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

床边腰椎穿刺置入实时三维脊柱导航系统

基本信息

批准号：
10689113
负责人：
Frank William Mauldin
金额：
$ 83.78万
依托单位：
RIVANNA MEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-15 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10689113
关键词：
3-Dimensional 3D ultrasound Acute Adoption Algorithms Ambulatory Care Facilities Anatomy Body mass index Cadaver Cerebrospinal Fluid Certification Clinical Collaborations Competence Critical Care Data Detection Development Diagnosis Diagnostic Direct Costs Educational process of instructing Emergency Care Exhibits Facilities and Administrative Costs Failure Feedback Fluoroscopy Funding Goals Growth Health Care Costs Healthcare Systems Hospitals Human Image Image Analysis Imaging Techniques Imaging technology Individual Inflammatory International Intrathecal Space Intuition Learning Location Manufacturer Marketing Mechanics Medical Medical Device Methods Modality Motion Navigation System Needles Neurodegenerative Disorders Neurologist Neurology Obesity Patient-Focused Outcomes Patients Phase Physicians Positioning Attribute Procedures Production Radiology Specialty Real-Time Systems Reporting Research Project Grants Residencies Resources Risk Sampling Secure Sensitivity and Specificity Services Site Specific qualifier value Specimen Spinal Spinal Puncture Sterility Subarachnoid Space System Techniques Technology Three-Dimensional Imaging Time Training Training Programs Ultrasonography Validation Vertebral column Visualization Work aging population arm automated algorithm blind bone imaging bone reconstruction clinical application clinical trial readiness commercial application commercialization cost design disease diagnosis efficacy evaluation fabrication human imaging image guided image processing image visualization imaging platform imaging probe imaging study imaging system improved in vivo obese patients obese person patient population pre-clinical preclinical development preclinical study primary endpoint product development reconstruction skills standard of care stem success technological innovation ultrasound usability validation studies

项目摘要

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.

项目摘要/摘要每年在美国进行超过450,000次诊断腰穿点（LP），但最多可达15％至35％在程序故障中，由于无法访问鞘内空间而导致的主要原因。床头LP故障率为在日益增长的肥胖人群中尤其高，最近的研究报告失败率大于50％ BMI 35千克/m2的受试者。鉴于其技术困难，甚至不愿执行床头LP，甚至当医学指示时。因此，现在有30-50％的LP在荧光镜指导下进行，但确保神经放射学服务延迟诊断，增加成本，并且在紧急或重症监护中不可能情况。 LP失败的患者的直接和间接成本超过了医疗保健系统 5亿美元/年。那很明显需要Bedside LP达到与使用的成功率相似的成功率荧光镜，很可能会减少管理LP的困难的技术进步是需要满足这种需求。在此项目期间，将在质量下开发一个基于3D超声的床头LP指导系统 ISO 13485：2016和21 CFR第820部分的管理系统（QMS）。关键技术该产品开发的基础的创新包括以下内容：3D骨重建腰椎，脊柱地标识别算法的“类似透视镜检查”效果的技术这会自动检测鞘内空间的位置以及针头引导方法以帮助针轨迹的可视化。项目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 - 机械子系统的设计，集成和验证以及核心超声的设计和实施成像处理和可视化算法。这些技术目标的成功完成将导致在项目期间晚些时候制造用于临床前验证研究的预生产系统。临床前产品验证活动将包括尸体和人类成像研究与临床专家的合作，他们将验证该系统符合临床要求应用。临床前尸体研究的主要终点是直接比较针头当前护理标准（盲针）和3D拆卸之间的放置精度针引导产品。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个模拟中的使用来实现与系统的能力所需的学习曲线成像程序，由至少10位单个神经科医生进行。该研究项目的完成将导致人类临床审判的发展和制造基于3D成像的腰椎穿刺指导系统。