Patent Publication Number: US-2013228179-A1

Title: Airway management apparatus

Description:
BACKGROUND OF THE INVENTION 
     1. Technical Field 
     The present disclosure relates generally to airway management devices. More particularly, the disclosure relates to an airway management apparatus for use in oxygenating a patient during endotracheal tube intubation and/or extubation. 
     2. Background Information 
     Airway exchange catheters are often used to oxygenate a patient during endotracheal tube (ETT) exchange. Removal of an endotracheal tube from the trachea of a patient is commonly referred to as extubation. Insertion of an endotracheal tube is commonly referred to as intubation. After an ETT has been positioned in the trachea of the patient for a period of time, a physician may determine that the existing ETT should be removed and exchanged for a new ETT, or in some instances, cleaned and repositioned in the trachea. The necessity to remove an existing ETT from the trachea of a patient and replace it with a new, or a cleaned, ETT may arise from, among other things, the physician&#39;s desire to utilize an ETT of a different size, the displacement of the existing ETT, or the malfunction of the existing ETT resulting from conditions such as blockage, e.g., as may be caused by patient mucous. 
     Proper placement and use of airway exchange catheters during endotracheal tube replacement is well known in the art. One particularly well-known method for replacing an ETT while maintaining oxygenation of the patient via an airway exchange catheter is described in U.S. Pat. No. 5,052,386, incorporated by reference herein. According to the method described in the &#39;386 patent, the existing ETT is disconnected from a ventilator, and the airway exchange catheter is connected to the ventilator by way of a removable connector at the proximal end of the airway exchange catheter. The catheter is then inserted into the lumen of the placed endotracheal tube. The connector is configured to allow rapid connection, and disconnection, between the airway exchange catheter and the ventilator. The airway exchange catheter may be disconnected from the ventilator via the removable connector as the ETT is removed from about the catheter. A replacement ETT may then be inserted over the airway exchange catheter, and the catheter is reconnected to the ventilator utilizing the removable connector. Once the replacement ETT is determined to be properly positioned in the trachea, the airway exchange catheter is disconnected from the ventilator and removed from the interior space of the ETT. The ventilator is then connected to the replacement ETT. 
     It is sometimes desirable to position a wire guide in either the left or right mainstem bronchus during airway management, and to maintain the wire guide in this position during the course of treatment. Maintaining a wire guide in this manner secures access to the desired airway bronchus, and thereby facilitates the later access of a working catheter (e.g., an endobronchial blocker catheter) by providing a conduit into the bronchus. When an airway exchange catheter is inserted into an airway which has previously been secured by a wire guide, the wire guide extends through the lumen of the airway exchange catheter. However, when it is desired to oxygenate the patient via the airway exchange catheter having the removable connector on the proximal end of the catheter as described above, the presence of the wire in the catheter lumen obstructs the passage of the ventilating fluid therethrough. Additionally, the presence of the wire extending out the proximal end of the airway exchange catheter obstructs the ability to securely connect the airway exchange catheter to the ventilator via the removable connector described above. 
     It is desired to provide an apparatus for use in airway management, such as endotracheal tube replacement, that overcomes the problems associated with prior art catheters. More particularly, it is desired to provide an apparatus that permits use of a removable connector with an airway exchange catheter that is suitable for oxygenating the patient even when the catheter has been inserted over a wire guide. 
     BRIEF SUMMARY 
     The present invention addresses the shortcomings of the prior art. In one form thereof, the invention comprises an airway management apparatus for engagement with a catheter for oxygenation of a patient. The airway management apparatus includes a generally hollow main body having a plurality of ports open to an interior space thereof. The main body has a major axis, a first port extending in a proximal direction from the main body along the major axis, a second port angularly offset from the major axis, and a third port extending in a distal direction from the main body wherein the third port is at least substantially in-line with the first port along the major axis. The third port comprises a connector for engagement with a proximal end of the catheter. The connector comprises a plurality of radially compressible members extending in a distal direction, wherein the compressible members are circumferentially aligned to define a chamber for receiving the catheter proximal end. The third port further comprises an axially movable member positioned for selectively compressing a distal end portion of the compressible members around the catheter proximal end, and for releasing the compressible members from around the catheter proximal end. 
     In another form thereof, the invention comprises an airway management system for use in oxygenating a patient, such as during endotracheal tube cleaning and/or replacement. A catheter has a proximal end, a distal end, a passageway extending therethrough, and an outer surface dimensioned to be received in a passageway through an endotracheal tube. An airway management apparatus comprises a generally hollow main body and a plurality of ports open to an interior space of the main body. The plurality of ports includes a first port disposed at a proximal portion of the apparatus, a second port, and a third port disposed at a distal portion of the apparatus. The third port is positioned substantially in-line with the first port along an axis of the apparatus. The third port comprises a connector sized and configured for releasably engaging the proximal end of the catheter. A wire guide may be configured to extend through the first port and the third port along the axis, and through the catheter when the catheter is engaged with the third port. 
     In still another form thereof, the invention comprises a method for oxygenating a patient during removal of an endotracheal tube, wherein a proximal end of the endotracheal tube is engaged with a ventilation apparatus and a distal end extends into the trachea of the patient. A multi-port airway apparatus is positioned for engagement with a catheter. The multi-port airway apparatus comprises a main body having a proximal first port, a second port, and a distal third port. The third port is at least substantially in-line with the first port, and comprises a connector member. A proximal end of the catheter is engaged with the connector member of the third port. The proximal end of the endotracheal tube end is disengaged from the ventilation apparatus, and the ventilation apparatus is engaged with the second port. A distal end of the catheter is passed through a passageway of the endotracheal tube, such that the catheter distal end extends beyond the distal end of the endotracheal tube. A guide device is passed through the first and third ports of the multi-port airway apparatus, and through a lumen of the catheter, such that a distal end of the guide device extends into the trachea. The endotracheal tube may be at least partially withdrawn from the trachea over the catheter and guide device. The proximal end of the catheter may be disengaged from the connector member of the third port, the airway apparatus may be withdrawn over the guide device, and the endotracheal tube may be withdrawn over the guide device. The airway apparatus may be re-aligned over the guide device, and the catheter proximal end may be re-engaged with the connector member to re-establish a flow of ventilating fluid to the patient. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a side view of a prior art connector that has been connected to the proximal end of an airway exchange catheter; 
         FIG. 2  is a side view of the prior art connector of  FIG. 1 , wherein the collar has been retracted to release the catheter from the connector; 
         FIG. 3  is a side view of an airway management apparatus according to an embodiment of the present invention; 
         FIG. 4  is a side view of the airway management apparatus as shown in  FIG. 3 , showing an airway exchange catheter locked at the distal end of the apparatus and a wire guide extending through the apparatus; 
         FIG. 5  is a longitudinal sectional view of the airway management apparatus with a catheter in the locked position as shown in  FIG. 4 ; 
         FIG. 5A  is an enlarged view of a portion of the distal port comprising a plurality of axially-extending fingers; 
         FIG. 5B  is an enlarged view of a portion of the distal port comprising an axially slidable collar; 
         FIG. 6  is a longitudinal sectional view sectional view of the airway management apparatus and catheter of  FIG. 4  in an unlocked position; 
         FIG. 7  is an alternative embodiment of the airway management apparatus of  FIG. 4 , also showing an airway exchange catheter locked at the distal end of the apparatus and a wire guide extending through the apparatus; and 
         FIG. 8  illustrates use of the airway management apparatus during exchange of an endotracheal tube in a patient. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     For purposes of promoting an understanding of the present invention, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It should nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. 
     In the following discussion, the terms “proximal” and “distal” will be used to describe the opposing axial ends of the airway management apparatus, as well as the axial ends of various components. The term “proximal” is used in its conventional sense to refer to the end of the apparatus (or component) that is closest to the operator during use of the apparatus. The term “distal” is used in its conventional sense to refer to the end of the apparatus (or component) that is initially inserted into the patient, or that is closest to the patient during use. 
       FIG. 1  is a side view of a prior art removable connector  100  of the type disclosed in the incorporated-by-reference U.S. Pat. No. 5,052,386. In  FIG. 1 , collar  107  has been advanced such that connector  100  is engaged with the proximal end of an airway exchange catheter  120 .  FIG. 2  is another side view of the prior art connector of  FIG. 1 . As explained below, collar  107  is retracted in  FIG. 2  to release catheter  120  from the connector. 
     In the example shown herein, the prior art removable connector of  FIGS. 1 and 2  includes a conventional 15 mm ventilator fitting portion  102  at a proximal end. Fitting portion  102  is sized and configured for connection to a mating fitting of a mechanical ventilation apparatus (not shown), in well-known fashion. A catheter fitting portion  104  is provided at the distal end of the connector for connection to the proximal end  122  of airway exchange catheter  120 . Catheter fitting portion  104  comprises a sleeve  105  having a plurality of fingers  106  extending in an axial direction therefrom. Fingers  106  are aligned in the catheter fitting portion in a manner to comprise a chamber for snugly receiving catheter proximal end  122 . Slidable collar  107  is positioned about fingers  106 . Collar  107  is axially movable (in the direction of the arrows in respective  FIGS. 1 and 2 ) between a distal (locked) position for engaging the catheter  120  as shown in  FIG. 1 , and a proximal (unlocked) position as shown in  FIG. 2  for disconnecting the catheter from connector  100 . 
     Some removable connectors known in the art include other known fittings in place of the 15 mm fitting portion  102 . For example, a threaded Luer lock fitting may be used in place of the 15 mm fitting portion. Such Luer lock fittings are commonly used, e.g., for connection to a jet ventilator when jet ventilation is desired instead of conventional mechanical ventilation. Removable connector  100  is typically formed of a hard plastic material, such as polycarbonate. Connectors such as those described above are commercially sold by Cook Medical, of Bloomington, Ind., as RAPI-FIT® connectors. Further description of removable connector  100  is provided in the incorporated-by-reference &#39;386 patent. 
       FIG. 3  is a side view of an airway management apparatus  10  according to an embodiment of the present invention. Airway management apparatus  10  includes a generally hollow main body  12 , and a plurality of ports that open to the generally hollow interior of main body  12 . In the non-limiting embodiment shown in  FIG. 3 , main body  12  includes ports  20 ,  30 , and  40 . 
     Port  20  extends in a proximal direction along main body  12 . In this embodiment, port  20  comprises a tubular member  22 . Preferably, at least a portion of the length of tubular member  22  is provided with external threads  23 . An end cap  24  having internal threads  25  is received over the external threads of tubular member  22 . External threads  23  and internal threads  25  are sized and aligned for threaded engagement in well-known fashion along mating surfaces, e.g., as shown in  FIGS. 5 and 6 . Those skilled in the art will appreciate that other known means of engaging the tubular member and end cap may be substituted. An opening  26  extends through end cap  24 , and communicates with the hollow interior of main body  12 . In a preferred embodiment, a valve member, such as a check-flow disk-type valve  27  ( FIGS. 5 ,  6 ), a Tuohy valve, or other conventional valve, is provided internally of end cap  24  in well-known fashion to establish a fluid-tight connection with main body  12 . 
     Port  30  extends at substantially a 90 degree angle from the major axis of main body  12 . In the embodiment shown, port  30  is equipped with a conventional 15 mm connector  32  for connection to a conventional mechanical ventilator (not shown). Although port  30  preferably extends at an angle of about 90 degrees from the major axis as stated, those skilled in the art will appreciate that other angles between about 10 degrees and 170 degrees may be substituted, as long as the position of port  30  does not functionally interfere with ports  20  and  40 , as described herein. Other conventional connectors, such as a Luer connector suitable for engagement with a mating connector of, e.g., a jet ventilator, may be substituted for the 15 mm ventilation connector  32  shown in the figures. 
     Port  40  is located opposite and functionally in-line with port  20  along the major axis of main body  12 . Although it is preferred that ports  20  and  40  are axially in-line with each other along the major axis of apparatus  10 , ports  20  and  40  need not necessarily be exactly axially in-line in all instances. However, it is preferred that they are at last substantially in-line (e.g., not axially offset by more than about 20 degrees). Port  40  is configured, e.g., as a connector for engaging the proximal end of a device, such as an airway exchange catheter  90 . As shown in  FIGS. 4-6  and as described herein, this connector may be constructed in a manner to rapidly connect, and disconnect, the airway exchange catheter  90  from airway management apparatus  10 . In the non-limiting embodiment shown and described, port  40  is configured such that the proximal end of the airway exchange catheter is connected to the port in a manner similar to that shown in the incorporated-by-reference &#39;386 patent. In this embodiment, port  40  comprises a radially compressible mechanism, such as the plurality of fingers  42  that extend in the axial direction from a generally cylindrical base portion  43 . Fingers  42  are separated by slots  44 , and are circumferentially aligned in manner to define a chamber for snugly receiving the proximal end of the catheter. An axially slidable collar  46  is positioned about fingers  42 . 
       FIG. 4  illustrates the airway management apparatus  10  as shown in  FIG. 3 , engaged with an airway exchange catheter  90 . Airway exchange catheter  90  preferably includes one or more side ports  95  along a distal end of the catheter. Side ports  95  permit the ventilation fluid (e.g., oxygen) to pass through the catheter to oxygenate the patient even when a wire guide  96  or like device extends through the catheter, as shown in the figure. Airway exchange catheters are well known in the art, and are described, for example, in the incorporated-by-reference &#39;386 patent. Further description of the airway exchange catheter is not necessary for an understanding of the present invention, as those skilled in the art are capable of selecting a suitable airway exchange catheter or like device for use herein, when applying the teachings of the present invention. 
     A small diameter guide device, such as wire guide  96 , extends through the apparatus. Although the small diameter apparatus is described and shown herein as a wire guide, those skilled in the art will appreciate that other medical devices having a diameter similar to, or slightly larger than, the diameter of a conventional wire guide may be inserted instead of, or in addition to, the wire guide (e.g., positioned over the wire guide). Non-limiting examples of such devices include small diameter catheters (e.g., about 0.035 to 0.07 inch [0.89 to 1.78 mm] diameter), obturators, and bougies. 
       FIGS. 5 and 6  illustrate longitudinal sectional views of airway management apparatus  10 , also showing the catheter  90  and wire guide  96 . In  FIG. 5 , the collar  46  is positioned over fingers  42 .  FIGS. 5A , and  5 B are enlarged views showing detail of the fingers and collar, respectively. In the arrangement of  FIG. 5 , the fingers  42  are compressed in a radially inward direction against catheter  90 , such that catheter  90  is locked into engagement with apparatus  10 . In  FIG. 6 , the collar  46  is disposed proximal to the position shown in  FIG. 5 . In this arrangement, the compression exerted upon catheter  90  by the fingers is relaxed, whereupon the catheter may be removed from airway management apparatus  10 . 
     As further shown in  FIGS. 4-6 , the proximal end  92  of catheter  90  is fully received in the chamber defined by fingers  42  and cylindrical base  43 . In the preferred embodiment shown, catheter proximal end  92  engages an O-ring seal  49  positioned at the proximal end of port  40 . O-ring seal  49  may be formed of conventional construction, such as nitrile rubber, a synthetic rubber copolymer. When catheter proximal end  92  is positioned against the O-ring seal, the catheter is pneumatically sealed in the chamber. 
     When the proximal end  92  of catheter  90  is initially inserted in the chamber, collar  46  is in a proximal position as shown in  FIG. 6 , and the distal ends of the fingers deflect in a radially outward direction. In one embodiment, each finger  42  may include a projection  48  ( FIG. 5A ) that extends inwardly into the chamber. The dimension between the opposing projections  48  of the flexible members is less than the outside diameter of the catheter  90 . As a result, when the catheter proximal end  92  is inserted in the chamber, the distal ends of the fingers are urged in a radially outward direction as shown in  FIG. 6 . 
     Circumferentially arranged fingers  42  may have a conically shaped outer cam surface  45  along their distal length. The inside surface  52  ( FIG. 5B ) of ring-like collar  46  engages respective cam surfaces  45  when the collar is moved toward the distal end of the fingers as shown. As a result, projections  48  are forced in a radially inward direction in a gripping fashion against the outside surface of catheter  90 . 
     As depicted in  FIG. 5 , collar  46  has been advanced to a fully distal position. Preferably, collar  46  includes a distal notched portion  47  that is sized and positioned to engage a cooperating retaining flange  54  of the respective fingers. When at the distal position, the inside surface of collar  46  fully engages the cam surfaces of the respective fingers, thereby forcing projections  48  against the outside surface of catheter  90 . In this position, the catheter  90  is in a “locked” position relative to port  40 . To unlock the catheter, collar  46  is slid in the proximal direction shown in  FIG. 6 , thereby disengaging the cam surface  45  of respective fingers  42 . Fingers  42  may include a recessed surface or notch  41  adjacent can surface  45 . This recessed surface limits the engagement of the collar with the fingers. As a result, the force necessary to move the collar to a proximal position and thereby “unlock” the port is minimized. Further discussion and explanation of this locking and rapid disconnect feature of port  40  is provided in the incorporated-by-reference &#39;386 patent. 
       FIG. 7  is a side view of an alternative embodiment of an airway management apparatus  80 . Airway management apparatus  80  has many features in common with apparatus  10 , which features are provided with common numbers with the embodiment of  FIGS. 1-6 . In the embodiment of  FIG. 7 , airway management apparatus  80  includes an additional port  82 . As illustrated, this port may be positioned opposite port  30  along the major axis of main body  12 . Port  82  is shown with a Luer connection  84  for engagement with a mating connector of a medical or diagnostic device, e.g., a jet ventilator (not shown). Those skilled in the art will appreciate that other ports and port configurations, and connectors, may be provided in place of, or in addition to, port  82 . Similarly, as stated above, other ports and port configurations may be provided in place of, or in addition to, port  30 . 
     One example of use of the airway management apparatus  10  will now be described. In this example, airway exchange apparatus  10  is utilized to oxygenate a patient during replacement of an endotracheal tube ( FIG. 8 ). Endotracheal tubes are well-known medical devices for providing ventilation to a patient. Endotracheal tube  150  includes a ventilator connector  152  at its proximal end. In this example, ventilator connector  152  is sized for connecting the endotracheal tube to a conventional ventilation apparatus  170  in well-known manner. A ventilation passageway  154  extends through the endotracheal tube for passage of a ventilating fluid through an open distal end  155  to ventilate the patient. Open distal end  155  is shown partially broken away to better illustrate the distal end of airway exchange catheter  90  that extends through the passageway of the endotracheal tube. Endotracheal tube  150  also includes an inflatable cuff  156  positioned in the vicinity of the distal end thereof to securely position and seal the distal end of the endotracheal tube in the trachea  200 . Cuff  156  is inflated in conventional fashion with air supplied through an inflation tube  158  attached to the external surface of endotracheal tube  150 . An inflatable pilot balloon  160  and a connector  162  may be provided at the proximal end of the inflation tube for use in inflating the cuff in well-known manner. 
     To prepare for endotracheal tube replacement, an airway exchange catheter  90  is engaged with port  40  of airway management apparatus  10 . Proximal end  92  of the catheter is received in the chamber defined by fingers  42  and cylindrical base  43  as described hereinabove. Collar  46  is thereafter advanced to the distal position ( FIG. 5 ) to securely engage catheter proximal end  92  with port  40  as described above. 
     The connection between the endotracheal tube  150  and ventilation apparatus  170  is interrupted by disconnecting the endotracheal tube  150  from the ventilation apparatus at ventilator connector  152 . The ventilation apparatus  170  is thereafter connected to ventilator connector  32  at port  30  of the airway management apparatus  10 , as shown in  FIG. 8 . The airway exchange catheter  90  is inserted through ventilator connector  152  and passageway  154  of the endotracheal tube  150 . The distal end  94  of catheter  90  extends beyond endotracheal tube distal end  155  and into the trachea  200  to supply oxygen to the patient. 
     Wire guide  96  (or other medical apparatus as described above) is introduced into apparatus  10  via port  20 . Typically, the wire guide is about twice as long as the airway exchange catheter, although these relative dimensions may be varied if desired. The wire guide is advanced through ports  20  and  40  along the major axis of airway management apparatus  10 , and thereafter through catheter  90 , such that the distal end of wire guide  96  extends beyond (i.e., distal to) the distal end of catheter  90  in the trachea, as shown in  FIG. 8 . The presence of the wire guide enables the operator to maintain access to the trachea, even if the catheter and endotracheal tube are removed, withdrawn, or otherwise dislodged from the trachea. 
     With a chronically placed endotracheal tube, it is not uncommon for the tissue of the patient&#39;s airway to become inflamed, and thereby encapsulate the endotracheal tube. When the endotracheal tube is removed, the inflamed tissue may hinder or prevent passage of air through the patient&#39;s airway, and may hinder access to the trachea. Thus, maintaining a wire guide (or a small diameter catheter, bougie, etc.), in the airway enables the medical professional to maintain access to the trachea, even after the endotracheal tube and/or airway exchange catheter have been withdrawn. 
     The endotracheal tube cuff is deflated, and the endotracheal tube is withdrawn from the trachea along the airway exchange catheter  90 . Generally, when the endotracheal tube has been fully withdrawn from the trachea, the proximal end of the endotracheal tube substantially reaches port  40 . At this stage, the patient is oxygenated by way of the ventilation fluid passing through one or more openings at the distal end of catheter  90 . The presence of the side ports  95  insures a route for the oxygen to pass through the catheter  90  to the trachea even if the wire guide or other small diameter device blocks, or substantially blocks, passage of oxygen out the distal end opening of the catheter. 
     At this time, the airway management apparatus  10  may be removed from catheter  90  by disconnecting proximal end  92  of the catheter from airway management apparatus  10  at port  40  ( FIGS. 5 ,  6 ), and withdrawing apparatus  10  over the wire guide. As stated above, and in the incorporated-by-reference &#39;386 patent, this disconnect step is facilitated due to the rapid disconnect features provided at port  40 . In the example described in the specification, the rapid disconnect features includes the fingers  42  and collar  46  shown in  FIGS. 5 ,  6 . Endotracheal tube  150  is removed from the trachea and airway of the patient over catheter  90 , while the catheter and wire guide remain in place in the trachea of the patient. Following removal of the endotracheal tube, airway management apparatus  10  may be reinserted over the wire guide, and re-connected to catheter proximal end  92  at port  40  to re-establish a flow of oxygen to the patient. 
     An endotracheal tube is then arranged for re-insertion into the trachea. The endotracheal tube may be a new tube, or alternatively, may be the same endotracheal tube  150  that had been removed and cleaned. Catheter proximal end  92  is once again disconnected from port  40  of the airway management apparatus as described above, and apparatus  10  is withdrawn over the proximal end of wire guide  96 . The endotracheal tube is then inserted over catheter proximal end  92  and wire guide  96 , and advanced into the trachea. The catheter is reconnected to port  40  in the manner described above, thereby resuming the supply of oxygen to the patient, through the side ports  95  of catheter  90 . 
     If difficulties are encountered during re-insertion of the endotracheal tube, the physician can remove the tube, re-establish oxygenation via catheter  90 , and when deemed appropriate, repeat the endotracheal tube insertion process. The rapid disconnect features of port  40  as described above facilitate such removal and re-insertion. Once insertion of the endotracheal tube has been completed, airway exchange catheter  90  and wire guide  96  are withdrawn from the lumen of the endotracheal tube. Ventilator apparatus  170  is disconnected from the ventilator connector at port  30 , and re-connected to ventilator connector  152  of the endotracheal tube. 
     Those skilled in the art will appreciate that not all steps described above need be performed in the exact order described in this example in all instances. Further, it may not be necessary to carry out each step described in the example in every instance, and those skilled in the art are capable of determining whether any modification of the described process is appropriate. However, it is believed that optimal results will be obtained in most instances when the tubular replacement process is carried out in the manner described herein. 
     Unlike the rapid disconnect feature described in the &#39;386 patent, the airway management apparatus  10  of the present invention is capable of receiving wire guide  96 , while at the same time being operably connected to the ventilation apparatus as described in the example, or to an alternative ventilation connector, such as a connector suitable for use with a jet-type ventilator. Thus, access to the trachea is maintained throughout the endotracheal tube replacement process. 
     It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting, and that it be understood that it is the following claims, including all equivalents, that are intended to define the spirit and scope of this invention.