The objective of InSiDe is to provide access for the medical community to a new diagnostic device, based on a silicon photonics integrated homodyne laser interferometer, able to identify and characterize different stages of cardiovascular diseases proving its efficacy to drive an indicated therapy institution and to monitor its follow-up, in order to reduce the healthcare costs and improve patients outcome.
The objective of the InSiDe project is to take the CARDIS device a major step further towards commercialization by means of the following steps:
1. Development and release of a true handheld wireless clinical investigational device with capability to
- Measure carotid-femoral PWV as a measure for arterial stiffness and present results on the display of the device.
- Quantify arterial stenosis and present results on the display of the device.
- Record cardiac contraction patterns and present trace with marked fiducial points and timing between those.
- Transfer recorded data to an external computer for scientific purposes and algorithm verification.
2. To demonstrate in clinical feasibility studies with the developed clinical investigational device that it is useful for GPs and cardiologists.
3. The target for the developed InSiDe device is a handheld, battery-operated split device, which can be operated as one unit as well as two separate units and can conduct timed recordings in order to derive pulse transit times between traces recorded with the two units. The device is based on a 4-beam laser Doppler interferometer in each demonstrator half part. Objective of the device development is to:
- Eliminate the need for a single-use retro-reflective patch on the measurement locations. (used in the CARDIS project (link to www.cardis-h2020.eu)
- Design wavelength 1.3 μm to assist the direct detection from human skin
- Use Silicon-on-Insulator photonics technology to manufacture the 4-beam LDV chip.
- Integrated spacer for robust measurement of the targeted cardiovascular feature (superficial artery, chest cage for heart contraction patterns).
- Use wireless connection between devices and to external computer/smart phone and the like.
- Establish synchronous timing between parts of split device with regards to pulse transit time measurements when using a wireless connection.
- Develop a sealed photonics package with a 4-beam LDV chip, a 1.3 μm laser and aligned optical system built using manufacturing processes suitable for high volume production.
- Interferometer control and signal processing electronics integrated in the handheld device half parts.
- Algorithms running in processors integrated into the handheld split device for real-time or near-real-time signal processing to eliminate the need for massive storage of data.
- Touch screen interface.