Salivary Osmometry: A Novel Paradigm in Point-of-Care Hydration Assessment

描述(由申请人提供)：脱水在医疗保健中是一个严重且昂贵的问题。例如，文献估计，所有熟练护理机构的居民中有30%-50%患有慢性脱水，导致医疗系统每年的成本超过10亿美元。在儿科领域，据估计，全世界每年有200多万人死于脱水相关原因。目前，没有有效的手段来为有脱水风险的人提供准确、廉价、非侵入性的护理地点评估。近年来，几位研究人员已经确认唾液渗透压(唾液中颗粒的浓度)是人类水合作用的一个强有力的标志。坎蒂默公司一直在开发一种微型机电传感器技术，可以对这一特性进行快速、相对便宜、非侵入性的护理点评估。通过监测易于获取的体液，Cantimer建议为医疗保健提供者和健康消费者社区提供一种简单的工具，用于在医院、医生办公室、长期护理/辅助生活设施或家庭环境中进行持续的床边水分状况评估。该公司已经建造了许多设备原型，可以在实验室环境中准确可靠地测量唾液渗透压。这一第一阶段研究项目的目标将是开发一个能够重复测量护理点并准备进入临床试验的独立单元。该项目的工作将涉及传感器污染和污垢；微流控设计、初始产品概念开发以及设备工程的其他方面。随后的第二阶段工作和商业化计划将包括制定和启动适当的临床研究，从而将人类水合监测引入医疗保健市场。

DESCRIPTION (provided by applicant): Dehydration poses a significant and costly problem in medical care. As an example, literature estimates that 30-50% of all skilled nursing facility residents are chronically dehydrated, with resulting cost to the medical system exceeding $1 billion dollars annually. In the pediatric realm, it is estimated that over 2,000,000 deaths occur worldwide every year due to dehydration-associated causes. Currently, no effective means exist to provide accurate, inexpensive, non-invasive point-of-care evaluation of persons at risk for dehydration. In recent years, several researchers have identified salivary osmolality (the concentration of particles in saliva) as a powerful marker of human hydration. Cantimer, Inc. has been developing a microelectromechanical sensor technology that allows rapid, relatively inexpensive, non-invasive point-of-care evaluation of this property. By monitoring a readily accessible body fluid, Cantimer proposes to provide a simple tool to the healthcare provider and health consumer community for ongoing bedside assessment of hydration status in the hospital, doctor's office, long-term care/assisted living facility, or the home setting. The company has constructed a number of device prototypes, which accurately and reliably measure salivary osmolality in the laboratory setting. The goal of this Phase 1 research project would be to develop a stand-alone unit capable of repeated point-of-care measurement, and ready for entry into clinical trials. The project work would address sensor contamination and fouling; microfluidic design, initial product concept development, and other aspects of device engineering. Subsequent Phase 2 work and commercialization plan would include the formulation and initiation of appropriate clinical studies leading to the introduction of a Human Hydration Monitor into the healthcare marketplace.