Vacuum inversion and securing of distal colonic pseudodiverticula with novel spiked O-rings

Abstract

Background: Diverticular disease is increasingly prevalent in Western societies and is associated with significant morbidity.

Objective: Two-stage endoscopic device development for inversion and secured ligation of colonic diverticula; first, human cadaver studies were performed to measure forces required for diverticular inversion; second, a novel set of devices (elastic spiked O-ring with delivery system) was tested in animals.

Design: Prospective, observational study of human cadavers and prospective, interventional study of a porcine model.

Setting: University hospital pathology laboratory and animal facility.

Intervention: Full-thickness inversion of the colonic wall with a pipelike delivery instrument to produce an inverted pseudodiverticulum that was secured with a spiked O-ring.

Main outcome measurements: The forces required for diverticular inversion, the secured closure of inverted pseudodiverticula, and the time until necrotic tissue falls off.

Results: A total of 248 of 248 of cadaveric sigmoid diverticula could be inverted by means of vacuum or forceps. The forces required for inversion ranged from 0.28 to 0.47 N (median, 0.37 N). Twenty-four spiked O-rings were delivered in 6 living pigs to produce 24 inverted pseudodiverticula. One animal died the day after the procedure of a pulmonary thromboembolism. In the remaining 5 pigs, all delivered spiked O-rings remained in place for 7 to 22 days. At necropsy, none of the inverted sites showed signs of perforation but rather full-thickness reparative scarring with ingrowth of connective tissue.

Limitations: Animal model, stiff pipelike delivery instrument, variations in diverticular location, diameter, and size.

Conclusions: Endoluminal inversion and securing of colonic diverticula induces tissue necrosis, diverticular sloughing, and full-thickness scarring.