What components make up the OpenNerve Platform?
OpenNerve consists of an implantable pulse generator (IPG) designed for closed loop bioelectronic medicine and several leads. Clinical leads currently offered by CARSS include a nerve cuff sized for vagus nerve stimulation, a linear 4-electrode lead designed for sacral nerve stimulation, needle electrodes for EMG, an ECG lead able to be placed under the sternum, and a motion sensor for placement on organs. Research leads are also under development, include a sub-mm thin film nerve cuff, a strain sensor, a sensor for end-organ temperature, and chemical sensors for acetylcholine, catecholamines, and pH levels.
How are the OpenNerve components manufactured?
The IPG and clinical leads are manufactured by Med-Ally at an ISO 13485 certified facility in South Carolina. Research leads are made at the University of Southern California.
What files are available online?
CARSS is posting all source files for OpenNerve on our GitHub page, including PCBA schematics and layouts, CAD models, and code for software and firmware.
What can I do with the files? Do I need to license the design?
All source files for OpenNerve are released under an open-source copyright license, Creative Commons CC-BY 4.0. This license allows anyone to use, modify, and distribute the files for any purpose, commercial or academic. The only requirement is giving proper credit to CARSS if the files are used.
What are the OpenNerve IPG’s capabilities?
The OpenNerve IPG is designed for closed-loop bioelectronic medicine and can support up to 8 bipolar stimulation channels and a number of analog front ends for biosignals. It also contains a Bluetooth antenna for control and data streaming. For a full list of capabilities please download our IPG flyer below.
Can OpenNerve be used in rodents or small animals?
While the full OpenNerve IPG may be a bit too large for small animal research, CARSS is currently supporting multiple projects in rodents and other small animals using percutaneous leads and an unpackaged OpenNerve PCBA. Using the OpenNerve PCBA at the small animal stage of research helps de-risk a new therapy when moving to large animals or chronic implantation. Contact us if you’re interested in utilizing OpenNerve for small animal research and we can work with you to find the best way forward.
Are there any ways to lower cost for early stage research?
For developmental research there are a number of ways to lower costs while still using the full capabilities of OpenNerve. These may include manufacturing the IPG out of PEEK instead of titanium, soldering leads directly to the PCB instead of using Bal-Seal connectors, and/or using a primary cell instead of a rechargeable battery. CARSS is happy to work with you to find the best way to move your project forward while setting it up for success in future GLP and clinical studies.
Can you make custom electrodes? Custom firmware? Custom electronics?
We absolutely can customize aspects of OpenNerve. The teams at Med-Ally and Medipace are experts on electrode, electronics, software, and firmware development for implanted neuromodulation devices and can modify OpenNerve to fit your project.
How much will OpenNerve components cost? Will there be a long lead time?
OpenNerve is still getting started, and we are working with collaborators individually to quote devices and allocate resources. On average, the IPGs should cost about ~$8k and leads will cost between $500-$1k for clinical grade devices. Lead times will be approximately 1 month, assuming there are no supply chain issues with component acquisition. For developmental study, we plan to provide PCBAs at cost (around ~$2.6k each) to groups interested in developing translational therapies with OpenNerve.
What funding mechanisms can I use to support development?
CARSS has partnered with both academic and commercial groups on a number of funding mechanisms, including SBIR/STTRs, NIH Blueprint Medtech funding, an R18 through NIH BRAIN or HEAL, or an R01/R21. We are also more than happy to work with groups supported by private funding or through another funding mechanism relevant to your project.
Who should I contact about working with CARSS?
For any questions or to get more information don’t hesitate to reach out! You can send a message to carss@usc.edu!
University of Southern California
1002 West Childs Way MCB-496
Los Angeles, CA 90089-1111
E: carss@usc.edu