Abstract
This disclosure describes GCI‑267, a harmonized control and safety platform that coordinates four separate, physically grounded medical technology modules into a single, multi‑organ support system. The platform integrates: (1) a spiral inertial microfluidic module for size‑based separation of larger aggregates and cells in blood or cell suspensions (GCI‑260), using Dean‑flow spiral microchannels similar to current label‑free circulating tumor cell (CTC) devices; (2) a low‑frequency (around 1 MHz) ultrasound patch for vascular clot‑support applications (GCI‑261), inspired by existing sonothrombolysis work combining ultrasound and microbubbles to enhance enzymatic thrombolysis; (3) a 1–5 MHz ocular ultrasound module for experimental fragmentation of vitreous floaters (GCI‑262), based on acoustic fragmentation and phaco‑like mechanical effects at reduced intensity; and (4) a low‑intensity focused ultrasound (LIFUS) neuromodulation module for clinic‑only use (GCI‑263), aligned with parameters used in contemporary stroke and cognitive‑impairment neuromodulation trials.
GCI‑267 is not a new therapeutic mechanism by itself; instead, it provides the multi‑channel power distribution, waveform generation, timing, and safety supervision necessary to operate these four modules together without interference. The controller enforces acoustic output limits consistent with IEC 60601‑2‑37 and FDA cranial ultrasound guidance (Mechanical Index below 1.9 and spatial‑peak time‑average intensity within recognized safety ranges), coordinates duty cycles and sequencing so thermal rise in tissue‑mimicking phantoms remains below 1 °C, and ensures that the neuromodulation module remains restricted to a clinic‑only environment while the other modules may be adapted to lab or supervised clinical use. The platform includes interfaces for peristaltic pumps and sensors for spiral microchannels, independent drive stages for each ultrasound frequency band, and a separate safety microcontroller capable of forcing a safe shutdown.
This invention is presented as an engineering architecture and defensive publication, not as a clinically validated or approved medical device. It builds on published work in spiral inertial microfluidics for size‑based cell separation, ultrasonic clot‑support systems, ocular acoustic fragmentation, and LIFUS neuromodulation, and proposes a unified controller that can drive these components as a synchronized system. The goal is to provide open, prior‑art disclosure of a harmonized, multi‑module ultrasound–microfluidic platform so that future developers can extend, test, and regulate such systems while avoiding fragmented, proprietary implementations.
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Recommended Citation
Caldwell, Michael Victor Mr., "GCI‑267 Harmonized Multi‑Module Ultrasound and Microfluidic Platform for Blood, Vascular, Ocular, and Brain Support", Technical Disclosure Commons, ()
https://www.tdcommons.org/dpubs_series/9593