Snoring and obstructive sleep apnea are part of sleep disordered breathing (SDB) continuum. Beginning with mild snoring, this continuum progresses to obstructive sleep apnea in those most severely afflicted. SDB can result in sleep deprivation leading to daytime sleepiness, posing a risk for work place accidents, especially for those operating heavy machinery or motor vehicles. The long-term consequences of sleep-disordered breathing consist of an increased risk of high blood pressure, heart disease, and stroke. Current treatments to reduce snoring can be very painful and remain effective for only a short period of time before follow-up treatment is required. Pi Medical proposes a simple, relatively painless, placement of an implant to stiffen the soft palate, thereby, eliminating the vibrations known as snoring. The implantable device overcomes the disadvantages of current treatments by placing a permanent implant into the soft palate using a very simple procedure. The potential to use the implants to treat obstructive sleep apnea syndrome (OSAS) also exists. OSAS is characterized by intermittent closure of the pharyngeal airway during sleep resulting in episodes of hypoxemia and sleep disruption. Currently there are no treatments aimed specifically to treat the collapse of the pharyngeal walls. An effective treatment would be aimed at reducing the compliance of the pharyngeal walls; this would reduce their ability to collapse and alleviate upper airway obstruction without interfering with normal functions. The purpose of this research is to evaluate methods to maximize tissue ingrowth and fibrotic response to the implants with the expectation that this will increase the total stiffening effect of the implant and result in an implant that provides adequate properties to alter the compliance of the airway structures to 1) positively effect snoring levels or 2) prevent pharyngeal wall collapse associated with obstructive sleep apnea without affecting the normal function of the pharyngeal walls.
