Valved fenestrated tracheotomy tube having outer and inner cannulae

ES 2 248 019 T3

DESCRIPTION

Tracheostomy tube with windows and valve, which has outer and inner cannulas.

The present invention relates to improvements in tracheostomy tubes.

The present invention is aimed at solving the problem of inability to produce audible laryngeal voice, and therefore inability to speak, which affects individuals whose breathing is produced mechanically by a breathing apparatus that is connected to a tracheostomy tube fitted cuff, inserted into the trachea of ​​the user, below the level of the vocal cords. The cuff of the tracheostomy tube is inflated, for example, by air, so that the cuff closes tightly against the wall of the trachea. The objectives of the inflated cuff include: protection against outflow leaks and other secretions around the tracheostomy tube passing into the lungs; and also prevent air from being supplied under pressure from the respirator through the tracheostomy tube to the lungs and exhalation from the lungs from escaping around the tracheostomy tube, passing out through the user's mouth and nose. In other words, the inflated cuff provides a closed mechanical respiratory system that completely bypasses the upper airways above the level of the tracheostomy tube, including the vocal cords. Side effects of this include elimination of the air flow exhaled up through the vocal cords. Of course, this eliminates the production of voice and audible speech.

Currently, there are two options available to individuals mechanically ventilated using a cuffed tracheostomy tube to produce audible voice and speech with their own vocal cords. The first of these options is described in O. Hessler, MD, K. Rehder. MD, and SW Karveth, MC, USA, "Tracheostomy Cannula for Speaking During Artificial Respiration", Anesthesiology, vol. 25, no.5, pp. 719-721 (1964). There is no commercially available device constructed as described by Hessler et al.

The second option is a so-called “speaking tracheostomy tube,” which is a conventional cuffed tracheostomy tube made with a longitudinally extending 8-10 French conduit. The distal end of this conduit terminates above the level of the inflated cuff. The proximal end of this conduit is connected, for example, to a source of compressed air. Examples of such a device are manufactured by Sims-Portex, and Bivona Surgical Inc. The user of said device is able to interrupt and initiate the flow of compressed air to the distal end of this conduit, thus making it possible to interrupt and start the flow of air up through the vocal cords, enabling the user to generate voice. This voice airflow is completely independent of the respiratory airflow through the tracheostomy tube. These speaking tracheostomy tubes have been known for several years, but are not widely used, perhaps due to numerous mechanical limitations.

A cuffed tracheostomy tube for breathing a patient dependent on a ventilation device is unable to produce audible voice with the user's vocal cords because the cuff of the tracheostomy tube prevents exhalations from passing around the lower end of the tube, passing into the up through the vocal cords. This situation continues until the condition of the user improves sufficiently so that the cuff of the tracheostomy tube can be deflated so that the exhaled air can pass around the tracheostomy tube upwards, passing through the vocal cords, mouth and nose, allowing audible vibrations of the vocal cords for the purpose of producing speech.

The present invention alleviates this situation. When attached to a breathing device with its cuff inflated, a valved cuffed tracheostomy tube system in accordance with the present invention directs air in the inhalation cycle of the breathing device into the lungs. Exhalations are directed by the valved cuff tracheostomy tube system, according to the invention, into the upper airways, allowing vibration of the vocal cords and generation of audible laryngeal speech.

According to one aspect of the invention, an outer cannula has a first opening for orientation outside the neck of the wearer, a second opening for orientation within the trachea of ​​the wearer, a first passage that couples the first opening to the second opening to allow the flow of gases from the first opening to the second during inhalation by the user and from the second opening during exhalation by the user, as well as a third opening between the first and second openings. An inner cannula is configured for insertion into the first passage through the first opening when the user wishes to be able to exhale air through their pharynx. The inner cannula comprises a fourth opening for orientation adjacent to the first opening, a fifth opening for orientation adjacent to the second opening, and a second coupling passage from the fourth opening to the fifth to allow the flow of gases from the fourth opening to the fifth, during inhalation by the user and from the fifth opening during exhalation by the user. A valve controls the flow through the third opening. The valve assumes a first orientation to allow flow from the first opening to the second opening when the first opening is at a higher pressure than the second, and a second orientation to allow flow from the second opening through the third. opening when the second opening is at higher pressure than the first.

Illustratively and in accordance with the invention, the valve includes a movable member and a seat. The movable member moves away from the seat to allow flow from the fourth opening to the fifth, when the fourth opening is at a higher pressure than the fifth, and is arranged against the seat to prevent flow from the fifth opening to through the fourth opening, and provides flow from the fifth opening through the third opening, when the fourth is at a lower pressure than the fifth opening.

Illustratively, in accordance with the invention, the valve seat is arranged in the second passage.

Illustratively and alternatively, according to the invention, the seat is arranged in the first step.

ES 2 248 019 T3

Additionally, according to the invention, the valve comprises a movable element and a seat. The movable member moves towards the seat to prevent flow from the fourth opening through the third, when the fourth opening is at a higher pressure than the fifth opening, and moves away from said seat to allow flow from the fifth opening through the third when the fourth opening is at a lower pressure than the fifth opening.

Additionally and illustratively, according to the invention, the outer cannula comprises an inflatable cuff between the second and third openings and a third passage for the introduction of an inflation fluid into the cuff in situ in the trachea of ​​the user to prevent flow of fluids between the cuff and the trachea when the cuff is inflated.

Illustratively and additionally, according to the invention, the outer cannula comprises a flexible element to cover the third opening.

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

Alternatively and illustratively, in accordance with the invention, the flexible element comprises a flexible membrane having a groove.

Alternatively and illustratively, according to the invention, the flexible element comprises a fin to cover the third.

The invention can be better understood by referring to the following detailed description and illustrative drawings showing the invention. In the drawings:

Figure 1 shows a partial lateral section of the trachea, tracheostoma and lower pharynx of a user of a device according to the present invention;

Figure 2 shows a perspective view, with parts removed, of the device shown in Figure 1;

Figure 3 shows a somewhat enlarged view, in partial lateral section, through the trachea, tracheostoma and lower pharynx of a user wearing a device according to the present invention, with the device shown in the position it adopts during exhalation through the Username;

Figure 4 shows a partial side sectional view, somewhat enlarged, through the trachea, tracheostoma and lower pharynx of a user wearing the device of Figure 3 shown in another position;

Figure 5 shows a partial sectional view through the embodiment shown in Figures 1-4, generally made along section lines 5-5 of Figure 4;

Figure 6 shows a partial lateral section through the trachea, tracheostoma and lower pharynx of a user wearing another device according to the present invention in the position that the user assumes during exhalation;

Figure 7 shows a partial lateral section of the trachea, tracheostoma and lower larynx of a user wearing the device shown in Figure 6, with the device shown in another position that it adopts;

Figure 8 shows a side view, partial through the trachea, tracheostoma and lower pharynx of a user wearing another device according to the present invention, with the device illustrated in its orientation during insertion into the user's trachea;

Figure 9 shows a partial lateral section, through the trachea, tracheostoma and lower larynx of a user wearing the device shown in Figure 8, with the device illustrated in the orientation it adopts once it has been inserted into the user's trachea and warmed substantially to body temperature;

Figure 10 shows a side view in partial section, through the trachea, tracheostoma and lower larynx of a user wearing another device constructed according to the invention, with the device shown in the orientation of use; and, Figure 11 shows a side view in partial section through the trachea, tracheostoma and lower pharynx of a user wearing the device shown in Figure 10, with the device shown in the insertion orientation.

Referring now to Figures 1-5, a speaking tracheostomy tube system (10) comprises an outer cannula (12) for insertion into the tracheostoma (14). The outer cannula (12) comprises an inflatable cuff (16). The cuff (16) is located in the trachea (18) of the user (20) below the passage (22) upwards, inside the pharynx (24) of the user (20). The cuff (16) is inflatable via a conduit (26) (shown only in Figure 1, for clarity purposes) once the outer cannula (12) is in place in the trachea (18) to prevent passage of secretions (27) from the upper respiratory tube, including the pharynx (24), descending past the user's lungs (20). These secretions inevitably cause a buildup (27) above the cuff (16) when the cuff (16) is inflated in place. To evacuate said secretions (27), a tube (29) is extended in an indentation (31) arranged for this purpose below the external lateral wall of the outer cannula (12). The tube (29) terminates at an open end (33) just above the level of the sleeve (16). The accumulated secretions (27) are evacuated by the application of vacuum (37) (shown only in figure 2, with the objective of clarity) towards the external end (35) of the tube (29).

The outer cannula (12) comprises a pivotally mounted coupling plate (30) adjacent its proximal end (32) to facilitate coupling, for example, by means of a band or tape around the wearer's neck (20). The outer cannula (12) also includes a window (34) that allows the user (20) to speak by forcing the exhaled gases upward through the window (34) and into the pharynx (24). Speech can be articulated under these conditions according to known principles. While only a single window (34) has been shown, it should be understood that any number of windows (34) may be provided in the outer cannula (12) for this purpose. The window (34) is covered by a flexible sheet (36) made, for example, of a suitable elastomer, which contains a slot (38) for passage of the exhaled gases upwards through the pharynx (24). The flexible sheet (36) is

ES 2 248 019 T3 arranged to prevent the growth of the so-called granulation tissues of the trachea (18), into the outer cannula (12), according to known principles. Although this covering (36) for the window (34) is the only one that has been shown in the drawings, numerous techniques are known for covering the window (34). See, for example, JP-A-2001079090 and WO-A-9932169.

The speaking tracheostomy tube system (10) also includes an inner cannula (40) that can be inserted through the chamber (42) of the outer cannula (12). The inner cannula (12) also includes a connector (60) for connecting the inner cannula (40) to a ventilation device (62), shown in block form only in Figure 2, for the purpose of clarity, for purposes of inflate the user's lungs.

The inner cannula (40) also includes an opening (64) and an associated fin (66) adjacent the window (34) of the outer cannula (12). By establishing the pressure of the inner cannula (40), the fin (66) assumes the position shown in figure 4 in which the air from the ventilator device (62) passes freely towards the chamber (68) of the inner cannula (40 ) passing into the user's lungs (20). The upward escape of air when the flap (66) is in this position is prevented by the sleeve (16) and by the orientation of the flap (66) shown in Figure 4, in which said flap (66) closes sealing the opening (64). However, the inner cannula (40), including its fin (66), is constructed in such a way that, by removing the pressure from the fan device (62), the fin (66) moves to the position shown in figure 3 , directing the exhaled air upward out of the inner cannula (40), passing through the window (34) with its flexible slotted sheet (36), and upward into the pharynx (24) of the user (20) for its use in voice generation. A seat (70) for the flap (66) is disposed within the inner cannula (40) when the flap (66) is in its position shown in the figure to reduce the probability of escape of the exhaled gases back through. connector (60) of the fan device.

The fin (66) may have a plan view that takes the shape of a ping pong paddle to some extent, with the staking portion of the fin (66) corresponding to the percussion portion of the paddle, and the flap hinge (66) corresponds to the handle of the paddle. To reduce the probability of escapement of the fin (66) through its seat (70), the fin (66) can be constructed of a more rigid material, such as, for example, a more rigid silicone, or it can be molded with a reinforcement to give it rigidity, such as, for example, an x-shaped molded wire reinforcement or an x-shaped protrusion on either or both of its major surfaces, or other similar measures. The hinge, or handle of the ping pong paddle, can be located, for example, in a groove provided for the same in the wall of the cannula (40) where it is fixed by an appropriate adhesive, or it can be inserted into an opening. arranged therefor on the wall of the cannula (40) where it is fixed by an appropriate adhesive, or it can be fixed to the inner surface of the wall of the cannula (40) by an appropriate adhesive.

Typically, ventilator devices (62) are provided with mechanisms to measure the volume of exhaled gas and alarm elements to indicate when the volume of gas recovered during exhalation is much less than the volume of gas output during the exhalation phase. for pressurizing the fan devices (62). These mechanisms, or at least the alarms thereof, may have to be switched off to prevent the alarms from sounding during use of the inner cannula (40) by the user (20) during speaking sessions.

The tracheostomy tube system (10) can be rapidly converted to a conventional tracheostomy tube by pushing the proximal end (80) of a closure (82) that is approximately in the shape of a blade inward. See figure 4. The closure (82) is sliding in a channel (84) arranged therefor within the chamber (68). See Figure 5. The distal end (86) of the closure (82) is disposed adjacent the interior surface of the flap (66). When the closure (82) is slid away within the channel (84), its distal end (86) interferes with the opening of the flap (66) to the orientation shown in figure 3. See figure 4. This prevents escape of air up through the opening (64), but provides relatively free access through the chamber (68) to the trachea (18) of the user (20). Alternatively, the tracheostomy tube system (10) can be converted to a conventional tracheostomy tube by removing the inner cannula (40) and inserting a conventional valveless, windowless inner cannula (not shown) into the chamber ( 42). To provide the positive positioning of the blade (82) in one or other of its orientations, respectively, of speechless (figure 4) or with speech (figure 3), the blade (82) is provided with two holes (88) , (90) adjacent to its proximal end (80). A small projection (92) is disposed on the inner wall of the cannula (40) adjacent its proximal end. When the blade (82) is in its speaking orientation (FIG. 3), the projection (92) engages in the hole (88). When the blade (82) is in its speechless orientation (FIG. 4), the projection (92) engages in the hole (90).

In another embodiment of the invention shown in Figures 6-7, a speaking tracheostomy tube system (110) includes an outer cannula (112) for insertion into a tracheostoma (114). The outer cannula (112) comprises an inflatable cuff (116). The cuff (116) is located in the trachea (118) of the user (120) below the passage (122) up into the pharynx (124) of the user (120). The cuff (116) is inflatable via a conduit (not shown) once the outer cannula (112) is in place in the trachea (118) to prevent the passage of secretions from the upper respiratory tube, including the pharynx ( 124), downward, into the user's lungs (120). A tube (129) extends in an indentation (131) provided therefor below the outer side wall of the outer cannula (112). Tube (129) terminates at open end (133) just above sleeve (116). The accumulated secretions are evacuated by the application of vacuum to the outer end (not shown) of the tube (129).

The outer cannula (112) comprises a window (134) that allows the user (20) to speak by forcing exhaled gases upward through the window (134) and into the pharynx (124). Then the voice can be articulated according to principles co7

ES 2 248 019 T3 known. The window (134) is covered by a flexible flap (136) made, for example, of a suitable elastomer, which moves upwards to the position shown in broken lines in Figure 7, for the passage of gases exhaled upwards through the pharynx (124). Also in this case, the flap (136) is arranged to prevent the growth of granulation tissues from the trachea (118) into the outer cannula (112). See, for example, JP-A-2001079090 and WO-A-9932169.

The speaking tracheostomy tube system (110) also comprises an inner cannula (140) that can be inserted through the chamber (142) of the outer cannula (112). The outer cannula (112) also comprises a connector (160) for connecting the inner cannula (140) to a ventilator device (162), shown in the form of blocks only in figure 6, for the purpose of greater clarity, to inflate the user's lungs.

The inner cannula (140) also comprises an opening (164) and an associated fin (166) adjacent the window (134) of the outer cannula (112). By pressurizing the inner cannula (140), the fin (166) billows up to the position shown in Figure 6, in which the air from the fan (162) passes freely through the chambers (142), (168) of the outer and inner cannulas (112), (140), respectively, passing into the user's lungs (120). The upward escape of air when the flap (166) is in this position is prevented by the sleeve (116) and by the orientation of the flap (166) shown in Figure 6, in which the flap (166) closes tightly by action against the seat (172). However, the inner cannula (140), including its fin (166), is constituted in such a way that upon depressurization of the fan (162), the fin (166) vasculates down to the position shown in the figure. 7, directing the exhaled air upward, passing out of the inner cannula (140), through the window (134) with its flexible flap (136), and upward into the pharynx (124) of the user ( 120) for use in voice generation. Seats 170, 172 are arranged for fin 166 at the distal end of inner cannula 140 and inner window 134, respectively, for when fin 166 is in the positions shown. , respectively, in Figures 7 and 6. The seat (170) reduces the probability of escape of the exhaled gases again through the connector (160) of the ventilator. Orientation markers (not shown) may be disposed at the proximal end (154) of the outer cannula (112) and the proximal end (146) of the inner cannula (140) to allow proper orientation of the fin (166). with respect to the seat (170).

Also in this case, the fin (166) has in a certain way the shape of a ping pong paddle seen in elevation, with the sealing part of the fin (166) corresponding to the percussion part of the paddle and the part of articulation of the fin (166) corresponding to the handle of the paddle. In order to reduce the probability of escapement of the fin (166) through its opening (164), the fin (166) can be constructed from a more rigid material, such as, for example, a more rigid silicone, or it may be molded with a reinforcement to give it rigidity, such as, for example, an X-shaped molded wire reinforcement or an X-shaped protrusion on one or the other, or both, of its major surfaces, or the like. Also in this case, the hinge or handle of the ping pong paddle can be located in a groove provided for it in the wall of the cannula (40) in which it is fixed by an appropriate adhesive, or inserted into an opening arranged to this on the wall of the cannula (140) where it is fixed by an appropriate adhesive, or fixed to the inner surface of the wall of the cannula (140) by an appropriate adhesive.

The tracheostomy tube system (110) can be rapidly converted to a conventional tracheostomy tube by pushing the shaped proximal end (180) of a closure (182) in a blade-like fashion inward. See figure 6. The closure (182) is sliding in a channel (184) arranged for it inside the chamber (168). The distal end (186) of the closure (182) is disposed adjacent to the front surface of the flap (166). When the closure (182) slides distally in the channel (184), its distal end (186) interferes with the opening of the flap (166) to the orientation shown in figure 7. See figure 6. This prevents air escapes upward through opening (164), but provides relatively unrestricted access through chamber (168) to trachea (118) of user (120). Alternatively, the tracheostomy tube system (110) can be converted to a conventional tracheostomy tube by removing the inner cannula (140) and inserting a conventional valveless, windowless inner cannula (not shown) into the chamber ( 142). To achieve a positive positioning of the blade (182) in one or other of its orientations without speech (figure 6) or with speech (figure 7), the blade (182) is provided with two adjacent holes (188), (190) to its proximal end (180). A projection (192) is disposed on the inner wall of the cannula (140) adjacent its proximal end. When the blade (182) is in the speaking orientation (FIG. 7) the projection (192) engages in the hole (188). When the blade (182) is in its speechless orientation (FIG. 6), the projection (192) engages in the hole (190).

The embodiments of Figures 1-5 and 5-6 show two different configurations of the outer cannula. While the configuration shown in Figures 1-5 is easier to insert into and remove from the user's trachea, the configuration shown in Figures 6-7 is more naturally shaped. That is, the configuration of the trachea and tracheostoma of the user is configured more similarly to the inverted L configuration of the outer cannula (112) and the inner cannula (140), and less in the shape of 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 which is constructed from a thermoplastic resin, which has, in a way, a more curved configuration of the outer cannula (12) when the outer cannula ( 212) is at temperatures somewhat lower than body temperature, shown in Figure 8, but regaining the somewhat more inverted-L shape of the outer cannula (112) when the user's trachea is inserted. See figure 9. This feature facilitates insertion of the outer cannula (212) into the trachea (218) of the user (220), while providing the most natural inverted-L configuration once the outer cannula (212) has been inserted. Of course, disassembly is somewhat more difficult, but this type of

ES 2 248 019 T3 outer cannula (212) typically resides for a long time in the wearer's body (220).

In another embodiment constructed in accordance with the invention, and shown in Figures 10-11, a tracheostomy tube (250) with a shape similar to an L, made of a silicone with a relatively low durometer reading, is provided from a stylet ( 252) having a distal end (254) shaped like a bullet, to facilitate insertion through the tracheostoma (256) into the trachea (258) of the user (260). The proximal end (266) of the tracheostomy tube (250) is provided with certain means, such as, for example, a flange (268) to allow the healthcare worker to hold 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 can be pushed through its entire length into the tracheostomy tube (250) causing the relatively flexible tracheostomy tube (250) to flex out of its substantially L-shaped configuration, shown in Figure 10, to a somewhat more curved configuration, shown in Figure 11. This configuration facilitates insertion of the tracheostomy tube (250) through the tracheostoma (256) and into the trachea (258) of the user (260). Once the tracheostomy tube (250) is in place in the trachea (258) of the user (260) the stylet (252) is removed, at which point the tracheostomy tube (250) returns from its configuration somewhat more curved, shown in figure 11, to its configuration more corresponding to the shape of L, which is shown in figure

10.

To disassemble the tracheostomy tube (250) from the trachea (258) of the user (260), the stylet (252) can be reinserted into the tracheostomy tube (250) to return to its somewhat more curved configuration, which has been shown in Figure 11, before disassembling it from the trachea (258) of the user (260). If this operation is performed, the tracheostomy tube 250 comes out relatively easily. Alternatively, the tracheostomy tube (250) can be withdrawn while still in an L shape. While this requires somewhat greater force than using the stylet (252) to make the tracheostomy tube (250 ) acquires a more curved shape, the tracheostomy tube (250) can still be disassembled without undue effort or damage to the trachea (258) or tracheostoma (256) of the user (260). Tracheostomy tube 250 is otherwise configured similarly to tracheostomy tube 112, 140 shown in Figures 6-7.

While many details of the embodiments shown in Figures 1-7 have been removed from the illustrations of Figures 8-11 for the sake of clarity, it should be understood that the practical embodiments of the invention shown in Figures 8- 11 can be provided, for example, with secretion evacuation tubes, such as the tubes (29), (129) shown in Figures 1-7.