Synthetic Tissue Phantom for Validation of Core-Needle Biopsy Devices

Abstract

Validation of core needle biopsy (CNB) devices currently relies on the use of fresh porcine tissue (shoulder, kidney, and connective tissue) which presents significant drawbacks for laboratory testing. Biological tissues inherently vary in mechanical properties and decay rapidly over time leading to inconsistent results, leaving room for improved test evaluation models. To address these challenges, this project focuses on developing a synthetic tissue phantom that researchers can use to replace porcine tissue for the validation process. The phantom is designed to directly replicate the key mechanical and structural properties of the target animal tissues, while improving reproducibility, shelf life, degradability, and durability. It is engineered using a polymer-based matrix with adjustable crosslinking to accurately mimic tissue stiffness, viscoelastic response, and authentic needle–tissue interactions during penetration, cutting, and core retrieval. This design allows customization to match different tissue types ensuring consistent testing conditions. Stability, resistance to handling, and minimal batch-to-batch variability are prioritized to maintain consistency throughout repeated passes. The phantom is optimized for cost-effective, scalable production using commercially available polymers and a straightforward fabrication process. Sterilization compatibility supports regulatory requirements, while consistent material formulation ensures reproducible batches. Our phantom has succeeded at replicating force curves and contiguity scoring of porcine muscle and kidney. This supports device development, improved procedural training, and reduced animal tissue use, ultimately contributing to more effective diagnostic procedures. With continued refinement, this medium has the potential to become a standard tool for validation in research and clinical environments that need alternative phantoms to model human tissue.

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