带有雷鸟重装系统的埃施朗™+ 订书机与两种商用内窥镜手术订书机临床前性能比较。

IF 1.3 Q4 ENGINEERING, BIOMEDICAL Medical Devices-Evidence and Research Pub Date : 2023-12-05 eCollection Date: 2023-01-01 DOI:10.2147/MDER.S443067
Shanshan Wang, Ying Hua, Jun Liu, Zhifan F Huang, Jeffrey W Clymer, Crystal D Ricketts, Jin Hao
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引用次数: 0

摘要

背景:手术缝合器的设计不断进步,缝合线的形成更加一致,从而提高了泄漏压力,降低了缝合线的泄漏率。本研究比较了带有 Thunderbird 重载装置的 Ethicon Echelon™+ 订书机和另外两种目前可用的商用订书机 Reach Anzhi 和带有相应重载装置的 Fulbright Lunar:通过 CT 扫描确定猪胃(厚度为 3.0-3.3 毫米)中三种订书机的畸形订书率。测量了支气管组织(3.0-3.3 毫米)和结肠(1.3-1.7 毫米)中的缝合线漏气压力,并与这两种组织的标准成功标准进行了比较:结果:在胃组织中,埃施朗+ 的畸形缝合率比其他两种商用缝合器低 90% 以上(p < 0.001)。在支气管中,Echelon+ 的漏气压力比 Reach Anzhi 高 56%(p < 0.001),与 Fulbright Lunar 没有显著差异。在结肠中,Echelon+ 的液体泄漏压力是对比者的两倍多(p < 0.001):埃施朗+订书机与雷鸟重装系统的畸形订书率很低,其订书线在厚组织和薄组织中都能承受很高的漏液压力。需要进行临床研究,以确认这些观察到的优点是否会在实际操作中得到体现。
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A Comparison of the Preclinical Performance of the Echelon™+ Stapler with Thunderbird Reloads to Two Commercial Endoscopic Surgical Staplers.

Background: Design of surgical staplers continues to advance with more consistent staple formation that can lead to higher leak pressures and lower rates of leak along the staple line. This study was performed to compare the Ethicon Echelon™+ Stapler with Thunderbird reloads to two other currently available commercial staplers, Reach Anzhi and Fulbright Lunar with corresponding reloads.

Methods: The rate of malformed staples for three staplers was determined in porcine stomach (3.0-3.3 mm thickness) via CT scanning. Staple line air leak pressures in bronchial tissue (3.0-3.3 mm) and fluid leak pressures in colon (1.3-1.7 mm) were measured and compared to a standard success criterion for both tissues.

Results: The rate of malformed staples in gastric tissue for Echelon+ was more than 90% lower than for the two other commercial staplers (p < 0.001). In bronchus, Echelon+ had 56% higher air leak pressures than Reach Anzhi (p < 0.001) and was not significantly different from Fulbright Lunar. In colon, Echelon+ had over twice the fluid leak pressures of the comparators (p < 0.001).

Conclusion: The Echelon+ Stapler with Thunderbird reloads exhibited a low rate of malformed staples, and its staple lines withstood high leak pressures in both thick and thin tissues. Clinical studies are needed to confirm that these observed benefits carry over into actual practice.

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来源期刊
Medical Devices-Evidence and Research
Medical Devices-Evidence and Research ENGINEERING, BIOMEDICAL-
CiteScore
2.80
自引率
0.00%
发文量
41
审稿时长
16 weeks
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