Abstract:
An enhanced airway for creating an airway in a patient including a rigid connector with an insertion portion inserted into a flexible tube, and a padding member surrounding the flexible tube and the inserted portion of the rigid connector. The rigid connector includes a circuit end that may be directly coupled to an anesthesia circuit, reducing risk of fire caused by diffusing oxygen. The circuit end may also be covered by an oxygen mask or left open and uncoupled. The flexible tube enables a comfortable and less-injury prone creation of an airway in the patient&#39;s oral cavity. The rigid connector prevents a patient from biting down and collapsing the flexible tube and, if also inserted in the patient&#39;s airway, an endotracheal tube or a laryngeal mask airway. The padding member cushions the rigid connector, preventing damage and injury to a patient&#39;s teeth upon biting the rigid connector.

Description:
RELATED APPLICATIONS 
     This patent application claims priority to U.S. Provisional Patent Application Ser. No. 61/370,695, filed Aug. 4, 2010, the entire contents of which are herein incorporated by reference. 
    
    
     FIELD OF INVENTION 
     Embodiments of the invention are directed to devices and related methods used to create airways in patients. 
     BACKGROUND 
     An oropharyngeal airway (OPA), also referred to as an oral airway, is used to create an air passageway between the mouth and the posterior pharyngeal wall of a patient. Unconscious patients (e.g., under general anesthesia) and heavily sedated semi-unconscious patients (e.g., under monitored anesthesia care (MAC)) may have an oral airway inserted to relieve an obstructed airflow. 
     Prior art oral airways include a hard curved piece of plastic that is often poorly tolerated in conscious and semi-conscious patients. For instance, these 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 can develop in the mouth and bleeding 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 glottis and cut off an air supply. A rigid oral airway that is too small can cause tongue sores and swelling. 
     Endotracheal tubes (ETT) are flexible and inserted beyond the vocal cords into the trachea, which is further into the oral passageway than an oral airway. ETTs are somewhat flexible and compressible and include an inflatable portion which causes a seal in the airway and secures the ETT in place. The flexible and compressible nature of an ETT enables a patient to collapse the ETT by biting, which can cut off an air supply and lead to pulmonary edema. 
     Nasopharyngeal airways, also referred to as nasal airways, are also used to alleviate airway obstructions, but create an air passageway between the nose and posterior pharyngeal wall of a patient. Nasal airways may also cause discomfort and injury to a patient. For instance, nasal airways may cause nosebleeds and local nasal discomfort. 
     SUMMARY 
     In one embodiment, the invention provides an enhanced airway apparatus. The enhanced airway includes a tubular member made of a flexible thermoplastic elastomer material (e.g., mediprene) and including a first inner diameter. The tubular member includes a first end and a beveled end. The enhanced airway further includes a connector and a padding member with a tubular shape. The connector includes an insertion portion with a first diameter and a connecting portion. The first end of the tubular member is received by the padding member to form a padded tubular portion and the padded tubular portion receives the insertion portion of the connector. The connecting portion has a larger diameter than the first diameter and is configured to be coupled to an anesthesia breathing circuit. The connector insertion portion is generally sized to extend beyond the patient&#39;s incisors and the tubular member is generally sized to extend into the oral cavity, but not beyond the epiglottis of the patient. In some embodiments, the connector is rigid such that the connector prevents collapse of the enhanced airway due to patient biting. 
     In another embodiment, the invention provides a method of creating an airway in a patient by inserting an enhanced airway apparatus as described above into a patient&#39;s nasal or oral cavity. Additionally, in some embodiments, after insertion of the enhanced airway into the patient, the method further includes 1) placing an oxygen mask over the patient&#39;s nose and mouth and the connecting portion, 2) coupling an anesthesia breathing circuit to the connecting portion, or 3) inserting an ETT or laryngeal mask airway (LMA) alongside the inserted enhanced airway, the connector insertion portion preventing the collapse of the enhanced airway, ETT, and/or LMA due to patient biting. 
     Other aspects of the invention will become apparent by consideration of the detailed description and accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1A and 1B  depict a top view and side view of an enhanced airway, respectively. 
         FIG. 2  depicts another top view of the enhanced airway. 
         FIG. 3  depicts an exploded view of the enhanced airway. 
         FIGS. 4A-C  depict the beveled end of the insertion end of the enhanced airway tube. 
         FIG. 5  depicts a connector receiving end of the enhanced airway tube. 
         FIG. 6  depicts one end of a gel wrap that is placed over the connector receiving end of the enhanced airway tube. 
         FIG. 7  depicts a circuit end of the connector that may be coupled to an external anesthesia device. 
         FIG. 8  depicts the insertion end of the connector that is inserted into the connector receiving end of the enhanced airway tube. 
         FIG. 9A  depicts a cross section of the enhanced airway along line A of  FIG. 2 . 
         FIG. 9B  depicts a cross section of the enhanced airway along line B of  FIG. 2 . 
         FIG. 10  depicts the enhanced airway positioned in the pharynx of a patient. 
         FIG. 11  depicts the enhanced airway coupled to an anesthesia circuit. 
         FIG. 12  depicts the enhanced airway in use with an oxygen mask. 
         FIGS. 13A-B  depict the enhanced airway in use with an LMA. 
         FIGS. 14A-B  depict the enhanced airway in use with an ETT. 
     
    
    
     DETAILED DESCRIPTION 
     Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. 
       FIGS. 1A-B ,  2 , and  3  depict an enhanced airway  100  according to embodiments of the invention. The enhanced airway  100  includes a connector  105 , a wrap  110 , and a tube  115 , which form an airway  117 . The connector  105  is a rigid, generally inflexible body with a circuit end  120 , a separation plate  125 , and an insertion end  130 . The insertion end  130  is hidden by the wrap  110  in  FIGS. 1A-1B . The connector  105  is, for instance, made of a hard plastic material such as polyethylene. The circuit end  120  has an approximately 15 mm outer diameter and is operable to be directly coupled to an anesthesia circuit and an ambu bag (see, e.g.,  FIGS. 11 and 12 , respectively). In some uses, however, the circuit end  120  is not directly coupled to an anesthesia circuit or an ambu bag, but, rather, is used with an oxygen mask that covers the patient&#39;s mouth, nose, and the circuit end  120  (see, e.g.,  FIG. 13 ). An oxygen mask is of particular use for semi-conscious patients, although the oxygen mask is also used in other patient scenarios. 
     The tube  115  is a flexible and compressible tube made of, for instance, a latex free, soft thermoplastic elastomer, such as mediprene. The insertion end  130  of the connector  105  is received by a connector receiving end  135  of the tube  115 . The insertion end  130  of the connector  105  and the connector receiving end  135  of tube  115  are friction fitted such that, once inserted, the connector  105  is secured within the tube  115  by friction. The friction forces are increased by the elastic forces of the tube  115  compressing inward onto the insertion end  130  of the connector  105 . The outer diameter of the insertion end  130  is approximately equal to or slightly greater than the inner diameter of the tube  115  to ensure a snug fit. As depicted in  FIGS. 4A-C , the insertion end  140  of the tube  115  includes a beveled tip for comfort and gentle insertion into a patient&#39;s airway. The connector receiving end  135  of the tube  115  has a flat, non-beveled tip, as depicted in  FIG. 5 . The connector receiving end  135  is pushed onto the insertion end  130  of the connector  105 . In some instances, the connector receiving end  135  is pushed onto the insertion end  130  of the connector  105  until reaching the separation plate  125 . In some embodiments, the connector receiving end  135  flares out (a “trumpet style”) to ease insertion of the insertion end  130  of the connector  105  into the tube  115 . 
     The wrap  110  is positioned around the tube  115  (i.e., the tube  115  is inserted into the wrap  110 ). The wrap  110  is made of a soft material to provide cushioning or padding for the rigid connector  105 . The cushioning prevents harm to teeth of a patient that bites on the enhanced airway  100 . The wrap is made of a gel-like nylon material and is sized to fit tightly onto the tube  115  to prevent slippage. In some embodiments with a flared connector receiving end  135 , the wrap  110  also includes a flared end. In other embodiments with a flared connector receiving end  135 , the wrap  110  is reduced in size so as not to cover the flared portion of the tube  115 . In some embodiments, the wrap  110  is sized to fit tightly over the connector  105 , and the connector  105  fits tightly over the tube  115 . 
     Cross sections of the enhanced airway  100  are depicted in  FIGS. 9A and 9B , which illustrates that the airway  117  is surrounded first by the insertion end  130  of the connector  105 , then the tube  115 , and finally the wrap  110 . 
     The tube  115  is designed in several sizes to accommodate the various pharynx sizes of patients. Below is an exemplary size chart for the tube  115  and connector  105  based on estimated pharynx sizes by patient age. The size, length and diameter of the enhanced airway  100  are merely exemplary and should not be interpreted as limiting. 
     
       
         
               
               
               
               
               
               
             
               
               
               
               
               
               
             
           
               
                   
               
               
                   
                   
                   
                   
                   
                 Insertion  
               
               
                   
                   
                 Tube 
                 Tube 
                 Total 
                 End 130 
               
               
                   
                 Tube 
                 115 
                 115  
                 Connector 
                 Length (of  
               
               
                   
                 115 
                 Internal 
                 External 
                 105  
                 Connector 
               
               
                 Patient 
                 Length 
                 Diameter 
                 Diameter 
                 Length 
                 105) 
               
               
                 Age 
                 (mm) 
                 (mm) 
                 (mm) 
                 (mm) 
                 (mm) 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 0-6 mo 
                 70 
                 3.2 
                 6.7 
                 34 
                 22 
               
               
                 6 mo-1 yr 
                 80 
                 3.9 
                 7.4 
                 35 
                 22 
               
               
                 1-4 yr 
                 90 
                 4.5 
                 8.0 
                 36 
                 24 
               
               
                 5-8 yr 
                 100 
                 5.2 
                 8.7 
                 36 
                 24 
               
               
                 8-10 yr 
                 110 
                 5.9 
                 9.4 
                 38 
                 28 
               
               
                 Adult 
                 130 
                 6.5 
                 10 
                 40 
                 30 
               
               
                 female 
                   
                   
                   
                   
                   
               
               
                 Adult 
                 150 
                 7.4 
                 10.7 
                 40 
                 30 
               
               
                 large male 
               
               
                   
               
             
          
         
       
     
       FIG. 10  depicts the enhanced airway  100  inserted into the pharynx of a patient  200 . In contrast to an LMA and ETT (see, e.g.,  FIGS. 13A and 14A , respectively), the enhanced airway does not extend beyond the epiglottis  205  of the patient. The separation plate  125  prevents the enhanced airway from entering the oral cavity and provides a surface to ensure that the insertion end  130  of the connector  105  is not over-extended into the tube  115 . 
     Generally, the enhanced airway  100  is provided to health care facilities fully assembled (e.g., as in  FIG. 1 ) and is individually wrapped to be a single use (i.e., disposable) device. A medical practitioner determines the properly sized enhanced airway  100  for the patient  200 , removes the enhanced airway  100  from its packaging, and inserts the enhanced airway  100  into a patient  200 . The inserted enhanced airway  100  forms an airway from the mouth to just before the epiglottis  205  (in the vallecula) of the patient  200 . In some embodiments, the circuit end  120  is coupled to an anesthesia circuit as illustrated in  FIG. 11 . 
     The increased flexibility, reduced diameter, and increased length of the enhanced airway  100  each provide benefits over traditional oral airways. The tube  115  of the enhanced airway  100  is softer and more flexible than traditional oral airways, which eliminates the issues associated therewith. For instance, the tube  115  will reduce gagging, vomiting, aspiration, laryngospasm, and damage to teeth relative to the traditional oral airway. Furthermore, choosing the appropriate size of the enhanced airway  100  is easier than traditional oral airways as improper sizing of the enhanced airway  100  has less potential to harm a patient by, e.g., closing the glottis and causing tongue sores, swelling, and bleeding. Additionally, the enhanced airway  100  is easier to insert, as the flexibility prevents pushing the tongue backward, which can block the airway. Unlike the traditional oral airway, the enhanced airway  100  may be inserted without the use of a tongue depressor and without the need to rotate the device 180 degrees before passing over the tongue, thus simplifying insertion. The use of a rigid connector  105  within the flexible tube  115  prevents a patient from biting down and closing off the airway  117 . The wrap  110  provides cushioning to prevent a patient that bites on the connector  105  from harming his or her teeth. Both the wrap  110  and insertion end  130  of the connector  105  are generally sized to extend beyond the incisors of the patient  200 . 
     The enhanced airway  100  also reduces safety issues related to the use of oxygen generating devices in connection with oral airways. When medical oxygen is used for a patient, a potential fire hazard is created by the flammable oxygen diffusing in the environment near the patient. Traditional oral airways are an open system and cannot be directly coupled to a circuit (e.g., an oxygen generating anesthesia circuit). Therefore, certain procedures with instruments that pose a fire/spark risk (e.g., procedures including cautery), particularly near a patient&#39;s face, pose a fire hazard for the patient and the staff when using a traditional oral airway. The enhanced airway  100  is directly coupled to a circuit, which diminishes oxygen diffusion and the associated fire hazard in the area near the patient&#39;s face. The circuit also allows for medical air to be administered, decreasing FiO2 (oxygen concentration) to safe levels. This decrease results in increased safety for both the patient  200  and medical staff. Furthermore, a circuit is operable to measure FiO2 and, therefore, the use of a circuit with the enhanced airway  100  enables more accurate measuring of FiO2 at the oxygen source. Measuring FiO2 at the source allows safety issues to be more accurately assessed and controlled to various levels. Additionally, use of the circuit with the enhanced airway  100  enables safe delivery of a higher concentration and/or higher amount of oxygen to the patient  200  than otherwise possible (e.g., up to a 100% level FiO2). 
     The enhanced airway  100  is usable in various medical situations, including during MAC (patient is semi-conscious), sedation-free situations, and general anesthesia (patient is unconscious). For instance, during MAC, the enhanced airway  100  may be coupled to an anesthesia circuit (see  FIG. 11 ), used with an oxygen mask (not directly coupled) (see  FIG. 12 ), or not coupled to another device ( FIG. 10 ). 
       FIG. 11  depicts the enhanced airway  100  coupled via connector  105  to an anesthesia circuit  250 . The anesthesia circuit  250  includes a circuit connector  255  with three openings: a first opening  260  for coupling the circuit connector  255  to a vital signs monitor  262 ; a second opening  265  for coupling to the circuit end  120 ; and a third opening  270  for coupling to a Y-connector  275 . The vital signs monitor  262  is coupled to the first opening  260  via a sensor tube  263 , which enables sensors  264  to monitor the FiO 2  and end-tidal carbon dioxide (ETCO 2 ) levels in the airflow through the circuit connector  255 . The vital signs monitor  262  is operable to generate alerts by comparing measured FiO 2  and ETCO 2  levels to stored thresholds (e.g., thresholds stored in a memory). The Y-connector  275  is coupled to a first circuit tube  280  and a second circuit tube  285 . The first and second circuit tubes  280  and  285  are coupled to the anesthesia machine  290 . The particular anesthesia circuit  250  is merely exemplary as other types of anesthesia circuits may also be coupled to the circuit end  120 . 
       FIG. 12  depicts the enhanced airway  100  in use with oxygen mask  300 . The mask  300  is placed over the mouth of the patient  200  and the circuit end  120  of the inserted enhanced airway  100 . The mask includes an airflow tube  305  that is coupled to, for example, an oxygen supply (not shown), and provides bidirectional airflow. 
     As shown in  FIG. 10 , the enhanced airway  100  may also be inserted to create an airway in a patient  200  without coupling the circuit end  120  to another device. For example, the enhanced airway  100  is usable in sedation-free situations and emergencies, such as while a patient is receiving cardiopulmonary resuscitation (CPR), without connecting the circuit end  120  to an anesthesia circuit. 
     During general anesthesia, an ETT or LMA may be inserted into the patient&#39;s airway for supplying oxygen to the patient and to assist in ventilating the patient.  FIG. 13A  depicts an LMA  315  inserted into patient  200 . The LMA  315  includes an end connector  320 , which may be coupled to an anesthesia circuit, such as anesthesia circuit  250  described above. In  FIG. 13B , the enhanced airway  100  is shown inserted alongside the smaller diameter LMA  315 . The rigid connector  105  of the enhanced airway  100  prevents the collapse of the LMA  315  from biting by the patient  200 . Additionally, the separation plate  125  prevents the enhanced airway  100  from sliding into the patient&#39;s oral cavity. As the enhanced airway  100  is positioned within the oral cavity, the tube  115  provides additional stability to prevent movement of the rigid connector  115  within or out of the bite zone of the patient  200 . 
       FIG. 14A  depicts an ETT  325  inserted into the patient  200 . The ETT  325  includes an end connector  330  and air port  335 . The end connector  330  may be coupled to an anesthesia circuit, such as anesthesia circuit  250  described above. The air port  335  is used to supply air to inflate a pilot cuff  340  to seal the airflow through the trachea of patient  200  and ensure the ETT  325  stays in the proper position. For removal of the ETT  325 , the pilot cuff  340  is deflated via air port  335 . In  FIG. 14B , the enhanced airway  100  is shown inserted alongside the smaller diameter ETT  325 . The rigid connector  105  of the enhanced airway  100  prevents the collapse of the ETT  325  from biting by the patient  200 . Additionally, the separation plate  125  prevents the enhanced airway  100  from sliding into the patient&#39;s oral cavity. As the enhanced airway  100  is positioned within the oral cavity, the tube  115  provides additional stability to prevent movement of the rigid connector  115  within or out of the bite zone of the patient  200 . 
     In some embodiments, the enhanced airway  100  provides direct access to patient secretions in the upper airway of patients. A flexible suction catheter is inserted through the enhanced airway  100  (through airway  117 ) to reach the secretions. Suction forces are applied to the non-inserted end of the flexible suction catheter to suction and remove secretions of the patient. Secretion suction enables removal of secretions in the upper airway of patients, which is particularly beneficial for those patients unable to cough and/or clear their own secretions effectively. The enhanced airway  100  reduces the trauma caused to the oral muscosa by a flexible suction catheter that would otherwise be present without the use of the enhanced airway. 
     In some embodiments, the enhanced airway  100  is inserted into the nasal cavity of the patient  200  to create an airway. In some instances, the enhanced airway  100  is used eliminate obstructions in the upper airway, such as caused by sleep apnea. Additionally, the enhanced airway  100  will reduce or eliminate snoring when worn by a sleeping patient. In some embodiments, the enhanced airway  100  is used to create airways in animals in veterinary applications. 
     Thus, the invention provides, among other things, an enhanced airway to provide a safe, comfortable airway in a patient. Various features and advantages of the invention are set forth in the following claims.