Clinical translation of ultrasoft Fleuron™ probes for stable, high-density, and bidirectional brain interfaces
Bibliographic record
Abstract
Building brain foundation models to capture the underpinning neural dynamics of human behavior requires large functional neural datasets for training, which current implantable Brain-Computer Interfaces (iBCIs) cannot achieve due to the instability of rigid materials in the brain. How can we realize high-density neural recordings with wide brain region access at single-neuron resolution, while maintaining the long-term stability required? In this study, we present a novel approach to overcome these trade-offs, by introducting Fleuron, a family of ultrasoft, ultra-low-k dielectric materials compatible with thin-film scalable microfabrication techniques. We successfully integrate up to 1,024 sites within a single minimally-invasive Fleuron depth electrode. The combination of the novel implant material and geometry enables single-unit level recordings for 18 months in rodent models, and achieves a large number of units detected per electrode across animals. 128-site Fleuron probes, that cover 8x larger tissue volume than state-of-the-art polyimide counterparts, can track over 100 single-units over months. Stability in neural recordings correlates with reduced glial encapsulation compared to polyimide controls up to 9-month post-implantation. Fleuron probes are integrated with a low-power, mixed-signal ASIC to achieve over 1,000 channels electronic interfaces and can be safely implanted in depth using minimally-invasive surgical techniques via a burr hole approach without requiring specialized robotics. Fleuron probes further create a unique contrast in clinical 3T MRI, allowing for post-operative position confirmation. Large-animal and ex vivo human tissue studies confirm safety and functionality in larger brains. Finally, Fleuron probes are used for the first time ever intraoperatively during planned resection surgeries, confirming in-human usability, and demonstrating the potential of the technology for clincical translation in iBCIs.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".