Liu Hongjian, Luo Yun, Higa Masaru, Zhang Xiumin, Saijo Yoshifumi, Shiraishi Yasuyuki, Sekine Kazumitsu, Yambe Tomoyuki
Department of Medical Engineering and Cardiology, Institute of Development, Aging and Cancer, Tohoku University, 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan.
J Artif Organs. 2007;10(4):223-7. doi: 10.1007/s10047-007-0395-y. Epub 2007 Dec 20.
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.
重度肛门失禁是一种使人丧失社交能力的疾病，也是一个尚未解决的主要临床问题，对生活质量有相当大的负面影响。在本研究中，我们开发了一种使用形状记忆合金（SMA）的新型人工肛门括约肌，以提高此类患者的生活质量，并在动物实验中评估了该括约肌对血清化学的影响。人工肛门括约肌由夹着肠道的两个钛镍形状记忆合金致动器驱动，并植入三只雌性山羊体内。术后第1天和第4天、第1周和第2周、第1个月、第2个月和第3个月从颈静脉采集血液。检测了包括总蛋白、白蛋白、总胆红素、天冬氨酸转氨酶、血尿素氮、肌酐和C反应蛋白在内的生化参数。三只山羊的总胆红素和天冬氨酸转氨酶的时间进程在植入1周后处于基线水平以内，并保持正常，表明没有肝功能并发症。血尿素氮和肌酐水平保持在正常范围内，表明没有肾功能并发症。在本研究期间，总蛋白和白蛋白在正常范围内波动。在这些山羊中，还发现C反应蛋白水平没有升高，且人工括约肌附着处的肠道没有狭窄。我们的研究结果表明，人工括约肌形状记忆合金对血清化学没有不良影响，并表现出有效的系统性能。
