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[Application of Artificial Intelligence in Surgical Robotics]. [人工智能在外科机器人中的应用]。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240456
Linghan Zhang, Yuan Lin
{"title":"[Application of Artificial Intelligence in Surgical Robotics].","authors":"Linghan Zhang, Yuan Lin","doi":"10.12455/j.issn.1671-7104.240456","DOIUrl":"10.12455/j.issn.1671-7104.240456","url":null,"abstract":"<p><p>Surgical robots represent one of the important diagnostic and treatment methods in the field of surgery. In recent years, artificial intelligence (AI) has been increasingly used in the field of surgical medicine, especially in the field of robotic-assisted surgery. This article reviews the common modes of AI in surgical robotics, enumerates the surgical robots available in the market, and summarizes some difficulties and challenges in the application of AI in surgical robotics through literature reviews, website visits and investor press releases analysis of target companies.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"244-249"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509364","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 a Multimodal Transcranial Electrical Stimulation System with Integrated Four-Channel EEG Recordings]. [集成四通道脑电图记录的多模态经颅电刺激系统的开发]。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240419
Yan Hang, Chaoyang Wang, Qi Yin, Yanan Liu, Lin Huang, Jilun Ye, Xu Zhang
{"title":"[Development of a Multimodal Transcranial Electrical Stimulation System with Integrated Four-Channel EEG Recordings].","authors":"Yan Hang, Chaoyang Wang, Qi Yin, Yanan Liu, Lin Huang, Jilun Ye, Xu Zhang","doi":"10.12455/j.issn.1671-7104.240419","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240419","url":null,"abstract":"<p><p>In order to improve the effect of transcranial electrical stimulation treatment and realize personalized treatment for patients with varying severity levels, this paper designed an integrated four-channel EEG recording multimodal transcranial electrical stimulation system. This system can conduct real-time monitoring on EEG and related characteristic analysis before stimulation, in stimulation, and after stimulation. This enables physicians and researchers to resolve real-time brain states, evaluate transcranial electrical stimulation effect, and then artificially adjust the stimulation parameters. After relevant testing and verification, the system can select four stimulation modes: TACS, TDCS, TPCS and TRNS, which can output the constant stimulation current of 0.03 mA accuracy in the range of ±2 mA and the stimulation frequency of low frequency of 0~4 kHz (precision of 0.01 Hz) and high frequency 50~100 kHz, which can obtain more accurate EEG signals under stimulation interference, demonstrating a good market application prospect.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"313-322"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509383","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
[A Novel Coronary Knobby Scoring Balloon and Biomechanical Study in Intravascular Dilation]. 一种新型冠状动脉结节评分球囊和血管内扩张的生物力学研究。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240595
Feng Guo, Junmin Guo, Jipeng Chen, Xuemei Duan, Wenkang Zhang
{"title":"[A Novel Coronary Knobby Scoring Balloon and Biomechanical Study in Intravascular Dilation].","authors":"Feng Guo, Junmin Guo, Jipeng Chen, Xuemei Duan, Wenkang Zhang","doi":"10.12455/j.issn.1671-7104.240595","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240595","url":null,"abstract":"<p><p>This study investigated a novel coronary knobby scoring balloon through finite element analysis (FEA) and <i>in vitro</i> anti-slippage testing, evaluating its dilation process under various vascular conditions and comparing it with other balloons. The FEA results indicated that in the cases of healthy artery and diseased artery with different stenosis rates, the stress on the vessels caused by the knobby scoring balloon was significantly smaller than that of the scoring balloon, and was close to that of the plain balloon. <i>In vitro</i> anti-slippage testing showed that the slippage distance of a plain balloon was 0.11±0.06 mm, and there was no slippage for knobby scoring balloon under nominal pressure. Knobby scoring balloon can effectively expand calcified lesion while providing anti-slippage function, and has a lower risk of vascular injury.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"269-275"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509362","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 Testing of Medical Ultrasound Diagnostic Equipment Based on Tissue-Mimicking Phantom]. [基于组织模拟的医用超声诊断设备性能测试]。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240617
Hao Liu, Longyang Jia, Ruiyao Jiang
{"title":"[Performance Testing of Medical Ultrasound Diagnostic Equipment Based on Tissue-Mimicking Phantom].","authors":"Hao Liu, Longyang Jia, Ruiyao Jiang","doi":"10.12455/j.issn.1671-7104.240617","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240617","url":null,"abstract":"<p><p>This study aims to ensure the effectiveness of medical ultrasound diagnostic equipment in clinical applications by testing multiple key performance indicators using tissue-mimicking phantoms and exploring the changes in these performance indicators over time. Firstly, 17 in-service medical ultrasound diagnostic equipments were selected, and their depth of penetration, dead zone, lateral resolution, axial resolution, geometric position error, and cystic focal diameter error were tested according to the verification regulations. In addition, the study retrospectively analyzed the performance testing data of 19 medical ultrasound diagnostic equipments over the past three consecutive years and conducted statistical analysis. Through the testing, all performance indicators of the 17 equipments met the requirements of the verification regulations, indicating that they can stably and reliably provide high-quality ultrasound diagnostic images and data in clinical applications. Meanwhile, retrospective data showed that with the increase with the increase in service life, the resolving ability at the far field of the 19 equipments decreased, and the cystic focal diameter error increased. Therefore, it is recommended that medical institutions establish a regular testing and maintenance system for medical ultrasound diagnostic equipment, conducting regular performance evaluations and maintenance to ensure its good working condition.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"308-312"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509385","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
[Study on Performance of Nebulizer for Pressurized Intraperitoneal Aerosol Chemotherapy]. [加压腹腔喷雾化疗用雾化器的性能研究]。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240696
Lanfeng Zhang, Guangjun Guo, Guibing Hou
{"title":"[Study on Performance of Nebulizer for Pressurized Intraperitoneal Aerosol Chemotherapy].","authors":"Lanfeng Zhang, Guangjun Guo, Guibing Hou","doi":"10.12455/j.issn.1671-7104.240696","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240696","url":null,"abstract":"<p><strong>Objective: </strong>The study investigates the performance parameters of a nebulizer for pressurized intraperitoneal aerosol chemotherapy (PIPAC).</p><p><strong>Methods: </strong>Laser diffraction spectroscopy was used to measure the median droplet diameter ( <i>D</i> <sub>50</sub>) and spray angle during the steady-state aerosol phase.</p><p><strong>Results: </strong>The minimum droplet diameter of aerosol was achieved when using a nozzle of 0.2 mm diameter and 0.07 mm thickness. The nebulizer could not produce steady-state aerosol when the liquid flow rate was less than or equal to 0.3 mL/s. When the liquid flow rate was greater than or equal to 0.5 mL/s, as the working pressure increased, the median particle size gradually decreased and the spray angle gradually increased. When the pressure is greater than or equal to 200 psi（1 psi=6 894.76 Pa）, as the liquid flow rate increased, the spray angle gradually increased. At a flow rate of 0.7 mL/s and working pressure of 300 psi, the median droplet diameter of aerosol <i>D</i> <sub>50</sub> was 16 μm with a spray angle up to 89.2°.</p><p><strong>Conclusion: </strong>As a novel intraperitoneal drug delivery technology, PIPAC requires further research focusing on reducing droplet size, expanding drug distribution, improving tissue permeability, and increasing drug concentration.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"330-335"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509394","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 Efficacy Evaluation of Steam Thermal Ablation System for Liver Tumor]. 肝肿瘤蒸汽热消融系统的设计及疗效评价
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.250114
Wei Wei, Xiaofei Jin, Lidong Xing, Zhiyu Qian, Haotian Wang, Jingqi Song, Kairan Wan
{"title":"[Design and Efficacy Evaluation of Steam Thermal Ablation System for Liver Tumor].","authors":"Wei Wei, Xiaofei Jin, Lidong Xing, Zhiyu Qian, Haotian Wang, Jingqi Song, Kairan Wan","doi":"10.12455/j.issn.1671-7104.250114","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.250114","url":null,"abstract":"<p><p>To address the limitations of traditional minimally invasive thermal ablation technology such as poor conformability, carbonization and electromagnetic radiation, this paper proposes a steam thermal ablation technology that uses saturated steam internal energy to replace the traditional electromagnetic radiation energy. Through the steam thermal ablation system and the steam thermal ablation needle designed based on simulation, the <i>ex vivo</i> pig liver experiments were carried out. The results have the characteristics of the maximum ablation axis ratio (short diameter / long diameter) and non-carbonization with the same type of thermal ablation technology. Based on the near-infrared light, in this paper the curative effect of the reduced scattering coefficient of the steam thermal ablation results was evaluated. The reduced scattering coefficients of the coagulation area all exceeded 16, reaching the completely damaged state, which verified that the steam thermal ablation can effectively inactivate the tumor cells.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"323-329"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509366","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
[Determination of Acetate Content in Hemodialysis Solutions and Dialysis Concentrates by HPLC]. [HPLC法测定血液透析液和透析浓缩液中醋酸盐含量]。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240718
Huadong Wang, Yue Wang, Dong Liu, Xianghui Liu
{"title":"[Determination of Acetate Content in Hemodialysis Solutions and Dialysis Concentrates by HPLC].","authors":"Huadong Wang, Yue Wang, Dong Liu, Xianghui Liu","doi":"10.12455/j.issn.1671-7104.240718","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240718","url":null,"abstract":"<p><p>This study establishes a high-performance liquid chromatography (HPLC) method for the determination of acetate content in hemodialysis solutions and dialysis concentrates. In this study, Synergi Polar-RP column is utilized. Phosphate buffered saline (50 mmol/L, pH=2.5) is used as a mobile phase. The flow rate is 1.0 mL/min. The wavelength of detection is 212 nm. Results show that the linear relationship of acetate is good in the range of 0.1~20 mmol/L, <i>r</i> =0.999 9 and the spike recoveries are from 98.9%~99.5%, RSD<0.5% ( <i>n</i>=3). This method can easily and accurately determine the acetate content in hemodialysis solutions and dialysis concentrates, and can be applied to quality control in the production and use of such products.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"350-354"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509382","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 and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products]. [典型类Ⅱ伤口敷料产品全生命周期监管的研究与探讨]。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240550
Lan Zhang, Ye Zeng, Xin Xie, Jiaohui Bao, Xiaohe Yang, Weiming Qi
{"title":"[Research and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products].","authors":"Lan Zhang, Ye Zeng, Xin Xie, Jiaohui Bao, Xiaohe Yang, Weiming Qi","doi":"10.12455/j.issn.1671-7104.240550","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240550","url":null,"abstract":"<p><p>In this study, the pre-market regulatory requirements for typical Class Ⅱ wound dressings, as well as the status of testing and post-market adverse events monitoring, were reviewed from the perspective of the whole lifecycle of medical devices. Additionally, the regulatory requirements for wound dressings in China, the United States, and the European Union were compared. Supplementary research was also conducted on Class Ⅰ and Ⅱ liquid and paste dressing products. Furthermore, this study analyzed the issues in the registration and application of typical Class Ⅱ wound dressings and provided regulatory recommendations, aiming to offer technical references for the review and approval, inspection and testing, and post-market supervision of wound dressing products.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"344-349"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509387","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 of Leachable Substances in Prefilled Syringes]. [预充式注射器中可浸出物质综述]。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240353
Shuhan Wang, Senju Ma, Jun Peng, Linnan Ke, Yuanli Huang
{"title":"[Review of Leachable Substances in Prefilled Syringes].","authors":"Shuhan Wang, Senju Ma, Jun Peng, Linnan Ke, Yuanli Huang","doi":"10.12455/j.issn.1671-7104.240353","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240353","url":null,"abstract":"<p><p>As a new type of high-risk packaging container, prefilled syringes are more widely used, and concerns regarding their effectiveness, stability and safety in clinical use have become prominent increasingly. However, the leachable substances from prefilled syringes may cause harm to humans in different degrees. Therefore, this paper reviews the research progress of leachable substances in prefilled syringes, which is not only of great significance for the quality control of prefilled syringe products, but also contributes to the healthy development of the industry.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"280-286"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509392","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 Application of Intelligent Operation and Maintenance Models in Medical Equipment Management]. [智能运维模型在医疗设备管理中的应用研究进展]。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240561
Jin Li, Xiu Xu, Jing Tong, Wei Jin, Chenge Wang, Ruiyao Jiang
{"title":"[Research Progress on Application of Intelligent Operation and Maintenance Models in Medical Equipment Management].","authors":"Jin Li, Xiu Xu, Jing Tong, Wei Jin, Chenge Wang, Ruiyao Jiang","doi":"10.12455/j.issn.1671-7104.240561","DOIUrl":"10.12455/j.issn.1671-7104.240561","url":null,"abstract":"<p><p>Medical equipment management plays a crucial role in enhancing the quality and efficiency of healthcare services. However, traditional management approaches are increasingly inadequate to meet the growing demands of modern healthcare. As intelligent operation and maintenance (O&M) models based on big data, the Internet of Things (IoT), and artificial intelligence (AI) technologies develop, it is imperative to explore their application in medical equipment management. This paper reviews the technical overview of intelligent O&M and discusses the algorithms and challenges of intelligent O&M models based on different technologies. It also proposes issues that need improvement in intelligent O&M models, aiming to provide valuable references for the future development of medical equipment management.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"250-254"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509391","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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