UNHEATED TRANSCUTANEOUS PCO2 SENSOR FOR NEONATES

该计划的总体目标是开发一种安全可靠、非 有创性经皮二氧化碳分压传感器用于跟踪新生儿动脉二氧化碳分压 工作温度为37-38摄氏度这样的设备将提供 通过消除不利因素显著改善新生儿护理 用于经皮应用的商用二氧化碳传感器 必须加热到42-44摄氏度，会导致新生儿烧伤， 作为预防措施，必须经常移动。 在第一阶段计划中，Giner，Inc.血气传感器成功 使用固体聚合物转化为二维盘构型 电解质质子交换膜(PEM)作为固定化材料的研究 电解液和传感电极的支撑结构。更多 十几个这样的传感器被成功地制造出来，并被封装在 简单的外壳，便于使用。体外试验清楚 证明了这样的传感器可以表现出准确的线性响应 生理内外二氧化碳分压的变化 射程。 根据这些结果，拟议的第二阶段研究将集中于 改进传感器设计，以解决 第一阶段研究，随后对新生儿进行概念验证测试。这个 第二阶段计划的两个主要目标是制造一种气体传感器 快速、准确、线性地响应CO、分压和 演示安全可靠的经皮动脉二氧化碳追踪 新生儿体内的摄氏37-38度。 建议的商业应用：一种可靠的、非侵入性的二氧化碳传感器 在37摄氏度下运行，预计将有大量的商业 在新生儿护理中的应用，并可能被证明适用于 血气监测在术后恢复中的作用及对患者的影响 慢性阻塞性肺病。

The overall goal of this program is to develop a safe and reliable, non- invasive, transcutaneous pCO2 sensor to track arterial CO2 in neonates at an operating temperature of 37-38 degrees C. Such a device would offer a significant improvement in neonatal care by eliminating the disadvantages of commercially available CO2 sensors for transcutaneous application which have to be heated to 42-44 degrees C, can cause burns in neonates, and as a precaution, have to be frequently moved. In the Phase I program, the Giner, Inc. blood-gas sensor was successfully translated to a 2-dimensional disk configuration using a solid polymer electrolyte proton exchange membrane (PEM) as both the immobilized electrolyte and the supporting structure for the sensing electrodes. More than a dozen of such sensors were fabricated successfully and packaged in a simple enclosure suitable for easy use. The in vitro testing clearly demonstrated that such sensors can exhibit an accurate, linear response to changes in CO2 partial pressure within and beyond the physiologic range. Based on these results, the proposed Phase II study will focus on the improvement of the sensor design to address the issues identified in the Phase I study, followed by proof-of-concept testing with neonates. The two central goals of the Phase II program are to fabricate a gas sensor with a fast, accurate, linear response to CO, partial pressure, and to demonstrate safe and reliable transcutaneous tracking of arterial CO2 levels at 37-38 degrees C in neonates. PROPOSED COMMERCIAL APPLICATION: A reliable, non-invasive pCO2 sensor that operates at 37 degrees C is expected to have substantial commercial application in neonatal care and may prove to be applicable, also, for blood-gas monitoring in post-operative recovery and for patients with chronic obstructive lung disease.