Otoplasty for insertion into an ear canal and method for manufacturing an otoplast

Abstract

Otoplasty (2) for insertion into an ear canal (1.1) with - at least a first section (2.1) which can be arranged in an outer area of ​​the ear canal (1.1) and has an opening (2.1.1) with a cavity (2.1.2) extending along the ear canal (1.1), - at least a second section (2.2) which can be inserted into an inner area of ​​the ear canal (1.1) and - at least one tab (2.3) projecting outwards in the area of ​​the opening (2.1.1) of the first section (2.1), wherein - the tab (2.3) is flexible and extends substantially distally from the first section (2.1) at an angle (α) towards the opening (2.1.1), - a distal surface (2.1.3) of the first section (2.1) around the opening (2.1.1) lies substantially in one plane, - wherein the angle (α) of the tab (2.3) relative to the plane is 30° to 60°.

Description

[0001] The invention relates to an earmold for insertion into an ear canal according to the preamble of claim 1. The invention further relates to a method for manufacturing such an earmold.

[0002] From US patent 7,510,046 B2, an earplug is known which comprises a substantially hemispherical insertion part with an upper and a lower surface that face each other. Furthermore, the earplug comprises a handle part that is connected to the lower surface of the insertion part and extends rearward from it, a cavity behind the earplug above the handle, and a rear part that has a substantially hemispherical shape and projects slightly backward from the insertion part.The insertion part is configured to be partially inserted into the ear canal of a wearer, wherein the insertion part and the handle part are integrally formed from an elastically compressible material, and wherein the rear part and the cutting point of the rear part and the handle part are configured to receive and hold the tip of a finger of the wearer to facilitate partial insertion of the insertion part into the ear canal.

[0003] Furthermore, earplugs for insertion into an ear canal are known from EP 1 521 498 A2, US 2010 / 0307861 A1 and US 2 393 005 A.

[0004] The invention is based on the objective of providing an improved otoplasty compared to the prior art and an improved method for manufacturing such an otoplasty.

[0005] With regard to the otoplasty, the problem is solved according to the invention by the features specified in claim 1. With regard to the method for manufacturing an otoplasty, the problem is solved according to the invention by the features specified in claim 9.

[0006] Advantageous embodiments of the invention are the subject of the dependent claims. An earmold for insertion into an ear canal comprises at least a first section, which can be arranged in an outer region of the ear canal and has an opening with a cavity extending along the ear canal. Furthermore, the earmold comprises at least a second section, which can be inserted into an inner region of the ear canal and has at least one flap projecting outwards in the region of the opening of the first section, the flap being flexible. It is understood that the second section, when inserted, faces the eardrum. In particular, the earmold is a hearing protection earmold for noise reduction during sleep. Furthermore, such a hearing protection earmold can be used for noise reduction and simultaneous sealing against external influences in a workplace, for example, on a construction site.

[0007] The earmold according to the invention particularly improves the ease of removal while simultaneously providing a high level of wearing comfort. For this purpose, the flexible tab is designed as a handle for the user of the earmold. The tab is flexible enough that, for example, when the user is lying on their side or when wearing additional protective headgear, it is not perceived as a rigid part in the ear. When pressure is applied, the flexible tab easily bends towards the opening, i.e., towards the cavity of the earmold, and is therefore imperceptible to the user. In particular, a change in the position of the flexible tab, in which it protrudes inwards, does not affect the entire earmold. That is to say,The earmold is not pushed further and deeper into the ear canal when the flexible flap bends inwards, towards the opening and thus the ear canal. This prevents unpleasant pressure sensations and discomfort. Furthermore, wearing comfort, especially when lying down or sleeping, is increased because the flexible flap does not cause friction against the outer ear. Therefore, the person's sleep is not disturbed. This allows the person to assume any sleeping position with a high level of comfort. Furthermore, the flexible tab simplifies handling, particularly removal, of the earmold. The user can easily position their fingers on the flexible tab and pull the earmold out of the ear. For example, the flexible tab can be gripped between the thumb and forefinger. Due to its flexibility, the tab can be adjusted to a preferred pulling angle, making removal comfortable for the individual. Additionally, a person caring for a child can easily and simply remove the earmold from the child's ear canal.

[0008] In advanced otoplasty techniques, the surface of the flexible flap can be at least partially textured to increase grip.

[0009] According to a further development of otoplasty, the flap projects essentially distally from the first section at an angle towards the opening. This means that the flexible flap extends from the ear canal at a specific angle. This allows the bend to be precisely directed towards the opening. Furthermore, the angle makes the flexible flap easy to grasp. In particular, the angle minimizes pressure on the sections inserted into the ear canal, i.e., the earmold, when the flap presses inwards towards the opening. A distal surface of the first section around the opening lies essentially in a plane, with an angle of 30° to 60° relative to this plane.

[0010] A possible further development of the otoplasty involves shaping the flexible tab as a handle so that it rests against the tragus in the outer part of the ear canal. Specifically, the flexible tab is designed to bend towards the opening when external force is applied. For example, this bending can be initiated into the opening and / or at least partially into the cavity in the outer part of the ear canal due to pressure exerted by the tragus when the person is lying down. This bending movement is particularly natural and barely noticeable to the wearer.

[0011] According to a possible further development of the otoplasty, the opening and the cavity containing the flexible flap have corresponding dimensions. In particular, the flexible flap is smaller than the opening, allowing it to be easily positioned within the opening when force is applied and to easily return to its original position. In a further embodiment of the otoplasty, the flexible flap is completely enclosed within the cavity.

[0012] One possible design of the earmold involves the first section, the second section, and / or the flexible flap being at least partially made of a flexible material. For example, the earmold may be made entirely or partially of a flexible plastic, such as addition-curing silicone and / or two-component room-temperature curing silicone rubber, which is based, for example, on polydimethylsiloxane (PDMS). Alternatively or additionally, the earmold may be made entirely or partially of polyurethane. The hardness of the material depends on the type of earmold used. For example, a sleep earmold has a hardness of 25 Shore A, while hearing aid or hearing protection earmolds have a hardness of 40 to 70 Shore A.

[0013] Another possible design for earmolds involves incorporating at least one filter element in the first and / or second section for noise reduction and / or ventilation of the ear canal. For example, this filter element can be integrated into earmolds designed for use with helmets. The flexible flap bends towards the opening when the helmet is put on and worn, without the wearer experiencing any pressure changes or friction. The filter element can also be used for sound attenuation. The protective effect of the earmolds can be individually adjusted to a noisy environment using the filter element. For example, the second section, which is inserted into the inner part of the ear canal, has a recess extending along the ear canal in which the filter element is located.that the recess and / or filter element is connected to the cavity and extends towards the inner area of ​​the ear canal.

[0014] In a process for manufacturing an earmold, the earmold is produced entirely and in one piece from flexible material using a PNP process (short for: positive-negative-positive process) and / or a casting process, whereby the flexible flap is molded in the area of ​​the opening of the first section. The PNP process and / or the casting process is carried out according to the known state of the art. The first and second sections of the earmold together form the earpiece. Due to the one-piece manufacturing of the earmold, the number of manufacturing steps can be reduced. For example, the opening and the cavity do not need to be additionally shaped, and the flexible flap does not need to be mounted in a separate process step. Thus, in particular, assembly and manufacturing effort as well as assembly and material costs are reduced.For example, a digital / additive manufacturing process is used, employing techniques such as scan data modeling and stereolithography. One possible process is as follows: an ear impression is taken, followed by a scan impression; CAD / CAM modeling is created based on the impression data; a 3D printer is then used to produce a negative mold; the negative mold is filled with a flexible, for example, unvulcanized material; the material is polymerized; and after the flexible material has hardened, the earmold is finished.

[0015] Exemplary embodiments of the invention are explained in more detail below with reference to drawings.

[0016] It shows: Fig. 1 schematically an otoplast arranged in an ear, Fig. 2. Schematic perspective representation of otoplasty, Fig. Figures 3A to 3B schematically show a side view of the otoplasty with a flexible flap in different positions. Fig. 4 schematically a negative mold for shaping the otoplasty, Fig. 5 schematically depicts a process for manufacturing otoplasts and Fig. Figure 6 schematically shows a cross-sectional view of another embodiment of the otoplastic with a filter element.

[0017] Corresponding parts are marked with the same reference symbols in all figures.

[0018] Fig. Figure 1 shows an earmold 2 positioned in an ear 1. Specifically, the earmold 2 is a hearing protection earmold for noise reduction during sleep. Furthermore, such a hearing protection earmold can be used for noise reduction and simultaneous sealing against external influences in a workplace, for example, on a construction site.

[0019] To simplify the following description, the illustrations Fig. 1, Fig. 2, Fig. 3, Fig. 4 to Fig. Figure 5 shows a coordinate system, where the X-axis corresponds to the longitudinal dimension X of the otoplasty 2 and the Y-axis corresponds to the transverse dimension Y of the otoplasty 2. The otoplasty 2 is inserted along a length of the ear canal 1.1 of a person according to its longitudinal dimension X, and its transverse dimension Y corresponds to a diameter of the ear canal 1.1.

[0020] The otoplasty 2 is designed for insertion into an ear canal 1.1 or auditory canal. For this purpose, the otoplasty 2 comprises a first section 2.1, visible in the illustrated embodiment. The first section 2.1 is arranged in an outer region of the ear canal 1.1.

[0021] Furthermore, the otoplasty 2 includes a second section 2.2, which is inserted into an inner area of ​​the ear canal 1.1 and in Fig. 1 is therefore not visible.

[0022] Furthermore, the otoplasty 2 includes an outwardly projecting flap 2.3 in the area of ​​the first section 2.1. The flap 2.3 is designed to be particularly flexible. This flexible flap 2.3 is positioned directly on the tragus 1.2. The flexible flap 2.3 improves the ease of removal of the otoplasty 2 while simultaneously ensuring a high level of wearing comfort.

[0023] Fig. Figure 2 shows a perspective view of the otoplasty 2 in an uninserted state and in a starting position PA.

[0024] The first section 2.1 of the otoplasty 2 has an opening 2.1.1 with a cavity 2.1.2 extending along the ear canal. In particular, the first section 2.1 can be arranged in an outer region of the ear canal 1.1.

[0025] The second section 2.2 can be inserted into an inner region of the ear canal 1.1. In particular, the second section 2.2 has a different longitudinal orientation, at least in some sections, than the first section 2.1. The second section 2.2 follows the natural course of the ear canal 1.1 from the outer region to the inner region. The first section 2.1 is designed such that it sits firmly and completely within the outer region of the ear canal 1.1. In particular, the first section 2.1 has a larger diameter than the second section 2.2.

[0026] Furthermore, the earmold 2 includes the outwardly projecting flexible tab 2.3 in the area of ​​the opening 2.1.1 of the first section 2.1. For example, the flexible tab is designed as a handle for a person using the earmold 2, and the tab 2.3 is designed to be flexible in such a way that it is not perceived as a rigid part in the ear 1, for example, when the person is lying on their side or when additional protective headgear is worn. To remove the earmold 2, the person can easily position their fingers on the flexible tab 2.3 and pull the earmold 2 out of the ear 1.

[0027] In a further development process, to improve the grip of the flexible tab 2.3, a surface 2.3.1 of the flexible tab 2.3 can be at least partially provided with a structure not shown in detail. For example, the surface 2.3.1 can be studded, ribbed, corrugated and / or wavy.

[0028] The flap 2.3 is formed essentially distal to the first section 2.1, projecting at an angle α towards the opening 2.1.1. Distal refers to a position in which the flap 2.3 projects away from the ear canal 1.1 and thus outwards. A distal surface 2.1.3 of the first section 2.1 around the opening 2.1.1 lies essentially in a plane, with the angle α being between 30° and 60° relative to this plane. It should be noted that other angles α, for example from 15° to 80°, are also adjustable.

[0029] To increase wearing comfort in any sleeping or lying position when the otoplast 2 is in place, the flexible flap 2.3 is designed to bend towards the opening 2.1.1 when an external force is applied. An external force is understood to mean, for example, pressure applied to the flexible flap 2.3. For instance, the flexible flap 2.3 is pressed inwards, i.e., towards the opening 2.1.1, when the person assumes a side-lying or sleeping position or puts on earmuffs or a helmet. Specifically, the opening 2.1.1 and the cavity 2.1.2 containing the flexible flap 2.3 have dimensions corresponding to those of the earmold 2.3. Thus, depending on the force applied, the flexible flap 2.3 can be partially or completely accommodated in the opening 2.1.1 and / or in the cavity 2.1.2. This causes the flexible flap 2.3 to bend.3 not noticeable to the person and exerts hardly any pressure on an earpiece formed by the first and second sections 2.1, 2.2.

[0030] In the illustrated embodiment, the tab 2.3 has substantially smaller dimensions, such as length and width, than the opening 2.1.1. This allows the tab 2.3 to easily return to its initial position PA as soon as no further force is applied to it. In other words, the diameter of the opening 2.1.1 and the length of the cavity 2.1.2 are each substantially larger than the length and width of the flexible tab 2.3.

[0031] Furthermore, a bend towards the opening 2.1.1 and the cavity 2.1.2 is ensured by the flexible tab 2.3 resting against the tragus 1.2. Any force is initiated from the tragus 1.2. In addition, unpleasant friction on the ear 1 can be avoided.

[0032] In particular, the otoplasty 2 is made entirely of flexible material, such as silicone and / or polyurethane.

[0033] Fig. 3A and Fig. Figures 3B show the otoplasty 2 with the flexible flap 2.3 in different positions, whereby Fig. 3A shows the flexible tab 2.3 in a removal position P1 and Fig. 3B shows the flexible tab 2.3 in a force application position P2.

[0034] In the Fig. In the embodiment shown in Figure 3A, the flexible tab 2.3 is bent to the left from its original starting position PA, for example, to simplify the removal of the earmold 2. This makes handling easier for the person during removal. The person can easily position their fingers on the flexible tab 2.3 and pull the earmold 2 out of the ear 1, upwards in the illustrated example. The direction of movement B1 for removing the earmold 2 is shown in Fig. 3A is marked with an upward-pointing arrow. For example, the flexible tab 2.3, especially as a grip tab, can be grasped between the thumb and forefinger. Furthermore, the forefinger or thumb can easily be partially inserted into the opening 2.1.1 from above to lift or push the tab 2.3 to the left. Due to the flexibility of the tab 2.3, it can be held at a preferred pulling angle, making removal comfortable for the individual.

[0035] In the Fig. In the embodiment shown in Figure 3B, the flexible tab 2.3 is arranged in the area of ​​the opening 2.1.1 and is thus pressed downwards from its initial position PA towards the opening 2.1.1 and the cavity 2.1.2. An outwardly facing surface 2.3.1 is flush with the distal surface 2.1.3 of the opening 2.1.1. The direction of movement B2 when force is applied to the flexible tab 2.3 is shown in Fig. 3B is marked with a downward-pointing arrow. The bending is not perceptible to the person when force is applied. In particular, a change in the position of the flexible flap 2.3, in which it protrudes inwards towards the cavity 2.1.2, i.e., downwards in the illustrated embodiment, does not affect the entire earmold 2. That is, the earmold 2 is not pushed further and deeper into the ear canal 1.1 if the flexible flap 2.3 can be pressed into the opening 2.1.1. This prevents unpleasant pressure sensations and discomfort.

[0036] Fig. Figure 4 shows a negative mold 3 for shaping and manufacturing the otoplasty 2 with the flexible tab 2.3.

[0037] The negative mold 3 can be constructed, for example, using a so-called rapid prototyping process, whereby the negative mold 3 was previously modeled, for example, from a scanned impression of at least one ear canal 1.1 of a person using a suitable computer program. The negative mold 3 is then filled with suitable, for example, otoplastic silicones. For this purpose, the negative mold 3 thus comprises an empty interior space 3.1, which can be filled by means of conduit elements 3.2 formed in the negative mold 3.

[0038] For the simultaneous forming of the flexible tab 2.3, the negative form 3 includes, for example, an additional forming element 3.3, which corresponds to the shape of the tab 2.3 to be manufactured in negative form.

[0039] Fig. Figure 5 shows a process for manufacturing the otoplasty 2 according to the Fig. 1, Fig. 2, Fig. 3 to Fig. 4.

[0040] For example, otoplasty 2 is produced using a so-called PNP procedure and / or preferably using a casting procedure. At least one of these procedures can be carried out as follows:

[0041] A digital 3D graphic is generated from an impression, particularly a silicone impression, of an ear canal 1.1 using a 3D scanner. Subsequently, a digital and three-dimensional negative mold 3 is modeled from the scanned data of the impression. The flexible flap 2.3 to be formed is also modeled in the area of ​​the opening 2.1.1 using the negative mold 3. The build process in the additive casting technique usually takes place using stereolithography or the so-called DLP process. For example, the negative mold 3 is produced using a 3D printing process. After completion of the negative mold 3, the interior 3.1 is filled with, for example, two-component room-temperature curing silicone rubbers (RTV-2) based on polydimethylsiloxane (PDMS). After the silicone rubber has completely hardened, the negative mold 3 is broken, thus revealing a silicone blank 4, which will later be the otoplasty 2.After removing any excess material (4.1) from the silicone blank (4), the earmold (2) can be painted to create a completely smooth surface. The earmold (2) can then be further processed according to its intended use.

[0042] Fig. Figure 6 shows a sectional view of another embodiment of the otoplasty 2 with a filter element 2.4. The in Fig. The otoplastic shown in 6 is, for example, a hearing protection otoplastic for sound insulation.

[0043] In the illustrated embodiment, the filter element 2.4 is arranged in the second section 2.2 of the earmold 2. The filter element 2.4 is designed to filter noise and / or ventilate the ear canal 1.1 in the second section 2.2. For example, the filter element 2.4 can be integrated into hearing protection earmolds designed for use with helmets. The flexible flap 2.3 bends towards the opening 2.1.1 when the helmet is put on and worn, without the wearer experiencing any change in pressure or unpleasant friction. The protective effect of the hearing protection earmold can be individually adjusted to a noisy environment by means of the filter element 2.4. For example, the second section 2.2 has a recess 2.2.1 extending along the ear canal 1.1, in which the filter element 2.4 is arranged. That is, the recess 2.2.1 and / or the filter element 2.4 with the cavity 2.1.2 is connected and extends towards the inner area of ​​the ear canal 1.1. REFERENCE MARK LIST 1 ear 1.1 Ear canal 1.2 Tragus 2 Otoplasty Section 2.1 2.1.1 Opening 2.1.2 Cavity 2.1.3 distal surface 2.2 second section 2.2.1 Recess 2.3 Tab 2.3.1 Surface 2.4 Filter element 3 negative form 3.1 Interior 3.2 Conductor element 3.3 Shaping element 4 silicone blanks 4.1 Overhang B1, B2 Direction of movement PA Starting position P1 Pickup position P2 Force application position α angle X, Y axis

Claims

[1] Otoplasty (2) for insertion into an ear canal (1.1) with - at least a first section (2.1) which can be arranged in an outer area of ​​the ear canal (1.1) and has an opening (2.1.1) with a cavity (2.1.2) extending along the ear canal (1.1), - at least a second section (2.2) which can be inserted into an inner area of ​​the ear canal (1.1) and - at least one tab (2.3) projecting outwards in the area of ​​the opening (2.1.1) of the first section (2.1), wherein - the tab (2.3) is flexible and extends substantially distally from the first section (2.1) at an angle (α) towards the opening (2.1.1), - a distal surface (2.1.3) of the first section (2.1) around the opening (2.1.1) lies substantially in one plane, - wherein the angle (α) of the tab (2.3) relative to the plane is 30° to 60°. [2] Otoplasty (2) according to claim 1, wherein the flexible tab (2.3) is designed as a handle part such that it rests against the tragus (1.2) in the outer region of the ear canal (1.1). [3] Otoplasty (2) according to claim 1 or 2, wherein the flexible tab (2.3) is designed such that it bends towards the opening (2.1.1) when an external force is applied. [4] Otoplasty (2) according to one of the preceding claims, wherein the opening (2.1.1) and the cavity (2.1.2) have dimensions corresponding to the flexible tab (2.3). [5] Otoplasty (2) according to one of the preceding claims, wherein the flexible tab (2.3) is fully receptible in the cavity (2.1.2). [6] Otoplasty (2) according to one of the preceding claims, wherein the first section (2.1), the second section (2.2) and / or the flexible tab (2.3) are at least partially made of flexible material. [7] Otoplasty (2) according to one of the preceding claims, wherein at least one filter element (2.4) is arranged in the first and / or second section (2.1, 2.2). [8] Otoplasty (2) according to claim 7, wherein the filter element (2.4) is connected to the cavity (2.1.2) and extends towards the inner region of the ear canal (1.1). [9] Method for manufacturing an otoplast (2) according to one of the preceding claims, wherein the otoplast (2) is manufactured completely and in one piece from flexible material using a PNP process and / or a casting process, wherein the flexible flap (2.3) is formed in the area of ​​the opening (2.1.1) of the first section (2.1) at an angle (α) of 30° to 60° in the direction of the opening (2.1.1).

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