Patent Publication Number: US-2013245372-A1

Title: Endotracheal intubation assistance apparatus

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims priority of Taiwanese Application No. 101108479, filed on Mar. 13, 2012. 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to a medical instrument, and more particularly to an endotracheal intubation assistance apparatus that has a simple structure, a low cost, and a high clinical applicability. 
     2. Description of the Related Art 
     It is important for endotracheal intubation to be performed in a safety and quick manner. Otherwise, teeth or laryngeal tissue of the patient may be hurt, or an endotracheal tube is inserted erroneously into the esophagus disposed behind the trachea, thereby resulting in occurrence of severe complications, such as hypoxia. 
     Referring to  FIG. 1 , a conventional endotracheal tube  10  is associated with a standard stylet  20 . The endotracheal tube  10  includes a tube body  101  having a predetermined curvature and flexibility, a distal end  102 , a proximal end  103 , a connector  104  sleeved on the proximal end  103 , and an inflatable cuff  105  adjacent to the distal end  102 . The standard stylet  20  can be shaped manually to change the curvature of the endotracheal tube  10  (i.e., the angle of the distal end  102 ). When the angle is not correct, it is necessary to draw an assembly of the endotracheal tube  10  and the standard stylet  20  out of the mouth of the patient for shape adjustment. Upon the completion of the shape adjustment to align the distal end  102  with the vocal cords of the patient, the endotracheal tube  10  is inserted into the trachea. 
     The standard stylet  20  may be replaced with a bougie having a greater length, or a lightwand, as disclosed in US NO. 20080017195. A leading end of the bougie or the lightwand is inserted into the trachea. Under guide of the bougie or the lightwand, the endotracheal tube can be passed fully through the opening defined by the vocal cords. However, the medical personnel must have the related experience and skill. Furthermore, such an endotracheal intubation device may not be suitable for patients more difficult to intubate. 
     U.S. Pat. Nos. 3,802,440, 4,949,716, 5,259,377, and 5,791,338 disclose various auxiliary devices for adjusting the curvature of the endotracheal tube, each of which includes a movable stylet and a control mechanism for activating the movable stylet in a manner more efficient than the above-mentioned manual shaping manner. 
     To perform the above intubation procedures, a blade of a laryngoscope (e.g., disclosed in U.S. Pat. No. 3,638,644) is required to press against the tongue of the patient for allowing light to be emitted into the throat of the patient. However, if the mouth of the patient cannot open to a larger extent, it is difficult to put the laryngoscope into the mouth. Or, although the laryngoscope can be inserted into the mouth, the throat of the patient cannot be seen clearly by the medical personnel. In this case, blind intubation may be tried. 
     U.S. Pat. Nos. 3,669,098, 5,327,881, 6,319,195, 6,539,942, 7,458,375, and US Pub. No. 2008/0236575 disclose a viewing device that is built in a movable stylet. The viewing device is configured as an optical fiber assembly or a small video camera, and is used with an ocular or display for showing images. This can eliminate the use of a bulky laryngoscope to reduce anatomical distortion, and can perform real time observation of the vocal cords. In this manner, leading ends of the movable stylet and the endotracheal tube can be moved into the proximity of the vocal cords, followed by inserting only the endotracheal tube into the trachea. However, in a situation where the opening defined by the vocal cords is small, when anatomical distortion or the throat swelling occurs, or when the cough reflex is triggered, the resistance makes the movable stylet deformed and difficult to manipulate. Furthermore, if the angle formed between the longitudinal directions of the distal end of endotracheal tube and the trachea is too large, it is also difficult to intubate. 
     Since the movable stylet typically has a complex structure, and cooperates with the viewing device to form one piece, such a one piece structure would not be designed to be disposable. 
     To overcome the blind condition of the bougie or the lightwand, U.S. Pat. No. 6,978,784 and US Pub. No. 2007/0175482 disclose a viewing device that permits an endotracheal tube to be sleeved thereon and that can serve as a guide device. The viewing device is first inserted into the trachea. Subsequently, the endotracheal tube is also inserted into the trachea along the viewing device. For awake and obedient patients, such an endotracheal intubation process has been considered to be a current gold standard. However, the stiffness and maneuverability of the viewing device are not sufficient, so that the skill standard of the medical personnel for performing such endotracheal intubation process is relatively high. U.S. Pat. No. 6,257,236 discloses a bronchoscope for facilitating insertion of a stylet into the trachea to allow an endotracheal tube to be sleeved on the stylet and then pushed into the trachea. However, the stiffness and maneuverability of the bronchoscope are also not sufficient. U.S. Pat. No. 6,508,757 discloses a malleable material that is sleeved on a viewing device to increase the stiffness of the viewing device. However, for angle adjustment, removing an assembly of the viewing device and the malleable material from the mouth may be needed, as required by the standard stylet. U.S. Pat. No. 6,146,402 discloses a guide tube introducer for facilitating a guide wire to be placed into the trachea. However, the guide tube introducer is not malleable and flexible, and cannot be preloaded with an endotracheal tube due to the fact that the guide tube introducer must be removed prior to mounting the endotracheal tube. 
     SUMMARY OF THE INVENTION 
     The object of this invention is to provide an endotracheal intubation assistance apparatus that has a simple structure, a low cost, and a high clinical applicability. 
     According to this invention, an endotracheal intubation assistance apparatus is adapted to assist in insertion of an endotracheal tube into the trachea of a patient, and includes a movable tubular stylet, a graspable controller, and a viewing device. The stylet has a leading section, a body section, a tail section, and two slits extending through the body section and the tail section. The tail section is divided by the slits into first and second driven sheets. The viewing device includes an elongate body and a viewing head. The elongate body and the viewing head are movable through the graspable controller, and are extendable outwardly from the leading section. When the first and second driven sheets move relative to each other, the leading section swing synchronously a distal end of the endotracheal tube and the viewing head. 
     By controlling relative movement between the first and second driven sheets, the leading section can swing the distal end of the endotracheal tube and the viewing head synchronously therewith, so as to allow the elongate body to move toward the trachea by a predetermined distance for guiding the endotracheal tube to move toward the trachea along the elongate body. In this manner, the success rate of endotracheal intubation can be promoted effectively, and intubation time period can be reduced. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other features and advantages of this invention will become apparent in the following detailed description of a preferred embodiment of this invention, with reference to the accompanying drawings, in which: 
         FIG. 1  is a schematic side view of a conventional assembly of an endotracheal tube and a standard stylet; 
         FIG. 2  is a schematic view of the preferred embodiment of an endotracheal intubation assistance apparatus according to this invention, illustrating that a leading section of a movable tubular stylet and a distal end of an endotracheal tube are located adjacent to the vocal cords; 
         FIG. 3  is a perspective view of the movable tubular stylet of the preferred embodiment; 
         FIG. 4  is a sectional view of the movable tubular stylet of the preferred embodiment; 
         FIG. 5  is a fragmentary perspective view of the preferred embodiment, illustrating a graspable controller, the movable tubular stylet, and a viewing device; 
         FIG. 6  is a sectional view of the preferred embodiment; 
         FIG. 7  is a fragmentary sectional view of the preferred embodiment, illustrating connection between a driving device of the graspable controller and the movable tubular stylet; 
         FIG. 8  is a fragmentary exploded perspective view of the preferred embodiment; 
         FIG. 9  is a partially sectional view of the preferred embodiment, illustrating a retaining position of a retaining plate of the graspable controller; 
         FIG. 10  is a fragmentary perspective view of the preferred embodiment, illustrating an elongate body and a viewing head of the viewing device; 
         FIG. 11  is a schematic view of the preferred embodiment, illustrating operation of an operating member of the graspable controller and the movable tubular stylet; 
         FIG. 12  is view similar to  FIG. 9  but illustrating a release position of the retaining plate; 
         FIG. 13  is a schematic view of the preferred embodiment, illustrating that the elongate body of the viewing device is inserted into the trachea; 
         FIG. 14  is a schematic view of the preferred embodiment, illustrating that the endotracheal tube and the movable tubular stylet are inserted into the trachea along the elongate body; and 
         FIG. 15  is a schematic view of the preferred embodiment, illustrating that the movable tubular stylet and the viewing device are removed, and only the endotracheal tube is left in the trachea. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring to  FIGS. 2 ,  3 , and  4 , the first preferred embodiment of an endotracheal intubation assistance apparatus according to this invention is adapted to assist in insertion of an endotracheal tube  1  into the trachea (T) of a patient. The endotracheal tube  1  includes a tube body  11  having a predetermined curvature and flexibility, a distal end  12 , a proximal end  13 , and a connector  14  sleeved on the proximal end  13 . Alternatively, the connector  14  may be omitted from the endotracheal tube  1 . The endotracheal intubation assistance apparatus includes a movable tubular stylet  2 , a graspable controller  3 , and a viewing device  4 . 
     The movable tubular stylet  2  is flexible, and has a leading section  21 , a tail section  23 , a body section  22  connected between the leading section  21  and the tail section  23  along the length (L) of the movable tubular stylet  2 , and two slits  24  extending through the body section  22  and the tail section  23 . The movable tubular stylet  2  is formed from a plastic material (such as Teflon) as one piece. The leading section  21  and the body section  22  are adapted to extend in the tube body  11  of the endotracheal tube  1 . With additional reference to  FIG. 6 , the leading section  21  is configured as a cylinder  211  having an inner bore  212 , and a leading end  213  extending outwardly from the distal end  12  of the endotracheal tube  1  and having a chamfered outer periphery  214 . 
     The body section  22  is divided by the slits  24  into a first strip  221  and a second strip  222 . Each of the first and second strips  221 ,  222  has a weakened area  223  adjacent to the leading section  21 , and an action area  224  disposed between the weakened area  223  and the tail section  23  and having a cross sectional area greater than that of the weakened area  223 . 
     The tail section  23  is divided by the slits  24  into a first driven sheet  231  connected to the first strip  221 , and a second driven sheet  232  connected to the second strip  222 . The first and second driven sheets  231 ,  232  are provided respectively with first and second racks  233 ,  234  extending along the length (L) of the movable tubular stylet  2 . In this embodiment, the first and second driven sheets  231 ,  232  of the tail section  23  are formed respectively and integrally with the first and second strips  221 ,  222  of the body section  22 . Alternatively, the first and second driven sheets  231 ,  232  are made of a rigid material different from that of the first and second strips  221 ,  222 , such as metal, and are connected to the first and second strips  221 ,  222 , respectively. With further reference to  FIGS. 5 and 7 , the graspable controller  3  includes a main body  31 , a sleeve  32  connected to and disposed under the main body  31 , a driving mechanism  33  disposed in the main body  31 , an operating member  34  operable for activating the driving mechanism  33 , an extension grip  35  connected to and extending downwardly from the sleeve  32 , a retaining clamp  36  connected to the extension grip  35 , a rail  37  disposed on the main body  31 , a retaining plate  38  disposed movably on the rail  37  and permitting the viewing device  4  to extend therethrough, and a tubular finger-retaining member  39  connected to a side surface of the extension grip  35  facing away from the retaining clamp  36 . 
     The main body  31  includes a top wall  311 , a surrounding wall  312  connected between the top wall  311  and the sleeve  32 , and a guide tube  313  extending downwardly from the top wall  311  and aligned with the sleeve  32 . 
     The surrounding wall  312  defines a space  314  in spatial communication with the sleeve  32 . The guide tube  313  permits the viewing device  4  to extend therethrough. 
     The sleeve  32  is adapted to be sleeved on the connector  14 , and permits the tail section  23  of the movable tubular stylet  2  to extend therethrough. If the connector  14  is omitted from the endotracheal tube  1 , the sleeve  32  can be sleeved directly on the proximal end  13  of the endotracheal tube  1 . 
     The driving mechanism  33  is disposed in the space  314 , and includes a first driving member  331  connected to the first driven sheet  231 , a second driving member  332  connected to the second driven sheet  232 , and a common gear  333  disposed pivotally on the main body  31 . In this embodiment, each of the first and second driving members  331 ,  332  is configured as a pinion. The guide tube  313  extends between the first and second driving members  331 ,  332 , and has an outer surface in contact with the first and second driven sheets  231 ,  232 , so as to maintain the first and second driven sheets  231 ,  232  to mesh with the first and second driving members  331 ,  332 . 
     The first and second driving members  331 ,  332  are disposed pivotally on the main body  31 , and are located respectively at two sides of the common gear  333 . The first driving member  331  meshes with the common gear  333  and the first rack  233 . The second driving member  332  meshes with the common gear  333  and the second rack  234 . The first and second driving members  331 ,  332  can be driven to move synchronously the first and second driven sheets  231 ,  232  in opposite directions along the length (L) of the movable tubular stylet  2 . 
     The operating member  34  is disposed on and outwardly of the surrounding wall  312 , is connected to the common gear  333 , and is operable for driving rotation of the common gear  333  in two opposite directions. The operating member  34  includes a connecting rod  341 , and a finger ring  342  disposed on an end of the connecting rod  341 . An opposite end of the connecting rod  341  is connected to the common gear  333 . The extension grip  35  and the finger ring  342  of the operating member  34  are located respectively at two sides of the sleeve  32 , and are disposed respectively under the first and second driving members  331 ,  332 . The retaining clamp  36  is disposed on the extension grip  35 , and is located directly under the sleeve  32  for clamping releasably the tube body  11  of the endotracheal tube  1 . 
     With further reference to  FIGS. 8 and 9 , the rail  37  is disposed on the top wall  311  of the main body  31 . The retaining plate  38  is formed with a hole  381  that has a retaining hole portion  382 . 
     With particular reference to  FIGS. 2 ,  8 , and  10 , the viewing device  4  includes a flexible elongate body  41  having a diameter of about 4 mm, a viewing head  42  disposed on a leading end of the elongate body  41  and having a length of about 10 mm, and a display  43  electrically connected to the elongate body  41 . The elongate body  41  extends through the hole  381 , and has a contracted portion  411  engageable with the retaining hole portion  382 . The contacted portion  411  has a cross sectional area smaller than that of the remaining portion of the elongate body  41 . The viewing head  42  includes a small video camera  421  disposed therein, and at least one light-emitting member  422  disposed thereon. Alternatively, the viewing device  4  may be an optical-fiber viewing device. 
     With particular reference to  FIGS. 2 ,  6 , and  11 , the elongate body  41  and the viewing head  42  can be moved in the graspable controller  3  along the length (L) of the movable tubular stylet  2 , and can extend outwardly from the inner bore  212  in the leading section  21 . When the finger ring  342  is pivoted downwardly, the first and second driven sheets  231 ,  232  are moved in opposite directions along the length (L) of the movable tubular stylet  2 . Hence, forces are transmitted to the weakened areas  223  of the first and second strips  221 ,  222  through the action areas  224  of the first and second strips  221 ,  222 , so that the distal end  12  of the endotracheal tube  1  and the viewing head  42  are swung upwardly. When the finger ring  342  is pivoted upwardly, the first and second driven sheets  231 ,  232  are moved in opposite directions along the length (L) of the movable tubular stylet  2 . Hence, forces are transmitted to the weakened areas  223  of the first and second strips  221 ,  222  through the action areas  224  of the first and second strips  221 ,  222 , so that the distal end  12  of the endotracheal tube  1  and the viewing head  42  are swung downwardly. As such, the cylinder  211  of the leading section  21  is sufficiently stiff to support the viewing device  4  and the endotracheal tube  1 , and the weakened areas  223  have an increased flexibility so as to allow the leading section  21  to swing easily. 
     With particular reference to  FIGS. 5 ,  6 ,  9 , and  12 , during use, the retaining plate  38  is movable relative to the elongate body  41  between a release position shown in  FIG. 12 , and a retaining position shown in  FIG. 9 . At the release position, the contracted portion  411  is removed from the retaining hole portion  382  so as to allow for movement of the elongate body  41  relative to the retaining plate  38 . At the retaining position, the contracted portion  411  is engaged within the retaining hole portion  382  so as to prevent movement of the elongate body  41  relative to the retaining plate  38 . In this position, the viewing head  42  is received wholly in the leading section  21  for avoiding accession of the dribble to the viewing head  42 . 
     With particular reference to  FIGS. 2 and 9 , during an endotracheal intubation operation, the retaining plate  38  is first placed at the retaining position. Next, the user holds the graspable controller  3  with one hand in such a manner that, the thumb is inserted into the finger ring  342 , the index finger is inserted into the finger-retaining member  39 , and the remaining three fingers grips the extension grip  35  of the graspable controller  3  and the proximal end  13  of the endotracheal tube  1 . Afterwards, the operating member  34  is operated with the thumb to control the movable tubular stylet  2  to thereby swing the distal end  12  of the endotracheal tube  1  and the viewing head  42  of the viewing device  4  upwardly or downwardly. As soon as the display  43  shows that the viewing head  42  is aligned with the opening defined by the vocal cords (V), the retaining plate  38  is moved to the release position, and the elongate body  41  is pushed with the other hand to move toward the trachea (T) by a predetermined distance, as shown in  FIG. 13 . At this time, the endotracheal tube  1  and the movable tubular stylet  2  are pushed into the trachea (T) along the elongate body  41 , as shown in  FIG. 14 . Finally, the retaining clamp  36  is released, and the movable tubular stylet  2  and the elongate body  41  are drawn out of the endotracheal tube  1  so that the endotracheal tube  1  is left in the trachea (T), thereby completing the endotracheal intubation operation, as shown in  FIG. 15 . 
     To sum up, the endotracheal intubation assistance apparatus of this invention has the following advantages:
     1. Different from the above-mentioned conventional assembly of a movable stylet and a viewing device that cannot move relative to each other, according to this invention, the viewing device  4  can be moved through the graspable controller  3  and the movable tubular stylet  2 , such that both allocation of the vocal cords (V) at the first stage and establishment of a guide into the trachea (T) at the second stage can be achieved with relative ease, thereby promoting effectively the success rate of endotracheal intubation and reducing intubation time period.   2. Since the movable tubular stylet  2  is formed mainly from the plastic material as one piece, and is not formed integrally with the viewing device  4 , an assembly of the movable tubular stylet  2  and the viewing device  4  is made at a low cost, is easy to maintain, repair, and sterilize, and can be designed to be disposable to eliminate the sterilization procedure and cost.   3. The graspable controller  3  is convenient to operate. This can reduce the training time, and can promote clinical applicability.   4. Through the design of the extension grip  35 , the medical personnel can hold firmly the extension grip  35  and the proximal end  13  of the endotracheal tube  1  with one hand. As such, sway of the endotracheal tube  1  and the viewing device  4  would be reduced to improve the reliability of the endotracheal tube  1  and the viewing device  4 .   

     it should be noted that, in this embodiment, the endotracheal tube  1  is inserted into the trachea (T) through the mouth. In alternative embodiments, the endotracheal tube  1  can be inserted into the trachea (T) through the nostril. 
     With this invention thus explained, it is apparent that numerous modifications and variations can be made without departing from the scope and spirit of this invention. It is therefore intended that this invention be limited only as indicated by the appended claims.