Ushimaru Yuki, Shibamoto Shohei, Yamamoto Kazuyoshi, Yanagimoto Yoshitomo, Ban Namiko, Tagi Nobuaki, Hosaka Makoto, Gotohda Naoto, Eguchi Hidetoshi, Doki Yuichiro, Nakajima Kiyokazu
Department of Next Generation Endoscopic Intervention (Project ENGINE), Graduate School of Medicine, The University of Osaka, Suite 0802, BioSystems Bldg., 1-3, Yamadaoka, Suita, Osaka, 565-0871, Japan.
Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.
Surg Endosc. 2025 Sep 10. doi: 10.1007/s00464-025-12138-w.
Rigid suction-coagulation probes constrain the wrist-like articulation that is central to robotic surgery. We therefore designed a 5-mm single-use flexible suction ball coagulator (flex-SBC) with a modified core design to restore dexterity and assessed its mechanical performance and early clinical feasibility, including the effect of the common robotic gripping strategies on suction flow.
Preclinical. The new 7 × 7 core embedded in silicone was compared with the conventional 1 × 7 core design. Shaft pliability was quantified by sagging displacement and rebound force testing. Suction flow at - 20, - 30, and - 40 kPa was measured, and the impact of grip location (electrode base vs silicone shaft) and forceps type (fenestrated or Maryland bipolar) was analyzed statistically.
The flex-SBC was used in 12 consecutive robotic gastrectomies with prospective collection of device performance, adverse events, and surgeon rating on seven-domain via three-point Likert scale.
Preclinical. Adopting the 7 × 7 increased mean sagging displacement from 15.6 ± 1.8 to 39.3 ± 3.2 mm (p < 0.001) and reduced rebound force from 0.288 ± 0.014 to 0.059 ± 0.004 N (p < 0.001). Mean flow rates were 6.76 ± 0.88, 8.87 ± 0.43, and 10.58 ± 0.40 mL/sec at - 20, - 30, and - 40 kPa, respectively-approximately half those of a rigid probe (all p < 0.001) but still exceeding published thresholds for effective evacuation. Gripping the silicone shaft, especially with Maryland forceps, sharply reduced flow (60% reduction; p < 0.0011).
All operations were completed without device-related malfunctions, injuries, or conversions. Of 84 survey ratings, connection setup, suction efficiency, tissue safety, and overall satisfaction were "satisfactory" in 100%; maneuverability was "satisfactory" in 65% and "average" in 35%. No "unsatisfactory" scores were recorded.
The flex-SBC bends where the robot bends, enabling safe, practical use across robot-assisted upper-GI surgery. Grip technique influences device performance, providing important implications training. Larger comparative trials should clarify whether these ergonomic gains translate into shorter operating times and improved oncologic precision.
刚性吸引-凝血探头限制了对机器人手术至关重要的腕式关节活动。因此，我们设计了一种5毫米一次性使用的柔性吸引球凝血器（flex-SBC），采用改良的芯部设计以恢复灵活性，并评估其机械性能和早期临床可行性，包括常见机器人抓持策略对吸引流的影响。
临床前研究。将嵌入硅胶的新型7×7芯部与传统的1×7芯部设计进行比较。通过下垂位移和回弹力测试对轴的柔韧性进行量化。测量-20、-30和-40千帕时的吸引流，并对抓持位置（电极基部与硅胶轴）和镊子类型（有孔或马里兰双极）的影响进行统计学分析。
在连续12例机器人胃癌切除术中使用flex-SBC，前瞻性收集设备性能、不良事件以及外科医生通过三点李克特量表对七个领域的评分。
临床前研究。采用7×7芯部使平均下垂位移从15.6±1.8毫米增加到39.3±3.2毫米（p<0.001），回弹力从0.288±0.014牛降低到0.059±0.004牛（p<0.001）。在-20、-30和-40千帕时的平均流速分别为6.76±0.88、8.87±0.43和10.58±0.40毫升/秒，约为刚性探头的一半（所有p<0.001），但仍超过有效排空的公布阈值。抓持硅胶轴，尤其是使用马里兰镊子时，会使流速大幅降低（降低60%；p<0.0011）。
所有手术均顺利完成，无与设备相关的故障、损伤或中转情况。在84项调查评分中，连接设置、吸引效率、组织安全性和总体满意度的“满意”率均为100%；可操作性“满意”率为65%，“一般”率为35%。未记录到“不满意”评分。
flex-SBC在机器人弯曲的部位弯曲，可在机器人辅助的上消化道手术中安全、实际地使用。抓持技术会影响设备性能，对培训具有重要意义。更大规模的对比试验应阐明这些人体工程学优势是否能转化为更短的手术时间和更高的肿瘤学精准度。
