DE102006007032A1 - Ear insert, e.g. hearing aid or miniature loudspeaker, adapted to individual outer ear contours, is obtained using digitalized geometry of hardened molding of outer ear region in impression material - Google Patents

Abstract

Production of an ear insert (1), individually adapted to the outer ear contours, involves molding the outer ear region in a plastically kneadable, non-flowable, hardenable impression material; hardening; evaluating the geometry of the obtained shaped piece (2) using a scanner; designing a digital ear insert geometry based on the evaluated geometry; and producing the insert based on the digital geometry, using a 3-dimensional, computer-controlled method. Production of an ear insert (1), individually adapted to the contours of the outer ear region bordering the exterior of the auditory channel, involves: (A) providing a plastically kneadable, non-flowable (or only slightly flowable), hardenable impression material (A); (B) molding the outer ear region with (A), without allowing (A) to pass via the entrance region into the auditory channel; (C) hardening (A) to a shaped piece (2); (D) extracting the shaped piece; (E) evaluating the geometry of the piece using a scanning device (preferably a 3-dimensional scanner); (F) designing a digital ear insert geometry based on the evaluated geometry; and (G) producing the insert based on the digital geometry, using a 3-dimensional, computer-controlled method. Independent claims are included for: (1) an ear insert (1) obtained by the process; (2) an ear insert arrangement (3), comprising an insert (1) as above plus an adapter chamber permanently bonded to an adapter piece, where the insert and adapter piece have complementary surfaces and the adapter piece has a connecting region for coupling an acoustic signal transfer device (5); (3) a variant of the ear insert arrangement (3), comprising an insert (not necessarily as above) with a connecting region for coupling an acoustic signal transfer device, where an ear-side sound opening is included, having dimensions corresponding to a corresponding sound opening in the signal transfer device; and (4) the use of either form of the ear insert, where the cavity of the insert is completely filled in or filled with sound insulating material, for hearing protection.

Description

The The present invention relates to a process for producing a Ohreinsatzes, which individually to the relief of an outside of the Auditory canal adjacent Adapted to the auricle region is. The invention also relates to an ear insert, an ear insert assembly and the use of an ear insert assembly.

To Ear inserts produced by such a method may serve to provide an earphone, a Miniature speaker or similar record, so accurate can be used in the corresponding auricle.

Such a method and such an ear insert is for example from the DE 101 11 636 B4 known. The correspondingly prepared recording is used to record an earphone, or a so-called headset, which is so comfortable and safe to wear in or on the ear.

From the DE 40 41 105 A1 is a method for producing an individually adapted to the contours of an ear canal Otoplastik or Ohrpaßstücks known. In this case, a method is described in which the contours of the ear canal are detected, for example by means of an ear canal impression, and then converted into a three-dimensional computer model which serves, computer-aided, to produce a corresponding ear tip for recording in the ear canal. Such earmolds are intended to receive hearing aid components for hearing aids.

at both methods is for the direct detection of ear relief or auditory canal geometry via a Impression method a comparatively complicated ear impression required, the high demands on the craftsmanship in the preparation and execution to the hygienic conditions. For taking impressions it namely required that the Ear canal or ear canal closed with a suitable plug before taking the impression is going to be reliable to prevent impression material too far into the ear canal penetrates. This comparatively invasive procedure requires practiced and trained staff and can - already for hygienic reasons alone - not everywhere. There is also a certain risk of injury and infection. Usually to lead only trained hearing care professional or appropriately trained medical personnel such Molding process.

That in the DE 101 11 634 B4 described method also requires a relatively high manual effort in the production of the fitting piece, since the actual ear insert is produced in a complex manual casting and processing method according to the molded article formed from the molding material.

The Object of the present invention is to provide an improved To provide a method which comprises at least part of the above cleared out the disadvantages so that appropriate ear tips cost also for applications can be produced in consumer electronics and entertainment and also for Hearing protection applications are suitable.

These The object is achieved by a method according to claim 1.

there is used to make the desired auricle area a plastically deformable (kneadable), not or only slightly flowable, curable impression material used, which allows the Shape the auricle so that without further action It can be ensured that the Impression mass not unintentionally over penetrates the entrance area into the ear canal or the ear canal. This measure It allows the impression taking virtually anywhere even by comparatively perform untrained persons to let and simplifies the impression taking considerably. It is even possible, in this way make the impression itself on your own ear.

Farther is after the impression material has cured to a molding and is removed, the fitting geometry by means of a scanning device, in particular a 3D scanner, detected. On the basis of this molding geometry a digital ear insert geometry is designed. Inaccuracies, the at the ear impression possibly have arisen, balanced without elaborate manual post-processing become. The production of the ear piece based on the digital Ear insert geometry using a three-dimensional, computer-controlled Manufacturing process allows a repeatable, crafted Skills independent, inexpensive Production of such ear pieces.

Since the Ohrgeometriedaten exist in digital form, the production of the ear insert after the detection of the molding geometry (scanning) can be done completely independent of a physical model. Overall, the inventive combination of the individual process steps allows a substantial decoupling of the decrease of the ear impression and the detection of the fitting geometry of the further design of the Ehreinsatzgeometrie and the production of the actual Ehreinsatzes. Both the geometry of the mold after digitization and the resulting one designed actual ear insert geometry is available in digital form. Thus, processing steps can readily be performed at spatially distant locations, without the risk that qualitative losses on the actual ear insert occur.

The Further development of the method according to claims 2 and 3 relates to a suitable impression mass, with which the desired impression taking is feasible.

claim 4 relates to an embodiment of the method, in which an additional Membrane is used, which is the actual molding artisanal relieved - especially the molding of cured to a molding impression material from the Auricle area - and make sure the sensitive ear canal is protected during molding against the molding material without a foreign body - Wattepfropfen or similar - introduced into the ear canal and again would have to be removed. simultaneously is prevented with such a membrane that the impression material during modeling detected in the auricle possibly existing hair, so that the removal definitely painless. The membrane also serves as an infection barrier against the transmission of germs in the ear and from the ear to the impression mass and thus on the fitting. It is removable after taking the impression of the fitting.

According to claim 5, the design of the digital ear insert geometry is done in two Steps: The design of the auricle geometry, in the areas, The later on the finished ear insert in contact with the correspondingly complementarily formed ear portions stand. In this design can with suitable CAD machining tools also irregularities the fitting geometry be compensated. The design of the free outer surfaces can independently be made of it and be optimized so that appropriate attachment or built-in devices optimally aligned aligned on or in the ear insert.

In the development according to the claim 6, the auricle geometry becomes larger or smaller than that of the auricle Auricle relief are designed. This can on the one hand against the actual auricle geometry possibly occurring volume shrinkage of the fitting are taken into account and to others considered special manufacturing aspects in the production of the ear insert become.

It but it is also possible through this change the auricular geometry to achieve special application effects, so that too the actual ear insert with a corresponding excess or one Undersize made becomes. So it is e.g. when using the ear insert with a earphones or a so-called headset may be desirable, the Ehreinsatz with an undersize, so that the Ear insert relatively loose and therefore pleasant for a long time to wear in the ear can remain. At the same time as a ventilation of the Ear interior done without additional ventilation holes or channels required are. The earmuff serves but also at the same time as hearing protection, or to, ambient noise shield, that's an execution with oversize, i. a tight fit in the pinna, may be desirable.

According to claim 7, the method is further developed in that in the (digital) ear insert geometry one or more cavities are arranged, which serve as a sound and / or ventilation duct, as a receiving space for the Earphones or the headset itself or for suitable adapters with a connection geometry for too coupling devices, and for Components for power supply, for a speaker device, a microphone device, an amplifier device, for controls or similar. These cavities can on CAD model of ear insert geometry too considering be arranged particularly easily by collision conditions.

In Claim 8 are exemplary suitable three-dimensional, computer-aided manufacturing process indicated, such as stereolithography, computer-controlled milling or Grinding, 3D printing, etc. These procedures can also combined or executed in succession. For example can the outer geometry, and in particular the auricle geometry in a stereolithography method or a 3D printing process are established, and then appropriate cavities with mechanical (milling, grinding, Drilling) procedures are introduced.

Claim 9 relates to an ear insert, which is produced by a method according to the invention. Claim 10 an ear insert assembly having such an ear insert, wherein this has an adapter cavity. About such an adapter cavity, in which a corresponding adapter piece is fixedly arranged, it is possible to arrange devices for transmitting acoustic signals with different interface geometries on or in the ear insert, without this interface geometry must be individually formed in the corresponding ear insert. Thus, for example, several uniform ear inserts can be produced (also in stock), which can then be coupled via a corresponding adapter piece with different devices for the transmission of acoustic signals. In this way, ear pieces with individual Auricular geometry and a unitary adapter cavity are made, which can then be coupled via a corresponding adapter piece with different devices. In this way, the individually required geometry of the ear insert can be limited to the actual auricle region.

According to claim 11, an ear insert assembly is provided, the apparatus for transmission acoustic signals all the necessary components for sound and signal transmission or contributes to the energy supply. According to claim 12 is such a device as a headset with loudspeaker arrangement and / or a microphone arrangement Mistake.

claim Figure 13 relates to an ear insert assembly which is especially for use with commercial earphones or headsets is executed. Here is a very big one Sound outlet provided, the about an existing sound outlet opening such a headset or earphone equivalent. In this way, the acoustic properties available Devices little or not at all affected, so that such Devices without further be used with a matched to the ear geometry ear insert can.

According to claim 14, an ear insert assembly is shown in which the ear insert geometry smaller than the original one molded auricular relief is formed and so special high wearing comfort is achievable. Here is an undersize of 0.45 to 3 mm and in particular a range of 0.2 to 1 or 0.1 to 0.5 mm provided. As under- or oversize here is the distance between the original one surface of the auricular relief and a proportionately shrunken or extended corresponding outer surface of the Ear insert referred. With respect to spherical surfaces, the same or excess of the distance between the surfaces two different sizes, concentric nested spheres.

According to claim 15, an ear insert assembly is provided in which the ear insert geometry formed with a corresponding excess is. In this way, the ear insert sits particularly firm or special tight in the pinna and it is a safe whereabouts of the ear insert assembly in the ear even with violent head movements possible. At the same time Ambient noise better shielded. According to claim 16, a cavity of the ear insert is completely filled. This is a use a corresponding Ehreinsatzanordnung also as hearing protection possible. Execution according to claim 17 improves the properties for this application. Claim 18 relates to the use of such an ear insert assembly as hearing protection even.

One embodiment The present invention will now be described by way of example with reference to the figures, in to those

1 represents the sequence of a method according to the invention for producing an ear insert,

2 FIG. 11 shows an external view of an earmold assembly (which is disposed in an ear and coupled to an earphone);

3 a longitudinal section through the in 2 illustrated ear insert assembly shows

3a shows a longitudinal section through an alternative ear insert assembly,

4 shows an ear insert with an adapter cavity and an adapter piece disposed therein,

5 an ear insert assembly which is suitable as ear protection shows, and

6 a representation to explain the terms under or oversize is.

1 shows an embodiment of the method according to the invention for the production of an ear insert 1 , In the process, customer data is first recorded for which the ear insert 1 is provided. Subsequently, the relief of an outer ear canal adjacent to the ear canal is molded. This is done with a plastically deformable, curable impression material, which is prepared for example from two components of an addition-crosslinking silicone material by mixing the two components. Subsequently, the desired auricle region is molded with the impression material, without the impression material penetrating beyond the entry region into the ear canal or the auditory canal. For this purpose, the impression mass in the ready-to-use state has a corresponding viscosity and can be processed within a period of up to 10 minutes. There are also impression materials in which, after mixing, the processing time is only 1-5 min. When molding the impression material is pressed into the auricle. It is molded by molding on the anthelix, the tragus and the antitragus of the auricle of the Concha area (Cavum Conchae, Cymba Conchae). The consistency of the impression mass prevents it from penetrating beyond the entrance area into the ear canal itself. After molding the impression material into the auricle, it hardens within 10 minutes to form a fitting 2 out. The cured fitting has a Shore A hardness of 15 to 95 on. This elasticity allows easy removal of the fitting 2 from the auricle. In a varied procedure, a thin, flexible membrane is placed over the auricle before modeling the impression material, which conforms flexibly to the auricle relief during molding. This membrane also prevents the impression material from penetrating the ear canal. At the same time it causes a uniform rounded shape of the impression material in the area in which this protrudes a piece into the entrance area of the ear canal. The membrane also acts as a barrier to the penetration of germs into the ear canal during molding and, on the other hand, prevents germs or pathogens from adhering to the fitting 2 be transferred from the ear. Finally, it is also prevented by the use of the membrane that the impression material optionally forms existing hair in the entrance area of the ear canal and pulls out during molding. As a membrane, for example, suitable plastic films in question, which can be easily removed after molding from the fitting and cling to the auricle relief.

The next step is the fitting 2 trained auricle geometry using a 3D scanner detected and digitized digi. This purpose, for example, a scanner that detects the surface geometry digital.

The detected fitting geometry serves as the basis for designing a digital ear insert geometry using a CAD program. When designing or modeling the digital ear insert geometry, discernible inaccuracies and molding defects of the molding can be identified 2 Getting corrected. In this modeling process, the exposed outwardly facing surfaces of the ear insert geometry as well as the intended sound channels and receiving areas for components will also be provided. These cavities and in particular sound transmission channels can be made sound optimized.

The thus generated ear insert geometry serves to control a three-dimensional, computer controlled manufacturing process.

These serve in a next step to one or more ear pieces 1 to customize. Suitable methods are, for example, laser polymerization methods, computer-controlled milling, drilling or grinding methods, 3D printing methods and other suitable additive or subtractive production methods with which three-dimensional bodies with undercuts of suitable materials and with sufficient accuracy can be produced. It is also possible to use suitable casting methods (for example injection molding, vacuum casting). In the in 1 The methods shown follow the actual production of the insert still post-processing steps in which other components can be combined with the ear insert. These post-processing steps may also be surface treatments (grinding, polishing or coating processes (painting or the like).

The 2 - 5 relate to ear inserts or ear insert assemblies that can be produced by means of the method according to the invention. 2 shows an ear insert assembly 3 in the ear 4 is used. The ear insert assembly has an ear insert 1 on, which is prepared by the method described above. In the Ohreinsatz is a device for transmitting acoustic signals 5 used. In the illustrated embodiment, this is a so-called earphone, via a cable 6 is connected to a signal source (not shown). This may be a telephone, a music player, a radio, a communication system or the like. The in 3 shown section AB shows that the earphone 5 in a cavity 7 is inserted, over the sound channel 8th , which opens into the ear canal with inserted ear insert and the earphone 5 in the cavity 7 given acoustic signals in the ear canal. In other embodiments, in the cavity 7 Another device, such as a so-called headset - a microphone-speaker combination - are used. In other embodiments, the signal transmission can also be wireless, eg via Bluetooth or other radio protocols. In other (not shown) embodiments of the fitting 2 can also be provided more cavities or channels, eg for Ohrbe- or venting. The remaining cavities may include components such as speakers, microphones, power supplies, receiving antennas, transmitting antennas, signal terminals, and other components. The arrows K indicate undercuts on the ear insert 1 or on the outer geometry facing the ear, with which the ear insert is securely fastened to corresponding complementarily shaped regions of the auricle.

4 shows an ear insert assembly 3 , at the earmuff 1 an adapter piece 9 attached, which has a receiving area 10 comprising, for coupling a in 4 not shown device for transmitting acoustic signals is used. For coupling the adapter piece 9 to the earmuff 1 these have a respective complementarily formed area 11 on, on which the adapter piece can be connected to the ear insert (glued, screwed, snap connection). Through the adapter piece 9 is it possible to use the cavity area 7 on ear inserts 1 consistent with individual "ear" geometry, and across different ad apterstücke 9 with different connection areas 10 to establish a connection to various devices for the transmission of acoustic signals. This standardization of the cavity area simplifies the method, in particular in the design of the inner geometry of the ear insert.

5 shows an ear insert assembly 3 ' based on an ear insert 1 is formed, and in which the cavity 7 to the outside with a lid 11 ' is closed and the remaining cavity area with a sound-absorbing material (eg silicone, plastic foam, etc.) is filled. In a non-illustrated embodiment, the ear insert can also be completely without a cavity 7 or sound channel 8th be formed and made even of a sound-absorbing or sound-absorbing material. Such an ear piece 1 can then be used as ear protection to shield against ambient noise and environmental noise.

In order to improve this effect, the geometry facing the auricle can also be produced with an excess, by making the ear insert slightly larger than the shaped auricle relief on the ear-shell side. This excess can already be realized in the design of the ear insert geometry. 6 shows how the term excess is to be understood in this context. In sub-figure a represents the dashed line 12 the contour of the relief of an auricle region. The line 13 represents the complementary contour of the ear insert 1 which is made with a so-called oversize A. In practice, this means that the auricle is to a certain extent "too small" for the correspondingly produced ear insert. As a result, the earmould sits snugly in the auricular relief and shields the ear canal effectively against noises. The oversize is in a range of 0.45-3 mm, or 0.2-1 mm or 0.1-0.5 mm.

6b shows the opposite case, in which the ear insert geometry (contour 13 ' ) with an undersize b in comparison to the actual auricle geometry (contour 12 ) was made. This embodiment has advantages in an ear insert assembly with a device for transmitting acoustic signals. For one, the earmuff sits 1 slightly looser in the outer ear, which can improve the wearing comfort, but is still in the areas K ( 3 . 4 and 5 ) held securely and positively in the ear. At the same time, the somewhat "too small" design of the ear insert allows ventilation of the ear canal when the ear insert assembly is inserted, without the need for additional ventilation channels. Finally, in addition to the device for transmitting acoustic signals and ambient noise can be perceived, which can be useful for example in road traffic. The undersize is in a range of 0.45 to 2 mm, from 0.2 to 1 mm or from 0.1 to 0.5 mm.

In 3a an alternative ear insert assembly is shown. This embodiment is specially adapted to the requirements for use with available earphones or so-called headsets. Shown is a standard earphone 5 in an ear piece 1' is inserted. The connection can be made here as in the other embodiments by gluing, screwing, snapping or in any other suitable manner. To the acoustic properties of the earphone 5 not to be affected, for example, by a headset o.ä. is replaceable, is here ear side in the ear insert 1' a big sound opening 8th' provided with the inserted ear piece 1' points to the auricle. The size of this sound opening 8th' is so on the sound opening of the earphone 5 tuned that the acoustic properties are largely retained. Although here the earmuff 1' is not formed to the entrance of the ear canal, a sufficient attachment in the ear in the areas K is guaranteed. The ear piece 1' Effectively improves the hold of the earphone 5 in the ear of a user and allows the use of commercially available devices without their sound properties to be changed or adapted. Such an ear piece 1' can be prepared by the described or other known methods.

In another version (see 1 ) the physical ear impression is replaced by an impression material by a digital ear impression. The auricle geometry is then digitally detected by means of a suitable scanner operating, for example, with laser light, light, ultrasound, X-rays, etc. In this case, the in 1 under 3D indicated 3D scanning of the molded pieces and in step 4, CAD modeling, the digitally captured auricular geometry data are used to design the ear tip. The ear insert itself is then made, adapted and equipped according to the procedures described above.

Further versions and variations of the present invention will be apparent to those skilled in the art within the scope of the following claims.

1

ear tip

2

fitting

3

Ear insert assembly

4

ear

5

Device for transmission acoustic signals

6

electric wire

7

cavity

8th

sound channel

8th'

9

adapter piece

10

terminal region

11

compl. area

11 '

cover

12

ear contour

13

Ear insert contour (too large)

14

Ear insert contour (too small)

Claims (18)

Method for producing an ear insert ( 1 ), which is individually adapted to the relief of an outer ear canal region adjacent to the ear canal, comprising the steps of: providing a plastically kneadable, non-flowable or only slightly flowable, curable impression material, molding the desired auricle region with the impression mass, without the impression material on the Entrance area out into the ear canal, curing the impression mass to a shaped piece ( 2 ), Removal of the fitting ( 2 ), Detecting the geometry of the fitting by means of a scanning device, in particular a 3D scanner, designing a digital ear insert geometry on the basis of the detected fitting geometry, producing the ear insert ( 1 ) based on the digital earmold geometry using a three-dimensional computer-controlled manufacturing process. The method of claim 1, wherein providing the impression material comprises: mixing a homogeneous impression of two components of an addition-curing Silicone material, wherein the mixed impression mass a life of up to 10 minutes, especially 1-5 minutes and / or in kneadably available during this period stands. Method according to one of Claims 1-2, in which the shaped piece ( 2 ) from the cured impression material has a Shore hardness of 15-95 [Shore A] and / or a shrinkage <0.1% by volume with respect to the starting material. Method according to one of the preceding claims, in which the molding of the desired Pinna area with the impression mass comprises: Cover the auricle with a membrane before molding, with the membrane is so designed that she protects the ear canal against the ingress of molding material and the removal of the hardened Impression material from the pinna area easier. Method according to one of the preceding claims, wherein designing the digital ear insert geometry following steps having: Shapes of the auricle geometry, Shape the free outer surfaces, The method of claim 5, wherein in designing the digital ear insert geometry the auricle geometry gößer or smaller than the molded auricle relief is designed, wherein the under or excess 0.45 to 3 mm, 0.2 to 1 mm or 0.1 to 0.5 mm. The method of claim 5 or 6, wherein designing the digital earmold geometry comprises the steps of: designing at least one lumen (FIG. 7 ) in the ear insert geometry, (eg sound channel ( 8th ), Ventilation channel and receiving space for adapter piece ( 9 ), Power supply, connection geometry ( 11 ), Speaker device, microphone device, amplifier direction, controller) Method according to one of the preceding claims, wherein in the production of the ear insert ( 1 ) at least one of the following three-dimensional, computer-aided manufacturing processes is used: stereolithography, computer-controlled milling or grinding process, 3D printing, laser sintering, vacuum casting, injection molding. Earpiece ( 1 ) produced by a method according to the preceding claims. Ear insert assembly ( 3 ), which an ear insert ( 1 ) according to claim 9, comprising: an adapter cavity ( 7 ), which firmly with an adapter piece ( 9 ), wherein the ear insert ( 1 ) and the adapter piece ( 9 ) complementary surfaces ( 11 ) and the adapter piece ( 9 ) a connection area ( 10 ) for coupling a device ( 5 ) for transmission of acoustic signals. Ear insert assembly ( 3 ) according to claim 10, wherein the device ( 5 ) for the transmission of acoustic signals comprises at least one of the following components: loudspeaker, microphone, power supply, receiving antenna, transmitting antenna, signal connection, power supply, amplifier, sound transducer. Ear insert assembly ( 3 ) according to one of claims 10 or 11, in which the device ( 5 ) for the transmission of acoustic signals as so-called Headset or earphone is formed, which has a loudspeaker arrangement and / or a microphone arrangement. Ear insert assembly ( 3 ) with an ear insert ( 1' ), which has a connection area for coupling a device ( 5 ) for transmitting acoustic signals, in particular a headset or an earphone, having an ear-side sound opening ( 8th' ) whose dimensions are substantially equal to a corresponding sound opening of the device ( 5 ) corresponds to the transmission of acoustic signals. Ear insert assembly ( 3 ) according to any one of claims 10 to 13, wherein the ear insert geometry ( 13 ' ) of the ear insert ( 1 . 1' ) is smaller than the molded auricle relief and has an undersize (b) of 0.45 to 3 mm, 0.2 to 1 mm and 0.1 to 0.5 mm. Ear insert assembly ( 3 ) according to one of claims 10 to 13, wherein the ear insert geometry ( 13 ) of the ear insert is larger than the molded auricle relief and has an oversize (a) of 0.45 to 3 mm, 0.2 to 1 mm and 0.1 to 0.5 mm, respectively. Ear insert assembly ( 3 ) according to claim 15, wherein the cavity ( 7 ) of the ear insert ( 1 . 1' ) is completed completely filled. Ear insert assembly ( 3 ) according to claim 15, wherein the cavity ( 7 ) is filled with a sound-absorbing material. Use of an ear insert assembly ( 3 ) according to one of claims 16 and 17 as hearing protection.