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

项目摘要/摘要 目的：本方案的目的是创造一种新的MRI引导的可定向针具，有可能 治愈癫痫。 意义：这项工作的动机是癫痫的流行，每150人中就有一人患有这种疾病 (仅在美国就有340万人)，30%的患者对药物治疗没有反应，1%的患者突然 每年原因不明的死亡(即估计全世界每年有50万人！)[1-5]。 令人惊讶的是，已经存在一种经过验证的干预措施(手术切除海马体)可以治愈 约占癫痫患者总数的一半，但由于其侵袭性，很少进行手术 和感知的手术发病率[4，6-7]。我们在这项提案中的目标是创建一种新的MRI引导的 一种可定向的针，其功能与外科手术相同，但只需简单的插入针头即可。 创新：我们的新型可转向针将热消融海马体，海马体是癫痫发作的来源 适用于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(1)新型螺旋超弹性转向装置 具有特定解剖形状的针，以及(2)一种新型3D打印气动机器人，本质上安全， 通过定向激光消融，实现实时核磁共振引导和测温。我们还提出了一个 创新的针进入大脑的新途径，通过将针插入患者的脸颊和通道 通过头骨底部的一个叫做卵圆孔的小的自然开口。这条路径目前正在使用 记录电极用于诊断癫痫是安全的，但它以前从未被用于治疗。 方法：我们建议通过三个具体目标创建我们的MRI引导的可定向穿刺针系统。目标1 包括设计我们的核磁共振兼容的机器人驱动系统和可转向的针头本身。目标2重点 关于用于针头定位和磁共振测温的磁共振成像方案。目标3侧重于验证 实验，包括在体模、体外组织和身体上评估针尖的实验 放置精度、MR制导和测温，以及整个系统功能。这些目标将是 由一个结合癫痫外科专业知识的多学科调查团队进行(Neimat，Naftel， 和Englot)，磁共振兼容机器人系统的机械设计和控制(Barth)，设计和控制 可转向针(韦伯斯特)和磁共振成像和测温(格里森)。 这个R01项目的终点将是精确的空间展开、精确的烧蚀器的演示 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 与产业界合作，在本次R01会议结束后，该技术的临床翻译方法 合作伙伴(见所附的支持信)，为更多人带来了一种潜在的癫痫治疗方法 病人。

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.