Design and evaluation of puborectalis-like artificial anal sphincter that replicates rectal perception.

While fecal incontinence (FI) is not fatal, it can dramatically decrease the patient's quality of life. An artificial anal sphincter (AAS) is an implantable device that treats FI by replacing a diseased or damaged anal sphincter, thus allowing the patient's continence to be maintained. Here, we report a novel implantable puborectalis-like artificial anal sphincter (PAAS) that replicates rectal perception and has a low risk of ischemia necrosis. Using the pressure sensors embedded in the PAAS, the relationship between the mass of feces and the pressure was determined, and a feces mass estimation model was developed based on in vitro studies. Rectal perception is provided through the real-time monitoring of rectal feces, and the feeling of defecation is quantified based on a comparison between the feces mass and a preset threshold mass. In vivo studies were performed for validation, and the accuracy of the model was determined to be as high as 90%. The performance of the PAAS in the real-time monitoring of rectal feces and its in vivo biocompatibility were also evaluated. The device should further the functionality of existing AAS systems while improving their biosafety and thus expand the applicability of implantable AAS systems in the treatment of FI.