Aerodynamic airflow

A sophisticated computational model was utilized to evaluate the effect of an implant on airway flow and is illustrated below. Although the model is somewhat simplified, all of the major features of the human anatomy are represented, as described below.

Bench Model Schematic

The model consists of four walls that form a channel, replicating the human upper airway. The channel is attached to a vacuum system that draws air into the model, simulating inhalation by the lungs. A partition is placed between the upper and lower walls of the channel, replicating the hard palate and dividing the incoming airflow between “nose” and “mouth” inlets. The vertical position of both the upper and lower walls is adjustable, allowing the simulation of varying levels of airway obstruction. The soft palate, which is attached to the hard palate and channel side walls by way of a clamp, consists of a layer of flexible silicone. The angle of the soft palate relative to the incoming airflow can be varied to simulate the range of soft palate orientations that may occur with different sleep positions. When the vacuum system is activated, air is drawn into the model through the “nose” and “mouth” inlets. The walls of the channel are clear so that the motion of the soft palate during a simulated snore can be visualized. At a critical air velocity, the silicone soft palate oscillates much like that of a human soft palate during snoring.

Experiments were performed to investigate soft palate support and stiffening strategies using various iterations of a wind tunnel model. Tape was used to represent a stiffening effect without increasing the mass to the point of unrealistically dominating the structure. The experiments showed that stiffening the soft palate in a “front-to-back” fashion significantly increased the air velocity needed to initiate palatal oscillation and reduced the magnitude of the movement.

Increasing airspeed causes the palate to vibrate in a wave motion Motion begins near the hard and soft palate junction Motion transmitted from hard palate towards uvula

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Stiffening uvula end does not reduce palate motion Greatest aerodynamic "lift" is experienced at the hard and soft palate junction where vibration is initiated

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Stiffening the soft palate closer to the hard palate junction reduces vibration by: Affecting the region with the greatest aerodynamic lift Preventing the onset of the vibrating motion

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The Pillar® System is indicated for use in a) the reduction of symptomatic, habitual or social snoring caused by a flutter of tissue in the soft palate, and/or b) upper airway obstruction in patients with mild to moderate Obstructive Sleep Apnea or "OSA". The Pillar System is a minimally invasive implant that is used to stiffen the soft palate tissue to reduce the flutter that causes snoring and/or palatal obstruction of the upper airway.

Physicians interested in the Instructions for Use (IFU).