A significant potential for plastic hypodermic needles exists as an alternative to current steel needles. This paper presents the design and testing of one type of plastic hypodermic needle. The buckling and penetration characteristics of the needles were modeled and analyzed analytically and by finite element analyses. Experimental penetration tests using plastic and steel control hypodermic needles with skin mimics, specifically polyurethane film and pig skin, were performed to determine penetration and friction forces. Lubricated plastic needles achieved successful penetrations in 25–75% of the tests in both polyurethane film and pig skin with penetration forces ranging from 7 N to 10 N. Penetration tests into butyl rubber stoppers also were conducted with lubricated plastic needles penetrating in 75% of the tests with an average penetration force of 8.3 N. Various lubricants, including silicone oil and a medical grade silicone dispersion, were also studied. In addition, the needles underwent successful perpendicular bending tests and cannula stiffness tests. Finally, fluid flow tests determined fluid flow rates through the needles. Experimental results were compared with each other and to finite element analyses and are discussed.
Issue Section:
Research Papers
Keywords:
bending,
biomedical equipment,
biomedical materials,
buckling,
finite element analysis,
lubricating oils,
mechanical testing,
needles,
plastics,
polymer films,
silicones,
plastic hypodermic needle,
penetration force,
buckling force,
steel hypodermic needle,
injection,
flow rate,
lubricants
1.
Miller
, M. A.
, and Pisani
, E.
, 1999, “The Cost of Unsafe Injections
,” Bull. World Health Organ
0042-9686, 77
(10
), pp. 808
–811
.2.
Tamplin
, S. A.
, Davidson
, D.
, Powis
, B.
, and O'Leary
, Z.
, 2005, “Issues and Options for the Safe Destruction and Disposal of Used Injection Materials
,” Waste Manage.
0956-053X, 25
, pp. 655
–665
.3.
Mujeeb
, S. A.
, Adil
, M. M.
, Altaf
, A.
, Hutin
, Y.
, and Luby
, S.
, 2003, “Recycling of Injection Equipment in Pakistan
,” Infect. Control Hosp. Epidemiol.
0899-823X, 24
(2
), pp. 145
–146
.4.
Kou
, U. K.
, 2001, “The Costs of Waste Management of Sharps From Immunization Activities: A Case Study From South Africa
,” Department of Vaccines and Biologicals, Unpublished WHO Report.5.
Haltmeier
, M.
, 2002, “Putting Injection Waste Out of Harm’s Way
,” GAVI Immunization Focus, pp. 6
–8
.6.
Ekwueme
, D. U.
, Weniger
, B. G.
, and Chen
, R. T.
, 2002, “Model-Based Estimates of Risks of Disease Transmission and Economic Costs of Seven Injection Devices in Sub-Saharan Africa
,” Bull. World Health Organ
0042-9686, 80
(11
), pp. 859
–870
.7.
Hauri
, A. M.
, Armstrong
, G. L.
, and Hutin
, Y. J. F.
, 2004, “The Global Burden of Disease Attributable to Contaminated Injections Given in Health Care Settings
,” Int. J. STD AIDS
0956-4624, 15
, pp. 7
–16
.8.
Dziekan
, G.
, Chisholm
, D.
, Johns
, B.
, Rovira
, J.
, and Hutin
, Y. J. F.
, 2003, “The Cost-Effectiveness of Policies for the Safe and Appropriate Use of Injection in Healthcare Settings
,” Bull. World Health Organ
0042-9686, 81
(4
), pp. 277
–285
.9.
Simonsen
, L.
, Kane
, A.
, Lloyd
, J.
, Zaffran
, M.
, and Kane
, M.
, 1999, “Unsafe Injections in the Developing World and Transmission of Bloodborne Pathogens: A Review
,” Bull. World Health Organ
0042-9686, 77
(10
), pp. 789
–800
.10.
Kane
, A.
, Lloyd
, J.
, Zaffran
, M.
, Simonsen
, L.
, and Kane
, M.
, 1999, “Transmission of Hepatitis B, Hepatitis C and Human Immunodeficiency Viruses Through Unsafe Injections in the Developing World: Modelbased Regional Estimates
,” Bull. World Health Organ
0042-9686, 77
(10
), pp. 801
–807
.11.
Lloyd
, J. S.
, and Milstien
, J. B.
, 1999, “Auto-Disable Syringes for Immunization: Issues in Technology Transfer
,” Bull. World Health Organ
0042-9686, 77
(12
), pp. 1001
–1007
.12.
Nelson
, C. M.
, Sutanto
, A.
, and Suradana
, I. G.
, 1999, “Use of Soloshot Autodestruct Syringes Compared With Disposable Syringes, in a National Immunization Campaign in Indonesia
,” Bull. World Health Organ
0042-9686, 77
(1
), pp. 29
–33
.13.
Hutin
, Y. J. F.
, and Chen
, R. T.
, 1999, “Injection Safety: A Global Challenge
,” Bull. World Health Organ
0042-9686, 77
(10
), pp. 787
–788
.14.
Battersby
, A.
, Feilden
, R.
, and Nelson
, C.
, 1999, “Sterilizable Syringes: Excessive Risk or Cost-Effective Option?
,” Bull. World Health Organ
0042-9686, 77
(10
), pp. 812
–819
.15.
Steinglass
, R.
, Boyd
, D.
, Grabowsky
, M.
, Laghari
, A. G.
, Khan
, M. A.
, Qavi
, A.
, and Evans
, P.
, 1995, “Safety, Effectiveness and Ease of Use of a Non-Reusable Syringe in a Developing Country Immunization Programme
,” Bull. World Health Organ
0042-9686, 73
(1
), pp. 57
–63
.16.
Hutin
, Y. J. F.
, Hauri
, A. M.
, and Armstrong
, G. L.
, 2003, “Use of Injections in Health Care Settings Worldwide Literature Review and Regional Estimates
,” BMJ
0959-8138, 327
, p. 1075
.17.
Fortner
, T.
, Wynn
, H.
, Heffner
, H.
, and Colton
, J. S.
, 2009, “Oven Melting Encapsulization of Hypodermic Needles by Syringes
,” J. Med. Eng. Technol.
0309-1902, 33
(8
), pp. 616
–621
.18.
Kim
, H.
, and Colton
, J. S.
, 2004, “Fabrication and Analysis of Plastic Hypodermic Needles
,” SPE-ANTEC Technical Papers, 3727.19.
Kim
, H.
, and Colton
, J. S.
, 2005, “Fabrication and Analysis of Plastic Hypodermic Needles
,” J. Med. Eng. Technol.
0309-1902, 29
(4
), pp. 181
–186
.20.
Love
, J.
, and Green
, A.
, 2003, “A Novel Polymer Needle for Insulin Delivery
,” Med. Device Technol.
, 14
(8
), pp. 22
–23
.21.
Busillo
, E.
, 2008, “Characterization of Plastic Hypodermic Needles
,” M.S. thesis, Georgia Institute of Technology.22.
2001,
Ticona GmbH
, Vectra Liquid Crystal Polymer (LCP), VC-7.23.
Stevens
, J. F.
, Smith
, T. G.
, and Bartlett
, J. H.
, 1997, “Method of Manufacturing Needles
,” US Patent No. 5,620,639.24.
Shergold
, O. A.
, and Fleck
, N. A.
, 2004, “Mechanisms of Deep Penetration of Soft Solids, With Application to the Injection and Wounding of Skin
,” Proc. R. Soc. London, Ser. A
0950-1207, 460
, pp. 3042 and 3048
–3050
.25.
Shergold
, O. A.
, and Fleck
, N. A.
, 2005, “Experimental Investigation Into the Deep Penetration of Soft Solids by Sharp and Blunt Punches, With Application to the Piercing of Skin
,” ASME J. Biomech. Eng.
0148-0731, 127
(5
), pp. 838
–848
.26.
Abolhassani
, N.
, Patela
, R.
, and Moallema
, M.
, 2007, “Needle Insertion Into Soft Tissue: A Survey
,” Med. Eng. Phys.
1350-4533, 29
(4
), pp. 413
–431
.27.
O’Leary
, M. D.
, Simone
, C.
, Washio
, T.
, Yoshinaka
, K.
, and Okamura
, A. M.
, 2003, “Robotic Needle Insertion: Effects of Friction and Needle Geometry
,” IEEE International Conference on Robotics and Automation
, pp. 1774
–1780
.28.
Podder
, T. K.
, Sherman
, J.
, Fuller
, D.
, Messing
, E. M.
, Rubens
, D. J.
, Strang
, J. G.
, Brasacchio
, R. A.
, and Yu
, Y.
, 2006, “In Vivo Motion and Force Measurement of Surgical Needle Intervention During Prostate Brachytherapy
,” Med. Phys.
0094-2405, 33
(8
), pp. 2915
–2922
.29.
Fung
, Y. C.
, 1993, Biomechanics: Mechanical Properties of Living Tissues
, Springer-Verlag
, New York
.30.
Barbé
, L.
, Bayle
, B.
, de Mathelin
, M.
, and Gangi
, A.
, 2007, “Needle Insertions Modeling: Identifiability and Limitations
,” Biomed. Signal Process. Control
, 2
(3
), pp. 191
–198
.31.
2007, “
McMaster–Carr Specifications for Polyurethane Film
,” No. 1446T31, Catalog 10/09/07, p. 3460
.32.
U.S. Centers for Disease Control and Prevention
, 2006, “General Recommendations on Immunizations: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP)
,” MMWR Morb Mortal Wkly Rep.
0149-2195, 55
, pp. 1
–48
.33.
1993, ISO 7864:1993(E) Sterile Hypodermic Needles for Single Use.
34.
1991, ISO 9626: 1991(E) Stainless Steel Tubing for Manufacture of Medical Devices.
35.
2002, DIN 13097 (09/2002) Medical Needles—Point Designs and Testing.
36.
2002,
Dow Corning
, MDX4-4159 Fluid 50% Medical Grade Dispersion, Product Information, Healthcare, 51-0599F-01.37.
2002,
Dow Corning
, Dow Corning MDX4-4159 50% Medical Grade Dispersion, Frequently Asked Questions, 52-1039-01.38.
1993, ISO 7886-1:1993/Correction 1:1995 Sterile Hypodermic Syringes for Single Use—Part 1: Syringes for Manual Use.
39.
1998,WHO/EPI/LHIS/97.11 Equipment Performance Specifications And Test Procedures—E8: Injection Devices, World Health Organization, Geneva, 1997.
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