Field of invention

The invention generally relates to the treatment of snoring and obstructive sleep apnea (OSA).

Background

Snoring and OSA are serious illnesses with a high prevalence and an increasing incidence.

OSA is a sleep disorder in which a person stops breathing periodically throughout the night due to physical obstructions of the airway. These stops in breathing usually last for approximately ten seconds and are often followed by snorts, gasps, or choking sounds as a person's body fights to resume breathing again. When you sleep, the muscles in your body relax so they can begin to repair themselves to keep you healthy and active every day. However, muscles in your mouth and throat also relax during sleep, and for some people (an estimated 18-20 million U.S. adults) these muscles along with soft fatty tissues relax to the point where they fall back into the upper airway and block the flow of oxygen from coming in. When you stop breathing during the night, your brain responds by partially waking to send signals to the respiratory system to work harder to get past the obstruction.

Side effects of OSA include:

• high blood pressure

• heart arrhythmias

• heart disease

• heart attack

• stroke

• increased risk of diabetes

• depression/cognition problems • fatigue

• and even death

How severe one's sleep apnea is can be determined by the amount of apnea events (pauses in breathing):

• Mild OSA- The sufferer experiences 5-14 episodes of interruptions in breathing in an hour.

• Moderate OSA- The sufferer experiences 15-30 episodes of interruptions in breathing in an hour.

• Severe OSA- The sufferer experiences 30 or more interruptions in breathing in an hour.

Several solutions have been proposed for their treatment. One of the most promising is the use of a Mandibular Advancement Device (MAD). The following publication provides an overview of this approach:

“Mandibular advancement device for obstructive sleep apnea: An overview"

S. Raghavendra Jayesh and Wasim Manzoor Bhat ; J Pharm Bioallied Sci. 2015 Apr; 7(Suppl 1): S223-S225

A MAD manages the cross-sectional diameter of the oropharynx so as to eliminate snoring and may even cure OSA. Most MADs are titratable, i.e. they comprise two separate tight- fitting trays covering all the teeth and that are connected by a mechanical arm, gear or screw. These trays can be difficult to seat and remove. This type of design puts force on all the teeth, ligaments and alveolar bone thus causing discomfort after wearing the MAD overnight.

There are numerous inventions on how to connect the upper and lower trays. There is strong focus for a MAD that can adjust the amount of forward advancement of the lower jaw which opens the airway and to allow for side to side motion for better temporomandibular joint (TMJ) health.

General description of the invention

An objective of the present invention is to provide an improved appliance for the treatment of snoring and OSA.

To this effect the invention concerns an appliance for the treatment of snoring and obstructive sleep apnea comprising a non-titratable MAD that is made of at least two opposite elastic bite pads and a bar, the pads being connected with the bar.

In one embodiment of the invention the bar is a palatal bar.

In another embodiment of the invention the bar is a lingual bar.

The appliance according to the invention is unique due to the fact that it is not a fixed tooth tray appliance but rather a free-floating passive appliance minimizing forces to the teeth and alveolar bone. It is more comfortable to wear, less bulky reducing drooling, more durable with less breakage, more hygienic and easier to clean, no gingival irritation or increased risk or caries and is less costly without titrating mechanisms. It provides greater comfort due to its sleek design and maintains an open-air passage by preventing the tongue from blocking the windpipe during sleep. Most prior art MADs are made of two separate tight-fitting trays covering all the teeth connected by a mechanical arm, gear or screw. These trays can be difficult to seat in the mouth and remove. This type of design puts force on all the teeth and their ligaments thus causing discomfort after wearing the MAD overnight. In addition, traditional MADs have the unwanted“headgear effect” due to the mechanism being attached to upper and lower trays. In essence when the mandible is pushed forward an equal and opposite effect pushes the maxilla backward which is contraindicated. With the appliance according to the invention, the forces are directed to the capsular matrix and not to the teeth or alveolar process. Therefore, there is no force directly on the teeth and PDL which is the case for tooth tray MADs often being painful to wear. The appliance according to the invention does away with trays connected with mechanical arms, gears or screws. As mentioned previously, it is made of two simple bite pads, preferably made of silicone, with a palatal or a lingual bar connecting the two pads. The advantages of the lingual bar instead of the palatal bar is to make more room for the tongue and to allow the tongue to rest against the top front part of the palate as it should. Preferably, a vestibular bow helps to keep the appliance attached to the upper jaw and increases the effectiveness of the lower lingual flanges which ultimately guide the lower jaw to the predetermined therapeutic position. In addition, a few or several ball or delta clasps can be added to the upper or lower occlusal planes. This option can be incorporated if the practitioner and patient wish that both jaws stay firmly attached to the appliance. Normally this one component loose fitting device is designed so as the patient wearing it naturally wants to bite down as the lingual flanges easily guide the lower jaw into the desired position to open the airway. The pads allow for adequate three-dimensional movement to the TMJ preventing it from being frozen in one place. The device is preferably fabricated only after the correct position of the mandible has been determined clinically. This is clearly better than having the patient or dentist use guess work when adjusting the MAD. In addition, with a preferably carefully chosen amount of elasticity of the silicone, freedom of the TMJ can be obtained without ridged 2D mechanical devices, preventing natural movements to the most delicate and complex joint in the human body.

According to Newton’s laws of motion, to every action there is always opposed an equal and opposite reaction.

When using a MAD, the maxilla is retracted and tipped down in time. Sleep Disorder Breathing and Obstructive Sleep Apnea patients have a deficient maxilla in varying degrees to start with. Adjustable and titratable appliances use force to push the mandible forward which then pushes the maxilla backwards. This unsolicited movement of the maxilla is making SDB and OSA worse.

The non-titratable appliance according to the invention is using the Bionator effect to advance the mandible. It therefore has no negative side effects on the maxilla. Detailed description of the invention

The invention will be better understood in the present chapter, with two non-limiting examples illustrated by the following figures:

Figure 1 : 1 ^st example of an appliance according to the invention, with a palatal bar . Gray scale picture of the frontal aspect allowing to show the details of silicone pads.

Figure 2: Other view of the 1 ^st example. Gray scale picture of an oblique view showing precise detail and shape of the pads.

Figure 3: Fontal drawing

Figure 4: Oblique drawing

Figure 5: Lateral drawing of appliance seated in the mouth

Figure 6: Bite registration

Figure 7: Anatomical drawing of mouth breathing versus nose breathing

Figure 8: Drawing demonstrating snoring

Figure 9: Drawing demonstrating OSA

Figure 10: Drawing demonstrating correctional effects of a MAD

Figure 11 : 2nd example of an appliance according to the invention, with a lingual bar .

Gray scale picture of the frontal aspect allowing to show the details of silicone pads.

Figure 12: Other view of the 2nd example. Gray scale picture of an oblique view showing precise detail and shape of the pads.

ABBREVIATIONS:

MAD: mandibular advancement device

OSA: obstructive sleep apnea

TMJ: temporomandibular joint

CBCT: cone beam computerized tomography

CPAP: continuous positive airway pressure

PDL : periodontal ligament

Numerical references used in the figures : 1. Bite pads

2. Palatal bar

3. Lingual bar

4. Vestibular bow

5. Omega loop

6. Upper occlusal plane

7. Lower occlusal plane

8. Ball clasp

9. MAD

The device shown in the illustrated examples is made up of two silicone pads using e.g. 70-80 shore silicone. The vestibular arc is preferably made of round stainless steel, for instance 0.8mm in diameter. The omega loops can be tightened to help retain the appliance in a seated position. The palatal or lingual bar which connects the two silicone pads is advantageously made of stainless-steel bar, for instance 3mm wide and 1.5mm thick. Mechanical retentive modifications of the palatal or lingual bar are made to enable the silicone to adhere to the stainless steel. This type of MAD is designed based on the Bionator appliance; a free-floating device. When the patient inserts the device in the mouth, the mandible is forced in a protrusive position. The response of the muscles of mastication acting on the mandible is an attempt to return it to its initial position of rest, but the silicone extensions lingual to the mandibular teeth tend to hold the mandible in this protrusive position. Due to the two lingual extensions, the jaws normal reaction is to close. As a result, the appliance positions the jaw in the desired anterior posterior position. The bite registration is what determines the amount of protrusion. The bite registration is obtained when the patient is directed to bite into a piece of softened wax in the protrusive position. The wax bite is then placed on the plaster models ultimately placing the models in the ideal relationship to one another. After that the laboratory technician can begin to fabricate the appliance. Various methods such as acoustic reflection, pulse oximetry, CBCT technology and sleep induced endoscopy are used to help obtain a therapeutic bite registration. Another such method is airway metrics, used to identify a target treatment position and comfortable starting position for the bite registration. It uses a patient’s subjective feedback to achieve the best snore sound reduction position. These methods are accurate ways to determine therapeutic positions of the mandible before the appliance is made thus eliminating the need for adjustment mechanics incorporated into the typical MAD. Thus, the ideal position is determined before the appliance is fabricated eliminating the need to rely on patients guess work trying to find this ideal position. The mechanical effect of the appliance is directed to the capsular matrix and not to the teeth or alveolar process. Therefore, there is no force directly on the teeth and PDL which is the case for tooth tray MADs.

Different options of the appliance are available and can be ordered from the assigned laboratory by the practitioner depending on the patients existing dental conditions. All patients present with different dental conditions. Teeth can be missing or compromised in the four different quadrants. If compromised or missing teeth exist in any of these quadrants the dentist can choose the best option for the patient. Retention of the appliance can be obtained from the vestibular bow if anterior teeth are intact and posterior teeth are compromised. Alternatively, upper and or lower ball clasps can be used if anterior teeth are unstable. In essence any combination of stainless-steel retentive components can be used depending on the patient needs and preferences.

Due to the advancements of 3D printing and digital dental scanners, STL files of the patient’s dentition can be sent to any laboratory in the world who has this technology so as to mass produce the appliance. If the practitioner or patient opt for the 100 percent silicone version of the appliance, then the bar would be made slightly thicker and wider as well as it resting on the lingual surface of the lower incisors and gingiva. Fabrication of the appliance all in silicone is best achieve by injecting 70 to 80 shore silicone into a flask at 5-6 bars of pressure. Patients can choose from any of the colors available. Various versions of the appliance components can be used.

- stainless-steel vestibular bow

- stainless-steel ball clasps on the upper

- stainless-steel ball clasps on the lower

- stainless-steel ball clasps on the upper and lower

- stainless-steel combination of ball clasps and vestibular bow

- all components in silicone, i.e. no stainless steel

The bar would be necessary in all cases. If the bar is made of silicone instead of stainless steel then it would be wider . In such a case a lingual bar would rest behind the lower incisors.

As mentioned previously, the invention is not limited to the illustrated examples.