Preliminary performance of a flexible cap and catheter-based endoscopic suturing system.

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.

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