Community Research and Development Information Service - CORDIS

H2020

CARDIS Report Summary

Project ID: 644798
Funded under: H2020-EU.2.1.1.6.

Periodic Reporting for period 1 - CARDIS (Early stage CARdio Vascular Disease Detection with Integrated Silicon Photonics)

Reporting period: 2015-02-01 to 2016-04-30

Summary of the context and overall objectives of the project

A. Context

Cardiovascular disease (CVD) encompasses diseases of the heart and of the vessels (mainly arteries) connecting organs and tissues to the blood circulation. It primarily encompasses diseases of the arteries directing blood to the brain (cerebrovascular disease) and to the heart (the coronary arteries). CVD and their risk factors are the major contributors to global morbidity and mortality. CVDs are responsible for over 17.5 million deaths per year worldwide, representing 31% of all global deaths . Early identification of individuals at risk for Cardiovascular Diseases (CVD) allows early intervention to delay, halt or reverse the pathological process.

Assessment of arterial stiffness by measurement of aortic pulse wave velocity (aPWV) is included in the latest guidelines for cardiovascular risk prediction – arterial stiffness is an early marker for hypertension. Early identification of arterial stenosis and heart dyssynchrony (abnormalities in the synchronization between the heart chambers) can be used to improve CVD risk classification. However, no tools are available today to screen a large population under primary care for these indicators, and individuals that are considered to be at low or moderate risk are too often undiagnosed.

Over the past few years, The University of Gent and Queen Mary University of London and others have gathered evidence that mechanical vibrations induced by cardiovascular dynamics actually propagate up to skin level, where they can be picked up using contact measurements or non-contact measurements such as laser Doppler vibrometry.

A laser Doppler vibrometer (LDV) is an instrument that is used to make non-contact vibration measurements of a surface. The laser beam from the LDV is directed at the surface of interest and vibration amplitude and frequency are extracted from the Doppler shift of the reflected laser beam frequency due to the motion of the surface. Three approaches are followed:

• Targeting the skin overlying an artery enables detection of skin vibrations induced by the flow in the artery. A stenosis in the artery will change the flow pattern and thereby change the frequency of the vibration propagating to the skin level.
• Targeting two adjacent points of an artery enables measurement of the time it takes the pulse beat to travel between the two points of the artery from which pulse wave velocity (aPWV) can be derived.
• Targeting the chest allows for detection of skin vibrations induced by the heart pumping action. Dyssynchrony will change the vibration pattern.

B. Overall objectives

The objective of CARDIS is to investigate and demonstrate the concept of a mobile, low-cost CVD screening device based on a silicon photonics integrated laser vibrometer and to validate the concept for the screening of arterial stiffness, detection of stenosis and heart dyssynchrony.

The objective will be met by:

• Investigating, designing and fabricating optical subsystems and components:
- A Photonic Integrated Chip with a multi-branch laser interferometer with integrated photo detectors and input port for an external micro-optical laser assembly
- A micro-optical laser assembly
- A micro-optical lens system
• Integrating the subsystems and build a multi-beam laser Doppler vibrometer
• Developing a process flow scalable to high volumes for all sub-systems and their integration steps
• Investigating and developing the biomechanical model to translate optical signals related to skin-level vibrations into underlying CVD physiological events
• Validating the system in a clinical setting.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

C. Work performed during Period 1

Pulse wave velocity (PWV) and skin vibrations induced by the pulsatile flow in the carotid artery have been measured in a pilot study using a dual-beam interferometer based on commercial LDV technology.

A first version of a demonstrator device has been designed. The device is a multi-beam LDV instrument designed for pulse wave velocity and skin vibration measurement. The beams are laid out in two rows, each consisting of 6 beams to enable robust targeting of the carotid artery. The demonstrator device is designed for validation of basic functionality in a laboratory setting including PWV and vibration measurements on a biomechanical model of a carotid artery in soft tissue.

The demonstrator device utilizes advanced techniques within the field of photonics chip manufacturing, advanced photonics assembly techniques, micro-optical design and signal processing.

All subcomponents of the system are in fabrication. In particular the silicon photonics chip – the heart of the system – is being fabricated by means of the iSiPP25G silicon photonics platform of imec through the Multi-Project-Wafer service organized by the Europractice IC-service. The chip contains photonic circuitry, phase tuners and photodetectors. The light source for the system is a custom-designed micro-optic-bench system that will be mounted on the silicon chip. The imaging system between the silicon chip and the target (skin) is a custom-designed micro-optic lens system.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

D. Progress beyond the state of the art and expected potential impact

With Medtronic, SIOS, imec, Tyndall-UCC, the Universiteit Gent (UGent), Queen Mary University of London (QMUL), INSERM and the Universiteit Maastricht (UM), CARDIS is partnering European leaders in respectively medical devices, laser interferometers, silicon photonics and arterial biomechanics. CARDIS will help to secure their leadership by developing a new application that advances the existing background. In this collaboration, the partners will be sharing their experience and background for the purpose of creating a state-of-the-art CVD screening device that they would not be able to develop alone and in the same timeframe.

The possibility for earlier detection of risk for CVD makes it possible to start earlier treatment. In these early stages of the disease this could be achieved simply by a change in life style and/or relatively cheap cholesterol lowering drugs such as statins. Thus, more complicated treatments, like stenting and ultimately cerebral and myocardial infarction may be prevented.

CARDIS will enable Medtronic to enter a new market segment and extend its Diagnostic business, currently focused on Implantable Cardiac Monitors. SIOS is a growing company and needs to develop new markets. The project will enable SIOS to enter the medical market.

The new knowledge and expertise developed by imec, UGent, Tyndall-UCC and QMUL in CARDIS will be made available to EU companies in the medical diagnostics market and other markets. It will be used to bring integrated photonics to the next level, opening its use to all kind of applications. It is the Corporate Mission of these institutions to transfer technology to industrial partners so as to create an economical and societal impact with the developed technology.

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