Abstract:
A secure guard for an endotracheal tube includes a base ring, and a short gripper, a long gripper, and an upper lip bar each extending from the base ring. The short gripper and the long gripper each includes a flexible neck extending from the base ring and a gripping portion extending from the flexible neck. Each gripping portion includes a first gripping projection and a second gripping projection forming an opening separated by a gap to permit insertion of the endotracheal tube laterally into the opening. The gripping portions preferably include projections to contact the endotracheal tube and prevent sliding of the tube with respect to the guard. The upper lip bar includes an upper lip bar body and an upper lip adhesive strip coupled to the upper lip bar body. In some embodiments, the secure guard is sized to fit a neonate.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    The invention pertains to the field of neonatal medicine. More particularly, the invention pertains to an endotracheal tube and a guard for an endotracheal tube. 
         [0003]    2. Description of Related Art 
         [0004]    When a neonate needs endotracheal intubation for any medical indication, quick and safe intubation is extremely important. The endotracheal (ET) tube tip needs to be positioned in the trachea above the carina. It is extremely difficult for a physician without intubation experience to properly insert an ET tube the correct distance into a patient the first time without assistance. Placing the ET tube at the carina or into the bronchi can lead to complications such as contralateral lung collapse, pneumothorax, bradycardia, and potentially death. 
         [0005]    In order to prevent the ET tube placement deep into the bronchi, the following conventional methods are adopted: 
         [0006]    1. The ET tube is marked just above the tip of the tube to guide placement of the tube to an optimum depth. The vocal cords should be located at the level of this mark when the tube has been inserted to the optimum depth. 
         [0007]    2. The sum of six and the weight of the neonate in kilograms (kgs) gives the length of the lip level, in centimeters, in order to place the end of the ET tube just above the carina. 
         [0008]    In actual practice, many times the ET tube is inserted too far such that after intubation the neonates have the ET tube in the right main stem bronchi. This often leads to one or more complications such as contralateral lung collapse, pneumothorax, and potentially death without timely intervention. If the ET tube is found to be in an incorrect position by chest x-ray, it is typically adjusted. The ease with which an ET tube can be adjusted depends on how it is secured to the baby&#39;s skin. Accidental extubation can happen during tube readjustment. 
         [0009]    Guards for endotracheal tubes are known in the art. 
         [0010]    U.S. Pat. No. 5,060,647, entitled “Short Self-Adhesive Denture Guard” and issued Jul. 23, 1991 to Wiley et al., discloses a dental guard fittable over a patient&#39;s upper incisors composed of an arcuate plastic tray of about 1.5 inches in length and having in cross-section a U-shape. The dental guard protects the incisors from the levering forces exerted by the laryngoscope blade during intubation and provides the person intubating with an unobstructed view for guiding an endotracheal tube via the pharynx through the vocal cords and into the trachea. 
         [0011]    U.S. Pat. No. 7,866,313, entitled “Oral Airways that Facilitate Tracheal Intubation” and issued Jan. 11, 2011 to Isenberg et al., discloses an oral airway including a first component and a second component adapted to be removably coupled together such that a first guiding surface and a second guiding surface collectively define and encompass an interior passage through the oral airway that is dimensioned to direct a fiber-optic scope or an endotracheal tube extending through the interior passage for tracheal intubation. The first and second components are configured to be decoupled and independently removed from a patient&#39;s mouth without disrupting an endotracheal tube that has been extended through the conduit for tracheal intubation. The first and second components may be maintained in coupled disposition by an interlocking mechanical structure or by magnetism. 
         [0012]    U.S. Patent App. Pub. No. 2009/0255538, entitled “Monolithic Endotracheal Tube Holder”, by Thomson et al., published Oct. 15, 2009 and discloses a device for retaining a medically relevant tube into a proper registration for application of medical treatment to a patient, and more particularly to a flexible holder for positioning of an endotracheal tube. The holder has integrated circumferential guard projections for maintaining optimal flow characteristics of the restrained endotracheal tube. Circumferential guard projections extend both outwardly and inwardly from the endotracheal tube holder and are integral to and monolithically formed with the endotracheal tube holder. The endotracheal tube holder is adaptable to receiving tubes of varying diameters and includes a capture means for allowing insertion and removal of an endotracheal tube through a transverse access port in a side aspect of the holder. The monolithic nature of the endotracheal tube holder design is further enhanced through incorporation of access portals about the holder for allowing routine patient maintenance. 
         [0013]    U.S. Patent App. Pub. No. 2011/0132380, entitled “Mouth Guard”, by Goldsby, published Jun. 9, 2011 and discloses a mouth guard with a top mouth piece for engaging the top teeth and a bottom mouth piece for engaging the bottom teeth. The mouth guard also has a central section with one or more ports for receiving an endotracheal tube, an oral gastric tube, or an oral suction tube. A top portion of the central section is attached to the top mouth piece and a bottom portion of the central section is attached to the bottom mouth piece, or the entire central section is attached to the bottom mouth piece. The top and bottom mouth pieces are interlocking via male engaging members and female recesses. 
       SUMMARY OF THE INVENTION 
       [0014]    The endotracheal tube includes a secure guard and a protection ring. The endotracheal tube inserts into a base ring on the secure guard. A short gripper, a long gripper, and an upper lip bar each extend from the base ring. The short gripper and the long gripper each includes a flexible neck extending from the base ring and a gripping portion extending from the flexible neck. Each gripping portion includes a first gripping projection and a second gripping projection forming an opening separated by a gap to permit encircling and firmly holding the endotracheal tube. The gripping portions preferably include projections to contact the endotracheal tube and prevent sliding of the tube with respect to the guard. The upper lip bar includes an upper lip bar body and an upper lip adhesive strip coupled to the upper lip bar body. In some embodiments, the secure guard is sized to fit a neonate. The protection ridge, a small circumferential plastic projection from the outer surface of the endotracheal tube at the 6 centimeter (cm) level, is positioned below the secure guard and prevents slipping of the secure guard into the neonate&#39;s oropharynx. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]      FIG. 1  shows a top view of a monolithic secure guard including a base ring, a short gripper, a long gripper, and a horizontal upper lip bar with a hydrocolloid gel strip protected by a cover strip in an embodiment of the present invention. 
           [0016]      FIG. 2  shows a side view of the monolithic secure guard of  FIG. 1 . 
           [0017]      FIG. 3   a  shows a front view of the upper lip bar of the monolithic secure guard of  FIG. 1  with the cheek extension hydrocolloid gel strip protected by a cover strip. 
           [0018]      FIG. 3   b  shows a back view of the upper lip bar of  FIG. 3   a.    
           [0019]      FIG. 4  shows the monolithic secure guard of  FIG. 1  with the short gripper encircling an ET tube having a protection ridge at the 6 centimeter (cm) level. 
           [0020]      FIG. 5  shows the monolithic secure guard and ET tube of  FIG. 4  with both the short gripper and the tall gripper encircling the ET tube. 
           [0021]      FIG. 6  shows the monolithic secure guard and ET tube of  FIG. 5  applied to a neonate using the adhesive hydrocolloid gel strips. 
           [0022]      FIG. 7  shows a perspective view of a monolithic secure guard in an embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0023]    The endotracheal tube with the monolithic secure guard preferably prevents endobronchial intubation and assists in quick and safe securing of an endotracheal (ET) tube. Although the endotracheal tube with the monolithic secure guard may be sized for use on any patient, the endotracheal tube with the monolithic secure guard is preferably sized for use on a neonate. A neonate, as used herein, may refer to any newborn human infant, including, but not limited to, full-term infants under one month of age and premature infants. The ET tube preferably has an elevated ridge built in the outer wall at a distance 6 centimeters (cm) from the tip. This elevated ridge prevents accidental slipping of the monolithic secure guard into the neonate&#39;s mouth. ET tubes are conventionally made of polyvinyl chloride (PVC) with a hockey stick shape for insertion. The monolithic secure guard has an upper lip bar. The upper lip bar secures the monolithic secure guard to the upper lip of the patient and is preferably made of soft plastic with an adhesive strip on the surface facing the neonate&#39;s upper lip and extending on to the top of the upper lip bar to form cheek extension strips. The adhesive strip is preferably made of a hydrocolloid gel. A cover strip, which may be a plastic strip of paper, protects the sticky surface of the hydrocolloid gel strip until ready for use. This cover strip with a tab is peeled off to stick the adhesive surface of the gel strip to the skin above the neonate&#39;s upper lip. A cheek extension strip is also used for safe securing of the ET tube. The cheek extension strip includes an adhesive strip that is preferably made of a hydrocolloid gel. 
         [0024]    A base ring is attached to the upper lip bar. This base ring is used to hold the ET tube and forms the base for the two grippers. In some embodiments, the two grippers are a short gripper and a long gripper that are perpendicular grippers extending to grip on opposite sides of the ET tube. In some embodiments, the long gripper is located on the upper lip side and the short gripper is located on the lower lip side. In some embodiments, the long gripper is located on the right cheek side and the short gripper is located on the left cheek side. In some embodiments, each gripper has a narrow flexible base attached to the base ring and a wider top with a circular inner surface with small projections. In some embodiments, the projections are formed monolithically with the gripper bodies. In some embodiments, the projections are made of plastic. In other embodiments, the projections are made of metal. The projections grip the ET tube and prevent it from slipping with respect to the secure guard. In some embodiments, the cover strip on the upper lip bar, facing away from the baby has the ET tube intubation depth formula. 
         [0025]    In some embodiments, the base ring, the horizontal upper lip bar except for the hydrocolloid gel strip and cover strip, the short gripper, the long gripper, and the projections are formed monolithically. In some embodiments, the base ring, the horizontal upper lip bar except for the hydrocolloid gel strip and cover strip, the short gripper, the long gripper, and the projections are formed monolithically of PVC. 
         [0026]    Neonatal size varies significantly based on their gestational age and weight. A measurement of the upper lip distance from the left angle of the mouth to the right angle of the mouth is preferably collected on the baby weighing between 500 grams and 4500 grams prior to the selection and use of the endotracheal tube with the secure guard. In some embodiments, the endotracheal tube with the monolithic secure guard is designed in 4 sizes: 2.5 French (Fr) for a birth weight less than 1 kilogram (kg) and/or a gestational age&lt;28 weeks, 3.0 Fr (a birth weight between 1 and 2 kgs and/or a gestational age 28 to 34 weeks), 3.5 Fr (a birth weight between 2 and 3 kgs and/or a gestational age 34 to 38 weeks), and 4.0 Fr (a birth weight&gt;3 kgs and/or a gestational age&gt;38 weeks). In some embodiments, the ET tube has the monolithic secure guard in place. In some embodiments, the base ring of the secure guard is at the following cm mark based on the size of the ET tube: 8 cm for the 2.5 Fr ET tube, 9 cm for the 3.0 Fr ET tube, 10 cm for the 3.5 Fr ET tube, and 11 cm for the 4.0 Fr ET tube. 
         [0027]      FIG. 1  and  FIG. 2  show a top view and a side view, respectively, of a secure guard  10 . The secure guard includes a base ring  12 . A short gripper  14 , a long gripper  16 , and a horizontal upper lip bar  18  extend from the base ring  12 . The horizontal upper lip bar  18  includes at least one hydrocolloid gel strip  20  protected by at least one cover strip  22 . The secure guard  10  is monolithic in that all but the hydrocolloid gel strip  20  and the cover strip  22  are formed as a single piece of plastic. 
         [0028]    The short gripper  14  includes a flexible neck  24  connecting a gripping portion  26  to the base ring  12 . The gripping portion  26  has a gap  28  to receive an ET tube, a pair of flexible gripper tabs  30 ,  32  to slide laterally around the ET tube, and a plurality of projections  34  extending inwardly from the gripping portion  26  to grip the ET tube. A finger tab  36  extending from the back of the gripper portion  26  aids in removal of the gripper portion  26  from an ET tube by giving the user something to grab or push. 
         [0029]    The long gripper  16  includes a flexible neck  38  connecting a gripping portion  40  to the base ring  12 . The long gripper  16  flexible neck  38  is longer than the short gripper  14  flexible neck  38  such that the long gripper  16  gripping portion  40  grips the ET tube at a position farther from the position of the base ring  12  than where the short gripper  14  gripping portion  26  grips the ET tube. The gripping portion  40  has a gap  42  to receive an ET tube, a pair of flexible tabs  44 ,  46  to slide laterally around the ET tube, and a plurality of projections  48  extending inwardly from the gripping portion  40  to grip the ET tube. A finger tab  50  extending from the back of the gripper portion  40  aids in removal of the gripper portion  40  from an ET tube by giving the user something to grab or push. 
         [0030]      FIG. 3   a  and  FIG. 3   b  show a front view and a back view, respectively, of the upper lip bar  18 . The upper lip bar body  52  extends from the base ring and the adhesive strips  20 ,  54  are affixed to the upper lip bar body  52 . To apply the upper lip bar  18  to the neonate, the upper lip cover strip  22  is removed from the upper lip hydrocolloid gel strip  54 , and the upper lip hydrocolloid gel strip  54  is pressed against the skin above the upper lip of the neonate to adhere. The tabbed cheek extension cover strip  56  is then removed from the slotted cheek extension cover strip  58  and the strips  56 ,  58  are pulled outward to the sides to expose the cheek extension hydrocolloid gel strips  20 , which adhere to the cheeks of the neonate to provide additional adhesion between the device and the neonate. 
         [0031]      FIG. 4  shows an ET tube  60  with a protection ridge  62  at the 6 centimeter (cm) level. The ET tube  60  has been inserted into the base ring  12  of the secure guard  10  with the short gripper  14  encircling the ET tube  60 .  FIG. 5  shows the tall gripper  16  also encircling the ET tube  60  such that the secure guard  10  has fully secured the ET tube  60 . As shown in  FIG. 5 , the short gripper  14  and the long gripper  16  are on opposite ends of the base ring  12  facing each other such that the neck of the long gripper  16  goes over and contacts the end portions of the flexible gripper tabs  30 ,  32  of the short gripper  14  to provide additional support to the short gripper  14 .  FIG. 1  shows the opening  17  on the neck of the long gripper  16  into which the ends of the flexible gripper tabs  30 ,  32  of the short gripper  14  extend. In  FIG. 6 , the ET tube  60 , with the secure guard  10  applied to the ET tube  60 , has been inserted into the airway of a neonate  70 , with the upper lip hydrocolloid gel strip  54  and the cheek extension hydrocolloid gel strips  20  applied to the skin of the neonate  70 . 
         [0032]    The following are the preferred steps involved in securing the ET tube with a monolithic secure guard: 
         [0033]    1. Determine or guess the weight of the baby and choose the appropriate size ET tube with the secure guard in place. 
         [0034]    2. As soon as the neonate is intubated to the desired level, the long and short gripper are ungripped from the endotracheal tube, the plastic paper covering the adhesive surface of the hydrocolloid strip facing the upper lip is removed, the secure guard is adjusted based on the intubation formula shown on the upper lip bar, and the horizontal upper lip bar is stuck to the neonate&#39;s skin above the upper lip. 
         [0035]    3. The plastic paper covering the adhesive strip of the hydrocolloid strip facing away from the upper lip is removed and the cheek extension adhesive strips are attached to the cheeks. 
         [0036]    4. The ET tube is adjusted based on the weight of the baby by detaching the short and tall gripper from the ET tube. The ET tube is adjusted, and the short gripper and tall gripper are reattached after the ET tube adjustment has been made. 
         [0037]    The following safety precautions are preferably taken: 
         [0038]    1. To prevent the accidental dislodging and aspiration of the secure guard, the horizontal upper lip bar is made wider than the mouth, the secure guard is made with a single plastic piece, and the prominent ridge embedded to the wall of the ET tube at 6 cm level prevents accidental slippage of the secure guard. 
         [0039]    2. To avoid masking the ET tube markings, the monolithic secure guard is made of a transparent plastic. 
         [0040]      FIG. 7  shows a three-dimensional perspective view of a monolithic secure guard without the hydrocolloid gel strips. The piece shown in  FIG. 7  is preferably formed monolithically as a single integral piece from a mold.  FIG. 7  shows the horizontal upper lip bar  18  having a shape with ends curving toward the neonate&#39;s upper lip. The horizontal upper lip bar  18  extends integrally from the top of the base ring  12 . The short gripper  14  and the long gripper  16  extend from the left and right sides, respectively, of the base ring  12  in a direction substantially perpendicularly to the base ring  12  and the horizontal upper lip bar  18  and substantially parallel to each other. The short gripper and long gripper may alternatively extend from the right and left sides, respectively, of the base ring. 
         [0041]      FIG. 7  also shows grooves on the tops of the finger tab  36 ,  50  to provide a gripping surface for the finger when disengaging the gripping portions  26 ,  40  from the endotracheal tube. The projections  34 ,  48  extend longitudinally as ridges in the gripping portions  26 ,  40 , respectfully, in  FIG. 7 . The flexible gripper tabs  30 ,  32  on the short gripper  14  are designed to extend through the opening  17  on the neck of the long gripper  16 , with extensions on the outer surfaces of the tabs  30 ,  32  to help maintain engagement with the neck of the long gripper  16 . 
         [0042]    The endotracheal tube with the secure guard may also be adapted for intubation through the nasal route, for example, by using an ET tube without a protection ridge at 6 cm level and locating the base ring at a little higher level than the horizontal upper lip bar. 
         [0043]    The endotracheal tube with the secure guard may be tailored to be used in pediatric and adult humans, and small to medium sized pets, while performing endotracheal intubation. 
         [0044]    Accordingly, it is to be understood that the embodiments of the invention herein described are merely illustrative of the application of the principles of the invention. Reference herein to details of the illustrated embodiments is not intended to limit the scope of the claims, which themselves recite those features regarded as essential to the invention.