The present disclosure is a multi-functional device and method for treating
fecal incontinence and related
pelvic floor disorders. The device provides mechanical closure with or without
neuromuscular stimulation and / or
neuromodulation for individuals suffering from incontinence. The device enhances the functionality of the perianal tissue or the tissue surrounding the anal cavity, aiding in voluntary and involuntary control over continence. It comprises a flexible, multi-layer substrate with a fecal blocking element and a
buttocks support portion, which incorporates
adhesive layers and a rigid or semi-rigid support structure to ensure secure placement during use. The multi-layer substrate may be with or without a
perineum absorbent patch or pad. The device may also integrate electrodes for
transcutaneous electrical stimulation, capable of targeting the
anal sphincters or surrounding perianal tissue (including
skin, fat, and
muscle) or S2-S3 dermatomes, thereby raising the pressure in the
anal canal, contracting the external
anal sphincter, and triggering
reflex contractions. A control module may be used to activate electrical stimulation in response to user-identified urges, reinforcing voluntary
sphincter contractions. This disclosure provides a comprehensive, non-invasive solution for managing
fecal incontinence and related
pelvic floor disorders through a combination of mechanical, electrical,
drug delivery, and
irrigation therapies, offering both immediate and long- term therapeutic benefits.