New Ultrasound Instrument for Carotid Screening

描述（由申请人提供）：该项目的目的是开发一种适用于筛选颈动脉狭窄导致卒中的仪器。在过去的十年中，研究表明，切除高度颈动脉狭窄可以将该人群的中风率降低50%以上;由于由这种狭窄引起的中风与每年120，000例中风相关，因此将这些中风减少一半以上是理想的医疗保健目标。使用多普勒信息检测高级别狭窄与双功超声已被证明具有良好的筛选灵敏度和特异性;然而，检查的高成本和对操作员/仪器的依赖，以获得满意的性能排除了中风预防颈动脉筛查。 一种新的多普勒超声方法已被设计来测量颈动脉中的血流速度，而不需要成像，并且对其操作者的依赖性最小。在第一阶段，该方法的可行性将通过一种概念验证仪器来证明，该仪器将测量血流速度，并在其操作中，其操作独立性和低成本的潜力。在阶段I中要满足的具体里程碑将是在已经安排进行这种双重检查的患者组中，血液速度测量与常规双重超声检查的血液速度测量之间的相关性> 0.9。 在第二阶段，在第一阶段证明的方法将被构建成一个原型筛选系统，与创新技术医学整合中心（MGH/Brigham & Women's/MIT/德雷珀实验室联合中心）合作，他们将设计和监督系统的筛选试验，并将塑造原型的用户界面/机器智能方面。Welch Allyn为该仪器的25，000多个初级保健中心提供服务，他将在第二阶段担任顾问，以确保其商业可行性。

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.