This article introduces a specialized tester designed to evaluate the anchoring strength of guide needles in medical devices, critical for ensuring secure placement during minimally invasive procedures. The system measures the force required to dislodge needles under simulated clinical conditions, complying with international medical device standards.

Applicable Standards

Main Parameters

• Anchor Force Range: 0-50N (resolution 0.01N)
• Pull-Out Speed: 5-50 mm/min (programmable profiles)
• Cycle Repeats: 1-100 tests (customizable)
• Data Output: Digital force-displacement graphs with statistical analysis

Working Principle

The tester employs a motorized tensile stage to apply controlled pull-out forces to guide needles inserted into simulated tissue matrices. A load cell measures the maximum force before dislodgement while a high-precision encoder tracks displacement. Thermal controls maintain testing temperatures within physiological ranges.

Test Principles

1. Static Anchor Testing: Measures initial dislodgement resistance
2. Dynamic Pull-Out Analysis: Evaluates force under continuous loading
3. Cyclic Fatigue Simulation: Assesses retention after repeated insertions

This integrated solution enables manufacturers to optimize needle designs for enhanced anchoring performance, meeting FDA 510(k) submission requirements while improving clinician confidence through precise retention characterization.