturing solution for the target ultrasonic catheter module.

[0050] Among them, when performing evaluation, optimization, and combination on the N - catheter - structure - module matching solution set based on the N - ultrasonic - imaging - catheter - module quality evaluation system to obtain the manufacturing solution for the target ultrasonic catheter module, the evaluation and optimization combination unit further includes: a quality evaluation subunit, which is used to perform quality evaluation on the N - catheter - structure - module matching solution set based on the N - ultrasonic - imaging - catheter - module quality evaluation system to obtain an N - catheter - structure - module solution quality coefficient set; a manufacturing decision - impact evaluation subunit, which is used to perform manufacturing decision - impact evaluation on the N ultrasonic imaging catheter structure modules respectively to obtain N catheter - structure - module decision - impact factors; a priority strategy determination subunit, which is used to determine the manufacturing decision priority strategy for the catheter module according to the N catheter - structure - module decision - impact factors; and a target ultrasonic catheter module manufacturing solution determination subunit, which is used to perform optimization and combination on the N - catheter - structure - module matching solution set based on the catheter - module manufacturing decision priority strategy and the N - catheter - structure - module solution quality coefficient set to determine the manufacturing solution for the target ultrasonic catheter module.

[0051] Among them, based on the catheter module manufacturing decision priority strategy and the N catheter structure module scheme quality coefficient sets, the N catheter structure module matching scheme sets are preferentially combined to determine the target ultrasonic catheter module manufacturing scheme. The target ultrasonic catheter module manufacturing scheme determination subunit further includes: a fitness function construction micro-unit, which is used to obtain the ultrasonic catheter manufacturing optimization target and construct an ultrasonic catheter manufacturing fitness function according to the ultrasonic catheter manufacturing optimization target; a first scheme quality coefficient set determination micro-unit, which is used to determine the first scheme quality coefficient set of the first catheter structure module according to the catheter module manufacturing decision priority strategy and the N catheter structure module scheme quality coefficient sets; a first catheter module manufacturing scheme determination micro-unit, which is used to preferentially select the N catheter structure module matching scheme sets based on the first scheme quality coefficient set to determine the first catheter module manufacturing scheme; a Nash equilibrium optimization combination micro-unit, which is used to perform Nash equilibrium optimization combination on the N catheter structure module matching scheme sets based on the ultrasonic catheter manufacturing fitness function, the first catheter module manufacturing scheme and the N catheter structure module scheme quality coefficient sets to determine the target ultrasonic catheter module manufacturing scheme.

[0052] Next, the specific configuration of the catheter manufacturing simulation parameter acquisition module 50 will be described in detail. As described above, the catheter manufacturing simulation is performed on the target ultrasonic catheter module manufacturing scheme to obtain catheter manufacturing simulation parameters, and based on the catheter manufacturing simulation parameters, design optimization and flexible manufacturing decision-making are performed on the target ultrasonic catheter module manufacturing scheme. The catheter manufacturing simulation parameter acquisition module 50 further includes: an optimization selection threshold acquisition unit, which is used to perform optimization analysis on the target ultrasonic catheter module manufacturing scheme based on the catheter manufacturing simulation parameters to obtain the catheter manufacturing scheme optimization selection threshold; an initialization particle swarm space unit, which is used to initialize the particle swarm space according to the catheter manufacturing scheme optimization selection threshold; an iterative optimization unit, which is used to perform iterative optimization in the particle swarm space by using the ultrasonic catheter manufacturing fitness function until a preset termination condition is reached to obtain an optimized manufacturing scheme for the ultrasonic catheter module, and perform catheter flexible manufacturing decision-making based on the optimized manufacturing scheme for the ultrasonic catheter module.

[0053] The flexible manufacturing decision-making system for a three-dimensional ultrasonic imaging catheter provided by the embodiment of the present invention can execute the flexible manufacturing decision-making method for a three-dimensional ultrasonic imaging catheter provided by any embodiment of the present invention, and has the corresponding functional modules and beneficial effects for executing the method.

[0054] Although this application makes various references to certain modules in the system according to the embodiments of this application, however, any number of different modules can be used and run on the user terminal and / or the server. The various units and modules included are only divided according to functional logic, but are not limited to the above division, as long as the corresponding functions can be achieved; in addition, the specific names of the functional units are only for the convenience of mutual distinction and are not used to limit the protection scope of the present invention.

[0055] The above specific implementation manners do not constitute a limitation on the protection scope of this application. Those skilled in the art should understand that various modifications, combinations, and substitutions can be made according to design requirements and other factors. Any modifications, equivalent substitutions, and improvements made within the spirit and principle of this application shall be included within the protection scope of this application.

Claims

1. A flexible manufacturing decision-making method for three-dimensional ultrasound imaging catheters, characterized in that: The method comprises: Establish a patient ultrasound imaging catheter demand model, and collect individualized characteristic data and clinical application scenario information of target patients; Based on the patient ultrasound imaging catheter demand model, an adaptive demand analysis is performed on the individualized characteristic data and clinical application scenario information of the target patient to obtain the patient ultrasound imaging catheter demand parameters; According to the ultrasonic catheter manufacturing requirements, the component structure information of the three-dimensional ultrasonic imaging catheter is disassembled into multiple modules to obtain N ultrasonic imaging catheter structure modules; Based on the patient ultrasound imaging catheter requirement parameters, the N ultrasound imaging catheter structure modules are sequentially modularly designed for manufacturing solutions to obtain a target ultrasound catheter module manufacturing solution; A catheter manufacturing simulation is performed on the target ultrasonic catheter module manufacturing scheme to obtain catheter manufacturing simulation parameters, and design optimization and flexible manufacturing decision are performed on the target ultrasonic catheter module manufacturing scheme based on the catheter manufacturing simulation parameters.

2. The flexible manufacturing decision method for three-dimensional ultrasound imaging catheter according to claim 1, characterized in that: The establishing of the patient ultrasound imaging catheter demand model comprises: Acquiring a regional patient data set, wherein the regional patient data set includes individualized patient feature data, clinical application scenario information, and corresponding three-dimensional ultrasound imaging catheter application data; Performing cluster analysis on the individualized characteristic data of the patients and the clinical application scenario information to obtain clustering results of the patient characteristic data; Determining a plurality of patient characteristic data clusters according to the patient characteristic data clustering result; The plurality of patient characteristic data clusters are used as input variables and the corresponding three-dimensional ultrasound imaging catheter application data are used as output variables to perform adaptive demand modeling, thereby establishing the patient ultrasound imaging catheter demand model.

3. The flexible manufacturing decision method for three-dimensional ultrasound imaging catheter according to claim 1, characterized in that: The method for obtaining a target ultrasonic catheter module manufacturing scheme includes: Crawling manufacturing data based on the N ultrasound imaging catheter structure modules to obtain N catheter structure module manufacturing data spaces; Taking the patient ultrasound imaging catheter requirement parameters as constraint parameters, respectively performing manufacturing scheme matching analysis in the manufacturing data space of the N catheter structure modules to obtain a set of matching schemes for the N catheter structure modules; According to the N ultrasound imaging catheter structure modules, establishing N ultrasound imaging catheter module quality evaluation systems; Based on the N ultrasound imaging catheter module quality evaluation systems, the N catheter structure module matching solution sets are evaluated and optimally combined to obtain a target ultrasound catheter module manufacturing solution.

4. The flexible manufacturing decision method for three-dimensional ultrasound imaging catheter according to claim 3, characterized in that: The method for obtaining a target ultrasonic catheter module manufacturing scheme includes: Based on the N ultrasound imaging catheter module quality evaluation systems, the N catheter structure module matching solution sets are quality evaluated to obtain N catheter structure module solution quality coefficient sets; Performing manufacturing decision impact assessments on the N ultrasound imaging catheter structure modules respectively to obtain N catheter structure module decision impact factors; Determining a catheter module manufacturing decision priority strategy according to the N catheter structure module decision influencing factors; Based on the catheter module manufacturing decision priority strategy and the N catheter structure module solution quality coefficient sets, the N catheter structure module matching solution sets are optimally combined to determine the target ultrasound catheter module manufacturing solution.

5. The flexible manufacturing decision method for three-dimensional ultrasound imaging catheter according to claim 4, characterized in that: The method of determining a target ultrasonic catheter module manufacturing scheme comprises: Acquiring an ultrasonic catheter manufacturing optimization target, and constructing an ultrasonic catheter manufacturing fitness function according to the ultrasonic catheter manufacturing optimization target; Determine a first solution quality coefficient set for a first catheter structure module according to the catheter module manufacturing decision priority strategy and the N catheter structure module solution quality coefficient sets; Optimizing the N catheter structure module matching solution sets based on the first solution quality coefficient set to determine a first catheter module manufacturing solution; The ultrasonic catheter manufacturing fitness function is used to perform Nash equilibrium optimization combination on the N catheter structure module matching solution sets based on the first catheter module manufacturing solution and the N catheter structure module solution quality coefficient sets to determine the target ultrasonic catheter module manufacturing solution.

6. The flexible manufacturing decision method for three-dimensional ultrasound imaging catheter according to claim 5, characterized in that: The design optimization and flexible manufacturing decision making of the target ultrasound catheter module manufacturing scheme based on the catheter manufacturing simulation parameters include: Optimizing and analyzing the target ultrasound catheter module manufacturing scheme based on the catheter manufacturing simulation parameters to obtain a catheter manufacturing scheme optimization selection threshold; Optimizing and selecting a threshold value according to the catheter manufacturing scheme, and initializing the particle swarm space; The ultrasonic catheter manufacturing fitness function is used to iteratively search for the best in the particle swarm space until a preset termination condition is reached, thereby obtaining an optimized manufacturing plan for the ultrasonic catheter module, and making a catheter flexible manufacturing decision based on the optimized manufacturing plan for the ultrasonic catheter module.

7. The flexible manufacturing decision method for three-dimensional ultrasound imaging catheter according to claim 1, characterized in that: The N ultrasound imaging catheter structure modules include a sheath module, an ultrasound transducer module, a handle module and a catheter connector module, wherein the ultrasound transducer module also includes a transducer array, a flexible circuit board, a chip and a backing.

8. A flexible manufacturing decision system for three-dimensional ultrasound imaging catheters, characterized in that: The system is used to implement the flexible manufacturing decision method for a three-dimensional ultrasound imaging catheter according to any one of claims 1 to 7, and the system comprises: A demand model building module, which is used to establish a patient ultrasound imaging catheter demand model and simultaneously collect individualized feature data and clinical application scenario information of target patients; An adaptive demand analysis module, wherein the adaptive demand analysis module is used to perform an adaptive demand analysis on the individualized feature data and clinical application scenario information of the target patient based on the patient ultrasound imaging catheter demand model to obtain patient ultrasound imaging catheter demand parameters; A multi-module disassembly module, wherein the multi-module disassembly module is used to disassemble the component structure information of the three-dimensional ultrasonic imaging catheter into multiple modules according to the ultrasonic catheter manufacturing requirements to obtain N ultrasonic imaging catheter structure modules; A manufacturing solution acquisition module, wherein the manufacturing solution acquisition module is used to sequentially perform a modular design of manufacturing solutions for the N ultrasound imaging catheter structure modules based on the patient ultrasound imaging catheter requirement parameters to obtain a target ultrasound catheter module manufacturing solution; A catheter manufacturing simulation parameter acquisition module is used to perform catheter manufacturing simulation on the target ultrasonic catheter module manufacturing plan to obtain catheter manufacturing simulation parameters, and perform design optimization and flexible manufacturing decision on the target ultrasonic catheter module manufacturing plan based on the catheter manufacturing simulation parameters.

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