中国医疗器械杂志最新文献

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[Performance Evaluation Methods and Suggestions for High-Voltage Generator and Tube of DR System]. [DR系统高压发电机及管的性能评价方法及建议]。
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.240066
Hairong Zou
{"title":"[Performance Evaluation Methods and Suggestions for High-Voltage Generator and Tube of DR System].","authors":"Hairong Zou","doi":"10.12455/j.issn.1671-7104.240066","DOIUrl":"10.12455/j.issn.1671-7104.240066","url":null,"abstract":"<p><p>In the design of DR systems, high-voltage generators and X-ray tubes are two key components whose performance directly affects the system's exposure capabilities. This article first explains why it is necessary to conduct an in-depth evaluation of the performance of these two parts during the design of DR products. Then, it provides a detailed description of the evaluation methods, including the assessment of single exposure capability and continuous exposure capability. Finally, the article offers some suggestions and measures to enhance continuous exposure capability. These methods and suggestions not only help in selecting appropriate key components but also provide an important reference for the design, integration, and testing of DR systems.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"613-617"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787753","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
[In Vitro Hydrodynamic Performance Evaluation of Valve Repair System]. [阀门修复系统的体外水动力性能评价]。
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.240172
Liang Cai, Yibin Li, Shiwen Lyu
{"title":"[<i>In Vitro</i> Hydrodynamic Performance Evaluation of Valve Repair System].","authors":"Liang Cai, Yibin Li, Shiwen Lyu","doi":"10.12455/j.issn.1671-7104.240172","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240172","url":null,"abstract":"<p><strong>Objective: </strong>To meet the treatment requirements for mitral regurgitation disease, this study designed a novel valve repair system and evaluated its hydrodynamic performance.</p><p><strong>Methods: </strong>A mitral regurgitation model was created. The valve repair system was loaded onto the regurgitation model, and pulsatile flow tests and steady backflow leakage tests were conducted.</p><p><strong>Results: </strong>The pulsatile flow test results indicated that the percentage of reflux after product implantation was lower than that before implantation under different concentric outputs and reverse pressures. The average cross-valve pressure difference after implantation was less than 5 mmHg. The steady backflow leakage test results showed that as the reverse pressure increased, the leakage amount of the valve repair system after implantation also increased.</p><p><strong>Conclusion: </strong>The developed valve repair system exhibits excellent hydrodynamic performance, suggesting the feasibility of its application in the treatment of clinical mitral regurgitation.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"603-606"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787593","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 Application and Clinical Evaluation Concerns of Embolization Microspheres]. 【栓塞微球的临床应用及临床评价问题】。
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.240205
Jing Liu, Jiaying Guo
{"title":"[Clinical Application and Clinical Evaluation Concerns of Embolization Microspheres].","authors":"Jing Liu, Jiaying Guo","doi":"10.12455/j.issn.1671-7104.240205","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240205","url":null,"abstract":"<p><p>Embolization microspheres can be used for the embolization of hypervascular malignant tumors of parenchymal organs. They can also be used as an adjuvant therapy for surgery to reduce perioperative bleeding through preoperative intravascular embolization of tumors. This study summarizes the clinical guidelines and consensus on embolization microspheres and introduces the guidance document for embolization microspheres issued by the Food and Drug Administration (FDA). Additionally, this study presents the authors' thoughts on clinical review of embolization microspheres, aiming to provide insights for the clinical evaluation and technical review of such products.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"694-698"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787694","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
[Intestinal Polyp Segmentation Based on Histogram Equalization ResNet (PE-ResNet)]. 基于直方图均衡化ResNet (PE-ResNet)的肠息肉分割[j]。
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.240235
Yukun An, Biao Zhang, Ming Yang, Qiyong Lin, Ping Zhou
{"title":"[Intestinal Polyp Segmentation Based on Histogram Equalization ResNet (PE-ResNet)].","authors":"Yukun An, Biao Zhang, Ming Yang, Qiyong Lin, Ping Zhou","doi":"10.12455/j.issn.1671-7104.240235","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240235","url":null,"abstract":"<p><p>Colonoscopy is an important technical means for screening early colorectal cancer lesions. Accurate segmentation of intestinal polyps helps improve the accuracy of screening. Early screening for lesions is of great significance for the prevention of colorectal cancer, and the segmentation of intestinal polyps is an important research direction. Although intestinal polyp segmentation based on deep learning has achieved acceptable performance, the color variation among intestinal endoscopic images significantly affects it. Based on the ResNet architecture, this study proposes an advanced PE-ResNet in which histogram equalization is used to reduce color influence. Experimental results on five datasets, including ClinicDB, demonstrate that the PE-ResNet model achieves improved performance in intestinal polyp segmentation.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"607-612"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787751","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
[Treatment Couch Path Planning for Proton Therapy Systems]. [质子治疗系统的治疗通道规划]。
中国医疗器械杂志 Pub Date : 2024-11-30 DOI: 10.12455/j.issn.1671-7104.240122
Rong Xie, Jianchun Deng, Hai Ma, Zhiyong Yang
{"title":"[Treatment Couch Path Planning for Proton Therapy Systems].","authors":"Rong Xie, Jianchun Deng, Hai Ma, Zhiyong Yang","doi":"10.12455/j.issn.1671-7104.240122","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240122","url":null,"abstract":"<p><p>In the treatment process of proton radiation therapy, the patient needs to be positioned and immobilized before being moved into the treatment position. In this study, the patient was primarily positioned using the 6R robotic treatment couch as the patient support system (PSS). A simplified three-dimensional model of the treatment room was developed based on the relative motion within the treatment room. The forward and inverse kinematics of the 6R robotic treatment couch were analyzed using an improved Denavit-Hartenberg (D-H) representation. A collision interference model was created based on the actual treatment process. The motion path of the treatment couch was planned and simulated in MATLAB using an improved artificial potential field method for obstacle avoidance. The results indicate that the robotic treatment couch can smoothly navigate around obstacles to reach the target point, satisfying the positioning requirements for proton therapy.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 6","pages":"595-602"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787764","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
[Design of a Conformal Ablation System Based on Independent Control of Radiofrequency Electrode Arrays]. [基于射频电极阵列独立控制的共形消融系统设计]。
中国医疗器械杂志 Pub Date : 2024-09-30 DOI: 10.12455/j.issn.1671-7104.240171
Jincheng Zou, Aili Zhang
{"title":"[Design of a Conformal Ablation System Based on Independent Control of Radiofrequency Electrode Arrays].","authors":"Jincheng Zou, Aili Zhang","doi":"10.12455/j.issn.1671-7104.240171","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240171","url":null,"abstract":"<p><p>This study aims to develop an independent control system for radiofrequency electrode arrays, intended for the conformal ablation of unwanted tissues. Unlike traditional single radiofrequency voltage applications, this study employs high-frequency transformer isolation and radiofrequency load matching technologies to divide the radiofrequency signal source into eight independent groups. Each group operates at the same phase and frequency but with different voltage values. Experimental results indicate that the designed system can independently output various combinations of radiofrequency signals. The actual output voltage has a relative error controlled within 6%, the frequency error is less than 0.5%, and the phase difference among the groups is less than 1°. In the biomimetic tissue heating experiments, it is found that by controlling the voltage of each electrode within the electrode array, ablation of different shapes can be achieved, and the ablation depth is positively correlated with the applied radiofrequency voltage.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 5","pages":"549-554"},"PeriodicalIF":0.0,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512745","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 Transcatheter Tricuspid Regurgitation Repair Device]. [经导管三尖瓣反流修复装置的研究进展]。
中国医疗器械杂志 Pub Date : 2024-09-30 DOI: 10.12455/j.issn.1671-7104.240097
Fengtao Hao, Yixin He
{"title":"[Research Progress of Transcatheter Tricuspid Regurgitation Repair Device].","authors":"Fengtao Hao, Yixin He","doi":"10.12455/j.issn.1671-7104.240097","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240097","url":null,"abstract":"<p><p>The tricuspid valve has been nicknamed the \"forgotten valve\" and is often neglected by clinicians. However, tricuspid regurgitation is a common clinical heart valve disease. With the continuous development of transcatheter interventional medical device technology, the treatment of tricuspid regurgitation has gradually attracted attention, and more and more companies are developing interventional medical devices for treating this disease. This review will provide an overview of the current research progress on transcatheter therapy for tricuspid regurgitation repair devices at home and abroad, including the design principles, operational steps, clinical outcomes, and the advantages and disadvantages of these devices.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 5","pages":"519-525"},"PeriodicalIF":0.0,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512781","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
[Bowel Sounds Detection Method Based on ResNet-BiLSTM and Attention Mechanism]. [基于 ResNet-BiLSTM 和注意力机制的肠鸣音检测方法]。
中国医疗器械杂志 Pub Date : 2024-09-30 DOI: 10.12455/j.issn.1671-7104.240043
Yali Hao, Xianrong Wan, Congqing Jiang, Xianghai Ren, Xiaoming Zhang, Xiang Zhai
{"title":"[Bowel Sounds Detection Method Based on ResNet-BiLSTM and Attention Mechanism].","authors":"Yali Hao, Xianrong Wan, Congqing Jiang, Xianghai Ren, Xiaoming Zhang, Xiang Zhai","doi":"10.12455/j.issn.1671-7104.240043","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240043","url":null,"abstract":"<p><p>Bowel sounds can reflect the movement and health status of the gastrointestinal tract. However, the traditional manual auscultation method has subjective deviation and is time-consuming and labor-intensive. In order to better assist doctors in diagnosing bowel sounds and improve the reliability and efficiency of bowel sound detection, this study proposed a deep neural network model that combines a residual neural network (ResNet), a bidirectional long short-term memory network (BiLSTM), and an attention mechanism. Firstly, a large number of labeled clinical data was collected using the self-developed multi-channel bowel sound acquisition system, and the multi-scale wavelet decomposition and reconstruction method was used to preprocess the bowel sounds. Then, log Mel spectrogram features were extracted and sent to the network for training. Finally, the performance and effectiveness of the model were evaluated and verified by 10-fold cross-validation and an ablation experiment. The experimental results showed that the precision, recall, and <i>F</i> <sub>1</sub> score of the model reached 83%, 76%, and 79%, respectively, and it could effectively detect bowel sound segments and locate their start and end times, performing better than previous algorithms. This algorithm can not only provide auxiliary information for doctors in clinical practice but also offer technical support for further analysis and research of bowel sounds.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 5","pages":"498-504"},"PeriodicalIF":0.0,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512728","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 on Progress of Intracranial Aneurysm Interventional Therapy Instruments]. [颅内动脉瘤介入治疗仪器进展讨论]。
中国医疗器械杂志 Pub Date : 2024-09-30 DOI: 10.12455/j.issn.1671-7104.230326
Han Zhang, Ping Liu, Qinglong Liu
{"title":"[Discussion on Progress of Intracranial Aneurysm Interventional Therapy Instruments].","authors":"Han Zhang, Ping Liu, Qinglong Liu","doi":"10.12455/j.issn.1671-7104.230326","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230326","url":null,"abstract":"<p><p>Intracranial aneurysm is a common cerebrovascular disease with high morbidity and mortality. Endovascular interventional therapy has advantages of high efficiency and minimally invasive. In this paper, the technical development of intracranial aneurysm interventional therapy Instruments was introduced, by interpreting the design mechanism of various types of coil, comparing the clinical benefits of braided and cut stents for assisting coil deployment, as well as analyzing the design principle and the optimization direction of currently the most eye-catching flow diverter, and thus the development and application of various interventional devices were discussed.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 5","pages":"512-518"},"PeriodicalIF":0.0,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512748","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
[Magnetically Induced Displacement Force Test Method for Ultralight Implants Based on Counterweight Correction Method]. [基于配重校正法的超轻植入体磁感应位移力测试方法]。
中国医疗器械杂志 Pub Date : 2024-09-30 DOI: 10.12455/j.issn.1671-7104.230711
Yong Yin, Jin Deng, Xiaomei Wu
{"title":"[Magnetically Induced Displacement Force Test Method for Ultralight Implants Based on Counterweight Correction Method].","authors":"Yong Yin, Jin Deng, Xiaomei Wu","doi":"10.12455/j.issn.1671-7104.230711","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230711","url":null,"abstract":"<p><p>ASTM (American Society for Testing and Materials) F2052-21 (Chinese corresponding standard titled as YY/T 0987.2) introduces a test method to measure the magnetically induced displacement force on medical devices in the magnetic resonance environment. This method has been widely accepted and utilized globally, which is intended for implantable medical devices that can be suspended from a string. The angular deflection of the string from the vertical is measured and thereby measuring out the magnitude of the magnetically induced deflection force relative to gravity. When applying this method on ultralight implants, it is practically almost impossible to use a suspension string that weighs less than 1% of the mass of the implant. That study proposes a method for measuring the magnetically induced displacement force on ultralight implants based on counterweight correction by using a string and clamp that exceed 1% of the weight of the implant. And then to measure the deflection angle according to the standard requirement, following that to correct the deflection angle by using the proportion of the mass of the implant under test to the total mass of the tested object, to obtain the measurement result. That study also provides theoretical calculations and experimental verification to the counterweight correction method, the results prove that the proposed method can effectively measure the magnetically induced displacement force on ultralight implants.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 5","pages":"473-477"},"PeriodicalIF":0.0,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512751","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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