中国医疗器械杂志最新文献

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[Quantitative Study on Morphological Parameters of Healthy Cervical Spinal Cord Based on SCT]. 基于SCT的健康颈脊髓形态学参数定量研究
中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240337
Wei Jin, Hao Liu, Ruiyao Jiang, Guangqi Liu
{"title":"[Quantitative Study on Morphological Parameters of Healthy Cervical Spinal Cord Based on SCT].","authors":"Wei Jin, Hao Liu, Ruiyao Jiang, Guangqi Liu","doi":"10.12455/j.issn.1671-7104.240337","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240337","url":null,"abstract":"<p><strong>Objective: </strong>To utilize Spinal Cord Toolbox (SCT) to measure the morphological parameters of healthy cervical spinal cords and explore the impact of gender, age and vertebral levels on them.</p><p><strong>Methods: </strong>A retrospective study was conducted, collecting cervical spinal cord magnetic resonance images of 184 healthy adults. Then, cross-sectional area (CSA), eccentricity, antero-posterior diameter (AP) and right-left diameter (RL) were each computed for every subject. Then, impacts of gender, age and vertebral level on CSA and eccentricity were explored. Moreover, linear correlation analysis was conducted among CSA, AP and RL.</p><p><strong>Results: </strong>The CSA of the cervical spinal cord in males was significantly larger than that in females at C2~C7 segments (<i>P</i><0.05) . For C2~C6 segments, there was no statistically significant difference in CSA between the young and middle-aged groups, but both were significantly larger than that of the elderly group. CSA of C4 was the largest whereas CSA of C7 was the smallest. Eccentricity values of C4 and C5 were significantly larger than those of other vertebral levels (<i>P</i><0.05). Linear correlation was established between CSA, AP and RL at C2~C7 segments.</p><p><strong>Conclusion: </strong>The results allow for minimizing inter-subject variability using normalization, and thereby highlighting the importance of morphological parameters as biomarkers in the research of cervical spinal lesions.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"141-147"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144039325","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
[Discussion on Registration Evaluation Concerns of Embolic Microsphere Devices]. 【栓塞微球器械注册评价问题探讨】。
中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240422
Xiangmei Zhang, Yidan Zhang, Xiaoqi Lian
{"title":"[Discussion on Registration Evaluation Concerns of Embolic Microsphere Devices].","authors":"Xiangmei Zhang, Yidan Zhang, Xiaoqi Lian","doi":"10.12455/j.issn.1671-7104.240422","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240422","url":null,"abstract":"<p><p>The structural characteristics and clinical application of embolic microspheres were summarized in this paper. According to evaluation experience and current regulatory registration evaluation requirements, registration evaluation concerns on embolic microsphere as medical device were analyzed from four aspects: administration attributes, product description, non-clinical studies and clinical evaluation, in order to provide references for the development and registration application of such products and improve the efficiency of registration application.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"224-229"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144026350","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 of the Core Principles and Key Design and Development Control Factors of Two Typical Point-of-Care Testing Technologies]. [两种典型护理点检测技术的核心原理及关键设计开发控制因素分析]。
中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240318
You Zhou, Xin Liu
{"title":"[Analysis of the Core Principles and Key Design and Development Control Factors of Two Typical Point-of-Care Testing Technologies].","authors":"You Zhou, Xin Liu","doi":"10.12455/j.issn.1671-7104.240318","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240318","url":null,"abstract":"<p><p>Point-of-care testing (POCT), as an emerging diagnostic technology, is gradually becoming an important part of the clinical diagnostic field due to its advantages, such as ease of operation, rapid response, and portability. This paper primarily introduces two mainstream technologies in POCT: lateral flow assays and nucleic acid amplification. It covers the basic principles, applications, and quality control points in design and development of the two mainstream technologies, aiming to provide a technical reference for device manufacturers, researchers, and regulatory agencies.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"230-236"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144065072","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
[Simulation Study of Myocardial Tissue Ablation Effects Using Flower Petal-Structured Electrodes in Pulsed Ablation]. 花瓣结构电极脉冲消融心肌组织效应的模拟研究
中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240484
Lingfeng Lu, Huiming Chen
{"title":"[Simulation Study of Myocardial Tissue Ablation Effects Using Flower Petal-Structured Electrodes in Pulsed Ablation].","authors":"Lingfeng Lu, Huiming Chen","doi":"10.12455/j.issn.1671-7104.240484","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240484","url":null,"abstract":"<p><p>This study aims to evaluate the application of flower petal-structured electrodes in pulsed field ablation (PFA) technology, with a particular focus on their performance in myocardial tissue ablation. Through a combination of simulation techniques and <i>in vitro</i> experiments, the study investigates the effects of different voltage levels, electrode-to-tissue contact distances, and their impact on ablation depth, continuity, and transmurality. The research methods include the construction of a myocardial tissue simulation model, electric field distribution simulation using COMSOL Multiphysics, and <i>in vitro</i> ablation experiments on potato tissue. The results indicate that as voltage increases, the ablation depth significantly increases. At a voltage of 2500 V, a transmural ablation depth of 4 mm can be achieved, and the ablation area remains relatively continuous. The <i>in vitro</i> experiments confirm the consistency of the simulation results, and pulsed field ablation does not induce significant temperature rise, confirming its non-thermal characteristic. The conclusion suggests that PFA technology requires less electrode contact and offers higher ablation efficiency, providing a new technological pathway for the clinical treatment of atrial fibrillation and effectively reducing the risk of complications associated with traditional ablation techniques.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"125-133"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144021578","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
[Exploration and Practice of Performance Evaluation System for Large Medical Equipment Based on Internet of Things Technology]. [基于物联网技术的大型医疗设备性能评价体系探索与实践]。
中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240684
Chang Su, Caixian Zheng, Linling Zhang, Yunming Shen, Kai Fan, Tingting Dong, Hangyan Zhao, Xiaofeng Wang, Dawei Qiao, Kun Zheng
{"title":"[Exploration and Practice of Performance Evaluation System for Large Medical Equipment Based on Internet of Things Technology].","authors":"Chang Su, Caixian Zheng, Linling Zhang, Yunming Shen, Kai Fan, Tingting Dong, Hangyan Zhao, Xiaofeng Wang, Dawei Qiao, Kun Zheng","doi":"10.12455/j.issn.1671-7104.240684","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240684","url":null,"abstract":"<p><p>Medical equipment, as an important indicator of smart hospital evaluation, plays a vital role in hospital operations. To ensure the safe and efficient operation of medical equipment, a reasonable performance evaluation system is indispensable. This study introduces a platform based on Internet of Things (IoT) technology that connects medical devices and collects data, achieving standardized and structured data processing, and supporting online operational supervision. Through the Delphi method, a performance evaluation system for large medical equipment is constructed, including 4 primary indicators and 22 secondary indicators. DICOM data acquisition devices are used to achieve functions such as efficiency analysis, benefit analysis, usage evaluation, and decision-making support for medical equipment. The study is still in its early stages, and in the future, it is expected to integrate more types of equipment, achieve rational resource allocation, and significantly impact decision-making for the development of public hospitals.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"191-196"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144057984","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
[Advances in 3D Printing Technology for Bolus in Radiation Therapy]. 【3D打印技术在放射治疗中的应用进展】
中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 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}
引用次数: 0
[Segmented Time Study and Optimization Strategy for Clinical Application of Ethos Online Adaptive Radiotherapy]. Ethos在线自适应放疗临床应用的分段时间研究及优化策略
中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240389
Dandan Zhang, Yuhan Kou, Shilong Zhu, Xiaoyu Liu, Meng Ning, Peichao Ban, Jinyuan Wang, Changxin Yan, Zhongjian Ju
{"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}
引用次数: 0
[Method of Reducing Low-Dose Lung Volume in VMAT on Central Lung Cancer Planning]. [降低VMAT低剂量肺容积对中枢性肺癌规划的影响]。
中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 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}
引用次数: 0
[Design and Verification of a Human Energy Metabolism Detection System Based on Breath-by-Breath Method]. 基于呼吸法的人体能量代谢检测系统的设计与验证
中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 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}
引用次数: 0
[Progress in Application of Novel Functional Hemostatic Dressings in Patients with Continuous Bleeding after PICC Catheterization]. [新型功能性止血敷料在PICC置管后持续出血中的应用进展]。
中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240317
Jimin Wu, Qiong Yan, Haiying Xu, Xiaohong Zhang, Xinyue Li, Jinlei Du
{"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}
引用次数: 0
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