A Multi-Waveform Visceral Neuromodulation Device with a Translational Visceral Electrode Foundry

Asthma, hypertension and diabetes impact one half of the world's civilian and military population resulting in premature death for many people. The sympathetic and parasympathetic visceral nerves which enervate the dysfunctional end organ may represent a neural stimulation target to reduce the impact of disease. However, the development of visceral nerve therapies has been inhibited for many years due to a lack of chronic, wireless, tools for exploring stimulation dosing in pre-clinical and early feasibility human models. Numerous technical challenges associated with bi-phasic pulse generator electronics and ultra-soft materials fabrication must be solved to deliver precision dosing parameters to 100 to 3000 micron diameter visceral nerves. We will develop a Multi-scale, Multi-waveform, and 16-channel bi-phasic pulse generator with the most expansive range of pulse parameters to date, spanning from animals to humans. We will create a Translational, Multi-scale Visceral Neural Electrode Foundry which will design and commercialize over 10 chronic visceral nerve electrodes from 100 µm - 3000 µm diameter with a 75% reduced volume. Finally, we propose a concurrent Option period to implement a Quality Management System and to perform ISO-10993 biocompatibility studies to expedite Clinical translation of visceral electrodes created at the foundry.