Ion Leaching from Implantable Medical Devices

Author:

Eiselstein Lawrence E.1,Caligiuri Robert D.1

Affiliation:

1. Exponent

Abstract

Implantable medical devices must be able to withstand the corrosive environment of the human body for 10 or more years without adverse consequences. Most reported research and development has been on developing materials and devices that are biocompatible and resistant to corrosion-fatigue, pitting, and crevice corrosion. However, little has been directly reported regarding implantable materials with respect to the rate at which they generate soluble ions in-vivo. Most of the biocompatibility studies have been done by examining animal implants and cell cultures rather than examining the rate at which these materials leach ions into the body. This paper will discuss what is currently known about the rate at which common implant materials (such as stainless steels, cobalt-chromium alloys, and nitinol) elute ions under in vitro conditions, what the limitations are of such data, and how this data can be used in medical device development.

Publisher

Trans Tech Publications, Ltd.

Subject

Mechanical Engineering,Mechanics of Materials,Condensed Matter Physics,General Materials Science

Reference31 articles.

1. Ratner, B.D., Correlation of Material Surface Properties with Biological Responsed, in Biomaterials Science: An Introduction to Materials in Medicine, B.D. Ratner, et al., Editors. 1996, Academic Press: San Diego, CA.

2. ASTM F 746-87, Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials, in Annual Book of ASTM Standards. 1987, American Society for Testing and Materials: Philadelphia. pp.221-226.

3. ASTM F 2129-08, Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices, in Annual Book of ASTM Standards. 2008, American Society for Testing and Materials: Philadelphia, PA. pp.1684-1690.

4. Eiselstein, L.E., et al., Acceptance criterion for the corrosion resistance of medical devices: A statistical study of the pitting susceptibility of Nitinol, accounting for the in-vivo environment, in SMST 2008 - International Conference on Shape Memory and Superelastic Technologies. 2008, ASM: Stresa, Italy.

5. Eiselstein, L.E., D.M. Proctor, and T.C. Flowers, Trivalent and Hexavalent Chromium Issues in Medical Implants. Materials Science Forum, 2007. Vols. 539543: p. pp.698-703.

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