Fabrication and characteristics of an implantable, polymer-based, intrafascicular electrode.

We describe new manufacturing techniques and physical properties of an improved polymer-based longitudinal intrafascicular electrode (polyLIFE). Modifications were made to correct: (1) poor metal film adhesion and fatigue resistance, (2) inconsistent insulation adhesion and control over recording/stimulation zone length, and (3) insufficient tensile strength for clinical use. Metal adhesion was significantly improved by both plasma treatment and fiber rotation (about the long axis) during metal deposition. Fatigue resistance was improved by reduction in sputtering energy (time x power) combined with long axis rotation, resulting in thin metal films that were 250 times more resistant to cyclic bending fatigue. Insulation adhesion was enhanced with the application of an adhesion-promoting silicone (MED2-4013, Nusil), while the recording/stimulation zone length was controlled to 1 +/- 0.2mm (mean +/- S.D.). The polyLIFE was made more robust by the inclusion of three individually metallized fibers, improving its tensile strength by a factor of 4 while producing minimal changes to its overall stiffness. However, the metallized fiber redundancy did not significantly affect fatigue resistance. The manufacturing changes described in this study enable the construction of more mechanically robust polyLIFEs, which should provide greater success when chronically implanted in peripheral nerves.