Device and Procedure for Closed-Loop Endovascular Vagus Nerve Stimulation and Evoked Response Sensing

BACKGROUND AND OBJECTIVES: Vagus nerve stimulation (VNS) is a United States Food and Drug Administration–approved treatment for refractory epilepsy, stroke rehabilitation, chronic or recurrent depression as adjunctive therapy, and rheumatoid arthritis. It is also being explored as a potential treatment modality for heart failure and relapsing-remitting multiple sclerosis among other disease states. The current mode of stimulation delivery employed widely is the use of nerve cuffs mounted directly on the nerve via an invasive cervical cutdown procedure. Furthermore, the feedback from the nerve upon stimulation delivery is not monitored. It has also been reported that the internal fascicular organization along the vagus nerve is highly variable and therefore different groups of fascicles can be selectively activated based on electrode position. However, it is not possible to change the position of the nerve cuff without additional surgery if placed in a suboptimal location. METHODS: In this work, we propose the development of a device for closed-loop endovascular VNS that helps mitigate the challenges highlighted earlier and demonstrate this in a preclinical model on 4 subjects. In this minimally invasive procedure, a resheathable stent form factor is deployed within the jugular vein, providing an opportunity for intraprocedural trialing. RESULTS: We demonstrate accurate detection of nerve activation via endovascular evoked compound action potential along with an indication of the specific fibers being activated. Furthermore, this procedure also offers an opportunity to reduce side effects including muscle activation that is seen in current VNS procedures by tuning the applied stimulation. CONCLUSION: This closed-loop endovascular VNS stimulation platform technology opens up a new paradigm for ongoing research in peripheral nerve stimulation, affecting several disease states.