A Neonatal Cerebral Blood Flow Monitor based on MEMS Ultrasound

描述（由申请人提供）：拟议项目的目标是解决几个技术可行性问题（在I期），然后演示（在随后的II期）一种安全、紧凑的贴片式监测装置，用于直接测量极低出生体重（VLBW, <1500gm）婴儿的脑血流量。在第一阶段，3D多普勒技术的准确性将根据新生儿大脑的血管大小和几何形状进行评估，并确定使用紧凑型mems超声换能器模块实施这些技术的可行性。在第二阶段，将开发全尺寸换能器原型，并在动物和/或临床研究中进行演示。最后，在第三阶段，监测硬件和软件将商业化并转化为临床市场，可能与现有新生儿监测设备的制造商合作。鉴于美国每年有近64,000名VLBW婴儿出生，临床市场将从这一创新中受益匪浅。这些脆弱的病人中的许多人在出生后的头几天或几周内会遭受毁灭性的脑损伤，原因是脑部血流异常。目前，脑损伤导致5-10%的VLBW幸存者患有脑瘫，更多的人在以后的生活中会出现认知或行为异常。定期监测新生儿脑部的血流量将为医生提供早期干预所需的信息，减少持久损伤的可能性。这显然会给人类带来巨大的好处，也会减少医疗保健支出，因为最近的估计表明，每个脑瘫患者的终身护理成本将超过100万美元。

DESCRIPTION (provided by applicant): The goal of the proposed program is to address several technical feasibility questions (in Phase I), and then demonstrate (in a subsequent Phase II) a safe, compact patch-like monitoring device for directly measuring blood flow to the brain in very low birth weight (VLBW, <1500gm) infants. In Phase I, the accuracy of 3D Doppler techniques will be evaluated for the vessel sizes and geometries specific to the neonatal brain, and the feasibility will be determined for implementing these techniques using a compact MEMS-based ultrasound transducer module. In Phase II, a full-scale transducer prototype will be developed and demonstrated in animal and/or clinical studies. Finally, in Phase III the monitoring hardware and software will be commercialized and translated to the clinical market, likely in partnership with manufacturers of existing neonatal monitoring equipment. The clinical market stands to benefit greatly from this innovation, given that nearly 64,000 VLBW infants are born in the U.S. each year. Many of these fragile patients will sustain devastating brain injuries during the first days and weeks of life due to abnormal blood flow to the brain. Currently, brain injuries cause 5-10% of VLBW survivors to suffer from cerebral palsy and many more will develop cognitive or behavioral abnormalities in later life. Regular monitoring of blood flow to the neonatal brain would provide physicians the information needed to intervene early, reducing the likelihood of lasting injury. This would clearly have immense human benefit and would also reduce healthcare spending, given recent estimates that suggest the lifetime cost of care for each cerebral palsy patient will exceed $1M. PUBLIC HEALTH RELEVANCE: Potential benefits to public health from the successful development of Sonetics' novel ultrasound-based neonatal cerebral blood flow monitor include: higher survival rates for very low birth weight infants, reduced prevalence of cerebral palsy and other developmental problems resulting from neonatal brain injuries, and reduced health-care costs for society as a whole. Furthermore, if accurate direct blood flow monitoring becomes more widely deployed, health outcomes will improve for additional patient populations such as those with peripheral arterial disease.