Enhanced carotid bifurcation phantom for MRI/A

描述（由申请人提供）：颈动脉的无创MRI评价 动脉壁腔和血流模式受到缺乏 全面且解剖学正确的市售流动体模。的 本计画的目的是研制一种先进的人工颈动脉 用于开发MRI应用以识别患者的血流体模 短暂性脑缺血发作或中风的风险。在第一阶段， 确立了习选择第二阶段的技术目标是系统地扩大 关键技术的知识和经验基础：1）管腔设计，基于 图像数据，2）壁力学，具有区域变化，3）图像形态， 包括具有纤维帽损伤的两个不同的层和4）流体运动， 定制脉动流泵和实验结果与血流动力学比较 模拟原型的构建和评估：学术，临床 和工业环境，以衡量商业潜力，并确定关键 商业开发的功能需求。药和制剂 优化，以获得精度和稳定性的参数的顺序 18个月内增长20%。全面的血流体模将是至关重要的， 开发、验证和培训医务人员使用 用于动脉粥样硬化性颈动脉疾病的现有技术MRI筛查方案。 拟定商业应用： 临床上对无创手段的需求量很大，以识别处于风险中的患者并进行颈动脉手术，而足够的MRI工具的商业可用性很有限，因此为针对脑血管疾病的高度先进的拟人流动模型创造了有利可图的市场利基。该项目开发的产品将满足临床研究、质量保证和人员培训应用的当前和未来需求。(See产品开发计划，第45-50页）。

DESCRIPTION (provided by applicant): Non invasive MRI evaluation of the carotid artery wall lumen and blood flow patterns is hampered by the lack of a comprehensive and anatomically correct commercially available flow phantom. The objective of this project is to develop an advanced artificial carotid artery flow phantom for use in developing MRI applications to identify patients at risk for transient ischemic attack or strokes. In Phase I, proof-of-concept was established. Phase II technical aims are selected to systematically expand the knowledge and experience base of key technologies: 1) lumen design, based on image data, 2) wall mechanics, with regional variation, 3) image morphology, including two distinct layers with fibrous cap lesion and 4) fluid motion with custom pulsatile flow pump and experimental results compared to hemodynamic simulations. Prototypes are constructed and evaluated in: academic, clinical and industrial environments to gauge commercial potential and identify key functional requirements for commercial development. Materials and preparations are optimized to obtain precision and stability of parameters on the order of 20 percent over 18 months. A comprehensive flow phantom will be critical for the development, validation and training of medical personnel on using state of the art MRI screening protocols for atherosclerotic carotid artery disease. PROPOSED COMMERCIAL APPLICATION: The magnitude of the clinical need for a non invasive means to identify patients at risk and stage carotid artery surgery is so large and the commercial availability of adequate MRI tools so limited as to create a lucrative market niche for highly advanced anthropomorphic flow phantoms targeted at cerebrovascular disease. Products developed from this project will address current and future needs in clinical research, QA, and personnel training applications. (See Product Development Plan, pages 45-50).