Abstract
This disclosure describes GCI NeuroRegenerator v2.1, a conceptual clinic–home hybrid platform that combines low‑intensity focused ultrasound (LIFUS) neuromodulation with extracorporeal plasma purification and non‑invasive vascular and ocular wearables to support treatment of neurodegenerative and vascular brain diseases. The clinic unit uses a 250–500 kHz LIFUS console built to IEC 60601‑2‑37 and FDA ultrasound exposure limits (ISPTA ≤ 720 mW/cm², MI < 1.9) to deliver short, weekly neuromodulation sessions to targets such as prefrontal cortex and hippocampus, following parameters reported in recent MCI, Alzheimer’s, and Parkinson’s trials. An optional plasma purification module, modeled on dialysis‑grade standards, incorporates disposable, gamma‑sterilized cartridges and sensor‑based controls to reduce inflammatory cytokines (e.g., IL‑6, TNF‑α) in a controlled, clinic‑only setting.
The home component consists of two low‑energy wearables: a Stealth‑Vortex Vascular Purifier (SVVP) patch for peripheral and carotid flow support and an Ocular Microstreaming Scrubber (OMS) contact‑lens form factor for vitreous and visual comfort. These devices operate under FDA “general wellness” positioning, with no diagnostic or therapeutic claims, and are physically air‑gapped from any high‑voltage ultrasound drivers. A triple‑gate safety architecture—eFuse identity flag, secure boot with signed firmware, and a physician NFC token—prevents any home unit from being repurposed for brain‑directed FUS or plasma access.
The disclosure includes an ISO 14971:2019 risk management matrix, an IEC 60601‑1 electrical and mechanical safety checklist, acoustic V&V protocols using hydrophone and phantom testing, fluidic safety checks for the plasma loop, and a final verification checklist aligned with the 2026 FDA Quality Management System Regulation (QMSR). GCI NeuroRegenerator v2.1 is explicitly presented as a concept‑stage engineering blueprint and defensive publication, not as a validated or approved medical device. It is intended to serve as open prior art for future clinical developers under the CERN‑OHL‑P and CC‑BY 4.0 licensing model.
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.
Recommended Citation
Caldwell, Michael Victor Mr., "GCI NeuroRegenerator v2.1: Clinic–Home Hybrid Platform For Low‑Intensity Ultrasound Neuromodulation And Vascular Support", Technical Disclosure Commons, ()
https://www.tdcommons.org/dpubs_series/9591