Abstract:
The present invention relates to a tracheal intubation device and method for placing an endotracheal tube within a patient&#39;s trachea. More particularly, the endotracheal tube includes primary and secondary cuffs, in the form of inflatable balloons. A stillette is positioned within the endotracheal tube. The tracheal intubation device includes a guiding mechanism for guiding the stillette and the endotracheal tube within a patent&#39;s body. The guiding mechanism is positioned external to a patient and sized and shaped so as to transmit a signal and to receive a signal indicating the location of the stillette in a patient&#39;s body. After the endotracheal tube is positioned in the oropharynx, inflating the secondary cuff urges the endotracheal tube toward the trachea of a patient.

Description:
FIELD OF THE INVENTION 
   The present invention relates to endotracheal tubes, and more particularly, to a device and method for facilitating the placement of an endotracheal tube within the trachea. 
   BACKGROUND OF THE INVENTION 
   Certain medical conditions can cause a patient&#39;s airway to become blocked, thereby preventing air from passing to the lungs. A commonly used therapy to treat a blocked airway involves inserting an endotracheal tube into the patient&#39;s trachea in order to restore airway patency. The insertion of the endotracheal tube into a patient&#39;s trachea is referred to as tracheal intubation. 
   In a tracheal intubation procedure, the endotracheal tube passes through a patient&#39;s mouth, through the larynx, and into the trachea. Once the endotracheal tube passes the larynx, it is difficult to properly align the tube into the trachea, because the inlets of the trachea and the esophagus are very close to each other, and the endotracheal tube is often inadvertently placed into the esophagus. Such misalignment significantly increases operating time and reduces the efficiency of the medical procedure. Such misalignment can also injure a patient by bruising the trachea and the esophagus tissues. 
   Various methods exist to facilitate the alignment of the endotracheal tube within the trachea. For example, a conventional method used to perform tracheal intubation is by direct laryngoscopy, in which a laryngoscope is used to visualize the patient&#39;s airway. In direct laryngoscopy, the laryngoscope is initially inserted into a patient&#39;s mouth. The patient&#39;s neck is then extended so that the inlet of the trachea can be visualized in order to facilitate the subsequent insertion of the endotracheal tube. Although direct laryngoscopy may be the most commonly used intubation technique, this method is cumbersome and poses a serious risk to patients that have neck injury. 
   SUMMARY OF THE INVENTION 
   The shortcomings and disadvantages of the prior art discussed above are overcome by providing an improved tracheal intubation device, which includes a endotracheal tube for insertion into a patient&#39;s body. More particularly, the endotracheal tube includes a tubular body, and primary and secondary cuffs attached to the tubular body. The secondary cuff is located proximal to the primary cuff. Both the primary cuff and the secondary cuff are inflatable from a collapsed position to an expanded position. As the secondary cuff inflates, the endotracheal tube is moved in an anterior direction toward the inlet of a patient&#39;s trachea. The tracheal intubation device also includes a stillette removably positioned within the tubular body and a guiding mechanism for guiding the stillette and the endotracheal tube within a patent&#39;s body. The guiding mechanism is positioned external to a patient and includes an indicator for indicating the location of the stillette. The guiding mechanism is sized and shaped so as to transmit a signal and to receive a signal indicating the location of the stillette in a patient&#39;s body. 
   A method is also disclosed for positioning the endotracheal tube within a patient&#39;s body. Initially, the endotracheal tube is inserted in a patient&#39;s body until a distal end of the endotracheal tube is positioned adjacent to the junction of the trachea and the esophagus. Then, the endotracheal tube is urged in an anterior direction toward the inlet of the trachea, which can be performed by inflating a secondary cuff on the tube. After the endotracheal tube is pushed toward the inlet of the trachea, the stillette is inserted into the trachea. Once the position of the stillette inside the trachea is confirmed by the guiding mechanism, the endotracheal tube is continually inserted until the distal end of the endotracheal tube is positioned within the trachea. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     For a more complete understanding of the present invention, reference is made to the following Detailed Description of the Invention, considered in conjunction with the accompanying drawings, in which: 
       FIG. 1  is a perspective view of a tracheal intubation device according to the present invention, which includes an endotracheal tube with primary and secondary cuffs, having a metal stillette inserted within the endotracheal tube, and an external guide system; 
       FIG. 2  is a perspective view of the endotracheal tube shown in  FIG. 1 , which shows the primary and secondary cuffs in expanded configurations; 
       FIG. 3  is a schematic view of a patient&#39;s upper airway and the tracheal intubation device shown in  FIG. 1 , which shows the endotracheal tube and the metal stillette aligned with a patient&#39;s mouth, and the external guide system attached to a patient&#39;s neck; 
       FIG. 4  is a schematic view similar to the view shown in  FIG. 3 , where the endotracheal tube and the metal stillette have been advanced into the oropharynx; 
       FIG. 5  is a schematic view similar to that of  FIG. 4 , where the second balloon has been inflated, causing the movement of the endotracheal tube and the metal stillette toward the inlet of the trachea; 
       FIG. 6  is a schematic view similar to that of  FIG. 5 , where the metal stillette has been advanced into the trachea; 
       FIG. 7  is a schematic view similar to that of  FIG. 6 , where the second balloon has been collapsed, and the endotracheal tube has been advanced further into the trachea; and 
       FIG. 8  is a schematic view similar to  FIG. 7 , where the metal stillette has been withdrawn from the patient and the first balloon has been inflated. 
   

   DETAILED DESCRIPTION OF THE INVENTION 
     FIG. 1  illustrates a tracheal intubation device  10  that is used to facilitate ventilation in patients that have blocked airways. The tracheal intubation device  10  includes an endotracheal tube  12 , a metal stillette  14 , and an external guide system  16 . The endotracheal tube  12  includes an elongate tubular body  18  that has a distal end  20  and a proximal end  22 . The tubular body  18  can be made from any flexible material known in the art, such as plastic, silicon, and tygon. 
   With reference to  FIGS. 1 and 2 , the endotracheal tube  12  further includes a primary cuff  24  attached to the tubular body  18  adjacent to the distal end  20  of the tubular body  18 . The primary cuff  24  includes a first inflatable balloon  26 , which extends about the entire circumference of the tubular body  18 . For reasons to be discussed hereinafter, the first balloon  26  is sized and shaped so as to inflate into a fully expanded configuration as shown in  FIG. 2  and to deflate into a fully collapsed configuration as shown in  FIG. 1 . 
   Referring to  FIGS. 1 and 2 , a first inflating conduit  28  is provided for receiving air and vacuum. The first inflating conduit  28  has one end  30  connected to the first balloon  26  and an opposite end  32  connected to a luer lock connector  34 . The first inflating conduit  28  extends through an interior passageway  36  within the tubular body  18 , and includes an exterior portion  38  extending from the interior passageway  36  adjacent the proximal end  22  of the tubular body  18 . The air supplied via the first inflating conduit  28  can be used to inflate the first balloon  26  to its fully expanded configuration as shown in  FIG. 2 , and the vacuum supplied via the first inflating conduit  28  can be used to deflate the first balloon  26  to its fully collapsed configuration as shown in  FIG. 1 . 
   With continued reference to  FIGS. 1 and 2 , the endotracheal tube  12  is also provided with a secondary cuff  40  positioned at a location proximal to the primary cuff  24 . The secondary cuff  40  includes a second inflatable balloon  42 , which is attached to the dorsal section  44  of the tubular body  18  and covers approximately half of the circumference of the tubular body  18 . For reasons to be discussed hereinafter, the second balloon  42  is sized and shaped so as to inflate into a fully expanded configuration as shown in  FIG. 2  and to deflate into a fully collapsed configuration as shown in  FIG. 1 . A second inflating conduit  46  is provided for receiving air and vacuum. The second inflating conduit  46  has one end  48  connected to the second balloon  42  and an opposite end  50  connected to a luer lock connector  52 . The second inflating conduit  46  extends through an interior passageway  54  within the tubular body  18 , and includes an exterior portion  56  extending from the interior passageway  54  adjacent the proximal end  22  of the tubular body  18 . The air supplied via the second inflating conduit  46  can be used to inflate the second balloon  42  to its fully expanded configuration as shown in  FIG. 2 , and the vacuum supplied via the second inflating conduit  46  can be used to deflate the second balloon  42  to its fully collapsed configuration as shown in  FIG. 1 . 
   Referring to  FIG. 1 , the metal stillette  14  is shaped so as to be coaxially received within the tubular body  18  of the endotracheal tube  12 . The metal stillette  14  has a proximal end  58  and an enlarged spherical distal end  60  that has a diameter of about ¼ inch. The metal stillette  14  is covered with plastic or any other suitable biocompatible coating. The metal stillette  14  has a length in a range of from about 2 to about 2.5 feet and a diameter of about ⅛ inch. It should be understood that the above dimensions for the metal stillette  14  are merely exemplary and that the metal stillette  14  can have other dimensions. 
   The external guide system  16  (see FIGS.  1  and  3 - 6 ) is used to identify the position of the endotracheal tube  12  by identifying the location of the stillette  14 , from outside the body using various methods such as, for example, magnetic, electromagnetic, ultrasound, or capacitive sensing. As such, the external guide system  16  comprises an indicator  61  positioned outside the body to detect the position of a stillette. Metal detectors known in the art can be suitably modified for such a purpose. The external guide system  16  could include both a transmitter (not shown) for transmitting a signal and a receiver (not shown) for receiving a signal. A loudspeaker (not shown) and multiple light emitting diodes (LEDs) (not shown) can be provided within the external guide system  16 . A simple magnetic finder, like the type used to find studs in walls, i.e., a swiveling magnetic rod, could even be employed for the external guide system  16 . The finder could be placed at a patient&#39;s throat and the rod would point to the metal stillette  14  when the metal stillette  14  is positioned at the oropharynx. 
   In order to fully understand the advantages of the tracheal intubation device  10 , a brief overview of the throat  62  is discussed below with reference to  FIGS. 3-7 . The structures of the throat  62  include the oropharynx  64 , the trachea  66 , and the esophagus  68 . The oropharynx  64  is located in the rear of the mouth  70 . The trachea  66  and the esophagus  68 , which is located dorsal to the trachea  66 , are situated below the oropharynx  64 . 
   In operation, prior to inserting the endotracheal tube  12  into a patient&#39;s throat  62 , the metal stillette  14  is placed within the endotracheal tube  12  such that the distal end  60  protrudes from the distal end  20  of the tubular body  18  and the proximal end  58  protrudes from the proximal end  22  of the tubular body  18 . The external guide system  16  is positioned at the anterior side of the patient&#39;s neck. The external guide system  16  can be retained in place by a strap around a patient&#39;s neck and can be placed at a 45 degree angle such that the transmitted and received signal of the external guide system  16  can be passed through the trachea  66  without interacting with the esophagus  68 . 
   The next steps, which are illustrated in  FIGS. 3-7 , involve the insertion of the endotracheal tube  12 , along with the metal stillette  14  placed therein, into the throat  62 . With reference to  FIGS. 3 and 4 , the endotracheal tube  12  is guided through the mouth  70  into the oropharynx  64 . Note that in the foregoing step, the first and second balloons  26 ,  42  of the endotracheal tube  12  are both in their fully collapsed configuration in order to facilitate the insertion of the endotracheal tube  12  into the patient. In this position as shown in  FIG. 4 , the distal end  60  of the metal stillette  14  is located adjacent to the junction between the inlet  72  of the trachea  66  and the inlet  74  of the esophagus  68 , while the second balloon  42  is in contact with the posterior wall  76  of the oropharynx  64 . When the endotracheal tube  12  and the metal stillette  14  reach this position, the position is detected by the external guide system  16 . Turning now to  FIG. 5 , the second balloon  42  is fully inflated, via the second inflating conduit  46 , so as to assume its fully expanded configuration. As the second balloon  42  inflates, the contact between the second balloon  42  and the posterior wall  76  of the oropharynx  64  causes the endotracheal tube  12 , along with the metal stillette  14  placed therein, to move in an anterior direction such that the distal end  20  of the tubular body  18  and the distal end  60  of the metal stillette  14  are urged toward the inlet  72  of the trachea and away from the inlet  74  of the esophagus  68 . 
   The external guide system  16  can be used to align the metal stillette  14  toward the inlet  72  of the trachea  66  in the following manner. As previously indicated, the external guide system  16  senses the position of the metal stillette  14 . The external guide system  16  may emit a signal that passes through the trachea  66  and receives a signal that can be presented in the form of an audio and/or visual signal, which is used to determine the position of the metal stillette  14 . The intensity of the signal received by the external guide system  16  is indirectly proportional to the distance between the metal stillette  14  and the signal emitted by the external guide system  16 ; the intensity of the signal received by the external guide system  16  increases as the metal stillette  14  moves closer to the signal emitted by the external guide system  16 . If the metal stillette  14  is properly aligned with the inlet  72  of the trachea  66 , the intensity of the received audio signal will increase. This can be indicated by an audio or visual signal, which can appear on a display (not shown). If the metal stillette  14  is not properly aligned with the inlet  72  of the trachea  66  and is inadvertently advanced toward the esophagus  68 , the intensity of the received audio signal will decrease or become nonexistent, and/or the visual signal may not appear on the display. The absence of an audio signal or a visual signal will indicate incorrect placement of the metal stillette  14 , such as in the esophagus  68 . If improperly placed, the metal stillette  14  can then be manually moved to achieve proper alignment with the trachea  66 . 
   Once proper alignment between the metal stillette  14  and the inlet  72  of the trachea  66  has been achieved, the metal stillette  14  is manually pushed forward such that the distal end  60  of the metal stillette is advanced into the trachea  66  through the vocal cords, as shown in  FIG. 6 . The external guide system  16  can be used to confirm that the metal stillette  14  has been placed into the trachea  66 . Once the metal stillette  14  is placed into the trachea  66 , the second balloon  42  is deflated into its collapsed configuration. Turning now to  FIG. 7 , the endotracheal tube  12  is then pushed forward so as to advance toward the distal end  60  of the metal stillette  14 , which is positioned in the trachea  66 . Next, the metal stillette  14  is pulled out of the endotracheal tube  12  and withdrawn from the patient, as shown in  FIG. 8 . The first balloon  26  is inflated, via the first inflating conduit  28 , so as to assume its fully expanded configuration. When expanded, the first balloon  26  serves to produce an air-tight seal in order to prevent upper airway obstruction and to prevent secretions from entering the lower tracheal regions. 
   It should be noted that numerous advantages are provided by the tracheal intubation device  10  of the present invention, and the above-described use of same to align the endotracheal tube  12  within the trachea  66 . For example, the second balloon  42  is utilized to align the endotracheal tube  12  with the inlet  72  of the trachea  66 . The external guide system  16  eliminates the need for a laryngoscope and the risks associated therewith. The metal stillette  42  provides rigidity to the endotracheal tube  12 . Accordingly, the second balloon  42  and the external guide system  16  each simplify the complicated task of aligning the endotracheal tube  12  within the trachea  66 . It should be understood that the present invention may be used to place the endotracheal tube  12  within the trachea  66  with the aid of the external guide system  16 , without the need to use the second balloon  42 . Likewise, the second balloon  42  can be used to move the endotracheal tube  12  toward the trachea  66 , without the need to use the external guide system  16 . The endotracheal tube  12  can even be placed in the trachea  66  without the need to use the metal stillette  14 . 
   It will be understood that the embodiment described herein is merely exemplary and that a person skilled in the art may make many variations and modifications without departing from the spirit and scope of the invention. For example, fluid rather than air can be used to inflate the first and second balloons  26 ,  42 . The second balloon  42  could even be replaced with a mechanical device that expands a dorsal area of the endotracheal tube  12  when actuated. The second balloon  42  may employ the use of markers (not shown), such as radio-opaque markers. All such variations and modifications are intended to be included within the scope of the invention as defined in the appended claims.