中国医疗器械杂志Pub Date : 2024-11-30DOI: 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}
中国医疗器械杂志Pub Date : 2024-11-30DOI: 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}
中国医疗器械杂志Pub Date : 2024-11-30DOI: 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}
中国医疗器械杂志Pub Date : 2024-09-30DOI: 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}
中国医疗器械杂志Pub Date : 2024-09-30DOI: 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}
{"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}
中国医疗器械杂志Pub Date : 2024-09-30DOI: 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}
中国医疗器械杂志Pub Date : 2024-09-30DOI: 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}
中国医疗器械杂志Pub Date : 2024-09-30DOI: 10.12455/j.issn.1671-7104.240046
Fei He, Weiming Wang
{"title":"[Research on Test Method of Active Medical Device Preset Service Life Evaluation].","authors":"Fei He, Weiming Wang","doi":"10.12455/j.issn.1671-7104.240046","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240046","url":null,"abstract":"<p><p>When applying for registration of an active medical device, it is necessary to submit research and verification data regarding the device's service life. This study primarily proposes how to verify and evaluate the preset service life of active medical devices through reliability testing. Initially, the definition of the product's service life is introduced. Subsequently, the determination of the test sample size, the type and magnitude of the test stress, the conventional test duration, the accelerated test duration, and the evaluation of the service life of the active medical device based on the test results are elucidated. Finally, an example of evaluating the service life of a non-invasive ventilator is provided for further illustration. This study offers a comprehensive closed-loop process for verifying and evaluating the preset service life of active medical devices using the test method, providing a scientific, reasonable, practical, and exhaustive test evaluation approach for enterprises and regulatory agencies. This has broad significance for universal dissemination and aids enterprises and testing institutions in conducting pertinent research and verification tasks.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 5","pages":"586-590"},"PeriodicalIF":0.0,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512780","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}
{"title":"[Discussion on Magnetic Resonance Compatibility of Implantable Brain-Computer Interface Devices].","authors":"Kaixiang Jin, Xun Liu, Sheng Hu, Yonghua Li, Yuetong Wu, Jiaxing Li, Chenghuai Mo","doi":"10.12455/j.issn.1671-7104.240232","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.240232","url":null,"abstract":"<p><p>Brain-computer interface (BCI) devices are crucial tools for neural stimulation and recording, offering broad prospects in the diagnosis and treatment of neurological disorders. Furthermore, magnetic resonance imaging (MRI) is an effective and non-invasive technique for capturing whole-brain signals, providing detailed information on brain structures and activation patterns. Integrating the neural stimulation/recording capabilities of BCI devices with the non-invasive detection function of MRI is considered highly significant for brain function analysis. However, this combination imposes specific requirements on the magnetic and electronic performance of neural interface devices. The interaction between BCI devices and MRI is initially explored. Subsequently, potential safety risks arising from their combination are summarized and organized. Starting from the source of these hazards, such as the metallic electrodes and wires of BCI devices, the issues are analyzed, and current research countermeasures are summarized. In conclusion, the regulatory oversight of BCI's magnetic resonance safety is briefly discussed, and suggestions for enhancing the magnetic resonance compatibility of related BCI devices are proposed.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"48 5","pages":"486-492"},"PeriodicalIF":0.0,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512747","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}