中国医疗器械杂志最新文献

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[Design and Implementation of Non-Invasive Hemodynamic Monitoring System Based on Impedance Cardiogram Method]. 基于阻抗心电图法的无创血流动力学监测系统的设计与实现
中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240364
Fuhao Kang, Qi Yin, Yanan Liu, Lin Huang, Yan Hang, Jilun Ye, Xu Zhang
{"title":"[Design and Implementation of Non-Invasive Hemodynamic Monitoring System Based on Impedance Cardiogram Method].","authors":"Fuhao Kang, Qi Yin, Yanan Liu, Lin Huang, Yan Hang, Jilun Ye, Xu Zhang","doi":"10.12455/j.issn.1671-7104.240364","DOIUrl":"10.12455/j.issn.1671-7104.240364","url":null,"abstract":"<p><p>Hemodynamic monitoring can reflect cardiac function and blood perfusion and is an indispensable monitoring method in clinical practice. Invasive hemodynamic monitoring methods represented by the thermodilution method are limited in their clinical application scope because they require vascular cannulation. Non-invasive hemodynamic monitoring has attracted extensive attention from medical companies and clinicians at home and abroad in recent years due to its advantages such as safety, non-invasiveness, continuous monitoring, simple operation, and low cost. This paper designs a non-invasive hemodynamic monitoring system based on the impedance cardiography, including hardware, algorithm, software design, and performance parameter evaluation. Among them, the hardware part mainly includes a differential high-frequency constant current source stimulation circuit, impedance cardiogram signal acquisition, and ECG signal acquisition circuit. Signal processing includes wave filtering, impedance cardiogram signal calibration, and ECG signal and impedance cardiogram signal feature point recognition. According to the collected impedance cardiogram and ECG signals, hemodynamic parameters such as heart rate (HR), stroke volume (SV), cardiac output (CO), stroke index (SI), cardiac index (CI), and cardiac contractility index (ICON) are calculated based on the Nyboer thoracic cylinder model. After testing, the key technical indicators of the system hardware are better than that of the relevant medical device standards. The system was used to collect impedance cardiogram and ECG signal data from 40 volunteers. The calculated HR, SV, and CO, three important hemodynamic indicators, were compared with the ICONCore non-invasive cardiac output monitor of OSYPKA Medical in Germany. Their Pearson correlation coefficients were 0.992 ( <i>P</i><0.001), 0.948 ( <i>P</i><0.001), and 0.933 ( <i>P</i><0.001), respectively, verifying that the designed system has high accuracy and reliability.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 1","pages":"80-88"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494766","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 Principle of Electrical Impedance Tomography and Its Application in Diagnosis and Treatment of Pulmonary Diseases]. 电阻抗断层成像原理及其在肺部疾病诊治中的应用研究进展
中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240361
Quchao Zou, Jinjiang Jin, Jianping Ye, Lijian Wang, Yiwen Wang, Tianhai Huang, Jucheng Zhang, Yonghua Chu
{"title":"[Advances in Principle of Electrical Impedance Tomography and Its Application in Diagnosis and Treatment of Pulmonary Diseases].","authors":"Quchao Zou, Jinjiang Jin, Jianping Ye, Lijian Wang, Yiwen Wang, Tianhai Huang, Jucheng Zhang, Yonghua Chu","doi":"10.12455/j.issn.1671-7104.240361","DOIUrl":"10.12455/j.issn.1671-7104.240361","url":null,"abstract":"<p><p>Electrical impedance tomography (EIT) is a technique that uses an array of electrodes to deliver safe stimulating currents and measures the boundary voltages between adjacent electrode pairs in the array in sequence. Subsequently, it reconstructs the impedance distribution in all or part of the tissue using reconstruction algorithms to achieve structural and functional imaging. Lung EIT technology features continuity, being radiation-free and non-invasive, and it can be used for real-time dynamic monitoring of the lungs in critically ill patients. This paper introduces the basic principles of lung EIT, analyzes the research progress and existing problems of the technology from the perspectives of hardware systems, imaging algorithms, and clinical applications (such as lung ventilation, lung perfusion, and lung function assessment), and discusses the development direction to provide ideas for expanding the clinical application of lung EIT.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 1","pages":"35-41"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494740","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 and Prospects of Minimally Invasive Surgical Instrument Segmentation Methods Based on Artificial Intelligence]. [基于人工智能的微创手术器械分割方法研究进展与展望]。
中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240436
Weimin Cheng, Xiaohua Wu, Jing Xiong
{"title":"[Research Progress and Prospects of Minimally Invasive Surgical Instrument Segmentation Methods Based on Artificial Intelligence].","authors":"Weimin Cheng, Xiaohua Wu, Jing Xiong","doi":"10.12455/j.issn.1671-7104.240436","DOIUrl":"10.12455/j.issn.1671-7104.240436","url":null,"abstract":"<p><p>With the development of artificial intelligence technology and the growing demand for minimally invasive surgery, the intelligentization of minimally invasive surgery has become a current research hotspot. Surgical instrument segmentation is a highly promising technology that can enhance the performance of minimally invasive endoscopic imaging systems, surgical video analysis systems, and other related systems. This article summarizes the semantic and instance segmentation methods of minimally invasive surgical instruments based on deep learning, deeply analyzes the supervision methods of training algorithms, network structure improvements, and attention mechanisms, and then discusses the methods based on the Segment Anything Model. Given that deep learning methods have extremely high requirements for data, current data augmentation methods have also been explored. Finally, a summary and outlook on instrument segmentation technology are provided.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 1","pages":"15-23"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494790","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
[Role of Establishment of Allowable Limits for Leachable Substances in Safety Evaluation of Medical Devices]. [建立可浸出物质容许限量在医疗器械安全评价中的作用]。
中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240016
Fangming Xu
{"title":"[Role of Establishment of Allowable Limits for Leachable Substances in Safety Evaluation of Medical Devices].","authors":"Fangming Xu","doi":"10.12455/j.issn.1671-7104.240016","DOIUrl":"10.12455/j.issn.1671-7104.240016","url":null,"abstract":"<p><p>The objective of inspection, testing and supervision of medical devices is to ensure the effectiveness and safety of medical devices in use. Leachables are substances that are leached from medical devices or materials during their clinical use. Leachables are important factors for the safety risks of medical devices. The analysis, detection, and safety evaluation of leachables are important parts of the safety evaluation of medical devices. The allowable limits for leachable substances which are established on the toxicological research provide a scientific basis for the judgment of qualitative and quantitative analysis results. Obtaining more detailed, rigorous and sufficient toxicological research data is of great significance to set highly enforceable product technical indicators. For the establishment of allowable limits for leachable substances, its role in the safety evaluation of medical devices is summarized, and the relevant standards and their implementation status in the testing of medical devices are introduced.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 1","pages":"103-110"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494792","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 Non-Invasive Continuous Blood Pressure Measurement System Based on Multiple Feature Parameters]. [基于多特征参数的无创连续血压测量系统的研制]。
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.230417
Mingyue Li, Zhiying Yuan, Ruowei Li, Jieying Shan, Jilun Ye, Xu Zhang, Hui Yu, Xiaoyu Wu
{"title":"[Development of Non-Invasive Continuous Blood Pressure Measurement System Based on Multiple Feature Parameters].","authors":"Mingyue Li, Zhiying Yuan, Ruowei Li, Jieying Shan, Jilun Ye, Xu Zhang, Hui Yu, Xiaoyu Wu","doi":"10.12455/j.issn.1671-7104.230417","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230417","url":null,"abstract":"<p><p>To address the issue of the difficulty in implementing non-invasive continuous blood pressure measurement technology in China, this study developed a high-performance synchronous electrocardiogram (ECG) and photoplethysmography (PPG) signal acquisition system. A PC-based human-computer interaction software platform was constructed, and continuous blood pressure measurement-related algorithms were integrated. Multiple feature parameters such as pulse wave transit time based on synchronous ECG and PPG signals were extracted, enabling non-invasive continuous blood pressure measurement. To verify the measurement accuracy of the system, tests and comparative verifications were carried out. The results demonstrated that the system could meet the requirements of relevant standards and have good application value.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"670-677"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787698","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
[Evaluation of Clinical Benefits of IoT Device Solutions in Operating Rooms]. 【手术室物联网设备解决方案临床效益评估】。
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.240105
Jing Zhang, Yang Liu, Qiangtian Chen, Jidong Zhang
{"title":"[Evaluation of Clinical Benefits of IoT Device Solutions in Operating Rooms].","authors":"Jing Zhang, Yang Liu, Qiangtian Chen, Jidong Zhang","doi":"10.12455/j.issn.1671-7104.240105","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240105","url":null,"abstract":"<p><strong>Objective: </strong>To explore device solutions for the Internet of Things (IoT) to enhance the efficiency of daytime operating rooms and process management in inpatient departments, and to address the issues of frequent and lengthy movements by anesthesiologists and circulating nurses. The study aims to evaluate the impact on surgical patients, determine the benefits of the proposed plan, reduce the duration of surgery for patients, and increase medical staff satisfaction.</p><p><strong>Methods: </strong>A comparative experiment was conducted between operating rooms with the implementation of IoT device solutions and those without. Quantitative data recorded were empirically analyzed using the <i>t</i> test.</p><p><strong>Results: </strong>The operating room utilizing the IoT solution experienced a reduction in the number and distance of movements by anesthesiologists and circulating nurses, as well as in the time required for surgical documentation, resulting in higher satisfaction levels.</p><p><strong>Conclusion: </strong>The use of the IoT plan in the operating room can improve operational efficiency, reduce documentation time, and enhance the work efficiency of anesthesiologists and circulating nurses through real-time data-driven decision-making.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"645-651"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787668","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
[Tooth Design of Ophthalmic Microsurgical Forceps Based on Minimum Slip Force]. 基于最小滑移力的眼科显微手术钳牙体设计
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.230715
Tianfeng Leng, Yu Zheng, Shaofeng Han, Chenhan Guang, Yang Yang
{"title":"[Tooth Design of Ophthalmic Microsurgical Forceps Based on Minimum Slip Force].","authors":"Tianfeng Leng, Yu Zheng, Shaofeng Han, Chenhan Guang, Yang Yang","doi":"10.12455/j.issn.1671-7104.230715","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230715","url":null,"abstract":"<p><p>This study proposed the use of the minimum slip force as an indicator to measure the clamping ability of microsurgical forceps. By analyzing the minimum slip forces of four typical tooth types of microsurgical forceps, the clamping capacity of each type was evaluated. Among the existing tooth forms, the staggered tooth type exhibited a relatively large minimum slip force. Consequently, a new tooth-shaped structure for microsurgical forceps - the hemispherical convex structure was proposed. Simulation and experimental studies demonstrated that this new dental structure could achieve stable and reliable clamping.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"678-682"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787761","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 about Testing Scheme of Intelligent Medical Devices]. 【智能医疗器械检测方案探讨】。
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.240163
Nan Zhang, Jing Li, Jie Zhang, Jiong Yang, Zhengbo Zhang, Kunlun He
{"title":"[Discussion about Testing Scheme of Intelligent Medical Devices].","authors":"Nan Zhang, Jing Li, Jie Zhang, Jiong Yang, Zhengbo Zhang, Kunlun He","doi":"10.12455/j.issn.1671-7104.240163","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240163","url":null,"abstract":"<p><p>Intelligent medical devices are flourishing with the deep integration of modern information and artificial intelligence technologies into healthcare. Testing is an important means of performance evaluation and quality control for intelligent medical devices. Compared with traditional medical devices, the testing methods and technologies of intelligent medical devices are still immature, and need active research to promote the progress in this area. Intelligent medical devices are classified according to their characteristics as artificial intelligence medical devices in the form of software and medical robots based on a general discussion of their development. The medical-device Internet of Things (IoT) system has also been included due to its close relation to the construction of smart hospitals. For each type of intelligent medical device, testing indexes and testing plans are discussed. It is suggested that specific test rules should be further developed for various specific devices. Besides, the evaluation method of complex intelligent systems should be introduced and real-world data should be used for evaluation. This paper aims to accelerate the development of intelligent medical device testing, laying the foundation for quality control and performance evaluation of intelligent medical devices.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"699-705"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787667","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
[Application of CT Radiomics in Predicting Differentiation Level of Lung Adenocarcinoma]. [CT放射组学在预测肺腺癌分化水平中的应用]。
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.240152
Shuai Zhang, Peng Han, Suya Zhang, Dingli Ye, Zhicheng Huang
{"title":"[Application of CT Radiomics in Predicting Differentiation Level of Lung Adenocarcinoma].","authors":"Shuai Zhang, Peng Han, Suya Zhang, Dingli Ye, Zhicheng Huang","doi":"10.12455/j.issn.1671-7104.240152","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240152","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the value of prediction of the differentiation level in lung adenocarcinoma based on CT radiomics model.</p><p><strong>Methods: </strong>Data from 507 patients with postoperative pathological confirmed lung adenocarcinoma and clearly defined differentiation level of lung adenocarcinoma were retrospective analyzed. The enrolled cases were divided into poorly differentiation group and moderate-to-high differentiation group based on the grading criteria. CT image features were extracted, and seven machine learning algorithms were used to construct prediction models to obtain the AUC, accuracy, specificity, and sensitivity.</p><p><strong>Results: </strong>The poorly differentiation group consisted of 175 cases, while the moderate-to-high differentiation group had 332 cases. The XGBoost model demonstrated the best performance, with the AUC, accuracy, specificity, and sensitivity of this model on the validation set being 0.878, 0.829, 0.667, and 0.727, respectively.</p><p><strong>Conclusion: </strong>CT radiomics model can effectively predict the differentiation level of poorly differentiation and moderate-to-high differentiation in lung adenocarcinoma.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"591-594"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787693","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 Evaluation of Encephalon State Index and Bispectral Index in Monitoring the Depth of Anesthesia during the Surgical Anesthesia Stage]. [手术麻醉阶段脑状态指数与双谱指数监测麻醉深度的比较评价]。
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.240143
Sanchao Liu, Nong Yan, Xingliang Jin, Xianliang He, Ke Xiao, Hanyuan Luo, Huacheng Luo, Yongjun Zeng, Jie Qin, Yinbing Yang, Yalan Li, Lan Gao
{"title":"[Comparative Evaluation of Encephalon State Index and Bispectral Index in Monitoring the Depth of Anesthesia during the Surgical Anesthesia Stage].","authors":"Sanchao Liu, Nong Yan, Xingliang Jin, Xianliang He, Ke Xiao, Hanyuan Luo, Huacheng Luo, Yongjun Zeng, Jie Qin, Yinbing Yang, Yalan Li, Lan Gao","doi":"10.12455/j.issn.1671-7104.240143","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240143","url":null,"abstract":"<p><strong>Objective: </strong>Evaluate the performance of the encephalon state index (ESI) in depth of anesthesia monitoring during clinical surgery, compared with the bispectral index (BIS).</p><p><strong>Methods: </strong>ESI and BIS data were collected from 60 patients in a single-center clinical trial to compare their efficacy in measuring the depth of anesthesia.</p><p><strong>Results: </strong>Consistency analysis revealed mean differences and standard deviations of -0.18 ± 5.42 and -0.11 ± 6.51 between ESI and BIS for awake and anesthetized states, respectively. Correlation analysis showed a correlation coefficient of 0.92 throughout the operative period. Prediction probability analysis indicated that both ESI and BIS had prediction probabilities of 0.97, effectively predicting anesthesia status.</p><p><strong>Conclusion: </strong>ESI and BIS show good equivalence in monitoring depth of anesthesia during clinical surgery, which meet the requirements of clinical anesthesia.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"639-644"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787695","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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