Open Nerve

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The OpenNerve project is an advanced open-architecture, open-source implantable neuromodulation system. Funded by the National Institutes of Health (NIH) under the Human Open Research Neural Engineering Technologies (HORNET) initiative, this project focuses on developing a sophisticated Implantable Pulse Generator (IPG) platform. The IPG is designed to perform current-based neuromodulation, measure impedance, monitor electronic biosignals, and interface with chemical and physical sensors. Our team at Focus is responsible for the electronics design, ensuring the system is robust, scalable, and adaptable for a wide range of neuromodulation therapies.

01

About the client

Medipace is a Pasadena (CA) based medical device start-up company developing implantable therapeutic devices for restoring health in people with gastrointestinal, auto-immune, and metabolic diseases. Their therapy is the sacral nerve stimulation, a well-established method of neuromodulation using an implantable pulse generator and electrodes implanted in the sacral region of the vertebral column.

02

About the problem

The challenge presented to Focus was to develop a versatile and reliable electronic platform for the OpenNerve project. The goal was to create an IPG that could support a wide array of neuromodulation therapies while being cost-effective and accessible through open-source distribution. The complexity of this project lay in integrating various sensing and stimulation capabilities within a compact, implantable device, ensuring it could perform accurately in the demanding environment of the human body.

03

Working Methodology

Our approach to the OpenNerve project was methodical and collaborative, adhering to an Agile development methodology to accommodate evolving needs. We began with a thorough consultation to understand the specific requirements and constraints of the system. Following this, our engineering team focused on iterative design and development cycles, allowing us to refine the hardware components progressively. Key milestones included the design of the initial IPG prototypes, rigorous bench testing, and ongoing collaboration with the client to ensure alignment with their clinical objectives. We utilized state-of-the-art design tools, ensuring the highest standards of precision and reliability.

04

The Solution

The solution we developed for the OpenNerve project is an IPG platform equipped with advanced sensing and neuromodulation capabilities. The hardware includes the Nordic Semiconductor nRF52832 microcontroller, selected for its low power consumption and robust wireless communication features. The IPG is capable of performing current-based neuromodulation, impedance measurement, and electronic biosignal monitoring. It also features interfaces for various chemical and physical sensors, allowing it to be adapted for different therapeutic applications. The embedded software was meticulously designed to manage these functions seamlessly, providing a reliable interface between the device and external controllers.

05

The Results

Although the project is ongoing, with pre-clinical trials scheduled for late 2024, the development of the OpenNerve platform has already achieved significant milestones. The IPG prototypes have demonstrated excellent performance in preliminary testing, showing great potential for use in a wide range of neuromodulation therapies. The project’s open-source nature has attracted interest from researchers and developers worldwide, promising to accelerate innovation in the field of neuromodulation. The collaboration has positioned Focus as a leader in the development of next-generation implantable medical devices, contributing to a project that could revolutionize the accessibility and affordability of neuromodulation therapies.

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