中国医疗器械杂志Pub Date : 2024-11-30DOI: 10.12455/j.issn.1671-7104.230715
Tianfeng Leng, Yu Zheng, Shaofeng Han, Chenhan Guang, Yang Yang
{"title":"[Tooth Design of Ophthalmic Microsurgical Forceps Based on Minimum Slip Force].","authors":"Tianfeng Leng, Yu Zheng, Shaofeng Han, Chenhan Guang, Yang Yang","doi":"10.12455/j.issn.1671-7104.230715","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230715","url":null,"abstract":"<p><p>This study proposed the use of the minimum slip force as an indicator to measure the clamping ability of microsurgical forceps. By analyzing the minimum slip forces of four typical tooth types of microsurgical forceps, the clamping capacity of each type was evaluated. Among the existing tooth forms, the staggered tooth type exhibited a relatively large minimum slip force. Consequently, a new tooth-shaped structure for microsurgical forceps - the hemispherical convex structure was proposed. Simulation and experimental studies demonstrated that this new dental structure could achieve stable and reliable clamping.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"678-682"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
中国医疗器械杂志Pub Date : 2024-11-30DOI: 10.12455/j.issn.1671-7104.240163
Nan Zhang, Jing Li, Jie Zhang, Jiong Yang, Zhengbo Zhang, Kunlun He
{"title":"[Discussion about Testing Scheme of Intelligent Medical Devices].","authors":"Nan Zhang, Jing Li, Jie Zhang, Jiong Yang, Zhengbo Zhang, Kunlun He","doi":"10.12455/j.issn.1671-7104.240163","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240163","url":null,"abstract":"<p><p>Intelligent medical devices are flourishing with the deep integration of modern information and artificial intelligence technologies into healthcare. Testing is an important means of performance evaluation and quality control for intelligent medical devices. Compared with traditional medical devices, the testing methods and technologies of intelligent medical devices are still immature, and need active research to promote the progress in this area. Intelligent medical devices are classified according to their characteristics as artificial intelligence medical devices in the form of software and medical robots based on a general discussion of their development. The medical-device Internet of Things (IoT) system has also been included due to its close relation to the construction of smart hospitals. For each type of intelligent medical device, testing indexes and testing plans are discussed. It is suggested that specific test rules should be further developed for various specific devices. Besides, the evaluation method of complex intelligent systems should be introduced and real-world data should be used for evaluation. This paper aims to accelerate the development of intelligent medical device testing, laying the foundation for quality control and performance evaluation of intelligent medical devices.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"699-705"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
中国医疗器械杂志Pub Date : 2024-11-30DOI: 10.12455/j.issn.1671-7104.240152
Shuai Zhang, Peng Han, Suya Zhang, Dingli Ye, Zhicheng Huang
{"title":"[Application of CT Radiomics in Predicting Differentiation Level of Lung Adenocarcinoma].","authors":"Shuai Zhang, Peng Han, Suya Zhang, Dingli Ye, Zhicheng Huang","doi":"10.12455/j.issn.1671-7104.240152","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240152","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the value of prediction of the differentiation level in lung adenocarcinoma based on CT radiomics model.</p><p><strong>Methods: </strong>Data from 507 patients with postoperative pathological confirmed lung adenocarcinoma and clearly defined differentiation level of lung adenocarcinoma were retrospective analyzed. The enrolled cases were divided into poorly differentiation group and moderate-to-high differentiation group based on the grading criteria. CT image features were extracted, and seven machine learning algorithms were used to construct prediction models to obtain the AUC, accuracy, specificity, and sensitivity.</p><p><strong>Results: </strong>The poorly differentiation group consisted of 175 cases, while the moderate-to-high differentiation group had 332 cases. The XGBoost model demonstrated the best performance, with the AUC, accuracy, specificity, and sensitivity of this model on the validation set being 0.878, 0.829, 0.667, and 0.727, respectively.</p><p><strong>Conclusion: </strong>CT radiomics model can effectively predict the differentiation level of poorly differentiation and moderate-to-high differentiation in lung adenocarcinoma.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"591-594"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787693","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
中国医疗器械杂志Pub Date : 2024-11-30DOI: 10.12455/j.issn.1671-7104.240143
Sanchao Liu, Nong Yan, Xingliang Jin, Xianliang He, Ke Xiao, Hanyuan Luo, Huacheng Luo, Yongjun Zeng, Jie Qin, Yinbing Yang, Yalan Li, Lan Gao
{"title":"[Comparative Evaluation of Encephalon State Index and Bispectral Index in Monitoring the Depth of Anesthesia during the Surgical Anesthesia Stage].","authors":"Sanchao Liu, Nong Yan, Xingliang Jin, Xianliang He, Ke Xiao, Hanyuan Luo, Huacheng Luo, Yongjun Zeng, Jie Qin, Yinbing Yang, Yalan Li, Lan Gao","doi":"10.12455/j.issn.1671-7104.240143","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240143","url":null,"abstract":"<p><strong>Objective: </strong>Evaluate the performance of the encephalon state index (ESI) in depth of anesthesia monitoring during clinical surgery, compared with the bispectral index (BIS).</p><p><strong>Methods: </strong>ESI and BIS data were collected from 60 patients in a single-center clinical trial to compare their efficacy in measuring the depth of anesthesia.</p><p><strong>Results: </strong>Consistency analysis revealed mean differences and standard deviations of -0.18 ± 5.42 and -0.11 ± 6.51 between ESI and BIS for awake and anesthetized states, respectively. Correlation analysis showed a correlation coefficient of 0.92 throughout the operative period. Prediction probability analysis indicated that both ESI and BIS had prediction probabilities of 0.97, effectively predicting anesthesia status.</p><p><strong>Conclusion: </strong>ESI and BIS show good equivalence in monitoring depth of anesthesia during clinical surgery, which meet the requirements of clinical anesthesia.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"639-644"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
中国医疗器械杂志Pub Date : 2024-11-30DOI: 10.12455/j.issn.1671-7104.230398
Haijun Wei, Hanlin Li, Hui Huang, Kai Wang, Yan Hang, Jilun Ye, Xu Zhang
{"title":"[Development of Multi-Parameter Exercise Cardiopulmonary Function Evaluation System with Impedance Cardiogram Monitoring].","authors":"Haijun Wei, Hanlin Li, Hui Huang, Kai Wang, Yan Hang, Jilun Ye, Xu Zhang","doi":"10.12455/j.issn.1671-7104.230398","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230398","url":null,"abstract":"<p><p>Cardiopulmonary exercise testing (CPET) refers to a method of measuring various indicators of the human body under gradually increasing exercise loads to objectively evaluate cardiopulmonary reserve function and exercise endurance. Currently, CPET detection systems primarily measure subjects' ECG, respiratory flow, oxygen (O <sub>2</sub>), and carbon dioxide (CO <sub>2</sub>) parameters. This paper introduces a non-invasive multi-parameter exercise cardiopulmonary function evaluation system that incorporates impedance cardiography monitoring. The system integrates impedance cardiography monitoring with conventional CPET detection parameters and detects changes in the hemodynamic parameters of the body during exercise, aiding in the evaluation of exercise capacity. Additionally, the system features a portable design with Wi-Fi wireless transmission, which enhances its applicability.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"664-669"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
中国医疗器械杂志Pub Date : 2024-11-30DOI: 10.12455/j.issn.1671-7104.240190
Minliang Zhou, Ming Meng, Meikui Tong
{"title":"[The Current Status and Suggestions of Registration Quality System Audit for Entrusted Production According to Shanghai Medical Device Regulation of Marketing Authorization Holder].","authors":"Minliang Zhou, Ming Meng, Meikui Tong","doi":"10.12455/j.issn.1671-7104.240190","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240190","url":null,"abstract":"<p><p>This study expounds on the current status of the registration quality system audit for entrusted production in the past three years in accordance with Shanghai's medical device regulations for marketing authorization holders (MAH). Through sorting and analyzing typical non-conformities, highlighting the main responsibilities of registrants, and clarifying the obligations and rights of relevant parties. Meanwhile, it also provides a certain useful reference for medical device marketing authorization holders and relevant regulators.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"683-688"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
中国医疗器械杂志Pub Date : 2024-11-30DOI: 10.12455/j.issn.1671-7104.240168
Jianxiu Zhu, Zhichen Zhai
{"title":"[Analysis on Evaluation Method of Mechanically-Induced Hemolysis of Medical Devices].","authors":"Jianxiu Zhu, Zhichen Zhai","doi":"10.12455/j.issn.1671-7104.240168","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240168","url":null,"abstract":"<p><p>Mechanically-induced hemolysis is an important index for evaluating the blood compatibility of medical devices. It mainly evaluates the risk of mechanical hemolysis under simulated clinical use conditions of medical devices. The existing hemolysis test standards mainly evaluate the risk of material-induced hemolysis and cannot evaluate the risk of mechanically-induced hemolysis. Although some institutions have conducted research on mechanically-induced hemolysis caused by medical devices, systematic evaluation standards have not yet been established. This study mainly summarizes the evaluation process, selection of evaluation models, and steps for assessing mechanically-induced hemolysis, providing a reference for relevant evaluations and standard establishment.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"689-693"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
中国医疗器械杂志Pub Date : 2024-11-30DOI: 10.12455/j.issn.1671-7104.240069
Fan Wang, Jiansong Xia, Hui Yang, Guofei Yan, Jiaying He, Liqiang Wang
{"title":"[Development and Clinical Application of High-Magnification Electronic Endoscope].","authors":"Fan Wang, Jiansong Xia, Hui Yang, Guofei Yan, Jiaying He, Liqiang Wang","doi":"10.12455/j.issn.1671-7104.240069","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240069","url":null,"abstract":"<p><p>This article introduces a high-magnification electronic endoscope system that utilizes a continuous zoom optical design, enabling high-magnification imaging at the cellular level. By selecting an appropriate initial retrofocus structure, the optimized modulation transfer function (MTF) curve of the zoom objective lens approaches the diffraction limit. Additionally, the tip and operation parts of the system incorporate modular gas-tight sealing and multiple layers of protective structure. The design employs efficient sealing materials and precise packaging techniques to ensure the system's sealing performance. The experimental results indicate that, under conventional imaging, the resolution is equivalent to 39.37 μm in object space, and the field of view angle is larger than 140 degrees. At magnified imaging, the resolution is equivalent to 2.78 μm in object space, and the observed actual field of view is greater than 800 μm×700 μm. When used with a 26-inch display monitor, the high-magnification electronic endoscope can achieve 500× optical magnification, allowing for the observation of features at the cellular level. Currently, this product has successfully achieved mass production and has undergone multiple animal trials, demonstrating its wide range of potential applications and significant clinical value.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"658-663"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
中国医疗器械杂志Pub Date : 2024-11-30DOI: 10.12455/j.issn.1671-7104.240071
Chengchen Chu, Wei Jin, Ruiyao Jiang
{"title":"[Research on Evaluation System of Medical Imaging Equipment Dynamic Acquisition Technology Based on Multiple Criteria Decision Analysis].","authors":"Chengchen Chu, Wei Jin, Ruiyao Jiang","doi":"10.12455/j.issn.1671-7104.240071","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240071","url":null,"abstract":"<p><strong>Objective: </strong>To construct an evaluation model system for dynamic data acquisition methods of medical imaging equipment in hospitals. The analytic hierarchy process (AHP) of the multiple criteria decision analysis method is used to study the model.</p><p><strong>Methods: </strong>Through multi-criteria decision analysis, the evaluation index system of dynamic data acquisition technology of medical imaging equipment is constructed from aspects such as the reliability and traceability of data acquisition, the interactivity of the acquisition mode, and the extensibility of application analysis.</p><p><strong>Results: </strong>A hierarchical evaluation model of dynamic acquisition technology for medical imaging equipment is constructed, which includes 5 primary indexes, 14 secondary indexes, and 38 tertiary indexes.</p><p><strong>Conclusion: </strong>We have constructed a qualitative and quantitative evaluation index for the dynamic acquisition technology of medical imaging equipment. The weight of the quantitative index \"reliability\" is 30%, and the weights of the qualitative indexes \"security\", \"traceability\", \"interactivity\", and \"scalability\" are 25%, 20%, 15%, and 10% respectively. It can be used to study the methods and technical characteristics of three kinds of dynamic data acquisition of medical equipment and form a technical evaluation scheme for dynamic data acquisition.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"652-657"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
中国医疗器械杂志Pub Date : 2024-11-30DOI: 10.12455/j.issn.1671-7104.240183
Yu Chen, Zehui Sun, Xianliang He, Changgen Chen, Bingbing Xue, Libin Meng, Ye Li
{"title":"[Key Techniques of Three-Dimensional Electrophysiology Catheter Positioning Based on Magnetic-Electric Fusion].","authors":"Yu Chen, Zehui Sun, Xianliang He, Changgen Chen, Bingbing Xue, Libin Meng, Ye Li","doi":"10.12455/j.issn.1671-7104.240183","DOIUrl":"10.12455/j.issn.1671-7104.240183","url":null,"abstract":"<p><p>In cardiac ablation procedures, the accuracy of catheter positioning determines the authenticity of the cardiac model and the accuracy of the ablation target. This article reviews the literature on catheter positioning in electrophysiology and summarizes the key technologies for catheter positioning, such as magnetic-electric fusion and interference suppression. Addressing the limitations of electric and magnetic positioning individually, the paper elaborates on the rationale for catheter positioning technology based on magnetic-electric fusion. It also outlines the framework of a complex catheter positioning system. Specifically, the magnetoelectric conversion matrix is established first, followed by the optimization of the catheter shape. The interference factors such as magnetic field interference, body movement, respiration, and heartbeat in catheter positioning and their suppression methods are analyzed and discussed in detail. Finally, the development trend of three-dimensional electrophysiology catheter positioning technology is prospected, offering feasible insights for the research on catheter positioning technology based on magnetic-electric fusion.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"631-638"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}