Colon insufflation and visualization management using a novel rectal seal device

Inadequate insufflation is a common problem during colonoscopies, with gas leakage from the anus hindering luminal visualization. This study examines the prevalence of this problem through a survey of gastroenterologists, which motivated the development of our insufflation leakage management rectal seal device, RECSEAL.

The RECSEAL was developed based on the need identified from gastroenterologists regarding the rate and management methods of inadequate insufflation. The RECSEAL, measuring 55 mm in diameter and 50 mm in length, was designed and silicone injection-molded to safely insert and reside in the anal canal without migrating or hindering movement of the colonoscope. To evaluate the RECSEAL, a colonoscope was outfitted with a pressure sensor to measure colonic pressure while visualizing the lumen in a bench, ex vivo, and in vivo in pig models. In the ex vivo study, a small injury was introduced to the anal sphincter to simulate poor anal tone.

The survey reported a rate of inadequate insufflation of 6.6% that required intervention using gluteal pressure maneuvers. In bench testing and the ex vivo model, the RECSEAL maintained lumen pressures in which both an intact and an injured anal sphincter showed significantly higher (P < .0001) mean pressures with the RECSEAL (32-33 mm Hg) than the control (0.3-3.6 mm Hg). The seal improved lumen visualization in the collapsed colon with inadequate insufflation. The RECSEAL was shown to be feasible in an in vivo model.

The flexible RECSEAL allowed higher luminal pressures in the colon and may improve colon insufflation and visualization.