Valved fenestrated tracheotomy tube having outer and inner cannulae

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DESCRIPTION

Tracheostomy tube with a valved window, with an internal and external cannula.

This invention relates to improvements in tracheostomy tubes.

This invention is directed towards the problem of not being able to generate an audible laryngeal voice, and therefore, the inability to speak, faced by people whose breathing is always mechanically assisted by means of a respirator that is connected to a tracheostomy tube. with balloon that is introduced into the trachea of ​​a user below the level of the vocal cords. The balloon in the tracheostomy tube is inflated, for example, with air, so that this balloon substantially occludes the flow of fluid by pressing against the wall of the trachea. The purposes of the inflated balloon include: protecting against leakage of saliva and other secretions around the tracheostomy tube and into the lungs; and, preventing air that is delivered under pressure to the lungs by the respirator through the tracheostomy tube as well as exhalation from the lungs from escaping around the tracheostomy tube and out of the user's mouth and nose. In other words, the inflated balloon provides a closed mechanical respiratory system that is completely bypassed through the upper airways above the tracheostomy tube, including the vocal cords.

Side effects of this include eliminating the upward flow of exhaled air through the vocal cords. Naturally, this eliminates the possibility of generating audible speech and expressions.

Currently, there are only two options available to people undergoing mechanical ventilation through a balloon tracheostomy tube to generate audible voice and expressions with their own vocal cords. The first of these options is described in O. Hessler, MD, K. Rehder. MD, and SW Karveth, MC, USA, in "Tracheostomy Canaula for Speaking During Artificial Respiration", Anesthesiology, vol. 25, no.5, pp. 719-721 (1964). There is no known commercially available device manufactured as described in Hessler, et al.

The second option is a so-called “talking tracheostomy tube,” which is a conventional balloon tracheostomy tube made with an 8-10 French conduit running its entire length. The distal end of this conduit ends above the level of the inflated balloon. The proximal end of this conduit is connected to a source of, for example, compressed air. Examples of such a device have been manufactured by Sims-Portex, Inc., and Bivona Surgical Inc. The user of this device is able to stop and start the flow of compressed air towards the distal end of this duct, thus having the possibility of suspending and activating the flow of air upwards through their vocal cords, which allows the user to generate a voice. This flow of air from the voice is completely independent of the flow of respiratory air through the tracheostomy tube. Such talking tracheostomy tubes have been around for several years, but their use has not become widespread, perhaps due to their own and numerous mechanical limitations.

A ventilator-dependent patient breathing through a balloon tracheostomy tube does not allow this patient to generate an audible voice with their vocal cords, since the balloon of the tracheostomy tube that this patient is wearing prevents exhalations from giving go around the lower end of the tube and climb up through the vocal cords. This situation continues to hold until the wearer's condition is sufficiently improved that the balloon in the tracheostomy tube can be deflated so that exhaled air can pass around the tracheostomy tube and rise through the user's vocal cords, to the mouth and nose, thus allowing audible vocal cord vibrations to be generated to express themselves.

This invention alleviates this situation. When coupled to a ventilator with its balloon inflated, a valve tracheostomy tube system with a valve according to the invention directs the air in the inhalation cycle of the ventilator towards the lungs. Exhalations are directed by the valved balloon tracheostomy tube system in accordance with the invention into the upper airways, thus allowing vocal cord vibration and audible laryngeal expressions to be generated.

US Patent No. 5771888 reveals a tracheal cannula for the mechanical respiration of tracheostomized patients that has a balloon that wraps and closes the proximal section, which can be introduced concentrically into the trachea, a curved section placed above the balloon and an inner cannula that can inserted concentrically into the cannula from the distal end of the cannula, an exhalation opening being provided in the cannula above the balloon that closes the trachea and approximately in the extension of the longitudinal axis of the folded section that is introduced into the trachea, and, in its region located below the exhalation opening, the inner cannula consists of an opening, which is at least partially covered by an elastic membrane that acts as a valve, while at its proximal end the inner cannula consists of a region that is depressed in its cross section.

The present invention provides a tracheostomy apparatus consisting of an outer cannula having a first opening for orientation outside of the neck of a user, a second opening for orientation inside the trachea of ​​the user and a first passage conduit that couples the first opening to the second opening to allow the flow of gases from the first opening to the second opening during the inhalation carried out by the user and from the second opening during the exhalation by the user, a third opening between the first

ES 2 248 019 T5 and the second opening and a valve that controls the flow through the third opening, an inner cannula for its introduction inside the first passage through the first opening in case the user wishes be able to exhale through your pharynx, the inner cannula having a fourth opening for its orientation adjacent to the first opening, a fifth opening for its orientation adjacent to the second opening, and a second passage conduit that couples the fourth opening to the fifth opening to allow the flow of gases from the fourth opening to the fifth opening during inhalation by the user and from the fifth opening during exhalation by the user, wherein the valve adopts a first orientation to allow flow from the first opening to the second opening when the first opening is at a pressure higher than that of the second opening, and a second orientation that allows flow from the second opening passing through the third opening and prevents the passage of flow from the fourth opening when the second opening is at a pressure higher than that of the first opening.

Illustratively, according to the invention, a movable member and a seat are included in the valve. The movable element moves away from the seat to allow the passage of flow from the fourth opening to the fifth opening when the fourth opening is at a pressure higher than that of the fifth opening, and seats against the seat to prevent the passage of flow from the fifth opening passing through the fourth opening and activates the flow from the fifth opening passing through the third opening when the fourth opening is at a pressure below the of the fifth opening.

Illustratively, according to the invention, the seat is positioned in the second passageway.

Alternatively, Illustratively, according to the invention, the seat is positioned in the first passageway.

Additionally, according to the invention, a movable element and a seat are included in the valve. The movable element moves towards the seat to prevent the passage of flow from the fourth opening passing through the third opening when the fourth opening is at a pressure higher than that of the fifth opening, and moves away from the seat to allow the passage of flow from the fifth opening through the third opening when the fourth opening is at a pressure lower than that of the fifth opening.

Still more illustrative, according to the invention, the outer cannula is provided with an inflatable balloon between the second and third openings and with a third passage conduit for introducing the inflation fluid inside the balloon in situ in the trachea of ​​the user. to prevent the flow of fluids between the balloon and the trachea when the balloon is inflated.

In a further illustrative manner, according to the invention, the outer cannula is provided with a flexible element to cover the third opening.

Illustratively, according to the invention, the flexible element and the outer cannula comprise a first and second complementary fixation element, respectively, for fixing the flexible element to the outer cannula. The second fixation element provides a fixation point located within the third opening for the fixation of the first fixation element to the second fixation element at the fixation point.

Alternatively, Illustratively, according to the invention, the flexible element consists of a flexible membrane with a slit therein.

Alternatively, Illustratively, according to the invention, the flexible element consists of a tab to cover the third opening.

The invention may be better understood in conjunction with the detailed description that follows and the accompanying drawings, by which the invention is illustrated. In the drawings:

A partially fragmentary lateral section through the trachea, tracheostoma and lower pharynx of a user wearing a device according to the present invention is illustrated in Fig. 1;

Fig. 2 is an exploded perspective view of the device illustrated in Fig. 1;

A partially fragmentary and slightly enlarged lateral section through the trachea, tracheostoma and lower pharynx of a user wearing a device according to the present invention is illustrated in Fig. 3, with the device illustrated in the position it adopts. during exhalation by the user;

A partially fragmentary and slightly enlarged lateral section through the trachea, tracheostoma and lower pharynx of a user wearing the device of Fig. 3 is illustrated in Fig. 4, illustrated in another position;

A fragmentary cross-sectional view through the embodiment illustrated in Figs. 5 is illustrated in Fig. 5. 1 to 4, taken generally along section lines 5-5 of Fig. 4;

In Fig. 6 a partially fragmentary lateral section is illustrated through the trachea, the tracheostoma and the lower pharynx of a user who wears another device according to the present invention in the position that it adopts during exhalation by the user;

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Fig. 7 illustrates a partially fragmentary lateral section through the trachea, tracheostoma, and lower pharynx of a user wearing the device illustrated in Fig. 6, with the device shown in another position. that it adopts;

A partially fragmentary lateral section through the trachea, tracheostoma and lower pharynx of a user wearing another device according to the present invention is illustrated in Fig. 8, with the device illustrated in its orientation during insertion in the inside of the user's windpipe;

Figure 9 illustrates a partially fragmentary lateral section through the trachea, tracheostoma, and lower pharynx of a user wearing the device illustrated in Figure 8, with the device illustrated in the orientation that it is adopts after it has been inserted into the trachea of ​​the user and has been substantially warmed up to body temperature;

A partially fragmentary lateral section through the trachea, tracheostoma and lower pharynx of a user wearing another device constructed in accordance with the invention is illustrated in Fig. 10, with the device illustrated in an orientation of use; Y,

A partially fragmentary side section through the trachea, tracheostoma, and lower pharynx of a user wearing the device illustrated in Fig. 10 is illustrated in Fig. 10, with the device illustrated in one orientation. introduction.

Referring now to Figs. 1 to 5, a speaking tracheostomy tube system 10 consists of an outer cannula 12 for introduction into the tracheostoma 14. The outer cannula 12 consists of an inflatable balloon 16. The balloon 16 is located in the trachea 18 of the user 20 under passageway 22 upwardly into pharynx 24 of user 20. Balloon 16 is inflatable through line 26 (illustrated only in Fig. 1, for the purpose of clarity) after the outer cannula 12 is in place in the trachea 18 to prevent the passage of secretions 27 from the upper respiratory tract, including the pharynx 24, descending into the lungs of the user 20. Such secretions inevitably clump 27 above balloon 16 when balloon 16 is inflated in place.

To evacuate said grouped secretions 27, a tube 29 is extended in an indentation 31 provided for this in the lower part of the outer side wall of the outer cannula 12. The tube 29 ends in an open end 33 just above the level of the balloon 16. Pooled secretions 27 are evacuated by applying a vacuum 37 (illustrated in Fig. 2 only, for the purpose of clarity) to the outer end of tube 29.

Outer cannula 12 consists of a fixation plate 30 pivotally mounted adjacent to its proximal end 32 to facilitate fixation, for example, by a strap or tape around the wearer's neck 20. Likewise, outer cannula 12 consists of a fenestration 34 which allows the user 20 to speak by forcing the exhaled gases upward through the fenestration 34 and into the pharynx 24. The voice can be articulated based on known principles.

Although only one of said fenestrations 34 is illustrated, it is understood that for this purpose any number of fenestrations 34 may be provided in the outer cannula 12.

The fenestration 34 is covered by a flexible sheet 36 of, for example, a suitable elastomer, containing a slit 38 for the passage of exhaled gases upward through the pharynx 24. The flexible sheet 36 is provided to prevent leakage. development of the so-called granulation tissue of the trachea 18 inside the outer cannula 12 according to known principles. Although this covering 36 for the fenestration 34 is illustrated only once in the drawings, numerous techniques are known for covering the fenestration 34. See, for example, JP-A-2001079090 and WO-A-9932169.

Also included in the speaking tracheostomy tube system 10 is an inner cannula 40 which can be inserted through the lumen 42 of the outer cannula 12. Also, a connector portion 60 is included in the inner cannula 12 to connect the inner cannula. 40 to a ventilator 62, illustrated in block form only in Fig. 2, for the sake of clarity, to inflate the user's lungs.

Also included in inner cannula 40 is an opening 64 and a cooperating tab 66 adjacent to fenestration 34 of outer cannula 12. Upon pressurization of inner cannula 40, tab 66 assumes the position illustrated in FIG. 4 in which air passes freely from the ventilator 62 down the lumen 68 of the inner cannula 40 into the lungs of the user 20. Upward escape of air is prevented when the tab 66 is in this position by the balloon 16 and by the orientation of the tab 66 illustrated in Fig. 4 in which the tab 66 closes the opening 64. However, the Inner cannula 40, including its tab 66, is constructed so that, as fan 62 is depressurized, tab 66 moves to the position illustrated in FIG. 3, directing the exhaled air upwardly out of the inner cannula 40, through the fenestration 34 with its flexible slit sheet 36, and upward into the pharynx 24 of the user 20 to be used for the generation of the voice. A seat 70 for tab 66 is provided within inner cannula 40 when tab 66 is in position as illustrated in FIG. 4 to reduce the likelihood of backward exhaust of exhaled gases through the fan connector 60.

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The tab 66 may have a planar view that slightly resembles the shape of a ping pong racket, with the closing portion of the tab 66 corresponding to the striking portion of the racket, while the hinged portion of the Tab 66 corresponds to the handle of the racket. In order to reduce the probability of eversion of the tab 66 through its seat 70, this tab 66 can be constructed of a more rigid material, such as hardened silicone, or it can be molded with a reinforcement to provide greater rigidity. , such as, for example, an X-shaped molded wire reinforcement or an X-shaped protrusion on one or the other or both of the larger surfaces, or other similar shapes. The hinged portion, or handle of the ping pong racket, can, for example, be located in a notch provided for this in the wall of the cannula 40 where it is fixed by means of a suitable adhesive, or it can be inserted into a opening provided for this in the wall of the cannula 40 where it is fixed by means of a suitable adhesive, or it can be fixed to the inner surface of the wall of the cannula 40 by means of a suitable adhesive.

Typically, ventilators 62 are provided with mechanisms to measure the volume of gas exhaled and alarms to indicate when the volume of gas recovered during exhalation is much less than the volume of the exhaust gas during operation of the ventilators 62. in the pressurization phase. These mechanisms, or at least the alarms of these mechanisms, may have the possibility of being disconnected to prevent these alarms from beginning to sound during the use of the inner cannula 40 by the user 20 during the sessions in which he is speaking.

The tracheostomy tube system 10 can be rapidly converted to a conventional tracheostomy tube by pushing in the shaped proximal end 80 of the lock that slightly resembles a paddle shape 82. See Fig. 4. The lock 82 can slide into a channel 84 provided therefor within lumen 68. See FIG. 5. The distal end 86 of lock 82 is adjacent to the interior surface of tab 66. As lock 82 slides distally in channel 84, its distal end 86 interferes with opening tab 66 toward its orientation, as illustrated in Fig. 3. See Fig. 4. This prevents air leakage upward through aperture 64, but provides relatively unrestricted access to trachea 18 of user 20, through lumen 68. Alternatively, the tracheostomy tube system 10 can be converted to a conventional tracheostomy tube by removing the inner cannula 40 and inserting a conventional non-fenestration and valveless inner cannula (not shown) into the lumen 42. For the blade 82 has a positive positioning in one or the other of its orientations to not speak (Fig. 4) or speak (Fig. 3), the blade 82 is provided with two holes 88, 90 adjacent to its proximal end 80. A key 92 is provided within the wall of cannula 40 adjacent its proximal end. When paddle 82 is in its speaking orientation (Fig. 3), key 92 engages in hole 88. When paddle 82 is in its non-speaking orientation (Fig. 4), key 92 engages in hole 90.

In another embodiment of the invention that is illustrated in Figs. 6 and 7, a speaking tracheostomy tube system 110 consists of an outer cannula 112 for introduction into the tracheostoma 114. The outer cannula 112 consists of an inflatable balloon 116.

Balloon 116 is located in trachea 118 of user 120 below passageway 122 upward into pharynx 124 of user 120. Balloon 116 is inflatable through a line (not shown) after the outer cannula 112 in place in trachea 118 to prevent passage of secretions from the upper respiratory tract, including pharynx 124, descending into the lungs of user 120. A tube 129 extends into an indentation 131 provided for this in the lower part of the outer side wall of the outer cannula 112. The tube 129 terminates at an open end 133 just above the level of the balloon 116. The pooled secretions are evacuated by applying a vacuum (not shown) to the outer end of tube 129.

The outer cannula 112 consists of a fenestration 134 that allows the user 120 to speak by forcing the exhaled gases up through the fenestration 134 and into the pharynx 124. The voice can be articulated based on known principles. The fenestration 134 is covered by a flexible sheet 136 of, for example, a suitable elastomer, which is moved upwardly to the position illustrated with broken lines in Fig. 7, for the passage of the exhaled gases upwardly through the pharynx 124. Again, the tab 136 is provided to prevent the development of granulation tissue from the trachea 118 within the outer cannula 112. See , for example, JP-A-2001079090 and WO-A-9932169.

Also included in the speaking tracheostomy tube system 110 is an inner cannula 140 that can be inserted through the lumen 142 of the outer cannula 112. Also, in the inner cannula 12 is included a connector 160 to connect the inner cannula 140 to a ventilator 162, illustrated in block form only in FIG. 6, for the sake of clarity, to inflate the user's lungs.

Also included in the inner cannula 140 is an opening 164 and a cooperating tab 166 adjacent to the fenestration 134 of the outer cannula 112. Upon pressurization of the inner cannula 140, the tab 166 is rotated upward toward the position to be illustrated in FIG. 6 in which air passes freely from fan 162 through lumens 142, 168 of outer and inner cannulas 112, 140, respectively, into the lungs of user 120. Upward escape of air is prevented when the tab 166 is in this position by the balloon 116 and by the orientation of the tab 166 illustrated in FIG. 6 in which the tab 166 closes against the seat 172. However , the inner cannula 140, including its tab 166, is constructed so that, as the fan 162 is depressurized, the tab 166 moves to the position illustrated in Fig. 7, directing the

ES 2 248 019 T5 exhaled air ascending out of the inner cannula 140, through the fenestration 134 with its flexible tab 136, and ascending into the pharynx 124 of the user 120 to be used for the generation of the voice. Seats 170, 172 for tab 166 are provided at the distal end of inner cannula 140 and within fenestration 134, respectively, for when tab 166 is in its positions as illustrated in Figs. 7 and 6, respectively. Seat 170 reduces the likelihood of exhaust backward exhaust through fan connector 160. Orientation markers (not shown) may be provided at proximal end 154 of outer cannula 112 and proximal end 146 of inner cannula 140 to allow proper orientation of tab 166 relative to seat 170.

Once again, the tab 166 has a slightly raised ping pong racket shape, with the closing portion of the tab 166 corresponding to the striking portion of the racket, while the hinged portion of the tab 166 is corresponds to the handle of the racket. In order to reduce the probability of eversion of the tab 166 through its opening 164, this tab 166 can be constructed of a more rigid material, such as hardened silicone, or it can be molded with a reinforcement to provide greater rigidity. , such as, for example, an X-shaped molded wire reinforcement or an X-shaped protrusion on one or the other or both of the larger surfaces, or other similar shapes. Once again, the hinged portion, or handle of the ping pong racket, can be located in a notch provided for this in the wall of the cannula 140 where it is fixed by means of a suitable adhesive, or it can be inserted into a opening provided for this in the wall of the cannula 140 where it is fixed by means of a suitable adhesive, or it can be fixed to the inner surface of the wall of the cannula 140 by means of a suitable adhesive.

The tracheostomy tube system 110 can be rapidly converted to a conventional tracheostomy tube by pushing in the shaped proximal end 180 of the lock that slightly resembles a paddle shape 182. See Fig. 6. The lock 182 can slide into a channel 184 provided therefor within lumen 168. The distal end 186 of lock 182 is adjacent to the interior surface of tab 166. As lock 182 slides distally into channel 184, its distal end 86 interferes with opening tab 166 toward its orientation, as illustrated in Fig. 3. See Fig. 6. This prevents air leakage up through opening 164, but provides relatively unrestricted access to trachea 118 of user 120, through lumen 168. Alternatively, the tracheostomy tube system 110 can be converted to a conventional tracheostomy tube by removing the inner cannula 140 and inserting a conventional non-fenestration and valveless inner cannula (not shown) into the lumen 142. For the blade 182 has a positive positioning in one or the other of its orientations to not speak (Fig. 6) or speak (Fig. 7), blade 182 is provided with two holes 188, 190 adjacent its proximal end 180. A key 192 is provided within the wall of cannula 140 adjacent its proximal end. When paddle 182 is in its speaking orientation (Fig. 7), key 192 engages in hole 188. When paddle 182 is in its non-speaking orientation (Fig. 6), key 192 engages in hole 190.

In the embodiments of Figs. 1-5 and 5-6 illustrate two different configurations of outer cannulas. While the configuration illustrated in Figs. 1-5 is simpler to insert into, and remove from, a user's trachea, the configuration illustrated in Figs. 6-7 has a more natural shape. That is, the configuration of the trachea and tracheostoma of a user is configured much more like the inverted L configuration of the outer cannula 112 and the inner cannula 140 and much less like the curved configuration of the outer cannula 12 and the inner cannula 40.

According to another aspect of the invention, an outer cannula 212 is provided that is constructed of a thermoplastic resin that has a slightly more curved configuration of outer cannula 12 when outer cannula 212 is at temperatures slightly lower than body temperature, illustrated in Fig. 8, but reverting to a slightly more inverted L-configuration of outer cannula 112 when inserted into a user's trachea. See Fig. 9. This feature facilitates the introduction of the outer cannula 212 into the trachea 218 of a user 220, although it assumes the slightly more natural inverted-L configuration when the outer cannula 212 is inserted. Naturally, this makes extraction somewhat more difficult, but such outer cannulas 212 tend to remain longer in their wearers 220.

In another embodiment constructed according to the invention and illustrated in Figs. 10-11, a relatively flexible tracheostomy tube is provided, for example, a relatively low hardness silicone tracheostomy tube 250 of a slightly L-shaped configuration with a stylet 252 having a slightly bullet-shaped distal end 254 to facilitate its introduction into the trachea 258 through the tracheostoma 256 of a user 260. The proximal end 266 of the tracheostomy tube 250 is provided with some means such as, for example, a flange 268, to allow the healthcare worker to grasp the proximal end 266 of the tracheostomy tube 250 so that the stylet 252 can be inserted into the open proximal end 266 of the tube 250 and pushed its full length into the tracheostomy tube 250 to produce the deviation of the relatively flexible tracheostomy tube 250 from its slightly L-shaped configuration illustrated in Fig. 10 within the slightly more curved configuration illustrated in Fig. 11. This configuration facilitates the introduction of the tracheostomy tube 250 through the tracheostomy 256 and into the trachea 258 of the user 260. Once tracheostomy tube 250 is in place within trachea 258 of user 260, stylet 252 is removed, at which time tracheostomy tube 250 returns from its slightly more curved configuration illustrated in Fig. 11 to its slightly L-shaped configuration illustrated in Fig. 10.

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To remove tracheostomy tube 250 from trachea 258 of user 260, stylet 252 can be reinserted into tracheostomy tube 250 to return to its slightly more curved configuration illustrated in Fig. 11 prior to remove it from the trachea 258 of the user 260. After this has been done, the tracheostomy tube 250 comes out with relative ease. Alternatively, the tracheostomy tube 250 can be removed while still in its slightly L-shaped configuration. Although this requires somewhat more force than in the case where the stylet 252 was used to convert the trach tube 250 into a Slightly more curved, the tracheostomy tube 250 can still be removed without undue effort or without damaging the trachea 258 or tracheostoma 256 of the user 260. In contrast, tracheostomy tube 250 is configured similarly to tracheostomy tube 112, 140 illustrated in Figs. 6-7.

Although many details have been removed from the embodiments illustrated in Figs. 1-7 of the illustrations of Figs. 8-11 for the sake of clarity, it is understood that the practical embodiments of the invention illustrated in Figs. 8-11 may be provided with, for example, tubes for evacuating secretions such as tubes 29, 129 illustrated in Figs. 1-7.

Bibliographic references mentioned in the description

This list of bibliographic references mentioned by the applicant has been incorporated exclusively for the information of the reader. But it is not an integral part of the European patent documentation. Even though these bibliographic references have been compiled with the utmost care, errors or omissions cannot be excluded and the EPO declines all responsibility in this regard.

Documentation of the patent mentioned in the description • US 5771888 A • JP 2001079090 A • WO 9932169 A.

Documentation not related to the patent mentioned in the description • O. HESSLER, MD; K. REHDER. MD; SW KARVETH, MC. Tracheostomy Cannula for Speaking During Artificial Respiration. Anesthesiology, 1964, vol. 25 (5), 719-721.