Objective: The study describes the development and testing of a dry surface stimulation flexible electrode (herein referred to as Flexatrode), a low-cost, flexible, and scalable elastomeric nanocomposite using carbon black (CB) and polydimethylsiloxane (PDMS).
Methods: Flexatrodes composed of CB and PDMS were developed and tested for mechanical and functional stability up to 7 days. Uniform CB distribution was achieved by optimizing the dispersion process using toluene and methyl-terminated PDMS. Electromechanical testing in the through thickness directions over a long-term duration demonstrated stability of Flexatrode. Thermal stability of Flexatrode for up to a week was tested and validated, thus mitigating concerns of heat generation and deleterious skin reactions such as vasodilation or erythema.
Results: 25 wt.% CB was determined to be the optimal concentration. Electrical and thermal stability were demonstrated in the through thickness direction.
Conclusion: Flexatrode provides stable electrical properties combined with high flexibility and elasticity. Electrotherapy treated chronic wounds were 81.9% smaller than baseline at day 10. Wounds that received an inactive device (device without any electrical stimulation) were 58.1% smaller than baseline and wounds that received standard of care treatment were 62.2% smaller than baseline.
Significance: The increasing need for wearable bioelectronics requiring long-term monitoring/treatment has highlighted the limitations of sustained use of gel-based electrodes. These can include skin irritation, bacterial overgrowth at the electrode site, gel dehydration over time, and signal degradation due to eccrine sweat formation. Flexatrode provides stable performance in a nanocomposite with scalable fabrication, thus providing a promising platform technology for wearable bioelectronics.