Design and evaluation of a novel biopsy needle with hemostatic function

Biopsy is a method commonly used for early cancer diagnosis. However, bleeding complications of widely available biopsy are risky for patients. Safer biopsy will result in a more accurate cancer diagnosis and a decrease in the risk of complications. In this article, we propose a novel biopsy needle that can reduce bleeding during biopsy procedures and achieve stable hemostasis. The proposed biopsy needle features a compact structure and can be operated easily by left and right hands. A predictive model for puncture force and tip deflection based on coupled Eulerian–Lagrangian (CEL) method is developed. Experimental results show that the biopsy needle can smoothly deliver the gelatin sponge hemostatic plug into the tissue. Although the hemostatic plug bends, the overall delivery process is stable, and the hemostatic plug retains in the tissue without being affected by the withdrawal of the needle. Further experiments indicate that the specimens are well obtained and evenly distributed in the groove of the outer needle without scattering. Our proposed design of biopsy needle possesses strong ability of hemostasis, tissue cutting, and tissue retention. The CEL model accurately predicts the peak of puncture force and produces close estimation of the insertion force at the postpuncture stage and tip position.