Abstract:
An intubation instrument for intubating a patient&#39;s trachea including an imager module having a base unit with a finger loop and a longitudinal member attached to the distal end of the base unit, as well as a blade having a handle that is hollow and mates with the outer surface of the longitudinal member forming a male-female connection, the distal end of the blade projecting laterally therefrom, the distal end of the blade being insertable into a human during intubation.

Description:
FIELD OF THE INVENTION 
     This invention is directed to an intubation system and tools for intubation. The invention is particularly useful in various procedures for intubating a patient&#39;s trachea. 
     BACKGROUND OF THE INVENTION 
     Intubation instruments such as video laryngoscopes are known in the art. Known laryngoscope systems include U.S. Pat. No. 5,827,178 to Berall; U.S. Pat. No. 6,665,377 to Pacey; U.S. Pat. No. 6,543,447 to Pacey; U.S. Pat. No. 5,287,488 Cubb et al.; Japanese Patent No. JPH05-292504; U.S. Pat. No. 5,645,519 to Lee; U.S. Pat. No. 5,800,344 to Wood; U.S. Pat. No. 5,363,838 to George; U.S. Pat. No. 5,381,787 to Bullard; Crosby, Techniques using the Bullard Laryngoscope, Anesthesia and Analgesia 81: 1314-1315 (1995); WO 97/15144 to Shapiro; and U.S. Pat. No. 4,592,343 to Upsher. 
     Known commercial laryngoscope systems include the Pentax AIRWAY SCOPE and the Verathon GLIDESCOPE RANGER. However, these laryngoscope systems suffer from various deficiencies. 
     One problem known to laryngoscopes is that the imager shaft may become twisted when being inserted into a blade element. If the imager shaft is not inserted correctly into the blade element, then the imager shaft may become stuck and the image produced by the camera does not appear upright or appears off-center in a display. 
     Other problems known in the prior art involve the cable becoming damaged when the imager shaft is pulled out of the single-use blade after use. Another known problem in the prior art involves difficulties in disinfecting the imagers in known laryngoscope systems. 
     Thus, it is desirable to provide a video laryngoscope system that overcome and solve these above mentioned problems. 
     SUMMARY OF THE INVENTION 
     Accordingly, it is an object of the invention to provide a laryngoscope system that overcomes and solves the above mentioned problems in the prior art. It is an object of the invention to provide a video laryngoscope with disposable blade, such that the blade is a single-use blade. 
     It is another object of the invention to provide a video laryngoscope where the imager shaft does not become stuck when the imager shaft is inserted into the blade. 
     These objects of the invention are achieved by providing an intubation instrument comprising: an imager module, the imager module including a base unit having a proximal end and a distal end, the proximal end of the base unit having a finger loop, and a longitudinal member, the longitudinal member attached to the distal end of the base unit and projecting longitudinally away from the distal end of the base unit; and a blade, the blade having a proximal end and a distal end, the proximal end forming a handle that is hollow and that mates with the outer surface of the longitudinal member forming a male-female connection, and the distal end of the blade projecting laterally therefrom, the distal end of the blade being insertable into a human during intubation. 
     In certain embodiments, the base unit includes a flange at the distal end of the base unit, the flange on the base unit abutting against a flange in the proximal end of the blade. This flange to flange abutment is beneficial as it prevents moisture or fluids from entering into the hollow portion of the handle, thus, insulating the imager module from moisture and/or fluids. 
     In certain embodiments, the longitudinal member includes a ball plunger on the outside surface of the longitudinal member. The ball plunger may be flexible and may have a spring between it and the outer surface of the longitudinal shaft, such that when force is exerted on the ball plunger, it retracts into the longitudinal member, however, it is forced outward by the spring, when no external force is provided on the ball plunger. 
     In certain embodiments, the blade includes a ball detent on the inside surface of the handle of the blade, the ball detent adapted to interact with the ball plunger of the longitudinal member so that the longitudinal member and blade are connected with each other during use of the intubation instrument. 
     In certain embodiments, when in use, the ball plunger of the longitudinal member locks into the ball detent on the inside surface of the handle of the blade to lock the blade to the longitudinal member. 
     In certain embodiments, the intubation instrument further comprises electronic wiring, the electronic wiring containing a camera at its distal end. 
     In certain embodiments, the imager module and the blade are adapted to receive the electronic wiring, the electronic wiring passing through the imager module and the blade. 
     In certain embodiments, the blade includes a guide located within the handle of the blade, the guide including a channel. 
     In certain embodiments, the channel is adapted to receive electronic wiring, the electronic wiring containing a camera at its distal end. 
     In certain embodiments, the electronic wiring is connected to a display for displaying images received by the camera. 
     In certain embodiments, the electronic wiring is partially contained in the distal end of the blade. 
     In certain embodiments, the longitudinal member includes electronics to control the imager module. The electronics may include electronics for the camera located at the distal end of the cable. 
     In certain embodiments, the base unit includes a hollow portion having a loop, the hollow portion adapted to receive electronic wiring. 
     In certain embodiments, the blade is disposable. In certain embodiments, the blade is made of plastic or a hard polymer material. 
     In certain embodiments, the intubation instrument is a video laryngoscope. 
     In certain embodiments, the imager module is separable from the blade, wherein the imager module is disinfected after being used and the blade is disposed of after use. 
     In certain embodiments, the electronic wiring is flexible. In certain embodiments, the electronic wiring does not kink. 
     In certain embodiments, the blade includes a lens at its distal end. In certain embodiments, the lens has a rectangular shape. In certain embodiments, the lens is a single, a doublet or may include more than one lens. 
     In certain embodiments, the electronic wiring passes through a loop portion in the base unit. 
     In certain embodiments, the channel in the blade is sandblasted for easier insertion and removal of the electronic wiring. 
     In certain embodiments, the imager module is disinfected after use and then is used again, while the blade is disposed of and is a single-use blade. In certain embodiments, the handle is part of the single-use blade. 
     Other objects of the invention are achieved by providing an intubation instrument comprising: an imager module, the imager module including a base unit having a proximal end and a distal end, the proximal end of the base unit having a finger loop, and a longitudinal member, the longitudinal member attached to the distal end of the base unit and projecting longitudinally away from the distal end of the base unit, the longitudinal member having a ball plunger on the outside surface of the longitudinal member; and a blade, the blade having a proximal end and a distal end, the proximal end forming a handle that is hollow and that mates with the outer surface of the longitudinal member forming a male-female connection, and the distal end of the blade projecting laterally therefrom, the distal end of the blade being insertable into a human during intubation, the blade including a ball detent on the inside surface of the handle of the blade, the ball detent adapted to interact with the ball plunger of the longitudinal member so that the longitudinal member and blade are connected with each other during use of the intubation instrument, wherein when in use, the ball plunger of the longitudinal member locks into the ball detent on the inside surface of the handle of the blade to lock the handle to the longitudinal member and handle. 
     In certain embodiments, the blade is disposable blade. In certain embodiments, the intubation instrument is a laryngoscope. 
     In certain embodiments, the intubation instrument further comprises electronic wiring. In certain embodiments, the electronic wiring is located within the proximal end of the imager module. In certain embodiments the shape of the proximal end of the imager module matches the opening in the single-use blade so that incorrect insertion of the imager module into the blade is prevented. 
     In certain embodiments, the intubation instrument further comprises a guide inside the handle of the blade. In certain embodiments, the guide includes a channel. In certain embodiments, the channel is adapted to receive electronic wiring containing a camera at its distal end. In certain embodiments, the guide interacts with ball plunger on imager module, so imager module is inserted properly into the blade. 
     In certain embodiments, the channel in the blade is sandblasted for easier insertion/removal of the imager module, as less friction in the inside of the handle is created. In certain embodiments, the handle is sandblasted on the outside for a better grip. 
     In certain embodiments, the finger loop portion makes it easy for a user to manipulate the imager module. The finger loop makes it easier to remove the longitudinal member and prevents kinking of the cable during use. Moreover, the finger loop helps lead the cable away from the instrument and from the patient so it is not in the way during intubation. 
     This finger loop is advantageous as it solves kink problems of the cable and assists in removal of the blade from the imager module, which is advantageous as prior art systems become stuck together after use as moisture can cause these elements to become stuck to one another. The present invention includes the finger loop design, whereby easy separation of the blade and imager module is possible. 
     Other objects of the invention and its particular features and advantages will become more apparent from consideration of the following drawings and accompanying detailed description. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of the video laryngoscope used in a patient; 
         FIG. 2  is a perspective view of the imager module of  FIG. 1 ; 
         FIG. 3  is a side view of the imager module of  FIG. 1 ; 
         FIG. 4  is a top view of the imager module of  FIG. 1 ; 
         FIG. 5  is a front view of the imager module of  FIG. 1 ; 
         FIG. 6  is a top view of the blade of  FIG. 1 ; 
         FIG. 7  is a cross section view of the blade of  FIG. 6 ; 
         FIG. 8  is an exploded detail view along axis  8  of  FIG. 7 ; 
         FIG. 9  is an exploded detail view along axis  9  of  FIG. 7 ; 
         FIG. 10  is an exploded view of the imager module and blade of  FIG. 1 ; and 
         FIG. 11  is a cross section view of the imager module and blade of  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The following detailed description illustrates the invention by way of example, not by way of limitation of the principles of the invention. This description will enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention. 
     Referring to  FIG. 1  a perspective view of intubation instrument  1000  is shown being used in a patient  1300 . The intubation instrument  1000  is shown entering the patient  1300  through the patient&#39;s mouth. The intubation instrument  1000  extends just outside a patient&#39;s trachea, thus, providing views of a patient&#39;s trachea. 
     The intubation instrument includes blade  600  attached to imager module  200 . The imager module  200  has a cable or electronic wiring that is connected to display  100 . The display  100  may be a video monitor, computer, or other screen where an image produced from the imager module  200  may be displayed, so that a doctor or nurse may view into the patient. In certain embodiments, the display can be directly attached to the handle of the laryngoscope or to the imager module  200 . 
       FIG. 2  shows a perspective view of the imager module  200  of  FIG. 1 . Imager module  200  includes a base unit  230  and a longitudinal member  210  (also considered to be a longitudinal shaft). 
     The base unit as shown includes finger loop  240 , flange  220 , and cable  250 . The cable  250  may also be referred to as electronic or electrical wiring. The finger loop may allow a surgeon or doctor to manipulate the imager module  200 . 
     The longitudinal member  210  is shown having a ball plunger  205  on the outside surface of the longitudinal member  210 . The longitudinal member  210  also has a front surface  215 . The front surface  215  is fitted to abut an inner surface of the handle  610  (shown in  FIG. 11 ). 
     Cable or electrical wiring  250  is shown passing through the imager module  200  including the base unit  230  and longitudinal member  210 . The cable  250  passes by the finger loop  240  and through the longitudinal member  210 . The cable  250  is flexible and has an imaging unit  260  at its distal tip. The imaging unit includes a light source  270  (such as an LED) and a camera unit  265  that is able to take an image during use. The camera unit  265  can be a CMOS sensor or any other solid-state image sensor. In certain embodiments, the distal part of imaging unit  260  can be a black plastic part that reduces reflections and scattered light from an LED. This solves a problem because the LED is inside the blade and light can be scattered by the inside walls of the blade or the distal window or lens. In certain embodiments, the black plastic part may be made of PEEK. 
       FIGS. 3-5  show various views of imager module  200 . These figures show a side, top, and front view of the imager module  200 . It is shown in  FIG. 3  that the flange  220  is perpendicular to the longitudinal member  210 . 
     It is also shown in  FIG. 3  that the cable  250  is flexible as it is able to be rotated 90 degrees through the base unit  230  and into the longitudinal member  210 . 
       FIG. 6  is a top view of the blade  600  shown in  FIG. 1 . Blade  600  includes a guide  625  on the inside surface of the handle  610  of the blade  600 . The blade  600  is also shown having a handle  610  having a channel  630  for reception of the longitudinal member  210 . In broken lines, the distal part  650  of the blade is shown. It is this distal part  650  of the blade that extends just outside a patient&#39;s trachea. 
     In  FIG. 7 , a cross section view of the blade of  FIG. 6  is shown along axis  7 - 7 . Here, the blade  600  is shown having a handle section  620  at the proximal end of the blade  600  with distal part  650  extending substantially perpendicular to the handle  610 . 
     The handle  610  is shown having a hollow middle portion  630 , the hollow portion  630  adapted to receive the imager module  210 . The handle  610  includes a guide portion  625 , the guide portion  625  used for guiding the imager module  210 , so that it is placed into the proper position so ball plunger  205  is aligned with the ball detent. The handle  610  has section  800 , shown in more detail in  FIG. 8 . 
     The distal part  650  of blade  600  has a channel  640 . The distal part  650  is curved for easy access into the throat of a patient and just outside a patient&#39;s trachea. Furthermore, distal part  650  is shown having section  900 , shown in more detail in  FIG. 9 . 
       FIG. 8  is an exploded detail view of section  800  of  FIG. 7 . This is also shown along axis  8  in  FIG. 7 .  FIG. 8  shows guide  625  for guiding the imager module into the hollow part  630  of the handle  610 . Here, ball detent  830  is shown adapted to interact with the ball plunger  205  of the longitudinal member  210  so that the longitudinal member  210  and blade  600  are connected with each other during use of the intubation instrument  1000 . 
       FIG. 8  also shows ridge  820 , where the ball plunger  205  passes over the ridge and settles into ball detent  830 . Furthermore, tapered surface  810  is also shown whereby upon applying pressure downwards, the ball plunger  205  is able to slide down the tapered surface  810 , and is able to be released from the ball detent  830 , leading to separation of the blade  600  and imager module  200 .  FIG. 8  also shows the handle  610  being connected to distal part  650  of the blade  600 . 
     In certain embodiments, when in use, the ball plunger  205  of the longitudinal member  210  locks into the ball detent  830  on the inside surface of the handle  610  of the blade  600  to lock the blade  600  to the longitudinal member  210 . 
     In certain embodiments, the ball plunger  205  may be flexible and may have a spring (not shown) between it and the outer surface of the longitudinal shaft  210 , such that when force is exerted on the ball plunger  205  by the inner surface of the handle  610 , it retracts into the longitudinal member  210 . However, when the ball plunger  205  is aligned with the ball detent  830 , no force is provided on the ball plunger  205  and it is forced outward by the spring. The ball plunger  205  and ball detent  830  are then locked in place and the imager module  200  is secured to the blade  600 . 
     To release the imager module  200  from the blade  600 , a user may exert pressure downwards so that the ball plunger  205  is released from the ball detent  830 , thus releasing the securing mechanism between these two elements. A user may also rotate the imager module  200  within the blade  600 , thus, providing a releasing mechanism between these two elements. In certain embodiments, the shape of the imager module actually prevents rotation, as it is form-fit with the blade. Thus, incorrect insertion of the imager module into the blade is prevented 
       FIG. 9  is an exploded detail view of section  8  of  FIG. 7 .  FIG. 9  shows channel  640  formed in the distal part  650  of the blade  600 . In this section lens  910  is shown as well as lens cover  920 . A lens may be provided over the end of the camera of the cable  250  in certain embodiments of the invention. The lens  910  may be a single lens, doublet lens, fish eye lens, or other known lens used for intubation systems known in the art. 
       FIG. 10  is an exploded view of the imager module and blade of  FIG. 1 . Here the imager module  210  is shown being able to be inserted into the blade  600 , specifically handle  610 . Furthermore, ridges  1010 ,  1020  and  1030  are shown on the handle  610 , the ridges allowing a user to easily grip the handle  610 . 
       FIG. 11  is a cross section view of the imager module  200  inserted into the blade  600 . The flange  220  of the base unit  230  is shown abutting against the proximal end  620  of the handle  610 . Furthermore, the cable  250  is shown within channel  640 . The cable  250  is shown as being flexible and not filing the entire channel  640 . 
     Furthermore,  FIG. 11  shows various elements of base unit  230 , including loop  235 , which encloses cable  250 , as well as finger loop  240 . The loop  235  in base unit  230  makes it difficult for the cable to be removed from the imager module, so that a user does not just pull the cable causing possible damage to the cable connection. 
     Furthermore, the finger loop  240  makes it easier to remove the longitudinal member  210  and prevents kinking of the cable during use. Moreover, the finger loop  240  helps lead the cable away from the instrument and from the patient so it is not in the way during intubation. This is because the cable  250  is parallel to the distal part  650  of the blade and is not in the way when a patient is being intubated. 
     The laryngoscopes of the invention come in different blade sizes and shapes for different patients and intubation situations. Such intubation situations include intubating children or adults, obese patients, and patients whose neck may not be moved or who are bleeding in the throat. 
     In certain embodiments, the blade  600  may have different shapes that are commonly used in laryngoscopes. In certain embodiments, the blade may be a Macintosh blade or a Miller blade. In certain embodiments, the blade may be a Dörges blade (D-blade). In certain embodiments, one imager module may be used with different disposable blades and may be form-fit to different disposable blades. 
     While the invention has been specifically described in connection with certain specific embodiments thereof, it is to be understood that this is by way of illustration and not of limitation, and that various changes and modifications in form and details may be made thereto, and the scope of the appended claims should be construed as broadly as the prior art will permit. 
     The description of the invention is merely exemplary in nature, and, thus, variations that do not depart from the gist of the invention are intended to be within the scope of the invention. Such variations are not to be regarded as a departure from the spirit and scope of the invention.