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

项目概要/摘要 在美国，每年进行超过450，000次诊断性腰椎穿刺（LP），但高达15 - 35%的患者最终 手术失败，主要是由于无法进入鞘内空间。床旁LP故障率为 尤其是在不断增长的肥胖人群中，最近的研究报告失败率超过50%， BMI> 35 kg/m2的受试者。由于技术上的困难，即使是在床旁进行LP也是不情愿的， 当医学指示。因此，现在30 - 50%的LP是在荧光镜引导下进行的，但 确保神经放射学服务会延迟诊断，增加成本，并且在急诊或重症监护中不可能 situations.失败的LP对患者和医疗保健系统的直接和间接成本总额超过 5亿美元/年因此，显然需要床旁LP达到类似于使用LPs进行的成功率。 荧光镜检查，很可能是一种技术进步，降低了管理脂多糖的难度， 必须满足这一需求。 在该项目中，将在质量保证的前提下开发基于3D超声的床旁LP引导系统。 通过ISO 13485：2016和21 CFR第820部分认证的质量管理体系（QMS）。关键技术 支撑该产品开发的创新包括：3D骨重建 能够实现腰椎“透视”效果的技术，脊柱标志识别算法 自动检测鞘内空间的位置， 针轨迹的可视化。项目前期的主要技术任务 包括执行最终用户临床可用性研究，以指导技术规范开发， 机械子系统设计、集成和验证，以及核心超声的设计和实施 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预生产系统。 临床前产品确认活动将包括在 与临床专家合作，他们将验证系统是否符合临床要求 应用程序.临床前尸体研究的主要终点是直接比较针 当前护理标准（盲针放置）和3D超声之间的放置准确性 针引导产品。一项额外的临床前研究将表征整体系统可用性和 通过研究产品在150个模拟环境中的使用，达到系统能力所需的学习曲线 影像学检查，由至少10名神经科医生进行。 这项研究项目的完成将导致人类临床试验的开发和制造， 基于3D成像的腰椎穿刺引导系统。

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.