Chronic Tibial Nerve Stimulation Augmented by Injection of an Easy-to-Remove Helical Wire Structure Electrode in Swine.

Authors

Kevin Yang, Noa Nuzov, Stephan Nieuwoudt, Derrick X Liu, Anna Lauricella, David Valencia, Emily Szabo, Nishant Verma, Ashley Dalrymple, Douglas Weber, Fayez Syed, Ansh Bhatia, Pranav Balabhadra, Danny Lam, Hesham Elsharkawy, Amol Soin, Alaa Abd-Elsayed, Manfred Franke, Kip Ludwig, Kenneth J Gustafson, Andrew J Shoffstall

Published in

Neuromodulation : journal of the International Neuromodulation Society. Sep 24, 2026. Epub Sep 24, 2026.

Abstract

Our objective was to assess the delivery and function of a helical microwire structure electrode (HMSE) via stimulation of the tibial nerve in a porcine model. The HMSE consists of a helical microwire lead connected to a small subcutaneous "collector," with no wires traversing the skin. This design uses only two passive implanted components-a helical microwire lead and a subcutaneous collector-potentially reducing surgical complexity, long-term failure modes, and overall cost compared with traditional implanted stimulators.
HMSEs were chronically implanted in swine under isoflurane anesthesia, using ultrasound guidance to place the electrode adjacent to the tibial nerve analogous to clinical posterior tibial nerve stimulation. Electrical stimulation was delivered noninvasively by placing a standard surface transcutaneous electrical nerve stimulation (TENS) electrode over the collector site, allowing current to pass through skin and subcutaneous tissue to the implanted lead (externally-driven stimulation). Visible motor response thresholds were measured in response to varying current- and voltage-controlled stimulation amplitudes in two experimental cohorts. The feasibility of this transcutaneous-guided stimulation was assessed acutely and at intervals up to eight weeks postimplantation.
Externally-driven HMSE stimulation produced distal limb motor responses and significantly lowered visible motor response thresholds compared with surface electrode stimulation without HMSE. Intraoperative stimulation thresholds measured using the HMSE delivery system were strongly associated with implanted HMSE thresholds (pig-adjusted correlation r = 0.779). Simple fluoroscopy-guided removal was successfully demonstrated at the terminal time point.
These findings demonstrate the feasibility of the externally-driven HMSE as a simple, minimally invasive, injectable neural interface that can be powered entirely through the skin using a standard surface TENS electrode, with no wires crossing the skin. We showed chronic stimulation capability for up to eight weeks and straightforward implant removal, supporting the HMSE's potential as a low-burden solution for peripheral nerve modulation.

PMID:
43013378
Bibliographic data and abstract were imported from PubMed on 12 Nov 2026.

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