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

Abstract

Richard W Timm, Ryan M Asher, Karalyn R Tellio, Alissa L Welling, Jeffrey W Clymer, Joseph F Amaral Ethicon Inc., Cincinnati, OH, USA Introduction: Ultrasonic energy is a mainstay in the armamentarium of surgeons, providing multifunctionality, precision, and control when dissecting and sealing vessels up to 5 mm in diameter. Historically, the inability to seal vessels in the 5–7 mm range has been perceived as an inherent limitation of ultrasonic technology. The purpose of this study was to evaluate sealing of vessels up to 7 mm in diameter with an ultrasonic device that modulates energy delivery during the sealing period. Methods: In ex vivo benchtop and in vivo acute and survival preclinical models, a new ultrasonic device, Harmonic ACE®+7 Shears (Harmonic 7), was compared with advanced bipolar devices in sealing vessels 1–7 mm in diameter with respect of burst pressure, seal reliability, and seal durability. Lateral thermal damage and transection time were also evaluated. Results: Ex vivo tests of Harmonic 7 demonstrated significantly greater median burst pressures than an advanced bipolar device both for vessels <5 mm in diameter (1,078 mmHg and 836 mmHg, respectively, P=0.046) and for those in the range of 5–7 mm (1,419 mmHg and 591 mmHg, P<0.001). In vivo tests in porcine and caprine models demonstrated similar rates of hemostasis between Harmonic 7 and advanced bipolar devices, with high success rates at initial transection and seal durability of 100% after a 30-day survival period. Conclusion: Sealing 5–7 mm vessels is not a limitation of the type of energy used but of how energy is delivered to tissue. These studies document the ability of ultrasonic energy alone to reliably seal large vessels 5–7 mm in diameter, with significantly greater burst pressure observed in in vitro studies than those observed with an advanced bipolar technology when energy delivery is modulated during the sealing cycle. Furthermore, the seals created in 5–7 mm vessels are shown to be reliable and durable in in vivo preclinical studies. Keywords: ultrasonic, Harmonic, vessel sealing, burst pressure, 7 mm