This article presents a novel solution aimed at addressing complications in hemodialysis patients. Hemodialysis requires an arteriovenous fistula (AVF) to facilitate the high blood flow necessary for effective dialysis. However, the continuous high flow through the AVF, even outside dialysis sessions, often leads to complications such as occlusion, thrombosis, aneurysms, and increased cardiac load.
This study introduces an innovative, fully implantable device that enables non-invasive control of the AVF flow using a magnetic drive mechanism. The prototype features a magnetic ring system that allows external coupling and torque transmission, thereby manipulating an AVF valve non-invasively. This mechanism is designed to removing the continuous high flow normalize the circulation when dialysis is not being performed, while still allowing sufficient high flow during dialysis. This will potentially minimize the complications associated with AVFs.
Extensive testing was conducted through implantation in arm and sheep cadavers to evaluate the sizes, locations, transmission torque, output force, and valve closure through different skin thicknesses. The results demonstrated that the device could achieve a maximum output force of 78.9±4.2 N, 46.7±1.9 N, 25.6±0.7 N, 13.5±0.6 N and 6.3±0.4 N could be achieved non-invasively through skin thicknesses of 1-5 mm respectively, ensuring effective valve closure under various conditions. The prototype successfully met the design requirements, showing promise for in vivo applications.
The significance of this research lies in its potential to transform the management of vascular access in hemodialysis patients. By enabling non-invasive control of AVF flow, this technology could significantly reduce the risk of complications, improve patient outcomes, and lower healthcare costs associated with reinterventions and long-term management of AVFs. The next steps involve in vivo studies to further assess the functionality and systemic effects of this promising technology.