Automated three-dimensional spinal navigation system for chronic pain therapy

用于慢性疼痛治疗的自动化三维脊柱导航系统

• 批准号: 10384241
• 负责人: Frank William Mauldin
• 金额: $ 87.72万
• 依托单位: RIVANNA MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-20 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10384241
• 关键词: 3-Dimensional; 3D ultrasound; Ablation; Accounting; Acoustics; Adoption; Age; Algorithms; American; Anatomy; Bone Surface; Cadaver; Clinical; Clinical Trials; Collaborations; Competence; Data; Detection; Development; Facet joint structure; Fluoroscopy; Funding; Gel; Goals; Health Care Costs; Health Expenditures; Healthcare Systems; Hospitals; Human; Hydrogels; Image; Imaging technology; In Vitro; Individual; Infrastructure; Injections; International; Intervention; Interventional Ultrasonography; Intuition; Ionizing radiation; Joints; Learning; Manufacturer Name; Measurement; Mechanics; Medical Device; Medicine; Methodology; Modality; Navigation System; Needles; Nerve; Nerve Block; Pain; Pain Clinics; Pain management; Patients; Performance; Personal Satisfaction; Persons; Pharmaceutical Preparations; Phase; Physicians; Physicians' Offices; Positioning Attribute; Procedures; Production; Radiation Dose Unit; Radiation exposure; Radiology Specialty; Research Project Grants; Residencies; Sensitivity and Specificity; Services; Specimen; Spinal; Sterility; Supervision; System; Technology; Therapeutic; Three-Dimensional Imaging; Time; Training Programs; Ultrasonography; United States; Validation; Vertebral column; Visualization; Work; X-Ray Computed Tomography; associated symptom; attenuation; base; bone; chronic back pain; chronic pain; chronic pain management; chronic painful condition; clinical application; commercial application; commercialization; cost; design; digital; experience; hazard; human imaging; human subject; illicit opioid; image guided; imaging platform; imaging probe; imaging study; imaging system; improved; innovation; intervention cost; manufacturability; member; non-opioid analgesic; notch protein; opioid epidemic; opioid use; pain relief; patient population; pre-clinical; preclinical study; prescription opioid; primary endpoint; product development; prototype; radio frequency; rapid growth; reconstruction; reduce symptoms; skills; standard of care; success; technological innovation; usability; validation studies

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.

项目摘要/摘要 估计有4000万美国人患有慢性背痛，使美国经济损失> 250B美元/年。最多 慢性背部疼痛起源于方面关节，可以通过靶向关节注射，神经块， 和射频神经消融。但是，当前的护理标准依赖于荧光镜针头 在这些介入程序中的指导，导致成员之间的累积辐射剂量高 由于基础设施成本，该患者人群的限制 与执行荧光镜进行指导的程序有关。患者进入有限的结果之一 介入性疼痛程序是用于管理长期处方治疗的持续缓解 慢性疼痛状况，尽管已知危害与长期使用阿片类药物有关的患者健康危害。 在此项目中，将开发一个基于3D超声的荧光镜检查成像系统 在ISO 13485：2016和21 CFR第820部分认证的质量管理系统（QMS）下。 该产品开发的基础的技术创新包括以下内容：3D Bone 重建技术可实现脊柱的“透视样”效果 超声探针系统以支持方面关节的实时针头指导和自动可视化 治疗注射液以确认准确的药物给药。在 项目期间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施。成功的 这些技术目标的完成将导致制造前临床预生产系统 验证研究将在项目期间进行。 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，他们将验证该系统满足临床要求 应用。临床前尸体研究的主要终点是直接测量精度 通过CT成像确认，针头放置在片段关节上。此外，第二次临床前研究 使用尸体标本将表征与系统达到能力所需的学习曲线 通过研究15个个体止痛药医生在多个的精确实现的针头放置 模拟程序。 该研究项目的完成将导致人类临床审判的发展和制造 准备的3D超声图像成像系统，以支持针对介入程序的指导 方面关节。