AccuGyd: Accurate Guidance for MRI-Guided Minimally Invasive Neurosurgery

AccuGyd：MRI 引导微创神经外科手术的准确指导

• 批准号: 10258259
• 负责人: TERRENCE R OAKES
• 金额: $ 35.29万
• 依托单位: IMGGYD LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10258259
• 关键词: Ablation; Adopted; Adoption; Algorithms; Application procedure; Area; Biological; Brain; Cadaver; Catheters; Cerebral hemisphere hemorrhage; Cerebrospinal Fluid; Complex; Computer software; Deep Brain Stimulation; Development; Device or Instrument Development; Devices; Doctor of Philosophy; Electric Stimulation; Electrodes; Environment; Epilepsy; Extravasation; FDA approved; Feedback; Foundations; Head; Hour; Human; Human Resources; Image; Improve Access; Infection; Intellectual Property; Legal patent; Location; MRI Scans; Madura; Magnetic Resonance Imaging; Malignant neoplasm of brain; Mechanics; Medicine; Methods; Monitor; Neurosurgeon; Normal tissue morphology; Operating Rooms; Operative Surgical Procedures; Parkinson Disease; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase; Procedures; Process; Radial; Recovery; Reproducibility; Research; Resources; Solid; Specific qualifier value; Surgeon; Techniques; Technology; Testing; Time; Tissues; Training; Trephine hole; United States National Institutes of Health; Validation; Wisconsin; arm; base; brain surgery; cost; cranium; deep brain stimulator; design; gene therapy; image guided; improved; indexing; infection risk; millimeter; minimally invasive; neurosurgery; novel; novel therapeutics; phase 2 study; prototype; rare genetic disorder

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.

翻译后摘要：微创手术（MIS）的好处扩展到更多的应用程序和程序， 今年，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 并发症和更快的恢复时间。大脑中的MIS程序获得接受的速度很慢， 需要在对大脑造成不可逆的改变之前验证准确的设备放置。电流 用于引导导管手术的装置需要复杂的反复操作， 大脑通路和漫长的手术时间这些因素使得术中MRI不那么有吸引力。 然而，许多治疗方法已经成熟，可以改进，例如药物和生物制剂的施用， 用于治疗（脑深部电刺激和癫痫）或监测（癫痫）的电极放置， 癫痫灶和脑内血肿清除。术中磁共振成像（MRI） 可以帮助神经外科医生准确地放置设备，并增加信心， 在传统的手术室里，仅考虑帕金森病（PD），新 治疗正在开发中，每年可使所有60，000名新的PD患者受益， MRI引导MIS的新市场。 我们提出了一种新的设备，“AccuGyd”，一个高度准确和精确的钻和导管引导，这是快速和 易于安装和使用。它可以固定在颅骨或立体定位框架上。一次核磁共振扫描 产生信息以计算AccuGyd和组织靶点之间的轨迹。的主要优点 MIS的AccuGyd技术包括：1）它利用头骨上更小的孔来进行脑部访问和设备 2）它是非常可再现的和机械稳定的;和3）它大大减少了放置的时间。 核磁共振成像引导手术该第一阶段项目将重点关注将AccuGyd纳入 全面的MRI引导平台，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、 基于MRI图像特征定义AccuGyd最佳轨迹的算法，以及 准确度和精密度使用逼真的头形体模和人头尸体。结果将是一个 经过验证的AccuGyd原型已准备好进入FDA 510（k）许可流程。