Intubation Devices

Abstract

A stylet is disclosed for insertion into an endotracheal tube for guiding the tube during intubation. The stylet has a body (3) with a pivotable tip portion (5) at its distal end which is movable in either of two opposing directions away from the axis of the stylet. The tip portion (5) may carry an image acquisition device for video imaging. A control mechanism for controlling the pivot angle of the pivotable tip has a hand-operated actuator (7) at the proximal end of the stylet and flexible control wires (23) extending down the stylet to connect the actuator to the pivotable tip portion (5). Also disclosed is an endotracheal tube (100) usable with the stylet and having a bending portion (103), defined by a concertina or thinned portion, at its distal end to facilitate bending of its tip portion (104) by the stylet tip portion (5).

1 - 15 . (canceled) 
     
     
         16 . A stylet device for guiding insertion of an endotracheal tube into a subject's airway, said stylet device comprising:
 an elongate stylet body having a proximal end and a distal end;   a pivotable tip affixed by a hinge to the distal end of the stylet body; and   an actuator at the proximal end of the stylet body;   
       wherein;
 the hinge is configured to allow the tip to pivotally deflect in opposing first and second directions relative to a neutral position, without affecting the shape of the stylet body; and 
 the actuator is useable to operate a control mechanism which controls said pivotal deflection of the tip. 
 
     
     
         17 . A stylet device according to  claim 16  wherein the control mechanism comprises one or more lines or wires. 
     
     
         18 . A stylet device according to  claim 17  wherein the lines or wires are flexible. 
     
     
         19 . A stylet device according to  claim 18  wherein:
 a first portion of flexible line or wire is connected to one side of the pivotable tip and a second portion of flexible line or wire is connected to an opposing side of the tip; and 
 the actuator is useable to alternately i) apply tension to the first portion of flexible line or wire to thereby cause the tip to pivotally deflect in the first direction or ii) apply tension to the second portion of flexible line or wire to thereby cause the tip to pivotally deflect in the second direction. 
 
     
     
         20 . A stylet device according to  claim 19  wherein the first portion of flexible line or wire and second portion of flexible line or wire are parts of a single flexible line or wire. 
     
     
         21 . A stylet device according to  claim 19  wherein the first portion of flexible line or wire and second portion of flexible line or wire are separate flexible lines or wires. 
     
     
         22 . A stylet device according to  claim 16  wherein the tip is pivotable within a pivot angle range of at least ±10°. 
     
     
         23 . A stylet device according to  claim 16  further comprising a lumen which extends through at least a portion of the stylet body. 
     
     
         24 . A stylet device according to  claim 23  further comprising a rod that is insertable into said lumen. 
     
     
         25 . A stylet device according to  claim 24  wherein the lumen has a distal end located at or proximal to the hinge. 
     
     
         26 . A stylet device according to  claim 24  wherein the rod is malleable. 
     
     
         27 . A stylet device according to  claim 24  wherein the rod is configured so as not to be rotatable within the lumen. 
     
     
         28 . A stylet device according to  claim 27  wherein the lumen and the rod have rectangular transverse cross sectional configurations which prevent the rod from rotating within the lumen. 
     
     
         29 . A stylet device according to  claim 27  wherein the rod further comprises a handle on a proximal end of the rod. 
     
     
         30 . A stylet device according to  claim 16  wherein the control mechanism has a plurality of discrete stop points which provide locking of the pivotable tip at discrete incremental pivot angles. 
     
     
         31 . A stylet device according to  claim 16  wherein an actuator comprises a wheel, dial, lever or joystick. 
     
     
         32 . A stylet device according to  claim 16  further comprising an image acquisition device on the tip. 
     
     
         33 . A stylet device according to  claim 32  further comprising a monitor which receives and displays images from said video image acquisition device. 
     
     
         34 . A system comprising a stylet device according to  claim 16  in combination with an endotracheal tube, wherein the stylet device is insertable into the endotracheal tube to a fully inserted position and useable to guide insertion of the endotracheal tube into a patient's airway. 
     
     
         35 . A system according to  claim 34  wherein the stylet has an image acquisition device. 
     
     
         36 . A system according to  claim 35  wherein the image acquisition device is located on the tip. 
     
     
         37 . A system according to  claim 36  wherein the endotracheal tube has a distal end and, when the stylet device is positioned at said fully inserted position, the image acquisition device captures images distal to the distal end of the endotracheal tube. 
     
     
         38 . A system according to  claim 35  wherein the stylet can be withdrawn and removed from the endotracheal tube after the stylet device has been used to guide insertion of the endotracheal tube into the subject's airway. 
     
     
         39 . A system according to  claim 38  wherein the image acquisition device is arranged to capture images in a direction radial to the longitudinal axis of the stylet. 
     
     
         40 . A system according to  claim 34  wherein the endotracheal tube has at least one Murphy eye formed near a distal end of the endotracheal tube and said at least one Murphy eye is configured to prevent the stylet from protruding through said at least one Murphy eye. 
     
     
         41 . A system according to  claim 34  wherein:
 the endotracheal tube has a bending region, a proximal portion located proximal to the bending region and a distal portion located distal to the bending region; and 
 the stylet device is insertable into the endotracheal tube to an operating position wherein the hinge of the stylet device is positioned in relation to the bending region of the endotracheal tube such that pivotal deflection of the tip of the stylet device will cause concurrent deflection of the distal portion of the endotracheal tube. 
 
     
     
         42 . A system according to  claim 41  wherein the bending region has a corrugated configuration. 
     
     
         43 . A system according to  claim 41  wherein the bending region comprises a concertina or accordion segment. 
     
     
         44 . A system according to  claim 41  wherein the endotracheal tube has a wall and wherein a portion of the wall within the bending region is thinner than the remainder of the wall. 
     
     
         45 . A system according to  claim 41  wherein the bending region is made from a different material from the remainder of the endotracheal tube. 
     
     
         46 . A system according to  claim 41  wherein the endotracheal tube further comprises an inflatable cuff and the bending region is located within the inflatable cuff. 
     
     
         47 . A system according to  claim 16  wherein the stylet device has a lumen which extends through at least a portion of the stylet body and a rod that is insertable into and removable from said lumen. 
     
     
         48 . A system according to  claim 47  wherein the rod is malleable. 
     
     
         49 . A system according to  claim 47  wherein:
 the rod is formable to, and will retain, a curved shape; and, thereafter, 
 when the rod is positioned in said lumen of the stylet and the stylet is positioned at said fully inserted position within the endotracheal tube, at least a portion of the stylet body and a corresponding portion of the endotracheal tube will assume a curved shape that corresponds to the curved shape of the rod. 
 
     
     
         50 . A method for using a system according to  claim 34  comprising the steps of:
 inserting the stylet device to said fully inserted position within the endotracheal tube; 
 trans-orally or trans-nasally inserting the stylet device/endotracheal tube combination; 
 using the actuator to cause the stylet tip to deflect in a direction permitted by the hinge, thereby causing corresponding deflection of a distal portion of the endotracheal tube; 
 advancing the endotracheal tube and inserted stylet device through vocal cords and into a trachea of the subject; and 
 removing the stylet device from the endotracheal tube. 
 
     
     
         51 . A method according to  claim 50  wherein the stylet device has an image acquisition device and the method further comprises using the image acquisition device to view images of the subject's anatomy. 
     
     
         52 . A method according to  claim 51  wherein the image acquisition device is used to facilitate advancement of a distal end of the endotracheal tube through vocal cords and into a trachea of the subject. 
     
     
         53 . An endotracheal tube comprising:
 an elongate tube body comprising a tubular wall having a lumen extending therethrough; and   an inflatable cuff through which the tubular wall extends;   wherein the tubular wall comprises a bending portion located within the endotracheal tube cuff.   
     
     
         54 . An endotracheal tube according to  claim 53  wherein the bending portion of the tubular wall has a corrugated configuration. 
     
     
         55 . An endotracheal tube according to  claim 53  wherein the bending portion of the tubular wall comprises a concertina or accordion segment. 
     
     
         56 . An endotracheal tube according to  claim 53  wherein the bending portion of the tubular wall is thinner than the remainder of the tubular wall. 
     
     
         57 . An endotracheal tube according to  claim 53  wherein the bending portion of the tubular wall comprises a different material from the remainder of the tubular wall. 
     
     
         58 . A system comprising an endotracheal tube according to  claim 53  in combination with a stylet having a hinge or bending location and a distal tip which extends distally from the hinge or bending location, wherein:
 the stylet is positionable within the lumen of the endotracheal tube such that the hinge or bending location of the stylet is located within the bending portion of the endotracheal tube.