(19)
(11)EP 3 203 951 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
29.04.2020 Bulletin 2020/18

(21)Application number: 15849754.5

(22)Date of filing:  05.10.2015
(51)International Patent Classification (IPC): 
A61F 11/04(2006.01)
A61N 1/36(2006.01)
(86)International application number:
PCT/US2015/053916
(87)International publication number:
WO 2016/057357 (14.04.2016 Gazette  2016/15)

(54)

TEMPLATE FOR BILATERAL SYMMETRIC STIMULATOR FIXATION/IMPLANTATION

SCHABLONE ZUR BILATERALEN SYMMETRISCHEN STIMULATORFIXIERUNG/-IMPLANTATION

GABARIT POUR FIXATION/IMPLANTATION DE STIMULATEUR SYMÉTRIQUE BILATÉRAL


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 06.10.2014 US 201462060042 P

(43)Date of publication of application:
16.08.2017 Bulletin 2017/33

(73)Proprietor: Med-El Elektromedizinische Geraete GmbH
6020 Innsbruck (AT)

(72)Inventors:
  • DHANASINGH, Anandhan
    600094 Chennai (IN)
  • JOLLY, Claude
    A-6020 Innsbruck (AT)
  • HARNISCH, Andreas
    6020 Innsbruck (AT)

(74)Representative: Downing, Michael Philip 
Downing IP Limited Grosvenor House
7 Horseshoe Crescent Beaconsfield, Bucks. HP9 1LJ
7 Horseshoe Crescent Beaconsfield, Bucks. HP9 1LJ (GB)


(56)References cited: : 
WO-A1-2009/132389
US-A1- 2003 199 886
US-A1- 2008 262 468
US-A1- 2014 107 400
WO-A1-2009/132389
US-A1- 2003 199 886
US-A1- 2012 179 187
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    FIELD OF THE INVENTION



    [0001] The present invention relates to hearing implant systems, and more specifically to surgical templates for implantation of bilateral hearing implant systems.

    BACKGROUND ART



    [0002] A normal human ear transmits sounds as shown in Figure 1 through the outer ear 101 to the tympanic membrane 102 which moves the bones of the middle ear 103 that vibrate the oval window and round window openings of the cochlea 104. The cochlea 104 is a long narrow duct wound spirally about its axis for approximately two and a half turns. It includes an upper channel known as the scala vestibuli and a lower channel known as the scala tympani, which are connected by the cochlear duct. The cochlea 104 forms an upright spiraling cone with a center called the modiolar where the spiral ganglion cells of the acoustic nerve 113 reside. In response to received sounds transmitted by the middle ear 103, the fluid-filled cochlea 104 functions as a transducer to generate electric pulses which are transmitted to the cochlear nerve 113, and ultimately to the brain.

    [0003] Hearing is impaired when there are problems in the ability to transduce external sounds into meaningful action potentials along the neural substrate of the cochlea 104. To improve impaired hearing, auditory prostheses have been developed. For example, when the impairment is related to operation of the middle ear 103, a conventional hearing aid may be used to provide acoustic-mechanical stimulation to the auditory system in the form of amplified sound. Or when the impairment is associated with the cochlea 104, a cochlear implant with an implanted electrode can electrically stimulate auditory nerve tissue with small currents delivered by multiple electrode contacts distributed along the electrode. Although the following discussion is specific to cochlear implants, some hearing impaired persons are better served when the stimulation electrode is implanted in other anatomical structures. Thus hearing implant systems include brainstem implants, middle brain implants, etc. each stimulating a specific auditory target in the hearing system.

    [0004] Figure 1 also shows some components of a typical cochlear implant system where an external microphone provides an audio signal input to an external behind the ear (BTE) processor 111 in which various signal processing schemes can be implemented. The processed signal is then converted into a digital data format for transmission by external transmitter coil 107 into the implant stimulator 108. Besides receiving the processed audio information, the implant stimulator 108 also performs additional signal processing such as error correction, pulse formation, etc., and produces a stimulation pattern (based on the extracted audio information) that is sent through an electrode lead 109 to an implanted electrode array 110. Typically, this electrode array 110 includes multiple electrode contacts 112 on its surface that provide selective electrical stimulation of the cochlea 104.

    [0005] Bilateral cochlear implant systems provide cochlear implants to both the left and right ears. Normally two sequential implantation surgeries are performed. The first surgery is performed on one side, and the second surgery is then performed some time later, sometimes years after the first implantation surgery, and even different surgeons may perform the separate surgeries. During the first implantation surgery, no data is documented on the exact position (e.g. regarding implantation angle) that can be used for the second side.

    [0006] During both surgeries, the fixation position of implant stimulator is very important. The length of the connecting cable from the BTE processor to the external transmitter coil very much depends on the position of the implant stimulator. And in a bilateral implant system with a single external processor, the sound received by the processor from both sides should be symmetrical, otherwise there could be undesired inter aural time differences.

    [0007] WO2009/132389A1 discloses a method using a gauging tool 40, which takes the form of an elongate band extending around the upper portion of a patient's head from the ear canals.

    [0008] US2003199886 discloses a localizing apparatus includes a frame, a linear reference marker, and a target marker. The frame includes a first portion fixable to a first anatomical reference point. The linear reference marker is rotatable about the first anatomical reference point to align a second anatomical reference point with the first anatomical reference point. The target marker is rotatable about the first anatomical reference point to establish an angle from the linear reference marker such that the target marker is located in a desired plane.

    SUMMARY OF THE INVENTION



    [0009] Embodiments of the present invention are directed to surgical template arrangements for a bilateral hearing implant system. An adjustable headpiece with left and right sides is configured to fit over the head of a surgical patient. There are left and right implant stimulator templates, each connected to a corresponding left and right side of the adjustable headpiece by an adjustable connection and configured to conform against an underlying side of the patient's head. Each implant stimulator template has an implant outline defining an area corresponding to an implanted stimulator of the bilateral hearing implant system. Each adjustable connection is configured to allow adjustment of the position of the implant stimulator template with respect to the adjustable headpiece so as to define stimulator implantation sites at symmetric locations on each side of the patient's head.

    [0010] Each adjustable connection may be configured to enable the corresponding implant stimulator template to adjustably pivot through an adjustment angle with respect to the adjustable headpiece. Specifically, each adjustable connection may be configured to allow adjustable pivoting through a limited range of recommended adjustment angles. And/or there may be an angle indicator scale configured to provide a visual indication of the adjustment angle and/or a holding magnet located within the outer outline of one of the implant stimulator templates configured to hold that implant stimulator template securely on the skin over an implanted magnet of a previously implanted stimulator to allow determination of the adjustment angle.

    [0011] Each implant stimulator template may include marking openings configured for location marking on the underlying tissue during implantation surgery. At least one template may be made of malleable plate metal and/or at least one template may be made of resilient polymer material.

    [0012] In some embodiments, there may also be at least one behind the ear (BTE) processor template located on the adjustable headpiece at one of the adjustable connections. The at least one BTE processor template has a processor outline defining an area corresponding to an external BTE processor device of the bilateral hearing implant system, and the at least one BTE processor template is configured to fit behind the ear pinna of the recipient patient in a post-surgical operational position and conform against an underlying side of the patient's head. In some embodiments, there may be a pair of left and right side BTE templates, one on each side of the adjustable headpiece at the adjustable connection for the corresponding left and right side implant stimulator templates.

    [0013] Embodiments of the present invention also include surgical template arrangements for a bilateral hearing implant system without an adjustable headpiece. An implant stimulator template is configured to fit behind an outer ear pinna of a recipient patient at an adjustable connection and is configured to conform against an underlying side of the head. The implant stimulator template has an implant outline defining an area corresponding to an implanted stimulator of the bilateral hearing implant system. The adjustable connection is configured to allow adjustment of the position of the implant stimulator template with respect to the outer ear pinna so as to define stimulator implantation sites at symmetric locations on each side of the patient's head. An embodiment may also include a behind the ear (BTE) processor template having a processor outline defining an area corresponding to an external BTE processor device of the bilateral hearing implant system, and configured to fit behind the ear pinna of the recipient patient at the adjustable connection with the implant stimulator template, and configured to conform against an underlying side of the patient's head.

    [0014] The adjustable connection may be configured to enable the implant stimulator template to adjustably pivot through an adjustment angle with respect to the outer ear pinna. For example, the adjustable connection may be configured to allow adjustable pivoting through a limited range of recommended adjustment angles, and/or there may be an angle indicator scale configured to provide a visual indication of the adjustment angle, and/or there may be a holding magnet located within the outer outline of the implant stimulator templates configured to hold the implant stimulator template securely on the skin over an implanted magnet of a previously implanted stimulator to allow determination of the adjustment angle.

    [0015] The implant stimulator template may include marking openings configured for location marking on the underlying tissue during implantation surgery. The implant stimulator template may be made of malleable plate metal and/or at least one template may be made of resilient polymer material.

    BRIEF DESCRIPTION OF THE DRAWINGS



    [0016] 

    Figure 1 shows a section view of a human ear with a typical auditory prosthesis system designed to deliver electric stimuli to the inner ear.

    Figure 2A-2B shows an embodiment of a symmetric surgical template arrangement for implantation of bilateral hearing implant systems based on an adjustable headpiece.

    Figure 3 shows another embodiment of a symmetric surgical template arrangement for implantation of bilateral hearing implant systems without a headpiece.

    Figure 4 shows another embodiment of a symmetric surgical template arrangement for implantation of bilateral hearing implant systems without a headpiece.


    DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS



    [0017] Embodiments of the present invention are directed to surgical template arrangements for symmetric implantation of bilateral hearing implant systems. These are used before and/or during implantation surgery to help the surgeon to locate the implant stimulator device in symmetrical locations on both sides of the temporal bone. Such template arrangements can also be used for surgeries that require a special angle between the implant stimulator and the external BTE processor. By establishing controlled symmetric implantation sites for a bilateral hearing system, such embodiments promote optimal hearing in such systems including sound direction perception. Symmetric implantation sites are also preferred for aesthetic reasons.

    [0018] Figure 2A-2B shows an embodiment of a symmetric surgical template arrangement for bilateral hearing implant systems that uses an adjustable headpiece 203. The adjustable headpiece 203 has left and right sides 204 and 205 respectively which are configured to fit over the patient's head 201. During implantation surgery, the headpiece 203 is first fixed to the patient's head 201 and adjusted to the size of the patient's head 201 (adults vs. children).

    [0019] On each side of the adjustable headpiece 203 there are left and right behind the ear (BTE) processor templates 205 that are configured to fit behind the ear pinna 202 of the patient's head 201. Each BTE processor template 205 is adapted to conform against an underlying side of the patient's head 201, and has a processor outline 207 that defines an area corresponding to an external BTE processor device of the bilateral hearing implant system in a post-surgical operational position. There also are left and right implant stimulator templates 208, each connected to a corresponding BTE processor template 206 by an adjustable connection 209. The implant stimulator templates 208 also are configured to conform against an underlying side of the patient's head 201. Each implant stimulator template 208 has an implant outline 210 that defines an area corresponding to an implanted stimulator of the bilateral hearing implant system.

    [0020] Each adjustable connection 209 is configured to allow adjustment of the position of the implant stimulator template 208 with respect to the corresponding BTE processor template 206 so as to define stimulator implantation sites at symmetric locations on each side of the patient's head 201. For example, in the embodiment shown in Figs. 2A and 2B, each adjustable connection 209 configured to enable the corresponding implant stimulator template 208 to adjustably pivot through an adjustment angle with respect to the corresponding BTE processor template 206.

    [0021] Although Figure 2 shows an embodiment with BTE processor templates 206, in some embodiments one or both of those may be omitted. For example, in some bilateral hearing systems, there may only be one BTE processor on one side, with no BTE processor on the other side. In that case, the BTE processor template 206 is only needed and used on that side. In other systems, the BTE processor templates 206 may be omitted for other reasons. When there is no BTE processor template 206, the implant stimulator template 208 may be directly connected to the adjustable headpiece 203 by an adjustable connector 209.

    [0022] Figure 3 shows another embodiment of another symmetric surgical template arrangement 300 without a headpiece. A behind the ear (BTE) processor template 301 is configured to fit behind the ear pinna of the recipient patient and to conform against an underlying side of the patient's head. The BTE processor template 301 also has a processor outline 310 that defines an area corresponding to an external BTE processor device of the bilateral hearing implant system in a post-surgical operational position. An implant stimulator template 302 is connected to the BTE processor template 301 by an adjustable connection 303 and also is configured to conform against an underlying side of the head. The implant stimulator template 302 has an implant outline 309 defining an area corresponding to an implanted stimulator of the bilateral hearing implant system. The adjustable connection 303 is configured to allow adjustment of the position of the implant stimulator template 302 with respect to the BTE processor template 301 so as to define stimulator implantation sites at symmetric locations on each side of the patient's head.

    [0023] In the embodiment shown in Fig. 3, the adjustable connection 303 is configured to enable the implant stimulator template 302 to slide within an adjustment slot 308 about an adjustable pivot 307 to set an adjustment angle with respect to the BTE processor template 301. Here the adjustable connection 303 allows adjustable pivoting of the implant stimulator template 302 through a limited range of recommended adjustment angles as shown by an angle indicator scale 304 that provides a visual indication of the adjustment angle. In addition, the adjustable connection 303 also allows adjustment of the distance between the implant stimulator template 302 and the BTE processor template 301 as shown on an indexed scale along the length of the adjustable connection 303.

    [0024] The implant stimulator template 302 also has a holding magnet 306 located within the outer outline 309 that is configured to hold the implant stimulator template 302 securely on the skin over an implanted magnet of a previously implanted stimulator to allow determination of the adjustment angle. The implant stimulator template 302 also includes marking openings 305 that are configured for location marking on the underlying tissue during implantation surgery. For example, the surgeon may use a needle and/or a syringe through the marking openings 305 to apply bone markers through the skin directly on the skull of the patient or a marker pen directly on the skin to show the desired location of the implant stimulator. Any or all of the templates may specifically be made of malleable plate metal and/or resilient polymer material.

    [0025] As with the previous Figure 2 embodiment, in some embodiments of a surgical template arrangement 300, one or both of BTE processor templates 301 may be omitted. For example, in some bilateral hearing systems, there may only be one BTE processor on one side, with no BTE processor on the other side. In that case, the BTE processor template 301 is only needed and used on that side. In other systems, the BTE processor templates 301 may be omitted for other reasons. When there is no BTE processor template 301, the implant stimulator template 302 may be configured to fit behind the ear pinna of directly by an adjustable connection 303.

    [0026] Figure 4 shows another embodiment of a symmetric surgical template arrangement 400 with BTE processor template 401 that is connected to an implant stimulator template 405 by an adjustable malleable plate 402. An adjustable angle setting slot 403 allows setting an adjustment angle 404 within a pre-defined recommended range by an adjustment slot 403; for example as shown in Fig. 4, from a first position 406 at a first adjustment angle 404 to a second position 407 at a second adjustment angle.

    [0027] Any or all of the templates and/or the adjustable connection in the above embodiments may specifically be made of malleable plate metal and/or resilient polymer material and they may be reusable or single use. For example, they may be made of thin bendable surgical grade stainless steel to be adaptable to individual head shape. And the templates and their labelling are configured for use on both sides of the head, left and right. This may include having labels and markings on both sides of the template arrangements.

    [0028] Template arrangements such as those described above can be used as a planning tool on the skin of the patient before and during implantation surgery for a bilateral hearing implant system. For example, after implantation of a first implant on one side, the implant magnet of the first implant that is located under the skin can be located and used as a reference point for planning the second implant. When the implant magnet position is defined the adjustment angle between the two template parts can be measured. The same adjustment angle is then used for the opposite side of the patient's head where the second system will be implanted. The marking hole in the implant stimulator template can be used to mark the implant target location directly on the skull or on the skin of the patient.

    [0029] Such template arrangements can ensure symmetrical fixation of the implant. It also reduces the surgical time in marking the implant stimulator position. Symmetrical positioning of the two implants also has a better cosmetic effect for bilateral implanted patients because of the symmetric appearance of the external parts.

    [0030] Although various exemplary embodiments of the invention have been disclosed, it should be apparent to those skilled in the art that various changes and modifications can be made which will achieve at least some of the advantages of the invention without departing from the true scope of the invention. For example, the approaches described herein could be applied for hearing prostheses other than cochlear implants such as an auditory brainstem implant with the electrical stimuli presented by electrodes within or adjacent to the cochlear nucleus, or an auditory midbrain implant with the electrical stimuli presented by electrodes on or within the inferior colliculus. In addition, corresponding systems, and methods of use thereof, may also be used for deep brain stimulation.


    Claims

    1. A surgical template arrangement for a bilateral hearing implant system, the arrangement comprising:

    an implant stimulator template (208, 302, 405) comprising an implant outline (210, 309) defining an area corresponding to an implanted stimulator of the bilateral hearing implant system; and

    an adjustable connection (209, 303, 402, 403) connecting the implant stimulator template (208) to a behind the ear (BTE) processor template (205, 301, 401) configured to fit behind the ear pinna (202) of the recipient patient (201) and configured to conform against an underlying side of the head (201), the adjustable connection (209) being configured to allow angular and linear adjustment of the position of the implant stimulator template (208) with respect to the outer ear pinna (202) so as to define stimulator implantation sites at symmetric locations on each side of the patient's head (201).


     
    2. The template arrangement according to claim 1, wherein the adjustable connection is configured to enable the implant stimulator template to adjustably pivot through a a limited range of recommended adjustment angles with respect to the outer ear pinna.
     
    3. The template arrangement according to claim 2, further comprising:
    an angle indicator scale (304) configured to provide a visual indication of the adjustment angle.
     
    4. The template arrangement according to claim 2, further comprising:
    a holding magnet (306) located within the outer outline of the implant stimulator template (302) configured to hold the implant stimulator template (302) securely on the skin over an implanted magnet of a previously implanted stimulator to allow determination of the adjustment angle.
     
    5. The template arrangement according to claim 1, wherein the implant stimulator template includes a plurality of marking openings configured for location marking on the underlying tissue during implantation surgery.
     
    6. The template arrangement according to claim 1, wherein
    the behind the ear (BTE) processor template comprises a processor outline defining an area corresponding to an external BTE processor device of the bilateral hearing implant system.
     
    7. A surgical template arrangement for a bilateral hearing implant system, the arrangement comprising:

    an adjustable headpiece (203) with left and right sides is configured to fit over the head of a surgical patient;

    left and right implant stimulator templates (208), each connected to a corresponding left and right side of the adjustable headpiece (203) by an adjustable connection (209) and configured to conform against an underlying side of the patient's head, wherein each implant stimulator template (208) has an implant outline (210) defining an area corresponding to an implanted stimulator of the bilateral hearing implant system, and wherein each adjustable connection is configured to allow adjustment of the position of the implant stimulator template (208) with respect to the adjustable headpiece (203) so as to define stimulator implantation sites at symmetric locations on each side of the patient's head.


     
    8. The template arrangement according to claim 8, wherein each adjustable connection (209) is configured to enable the corresponding implant stimulator template (208) to adjustably pivot through an adjustment angle with respect to the adjustable headpiece (203).
     
    9. The template arrangement according to claim 9, wherein each adjustable connection (209) is configured to allow adjustable pivoting through a limited range of recommended adjustment angles.
     
    10. The template arrangement according to claim 9, further comprising:
    an angle indicator scale configured to provide a visual indication of the adjustment angle.
     
    11. The template arrangement according to claim 9, further comprising:
    a holding magnet located within the outer outline of one of the implant stimulator templates configured to hold that implant stimulator template securely on the skin over an implanted magnet of a previously implanted stimulator to allow determination of the adjustment angle.
     
    12. The template arrangement according to claim 8, wherein each implant stimulator template includes a plurality of marking openings configured for location marking on the underlying tissue during implantation surgery.
     
    13. The template arrangement according to claim 8, further comprising:
    at least one (BTE) processor template (205) located on the adjustable headpiece (203) at one of the adjustable connections to the corresponding left and right side implant stimulator templates (208), wherein the at least one BTE processor template (205) has a processor outline defining an area corresponding to an external BTE processor device of the bilateral hearing implant system, and wherein the at least one BTE processor template (205) is configured to fit behind the ear pinna (202) of the recipient patient in a post-surgical operational position and conform against an underlying side of the patient's head.
     
    14. The template arrangement according to claim 14, wherein the at least one BTE processor template (205) comprises a pair of left and right side BTE processor templates, each BTE processor template being located on the adjustable headpiece (203) at the adjustable connection (209) for the corresponding left and right side implant stimulator templates.
     


    Ansprüche

    1. Chirurgische Schablonenbaugruppe für ein beidseitiges Hörimplantatsystem, wobei die Baugruppe umfasst:

    eine Stimulatorimplantatschablone (208, 302, 405), umfassend einen Implantatumriss (210, 309), der einen Bereich definiert, der einem implantierten Stimulator des beidseitigen Hörimplantatsystems entspricht; und

    ein einstellbares Verbindungselement (209, 303, 402, 403), das die Stimulatorimplantatschablone (208) mit einer Hinterohr(BTE)-Prozessorschablone (205, 301, 401) verbindet, die dafür gestaltet ist, hinter die Ohrmuschel (202) des Empfängerpatienten (201) zu passen, und dafür gestaltet ist, an eine darunterliegender Seite des Kopfs (201) angepasst zu sein, wobei das einstellbare Verbindungselement (209) dafür gestaltet ist, Winkel- und lineare Einstellung der Position der Stimulatorimplantatschablone (208) relativ zu der Ohrmuschel (202) zu erlauben, um Stimulatorimplantationsorte an symmetrischen Orten an jeder Seite des Kopfs des Patienten (201) zu definieren.


     
    2. Schablonenbaugruppe gemäß Anspruch 1, wobei das einstellbare Verbindungselement dafür gestaltet ist, der Stimulatorimplantatschablone zu ermöglichen, einstellbar durch einen beschränkten Bereich von empfohlenen Einstellwinkeln relativ zu der Ohrmuschel zu schwenken.
     
    3. Schablonenbaugruppe gemäß Anspruch 2, ferner umfassend:

    eine Winkelanzeigeskala (304), dafür gestaltet,

    eine visuelle Anzeige des Einstellwinkels bereitzustellen.


     
    4. Schablonenbaugruppe gemäß Anspruch 2, ferner umfassend:
    einen Haltemagneten (306), der innerhalb des Außenumrisses der Stimulatorimplantatschablone (302) angeordnet ist, dafür gestaltet, die Stimulatorimplantatschablone (302) sicher an der Haut über einem implantierten Magneten eines zuvor implantierten Stimulators zu halten, um die Bestimmung des Einstellwinkels zu ermöglichen.
     
    5. Schablonenbaugruppe gemäß Anspruch 1, wobei die Stimulatorimplantatschablone eine Vielzahl von Markierungsöffnungen aufweist, die zur Ortsmarkierung an dem darunterliegenden Gewebe während Implantationschirurgie gestaltet sind.
     
    6. Schablonenbaugruppe gemäß Anspruch 1, wobei
    die Hinterohr(BTE)-Prozessorschablone einen Prozessorumriss umfasst, der einen Bereich definiert, der einer externen BTE-Prozessorvorrichtung des beidseitigen Hörimplantatsystems entspricht.
     
    7. Chirurgische Schablonenbaugruppe für ein beidseitiges Hörimplantatsystem, wobei die Baugruppe umfasst:

    ein einstellbares Kopfstück (203) mit linken und rechten Seiten, dafür gestaltet, über den Kopf eines Chirurgiepatienten zu passen;

    linke und rechte Stimulatorimplantatschablonen (208), die jeweils durch ein einstellbares Verbindungselement (209) mit einer entsprechenden linken bzw. rechten Seite des einstellbaren Kopfstücks (203) verbunden sind und dafür gestaltet sind, an eine darunterliegende Seite des Kopfs des Patienten angepasst zu sein,

    wobei jede Stimulatorimplantatschablone (208) einen Implantatumriss (210) aufweist, der einen Bereich definiert, der einem implantierten Stimulator des beidseitigen Hörimplantatsystems entspricht, und

    wobei jedes einstellbare Verbindungselement dafür gestaltet ist, Einstellung der Position der Stimulatorimplantatschablone (208) relativ zu dem einstellbaren Kopfstück (203) zu erlauben, um Stimulatorimplantationsorte an symmetrischen Orten an jeder Seite des Kopfs des Patienten zu definieren.


     
    8. Schablonenbaugruppe gemäß Anspruch 8, wobei jedes einstellbare Verbindungselement (209) dafür gestaltet ist, der entsprechenden Stimulatorimplantatschablone (208) zu ermöglichen, einstellbar durch einen Einstellwinkel relativ zu dem einstellbaren Kopfstück (203) zu schwenken.
     
    9. Schablonenbaugruppe gemäß Anspruch 9, wobei jedes einstellbare Verbindungselement (209) dafür gestaltet ist, einstellbares Schwenken durch einen beschränkten Bereich von empfohlenen Einstellwinkel zu ermöglichen.
     
    10. Schablonenbaugruppe gemäß Anspruch 9, ferner umfassend:
    eine Winkelanzeigeskala, dafür gestaltet, eine visuelle Anzeige des Einstellwinkels bereitzustellen.
     
    11. Schablonenbaugruppe gemäß Anspruch 9, ferner umfassend:
    einen Haltemagneten, der innerhalb des Außenumrisses der Stimulatorimplantatschablone angeordnet ist, dafür gestaltet, die Stimulatorimplantatschablone sicher an der Haut über einem implantierten Magneten eines zuvor implantierten Stimulators zu halten, um die Bestimmung des Einstellwinkels zu ermöglichen.
     
    12. Schablonenbaugruppe gemäß Anspruch 8, wobei jede Stimulatorimplantatschablone eine Vielzahl von Markierungsöffnungen aufweist, die zur Ortsmarkierung an dem darunterliegenden Gewebe während Implantationschirurgie gestaltet sind.
     
    13. Schablonenbaugruppe gemäß Anspruch 8, ferner umfassend:

    wenigstens eine (BTE)-Prozessorschablone (205), die an dem einstellbaren Kopfstück (203) an einem der einstellbaren Verbindungselemente mit der entsprechenden linken bzw. rechten Stimulatorimplantatschablone (208) angeordnet ist,

    wobei die wenigstens eine BTE-Prozessorschablone (205) einen Prozessorumriss aufweist, der einen Bereich definiert, der einer externen BTE-Prozessorvorrichtung des beidseitigen Hörimplantatsystems entspricht, und wobei die wenigstens eine BTE-Prozessorschablone (205) dafür gestaltet ist, hinter die Ohrmuschel (202) des Empfängerpatienten in einer postchirurgischen Arbeitsposition zu passen und an eine darunterliegende Seite des Kopfs des Patienten angepasst zu sein.


     
    14. Schablonenbaugruppe gemäß Anspruch 14, wobei die wenigstens eine BTE-Prozessorschablone (205) ein Paar von links- und rechtsseitigen BTE-Prozessorschablonen umfasst, wobei jede BTE-Prozessorschablone an dem einstellbaren Kopfstück (203) an dem einstellbaren Verbindungselement (209) für die entsprechenden links- und rechtsseitigen Stimulatorimplantatschablonen angeordnet ist.
     


    Revendications

    1. Agencement de gabarit chirurgical pour un système d'implant auditif bilatéral, l'agencement comprenant :

    un gabarit de stimulateur d'implant (208, 302, 405) comprenant un contour d'implant (210, 309) définissant une zone correspondant à un stimulateur implanté du système d'implant auditif bilatéral ; et

    une connexion réglable (209, 303, 402, 403) connectant le gabarit de stimulateur d'implant (208) à un gabarit de processeur (205, 301, 401) de contour d'oreille (BTE) configuré pour s'adapter derrière le pavillon de l'oreille (202) du patient receveur (201) et configuré pour se conformer à un côté sous-jacent de la tête (201), la connexion réglable (209) étant configurée pour permettre un ajustement angulaire et linéaire de la position du gabarit de stimulateur d'implant (208) par rapport au pavillon externe de l'oreille (202) afin de définir des sites d'implantation de stimulateur à des endroits symétriques de chaque côté de la tête du patient (201).


     
    2. Agencement de gabarit selon la revendication 1, la connexion réglable étant configurée pour permettre au gabarit de stimulateur d'implant de pivoter de manière réglable sur une plage limitée d'angles de réglage recommandés par rapport au pavillon externe de l'oreille.
     
    3. Agencement de gabarit selon la revendication 2, comprenant en outre :
    une échelle indicatrice d'angle (304) configurée pour fournir une indication visuelle de l'angle de réglage.
     
    4. Agencement de gabarit selon la revendication 2, comprenant en outre :
    un aimant de maintien (306) situé dans le contour extérieur du gabarit de stimulateur d'implant (302) configuré pour maintenir le gabarit de stimulateur d'implant (302) fermement sur la peau au-dessus d'un aimant implanté d'un stimulateur précédemment implanté pour permettre la détermination de l'angle de réglage.
     
    5. Agencement de gabarit selon la revendication 1, le gabarit de stimulateur d'implant comprenant une pluralité d'ouvertures de marquage configurées pour le marquage de l'emplacement sur le tissu sous-jacent pendant la chirurgie d'implantation.
     
    6. Agencement de gabarit selon la revendication 1, le gabarit de processeur de contour d'oreille (BTE) comprenant un contour de processeur définissant une zone correspondant à un dispositif de processeur BTE externe du système d'implant auditif bilatéral.
     
    7. Agencement de gabarit chirurgical pour un système d'implant auditif bilatéral, l'agencement comprenant :

    un élément crânien réglable (203) avec des côtés gauche et droit, configuré pour s'adapter sur la tête d'un patient en chirurgie ;

    des gabarits de stimulateur d'implant gauche et droit (208), chacun étant connecté à un côté gauche et droit correspondant de l'élément crânien réglable (203) par une connexion réglable (209) et configuré pour se conformer à un côté sous-jacent de la tête du patient, chaque gabarit de stimulateur d'implant (208) ayant un contour d'implant (210) définissant une zone correspondant à un stimulateur implanté du système d'implant auditif bilatéral, et chaque connexion réglable étant configurée pour permettre le réglage de la position du gabarit de stimulateur d'implant (208) par rapport à l'élément crânien réglable (203) de manière à définir des sites d'implantation de stimulateur à des endroits symétriques de chaque côté de la tête du patient.


     
    8. Agencement de gabarit selon la revendication 8, chaque connexion réglable (209) étant configurée pour permettre au gabarit de stimulateur d'implant correspondant (208) de pivoter de manière réglable selon un angle de réglage par rapport à l'élément crânien réglable (203).
     
    9. Agencement de gabarit selon la revendication 9, chaque connexion réglable (209) étant configurée pour permettre un pivotement réglable sur une plage limitée d'angles de réglage recommandés.
     
    10. Agencement de gabarit selon la revendication 9, comprenant en outre :
    une échelle indicatrice d'angle configurée pour fournir une indication visuelle de l'angle de réglage.
     
    11. Agencement de gabarit selon la revendication 9, comprenant en outre :
    un aimant de maintien situé dans le contour extérieur de l'un des gabarits de stimulateur d'implant configuré pour maintenir ce gabarit de stimulateur d'implant fermement sur la peau au-dessus d'un aimant implanté d'un stimulateur précédemment implanté pour permettre la détermination de l'angle de réglage.
     
    12. Agencement de gabarit selon la revendication 8, chaque gabarit de stimulateur d'implant comprenant une pluralité d'ouvertures de marquage configurées pour le marquage de l'emplacement sur le tissu sous-jacent pendant la chirurgie d'implantation.
     
    13. Agencement de gabarit selon la revendication 8, comprenant en outre :
    au moins un gabarit de processeur (BTE) (205) situé sur l'élément crânien réglable (203) au niveau de l'une des connexions réglables aux gabarits de stimulateur d'implant gauche et droit correspondants (208), l'au moins un gabarit de processeur BTE (205) ayant un contour de processeur définissant une zone correspondant à un dispositif de processeur BTE externe du système d'implant auditif bilatéral, et l'au moins un gabarit de processeur BTE (205) étant configuré pour s'adapter derrière le pavillon de l'oreille (202) du patient receveur dans une position opérationnelle post-chirurgicale et se conformer à un côté sous-jacent de la tête du patient.
     
    14. Agencement de gabarit selon la revendication 14, l'au moins un gabarit de processeur BTE (205) comprenant une paire de gabarits de processeur BTE gauche et droit, chaque gabarit de processeur BTE étant situé sur l'élément crânien réglable (203) au niveau de la connexion réglable (209) pour les gabarits de stimulateur d'implant gauche et droit correspondants.
     




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    Cited references

    REFERENCES CITED IN THE DESCRIPTION



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    Patent documents cited in the description