Research on biomechanical compatibility for a novel artificial anal sphincter with constant force.

Background: Existing artificial anal sphincter studies have shown that biomechanical compatibility problem between artificial anal sphincter and rectum caused by long‐term morphological changes of the tissue surrounding the implanted prosthesis can lead to device failure or tissue ischemic necrosis. In this article, a mechanical artificial anal sphincter with constant force clamping is designed based on the superelasticity of shape memory alloys, which improved the biomechanical compatibility of implantable artificial anal sphincter. Methods: Firstly, the anatomical structure and the biomechanical properties of the rectum are analyzed to obtain the size parameters and material parameters of the rectal model. Secondly, a novel artificial anal sphincter with constant force is designed to improve the biomechanical compatibility between the artificial sphincter and the rectum. Thirdly, the static analysis of artificial anal sphincter is carried out by finite element analysis. Results: The simulation results show that the artificial anal sphincter can maintain a constant clamping force of 4 N within a certain variation range of intestinal tissue thickness, which verifies the constant force characteristic of the artificial anal sphincter. The constant clamping force of the artificial anal sphincter to the rectum is 4 N that is greater than the clamping force 3.99 N required to close the rectum, which verifies the effectiveness the artificial anal sphincter. The surface contact stress and the minimum principal stress of the rectum in the clamping state are less than the pressure threshold, which verifies the safety of the artificial anal sphincter. Conclusions: The novel artificial anal sphincter has better biomechanical compatibility and improves the mechanical match between artificial sphincter and intestinal tissue. This study may provide more reasonable and effective simulation data for in vivo experiments of artificial anal sphincter in future, which may provide theoretical and technical support for further research about clinical application of artificial anal sphincter. [ABSTRACT FROM AUTHOR]