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Standard Leads

Repo: CARSSCenter/OpenNerve-Standard-Leads

Not approved for human use

Nothing described on this page has regulatory clearance for human use. See Regulatory status and disclaimers.

Image of standard leads with scale bar

Three of the standard leads manufactured by Med-Ally. Top: a 2mm diameter bipolar nerve cuff. Middle: an intramuscular EMG lead with integrated suture. Bottom: a linear array for SNS or SCS.

What they are

A library of leads that interface with the OpenNerve IPG, designed to be manufacturable under GMP by Med-Ally LLC using standard manufacturing processes:

  • VNS cuff electrode — two radial platinum-iridium electrodes, 1 mm wide, 6 mm spacing, in a silicone cuff. Targets nerves 1–3.5 mm in diameter (e.g. cervical vagus).
  • SNS linear electrode — four platinum-iridium electrodes, 3 mm wide, 3 mm spacing, with anchor features for in vivo positioning. Targets sacral or other peripheral nerve stimulation.
  • EMG needle electrode — platinum-iridium needle electrode with suture needle; two can be paired for bipolar recording.
  • ECG electrode — two electrodes, 3 mm long, 80 mm spacing, based on the Boston Scientific 3400 S-ICD lead.
  • AMS motion sensing lead — an MIS2DH accelerometer encapsulated in silicone, communicating with the IPG over I2C.

(source)

Maturity

Evidence E3 Chronic in vivo

Manufacturing readiness M3 GMP-capable

Documentation

Nest 3 design files

Four PDFs at the top level of the repo cover the mechanical design, specifications, and test plan for all five leads. Each viewer below fetches its PDF live from the repo's default branch — click a title to expand it:

Design File Set

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Mechanical Specifications

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Test Plan

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Mechanical Design and Assembly Images

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AMS lead PCBA

The AMS motion-sensing lead carries its own board ("XLBoard") holding the MIS2DH accelerometer. The drawings below are the current revision (Ver 1.1 Rev A, July 2025):

Schematic

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Board layout and fabrication drawing

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An earlier revision of the XLBoard schematic and layout is retained upstream in the repo's AMS Lead PCBA/Old/ folder and is not reproduced here.