Purpose

The introduction of novel endoscopic instruments is essential to reduce trauma in visceral surgery. However, endoscopic device development is hampered by challenges in respecting the dimensional restrictions, due to the narrow access route, and by achieving adequate force transmission. As the overall goal of our research is the development of a patient adaptable, endoscopic anastomosis manipulator, biomechanical and size-related characterization of gastrointestinal organs are needed to determine technical requirements and thresholds to define functional design and load-compatible dimensioning of devices.

Methods

We built an experimental setup to measure colon tissue compression piercing forces. We tested 54 parameter sets, including variations of three tissue fixation configurations, three piercing body configurations (four, eight, twelve spikes) and insertion trajectories of constant velocities (5 mms⁻¹, 10 mms⁻¹,15 mms⁻¹) and constant accelerations (5 mms⁻², 10 mms⁻², 15 mms⁻²) each in 5 samples. Furthermore, anatomical parameters (lumen diameter, tissue thickness) were recorded.

Results

There was no statistically significant difference in insertion forces neither between the trajectory groups, nor for variation of tissue fixation configurations. However, we observed a statistically significant increase in insertion forces for increasing number of spikes. The maximum mean peak forces for four, eight and twelve spikes were 6.4 ± 1.5 N, 13.6 ± 1.4 N and 21.7 ± 5.8 N, respectively. The 5th percentile of specimen lumen diameters and pierced tissue thickness were 24.1 mm and 2.8 mm, and the 95th percentiles 40.1 mm and 4.8 mm, respectively.

Conclusion

The setup enabled reliable biomechanical characterization of colon material, on the base of which design specifications for an endoscopic anastomosis device were derived. The axial implant closure unit must enable axial force transmission of at least 28 N (22 ± 6 N). Implant and applicator diameters must cover a range between 24 and 40 mm, and the implant gap, compressing anastomosed tissue, between 2 and 5 mm.

中文翻译：

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用于结直肠加压吻合术的测力装置的设计和首次离体结果

目的

新型内窥镜器械的引入对于减少内脏手术的创伤至关重要。然而，内窥镜设备的开发受到尺寸限制方面的挑战、由于狭窄的进入路径以及实现足够的力传递而受到阻碍。由于我们研究的总体目标是开发适合患者的内窥镜吻合机械手，因此需要对胃肠器官进行生物力学和尺寸相关的表征，以确定技术要求和阈值，以定义设备的功能设计和负载兼容尺寸。

方法

我们建立了一个实验装置来测量结肠组织压缩穿刺力。我们测试了 54 个参数集，包括三种组织固定配置、三种穿刺体配置（四个、八个、十二个尖刺）和恒定速度（5 mms ^-1、10 mms ^-1、15 mms ^-1）和恒定速度的插入轨迹的变化5 个样本中的每个加速度（5 mms ^-2、10 mms ^-2、15 mms ^{-2 ）。}此外，还记录了解剖参数（管腔直径、组织厚度）。

结果

轨迹组之间的插入力和组织固定配置的变化都没有统计学上的显着差异。然而，我们观察到随着尖峰数量的增加，插入力在统计学上显着增加。四个、八个和十二个尖峰的最大平均峰值力分别为 6.4 ± 1.5 N、13.6 ± 1.4 N 和 21.7 ± 5.8 N。标本管腔直径和穿刺组织厚度的第 5 个百分位数分别为 24.1 毫米和 2.8 毫米，第 95 个百分位数分别为 40.1 毫米和 4.8 毫米。

结论

该装置能够对结肠材料进行可靠的生物力学表征，并在此基础上推导出内窥镜吻合装置的设计规范。轴向种植体闭合单元必须能够传递至少 28 N (22 ± 6 N) 的轴向力。种植体和施药器的直径必须覆盖 24 到 40 毫米之间的范围，以及压缩吻合组织的种植体间隙在 2 到 5 毫米之间。