The role of materials biocompatibility for functional electrical stimulation applications.

The biocompatibility of all metallic, polymeric, or ceramic materials used for functional electrical stimulation is governed by the inevitable inflammatory tissue response, but possibly also by immunological reactions to the bulk material or released constituents. Besides chemical, physical, and corrosion properties of the conductive electrode materials, increased surface area and roughness of the electrode can influence tissue contact and signal delivery, and can also affect electrode-tissue impedance due to increased connective tissue encapsulation. The polymeric materials used for electrode insulation and those for leads and stimulator packaging seem more or less compatible in an aggressive biological environment. For the long-term performance of electrodes and leads, the relative motion in the various implant bed situations also has to be considered.