RU2848404C1 - Ear catheter and device for inserting the catheter - Google Patents

Abstract

FIELD: medical technology.

SUBSTANCE: invention relates to an ear catheter designed for administering medication into the auditory tube. The ear catheter for insertion into the auditory tube has a first tube as a catheter tube, which has at least one first lumen as an injection lumen for administering fluid, at least one second lumen as a decompression lumen for pressure relief, and a self-expanding sealing element for closing the auditory tube. The sealing element is provided at the distal end of the catheter tube in the form of a screen, and an expansion device is provided to control the expansion of the screen. The screen comprises self-expanding support elements and/or a self-expanding frame and a membrane fixed thereto.

EFFECT: catheter is easy to use and, in particular, does not cause irritation in the auditory tube, even during prolonged use, or causes only minor irritation.

10 cl, 19 dwg

Description

The invention concerns an ear catheter with a seal for introducing medication into the eustachian tube and a catheter insertion device comprising a head, a middle section, and a tip. The insertion device is comprised of a polymer capable of being incorporated into the body. The insertion device serves, in particular, to facilitate placement of the ear catheter through a patient's nose into the middle ear.

Numerous diseases of the middle and inner ear require topical treatment. Since topical treatment is required, it can be administered either through the eardrum or the eustachian tube. Treatment of the inner ear can also be performed through the middle ear. A nasal ear catheter is often used for treatment, as is medication administration. However, administering liquid medications into the eustachian tube or middle ear is ineffective, as the medication can quickly drain through the eustachian tube into the nasopharynx.

A number of infections, inflammations, as well as treatments for deafness or Ménière's disease, require long-term treatment, which can last for days or weeks. Typically, this involves continually administering a new medication, such as a corticosteroid. This treatment is time-consuming and requires regular and long-term medical monitoring and care.

For this reason, it would be desirable to have an ear catheter available to administer medication into the auditory tube and maintain it there in sufficient quantity for a long period of time. This administration should be performed as non-invasively as possible, meaning without damaging the eardrum. In this case, only natural access through the nasopharynx and auditory tube (eustachian tube) is possible.

DE 102018102937 A1 describes a corresponding ear catheter that can be inserted into the eustachian tube through the nasopharynx and includes an expandable balloon for sealing. An injection channel extends through this balloon, allowing medication to be injected distally into the eustachian tube, while the balloon prevents backflow into the nasopharynx.

The existing ear catheter has various drawbacks. First, it lacks pressure compensation distally from the balloon, which could offset the excess pressure in the middle ear caused by the introduction of the fluid. Furthermore, the existing ear catheter lacks any markers that would allow the user to accurately determine the position of the inserted catheter. Furthermore, the balloon, which is intended as a sealing element, can in some cases create pressure points. This is unlikely to be prevented by the balloon pressure limitation provided in some cases and the selection of a highly adaptive balloon, as at least some pressure must be applied to achieve the balloon's sealing effect. Furthermore, handling an ear catheter with an inflatable balloon is relatively difficult, as an additional tool is always required for inflation (and deflation).

Inserting an ear catheter through a patient's nose, particularly when the catheter is made of a highly flexible material, is challenging. An insertion device would be desirable. However, using an insertion device is problematic when the treatment catheter must remain in place in the middle ear or eustachian tube for extended periods, as there is typically a proximal connection for the catheter to another device, such as an infusion bottle or pressure device. In this case, the insertion device cannot simply be pulled proximally along the catheter tube, as the connector for another device or the other device itself is located there. Distal retraction of the insertion device is also impossible, as the catheter's distal end is anchored to the target structure, such as the eustachian tube.

The object of the invention is therefore to provide an ear catheter having a seal which does not have at least some of the above mentioned disadvantages, is easy to handle and, in particular, does not create or only creates minor irritation in the auditory tube even when left in place for a long period of time.

It is also an object of the invention to provide

an insertion device by means of which a catheter, for example an ear catheter, can be inserted simply and quickly, for example through the nose, into the auditory tube of a patient and, after placement of the catheter, can be withdrawn again at least in parts without the need to remove the catheter or the device connected thereto.

The problem is solved using a device according to independent claims 1 and 13 of the invention formula. Other embodiments of the invention are shown in the dependent claims.

The problem is solved by the proposed invention of an ear catheter, which has a catheter tube with an injection lumen for administering medications and a decompression lumen for relieving pressure in the middle ear, as well as a self-expanding sealing element.

This ear catheter can be non-invasively inserted through the nose and nasopharynx into the eustachian tube and positioned so that the sealing element, after dilation, forms a fluid-tight seal across the eustachian tube toward the pharynx. The sealing element seals the connection between the middle ear region distal to the nasopharynx proximal to the sealing element, preventing fluids injected through the injection lumen ending distal to the sealing element from flowing into the nasopharynx.

"Distal" in the context of the present invention means the portion of the device pointing along the catheter or, respectively, the insertion device away from the user, while "proximal" means the portion pointing along the catheter or, respectively, the insertion device toward the user. Further details of the relative positioning are contained in the figures.

The sealing element may be an inflatable balloon or, in one preferred embodiment, also an expanding screen.

The injection channel runs continuously from the distal to the proximal end of the catheter tube and terminates distally behind the sealing element.

The decompression lumen also begins at the proximal end of the catheter tube and terminates distally behind the sealing element. The exact position of the distal opening of the decompression lumen distal to the sealing element may vary; functionally, it is only important that the distal outlet also be located distal to the sealing element.

Other lumens may be provided in the catheter tube, such as a lumen to serve as another injection lumen or a lumen, such as to accommodate a removable support wire to stabilize the catheter tube during placement.

In addition to these lumens, the catheter tube includes at least one other lumen as an inflation lumen when an inflatable balloon is provided as a sealing element.

Conventional materials familiar from catheter technology can be used for the catheter tube. These typically include medically approved plastics, such as PVC, polyethylene, polypropylene, and the like. These materials must be flexible enough to allow the catheter to be inserted into the eustachian tube.

The cylinder can also be made from conventional materials that are commonly used in medical technology for cylinders.

The screen proposed by the invention includes self-expanding support elements covered by a membrane. The screen as a whole can be reversibly converted from a compressed to an expanded state. This allows for the screen to be repositioned, as may be necessary in some cases.

The self-expanding support elements may be in the form of separate, unconnected support elements, such as in the form of a plurality of ring-shaped or spoke-shaped segments.

Preferably, however, the self-expanding support elements are at least partially interconnected and formed into a scaffold, such as a vessel support or stent. These self-expanding support elements, or the scaffold itself, can be laser-cut from a tube or as a woven structure.

Well-known shape-memory materials, also used in other self-expanding implants, are proposed as frame materials. These include spring steels, nitinol compounds, or polymers. However, the screen frame materials should not be absorbent, so as not to compromise the stability of the screen.

Since the shield of the ear catheter proposed by the invention serves solely as a seal and not to hold any lumen open, as with other vessel supports, only a low radial force is necessary. High radial forces should even be avoided, as they can create pressure points and necrosis in the sensitive auditory tube. Known materials allow for very precise adjustment of these radial forces.

The self-expanding support elements, or the scaffold, are covered with a membrane. This membrane is waterproof. Suitable waterproof biocompatible films, also known from other membrane-containing implants, such as stent grafts, are suggested as membrane materials. Various plastic membranes are particularly suitable, such as those made of PTFE (polytetrafluoroethylene) or ePTFE (expanded polytetrafluoroethylene).

The membrane must be securely attached to the scaffold, which can be accomplished in various ways, such as by gluing, welding, or using appropriate clamping devices. Combinations of these technologies are also possible. The connection between the scaffold and the membrane must be reliable, but not subject to the same stresses as, for example, stent grafts, as the ear catheter shield is not subject to constant blood flow and serves solely to contain the injected fluid.

Preferably, the membrane is connected with its proximal portion in a liquid-impermeable manner to the distal end of the catheter, as will be described in detail below in connection with the shield.

The screen preferably has a conical or, respectively, funnel-shaped design, having a proximal end of a first diameter and a distal end of a second diameter, wherein the second diameter is greater than the first diameter.

However, many other screen shapes, or screen frame shapes, are possible, which will be described in more detail below using detailed figures.

The shield's proximal end is secured to the distal end of the catheter tube. The shield's primary diameter should be selected to ensure proper connection with the catheter tube, essentially matching the catheter tube's diameter.

Preferably, a fastening device may be provided at the proximal end of the shield, such as a tube or hose extension, which can be positioned within or around the distal lumen of the catheter, thereby providing a fluid-tight connection between the shield and the catheter tube. The diameter of the fastening device should be selected to match the diameter of the catheter, with the outer diameter of the fastening device corresponding, in particular, to the inner diameter of the catheter, or vice versa.

Other connections between the shield and the catheter are possible. These include, but are not limited to, screw connections, locking connections, positive-lock connections, adhesive connections, or injection-molded connections, to name just a few.

In this case, the placement of the screen on the catheter tube should not interfere with the expansion or contraction of the screen by the expansion device, which will be described in more detail later. Therefore, it is best to avoid placing the screen on the outer side of the catheter tube or, accordingly, placing the screen in a way that creates a ridge on the outer side of the catheter.

The shield is preferably installed on the catheter tube, either on the inside of the distal end of the catheter tube or flush with the end of the catheter, i.e., at the distal outlet of the catheter tube, so that the outlet lumens, particularly the injection lumen and decompression lumen, are not obstructed, and fluid administration and excess pressure can still be released. The same applies to the inflation lumen if a balloon is used as a sealing element.

In one alternative embodiment of the variant having a shield as a sealing element, the lumens in the extended section of the catheter tube may also extend distally beyond the distal end of the shield. To prevent injury, particularly in this embodiment and the embodiment having a balloon, an atraumatic tip is provided at the distal end of the catheter tube extended in this manner.

The second screen diameter, or the standard balloon diameter, should be selected so that they at least correspond to the diameter of the eustachian tube at the point they are intended to seal fluid-tight. Preferably, the second screen diameter, or the standard balloon diameter, is slightly larger than the corresponding eustachian tube diameter.

The design of the screen, consisting of a frame and a membrane, is such that the expansion device, which will be described below, can be easily pulled proximally from the compressed screen and moved distally forward onto the expanded screen.

To achieve this, it is proposed to design the screen as a funnel-shaped or, respectively, conical/cone-shaped, that is, with a structure that expands from proximal to distal. At a minimum, the screen should include a corresponding expanding region at the end that attaches it to the catheter tube.

The shape of the screen in its freely expanded state—that is, in a state without external induced forces, either from the expansion device or, for example, from the auditory tube—can be determined by the membrane and/or the frame. Accordingly, at each location, either the membrane, the frame, or the supporting elements limit the maximum possible expansion of the screen.

The screen and the catheter tube are connected to each other in a fluid-tight manner so that fluid introduced through the catheter tube cannot leak proximally between the catheter tube and the extended screen.

The screen can be reversibly converted from a compressed to an expanded state using an expansion device. To achieve this, the expansion device, like the catheter tube, is designed as a tube and encloses the catheter tube in a virtually geometric seal. A fluid-tight seal between the expansion device and the catheter tube is not required. The tightness of the ear catheter is determined by the screen alone.

The expansion device is movable at least axially relative to the catheter tube, allowing for displacement along the catheter tube from the proximal to the distal direction, or vice versa. The expansion device preferably extends from the proximal end of the catheter tube to the maximum location of the shield on the catheter tube and can be moved along the catheter tube beyond the distal end of the shield.

Distal displacement of the dilator causes compression of the screen, specifically when the dilator moves onto the screen attached to the distal end of the catheter tube. Proximal displacement of the dilator causes corresponding expansion of the screen, specifically when the dilator moves downward from the screen, and the screen can then open without external force.

For ease of handling, the expansion device has an optional service element at its proximal end, with which the expansion device can be moved along the catheter.

The ear catheter tube should be approximately 15 cm to 30 cm long. This length should be sufficient to allow the catheter to be inserted through the nostril and nasopharyngeal space into the auditory tube, with the proximal end remaining in the patient's cheek area or, in an alternative embodiment, can also be fixed behind the patient's corresponding ear.

The ear catheter, or injection lumen, is equipped at the proximal end with a connection device for standard syringes, which allows the ear catheter to be filled with a fluid under pressure and the medication solution to be injected into the inner ear. This connection device is conveniently designed using a standard medical luer-lock system, to which various syringes can be attached using appropriate devices.

Accordingly, the decompression lumen at the proximal end of the catheter can also be equipped with a connecting device, but it can also terminate without a special connecting device. This connecting device is conveniently based on the common medical luer-lock system, to which various syringes can be attached using appropriate devices.

Preferably, the expansion device, when the screen is expanded, can be releasably secured to the proximal end of the catheter tube to prevent inadvertent compression of the screen. Preferably, a releasable connection is provided between the expansion device's maintenance element and the luer-lock system. Simple locking elements compatible with each other on the luer-lock system and the maintenance element are conceivable. Other locking devices are possible; a variety of solutions are known to those skilled in the art.

In order to prevent unintentional expansion due to sliding of the expansion device in the proximal direction during placement of the ear catheter through the nose and nasopharyngeal space, a spacer element may be provided between the connecting device at the proximal end of the ear catheter and the servicing device of the expansion device, which may suitably be provided in the form of a slotted tube and thus can be pulled together and put on again.

Naturally, the ear catheter, or, accordingly, the injection lumen, has a closing device that prevents the backflow of the injected medication after filling. Accordingly, the injection lumen has a shutoff valve at either its distal or proximal end, such as a one-way valve, which prevents the injected medication from flowing back through the injection lumen. The outlet orifice of a one-way valve opens according to the injection pressure and then closes again.

The decompression lumen also has a shutoff valve, such as a one-way valve, at either its distal or proximal end, which prevents the injected medication from draining through the decompression lumen. The outlet of a one-way valve opens according to pressure and then closes again.

The closing device may be provided in the form of a simple self-closing valve.

It is preferable to equip the catheter with a handling device for guidance during placement. It is also preferable to provide a curved distal end on the catheter to facilitate guidance and positioning of the catheter into and within the eustachian tube. This curved end is called a "pigtail" on catheters and guidewires and is also common.

The ear catheter proposed by the invention is inserted non-invasively through the nose and nasopharynx into the eustachian tube. Insertion can be monitored with an ear microscope. Once the expandable sealing element, i.e., the shield or balloon, reaches the portion of the eustachian tube to be sealed, it expands when the expansion device is activated.

To assist in positioning the catheter or sealing element, markings may be provided at the distal end of the catheter, but proximal to the sealing element. These markings, or markers for short, may be provided sequentially and endoscopically visible to the treating physician during placement. Multiple markers may be applied, such as marking the first non-critical area of advancement with a green marking, the second area of increased attention with a yellow marking, and the third, critical area with a red marking. The terms "non-critical," "increased attention," and "critical" refer to the progressive penetration of the catheter tip into the inner ear and, with it, increasingly critical proximity to sensitive areas.

The injection lumen terminates distally from the sealing element. At the proximal end, it preferably has a luer-lock syringe connector, through which medication can be injected into the middle ear.

The ear catheter proposed by the invention is particularly suitable for administering antibiotic solutions into the middle ear, which is useful for persistent bacterial infections. Standard treatment for deafness, which involves corticosteroids, can also be effectively administered via such an ear catheter. Standard therapy requires the administration of such a corticosteroid over a long period of time, typically approximately two weeks, with daily administration necessary to ensure the medication drains into the nasopharynx. Treatment typically lasts 14 days. The ear catheter proposed by the invention enables much more intensive and shorter treatment, as it maintains the medication continuously. Therefore, the treatment duration is significantly reduced, in certain circumstances to just a few days. It is particularly suitable for retaining medication in the middle ear for extended periods, particularly several days.

Furthermore, anti-inflammatory medications can also be administered through this ear catheter.

The ear catheter is inserted through one of the nasal openings, in some cases using the insertion device proposed by the invention, and after expansion of the screen and introduction of the medication, it can be secured with a suitable plaster on the cheek or alternatively behind the ear.

An ear catheter remains in the eustachian tube during treatment, keeping the injected medication within the eustachian tube and preventing it from flowing back into the nasopharynx. The patient remains mobile, and a long hospital stay is not required; regular medical monitoring is sufficient. An ear microscope can be used for monitoring.

After treatment, the ear catheter can be removed without difficulty after squeezing the sealing element.

An ear catheter can also be used to treat inner ear diseases, as medications can generally pass through the round window membrane into the inner ear. This is called diffusion.

Possible indications include, for example, intratympanic steroid administration for deafness, intratympanic steroid administration for hydropic ear disease (Ménière's disease), intratympanic gentamicin administration for hydropic ear disease, intratympanic contrast agent administration for suspected hydropic ear disease, intratympanic administration for gene therapy (CRISPR/Cas9), or intratympanic topical antibiotics. Use for other indications is at the discretion of the treating physician.

Possible substances that can be administered this way include, for example, dexamethasone, methylprednisolone, gentamicin, neomycin, growth factors, BDNF (brain-derived neurotrophic factor), neurotrophin-3, N-acetylcysteine, dextran, rhodamine, or gadolinium salt. Administration of other substances is at the discretion of the treating physician.

Preferably, the ear catheter is positioned using a special insertion device. The insertion device according to the invention, which is also suitable for use with an ear catheter, comprises three sections, namely a head section, a middle section, and an end section, each having a dividing line running longitudinally along at least some of the sections, such that the corresponding sections of the insertion device can be opened longitudinally.

The essential invention of this insertion device is, in other words, to provide an insertion device that is at least partially removable from the inserted catheter, wherein certain or all sections of the insertion device have one or more longitudinally extending dividing lines. These dividing lines extend through certain, several, or all sections of the insertion device. They can be continuous with one another, i.e., a single continuous dividing line across several or all sections is also possible, or the dividing lines can be provided differently in their position and implementation for each section.

The dividing line in the sense of the invention may be a thinning line in which the material of the insertion device at this location has a comparatively low strength.

Such a thinning line can be created, for example, by laser processing, but it is expediently created mechanically by means of cuts or perforation lines that facilitate tearing along this line.

Such cuts can, for example, extend across 40-70% of the insertion device's wall thickness in this area. In this case, separation occurs only under the user's influence.

However, the dividing line within the meaning of the invention may also represent an existing opening, where the material at the corresponding location is already completely divided, for example, during the composite manufacture of the corresponding part. In this case, the division is not performed solely by the user. Furthermore, the individual parts are connected by various connecting elements, which remain to be described.

The insertion device is essentially made of a rather rigid material, usually a polymer. Suitable polymers are known in medical technology, including thermoplastic plastics and thermoplastic elastomers, such as polyether block amides (Pebax). Some flexibility facilitates insertion, but too much flexibility means loss of guidance.

In the first preferred embodiment, the insertion device is designed for use with an ear catheter. The head portion of the insertion device is angled to facilitate easy insertion. The middle portion and end portion are substantially straight.

These three sections are of standard dimensions, for example, approximately 2.5 cm for the head section and approximately 14 cm for the middle section. The head section and middle section are inserted completely into the body through the patient's nose, while the end section remains outside the body. It is, for example, 15 cm long.

Naturally, the insertion device must be made of a material that can be incorporated into the body. Preferably, this material should be transparent.

The head section is generally bent at an angle relative to the stroke of the middle section, for example at an angle of 30° to 80°, in particular approximately 70°.

In this first embodiment of the insertion device, two dividing lines run along the length of both the head portion and the middle portion, allowing this portion of the insertion device to be torn apart. The end portion itself is split, forming two ends that can be grasped by the user to pull the insertion device out of the middle ear, eustachian tube, and nose with a catheter inserted. The dividing lines of the head portion and middle portion continue proximally along the dividing lines of both halves of the end portion, allowing the user to tear the entire insertion device apart by the free ends and remove it. The used insertion device is discarded.

It should be noted that "distal" in this context means the portion of the insertion device pointing toward the middle ear, while "proximal" means the portion pointing away from the middle ear.

It has been discovered that, in some cases, inserting an ear catheter using the insertion device according to the first embodiment can cause stress on the transition from the middle section to the end section, causing the dividing lines to break. To prevent premature rupture, it is advisable to provide the proximal end of the middle section with a safety element to prevent such a break. A suitable safety element is, for example, an adhesive tape ring that is torn off by the user before removing the insertion device. For this purpose, it conveniently has a free, non-adhesive end, which facilitates removal.

In practice, after inserting the catheter, the user grasps the two free ends of the insertion device, pulls the middle section and head section out of the patient's body, and then breaks the interconnected sections along the dividing lines, first at the middle section and then at the head section. This separates the insertion device from the catheter.

In a second preferred embodiment, the insertion device can also be used with an ear catheter. For this purpose, the head section, as described previously, can be angled to facilitate the insertion device's ease of placement in the eustachian tube. The middle section and end section are formed substantially straight.

The other considerations regarding the first embodiment regarding the dimensions of the input device and the preferred materials also apply here.

The second preferred embodiment differs from the first preferred embodiment primarily in the mechanism for separating the insertion device from the catheter. In the second embodiment, the insertion device is separated from the catheter, in particular, by opening the insertion device.

Accordingly, the input device according to this second embodiment is hinged and preferably consists of two parts, namely, it is divisible longitudinally into two halves. The dividing lines, as described previously, are provided here in the form of continuous slots. The two halves are preferably provided as mirror-image halves. However, it is also conceivable that the input device consist not of such mirror-image halves, but of their corresponding thirds or quarters, or other ratios. However, mirror-image symmetrical halves are preferred.

These halves are preferably permanently connected to each other at least in one place, so that they do not separate into two separate parts when swung open along the dividing lines. A suitable connecting element can be provided, for example, in the form of a hinge. Such a hinge is preferably provided in the region of the end section and connects the two halves. The hinge can be provided between the two halves during the manufacture of the operating device, for example by injection molding, or it can be connected to the two halves only after manufacture.

In embodiments that consist of several longitudinal parts, as described previously, other hinges are provided between the longitudinal parts.

Instead of hinges, other connecting elements may be used to connect the longitudinal sections of the insertion device. Such connecting elements do not necessarily need to create a permanent connection; it is sufficient if the individual longitudinal sections are securely held together during catheter placement.

A combination of hinges and other connecting elements is also practical. For example, a secure connection of the input device can be achieved using at least one hinge at the end, while other connecting elements can be provided for support at the middle and end sections, as well as at the head.

Other connecting elements may, for example, be locking or snap-in elements, the corresponding parts of which are located on the longitudinal parts to be joined. Thus, the other connecting elements are then preferably part of the input device.

However, other connecting elements are also conceivable, such as rings provided on the corresponding longitudinal sections of the entry device and capable of being separated to allow the entry device to swing open, for example, at designated locations where the intended destruction is expected. Other connecting elements may also be provided in the form of the previously described safety elements.

A second embodiment of the insertion device, with a non-destructive opening mechanism for essential components, can also be envisioned as a reusable product. Accordingly, particularly when designing the end section, a more robust structure can be achieved, enabling a particularly pleasant haptic experience for the user, for example, through the use of specially shaped gripping areas. Similarly, the end section can be provided with reusable connecting elements, for example in the form of bolts, which enable repeated opening and closing of the folded or, respectively, joined end section.

In one alternative embodiment of the second version, only the middle and end sections are designed to swing open. The head section, in contrast, is a single piece, tubular, and its proximal end can be connected to the distal end of the middle section via a coupling element.

This coupling element may be provided, for example, in the form of a thread. The head portion has an external or internal thread, respectively, and the middle portion has a corresponding mating portion. It is also possible for the coupling element to be provided as a separate structural component, namely, a threaded element into which the head and middle portions are screwed. Here, too, the arrangement of the mating external and internal threads is selected by a specialist according to each requirement. A preferred embodiment is one in which the head and middle portions have external threads, and this external thread (can) be screwed into the internal thread of the coupling element.

Other coupling elements can be imagined, for example in the form of, in particular, snap-on elements with force closure or locking elements.

The coupling element also serves as a connecting element, connecting the two parts of the middle part and the end part attached to it.

In an alternative second embodiment of the insertion device, the head portion, after removal of the middle and end portions, thus remains on the catheter and, after displacement towards the proximal end of the catheter, can be used, for example, as a fixation device to fix the proximal end of the catheter, for example, behind the ear of the patient.

This alternative second embodiment of the insertion device also offers the advantage of a replaceable head. A set could then include multiple head sections of varying angles with the main element of such an insertion device, namely the middle and end section assembly. The user can then select the head section best suited to the task from these different head sections. A wide variety of options are possible with respect to head section angles, head section lengths, and materials, which can be particularly stable or flexible.

Accordingly, such a set may also include head parts that are not necessarily related to ear treatment and are thus also suitable for use with other catheters.

Thus, the alternative second embodiment of the insertion device may also be provided as a combination product comprising a reusable main element together with replaceable and discardable head portions.

The second embodiment may alternatively include a tubular shell on the head and/or middle section, which fits snugly over these areas. This shell provides additional support to the two-part head and middle sections, while also firmly holding the two halves of these structural elements together. The shell may be one-piece or multiple-piece and installed at various locations on the head and/or middle section. The shell may also be provided solely as a ring, rather than as a long or solid tube.

A perforation line may be provided for opening and removing the casing. However, such perforation primarily serves for ease of maintenance. Without appropriate perforation, the casing can be removed by the user alternatively by longitudinal cutting or tearing. The casing material can be selected accordingly.

Since the sheath is inserted simultaneously during treatment, low-friction materials are particularly preferred. A specialist is familiar with a wide variety of materials, including various plastics, such as PTFE or ePTFE.

The invention relates, in particular, to the use of the insertion device described above for inserting an ear catheter. The invention also relates to a combination of an insertion device and an ear catheter, which are dimensionally matched. The ear catheter can be integrated into the insertion device, ready for insertion.

Although the invention has been described primarily in the context of ear catheters and their use in placing a catheter in the eustachian tube, the use of the insertion device proposed by the invention is by no means limited to such areas. Furthermore, the insertion device proposed by the invention is suitable for use in any application where, for the reasons described above, removal of the insertion device after successful placement is no longer possible without difficulty in the distal or proximal direction along the catheter.

The application possibilities and fields of application of the insertion device proposed by the invention are not limited to ear catheters in the nasopharynx. Furthermore, the insertion device proposed by the invention, particularly through the design of its individual sections, such as the head section, middle section, and end section, can be adapted to any intended use or, respectively, location of application.

For this purpose, these sections can, for example, vary in their dimensions, such as length and diameter, or their curvature, or certain, for example, more or less flexible materials are selected in accordance with the requirements of a specific place of application.

The invention, as well as the technical field, are explained in more detail below using the figures. It should be noted that the figures show a particularly preferred embodiment of the invention. However, the invention is not limited to the embodiment shown. In particular, the invention includes, where technically feasible, any combination of the technical features cited in the claims or in the description as relevant to the invention.

Shown:

Fig. 1: general view of the first preferred embodiment of the ear catheter according to the invention, having a screen as a sealing element;

Fig. 2: details of the proximal and distal portion of the preferred embodiment according to Fig. 1;

Fig. 3: other details of the distal portion of another preferred embodiment;

Fig. 4: different outlines of possible screen designs;

Fig. 5: different possibilities of connecting the proximal section of the screen to the catheter tube;

Fig. 6: overview of one of the preferred embodiments having a cylinder as a sealing element;

Fig. 7: details of the proximal end of the embodiment according to Fig. 6;

Fig. 8: other details of the proximal end of the embodiment according to Fig. 7;

Fig. 9: another detail of the proximal end of the embodiment according to Fig. 7 in one of the variants;

Fig. 10: first embodiment of the input device according to the invention;

Fig. 11: principle of use and removal of the first embodiment of the input device;

Fig. 12: the course of the dividing line of the first embodiment;

Fig. 13: a first embodiment of the input device according to the invention, having a burst fuse;

Fig. 14: a second embodiment of the insertion device according to the invention in an open state;

Fig. 15: a perspective view of one of the alternative design variants of the second embodiment of the input device proposed by the invention;

Fig. 16: a plan view of the inside of half of the insertion device according to Fig. 14;

Fig. 17: detailed views of Fig. 16;

Fig. 18: a perspective view in accordance with Fig. 6, including the shell;

Fig. 19: A detailed fragment of a perspective view in accordance with Fig. 18.

The ear catheter 1 according to the invention, according to Fig. 1, includes a catheter tube 3, at the distal end d of which a self-expanding screen 2 is provided. At the proximal end p of the catheter tube 3, there is a luer-lock connector 5 for a conventional syringe, by means of which the drug to be administered can be administered through the injection lumen 3A. The proximal end may also include an additional connector for a decompression lumen (not shown). The only lumen of the catheter 3 includes in this embodiment the injection lumen 3A, however, an embodiment is preferred in which the catheter, in addition to the injection lumen 3A, has another lumen for pressure relief, as shown in the following Fig. 3.

The ear catheter 1 has a total length of approximately 15 cm-30 cm with an outer diameter of the catheter tube 3 of preferably 2-3 mm and an inner diameter of the injection lumen of approximately 1 mm.

The expansion device 6 in the form of a tube, which is provided around the catheter tube 3 with a geometric or, respectively, frictional closure, serves to expand or, respectively, compress the screen 2. The expansion device 6, like the catheter tube, is preferably made of plastic.

At the proximal end p of the expansion device 6, a maintenance device 7 is provided which simplifies handling of the expansion device 6, since it allows for secure gripping and at the same time secure control of the expansion device 6.

The expansion device 6 serves to expand or, respectively, compress the screen 2. When the expansion device 6 in the distal d direction is displaced onto the screen and left there, then the screen 2 is in a compressed state, when the expansion device 6 in the proximal p direction is displaced downwards from the screen 2 and left there, then the screen 2 is in an expanded state.

In order to prevent unintentional expansion of the screen 2 due to sliding of the expansion device 6 during placement of the ear catheter 1 through the nose and the nasopharyngeal space, a spacer element may be provided between the luer lock 5 at the proximal end of the ear catheter 1 and the device 7 for servicing the expansion device 6, which may suitably be provided in the form of a slotted tube and thus can be pulled together and put back on (not shown).

Fig. 2 shows details of the distal end d and the proximal end of the ear catheter 1. A self-expanding shield 2 is provided at the distal end d of the ear catheter 1. This shield is preferably constructed of three sections 2A, B, C, namely, a distal section 2A having a large diameter, which extends cylindrically along a certain length without significant narrowing and which essentially represents a part of the shield 2 that creates a liquid-impermeable contact with the wall of the auditory tube. An optional proximal section 2C is provided in the form of a tube for securely fixing the shield 2 in the distal lumen of the catheter tube 3.

Therefore, the open diameter of catheter tube 3, which includes injection lumen 3A and decompression lumen (not shown), should only be slightly reduced so as not to interfere with fluid administration and pressure compensation. Between proximal section 2C and distal section 2A, a middle section 2B is provided, which is funnel- or cone-shaped, respectively, and expands from the smaller diameter of section 2C to the larger diameter of section 2A.

The structure of screen 2, i.e., the portion of the self-expanding support elements or, respectively, the frame, on one hand, and the membrane, on the other, can vary throughout sections 2A-C. Preferably, the membrane is manufactured as a single piece to ensure the best possible density and extends across all sections 2A-C.

To ensure the tightest possible seal between the shield 2 and the wall of the auditory tube, a cylindrical section 2A may be provided distally over a certain length. This section, in addition to the membrane, also includes a number of self-expanding support elements, which are preferably provided in the form of meandering ring segments and may be provided together as a frame or as individual support elements. However, the distal section 2A is optional; embodiments are also possible in which the distal end of the conical section 2B simultaneously forms the distal end of the shield 2.

Sections 2A-C may be supported, either partially or in whole, by self-expanding support elements or, respectively, by an interconnected framework. The structure and design may vary in individual sections 2A-C. For example, at the distal end d of shield 2, it is important to exert a sufficient, but not excessively high, radial force to ensure the tightest possible seal between shield 2 and the eustachian tube, while simultaneously avoiding pressure points and necrosis. The distal end of section 2B and/or the optional section 2A should be designed accordingly. Furthermore, conical section 2B should not have any corresponding radial forces, as it primarily serves to prevent the backflow of medication from the eustachian tube into the nasopharynx. Accordingly, section 2B, in the presence of distal section 2A, could, in principle, also be designed without a framework structure or corresponding supporting elements. The same applies to section 2C, which ultimately serves alone to fix the screen 2 in the catheter tube 3, which is also possible by means of only one connection between the membrane and the catheter tube 3.

Embodiments are possible in which the entire screen 2 is formed by an internal frame and/or corresponding support elements and a membrane connected thereto. A skilled person, without assistance from the inventor, will be able to find suitable combinations of screen sections 2A-C, which, in addition to the membrane, also include the frame and/or support elements, to suit each requirement.

The expansion device 6, which is provided in the form of a tube around the catheter tube 3, optionally includes a servicing device 7 at its proximal end, which facilitates the forward and backward displacement of the expansion device 6. In one preferred embodiment, a locking device 8 may be provided, by means of which the servicing device 7 can be removably connected to the luer-lock system 5, in order to prevent the displacement of the servicing device 7 when the screen 2 is expanded and, in particular, the compression of the screen 2.

The expansion device 6 is preferably provided in the form of a hose or, respectively, a tube. Embodiments are also possible in which the expansion device 6 is provided at least partially slotted, for example to increase the flexibility of the ear catheter 1.

The servicing device 7 can be provided in the form of a ring, and here, too, slotted embodiments or retaining elements only in certain places of the expansion device 6 are possible.

In order to prevent the backflow of the injected liquid through the injection lumen 3A, a one-way valve 4 is preferably provided at its distal end. A corresponding valve is provided for the decompression lumen (not shown).

During treatment, after inserting a catheter and dilating the screen, the medication is injected into the middle ear through 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 injected, the proximal portion of the insertion catheter is taped to the cheek. A sealing element remains in place in the eustachian tube to prevent the injected solution from escaping. At the end of treatment, the sealing element is compressed and the catheter is withdrawn.

In Fig. 3 another preferred embodiment of the ear catheter 1 is shown, having an injection lumen 3A and a decompression lumen 3B. The catheter tube 3 ends distally with an atraumatic tip 12, wherein the injection lumen 3A ends distally from the atraumatic tip 12 with an opening 3C, and the decompression lumen 3B ends proximally from the atraumatic tip 12 with an opening 3D. In contrast to the embodiment according to Fig. 2, at least a part of the catheter tube 3, including the injection lumen 3A and the decompression lumen 3B, is passed through the screen 2 and ends only distally from the screen 2.

In Fig. 4, images A-H show various possible designs of shield 2 in outline images, with the distal end always on the left and the proximal end on the right. These outlines correspond to each combination of a frame and membrane, meaning that the outline of shield 2 can be defined alternatively by essentially a frame, a membrane, or a combination of both.

Fig. 5 shows in detail various possibilities for connecting 9 the proximal section 2C of the shield and the catheter tube 3. Fig. 5A shows a connection 9 using locking elements 9A, which is preferably reinforced by injection molding. Fig. 5B shows an adhesive connection 9, in which the catheter tube 3 is pulled into the proximal end of the shield 2C and glued to it. For additional stabilization of the adhesive connection 9, the proximal end 2C of the shield may include stampings 9B.

Alternatively, this connection can also be realized as a pure geometric closure. Fig. 5C shows a connection 9 with a geometric closure with the optional help of additional retaining elements 9C, which increase the frictional resistance and thus additionally prevent the shield from slipping. In this embodiment, the catheter tube 3 surrounds the distal end 2C of the shield. This connection can also be additionally provided as an adhesive connection. Fig. 5B shows a screw connection 9 having a threaded connection 9D, wherein the external thread can be part of the distal end 2C of the shield, and the internal thread can be part of the catheter tube 3, or vice versa.

Fig. 6 shows a complete view of a preferred embodiment of an ear catheter 1 having a balloon as a sealing element 2. Three connectors are located at the proximal end of the catheter 3: connector 10C for inflating the balloon, connector 10A for connecting a syringe to the injection lumen, and connector 10B for compensating for pressure via a decompression connector. An atraumatic tip 12 is provided at the distal end of the catheter 1.

Fig. 7 shows a detailed view of the distal portion of the catheter together with the atraumatic tip 12, the balloon 2 lying proximally from it and three markers installed proximally in front of the balloon for endoscopic determination of the position of the ear catheter during placement.

Fig. 8 shows a detailed view of the first preferred embodiment of the distal portion of the catheter tube 3, wherein the injection lumen 3A ends at the distal apex of the atraumatic tip 12 with an opening 3C, and the decompression lumen 3B ends with a shift to the side at the atraumatic tip 12 with an opening 3D. The lumen 3E for inflation ends openly in the region of the balloon 2.

Fig. 9 shows another preferred embodiment of the distal portion of the catheter tube 3, wherein the decompression lumen 3B ends laterally distal to the balloon 2, but proximal to the tip (not shown) with an opening 3D. The lumen 3E for inflation ends in the region of the balloon 2 (the injection lumen is shown here).

Fig. 10 shows the insertion device 101 proposed by the invention, having a head portion 102 bent at an angle, a straight middle portion 103, and an end portion 104 split into two branches. The head portion 102 is bent at an angle relative to the middle portion 103, ideally at approximately 70° (shown differently). The angle of 70° is obtained relative to the stroke of the middle portion 103.

The end portion 104 is split into two branches, which serve as a means for the treating physician to separate the insertion device 101 along its length. The splitting of the middle portion 103 and end portion 102 continues along the length of the dividing line or seam 105, which is formed as a thinning zone, for example, by a partial incision.

Insertion device 101 is made of an integrable polymer with sufficient rigidity to provide the required guiding properties. However, this polymer must not exhibit excessive rupture resistance. Suitable polymers include standard polymers such as polyamide, polypropylene, or copolymers such as Pebax.

Fig. 11 is a sequence in which, in Figure A, an ear catheter 106 is shown inserted through the patient's nose using an insertion device 101 together with a connected pressure generator 107, in Figure B the removal of the insertion device 101 through the catheter tube from the patient's nose, in Figure C the insertion device 101 already completely removed from the patient's nose, in Figure D the insertion device 101 further torn, in Figure E the insertion device 101 torn to the distal head part 102 and in Figure F the completely torn insertion device 101, which is intended for disposal.

Fig. 12 shows the insertion device 101 according to the invention, which has a distal head portion 102, a middle portion 103 and two branches of an end portion 104, as well as a dividing line 105 drawn with a dashed line. This dividing line 105 continues along the entire length of the middle portion 103 and the end portion 104. It begins at the junction of the two branches of the end portion 104. Of course, there is a corresponding dividing line 105 on the opposite side.

Fig. 13 shows the proximal region of the inventive insertion device 101 having a safety element 108 at the proximal end of the middle part 103. This safety element 108 is an adhesive strip that surrounds the insertion device 101 at a designated location and prevents premature rupture along a dividing line 105. Before rupturing the insertion device 101, the adhesive strip 8 is torn off by the attending physician.

Fig. 14 shows a second embodiment of the insertion device according to the invention in an open state, having a first half A, including half of the head part 102', half of the middle part 103' and half of the end part 104', and also a second half B, including half of the head part 102, half of the middle part 103 and half of the end part 104. Halves A, B of the insertion device 101 in this example are formed mirror images of each other.

The head portion 102, 102' is bent at an angle relative to the middle portion 103, 103', when used as an insertion device for an ear catheter, preferably at approximately 70° (shown differently here). The angle of 70° is obtained relative to the course of the middle portion 103, 103'. In this case, an angle of 0° of the head portion 102, 102' relative to the middle portion 103, 103' would correspond in total to the straight course of the middle and head portions 103, 103', 102, 102'.

The halves A, B are connected to one another in the region of the end portion 104, 104', preferably in the gripping region 112, 112', by means of a connecting element 111. This connecting element 111 preferably permanently connects the two end portions 104, 104' or, respectively, the two portions of the gripping region 112, 112' to one another and is preferably already present during the production of the insertion device 101, but alternatively can also only later connect the portions 104, 104' or, respectively, 112, 112' or the two halves A, B, which were initially produced without interconnection, to one another.

At the end portion 104, 104', another connecting element 110A, 110B is also provided in the form of a locking lock, wherein the locking elements 110A, 110B mating with each other are each provided in corresponding places at the end portion 104, 104'.

A continuous channel extends through the insertion device 101, through which a catheter can be guided. This channel gradually widens at the proximal end of the end portion 104, 104' to facilitate insertion of a catheter (not shown) into the insertion device 101.

Fig. 15 shows a perspective view of one of the alternative design variants of the second embodiment of the insertion device 101 according to the invention. This alternative design variant differs only in the arrangement of the head part 102, which in the present case is not made of two parts, but is in the form of a non-detachable tube. The head part is connected by means of a coupling element 109 to a middle part 103, 103' consisting of two parts. The coupling part 109 is provided in the form of a cuff, which encircles the proximal part of the head part 102 and the distal part of the middle part 103, 103'. For connecting the head part 102, the coupling part 109 and the middle part 103, 103', for example, push-fit connections with a force lock or threads can be provided.

Thus, the coupling element 109 also serves simultaneously as an additional connecting element of the halves 103, 103' middle part.

The remaining elements of the input device 101, in particular the design of the end part 104, 104', having another connecting element'10, correspond to the second embodiment in accordance with Fig. 14.

Fig. 16 shows a longitudinal sectional view of the inside of half of the insertion device 101 according to Fig. 15. The individual elements correspond essentially to Fig. 14, to which reference is made accordingly. In contrast, this representation of an alternative design embodiment shows, in particular, the arrangement of the coupling element 109, which is provided here in the form of a cuff around the ends of the head and middle portions located one behind the other.

Fig. 17 shows technical details of certain portions of the alternative second embodiment according to Figs. 15 and 16.

Fig. 17A shows a longitudinal section through the distal end of the head portion.

Fig. 17B shows the coupling element 109 in longitudinal section together with the corresponding ends of the head part 102 and the middle part 103. The connection of these three elements is carried out by means of a thread, namely, an internal thread in the coupling element 109 and an external thread on the corresponding areas of the head part 102 and the middle part 103.

Fig. 17C finally shows a proximally widened region of the end portion 104 to facilitate insertion of a catheter (not shown) into the insertion device.

Fig. 18 shows a perspective view of an alternative structural variant of the second embodiment of the insertion device 101 according to the invention according to Fig. 15. In addition, this embodiment includes a shell 113, which is provided on the head and/or middle portion 102, 103 and fits tightly thereto. This shell 113 gives additional support to the two-part head and/or middle portions 102, 103 when it holds the two halves of these structural elements together.

Fig. 19 shows a fragment of casing 113 in detail. A perforation line 114 may be provided for opening and removing casing 113. However, such perforation primarily serves for ease of maintenance and may be omitted. Alternatively, the casing may be removed by the user by longitudinal cutting or tearing.

LIST OF REFERENCE DESIGNATIONS

1 Ear catheter

2 Screen (A: distal section; B: middle section; C: proximal section)

3 Catheter tube (A: injection lumen; B: decompression lumen; C: distal hole of injection lumen; D: distal hole of decompression lumen; E: inflation lumen; F: distal hole of inflation lumen)

4 One-way valve

5 Connecting device (Luer-lock system)

6 Expansion device

7 Maintenance device

8 Locking device

9 Connection

10 Proximal connectors (A: injection lumen; B: decompression lumen; C: inflation lumen)

11 Marker (A: first marker; B: second marker; C: third marker)

12 Atraumatic tip

101 Input device

102 Head part (102 first half; 102' second half)

103 Middle part (103 first half; 103' second half)

104 End part (104 first half; 104' second half)

105 Dividing line

106 Catheter

107 Pressure Generator

108 Safety element

109 Coupling element

110 Other connecting element (110A; 110B part of other connecting element)

111 Connecting element

112 Capture area (112 first part, 112' second part)

113 Shell

114 Perforation line d distally

p proximally.

Claims (10)

1. An ear catheter for insertion into the auditory tube, which has a first tube as a catheter tube (3), having at least one first lumen as an injection lumen (3A) for introducing liquid, at least one second lumen as a decompression lumen (3B) for releasing pressure and a self-expanding sealing element (2) for closing the auditory tube, characterized in that the sealing element (2) is provided at the distal end of the catheter tube (3) in the form of a screen and an expansion device (6) is provided to control the expansion of the screen (2), wherein the screen (2) includes self-expanding support elements and/or a self-expanding frame and a membrane fixed thereto. 2. An ear catheter according to claim 1, characterized in that these self-expanding support elements and/or this self-expanding frame are made of a material with shape memory. 3. An ear catheter according to claim 1 or 2, characterized in that the membrane is made of PTFE or ePTFE. 4. An ear catheter according to one of the preceding paragraphs, characterized in that the expansion device (6) is made in the form of a second tube having a distal and a proximal end, which is located with a geometric closure on the outside around the catheter tube (3) and is made with the possibility of longitudinal displacement relative to the catheter tube (3), and wherein the displacement of the expansion device (6) in the proximal direction releases the screen (2) for expansion, and the displacement in the distal direction compresses the screen (2). 5. An ear catheter according to one of the preceding claims, characterized in that the expansion device (6) at its proximal end includes a device (7) for maintenance. 6. An ear catheter according to one of the preceding paragraphs, characterized in that the catheter tube (3) has at least one connecting device (5) at its proximal end, in particular a luer-lock system (5). 7. An ear catheter according to claim 6, characterized in that the injection lumen (3A) and the decompression lumen (3B) extend proximally from the connecting device, approaching distally to the sealing element (2). 8. An ear catheter according to one of the previous paragraphs, characterized in that the distal end (12) of the ear catheter (1) is made atraumatic. 9. An ear catheter according to one of the preceding claims, characterized in that at least one one-way valve (4) is provided in one of the lumens of the catheter tube (3), in particular the injection lumen (3A) or the decompression lumen (3B). 10. An ear catheter according to one of the preceding claims, with an insertion device (101), characterized in that the insertion device (101) includes a head portion (102, 102'), a middle portion (103, 103') and an end portion (104, 104'), wherein the insertion device (101) consists of a biocompatible polymer, and at least one dividing line (105) passes through at least the middle portion (103, 103') and the end portion (104, 104'), respectively, along which the insertion device (101) opens or splits.