Debulking From Within: A Steerable Needle for Intracerebral Hemorrhage Aspiration

描述（由申请人提供）：本提案的目的是设计、构建和评估一种可操纵的针头，从内部微创地清除脑出血（ICH）。这是因为每50人中就有1人在其一生中会发生脑出血，无论是否尝试手术减压，死亡率都有40%。尽管手术能够对危险组织进行减压，但手术不能产生更好的整体临床结果的一个原因可能是，仅仅为了进入手术部位，就破坏了大量健康的脑组织。为了提供一种更安全的减压方法，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减少ICH导致的血肿。我们的新导向针系统将使用超弹性、预弯曲的抽吸套管，通过直的外针在血肿内部署，从内部去除血肿。通过针和套管的协调线性运动和轴向旋转，在血肿内操作抽吸套管的尖端。该项目的目标包括将可操纵的针头硬件与计算机断层扫描（CT）引导和变形模型的使用相结合，以减少所需的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，结合了神经外科（Co-I Weaver）、外科设备机电设计（PI Webster）、生物力学建模（PI Miga）、计算机科学（Co-I Burgner）、外科研究（包括动物研究）和图像引导手术（所有研究者）的专业知识。这个R21项目的终点将是在动物模型中成功地展示完整的系统，这将为未来r01资助的人体临床研究铺平道路。

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.