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Novel clip applicator for minimally invasive surgery

机译：新型夹子涂抹器，用于微创手术

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BackgroundLigation clips are used ubiquitously throughout minimally invasive surgery for apposition of tissues. Their size limits their application beyond ligation of small tubular structures. A novel clip and clip applicator that allows for broad-area clamping and rotation has been developed by our team. The primary aim of this study is to provide preliminary data assessing tensile strength of the clip across apposed segments of bowel.MethodsA comparative study evaluating the maximum load (N) held across two apposed tissues by (a) our novel broad-area clip and (b) a conventional commercial clip was performed. Two sections of porcine bowel were clamped together and the maximum load (N) was measured using a tensile strength material testing machine. A preliminary experiment comparing staple line leak pressures in a porcine modelclip enforcement of staple line was also conducted. p<0.05 determined statistical significance.ResultsTwenty-four samples (intervention=15; control=9) of porcine bowel annealed by surgical clips were tested. The mean maximum force withheld by the bowel and staples was greater for our novel clip design (2.043 +/- 0.831N) than the control clip (1.080 +/- 0.466N, p=0.004). Ten staple line (intervention=5; control=5) pressures of porcine bowel were measured. There was no statistically significant difference between the leak pressures with clip reinforcement (84.8mmHg; range 71.8-109.8mmHg), or without (54.1mmHg; range 26.3-98.9mmHg).Conclusion These preliminary results suggest that our novel clip is able to withstand higher tensile force across tissues compared to a leading commercial clip. A small preliminary trial of effect on leak pressures demonstrated no statistical significance; however, increasing reliability of staple line deformation may be a clinically important finding. Whilst further iteration of product design and clinical testing is required, this product may occupy an important clinical niche through staple line reinforcement, enterotomy closure and other applications.
机译：背景抑制夹在整个微创手术中普遍存在，以便与组织的配位。它们的尺寸限制了它们的应用，超越了对小管状结构的结扎。我们的团队开发了一种新颖的夹子和夹子涂抹器，其允许广泛的夹紧和旋转。本研究的主要目的是提供术语评估横跨肠道的夹子的拉伸强度的初步数据。方法对比较研究评估通过（a）我们的新型广域夹和（ b）进行常规的商业夹。将猪肠的两部分夹在一起，使用拉伸强度材料试验机测量最大载荷（n）。还进行了初步实验，比较猪纤维漏气压力在猪型模板上的寄生线上的强制执行。 P <0.05确定的统计学显着性。通过手术夹子退火的猪肠（Snollow = 15; Control = 9）进行猪肠道肠道的统计学意义。我们的新型夹子设计（2.043 +/- 0.831N）比对照夹（1.080 +/- 0.466N，P = 0.004）更大，所以肠道和钉的平均最大力更大。测量了十个钉线（干预= 5;对照= 5）猪肠的压力。夹子加固（84.8mmHg;范围为71.8-109.8mmHg），或没有（54.1mmhg;范围26.3-98.9mmhg）之间没有统计学上有显着差异。结论这些初步结果表明我们的新颖剪辑能够承受与领先的商业夹子相比，跨组织的较高拉力。对泄漏压力影响的小初步试验表明无统计学意义;然而，增加钉线变形的可靠性可能是临床重要的发现。如果需要进一步迭代产品设计和临床测试，则该产品可以通过短纤维钢筋，肠球闭合和其他应用占据重要的临床基础。

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