Patent Publication Number: US-2022218929-A1

Title: Tube introducer intubation device

Description:
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 62/856,103, filed Jun. 2, 2019. 
    
    
     FIELD OF THE INVENTION 
     The present invention is directed to methods and apparatus for performing oral intubation. 
     BACKGROUND 
     Various medical treatments require assisted respiration, for example, from a ventilator. By way of non-limiting surgical anesthesia, illness affecting respiratory function, and trauma can all require assisted respiration. Assisted respiration is carried out through a tube inserted through the mouth of the patient and directed to the larynx. The process of inserting the tube into position for respiration is known as oral intubation. 
     In some patients, the process of intubation is complicated by anatomical conditions, known in the art as difficult airways. To intubate a patient with a difficult airway, it is necessary for the medical professional to be able to navigate through any obstructions in the mouth and at the rear of the throat to successfully place a tube to establish an airway. 
     A difficult airway can present risk of intubation failure, which can be life threatening, or can result in injury due to the urgency to complete the intubation. Many intubations involve the use of video laryngoscopy, which involves a specialized imaging device designed to provide video images of the patient&#39;s airway to assist the physician in the intubation procedure. Other methods and devices have been used in conjunction with the video laryngoscope, and some that use other imaging and guiding techniques, to improve the intubation procedure. 
     In many prior art devices, the airway tube is guided into the airway using an introducer or stylet. In one prior art device, an introducer mechanism has an actuating tip. This device, a version of which is shown in U.S Patent Publication no. 2017/0203075, bends in a single direction, providing one degree of freedom movement of the actuating tip of the introducer. 
     An alternative to the inexpensive, disposable options is using a bronchoscope to hold and transport the tracheal tube and a video scope to view the tissue on the way through the patient&#39;s throat. Unfortunately, cleaning the bronchoscope after each use or replacing a broken device is prohibitively expensive. 
     SUMMARY 
     At least one embodiment described herein resolve the issues of prior art solutions to intubating difficult airways using a multi-dimensionally articulable introducer. The introducer eases placement of the tracheal tube when performing oral intubation in difficult airways. 
     A first embodiment is an endotracheal tube introducer that includes a controller, a flexible tip, and a tube guide. The controller has an actuator and a rotatable bearing. The actuator is operably coupled to move the rotatable bearing. The tube guide is operably coupled between the controller and the flexible tip. The flexible tip is operably coupled to the rotatable bearing to move in at least two degrees of freedom responsive to movement of the actuator. 
     Another aspect of the invention is a novel intubation method using the multi-dimensional articulable introducer or stylet. Once the introducer unit has been steered into place beyond the vocal cords with the assistance of the actuator and flexible tip, the tracheal tube can be slid off of the guide tube and into place in the airway. The device simplifies locating the tube with enhanced range of motion maneuverability through the airway. The steering intubation device decreases the likelihood of injuries and mortalities associated with intubation of difficult airways. 
     The above-described features and advantages, as well as others, will become more readily apparent to those of ordinary skill in the art by reference to the following detailed description and accompanying drawings 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a perspective view of a first embodiment of an articulable stylet or introducer; 
         FIG. 2  shows a side plan view of the introducer of  FIG. 1 ; 
         FIG. 3  shows a fragmentary perspective view of the tube guide and flexible tip of the introducer of  FIG. 1  illustrating one aspect of the movement of the flexible tip; 
         FIG. 4  shows a side plan view of the controller of the introducer of  FIG. 1 ; 
         FIG. 5  shows a perspective view of the controller of  FIG. 4  with one of the side covers removed; 
         FIG. 6  shows an exploded perspective view of the controller of  FIG. 4 ; 
         FIG. 7  shows an exploded perspective view the flexible tip of the introducer of  FIG. 1 ; 
         FIG. 7A  shows a fragmentary perspective view of the nub of the flexible tip with wire segments assembled thereon; 
         FIG. 8  shows a perspective view of the introducer with an endotracheal tube disposed thereon; 
         FIG. 9  shows a flow diagram of an exemplary method of using the introducer of  FIG. 1 ; 
         FIG. 10  shows a fragmentary plan view of the introducer with an endotracheal tube affixed thereto; 
         FIG. 11  shows a fragmentary plan view of the introducer with the endotracheal tube partially removed; and 
         FIG. 12  shows a plan view of an alternative embodiment of a controller that may be used in the introducer of  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 1  shows a perspective view of a first embodiment of an articulable stylet or introducer  10 .  FIG. 2  shows a side plan view of the introducer  10 . As will be discussed further below, the introducer  10  is used in an intubation procedure to place an endotracheal tube through the mouth and into the glottic opening of a patient. By way of example,  FIG. 8  shows an endotracheal tube  200  disposed over the introducer  10 , ready for oral insertion into the patient. In general, the introducer  10  and tube  200  are advanced through the mouth into the glottic opening, and then the introducer  10  is pulled out, leaving the endotracheal tube  200  in place. Ventilation equipment, not shown, can then be attached to the endotracheal tube  200  to assist the patient in ventilation. 
     With reference to  FIGS. 1 and 2 , a first embodiment is an articulable introducer  10  that includes a controller  12 , a tube guide  14  and a flexible tip  16 . In general, the controller  12  includes, a digitally manipulatable actuator  18 , a rotatable bearing  20  and a handle  38 . The actuator  18  is fixedly coupled to move the rotatable bearing  20 . As will be discussed in further detail below, the handle  38  supports the bearing  20  such that the bearing can move in at least two degrees of freedom or at least two dimensions with respect to the handle  38  responsive to corresponding movement of the actuator  18 . 
     The bearing  20  is operably coupled to the flexible tip  16  such that the flexible tip  16  moves in a way that corresponds to the rotatable movement of the bearing  20 . Because the actuator  18  is fixedly coupled to the bearing  20 , a user may manipulate the position of the flexible tip via movement of the actuator  18 . In this manner, the actuator acts like a joystick. The unactuated position of the flexible tip  16  is in the axially outward direction from the end of the tube  14 . This position is referred to as the rest position or center position  30 . 
     In this embodiment, the relative movement of the flexible tip  16  with respect to the tube guide  14  (or the center/rest position  30 ) is substantially spherical in nature. In a spherical coordinate system (r, θ, φ), flexible tip  16  is movable in the θ (longitude) dimension and in the φ (latitude) dimension. With reference to  FIG. 1 , the flexible tip  16  is controllably movable or articulable (relative to the tube guide  14  or center/rest position  30 ) in a 360 degree range in the φ dimension, thus allowing the user to move the tip  16  in the forward direction  22 , the backward direction  24 , the right direction  26  and the left direction  28 , as well as all angular directions in between. 
       FIG. 3  shows the movement of the flexible tip  16  in the θ dimension, which has a range  32  of approximately 90 degrees. In particular,  FIG. 3  shows a fragmentary perspective view of the tube guide  14  and flexible tip  16  illustrating the movement in the θ dimension of the flexible tip  16  from center position  30 . In particular,  FIG. 3  shows four exemplary positions  30 ,  34   a ,  34   b ,  34   c  of the flexible tip  16 , including the center position  30 , and three positions  34   a ,  34   b ,  34   c  having different non-zero angled in the θ direction. 
     As a consequence, the user may use the actuator  18  to bend (movement in the θ direction) in the forward direction  22 , the backward direction  24 , the right direction  26  and the left direction  28 , as well as angular directions therebetween (φ angle). 
     It will be appreciated that the at least some advantages described herein can be achieved if the range of latitudinal position is less than 360 degrees, and/or of the range of longitudinal movement is less than 90 degrees. Indeed, at least some embodiments will have a range of longitudinal movement (i.e. bend angle) closer to 45 degrees. Having the ability to manipulate the tip to any set of multiple latitudinal (i.e. φ) positions and longitudinal positions (i.e. θ) provides at least some of the advantages discussed below. Again, from the user&#39;s perspective, this allows the tip  16  to bend (θ movement) in more than one left-right-forward-back (φ) direction. It will further be appreciated that the bending motion need not be spherical, but may take other shapes. As long as the tip  16  articulates in multiple left-right-forward-back (φ) directions, the user gains advantages. 
     Referring again to the general structure of the introducer  10 ,  FIGS. 4, 5 and 6  shows the controller  12  in further detail, with a fragmentary portion of the tube guide  14 .  FIG. 4  shows a side plan view of the controller  12  with one of the covers removed,  FIG. 5  shows a perspective view of the controller  12  with one of the side covers removed, and  FIG. 6  shows an exploded perspective view of the controller  12 . 
     Referring to  FIGS. 1, 4, 5 and 6 , the handle  38  includes a first cover  38   a  and a second cover  38   b  joined a peripheral central seam  38   c . The first cover  38   a  and second cover  38   b  have designs that a largely symmetrical to each other along the same  38   c . The handle  38  has a back side  40 , a left side  41 , a front side  42 , a right side  43 , a top side  44  and a bottom  46 . Each of the first cover  38   a  and the second cover  38   b  forms about half of each of the sides  40 ,  42 ,  44  and the bottom  44 . The first cover  38   a  includes the left side  41  and the second cover  38   b  includes the right side  43 . 
     The back side  40 , the left side  41 , the front side  42 , and the right side  43  form a handle structure that extends from the top side  44  to the bottom  46 , and which is configured to receive an adult human grip. The front side  42  preferably has finger grooves  48  formed therein, to facilitate a stable grip with a free thumb for manipulating the actuator  18 , which extends from the top side  44 . In this embodiment, the back side  40 , the front side  42 , the top side  44  and the bottom  46  are largely symmetrical about the intersection seam  38   c  of the two covers  38   a ,  38   b , which allows for use by in either the right hand or the left hand. The handle  38  defines a vertical axis α that is intermediate back side  40 , the left side  41 , the front side  42 , and the right side  43 . 
     As shown in  FIG. 6 , the cover  38   a  and cover  38   b  are coupled by a plurality of fasteners  38   d . In  FIGS. 4 and 5 , the cover  38   a  has been removed to reveal the interior structure of the cover  38   b . It will be appreciated that the cover  38   a  has a mirror image of the interior structure of the cover  38   b . With reference to  FIGS. 5, 6 and 7 , the cover  38  includes a bearing seat  50 , a funnel section  56 , and a tube seat  60 . 
     The bearing seat  50  is configured to receive and retain the bearing  20  such that the bearing  20  may rotatable move in multiple degrees of freedom. To this end the bearing seat  50  in this embodiment has an interior surface  50   a  that defines a portion of a sphere and includes vertical channels  50   b . In general, the bearing seat  50  retains the bearing  20  and allows partial spherical movement of the bearing  20 . The bearing seat  50  has an open top  52  and an open bottom  54 , and is centered about the common axis α. The open top  52  in this embodiment also forms an opening in the top side  44 , and is concentric with the common axis α. The open bottom  54  opens into the funnel section  56 . 
     The funnel section  56  extends from the top section open bottom  54  of the bearing seat  50  to the top end of the tube seat  60 . The funnel section  56  defines a frustoconical void  68  having an axis on the common axis α. The frustoconical void  68  has a first diameter adjacent the open bottom  54  and converges to its narrow diameter at the top of the tube seat  60 . It will be appreciated that, as with other structures in the interior of the handle  38 , the cone section  56  and the corresponding section of the second cover  38   b  collectively form the entire funnel section  56  that defines the frustoconical void  68 . 
     As shown in  FIGS. 5 and 6 , the controller  12  further includes a concentrator plate  58  having four slots  58   a - 58   d . The concentrator plate  58  is in the form of a disk in this embodiment. The four slots  58   a - 58   d  extend inward from an outer periphery and terminate at locations equidistant from each other, and equidistant from the common axis α. The slots  58   a - 58   d  are configured to receive and guide the wire segments as discussed below. The concentrator plate  58  is received in and secured by features of the second cover  38   b  (and first cover  38   a ) within the funnel section  56 , perpendicular to the common axis α. The inward extents of the four slots  58   a - 58   d  are within the frustoconical section  68 . It will be appreciated that the slots  58   a - 58   d  may be replaced by corresponding throughholes which would also guide the wire segments. 
     As shown in  FIGS. 4, 5 and 6 , the tube seat  60  extends approximately from the bottom  46  to about halfway to the top side  44  terminating at the bottom of the funnel section  56 . The tube seat  60  generally defines a cylindrical interior surface  60   a  that is configured to receive the tube guide  14 , and is concentric with the common axis α. Thus, the center of the bearing seat  50 , the axis of the frustoconical void  68  and the central axis of the cylindrical interior surface  60   a  are axially aligned along the common axis α. 
     The bearing  20  in this embodiment includes a fore-aft yoke  70  and a lateral yoke  72 . The fore-aft yoke  70  includes an outer ring  102  and interior guides  74 ,  80 . The outer ring  102  is partially received and retained with in the channel  50   b  of the bearing  50 . As a consequence, the fore-aft yoke  72  can only rotate fore and aft, constrained by the channel  50   b . The outer ring  102  further comprises hub bores  108  and a plurality of wire holes  110 . The hub bores  108  extend radially through opposite sides of the outer ring  102  at about the vertical midpoint of the outer ring  102 . As will be discussed further below, the hub bores  108  receive the axle  120  of the lateral yoke  72 . The plurality of wire holes  110  are disposed below the hub bores, and are configured to receive the ends of wires therethrough. The outer ring  102  has a discontinuity at its top, forming a void  102   a  for receiving the actuator  18  and allowing movement of the actuator  18 , as will discussed below. The bottom of the outer ring  102  includes a transverse inner groove  102   b.    
     The guides  74 ,  80  cooperate to form a guide channel  112  for receiving a portion of the lateral yoke  72 , as will be discussed below. The guides  74 ,  80  further cooperate to form a shroud to inhibit visual or physical access to the interior of the handle  38  via the open top  52 . The guide  74  includes an arcuate vertical plate  76  and an arcuate lateral plate  78  that are joined at a common edge  75 . The guide  80  similarly includes an arcuate vertical plate  82  and an arcuate lateral plate  84 . 
     The arcuate vertical plates  76 ,  82  are oriented perpendicular to the circumference of the outer ring  102 , and extend in a parallel and arcuate manner from opposite sides of the void  102   a  to locations approximately even with the vertical midlevel of the outer ring  102 . Thus, the arcuate vertical plates  76 ,  82  and the void  102   a  form the guide channel  112 . The arcuate lateral plates  78 ,  84  are likewise oriented perpendicular to the circumference of the outer ring  102 , and are also oriented perpendicular to the vertical plates  76 ,  82 . 
     Each of the arcuate lateral plates  78 ,  84  extends arcuately from approximately the vertical midpoint of the outer ring  102  to the bottom of the respective one of the vertical plates  76 ,  82  at the bottom of the guide channel  112 . It will be appreciated that the radial extent of each of the plates  76 ,  78 ,  82 ,  84  is short of the radial extent of the outer ring  102 , so as to allow the outermost portion of the outer ring  102  to seat within the channel  50   b  within the bearing seat  50  without interference from the plates  76 ,  78 ,  82 ,  84 . 
     The lateral yoke  72  includes a half wheel  118 , an axle  120 . In this embodiment, the lateral yoke  72  is integrally formed with the actuator  18 , forming the rigid connection between the bearing  20  and the actuator  18 . The actuator  18  includes an engagement plate  88  and a connection post  90 . The engagement plate  88  has a top surface  88   a  (see  FIG. 1 ) that is configured to receive an adult human thumb, and may include a convex shape and surface features for friction. The connection post  90  extends from the bottom surface of the plate  88  to the outer surface of the top of the half wheel  118 . 
     The half wheel  118  has a rim  118   a , radial spokes  118   b , and a hub  118   c . The half wheel  118  has the general design of a spoked wheel that has had its bottom half removed. Thus, the rim  118   a  extends about 180 degrees about an axis on which the hub  118   c  is centered. Two of the radial spokes  118   b  form the bottom, with the hub  118   c  disposed therebetween. The rim  118   a  has an outer diameter configured to fit and rotate within the bearing seat  50  and guide channel  112 . The half wheel  118  has an axial width sized to fit (and rotate) within the guide channel  112 , and the transverse inner groove  102   b . The axle  120  extends axially through the hub  118   c  and is rotatably received by the hub bores  108  in the fore-aft yoke  70 . 
     In the rest or default position, shown in  FIGS. 1, 4, and 5 , the connection post  90  extends slight askew (least 10 to 30 degrees) of the common axis α. The engagement plate  88  is disposed perpendicular to the connection post  90 , and thus tilts slightly backward toward the back side  40 . This rest position corresponds to the neutral or center position  30  of the flexible tip  16 . The slight backward tilt of the top surface  88   a  of engagement plate  88  and post  90  in the rest position provides improved ergonomics as compared to being strictly aligned along the common axis α. 
     The yokes  70  and  72  allow for movement of the actuator  18  any of the 360 degrees of position. To this end, the fore-aft yoke  70  allows rotation along the forward and backward dimension, and the yoke  72  allows rotation along lateral dimension, such that combinations of rotations can result in any angle in between. More specifically, the fore-aft yoke  70  is constrained to forward and backward travel by the vertical channels  50   b , and the lateral yolk  72  is constrained to bidirectional lateral travel by the guide channel  112 , and the transverse inner groove  102   b . However, as the yoke  70  rotates, the axle  120  and constraints on the yoke  72  change, such full two-dimensional displacement of the actuator  18  is possible. 
     The two dimensional displacement of the actuator  18  and hence the bearing  20  is translated to the flexible tip  16  via four wire segments  150 ,  152 ,  154  and  156 . The four wire segments  150 ,  152 ,  154  and  156  are operably coupled to the bearing  20  and to the flexible tip  16  to translate the movement of the actuator  18  and bearing  20  to the flexible tip  16 . To this end, two of the wire segments  150 ,  152  are coupled to opposite sides of the outer ring  102  of the fore-aft yoke  70 , and two of the wire segments  154 ,  156  are operably coupled to the opposite sides of the rim  118   a . More specifically, the wire segments  150 ,  152  are coupled to respective locations adjacent to and just below the hub bore  108  on the outer ring  102  (via openings  110 ). The wire segments  154 ,  156  are coupled adjacent to respective radial spokes  118   b  of the half wheel  118 . It will be appreciated that the wire segments  150 ,  152 ,  154  and  156  could be replaced by any other suitable flexible cord. 
     The wire segments  150 ,  152 ,  154  and  156  extend through corresponding slots  58   a - 58   d  in the concentrator plate  58 , and then extend into the hollow interior of the tube guide  104 . The wire segments  150 ,  152 ,  154  and  156  are then operably coupled to the flexible tip  16 . In particular, as shown in  FIGS. 1 to 3 , the flexible tip  16  includes a coupler  180 , a catheter  182 , and a bulbous nub  184 . The wire segments  150 ,  152  in this embodiment form a single continuous wire having ends connected to the fore-aft yoke  70  as described above, and wire body that wraps around the face  184   a  of the nub  184 . Similarly, the wire segments  154 ,  156  in this embodiment form a single continuous wire having ends connected to the lateral yoke  72  as described above, and wire body that also wraps around the face  184   a  of the nub  184 . 
       FIG. 7  shows an exploded view of an exemplary embodiment of the flexible tip  16  in further detail. The catheter  182  forms the flexible tubular member that moves in two degrees of freedom responsive to the movement of the actuator. The catheter  182  in this embodiment is quad-lumen catheter, having separate passages  182   a - 182   d  for each of the wire segments  150 ,  152 ,  154 ,  156 , not shown in  FIG. 7 . The coupler  180  is a polymer device that couples the larger diameter tube guide  14  to the catheter  180 , allowing the wire segments to pass therebetween. The bulbous nub  184  is affixed to the distal end of the catheter  182 , and includes a body  186  having a hollow interior, and end face  184   a  having four openings  188   a - 188   d . The openings  188   a - 188   d  preferably align with passages  182 - 182   d  of the catheter. 
     Although the wire segments  150 ,  152 ,  154  and  156  are omitted from  FIG. 7  for clarity of exposition,  FIG. 7A  shows a fragmentary perspective view of the nub  184  with the wire segments  150 ,  152 ,  154  and  156  assembled thereto. The positions of the wire segments  150 ,  152 ,  154  and  156  is described with contemporaneous reference to  FIGS. 7 and 7A . 
     The wire segment  150 , not shown in  FIG. 7 , extends through the tube guide  16 , the coupler  180 , the passage  182   a  of the catheter  182 , and through the bulbous nub  184 . As shown in  FIG. 7A , the wire segment  150  exits out of the opening  188   a , and ends on the end face  184   a . On the end face  184   a , the wire is essentially both wire segments  150  and  152 . As also shown in  FIG. 7A , the wire segment  152  extends into the opening  188   b . The wire segment  152  further extends through the bulbous nub  184 , through the passage  182   b  of the catheter  182 , through the coupler  180 , and through tube guide  16 . 
     In the same fashion, the wire segment  154 , not shown in  FIG. 7 , extends through the tube guide  16 , the coupler  180 , the passage  182   c  of the catheter  182 , and through the bulbous nub  184 . As shown in  FIG. 7A , the wire segment  154  exits out of the opening  188   c , and ends on the end face  184   a . On the end face  184   a , the wire is essentially both wire segments  154  and  156 . The wire segment  156  extends into the opening  188   d , through the bulbous nub  184 , through the passage  182   d  of the catheter  182 , through the coupler  180 , and through tube guide  16 . It will be appreciated that in other embodiments, the wire segments  150 ,  152 ,  154 ,  156  may be formed of separate wires, each having ends connected to the actuator  20  and to the bulbous nub  184 . 
     In any event, the wire segments the wire segments  150 ,  152 ,  154 ,  156  are relatively taut between the tip  16  and the rotatable bearing  20  when the actuator  18  is in the neutral (e.g. center) position. The ends of the wire segments  150 ,  152 ,  154 ,  156  should be sufficiently engaged at the tip  16  to prevent full sliding movement between the opposing segments of the same wire. 
     In operation, movement of actuator  18  causes rotation of the rotatable bearing  20 . As discussed above, the yokes  70 ,  72  are operably coupled to allow two dimensional rotation of the rotatable bearing. Rotation of the rotatable member  20  pulls on one or two of the wire segments  150 ,  152 ,  154 ,  156  located opposite the direction of the actuator pull. The one or two pulled segments  150 ,  152 ,  154 ,  156  pull at the flexible tip from one direction corresponding to the direction of the pull, thereby causing the flexible tip  16  to flex toward the tension created by the pull. In this manner, movement of the actuator  18  in any combination of front, back, left or right movements creates a corresponding movement in the flexible tip  16  such as those described above in connection with  FIGS. 1, 2 and 3 . 
     Referring again to  FIGS. 4, 5, 6 and 7 , the handle  38  further includes a retainer  62  extending along the common axis externally away from the bottom  46 . The retainer  62  facilitates retention of the endotracheal tube on the introducer  10  during the intubation procedure. The retainer  62  includes a cylindrical portion  64  that aligns with, connects to, and essentially forms a continuation of the tube seat  60 . The retainer  62  also includes a frustoconical portion  66  that extends from the cylindrical portion  64 . In general, the retainer  62  is sized and configured to receive an endotracheal tube, not shown in  FIGS. 4 to 7 , in a friction fit. The tube seat  60 , the cylindrical portion  64 , and the frustoconical portion  66  are aligned to provide a passage for the operative end of the guide tube  14 . As discussed above, the distal end of the guide tube  14  connects to the flexible tip  16 . In this embodiment, the tube guide  14  is hollow, and has a degree of flexibility. 
     In general, the tube guide member  14  and the flexible tip  16  are sized to slidingly receive an endotracheal tube which is commonly used for breathing assistance during anesthesia. To this end,  FIG. 8  shows an endotracheal tube  200  disposed over tube guide  14 , and engaged with the retainer  62 . In this position, the user may insert flexible tip  16 , followed by the tube guide  14  and tube  200 , into the mouth of the patient. The user then can use the actuator  18  to manipulate the position of the tip  16  to help direct the tube guide  14  and tube  200  to the glottic opening of the patient not shown. After the tube  200  is in the proper position, the user may pull the tube  200  off of the connector tip  62  and slide the tube guide  14  and tip  16  out through the tube  200  while the tube remains in place. Once the tube guide  14  and tip  16  are removed from the tube  200 , the operative end of the tube  200  may be connected to assisted respiration equipment. 
     A more specific intubation procedure  300  is described herebelow in connection with  FIG. 9 . In step  305 , a video laryngoscope, not shown, but which is known in the art, is placed in the mouth of the patient. In step  310 , the physician uses the video laryngoscope to find a view of the vocal cords of the patient. In step  315 , an assistant may then hold the video laryngoscope in place while the physician advances the introducer (i.e. stylet)  10  with a preloaded endotracheal tube  200 , as shown in  FIG. 8 , into the mouth and to the posterior pharynx. 
     Thereafter in step  320 , the physician then uses the actuator  18 , which in this embodiment is thumb-controlled, to direct the tip  16  of stylet  10  in any direction  22 ,  24 ,  26 ,  28  or directions intermediate thereof to facilitate movement of the tip  16  towards the glottic opening (vocal cords). Once flexible tip  16  is at the glottic opening, the physician in step  325  advances the introducer  10  through opening into the trachea of the patient. 
     The physician then, step  330 , pulls the endotracheal tube  200  off of the retainer  62 .  FIGS. 10 and 11  show fragmentary views of the endotracheal tube  200  and introducer  10 .  FIG. 10  shows the endotracheal tube  200  affixed to the introducer  10 , and  FIG. 11  shows the operative end of the endotracheal tube  200  taken off the retainer  62  in the process of separation of step  330 . The endotracheal tube  200  may then be advanced along the guide  14  and over the tip  16  through the glottic opening into the trachea. 
     Thereafter, in step  335 , the introducer  10  may then be removed. To this end, the user slides the introducer  10  back up through the operative end of the endotracheal tube  200 . In step  340 , the endotracheal tube  200  is connected to standard respiratory assistance equipment, which is known on the art. 
       FIG. 12  shows a plan view of an alternative embodiment of the controller  12 ′. Specifically, the controller includes the handle  38  of  FIGS. 4 to 6 , an alternative actuator, and an alternative bearing  420 .  FIG. 12  shows the controller  12 ′ with the cover  38   a  removed, similar to the view of the controller  12  in  FIG. 4 . The controller  12 ′ may suitably be used with the tube  14  and flexible tip  16  in place of the controller  12 . 
     In this embodiment, the dual yoke configuration of the bearing  20  has been replaced by a ball configuration. The bearing  420  is substantially a ball shape having the upper part  422  of its outer surface forming a sphere section that sized and configured to be retained by, and rotate within, the bearing seat  50 . The bottom part  424  of the ball may be slightly smaller to better accommodate attachment of the wire sections  150 ,  152 ,  154  and  156  thereto. The actuator  418  in this embodiment has a ribbed, dome-shaped upper surface  426 , but may otherwise have a similar structure as the actuator  18 . 
     The simplicity of design of the ball shaped bearing  420  is an advantage, but the lack of rotational constraint (other than the wire tension) may be a disadvantage compared to the bearing  20 . The choice of embodiment will depend on factors of the user&#39;s specific implementation. 
     The above-described embodiments of the introducer  10  are portable, and can be used in an operating room, ambulance, or a battlefield hospital. The tube introducer  10  can be provided as a disposable kit that includes the introducer  10  with a preloaded endotracheal tube  200 . The handle  38  may suitably be constructed from injection molded polymer, and the tube guide  14  formed of a partly flexible polymer tube. 
     It will be appreciated that the above-described embodiments are merely exemplary, and that those of ordinary skill in the art may readily devise their own implementations and modifications that incorporate the principles of the present invention and fall within the spirit and scope thereof.