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

• 批准号: 10312131
• 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
• 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/10312131
• 关键词: 3D Print; Ablation; Address; Affect; Anatomy; Brain; Cadaver; Cessation of life; Cheek structure; Clinical; Collaborations; Craniotomy; Diagnosis; Disadvantaged; Disease; Dose; Effectiveness; Electrodes; Ensure; Environment; Epilepsy; Excision; Face; Feedback; Freedom; Geometry; High Prevalence; Hippocampus (Brain); Hour; Image; 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; Savings; Scanning; Seizures; Shapes; Surgeon; System; Technology; Temperature; Temporal Lobe Epilepsy; Thermal Ablation Therapy; Thermometry; Time; Tissues; United States; Validation; Variant; Work; base; 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

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.

项目总结/摘要 目的：本提案的目的是创建一种新型MRI引导可控针， 治疗癫痫 意义：这项工作的动机是癫痫的患病率，150人中有1人患有这种疾病 (3.4仅在美国就有100万人），其中30%对药物治疗没有反应，1%的患者患有突发性疾病 每年有500，000人死于不明原因的死亡（即全球每年估计有500，000人死亡！）[1-5]中所述。 令人惊讶的是，已经有一种经过验证的干预措施（手术切除海马体）可以治愈 大约一半的癫痫患者，但由于侵入性，很少进行 [14]《明史》卷17：6。我们在这项提案中的目标是创造一种新的MRI引导的 可操纵针，其执行与手术相同的功能，但通过简单的针插入来实现。 创新：我们的新型可控针将热消融海马体，这是癫痫发作的起源 70%的癫痫患者。这种方法在临床上是创新的，因为它取代了开放手术， 经皮热消融技术创新来自于（1）一种新型螺旋超弹性可操纵 具有解剖学特定形状的针，以及（2）本质安全的新型3D打印气动机器人， 通过定向激光消融实现实时MRI引导和测温。我们也提出了一个 创新的新途径，通过针头插入病人的脸颊和通道， 穿过颅底上一个叫做卵圆孔的天然小孔目前，这一途径被用于 安全地记录电极来诊断癫痫，但它以前从未被用于治疗输送。 方法：我们建议通过三个特定目标创建我们的MRI引导可操纵针系统。要求1 包括设计我们的MRI兼容机器人驱动系统和可操纵针本身。目标2重点 针定位和MR测温的MR成像协议。目标3侧重于验证 实验，包括在体模、离体组织和尸体中进行的实验，以评价针尖 放置精度、MR引导和温度测量以及整体系统功能。这些目标将是 由一个多学科的研究小组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（韦伯斯特）和MR成像和测温（Grissom）。 该R 01项目的终点将是证明准确的空间部署、准确的消融器 瞄准和精确的热监测，以消融外科医生规定的组织体积。这将为 在与行业合作完成本R 01后，该技术的临床转化方式 合作伙伴（见所附的支持信），为更多的癫痫患者带来了潜在的治愈性治疗。 患者