Safety Evaluation of Laparoscopically Applied Clips

Abstract

We have evaluated in vitro, the security of laparoscopically applied clips, through two commercially available clip appliers: the Endo Clip II (US Surgical) and the Ligaclip (Ethicon). The clip performance was tested with respect to dislodgment and leakage. Dislodgment was attempted both transversely and at 45 degrees with respect to the main axis of the tubular structures tested. The mean maximum force (N = 24) necessary to dislodge a clip applied to silicone tubing (2.1, 2.4, 3.2 mm o.d.) and porcine vascular tissue was measured. The maximum force needed to transversely dislodge a clip applied to silicone tubing, ranged from 262 +/- 9 g (2.1 mm) to 315 +/- 11 g (3.2 mm) for the Endo Clip II applier, while the values for the Ligaclip were 220 +/- 28 g (2.1 mm) and 273 +/- 11 g (3.2 mm), respectively. To achieve dislodgment at 45 degrees pull, corresponding forces of 294 +/- 8 g (2.1 mm) and 369 +/- 14 g (3.2 mm) for the Endo Clip II, and 254 +/- 14 g (2.1 mm) and 297 +/- 13 g (3.2 mm) for the Ligaclip (N = 24) were required. Transverse dislodgment forces, for clips applied to tissue, were 556 +/- 146 g for the Endo Clip II and 356 +/- 170 for the Ligaclip (N = 6). Leakage tests were also performed under pulsatile blood circulation at mean pressure of approximately 800 mm Hg. No tested clips applied to either silicone tubing or tissue allowed for any blood leakage. The dislodgment test showed that the Endo Clip II exhibits superior performance compared to the Ligaclip, based on the fact that it requires more force for transverse and semiaxial dislodgment. In the leakage test, both clip appliers performed equivalently.