WO2019238921A1

WO2019238921A1 - Device for ventilating the middle ear

Info

Publication number: WO2019238921A1
Application number: PCT/EP2019/065674
Authority: WO
Inventors: Detlef Behrend; Mareike Warkentin; Robert Mlynski
Original assignee: Universität Rostock
Priority date: 2018-06-14
Filing date: 2019-06-14
Publication date: 2019-12-19
Also published as: DE102018114274B3; EP3806788A1

Abstract

The invention relates to a device for ventilating the middle ear. The present invention addresses the problem of meeting the following main requirements: - controlling biodegradation in accordance with the individual course of healing by matrix volume laser ablation; - targeted application of pharmaceuticals only at the site of action; and - good handling (insertion) in situ, particularly taking into account the best possible protection of the eardrum in the region of the insertion. The material in composite materials in which other constituents are embedded is referred to below as the matrix. The problem is solved by an eardrum implant for ventilating the middle ear. The eardrum implant for ventilating the middle ear has, according to different embodiments, an elongate hollow body, the elongate hollow body having a through-opening and two ends, the elongate hollow body being formed from a resorbable biomaterial, laser-scattering particles being introduced into the resorbable biomaterial. The eardrum implant is designed, according to different embodiments, such that, when laser radiation acts on the eardrum implant, the eardrum implant biodegrades in a targeted fashion as a result of the laser-scattering particles which are introduced into the resorbable material.

Description

Device for middle ear ventilation and aeration

description

The invention relates to a device for middle ear ventilation and ventilation.

The invention is in the field of medical technology and is used to ventilate and vent a middle ear.

Via the tube (tuba auditiva eustachii) the pressure equalization between the nasopharynx and the middle ear is realized.

Tube dysfunction often leads to timpani effusion, i.e. to a fluid accumulation behind the eardrum, which too

Otitis media and other complications, such as

for example, hearing loss. So-called tympanic tubes are used for therapy of tympanic effusions. However, there are problems with the use of these tubes.

A fundamental problem with the use of tympanic tubes is their uncontrollable loss followed by the frequency of complications from injuries in the removal of the tympanic tubes.

Economic aspects play a significant role in this. Timpaniomas occur in up to 80% of children from birth to school age, adults are affected less frequently. There is therefore an urgent need for development to increase success rates.

Usually, tympanic tubes made of metals such as gold and

Gold alloys or non-absorbable plastics such as PTFE, PE-LD and silicone elastomers. The latter are complex in the

Manufacture and require multiple molds

Parting planes and internal mandrel. [0006] Geometries of conventional timpani tubes vary. Basically they consist of a hollow cylinder, at the ends of which there is a flange. These flanges in turn can be of different types. There are specimens that have special tabs or notches that both pierce the eardrum

(Paracentesis), but should also facilitate removal of the tympanic tubes. Implants that are self-tapping are also common, making a paracentesis instrument unnecessary. This state of the art makes clear, among other things. the patent applications

GB 2 316 319 A, US 4 650 488 A, US 5 389 088 A, US 2005 0757 33 A.

The disclosure US 4 650 488 A discloses ventilation pipes

between the middle and outer ear made of biodegradable materials in connection with prosthetic devices.

[0008] PCT application WO 2008 079 476 A2 discloses a method for treating tissue in or around a eustachian tube of a patient's body by means of laser energy. Removal of material from a medical device by means of targeted control of biodegradation is not mentioned, but only in relation to the tissue.

US 6 589 286 B1 discloses a stent for placement in an Eustachian tube. Furthermore, the disclosed stent comprises a tubular body and flanges, which have a biodegradable polymer. Furthermore, stents are described in which at least one of the tubular bodies and flanges with at least one connection consisting of

Lubricants, antibacterial agents, anti-inflammatory agents, anti-fungal agents, drug carriers and anti-thrombogenic agents are afflicted.

[0010] Implants for the middle ear ventilation with the structural design according to the invention specifically designed therefor have not yet been disclosed. Removal of tympanic tubes by means of targeted control of a laser ablation has not previously been disclosed. As a laser ablation, too Laser evaporation refers to the removal of material from a surface by bombardment with pulsed laser radiation. Laser radiation with a high power density is used, which leads to rapid heating and the formation of a plasma on the surface of the material.

[0011] The publication US 2015 0057590 A1 discloses a self

inflowing implant, the purpose of which is to act as a pressure compensation tube in the eardrum, whereby it has the property that the tube can be detached with a specially formulated drop solution on command. This tube can be of various shapes and sizes, although the tube is typically a cylindrical tube with a hollow center that maintains a vent for the middle ear space. With this design, the ear tube promotes the drainage of middle ear fluid, allows air to penetrate into the middle ear and allows antibiotic drops to flow in.

Presentation of the invention

The object of the invention is therefore to eliminate the disadvantages of the prior art and to provide a device for middle ear ventilation and ventilation, which is easy to insert but also to remove.

The problem includes the task and goal of inserting and removing timpani tubes in their manageability and

Improve functionality. The aim of the embodiment according to the invention is to ensure reliable middle ear ventilation over the course of healing.

The present invention has for the task listed below

Main requirements to be met:

- Control of biodegradation according to the individual

Course of healing through matrix volume laser ablation

- Targeted application of pharmaceuticals only at the site of action and - Good handling (insertion) in situ with special attention to the best possible protection of the eardrum in the

Area of insertion. In the following, the material in is used as the matrix

Composite materials in which other components are embedded.

The object is achieved by an eardrum implant for middle ear ventilation and / or ventilation according to claim 1.

[0016] The eardrum implant for middle ear ventilation and / or ventilation has

According to various embodiments, an elongated hollow body, the elongated hollow body having a through opening and two ends, the elongated hollow body being formed from a resorbable biomaterial, wherein in the resorbable biomaterial

Laser scattering particles are introduced. According to various embodiments, the tympanic membrane implant is designed such that, by means of the laser scattering particles which are incorporated in the resorbable material, a targeted biodegradation of the tympanic membrane implant occurs when laser radiation acts on the tympanic membrane implant.

According to various embodiments, the laser scattering particles are silver nanoparticles, the silver nanoparticles preferably being one

Have diameters in the range of 5-80 nm. The silver nanoparticles particularly preferably have a diameter in the range from 10-20 nm. It is advantageous when using silver nanoparticles that, due to the biodegradation of the matrix, the silver nanoparticles are exposed on the surface and these then have an antibacterial effect. However, it is also conceivable that other laser scattering particles are incorporated in the resorbable material.

[0018] According to one embodiment, the laser scattering particles have a

Pharmaceutical foam wrap on. This enables targeted release of active ingredients directly at the site of action, namely on the eardrum and / or in

Middle ear, for example to prevent or fight inflammation and / or to accelerate a healing process. It is it is conceivable that the active ingredients are released in the time in which the implant is implanted in the eardrum, a short-term and / or long-term release of the active ingredient being conceivable. However, it is also conceivable that the active ingredients are not released until the matrix is irradiated as soon as the laser scattering particles are exposed on the surface.

Furthermore, the eardrum implant according to various

Embodiments a valve for preventing the penetration of liquids into the passage opening from the ear canal. The valve is preferably designed as a passive valve. Furthermore, the valve can have a hinge, preferably a film hinge.

[0020] According to one embodiment, the eardrum implant further has ventilation openings in the eardrum contact area.

Ventilation openings are holes in the eardrum implant in the area of the passage of the eardrum. These serve to ventilate the eardrum in the area of the passage opening at the points where the eardrum implant is in contact with the eardrum. A

Ventilation reduces the risk of necrosis. Necrosis is an uncoordinated cell death in which a cluster of cells dies. The causes of necrosis are in the eardrum contact area of the

Tympanic membrane implants can be, for example, oxygen deficiency, bacterial toxins and / or mechanical damage. The

Ventilation tubes prevent oxygen deficiency and promote an antibacterial climate between the eardrum and

Eardrum implant.

[0021] Furthermore, the elongated hollow body of the eardrum implant preferably has an elipsoidal cross section. The elipsoidal geometry ensures the protection of the radial connective tissue fibers of the

Eardrums during insertion. With the same area, the maximum elongation of the radial fibers is smaller than with a circular one Cross section which the majority of the known eardrum implants have.

According to various exemplary embodiments, the eardrum implant according to the invention is designed to be implanted in an eardrum. For this, the eardrum implant has at least one

Fasteners on. This at least one fastening means can be designed in the form of a flange which is arranged on at least one end of the elongate hollow body. Furthermore, that

Tympanic membrane elements have both a

Eardrum puncture (paracentesis), but should also facilitate removal of the tympanic tubes. Such elements can

for example in the form of special tabs or notches.

[0023] The invention has several advantages over the prior art. It eliminates the disadvantages of the prior art and provides an eardrum implant for middle ear ventilation and / or ventilation.

In addition to minimizing the injuries caused by surgery, which by means of the geometric design as an ellipsoidal cross section of the elongated hollow body, and the at least one

Fastening element, the possibility of atraumatic removal without mechanical manipulations by means of controlled laser ablation, which also affects the volume of material, is very important.

Implementation of the invention

The eardrum implant according to the invention is based on

Exemplary embodiments explained in more detail using drawings:

Show here

Figure 1 shows a longitudinal section of the invention

Tympanic implant in an implanted state Figure 2 shows a longitudinal section of an embodiment of the

eardrum implant according to the invention with fasteners

Figure 3 shows a longitudinal section of a further embodiment of the

eardrum implant according to the invention with

Ventilation openings

Figure 2 shows a longitudinal section of a further embodiment of the

eardrum implant according to the invention with a valve

Another sensible option is in addition to those previously used

circular cross sections also the use of ellipsoidal or polygonal cross sections. As bioabsorbable materials

thermoplastic starch, starch acetates, PDLA, PLLA, PDS, PGA or atactic PBH or blends made of them.

In the following description, reference is made to the accompanying drawings

Referenced in which to illustrate more specifically

Embodiments are shown in which the invention

Order can be exercised. In this regard, one

Directional terminology such as "top", "bottom", etc. used with reference to the orientation of the drawings described. The

Directional terminology is used for illustration and is in no way restrictive.

In Figure 1 is a longitudinal section of the invention

Tympanic implant shown. The eardrum implant for

Middle ear ventilation and / or middle ear ventilation has an elongated hollow body (1), the elongated hollow body (1) being one

Has through opening (2) in its longitudinal axis. The elongated hollow body (1) preferably has an ellipsoidal cross section.

The eardrum implant and / or the elongated hollow body (1) is / are formed from a resorbable biomaterial. According to the invention, the eardrum implant is designed such that laser scattering particles (8), which are incorporated in the resorbable biomaterial, provide targeted exposure to laser radiation on the eardrum implant

The eardrum implant is biodegraded. The laser scattering particles (8) are preferably silver nanoparticles. It is conceivable to use other laser scattering particles (8).

The silver nanoparticles preferably have a diameter in the range of 5-80 nm. The silver nanoparticles particularly preferably have a diameter in the range from 10-20 nm. This

However, diameter information is also available for other types of

Laser scattering particles (8) conceivable.

[0033] According to various embodiments, the

Laser scattering particles (8) have a pharmaceutical foam covering.

Figure 2 forms a longitudinal section according to an embodiment of the eardrum implant according to the invention similar to that

Tympanic membrane implant, which is shown in Figure 1, only with additional fasteners (3). The fastening means (3) are designed here in the form of flanges. It is also conceivable that a fastening means is arranged only at one end of the elongated hollow body (1). These are intended to prevent the eardrum implant from slipping and / or losing. The shape of these flanges can be different. The fastening means (3) can, however, also be designed in a different form. The presence of further fastening means (3) is also conceivable. For example, tabs and / or notches can be arranged on the eardrum implant and / or on the flanges.

[0035] Furthermore, as a non-limiting example, the arrangement of

Elements conceivable, which should facilitate both an eardrum puncture (paracentesis), but also a removal of the tympanic tubes. These elements are not shown in the figures. An embodiment of the eardrum implant is also possible, which is self-tapping and thus makes a paracentesis instrument unnecessary. Figure 3 forms a longitudinal section according to an embodiment of the eardrum implant according to the invention similar to that

Tympanic membrane implant, which is shown in Figure 2, only with additional ventilation openings (6). The arrangement of

However, ventilation openings (6) on the eardrum implant are also conceivable, differently than shown here, if the eardrum implant has no fastening means (3). The rear ventilation openings (6) are preferably in the eardrum contact area.

Figure 4 forms a longitudinal section according to an embodiment of the

inventive eardrum implant similar to that

The eardrum implant, which is shown in Figure 3, only with an additional valve (7). However, the arrangement of at least one valve (7) on the eardrum implant is also conceivable, differently than shown here, if the eardrum implant has no fastening means (3) and / or no ventilation openings (6). The at least one valve (7) prevents liquids from penetrating into the passage opening (2) from the auditory canal, so that a patient with an eardrum implant according to the invention can also go swimming or showering unhindered.

Preferably, the valve (7) is a passive valve, which is particularly

preferably has a hinge. The hinge can be designed, for example, in the form of a film hinge.

Since it is in the previous, described in detail

Tympanic implants are exemplary embodiments, they can be modified to a large extent in the customary manner by a person skilled in the art without departing from the scope of the invention. In particular, the concrete designs of the eardrum implants can also follow in a different form than that described here. Likewise, the eardrum implant can be designed in a different shape if this is necessary for reasons of space or design. Furthermore, the use of indefinite articles does not include "a" or "a" assumes that the characteristics in question can also exist more than once.

LIST OF REFERENCE NUMBERS

1 elongated hollow body

2 through opening

3 fasteners

4 eardrum

5 middle ear

6 rear ventilation opening

7 valve

8 laser scattering particles

Claims

Expectations

1. eardrum implant for middle ear ventilation and / or middle ear ventilation, eardrum implant having an elongated hollow body (1), the elongated hollow body (1) having a through opening (2) in its longitudinal axis, the elongated hollow body (1) being formed from a resorbable biomaterial, the eardrum implant being designed so that targeted laser biodegradation of the eardrum implant takes place by means of laser scattering particles (8) which are introduced into the resorbable biomaterial when laser radiation acts on the eardrum implant.

2. eardrum implant according to claim 1, characterized in that

the laser scattering particles (8) are silver nanoparticles.

3. eardrum implant according to claim 2, characterized in that

the silver nanoparticles have a diameter in the range of 5-80 nm.

4. eardrum implant according to claim 2, characterized in that

the silver nanoparticles have a diameter in the range of 10-20 nm.

5. eardrum implant according to claim 1, characterized in that

Laser scattering particles (8) have a pharmaceutical foam covering.

6. The eardrum implant of claim 1, further comprising

a valve (7) to prevent liquid from penetrating into the passage opening (2) from the ear canal.

7. eardrum implant according to claim 6, characterized in that

the valve (7) is a passive valve.

8. eardrum implant according to claim 7, characterized in that the valve (7) has a hinge.

9. eardrum implant according to claim 8, characterized in that the hinge is a film hinge.

10. The eardrum implant of claim 1, further comprising

Ventilation openings (6) in the eardrum contact area.

1 1. eardrum implant according to claim 1, characterized in that the elongated hollow body (1) has an elipsoid cross-section.

12. The eardrum implant of claim 1, further comprising

at least one fastening means (3).