An MRI-Guided Steerable Needle to Replace Open Brain Surgery for Epilepsy Patients

MRI 引导可操纵针替代癫痫患者的开脑手术

基本信息

批准号：
10533332
负责人：
Eric John Barth
金额：
$ 50.73万
依托单位：
VANDERBILT UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-12-15 至 2024-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10533332
关键词：
3D Print Ablation Address Affect Amaze Anatomy Brain Cadaver Cessation of life Cheek structure Clinical Collaborations Craniotomy Curative Surgery Diagnosis Disadvantaged Disease Dose Effectiveness Electrodes Ensure Environment Epilepsy Excision Face Feedback Freedom Geometry High Prevalence Hippocampus Hour Image Imaging Techniques Intervention Knowledge Lasers Letters Life Magnetic Resonance Imaging Mechanics Medical Imaging Methods Monitor Morbidity - disease rate Movement Needles Operative Surgical Procedures Pathway interactions Patients Persons Pharmaceutical Preparations Pharmacotherapy Positioning Attribute Postoperative Period Prevalence Procedures Protocols documentation Public Health Research Research Personnel Risk Robot Robotics Route Safety Scanning Seizures Shapes Surgeon System Systems Integration Technology Temperature Temporal Lobe Epilepsy Thermal Ablation Therapy Thermometry Time Tissues United States Validation Variant Work brain surgery clinical translation cranium curative treatments design design and construction experimental study foramen ovale image guided industry partner innovation minimally invasive multidisciplinary novel patient population robotic system skull base success time use

项目摘要

PROJECT SUMMARY/ABSTRACT Objective: The objective of this proposal is to create a novel MRI-guided steerable needle with the potential to cure epilepsy. Significance: This work is motivated by the prevalence of epilepsy where 1 in 150 people have the disorder (3.4 Million in the US alone), with 30% unresponsive to drug therapy, and 1% of all patients suffering sudden unexplained death each year (i.e. an estimated 500,000 people worldwide – each year!) [1-5]. Amazingly, a proven intervention (surgical removal of the hippocampus) already exists that can cure approximately half of the total epilepsy patient population, yet it is rarely performed due to the invasiveness and perceived morbidity of the procedure [4,6-7]. Our objective in this proposal is to create a novel MRI-guided steerable needle that performs the same function as surgery, but does so through a simple needle insertion. Innovation: Our novel steerable needle will thermally ablate the hippocampus, which is the origin of seizures for 70% of all epilepsy patients. This approach is clinically innovative because it replaces open surgery with percutaneous thermal ablation. Technical innovation comes from (1) a novel helical superelastic steerable needle with anatomy-specific shaping, and (2) a novel 3D printed pneumatic robot that is intrinsically safe and enables real-time MRI guidance and thermometry, with directional laser ablation. We also propose an innovative new pathway for the needle into the brain, via needle insertion into the patient's cheek and passage through a small natural opening in the skull base called the foramen ovale. This pathway is currently used safely for recording electrodes to diagnose epilepsy, but it has never before been used for therapy delivery. Approach: We propose to create our MRI-guided steerable needle system through three Specific Aims. Aim 1 involves designing our MRI-compatible robotic actuation system and the steerable needle itself. Aim 2 focuses on MR imaging protocols for needle localization and MR-thermometry. Aim 3 focuses on validation experiments, including experiments in phantoms, ex vivo tissues, and cadavers to evaluate needle tip placement accuracy, MR guidance and thermometry, and overall system functionality. These Aims will be carried out by a multidisciplinary team of investigators combining expertise in epilepsy surgery (Neimat, Naftel, and Englot), mechanical design and control of MRI-compatible robotic systems (Barth), design and control of steerable needles (Webster), and MR imaging and thermometry (Grissom). The endpoint of this R01 project will be the demonstration of accurate spatial deployment, accurate ablator aiming, and accurate thermal monitoring to ablate a surgeon-prescribed volume of tissue. This will pave the way for clinical translation of this technology after the conclusion of this R01 in collaboration with industry partners (see attached support letters), bringing a potentially curative treatment for epilepsy to many more patients.

项目概要/摘要目的：本提案的目的是创造一种新型 MRI 引导的可操纵针，有可能治愈癫痫。意义：这项工作的动机是癫痫病的流行，每 150 人中就有 1 人患有这种疾病（仅美国就有 340 万人），其中 30% 对药物治疗无反应，所有患者中有 1% 患有突发疾病每年都会出现不明原因的死亡（即全世界每年估计有 500,000 人！）[1-5]。令人惊讶的是，已经存在一种行之有效的干预措施（手术切除海马体）可以治愈这种疾病大约占癫痫患者总数的一半，但由于侵入性，很少进行以及手术的感知发病率 [4,6-7] 我们本提案的目标是创建一种新型 MRI 引导的方法。可操纵的针，具有与手术相同的功能，但通过简单的针插入即可实现。创新：我们的新型可操纵针将热消融海马体，这是癫痫发作的根源对于 70% 的癫痫患者来说，这种方法在临床上具有创新性，因为它取代了开放手术。经皮热消融术的技术创新来自于（1）新型螺旋超弹性可操纵。具有特定解剖形状的针，以及 (2) 本质安全且新颖的 3D 打印气动机器人通过定向激光消融，可以实现实时 MRI 引导和测温。通过将针插入患者的脸颊和通道，将针插入大脑的创新途径通过颅底的一个小天然开口，称为卵圆孔，目前使用此路径。安全地用于记录电极来诊断癫痫，但它从未用于治疗提供。方法：我们建议通过三个具体目标 1 创建 MRI 引导的可操纵针系统。涉及设计我们的 MRI 兼容机器人驱动系统和可操纵针 Aim 2 焦点本身。用于针定位和 MR 测温的 MR 成像协议的重点是验证。实验，包括在体模、离体组织和尸体中进行的实验，以评估针尖放置精度、MR 引导和测温以及整体系统功能将是。由多学科研究人员团队结合癫痫手术的专业知识进行（Neimat、Naftel、和 Englot），MRI 兼容机器人系统的机械设计和控制（Barth），可操纵针 (Webster) 和 MR 成像和测温 (Grissom)。这个R01项目的终点将是精确空间部署、精确消融器的演示瞄准和精确的热监测来消融外科医生规定的组织体积，这将为手术铺平道路。与业界合作完成 R01 后该技术临床转化的途径合作伙伴（见随附的支持信），为更多人带来潜在的癫痫治疗方法患者。