RFID based Wireless System for Self-powered Implantable Pediatric Cardiac Sensors

 描述（由申请人提供）：先天性心脏缺陷（CHD）仍然是最常见的主要出生缺陷类型，并且是出生后第一年内出生缺陷死亡的头号原因。其中近40%需要一次或多次手术干预，仅在美国每年就有超过20，000例手术。在手术期间和手术后，常规使用心内导管监测生理参数，例如心内压、氧合、温度、pH和乳酸水平，这些参数可能会迅速变化，并可能需要立即干预。虽然经胸插入的导管（如Swan-Ganz导管）在成人中非常宝贵，但由于尺寸限制和血栓形成风险，经胸心内导管已成为新生儿和儿科人群的标准实践。尽管这些心内导管的重要性和益处，但其维护和移除会给患者带来风险。当前心内管路技术的三大风险是：1）由于导管经皮通过和与非无菌环境连通而引起的感染; 2）维持导管腔通畅性和外部重复操作所固有的栓塞和药物暴露风险; 3）导管撤回导致的出血风险。心脏压塞和潜在的致命心脏骤停显然是最可怕的和令人沮丧的并发症后，心内导管取出。迫切需要开发一种新技术，允许直接进行生理性心内监测，在监测期间几乎没有出血和感染风险。我们建议开发基于射频识别（RFID）的无线传感系统，用于自供电植入式传感器，以确定儿童先天性心脏手术期间和之后的心内压力。我们未来的建议将集中在氧气，pH值和其他传感技术。我们的研究计划包括三个主要步骤：（i）设计和制作小型化无线植入式超薄和高弹性聚氨酯膜生物MEMS压力传感器，（ii）设计和实现基于RFID的自我维持植入式传感器无线传感系统，包括：开发高性能小型化植入式天线;开发高效的功率收集和功能控制电路;开发低功耗传感器接口;传感系统的集成;以及（iii）通过动物研究表征植入式器械。在设计驱动的同时，这项研究将回答许多基本的，以前没有测试过的问题，沿着传感器的发展路径。通过应用新颖的和高灵敏度的压力传感器设计与无电池的概念，一个功能，小型化，集成的传感设备将准备在这个项目中的动物测试。该项目的实施将使患者直接受益， 冠心病

 DESCRIPTION (provided by applicant): Congenital heart defects (CHDs) remain the most common type of major birth defects and are the number one cause of death from birth defects during the first year of life. Nearly 40% of them will require one or multiple surgical interventios and accounts for more than 20,000 yearly surgical procedures performed in US alone. During and after surgery, intra-cardiac catheters are used routinely to monitor physiologic parameters, such as intra-cardiac pressure, oxygenation, temperature, pH and lactic acid level, which can change rapidly and may require immediate intervention. While percutaneously inserted catheters, such as Swan-Ganz catheters, have been invaluable in adults, because of size limitation and risks of thrombosis, transthoracic intracardiac catheters have been the standard practice in the neonatal and pediatric populations. Despite the importance and benefits of these intracardiac lines, their maintenance and removal impose risks to the patient. Three major risks for current intra-cardiac line technology are: 1) infection, due to transcutaneous passage of the catheter and communication with unsterile environment; 2) embolization and drug exposure risks inherent in maintaining catheter lumen patency and external repeated manipulations; and 3) bleeding risks from catheter withdrawal. Cardiac tamponade and potential lethal cardiac arrest are clearly the most dreaded and frustrating complications following intracardiac catheter removal. There is a critical need in developing a new technology that allows direct physiologic intracardiac monitoring that carries little or no bleeding and infection risks during the monitorin. We propose to develop Radio-Frequency IDentification (RFID) based wireless sensing system for self-powered implantable sensors determining intracardiac pressure during and after congenital cardiac surgical procedures in children. Our future proposals will focus on oxygen, pH and other sensing technologies. Our research plan includes three major steps: (i) Design and fabrication of miniaturized wireless implantable ultra-thin and highly elastic polyurethane membrane based bioMEMS pressure sensor, (ii) Design and implementation of RFID base wireless sensing system for self-sustainable implanted sensors including: Develop high performance miniaturized implantable antenna; Develop an efficient power scavenging and function control circuits; Develop a low power sensor interface; Integration of sensing system, and (iii) Characterization of the implantable devices through animal studies. While being design-driven, this investigation will answer many fundamental, previously untested questions along the sensor developmental path. By applying novel and highly sensitive pressure sensor design with battery-free concept, a functional, miniaturized, and integrated sensing device will be ready for animal testing during this project. Fulfillment of this project will directly benefit patients with CHD.