Section: New Results

Spin-off Neurinnov

Participants : David Andreu, David Guiraud, Olivier Climent, Milan Demarcq, Guillaume Souquet.

Thanks to the support of the Inria-DGDT, the spin-off Neurinnov has started the industrialization of the innovative technology developed in CAMIN, a new generation of active implantable medical device (AIMD). Neurinnov has been awarded with the i-Lab 2017 prize by the French Minister of Research and Innovation, that encourage the most innovative and promising startups in France. Moreover, Neurinnov is accredited by the Business Incubation Center of Montpellier and incubated by the Languedoc-Roussillon Incubation Center.

Industrialization means on the one hand the development of an industrial version of the technology with all the regulatory documents required by the Technical Documents part of the CE certification, and on the other hand the setting up of our own system of quality management in accordance with ISO 13485. Since the beginning the spin-off has to consider regulatory aspects, of which the quality management system (QMS). A QMS is a set of policies, processes and procedures designed to help an organization to consistently provide safe and effective medical devices, and to comply with customer and regulatory requirements. Thus the team worked on defining processes and associated procedures regarding for instance the design, the development and the verification of our stimulation device.

The design and verification of the two parts of our AIMD (stimulator), namely the digital part (FPGA) and the analogue part (ASIC), were carried out in accordance with the defined procedure and applicable standards.

The core of the stimulators developed in the CAMIN team are based on an Application Specific Integrated Circuit (ASIC). It includes both the analog part with the generation of 12 current sources that are able to drive a pulticontact electrode. The global ASIC architecture fully implements our patent and allows to spread the current from a unique current source over the 12 outputs through ratios programming. This unique feature is a consequence of researches about the multicontact selective stimulation through neural cuffs. In the new 0.18µ new design, the analog part was entirely revised to enhance power consumption and global analogue features. On the digital aprt the concept of virtual electrode was fully implemented within this ASIC (named CORAIL) to embed all the low level programming parts dedicated to the spreding of the current. It enhances the safety but also the efficacy of the code developed to control this ASIC as it virtualize the concept of ratios. Moreover CORAIL stores the Virtual Electrode so that the needed bandwidth but also the transfer time between CORAIL and the hiigh level control is much lowered compared to the previous version we developed. We tested and implemented this original digital part in collaboration with the micro-electronics department at LIRMM and SL3J company. A first version of the ASIC was made and is under investigation to prepare the next version.

The digital part of the device embeds a set of functionalities (described section 5.1.1) allowing the stimulator to be programmable, communicating and fully controllable remotely. The formal design and verification of this digital part is based on the HILECOP software developed within CAMIN (see sections 5.1.1 and 6.7). All constituent components have been developed, verified and documented in accordance with the defined procedure.

In addition, Neurinnov has focused on setting up the necessary industrial collaborations on the one hand to complement its device (e.g., electrodes, connectors) and on the other hand to manufacture it.