Abstract:
An endotracheal tube system having an improved connector to provide a more secure connection to an endotracheal tube. In specific example embodiments, the connector is tapered, is spiraled, or provides threading to improve connection and prevent inadvertent detachment. In certain embodiments, the connector is colorized to correspond to an endotracheal tube size, and in an embodiment, specific packaging permits color to be visualized to aid in proper tube size selection.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit under 35 U.S.C. §119(e) to U.S. Provisional Application U.S. 61/073,165 entitled “Endotracheal tube with color-coded secure connector and packaging” filed Jun. 17, 2008, which is herein incorporated by reference as if more fully set forth. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to medical devices generally. More specifically, the invention relates to an improved endotracheal tube connector, as well as a packaging, and sizing system. 
       BACKGROUND 
       [0003]    Endotracheal intubation is a necessary skill for a variety of medical professionals. Anesthesiologists, Emergency Physicians, Paramedics, and other professional personnel secure a patient&#39;s airway by placement of an endotracheal tube (also known as an ET tube) within the trachea of a patient. Placement may occur in a controlled way, such as an operating room environment, or may be undertaken more emergently at bedside, in the Emergency Department, or by trained ambulance personnel in a field or battlefield setting. Proper placement of an endotracheal tube is of paramount importance; potentially catastrophic implications may be expected where a patient is not ventilated or is inadequately ventilated. 
         [0004]    Endotracheal tube placement may be difficult and challenging, even for seasoned professionals, and may be complicated by the patient&#39;s physiological status, as well as other factors, including traumatic deformation of the oropharynx, blood, dentition, vomitus, or other foreign material in the patient&#39;s oral cavity. Additionally, infants and pediatric patients may present special challenges in securing adequate tube placement. 
         [0005]    Following successful tube placement, professionals are cautious to avoid disconnecting the connector from proximal portion of the endotracheal tube; unrecognized disconnections may be life threatening. The probability that a connector will become unintentionally disconnected is increased where ventilation occurs in a setting outside the operating room, such as a complicated field setting (e.g. the extrication of a trapped patient), or where the patient must be moved. Accordingly, it is important to maintain proper tube placement—particular in circumstances where initial placement was difficult. 
         [0006]    Selecting the proper size ET tube size is also critically important. Where the chosen tube is too small, the relatively smaller cross-sectional luminal diameter will be smaller compared to the required tidal volume—making ventilation more difficult. Further, an improperly small tube may be more subject to dislodgement, may inadequately seal the airway, and may make any necessary subsequent required instrumentation occurring through the tube (e.g. bronchoscopy) more difficult. In contrast, an improperly large tube may be unnecessarily difficult to pass and cause trauma to the airway. Improper tube selection is more common under rushed or emergent circumstances, where the professional performing the skill has relatively limited recent experience, and in settings where intubation is infrequently performed. 
         [0007]    The need to verify proper tube placement and size is common, particularly where a patient is transferred from one professional or service to another. As a placed tube is often secured by tape, confirmation of the tube size may be difficult where tube sizing indicia itself is obscured by the tape. Lastly, patient management may become problematic where the free end of the pilot balloon line becomes entangled in other equipment or where the pilot balloon cannot be quickly located where intubation is performed in unfavorable field settings. 
         [0008]    There have been devices utilizing color coding to assist with identification of tube size. For example, U.S. Pat. No. 4,483,337 to Clair, discloses, in part, a color-coding system for identifying endotracheal tube size, including a color-coded strip along the longitudinal length of the tube from the connector to approximately the area of the exit of the pilot line. U.S. Pat. No. 6,050,263 to Choksi, et al. discloses, in part, an endotracheal tube holder having, inter alia, a support bar and platform and tube that may have coloration to indicate size. U.S. Pat. No. 4,926,885 to Hinkle discloses, in part, a method of identifying and selecting medical equipment, medication doses and/or medical supplies, and to the equipment used to carry out the method; the method is largely based upon anatomical dimensions. However, the prior art solutions are not without problems. For example, use of a color coded strip may interfere with patient care efforts and become soiled in any traumatic resuscitative events. Apparatus designed to serve as an endotracheal tube holder may be cumbersome in certain clinical circumstances and require specific clinician familiarity before use. Further, methodologies derived largely from anatomical dimensions may be more time consuming to apply, particularly in emergency situations. 
       SUMMARY 
       [0009]    The present invention discloses a color-coding system which matches the color of an endotracheal tube and connector to a specific cross-sectional luminal diameter. Further embodiments provide for corresponding packaging permitting at least a portion of a colored connector, tube, or both to be visible through the packaging thereby aiding in rapid selection of an appropriate tube size. The invention further discloses a series of non-uniform improved endotracheal tube connectors to provide a more secure attachment between an endotracheal tube and connector and may permit the connector to be secured to a tube more tightly than a conventional connector. Further, the connector may be tightened more easily as the user applies a twisting action to insert the connector into the tube. Further, in specific embodiments, the connector has threading which may provide a more secure connection by disrupting a fluid layer that may accumulate between the connector and tube&#39;s interior. Further, as at least a portion the tube must stretch or deform to accommodate certain embodiment connectors, the tube must likewise change shape before it can slip—making inadvertent disconnection less likely. The inventive connector will allow purposeful separation when needed. In a further embodiment, the connector bears one or more notches where the pilot balloon of an endotracheal tube may be secured. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1  is a perspective view of an embodiment endotracheal tube. 
           [0011]      FIG. 2  is a perspective view of an embodiment endotracheal tube illustrating the pilot balloon line secured to the connector. 
           [0012]      FIG. 3  is a perspective view of an embodiment endotracheal tube connector. 
           [0013]      FIG. 4  is a perspective view of an embodiment endotracheal tube connector. 
           [0014]      FIG. 5  is a chart showing an illustrative example embodiment color-coding system. 
           [0015]      FIG. 6  is a perspective view of example embodiment packaging. 
           [0016]      FIG. 7  is a perspective view of example embodiment packaging. 
           [0017]      FIG. 8  is a perspective view of an embodiment barb connector. 
           [0018]      FIG. 9  is a perspective view of an embodiment leading spiral connector. 
           [0019]      FIG. 10  is a perspective view of an embodiment trailing spiral connector. 
           [0020]      FIG. 11  is a perspective view of an embodiment negative spiral connector. 
           [0021]      FIG. 12  is an elevation view of an embodiment positive spiral connector. 
           [0022]      FIG. 13  is an elevation view of an embodiment tapered diamond thread spiral connector. 
           [0023]      FIG. 14  is an elevation view of an embodiment tapered shaft, diminishing bullnose thread connector. 
           [0024]      FIG. 15  is an elevation view of an embodiment tapered shaft, non-diminishing bullnose thread connector. 
           [0025]      FIG. 16  is an elevation view of an embodiment non-tapered shaft, non-diminishing flattened diamond thread connector. 
           [0026]      FIG. 17  is an elevation view of an embodiment non-tapered shaft, diminishing flattened diamond thread connector. 
       
    
    
     DETAILED DESCRIPTION 
       [0027]    In one embodiment of the present invention,  FIG. 1  illustrates an endotracheal tube generally  10  comprising a tube body  12  commonly comprised of PVC tubing having a proximal end  14  and a distal end  16 . There is an air instillation port  17  communicating with a pilot balloon and pilot balloon line  18  which leads to cuff  19  located relatively distally on tube body  12 . In one embodiment, illustrated by  FIGS. 3 and 4 , connector  20  is comprised of a first end  22  that is uniform in diameter, which slides within and reversibly affixes to a ventilation device such as a mechanical ventilator, the Y-piece of an anesthetic delivery system, or a conventional bag-valve combination, such as an Ambu® bag. The second end  26  connects to an endotracheal tube. Second end  26  of connector  20  is coupled to the proximal end  14  of tube body  12 . A planar surface  28  between first end  22  and second end  26  aids in providing a space to hold and manipulate the connector  20  as well as tube  12  when connector  20  is coupled thereto. In one embodiment, connector  20  bears notches  24  on one or both lateral sides of planar surface  28 ; the notches are capable of reversibly receiving and holding pilot balloon line  18  as illustrated by  FIG. 2 . 
         [0028]    One aspect of the present invention is to provide an endotracheal tube connector that more securely attaches to the proximal end  14  of tube  12 . Generally, endotracheal tube connectors are straight and smooth and may slightly narrowingly taper. One aspect of the present invention is to provide a series of improved connectors that permit greater resistance to dislodging from tube  12  and, in some embodiments, may prevent leakage and may decrease contamination passing around second end  26  into tube  12  or from within tube  12  around second end  26  to contaminate the outside of tube  12 . 
         [0029]    For illustrative purposes, when referring to connector  20 , it will be helpful to consider the first end  22  as the proximal end and second end  26  as the distal end. In one embodiment illustrated by  FIG. 8 , a barbed connector  20   a  has a first end  22   a,  a second end  26   a  and planar surface  28   a.  In this embodiment, second end  26   a  has a flared portion  45   a,  which flares outwardly as second end  26   a  contacts planar surface  28   a.  Second end  26   a  has straight portion  50   a,  and terminates in barb  55   a  at the distal portion of the second end  26   a.    
         [0030]      FIG. 9 , illustrates an alternative leading spiral embodiment, wherein a leading spiral connector  20   b  has first end  22   b,  and second end  26   b,  and planar surface  28   b  therebetween. Second end  26   b  has a flared portion  60   b,  which outwardly flares as second end  26   b  contacts planar surface  28   b.  The surface of second end  26   b  has a relatively broad, constant diameter spiral  65   b  which begins at the distal end of second end  26   b.  Spiral  65   b  terminates at flared portion  60   b.    
         [0031]      FIG. 10  illustrates a trailing spiral alternative embodiment  20   c,  having first end  22   c,  second end  26   c,  and planar surface  28   c  therebetween. Second end  26   c  has flared portion  70   c  which outwardly flares as second end  26   c  contacts surface  28   c.  Second end  26   c  has a tapered barb  55   c,  which narrowingly tapers from proximal to distal. Barb  55   c  is uninterrupted and creates a seal with proximal end  14  of tube  12 . Flared portion  70   c,  creates a redundant seal where connector  20   c  engages the proximal end  14  of tube  12 . Spiral  75   c  begins just proximal to barb  55   c  and occupies the surface of second end  26   c  from barb  75   c  to flared portion  70   c.    
         [0032]      FIG. 11  illustrates a negative spiral alternative embodiment  20   d,  has first end  22   d,  second end  26   d,  and planar surface  28   d  therebetween. The second end  26   d  has grooving which forms a negative spiral  80   d,  which narrowingly tapers to terminate at end  85   d.    
         [0033]      FIG. 12  illustrates a positive spiral alternative embodiment  20   e,  has first end  22   e,  second end  26   e,  and planar surface  28   e  therebetween. The second end  26   e  has a positive spiral  90   e  which forms a ridge along the surface of second end  26   e,  and narrowingly tapers to terminate at end  95   e.    
         [0034]      FIG. 13  illustrates a tapered spiral embodiment  20   f,  has first end  22   f,  second end  26   f,  and planar surface  28   f  therebetween. Second end  26   f  has a triple spiral diamond shaped spiral thread form  100   f  which terminates in smooth sealing surface  105   f.  Second end  26   f  begins to taper at tapering point  110   f  to narrowingly taper over approximately its distalmost quarter. In an alternative embodiment, second end  26  may be non-tapered, begin to taper at a different point, or taper over the entire second end  26 . 
         [0035]      FIG. 14  illustrates a tapered diminishing thread embodiment  20   g,  has first end  22   g,  second end  26   g,  and planar surface  28   g  therebetween. Second end  26   g  has a bullnose thread  115   g  on its surface which progressively diminishes in height relative to the surface of second end  26   g  beginning at about the proximalmost third  120   g  of second end  26   g.  In an alternative embodiment, the thread may diminish continually over the course of second end. 
         [0036]      FIG. 15  illustrates a tapering, non-diminishing bullnose thread embodiment  20   h,  having a first end  22   h,  second end  26   h,  and planar surface  28   h  therebetween. Second surface  26   h  narrowingly tapers over the course of its entire length. Bullnose thread  125   h  occupies the entire surface of second end  26   h.    
         [0037]      FIG. 16  illustrates a non-tapering, non-diminishing thread embodiment  20   i,  having a first end  22   i,  second end  26   i,  and planar surface  28   i  therebetween. Second end  26   i  is uniform in diameter and has a flattened diamond-form thread  135   i  along its entire surface. The cross-section of diamond thread  135   i  forms a pointed apex  140   i.    
         [0038]      FIG. 17  illustrates a non-tapering shaft, with a diminishing diamond thread form embodiment  20   j  is disclosed and has first end  22   j,  second end  26   j,  and planar surface  28   j  therebetween. Second surface  26   j  has a flattened diamond-form thread  145   j  which progressively diminishes in height relative to the surface of second end  26   j  beginning at about the proximalmost third  150   j  of second end  26   j.    
         [0039]    It should be clear from the foregoing disclosure and expressly noted that the above example embodiments are for illustrative purposes only. It is specifically recognized that various disclosed variables may be interchanged and utilized together or independently, including: taper or non-tapering, the degree or rapidity of taper, the location for the beginning or termination of tapering (e.g. entire distance of second end  26 , distal third, etc.), the presence or absence of a flaring portion (and the degree of flare), and the presence or absence of a barb. Also, multiple threading types are illustratively disclosed in non-limiting examples, such as a positive threading ridge and a negative threading groove. Threading size (including height from the surface and width across the surface of second end  26 ) and shape and number of windings comprising the spiral is variable as is the utilization of diminishing or non-diminishing threading. Additionally, any portion of the second end  26  may be smooth and utilized in conjunction with various thread forms. Also, as second end  26  may have a helical or spiral shape, the density, pitch, height, and width of threading on second end  26  is variable. In a specific alternative embodiment, second end  26  has a plurality of helices independent of each other. 
         [0040]    Turning now to coloration, in one example embodiment, the endotracheal tube is color coded to correspond to a particular endotracheal tube size. Several coloration schemes can be adopted and utilized. One particular useful scheme uses solid colors for each integer size, and a color with stripes for each next non-integer half-size. An exemplar scheme, illustrated by  FIG. 5 , depicts a 6.0 tube as yellow, and a 6.5 tube as yellow with black stripes; a 7.0 tube as blue, and 7.5 tube as blue with black stripes; an 8.0 tube as red, and an 8.5 tube as red with black stripes; a 9.0 tube as green, and a 9.5 tube as green with black stripes. The color of connector  20  matches tube coloration; this provides easy observational recognition and/or confirmation of tube size after placement, without requiring professionals to read printed indicia on the side of tube body  12 . Of course, any non-solid color can be used to indentify non-integer half-sizes. Alternatively, non-solid colors may be used to identify integer sizes. Alternatively, the sizes of tube  10  may correspond with a distinct solid or non-solid tube coloration representing a specific cross-sectional luminal size. 
         [0041]    To facilitate easy recognition prior to use, the endotracheal tube  10  is packaged in packaging  32  which, in one embodiment comprises a first side  36  having printable paper surface that provides printed indicia  40 , such as tube size information. In an alternative embodiment, printed indicia  40  may be omitted. The second side  34  has a clear transparent packaging surface allowing direct visualization of the colored tube  10  and connector  20  within packaging  32 . In an alternative embodiment, the second side may have any surface that permits at least a portion of tube  10  or connector  20  to be visualized sufficient to identify the coloration of either or both. As examples, such surfaces may include a translucent surface or fenestrated surface sufficient to permit color identification. 
         [0042]    In one specific embodiment, the coloration of the packaging is correlated to the tube size and matches the coloration of connector  20 , tube  10 , or both. In this embodiment, packaging  32  may be opaque. 
         [0043]    It should be clearly understood that aspects of the present invention may be practiced independently of one another. For example, tube  10  may be colorized and connector  20  may or may not be colorized, and if connector  20  is colorized, the coloration may correspond to the coloration of tube  10  or may be distinct. Further, connector  20  may be colorized and tube  10  may or may not be colorized, and if tube  10  is colorized, the coloration may correspond to the coloration of connector  20  or may be distinct. Moreover, it should be noted that the varied embodiments of connector  20  may be utilized with or without notches  24 . It should be apparent that connector  20  may be utilized with or without regard to connector or tube  10  coloration. 
         [0044]    While exemplar tube sizes are disclosed, it is recognized that a veterinary application may result in utilization of tubes with different cross-sectional luminal diameters. Accordingly, tube size discussed herein is for illustrative purposes only, and aspects of the present invention may be utilized with larger or smaller tubes. 
         [0045]    Although the present invention has been described with reference to the preferred embodiments, it should be understood that various modifications and variations can be easily made by those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing disclosure should be interpreted as illustrative only and is not to be interpreted in a limiting sense. It is further intended that any other embodiments of the present invention that result from any changes in application or method of use or operation, method of manufacture, shape, size, or material which are not specified within the detailed written description or illustrations contained herein yet are considered apparent or obvious to one skilled in the art are within the scope of the present invention.