Measuring Intra/Extracellular Volume and Hemodynamics

描述(由申请人提供)：LDM Associates(LDM)建议完成他们的组合阻抗体积描记仪(IPG)和电阻抗频谱(EIS)仪器的开发，该仪器将允许对节段血流、细胞内、间质和血管内容量进行无创实时相对测量。该仪器将是第一个可以同时测量血流和节段性隔室体积的仪器。它也将是除了细胞内/细胞外体积之外，唯一可以用来测量间质液体体积的仪器。在第一阶段，LDM完成了四个原型单元的设计和制造，并进行了一系列初步测试，证明了我们建议的系统的可行性，并提供了完善计算机控制数据采集和分析软件所需的宝贵信息，该软件是我们仪器仪表的组成部分。在第二阶段，LDM将进一步开发和优化IPG/EIS系统，包括多段接口、床边监测配置和先进的控制/显示软件。在第二阶段，将进行一系列的动物和人体研究，以验证使用“黄金标准”隔室容量监测技术的仪器的有效性。纽约医学院和乔治华盛顿大学将进行更多的人体研究，以验证和演示使用该仪器监测终末期肾病患者在透析期间的节段性体积变化。LDM还将敲定目前关于我们仪器的知识产权保护、制造、营销和客户支持的初步安排。这种价格低廉、使用方便的设备将为治疗各种病理生理液体容量和血流动力学状态提供重要信息，例如，创伤后颅内压升高的处理，肾透析期间平衡失调和低血压的治疗，早产儿水分状态的监测，以及与自主神经功能障碍和太空飞行相关的立位不耐受的调查和诊断。

DESCRIPTION (provided by applicant): LDM Associates (LDM) proposes to complete the development of their combined impedance plethysmographic (IPG) and electrical impedance spectroscopic (EIS) instrumentation that will allow noninvasive real-time relative measurement of segmental blood flow, intracellular, interstitial, and intravascular volumes. This instrument will be the first of its kind that can measure both blood flows and segmental compartment volumes. It will also be the only instrument that can be used to measure interstitial fluid volumes in addition to intra/extracellular volumes. In Phase I, LDM completed the design and fabrication of four prototype units and conducted a series of preliminary tests that demonstrated the feasibility of our proposed system and provided valuable information that was needed to refine the computer control data acquisition and analysis software that is an integral part of our instrumentation. In Phase II, LDM will further develop and optimize an IPG/EIS system to include a multi-segment interface, a bedside monitoring configuration, and advanced control/display software. In Phase II, a series animal and human studies will be performed to validate the instrumentation using "gold standard" compartment volume monitoring techniques. Additional human studies will be performed at New York Medical College and George Washington University to verify and demonstrate the use of the instrumentation to monitor segmental volume changes of end stage renal disease patients during dialysis. LDM will also finalize current preliminary arrangements for the intellectual protection, manufacture, marketing, and customer support of our instrumentation. This inexpensive, easy to use device will provide vital information in the treatment of diverse pathophysiologic fluid volume and hemodynamic states including, for example, the management of increased intracranial pressure following trauma, the treatment of disequilibrium and hypotension during renal dialysis, the monitoring of hydration state of premature infants, and the investigation and diagnosis of orthostatic intolerance associated with dysautonomia and space flight.