Biochemical evaluation of an artificial anal sphincter made from shape memory alloys.

Severe anal incontinence is a socially incapacitating disorder and a major unresolved clinical problem that has a considerable negative impact on quality of life. In this study, we developed a new artificial anal sphincter using shape memory alloys (SMAs) in order to improve the quality of life of such patients and evaluated the influence of this sphincter on blood serum chemistry in animal experiments. The artificial anal sphincter was driven by two Ti-Ni SMA actuators sandwiching the intestine and was implanted in three female goats. Blood was collected from the jugular vein on days 1 and 4; at weeks 1 and 2; and at months 1, 2, and 3, postoperatively. Biochemical parameters including total protein, albumin, total bilirubin, aspartate amino-transferase, blood urea nitrogen, creatinine, and C-reactive protein were examined. The time courses of total bilirubin and aspartate amino transferase of the three goats were within the baseline levels after 1 week of implantation and remained normal, demonstrating no liver function complications. The blood urea nitrogen and creatinine levels remained within the normal range, indicating no renal function complications. The total protein and albumin fluctuated within the normal range throughout the duration of this study. In these goats, it was also found that the level of C-reactive protein did not increase and that there was no stricture of the intestine where the artificial sphincter was attached. Our findings indicate that the artificial sphincter SMA demonstrated no adverse influence on blood serum chemistry and exhibited an effective system performance.