Safety assessment of electrosurgical electrodes by using mini pig tissue

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.

Keywords: Electrosurgery; Electrosurgical electrodes; Safety; Thermal tissue effect.

Fig. 1

Thermal imaging areas for each mode of skin (A–B), liver (C–D), kidney (E–F), femoral muscle (G–H) tissue. Data were represented by mean ± S.E. The results were statistically analyzed by Student's t-test. Statistically difference between LIPO and Positive con. was presented as ++ with P < 0.01. Statistically difference between LIFT and Positive con. was presented as * (P < 0.05), ** (P < 0.01). Underline: Not equal variance (Welch's t-test). Ret.: Retraction (continuous) mode; eMu: eMulsify (pulse) mode. Subject devices: AE40-300 (LIPO) and AE20-80 (LIFT). Predicate device: Injectable RF Electrode (V-10-10-18-B-G2) (Positive con. (PC.)).

Fig. 2

The maximum temperatures for each mode of skin (A–B), live (C–D), kidney (E–F), femoral muscle (G–H) tissues. Data were represented by mean ± S.E. The results were statistically analyzed by Student's t-test. Statistically difference between LIPO and Positive con. was presented as + with P < 0.05, and ++ with P < 0.01. Statistically difference between LIFT and Positive con. was presented as * (P < 0.05), ** (P < 0.01). Underline: Not equal variance (Welch's t-test). Ret.: Retraction (continuous) mode; eMu: eMulsify (pulse) mode. Subject devices: AE40-300 (LIPO) and AE20-80 (LIFT). Predicate device: Injectable RF Electrode (V-10-10-18-B-G2) (Positive con. (PC.)).

Fig. 3

Times reaching the basal temperature for each mode in skin (A–B), liver (C–D), Kidney (E–F), and femoral muscle (G–H) tissues. Data were represented by mean ± S.E. The results were statistically analyzed by Student's t-test. Statistically difference between LIFT and Positive con. was presented as * (P < 0.05). Ret.: Retraction (continuous) mode; eMu: eMulsify (pulse) mode. Subject devices: AE40-300 (LIPO) and AE20-80 (LIFT). Predicate device: Injectable RF Electrode (V-10-10-18-B-G2) (Positive con. (PC.)).

Fig. 4

Hematoxylin and eosin (H&E) staining of the thermal injury-induced necrosis areas for each mode of electrodes in skin (A), liver (B), kidney (C), and femoral muscle (D) tissues. The dashed circle indicates the location of the surgical wound. Subject devices: AE40-300 (LIPO) and AE20-80 (LIFT). Predicate device: Injectable RF Electrode (V-10-10-18-B-G2). Scale bar: 600 μm.

Fig. 4

Hematoxylin and eosin (H&E) staining of the thermal injury-induced necrosis areas for each mode of electrodes in skin (A), liver (B), kidney (C), and femoral muscle (D) tissues. The dashed circle indicates the location of the surgical wound. Subject devices: AE40-300 (LIPO) and AE20-80 (LIFT). Predicate device: Injectable RF Electrode (V-10-10-18-B-G2). Scale bar: 600 μm.

Fig. 5

Thermal injury-induced necrosis areas for each mode in skin (A–B), liver (C–D), Kidney (E–F), and femoral muscle (G–H) tissues. Data were represented by mean ± S.E. The results were statistically analyzed by Student's t-test. Statistically difference between LIPO and Positive con. was presented as + with P < 0.05, and ++ with P < 0.01. Statistically difference between LIFT and Positive con. was presented as * (P < 0.05). Underline: Not equal variance (Welch's t-test). Ret.: etraction (continuous) mode; eMu: eMulsify (pulse) mode. Subject devices: AE40-300 (LIPO) and AE20-80 (LIFT). Predicate device: Injectable RF Electrode (V-10-10-18-B-G2) (Positive con. (PC.)).