本文对目前临床使用的人工括约肌的安全性与有效性进行分析与讨论,对国内外目前正在开发的新装置和新方法进行比较,归纳出人工肛门括约肌在临床应用中遇到的关键问题是维持植入体与周围生物组织的远期力学相容性,该问题有望通过智能材料的利用得到解决。
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 be- tween 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.