Debulking From Within: A Steerable Needle for Intracerebral Hemorrhage Aspiration

描述(由申请人提供)：本方案的目标是设计、建造和评估一种可引导的针，从内部以较小的侵入性清除脑出血(ICH)。这是因为每50个人中就有一个人在一生中会有一次脑出血，无论是否尝试手术减压，死亡率都有40%。尽管手术有能力对有风险的组织进行减压，但手术并没有产生更好的整体临床结果的一个原因可能是因为仅仅为了进入手术部位就破坏了大量的健康脑组织。为了提供一种更安全地实现减压的方法，我们建议创建一种系统，能够通过针头大小的进入路径在不广泛暴露的情况下清除脑出血引起的血肿。我们的新的可导向针系统将使用超弹性、预弯的抽吸套管从内部清除血肿，该导管通过直通的外针部署在血肿内。通过针和插管的协调直线运动和轴向旋转，该抽吸管的尖端在血肿内被操纵。该项目的目标包括将可控制的针头硬件与计算机断层扫描(CT)引导相结合，使用变形模型来最大限度地减少所需的CT图像数量，并在猪模型中演示该系统的有效性。为了实现这些目标，该项目汇集了一个多学科团队，该团队结合了神经外科(Co-I Weaver)、外科器械机电设计(PI Webster)、生物力学建模(Pi Miga)、计算机科学(Co-I Burgner)、包括动物研究(Co-I Williams)和图像引导外科(所有研究人员)的专业知识。R21项目的终点将是在动物模型中成功展示完整的系统，这将为未来由R01资助的人类临床研究铺平道路。

DESCRIPTION (provided by applicant): The objective of this proposal is to design, construct, and evaluate a steerable needle to debulk intracerebral hemorrhages (ICH) less invasively, from within. This is motivated by the fact that 1 in 50 people will have an ICH in their lifetime, with 40% mortality [50] regardless of whether surgical decompression is attempted. Despite its ability to decompress at-risk tissue, one reason surgery does not produce better overall clinical outcomes may be because of the large volume of healthy brain tissue disrupted simply to access the surgical site. To provide a means of achieving decompression more safely, we propose to create a system capable of debulking the hematoma that results from an ICH without wide exposure, through a needle-sized entry path. Our new steerable needle system will debulk the hematoma from within using a superelastic, precurved aspiration cannula that is deployed within the hematoma through a straight outer needle. The tip of this aspiration cannula is maneuvered within the hematoma by coordinated linear motion and axial rotation of both needle and cannula. The aims of this project involve integrating steerable needle hardware with computed tomography (CT) guidance and use of a deformation model to minimize the number of CT images required, and a demonstration of the system's effectiveness in a porcine model. To achieve these aims, this project brings together a multidisciplinary team combining expertise in neurosurgery (Co-I Weaver), electromechanical design of surgical devices (PI Webster), biomechanical modeling (PI Miga), computer science (Co-I Burgner), surgical research including animal studies (Co-I Williams), and image-guided surgery (all investigators). The endpoint of this R21 project will be a successful demonstration of the complete system in an animal model, which will pave the way for future R01-funded human clinical studies.