An Automatic Needle Biopsy Sampling Device With Enhanced Tissue Penetration and Precision Sampling
Shengzhe Zhao, Xingfeng Xu, Qingshen Meng, Jiajun Wei, Wenguang Shama, Yanyan Zhang, Dongjun Zhao, Siyang Zuo, Jie Zhang · Journal of Medical Devices · 2025
Abstract Incidence rates of thyroid cancer have been rising annually worldwide over the past two decades, establishing it as one of the most rapidly increasing malignant tumors. Ultrasound-guided fine-needle aspiration biopsy (US-FNAB) continues to be regarded as the diagnostic gold standard but faces significant limitations due to its dependence on the physician's clinical expertise. This study introduces a novel automatic thyroid biopsy device designed to enhance operability and increase the sampling success rate in needle biopsies. The proposed device incorporates reciprocating motion along the needle axis, needle rotation, and automatic sampling, thereby facilitating smooth tissue penetration and efficient sample acquisition. Experiments evaluating rotational speed and automatic sampling were performed to determine the optimal operating parameters of the automatic biopsy device. Puncture experiments on ex vivo tissues demonstrated that the device significantly enhances puncture efficiency and operability. In the in vivo validation, comparison with a conventional fine-needle syringe demonstrated that the device reduces the operational difficulty and improves sampling effectiveness in clinical applications. The proposed device offers a novel and practical solution that addresses key limitations of conventional fine-needle aspiration biopsy, with promising implications for reliable thyroid cancer diagnosis.