MRI-Compatible Robot for Real-Time Image-Guided Stereotactic Neurosurgical Procedures: A Novel Platform Technology

用于实时图像引导立体定向神经外科手术的 MRI 兼容机器人：一种新颖的平台技术

• 批准号: 10181508
• 负责人: Reza Monfaredi
• 金额: $ 49.79万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-20 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10181508
• 关键词: Ablation; Address; Anesthesia procedures; Area; Arthroscopy; Biopsy; Brain; Brain Neoplasms; Brain imaging; Cadaver; Cephalic; Child; Childhood; Clinical; Clinical Research; Complex; Complication; Consumption; Development; Devices; Diagnostic Procedure; Disease; Ensure; Epilepsy; Freedom; Funding; Goals; Head; Hemorrhage; Hospitals; Hour; Human; Image; Image-Guided Surgery; Injections; Intervention; Logistics; Magnetic Resonance Imaging; Malignant Neoplasms; Manuals; Maps; Medical Device; Medical center; Methods; Morbidity - disease rate; Needle biopsy procedure; Needles; Neoplasm Metastasis; Neurosurgeon; Neurosurgical Procedures; Operative Surgical Procedures; Outcome; Pain; Parkinson Disease; Patient Care; Patients; Pediatric Hospitals; Phase; Planning Techniques; Positioning Attribute; Postoperative Hemorrhage; Procedures; Research; Rewards; Risk; Robot; Robotics; Safety; Structure; Supervision; Surgeon; System; Techniques; Technology; Testing; Time; United States; United States National Institutes of Health; Validation; Visualization; Work; X-Ray Computed Tomography; base; blind; clinical development; cost; cranium; design; design and construction; experience; image guided; image guided intervention; imaging modality; improved; instrument; interest; mortality; neurosurgery; novel; operation; procedure safety; real-time images; robotic system; soft tissue; tumor

Project Summary/Abstract This project aims to develop a novel MRI-compatible robotic system with an integrated imaging coil array to enable in-bore real-time interventional procedures, improve the targeting accuracy, shorten the pre-operative path planning time, and intra-operative surgery time. Currently, neurosurgeons often use pre-operative MRI to plan the path manually and place the instrument in the brain outside of the MRI room either manually using a passive stereotactic frame, or by using non-MRI compatible robots such as ROSA. Performing neurosurgical procedures using real-time MRI-guidance requires an enabling technology for in-bore interventions. Although an MRI-compatible commercial device has been recently introduced, ClearPoint, for real-time MRI-guided targeting, it is passive and thus requires time consuming manual adjustment. It is also not appropriate for multi- target application as it is locally mounted on the skull. For tumor biopsy and ablation, path planning currently requires the neurosurgeon to perform extensive manual preoperative planning which can require one hour or more. Despite extensive pre-planning, intra-operative re-planning is sometimes required once the skull is opened. Lastly, current imaging head coils have been designed specifically for diagnostic procedures, encompassing the patient’s head and limiting access to the surgical area. Consequently, current procedures are time-intensive, especially for multi-target procedures. There are no existing medical device technologies that can address all the major neurosurgery challenges of: 1) lengthy blind procedure time for single-/multi-target procedures, 2) limited brain access due to the MR imaging coil, and 3) extensive manual path planning. We propose to develop an MRI-compatible and low-profile novel robotic system with embedded movable coil array for real-time in-bore application featured with automatic path planning techniques. The specific aims of the proposed research are to (1) Design, construct, and test an MRI-compatible robot with an automatic path planner, (2) Develop an embedded MR coil array, and (3) Integrate the system components and evaluate the system accuracy. The successful completion of the proposed project will provide the necessary technical feasibility and workflow validation information to support development of clinically viable system for human trial in the next phase.

项目总结/摘要 该项目旨在开发一种新型的MRI兼容机器人系统，该系统具有集成成像线圈阵列， 实现孔内实时介入手术，提高靶向准确性，缩短术前 路径规划时间和术中手术时间。目前，神经外科医生经常使用术前MRI来 手动规划路径，并将仪器放置在MRI室外部的大脑中， 被动立体定向框架，或通过使用非MRI兼容机器人，如ROSA机器人。进行神经外科手术 使用实时MRI引导的程序需要用于孔内介入的使能技术。虽然 最近推出了MRI兼容的商业设备ClearPoint ™，用于实时MRI引导 瞄准时，它是被动的，因此需要耗时的手动调整。它也不适合多- 目标应用，因为它是局部安装在头骨上。对于肿瘤活检和消融，路径规划目前 需要神经外科医生进行广泛的手动术前计划，这可能需要一个小时， 更多.尽管进行了广泛的预先计划，但一旦颅骨破裂，有时需要进行术中重新计划。 打开最后，目前的成像头部线圈是专门为诊断程序设计的， 包围患者的头部并限制进入手术区域。因此，目前的程序 时间密集型，特别是对于多靶点手术。没有现有的医疗器械技术可以 解决所有主要的神经外科挑战：1）单/多靶点盲法手术时间过长 2）由于MR成像线圈导致的有限的大脑通路，以及3）大量的手动路径规划。我们 我建议开发一种兼容MRI的低轮廓新型机器人系统，该系统具有嵌入式可移动线圈阵列 用于具有自动路径规划技术的实时孔内应用。该委员会的具体目标 提出的研究是（1）设计、构造和测试具有自动路径规划器的MRI兼容机器人， (2)开发嵌入式MR线圈阵列;（3）集成系统组件并评估系统 精度拟议项目的顺利完成将提供必要的技术可行性， 工作流程验证信息，以支持在未来开发临床可行的人体试验系统 相位