EP1915197A1

EP1915197A1 - Apparatus for the treatment of diseases of the inner ear

Info

Publication number: EP1915197A1
Application number: EP06761280A
Authority: EP
Inventors: Flavio Sardo
Original assignee: Individual
Current assignee: Individual
Priority date: 2005-08-16
Filing date: 2006-08-14
Publication date: 2008-04-30
Also published as: WO2007019720A1; CH699352B1

Abstract

The invention relates to an apparatus (1, 10) for treating diseases of the inner ear by means of light. Said apparatus (1, 10) comprises a light source, an element for injecting light into an ear, and fastening means for fixing the apparatus to the ear such that the injecting element is mounted in a secure manner regarding influences due to movements of the head. Furthermore, the light is introduced into the ear at an irradiation angle which deviates from a vertical lateral direction of irradiation. Preferably, the light source and the injecting element are rigidly interconnected.

Description

DEVICE FOR TREATING INTERNAL ORGAN DISEASES

The invention is in the field of therapeutic and medical devices and relates to a device for the treatment of inner ear diseases, such as tinnitus (, ear noise), tinnitus-related deafness, pressure in the ear, dizziness (Morbus Meniere, Vertigo), hearing loss, hearing distortion or inner ear inflammation.

Devices for the treatment of tinnitus by means of laser light are known. A soft laser in the form of a pin is worn around the neck. The laser light is transmitted to the ear via a fiber cable and into the ear by means of an earplug connected to the cable.

Disadvantage of this design is that a movement of the head, the fiber cable is rotated with respect to the laser and thus pressure on the earplug effect. This may affect the position of the plug, possibly even breaking the earplug.

The object of the invention is to improve the disadvantages of the prior art and to provide a device for the treatment of inner ear diseases, which allows a defined coupling of light into the ear. At the same time, the Device suitable for use on a left and a right ear.

The Aufgäbe is solved by the devices as defined in the claims.

In the inventive device for the treatment of Imienohrerkrankungen a light coupling element to influence, such as displacement, rotation, chutes, etc., due to movements of the body or body parts, in a therapeutic position, attached secured. This is preferably achieved in that the coupling element is rigidly connected to the light source and the device is a fixation to the ear, z. B. on the ear itself or on the head has. Light of a light source is guided and fed directly or via a rigid or rigidly guided light guide into the coupling element. About the coupling element, which is generally formed as an earplug or includes such, light from the light source to the treatment site in the ear out. A coupling element couples the light at a small angle of a few degrees from above and preferably also in a small angle from the rear - both Richtungsangäben seen with respect to a head - a. The angle from above is in a preferred range of about 2 ° -10 °, typically 3 ° -7 °, e.g. B. 5 ° with respect to a horizontal lateral plane. The angle from the back is in a preferred range of about 5 ° -25 ° ₅ typically 7 ° -15 °, z. B. 10 ° with respect to a vertical plane. The angling from a normal direction of incidence permits optimal irradiation of light in a desired therapeutic position, typically involving radiation through the external auditory canal, through the eardrum, and through the oval window. By a rigid arrangement or fixation of the device, an impairment of the attachment of the coupling element is prevented at the ear. Impairment of the attachment arise in particular by rotations of the coupling element relative to the light source by a rotation of a flexible light guide, which guides the light used to treat an inner ear disease from the light source to the ear. The rigid arrangement fixes the coupling element against such twists. If the coupling element is directly and rigidly connected to the light source, no long flexible fiber cables are present. This additionally increases the wearing comfort and in particular the safety risk, since no snagging with the cable and possibly tearing of the device is possible. During a movement of the head, therefore, there are no parts that are not rotated parallel to the head movement. In particular, with a rotation of the head, the entire device moves on an imaginary cylinder circumference about the axis of rotation of the head.

Accurate positioning and retention of the device in a desired therapeutic position, ie, a pre-displacement, torsion, etc. secured ligation element is very important, as treatment of a disease can only be effective if defined and precisely irradiates the site to be treated with light becomes. In particular, the light must reach deep into the ear where the sensitive areas are. The ear is composed from outside to inside essentially as follows: auricle, external auditory canal, eardrum, middle ear with the ossicles Hammer, anvil and stirrup, oval window. Behind the oval window lies the liquid-filled inner ear, which essentially comprises the cochlea and the hearing-sense cells located therein. The vibrations picked up by the eardrum are relayed by the stirrup over the oval window to the inner ear. The pressure fluctuations caused here are then transferred to the basilar membrane - A -

transfer. Everything behind the eardrum is commonly referred to as the inner ear.

The eardrum is irradiated for the treatment of the inner ear. For treatments beyond the oval window, e.g. For tinnitus treatment, the fluid in the middle ear is also completely radiated. This causes a slight attenuation of the light intensity. When using a laser or a laser diode as a light source solid tissue, as it is in the inner ear designed (skin, bone, liquid) up to several millimeters, about 3 -30mm, typically 15-20mm, penetrated.

An adjustment of the device or the incidence of light, as mentioned, is sensitive to the position of the direction of irradiation in the ear. Even the smallest deviations of the light coupling element lead to impairment of the efficiency and quality of the treatment. The exact knowledge of the intensity and duration of the irradiation also makes it possible to assemble individual treatment programs tailored to the persons to be treated. In addition, it is advantageous or necessary for certain treatments in the inner ear to also directly penetrate the oval window. However, this is partially covered by the stirrup located in front of it.

The device preferably has a dispersing medium or an element acting in front of the outlet opening of the light. This causes a widening of a light beam and allows the irradiation of a larger area than the area corresponding to a diameter of the outlet opening or a light guide. In addition, this increases the safety of the device in which no bundled radiation emerges from the device. In one embodiment of the invention, a conventional light source used for the treatment of inner ear diseases, such as a soft-laser (low-level laser), is firmly but preferably detachably connected to an ear piece. The ear part is rigid in itself. A light guide located in the earpiece, z. As a fiber, conducts light from the light source to another end of the earpiece, which serves as a coupling for the light in the ear. Preferably, this other end is provided with a removable and replaceable plug with which the earpiece can be inserted into an ear. The earpiece, or the light guide in the ear part, is designed so that the light at a small angle α of a few degrees from above radiates into the ear canal. Preferably, the light guide is also designed so that light at an angle ß, about twice or three times as large as the angle α, radiating from behind into the ear canal.

The light source and the earpiece are directly, d. H. without flexible light guide, attached to the head. Conventional soft lasers can be used in this device. By a removable light source, this device is also suitable for other treatments, eg. As for the treatment of skin diseases by means of light, which devices only need another laser accessory or generally a light source accessories.

The light source and the earpiece are held for example with a headband on the head. On one side of the headband, the light source and the earpiece is preferably adjustable and removably attached to the bracket. The opposite side exerts counterpressure to balance the weight of the laser and the earpiece.

The headband may include a damping element that allows limited movement of the light source relative to the headband, but at the same time dampens such movement and returns it to its original position. One Damping element, such as a damped return joint, the power of a light source, the z. B. arises due to a quick lifting, lowering or turning of the head to catch. This prevents the device from being torn off during rapid movements. However, the damping element is preferably designed such that the entire device is brought back into the originally set therapy position.

In another embodiment of the invention, a light source including its supply unit is attached directly to the ear. The light source is preferably designed as a laser diode (LED) and integrated in a headset. The headset is attached directly to and substantially parallel to the ear, with a clip to be attached over the ear. The earpiece is designed so that it can be inserted into an ear, z. In the form of an earplug. It has a light beam exit and may be slightly tilted sideways relative to the remainder of the headset, such that it is slightly forward when mounted. To get a slightly down into the ear incident light steel, the earpiece can also point slightly down. But it is also possible to make the light guide in the earpiece pointing down. Bracket and earpiece are preferably both such adjustable, z. B. folded or rotatable that the device is suitable for a right as well as for a left ear, and in particular let the angle of incidence can be adjusted accordingly. A slight bend to the front and back of an ear piece can also be taken over by the pivoting of the temple.

An irradiation direction of light from slightly obliquely behind the top with respect to and into a hearing entrance has proved to be a preferred therapy position for inner ear diseases, in particular tinnitus. The device allows angled radiation of light into an ear by having a light beam angle with respect to the ear. It also allows fixing and holding the device in a previously set position. Depending on Embodiment, the device or parts thereof is automatically returned to an originally set position upon displacement with the appropriate means. The device can also be made very compact, on the one hand, a coupling element is rigidly connected to a light source and on the other hand, a power supply of the light source is housed directly in this. As a result, a substantially fixed unit is formed, without individual parts, which must be connected to each other over long flexible cable or optical fiber.

In the following the invention is illustrated by means of exemplary embodiments. Showing:

1 shows a device with head strap,

2 a head strap laser accessories,

FIG. 3 shows an earpiece of the device from FIG. 1, FIG.

FIG. 4 optical light guide in the device according to FIG. 1, FIG.

5 is a sectional view of a security well plug,

6 is a bow hinge for the device of FIG. 1,

Fig. 7 shows another embodiment of the device installed, Fig. 8 back of the embodiment acc. Fig. 7,

9a, b, the further embodiment for a left and a right ear,

Fig. 10a, b front and interior of the embodiment according to Fig.7. ₅

Fig. 11 a-c side view of an ear with preferred angle of incidence light.

Fig. 12a, b an embodiment with a separate supply unit

FIG. 1 shows the device 1 according to the invention with a soft laser 2, as used for the treatment of tinnitus and other inner ear diseases. Connected directly to the laser 2 is an earpiece 3, which is attached to the laser, for example by means of screwing. The laser 2 is connected via the earpiece 3 with a headband 4. The headband 4 holds the earpiece 3, which serves as a coupling element for light of the laser in the ear, on or in the ear. An end of the headband opposite the laser, for example in the form of a loop, exerts the counterpressure required for this purpose. The earpiece 3 and the laser are attached to the headband 4 fixed to the head and fixed thereto. A movement of the body has no (mechanical) effect on the device. The fact that the light source without flexible parts, such as cable connections, is connected to the earpiece, there is no risk of displacements of the earpiece due to movements of the body or a hanging and / or twisting of a cable. A power source for operating the laser is housed in the laser itself. These can also be rechargeable batteries, which when not in use of the device, preferably without the laser or the device to be taken, for. B. by cable or plug contact, are connected to a power source.

FIG. 2 shows separately a laser accessory which is slightly different from FIG. 1, that is to say the device without a light source. The laser accessory is mounted on the laser 2 in order to be able to drive a laser beam directly into the area to be treated in the ear. This assembly is preferably releasable again, so that a laser or a laser accessory, for example, for cleaning, maintenance or adaptation, or for use with another laser accessory for another application, such as skin treatments, can be replaced. The headband 4 is a lock 5, z. As a clamping device or locking screw connected to the earpiece 3. The lock is as in this figure designed in one piece with the earpiece, as longitudinally continuous opening through the earpiece. The lock can also, as shown in Figure 1, be designed as a separate, attached to the earpiece lock. About the lock, the strap length can be adjusted and adapted to different head sizes. Thus, if necessary, a certain angle, already predefined by, for example, snap-in, or continuously, between bracket 4 and earpiece 3 can be adjusted so that an earpiece in the mounted state for a left or right ear points forward. Such a latching can be carried out, for example, by a single flattened position in the bracket 4 and / or in the lock 5, that it has a self-centering function and the orientation bracket / earpiece when mooring the lock comes to rest automatically in the correct position ,

The ear piece has an ear plug 6 at its end leading to the ear. This is preferably made of a resilient, soft material, such as rubber or plastic, and interchangeable. The earplug 6 is also transparent to the light used or has a corresponding opening to the Passing the light into the ear. In the headband 4 a bow hinge 11 is introduced. Such a bow hinge allows limited movements of an earpiece laser unit with respect to the head. Thus, rapid movements can be damped without that the device shifts significantly and slightly shifted parts of the device, eg. B. by a blow, are automatically returned to a therapeutic position. An example of a bow hinge is shown in FIG.

The earpiece 3 can also be mounted rotated by 180 °, so that a laser 2, similar to an antenna, mounted from above the earpiece, for example, screwed, is. A laser, which is not attached hanging down, has the advantage that the headband is not mechanically influenced by very large shoulder movements in connection with a head rotation and is also suitable for people with a very short neck.

Figure 3 shows the earpiece 3 without locking with a lower cylindrical part 7, which has on its inner or outer side fastening means to a light source, for. As a soft laser to be attached. Such fastening means are for example screw thread, snap devices, bayonet locks, etc. Within a solid sleeve 8, preferably made of metal, directs a light guide, preferably a high-quality glass fiber, a laser beam. The deflection essentially comprises a right angle, such that the beam can penetrate into the ear with a slightly angled downward direction. The located at the upper end of the ear part plug-in part 9 is designed such that an ear plug can be easily plugged and removed. For this purpose, the male part 9 preferably grooves or retaining elements. The earpiece may also be permanently attached to the laser and made of another solid, substantially non-bendable, material.

FIG. 4 shows the optical light guide in the device from FIG. Light generated by the laser 2 is guided by the laser diode 402 parallel to the lens 405. This is located in the ear part 403, which is fastened by means of an internal thread 406 on the laser head. The convex lens 405 focuses the light so that it can be coupled into a glass fiber (fiber not shown). In the glass fiber, the light is deflected, preferably up to a maximum for glass fibers deflection angle of about 80 ° -100 °, z. B. 90 ° with a fiber diameter of about 1.2 mm. Depending on the application and glass fibers are used with other diameters, eg. B. 1.5mm. Glass fibers are already relatively rigid in themselves and are preferably glued to the sleeve only at their beginning and end (not shown). More flexible fiberglass cables should be additionally fixed over their entire length in order to achieve the same stability. The laser light is guided through the continuously opened ear plug 409 in the ear. The coupling-in region of the device comprises an optically dispersing medium or element such that the laser beam is easily dispersed. This allows to irradiate a larger area to be treated. Well-known soft lasers have a typical penetration depth into human tissue of approx. 16mm. By means of a dispersing medium, for example, an area of about 20-30 mm ^{2 is} irradiated in the inner ear, so that approximately volumes of about 3, 3 -5 mm ^{3 are} irradiated. However, such an element also serves as a safety precaution in case the device should emit light without being placed in an ear.

To be anatomically adapted to the outermost ear canal, the ear plug 409, slightly conical in shape, faces the ear with the narrower end. In a preferred embodiment, the ear plug is mushroom-shaped. Such a safety plug 509, as shown schematically in Figure 5, has a thickened, widened edge region, such that it is prevented that the inserted end of the ear part of the device can be inserted too far into the ear or can penetrate, for example in a lateral impact on the mounted device. Other shapes with continuously increasing diameter or one-sided greatly widened edge area can be used as a security ear plug. By means of internal projections 510, which may be located at different locations in the ear plug, the ear plug is held on the coupling element.

FIG. 6 shows a headband 40 with inserted bow hinge 11 '(shown enlarged in the right-hand figure). Such a bow hinge is introduced on the side of the laser 2 in the bracket. It allows a laser to move forward or backward (indicated by arrows) when the head is raised or tilted. The hinge also allows for a suspension of the weight of the laser when a rapid rotational movement of the head takes place. Such a bow hinge can be made for example of a robust piece of plastic, which is cut to both sides wedge-shaped. Through the incision, the mobility and a movement angle can be specified. Also, a ball joint, possibly with laterally restricted freedom of movement, or other acting as a damping element, can serve as a bow hinge. However, the bow hinge is preferably designed so that the light source and the associated coupling device held in the predefined (therapy) position, if necessary, be returned to it.

FIG. 7 shows a device 10 according to the invention in the form of a headset attached directly to the ear. The rear side of the device 10, which faces towards a head when mounted, is shown in FIG. With an earloop 104, the device is attached to the ear, respectively suspended. The material of the strap is preferably elastic and non-slip. It is also preferable bendable, such that the earloop can be individually adapted to different ear shapes. The earloop 104 is attached to the headset housing 101 with a hinge 105. The hinge makes it possible to pivot the ear hook, for example, to allow about 180 °, and thus a hanging of the device from a right to a left ear. The back further comprises the ear part 103, which has a light outlet 12 and serves as earplugs. The ear member 103 is slightly conical in shape and slightly inclined with respect to the housing to the side. A beam of light does not occur so straight, ie vertically out of the housing, but slightly angled. With a slight bend of the ear part, or a light exit direction down, the anatomical direction of an ear entrance is considered. As a result, the device assumes a therapeutic position in which the beam can penetrate unhindered into the interior of the ear, in particular even deep into the inner ear. The ear part 103 is also rotatable, for example by 180 °, such that the ear part 103 assumes its lateral inclination corresponding to a left and a right ear.

FIGS. 9a and 9b respectively show a device according to FIG. 7 for a right (9a) and left ear (9b). The arrow directions indicate the pivoting direction of the earhook. L and R indicate the settings of the ear piece 103 for a left and a right ear, respectively.

If the ear member 103 is designed so elongated that it can penetrate not only to the ear, but a little way into the ear canal, it can be achieved that an automatically correct alignment of the laser beam is achieved, for example, on the eardrum, characterized in that an angling of the vertical irradiation direction in the ear is compensated by a corresponding rotation of the hinge 105. This can simplify the headset and use the device for a left and right ear or a change of the device from one to other ear preferably only by pivoting the earloop 104 can be achieved.

FIG. 10 a shows the front side of the device according to FIG. 7. In the assembled state, it is turned away from an ear and has an on / off switch 13. The front or parts thereof are preferably removable. FIG. 10b shows the device with the front side removed. Shown are a laser diode 102 with any lens and a chip 14. With the help of the chip, for example, the control and control of the diodes and / or battery power is performed, treatment programs can be stored, etc .. Falls, for example, the performance of the batteries 15 under one preset value, the diode starts to flash to indicate a change of the power supply. It is also possible to use rechargeable batteries. However, it should be ensured that the power supply remains as constant as possible, since certain diodes are very sensitive to current fluctuations. Next, the on / off switch 13 'is shown.

FIG. 11a very abstractly shows an ear 111 with a hearing input 113 and a rod-shaped optimized light irradiation direction 112. The direction of irradiation is not perpendicular to the ear 111 or laterally to the head, but is slightly upwards relative to the head or to the ear canal 113 inclined at the back. The two angles of inclination α, β are shown in FIGS. IIb and 11c in a side and bottom view (A, B), but not to the scale. The one angle α is in a preferred range of about 3 ° -8 °, z. B. 5 ° up with respect to an imaginary horizontal plane through the ear canal entrance. The other angle β is in a preferred range of about 5 ° -25 °, z. B. 10 ° backwards with respect to an imaginary vertical plane through the hearing entrance 113. A direction of incidence obliquely from the top back to the bottom, allows an undisturbed penetration of a Light beam through the entire external auditory canal, if desired, through the oval window through to the inner ear.

FIGS. 12a and 12b show a variant of the device with a headband of FIGS. 1-4. The same reference numerals have been used for the same elements. The device is designed to be more balanced in terms of weight, in particular when it is provided with a light source. The earpiece 3 is preferably removable, a light source, for. As a soft laser attached. The supply unit, z. As batteries, a laser, which make up the largest lower part of the laser, are not directly connected to the rest of the laser or the earpiece. The supply unit is designed in the form of a battery housing 112 in FIG. 12a, which housing may be designed substantially identically to the lower part of the laser. In FIG. 12b, the supply is designed as a battery 112 '. The supply unit is mounted on the other side of the headband 4, the opposite side of the earpiece. This is preferably done by means of suitable fastening means, such as screw or snap closures. A battery case 112 may also be fixedly mounted on the headband. However, a supply unit is preferably rigidly connected to the headband and thus in turn rigidly connected to the entire remainder of the apparatus.

Attachment of the supply unit 112, 112 'to the headband typically establishes electrical contact between the supply and the earpiece or light source attached thereto. A power line can be performed directly in or on the headband, for example by means of cables. In FIG. 12a, the battery housing is attached to the headband, wherein cable connections 113 to the battery housing 112 and to the light source or earpiece 3, which are located on the other side of the bracket, are drawn. The cable is passed through a cavity in the headband, so that no loose cable is present. The supply unit 112, 112 'is connected to a light source via a cable, which may be fixedly attached to the unit or to the headband. Supply unit and light source or supply unit and earpiece (if the light source is integrated directly into the earpiece) are both preferably removable. By a removable but firm mounting, it can be prevented that a supply unit hanging around suspended only on a cable, and that the cable is possibly torn from its anchorage. Also, all devices - including the light source with supply unit - are influenced by a movement of the head.

In a preferred embodiment, the laser is a composable unit of light source and supply unit. Thus, a supply unit can be released if necessary from the light source and attached to the opposite end of the headband or vice versa. This allows the use of such a laser in a weight balanced application as a tinnitus treatment device, and also for other applications with light irradiation, e.g. Skin treatments.

In Figure 12b, in which the supply unit is configured substantially in the form of a simple battery 112 ', contact with the light source can be made by attaching the battery. It goes without saying that for attachment of a battery or generally a supply unit, the loop-shaped end of the headband can also be designed differently.

It is also possible to connect a supply unit via a longer cable with the earpiece and this as known from the prior art, for example, in a trouser pocket accommodate. A headband device is suitable for use with a right or a left ear. In order to be able to irradiate two ears at the same time, an earpiece described in FIGS. 1-4 and 12a, b can also be attached to both sides of the headband. This also has the advantage that such a device automatically has the same weight on both sides. The supply units are then preferably integrated in the laser. For irradiation of both ears at the same time it is also possible to use only one light source and to split the light produced by the source. Via an optical fiber, for example again guided in a cavity of the headband, light is guided to an opposite earpiece.

Claims

A device (1) for use in the treatment of ear diseases with light, comprising a fastener for fixing the device to the ear and a coupling element for coupling light into the ear, characterized in that the coupling element for removably and rigidly connecting a light source to the ear Einkopplungselement is configured.

2. Device (1) according to claim 1, wherein the fastening means is a headband (4,40).

3. Device (1) according to claim 1 or 2, wherein the coupling element and fastening means adjustable and releasably, but firmly connected to each other.

4. A device (10) for the treatment of inner ear diseases with light, comprising an earloop for fixing the device to the ear, a coupling element for coupling light into the ear, and a light source, characterized in that the device comprises pivot means (105), such in that the device can be attached to a left or a right ear by pivoting the pivoting means.

5. The device (10) according to claim 4, wherein the pivot means (105) in the assembled state of the device are pivotable about an axis parallel to a body axis.

6. Apparatus (1,10) for the treatment of inner ear diseases with light according to one of claims 4 or 5 or with a device according to claim 1-3, comprising a light source, characterized in that on the device (1,10) has a light beam angle ( α, ß) is defined with respect to the ear, which deviates from a vertical lateral Einstrahlrichrung, and that the device has fastening means for fixing the device to the ear, such that the coupling element is mounted secured against interference due to movement of the head.

7. The device (1,10) according to claim 6, wherein the light irradiation angle (α) 2 ° -10 °, z. B. 5 °, with respect to a horizontal plane.

8. Device (1,10) according to claim 6 or 7, wherein a further Einstrahlwinkel (ß) 5 ° -25 ° ₃ z. B. 10 °, with respect to a vertical plane.

9. Device (1,10) according to one of the preceding claims, wherein the coupling element is designed such that the device is attachable to the left and right ears.

10. The device (1,10) according to any one of claims 4-8, wherein the light source is a soft laser (2).

A device (1, 10) according to any one of claims 1 or 6, wherein a headband (4, 40) comprises a damping element for facilitating movement of a light source attachable or mounted on the headband relative to Headband and for automatic return of the device in a previously defined therapy position at a deflection.

12. The apparatus of claim 1 or 6, wherein a separate supply unit of a light source is mounted on the opposite side of a headband an earpiece.

13. The device (1,10) according to any one of the preceding claims, wherein no flexible, movable optical fibers are present.

14. Device (1, 10) according to one of the preceding claims, wherein the coupling element has a mushroom-shaped Sicherheitshrenropfropf (409).

A method for treating inner ear diseases with light, wherein a light introducing element is attached to a head to introduce light into an ear (111), and light is guided from a light source to the light introducing element, such that the light introducing element is prevented from being affected by movement of the light Head or the light source is secured including their supply unit and wherein the direction of irradiation (112) of the light into the ear at an angle of incidence (α, ß) deviates from a vertical lateral direction of irradiation with respect to the ear.