journal article·2016-05

Fatigue and fracture of wires and cables for biomedical applications

J. L. Gbur, J. J. Lewandowski

International Materials Reviews· Volume 61· Issue 4
Publisher page

Abstract

Fine wires and cables play a critical role in the design of medical devices and subsequent treatment of a large array of medical diagnoses. Devices such as guide wires, catheters, pacemakers, stents, staples, functional electrical stimulation systems, eyeglass frames and orthodontic braces can be comprised of wires with diameters ranging from 10s to 100s of micrometres. Reliability is paramount as part of either internal or external treatment modalities. While the incidence of verified fractures in many of these devices is quite low, the criticality of these components requires a strong understanding of the factors controlling the fracture and fatigue behaviour. 1 , 2 Additionally, optimisation of the performance and reliability of these devices necessitates characterisation of the fatigue and fracture properties of its constituent wires. A review of cable architecture and stress states experienced during testing is followed by an overview of the effects of changes in material composition, microstructure, processing and test conditions on fracture and fatigue behaviour of wire and cable systems used in biomedical applications. The review concludes with recommendations for future work.
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Research context

OpenAlex topics: Mechanical stress and fatigue analysis · Mechanical Failure Analysis and Simulation · Hydrogen embrittlement and corrosion behaviors in metals

SciVX discovery tags are terminology-based. OpenAlex topics are source-provided classifications.

Affiliations

Department of Materials Science and Engineering, Case Western Reserve University

References (100+)

Show source-provided references
1. 10.1016/S1350-4533(96)00022-710.1016/S1350-4533(96)00022-7 ↗
2. 10.1002/(SICI)1097-4636(199821)43:1<21::AID-JBM3>3.0.CO;2-O10.1002/(SICI)1097-4636(199821)43:1<21::AID-JBM3>3.0.CO;2-O ↗
3. 3M Unitek: ‘Archwire systems’ 2014 [viewed 2014 August 25]; Available from: http://solutions.3m.com/wps/portal/3M/en_WW/unitek-ww/home/products/archwire/.
4. Benini B.: ‘Tension and flex fatigue behavior of small diameter wires for biomedical applications’ M.S. Case Western Reserve University 2010.
5. Fort Wayne Metals: ‘Wire products’ 2013 [viewed 2013 July 18]; Available from: www.fwmetals.com.
6. 10.1590/S2176-9451201300040000710.1590/S2176-94512013000400007 ↗
7. Iguchi Y. Narushima T. Suzuki K. Yoshida S. Watanabe M. Kinami T. Ouchi C.: ‘Fatigue property of stainless steel FES electrode in Hank's solution’ 7th Annual Conference of the International Functional Electrical Stimulation Society Ljubljana Slovenia 2002 217–219.
8. Iguchi Y. Ouchi C. Narushima T. Watanabe M. Kinami T. Nishikawa T. Hoshimiya N. Handa Y.: ‘Development of implanted bio-materials and application to FES electrodes as the interface between stimulator and nerve’ 5th Annual Conference of the International Functional Electrical Stimulation Society Center for Sensory-Motor Interaction (SMI) Aalborg University Denmark 2000 253–256.
9. Iijima T.: ‘Eyeglass frame and method of making same’ Patent No. 5 452 028 USA 1–8 1995.
10. 10.1016/j.msea.2008.03.01610.1016/j.msea.2008.03.016 ↗
11. 10.1016/j.msea.2007.11.01610.1016/j.msea.2007.11.016 ↗
12. 10.1016/j.biomaterials.2005.10.01210.1016/j.biomaterials.2005.10.012 ↗
13. 10.1583/10-3069.110.1583/10-3069.1 ↗
14. 10.2320/matertrans.46.208310.2320/matertrans.46.2083 ↗
15. 10.1016/j.jmbbm.2007.08.00110.1016/j.jmbbm.2007.08.001 ↗
16. 10.1016/S0921-5093(04)00974-810.1016/S0921-5093(04)00974-8 ↗
17. 10.1080/13645700276027334010.1080/136457002760273340 ↗
18. 10.1007/s00330-003-2022-510.1007/s00330-003-2022-5 ↗
19. 10.1682/JRRD.2003.11.045710.1682/JRRD.2003.11.0457 ↗
20. Knutson J. S., Naples G. G., Peckham P. H., Keith M. W.: ‘Electrode fracture rates and occurrences of infection and granuloma associated with percutaneous intramuscular electrodes in upper-limb functional electrical stimulation applications’, J. Rehabil. Res. Dev., 2002, 39, (6), 671–684.
21. 10.1109/86.24242610.1109/86.242426 ↗
22. 10.1016/j.joen.2009.10.03210.1016/j.joen.2009.10.032 ↗
23. Bradley D. Kay L. Lippard H. Stephenson T.: ‘Optimization of melt chemistry and properties of 35cobalt–35nickel–20chromium–10molybdenum alloy medical grade wire’. Paper presented at the Materials and Processes for Medical Devices Conference and Exposition Anaheim CA USA.
24. 10.1016/j.msea.2012.08.11910.1016/j.msea.2012.08.119 ↗
25. Dooley B. A. Lasley C. C. Mitchell M. R. Steele R. R. Tittelbaugh E. M.: ‘Shape memory alloy articles with improved fatigue performance and methods therefor’ Patent No. US 7811393 B2 USA 1–18 2010.
26. 10.1007/s11665-011-9845-z10.1007/s11665-011-9845-z ↗
27. 10.1016/j.ijfatigue.2008.03.01410.1016/j.ijfatigue.2008.03.014 ↗
28. 10.1002/mawe.20080037910.1002/mawe.200800379 ↗
29. Furuichi Y., Tobushi H., Ikawa T., Matsui R.: ‘Fatigue properties of a TiNi shape-memory alloy wire subjected to bending with various strain ratios’, Proc. Inst. Mech. Eng. L: J. Mater. Des. Appl., 2003, 217, (2), 93–99.
30. 10.1002/(SICI)1097-4636(1999)48:3<251::AID-JBM8>3.0.CO;2-710.1002/(SICI)1097-4636(1999)48:3<251::AID-JBM8>3.0.CO;2-7 ↗
31. Kay L. Bradley D.: ‘Optimization of melt chemistry and properties of drawn filled tube (DFT) composite materials of 35cobalt–35nickel–20chromium–10molybdenum alloy (UNS R30035) medical grade wire with silver core’ Materials and Processes for Medical Devices Conference and Exposition St. Paul MN USA ASM International 2004 209–214.
32. 10.1007/s11665-013-0857-810.1007/s11665-013-0857-8 ↗
33. 10.1016/j.jmbbm.2014.02.00810.1016/j.jmbbm.2014.02.008 ↗
34. Lavvafi H.: ‘Effects of laser machining on structure and fatigue of 316LVM biomedical wires’ Ph.D. Case Western Reserve University 2013.
35. Li B. Q. Cho K. Zhang H.: ‘Fatigue behavior and microstructure of Pt-20Ir wire as lead conductor in implantable medical device’ ASME International Mechanical Engineering Congress & Exposition Houtson TX USA 2012 91–95.10.1115/IMECE2012-87976 ↗
36. 10.1007/s11665-012-0387-910.1007/s11665-012-0387-9 ↗
37. Mammano G. S., Dragoni E.: ‘Functional fatigue of NiTi shape memory wires for a range of end loadings and constraints’, Fract. Struct. Integr., 2013, 23, 25–33.
38. Martin P. Fishler M. Hinton T. Mar C. Patel A.: ‘Long fatigue life cardiac harness’ Patent USA 1–13 2009.
39. 10.2320/matertrans.47.75910.2320/matertrans.47.759 ↗
40. Meyer A. A.: ‘Computer aided stress analysis of intramuscular electrode leads constructed as stranded wire helical springs’ M. S. Case Western Reserve University 1985.
41. 10.1016/S0921-5093(99)00344-510.1016/S0921-5093(99)00344-5 ↗
42. Morgan N. B. Painter J. Moffat A. J.: ‘Mean strain effects and microstructural observations during in-vitro fatigue testing of NiTi’ International Conference on Shape Memory and Superelastic Technologies Monterey CA USA ASM International 2003 303–310.
43. 10.1016/j.ijfatigue.2006.09.02110.1016/j.ijfatigue.2006.09.021 ↗
44. 10.1016/j.msec.2006.04.00810.1016/j.msec.2006.04.008 ↗
45. 10.1007/s11665-009-9415-910.1007/s11665-009-9415-9 ↗
46. 10.1007/s11665-014-0939-210.1007/s11665-014-0939-2 ↗
47. Patel M. Plumley D. Bouthot R. Proft J.: ‘The effects of varying active Af temperatures on the fatigue properties of Nitinol wire’ Materials and Processes for Medical Devices Conference and Exposition Boston MA USA 2005.
48. 10.1520/JAI10039010.1520/JAI100390 ↗
49. Patel M. M. Gordon R. F.: ‘An investigation of diverse surface finishes on fatigue properties of superelastic Nitinol wire’ International Conference on Shape Memory and Superelastic Technologies Pacific Grove CA USA 2006.
50. Patel M. M. Plumley D. L. Bouthot R. J. Proft J. L.: ‘The significance of melt practice on fatigue properties of superelastic NiTi fine diameter wire’ International Conference on Shape Memory and Superelastic Technologies Pacific Grove CA USA ASM International 2006 43–52.
51. 10.1016/j.jmbbm.2013.06.00310.1016/j.jmbbm.2013.06.003 ↗
52. Polinsky M. A. Norwich D. W. Wu M. H.: ‘A study of the effects of surface modifications and processing on the fatigue properties of NiTi wire’ International Conference on Shape Memory and Superelastic Technologies Pacific Grove CA USA ASM International 2006 1–17.
53. 10.1002/mawe.20130011810.1002/mawe.201300118 ↗
54. 10.1016/j.actamat.2013.02.05410.1016/j.actamat.2013.02.054 ↗
55. Reinoehl M. Bradley D. Bouthot R. Proft J.: ‘The influence of melt practice on final fatigue properties of superelastic NiTi wires’ International Conference on Shape Memory and Superelastic Technologies Pacific Grove CA USA ASM International 2000 397–403.
56. 10.1007/s11665-014-1062-010.1007/s11665-014-1062-0 ↗
57. 10.1007/s11661-003-0186-x10.1007/s11661-003-0186-x ↗
58. 10.1007/s11663-012-9661-310.1007/s11663-012-9661-3 ↗
59. 10.1007/s11665-009-9363-410.1007/s11665-009-9363-4 ↗
60. 10.1002/jbm.82025050410.1002/jbm.820250504 ↗
61. Sheriff J. Pelton A. R. Pruitt L. A.: ‘Hydrogen effects on Nitinol fatigue’ International Conference on Shape Memory and Superelastic Technology Kurhaus Baden-Baden Baden-Baden Germany ASM International 2004 111–116.
62. Takeda K., Mitsui K., Tobushi H., Levintant-Zayonts N., Kucharski S.: ‘Influence of nitrogen ion implantation on deformation and fatigue properties of TiNi shape memory alloy wire’, Arch. Mech., 2013, 65, (5), 391–405.
63. 10.2320/matertrans.M200907310.2320/matertrans.M2009073 ↗
64. 10.1115/1.280683910.1115/1.2806839 ↗
65. 10.1016/S0167-6636(97)00019-710.1016/S0167-6636(97)00019-7 ↗
66. 10.1115/1.48278510.1115/1.482785 ↗
67. Tobushi H., Okumura K., Nakagawa K., Takata K.: ‘Fatigue properties of TiNi shape memory alloy’, Trans. Mater. Res. Soc. Jpn., 2001, 26, (1), 347–350.
68. 10.1016/j.msea.2003.11.05810.1016/j.msea.2003.11.058 ↗
69. 10.1016/j.joen.2011.09.02810.1016/j.joen.2011.09.028 ↗
70. 10.1002/jbm.b.3011310.1002/jbm.b.30113 ↗
71. Campbell M. P. Johnson B. E.: ‘Test to fracture of cardiac lead coils in unidirectional bending fatigue’. Paper presented at the ASME 2010 Summer Bioengineering Conference Parts A and B Naples FL USA.10.1115/SBC2010-19145 ↗
72. 10.1007/s11665-014-0916-910.1007/s11665-014-0916-9 ↗
73. 10.1016/S0142-1123(02)00014-210.1016/S0142-1123(02)00014-2 ↗
74. 10.1002/jbm.82017040410.1002/jbm.820170404 ↗
75. Adewole K. K.: ‘Effects of defects and reverse bending on tensile properties of tensile armour wires’ Ph.D. Newcastle University 2011.
76. Adewole K. K., Bull S. J.: ‘Simulation of the wire reverse bending test’, J. Civil Eng. Constr. Technol., 2012, 3, (1), 116–126.
77. Bennett J. A. Burnett H. C.: ‘Torsion fatigue testing machine for wire’ Patent No. 2 844 958 USA 1–5 1958.
78. 10.1016/j.ndteint.2006.07.00510.1016/j.ndteint.2006.07.005 ↗
79. 10.1007/BF0242809410.1007/BF02428094 ↗
80. 10.1007/s11709-011-0132-810.1007/s11709-011-0132-8 ↗
81. Vanniamparambil P. A., Khan F., Hazeli K., Cuadra J., Schwartz E., Kontsos A., Bartoli I.: ‘Novel optico-acoustic nondestructive testing for wire break detection in cables’, Struct. Control Health Monit., 2013, 20, (11), 1339–1350.
82. Anderson S.: ‘Review of multiaxis fatigue testing for fatigue/durability of cardiovascular medical devices’, in ‘Fatigue and fracture of medical metallic materials and devices’, (eds. Jerina K., et al.), 1–12; 2010, West Conshohocken,PA, USA, ASTM International.
83. FDA: Non-clinical engineering tests and recommended labeling for intravascular stents and associated delivery systems U. S. D. o. H. a. H. Services Editor. 2010 Center for Devices and Radiological Health: Rockville MD USA 1–55. Available from: http://www.fda.gov/RegulatoryInformation/Guidances/ucm366624.htm
84. 10.1007/978-1-4612-1970-510.1007/978-1-4612-1970-5 ↗
85. 10.1016/0020-7683(91)90060-S10.1016/0020-7683(91)90060-S ↗
86. 10.1016/S0029-8018(96)00052-210.1016/S0029-8018(96)00052-2 ↗
87. 10.1016/0142-1123(89)90001-710.1016/0142-1123(89)90001-7 ↗
88. US Navy: ‘Wire-rope handbook’; 1976; Washington,DC, USA, Naval Sea Systems Command.
89. ASTM: Standard specification for metallic implantable strands and cables in F2180-02 (reapproved 2011). 2011 ASTM International: West Conshohocken PA USA 1–4.
90. Union: Wire rope user's handbook. 2014 WireCo World Group: Kansas City MO USA 1–38.
91. 10.1061/JMCEA3.000250810.1061/JMCEA3.0002508 ↗
92. Chaplin C. R., Rebel G., Ridge I. M. L.: ‘Tension-torsion fatigue effects in wire ropes’, OIPEEC Bull., 1999, 77, 31–36.
93. Durelli A. J., Parks V. J., Hasseem H. M.: ‘Helices under load’, J. Manuf. Sci. Eng., 1975, 97, (3), 853–858.
94. Wahl A. M.: ‘Mechanical springs’, 1944; Cleveland,OH, USA, Penton Publishing Company.
95. BSI: Active implantable medical devices part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) in BS EN 45505-2-2. 2008 BSI 1–108.
96. ISO: Implants for surgery – Active implantable medical devices – Part 1: General requirements for safety marking and for information to be provided by the manufacturer in 14708-1. 2000 ISO: Geneva Switzerland 1–48.
97. ISO: Implants for surgery – Active implantable medical devices – Part 3: Implantable neurostimulators in 14708-3. 2008 ISO: Geneva Switzerland 1–52.
98. ISO: Implants for surgery – Active implantable medical devices – Part 2: Cardiac pacemakers in 14708-2. 2012 ISO: Geneva Switzerland 1–76.
99. ASTM: Standard test method for conducting rotating bending fatigue tests of solid round fine wire in E2948-14. 2014 ASTM International: West Conshohocken PA USA 1–8.
100. ASTM: Standard test method for ductility testing of metallic foil in E796-94 (reapproved 2000). 2000 ASTM International: West Conshohocken PA USA 1–4.