ABSTRACT
This article deals with the long-term preclinical validation of WIMAGINE® (Wireless Implantable Multi-channel Acquisition system for Generic Interface with Neurons), a 64-channel wireless implantable recorder that measures the electrical activity at the cortical surface (electrocorticography, ECoG). The WIMAGINE® implant was designed for chronic wireless neuronal signal acquisition, to be used e.g., as an intracranial Brain-Computer Interface (BCI) for severely motor-impaired patients. Due to the size and shape of WIMAGINE®, sheep appeared to be the best animal model on which to carry out long-term in vivo validation. The devices were implanted in two sheep for a follow-up period of 10 months, including idle state cortical recordings and Somato-Sensory Evoked Potential (SSEP) sessions. ECoG and SSEP demonstrated relatively stable behavior during the 10-month observation period. Information recorded from the SensoriMotor Cortex (SMC) showed an SSEP phase reversal, indicating the cortical site of the sensorimotor activity was retained after 10 months of contact. Based on weekly recordings of raw ECoG signals, the effective bandwidth was in the range of 230 Hz for both animals and remarkably stable over time, meaning preservation of the high frequency bands valuable for decoding of the brain activity using BCIs. The power spectral density (in dB/Hz), on a log scale, was of the order of 2.2, -4.5 and -18 for the frequency bands (10-40), (40-100), and (100-200) Hz, respectively. The outcome of this preclinical work is the first long-term in vivo validation of the WIMAGINE® implant, highlighting its ability to record the brain electrical activity through the dura mater and to send wireless digitized data to the external base station. Apart from local adhesion of the dura to the skull, the neurosurgeon did not face any difficulty in the implantation of the WIMAGINE® device and post-mortem analysis of the brain revealed no side effect related to the implantation. We also report on the reliability of the system; including the implantable device, the antennas module and the external base station.
ABSTRACT
A wireless 64-channel ElectroCorticoGram (ECoG) recording implant named WIMAGINE(®) has been designed for clinical applications. This active implantable medical device is able to record ECoG on 64 electrodes with selectable gain and sampling frequency, with less than 0.7 µVRMS input referred noise in the [0.5 Hz - 300 Hz] band. It is powered remotely through an inductive link at 13.56 MHz, communicates wirelessly on the MICS band at 402-405 MHz with a custom designed base station connected to a PC and complies with the regulations applicable to class III AIMD. The design of the housing and the antenna have been optimized to ease the surgery and to take into account all the requirements of a clinical trial in particular patient safety and comfort. The main features of this WIMAGINE(®) implantable device and its architecture will be presented, as well as its performances and in vivo validations.
