Ear catheter device

Abstract

Ear catheter device for introducing a substance into the middle ear of a patient, comprising a catheter (12), a tubular introducer (10) for introducing the catheter (12) from the nose through the Eustachian tube into the middle ear, a closure element (14) surrounding the catheter (12) at its distal end for closing the Eustachian tube, and a non-return valve (26) associated with the catheter (12), characterized in that the closure element is a plug (14) made of elastomeric material supported on the distal end of the introducer (10) and firmly connected to the catheter (12), and that the non-return valve (26) is integrated into the plug (14).

Description

[0001] The invention relates to an ear catheter device for introducing a substance into the middle ear of a patient, comprising a catheter, a tubular insertion aid for inserting the catheter from the nose through the Eustachian tube into the middle ear, a closure element surrounding the catheter at its distal end for closing the Eustachian tube, and a backflow preventer associated with the catheter.

[0002] Ear catheter devices of this type are used to administer medication into the patient's inner ear and then retain it there for an extended period to allow it to take effect. With known ear catheter devices, the introducer is withdrawn after the medication is administered, while the catheter remains in the ear. The anti-reflux valve and the closure element prevent the medication from flowing out of the middle ear through the catheter or through the annular space between the catheter and the Eustachian tube.

[0003] German patent DE 10 2021 105 036 A1 describes an ear catheter device of the type mentioned above, in which the backflow preventer is a one-way valve located in a relatively bulky connection housing at the proximal end of the catheter. In addition to an injection lumen for administering the medication, the catheter also has a pressure relief lumen through which the middle ear can be vented during medication administration. This pressure relief lumen can also be closed off by means of a one-way valve located in the connection housing.

[0004] Since the connector housing presents an obstacle when retracting the insertion aid, the insertion aid has a longitudinal seam along which it can be cut open so that it can be detached from the catheter.

[0005] In the known device, the closure element is formed by an expandable shield which, in its collapsed state, can be inserted through the insertion aid together with the catheter and is then expanded with an expansion device.

[0006] A similar ear catheter device is known from DE 10 2018 102 937 A1, in which the closure element is an inflatable balloon. An additional lumen is then required in the catheter to inflate this balloon.

[0007] The object of the invention is to create an ear catheter device that is easier to manufacture and easier to handle.

[0008] This problem is solved according to the invention by the fact that the closure element is a plug made of elastomeric material which is supported on the distal end of the insertion aid and firmly connected to the catheter, and that the backflow preventer is integrated into the plug.

[0009] In the device according to the invention, the unit consisting of the plug and catheter, along with the introducer, is inserted into the Eustachian tube and advanced until the plug is held in position under slight tension in the narrow passage between the cartilaginous and bony parts of the Eustachian tube. The annular gap between the catheter and the Eustachian tube is then closed by the plug. The non-return valve is integrated into the plug and is thus located at the distal end of the catheter. The medication administered via the catheter is released through the non-return valve into the middle ear, and backflow of the fluid through the catheter's injection lumen is prevented at the catheter's opening into the inner ear. This allows for economical use of the medication, as no medication fluid remains in the catheter's injection lumen.After the medication has been administered, the introducer can be withdrawn, leaving the plug and catheter in the ear. To remove the catheter, a traction force is applied to overcome the friction between the plug and the Eustachian tube, allowing the plug to be withdrawn.

[0010] To close the Eustachian tube using the closure element, neither a mechanical expansion device nor an additional lumen for balloon expansion is required. Since there is no bulky valve at the proximal end of the insertion aid, it does not need to be laboriously cut open, and the elimination of the longitudinal seam simplifies its manufacture.

[0011] Advantageous embodiments of the invention are specified in the dependent claims.

[0012] In an advantageous embodiment, the outer diameter of the catheter is smaller than the inner diameter of the insertion aid, creating an annular gap between these components that can be used as a pressure relief lumen. Backflow of the medication fluid through this pressure relief lumen can be prevented by forming a valve at the opening of this lumen into the inner ear, which only opens at a certain overpressure in the middle ear. Since the plug forming the closure element is made of an elastomeric material, this valve can easily be formed as a single unit with the plug. The non-return valve, which prevents backflow of the fluid through the injection lumen, can also be formed as a single unit with the plug and, for example, have the shape of a duckbill valve.

[0013] A centering piece can be provided at the proximal end of the introducer and catheter to facilitate the insertion of an injection needle into the catheter's injection lumen. The medication can then be easily administered using an injection needle, eliminating the need for a bulky connector housing.

[0014] The following are examples of implementation explained in more detail with reference to the drawings.

[0015] They show: Fig. 1 a half section through a distal end of the ear catheter device according to the invention; Fig. 2 a front view of the distal end of the ear catheter device; and Fig. 3 A partially cutaway complete view of the ear catheter device.

[0016] In Fig. Figure 1 shows the distal end of a tubular introducer 10, which accommodates a catheter 12 and serves to insert the catheter from the nose into the Eustachian tube of a patient in order to administer a fluid, e.g., a medication, into the patient's middle ear. A plug 14 made of elastomeric material rests against the end of the introducer 10. This plug is firmly connected to the end of the catheter 12 and serves to mechanically fix the catheter in the narrow passage between the cartilaginous and bony parts of the Eustachian tube. For this purpose, the plug has a series of circumferential ribs 16 and grooves 18 on its circumferential surface (in this example, only one groove is present).The ribs 16 have a slightly larger outer diameter than the insertion aid 10 and are dimensioned so that they lie against the inner surface of the Eustachian tube under slight compressive and / or bending stress and offer some resistance to a mechanical retraction force acting on the insertion aid 10.

[0017] The catheter 12 has the configuration of a simple tube with a single (central) lumen, which here shall be referred to as the injection lumen 20. This injection lumen 20 continues into a lumen 22 of the stopper 14, which extends into a rounded end section 24 of this stopper and is closed at the end by a non-return valve 26 in the form of a duckbill valve. The non-return valve 26 is formed by a gap extending from the apex of the end section 24 to the tapered end of the lumen 22, which divides the end section 24 into two valve lips that are held under tension against each other and thus seal the lumen 22.

[0018] Since the end section 24 projects freely into the orifice of the Eustachian tube in the middle ear, the two valve lips can be spread apart when fluid is introduced through the injection lumen 20 into the lumen 22 and the pressure gradient between the lumen 22 and the interior of the middle ear exceeds a certain threshold. In this way, the fluid introduced through the lumen 22 can be released into the middle ear via the duckbill valve. Because the plug 14, with its circumferential ribs 16, seals against the inner surface of the Eustachian tube, it simultaneously forms a closure element that prevents the administered fluid from flowing back outside the delivery aid 10.

[0019] The outer diameter of the catheter 12 is smaller than the inner diameter of the introducer 10, so that an annular gap is formed between the catheter and the introducer, which serves as a pressure relief lumen 28. In the end section 24 of the plug 14, a ventilation opening 30 is formed parallel to the lumen 22, which is closed at its proximal end, adjacent to the pressure relief lumen 28, by a valve 32. In this example, the valve 32 is formed by a sealing cuff that is manufactured as a single unit with the plug 14. If fluid is delivered into the middle ear via the non-return valve 26 and the pressure of the displaced air exceeds a certain value, the sealing cuff can deflect elastically, allowing the displaced air to flow out through the pressure relief lumen 28.

[0020] The stiffness of the sealing cuff is adjusted so that the pressure in the middle ear cannot rise to a level that would be harmful or uncomfortable for the patient.

[0021] If no further fluid is supplied via the non-return valve 26, the valve 32 closes, thus preventing the fluid from flowing back out through the pressure relief lumen 28. As long as the plug 14 is in the constriction of the Eustachian tube, the supplied medication fluid is therefore retained in the middle ear, allowing the medication dissolved or suspended in the fluid to take effect.

[0022] The opening pressure of the non-return valve 26 is set so that the duckbill valve remains closed as long as the pressure fluctuations in the nasal / pharyngeal cavity, caused for example by swallowing movements, do not exceed the normal level. This prevents the fluid held in the middle ear from being gradually displaced by incoming air.

[0023] In Fig. Figure 2 shows plug 14 in a front view.

[0024] Fig. Figure 3 shows a complete view of the ear catheter device with the introducer 10 and the plug 14 at the distal end. The introducer 10 is a relatively rigid tube that is bent at its distal end so that the plug 14 can be easily inserted into the Eustachian tube from the patient's nasal / pharyngeal cavity.

[0025] A proximal end section of the insertion aid 10 is in Fig.Figure 3 shows a cross-sectional view, revealing the proximal end of the catheter 12 and the injection lumen 20. The proximal end of the catheter 12 rests against a narrowed end section 34 of the introducer 10, which then seamlessly transitions into a centering aid 36 within a handle 38. The centering aid 36 has an opening at the end opposite the introducer 10 to accommodate the Luer connector of an injection syringe (not shown) and then narrows conically to a needle channel 40, which is aligned with the injection lumen 20 of the catheter 12. While holding the handle 38, the user can thus insert an injection needle into the needle channel 40 and then into the end section of the injection lumen 20 to administer the fluid. Since the plug 14 rests loosely at the end of the insertion aid, the insertion aid can be withdrawn after the application of the medication, while the plug 14 and the catheter 12 remain in position.Once the drug's exposure time has elapsed, the plug can be pulled out of the Eustachian tube using catheter 12. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] DE 10 2021 105 036 A1

[0003] DE 10 2018 102 937 A1

[0006]

Claims

[1] An ear catheter device for introducing a substance into the middle ear of a patient, comprising a catheter (12), a tubular insertion aid (10) for inserting the catheter (12) from the nose through the Eustachian tube into the middle ear, a closure element (14) surrounding the catheter (12) at the distal end for closing the Eustachian tube, and a non-return valve (26) associated with the catheter (12), characterized by that the closure element is a plug (14) made of elastomeric material supported on the distal end of the insertion aid (10) and firmly connected to the catheter (12), and that the non-return valve (26) is integrated into the plug (14). [2] An ear catheter device according to claim 1, wherein the non-return valve (26) is a one-way valve formed integrally with the plug (14) that closes the distal end of an injection lumen (20) of the catheter (12). [3] An ear catheter device according to claim 2, wherein the non-return valve (26) is a duckbill valve forming a reduced diameter and rounded end portion (24) of the plug (14). [4] An ear catheter device according to any one of the preceding claims, wherein an injection lumen (20) formed coaxially in the catheter (12) continues into a lumen (22) in the plug (14) leading to the non-return valve (26). [5] Ear catheter device according to one of the preceding claims, in which a pressure relief lumen (28) is formed between the outer circumference of the catheter (12) and the inner circumference of the insertion aid (10), which can be connected to the space in the middle ear of the patient via a ventilation opening (30) in the plug (14). [6] Ear catheter device according to claim 5, wherein the ventilation opening (30) can be closed by a valve (32) which opens at a predetermined overpressure in the middle ear of the patient. [7] An ear catheter device according to claim 6, wherein the valve (32) is formed by a sealing sleeve formed in one piece with the plug (14). [8] Ear catheter device according to one of the preceding claims, in which the insertion aid (10) at the proximal end merges into a centering aid (36) through which an injection needle can be inserted into the interior of the catheter (20).

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