中国医疗器械杂志最新文献_第6页

[Current Situation and Development Trends Analysis of Innovative Medical Devices for Heart Valve Intervention]. 心脏瓣膜介入创新医疗器械现状及发展趋势分析

中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240326

Mingyang Li

引用次数: 0

[Torso Simulation Research on Electromagnetic Compatibility of Implantable Neurostimulator]. [植入式神经刺激器电磁兼容性的躯干仿真研究]。

中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.230726

Qifei Li, Weiming Wang, Weiqiang Zhang, Linzhi Dai, Jiawei Liu

引用次数: 0

[Analysis of the Influence of Different Scanning Conditions of Medical Linear Accelerator CBCT on Image Quality]. [医用直线加速器CBCT不同扫描条件对图像质量的影响分析]。

中国医疗器械杂志 Pub Date : 2025-03-30 DOI: 10.12455/j.issn.1671-7104.240480

Li Liu, Chengwei Ye, Jianjun Yuan, Yingui Luo, Zhiyao Luo, Wei Zeng, Ling Li, Huan Liu, Yan Liu

{"title":"[Analysis of the Influence of Different Scanning Conditions of Medical Linear Accelerator CBCT on Image Quality].","authors":"Li Liu, Chengwei Ye, Jianjun Yuan, Yingui Luo, Zhiyao Luo, Wei Zeng, Ling Li, Huan Liu, Yan Liu","doi":"10.12455/j.issn.1671-7104.240480","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240480","url":null,"abstract":"Objective: To investigate the influence of different scanning conditions on the image quality of medical electron accelerator cone-beam computed tomography (CBCT) and provide a reference for the selection of scanning conditions for different body parts. Methods Set different scanning conditions, the Catphan 503 phantom was scanned using CBCT parameters to analyze the influence of spatial resolution, noise, uniformity, spatial geometric accuracy, and low-contrast resolution on the image quality of CBCT.Results: For the head, chest, and abdomen, with the increase in scanning parameter values, the noise value decreased by 47.4%, 26.1%, and 51.3% respectively, and the uniformity values decreased by 30.2%, 26.6%, and 47.9% respectively. The low-contrast resolution values decreased by 50.6%, 34.2%, and 12.0%. The influence of different scanning conditions on spatial geometric accuracy and spatial resolution is not significant.Conclusion: Different scanning parameters have a certain influence on the image quality of medical electron accelerator CBCT. Lower scanning parameters can be selected based on individual patients to reduce the additional radiation dose, providing a reference for the safe application of CBCT image guidance in radiotherapy.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 2","pages":"176-180"},"PeriodicalIF":0.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143998978","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 Vibration Characteristics of Deep Brain Stimulator Induced by Magnetic Resonance Gradient Magnetic Field]. [磁共振梯度磁场诱导深部脑刺激器振动特性研究]。

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240229

Ya Chen, Peng Cao, Sheng Hu, Kai Zheng, Xun Liu

{"title":"[Study on Vibration Characteristics of Deep Brain Stimulator Induced by Magnetic Resonance Gradient Magnetic Field].","authors":"Ya Chen, Peng Cao, Sheng Hu, Kai Zheng, Xun Liu","doi":"10.12455/j.issn.1671-7104.240229","DOIUrl":"10.12455/j.issn.1671-7104.240229","url":null,"abstract":"The gradient coils of MRI equipment can induce vibrations in implantable medical devices, causing periodic vibrations of implantable medical devices with respect to the surrounding tissue. This not only results in instrument failure but also causes discomfort to the patient. Therefore, studying the vibration characteristics of implantable devices under different scanning sequences and the orientation of the device relative to the magnetic field is crucial for comprehending vibration performance. This study observed the vibration spectra of a full cranial bone-implanted neurostimulator by using laser vibrometry under typical rapid imaging sequences and explored the impact of different magnetic field orientations on vibration. The results demonstrated that the rapid echo sequences induced diverse and rich vibration components, whereas the planar echo sequences caused relatively simple vibrations. Additionally, the strongest vibrations normally occurred in the maximum conductive surface parallel to the phase-coded direction. It revealed the factors influencing the vibrations of skull fixation active implantable devices and provided guidance for enhancing device safety and protecting patient well-being during MR examinations.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 1","pages":"8-14"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494805","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 Brain-Computer Interface Technology in the Medical Field and the Regulation of the US FDA]. 【医疗领域脑机接口技术分析及美国FDA监管】。

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240187

Jiaying Guo, Jieying Yang, Yaohua Li

{"title":"[Analysis of Brain-Computer Interface Technology in the Medical Field and the Regulation of the US FDA].","authors":"Jiaying Guo, Jieying Yang, Yaohua Li","doi":"10.12455/j.issn.1671-7104.240187","DOIUrl":"10.12455/j.issn.1671-7104.240187","url":null,"abstract":"Brain-computer interface (BCI) technology is an innovative and cutting-edge medical advancement that enables direct interaction between the brain and external devices, facilitating the reconstruction of daily functions for patients or serving as a method for neuro-regulation therapy. Although this technology offers a broad range of clinical applications, there are problems as potential risks, individual variations, and the need for long-term monitoring of its effects during utilization. Consequently, the comprehensive evaluation of its safety and effectiveness poses a considerable challenge for regulatory agencies. This study provides a concise introduction to the development history and various types of BCI technology, followed by a summary of the regulatory situation for different types of BCI medical devices in the United States. Furthermore, the regulatory requirements imposed by the US FDA on this product category are analyzed. Finally, the article concludes by presenting a summary and future perspective on the current development of BCI technology, with the aim of offering beneficial insights and guidance for the regulation of BCI medical devices.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 1","pages":"96-102"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494743","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 Pre-Clinical In-Vitro Test Methods of Unicondylar Knee Prosthesis]. 单髁膝关节假体临床前体外测试方法研究

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240327

Shu Yang, Dan Han, Wen Cui, Zhenxian Chen, Jinju Ding, Jintao Gao, Bin Liu

引用次数: 0

[Design and Reliability Research of Spherical Radiotherapy Accelerator Motion System]. 球形放疗加速器运动系统设计与可靠性研究

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240288

Shuming Xu, Yongxin Che, Haipeng Liang, Guoyong Zhao, Yanjie Li

引用次数: 0

[Application Research of mDIXON-Quant Quantitative T2* Values and FF Values in Cervical Intervertebral Disc Degeneration]. [mdixon -定量T2*值和FF值在椎间盘退变中的应用研究]。

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240348

Peng Liu, Meichen Niu, Hong Liu

{"title":"[Application Research of mDIXON-Quant Quantitative T2* Values and FF Values in Cervical Intervertebral Disc Degeneration].","authors":"Peng Liu, Meichen Niu, Hong Liu","doi":"10.12455/j.issn.1671-7104.240348","DOIUrl":"10.12455/j.issn.1671-7104.240348","url":null,"abstract":"Objective: To investigate the clinical value of MRI modified water-lipid separation technique (mDIXON-Quant) in terms of T2* values and fat fraction (FF) values for evaluating the degree of cervical intervertebral disc degeneration.Methods: A total of 118 patients who underwent routine MRI of the cervical vertebra and the mDIXON-Quant examination in Fuyang People's Hospital from March 2019 to January 2024 were collected. The T2* values of C2/3 to C6/7 intervertebral discs and FF values of the upper and lower vertebral bodies were measured. Cervical intervertebral disc degeneration was graded according to the Pfirrmann criteria. The T2* values and FF values of different patients were compared with the Pfirrmann grades, and the correlation between T2* values, FF values, and Pfirrmann grades was analyzed by Spearman correlation.Results: The T2* values of cervical intervertebral discs in grades I, II, III, IV, and V all showed a decreasing trend ( P＜0.05). The decreasing order of FF values in the upper cervical vertebra was IV, V, III, II, and I ( F=93.28, P＜0.05), and the decreasing order of FF values in the lower cervical vertebra was IV, III, V, II, and I ( F=112.037, P＜0.05). Spearman correlation analysis showed that the T2* values of cervical intervertebral discs were negatively correlated with the Pfirrmann grades ( P＜0.05), and the FF values of the upper and lower vertebrae were positively correlated with the Pfirrmann grades ( P＜0.05).Conclusion: The mDIXON-Quant technique can be used to quantify the T2* values and FF values of cervical intervertebral disc degeneration and plays an important role in accurate clinical diagnosis and evaluation of treatment effects.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 1","pages":"61-66"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494751","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

[Comparative Research on Regulatory Requirements of Radiotherapy Equipment Across Countries]. 【各国放疗设备监管要求比较研究】。

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240302

Chao Sun, Yue Yu, Hong Fang, Jingting Du, Yu Tang

引用次数: 0

[Evaluation of Clinical Practicability of Hybrid Automatic Treatment Planning for Nasopharyngeal Carcinoma]. 鼻咽癌混合自动治疗方案临床实用性评价

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240159

Enwei Mo, Lei Yu, Jiyou Peng, Long Yang, Jiazhou Wang, Weigang Hu

{"title":"[Evaluation of Clinical Practicability of Hybrid Automatic Treatment Planning for Nasopharyngeal Carcinoma].","authors":"Enwei Mo, Lei Yu, Jiyou Peng, Long Yang, Jiazhou Wang, Weigang Hu","doi":"10.12455/j.issn.1671-7104.240159","DOIUrl":"10.12455/j.issn.1671-7104.240159","url":null,"abstract":"Objective: Automatic planning is a commonly used alternative to manual planning. This study evaluated the clinical performance of automatic plans available in commercial treatment planning systems for nasopharyngeal carcinoma (NPC) treatment by comparing automatic planning with manual planning.Methods: A total of 14 patients with nasopharyngeal carcinoma were enrolled in the study. For each patient, three different sets of clinical goals were used to generate three hybrid automatic plans based on 3D dose distribution prediction and three automatic plans based on script, respectively, which were compared with the manual plans used in clinic.Results: The dose coverage performance of the automatic planning based on 3D dose distribution prediction on the planning target volume (PTV) was comparable to that of the manual planning. Automatic planning based on 3D dose prediction achieved the level of manual planning in most organs at risk. However, automatic planning based on scripts did not perform well in the prediction of some organs at risk, especially the parotid gland.Conclusion: The hybrid automatic plan based on 3D dose distribution prediction can reach the level of manual planning and have good robustness with the change of clinical objective.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 1","pages":"55-60"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494786","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