Abstract:
A conscious sedation airway, CSA, useable during conscious or unconscious sedation. The CSA includes an elongate body with an anterior flange depending therefrom. The body includes a central portion with superior and inferior plates extending a distance beyond a distal end of the body in an inferiorly curved arrangement. A midline opening and two lateral openings extend through the length of the central portion and are configured to receive apparatus, like endoscopes, cannula, and catheters. The superior and inferior plates aid to maintain a position of the tongue and to guide apparatus inserted through the midline opening toward the posterior oropharynx. The anterior flange prevents swallowing the CSA. The body does not extend into the pharynx to enable use in conscious patients and/or those with intact gag reflexes. And a nasopharyngeal airway can be placed without removing the CSA to allow bag ventilation of the patient.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Patent Application No. 61/778,922 filed Mar. 13, 2013, the disclosure of which is hereby incorporated herein, in its entirety, by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to medical devices, and more particularly to a multi-functional conscience sedation airway that is also useable in the unconscious patient when desired. 
       BACKGROUND 
       [0003]    Oral or nasal airways are known in the art, and are used to maintain a patent airway in the unconscious patient. There are currently two popular airway devices that are used during airway management of the obstructed airway. The oropharyngeal airway, (OPA), is inserted into the mouth to prevent the tongue from resting against the posterior pharyngeal wall. The disadvantages to using the OPA include increased airway obstruction if placed incorrectly, trauma to soft tissue by catching the tongue or lips, and induced vomiting or coughing with a patient with intact airway reflex. The nasopharyngeal airway, (NPA), is also used to assist with the airway obstruction. It is less irritating; however, there are adverse effects as well. These effects include entry into the esophagus when the NPA is too long, injury to nasal mucosa, which can lead to bleeding and aspiration of blood clots and loss of the airway, e.g. swallowing of the airway, if there is no flange around the NPA. 
         [0004]    Therefore, there is a need for a conscious sedation airway that can be inserted into the conscious patient during sedation cases and that can be used during gastrointestinal procedures. Such a conscious sedation airway that can also provide oxygen via a cannula, enable suction, enable insertion of a nasopharyngeal airway through the conscious sedation airway, and allow the patient to be safely bag ventilated if the patient becomes unconscious during sedation, (without necessitating the removal of the device from the patient) is also needed. The present invention accomplishes these objectives. 
       SUMMARY 
       [0005]    Embodiments of the invention are defined by the claims below, not this summary. A high-level overview of various aspects of the invention are provided here for that reason, to provide an overview of the disclosure, and to introduce a selection of concepts that are further described in the Detailed-Description section below. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in isolation to determine the scope of the claimed subject matter. In brief, this disclosure describes, among other things a conscious sedation airway (CSA) for insertion into the mouth. 
         [0006]    The CSA has an elongate internal body that is insertable into a patient&#39;s mouth and includes an anterior flange depending from an anterior end thereof. The internal body is shortened compared to known devices and does not insert into the posterior oropharynx such that the device is less intrusive than the OPA or NPA. The internal body includes a central portion with superior and inferior plates extending a distance beyond a distal end of the body in an inferiorly curved arrangement. A midline opening and two lateral openings extend through the length of the central portion and are configured to receive apparatus, such as an endoscope, nasal cannula, catheters for suction, and a nasopharyngeal airway, among others. The inferior plate aids to maintain a position of the tongue and resists movement of the tongue distally toward the posterior oropharynx and thus causing obstruction thereof. The superior plate aids to guide apparatus inserted through the midline opening toward the posterior oropharynx. 
         [0007]    The shortened length of the internal body enables the device to be inserted prior to sedation without triggering the patient&#39;s gag reflex. After sedation is initiated and if the patient becomes obstructed an NPA can be inserted through the midline opening to enable the patient to breath. The midline opening is dimensioned to enable insertion of the NPA therethrough but to obstruct passage of a proximal end of the NPA and prevent inhalation of the NPA into the patient&#39;s airway. 
         [0008]    The CSA may also be employed during endoscopic examinations. The CSA can be inserted prior to sedation being initiated and secured with a head strap that couples to lateral apertures provided on the anterior flange of the CSA. Once the patient is adequately sedated the endoscope can be placed via the midline opening. The internal body of the CSA functions as bite block that prevents the patient from biting the endoscope inserted through the midline opening and potentially damaging the endoscope. 
         [0009]    The configuration of the CSA also enables placement of oxygen cannula via one or both of the lateral openings, permits suctioning through the midline opening, and enables the provider to ventilate the patient with the CSA remaining in the mouth of the patient. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0010]    Illustrative embodiments of the invention are described in detail below with reference to the attached drawing figures, and wherein: 
           [0011]      FIG. 1  is a perspective view of a conscious sedation airway (CSA) illustrated with a nasal cannula and with straps secured thereto in accordance with an embodiment of the invention; 
           [0012]      FIG. 2  is an elevational view of an anterior side of the CSA of  FIG. 1  depicted without the nasal cannula and the strap; 
           [0013]      FIG. 3  is an elevational view of a posterior side of the CSA of  FIG. 1  depicted without the nasal cannula and the strap; 
           [0014]      FIG. 4  is an elevational side view of the CSA of  FIG. 1  depicted without the nasal cannula and the strap; 
           [0015]      FIG. 5  is a diagrammatic side view of a patient with the CSA of  FIG. 1  inserted into the mouth depicted in accordance with an embodiment of the invention; 
           [0016]      FIG. 6  is a diagrammatic side view of a patient with the CSA of  FIG. 1  inserted into the mouth, illustrated as used with a nasopharyngeal airway inserted through the CSA in accordance with an embodiment of the invention; and 
           [0017]      FIG. 7  is a diagrammatic side view of a patient with the CSA of  FIG. 1  inserted into the mouth, illustrated as used with an endoscope placed through the CSA in accordance with an embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0018]    The subject matter of select embodiments of the invention is described with specificity herein to meet statutory requirements. But the description itself is not intended to necessarily limit the scope of claims. Rather, the claimed subject matter might be embodied in other ways to include different components, steps, or combinations thereof similar to the ones described in this document, in conjunction with other present or future technologies. Terms should not be interpreted as implying any particular order among or between various steps herein disclosed unless and except when the order of individual steps is explicitly described. 
         [0019]    Referring initially to  FIGS. 1-5 , a conscious sedation airway (CSA)  10  is described in accordance with an embodiment of the invention. The CSA  10  is described herein with respect to use in humans, but such is not intended to restrict embodiments of the invention. In some embodiments, the CSA  10  can be configured for and employed in procedures in veterinary medicine. The construction and manufacturing of the CSA  10  is conducted using materials and methods known in the art and is not described in detail herein. 
         [0020]    The CSA  10  includes an elongate internal body  12  with an anterior flange  14  disposed at or adjacent an anterior end thereof. The internal body  12  is configured for insertion in the mouth  15  of a patient  17  and includes a central portion  16 , a superior plate  18 , and an inferior plate  20 . The central portion  16  includes a midline opening  22  and a pair of lateral openings  24 ,  26  that flank the midline opening  22 . The openings  22 ,  24 ,  26  extend through the length of the central portion  16  and are open at each end thereof. Three openings  22 ,  24 ,  26  are described herein, however such is not intended to limit the scope of embodiments of the invention to a particular number or arrangement of openings. In embodiments, the provision of three openings  22 ,  24 ,  26  enables the provision of oxygen to the patient  17  as described below, as well as enables monitoring of carbon dioxide levels in the patient, and provides increased air exchange or ventilation of the patient&#39;s breathing. 
         [0021]    The midline opening  22  has dimensions configured to receive apparatus such as a nasopharyngeal airway  46  (NPA)( FIG. 6 ), an endoscope  52  ( FIG. 7 ), suction catheter, nasal cannula  30 , or the like therein. The dimensions may also be configured to enable insertion of a portion of an apparatus through the midline opening  22  but to obstruct complete passage of the apparatus through the midline opening  22 . For example, as depicted in  FIG. 6 , the midline opening  22  may be dimensioned to receive a tube portion  48  of an NPA  46  but to obstruct passage of a flared end  50  of the NPA. Such obstruction to complete passage of apparatus through the midline opening  22  resists or prevents inhalation or loss of the apparatus into the patient. 
         [0022]    The lateral openings  24 ,  26  preferably have a diameter that is smaller than that of the midline opening  22 , but the lateral openings  24 ,  26  may have any desired dimensions. As depicted in  FIG. 1 , the lateral openings  24 ,  26  may be dimensioned to receive a prong  28  of a nasal cannula  30 , such as for provision of oxygen to a patient through the CSA. The lateral openings  24 ,  26  can be arranged such that one prong  28  is received by the lateral opening  24  and the second prong  28  is received by the midline opening  22  (as depicted in  FIG. 1 ) or the lateral openings  24 ,  26  might be arranged to each receive a prong  28 . The lateral openings  24 ,  26  may also be configured to receive a variety of other apparatus including catheters, cannula, and other equipment that might be employed during a procedure on a patient. The lateral openings  24 ,  26  may be dimensioned to receive the prong  28  of the nasal cannula  30  and/or any other apparatus in a friction-fit arrangement to assist retention of the prong  28  or other apparatus in the openings  24 ,  26 . Or the prong  28  and/or other apparatus can be loosely or glidingly received therein. 
         [0023]    The superior plate  18  and the inferior plate  20  extend along the superior or upper surface and the inferior or lower surface of the central portion  16  of the internal body  12 , respectively. Both plates  18 ,  20  include a projection  32 ,  34  respectively that extends beyond a distal end of the central portion  16  a distance and curves or angles downwardly or inferiorly. The length of the plates  18 ,  20  is limited such that the plates  18 ,  20  do not extend into the posterior oropharynx  35 . As such, the conscious patient  17  can tolerate the CSA without triggering the patient&#39;s gag reflex. 
         [0024]    The plates  18 ,  20  may be coupled to the central portion  16  or may be integral therewith. In an embodiment, the plates  18 ,  20  are integrated into and form top and bottom surfaces of the central portion  16  and the superior and inferior projections  32 ,  34  extend from a distal end of the central portion  16 . The plates  18 ,  20  in combination with the central portion  16  form a bite block that protects apparatus, such as an endoscope, inserted through one or more of the openings  22 ,  24 ,  26  from being bitten and/or damaged by the patient. 
         [0025]    The downward curvature of the superior projection  32  on the superior plate  28  aids directing of apparatus inserted into one or more of the openings  22 ,  24 ,  26  toward the posterior oropharynx  35  as depicted in  FIG. 7 . For example, an endoscope  52  inserted through the midline opening  16  may contact the superior projection  32  and follow along a bottom surface thereof to be diverted toward the posterior oropharynx  35 . 
         [0026]    The inferior projection  34  assists maintaining the patient&#39;s tongue  37  in a forward anterior position. The inferior projection  34  curves downwardly into contact with the patient&#39;s tongue  37  to engage a surface thereof. The engagement with the tongue  37  resists the tongue  37  falling toward the posterior oropharynx  35  when the patient  17  is laid on their back and/or when the patient  17  is sedated and/or rendered unconscious. 
         [0027]    The anterior flange  14  is configured to remain outside of the mouth  15  of the patient and to overlie the upper and lower lips of the patient to resist or prevent swallowing or inhalation of the CSA  10  by the patient. As depicted in  FIG. 2 , the anterior flange  14  includes a superior portion  36 , an inferior portion  38 , and a pair of lateral portions  40 , but the anterior flange  14  may be configured as desired for a particular application without departing from the scope of embodiments of the invention described herein. The superior portion  36  extends a sufficient distance to at least partially overlie the patient&#39;s upper lip or jaw and the inferior portion  38  extends a sufficient distance to at least partially overlie the patient&#39;s lower lip or jaw. The lateral portions  40  include one or more apertures  42  configured to receive a strap  44 . The strap  44  extends around the patient&#39;s head to maintain the CSA  10  in position in the patient&#39;s mouth  15  during sedation. The strap  44  may include elastic, rubber, or other resilient band, cord, strap, or other apparatus suitable for maintaining the position of the CSA  10 . 
         [0028]    With additional reference now to  FIGS. 5-7 , use of the CSA  10  in the patient  17  is described in accordance with an embodiment of the invention. As depicted in  FIG. 5 , the CSA  10  can be inserted into the mouth  15  of a patient  17  while the patient is conscious or after partial or full sedation. The superior and inferior portions  36 ,  38  of the anterior flange  14  rest on the lips of the patient  17 . The anterior flange  14  thus prevents the patient  17  from swallowing the CSA  10 . The internal body  12  rests between the upper and lower portion of the patients mouth  15 . The internal body  12  can thus function as a bite block and to maintain a patent airway. The distance from the anterior flange  14  to the distal end of the internal body  12  is shorter than known airways used in the art and enables the conscious patient  17  to tolerate the CSA  10  without triggering the gag reflex. The inferior plate  20  and the inferior projection  34  thereof resists or prevents the tongue  37  from falling into the posterior oropharynx  35 . 
         [0029]    An NPA  46  can be inserted through the midline opening  22 , for example, when the patient becomes obstructed and the provider needs another modality to maintain a patent airway, as depicted in  FIG. 6 . The NPA  46  extends beyond the internal body  12  into the posterior oropharynx  35 . The midline opening  22  has a diameter smaller than that of the flange  50  of the NPA  46  to obstruct passage of the flange  50  through the midline opening  22 . Swallowing and or aspiration of the NPA  46  are thus prevented. 
         [0030]    As shown in  FIG. 7 , an endoscope  52  may be inserted through the midline opening  22  of the CSA  10 . As described previously, the internal body  12  of the CSA  10  functions as a bite block to prevent the patient  17  from biting and/or damaging the endoscope  52  while inserted in the midline opening  22 . During insertion of the endoscope  52  through the CSA  10 , the superior projection  32  on the superior plate  18  may aid to guide the endoscope  52  toward the posterior oropharynx  35 . As such, contact with the soft palate and other upper portions of the mouth  15  of the patient  17  that may cause harm or irradiation thereof may be reduced or avoided. 
         [0031]    Many different arrangements of the various components depicted, as well as components not shown, are possible without departing from the scope of the claims below. Identification of structures as being configured to perform a particular function in this disclosure and in the claims below is intended to demarcate those structures as including a plurality of possible arrangements or designs within the scope of this disclosure and readily identifiable by one of skill in the art to perform the particular function in a similar way without specifically listing all such arrangements or designs. Embodiments of the technology have been described with the intent to be illustrative rather than restrictive. Alternative embodiments will become apparent to readers of this disclosure after and because of reading it. Alternative means of implementing the aforementioned can be completed without departing from the scope of the claims below. Certain features and subcombinations are of utility and may be employed without reference to other features and subcombinations and are contemplated within the scope of the claims.