UNHEATED TRANSCUTANEOUS PCO2 SENSOR FOR NEONATES

适用于新生儿的未加热经皮 PCO2 传感器

• 批准号: 2403233
• 负责人: LARRY L SWETTE
• 金额: $ 39.39万
• 依托单位: GINER, INC.
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-09-30 至 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2403233
• 关键词: biomedical equipment development; carbon dioxide; carbon dioxide tension; clinical research; human subject; newborn human (0-6 weeks); pediatrics; respiratory gas analyzer

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.

该计划的总体目标是开发一种安全可靠、非 有创性经皮pCO 2传感器用于追踪新生儿动脉CO2 工作温度为37-38摄氏度。这样的设备将提供一个 通过消除不利因素，显著改善新生儿护理 用于经皮应用的市售CO2传感器 必须加热到42-44摄氏度，可能导致新生儿烧伤， 作为预防措施，必须经常移动。 在第一阶段计划中，Giner，Inc.成功研制了血气传感器 使用固体聚合物将其转化为二维圆盘结构 电解质质子交换膜（PEM）作为固定化 电解质和用于感测电极的支撑结构。更 成功制造并包装了十几个这样的传感器 一个简单的外壳，易于使用。 体外试验清楚地表明 证明了这种传感器可以表现出准确的线性响应 二氧化碳分压的变化， 范围 根据这些结果，拟议的II期研究将侧重于 改进传感器设计，以解决 I期研究，随后进行新生儿概念验证试验。 的 第二阶段计划的两个主要目标是制造一种气体传感器 具有快速、准确、线性的CO、分压响应， 证明动脉二氧化碳的经皮追踪安全可靠 新生儿在37-38摄氏度的水平。 拟议的商业应用：一种可靠的非侵入性pCO 2传感器 预计在37摄氏度下运行， 在新生儿护理中的应用，并可能被证明适用于，也， 术后恢复期血气监测， 慢性阻塞性肺病