MINIR-II: Minimally Invasive Neurosurgical Intracranial Robot

项目摘要 这个R01项目建立在一个非常成功的R21项目的基础上，该项目涉及开发和可行性 基于形状记忆合金(SMA)的微创神经外科颅内机器人 致动器及其在连续磁共振下对种植体切除装置的评价 猪脑的“转移性肿瘤”。在我们实现R21项目的具体目标的同时，我们也发现 新的挑战，这是R01应用的基础。脑瘤是最令人畏惧的 癌症并发症发生在20%-40%的成年癌症患者中。尽管在以下方面取得了许多进展 治疗后，这些患者预后较差，中位生存期为4-8个月。无论是一种 原发性(固有)恶性肿瘤，或继发性(转移性)恶性肿瘤，大脑受累于 癌症患者是毁灭性的，因为它威胁到个人的个性和身份， 而且总是所有并发症中最有可能直接和严重影响生活质量的。 目前，大多数脑肿瘤的最佳治疗方法是一期手术切除以利于 辅助治疗，如放射和化疗。不幸的是，许多患者不能 由于病变位置不佳而直接手术切除脑肿瘤(通常 传统神经外科技术无法达到的深度或其他方面)，以及一般健康状况较差 病人。为了解决这个问题，基于我们R21试点项目的成功，以及 从中吸取的经验教训，我们建议开发完全与MRI兼容的mini R-II和 通过全面展示mini R-II的安全性和有效性 猪的体内外临床相关性评价及人的追踪研究 身体模型。正如设想的那样，mini R-II将由医生直接控制， 目标定位信息仅从使用主动目标定位方法的实时MRI获得 嵌入到微型R-II中的传感器。为了实现mini R-II，我们将解决四个具体目标：1)设计 一种与MRI完全兼容的带缆索的多自由度Mini R-II刚性塑料体 驱动接头，用于布线和电子设备的中空内芯，灌溉和吸水能力， 和肿瘤去除能力，2)开发并表征了一种能够成型的多件模具 几何形状复杂的机器人与微型特征相连，实现完全一次性/一次性使用 Mini R-II原型，3)为mini R-II开发一个跟踪和导航系统，将允许可视化 近端和远端结构，用于肿瘤的准确靶向和切除，最后4) Mini R-II在明胶模体和临床相关脑转移瘤模型中的安全性和有效性 肿瘤模型包括身体猪模型、活猪模型和人身体模型。我们最终的目标 该项目的重点是使mini R-II(在连续核磁共振下运行)准备好进行临床试验。

Project Summary This R01 project builds on a highly successful R21 project which involved the development and feasibility of a Minimally Invasive Neurosurgical Intracranial Robot (MINIR-I) using shape memory alloy (SMA) actuators as well as the evaluation of the device under continuous MRI for resection of an implanted “metastatic tumor” in swine brain. While we achieved the specific aims of the R21 project, we also discovered new challenges, which are the basis for this R01 application. Brain tumors are among the most feared complications of cancer occurring in 20–40% of adult cancer patients. Despite numerous advances in treatment, the prognosis for these patients is poor, with a median survival of 4–8 months. Whether a primary (intrinsic) malignancy, or a secondary (metastatic) malignancy, involvement of the brain in a cancer patient is devastating, because it threatens the very personality and identity of the individual, and is invariably the most likely of all complications to directly and severely affect the quality of life. Currently, the optimal treatment for most brain tumors involves primary surgical resection to facilitate adjuvant therapies such as radiation and chemotherapy. Unfortunately, many patients cannot undergo primary surgical resection of their brain tumor due to unfavorable location of the lesion (usually deep or otherwise inaccessible to conventional neurosurgical techniques), and poor general health of the patient. To address this problem, based on the success of our R21 pilot project, and the lessons learned therein, we propose to develop a fully MRI-compatible MINIR-II and demonstrate the safety and efficacy of MINIR-II through comprehensive assessments on clinically relevant ex vivo and in vivo swine and followed by human cadaver models. As envisioned, MINIR-II will be under the direct control of the physician, with targeting information obtained exclusively from real-time MRI that uses active targeting methods with the sensors embedded within MINIR-II. To realize MINIR-II, we will address four specific aims: 1) Design a fully MRI compatible multiple degree-of-freedom (DOF) MINIR-II of rigid plastic body with cable driven joints, hollow inner core for routing cabling and electronics, irrigation and suction capability, and tumor removal capability, 2) Develop and characterize a multi-piece mold capable of molding geometrically complex robot links with miniature features to produce a completely disposable/single use MINIR-II prototype, 3) Develop a tracking and navigation system for MINIR-II that will allow visualization of proximal and distal structures for accurate targeting and resection of the tumor, and finally 4) the safety and efficacy of MINIR-II in gelatin phantoms and clinically relevant models of metastatic brain tumor including, a cadaveric pig model, a live pig model, and a human cadaver model. Our goal at the end of this project is to have MINIR-II (operated under continuous MRI) ready for clinical trials.