Development of a novel, remote-controlled artificial bowel sphincter through microsystems technology.

An artificial sphincter prototype has been developed, specifically designed for comfortable remote control by fecally incontinent patients. The artificial sphincter includes a fluid reservoir, an occlusive cuff, and a micropump based on piezo-technology in a single unit. Continence and implantation management were evaluated around isolated porcine anal canals and in vivo. The design of the prosthesis reduces the occlusion pressure and allows low inflation volumes (6.5-16 mL). Operating pressures between 24 and 58 mm Hg indicate a minor risk of ischemic injury to the bowel. The operation time is estimated at about 7 days with no recharging of the battery. The novel prototype is a highly integrated prosthesis for placement around the anal canal or lower rectum, effecting continence with comfortable control.