WO2018024275A1 - Dispositif de couplage à des appareils d'aide auditive sans inconfort pour les patients - Google Patents

Dispositif de couplage à des appareils d'aide auditive sans inconfort pour les patients Download PDF

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Publication number
WO2018024275A1
WO2018024275A1 PCT/DE2017/000246 DE2017000246W WO2018024275A1 WO 2018024275 A1 WO2018024275 A1 WO 2018024275A1 DE 2017000246 W DE2017000246 W DE 2017000246W WO 2018024275 A1 WO2018024275 A1 WO 2018024275A1
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WO
WIPO (PCT)
Prior art keywords
plate
base plate
coupling
bone
user
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/DE2017/000246
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German (de)
English (en)
Inventor
Ralf Siegert
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Individual
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Individual
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Filing date
Publication date
Priority claimed from DE202016004945.4U external-priority patent/DE202016004945U1/de
Priority claimed from DE202017002813.1U external-priority patent/DE202017002813U1/de
Priority claimed from DE202017002979.0U external-priority patent/DE202017002979U1/de
Application filed by Individual filed Critical Individual
Priority to DE112017003844.8T priority Critical patent/DE112017003844B4/de
Publication of WO2018024275A1 publication Critical patent/WO2018024275A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; ELECTRIC HEARING AIDS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00—Electric hearing aids
    • H04R25/60—Mounting or interconnection of hearing aid parts, e.g. inside tips, housings or to ossicles
    • H04R25/604—Mounting or interconnection of hearing aid parts, e.g. inside tips, housings or to ossicles of acoustic or vibrational transducers
    • H04R25/606—Mounting or interconnection of hearing aid parts, e.g. inside tips, housings or to ossicles of acoustic or vibrational transducers acting directly on the eardrum, the ossicles or the skull, e.g. mastoid, tooth, maxillary or mandibular bone, or mechanically stimulating the cochlea, e.g. at the oval window
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; ELECTRIC HEARING AIDS; PUBLIC ADDRESS SYSTEMS
    • H04R2460/00—Details of hearing devices, i.e. of ear- or headphones covered by H04R1/10 or H04R5/033 but not provided for in any of their subgroups, or of hearing aids covered by H04R25/00 but not provided for in any of its subgroups
    • H04R2460/13—Hearing devices using bone conduction transducers

Definitions

  • the invention relates to an easy-to-handle universal device for transmitting vibrations generated by hearing aids on a skull of a user and the use of the device for releasable patient-friendly coupling to hearing aids for transmitting vibrations generated by hearing aids on a skull of a user.
  • electrical hearing aids which transmit the hearing-impaired to be transmitted sound signal as an acoustic vibration on the skull bone.
  • Those of a, e.g. electro-magnetic, receiver generated with the sound signals corresponding electrical signals are amplified by an amplifier, preferably comprising a signal processing unit according to predetermined specifications to amplifier signals and forwarded to an output transducer.
  • the output transducer can be used as an electro-acoustic transducer or as an electro-mechanical transducer, such as a bone conduction transmitter, e.g. for generating output signals, such as vibrations, to provide conventional, e.g. implantable or non-implantable, such as vibrotactile bone conduction hearing aids.
  • the device to be provided should, in interaction with the preferably vibrotactile hearing device, use the natural sound processing in the human ear as unadulterated as possible and help to avoid the occurrence of vibrations and interfering couplings in contrast to the prior art.
  • the sound signal is transmitted to the skull in the form of vibrations.
  • mobile, non-implantable bone conduction hearing aids they are pressed with their electro-mechanical transducers by means of elastic brackets or headbands fixed to the head, so that the vibrations generated by the electro-mechanical transducers are transmitted through the skin on the cranial bones of the user ,
  • transcutaneous arrangement of the transducer also called output transducer
  • transducer also called output transducer
  • the field of this permanent magnet acts through the scalp on an implant anchored subcutaneously in the cranial bone, such as magnets or on ferromagnetic materials, whereby the force caused by the magnetic field between the transducer and the implant can enable transmission of the oscillation to the cranial bones.
  • implant anchored subcutaneously in the cranial bone such as magnets or on ferromagnetic materials
  • a screw may be screwed into the cranial bone, wherein the screw head or a spacer sleeve can not be covered by the scalp and the electro-magnetic transducer set this screw into mechanical vibrations, which are transmitted from the screw to the cranial bone.
  • the holder of the bone conduction hearing aids by means of permanent magnets or couplings.
  • this prior art is characterized by the disadvantage that the pressing of the straps or headbands considerably limits the wearer comfort of the user and the appearance of the user generated as a result of strap or headband on third parties can be perceived by the user as at least aesthetically limited , Therefore, it is also an object of the invention to provide a device for coupling to a preferably vibrotactile, non-implantable bone conduction hearing aid which does not limit wearer comfort for the user and does not substantially limit the user's appearance to a third party.
  • the device to be provided for coupling to a preferably vibrotactile, non-implantable bone conduction hearing device should be designed such that it is self-finding, thus facilitating the coupling and alignment of the bone conduction hearing aid to the device.
  • the application of force generated by the coupling should be directed to the largest possible area of the skin of the user in order to avoid irritable skin as a result of the pressure.
  • the force distribution of the anatomy and physiology of the skin surface should be adjusted by the individually determinable shape.
  • the device should be suitable both for resting on the skull of the user as well as for insertion into a milled area of the skull of the user, so that the surgeon on site, ie during surgery, depending on the nature of the skull bone thickness, on the type of connection the device can decide with the skull bone.
  • the device to be provided should be suitable both for connection to the infant's cranial bone and that of adults, without the need for reconfiguration or adaptation of the device. In addition, it should be as small as possible by the preparation of the device to be provided with the cranial bone compression thereof.
  • the scalp is to be acted upon by the device only with a sufficiently low force, so that no significant reduction in the perfusion of the scalp is observed.
  • the device should offer the user the ability to change the spacing of the bone conduction hearing aid of the scalp.
  • the device should also be usable with a scalp of a user who is characterized by easily vulnerable connective tissue, such as granulation tissue.
  • the device should provide the opportunity to treat occurring granulation tissue by customizable distances and pressure settings of the outer parts of the same by pressure therapy.
  • the sound can be done as bone sound directly to the inner ear, bypassing the sound conduction apparatus of the outer ear and the middle ear.
  • the coupling of solid-state sound to the bone can be done by means of vibrators, which are pressed by external pressure or magnetically to the scalp or open implants. Both methods have different disadvantages. These include, on the one hand, the fundamental problems of open implants -see above-and, on the other hand, the sometimes unpleasant pressure generated by means of braces or headband the head, the aesthetically disturbing temple and in both procedures the need for surgery.
  • a transcutaneous, magnetic fixation is recommended.
  • one or two magnets have previously been implanted on or in the cranial bones, the skin thinned out according to individual requirements and the external hearing device fixed with the aid of one or two magnets. This technique requires surgery. There are several principles for this:
  • the bone is milled out according to the shape of the magnets and the magnets are embedded in the bone. As a result, any disturbing increase is largely avoided, but requires a certain bone reduction with the appropriate effort and risk.
  • a thin magnet is positioned on the bone and fixed with small screws. Bone cuts are not required, but the implant contributes something according to its thickness. A smooth surface is advantageous for better force distribution and thus pressure reduction. This can be achieved by another, the shape of the magnets covering implant, z. B. silastic, can be achieved.
  • a comparatively thick screw is inserted into the bone, to which a magnet is anchored. This also requires bone reduction and the magnet is wearing, ie it is above the bone level.
  • the method to be chosen is chosen according to the individual situation, such as age of the patient, bone thickness, malformation, etc. Whether and how deep it is possible to mill with methods 1 and 2 is often decided intraoperatively on the basis of the bone thickness and possibly exposed dura.
  • the object of the invention relates to an easily manageable universally applicable Apparatus for coupling to hearing aids, for example, preferably vibrotactile bone conduction hearing aids, for transmitting, for example, their output transducers, such as electro-mechanical transducers, output signals, such as vibrations, to a cranial bone of a user,
  • hearing aids for example, preferably vibrotactile bone conduction hearing aids
  • output transducers such as electro-mechanical transducers
  • output signals such as vibrations
  • a plate as an implant with its underside for connection to the cranial bone, on the side of which arms, also referred to as osteosynthesis arms, are formed, the arms having openings for screws, also referred to as osteosynthesis screws,
  • a base plate for application from the outside against a scalp of the user, which has a central region and an adjoining the central region, preferably extending around the central region, extending edge region,
  • the base plate and / or the plate comprise a magnetic material, preferably an underside of the edge region of the base plate and an underside of the edge region adjoining underside of the central region of the base plate form an angle with that of the underside of the arms and the underside of the Plate included angle, eg Angle, matches,
  • one of the underside of the central region facing away from the upper side of the central region and / or the edge region of the base plate for positive, frictional and / or non-positive coupling to hearing aids is suitable.
  • the invention is also directed to an easy to handle universally applicable device for transmitting, preferably generated by electro-mechanical transducer, hearing aids generated output signals, such as vibrations, on a skull bone of a user,
  • a, preferably elastic such as a thermoplastic or thermoelastic film, one side of which is at least partially coated with an adhesive layer for application against the scalp of a user
  • the film contains a magnetic material or the other side is provided with a magnetic material
  • the hearing aid can be coupled.
  • the magnetic material is designed as a permanent magnet material, preferably contains a neodymium-iron-boron alloy.
  • this film contains a non-magnetic material, in which one or two magnets are embedded, to which the or certain components of the hearing aid are coupled.
  • the invention is also directed to an easily manageable, universally applicable device for transmitting, preferably from output transducers, such as electro-mechanical transducers, generated, hearing aids generated output signals, such as vibrations, on a cranial bone of a user,
  • a, preferably elastic such as a thermoplastic or thermoelastic film whose one side is coated with an adhesive layer for application against the scalp of a user,
  • the film comprises a non-magnetic material, in which or on the one or two magnets arranged, welded or glued, are, to which the or certain components of the hearing aid can be coupled, preferably the magnets include a permanent magnet material, e.g. a neodymium-iron-boron alloy.
  • the invention relates to a use of the device for releasably coupling to a hearing aid with an input transducer, an amplifier and an output transducer, the sound signals picked up by the input transducer are passed on to an amplifier as electrical signals corresponding to the sound signals, from the amplifier the amplifier signals generated by the latter corresponding to the electrical signals are passed to the output transducer, from the output transducer the output signals corresponding to the amplifier signals, as vibrations are generated, the output signals, such as vibrations, are transmitted to the device, which comprises a plate as an implant with its underside for connection to the skull, on the side arms are formed as Osteosynthesearme, the arms breakthroughs for screws, as osteosynthesis screws
  • the device which comprises a plate as an implant with its underside for connection to the skull, on the side arms are formed as Osteosynthesearme, the arms breakthroughs for screws, as osteosynthesis screws
  • the base plate for attachment from the outside against a scalp of the user a mi having a substantial area and a peripherally
  • the invention also relates to a method for transmitting output signals corresponding to sound signals, such as vibrations, wherein a device is coupled to a hearing device, which comprises an input transducer, an amplifier and an output transducer,
  • a plate as an implant with its underside for connection to the cranial bone, at the side arms are formed as Osteosynthesearme,
  • the arms have apertures for screws as osteosynthesis screws, preferably an underside of the arms with the underside of the plate an angle ⁇ less than or equal to 180 °,
  • a base plate for externally fitting against a scalp of the user a central area and extending around the central area extending
  • the base plate and / or the plate contain a magnetic material, preferably an underside of the edge region of the base plate and an underside of the edge region adjoining underside of the central region of the base plate enclose an angle ⁇ , which coincides with the angle ⁇ ,
  • one of the underside of the central region facing away from the top of the central region and / or the edge region of the base plate for positive and / or frictional and / or non-positive coupling to hearing aids is suitable.
  • the invention is also directed to an easily manageable, universally applicable device for coupling to hearing aids, for example, preferably vibrotactile bone conduction hearing aids, for transmitting, e.g. generated by their electro-mechanical transducers, output signals, such as vibrations, on a user's bones,
  • a plate as an implant with its underside for connection to the bone, on the side of which arms, also referred to as osteosynthesis arms, are formed, the arms having openings for screws, also referred to as osteosynthesis screws,
  • a base plate for fitting externally against a bone-covering skin of the user, which has a central region and an edge region extending circumferentially around the central region,
  • the base plate and / or the plate comprise a magnetic material, preferably an underside of the edge region of the base plate and an underside of the edge region adjoining underside of the central region of the base plate form an angle, in particular which with the underside of the arms and the underside
  • the plate included angle eg angle, coincides, one of the underside of the central region facing away from the top of the central region and / or the edge region of the base plate for positive and / or frictional and / or non-positive Coupling to hearing aids is suitable.
  • the plate and the base plate are made with a magnetic material.
  • the plate and base plate designed as magnetic disks or having such magnetic disks may be designed as permanent magnets or permanent magnets as magnetic material or contain such disks, so that due to the hard magnetic properties of the magnetic material or the magnetic disks coupling, also called magnetic coupling, the Base plate on the plate in the coupling position, even if they are spaced from each other by the scalp of the user between them, fatigue-free and remains secure and the user is not exposed to the risk of loss of the base plate with the hearing aid coupled to him.
  • a magnetic material is also understood as meaning a material with a hard-magnetic material, for example alloys with iron, cobalt, nickel and / or ferrites;
  • alloys containing samarium-cobalt or neodymium-iron-boron alloys are materials with strong permanent magnetic fields to provide strong permanent magnets or permanent magnet discs for the plate, base plate, and / or part of the hearing aid.
  • Magnetic materials, which as permanent magnets can have a high coercive field strength, are likewise known to the person skilled in the art, and the external magnetic field fields can oppose a high resistance to magnetic reversal.
  • the plate and the base plate which for example have a neodymium-iron-boron alloy as a magnetic material, advantageously form such a strong permanent magnetic field that the two adjacent magnetic disks of the plate and base plate are permanently attracted to the coupling position even in the event of vibrations, such as tremors, or jerky Head movements can remain;
  • this can also be coupled to the hearing aid in a magnetic coupling position, since the base plate facing bottom of the conventional hearing aid also contains the magnetic material, such as the neodymium-iron-boron alloy, to increase the coupling reliability of the hearing aid in coupling position.
  • the base plate may be formed with magnets of different sizes or magnetic disks, as well as with different large diameters and / or thicknesses, and / or magnetic materials having different magnetic force effects.
  • At least one pin is integrally formed on the upper side, preferably on the upper side of the central region, of the base plate for coupling to the hearing aid;
  • the pin is formed conically and bluntly ending for positive engagement in the hearing aid, so that a positionally secure, albeit by the user detachable, holder between the device and the hearing aid or aligned determination of hearing aid is provided with or on base plate.
  • the device according to the invention is at least one pin on the top, preferably at the top of the central region of the plate molded; to be able to intervene under positive engagement in the base plate.
  • the plate is connected via its pin to the base plate and the hearing aid, so that due to magnetic attraction both the base plate held in the region of the plate and the hearing aid are coupled to the base plate; Accordingly, depending on the requirement on site and depending on the configuration thereof and on the underside of the hearing device, the pin can advantageously have the magnetic coupling position of base plate to plate and / or magnetic coupling position of hearing device to base plate and / or magnetic coupling position of hearing aid on base plate to support disk.
  • the base plate has such a recess, which is able to receive the pin of the plate and / or the auxiliary plate in a form-fitting manner; the depth of the recess can determine the extent of insertion of the pin and thus the spacing of the base plate from the scalp.
  • the pen can preferably support both the self-discovery of the attachment of the base plate against the scalp and the orientation of the coupling to the base plate hearing aid.
  • the device according to the invention is suitable for movements restricted users or for the general disabled, since both due to the particularly advantageous first realized self-finding of attaching the base plate against the scalp and the self-finding the orientation of the coupling to the base plate hearing aid third party support measures or at least presence third it is not necessary to intervene and thus the self-esteem of the user is increased without the need for the help of third parties.
  • the alignment can therefore be effective both by the special design of the pin and the recess receiving it as well as by the orientation of magnetic fields induced by the plate and base plate and / or hearing aid magnetic materials get supported.
  • an auxiliary plate for transcutaneous insertion in a region of the cranial bone is provided in order to support the advantageous magnetic coupling of base plate to plate; e.g. may be equally well formed on an upper side facing away from the plate of a connectable to the plate, preferably arranged transcutaneously, auxiliary plate of the pin for connection to the base plate or engagement in the same; this pin passes through the scalp of the user outwardly to the outer form, frictional and / or non-positive, connecting to the base plate or engaging in the base plate;
  • the pen is arranged percutaneously.
  • the plate comprises a, preferably in the circumferential direction about the longitudinal axis X or A extending outside arranged edge collar having plate ring, a inserted into the plate ring first disc and a patch on the first disc second disc the pin formed on it;
  • the plate comprises a, preferably in the circumferential direction about the longitudinal axis X or A extending outside arranged edge collar having plate ring, inserted into the plate ring first disc and possibly a patch on the first disc second disc without a pen.
  • the plate ring, the first disc and / or the second disc may contain magnetic material; Also, the first disc and / or the second disc may be formed as magnetic discs.
  • the base plate may also comprise a first base ring, preferably a circumferential inner circumferential collar extending around the central longitudinal axis, a base disc inserted into the space bounded by the inner collar and one, preferably one in the direction of rotation running around the center-longitudinal axis, outside arranged outer collar having, the second base ring, wherein, for example, the upper side is retracted to form a marginal extending around the center longitudinal axis bevel, which is form-fitting against the first base ring attached;
  • the first base ring, the base disc and / or the second base ring may include magnetic material;
  • the base plate may be formed as a magnetic disk.
  • magnetic fixation is also understood to mean a connection or coupling caused as a result of magnetic attraction.
  • connection of the plate of the device according to the invention with the cranial bone e.g. their placement on the cranial bones of the user, their at least partial insertion into a milled cavity or area of the skull of the user, etc., understood.
  • osteosynthesis screws as those which contribute to the rapid and trouble-free connection of the plate to bones, such as cranial bones, and thereby also can support the functionality of the hearing organ.
  • plastic-like material is also understood to mean any plastic which is applied to the scalp by means of an adhesive layer and remains there for a certain period of time.
  • plastic material is also understood to mean any plastic which is applied to the scalp by means of an adhesive layer and remains on the same position for a predetermined period of time and which causes no irritation on the user's scalp as a result of remaining.
  • film is also understood to mean an elastic, for example a thermoelastic, or a plastic, such as a thermoplastic, film or one whose areas have parts of different elasticity and / or plasticity.
  • hearing aids also mean bone conduction hearing aids.
  • the device according to the invention for transmitting, advantageously electro-mechanical transducers of, hearing aids to a cranial bone of a user may also be used as a, e.g. elastic or thermoelastic film may be formed, one side of which is coated with an adhesive layer for application against the scalp of a user whose other side contains a magnetic material as an elastic coating against the other side of a magnetic material containing disc is detachably attached as a magnetic disc to which the hearing aid can be coupled, wherein the elastic coating contains as a magnetic material a permanent magnet material, preferably a neodymium-iron-boron alloy.
  • this film may contain a non-magnetic material, in which one or two magnets are embedded, to which the or certain components of the hearing system, such as the hearing aid, are coupled or coupled.
  • the inventive device for coupling to hearing aids the uses of the invention and the inventive method for transmitting vibrations generated by the electro-mechanical transducers with all the above are suitable Embodiments and embodiments disclosed below also on other bones of a user, which is characterized for example by a plate as an implant with its underside for connection to the bone, on the side arms are formed as Osteosynthesearme, the arms have openings for screws as osteosynthesis screws, a base plate for application against a skin of the user overlapping or covering the bone, has a central region and an edge region extending around the central region, the base plate and / or the plate contain a magnetic material, an upper side of the central side facing away from the underside of the central region Area and / or the edge region of the base plate is suitable for coupling to a hearing aid.
  • the device according to the invention is characterized by, inter alia
  • Skull bone, scalp and base plate a cross section through the device according to the invention with plate, Pin, skull bone, auxiliary plate, scalp and base plate,
  • FIG. 6 is a side view of the plate with pin of the device according to the invention.
  • 1 1 is a side view of the base plate of the device according to the invention.
  • Fig. 13 shows a cross section through the upper ring of
  • Fig. 14 is a plan view of elastic films with adhesive layer areas for
  • Fig. 15 is a plan view of elastic films with adhesive layer areas for
  • Fig. 16 is a plan view of elastic films with Kleb Anlagenlen and Magnetic discs for holding the hearing aid
  • 17 shows a cross section through an elastic film with disc, hearing aid
  • Fig. 20 is an enlargement of the inside bevel of the upper ring of
  • Fig. 21 is a longitudinal section through the auxiliary plate 6 as an additional implant.
  • a flat, roundish or oval magnet shape for plate 1 as implant and base plate B is proposed, which does not need to be sunk in bone K, such as the cranial bone.
  • the north-south polarity of the magnet is either linear or circular.
  • At the edge of the magnet are multiple small Osteosynthesearme 2, which are pressed against the surrounding bone K and at least partially fixed with small osteosynthesis screws in bone K.
  • These osteosynthesis arms 2 may comprise different numbers. With seven evenly distributed arms 2, three screws are sufficient to securely fix the plate 1 in the bone K.
  • the holes or apertures 3 for receiving the osteosynthesis screws are not attached to the ends of the arms 2 but are removed a few millimeters therefrom. The reaching beyond the holes webs are flattened, so that they rest against the bone K even smoother. Since there are various osteosynthesis screws with different diameters and shapes, the holes also have different diameters and shapes, so that many different types of screws for the fixation of the plates 1 can be used. In addition to the diameters of the screws or holes 3 and the shape of the screw head underside plays a role for the optimal adjustment, so that the holes are tapered conically or spherically corresponding to the screw heads.
  • the screws 3 are partially oval in one embodiment of the device according to the invention designed. In order to accommodate screws with different diameters, it is proposed to make the holes 3 drop-shaped.
  • the osteosynthesis arms 2 are asymmetrically mounted with respect to the height of the implant in the case of very small, especially childish, bone K, the implant is positioned on the bone K, possibly after a slight smoothing of the bone surface, so that it easily applies according to the plate thickness.
  • the base plates to be supported externally, to which the active part of the hearing system is fixed, have in another embodiment of the device according to the invention to the plate 1 one or two congruent magnets, the strength of which individually Skin thickness, such as scalp thickness, and patient desires.
  • the external base plates B are available with surfaces of different sizes, typically from about 2 to 7 cm 2 .
  • they have different degrees of curvature, also to adapt to the individual curvature of the scalp H on.
  • the bending does not result from the magnet itself, but rather from the osteosynthesis arms 2 pressed against the bone K, it is proposed that the bending is not uniform in the sense of a spherical segment, but that it should be bevelled to different extents outside the radius of the magnet.
  • auxiliary plate 6 is proposed as auxiliary implant 6, which can be introduced in addition to the described plate 1 as an implant. It is magnetically fixed on the first and has a pin 6a which perforates the scalp H and to which a base plate B constructed therefor is fixed. About this pin 6a of the solid-state sound, which is generated by the output transducer, such as the external vibrator, the hearing aid, directly into the plate 1 and further into the bone K is passed.
  • This auxiliary plate 6 as an additional implant consists of a magnetic disc whose magnetization direction to the plate 1 congruent, so either radial or linear, is. It is positioned in the context of an operation after raising the skin flap on the plate 1 as an implant and magnetically fixed on this. Central to this additional implant is the pin 6a, whose length is chosen according to the skin thickness so that it projects beyond the scalp H or the soft tissue over the plate 1 by a few millimeters. The scalp H is punctured at this point, ie centrally above the plate 1 as an implant, and the pin 6a is guided through this opening.
  • the external base plate B centrally has a recess 5a, for example as a milled hole for receiving the pin 6a. It also has a magnet congruent with the implant to magnetically fix the external hearing aid and / or the plate 1.
  • the recess 5a is not continuous, but has a certain hole depth. The height of the base plate B above the skin H or its maximum pressure is determined by the depth of the recess 5a as a milled hole 5a in the base plate B in relation to the length of the pin.
  • a further modification of the fixation of the base plate B consists in a further embodiment of the device according to the invention in that the pin 6a and the recess 5a in the base plate B are congruent with one another in a conical shape.
  • auxiliary plate 6 As an alternative to the auxiliary plate 6 is proposed in a completely different embodiment of the device according to the invention that the pin 6a is formed directly on the plate 1, that is on the implant, so that no auxiliary plate 6 is required.
  • the small skin opening is to be oversewn.
  • the implants have in a further embodiment of the device according to the invention central pins with different lengths, which can be adapted to the individual skin thickness. If the skin swells significantly postoperatively, the pin could be shortened with a diamond bur without reoperation. Should it - for whatever reason - come to a significant skin swelling postoperatively and thus the pen be too short, the skin can be compressed by appropriately strong base pads to their original thickness. A change of the implant to another with a different pen length is possible by a small operation, but clinically hardly necessary.
  • the base plates and osteosynthesis arms of all implants are identical.
  • the existing screws and holes can be used again. If the screws can not find sufficient support in this they can be exchanged for so-called safety screws with a slightly larger thread diameter.
  • the implant can be rotated by a small angle and the boreholes can be re-applied.
  • the base plate B corresponds to the previously described base plate for the percutaneous additional implant (see DBGM 20 2016 004 945.4).
  • the wearing comfort of bone conduction hearing aids without surgical intervention has hitherto been limited, inter alia, by the external pressure and the necessary aids such as headband, strap or strong spectacle frame.
  • the device according to the invention is proposed in another embodiment of a flexible magnetic film 7, the shape of the hairless area behind the auricle, separated for right and left to give. This is preferably fixed with thin double-sided, approved for use on the skin adhesive film or liquid adhesive and can there for some time - according to previous experience several days - left.
  • the film 7 with the magnetic coating be made dorsally larger than it corresponds to the hair-free area.
  • the part 8 of the film 7 projecting into the hairy region has no adhesive film, so that the underside of the film has an adhesive layer as an adhesive area 7a and a non-adhesive area 8;
  • the area 7a for example the part adjacent to the ear, can also be vice versa
  • Film 7 non-adhesive, and the area 9, for example, the spaced from the ear part 8, adhesive be formed.
  • the film 7 is made of a thermoplastic material which is individually adapted to the shape of the head.
  • Advantage of this embodiment of the device according to the invention is that the film rests fit the scalp.
  • the film 7 on no magnetic material instead, one or two magnets 10, such as magnetic disks 10, are inserted in the film 7 at the points at which the hearing aids or their components are carried.
  • one or two magnets 10, such as magnetic disks 10 are inserted in the film 7 at the points at which the hearing aids or their components are carried.
  • the bone conduction hearing aid 9 can be worn temporarily as needed and fixed magnetically on the film 7. This is done either on the hearing aid - for the teilimplantierbare variant anyway - present ferromagnetic disc 10 or an additional device to be fixed, thin ferromagnetic plate, which is connected depending on the design of the hearing with this. While the withdrawal force perpendicular to the film 7 from the magnetic forces and / or the iron content of the disc 10, the lateral displacement force, which is crucial in upright posture for the fixation of the device, in addition to the frictional forces upon movement of the disc on the film. 7 dependent. To increase this, the top of the film 7 and the bottom of the disc 10 are rough.
  • the shape of the film 7 is adapted as a magnetic film the hair-free area behind the pinna, wherein the underside facing the scalp H with an area which is provided with an adhesive layer, and a non-adhesive area 8 designed are, and their top and the bottom of the magnetic disk 10 are designed to be rough.
  • the plate 1 has in a preferred embodiment of the device according to the invention a flat, roundish to oval shape and at the edge of multiple arms 2, also called osteosynthesis arms 2, on; wherein the north-south polarity of the magnet has a linear geometry or has a circular geometry.
  • the plate 1 may have a grid instead of the multiple, individual osteosynthesis arms as an implant; the holes or apertures 3 have different diameters for receiving screws in the grid or the webs and may be chamfered differently for receiving screws with a conical or spherical underside of the screw head.
  • the holes 3 are elongate or drop-shaped so that the screws can slide into it until final fixation.
  • the webs protrude beyond the holes in the osteosynthesis plates, as can the webs or grid ends, which protrude beyond the holes, be flattened.
  • the osteosynthesis arms 2 are asymmetrically mounted with respect to the height of the implant.
  • the underside of the base plate B facing the plate 1 is curved in one embodiment, e.g. is the bottom of the edge portion 5 of the base plate B is angled toward the plate 1; Also, the underside of the base plate B can be centrally flat and peripherally inclined.
  • An auxiliary plate 6 as an additional implant for the device according to the invention for the magnetic fixation of bone conduction hearing aids 9 consists in an advantageous embodiment of the device according to the invention of a plate 1 or base plate B congruent magnetic disc, which has a central pin 6a for perforation of the overlying scalp H; the base plate B has a central recess 5a as a hole congruent to the pin 6a of the auxiliary plate 6 as an additional implant, wherein the centrally aligned in the base plate b e recess has a depth limit for the pin 6a.
  • the pin 6a and the central hole are designed to be congruent with each other as a recess 5a in the base plate.
  • the pin 6a is angularly formed with sides of unequal width, so that the pin 6a positively engages in the recess 5a of the base plate B with its inner sides adapted to the outer shape of the pin 6a for predetermined alignment of pin 6a with the base plate B.
  • the pin 6a is angularly formed with unequal width sides, so that the pin 6a in the recesses 5 a of the base plate B and the hearing aid 9 with their outer shape of the pin 6 a matching inner sides form-fitting and without intermediate play - that is, it engages precisely with the predetermined alignment of pin 6a with the base plate B and with the hearing device 9.
  • the sound can be done as bone sound directly to the inner ear, bypassing the sound conduction apparatus of the outer ear and the middle ear.
  • the coupling of solid-state sound to the bone can be done by means of vibrators, which are pressed by external pressure or magnetically to the scalp or open implants. Both methods have different advantages and disadvantages. It must be individually determined which adaptation is optimal in the individual case. For various medical reasons, it may be useful to switch from one solution to another over time. This also includes the fundamental problems of open implants as well as the sometimes unpleasant pressure on the part Head, the aesthetically disturbing strap and in both procedures the need for surgery.
  • a small, flat magnet is connected as a magnetic disk 10 with an elastic film 7 for providing a Klebefixation of bone conduction hearing aids by means of film 7.
  • the magnetic disk 10 may be depending on the device to be fixed axially or diametrically magnetized. In the case of axial magnetization, small increases and congruent depressions can be used for rotational stabilization of the devices to be coupled.
  • the disc may also consist of a ferromagnetic material.
  • the film 7 surrounds the magnetic disk 10, wherein the magnetic disk 10 adheres to, in or on the film 7 or it is glued individually after adaptation to the adhesive surface.
  • the scalp-facing underside of the film 7 is provided with a skin-friendly adhesive.
  • the shape of the film 7 is adapted to the region behind the auricle separated from the side and can be individualized.
  • the hearing aid 9 itself is then held on the magnet or the ferromagnetic disc 10 by another bonded congruent magnet in the base plate B, wherein the elastic foil for adhesive fixation of bone conduction hearing aids is individualized depending on the shape and size of the foil to be covered Area of the scalp, on or on which a magnetic layer or a ferromagnetic disc arranged as fixed, is.
  • the magnet or the ferromagnetic material have Elevations or depressions in which congruent elevations or depressions of the base plate of the hearing aid arrest.
  • the easily manageable universal device according to the invention for coupling to hearing aids 9 for transmitting vibrations generated by an output transducers as electro-mechanical transducers on a cranial bone of a user comprises a plate 1 as an implant with its underside for connection to the cranial bone K whose side la arms 2, called so-called osteosynthesis arms, are formed, the arms have 2 openings 3 for screws as so-called osteosynthesis screws.
  • a cavity Kl is milled out of the skull bone, which receives the plate 1 at least partially positively, so that the arms 2 of the plate 1 rest on the cavity Kl delimiting area of the skull bone K or the plate 1 with a part of the top of the skull bone K protrudes.
  • An underside of the arms 2 close to the underside of the plate 1 an angle ⁇ less than 180 ° include, a base plate B for attachment to a scalp of the user a central region 5b and a subsequent thereto, preferably around the central region 5b circumferentially extending edge region 5, wherein the base plate B and the plate 1 contain a magnetic material, an underside of the edge portion 5 of the base plate B with the bottom of the central portion 5b of the base plate B include an angle ⁇ , which coincides with the angle ⁇ ,
  • An upper side of the central area 5b facing away from the lower side of the central area 5b and of the edge area 5 of the base plate B is suitable for magnetic coupling or for positive and / or frictional and / or non-positive coupling to a hearing device 9.
  • a pin 6a for coupling to the hearing aid is formed on the upper side of the central region of the base plate B; the plate 1 is in another embodiment via a pin 6a with the base plate B and / or the Hearing aid (9) connected, which is integrally formed on an upper side of the plate 1.
  • auxiliary plate 6 of the pin 6a for connection to the base plate B is formed so that the plate 1 for transcutaneous connection with the skull bone K, the pin 6a for percutaneous arrangement and the auxiliary plate for transcutaneous insertion in a region of the skull bone K are advantageously suitable.
  • the plate 1 comprises a plate ring 6b having an outer peripheral edge 6e extending in the circumferential direction about the center longitudinal axis A of the plate ring 6b or the pin 6a, a first plate disc 6d which can be inserted into the plate ring 6b, and also a first disc 6d, and a second disc 6c, also called a second disc 6c, which can be placed on the first disc 6d, with pin 6a;
  • the base plate B comprises a first base ring 21, which has an inner collar 21a running in the direction of rotation about the center longitudinal axis A of the plate ring 6b, a base plate 22 which can be inserted into the space defined by the inner collar 21a, and one, preferably one in the direction of rotation about the middle - Longitudinal axis X of the first base ring 21 or second base ring 23 extending outside arranged outer collar having, second base ring 23, in particular its top is retracted to form a marginal about the center
  • the base plate B are set against the scalp of the user such that the chamfer 23 a at the edge of the plate at least partially by the skull bone K above arranged plate 1 produced protrusion of the scalp, which protrudes from the rest of the scalp area, can protectively abut.
  • the first disc 6d or the second disc 6c of the disc 1 as magnetic discs
  • the first disc 6d and the second disc 6c of the disc 1 together as magnetic discs, in an array , wherein the adjacent polarities are different, formed.
  • the plate ring 6b, the first base ring 21, the base plate 22 or the second base ring 23 of the base plate B made with magnetic material in another embodiments of the device according to the invention are at least two representatives of the plate ring 6b, the first base ring 21, the base plate 22 or the second base ring 23 of the base plate B comprehensive group made with magnetic material.
  • connection of two parts of the device according to the invention such as pin of the plate with base plate, plate with base plate or hearing aid with base plate, or the engagement of one part in the other part of the device according to the invention, such as pin in base plate , or the fitting of the one part, such as the base plates, understood against the scalp or skin, so that advantageously the center longitudinal axis A of the pin 6a with the center longitudinal axis X of the base plate B can match; under magnetic coupling position, the joining, the engagement or the attachment by means of the magnetic attraction of the parts generated as a result of the magnetic material is also understood in the sense of the invention.
  • this comprises an elastic film 7, one side of which is coated with an adhesive layer for application against the scalp of a user whose other side contains a magnetic material, against the other side of a magnetic material containing disc 10th is detachably attached as a magnetic disk to which the hearing aid can be coupled, wherein the magnetic material is formed as a permanent magnet material, preferably contains a neodymium-iron-boron alloy.

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Otolaryngology (AREA)
  • Neurosurgery (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Acoustics & Sound (AREA)
  • Signal Processing (AREA)
  • Details Of Audible-Bandwidth Transducers (AREA)

Abstract

L'invention concerne un dispositif universellement utilisable et facile à manipuler pour le couplage, sans inconfort pour les patients, d'appareils d'aide auditive par transmission osseuse pour la transmission de vibrations sur un os crânien d'un utilisateur. Une plaque servant d'implant avec sa face inférieure pour la liaison à l'os crânien, sur le côté de laquelle sont formés des bras en tant que bras d'ostéosynthèse, les bras comprennent des traversées pour des vis en tant que vis d'ostéosynthèse, une plaque de base à placer par l'extérieur contre la peau du crâne de l'utilisateur, qui comprend une zone centrale et une zone périphérique s'étendant autour de la zone centrale, la plaque de base et/ou la plaque contiennent une substance magnétique, une face supérieure, de la zone centrale, opposée à la face inférieure de la zone centrale et/ou de la zone périphérique de la plaque de base est appropriée pour un couplage par conformité de forme, par frottement et/ou à force à des appareils d'aide auditive.
PCT/DE2017/000246 2016-08-01 2017-08-01 Dispositif de couplage à des appareils d'aide auditive sans inconfort pour les patients Ceased WO2018024275A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE112017003844.8T DE112017003844B4 (de) 2016-08-01 2017-08-01 Vorrichtung zur patientenschonenden Kopplung an Hörgeräten

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
DE202016004945.4U DE202016004945U1 (de) 2016-08-01 2016-08-01 Universelles Magnetimplantat für Knochenleitungshörgeräte
DE202016004945.4 2016-08-01
DE202017002813.1U DE202017002813U1 (de) 2017-05-29 2017-05-29 Elastische Folie zur Klebefixation von Knochenleitungshörgeräten
DE202017002813.1 2017-05-29
DE202017002979.0 2017-06-08
DE202017002979.0U DE202017002979U1 (de) 2017-06-08 2017-06-08 Perkutanes Magnetimplantat

Publications (1)

Publication Number Publication Date
WO2018024275A1 true WO2018024275A1 (fr) 2018-02-08

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PCT/DE2017/000246 Ceased WO2018024275A1 (fr) 2016-08-01 2017-08-01 Dispositif de couplage à des appareils d'aide auditive sans inconfort pour les patients

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Country Link
DE (1) DE112017003844B4 (fr)
WO (1) WO2018024275A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4017030A1 (fr) * 2020-12-18 2022-06-22 CADskills Dispositif de couplage d'un vibrateur de conduction osseuse
EP3962591A4 (fr) * 2019-05-02 2023-05-31 Cochlear Limited Bague d'ostéointégration pour le couplage d'un dispositif de conduction osseuse

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140121450A1 (en) * 2012-07-16 2014-05-01 Sophono, Inc. Magnetic Abutment Systems, Devices, Components and Methods for Bone Conduction Hearing Aids
US20140233765A1 (en) * 2013-02-15 2014-08-21 Marcus ANDERSSON Conformable pad bone conduction device
WO2015020753A2 (fr) * 2013-08-09 2015-02-12 Otorix Usa Inc. Système de prothèse auditive à conduction osseuse
DE202015006268U1 (de) * 2015-09-10 2015-10-21 Ralf Siegert Nicht zu versenkendes Magnetimplantat zur Fixation von K-HGs
US20150312686A1 (en) * 2014-04-29 2015-10-29 Cochlear Limited Signal conducting coupling

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140121450A1 (en) * 2012-07-16 2014-05-01 Sophono, Inc. Magnetic Abutment Systems, Devices, Components and Methods for Bone Conduction Hearing Aids
US20140233765A1 (en) * 2013-02-15 2014-08-21 Marcus ANDERSSON Conformable pad bone conduction device
WO2015020753A2 (fr) * 2013-08-09 2015-02-12 Otorix Usa Inc. Système de prothèse auditive à conduction osseuse
US20150312686A1 (en) * 2014-04-29 2015-10-29 Cochlear Limited Signal conducting coupling
DE202015006268U1 (de) * 2015-09-10 2015-10-21 Ralf Siegert Nicht zu versenkendes Magnetimplantat zur Fixation von K-HGs

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3962591A4 (fr) * 2019-05-02 2023-05-31 Cochlear Limited Bague d'ostéointégration pour le couplage d'un dispositif de conduction osseuse
EP4017030A1 (fr) * 2020-12-18 2022-06-22 CADskills Dispositif de couplage d'un vibrateur de conduction osseuse

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DE112017003844B4 (de) 2025-01-02
DE112017003844A5 (de) 2019-04-18

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