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In-vessel implantable smart sensing device for personalised medicine

Periodic Reporting for period 1 - IV-Lab (In-vessel implantable smart sensing device for personalised medicine)

Période du rapport: 2023-09-01 au 2024-08-31

The project aims to develop a multi-sensing device implantable into blood vessels, such as peripheral veins or arteries, to support the monitoring of body parameters and, thus, the health status of a person. Once implanted in patients with cardiovascular diseases, the microsensor system will implement a platform with multiple sensing capabilities, targeting hemodynamic and biochemical parameters. An overview of the final platform is reported in the attached image. The miniaturized sensing device that will be designed and developed will enable continuous monitoring not only of a single parameter but of a variety of them, providing comprehensive information about blood vessel and the health status of patients. Indeed, compared to other sensors already present in the literature or in the market, the new device will incorporate multiple sensors, all integrated into a platform measuring only 1-2 cm long and 2-4 mm in diameter. This overall integration, which represents one of the most innovative aspects of the project, is allowed using advanced fabrication techniques. These techniques enable, first, the fabrication of sensors at the microscale and, second, facilitate their transfer, assembly, and connection onto the supporting frame. The sensors will target the measurement of blood pressure, vessel deformation, oximetry, haematocrit as well as the detection of specific cardiovascular biomarkers. The primary objective -and the long-term vision of the project- is to remotely provide physicians with a high number of crucial information useful for rapid and early intervention against heart failures in patients. Indeed, the implanted system will be connected with (and powered by) an external data collection and communication system coupled through standardized wireless technology, or even simply by a smartphone in case of asynchronous on‐demand monitoring. The specific sensors that will be implemented within the project are a strain gauge for vessels deformation, pressure sensor for blood pressure and hemodynamics, micro-spectrometer for haematocrit and oximetry, micro electrodes for electrochemical detection, photonic crystal biosensor for glucose detection, organic transistors based biosensors for cardiac troponins (attached figure).
The main objective of the proposal is the development of the multisensory miniaturized device that can be implanted in vessels and transfer the measured data wirelessly. Other specific and measurable objectives are related to the development of each sensor, demonstrated through suitable and specific experimental proof-of-concept demos. Specifically, the development of each individual sensor and the achievement of its target values are objectives in themselves.
Concerning Objective I, currently, the user cases and specifications, which outline the basic use scenarios, specifications, and architecture for the final development of IV-Lab device, have been defined. A set of guidelines and strategies for assessing the platform, as well as the fabrication and integration of each sensor developed in three separate work packages, have been provided, marking the achievement of the project's first milestone. Furthermore, a discrete assembled version of the electronics sub-system has been studied, to check the design functionalities, also providing layouts and schematics for the integration of multiple sensors with control and communication electronics. These results demonstrate the feasibility of incorporating the sensors onto a compact, flexible platform, with dimensions (15 x 1.5 mm2).
Concerning the sub-objectives related to the implementation of the individual sensors, the architecture, the fabrication strategies, the readout electronics, and the integration processes have been defined for all of them. Some of the sensors have been preliminary prototyped at this stage to validate the proposed approach.
The work carried out so far led to the definition of all regulations, use cases, and barriers for real-life scenarios, as well as guidelines for the implementation of the miniaturized sensors. Some microscopic scale sensors have already been realized and are under characterization. Importantly, miniaturized electronics have been implemented and the possibility of integrating multiple sensors in a small-sized platform (15 mm x 1.5 mm) has been studied, demonstrating the feasibility of integrating sensors in a single miniaturized device.
Further results advancing the state of the art are expected to be achieved in the very next future.

The impact of the project is quite in line with the expectations set in one year of work. Below are the numerical indicators for different areas of impact:
Scientific area:
• Number (#) of scientific publications: 5 Done
• Number (#) of conference presentations: 23 Done
• Open Data available: Yes

Technological area:
• # direct contacts with network in industries: 2 - Bracco s.r.l. representatives (pharma and medical device company and ST Microelectronics representatives (Integrated electronics components and MEMS, also for medical application) both invited to join the project Advisory Board.
• # potential partnerships in new R&I initiatives: 1 submitted EIC Transition proposal partially based on IV-Lab technology (NFC miniaturized active micro-device)

The project is currently in an early stage to contribute to Healthcare sector indicators: demos will be issued once a prototype of the complete device will be ready and running. The project is in early stage to contribute to market indicators. Nevertheless, the possibility to patent some of the innovations produced within the project is under evaluation. Moreover, the project is involved in the EU Innovation Radar initiative.
Overview of the IV-LAB in vessel implantable multisensory device
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