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MR Safe Robot, FDA Clearance, Safety and Feasibility of Prostate Biopsy Clinical Trial

机译:MR Safe Robot,FDA批准,前列腺活检临床试验的安全性和可行性

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Compatibility of mechatronic devices with the MR environment has been a very challenging engineering task. After over a decade of developments, we report the successful translation to clinical trials of our MR safe robot technology. MrBot is a six degree of freedom, pneumatically actuated robot for transperineal prostate percutaneous access, built exclusively of electrically nonconductive and nonmagnetic materials. Its extensive preclinical tests have been previously reported. Here, we present the latest technology developments, an overview of the regulatory protocols, and technically related results of the clinical trial. The Food and Drug Administration (FDA) has approved the MrBot for the biopsy trial, which was successfully performed in five patients. With no trajectory corrections and no unsuccessful attempts to target a site, the robot achieved an MRI-based needle targeting accuracy of 2.55 mm. To the best of our knowledge, this is the first robot approved by the FDA for the MR environment. The results confirm that it is possible to perform safe and accurate robotic manipulation in the MRI scanner, and the development of MR safe robots is no longer a daunting technical challenge.
机译:机电设备与MR环境的兼容性一直是一项非常具有挑战性的工程任务。经过十多年的发展,我们将MR安全机器人技术成功地翻译成临床试验。 MrBot是一款六自由度的气动机器人,用于经会阴前列腺经皮入路,完全由非导电和非磁性材料制成。先前已经报道了其广泛的临床前测试。在这里,我们介绍了最新的技术发展,监管协议的概述以及临床试验的技术相关结果。美国食品药品监督管理局(FDA)已批准MrBot进行活检试验,该试验已在5位患者中成功进行。由于没有进行轨迹校正,也没有尝试将目标瞄准失败,因此该机器人实现了基于MRI的2.55 mm针头瞄准精度。据我们所知,这是FDA批准的首个用于MR环境的机器人。结果证实,可以在MRI扫描仪中执行安全,准确的机器人操作,而MR安全机器人的开发不再是艰巨的技术挑战。

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