AccuGyd: Accurate Guidance for MRI-Guided Minimally Invasive Neurosurgery

摘要：微创手术的好处每年扩展到更多的应用和程序 去年，外科医生看到了更小的开口，更快的手术时间，更少的感染，更少的好处 并发症和更快的恢复时间。大脑中的管理信息系统程序被接受的速度很慢， 在对大脑进行不可逆转的改变之前，需要验证设备的准确放置。当前 引导导管操作的设备需要复杂的迭代操作，在头骨上打大洞 大脑通达，以及漫长的程序时间。这些因素降低了术中核磁共振成像的吸引力。 然而，许多治疗方法已经成熟，需要改进，例如药物和生物制剂的管理， 放置电极用于治疗(脑深部刺激和癫痫)或监测(癫痫)、消融 癫痫灶，以及脑内出血的排出。术中磁共振成像(MRI) 可以帮助神经外科医生准确地、更有信心地放置设备，使用更少的侵入性 方法比在传统的手术室中进行手术更有可能。仅考虑到帕金森氏症(PD)，新的 治疗方法正在开发中，每年可能使所有60,000名新的PD患者受益， MRI引导的管理信息系统的新市场。 我们提出了一种新的装置，AccuGyd，一种高精度和高精度的钻头和导管导向器，它快速和 易于安装和使用。它可以固定在头骨上，也可以固定在立体定位的框架上。一次核磁共振扫描就能 计算AccuGyd和组织靶标之间的轨迹的屈服信息。的主要优势 AccuGyd用于管理信息系统的技术包括：1)它利用头骨上更小的孔来访问大脑和设备 放置；2)它具有极高的重复性和机械稳定性；3)它大大减少了 核磁共振引导下的手术。此第一阶段项目将专注于将AccuGyd整合到 全面的MRI指导平台，可用于更大的II期研究。第一阶段任务 包括设备本身的进一步开发、原型制造、开发和实施 基于MRI图像特征的AccuGyd最优轨迹确定算法及验证 精确度和精确度使用逼真的头形体模和人头身体。结果将是一个 经过验证的AccuGyd原型，准备进入FDA 510(K)审批流程。

Abstract: The benefits of Minimal Invasive Surgery (MIS) extend to more applications and procedures every year, as surgeons see the benefits of smaller openings, faster procedure times, less infection, fewer complications, and faster recovery times. MIS procedures in the brain have been slow to gain acceptance, due to the need to verify accurate device placement prior to making irreversible changes to the brain. Current devices for guiding catheter procedures require complicated iterative manipulation, large holes in the skull for brain access, and long procedure times. These factors make intraoperative MRI less attractive. However, numerous therapies are ripe for improvement, such as administration of drugs and biologics, placement of electrodes for therapy (deep brain stimulation and epilepsy) or monitoring (epilepsy), ablation of epileptic foci, and evacuation of intracerebral hemorrhages. Intraoperative magnetic resonance imaging (MRI) can assist neurosurgeons in placing devices accurately and with increased confidence, using less invasive methods than possible in the traditional operating room. Considering Parkinson’s Disease (PD) alone, new therapies are under development which could benefit all of the 60,000 new PD patients each year, opening up a new market for MRI-guided MIS. We propose a novel device, “AccuGyd”, a highly accurate and precise drill and catheter guide, that is rapid and easy to install and utilize. It may be affixed either to the skull or a stereotaxic frame. A single MRI scan will yield information to calculate the trajectory between AccuGyd and the tissue target. Major advantages of the AccuGyd technology for MIS include: 1) it utilizes much smaller holes in the skull for brain access and device placement; 2) it is extremely reproducible and mechanically stable; and 3) it substantially reduces the time for an MRI guided procedure. This Phase I project will focus on tasks needed to incorporate AccuGyd into a comprehensive MRI Guidance platform that can be be used in a larger Phase II study. The Phase I tasks include further development of the device itself, prototype fabrication, development and implementation of an algorithm to define the optimal trajectory of the AccuGyd based on MRI image features, and validation of accuracy and precision using a realistic head-shaped phantom and human head cadavers. The result will be a validated AccuGyd prototype that is ready to enter the FDA 510(k) clearance process.