Design and evaluation of a novel biopsy needle with hemostatic function

Abstract

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.

Key words： cancer diagnosis; biopsy needle; hemostatic function; predictive model; coupled Eulerian−Lagrangian

Nomenclature

Abbreviations
CEL	Coupled Eulerian–Lagrangian
FEA	Finite element analysis
ID	Inner diameter
OD	Outer diameter
Variables
C10	Shear modulus of the tissue
En	Young’s modulus of the needle
f	Frictional resistance
g1, g2	Relaxation moduli of parts 1 and 2, respectively
G0	Relaxation modulus G(t) evaluated in t = 0
Gi	Relaxation modulus G(t) evaluated in t = τi
G(t)	Relaxation modulus
J	Elastic volume ratio
k	Bulk modulus
K	Stiffness coefficient of spring A
m	Mass of the slider and inner needle
p	Hydrostatic pressure
t	Cutting time
v	Cutting velocity
W	Strain energy density
x	Displacement of slider
μ	Shear modulus
λi	Shield gravity
σ	Nominal stress
σi	Nominal stress component
ε	Principal stain
εi	Principal stain component
νn	Poisson’s ratio of the needle
ρn	Density of the needle
ρt	Density of the tissue
τi (i = 1,2)	Relaxation time

Acknowledgements

This work was partially supported by Shenzhen Key Laboratory of Robotics Perception and Intelligence (Southern University of Science and Technology, China) (Grant No. ZDSYS20200810171800001).

Conflict of Interest

Authors declare no conflict of interest regarding the submitted manuscript.

References

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