Abstract:
A medical device tube having opposing support ears for improved coupling of an inner cannula to an outer cannula. The medical device tube comprises an outer cannula having opposing support ears on an outer cannula connector flange attached to a proximal end of the outer cannula. The opposing support ears maintain locking ears of the inner cannula in substantially one position. The opposing support ears substantially prevent the locking ears in contact with the outer cannula connector flange from slipping therefrom by, e.g., rotation, axial displacement, torsional shear, etc.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of and claims priority to U.S. patent application Ser. No. 12/631,015, filed on Dec. 4, 2009, which claims priority to U.S. patent application Ser. No. 11/237,168, filed on Sep. 28, 2005, now U.S. Pat. No. 7,647,929, which issued on Jan. 19, 2010, which are incorporated herein by reference in their entirety for all purposes. 
     
    
     TECHNICAL FIELD 
       [0002]    The present disclosure, according to one embodiment, relates to medical device tubes, e.g., tracheostomy tubes, used in medical applications, and more particularly, to more securely attaching an inner cannula to an outer cannula. 
       BACKGROUND 
       [0003]    This section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present invention, which are described and/or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present invention. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art. 
         [0004]    A medical device tube may include an outer cannula (slender tube that may be inserted into a body cavity) attached to a head base connector. The head base connector and outer cannula are adapted for insertion of a disposable inner cannula. One example of a medical device tube is a tracheostomy tube. The tracheostomy tube may have a curved “L” shape and the head base connector may be attached to a swivel neck plate/flange. The tracheostomy tube provides an artificial airway for access to the patient&#39;s airway for airway management. The tracheostomy tube is introduced into a tracheotomy incision in the patient&#39;s neck that provides access to the trachea. The tracheostomy tube may be secured by a swivel neck plate/flange that may be connected to a tracheostomy tube holder or neck strap, thus securing this artificial airway for spontaneous or mechanical ventilation of the patient. 
         [0005]    The inner cannula may be inserted into the head base connector and outer cannula after the tracheostomy tube has been placed into the patient&#39;s trachea. This inner cannula typically includes a connector for quick removal of the inner cannula from the outer cannula, e.g., the inner cannula connector removably attaches to the head base connector, so that the inner cannula may be removed quickly if an obstruction, e.g., plug of mucus, sputum, etc., is formed. For example, a snap connector may be used to attached the inner cannula to the outer cannula. A mechanical ventilator hose may be removably coupled to the inner cannula to assist the patient in breathing. However, if the inner cannula is twisted and/or put into radial torsion during use, e.g., caused by movement of the ventilator hose connected thereto, the snap connector may disengage and allow the inner cannula to withdraw from the outer cannula. 
       SUMMARY 
       [0006]    Improving the reliability of attachment and continued attachment retention of the inner cannula to the outer cannula may be desired. Also, an added benefit would be to do so without having to change existing designs for the inner cannula and connector. 
         [0007]    According to a specific example embodiment of this disclosure, a medical device tube includes an outer cannula connector having a locking flange and opposing support ears; an outer cannula coupled to the outer cannula connector; an inner cannula connector having locking ears; and an inner cannula coupled to the inner cannula connector; wherein the inner cannula is adapted for insertion into the outer cannula connector and outer cannula such that the locking ears hold onto the locking flange of the outer cannula connector, wherein the opposing support ears substantially prevent rotation of the inner cannula connector in the outer cannula connector. 
         [0008]    According to another specific example embodiment of this disclosure, a tracheostomy air passage system has a tracheostomy tube including an outer cannula connector having a locking flange and opposing support ears, an outer cannula coupled to the outer cannula connector, an inner cannula connector having locking ears, and an inner cannula coupled to the inner cannula connector, wherein the inner cannula is adapted for insertion into the outer cannula connector and outer cannula such that the locking ears hold onto the locking flange of the outer cannula connector, wherein the opposing support ears substantially prevent rotation of the inner cannula connector in the outer cannula connector; a ventilator hose coupled to the inner cannula connector; and a ventilator coupled to the ventilator hose. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    A more complete understanding of the present disclosure may be acquired by referring to the following description taken in conjunction with the accompanying drawings wherein: 
           [0010]      FIG. 1  illustrates a schematic diagram of a patient ventilation system; 
           [0011]      FIG. 2  illustrates a schematic diagram of an outer cannual connector comprising a locking flange having opposing support ears, according to a specific example embodiment of the present disclosure; 
           [0012]      FIG. 3  illustrates a schematic diagram of an inner cannula connector coupled to the outer cannual connector shown in  FIG. 2 ; 
           [0013]      FIG. 4  illustrates an exploded assembly view schematic diagram of the outer cannula connector shown in  FIG. 2 ; 
           [0014]      FIG. 5  illustrates a schematic diagram of an outer cannula connector without an inner cannula inserted; 
           [0015]      FIG. 6  illustrates a schematic diagram of an inner cannula connector having locking ears supported by opposing sets of support ears of the outer cannula connector, according to a specific example embodiment of the present disclosure; 
           [0016]      FIG. 7  illustrates a schematic diagram of an inner cannula connector having locking ears with slots adapted for receiving opposing support ears of an outer cannula connector, according to another specific example embodiment of the present disclosure; 
           [0017]      FIG. 8  illustrates a schematic diagram of the inner cannula connector shown in  FIG. 6 ; 
           [0018]      FIG. 9  illustrates a schematic diagram of an opposite view of the inner cannula connector shown in  FIG. 6 ; 
           [0019]      FIG. 10  illustrates a schematic diagram of an outer cannula connector comprising a locking flange having opposing support ears, according to the another specific example embodiment of the present disclosure; 
           [0020]      FIG. 11  illustrates a schematic diagram of the outer cannula connector shown in  FIG. 10  and inner cannula connector shown in  FIGS. 7-9  coupled together; 
           [0021]      FIG. 12  illustrates a schematic side view diagram of the outer and inner cannula connectors shown in  FIG. 10 ; 
           [0022]      FIG. 13  illustrates another schematic diagram side view of the outer and inner cannula connectors shown in  FIG. 10 ; and 
           [0023]      FIG. 14  illustrates a schematic diagram back view of the outer cannula connector shown in  FIG. 10  with the inner cannula locking ears engaging the locking flange of the outer cannula connector. 
       
    
    
       [0024]    While the present disclosure is susceptible to various modifications and alternative forms, specific example embodiments thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the description herein of specific example embodiments is not intended to limit the disclosure to the particular forms disclosed herein, but on the contrary, this disclosure is to cover all modifications and equivalents as defined by the appended claims. 
       DETAILED DESCRIPTION 
       [0025]    Referring now to the drawings, the details of specific example embodiments are schematically illustrated. Like elements in the drawings will be represented by like numbers, and similar elements will be represented by like numbers with a different lower case letter suffix. 
         [0026]    Referring to  FIG. 1 , depicted is a schematic diagram of a patient ventilation system, according to a specific example embodiment of the present disclosure. A patient  102  has a stoma  114  (opening) leading to his/her trachea  116  in which an outer cannula  104  is inserted. The outer cannula  104  may have a curved portion  105 , e.g., L shape. A neck flange  106  may be attached to the patient&#39;s  102  neck, e.g., by tape and/or straps, etc. (not shown). A ventilator hose  108  may couple a ventilator  110  to a hose coupling  118 . Optionally, an inflation collar  112  may be proximate to the outer wall of the outer cannula  104 , and an inflation lumen  120  may be within the wall of the outer cannula  104  or proximate thereto. An air valve port  122  may be used in combination with the inflation lumen  120  and the inflation collar  112  for, when inflated, creating an air and/or liquid sealing function between the outer cannula  104  and the trachea  116  air passage. The inflation collar  112  may also position the outer cannula  104  in the trachea  116 . More than one lumen may be in the wall of the cannula  104  and the additional lumens therein may be used for various other purposes. The inflation collar  112  may be inflated with a fluid, e.g., air, nitrogen, saline, water, etc. 
         [0027]    Referring to  FIG. 2 , depicted is a schematic diagram of an outer cannual connector comprising a locking flange having opposing support ears, according to a specific example embodiment of the present disclosure. An outer cannula connector, generally represented by the numeral  200 , comprises an outer cannula locking flange  202 , a first set of support ears  204   a  and  204   b  and a second set of support ears  206   a  and  206   b . The outer cannula connector may be coupled to a proximal end of the outer cannula  104 . The second set of support ears  206  are opposite to the first set of support ears  204 , e.g., the first and second sets of support ears  204  and  206 , respectively, are on opposing sides of each other. Shown are opposing pairs of support ears, however, a single first support ear  204   a  and a single second support ear  206   a  opposing the single first support ear  204   a  may be utilized in accordance with the teachings of this disclosure. It is also contemplated and within the scope of this disclosure that a plurality of opposing support ears may be utilized. 
         [0028]    Referring to  FIG. 3 , depicted is a schematic diagram of an inner cannula connector coupled to the outer cannual connector illustrated in  FIG. 2 . An inner cannula connector  310  has locking ears  312  that may be adapted to engage the outer cannula locking flange  202 . The inner cannula  314  may be inserted into an opening (not shown) in the outer cannula connector  200 . Inner cannula connector  310  may be coupled to a proximal end of an inner cannula  314 . The inner cannula connector  310  may be adapted for coupling to the ventilator hose  108  (see  FIG. 1 ). The inner cannula connector  310  may comprise locking ears  312 . A portion of the locking ears  312  and a portion of the inner cannula connector  310  may be placed between the first and second sets of opposing support ears  204  and  206 , respectively, and the locking ears  312  may hold, e.g., grasp, clutch, snap, clip, etc., onto the outer cannula locking flange  202 . The inner cannula connector  310  may be adapted for coupling to a speaking valve (not shown). 
         [0029]    The first and second sets of opposing support ears  204  and  206 , respectively, may keep the locking ears  312  substantially aligned therewith, thus preventing rotation of the inner cannula connector  310  within the outer cannula connector  200 . The first and second sets of opposing support ears  204  and  206 , respectively, may also reduce axial misalignment between the outer cannula flange  200  and the inner cannula connector  310 , by preventing substantial torsional radial twisting of the inner cannula connector  310  with respect the outer cannula connector  200 . The possibility of locking ears  312  undesirably disengaging, e.g., unlocking, from flange  202  because of rotational and/or radial twisting of the inner cannula connector  310  may be substantially reduced. The inner cannula connector  310  may be, for example but not limited to, an industry standard inner cannula connector  310  having locking ears  312  that are adapted to lock over, e.g., snap over, the flange  202  ( FIG. 2 ) of a mating outer cannula connector  200 . The inner cannula  314  and associated connector  310  may be disposable or reusable. The outer cannula  104  and associated connector  200  may be disposable or reusable. 
         [0030]    Referring to  FIG. 4 , depicted is an exploded assembly view schematic diagram of the outer cannula connector  200  shown in  FIG. 2 . The outer cannula connector  200  may be comprised of a snap-flange hood  418  and a cannula coupling connector  416 . The cannula coupling connector  416  may be attached to a proximal end of the outer cannula  104 . The snap-flange hood  418  may be comprised of opposing support ears, e.g., the first and second sets of opposing support ears  204  and  206 , respectively, and the flange  202 . 
         [0031]    The snap-flange hood  418  and cannula coupling connector  416  may be attached together by, for example but not limited to, adhesive bonding, ultrasonic bonding, heat staking, solvent bonding; mechanical snaps, threads and pins, etc. Energy directors  420  may be used when the material used for the extended snap-flange hood  418  and coupling flange  416  are ultrasonically welded or heat staked together. The energy directors  420  may be eliminated when the assembly methods used, e.g., solvent bonding, adhesive bonding, or heat staking, spin welding, mechanical snaps or threads, pins, etc., may fuse the snap-flange hood  418  and cannula coupling connector  416  together. Materials that may be used for the cannula coupling connector  416  and snap-flange hood  418  may be, for example but not limited to, polyvinyl chloride (PVC), polycarbonate, ABS, polystyrene, or other plastic material, metal, carbon fiber, etc. 
         [0032]    Referring to  FIG. 5 , depicted is a schematic diagram of an outer cannula connector without an inner cannula inserted. The neck flange  106  may be positioned in, e.g., snapped onto, the outer cannula connector  200 . 
         [0033]    Referring to  FIG. 6 , depicted is a schematic diagram of an inner cannula connector having locking ears supported by opposing sets of support ears of the outer cannula connector, according to a specific example embodiment of the present disclosure. In this specific example embodiment, the inner cannula locking ears  312  fasten or connect with, e.g., snap, over flanges  202  (see  FIGS. 2 and 3 ) that are between the first and second sets of support ears  204  and  206 , respectively. Placing the locking ears  312  of the inner cannula connector  310  between the first and second sets of opposing support ears  204  and  206 , respectively, substantially prevents the locking ears  312  from undesirably disengaging, e.g., unlocking, from the flanges  202 , for example, because of twisting and/or radial torque on the inner cannula connector  310 . 
         [0034]    Referring now to  FIGS. 7-9 , depicted are schematic diagrams of an inner cannula connector having locking ears with slots adapted for receiving opposing support ears of an outer cannula connector, according to another specific example embodiment of the present disclosure. An inner cannula connector  310   a  has locking ears  312   a  that may be adapted to engage an outer cannula locking flange (e.g., locking flange  202  or locking flange  1012  shown in  FIGS. 10-14 ). The inner cannula connector  310   a  is attached to a proximal end of an inner cannula and the inner cannula may be inserted into an outer cannula connector (e.g., connector  200  or connector  1000  of  FIG. 10 ). The inner cannula connector  310   a  may be adapted for coupling to the ventilator hose  108  (see  FIG. 1 ). The locking ears  312   a  may hold, e.g., grasp, clutch, snap, clip, etc., onto the outer cannula locking flange  202  or locking flange  1012 . When placed onto the outer cannula locking flange  202 , a portion of the locking ears  312   a  and a portion of the inner cannula connector  310   a  may be placed between the first and second sets of opposing support ears  204  and  206 , respectively. When placed onto the outer cannula locking flange  1012  shown in  FIGS. 10-14 , slots  722  and  724  may receive opposing support ears  1014  as shown in  FIGS. 10-14 . Thus, the inner cannula connector  310   a  may be used with either the outer cannula connector  200  described hereinabove, or an outer cannula connector  1000  described hereinafter. 
         [0035]    Referring now to  FIG. 10 , depicted is schematic diagram of an outer cannula connector comprising a locking flange having opposing support ears, according to the another specific example embodiment of the present disclosure. An outer cannula connector, generally represented by the numeral  1000 , comprises an outer cannula locking flange  1012  and opposing support ears  1014 , e.g., tabs, prongs, pins, etc. The outer cannula connector  1014  may be coupled to a proximal end of the outer cannula  104 . 
         [0036]    Referring now to  FIGS. 11-14 , depicted are schematic diagrams at various views of the outer cannula connector shown in  FIG. 10  and inner cannula connector shown in  FIGS. 7-9  coupled together. The opposing support ears  1014  may slidingly engage into the slots  722  and  724  ( FIGS. 7-9 ) in the locking ears  312   a  of the inner cannula connector  310   a . The opposing support ears  1014  may substantially prevent the locking ears  312   a  from twisting off of the locking flange  1012  due to, for example, twisting and/or radial torque on the inner cannula connector  310   a .  FIG. 12  illustrates a schematic side view diagram of the outer and inner cannula connectors shown in  FIG. 10 .  FIG. 13  illustrates another schematic diagram side view of the outer and inner cannula connectors shown in  FIG. 10 .  FIG. 14  illustrates a schematic diagram back view of the outer cannula connector shown in  FIG. 10  with the inner cannula locking ears engaging the locking flange of the outer cannula connector. 
         [0037]    Specific example embodiments, according to this disclosure may restrict axial rotation from a centered position for example, but not limited to, at a minimum of about +/−0.5 degrees, as much as +/−2 degrees, and possibly as much as +/−10 degrees rotation. Specific example embodiments, according to this disclosure may restrict longitudinal movement for example, but not limited to, at a minimum of about +/−0.005 inches, as much as +/−0.010 inches, and possibly as much as +/−0.10 inches without substantial disengagement. 
         [0038]    While embodiments of this disclosure have been depicted, described, and are defined by reference to example embodiments of the disclosure, such references do not imply a limitation on the disclosure, and no such limitation is to be inferred. The subject matter disclosed is capable of considerable modification, alteration, and equivalents in form and function, as will occur to those ordinarily skilled in the pertinent art and having the benefit of this disclosure. The depicted and described embodiments of this disclosure are examples only, and are not exhaustive of the scope of the disclosure.