Abstract:
A device for adapting a transtracheal catheter to a tracheostomy tube includes a plurality of projections for engaging a security flange of the transtracheal catheter. The device provides for proper orientation of a beveled end of the catheter tube when the security flange is oriented as directed with it longest flat side up. A method of adapting a transtracheal catheter to a patient&#39;s tracheostomy tube is also provided for providing the delivery of heated and/or humidified gas to tracheotomized patients and/or for weaning a ventilator-dependent patient from the ventilator.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     The present application claims the benefit of U.S. Provisional Patent Application No. 60/616,488 filed on Oct. 5, 2004 and entitled “Tracheal Oxygen Adaptor Cap,” which is incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates to a medical device that operates in association with a tracheostomy tube, and more particularly, a device for adapting a catheter to a tracheostomy tube.  
       BACKGROUND OF THE INVENTION  
       [0003]     U.S. Pat. No. 5,515,844 entitled “Method and Apparatus for Weaning Ventilator-Dependent Patients,” incorporated herein by reference in its entirety, discloses several adapter devices used in connection with methods for weaning ventilator-dependent patients who access oxygen from the ventilator through a tracheostomy tube. The methods include deflating the cuff on the patient&#39;s tracheostomy tube and supplying a continuous flow of oxygen or an air mixture through a transtracheal catheter fitted into the patient&#39;s tracheostomy tube and into the patient&#39;s lungs. In addition to weaning a ventilator-dependent patient from a ventilator, it has also been found that tracheotomized patients may benefit from receiving heated and/or humidified gas, such as oxygen, air, air/oxygen blend, etc., from a transtracheal catheter.  
         [0004]     The adapter devices of the &#39;844 patent include a tapered plug or cap to block the opening of the tracheostomy tube. However, the adapter devices of the &#39;844 patent are generally not configured to directly attach to the security flange of the transtracheal catheter. More particularly, the adapter devices of the &#39;844 patent are not configured to directly interconnect with the security flange of the transtracheal catheter sold under the trademark SCOOP® and manufactured by Transtracheal Systems, Inc. of Englewood, Colo., and described in U.S. Pat. Nos. 5,090,408 and 5,181,509, incorporated herein by reference in their entirety. As shown in  FIG. 1 , the transtracheal catheter  10  sold under the trademark SCOOP® includes a tube  14  having a connector  18  at is proximal end for attachment to an oxygen/air supply. In addition, the transtracheal catheter  10  has a distal end having a beveled end  22 . The transtracheal catheter  10  is made of a bio-polymer of 70-90 Shore A durometer hardness that resists kinking and crushing. The transtracheal catheter  10  further includes a security flange  26  having two holes  30  for accepting a small chain (not shown) for maintaining the position of the transtracheal catheter  10  around the patient&#39;s neck.  
         [0005]     Referring now to  FIG. 2 , a tracheostomy tube assembly  34  of the prior art is shown. The assembly  34  includes an outer cannula  38  and a sealing balloon  42  located adjacent the distal end  46  of the outer cannula  38 . Positioned adjacent the proximal end  50  of the outer cannula  38  is a swivel neck flange  54  that is used to secure the assembly  34  to the neck of the patient. A flexible inflation tube  58  extends from the proximal end  50  of the outer cannula  38  to receive air to inflate the balloon  42  for sealing the outer cannula  38  within the trachea of the patient.  
         [0006]     Referring now to  FIG. 3 , the outer cannula  38  includes a coupling mechanism or connector  62  for removably attaching an inner cannula  66  to the outer cannula  38 . Comparing  FIG. 3  to  FIG. 2 , the inner cannula  66  is partially removed from within the outer cannula  38 . The inner cannula  66  includes a tube fitting  70  at its proximate end. The inner cannula  66  is designed to be completely removed from within the outer cannula  38  in order to allow the inner cannula  66  to periodically be cleaned and thereby provide a clean and clear passage for the flow of air to the patient.  
         [0007]     While the adapter devices of the &#39;844 patent may be utilized along a position of the tube  14  of the transtracheal catheter  10 , the adapter devices of the &#39;844 patent do not secure the transtracheal catheter in place. Rather, the transtracheal catheter is typically independently secured by a chain around the patient&#39;s neck. More specifically, the adapter devices of the &#39;844 patent do not engage the security flange  26  of a transtracheal catheter  10 . Therefore, it would be advantageous to provide a tracheostomy tube adapter for direct use with the security flange  26  of the transtracheal catheter  10  sold under the trademark SCOOP®. In addition, it would be advantageous to provide a tracheostomy tube adapter that properly orients the beveled end  22  of the transtracheal catheter  10  within the tracheostomy tube assembly  34 .  
       SUMMARY OF THE INVENTION  
       [0008]     The present invention solves the above-mentioned deficiencies by providing an adapter device for adapting a transtracheal catheter to a tracheostomy tube. Transtracheal catheters typically include a tube and a security flange connected to the tube. In accordance with embodiments of the present invention, an adapter device is provided comprising a perimeter wall, wherein the perimeter wall provides a means for engaging the tracheostomy tube, and in at least one embodiment, forms a friction fit with the tracheostomy tube. The perimeter wall may comprise a shape allowing the adapter to either plug into or fit over a portion of the tracheostomy tube. The perimeter wall also includes an aperture or a means for receiving the tube of the transtracheal catheter. The adapter device further includes at least one projection connected to the perimeter wall, wherein the projection is for engaging the security flange of the transtracheal catheter. In accordance with at least some of the embodiments of the present invention, the adapter device may further comprise at least one flange portion connected to the perimeter wall, wherein at least a portion of the flange portion has a shape substantially matching a portion of a shape of the security flange. This allows the security flange of the transtracheal catheter and the adapter device to be quickly aligned in a proper orientation relative to each other. In addition, the adapter device may further comprise at least a second projection connected to the perimeter wall, wherein the second projection is for engaging a different portion of the security flange of the transtracheal catheter than the first projection. In accordance with at least some of the embodiments of the present invention, the two projections are located on opposing sides of the perimeter wall. In addition, in accordance with at least some of the embodiments of the present invention, the projections are positioned to prevent rotation and/or longitudinal movement of the transtracheal catheter relative to the tracheostomy tube. In accordance with at least some of the embodiments of the present invention, the projection comprises a center that is aligned within a width of the perimeter wall. In accordance with at least some of the embodiments of the present invention, the projection includes at least a first portion having a first diameter and a second portion having a second diameter, wherein the first diameter is greater than the second diameter. In addition, in accordance with at least some of the embodiments of the present invention, the projection may include at least a third portion having a third diameter, wherein the first portion is located between the second and third portions, and wherein the first diameter is greater than the third diameter.  
         [0009]     In accordance with at least some of the embodiments of the present invention, a method of adapting a transtracheal catheter to a patient&#39;s tracheostomy tube is also provided for providing the delivery of heated and/or humidified gas (oxygen, air, air/oxygen blend, etc.) to tracheotomized patients and/or for weaning a ventilator-dependent patient from the ventilator. The method includes (1) ventilating the patient with a tracheostomy tube having a proximal opening connected to a ventilator, a distal opening inserted through an incision into the patient&#39;s trachea, and an inflatable balloon about the tracheostomy tube adjacent the distal opening for sealing the region between the tracheostomy tube and the patient&#39;s trachea; (2) disconnecting the ventilator from the proximal opening of the tracheostomy tube; (3) deflating the balloon so that the patient can breathe spontaneously through the patient&#39;s upper airway; (4) removably inserting a transtracheal catheter through the adapter and into the tracheostomy tube; (5) connecting an adapter to the proximal opening of the tracheostomy tube; (6) engaging at least one projection of the adapter with a security flange of the transtracheal catheter; and (7) supplying a prescribed flow of an oxygen/air/gas mixture through the transtracheal catheter and into the lungs of the patient. Prior to engaging the projections, the method may further comprise aligning a flange portion of the adapter with the security flange to properly orient the adapter. In addition, in accordance with embodiments of the present invention, the step of connecting an adapter to the proximal opening of the tracheostomy tube may be performed prior to the step of removably inserting a transtracheal catheter through the tracheostomy tube, and the method may further comprise removably inserting the transtracheal catheter into the adapter.  
         [0010]     Various embodiments of the present invention are set forth in the attached figures and in the detailed description of the invention as provided herein and as embodied by the claims. It should be understood, however, that this Summary of the Invention may not contain all of the aspects and embodiments of the present invention, is not meant to be limiting or restrictive in any manner, and that the invention as disclosed herein is and will be understood by those of ordinary skill in the art to encompass obvious improvements and modifications thereto.  
         [0011]     Additional advantages of the present invention will become readily apparent from the following discussion, particularly when taken together with the accompanying drawings. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0012]     Several drawings have been developed to assist with understanding the invention. Following is a brief description of the drawings that illustrate the invention and its various embodiments.  
         [0013]      FIG. 1  is a perspective view of a transtracheal catheter sold under the trademark SCOOP®;  
         [0014]      FIG. 2  is a perspective view of a tracheostomy tube known in the prior art;  
         [0015]      FIG. 3  is a perspective view of the tracheostomy tube shown in  FIG. 2 , and further illustrating the inner cannula of the tracheostomy tube;  
         [0016]      FIG. 4  is a perspective view of an embodiment of the present invention;  
         [0017]      FIG. 5  is a cross-section view of the device shown in  FIG. 4 ;  
         [0018]      FIG. 6  is a front elevation view of the device shown in  FIG. 4 ;  
         [0019]      FIG. 7  is a top elevation view of the device shown in  FIG. 4 ;  
         [0020]      FIG. 8  is a rear elevation view of the device shown in  FIG. 4 ;  
         [0021]      FIG. 9  is an exploded perspective view of an assembly including a transtracheal catheter, tracheostomy tube, and an adapter device in accordance with embodiments of the present invention, the adapter for interconnecting the transtracheal catheter and the tracheostomy tube; and  
         [0022]      FIG. 10  is a perspective view of the fully assembled transtracheal catheter, tracheostomy tube, and adapter shown in  FIG. 9 . 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]     Referring now to  FIGS. 4-10 , in accordance with embodiments of the present invention, a device for adapting a transtracheal catheter to a tracheostomy tube is shown. The present invention comprises an adapter cap  74  for attachment to the connector  62  at the proximal end  50  of the tracheostomy tube assembly  34 . Accordingly, the cap  74  is a device to allow the transtracheal catheter  10  of  FIG. 1  to be inserted directly into the tracheostomy tube assembly  34  of  FIGS. 2 and 3 after removal of the inner cannula  66  from the outer cannula  38 .  
         [0024]     The adapter cap  74  includes a cylindrical wall  78  having an inner surface  82  and an outer surface  86 . In addition, the cap  74  includes an end wall  90 , wherein the end wall  90  includes an aperture  94  for receiving the tube  14  of the transtracheal catheter  10 . The end wall  90  and the cylindrical wall  78  act as a perimeter wall that define a chamber  98  that acts as a receptacle for receiving the connector  62  at the proximal end  50  of the tracheostomy tube assembly  34 . When the cap  74  is slipped over the connector  62  of the tracheostomy tube assembly  34 , the inner surface  82  forms a friction fit with the outer surface of the connector  62 . As one skilled in the art will appreciate, although not shown, the cap  74  may also comprise a plug that fits into the interior of the connector  62  or the proximal end  50  of the tracheostomy tube, thereby creating a friction fit with the inside of the connector or tracheostomy tube instead of the outside of the connector.  
         [0025]     Contiguous with the end wall  90 , the adapter cap  74  preferably includes first and second flange portions  102 . The flange portions  102  extend beyond the outer surface  86  of the cylindrical wall  78  and provide a portion of the cap  74  for grasping during the process of fitting the cap  74  to the tracheostomy tube assembly  34 . In addition, the flange portions  102  provide an outline or template that substantially matches at least a portion of the shape of the security flange  26  of the transtracheal catheter  10 , thereby aiding the person placing the transtracheal catheter  10  into the tracheostomy tube assembly  34  because the shapes of the surfaces can be matched and aligned. This reduces the time for the conversion process, thereby improving patient health because of less time without oxygen. In addition, the speed of the conversion process also aids in decreasing possible mental anxiety and emotional stress to the patient, where such stress can be associated with a breathing problem or a fear of insufficient oxygen during the conversion process. Referring to  FIG. 6 , from a horizontal, the sides of the flange portions  102  are offset from a horizontal at a side angle a, where the side angle a substantially matches the side angle of the flange  26  of the transtracheal catheter  10 . In accordance with the preferred embodiments of the present invention, the side angle α is about 50 degrees.  
         [0026]     As best seen in  FIGS. 5 and 7 , extending from the front surface  106  of the cap  74  is at least one projection  110 , and more preferably, two projections  110 . The projections  110  are sized to engage the holes  30  of the security flange  26  of the transtracheal catheter  10 . In accordance with at least some embodiments of the present invention, the two projections  110  are located on substantially opposite sides of the cylindrical wall  78  that is located on the opposing side of the end wall  90  of the security flange  26 . The projections  110  are preferably positioned to prevent rotation and/or longitudinal movement of the transtracheal catheter relative to the tracheostomy tube. Thus, the projections  110  serve not only as a means to secure the security flange  26  to the adapter cap  74 , but the projections  110  also serve to prevent movement of the transtracheal catheter relative to the tracheostomy tube.  
         [0027]     Still referring to  FIGS. 5 and 7 , in accordance with at least some embodiments of the present invention, the projections  110  include three sections along their longitudinal length, including an outer portion  114 , a middle portion  118 , and an inner portion  122 , wherein the middle portion  118  is located between the outer portion  114  and the inner portion  122 , and wherein the middle portion  118  has a greater outside diameter than the outer portion  114  and the inner portions  122 . The greater outside diameter of the middle portion  118  helps secure the security flange  26  of the transtracheal catheter  10  to the cap  74  because the projections  110  are advanced through the holes  30  of the security flange  26  until the outer surface or wall of the security flange  26  passes by the middle portion  118  of the projections  110 . More particularly, the pliable material forming the security flange  26  allows the material to expand around the greater outside diameter of the middle portion  118  of the projections  110 , wherein the middle portion  118  of the projections  110  retains the security flange  26  to the cap  74 . In accordance with at least some of the embodiments of the present invention, the center “c” of each projection  110  is aligned to intersect the cylindrical wall  78 , thereby improving the structural integrity of the cap  74 .  
         [0028]     The cap  74  is preferably formed of a medical grade polyurethane of between about 70 to 90 Shore A durometer hardness, and more preferably, is formed of a medical grade polyurethane of about 80 Shore A durometer hardness. However, as those skilled in the art will appreciate, the cap may be formed of other materials, including composites and combinations of materials used to form different portions of the cap  74 .  
         [0029]     Referring now to  FIG. 9 , an exploded view of a transtracheal catheter sold under the trademark SCOOP®, a tracheostomy tube, and a cap  74  in accordance with embodiments of the present invention are shown. As can be seen from  FIG. 9 , the inner surface  82  of the cylindrical wall  78  is aligned to slide over the outer surface of the connector  62  of the tracheostomy tube. More particularly, the inner cannula  66  is preferably removed from the outer cannula  38 , and then the inner surface  82  of the cylindrical wall  78  is aligned to slide over the connector  62 . In addition, as described above, the flange portions  102  provide an outline or template that substantially matches a portion of the shape of the security flange  26  of the transtracheal catheter  10 , thereby aiding the person placing the transtracheal catheter  10  into the tracheostomy tube assembly  34  by providing a visual aid for aligning the flange  26  with the adapter cap  74 . During assembly, the tube  14  of the transtracheal catheter is placed though aperture  94  of the cap  74 .  
         [0030]     Referring now to  FIG. 10 , upon assembly, at least a portion of the projections  110  are placed through the holes  30  of the security flange  26  until the outer surface or wall of the security flange  26  passes by the middle portion  118  of the projections  1   10 . With the transtracheal catheter  10  fitted to the cap  74 , and the cap  74  fitted to the tracheostomy tube, the assembly is complete. The adapter cap  74  permits the tracheostomy tube  34  to readily be transformed for use with a transtracheal catheter.  
         [0031]     In accordance with embodiments of the present invention, a method of adapting a transtracheal catheter to a patient&#39;s tracheostomy tube is provided for the delivery of heated and/or humidified gas (oxygen, air, air/oxygen blend, etc.) to tracheotomized patients and/or for weaning a ventilator-dependent patient from the ventilator. The method employs a transtracheal tube or catheter that is inserted through the patient&#39;s tracheostomy tube to augment the flow of oxygen, air, or gas mixtures to the lungs as the patient breathes spontaneously. The gas delivery and/or weaning process involves disconnecting the ventilator from the tracheostomy tube; deflating the tracheostomy tube balloon so that the patient can breathe spontaneously through the upper airway; removably inserting a transtracheal catheter or tube through an adapter and into the tracheostomy tube; connecting an adapter to the proximal opening of the tracheostomy tube; engaging at least one projection of the adapter with a security flange of the transtracheal catheter; and supplying a prescribed flow of an oxygen/air/gas mixture through the transtracheal catheter and into the lungs of the patient. The method may also include the step of aligning a flange portion of the adapter with the security flange to properly orient the adapter. In addition, in accordance with at least some embodiments of the present invention, the inner cannula, if present, is removed from the outer cannula of the tracheostomy tube assembly prior to insertion of the transtracheal catheter into the tracheostomy tube.  
         [0032]     The present invention, in various embodiments, includes components, methods, processes, systems and/or apparatus substantially as depicted and described herein, including various embodiments, subcombinations, and subsets thereof. Those of skill in the art will understand how to make and use the present invention after understanding the present disclosure. The present invention, in various embodiments, includes providing devices and processes in the absence of items not depicted and/or described herein or in various embodiments hereof, including in the absence of such items as may have been used in previous devices or processes, e.g., for improving performance or achieving ease and\or reducing cost of implementation.  
         [0033]     The foregoing discussion of the invention has been presented for purposes of illustration and description. The foregoing is not intended to limit the invention to the form or forms disclosed herein. In the foregoing Detailed Description of the Invention, for example, various features of the invention are grouped together in one or more embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the following claims are hereby incorporated into this Detailed Description Of The Invention, with each claim standing on its own as a separate preferred embodiment of the invention.  
         [0034]     Moreover though the description of the invention has included description of one or more embodiments and certain variations and modifications, other variations and modifications are within the scope of the invention, e.g., as may be within the skill and knowledge of those skilled in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative embodiments to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.