Objective: Development of ultrasonic technology in surgical devices includes mechanisms of monitoring and adjusting energy delivery to target tissues for the purpose of limiting thermal spread. The objective of the current study was to evaluate performance of a new Adaptive Tissue Technology algorithm, designed to enhance thermal management in the HARMONIC 1100 Shears. Methods: The HARMONIC 1100 Shears were evaluated with bench-top and in vivo preclinical (porcine) analyses for tissue thermal spread, blade heat, transection speed, hemostasis and vessel sealing performance. Testing was performed in parallel with the current production HARMONIC HD 1000i Shears to confirm non-inferiority of the new Adaptive Tissue Technology algorithm. Results: Bench top analysis revealed significantly lower average maximum blade temperatures for HARMONIC 1100 compared to HARMONIC HD 1000i as well as HARMONIC ACE+ 7 Shears with Advanced Hemostasis. Thermal spread, transection speeds, and burst pressure tests of excised porcine carotid arteries did not show a statistical difference between HARMONIC 1100 and HD 1000iShears. In vivo analysis of hemostasis following sealing/transection of various blood vessels in acute porcine testing demonstrated similar efficacy for HARMONIC 1100 and HD 1000i Shears. Likewise, tissue lateral thermal damage showed no statistical difference between the new and previous generation Harmonic device in the porcine model. Conclusion: The new Adaptive Tissue Technology in HARMONIC 1100 Shears allows for reduced maximum blade temperatures while providing effective hemostasis, sealing strength, transection speed, and limited thermal damage.
Background: Over the last two decades use of ultrasonic shears has grown in complex surgery where both precise dissection and meticulous hemostasis is required. With the introduction of HARMONIC® HD 1000i Shears (HD1000i), surgeons can now depend upon a single instrument to perform minimally-invasive dissection while securely sealing vessels up to and including 7 mm in diameter. This study was performed to compare HD1000i to the previous version of the device (HAR7) in sealing, dissecting and adhesion formation.
Background:A new ultrasonic device, Harmonic Focus ® +, has been developed that is smaller and delivers energy more efficiently than its predecessor via the inclusion of Adaptive Tissue Technology. This study was undertaken to compare its dissection capabilities to an advanced bipolar electrosurgery device in benchtop and preclinical evaluations. Methods: In ex vivo testing, Focus+ and LigaSure™ Small Jaw were evaluated for physical dimensions, device and tissue temperature after repeated applications to porcine jejunum, and burst pressure of vessel seals, transection time, and tissue sticking in 3-5 mm porcine carotid arteries. In in vivo testing, the devices were tested on intact porcine carotid arteries for thermal damage via collagen denaturation and in muscle incisions near rat sciatic nerve for acute inflammation via hematoxylin and eosin and for impaired axonal transport via β-APP. Results: Focus+ was smaller than the Small Jaw in width and height, yet it had a longer active blade and larger jaw aperture. Device temperatures were not different after application, but thermal spread (tissue temperature above 50°C) was 78% greater for Small Jaw (9.6 mm) than for Focus+ (5.4 mm). Burst pressures of sealed vessels were not significantly different between the devices: 900 (±466) mmHg for Focus+ versus 974 (±500) mmHg for Small Jaw. Small Jaw had a shorter individual transection time (5.0 seconds compared to 6.3 seconds for Focus+), whereas Focus+ had 70% less tissue sticking. Thermal damage, neural inflammation, and impaired axonal transport were all significantly lower for Focus+ compared to Small Jaw, by 19%, 57%, and 50%, respectively. Conclusion: With the addition of Adaptive Tissue Technology, Harmonic Focus+ builds upon the manifold advantages of ultrasonic devices in procedures requiring meticulous dissecting capability. Improvements in energy sensing and controlled delivery produce lower tissue temperatures and less thermal damage, especially critical when working near nerves. Focus+ produces vessel seal strengths equivalent to advanced bipolar devices and, although individual device activations are longer, the reduction in tissue sticking is expected to materially lessen operative time in clinical practice.
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