Valued fenestrated tracheotomy tube having outer and inner cannulae

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'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'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 firstfourth port to the secondfifth port when the firstfourth port is at a higher pressure than the secondfifth port, and a second orientation to permitprevent flow from the secondfourth port through the third port when the secondfifth port is at a higher pressure than the firstfourth 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 orientationconfiguration 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 orientationconfiguration. The tracheotomy cannula has a somewhat inverted L-shaped configuration when the stylet is not inserted into the first passageway and a generally curved orientationconfiguration 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:

<figref idref="DRAWINGS">FIG. 1</figref> 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;

<figref idref="DRAWINGS">FIG. 2</figref> illustrates an exploded perspective view of the device illustrated in <figref idref="DRAWINGS">FIG. 1</figref>;

<figref idref="DRAWINGS">FIG. 3</figref> 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;

<figref idref="DRAWINGS">FIG. 4</figref> illustrates a somewhat enlarged, partly fragmentary lateral section through the trachea, tracheostoma and lower pharynx of a wearer fitted with the device of <figref idref="DRAWINGS">FIG. 3</figref> illustrated in another position;

<figref idref="DRAWINGS">FIG. 5</figref> illustrates a fragmentary sectional view through the embodiment illustrated in <figref idref="DRAWINGS">FIGS. 1-4</figref>, taken generally along section lines <b>5</b>—<b>5</b> of <figref idref="DRAWINGS">FIG. 4</figref>;

<figref idref="DRAWINGS">FIG. 6</figref> 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;

<figref idref="DRAWINGS">FIG. 7</figref> illustrates a partly fragmentary lateral section through the trachea, tracheostoma and lower pharynx of a wearer fitted with the device illustrated in <figref idref="DRAWINGS">FIG. 6</figref>, with the device illustrated in another position it assumes;

<figref idref="DRAWINGS">FIG. 8</figref> 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;

<figref idref="DRAWINGS">FIG. 9</figref> illustrates a partly fragmentary lateral section through the trachea, tracheostoma and lower pharynx of a wearer fitted with the device illustrated in <figref idref="DRAWINGS">FIG. 8</figref>, 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;

<figref idref="DRAWINGS">FIG. 10</figref> 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,

<figref idref="DRAWINGS">FIG. 11</figref> illustrates a partly fragmentary lateral section through the trachea, tracheostoma and lower pharynx of a wearer fitted with the device illustrated in <figref idref="DRAWINGS">FIG. 10</figref>, with the device illustrated in an insertion orientation.

DETAILED DESCRIPTIONS OF ILLUSTRATIVE EMBODIMENTS

Referring now to <figref idref="DRAWINGS">FIGS. 1-5</figref>, a speaking tracheotomy tube system <b>10</b> includes an outer cannula <b>12</b> for insertion into a tracheostoma <b>14</b>. Outer cannula <b>12</b> includes an inflatable cuff <b>16</b>. Cuff <b>16</b> lies in the trachea <b>18</b> of the wearer <b>20</b> below the passageway <b>22</b> upward into the pharynx <b>24</b> of the wearer <b>20</b>. Outer cannula <b>12</b> also includes a first port <b>21</b> which resides outside the neck of the wearer <b>20</b> during use and a second port <b>23</b> which resides inside the neck of the wearer <b>20</b> below cuff <b>16</b> during use. The cuff <b>16</b> is inflatable through a line <b>26</b> (illustrated only in <figref idref="DRAWINGS">FIG. 1</figref>, for the purpose of clarity) once the outer cannula <b>12</b> is in place in the trachea <b>18</b> to prevent the passage of secretions <b>27</b> from the upper respiratory tract, including pharynx <b>24</b>, downward into the lungs of the wearer <b>20</b>. Such secretions inevitably pool <b>27</b> above the cuff <b>16</b> when the cuff <b>16</b> is inflated in place. To evacuate such pooling secretions <b>27</b>, a tube <b>29</b> extends in an indentation <b>31</b> provided therefor down the outer sidewall of outer cannula <b>12</b>. Tube <b>29</b> terminates at an open end <b>33</b> just above the level of the cuff <b>16</b>. The pooled secretions <b>27</b> are evacuated by the application of a vacuum <b>37</b> (illustrated only in <figref idref="DRAWINGS">FIG. 2</figref>, for the purpose of clarity) to the outer end <b>35</b> of tube <b>29</b>.

The outer cannula <b>12</b> includes a pivotally mounted attachment plate <b>30</b> adjacent its proximal end <b>32</b> to facilitate attachment, for example, by a strap or belt around the neck of the wearer <b>20</b>. The outer cannula <b>12</b> also includes a fenestration <b>34</b> which permits the wearer <b>20</b> to speak by forcing exhaled gases upward through the fenestration <b>34</b> and into the pharynx <b>24</b>. Speech may then be articulated in accordance with known principles. Although only one such fenestration <b>34</b> is illustrated, it should be understood that any number of fenestrations <b>34</b> may be provided in the outer cannula <b>12</b> for this purpose. The fenestration <b>34</b> is covered by a flexible sheet <b>36</b> of, for example, a suitable elastomer, which contains a slit <b>38</b> for the passage of exhaled gases upward through the pharynx <b>24</b>. The flexible sheet <b>36</b> is provided to prevent the growth of so-called granulation tissue from the trachea <b>18</b> into the outer cannula <b>12</b> in accordance with known principles. While this covering <b>36</b> for the fenestration <b>34</b> is the only one illustrated in the drawings, numerous techniques for covering the fenestration <b>34</b> 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 <b>10</b> also includes an inner cannula <b>40</b> which is insertable through the lumen <b>42</b> of the outer cannula <b>12</b>. Inner cannula <b>40</b> includes a port <b>41</b> at an end thereof which lies adjacent port <b>21</b> when inner cannula <b>40</b> is inserted into its use orientation within outer cannula <b>12</b> and a port <b>43</b> which lies adjacent port <b>23</b> when inner cannula <b>40</b> is inserted into its use orientation within outer cannula <b>12</b>. Inner cannula <b>40</b> also includes a connector <b>60</b> portion for connecting the inner cannula <b>40</b> to a ventilator <b>62</b>, illustrated in block form only in <figref idref="DRAWINGS">FIG. 2</figref>, for the purpose of clarity, to inflate the wearer's lungs.

The inner cannula <b>40</b> also includes an opening <b>64</b> and a cooperating flap <b>66</b> adjacent the fenestration <b>34</b> of the outer cannula <b>12</b>. On pressurization of the inner cannula <b>40</b>, the flap <b>66</b> assumes the position illustrated in <figref idref="DRAWINGS">FIG. 4</figref> in which air from the ventilator <b>62</b> passes freely down the lumen <b>68</b> of the inner cannula <b>40</b> into the lungs of the wearer <b>20</b>. The escape of air upward when the flap <b>66</b> is in this position is prevented by the cuff <b>16</b> and by the orientation of flap <b>66</b> illustrated in <figref idref="DRAWINGS">FIG. 4</figref> in which flap <b>66</b> seals opening <b>64</b>. However, the inner cannula <b>40</b>, including its flap <b>66</b>, is constructed so that, on depressurization of the ventilator <b>62</b>, the flap <b>66</b> moves to the position illustrated in <figref idref="DRAWINGS">FIG. 3</figref>, directing the exhaled air upward out of the inner cannula <b>40</b>, through the fenestration <b>34</b> with its slitted flexible sheet <b>36</b>, and upward into the pharynx <b>24</b> of the wearer <b>20</b> for use in producing speech. A seat <b>70</b> for the flap <b>66</b> is provided inside inner cannula <b>40</b> when the flap <b>66</b> is in its position illustrated in <figref idref="DRAWINGS">FIG. 3</figref> to reduce the likelihood of the escape of exhaled gases back through the ventilator connector <b>60</b>.

The flap <b>66</b> can have a plan view somewhat the shape of a ping pong paddle, with the sealing portion of the flap <b>66</b> corresponding to the hitting portion of the paddle and the hinge portion of the flap <b>66</b> corresponding to the handle of the paddle. In order to reduce the likelihood of eversion of the flap <b>66</b> through its seat <b>70</b>, the flap <b>66</b> 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 <b>40</b> where it is attached by an appropriate adhesive, or can be inserted into an opening provided therefor in the wall of the cannula <b>40</b> where it is attached by an appropriate adhesive, or can be attached to the inner surface of the wall of the cannula <b>40</b> by an appropriate adhesive.

Typically, ventilators <b>62</b> 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 <b>62</b>s' 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 <b>40</b> by the wearer <b>20</b> during speaking sessions.

The tracheotomy tube system <b>10</b> can be quickly converted into a conventional tracheotomy tube by pushing the formed proximal end <b>80</b> of a somewhat blade-shaped lock <b>82</b> inward. See FIG. <b>4</b>. Lock <b>82</b> is slidable in a channel <b>84</b> provided therefor within lumen <b>68</b>. See FIG. <b>5</b>. The distal end <b>86</b> of lock <b>82</b> lies adjacent the inside surface of flap <b>66</b>. When lock <b>82</b> is slid distally in channel <b>84</b>, its distal end <b>86</b> interferes with the opening of flap <b>66</b> to its orientation illustrated in FIG. <b>3</b>. See FIG. <b>4</b>. This prevents the escape of air upward through opening <b>64</b>, but provides relatively unrestricted access through lumen <b>68</b> to the wearer <b>20</b>'s trachea <b>18</b>. Alternatively, the tracheotomy tube system <b>10</b> can be converted into a conventional tracheotomy tube by removing inner cannula <b>40</b> and inserting a non-fenestrated, non-valved conventional inner cannula (not shown) into lumen <b>42</b>. To provide positive positioning of blade <b>82</b> in one or the other of its non-speaking (<figref idref="DRAWINGS">FIG. 4</figref>) or speaking (<figref idref="DRAWINGS">FIG. 3</figref>) orientations, blade <b>82</b> is provided with two holes <b>88</b>, <b>90</b> adjacent its proximal end <b>80</b>. A nub <b>92</b> is provided on the inside wall of cannula <b>40</b> adjacent its proximal end. When blade <b>82</b> is in its speaking orientation (FIG. <b>3</b>), nub <b>92</b> engages in hole <b>88</b>. When blade <b>82</b> is in its non-speaking orientation (FIG. <b>4</b>), nub <b>92</b> engages in hole <b>90</b>.

In another embodiment of the invention illustrated in <figref idref="DRAWINGS">FIGS. 6-7</figref>, a speaking tracheotomy tube system <b>110</b> includes an outer cannula <b>112</b> for insertion into a tracheostoma <b>114</b>. Outer cannula <b>112</b> includes an inflatable cuff <b>116</b>. Cuff <b>116</b> lies in the trachea <b>118</b> of the wearer <b>120</b> below the passageway <b>122</b> upward into the pharynx <b>124</b> of the wearer <b>120</b>. Outer cannula <b>112</b> also includes a first port <b>121</b> which resides outside the neck of the wearer <b>120</b> during use and a second port <b>123</b> which resides inside the neck of the wearer <b>120</b> below cuff <b>116</b> during use. The cuff <b>116</b> is inflatable through a line (not shown) once the outer cannula <b>112</b> is in place in the trachea <b>118</b> to prevent the passage of secretions from the upper respiratory tract, including pharynx <b>124</b>, downward into the lungs of the wearer <b>120</b>. A tube <b>129</b> extends in an indentation <b>131</b> provided therefor down the outer sidewall of outer cannula <b>112</b>. Tube <b>129</b> terminates at an open end <b>133</b> just above the level of the cuff <b>116</b>. Pooled secretions are evacuated by the application of a vacuum to the outer end (not shown) of tube <b>129</b>.

The outer cannula <b>112</b> includes a fenestration <b>134</b> which permits the wearer <b>120</b> to speak by forcing exhaled gases upward through the fenestration <b>134</b> and into the pharynx <b>124</b>. Speech may then be articulated in accordance with known principles. The fenestration <b>134</b> is covered by a flexible flap <b>136</b> of, for example, a suitable elastomer, which moves upward to the position illustrated in broken lines in <figref idref="DRAWINGS">FIG. 7</figref> for the passage of exhaled gases upward through the pharynx <b>124</b>. Again, the flap <b>136</b> is provided to prevent the growth of granulation tissue from the trachea <b>118</b> into the outer cannula <b>112</b>. See, for example, U.S. Ser. No. 09/360,274 and U.S. Ser. No. 08/996,282.

The speaking tracheotomy tube system <b>110</b> also includes an inner cannula <b>140</b> which is insertable through the lumen <b>142</b> of the outer cannula <b>112</b>. Inner cannula <b>140</b> includes a port <b>141</b> at an end thereof which lies adjacent port <b>121</b> when inner cannula <b>140</b> is inserted into its use orientation within outer cannula <b>112</b> and a port <b>143</b> which lies adjacent port <b>123</b> when inner cannula <b>140</b> is inserted into outer cannula <b>112</b>. Inner cannula <b>140</b> also includes a connector <b>160</b> for connecting the inner cannula <b>140</b> to a ventilator <b>162</b>, illustrated in block form in <figref idref="DRAWINGS">FIG. 6</figref> only, for the purpose of clarity, to inflate the wearer's lungs.

The inner cannula <b>140</b> also includes an opening <b>164</b> and a cooperating flap <b>166</b> adjacent the fenestration <b>134</b> of the outer cannula <b>112</b>. On pressurization of the inner cannula <b>140</b>, the flap <b>166</b> swings upward to the position illustrated in <figref idref="DRAWINGS">FIG. 6</figref> in which air from the ventilator <b>162</b> passes freely through the lumens <b>142</b>, <b>168</b> of the outer and inner cannulae <b>112</b>, <b>140</b>, respectively, into the lungs of the wearer <b>120</b>. The escape of air upward when the flap <b>166</b> is in this position is prevented by the cuff <b>116</b> and by the orientation of flap <b>166</b> illustrated in <figref idref="DRAWINGS">FIG. 6</figref> in which flap <b>166</b> seals against the seat <b>172</b>. However, the inner cannula <b>140</b>, including its flap <b>166</b>, is constructed so that, on depressurization of the ventilator <b>162</b>, the flap <b>166</b> swings downward to the position illustrated in <figref idref="DRAWINGS">FIG. 7</figref>, directing the exhaled air upward out of the inner cannula <b>140</b>, through the fenestration <b>134</b> with its flexible flap <b>136</b>, and upward into the pharynx <b>124</b> of the wearer <b>120</b> for use in producing speech. Seats <b>170</b>, <b>172</b> are provided for the flap <b>166</b> at the distal end of the inner cannula <b>140</b> and inside fenestration <b>134</b>, respectively, for when the flap <b>166</b> is in its positions illustrated in <figref idref="DRAWINGS">FIGS. 7 and 6</figref>, respectively. Seat <b>170</b> reduces the likelihood of the escape of exhaled gases back through the ventilator connector <b>160</b>. Orientation markers (not shown) may be provided on the proximal end <b>154</b> of the outer cannula <b>112</b> and the proximal end <b>146</b> of the inner cannula <b>140</b> to permit the proper orientation of flap <b>166</b> with respect to seat <b>170</b>.

Again, the flap <b>166</b> has somewhat the shape of a ping pong paddle in elevation, with the sealing portion of the flap <b>166</b> corresponding to the hitting portion of the paddle and the hinge portion of the flap <b>166</b> corresponding to the handle of the paddle. In order to reduce the likelihood of eversion of the flap <b>166</b> through its opening <b>164</b>, the flap <b>166</b> 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 <b>40</b> where it is attached by an appropriate adhesive, or inserted into an opening provided therefor in the wall of the cannula <b>140</b> where it is attached by an appropriate adhesive, or attached to the inner surface of the wall of the cannula <b>140</b> by an appropriate adhesive.

The tracheotomy tube system <b>110</b> can be quickly converted into a conventional tracheotomy tube by pushing the formed proximal end <b>180</b> of a somewhat blade-shaped lock <b>182</b> inward. See FIG. <b>6</b>. Lock <b>182</b> is slidable in a channel <b>184</b> provided therefor within lumen <b>168</b>. The distal end <b>186</b> of lock <b>182</b> lies adjacent the front surface of flap <b>166</b>. When lock <b>182</b> is slid distally in channel <b>184</b>, its distal end <b>186</b> interferes with the opening of flap <b>166</b> to its orientation illustrated in FIG. <b>7</b>. See FIG. <b>6</b>. This prevents the escape of air upward through opening <b>164</b>, but provides relatively unrestricted access through lumen <b>168</b> to the wearer <b>120</b>'s trachea <b>118</b>. Alternatively, the tracheotomy tube system <b>110</b> can be converted into a conventional tracheotomy tube by removing inner cannula <b>140</b> and inserting a non-fenestrated, non-valved conventional inner cannula (not shown) into lumen <b>142</b>. To provide positive positioning of blade <b>182</b> in one or the other of its non-speaking (<figref idref="DRAWINGS">FIG. 6</figref>) or speaking (<figref idref="DRAWINGS">FIG. 7</figref>) orientations, blade <b>182</b> is provided with two holes <b>188</b>, <b>190</b> adjacent its proximal end <b>180</b>. A nub <b>192</b> is provided on the inside wall of cannula <b>140</b> adjacent its proximal end. When blade <b>182</b> is in its speaking orientation (FIG. <b>7</b>), nub <b>192</b> engages in hole <b>188</b>. When blade <b>182</b> is in its non-speaking orientation (FIG. <b>6</b>), nub <b>192</b> engages in hole <b>190</b>.

The embodiments of <figref idref="DRAWINGS">FIGS. 1-5</figref> and <b>5</b>-<b>6</b><b>6</b>-<i><b>7</b></i>illustrate two different configurations of outer cannulae. While the configuration illustrated in <figref idref="DRAWINGS">FIGS. 1-5</figref> is easier to insert into, and remove from, the trachea of a wearer, the configuration illustrated in <figref idref="DRAWINGS">FIGS. 6-7</figref> 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 <b>112</b>and inner cannula <b>140</b> and rather less like the curved configuration of outer cannula <b>12</b>and inner cannula <b>40</b> . According to another aspect of the invention, an outer cannula <b>212</b> is provided which is constructed from a thermoplastic resin which has the somewhat more curved configuration of outer cannula <b>12</b> when outer cannula <b>212</b> is at temperatures somewhat lower than body temperature, illustrated in <figref idref="DRAWINGS">FIG. 8</figref>, but which reverts to the somewhat more inverted L configuration of outer cannula <b>112</b> when it is inserted into the trachea of a wearer. See FIG. <b>9</b>. This characteristic facilitates insertion of the outer cannula <b>212</b> into the trachea <b>218</b> of a wearer <b>220</b>, while providing the somewhat more natural inverted L configuration once the outer cannula <b>212</b> is inserted. Of course, removal is rendered somewhat more difficult, but such outer cannulae <b>212</b> typically reside for extended times in their wearers <b>220</b>.

In another embodiment constructed according to the invention and illustrated in <figref idref="DRAWINGS">FIGS. 10-11</figref>, a relatively pliable, for example, relatively low-durometer silicone, tracheotomy tube <b>250</b> of a somewhat L-shaped configuration is provided with a stylet <b>252</b> having a somewhat bullet-shaped remote end <b>254</b> for ease of insertion through a tracheostoma <b>256</b> into the trachea <b>258</b> of a wearer <b>260</b>. The proximal end <b>266</b> of the tracheotomy tube <b>250</b> is provided with some means such as, for example, a flange <b>268</b>, to permit the healthcare worker to hold the proximal end <b>266</b> of the tracheotomy tube <b>250</b> so that the stylet <b>252</b> can be inserted into the open proximal end <b>266</b> of the tube <b>250</b> and pushed the full length into the tracheotomy tube <b>250</b> to cause deflection of the relatively pliable tracheotomy tube <b>250</b> from its somewhat L-shaped configuration illustrated in <figref idref="DRAWINGS">FIG. 10</figref> into a somewhat more curved configuration illustrated in FIG. <b>11</b>. This configuration facilitates insertion of the tracheotomy tube <b>250</b> through the tracheostoma <b>256</b> and into the trachea <b>258</b> of the wearer <b>260</b>. Once the tracheotomy tube <b>250</b> is in place in the trachea <b>258</b> of the wearer <b>260</b>, the stylet <b>252</b> is removed, at which time the tracheotomy tube <b>250</b> returns from its somewhat more curved configuration illustrated in <figref idref="DRAWINGS">FIG. 11</figref> to its somewhat more L-shaped configuration illustrated in FIG. <b>10</b>.

To remove the tracheotomy tube <b>250</b> from the trachea <b>258</b> of the wearer <b>260</b>, the stylet <b>252</b> can be reinserted into the tracheotomy tube <b>250</b> to return it to its somewhat more curved configuration illustrated in <figref idref="DRAWINGS">FIG. 11</figref> prior to removing it from the trachea <b>258</b> of the wearer <b>260</b>. If this is done, the tracheotomy tube <b>250</b> comes out relatively easily. Alternatively, the tracheotomy tube <b>250</b> can be removed while still in its somewhat more L-shaped configuration. Although this requires somewhat more force than if the stylet <b>252</b> were used to render the tracheotomy tube <b>250</b> somewhat more curved in configuration, the tracheotomy tube <b>250</b> still can be removed without excessive effort or damage to the trachea <b>258</b> or tracheostoma <b>256</b> of the wearer <b>260</b>. The tracheotomy tube <b>250</b> is otherwise configured similarly to tracheotomy tube <b>112</b>, <b>140</b> illustrated in <figref idref="DRAWINGS">FIGS. 6-7</figref>.

While many details of the embodiments illustrated in <figref idref="DRAWINGS">FIGS. 1-7</figref> are eliminated from the illustrations of <figref idref="DRAWINGS">FIGS. 8-11</figref> for the purpose of clarity, it is to be understood that practical embodiments of the invention illustrated in <figref idref="DRAWINGS">FIGS. 8-11</figref> can be provided with, for example, secretion evacuation tubes like tubes <b>29</b>, <b>129</b> illustrated in <figref idref="DRAWINGS">FIGS. 1-7</figref>.