Abstract:
An apparatus and associated method for using a meconium removal apparatus, including an endo-tracheal (ET) tube operably coupled to a meconium mover operably coupled to a suction tube. The meconium mover has a sloped portion having an inlet defined thereon. The method includes inserting one end of the ET tube into an infant&#39;s airway; applying suction to the meconium aspirator to draw air into the meconium mover through the side inlet, and controllably closing the inlet to increase suction application to controllably draw meconium fluid in the infant&#39;s airway into the ET tube, while withdrawing the ET tube from the infant&#39;s airway.

Description:
[0001]    This application claims the benefit and priority of U.S. Provisional Application No. 60/373,403, filed Apr. 18, 2002, which is herein incorporated by reference for all purposes. 
     
    
     
       BACKGROUND  
         [0002]    1. Field of Invention  
           [0003]    This invention relates generally to an apparatus and associated method for the removal of meconium from infants.  
           [0004]    2. Related Art  
           [0005]    In the care of newborns, the immediate removal of meconium from the newborn infant&#39;s airway and lungs can mean the difference between a healthy newborn infant and a newborn infant replete with infection, lung damage, and breathing difficulty.  
           [0006]    The removal of meconium from the newborn infant&#39;s air passageway is a time critical procedure, since as soon as the newborn becomes stressed and cries, meconium may be aspirated into the newborn infant&#39;s airway and lungs. To avoid this occurrence the meconium must be removed as soon as possible after birth.  
           [0007]    Unfortunately, using common meconium aspirators wastes critical time by requiring that a crucial connecting step between the endo-tracheal (ET) tube and meconium aspirator occur after the ET tube has been inserted into the newborn infant&#39;s airway and withdrawal of a guidewire or stylet has occurred.  
           [0008]    Since, the physician or clinician cannot remove the guidewire and connect the aspirator alone without wasting even more critical time; the use of most common meconium aspirators requires the services of two medical professionals.  
           [0009]    What is needed therefore is a meconium aspirator that removes the need for the services of more than one medical professional and which saves critical time in the process.  
         SUMMARY  
         [0010]    The present invention provides an apparatus and associated method for removing meconium from the air passageway and lungs of a newborn infant.  
           [0011]    The meconium aspirator of the present invention includes an endo-tracheal (ET) tube, a stylet, a meconium mover and a suction tube. The meconium mover includes a strategically positioned side inlet. The side inlet allows for easy removal of a guidewire after placement of the ET tube and provides a means to regulate suction.  
           [0012]    Advantageously, the ET tube, the stylet, the meconium mover and the suction tube of the present invention are operably coupled together to form the meconium aspirator prior to the insertion of the ET tube into the infant&#39;s airway. A guidewire used to place the ET tube in the newborn&#39;s airway can be removed from the meconium aspirator through the strategically placed side inlet, even while the meconium mover and suction tube are coupled to the ET tube.  
           [0013]    Even while the guide wire is being removed, suction can be applied to the suction tube to draw air into the suction tube through the side inlet. Once the guidewire is removed, the strategically placed side inlet allows a clinician to control suction by closing the side inlet to increase the suction and controllably draw meconium fluid from the infant&#39;s airway and lungs into the suction tube for withdrawal, while at the same time withdrawing the ET tube from the infant&#39;s airway.  
           [0014]    In one aspect of the present invention, an apparatus is provided for removal of meconium from an infant&#39;s airway. The apparatus includes an aspirator having an ET tube operably coupled to a meconium mover with or without an indwelling stylet operably coupled to a suction tube. The meconium mover defines an inlet, which is formed at an angle to a central lumen of the meconium mover.  
           [0015]    In yet another aspect of the invention, a method is provided for using a meconium removal apparatus. The method includes providing a meconium aspirator including an endo-tracheal (ET) tube operably coupled to a meconium mover with or without an indwelling stylet operably coupled to a suction tube. The meconium mover has a sloped portion having an inlet defined thereon. The method also includes inserting one end of the ET tube into an infant&#39;s airway; applying suction to the meconium aspirator to draw air into the meconium mover through the side inlet, and controllably closing the inlet to increase suction application to controllably draw meconium fluid in the infant&#39;s airway into the ET tube, while withdrawing the ET tube from the infant&#39;s airway.  
           [0016]    These and other features and advantages of the present invention will be more readily apparent from the detailed description of the preferred embodiments set forth below taken in conjunction with the accompanying drawings. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0017]    [0017]FIGS. 1A and 1B are simplified side views of the meconium aspirator of the present invention; and  
         [0018]    FIGS.  2 A- 2 C are simplified illustrations of the use of the meconium aspirator with a newborn infant in accordance with the principles of the present invention. 
     
    
     DETAILED DESCRIPTION  
       [0019]    [0019]FIGS. 1A and 1B are simplified side views of a meconium aspirator  100  in accordance with the principles of the present invention. Meconium aspirator  100  is used for meconium removal from an infant&#39;s airway and lungs. Meconium aspirator  100  includes an endo-tracheal (ET) tube  102 , a meconium mover  106  and a suction tube  120 . Endo-tracheal tube  102  has a distal end  102   a  for insertion into an airway of an infant and a proximal end  102   b  disposed outside the airway.  
         [0020]    An adaptor  104  is typically formed on proximal end  102   b  of ET tube  102  to facilitate the coupling of various aspirator type devices thereto. In this embodiment, adaptor  104  is a typically sized and shaped adaptor for operably receiving meconium mover  106  and coupling it to ET tube  102 . Adaptor  104  also provides a means for grasping ET tube  102  so as to pull and remove ET tube  102  from its inserted position in the infant&#39;s airway, by manually gripping adapter  104  and pulling adapter  104  and ET tube  102  away from the infant patient.  
         [0021]    In one embodiment, meconium mover  106  is a tubular shaped device of between about 6 cm to about 9 cm in length. Meconium mover  106  includes an inlet end  106   a , having a first diameter, a sloped portion  114 , and an outlet end  106   b , having a second diameter. Meconium mover  106  also includes a strategically positioned side inlet  107  also referred to as a stylet hole, which provides a passageway to the internal lumen  108  of meconium mover  106 .  
         [0022]    Typically a connection between ET tube proximal end  102   b  and inlet end  106   a  of meconium mover  106  is made through adapter  104 . Generally, inlet end  106   a  is force fit into a receiving portion  110  of adapter  104 . In one embodiment, the inner diameter of inlet end  106   a  may range from between about 10 mm to about 15 mm, while the outside diameter may range from between about 11.5 and about 16.5 mm.  
         [0023]    Outlet end  106   b  of meconium mover  106  can be defined by a reduced diameter portion  112 . Outlet end  106   b  may have an inner diameter which ranges from between about 4.5 mm to about 6.5 mm and an outer diameter which ranges from between 6 mm to about 8 mm. In one embodiment, reduced diameter portion  112  may include barbs or other similar means for allowing plastic tubing to be removably attached thereto.  
         [0024]    Sloped portion  114  provides a transition between inlet end  106   a  and the reduced diameter portion  112 . In one embodiment, as shown in FIG. 1A, sloped portion  114  may be symmetrically formed around centerline  115  of meconium mover  106  to provide a consistently sloped face leading into reduced diameter portion  112 . As shown in FIG. 1B, in an alternative embodiment, sloped portion  114  may be formed of a single sloped face offset from centerline  115  that provides tapering of only one side of the cylindrical tube shaped meconium mover  106  leading to reduced diameter portion  112 . Sloped portion  114  can be made to have a sloped face of between about  10 ° to about  90 ° from centerline  115 .  
         [0025]    Side inlet  107  can be defined as a hole having a centerline  118  and having any suitable diameter, such as a diameter of up to 10 mm, preferably about 7 mm. In one embodiment, side inlet  107  is formed on sloped portion  114 , such that hole centerline  118  forms an angle with centerline  115  of less than 90 degrees, preferably about 45 degrees or less.  
         [0026]    The placement of side inlet  107  at an angle less than  90 ° with centerline  115  removes the abrupt transition created by a hole placed at a  90 ° angle with centerline  115 . The angled placement of side inlet  107  is advantageous for many reasons. For example, the angled placement of side inlet  107  allows for removal of an indwelling guidewire or stylet  202  (FIG. 2A) through meconium mover  106 . This is beneficial in that ET tube  102 , meconium mover  106 , stylet  202  and suction tube  120  can be coupled together prior to the placement of ET tube  102  into the infant&#39;s airway, since the guidewire can be removed through meconium mover  106 . In contrast, most other meconium aspirators require placement of the ET tube alone, removal of the guidewire, then coupling of the aspirator to the ET tube.  
         [0027]    The angled position of side inlet  107  also provides a better ergonomic position for allowing the clinician the ability to properly grasp meconium aspirator  100  and simultaneously cover side inlet  107  with a finger or thumb and thus control the suction through ET tube  102 .  
         [0028]    Suction tube  120  can be coupled to reduced diameter portion  112  in any well-known way, such as by means of a rubber or vinyl fitting  122  that can be force fit over reduced diameter portion  112 . Suction tube  120  is coupled to a source of regulated suction (not shown). In some embodiments, the amount of suction can range from between about 60 mm and about 90 mm of mercury, preferably about 80 mm of mercury.  
         [0029]    When connected, air is drawn into meconium mover  106  via side inlet  107 , and flows to suction tube  120 . At the appropriate moment, the clinician&#39;s finger or thumb can be extended over side inlet  107  to control the amount of air flowing to suction tube  120 . Once covered, suction effects are then realized in the infant&#39;s airway and lungs. In this way, the clinician is able to control aspiration of the meconium fluid from the airway, via ET tube  102  and thus, avoid the full force of suction to the infant&#39;s airway and lungs.  
         [0030]    Each of the components of meconium aspirator  100  may be made of any material suitable for use in the clinical applications of aspirators, such as vinyl plastic and the like. Although some dimensions are disclosed, it should be understood that these dimensions are meant to provide examples and are therefore in no way intended to be limiting.  
         [0031]    FIGS.  2 A- 2 C provide simplified illustrations for using meconium aspirator  100  in accordance with principles of the present invention. As shown in FIG. 2A, prior to use meconium aspirator  100  is fully assembled by a clinician by coupling together each of the components, including ET tube  102 , meconium mover  106  and suction tube  120 . Guidewire  202  is placed within the inner lumen  204  defined by the coupled components. Suction tube  120  is coupled to a suction device  206 .  
         [0032]    As shown in FIG. 2B, after birth, if it us determined that meconium aspiration is necessary, ET tube  120  of meconium aspirator  100  is inserted into the airway of the newly born infant. The clinician grasps meconium mover  106  with one hand, such that the clinician can remove guidewire  202  with the other hand. Once guidewire  202  is removed through side inlet  107 , the clinician can control suction by covering side inlet  107  with a finger or thumb.  
         [0033]    Once suction is applied to the infant&#39;s airway by covering side inlet  107  with a finger or thumb, the clinician simultaneously removes meconium aspirator  100  by pulling ET tube  102  from the infant&#39;s airway as shown in FIG. 2C.  
         [0034]    Since the clinician did not have to use up critical time between inserting ET tube  102  and removing guidewire  202  to couple meconium mover  106  to adaptor  104  of ET tube  102 , a more timely removal of meconium can be achieved.  
         [0035]    Having thus described embodiments of the present invention, persons skilled in the art will recognize that changes may be made in form and detail without departing from the scope of the invention. Thus the invention is limited only by the following claims.