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

基本信息

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
项目类别：
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&apos 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

项目摘要

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.

项目概要/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的损失超过 250B 美元。慢性背痛起源于小关节，可以通过有针对性的关节注射、神经阻滞、然而，目前的护理标准依赖于荧光镜针。这些介入手术期间的指导，导致成员中累积辐射剂量较高该患者群体的数量，并且由于基础设施成本限制患者接受这些程序与执行荧光镜引导手术相关的结果之一是患者接触机会有限。介入性疼痛手术是持续依赖长期处方阿片类药物治疗来控制疼痛尽管长期使用阿片类药物对患者健康存在已知危害，但慢性疼痛状况仍然存在。在该项目期间，将开发基于 3D 超声的透视替代成像系统根据 ISO 13485:2016 和 21 CFR Part 820 认证的质量管理体系 (QMS)。支持该产品开发的技术创新包括： 3D 骨骼重建技术可实现脊柱的“类似透视”渲染，这是一种特定于应用程序的 3D 超声探头系统支持对小关节的实时针引导和自动可视化确定治疗注射液的准确给药过程中的主要技术任务。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。完成这些技术目标将导致制造用于临床前的预生产系统验证研究将在项目后期进行。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应用临床前尸体研究的主要终点是准确性的直接测量。另外，第二项临床前研究还通过 CT 成像证实了针头放置在小关节上的情况。使用尸体标本将描述达到系统能力所需的学习曲线通过研究 15 名疼痛医学医师在多个领域实现的针放置准确度模拟程序。该研究项目的完成将导致人类临床试验的开发和制造准备就绪的基于 3D 超声的成像系统，支持介入手术靶向指导小关节。