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（在第一阶段），然后证明（在随后的第二阶段）一个安全，紧凑的贴片式监测设备，用于直接测量极低出生体重（VLBW，<1500 gm）婴儿的大脑血流。在第一阶段，3D多普勒技术的准确性将被评估的血管尺寸和几何形状特定的新生儿大脑，并将确定实施这些技术使用一个紧凑的基于MEMS的超声换能器模块的可行性。在第二阶段，将开发全尺寸传感器原型，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。临床市场将从这一创新中受益匪浅，因为美国每年有近64，000名VLBW婴儿出生。这些脆弱的患者中的许多人将在生命的最初几天和几周内由于异常的血液流向大脑而遭受毁灭性的脑损伤。目前，脑损伤导致5-10%的VLBW幸存者患有脑瘫，更多的人将在以后的生活中发展认知或行为异常。定期监测新生儿大脑的血流将为医生提供早期干预所需的信息，减少持续损伤的可能性。这显然将给人类带来巨大的好处，并且还将减少医疗保健支出，因为最近的估计表明每位脑瘫患者的终生护理成本将超过100万美元。 公共卫生相关性：Sonetics新型超声新生儿脑血流监测仪的成功开发对公共卫生的潜在益处包括：极低出生体重儿的存活率更高，脑瘫和新生儿脑损伤导致的其他发育问题的患病率降低，以及整个社会的医疗保健成本降低。此外，如果准确的直接血流监测得到更广泛的部署，健康结果将改善其他患者人群，如外周动脉疾病。

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.