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Involuntary female infertility represents a sensitive issue, which is frequently caused by an impaired patency of the Fallopian tube. Current treatment options, such as in vitro fertilisation (IVF) or tubal reconstruction, are related to high costs or surgical risks. Therefore, a need for an alternative highly safe and effective minimally invasive therapy option is assumed. The current work presents a proof-of-concept for a novel microstent in combination with a delivery system for treatment of proximal Fallopian tube occlusions. For this purpose, a microstent prototype was implanted into a porcine Fallopian tube ex vivo using the presented delivery system. The results of the procedure were analyzed using a micro-computed tomography (μ-CT). Based on the μ-CT imaging, critical parameters of the microstent, such as radial patency, were assessed. The microstent implantation leads to an increased opening area of the Fallopian tube. Additionally, the microstent does not impair the anatomical shape of the tube epithelium and adapts well to the anatomical path. In further studies, the functionality of the Fallopian tube will be examined after microstent implantation in vivo.

Proximal occlusion of the Fallopian tube is one of the most common causes of female infertility. Due to the occlusion, the passage of the fallopian tubes is no longer given. Basically, there are two options for patients affected by this condition: cost-intensive in vitro fertilization (IVF) or surgery. The pregnancy rates of approximately 50% achieved with current treatment options are not satisfying. In this work, we present a Finite Element Analysis (FEA) model of a previously reported optimized microstent design for minimally invasive therapy of proximal tubal occlusion. Based on experimental investigations, the material model was set up and the simulation was validated. Comparison of the mechanical performance as an application related critical load case was in a good agreement. In this work, the proof of concept for the FEA model and the material model were carried out. In the future, the simulation will be used for further load cases such as the investigation of the bending stiffness and radial force and for the design optimization.