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

Abstract

BackgroundUltrasonic 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).MethodsDevices 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.ResultsACE+ 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.ConclusionThe 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.

Sealing vessels up to 7 mm in diameter solely with ultrasonic technology

“…For example, the addition of adaptive tissue technology to existing devices is associated with lower peak device temperatures, increased seal strength, faster cutting, and improved visualization from reduction in mist. 13 The results observed with adaptive tissue technology are consistent with those observed in piezoelectric surgery in which modulation of energy delivery results in reduced heat and improves the effectiveness of cutting in bone surgery. 19 …”

“…The addition of adaptive tissue technology has been shown to reduce the peak temperatures observed with Harmonic devices in previous studies. 13 Studies also demonstrate that despite increases in blade temperature, minimal conductive heat is transmitted to surrounding tissue, as evidenced by the low amount of lateral thermal damage measured for all Harmonic devices and the ability to operate close to nerves (2 mm) without impacting the electrophysiological function of the nerve. 3 Nevertheless, surgeons must always be mindful that the instrument is hot following activation, and heat mitigation techniques should be employed prior to touching or grasping tissue.…”

“…This was supported by evidence that vessel seals in the 3–5 mm diameter range demonstrated increased burst pressures and decreased thermal damage when adaptive tissue technology was included in the device. 13 …”

Comparing the safety of harmonic ACE and ACE+ around the recurrent laryngeal nerve in swine models

“…Such an adaptive tissue technology uses proprietary algorithms and provides the ability to monitor the thermal condition of the blade [ 15 ]. Using this technology, the generator decreases its power output and makes audible tone changes when minimal tissue remains in the jaw [ 16 ]. Therefore, it allows for an active monitoring to react to changes in tissue conditions while the instrument is in use and consequently helps surgeons avoid unnecessary heat transfers to the surrounding tissues near the RLN.…”

A novel approach to assess minimally invasive surgical device failure utilizing adverse event outcome severity and design complexity.

“…For example, adaptive technology monitors the thermal state of the device blade in addition to the amount of tissue that remains in the jaws. By monitoring these factors, the tissue response generator queues a decrease in delivered power in order to prevent excess thermal injury (Broughton, Welling et al 2013). Despite the elimination of some user-controlled variables, interfaces between technology, surgeons, and patients can still induce a heightened level of stress in the clinical setting, especially when electrical energy is involved.…”