New Ultrasound Instrument for Carotid Screening

描述(由申请人提供)：该项目的目标是开发一种适合于筛查颈动脉狭窄导致中风的仪器。在过去的十年中，研究表明，移除高级别颈动脉狭窄可以将该人群的中风发生率降低50%以上；由于此类狭窄导致的中风每年与12万中风有关，因此将这些中风减少一半以上是一个理想的医疗保健目标。双功超声利用多普勒信息检测重度狭窄具有良好的筛查敏感性和特异度；然而，高昂的检查成本和对操作员/仪器的依赖阻碍了预防中风的颈动脉筛查。 设计了一种新的多普勒超声方法，可以在不需要成像的情况下测量颈动脉的血流速度，并且对操作员的依赖性最小。在第一阶段，这种方法的可行性将通过一种将测量血流速度的概念验证仪器进行验证，并在其操作中证明其独立于操作员和低成本的潜力。在第一阶段要达到的具体里程碑将是在已经安排进行这种双重检查的一组患者中，血流速度测量与常规双工超声检查的结果之间的相关性。 在第二阶段，第一阶段验证的方法将与创新技术医学集成中心(MGH/Brigham&Women/MIT/Draper Lab联合中心)合作建立一个原型筛查系统，该中心将设计和监督该系统的筛查试验，并将塑造原型的用户界面/机器智能方面。为25,000多个初级保健中心提供服务的韦尔奇·阿林将在第二阶段担任顾问，以确保该工具的商业可行性。

DESCRIPTION (provided by applicant): The aim of this program is to develop an instrument suitable for screening the carotid artery for stenoses that lead to stroke. In the last decade it was shown that removal of high grade carotid stenoses could reduce the stroke rate in that population by more than 50%; as strokes caused by such stenoses are associated with 120,000 strokes per year, reducing these strokes by more than half is a desirable health care objective. Using Doppler information to detect high-grade stenosis with duplex ultrasound has been shown to have excellent screening sensitivity and specificity; however, the high cost of examination and the dependence on the operator/instrument for satisfactory performance has precluded stroke-preventing carotid screening. A new Doppler ultrasound method has been devised to measure blood velocity in the carotids without the need for imaging and with minimal dependence on its operator. In Phase I, the feasability of this method is to be demonstrated with a proof-of-concept instrument that will measure blood velocity and in its operation, its potential for operator-independence and low cost. The specific Milestone to be met in Phase I will be correlation of > .9 between the blood velocitiesit measures and those of a conventional duplex ultrasound examination in a group of patients already scheduled for such a duplex examination. In Phase II, the method proven in Phase I will be built into a prototype screening system, in collaboration the Center for Integration in Medicine of Innovative Technology (a MGH/Brigham & Women's/MIT/Draper Lab joint center) who will design and supervise the screening trials for the system and will shape the user interface/machine intelligence aspects of the prototype. Welch Allyn, who serves the 25,000+ primary care centers for whom this instrument is intended, will serve as an advisor in Phase II to ensure its path to commercial viability.