Development of an implantable artificial anal sphincter by the use of the shape memory alloy.

In this study, we developed and assessed an artificial anal sphincter driven by an shape memory alloy actuator (AS-SMA). The performance characteristics of the device were analyzed with a measurement system. Assessment showed that the AS-SMA could generate a pressure of 55 mm Hg at an atmospheric temperature of 36 degrees C, and displacement of the SMA actuator was 7.5 mm when the temperature of the SMA plate was 55 degrees C. To evaluate opening and closing, we studied a piglet colostomy model, in which the AS-SMA was implanted around the colostomy in the extraperitoneal space. Flow control tests using living porcine intestine revealed that the AS-SMA could maintain fecal continence against an intestinal pressure of 75 mm Hg. The high pressure zone corresponding to the location of the device was demonstrated in a manometric examination. For 6 days after surgery, we activated the AS-SMA twice a day and observed the bowel movements. The animal experiment indicated that the AS-SMA is able to control the bowel movements of patients with fecal incontinence if several problems, such as burning of tissue around the device and compression injury of the intestine, are resolved.