Neurosurgical Intracerebral Hemorrhage Evacuation (NICHE) Robot

描述（由申请人提供）：自发性幕上脑出血（ICH）每年在全球范围内发生H200万人，是一个主要的全球公共卫生问题。 ICH与32- 50%的30天死亡率相关，并且仅20-25%的存活此类脑出血的个体实现了6个月的功能独立。 人们普遍认为，清除血凝块应该是ICH患者早期治疗的一个重要目标，但尽管理论上有好处，传统开颅术清除ICH仍然存在争议，因为缺乏明确的疗效证据。 微创手术（MIS）对脑组织造成的创伤最小，并在90天时显著提高了功能独立患者的数量。 然而，这种明显的益处在很大程度上被高再出血率所抵消。 目前用于去除ICH的技术具有严重的局限性。 所有目前可用的ICH后送MIS方法均采用视线、刚性 管. 因此，它们通常依赖于酶促血栓溶解剂[例如，尿激酶或组织纤溶酶原激活剂（rtPA）]引入血凝块中以使其溶解，然后将其冲洗出来。 酶溶栓有两个重要的局限性。 首先，它非常慢，需要 多次注射血栓溶解剂和超过24小时以减少ICH体积。 因此，完全丧失了快速降低颅内压的潜在益处，这可以挽救生命。 此外，酶促血栓溶解可能是危险的，因为无法控制血栓溶解剂扩散的位置，因此再出血率高得不可接受。 目前迫切需要开发一种替代技术，用于ICH的清除，而不会增加再出血的风险。 我们设想了一种用于脑出血清除的神经外科脑出血清除（NICHE）机器人，该机器人将：a）与成像模式兼容，B）直径为6 mm，长约20 cm，以允许通过冠状缝喙侧的非功能性额叶皮质部署到基底节或丘脑中的深ICH中，c）通过多个自由度（DOF）离散驱动，机器人的尖端连杆能够弯曲成“J形”，以允许在直线之外去除ICH瞄准轨迹和附加接头，以允许在ICH内定位头端连接件，d） 配备有贯穿其中空芯部的抽吸和冲洗管线，并具有双极电烙探针以固定ICH，以及e）始终在神经外科医生的即时和直接指导下。 为了实现NICHE机器人，我们将解决三个具体目标：1）设计和开发一种多关节离散驱动和可操纵的NICHE机器人，带有双极电烙探针和用于电烙ICH的抽吸和冲洗通道，2）开发一种术中成像算法，用于精确、实时跟踪机器人插管，并使用低辐射剂量锥形束CT监测ICH排空的进展，3）在临床相关脑出血模型中验证NICHE机器人的安全性和有效性。

DESCRIPTION (provided by applicant): Spontaneous supratentorial intracerebral hemorrhage (ICH) occurs in H2 million people worldwide every year and represents a major global public-health problem. ICH is associated with a 30-day mortality rate of 32-50%, and 6 month functional independence is achieved in only 20-25% of individuals who survive such hemorrhages. It is widely accepted that removal of the blood clot should be an important goal of early management of patients with ICH, but despite theoretical benefits, classic craniotomy for ICH removal remains controversial, because clear evidence of efficacy is lacking. Minimally invasive surgery (MIS) causes minimal trauma to brain tissues and significantly improves the number of functionally independent patients at 90 days. However, this apparent benefit is largely negated by high rates of rebleeding. Current technologies to remove ICH have serious limitations. All currently available methods of MIS for ICH evacuation employ line-of-sight, rigid tubes. Because of this, they generally rely on enzymatic thrombolytic agents [e.g., urokinase or tissue plasminogen activator (rtPA)] introduced into the clot to liquefy it, prior to irrigating itout. There are two important limitations with enzymatic thrombolysis. First, it is very slow, requiring multiple injections of thrombolytic agents and more than 24 hours to reduce ICH volume. Therefore, the potential benefit of rapidly reducing intracranial pressure, which can be lifesaving is completely lost. In addition, enzymatic thrombolysis can be dangerous, since there is no control over where the thrombolytic agent diffuses and thus re-hemorrhage rates are unacceptably high. There is a clear and urgent need to develop an alternative technology for evacuation of ICH without increasing the risk of rebleeding. We envision a Neurosurgical Intracerebral Hemorrhage Evacuation (NICHE) robot for ICH removal that will be: a) compatible with the imaging modality, b) 6 mm in diameter and about 20 cm long to allow deployment into a deep ICH in the basal ganglia or thalamus via non-eloquent frontal lobe cortex rostral to the coronal suture, c) discretely actuated with multiple degrees-of-freedom (DOFs) and the tip link of the robot having the capability to bend into a "J-shape" to allow ICH removal outside of the line-of-sight trajectory and additional joints to allow positioning the tip link within the ICH, d) equipped with suction and irrigation lines running through its hollow core and have bipolar electrocautery probes to liquefy the ICH, and e) under the immediate and direct guidance of the neurosurgeon at all times. To realize the NICHE robot, we will address three specific aims: 1) Design and develop a multi-joint discretely actuated and steerable NICHE robot with bipolar electrocautery probes and a suction and irrigation channel for electrocauterizing the ICH, 2) Develop an intra-operative imaging algorithm for precise, real-time tracking of robotic cannula and to monitor the progress of ICH evacuation using low radiation dose cone-beam CT, and 3) Demonstrate the safety and efficacy of NICHE robot in clinically relevant models of ICH.