A fully implantable sensorized artificial urinary bladder to restore continence and fullness monitoring.

Abstract

A fully implantable sensorized organ to replace the natural urinary bladder holds considerable promise for patients undergoing radical cystectomy. Clinical options to restore continence include urine redirection to wearable bags or reconstruction of neobladders from autologous tissues, often with limited capacity. However, none of these approaches can restore patient's ability to perceive bladder fullness, making voiding self-management complex and burdensome. To address these limitations, we introduce the Soft Self-Sensitive Artificial Bladder (S3AB), a fully implantable sensorized organ designed to replace urinary bladder anatomy, as well as continence and fullness monitoring. The S3AB main component is a silicone origami-inspired bladder designed to fit the abdominopelvic cavity. The foldable and soft nature facilitates the maintenance of intravesical pressure below the physiological range, thereby promoting the preservation of renal function over time. The bladder is integrated with a multi-sensor system based on resistive textile sensors featuring durability and functionality throughout repetitive cycles of filling and draining. The sensors demonstrate stability at physiological temperatures. Once isolated from bodily fluids, textile sensors permit to monitor the bladder internal volume leveraging on the origami structure opening during filling, with an estimation accuracy within approximately 12%. Volume monitoring allows warning the patient when the maximum capacity is almost reached, thus making possible a natural micturition management. S3AB proved efficient in restoring urine collection and filling state monitoring upon successful implantation in a large animal model.