New anchoring mechanism and design of an endoluminal duodeno-jejunal bypass liner for treatment of obesity and T2DM.

Abstract

Background: Bariatric surgery is the most effective method of achieving sustained weight loss compared to conservative interventions. Less invasive treatment options have emerged. One of such is the EndoBarrierTM a single use endoluminal duodenojejunal bypass liner (DJBL). Designed for obesity and T2DM management, the DJBL is an implantable device in the form of a 60cm impermeable fluoropolymer sleeve liner fitted with a delivery/retrieval system, placed endoscopically and anchored in the first part of the small bowel (duodenum). Objective(s): Determine the effectiveness of a new DJBL without barbs. Assess weight loss. Method(s): A newly designed DJBL, fitted with a circular expanded anchor (with no barbs) with a conical shaped polymer rosette extension. A novel anchoring device was developed to provide strong fixation of the liner by attachment to the pyloric antrum rather than the proximal duodenum used in the previous device. The modified DJBL sleeve and its fixation method were trialled in-vivo using 2 adult pigs. Both pigs were maintained together with the same diet over the two month period. Ethics Committee approval obtained. The aims were to investigate the feasibility of implantation and the ability of the liner to stay fixed over a period. The weight gain of the pigs was also monitored. The results and post mortem findings were evaluated. Result(s): The newly designed device was anchored and monitored for 1 month and found to be intact with no complications. Conclusion(s): The results of this pilot study warrant further investigation of the modified DJBL to assess long term results