Preclinical Evaluation of a New Surgical Hybrid Energy Device Compared to the Conventional Energy Device

Despite the development of surgical instruments combining ultrasonic scissors and an advanced bipolar device, thermal management has still been considered a persistent issue, similar to that in conventional ultrasonic scissors. To address this issue, the next-generation hybrid device (NGHD) with a new tip and handle design has been devised while maintaining the high cutting and sealing performance of combined surgical instruments (THUNDERBEAT Type S, TBS). We compared them in an ex vivo and nonclinical in vivo environment and investigated their perceived clinical usefulness.

Ex vivo testing included measurements of cutting speed, posterior thermal spread from the jaw, and lateral thermal spread. The nonclinical in vivo study involved evaluations such as cutting capability while maintaining the tissue layer, and handle ergonomics.

The NGHD demonstrated a significantly faster cutting speed than did TBS (2.41 [2.31-2.50] vs. 3.04 [2.94-3.13] s, p < 0.01) with 5-7 mm arteries, as well as significant improvements in the posterior thermal spread on arteries during activation (5.67 [0-12.84] vs. 84.22 [35.34-133.10] μm, p < 0.01) and lateral thermal spread (2.22 [2.06-2.38] vs. 2.79 [2.55-3.03] mm, p < 0.05). Surgeon assessments indicated more improvements with the NGHD than with TBS, especially regarding cutting while maintaining the tissue layer and handle ergonomics.

The NGHD promoted improvements in thermal management generally associated with TBS and maintained the benefits of combining devices capable of ultrasonic and advanced bipolar output. The NGHD has the potential to support safe and efficient endoscopic procedures, pending further clinical evaluation.