Patent Publication Number: US-RE41345-E

Title: Valued fenestrated tracheotomy tube having outer and inner cannulae

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This is a continuation-in-part of U.S Ser. No. 09/398,110 filed Sep. 16, 1999 now abandoned and titled Valved Fenestrated Tracheotomy Tube Having Outer and Inner Cannulae. U.S. Ser. No. 09/398,110 is a continuation-in-part of U.S. Ser. No. 09/360,274 filed Jul. 26, 1999 now abandoned and titled Valved Fenestrated Tracheotomy Tube. U.S. Ser. No. 09/360,274 is a continuation of U.S. Ser. No. 08/996,282 filed Dec. 22, 1997 and titled Valved Fenestrated Tracheotomy Tube, now U.S. Pat. No. 5,957,978. U.S. Ser. No. 09/398,110 and U.S. Ser. No. 09/360,274 are both now abandoned. The disclosures of these prior applications are hereby incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     This invention relates to improvements in tracheotomy tubes. 
     BACKGROUND OF THE INVENTION 
     This invention is directed toward the problem of being unable to produce audible laryngeal voice, and thus, the inability to speak, that confronts individuals whose breathing is provided mechanically by a respirator which is connected to a cuffed tracheotomy tube inserted into the trachea of a wearer below the level of the vocal cords. The cuff on the tracheotomy tube is inflated, for example, with air, so that the cuff seals substantially fluid tight against the wall of the trachea. The purposes of the inflated cuff include: to protect against leakage of saliva and other secretions around the tracheotomy tube and into the lungs; and, to prevent the air being delivered under pressure from the respirator through the tracheotomy tube to the lungs and exhalation from the lungs from escaping around the tracheotomy tube and out through the mouth and nose of the wearer. In other words, the inflated cuff provides a closed mechanical respiratory system that completely bypasses the upper airway above the level of the tracheotomy tube, including the vocal cords. The side effects of this include the elimination of exhaled airflow upward through the vocal cords. Of course, this eliminates voice production and audible speech. 
     Currently, there are only two available options for individuals being mechanically ventilated via a cuffed tracheotomy tube to produce audible voice and speech with their own vocal cords. The first of these options is described in O. Hessler, M. D., K. Rehder, M. D., and S. W. Karveth, MC, U. S. A., “Tracheostomy Cannula for Speaking During Artificial Respiration,” Anesthesiology, vol. 25, no. 5, pp.719-721 (1964). There is no known commercially available device constructed as described in Hessler, et al. 
     The second option is a so-called “talking tracheotomy tube,” which is a conventional cuffed tracheotomy tube manufactured with an 8-10 French conduit extending along its length. The distal end of this conduit terminates above the level of the inflated cuff. The proximal end of this conduit is connected to a source of, for example, compressed air. Examples of such a device are manufactured by Sims Portex, Inc., and Bivona Surgical Inc. The wearer of such a device is able to stop and start the flow of compressed air to the distal end of this conduit, thereby enabling the stopping and starting of the flow of air upward through his or her vocal cords, enabling the wearer to produce speech. This speech airflow is completely independent of the respiratory airflow through the tracheotomy tube. Such talking tracheotomy tubes have been available for several years, but are not in widespread use, perhaps owing to numerous mechanical limitations. 
     A ventilator-dependent patient breathing through cuffed tracheotomy tube is unable to produce audible voice with his or her vocal cords because the cuff of the tracheotomy tube he or she wears prevents exhalations from going around the lower end of the tube and upward through the vocal cords. This situation continues until the wearer&#39;s condition improves sufficiently that the cuff on the tracheotomy tube can be deflated so that exhaled air can pass around the tracheotomy tube and up through the wearer&#39;s vocal cords, mouth and nose, permitting audible vocal cord vibrations for speech. 
     The invention alleviates this situation. When coupled to a respirator with its cuff inflated, a valved, cuffed tracheotomy tube system according to the invention directs air on the inhalation cycle of the respirator to the lungs. Exhalations are directed by the valved, cuffed tracheotomy tube system according to the invention to the upper airway, permitting vocal cord vibration and audible laryngeal speech. 
     DISCLOSURE OF THE INVENTION 
     According to one aspect of the invention, an outer cannula has a first port for orienting outside the neck of a wearer, a second port for orienting within the trachea of the wearer, a first passageway coupling the first port to the second port to permit the flow of gases from the first port to the second during inhalation by the wearer and from the second port during exhalation by the wearer, and a third port between the first and second ports. An inner cannula is configured for insertion into the first passageway via the first port when the wearer desires to be able to exhale through his or her pharynx. The inner cannula includes a fourth port for orienting adjacent the first port, a fifth port for orienting adjacent the second port and a second passageway coupling the fourth port to the fifth port to permit the flow of gases from the fourth port to the fifth during inhalation by the wearer and from the fifth port during exhalation by the wearer . A valve control flow through the third port. The valve assumes a first orientation to permit flow from the first  fourth port to the second  fifth port when the first  fourth port is at a higher pressure than the second  fifth port, and a second orientation to permit  prevent flow from the second  fourth port through the third port  when the second  fifth port is at a higher pressure than the first  fourth port. 
     Illustratively according to the invention, the valve includes a movable member and a seat. The movable member moves away from the seat to permit flow from the fourth port to the fifth port when the fourth port is at a higher pressure than the fifth port, and seats against the seat to impede flow from the fifth port  through the fourth port and promote flow from the fifth port  through the third port when the fourth port is at a lower pressure than the fifth port. 
     Illustratively according to the invention, the seat is provided in the second passageway. 
     Alternatively illustratively according to the invention, the seat is provided in the first passageway. 
     Additionally according to the invention, the valve includes a movable member and a seat. The movable member moves toward the seat to impede flow from the fourth port through the third port when the fourth port is at a higher pressure than the fifth port, and moves away from the seat to permit flow from the fifth port  through the third port when the fourth port is at a lower pressure than the fifth port. 
     Further illustratively according to the invention, the outer cannula includes an inflatable cuff between the second and third ports and a third passageway for introducing an inflating fluid into the cuff in situ in the trachea of the wearer to impede the flow of fluids between the cuff and the trachea when the cuff is inflated. 
     Additionally illustratively according to the invention, the outer cannula includes a flexible member for covering the third port. 
     Illustratively according to the invention, the flexible member and the outer cannula include complementary first and second attachment members, respectively, for attaching the flexible member to the outer cannula. The second attachment member provides an attachment point located within the third port for attachment of the first attachment member to the second attachment member at the attachment point. 
     Alternatively illustratively according to the invention, the flexible member comprises a flexible membrane having a slit in it. 
     Alternatively illustratively according to the invention, the flexible member comprises a flap for covering the third port. 
     According to another aspect of the invention, a tracheotomy cannula has a first port for orienting outside the neck of a wearer, a second port for orienting within the trachea of the wearer and a first passageway coupling the first port to the second port to permit the flow of gases from the first port to the second during inhalation by the wearer and from the second port during exhalation by the wearer. The cannula includes a portion formed from a thermoplastic material having a first, generally curved orientation  configuration when said portion is maintained substantially below body temperature and a second, somewhat inverted L-shaped configuration when said portion is warmed substantially to body temperature. 
     According to another aspect of the invention, a tracheotomy cannula has a first port for orienting outside the neck of a wearer, a second port for orienting within the trachea of the wearer and a first passageway between the first port and the second port to permit the flow of gases from the first port to the second during inhalation by the wearer and from the second port during exhalation by the wearer. The cannula includes a portion formed from a relatively more flexible material. A stylet is formed from a relatively less flexible material. The stylet has a generally curved orientation  configuration. The tracheotomy cannula has a somewhat inverted L-shaped configuration when the stylet is not inserted into the first passageway and a generally curved orientation  configuration when the stylet is inserted into the first passageway. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention may best be understood by referring to the following detailed description and accompanying drawings which illustrate the invention. In the drawings: 
         FIG. 1  illustrates a partly fragmentary lateral section through the trachea, tracheostoma and lower pharynx of a wearer fitted with a device according to the present invention; 
         FIG. 2  illustrates an exploded perspective view of the device illustrated in  FIG. 1 ; 
         FIG. 3  illustrates a somewhat enlarged, partly fragmentary lateral section through the trachea, tracheostoma and lower pharynx of a wearer fitted with a device according to the present invention, with the device illustrated in the position it assumes during exhalation by the wearer; 
         FIG. 4  illustrates a somewhat enlarged, partly fragmentary lateral section through the trachea, tracheostoma and lower pharynx of a wearer fitted with the device of  FIG. 3  illustrated in another position; 
         FIG. 5  illustrates a fragmentary sectional view through the embodiment illustrated in  FIGS. 1-4 , taken generally along section lines  5 — 5  of  FIG. 4 ; 
         FIG. 6  illustrates a partly fragmentary lateral section through the trachea, tracheostoma and lower pharynx of a wearer fitted with another device according to the present invention in the position it assumes during exhalationinhalation by the wearer; 
         FIG. 7  illustrates a partly fragmentary lateral section through the trachea, tracheostoma and lower pharynx of a wearer fitted with the device illustrated in  FIG. 6 , with the device illustrated in another position it assumes; 
         FIG. 8  illustrates a partly fragmentary lateral section through the trachea, tracheostoma and lower pharynx of a wearer fitted with another device according to the present invention, with the device illustrated in its orientation during insertion into the trachea of the wearer; 
         FIG. 9  illustrates a partly fragmentary lateral section through the trachea, tracheostoma and lower pharynx of a wearer fitted with the device illustrated in  FIG. 8 , with the device illustrated in the orientation it assumes once it has been inserted into the trachea of the wearer and warmed substantially to body temperature; 
         FIG. 10  illustrates a partly fragmentary lateral section through the trachea, tracheostoma and lower pharynx of a wearer fitted with another device constructed according to the invention, with the device illustrated in a use orientation; and, 
         FIG. 11  illustrates a partly fragmentary lateral section through the trachea, tracheostoma and lower pharynx of a wearer fitted with the device illustrated in  FIG. 10 , with the device illustrated in an insertion orientation. 
     
    
    
     DETAILED DESCRIPTIONS OF ILLUSTRATIVE EMBODIMENTS 
     Referring now to  FIGS. 1-5 , a speaking tracheotomy tube system  10  includes an outer cannula  12  for insertion into a tracheostoma  14 . Outer cannula  12  includes an inflatable cuff  16 . Cuff  16  lies in the trachea  18  of the wearer  20  below the passageway  22  upward into the pharynx  24  of the wearer  20 . Outer cannula  12  also includes a first port  21  which resides outside the neck of the wearer  20  during use and a second port  23  which resides inside the neck of the wearer  20  below cuff  16  during use. The cuff  16  is inflatable through a line  26  (illustrated only in  FIG. 1 , for the purpose of clarity) once the outer cannula  12  is in place in the trachea  18  to prevent the passage of secretions  27  from the upper respiratory tract, including pharynx  24 , downward into the lungs of the wearer  20 . Such secretions inevitably pool  27  above the cuff  16  when the cuff  16  is inflated in place. To evacuate such pooling secretions  27 , a tube  29  extends in an indentation  31  provided therefor down the outer sidewall of outer cannula  12 . Tube  29  terminates at an open end  33  just above the level of the cuff  16 . The pooled secretions  27  are evacuated by the application of a vacuum  37  (illustrated only in  FIG. 2 , for the purpose of clarity) to the outer end  35  of tube  29 . 
     The outer cannula  12  includes a pivotally mounted attachment plate  30  adjacent its proximal end  32  to facilitate attachment, for example, by a strap or belt around the neck of the wearer  20 . The outer cannula  12  also includes a fenestration  34  which permits the wearer  20  to speak by forcing exhaled gases upward through the fenestration  34  and into the pharynx  24 . Speech may then be articulated in accordance with known principles. Although only one such fenestration  34  is illustrated, it should be understood that any number of fenestrations  34  may be provided in the outer cannula  12  for this purpose. The fenestration  34  is covered by a flexible sheet  36  of, for example, a suitable elastomer, which contains a slit  38  for the passage of exhaled gases upward through the pharynx  24 . The flexible sheet  36  is provided to prevent the growth of so-called granulation tissue from the trachea  18  into the outer cannula  12  in accordance with known principles. While this covering  36  for the fenestration  34  is the only one illustrated in the drawings, numerous techniques for covering the fenestration  34  are known. See, for example, U.S. Ser. No. 09/360,274 and U.S. Ser. No. 08/996,282. 
     The speaking tracheotomy tube system  10  also includes an inner cannula  40  which is insertable through the lumen  42  of the outer cannula  12 . Inner cannula  40  includes a port  41  at an end thereof which lies adjacent port  21  when inner cannula  40  is inserted into its use orientation within outer cannula  12  and a port  43  which lies adjacent port  23  when inner cannula  40  is inserted into its use orientation within outer cannula  12 . Inner cannula  40  also includes a connector  60  portion for connecting the inner cannula  40  to a ventilator  62 , illustrated in block form only in  FIG. 2 , for the purpose of clarity, to inflate the wearer&#39;s lungs. 
     The inner cannula  40  also includes an opening  64  and a cooperating flap  66  adjacent the fenestration  34  of the outer cannula  12 . On pressurization of the inner cannula  40 , the flap  66  assumes the position illustrated in  FIG. 4  in which air from the ventilator  62  passes freely down the lumen  68  of the inner cannula  40  into the lungs of the wearer  20 . The escape of air upward when the flap  66  is in this position is prevented by the cuff  16  and by the orientation of flap  66  illustrated in  FIG. 4  in which flap  66  seals opening  64 . However, the inner cannula  40 , including its flap  66 , is constructed so that, on depressurization of the ventilator  62 , the flap  66  moves to the position illustrated in  FIG. 3 , directing the exhaled air upward out of the inner cannula  40 , through the fenestration  34  with its slitted flexible sheet  36 , and upward into the pharynx  24  of the wearer  20  for use in producing speech. A seat  70  for the flap  66  is provided inside inner cannula  40  when the flap  66  is in its position illustrated in  FIG. 3  to reduce the likelihood of the escape of exhaled gases back through the ventilator connector  60 . 
     The flap  66  can have a plan view somewhat the shape of a ping pong paddle, with the sealing portion of the flap  66  corresponding to the hitting portion of the paddle and the hinge portion of the flap  66  corresponding to the handle of the paddle. In order to reduce the likelihood of eversion of the flap  66  through its seat  70 , the flap  66  can be constructed from a stiffer material, such as, for example, a stiffer silicone, or may be molded with a reinforcement to stiffen it, such as, for example, a molded-in X-shaped wire reinforcement or an X-shaped boss on one or the other or both of its major surfaces, or the like. The hinge, or handle of the ping pong paddle, can, for example, be located in a notch provided therefor in the wall of the cannula  40  where it is attached by an appropriate adhesive, or can be inserted into an opening provided therefor in the wall of the cannula  40  where it is attached by an appropriate adhesive, or can be attached to the inner surface of the wall of the cannula  40  by an appropriate adhesive. 
     Typically, ventilators  62  are provided with mechanisms to measure exhaled gas volume and alarms to indicate when recovered gas volume during exhalation is much less than output gas volume during the pressurization phase of the ventilator  62 s&#39; operation. These mechanisms, or at least the alarms of these mechanisms, may have to be disconnected to prevent the alarms from sounding during use of the inner cannula  40  by the wearer  20  during speaking sessions. 
     The tracheotomy tube system  10  can be quickly converted into a conventional tracheotomy tube by pushing the formed proximal end  80  of a somewhat blade-shaped lock  82  inward. See FIG.  4 . Lock  82  is slidable in a channel  84  provided therefor within lumen  68 . See FIG.  5 . The distal end  86  of lock  82  lies adjacent the inside surface of flap  66 . When lock  82  is slid distally in channel  84 , its distal end  86  interferes with the opening of flap  66  to its orientation illustrated in FIG.  3 . See FIG.  4 . This prevents the escape of air upward through opening  64 , but provides relatively unrestricted access through lumen  68  to the wearer  20 &#39;s trachea  18 . Alternatively, the tracheotomy tube system  10  can be converted into a conventional tracheotomy tube by removing inner cannula  40  and inserting a non-fenestrated, non-valved conventional inner cannula (not shown) into lumen  42 . To provide positive positioning of blade  82  in one or the other of its non-speaking ( FIG. 4 ) or speaking ( FIG. 3 ) orientations, blade  82  is provided with two holes  88 ,  90  adjacent its proximal end  80 . A nub  92  is provided on the inside wall of cannula  40  adjacent its proximal end. When blade  82  is in its speaking orientation (FIG.  3 ), nub  92  engages in hole  88 . When blade  82  is in its non-speaking orientation (FIG.  4 ), nub  92  engages in hole  90 . 
     In another embodiment of the invention illustrated in  FIGS. 6-7 , a speaking tracheotomy tube system  110  includes an outer cannula  112  for insertion into a tracheostoma  114 . Outer cannula  112  includes an inflatable cuff  116 . Cuff  116  lies in the trachea  118  of the wearer  120  below the passageway  122  upward into the pharynx  124  of the wearer  120 . Outer cannula  112  also includes a first port  121  which resides outside the neck of the wearer  120  during use and a second port  123  which resides inside the neck of the wearer  120  below cuff  116  during use. The cuff  116  is inflatable through a line (not shown) once the outer cannula  112  is in place in the trachea  118  to prevent the passage of secretions from the upper respiratory tract, including pharynx  124 , downward into the lungs of the wearer  120 . A tube  129  extends in an indentation  131  provided therefor down the outer sidewall of outer cannula  112 . Tube  129  terminates at an open end  133  just above the level of the cuff  116 . Pooled secretions are evacuated by the application of a vacuum to the outer end (not shown) of tube  129 . 
     The outer cannula  112  includes a fenestration  134  which permits the wearer  120  to speak by forcing exhaled gases upward through the fenestration  134  and into the pharynx  124 . Speech may then be articulated in accordance with known principles. The fenestration  134  is covered by a flexible flap  136  of, for example, a suitable elastomer, which moves upward to the position illustrated in broken lines in  FIG. 7  for the passage of exhaled gases upward through the pharynx  124 . Again, the flap  136  is provided to prevent the growth of granulation tissue from the trachea  118  into the outer cannula  112 . See, for example, U.S. Ser. No. 09/360,274 and U.S. Ser. No. 08/996,282. 
     The speaking tracheotomy tube system  110  also includes an inner cannula  140  which is insertable through the lumen  142  of the outer cannula  112 . Inner cannula  140  includes a port  141  at an end thereof which lies adjacent port  121  when inner cannula  140  is inserted into its use orientation within outer cannula  112  and a port  143  which lies adjacent port  123  when inner cannula  140  is inserted into outer cannula  112 . Inner cannula  140  also includes a connector  160  for connecting the inner cannula  140  to a ventilator  162 , illustrated in block form in  FIG. 6  only, for the purpose of clarity, to inflate the wearer&#39;s lungs. 
     The inner cannula  140  also includes an opening  164  and a cooperating flap  166  adjacent the fenestration  134  of the outer cannula  112 . On pressurization of the inner cannula  140 , the flap  166  swings upward to the position illustrated in  FIG. 6  in which air from the ventilator  162  passes freely through the lumens  142 ,  168  of the outer and inner cannulae  112 ,  140 , respectively, into the lungs of the wearer  120 . The escape of air upward when the flap  166  is in this position is prevented by the cuff  116  and by the orientation of flap  166  illustrated in  FIG. 6  in which flap  166  seals against the seat  172 . However, the inner cannula  140 , including its flap  166 , is constructed so that, on depressurization of the ventilator  162 , the flap  166  swings downward to the position illustrated in  FIG. 7 , directing the exhaled air upward out of the inner cannula  140 , through the fenestration  134  with its flexible flap  136 , and upward into the pharynx  124  of the wearer  120  for use in producing speech. Seats  170 ,  172  are provided for the flap  166  at the distal end of the inner cannula  140  and inside fenestration  134 , respectively, for when the flap  166  is in its positions illustrated in  FIGS. 7 and 6 , respectively. Seat  170  reduces the likelihood of the escape of exhaled gases back through the ventilator connector  160 . Orientation markers (not shown) may be provided on the proximal end  154  of the outer cannula  112  and the proximal end  146  of the inner cannula  140  to permit the proper orientation of flap  166  with respect to seat  170 . 
     Again, the flap  166  has somewhat the shape of a ping pong paddle in elevation, with the sealing portion of the flap  166  corresponding to the hitting portion of the paddle and the hinge portion of the flap  166  corresponding to the handle of the paddle. In order to reduce the likelihood of eversion of the flap  166  through its opening  164 , the flap  166  can be constructed from a stiffer material, such as, for example, a stiffer silicone, or may be molded with a reinforcement to stiffen it, such as, for example, a molded-in X-shaped wire reinforcement or an X-shaped boss on one or the other or both of its major surfaces, or the like. Again, the hinge, or handle of the ping pong paddle, can be located in a notch provided therefor in the wall of the cannula  40  where it is attached by an appropriate adhesive, or inserted into an opening provided therefor in the wall of the cannula  140  where it is attached by an appropriate adhesive, or attached to the inner surface of the wall of the cannula  140  by an appropriate adhesive. 
     The tracheotomy tube system  110  can be quickly converted into a conventional tracheotomy tube by pushing the formed proximal end  180  of a somewhat blade-shaped lock  182  inward. See FIG.  6 . Lock  182  is slidable in a channel  184  provided therefor within lumen  168 . The distal end  186  of lock  182  lies adjacent the front surface of flap  166 . When lock  182  is slid distally in channel  184 , its distal end  186  interferes with the opening of flap  166  to its orientation illustrated in FIG.  7 . See FIG.  6 . This prevents the escape of air upward through opening  164 , but provides relatively unrestricted access through lumen  168  to the wearer  120 &#39;s trachea  118 . Alternatively, the tracheotomy tube system  110  can be converted into a conventional tracheotomy tube by removing inner cannula  140  and inserting a non-fenestrated, non-valved conventional inner cannula (not shown) into lumen  142 . To provide positive positioning of blade  182  in one or the other of its non-speaking ( FIG. 6 ) or speaking ( FIG. 7 ) orientations, blade  182  is provided with two holes  188 ,  190  adjacent its proximal end  180 . A nub  192  is provided on the inside wall of cannula  140  adjacent its proximal end. When blade  182  is in its speaking orientation (FIG.  7 ), nub  192  engages in hole  188 . When blade  182  is in its non-speaking orientation (FIG.  6 ), nub  192  engages in hole  190 . 
     The embodiments of  FIGS. 1-5  and  5 - 6    6 -   7   illustrate two different configurations of outer cannulae. While the configuration illustrated in  FIGS. 1-5  is easier to insert into, and remove from, the trachea of a wearer, the configuration illustrated in  FIGS. 6-7  has a more natural shape. That is, the configuration of the trachea and tracheostoma of a wearer is configured rather more like the inverted L configuration of outer cannula  112  and inner cannula  140   and rather less like the curved configuration of outer cannula  12  and inner cannula  40  . According to another aspect of the invention, an outer cannula  212  is provided which is constructed from a thermoplastic resin which has the somewhat more curved configuration of outer cannula  12  when outer cannula  212  is at temperatures somewhat lower than body temperature, illustrated in  FIG. 8 , but which reverts to the somewhat more inverted L configuration of outer cannula  112  when it is inserted into the trachea of a wearer. See FIG.  9 . This characteristic facilitates insertion of the outer cannula  212  into the trachea  218  of a wearer  220 , while providing the somewhat more natural inverted L configuration once the outer cannula  212  is inserted. Of course, removal is rendered somewhat more difficult, but such outer cannulae  212  typically reside for extended times in their wearers  220 . 
     In another embodiment constructed according to the invention and illustrated in  FIGS. 10-11 , a relatively pliable, for example, relatively low-durometer silicone, tracheotomy tube  250  of a somewhat L-shaped configuration is provided with a stylet  252  having a somewhat bullet-shaped remote end  254  for ease of insertion through a tracheostoma  256  into the trachea  258  of a wearer  260 . The proximal end  266  of the tracheotomy tube  250  is provided with some means such as, for example, a flange  268 , to permit the healthcare worker to hold the proximal end  266  of the tracheotomy tube  250  so that the stylet  252  can be inserted into the open proximal end  266  of the tube  250  and pushed the full length into the tracheotomy tube  250  to cause deflection of the relatively pliable tracheotomy tube  250  from its somewhat L-shaped configuration illustrated in  FIG. 10  into a somewhat more curved configuration illustrated in FIG.  11 . This configuration facilitates insertion of the tracheotomy tube  250  through the tracheostoma  256  and into the trachea  258  of the wearer  260 . Once the tracheotomy tube  250  is in place in the trachea  258  of the wearer  260 , the stylet  252  is removed, at which time the tracheotomy tube  250  returns from its somewhat more curved configuration illustrated in  FIG. 11  to its somewhat more L-shaped configuration illustrated in FIG.  10 . 
     To remove the tracheotomy tube  250  from the trachea  258  of the wearer  260 , the stylet  252  can be reinserted into the tracheotomy tube  250  to return it to its somewhat more curved configuration illustrated in  FIG. 11  prior to removing it from the trachea  258  of the wearer  260 . If this is done, the tracheotomy tube  250  comes out relatively easily. Alternatively, the tracheotomy tube  250  can be removed while still in its somewhat more L-shaped configuration. Although this requires somewhat more force than if the stylet  252  were used to render the tracheotomy tube  250  somewhat more curved in configuration, the tracheotomy tube  250  still can be removed without excessive effort or damage to the trachea  258  or tracheostoma  256  of the wearer  260 . The tracheotomy tube  250  is otherwise configured similarly to tracheotomy tube  112 ,  140  illustrated in  FIGS. 6-7 . 
     While many details of the embodiments illustrated in  FIGS. 1-7  are eliminated from the illustrations of  FIGS. 8-11  for the purpose of clarity, it is to be understood that practical embodiments of the invention illustrated in  FIGS. 8-11  can be provided with, for example, secretion evacuation tubes like tubes  29 ,  129  illustrated in  FIGS. 1-7 .