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作 者:刘鹏波[1] 简小华[1] 韩志乐[1] 崔崤峣[1] 轩辕凯[2] LIU Peng-bo;JIAN Xiao-hua;HAN Zhi-le;CUI Xiao-yao;XUAN Yuan-kai(Medical Ultrasound Department, Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences,Suzhou 215163;State Food and Drug Administration Hubei Medical Device Quality Supervision and Inspection Center,Wuhan 430075)
机构地区:[1]中国科学院苏州生物医学工程技术研究所,苏州215163 [2]国家食品药品监督管理局湖北医疗器械质量监督检验中心,武汉430075
出 处:《中国医疗器械信息》2017年第9期6-8,共3页China Medical Device Information
基 金:国家重点研发计划(2016YFC0103300)项目
摘 要:随着体内高频超声成像技术的发展及设备的不断更新,其安全性与可靠性的研究日益重要。但目前国内尚未出台明确的检测标准,相关检测技术也未完善,尤其是在高频体内超声体模方面缺少合适的产品。文章用有机硅橡胶材料(RTV615)作基材并按照一定比例掺入粉末颗粒作为散射子制作了一种高频介入式超声体模,该体模具有与人体软组织相近似的高频声学性能,包括声速、声阻抗和声衰减系数。利用自制的高频(50MHz)血管内超声成像系统,对体模性能进行测试,与在体实验比较,二者测试结果相近似。同时,该高频超声体模在腔内超声成像如超声胃窥镜、支气管超声内镜等设备安全性、可靠性的研究应用中也能发挥重要的作用。With the development of high frequency ultrasound imaging technology and equipment in the body,the research on its safety and reliability is becoming moreand more important.But there is no corresponding domestic testing standards,the relevant detection technology is not perfect,especially in the high frequencybody ultrasound body model lack of appropriate products.Therefore,in order to compensate for the above shortcomings,this paper uses silicone rubbermaterial(RTV615)as the substrate,according to a certain proportion of powder particles as a scattering element made of a high-frequency interventionalultrasound model,with the human body soft tissue similar to the high Frequency acoustic performance,including sound velocity,acoustic impedance andacoustic attenuation coefficient.The self-made high-frequency(50MHz)intravascular ultrasound imaging system was used to test the body's performance.Thetest results were similar to those in the in vivo experiment.At the same time the high-frequency ultrasound body cavity in the cavity ultrasound imaging suchas ultrasound endoscopy,bronchial endoscopy and other equipment safety,reliability research and application can also play an important role.
分 类 号:R445.1[医药卫生—影像医学与核医学]
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