Abstract:
A neonatal endotracheal tube stabilizer has a tube cradle, a tube fixation element attached to said tube cradle and a stabilization bar having a plurality of engagement elements. The stabilization bar extends on either side of the tube cradle to engage two cheek pads. The cheek pads each have a releasable engagement interface dimensioned to engage the engagement elements of the stabilization rod in at least one engaged position. When so engaged, the cradle firmly holds the endotracheal tube in a position selected by a health care provider.

Description:
RELATED APPLICATIONS 
       [0001]    None 
       BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The invention is in the field of medical devices, particularly position and stabilization equipment for endotracheal tubes. 
         [0004]    2. Related Art 
         [0005]    Few things in medical care are as sensitive and demanding of precision for health care personnel as neonatal intubation. Proper placement of the newborn&#39;s “breathing tube,” ease, speed and accuracy of positioning, removal and replacement are of paramount importance. Accordingly, certain prior art devices have been developed to advance the art past simple taping of the tube to the newborn have been made. However, there remains a need in the art for devices improving ease, speed and accuracy of positioning, placement, removal and replacement of endotracheal tubes for neonates. There is a further need for devices that protect the skin of the child and for equipment that facilitates potential emergent response to changes in the child&#39;s status. 
       SUMMARY OF THE INVENTION 
       [0006]    The neonatal endotracheal tube stabilizer of the present invention has a tube cradle, a tube fixation element attached to said tube cradle and a stabilization bar having a plurality of engagement elements. The stabilization bar extends on either side of the tube cradle to engage two cheek pads. The cheek pads each have a releasable engagement interface dimensioned to engage the engagement elements of the stabilization rod in at least one engaged position. When so engaged, the cradle firmly holds the endotracheal tube in a position selected by a health care provider. 
         [0007]    The engagement designs of both the tube cradle and between the stabilization rod and cheek pads provide for advantageous ease of use, flexibility of placement, and rapidity of release or readjustment. 
         [0008]    Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]      FIG. 1  is the exploded diagram of the endotracheal tube stabilizer of the present invention. 
           [0010]      FIG. 2  is close up perspective view of a cheek pad. 
           [0011]      FIG. 3  is a perspective view of the support bar and tube cradle of the present invention. 
           [0012]      FIG. 4  is a top view of the support bar and tube cradle. 
           [0013]      FIG. 5  is an isometric view of a part of an alternate embodiment. 
           [0014]      FIG. 6  is an isometric view of a part of an alternate cheek pad embodiment. 
           [0015]      FIG. 7  is an isometric view of a part of an alternate cheek pad embodiment. 
           [0016]      FIG. 8  is an isometric view of a part of an alternate embodiment. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0017]    Referring now to the drawings in which like reference numbers indicate like elements,  FIG. 1  is an exploded view of the neonatal endotracheal tube stabilizer of the present invention  10 . The components of the invention include the support bar  12 , the endotracheal tube (“ET Tube”) cradle  14 , two cheek pads  16  and a neck strap  18 . 
         [0018]      FIG. 3  depicts the support bar  12  and tube clamp  14  as assembled. The assembly of the ET Tube cradle  14  with the support bar  12  is by the engagement of ET Tube cradle slot  20  with central detent  22  in the support bar  12 . Detent  22 , as depicted, is substantially U-shaped and oriented downwards. This achieves simultaneously the effect of creating an appropriately dimensioned space for passage of the endotracheal tube, as well as an engagement with the ET Tube cradle  14  that is stable in multiple dimensions. Because the detent  22  is offset from the longitudinal axis of the support bar  12 , which is oriented to be substantially transverse to the air passage or mouth of the patient, the detent  22  further promotes proper positioning of the ET Tube at the desired central position aligned with the patient&#39;s airway. 
         [0019]    The ET Tube cradle  14  includes a concavity  24  on one aspect, which, in the depicted embodiment, opens upwards or towards the patient&#39;s nose. This defines a seat on which the endotracheal tube may rest and be stabilized. The seat/concavity  24  may be equipped with ribs  26  to arrest motion of the ET Tube inwards or outwards by friction when the ET Tube is fixed in position. 
         [0020]    The ET Tube is fixed in its position in the ET Tube cradle  14 , in the depicted embodiment, by means of strap  28 . Strap  28  may be fabricated of elastomeric material having some elasticity. The strap  28  is comprised of a thumb and finger tab  30 , a stretchable ET Tube contact portion  32  and a through hole  34 . In operation, after the tube stabilization device has been properly positioned and the ET Tube inserted into the airway to its proper depth, the strap  28  is stretched slightly outwards, wrapped over the top of the ET Tube on the ET Tube cradle  14  and then hole  34  is engaged with tab  36  to secure it in a locking position when released. The elasticity of the strap  28  serves to hold the hole  34  secure against the tab  36  and create pressure that holds the ET Tube securely in position against both lateral and axial movement relative to the ET Tube cradle  14 . 
         [0021]    In the depicted embodiment the support bar  12  may be fabricated of a malleable, semi-rigid material, for example brass or stainless steel, with an elastomeric over mold. Accordingly, metal rod  40  is covered with the elastomeric material  42 . 
         [0022]    The support bar  12  is made of malleable material so that the left and right wings  44  may be bent around the mouth and cheeks of the patient. An originally straight and malleable configuration allows for ease of manufacturing and customizable shaping for each patient. The elastomeric material over the metal is configured to have at least one and, as depicted, a plurality of engagement elements  46 . In the depicted embodiment these engagement elements  46  are teeth, which may be frustoconical. The depicted teeth are oriented with their narrow end outwards, to promote ease of assembly with the cheek pads  16 . Of note and best seen in  FIG. 4 , the teeth are not fully circumferential around the stabilizing bar  40 . This axially truncated shape  47  further promotes the proper orientation and positioning of the ET Tube cradle  14  relative to the patient&#39;s airway, due to the manner in which the flat side of the teeth engages with the corresponding structure in the cheek pads  16  as more fully described below. 
         [0023]      FIG. 2  depicts the cheek pad  16 . An opposing side of the cheek pad away from view in  FIG. 2  is substantially flat and configured to receive an interfacing material for contact with the patient&#39;s skin, such as an adhesive mole skin backing. The outwardly facing side of the cheek pad  16  includes the following components. A support bar receiving element  50  includes a passage  52  for receiving the support bar  12 . In the depicted embodiment a neck strap post  54  is located on top of the receiving element  50 . The neck strap post  54  is a positive element designed to engage the hole  56  at the end of the neck strap  18  (or any of the intermediate holes in the neck strap) for further tractive stabilization of the overall device. As the name implies, the neck strap  18  stretches from engagement of a left end hole  56  with a left cheek pad neck strap post  54  around the back of the patient&#39;s head to an opposing right side neck strap hole(s)  56  with the corresponding neck strap post  54  on the right cheek pad  16 . 
         [0024]    The bar retainer  58  defines the passage  52  into which the support bar  12  is inserted during assembly on the patient. In the depicted embodiment the receiver portions  58 A and  58 B includes teeth  60  configured and dimensioned to interlock with the spaces between the teeth or engagement elements  46  on the support bar  12 . The teeth  60  on the cheek pad extend circumferentially around the inner surface of the retainer  58 . However, in the depicted embodiment there are no ribs  60  on the surface of the outer planar surface  62  of the cheek pad that is located within the channel  52  for retaining the support bar. Hence the untoothed flat surface  62  matches with the flat lateral truncations  47  of the teeth or locking elements  46  in order to positively align the support bar  12  rotationally, which again promotes positioning of the ET Tube cradle  14  with the desired position aligned with the patient&#39;s airway. In the depicted embodiment the receiver  58  is bifurcated into portions  58   a  and  58   b.  Since the cheek pad  16  as depicted is molded of an elastomeric material, this gives the receiver  58  flexibility so that the teeth  60  may ride up and over the engaging elements  46  upon insertion of the support bar  12 . Once the proper degree of insertion of the support bar  12  through the receiver  58  has been reached for an appropriate custom fit with a particular patient, the elasticity of the receiver wings  58  will bias them inwards towards a retaining, engaged position of teeth  60  with engaging elements  46 . Receiver wings  58   a  and  58   b,  may have a thin portion molded into them, as represented by slot  64 , to engage boss  74  on bar lock  66  and close channel  52  and secure bar  12 . 
         [0025]    Once the support bar  12  has been inserted into the receiver  58  of the cheek pad  16  to an appropriate position, that position may be locked into a holding engagement without further flexion of the receiver  58  by the use of the bar lock  66 . Bar lock  66  is attached to the rest of the cheek pad  16  by a moveable element which, as depicted, may be a hinge  68 . The bar lock  66  includes an encapsulating semicircle  70  dimensioned to fit over the outer surface of the receiver  58 . A finger tab  72  facilitates its actuation by an operator. A boss  74  is dimensioned to engage slot  64  for positive locking into position. A symmetric cheek pad  16  is similarly assembled on the other side of the patient. Extension  76  serves as a finger tab and an end stop against over insertion of support bar  12 . 
         [0026]    In an alternative embodiment, depicted in  FIG. 5  the support bar  112  has alternative engagement elements  146 . The cradle  114  and retaining strap  128  are substantially similar to the embodiment described above, with the exception that retaining means  134  comprise bosses for engagement in a receiving structure  136 . The cheek pads  116  in the alternate embodiment include a plurality of hooked extensions  150  each comprised of a displaceable material such as plastic that is biased to return to and remain in a retaining position such as that depicted in  FIG. 7 . The retaining elements  150  are dimensioned to engage the retaining elements  146  on the rod  112 . 
         [0027]    The cheek pad  116  of this embodiment has three positions. In the engaged or closed position, those retaining elements  150  having the shorter vertical dimension  150 A will retain a longitudinal locking element  152  in position to hold the stabilizer bar  112  on the cheek pad. Another position is completely removed from engagement, which position is provided for emergency removal of the bar  112  and cradle  114  apparatus. In such a circumstance, the longitudinal members  156  of the locking element  152  may be displaced inwardly for disengagement with the hooking elements of the retaining extensions  150 , thereby making the entire locking element  152  removable from the cheek pad and thereafter, the rod  112  also removable therefrom. In an intermediate position, taller retaining elements  150 B are used to temporarily engage the longitudinal elements  156  of the retaining strap  152 . In this position, the stabilizer bar  112  may be translated through the channel  184  defined by the series of extension elements  150  in the cheek pad  116 . This position is used for longitudinal adjustment the bar  112  and cheek pad  116  relative to one another, in order for the user to find an optimal position for the endotracheal stabilizer overall. Once the ideal position of the stabilizer bar  112  relative to the cheek pad  116  has been selected, the longitudinal elements  156  of the locking element  152  are pressed into the lower-most, retaining position to fix the user-selected position for ongoing placement and stabilization of an endotracheal tube. One end of locking element  152  extends beyond the check pad  116  as a tab to facilitate positioning or removal by being easier to grasp. 
         [0028]    In the cheek pad assembly a post  178  is provided. In the depicted embodiment the post is somewhat conical and smooth. The outside dimension of post  178  matches the inner dimensions of post receiver  154  in retaining strap  152 . The outer dimensions of post receiver  154  are used for mounting and seating a neck strap hole for adjustment of the neck strap. Any one of the adjustment holes in the neck strap may be placed over elements  54  or  154  for appropriate adjustment. 
         [0029]    The smooth interface in the depicted embodiment between the outer surface of post  178  and the inner surface of post receiver  154  facilitates ease of vertical adjustment of the retaining strap  152  among its three different positions. 
         [0030]      FIG. 6  further depicts retaining posts  180  that project upwardly into a channel defined for receiving the stabilizing bar  112 . After assembly, the innermost of these posts  180 —that is the post  180  most distal from the patient&#39;s mouth—will engage tabs  182  in an end area of the stabilizer bar  112 . By abutting the retaining posts  180 , the tabs  182  arrest separation or axial movement of the stabilizer bar  112  outwards from the channel  184  defined for it in the cheek pad receiver assembly. 
         [0031]    To facilitate sanitary packaging and ease of application of the device on the patient, the nurse receives the stabilizer bar and cheek pad in a pre-assembled position within a sealed package which may optionally be sterile. The cheek pad/stabilizer bar assembly is packaged in the intermediate position, ready for adjustment to the individual patient as described above, but not needing to be assembled together. The tube holder device is also removed from its sealed packaging with a cover over the adhesive surface on the inside of the cheek pads. The adjustment procedure allows for adjustments to be made and the stabilizer bar, retaining strap and cheek pad receiver assembly to be placed in their lockdown position before removal of the adhesive cover and application of the adhesive inner surface of the cheek pad to the patient. 
         [0032]    Upon pressure downwardly on the retaining strap  152  in order to place the longitudinal elements  156  in the lockdown position, the outwardly facing bosses  146  of the stabilizer bar  112  will engage the rungs or transverse members  192  of the retaining strap  152 . Hence, the stabilizer bar  112  is restrained from being withdrawn improperly from the cheek pad by the abutment of a proximal side  194  of each boss  146  with a distal side  196  of the transverse members  192  of the retaining strap  152 . As a further assurance against improper withdrawal, the tabs  182  would be arrested from improper withdrawal by pegs  180  in any event. Before the longitudinal elements  156  of the retaining strap  152  are placed in their lockdown position, the tabs  182  do not interfere with longitudinal travel of the stabilizer bar  112  in the receiving channel  184 . 
         [0033]    The overall cheek pad assembly flexes and is bendable to facilitate a comfortable adjustment and placement on the patient in a manner that enables the device to be contoured to the patient&#39;s facial features. An appropriate amount of rigidity is maintained by a stiffer skeleton element  198  within the cheek pad. 
         [0034]    The cradle or sled for receiving the endotrachael tube in the depicted embodiments would have a friction surface for arresting undesirable travel of the endotrachael tube in or out of the patient&#39;s mouth. This may be by means of the ribs  26  depicted in the first embodiment or, in the alternative, may include, without limitation a soft elastomeric material having a higher coefficient of friction to serve the same purpose. 
         [0035]    The present invention also includes an advantageous method of manufacture. The depicted embodiments are comprised of a malleable metal stabilizing rod core over which the various operational elements and features of the invention are molded in polymers. A harder polymer such as, for example without limitation, polyurethane, may be used where greater rigidity may be advantageous, for example the outer sections of the stabilizing rod  112  such as at area  200  having the teeth  46 / 146  and in the stabilizer bar receiver assembly  202  on the cheek pads  116 . The same is true for inner components  204  of the tube cradle. The same may be true for tube strap receiver  136 . Other portions of the device of the present invention may be more advantageously made of a soft material such as a more flexible elastomeric, including for example portion  210  of the stabilizer bar and strap  128 . 
         [0036]    According to the method of manufacturing the present invention, the rigid but malleable rod  212  would be placed in a first mold or a first concave of a single mold having a first insert that would block or fill the space to be later filled by the softer elastomeric material. The tool would then define as its inner concavity the shape of the harder plastic elements  200  (or  202 ). These would be injected and molded. After cooling and extraction of the stabilizer rod core  212  with the hard plastic components now attached, the work piece is placed in a second mold, or a second portion of the same mold, having a different internal concavity. The work piece assembly  212 / 200  is put in position in order to receive the injection of the softer elastomeric material, in order to fabricate portions  210  and the other soft polymer portions of the device. Advantageously, the structure of the bosses  146 , tabs  182  of hard plastic in the portions  200  of the stabilizing rod  112  may be used to hold, stabilize and/or center the work piece in the mold for injection of the softer elastomeric material. Hence by over molding the rod  212  is properly positioned in the softer elastomeric material. 
         [0037]    As various modifications could be made to the exemplary embodiments, as described above with reference to the corresponding illustrations, without departing from the scope of the invention, it is intended that all matter contained in the foregoing description and shown in the accompanying drawings shall be interpreted as illustrative rather than limiting. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims appended hereto and their equivalents.