Improved ear catheter for applying medication

Abstract

The invention relates to an ear catheter for introducing into the eustachian tube, comprising a catheter tube (2) with at least three lumen, namely a first lumen as an application lumen (2a) for applying a medication, a second lumen as an inflation lumen (2b) for inflating a balloon (17), and a third lumen as a pressure-relieving lumen (2c) for relieving pressure in the central ear region. In order to prevent a flow of medication out of the application lumen (2a) and in order to prevent a flow of inflation fluid out of the inflation lumen (2b), a respective one-way valve (11, 12) is provided, and a pressure limiter (13) is provided in order to limit the pressure of the balloon.

Description

[0001] Improved ear catheter for drug administration

[0002] The invention relates to an ear catheter for transnasal or transmeatal introduction into the Eustachian tube, which allows a medication to be made available in the middle ear area even over a longer period of time without it flowing out via the Eustachian tube.

[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 via the Eustachian tube. Treatment of the inner ear can also be performed via the middle ear region.

[0004] 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.

[0005] The treatment of a number of infections and inflammations, such as sudden hearing loss, requires the long-term administration of medication into the Eustachian tube or middle ear, which can sometimes last for days or even 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.

[0006] 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.

[0007] The medication is administered non-invasively using the well-known ear catheter via the nasopharynx and the auditory tube (the Eustachian tube).

[0008] DE 10 2021 105 036 A1 also describes an ear catheter that can be inserted into the Eustachian tube via the nasopharynx. This application proposes an expandable coated nitinol basket or balloon to seal the nasopharynx.

[0009] However, existing ear catheters can still be improved in key details, especially when using an expandable balloon as a sealing element. With such a design, it is essential to provide a convincing valve arrangement that reliably prevents the development of undesirable overpressure in the ear when medication is administered and also prevents the involuntary outflow of medication from the ear.

[0010] The object of the invention is therefore to provide an ear catheter that is improved over the prior art, which does not have the known disadvantages and, in particular, reliably delivers medication to the middle ear while simultaneously preventing undesirable overpressure in the middle ear. This object is achieved by an invention having the features of claim 1. 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 technologically expedient manner, thus demonstrating further embodiments of the invention.

[0011] The ear catheter according to the invention for insertion into the Eustachian tube comprises a catheter tube with at least three lumens, namely a first lumen as an application lumen for applying a medication (this can alternatively also be used as a guidewire lumen if it ends open distally), a second lumen as an inflation lumen for inflating a distally provided inflatable balloon and a third lumen as a pressure relief lumen for pressure relief in the middle ear region.

[0012] The inflatable balloon is positioned distally on the ear catheter to seal the middle ear, preventing medication administered through the application lumen from flowing through the nasopharynx. The balloon should not be inflated to high pressure, as this could lead to injury or pressure sores in the sensitive middle ear. Low-pressure balloons (low-pressure cuffs) are recommended.

[0013] To limit the pressure in the balloon, a pressure limiter is provided, which preferably limits the pressure to below a slight overpressure. The pressure limiter is typically provided in the form of an umbrella valve.

[0014] The pressure limiter is preferably provided between the proximal end of the inflation lumen and the connection of the inflation lumen to the balloon. Preferably, the pressure limiter is provided in the proximal region of the ear catheter.

[0015] Known inflation fluids, typically physiological saline solutions, are used to inflate the balloon. The application lumen runs through the catheter tube from proximal to distal and ends distally with an opening. The inflation lumen runs through the catheter tube from proximal to distal and ends distally with a fluid-permeable connection in the balloon. The pressure release lumen runs from proximal to distal through the catheter tube and ends distally with an opening.

[0016] The distal tip of the ear catheter or catheter tube is preferably designed to be atraumatic.

[0017] At the proximal ends of the injection and inflation lumens, connectors are provided for connecting additional instruments, particularly syringes for administering the medication and inflation fluid. Standard connectors for the Luer-Lock system, widely used in medicine, are preferred.

[0018] In a first preferred embodiment of the ear catheter for placement through the nasopharynx, the application lumen and the pressure relief lumen in the distal region of the ear catheter each end with an opening distal to the balloon. The balloon seals the middle ear from the nasopharynx, and the medication is administered distally into the middle ear. In this embodiment, the application lumen is preferably located centrally in the catheter tube, while the two remaining lumens are arranged laterally.

[0019] In a second preferred embodiment of the ear catheter for placement through the eardrum, the application lumen and the pressure relief lumen in the distal region of the ear catheter each end with an opening proximal to the balloon. The balloon seals the middle ear from the nasopharynx, and the medication is administered into the middle ear proximal to the balloon. In this embodiment, all three lumens are preferably arranged laterally.

[0020] To assist with catheter or balloon placement, markers may be provided at the distal end of the catheter, proximal to the sealing element. Such markers can be provided sequentially and can be perceived endoscopically by the practitioner during placement.

[0021] It is advantageous to place several markers, for example, marking a first non-critical area of ​​advancement, a second area of ​​heightened attention, and a third critical area. The terms "non-critical," "heightened attention," and "critical" refer to the progressive penetration of the catheter tip into the inner ear and thus to an increasingly critical proximity to sensitive areas.

[0022] However, it is also conceivable that a non-sequential marker is provided, which, for example, covers a specific area in which the user should pay increased attention when placing it.

[0023] For the balloon, catheter, and injection channel, materials commonly used in balloon catheter technology can be used. These are medically approved plastics, such as PVC, polyethylene, polypropylene, and the like. The materials should be sufficiently elastic to allow the catheter to be inserted.

[0024] To prevent backflow of medication from the application lumen and to prevent backflow of inflation fluid from the inflation lumen, the ear catheter includes a one-way valve, wherein these valves are preferably provided at the proximal end of the ear catheter and at the proximal end of the respective lumens, respectively. The one-way valves are preferably provided as duckbill valves.

[0025] The administration of medication into the middle ear region sealed by a balloon inevitably creates excess pressure. A pressure relief lumen is provided to dissipate this pressure. To prevent medication from inadvertently flowing out through the pressure relief lumen, the outlet opening of the pressure relief lumen is sealed, preferably in the form of an umbrella valve. The outlet opening or the corresponding umbrella valve is preferably located in the proximal region of the ear catheter. The opening pressure of the second umbrella valve is preferably set to practically 0 bar, and the second umbrella valve essentially functions as a sealing element to prevent inadvertent flow of medication through the pressure relief lumen.

[0026] In the context of the invention, "proximal" refers to the area of ​​the ear catheter that faces the user during use, while "distal" refers to the area of ​​the ear catheter that faces away from the user during use. Further details regarding the positional relationships can be found in the figures.

[0027] In a preferred embodiment, the ear catheter comprises a frame construction with a first and a second frame element, wherein the two frame elements form the two halves of the frame construction and can be mounted to one another in a form-fitting and force-fitting manner with first and second fixing elements, for example hooks and complementary holes, etc.

[0028] The frame construction, together with an optional housing, forms the operating element of the ear catheter and is located at its proximal end.

[0029] The frame elements form a tubular receptacle for the proximal end of the catheter tube. The frame elements provide proximal access to the application lumen and the inflation lumen of the catheter tube.

[0030] To prevent the medication from flowing back from the application lumen or the inflation fluid from flowing back from the inflation lumen, one-way valves—preferably duckbill valves—are provided in the proximal access ports. To enable the connection of additional instruments to the access ports, first and second connection elements are also provided at the access ports, which preferably allow connection via a standard Luer lock. Along the catheter tube receptacle, there are preferably three compartmentalization boundaries, each of which divides a portion of the receptacle into one of the two compartments.

[0031] A first compartment, together with the inflation lumen of the catheter tube, forms a fluid-connected unit, which is connected to the pressure limiter or the first umbrella valve via a first connection. To vent the inflation lumen, an optional adapter element with a possibly hollow, tubular tip is provided, which can be used to open the proximal one-way valve.

[0032] A first recess in the frame is provided for the pressure limiter or the first umbrella valve. If the pressure in the inflation lumen, or in the combination of the inflation lumen and the first compartment, rises above a certain pressure, the first umbrella valve opens and inflation fluid exits the valve. This indicates to the user that the maximum permissible pressure has been reached.

[0033] The second compartment, together with the pressure relief lumen of the catheter tube, forms a fluid-connected unit, which is connected to the sealing element or the second umbrella valve via a second connection. A second recess is provided in the frame for the sealing element or the second umbrella valve. If the pressure in the pressure relief lumen or in the combination of the pressure relief lumen and the second compartment rises above a certain pressure, the second umbrella valve opens. The outflow of air or, if applicable, medication from this valve indicates to the user that too much medication may have been administered.

[0034] The frame construction with a first and a second frame element includes respective receptacles for the catheter tube, the one-way valves, the pressure limiter, and the sealing element. The preferred design with a frame construction has significant advantages. The formation of two self-contained compartments, each enclosing the essential components of pressure relief management—such as the pressure relief lumen, one-way valve, and sealing valve—and the essential components of inflation management—such as the inflation lumen, one-way valve, and pressure relief valve—is an extremely intelligent solution for the effective connection of these components.

[0035] The frame construction connects the three-lumen catheter tube to the respective accesses and closes them securely.

[0036] The frame construction also serves as a handling aid and allows safe handling of the ear catheter.

[0037] The frame construction can also be protected by an additional, possibly also double-shelled housing, which offers more comfortable handling and protection of the frame construction.

[0038] The ear catheter according to the invention is particularly suitable for administering antibiotic solutions into the middle ear region, which is useful for persistent bacterial infections. The standard treatment for sudden hearing loss, which involves a corticosteroid, can also be effectively administered via such an ear catheter. Standard therapy requires the administration of such a corticosteroid over an extended period, usually about two weeks, with daily reapplication necessary because the medication drains into the nasopharynx. A treatment duration of 14 days is typical. The ear catheter according to the invention enables much more intensive and shorter treatment because it ensures the constant presence of the medication. The treatment duration is thus considerably shortened, potentially down to just a few days. It is particularly suitable for retaining the medication in the middle ear for an extended period, especially several days.

[0039] The ear catheter remains in the middle ear during treatment, keeping the administered medication in that area without allowing it to drain into the nasopharynx. This allows the patient to remain mobile, eliminates the need for extended hospital stays, and regular medical monitoring is sufficient. Ear microscopy can be used for monitoring.

[0040] 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.

[0041] They show:

[0042] Fig. 1 an exploded view of the proximal

[0043] Part of the preferred embodiment of the ear catheter in a first perspective view

[0044] Fig. 2 an exploded view of the proximal

[0045] Part of the preferred embodiment of the ear catheter in a second perspective view The inside of the first

[0046] frame element The outside of the first

[0047] frame element The inside of the second

[0048] frame element

[0049] Fig. 6 The outside of the second

[0050] Frame element Fig. 7 The inside of the first

[0051] Frame element in a perspective view

[0052] Fig. 8 The inside of the second

[0053] Frame element in a perspective view

[0054] Fig. 9 the distal part of the preferred

[0055] Design of the ear catheter

[0056] Fig. 10 the distal end of the catheter tube of the preferred embodiment of the ear catheter

[0057] Fig. 11 the proximal end of the

[0058] Catheter tube of the preferred embodiment of the ear catheter

[0059] Fig. 12A-C Cross sections through alternative embodiments of the catheter tube

[0060] Figure 1 shows an exploded view of the proximal part 1p of the preferred embodiment of the ear catheter in a first perspective view. Not shown is the distal part 1d of the ear catheter, as shown below in Figure 9. The proximal part 1p of the ear catheter comprises a catheter tube 2 embedded in a frame structure with a first frame element 3 and a second frame element 4. The frame elements 3, 4 can optionally be enclosed by a first cover element 5 and a second cover element 6.

[0061] Access ports 7, 8 are provided on the frame elements 3, 4, one leading to the application lumen and the other leading to the inflation lumen of the catheter tube 2. To prevent the medication from flowing back from the application lumen or the inflation fluid from flowing back from the inflation lumen, one-way valves 11, 12—preferably duckbill valves—are provided in the proximal access ports 7, 8. To enable the connection of additional instruments to the access ports 7, 8, first and second connection elements 9, 10 are also provided at the access ports 7, 8, which preferably enable connection via a standard Luer lock.

[0062] In order to limit the pressure in the balloon (not shown, see Figure 9), an overpressure limiter 13 - preferably in the form of a first umbrella valve - is provided between the proximally arranged one-way valve 12 and the distally arranged balloon and is fluid-permeable to the inflation lumen.

[0063] In order to compensate for the excess pressure created in the ear by the application of medication, a pressure relief lumen is provided which is in fluid-permeable connection with a sealing element 14 - preferably in the form of a second umbrella valve.

[0064] In this preferred embodiment shown, the frame elements 3, 4 are provided such that all valves 11, 12, 13, 14, the catheter tube and all necessary fluid-permeable connections between catheter tube 2 and valves 11, 12, 13, 14 are accommodated therein.

[0065] In order to vent the inflation lumen, an optional adapter element 16 with a possibly hollow tip is provided, with the aid of which the proximal one-way valve 12 can be opened.

[0066] Figure 2 shows an alternative perspective view of the exploded drawing of the proximal part 1p of the preferred embodiment of the ear catheter. Not shown is the distal part 1d of the ear catheter, as shown below in Figure 9. The proximal part 1p of the ear catheter comprises a catheter tube 2 embedded in a frame construction with a first frame element 3 and a second frame element 4. The frame elements 3, 4 can optionally be enclosed by a first cover element 5 and a second cover element 6. Access ports 7, 8 are provided on the frame elements 3, 4, one for the application lumen and the other for the inflation lumen of the catheter tube 2. In order to prevent a backflow of the medication from the application lumen or a backflow of the inflation fluids from the inflation lumen, one-way valves 11, 12 - preferably duckbill valves - are provided in the proximal accesses 7, 8.In order to enable the connection of further instruments to the accesses 7, 8, first and second connection elements 9, 10 are also provided at the accesses 7, 8, which preferably enable the connection via a standard Luer lock.

[0067] In order to limit the pressure in the balloon (not shown, see Figure 9), an overpressure limiter 13 - preferably in the form of a first umbrella valve - is provided between the proximally arranged one-way valve 12 and the distally arranged balloon and is fluid-permeable to the inflation lumen.

[0068] In order to compensate for the excess pressure created in the ear by the application of medication, a pressure relief lumen is provided which is in fluid-permeable connection with a sealing element 14 - preferably in the form of a second umbrella valve.

[0069] In this preferred embodiment shown, the frame elements 3, 4 are provided such that all valves 11, 12, 13, 14, the catheter tube and all necessary fluid-permeable connections between catheter tube 2 and valves 11, 12, 13, 14 are accommodated therein.

[0070] In order to vent the inflation lumen, an optional adapter element 16 with a possibly hollow tip is provided, with the aid of which the proximal one-way valve 12 can be opened.

[0071] Figure 3 shows the inside of the first frame element 3 with the proximal accesses to the application lumen 7 and the inflation lumen 8. The first frame element 3 further comprises a receptacle 202 for the catheter tube. Along the receptacle 202 there are three compartmentalization boundaries I, II, III, which divide a part of the receptacle 202 into two compartments A, B. The compartmentalization boundaries I and II form compartment A and the compartmentalization boundaries II and III form compartment B. The compartment A, together with the inflation lumen of the catheter tube, forms a fluid-connected unit which is connected to the pressure limiter or the first umbrella valve via a first connection 8a, wherein a first recess 13a is provided in the frame element 3 for the pressure limiter or the first umbrella valve.If the pressure in the inflation lumen or in the combination of the inflation lumen and compartment A exceeds a certain pressure, the first umbrella valve opens. The inflation pressure is preferably limited to a slight overpressure by the first umbrella valve.

[0072] Compartment B, together with the pressure relief lumen of the catheter tube, forms a fluid-connected unit, which is connected to the sealing element or the second umbrella valve via a second connection 15. A second recess 14a is provided in the frame element 3 for the sealing element or the second umbrella valve. If the pressure in the pressure relief lumen or in the combination of pressure relief lumen and compartment B rises above a certain pressure, the second umbrella valve opens. Preferably, the opening pressure of the second umbrella valve is set to practically 0 bar, and the second umbrella valve functions as a sealing element.

[0073] Figure 4 shows the outside of the first frame element 3 with the proximal accesses to the application lumen 7 and the inflation lumen 8. The first frame element 3 further comprises a receptacle 202 for the catheter tube. Along the receptacle 202 there are three accesses to the compartmentalization boundaries I, II, III, which divide a part of the receptacle 202 into two compartments A, B. The compartmentalization boundaries I and II form compartment A and the compartmentalization boundaries II and III form compartment B. The compartment A, together with the inflation lumen of the catheter tube, forms a fluid-connected unit which is connected to the pressure limiter or the first umbrella valve via a first connection 8a, wherein a first recess 13a is provided in the frame element 3 for the pressure limiter or the first umbrella valve.If the pressure in the inflation lumen or in the combination of the inflation lumen and compartment A exceeds a certain pressure, the first umbrella valve opens. The inflation pressure is preferably limited to a slight overpressure by the first umbrella valve.

[0074] Compartment B forms a fluid-connected unit together with the pressure relief lumen of the catheter tube.

[0075] Figure 5 shows the inside of the second frame element 4 with the proximal accesses to the application lumen 7 and the inflation lumen 8. The second frame element 4 further comprises a receptacle 202 for the catheter tube. Along the receptacle 202 there are three compartmentalization boundaries I, II, III, which divide a part of the receptacle 202 into two compartments A, B. The compartmentalization boundaries I and II form compartment A and the compartmentalization boundaries II and III form compartment B. The compartment A, together with the inflation lumen of the catheter tube, forms a fluid-connected unit which is connected to the pressure limiter or the first umbrella valve via a first connection 8a, wherein a first recess 13a is provided in the frame element 4 for the pressure limiter or the first umbrella valve.If the pressure in the inflation lumen or in the combination of the inflation lumen and compartment A exceeds a certain pressure, the first umbrella valve opens. The inflation pressure is preferably limited to a slight overpressure by the first umbrella valve.

[0076] Compartment B, together with the pressure relief lumen of the catheter tube, forms a fluid-connected unit, which is connected to the sealing element or the second umbrella valve via a second connection 15. A second recess 14a is provided in the frame element 4 for the sealing element or the second umbrella valve. If the pressure in the pressure relief lumen or in the combination of pressure relief lumen and compartment B rises above a certain pressure, the second umbrella valve opens. Preferably, the opening pressure of the second umbrella valve is set to practically 0 bar, and the second umbrella valve functions as a sealing element.

[0077] Figure 6 shows the outside of the second frame element 4 with the proximal accesses to the application lumen 7 and the inflation lumen 8. The second frame element 4 further comprises a receptacle 202 for the catheter tube. Along the receptacle 202 there are three accesses to the compartmentalization boundaries I, II, III, which divide a part of the receptacle 202 into two compartments A, B. The compartmentalization boundaries I and II form compartment A and the compartmentalization boundaries II and III form compartment B. The compartment A, together with the inflation lumen of the catheter tube, forms a fluid-connected unit which is connected via a first connection to the pressure limiter or the first umbrella valve, wherein a first recess 13a is provided in the frame element 4 for the pressure limiter or the first umbrella valve.If the pressure in the inflation lumen or in the combination of the inflation lumen and compartment A exceeds a certain pressure, the first umbrella valve opens. The inflation pressure is preferably limited to a slight overpressure by the first umbrella valve.

[0078] The compartment B forms a fluid-connected unit together with the pressure relief lumen of the catheter tube and is connected to the sealing element or the second umbrella valve, wherein a second recess 14a is provided in the frame element 4 for the sealing element or the second umbrella valve.

[0079] Figure 7 shows a perspective view of the inside of the first frame element 3 with the proximal accesses to the application lumen 7 and the inflation lumen 8. The first frame element 3 further comprises a receptacle 202 for the catheter tube. Along the receptacle 202 there are three compartmentalization boundaries I, II, III, which divide a part of the receptacle 202 into two compartments A, B. The compartmentalization boundaries I and II form compartment A and the compartmentalization boundaries II and III form compartment B. The compartment A, together with the inflation lumen of the catheter tube, forms a fluid-connected unit which is connected to the pressure limiter or the first umbrella valve via a first connection 8a, wherein a first recess 13a is provided in the frame element 3 for the pressure limiter or the first umbrella valve.If the pressure in the inflation lumen or in the combination of the inflation lumen and compartment A exceeds a certain pressure, the first umbrella valve opens. The inflation pressure is preferably limited to a slight overpressure by the first umbrella valve.

[0080] Compartment B, together with the pressure relief lumen of the catheter tube, forms a fluid-connected unit, which is connected to the sealing element or the second umbrella valve via a second connection 15. A second recess 14a is provided in the frame element 3 for the sealing element or the second umbrella valve. If the pressure in the pressure relief lumen or in the combination of pressure relief lumen and compartment B rises above a certain pressure, the second umbrella valve opens. Preferably, the opening pressure of the second umbrella valve is set to practically 0 bar, and the second umbrella valve functions as a sealing element.

[0081] The first frame element 3 further comprises at least one first fixing element 18, preferably in the form of a hook element 18a, and at least one second fixing element 19, preferably in the form of a circular element 19a, for fixing the first frame element 3 to corresponding complementary fixing elements of the second frame element 4.

[0082] Figure 8 shows a perspective view of the inside of the second frame element 4 with the proximal accesses to the application lumen 7 and the inflation lumen 8. The second frame element 4 further comprises a receptacle 202 for the catheter tube. Along the receptacle 202 there are three compartmentalization boundaries I, II, III, which divide a part of the receptacle 202 into two compartments A, B. The compartmentalization boundaries I and II form compartment A and the compartmentalization boundaries II and III form compartment B. The compartment A, together with the inflation lumen of the catheter tube, forms a fluid-connected unit which is connected to the pressure limiter or the first umbrella valve via a first connection 8a, wherein a first recess 13a is provided in the frame element 4 for the pressure limiter or the first umbrella valve.If the pressure in the inflation lumen or in the combination of the inflation lumen and compartment A exceeds a certain pressure, the first umbrella valve opens. The inflation pressure is preferably limited to a slight overpressure by the first umbrella valve.

[0083] Compartment B, together with the pressure relief lumen of the catheter tube, forms a fluid-connected unit, which is connected to the sealing element or the second umbrella valve via a second connection 15. A second recess 14a is provided in the frame element 4 for the sealing element or the second umbrella valve. If the pressure in the pressure relief lumen or in the combination of pressure relief lumen and compartment B rises above a certain pressure, the second umbrella valve opens. Preferably, the opening pressure of the second umbrella valve is set to practically 0 bar, and the second umbrella valve functions as a sealing element.

[0084] The second frame element 4 further comprises at least one first fixing element 18, preferably in the form of a first hole element 18b, and at least one second fixing element 19, preferably in the form of a second hole element 19b, for fixing the second frame element 4 to corresponding complementary fixing elements of the first frame element 3.

[0085] Figure 9 shows a perspective view of the distal end 1d of the ear catheter with the catheter tube 2 and the inflated balloon 17 attached to it. The outlet openings of the central application lumen 2a and the lateral pressure relief lumen 2c can be seen at the distal tip of the catheter tube 2. The distal tip 20 of the catheter tube 2 is preferably designed to be atraumatic.

[0086] Figure 10 shows a perspective view of the distal end of the catheter tube 2 without the balloon. The outlet openings of the central application lumen 2a and the lateral pressure relief lumen 2c can be seen at the distal tip of the catheter tube 2. Further proximally, an opening 2b1 of the lateral inflation lumen is provided, which connects the inflation lumen to the balloon for its inflation. The distal tip 20 of the catheter tube 2 is preferably designed to be atraumatic.

[0087] Figure 11 shows a perspective view of the proximal end of the catheter tube 2. The openings of the central application lumen 2a, the lateral inflation lumen 2b, and the lateral pressure relief lumen 2c can be seen at the proximal end of the catheter tube 2. Further distally, an opening 2b2 of the inflation lumen 2b is provided, which connects the inflation lumen 2b to the pressure limiter or the first umbrella valve.

[0088] Figure 12 shows three perspective views of the proximal end of the catheter tube 2 in alternative embodiments A to C for ear catheters whose application lumen 2a and pressure relief lumen 2c end proximal to the balloon, rather than distally. Accordingly, it is advantageous that none of the lumens 2a, 2b, 2c is provided centrally, as in Figures 9 to 11, for example.

[0089] At the proximal end of the catheter tube 2, the openings of the application lumen 2a, the inflation lumen 2b, and the pressure relief lumen 2c can be seen, whereby the occupancy of the lumens can ultimately be determined according to the specific needs of the catheter design.

[0090] 1 ear catheter (1p: proximal part; 1d: distal part)

[0091] 2 Catheter tube (2a: application lumen; 2b: inflation lumen; 2b1: distal opening; 2b2: proximal opening; 2c: pressure relief lumen) 202 Receptacle for the catheter tube

[0092] 3 First frame element / first frame

[0093] 4 Second frame element / second frame

[0094] 5 First cover element

[0095] 6 Second cover element 7 Access application lumen

[0096] 8 Access inflation lumen (8a: first connection)

[0097] 9 First connection element (Luer-Lock)

[0098] 10 Second connection element (Luer-Lock)

[0099] 11 First duckbill valve 12 Second duckbill valve 13 First umbrella valve (pressure limiter; 13a: first recess)

[0100] 14 Second umbrella valve (sealing element; 14a: second recess)

[0101] 15 Second connection

[0102] 16 adapter element

[0103] 17 Balloon

[0104] 18 First fixing elements (18a: hook element; 18b: first hole element)

[0105] 19 Second fixing elements (19a: circular element; 19b: second hole element)

[0106] 20 Atraumatic tip

[0107] A First compartment (inflation lumen)

[0108] B Second compartment (pressure relief lumen)

[0109] I First compartmentalization boundary

[0110] II Second compartmentalization boundary

[0111] III Third compartmentalization boundary

Claims

Patent claims 1. An ear catheter for insertion into the Eustachian tube, comprising a catheter tube (2) with at least three lumens, namely a first lumen as an application lumen (2a) for applying a medication, a second lumen as an inflation lumen (2b) for inflating the distally provided inflatable balloon (17), and a third lumen as a pressure relief lumen (2c) for relieving pressure in the middle ear region, characterized in that a one-way valve (11, 12) is provided to prevent a backflow of medication from the application lumen (2a) and to prevent a backflow of inflation fluid from the inflation lumen (2b), and a pressure limiter (13) is provided to limit the pressure of the balloon.

2. Ear catheter according to claim 1, characterized in that the application lumen (2a) and the pressure relief lumen (2c) each have an opening distal to the balloon (17).

3. Ear catheter according to claim 1, characterized in that the application lumen (2a) and the pressure relief lumen (2c) each end with an opening proximal to the balloon (17).

4. Ear catheter according to one of the preceding claims, characterized in that the pressure relief lumen (2c) comprises a sealing element (14).

5. Ear catheter according to claim 4, characterized in that the sealing element (14) is provided as an umbrella valve.

6. Ear catheter according to one of the preceding claims, characterized in that the pressure limiter (13) is provided as an umbrella valve.

7. Ear catheter according to one of the preceding claims, characterized in that the one-way valves (11, 12) are provided as duckbill valves.

8. Ear catheter according to one of the preceding claims, characterized in that the ear catheter comprises a frame construction with a first and a second frame element (3, 4) and wherein receptacles (7, 8, 13a, 14a, 202) for the catheter tube (2) for the one-way valves (11, 12), the pressure limiter (13) and the sealing element (14) are provided in the frame elements (3, 4).

9. Ear catheter according to claim 8, characterized in that the frame elements (3, 4) comprise at least two compartments (A, B), namely a compartment (A) for the inflation lumen (2a) and a compartment (B) for the pressure relief lumen (2c).

10. Ear catheter according to claim 9, characterized in that the at least two compartments (A, B) are delimited by at least three compartment boundaries (I, II, III), namely the compartment (A) by two compartment boundaries (I, II) the compartment (B) by two compartment boundaries (II, III).

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