Evaluation of loading behavior of a selfexpanding polymeric microstent for the treatment of Fallopian tube occlusions

Abstract

Female sterility is caused by Fallopian tube occlusions in one of three cases. Current treatment methods achieve unsatisfying pregnancy rates and are associated with high costs or significant psychological and physiological stress. Our previously described microstent technology opens up new therapeutic possibilities to restore the lumen of the Fallopian tube without surgery. In this work, a Finite Element Analysis model of a physiologically relevant loading of the device is presented. Therefore, microstent radial force was analysed as a function of the device diameter up to a minimum diameter of 1.4 mm, which was found after microstent implantation ex vivo. A bilinear constitutive material model considering isotropic hardening was used for modeling of the microstent. The Finite Element Analysis results were validated using corresponding results of experimental investigations. In this context, a maximum deviation of 15% between experimental radial force and the corresopnding simulation results (1.33 N vs. 1.13 N) was found. Maximum von Mises stresses of approximately 88 MPa were determined. A good agreement between simulation and experiments was found. Therefore, future simulations will be carried out as a basis for microstent design optimisation.

Keywords

• biodegradable microstent
• fallopian tube occlusion
• enabling pregnancy
• fertility treatment
• fea