Automated three-dimensional spinal navigation system for chronic pain therapy

项目摘要/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2500亿美元的损失。多数 慢性背痛起源于小关节，可通过关节靶向注射、神经阻滞、 以及射频神经消融术。然而，目前的护理标准依赖于透视针头 在这些介入过程中的指导，导致成员中的累积辐射剂量较高 由于基础设施成本的原因，限制了患者使用这些程序 与实施透视引导的手术有关。一个结果是患者接触有限的 介入性疼痛程序是对长期处方阿片类药物治疗的持续依赖 慢性疼痛状况，尽管已知长期使用阿片类药物会对患者的健康造成危害。 在这个项目中，将开发一种基于三维超声的透视替代成像系统 根据ISO 13485：2016年和21CFR Part 820认证的质量管理体系(QMS)。钥匙 支持该产品开发的技术创新包括：3D骨骼 重建技术能够实现脊柱的类似透视的渲染，这是一种特定于应用的3D 超声探头系统，支持对小关节的实时针导引，以及自动化可视化 治疗性注射剂以确认药物的准确给药。期间的主要技术任务 项目期的早期阶段包括执行最终用户临床可用性研究，以指导 核心超声可视化算法的技术规范开发和实现。成功 这些技术目标的完成将导致临床前生产系统的制造 将在项目后期进行的验证研究。 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对准确性的直接测量 CT影像所证实的小关节置针的可能性。此外，第二项临床前研究 使用身体标本将表征达到系统能力所需的学习曲线 通过研究15名个体止痛药医生在多个 模拟程序。 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超声成像的成像系统支持介入治疗靶向指导 小平面关节。

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.