• 国家药监局综合司 国家卫生健康委办公厅
  • 国家药监局综合司 国家卫生健康委办公厅

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

Corresponding author: Hongchang Ma, mahc860428@gmail.com
DOI: 10.12201/bmr.202610.00026
Statement: This article is a preprint and has not been peer-reviewed. It reports new research that has yet to be evaluated and so should not be used to guide clinical practice.
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    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.

    Submit time: 28 October 2026

    Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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  • ID Submit time Number Download
    1 2026-10-12

    10.12201/bmr.202610.00026V1

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Hongchang Ma. Bench Testing of the 8 N Anti-Slippage Specification at the Handle–Shaft Locking Interface of Multi-Articulating Laparoscopic Instruments. 2026. biomedRxiv.202610.00026

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