Abstract:
A nasal respiratory device combined with a neuromuscular stimulator adapted to provide electrical stimulation intraorally and/or intranasally to a patient for improving breathing and treating a respiratory disorder.

Description:
TECHNICAL FIELD 
       [0001]    The devices and methods described herein relate generally to the field of medicine and more particularly to the fields of sleep and pulmonary medicine being useful for the treatment of diseases of air flow including snoring, sleep apnea and other breathing disorders. 
       BACKGROUND 
       [0002]    The mechanism of collapse of the airway that occurs during some stages of sleep is due to a general relaxation of the muscles that stabilize the upper airway segment. Snoring, in general, is the vibration of relaxed respiratory structures. The obstructive sleep apnea (OSA) syndrome afflicts 3% of the general population and is due to episodic upper airway obstruction during sleep. Invasive treatments of OSA includes such surgical interventions as tracheostomy, uvalopalatopharyngoplasty, and maxillo-facial reconstruction. Therapy with medicine has, in general, been unproductive. The current non-invasive standard for treatment of breathing disorders is Continuous Positive Airway Pressure (CPAP) either performed nasally and/or intraorally: for example, U.S. Pat. No. 4,249,527 to Ko and U.S. Pat. No. 4,944,310 to Sullivan demonstrate methods and devices for CPAP. Mask discomfort, nasal congestion, nasal dryness, eye irritation, leakage of air through the mouth or nose (CPAP requires the maintenance of pressure) are very common problems for patients new to CPAP and other high pressure systems. CPAP has very poor patient compliance. 
         [0003]    The prior art also includes devices containing electrodes for treating respiratory conditions. There are two methods in which electromuscular stimulation can be applied to a patient; invasively or non-invasively. Invasive electrical stimulation of a muscle involves implanting one or more electrodes, either permanently or temporarily within the patient. Non-invasive electrical stimulation of the muscles in the upper airway involves placing an electrode in direct contact with a surface of the patient and passing a current through the surface tissues adjacent the electrode: for example, U.S. Pat. No. 4,830,008 to Meer exhibits electrical stimulation to nerves and U.S. Pat. No. 5,284,161 issued to Karell exhibits a device for increasing muscle tone with electrodes applied to the soft palate in a removable dental appliance. Airway patency depends on the activity of the pharyngeal dilator muscles. Common sites of obstruction are behind the tongue and at the level of the soft palate; hence, the reason for electrical stimulation to the soft palate to increase muscle tone. The muscles of the tongue, especially the posterior fibers of the genioglossus, draw the base of the tongue forward and anteriorly. One or more of the muscles of the tongue and/or mouth and/or pharynx and/or larynx normally contract reflexively during inspiration. OSA sufferers experience reduced muscle tone during sleep as compared to non-OSA patients, thereby causing a reduction in airway patency. Stimulation of one or more of the above structures improves airway dilatation. Airways that would normally collapse during respiration remain open when the patient breathes through pursed-lips, which is helpful in chronic obstructive pulmonary disease (COPD) and other respiratory conditions. Pursing lips produces expiratory resistance via proximal obstruction, that is, (Positive Expiratory End Pressure, PEEP). Pursing lip therapy is commonly used in daily medical practice. What is missing in the prior art is the combination use of electrical stimulation and nasal or oral respiratory methods and devices. A combination effect is beneficial. The prior art does include U.S. Pat. No. 5,792,067 to Karell that contains electrodes and an airway; however, the Karell patent lacks the ability to include the nasal cavity; it also lacks the ability to include resistance in air passageways. 
       BRIEF SUMMARY 
       [0004]    Described herein are respiratory devices and methods for treating a variety of medical diseases through the combined use of intraoral and/or intranasal electrodes for increasing muscle tone, stimulating muscles and nerves, and respiratory devices including devices making use of resistance in air passageway orally or nasally. CPAP and other high pressure systems are also utilized. Resistive respiratory devices may be added to either or both the nasal passageway or the oral passageway. Some versions of these devices make use of expiratory resistance to mimic the effects of pursed-lip breathing with or without PEEP. 
         [0005]    The respiratory methods and devices described herein are adapted to be removably secured in communication with a respiratory cavity. A respiratory cavity may be a nasal cavity (e.g., nostril or nasal passage) or an oral cavity (e.g., mouth or throat). The respiratory device comprises a nasal passageway, and a intraoral holdfast for removably securing the respiratory device in communication with the respiratory cavity. The holdfast contains one or more electrodes for contacting an intraoral and/or intranasal surface. Additionally, an airflow resistor in communication with the nasal passageway or intraoral airway may be added. 
         [0006]    In one version of the instant invention, the respiratory method and device is in communication with a nasal cavity and the device is removably secured in place with an intraoral holdfast. The holdfast may be adapted to be secured to the upper or to the lower dentition of a user&#39;s mouth. A stimulator within the holdfast is connected to an electrode for contacting an intraoral and/or an intranasal surface. Any or all of the components of the device may be moldable for user comfort. 
         [0007]    In another version of the instant invention, the respiratory method and device is in communication with a nasal cavity and the device is removably secured in place with an intraoral holdfast. The holdfast is composed of two components; an upper dentition member and a lower dentition member, wherein the members may be positioned to improve airway patency. A stimulator within the holdfast is connected to an electrode for contacting an intraoral and/or an intranasal surface. Any or all of the components of the device may be moldable for user comfort. 
         [0008]    In another version of the instant invention, the respiratory method and device is in communication with a nasal cavity and the device is removably secured in place with an intraoral holdfast. The holdfast is additionally comprises a tongue holding means for holding the tongue in a position to increase airway patency. A stimulator within the holdfast is connected to an electrode for contacting an intraoral and/or an intranasal surface. Any or all of the components of the device may be moldable for user comfort. 
         [0009]    Any or all versions may have an intraoral holdfast that includes an airway. 
         [0010]    Any or all versions may have an intraoral holdfast that includes of tongue holding means for pulling the tongue anteriorly thereby increasing patency in the respiratory tract. 
         [0011]    Additionally, any or all versions may include an airflow resistance means. The airflow resistance may be orally and/or nasally performed. Virtually any type of airflow resistor may be used with the respiratory devices described herein, including flap valves, membrane valves, hingeless valves, balloon valves, stopper-type valves, ball valves, and the like. Airflow resistance may be one-way or two-way and may be controllable. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]      FIG. 1  is a perspective view of a nasal respiratory device with an intraoral holdfast having a stimulator and an intraoral electrode. 
           [0013]      FIG. 1A  is a perspective view of a nasal respiratory device with an intraoral holdfast having a stimulator and an intranasal electrode. 
           [0014]      FIG. 2  is a perspective view of a respiratory device with an intraoral holdfast additionally having an airway. 
           [0015]      FIG. 3  is a perspective view of a nasal passageway and/or an intraoral airway additionally having an airflow resister. 
           [0016]      FIG. 4  is a perspective view of a respiratory device having a holdfast with two members which are adjustable in relation to each other. 
           [0017]      FIG. 5  is a perspective view of a respiratory device having a holdfast capable of holding the user&#39;s tongue in a position to improve respiratory tract patency. 
       
    
    
     DETAILED DESCRIPTION 
       [0018]    Referring to  FIGS. 1-1A  there is shown therein a general representation of the instant invention ( 10 ) of a respiratory nasal device combined with an intraoral stimulator for providing intraoral or intranasal stimulation to a user to reduce or minimize the occurrence of a breathing disorder. Referring to  FIG. 1  a nasal passageway ( 12 ) is connected ( 13 ) to a holdfast ( 14 ) adapted to be inserted into a user&#39;s mouth thereby securing the nasal passageway ( 12 ). The holdfast ( 14 ) is depicted as fitting over an upper dentition. The holdfast contains a stimulator ( 16 ) which is attached to at least one electrode ( 18 ), which is shown in  FIG. 1  as intraorally placed electrode whereas in  FIG. 1A  the electrode ( 18 ) is shown as intranasally placed electrode. The user inserts nasal passageway ( 12 ) into his (or hers) nostril(s) and inserts the holdfast ( 10 ) in his (or hers) mouth. The intraoral holdfast removably secures the nasal passageway. The stimulator ( 16 ) is activated and energizes the electrode ( 18 ) which is in contact with an intraoral (or intranasal) surface. The energized electrode stimulates muscles or nerves to enhance respiratory patency. Additionally, the nasal passageway may be connected to CPAP. (not shown) 
         [0019]    Referring to  FIG. 2  shows the holdfast ( 14 ) additionally having an airway ( 20 ). CPAP may also be utilized via the airway. (not shown) 
         [0020]    Referring to  FIG. 3  shows the nasal passageway ( 12 ) and the airway ( 20 ) having airflow resistors ( 26 ). The airflow resistor has similar clinical effects as does pursing lip therapy in treating respiratory disorders such as COPD. The airflow resistor may be one or many. The airflow resistor may be in the nasal passageway and/or the holdfast. The addition of airflow resistor decreases the pressure required when CPAP is utilized. 
         [0021]    Referring to  FIG. 4  shows a holdfast comprising two components: an upper dentition member ( 32 ) and a lower dentition member ( 34 ) operably connected by a connecting assembly ( 36 ). Generally speaking, a user will position the lower member to protrude relative to the upper member thereby enhancing the respiratory space. 
         [0022]    Referring to  FIG. 5  shows a holdfast additionally having a tongue holding means ( 50 ) in which the user&#39;s tongue is pulled forward to enhance the respiratory space. The above detailed description illustrates the invention by way of example, not by way of limitation of the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention. The following are examples of prior art which may be useful in the understanding of the utility of the instant invention. 
         [0023]    U.S. Pat. No. RE36120 to Karell entitled “SNOPPER—THE SNORING STOPPER ANTI-SNORING MOUTH DEVICE” is described and the entire disclosure of which is incorporated herein by reference. 
         [0024]    U.S. Pat. No. 5,792,067 to Karell entitled “APPARATUS AND METHOD FOR MITIGATING SLEEP AND OTHER DISORDERS THROUGH ELECTROMUSCULAR STIMULATION” is described and the entire disclosure of which is incorporated herein by reference. 
         [0025]    U.S. Pat. No. 6,212,435 to Lattner et al. entitled “INTRAORAL ELECTROMUSCULAR STIMULATION DEVICE AND METHOD” is described and the entire disclosure of which is incorporated herein by reference. 
         [0026]    U.S. Pat. No. 6,618,627 to Lattner et al. entitled “INTRAORAL ELECTROMUSCULAR STIMULATION DEVICE AND METHOD” is described and the entire disclosure of which is incorporated herein by reference. 
         [0027]    U.S. Pat. No. 6,209,542 to Thornton entitled “COMBINATION FACE MASK AND DENTAL DEVICE FOR IMPROVED BREATHING DURING SLEEP” is described and the entire disclosure of which is incorporated herein by reference. 
         [0028]    International Patent Application PCT/US2005/044888 by Doshi et al. entitled “RESPIRATORY DEVICES AND METHODS OF USE” is described and the entire disclosure of which is incorporated herein by reference.