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.

Graphical abstract

Keywords

cancer diagnosis / biopsy needle / hemostatic function / predictive model / coupled Eulerian−Lagrangian

References

[1] Fitzmaurice C , Dicker D , Pain A , Hamavid H , Moradi-Lakeh M , MacIntyre M F , Allen C , Hansen G , Woodbrook R , Wolfe C , Hamadeh R R , Moore A , Werdecker A , Gessner B D , Te Ao B , McMahon B , Karimkhani C , Yu C H , Cooke G S , Schwebel D C , Carpenter D O , Pereira D M , Nash D , Kazi D S , De Leo D , Plass D , Ukwaja K N , Thurston G D , Jin K Y , Simard E P , Mills E , Park E K , Catalá-López F , deVeber G , Gotay C , Khan G , Hosgood H D III , Santos I S , Leasher J L , Singh J , Leigh J , Jonas J B , Sanabria J , Beardsley J , Jacobsen K H , Takahashi K , Franklin R C , Ronfani L , Montico M , Naldi L , Tonelli M , Geleijnse J , Petzold M , Shrime M G , Younis M , Yonemoto N , Breitborde N , Yip P , Pourmalek F , Lotufo P A , Esteghamati A , Hankey G J , Ali R , Lunevicius R , Malekzadeh R , Dellavalle R , Weintraub R , Lucas R , Hay R , Rojas-Rueda D , Westerman R , Sepanlou S G , Nolte S , Patten S , Weichenthal S , Abera S F , Fereshtehnejad S M , Shiue I , Driscoll T , Vasankari T , Alsharif U , Rahimi-Movaghar V , Vlassov V V , Marcenes W S , Mekonnen W , Melaku Y A , Yano Y , Artaman A , Campos I , MacLachlan J , Mueller U , Kim D , Trillini M , Eshrati B , Williams H C , Shibuya K , Dandona R , Murthy K , Cowie B , Amare A T , Antonio C A , Castañeda-Orjuela C , van Gool C H , Violante F , Oh I H , Deribe K , Soreide K , Knibbs L , Kereselidze M , Green M , Cardenas R , Roy N , Tillmann T , Li Y M , Krueger H , Monasta L , Dey S , Sheikhbahaei S , Hafezi-Nejad N , Kumar G A , Sreeramareddy C T , Dandona L , Wang H D , Vollset S E , Mokdad A , Salomon J A , Lozano R , Vos T , Forouzanfar M , Lopez A , Murray C , Naghavi M . The global burden of cancer 2013. JAMA Oncology, 2015, 1(4): 505–527

[2] Burgard C , Stahl R , de Figueiredo G N , Dinkel J , Liebig T , Cioni D , Neri E , Trumm C G . Percutaneous CT fluoroscopy-guided core needle biopsy of mediastinal masses: technical outcome and complications of 155 procedures during a 10-year period. Diagnostics, 2021, 11(5): 781

[3] James T W , Baron T H . A comprehensive review of endoscopic ultrasound core biopsy needles. Expert Review of Medical Devices, 2018, 15(2): 127–135

[4] TanisakaYMizuideMFujitaAOgawaTArakiRSuzukiMKatsudaHSaitoYMiyaguchiKTashimaTMashimoYYasudaMRyozawaS. Comparison of endoscopic ultrasound-guided fine-needle aspiration and biopsy device for lymphadenopathy. Gastroenterology Research and Practice, 2021, 6640862

[5] Kurita A , Yasukawa S , Zen Y , Yoshimura K , Ogura T , Ozawa E , Okabe Y , Asada M , Nebiki H , Shigekawa M , Ikeura T , Eguchi T , Maruyama H , Ueki T , Itonaga M , Hashimoto S , Shiomi H , Minami R , Hoki N , Takenaka M , Itokawa Y , Uza N , Hashigo S , Yasuda H , Takada R , Kamada H , Kawamoto H , Kawakami H , Moriyama I , Fujita K , Matsumoto H , Hanada K , Takemura T , Yazumi S . Comparison of a 22-gauge franseen-tip needle with a 20-gauge forward-bevel needle for the diagnosis of type 1 autoimmune pancreatitis: a prospective, randomized, controlled, multicenter study (COMPAS study). Gastrointestinal Endoscopy, 2020, 91(2): 373–381

[6] Ashat M , Klair J S , Rooney S L , Vishal S J , Jensen C , Sahar N , Murali A R , El-Abiad R , Gerke H . Randomized controlled trial comparing the franseen needle with the fork-tip needle for EUS-guided fine-needle biopsy. Gastrointestinal Endoscopy, 2021, 93(1): 140–150

[7] Hedenström P , Demir A , Khodakaram K , Nilsson O , Sadik R . EUS-guided reverse bevel fine-needle biopsy sampling and open tip fine-needle aspiration in solid pancreatic lesions—a prospective, comparative study. Scandinavian Journal of Gastroenterology, 2018, 53(2): 231–237

[8] de Jong T L , Pluymen L H , van Gerwen D J , Kleinrensink G J , Dankelman J , van den Dobbelsteen J J . PVA matches human liver in needle-tissue interaction. Journal of the Mechanical Behavior of Biomedical Materials, 2017, 69: 223–228

[9] Mukai S , Itoi T , Yamaguchi H , Sofuni A , Tsuchiya T , Tanaka R , Tonozuka R , Honjo M , Fujita M , Yamamoto K , Matsunami Y , Asai Y , Kurosawa T , Nagakawa Y . A retrospective histological comparison of EUS-guided fine-needle biopsy using a novel franseen needle and a conventional end-cut type needle. Endoscopic Ultrasound, 2019, 8(1): 50–57

[10] Eiro M , Katoh T , Watanabe T . Risk factors for bleeding complications in percutaneous renal biopsy. Clinical and Experimental Nephrology, 2005, 9(1): 40–45

[11] Csukas D , Urbanics R , Moritz A , Ellis-Behnke R . AC5 Surgical Hemostat^TM as an effective hemostatic agent in an anticoagulated rat liver punch biopsy model. Nanomedicine: Nanotechnology, Biology, and Medicine, 2015, 11(8): 2025–2031

[12] Lyle M A , Dean D S . Ultrasound-guided fine-needle aspiration biopsy of thyroid nodules in patients taking novel oral anticoagulants. Thyroid, 2015, 25(4): 373–376

[13] Fujita M , Shiotani A , Murao T , Ishii M , Yamanaka Y , Nakato R , Matsumoto H , Tarumi K , Manabe N , Kamada T , Hata J , Haruma K . Safety of gastrointestinal endoscopic biopsy in patients taking antithrombotics. Digestive Endoscopy, 2015, 27(1): 25–29

[14] Deng C X , Dogra V , Exner A A , Wang H S , Bhatt S , Zhou Y , Stowe N T , Haaga J R . A feasibility study of high intensity focused ultrasound for liver biopsy hemostasis. Ultrasound in Medicine & Biology, 2004, 30(11): 1531–1537

[15] Viola F, Mauldin F W, Lin-Schmidt X, Haverstick D M, Lawrence M B, Walker W F. A novel ultrasound-based method to evaluate hemostatic function of whole blood. Clinica Chimica Acta, 2010, 411(1–2): 106–113

[16] Alotaibi M , Shrouder-Henry J , Amaral J , Parra D , Temple M , John P , Connolly B . The positive color Doppler sign post biopsy: effectiveness of US-directed compression in achieving hemostasis. Pediatric Radiology, 2011, 41(3): 362–368

[17] Abdulhak A H, Nichols C S. Stick and move: hemostasis for inpatient punch biopsies. Journal of the American Academy of Dermatology, 2021 (in press)

[18] Rahal Junior A , Falsarella P M , Ferreira V T R , Mariotti G C , de Queiroz M R G , Garcia R G . Injecting hemostatic matrix in the path of biopsies: efficacy, potential complications, and the management of such complications. Radiologia Brasileira, 2018, 51(2): 102–105

[19] Wong P , Johnson K J , Warner R L , Merz S I , Kruger G H , Weitzel W F . Performance of biopsy needle with therapeutic injection system to prevent bleeding complications. Journal of Medical Devices, 2013, 7(1): 011002

[20] Su B Q , Yu S , Yan H , Hu Y D , Buzurovic I , Liu D Y , Liu L L , Teng Y L , Tang J , Wang J C , Liu W Y . Biopsy needle system with a steerable concentric tube and online monitoring of electrical resistivity and insertion forces. IEEE Transactions on Biomedical Engineering, 2021, 68(5): 1702–1713

[21] Lapouge G , Poignet P , Troccaz J . Towards 3D ultrasound guided needle steering robust to uncertainties, noise, and tissue heterogeneity. IEEE Transactions on Biomedical Engineering, 2021, 68(4): 1166–1177

[22] Misra S , Reed K B , Schafer B W , Ramesh K T , Okamura A M . Mechanics of flexible needles robotically steered through soft tissue. International Journal of Robotics Research, 2010, 29(13): 1640–1660

[23] Jushiddi M G , Mani A , Silien C , Tofail S A M , Tiernan P , Mulvihill J J E . A computational multilayer model to simulate hollow needle insertion into biological porcine liver tissue. Acta Biomaterialia, 2021, 136: 389–401

[24] Konh B , Honarvar M , Darvish K , Hutapea P . Simulation and experimental studies in needle–tissue interactions. Journal of Clinical Monitoring and Computing, 2017, 31(4): 861–872

[25] Jiang S , Li P , Yu Y , Liu J , Yang Z Y . Experimental study of needle–tissue interaction forces: effect of needle geometries, insertion methods and tissue characteristics. Journal of Biomechanics, 2014, 47(13): 3344–3353

[26] de la Torre R A , Bachman S L , Wheeler A A , Bartow K N , Scott J S . Hemostasis and hemostatic agents in minimally invasive surgery. Surgery, 2007, 142(4): S39–S45

[27] Balakrishnan B , Soman D , Payanam U , Laurent A , Labarre D , Jayakrishnan A . A novel injectable tissue adhesive based on oxidized dextran and chitosan. Acta Biomaterialia, 2017, 53: 343–354

[28] Tompeck A J , Gajdhar A U R , Dowling M , Johnson S B , Barie P S , Winchell R J , King D , Scalea T M , Britt L D , Narayan M . A comprehensive review of topical hemostatic agents: the good, the bad, and the novel. Journal of Trauma and Acute Care Surgery, 2020, 88(1): e1–e21

[29] Stauffer P R , Rossetto F , Prakash M , Neuman D G , Lee T . Phantom and animal tissues for modelling the electrical properties of human liver. International Journal of Hyperthermia, 2003, 19(1): 89–101

[30] Carter F J , Frank T G , Davies P J , McLean D , Cuschieri A . Measurements and modelling of the compliance of human and porcine organs. Medical Image Analysis, 2001, 5(4): 231–236

[31] Wineman A . Nonlinear viscoelastic solids—a review. Mathematics and Mechanics of Solids, 2009, 14(3): 300–366

[32] Yang J , Yu L T , Wang L , Wang W J , Cui J W . The estimation method of friction in unconfined compression tests of liver tissue. Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine, 2018, 232(6): 573–587

[33] Estermann S J , Pahr D H , Reisinger A . Hyperelastic and viscoelastic characterization of hepatic tissue under uniaxial tension in time and frequency domain. Journal of the Mechanical Behavior of Biomedical Materials, 2020, 112: 104038

[34] Li L , Maccabi A , Abiri A , Juo Y Y , Zhang W Y , Chang Y J , Saddik G N , Jin L H , Grundfest W S , Dutson E P , Eldredge J D , Benharash P , Candler R N . Characterization of perfused and sectioned liver tissue in a full indentation cycle using a visco-hyperelastic model. Journal of the Mechanical Behavior of Biomedical Materials, 2019, 90: 591–603

[35] Liu D , Li G Y , Su C , Zheng Y , Jiang Y X , Qian L X , Cao Y P . Effect of ligation on the viscoelastic properties of liver tissues. Journal of Biomechanics, 2018, 76: 235–240

[36] Zheng Y , Jiang Y X , Cao Y P . A porohyperviscoelastic model for the shear wave elastography of the liver. Journal of the Mechanics and Physics of Solids, 2021, 150: 104339

[37] Nafo W , Al-Mayah A . Measuring the hyperelastic response of porcine liver tissues in-vitro using controlled cavitation rheology. Experimental Mechanics, 2021, 61(2): 445–458

[38] Pasyar P , Masjoodi S , Montazeriani Z , Makkiabadi B . A digital viscoelastic liver phantom for investigation of elastographic measurements. Computers in Biology and Medicine, 2020, 127: 104078

[39] Matin Z , Moghimi Zand M , Salmani Tehrani M , Wendland B R , Dargazany R . A visco-hyperelastic constitutive model of short- and long-term viscous effects on isotropic soft tissues. Proceedings of the Institution of Mechanical Engineers, Part C: Journal of Mechanical Engineering Science, 2020, 234(1): 3–17

[40] Zhang Y D , Li B , Yuan L P . Study on the control method and optimization experiment of prostate soft tissue puncture. IEEE Access: Practical Innovations, Open Solutions, 2020, 8: 218621–218643

[41] Roesthuis R J, van Veen Y R J, Jahya A, Misra S. Mechanics of needle-tissue interaction. In: Proceedings of 2011 IEEE/RSJ International Conference on Intelligent Robots and Systems. San Francisco: IEEE, 2011, 2557–2563

[42] Li A D R , Plott J , Chen L , Montgomery J S , Shih A . Needle deflection and tissue sampling length in needle biopsy. Journal of the Mechanical Behavior of Biomedical Materials, 2020, 104: 103632

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.

RIGHTS & PERMISSIONS

2023 Higher Education Press