Novel, Remotely Controlled, Artificial Urinary Sphincter: A Retro-Compatible Device

Implantation of artificial urinary sphincters (AUSs) is considered to be the gold standard treatment in severe cases of stress urinary incontinence. The functioning of these implants is purely hydromechanical, as they apply constant pressure around the bulbous urethra. Common reasons for device revision are insufficient cuff pressure and, in contrast, urethral atrophy secondary to this constant pressure. Furthermore, functioning requires some dexterity, limiting their implantation in some patients. We present in this study a novel electronic AUS that offers the possibility of remotely controlling the sphincter rapidly and without mechanical effort. The implant's embedded software can also be updated remotely. Its design eliminates the manual pump, making implantation easier in men and women. Furthermore, it is compatible with already-implanted AUS and can be employed for treating other sphincter deficiencies. The device has been tested on a custom test bed and on pig bladders in vitro. Different occlusive cuff pressure ranges were employed and acceptable performance was obtained. Design challenges and results are reported and discussed here.