D1.5 Periodic Interim Report

This document summarizes all the activities of Year 3 first semester. The main management activities has been devoted to the DoW amendment procedure, completed on March 27, 2012, as well as to the second review organization. Together with some peer review articles, a certain number of presentations to international conferences has represented the main dissemination work. A revised and integrated version of the D2.2 'Dissemination Activities, Scenarios of Use and Market Potential' has been released, by including a detailed section of exploitation possibilities and potential market of the SensorART main results. The final Users Requirement Analysis has been completed, together with the deliverable concerning clinical research on biomarkers. Clinical partners, faced by the actual scenario of VAD implantation in end stage heart failure (ESHF) patients and the new perspective of applications of SensorART project, are obliged to a progressive, cultural challenge. A list of the main issues are: choices of sensors and signals within the strict and multiple regulations relative to active, implantable devices, risk assessment of functioning and possible interferences in the global system architecture, compliance and coping of different patients respect to different sensorized platforms. Due to this complexity, a further refinement respect to the system architecture which is an ongoing, dynamic activity, appears mandatory, to overcome specific contingencies. The research area of biosensors has been dedicated to analyze plasma samples taken from HONIG's ESHF patients on standard gold microelectrodes. In parallel, some tests on artificial plasma have been also performed by obtaining reproducible results. For the implantable sensors, the main goal reached has been the in housed flow sensor in the CircuLite pump, while for wearable sensor the choice and the acquisition of sensorized MagIc t-shirt has characterized this period. For TET (transcutaneous energy transfer) some of the activities completed included: realization of a first prototype for investigating the principle behaviour of inductive powering in the midrange power range, measurements with a laboratory prototype and test bench for misalignment measurements, besides analytical and numerical circuit analysis, selection of compensation topology, design concept for a first prototype. As result of the first design phase, a first Laboratory Prototype of a self-stabilizing 30 W TET driving the CircuLite VAD and delivering additional 1 A current for a battery charger has been realized. Furthermore, the implementation of a demo prototype providing the necessary functionality for the first version of the API that will accommodate full interoperability with all continua alliance certified sensors has been obtained. The design and implementation was done for android devices, version 4.0.3 and higher, by considering that the android ecosystem represents a really high growing market and provides open source development tools. The ARU (autoregulation unit) activities have been devoted to the development of an independent auto-regulation unit module. The auto-regulation control algorithm is oriented to the implantable platform: this unit will allow the physician to access VAD and sensors parameters in order to adjust the pump speed according to different needs. Moreover, the auto-regulation unit is designed to monitor the energy consumption, as well as the VAD functionality, thus generating the appropriate crucial and vital alert messages. The definition of the wearable sensors and patient data acquisition for the open, VAD independent, wearable platform is an ongoing work. The acquired signals from the two platforms (implantable and wearable) is addressed to a PMA (Patient Monitoring Application) device via telemetry in order to monitor the implanted patient health. Furthermore, the assembly of an in-vitro platform was carried on during the reporting period. Main objective of this platform, emulating the implantable platform capability by the integration of the CircuLite pump and implanted flow and pressure sensors, is the demonstration of the ARU capability. In ICT area, the main achievements are represented by the fully functional second prototype of the monitoring applications and communication modules between PMA and SMA (Specialist Monitoring Application) by covering the full range of functional requirements with the sole exception of the communication between ARU and PMA, due to the ongoing ARU development and wearable platform integration. For the second prototype, PMA was fully integrated with SMA at server side and vice versa, while communication between the applications is supported by the relevant communication components. The SensorART database schema has been updated. It needs to be populated. Another main reached goal has been the delivery of the First Prototype of the integrated VAD-Heart Simulation and Specialist's Decision Support platform (MS15). For achieving the Milestone, technical partners have collaborated with research/clinical partners into the fine-tuning of the design of the respective modules as well as the corresponding development following a JAD (joint application development) approach. A dedicated focus activity has been applied to develop "Local training method" and "Remote training method" modules (according to training application architecture) together with a "Learning Management System". An intensive work towards integration has been addressed in order to achieve a close loop system through the communication of PMA and SMA applications, as a "bridge" between the patient and the specialist. Along with the development activities, it was also further enhanced and expanded the System Architecture Document with the contributions from almost all partners. This document is the base of all the development being done from this point onwards as it contains all the integration points among the various components. In the experimental laboratories, relevant results are obtained by standardizing protocols, acquiring and monitoring recipient-device interactions, in vivo testing of flow sensor in housed in the CircuLite pump in different experimental animal models, tuning and testing hybrid and numerical simulators. The numerical simulator has been also preliminary utilized at HONIG before VAD implantations of heart failure patients, by anticipating the time schedule of clinical use and activity.