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Augmented Transcutaneous Stimulation Using an Injectable Electrode

View ORCID ProfileNishant Verma, Robert D Graham, Jonah Mudge, James K Trevathan, Manfred Franke, Andrew J Shoffstall, Justin Williams, Ashley N Dalrymple, Lee E Fisher, Doug J Weber, Scott F Lempka, Kip A Ludwig
doi: https://doi.org/10.1101/2021.09.29.462482
Nishant Verma
1Department of Biomedical Engineering, University of Wisconsin – Madison, Madison, WI, USA
2Wisconsin Institute for Translational Neuroengineering (WITNe) – Madison, Madison, WI, USA
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  • ORCID record for Nishant Verma
  • For correspondence: 96.nishant@gmail.com
Robert D Graham
3Department of Biomedical Engineering, University of Michigan, Ann Arbor, MI, USA
4Biointerfaces Institute, University of Michigan, Ann Arbor, MI, USA
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Jonah Mudge
1Department of Biomedical Engineering, University of Wisconsin – Madison, Madison, WI, USA
2Wisconsin Institute for Translational Neuroengineering (WITNe) – Madison, Madison, WI, USA
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James K Trevathan
1Department of Biomedical Engineering, University of Wisconsin – Madison, Madison, WI, USA
2Wisconsin Institute for Translational Neuroengineering (WITNe) – Madison, Madison, WI, USA
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Manfred Franke
5NeuronOff Inc., Valencia, CA, USA
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Andrew J Shoffstall
6Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH, USA
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Justin Williams
1Department of Biomedical Engineering, University of Wisconsin – Madison, Madison, WI, USA
2Wisconsin Institute for Translational Neuroengineering (WITNe) – Madison, Madison, WI, USA
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Ashley N Dalrymple
7Department of Mechanical Engineering, Carnegie Mellon University, Pittsburgh, PA, USA
8Rehab Neural Engineering Labs (RNEL), Department of Physical Medicine and Rehabilitation, University of Pittsburgh, Pittsburgh, PA, USA
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Lee E Fisher
8Rehab Neural Engineering Labs (RNEL), Department of Physical Medicine and Rehabilitation, University of Pittsburgh, Pittsburgh, PA, USA
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Doug J Weber
7Department of Mechanical Engineering, Carnegie Mellon University, Pittsburgh, PA, USA
8Rehab Neural Engineering Labs (RNEL), Department of Physical Medicine and Rehabilitation, University of Pittsburgh, Pittsburgh, PA, USA
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Scott F Lempka
3Department of Biomedical Engineering, University of Michigan, Ann Arbor, MI, USA
4Biointerfaces Institute, University of Michigan, Ann Arbor, MI, USA
9Department of Anesthesiology, University of Michigan, Ann Arbor, MI, USA
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Kip A Ludwig
1Department of Biomedical Engineering, University of Wisconsin – Madison, Madison, WI, USA
2Wisconsin Institute for Translational Neuroengineering (WITNe) – Madison, Madison, WI, USA
10Department of Neurosurgery, University of Wisconsin – Madison, Madison, WI, USA
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Abstract

Minimally invasive neuromodulation technologies seek to marry the neural selectivity of implantable devices with the low-cost and non-invasive nature of transcutaneous electrical stimulation (TES). The Injectrode® is a needle-delivered electrode that is injected onto neural structures under image guidance. Power is then transcutaneously delivered to the Injectrode using surface electrodes. The Injectrode serves as a low-impedance conduit to guide current to the deep on-target nerve, reducing activation thresholds by an order of magnitude compared to using only surface stimulation electrodes. To minimize off-target recruitment of cutaneous fibers, the energy transfer efficiency from the surface electrodes to the Injectrode must be optimized.

TES energy is transferred to the Injectrode through both capacitive and resistive mechanisms. Electrostatic finite element models generally used in TES research consider only the resistive means of energy transfer by defining tissue conductivities. Here, we present an electroquasistatic model, taking into consideration both the conductivity and permittivity of tissue, to understand transcutaneous power delivery to the Injectrode. The model was validated with measurements taken from (n=4) swine cadavers. We used the validated model to investigate system and anatomic parameters that influence the coupling efficiency of the Injectrode energy delivery system. Our work suggests the relevance of electroquasistatic models to account for capacitive charge transfer mechanisms when studying TES, particularly when high-frequency voltage components are present, such as those used for voltage-controlled pulses and sinusoidal nerve blocks.

Competing Interest Statement

JW and KAL are scientific board members and have stock interests in NeuroOne Medical Inc., a company developing next generation epilepsy monitoring devices. JW also has an equity interest in NeuroNexus technology Inc., a company that supplies electrophysiology equipment and multichannel probes to the neuroscience research community. SFL has equity in Hologram Consultants, LLC, is a member of the scientific advisory board for Abbott Neuromodulation, and receives research support from Medtronic, Inc. SFL also holds stock options, received research support, and serves on the scientific advisory board of Presidio Medical, Inc. KAL is also a paid member of the scientific advisory board of Cala Health, Blackfynn, Abbott and Battelle. KAL also is a paid consultant for Galvani and Boston Scientific. KAL, MF, and AJS are co-founder of NeuronOff Inc, which is commercializing the Injectrode®.

Footnotes

  • Updated version with minor corrections before submission to journal.

Copyright 
The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.
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Posted October 17, 2021.
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Augmented Transcutaneous Stimulation Using an Injectable Electrode
Nishant Verma, Robert D Graham, Jonah Mudge, James K Trevathan, Manfred Franke, Andrew J Shoffstall, Justin Williams, Ashley N Dalrymple, Lee E Fisher, Doug J Weber, Scott F Lempka, Kip A Ludwig
bioRxiv 2021.09.29.462482; doi: https://doi.org/10.1101/2021.09.29.462482
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Augmented Transcutaneous Stimulation Using an Injectable Electrode
Nishant Verma, Robert D Graham, Jonah Mudge, James K Trevathan, Manfred Franke, Andrew J Shoffstall, Justin Williams, Ashley N Dalrymple, Lee E Fisher, Doug J Weber, Scott F Lempka, Kip A Ludwig
bioRxiv 2021.09.29.462482; doi: https://doi.org/10.1101/2021.09.29.462482

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