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Implantation and Control of Wireless, Battery-free Systems for Peripheral Nerve Interfacing
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ReStore: A wireless peripheral nerve stimulation system.

Vishnoukumaar Sivaji1, Dane W Grasse2, Seth A Hays3

  • 1The University of Texas at Dallas, Erik Jonsson School of Engineering and Computer Science, Department of Bioengineering, 800 West Campbell Road, Richardson, TX 75080-3021, United States; The University of Texas at Dallas, Texas Biomedical Device Center, 800 West Campbell Road, Richardson, TX 75080-3021, United States.

Journal of Neuroscience Methods
|March 9, 2019
PubMed
Summary
This summary is machine-generated.

The ReStore system is a novel, leadless, battery-less wireless nerve stimulator designed for improved safety and reliability in neuromodulation therapies. This implantable device shows promise for effective peripheral nerve activation and biocompatibility in humans.

Keywords:
Implantable pulse generatorIntegrated electrodesNerve stimulatorNeuromodulationTelemetryWireless

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Area of Science:

  • Biomedical Engineering
  • Neuroscience
  • Medical Devices

Background:

  • Neuromodulation is increasingly used for neurological disorders.
  • Current implantable nerve stimulators face safety and reliability challenges, often requiring revision surgeries due to battery or lead failures.
  • Existing battery-less prototypes often use custom components, hindering clinical translation.

Purpose of the Study:

  • To introduce and evaluate the ReStore system, a miniature, implantable wireless nerve stimulator.
  • To assess the operational performance, efficacy, and long-term biocompatibility of the ReStore system.
  • To demonstrate a clinically translatable solution for peripheral neuromodulation.

Main Methods:

  • Description of the ReStore system: a battery-less, leadless, wireless implantable nerve stimulator.
  • Bench and in vivo testing to evaluate operational performance and nerve recruitment efficacy.
  • Large-animal chronic implantation study to assess long-term biocompatibility and hermeticity.

Main Results:

  • The ReStore system reliably delivered accurate, charge-balanced, biphasic current pulses across various loads.
  • Effective peripheral nerve activation was demonstrated, even after accelerated aging and chronic implantation.
  • Biocompatibility and hermeticity tests indicated potential safety for human use.

Conclusions:

  • The ReStore system offers a promising advancement in peripheral neuromodulation.
  • Its design, utilizing commercial components and wireless programming, addresses limitations of current technologies.
  • The system's performance and safety profile suggest potential for improved patient outcomes in neurological disorder treatment.