中国医疗器械杂志最新文献_第2页

[Progress and Challenges in the Application of RhCE Models for Eye Irritation Evaluation of Medical Devices]. [RhCE模型在医疗器械眼刺激评价中的应用进展与挑战]。

中国医疗器械杂志 Pub Date : 2026-09-30 DOI: 10.12455/j.issn.1671-7104.260107

Xian He, Xin Lu, Xianhua Chen, Kejia Xu

引用次数: 0

[Research Progress of Hydrogel in Stomatology]. [水凝胶在口腔医学中的研究进展]。

中国医疗器械杂志 Pub Date : 2026-09-30 DOI: 10.12455/j.issn.1671-7104.250718

Xiaoqing Yang, Yongfu Huang, Ziwei Liu, Jing Liu

引用次数: 0

[Flow Field Investigation of Prosthetic Heart Valves during In Vitro Durability Testing]. 人工心脏瓣膜体外耐久性试验的流场研究

中国医疗器械杂志 Pub Date : 2026-09-30 DOI: 10.12455/j.issn.1671-7104.250792

Kunneng Wu, Jian Guo, Wentao Yan

{"title":"[Flow Field Investigation of Prosthetic Heart Valves during In Vitro Durability Testing].","authors":"Kunneng Wu, Jian Guo, Wentao Yan","doi":"10.12455/j.issn.1671-7104.250792","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.250792","url":null,"abstract":"According to the GB/T 12279 series of standards, a flow field test platform for heart valve durability testing was established. A digital particle image velocimetry system was employed to analyze the flow field characteristics of accelerated wear testing (AWT), dynamic failure mode testing (DFM), and real-time wear testing (RWT). The results showed that in AWT, the jet flow in the valve outflow tract appeared as clustered structures. As the frequency increased (from 15 Hz to 20 Hz), the peak flow velocity, peak VSS, and peak RSS all decreased. DFM testing revealed that an increase in pressure gradient (100 mmHg, 140 mmHg, 180 mmHg) was positively correlated with peak flow velocity and peak RSS, while no clear trend was observed for peak VSS. The flow field observed in RWT was closer to physiological conditions, with the jet flow fully developed, showing significant differences from the flow fields in AWT and DFM. A single testing method cannot comprehensively reflect the complex mechanical environment faced by the valve after actual implantation. This study provides a hemodynamic basis for demonstrating the necessity of a comprehensive evaluation of valve durability through AWT, DFM, and RWT.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 5","pages":"481-486"},"PeriodicalIF":0.0,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149171883","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 Intraoperative Motion-Following Technology for a Novel Robot-Assisted Total Knee Arthroplasty System]. 新型机器人辅助全膝关节置换术中运动跟踪技术的研究

中国医疗器械杂志 Pub Date : 2026-09-30 DOI: 10.12455/j.issn.1671-7104.250661

Zihan Li, Huiwu Li, Zanjing Zhai, Keyu Kong, Dajiang Li, Hui Shao

{"title":"[Study on Intraoperative Motion-Following Technology for a Novel Robot-Assisted Total Knee Arthroplasty System].","authors":"Zihan Li, Huiwu Li, Zanjing Zhai, Keyu Kong, Dajiang Li, Hui Shao","doi":"10.12455/j.issn.1671-7104.250661","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.250661","url":null,"abstract":"At present, joint surgical robots for total knee arthroplasty (TKA) still face certain technical limitations during the bone resection process. The conventional approach of using lower-limb fixators to immobilize the extremity suffers from two major drawbacks: increased risk of osteotomy error and prolonged operative time. To address these shortcomings, this study introduces an innovative real-time tracking motion-following technology for orthopedic surgical robots. This approach enables the robotic arm to dynamically monitor and precisely follow subtle movements of osseous structures intraoperatively, thereby ensuring stability and accuracy of osteotomy. The system is designed to be compatible with multiple categories of end-effector tools, including cutting guides, cantilever saws, and milling devices, offering broad applicability. By integrating real-time motion-following control, the robotic platform achieves significant improvements in both flexibility and precision, laying a solid foundation for further optimization and widespread clinical adoption of joint surgical robots.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 5","pages":"473-480"},"PeriodicalIF":0.0,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149169069","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 Technical Evaluation Considerations for CT X-Ray Tube's Reliability]. [CT x射线管可靠性研究与技术评价考虑]。

中国医疗器械杂志 Pub Date : 2026-09-30 DOI: 10.12455/j.issn.1671-7104.250844

Ying Wang, Xijie Xia, Chen Zheng, Zhaojun Guo

引用次数: 0

[Research on Quality Control Testing Methods for Laparoscopic Surgical Robots]. 腹腔镜手术机器人质量控制检测方法研究

中国医疗器械杂志 Pub Date : 2026-09-30 DOI: 10.12455/j.issn.1671-7104.250886

Heqing Lu, Yuan Liao, Jiaxin Zheng, Hao Yan, Chenying Xu, Zhigang Zhu, Shuhan Li, Haowei Zhang

{"title":"[Research on Quality Control Testing Methods for Laparoscopic Surgical Robots].","authors":"Heqing Lu, Yuan Liao, Jiaxin Zheng, Hao Yan, Chenying Xu, Zhigang Zhu, Shuhan Li, Haowei Zhang","doi":"10.12455/j.issn.1671-7104.250886","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.250886","url":null,"abstract":"To address the lack of quality and safety evaluation criteria and the inconsistency of testing methods in the clinical application of laparoscopic surgical robots, this study developed a scientific and operable testing method system based on a four-dimensional framework of \"device appearance and function-electrical safety-image quality-robotic arm and surgical instruments\". By identifying risk points of 21 core indicators, such as leakage current and horizontal/vertical resolution, and referencing standards such as YY/T 1712-2021 to determine the testing principles, the testing tools, operation steps, and limit values for each indicator were clearly defined. Multi-center validation was conducted on seven devices of different brands in three institutions. The validation results showed that the operability of the testing methods across different devices exceeded 90%, and the qualification rate of indicators was over 77%, effectively identifying latent device quality deficiencies. This system addresses a critical gap in the applied quality evaluation of laparoscopic surgical robots, providing standardized tools for hospital acceptance, daily quality control, and health supervision, and promoting the industrialization of medical devices and the standardization of the industry.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 5","pages":"487-497"},"PeriodicalIF":0.0,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149166736","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 the Application of Optical Fiber Light Transmission Method in the Removal of Soft Tissue Foreign Bodies]. [光纤光传输法在软组织异物去除中的应用研究]。

中国医疗器械杂志 Pub Date : 2026-07-30 DOI: 10.12455/j.issn.1671-7104.250458

Shujiao Song, Guanghui Zhang, Jiadong Xu, Danqin Zheng

引用次数: 0

[Local Intelligent Characteristic Enhancement for Ultrasound Imaging]. [超声成像局部智能特征增强]。

中国医疗器械杂志 Pub Date : 2026-07-30 DOI: 10.12455/j.issn.1671-7104.250551

Chongchong Guo, Xitao Li, Lei Li

{"title":"[Local Intelligent Characteristic Enhancement for Ultrasound Imaging].","authors":"Chongchong Guo, Xitao Li, Lei Li","doi":"10.12455/j.issn.1671-7104.250551","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.250551","url":null,"abstract":"In the process of ultrasound imaging, optimizing the transmit sequence strategy, adaptive beamforming algorithms, and image post-processing can significantly improve spatial resolution and tissue contrast. However, the direct integration of these advanced techniques invariably escalates the consumption of computational resources, causing a significant performance degradation in real-time imaging. This creates a critical trade-off challenge between real-time performance and image quality in ultrasonic diagnosis. In order to solve this problem, in this study, we introduce an imaging method that selectively enhances regional image quality while preserving real-time capability. This method can comprehensively consider the needs of different imaging scenarios and design one or more signal processing links specifically in local areas, thereby achieving intelligent characteristic enhancement functions such as noise suppression and texture enhancement. The results of the phantom test show that the noise suppression function of HD Scope + has improved by an average of 59.05%, 0.63 dB, and 0.0207 in contrast ratio (CR), contrast-to-noise ratio (CNR), and generalized contrast-to-noise ratio (gCNR) indexes compared to those of conventional B-mode images. In addition, the texture enhancement function of the HD Scope + has increased the fullwidth at half-maximum (FWHM) index by a maximum of 77.12%. The diagnostic results of hemangioma and pancreatic cyst indicate that the HD Scope + can provide richer local image characteristics, which is helpful for improving the accuracy of ultrasound diagnosis.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 4","pages":"355-360"},"PeriodicalIF":0.0,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867600","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

[Metabolic Flexibility Evaluation Method Based on Dynamic Respiratory Quotient Characteristics]. [基于动态呼吸商特征的代谢柔韧性评价方法]。

中国医疗器械杂志 Pub Date : 2026-07-30 DOI: 10.12455/j.issn.1671-7104.250654

Zixiang Wei, Yanyan Chen, Lanlan Wang, Lijie Shao, Wei Fang, Youcai Wang, Hao Chen

{"title":"[Metabolic Flexibility Evaluation Method Based on Dynamic Respiratory Quotient Characteristics].","authors":"Zixiang Wei, Yanyan Chen, Lanlan Wang, Lijie Shao, Wei Fang, Youcai Wang, Hao Chen","doi":"10.12455/j.issn.1671-7104.250654","DOIUrl":"10.12455/j.issn.1671-7104.250654","url":null,"abstract":"To address the need for metabolic disorder assessment, an evaluation model of metabolic flexibility was developed based on the dynamic characteristics of the respiratory quotient (RQ). This study enrolled 56 participants from the First Affiliated Hospital of University of Science and Technology of China, including 20 participants in the metabolically flexible group and 36 participants in the metabolically inflexible group. Clinical data were collected. Indirect calorimetry was used to measure RQ values at five time points during an oral glucose tolerance test. Features derived from RQ were extracted. A staged feature selection process was conducted to identify the most relevant predictors. The synthetic minority over-sampling technique (SMOTE) was applied to alleviate class imbalance. Evaluation models were established using logistic regression (LR), K-nearest neighbors (KNN), XGBoost, and random forest (RF) algorithms. All models demonstrated strong performance, with comprehensive scores exceeding 0.920. The RF model achieved the best performance, with an accuracy of 0.941, an F1-score of 0.957, an AUC of 0.985, and a comprehensive score of 0.961. The proposed method combines high predictive accuracy with physiological interpretability, providing a reliable basis for early screening of metabolic disease risk.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 4","pages":"361-366"},"PeriodicalIF":0.0,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867705","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 Status and Prospects of Intelligent Acupuncture Equipment]. [智能针灸设备研究现状与展望]。

中国医疗器械杂志 Pub Date : 2026-07-30 DOI: 10.12455/j.issn.1671-7104.250528

Yanan Zhao, Dan Zhao, Peijing Rong

{"title":"[Research Status and Prospects of Intelligent Acupuncture Equipment].","authors":"Yanan Zhao, Dan Zhao, Peijing Rong","doi":"10.12455/j.issn.1671-7104.250528","DOIUrl":"10.12455/j.issn.1671-7104.250528","url":null,"abstract":"Acupuncture, a traditional Chinese medical therapy, is undergoing a progressive intelligent transformation driven by modern technology. The integration of contemporary technology with traditional acupuncture has resulted in the evolution of smart acupuncture equipment. This evolution has transformed acupuncture from a diagnostic and therapeutic tool into an intelligent system encompassing a wide range of applications, including precision diagnosis, treatment and health management. This paper presents a systematic review of core technological advancements in smart acupuncture equipment, including perception and positioning, decision-making and intelligent algorithms, and execution and control. Furthermore, it delineates the contemporary state of research and development for innovative equipment such as smart acupuncture robots and intelligent acupuncture treatment units. Concurrently, it analyzes challenges constraining development, such as multidisciplinary talent shortages, incomplete industry standards, low research-to-practice conversion rates, and data security concerns. A number of strategies are proposed for advancing further development, including medical-engineering integration, standardisation initiatives, translational medical research, and data governance.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 4","pages":"400-406"},"PeriodicalIF":0.0,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867706","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