Flexible bioelectronic sensors for non-contact detection of obstruction in pediatric vascular shunts

有一个或两个心室缺陷的新生儿患者依赖于改良的Blalock-Taussig 分流（mBTS），以建立适当的全身血流。虽然这项手术挽救了许多新生儿， 对于紫绀型心脏缺陷，由于血栓和/或内膜积聚导致的mBTS阻塞， 导致高死亡率和发病率的问题。此外，护理费用也是最昂贵的。 对于任何外科手术来说都是昂贵的。 分流阻塞可导致缺氧和肺循环不足引起的猝死。 分流阻塞可能是突然的，没有足够的警告来防止患者的病情迅速恶化。 条件或者，分流阻塞也可以逐渐发生。但即使在这种情况下， 可能导致类似的不良副作用。当需要紧急干预时， 尽管进行了非常积极的复苏，但常常难以挽救分流道阻塞的婴儿。 再通可纠正分流梗阻。影像学方法不足以解决梗阻 在这些3-5 mm直径的分流器中。因此，早期发现分流阻塞至关重要， 紧急干预的必要性和可预防的生命损失。 该提案解决了对微型传感器的未满足的临床需求， 通过mBTS的血流变化需要干预。开发适合使用的流量传感器 分流术带来了一些独特的挑战，但如果成功，可以通过以下方式降低发病率和死亡率： 及时、知情的再通。 系统方法首先涉及在非接触式实验台上演示概念验证 流量传感，其次是开发分流传感器系统适用于在体内使用，然后是最后一个 在猪模型中演示有线传感器。这项工作的预期成果是演示 本发明涉及一种非接触式流量传感器，其适合与分流器一起使用以使传感器分流系统能够作为mBTS。的 成功的演示将为无线遥测技术的发展铺平道路， mBTS用于慢性动物研究。该非接触式传感方法也可应用于其它合成材料的非接触式传感 血管移植或引流分流。该提案将建立对实现以下目标至关重要的概念验证 用于家庭护理中的周期性监测的无线询问流量传感器系统的长期目标 这是一种能够早期预警的环境，以推动拯救生命的干预措施。

Neonatal patients having one or two ventricle defects are dependent on the modified Blalock-Taussig shunt (mBTS) to establish proper systemic blood flow. While the procedure has saved many newborns with cyanotic heart defects, the obstruction of mBTS due to either thrombus and/or intimal build up has been problematic leading to high mortality and morbidity. In addition, the cost of care is among the most expensive for any surgical procedure. Shunt obstruction can lead to hypoxia and sudden death due to insufficient pulmonary circulation. Shunt occlusion can be sudden and without enough warning to prevent rapid deterioration of the patient’s condition. Alternatively, shunt obstruction can also occur gradually. But even in this case, the narrowing of the shunt lumen may result in similar adverse side effects. When emergency intervention is required, despite very aggressive resuscitation, it is frequently difficult to save infants with shunt obstruction. Recanalization can correct shunt obstruction. Imaging methods are inadequate to resolve obstruction within these 3-5 mm diameter shunts. Therefore, early detection of shunt obstruction is critical to avoid the need for emergency intervention and preventable loss of life. This proposal addresses the unmet clinical need for miniature sensors that can detect significant changes in blood flow through mBTS necessitating intervention. Developing flow sensors suitable for use with shunts poses several unique challenges but if successful, can reduce morbidity and mortality through timely, informed recanalization. The systematic approach involves first demonstrating proof-of-concept at the benchtop of non-contact flow sensing, followed by developing shunt sensor systems suitable for in vivo use, and then a final demonstration of wired sensors in a pig model. The expected outcome of this work is the demonstration of a non-contact flow sensor suitable for use with shunts to enable a sensor-shunt system as mBTS. The successful demonstration will pave the way for development of a wireless telemetry to enable a wireless mBTS for chronic animal studies. The non-contact sensing method also can be applied to other synthetic vascular grafts or drainage shunts. This proposal will establish proof-of-concept that is critical to achieve the long term goal of a wirelessly interrogated flow sensor system for periodic monitoring in a home care setting that enables early warning to drive intervention that saves lives.