OHRKATHETER

Description

[0001] The invention relates to an ear catheter for non-invasive insertion into the Eustachian tube, which allows drug treatment to be carried out in the middle ear area over a longer period of time.

[0002] Numerous diseases of the middle and inner ear are known to require medication. 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. However, administering liquid medications into the Eustachian tube or middle ear is generally not effective in the long term, as the medication tends to pass through the Eustachian tube into the nasopharynx.

[0003] A number of infections, inflammations, and even the treatment of sudden hearing loss or Ménière's disease require long-term treatment that can last for days or a few weeks. In these cases, medication, such as a corticosteroid, is usually administered continuously. This treatment is time-consuming and requires regular and ongoing medical monitoring and care.

[0004] For this reason, it would be desirable to have a device that allows medication to be administered into the middle ear and stored there for an extended period. Such administration should ideally be non-invasive, i.e., without damaging the eardrum. In this case, the only viable option is the natural route via the nasopharynx and the Eustachian tube.

[0005] This task is accomplished using an ear catheter of the type mentioned above, which has a catheter tube, an expandable balloon for closing the Eustachian tube, and an injection channel for introducing medication into the middle ear area.

[0006] Publication US 2006 / 0106361 discloses a non-invasive ear catheter for insertion into the Eustachian tube, comprising a catheter tube, an expandable balloon for occlusion of the Eustachian tube, and an injection channel for the introduction of a drug into the middle ear region.

[0007] An ear catheter according to the present invention is defined in claim 1.

[0008] Such an ear catheter can be inserted non-invasively through the nose and nasopharynx into the Eustachian tube and positioned so that the balloon, after expansion, seals the Eustachian tube. This seal interrupts the connection between the middle ear region distal to the balloon and the nasopharynx. In this context, distal refers to the part of the ear catheter pointing towards the ear and middle ear, while proximal refers to the part pointing away from the ear and middle ear.

[0009] The ear catheter according to the invention is a balloon catheter, which is essentially constructed like a balloon catheter for vascular dilation, but instead of dilating the Eustachian tube, it serves to close it. In this respect, the balloon of the ear catheter is pressurized with only minimal overpressure, such that a cuff forms which closes the Eustachian tube (low-pressure cuff). A single balloon is sufficient for this purpose. The tube of the ear catheter has a length of approximately 15 cm, meaning that this length is sufficient to insert the catheter through one nostril and the nasopharynx into the Eustachian tube, with the proximal end remaining in the patient's cheek area.

[0010] The injection channel runs essentially inside the ear catheter, except for its proximal end, which protrudes laterally. The ear catheter and injection channel are equipped with ports for standard syringes, allowing the catheter to be filled with pressurized fluid and medication solution to be introduced into the inner ear. These ports conveniently use the standard medical Luer-lock system, to which various syringes can be attached with appropriate devices.

[0011] The balloon, catheter, and injection channel can be made from materials commonly used in balloon catheter techniques. These are medically approved plastics such as PVC, polyethylene, polypropylene, and similar materials. The materials should be sufficiently elastic to allow insertion into the Eustachian tube.

[0012] It is advantageous to equip the catheter with a handling aid for guidance. Furthermore, it is advantageous to provide the catheter with a curved distal end, which facilitates the guidance and positioning of the balloon and catheter tip into and within the Eustachian tube. Such a curved end is referred to as a "pig-tail" on catheters and guidewires and is widely used.

[0013] It is understood that the ear catheter has a closure device that retains the applied pressurized medium after inflation and ensures the expanded state. Similarly, the injection channel has a closure at either its distal or proximal end to prevent the injected medication from flowing out through the channel. It is also possible to pinch off the injection channel, which may consist of a soft plastic tube, using the inflated balloon that seals the Eustachian tube.

[0014] The ear catheter according to the invention is inserted non-invasively through the nose and nasopharynx into the Eustachian tube. The insertion can be monitored using an otoscope. Once the expandable balloon has reached the portion of the Eustachian tube to be occluded, it is pressurized with a fluid and expanded in a known manner. It is advantageous to design the balloon as a low-pressure cuff and to provide a pressure limiter, which preferably limits the pressure to a maximum of 1 bar (gauge pressure). A fluid, preferably physiological saline solution, is used to expand the balloon. For the introduction of the saline solution, the proximal connection of the ear catheter is equipped with a conventional Luer lock, to which a syringe for the saline solution can be attached. The catheter tube is equipped with a one-way valve to ensure that the balloon retains the pressure.

[0015] The injection channel, usually an injection tube, leads through the catheter tube and the balloon into the middle ear. At its proximal end, it also has a Luer-lock connector for a syringe through which the medication can be injected into the middle ear. At the distal end is an outlet, which may be designed to be atraumatic and may be equipped with a one-way valve. With a one-way valve, the outlet opens under the pressure of the injected solution. However, if the tube is made of a soft, elastic material, the pressure of the balloon may also be sufficient to close it. In this case, the injection tube is "pinched" under the pressure of the balloon and only opens under the pressure of the injection fluid when it is introduced with the syringe. Alternatively, a one-way valve can also be positioned proximally instead of distally.

[0016] The ear catheter according to the invention is particularly suitable for introducing antibiotic solutions into the middle ear, which is useful in cases of persistent bacterial infections. The standard treatment for sudden hearing loss, which involves the use of 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 a much more intensive and shorter treatment because it ensures the continuous presence of the medication. This significantly reduces the treatment duration, potentially to just a few days. It is particularly suitable for retaining the medication in the middle ear for extended periods, including several days.

[0017] Furthermore, anti-inflammatory medications can also be introduced via the ear catheter.

[0018] The ear catheter is inserted through one nostril and, after pressurization and infusion of the medication, secured to the cheek with a suitable adhesive bandage. It remains in the Eustachian tube throughout the treatment. The patient remains mobile, a prolonged hospital stay is not required, and regular medical monitoring is sufficient. Otomicroscopy can be used for monitoring.

[0019] After treatment, the ear catheter can be easily removed once the pressure has been relieved.

[0020] The ear catheter also allows for the treatment of inner ear diseases, as the medications can usually pass through the membrane of the round window into the inner ear. This is a diffusion process.

[0021] The invention is explained in more detail by the accompanying illustration.

[0022] The ear catheter 1 according to the invention Figure 1 The device consists of a catheter tube 2 that terminates distally in an expandable balloon 3 (cuff). Proximally, there is a Luer-lock connector 4 for a conventional syringe, which can be used to introduce physiological saline solution to inflate the balloon 3. An intermediate pressure gauge (not shown) monitors the pressure and limits it to 1 bar.

[0023] An injection tube 5, also with a Luer-lock connector 6, runs through the center of the catheter, allowing medication solution to be injected using a syringe. The injection channel 5 terminates in an atraumatic outlet or tip 7, which opens under the pressure of the injection fluid and closes automatically after the injection is complete.

[0024] The ear catheter 1 has a total length of approximately 15 cm with a diameter of the catheter tube 2 of 3 mm and a diameter of the injection tube of approximately 1 mm.

[0025] A sleeve 8, which fits snugly onto the catheter, serves as a control and handling aid. The sleeve is preferably made of plastic and expediently slotted to allow it to be attached or removed.

[0026] In the treatment of sudden hearing loss, after catheterization, a 2 ml syringe of cortisone solution is used to inject the solution into the middle ear and leave it there for the required time. The filling of the middle ear is monitored using an otoscope. The procedure is preferably performed under local anesthesia, but general anesthesia may be advisable in certain cases. After administration of the medication, the proximal end of the catheter is covered with an adhesive bandage. The pressure is released from the injection channel. The catheter balloon remains in place in the Eustachian tube, preventing the injected solution from leaking out. Once the treatment is complete, the pressure is released from the balloon and the catheter is removed.

Claims

1. Non-invasive ear catheter for introduction into the eustachian tube with a catheter tube (2), a balloon (3) expandable by a pressure medium for closing the eustachian tube, and an injection channel (5) for introducing a medication into the middle ear region, wherein the injection channel (5) comprises a pressure-dependent one-way valve, characterized in that the ear catheter has a closure device which retains the applied pressure medium in the balloon (3) after filling and ensures the expanded state of the balloon, and is suitable for retaining the medication in the middle ear for several days.

2. Ear catheter according to claim 1, characterized in that the injection channel (5) extends inside the catheter.

3. Ear catheter according to claim 1 or 2, characterized in that the expandable balloon (3) is designed as a low-pressure cuff and, when expanded, forms a cuff that closes the Eustachian tube.

4. Ear catheter according to any one of claims 1 to 3, characterized by a pressure limiter for limiting the pressure of the balloon to a maximum of 1 bar.

5. Ear catheter according to any one of the preceding claims, characterized in that the injection channel (5) is provided with a Luer lock connection (6) for a syringe with injection material.

6. Ear catheter according to any one of the preceding claims, characterized in that the catheter tube (2) is provided with a Luer lock connection (4) for a liquid medium for the expansion of the balloon (3).

7. Ear catheter according to claim 6, characterized in that the pressure medium for expanding the balloon (3) is a physiological NaCl solution.

8. Ear catheter according to any one of the preceding claims, characterized in that the injection channel (5) ends distally from the balloon (3).

9. Ear catheter according to any one of the preceding claims, characterized in that the injection channel (5) is provided with an outlet opening (6) that is of atraumatic design.

10. Ear catheter according to claim 9, characterized in that the outlet opening (6) is of self-closing design and serves as pressure sensitive one-way valve.

11. Ear catheter according to any one of the preceding claims, characterized by a handling aid (8).

12. Ear catheter according to claim 11, characterized in that the handling aid (8) is a plastic sleeve mounted friction-fitting on the catheter tube.