中国医疗器械杂志最新文献

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[Comparative Study of Seven New Dressings in Promoting Chronic Wound Healing in db/db Mice]. 7种新型敷料促进db/db小鼠慢性创面愈合的比较研究
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240693
Qiuyun Feng, Jia Ke, Danning Qi, Lei Zhou, Haiguang Chai
{"title":"[Comparative Study of Seven New Dressings in Promoting Chronic Wound Healing in db/db Mice].","authors":"Qiuyun Feng, Jia Ke, Danning Qi, Lei Zhou, Haiguang Chai","doi":"10.12455/j.issn.1671-7104.240693","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240693","url":null,"abstract":"<p><p>This study evaluated the healing-promoting effect and applicability of seven new dressings in chronic wounds. A chronic wound model was established using 48 db/db diabetic mice, which were randomly divided into 8 groups (control, polymer film, alginate, foam, hydrocolloid, hydrogel, carbon fiber, and silver dressing groups). Regular monitoring was conducted on the 5, 10, 15, and 20 days after surgery, and a comprehensive evaluation was performed based on healing rate, characteristic of histopathology, and semi-quantitative scoring. The results showed that, except for the polymer film dressing group, all other dressing groups had significantly better healing-promoting effect than the control group ( <i>P</i><0.05), with the hydrocolloid, carbon fiber, and silver dressing groups demonstrated particularly outstanding efficacy. This study systematically compared the efficacy differences of seven dressings, and combined them with the adhesion, exudate volume and infection risks to provide a scientific basis for clinical dressing selection.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"295-301"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509365","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 MRI Gradient Coil Magnetic Field Induced Eddy Current Method]. 磁共振梯度线圈磁场感应涡流法的研究
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240596
Xiaotao Zhang, Yicheng Li, Zhanping Zheng, Mingke Wang, Like Feng, Congbo Li
{"title":"[Research on MRI Gradient Coil Magnetic Field Induced Eddy Current Method].","authors":"Xiaotao Zhang, Yicheng Li, Zhanping Zheng, Mingke Wang, Like Feng, Congbo Li","doi":"10.12455/j.issn.1671-7104.240596","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240596","url":null,"abstract":"<p><p>After the production of the gradient coil of the magnetic resonance imaging system, electromagnetic field testing is required to verify whether the assembly accuracy meets the electromagnetic field requirements. Since the passive magnetic field <i><b>B</b> <sub>z</sub></i> satisfies the Laplace <sup>,</sup>s equation and is a harmonic function, and according to the extreme value principle of harmonic function, the maximum or minimum values of <i><b>B</b> <sub>z</sub></i> can only appear on the boundaries, so the observation points of the magnetic field are generally selected on the surface of the spherical imaging area. For superconducting magnets used for human body magnetic resonance imaging, a spherical area with a center diameter of 40~50 cm is generally selected as the shimming target area. Only the field value of the target area needs to be measured, and the spherical harmonic coefficients obtained after data processing are used to determine the magnetic field performance of the gradient coil. There are many testing principles and methods for electromagnetic fields, so there is no unified way and method in the field of commercial applications. This article is based on the Gauss-Legendre numerical integration, measures and analyzes the magnetic field performance of gradient coils by building a data acquisition system, and this article applies numerical analysis methods to calculate the spherical harmonic coefficients of the magnetic field using discrete test data, providing a feasible method for the production and testing of gradient coils.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"263-268"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509389","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 Aspects of Performance Evaluation on Droplet Digital PCR Instrument]. [液滴数字PCR仪性能评价关键方面]。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240426
Wen Bao
{"title":"[Key Aspects of Performance Evaluation on Droplet Digital PCR Instrument].","authors":"Wen Bao","doi":"10.12455/j.issn.1671-7104.240426","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240426","url":null,"abstract":"<p><p>From the perspective of performance evaluation, this paper describes briefly the concerns of study on each component module and the entire instrument, clinical items, software, and product testing on droplet digital PCR instruments, including the study methods and quality control requirements. The increase of the research and development efficiency of products and contribute to the promotion of application of digital PCR instruments in clinical laboratories are expected.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"340-343"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509384","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 Classification of Medical Devices with Nanomaterials]. 纳米材料医疗器械分类研究
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240600
Qian Dong, Li Yi, Liyin Wen, Rui Liu, Jinglong Tang, Jiong Zhu
{"title":"[Research on Classification of Medical Devices with Nanomaterials].","authors":"Qian Dong, Li Yi, Liyin Wen, Rui Liu, Jinglong Tang, Jiong Zhu","doi":"10.12455/j.issn.1671-7104.240600","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240600","url":null,"abstract":"<p><p>The rapid development of nanomaterials has brought groundbreaking opportunities for high-quality innovation in medical devices, but it has also become a new challenge for regulatory authorities. How to scientifically and rationally evaluate the risks of medical device products with nanomaterials and establish appropriate regulatory classifications have become critical research priorities. To solve this problem, this study focuses on medical devices with nanomaterials, conducts a comparative analysis of domestic and international regulatory classification policies, reviews the current registration status of related products, and provides recommendations on key considerations for the classification and regulation of medical devices with nanomaterials, which aims at promoting high-quality advancement in China's medical device regulation.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"336-339"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509388","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
[Review on Applications of Deep Learning in Digital Pathological Images]. [深度学习在数字病理图像中的应用综述]。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240499
Chaoyi Lyu, Yuan Xie, Lu Qiu, Lu Zhao, Jun Zhao
{"title":"[Review on Applications of Deep Learning in Digital Pathological Images].","authors":"Chaoyi Lyu, Yuan Xie, Lu Qiu, Lu Zhao, Jun Zhao","doi":"10.12455/j.issn.1671-7104.240499","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240499","url":null,"abstract":"<p><p>Computer-assisted methods for pathological image analysis can improve doctor's efficiency of image reading and diagnostic accuracy, effectively addressing the shortage of pathology diagnostic manpower. With the rapid development of artificial intelligence and digital pathology, deep learning technology has spurred a wealth of research in the field of histopathology. This article reviews the various applications of deep learning in digital pathological image analysis, such as pathological image segmentation, cancer auxiliary diagnosis, and cancer prognosis prediction, and discusses the challenges and solutions in its application. Furthermore, it predicts future trends in deep learning for pathological image analysis and proposes potential research directions.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"237-243"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509393","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
[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
[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
[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
[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
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