German Artificial Sphincter System--GASS. Development and in vitro evaluation of a novel, fully-implantable, highly integrated sphincter prosthesis for therapy of high-grade fecal incontinence

No highly integrated sphincter prosthesis for therapy of major fecal incontinence exists. Therefore, we developed a novel neosphincter, made of polyurethane. The GASS consists of a support ring (SR) which includes a fluid reservoir, fixed on the outer diameter of the SR, and a multi-chamber occluding cuff (C(int)) on the inside diameter. The total inflation volume of C(int) is about 23 cc. The integrated micropump based on piezotechnology measures 30x13x1 mm3 (flowrate 1.4 cc/min, max. backpressure 40,000 Pa) . GASS was evaluated around the external sphincter of isolated porcine anal canals. The threshold of continence was defined as the inflating volume which water ceased to leak through the area occluded by C(int) under an induced rectal pressure of 150 cm H2O. Minimal filling volumes maintained continence for liquids against high luminal pressures. A low intraanal resting pressure (delta p(anal)) induced by activated GASS indicates a little risk of ischemic injury of the anal canal in vivo (median delta p(anal) 24.1 mm hg:15 cc vs 46.9 mm hg:21 cc). In summary, a highly integrated and efficient high-tech neosphincter for the therapy of major fecal incontinence could be realized.