Ear catheter device

Abstract

The invention relates to 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, and a sealing element (14) surrounding the catheter at the distal end, for sealing the Eustachian tube, characterized in that the sealing element is a plug (14) which is supported on the distal end of the insertion aid (10) and fixedly connected to the catheter (12) and which is made of elastomeric material.

Description

[0001] EAR CATHETER DEVICE

[0002] 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 the distal end for closing the Eustachian tube, and a non-return valve associated with the catheter.

[0003] Auricular catheter devices of this type are used to administer a medication into the patient's inner ear and then retain it there for an extended period of time so that it can take effect. In known auricular catheter devices, the insertion aid is withdrawn after the medication has been administered, while the catheter remains in the ear. The non-return valve and the closure element prevent the medication from flowing out of the middle ear through the catheter or through the annular gap between the catheter and the Eustachian tube. DE 10 2021 105 036 A1 describes an auricular catheter device of the above-mentioned type, in which the non-return valve is a one-way valve arranged in a relatively bulky connector housing at the proximal end of the catheter.In addition to an injection lumen for administering the medication, the catheter also features a pressure relief lumen through which the middle ear can be vented during medication administration. This pressure relief lumen can also be closed off using a one-way valve located in the connector housing.

[0004] Since the connector housing represents an obstacle when retracting the introducer, the introducer 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 umbrella which, in the collapsed state, can be inserted together with the catheter through the insertion aid and is then expanded with an expansion device.

[0006] DE 10 2018 102 937 A1 discloses a similar ear catheter device in which the closure element is an inflatable balloon. To inflate this balloon, an additional lumen is required in the catheter.

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

[0008] This object is achieved according to the invention in that the closure element is a plug made of elastomeric material supported on the distal end of the insertion aid and firmly connected to the catheter. In the device according to the invention, the unit comprising plug and catheter is inserted into the Eustachian tube with the insertion aid and advanced until the plug is inserted under slight tension in the constriction between the cartilaginous part and the bony part of the Eustachian tube and is held there in position by a force fit. The annular gap between the catheter and the Eustachian tube is then closed by the plug. The medication delivered via the catheter is released through the backflow preventer into the middle ear. The backflow preventer then prevents backflow of the fluid through the injection lumen of the catheter.After the medication has been administered, the introducer can be withdrawn while the plug and catheter remain in the ear. When the catheter is ready to be removed, a pulling force is applied to the catheter, which overcomes the frictional connection between the plug and the Eustachian tube, allowing the plug to be withdrawn.

[0009] Closing the Eustachian tube with the closure element requires neither a mechanical expansion device nor an additional lumen for balloon expansion. Since there is no bulky valve at the proximal end of the introducer, the introducer does not require laborious dissection, and the elimination of the longitudinal suture simplifies fabrication.

[0010] Advantageous embodiments of the invention are specified in the subclaims.

[0011] In an advantageous embodiment, the outer diameter of the catheter is smaller than the inner diameter of the introducer, 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 when a certain excess pressure in the middle ear is reached. Since the plug forming the closure element is made of elastomeric material, this valve can easily be formed in one piece with the plug.

[0012] In another embodiment, the introducer at the distal end forms an actuating element, which opens the valve when the plug reaches its final position in the Eustachian tube. When the introducer is withdrawn after administration of the medication, the valve is automatically closed again by the retraction movement. This solution has the advantage that the valve does not need to be a pressure relief valve, thus avoiding difficulties in setting a suitable opening pressure for this valve.

[0013] The check valve can be integrated into the catheter at any point and can optionally be formed in one piece with the catheter.

[0014] In another embodiment, the backflow preventer is integrated into the plug. In this case, backflow of fluid through the catheter's injection lumen is prevented at the catheter's entrance into the inner ear. This allows for economical use of the medication, as no medication fluid remains in the catheter's injection lumen. The backflow preventer can be formed in one piece with the plug and, for example, take the form of a duckbill valve.

[0015] 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 fluid can then be easily delivered using an injection needle, eliminating the need for a bulky connector housing.

[0016] The following examples are explained in more detail with reference to the drawings. They show:

[0017] Fig. 1 is a half-section through a distal end of an ear catheter device according to an embodiment of the invention;

[0018] Fig. 2 is a front view of the distal end of the ear catheter device;

[0019] Fig. 3 is a partially cutaway complete view of the ear catheter device;

[0020] Fig. 4 is a half-section through a distal end of an ear catheter device according to another embodiment;

[0021] Fig. 5 is a section through a proximal end of the ear catheter device of Fig. 4;

[0022] Figs. 6 and 7 show partial sections through an ear catheter device according to another embodiment in two different positions; Figs. 8 and 9 show views analogous to Figs. 6 and 7 for a modified embodiment;

[0023] Fig. 10 is a section through the proximal end of the ear catheter device according to Figures 6 and 7 or 8 and 9; and

[0024] Fig. H is a section through the distal end of an ear catheter device according to another embodiment.

[0025] Fig. 1 shows a distal end of a tubular introducer 10 which accommodates a catheter 12 and serves to introduce 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 on 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 constriction between the cartilaginous part and the bony part of the Eustachian tube. For this purpose, the plug has a sequence of circumferential ribs 16 and grooves 18 on its peripheral 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 such that they rest against the inner surface of the Eustachian tube under slight pressure and / or bending stress and offer a certain resistance to a mechanical retraction force acting on the catheter 12.

[0026] The catheter 12 has the configuration of a simple tube with a single (central) lumen, which shall be referred to here as the injection lumen 20. This injection lumen 20 continues into a lumen 22 of the plug 14, which extends into a rounded end section 24 of this plug 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, dividing the end section 24 into two valve lips that bear against each other under tension, thus closing the lumen 22.

[0027] Since the end section 24 protrudes freely into the opening of the Eustachian tube into the middle ear, the two valve lips can be spread apart when fluid is delivered 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 delivered through the lumen 22 can be delivered into the middle ear via the duckbill valve. Since the plug 14, with its circumferential ribs 16, seals the inner surface of the Eustachian tube, the plug simultaneously forms a closure element that prevents the administered fluid from flowing back outside the insertion aid 10.

[0028] 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, running parallel to the lumen 22, which is closed off by a valve 32 at the proximal end adjacent to the pressure relief lumen 28. In this example, the valve 32 is formed by a sealing cuff manufactured in one piece with the plug 14. If fluid is released into the middle ear via the non-return valve 26 and the pressure of the air displaced thereby exceeds a certain value, the sealing cuff can elastically deflect, allowing the displaced air to flow out via the pressure relief lumen 28.

[0029] 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.

[0030] When no more fluid is supplied via the non-return valve 26, the valve 32 closes, preventing the fluid from flowing back out via the pressure relief lumen 28. As long as the plug 14 remains in the narrow passage of the Eustachian tube, the supplied medication fluid is retained in the middle ear, allowing the medication dissolved or suspended in the fluid to take effect. The opening pressure of the non-return valve 26 is set so that the duckbill valve remains closed as long as pressure fluctuations in the nose / pharynx, caused, for example, by swallowing movements, do not exceed normal levels. This prevents the fluid retained in the middle ear from being gradually displaced by incoming air.

[0031] In Fig. 2 the plug 14 is shown in a front view.

[0032] Fig. 3 is 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 the distal end so that the plug 14 can be easily inserted into the Eustachian tube from the patient's nasopharynx.

[0033] A proximal end section of the insertion aid 10 is shown in section in Fig. 3, so that the proximal end of the catheter 12 and the injection volume 20 can be seen. The proximal end of the catheter 12 rests on a narrowed end section 34 of the insertion aid 10, which then merges integrally into a centering aid 36 in a handle 38. The centering aid 36 has an opening at the end opposite the insertion aid 10 for receiving the Luer cone 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 in their hand, the user can thus insert an injection needle into the needle channel 40 and then into the end section of the injection volume 20 in order to administer the liquid.

[0034] Since the plug 14 rests loosely on the end of the introducer, the introducer can be withdrawn after the application of the medication, while the plug 14 and the

[0035] Catheter 12 remains in position. Once the drug exposure time has elapsed, the plug can be withdrawn from the Eustachian tube using catheter 12. Figures 4 and 5 show an ear catheter device according to a modified embodiment. The details of the device are designated by the same reference numerals as the corresponding details in Figures 1 to 3, but incremented by 100.

[0036] According to Fig. 4, the ear catheter device comprises an insertion aid 110 that accommodates a catheter 112. A plug 114 rests on the distal end of the insertion aid 110 and, in this example, is manufactured in one piece with the catheter 112, for example, using a 3D printing process. Although the plug 114 has an end section 124 with a reduced diameter and a rounded end, this does not form a non-return valve in this embodiment, so that the lumen 120 of the catheter 112 opens freely into the middle ear. On the circumference of the end section 124, within the thicker part of the plug provided with ribs 116, two diametrically opposed ventilation openings 130 are formed, each of which is connected to a pressure relief lumen 128 by a valve 132. The multiple ventilation channels 130 reduce the risk of the ventilation path becoming blocked by mucus.

[0037] A proximal end of the ear catheter device according to this embodiment is shown in Fig. 5. Here, too, the insertion aid 110 merges integrally into a centering aid 136 in a handle 138. The catheter 112 is narrowed at a point near the proximal end to a gap that forms a backflow preventer 126. The walls of the catheter are deformed at this point so that, when sufficient pressure in the injection lumen is present, they can elastically yield, allowing the medication fluid to enter the distal part of the catheter. Optionally, an injection needle used to administer the medication can also be inserted far enough into the catheter to mechanically open the backflow preventer 126 during the injection. Two further variants of the valve that controls access to the pressure relief lumen, as well as another variant that does not require such a valve, are described below.Reference numerals which differ from the reference numerals in Figures 1 to 5 by a full hundred denote the same details as in Figures 1 to 5. These details will not be described again.

[0038] Fig. 6 shows only the part of the plug 214 that forms the closure element. In this example, the plug is formed in one piece with the catheter 212, which, together with the insertion aid 210, defines the pressure relief lumen 228. The plug again has two diametrically opposed ventilation openings 230, which, in the state shown in Fig. 6, communicate with the pressure relief lumen 228. At the proximal end of the plug 214, two valves 232 are formed, which serve to block access from the ventilation openings 230 to the pressure relief lumen 228. In Fig. 6, however, the valves 232 are held in an open position by a respective actuating member 240 that protrudes from the distal end of the insertion aid 210. The actuating members 240 extend into the ventilation openings 230 without blocking the opening of the pressure relief lumen 228.

[0039] During the administration of the medication, any excess pressure that may arise in the middle ear can be relieved via the pressure relief lumen 228.

[0040] Fig. 7 shows the state in which, after the administration of the medication, the insertion aid 210 has been retracted a little so that the actuating elements 240 have emerged from the ventilation openings 230. The valves 232, designed as flap valves, then rest against the

[0041] The peripheral surface of the catheter 212 so that they block the proximal ends of the ventilation openings 230 and thus prevent the medication from escaping from the middle ear. At the distal end, the actuating elements 240 each have an insertion bevel so that they spread the flaps of the valves 232 apart when the insertion aid 210 is advanced toward the plug 214. In this way, the valves 232 are automatically opened when the plug 214 is inserted into the Eustachian tube with the aid of the insertion aid 210 and reaches its end position, in which it offers greater resistance to the advancement movement while the insertion aid 210 is advanced further until it reaches the stop positions shown in Fig.

[0042] 6 reached.

[0043] The front end of the catheter 212 or the end portion of the plug 214 is not shown in Figures 6 and 7. This end can optionally form a duckbill valve, as in Figure 1, or form a lumen extending to the distal end, as in Figure 4. In the latter case, the check valve can be integrated into the catheter, similar to Figure 5.

[0044] Figures 8 and 9 are representations analogous to Figures 6 and 7 and show the plug 314 of an ear catheter device according to another embodiment, which differs from the embodiment of Figures 6 and 7 only in the design of the valve 332. While the valve 232 in Figures 6 and 7 is a flap valve that is integrally connected to the plug 214 at its distal end, the valve 332 in Figures 8 and 9 is a flap valve that is integrally connected to the plug 314 at its proximal end. The mode of operation is the same as in Figures 6 and 7. However, there is the advantage here that in Figures 8 and 9 a pressure gradient from the ventilation openings 330 to the pressure relief lumen 328 leads to an increase in the closing force of the valves 332, so that an outflow of the medication fluid from the middle ear can be more reliably prevented.

[0045] In the plug 314 according to Figures 8 and 9, the distal end section can also form a duckbill valve or establish an open connection between the middle ear and the injection lumen. In the latter case, the non-return valve can be integrated into the catheter 312, similar to that in Figure 5. Such a non-return valve 326 at the proximal end of the insertion aid 310 is shown in Figure 10. The insertion aid 310 and the handle 338 are shown in Figure 10 in a state in which the distal end of the insertion aid 310 has not yet quite reached the stop position on the plug. Accordingly, in Figure 10, the proximal end of the catheter 312 is still at a certain distance from the handle 338.An end section of the introducer 310 adjoining the handle 338 is made of transparent material and forms a window 342 so that the user can check the position of the catheter 312 in the introducer to ensure that the introducer is fully advanced into the stop position according to Fig. 6 or 8 and that the valves 232 and 332 are accordingly open before he begins to administer the medication.

[0046] Fig. 11 shows a distal end of an ear catheter device according to another embodiment, comprising an introducer 410 and a catheter 412 integrally formed with the plug 414. The injection lumen 420 extends continuously through the plug 414. The pressure relief lumen 428 is directly connected—without a valve—to the vent opening 430.

[0047] The device shown in Fig. 11 is intended for applications in which the medication is administered in the form of a highly viscous liquid or a gelatinous mass. The cross-section of the vent opening 430 is dimensioned such that the highly viscous or gelatinous mass penetrates the vent opening only a short distance and then forms a plug that prevents the medication from flowing out through the pressure relief lumen 428. The medication can be injected in the same manner as in Fig. 5. During the injection, the displaced air can flow out unhindered through the vent opening 430 and the pressure relief lumen 428 until the medication has filled the cavity in the inner ear and closed the vent opening 430.If the cross-section of the injection lumen 420 is no larger than the cross-section of the vent opening 430, the viscous mass will not penetrate into the injection lumen, so a backflow preventer is unnecessary. In the example shown, the injection lumen has this small cross-section only at its distal end. Further proximally, the cross-section is larger to prevent excessive flow resistance during injection.

Claims

PATENT CLAIMS 1. An ear catheter device for introducing a substance into the middle ear of a patient, comprising a catheter (12; 112; 212; 312; 412), a tubular insertion aid (10; 110; 210; 310; 410) for inserting the catheter (12; 112; 212; 312; 412) from the nose through the Eustachian tube into the middle ear, and a closure element (14; 114; 214; 314; 414) surrounding the catheter at the distal end for closing the Eustachian tube, characterized in that the closure element is a plug (14; 114; 214; 314; 414) made of elastomeric material, supported on the distal end of the insertion aid (10; 110; 210; 310; 410) and firmly connected to the catheter (12; 112; 212; 312; 412).

2. An ear catheter device according to claim 1, comprising a backflow preventer (26; 126; 326) associated with the catheter (12; 112; 212; 312).

3. An ear catheter device according to claim 2, wherein the non-return valve (126; 326) is integrated into the catheter.

4. An ear catheter device according to claim 2 or 3, wherein the non-return valve (126; 326) is formed in one piece with the catheter and is formed by an expandable constriction of the catheter.

5. An ear catheter device according to claim 2, wherein the non-return valve (26) is integrated into the plug (14).

6. An ear catheter device according to claim 5, wherein the non-return valve (26) is a one-way valve formed integrally with the plug (14) which closes the distal end of an injection lumen (20) of the catheter (12).

7. An ear catheter device according to claim 6, wherein the non-return valve (26) is a duckbill valve forming an end portion (24) of the plug (14) which is reduced in diameter and rounded at the end.

8. An ear catheter device according to claim 1, wherein the catheter (412) has an injection lumen (420) which is narrowed in cross-section over a portion of its length.

9. An ear catheter device according to claim 8, wherein the cross-sectionally narrowed portion of the injection lumen (420) is located at the distal end.

10. An ear catheter device according to any one of the preceding claims, wherein a pressure relief lumen (28; 128; 228; 328; 428) is formed between the outer circumference of the catheter (12; 112; 212; 312; 412) and the inner circumference of the insertion aid (10; 110; 210; 310; 410), which can be connected to the space in the middle ear of the patient via at least one ventilation opening (30; 130; 230; 330; 430) in the plug (14; 114; 214; 314).

11. An ear catheter device according to claim 10, wherein the ventilation opening (30; 130) can be closed by a valve (32; 132) which opens at a predetermined overpressure in the middle ear of the patient.

12. An ear catheter device according to claim 11, wherein the valve (32; 132) is formed by a sealing sleeve formed in one piece with the plug (14; 114).

13. An ear catheter device according to claim 10, wherein the vent opening (230; 330) can be closed by a valve (232; 332) which can be elastically moved into the closed position is pre-tensioned and can be opened by means of an actuating member (240; 340) formed on the insertion aid (210; 310).

14. An ear catheter device according to claim 13, wherein the valve (232) is a flap valve resiliently connected to the plug (214) at its distal end.

15. An ear catheter device according to claim 13, wherein the valve (332) is a flap valve resiliently connected to the plug (314) at its proximal end.

16. An ear catheter device according to any one of the preceding claims, wherein the insertion aid (10; 110; 310) merges at the proximal end into a centering aid (36; 136) through which an injection needle can be inserted into the interior of the catheter (12; 112; 312).

17. An ear catheter device according to claim 13, 14 or 15, wherein the insertion aid (310) has a window (342) at the proximal end that provides a view of the proximal end of the catheter (312). 0 18. An ear catheter device according to claim 10, wherein the pressure relief lumen (428) is permanently connected to the ventilation opening (430).

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