Fecal-Incontinence Monitor

描述(由申请人提供)： 该项目的目标是为大便失禁患者开发一种传感器系统，以提醒个人或向他们的医护人员发送信号，通知他们大便运动和需要注意的情况。其目标是最终生产一种小型便携式电池供电的光学传感系统，可供失禁患者佩戴。该系统将使用放置在个人内衣中的一次性传感器，它的作用就像一个“嗅探器”，对与排便有关的气味做出反应。第二阶段的具体目标和研究包括：将设计和制造具有电子报告/数据记录能力的可穿戴式粪便监测系统。这些设备最初将用于在大小便失禁患者穿的内裤内主动感应，获得跟踪数据，这些数据产生关于康复护理机构中的老年人口中通常每天遇到的背景信号水平的信息。这些连续的监测数据将被用来改进传感器信号识别方案，该方案旨在定义系统的“警报触发”，以指示粪便事件。在为辨别传感器编程后，将对大小便失禁患者进行临床试验，以建立粪便监测系统的灵敏度和选择性。其他患者试验将通过长期临床交叉研究，证明粪便监测对大小便失禁患者的医疗和心理益处。减少患者接触粪便的时间是该监测仪提供的关键卫生保健益处。通过减少暴露时间，应该有直接的医疗益处，减少治疗与粪便皮肤接触相关的皮肤感染、溃疡和尿路感染的频率、严重性和相关成本。除了改善大小便失禁患者的生活质量和尊严外，监测预计还将有助于延长独立生活时间，大幅减少医疗费用支出，因为大小便失禁是导致决定进入辅助护理机构的一个主要因素。

DESCRIPTION (provided by applicant): The goal of this project is to develop a sensor system for fecal-incontinent patients to alert the individual, or send a signal to their health-care attendants, of a bowel movement and that attention is required. The objective is to ultimately produce a small portable battery operated optical| sensing system that can be worn by the incontinent patient. The system will employ a disposable sensor placed in an individual's undergarment, which will act, like a "sniffer" and respond to odor associated with defecation. Specific aims and the research of Phase II encompass the following: Wearable fecal monitoring systems with electronic reporting/data logging capability will be designed and fabricated. These will be initially used to actively sense within briefs worn by incontinent patients, obtaining tracking data yielding information about background signal level that are typically encountered day-to-day within an elderly population in a convalescent care facility. This continuous monitoring data will be used to refine sensor signal discrimination schemes designed to define the system's "alarm triggers" indicating a fecal event. After programming sensors for discrimination, clinical trials with incontinent patients will sere to establish the sensitivity and selectivity of the fecal monitoring system. Additional patient trials will demonstrate medical and psychological benefits of fecal monitoring to incontinent patients through long-term clinical crossover study. Reduction of the duration of patient exposure to fecal matter is the critical health-care benefit this monitor provides. By reducing exposure time, there should be direct medical benefits of reduced frequency, severity, and associated cost of treating fecec-skin contact related skin infections, sores, and urinary tract infections. In addition to improving the quality of life and dignity of the incontinent, monitoring is expected to help prolong independent living, with significant reduction in health-care dollars spent, because incontinence is a major factor contributing to the decision to enter an assisted care facility.