中国医疗器械杂志最新文献

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[Application of CT Radiomics in Predicting Differentiation Level of Lung Adenocarcinoma]. [CT放射组学在预测肺腺癌分化水平中的应用]。
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 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}
引用次数: 0
[Comparative Evaluation of Encephalon State Index and Bispectral Index in Monitoring the Depth of Anesthesia during the Surgical Anesthesia Stage]. [手术麻醉阶段脑状态指数与双谱指数监测麻醉深度的比较评价]。
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 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}
引用次数: 0
[Development of Multi-Parameter Exercise Cardiopulmonary Function Evaluation System with Impedance Cardiogram Monitoring]. [阻抗心电图监测多参数运动心肺功能评价系统的研制]。
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 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}
引用次数: 0
[The Current Status and Suggestions of Registration Quality System Audit for Entrusted Production According to Shanghai Medical Device Regulation of Marketing Authorization Holder]. 《上海市医疗器械上市许可持有人委托生产注册质量体系审核现状及建议》。
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 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}
引用次数: 0
[Analysis on Evaluation Method of Mechanically-Induced Hemolysis of Medical Devices]. [医疗器械机械溶血评价方法分析]。
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 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}
引用次数: 0
[Development and Clinical Application of High-Magnification Electronic Endoscope]. 高倍率电子内窥镜的研制与临床应用
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 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}
引用次数: 0
[Key Techniques of Three-Dimensional Electrophysiology Catheter Positioning Based on Magnetic-Electric Fusion]. [基于磁电融合的三维电生理导管定位关键技术]。
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 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}
引用次数: 0
[Research on Evaluation System of Medical Imaging Equipment Dynamic Acquisition Technology Based on Multiple Criteria Decision Analysis]. 基于多准则决策分析的医学影像设备动态采集技术评价体系研究
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 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}
引用次数: 0
[Research Progress on Medical Imaging and New Ultrasound Techniques for Assessing the Degree of Carotid Artery Stenosis]. 颈动脉狭窄程度的医学影像学及超声新技术研究进展
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.240137
Yigang Du, Shengli Wang, Zhaoling Lu, Yanbo Liu, Yuexin Guo, Xing An, Shuangshuang Li, Lei Zhu
{"title":"[Research Progress on Medical Imaging and New Ultrasound Techniques for Assessing the Degree of Carotid Artery Stenosis].","authors":"Yigang Du, Shengli Wang, Zhaoling Lu, Yanbo Liu, Yuexin Guo, Xing An, Shuangshuang Li, Lei Zhu","doi":"10.12455/j.issn.1671-7104.240137","DOIUrl":"10.12455/j.issn.1671-7104.240137","url":null,"abstract":"<p><p>The paper summarizes the imaging evaluation methods for assessing the degree of carotid artery stenosis and analyzes the unique advantages and limitations of various imaging techniques in vascular imaging based on existing guidelines and consensus. The paper focuses on reviewing the clinical applications of several novel ultrasound technologies, including the use of advanced hemodynamic parameters such as blood flow dispersion (Tur index) and wall shear stress (WSS). Carotid artery stenosis is closely associated with cardiovascular disease. Although non-invasive and radiation-free ultrasound technology has certain limitations in diagnostic accuracy to a certain extent, with the continuous emergence of advanced functions such as ultrasound hemodynamics and vascular elasticity, the combination of multi-modality and multi-parameter ultrasound is expected to become an important method for efficient diagnosis of arterial stenosis in the future.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"624-630"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787757","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}
引用次数: 0
[Analysis and Perspectives of MRI-Guided Proton Therapy Integrated Technology]. 磁共振引导质子治疗综合技术分析与展望
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.240110
Xiaowa Wang, Lan Wang, Weiming Sun
{"title":"[Analysis and Perspectives of MRI-Guided Proton Therapy Integrated Technology].","authors":"Xiaowa Wang, Lan Wang, Weiming Sun","doi":"10.12455/j.issn.1671-7104.240110","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240110","url":null,"abstract":"<p><p>This article explores the MRI-guided proton therapy (MRiPT) integrated technology, which is magnetic resonance imaging-guided radiation therapy. By precisely controlling dose distribution, MRiPT has the potential to enhance the efficacy of radiotherapy. This article reviews the development of MRiPT, analyzes its potential for clinical application, and discusses technical challenges and potential solutions. MRiPT technology offers significant advantages in improving treatment precision and reducing side effects, especially showing exceptional potential in the treatment of complex tumors. This article concludes by looking forward to the future development of MRiPT technology, emphasizes the importance of optimizing electromagnetic compatibility and reducing inter-system interference.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"618-623"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787691","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}
引用次数: 0
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