A Novel Artificial Anal Sphincter System in an in Vitro and in Vivo Experiment

Abstract

This paper presents some of the latest progress in the development of a novel artificial anal sphincter system (AASS) to treat severe fecal incontinence. We have redesigned and integrated an intelligent, remote-controlled artificial anal sphincter based on biological signal feedback mechanisms. The device consists of an external telemetry unit, an internal artificial anal sphincter (IAAS), and a transcutaneous energy transfer system (TETS). The mechanical medical micropump of the IAAS can realize bidirectional flow with a maximum flow rate of 8.5 ml/min and can build backpressure up to 170 kPa. The design of the prosthesis reduces occlusion pressure and allows for low inflation volumes (9 mL-10.5 mL); operating pressures between 4.05 kPa and 7.16 kPa indicate that the risk of ischemic injury to the bowel is minimal. Furthermore, the rechargeable battery based on TETS puts the operation time at an estimated 2 days. The performance characteristics of the AASS and its efficiency in achieving continence and sensing the stool inside the anorectum were evaluated in vitro and in vivo in a pig model. Experimental results confirm that the system can maintain continence and build the sense of defecation successfully. Moreover, this innovation can be integrated into not only severe fecal incontinence, erectile dysfunction, and therapy-resistant reflux disease, but also morbid adiposity therapeutic AASS applications.