Abstract:
An airway tube securing device (ATSD) having a tubular constrictor attached to an oral piece and a fastener for fastening the ATSD to the face of a patient provides for the correct placing and fixation of an airway tube within the patient&#39;s airways. A rotatable clamp provides for constricting the airway tube thereby securing it to the oral piece. An optional mouthpiece attached to the proximal face of the oral piece provides for the protection of the tube from the jaws of a patient. One or two apertures in the oral piece provide for further insertion of tubing, auxiliary intubation tools and or probes.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part of U.S. patent application Ser. No. 12/067,459, filed Mar. 20, 2008, now U.S. Pat. No. 8,156,934, which is a national stage application of PCT/IL2006/001116, filed Sep. 21, 2006, which claims priority to U.S. Provisional Patent Application Ser. No. 60/596,404, filed Sep. 21, 2005, the disclosures of which are hereby expressly incorporated by reference herein in their entirety. 
     
    
     FIELD OF THE DISCLOSURE 
       [0002]    The present disclosure relates to auxiliary tools for securing airway tubing to a patient. 
       BACKGROUND OF THE DISCLOSURE 
       [0003]    Oral intubation is commonly applied in the course of medical treatments such as operations involving anesthesia, in which breathing is assisted and controlled by airway tubing. Endotracheal and/or laryngeal tubes are typically used in such operations for delivering oxygen and medicines to the trachea. The correct placement and fixation of such tubes is critical in maintaining the patient&#39;s wellbeing. However, displacement of such tubes remains a risk. Even initially as an endotracheal and/or laryngeal tube is properly positioned and secured by currently available means, the tube will often displace due to mechanical activity, associated with the instrumentation and patient movements. Such displacement can harm the patient in several ways. Effort invested in the development of superior intubation means, yielded auxiliary intubation tools, aids and procedures. Securing the insertion of endotracheal and/or laryngeal tubes still require attention of the medical team which interfere with other essential procedures. A device disclosed in U.S. Pat. No. 5,626,128 addresses this problem by maintaining an endotracheal tube in proper position within a patient&#39;s mouth by means of an oral adhesive composition. However, the employment of such a device obviates the use of some additional devices targeted at the oral cavity, such as suction tubes. 
       SUMMARY 
       [0004]    The present disclosure provides an airway tube securing device (ATSD) having a tubular constrictor attached to an oral piece and a fastener for fastening the ATSD to the face of a patient to provide for the correct placing and fixation of an airway tube within the patient&#39;s airways. 
         [0005]    According to an embodiment of the present disclosure, a device is provided for securing an airway tube in a patient. The device includes an oral piece configured to couple to the patient, a constrictor extending longitudinally from the oral piece, the constrictor comprising a plurality of segments that are radially-spaced apart, the plurality of segments cooperating to define an aperture for receiving the airway tube, each segment increasing in thickness from a first side to a second side, and a clamp rotatably coupled to the constrictor to adjust the constrictor between a first configuration and a second configuration, the clamp comprising a plurality of projections that are radially-spaced apart and that protrude inwardly toward the constrictor, the projections of the clamp positioned near the first sides of the segments in the first configuration and positioned near the second sides of the segments in the second configuration, the segments extending further inwardly toward the airway tube in the second configuration than the first configuration. 
         [0006]    According to another embodiment of the present disclosure, a device is provided for securing an airway tube in a patient. The device includes an oral piece configured to couple to the patient, a constrictor extending longitudinally from the oral piece, the constrictor comprising a plurality of segments that are radially-spaced apart, the plurality of segments cooperating to define an aperture for receiving the airway tube, and a clamp comprising a plurality of projections that are radially-spaced apart and that protrude inwardly toward the constrictor, the clamp rotating relative to the constrictor to adjust the constrictor between a first configuration and a second configuration, the constrictor applying a clamping force to the airway tube that increases continuously from the first configuration to the second configuration. 
         [0007]    According to yet another embodiment of the present disclosure, a method is provided for securing an airway tube in a patient. The method includes the steps of providing a device that includes an oral piece, a constrictor coupled to the oral piece, the constrictor having a plurality of radially-spaced apart segments that cooperate to define an aperture, and a clamp, the clamp having a plurality of radially-spaced apart projections, securing the oral piece to the patient, inserting the airway tube into the aperture of the constrictor, and rotating the clamp around the constrictor to continuously tighten the segments of the constrictor against the airway tube. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]    The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein: 
           [0009]      FIG. 1  is a side view of a preferred embodiment of the airway tube securing device (ATSD) according to the present disclosure; 
           [0010]      FIG. 2  is a side view of the ATSD shown in  FIG. 1 , with an elastic facial fastening strip; 
           [0011]      FIG. 3  is a top side view of the ATSD shown in  FIG. 1 ; 
           [0012]      FIG. 4  is an isometric view of a preferred embodiment of the constrictor according to the present disclosure; 
           [0013]      FIG. 5A  is an isometric view of an ATSD according to the present disclosure, attached to a Murphy cuffed endotracheal tube; 
           [0014]      FIG. 5B  is an isometric view of an ATSD according to the present disclosure, attached to a laryngeal mask; 
           [0015]      FIG. 6  is an isometric view of an ATSD according to another preferred embodiment of the present disclosure; 
           [0016]      FIG. 7  is a sectional view of a constrictor according to another preferred embodiment of the present disclosure; 
           [0017]      FIG. 8  is an isometric view of an ATSD according to another preferred embodiment of the present disclosure; 
           [0018]      FIG. 9  is an isometric view of an ATSD according to yet another preferred embodiment of the present disclosure, the ATSD shown with a fastening strip; 
           [0019]      FIG. 9A  is a detailed isometric view of the portion of the ATSD circled in  FIG. 9 ; 
           [0020]      FIG. 10  is an isometric view of the ATSD of  FIG. 9  shown without a rotatable clamping means; 
           [0021]      FIG. 10A  is a detailed isometric view of the portion of the ATSD circled in  FIG. 10 ; 
           [0022]      FIGS. 11A and 11B  are isometric views of the rotatable clamping means of  FIG. 9 ; 
           [0023]      FIG. 12A  is a cross-sectional view of the ATSD of  FIG. 9A , taken along line  12 - 12  of  FIG. 9A , and showing the ATSD in an open state; 
           [0024]      FIG. 12B  is a cross-sectional view similar to  FIG. 12A , showing the ATSD in a constricted state; 
           [0025]      FIG. 13A  is a top plan view of the ATSD in the open state of  FIG. 12A ; and 
           [0026]      FIG. 13B  is a top plan view of the ATSD in the constricted state of  FIG. 13A . 
       
    
    
       [0027]    Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the invention and such exemplifications are not to be construed as limiting the scope of the invention in any manner. 
       DETAILED DESCRIPTION 
       [0028]    Reference is first made to  FIG. 1 , which schematically shows a side view of an airway tube securing device (ATSD), according to a preferred embodiment of the present disclosure. A section of airway tube  10  is shown traversing a pass-through aperture in segmented constrictor  20  of oral piece  22 . By rotating clamping means  24  the inner diameter of the segmented constrictor  20  diminishes, thereby clamping airway tube  10  and securing it firmly to oral piece  22 . Mouthpiece  26 , which is substantially coaxial with airway tube  10 , protrudes from the proximal face of oral piece  22 . The mouthpiece  26  is inserted in a patient&#39;s oral cavity between upper and lower jaws. Face fastening strip  28  with Velcro® strips  29  attached to both ends, respectively, fastens the oral piece  22  to the patient&#39;s face by strapping fastening strip  28  against the patient&#39;s neck onto either its proximal or distal faces. Other variants of the fastening mechanism include different connecting means, used to connect strips  29  to oral piece  22 , including among other possibilities buckles, clamping connectors, hooks attached to the strips&#39; ends, or Velcro® strips attached to the proximal face of the fastening strip. 
         [0029]    Reference is now made to  FIG. 2 , showing an oral piece  22  of the disclosure, implementing an elastic facial fastening strip  28 , using hook  30  inserted into ring  31  connected to the oral piece  22  end by means of strip connector aperture  34 . Strip hooks  30  may also be directly inserted into strip connector apertures  34 . Hook  30  attached at the end of the fastening strip  28  is shown passing through strip connector apertures  34 . 
         [0030]    Reference is made to  FIG. 3  showing a topside view of an ATSD of the disclosure. Segmented constrictor  20  is located at the center of oral piece  22 . Two additional apertures  32 , adjacent segmented constrictor  20  and distributed symmetrically at its sides, facilitate the application of additional devices such as thermometers, probes and/or suction tubes. The ends of fastening strip  28  are shown passing through strip connector apertures  34  symmetrically located on both sides of the oral piece  22 . 
         [0031]    Reference is made to  FIG. 4  showing an isometric view of segmented constrictor  20 , in which airway tube  10  is inserted. Set of constricting segments  40 , having a cylindrical thread  45  on their external surfaces and a conic interior (not shown) is split by longitudinal section  42  into two segments. One end of each of the constricting segments  40  is firmly secured to the oral piece  22 . The internal surface of constricting segments  40  is roughened for higher friction and improved clamping of the airway tube  10 . The radius of the lumen of segmented constrictor  20  decreases as the distance from the distal face of the oral piece  22  increases. Insertion of an airway tube  10  into segmented constrictor  20  divides the longitudinal constricting segments  40  along longitudinal section  42 . Segmented constrictor  20  according to the disclosure also consists of a clamping means  24  that is a hollow body such as a nut, rotatable over the constricting segments  40  such that the pressing force exerted over the constricting segments  40  increases or decreases according to its direction of rotation. Rotating clamping means  24  clockwise changes the inner diameter of the segmented constrictor  20  due to its interior conical shape. Decreasing the inner diameter of segmented constrictor  20  applies pressure to the exterior surface of airway tube  10  pressing it against the constricting segments  40 . Flexible ring  44  attached to one or both ends of the segmented constrictor wall  40  prevents clamping means  24  from falling off. 
         [0032]    By means of properly selecting internal conical shape and angle formed by the inner surface of the constricting segments  40  and external thread spacing  45 , the same segmented constrictor  20  can be adapted to a range of tube diameters starting with one of 2.5 millimetres (mm) suitable for neonates and up to 10-11 mm for male adults. Rotating the constrictor nut  24  by a specific rotational angle changes the inner diameter of the segmented constrictor  20  proportionally. One segmented constrictor  20  may be adapted to cover the entire range of available airway tubes  10 . 
         [0033]    Securing the airway tube  10  to the oral piece  22  is typically achieved at a point in which tightening the segmented constrictor nut  24  requires a significantly higher rotational torque. An experienced operator is capable of securing the airway tube  10  fixed to the oral piece  22  by sense of touch. It is possible to ensure that the suitable rotational angle of the nut  24  for loosening or tight clamping of a specified airway tube  10  is easily recognized by the medical team. One way, for example, is to configure the segmented constrictor  20  such that rotating the constrictor nut  24  by 90 degrees is equivalent to a 0.5 mm change in the diameter of the airway tube  10 . Alternatively, it is possible to apply color to the thread coils  45  accordingly, employing different hues for designating the progression of the constricting nut  24  on the thread  45 . Namely, threads coils  45  corresponding to tube diameter below 3 mm are colored with black, the range 3-4 mm with deep red, 4-5 light red, 5-6 orange, 6-7 yellow, 7-8 green 8-9 blue, 9-10 violet and above 10 white. Other variants consist of a few dedicated oral pieces  22  having segmented constrictors  20  corresponding to different ranges of airway tube diameters and further employing color coding corresponding to these different ranges, in a similar scheme as described above. 
         [0034]    In another embodiment of the present disclosure, a knob is employed, such that distinctly audible clicking sounds indicate a proper alignment with the inserted tube  10 . The knob is installed at the segmented constrictor  20  side extending sideways at the distal side of the oral piece  22 . The knob is coupled to the constrictor nut  24  by means of an axle. Click indications correspond to the following tube diameter values: 2.5, 3, 3.5, and 4 mm. 
         [0035]    The ATSD in accordance with the present disclosure is typically made of plastic material that can sustain high temperatures. Such an ATSD can be sterilized and reused, thus providing an inexpensive and valuable intubation aid to be used in the operation theatre. The ATSD is accommodated for attaching various laryngeal as well as endotracheal airway tubes in place. Reference is made to  FIGS. 5A-B . In  FIG. 5A  an ATSD applied to a Murphy cuffed endotracheal tube  10 ′ is shown. In  FIG. 5B  an ATSD as applied to a laryngeal mask  10 ″ is shown. A suitable ATSD may be packaged separately or together with a respective endotracheal airway tube  10 ′, or with a laryngeal mask  10 ″, as an airway intubation kit, ready for use by the medical staff 
         [0036]    Reference is now made to  FIG. 6 , which shows an ATSD  50  according to another preferred embodiment of the disclosure. ATSD  50  of  FIG. 6  includes a segmented constrictor  51  having a longitudinally segmented tube, the wall of which is divided into set of constricting segments  52  separated by recesses  58 . ATSD  50  also includes a rotatable clamping means  56  around the segmented constrictor  51 . 
         [0037]    Each constricting segment  52  has an inner surface  52   a  that faces the airway tube (not shown), an outer surface  52   b  that faces clamping means  56 , a first side  52   c,  and an opposite second side  52   d.  Each constricting segment  52  has a tapering flank. In the illustrated embodiment of  FIG. 6 , for example, outer surface  52   b  of each constricting segment  52  ramps inwardly from second side  52   d  to first side  52   c,  such that each constricting segment  52  tapers inwardly from second side  52   d  to first side  52   c.  This tapering effect is evident if  FIG. 6 , because each constricting segment  52  is generally wedge-shaped in cross-section, having more thickness at second side  52   d  than at first side  52   c,    
         [0038]    The segmented constrictor  51  of ATSD  50  is shown in an open or unconstricted state in  FIG. 6 , where the inwardly protruding projections  54  located on the inner surface of annular clamping means  56  are projected into corresponding recesses  58  spacing constricting segments  52  apart. The airway tube (not shown) is securely locked inside oral piece  60  by rotating clamping means  56  in the direction indicated by arrow  59 . More specifically, the airway tube is locked by rotating projections  54  of clamping means  56  across the ramped outer surfaces  52   b  of constricting segments  52  from first sides  52   c  toward second sides  52   d.  By such rotation, projections  54  force inner surfaces  52   a  of constricting segments  52  against the exterior surface of the airway tube. Because constricting segments  52  grow in thickness from first sides  52   c  to second sides  52   d,  the clamping force that is transferred from clamping means  56  to constricting segments  52  and from constricting segments  52  to the airway tube may increase continuously as projections  54  of clamping means  56  travel from first sides  52   c  toward second sides  52   d  of constricting segments  52 . 
         [0039]    Clamping means  56  is securely locked in a constricting position, when projections  54  reach corresponding recesses  61  in outer surfaces  52   b  of constricting segments  52 . In  FIG. 6 , recesses  61  are located near second sides  52   d  of constricting segments  52 . Thus, the clamping force that is transferred from clamping means  56  to constricting segments  52  and from constricting segments  52  to the airway tube may increase continuously until projections  54  enter recesses  61  near second sides  52   d  of constricting segments  52 . The airway tube is unlocked by rotating clamping means  56  in the opposite direction of arrow  59  to release projections  52  from recesses  61 . Depending on the size of the airway tube therein, segmented constrictor  51  may achieve a desired clamping force against the airway tube without rotating clamping means  56  all the way to recesses  61 . Thus, clamping means  56  may reach its final position somewhere between first sides  52   c  and second sides  52   d  of constricting segments  52 . 
         [0040]    Oral piece  60  has one or two additional apertures  64  for the optional insertion of additional devices and/or tubes as described hereinbefore. Strip connector apertures  66  provide for connecting a fastening strip to oral piece  60 . Oral piece  60  has the option for a mouthpiece attachment to its proximal face, providing for protection of the airway tubes from the patient&#39;s jaws. 
         [0041]    Reference is now made to  FIG. 7 , which shows a sectional view of a segmented constrictor  73  according to another embodiment of the present disclosure. The segmented constrictor  73  is shown in a constricting position in  FIG. 7 . Constricting segments  70  of segmented constrictor  73  compress airway tube  72  as pawls  74  of annular clamping means  75  press constricting segments  70  against the wall of airway tube  72 . By such pressing the lumen of segmented constrictor  73  becomes partially conic as its diameter decreases along the flanks of the constricting segments  70  as the distance from the distal face of the oral piece (not shown) increases. Segmented constrictor  73  attains a secure constricting position as pawls  74  are shifted from the longitudinal slits  77  between adjacent constricting segments  70  and into external recesses  78  in the constricting segments  70  by rotating clamping means  75  having internal recesses for securing the pawls in the direction indicated by arrow  79 . 
         [0042]    Reference is now made to  FIG. 8 , in which an ATSD according to another preferred embodiment is shown. This ATSD consists of the same segmented constrictor  80  as the ATSD shown in  FIG. 6 . However, the oral piece  86  of this ATSD has only one side having an optional aperture  88 . This aperture  88  provides for the insertion of additional devices  89  (shown in phantom), where each device  89  may be in the form of a thermometer, an ultrasound probe, or a suction tube, for example. Fastening strip  90  is connected to corresponding aperture  92  located at the end of oral piece  86 . Optionally, oral piece  86  includes a buckle  93  (shown in phantom) for connecting the ATSD to fastening strip  90 . Noose  94  attached to the other end of fastening strip  90  is hooked to segmented constrictor  80  such that a space  96  is made available for the insertion of additional devices and/or probes (such as an ultrasound probe) into a patient&#39;s oral cavity. 
         [0043]    Reference is now made to  FIGS. 9-13B , which show ATSD  100  according to another preferred embodiment of the disclosure. ATSD  100  is similar to the above-described ATSD&#39;s, especially ATSD  50  of  FIG. 6 , with like reference numerals indicating like elements. 
         [0044]    ATSD  100  includes oral piece  160 . Oral piece  160  includes additional side apertures  164  for the optional insertion of additional devices and/or tubes, as described hereinbefore. Oral piece  160  also includes strip connector apertures  166  for connecting a fastening strip  128  to oral piece  160 , as shown in  FIG. 9 . Oral piece  160  further includes mouthpiece  126 , as shown in  FIG. 9 , that is inserted in a patient&#39;s oral cavity between upper and lower jaws to protect the airway tube. 
         [0045]    ATSD  100  also includes segmented constrictor  151 , which includes longitudinal constricting segments  152  separated by recesses  158 . ATSD also includes a rotatable clamping means  156 , which is shown separately in  FIGS. 11A and 11B . The illustrative clamping means  156  includes a plurality of radially-spaced internal protrusions  154  to operate segmented constrictor  151 , as well as a plurality of radially-spaced external protrusions  157  to facilitate gripping and turning by a user. 
         [0046]    As shown in  FIGS. 10 and 10A , each constricting segment  152  has an inner surface  152   a  that faces the airway tube (not shown), an outer surface  152   b  that faces clamping means  156 , a first side  152   c,  and a second side  152   d.  Each constricting segment  152  has a tapering flank. In the illustrated embodiment of  FIG. 10 , for example, outer surface  152   b  of each constricting segment  152  ramps inwardly from second side  152   d  to first side  152   c,  such that each constricting segment  152  tapers inwardly from second side  152   d  to first side  152   c.  This tapering effect is evident if  FIG. 10 , because each constricting segment  152  is generally wedge-shaped in cross-section, having more thickness at second side  152   d  than at first side  152   c.    
         [0047]    Inner surface  152   a  of each constricting segment  152  may also contribute to this tapering effect. In the illustrated embodiment of  FIG. 10A , longitudinal ribs  192  extend from inner surface  152   a  of each constricting segment  152  near second side  152   d.  Thus, like outer surface  152   b,  inner surface  152   a  of each constricting segment  152  increases in thickness from first side  152   c  to second side  152   d.  Each longitudinal rib  192  may also increase in thickness away from oral piece  160  and mouthpiece  126 . 
         [0048]    In  FIGS. 12A and 13A , segmented constrictor  151  of ATSD  150  is shown in an open or unconstricted state. In this open state, the inwardly protruding projections  154  of clamping means  156  are positioned near first sides  152   c  of constricting segments  152 . Projections  154  of clamping means  156  may be positioned as close as possible to recesses  158  between adjacent constricting segments  152 . 
         [0049]    Stops  190  on the adjacent constricting segments  152  may prevent projections  154  of clamping means  156  from fully entering and projecting into recesses  158  near first sides  152   c  when in the open state. Thus, even though  FIG. 12A  is described as an open or unconstricted state, projections  154  of clamping means  156  may apply some clamping pressure to constricting segments  152  near first sides  152   c  in the open or unconstricted state. 
         [0050]    In  FIGS. 12B and 13B , segmented constrictor  151  of ATSD  150  is shown in a clamped or constricted state. From the open state of  FIGS. 12A and 13A  to the constricted state of  FIGS. 12B and 13B , clamping means  156  has been rotated by about 120 degrees in the direction of arrow A. By such rotation, projections  154  of clamping means  156  travel across the ramped outer surfaces  152   b  of constricting segments  152  from first sides  152   c  toward second sides  152   d.  Because constricting segments  152  grow in thickness from first sides  152   c  to second sides  152   d,  this rotation of clamping means  156  forces inner surfaces  152   a  of constricting segments  152  progressively inward toward the airway tube. Thus, the clamping force that is transferred from clamping means  156  to constricting segments  152  and from constricting segments  152  to the airway tube may increase continuously from the open state to the constricted state. Longitudinal ribs  192  on inner surfaces  152   a  of constricting segments  152  may also contribute to this increasing clamping force as clamping means  156  approaches second sides  152   d  of constricting segments  152 . 
         [0051]    Stops  190  on the adjacent constricting segments  152  may prevent projections  154  of clamping means  156  from fully entering and projecting into recesses  158  near second sides  152   d  when in the clamped state, like in the above-described open state. Depending on the size of the airway tube therein, segmented constrictor  151  may achieve a desired clamping force against the airway tube without rotating clamping means  156  all the way to stops  190 . Thus, clamping means  156  may reach its final position somewhere between adjacent stops  190 . 
         [0052]    While this invention has been described as having exemplary designs, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.