Polymeric Orthosis with Electromagnetic Stimulator Controlled by Mobile Application for Bone Fracture Healing: Evaluation of Design Concepts for Medical Use.

Background: The occurrence of bone fractures is increasing worldwide, mainly due to the health problems that follow the aging population. The use of additive manufacturing and electrical stimulators can be applied for bioactive achievements in bone healing. However, such technologies are difficult to be transferred to medical practice. This work aims to develop an orthosis with a combined magnetic field (CFM) electrostimulator that demonstrates concepts and design aspects that facilitate its use in a real scenario. Methods: A 3D-printed orthosis made of two meshes was manufactured using PLA for outer mechanical stabilization mesh and TPU for inner fixation mesh to avoid mobilization. A CFM stimulator of reduced dimension controlled by a mobile application was coupled onto the orthosis. The design concepts were evaluated by health professionals and their resistance to chemical agents commonly used in daily activities were tested. Their thermal, chemical and electrical properties were also characterized. Results: No degradation was observed after exposure to chemical agents. The CMF achieved proper intensity (20-40 µT). The thermal analysis indicated its appropriate use for being modelled during clinical assessment. Conclusion : An orthosis with a coupled electrostimulator that works with a combined magnetic field and is controlled by mobile application was developed, and it has advantageous characteristics when compared to traditional techniques for application in real medical environments.