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.

项目概要/摘要美国每年进行超过 450,000 次诊断性腰椎穿刺 (LP)，但高达 15 – 35% 结束手术失败的主要原因是无法进入鞘内空间。在不断增长的肥胖人群中尤其如此，最近的研究报告称，失败率超过 50% BMI 超过 35 kg/m2 的受试者鉴于其技术难度，即使是在床边也不愿意进行 LP。当医学测试表明时，30-50% 的 LPs 现在是在荧光镜引导下进行的，但是确保神经放射学服务会延误诊断、增加成本，并且在紧急或重症监护中是不可能的失败的有限合伙人给患者和医疗保健系统造成的直接和间接成本总额超过了。每年 5 亿美元因此，床边 LP 显然需要达到与使用类似方法执行的成功率。透视检查，并且降低 LP 管理难度的技术进步很可能是需要满足这种需要。在该项目期间，将在质量保证下开发基于 3D 超声的床边 LP 引导系统管理体系 (QMS) 通过 ISO 13485:2016 和 21 CFR Part 820 认证。关键技术支持该产品开发的创新包括： 3D 骨骼重建实现腰椎“类似透视”渲染的技术、脊柱识别地标算法自动检测鞘内空间的位置，以及针引导方法来帮助项目早期阶段的主要技术任务是针轨迹的可视化。包括执行最终用户临床可用性研究以指导技术规范开发、电子机械子系统设计、集成和验证，以及核心超声的设计和实现图像处理和可视化算法的成功完成将导致这些技术目标。为项目后期的临床前验证研究制造预生产系统。临床前产品验证活动将包括在以下机构进行的尸体和人体成像研究与临床专家合作，验证系统是否满足临床要求临床前尸体研究的主要终点是针的直接比较。当前护理标准（盲针放置）和 3D 超声之间的放置精度额外的临床前研究将表征整体系统的可用性和通过研究产品在 150 个模拟中的使用情况来达到系统能力所需的学习曲线成像程序由至少 10 名神经科医生执行。该研究项目的完成将导致人类临床试验的开发和制造现成的基于 3D 成像的腰椎穿刺引导系统。