Thermal control of shape memory alloy artificial anal sphincters for complete implantation

This paper presents an approach for the thermal control of an artificial anal sphincter using shape memory alloys. An artificial anal sphincter has been proposed by the authors to resolve problems of severe fecal incontinence in patients. The basic design of the artificial sphincter consists of two all-round shape memory alloy plates as the main functional parts, and heaters that are attached to the SMA plates for generating the thermal cycles required for the phase transformation accompanied shape changes of the plates. The SMA artificial sphincter could be fitted around intestines, performing an occlusion function at body temperature and a release function upon heating. Thermal compatibility of such prostheses is most important and is critical for practical use. Since a temperature rise of approximately 20 °C from body temperature is needed to activate a complete transformation of SMA plates, an earlier model of ours allowed only a short period of heating, resulting in incomplete evacuation. In this work, a thermal control approach using a temperature-responsive reed switch has been incorporated into the device to prevent the SMA plates from overheating. Then, with thermal insulation the artificial anal sphincter is expected to allow a long enough opening period for fecal continence; without any thermal impact to the surrounding tissues that would be in contact with the artificial sphincter. Thermal control was confirmed in both in vitro and in vivo experiments, suggesting the effectiveness of the present approach. The modified SMA artificial anal sphincter has been implanted into animal models for chronic experiments of up to 4 weeks, and has exhibited good performance by maintaining occlusion and release functions. At autopsy, no anomaly due to thermal impact was found on the surfaces of intestines that had been in contact with the artificial anal sphincter.