通讯作者: 马宏昌, mahc860428@gmail.com

DOI：10.12201/bmr.202610.00026

Bench Testing of the 8 N Anti-Slippage Specification at the Handle–Shaft Locking Interface of Multi-Articulating Laparoscopic Instruments

• 摘要：背景：多关节腹腔镜器械需要可靠的手柄与杆之间的机械连接，以在手术操作过程中保持器械的预定构型。手柄–杆锁紧界面应在外部载荷作用下抵抗非预期的相对位移。然而，某一特定抗滑移阈值的合理性必须结合器械设计及预期使用条件加以评估。 目的：采用受控台架模型，评价多关节腹腔镜器械锁定状态下手柄–杆界面 8 N 抗滑移规范的机械性能。 方法：基于待测器械、机械固定夹具、经校准的测力仪及位移测量设备，设计了一套台架式机械评价方法。在手柄–杆锁紧机构接合后，施加外部力以评估其抗相对位移能力。测试项目包括轴向加载、相关横向方向加载以及反复锁紧–解锁循环。主要结局指标为锁定界面发生相对滑移起始时所对应的力。次要结局指标包括载荷下的位移、锁紧完全失效以及反复操作后机械性能的变化。验收标准应在确认性试验前预先确定。 结果：三个批次的 30 件器械均满足 8 N 轴向要求（30/30）。轴向滑移起始力为 12.40 ± 0.97 N（范围 10.80–14.00 N）。在 8 N、60 s 持续载荷下，平均相对位移由 0.06 mm 增大至 0.10 mm，平均残余位移为 0.02 mm。经过 1 000 次循环后，轴向滑移起始力为 12.00 ± 0.97 N（范围 10.40–13.60 N）。 结论：本研究为评估多关节腹腔镜器械手柄–杆锁紧界面 8 N 抗滑移规范提供了一套台架测试框架。该规范能否提供足够的机械稳定性，须将测得性能与基于器械预期使用及可预见载荷条件预先设定的工程验收标准进行比较后方可判定。

  关键词： 多关节腹腔镜器械; 手柄–杆界面; 锁紧机构; 抗滑移; 机械验证; 台架测试; 微创外科。

   

  Abstract: Background: Multi-articulating laparoscopic instruments require a reliable mechanical connection between the handle and shaft to maintain the intended instrument configuration during surgical procedures. The handle–shaft locking interface should resist unintended relative displacement under external loading. However, the appropriateness of a specific anti-slip threshold must be evaluated in the context of the instrument design and its intended conditions of use. Objective: To evaluate the mechanical performance of an 8 N anti-slip specification for the handle–shaft interface of multi-articulating laparoscopic instruments in the locked state using a controlled bench-top model. Methods: A bench-top mechanical evaluation method was developed using the test instruments, a mechanical fixation fixture, a calibrated force gauge, and displacement measurement equipment. After engagement of the handle–shaft locking mechanism, external forces were applied to assess its resistance to relative displacement. Test procedures included axial loading, loading in relevant transverse directions, and repeated locking–unlocking cycles. The primary outcome measure was the force at the onset of relative slippage at the locking interface. Secondary outcome measures included displacement under load, complete locking failure, and changes in mechanical performance following repeated operation. Acceptance criteria should be predefined before confirmatory testing. Results: All 30 instruments from three batches met the 8 N axial requirement (30/30). The axial slip-onset force was 12.40 ± 0.97 N (range: 10.80–14.00 N). Under a sustained load of 8 N for 60 s, the mean relative displacement increased from 0.06 mm to 0.10 mm, with a mean residual displacement of 0.02 mm. After 1,000 cycles, the axial slip-onset force was 12.00 ± 0.97 N (range: 10.40–13.60 N). Conclusion: This study provides a bench-testing framework for evaluating the 8 N anti-slip specification at the handle–shaft locking interface of multi-articulating laparoscopic instruments. Whether this specification provides adequate mechanical stability can only be determined by comparing the measured performance against engineering acceptance criteria predefined on the basis of the instrument's intended use and foreseeable loading conditions.

  Key words: Multi-articulating laparoscopic instruments; handle–shaft interface; locking mechanism; anti-slip resistance; mechanical verification; bench testing; minimally invasive surgery.

  提交时间：2026-10-28

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• 序号	提交日期	编号	操作
  1	2026-10-12	10.12201/bmr.202610.00026V1	下载

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