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THE NEW COMBINATION APPLIANCE FOR SLEEP APNEA Welcome to the .rtf

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THE NEW COMBINATION APPLIANCE FOR SLEEP APNEA  Welcome to the .rtf Powered By Docstoc
					THE CAUSE OF OBSTRUCTIVE SLEEP APNEA (OSA)
Humans are unique because their upper airway has a curved shape, an anatomical change that is related to the
evolution of human speech and upright posture. As a result, the upper airway of humans is more flexible than
other species and is more prone to collapse under negative pressure. When awake, a tonus in the upper airway
muscles prevents this collapse. However during sleep muscle tonus decreases, and the tongue can drop
backward into the throat and plug the airway. The inability to breathe continues until it triggers an adrenalin
release which causes a gasp that temporarily restores the airway.

EFFECTS OF OSA
Although a single airway blockage event rarely causes full awakening, the frequent microarousals and
adrenalin releases significantly interfere with sleep. In addition, the sporadic nocturnal loss of oxygen and
increase in carbon dioxide probably causes a number of other negative consequences to health. Some of the
known effects include hypertension, stroke, myocardial infarction, and premature death.


MEDICAL TREATMENT
Medical treatment for OSA is currently inadequate. Medications, head and neck extension collars, weight loss,
abstaining from tobacco and alcohol, and sleep position modification have only minor benefits. The standard
medical treatment is the Continuous Positive Airway Pressure (CPAP) machine, - an air pump coupled with a
mask that is strapped tightly over the face during sleep. CPAP works well as long as the pressure is high
enough and the mask fits tightly enough to keep the airway ballooned out. However most patients hate it.
Nearly half of those who are given a CPAP machine do not use it regularly.

Surgeries which have been used to treat OSA include procedures to advance the mandible (bilateral
osteotomies), remove soft tissues from the soft palate and pharynx (UPPP), remove a portion of the
hypopharynx by radiofrequency application (TCRF), prevent the hyoid from dropping back (hyoid myotomy
or hyoideppiglotoplasty), insert a stiffener into the soft palate (the pillar procedure), and reduce the tongue
volume (laser midline glossectomy, and lingualplasty). None of these procedures has been able to treat OSA
with predictable success.

DENTAL TREATMENT
Dental treatment for OSA is also currently inadequate. Dentists use at least 60 different oral appliances to
elevate the soft palate, depress the rear of the tongue, hold the tongue in protrusion, or hold the lower jawbone
in protrusion. Treatment with these appliances is generally more tolerable than CPAP. However, until now,
treatment with oral appliances has also been much less effective than CPAP.

JAW PROTRUSION APPLIANCES
The vast majority of oral appliances used by dentists to treat OSA work by protruding the lower jawbone.
Since the lower jawbone surrounds the airway on the front and both sides, appliances which bring the lower
jawbone forward increase the available space for airway in the throat. However, a recent ten year review
found that their maximum success rate was rarely more than about 50% reduction in AHI for about 50% of the
subjects. The reason for this limited effectiveness of jaw protrusion appliances is that they still can’t prevent
the tongue from dropping back and plugging the throat – the tongue just has a little further to go.

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THE TONGUE RESTRAINING DEVICE (TRD)
1982 saw the introduction of a tongue retaining device (TRD), a molded silicone monobloc which contains a
bulb that can be squeezed to create suction which grips the front of the tongue and holds it out between the
lips. Studies showed that the TRD was difficult for many patients to tolerate. Studies also showed that, while
the TRD was somewhat more effective than jaw protrusion appliances in those who were able to wear it, it still
didn’t cure everybody. The TRD holds only the front portion of the tongue forward, so the rear of the tongue
can still contact the soft palate and block the airway there.

TONGUE REAR DEPRESSION
Recently an appliance called the Full Breath Solution (FBS) appliance has shown significant success in
treatment of sleep apnea by holding down the back of the tongue with a smooth plastic extension of a dental
appliance. However, because the plastic extension which holds down the back of the tongue is rigidly
attached to the dental appliance, it is difficult to adjust correctly.

A NOVEL TONGUE HOLDING DEVICE (THD)
We developed a novel tongue holding device which grasps the whole body of the tongue and holds it down
and forward against the lower jawbone by “pinning” it between upper and lower tongue gripping surfaces,
each comprised of thousands of miniature forward-slanted points resembling directional Velcro. The upper
tongue gripping surface contains 4,000 points sized to fit between the filiform papillae which populate the top
surface of the tongue. The lower tongue gripping surface contains 11,000 points designed to grip the mucous
membrane on the underside of the tongue like a bed of nails. These tongue gripping surfaces are so effective
that connecting them with even a light compressive force creates sufficient grip to hold the tongue in a
protrusive position all night long without causing any evidence of inflammation or injury. The THD is made
of dental acrylic so it can be attached to almost any type of dental appliance, and the compressive force is
provided by orthodontic elastics, which are available in a variety of sizes and strengths.

COMBINING TONGUE PROTRUSION WITH JAW PROTRUSION
Protruding the tongue and the lower jawbone are best accomplished together, because the tongue and the
lower jawbone are intimately attached. The tongue has no bone of its own, so the lower jawbone forms its base
of operation. For that reason, our combination appliance combines tongue protrusion and lower jawbone
protrusion as shown in the illustration below.




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COMBINING TONGUE AND JAW PROTRUSION WITH TONGUE REAR DEPRESSION
There are also good reasons for combining jaw and tongue protrusion with depression of the rear portion of
the tongue. Having the tongue in a protrusive position makes it easier to access and hold down the rear of the
tongue, and holding down the rear of the tongue pushes the rest of the tongue forward into the grip of the
THD. In addition, the THD is the ideal oral appliance for holding down the rear portion of the tongue,
because its upper tongue gripping surface already extends to the rear of the tongue. Adding an extension
creates a resilient source of tongue rear depression, so it doesn’t need to be adjusted perfectly to provide
adequate therapeutic effect without traumatizing the tissues there.

THE COMBINATION APPLIANCE
By combining tongue and jaw protrusion with tongue rear depression, the combination appliance is the first
oral appliance to treat sleep apnea by protecting the entire upper airway. Studies have shown that most
patients with sleep apnea have more than one site of narrowing in their upper airway. For that reason, the
previous oral appliances which only addressed one area of the upper airway sometimes work and sometimes
don’t work. Furthermore, even if they work now, they may fail to work in the future as the tissues continue to
loosen with age and lead to blockage in the unprotected areas of the upper airway.




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