Experimental and numerical study of solid needle insertions into human stomach tissue.

Purpose: Oral drug delivery is the Holy Grail in the field of drug delivery. However, poor bioavailability limits the oral intake of macromolecular drugs. Oral devices may overcome this limitation, but a knowledge gap exists on the device-tissue interaction. This study focuses on needle insertion into the human stomach experimentally and numerically. This will guide early stages of device development.

Methods: Needle insertions were done into excised human gastric tissue with sharp and blunt needles at velocities of 0.0001 and 0.1 m/s. Parameters for constitutive models were determined from tensile visco-hyperelastic biomechanical tests. The computational setup modeled four different needle shape indentations at five velocities from 0.0001 to 5 m/s.

Results: From experiments, peak forces at 0.1 and 0.0001 m/s were 0.995 ± 0.296 N and 1.281 ± 0.670 N (blunt needle) and 0.325 ± 0.235 N and 0.362 ± 0.119 N (sharp needle). The needle geometry significantly influenced peak forces (p < 0.05). A Yeoh-Prony series combination was fitted to the tensile visco-hyperelastic biomechanical data and used for the numerical model with excellent fit (R = 0.973). Both needle geometry and insertion velocity influenced the stress contour and displacement magnitudes as well as energy curves.

Conclusion: This study contributes to a better understanding of needle insertion into the stomach wall. The numerical model demonstrated agreement with experimental data providing a good approach to early device iterations. Findings in this study showed that insertion velocity and needle shape affect tissue mechanical outcomes.