NMPA：国产神外手术机器人家族添新丁

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                    <section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span><span></span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><br  /></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><span>根据NMPA公布的消息，近日NMPA经审查，批准了“神经外科手术导航定位系统”——NS1的注册。</span></p></section></section></section></section></section></section></section><section><br  /></section><section><span>该设备由红外摄像机（Polaris）、工作站（主机、显示器）、支架、定位组件（探针、参考架、连接器、反光球）、手术器械适配器（孔型、钳型2.5~8mm、钳型8~16mm）和手术导航软件组成。可用于神经外科手术的术前计划和术中定位引导。</span></section><section><br  /></section><p><p><img src="image/20201014/16f2cdaae4ad35c7bdd042788eabca6e_2.png" /></p></p><section><span>神经外科手术导航系统</span></section><section><br  /></section><section><span>这款产品出自研发我国首款可用于手术治疗癫痫、帕金森、颅内肿瘤、脑出血等疾病神经外科创新手术机器人的高端创新医疗器械研发生产企业——华科精准（北京）医疗科技有限公司。</span></section><section><br  /></section><p><br  /></p><p><br  /></p><p><p><img src="image/20201014/aa2aa8b9c367767906b31dbca3f5068c_3.jpg" /></p></p><p><span>华科精准神经外科手术机器人</span></p><section><br  /></section><section><span><strong><span>神经手术机器人的优势</span></strong></span><br  /></section><section><br  /></section><section><span>提起手术机器人，当属“达芬奇”最为闻名遐迩，但“达芬奇”主要针对泌尿外科、肠胃外科等侵入性手术，而神经外科手术机器人同样具有精准、创伤小等特点，主要应用于癫痫、帕金森症、脑出血、颅内肿瘤等神经外科手术领域，是临床治疗上对立体定向框架技术的全面替代和超越。</span></section><section><br  /></section><p><p><img src="image/20201014/27c4d5502b6b89f2560f9f0f60f35fd0_4.jpg" /></p></p><section><br  /></section><p><span>在神经内窥镜的手术中，医学机器人通过制定手术计划，配合神经内镜精准确定肿瘤切除大小和范围，帮助医生实现安全范围操作。机器人在术中可以提供导航和精细操作，误差仅达0.1毫米，移动的最小范围可达0.1毫米。相对于人手的晃动，机器人可以非常稳定地实现安全操作。因此，机器人大幅提升了手术中的安全性。</span></p><p><br  /></p><p><span><strong>国内<span>神经外科手术导航定位系统</span></strong></span></p><p><br  /></p><section><span>不算刚刚过审的NS1，NMPA仅审批通过了7款“神经外科手术导航定位系统”，其中3款为国内机构生产、研发。最后，我们来简单了解一下这三款国产定位系统。</span></section><section><br  /></section><table cellspacing="0" cellpadding="0" width="631"><tbody><tr><td><p><span><strong><span>注册人</span></strong></span></p></td><td><p><span><strong><span>注册证编号</span></strong></span></p></td><td valign="top"><p><span><strong><span>注册型号</span></strong></span></p></td><td valign="top"><p><span><strong><span>导航原理</span></strong></span></p></td></tr><tr><td><p><span>华科精准(北京)医疗科技有限公司</span></p></td><td><p><span>国械注准20183010598</span></p></td><td valign="top"><p><span>SR1</span></p></td><td valign="top"><p><span>光学</span></p></td></tr><tr><td><p><span>北京柏惠维康科技有限公司</span></p></td><td><p><span>国械注准20183540127</span></p></td><td valign="top"><p><span>RM-100(Remebot)</span></p></td><td valign="top"><p><span>光学</span></p></td></tr><tr><td><p><span>美敦力导航股份有限公司</span></p></td><td><p><span>国械注进20183010514 / 国械注进20173546129</span></p></td><td valign="top"><p><span>I7 &nbsp;(Cranial) / S8 Cranial</span></p></td><td valign="top"><p><span>光学</span></p></td></tr><tr><td><p><span>Fiagon &nbsp;GmbH</span></p></td><td><p><span>国械注进20163542672</span></p></td><td valign="top"><p><span>FiagonBRAIN</span></p></td><td valign="top"><p><span>电磁</span></p></td></tr><tr><td><p><span>史赛克莱宾格股份两合公司</span></p></td><td><p><span>国械注进20163700602</span></p></td><td valign="top"><p><span>NAV3</span></p></td><td valign="top"><p><span>光学</span></p></td></tr><tr><td><p><span>Compass &nbsp;International Inc.</span></p></td><td><p><span>国械注进20163540395</span></p></td><td valign="top"><p><span>Cygnus-PFS</span></p></td><td valign="top"><p><span>电磁</span></p></td></tr><tr><td><p><span>上海复旦数字医疗科技有限公司</span></p></td><td><p><span>国械注准20153540492</span></p></td><td valign="top"><p><span>excelim-04</span></p></td><td valign="top"><p><span>光学</span></p><p><br  /></p></td></tr></tbody></table><section><span>表格来源：智械猎新</span></section><section><span><br  /></span></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><br  /></section></section><section powered-by="gulangu"><section><br  /></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><p><span><strong><span>华科精准&nbsp;SR1</span></strong></span></p></section></section></section></section></section></section></section><section><br  /></section><section><span>由主机、机械臂、定位器、连接器、脚踏开关和立体定向规划系统软件组成。适用于5岁以上儿科患者及成人患者的神经外科立体定向手术的定位定向。术前计划由医生术前完成患者三维影像重建并制定手术计划。术中注册通过激光扫描患者面部特征，实现患者头部坐标系与三维影像坐标系的注册。术中引导由医生操作机械臂到达术前计划预定位置并锁止，实现手术器械的定位定向。</span></section><section><span><br  /></span></section><p><p><img src="image/20201014/52851ce9c89aac012f7dfde7382868b6_5.jpg" /></p></p><section><br  /></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><br  /></section></section><section powered-by="gulangu"><section><br  /></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><p><span><strong><span>柏惠维康RM-100(Remebot)</span></strong></span></p></section></section></section></section></section></section></section><section><br  /></section><section><span>北京柏惠维康科技有限公司成立于 2010 年，是一家专业从事医疗机器人研发、生产、销售、运营的高科技公司，目前已获得相关领域 8 项发明专利，十余项软件著作权和其他专利。“睿米”神经外科手术机器人（Remebot）是其主要产品。此前，柏惠维康已获雅瑞资本、真格基金、海泉基金、普华资本等机构近亿元投资。医生在神经外科手术机器人的帮助下实现微创、精准、高效的无框架立体定向手术,手术平均用时仅30分钟,定位精度达到1mm,患者只留下1个2mm以内的创口。</span></section><section><br  /></section><p><p><img src="image/20201014/98f256775d1f835661d8993192149d2a_6.png" /></p></p><section><br  /></section><section><br  /></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><br  /></section></section><section powered-by="gulangu"><section><br  /></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><p><span><strong><span><span>复旦数字excelim-04</span></span></strong></span></p><p><br  /></p></section></section></section></section></section></section></section><section><span><br  /></span></section><section><span>复旦大学数字医学研究中心是国内率先提出“数字医疗”概念的机构，excelim-04采用先进的图像重建、配准融合、定位跟踪、变形校正等技术，以CT、MRI等医学影像数据为基础，建立精确的人体三维模型，借助光学定位仪定位手术器械，跟踪显示手术器械和病灶的空间位置关系，对手术全程进行实时引导和监控。</span></section><section><br  /></section><section><p><img src="image/20201014/b02129a31078efc0df38015ab7e6161a_7.jpg" /></p></section><section><br  /></section><section><span>该系统可引导医生准确定位、界别与切除病变组织，减少对重要血管、神经等功能组织的损伤，提高手术精确性，降低手术风险。<br  /></span></section><section><span><br  /></span></section><section><span><span>资料来源：</span><span>智械猎新</span></span></section><section><span><br  /></span></section><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="paragraph"><section><section><section 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