Conformation and mechanics of the polymeric cuff of artificial urinary sphincter.

The surgical treatment of urinary incontinence is often performed by adopting an Artificial Urinary Sphincter (AUS). AUS cuff represents a fundamental component of the device, providing the mechanical action addressed to urethral occlusion, which can be investigated by computational approach. In this work, AUS cuff is studied with reference to both materials and structure, to develop a finite element model. Materials behavior is investigated using physicochemical and mechanical characterization, leading to the formulation of a constitutive model. Materials analysis shows that AUS cuff is composed by a silicone blister joined with a PET fiber-reinforced layer. A nonlinear mechanical behavior is found, with a higher stiffness in the outer layer due to fiber-reinforcement. The cuff conformation is acquired by Computer Tomography (CT) both in deflated and inflated conditions, for an accurate definition of the geometrical characteristics. Based on these data, the numerical model of AUS cuff is defined. CT images of the inflated cuff are compared with results of numerical analysis of the inflation process, for model validation. A relative error below 2.5% was found. This study is the first step for the comprehension of AUS mechanical behavior and allows the development of computational tools for the analysis of lumen occlusion process. The proposed approach could be adapted to further fluid-filled cuffs of artificial sphincters.