中国医疗器械杂志最新文献

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[Sixteen-Channel Multimodal High-Precision Transcranial Electrical Stimulation System Development]. [16通道多模态高精度经颅电刺激系统的开发]。
中国医疗器械杂志 Pub Date : 2025-07-30 DOI: 10.12455/j.issn.1671-7104.240448
Yan Hang, Qi Yin, Lin Huang, Fuhao Kang, Yanan Liu, Jilun Ye, Xu Zhang
{"title":"[Sixteen-Channel Multimodal High-Precision Transcranial Electrical Stimulation System Development].","authors":"Yan Hang, Qi Yin, Lin Huang, Fuhao Kang, Yanan Liu, Jilun Ye, Xu Zhang","doi":"10.12455/j.issn.1671-7104.240448","DOIUrl":"10.12455/j.issn.1671-7104.240448","url":null,"abstract":"<p><p>This paper introduces a 16-channel multimodal high-precision transcranial electrical stimulation system specifically for non-invasive brain stimulation. This system added TMCS mixed four traditional stimulation modes with TACS, TDCS, TPCS and TRNS. By designing a compensated high-precision constant current source, the constant stimulation current with an accuracy of 0.03 mA in the range of ±2 mA and the stimulation frequency of 50~200 kHz with low frequency of 0~4 kHz (high frequency of 0.1 Hz) are realized. In TACS stimulation mode, there are five adjustable wave forms: triangular wave, sine wave, sawtooth wave, square wave and mixed wave. The system has dual closed-loop control overcurrent detection and simultaneous real-time electrode contact impedance detection. After relevant tests and verification, the system has good stimulation accuracy, high safety and reliability. Compared with the existing products at home and abroad, it features lower cost, richer stimulation mode and waveforms, demonstrating a certain market application value.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 4","pages":"435-443"},"PeriodicalIF":0.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145066284","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 Coupling Analysis of Continuous Physiological Signals]. [连续生理信号耦合分析研究进展]。
中国医疗器械杂志 Pub Date : 2025-07-30 DOI: 10.12455/j.issn.1671-7104.240744
Guojing Wang, Weidong Wang, Hongyun Liu
{"title":"[Research Progress on Coupling Analysis of Continuous Physiological Signals].","authors":"Guojing Wang, Weidong Wang, Hongyun Liu","doi":"10.12455/j.issn.1671-7104.240744","DOIUrl":"10.12455/j.issn.1671-7104.240744","url":null,"abstract":"<p><p>The coupling analysis of continuous physiological signals is a crucial tool for revealing the dynamic activities and interactions within physiological systems. To gain a deeper understanding of the coupling relationships between physiological systems, this paper provides a comprehensive review of recent research on coupling analysis methods for continuous physiological signals, both domestically and internationally. It focuses on various coupling analysis techniques, including time-domain, frequency-domain, time-frequency-domain and nonlinear methods, and explores their applications in the coupling assessment of different physiological systems. Finally, the paper discusses the limitations of these methods and their future development trends. By systematically reviewing the current methods of continuous physiological signal coupling analysis, this paper aims to provide valuable references for further research on coupling evaluation methods for physiological systems.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 4","pages":"396-405"},"PeriodicalIF":0.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145066357","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 X-Ray Tube Technology for CT Systems:Key Component Innovation]. [CT系统x射线管技术进展:关键部件创新]。
中国医疗器械杂志 Pub Date : 2025-07-30 DOI: 10.12455/j.issn.1671-7104.240563
Haiyang Zhang, Zhiyong Ji, Ruiyao Jiang
{"title":"[Advances in X-Ray Tube Technology for CT Systems:Key Component Innovation].","authors":"Haiyang Zhang, Zhiyong Ji, Ruiyao Jiang","doi":"10.12455/j.issn.1671-7104.240563","DOIUrl":"10.12455/j.issn.1671-7104.240563","url":null,"abstract":"<p><p>In this paper, the technical basis and latest progress of X-ray tube for CT systems are introduced, with emphasis on material innovation, superconducting technology, liquid metal bearing, low dose scanning and electron beam filtration. As the core component of CT equipment, the technological innovation of CT X-ray tubes significantly improves image quality, reduces radiation dose, improves efficiency, and extends the service life of the X-ray tubes. Domestic and foreign manufacturers have made remarkable progress in the field of CT X-ray tubes. Domestic manufacturers, such as the 12th Institute of CLP, have made important progress in the development of CT X-ray tubes, and successfully achieved independent research and development of high-end CT X-ray tubes. Foreign manufacturers such as Siemens, GE, Philips and other manufacturers continue to innovate in liquid metal bearings, superconducting technology, new targets and other aspects to maintain technology leadership. In the future, CT X-ray tubes will develop in the direction of personalization, intelligence, long life, miniaturization and portability, providing more accurate and low-risk technical support for medical image diagnosis.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 4","pages":"383-388"},"PeriodicalIF":0.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145066189","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
[Thermal Structural Coupling Analysis of Gradient Coil Casting, Curing and Demolding Method]. [梯度卷板铸造、养护和脱模方法的热结构耦合分析]。
中国医疗器械杂志 Pub Date : 2025-07-30 DOI: 10.12455/j.issn.1671-7104.240598
Xiaotao Zhang, Zhanping Zheng, Yicheng Li
{"title":"[Thermal Structural Coupling Analysis of Gradient Coil Casting, Curing and Demolding Method].","authors":"Xiaotao Zhang, Zhanping Zheng, Yicheng Li","doi":"10.12455/j.issn.1671-7104.240598","DOIUrl":"10.12455/j.issn.1671-7104.240598","url":null,"abstract":"<p><p>The casting and curing of gradient coils in the production process is a relatively complex process. The chemical process similar to the black box model requires confirmation of the impact of each step of input on the output results, while the curing temperature and molding method affect the roundness and deformation of the gradient coils. The analysis of the curing temperature and demolding method of gradient coils has important practical significance for the formation and micro deformation of gradient coils. This article uses ANSYS finite element simulation software to analyze the thermal structural coupling and the specific performance of actual products. It has been found that the product quality is more stable under the heat conduction mode, and the roundness of the mold is better when placed vertically and waiting for temperature cooling before being demolding than when placed horizontally.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 4","pages":"363-368"},"PeriodicalIF":0.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145066311","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
[Production Research and Risk Factor Analysis of Transfusion and Infusion Warmer Based on Real-World Data]. [基于实际数据的输液器生产研究及风险因素分析]。
中国医疗器械杂志 Pub Date : 2025-07-30 DOI: 10.12455/j.issn.1671-7104.240688
Hongfeng Bi, Yonggang Wang, Zhendong Wang, Yuan Fu, Huifang Niu
{"title":"[Production Research and Risk Factor Analysis of Transfusion and Infusion Warmer Based on Real-World Data].","authors":"Hongfeng Bi, Yonggang Wang, Zhendong Wang, Yuan Fu, Huifang Niu","doi":"10.12455/j.issn.1671-7104.240688","DOIUrl":"10.12455/j.issn.1671-7104.240688","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the transfusion and infusion warmer manufacturers, combine the use failures to analyze adverse events, and provide support for enterprise risk management and clinical safe use.</p><p><strong>Methods: </strong>The sentinels from 7 manufacturing enterprises and 11 medical institutions that participated in Shandong Province's key monitoring program during the \"14th Five-Year Plan\" period were targeted. This was done by understanding the equipment's principles, structures, and quality control. Additionally, real-world data from January 2019 to December 2023 were collected to count adverse events.</p><p><strong>Results: </strong>During production, there are risks in switching power supply stability and solder joint firmness. Fifteen kinds of faults occurred during use, and common faults such as inability to heat, unable to turn on the machine, and bubbles in the infusion tube accounted for more than 80%.</p><p><strong>Conclusion: </strong>There are many risk points and failures for transfusion and infusion warmers, so enterprises should improve processes and quality control to address risks, and medical institutions should formulate specifications and maintenance plans to provide targeted theoretical basis for supervision.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 4","pages":"466-472"},"PeriodicalIF":0.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145066269","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
[Investigation on the Role of Medical Recombinant Human-Derived Collagen Functional Dressings in Wound Healing]. 医用重组人源性胶原蛋白功能敷料在伤口愈合中的作用研究
中国医疗器械杂志 Pub Date : 2025-07-30 DOI: 10.12455/j.issn.1671-7104.250072
Xiaoxiao Gai, Xiaoxia Sun, Wenqian Ma, Zhenhua Lin, Xinyuan Li, Chenghu Liu
{"title":"[Investigation on the Role of Medical Recombinant Human-Derived Collagen Functional Dressings in Wound Healing].","authors":"Xiaoxiao Gai, Xiaoxia Sun, Wenqian Ma, Zhenhua Lin, Xinyuan Li, Chenghu Liu","doi":"10.12455/j.issn.1671-7104.250072","DOIUrl":"10.12455/j.issn.1671-7104.250072","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the biological effect of medical recombinant human-derived collagen functional dressings in wound healing.</p><p><strong>Methods: </strong>MTT assay and RTCA assay were used to detect cell toxicity and proliferation. Scratch assay and Transwell cell migration assay were used to detect cell motility and migration ability. Enzyme-linked immunosorbent assay was used to detect the contents of vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and platelet-endothelial cell adhesion molecule (CD31) in the supernatant of four types of cells. After animal surgery, the surgical wound was taken at 1 week, 4 weeks and 13 weeks, respectively, for hematoxylin eosin (HE) staining and immunohistochemistry to observe the inflammatory response and CD31 expression of the wound.</p><p><strong>Results: </strong>Medical recombinant human-derived collagen functional dressing promotes cell proliferation and migration, enhances wound angiogenesis by upregulating the expression of VEGF, FGF, and CD31 in human dermal vascular endothelial cells (HDVEC) and human vascular endothelial cells (HVEC), thereby improving local blood supply to the wound, regulating the inflammatory response of the wound, and accelerating wound healing.</p><p><strong>Conclusion: </strong>Recombinant type Ⅲ humanized collagen plays an important role in wound healing.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 4","pages":"415-422"},"PeriodicalIF":0.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145066242","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 Design of Varian Accelerator Quality Management Monitoring System Based on Log Files]. 基于日志文件的瓦里安加速器质量管理监控系统的研究与设计
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240597
Jinhong Yao, Yan Jin, Xinyu Zhao
{"title":"[Research and Design of Varian Accelerator Quality Management Monitoring System Based on Log Files].","authors":"Jinhong Yao, Yan Jin, Xinyu Zhao","doi":"10.12455/j.issn.1671-7104.240597","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240597","url":null,"abstract":"<p><p>In order to track the running status of the accelerator in real time, discover potential problems in time, reduce the failure rate, and ensure the safety of radiotherapy patients, a linear accelerator quality management monitoring system is designed based on log files. The system adopts B/S architecture, with the server written in Python3.7 language, and is built based on Django2.2.7 framework. The system uses Python3.7 and Pylinac packages to analyze the log files of each plan, obtaining the planned beam quantity, flux gamma pass rate, and position information of multileaf collimator, etc., to realize the quality monitoring of medical linear accelerator, and customize the development of accelerator spare parts and maintenance management modules. According to statistics, after the establishment of the quality management monitoring system, the accelerator has achieved a 16% reduction in failure rate and a 30% reduction in the downtime rate, which ensures its stable operation in clinical settings.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"276-279"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509386","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 of External Ventricular Drainage Catheterization Techniques]. 外脑室引流置管技术的研究进展
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240460
Zhenzhen Han, Kunshan Yuan, Haijun Zhang
{"title":"[Research Progress of External Ventricular Drainage Catheterization Techniques].","authors":"Zhenzhen Han, Kunshan Yuan, Haijun Zhang","doi":"10.12455/j.issn.1671-7104.240460","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240460","url":null,"abstract":"<p><p>Insertion of external ventricular drainage (EVD) is an effective neurosurgical treatment approach. The accuracy of EVD insertion is related to potential complications, and the precise placement of the catheter tip can reduce the incidence of complications. With the progress of medical technology, the research and application of EVD catheterization technology are developing rapidly. This paper reviews the traditional blind catheterization, computed tomography, ultrasound guidance, mixed reality navigation system, laser positioning neural navigation, mobile device neural navigation, stereotactic system, and the visualization technology of the whole process of neuroendoscope assisted ventricle puncture to guide EVD catheterization to provide references for clinical decision-making by medical staff.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"287-294"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509390","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
[3D Pulse Image Detection and Pulse Pattern Recognition Based on Subtle Motion Magnification Technology]. 基于细微运动放大技术的三维脉冲图像检测与脉冲模式识别。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240567
Chongyang Yao, Yongxin Chou, Zhiwei Liang, Haiping Yang, Jicheng Liu, Dongmei Lin
{"title":"[3D Pulse Image Detection and Pulse Pattern Recognition Based on Subtle Motion Magnification Technology].","authors":"Chongyang Yao, Yongxin Chou, Zhiwei Liang, Haiping Yang, Jicheng Liu, Dongmei Lin","doi":"10.12455/j.issn.1671-7104.240567","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240567","url":null,"abstract":"<p><p>To address the problem of large reconstruction errors in 3D pulse signals caused by excessively small out-of-plane displacement of the contact membrane in the existing traditional Chinese medicine fingertip tactile binocular vision detection technology, this study proposes a 3D pulse image detection method based on subtle motion magnification technology and explores its application in pulse pattern recognition. Firstly, a 3D pulse image detection system based on binocular vision to obtain pulse image signals is developed as experimental data. Then, the phase motion video magnification algorithm is used to amplify the original signals, and the amplified signals are reconstructed in three dimensions to obtain 3D pulse signals. On this basis, nine features are extracted from the 3D pulse signals and features selection is performed using a two-sample Kolmogorov-Smirnov test. Finally, machine learning algorithms such as decision trees and random forests are used to identify the five types of pulse conditions: deep pulse, intermittent pulse, flooding pulse, slippery pulse, and rapid pulse. The experimental results show that compared to the methods without subtle motion magnification technology, the proposed method significantly improves waveform clarity, amplitude stability, and periodic regularity. Meanwhile, the average accuracy in pulse pattern recognition reaches 96.29%±0.26%.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"255-262"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509361","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
[Accuracy Assessment of Cone-Beam CT Images for Pelvic Tumor Dose Calculation]. 锥形束CT图像在骨盆肿瘤剂量计算中的准确性评估。
中国医疗器械杂志 Pub Date : 2025-05-30 DOI: 10.12455/j.issn.1671-7104.240655
Bao Li, Yongzhong Chen, Jun Jin, Longjun Yan, Xiaoyong Wang
{"title":"[Accuracy Assessment of Cone-Beam CT Images for Pelvic Tumor Dose Calculation].","authors":"Bao Li, Yongzhong Chen, Jun Jin, Longjun Yan, Xiaoyong Wang","doi":"10.12455/j.issn.1671-7104.240655","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240655","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the feasibility and accuracy of cone-beam CT (CBCT) images for radiotherapy dose calculation in pelvic tumors.</p><p><strong>Methods: </strong>An improved volumetric density coverage method was used to establish CT value-relative electron density (RED) curves for CBCT images. The planning CT plans were transferred to the CBCT images, and the constructed density curves were applied to calculate doses for CBCT plans while maintaining the optimization parameters unchanged. Dose calculation deviations between the two plans were analyzed.</p><p><strong>Results: </strong>The mean differences in dosimetric parameters for the target volume and organs at risk (OAR) between the two plans were less than 1% and 1.5%, respectively. The target conformity index (CI), homogeneity index (HI), and gamma passing rates were highly consistent, with no statistically significant differences.</p><p><strong>Conclusion: </strong>CBCT images corrected by this method can be used for dose calculation in pelvic tumor radiotherapy planning.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 3","pages":"302-307"},"PeriodicalIF":0.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509363","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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