Tissue effects in vessel sealing and transection from an ultrasonic device with more intelligent control of energy delivery

Abstract

Duan Broughton,1 Alissa L Welling,1 Emily H Monroe,1 Kristen Pirozzi,2 John B Schulte,1 Jeffrey W Clymer1 1Ethicon Endo-Surgery, Inc., Cincinnati, OH, 2University of Central Florida, Orlando, FL, USA Background: Ultrasonic surgical devices have been demonstrated to provide excellent hemostasis, efficient transection, minimal lateral thermal damage, low smoke generation, and no risk of electrical current passage to the patient. These benefits originate from the inherent characteristics of the ultrasonic mechanism, but further improvements were thought possible through optimization of the energy delivery during application. The study reported here compared a new ultrasonic device, Harmonic ACE®+ Shears with Adaptive Tissue Technology, with a commercial predicate device, Harmonic ACE® Shears (both Ethicon Endo-Surgery, Inc., Cincinnati, OH, USA). Methods: Devices were evaluated in an in vivo porcine model intraoperatively and after a 30-day survival period. Both devices were used to seal a variety of vessels 1–5 mm in diameter, and compared for hemostasis, histological thermal damage, and adhesion formation. Sealed vessels were evaluated ex vivo for burst pressure, and visual obstruction caused by plumage from device application was assessed quantitatively. Results: ACE+ produced significantly less thermal damage, had fewer adhesions, offered faster transection, involved less visual obstruction, and had higher burst pressures than the predicate device. All vessel seals, evaluated over the course of a 30-day survival period in pigs, remained intact. Conclusion: The new Adaptive Tissue Technology algorithm assists the surgeon in achieving better control of energy delivery to the tissue, sealing vessels with supra-physiological burst pressures, and low thermal damage. These preclinical results with Harmonic ACE+ may translate into meaningful clinical benefits, providing greater precision along with more efficient and effective cutting and coagulation in open or laparoscopic procedures. Keywords: ultrasonic, Harmonic, ACE, vessel sealing, burst pressure, adhesions, Adaptive Tissue Technology