WO2012041400A1 - Instrument d'audition servant à stimuler la fenêtre ronde ou la fenêtre ovale - Google Patents

Instrument d'audition servant à stimuler la fenêtre ronde ou la fenêtre ovale Download PDF

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Publication number
WO2012041400A1
WO2012041400A1 PCT/EP2010/066184 EP2010066184W WO2012041400A1 WO 2012041400 A1 WO2012041400 A1 WO 2012041400A1 EP 2010066184 W EP2010066184 W EP 2010066184W WO 2012041400 A1 WO2012041400 A1 WO 2012041400A1
Authority
WO
WIPO (PCT)
Prior art keywords
hearing instrument
support member
end portion
actuator
lever element
Prior art date
Application number
PCT/EP2010/066184
Other languages
English (en)
Inventor
Pierre-Yves Clair
Christian Imbert
Jean-Claude Lanz
Ranjeeta Ambett
Original Assignee
Advanced Bionics Ag
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Advanced Bionics Ag filed Critical Advanced Bionics Ag
Publication of WO2012041400A1 publication Critical patent/WO2012041400A1/fr

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Classifications

    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
    • 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; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R2225/00—Details of deaf aids covered by H04R25/00, not provided for in any of its subgroups
    • H04R2225/67—Implantable hearing aids or parts thereof not covered by H04R25/606

Definitions

  • the present invention relates to a hearing instrument comprising an audio signal source (typically a microphone arrangement), an audio signal processing unit for processing the audio signals provided by the audio signal source and an implantable assembly for stimulation of the round window or oval window of the cochlea according to the processed audio signals.
  • an audio signal source typically a microphone arrangement
  • an audio signal processing unit for processing the audio signals provided by the audio signal source
  • an implantable assembly for stimulation of the round window or oval window of the cochlea according to the processed audio signals.
  • the cochlea provides a second natural window for mechanical stimulation, namely the round window.
  • the round window is closed by a compliant membrane and, besides other purposes, may serve for compensation of static pressures on the inner ear.
  • Mechanical stimulation of the round window membrane is an approach particularly suitable in cases where normal middle ear structures are absent or are severely damaged and cannot be used.
  • US 2009/0306458 Al relates to a partially implantable hearing aid comprising an electromechanical actuator acting via a coupling element on the round window.
  • the coupling element may have an angled configuration, and it may include a ball and socket joint which can be locked in order to adjust the angle formed by the coupling element.
  • WO 2009/062172 A2 relates to a fully implantable hearing aid comprising an electromechanical actuator acting via a coupling element on the round window.
  • the coupling element comprises a first rod being driven by the actuator in reciprocating manner, a second rod being fixedly connected to a stationary portion of the middle ear anatomy and a third rod touching the round window, with the three rods being connected to each other in a star-like fashion at a central joint which may be a mechanical joint, such as a hinge, or a flexible joint, such as an elastomeric member.
  • the first and the third rod thereby are angled with regard to each other.
  • US 7,753,838 B2 relates to an implantable stimulation assembly which has a rod-like vibratory member which is driven to a reciprocating motion by a first electromagnetic driver acting on the proximal end of the vibratory member and which is driven by a second electromagnetic driver to a tilting/pivoting motion in a direction normal to the axial direction of the vibratory member, with the tip member of the vibratory member being coupled to an ossicle.
  • the vibratory member is driven at its proximal end by a motor, with a pivotal section, which is connected via a hinge member to a bellows, being provided at the distal end, and with the vibratory member comprising an eccentric rod having a distal end applyin a force to the pivotal end section at a point displaced from the hinge member.
  • a motor with a pivotal section, which is connected via a hinge member to a bellows, being provided at the distal end
  • the vibratory member comprising an eccentric rod having a distal end applyin a force to the pivotal end section at a point displaced from the hinge member.
  • the invention is beneficial in that, by providing the stimulation assembly with a lever element supported by a support member which is fixed at the patient's skull and at which also the actuator is fixed, with the actuator driving the lever element to a pivoting motion, the angle of the direction used for stimulation of the round or oval window can be adjusted relative to the direction of the output motion of the actuator, thereby achieving efficient stimulation of the round or oval window; in addition, by using such pivoting lever element for stimulation, the force applied by the lever element to the round or oval window can be adjusted.
  • Preferred embodiments of the invention are defined in the dependent claims.
  • Fig. 1 is a cross-sectional view of an example of a hearing instrument according to the invention after implantation
  • Fig. 2 is a block diagram of the system of Fig. 1 ;
  • Fig. 3 is a schematic view of an example of a stimulation assembly of a hearing instrument according to the invention.
  • Fig. 4 is a perspective view of an example of a stimulation assembly of a hearing instrument according to the invention, being shown together with the cochlea and the ossicular chain;
  • Fig. 5 is a perspective side view of an example of a stimulation assembly of a hearing instrument according to the invention.
  • Figs. 6 to 8 show a perspective view of various examples of a pivot element of the stimulation assembly of a hearing instrument according to the invention
  • Fig. 9 is a perspective view of an example of a stimulation assembly when connected to a fixation system allowing three-dimensional adjustment;
  • Fig. 10 is a perspective view of an example of a stimulation assembly of a hearing instrument according to the invention when connected to a single axis fixation system;
  • Fig. 11 is a longitudinal sectional view of the components of Fig. 10;
  • Fig. 12 is a perspective view of a modified embodiment of the components shown in
  • Fig. 13 is a schematic view of an example of a stimulation assembly comprising an angled lever element
  • Fig, 14 is a perspective view of an example of a stimulation assembly of a hearing instrument according to the invention, being shown together with the cochlea and the ossicular chain, when connected to a fixation system allowing three- dimensional adjustment;
  • Fig. 15 is a view like Fig. 3 of an alternative embodiment of the invention.
  • Fig. 1 shows a cross-sectional view of the mastoid region, the middle ear and the inner ear of a patient after implantation of an example of a hearing instrument according to the invention, wherein the hearing instrument is shown only schematically.
  • the system comprises an external unit 10 which is worn outside the patient's body at the patient's head, typically close to the ear, and an implantable unit 12 which is implanted under the patient's skin 14, usually in an artificial cavity created in the user's mastoid.
  • the implantable unit 12 is connected, via a cable assembly 16, to a stimulation assembly 18 comprising an electromechanical actuator 20 for stimulating the round window 24 of the cochlea 26 via a lever element 22.
  • the external unit 10 is fixed at the patient's skin 14 in a position opposite to the implantable unit 12, for example, by magnetic forces created between at least one fixation magnet provided in the external unit 10 and at least one co-operating fixation magnet provided in the implantable unit 12 (the magnets are not shown in Fig. 1).
  • the external unit 10 includes a microphone arrangement 28, which typically comprises at least two spaced-apart microphones 30 and 32 for capturing audio signals from ambient sound, which audio signals are supplied to an audio signal processing unit 34, wherein they undergo, for example, acoustic beam forming.
  • the processed audio signals are supplied to a transmission unit 36 connected to a transmission antenna 38 in order to enable transcutaneous transmission of the processed audio signals via an inductive link 40 to the implantable unit 12 which comprises a receiver antenna 42 connected to a receiver unit 44 for receiving the transmitted audio signals.
  • the received audio signals are supplied to a driver unit 48 which drives the actuator 20.
  • the external unit 10 also comprises a power supply 50 which may be a replaceable or rechargeable battery, a power transmission unit 52 and a power transmission antenna 54 for transmitting power to the implantable unit 12 via a wireless power link 56.
  • the implantable unit 12 comprises a power receiving antenna 58 and a power receiving unit 60 for powering the implanted electronic components with power received via the power link 56.
  • the audio signal antennas 38, 42 are separated from the power antennas 54, 58 in order to optimize both the audio signal link 40 and the power link 56.
  • the antennas 38 and 42 and the antennas 54 and 58 could be physically formed by a single antenna, respectively.
  • Fig. 3 an example of the structure of a stimulation assembly is shown schematically.
  • the stimulation assembly 18 comprises an electromechanical actuator 20 (which may be formed, for example, by electromagnetic transducer) for driving an output member formed by a rod 62 in a reciprocating manner, a lever element 22 having a first, distal end portion 64 acting on the round window membrane 24, a second, proximal end portion 66 driven by the output member 62 and an intermediate portion 68 connecting the distal end portion 64 and the proximal end portion 66 and being supported by a pivot element 70, and a support member 72 for supporting the actuator 20 via an adjustable actuator fixation portion 74 and for supporting the pivot element 70 (hereinafter, “distal” designates directions towards the round or oval window, and “proximal” designates directions away from the round or oval window towards the skin).
  • an electromechanical actuator 20 (which may be formed, for example, by electromagnetic transducer) for driving an output member formed by a rod 62 in a reciprocating manner
  • a lever element 22 having a first, distal end portion 64 acting on the round window membrane 24, a second,
  • both the pivot element 70 and the actuator 20 are fixed relative to the support member 72.
  • the free end of the output rod 62 is provided with a rounded tip 76 for touching a contact area of the proximal end portion 66 of the lever element 22, with the output rod 62 moving in a direction substantially perpendicular to the direction into which the proximal end portion 66 of the lever element 22 extends.
  • the distal end portion 64 is provided with a rounded contact element 79 extending into a radial direction of (i.e. laterally from) the distal end portion 64 and acting on the round window membrane 24.
  • the contact element 79 of the lever element 22 preferably has a mushroom-like spherical head, with the front surface area of the head being substantially equal to the area of the round window membrane 24.
  • the contact element 79 is made of or coated with a pyrocarbon material.
  • the pyrocarbon material typically has a Vickers hardness of 150 to 250.
  • the surface roughness Ra of the contact element 79 is less than 0.02 iim.
  • the support member 72 comprises a first portion 80 for holding the actuator 20 via the actuator fixation portion 74 and a second portion 82 for holding the pivot element 70, with the first portion 80 and the second portion 82 extending in directions which are essentially perpendicular with regard to each other.
  • the first portion 80 and the second portion 82 of the support member 72 have an essentially tubular, preferably cylindrical design, wherein the first portion 80 houses the actuator 20, and the second portion 82 houses the proximal end portion 66 and the intermediate portion 68 of the lever element 22
  • a stimulation assembly 18 wherein the support member 72 comprises an essentially cylindrical second portion 82 and an essentially cylindrical first portion 80 which are oriented perpendicular to each other.
  • the position of the actuator 20 relative to the support member 72 is axially adjustable with regard to the actuation direction (i.e. the direction of the reciprocating movement) of the output rod 62 in order to adjust the loading of the contact element 79 of the distal end portion 64 of the lever element 22 on the round window membrane 24.
  • This may be realized, as shown in Figs. 5 and 9 to 12, by a rotatable adjustment member 84 engaging with a thread provided at the first portion 80 of the support member 72.
  • a rotatable adjustment member 84 engaging with a thread provided at the first portion 80 of the support member 72.
  • the adjustment member 84 is a nut-like element which is screwed onto an outer thread 86 provided at the periphery of the first portion 80 of the support element 72.
  • the outer surface of the actuator 20 preferably is provided with a structure engaging with a mating counter-structure provided at the actuator fixation portion 74 of the support member 72 in manner that the actuator is axially moveable in the actuation direction of the output member 62, but is prevented from rotation.
  • Such engagement may be provided in a rib-and- groove fashion, for example by providing the outer surface o the actuator 20 with an axially extending rib and providing the inner surface of the actuator fixation portion with a corresponding groove for receiving the rib.
  • the nut-like element 84 is provided with an axially extending lateral slot 85 (see Fig. 9) for allowing the cable assembly 16 connecting the actuator 20 to the implantable unit 12 to pass into a central portion of the the nut-like element 84.
  • the pivot element 70 is constructed in a manner so as to have a torsion f the central portion 90 due to the pivoting motion of the lever element 22, while avoiding friction on materials in order to keep wearing of the materials small.
  • the pivot element 70 may be designed in a hub-like manner to be torsioned by the pivoting motion of the lever element 22, with the pivot element 70 being made of a sufficiently elastic material.
  • the pivot element 70 comprises two end portions 88 which are fixed at the support member 72 and a central portion 90 which extends between the end portions 88 and at which the intermediate portion 68 of the lever element 22 is fixed.
  • the end portions 88 of the pivot element 70 are fixed in corresponding holes in the wall of the second portion 82 of the support member 72.
  • the central portion 90 of the pivot element 70 comprises a central opening 92 in which the intermediate portion 68 of the lever element 22 is fixed.
  • the pivot element 70 may be made of silicone, with the central portion 90 of the pivot element 70 having a rod-like shape.
  • the central portion is made of a suitable metal material and has a wireless design.
  • the central portion 90 of the pivot element 70 has a blade-like shape.
  • the lever element 22 is substantially straight.
  • the distal end portion 64 and the proximal end portion 66 of the lever element 22 may be angled with regard to each other, thereby introducing an additional design parameter, namely the angle between the portions 64 and 66, which can be adjusted for achieving optimal coupling to the round window membrane 24 (when using a straight lever, the movement of the output rod 62 of the actuator 20 is anti- parallel to the movement of the contact element 79 of the lever element 22; by selecting an appropriate angled configuration of the lever element 22, the angle between the movement of the output rod 62 and the movement of the contact element 79 can be adjusted as desired).
  • a schematic example of a stimulation assembly using such a angled lever element 22 is shown in Fig. 13.
  • the support member 72 preferably is made of titanium .
  • the support member 72 is fixed at the patient's skull via an adjustable fixation system 94 by bone screws (in Figs.4 and 9-12 only the bone screw openings 96 of the fixation system 94 are shown, but not the bone screws themselves).
  • the fixation system 94 comprises a linearly driven slide element 92, at which the support member 72 is fixed, and a lockable ball joint 100 at which the slide element 92 is supported.
  • the ball joint 100 forms part of a flange element 102 comprising the bone screw opening 96.
  • the slide element 92 is replaced by a clamp element 105 which is attached to the ball of the ball joint 100 and which comprises two legs 103, 106 for surrounding a cyclindrical proximal portion 108 of the support member 72 in manner so as to connect the support member 72 to fixation system 94 in an adjustable manner.
  • the legs 103, 106 are connected at one end by a screw 109 which can be turned by the surgeon so as to adjust the clamping force exerted by the legs 103, 106 onto the proximal portion 108 of the support member 72.
  • the support member 72 When the screw 109 is loosened, the support member 72 may be axially moved and/or rotated relative to the clamp element 105 in order to adjust the position ond orientation of the support member 72 relative to the fixation system 94, thereby also adjusting the position of the contact element 79 with regard to the cochlea 26. B tightening the screw 109, the support member 72 can be fixed with regard to the fixation system 94.
  • FIG. 10 and 1 An alternative embodiment of a fixation system fixation system 194 is shown in Figs. 10 and 1 1.
  • the second portion 82 of the support element 72 carries a stopper plate 104 which is adjustable in the axial direction with regard to the support member 72 in order to determine the position of the support member 72 during implantation.
  • the cylindrical second portion 82 of the support member 72 is provided with an outer thread 106, with the stopper plate 104 having a central openin provided with an inner thread 108 engaging with the outer thread 106. Thereby the axial position of the stopper plate 104 can be adjusted by rotating the stopper plate 104.
  • the support member 72 comprises a third portion 1 10 which forms an axial extension of the second portion 82 beyond the region where the first portion 80 and the second portion 82 are connected to each other.
  • a fixation plate 1 12 comprising bone screw openings 96 for being fixed at the patient's skull is connected to the third portion 1 10 of the support member 72 in a manner so as to be axially movable but not rotatable with regard to the third portion 1 10.
  • the fixation plate 1 12 comprises a base portion 1 14 which is slidably received in a receptacle 1 16 in the third portion 1 10 of the support member 72.
  • the base portion 114 and the receptacle 1 16 have a none-circular symmetry, for example, by providing axial grooves engaging with corresponding projections.
  • the fixation system 194 shown in Figs. 10 and 1 1 allows for adjustment of the position of the stimulation assembly 18 in one direction only, namely along the axial direction of the second portion 82 of the support member 72. Such linear adjustment is achieved by adjusting the axial position of the stopper plate 104 by rotating the stopper plate 104 accordingly.
  • Such design of the fixation system is much simpler than that of Fig. 9. However, it requires a much more precise drilling of the cavity into which the stimulation assembly 18 is to be inserted.
  • An appropriate drilling/implantation method is described in WO 2010/061006 A2 and international application No. PCT/EP2010/056749.
  • the axial position of the stopper plate 104 is adjusted prior to inserting the stimulation assembly into the drilled cavity by using a fork-shaped tool (not shown) engaging with radially extending openings 105 of the stopper plate 104, with the support member 72 being held by hand. After the stimulation assembly 18 has been inserted into the cavity, the stopper plate 104 is fixed to the bone.
  • Fig. 12 a modification of the embodiment of Figs. 10 and 1 1 is shown, wherein the fixation plate 1 12 includes a compartment 118 for electronic components, whereby the electronic components can be brought close to the main axis of the stimulation assembly 18.
  • the actuator 20 comprises a coil 63 which drives the output member 162 which is designed as the core of the coil 63, with the output member 162 forming the proximal end of the proximal end portion 66 and with the output member 162 - and the coil 63 - extending substantially perpendicular to the axial direction of the proximal end portion 66.
  • the proximal end portion 66 has a T-shaped configuration, wherein the coil 63 is provided with a radial opening through which the output member 162 is connected to the remainder of the proximal end portion 66.
  • the proximal end portion 66 may have an T-shaped configuration, wherein the output member 162 axially extending through the coil 63 is connected to the remainder of the proximal end portion 66 at a position close of the axial ends of the coil 63; in this case the coil 63 does not have a radial opening 65. While the examples described so far relate to stimulation of the round window, it is to be understood that the above examples of the stimulation assembly 18 in principle also could be used for stimulation of the oval window.

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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)
  • Prostheses (AREA)
  • Electrotherapy Devices (AREA)

Abstract

Cette invention concerne un instrument d'audition comprenant une source de signaux audio (28), une unité de traitement des signaux audio (34) qui traite les signaux audio émis par la source de signaux audio, et un ensemble de stimulation implantable (18) qui stimule la fenêtre ronde (24) ou la fenêtre ovale du patient en fonction des signaux audio traités. L'ensemble de stimulation comprend un organe de commande électromécanique (20) qui fait vibrer un organe de sortie (62, 162) en fonction des signaux audio traités, un support (72) fixé au crâne du patient, et un levier (22) doté d'une partie d'extrémité proximale (66), d'une partie d'extrémité distale (64) et d'une partie intermédiaire (68) reliant la partie d'extrémité proximale et la partie d'extrémité distale. L'organe de commande est fixé au support, la portion intermédiaire étant soutenue par le support de manière à permettre un mouvement de rotation du levier. L'organe de sortie est conçu pour conférer un mouvement de rotation au levier en agissant sur la partie proximale, la partie d'extrémité distale étant conçue pour agir sur la fenêtre ronde ou la fenêtre ovale afin de faire vibrer la membrane (24) de la fenêtre ronde ou de la fenêtre ovale en fonction du mouvement de rotation du levier.
PCT/EP2010/066184 2010-09-27 2010-10-26 Instrument d'audition servant à stimuler la fenêtre ronde ou la fenêtre ovale WO2012041400A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/EP2010/064287 WO2010133706A2 (fr) 2010-09-27 2010-09-27 Appareil auditif pour stimulation de fenêtre ronde ou ovale
EPPCT/EP2010/064287 2010-09-27

Publications (1)

Publication Number Publication Date
WO2012041400A1 true WO2012041400A1 (fr) 2012-04-05

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Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/EP2010/064287 WO2010133706A2 (fr) 2010-09-27 2010-09-27 Appareil auditif pour stimulation de fenêtre ronde ou ovale
PCT/EP2010/066184 WO2012041400A1 (fr) 2010-09-27 2010-10-26 Instrument d'audition servant à stimuler la fenêtre ronde ou la fenêtre ovale

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/064287 WO2010133706A2 (fr) 2010-09-27 2010-09-27 Appareil auditif pour stimulation de fenêtre ronde ou ovale

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WO (2) WO2010133706A2 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013017173A1 (fr) * 2011-08-03 2013-02-07 Advanced Bionics Ag Actuateur implantable d'une prothèse auditive
WO2013023693A1 (fr) 2011-08-17 2013-02-21 Advanced Bionics Ag Système de fixation d'actionneur d'instrument auditif implantable
PL443710A1 (pl) * 2023-02-08 2024-04-22 Politechnika Warszawska Dokostny implant słuchowy

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6491622B1 (en) * 2000-05-30 2002-12-10 Otologics Llc Apparatus and method for positioning implantable hearing aid device
US20080293998A1 (en) * 2007-05-24 2008-11-27 Travis Rian Andrews Lateral coupling of an implantable hearing aid actuator to an auditory component
WO2009062172A2 (fr) 2007-11-08 2009-05-14 Otologics, Llc Connecteur traversant pour prothèse auditive implantable
US20090306458A1 (en) 2008-03-31 2009-12-10 Cochlear Limited Direct acoustic cochlear stimulator for round window access
WO2010061006A2 (fr) 2010-02-23 2010-06-03 Phonak Ag Gabarit de perçage personnalisé pour l'implantation d'une prothèse auditive
US7753838B2 (en) 2005-10-06 2010-07-13 Otologics, Llc Implantable transducer with transverse force application

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6491622B1 (en) * 2000-05-30 2002-12-10 Otologics Llc Apparatus and method for positioning implantable hearing aid device
US7753838B2 (en) 2005-10-06 2010-07-13 Otologics, Llc Implantable transducer with transverse force application
US20080293998A1 (en) * 2007-05-24 2008-11-27 Travis Rian Andrews Lateral coupling of an implantable hearing aid actuator to an auditory component
WO2009062172A2 (fr) 2007-11-08 2009-05-14 Otologics, Llc Connecteur traversant pour prothèse auditive implantable
US20090124849A1 (en) * 2007-11-08 2009-05-14 Nicholas Pergola Spanning connector for implantable hearing instrument
US20090306458A1 (en) 2008-03-31 2009-12-10 Cochlear Limited Direct acoustic cochlear stimulator for round window access
WO2010061006A2 (fr) 2010-02-23 2010-06-03 Phonak Ag Gabarit de perçage personnalisé pour l'implantation d'une prothèse auditive

Also Published As

Publication number Publication date
WO2010133706A3 (fr) 2011-06-30
WO2010133706A2 (fr) 2010-11-25

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