Safe, Rapid Access to the Internal Auditory Canal for Acoustic Neuroma

描述（由申请人提供）：我们建议应用图像引导平行机器人技术来创造一个机器人来辅助外科医生进行听神经瘤手术，提高要求极高的精度的听神经瘤切除手术的安全性和有效性。这种手术过程得益于机器人工具的使用，因为：(1)钻头轨迹的准确性对安全性和有效性至关重要，（重要结构靠近必须移除的骨骼）；(2)它涉及到骨骼中包裹着重要结构的刚性解剖，在手术干预期间不会变形。我们的假设是，通过结合图像引导手术技术和直接附着在骨头上的微型平行机器人，可以实现更快速、更安全、更准确地进入重要的内耳结构。我们工作中的临床创新来自于这样一个事实，即听神经瘤手术以前从未受益于机器人辅助，目前的手术机器人由于其体积和/或缺乏准确记录患者的能力而无法实现。技术创新源于这样一个事实，即听神经瘤手术需要最小、最轻的机器人，以达到其具有挑战性的精度、力、速度和工作空间要求。同时优化所有这些因素需要在机器人技术、设计和控制理论方面进行创新。为此，我们提出三个具体目标。目的1阐述了我们提出的听神经瘤手术机器人（ANSR）的设计。我们将根据手术钻头的生物力学力、扭矩和速度确定最佳性能的设计参数，然后构建ANSR机器人和相关的图像引导手术系统。在目标2中，我们将规划手术路径并控制机器人系统，同时实施多种冗余措施以确保患者安全。我们将应用现有的注册技术，并创建新的软件，生成患者特定的运动计划，避免重要结构，最大限度地减少手术时间，从而降低患者的风险。为了确保患者安全，我们将包括节流、跟踪闭塞预防、紧急停止、钻力监测、冗余传感和神经监测。最后，在Aim 3中，我们将使用完整的机器人系统在幽灵，离体动物骨骼和人类尸体中进行实验验证研究。在R01结束时，我们将拥有成熟的硬件和软件平台，并将收集足够的幻影，动物和尸体数据，通过食品和药物管理局的研究器械豁免程序转移到人类研究。

DESCRIPTION (provided by applicant): We propose to apply image-guided parallel robotic technology to create a robot to assist surgeons with acoustic neuroma surgery, improving both the safety and efficacy of demanding acoustic neuroma removal procedures, which require extraordinary precision. This surgical procedure can benefit from the use of a robotic tool because (1) the accuracy of the drill trajectory is of paramount importance for both safety and efficacy, (vital structures lie in close proximity to the bone that must be removed) and (2) it involves rigid anatomy with vital structures encased in bone which does not deform during surgical intervention. Our hypothesis is more rapid, safer, and more accurate access to vital inner-ear structures can be achieved by combining image-guided surgical techniques and miniature parallel robots directly attached to the bone. The clinical innovation in our work comes from the fact that acoustic neuroma surgery has never before benefited from robotic assistance and current surgical robots are not capable of achieving it due to their size and/or lack of abilit to be accurately registered to the patient. Technical innovation comes from the fact that acoustic neuroma surgery requires the smallest, lightest robot that can achieve its challenging accuracy, force, speed, and workspace requirements. Simultaneous optimization of all these factors requires innovation in robot technology, design, and control theory. To achieve this we propose three specific aims. Aim 1 addresses the design our proposed acoustic neuroma surgery robot (ANSR). We will determine design parameters for optimal performance in terms of biomechanical forces, torques, and speeds for surgical drill, and then construct the ANSR robot and associated image-guided surgical system. In Aim 2 we will plan the surgical path and control the robotic system while implementing multiple redundant measures to ensure patient safety. We will apply established registration techniques and create new software that generates a patient-specific motion plan which avoids vital structures and minimizes surgery time, thereby reducing risk to patients. To ensure patient safety, we will the will include throttling, tracking occlusion prevention, emergency stops, drill force monitoring, redundant sensing, and nerve monitoring. Lastly, in Aim 3 we will perform experimental validation studies in phantoms, ex vivo animal bones, and human cadavers using the complete robot system. At the conclusion of this R01, we will have mature hardware and software platforms and will have collected sufficient phantom, animal, and cadaver data to move to human studies through the Food and Drug Administration's Investigational Device Exemption process.