Improved ear catheter for administering medications

Abstract

The present invention relates to an ear catheter for insertion into the Eustachian canal, comprising a catheter tube (2) with at least three lumens: a first lumen as an administration lumen (2a) for administering a drug, a second lumen as an inflation lumen (2b) for inflating a distally disposed inflatable balloon (17), and a third lumen as a pressure relief lumen (2c) for relieving pressure in the middle ear region. One-way valves (11, 12) are provided to prevent backflow of drug from the administration lumen (2a) and inflation fluid from the inflation lumen (2b), and a pressure limiting device (13) is provided to limit the pressure in the balloon.

Description

[Technical Field]

[0001] The present invention relates to an ear catheter for transnasal or transcanal insertion into the Eustachian tube, which allows for the delivery of medication to the middle ear region over an extended period of time without leakage through the Eustachian tube. [Background technology]

[0002] There are many known diseases of the middle and inner ear that require localized treatment. When localized 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.

[0003] For therapeutic purposes, ear catheters inserted through the nose are also often used to introduce medications. However, administration of medications, especially in liquid form, into the Eustachian tube or middle ear is often short-lived, as the medication usually drains into the nasopharynx shortly after administration.

[0004] Treatment of various infections and inflammations, such as hearing loss, 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.

[0005] 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.

[0006] 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.

[0007] The administration of drugs using known ear catheters is carried out non-invasively via the nasopharynx and the Eustachian tube.

[0008] Patent document 2 similarly describes an ear catheter that can be inserted into the Eustachian tube via the nasopharynx. To seal from the nasopharynx, the application proposes an expandable coated nitinol basket or balloon.

[0009] However, important details of known ear catheters can be improved, especially when an expandable balloon is used as the sealing element, since in such configurations it is important to provide a reliable valve arrangement that reliably avoids the creation of undesired overpressure in the ear after the drug has been administered, as well as preventing the drug from indiscriminately escaping from the ear. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] German Patent Application Publication No. 102018102937 [Patent Document 2] German Patent Application Publication No. 102021105036 Summary of the Invention [Problem to be solved by the invention]

[0011] The problem solved by the present invention is to provide an improved ear catheter compared to the prior art, which does not have the known drawbacks and in particular ensures the delivery of medication to the middle ear while at the same time preventing undesired overpressure in the middle ear. [Means for solving the problem]

[0012] This problem is solved by the present invention with the features of claim 1. 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.

[0013] The ear catheter according to the invention for insertion into the Eustachian canal comprises a catheter tube having at least three lumens: a first lumen in the form of an administration lumen for administering a drug (which, if open at the distal end, can alternatively be used as a guidewire lumen), a second lumen in the form of an expansion lumen for expanding a distally provided expandable balloon, and a third lumen in the form of a pressure release lumen for releasing pressure in the middle ear region.

[0014] An expandable balloon is provided at the distal end of the ear catheter to seal the middle ear, preventing medication administered through the administration lumen from escaping through the nasopharynx. High pressure should not be applied to the balloon, as this may cause damage or pressure ulcers to the sensitive middle ear. The use of a low-pressure balloon (low-pressure cuff) is also considered.

[0015] In order to limit the pressure in the balloon, a pressure limiting device is suitably provided, which preferably limits the pressure below a low overpressure, in particular in the form of an umbrella valve.

[0016] A pressure limiting device is preferably provided between the proximal end of the inflation lumen and the connection of the inflation lumen to the balloon, preferably in the proximal region of the ear catheter.

[0017] To expand the balloon, a known inflation fluid is used, typically saline.

[0018] The administration lumen extends through the catheter tube from the proximal end to the distal end and terminates distally in an opening, the inflation lumen extends through the catheter tube from the proximal end to the distal end and terminates distally in a fluid-permeable connection within the balloon, and the pressure release lumen extends through the catheter tube from the proximal end to the distal end and terminates distally in an opening.

[0019] The distal tip of the ear catheter or catheter tube is preferably designed to be atraumatic.

[0020] Connections for connecting further instruments, in particular syringes for introducing medications and inflation fluids, are provided at the proximal ends of the infusion and inflation lumens. Preferably, these are standard connections for the Luer Lock system, which is widely used in medicine.

[0021] In a first preferred embodiment of an ear catheter for placement through the nasopharynx, the administration lumen and the pressure release lumen each terminate in the distal region of the ear catheter at an opening at the distal end of a balloon. The balloon seals the middle ear from the nasopharynx, allowing the drug to be administered distally into the middle ear. In this embodiment, the administration lumen is preferably located in the center of the catheter tube, and the other two lumens are located laterally.

[0022] In a second preferred embodiment of an ear catheter for placement through the tympanic membrane, the administration lumen and pressure release lumen each terminate in the distal region of the ear catheter at an opening at the proximal end of a balloon. The balloon seals the middle ear from the nasopharynx, and the drug is administered into the middle ear at the proximal end of the balloon. In this embodiment, all three lumens are preferably arranged laterally.

[0023] To aid in placement of the catheter or balloon, markings can be provided on the distal end of the catheter but proximal end of the sealing element. Such markings, or markers, can in turn be provided and can be detected during placement by the person providing the treatment using the endoscope.

[0024] For example, it may be advantageous to apply multiple markers marking a first non-critical region of forward movement, a second region of increased attention, and a third critical region, the terms "non-critical," "increased attention," and "critical" relating to the continued penetration of the catheter tip into the inner ear and, therefore, increasingly significant proximity to sensitive regions.

[0025] However, it is also conceivable to provide a non-continuous marker, which for example covers a predetermined area where the user should pay close attention during placement.

[0026] For the balloon, catheter, and infusion channel, conventional materials standard in balloon catheter technology can be used, such as medically approved plastic materials, such as PVC, polyethylene, polypropylene, etc. The material must be sufficiently elastic to allow insertion of the catheter.

[0027] To prevent backflow of medication from the administration lumen and inflation fluid from the inflation lumen, the ear catheter is provided with one-way valves for each lumen, preferably at the proximal end of the ear catheter and at the proximal end of each lumen, and the one-way valves are preferably in the form of duckbill valves.

[0028] The administration of a drug to the middle ear region sealed by the balloon inevitably creates an overpressure. To overcome this, a pressure relief lumen is provided. A seal, preferably in the form of an umbrella valve, is provided at the outlet opening of the pressure relief lumen to prevent the drug from indiscriminately escaping through the pressure relief lumen. The outlet opening and the corresponding umbrella valve are preferably provided in the proximal region of the ear catheter. Preferably, the opening pressure of the second umbrella valve is set to substantially 0 bar, and the second umbrella valve essentially functions as a sealing element to prevent the drug from indiscriminately escaping through the pressure relief lumen.

[0029] In the context of the present invention, "proximal" means the area of ​​the ear catheter that is closest to the user when in use, and "distal" means the area of ​​the ear catheter that points away from the user when in use. Further details regarding positional relationships can be seen in the drawings.

[0030] In a preferred embodiment, the ear catheter comprises a frame structure including first and second frame elements, the two frame elements forming two halves of the frame structure and capable of being attached to each other by form-fitting and press-fitting via first and second fastening elements, such as hooks and complementary holes.

[0031] Together with the optional housing, the framework forms the operating element of the ear catheter and is provided at its proximal end.

[0032] Internally, the frame element forms a tubular receptacle for the proximal end of the catheter tube, and the frame element is provided with access points at its proximal end for both the administration lumen and the inflation lumen of the catheter tube.

[0033] A one-way valve, preferably a duckbill valve, is provided at the proximal access point to prevent backflow of medication from the administration lumen or inflation fluid from the dilation lumen. To allow for connection of additional instruments to the access point, first and second connection elements are also provided at the access point, which preferably allow connection via a standard Luer lock.

[0034] Along the receptacle for the catheter tube, there are preferably three compartment boundaries, two adjacent compartment boundaries of which divide a portion of the receptacle into one of two compartments each.

[0035] The first compartment together with the extension lumen of the catheter tube forms a fluid connection unit, which is connected via a first connection to a pressure limiting device or a first umbrella valve. To evacuate the extension lumen, an optional adapter element with an optional hollow tubular tip is provided, which allows the proximal one-way valve to be opened.

[0036] A first notch is provided in the frame for a pressure limiting device or first umbrella valve. When the pressure in the expansion lumen or the combination of the expansion lumen and the first compartment exceeds a predetermined pressure, the first umbrella valve opens, allowing inflation fluid to flow out of the valve, thereby indicating to the user that the maximum allowable pressure has been reached.

[0037] The second compartment, together with the pressure relief lumen of the catheter tube, forms a fluid-connected unit that is connected to a sealing element or a second umbrella valve via a second connection. A second notch is provided in the frame for the sealing element or second umbrella valve. When the pressure in the pressure relief lumen or the combination of the pressure relief lumen and the second compartment exceeds a predetermined pressure, the second umbrella valve opens. The escape of air or, in some cases, medication from this valve indicates to the user that an excess of medication may have been administered.

[0038] Thus, the frame structure including the first and second frame elements comprises a receptacle for the catheter tube, the one-way valve, the pressure limiting device and the sealing element.

[0039] The preferred structure using a frame structure has a significant advantage: the formation of two independent compartments, each containing the key components for pressure release management, such as a pressure release lumen, a one-way valve, and a sealing valve, and the key components for expansion management, such as an expansion lumen, a one-way valve, and an overpressure valve, is a very smart solution for the effective connection of these components.

[0040] The framework connects the three-lumen catheter tubes to their respective access points and securely closes them, simultaneously functioning as a steering aid and allowing the ear catheter to be used safely.

[0041] The frame structure may be further protected by an additional optional similar double shell housing, which provides more comfortable handling and protects the frame structure.

[0042] The ear catheter of the present invention is particularly suitable for administering antibiotic solutions to the middle ear region, which is useful for treating chronic bacterial infections. It may also be useful to administer standard treatment for hearing loss using corticosteroids through such an ear catheter. Standard treatment requires the administration of such corticosteroids over a long period of time, usually about two weeks, with daily re-administration required as the medication drains into the nasopharynx. The treatment period is typically 14 days. The ear catheter of the present invention allows for much more intensive and shorter treatment because the medication is constantly present. Therefore, the treatment period is significantly shortened, sometimes to just a few days. It is particularly suitable for maintaining medication in the middle ear for longer periods, especially for several days.

[0043] The ear catheter remains in the middle ear during treatment, retaining the administered medication in this area without spilling into the nasopharynx. Therefore, patients are ambulatory, long-term hospital stays are unnecessary, and regular medical supervision is sufficient. Otomicroscopy can be used for supervision.

[0044] 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]

[0045] [Figure 1] FIG. 1 is an exploded first perspective view of the proximal portion of a preferred embodiment of an ear catheter; [Figure 2] FIG. 2 is an exploded second perspective view of the proximal portion of a preferred embodiment of an ear catheter. [Figure 3] FIG. 1 shows the interior of the first frame element [Figure 4] FIG. 1 shows the exterior of the first frame element [Figure 5] View showing the interior of the second frame element [Figure 6] View showing the exterior of the second frame element [Figure 7] 1 is a perspective view of the interior of the first frame element; [Figure 8] A perspective view of the interior of the second frame element [Figure 9] FIG. 1 shows the distal portion of a preferred embodiment of an ear catheter. [Figure 10] FIG. 1 shows the distal end of the catheter tube of a preferred embodiment of an ear catheter. [Figure 11] FIG. 1 shows the proximal end of the catheter tube of a preferred embodiment of an ear catheter. [Figure 12A] 1 is a cross-sectional view of an alternative embodiment of a catheter tube; [Figure 12B] 1 is a cross-sectional view of an alternative embodiment of a catheter tube; [Figure 12C] 1 is a cross-sectional view of an alternative embodiment of a catheter tube; DETAILED DESCRIPTION OF THE INVENTION

[0046] Figure 1 shows a first perspective exploded view of the proximal portion 1p of a preferred embodiment of an ear catheter. The distal portion 1d of the ear catheter is not shown, as will be shown below in Figure 9. The proximal portion 1p of the ear catheter comprises a catheter tube 2 embedded in a frame structure comprising a first frame element 3 and a second frame element 4. The frame elements 3, 4 may optionally be surrounded by a first cover element 5 and a second cover element 6.

[0047] The frame elements 3, 4 are provided with access points 7, 8 to both the administration lumen and the inflation lumen of the catheter tube 2. One-way valves 11, 12, preferably duckbill valves, are provided at the proximal access points 7, 8 to prevent backflow of medication from the administration lumen or inflation fluid from the inflation lumen. First and second connection elements 9, 10 are also provided at the access points 7, 8 to allow connection of further instruments to the access points 7, 8, preferably via standard Luer locks.

[0048] To limit the pressure within the balloon (not shown; see FIG. 9), an overpressure limiting device 13, preferably in the form of a first umbrella valve and fluid-permeable connected to the inflation lumen, is provided between the proximally located one-way valve 12 and the distally located balloon. To equalize the overpressure created in the ear by drug administration, a pressure relief lumen is provided, which is fluid-permeable connected to a sealing element 14, preferably in the form of a second umbrella valve.

[0049] In this preferred embodiment shown, frame elements 3, 4 are provided to house all valves 11, 12, 13, 14, the catheter tube, and all necessary fluid permeable connections between the catheter tube 2 and the valves 11, 12, 13, 14. An optional adapter element 16, optionally with a hollow tip, is provided to vent the extension lumen, allowing the proximal one-way valve 12 to be opened.

[0050] Figure 2 shows an alternative exploded perspective view of the proximal portion 1p of a preferred embodiment of an ear catheter. The distal portion 1d of the ear catheter is not shown, as will be shown below in Figure 9. The proximal portion 1p of the ear catheter comprises a catheter tube 2 embedded in a frame structure comprising a first frame element 3 and a second frame element 4. The frame elements 3, 4 may optionally be surrounded by a first cover element 5 and a second cover element 6.

[0051] The frame elements 3, 4 are provided with access points 7, 8 to both the administration lumen and the inflation lumen of the catheter tube 2. One-way valves 11, 12, preferably duckbill valves, are provided at the proximal access points 7, 8 to prevent backflow of medication from the administration lumen or inflation fluid from the inflation lumen. First and second connection elements 9, 10 are also provided at the access points 7, 8 to allow connection of further instruments to the access points 7, 8, preferably via standard Luer locks.

[0052] To limit the pressure within the balloon (not shown; see FIG. 9), an overpressure limiting device 13, preferably in the form of a first umbrella valve and fluid-permeable connected to the inflation lumen, is provided between the proximally located one-way valve 12 and the distally located balloon. To equalize the overpressure created in the ear by drug administration, a pressure relief lumen is provided, which is fluid-permeable connected to a sealing element 14, preferably in the form of a second umbrella valve.

[0053] In this preferred embodiment shown, frame elements 3, 4 are provided to house all valves 11, 12, 13, 14, the catheter tube, and all necessary fluid permeable connections between the catheter tube 2 and the valves 11, 12, 13, 14. An optional adapter element 16, optionally with a hollow tip, is provided to vent the extension lumen, allowing the proximal one-way valve 12 to be opened.

[0054] FIG. 3 shows the interior of the first frame element 3, including the proximal access points to the administration lumen 7 and the extension lumen 8. The first frame element 3 further comprises a receptacle 202 for a catheter tube. Three compartment boundaries I, II, and III are located along the receptacle 202, dividing a portion of the receptacle 202 into two compartments A and B. In this case, compartment boundaries I and II form compartment A, and compartment boundaries II and III form compartment B. Together with the extension lumen of the catheter tube, compartment A forms a fluid-connected unit, which is connected to a pressure limiting device or a first umbrella valve via a first connection 8a. A first notch 13a is provided in the frame element 3 for the pressure limiting device or the first umbrella valve. When the pressure in the extension lumen or the combination of the extension lumen and compartment A exceeds a predetermined pressure, the first umbrella valve opens. The extension pressure is preferably limited to a low overpressure by the first umbrella valve.

[0055] Together with the pressure relief lumen of the catheter tube, compartment B forms a fluidly connected unit, which is connected via a second connection 15 to a sealing element or a second umbrella valve, and a second cutout 14a is provided in the frame element 3 for the sealing element or second umbrella valve. When the pressure in the pressure relief lumen or in the combination of the pressure relief lumen and compartment B exceeds a predetermined pressure, the second umbrella valve opens. Preferably, the opening pressure of the second umbrella valve is set to substantially 0 bar, and the second umbrella valve functions as a sealing element.

[0056] FIG. 4 shows the exterior of the first frame element 3, including proximal access points to the administration lumen 7 and the extension lumen 8. The first frame element 3 further comprises a receptacle 202 for a catheter tube. Three access points to compartment boundaries I, II, and III are located along the receptacle 202, dividing a portion of the receptacle 202 into two compartments A and B. In this case, compartment boundaries I and II form compartment A, and compartment boundaries II and III form compartment B. Together with the extension lumen of the catheter tube, compartment A forms a fluid-connected unit, which is connected to a pressure limiting device or first umbrella valve via a first connection 8a. A first notch 13a is provided in the frame element 3 for the pressure limiting device or first umbrella valve. When the pressure in the extension lumen or the combination of the extension lumen and compartment A exceeds a predetermined pressure, the first umbrella valve opens. The extension pressure is preferably limited to a low overpressure by the first umbrella valve.

[0057] Together with the pressure relief lumen of the catheter tube, compartment B forms a fluidly connected unit.

[0058] FIG. 5 shows the interior of the second frame element 4, which includes proximal access points to the administration lumen 7 and the extension lumen 8. The second frame element 4 further includes a receptacle 202 for a catheter tube. Three compartment boundaries I, II, and III are located along the receptacle 202, dividing a portion of the receptacle 202 into two compartments A and B. In this case, compartment boundaries I and II form compartment A, and compartment boundaries II and III form compartment B. Together with the extension lumen of the catheter tube, compartment A forms a fluid-connected unit, which is connected to a pressure limiting device or a first umbrella valve via a first connection 8a. A first notch 13a is provided in the frame element 4 for the pressure limiting device or the first umbrella valve. When the pressure in the extension lumen or the combination of the extension lumen and compartment A exceeds a predetermined pressure, the first umbrella valve opens. The extension pressure is preferably limited to a low overpressure by the first umbrella valve.

[0059] Together with the pressure relief lumen of the catheter tube, compartment B forms a fluidly connected unit, which is connected via a second connection 15 to a sealing element or a second umbrella valve, and a second cutout 14a is provided in the frame element 4 for the sealing element or second umbrella valve. When the pressure in the pressure relief lumen or in the combination of the pressure relief lumen and compartment B exceeds a predetermined pressure, the second umbrella valve opens. Preferably, the opening pressure of the second umbrella valve is set to substantially 0 bar, and the second umbrella valve functions as a sealing element.

[0060] FIG. 6 shows the exterior of the second frame element 4, including proximal access points to the administration lumen 7 and the extension lumen 8. The second frame element 4 further comprises a receptacle 202 for a catheter tube. Three access points to compartment boundaries I, II, and III are located along the receptacle 202, dividing a portion of the receptacle 202 into two compartments A and B. In this case, compartment boundaries I and II form compartment A, and compartment boundaries II and III form compartment B. Together with the extension lumen of the catheter tube, compartment A forms a fluid-connected unit, which is connected to a pressure limiting device or a first umbrella valve via a first connection. A first notch 13a is provided in the frame element 4 for the pressure limiting device or the first umbrella valve. When the pressure in the extension lumen or the combination of the extension lumen and compartment A exceeds a predetermined pressure, the first umbrella valve opens. The extension pressure is preferably limited to a low overpressure by the first umbrella valve.

[0061] Together with the pressure relief lumen of the catheter tube, section B forms a fluidly connected unit and is connected to a sealing element or a second umbrella valve, and a second cutout 14a is provided for the sealing element or the second umbrella valve.

[0062] FIG. 7 is a perspective view of the interior of the first frame element 3, including the proximal access points to the administration lumen 7 and the extension lumen 8. The first frame element 3 further comprises a receptacle 202 for a catheter tube. Three compartment boundaries I, II, and III are located along the receptacle 202, dividing a portion of the receptacle 202 into two compartments A and B. In this case, compartment boundaries I and II form compartment A, and compartment boundaries II and III form compartment B. Together with the extension lumen of the catheter tube, compartment A forms a fluid-connected unit, which is connected to a pressure limiting device or a first umbrella valve via a first connection 8a. A first cutout 13a is provided in the frame element 3 for the pressure limiting device or the first umbrella valve. When the pressure in the extension lumen or the combination of the extension lumen and compartment A exceeds a predetermined pressure, the first umbrella valve opens. The extension pressure is preferably limited to a low overpressure by the first umbrella valve.

[0063] Together with the pressure relief lumen of the catheter tube, compartment B forms a fluidly connected unit, which is connected via a second connection 15 to a sealing element or a second umbrella valve, and a second cutout 14a is provided in the frame element 3 for the sealing element or second umbrella valve. When the pressure in the pressure relief lumen or in the combination of the pressure relief lumen and compartment B exceeds a predetermined pressure, the second umbrella valve opens. Preferably, the opening pressure of the second umbrella valve is set to substantially 0 bar, and the second umbrella valve functions as a sealing element.

[0064] The first frame element 3 further comprises at least one first fastening element 18, preferably in the form of a hook element 18a, and at least one second fastening element 19, preferably in the form of a circular element 19a, for fastening the first frame element 3 to corresponding complementary fastening elements of the second frame element 4.

[0065] FIG. 8 is a perspective view of the interior of the second frame element 4, which includes proximal access points to the administration lumen 7 and the extension lumen 8. The second frame element 4 further includes a receptacle 202 for a catheter tube. Three compartment boundaries I, II, and III are located along the receptacle 202, dividing a portion of the receptacle 202 into two compartments A and B. In this case, compartment boundaries I and II form compartment A, and compartment boundaries II and III form compartment B. Together with the extension lumen of the catheter tube, compartment A forms a fluid-connected unit, which is connected to a pressure limiting device or a first umbrella valve via a first connection 8a. A first notch 13a is provided in the frame element 4 for the pressure limiting device or the first umbrella valve. When the pressure in the extension lumen or the combination of the extension lumen and compartment A exceeds a predetermined pressure, the first umbrella valve opens. The extension pressure is preferably limited to a low overpressure by the first umbrella valve.

[0066] Together with the pressure relief lumen of the catheter tube, compartment B forms a fluidly connected unit, which is connected via a second connection 15 to a sealing element or a second umbrella valve, and a second cutout 14a is provided in the frame element 4 for the sealing element or second umbrella valve. When the pressure in the pressure relief lumen or in the combination of the pressure relief lumen and compartment B exceeds a predetermined pressure, the second umbrella valve opens. Preferably, the opening pressure of the second umbrella valve is set to substantially 0 bar, and the second umbrella valve functions as a sealing element.

[0067] 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.

[0068] 9 is a perspective view of the distal end 1d of an ear catheter comprising a catheter tube 2 and a dilatation balloon 17 fixed thereto. The distal tip of the catheter tube 2 shows the exit openings of the central administration lumen 2a and the lateral pressure relief lumen 2c. The distal tip 20 of the catheter tube 2 is preferably designed to be atraumatic.

[0069] 10 is a perspective view of the distal end of the catheter tube 2 without a balloon. The distal tip of the catheter tube 2 shows the outlet openings of the central administration lumen 2a and the lateral pressure relief lumen 2c. More proximally, the opening 2b1 of the lateral extension lumen is provided, which connects the extension lumen to a balloon for expansion. The distal tip 20 of the catheter tube 2 is preferably designed to be atraumatic.

[0070] 11 is a perspective view of the proximal end of the catheter tube 2. The proximal end of the catheter tube 2 shows the openings of the central administration lumen 2a, the lateral extension lumen 2b, and the lateral pressure relief lumen 2c. More distally, an opening 2b2 of the extension lumen 2b is provided, which connects the extension lumen 2b to a pressure limiting device or first umbrella valve.

[0071] Figure 12 shows three perspective views of the proximal end of the catheter tube 2 in alternative embodiments A-C for ear catheters, in which the administration lumen 2a and the pressure release lumen 2c are at the proximal end of the balloon rather than the distal end. Advantageously, therefore, none of the lumens 2a, 2b, 2c are centrally located, as shown, for example, in Figures 9-11.

[0072] At the proximal end of the catheter tube 2, the openings of the administration lumen 2a, the inflation lumen 2b and the pressure relief lumen 2c are shown, the lumens being able to be finally arranged according to the respective requirements of the catheter construction. [Explanation of symbols]

[0073] 1 ear catheter (1p: proximal part; 1d: distal part) 2 Catheter tube (2a: Administration lumen; 2b: Expansion lumen; 2b1: Distal opening; 2b2: Proximal opening; 2c: Pressure release lumen) 202 Receptacle for the catheter tube 3 First frame element / First frame 4 Second frame element / Second frame 5 First cover element 6 Second cover element 7 Access point for the administration lumen 8 Access point for the expansion lumen (8a: First connection part) 9 First connection element (Luer lock) 10 Second connection element (Luer lock) 11 First Duckbill valve 12 Second Duckbill valve 13 First Umbrella valve (Pressure limiting device; 13a: First notch) 14 Second Umbrella valve (Pressure limiting device; 14a: Second notch) 15 Second connection part 16 Adapter element 17 Balloon 18 First fixing element (18a: Hook element; 18b: First hole element) 19 Second fixing element (19a: Circular element; 19b: Second hole element) 20 Non-traumatic tip A First compartment (Expansion lumen) B Second compartment (Pressure release lumen) I First compartment boundary II Second compartment boundary III Third compartment boundary

Claims

1. An ear catheter for insertion into the Eustachian canal, comprising a catheter tube (2) having at least three lumens: a first lumen in the form of an administration lumen (2a) for administering a drug, a second lumen in the form of an expansion lumen (2b) for expanding a distally provided expandable balloon (17), and a third lumen in the form of a pressure release lumen (2c) for releasing pressure in the middle ear region; one-way valves (11, 12) are provided in each case to prevent the drug from flowing back out of the administration lumen (2a) and to prevent the inflation fluid from flowing back out of the inflation lumen (2b), and a pressure limiting device (13) is provided to limit the pressure in the balloon; Ear catheter.

2. 2. An ear catheter according to claim 1, characterized in that the administration lumen (2a) and the pressure release lumen (2c) each comprise an opening at the distal end of the balloon (17).

3. 2. An ear catheter according to claim 1, characterized in that the administration lumen (2a) and the pressure release lumen (2c) each terminate in an opening at the proximal end of the balloon (17).

4. Ear catheter according to any one of claims 1 to 3, characterized in that the pressure relief lumen (2c) is provided with a sealing element (14).

5. 5. An ear catheter according to claim 4, characterized in that the sealing element (14) is provided in the form of an umbrella valve.

6. An ear catheter according to any one of claims 1 to 5, characterized in that the pressure limiting device (13) is provided in the form of an umbrella valve.

7. An ear catheter according to any one of claims 1 to 6, characterized in that the one-way valves (11, 12) are provided in the form of duckbill valves.

8. 8. The ear catheter according to claim 1, wherein the ear catheter comprises a frame structure comprising first and second frame elements (3, 4), in which receptacles (7, 13, 13a, 14a, 202) are provided for the catheter tube (2), the one-way valve (11, 12), the pressure limiting device (13) and the sealing element (14).

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

10. 10. An 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), i.e. compartment (A) is delimited by two compartment boundaries (I, II) and compartment (B) is delimited by two compartment boundaries (II, III).

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