Safety assessment of electrosurgical electrodes by using mini pig tissue

利用小型猪组织对电外科电极进行安全性评估

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Abstract

Electrosurgical electrodes are the main dissecting devices widely used for surgeries throughout the world. The present study aimed to evaluate the thermal injury and safety within animals' organs following a minimally invasive electrosurgery technique with electrosurgical electrode AE40-300 (LIPO) and AE20-80 (LIFT). To ensure the effective application of electrosurgery in a clinical environment, it is crucial to minimize heat-induced injury to nearby tissues. In this study, the skin, liver, kidney, and femoral muscle dissected from 9 minipigs were used in tissue thermal spread experiments. Thermal imaging area analysis, maximum temperature, and time to reach basal temperature were evaluated. Thermography results revealed that the surgical temperature was significantly lower in the minimally invasive electrosurgery with AE40-300 (LIPO) and AE20-80 (LIFT) compared to the predicate device. In addition, AE40-300 (LIPO) and AE20-80 (LIFT) created a relatively small thermal injury area and thermal diffusion. Our results indicated that the tested devices named AE40-300 (LIPO) and AE20-80 (LIFT) reduced excessive thermal injury and could be applied to clinical use safely.

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