# Development of Novel, Flexible Printed Lead Body for Use in Minimally Invasive Pain Management Systems

> **NIH VA I21** · LOUIS STOKES CLEVELAND VA MEDICAL CENTER · 2024 · —

## Abstract

The aim of this proposal is to design, fabricate, and test a novel, flexible printed lead body for chronic
implantation as part of peripheral nerve stimulation systems. Treatment modalities that require nerve stimulation
include restoration of motor control and sensation following paralysis or amputation, and chronic pain
management.
 This study will focus on the use of NanoJetTM technology to print electronic traces with a novel design
that will allow for strain relief under static and cyclic loading conditions. The flexible, printed lead body will be
comprised of a flexible substrate, printed metallic ink, and protective barrier to allow for chronic functional and
mechanical reliability. The lead body design will be created to connect with a percutaneous pain management
system of which the mating ends will be customized for the application. Tasks to be accomplished under this
proposal include the design, fabrication, and characterization of the device and its connecting ends. Long-term
structural biocompatibility will be assessed through a series of static and cyclic mechanical tests and in vitro
experiments that will establish chronic functionality. Passive implantation of the device will also provide
information on general biocompatibility. Data collected through evaluations made with test specimens will feed
into the design optimization process and data from full device testing will facilitate future applications to the FDA
to perform follow-on animal studies and future clinical work.
 The proposed effort seeks to improve rehabilitative patient care and the quality of life of Veterans through
the advances associated with the flexible, printed lead body. Implantable neurostimulation systems with high
channel counts provide the best option for nerve selectivity, and if those can be provided in a robust, miniaturized
system that allows for a minimally invasive procedure, then new opportunities for the development of
percutaneous pain management can be realized. Additionally, existing implantable systems for neurostimulation
may benefit from the high-density flexible lead, which would minimize the concerns related to complex
implantation procedures and larger volumes of implanted materials for the same number of channels.

## Key facts

- **NIH application ID:** 10950280
- **Project number:** 5I21RX003736-03
- **Recipient organization:** LOUIS STOKES CLEVELAND VA MEDICAL CENTER
- **Principal Investigator:** Janet L Gbur
- **Activity code:** I21 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2024
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2022-01-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10950280

## Citation

> US National Institutes of Health, RePORTER application 10950280, Development of Novel, Flexible Printed Lead Body for Use in Minimally Invasive Pain Management Systems (5I21RX003736-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10950280. Licensed CC0.

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