Understanding the mechanical behavior of intrauterine devices during simulated removal

Abstract

ObjectiveTo evaluate differences based on intrauterine device (IUD) frame geometry in force, and stress, and strain at the stem/arms junction during simulated IUD removal. Study designWe manufactured injection-molded frame models for three Nova-T IUDs (Mirena [model M]; Liletta [model L]; Kyleena [model K]) and a Tatum-T IUD (Paragard [model P]) at two-times scaling. We created a custom fixture to simulate the uterus and used a screw-driven machine to pull models at various displacement rates through the 10 cm fixture cavity to measure force and strain and calculate stress at the IUD stem/arms junction. We tested models at 30 mm/min and higher displacement rates for exploratory analyses. We used Mann-Whitney U test for statistical testing. ResultsWe completed testing at 30 mm/min using five of each Nova-T model and nine model P samples. Resistance against the cavity walls created significantly more force on model P (11.83, interquartile range [IQR] 11.61–12.31) than any Nova-T model samples (p < 0.001). The smaller model K created slightly more median stress (MPa) than the larger model M (0.36 [IQR 0.33–0.38] and 0.79 [IQR 0.76–0.80], respectively, p = 0.008); model P samples generated significantly more median stress than other models (1.70 [IQR 1.67–1.77], p < 0.001). Strain plots demonstrated permanent deformation for some samples during IUD removal simulation. We tested 20 samples at various higher displacement rates up to 2500 mm/min, with stress notably increasing for model P samples with increasing rates. No fractures occurred. ConclusionsForce and stress at the stem/arms junction are higher with Tatum-T-shaped compared to Nova-T-shaped IUD models under the same testing conditions, and a higher speed of extraction causes more stress. ImplicationsSharp corners create vulnerability under static and fatigue loading in structural components due to increased local stresses. Our findings suggest that IUDs with Tatum-T frames should be removed slowly to minimize the stress at the stem/arms junction. Future studies can provide more information if performed with commercially available products.