Computational modeling

A computational model of the soft palate was created to analyze the stiffening effect of the implants. This model was used to study the influence of implant design, placement, and size on soft palate stiffness. The goal of the analysis was to assess implant stiffening effect, given the assumptions and limitations of a model of the soft palate. The model generated the following key observation:

The greater the number of implants placed in the soft palate, the greater is the stiffening effect, and the greatest stiffening effect will occur when the implants are spaced closely about the midline.

Pharyngeal closing pressure is a well established physiological outcome measurement in which a more negative value implies a less collapsible airway (i.e. less pressure is required to collapse the pharynx in an apneic patient).¹ A finite element analysis (FEA) model of the upper airway developed at The Harvard Medical School was used to examine the effect of palatal implants on pharyngeal closing pressure.² The results of the analysis are summarized below:

E is Young’s modulus, a measure of material stiffness.

The FEA demonstrates that under three diverse conditions, relative stiffening of soft palate tissue increases the pressure necessary for closure to occur. The FEA demonstrates that the addition of palatal implants is shown to be more effective than scar tissue alone.

The magnitude of effect is similar to what has been reported in literature suggesting that the observed findings are clinically significant.² Changes in palatal stiffness using implants have important effects on pharyngeal biomechanics. The order of magnitude of the effect is in the range that would certainly be clinically significant.

1. A. Malhotra et al. "Upper Airway Collapsibility: Measurement and Sleep Effects," Chest 2001;120:156-161Read More
2. A. Malhotra et al. "The Male Predisposition to Pharyngeal Collapse: The Importance of Airway Length," Am J Res Crit Care Med 2002;166:1388-1395 Read More

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).