Investigation of the Penetration Force of Disposable Sterile Needles through Biomedical Textile Surfaces
Received: 5 November 2022 | Revised: 3 December 2022 | Accepted: 4 December 2022 | Online: 5 February 2023
Corresponding author: Mehmet Alp Ilgaz
Abstract
Disposable sterile needles are essential highly consumed medical tools. Medical needles are usually manufactured according to standardized protocols, which currently do not provide the specified minimum tolerance value of the penetration force which strongly depends on needle dimensions, needle cutting edge angle, and the type of the tissue surface to be penetrated. In the present study, experimental measurements were performed according to the ISO 7864 standard to investigate the needle-surface penetration effect via the experimental assessment of the influence of the needle dimensions, cutting edge angle, and three different types of biomedical textiles/artificial tissues (i.e. polyurethane (PU), polypropylene (PP), and artificial leather (AL)) on the penetration force. The results indicate that the smaller the needle's cutting-edge angle, the smaller the penetration force across the target tissue surface. An exponential decaying relationship has been found between the penetration force and the needle diameter/gauge. The results also show that PP provides similar results to other materials that are already included in ISO 7864, and it has a good potential to be accepted as a standardized biomedical textile.
Keywords:
penetration force, sterile needle, biomedical textile, medical device, needle penetrationDownloads
References
V. D. Sree, A. Ardekani, P. Vlachos, and A. B. Tepole, "The biomechanics of autoinjector-skin interactions during dynamic needle insertion," Journal of Biomechanics, vol. 134, Mar. 2022, Art. no. 110995. DOI: https://doi.org/10.1016/j.jbiomech.2022.110995
C. A. Luna, R. Tulcan-Toro, F. Romero, and M. F. Luna, "Measurement of residual volume in spinal needles after spinal anesthesia," Colombian Journal of Anesthesiology, vol. 45, pp. 12–15, Dec. 2017. DOI: https://doi.org/10.1016/j.rcae.2017.08.013
L. Yeo et al., "The Development of the Modern Prostate Biopsy," in Prostate Biopsy, London, UK: IntechOpen, 2011. DOI: https://doi.org/10.5772/28475
C. Eraslan, O. F. K. Koseoglu, N. Meydan, N. Culhaci, and A. Oral, "Comparison of the results of ultrasonography-guided percutaneous liver mass biopsy performed with 18 and 20 gauge needles," Ege Tıp Dergisi, vol. 58, no. 1, pp. 8–12, Mar. 2019.
L. Arendt-Nielsen, H. Egekvist, and P. Bjerring, "Pain following controlled cutaneous insertion of needles with different diameters," Somatosensory & Motor Research, vol. 23, no. 1–2, pp. 37–43, Jan. 2006. DOI: https://doi.org/10.1080/08990220600700925
K. L. Reed, S. F. Malamed, and A. M. Fonner, "Local Anesthesia Part 2: Technical Considerations," Anesthesia Progress, vol. 59, no. 3, pp. 127–137, Oct. 2012. DOI: https://doi.org/10.2344/0003-3006-59.3.127
S. S. Meschi, A. Farghadan, and A. Arzani, "Flow topology and targeted drug delivery in cardiovascular disease," Journal of Biomechanics, vol. 119, Apr. 2021, Art. no. 110307. DOI: https://doi.org/10.1016/j.jbiomech.2021.110307
ANSI ISO 7864:(2016), Sterile Hypodermic Needles for Single Use. Washington, DC, USA: American National Standards Institute, 2016.
BS EN ISO 9626:(2016), Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods. London, UK: British Standards Institution, 2016.
S. Vogels et al., "Measuring intracompartmental pressures for the chronic exertional compartment syndrome: Challenging commercially available devices and their respective accuracy," Journal of Biomechanics, vol. 135, Apr. 2022, Art. no. 111026. DOI: https://doi.org/10.1016/j.jbiomech.2022.111026
C. Yang, Y. Xie, S. Liu, and D. Sun, "Force Modeling, Identification, and Feedback Control of Robot-Assisted Needle Insertion: A Survey of the Literature," Sensors, vol. 18, no. 2, Feb. 2018, Art. no. 561. DOI: https://doi.org/10.3390/s18020561
K. D. Butz et al., "Prestress as an optimal biomechanical parameter for needle penetration," Journal of Biomechanics, vol. 45, no. 7, pp. 1176–1179, Apr. 2012. DOI: https://doi.org/10.1016/j.jbiomech.2012.01.049
E. Busillo and J. S. Colton, "Characterization of Plastic Hypodermic Needles," Journal of Medical Devices, vol. 3, no. 4, Nov. 2009, Art. no. 041004. DOI: https://doi.org/10.1115/1.4000452
M. D. O’Leary, C. Simone, T. Washio, K. Yoshinaka, and A. M. Okamura, "Robotic needle insertion: effects of friction and needle geometry," in International Conference on Robotics and Automation (Cat. No.03CH37422), Taipei, Taiwan, Sep. 2003, vol. 2, pp. 1774–1780 vol.2.
K. Ehmann and K. Malukhin, "A Generalized Analytical Model of the Cutting Angles of a Biopsy Needle Tip," Journal of Manufacturing Science and Engineering, vol. 134, no. 6, Nov. 2012, Art. no. 061001. DOI: https://doi.org/10.1115/1.4007712
A. Wittek, G. Bourantas, B. F. Zwick, G. Joldes, L. Esteban, and K. Miller, "Mathematical modeling and computer simulation of needle insertion into soft tissue," PLOS ONE, vol. 15, no. 12, Nov. 2020, Art. no. e0242704. DOI: https://doi.org/10.1371/journal.pone.0242704
L. J. Pavlovich, W. L. McClung, J. G. Thacker, R. F. Edlich, and G. T. Rodeheaver, "A synthetic membrane for testing needle penetration," Journal of Applied Biomaterials, vol. 4, no. 2, pp. 157–160, 1993. DOI: https://doi.org/10.1002/jab.770040207
F. A. AlFaraidy and S. Azzam, "Residential Buildings Thermal Performance to Comply With the Energy Conservation Code of Saudi Arabia," Engineering, Technology & Applied Science Research, vol. 9, no. 2, pp. 3949–3954, Apr. 2019. DOI: https://doi.org/10.48084/etasr.2536
A. W. Ali and N. M. Fawzi, "Production of Light Weight Foam Concrete with Sustainable Materials," Engineering, Technology & Applied Science Research, vol. 11, no. 5, pp. 7647–7652, Oct. 2021. DOI: https://doi.org/10.48084/etasr.4377
Z. A. Hussain and N. Aljalawi, "Effect of Sustainable Glass Powder on the Properties of Reactive Powder Concrete with Polypropylene Fibers," Engineering, Technology & Applied Science Research, vol. 12, no. 2, pp. 8388–8392, Apr. 2022. DOI: https://doi.org/10.48084/etasr.4750
Y. Mobarak and A. Thabet, "Predictable Models and Experimental Measurements for Electric Properties of Polypropylene Nanocomposite Films," International Journal of Electrical and Computer Engineering, vol. 6, no. 1, pp. 120–129, Feb. 2016. DOI: https://doi.org/10.11591/ijece.v6i1.9108
H. O. Gulsoy and M. Tasdemır, "Physical and Mechanical Properties of Polypropylene Reinforced with Fe Particles," International Journal of Polymeric Materials and Polymeric Biomaterials, vol. 55, no. 8, pp. 619–626, Aug. 2006. DOI: https://doi.org/10.1080/00914030500257664
H. H. Kim, M. Mazumder, S.-J. Lee, and M.-S. Lee, "Laboratory Evaluation of Sustainable PMA Binder Containing Styrene-Isoprene-Styrene (SIS) and Thermoplastic Polyurethane," Sustainability, vol. 12, no. 23, Jan. 2020, Art. no. 10057. DOI: https://doi.org/10.3390/su122310057
E. K. Roh, "Mechanical properties and preferences of natural and artificial leathers, and their classification with a focus on leather for bags," Journal of Engineered Fibers and Fabrics, vol. 15, no. 1, pp. 1–10, Jan. 2020. DOI: https://doi.org/10.1177/1558925020968825
K. Gerlach, H. J. Pitowski, and K. Schneider, "Synthetic leather product and method of production," US3974320A, Aug. 10, 1976.
I. N. Akpınar and T. Y. Kuzan, "Perkutan Biyopsi: Igne Secimi ve Goruntuleme Kilavuzlari," Turk Radyoloji Seminerleri, vol. 3, pp. 159–168, 2015. DOI: https://doi.org/10.5152/trs.2015.215
J. W. Charboneau, C. C. Reading, and T. J. Welch, "CT and sonographically guided needle biopsy: current techniques and new innovations," AJR American journal of roentgenology, vol. 154, no. 1, pp. 1–10, Jan. 1990. DOI: https://doi.org/10.2214/ajr.154.1.2104689
K. D. Hopper, C. S. Abendroth, K. W. Sturtz, Y. L. Matthews, L. A. Stevens, and S. J. Shirk, "Automated biopsy devices: a blinded evaluation.," Radiology, vol. 187, no. 3, pp. 653–660, Jun. 1993. DOI: https://doi.org/10.1148/radiology.187.3.8497611
C. Reading, J. Charboneau, E. James, and M. Hurt, "Sonographically guided percutaneous biopsy of small (3 cm or less) masses," American Journal of Roentgenology, vol. 151, no. 1, pp. 189–192, Jul. 1988. DOI: https://doi.org/10.2214/ajr.151.1.189
A. C. Goncalves, S. Cavassana, F. R. Chavarette, R. Outa, S. J. Casarin, and A. V. Corazza, "Variation of the Penetration Effort in an Artificial Tissue by Hypodermic Needles," Journal of Healthcare Engineering, vol. 2020, Sep. 2020, Art. no. 8822686. DOI: https://doi.org/10.1155/2020/8822686
S. Aoyagi, H. Izumi, and M. Fukuda, "Biodegradable polymer needle with various tip angles and consideration on insertion mechanism of mosquito’s proboscis," Sensors and Actuators A: Physical, vol. 143, no. 1, pp. 20–28, May 2008. DOI: https://doi.org/10.1016/j.sna.2007.06.007
Downloads
How to Cite
License
Copyright (c) 2022 Ersin Kayahan, Sayit Ozbey, Ugur Kosa, Mehmet Alp Ilgaz, Selma Corovic
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain the copyright and grant the journal the right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) after its publication in ETASR with an acknowledgement of its initial publication in this journal.
