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US20160015401A1 - Customized drilling jig for implantation of a hearing aid - Google Patents

Customized drilling jig for implantation of a hearing aid Download PDF

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Publication number
US20160015401A1
US20160015401A1 US14/803,311 US201514803311A US2016015401A1 US 20160015401 A1 US20160015401 A1 US 20160015401A1 US 201514803311 A US201514803311 A US 201514803311A US 2016015401 A1 US2016015401 A1 US 2016015401A1
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United States
Prior art keywords
jig
drilling
patient
hearing aid
implantation
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.)
Abandoned
Application number
US14/803,311
Inventor
Pierre-Yves Clair
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Advanced Bionics AG
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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 US14/803,311 priority Critical patent/US20160015401A1/en
Publication of US20160015401A1 publication Critical patent/US20160015401A1/en
Assigned to ADVANCED BIONICS AG reassignment ADVANCED BIONICS AG ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CLAIR, PIERRE-YVES
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/171—Guides or aligning means for drills, mills, pins or wires for external fixation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3983—Reference marker arrangements for use with image guided surgery

Definitions

  • the present invention relates to a drilling jig for implantation of a hearing aid and to a method of producing such hearing aid.
  • the invention also relates to a method of implanting a hearing aid by using such jig.
  • hearing aids are implanted without using automated drilling tools.
  • German Patent Application DE 100 49 938 A1 relates to a surgery method wherein, during surgery, a helmet-like instrument holder comprising a shell is fixed on the patient's head, with the shell of the instrument holder in addition being fixed at the teeth of the patient.
  • the instrument holder is used for positioning a drilling jig in a defined manner. Prior to surgery, images of the respective part of the patient's body are taken.
  • German Patent DE 197 28 864 C2 relates to a method for dental surgery which uses a jig comprising openings for receiving titanium sleeves for guiding the drilling instrument for dental implantation.
  • the jig is fixed at some of the teeth.
  • An image of the patient's mouth is taken with the jig in place, wherein the sleeves act as markers.
  • the position of the sleeves in the jig is modified according to the image prior to using the jig for surgery.
  • these objects are achieved by a method of producing a drilling jig, a customized drilling jig and a method of implanting a hearing aid using such customized jig as described herein.
  • the invention is beneficial in that, by providing for a customized drilling jig comprising a print of the patient's upper teeth and a lateral beam with a drilling guide opening designed to guide the drilling tool along a minimally invasive drilling axis for drilling a cavity into the patient's head for implantation of the hearing aid, with the drilling axis having been previously determined based on a three-dimensional image of the patient's head produced prior to surgery with a standard jig positioned at the patient's head by using the teeth print, the drilling tool can be guided during surgery in a reliable manner along the previously determined minimally invasive drilling axis, whereby precision of the surgery can be improved and duration of the surgery can be reduced.
  • the customized jig can be produced prior to surgery outside the operation room.
  • FIG. 1 is a view of a patient's skull without mandible seen from below;
  • FIG. 2 is a view like FIG. 1 , but with a customized drilling jig according to the invention having been put into place;
  • FIG. 3 is a side view of the patient's skull with the jig in place
  • FIG. 4 is a front view of the patient's skull with the jig in place
  • FIG. 5 is a perspective view of the patient's skull with a minimally invasive drilling axis, wherein the jig is shown prior to being provided with a drilling guide opening;
  • FIG. 6 is a perspective view of the patient's skull with the customized jig in place when used in surgery with a drilling tool.
  • a print (molded imprint) 14 of the patient's upper teeth 12 is captured by solidifying an appropriate elastic material, in a manner as it is done by a dentist. Then, the molded imprint of the teeth 14 is connected to a jig 16 comprising a U-shaped portion 18 for connecting to the molded imprint 14 and a lateral beam 20 that is connected to the portion 18 is positioned extending up to the region behind patient's ear.
  • the jig 16 is radiolucent and comprises at least three navigation benchmarks 22 which are radioopaque (see, FIG. 2 ).
  • a three-dimensional image of the patient's skull 10 with the jig 16 having been positioned at the patient's head 10 by using the molded imprint 14 is taken, for example, by using a computer tomography (CT) device.
  • CT computer tomography
  • a navigation simulation procedure is carried-out on the base of the three-dimensional image of the patient's skull 10 and the position of the navigation benchmarks 22 on the image are used in order to determine a minimal-invasive drilling axis 28 for hearing aid implantation (see, FIG. 5 ).
  • Such a simulation is performed out of the operation room.
  • the position and orientation of a customized drilling guide opening 24 which is to be provided at the lateral beam 20 of the jig 16 for guiding a drilling tool 26 , is determined from the determined minimal invasive drilling axis and the position of the jig 16 relative to the patient's head 10 (this relative position is determined by the molded imprint 14 ).
  • the thus obtained data and the jig 16 are sent to an external manufacturer (i.e., one outside of the operating room) who manufactures a customized jig 16 , based on this data, with the customized drilling guide opening 24 in the lateral beam 20 of the jig 16 using an appropriate tool (the opening 24 is shown in FIGS. 3 , 4 and 6 ).
  • the jig 16 is positioned on the patient's head 10 using the mold imprint 14 as a positioning element, the mandible acting as a type of natural clamp. Then, a cavity for implantation of the hearing aid is drilled into the patient's head using a drilling tool 26 which is guided by the drilling guide opening 24 of the jig 16 .
  • a navigation system or a CT device can be used to check the drilling progress. Prior to the operation, the position of the drilling tool 26 relative to the patient's head 10 may be checked using X-rays.
  • the drilling depth and the creation of simply-shaped cavities can be controlled by the navigation system or by using mechanical blocking means provided at the drilling guide opening 24 of the jig 16 .
  • such control is used to block the drilling tool 26 when a predetermined depth is reached.
  • the jig 16 can be removed from the teeth 12 in a very short time (a few seconds).
  • the jig 16 can be discarded.
  • the actually obtained cavity may be compared with the determined minimal invasive drilling axis in order to statistically refine the procedure of determining the minimal invasive drilling axis.
  • the present invention allows for minimal-invasive implantation of hearing aids with a short surgical duration, whereby exposure and risk for the patient is minimized. No invasive navigation marks are necessary, and no special equipment, technical adjustment and engineers are needed in the operating room, so that the proposed procedure is suitable for any clinic doing auditory implants.
  • the invention also allows for simpler and more robust hearing aid designs. Finally, the costs of the jig will be low.
  • the present invention can be used, for example, for implanting electro-mechanical hearing aid actuators, such as actuators for direct acoustic cochlear stimulation, and for implantation of cochlear electrodes.
  • the hearing aid comprises a cylindrical housing to be inserted into the cavity.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Dentistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pathology (AREA)
  • Dental Prosthetics (AREA)

Abstract

A customized drilling jig for implantation of a hearing aid involves a molded imprint (14) of a patient's upper teeth (12) made of a solidified elastic material connected to a jig (16) having a lateral beam (20) and navigation benchmarks (22) and with which a three-dimensional image of the patient's head can be captured for determining a minimal invasive drilling axis (28) for hearing aid implantation based on the three-dimensional image. The customized jig has a drilling guide opening in a lateral beam of the jig for guiding a drilling tool (26). The position and orientation of the drilling guide opening are selected to guide the drilling tool along the determined minimal invasive drilling axis when the jig is positioned on the patient's head by using the imprint (14).

Description

    CROSS REFERENCE TO RELATED APPLICATION
  • This application is a division of commonly owned, co-pending U.S. patent application Ser. No. 13/580,696, filed Oct. 25, 2012, which is a §371 of PCT/EP2010/052240 filed Feb. 23, 2010.
    • BACKGROUND OF THE INVENTION
  • 1. Field of the Invention
  • The present invention relates to a drilling jig for implantation of a hearing aid and to a method of producing such hearing aid. The invention also relates to a method of implanting a hearing aid by using such jig.
  • 2. Description of Related Art
  • Typically, hearing aids are implanted without using automated drilling tools.
  • German Patent Application DE 100 49 938 A1 relates to a surgery method wherein, during surgery, a helmet-like instrument holder comprising a shell is fixed on the patient's head, with the shell of the instrument holder in addition being fixed at the teeth of the patient. The instrument holder is used for positioning a drilling jig in a defined manner. Prior to surgery, images of the respective part of the patient's body are taken.
  • German Patent DE 197 28 864 C2 relates to a method for dental surgery which uses a jig comprising openings for receiving titanium sleeves for guiding the drilling instrument for dental implantation. The jig is fixed at some of the teeth. An image of the patient's mouth is taken with the jig in place, wherein the sleeves act as markers. The position of the sleeves in the jig is modified according to the image prior to using the jig for surgery.
    • SUMMARY OF THE INVENTION
  • It is an object of the invention to provide for a tool which enables fast, easy, safe and inexpensive implantation of a hearing aid. It is also an object to provide for a method of producing such tool. It is a further object to provide for a corresponding method of implanting a hearing aid by using such tool.
  • According to the invention, these objects are achieved by a method of producing a drilling jig, a customized drilling jig and a method of implanting a hearing aid using such customized jig as described herein.
  • The invention is beneficial in that, by providing for a customized drilling jig comprising a print of the patient's upper teeth and a lateral beam with a drilling guide opening designed to guide the drilling tool along a minimally invasive drilling axis for drilling a cavity into the patient's head for implantation of the hearing aid, with the drilling axis having been previously determined based on a three-dimensional image of the patient's head produced prior to surgery with a standard jig positioned at the patient's head by using the teeth print, the drilling tool can be guided during surgery in a reliable manner along the previously determined minimally invasive drilling axis, whereby precision of the surgery can be improved and duration of the surgery can be reduced. In particular, the customized jig can be produced prior to surgery outside the operation room.
  • These and further objects, features and advantages of the present invention will become apparent from the following description when taken in connection with the accompanying drawings which, for purposes of illustration only, show several embodiments in accordance with the present invention.
    • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is a view of a patient's skull without mandible seen from below;
  • FIG. 2 is a view like FIG. 1, but with a customized drilling jig according to the invention having been put into place;
  • FIG. 3 is a side view of the patient's skull with the jig in place;
  • FIG. 4 is a front view of the patient's skull with the jig in place;
  • FIG. 5 is a perspective view of the patient's skull with a minimally invasive drilling axis, wherein the jig is shown prior to being provided with a drilling guide opening; and
  • FIG. 6 is a perspective view of the patient's skull with the customized jig in place when used in surgery with a drilling tool.
    •  DETAILED DESCRIPTION OF THE INVENTION
  • In order to produce a customized drilling jig for implantation of a hearing aid, first a print (molded imprint) 14 of the patient's upper teeth 12 is captured by solidifying an appropriate elastic material, in a manner as it is done by a dentist. Then, the molded imprint of the teeth 14 is connected to a jig 16 comprising a U-shaped portion 18 for connecting to the molded imprint 14 and a lateral beam 20 that is connected to the portion 18 is positioned extending up to the region behind patient's ear. The jig 16 is radiolucent and comprises at least three navigation benchmarks 22 which are radioopaque (see, FIG. 2).
  • A three-dimensional image of the patient's skull 10 with the jig 16 having been positioned at the patient's head 10 by using the molded imprint 14 is taken, for example, by using a computer tomography (CT) device.
  • Then, a navigation simulation procedure is carried-out on the base of the three-dimensional image of the patient's skull 10 and the position of the navigation benchmarks 22 on the image are used in order to determine a minimal-invasive drilling axis 28 for hearing aid implantation (see, FIG. 5). Such a simulation is performed out of the operation room. The position and orientation of a customized drilling guide opening 24, which is to be provided at the lateral beam 20 of the jig 16 for guiding a drilling tool 26, is determined from the determined minimal invasive drilling axis and the position of the jig 16 relative to the patient's head 10 (this relative position is determined by the molded imprint 14).
  • The thus obtained data and the jig 16 are sent to an external manufacturer (i.e., one outside of the operating room) who manufactures a customized jig 16, based on this data, with the customized drilling guide opening 24 in the lateral beam 20 of the jig 16 using an appropriate tool (the opening 24 is shown in FIGS. 3, 4 and 6).
  • Surgery then is performed by using the customized jig 16 (see, FIG. 6). To this end, first, the jig 16 is positioned on the patient's head 10 using the mold imprint 14 as a positioning element, the mandible acting as a type of natural clamp. Then, a cavity for implantation of the hearing aid is drilled into the patient's head using a drilling tool 26 which is guided by the drilling guide opening 24 of the jig 16. A navigation system or a CT device can be used to check the drilling progress. Prior to the operation, the position of the drilling tool 26 relative to the patient's head 10 may be checked using X-rays. The drilling depth and the creation of simply-shaped cavities (for example, step-shaped cavities) can be controlled by the navigation system or by using mechanical blocking means provided at the drilling guide opening 24 of the jig 16. In particular, such control is used to block the drilling tool 26 when a predetermined depth is reached.
  • In case of an emergency, the jig 16 can be removed from the teeth 12 in a very short time (a few seconds).
  • At the end of the procedure, the jig 16 can be discarded.
  • The actually obtained cavity may be compared with the determined minimal invasive drilling axis in order to statistically refine the procedure of determining the minimal invasive drilling axis.
  • The present invention allows for minimal-invasive implantation of hearing aids with a short surgical duration, whereby exposure and risk for the patient is minimized. No invasive navigation marks are necessary, and no special equipment, technical adjustment and engineers are needed in the operating room, so that the proposed procedure is suitable for any clinic doing auditory implants. The invention also allows for simpler and more robust hearing aid designs. Finally, the costs of the jig will be low.
  • The present invention can be used, for example, for implanting electro-mechanical hearing aid actuators, such as actuators for direct acoustic cochlear stimulation, and for implantation of cochlear electrodes. Typically, the hearing aid comprises a cylindrical housing to be inserted into the cavity.
  • While various embodiments in accordance with the present invention have been shown and described, it is understood that the invention is not limited thereto, and is susceptible to numerous changes and modifications as known to those skilled in the art. Therefore, this invention is not limited to the details shown and described herein, and includes all such changes and modifications as encompassed by the scope of the appended claims.

Claims (1)

What is claimed is:
1. A customized drilling jig for implantation of a hearing aid into a patient's head, comprising a dental imprint of the patient's upper teeth and a lateral beam which is fixedly connected to the dental imprint and which comprises a drilling guide opening positioned to guide a drilling tool along a minimally invasive drilling axis for drilling a cavity into the patient's head for implantation of the hearing aid when the jig is positioned on the patient's head held by the dental imprint against the patient's teeth, with the drilling axis having been determined based on a three-dimensional image of the patient's head.
US14/803,311 2010-02-23 2015-07-20 Customized drilling jig for implantation of a hearing aid Abandoned US20160015401A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US14/803,311 US20160015401A1 (en) 2010-02-23 2015-07-20 Customized drilling jig for implantation of a hearing aid

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
PCT/EP2010/052240 WO2010061006A2 (en) 2010-02-23 2010-02-23 Customized drilling jig for implantation of a hearing aid
US201213580696A 2012-10-25 2012-10-25
US14/803,311 US20160015401A1 (en) 2010-02-23 2015-07-20 Customized drilling jig for implantation of a hearing aid

Related Parent Applications (2)

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US13/580,696 Division US9113922B2 (en) 2010-02-23 2010-02-23 Customized drilling jig for implantation of a hearing aid
PCT/EP2010/052240 Division WO2010061006A2 (en) 2010-02-23 2010-02-23 Customized drilling jig for implantation of a hearing aid

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US20160015401A1 true US20160015401A1 (en) 2016-01-21

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US14/803,311 Abandoned US20160015401A1 (en) 2010-02-23 2015-07-20 Customized drilling jig for implantation of a hearing aid

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WO2010133704A2 (en) 2010-09-27 2010-11-25 Advanced Bionics Ag Implantable hearing instrument
WO2010133706A2 (en) 2010-09-27 2010-11-25 Advanced Bionics Ag Hearing instrument for round or oval window stimulation
WO2010133705A2 (en) 2010-09-27 2010-11-25 Advanced Bionics Ag Hearing instrument for round window stimulation
JP6151570B2 (en) * 2013-05-29 2017-06-21 株式会社大野興業 Surgical jig, confirmation jig, and method of manufacturing these jigs
US20150216541A1 (en) * 2014-02-03 2015-08-06 Arthrex, Inc. Pointing device and drilling tool
EP3203951B1 (en) 2014-10-06 2020-04-29 Med-El Elektromedizinische Geraete GmbH Template for bilateral symmetric stimulator fixation/implantation
CN106821497B (en) * 2017-03-16 2023-10-31 上海市肺科医院 Precise positioning and disposal method of target site and auxiliary device
CN109758208B (en) * 2019-03-04 2020-12-08 美创医核公司 Osteotomy guide plate and preparation method thereof
US11751887B2 (en) 2019-12-18 2023-09-12 DePuy Synthes Products, Inc. Interoperative aiming arm
FR3124939A1 (en) 2021-07-10 2023-01-13 Steeve CHANTREL STEREOTAXIC DEVICE AND METHOD FOR MAKING A STEREOTAXIC DEVICE

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Publication number Publication date
EP2538856B1 (en) 2014-06-25
EP2538856A2 (en) 2013-01-02
US20130041381A1 (en) 2013-02-14
WO2010061006A3 (en) 2010-07-29
WO2010061006A2 (en) 2010-06-03
US9113922B2 (en) 2015-08-25

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Effective date: 20150809

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