Abstract:
An oral airway providing a patent airway to a patient, supplies oxygen to the patient and monitors expelled gases during endoscopic or intubating procedures. The oral airway includes a central lumen and two lateral breathing channels. A bracket at the proximal end of the oral airway functions to guide an oxygen supply line and an end tidal carbon dioxide monitoring line into the lateral breathing channels and to act as a barrier beyond which the airway cannot be inserted into the mouth of the patient. The airway has a straight main central lumen which serves as a guide and conduit to facilitate endoscope, bronchoscope, or fiber optic bronchoscope placement and manipulation.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part application of co-pending U.S. patent application Ser. No. 11/838,975 entitled “ORAL CANNULA AIRWAY” filed on Aug. 15, 2007 under the name of Andrea R. Williams which claims the priority date of Provisional Patent Application No. 60/851,506 filed Oct. 13, 2006 and is hereby incorporated by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    This invention relates to medical devices. Specifically, the present invention relates to an oral airway for maintaining a patent airway for spontaneously ventilating patients undergoing sedation for surgical, endoscopic, bronchoscopic, and fiber optic intubation procedures. 
         [0004]    2. Description of the Related Art 
         [0005]    Each year in the United States, more than twenty million surgeries are performed on an outpatient basis. With these surgeries, as well as those performed in office-based surgical practices, regional/local anesthesia and intravenous sedation are growing in popularity as the preferred sedation method. Nurses having little or no specialized anesthesia training are administering intravenous sedation for a growing number of procedures. Compared to general anesthesia, patients can recover more quickly and experience less postoperative pain and nausea and vomiting, while experiencing greater satisfaction and more rapid discharge to their homes. 
         [0006]    Airway emergencies are the most common complication during moderate and deep procedural sedation. One of the earliest indications of airway compromise is a change in end tidal carbon dioxide (ETCO 2 ). Currently, there are several options to manage the airway of sedated patients: oral endotracheal tubes (OETT); the laryngeal mask airway (LMA); and the cuffed oral pharyngeal airway (COPA). All of these options require advanced training and connection of the device to some external form of supplemental oxygen or an anesthesia circuit, and are not available to the non-anesthesia trained nurse. 
         [0007]    As discussed in co-pending U.S. patent application Ser. No. 11/838,975, a nasal oxygen cannula is typically used to supplement oxygen in patients under sedation who are able to maintain an unobstructed airway, and is frequently accompanied by ETCO 2  monitoring. The nasal oxygen cannula is not, however, capable of assisting the patient in maintaining a clear airway. Since patients under sedation often experience relaxed oral or pharyngeal tissues which may interfere with breathing, additional mechanical assistance may be required to maintain a patent airway in these circumstances. Additionally, sedated patients undergoing procedures through the mouth, such as endoscopy and bronchoscopy, frequently experience airway obstruction. Although OETT, LMA and COPA provide this mechanical assistance, they are poorly tolerated by patients unless deep sedation or general anesthesia is administered. 
         [0008]    Although there are no known prior art teachings of a solution to the aforementioned deficiency and shortcoming such as that disclosed herein, prior art references that discuss subject matter that bears some relation to matters discussed herein are U.S. Pat. No. 7,278,420 to Ganesh et al. (Ganesh), U.S. Pat. No. 4,683,879 to Williams (Williams), and U.S. Pat. No. 6,098,617 to Connell (Connell). 
         [0009]    Ganesh discloses an oropharyngeal device for insertion into the mouth of a patient. The device includes a distal end and proximal end having a flange formed at the proximal end. The body is sized such that the distal end of the body is disposed within the pharynx above the epiglottis. The device includes at least three separate conduits integrated into the body for administering oxygen, suctioning and for assessing ventilation through end-tidal carbon dioxide monitoring. However, Ganesh does not disclose a device for use in maintaining an airway during endoscopic or intubating procedures. Furthermore, Ganesh suffers from the disadvantage of placing the end-tidal carbon dioxide monitoring conduit near the proximal end of the device, which is not the most advantageous position to obtain accurate readings from the patient. 
         [0010]    Williams discloses a dual function connector for releasable attachment to an endopharyngeal tube or airway intubator. However, Williams does not teach or suggest a device for maintaining an airway, providing oxygen supplementation, or ETCO 2  monitoring for a patient. 
         [0011]    Connell discloses a device adapted for use with a conventional oral or nasopharyngeal airway for delivering an inhalant gas to a proximal end of the airway and for sampling exhalent gas at a distal end of the airway. However, Connell does not teach or suggest a device for use in maintaining an airway during an endoscopic or intubating procedure. 
         [0012]    It would be an advantage to have a device which maintains a patent airway, provides for oxygen supplementation and ETCO 2  monitoring in spontaneously ventilating, sedated patients as well as allows the placement and use of scopes in various medical procedures. Furthermore, a device is needed which enables the airway device to be used by non-anesthesia trained medical providers. It is an object of the present invention to provide such an apparatus. 
       SUMMARY OF THE INVENTION 
       [0013]    In one aspect, the present invention is directed to an oral airway. The airway includes a main central lumen having a proximal end and an opposite distal end. The main central lumen contains an enlarged straight hollow oral airway which is large enough to accommodate and manipulate an endoscope or bronchoscope. The oral airway includes two lateral breathing channels located on opposite sides of the main lumen. Oxygen and ETCO2 are supplemented and monitored respectively through the lateral breathing channels. At the proximal end of the oral airway, a bracket guides and secures an ETCO 2  line and an O 2  line into the interior of the airway. The bracket also acts as a barrier, beyond which the airway cannot be inserted into the mouth of a patient. On the proximal side of the bracket, the ETCO 2  line and the O 2  line extend to an ETCO 2  monitor and an oxygen supply, respectively. On the distal side of the bracket, the O 2  line enters and extends into the proximal third of one of the breathing channels, allowing for supplemental oxygen to be supplied to the oral airway. Also on the other distal side of the bracket, the ETCO 2  line enters the other lateral breathing channel and extends through the oral airway to the middle third of the breathing channel, allowing carbon dioxide sampling as expelled gases from a patient enters the distal end of the lumen. 
         [0014]    In another aspect, the present invention is directed to an oral airway system. The oral airway includes a main central airway lumen having a straight passageway allowing accommodation of endoscopes and bronchoscopes. The main central airway lumen has a proximal end and an opposite distal end. The oral airway also includes a gas supply line located in a first breathing channel adjacent to the airway lumen. Additionally, the oral airway includes a gas monitoring line located in a second breathing channel adjacent to the airway lumen for monitoring gases expelled from a patient. A gas monitoring system is connected to the gas monitoring line. The oral airway system also includes a gas supply system connected to the gas supply line. The oral airway is inserted into the mouth of the patient so that the distal end is placed in the patient&#39;s pharynx and the proximal end remains outside the mouth of the patient. The gases expelled by the patient are sent through the gas monitoring line to the gas monitoring system. The gas supply system supplies gas through the gas supply line to the patient. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0015]      FIG. 1  is a front perspective view of an oral airway in the preferred embodiment of the present invention; 
           [0016]      FIG. 2  is a front interior view of the main airway lumen of  FIG. 1 ; 
           [0017]      FIG. 3  is a right side view of the main airway lumen; 
           [0018]      FIG. 4  is a left side view of the main airway lumen; 
           [0019]      FIG. 5  is a cross section view of the main airway lumen midsection; 
           [0020]      FIG. 6A  illustrates a cross sectional view of the proximal oral airway in the preferred embodiment of the present invention; 
           [0021]      FIG. 6B  illustrates a cross sectional view of the oral airway in an alternate embodiment of the present invention; and 
           [0022]      FIG. 7  is a side view of a connection arrangement of the ETCO 2  and O 2  lines. 
       
    
    
     DESCRIPTION OF THE INVENTION 
       [0023]    An oral airway for use in spontaneously ventilating patients during endoscopic or intubating procedures is disclosed.  FIG. 1  is a front perspective view of an oral airway  10  for use in endoscopic or intubating procedures in the preferred embodiment of the present invention. The oral airway includes a substantially central and straight working channel or airway lumen  12  sized and shaped to accommodate an endoscope or bronchoscope. The airway lumen  12  includes at least two adjacent lateral, curved breathing channels  24  and  32 . The oral airway  10  includes the main airway lumen  12  having a proximal end  14  and a distal end  16 . The lumen  12  is preferably straight for ease in maneuvering and turning scopes within and distal to the lumen as the scopes exit the distal lumen without obstruction or limitation of movement, which may occur with a curved lumen shape. A bracket  18  is preferably secured to the proximal end  14  of the airway lumen  12 . An ETCO 2  line  20  is positioned through the bracket  18  and enters the lateral breathing channel  24  at an entry point  8 . The ETCO 2    20  line preferably extends into the curved lateral breathing channel  24  to an endpoint  26  located in the middle third of the lateral breathing channel  24 . The curved lateral breathing channel  24  preferably extends past the endpoint  26 . In addition, an oxygen (O 2 ) line  28  is positioned through the bracket  18  and enters the opposite lateral breathing channel  32  at an entry point  30 . The O2 line preferably extends into the proximal third of the airway and ends at endpoint  33 . The curved lateral breathing channel  32  continues past  33 . In addition, to securing the ETCO2 line  20  and O2 line  28 , the bracket  18  prevents insertion of the entire airway lumen into the mouth of the patient. The oral airway  10  also includes an extension  35  providing a curved extension with a partially opened portion  37  of the oral airway for scope manipulation and breathing channels to converge. The extension  35  is preferably shaped as a “scoop” which, when utilized in a patient, has the distal end of the extension positioned in the posterior pharynx, posterior and distal to the tongue and proximal to the epiglottis. The extension  35  is important to allow scope maneuvers without impingement by the oral airway itself. 
         [0024]      FIG. 2  is a front interior view of the oral airway  10  of  FIG. 1 .  FIG. 3  is a right side view of the oral airway  10  .  FIG. 4  is a left side view of the oral airway  10 .  FIG. 5  is a cross section of the oral airway  10  at the midsection of the lumen  12 . The oral airway  10  preferably has a curved portion  41  and a flat straight side  43 , thereby providing a “half moon” shape cross section. The oral airway  10  includes the airway lumen  12  for accommodating endoscopes, bronchoscopes or other surgical instruments. The lateral breathing channel  24  is located adjacent to the airway lumen having the ETCO 2  line  20  within the interior of the lateral breathing channel  24 . In addition, the lateral breathing channel  32  is located on an opposite side of the channel  24 . 
         [0025]    In the preferred embodiment of the present invention, the O 2  line  28  enters the lateral breathing channel at the proximal end and includes an entry point into the passageway of the lateral airway breathing channel lumen extending approximately two centimeters into the lateral breathing channel. The channel preferably is 0.75 centimeters wide and approximately two centimeters in height. The ETCO 2  line  20  enters the opposite lateral breathing channel at the proximal end and preferably extends into the lateral breathing channel approximately four centimeters. The associated breathing channel is also preferably 0.75 centimeters wide with an approximate height of two centimeters. In the preferred embodiment of the present invention, the length of the oral airway is in the range of 8.0-10.0 centimeters for adults. For children, the oral airway may be smaller. 
         [0026]      FIG. 6A  illustrates the cross sectional of the oral airway  10 . As discussed above, the oral airway preferably has a half-moon shape which provides stability for the airway such that manipulation of scopes in the airway does not cause it to roll or turn in the patient&#39;s mouth. As shown in  FIG. 6A , the breathing channels are separated from each other and the lumen  12 . By separating the breathing channels, a more accurate sampling of ETCO2 may occur because of less dilution and distortion of the ETCO2 tracing from inspired oxygen. 
         [0027]      FIG. 6B  illustrates a cross sectional view of the oral airway in an alternate embodiment of the present invention. A single breathing channel  56  may surround the lumen  12  and accommodate both the O 2  line  28  and the ETCO 2  line  20 . [ 
         [0028]      FIG. 7  is a side view of a connection arrangement  40  of the ETCO 2  line  20  in the preferred embodiment of the present invention. Referring to  FIGS. 1 and 7 , the ETCO 2  line  20  extends from the bracket  18  to a female luer connector  50 . The female luer connector may be connectable to a male luer  52 . The male luer  52  is a standard connection to the ETCO 2  sample line connecting to the ETCO 2  monitor. Alternatively, the male luer may be secured to an adapter line  54  having an adapter female connector  56 . A plain, thin ETCO 2  sample line without a male connector from the ETCO 2  monitor may be inserted into connector  56 . The O 2  line  28  extends from the bracket  18  and may include a connector  60  located on an end  62 . The O 2  line connector  60  attaches to the O 2  line which attaches to any standard “Christmas tree” connector to an O 2  source. The O 2  line and the ETCO 2  lines are preferably constructed of flexible plastic tubing common in medical devices. 
         [0029]    In the preferred embodiment of the present invention, the ETCO 2  line is preferably located inside the middle third of the lateral breathing channel  24  (e.g., approximately 4 centimeters from the proximal end  8 ) to facilitate accurate measurement of the expired carbon dioxide. The O 2  line is preferably in the opposite lateral breathing channel  32 , approximately two centimeters proximal to the ETCO 2  line. This location ensures delivery of oxygen to the lower oral pharyngeal airway with minimal interference in ETCO 2  tracing. The proximal ends of the sampling and delivery tubing are preferably connected to the ETCO 2  monitor and to any oxygen supply system via a double lumen oxygen delivery line with an ETCO 2  sampling channel. In addition, the lateral breathing channels are large enough for a separate suctioning line to pass if necessary. 
         [0030]    The oral airway  10  maintains a patent airway as the firm non-traumatic distal end  35  creates a patent breathing channel which supports the relaxed soft tissues of the sedated patient and facilitates endoscope and bronchoscope use. The oxygen delivery system (O 2  line  28 ) utilized with the present invention may be directly connected to a wall or tank O 2 , or the oxygen flow system of any standard anesthesia machine. The ETCO 2  line  20  may connect to any ETCO 2  monitoring system via a standard universal female/male luer connector. The present invention does not require connection to the ventilator/anesthesia circuit. If a patient requires assisted ventilation, this may be provided by bag/mask ventilation while still providing airway support, supplemental oxygen, and ETCO 2  monitoring. 
         [0031]    With reference to  FIGS. 1-7 , the operation of the oral airway  10  will now be explained. The oral airway  10  may be used in conjunction with an ETCO2/O2 nasal cannula (not shown). In this case, sedation using normal procedures known to the art is commenced before a surgical or medical procedure, endoscopic or bronchoscopic exam, or fiber optic intubation. The nasal cannula is also placed using normal procedures known to the art. After adequate moderate to deep levels of sedation have been reached and the patient&#39;s glossopharyngeal reflexes have been suppressed, the distal end  35  is inserted into the patient&#39;s mouth so that the portion of the main airway lumen  12  which is not in the patient&#39;s mouth curves up in the direction of the patient&#39;s nose. As the main airway lumen  12  is advanced into the patient&#39;s mouth, it must be rotated 180 degrees as it passes into the pharynx. In the fully inserted position, the proximal end  14  is in the patient&#39;s mouth, except for the bracket  18  which prevents further advancement of the lumen. The bracket  18  remains outside the patient&#39;s lips, and the distal end is curved along the pharynx. 
         [0032]    With the main airway lumen  12  in place, an ETCO 2  monitor line and an oxygen supply line (not shown) are disconnected from the nasal cannula and connected to the ETCO 2  line  20  and the O 2  line  28  in the respective lateral breathing channels  24  and  32 . 
         [0033]    Once the medical procedure is complete and the patient begins to awaken, the ETCO 2  line  20  and the O 2  line  28  are disconnected from the ETCO 2  monitor and O 2  supply, respectively, and reattached to the nasal cannula. The main airway lumen  12  may then be withdrawn by medical personnel or alternatively by action of the patient&#39;s tongue or mouth. 
         [0034]    The oral airway  10 , in the preferred embodiment of the current invention, may also be used without an accompanying nasal cannula. The ETCO 2  line  20  and the O 2  line  28  are connected to the ETCO 2  monitor and O 2  supply, respectively, before insertion of the main airway lumen  12 . The distal end  35  of the main airway lumen  12  is inserted into the patient&#39;s mouth and held between the patient&#39;s lips with the remainder of the lumen curving up toward the patient&#39;s nose as above. As sedation of the patient begins and the glossopharyngeal reflexes have been suppressed, the main airway lumen  12  is advanced into the pharynx and rotated 180 degrees as the distal end  35  passes into the posterior pharynx. Following the medical procedure, when the patient begins to regain glossopharyngeal reflexes, the insertion procedure is reversed and the main airway lumen is withdrawn until only the distal end  35  remains in the patient&#39;s mouth. As the patient awakens and can respond to verbal instructions, the patient is asked to open his mouth and the main airway lumen  12  is fully removed. 
         [0035]    In an alternate embodiment of the present invention, the main airway lumen  12  may not include a bracket. The proximal end  14  of the main airway lumen may be wider than the main body of the main airway lumen to prevent insertion of the entire main airway lumen  12  into the mouth of a patient. It should also be understood by those skilled in the art that the main airway lumen may be shaped in any fashion which allows the insertion of the oral cannula airway  10  into the patient&#39;s mouth. Additionally, the ETCO 2  line  20  and the O 2  line  28  may be positioned anywhere within the interior of the main airway lumen and still remain in the scope of the invention. The ETCO 2  line  20  may monitor expel gases other than carbon dioxide. In addition, the O 2  line  28  may provide gases other than oxygen to the patient. 
         [0036]    The present invention provides many advantages over existing airway devices. The present invention provides a simple method to maintain an open airway, administer supplemental oxygen and monitor expired gases. It is ideal for maintaining a patent airway in spontaneously ventilating surgical patients undergoing procedures where local or regional anesthesia and moderate to deep sedation with sedative drugs are employed. It maintains a patent airway in spontaneously ventilating sedated patients undergoing endoscopy, bronchoscopy or fiber optic intubation. In addition, it may be used by providers not specially trained in anesthesia procedures for administering intravenous procedural sedation. 
         [0037]    While the present invention is described herein with reference to illustrative embodiments for particular applications, it should be understood that the invention is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, and embodiments within the scope thereof and additional fields in which the present invention would be of significant utility. 
         [0038]    Thus, the present invention has been described herein with reference to a particular embodiment for a particular application. Those having ordinary skill in the art and access to the present teachings will recognize additional modifications, applications and embodiments within the scope thereof. 
         [0039]    It is therefore intended by the appended claims to cover any and all such applications, modifications and embodiments within the scope of the present invention.