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Preliminary performance of a flexible cap and catheter-based endoscopic suturing system
Erica A Moran1, Christopher J Gostout, Juliane Bingener
1Department of Gastroenterologic and General Surgery, Mayo Clinic, Rochester, Minnesota 55905, USA.
Background:
Translation of natural orifice transluminal endoscopic surgery (NOTES) into clinical applications requires efficient and reliable enterotomy closure.
Objective:
To evaluate a prototype endoscopic suturing system for enterotomy closure.
Design:
This study took place in an ex vivo animal laboratory. Isolated porcine stomachs were contained within a plastic molded abdominal torso. The device specifications included a curved needle, end-cap assembly with a side-mounting wire-actuation channel, a needle-exchange assembly that operates within an endoscopic working channel, and a detachable needle tip attached to suture material.
Interventions:
Mucosal templates (3-cm circular markings) for targeted suture placement were created along the anterior wall of the stomach (cardia, antrum, and body). Device performance and functionality were studied in 3 ways: suture placement, purse-string closure, and edge-to-edge gastrotomy closure. Interrupted and running stitches were placed with the endoscope straight and retroflexed. Simple leak testing was conducted.
Results:
Sutures could accurately be placed at preset templated markings. Creation of a purse-string gastrotomy closure confirmed the capability to place a set of circumferential full-thickness running sutures during a single endoscopic intubation that resulted in a leak-proof closure. Edge-to-edge full-thickness tissue apposition was accomplished, which provided a water-tight closure of an 18-mm gastrotomy. The device worked consistently, without any problems.
Conclusions:
This endoscopic suturing device provided accurate placement of full-thickness sutures during a single intubation and permitted satisfactory tissue apposition. Standardized leak testing is needed for further development and evaluation of new devices. The catheter-driven needle actuator and the transfer-component system were intuitive and universally adaptable to any endoscope. This closure device may advance transluminal therapies by offering a secure, efficient method of hollow viscus closure.
