Debulking From Within: A Steerable Needle for Intracerebral Hemorrhage Aspiration

从内部减灭：用于脑出血抽吸的可操纵针

• 批准号: 8829618
• 负责人: Michael Ian Miga
• 金额: $ 20.89万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-30 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8829618
• 关键词: Algorithms; Animal Model; Animals; Biomechanics; Biopsy; Blood; Body Fluids; Brain; Brain Injuries; Cannulas; Catheters; Cerebral hemisphere hemorrhage; Cerebrospinal Fluid; Clinical; Clinical Research; Coagulation Process; Devices; Diuretics; Effectiveness; Elasticity; Elements; Employee Strikes; Excision; Exploratory/Developmental Grant; Family suidae; Feedback; Funding; Future; Gelatin; Geometry; Goals; Hematoma; Hemorrhage; Human; Image; Image-Guided Surgery; Incidence; Infusion Pumps; Intervention; Intracerebral Pressures; Lead; Lesion; Location; Mechanics; Modeling; Motion; Needles; Operative Surgical Procedures; Outcome; Patient observation; Patients; Pilot Projects; Problem Solving; Procedures; Research; Research Personnel; Risk; Robot; Rotation; Safety; Scanning; Series; Severities; Site; Solid; Surgical Decompression; System; Testing; Tissue Model; Tissues; Tumor Debulking; Visit; X-Ray Computed Tomography; base; brain surgery; brain tissue; computer science; cost; design; design and construction; high reward; high risk; improved; interstitial; minimally invasive; mortality; multidisciplinary; neurosurgery; novel; novel strategies; pressure; prevent; prototype; public health relevance; research study; success; surgical research; theories

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.

描述（由申请人提供）：本提案的目的是设计、构建和评价一种可控针，以从内部微创清除脑内血肿（ICH）。这是因为每50人中就有1人在其一生中会发生ICH，无论是否尝试手术减压，死亡率均为40%[50]。尽管手术能够修复有风险的组织，但手术不能产生更好的整体临床结果的一个原因可能是因为大量健康的脑组织被破坏，只是为了进入手术部位。为了提供一种更安全地减压的方法，我们建议创建一种能够通过针大小的进入路径对ICH引起的血肿进行减积的系统，该系统通过直的外针在血肿内部署超弹性的抽吸套管，我们的新型可操纵针系统将从内部对血肿进行减积。该抽吸套管的尖端通过针和套管的协调线性运动和轴向旋转而被固定在血肿内。该项目的目的包括将可控针硬件与计算机断层扫描（CT）引导相结合，并使用变形模型来最大限度地减少所需的CT图像数量，以及在猪模型中证明系统的有效性。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）、手术器械机电设计（PI韦伯斯特）、生物力学建模（PI Miga）、计算机科学（Co-I Burgner）、包括动物研究在内的手术研究（Co-I威廉姆斯）和图像引导手术（所有研究者）的专业知识。该R21项目的终点将是在动物模型中成功演示完整系统，这将为未来R 01资助的人体临床研究铺平道路。