Development of an ultrasonic device with up to 7-mm vessel sealing capacity

Alissa L Welling, RVT, LATG, SRS, Karalyn R Tellio, MSE, Jeffrey W Clymer, PhD, Joseph F Amaral, MD, FACS. Ethicon Endo-Surgery, Inc..

Objective: Ultrasonic energy in surgery is a mainstay in the armamentarium of surgeons, but is limited by its ability to seal vessels only up to 5 mm in diameter. HARMONIC ACE®+7 is a recently FDA-cleared device that leverages Adaptive Tissue Technology to optimize the delivery of energy, and introduces an Advanced Hemostasis mode that modulates the energy level to achieve large vessel (5-7 mm diameter) sealing. The purpose of this study was to evaluate the performance of this ultrasonic device in benchtop burst pressure testing of large vessels and pre-clinical sealing efficacy and durability.

Methods: HARMONIC ACE®+7 devices were used to seal and transect porcine carotid arteries of 3-7.5 mm diameter via in vitro benchtop testing. Leaks at transection and burst pressures were measured. Devices were operated at Power Level 3 and in the Advanced Hemostasis mode for vessels under 5 mm, and in the Advanced Hemostasis mode only for vessels greater than 5 mm. Pre-clinical acute and survival studies using an in vivo porcine model were also performed. All procedures were reviewed and the animals approved for use by the Ethicon Endo-Surgery Institutional Animal Care and Use Committee. In the acute studies, hemostasis was evaluated intra-operatively at transection and after a blood pressure challenge in which the mean systolic pressure was elevated to at least 200 mm Hg for a period of 10 minutes to simulate an acute hypertensive crisis. In the survival studies, hemostasis was evaluated intraoperatively and after a 30 day survival period and simulated hypertensive crisis. 

Results: In vitro testing indicated that the Advanced Hemostasis mode produced a high rate of sealing and provided burst pressures for both 3-5 mm and 5-7 mm vessels that were the same as or greater than those for Power Level 3 in 3-5 mm vessels. In vivo testing showed that both Power Level 3 and Advanced Hemostasis produced a high rate of initial hemostasis with no failures during an acute simulated hypertensive crisis.  All vessel seals remained intact after a 30-day survival period and acute simulated hypertensive crisis.

In Vitro Results
Power Mode Vessel Diameter Leaks at Transection
Power Level 3 3-5 mm 2/40
Adv Hemostasis 3-5 mm 1/40
Adv Hemostasis >5-7 mm 0/40

 

In Vivo Results

Power Mode Vessel Diameter Leaks at Transection At Acute Challenge At Survival Challenge
Level 3 1-5 mm 1/96 0/96 0/24
Adv Hemost 2-7 mm 0/72 0/72 0/24

Conclusions: These studies document the ability of ultrasonic energy with Adaptive Tissue Technology to fuse and divide vessels in vitro and in vivo, and show the benefit of including predictive analytics to improve performance. This is the first demonstration of a device that can create strong, durable seals in vessels up to 7 mm diameter solely using ultrasonic energy
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