VENTILATION DEVICE WITH STOMA CUFFS

Description

[0001] The present invention relates to a ventilation device, in particular a tracheostomy cannula, comprising a cannula tube, a first inflatable cuff for sealing the trachea and a second inflatable cuff for sealing the stoma.

[0002] To ensure that the air flows almost completely through a tracheostomy tube during both inhalation and exhalation, many commercially available products of this type feature an inflatable cuff. This cuff seals the trachea around the tracheostomy tube, preventing air from passing through the natural airways. Since this also prevents exhaled air from bypassing the voice-producing organs, a patient with a blocked cuff typically has no ability to produce voice (phonation).

[0003] For this purpose, the method known as above-cuff vocalization (ACV) was developed. This method uses a separate air line to introduce air from the outside into the subglottic space between the cuff and the glottis. This air can then escape through the natural airways and, with some practice, be used by the patient for speaking.

[0004] Some commercially available tracheostomy tubes feature a speech air line in the form of a tube attached to the tube end for supplying air to the subglottic area. The outer end of the tube can be connected to a compressed air source, e.g., via a Y-piece or a connector. A valve, a regulator, or a fingertip connector can be used to control when the compressed air flows into the subglottic area via the speech air line.

[0005] Instead of tracheostomy tubes specifically designed for ACV, tubes with a subglottic suction channel are often used. The subglottic suction channel actually serves to remove secretions that have accumulated above the cuff. For this purpose, negative pressure is applied to the suction channel, which allows the secretions to be suctioned out of the subglottic area. An example of a tracheostomy tube with subglottic suction is described in EP 1 219 317 B1.

[0006] If the flow direction of a cannula with a subglottic suction channel is reversed after suctioning, compressed air can be introduced into the subglottic area via the suction channel, which can then escape as speech air through the natural airways. However, the speech air supply via a subglottic suction channel has the disadvantage that secretion still present on the canal wall after suctioning dries out due to the compressed air. The dried secretion sticks to the canal wall and hardens it. Over time, this leads to the suction channel becoming impermeable and thus losing its function. Therefore, a separate speech air supply is desirable, which is particularly easy to implement with cannulas or tubes that already have a subglottic suction channel.

[0007] All of the solutions mentioned so far only work if the tracheostomy tube fits tightly within the tracheostomy. However, many patients have a tracheostomy (hereinafter referred to as a stoma) that is significantly larger than the outer diameter of the tracheostomy tube. This is often the case, especially with surgically created stomas or older stomas.

[0008] Thus, in these patients, there is a gap between the cannula and the tissue surrounding the stoma. Since air always takes the path of least resistance, a large portion of the air escapes through this opening rather than through the natural airway. This has a significantly negative impact on speech quality.

[0009] In principle, it is possible to seal an oversized stoma with a custom-made prosthesis. However, since this is very complex, such a prosthesis is unfortunately not made for every patient who would benefit from it.

[0010] US Patent No. 4,459,984 A1 describes a tracheostomy tube with an inflatable cuff at the level of the stoma, designed to seal the stoma. However, it has been shown that such a cuff can easily cause pressure sores, which are very painful for the patient. The constant pressure on the tissue appears to be very problematic for the sensitive stoma.

[0011] Attempts were therefore made to use cuffs made of particularly soft silicone. However, when the cuff is made of such soft silicone, the problem arises that air diffuses through the silicone cuff over time. Thus, the diameter of the inflated cuff decreases over time. This often leads to the user inflating the cuff with more air than necessary to ensure the seal lasts as long as possible. This, in turn, promotes the formation of pressure sores.

[0012] Furthermore, the diameter of the stoma is not always constant, but can change depending on the patient's posture and muscle tone. This then directly influences the pressure exerted by the cuff on the stoma tissue. If the pressure is consistently higher than 30 mbar, the patient will develop pressure sores. If the pressure is too low, however, leaks occur, which in turn make speech difficult.

[0013] The following documents are also known from the prior art, namely DE 103 61 428 B3 and US 5 499 625 A.

[0014] In order to overcome the disadvantages associated with the technical solutions already existing in the prior art, the invention proposes a ventilation device, in particular a tracheostomy cannula, comprising ▪ a cannula tube, the tube wall of which has an extracorporeal section, a stoma section and a tracheal section, ▪ a first inflatable cuff which extends in a ring shape around the cannula tube in the tracheal section on the outside of the tube wall, ▪ a first air line which has an air outlet in the lumen of the first cuff, ▪ a second inflatable cuff which extends in a ring shape around the cannula tube in the stoma section on the outside of the tube wall, and ▪ a second air line which has an air outlet in the area between the stoma section and the first cuff, characterized in that the second air line has an additional air outlet into the lumen of the second cuff in the region of the stoma section.

[0015] When used as intended, the ventilation device according to the invention rests against the tissue surrounding a patient's stoma in the area of ​​the stoma section. From this stoma section, the extracorporeal section extends proximally and the tracheal section extends distally.

[0016] The terms "distal" and "proximal" are used in the context of the present invention from the perspective of a physician using the ventilator, i.e., the proximal end is the end of the ventilator that remains outside the patient's body after insertion into the trachea, while the distal end is inserted into the patient's trachea.

[0017] The term "duct" in the context of the present invention is understood to mean an air-conducting duct into which air can flow at the at least one provided air inlet and from which the air can flow out again at the at least one provided air outlet after the air has flowed through the otherwise airtight duct over a certain distance.

[0018] The second air line proposed according to the invention, which has an additional air outlet into the lumen of the second cuff in the area of ​​the stoma section, ensures that the second cuff is inflated when speech air flows through the second air line, thus sealing any gap that may exist between the tracheostomy tube and the stoma tissue at the moment the speech air is supplied. This significantly improves the quality of voice production without the risk of pressure sores occurring at the stoma, because the pressure load on the stoma tissue from the inflated cuff only occurs during the ACV process, but not during pauses in speech when no air flows through the speech air line.

[0019] Preferably, the second cuff occupies a volume in the stoma at a speech air flow rate of 2 to 10 liters / minute, sealing the stoma. In particularly preferred embodiments, the sealing volume is occupied by the second cuff in the range of 4 to 6 liters / minute. The diameter of the second cuff required for sealing at a speech air flow rate of 2 to 10 liters / minute or in the range of 4 to 6 liters / minute depends on the size of the patient's stoma, to which the cuff conforms during the speech phase.

[0020] For the purposes of this invention, the term "ambient pressure" refers to the pressure acting on the cuff. For a ventilator that is not in use, is not inserted into a stoma, and has no speech air flow through its second air line, the ambient pressure corresponds to atmospheric pressure and acts equally on both the outward-facing and inward-facing sides of the second air line and the second cuff.

[0021] If speech air is fed through the second air line (speech air line), a correspondingly increased overpressure acts on the inward-facing side of the cuff. If the ambient pressure acting on the cuff from the outside also increases, this overpressure counteracts the increased pressure exerted by the speech air on the inward-facing side of the cuff.

[0022] The ambient pressure acting on the cuff from the outside can either be pressure acting on the cuff from surrounding tissue or air pressure acting on the cuff of the air line from the outside.

[0023] In certain embodiments of the invention, the maximum diameter of the second cuff (stoma cuff) is reduced by at least 10% when the overpressure acting on the outside of the cuff exceeds 30 mbar, compared to the maximum diameter that occurs when speech air flows through the second air line at a speech air volume flow of 5 liters per minute. If speech air no longer flows through the second air line, the diameter is reduced by at least 10% when the overpressure acting on the outside of the cuff is less than 30 mbar.

[0024] In certain embodiments, the second air line is a pure speech air line, through which only speech air is conducted. In other embodiments, the second air line is a subglottic suction line, through which subglottic secretion can be suctioned in one direction and through which speech air can be conducted in the other direction.

[0025] In various embodiments of the invention, the second air line runs either in the tube wall of the cannula tube or on the outside of the tube wall of the cannula tube or on the inside of the tube wall of the cannula tube.

[0026] In certain embodiments, the second air line ends in the proximal-distal direction at or immediately after the transition from the stoma section to the tracheal section and opens into the trachea with its air outlet there.

[0027] In other embodiments, the second air line extends distally from the stoma section over up to 20%, up to 40%, up to 60% or up to 80% of the length of the path between the transition from the stoma section to the tracheal section and the first cuff (tracheal cuff).

[0028] The speaking air is typically provided by a compressed air device that can provide a speaking air volume flow of at least 5 l / min through the lumen of the second air line. The speaking air volume flow is the volume that flows through the second air line within a specific time when the ventilation device according to the invention is used as intended. This is preferably the standard volume in a standardized reference atmosphere at 20 °C and 1000 mbar. The speaking air volume flow is preferably measured in dry compressed air (p(H 2 O) = 0 kPA). The standard volume is preferably determined in a standardized reference atmosphere in accordance with DIN 1945-1.

[0029] In some embodiments, the maximum diameter of the stoma cuff is achieved by stretching the cuff material, which occurs at a speech air flow rate of 5 l / min and an ambient pressure of 1000 mbar. In these embodiments, the reduction in diameter due to increased ambient pressure or reduced flow rate occurs as the stretch of the cuff material decreases.

[0030] In other embodiments, the maximum diameter is achieved by the cuff material being stretched by the speech air at a speech air volume flow of 5 l / min and an ambient pressure of 1000 mbar, depending on the embodiment, against the effect of gravity or the inherent tension of the cuff, without the cuff stretching. The reduction in diameter due to increased ambient pressure or reduced volume flow occurs in these embodiments because the cuff at least partially collapses. In special embodiments, the diameter is achieved partly by stretching the cuff and partly by stretching the cuff due to a speech air volume flow of 5 l / min at an ambient pressure of 1000 mbar.

[0031] Some embodiments of the invention are characterized in that the second inflatable cuff, with an air flow of 5 liters per minute through the second air line, has an outer diameter in the free state outside a patient that is at least 20% larger than the outer diameter of the cannula tube at the level of the cuff. This applies in particular to embodiments of the invention in which the cuff material does not expand significantly, but rather conforms to the stoma wall by means of folds (HVLP cuff = High Volume Pressure Low Cuff ) . Preferably, the outer diameter of the cuff in the fully inflated free state is at least 30%, at least 40% or at least 50% larger than the outer diameter of the cannula tube.

[0032] For a given air flow of 5 liters / minute, the system with an HVLP cuff is preferably calibrated to create a pressure between 10 mbar and 60 mbar, preferably 20 to 30 mbar, in the cuff. For a system with an expandable cuff, however, a pressure between 40 and 80 mbar is preferred, as part of this pressure is required to overcome the restoring forces of the elastic material.

[0033] In certain embodiments of the present invention, the speech air supply is formed at least in sections by a layer of film that is attached to the outside of the tube wall of the cannula tube. In an alternative embodiment, the speech air supply is formed at least in sections by a tube made of the film that is attached to the outside of the tube wall of the cannula tube. While in the first-mentioned alternative the lumen of the second air line is defined on one side by the layer of film and on the other side by the outside of the tube wall of the cannula tube, in the last-mentioned alternative the lumen of the speech air supply is defined exclusively by the tube made of film.

[0034] In certain embodiments, the film or tube has a preformed geometry with a smaller cross-section, whereby the full cross-section only develops when the speech air flows through the lumen. Without speech air flow, the film or tube returns to the cross-section of the preformed geometry. The preformed geometry can, for example, define one or more longitudinal indentations, for example, through different wall thicknesses of the film.

[0035] In certain designs, the film layer or film tube is attached to the outside of the tube wall of the cannula tube by gluing or welding.

[0036] Applying a layer of film to the outside of the cannula tube wall has the advantage that relatively little film material is required. Furthermore, this typically results in a crescent-shaped cross-section of the lumen of the second air line, allowing for a lumen with relatively little radial bulk.

[0037] The attachment of the second air line in the form of a tube made of the film has the advantage that such a tube in itself provides great reliability in terms of tightness, whereas in the case of attaching a layer of the film on the outside of the cannula wall, the connection must be airtight in order to achieve the required tightness.

[0038] For commercially available channels for subglottic suction, such a flexible design as described here would not be effective, as a soft suction channel would collapse when the vacuum required for suction is applied. Since effective suction would not be possible in a collapsed state, the channels for subglottic suction must necessarily be designed to be quite inflexible. This often leads to pressure sores.

[0039] In certain embodiments, the geometry of the second air line is selected such that at a speech air volume flow of 5 l / min, the hydraulic diameter of the second air line is at least 2.5 mm at an ambient pressure of 1000 mbar.

[0040] The hydraulic diameter of the air outlet should be dimensioned so that, on the one hand, with an air flow of 5 l / min through this opening in the cuff, sufficient pressure builds up so that the cuff conforms to the stoma wall to create an adequate seal. On the other hand, the pressure should not be so great that this seal is perceived as painful for the patient. Ideally, the contact pressure on the tissue should not be greater than 40 mbar. Since the maximum pressure only occurs for the short time that the speaking air is supplied, the risk of pressure sores from the second air line is almost eliminated. Depending on the design, the cross-section of the air outlet is in the range of 1 to 4.5 mm2.

[0041] In some embodiments, the material of the second cuff has a particularly high tear strength and is tear-resistant at least up to a speech air pressure of 200 mbar. More preferably, the second cuff is tear-resistant up to a speech air pressure of 500 mbar.

[0042] The tear strength and also the variability of the lumen of the second cuff are influenced partly by the layer thickness (wall thickness) of the cuff material and partly by the properties of the material from which the cuff is made. In certain embodiments of the invention, the cuff material consists of a film with a wall thickness in the range of 5 to 300 µm. In some embodiments, the wall thickness of the material of the second cuff is at least 10 µm, at least 20 µm, or at least 30 µm. Preferably, in certain embodiments, the wall thickness is at most 250 µm or at most 200 µm.

[0043] In certain embodiments, the material of the second cuff preferably has an elongation at break (according to DIN EN ISO 527) in the range of 150-600%.

[0044] In certain embodiments, the second inflatable cuff is made of a thermoplastic polymer having a Shore A in the range of 5 to 90.

[0045] In certain embodiments, the second inflatable cuff is made of a thermoplastic polymer selected from PVC or polyurethane. Other plastic polymers suitable for the second inflatable cuff include PE, PP, EVA, PEBAX, and silicone.

[0046] A polymer such as silicone, which has a relatively high permeability to air, can also be used as a cuff material without any problems, since the air pressure is newly formed during each speech phase.

[0047] In certain embodiments, the ventilation device according to the invention additionally has a separate suction line for suctioning subglottic secretion.

[0048] In embodiments where a separate suction line is provided for suctioning subglottic secretions, this can either be incorporated into the wall of the tracheostomy tube or attached to the outside of the tube wall. In the latter case, the film of the second air line runs on top of the suction line, laterally next to the suction line. In an alternative embodiment, the film of the second air line spans the suction line longitudinally, at least in sections.

[0049] Preferably, the air outlet of the second air line is positioned proximally at a distance of at least 2 mm from the secretion inlet of the suction line. This minimum distance ensures that the air does not have to flow through a residual amount of secretion during speech. This would impair speech quality and also have hygienic disadvantages, as aerosols could form.

[0050] In certain embodiments of the invention, a connector for connecting to a compressed air source, such as a Y-piece or a connector, is provided at the proximal end of the second air line. In certain embodiments, the connector has a valve, a regulator, and / or an opening that can be closed with a finger (=fingertip connector). This can be used to control when and, if necessary, how much compressed air flows into the subglottic area via the second air line.

[0051] Certain embodiments of the invention are characterized in that the second air line in the region of the extracorporeal section consists of a flexible plastic tube which has a greater hardness and / or wall thickness than the film from which the speech air supply is made, at least in sections, in the stoma section and / or tracheal section.

[0052] In certain embodiments of the invention, the second air line additionally has a valve at the air outlet at its distal end. According to the invention, this valve should be configured to allow air to escape into the subglottic area while preventing air from entering the second air line from the subglottic area. The valve function makes it possible to generate negative pressure in the second air line in order to selectively reduce the cross-section of the lumen of the second air line by applying negative pressure, if necessary. The cuff located in the stoma then conforms to the cannula tube of the tracheostomy tube.

[0053] In certain embodiments, the valve function is provided by a flap valve. In alternative embodiments, the valve function is provided by the last section of the air outlet being designed with significantly thinner walls than the remaining sections of the second air line, so that this section closes when a negative pressure is applied. The length of the particularly thin-walled section of the air outlet is preferably 0.3-1 cm or more.

[0054] For the purposes of original disclosure, it is pointed out that all features as they become apparent to a person skilled in the art from the present description, the appended drawings, and the claims, even if they were specifically described only in conjunction with certain other features, can be combined both individually and in any combination with other features or groups of features disclosed herein, unless this has been expressly excluded or technical circumstances make such combinations impossible or pointless. A comprehensive, explicit presentation of all conceivable combinations of features is omitted here solely for the sake of brevity and readability of the description.

[0055] The attached figures and the associated description schematically illustrate specific embodiments of the invention. These specific embodiments are merely examples of possible combinations of features. However, the invention is by no means limited to these specific embodiments, but encompasses all embodiments covered by the scope of the patent claims, even if they are not explicitly illustrated or described. Figure 1:The figures a) and b) of Figure 1 represent schematic cross-sections through the cannula tube in the stoma section of an embodiment of a ventilation device according to the invention, in which the speech air line is realized in the form of a channel running in the tube wall of the cannula tube, wherein the cross-section in Figure b) is located at the level of an additional air outlet into the lumen of the first cuff. Figure 2: Figures a) and b) of Figure 1represent schematic cross-sections through the cannula tube in the stoma section of an embodiment of a ventilation device according to the invention, in which the speech air line is realized in the form of a film layer arranged on the outside of the cannula tube, wherein the cross-section in Figure b) is located at the level of an additional air outlet into the lumen of the first cuff. Figure 3: Figures a) and b) of Figure 1 represent schematic cross-sections through the cannula tube in the stoma section of an embodiment of a ventilation device according to the invention, in which the speech air line is realized in the form of a film layer arranged on the inside of the cannula tube, with the cross-section in figure b) being located at the level of an additional air outlet into the lumen of the first cuff. Figure 4: Figure 4shows a perspective view of an embodiment of a ventilation device according to the invention, in which the speech air line in the stoma section and in the tracheal section is provided in the form of a channel in the tube wall of the cannula tube, with figure a) showing the state with the stoma cuff not mounted and figure b) showing the state with the stoma cuff mounted. Figure 5: Figure 5 shows a side view of the Figure 4 b) Perspective view of an embodiment of the ventilation device according to the invention. Figure 6: Figure 6 shows a schematic longitudinal sectional view of an embodiment of a ventilation device according to the invention, in which the speech air line runs in the stoma section and in the tracheal section on the inside of the tube wall of the cannula tube. Figure 7: Figure 7shows a schematic longitudinal sectional view of an embodiment of a ventilation device according to the invention, in which the speech air line runs in the stoma section and in the tracheal section on the outside of the tube wall of the cannula tube. Figure 8: Figure 8 shows perspective views of an embodiment of a ventilation device according to the invention, in which the speaking air line in the stoma section and in the tracheal section is provided in the form of a film layer attached to the outer wall of the cannula tube, wherein figure a) shows the state without a mounted film cuff and figure b) shows the state with a mounted film cuff.

[0056] Figure 1shows a schematic cross-section through the stoma section of the cannula tube of an embodiment of a ventilation device according to the invention. The tube wall 3 of the cannula tube defines a cannula tube interior in this area through which the respiratory air can flow. In the upper area of ​​the cross-section shown here, a speech air line in the form of a channel 12 embedded in the tube wall 3 is provided. Speech air, which is provided by an extracorporeal speech air source, can be guided distally through this channel 12 in order to introduce it into the trachea. In the embodiment shown here, the cuff air line 8 runs in the tube wall 3. Figure a) shows a cross-section through the channel 12 in which it is closed.Figure b) shows a cross-section through the section of the channel 12 in which it has an air outlet 15 which opens into the lumen of the inflatable cuff 14 provided in the stoma section on the outside of the tube wall 3 in a ring shape around the cannula tube.

[0057] Figure 2shows a schematic cross-section through the stoma section of the cannula tube of a further embodiment of a ventilation device according to the invention. The tube wall 3 of the cannula tube here defines a circular cannula tube interior through which the breathing air can flow. On the outside of the cannula tube, on the tube wall 3, the speech air line is provided in the form of a plastic layer, which in the state shown here defines an essentially crescent-shaped lumen. In the embodiment shown here, the cuff air line 8 runs in the tube wall 3. Figure a) shows the cross-section through a section in the stoma area in which the plastic layer 11 is continuous. Figure b) shows a cross-section through an area in which an air outlet 15 is provided in the plastic layer 11, which opens into the lumen of the inflatable cuff 14 arranged annularly around the cannula tube in the stoma section of this embodiment.

[0058] Figure 3 shows a schematic cross-section through the stoma section of another embodiment, in which a film layer 11 is provided on the inside of the tube wall 3. In this embodiment, an air outlet 15 is provided in the tube wall 3 in a region of the stoma section, which opens into the lumen of the annular inflatable cuff 14 arranged in this region. Here, too, the cuff air line 8 runs in the tube wall 3.

[0059] In Figure 41 shows an embodiment of the invention with a speech air line running in the tube wall in the form of a channel. In the stoma section of the cannula tube 2, two air outlets 15, 16 are provided in the tube wall, which open into the lumen of an annular cuff arranged above it. In figure a), the cuff 14 is shown separately in the unassembled state so that the air outlets 15, 16 can be clearly seen. In figure b), the ventilation device is then shown with the cuff 14 assembled, which then covers the air outlets 15, 16. Also visible in both figures is the air outlet 10, which is provided in the tube wall 2 starting from the two air outlets 15, 16 in a distal direction. The speech air provided by the speech air line 9 can be introduced into the trachea via this air outlet 10 and used by the patient for phonation.In addition to the cuff 14 arranged in the stoma section, the tracheal cuff 7 for sealing the trachea can also be seen here, as well as the cannula shield 19, which holds the cannula tube 2. The cuff air line is not visible in these images.

[0060] In Figure 5 is the embodiment of Figure 4shown again in a side view. Here, the transition of the extracorporeal section of the speech air line 9 into the cannula tube 2, just before the cannula shield 19, is clearly visible. Also marked here are the proximal breathing air opening 20 of the cannula tube 2 and the distal breathing air opening 21, through which the breathing air can flow in and out of the lumen of the cannula tube 2. The speech air line 9 has a connector 17 at its proximal end, via which the connection to a compressed air source can be established. By covering or uncovering the valve opening 18, the patient can control whether a continuously supplied stream of compressed air flows through the extracorporeal section of the speech air line 9 or takes the path of least resistance through the valve opening 18. This illustration also shows the cuff air line 8 with control balloon 13.

[0061] Figure 6shows a schematic longitudinal sectional view of an embodiment of a ventilation device 1 according to the invention, in which the speech air line 9 runs in the stoma section 5 and in the tracheal section 6 on the inside of the tube wall 3 of the cannula tube 2. Also clearly visible here are the two air outlets 15, 16, through which speech air can flow into the lumen of the cuff 14, as well as the air outlet 10, through which the speech air can be introduced into the trachea. This illustration also shows the cuff air line 8 with control balloon 13.

[0062] In Figure 7A schematic longitudinal sectional view of an embodiment of a ventilation device 1 according to the invention is shown, in which the speech air line 9 runs in the stoma section and in the tracheal section on the outside of the tube wall of the cannula tube 2. The air outlets 15 and 16 in the stoma section and the air outlet 10 in the tracheal section are clearly visible here. The cuff air line 8 with control balloon 13 can also be seen here.

[0063] In Figure 81 shows an embodiment of the ventilation device according to the invention in which the speech air line is provided in the form of a plastic layer 11 applied to the outside of the cannula tube 2. The plastic layer 11 extends as far as the air outlet 10 in the tracheal section. In addition to the air outlet 10, the plastic layer 11 in the stoma section has a further air outlet 15 which opens into the lumen of the annular cuff 14 which is arranged around the cannula tube 2 and simultaneously also encloses the plastic layer 11 of the speech air line in the stoma section. If speech air flows through the speech air line 9 and reaches the lumen in the stoma section which extends between the plastic layer 11 and the outside of the tube wall of the cannula tube 2, a portion of the speech air can reach the lumen of the cuff 14 via the additional air outlet 15 in the stoma section, thereby inflating the cuff 14.In this way, the air flow during speech can temporarily seal the stoma during speech. Figure b) of . Figure 8 The state in which the cuff 14 is mounted around the cannula tube 2 is shown. For illustrative purposes, the cuff is shown separately, i.e., in the unmounted state, in Figure a). This shows the air outlet 15, which opens into the lumen of the cuff 14 when it is mounted. Reference symbol

[0064] 1 Ventilation device 2 Cannula tube 3 Tube wall 4 Extracorporeal section 5 Stoma section 6 Tracheal section 7 First cuff (tracheal cuff) 8 First air line (cuff air line) 9 Second air line (speech air line) 10 Air outlet 11 Position 12 Channel 13 Control balloon 14 Second cuff (stoma cuff) 15 Air outlet 16 Air outlet 17 Connector 18 Valve 19 Cannula shield 20 Proximal air opening 21 Distal air opening

Claims

1. Ventilation device (1), in particular a tracheostomy cannula, having ▪ a cannula tube (2), of which the tube wall (3) has an extracorporeal portion (4), has a stoma portion (5) and has a tracheal portion (6), ▪ a first inflatable sleeve (7), which extends annularly around the cannula tube (2), on the outer side of the tube wall (3), in the tracheal portion (6), ▪ a first air line (8), which has an air outlet into the lumen of the first sleeve (7), ▪ a second inflatable sleeve (14), which extends annularly around the cannula tube (2), on the outer side of the tube wall (3), in the stoma portion (5), and ▪ a second air line (9), which has an air outlet (10) in the region between stoma portion (5) and first sleeve (7), characterized in that the second air line (9) has in the region of the stoma portion (5) an additional air outlet (15) into the lumen of the second sleeve.

2. Device according to Claim 1, characterized in that the second air line (9) is purely a voice-air line, through which only voice air is guided.

3. Device according to Claim 1, characterized in that the second air line (9) is a subglottic suction-extraction line, through which subglottic secretions can be extracted by suction in one direction and through which voice air can be guided in the other direction.

4. Device according to one of the preceding claims, characterized in that the second air line (9) runs in the tube wall (3) of the cannula tube (2) or on the outer side of the tube wall (3) of the cannula tube (2) or on the inner side of the tube wall (3) of the cannula tube (2) .

5. Device according to one of the preceding claims, characterized in that the second inflatable sleeve consists of a thermoplastic polymer with a Shore A in the range from 5 to 90.

6. Device according to one of the preceding claims, characterized in that the second inflatable sleeve consists of a plastic polymer which is selected from silicone, PVC and polyurethane.

7. Device according to one of the preceding claims, characterized in that, with an air flow passed through the second air line of 5 litres per minute, the second inflatable sleeve has an outer diameter which is at least 20% greater than the outer diameter of the cannula tube at the level of the sleeve.

8. Device according to one of the preceding claims, characterized in that the second inflatable sleeve is tear-resistant at least up to a voice-air pressure of 200 mbar.

9. Device according to one of the preceding claims, characterized in that the second inflatable sleeve is formed by a film with a wall thickness in the range from 5 to 100 µm.

10. Device according to one of the preceding claims, characterized in that said device additionally has a separate suction-extraction line (16) for extracting subglottic secretions by suction.

11. Device according to one of the preceding claims, characterized in that the second air line has at the proximal end thereof a connector (17) for compressed air, preferably a fingertip connector.

12. Device according to one of the preceding claims, characterized in that, in the region of the extracorporeal portion, the second air line consists of a flexible plastic hose which has a greater hardness and / or wall thickness than the material of which the second air line consists in the stoma portion and / or tracheal portion.

13. Device according to one of the preceding claims, characterized in that the second air line has a valve (18) at the air outlet on the distal end thereof.