Smart Seal Ostomy Appliance

DESCRIPTION (provided by applicant): Korosensor.com, Inc. (Kl) proposes to develop a wearable ostomy appliance device with a novel built-in polymer-thick-film (PTF) sensor system that alerts the ostomy user of potential leakage problems due to seal undermining and meltdown. The ability to identify leakage problems due to an ineffective seal could reduce peristomal skin breakdown. Over 1 million ostomy surgeries are performed each year. Patients undergoing ostomy surgery need intensive physical and emotional care to return to a normal life. The pressing need to provide effective skin barriers for colostomy, ileostomy and urostomy patients, achieving an effective appliance seal is critical to physical and emotional well-being as well as functional abilities of an individual with ostomies. Key factors of skin problems, skin contour, stoma construction problems and pouch leakage lead to increased supply usage, increased costs, increased hospitalizations, medical care, home health visits, and surgery revision. An ineffective seal leads to a cycle of misery for the ostomy patient. Leakage causes skin breakdown, which causes further leakage, thus perpetuating the cycle. The proposed Phase II project will focus on the development of a 10.0 mil electrochemical sensor array that can be fabricated with "sensor-on-tape" manufacturing, offering a low-cost disposable product that features a lightweight conformal fit. The body-worn ostomy appliance adapts to body contour changes, which promotes patient self-care and wellness. The smart seal device incorporates an innovative bio-alerting function to inform the ostomy patient of potential leakage to take corrective action.