Abstract:
An extendable intubation device is disclosed that includes a tube assembly having a plurality of elongated tubes. Within the assembly, a base tube is coupled with an extension tube to maintain a continuous fluid pathway along the tube assembly during a fore-and-aft movement of the extension tube relative to the base tube. For example, a portion of the extension tube can be co-axially mounted within the lumen of the base tube. Additional extension tubes can be included. The length and curvature of the extendable intubation device can be manually adjusted by a control unit having at least one control wire. The control wire(s) are attached to the distal end of the most distal extension tube and can be employed to reciprocally move one or more of the extension tubes in a fore-and-aft movement relative to the base tube and/or selectively bend the tube assembly.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention pertains generally to medical devices. More particularly, the present invention pertains to tracheal intubation tubes. The present invention is particularly, but not exclusively, useful as an extendable and steerable intubation tube assembly that can be guided within the respiratory tract and into a patient&#39;s trachea. 
       BACKGROUND OF THE INVENTION 
       [0002]    Intubation is a medical procedure that is used to establish and maintain the patency of a patient&#39;s airway. In nearly all cases, the procedure is performed by inserting the distal end of an intubation tube into the patient&#39;s upper respiratory tract and then carefully advancing the tube through the larynx and into the patient&#39;s trachea. Although tracheal intubation is typically performed through the mouth (orotracheal intubation), it can also be performed through the nose (nasotracheal intubation). 
         [0003]    Tracheal intubation is often employed in emergency rooms under circumstances which require a physician to intubate a difficult patient quickly and without complication. This is no easy task. For one, it is generally desirable to use a large diameter tube to provide as much airflow as possible. This requirement for a relatively large tube can compound the difficulties associated with trying to guide the intubation tube through the twists and turns within the respiratory tract necessary to reach the trachea. 
         [0004]    As indicated above, during an intubation procedure, a relatively large diameter tube must be passed through the somewhat fragile larynx and into the trachea. This procedure must be performed delicately as undesirable complications can result if the airway is scraped or scratched. Generally, during advancement of the intubation tube, certain anatomical features must be identified to avoid entry into the esophagus and establish a correct pathway into the trachea. In fact, one of the biggest complications associated with these procedures is the failure to properly intubate the patient. Once the correct path is identified, it is not always easy to coax a flexible tube onto a desired pathway leading into the trachea. 
         [0005]    In addition to the concerns cited above, substantial differences in the length and shape of the path that must be navigated by the intubation tube exist across the general patient population due to differences in patient height, weight, oral anatomy and age. In this regard, there is rarely time in the emergency room setting to identify and find a preformed intubation tube having a shape and size that perfectly matches a patient. 
         [0006]    In light of the above, it is an object of the present invention to provide an extendable intubation tube that can be controllably guided through the respiratory system and into the trachea. Another object of the present invention is to provide an intubation device having a system to visually assist the user in guiding the device into the trachea. Still another object of the present invention is to provide an extendable intubation tube that can fit a relatively large portion of the general patient population and provide an optimal airway for all patients. Yet another object of the present invention is to provide a Telescopic Intubation Tube and corresponding methods of use which are easy to use, relatively simple to implement, and comparatively cost effective. 
       SUMMARY OF THE INVENTION 
       [0007]    In accordance with the present invention, an extendable intubation device includes a tube assembly having a plurality of elongated tubes. For the intubation device, each tube has a proximal end, a distal end and is formed with a lumen extending between the tube&#39;s distal and proximal ends. Within the assembly, a first tube (base tube) is coupled with an adjacent second tube (extension tube) to maintain a continuous fluid pathway along the tube assembly during a fore-and-aft movement of the extension tube relative to the base tube. For example, in one embodiment, the proximal end of the extension tube can be co-axially mounted within the lumen of the base tube at the base tube&#39;s distal end. On the other hand, when base tubes having relatively small lumens are used (for example, for infants), the extension tube(s) may be mounted, e.g. clipped on, the external surface of the base tube. When an additional tube (e.g. a second extension tube) is included in the assembly, the second extension tube can be coupled with the first extension tube to maintain a continuous fluid pathway along the tube assembly during a fore-and-aft movement of the second extension tube relative to the first extension tube. 
         [0008]    With the tubes assembled, the length of the extendable intubation device can be manually adjusted by a control unit. In more structural detail, the control unit can include at least one control wire(s). The control wire (or each wire when more than one is used) has an end that is attached to the distal end of the most distal extension tube. For the control unit, the wire(s) are sized to be long enough to ensure that the proximal end of each wire remains at an extracorporeal location throughout the intubation procedure. With this arrangement, the control unit can be employed to reciprocally move one or more of the extension tubes in a fore-and-aft movement relative to the base tube. 
         [0009]    For the intubation device, one, some or all of the tubes in the tube assembly can be of a flexible construction such that the flexible tube(s) can bend under the influence of the control unit. With this structure, one or more of the control wire(s) can be manipulated to bend the distal end of the tube assembly and steer the intubation device into a patient&#39;s trachea. For example, a three wire or a four wire configuration may be used. For these configurations, the attachment points for the wires at the distal end of the tube assembly are typically uniformly spaced around the distal tube. 
         [0010]    Also for the present invention, structures can be formed in the tubes to limit, and in some cases prevent, a relative rotation between adjacent tubes in the tube assembly. These structures, or additional structures, can also be used to limit the distal travel of one tube relative to another (i.e. an adjacent, more proximal tube). 
         [0011]    The intubation device can also include an optical assembly to allow a user (e.g. physician) to visually monitor the advancement of the distal end of the tube assembly into the trachea of the patient. For this purpose, the optical assembly can include an optical fiber that extends through the tube assembly. For the optical assembly, the optical fiber has an end that is attached to the distal end of the most distal extension tube. The other end (i.e. the proximal end) of the fiber can be attached to an eyepiece, which remains at an extracorporeal location throughout the intubation procedure. In some implementations, a light source can be provided to introduce light into the optical fiber and illuminate the anatomical portions of the body near the distal end of the tube assembly. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which: 
           [0013]      FIG. 1  is a perspective view of a patient with portions removed to expose the patients upper respiratory tract; shown intubated with an extendable intubation device in accordance with the present invention; 
           [0014]      FIG. 2  is a perspective view of a tube assembly and control unit for use in the extendable intubation device shown in  FIG. 1 ; 
           [0015]      FIG. 3  is a cross sectional view of the tube assembly shown in  FIG. 2  as seen along line  3 - 3  in  FIG. 2 ; 
           [0016]      FIG. 4  is a perspective view of a tube with portions removed to reveal the inner tube wall which includes a keyway formed thereon; 
           [0017]      FIG. 5  is a perspective view of a tube showing a key extending from the outer tube surface for cooperation with the keyway shown in  FIG. 4 ; 
           [0018]      FIG. 6  is a schematic view of an optical assembly having a light, eyepiece and optical fiber; 
           [0019]      FIG. 7  is a perspective view of another embodiment of an intubation device having a base tube and three extension tubes in accordance with the present invention; 
           [0020]      FIG. 8  is a cross sectional view of an intubation device as seen along line  8 - 8  in  FIG. 7  but having a base tube and two extension tubes, shown in the non-extended configuration; 
           [0021]      FIG. 9  is a perspective view of another embodiment of an intubation device having a pre-bent base tube and with the extension tubes in a non-extended configuration; and 
           [0022]      FIG. 10  is a perspective view of intubation device shown in  FIG. 9  illustrating various positions of the extension tubes. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0023]    Referring initially to  FIG. 1 , an extendable intubation device  10  is shown positioned within a patient  12  after an orotracheal intubation of the patient  12 . As shown, the distal end  14  of the device  10  has been positioned in the trachea  16  of the patient.  FIG. 1  further shows that the device  10  includes a tube assembly  20  that extends from the distal end  14  of the device  10  to a proximal end  22  of the device which remains at an extracorporeal location throughout the intubation procedure. 
         [0024]      FIGS. 2 and 3  show the tube assembly  20  in greater detail. As shown there, the tube assembly can include an elongated base tube  24  and elongated extension tubes  26 ,  28 . Although the device  10  that is shown in  FIGS. 1-3  is illustrated as having three tubes, it is to be appreciated that more than three tubes and as few as two tubes (i.e. a base tube and one extension tube) may be used for the extendable intubation device described herein. 
         [0025]      FIGS. 2 and 3  further show that the base tube  24  has a proximal end  30 , a distal end  32  and is formed with a lumen  34  extending between the distal end  32  and proximal end  30 . Similarly, extension tube  26  has a proximal end  36 , a distal end  38  and is formed with a lumen  40  extending between the distal end  38  and proximal end  36  and extension tube  28  has a proximal end  42 , a distal end  44  and is formed with a lumen  46  extending between the distal end  44  and proximal end  42 . 
         [0026]    Continuing with reference to  FIGS. 2 and 3 , it can be seen that the tubes  24 ,  26 ,  28  in the tube assembly  20  are telescopically arranged. Specifically, as shown, tubes  24 ,  26 ,  28  are each cylindrically shaped and are each centered on common axis  48  with the proximal end  42  of the extension tube  28  co-axially mounted within the lumen  40  of extension tube  26  at the distal end  38  of extension tube  26 . Similarly, the proximal end  36  of the extension tube  26  is co-axially mounted within the lumen  34  of base tube  24  at the distal end  32  of base tube  24 . 
         [0027]      FIGS. 1-3  also show that the distal most tube (i.e. tube  28 ) is typically formed with a beveled tip making it easier to pass through the vocal cords. Each tube in the tube assembly  20  can be made of the same material and wall thickness, or, the tube thickness and tube material may vary among the tubes. For example, one or more of the extension tubes  26 ,  28  may be more flexible than the base tube  24 , either by material selection, wall thickness or both. In one arrangement, the base tube  24  is made to be rigid enough to allow the user to insert the tube through the mouth/nose and into the larynx while the extension tube(s) are flexible. For some implementations, the length of each extension tube  26 ,  28  may be in the range of about 3-5 cm. Generally, the base tube  24  may be longer than the extension tubes  26 ,  28 , as shown in  FIG. 1 . Tube materials can include but are not necessarily limited to polyvinyl chloride, silicone rubber, latex rubber or a metal such as stainless steel. In some cases, one or more of the tubes may be armored to give it strength and flexibility, for example, a spiral of wire may be embedded into the wall of the tube. For some applications, the tube assembly  20  can include a standard cuff, such as a balloon (not shown) affixed to the distal extension tube  28 . 
         [0028]      FIGS. 1-3  show that the overall length of the tube assembly  20  can be manually adjusted by a control unit having one or more control wires  50   a - e.  Although embodiments are shown having two wires ( FIG. 1 ) and four wires 
         [0029]    ( FIGS. 2 and 3 ), it to be appreciated that more than four and as few as one control wire may be used in the extendable intubation devices disclosed herein. For the embodiments shown, the control wires  50   a - e  can be relatively stiff and made of a metal such as stainless steel. 
         [0030]    As best seen in  FIG. 3 , each control wire  50   d,e  has a respective end  52   a,b  that is attached to the distal end  44  of the most distal extension tube  28 . Typically, as shown, the attachment points for the wires  50   d,e  at the distal end  44  of the tube  28  are uniformly spaced around the extension tube  28 . 
         [0031]    Additionally, a wire (not shown) may be attached to the distal end  38  of the intermediate extension tube  28 . For the present invention, the technique used to affix the control wire  50   d,e  to the extension tube  28  can be any technique known in the pertinent art for attaching a control wire to a plastic or metal tube such as adhesive bonding, brazing or a mechanical attachment. It can also be seen that the wires  50   d,e  are sized to be long enough to ensure that the proximal end  54   a,b  of each wire  50   d,e  remains at an extracorporeal location throughout the intubation procedure. These proximal ends  54   a,b  can be left free for manipulation by the user. 
         [0032]    Although the control wires  50   d,e  are shown positioned externally to the tube assembly  20 , it is to be appreciated that portions (or all) of each wire may be located within the tube assembly  20  (i.e. the wires  50   d,e  may pass through in the lumens  34 ,  40 ,  46  of the tubes  24 ,  26 ,  28 ). For example, this may allow the extension tube(s) and wires to be extubated while leaving the base tube  24  positioned in the patient. Moreover, as shown, wire guides  56   a,b  may be employed to constrain lateral wire movement. Although one guide  56   a,b  is shown for each wire  50   d,e,  it is to be appreciated that more than one guide  56   a,b  per wire  50   d,e  may be employed and that guides  56   a,b  may be employed on extension tubes  26 ,  28 , or internally when the wires  50   d,e  are passed within the tube assembly  20 . 
         [0033]    With the arrangement described above, the control wires  50   d,e  can be employed to reciprocally move one or more of the extension tubes  26 ,  28  in a fore-and-aft movement relative to the base tube  24 . As indicated above, one, some or all of the tubes  24 ,  26 ,  28  in the tube assembly  20  can be of a flexible construction such that the flexible tube(s) can bend under the influence of the control wires  50   d,e.  With reference to  FIG. 1 , it can be seen one or more of the control wires  50   a,b,  can be manipulated to bend the distal end  14  of the device  10  and steer the distal end  14  into the patient&#39;s trachea  16 . 
         [0034]    Referring now to  FIGS. 3-5 , it can be seen that structures can be provided to limit, and in some cases prevent, a relative rotation between adjacent tubes  24 ,  26 ,  28  in the tube assembly  20  and/or limit the distal travel of an extension tube  26 ,  28 . In greater detail,  FIG. 4  shows a base tube  24  having a keyway  58  formed on the inner wall  60  of the base tube  24 . As shown, the keyway  58  may extend from the proximal end  30  of the extension tube  26  to an end  62  located at a distance from the distal edge  64  of the base tube  24 . Also,  FIG. 5  shows an extension tube  26  having a key  66 , complementary to the keyway  58  shown in  FIG. 4 , formed on the outer wall  68  of the extension tube  26 , for example, near the proximal end  36  of extension tube  26 . In use, the key  66  may be slid into the keyway  58  when the tubes  24 ,  26  are assembled together. The size and positions/length of the key  66  and keyway  58  may be designed to selectively limit relative rotation and/or distal travel of the extension tube  26  relative to the base tube  24 . A similar key/keyway system may be used to limit relative rotation and/or distal travel of the extension tube  28  relative to the extension tube  26 . 
         [0035]    Cross referencing  FIGS. 1 and 6 , it can be seen that the intubation device  10  can also include an optical assembly  69  to allow a user (e.g. physician) to visually monitor the advancement of the distal end  14  of the device  10  into the trachea  16  of the patient  12 . As shown, the optical assembly  69  can include an optical fiber  70  that extends through the tube assembly  20  from the distal end  14  to an eyepiece  72  which remains at an extracorporeal location throughout the intubation procedure.  FIG. 6  shows that a light source  74  can be spliced together with the eyepiece  72  to introduce light into the optical fiber  70  and illuminate the anatomical portions of the body near the distal end  14  of the device  10 . 
         [0036]      FIGS. 7 and 8  show another embodiment of an intubation device  10 ′ having an optical assembly  69 ′ to allow a user (e.g. physician) to visually monitor the advancement of the distal end  14 ′ of the device  10 ′ into the trachea of the patient. As shown, the optical assembly  69 ′ can include a flexible optical fiber  70 ′ that is coiled within the lumens of the tubes  24 ′,  26 ′,  28 ′ and can straighten when the tubes  26 ′,  28 ′ are extended from the base tube  24 ′. As shown, the optical assembly also includes a distal lens  76  and a fiber-optic view finder  78  at the proximal end. Also shown, the distal end of the optical fiber  70 ′ can be affixed to the distal end of the distal most extension tube (i.e. tube  28 ′) using a mounting bracket  80 . 
         [0037]      FIG. 8  also shows that the tubes  24 ′,  26 ′,  28 ′ may be tapered, with each tube  24 ′,  26 ′,  28 ′ having a conical shape with a relatively smaller distal diameter and a relatively larger proximal diameter.  FIG. 7  further shows that the proximal end of each control wire  50 ′ can include an end cap ferrule  82  and can be placed inside a control unit  84  as shown. Typically, the extension tubes  26 ′,  28 ′ are straight when in a relaxed state. As a consequence, the ferrule  82  on each wire  50 ′ is biased toward the control unit  84  and is pulled from the control unit  84  to selectively retract or bend an extension tube  26 ′,  28 ′. For the embodiment shown in  FIG. 7 , the base tube  24 ′ is rigid and pre-bent into a desired configuration, and can be formed with a handle  86  having one or more grips  88  to facilitate insertion into the upper respiratory tract of the patient. 
         [0038]      FIG. 9  shows another embodiment of an intubation device  10 ″ having rigid, pre-bent base tube  24 ″ and handle  86 ′.  FIG. 9  also shows that the device  10 ″ can include an extension tube  26 ″ and indicates, via arrows  90  the movements of the extension tube  26 ″ that are possible including extension, rotation and bending movements.  FIG. 10  illustrates different shapes of the extension tube  26 ″ that are possible. 
         [0039]    The operation of the device  10  can best be appreciated with reference to  FIG. 1 . First, the device  10  is sterilized and assembled as described above. Next, the distal end  14  of the device  10  is inserted into a patient&#39;s nose or mouth and advanced through the upper respiratory tract. In some cases, this advancement can be with the assistance of a conventional laryngoscope (not shown). In other cases, the device is made with a rigid proximal portion  24  to anatomically fill the upper airway. Once in the upper respiratory tract, the optical assembly  69  can be used to visually monitor the advancement of the distal end  14  and identify certain anatomical features to ensure that the device  10  is steered into the trachea  16  rather than the esophagus  92 . These anatomical features can include the vocal chords and/or tracheal rings. Once the correct path is identified, one or more of the control wires  50   a,b  can be manipulated to bend the distal end  14  of the device  10  and steer the intubation device  10  into a patient&#39;s trachea  16 . The device can then be secured to the patient  12  using customary techniques. 
         [0040]    While the particular telescopic intubation tube and corresponding methods of use as herein shown and disclosed in detail are fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that they are merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design herein shown other than as described in the appended claims.