WO2013023693A1 - Système de fixation d'actionneur d'instrument auditif implantable - Google Patents

Système de fixation d'actionneur d'instrument auditif implantable Download PDF

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Publication number
WO2013023693A1
WO2013023693A1 PCT/EP2011/064159 EP2011064159W WO2013023693A1 WO 2013023693 A1 WO2013023693 A1 WO 2013023693A1 EP 2011064159 W EP2011064159 W EP 2011064159W WO 2013023693 A1 WO2013023693 A1 WO 2013023693A1
Authority
WO
WIPO (PCT)
Prior art keywords
ball
actuator
locking
socket
joint
Prior art date
Application number
PCT/EP2011/064159
Other languages
English (en)
Inventor
Stéphane KARAWA
Pierre-Yves Clair
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
Priority to PCT/EP2011/064159 priority Critical patent/WO2013023693A1/fr
Publication of WO2013023693A1 publication Critical patent/WO2013023693A1/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

Definitions

  • the present invention relates to an implantable fixation system for fixing an implantable actuator of a hearing instrument to a patient's skull, comprising a bone fixation element for being fixed at the cranial bone, an actuator holding element for carrying the actuator and a lockable joint assembly for enabling adjustment of the actuator holding element relative to the bone fixation element.
  • WO 2010/133705 A2 and WO 2010/133706 A2 relate to examples of an implantable fixation system for an electromechanical actuator of a hearing instrument for stimulating the round window, wherein a bone fixation plate has one end forming the socket of a ball-and-socket joint, the ball of which is fixedly connected to an clamp assembly comprising a tubular element for fixing the actuator housing with regard to the clamp assembly.
  • US 5,788,711 relates to a similar fixation system, wherein the ball of the lockable ball-and- socket joint is fixedly connected with a linear axle which guides a carriage connected to a tubular actuator holding element.
  • the linear axle can be actuated in order to adjust the axial position of the actuator.
  • US 2009/0306458 Al relates to a hearing instrument comprising an implantable actuator coupled to a stapes prosthesis or to the round window, wherein a ball-and-socket joint is provided which can be locked for adjusting the angle between the stapes prosthesis and a coupling rod.
  • a ball-and-socket joint is provided which can be locked for adjusting the angle between the stapes prosthesis and a coupling rod.
  • Another lockable ball-and-socket joint is provided for adjusting the position of the actuator relative to the patient's skull.
  • US 2008/0188707 Al relates to a hearing instrument comprising an implantable electromechanical actuator, wherein a ball-and-socket joint is provided between a coupling rod and an artificial incus in order to allow intra-operative adjustment of the angle between the rod and the artificial incus.
  • US 2010/0324355 Al relates to a hearing instrument comprising an implantable actuator including a motor driving a plate via a coupling element which comprises two ball-and-socket joints, with the plate acting directly on the intra-cochlear fluid.
  • US 2005/0027357 Al relates to an ossicle prosthesis comprising three ball-and-socket joints arranged in series.
  • WO 2007/001386 A2 relates to a device for stabilization of a patient's spinal column comprising two ball-and-socket joints.
  • the invention is beneficial in that, by providing the joint assembly with a first ball-and-socket joint fixedly connected to the bone fixation element and a second ball-and-socket joint fixedly connected to the actuator holding assembly, with the first and second ball and socket joint being connected to each other, the lockable joint assembly is provided with additional degrees of freedom, whereby more flexible adjustment of the actuator can be achieved and, in particular, the risk of damages to the patient's tissue during implantation can be reduced.
  • Fig. 1 is a schematic cross-sectional view of an example of a hearing instrument for being used with a fixation system according to the invention after implantation;
  • Fig. 2 is a block diagram of the hearing instrument of Fig. 1 ;
  • FIG. 3 is a perspective view of an example of a fixation system according to the invention
  • Fig. 4 is another perspective view of the fixation system of Fig. 3
  • Fig. 5 is a longitudinal sectional view of the joint assembly of the fixation system of Figs. 3 and 4;
  • Fig. 6 is a view similar to Fig. 5, however, from a different point of view, wherein an alternative locking mechanism is shown;
  • Fig. 7 is a schematic view of a fixation system according to the invention for a round window actuator; and.
  • Fig. 8 is a perspective view of an example of a fixation system of the type shown in Fig. 7.
  • 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 hearing instrument 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 lead assembly 16, to an electromechanical actuator 20 for stimulating a middle ear or inner ear component of the hearing of the patient, such as an ossicle, the stapes footplate, the oval window or the round window of the cochlea 26 via a coupling rod 22 (in the example shown in Fig. 1 , the rod 22 is coupled to the stapes footplate 24 via a coupling element 23 provided at the distal end of the coupling rod 22).
  • the actuator 20 is kept in place by a fixation system 18 fixed at the patient's temporal bone 17.
  • 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 antemias 54, 58 in order to optimize both the audio signal link 40 and the power link 56.
  • the antennas 38 and 54 and the antennas 42 and 58 could be physically formed by a single antenna, respectively.
  • the fixation system 18 comprises a bone fixation element 62, a joint assembly 64 and an actuator holding assembly 66 connected via the joint assembly 64 to the bone fixation element 62.
  • the bone fixation element 62 comprises, at one end, a flange portion 68 provided with holes 70 for receiving bone screws.
  • the joint assembly 64 comprises a first ball 72, a second ball 74, a spacer element 76 located between the balls 72, 74 in contact with the balls 72, 74, a common socket 78 comprising a first part 80 engaging with the first ball 72 and a second part 84 engaging with the second ball 74 and connected with the first part 80, for example, via a snap-in connection, a locking screw 84 and an elastic blade 86 for securing the screw 84.
  • the first ball 72 is fixedly connected to the bone fixation element 62, whereas the second ball 74 is fixedly connected to the actuator holding assembly 66.
  • the joint assembly 64 thus forms an integrated double ball and socket joint comprising a first ball-and-socket joint comprising the first ball 72 and the first socket part 80 and a second ball- and-socket joint formed by the second ball 74 and the second socket part 82, with the first socket part 80 and the socket part 82 forming the common socket 78.
  • the first socket part 80 is provided with a recess 81 for enabling movement of the portion connecting the first ball 72 to the bone fixation element 62.
  • second socket part 82 is provided with a recess 83 for enabling movement of the portion connecting the second ball 74 to the actuator holding assembly 66.
  • the locking screw 84 can be actuated by the surgeon by means of a screw driver (not shown) by turning the screw 84 in order to lock both the first ball 72 and the second ball 74 by forcing the first ball 72 towards the spacer element 76 which, in turn, thereby is forced against the second ball 74 which is thereby forced towards the wall of the second socket part 82 (the force created by turning the screw 84 is illustrated in Fig. 5 by an arrow 90).
  • the balls 72 and 74 are forced towards each other by actuating the locking screw 84, which thus forms a common locking element for both balls 72 and 74.
  • the axial direction of the locking screw 84 is coaxial with an imaginary line connecting the centers of the two balls 72 and 74.
  • the balls 72 and 74 may touch each other.
  • the actuator holding assembly 66 comprises a tubular clamp element 92 for receiving the actuator 20, which may be locked / unlocked, i.e. closed / opened via a clamp mechanism 94 which may comprises, for example, some wedge-like mechanism (not shown) which may be actuated via a screw 88 (an example of such clamp mechanism 94 is found in WO 2006/058367 Al).
  • a clamp mechanism 94 which may comprises, for example, some wedge-like mechanism (not shown) which may be actuated via a screw 88 (an example of such clamp mechanism 94 is found in WO 2006/058367 Al).
  • the clamp element 92 serves to lock the actuator 20 with regard to the actuator holding assembly 66.
  • the bone fixation element 62 is fixed at the patient's temporal bone 17 via bone screws. Thereafter the desired final position of the actuator holding assembly 66 may be approached by the surgeon by manually adjusting the position of the actuator holding assembly 66 relative to the bone fixation element 62 via the joint assembly 64, whereby the degrees of freedom provided by the balls 72, 74 with regard to the common socket 78 are utilized. Once the desired position has been reached, the joint assembly 64 is locked by actuating the locking screw 84 accordingly in order to lock the balls 72 and 74 with regard to the common socket 78.
  • the axial position of the actuator 20 with regard to the actuator holding assembly 66 is then adjusted by forwarding the actuator through the clamp element 92 until the desired final position of the actuator 20 is reached, whereupon the screw 88 of the actuator holding assembly 66 is tightened by the surgeon in order to lock the clamp 92 element.
  • the locking position of the locking screw 84 of the joint assembly 64 may be secured by engaging the locking blade 86 with a slot 98 of the head 87 of the locking screw 84, with the locking blade 86 also engaging with an outer structure of the common socket 78 which, for example, may be formed by a slot.
  • the head 87 of the locking screw 84 may be provided with locking teeth 85 at the lower side of the head 87 (such locking screws are available, for example, under the trademark "Tensilock”).
  • An example of a teethed screwhead 87 not requiring a locking blade is shown in Fig. 6.
  • Figs. 7 and 8 an alternative embodiment is shown, wherein the second ball 74 of the joint assembly 164 is fixedly connected to a bent rod 102, the other end of which carries an actuator 120 for stimulation of the round window membrane 25.
  • the round window membrane can be vibrated by the actuator 120 in a direction essentially perpendicular to the round window membrane 25.
  • An example of a round window actuator carried by a bent rod is described in WO 2011/029960 A2.
  • Fig. 7 also the facial nerve 104 and the chorda tympany 106 are shown.
  • the joint assembly 164 of Figs. 7 and 8 comprises a locking mechanism 184 for locking at least the second ball 74 once the desired final position of the actuator 120 has been reached.
  • the first ball 72 may be provided with a separate locking mechanism (shown in Fig. 8 as a locking screw 185 acting on a clamp-like socket part 186 holding the ball 72); alternatively, the locking mechanism 184 may be designed to also act on the first ball 72.
  • the locking mechanism of the second ball 74 comprises a locking screw 184 acting on a a clamp-like socket part 183 holding the ball 74.
  • the fiaxtion system of the present invention may be used with all types of implantable electromechanical actuators which may be coupled, for example, to the round window, to an ossicle, to a stapes prosthesis or to an artificial hole provided in the cochlear wall.

Landscapes

  • 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)

Abstract

L'invention concerne un système de fixation implantable pour fixer un actionneur implantable (20, 120) d'un instrument auditif (10, 12, 20) au crâne d'un patient, comprenant un élément de fixation d'os (62) destiné à être fixé au niveau de l'os temporal (17) du patient, un ensemble de maintien d'actionneur (66, 166) pour porter l'actionneur, et un ensemble joint verrouillable (64, 164) pour permettre l'ajustement de l'ensemble de maintien d'actionneur par rapport à l'élément de fixation d'os, l'ensemble joint comprenant un premier joint à rotule (72, 80) relié de manière fixe à l'élément de fixation d'os et un second joint à rotule (74, 82) relié de manière fixe à l'ensemble de maintien d'actionneur, et les premier et second joints à rotule étant reliés l'un à l'autre.
PCT/EP2011/064159 2011-08-17 2011-08-17 Système de fixation d'actionneur d'instrument auditif implantable WO2013023693A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2011/064159 WO2013023693A1 (fr) 2011-08-17 2011-08-17 Système de fixation d'actionneur d'instrument auditif implantable

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2011/064159 WO2013023693A1 (fr) 2011-08-17 2011-08-17 Système de fixation d'actionneur d'instrument auditif implantable

Publications (1)

Publication Number Publication Date
WO2013023693A1 true WO2013023693A1 (fr) 2013-02-21

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PCT/EP2011/064159 WO2013023693A1 (fr) 2011-08-17 2011-08-17 Système de fixation d'actionneur d'instrument auditif implantable

Country Status (1)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210051426A1 (en) * 2014-08-28 2021-02-18 Cochlear Limited Systems for accommodating separation of body parts in auditory prostheses

Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4601723A (en) * 1985-01-29 1986-07-22 Mcgrew Robert N Telescoping self-adjusting ossicular prostheses
US5788711A (en) 1996-05-10 1998-08-04 Implex Gmgh Spezialhorgerate Implantable positioning and fixing system for actuator and sensor implants
WO1999007311A1 (fr) * 1997-08-07 1999-02-18 St. Croix Medical, Inc. Support pour transducteur de prothese auditive
US20050027357A1 (en) 2003-07-10 2005-02-03 Uwe Steinhardt Auditory ossicles prosthesis with ball-and-socket joint
WO2006058367A1 (fr) 2004-11-30 2006-06-08 Cochlear Acoustics Ltd. Ensemble fixation implantable pour mise en place amovible d'un dispositif medical
DE102005010705B3 (de) * 2005-03-09 2006-08-03 Heinz Kurz Gmbh Medizintechnik Gehörknöchelchenprothese
WO2007001386A2 (fr) 2005-06-21 2007-01-04 Depuy Spine, Inc. Methodes et dispositifs de stabilisation posterieure
US20080188707A1 (en) 2004-11-30 2008-08-07 Hans Bernard Implantable Actuator For Hearing Aid Applications
US20090306458A1 (en) 2008-03-31 2009-12-10 Cochlear Limited Direct acoustic cochlear stimulator for round window access
WO2010133706A2 (fr) 2010-09-27 2010-11-25 Advanced Bionics Ag Appareil auditif pour stimulation de fenêtre ronde ou ovale
WO2010133705A2 (fr) 2010-09-27 2010-11-25 Advanced Bionics Ag Instrument auditif pour une stimulation de la fenêtre ronde
US20100324355A1 (en) 2006-12-26 2010-12-23 3Win N.V. Device and method for improving hearing
WO2011029960A2 (fr) 2011-01-04 2011-03-17 Advanced Bionics Ag Instrument auditif pour stimulation de la fenêtre ronde

Patent Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4601723A (en) * 1985-01-29 1986-07-22 Mcgrew Robert N Telescoping self-adjusting ossicular prostheses
US5788711A (en) 1996-05-10 1998-08-04 Implex Gmgh Spezialhorgerate Implantable positioning and fixing system for actuator and sensor implants
WO1999007311A1 (fr) * 1997-08-07 1999-02-18 St. Croix Medical, Inc. Support pour transducteur de prothese auditive
US20050027357A1 (en) 2003-07-10 2005-02-03 Uwe Steinhardt Auditory ossicles prosthesis with ball-and-socket joint
US20080188707A1 (en) 2004-11-30 2008-08-07 Hans Bernard Implantable Actuator For Hearing Aid Applications
WO2006058367A1 (fr) 2004-11-30 2006-06-08 Cochlear Acoustics Ltd. Ensemble fixation implantable pour mise en place amovible d'un dispositif medical
DE102005010705B3 (de) * 2005-03-09 2006-08-03 Heinz Kurz Gmbh Medizintechnik Gehörknöchelchenprothese
WO2007001386A2 (fr) 2005-06-21 2007-01-04 Depuy Spine, Inc. Methodes et dispositifs de stabilisation posterieure
US20100324355A1 (en) 2006-12-26 2010-12-23 3Win N.V. Device and method for improving hearing
US20090306458A1 (en) 2008-03-31 2009-12-10 Cochlear Limited Direct acoustic cochlear stimulator for round window access
WO2010133706A2 (fr) 2010-09-27 2010-11-25 Advanced Bionics Ag Appareil auditif pour stimulation de fenêtre ronde ou ovale
WO2010133705A2 (fr) 2010-09-27 2010-11-25 Advanced Bionics Ag Instrument auditif pour une stimulation de la fenêtre ronde
WO2011029960A2 (fr) 2011-01-04 2011-03-17 Advanced Bionics Ag Instrument auditif pour stimulation de la fenêtre ronde

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210051426A1 (en) * 2014-08-28 2021-02-18 Cochlear Limited Systems for accommodating separation of body parts in auditory prostheses

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