Patent Publication Number: US-2005133026-A1

Title: Device for the treatment of snoring and obstructive sleep apnea

Description:
BACKGROUND OF THE INVENTION  
      1. Technical Field  
      The present invention is the universal unmedicamental system to treat the snore and obstructive sleep apnea and to lead to the recovery of normal breathing during sleep.  
      2. Background Art  
      In the time of normal breathing, the air passes in the throat through the flexible structures (the soft palate, uvula, tonsils, and tongue) easily, without noise. While awake, muscles around each structure tighten to hold the structure in place so it doesn&#39;t block the air&#39;s passage. During sleep, these muscles relax, but the passage to the throat still stays clear enough for air to flow freely into and out of the lungs.  
      During sleep, some people have greater relaxation of structures&#39; muscles and as a result occurs the considerable loss of their elasticity. The tongue shortens and thickens, its protruding root sticks in the throat, and together with the uvula, soft and hard palates blockade the way of the air&#39;s passing. The passage of the air from a nose or mouth through this blocked canal causes the throat&#39;s vibration and the appearance of the snoring sound. If the tongue is sticking inside the throat, the soft palate&#39;s structures are pressed with the tongue to the throat&#39;s back wall, causing the complete blockade of the air&#39;s passing into the lungs. This condition is called sleep apnea.  
      Snore and sleep apnea happen to men and women of different ages. But with its increase, the quantity of people suffering from this deficiency is growing. At first, there is a small block of air and the sleep snore is short. Little by little, the disease develops, the block of air grows, and sleep snoring becomes loud and irritating to the surroundings, interchanging with frequent obstructive sleep apnea.  
      Although a person doesn&#39;t hear his or her own snore, it causes harm to his health. Snore and sleep apnea disturb the breath and cause the hipoxia of the brain, and do the sleep uneasiness and irregularity. After the uneasy night, a person awakes with a headache, irritability, and sleeplessness, which may cause the person to possible fall asleep behind a car&#39;s wheel. Disturbing dreams are accompanied with stress, which lead to increased blood pressure, and possible heart attack and/or stroke.  
      At the present time, for the treatment of snoring and sleep apnea, there are devices used which push forward the lower jaw, but they do not give due effect. The appliance Continuous Positive Airway Pressure (CPAP) has significant shortcomings too, and they restrict its employment. The main shortcoming of CPAP is the uninterrupted blow under pressure with the generator the air&#39;s flow through the nose into the lungs. This causes the soft palate&#39;s undesirable putting down in the throat to the tongue&#39;s pharyngeal part, the difficulty of the exhalation, and is the contraindication for people with existing respiratory failure, decompensated cardiac failure, diseases of the nose, ear, etc. CPAP is bulky, works from the electrical transmission network, does not function when the patient&#39;s mouth is open, and prevents a person to sleep. The price of CPAP and tests before its prescription are often beyond the means for people. All this causes the necessity in new inventions to treat the snore and the obstructive sleep apnea.  
      The purpose for the present invention is the treatment of the snore and obstructive sleep apnea for sick persons of any age, regardless of their diseases and without any influence on the physiological act of the breath during the inhalation and the exhalation; the rendering with the appliance of the medical effect without any additional factors of the influence; the simplicity and the compactness of the device, enabling to use it in any person&#39;s living conditions; the absence of contraindications for its employment; the recommendation of it without any special tests.  
      This aim was realized by the expulsion of the tongue—the main object between the obstructive structures of the throat—from the process of the obstruction of the air&#39;s passing through the throat. Tongue&#39;s moving forward from the mouth, with the fixation of the tongue with the aid of the proposed device is new in the decision of practical task of the treatment of snore and the obstructive sleep apnea. In the time of the tongue&#39;s moving in the front position, its pharyngeal part shirts in the mouth. The throat&#39;s cavity extends, and it gets impossible for the obstruction of the air&#39;s passing into the lungs and in the opposite direction. Moving forward of the tongue in the front part of the mouth in the time of sleep does not disturb the physiological breath of both types (through the nose and the mouth), regardless of a person&#39;s age and attendant diseases.  
     SUMMARY OF THE INVENTION  
      The present invention is a universal system to treat the sleep snore and the obstructive sleep apnea, and thanks to this provide normal breathing during sleep. Since the tongue plays the decisive role in the obstruction for air&#39;s passing through the throat, just the tongue is chosen for the decision of practical task of the removal of this obstruction. With this purpose, the tongue is moved forward and fixed with a special device. One end of this fixation is fastened through an aperture in the oral part of the tongue on the level of a front third of the tongue&#39;s bridle and the second end is fastened to the device, put against the chin. The device is fixed from above with the wedge-shaped ledges, which are put on the side teeth of the lower jaw, from below with the semicircular strip situated outside from the lower jaw, and from the sides with strips covering the person&#39;s cheeks. The final fixation of the device is realized with the strip being put on the head. The wedge-shaped ledges put on each side of the teeth of the lower jaw also protect the tongue from the bite of the teeth of the upper jaw.  
      The device put on the lower jaw doesn&#39;t prevent-the opening and closing of the mouth. The tongue&#39;s front part jutting out the bound of the anterior teeth and the fixation of the tongue are covered with the device&#39;s lid.  
      In the time of the tongue&#39;s moving forward, its pharyngeal part advances from the throat in the mouth and as a result the throat&#39;s cavity increases, and becomes free for the air&#39;s passage. Thanks to an absence of the tongue&#39;s pharyngeal part in the throat, other structures become incapable to provoke an obstruction of the air&#39;s passing, and as a result, the inhalation and the exhalation become almost noiseless.  
      The device&#39;s design and way to use are simple and haven&#39;t any unfavorable influence or risk upon a person&#39;s health. Therefore, before the using, it is not required to perform any special tests in a sleep clinic; there is enough of a doctor&#39;s examination and recommendation.  
      Before sleep, the chin body of the device is put to the chin and fixed with straps. Then the tongue sticks out and into the small aperture on its end there is inserted the fixation&#39;s hooked front part. The fixation&#39;s other end fastens to the device&#39;s chin body, after this the tongue with the fixation is covered with a lid, and the lips close spontaneously the mouth.  
      When the device is installed, the breath remains physiological, the inhalation and exhalation free as with nasal type of the breath as with mouth type. During the nasal type of breath, the tongue&#39;s fixation doesn&#39;t prevent the closing of the mouth. In the case of some nose diseases (polypuses, partition&#39;s curvature, cold, etc.), which make difficulty for the breathing through the nose, the sick person can breathe with the open mouth or use for the full compensation simultaneously both types of breath.  
      The fastened to the chin device and the tongue&#39;s partial moving out the bound of the anterior teeth doesn&#39;t prevent to change the body&#39;s position and swallow during the sleep. The device is portable, doesn&#39;t present any difficulties in the time of its transportation, and can be used at any conditions of a person&#39;s life. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       FIG. 1  is the sagittal section through the nose, mouth and throat. The position of the structures in the throat with the tongue&#39;s moving forward from the mouth, and the air&#39;s flow in the time of nasal breath.  
       FIG. 2  is the sagittal section through the nose, mouth and throat. The position of the structures in the throat with the tongue&#39;s moving forward from the mouth, and the air&#39;s flow in the time of the simultaneous nasal and through the mouth breathing.  
       FIG. 3  is the sagittal section through the nose, mouth and throat. The position of the tongue and the structures in the throat in the time of the partly blocked air&#39;s flow during the snore.  
       FIG. 4  is the sagittal section through the nose, mouth and throat. The position of the tongue and the structures in the throat in the time of the completely blocked air&#39;s flow during the sleep apnea.  
       FIG. 5  is the sagittal section through the nose, mouth and throat. The position of the tongue, structures in the throat, and the free air&#39;s flow in the time of the nasal breathing during the normal sleep.  
       FIG. 6  is the sagittal section through the nose, mouth and throat. The position of the tongue, structures in the throat, and the free air&#39;s flow in the time of the simultaneous nasal and through the mouth breathing during the normal sleep.  
       FIG. 7  is the general view of the device.  
       FIG. 8  is the exterior view from the side and from above of the chin body.  
       FIG. 9  is the exterior view from the side and from below of the chin body.  
       FIG. 10  is the exterior view of the strip under the lower jaw.  
       FIG. 11  is the exterior view of the lid.  
       FIG. 12  is the exterior view of the head strap.  
       FIG. 13  is the exterior view of the tongue&#39;s fixation.  
       FIG. 14  is the exterior view of the position of the hole in the tongue and the fixation: A—view from above, B—view from below.  
       FIG. 15  is the sagittal section through the nose, mouth, throat, and the device fastened to the chin and head, and the free air&#39;s flow during the sleep.  
       FIG. 16  is the general view of the device fastened to the chin and head. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
      As is shown in the drawings, the present invention  20  to treat the snore and the sleep apnea includes the tongue  21  as the main obstructive structure of the throat  22  in the time of the passing of the air&#39;s flow  23  through the throat in the lungs ( FIG. 1, 15 ). Thanks to the fixation of the tongue  21  after its moving in the front position, the tongue&#39;s pharyngeal part  24  shifts into the mouth  25 , and the tongue excludes from the obstructive process. This deprives in its turn the soft palate&#39;s  26  structures and the uvula  27  of the possibility to provoke the partial ( FIG. 3 ) or the complete ( FIG. 4 ) obstruction of the air&#39;s passing through the throat into the lungs.  
       FIG. 3  and  FIG. 4  illustrate that in the sleeping time, when the muscles of the soft palate  26  and the tongue  21  relax more normal, they cause the obstruction to the air&#39;s passing through the throat. Besides the tongue is main participant in this process. In comparison with normal ( FIG. 5 ), the tongue becomes shorter and thicker, its oral part  28  draws away from the front teeth  29  inside the mouth  25 , its pharyngeal part  24  thickens and moves into the throat  22 , presses the soft palate&#39;s structures  26  to the throat&#39;s back side  30 , and as a result occurs the complete obstruction of air&#39;s passing through the throat, and then comes the sleep apnea ( FIG. 4 ).  
      Therefore, to decide a practical task of the treatment of the snore and the obstructive sleep apnea, the present invention regards as the main object of the research the tongue. It remains fixed during sleep in the pushed forward from the mouth position ( FIG. 1, 15 ). In this tongue&#39;s position ( FIG. 1  in the time of the nasal breath, and  FIG. 2  during the simultaneous nasal and through the mouth breathing), air&#39;s flow  23  goes like during the normal breath ( FIG. 5, 6 ), that is to say free pass by structures of the nose  31  and the mouth  25  (the hard palate  32 , the tongue  21 ), and then pass by structures of the soft palate  26 , the uvula  27 , the tonsils  33  through the trachea and the bronchia into the lungs and back.  
      In the time of the tongue&#39;s moving forward position ( FIG. 1, 15 ) in comparison with the norm ( FIG. 5 ), the tongue&#39;s pharyngeal part  24  shifts from the throat  22  into the mouth  25 . Thanks to this, the throat extends in the time of sleep, the tongue excludes from the link of the throat&#39;s obstructive structures, occurs the rupture in the obstructive mechanism ( FIG. 3, 4 ).  
      The present invention includes its exterior part ( FIG. 7 ), which consists from the device&#39;s chin body  34 , the fixation  35  of the tongue ( FIG. 13 ), and the head strap  36  ( FIG. 12 ). The chin body has from above two wedge-shaped ledges  37  ( FIG. 8 ), the recess with U-shaped configuration  41  for the tongue  21  ( FIG. 7, 8 ), the hollow  38  for a chin  39  and lower lip  40  ( FIG. 15 ), and the rectangular aperture  42  ( FIG. 9 ) for inserting of the plug  43  to fasten the mobile strip  44  under the lower jaw  54  ( FIG. 10 ). On sides to the chin body, there are two strips  45  adjoining to people&#39;s cheeks with hinges  46  ( FIG. 7, 16 ), and the lid  47  from above ( FIG. 7, 11 ), fastened to the chin body with compressing plugs  57 . To the hinges  46  on the strips  45  and  44  adjoining correspondingly to the cheeks and to the lower jaw, is fastened to the head strap  36  ( FIG. 12, 16 ). The tongue&#39;s fixation  35  ( FIG. 13 ) is the concave strip with hooked ends. The end inserting into the small hole  49  in the tongue has the mobile tip  48 .  
      The most effective and reliable for the fixation is the hole  49 , made in the oral part  28  of the tongue ( FIG. 14 A, 14  B) on its frenulum&#39;s end  50  in the distance of the deep lingual artery  51 , deep lingual vein  52 , and lingual nerve  53 .  
      The wedge-shaped ledges  37  ( FIG. 15 ) settle down on the lower side of the teeth  29 . They keep the device&#39;s chin body from above and protect the tongue from the bite with teeth. The strip  44  is adjusted tightly under the lower jaw  54  and fastens to the chin body  34 , keeping it from below. The tongue  21  moves forward in the hollow  41 . From above of the tongue is situated the fixation  35 . With one end it grasps the tongue through its hole  49 , and with the other end fastens the tongue to the chin body  34  through its aperture  55 . A lid  47  covers the tongue from above and preserves it from the dryness during the sleep. The chin body is fixed from the right and left with strips  45  adjoining to the cheeks of a sick person ( FIG. 16 ).  
      The device&#39;s situation on the chin  39  doesn&#39;t restrict a person&#39;s living conditions, and possibilities to change a body&#39;s position during sleep. The breathing and the swallowing are not disturbed. A person can breathe through the nose and through the mouth or both types of breathing simultaneously.  
      The installation of the device proceeds as follows ( FIG. 15, 16 ). The chin body  34  is put on the chin  39  so that the wedge-shaped ledges  37  sit down on the lower side teeth  29  (in case of their absence—on the gums), and the strip  44  under the lower jaw  54 . After this, the strap  36  is put on the head over the ears, and one pair of bridles  56  are fastened to the hinges  46  on the strips  45  adjoining to the cheeks, another pair—to the hinges on the strip  44  under the jaw, and are put on the head in front of the ears. Then, on the moved forward tongue through the hole  49 , the fixation  35  is inserted, and the other fixation&#39;s end fastens with the chin body. After this, the tongue and the fixation shield with the device&#39;s lid  47 .  
      An examination of the device on the person suffering from noisy sleep snore and obstructive sleep apnea was demonstrated with the positive result of the treatment. The device didn&#39;t prevent to a process of the people&#39;s sleep, and didn&#39;t make any inconvenience in the time of changing of the body&#39;s positions. The breathing was kept even, noiseless, and the sleep was deep and quiet.