VENTILATION DEVICE WITH SPEAKING AIR SUPPLY

Description

[0001] The present invention relates to a ventilation device, in particular a tracheostomy cannula or an endotracheal tube, comprising a cannula tube, an inflatable cuff, a cuff air line and a speech air line having an air outlet in the area between the stoma and the cuff.

[0002] To ensure that the air flows almost completely through a tracheostomy tube or endotracheal 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 or endotracheal tube, preventing air from flowing 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] To enable voice production at least temporarily, the cuff can be temporarily released, if medically indicated. If the opening of the cannula is simultaneously closed, e.g., with a finger or a speaking valve, air can be used to produce voice during exhalation through the natural airways.

[0004] However, there are medical reasons why this method cannot be used for a significant proportion of patients. Ventilation with the cuff unlocked has significant disadvantages, particularly for patients who require sustained positive lung pressure. Even for patients who require a locked cuff due to dysphagia (difficulty swallowing), unlocking the cuff for speaking is often problematic due to the risk of aspiration.

[0005] EP 1 803 478 B1 describes a cannula that allows patients to speak despite the cuff being blocked. This is achieved by a special inner cannula that redirects the air during exhalation using windows in the outer cannula so that the exhaled air flows through the natural airways. However, this requires some compromises regarding the ventilation parameters on the ventilator, which are not always desirable. Therefore, methods that do not require any compromises in ventilation are preferred.

[0006] 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.

[0007] 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.

[0008] 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.

[0009] 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. The advantage of ACV via a subglottic suction channel is that by suctioning the secretion before introducing speech air, speech quality can be significantly improved in many patients.

[0010] However, the delivery of speech air via a subglottic suction channel has the disadvantage that any secretion remaining on the canal wall after suctioning dries due to the compressed air. The dried secretion adheres 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.

[0011] In addition to the benefits of phonation, ventilation of the upper airways also improves the removal of mucus and secretions from the upper airways. It also helps train the swallowing reflex. Thus, a separate air supply to the subglottic area is also beneficial when a patient is unwilling or unable to speak.

[0012] Furthermore, the following documents are known from the prior art, namely US 9 038 637 B2, DE 103 61 428 B3, DE 20 2004 018665 U1, US 10 173 021 B2 and EP 1 820 527 A1.

[0013] 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 or an endotracheal tube, comprising ▪ a cannula tube, the tube wall of which has an extracorporeal section, a stoma section and a tracheal section, ▪ an inflatable cuff which extends in a ring around the cannula tube in the tracheal section on the outside of the tube wall, ▪ a cuff air line which has an air outlet in the cuff, ▪ a speech air line which has an air outlet in the area between the stoma section and the cuff, characterized in that the speech air line in the region of the stoma section and / or the tracheal section is formed at least in sections by a film arranged on the outside of the cannula tube, which forms a variable lumen for the passage of speech air, wherein the variable lumen of a section n of the speech air line formed by the film has a cross section Q n at a speech air volume flow of 5 liters per minute and an ambient pressure of 1000 mbar, the cross section of the lumen of section n is reduced by at least 30% compared to the cross section Q n at an overpressure acting on the outside of the film of up to 15 mbar when no speech air flows through the speech air line.

[0014] When used as intended, the ventilation device according to the invention rests against the stoma of a patient in the area of ​​the stoma section. From this stoma section, the extracorporeal section extends in a proximal direction and the tracheal section in a distal direction.

[0015] 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.

[0016] 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.

[0017] At a speech air flow rate of 5 l / min, as typically occurs with ACV, the speech air duct in the trachea and possibly also in the stoma occupies a certain volume. If the speech air flow is interrupted, this volume is reduced even by the slightest pressure, whether due to an increase in ambient pressure or due to surrounding tissue.

[0018] The ventilation device proposed according to the invention has the advantage that the inner lumen required to pass sufficient speech air is formed when a suitable speech air volume flow actually flows through the speech air line. In particular, at a speech air volume flow of 5 l / min and an ambient pressure of 1000 mbar, the speech air line has a specific cross-section Q n , which decreases by at least 30% when an overpressure of up to 15 mbar acts on the outside of the foil as soon as the volume flow ceases.

[0019] This is achieved by forming the speech air line by means of a film arranged at least in sections on the outside of the cannula tube, which film defines a lumen which is variable under the above-mentioned conditions to the extent defined above.

[0020] For the purposes of the present invention, the term "ambient pressure" refers to the pressure acting on the film. For a ventilator that is not in use, that is not inserted into a stoma, and that does not carry any speech air through its air line, the ambient pressure corresponds to atmospheric pressure and acts equally on both the outward-facing and inward-facing sides of the film.

[0021] When speech air is passed through the speech air line, a correspondingly increased pressure acts on the inward-facing side of the foil, resulting in the foil having a specific cross-section Q n in a defined section n. If the pressure acting on the foil from the outside increases, this increased pressure counteracts the increased pressure caused by the speech air, which acts on the inward-facing side of the foil.

[0022] The increase in pressure acting on the film from the outside can be caused either by surrounding tissue or by an increase in the air pressure acting on the film of the air duct from the outside.

[0023] In the context of the present invention, the term "cross-section" refers to the area of ​​a cross section through the inner lumen of the speech air line perpendicular to the main flow direction. The cross section Qn of the lumen of the speech air line according to the invention is equal to the area of ​​the cross section through the inner lumen in a section n of the speech air line formed by the film at a speech air flow rate of 5 l / min and an ambient pressure of 1000 mbar.

[0024] Typically, the cross-section Q n of the lumen of the speech air line section formed by the film according to the invention is in the range from 1 to 50 mm 2 . In other embodiments, the cross-section Q n is in the range from 10 to 40 mm 2 . In certain embodiments, the cross-section Q n of the lumen of the speech air line section formed by the film according to the invention is in the range from 1 to 25 mm 2 . In other embodiments, the cross-section Q n is in the range from 10 to 25 mm 2 .

[0025] In certain embodiments of the invention, the cross-section of the lumen of section n is reduced by a maximum of 10% compared to the cross-section Q n at an overpressure of up to 15 mbar acting on the outside of the film when speech air flows through the speech air line at a speech air volume flow of 5 liters per minute. If no more speech air flows through the speech air line, the cross-section of the lumen of section n is reduced by at least 30% at an overpressure of up to 15 mbar acting on the outside of the film.

[0026] Preferably, the section of the speech air line formed by the film extends in the proximal-distal direction over at least 50%, at least 60%, at least 70%, at least 80%, at least 90% or 100% of the length of the stoma section.

[0027] Preferably, the section of the speech air line formed by the film 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 section between the stoma section and the cuff.

[0028] The speaking air is typically provided by a compressed air device that can deliver a speaking air volume flow of at least 5 l / min through the lumen of the speaking air line. The speaking air volume flow is the volume that flows through the speaking 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, Q n is achieved by stretching the film, which occurs at a speech air volume flow of 5 l / min and an ambient pressure of 1000 mbar. The reduction of Q n due to increased ambient pressure or reduced volume flow occurs in these embodiments because the stretching of the film decreases again due to its elasticity. In other embodiments, Q n is achieved by the speech air stretching the film 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 film, without the film being stretched. The reduction of Q n due to increased ambient pressure or reduced volume flow occurs in these embodiments because the film collapses at least partially.In special embodiments, Q n is achieved partly by stretching the film and partly by stretching the film by a speaking air volume flow of 5 l / min at an ambient pressure of 1000 mbar.

[0030] The variability of the lumen of a section of the speech air line formed by the foil under different pressure conditions can be measured in a materials testing machine for compressive force. During this time, the pressure drop during flow through the line can be measured. Changes in the lumen are then clearly noticeable through a change in the pressure drop.

[0031] 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 speech 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.

[0032] 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.

[0033] 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.

[0034] Applying a layer of foil to the outside of the tube wall of the cannula tube has the advantage that relatively little foil material is required. Secondly, this typically results in a crescent-shaped cross-section of the lumen of the speech air line, allowing for a lumen that has a relatively low radial bulk.

[0035] The attachment of the speech air line in the form of a tube made of foil 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 foil on the outside of the cannula wall, the connection must be airtight in order to achieve the required tightness.

[0036] 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.

[0037] To ensure that the air supplied via the speech air line according to the invention escapes through the natural airways as intended, thus enabling ACV, an embodiment of the invention is proposed in which the speech air line in the stoma section is formed at least in sections by an inflatable cuff made of the film, which extends in a ring around the cannula tube and has at least one air outlet towards the tracheal section. This inflatable cuff, when flowed through by speech air, can seal any gap that may exist between the tracheostomy cannula and the stoma tissue. It has been shown that, particularly in patients with a large stoma, the quality of voice production can be significantly improved by appropriate sealing.Patients who require a permanent tracheostomy tube often have a stoma so large that the gap between the stoma and the tracheostomy tube prevents sufficient pressure from being built up for speech. For these patients, a sufficient seal of the stoma is essential for any form of speech.

[0038] In a preferred variant of the above-described embodiment with an inflatable cuff, the cuff, when exposed to an air flow of 5 l / min in a free state outside a patient, has an outer diameter that is at least 20% larger than the outer diameter of the cannula tube at the level of the cuff. In certain embodiments of the invention, the inflatable cuff, when exposed to an air flow of 5 l / min, has an outer diameter that is at least 30%, at least 40%, or even at least 50% larger than the outer diameter of the cannula tube at the level of the cuff.

[0039] In a further alternative embodiment of the invention, the speech air line is formed both in the stoma section and in the tracheal section by a layer or a tube made of the film, wherein in the stoma section, on the outside of the tube wall of the cannula tube, a film with the properties according to the invention is additionally attached, resulting in an inflatable cuff that extends in a ring around the cannula tube and over the layer or tube of the speech air line, wherein the layer or tube has an air outlet into the lumen of the cuff in the area running through the inflatable cuff. If speech air flows through the speech air line formed by the layer or tube, the cuff surrounding it also inflates, since the speech air flows into the lumen of the cuff via the air outlet provided in the layer or tube in the area of ​​the cuff.

[0040] In an embodiment of the invention in which the film material does not expand significantly but clings to the stoma wall by means of folds, the outer diameter of the cuff in the fully inflated free state should be at least 20%, preferably at least 30%, at least 40% or at least 50% larger than the outer diameter of the cannula tube.

[0041] In certain embodiments, the geometry of the speech air line is selected such that at a speech air volume flow of 5 l / min, the hydraulic diameter of the speech air line is at least 2.5 mm at an ambient pressure of 1000 mbar.

[0042] The hydraulic diameter of the air outlet should be dimensioned so that, with an air flow of 5 l / min through this opening in the cuff, sufficient pressure builds up so that the air channel conforms to the stoma wall, creating a sufficient seal. At the same time, the pressure should not be so great that this seal is perceived as painful by the patient. Preferably, the contact pressure on the tissue should not exceed 40 mbar. Since the maximum pressure only occurs for the short time during the speech air supply, the risk of pressure sores from the speech air line is virtually eliminated.

[0043] Depending on the design, the cross-section of the air outlet at the distal end of the speech air line has a cross-section that differs from the cross-section of the rest of the speech air line and ranges from 1 to 4.5 mm2.

[0044] In some embodiments, the film of the speech air line has a particularly high tear resistance and is tear-resistant at least up to a speech air pressure of 200 mbar. Even more preferably, the speech air line is tear-resistant up to a speech air pressure of 500 mbar.

[0045] The tear strength and variability of the lumen of the air line are influenced partly by the film thickness (wall thickness) and partly by the material from which the film is made. In certain embodiments of the invention, the wall thickness of the air line's film is 5 to 300 µm. The thinner the film material, the more susceptible it is to damage, such as cracks. Thicker film material, in turn, adds more bulk and is therefore disadvantageous. Therefore, a careful consideration of which criterion should be weighted and how.

[0046] In certain embodiments, the wall thickness of the foil of the speech air line 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.

[0047] In certain embodiments of the invention, the film of the speech air line consists of a plastic polymer material selected from polyurethane, soft PVC, PE, PP, EVA, PEBAX, silicone.

[0048] In certain embodiments, the film of the speech air line preferably has an elongation at break (according to DIN EN ISO 527) in the range of 150-600%.

[0049] In certain embodiments, the speech air line, at least in the stoma area, consists of a plastic polymer with a Shore A in the range of 5-90.

[0050] In certain embodiments, the ventilation device according to the invention additionally has a separate suction line for suctioning subglottic secretion.

[0051] 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 foil of the speech air line runs on top of the suction line, laterally next to the suction line. In an alternative embodiment, the foil of the speech air line spans the suction line longitudinally, at least in sections.

[0052] Preferably, the air outlet of the speech 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 required for speech does not have to flow through a residual amount of secretion. This would impair speech quality and also have hygienic disadvantages, as aerosols could form.

[0053] 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 speech 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 speech air line.

[0054] Certain embodiments of the invention are characterized in that the speech 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.

[0055] In certain embodiments of the invention, the speech 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 speech air line from the subglottic area. The valve function makes it possible to generate negative pressure in the speech air line in order to selectively reduce the cross-section of the lumen of the speech air line by applying negative pressure, if necessary.

[0056] 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 speech 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.

[0057] 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.

[0058] 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 a schematic cross-section through the cannula tube in the tracheal 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 in Figure a) the state with a speech air volume flow of 5 l / min at normal ambient pressure is shown. Figure 2: Figures a) and b) of Figure 2 represent a schematic cross-section through the cannula tube in the tracheal 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 tube arranged on the outside of the cannula tube, wherein in figure a) the state with a speech air volume flow of 5 l / min at normal ambient pressure is shown. Figure 3: Figures a) and b) of Figure 3 depicts a schematic cross-section through the cannula tube in the tracheal 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 pre-tensioned foil layer arranged on the outside of the cannula tube, with the state at a speech air flow rate of 5 l / min at normal ambient pressure being shown in Figure 4: Figure 4shows a side view of an embodiment of a ventilation device according to the invention, in which the speech air line in the stoma section and the tracheal section is provided in the form of a foil tube. Figure 5: Figure 5 shows 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 the tracheal section is provided in the form of a foil tube. Figure 6: Figure 6 shows 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 the tracheal section is provided in the form of a film layer. Figure 7: Illustration a) of Figure 7shows 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 the tracheal section is provided in the form of a foil cuff. Figure b) of Figure 7 shows the separate foil sleeve before it was attached to the cannula tube. Figure 8: Figure 8 shows 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 from a combination of a film layer and a film cuff, wherein figure a) shows the state without the film cuff mounted and figure b) shows the state with the film cuff mounted. Figure 9: Figure 9 an embodiment of a ventilation device according to the invention is shown, which in addition to the speech air line also has a subglottic suction line.

[0059] Figure 1shows a schematic cross-section through the cannula tube 2 of an embodiment of a ventilation device according to the invention in the tracheal section. The tube wall 3 of the cannula tube defines a circular cannula tube interior in this area through which the breathing air can flow. On the outside of the cannula tube 2, a flexible plastic film layer 11 is arranged on the tube wall 3, which defines a lumen with a cross-section Q at a speech air volume of 5 l / min in the section shown here (Figure a)). The cuff air line 8 runs in the tube wall 3 in the embodiment shown here. Figure b) shows the state in which no more speech air is conducted through the speech air line, whereby the cross-section of the lumen between the film layer 11 and the outside of the tube wall 3 is reduced by over 50%.

[0060] Figure 2shows a schematic cross-section through the cannula tube 2 of an embodiment of a ventilation device according to the invention in the tracheal section. The tube wall 3 of the cannula tube defines a circular cannula tube interior in this area through which the breathing air can flow. On the outside of the cannula tube 2, on the tube wall 3, a flexible film tube 12 is arranged, which defines a lumen with a cross-section Q at a speaking air volume of 5 l / min in the section shown here (Figure a)). The cuff air line 8 runs in the tube wall 3 in the embodiment shown here. Figure b) shows the state in which no more speaking air is conducted through the speaking air line, whereby the cross-section of the lumen between the film tube 12 and the outside of the tube wall 3 is reduced by over 50%.

[0061] Figure 3shows a schematic cross-section through the cannula tube 2 of an embodiment of a ventilation device according to the invention in the tracheal section. The tube wall 3 of the cannula tube defines a circular cannula tube interior in this area through which the breathing air can flow. On the outside of the cannula tube 2, on the tube wall 3, a flexible film tube 12 is arranged, which defines a lumen with a cross-section Q at a speaking air volume of 5 l / min in the section shown here (Figure a)). The cuff air line 8 runs in the tube wall 3 in the embodiment shown here. Figure b) shows the state in which no more speaking air is conducted through the speaking air line, whereby the cross-section of the lumen between the film tube 12 and the outside of the tube wall 3 is reduced by over 30%.

[0062] In the plan view from the side of an embodiment of the ventilation device according to the invention, which in Figure 4 As shown, it can be seen that the extracorporeal section 4 is the area that extends from the cannula shield 19 in the proximal direction to the proximal end of the cannula. In the distal direction, the cannula shield 19 is first adjoined by the stoma section 5, directly followed by the tracheal section 6. The stoma section 5 is a standardized area that is slightly longer (adults) or slightly shorter (children) depending on the patient's size and neck diameter. The length of the tracheal section 6, which directly adjoins the stoma section 5 in the distal direction, also varies accordingly.

[0063] The Figure 4The ventilation device 1 shown has, in addition to the speaking air line 9, a cuff air line 8. The cuff air line 8 has a control balloon 22 at its proximal end, and in the stoma and tracheal section, the cuff air line 8 runs on the underside of the cannula tube 2 to the cuff 7, into which the cuff air line 8 opens with an air outlet (not shown). The cannula tube 2 has a proximal breathing air opening 20 and a distal breathing air opening 21, through which the breathing air can flow into and out of the lumen of the cannula tube 2. The speaking air line 9 has a connector 17 at its proximal end, via which the connection to a compressed air source can be established.By opening 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. The speech air guided through the extracorporeal section of the speech air line 9 enters in a distal direction behind the cannula shield 19 into the stoma section 5 of the speech air line 9 and then into the tracheal section 6 of the speech air line 9. In the tracheal section 6, the speech air line 9 finally opens into an air outlet 10 in an area between the stoma section and the cuff. In the stoma section 5 and in the tracheal section 10, the speech air line 9 is provided in the form of a film tube 12 attached to the top of the cannula tube 2.

[0064] In Figure 5 is the embodiment of Figure 4shown again in a perspective view. Here, the transition of the extracorporeal section of the speech air line 9 into the foil tube 12 is clearly visible. This transition takes place behind the ring holder 19 at the point where the stoma section of the cannula tube connects to the extracorporeal section of the cannula tube (cf. Figure 4 The extracorporeal section of the speech air line 9 is made of a more stable tubing material than the foil tubing 12 provided in the intracorporeal section. This is due in particular to the fact that outside the body, greater mechanical stresses can act on the speech air line 9, which it must therefore withstand.

[0065] In Figure 6An embodiment of the ventilation device according to the invention is shown, in which the speech air line in the stoma section and in the extracorporeal section is provided in the form of a film layer 11, which has an air outlet 10 in the tracheal section. The film layer is applied to the cannula tube 2 in such a way that, in the operation shown here with a speech air volume flow of 5 l / min, a tunnel-shaped lumen is formed.

[0066] In Figure 7A special embodiment of a ventilation device according to the invention is shown, in which the speaking air line 9 is provided in the stoma section in the form of a film cuff 13. The film cuff 13 has an air outlet 10 in the distal direction, which in the embodiment shown here extends some distance into the tracheal section. Figure a) shows the assembled state, in which the cuff 13 is arranged in a ring around the cannula tube 2. Figure b) shows the annular cuff 13 with the air outlet arranged thereon separately, i.e. in the unassembled state.

[0067] In Figure 8A further special embodiment of the ventilation device according to the invention is shown, in which the speech air line is provided in the form of a film layer 11 applied to the outside of the cannula tube. This film layer 11 extends to the air outlet 10 in the tracheal section. In addition to the air outlet 10 in the tracheal section, the film layer 11 in the stoma section has a further air outlet 15, which opens into the lumen of an annular cuff 14 arranged around the cannula tube 2 and simultaneously encloses the film layer 11 of the speech air line in the stoma section.If speech air flows through the speech air line 9 and enters the lumen in the stoma section that stretches between the film layer 11 and the outer wall of the cannula tube 2, a portion of the speech air can enter the lumen of the additional cuff 14 via the additional air outlet 15 in the stoma section of the film tube 11, thereby inflating the cuff 14. In this way, the speech air volume flow can temporarily seal the stoma during the speech process.

[0068] In figure b) of Figure 8 The state is shown in which the additional cuff 14 is mounted in a ring around the cannula tube 2 and the foil layer 11 of the speech air line 9. In Figure a), the additional cuff 14 is shown so that the additional air outlet 15 in the foil tube 11 can be seen.

[0069] In Figure 91 shows an embodiment of a ventilation device according to the invention in which, in addition to the cuff air line 8 and the speech air line 9, a suction line 16 for subglottic secretion is provided. The suction line 16 runs from the stoma section in the distal direction essentially parallel to and next to the film layer 11 of the speech air line 9 into the tracheal section. In the tracheal section, however, the suction line 16 extends somewhat further than the film layer 11 of the speech air line 9. The secretion inlet into the suction line 16 should be positioned as close to the cuff as possible so that as much secretion as possible is suctioned out. In the event that some secretion is nevertheless present above the cuff, the air outlet of the speech air line 11 should be offset somewhat more proximally. This is intended to ensure that the air for speaking is not passed through any secretion residue that may still be present after suction.This would impair speech quality and would also have hygienic disadvantages. Since considerable negative pressure must be created during suction, the suction line 16 is made of a much more stable hose material than the foil hose 11 of the speech air line 9. Reference symbol

[0070] 1 Ventilation device 2 Cannula tube 3 Tube wall 4 Extracorporeal section 5 Stoma section 6 Tracheal section 7 Cuff 8 Cuff air line 9 Speech air line 10 Air outlet 11 Position 12 Tube 13, 14 Cuff 15 Air outlet 16 Suction line 17 Connector 18 Valve 19 Cannula shield 20 Proximal air opening 21 Distal air opening 22 Control balloon

Claims

1. Ventilation device (1), in particular a tracheostomy cannula or an endotracheal tube, comprising • a cannula tube (2), of which a tube wall (3) has an extracorporeal portion (4), a stoma portion (5) and a tracheal portion (6), • an inflatable cuff (7), which extends in the tracheal portion (6) annularly about the cannula tube (2), on the outer side of the tube wall (3), • a cuff air line (8), which has an air outlet in the cuff, • a voice air line (9), which has an air outlet (10) in the region between stoma portion (5) and cuff (7), characterized in that the voice air line (9), in the region of the stoma portion (5) and / or of the tracheal portion (6), is formed at least in part by a film (11, 12, 13, 14) arranged on the outer side of the cannula tube (2), which film defines a variable lumen for the passage of voice air, wherein - the variable lumen of a portion n of the voice air line (9) formed by the film (11, 12, 13, 14) has, at a voice air volumetric flow of 5 litres per minute and at an ambient pressure of 1000 mbar, a cross section Qn, - with an overpressure of up to 15 mbar acting on the outer side of the film, the cross section of the lumen of the portion n is reduced by at least 30%, compared to the cross section Qn, when no voice air flows through the voice air line.

2. Device according to Claim 1, characterized in that the voice air line is formed at least in part by a layer (11) of the film which is arranged on the outer side of the tube wall of the cannula tube.

3. Device according to Claim 1, characterized in that the voice air line is formed at least in part by a hose (12) consisting of the film, which hose is arranged on the outer side of the tube wall of the cannula tube.

4. Device according to Claim 1, characterized in that the voice air line in the stoma portion is formed at least in part by an inflatable sleeve (13) consisting of the film, which sleeve extends annularly around the cannula tube and has at least one air outlet (10) in the direction of the tracheal portion.

5. Device according to Claim 4, characterized in that, with an air flow of 5 litres per minute passing through, the inflatable sleeve has an external diameter that is at least 20% greater than the external diameter of the cannula tube at the level of the sleeve.

6. Device according to one of Claims 1 to 3, characterized in that the voice air line is formed, both in the stoma portion and in part in the tracheal portion, by a layer or by a hose made of the film, wherein an additional inflatable sleeve (14) made of the film is provided in the stoma portion, on the outer side of the tube wall of the cannula tube, which additional inflatable sleeve extends annularly around the cannula tube and over the layer or the hose of the voice air line, wherein the layer or the hose in the region running through the inflatable sleeve has an additional air outlet (15) into the lumen of the sleeve.

7. Device according to one of Claims 1 to 6, characterized in that, with a voice air volumetric flow of 5 litres per minute, the hydraulic diameter of the voice air line is at least 2.5 mm at an ambient pressure of 1000 mbar.

8. Device according to one of Claims 1 to 7, characterized in that the film of the voice air line is resistant to tearing, at least up to a voice air pressure of 200 mbar.

9. Device according to one of Claims 1 to 8, characterized in that the film of the voice air line has a wall thickness in the range from 5 to 300 µm.

10. Device according to one of Claims 1 to 9, characterized in that the film of the voice air line consists, at least in the stoma region, of a plastic polymer with a Shore A in the range from 5 to 90.

11. Device according to one of Claims 1 to 10, characterized in that it additionally has a separate suction line (16) for aspiration of subglottic secretions.

12. Device according to Claim 11, characterized in that the suction line for the aspiration of subglottic secretions is fastened to the outer side of the tube wall of the cannula tube, wherein the film of the voice air line runs on the top of the suction line or laterally alongside the suction line or at least in part spans the suction line in the longitudinal direction.

13. Device according to one of Claims 1 to 12, characterized in that the voice air line has, at its proximal end, a connector (17) for compressed air, preferably a fingertip connector.

14. Device according to one of Claims 1 to 13, characterized in that the voice air line, in the region of the extracorporeal portion, consists of a flexible plastic hose which has a greater hardness and / or wall thickness than the film from which the voice air line is made, at least in part, in the stoma portion and / or tracheal portion.

15. Device according to one of Claims 1 to 14, characterized in that the voice air line has a valve (18) at the air outlet at its distal end.

16. Device according to one of Claims 1 to 15, characterized in that, with an overpressure of up to 15 mbar acting on the outer side of the film, the cross section of the lumen of the portion n is reduced by at most 10%, compared to the cross section Qn, when voice air flows through the voice air line at a voice air volumetric flow of 5 litres per minute.