Real-time three-dimensional spinal navigation system for bedside lumbar puncture placement

项目摘要/摘要 在美国，每年进行的诊断性腰椎穿刺术超过45万次，但高达15%-35% 程序性失败，主要是由于无法进入鞘内间隙。床边LP失败率为 在日益增长的肥胖人口中尤为严重，最近的研究报告称， 体重指数超过35公斤/平方米的受试者。考虑到它的技术难度，人们不愿在床边进行LP，甚至 当医学上有指示的时候。因此，30%-50%的LP现在是在透视引导下进行的，但 确保神经放射学服务延迟诊断，增加成本，并且在紧急或危重护理中是不可能的。 情况。失败的LP对患者和医疗系统造成的直接和间接总成本超过 每年5亿美元。因此，床边LP显然需要达到与使用 透视，很可能是一项降低管理LP难度的技术进步 以满足这一需求。 在本项目期间，将在高质量的基础上开发基于三维超声的床边LP引导系统 管理体系(QMS)通过国际标准化组织13485：2016年和21CFR820部分认证。关键技术 支持该产品开发的创新包括：3D骨骼重建 技术支持腰椎的类似透视渲染，脊柱标志性识别算法 自动检测鞘内间隙的位置，以及帮助 针头轨迹的可视化。项目周期早期阶段的主要技术任务 包括执行最终用户临床可用性研究以指导技术规范开发、电子 核心超声机械子系统的设计、集成和验证，以及设计和实施 图像处理和可视化算法。成功完成这些技术目标将导致 在项目后期为临床前验证研究制造前期生产系统。 临床前产品验证活动将包括在以下方面进行的身体和人体成像研究 与临床专家协作，他们将验证该系统是否符合临床要求 申请。临床前身体研究的主要终点是直接比较针头 当前护理标准(盲针放置)和3D-超声波之间的放置精度 导针产品。另一项临床前研究将表征整个系统的可用性和 通过研究产品在150个模拟环境中的使用情况，学习达到系统能力所需的学习曲线 成像程序，由至少10名个人神经科医生进行。 这项研究项目的完成将导致开发和制造一种人体临床试验-- 基于Ready 3D成像的腰椎穿刺术引导系统。

PROJECT SUMMARY/ABSTRACT Over 450,000 diagnostic lumbar punctures (LPs) are performed annually in the US, but up to 15 – 35% end in procedural failure, primarily due to inability to access the intrathecal space. Bedside LP failure rates are particularly high in the growing obese population, with recent studies reporting failure rates greater than 50% in subjects over BMI 35 kg/m2. Given its technical difficulty, there is a reluctance to perform bedside LPs, even when medically indicated. Consequently, 30 – 50% of LPs are now performed under fluoroscopic guidance, but securing neuroradiology services delays diagnosis, adds cost, and is not possible in emergency or critical care situations. The total direct and indirect costs of failed LPs to patients and the healthcare system exceed $500M/yr. Thus, there is a clear need for bedside LPs to reach success rates similar to those performed using fluoroscopy, and it is likely that a technological advancement that reduces the difficulty of administering LPs is required to meet this need. During this project, a 3D ultrasound-based bedside LP guidance system will be developed under a quality management system (QMS) certified to ISO 13485:2016 and 21 CFR Part 820. The key technological innovations underpinning the development of this product include the following: 3D bone reconstruction technologies enabling ‘fluoroscopy-like’ renderings of the lumbar spine, spine landmark recognition algorithms that automatically detect the location of the intrathecal space, and needle guidance methods to aid visualization of the needle trajectory. The primary technical tasks during the early phases of the project period include the execution of end-user clinical usability studies to guide technical specification development, electro- mechanical sub-system design, integration, and validation, and design and implementation of core ultrasound imaging processing and visualization algorithms. Successful completion of these technical aims will result in fabrication of pre-production systems for pre-clinical validation studies later in the project period. Pre-clinical product validation activities will include cadaver and human-imaging studies performed in collaboration with clinical experts who will validate that the system meets the requirements for the clinical application. The primary endpoint for the pre-clinical cadaveric studies is a direct comparison of needle placement accuracy between the current standard of care (blind needle placement) and the 3D-ultrasound needle guidance product. An additional pre-clinical study will characterize overall system usability and the learning curve required to reach competency with the system by studying the product’s use in 150 simulated imaging procedures, performed by at least 10 individual neurologists. Completion of this research project will result in the development and fabrication of a human clinical-trial- ready 3D-imaging based lumbar puncture guidance system.