An implantable mechanical urinary sphincter: A new nonhydraulic design concept

Objectives. We present data concerning an artificial implantable mechanical urinary sphincter that was designed to eliminate the inherent problems of the current hydraulic artificial urinary sphincter (American Medical System [AMS] 800). Our goal was to design a sphincter that creates urethral compression similar to the AMS 800 but creates the force without the use of fluid, thereby eliminating as much as 50% of the reoperations seen with the AMS 800, which occur because of fluid-related malfunctions. Methods. An implantable artificial mechanical sphincter consisting of a compressive coil encompassed in a polytetrafluoroethylene sheath was devised and tested in 6 live mongrel dogs to establish compressive force versus bladder pressure data, so as to provide data to create a mechanical sphincter for use in humans. Results. A direct relationship between bladder leakage pressure and cable tension force was demonstrated in all 6 experimental animals, thereby creating a mathematical equation that can be used by mechanical engineers to design a mechanical sphincter for use in humans. Conclusions. This study demonstrated that a mechanical urinary sphincter can be created that will provide continence and eliminate the problems associated with the hydraulic aspect of the AMS 800. In doing so, nearly 50% of the reoperations seen with the current AMS 800 can be eliminated, thereby improving the quality of life of patients for whom an artificial urinary sphincter is indicated.