Preclinical development of SMA artificial anal sphincters.

This article presents some progress in the development for preclinical trials of an artificial anal sphincter using shape memory alloys. The novel device has been proposed and developed by the author's group at Tohoku University. It has two dominant features different from other systems, which are either clinically available or still under development. One is that a solid driving element, a combination of shape memory alloy (SMA) ribbons and silicone elastomer sheets with a layered structure, is adopted for the opening and closing functions of the artificial sphincter. The other is a sandwich mechanism for the closing of bowel to reduce the risk of buckling induced ischemia which has been reported in hydraulically driven artificial sphincters with a radial squeezing mechanism. The device has fewer parts inside the body and therefore be implanted more easily. A new design eliminating the risk of heat burns enables long-term implantation and brings the device closer to practical use. Functionality and safety of the device have been proved in three-month animal experiments.