Abstract
The interest in the design of portable and wearable medical devices is related to both the relevant clinical and social benefits for patients and the potential economic savings for national health services. The development of such biomedical devices can help people live in a more comfortable way and allow for the execution of therapies, that are usually performed in hospitals, at home. This article presents a new wearable and portable mechatronic device for extracorporeal blood ultrafiltration, named RAP, able to remove excess fluids from overhydrated patients with chronic kidney disease and/or congestive heart failure. An innovative layout paradigm has been introduced for the RAP, involving a box-like design that can fit a backpack or a trolley, ensuring miniaturization and ergonomics, and an original-effective positioning of the components. These have been divided on three independent planar panels: One for disposable devices, one for non-disposable components and one for electronic boards and controllers. This solution guarantees the best trade-off between miniaturization and ergonomics and can drastically simplify and speed up the in-hospital operations needed before and after a therapy with the RAP. The design of an effective, efficient, safe and reliable control architecture, based on two microcontrollers and one microcomputer, has been carried out too, being essential features of the RAP. Currently, the RAP is ready for clinical tests which will include a phase-1 trial in humans after Ethical Committee approval.