Clinical Development Engineering, Intuitive Surgical, Inc., Sunnyvale, CA, USA.
New Product Development, Advanced Energy Instruments, Intuitive Surgical, Inc., Sunnyvale, CA, USA.
BMC Surg. 2022 Feb 2;22(1):37. doi: 10.1186/s12893-022-01483-5.
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.
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.
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/cm; 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.
SynchroSeal's multifunctional design provides enhanced sealing and transection capabilities with an acceptable safety profile.
一种新型的机器人辅助双极射频（RF）多功能血管密封-切割仪器（SynchroSeal，直觉外科公司，加利福尼亚州森尼韦尔）已经研发出来。本文的目的是描述基于台式研究的 SynchroSeal 的设计，评估 SynchroSeal 在离体和体内猪研究中的安全性，并提供早期的临床背景。
评估了 SynchroSeal 的抓握力、能量激活时间和钳口温度，并与 Harmonic Ace+7 进行了比较。采用描述性统计分析数据，采用 Mann-Whitney 进行比较和统计学意义 p<0.05。评估了 SynchroSeal 使用后的组织的离体和体内动物安全性，包括爆裂压力、热扩散和急性密封。最后，提供了单中心分析 SynchroSeal 和血管密封器扩展（机器人辅助密封-切割仪器）在减重手术中的技术指标。
SynchroSeal 和 Harmonic Ace+7 的台式研究表明，SynchroSeal 的抗滑阻力更大（8.4±1.0 与 3.1±0.4 N；p=0.0002），握持压力更低（3.0±0.2 与 4.2±0.5 kg/cm；p=0.0002），密封时间更快（1.5±0.4 与 11.6±2.5 s；p<0.0001），钳口平均温度更低（109.7±7.2 与 247.4±8.6°C；p=0.0051），冷却到 40°C 的速度更快（53.6±2.1 与 68.0±3.5 s；p=0.0051）。SynchroSeal 在密封-切割和仅密封模式下的平均爆裂压力分别为 1169.1±393.1 mmHg 和 1159.2±454.6 mmHg。平均热扩散分别为 1.2±0.6 mm 和 1.5±0.55 mm。在慢性动物研究中，102 个血管被密封；在术后 3 周时，没有证据表明有泄漏或不良事件，如非目标组织热扩散或组织损伤。在减重手术病例中，SynchroSeal 每个病例的激活频率更高；然而，其平均激活时间明显短于血管密封器扩展。两种设备均未报告不良事件。
SynchroSeal 的多功能设计提供了增强的密封和切割能力，具有可接受的安全性。
