Neurosurgical Intracerebral Hemorrhage Evacuation (NICHE) Robot

描述(由申请人提供)：全球每年有820万人发生自发性幕上脑出血(ICH)，是一个重大的全球公共卫生问题。ICH与32-50%的30天死亡率有关，仅有20%-25%的存活患者在6个月内实现了功能独立。人们普遍认为，清除血块应该是脑出血患者早期治疗的重要目标，但尽管理论上有好处，传统的开颅手术清除脑出血仍然存在争议，因为缺乏明确的有效性证据。微创手术对脑组织造成最小的创伤，并在90天内显著提高功能独立患者的数量。然而，这种明显的好处在很大程度上被高的再出血率所抵消。目前消除脑出血的技术有严重的局限性。目前所有可用的非物质文化遗产疏散管理信息系统方法都采用视线、僵化 管子。正因为如此，他们通常依赖于酶溶栓剂[例如，尿激酶或组织型纤溶酶原激活剂(RtPA)]引入血栓中，在冲洗之前将其液化。酶溶栓有两个重要的局限性。首先，它非常慢，需要 多次注射溶栓剂及24小时以上以减少脑出血量。因此，可以挽救生命的快速降低颅内压的潜在好处完全丧失了。此外，酶溶栓可能是危险的，因为无法控制溶栓剂在哪里扩散，因此再出血率高得令人无法接受。显然，迫切需要开发一种替代技术，在不增加再次出血风险的情况下疏散非脑组织出血。 配备了贯穿其中空核心的抽吸和冲洗管路，并配备了两极电灼探头来液化脑出血，以及e)在神经外科医生的立即和直接指导下。为了实现壁龛机器人，我们将致力于三个具体目标：1)设计和开发一个具有双极电灼探头和用于电灼脑出血的吸入和冲洗通道的多关节离散驱动和可操纵的壁龛机器人；2)开发一种术中成像算法，以精确、实时地跟踪机器人插管并使用低辐射剂量锥束CT监测脑出血疏散过程；以及3)在临床相关的脑出血模型中展示壁龛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.