Abstract:
The intraoral mandibular advancing positive pressure apparatus utilizes mandibular advancement (or protrusion) therapy with CPAP therapy. The mandibular advancement appliance is fabricated to receive a portion of a person&#39;s upper and lower teeth when the patient bites down on the appliance. The mandibular advancement appliance advances the patient&#39;s mandible a predetermined amount. The mandibular advancement appliance contains a fluid communication pathway that provides for access to the patient&#39;s oral cavity. A CPAP device is in fluid communication with the fluid communication pathway and supplies a continuous positive pressure air supply. The utilization of mandibular advancement therapy with CPAP therapy reduces the amount of advancement necessary through mandibular advancement and eliminates the need for nasal involvement or a facial mask typically associated with CPAP therapy.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. provisional application Ser. No. 61/800,330 filed Mar. 15, 2013 entitled Intraoral Mandibular Advancing Positive Pressure Device, which is incorporated by reference herein. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable. 
       BACKGROUND 
       [0003]    1. Field. 
         [0004]    The present apparatus and method relate to the treatment of obstructive sleep apnea (“OSA”). 
         [0005]    2. Description of the Related Art. 
         [0006]    OSA is a common disorder with some estimates ranging from 12 to 18 million people in the United States needing treatment. Others estimate that if the general public were studied in a sleep lab by polysomnography (formal “sleep study”), that approximately 1 in 5 American adults would have at least mild OSA. A S Shamsuzzaman, B J Gersh &amp; V K Somers,  Obstructive sleep apnea: implications for cardiac and vascular disease,  290 J. Am. Med. Ass&#39;n. 1906-14 (2003). The most serious and deadly consequences of OSA are the cardiovascular diseases that can arise. Hypertension, tachycardia, increased risk of cerebrovascular accidents, daytime hypercapnia, atrial fibrillation, and even coronary artery disease all have been associated with OSA. Y Sharabi, Y Dagan &amp; E Grossman,  Sleep apnea as a risk factor for hypertension,  13 Current Opinion in Nephrology and Hypertension 359-64 (2004). 
         [0007]    The general aim in treating sleep-breathing disorders is to facilitate breathing by increasing the airway passages. Different surgical and non-surgical treatments for OSA have emerged due to the varied causes of OSA. Treatments all focus on preventing collapse of the lumen of the pharynx during sleep. 
         [0008]    Surgical treatment is generally reserved for patients with severe OSA or those that do not tolerate non-surgical treatments. One of the more common surgical treatments is orthognathic surgery where a patient&#39;s mandible, and/or maxilla, is moved forward. Moving the mandible forward causes the tongue and pharyngeal dilator muscles, and indirectly the soft palate, to move forward opening or expanding the oropharyngeal airways. Surgery is disfavored due to the aggressiveness of the surgery and the lengthy recovery time, often requiring the patient to adhere to an all liquid diet for six weeks. 
         [0009]    Home use of a CPAP device is generally regarded as the gold standard for initial treatment of OSA. R Zozula &amp; R Rosen,  Compliance with continuous positive airway pressure therapy: Assessing and improving treatment outcomes,  7 Current Opinion in Pulmonary Med. 391-98, 2001. Treatment using a CPAP device has shown to be very effective in most OSA patients regardless of where the obstruction in the pharynx occurs. In this treatment method, the patient wears a mask at night that generally encompasses the mouth and nose. A machine continuously forces air through a hose that is connected to the mask. The forced air keeps the pharynx unobstructed, due solely to the increased air pressure, similar to as if it were being blown up like a balloon. The amount of air necessary to keep the pharynx unobstructed varies based on the patient and severity of the OSA, as a result, the CPAP machine may be regulated to determine the proper amount of forced air necessary. However, many patients have poor long term compliance because of the amount of pressure that is required as a sole source of oral pharyngeal patency. 
         [0010]    While treatment through a CPAP device has been shown to be highly effective, there exist several negative aspects that reduce compliance. The most important aspect is that many patients simply cannot tolerate the treatment. Many complain of not being able to sleep with a mask on their face or that it feels unnatural to have air blown down their throat for extended times at a high air pressure. Other reasons for discontinuing CPAP therapy have been primarily related to issues of nasal dryness and congestion and difficulty adapting to the high pressure. Other patients have more cosmetic complaints such as not wanting to wear the mask that is generally secured through an elastic band against the back of the head, skin irritation on the face from the mask, and the discomfort of feeling excess heat against the patient&#39;s face due to the mask. Research shows poor long term compliance of this treatment modality. 
         [0011]    For patients with mild-to-moderate OSA who cannot tolerate CPAP treatment, and where orthognathic surgery is a too aggressive treatment, mandibular advancement through a removable oral appliance is a suitable alternative. The mandibular advancement device (“MAD”) resembles orthognathic surgery in that the device advances the mandible forward increasing the oropharyngeal airway. G T Clark, D Arand, E Chung, et al.,  Effect of anterior mandibular positioning on obstructive sleep apnea,  147 Am. Rev. Respiratory Disease 624-29, 1993. Patients undergo a trial and error phase of treatment to determine the correct amount of advancement that provides the most OSA treatment. J A Haskell, J McCrillis, B Haskell, et al.,  Effects of Mandibular Advancement Device (MAD) on Airway Dimensions Assessed with Cone-Beam Computed Tomography,  13 Seminars in Orthodontics 132-38, 2009. Generally, most patients need mandibular advancement equivalent to seventy-five percent of the patient&#39;s maximum advancement. This amount of advancement is generally effective for eighty percent of patients. 
         [0012]    Use of an MAD avoids many of the drawbacks associated with CPAP treatment but creates a different set of problems. Many patients that require the jaw to be advanced further than typical comfort level, and those at the seventy-five percent advancement threshold, develop musculoskeletal discomfort and temporomandibular joint (“TMJ”) discomfort. This is due to the extreme advancement required to have the desired lumen obstruction of the pharynx to achieve satisfactory OSA treatment. Other patients may see their teeth changing positions, including formation of gaps or overcrowding, that may interfere with the patient&#39;s normal or regular bite. This may ruin previous orthodontia alignment or cause a patient to need additional orthodontia. 
       BRIEF SUMMARY 
       [0013]    The intraoral mandibular advancing positive pressure apparatus and method utilizes a CPAP therapy with mandibular advancement therapy to treat OSA The apparatus comprises an intra-oral appliance fabricated to correspond to a patient&#39;s maxillary and mandibular teeth. The appliance is custom fabricated to protrude the patient&#39;s mandible a predetermined amount. The appliance is in fluid communication with a CPAP device. The fluid communication path allows air to access the oral cavity of the patient from the CPAP device. The appliance virtually seals the oral cavity to prevent leaking of air between a patient&#39;s teeth and cheeks as well as to prevent leaking of the positive pressure air outside the patient&#39;s oral cavity. A bi-directional valve with at least one vent is located along the fluid communication path between the CPAP and the appliance. The bi-directional valve and at least one vent allow the patient&#39;s expiratory air, should it travel though the oral cavity of the patient, to escape the system. The bi-directional valve is readily available on the open market place and commonly found on current CPAP Devices. 
         [0014]    The method for treating OSA includes the steps of advancing a patient&#39;s mandible a predetermined amount and supplying continuous positive air pressure to the patient&#39;s oral cavity. One method of achieving mandible advancement involves fabrication of an intra-oral appliance that causes mandibular advancement when the appliance is inserted into a patient&#39;s mouth. The amount of mandibular advancement is generally less than seventy five percent of the maximum mandibular advancement of a specific patient. The appliance is inserted into the mouth of the patient with the patient biting down onto the appliance. A portion of the patient&#39;s upper and lower teeth match the impressions of the appliance and retain the appliance within the patient&#39;s mouth. When the appliance is inserted, the patient&#39;s mandible is protruded by the predetermined amount. The appliance is in fluid communication with a CPAP device wherein the CPAP device supplies a steady flow of positive air into the oral cavity of the patient. As the patient exhales through the oral cavity, the expiratory air exits the intraoral mandibular advancing positive pressure apparatus through the bi-directional valve and vents. 
         [0015]    The utilization of mandibular advancement therapy in conjunction with CPAP therapy results in effective treatment of OSA without many of the negative side effects each therapy holds. The supply of continuous positive air pressure to a mandibular advancement appliance generally allows for less mandibular advancement. This apparatus allows for less than seventy-five percent of mandibular advancement and generally requires only forty to fifty percent of the patient&#39;s maximum mandibular advancement. The patient experiences more comfort with less mandibular advancement and is less likely to develop TMJ, teeth realignment, and/or changes to a patient&#39;s bite. Due to advancement of the mandible resulting in alleviating some obstruction of the pharynx, less air pressure from the CPAP device is generally necessary to accomplish the clinical goal of treating OSA. Further, the sealing effect of the appliance allows for the elimination of the nasal component of standard CPAP interfaces, eliminates the need for a mask, eliminates the need for a restraint of a mask, reduces the amount of physical items in contact with the patient&#39;s face, and eliminates the common discomfort felt by typical CPAP patients. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0016]      FIG. 1  illustrates an angled top view of an embodiment of an intraoral mandibular advancing positive pressure appliance. 
           [0017]      FIG. 2  is a partial cross-section view of an embodiment of an intraoral mandibular advancing positive pressure appliance. 
           [0018]      FIG. 3  is a side profile view of an embodiment of an intraoral mandibular advancing positive pressure appliance engaged with a person&#39;s maxilla and mandible. 
           [0019]      FIG. 4  is a front view of an embodiment of an intraoral mandibular advancing positive pressure appliance engaged with a person&#39;s maxilla and mandible. 
           [0020]      FIG. 5  is a close up view of an embodiment of an intraoral mandibular advancing positive pressure apparatus in use by a person. 
           [0021]      FIG. 6  is a view of an embodiment of an intraoral mandibular advancing positive pressure apparatus in use by a person. 
       
    
    
     DETAILED DESCRIPTION 
       [0022]      FIGS. 1 and 2  disclose the intraoral mandibular advancing positive pressure appliance  10  comprising a mouthpiece  20  and breathing tube connector  30 . The mouthpiece  20  comprises a maxillary portion  21 , mandibular portion  23 , sealing portion  25 , and molding support  28 . Maxillary portion  21  is generally shaped in the form of an arch and contains impressions of a portion of a patient&#39;s upper teeth  22 . Mandibular portion  23  is generally shaped in the form of an arch and contains impressions of a portion of a patient&#39;s lower teeth  24  (as seen in  FIG. 3 ). Molding support  28  is generally arch shaped contains openings  29  and is positioned between maxillary portion  21  and mandibular portion  23 . Sealing portion  25  connects maxillary portion  21  and mandibular portion  23  through the openings  29  of the molding support  28 . Sealing portion  25  connects maxillary portion  21  and mandibular portion  23  to create a seal between maxillary portion  21  and mandibular portion  23 . The maxillary portion  21 , mandibular portion  23 , and sealing portion  25  are generally constructed of a pliable material such as polymethyl methacrylate (PMMA). Molding support  28  is more rigid than maxillary portion  21 , mandibular portion  23 , and sealing portion  25  and is generally constructed of copolyester. The position of the maxillary portion  21  relative to the mandibular portion  23  is predetermined based on the desired mandibular advancement for the patient. 
         [0023]    Breathing tube connector  30  is generally oval shaped having a sidewall  31 , exterior sidewall surface  32 , interior sidewall surface  33 , intraoral opening  34 , and extra oral opening  35 . Breathing tube connector  30  is fused to the molding support  28 . Breathing tube connector  30  is positioned within in the sealing portion  25  proximal to the apex of the arch shaped sealing portion  25  between the maxillary portion  21  and mandibular portion  23 , specifically between the impressions of the upper anterior teeth  26  and the lower anterior teeth  27  (as seen in  FIG. 4 ). Breathing tube connector  30  extends away from the curve of the sealing portion  25 . The position of breathing tube connector  30  within the sealing portion  25  creates a fluid communication pathway into the interior space  11  of mouthpiece  20 . 
         [0024]    As seen in  FIG. 3 , sidewall  31  further comprises a tapered portion  37 . The tapered portion  37  consists of exterior sidewall surface  32  and interior sidewall surface  33  narrowing from the widest formation located proximal to the extra oral opening  35  to the narrowest portion located approximately in the middle of breathing tube connector  30 . Ridge  36  is located proximal to extra oral opening  35  and circumscribes sidewall  31 . Breathing tube connector  30  angles negatively, greater than zero degrees but less than ninety degrees, in relation to the center longitudinal axis of the intraoral opening  34 . 
         [0025]    Referring to  FIGS. 3 and 4 , a patient&#39;s upper teeth  40 , as part of maxilla  41 , correspond to the maxillary impressions  22  of maxillary portion  21 . The patient&#39;s lower teeth  42 , as part of the mandible  43 , correspond to the mandibular impressions  24  of the mandibular portion  23 . When the patient bites down on the mouthpiece  20 , the patient&#39;s mandible and maxilla are held in place by the teeth in the respective impressions. The fixed position of the mandibular portion  23  causes the patient&#39;s mandible  43  to protrude relative to the maxilla  41  in the direction of arrow  44 . 
         [0026]    Referring to  FIGS. 5 and 6 , the mouthpiece  20  of the appliance  10  is located within the mouth of the patient. The patient&#39;s lips  45  rest on the tapered portion  37  of the breathing tube connector  30 . The patient&#39;s upper teeth are engaged to the impressions of the maxillary portion and the lower teeth are engaged to the impressions of the mandibular portion. When a patient&#39;s teeth are engaged in the impressions, the fluid communication pathway created by the breathing tube connector is the only access into the oral cavity. The mouthpiece forms a virtual air tight seal keeping air from leaking between the maxillary portion  21  and mandibular portion  23 . 
         [0027]    Elbow connector  50  is a generally hollow tube having a sidewall  51 , breathing tube connection opening  52 , and a breathing hose connection opening  53 . The elbow connector  50  has a straight portion  54  and an angled portion  55 . The straight portion terminates at the breathing tube connection opening  52  and the angled portion  55  terminates at the breathing hose connection opening  53 . The straight portion  54  and angled portion  55  meet at an approximate ninety degree angle resulting in the breathing hose connection opening  53  being oriented ninety degrees from the breathing tube connection opening  52 . The breathing tube connection opening  52  is frictionally engaged to the exterior sidewall surface  32  of the breathing tube connector  30 . Ridge  36  provides an abutment point for the elbow connector  50 . A bi directional valve  56  is located within the angled portion  55 . One or more air evacuation holes  57  are dispersed around the elbow connector  50  proximal to the bi-directional valve  56  and placed between the breathing tube connector  30  and the bi-directional valve  56 . Hose  58  is frictionally engaged to the breathing hose connection opening  53 . The hose  58  is connected to a standard CPAP device  59 . Hose  58  is generally constructed of flexible material. Elbow connector  50  is generally constructed of light weight but rigid material. In another embodiment, the elbow connector  50  may contain a swivel joint allowing the elbow connector  50  to rotate around the exterior sidewall surface  32  of the breathing tube connector  30 . 
         [0028]    Fabrication of the appliance starts with the creation of impressions from a patient&#39;s maxillary and mandibular arches utilizing standard industry techniques. Using a George Gauge, or similar device, a patient&#39;s range of mandibular advancement is measured. For this treatment methodology, the amount of mandibular advancement for the patient is calculated at seventy-five percent or less of the patient&#39;s maximum mandibular advancement. 
         [0029]    Stone models are created from the patient&#39;s impressions. The maxillary portion  21  and mandibular portion  23  are created from the stone models using industry standard techniques. The stone models are mounted to a dental articulator where the predetermined mandibular advancement is transferred to the dental articulator. The fabricated maxillary portion  21  and mandibular portion  23  are placed on the stone models with the mandibular stone model appropriately protruded. The vertical dimension of the occlusion is opened allowing insertion of the molded support  28  with the fused breathing tube connector  30  between the maxillary portion  21  and mandibular portion  23 . Sealing portion  25  is created through PMMA resin which secures the maxillary portion  21  and mandibular portion  23  to the molded support  28 . Openings  29  in the molded support  28  allow PMMA resin to create solid bond between molded support  28 , maxillary portion  21 , and mandibular portion  23  through sealing portion  25 . 
         [0030]    The method of treatment using the appliance  10  is disclosed in reference to  FIGS. 3 ,  5 , and  6 . The mouthpiece  20  is inserted into the patient&#39;s mouth such that the patient bites or clamps down on the mouthpiece  20 . The patient&#39;s upper teeth  40  engage the maxillary portion  21  and the patient&#39;s lower teeth  42  engage the mandibular portion  23 . When the patient bites down, the patient&#39;s mandible  43  protrudes forward a predetermined amount based on the desired prescription. 
         [0031]    The patient&#39;s lips  45  rest on the tapered portion  37  of the breathing tube connector  30 . The breathing tube connection opening  52  of the elbow connector  50  is connected to the breathing tube connector  30  of appliance  10 . The angle of the breathing tube connector  30  provides a more comfortable fit for the patient by reducing the weight applied to the appliance  10  and held in place by the patient&#39;s bite. The hose  58  connects to the breathing hose connection opening  53  on one end and connects to the CPAP device  59  on the other. A fluid communication pathway is created from the CPAP device  59  to the patient&#39;s oral cavity. Advancing the lower mandible increases the airway space by bringing the structures that make up the lumen of the oropharynx forward. 
         [0032]    The CPAP device  59  is activated and set to a predetermined pressure setting. The CPAP device  59  forces air through the machine to the oral cavity of the patient through the fluid communication pathway comprising the hose  58 , elbow connector  50 , and appliance  10 . The patient&#39;s natural bite keeps the appliance  10  in place. The sealing portion  25  of the appliance  10  and the patient&#39;s lips resting on the tapered sidewall  37  virtually seal the oral cavity to prevent escape of the positive pressure air and reduce the amount of positive air existing between the patient&#39;s teeth and cheeks. As the patient exhales, the expiratory air leaves the oral cavity, through the intra oral opening  34 , into the connector tub  30 , out the extra-oral opening  35  and to the elbow connector  56 . The bi-directional valve  56  causes the expiratory air to exit the fluid communication path through the air evacuation holes  57 . The positive pressure air keeps the pharynx unobstructed. The use of the appliance  10  reduces the amount of air necessary from the CPAP device  59  and makes it unnecessary to utilize a full face mask or require the blockage of nasal passages. 
         [0033]    The present disclosure is described above in terms of a preferred illustrative embodiment of a specifically-described Intraoral Mandibular Advancing Positive Pressure Appliance. Those skilled in the art will recognize that alternative constructions of such an appliance may be used. Other aspects, features, and advantages may be obtained from a study of this disclosure and the drawings, along with the appended claims