Three different designs for implantable regenerative autonomic interfaces have been produced, based on thin film technology, microchannels, and microwires. Biocompatible polymers electrospinned Neural Guidance Conduits have been produced in 3 different inner diameters, ready for testing. Further biocompatible materials and process methods are being tested for advanced Neural Guidance Conduits, as well as neural regeneration-compliant hydrogel fillers.
Implantable electronics and packaging solutions to control NeuHeart hardware are being developed by: (i)Preliminary design and tapeout of a modular 16-channel stimulator in CMOS technology; (ii) Implantable sensor readout reviews; (iii) Preliminary system level design of an implantable readout system.
A non-mechanical stiffness sensor has been developed through (i) Literature review of electrical impedance spectroscopy (EIS) towards heart stiffens monitoring; (ii) EIS system development; (iii) Preliminary design of an integrated version of the new EIS method.
Five conceptual approaches for heart activity sensors have been developed, with three approaches for epicardial implantation, and two concepts designed for implantation into the ventricular wall.
The EM modeling effort for the first year focused on (i) establishing the required technologies for modelling EM-neuron interactions in detailed, microscopy- and histology-based multifascicular nerve models, (ii) construction and exploration of initial models of vagus nerve stimulation, and (iii) performing first sensitivity analysis and uncertainty quantification work. In addition, theoretical ground work towards (iv) stimulation optimization and (v) validation has been performed.
A baseline model that reproduces cardiac dynamics in heart-failure patients was developed which forms the foundation for modelling hemodynamic changes and impairment of autonomic control in early heart transplant recipients.The baseline model was modified and extended to simulate hemodynamic changes and impairment of autonomic cardiac control that can be observed in early heart transplant recipients.The result is an integrated model, composed of the cardiovascular system, intrinsic heart rate control and autonomic regulation.
Activities aimed at full mapping of the VN, led to the establishment and implementation of a multimodal imaging pipeline combining classical histology techniques with anti-Stokes Raman scattering (CARS), optical coherence tomography (OCT), contrast enhanced micro-CT (μCT) and high-resolution episcopic microscopy (HREM). A bank of biological samples has been fully established from 4 different models.
We reviewed the most relevant literature and the prominent legislation to identify and analyse the ethical and legal issues of potential relevance for the project.In particular, attention has been devoted to ethical concerns, legal constraints and applicable regimes, regulatory gaps, economic barriers and implications for healthcare systems and barriers/business opportunities for the European medical devices industry. Research has been conducted to identify the Cardiovascular devices and Global heart transplant market and stakeholders at the EU/extra EU level to strategically target the dissemination and communication activities.
