Modified breathing tube for vacuum treatment of injuries or after surgery of the trachea

Abstract

The invention relates to a modified breathing tube (endotracheal tube and tracheostomy tube) for use in wound healing following injuries or surgery of the trachea. A modified breathing tube (endotracheal tube and tracheostomy tube) is described. Ventilation tube (1) for vacuum treatment of injuries or after surgery of the trachea, comprising: • a first cuff (2a) as an inflatable balloon at a first, upper end (20) of the breathing tube, with a first cuff tube (4a), • a second cuff (2b) as an inflatable balloon at a second, lower end (30) of the breathing tube, with a second cuff tube (4b), • a sponge (3) which is arranged between the two cuffs and surrounds the breathing tube, wherein both cuffs enclose the breathing tube in a ring shape, so that a vacuum area (6) extends between them in which a negative pressure can be created between the sponge and the tracheal wall, and wherein a film (3b) is provided in the vacuum region (6) which surrounds the sponge and thereby also encloses the breathing tube inside, wherein openings can be made through the film so that a negative pressure can be created in the vacuum region (6). wherein the foil (3b) completely encloses the sponge (3), and where >5 openings are present in the film (3b) and the openings are symmetrically distributed over the film surface, as well as a set made from it.

Description

[0001] The invention relates to a modified breathing tube for use in wound healing following injuries or surgery of the trachea. It is an endotracheal tube (for patients with normal airways) or a tracheostomy tube (for patients with a tracheostomy).

[0002] The so-called VAC therapy (also known as vacuum wound therapy or negative pressure wound therapy (NPWT)) is well-known. In this method, wounds are covered airtight with a special dressing made of sponge and film. A pump is connected to the dressing via a thin tube, which suctions away wound fluid. This creates negative pressure in the wound area to increase blood flow. Applying this suction to the wound improves wound healing. Exudate is drawn out, and granulation tissue forms.

[0003] Various devices from the prior art are known in this or other areas: WO 2013 / 181686A1 describes an endoluminal vacuum therapy device. This device provides, among other things, a means of applying negative pressure to a wound on an endoluminal surface of a patient to facilitate wound healing. The device comprises a flexible porous element with an outer surface defined between its opposing proximal and distal ends. A suction tube for connection to a suction source outside the patient's body is in fluid contact with the porous element to exert negative pressure on the wound via the outer surface of the porous element.

[0004] CN 1 03 826 689 A discloses non-invasive systems, devices and methods for selective cooling of the brain.

[0005] CN 1 10 064 111 A describes a visible bronchial cannula and its application. The invention relates to a bronchial cannula for performing lung ventilation in a patient. The bronchial cannula comprises a cannula body and a camera module, wherein the camera module is functionally attached to the front end of the cannula body to monitor relevant intraoperative information of the patient.

[0006] Various tracheal tubes are described in the standard DIN EN ISO 5361 2023-08-00.

[0007] US patent 2006 / 0150981A1 discloses a surface energy-assisted fluid transport system. This system utilizes surface energy to assist fluid transport or separation. An example is the removal of mucus from a patient's lungs during mechanical ventilation using an endotracheal tube.

[0008] There is no way to use VAC therapy in ventilated systems, such as the trachea.

[0009] Medical endotracheal tubes and tracheostomy tubes are available in various designs. However, none are suitable for VAC therapy on the trachea.

[0010] In other medical contexts, the following are described: For the treatment of COPD, US 8,491,602 B2 describes a surgical procedure for creating a pneumostoma. US 2020 / 306,476 A1 discloses a hydrogravity procedure for lung rehabilitation. WO 2015 / 168,387 A2 describes a procedure for treating hyperinflated lungs. A non-invasive system for cooling the brain by lavaging the upper airways is described in CN 103,826,689 A. It would not be applicable for VAC therapy in cases of tracheal injury.

[0011] Devices for VAC therapy, which are not suitable for ventilated systems such as tracheas, are described, for example, in WO 2011 / 116 691 A1, which provides for a “drainage container”.

[0012] The object of the invention is to provide a device that enables vacuum therapy (VAC therapy) for tracheal injuries. It should allow for gentle treatment. The risk of vocal cord or tracheal injury during use should be as low as possible. Manufacturing should be simple and inexpensive.

[0013] A change of the provided device as a solution to the task should only be necessary at long time intervals.

[0014] The problem is solved by the features of the independent claims. Preferred embodiments of the invention are described in dependent claims.

[0015] The invention relates to a modified breathing tube (as an endotracheal tube or as a tracheostomy tube) for vacuum treatment of tracheal injuries of the windpipe, comprising: • a first cuff as an inflatable balloon at a first, upper end of the breathing tube (for sealing at the top), with a first cuff tube, • a second cuff (for sealing at the bottom) as an inflatable balloon at a second, lower end of the breathing tube, with a second cuff tube, • a sponge which is positioned between the two cuffs (along the breathing tube) and surrounds this breathing tube, wherein both cuffs of the breathing tube enclose each other in a ring-like manner, so that a vacuum area extends between them in which (when used in a trachea) a negative pressure can be created between the sponge and the tracheal wall, and wherein a film is provided in the vacuum area that surrounds the sponge and thereby also encloses the breathing tube inside, whereby openings can be made through the film so that a negative pressure can be created in the vacuum area. the film completely encloses the sponge, and where >5 openings are present in the film and the openings are symmetrically distributed over the film surface. "Vacuum treatment" is synonymous with "VAC therapy." When the invention refers to a vacuum, it correctly means only a reduced pressure, as used in conventional vacuum therapies. “Ventilation tube” (here synonymous with “endotracheal tube” or “tracheostomy tube”) is the part of the invention through which the patentee breathes when using the invention - the air flows through the so-called main lumen.

[0016] Common endotracheal tubes have, for example, the following dimensions: - Length (measured along the so-called mid-arch, i.e., along the axis of rotation) depending on the treatment case: 16-35 cm, - Inner diameter (i.e., within the lumen): 0.2-1.1 cm (e.g., 0.2-0.3 cm for premature infants, or 0.7-0.9 cm for women, or 0.8-1.05 cm for men), - Outer diameter: 0.4-1.5 cm, - Material: PVC (polyvinyl chloride), silicone, PUR (polyurethane).

[0017] Common tracheostomy tubes have, for example, the following dimensions: - Length (measured along the so-called mid-arc, i.e., along the axis of rotation of the tube) depending on the treatment case: 3.0-13.5 cm, - Inner diameter (i.e., within the lumen): 0.2-1.1 cm (e.g., 0.2-0.3 cm for premature infants, or 0.7-0.9 cm for women, or 0.8-1.05 cm for men), - Outer diameter: 0.4-1.5 cm, - Material: PVC (polyvinyl chloride), silicone, PUR (polyurethane), or Ag (silver).

[0018] The breathing tube according to the invention (i.e., both an endotracheal tube and a tracheostomy tube) has a main part with a constant diameter, on which, in the case of the invention, the first and second cuffs are located.

[0019] A “cuff” within the meaning of the invention is an inflatable cuff / balloon for sealing upwards (i.e., the mouth or larynx) or downwards (i.e., the lower trachea / bronchi).

[0020] In the invention, the "cuffs" are able to seal the inventive breathing tube in such a way that a vacuum area can be formed between two cuffs and the inner wall of the trachea (when the invention is inserted into the trachea).

[0021] The “vacuum region” within the meaning of the invention is thus the region between the two cuffs, outside the outer wall of the main lumen.

[0022] The cuffs encircle the breathing tube in a ring-like fashion, sealing it when the breathing tube is inserted into the trachea, so that air can only flow through the breathing tube and no longer around the outside of the breathing tube. In the vacuum environment according to the invention, it is now possible to create a negative pressure between the outer wall of the breathing tube and the inner wall of the trachea using a vacuum hose.

[0023] The cuffs are attached to the breathing tube, for example, by adhesive. Welding and fusing are also possible.

[0024] "Upper" and "lower" refer to the orientation of the breathing tube according to the invention during use, that is, when inserted into the trachea and the patient is standing upright. In various embodiments of the breathing tube according to the invention, it is either an endotracheal tube or a tracheostomy tube. With the endotracheal tube, the upper end protrudes from the mouth, while with the tracheostomy tube, it protrudes from the neck just below the larynx. In both cases, the upper cuff should be positioned just below the vocal cords. The lower end, in both cases, lies in the lower trachea or the main bronchi.

[0025] The "first cuff tube" is connected to the first cuff. The "second cuff tube" is connected to the second cuff. Both cuff tubes run to their respective cuffs and allow the cuffs to be inflated to seal against the trachea. A control balloon may also be present at the outer end of each cuff tube to monitor the inflation process.

[0026] Only through the two cuffs with the cuff tubes according to the invention is it possible to create a vacuum zone in which the sponge can exert its effect. The cuff tubes run through the main lumen, that is, the interior of the breathing tube.

[0027] "Sponge" as used in the invention refers to any net-like (preferably hydrophobic) structure capable of allowing air to pass through (so that a vacuum can be created) and absorbing wound exudate. A thicker gauze is also possible, with a minimum thickness of 0.4 cm to allow a vacuum tube to be inserted inside the sponge to create negative pressure without exerting excessive pressure on the wound. The sponge thus also acts as a cushion.

[0028] It is therefore advisable to provide a vacuum hose that ends inside the sponge and with which air can be extracted.

[0029] Ideally, when using the sponge, it should be placed on the injury / wound and press down on the wound using vacuum / negative pressure, so that the advantages of the well-known VAC therapy can also be used in ventilated systems, such as the trachea.

[0030] The invention further relates to a set comprising such a breathing tube according to the invention and an insertion sleeve with an inner diameter at least 0.2 cm larger than the outer diameter of the breathing tube, so that it can be slipped over the breathing tube and thus inserted into the trachea; preferably at least 0.3 cm larger, or even at least 0.5 cm larger. The breathing tube can be inserted into the insertion sleeve and compressed (in particular, the sponge is also compressed), so that passage through the vocal cords is possible without injury.

[0031] In the case of a design with a (second) cannula and third cuff, as for example in Fig. As shown in Figure 3 and described further down in the document, the breathing tube 1 with the insertion sleeve attached would first be inserted into the trachea, and then the cannula 8 with the smaller inner diameter would be guided through the breathing tube and through the hole 9, as indicated. The third cuff would then also be inflated.

[0032] It could, for example, also be a tear-off sleeve which, due to predetermined breaking points in the material, can be divided longitudinally and can be torn open when the sleeve is pulled back - as is used, for example, in the implantation of a Pleurx catheter (subcutaneously tunneled thoracic drainage). Advantages

[0033] The modified breathing tube according to the invention enables, for the first time, endotracheal VAC therapy in a ventilated system such as the trachea. It is relatively simple and inexpensive to manufacture from readily available materials. The invention allows for tube changes after only three days and can be used as a single-use product.

[0034] The two cuffs and the sponge according to the invention make it possible to generate a negative pressure in the vacuum range, in which such a sponge can exert its healing effect.

[0035] For the first time, it is possible to utilize the advantages of the well-known VAC therapy even in ventilated systems, such as the trachea. Preferred embodiments

[0036] Preferably, the breathing tube (i.e., the tube that defines the main lumen) is made of a material selected from plastic (such as PVC (polyvinyl chloride), silicone, PUR (polyurethane)) or metal (such as silver). In particular, it can consist of at least 70% or even entirely of these materials.

[0037] In a preferred embodiment of the invention, the breathing tube also includes a vacuum tube for generating a negative pressure in the vacuum range (during use; it thus serves to aspirate air), wherein the diameters of the vacuum tube and the cuff tubes are each a maximum of 1 / 2 the diameter of the breathing tube; preferably even a maximum of 1 / 3 or a maximum of 1 / 4, or even a maximum of 1 / 5.

[0038] A preferred inner diameter for a vacuum hose is in the range of 0.1-0.2cm, and the outer diameter is in the range of 0.2-0.4cm.

[0039] In a further preferred embodiment of the invention: - When inflated, the cuffs can have a volume ranging from 2.4 to 12.1 cm³ 3 exhibit, and / or - the thickness of the cuff material is between 0.02 and 0.9 mm, and / or - the cuffs extend along the breathing tube for a length of 1 to 4 cm each.

[0040] The shorter the cuff, the more space is available for the sponge.

[0041] The volume of the cuffs is the volume of the cuff itself, excluding the volume of the endotracheal tube running through it. The volume is therefore calculated using the cylinder volume derived from the cuff's length and outer diameter, minus the volume of the endotracheal tube within that section.

[0042] An advantage of these cuff designs is that their dimensions and properties are particularly well-suited for use in tracheas. Individual versions of these three designs can be combined. According to the invention, a film is provided in the vacuum area that surrounds the sponge and thereby also encloses the breathing tube inside (so that only the two longitudinal ends protrude from the film).

[0043] Openings are created in the foil so that a negative pressure can be generated in the vacuum area (i.e., the injury area when used in the trachea).

[0044] The sponge may partially protrude through the opening(s) so that, when used, it can reach the inner wall of the trachea, where it is intended to cover the injury.

[0045] The film visibly seals the vacuum area (when used in the trachea, this is the space between the two cuffs, the inner wall of the trachea and the outer surface of the breathing tube in this length section separated by both cuffs).

[0046] The foil present in the invention ensures that the sponge does not come into contact with the entire circumference of the trachea, but rather that this negative pressure can only be built up in a single, defined area – because the foil allows the sponge to touch the trachea at the openings. The negative pressure can then only act on the inner wall of the trachea in this selected area.

[0047] According to the invention, this film completely encloses the sponge. Large-scale production of such a breathing tube is therefore easier. This embodiment according to the invention thus represents an advantageous design for delivery.

[0048] In a particularly preferred embodiment of this design (with a fully enclosing film), multiple (i.e., >10), preferably small (<1 mm), openings (i.e., perforations) are present in the film. In this case, these are symmetrically distributed over the film surface. According to the invention, there are >5 such openings.

[0049] The advantage of the variant with >10 openings, which are symmetrically distributed across the film, is that it allows for large-area suction of wound secretions without direct sponge contact.

[0050] In a particularly preferred variant of the vacuum tube design described above, the vacuum tube runs from outside the breathing tube into the sponge (at the level of the vacuum zone) below the first cuff and terminates there (inside the sponge or at least in the area between the sponge and the outer wall of the breathing tube), allowing air to be drawn from inside the sponge. The advantage of this variant is that the inner diameter of the breathing tube itself (i.e., the main lumen) is not reduced.

[0051] The existing film is pierced by the vacuum hose (from the outside).

[0052] In another, equally preferred variant of the above-described design with a vacuum tube, the vacuum tube runs from the upper end through the interior of the breathing tube (the so-called main lumen), and the breathing tube (i.e., the wall of the breathing tube itself) has a hole for the vacuum tube in the area of ​​the sponge (i.e., in the vacuum area of ​​the breathing tube), through which the vacuum tube runs (towards the outside, i.e., perpendicular or, better yet, at an angle to the longitudinal axis of the breathing tube) into the sponge and ends there, so that air can be drawn from the interior of the sponge.

[0053] The advantage of this design is that there is no separate protrusion on the outer surface of the breathing tube that would unnecessarily press on the trachea. However, this reduces the inner diameter (i.e., the main lumen), which can negatively affect the ventilation pressure.

[0054] In a preferred embodiment of the invention, the breathing tube is made of PVC (polyvinyl chloride) or silver, and / or the sponge is made of PVA (polyvinyl alcohol) or PUR (polyurethane), and / or (as a variant of one of the above versions with film) this film is made of a plastic selected from PP (polypropylene), PVC (polyvinyl chloride) and PTFE (polytetrafluoroethylene).

[0055] Preferably, the sponge in the invention is made of a hydrophobic material. In the case of polyvinyl alcohol, it is preferably hydrophobic, i.e., it has a degree of hydrolysis of >60%, preferably 70-99% or even >90%, and possibly >98%. In the case of polyurethane, it can be polyurethane containing silver.

[0056] The pore size of the sponge is preferably 0.4-2mm for polyurethane and preferably 0.4-4mm for polyvinyl alcohol.

[0057] The sponge preferably covers the entire area between the two cuffs (when viewed along the length of the breathing tube). In another preferred embodiment of the invention, the inner diameter of the breathing tube is 0.2–1.1 cm (preferably 0.6–1.1 cm, e.g., 0.8–1.1 cm for men, e.g., 0.7–0.9 cm for women). and / or the sponge has a thickness of 0.4-1.5cm when rolled out flat (but uncompressed) (preferably 0.5-1.2cm, or also 0.5-0.8cm).

[0058] The outer diameter is preferably 0.4-1.5cm (preferably 0.98-1.32cm).

[0059] The material of the breathing tube itself (i.e., the wall of the breathing tube) has, for example, a thickness of 0.04-0.2cm, or also 0.05-0.15cm.

[0060] In these dimensions, the breathing tube according to the invention is particularly suitable for tracheas. Its use with an insertion sleeve is also relatively simple, although compression is necessary and the insertion sleeve must not be too thick.

[0061] In another preferred embodiment of the invention, the distance between the two cuffs according to the invention, measured between the two adjacent outer surfaces of both cuffs, is 4-12 cm, preferably 6-10 cm, or even 8-10 cm. The two "adjacent outer surfaces" refer to those of the two cuffs that are also adjacent to the sponge and that run essentially perpendicular to the longitudinal axis of the breathing tube.

[0062] In another preferred embodiment of the invention, a flat end piece is provided at the upper end (of the breathing tube) above the first cuff, so that both cuffs are located on the same side of the flat end piece (the same side when viewed along the length of the main lumen of the breathing tube). The flat end piece can be a cannula shield, such as those known from prior art tracheostomy tubes.

[0063] In a preferred embodiment of the invention, the breathing tube according to the invention comprises: - a (second) cannula with a smaller outer diameter than the inner diameter of the breathing tube according to the invention (can also be referred to as the first tracheostomy cannula according to the invention), wherein the breathing tube has a hole for passing this cannula through, and - a third cuff as an inflatable balloon at a lower end of the cannula, with a third cuff tube, wherein the third cuff surrounds the cannula (also at a lower end) in a ring shape.

[0064] This version (as it is also in Fig. The design shown in Figure 3 is suitable for use in cases of tracheal injuries located very low down, near the bronchial branch. This is because, in such cases, there would be insufficient space within the trachea before the bronchial branch to place the second cuff below the injury. However, in this preferred design, it is possible to achieve a seal using the second and third cuffs within the respective main bronchi – below the injury.

[0065] The device is suitable for use in both non-tracheotomized and tracheotomized patients, but only when used with an endotracheal tube.

[0066] The size of the hole sensibly corresponds to the outer diameter of the (second) cannula, so that the best possible seal is achieved between the breathing tube and the cannula in the area of ​​the hole. The hole is to be understood as a "side branch," as known in vascular surgery. The breathing tube or "first tracheostomy tube" refers to the breathing tube according to the invention as such, i.e., reference numeral 1 in Fig. 1 or Fig. 3, corresponding to the main lumen).

[0067] The third cuff should ideally have the same preferred designs as the first and second cuffs. The (second) cannula should also have the same design as the breathing tube, except for the outer diameter.

[0068] The (second) cannula is particularly preferred if it tapers at its lower end and after the third cuff (and its outer diameter decreases by 0.2-1mm towards the end).

[0069] The wall (of the breathing tube) is particularly preferably curved inwards at this hole, so that nothing protrudes outwards from the breathing tube that could otherwise cause injury when inserted into a trachea.

[0070] Preferably the outer diameter of the (second) cannula is in the range of 0.35-0.65cm, or 0.45-0.65cm, or 5.5mm±10% or even only ±5%.

[0071] In the embodiment of the invention with a (second) cannula, it is also advantageous if the breathing tube and cannula have a hole in the side wall below the respective lower cuff, as shown in Fig. 3 can be seen in the lower left corner. This reduces the risk of the cannula becoming blocked. Fig. Figure 1 shows a preferred embodiment of the invention with foil (excerpt). Fig. Figure 2 shows a stylized (and excerpted) version of the invention according to the embodiment from Fig. 1. When used in the trachea, the tracheal wall is indicated by a dotted line. Cuff tubes or vacuum tubing are not shown. Fig. Figure 3 shows a second embodiment of the invention with a (second) cannula and a third cuff, which is suitable for injuries located near the branching of the trachea into the bronchi.

[0072] Unless otherwise specified, it is advisable to combine the different designs and variants.

[0073] The invention will now be explained in more detail with reference to several preferred embodiments. These embodiments are not intended to limit the invention. Examples of implementation Example 1:

[0074] Exemplary embodiment 1 is in Fig. Figure 1 shows a vacuum tube 5. This tube runs from the outside, below the first cuff 2a, into the sponge 3. A film 3b according to the invention seals the majority of the sponge from the breathing tube 1 (the main lumen, also referred to as the "first tracheostomy tube"). The breathing tube has an opening in the central area of ​​the vacuum chamber 6, through which the sponge can protrude slightly and be directed towards the wound during use.

[0075] Both cuffs 2a and 2b are each equipped with cuff tubes (4a and 4b) at the ends of which are control balloons. These balloons allow for inflation and monitoring of the tensioned state. A flat end piece (cannula shield) is attached to the upper end 20 of the breathing tube 1. Example 2:

[0076] A second embodiment is (in part) in Fig.Figure 3 shows that, in addition to the main lumen 1, there is a hole 9 through which a (second) cannula 8 can be inserted, at the outwardly projecting end of which (i.e., also at the level of the lower end 30 of the breathing tube 1) a third cuff 10 is provided. This cuff also surrounds the cannula 8 in a ring-like manner. Non-patented literature

[0077] Standard DIN EN ISO 5361 2023-08-00 “Anesthesia and ventilation equipment - Tracheal tubes and connectors” Reference sign 1 breathing tube 2a First Cuff 2b Second Cuff 3 sponges 3b slide (optional) 4a, 4b Two cuff hoses 5 vacuum hose 6 Vacuum area 7 Inner wall of the trachea 8 cannulas (with a smaller diameter than breathing tube 1) 9 holes (for inserting the cannula 8) 10 Third Cuff 20 Upper end of the breathing tube 30 Lower end of the breathing tube

Claims

[1] Modified breathing tube (1) for vacuum treatment of tracheal injuries of the windpipe, comprising: • a first cuff (2a) as an inflatable balloon at a first, upper end (20) of the breathing tube, with a first cuff tube (4a), • a second cuff (2b) as an inflatable balloon at a second, lower end (30) of the breathing tube, with a second cuff tube (4b), • a sponge (3) which is arranged between the two cuffs and surrounds the breathing tube, wherein both cuffs enclose the breathing tube in a ring shape, so that a vacuum area (6) extends between them in which a negative pressure can be created between the sponge and the tracheal wall, and wherein a film (3b) is provided in the vacuum region (6) which surrounds the sponge and thereby also encloses the breathing tube inside, wherein openings can be made through the film so that a negative pressure can be created in the vacuum region (6). wherein the foil (3b) completely encloses the sponge (3), and where >5 openings are present in the film (3b) and the openings are distributed symmetrically over the film surface. [2] Breathing tube according to claim 1, comprising a vacuum tube (5) for generating a negative pressure in the vacuum range, wherein the diameters of the vacuum tube and the cuff tubes (4a, 4b) are each a maximum of 1 / 2 the diameter of the breathing tube. [3] Breathing tube according to one of claims 1 or 2, wherein - the cuffs, when inflated, have a volume in the range of 2.4-12.1 cm³ 3 may exhibit, and / or - where the thickness of the material of the cuffs is between 0.02 and 0.9 mm, and / or - the cuffs extend along the breathing tube for a length of 1 to 4 cm. [4] A breathing tube according to one of claims 2 to 3, wherein the vacuum tube (5) extends from outside the breathing tube (1) into the sponge below the first cuff and terminates there, so that air can be drawn out of the interior of the sponge. [5] A breathing tube according to one of claims 2 to 3, wherein the vacuum tube (5) extends from the upper end (20) through the interior of the breathing tube (1) and the breathing tube has a hole for the vacuum tube in the area of ​​the sponge (3), through which the vacuum tube extends into the sponge and terminates there, so that air can be drawn from the interior of the sponge. [6] A breathing tube according to one of claims 1 or 4 to 5, wherein the tube is made of polyvinyl chloride, silicone, polyurethane or silver, and / or the film is made of plastic selected from PP, PVC, PTFE, and / or the sponge is made of PVA or PUR. [7] A breathing tube according to any one of claims 1 to 6, wherein the inner diameter is 0.2-1.1cm and the sponge has a thickness of 0.4-1.5cm when unrolled flat. [8] A breathing tube according to any one of claims 1 to 7, wherein the distance between the two cuffs, measured between the two adjacent outer surfaces of both cuffs, is 4-12cm. [9] A breathing tube according to any one of claims 1 to 8, comprising: - a cannula (8) with a smaller outer diameter than the inner diameter of the breathing tube (1), wherein the breathing tube (1) has a hole (9) for passing the cannula (8), and - a third cuff (10) as an inflatable balloon at a lower end of the cannula (8), with a third cuff tube, wherein the third cuff (10) surrounds the cannula (8) in a ring shape. [10] Set comprising a breathing tube according to one of claims 1 to 9 and an insertion sleeve with an inner diameter at least 0.2cm larger than the outer diameter of the breathing tube (1), so that it can be slipped over the breathing tube (1) and thus inserted into the trachea.

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