Patent Publication Number: US-2015068538-A1

Title: Oral Airway and Intubation Assisting Device

Description:
This application claims priority to provisional application Ser. No. 61/875,717 filed Sep. 10, 2013 to the extent allowed by law, and to provisional application Ser. No. 61/982,348 filed Apr. 22, 2014 to the extent allowed by law. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates generally to the technical field of medical devices, and more particularly, to the technical field of oral airway and intubation assisting devices. 
     2. Description of the Prior Art 
     During surgeries and emergency medical situations, a doctor, nurse, or medical technician will often place a tube into a patient&#39;s trachea. The tube stabilizes the patient&#39;s airway, providing an unobstructed passage for air or other gases to the patient&#39;s lungs. 
     The process of placing the tube into a patient&#39;s trachea is called intubation. As typically carried out, the patient lies face up and the medical practitioner stands at the patient&#39;s head and uses their right hand to open the patient&#39;s mouth. The medical practitioner holds a device called a laryngoscope in their left hand. The laryngoscope includes a cylindrical handle attached perpendicularly to a curved metal blade, the arc of which approximates the curve of the patient&#39;s throat. By seating this blade against the patient&#39;s tongue and lower throat and lifting the tongue and lower throat forward and upward, the medical practitioner can create a straight line of sight into the patient&#39;s larynx. With this view, the medical practitioner uses their right hand to thread the intubation tube between the patient&#39;s vocal chords and into the trachea. The medical practitioner seats the tube in the person&#39;s trachea and withdraws the laryngoscope. Often, the practitioner will secure the tube against further movement with tape or a fixture device. 
     Before the intubation tube establishes a clear airway to the patient&#39;s lungs, the patient breathes with a mask that seals to their face. However, without an intubation tube in place, the patient&#39;s airway may be obstructed by the patient&#39;s tongue and tissues. To remedy this situation, a short tube called an oropharyngeal airway is placed in the patient&#39;s mouth. The oropharyngeal airway provides a passageway for air to the larynx, but not beyond. The oropharyngeal airway takes up a great deal of room in the patient&#39;s mouth and must be removed before beginning the intubation process. If the medical practitioner cannot seat the intubation tube in the patient&#39;s trachea, they will remove the laryngoscope and replace the oropharyngeal airway to establish breathing and then attempt intubation again. 
     Sometimes a medical practitioner will use the patient&#39;s upper teeth as a fulcrum for the laryngoscope blade, levering the patient&#39;s tongue and throat upward. While this method is incorrect, it is used occasionally and places large forces on the upper teeth, sometimes chipping or breaking the patient&#39;s upper teeth. The patient can inhale pieces of teeth, causing further complications. Additionally, the patient&#39;s upper lip may slip between their teeth and the laryngoscope blade causing the patient&#39;s lip to be cut or bruised. 
     U.S. Pat. No. 8,104,467 discloses a rapid orotracheal intubation guide that facilitates orotracheal intubation or direct orotracheal visualization without resting the device on the patient&#39;s tongue. During bronchoscopic intubation, the device automatically ejects the endotracheal tube from the device as the endotracheal tube is advanced coaxially over a bronchoscope previously placed through the guide. The device in patent &#39;467 does not work with a traditional laryngoscope and must be removed in order to use the laryngoscope. The device in patent &#39;467 also does not include external tube fixation and does not include force redirection from the patient&#39;s incisors to the mandible, because the device simply covers the patient&#39;s teeth. 
     U.S. Patent Application Publication 2007/0197876 discloses a dental guard for airway intubation that includes an upper mouth guard for the maxillary teeth attached to blocks or wedges for keeping the jaw open. Once intubation has been accomplished and the laryngoscope has been removed, the dental guard may be removed, may remain in the patient&#39;s jaw as a bite block, or may be replaced with another type of bite block. However, the dental guard in publication &#39;876 does not allow access to the right side of the patient&#39;s mouth and impedes the use of a traditional laryngoscope. 
     U.S. Pat. No. 7,866,313 discloses an oral airway that facilitates tracheal intubation that includes a first component having a first guiding surface and a second component having a second guiding surface. The first component and the second component are removably coupled together such that the first guiding surface and the second guiding surface together define an interior passage through the oral airway that is dimensioned to direct a fiber-optic scope or an endotracheal tube extending through the interior passage for tracheal intubation. The first component and second component can then be decoupled for independent removal from the patient&#39;s mouth, without disrupting the endotracheal tube. The oral airway of patent &#39;313 holds the patient&#39;s tongue back, however, it comprises two separate pieces and does not allow for the use of a laryngoscope. 
     The prior art to date does not disclose an oral airway and intubation assisting device that can be used with a laryngoscope, protects the patient&#39;s upper teeth, distributes force from the patient&#39;s incisor teeth to the mandible bone, holds the patient&#39;s mouth open, and maintains the patient&#39;s tongue up and to the side to maintain a clean airway. None of the prior art can be combined in a way to suggest these necessary modifications. There is no teaching, suggestion, or motivation that would have enabled a person of ordinary skill in the art to modify any prior art oral airway and intubation assisting device to arrive at the present invention. 
     It is a primary object of the present invention to provide an oral airway and intubation assisting device that holds the patient&#39;s mouth open to free up the medical practitioner&#39;s hand and to aid in visualization of the larynx. 
     Another object of the present invention is to provide an oral airway and intubation assisting device that maintains a clear airway by moving the patient&#39;s tongue up and to one side of the mouth. 
     Still another object of the present invention is to provide an oral airway and intubation assisting device that protects a patient&#39;s teeth from impact, force, or other damage by a laryngoscope or other oral devices. 
     Still another object of the present invention is to provide an oral airway and intubation assisting device that includes a wedge across the patient&#39;s teeth that prevents tooth damage by redirecting the force applied by the laryngoscope from the incisor teeth to the mandible bone. 
     Still another object of the present invention is to provide an oral airway and intubation assisting device that includes a wedge that holds the patient&#39;s lips away from the laryngoscope and its pinch points. 
     Still another object of the present invention is to provide an oral airway and intubation assisting device that keeps the patient&#39;s mouth unobstructed, thereby allowing concurrent use with a traditional laryngoscope without having to remove the device. 
     Still another object of the present invention is to provide an oral airway and intubation assisting device that can be left in the patient&#39;s mouth to prevent the patient from biting down on the tube. 
     Still another object of the present invention is to provide an oral airway and intubation assisting device that includes a clip to hold the endotracheal tube without having to tape the tube to the patient&#39;s face. 
     SUMMARY OF THE INVENTION 
     The oral airway and intubation assisting device of the present invention comprises a mouth guard to assist in the intubation that provides an airway passage and mouth opening wedge. The mouth guard comprises at least one member adapted to protect the patient&#39;s teeth, at least one block adapted to maintain the patient&#39;s mouth open, and at least one airway guide adapted to allow air to flow past the patient&#39;s tongue. The wedge protects the patient&#39;s teeth from the high force loads imposed by a laryngoscope and redirects those forces to the patient&#39;s maxilla, the upper jaw bone structure. The wedge also keeps the patient&#39;s lip clear of the upper teeth. Additionally, the mouth guard may include a tube retainer that secures the intubation tube in the patient&#39;s mouth. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present invention is further described with reference to the accompanying drawings in which: 
         FIG. 1  is a top perspective view of a first embodiment of the oral airway and intubation assisting device of the present invention that includes a first embodiment of a tube retainer. 
         FIG. 2  is a front perspective view of the first embodiment of the oral airway and intubation assisting device of the present invention that includes the first embodiment of the tube retainer. 
         FIG. 3  is a front perspective view of a second embodiment of the oral airway and intubation assisting device of the present invention. 
         FIG. 4  is a front plan view of a third embodiment of the oral airway and intubation assisting device of the present invention. 
         FIG. 5  is a top plan view of the third embodiment of the oral airway and intubation assisting device of the present invention. 
         FIG. 6  is a top perspective view of a fourth embodiment of the oral airway and intubation assisting device of the present invention that includes a second embodiment of a tube retainer. 
         FIG. 7  is a top perspective view of a fifth embodiment of the oral airway and intubation assisting device of the present invention that includes a third embodiment of a tube retainer. 
         FIG. 8  is a top perspective view of the fifth embodiment of the oral airway and intubation assisting device of the present invention that includes a fourth embodiment of a tube retainer. 
         FIG. 9  is a top perspective view of the fourth embodiment of the oral airway and intubation assisting device of the present invention that includes a fifth embodiment of a tube retainer. 
         FIG. 10  is a top perspective view of the fourth embodiment of the oral airway and intubation assisting device of the present invention that includes the fifth embodiment of the tube retainer with an intubation tube in place. 
         FIG. 11  is a top perspective view of the fifth embodiment of the oral airway and intubation assisting device of the present invention that includes a sixth embodiment of a tube retainer. 
         FIG. 12  is a top perspective view of the fifth embodiment of the oral airway and intubation assisting device of the present invention that includes the sixth embodiment of the tube retainer twisted into a serpentine structure. 
     
    
    
     DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS 
     As illustrated in  FIGS. 1 and 2  the oral airway and intubation assisting device of a first embodiment of the present invention comprises a mouth guard  10  having a block section  12  connecting a first curved member  14  and a second curved member  16 . Each of the curved members  14 ,  16  is attached to the block section  12 . A first embodiment of a tube retainer  18  is attached to the block section  12 . An airway maintenance guide  20  is integrated into the block section  12 . 
     In this broad embodiment, the present invention includes at least one member  14 ,  16  shaped to protect the teeth, connected to at least one block  12 . The members  14 ,  16  that protect the teeth are shaped such that the forces applied to the teeth are redirected to the maxilla. Attached to the block  12  or the members  14 ,  16  shaped to protect the teeth is a portion  20  that allows air past the tongue. Additionally, the embodiment may include a tube retainer  18  to retain the intubation tube. 
     In further detail, still referring to the first embodiment shown in  FIGS. 1 and 2 , the airway maintenance guide  20  is sufficiently wide for the free passage of air, such as about three-eighths of an inch wide. The first curved member  14  and second curved member  16  are sufficiently long enough to cover at least the incisors, such as about one inch long. The tube retainer  18  is sufficiently thin to allow it to flex out of the way of the laryngoscope, such as about one-eighth inch wide, and is sufficiently long enough, such as about two inches long, to project out of the patient&#39;s mouth. The mouth guard  10  can be manufactured in a variety of sizes to accommodate different sized patients. 
     Referring to  FIG. 3 , a second embodiment of the present invention comprises a mouth guard  40  having a single block section  42  connected to a single curved member  44  to provide protection to only one set of teeth and leave more free space in the patient&#39;s mouth. An airway maintenance guide  46  is integrated into the block section  42 . The broad, second embodiment of the present invention includes at least one member  44  shaped to protect the teeth, connected to at least one block section  42 . The block section  42  may include an airway maintenance guide  46  through the mouth, or other features that allow air past the tongue. The second embodiment of the present invention may include a feature to retain the intubation tube. 
     A broad, third embodiment of the present invention, shown in  FIGS. 4 and 5 , comprises a mouth guard  50  having a block section  52  connecting a single curved member  54  and a support member  56  that maintain the patient&#39;s mouth open. The single curved member  54  is sufficiently long enough to cover at least the patient&#39;s incisor teeth with a tray profile shaped to secure the single curved member  54  to the patient&#39;s upper teeth. The single curved member  54  includes a wedge  60  along its front face. The wedge  60  projects from the front face of the single curved member  54  far enough to displace the patient&#39;s upper lips upward and redirect the force of the laryngoscope to the patient&#39;s maxilla. The support member  56  is long enough to locate the mouth guard  50  to the patient&#39;s lower teeth with a tray profile to secure the support member  56  to the patient&#39;s lower teeth. The mouth guard  50  can be manufactured in a variety of sizes to accommodate differently sized patients. 
     An airway maintenance guide  58  is connected to at least one of the block section  52  and the support member  56  and includes a clear cross-sectional area that is sufficiently wide for the free passage of air. The airway maintenance guide  58  curves to follow the contour of a patient&#39;s throat, with a profile shaped to push the patient&#39;s tongue to the left. The airway maintenance guide  58  is located sufficiently far from the single curved member  54  so that the patient&#39;s mouth is clear for the insertion and placement of the laryngoscope. The third embodiment of the present invention may include a feature to retain the intubation tube. 
     As illustrated in  FIG. 6 , a fourth embodiment of the present invention comprises mouth guard  62  having a block section  64  connecting a single curved member  66  and a support member  68 . The single curved member  66  and the support member  68  are attached to the block section  64 . An airway maintenance guide  70  is connected to the block section  64  and the support member  68 . A second embodiment of a tube retainer  72  is attached to the single curved member  66 . 
     In further detail, still referring to the embodiment of  FIG. 6 , the airway maintenance guide  70  includes a clear cross-sectional area that is sufficiently wide for the free passage of air. The airway maintenance guide  70  curves to follow the contour of a patient&#39;s throat, with a profile shaped to push the patient&#39;s tongue to the left. The airway maintenance guide  70  is located sufficiently far from the single curved member  66  so that the patient&#39;s mouth is clear for the laryngoscope. The tube retainer  72  comprises a long thin member  74 , with at least one enlarged area  76  and an aperture  78 . The long thin member  74  is small enough in cross-section that it is flexible and the enlarged areas  76  are of sufficient size to pass through the wide portion  80  of the aperture  78  yet catch in the thin portion  82  of the aperture  78  when member  74  is looped around and the top end of member  74  is inserted into aperture  78 . 
     Referring again to  FIG. 6 , the single member  66  is sufficiently long enough to cover at least the patient&#39;s incisor teeth with a tray profile shaped to secure the single curved member  66  to the patient&#39;s upper teeth. The single curved member  66  includes a wedge  84  along its front face. The wedge  84  projects from the front face of the single curved member  66  far enough to displace the patient&#39;s upper lips upward and redirect the force of the laryngoscope to the patient&#39;s maxilla. The support member  68  is long enough to locate the mouth guard  62  to the patient&#39;s lower teeth with a tray profile to secure the support member  62  to the patient&#39;s lower teeth. The mouth guard  10  can be manufactured in a variety of sizes to accommodate differently sized patients. 
     Referring to  FIG. 7 , a fifth embodiment of the present invention comprises mouth guard  86  having a first block section  88  connecting a larger first curved member  90  and a smaller second curved member  92 . Additionally, a second block section  94  connects the larger first curved member  90  to a smaller third curved member  96 . An airway maintenance guide  98  is attached to the first block section  88  and the second curved member  92 . A third embodiment of a tube retainer  100  is connected to the first curved member  90 . 
     In further detail, still referring to the fifth embodiment shown in  FIG. 7 , the second block section  94  and third curved member  96  provide additional engagement with the patient&#39;s lower teeth. The tube retainer  100  includes at least one hook  102  and is sufficiently thin so as to be flexible. The hook  102  has a diameter matching the thickness of the tube retainer  100  so that the hook  102  catches on and holds the tube retainer  100 . 
     The various embodiments of the present invention can include various embodiments of the tube retainer. A first embodiment of the tube retainer  18  was shown in  FIGS. 1 and 2 . A second embodiment of the tube retainer  72  was shown in  FIG. 6 , and a third embodiment of the tube retainer  100  was shown in  FIG. 7 . Any embodiment of the tube retainer may be included in any embodiment of the present invention. 
     A fourth embodiment of the tube retainer is shown in  FIG. 8  attached to the fifth embodiment of the mouth guard  86  of the present invention. The tube retainer  104  includes a flexible clip  106  that extends in front of the mouth guard  86 . Clip  106  has a hollow opening  110 , through which the intubation tube passes, and two prongs  112 ,  114 . The intubation tube is pushed through and past the two prongs  112 ,  114  and is secured in opening  110  through tension applied by the two prongs  112 ,  114 . 
     A fifth embodiment of the tube retainer is shown in  FIGS. 9 and 10  attached to the fourth embodiment of the mouth guard  62  of the present invention. The tube retainer  116  includes two flexible strings  118 ,  120 , shown in  FIG. 9 , that extend from the underside of the superior portion  122  of the mouth guard  62 . Once the intubation tube  126  is inserted in the patient&#39;s throat, strings  118 ,  120  are wrapped around the intubation tube  126  and twisted around each other, shown in  FIG. 10 , securing the intubation tube  126  to the mouth guard  62 . 
     A sixth embodiment of the tube retainer is shown in  FIGS. 11 and 12  attached to the fifth embodiment of the mouth guard  86  of the present invention. The tube retainer  128  includes three semi-circular apertures  130 ,  132 ,  134  that extend forward of the mouth guard  86  at the underside of the superior portion  138  of the mouth guard  86 . The tube retainer  128  is twisted into a serpentine structure, as shown in  FIG. 12 , and the intubation tube is first placed into aperture  134 , woven back through aperture  132 , and passed through aperture  130 . The twisted serpentine structure of tube retainer  128  provides tension among apertures  130 ,  132 ,  134  to secure the intubation tube to mouth guard  86 . 
     The oral airway and intubation assisting device of the present invention may be made of plastic or other sufficiently rigid material, such as silicone, urethane, and the like. Further, the various parts of the oral airway and intubation assisting device may be made from different materials. Further still, the various parts may be made from more than one material. 
     The foregoing description of illustrated embodiments of the invention has been presented for purposes of illustration and description, and is not intended to be exhaustive or to limit the invention to the precise forms disclosed. The description was selected to best explain the principles of the invention and practical application of these principles to enable others skilled in the art to best utilize the invention in various embodiments and various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention not be limited by the specification, but be defined by the claims set forth below.