Abstract:
A two piece endotracheal intubation device is provided having a multidirectional eyepiece, a suction port and a fiber optic assembly that enables a practitioner to apply suction to a patient&#39;s airway while at the same time visualizing the airway from any position relative to the patient for insertion of the endotracheal tube.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention generally relates to an instrument for accessing the laryngeal area of a human body and, more particularly, to an improved laryngoscope for use in intubation.  
         BACKGROUND OF THE INVENTION  
         [0002]    Laryngoscopes are widely known and used in the medical field to facilitate endotracheal intubation of a patient during an emergency situation to provide a positive air passageway for the mechanical ventilation of the lungs of the injured person. Such laryngoscopes are also used during surgical procedures to provide a passageway for the administration of anesthesia. In the human anatomy, the epiglottis normally overlies the glottis opening into the larynx to prevent the passage of food into the trachea during eating. Thus, when undertaking an endotracheal intubation, it is necessary to displace the epiglottis from the glottal opening to permit the air tube to be inserted into the trachea.  
           [0003]    Various laryngoscope constructions are known. The more widely used laryngoscopes consist of an elongate, rigid metal blade which is supportably attached to a handle. These types of laryngoscopes are inserted through the mouth of the patient into the pharyngeal area to displace the tongue and epiglottis and permit direct visualization of the glottis through the mouth opening. Such laryngoscopes are generally provided with a light source which is directed along the blade to illuminate the area beyond the distal end of the blade.  
           [0004]    The standard method for performing intubation of the trachea with conventional laryngoscope blades of the straight or slightly curved type is to place the patient in supine position, tilt the head backwards as far as possible, and distend the lower jaw to widely open the mouth. The blade is then inserted through the mouth into the throat passageway to displace the tongue and epiglottis and expose the glottis of the patient. The larynx is then viewed through the mouth opening from an observation position just above and behind the head of the patient by sighting generally along the axis of the blade. The endotracheal tube is inserted, either orally or transnasally, and passed alongside the blade through the glottis. The foregoing procedure is often made more difficult by the presence of bodily fluids on or in the larynx and trachea which significantly reduce the visibility when using conventional systems.  
           [0005]    The safety and efficacy of procedures for introducing tubular members in the body can be greatly enhanced with the use of remote visualization, where for example, a distal end of an endoscope is introduced in the body to permit visualization of the procedures via an eyepiece of the endoscope optically coupled with an image receiving distal end. Introduction of tubular members with the assistance of remote visualization is highly desirable for various medical procedures; however, even with the assistance of remote visualization, many medical procedures involving introduction of tubular members remain difficult to perform and carry a risk of adverse consequences for the patient. In particular, it is difficult when introducing tubular members into the body to obtain accurate, clear exposure of sites in the body, such as the trachea, through which the tubular members are introduced. Without proper positioning and guidance, the tubular members often cause trauma or injury to anatomical tissue.  
           [0006]    Surgical instruments having means for indirect illumination and visualization of the pharyngeal areas of the body are also known. U.S. Pat. Nos. 3,776,222 and 3,913,568 disclose devices for endotracheal intubation which comprise flexible or articulatable tubular probes having internal fiber optics for lighting and viewing the internal areas of the body. As disclosed in those patents, the probes carry a slidably removable endotracheal tube surrounding their outer surfaces and the probe is directly inserted into the trachea to position the tube. Such devices obviously require the use of relatively large diameter endotracheal tubes in order to be carried on the tubular probe, and their use necessarily is limited to patients with sufficiently large airway passages to accommodate the combined size of the probe and endotracheal tube. Additionally, due to the flexible nature of the probes, it is difficult to manipulate the probe to displace the tongue and epiglottis to permit direct insertion of the tube into the trachea.  
           [0007]    As a consequence, there has been a long felt need for a device which can facilitate intubation so as to easily and quickly accomplish direct laryngoscopic intubation. There is a further need for such a device which is inexpensive enough to be financially accessible for any emergency vehicle. There is further also a need for such a device which enables indirect visualization of a patient&#39;s airway from a 360 degree vantage point.  
         SUMMARY OF THE INVENTION  
         [0008]    The present invention is designed to overcome the aforementioned difficulties during intubation by providing a two piece endotracheal intubation device containing a light source, simultaneous suctioning ability, and a multidirectional eyepiece that enables a practitioner to apply suction to a patient&#39;s airway while at the same time visualizing the airway from any position relative to the patient for insertion of the endotracheal tube.  
           [0009]    In one preferred embodiment, an endotracheal intubation is provided including an optical assembly enclosed by a housing where the optical assembly includes at least one optical fiber having a flexible distal portion and extending outwardly from a first end of the housing. A gooseneck fiber conduit is also provided that extends from a second end of the housing. The gooseneck is flexible along its length so as to be bent into a plurality of angular orientations with respect to the housing. An eyepiece is positioned at an end of the gooseneck having a lens system so that the at least one optical fiber optically communicates with the lens system through the gooseneck. A scabbard is provided for the optical assembly that is sized to receive a portion of the first end of the housing. The scabbard includes at least one optical fiber, and comprises a curved blade having a terminal edge surface and a plurality of spaced conduits longitudinally extending through the scabbard. Advantageously, a first one of the conduits extends longitudinally through the scabbard and opens onto the terminal edge surface of the scabbard. A second one of the conduits extends along an outer surface portion of the scabbard and defines an open channel that is sized to removably receive an endotracheal tube. A third one of the conduits extends longitudinally through the scabbard and comprises two open ends, one of which opens onto the terminal edge surface of the scabbard. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]    These and other features and advantages of the present invention will be more fully disclosed in, or rendered obvious by, the following detailed description of the preferred embodiment of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts and further wherein:  
         [0011]    [0011]FIG. 1 is a perspective view of a two piece endotracheal intubation device having a multi-directional viewing assembly formed in accordance with the present invention;  
         [0012]    [0012]FIG. 2 is a perspective view of the two piece endotracheal intubation device shown FIG. 1, separated so as reveal a fiber optic system;  
         [0013]    [0013]FIG. 3 is a side elevational view of the two piece endotracheal intubation device shown in FIG. 1;  
         [0014]    [0014]FIG. 4 is a top view of the two piece endotracheal intubation device shown in FIG. 3;  
         [0015]    [0015]FIG. 5 is a rear-end view of the two piece endotracheal intubation device shown in FIG. 1;  
         [0016]    [0016]FIG. 6 is an end view of the fiber-scabbard having a endotracheal tube and fiber wand positioned with their respective conduits;  
         [0017]    [0017]FIG. 7 is a perspective view, similar to FIG. 1, showing phantom positions into which the multi-directional viewing assembly of the two piece endotracheal intubation device may be swiveled;  
         [0018]    [0018]FIG. 8 is a perspective view, similar to FIG. 1, showing one embodiment of gooseneck tube; and  
         [0019]    [0019]FIG. 9 is a perspective view, similar to FIG. 1, showing another embodiment of gooseneck tube. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0020]    This description of preferred embodiments is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description of this invention. The drawing figures are not necessarily to scale and certain features of the invention may be shown exaggerated in scale or in somewhat schematic form in the interest of clarity and conciseness. In the description, relative terms such as “horizontal,” “vertical,” “up,” “down,” “top” and “bottom” as well as derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing figure under discussion. These relative terms are for convenience of description and normally are not intended to require a particular orientation. Terms including “inwardly” versus “outwardly,” “longitudinal” versus “lateral” and the like are to be interpreted relative to one another or relative to an axis of elongation, or an axis or center of rotation, as appropriate. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. The term “operatively connected” is such an attachment, coupling or connection that allows the pertinent structures to operate as intended by virtue of that relationship. In the claims, means-plus-function clauses are intended to cover the structures described, suggested, or rendered obvious by the written description or drawings for performing the recited function, including not only structural equivalents but also equivalent structures.  
         [0021]    The present invention provides a two piece endotracheal intubation device or intubator  5  that includes a multi-directional viewing assembly  8  which enables indirect visualization of a patient&#39;s airway from positions ranging 360 degrees around the patient. Two piece intubator  5  includes a fiber-scabbard  10  and an optical assembly  13 . Fiber-scabbard  10  is formed from a hard polymer material formed so as to generally comprise the curved shape of a conventional intubation blade, e.g., a Macintosh or Miller blade. Fiber-scabbard  10  includes a proximal end  12  and a curved distal end  14 . Proximal end  12  defines an open ended shroud  17  that is sized and shaped to accept a distal portion of optical assembly  13 . An optical passageway  20  extends throughout the length of fiber-scabbard  10 , and opens at the terminal face  21  of curved distal end  14 . A proximal open end of an optical passageway  20  is located on the interior of shroud  17 . A second passageway  27  also extends throughout the length of fiber-scabbard  10  in substantially parallel relation to optical passageway  20 , and also opens at terminal face  21  of curved distal end  14 . A port  24  is arranged below shroud  17 , in fluid flow communication with second passageway  27 . Direct suction may be applied to port  24  so that foreign material and secretions from the throat may be transferred through second passageway  27  thereby eliminating the need for suction catheters or the like. A channel formed on the outer curved surface of distal end  14  of fiber-scabbard  10  provides an endotracheal tube receptacle  30 . Tube receptacle  30  is sized so as to snugly, but releasably accommodate an endotracheal tube  31  of the type well known in the art. Such a tube  31  may be prepositioned within tube receptacle  30  for direct intubation. A top opening  34  is partially obstructed by a plurality of spaced-apart, interdigitated fingers  36 , which aid in snugly but releasably maintaining tube  31  within tube receptacle  30  during insertion of fiber-scabbard  10  into a patient&#39;s mouth and throat.  
         [0022]    Optical assembly  13  includes a body housing  40 , a fiber probe  43 , and an adjustable eyepiece  47  (FIG. 2). Body housing  40  is sized and shaped to be releasably received within shroud  17  of fiber-scabbard  10 . Body housing  40  encloses a conventional light source and associated battery power supply (not shown) with an on/off button  48  arranged so as to be easily accessible to an operator. Fiber probe  43  comprises an elongate, flexible probe that includes at least two optical fibers  50   a  and  50   b , e.g., elongate, flexible strands of optical quality glass or a relatively rigid, light-conductive polymeric material, such as, methyl methacrylate. Optical fiber  50   a  is interconnected at one end to the light source within body housing  40 , while the other end is open at the distal end of fiber probe  43 . A lens  44  or similar light conditioning or focusing device may be sealingly disposed over the open end of optical passageway  20  at terminal face  21  of curved distal end  14  of fiber-scabbard  10 , or over the free end of optical fiber  50   a . This arrangement has the added benefit of preventing bodily fluids and the like from entering optical passageway  20  and contaminating fiber probe  43 . Optical fiber  50   b  extends from the distal end of fiber probe  43 , through body housing  40 , and is optically interconnected with adjustable eyepiece  47 . Adjustable eyepiece  47  comprises an ocular housing  53  disposed at one end of a “gooseneck” tube  58 , and provides for ease of visualization of the larynx and trachea.  
         [0023]    Ocular housing  53  supports a conventional lens system  59  and is sized and shaped to allow a person to place their eye in close, focusing proximity to a conventional lens system  59  operatively mounted within ocular housing  53 . Optical fiber  50   b  extends from body housing  40  to ocular housing  53  through gooseneck tube  58 , and optically communicates with lens system  59 . Gooseneck tube  58  may be formed of a coiled, interlocking metal strip  60  in a conventional manner, the interlocking being produced with a sufficiently frictional fit for supporting and maintaining ocular housing  53  in a desired position and orientation (FIGS. 7 and 8). For example, gooseneck  58  may be curved in a single plane or in orthogonal planes so as to allow for indirect visualization of a patient&#39;s airway from positions ranging 360 degrees around the patient&#39;s head. Alternatively, a bendable wire  64  may be placed within a flexible, resilient tube  67  so as to form gooseneck tube  58  (FIG. 9). In this alternative, bendable wire  64  extends the full length of gooseneck tube  58  or at least a substantial portion of its length. Bendable wire  64  is formed of a bendable or ductile metal so that it may take a set at a desired curvature and will tend to hold eyepiece  47  at that curvature in the absence of externally-applied re-forming forces.  
         [0024]    Optical assembly  13  is positioned within fiber-scabbard  10  by inserting fiber probe  43  into the open proximal end of optical passageway  20 . Once in this position, optical assembly  13  is moved toward the interior of shroud  17  until it enters fiber-scabbard  10  as shown in FIG. 1. In this position, the distal end of fiber probe  43  is positioned at terminal face  21  of curved distal end  14  of fiber-scabbard  10 .  
         [0025]    A tube  30  is then positioned within tube receptacle  30  of fiber-scabbard  10  by press-fitting it through the interdigitated fingers  36  so that it is held releasably in place within the outer portion of fiber-scabbard  10 . Once this assembly is completed, an intubation procedure may be begun.  
         [0026]    More particularly, and unlike conventional intubation devices, the patient&#39;s head need not be tilted backwards at all. Only the lower jaw needs to be somewhat distended, and the mouth open sufficiently to introduce two piece endotracheal intubation device  5 . Curved distal end  14  of fiber-scabbard  10  is then inserted through the mouth into the throat passageway, so as to displace the tongue and epiglottis, and expose the glottis of the patient. Once in this position, suction may be applied to port  24 , so as to draw bodily secretions and fluids away from the glottis and larynx through second passageway  27 . Advantageously, this procedure may be visualized via viewing assembly  8  by swiveling or bending gooseneck tube  58 , so as to position ocular housing  53  at a place convenient for the person performing the intubator to place their eye in close, focusing proximity to conventional lens system  59 . It will be understood that viewing assembly  8  may be bent or maneuvered into a plurality of curved shapes, as needed, to provide for the comfort and access by the person forming the intubation and to allow for controlled viewing of the intubation process.  
         [0027]    With the patient&#39;s larynx in view through eyepiece  47 , tube  30  is maneuvered through the larynx and into the trachea of the patient, all the while being observed by the person performing the intubation. Once tube  30  has been properly positioned within the trachea, optical assembly  13  is first removed from fiber-scabbard  10  by simply pulling housing  40  out from within shroud  17 , and moving optical assembly  13  away from proximal end  12  of fiber-scabbard  10  until fiber probe  43  has been removed from optical passage  20  and exited the open end of shroud  17 . Once this procedure is completed, while holding tube  30 , fiber-scabbard  10  is then slid along tube  30  until it exits the patient&#39;s mouth and can be removed from tube receptacle.  
       ADVANTAGES OF THE INVENTION  
       [0028]    Numerous advantages are obtained by employing the present invention.  
         [0029]    More specifically, an endotracheal intubation device is provided which avoids many of the aforementioned problems associated with prior art devices.  
         [0030]    In addition, an endotracheal intubation device is provided which allows the operator to stand not only at the top of the patient&#39;s head while performing an intubation, (which is the only preferred) but also permits endotracheal tube placement under direct visualization of the target area, the larynx.  
         [0031]    Furthermore, an endotracheal intubation device is provided in which an emergency care provider no longer needs to reposition or hyperextend the neck to facilitate visualization of the vocal cords, such as in the case of an automobile accident when the person in need of respiratory assistance and there is a potential threat of neck or cervical spine injuries, which can lead to further neck, spine, and spinal cord damage, and even paralysis.  
         [0032]    Also, an endotracheal intubation device is provided which does not require the hyperextension of the neck to visualize the vocal cords and other anatomy, thus alleviating previous intubation problems, such as broken or chipped teeth.  
         [0033]    In addition, an endotracheal intubation device is provided, including an eyepiece that may be oriented 360° about the patient&#39;s mouth and head, so as to allow the operator to intubate through a car window or in tight or closed spaces, something that a conventional emergency care-giver has not been able to do. This is extremely helpful when a victim is trapped inside of a car where they would normally not be able to be intubated.  
         [0034]    Furthermore, an endotracheal intubation device is provided having a multi-directional viewing assembly that permits intubation from the side of a bed in a medical care facility. Previously, such intubation had to be performed from only the head of the bed, necessitating removal of the headboard of the bed to create a space between the bed and the wall, and the person maneuvering him/herself through the numerous intravenous lines and monitor equipment to be able to stand between the wall and the head of the bed, in order to place the endotracheal tube within the patient&#39;s trachea.  
         [0035]    Also, an endotracheal intubation device is provided having the flexibility of a gooseneck assembly, so that the viewer is allowed to move an image in the eyepiece, clockwise or counterclockwise, nearly a full  3600  about the patient&#39;s head, thereby allowing for a plurality of positions.  
         [0036]    Also, an endotracheal intubation device is provided having front to back flexion of the viewing assembly in relationship to the body of the device allowing for near full flexion to allow the operator to be located anywhere, e.g., at the head of the victim, on the side of the victim, or along the body of the victim, etc., for better positioning during endotracheal intubation, with direct visualization of the vocal cords.  
         [0037]    In addition, an endotracheal intubation device is provided, having the capability to be used to intubate from the side of a patient, thereby decreasing the spread of infectious diseases and other bacterial matter to the operator by not having to hyperextend the neck to see the vocal cords, and thereby decreasing the risk of coughing up into the operator&#39;s eyes and face, secretions laden with infectious diseases, such as HIV, hepatitis, multi-drug resistant TB, etc.  
         [0038]    In addition, an endotracheal intubation device is provided, having a rotational eyepiece that permits intubation through a car window, or when an accident victim is trapped inside an automobile.  
         [0039]    It is to be understood that the present invention is by no means limited only to the particular constructions herein disclosed and shown in the drawings, but also comprises any modifications or equivalents within the scope of the claims.