SBIR-STTR Award

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 fiber optic sensor placed in an individual's undergarment, which will act like a "sniffer" and respond to gas associated with defecation. To confirm feasibility, Phase I of this project will involve analyses of fresh fecal samples from convalescent center patients using the fiber- based sensor technique. Studies will be conducted to characterize the variation in the amount and rate of liberation of the indicator gas specie. Means of improving the sensor system will also be researched, especially the design of the detector instrument, for this specific application. The Phase I work will provide key information regarding parameters critical to the design and implementation of the monitoring system for patient application. This will enable prototype systems to be developed in Phase IiI. The objective is to conduct trials in Phase II with sensor systems worn by patients. PROPOSED COMMERCIAL APPLICATIONS: This monitoring system will be used by fecal incontinent patients, and by health-care facilities having incontinent patients requiring assisted care. It will allow improved care and management of those incontinent and reduce health-care delivery costs. There are additional applications for this gas sensing technique in other biomedical applications and in general industry.

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.

Thesaurus Terms:
biomedical equipment development, biosensor, electronic recording system, fecal incontinence, human old age (65+), patient monitoring device, portable biomedical equipment clinical biomedical equipment, clinical trial, diagnosis quality /standard, disease /disorder prevention /control, health economics, optical communication, optics, patient care management, quality of life, residential care facility, skin infection, stimulus /response biotechnology, clinical research, gas analyzer