Patent Publication Number: US-2022226590-A1

Title: Cross reference to related applications

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This is a continuation of U.S. patent application Ser. No. 15/472,051, filed Mar. 28, 2017, now pending, and this application claims the benefit of U.S. Provisional Patent Application Ser. No. 62/314,678, filed Mar. 29, 2016, which is incorporated by reference herein. 
    
    
     FIELD OF THE DISCLOSURE 
     Embodiments of devices and related methods for improved oral medical apparatus are disclosed. 
     BACKGROUND 
     An oral or nasal medical apparatus relates to devices used to eliminate upper airway obstruction and facilitate oxygenation and ventilation in patients. These devices include the oropharyngeal airway, nasopharyngeal airway, endotracheal tube, laryngeal mask, and face-mask ventilation. An oropharyngeal airway (OPA), also referred to as an oral airway, is used to create an air passageway between the mouth and the posterior pharynx. Patients with sleep apnea, patients under anesthesia, or other patients with an obstructed airflow, may have an oral airway inserted to facilitate airflow. 
     Currently available oral airways include an outer surface made of a hard, rigid piece of plastic in a patient&#39;s mouth that is often poorly tolerated in conscious and semi-conscious patients. For instance, such rigid oral airways may induce gagging, vomiting, aspiration, layrngospasm, damage to teeth (due to patient biting), and damage to lips. If such an oral airway is left in place for a prolonged period of time, sores and swelling can develop in the mouth and tissue damage may occur. Improper sizing of these oral airways introduces problems as well. Given the rigid nature of oral airways, sizing must be done without error. A rigid oral airway that is too large can close the epiglottis and cut off an air supply. A rigid oral airway that is too small can cause tongue sores and swelling, and can also cause the airway to be obstructed by pharyngeal tissue if it fails to extend past the uvula. 
     Nasopharyngeal airways, also referred to as nasal airways, are also used to alleviate airway obstructions. They create an air passageway between the nose and posterior pharynx. Nasal airways may cause discomfort, increase heart rate and blood pressure, and can cause nasal injury and nosebleeds. 
     Endotracheal tubes (ETT) are inserted beyond the vocal cords into the trachea, which is farther into the oral passageway than an oral airway. ETTs are somewhat flexible and compressible, which enables a patient to collapse the ETT by biting, which can cut off the air supply and lead to hypoxia and/or negative pressure pulmonary edema. One advantage ETTs have over oral and nasopharyngeal airways is that they include an inflatable portion which creates a seal in the airway. This prevents oxygen diffusion into the surgical field. 
     Most laryngeal mask airway (LMA) are also flexible and compressible and are seated above the vocal cords. The patient can bite the LMA, collapse it, and cause an airway obstruction. The LMA also prevents oxygen diffusion into the surgical field. 
     Face-mask ventilation is commonly used to manually assist or control ventilation and breathing for the patient and to deliver oxygen, with or without an oral or nasopharyngeal airway. Delivery of oxygen via a mask can be compromised with an improper seal by facial hair, variations in facial structure, deficient dentition, and obesity. Inadequate ventilation and oxygenation can lead to hypoxia causing cell death, decrease in cognitive functioning, coma or death. 
     Patents under monitored anesthesia care (MAC) receiving supplemental oxygen via open delivery systems have an increased operating room fire risk. When patients require supplemental oxygen, as needed with heavy sedation for a procedure above the sternum, the electrocautery and oxygen become close in proximity, increasing the fire risk. Decreasing the oxygen concentration diffusion into the surgical field and supplying oxygen closer to the vocal cords, decreases the risk of a potential surgical fire and increases patient safety. 
     SUMMARY 
     In one embodiment, an oral medical apparatus is an airway apparatus that includes a flexible tube having a proximal end, a distal end, a flange at the proximal end, an upper portion adjacent to the flange, a lower portion between the upper portion and the distal end, and a lumen that extends from the proximal end to the distal end. The flange has an outer diameter that is greater than an outer diameter of the upper portion. The upper portion has an outer diameter that is greater than that of the lower portion. The lumen of the upper portion has a greater inner diameter than that of the lower portion. The airway apparatus also includes a non-compressible tube positioned within lumen of the upper portion of the tube that provides radial support of the upper portion. The non-compressible tube has an open interior that communicates with the lumen of the lower portion, and has an inner diameter that is generally the same as that of the lumen of the lower portion. The open interior of the non-compressible tube allows airflow from the proximal end to the distal end of the flexible tube. 
     Other aspects of the invention will become apparent by consideration of the detailed description and accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a partial longitudinal cross-sectional view of an airway apparatus according to one embodiment of the disclosure. 
         FIG. 1A  is a top side view of the airway apparatus of  FIG. 1 . 
         FIG. 1B  is a longitudinal cross-sectional view of the airway apparatus of  FIG. 1A  taken along line C-C. 
         FIG. 1C  is an end view of the airway apparatus of  FIG. 1A . 
         FIG. 2  is a first side view of the airway apparatus of  FIG. 1 . 
         FIG. 3  is a second side view of airway apparatus tube of  FIG. 1 . 
         FIG. 4  is a front view of the airway apparatus of  FIG. 1 . 
         FIG. 5  is a rear view of the airway apparatus of  FIG. 1 . 
         FIG. 6  is a perspective view of one embodiment of a support for the airway apparatus of  FIG. 1 . 
         FIG. 7  is a side view of the support of  FIG. 6 . 
         FIG. 8  is an enlarged partial view of a proximal portion of the airway apparatus of  FIG. 1 . 
         FIG. 9  illustrates the airway apparatus of  FIG. 1  positioned in the oral cavity of a patient. 
         FIG. 10  is a diagrammatic longitudinal cross-sectional view of a proximal portion of an alternative embodiment of support structure for an airway apparatus. 
         FIG. 11A  is a diagrammatic longitudinal cross-sectional view of the airway apparatus of  FIG. 10  in use with a coupler to connect the airway apparatus to a medical breathing device. 
         FIG. 11B  is a side perspective view of an alternative coupler for use with the airway apparatus of  FIG. 10 . 
         FIG. 12  is a diagrammatic longitudinal cross-sectional view of an alternative embodiment of a support structure for an airway apparatus. 
         FIG. 13  is a diagrammatic longitudinal cross-sectional view of an alternative embodiment of a support structure for an airway apparatus. 
         FIG. 14A  is a diagrammatic longitudinal cross-sectional view of an alternative embodiment of an airway apparatus with a support structure. 
         FIG. 14B  is a diagrammatic longitudinal cross-sectional view of an alternative embodiment of an airway apparatus with alternative embodiments of a support structure that incorporates a flange and an optional coupler for connecting another medical device. 
         FIG. 15A  is a diagrammatic longitudinal cross-sectional view of an alternative embodiment of a helical support structure for an airway apparatus. 
         FIG. 15B  is a diagrammatic longitudinal cross-sectional view of one alternative embodiment of an annular support structure for an airway apparatus. 
         FIG. 15C  is a diagrammatic longitudinal cross-sectional view of an additional alternative embodiment of a support structure for an airway apparatus. 
     
    
    
     DETAILED DESCRIPTION 
     Before any embodiments of the oral airway apparatus are described in detail, it is to be understood that the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings are exemplary and are not intended and should not be construed to limit the scope of the claims. The oral airway described herein is capable of other embodiments and of being practiced or of being carried out in various ways consistent with this specification. Various aspects or features of the oral airway apparatus disclosed herein may be used alone or in combination with other disclosed aspects or features. 
       FIGS. 1, 1A -C,  8 , and  9  illustrate an airway apparatus  100  comprising a tube  105  and a support  110  positioned with an upper portion of tube  105 , and a lumen  115 . With reference to FIGS. 2-5, the illustrated tube  105  is a flexible and compressible tube made of, for instance, a latex free, soft thermoplastic elastomer, such as Mediprene® from Hexpot TPE, having a durometer of about shore A 50, or between about shore A 40-80. The illustrated tube  105  includes, a flange  125  at a proximal end of tube  105 , an upper portion  120  adjacent to flange  125 , and a lower portion  130  that extends from the upper portion  120  to a distal end  135 . As illustrated, flange  125  is circular, although flange  125  may have other shapes such as oval, square, or rectangular. Lumen  115  extends from the proximal end to the distal end  115 . In one embodiment, distal end  135  is blunt and may include a bevel. The outer surface of the upper portion  120  has an outer diameter less than an outer diameter of flange  125 , and transitions at  138  to the lower portion  130 , which has an outer diameter less than that of the upper portion. In the illustrated embodiment, flange  125  has an outer diameter of about 2.0 to about 3.0 centimeters, and the upper portion  120  has an outer diameter of about 1.6 to about 2.1 centimeters. In other embodiments, where flange  125  is not symmetrical about its axis, at least a portion of flange  125  has an outer diameter of about 2.0 to about 3.0 centimeters. In one embodiment, the transition portion  138  includes an outer diameter that gradually decreases from the upper portion  120  to the lower portion  130 , providing a radially tapering profile in the view of  FIG. 1 . In the upper portion  120 , lumen  115  defines a cavity  140  that has a greater inner diameter than the inner diameter of the lumen in the lower portion  130 . In one embodiment, the inner surface of the tube includes a radial shoulder  143  defined by the transition of the inner diameter of the lumen  115  from the upper portion  120  to the lower portion  130 . In one embodiment, a plurality of protrusions  144  are formed on the inner surface of the cavity  140 . In the illustrated embodiment, the upper portion  120  includes eight protrusions  144   a ,  144   b ,  144   c ,  144   d ,  144   e ,  144   f ,  144   g ,  144   h ; however, in alternative embodiments, the upper portion  120  may include at least one or more protrusions  144 . In one embodiment, the protrusion may be annular in shape. As shown in  FIG. 12 , in one embodiment, an annular protrusion  144   i  is located on the support  110  adjacent flange  125  at the proximal end of tube  105 , and is over-molded by flange  125 . As shown in  FIG. 13 , in one embodiment, an annular protrusion  144   j  is extends from the outer surface of support  110  at a location along the length of support  110 . In alternative embodiments, the protrusions  144  are omitted (see, e.g.,  FIG. 10 ). 
     The tube  105  is designed in several sizes to accommodate the various pharynx sizes of patients. Below is an exemplary size chart for portions of the tube  105  based on estimated pharynx sizes by patient age. The size, length and diameter of the tube  105  are merely exemplary and should not be interpreted as limiting. 
     
       
         
           
               
               
               
               
            
               
                   
                   
               
               
                   
                 Lower 
                 Lower 
                   
               
            
           
           
               
               
               
               
               
            
               
                   
                 Lower 
                 portion 
                 portion 
                 Upper 
               
               
                   
                 portion 
                 130 Inner 
                 130 Outer 
                 portion 
               
            
           
           
               
               
               
               
               
            
               
                 Patient 
                 130 Length 
                 Diameter 
                 Diameter 
                 120 Length 
               
               
                 Age 
                 (mm) 
                 (mm) 
                 (mm) 
                 (mm) 
               
               
                   
               
            
           
           
               
               
               
               
               
               
            
               
                 0-6 
                 mo 
                 70 
                 3.2 
                 6.7 
                 34 
               
            
           
           
               
               
               
               
               
            
               
                 6 mo-1 yr 
                 80 
                 3.9 
                 7.4 
                 35 
               
            
           
           
               
               
               
               
               
               
            
               
                 1-4 
                 yr 
                 90 
                 4.5 
                 8.0 
                 36 
               
               
                 5-8 
                 yr 
                 100 
                 5.2 
                 8.7 
                 36 
               
               
                 8-10 
                 yr 
                 110 
                 5.9 
                 9.4 
                 38 
               
            
           
           
               
               
               
               
               
            
               
                 Adult 
                 130 
                 6.5 
                 10 
                 40 
               
               
                 female 
               
               
                 Adult 
                 150 
                 7.4 
                 10.7 
                 40 
               
               
                 large male 
               
               
                   
               
            
           
         
       
     
     With reference to  FIGS. 6 and 7 , in one embodiment, the illustrated support  110  is generally a tubular sleeve having an outer surface  110   a  and an inner surface  110   b . Outer surface  110   a  has an outer diameter sized to fit within the inner diameter of cavity  140  of upper portion  120 . Inner surface  110   b  has an inner diameter that is generally the same as the inner diameter of the lumen in the lower portion  130 . In one embodiment, support  110  is made of a hard (e.g., non-compressible) medical grade polypropylene or polyethylene terephthalate in a molding process. In one embodiment, support  110  has a slightly curved axis  145 ; however, in other embodiments, the support  110  has a straight linear axis. In one embodiment, support  110  includes a tapering inner and outer diameter that reduces in dimension from a first end  150  to a second end  155  of support  110 . As positioned within cavity  140 , first end  150  of support  110  is located adjacent the flange  125  and the second end  155  is adjacent to the lower portion  130  in contact with radial shoulder  143 . Radial shoulder prevents movement of support  110  in the distal direction. In other embodiments, the support  110  may include a uniform inner and/or outer diameter (See  FIG. 10 ). In the illustrated embodiment, the insert  110  includes a plurality of apertures  160  (e.g., apertures  160   a ,  160   b ,  160   c ,  160   d ,  160   e ,  160   f ,  160   g ,  160   h ). In other embodiments, the insert  110  may include more or less than eight apertures  160 . In further embodiments, the apertures  160  may be omitted. In yet alternative embodiments, Support  110  may comprise, for example, a structural framework that provides radial support to upper portion  120  of tube  105 , such as a helical member  111  or a plurality of linearly spaced annular members  113 , as shown in  FIGS. 15 a  and 15 b   . Helical member  111  and annular members  113  may be made of a medical grade metal or polymer. As shown in  FIG. 15 c   , in one embodiment, support  110  can be molded within the wall of upper portion  120 . 
     In one embodiment, support  110  is secured from movement within the cavity  140  by each protrusion  144  engaging a corresponding aperture  160  (e.g., the first protrusion  144   a  engages the first aperture  160   a ). In an alternative embodiment, where the protrusions  144  and the apertures  160  are omitted, support  110  may be held within the cavity  140  by a frictional interference fit. As shown in  FIG. 10 , in an alternative embodiment, airway apparatus  100  may be made in a two-shot molding process, with support  110  molded in the first shot, and tube  105  molded over support  110  in a second shot, which secures support  110  within tube  105 . In other embodiments, support  110  may be selectively removable from the cavity  140  by disengagement of the protrusions  144  and the corresponding apertures  160 . In further embodiments, the outer surface of support  110  may be fixed to the inner surface of cavity  140  by a medical grade adhesive. 
     The airway apparatus  100  is operable to be directly or indirectly coupled to a medical breathing device, for example, an anesthesia circuit, manual resuscitator/self-inflating bag, which will be referred to as a medical breathing device hereafter, or may not be coupled to another device. For example, as shown in  FIG. 11A , a tubular connector  181  having a first tubular portion  182  and a second tubular portion  184  and a lumen  186  may be used to couple the airway apparatus  100  to such medical breathing devices. The outer surface diameter of first tubular portion  182  is sized to attach to a coupler of a medical breathing device, while the outer surface diameter of the second tubular portion  184  is sized to fit within and frictionally engage inner surface  110   b  of support  110 . Alternatively, as shown in  FIG. 11B , a tubular connector  181   a  having a first tubular portion  182   a , a second tubular portion  184   a , a lumen  186   a , and a flange/separator  188  between the first tubular portion  182   a  and the second tubular portion  184   a  may be used to couple the airway apparatus  100  to such medical breathing devices. Here, the second tubular portion  184   a  of the connector  181   a  is insertable into support  110 , and the first tubular portion  182   a  receives or is inserted into a connecting portion of a medical breathing device, such as previously described. The separator  188  serves to prevent airway apparatus  100  from entering the oral cavity of a patient. Separator  188  may have other shapes as previously discussed in reference to flange  125 . A similar connector is disclosed, for example, in U.S. Pat. No. 8,631,795, which discloses an airway used in combination with a connector to be coupled to an anesthesia circuit, or a medical breathing device, the disclosure of which is incorporated herein by reference. Airway apparatus  100  used with a connector that incorporates a separator between the first and second tubular ends can thus be formed without flange  125 , with the separator preventing the airway apparatus from entering the oral cavity of a patient. In some instances, the connector is integral with the medical breathing device and the airway apparatus  100  is, therefore, directly coupled to the medical breathing device via the integral connector. The connector can also be directly coupled to a medical breathing device, which delivers oxygen closer to the vocal cords. With reduce diffused oxygen around the surgical field the fire risk will be dramatically eradicated. 
     The airway apparatus  100  can be used without a tubular connector  181  with or without an oxygen source. With reference to  FIG. 9 , the bevel end  135  of the tube  105  is designed for comfort and gentle insertion into a patient&#39;s airway (e.g., the pharynx of a patient  165 ). In the illustrated embodiment, the bevel end  135  does not extend beyond the epiglottis  170  of the patient  165 . When flange  125  contacts the exterior surface of the patient&#39;s face around the mouth, the flange  125  prevents the airway apparatus  100  from entering the oral cavity  175  of the patient  165 , and locates the upper portion  120  such that the upper portion  120  generally extends to the molars of the patient  165 . In an alternative embodiment, flange  125  can be omitted from the flexible tube  105 , in which case flexible tube  105  is held in position by securing it to the patient with, for example tape (See, e.g.,  FIG. 14A ). Alternatively, as shown in  FIG. 14B , support  110  can incorporate a flange  121  that is external to the proximal end of tube  105 , as well as an optional coupler  123  (shown in phantom) that can extend from flange  121  and allow for connection of another medical device, such as a medical breathing device. 
     The use of support  110  within the upper portion  120  of flexible tube  105  prevents the patient  165  from biting down and closing off the airway  115 . Moreover, the flexible tube  105  surrounds support  110  so that the flexible tube  105  provides cushioning to prevent the patient  165  from harming their teeth in the event the patient bites on the airway apparatus  100 . As illustrated, (e.g., in  FIG. 1 ), the upper portion  120  includes a larger outer diameter than the lower portion  130 . The larger diameter of the upper portion  120  is, at least in part, due to the increase in thickness of the wall of flexible tube  105  at the upper portion  120  relative to the lower portion  130 . In one embodiment, the wall thickness of the upper portion  120  is about 4.0 to about 12.0 millimeters. In alternative embodiments, the wall thickness of the flexible tube  105  is uniform between the upper portion  120  and lower portion  130 , and still provides cushioning for the rigid insert  110 . 
     The airway apparatus  100  can be inserted into the airway cavity  180  of the patient  165  to create a patent airway. In some instances, airway apparatus  100  can be used to eliminate obstructions in the upper airway, such as caused by sleep apnea. Additionally, airway apparatus  100  can reduce or eliminate snoring when worn by a sleeping patient. The airway apparatus  100  also can be used to create airways in animals in veterinary applications. 
     Airway apparatus  100  can also be used with other medical devices. For example, an oxygen mask can be placed over the patient&#39;s nose and mouth or nasal cannula in the OMA to improve oxygenation and ventilation. Also, an OMA can be inserted alongside of the ETT or laryngeal mask airway (LMA) to prevent the patient from biting and collapsing the ETT or LMA. A medical breathing device can be coupled to the connecting portion to provide intraoral ventilation. An anesthesia breathing circuit can be coupled to the connecting portion to decrease the fire risk and improve ventilation. 
     Airway apparatus  100  eliminates upper airway obstruction in patients by keeping the airway patent. It consists of a flexible tube with a built in non-collapsible cushioned bite block that can be coupled with a rigid connector. Airway apparatus  100  eliminates many of the adverse effects associated with the currently used oropharyngeal airway (OA) and nasopharyngeal/nasal airway (NA). The airway apparatus lowers the risk of oral and nasal injury seen in OA and NA use. It also eliminates the concern of airway collapse due to biting, and prevents damage to other medical devices, such as when used alongside of an endotracheal tube (ETT), a laryngeal mask airway (LMAs), or other device. Airway apparatus  100  provides an alternative to a difficult mask ventilation by use with the rigid connector that may be directly coupled to an anesthesia breathing circuit or a medical breathing device. The connector can also be connected directly to an oxygen source, which decreases the fire risk associated with supplemental oxygen via open delivery systems. Finally, the decreased need for a jaw thrust/chin lift when applying the airway provides an easy hand off approach to airway management. 
     Thus, the airway apparatus disclosed provides, among other things, an enhanced airway to provide a safe, comfortable airway in a patient. Furthermore, the disclosed apparatus may be adapted for use in or in association with other medical devices that are inserted into the mouth of a patient, such as, e.g., endotracheal tubes, laryngeal mask airways, supraglottic airways, endoscopes, fiberoptics, esophageal catheters, and the like. Various aspects of the airway apparatus  100  are set forth in the following claims.