Abstract: Fecal incontinence is an unresolved problem, which has a serious effect on patients, both physically and psychologically. For patients with severe symptoms, treatment with an artificial anal sphincter could be a potential option to restore continence. Currently, the Acticon Neosphincter is the only device certified by the US Food and Drug Administration. In this paper, the clinical safety and efficacy of the Acticon Neosphincter are evaluated and discussed. Furthermore, some other key studies on artificial anal sphincters are presented and summarized. In particular, this paper highlights that the crucial problem in this technology is to maintain long-term biomechanical compatibility between implants and surrounding tissues. Compatibility is affected by changes in both the morphology and mechanical properties of the tissues surrounding the implants. A new approach for enhancing the long-term biomechanical compatibility of implantable artificial sphincters is proposed based on the use of smart materials.

人工肛门括约肌临床应用所面临的挑战

[1]Altomare, D., Dodi, G., La Torre, F., et al., 2001. Multicentre retrospective analysis of the outcome of artificial anal sphincter implantation for severe faecal incontinence. Br. J. Surg., 88(11):1481-1486.

[2]Altomare, D., Binda, G., Dodi, G., et al., 2004. Disappointing long-term results of the artificial anal sphincter for faecal incontinence. Br. J. Surg., 91(10):1352-1353.

[3]AMS (American Medical Systems), 1999. Important information for patients considering an Acticon™ Neosphincter. Available from http://www.fda.gov/ohrms/dockets/ac/01/briefing/3777b1_02_patient%20info.pdf [Accessed on Mar. 23, 2014].

[4]Baig, M., Wexner, S., 2000. Factors predictive of outcome after surgery for faecal incontinence. Br. J. Surg., 87(10):1316-1330.

[5]Casal, E., San Ildefonso, A., Carracedo, R., et al., 2004. Artificial bowel sphincter in severe anal incontinence. Colorectal Dis., 6(3):180-184.

[6]Chittawatanarat, K., Koh, D.C., Seah, A.A., et al., 2010. Artificial bowel sphincter implantation for faecal incontinence in Asian patients. Asian J. Surg., 33(3):134-142.

[7]Christiansen, J., 2000. The artificial anal sphincter. Can. J. Gastroenterol., 14:152D-154D.

[8]Christiansen, J., Lorentzen, M., 1987. Implantation of artificial sphincter for anal incontinence. Lancet, 330(8553):244-245.

[9]Christiansen, J., Rasmussen, O., Lindorff-Larsen, K., 1999. Long-term results of artificial anal sphincter implantation for severe anal incontinence. Ann. Surg., 230(1):45-48.

[10]Devesa, J.M., Rey, A., Hervas, P.L., et al., 2002. Artificial anal sphincter. Dis. Colon Rectum, 45(9):1154-1163.

[11]Dodi, G., Melega, E., Masin, A., et al., 2000. Artificial bowel sphincter (ABS) for severe faecal incontinence: a clinical and manometric study. Colorectal Dis., 2(4):207-211.

[12]Doll, A., Heinrichs, M., Goldschmidtboeing, F., et al., 2006. A high performance bidirectional micropump for a novel artificial sphincter system. Sensor. Actuat. A-Phys., 130-131:445-453.

[13]Doll, A.F., Wischke, M., Geipel, A., et al., 2007. A novel artificial sphincter prosthesis driven by a four-membrane silicon micropump. Sensor. Actuat. A-Phys., 139(1-2):203-209.

[14]Finlay, I., Richardson, W., Hajivassiliou, C.A., 2004. Outcome after implantation of a novel prosthetic anal sphincter in humans. Br. J. Surg., 91(11):1485-1492.

[15]Gallas, S., Leroi, A.M., Bridoux, V., et al., 2009. Constipation in 44 patients implanted with an artificial bowel sphincter. Int. J. Colorectal Dis., 24(8):969-974.

[16]Gregorcyk, S.G., 2005. The current status of the Acticon^® Neosphincter. Clin. Colon Rectal Surg., 18(1):32-37.

[17]Jorge, J.M.N., Wexner, S.D., 1993. Etiology and management of fecal incontinence. Dis. Colon Rectum, 36(1):77-97.

[18]Kaiser, A.M., Orangio, G.R., Zutshi, M., et al., 2014. Current status: new technologies for the treatment of patients with fecal incontinence. Surg. Endosc., 28(8):2277-2301.

[19]Ke, L., Yan, G.Z., Yan, S., et al., 2014a. Coupling analysis of transcutaneous energy transfer coils with planar sandwich structure for a novel artificial anal sphincter. J. Zhejiang Univ.-Sci. C (Comput. & Electron.), 15(11):1021-1034.

[20]Ke, L., Yan, G.Z., Liu, H., et al., 2014b. A novel artificial anal sphincter system in an in vitro and in vivo experiment. Int. J. Artif. Organs, 37(3):253-263.

[21]Lehur, P.A., Michot, P.F., Denis, P., et al., 1996. Results of artificial sphincter in severe anal incontinence. Dis. Colon Rectum, 39(12):1352-1355.

[22]Lehur, P.A., Glemain, P., des Varannes, S.B., et al., 1998. Outcome of patients with an implanted artificial anal sphincter for severe faecal incontinence. A single institution report. Int. J. Colorectal Dis., 13(2):88-92.

[23]Lehur, P.A., Roig, J.V., Duinslaeger, M., 2000. Artificial anal sphincter. Dis. Colon Rectum, 43(8):1100-1106.

[24]Lehur, P.A., Zerbib, F., Neunlist, M., et al., 2002. Comparison of quality of life and anorectal function after artificial sphincter implantation. Dis. Colon Rectum, 45(4):508-513.

[25]Liu, H., Luo, Y., Higa, M., et al., 2007. Biochemical evaluation of an artificial anal sphincter made from shape memory alloys. J. Artif. Organs, 10(4):223-227.

[26]Luo, Y., Takagi, T., Okuyama, T., et al., 2004. Functional evaluation of an artificial anal sphincter using shape memory alloys. ASAIO J., 50(4):338-343.

[27]Luo, Y., Higa, M., Amae, S., et al., 2006. Preclinical development of SMA artificial anal sphincters. Minim. Invasive Ther. Allied Technol., 15(4):241-245.

[28]Lustman, P.J., Clouse, R.E., Griffith, L.S., et al., 1997. Screening for depression in diabetes using the beck depression inventory. Psychosom. Med., 59(1):24-31.

[29]Madoff, R.D., Parker, S.C., Varma, M.G., 2004. Faecal incontinence in adults. Lancet, 364(9434):621-632.

[30]Malouf, A.J., Vaizey, C.J., Kamm, M.A., 2000. Reassessing artificial bowel sphincters. Lancet, 355(9222):2219-2220.

[31]Meurette, G., la Torre, M., Regenet, N., et al., 2009. Value of sacral nerve stimulation in the treatment of severe faecal incontinence: a comparison to the artificial bowel sphincter. Colorectal Dis., 11(6):631-635.

[32]Michot, F., Costaglioli, B., Leroi, A.M., 2003. Artificial anal sphincter in severe fecal incontinence: outcome of prospective experience with 37 patients in one institution. Ann. Surg., 237(1):52-56.

[33]Mitchell, P.J., Sagar, P.M., 2014. Emerging surgical therapies for faecal incontinence. Nat. Rev. Gastroenterol. Hepatol., 11(5):279-286.

[34]Mundy, L., Merlin, T.L., Maddern, G.J., 2004. Systematic review of safety and effectiveness of an artificial bowel sphincter for faecal incontinence. Br. J. Surg., 91(6):665-672.

[35]Nandivada, P., Nagle, D., 2014. Surgical therapies for fecal incontinence. Curr. Opin. Gastroenterol., 30(1):69-74.

[36]O'Brien, P.E., Skinner, S., 2000. Restoring control. Dis. Colon Rectum, 43(9):1213-1216.

[37]O'Brien, P.E., Dixon, J.B., Skinner, S., et al., 2004. A prospective, randomized, controlled clinical trial of placement of the artificial bowel sphincter (Acticon Neosphincter) for the control of fecal incontinence. Dis. Colon Rectum, 47(11):1852-1860.

[38]Ortiz, H., Armendariz, P., Demiguel, M., et al., 2002. Complications and functional outcome following artificial anal sphincter implantation. Br. J. Surg., 89(7):877-881.

[39]Parker, S.C., Spencer, M.P., Madoff, R.D., et al., 2003. Artificial bowel sphincter. Dis. Colon Rectum, 46(6):722-729.

[40]Perry, S., Shaw, C., Mcgrother, C., et al., 2002. Prevalence of faecal incontinence in adults aged 40 years or more living in the community. Gut, 50(4):480-484.

[41]Rao, S.S., 2004. Diagnosis and management of fecal incontinence. Am. J. Gastroenterol., 99(8):1585-1604.

[42]Rojas, R.G., Atan, I.K., Shek, K.L., et al., 2014. Anal sphincter trauma and fecal incontinence in urogynecological patients. Neurourol. Urodynam., 33(6):856-858.

[43]Romano, G., la Torre, F., Cutini, G., et al., 2003. Total anorectal reconstruction with the artificial bowel sphincter: report of eight cases. Dis. Colon Rectum, 46(6):730-734.

[44]Ruiz Carmona, M.D., Alós Company, R., Roig Vila, J.V., et al., 2009. Long-term results of artificial bowel sphincter for the treatment of severe faecal incontinence. Are they what we hoped for? Colorectal Dis., 11(8):831-837.

[45]Ruthmann, O., Richter, S., Seifert, G., et al., 2010. The first teleautomatic low-voltage prosthesis with multiple therapeutic applications: a new version of the German Artificial Sphincter System. Artif. Organs, 34(8):635-641.

[46]Savoye, G., Leroi, A., Denis, P., 2000. Manometric assessment of an artificial bowel sphincter. Br. J. Surg., 87(5):586-589.

[47]Schrag, H., Padilla, F., Doll, A., et al., 2004. German Artificial Sphincter System—GASS. Development and in vitro evaluation of a novel, fully-implantable, highly integrated sphincter prosthesis for therapy of high-grade fecal incontinence. Biomed. Tech., 49(10):274-278 (in German).

[48]Tan, J.J., Chan, M., Tjandra, J.J., 2007. Evolving therapy for fecal incontinence. Dis. Colon Rectum, 50(11):1950-1967.

[49]Teunissen, T., van den Bosch, W., van den Hoogen, H., et al., 2006. Prevalence of urinary and faecal incontinence among community-dwelling elderly patients in Nijmegen, the Netherlands, January 1999-July 2001. Ned. Tijdschr. Geneeskd., 150(44):2430-2434 (in Dutch).

[50]Tobin, G.W., Brocklehurst, J., 1986. Faecal incontinence in residential homes for the elderly: prevalence, aetiology and management. Age Ageing, 15(1):41-46.

[51]Vaizey, C.J., Kamm, M.A., Gold, D.M., et al., 1998. Cinical, physiological, and radiological study of a new purpose-designed artifical bowel sphincter. Lancet, 352(9122):105-109.

[52]Vaizey, C.J., Carapeti, E., Cahill, J.A., et al., 1999. Prospective comparison of faecal incontinence grading systems. Gut, 44(1):77-80.

[53]Walter, S., Hallböök, O., Gotthard, R., et al., 2002. A population-based study on bowel habits in a Swedish community: prevalence of faecal incontinence and constipation. Scand. J. Gastroenterol., 37(8):911-916.

[54]Wong, W.D., Jensen, L.L., Bartolo, D.C., et al., 1996. Artificial anal sphincter. Dis. Colon Rectum, 39(12):1345-1351.

[55]Wong, W.D., Congliosi, S.M., Spencer, M.P., et al., 2002. The safety and efficacy of the artificial bowel sphincter for fecal incontinence. Dis. Colon Rectum, 45(9):1139-1153.

[56]Zan, P., Yan, G.Z., Liu, H., 2008. Modeling of human colonic blood flow for a novel artificial anal sphincter system. J. Zhejiang Univ.-Sci. B, 9(9):734-738.

[57]Zan, P., Yang, B.H., Shao, Y., et al., 2010. Electromagnetic effects on the biological tissue surrounding a transcutaneous transformer for an artificial anal sphincter system. J. Zhejiang Univ.-Sci. B (Biomed. & Biotechnol.), 11(12):931-936.