A Novel Device for the Treatment of Obstructive Sleep Apnea

Abstract

In this thesis, a novel device for the treatment of Obstructive Sleep Apnea (OSA) is developed and tested. This device uses intra-oral suction to stabilize tongue and/or soft palate in a position that does not obstruct the airway, thus reduce apnea episodes. The treatment device consists of a patient-specific oral device and a non-patient-specific pump unit. Patients wear the oral device on their upper palate that directs suction towards tongue and/or soft palate. A length of tubing connects the oral device to the pump unit, which is placed bedside and is envisioned to be a wearable device in further iterations.

Experimental results from a small-scale clinical trial verified that the device performs its intended function of stabilizing the tongue, and does not cause increase in Apnea Hypopnea Index (AHI) in healthy volunteers. MRI Imaging on volunteers wearing the device proved the device does enlarge the airway by 60% - 80%. A finite element model of the tongue, soft palate and airway, with muscle fiber direction derived from Diffusion Tensor MRI, is implemented as a proof of concept that the device can treat OSA. The estimation of the level of vacuum required to stabilize the tongue by a finite element (FE) model is consistent with experimental results.