Ear catheter for administering medication

Abstract

The present invention relates to an ear catheter for insertion into the middle ear region through an incision in the tympanic membrane, comprising a catheter tube (2) having a distal end (d) and a proximal end (p), the catheter tube (2) comprising at least three lumens: a first lumen in the form of a dosing lumen (3), a second lumen in the form of an extension lumen (4), and a third lumen in the form of a pressure release lumen (5), the ear catheter (1) further comprising a first distal sealing element (6) and a second sealing element (7) arranged proximal to the first sealing element (6), the sealing elements (6, 7) forming a dosing region in the distal region of the catheter tube (2), at least the first sealing element (6) being in the form of an inflatable balloon connected in a fluid-permeable manner to the extension lumen (4). The ear catheter according to the present invention allows for the effective treatment of middle ear diseases.

Description

[Technical Field]

[0001] The present invention relates to an ear catheter for administering medication to the Eustachian tube, the ear catheter being capable of being placed in the middle ear region, particularly through an access point in the tympanic membrane. [Background technology]

[0002] Numerous diseases of the middle and inner ear are known that require local treatment. When local treatment is required, it can be performed either through the eardrum or through the Eustachian tube. Treatment of the inner ear can also be performed through the middle ear region. For treatment, an ear catheter inserted through the nose is often used to introduce medication. However, administration of medication, especially in liquid form, to the Eustachian tube or middle ear is often not sustained, as the medication usually flows into the nasopharynx immediately after administration.

[0003] Treatment of various infections and inflammations, such as hearing loss or Meniere's disease, requires long-term administration of medications into the Eustachian tube or middle ear, which can sometimes last for days or weeks. Typically, in these cases, new medications, such as corticosteroids, are introduced at regular intervals. This treatment is time-consuming and requires regular and sustained medical supervision and care.

[0004] For this reason, it would be desirable to have an ear catheter that can be used to administer medication to the middle ear and remain there for an extended period of time.

[0005] Patent Document 1 describes an ear catheter that can be inserted into the Eustachian tube via the nasopharynx and includes an expandable balloon for sealing off the nasopharynx. An infusion channel extends through the balloon, and at the distal end of the balloon, a drug can be administered into the Eustachian tube, preventing the drug from flowing back through the balloon and into the nasopharynx.

[0006] The administration of drugs using known ear catheters is carried out non-invasively via the nasopharynx and the Eustachian tube.

[0007] However, placing an ear catheter through a patient's nose is not always easy, and in some cases, it is impossible. Furthermore, placement requires some training. When the catheter is constructed of a very flexible material, additional insertion aids must often be used to place the catheter. This results in the use of additional material and additional cost.

[0008] Therefore, there are situations in which administering medication to the middle ear region is advantageously performed invasively through the tympanic membrane rather than through the nasopharynx. Transtympanic membrane interventions, in which a small incision or puncture is made in the tympanic membrane, have been used for a long time and, based on experience, have been successfully performed without complications. They are used, for example, to drain fluid accumulations from the tympanic cavity. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] German Patent Application Publication No. 102018102937 Summary of the Invention [Problem to be solved by the invention]

[0010] Therefore, one of the problems solved by the present invention is to provide an ear catheter that has drug administration options and is suitable for invasive application via the tympanic membrane.

[0011] Another problem solved by the present invention is to provide an ear catheter that has drug administration options and can be used without additional insertion aids.

[0012] In particular, one of the problems solved by the present invention is to provide an ear catheter that has drug delivery options and includes a device that can retain the delivered drug at the delivery site for an extended period of time. [Means for solving the problem]

[0013] This problem is solved by the present invention with the features of claims 1, 7 and 9. Advantageous configurations are set out in the dependent claims. It should be noted that the features individually defined in the claims can be combined with one another in any technically feasible manner and thus represent further configurations of the invention.

[0014] The ear catheter according to the invention comprises a catheter tube having a distal end and a proximal end, and in a first embodiment, the catheter tube comprises at least three lumens: a first lumen in the form of a dosing lumen, a second lumen in the form of an extension lumen, and a third lumen in the form of a pressure relief lumen. In a second embodiment, the ear catheter comprises only two lumens: a first lumen in the form of a dosing lumen and a second lumen in the form of an extension lumen. In a third embodiment, the ear catheter comprises only the first lumen in the form of a dosing lumen.

[0015] In the context of the present invention, "distal" refers to the portion of the device that points along the ear catheter away from the user, and "proximal" refers to the portion of the device that points along the ear catheter towards the user. Further details regarding positional relationships can be seen in the drawings.

[0016] In a first embodiment, the catheter tube of the ear catheter preferably comprises at least three lumens: a first lumen in the form of an administration lumen, a second lumen in the form of an extension lumen, and a third lumen in the form of a pressure relief lumen.

[0017] The administration lumen extends through the catheter tube from the proximal end to the administration region and opens to the exterior at the administration region through an opening, i.e., the administration opening, for administering a drug through the opening at the administration region.

[0018] The dosing region is located at the distal region or end of the catheter tube.

[0019] The administration lumen may optionally be provided with a closure device, e.g. a one-way valve, preferably in the form of a duckbill valve, which prevents the administered active ingredient from escaping proximally through the administration lumen. A corresponding valve is preferably provided at the proximal end of the administration lumen, in any case proximal to the administration orifice.

[0020] Alternatively, if designed as a balloon, it is also possible to seal the administration lumen, which may consist of a soft plastic tube, by means of a second sealing element, thus closing off the administration lumen.

[0021] Typically, for the introduction of a liquid active substance, the proximal end of the administration lumen is preferably equipped with a conventional connection, in particular a Luer lock, to which, for example, a syringe for introducing an active substance solution can be connected.

[0022] In a first variant of the ear catheter, the administration area is delimited distally by a first sealing element and proximal to the first sealing element by a second sealing element.

[0023] The first sealing element is used to seal the middle ear region from the nasopharynx, preventing the drug administered to the middle ear region from flowing into the nasopharynx and remaining at the site of action. The first sealing element is preferably provided in the form of a balloon, and only minimal overpressure is applied to the balloon to close the Eustachian tube. Therefore, this first sealing element is deployed or expanded after the catheter is placed through the tympanic membrane.

[0024] The second sealing element is used to seal the middle ear region from the outer ear, preventing, to the greatest extent possible, leakage of the administered medication through the incision in the tympanic membrane. The second sealing element can also be provided as an expandable balloon, but can also be provided as a separate seal, for example in the form of a sealing ring or other sleeve-like device, which is preferably made of silicone or other flexible sealing material and is preferably movable along the catheter tube.

[0025] Preferably, the second sealing element is provided for sealing the tympanic membrane on the outside of the tympanic membrane. In an alternative embodiment, the second sealing element may be provided in the form of a balloon, in this embodiment for sealing the tympanic membrane on the inside as well.

[0026] If the second sealing element is also provided in the form of an expandable balloon, this second sealing element may also be connected to the expansion lumen in a fluid-permeable manner, which is advantageous since the first and second sealing elements are expandable simultaneously by the expansion lumen, which simplifies handling.

[0027] In an alternative embodiment comprising two expandable balloons as the first and second sealing elements, the catheter tube can include two expansion lumens, with the first expansion lumen connected to the first sealing element and the second expansion lumen connected to the second sealing element.

[0028] The expansion lumen extends through the catheter tube from the proximal end to the first sealing element and is fluidly connected to the first sealing element and optionally the second sealing element, and is provided for expanding and contracting the first sealing element and optionally the second sealing element.

[0029] At the proximal end of the catheter tube, the entrance to the extension lumen and the entrance to the delivery lumen may be of different shapes to prevent confusion during use.

[0030] The pressure relief lumen extends through the catheter tube from the proximal end to the administration region and opens to the outside at the administration region, for relieving pressure in the administration region or the middle ear.

[0031] To minimize leakage of the administered active substance through the pressure release lumen to the outside of the administration area, the pressure release lumen preferably includes a valve or valve-like device, which allows pressure release and prevents indiscriminate leakage of the active substance. This means that, in particular, when no overpressure is formed, the active substance will minimize leakage through the pressure release lumen. Therefore, the corresponding valve can be designed to simply cover the outlet opening in the pressure release lumen without requiring a large pressure on the opening.

[0032] The region of the catheter between the first and second sealing elements is referred to as the administration region. The administration region therefore includes the region of the catheter where the drug is applied to the middle ear region and can act on the inner or middle ear region. The administration region is therefore intended to include at least the region to be treated, and preferably corresponds as accurately as possible to this region.

[0033] When the first sealing element reaches the location within the ear, ie the portion of the middle ear that is to be closed, for example the Eustachian canal, liquid is applied to the balloon of the sealing element, which is expanded in a known manner.

[0034] To inflate the balloon, preferably saline solution acts as the liquid. To introduce the liquid, the proximal end of the inflation lumen is provided with a conventional connection, in particular a Luer lock, to which a syringe for saline solution can be connected. The catheter tube is designed with a corresponding valve, for example a one-way valve, so that the balloon maintains pressure.

[0035] When two inflation lumens are provided, the proximal connections of both inflation lumens are provided with conventional connections, in particular Luer locks, to which a syringe for introducing a liquid can be connected. The inflation lumens are designed with corresponding valves, for example one-way valves, preferably duckbill valves, so that the balloons maintain their respective pressures.

[0036] In this case, it is advantageous to design the balloon as a low-pressure cuff and provide a pressure limiting device in the inflation lumen to limit the pressure to a low level as a safety measure. Preferably, the valve is an umbrella valve. Standard materials can be used for the balloon and catheter. These include medically approved plastic materials such as PVC, polyamide, polyethylene, and polypropylene. The material must be sufficiently elastic to allow insertion into the Eustachian canal.

[0037] According to a second embodiment, an ear catheter is considered, comprising a tube in the form of a catheter tube having a distal end and a proximal end, comprising a first lumen in the form of an administration lumen and a second lumen in the form of an extension lumen.

[0038] This embodiment substantially corresponds to the first variant, but the pressure relief lumen is omitted, since in this variant a second, more proximally located sealing element is provided and any overpressure that may build up in the middle ear can be reduced by the incision made in the tympanic membrane.

[0039] Therefore, all statements and explanations regarding the first embodiment also apply to this second embodiment, particularly as they relate to the administration lumen, the extension lumen, and the first or distal sealing element.

[0040] According to a third embodiment, a variant of the ear catheter is considered, which comprises a tube in the form of a catheter tube having a distal end and a proximal end, a first lumen in the form of an administration lumen and an additional administration device.

[0041] In this variation, the administration lumen is not primarily for direct administration of a drug, but for accommodating and positioning an administration device. The administration lumen extends through the catheter tube from the proximal end to the administration area and opens to the outside through an opening. The opening of the administration lumen is preferably at the distal end of the administration lumen, or the open distal end of the administration lumen forms this opening. Thus, an administration device can be advanced through the administration lumen and through the distal opening of the administration lumen to an administration site, for example, in the middle ear.

[0042] In this third embodiment, even if the administration lumen is not primarily provided for directly administering a drug and preferably does not have a corresponding closure, the administration lumen may optionally still be suitable for administering a drug, for example, to introduce more drug into the administration element, as will be further described below.

[0043] The administration device can be designed differently but typically comprises a tubular or wire-like introducer element, for example in the form of an introducer wire or guide wire, and an administration element provided distal to the introducer element.

[0044] The administration element can also be fixed to the introduction element via a connecting element, which may be part of the introduction element. Alternative embodiments are envisaged in which the administration element is itself part of the introduction element or is fixed to the introduction element directly, i.e. without special connecting elements, for example by gluing, welding or other known connection techniques.

[0045] The introducing element can be made of any material that must be sufficiently rigid to allow the advancement of the administration device within the administration lumen. Suitable materials are known to those skilled in the medical technology field.

[0046] The distal end of the administration, introduction, or connection element should be designed to be atraumatic to prevent damage to the sensitive middle ear region when it is placed. The distal end of the ear catheter itself should also be atraumatic to prevent damage during placement of the ear catheter.

[0047] The administration element is the actual carrier of the administered drug and serves to administer and place the drug in the middle ear region. The administration element is therefore suitable for containing and then administering the administered drug.

[0048] Possible configurations and materials for the administration element may include woven or nonwoven fleece materials, structures made of shape memory materials, or polymers such as wire mesh or coils, as well as combinations of the above configurations and materials. Thus, the administration element is any structure suitable for containing and then presenting for administration of a drug to the middle ear for at least a predetermined period of time.

[0049] The structure according to the invention made from a shape memory material or polymer may be, for example, a wire, strand, thread mesh or spiral suitable for containing a substantially liquid or pasty drug. It is also conceivable to directly coat the corresponding mesh or spiral with a drug or a drug-carrying coating, for example in the form of a specific drug-carrying or drug-embedded coating.

[0050] Further suitable combinations for such administration elements are, for example, textile coatings or fleeces or wires, meshes or spirals with sponge-like or porous plastic materials.

[0051] Woven fabrics or fleece or spongy or porous plastic materials that may additionally be arranged in a kind of cage are also considered as administration elements, this cage being made, for example, from a shape memory material or a material with shape memory properties.

[0052] Drug-coated balloons or drug delivery balloon reservoirs are possible delivery elements.

[0053] Depending on the type of administration element, the administration lumen can also be used to introduce new drugs into the administration element, which is useful in this type of administration element that can accommodate new drugs in the manner of a reservoir, for example administration elements with sponge-like properties, balloons or meshes.

[0054] In an alternative variant of this third embodiment, a first sealing element can be provided at the distal end of the ear catheter, according to this embodiment the first sealing element is preferably formed by one or more fins, which are preferably arranged annularly at the distal end of the administration element and are designed to be flexible so as to be able to seal the administration area from the oropharyngeal cavity in a fluid-tight manner.

[0055] Such a fin-like sealing element can assume a compressed state within the administration lumen and, when released, can assume an expanded state around the middle ear, which has a larger diameter than in the compressed state.

[0056] Such a configuration of the distal sealing element with a fin structure can lead to complications when removing the ear catheter through the tympanic membrane, especially since the distal sealing element, which is provided in the form of a fin, cannot easily return from the expanded state to the compressed state and therefore cannot be pulled back into the administration lumen.

[0057] Thus, particularly in embodiments having a fin-shaped distal sealing element, a preferably thread-like or wire-shaped retrieval element may optionally be provided at the distal end of the ear catheter, whereby the ear catheter can alternatively be removed via the oropharyngeal cavity.

[0058] The balloons and catheters of all embodiments can be made of standard materials known in the medical art for catheter or balloon catheter technology, especially medically approved plastic materials such as PVC, polyamide, polyethylene, polypropylene, etc. The material must be sufficiently elastic to allow insertion through the tympanic membrane into the middle ear.

[0059] The ear catheter according to the present invention is particularly suitable for the insertion of antibiotic solutions through the eardrum into the middle ear region, which is useful for chronic bacterial infections. Standard treatment for hearing loss, which is performed with corticosteroids, can also be usefully administered via such an ear catheter.

[0060] In all its variants and embodiments, by providing a continuous supply of active substance, the ear catheter according to the invention allows for a much more intensive and shorter treatment, both in single treatments and in patients in whom access via the oropharyngeal cavity is not possible and instead must be via the tympanic membrane, thus shortening the treatment time even for these patients, potentially to a few days.

[0061] Additionally, anti-inflammatory medications can be inserted through the ear catheter.

[0062] After treatment, the ear catheter can be removed from the ear again, after which the pressure is released and the balloon is deflated, if necessary.

[0063] Auricular catheters also allow for the treatment of diseases of the inner ear, as drugs can generally pass through the membrane of the round window into the inner ear, a process of diffusion.

[0064] The present invention also relates to a method for administering a drug to the middle ear through the tympanic membrane using an ear catheter according to the present invention, the method comprising the steps of: (A) Making an incision in the eardrum; (B) inserting an ear catheter according to the present invention through the incision in the tympanic membrane; (C) placing an ear catheter into the middle ear; (D) optionally expanding the first sealing element and / or the second sealing element; and (E) optionally administering a drug or inserting an administration device through the administration lumen; and (F) optionally administering further medication through the administration lumen; (G) optionally, shrinking the first sealing element and / or the second sealing element; and (H) optionally, performing an additional pressure release; and (I) Removal of ear catheter.

[0065] The present invention and the technical field will be explained in more detail below with reference to the drawings. It should be noted that the drawings show particularly preferred variants of the present invention. However, the present invention is not limited to the variants shown. Insofar as technically possible, the present invention includes any combination of the technical features particularly recited in the claims or described in the specification as being relevant to the present invention. [Brief explanation of the drawings]

[0066] [Figure 1] FIG. 1 illustrates an access point through an incision in the tympanic membrane for an ear catheter according to the present invention. [Figure 2] 1 shows a first embodiment of an ear catheter according to the invention; [Figure 3] 1 shows a first embodiment of an ear catheter according to the invention with an alternative selection of second sealing elements; [Figure 4] FIG. 2 shows a second embodiment of an ear catheter according to the invention having only a single first sealing element. [Figure 5] FIG. 3 shows a third embodiment of an ear catheter according to the invention without a sealing element but with a dosing element. [Figure 6] 3 shows a variant of the third embodiment of the ear catheter according to the invention with a first sealing element; DETAILED DESCRIPTION OF THE INVENTION

[0067] FIG. 1 shows a schematic representation of a human ear with a tympanic membrane T and the site of an incision E for introducing an ear catheter according to the invention.

[0068] 2 shows a first embodiment of an ear catheter 1 according to the invention, comprising a catheter tube 2 having an administration lumen 3, an extension lumen 4, and a pressure release lumen 5. The catheter tube 2 has an atraumatically formed tip 8 at its distal end to prevent damage to the sensitive middle ear during placement of the ear catheter 1. A first sealing element 6 in the form of an expandable balloon is provided at the distal end of the catheter tube 2, and is fluid-permeable connected to the extension lumen 4. A second sealing element 7 in the form of an expandable balloon, also fluid-permeable connected to the extension lumen 4, is provided more proximally and positioned outside the middle ear in the ear canal. In an alternative embodiment, separate extension lumens 4 may be provided for each of the sealing elements 6, 7.

[0069] The first and second sealing elements 6, 7 form a dosing area AB into which an active substance can be administered via the dosing lumen 3 through the opening 3a of the dosing lumen 3. The overpressure created by administering the active substance in the dosing area AB is equalized by the opening 5a of the pressure release lumen 5. To prevent the active substance from leaking out through the dosing lumen 3 or the pressure release lumen 5, these lumens can be equipped with corresponding valves.

[0070] 3 shows a second embodiment of an ear catheter 1 according to the invention, comprising a catheter tube 2 having an administration lumen 3, an inflation lumen 4 and a pressure release lumen 5. The catheter tube 2 is provided with an atraumatically formed tip 8 at its distal end to prevent damage to the sensitive middle ear when placing the ear catheter 1. A first sealing element 6 in the form of an expandable balloon is provided at the distal end of the catheter tube 2, which is connected in a fluid-permeable manner to the inflation lumen 4.

[0071] A second sealing element 7 in the form of a closure annularly arranged around the catheter tube 2 is positioned more proximally and outside the middle ear in the ear canal. This second sealing element 7 is preferably made of silicone or another sealing and flexible material. The diameter of this second sealing element 7 is selected to provide at least one form fit between the second sealing element 7 and the ear canal. In this embodiment, this second sealing element 7 may comprise multiple annular or disk-shaped elements in series, as shown.

[0072] In this embodiment too, the first and second sealing elements 6, 7 form a dosing area AB into which an active substance can be administered via the dosing lumen 3 through the opening 3a of the dosing lumen 3. The overpressure created by administering the active substance in the dosing area AB is equalized by the opening 5a of the pressure release lumen 5. To prevent the active substance from leaking out through the dosing lumen 3 or the pressure release lumen 5, these lumens can be equipped with corresponding valves.

[0073] 4 shows a third embodiment of an ear catheter 1 according to the invention, comprising a catheter tube 2 having an administration lumen 3 and an extension lumen 4. The catheter tube 2 is provided with an atraumatically formed tip 8 at its distal end to prevent damage to the sensitive middle ear when placing the ear catheter 1. A first sealing element 6 in the form of an expandable balloon is provided at the distal end of the catheter tube 2, which is connected in a fluid-permeable manner to the extension lumen 4. This embodiment does not comprise a second sealing element further proximally.

[0074] In this embodiment, the dosing area AB is formed by the first sealing element 6 and the tympanic membrane, and the second sealing element is omitted. The most precise possible shape fit between the catheter tube 2 and the tympanic incision prevents excessive amounts of medication from leaking through the tympanic membrane. An active substance can be administered to the dosing area AB via the dosing lumen 3 through the opening 3a of the dosing lumen 3. Overpressure resulting from the administration of the active substance in the dosing area AB can escape through the incision in the tympanic membrane. Therefore, in this case, the pressure relief lumen can be omitted, and the corresponding lumen 5.1 can optionally be used as a guidewire lumen. To prevent the active substance from leaking through the dosing lumen 3, the dosing lumen 3 may be provided with a corresponding one-way valve, preferably located proximally.

[0075] 5 shows another embodiment of an ear catheter 1 according to the invention, comprising a catheter tube 2 with a dosing lumen 3. This embodiment does not include a sealing element, since the drug is administered by means of a dosing element 10, which is suitable for long-term retention and administration to the middle ear. The dosing element 10 is provided at the distal end of the introducing element 9, allowing it to be advanced through the dosing lumen 3 to the dosing area AB. As shown in this case, the dosing element 10 can be connected to the introducing element 9 via a connecting element 11. In this case, the connecting element 11 is provided in the form of a nitinol basket, which surrounds the dosing element 10 and thus assumes a collapsed state inside the dosing lumen 3 and a reversibly expanded state outside the dosing lumen 3.

[0076] In the illustrated embodiment, the administration element 10 is provided in the form of a sponge-like element suitable for containing a drug, which can optionally be introduced into the administration element 10 via the administration lumen 3 after placement of the administration element 10. This can be useful, as the administration element 10 also assumes a compressed state inside the administration lumen 3 and can therefore optionally absorb only a small amount of drug compared to its expanded state outside the administration lumen 3.

[0077] In this embodiment, the dosing range AB corresponds substantially to the length of the dosing element 10 that administers the drug to the middle ear.

[0078] 6 shows another embodiment of an ear catheter 1 according to the invention, comprising a catheter tube 2 with a dosing lumen 3. This embodiment comprises a distal sealing element 6' formed by one or more fins, preferably annular and arranged at the distal end of the dosing element 10, and designed to be flexible so as to be able to seal the dosing area AB from the oropharyngeal cavity in a fluid-tight manner.

[0079] The administration element 10 is provided at the distal end of the introduction element 9, allowing the administration element 10 to be advanced through the administration lumen 3 to the administration area AB. As shown in this case, the administration element 10 can be directly connected to the introduction element 9, for example by adhesive or other techniques.

[0080] In the illustrated embodiment, the administration element 10 is provided in the form of a sponge-like element suitable for containing a drug, which can optionally be introduced into the administration element 10 via the administration lumen 3 after placement of the administration element 10. This can be useful, as the administration element 10 also assumes a compressed state inside the administration lumen 3 and can therefore optionally absorb only a small amount of drug compared to its expanded state outside the administration lumen 3.

[0081] In this embodiment, the dosing area AB corresponds substantially to the length of the dosing element 10 that administers the drug to the middle ear.

[0082] In this embodiment, since the distal sealing element 6' is formed by one or more fins, it may be useful to remove the ear catheter 1 through the nasopharynx rather than through an incision in the tympanic membrane. For this purpose, the distal end of the catheter 1 is provided with a retrieval element 12, for example in the form of a floss, by means of which the catheter 1 can be grasped and removed through the oral and nasal cavities.

[0083] Optionally, it is also useful to place this embodiment through the oropharyngeal cavity and guide the catheter tube 2 with the administration lumen 3 through the tympanic membrane to administer the new medication. [Explanation of symbols]

[0084] 1 ear catheter 2 catheter tubes 3. Dosing lumen (3a. Opening of the dosing lumen, dosing opening) 4 Extended Lumens 5 Pressure relief lumen (5a Pressure relief lumen opening) 6 First sealing element 7 Second sealing element 8 Atraumatic tip 9. Introduction Elements 10 Administration Elements 11 Connected Elements 12 Recovery Elements AB Administration area p proximal d. distal

Claims

1. An ear catheter for insertion into the middle ear region through an incision in the tympanic membrane, comprising a catheter tube (2) having a distal end (d) and a proximal end (p); The catheter tube (2) comprises at least three lumens: a first lumen in the form of an administration lumen (3), a second lumen in the form of an expansion lumen (4), and a third lumen in the form of a pressure relief lumen (5); The ear catheter (1) further comprises a first distal sealing element (6) and a second sealing element (7) disposed proximally of the first sealing element (6), the sealing elements (6, 7) form a dosing area in the distal region of the catheter tube (2), and at least the first sealing element (6) is provided in the form of an expandable balloon connected to the inflation lumen (4) in a fluid-permeable manner; Ear catheter.

2. 2. An ear catheter according to claim 1, characterized in that the second sealing element (7) is provided in the form of an expandable balloon.

3. 3. An ear catheter according to claim 1 or 2, characterized in that the second sealing element (7) is connected to the expansion lumen (4) in a fluid-permeable manner.

4. 3. An ear catheter according to claim 1 or 2, characterized in that the catheter tube comprises a second extension lumen, and the second sealing element (7) is connected to the second extension lumen in a fluid-permeable manner.

5. 2. An ear catheter according to claim 1, characterized in that the second sealing element (7) is provided in the form of a sealing ring around the catheter tube.

6. 6. An ear catheter according to claim 5, characterized in that the second sealing element (7) is movably mounted along at least a portion of the catheter tube (2).

7. An ear catheter for insertion into the middle ear region through an incision in the tympanic membrane, comprising a catheter tube (2) having a distal end (d) and a proximal end (p); said catheter tube (2) comprising only two lumens, namely a first lumen in the form of an administration lumen (3) and a second lumen in the form of an extension lumen (4); The ear catheter (1) further comprises only a first distal sealing element (6), which is connected to the extension lumen (4) in a fluid-permeable manner. provided in the form of an expandable balloon, Ear catheter.

8. An ear catheter according to any one of claims 1 to 7, characterized in that the catheter tube (2) is provided with an atraumatically formed tip (8) at its distal end.

9. 1. An ear catheter for insertion through the tympanic membrane into the middle ear region, comprising: a catheter tube (2) having a distal end and a proximal end, and an administration device comprising an introduction element (9) and an administration element (10) provided distal to the introduction element (9); the catheter tube (2) comprises a lumen extending from the proximal end to the distal end in the form of an administration lumen (3); The administration lumen (3) is provided for inserting the administration device from the proximal end of the catheter tube (2) through the administration lumen (3) to the distal end of the catheter tube (2). Ear catheter.

10. 10. The ear catheter according to claim 9, wherein the administration element (10) is suitable for applying and precisely positioning a drug in the middle ear region and comprises a woven or nonwoven fleece material, a structure made of a shape memory material or a polymer such as a wire mesh or a coil, as well as combinations of the above configurations and materials.

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