BMC Surgery (Feb 2022)
Novel multifunctional robotically assisted bipolar instrument for simultaneous radiofrequency sealing and transection: preclinical and single-center experience
Abstract
Abstract Background A novel robotic-assisted bipolar radiofrequency (RF) multifunctional vessel seal-and-transection instrument (SynchroSeal, Intuitive Surgical, Inc., Sunnyvale, CA) has been developed. The objective of the current paper is to describe the design of SynchroSeal based on bench studies, assess the safety of SynchroSeal in ex vivo and in vivo porcine studies, and provide early clinical context. Methods SynchroSeal grasping, energy activation time, and jaw temperature were evaluated with those of the Harmonic Ace+7. Data were analyzed with descriptive statistics, with Mann–Whitney for comparisons and statistical significance p < 0.05. Ex vivo and in vivo animal safety assessments of tissue after SynchroSeal use were evaluated for burst pressure, thermal spread, and acute sealing. Last, a single-center analysis of the technical metrics of SynchroSeal and Vessel Sealer Extend (robotically assisted seal-and-transection instrument) in bariatric cases is provided. Results Bench studies of SynchroSeal and Harmonic Ace+7 evidenced SynchroSeal’s greater slip resistance force (8.4 ± 1.0 vs. 3.1 ± 0.4 N; p = 0.0002), lower grip pressure (3.0 ± 0.2 vs. 4.2 ± 0.5 kg/cm2; p = 0.0002), faster seal time (1.5 ± 0.4 vs. 11.6 ± 2.5 s; p < 0.0001), lower mean jaw temperature (109.7 ± 7.2 vs. 247.4 ± 8.6 °C; p = 0.0051), and faster cooling to 40 °C (53.6 ± 2.1 vs. 68.0 ± 3.5 s; p = 0.0051). SynchroSeal’s mean burst pressures after seal-and-transection and seal only modes were, respectively, 1169.1 ± 393.1 mmHg and 1159.2 ± 454.6 mmHg. Mean thermal spreads were, respectively, 1.2 ± 0.6 mm and 1.5 ± 0.55 mm. In the chronic animal study, 102 vessels were sealed; at 3 weeks post-procedure, there was no evidence of leakage or adverse events, such as non-target tissue thermal spread or tissue damage. In bariatrics cases, SynchroSeal was activated more frequently per case; however, its mean activation time was significantly shorter than Vessel Sealer Extend. No adverse events were reported for either device. Conclusions SynchroSeal’s multifunctional design provides enhanced sealing and transection capabilities with an acceptable safety profile.
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