DyNeuMo Mk-1: A Fully-Implantable, Motion-Adaptive Neurostimulator with Configurable Response Algorithms
AbstractThere is growing interest in using adaptive neuro-modulation to provide a more personalized therapy experience that might improve patient outcomes. This paper describes the design of the ‘DyNeuMo Mk-1’, a fully-implantable, motion-adaptive research stimulator that titrates stimulation based on the patient’s movement state (e.g. posture, activity, shock, free-fall). The design leverages off-the-shelf consumer technology that provides inertial sensing with low-power, high reliability and modest cost. We used a three-axis accelerometer and its embedded digital motion processor to enable real-time stimulation adaption based on configurable motion parameters. The algorithm configurability and expanded stimulation parameter space allows for a number of applications to be explored in both central and peripheral applications. The implantable system was designed, prototyped and verified using ISO 13485 design controls, including ISO 14971 risk management techniques to ensure patient safety, while enabling novel algorithms. With the design controls in place, first-in-human research trials are now being prepared to explore the utility of automated motion-adaptive algorithms. The design highlights how consumer electronics technology can be leveraged for efficient and reliable medical device development. The implantable system automatically provides activity- and posture-based responsive stimulation which can be configured by the clinician to optimize therapy. Intended applications include adaptive stimulation for movement disorders, synchronizing stimulation with circadian patterns, and reacting to transient inertial events such as shocks for urinary incontinence.