中国医疗器械杂志Pub Date : 2025-03-30DOI: 10.12455/j.issn.1671-7104.240410
Yu Cheng, Haiyan Peng, Fu Jin, Xu Ma
{"title":"[Advances in 3D Printing Technology for Bolus in Radiation Therapy].","authors":"Yu Cheng, Haiyan Peng, Fu Jin, Xu Ma","doi":"10.12455/j.issn.1671-7104.240410","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240410","url":null,"abstract":"<p><p>3D printing technology, with a layer-by-layer construction method, enables the fabrication of intricately shaped and customizable bolus. In contrast to traditional preparation methods, 3D printing technology addresses challenges such as poor bolus fit and cumbersome production processes, offering a novel approach to efficient and personalized bolus fabrication. This article discusses the research progress of 3D printing technology in radiotherapy bolus from aspects such as the preparation process, clinical application, and research advancements, combined with the actual printing experience of Department of Radiation Oncology in Chongqing University Cancer Hospital.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"154-160"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144058095","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}
{"title":"[Segmented Time Study and Optimization Strategy for Clinical Application of Ethos Online Adaptive Radiotherapy].","authors":"Dandan Zhang, Yuhan Kou, Shilong Zhu, Xiaoyu Liu, Meng Ning, Peichao Ban, Jinyuan Wang, Changxin Yan, Zhongjian Ju","doi":"10.12455/j.issn.1671-7104.240389","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240389","url":null,"abstract":"<p><strong>Objective: </strong>To analyze the time characteristics of the Ethos online adaptive radiotherapy (OART) process in clinical practice and provide guidance for the comprehensive optimization of each stage of adaptive radiotherapy.</p><p><strong>Methods: </strong>The study involved 61 patients with cervical, rectal, gastric, lung, esophageal, and breast cancers who underwent Ethos OART. The mean ± standard deviation of segmental time, total time, and target volume for these patients were tracked. The time characteristics for different cancer types were evaluated, and the average time for target and organ at risk (OAR) modifications was compared with the average target volume for each cancer type.</p><p><strong>Results: </strong>Cervical cancer born the longest total treatment time, while breast cancer had the shortest. For all cancer types except breast cancer, the modification time for target and OAR was the most time-consuming segment. The average time for target and OAR modifications aligned with the trend of the average target volume.</p><p><strong>Conclusion: </strong>The total treatment time for various cancers ranges from 15 to 35 minutes, indicating room for improvement.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"134-140"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143991747","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 : 2025-03-30DOI: 10.12455/j.issn.1671-7104.240237
Haojia Zhang, Yi Zhang, Haijie Jin, Shihu You, Jiaying Gan, Yinxiang Hu
{"title":"[Method of Reducing Low-Dose Lung Volume in VMAT on Central Lung Cancer Planning].","authors":"Haojia Zhang, Yi Zhang, Haijie Jin, Shihu You, Jiaying Gan, Yinxiang Hu","doi":"10.12455/j.issn.1671-7104.240237","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240237","url":null,"abstract":"<p><strong>Objective: </strong>To study effective methods for reducing lung <i>V</i><sub>5</sub>, <i>V</i><sub>10</sub>, and mean lung dose (MLD) in the design of volumetric modulated arc therapy for central lung cancer by using different arc configurations and dose-limiting blocks designs.</p><p><strong>Methods: </strong>Five groups of plans were designed for the enrolled patients. Group A used a full-arc field. Group B used a partial-arc field. Groups C, D, and E used full-arc fields with vertical-length, semi-ring, and triangular dose-limiting blocks added respectively. The dosimetric similarities of target areas and the dosimetric differences in lung <i>V</i><sub>5</sub>, <i>V</i><sub>10</sub>, <i>V</i><sub>20</sub>, and MLD among the groups were compared.</p><p><strong>Results: </strong>Compared with group A, groups B, C, D, and E had decreased homogeneity and conformity of the target area, but significantly lower <i>V</i><sub>5</sub> and <i>V</i><sub>10</sub> of the whole lung. The MLD of groups C, D, and E was lower than that of group A.</p><p><strong>Conclusion: </strong>Using a full-arc field combined with dose-limiting blocks can effectively reduce lung <i>V</i><sub>5</sub>, <i>V</i><sub>10</sub>, MLD, and monitor units (MU).</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"181-185"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144032839","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 : 2025-03-30DOI: 10.12455/j.issn.1671-7104.240546
Chendong Li, Wei Fang, Youcai Wang, Yanyan Chen, Wei Cao, Jun Xu, Yuyang Wang, Fei Yang, Zijun He, Yining Sun
{"title":"[Design and Verification of a Human Energy Metabolism Detection System Based on Breath-by-Breath Method].","authors":"Chendong Li, Wei Fang, Youcai Wang, Yanyan Chen, Wei Cao, Jun Xu, Yuyang Wang, Fei Yang, Zijun He, Yining Sun","doi":"10.12455/j.issn.1671-7104.240546","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240546","url":null,"abstract":"<p><strong>Objective: </strong>To accurately measure human energy metabolism with high temporal resolution, a respiratory gas analysis system was designed using a breath-by-breath approach.</p><p><strong>Methods: </strong>Firstly, indirect calorimetry was employed in respiratory gas analysis to measure the respiratory flow and concentration signals in real-time. Secondly, oxygen consumption <math><msub><mi>Q</mi><mrow><msub><mrow><mrow><mi>O</mi></mrow></mrow><mn>2</mn></msub></mrow></msub></math> and carbon dioxide production <math><msub><mi>Q</mi><mrow><msub><mrow><mrow><mi>C</mi><mi>O</mi></mrow></mrow><mn>2</mn></msub></mrow></msub></math> were calculated through respiratory characteristic alignment and respiratory signal segmentation. Finally, metabolic indexes were calculated according to the Weir formula. Furthermore, a controlled trial was formulated for validation comparisons with the MGC ULTIMA SYSTEM PFX CARDIO2.</p><p><strong>Results: </strong>The results indicate that the data points of metabolic indexes measured by this system all fall within the confidence interval when compared with those of the MGC.</p><p><strong>Conclusion: </strong>The system has high consistency with the MGC measurement results. Thus, the system can accurately measure metabolism in real-time and provide data support for clinical nutrition assessment and therapy.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"197-203"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144009056","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}
{"title":"[Progress in Application of Novel Functional Hemostatic Dressings in Patients with Continuous Bleeding after PICC Catheterization].","authors":"Jimin Wu, Qiong Yan, Haiying Xu, Xiaohong Zhang, Xinyue Li, Jinlei Du","doi":"10.12455/j.issn.1671-7104.240317","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240317","url":null,"abstract":"<p><p>The high incidence of bleeding after peripherally inserted central catheter (PICC) catheterization increases the risk of puncture site infection and unplanned extubation. Hemostatic dressings should be used in the early stages of catheterization to reduce blood infiltration. However, new hemostatic dressings have various types and advantages, which makes them difficult to choose dressings for medical staff. This paper introduces the types and hemostatic characteristics of novel functional hemostatic dressings, reviews the hemostatic mechanism and hemostatic effect of chitosan, cyanoacrylate gum, alginate, gelatin sponge and oxycellulose dressings in PICC puncture respectively, and prospects the development of new functional hemostatic dressings. It is expected that future hemostatic dressings will move towards multifunctionality and compositeness.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"169-175"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144040302","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 : 2025-03-30DOI: 10.12455/j.issn.1671-7104.240316
Jie Yang, Xiaomin Ren, Jinning Zhang
{"title":"[Exploration of Rational Use of DSA Equipment in IoT and Clinical Service].","authors":"Jie Yang, Xiaomin Ren, Jinning Zhang","doi":"10.12455/j.issn.1671-7104.240316","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240316","url":null,"abstract":"<p><strong>Objective: </strong>This study aims to address the configuration and efficiency issues in the use of digital subtraction angiography (DSA) equipment through the practical implementation of a rationalization platform based on the Internet of Things (IoT).</p><p><strong>Methods: </strong>By employing IoT and data integration technologies, the deep integration of DSA equipment operational data with clinical data was achieved to construct a knowledge base for rational use of DSA equipment. Simultaneously, a knowledge base was developed using software engineering techniques to visually display data analysis results.</p><p><strong>Results: </strong>Through thorough data analysis, an imbalance in DSA usage between the southern and northern hospital campuses was identified. Addressing this issue, optimizations were implemented based on the data analysis results, which ultimately yielded significant effects. These adjustments not only effectively alleviated the pressure on DSA equipment usage in the southern campus, but also increased equipment utilization in the northern district (the average daily working hours have increased from 4.64 h to 7.19 h), shortened patient appointment wait time (the appointment duration in the southern campus decreased by 21.86% year-on-year, while the appointment duration in the northern campus decreased by 20.51% year-on-year).</p><p><strong>Conclusion: </strong>Through the practical implementation of a DSA rationalization platform based on IoT, this study not only successfully explored methods for rational DSA usage but also provided valuable reference for the rational management of medical equipment.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"186-190"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144040418","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 : 2025-03-30DOI: 10.12455/j.issn.1671-7104.240382
Yanan Liu, Xuedong Song, Qi Yin, Fuhao Kang, Yan Hang, Jilun Ye, Xu Zhang
{"title":"[Development of a Microstream End-Tidal Carbon Dioxide Monitoring System with Integrated Gas Circuit].","authors":"Yanan Liu, Xuedong Song, Qi Yin, Fuhao Kang, Yan Hang, Jilun Ye, Xu Zhang","doi":"10.12455/j.issn.1671-7104.240382","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240382","url":null,"abstract":"<p><p>End-tidal carbon dioxide monitoring is an important means of evaluating human lung function and is widely used in fields such as clinical emergency treatment and cardiopulmonary resuscitation. This paper develops a microstream end-tidal carbon dioxide monitoring system. It adopts an integrated gas circuit design to further reduce the size of the equipment. The system uses the method of calculating the root mean square (RMS) of differential pressure signals to regulate the gas circuit flow, enabling the system to stably operate at a flow state of 30 mL/min. In addition, by simultaneously detecting multiple environmental parameters such as temperature and pressure, the system realizes system state monitoring and gas parameter compensation. The test results show that various indicators of the system meet the requirements of relevant standards, laying a good foundation for subsequent engineering applications.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"204-211"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144038933","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 : 2025-03-30DOI: 10.12455/j.issn.1671-7104.240397
Ting He, Ru Bai, Neng Xie
{"title":"[Brief Discussion on the General Requirements of Quality Management System of <i>In Vitro</i> Diagnostic Reagents Developed by Medical Institutions].","authors":"Ting He, Ru Bai, Neng Xie","doi":"10.12455/j.issn.1671-7104.240397","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240397","url":null,"abstract":"<p><p>On March 19, 2021, the National Medical Products Administration(NMPA) issued the <i>Regulations on the Supervision and Administration of Medical Devices</i> (Order No. 739 of the State Council of the People's Republic of China), which clearly stipulated in Article 53 the basic definition and scope of use of <i>in vitro</i> diagnostic reagents developed by medical institutions. It also pointed out that the relevant administrative measures shall be formulated by the Drug Regulatory Department of the State Council in conjunction with the Health Department of the State Council. This initiative marks the re-incorporation of <i>in vitro</i> diagnostic reagents developed by medical institutions into China's regulatory system. This study reviewed the development of regulatory policies for self-developed <i>in vitro</i> diagnostic reagents at home and abroad, combined with the <i>Key Points of On-site Verification of Self-developed In Vitro Diagnostic Reagents in Shanghai Medical Institutions</i> issued by the Shanghai Municipal Drug Administration, in conjunction with the Shanghai Municipal Health Commission, and the specific verification work of pre-record evaluation, and sorted out the general requirements for the quality management system of self-developed <i>in vitro</i> diagnostic reagents. The purpose is to provide some references for the further development of this pilot work and its nationwide promotion.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"219-223"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144018147","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}
{"title":"[Three-Dimensional Reconstruction Technique and Its Application of Binocular Endoscopic Images Based on Deep Learning].","authors":"Lina Huang, Shenglin Liu, Qingmin Feng, Haolong Jin, Qiang Zhang","doi":"10.12455/j.issn.1671-7104.240293","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240293","url":null,"abstract":"<p><p>The clinical application of binocular endoscope relies primarily on the visual system of physicians to create a three-dimensional effect, but it cannot provide accurate depth information. The utilization of 3D reconstruction technology in binocular endoscopy can facilitate the recovery of image depth information, and the application of deep learning-based 3D reconstruction technology can significantly improve the accuracy and real-time performance of reconstruction results, making it widely applicable in the realm of minimally invasive surgery. This paper aims to explore the key technologies and implementation methods of deep learning based 3D reconstruction for binocular endoscopic images, and seeks to outline strategies for enhancing the quality of 3D reconstruction in endoscopic images, providing guidance for sustainable development of binocular endoscopic image reconstruction technology in clinical settings. This will assist in the application of minimally invasive surgery and contribute to meeting the demands of precision medicine.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"161-168"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144050817","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 : 2025-03-30DOI: 10.12455/j.issn.1671-7104.240458
Juan Shen, Wei Liu
{"title":"[Finite Element Simulation Analysis of a Nickel-Titanium Alloy Patent Foramen Ovale Occluder].","authors":"Juan Shen, Wei Liu","doi":"10.12455/j.issn.1671-7104.240458","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240458","url":null,"abstract":"<p><p>In this paper, a preliminary stress/strain analysis of the design structure of a nickel-titanium alloy patent foramen ovale occluder is conducted with the finite element simulation analysis method. In the analysis, solid structure modeling is carried out on three different specifications of domestic patent foramen ovale occluders. Referring to the test method of fatigue performance in inspection standard YY/T 1553-2017, an initial installation deformation is applied to the model, and then the fatigue displacement of 2 mm is applied to the sample to make the model fatigue deformation. The fatigue safety factors of each type of occluder are obtained by strain simulation analysis. The results indicate that the minimum fatigue safety factors of the three specifications of domestic patent foramen ovale occluders are 2.09, 2.35 and 2.06 respectively, which all meet the design of fatigue safety factor greater than 1. Among them, 1818 and 3030 specifications of patent foramen ovale occluders have close values in minimum fatigue safety factors, and both are lower than that of 1825 model. Therefore, it is recommended to carry out physical fatigue tests on both 1818 and 3030 specifications to further verify the fatigue performance of the products.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"119-124"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144057118","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}