中国医疗器械杂志最新文献

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[Design and Testing of a Pressure Measurement and Adjustment Device for Fracture Ends]. [断端压力测量和调整装置的设计与测试]。
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230484
Zhongyuan Shen, Yizhe Fan, Xiao Zhang, Zhen Han, Chengjian Wei
{"title":"[Design and Testing of a Pressure Measurement and Adjustment Device for Fracture Ends].","authors":"Zhongyuan Shen, Yizhe Fan, Xiao Zhang, Zhen Han, Chengjian Wei","doi":"10.12455/j.issn.1671-7104.230484","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230484","url":null,"abstract":"<p><strong>Objective: </strong>To design and test a device which is capable of accurately measuring and dynamically adjusting the axial pressure at the fracture end in real-time.</p><p><strong>Methods: </strong>Upon completion of the design, the pressure measurement and adjustment device was implemented in a canine tibial fracture external fixation model. A pressure sensor was mounted at the fracture end, and the displayed values of the pressure sensor were used as the standard for comparison. The relationship between the displayed values of the measurement and adjustment device and the pressure sensor under identical conditions was examined.</p><p><strong>Results: </strong>The device was utilized in external fixation models of tibial fractures in five beagles. A linear correlation was observed between the displayed values of the device and the pressure sensor at the fracture end. The measurement values from the device could be transformed into fracture end pressure through the application of coefficients, thereby facilitating accurate measurement and dynamic adjustment of the fracture end pressure.</p><p><strong>Conclusion: </strong>The pressure measurement and adjustment device at the fracture end is easy to operate, enabling precise measurement and dynamic regulation of the pressure at the fracture end. It is well-suited for animal experiments aimed at investigating the impact of axial compression on fracture healing, demonstrating promising potential for experimental applications.</p>","PeriodicalId":52535,"journal":{"name":"Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation","volume":"48 3","pages":"335-338"},"PeriodicalIF":0.0,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141307369","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
[Printing Process Quality Control of Bioprinting Medical Devices]. [生物打印医疗器械的打印过程质量控制]。
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230394
Neng Xie, Qixin Cao, Jinwu Wang, Yuanjing Xu, Changru Zhang, Ya Wang, Zitong Wang
{"title":"[Printing Process Quality Control of Bioprinting Medical Devices].","authors":"Neng Xie, Qixin Cao, Jinwu Wang, Yuanjing Xu, Changru Zhang, Ya Wang, Zitong Wang","doi":"10.12455/j.issn.1671-7104.230394","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230394","url":null,"abstract":"<p><strong>Objective: </strong>This study analyzes the risk points in the quality control of bioink and the main processes of bioprinting, clarifies and explores the quality control and supervision model for bioprinting medical devices, and provides theoretical and practical guidance to ensure the safety and effectiveness of bioprinting medical devices.</p><p><strong>Methods: </strong>The quality control risk points throughout the bioprinting process were comprehensively analyzed, with a particular focus on bioprinting materials and key processes. The regulatory model and methods for bioprinting medical devices were examined. This research concentrated on critical technologies such as extrusion, laser-assisted, and <i>in situ</i> bioprinting, assessing their potential for clinical applications and regulatory challenges.</p><p><strong>Results: </strong>Bioink from different sources should meet regulatory requirements. It is essential to ensure aseptic handling of raw materials and to validate sterilization under \"worst-case\" conditions.</p><p><strong>Conclusion: </strong>As bioprinting technology advances rapidly, corresponding research into materials, processes, and quality risk control should be conducted to ensure the concurrent development of the regulatory system. This will continuously contribute to the orderly progression of the entire industry and human health.</p>","PeriodicalId":52535,"journal":{"name":"Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation","volume":"48 3","pages":"245-250"},"PeriodicalIF":0.0,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141307374","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 Circulating Tumor Cell Detection System Based on Microfluidic Chip]. [基于微流控芯片的循环肿瘤细胞检测系统研究]。
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230595
Yuanshuai Di, Ji Luo, Dadi Gao, Haowen Yang
{"title":"[Study on Circulating Tumor Cell Detection System Based on Microfluidic Chip].","authors":"Yuanshuai Di, Ji Luo, Dadi Gao, Haowen Yang","doi":"10.12455/j.issn.1671-7104.230595","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230595","url":null,"abstract":"<p><strong>Objective: </strong>To achieve high throughput and high detection rate of circulating tumor cells (CTCs) in human peripheral blood, and to provide efficient and accurate early screening for cancer patients.</p><p><strong>Methods: </strong>A microfluidic chip with the integration of sorting, enrichment and detection was designed, and CTCs at the single cell level were detected by fluorescence detection system to obtain the number of CTCs in samples.</p><p><strong>Results: </strong>The peripheral blood samples after lysed red blood cells were used for 6 experiments. When the injection rate reached 0.2 mL/h, CTCs could reach the best detection rate of 78.6%, and the correlation coefficient within the group was above 0.8.</p><p><strong>Conclusion: </strong>CTCs detection system can achieve high detection rate and has good reliability, which can provide a reliable reference for clinical research in related fields.</p>","PeriodicalId":52535,"journal":{"name":"Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation","volume":"48 3","pages":"277-280"},"PeriodicalIF":0.0,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141307381","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 Field Inspection Issues and Some Suggestions for Software as Medical Device]. [现场检查问题分析及对软件即医疗器械的一些建议]。
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230639
Yiqiang Yang, Zhijin Fan, Shuting Guo
{"title":"[Analysis of Field Inspection Issues and Some Suggestions for Software as Medical Device].","authors":"Yiqiang Yang, Zhijin Fan, Shuting Guo","doi":"10.12455/j.issn.1671-7104.230639","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230639","url":null,"abstract":"<p><p>With the encouragement of policies and the rapid development of the biopharmaceutical industry, the number of software as medical device (SaMD) registration applications in Shanghai has continued to increase in recent years, and this paper summarizes the GMP nonconformities found in the field inspection of SaMD in Shanghai from 2020 to 2023, and the results show that nearly 70% of the problems were found in the software development process. Through in-depth analysis, this paper proposes the corresponding countermeasures for the problems found in the five most common stages such as software requirements, software design, software testing, software defect management and software configuration management, combined with the characteristics of software development. These suggested measures have certain reference significance for medical device software development and quality control personnel, and technical reviewer and inspectors.</p>","PeriodicalId":52535,"journal":{"name":"Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation","volume":"48 3","pages":"346-351"},"PeriodicalIF":0.0,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141307393","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
[Clinical Evaluation of Dural (Spinal) Membrane Repair Materials]. [硬膜(脊柱)膜修复材料的临床评估]。
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230638
Linling Zhang, Chang Su, Tingting Dong, Kun Zheng
{"title":"[Clinical Evaluation of Dural (Spinal) Membrane Repair Materials].","authors":"Linling Zhang, Chang Su, Tingting Dong, Kun Zheng","doi":"10.12455/j.issn.1671-7104.230638","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230638","url":null,"abstract":"<p><strong>Objective: </strong>To select high-quality and cost-effective dural (spinal) membrane repair materials, in order to reduce the cost of consumables procurement, save medical insurance funds, and optimize hospital operation and management.</p><p><strong>Methods: </strong>Taking the BS06B disease group (spinal cord and spinal canal surgery without extremely severe or severe complications and comorbidities, mainly diagnosed as congenital tethered cord syndrome) as an example, a retrospective analysis was conducted on the relevant data of surgical treatment for congenital tethered cord syndrome conducted in our hospital from January 2021 to June 2023. Safety and efficacy indicators in clinical application (incidence of postoperative epidural hemorrhage, incidence of postoperative purulent cerebrospinal meningitis, incidence of cerebrospinal fluid leakage, surgical duration, and postoperative hospital stay) were compared.</p><p><strong>Results: </strong>There was no difference in safety and effectiveness between different brands of dura mater repair materials.</p><p><strong>Conclusion: </strong>For the repair of small incisions in dura mater surgery, high-quality and cost-effective dura mater repair materials can be selected to reduce hospital costs and control expenses for the disease group.</p>","PeriodicalId":52535,"journal":{"name":"Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation","volume":"48 3","pages":"312-314"},"PeriodicalIF":0.0,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141307397","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
[Negative Poisson's Ratio Material Structure Based on 3D Printing and Its Application in Medical Field]. [基于三维打印的负泊松比材料结构及其在医疗领域的应用]。
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230585
Chongmin Huang, Tianhai Huang, Yonghua Chu
{"title":"[Negative Poisson's Ratio Material Structure Based on 3D Printing and Its Application in Medical Field].","authors":"Chongmin Huang, Tianhai Huang, Yonghua Chu","doi":"10.12455/j.issn.1671-7104.230585","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230585","url":null,"abstract":"<p><p>First of all, the overall framework of 3D printing is briefly introduced, including the basic principles of the additive manufacturing process, the classification and summary of the seven processes. Secondly, the common negative Poisson's ratio structure is introduced. Compared with the conventional structure, the negative Poisson's ratio structure has stronger energy absorption capacity, better fracture resistance and better indentation resistance, which are its advantages in printing manufacturing. Finally, 3D printing, the application of negative Poisson's ratio structure and the combination of the two are introduced from the different perspective of medical field, for example, the application of cardiovascular stent, biomedical material structure preparation, and lumbar disc implants. This paper suggests that the structural design of negative Poisson's ratio in 3D printing guides the development of new application directions in the medical field. Negative Poisson's ratio materials have a wide range of applications, not only in the medical field but also in mechanical equipment, automotive manufacturing, aerospace, and other high-tech industries.</p>","PeriodicalId":52535,"journal":{"name":"Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation","volume":"48 3","pages":"264-270"},"PeriodicalIF":0.0,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141307373","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
[Proposal and Analysis of "Ternary" Model of Sensitization for Proton Therapy]. [质子疗法敏化 "三元 "模型的建议和分析]。
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230563
Xiaowa Wang, Xufei Wang, Ning Du, Lan Wang
{"title":"[Proposal and Analysis of \"Ternary\" Model of Sensitization for Proton Therapy].","authors":"Xiaowa Wang, Xufei Wang, Ning Du, Lan Wang","doi":"10.12455/j.issn.1671-7104.230563","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230563","url":null,"abstract":"<p><p>In order to improve the biological effect of proton therapy, the authors first propose a new method of boron-based proton-enhanced radiotherapy in a \" ternary \" radiotherapy mode, based on the existing sensitizing effect of proton radiotherapy: i.e, Boron-based mediators (<sup>11</sup>B and <sup>10</sup>B) induce the proton-hydrogen-boron fusion reaction of the low-energy protons arriving at the Bragg peak region of the tumor target area (p+<sup>11</sup>B→3α) and thermal neutron capture (<sup>10</sup>B+n→<sup>7</sup>Li<sup>3+</sup>(0.84 MeV)+<sup>4</sup>He<sup>2+</sup>(1.47 MeV)+<math><mrow><mtext>γ</mtext></mrow></math>(0.477 MeV)), which release low-energy α-particles with high LETs to enhance the biological effect of proton dose in the target area, thus improve the clinical effect of proton therapy. Then, the advantages and disadvantages of the \"ternary\" model were analyzed from the theoretical basis and current research status, and finally, the \"ternary\" model is summarized and prospected.</p>","PeriodicalId":52535,"journal":{"name":"Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation","volume":"48 3","pages":"271-276"},"PeriodicalIF":0.0,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141307375","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 on Locating Device for the Entry Point of Intramedullary Nail Based on Inertial Navigation]. [基于惯性导航的髓内钉进入点定位装置研究]。
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-03-30 DOI: 10.12455/j.issn.1671-7104.230432
Chu Guo, Bobin Mi, Junwen Wang, Jing Jiao, Shilei Wu, Tian Xia, Jingfeng Li, Guohui Liu, Mengxing Liu
{"title":"[Research on Locating Device for the Entry Point of Intramedullary Nail Based on Inertial Navigation].","authors":"Chu Guo, Bobin Mi, Junwen Wang, Jing Jiao, Shilei Wu, Tian Xia, Jingfeng Li, Guohui Liu, Mengxing Liu","doi":"10.12455/j.issn.1671-7104.230432","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230432","url":null,"abstract":"<p><strong>Objective: </strong>To introduce a locating device for the entry point of intramedullary nail based on the inertial navigation technology, which utilizes multi-dimensional angle information to assist in rapid and accurate positioning of the ideal direction of femoral anterograde intramedullary nails' entry point, and to verify its clinical value through clinical tests.</p><p><strong>Methods: </strong>After matching the locating module with the developing board, which are the two components of the locating device, they were placed on the skin surface of the proximal femur of the affected side. Anteroposterior fluoroscopy was performed. The developing angle corresponding to the ideal direction of entry point was selected based on the X-ray image, and then the yaw angle of the locating module was reset to zero. After resetting, the locating module was combined with the surgical instrument to guide the insertion angle of the guide wire. The ideal direction of entry point was accurately located based on the angle guidance. By setting up an experimental group and a control group for clinical surgical operations, the number of guide wire insertion times, surgical time, fluoroscopy frequency, and intraoperative blood loss with or without the locating device was recorded.</p><p><strong>Results: </strong>Compared to the control group, the experimental group showed significant improvement in the number of guide wire insertion times, surgical time, fluoroscopy frequency, and intraoperative blood loss, with a statistically significant difference (<i>P</i><0.01).</p><p><strong>Conclusion: </strong>The locating device can assist doctors in quickly locating the entry point of intramedullary nail, effectively reducing the fluoroscopy frequency and surgical time by improving the success rate of the guide wire insertion with one shot, improving surgical efficiency, and possessing certain clinical value.</p>","PeriodicalId":52535,"journal":{"name":"Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation","volume":"48 2","pages":"179-183"},"PeriodicalIF":0.0,"publicationDate":"2024-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140873639","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 Risk Analysis and Key Points for Field Inspection of Medical Electron Linear Accelerator]. [医用电子直线加速器生产风险分析及现场检查要点]。
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-03-30 DOI: 10.12455/j.issn.1671-7104.230405
Yiqiang Yang
{"title":"[Production Risk Analysis and Key Points for Field Inspection of Medical Electron Linear Accelerator].","authors":"Yiqiang Yang","doi":"10.12455/j.issn.1671-7104.230405","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230405","url":null,"abstract":"<p><p>The medical electron linear accelerator(LINAC) has the characteristics of complex system structure, many core components and high precision control requirements, which puts forward higher requirements for product quality control and regulation. This study puts forward the main points of field inspection through the analysis of the technical characteristics and production risk of LINAC, combined with the requirements of the good manufacturing practice of medical devices. It has certain reference significance for quality management personnel and field inspectors.</p>","PeriodicalId":52535,"journal":{"name":"Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation","volume":"48 2","pages":"212-216"},"PeriodicalIF":0.0,"publicationDate":"2024-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140872900","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 in Data Acquisition and Intelligent Sensing Methods for Lumbar Electromyographic Signals]. [腰椎肌电信号数据采集与智能传感方法研究进展]。
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-03-30 DOI: 10.12455/j.issn.1671-7104.240014
Jinghui Feng, Yu Yu, Jianing Xi
{"title":"[Research Progress in Data Acquisition and Intelligent Sensing Methods for Lumbar Electromyographic Signals].","authors":"Jinghui Feng, Yu Yu, Jianing Xi","doi":"10.12455/j.issn.1671-7104.240014","DOIUrl":"10.12455/j.issn.1671-7104.240014","url":null,"abstract":"<p><p>Population aging trend is taking place in our country, and low back pain is a symptom of neuromuscular diseases of concern in the elderly. Accurately analyzing the disease of low back pain is important for both timely intervention and rehabilitation of patients. As a kind of bioelectrical signal, the acquisition and analysis of lumbar electromyography (EMG) signal is an important direction for the study of low back pain. The study reviews the acquisition of lumbar EMG by different types of sensors, introduces the signal characteristics of needle electrodes, surface electromyography electrodes and array electrodes, describes the use of signal algorithms, points out that wireless sensors and the use of deep learning algorithms are the direction of development, and puts forward prospects for its further development.</p>","PeriodicalId":52535,"journal":{"name":"Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation","volume":"48 2","pages":"119-125"},"PeriodicalIF":0.0,"publicationDate":"2024-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140867514","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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