Instrumentation for innovative cerdiovascular markers

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Instrumentation for Innovative Cardiovascular Markers

Publication . Bonifácio, Paulo Jorge dos Santos; Vassilenko, Valentina; Valtchev, Stanimir

Cardiovascular diseases (CVDs) are the leading cause of death, with more than 16 million of deaths per year. The World Health Organization (WHO) proposed a global plan for the prevention and control of Noncommunicable Diseases (NCDs) where is stated that actions for the risk mitigation for CVDs should begin with a full cardiovascular risk assessment during routine medical practice. Two main obstacles exist to this end; first there is no easy to use, universally accepted “gold-standard” indicator of arterial injury and cardiac disfunction; secondly, there is the need for the distribution of easy-to-use, cost-effective devices that allow for the monitoring of such indicators. One of the known indicators, the carotid-femoral pulse wave velocity (cfPWV), was proposed as the “gold-standard” measurement for arterial stiffness in the guidelines for management of arterial hypertension in 2007. Non-invasive sensors, such as photoplethysmography (PPG), planar tonometry or sphygmomanometer-cuff devices, can be used to this end. Within this framework, NMT, S.A. developed a noninvasive device for the monitoring and assessment of cardiovascular health. The VasoCheck® device comprises a suite of 4 wireless PPG sensors that allow for the recording and real time monitoring of the blood pulse waveform. The experience gathered during tests, validations, and measurement campaigns; the user feedback; the need to address a hardware obsolescence and to take the next steps for medical device certification and industrialization, along with the introduction of additional features, led to this project. For improving the device, the best practices for system development, requirements for verification, validation and certification of medical devices were reviewed., As well as the state-of-the art in the cardiac and blood pulse recording technology. The main aims of the work started by baselining the device at hardware, firmware, and architecture levels, (i.e., PPG sensors, communication modules, power supply, and ancillaries). Device limitations were investigated, and a development path was set. Existing units were subject to incremental improvements resulting in increased resilience. The integration of new sensor types was evaluated, specifically MEMS type microphones. A critical design review (CDR) was made., Several modules were redesigned and documented in a design-for-production paradigm, with increase roughness and to facilitate factory level assembly, serviceability, and recycling. A new architecture was developed to accommodate for multiple sensor types and to allow integration with future cloud-based health diagnostic support tools. Protocols for testing, calibration, maintenance were created. Ready-to-manufacture deliverables were complied. Finally, the necessary steps for medical device certification were identified and the process was started when it became possible.

2022-12-22Tese de doutoramento

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Fundação para a Ciência e a Tecnologia

Número da atribuição

PD/BDE/130083/2017