Ear catheter for applying medication

Abstract

The invention relates to an ear catheter for introducing into the middle ear through a cut in the ear drum, comprising a catheter tube (2) with a distal (d) and a proximal (p) end, wherein the catheter tube (2) comprises at least three lumen, namely a first lumen as an application lumen (3), a second lumen as an inflation lumen (4), and a third lumen as a pressure-relieving lumen (5), and the ear catheter (1) additionally has a first distal seal element (6) and a second seal element (7) placed proximally to the first seal element (6). The seal elements (6, 7) form an application region in the distal region of the catheter tube (2), and at least the first seal element (6) is provided as an inflatable balloon which is connected to the inflation lumen (4) in a fluid-permeable manner. The ear catheter according to the invention allows an effective treatment of diseases of the middle ear.

Description

[0001] Ear catheter for administering medication

[0002] The invention relates to an ear catheter for administering medication into the Eustachian tube, wherein the ear catheter can be placed in the middle ear region, in particular through an access in the eardrum.

[0003] Numerous diseases of the middle and inner ear are known to require topical treatment. If topical treatment is necessary, it can be administered either through the eardrum or the Eustachian tube. Treatment of the inner ear can also be performed via the middle ear region. An ear catheter inserted through the nose is often used for treatment, also for administering medication. However, administering medication into the Eustachian tube or middle ear, especially in liquid form, is often not sustainable, as the medication typically drains into the nasopharynx shortly after application.

[0004] The treatment of a number of infections and inflammations, such as sudden hearing loss or Meniere's disease, requires the long-term administration of medication into the Eustachian tube or middle ear, which can sometimes last for days or a few weeks. Typically, in these cases, a new medication, such as a corticosteroid, is administered at regular intervals. This treatment is time-consuming and requires regular and ongoing medical monitoring and care. For this reason, it would be desirable to have an ear catheter with which a medication can be administered into the middle ear and stored there for an extended period.

[0005] DE 10 2018 102 937 A1 describes an ear catheter that can be inserted into the Eustachian tube via the nasopharynx and includes an expandable balloon to seal it off. An injection channel is routed through the balloon, allowing a medication to be administered distally to the Eustachian tube. The balloon prevents the medication from flowing back into the nasopharynx.

[0006] The medication is administered non-invasively using the well-known ear catheter via the nasopharynx and the auditory tube (the Eustachian tube).

[0007] However, placing an ear catheter through a patient's nose is not always easy and may not be possible. It also requires some practice. If the catheter is made of a very flexible material, an additional introducer is often required to place the catheter. This requires additional material and additional costs.

[0008] There are therefore situations in which medication can be administered invasively through the eardrum rather than through the nasopharynx. Procedures through the eardrum, which involve a small incision in the eardrum—a paracentesis—have been performed for some time and, in our experience, heal without complications. They are used, for example, to drain fluid accumulation from the tympanic cavity.

[0009] It is therefore an object of the invention to provide an ear catheter with the ability to deliver medication, which is suitable for invasive use through the eardrum. Furthermore, it is an object of the invention to provide an ear catheter with the ability to deliver medication, which can also be used without additional insertion aids.

[0010] Last but not least, it is an object of the invention to provide an ear catheter with the possibility of drug delivery, which comprises a device that can keep the delivered drug at the application site for a longer period of time.

[0011] This object is achieved by an invention having the features of claims 1, 7, and 9. Advantageous embodiments are the subject of the dependent claims. It should be noted that the features listed individually in the claims can also be combined with one another in any desired and technologically expedient manner, thus revealing further embodiments of the invention.

[0012] An ear catheter according to the invention comprises a catheter tube with a distal and a proximal end. In a first embodiment, the catheter tube comprises at least three lumens, namely a first lumen as an application lumen, a second lumen as an inflation lumen, and a third lumen as a pressure relief lumen. In a second embodiment, the ear catheter comprises only two lumens, namely a first lumen as an application lumen and a second lumen as an inflation lumen. In a third embodiment, the ear catheter comprises only a first lumen as an application lumen.

[0013] In the context of the present invention, "distal" refers to the part of the device along the ear catheter facing away from the user, while "proximal" refers to the part along the ear catheter facing toward the user. Further details regarding the positional relationships can be found in the figures.

[0014] In the first embodiment, the catheter tube of the ear catheter preferably comprises at least three lumens, namely a first lumen as an application lumen, a second lumen as an inflation lumen and a third lumen as a pressure relief lumen.

[0015] The application lumen runs through the catheter tube from the proximal end to the application area and opens outward through an opening, the application port, in the application area. The application lumen is designed for administering medication through the opening into the application area.

[0016] The application area is provided in the distal area or at the distal end of the catheter tube.

[0017] The application lumen can optionally include a closure, for example a one-way valve, preferably in the form of a duckbill valve, which prevents the applied active ingredient from flowing proximally through the application lumen. The corresponding valve is preferably provided at the proximal end of the application lumen; in any case, it should be provided proximal to the application opening.

[0018] Alternatively, it is also possible to squeeze the application lumen, which may consist of a soft plastic tube, with the help of the second sealing element, provided that this is designed as a balloon, and thus bring about a closure of the application lumen.

[0019] For the introduction of a generally liquid active substance, the proximal end of the application lumen is preferably provided with a conventional connection, in particular a Luer lock, to which, for example, a syringe for the introduction of the active substance solution can be coupled.

[0020] In the first variant of the ear catheter, the application area is defined distally by a first sealing element and proximal to the first sealing element by a second sealing element. The first sealing element serves to seal the middle ear region from the nasopharynx, preventing medications administered into the middle ear region from flowing there but remaining at the site of application. The first sealing element is preferably designed as a balloon, with the balloon being subjected to only minimal overpressure for sealing, thus closing the Eustachian tube. Accordingly, this first sealing element is only deployed or inflated after the catheter has been placed through the eardrum.

[0021] The second sealing element serves to seal the middle ear region from the outer ear, preventing any administered medication from escaping through the incision in the eardrum. The second sealing element can also be provided as an inflatable balloon, but it can also be provided as another seal, for example, in the form of a sealing ring or other cuff-like device, preferably made of silicone or another flexible, sealing material and preferably movable, i.e., displaceable, along the catheter tube.

[0022] Preferably, the second sealing element for sealing the eardrum is provided on the outside of the eardrum. In an alternative embodiment, the second sealing element in the balloon embodiment can also be provided on the inside of the eardrum for sealing the eardrum.

[0023] If the second sealing element is also provided as an inflatable balloon, this second sealing element can also be connected to the inflation lumen in a fluid-permeable manner. This is advantageous because the first and second sealing elements can be inflated simultaneously through an inflation lumen, simplifying handling.

[0024] In the alternative embodiment with two inflatable balloons as the first and second sealing elements, the catheter tube can comprise two inflation lumens, wherein the first inflation lumen is connected to the first sealing element and the second inflation lumen is connected to the second sealing element. The inflation lumen runs through the catheter tube from the proximal end to the first sealing element and is fluidly connected to the first and, optionally, the second sealing element. The inflation lumen is provided for inflating or deflating the first and, optionally, the second sealing element.

[0025] At the proximal end of the catheter tube, the inlet of the inflation lumen(s) and the application lumen may be shaped differently to avoid confusion during operation.

[0026] The pressure relief lumen runs through the catheter tube from the proximal end to the application site and opens outward at the application site. It is intended to relieve pressure in the application site, i.e., the middle ear.

[0027] To ensure that as little as possible of the applied active ingredient can escape from the application area through the pressure relief lumen, the pressure relief lumen preferably comprises a valve or a valve-like device that, on the one hand, enables pressure relief and, on the other hand, prevents the drug from accidentally escaping. This specifically means that, if possible, no active ingredient should escape through the pressure relief lumen unless overpressure has built up. A corresponding valve can be designed such that it merely covers the outlet opening of the pressure relief lumen, but without requiring any significant overpressure to open.

[0028] The area of ​​the catheter between the first and second sealing elements is referred to as the application area. The application area thus encompasses the area of ​​the catheter where the medication is administered into the middle ear region and can interact with the inner or middle ear region. Accordingly, the application area should at least encompass the area to be treated, and preferably, it should correspond to it as closely as possible. As soon as the first sealing element has reached the application site within the ear, i.e., the part of the middle ear to be sealed, for example, the Eustachian tube, the balloon of the sealing element is filled with a fluid in a known manner and expanded.

[0029] The fluid used to expand the balloon is preferably a physiological saline solution. To introduce the fluid, the proximal end of the inflation lumen is equipped with a conventional connector, particularly a Luer lock, to which a syringe for the saline solution can be connected. The catheter tube is equipped with a corresponding valve, for example, a one-way valve, to ensure the balloon maintains pressure.

[0030] If two inflation lumens are provided, the proximal connections of both inflation lumens are equipped with a conventional connector, particularly a Luer lock, to which a syringe can be connected for fluid injection. The inflation lumens are equipped with appropriate valves, such as one-way valves and preferably duckbill valves, to ensure the balloons maintain the required pressure.

[0031] It is advisable to design the balloon(s) as low-pressure cuffs and to provide pressure limiters in the inflation lumen(s) to limit the pressure to a low level for safety reasons. The valve is preferably an umbrella valve.

[0032] Common materials can be used for the balloons and catheter. These are medically approved plastics, such as PVC, polyamide, polyethylene, polypropylene, and the like. The materials should be sufficiently elastic to allow insertion into the Eustachian tube.

[0033] According to a second embodiment, ear catheters are conceivable with a tube as a catheter tube with a distal and a proximal end comprising a first lumen as an application lumen and a second lumen as an inflation lumen.

[0034] This design is essentially the same as the first variant, except that a pressure relief lumen is omitted. This is possible because this variant does not include a second, more proximal sealing element, and any excess pressure that may build up in the middle ear can be relieved through the existing incision in the eardrum.

[0035] Accordingly, all statements and explanations relating to the first embodiment also apply to this second embodiment, insofar as they relate in particular to the application lumen, the inflation lumen and the first or distal sealing element.

[0036] According to a third embodiment, variants of the ear catheter are conceivable with a tube as a catheter tube with a distal and a proximal end comprising a first lumen as an application lumen and an additional application device.

[0037] In this variant, the application lumen is not primarily intended for the direct administration of medication, but rather for receiving and placing the application device. The application lumen runs through the catheter tube from its proximal end to the application area, where it opens to the outside. The opening of the application lumen is preferably located at the distal end of the application lumen, or the open distal end of the application lumen forms this opening. This makes it possible to advance the application device through the application lumen to the application site, for example, in the middle ear.

[0038] Even if the application lumen in the case of this third embodiment is not primarily intended for the direct application of a medication and preferably does not have a corresponding closure, the application lumen can still optionally be suitable for the application of a medication, for example in order to supply further medication to the application element, which will be described further below.

[0039] The application device can be designed in different ways, but usually comprises a tubular or wire-shaped feed element, for example in the form of a feed wire or guide wire, and an application element provided distally on the feed element.

[0040] The application element can be attached to the feed element via a coupling element, whereby the coupling element can also be part of the feed element. Alternative embodiments are conceivable in which the application element itself is part of the feed element or is attached directly to the feed element without a special coupling element, for example, by gluing, welding, or other known joining techniques.

[0041] The delivery element can be made of any material, but the material must be sufficiently rigid to allow the delivery device to be advanced within the delivery lumen. Suitable materials from the medical technology field are known to those skilled in the art.

[0042] The distal end of the application, delivery, or coupling element should be atraumatic to avoid injury to the sensitive middle ear area during placement. The distal end of the ear catheter itself should also be atraumatic to avoid injury during placement of the ear catheter.

[0043] The application element is the actual carrier of the medication to be administered and serves to administer and deposit the medication in the middle ear region. The application element is therefore suitable for absorbing and subsequently releasing the medication to be administered.

[0044] Possible designs and materials for the application element can include woven textiles or nonwoven fleece fabrics, structures made of shape-memory materials or polymers such as wire mesh or coils, as well as combinations of the aforementioned designs and materials. Application elements are therefore all structures suitable for absorbing a medication, then making it available for application, and delivering it to the middle ear, at least for a certain period of time.

[0045] Structures according to the invention made of shape memory materials or polymers can also be, for example, wires, strands, braided threads, or spirals suitable for absorbing a substantially liquid or pasty medication. It is also conceivable for such braids or spirals to be directly coated with a medication or a medication-carrying coating, for example, in the form of a specific coating that carries the medication or in which the medication is embedded.

[0046] Other suitable combinations for such an application element are, for example, wires, braids or spirals provided with a textile cover or fleece or a sponge-like or porous plastic.

[0047] Textiles or fleece or spongy or porous plastics are also conceivable as application elements, which may additionally be arranged in a type of cage, whereby this cage is formed, for example, from shape memory materials or materials with shape memory properties.

[0048] Drug-coated balloons or drug-releasing balloon reservoirs are also conceivable application elements.

[0049] Depending on the type of application element, the application lumen can also be used to supply new medication to the application element. This is useful for application elements that can hold new medication in the manner of a reservoir. For example, application elements with sponge-like properties, balloons, or braids. 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 lamellae, which are preferably arranged in a ring shape distal to the application element and are designed to be flexible enough to form a fluid-tight seal between the application area and the oropharynx.

[0050] Such a lamellar sealing element can assume a compressed state in the application lumen and an expanded state upon release around the middle ear, which has a larger diameter than the compressed state.

[0051] Such a design of the distal sealing element with a lamellar structure can lead to complications when removing the ear catheter through the eardrum, since in particular a lamellar distal sealing element may not be easily converted from the expanded state back into the compressed state and thus retracted into the application lumen.

[0052] Accordingly, in embodiments, particularly with a lamella-like distal sealing element, a preferably thread-like or wire-like retrieval element is optionally provided at the distal end of the ear catheter, by means of which the ear catheter can alternatively also be removed through the oropharyngeal space.

[0053] For the balloons and catheters of all embodiments, conventional materials can be used, as are known in medical technology for catheters or for balloon catheter technology. These include, in particular, medically approved plastics, such as PVC, polyamide, polyethylene, polypropylene, and the like. The materials should be sufficiently elastic to allow insertion into the middle ear through the eardrum. The ear catheter according to the invention is particularly suitable for introducing antibiotic solutions through the eardrum into the middle ear region, which is useful in persistent bacterial infections. The standard treatment for sudden hearing loss, which involves a corticosteroid, can also be usefully performed using such an ear catheter.

[0054] The ear catheter according to the invention, in all variants and designs, enables a much more intensive and shorter treatment duration due to the continuous delivery of the active ingredient, often in a single treatment, even for patients for whom access is not possible through the nasopharynx but must be achieved through the eardrum. This significantly shortens the treatment duration for such patients, potentially down to just a few days.

[0055] Anti-inflammatory medications can also be administered through the ear catheter.

[0056] After the treatment, the ear catheter can be removed from the ear - if necessary after pressure relief and deflation of the balloons.

[0057] The ear catheter also allows for the treatment of inner ear diseases, as medications can usually pass through the membrane of the round window to the inner ear. This process is a diffusion process.

[0058] The invention also relates to a method for administering a medicament by means of an ear catheter according to the invention through the eardrum into the middle ear, comprising the following steps:

[0059] (A) Incision of the eardrum; and

[0060] (B) Inserting an ear catheter according to the invention through the incision in the eardrum; and (C) Placing the ear catheter in the middle ear; and

[0061] (D) optionally inflating the first and / or second sealing element; and

[0062] (E) if necessary, administering the medicament or inserting the delivery device through the delivery lumen; and

[0063] (F) if necessary, administer further medication through the application lumen; and

[0064] (G) optionally deflating the first and / or second sealing element; and

[0065] (H) if necessary, carry out additional pressure relief; and

[0066] (I) Removal of the ear catheter

[0067] The invention and the technical environment are explained in more detail below with reference to the figures. It should be noted that the figures show a particularly preferred embodiment of the invention. However, the invention is not limited to the embodiment shown. In particular, the invention encompasses, to the extent technically feasible, any combination of the technical features listed in the claims or described in the description as relevant to the invention.

[0068] They show:

[0069] Fig. 1 the access for an inventive

[0070] Ear catheter through an incision in the eardrum;

[0071] Fig. 2 shows a first embodiment of the ear catheter according to the invention; Fig. 3 shows the first embodiment of the ear catheter according to the invention with an alternative selection of the second sealing element;

[0072] Fig. 4 shows the second embodiment of the ear catheter according to the invention with only a first sealing element;

[0073] Fig. 5 the third embodiment of the ear catheter according to the invention without sealing elements but with an application element

[0074] Fig. 6 a variant of the third embodiment of the ear catheter according to the invention with a first sealing element

[0075] Figure 1 shows schematically the human ear with the eardrum T and the location of the incision E for inserting the ear catheter according to the invention.

[0076] Figure 2 shows a first embodiment of the ear catheter 1 according to the invention, comprising a catheter tube 2 with an application lumen 3, an inflation lumen 4, and a pressure relief lumen 5. The catheter tube 2 has an atraumatically shaped tip 8 at its distal end to prevent injury to the sensitive middle ear during placement of the ear catheter 1. A first sealing element 6 in the form of an inflatable balloon is provided at the distal end of the catheter tube 2 and is fluid-permeably connected to the inflation lumen 4. Further proximally, and when placed outside the middle ear in the external auditory canal, a second sealing element 7 in the form of an inflatable balloon is provided, which is also fluid-permeably connected to the inflation lumen 4. In an alternative embodiment, a separate inflation lumen 4 can be provided for each of the sealing elements 6, 7.The first and second sealing elements 6, 7 form an application area AB into which an active ingredient can be applied via the application lumen 3 through an opening 3a of the application lumen 3 into the application area AB. The overpressure in the application area AB resulting from the application of the active ingredient is compensated by an opening 5a in the pressure relief lumen 5. To prevent any active ingredient from escaping through the application lumen 3 or the pressure relief lumen 5, these lumens can include corresponding valves.

[0077] Figure 3 shows a second embodiment of the ear catheter 1 according to the invention, comprising a catheter tube 2 with an application lumen 3, an inflation lumen 4, and a pressure relief lumen 5. The catheter tube 2 has an atraumatically shaped tip 8 at its distal end to prevent injury to the sensitive middle ear during placement of the ear catheter 1. A first sealing element 6 in the form of an inflatable balloon is provided at the distal end of the catheter tube 2 and is fluid-permeably connected to the inflation lumen 4.

[0078] Further proximally, and when placed outside the middle ear in the external auditory canal, a second sealing element 7 is provided in the form of a closure arranged in a ring around the catheter tube 2. This second sealing element 7 is preferably made of silicone or another sealing yet flexible material. The diameter of this second sealing element 7 is selected such that at least a positive fit is achieved between the second sealing element 7 and the external auditory canal. In this embodiment, this second sealing element 7 can also comprise several serial ring- or disc-shaped elements, as shown.

[0079] In this embodiment, the first and second sealing elements 6, 7 also form an application area AB into which an active ingredient can be applied via the application lumen 3 through an opening 3a of the application lumen 3 into the application area AB. The overpressure in the application area AB resulting from the application of the active ingredient is compensated by an opening 5a in the pressure relief lumen 5. To prevent any active ingredient from escaping through the application lumen 3 or the pressure relief lumen 5, these lumens can include corresponding valves.

[0080] Figure 4 shows a third embodiment of the ear catheter 1 according to the invention, comprising a catheter tube 2 with an application lumen 3 and an inflation lumen 4. The catheter tube 2 has an atraumatically shaped tip 8 at its distal end to prevent injury to the sensitive middle ear during placement of the ear catheter 1. A first sealing element 6 in the form of an inflatable balloon is provided at the distal end of the catheter tube 2, which is fluid-permeably connected to the inflation lumen 4. This embodiment furthermore does not comprise a second sealing element proximally.

[0081] In this embodiment, the application area AB is formed by the first sealing element 6 and the eardrum, whereby a second sealing element is omitted and excessive medication leakage from the eardrum is prevented by the most precise form fit possible between the catheter tube 2 and the eardrum incision. An active ingredient can be applied into the application area AB via the application lumen 3 through an opening 3a of the application lumen 3. The excess pressure created by the application of the active ingredient in the application area AB can escape through the incision in the eardrum. Thus, a pressure relief lumen can be omitted in the present case; a corresponding lumen 5.1 can optionally be used as a guidewire lumen. To prevent any active ingredient from escaping through the application lumen 3, the application lumen 3 can comprise a corresponding one-way valve, which is preferably arranged proximally.

[0082] Figure 5 shows a further embodiment of the ear catheter 1 according to the invention with a catheter tube 2 having an application lumen 3. This embodiment does not include any sealing elements, since the medication is administered using an application element 10, which is suitable for holding the medication over a longer period of time and delivering it to the middle ear. The application element 10 is provided at the distal end of a delivery element 9, with the aid of which the application element 10 can be advanced through the application lumen 3 to the application area AB. The application element 10 can, as shown here, be connected to the delivery element 9 via a coupling element 11. In the present case, the coupling element 11 is provided as a nitinol basket, which encloses the application element 10 and accordingly assumes a folded state within the application lumen 3 and a reversibly expanded state outside the application lumen 3.

[0083] In the illustrated embodiment, the application element 10 is provided as a sponge-like element suitable for absorbing a medication. The medication can optionally also be supplied to the application element 10 via the application lumen 3 after the application element 10 has been placed. This can be useful because the application element 10 also assumes a compressed state within the application lumen 3 and, accordingly, can only absorb a smaller amount of medication compared to the expanded state outside the application lumen 3.

[0084] In this embodiment, the application area AB essentially corresponds to the length of the application element 10, which delivers the medication to the middle ear.

[0085] Figure 6 shows a further embodiment of the ear catheter 1 according to the invention with a catheter tube 2 with an application lumen 3. This embodiment comprises a distal sealing element 6', which is formed by one or more lamellae, which are preferably arranged in a ring shape and distal to the application element 10 and are designed to be so flexible that they can seal the application area AB in a fluid-tight manner with respect to the oropharyngeal space.

[0086] The application element 10 is provided at the distal end of a delivery element 9, with the aid of which the application element 10 can be advanced through the application lumen 3 to the application area AB. As shown here, the application element 10 can be directly connected to the delivery element 9, for example, by gluing or other techniques.

[0087] In the illustrated embodiment, the application element 10 is provided as a sponge-like element suitable for absorbing a medication. The medication can optionally also be supplied to the application element 10 via the application lumen 3 after the application element 10 has been placed. This can be useful because the application element 10 also assumes a compressed state within the application lumen 3 and, accordingly, can only absorb a smaller amount of medication compared to the expanded state outside the application lumen 3.

[0088] In this embodiment, the application area AB essentially corresponds to the length of the application element 10, which delivers the medication to the middle ear.

[0089] Since the distal sealing element 6' in this embodiment is formed by one or more lamellae, it may be advisable to remove the ear catheter 1 not through the incision in the eardrum, but rather through the nasopharyngeal space. For this purpose, a retrieval element 12, for example in the form of a thread, is provided at the distal end of the catheter 1, by which the catheter 1 can be grasped and removed through the oropharyngeal space.

[0090] If necessary, it may also be useful to place this embodiment through the oropharyngeal space and to guide only the catheter tube 2 with the application lumen 3 for applying fresh medication through the eardrum.

[0091] 1 ear catheter

[0092] 2 catheter tubes

[0093] 3 application lumens (3a opening of the application lumen, application opening)

[0094] 4 inflation lumens

[0095] 5 Pressure relief lumens (5a Opening of the pressure relief lumen)

[0096] 6 first sealing element

[0097] 7 second sealing element 8 atraumatic tip

[0098] 9 Feed element

[0099] 10 Application element

[0100] 11 Coupling element

[0101] 12 Retrieval element AB Application area p proximal d distal

Claims

Patent claims 1. An ear catheter for insertion into the middle ear region through an incision in the eardrum, comprising a catheter tube (2) with a distal (d) and a proximal (p) end, wherein the catheter tube (2) comprises at least three lumens, namely a first lumen as an application lumen (3), a second lumen as an inflation lumen (4), and a third lumen as a pressure relief lumen (5), and wherein the ear catheter (1) further comprises a first distal sealing element (6) and a second sealing element (7) located proximal to the first sealing element (6), wherein the sealing elements (6, 7) form an application region in the distal region of the catheter tube (2), and at least the first sealing element (6) is provided as an inflatable balloon which is connected to the inflation lumen (4) in a fluid-permeable manner.

2. Ear catheter according to claim 1, characterized in that the second sealing element (7) is provided as an inflatable balloon.

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

4. Ear catheter according to claim 1 or 2, characterized in that the catheter tube comprises a second inflation lumen and the second sealing element (7) is fluid-permeable to the second inflation lumen.

5. Ear catheter according to claim 1, characterized in that the second sealing element (7) is provided as a seal around the catheter tube.

6. Ear catheter according to claim 5, characterized in that the second sealing element (7) is provided displaceably along at least a part of the catheter tube (2).

7. An ear catheter for insertion into the middle ear region through an incision in the eardrum, comprising a catheter tube (2) with a distal (d) and a proximal (p) end, wherein the catheter tube (2) comprises only two lumens, namely a first lumen as an application lumen (3) and a second lumen as an inflation lumen (4), and wherein the ear catheter (1) further comprises only a first distal sealing element (6), and the first sealing element (6) is provided as an inflatable balloon which is connected to the inflation lumen (4) in a fluid-permeable manner.

8. Ear catheter according to one of the preceding claims, characterized in that the catheter tube (2) has an atraumatically shaped tip (8) at the distal end.

9. Ear catheter for insertion through the eardrum into the middle ear region, comprising a catheter tube (2) with a distal and a proximal end and an application device with a feed element (9) and an application element (10) provided distally on the feed element (9), wherein the catheter tube (2) comprises a lumen extending from proximal to distal as an application lumen (3), and wherein the application lumen (3) is provided for inserting the application device from the proximal end of the catheter tube (2) through the application lumen (3) to the distal end of the catheter tube (2).

10. Ear catheter according to claim 9, characterized in that the application element (10) is suitable for the application and deposition of a medication in the middle ear region and comprises woven textiles or non-woven fleece fabrics, structures made of shape memory materials or Polymers such as wire mesh or coils as well as combinations of the aforementioned designs and materials.

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