Pinch Valve Approach for a Biofilm Resistant Mechatronic Intraurethral Artificial Urinary Sphincter*

Stress urinary incontinence is the involuntary leakage of urine during increased abdominal pressure, such as coughing, sneezing, laughing, or exercising. It can have a significant negative impact on a person's quality of life and can result in decreased physical activity and social isolation. The presented closure mechanism for a mechatronic intraurethral artificial urinary sphincter is designed to be inserted minimally invasive into the urethra. The device consists of a solid shell, which serves as a housing for the electronics and is designed to enable fixation in the urethra. During micturition, the urine flows through the system, where it is guided through an elastic silicone-tube that, on the one hand, enables closure by a squeezing mechanism and, on the other hand, prevents biofilm growth by oscillation at a frequency of 22.5 Hz. The squeezing mechanism consists of a pinch valve system actuated by a piezo motor. The system has been tested under urodynamic conditions and the results show that it is able to close the urethra effectively to restore continence. The device is able to withstand sudden loads and shows good performance in terms of biofilm prevention during first experiments with artificial urine. The results show that the mechatronic intraurethral artificial urinary sphincter has the potential to be an effective and minimally invasive alternative to current treatment options for stress urinary incontinence.Clinical Relevance— This novel concept of a mechatronic intraurethral artificial urinary sphincter presents a promising alternative treatment option for patients suffering from stress urinary incontinence. As it is designed to be inserted minimally invasive, it reduces the impact and complications associated with current treatment options. The future development and testing of the device could lead to a safe and effective option for clinicians to offer their patients with stress urinary incontinence, which can improve their quality of life, and decrease costs for society and healthcare systems.