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[Analysis on Evaluation Method of Mechanically-Induced Hemolysis of Medical Devices].
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].
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
[Research on Evaluation System of Medical Imaging Equipment Dynamic Acquisition Technology Based on Multiple Criteria Decision Analysis].
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
[Key Techniques of Three-Dimensional Electrophysiology Catheter Positioning Based on Magnetic-Electric Fusion].
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 Progress on Medical Imaging and New Ultrasound Techniques for Assessing the Degree of Carotid Artery Stenosis].
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
[Performance Evaluation Methods and Suggestions for High-Voltage Generator and Tube of DR System].
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.240066
Hairong Zou
{"title":"[Performance Evaluation Methods and Suggestions for High-Voltage Generator and Tube of DR System].","authors":"Hairong Zou","doi":"10.12455/j.issn.1671-7104.240066","DOIUrl":"10.12455/j.issn.1671-7104.240066","url":null,"abstract":"<p><p>In the design of DR systems, high-voltage generators and X-ray tubes are two key components whose performance directly affects the system's exposure capabilities. This article first explains why it is necessary to conduct an in-depth evaluation of the performance of these two parts during the design of DR products. Then, it provides a detailed description of the evaluation methods, including the assessment of single exposure capability and continuous exposure capability. Finally, the article offers some suggestions and measures to enhance continuous exposure capability. These methods and suggestions not only help in selecting appropriate key components but also provide an important reference for the design, integration, and testing of DR systems.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"613-617"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787753","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
[In Vitro Hydrodynamic Performance Evaluation of Valve Repair System].
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.240172
Liang Cai, Yibin Li, Shiwen Lyu
{"title":"[<i>In Vitro</i> Hydrodynamic Performance Evaluation of Valve Repair System].","authors":"Liang Cai, Yibin Li, Shiwen Lyu","doi":"10.12455/j.issn.1671-7104.240172","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240172","url":null,"abstract":"<p><strong>Objective: </strong>To meet the treatment requirements for mitral regurgitation disease, this study designed a novel valve repair system and evaluated its hydrodynamic performance.</p><p><strong>Methods: </strong>A mitral regurgitation model was created. The valve repair system was loaded onto the regurgitation model, and pulsatile flow tests and steady backflow leakage tests were conducted.</p><p><strong>Results: </strong>The pulsatile flow test results indicated that the percentage of reflux after product implantation was lower than that before implantation under different concentric outputs and reverse pressures. The average cross-valve pressure difference after implantation was less than 5 mmHg. The steady backflow leakage test results showed that as the reverse pressure increased, the leakage amount of the valve repair system after implantation also increased.</p><p><strong>Conclusion: </strong>The developed valve repair system exhibits excellent hydrodynamic performance, suggesting the feasibility of its application in the treatment of clinical mitral regurgitation.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"603-606"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787593","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].
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
[Clinical Application and Clinical Evaluation Concerns of Embolization Microspheres].
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.240205
Jing Liu, Jiaying Guo
{"title":"[Clinical Application and Clinical Evaluation Concerns of Embolization Microspheres].","authors":"Jing Liu, Jiaying Guo","doi":"10.12455/j.issn.1671-7104.240205","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240205","url":null,"abstract":"<p><p>Embolization microspheres can be used for the embolization of hypervascular malignant tumors of parenchymal organs. They can also be used as an adjuvant therapy for surgery to reduce perioperative bleeding through preoperative intravascular embolization of tumors. This study summarizes the clinical guidelines and consensus on embolization microspheres and introduces the guidance document for embolization microspheres issued by the Food and Drug Administration (FDA). Additionally, this study presents the authors' thoughts on clinical review of embolization microspheres, aiming to provide insights for the clinical evaluation and technical review of such products.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"694-698"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787694","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
[Intestinal Polyp Segmentation Based on Histogram Equalization ResNet (PE-ResNet)].
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.240235
Yukun An, Biao Zhang, Ming Yang, Qiyong Lin, Ping Zhou
{"title":"[Intestinal Polyp Segmentation Based on Histogram Equalization ResNet (PE-ResNet)].","authors":"Yukun An, Biao Zhang, Ming Yang, Qiyong Lin, Ping Zhou","doi":"10.12455/j.issn.1671-7104.240235","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240235","url":null,"abstract":"<p><p>Colonoscopy is an important technical means for screening early colorectal cancer lesions. Accurate segmentation of intestinal polyps helps improve the accuracy of screening. Early screening for lesions is of great significance for the prevention of colorectal cancer, and the segmentation of intestinal polyps is an important research direction. Although intestinal polyp segmentation based on deep learning has achieved acceptable performance, the color variation among intestinal endoscopic images significantly affects it. Based on the ResNet architecture, this study proposes an advanced PE-ResNet in which histogram equalization is used to reduce color influence. Experimental results on five datasets, including ClinicDB, demonstrate that the PE-ResNet model achieves improved performance in intestinal polyp segmentation.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"607-612"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787751","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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