Optimization and Validation of an Artificial Bladder Design Through Finite Element Analysis to Meet Clinical Requirements

Bladder cancer and urinary dysfunctions present significant challenges to patient health and quality of life. Considering that radical cystectomy remains the standard treatment for muscle-invasive bladder cancer, there is an urgent need for the implantation of artificial bladders (ABs). In this study, we present the optimization and validation of a novel, collapsible, origami-based AB through Finite Element Method (FEM) simulations. We evaluated various materials and wall thicknesses to improve unfolding capability and minimize structural stress concentrations. Simulations were conducted under different filling conditions, replicating the in-body constraints posed by surrounding organs. The optimal material-thickness combination, namely MoldStar 15 with a 2:1 wall-to-fold ratio, effectively maintained low intravesical pressures during filling (0.5-1.96 kPa), meeting the clinical requirements for renal function preservation. Stress analysis showed Von Mises stresses lower than 2.5 MPa, well below the material’s tensile stress limit, thus ensuring the structural integrity of the device. The AB model was validated by comparing FEM simulation results with a physical prototype, showing a pressure difference of approximately 15% and a volumetric overlap deviation under 10%.