Skip to main content

The Impact of Fatigue Testing and Surface Processing on Nickel Release in Nitinol Stents

Shape Memory and Superelasticity volume 4, pages 462–471 (2018)Cite this article

Abstract

Immersion testing of medical implants is typically performed under non-loaded conditions to assess susceptibility of metal ion release from a device. However, many implants are subjected to repetitive forces in vivo, which may increase ion release into surrounding tissues. Therefore, the objective of this study was to determine whether fatigue loading of stents with different surface finishes accelerates nickel release. Nitinol stents with an electropolished (EP) oxide or blue oxide (BO) were assigned to the following groups: (1) static immersion without loading, (2) static fluid pressure and bend, (3) dynamic pressure on a static bend, and (4) dynamic bending with static pressure. Immersion fluid was collected periodically and analyzed for nickel concentration using ICP-MS. Results indicated nickel release under dynamic bending was greater by up to 280× for EP and 190× for BO finishes compared to all other groups (p < 0.02). Although not significant (p > 0.27), nickel release under dynamic pressure conditions was up to 50× higher compared to static groups. In addition, BO stents released up to 6× greater levels of nickel compared to EP stents for static immersion, dynamic pressure, and dynamic bending groups (p < 0.05). These findings highlight the impact of fatigue loading on uniform corrosion for different nitinol stent surfaces.

This is a preview of subscription content, access via your institution.

Access options

Buy single article

Instant access to the full article PDF.

USD 39.95

Price includes VAT (USA)
Tax calculation will be finalised during checkout.

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6
Fig. 7
Fig. 8
Fig. 9
Fig. 10
Fig. 11

References

  1. Decker JF, Trepanier C, Vien L, Pelton AR (2011) The Effect of material removal on the corrosion resistance and biocompatibility of nitinol laser-cut and wire-form products. J Mater Eng Perform 20(4–5):802–806

    Article  Google Scholar 

  2. Trepanier C, Tabrizian M, Yahia L, Bilodeau L, Piron D (1996) Improvement of the corrosion resistance of NiTi stents by surface treatments. MRS Proceedings, Cambridge Univ Press, Cambridge, p. 363

  3. Trepanier C, Tabrizian M, Yahia LH, Bilodeau L, Piron DL (1998) Effect of modification of oxide layer on NiTi stent corrosion resistance. J Biomed Mater Res 43(4):433–440

    Article  Google Scholar 

  4. Zhu L, Trepanier C, Pelton A, Fino JM (2003) Oxidation of nitinol and its effect on corrosion resistance, ASM Materials and Processes for Medical Devices Conference, ASM Publication, Materials Park

  5. Saylor DM, Craven BA, Chandrasekar V, Simon DD, Brown RP, Sussman EM (2018) Predicting patient exposure to nickel released from cardiovascular devices using multi-scale modeling. Acta Biomater 70:304–314

    Article  Google Scholar 

  6. Santin M, Mikhalovska L, Lloyd AW, Mikhalovsky S, Sigfrid L, Denyer SP, Field SN, Teer D (2004) In vitro host response assessment of biomaterials for cardiovascular stent manufacture. J Mater Sci 15(4):473–477

    Google Scholar 

  7. Wataha JC, O’Dell NL, Singh BB, Ghazi M, Whitford GM, Lockwood PE (2001) Relating nickel-induced tissue inflammation to nickel release in vivo. J Biomed Mater Res 58(5):537–544

    Article  Google Scholar 

  8. Lai DW, Saver JL, Araujo JA, Reidl M, Tobis J (2005) Pericarditis associated with nickel hypersensitivity to the Amplatzer occluder device: a case report. Catheter Cardiovasc Interv 66(3):424–426

    Article  Google Scholar 

  9. Rigatelli G, Cardaioli P, Giordan M, Aggio S, Chinaglia M, Braggion G, Roncon L (2007) Nickel allergy in interatrial shunt device-based closure patients. Congenit Heart Dis 2(6):416–420

    Article  Google Scholar 

  10. Gimenez-Arnau A, Riambau V, Serra-Baldrich E, Camarasa JG (2000) Metal-induced generalized pruriginous dermatitis and endovascular surgery. Contact Dermat 43(1):35–40

    Article  Google Scholar 

  11. Slavin L, Tobis JM, Rangarajan K, Dao C, Krivokapich J, Liebeskind DS (2007) Five-year experience with percutaneous closure of patent foramen ovale. Am J Cardiol 99(9):1316–1320

    Article  Google Scholar 

  12. Fukahara K, Minami K, Reiss N, Fassbender D, Koerfer R (2003) Systemic allergic reaction to the percutaneous patent foramen ovale occluder. J Thorac Cardiovasc Surg 125(1):213–214

    Article  Google Scholar 

  13. Kim KH, Park JC, Yoon NS, Moon JY, Hong YJ, Park HW, Kim JH, Ahn Y, Jeong MH, Cho JG (2008) A case of allergic contact dermatitis following transcatheter closure of patent ductus arteriosus using Amplatzer ductal occluder. Int J Cardiol 127(2):e98–e99

    Article  Google Scholar 

  14. Khodaverdian RA, Jones KW (2009) Metal allergy to Amplatzer occluder device presented as severe bronchospasm. Ann Thorac Surg 88(6):2021–2022

    Article  Google Scholar 

  15. Jetty P, Jayaram S, Veinot J, Pratt M (2013) Superficial femoral artery nitinol stent in a patient with nickel allergy. J Vasc Surg 58(5):1388–1390

    Article  Google Scholar 

  16. Köster R, Vieluf D, Kiehn M, Sommerauer M, Kähler J, Baldus S, Meinertz T, Hamm CW (2000) Nickel and molybdenum contact allergies in patients with coronary in-stent restenosis. Lancet 356(9245):1895–1897

    Article  Google Scholar 

  17. Hillen U, Haude M, Erbel R, Goos M (2002) Evaluation of metal allergies in patients with coronary stents. Contact Dermat 47(6):353–356

    Article  Google Scholar 

  18. Iijima R, Ikari Y, Amiya E, Tanimoto S, Nakazawa G, Kyono H, Hatori M, Miyazawa A, Nakayama T, Aoki J (2005) The impact of metallic allergy on stent implantation: metal allergy and recurrence of in-stent restenosis. Int J Cardiol 104(3):319–325

    Article  Google Scholar 

  19. Romero-Brufau S, Best PJ, Holmes DR, Mathew V, Davis MD, Sandhu GS, Lennon RJ, Rihal CS, Gulati R (2012) Outcomes after coronary stent implantation in patients with metal allergy. Circulation 5(2):220–226

    Google Scholar 

  20. Rabkin DG, Whitehead KJ, Michaels AD, Powell DL, Karwande S (2009) Unusual presentation of nickel allergy requiring explantation of an Amplatzer atrial septal occluder device. Clin Cardiol 32(8):E55–E57

    Article  Google Scholar 

  21. McLucas E, Rochev Y, Carroll WM, Smith TJ (2008) Analysis of the effects of surface treatments on nickel release from nitinol wires and their impact on candidate gene expression in endothelial cells. J Mater Sci Mater Med 19(3):975–980

    Article  Google Scholar 

  22. Wever DJ, Veldhuizen AG, de Vries J, Busscher HJ, Uges DRA, van Horn JR (1998) Electrochemical and surface characterization of a nickel-titanium alloy. Biomaterials 19(7–9):761–769

    Article  Google Scholar 

  23. Wu S, Chu PK, Liu X, Chung C, Ho J, Chu C, Tjong S, Yeung K, Lu W, Cheung K (2006) Surface characteristics, mechanical properties, and cytocompatibility of oxygen plasma-implanted porous nickel titanium shape memory alloy. J Biomed Mater Res, Part A 79(1):139–146

    Article  Google Scholar 

  24. Pérez LM, Gracia-Villa L, Puértolas JA, Arruebo M, Irusta S, Santamaria J (2009) Effect of Nitinol surface treatments on its physico-chemical properties. J Biomed Mater Res, Part B 91(1):337–347

    Article  Google Scholar 

  25. Cui Z, Man H, Yang X (2005) The corrosion and nickel release behavior of laser surface-melted NiTi shape memory alloy in Hanks’ solution. Surf Coat Technol 192(2):347–353

    Article  Google Scholar 

  26. Thierry B, Tabrizian M, Trepanier C, Savadogo O, Yahia LH (2000) Effect of surface treatment and sterilization processes on the corrosion behavior of NiTi shape memory alloy. J Biomed Mater Res 51(4):685–693

    Article  Google Scholar 

  27. Sullivan SL, Dreher M, Zheng J, Chen L, Madamba D, Miyashiro K, Trépanier C, Nagaraja S (2015) Effects of oxide layer composition and radial compression on nickel release in nitinol stents. Shape Mem Superelasticity 1(3):319–327

    Article  Google Scholar 

  28. Clarke B, Carroll W, Rochev Y, Hynes M, Bradley D, Plumley D (2006) Influence of nitinol wire surface treatment on oxide thickness and composition and its subsequent effect on corrosion resistance and nickel ion release. J Biomed Mater Res, Part A 79(1):61–70

    Article  Google Scholar 

Download references

Acknowledgements

This study was made possible through research collaborative agreements between FDA and Medical Device Testing (now Element Materials Technology Corporation) and G. Rau Inc. The authors would like to thank FDA researchers Shiril Sivan and Stacey Sullivan for technical assistance and David Saylor for manuscript review. The authors would like to acknowledge the FDA White Oak Nanotechnology Core Facility for instrument use, scientific and technical assistance. The findings and conclusions in this paper have not been formally disseminated by the Food and Drug Administration, are the views of the authors, and should not be construed to represent any agency determination or policy. The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by Department of Health and Human Services.

Author information

Authors and Affiliations

  1. G. Rau Inc., 3350 Scott Blvd. Bldg. 37B, Santa Clara, CA, 95054, USA

    Srinidhi Nagaraja & Alan R. Pelton

  2. U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Silver Spring, MD, USA

    Srinidhi Nagaraja & Vaishnavi Chandrasekar

  3. Element Materials Technology Corporation, Medical Device Testing Services, Minnetonka, MN, USA

    David Ormonde, Hailey Hickey, Kristen Lipschultz, Calvin Chao & Kent Vilendrer

Authors
  1. Srinidhi Nagaraja
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Vaishnavi Chandrasekar
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. David Ormonde
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Hailey Hickey
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Kristen Lipschultz
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Calvin Chao
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Kent Vilendrer
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Alan R. Pelton
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Srinidhi Nagaraja.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Nagaraja, S., Chandrasekar, V., Ormonde, D. et al. The Impact of Fatigue Testing and Surface Processing on Nickel Release in Nitinol Stents. Shap. Mem. Superelasticity 4, 462–471 (2018). https://doi.org/10.1007/s40830-018-00196-0

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40830-018-00196-0

Keywords

  • Cardiovascular stents
  • Biocompatibility
  • Nitinol
  • Corrosion
  • Nickel release
  • Fatigue
  • Surface processing