Medical Devices: Evidence and Research (Apr 2015)
Consistency and sealing of advanced bipolar tissue sealers
Abstract
Edward G Chekan , Mark A Davison, David W Singleton, John Z Mennone, Piet Hinoul Ethicon, Inc., Cincinnati, OH, USA Objectives: The aim of this study was to evaluate two commonly used advanced bipolar devices (ENSEAL® G2 Tissue Sealers and LigaSure™ Blunt Tip) for compression uniformity, vessel sealing strength, and consistency in bench-top analyses. Methods: Compression analysis was performed with a foam pad/sensor apparatus inserted between closed jaws of the instruments. Average pressures (psi) were recorded across the entire inside surface of the jaws, and over the distal one-third of jaws. To test vessel sealing strength, ex vivo pig carotid arteries were sealed and transected and left and right (sealed) halves of vessels were subjected to burst pressure testing. The maximum bursting pressures of each half of vessels were averaged to obtain single data points for analysis. The absence or presence of tissue sticking to device jaws was noted for each transected vessel. Results: Statistically higher average compression values were found for ENSEAL® instruments (curved jaw and straight jaw) compared to LigaSure™, P<0.05. Moreover, the ENSEAL® devices retained full compression at the distal end of jaws. Significantly higher and more consistent median burst pressures were noted for ENSEAL® devices relative to LigaSure™ through 52 firings of each device (P<0.05). LigaSure™ showed a significant reduction in median burst pressure for the final three firings (cycles 50–52) versus the first three firings (cycles 1–3), P=0.027. Tissue sticking was noted for 1.39% and 13.3% of vessels transected with ENSEAL® and LigaSure™, respectively. Conclusion: In bench-top testing, ENSEAL® G2 sealers produced more uniform compression, stronger and more consistent vessel sealing, and reduced tissue sticking relative to LigaSure™. Keywords: ENSEAL, sealing, burst pressure, laparoscopic, compression, LigaSure