Ear catheter and insertion aid for catheter

Abstract

This invention provides an insertion aid for use with an ear catheter for insertion into the Eustachian tube. [Solution] The insertion assist means is used to facilitate the insertion of an ear catheter into the middle ear by passing it through the patient's nose. The insertion assist means (101) has a headpiece (102, 102'), an intermediate piece (103, 103'), and an end piece, and is made of a biocompatible polymer. At least one separation line (105) extends through at least the intermediate piece and the end piece, respectively, and is configured to allow the insertion assist means to be opened or separated along the separation line.

Description

Technical Field

[0001] The present invention relates to an ear catheter provided with an occluding means for administering a drug into the eustachian tube, and an insertion assisting means for a catheter, which comprises a head piece, an intermediate piece and an end piece and is made of a biocompatible polymer. The insertion assisting means is particularly used for facilitating the placement of an ear catheter through a patient's nose into the middle ear.

Background Art

[0002] Numerous diseases of the middle ear and inner ear that require local treatment are well known. When local treatment is required, the treatment can be performed via the tympanic membrane on the one hand and via the eustachian tube on the other hand. Treatment of the inner ear can also be performed via the middle ear region. Treatment often uses an ear catheter inserted through the nose, by which the drug is also introduced. However, delivery of the drug, particularly in liquid form, into the eustachian tube or middle ear is often non-sustained, because the drug can flow out through the eustachian tube to the nasopharynx in a short time.

[0003] Many infectious diseases and inflammations, as well as the treatment of hearing loss or Meniere's disease, require relatively long-term treatment that can be prolonged over several days or weeks. Generally, in this case, a new drug, for example a corticosteroid, is continuously supplied. This treatment is time-consuming and requires regular, continuous monitoring and attendance by a physician.

[0004] For this reason, it is desirable to use an ear catheter that allows the drug to be administered into the middle ear and stored and retained there for a longer period of time. It is desirable that such administration be performed as non-invasively as possible, that is, without damaging the tympanic membrane. In this case, only the natural approach via the nasopharynx and the eustachian tube (auditory tube) is considered.

[0005] The corresponding ear catheter described in Patent Document 1 is insertable into the Eustachian tube via the nasopharynx and has an inflatable balloon for occlusion. An injection passage is guided through the balloon, allowing the drug to be administered into the Eustachian tube distal to the balloon, and the balloon prevents the drug from flowing back into the nasopharynx.

[0006] This known ear catheter has several drawbacks. On the one hand, it lacks a pressure compensation mechanism distal to the balloon that can compensate for the excessive pressure generated in the middle ear due to drug administration. Furthermore, this known ear catheter completely lacks a marker that allows the user to accurately position the inserted catheter. Moreover, balloons, such as those proposed as occlusion members, can sometimes produce pressure marks. This can hardly be prevented even with pressure limiting mechanisms for the balloon, which may be provided, or by selecting a balloon with extremely high adaptability, because at least some pressure is required to achieve the occlusion effect of the balloon. Furthermore, the operation of ear catheters with inflatable balloons is relatively complex because an additional instrument is always required to inflate (and deflate) the balloon.

[0007] Inserting an ear catheter through a patient's nose is not easy, especially if the catheter is made of a highly flexible material. In this case, an insertion aid is desirable. However, the use of an insertion aid becomes problematic when the catheter needs to be fixed in the middle ear or Eustachian tube for a longer period of time for treatment. This is because the proximal end is generally equipped with a device for connecting the catheter to another device, such as an infusion bottle or a pressure supply device. In this case, the insertion aid cannot be easily removed proximal to the catheter tube because the connection point for the other device or the other device itself is located there. It is also impossible to remove the insertion device distally, because the catheter is fixed at its distal end to a target structure, such as the Eustachian tube. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] German Patent Application Publication No. 102018102937 [Overview of the project]

[0009] Therefore, the object of the present invention is to provide an ear catheter equipped with an occlusion means that does not have at least some of the aforementioned drawbacks, is easy to operate, and causes little to no irritation to the Eustachian tube, especially when the dwell time is longer.

[0010] Furthermore, an object of the present invention is to provide an insertion assisting means that allows a catheter, such as an ear catheter, to be easily and quickly inserted into the Eustachian tube, for example, through the patient's nose, and that, after the catheter has been placed, can be at least partially removed again without the need to remove the catheter or the device connected to the catheter.

[0011] This problem is solved by the apparatus described in independent claims 1 and 14. Another configuration of the present invention is described in the dependent claims.

[0012] This problem is solved by the ear catheter according to the present invention, which has a catheter tube equipped with an injection lumen for introducing a drug and a pressure-relieving lumen for reducing pressure in the middle ear, as well as an inflatable occlusion member.

[0013] Such ear catheters can be non-invasively inserted into the Eustachian tube through the nose and nasopharynx, and positioned there, so that the occluding member, after inflation, fluid-tightly occludes the Eustachian tube from the nasopharynx. In this case, the occluding member blocks the connection from the middle ear region located distal to the occluding member to the nasopharynx located proximal to the occluding member, thereby effectively preventing the fluid introduced through the injection lumen ending distal to the occluding member from flowing into the nasopharynx.

[0014] In relation to the present invention, "distal side" refers to the portion of the device facing away from the user along the catheter or insertion aid, while "proximal side" refers to the portion facing the user along the catheter or insertion aid. Further details regarding the positional relationship can be seen in the drawings.

[0015] The occluding member may be an inflatable balloon or, in one preferred embodiment, an inflatable shield.

[0016] The injection channel extends consistently from the distal end to the proximal end of the catheter tube and terminates distally downstream of the occlusion member.

[0017] Similarly, the pressure-relieving lumen begins at the proximal end of the catheter tube and ends distally downstream of the occlusion member. The exact position of the distal opening of the pressure-relieving lumen distal to the occlusion member is variable, and the only functionally important point is that the distal outlet opening is also located distal to the occlusion member.

[0018] The catheter tube may contain another lumen, such as a lumen for another injection lumen, or a lumen for housing, for example, a removable support wire for stabilizing the catheter tube while it is in position.

[0019] In addition to these lumens, the catheter tube also has at least one other lumen as an expansion lumen, if an inflatable balloon is provided as an occluding member.

[0020] For catheter tubing, common materials known from catheter technology can be used. These are generally medically approved plastics, such as PVC, polyethylene, and polypropylene. The material should be sufficiently flexible to allow for catheter insertion into the Eustachian tube.

[0021] Similarly, balloons may be provided that are made from common materials, such as those generally used for balloons in medical technology in general.

[0022] The shielding body according to the present invention has a self-expanding support member covered with a membrane, in which case the entire shielding body can reversibly transition from a compressed state to an expanded state. This allows for the rearrangement of the shielding body as needed.

[0023] Self-expandable support members may exist as individual, unconnected support members, for example, as multiple annular or spoke-shaped segments. Preferably, however, the self-expandable support members are at least partially connected to one another and are provided in the form of a frame, for example, as a vascular support for a stent. Accordingly, the self-expandable support members or frame may be provided as tubes cut by a laser cutting method, or in the form of an organized structure.

[0024] Suitable materials for the frame are well-known shape memory materials, as are also known from other self-expanding implants. These include spring steel, nitinol compounds, or polymers. However, the material for the shield frame should preferably be non-absorbent so as not to compromise the stability of the shield.

[0025] The shield of the ear catheter according to the present invention is only used for occlusion, and is not used for keeping a lumen open like other vascular supports, so only a small radial force of the shield is required. On the contrary, high radial force must be avoided. This is because high radial force may cause pressure marks or necrosis in the sensitive ear canal. Known materials enable extremely accurate adjustment of radial force.

[0026] The self-expandable support member or frame is covered by a membrane. The membrane is liquid-impermeable. Corresponding liquid-impermeable biocompatible films, as are also known from other implants provided with membranes, for example stent grafts, are suitable as materials for the membrane. Particularly suitable are various plastic membranes made of, for example, PTFE or ePTFE.

[0027] The membrane must be reliably attached to the frame, which can be done in various ways, for example by adhesion, welding, or via a suitable tightening device. Combinations of these techniques are also conceivable. The bond between the frame and the membrane needs to be reliable, but it is not exposed to loads such as those encountered in, for example, stent grafts. This is because the shield of an ear catheter is not exposed to continuous blood flow, and is only used to retain the administered liquid.

[0028] Preferably, the membrane is liquid-tightly connected at its proximal portion to the distal catheter end, which will be described in detail below with respect to the shield.

[0029] The shield is preferably formed in a conical or funnel shape, and includes a proximal end having a first diameter and a distal end having a second diameter, wherein the second diameter is larger than the first diameter.

[0030] However, a plurality of other shapes of the shield or the shield frame are conceivable, and will be described in more detail below based on detailed drawings.

[0031] The shield is fixed to the distal end of the catheter tube at its proximal end. The first diameter of the shield can be appropriately selected to allow for a suitable connection with the catheter tube, that is, to substantially correspond to the diameter of the catheter tube.

[0032] Preferably, a fixing aid is provided at the proximal end of the shield, for example, in the form of a tubular or tubular attachment, which can be attached inside or around the distal catheter lumen, thus enabling a liquid-tight connection between the shield and the catheter tube. The diameter of the fixing aid may be selected in correspondence with the diameter of the catheter, in which case the outer diameter of the fixing aid corresponds in particular to the inner diameter of the catheter, or vice versa.

[0033] Other types of connections between the shield and the catheter are also possible. Some of these, to name just a few possibilities, include screw fastening, locking joints, shape-coupled joints, adhesive joints, or injection-molded joints.

[0034] In this case, the attachment point of the shield on the catheter tube must not obstruct the inflation or compression of the shield via the inflation device, which is described more precisely. Accordingly, attachment of the shield to the outer surface of the catheter tube should be avoided, or attachment of the shield that creates an edge on the outer surface of the catheter should be avoided.

[0035] Preferably, the shielding member is attached to the catheter tube on the inner surface of the distal end of the catheter tube, or in alignment with the catheter end, i.e., at the distal outlet opening of the catheter tube, so that the outlet openings of the lumen, particularly the injection lumen and the pressure relief lumen, are not closed, allowing for continued administration of fluid and release of excess pressure. The same applies to the inflation lumen if a balloon is provided as the occlusion member.

[0036] In one alternative embodiment of the configuration in which a shielding body is provided as an occlusion member, the lumen may protrude beyond the distal end of the shielding body even at the distal end of the extended portion of the catheter tube. To avoid injury, particularly in this embodiment and in the embodiment with a balloon, a non-traumatic tip is provided at the distal end of the thus extended catheter tube.

[0037] The second diameter of the shield or the reference diameter of the balloon may be selected such that they correspond to at least the diameter of the portion of the eartube that needs to be sealed liquid-tight. Preferably, the second diameter of the shield or the reference diameter of the balloon is selected to be slightly larger than the diameter of the corresponding eartube.

[0038] The structure of the shield, consisting of a frame and a membrane, is designed to allow the expansion device, which will be explained in more detail below, to be retracted proximally from the compressed shield without any problems, and to be advanced distally while covering the expanded shield.

[0039] One possible solution is to form the shield in a funnel shape or a conical / circular shape, that is, a structure that expands from the proximal to the distal end. At the very least, it is desirable that the shield has a correspondingly expanding region at the end that connects to the catheter tube.

[0040] The shape of the shield in a state where it can be freely inflated, that is, without an inflation device or external force such as an eartube, can be determined by the membrane and / or frame. Accordingly, the maximum inflation of the shield is limited at each position by the membrane, frame, or support members.

[0041] Since the shield and the catheter tube are liquid-tightly coupled to each other, there is no risk of the fluid administered through the catheter tube leaking proximally between the catheter tube and the expanded shield.

[0042] The shielding body may be reversibly transitioned from a compressed state to an expanded state by an inflation device. For this purpose, the inflation device is provided in a tubular shape, similar to the catheter tube, and completely surrounds the catheter tube in a shape-coupled manner, in which case a liquid-tight occlusion between the inflation device and the catheter tube is not required. The occlusion of the ear catheter is determined solely by the shielding body.

[0043] The inflation device is positioned to be movable at least axially relative to the catheter tube, thereby allowing the inflation device to move along the catheter tube from proximal to distal or vice versa. Preferably, the inflation device extends from the proximal end of the catheter tube up to the attachment point of the shield on the catheter tube, and can be moved along the catheter tube beyond the distal end of the shield.

[0044] Distal movement of the inflator, that is, when the inflator is moved beyond the shield fixed to the distal end of the catheter tube, will cause compression of the shield. Correspondingly, proximal movement of the inflator, that is, when the inflator moves downward from the shield and the shield can be opened without external force from the inflator, will cause inflation of the shield.

[0045] For better operation, the inflation device has an optional operating member at its proximal end, which allows the inflation device to be moved along the catheter.

[0046] The tubing of the ear catheter should preferably be approximately 15 cm to 30 cm in length. The length should be sufficient to pass the catheter through the nostril and nasopharynx and into the Eustachian tube, in which case the proximal end can remain in the area of ​​the patient's cheek or, in one alternative embodiment, can be fixed behind the corresponding ear of the patient.

[0047] The ear catheter or injection lumen is equipped with a connector for a common syringe at its proximal end, which allows for the filling of the ear catheter with a pressure medium and the introduction of medication into the inner ear. The connector is advantageously a Luer lock system, which is common in medicine, and various syringes can be connected to the Luer lock system via a corresponding device.

[0048] Accordingly, the pressure relief lumen may also be equipped with a connector at the proximal end of the catheter, but it may also end without a special connector. The connector is advantageously a Luer lock system, which is common in medicine, and various syringes can be connected to the Luer lock system via a corresponding device.

[0049] Preferably, the inflation device may be detachably fixed to the proximal end of the catheter tube when the shield is inflated, thereby preventing unintended compression of the shield. Preferably, a detachable connecting means is provided for this purpose between the operating member of the inflation device and the Luer lock system. In this case, a simple locking member provided to fit mutually with the Luer lock system and the operating member is conceivable. Other locking devices are also conceivable, in which case various means are well known to those skilled in the art.

[0050] To prevent unintended inflation due to the inflation device slipping proximal to the nasopharynx while the ear catheter is being positioned through the nose and nasopharynx, a spacer may be provided between the connecting device at the proximal end of the ear catheter and the means for operating the inflation device. The spacer may be provided as a slitted tube, which can be removed and reattached.

[0051] It is self-evident that an ear catheter or injection lumen has a closure device to prevent backflow after the injected drug has been filled. Accordingly, the injection lumen has a closure means, such as a check valve, at its distal or proximal end to prevent the injected drug from flowing out through the lumen. In the case of a check valve, the outlet opening opens accordingly due to the injection pressure and then closes again.

[0052] The pressure-relieving lumen also has a closing mechanism, such as a check valve, at its distal or proximal end to prevent the injected drug from flowing out through the lumen. In the case of a check valve, the outlet opening opens due to the corresponding pressure and then closes again.

[0053] The closing device may be provided as a simple self-closing valve.

[0054] It is advantageous to equip the catheter with maneuvering aids for control during placement. Furthermore, it is advantageous to provide the catheter with a curved distal end, as this curved distal end facilitates the control and placement of the catheter within and into the Eustachian tube. Such a curved end is called a "pigtail" in catheters and guidewires and is widely used.

[0055] The ear catheter according to the present invention is non-invasively passed through the nose and nasopharynx and inserted into the Eustachian tube. Insertion can be monitored by an ear microscope. The inflatable occlusion member, i.e., the shield or balloon, is inflated by activating an inflation device as soon as it reaches the portion of the Eustachian tube to be closed.

[0056] To assist in positioning the catheter or occlusion member, multiple markings may be provided on the distal end of the catheter, but on the proximal side of the occlusion member. These markings, or markers for short, may be provided sequentially and can be identified by the therapist using a microscope during placement. An advantage is the use of multiple markers, which may, for example, mark a first non-critical feeding area with a green marking, a second high-attention area with a yellow marking, and a third critical area with a red marking. In this case, the concepts of "non-critical," "high-attention," and "critical" relate to the progression of the catheter tip's penetration into the inner ear and, consequently, the increasing critical approach to sensitive areas.

[0057] The injection lumen terminates distal to the occlusion member. The injection lumen has a Luer lock connector at its proximal end for a syringe, preferably for administering medication to the middle ear region.

[0058] The ear catheter according to the present invention is particularly suitable for administering antibiotic solutions to the middle ear region, which is significant in cases of difficult-to-treat bacterial infections. Standard treatment for hearing loss using corticosteroids can also be significantly carried out via such an ear catheter. Standard treatment requires the administration of such corticosteroids for a relatively long period, usually about two weeks, in which case the drug must be administered fresh daily as it flows into the nasopharynx. Generally, treatment lasts for 14 days. The ear catheter according to the present invention enables a much more intensive and shorter treatment because it ensures the presence of the drug. This significantly reduces the duration of treatment, in some cases to just a few days. The ear catheter according to the present invention is particularly suitable for retaining the drug in the middle ear for a relatively long period, especially for several days.

[0059] Furthermore, anti-inflammatory drugs can also be introduced via an ear catheter.

[0060] The ear catheter is inserted through one nostril, optionally with an additional insertion aid according to the present invention, and can be secured to the cheek or, alternatively, behind the ear with a suitable adhesive bandage after the shield has expanded and the drug has been administered.

[0061] The ear catheter remains in the Eustachian tube during treatment, thus retaining the administered medication within the area of ​​the tube and preventing reflux into the nasopharynx. Therefore, the patient remains mobile, and relatively long stays at the clinic are unnecessary; regular monitoring by a physician is sufficient. An ear microscope may be used for monitoring.

[0062] After treatment, the occlusion material can be compressed, and then the ear catheter can be removed without any problems.

[0063] Ear catheters can also be used to treat inner ear disorders because they typically allow medication to leak into the inner ear through the membrane of the cochlear window. In this case, it's a diffusion process.

[0064] Some possible indications include intratympanic steroid administration for hearing loss, intratympanic steroid administration for edema (Meniere's disease), intratympanic gentamicin administration for edema, intratympanic contrast agent administration for suspected edema, intratympanic administration for gene therapy (CRISPR / Cas9), or intratympanic topical antibiotic use. Use for other indications is at the discretion of the attending physician.

[0065] Substances that may be administered in this manner include, for example, dexamethasone, methylprednisolone, gentamicin, neomycin, growth factors, BDNF, neurotrophin-3, N-acetylcysteine, dextran, rhodamine, or gadolinium salts. The administration of other substances is at the discretion of the attending physician.

[0066] Advantageously, the ear catheter is arranged with a special insertion aid. The insertion aid proposed by the present invention, which is particularly suitable for use with an ear catheter, has three parts, namely a headpiece, an intermediate piece, and an end piece, and is provided with a separation line extending longitudinally along at least some of the parts, thereby allowing corresponding parts of the insertion aid to be opened longitudinally.

[0067] In other words, the key inventive concept in the insertion aid is to provide an insertion aid that allows a specific or all part of the insertion aid to be at least partially removed from a positioned catheter by having one or more separation lines extending longitudinally. In this case, the separation lines may extend across individual parts, multiple parts, or all parts of the insertion aid. The separation lines may be formed to be continuous with each other, that is, one consistent separation line may be provided across multiple parts or all parts, or multiple separation lines may be provided in different positions and configurations for each part.

[0068] In the sense of the present invention, the separation line may be a weakening line in the material of the insertion aid having relatively low strength at this location. Such a weakening line may be created, for example, by laser processing, but advantageously by mechanical cutting or by a perforation line that facilitates tearing along the line.

[0069] Such cuts may extend, for example, over 40-70% of the wall thickness of the insertion aid in this section. In this case, separation occurs only after user action.

[0070] However, the separation line in the sense of the present invention may also be an existing opening, for example, if a corresponding part is manufactured from multiple parts, the material is already completely separated at the corresponding point at this opening. In this case, the separation is not first performed by the user. Rather, the individual parts are joined by different connecting members, which will be described further.

[0071] Insertion aids are made of materials that are substantially rather rigid, generally polymers. Suitable polymers in medical technology are well known, and thermoplastics and thermoplastic elastomers, such as polyether block amides (Pebax), are particularly considered. Some degree of flexibility facilitates insertion, but excessive flexibility means a loss of guiding ability.

[0072] In a first preferred embodiment, an insertion aid is provided for use with an ear catheter. The headpiece of the insertion aid is bent to allow for the simplest possible placement within the Eustachian tube. The intermediate and end pieces are formed substantially linearly.

[0073] These three parts have typical dimensions; for example, the headpiece is approximately 2.5 cm and the middle piece is approximately 14 cm. The headpiece and middle piece are fully inserted into the body through the patient's nose, while the end piece is left outside the body. The end piece is, for example, 15 cm long.

[0074] It is self-evident that the material of the insertion aid is made of a biocompatible material. Advantageously, this material is transparent.

[0075] The headpiece is typically bent at an angle of, for example, 30° to 80°, and especially around 70°, relative to the extended portion of the intermediate piece.

[0076] In this first embodiment of the insertion aid, two separation lines extend along the length of both the headpiece and the intermediate piece, allowing these portions of the insertion aid to be detached. The end piece itself is divided, meaning it forms two ends that the user can grasp to pull the insertion aid out of the middle ear, Eustachian tube, and nose when inserting the catheter. The separation lines of the headpiece and intermediate piece continue proximal to the separation lines of the two halves of the end piece, so that the user can detach the entire insertion aid by detaching it across the free end. The used insertion aid is discarded.

[0077] It should be noted that, in this context, "distal side" refers to the part of the insertion aid that faces towards the middle ear, while "proximal side" refers to the part that faces away from the middle ear.

[0078] In individual cases, it was found that inserting an ear catheter using the insertion assist means according to the first embodiment could cause stress on the transition portion of the intermediate piece to the end piece, leading to the separation line beginning to rupture. To avoid premature rupture, it is significant to provide a protective member at the proximal end of the intermediate piece to prevent such rupture. A suitable protective member would be, for example, a ring made of adhesive tape, which is torn by the user before the insertion assist means is removed. For this purpose, the adhesive tape is advantageous in that it has a non-adhesive free end on one side to facilitate removal.

[0079] In practice, after positioning the catheter, the user grasps the two free ends of the end piece of the insertion aid, and then pulls out the intermediate piece and head piece covering the catheter from the patient's body. At this time, the intermediate piece is first slit along the separation line, and then the head piece is slit. This separates the insertion aid from the catheter.

[0080] In the second preferred embodiment, the insertion aid can also be used in conjunction with the ear catheter. For this purpose, the headpiece may be bent as described above, thereby allowing for the simplest possible placement of the insertion aid within the Eustachian tube. The intermediate and end pieces are formed substantially linearly.

[0081] In this case, the same applies to other configurations relating to the first embodiment, relating to the dimensions and preferred materials of the insertion assist means.

[0082] The second preferred embodiment differs from the first preferred embodiment, particularly in terms of the mechanism for separating the insertion assisting means from the catheter. In the second embodiment, the separation of the insertion assisting means from the catheter is performed, in particular, by opening the insertion assisting means.

[0083] Accordingly, the insertion assist means according to this second embodiment is provided in a way that allows it to be opened and preferably consists of two parts, that is, it is divisible into two halves in the longitudinal direction. The separating line is provided here as a continuous slit, as described above. The two halves are preferably provided as mirror-image identical halves. However, the insertion assist means may also be composed of three or four equal parts, or in other proportions, rather than consisting of such mirror-image identical halves. However, mirror-image identical halves are preferred.

[0084] The halves are preferably permanently joined to each other at at least one location so that when opened along the separation line, the halves do not separate into two distinct parts. The corresponding connecting member may be provided, for example, in the form of a hinge. Such a hinge is preferably provided in the area of ​​the end piece and joins the two halves. The hinge may already be provided between the two halves, for example by a corresponding injection molding method, during the manufacture of the operating aid, or the hinge may be joined later, only after the manufacture of the two halves.

[0085] As described above, in an embodiment consisting of multiple longitudinal sections, a corresponding hinge is provided between the longitudinal sections.

[0086] Instead of a hinge, other connecting members may be provided to join the longitudinal portions of the insertion aid. Such connecting members do not necessarily need to create a permanent connection; it is sufficient that they securely hold the individual longitudinal portions together during catheter placement.

[0087] The combination of hinges and other connecting members is equally significant. For example, secure connection of the insertion aid may be achieved by at least one hinge provided on the end piece, and other connecting members may be provided to support the intermediate piece and the end piece or head piece.

[0088] In this case, the other connecting member may be, for example, a locking member or a click member, and the corresponding members are located in the longitudinal portion to which they are to be joined. In other words, in this case, the other connecting member is preferably part of an insertion assisting means.

[0089] However, other coupling members, for example, in the form of rings, may also be considered, which are provided on the corresponding longitudinal portion of the insertion assisting means and can be separated, for example, at a target fracture site provided for that purpose, in order to open the insertion assisting means. The other coupling members may be provided in the form of the protective members described above.

[0090] A second embodiment of the insertion assist means is also conceivable as a reusable product, based on a non-destructive opening mechanism with respect to the main components. Accordingly, a more robust configuration can be pursued, particularly in the configuration of the end piece, which enables a particularly comfortable feel for the user, for example, by using a specially molded gripping area. Similarly, the end piece may be provided with a reusable coupling member, for example in the form of a lock, which allows the closed or bundled end piece to be opened and closed repeatedly.

[0091] In one alternative configuration of the second embodiment, only the intermediate piece and end piece are provided in an openable manner. In contrast, the head piece is provided integrally in a tubular shape and can be connected at its proximal end to the distal end of the intermediate piece via a connecting member.

[0092] The connecting member may be provided, for example, as a screw thread. Accordingly, the headpiece has a male or female screw thread, and the intermediate piece has a corresponding member. It is also conceivable that the connecting member exists in the form of a separate component, that is, as a screw thread member into which the headpiece and intermediate piece are screwed. In this case as well, the arrangement of the male and female screw threads that fit together will be selected by those skilled in the art according to the requirements at the time. A preferred embodiment is one in which the headpiece and intermediate piece have male screw threads, and these male screw threads are screwed into the female screw threads of the connecting member.

[0093] For example, other connecting members in the form of special force-coupled click or locking members are also conceivable.

[0094] In this case, the connecting member is additionally used as a connecting member by joining two parts: an intermediate piece and an end piece connected to it.

[0095] Therefore, in the alternative second embodiment of the insertion assist means, the headpiece remains on the catheter after the removal of the intermediate and end pieces and is moved to the proximal catheter end, and can then be used, for example, as a fixation assist means to fix the proximal catheter end, for example, behind the patient's ear.

[0096] An alternative second embodiment of the insertion aid also offers the advantage of interchangeable headpieces. In this case, the corresponding set may include multiple headpieces of different angles, each added to the basic components of such insertion aid, i.e., the unit consisting of an intermediate piece and an end piece. In this case, the user can select from these different headpieces the one best suited to the role at hand. In this case, various variations are possible regarding the angle of the headpiece, the length of the headpiece, or the material, which may be particularly stable or flexible.

[0097] Accordingly, such a set may also include a headpiece that is not necessarily related to ear treatment and is therefore suitable for use in combination with other catheters.

[0098] In other words, an alternative second embodiment of the insertion assist means may be envisioned as a combination product including a reusable base component with a replaceable headpiece and a disposable headpiece.

[0099] A second embodiment may optionally have an additional tubular sheath attached to the headpiece and / or intermediate piece, which is in close contact with these parts. The sheath provides an additional retaining means to the two-part headpiece and / or intermediate piece by firmly holding the two halves of these components together. The sheath may be provided as a single unit or in multiple parts, and may be attached to various points on the headpiece and / or intermediate piece. The sheath may be provided only in an annular shape, that is, it may not be provided as a relatively long or continuous tube.

[0100] A perforation line may be provided to open and remove the sheath. However, such perforations are particularly useful for ease of operation. Without corresponding perforations, the sheath can also be removed by the user either by cutting or tearing it longitudinally. The material of the sheath can be appropriately selected.

[0101] Since the sheath is inserted along with the treatment, a low-friction material is particularly advantageous in this case. Various plastics, such as PTFE or ePTFE, are well known to those skilled in the art.

[0102] The present invention particularly relates to the use of an insertion aid for inserting an ear catheter, as described above. The present invention further relates to a combination of an insertion aid and an ear catheter that are dimensionally matched to each other. In this case, the ear catheter may already be assembled and inserted into the insertion aid.

[0103] Although the present invention has been described above in relation to its use in ear catheters and for positioning catheters within the Eustachian tube, the use of the insertion assist means according to the present invention is not limited to these areas. Rather, the use of the insertion assist means according to the present invention is significant wherever removal of the insertion assist means after successful positioning is no longer possible without difficulty toward the distal or proximal side covering the catheter for the reasons described above.

[0104] The potential uses and application fields of the insertion aid according to the present invention are not limited to use for ear catheters in the nasopharynx. Rather, the insertion aid according to the present invention can be adapted to various applications or locations of use, particularly through the configuration of its individual parts, such as the headpiece, intermediate piece, and endpiece.

[0105] For this reason, these parts are variable in dimensions such as their length and diameter, or in their bending, or specific, for example, somewhat flexible materials are selected according to the requirements of a particular place of use.

[0106] The present invention and the technical environment will be described in more detail below with reference to the drawings. It should be noted that the drawings illustrate one particularly preferred embodiment of the present invention. However, the present invention is not limited to the illustrated embodiment. In particular, the present invention includes any combination of technical features described in the claims or described in the specification as important to the invention, insofar as they are technically significant. [Brief explanation of the drawing]

[0107] [Figure 1] This is an overall diagram of a first preferred embodiment of an ear catheter according to the present invention, which is equipped with a shielding body as an occlusion member. [Figure 2] Figure 1 shows detailed views of the proximal and distal portions of a preferred embodiment. [Figure 3] This is another detail view of the distal portion of another preferred embodiment. [Figure 4] This figure shows various contours of possible shielding shapes. [Figure 5] This figure shows various methods for connecting the proximal shield portion to the catheter tube. [Figure 6] This is a schematic diagram of one preferred embodiment, which includes a balloon as a closure member. [Figure 7] This is a detailed view of the proximal end of the embodiment shown in Figure 6. [Figure 8]This is another detailed view of the proximal end of the embodiment shown in Figure 7. [Figure 9] This is another detailed view showing a variation of the proximal end of the embodiment shown in Figure 7. [Figure 10] This figure shows a first embodiment of the insertion assisting means according to the present invention. [Figure 11] This diagram shows the usage and removal principle of the first embodiment of the insertion assisting means. [Figure 12] This figure shows the extension of the separation line in the first embodiment. [Figure 13] This figure shows a first embodiment of the insertion assisting means according to the present invention, which is equipped with a means for preventing tearing. [Figure 14] This figure shows a second embodiment of the insertion assisting means according to the present invention in an open state. [Figure 15] This is a perspective view showing one alternative configuration of a second embodiment of the insertion assisting means according to the present invention. [Figure 16] This is a plan view showing the inner surface of half of the insertion assisting means shown in Figure 14. [Figure 17A] This is a detailed view of Figure 16. It shows a longitudinal cross-sectional view of the distal end of the headpiece. [Figure 17B] This is a detailed view of Figure 16. The connecting members are shown in a longitudinal cross-sectional view along with the ends of the headpiece and intermediate piece. [Figure 17C] This is a detailed view of Figure 16. It shows an expanded area proximal to the end piece that facilitates the insertion of a catheter (not shown) into the insertion assist mechanism. [Figure 18] Figure 16 is a perspective view showing the item with a sheath. [Figure 19] This is a detailed view of a partial perspective of the viewpoint shown in Figure 18. [Modes for carrying out the invention]

[0108] The ear catheter 1 according to the present invention, shown in Figure 1, has a catheter tube 3, the distal end d of the catheter tube 3 is provided with a self-inflating shield 2. The proximal end p of the catheter tube 3 is located on a conventional Luer lock connector 5 for a syringe, which allows the drug to be administered to be introduced through the injection lumen 3A. The proximal end may further have an additional connector for a pressure relief lumen (not shown). In this embodiment, the only lumen of the catheter 3 is the injection lumen 3A, however, a preferred embodiment is one in which the catheter includes another lumen for pressure relief in addition to the injection lumen 3A, as shown in the following Figure 3.

[0109] The ear catheter 1, as a whole, has a length of approximately 15 cm to 30 cm, with a catheter tube 3 preferably having an outer diameter of 2 to 3 mm and an inner diameter of approximately 1 mm for the injection lumen.

[0110] A tubular inflation device 6, provided around the catheter tube 3 by shape coupling or friction coupling, is used to inflate or compress the shielding body 2. The inflation device 6, like the catheter tube, is preferably made of plastic.

[0111] An operating assist means 7 is provided at the proximal end p of the inflation device 6 to simplify its operation. This is because the operating assist means 7 enables reliable intervention in the inflation device 6 and, consequently, reliable control of the inflation device 6.

[0112] The expansion device 6 is used to expand or contract the shielding body 2. When the expansion device 6 is pushed and shifted distally d to cover the shielding body and is placed there, the shielding body 2 becomes compressed. When the expansion device 6 is pushed and shifted downward from the shielding body 2 toward the proximal side p and is placed there, the shielding body 2 becomes expanded.

[0113] To prevent unintended inflation of the shielding body 2 due to slippage of the inflation device 6 while the ear catheter 1 is being positioned through the nose and nasopharynx, a spacer may be provided between the Luer lock 5 provided at the proximal end p of the ear catheter 1 and the operating assist means 7 of the inflation device 6. The spacer may be provided as a slitted tube, which can be removed and then reattached (not shown).

[0114] Figure 2 shows details of the distal end d and proximal end p of the ear catheter 1. The distal end d of the ear catheter 1 is provided with a self-inflating shield 2. This shield 2 preferably consists of three parts 2A, 2B, and 2C, namely a distal part 2A having a large diameter, which extends cylindrically over a predetermined length without significantly tapering and forms a portion of the shield 2 that substantially creates fluid-tight contact with the wall of the Eustachian tube. Any proximal part 2C is provided in a tubular shape to securely fix the shield 2 within the distal lumen of the catheter tube 3.

[0115] Therefore, it is desirable that the open diameter of the catheter tube 3, including the injection lumen 3A and the pressure relief lumen (not shown), be reduced only slightly so as not to interfere with fluid administration and pressure compensation. Between the proximal portion 2C and the distal portion 2A, there is an intermediate portion 2B, which is formed in a funnel or conical shape and widens from the smaller diameter of portion 2C to the larger diameter of portion 2A.

[0116] The configuration of the shielding body 2, that is, the ratio of self-expanding support members or frames on the one hand and the ratio of membranes on the other hand, can be variable over sections 2A to 2C. Preferably, to ensure the best possible closure, the membrane is manufactured as a single unit and extends over all sections 2A to 2C.

[0117] To ensure that the space between the shield 2 and the wall of the eartube can be sealed as tightly as possible, a cylindrical portion 2A may be provided distally for a predetermined length. This portion includes a membrane as well as a plurality of self-expanding support members, which are preferably provided as meandering ring segments and may exist together as a single frame or as separate support members. However, the distal portion 2A is optional, and an embodiment is also conceivable in which the distal end of a conical portion 2B simultaneously forms the distal end of the shield 2.

[0118] Sections 2A-2C can be supported entirely or partially by multiple self-inflating support members or a single connected frame. The structure and design are variable in the individual sections 2A-2C. That is, the important thing at the distal end d of the shield 2 is that a sufficient, but not excessively high, radial force is achieved that seals the space between the shield 2 and the Eustachian tube as tightly as possible, while simultaneously preventing pressure marks or necrosis. Accordingly, the distal end of section 2B and / or any section 2A can be formed. In other respects, the conical section 2B does not need to have a corresponding radial force, but the conical section 2B is particularly useful in preventing the reflux of medication from the Eustachian tube into the nasopharynx. Accordingly, if section 2A is present distally, a section 2B without a frame structure or corresponding support members is also conceivable. The same applies to part 2C, which is ultimately used solely for fixing the shielding body 2 within the catheter tube 3, and it is also possible to fix the shielding body 2 within the catheter tube 3 solely by a connection between the membrane and the catheter tube 3.

[0119] An embodiment is conceivable in which a complete shielding body 2 is formed by one inner frame and / or a plurality of corresponding support members and a membrane coupled thereto. A person skilled in the art can find corresponding combinations of shielding body portions 2A to 2C, including one frame and / or a plurality of support members in addition to the membrane, according to the requirements of the time, regardless of the invention.

[0120] An inflation device 6, which is provided in a tubular shape around the catheter tube 3, has an operating assist means 7 at its proximal end, which optionally facilitates the forward and backward movement of the inflation device 6. In one preferred embodiment, a locking device 8 may be provided that can detachably connect the operating assist means 7 to a Luer lock system 5 in order to prevent displacement of the operating assist means 7 and, in particular, compression of the shield 2 when the shield 2 is inflated.

[0121] The inflation device 6 is preferably provided in a tubular or cylindrical shape. For example, in order to increase the flexibility of the ear catheter 1, an embodiment is conceivable in which the inflation device 6 is provided with at least a partial slit.

[0122] The operating assistance means 7 may be provided in an annular shape, and in this case, embodiments in which slits are also formed here, or holding members provided only at predetermined locations on the expansion device 6 are also conceivable.

[0123] To prevent the administered fluid from flowing back through the injection lumen 3A, a check valve 4 is preferably provided at the distal end of the injection lumen 3A. A corresponding valve is also provided for the pressure relief lumen (not shown).

[0124] During the procedure, a catheter is placed against the ear and a occluding device is inflated. Then, medication is injected into the middle ear via a syringe and left there for the required time. The filling of the middle ear is monitored using an ear microscope. The procedure is preferably performed under local anesthesia, but general anesthesia may be recommended in special cases. After the medication is administered, the proximal end of the administration catheter is attached to the cheek with an adhesive bandage. The occluding device remains in place within the Eustachian tube, preventing the injected solution from leaking out. After the treatment is complete, the occluding device is compressed and the catheter is withdrawn.

[0125] Figure 3 shows one other preferred embodiment of an ear catheter 1 comprising an injection lumen 3A and a pressure relief lumen 3B. The catheter tube 3 terminates distally with a non-traumatically molded tip 12, in which case the injection lumen 3A terminates distal to the non-traumatically molded tip 12 with an opening 3C, and the pressure relief lumen 3B terminates proximal to the non-traumatic tip 12 with an opening 3D. Unlike the embodiment shown in Figure 2, at least a portion of the catheter tube 3 is guided through the shield 2 by the injection lumen 3A and the pressure relief lumen 3B, and terminates only distal to the shield 2.

[0126] Figure 4 shows contour diagrams of various possible configurations of the shielding body 2 in Figures A to H, where the distal end is located on the left and the proximal end is located on the right. Each contour corresponds to a combination of frame and membrane; that is, the contour of the shielding body 2 may be substantially determined by the frame, membrane, or a combination thereof, alternatively.

[0127] Figure 5 illustrates in detail various possibilities for the connection means 9 between the proximal shield portion 2C and the catheter tube 3. Figure 5A shows a connection means 9 comprising a plurality of locking members 9A, preferably cured by injection molding. Figure 5B shows an adhesive connection means 9 in which the catheter tube 3 reaches into the proximal end of the shield 2C and is bonded to the shield 2. To further stabilize the adhesive connection means 9, the proximal end 2C of the shield may have a plurality of punched portions 9B. Alternatively, this connection means may be formed as a purely shape-connection means. Figure 5C shows a shape-connection type connection means 9 optionally comprising additional retaining members 9C, which increase frictional resistance and thereby further prevent the shield from slipping out. In this embodiment, the catheter tube 3 surrounds the distal end 2C of the shield. This connection means may be additionally provided as an adhesive connection means. Figure 5D shows a screw-type connecting means 9 equipped with a threaded connector 9D, in which case the male thread may be the distal end 2C of the shielding body and the female thread may be the catheter tube 3, or vice versa.

[0128] Figure 6 shows an overall view of a preferred embodiment of an ear catheter 1 equipped with a balloon as an occlusion member 2. The proximal end of the catheter 3 is equipped with three connectors: a connector 10C for inflating the balloon, a connector 10A for connecting a syringe to the injection lumen, and a connector 10B for pressure compensation via the pressure relief lumen. The distal end of the catheter 1 is provided with a non-traumatic tip 12.

[0129] Figure 7 shows a detailed view of the distal catheter portion, which includes a non-traumatic tip 12, a balloon 2 located proximal to it, and three markers attached proximal to the balloon to determine the position of the ear catheter using an endoscope during placement.

[0130] Figure 8 shows a detailed view of a first preferred embodiment of the distal portion of the catheter tube 3, in which the injection lumen 3A terminates with an opening 3C at the distal end of the non-traumatic tip 12, and the pressure relief lumen 3B is laterally shifted at the non-traumatic tip 12 and terminates with an opening 3D. The inflation lumen 3E terminates open in the area of ​​the balloon 2 (3F).

[0131] Figure 9 shows one other preferred embodiment of the distal portion of the catheter tube 3, in which the pressure relief lumen 3B terminates with an opening 3D distal to the balloon 2, but proximal to the tip (not shown). The inflation lumen 3E terminates in the region of the balloon 2 (the injection lumen is not shown here).

[0132] Figure 10 shows an insertion assisting means 101 according to the present invention, comprising a bent headpiece 102, a straight intermediate piece 103, and an end piece 104 divided into two arms. The headpiece 102 is ideally bent by approximately 70° relative to the intermediate piece 103 (displayed differently). The 70° angle is created relative to the extended portion of the intermediate piece 103.

[0133] The end piece 104 is divided into two arms, which are used by the treating physician as handles to split the insertion aid 101 over a predetermined length. Following the division, a separation line or seam 105 extends over a predetermined length of the intermediate piece 103 and the head piece 102, formed as a weakening zone, for example by a partial cut.

[0134] The insertion assist means 101 is manufactured from a biocompatible polymer and has sufficient rigidity with respect to the required guiding properties. At the same time, the polymer should not provide excessive resistance to the tearing process. Considerations include common polymers such as polyamides and polypropylene, or copolymers such as Pebax.

[0135] Figure 11 shows the sequence, with Figure A showing an ear catheter 106 inserted into the patient's nose via an insertion assist device 101, along with a connected pressure generator 107; Figure B showing the removal of the insertion assist device 101 covering the catheter tube from the patient's nose; Figure C showing the insertion assist device 101 already completely removed from the patient's nose; Figure D showing the insertion assist device 101 further cleaved; Figure E showing the insertion assist device 101 cleaved down to the distal headpiece 102; and Figure F showing the insertion assist device 101 completely cleaved and deemed for disposal.

[0136] Figure 12 shows an insertion assisting means 101 according to the present invention, comprising a distal headpiece 102, an intermediate piece 103, two arms of an end piece 104, and a separation line 105 drawn with a dashed line. The separation line 105 continues along the entire length of the intermediate piece 103 and the end piece. The separation line 105 begins at the point where the two arms of the end piece 104 meet. It is obvious that a corresponding separation line 105 exists on the opposite side as well.

[0137] Figure 13 shows the proximal region of the insertion assisting means 101 according to the present invention, which has a protective member 108 attached to the proximal end of the intermediate piece 103. The protective member 108 is an adhesive tape that surrounds the insertion assisting means 101 at the illustrated location to prevent premature tearing along the separation line 105. Before tearing of the insertion assisting means 101, the adhesive tape 8 is removed by the treating physician.

[0138] Figure 14 shows a second embodiment of the insertion assisting means according to the present invention in an open state, comprising a first half A including half of the headpiece 102', half of the intermediate piece 103', and half of the end piece 104', and a second half B including half of the headpiece 102, half of the intermediate piece 103, and half of the end piece 104. In this example, halves A and B of the insertion assisting means 101 are molded identically to each other, mirror images of each other.

[0139] When the headpieces 102, 102' are used as insertion aids for ear catheters, they are preferably bent by approximately 70° relative to the intermediate pieces 103, 103' (the illustration here differs). The 70° angle is created relative to the extension of the intermediate pieces 103, 103'. Thus, the angle of the headpieces 102, 102' relative to the intermediate pieces 103, 103' is 0°, which corresponds to the overall straight extension of the intermediate pieces 103, 103' and the headpieces 102, 102'.

[0140] Half sections A and B are joined to each other via a connecting member 111 in the region of end pieces 104 and 104', preferably in the gripping region 112 and 112'. The connecting member 111 preferably continuously connects the portions of both end pieces 104 and 104' or both gripping regions 112 and 112', and is preferably already provided during the manufacture of the insertion assisting means 101, however alternatively, each portion 104 and 104' or 112 and 112' or both half sections A and B, which were initially manufactured unconnected, may be connected to each other for the first time later.

[0141] The end pieces 104 and 104' are further provided with additional connecting members 110A and 110B in the form of locking and closing means, in which case the locking members 110A and 110B that fit together with each other are each provided at corresponding locations on the end pieces 104 and 104'.

[0142] A continuous passage extends through the insertion assist means 101, allowing the catheter to be guided through this passage. The passage gradually widens at the proximal ends of the end pieces 104, 104', thereby facilitating the insertion of a catheter (not shown) into the insertion assist means 101.

[0143] Figure 15 shows a perspective view of one alternative configuration of a second embodiment of the insertion assisting means 101 according to the present invention. This alternative configuration differs only in the arrangement of the headpiece 102, which is formed as an undivided tube rather than being divided into two parts. The headpiece is connected to two divided intermediate pieces 103, 103' via a connecting member 109. The connecting member 109 is provided in the form of a sleeve that surrounds the proximal portion of the headpiece 102 and the distal portions of the intermediate pieces 103, 103'. To connect the headpiece 102, the connecting member 109, and the intermediate pieces 103, 103', for example, a force-coupled insert joint or a threaded joint may be provided.

[0144] In other words, the connecting member 109 is also used as another connecting member for the intermediate piece halves 103 and 103'.

[0145] The configuration of the other components of the insertion assisting means 101, particularly the end pieces 104, 104' with another connecting member 110, corresponds to the second embodiment shown in Figure 14.

[0146] Figure 16 shows a plan view of the inner surface of one half of the insertion assisting means 101 shown in Figure 15, viewed longitudinally. Since the individual components substantially correspond to the components shown in Figure 14, please refer to Figure 14 as appropriate. This figure of the alternative configuration shows, as a difference, the arrangement of the connecting member 109, which is provided as a sleeve surrounding the ends of the headpiece and the ends of the intermediate piece, which are arranged opposite each other.

[0147] Figure 17 shows a detailed view of a specific part of the alternative second embodiment shown in Figures 15 and 16.

[0148] Figure 17A shows a longitudinal cross-sectional view of the distal end of the headpiece.

[0149] Figure 17B shows the connecting member 109 in a longitudinal cross-sectional view, along with the ends of the headpiece 102 and the intermediate piece 103. These three members are joined via threads, specifically the female threads on the connecting member 109 and the male threads on the corresponding areas of the headpiece 102 and the intermediate piece 103.

[0150] Finally, Figure 17C shows an expanded area proximal to the end piece 104 that facilitates the insertion of a catheter (not shown) into the insertion aid.

[0151] Figure 18 shows a perspective view of an alternative configuration of a second embodiment of the insertion assisting means 101 according to the present invention shown in Figure 15. This embodiment additionally includes a sheath 113 provided on and in close contact with the headpiece 102 and / or intermediate piece 103. The sheath 113 provides an additional retaining means to the two-part headpiece 102 and / or intermediate piece 103 by bringing together the two halves of these components.

[0152] Figure 19 shows a portion of the sheath 113 in detail. A perforation line 114 may be provided for opening and removing the sheath 113. However, such perforations can be omitted without issue, particularly for ease of operation. The sheath can also be removed by the user by selectively cutting or tearing it longitudinally. [Explanation of Symbols]

[0153] 1. Ear catheter 2. Shielding element (A: distal part; B: intermediate part; C: proximal part) 3. Catheter tube (A: Injection lumen; B: Pressure relief lumen; C: Distal opening of the injection lumen; D: Distal opening of the pressure relief lumen; E: Expansion lumen; F: Distal opening of the expansion lumen) 4. Check valve 5. Connection device (Luer lock system) 6. Expansion device 7 Operation aids 8 Locking device 9 Connection means 10. Proximal connector (A: injection lumen; B: pressure relief lumen; C: expansion lumen) 11 Markers (A: First marker; B: Second marker; C: Third marker) 12. Non-traumatic tip 101 Insertion assist means 102 Headpiece (102 First Half, 102' Second Half) 103 Intermediate piece (103 First half, 103' Second half) 104 End Piece (104 First Half, 104' Second Half) 105 Separation line 106 Catheter 107 Pressure Generator 108 Protective component 109 Connecting member 110 Another connecting member (110A, 110B Part of another connecting member) 111 Connecting member 112 Gripping area (112 first part, 112' second part) 113 Sheath 114 Perforation Line d Distal side p proximal side

Claims

1. An insertion aid for an ear catheter, comprising a headpiece (102, 102'), an intermediate piece (103, 103'), and an end piece (104, 104'), wherein the insertion aid (101) is made of a biocompatible polymer, An insertion aid for an ear catheter, characterized in that at least one separation line (105) extends through at least the intermediate pieces (103, 103') and the end pieces (104, 104'), and the insertion aid (101) can be opened or split along the separation line (105).

2. The insertion assist means for an ear catheter according to claim 1, characterized in that at least the intermediate piece (103, 103') and the end piece (104, 104') of the insertion assist means (101) are divided into two longitudinal portions (A, B) by two opposing separation lines (105).

3. The insertion assist means for an ear catheter according to claim 1 or 2, characterized in that the headpiece (102) of the insertion assist means (101) is integrally provided in a tubular shape, and the proximal end of the headpiece (102) can be connected to the distal end of the intermediate piece (103, 103') via a connecting member (109), and the intermediate piece (103, 103') and the end piece (104, 104') form a single basic member.

4. The insertion aid for an ear catheter according to claim 2, characterized in that the end piece (104, 104') has a connecting member (111) that connects the two longitudinal portions (A, B) to each other.

5. The insertion aid for an ear catheter according to claim 4, characterized in that the end piece (104, 104') is positioned on the side opposite to the connecting member (111) and has another connecting member (110) that connects the two longitudinal portions (A, B) so that they can be separated from each other.

6. The insertion assist means for an ear catheter according to claim 1, characterized in that two continuous separation lines extend through the headpiece (102, 102') and the intermediate piece (103, 103'), allowing the insertion assist means (101) to be divided along the separation lines, and the end piece (104, 104') is divided into two following the separation line (105).

7. An insertion aid for an ear catheter according to any one of claims 1 to 6, characterized in that a protective member (108) is provided at the proximal end of the intermediate piece (103).

8. An insertion aid for an ear catheter according to any one of claims 1 to 6, characterized in that a tubular sheath (113) is provided around the intermediate piece (103) and / or the head piece (102).

Images