ImThera’s implant is for those with obstructive sleep apnea (OSA) who have failed to find successful benefit from other treatments.

OSA is a very serious condition. With each obstruction sleep is interrupted and patients do not get a good night’s rest and awake in the morning sleepy, almost as if they haven’t slept at all. In addition each obstruction causes a rise in blood pressure. Normally the blood pressure decreases at night and when it is constantly raised, the arteries harden and hypertension develops. People who do not sleep well have serious changes in the hormones that modulate hunger, hence they eat more and they gain weight. Weight gain makes OSA worse. Furthermore with each obstruction the brain is deprived of oxygen and inflammatory mediators are adversely affected, these in turn increase development of vascular, cardiac and neurologic disease. This combined with the increased blood pressure result in early development of angina, heart attack, stroke and diabetes. While it is difficult to reverse some of these changes, it is important to stop their progression. It has been observed that people with OSA don’t feel well, are prone to accidents, do poorly at work, have marital problems, have medical problems prematurely and generally die earlier than they would have were it not for the OSA.

It is understood that the problem with most OSA patients is that during sleep the tongue falls backwards into the throat and obstructs normal nighttime breathing.

THN Sleep Therapy stimulates the nerve that provides motor innervations to tongue muscles. During sleep most muscles relax. This is true of the tongue muscles as well. By providing gentle stimulation to the hypoglossal nerve, normal daytime tongue muscle tone is restored to key muscles and the tongue does not fall into the throat, the airway is kept open and the patient can once again breathe normally during sleep.

The THN Sleep Therapy implant surgery is relatively simple. An incision is made in the upper neck. The hypoglossal nerve is readily identified medial to the digastric muscle and the electrode is placed around the nerve. The electrode is connected to a small pulse generator (IPG) implanted in the upper chest wall. Potential implantation complications are few, primarily infection, estimated to be 1%.

The system can be programmed a couple of weeks after implantation. It stimulates the hypoglossal nerve and returns daytime muscle tone to the sleeping tongue and prevents it from falling back in the throat and obstructing the upper airway. The implant is recharged through the skin two or three times a week. It is turned on by the patient with a handheld radio-frequency device prior to sleeping. It then runs throughout sleep, and is turned off in the morning. Not requiring additional sensors or synchronization. The THN Sleep Therapy stimulator can be reprogrammed by the physician as often as required.

It is designed to help OSA patients who cannot comply with other therapies and to work for OSA caused by the tongue. It is the physicians responsibility to determine those patients whose obstruction is tongue based.