Abstract
Abstract
Background
Articulated laparoscopic instruments require a reliable mechanical connection between the handle and shaft to maintain the intended instrument configuration during surgical manipulation. The handle–shaft locking interface should resist unintended relative displacement under external loading. However, the appropriateness of a specific slip-resistance threshold must be evaluated in relation to the instrument design and intended conditions of use.
Objective
To evaluate the mechanical performance associated with an 8 N slip-resistance specification for the locked handle–shaft interface of an articulated laparoscopic instrument using a controlled bench model.
Methods
A bench-based mechanical evaluation method was designed using the instrument under test, mechanical fixtures, a calibrated force-measurement device, and displacement-measurement equipment. After engagement of the handle–shaft locking mechanism, external forces were applied to evaluate resistance to relative displacement. Testing included axial loading, loading in relevant transverse directions, and repeated locking–unlocking cycles. The primary outcome was the force corresponding to the onset of relative slippage at the locked interface. Secondary outcomes included displacement under load, complete locking failure, and changes in mechanical performance after repeated operation. Acceptance criteria should be established before confirmatory testing.
Results
All 30 instruments from three production 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, mean relative displacement increased from 0.06 mm to 0.10 mm, and mean residual displacement was 0.02 mm. After 1,000 cycles, the axial slip-onset force was 12.00 ± 0.97 N (range, 10.40–13.60 N).
Conclusions
This study provides a bench-testing framework for evaluating an 8 N slip-resistance specification for the handle–shaft locking interface of an articulated laparoscopic instrument. Whether this specification provides adequate mechanical stability can be determined only by comparing the measured performance with engineering acceptance criteria established in advance on the basis of the instrument’s intended use and foreseeable loading conditions.