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

安全、快速地进入内耳道治疗听神经瘤

• 批准号: 8610913
• 负责人: Robert James Webster
• 金额: $ 36.03万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-02-15 至 2017-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8610913
• 关键词: Acoustic Neuroma; Address; Anatomy; Animals; Area; Auditory; Biomechanics; Cadaver; Cattle; Clinical; Cochlear implant procedure; Computer software; Data; Devices; Dimensions; Dissection; Ear; Emergency Situation; Ensure; Excision; Facial nerve structure; Geometry; Goals; Hour; Human; Image; Institutional Review Boards; Judgment; Labyrinth; Length; Malignant Neoplasms; Manuals; Mastoid process; Measures; Medical Imaging; Methods; Monitor; Motion; Motivation; Nerve; Operative Surgical Procedures; Output; Pathology; Patients; Performance; Phase; Positioning Attribute; Postoperative Period; Prevention; Procedures; Process; Risk; Robot; Robotics; Safety; Scanning; Speed; Structure; Surgeon; System; Techniques; Technology; Temporal bone structure; Time; Torque; Training; Travel; United States Food and Drug Administration; Validation; Work; X-Ray Computed Tomography; bone; bone geometry; cranium; design; dexterity; imaging Segmentation; improved; innovation; instrument; multidisciplinary; patient safety; public health relevance; research study; robot assistance; sensor; skills; skull base; theories; tool; tumor; validation studies

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.

描述（由申请人提供）：我们建议采用图像引导的平行机器人技术来创建机器人，以帮助外科医生进行声学神经瘤手术，提高苛刻的声学神经瘤删除程序的安全性和功效，这需要非常精确。该手术程序可以从使用机器人工具中受益，因为（1）钻轨迹的准确性对于安全性和有效性至关重要（至关重要（重要结构在于必须去除的骨骼附近），并且（2）它涉及在骨膜内不包裹在骨骼中的重要结构刚性解剖结构。 我们的假设更快，更安全，可以通过结合图像引导的手术技术和直接附着在骨骼上的微型平行机器人来实现重要的内耳结构。我们工作中的临床创新源于以下事实：声学神经瘤手术从未从机器人援助中受益，而当前的手术机器人由于其大小和/或缺乏余化而无法准确注册给患者，因此目前的手术机器人无法实现。技术创新源于以下事实：声学神经瘤手术需要最小，最轻的机器人，才能达到其具有挑战性的准确性，力量，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，设计和控制理论中进行创新。为了实现这一目标，我们提出了三个具体目标。 AIM 1解决了我们提出的声学神经瘤手术机器人（ANSR）的设计。我们将根据生物力学力，扭矩和手术钻的速度来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的手术系统。在AIM 2中，我们将计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的安全。我们将采用已建立的注册技术，并创建新软件，该软件生成特定于患者的运动计划，该计划避免了重要的结构并最大程度地减少手术时间，从而降低了患者的风险。为了确保患者的安全，我们将包括节流，跟踪阻塞预防，紧急停止，钻孔监测，冗余感应和神经监测。最后，在AIM 3中，我们将使用完整的机器人系统对幻像，体内动物骨骼和人尸体进行实验验证研究。在此R01结束时，我们将拥有成熟的硬件和软件平台，并将通过食品药品监督管理局的研究设备豁免过程收集足够的幻影，动物和尸体数据。