Mechanical and morphological characterisation of porcine urethras for the assessment of paediatric urinary catheter safety

Paediatric urinary catheters are often necessary in critical care settings or to address congenital anomalies affecting the urogenital system. Iatrogenic injuries can occur during the placement of such catheters, highlighting the need for a safety device that can function in paediatric settings. Despite successful efforts to develop devices that improve the safety of adult urinary catheters, no such devices are available for use with paediatric catheters. This study investigates the potential for utilising a pressure-controlled safety mechanism to limit the trauma experienced by paediatric patients during inadvertent inflation of a urinary catheter anchoring balloon in the urethra. Firstly, we establish a paediatric model of the human urethra using porcine tissue by characterising the mechanical and morphological properties of porcine tissue at increasing postnatal timepoints (8, 12, 16 and 30 weeks). We identified that porcine urethras harvested from pigs at postnatal week 8 and 12 exhibit morphological properties (diameter and thickness) that are statistically distinct from adult porcine urethras (postnatal week 30). We therefore utilise urethra tissue from postnatal week 8 and 12 pigs as a model to evaluate a pressure-controlled approach to paediatric urinary catheter balloon inflation intended to limit tissue trauma during inadvertent inflation in the urethra. Our results show that limiting catheter system pressure to 150 kPa avoided trauma in all tissue samples. Conversely, all of the tissue samples that underwent traditional uncontrolled urinary catheter inflation experienced complete rupture. The findings of this study pave the way for the development of a safety device for use with paediatric catheters, thereby alleviating the burden of catastrophic trauma and life changing injuries in children due to a preventable iatrogenic urogenital event. </p