Automated three-dimensional spinal navigation system for chronic pain therapy

项目总结/摘要 据估计，有4000万美国人患有慢性背痛，每年给美国经济造成的损失超过2500亿美元。最 慢性背痛起源于小关节，可以通过靶向关节注射，神经阻滞， 和射频神经消融术然而，目前的护理标准依赖于荧光针 在这些介入手术过程中的指导，导致成员之间的高累积辐射剂量 由于基础设施成本的原因， 与执行荧光透视引导程序相关。一个结果是患者接触受限， 介入性疼痛手术是持续依赖长期处方阿片类药物治疗来管理 慢性疼痛状况，尽管已知与长期使用阿片类药物相关的患者健康危害。 在该项目中，将开发一种基于3D超声的荧光透视替代成像系统 根据ISO 13485：2016和21 CFR第820部分认证的质量管理体系（QMS）。关键 支持该产品开发的技术创新包括以下内容：3D骨 重建技术实现了脊柱的“透视”效果， 超声探头系统，以支持对小关节的实时针引导和自动可视化 以确认药物的准确施用。主要技术任务 项目早期阶段包括执行最终用户临床可用性研究， 核心超声可视化算法的技术规范开发和实施。成功 这些技术目标的完成将导致制造用于临床前的预生产系统， 验证研究将在项目期间后期进行。 临床前产品确认活动将包括在 与临床专家合作，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测量准确性 CT成像证实，针放置到小关节。此外，第二项临床前研究 使用尸体样本将表征达到系统能力所需的学习曲线 通过研究15名疼痛医学医生在多个国家/地区实现的针头放置准确性， 模拟程序。 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超声成像的现成成像系统，用于支持介入手术靶向引导 小关节

PROJECT SUMMARY/ABSTRACT An estimated 40 million Americans suffer from chronic back pain, costing the US economy >$250B/yr. Most chronic back pain originates in the facet joints, and can be treated by targeted joint injections, nerve blocks, and radiofrequency nerve ablation. However, the current standard of care relies on fluoroscopic needle guidance during these interventional procedures, leading to high cumulative radiation doses among members of this patient population, and limiting patient access to these procedures due to the infrastructure costs associated with performing fluoroscopically guided procedures. One result of limited patient access to interventional pain procedures is the ongoing reliance on long-term prescription opioid treatment for managing chronic pain conditions, despite the known hazards to patient wellbeing associated with prolonged opioid use. During this project, a 3D ultrasound-based, fluoroscopy-replacement imaging 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 spine, an application-specific 3D ultrasound probe system to support real-time needle guidance to the facet joints, and automated visualization of the therapeutic injectate to confirm accurate administration of the drug. The primary technical tasks during the early stages of the project period include the execution of end-user clinical usability studies to guide technical specification development and implementation of core ultrasound visualization algorithms. Successful completion of these technical aims will result in the fabrication of pre-production systems for pre-clinical validation studies that will be conducted 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 verify that the system meets the requirements for the clinical application. The primary endpoint for the pre-clinical cadaveric studies is a direct measurement of the accuracy of needle placement to the facet joints, as confirmed by CT imaging. Additionally, a second pre-clinical study using cadaveric specimens will characterize the learning curve required to reach competency with the system by studying the needle placement accuracy achieved by 15 individual pain medicine physicians across multiple simulated procedures. Completion of this research project will result in the development and fabrication of a human clinical-trial- ready 3D ultrasound-imaging-based imaging system to support guidance of interventional procedures targeting the facet joints.