Neurosurgical Intracerebral Hemorrhage Evacuation (NICHE) Robot

神经外科脑出血清除（NICHE）机器人

• 批准号: 8853860
• 负责人: JAYDEV P. DESAI
• 金额: $ 10.62万
• 依托单位: UNIV OF MARYLAND, COLLEGE PARK
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-01 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8853860
• 关键词: Address; Algorithms; Alteplase; Attention; Basal Ganglia; Blood coagulation; Brain; Caliber; Cannulas; Cerebral hemisphere hemorrhage; Characteristics; Coagulation Process; Conventional Surgery; Craniotomy; Diagnostic radiologic examination; Diffuse; Electrocoagulation; Excision; Fibrinolytic Agents; Freedom; Goals; Hematoma; Hemorrhage; Hour; Image; Individual; Infusion procedures; Injection of therapeutic agent; Intracranial Pressure; Irrigation; Joints; Length; Link; Local anesthesia; Low Dose Radiation; Measures; Medical; Methods; Modeling; Monitor; Neurosurgeon; Operative Surgical Procedures; Patients; Positioning Attribute; Procedures; Public Health; Risk; Robot; Robotics; Running; Safety; Scanning; Shapes; Speculums; Suction; Supratentorial; Surface; Technology; Thalamic structure; Time; Tissues; Trauma; Traumatic Brain Injury; Tube; Urokinase; Vision; X-Ray Computed Tomography; brain tissue; clinically relevant; cone-beam computed tomography; coronal suture; design; flexibility; frontal lobe cortex; imaging modality; improved; minimally invasive; mortality; programs; public health relevance; randomized trial; thrombolysis

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.

描述（由申请人提供）：全世界每年有 200 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 天死亡率相关，只有 20-25% 的出血患者能够实现 6 个月的功能独立。 人们普遍认为，清除血凝块应该是脑出血患者早期治疗的一个重要目标，但尽管理论上有好处，但经典开颅手术去除脑出血仍存在争议，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，并且显着提高了 90 天后功能独立的患者数量。 然而，这种明显的好处在很大程度上被高再出血率所抵消。 目前消除 ICH 的技术有严重的局限性。 目前所有用于 ICH 疏散的 MIS 方法均采用视线、刚性 管。 因此，他们通常依赖于将酶促溶栓剂[例如尿激酶或组织纤溶酶原激活剂（rtPA）]引入凝块中以将其液化，然后再将其冲洗掉。 酶溶栓有两个重要的局限性。 首先，它非常慢，需要 多次注射溶栓剂并持续24小时以上，以减少ICH体积。 因此，快速降低颅内压可以挽救生命的潜在益处就完全丧失了。 此外，酶促溶栓可能是危险的，因为无法控制溶栓剂扩散的位置，因此再出血率高得令人无法接受。 显然迫切需要开发一种在不增加再出血风险的情况下疏散 ICH 的替代技术。 我们设想用于 ICH 清除的神经外科脑出血清除 (NICHE) 机器人将：a) 与成像模式兼容，b) 直径 6 毫米，长约 20 厘米，允许通过冠状缝吻侧的非口语额叶皮质部署到基底节或丘脑的深层 ICH 中，c) 离散 以多个自由度 (DOF) 驱动，机器人的尖端连杆能够弯曲成“J 形”，以允许将 ICH 移至视线轨迹之外，并附加关节以允许将尖端连杆定位在 ICH 内，d) 配备穿过其空心的抽吸和冲洗管线，并配有双极电灼探头以液化 ICH，以及 e) 始终在神经外科医生的直接指导下进行。 为了实现 NICHE 机器人，我们将实现三个具体目标：1）设计和开发多关节离散驱动和可操纵的 NICHE 机器人，配有双极电灼探头以及用于电灼 ICH 的抽吸和冲洗通道，2）开发术中成像算法，用于精确、实时跟踪机器人插管并使用低辐射剂量监测 ICH 疏散进度 锥束CT，以及3）展示NICHE机器人在ICH临床相关模型中的安全性和有效性。