ThrombUS+ D2.3: Technical and functional requirements

Deliverable 2.3 outlines the technical and functional requirements for a wearable system to monitor, detect, and prevent deep vein thrombosis (DVT). This was achieved through analysing contractual obligations, patient-centric use cases, regulatory frameworks, clinical guidelines, and clinician consultations, while ensuring methodological and technical feasibility.The analysis of over 190 literature sources revealed that a universal system integrating multiple measurement methods—compression duplex ultrasound, electrical impedance (EIP), and light reflection rheography (LRR)-based venous occlusion plethysmography—would be beneficial. These methods will share common modules, including a wearable tissue compression actuator (TCA) and a central hub (CHI) with software for medical specialists. An extended reality and serious game module (XGM) is also proposed for DVT prophylaxis.Key innovations include operator-independent, compression ultrasound scanning for DVT detection, which would replace manual monitoring. This method’s feasibility depends on vein visibility during scans, particularly in supine patients, with potential solutions involving automatic calf compression and Doppler ultrasound monitoring. Hydrogel disposable pads are suggested to address issues with drying ultrasound gel. In addition, EIP and LRR venous occlusion plethysmography will enable automated DVT screening while sharing the TCA across modalities. Investigational studies are needed to define optimal patient and sensor positioning. Exploring passive monitoring methods through mechanical or electrical stimulation may enhance venous flow.DVT prophylaxis is also emphasized, with the potential to improve venous flow through mechanical and/or electrical stimulation. Integrating serious games into the ThrombUS+ platform could enhance both prevention and rehabilitation for immobilized patients.The identified module-based requirements will inform the further development of the ThrombUS+ system, with detailed specifications to be outlined in Deliverable D6.1, “Product Design Specifications.”