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WO2025008686A1 - Système et procédé de mesure directe de force de rétention - Google Patents

Système et procédé de mesure directe de force de rétention Download PDF

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Publication number
WO2025008686A1
WO2025008686A1 PCT/IB2024/055300 IB2024055300W WO2025008686A1 WO 2025008686 A1 WO2025008686 A1 WO 2025008686A1 IB 2024055300 W IB2024055300 W IB 2024055300W WO 2025008686 A1 WO2025008686 A1 WO 2025008686A1
Authority
WO
WIPO (PCT)
Prior art keywords
magnet
magnetic force
implanted device
recipient
external
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.)
Pending
Application number
PCT/IB2024/055300
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English (en)
Inventor
Charles Roger Aaron Leigh
Oliver John RIDLER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cochlear Ltd
Original Assignee
Cochlear Ltd
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 Cochlear Ltd filed Critical Cochlear Ltd
Publication of WO2025008686A1 publication Critical patent/WO2025008686A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36036—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the outer, middle or inner ear
    • A61N1/36038—Cochlear stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/37518—Anchoring of the implants, e.g. fixation
    • 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 application relates generally to systems and methods for determining characteristics of a retention force between an external component and a device implanted on or within a recipient’s body, the retention force holding the external component on the recipient’s body.
  • Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices can include internal or implantable components/de vices, external or wearable components/devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). Medical devices, such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and/or lifestyle enhancement functions and/or recipient monitoring for a number of years.
  • medical devices such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and/or lifestyle enhancement functions and/or recipient monitoring for a number of years.
  • implantable medical devices now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease/injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and/or data received from external devices that are part of, or operate in conjunction with, implantable components.
  • an apparatus comprises a housing having an external surface configured to be placed on a skin surface of a recipient.
  • the apparatus further comprises a ferromagnetic or ferrimagnetic first element configured to, upon the housing being placed on the skin surface, generate an attractive magnetic force with a ferromagnetic or ferrimagnetic second element within an implanted device beneath the skin surface.
  • the apparatus further comprises a sensor within the housing and in communication with the first element. The sensor is configured to receive information regarding the second element and to generate an indication of at least one characteristic of an interaction between the first element and the second element.
  • a method comprises placing an apparatus on a recipient’s body over a portion of tissue overlying an implanted device.
  • the apparatus comprises a first magnet generating a first attractive magnetic force with the implanted device.
  • the method further comprises accessing first information indicative of a magnetic configuration of the implanted device.
  • the method further comprises using the apparatus to generate second information indicative of at least one characteristic of an interaction between the implanted device and the apparatus.
  • the method further comprises, in response to the first and second information, selecting a second magnet from a finite set of magnets compatible for insertion within an external device configured to interact with the implanted device.
  • an apparatus comprises at least two portions configured to be placed on a tissue surface of a recipient.
  • the apparatus further comprises at least one first magnet configured to, upon a first portion of the at least two portions being placed on the tissue surface, generate a first attractive magnetic force with an implanted device beneath the tissue surface.
  • the apparatus further comprises a transducer configured to generate a measurement signal indicative of the first attractive magnetic force.
  • the apparatus further comprises circuitry configured to receive the measurement signal and first information indicative of the first portion and to generate second information indicative of at least one of: the first attractive magnetic force; a tissue thickness between the first portion and the implanted device; and an attribute of a second magnetic force between the implanted device and an external device on the tissue surface in place of the apparatus, the second magnetic force sufficient to hold the external device on the tissue surface.
  • FIG. 1A is a perspective view of an example cochlear implant auditory prosthesis implanted in a recipient in accordance with certain implementations described herein;
  • FIG. IB is a perspective view of an example fully implantable middle ear implant auditory prosthesis implanted in a recipient in accordance with certain implementations described herein;
  • FIG. 1C schematically illustrates a side cross-sectional view of an example transcutaneous system comprising an implantable component and an external component;
  • FIGs. 2A and 2B schematically illustrate cross-sectional views of two example apparatus in accordance with certain implementations described herein;
  • FIGs. 3A-3G schematically illustrate various example types and combinations of the first element and the second element in accordance with certain implementations described herein;
  • FIG. 4 schematically illustrates another example apparatus in accordance with certain implementations described herein;
  • FIGs. 5A and 5B schematically illustrate two configurations of another example apparatus in accordance with certain implementations described herein;
  • FIGs. 6A and 6B schematically illustrate two configurations of another example apparatus in accordance with certain implementations described herein.
  • FIG. 7 is a flow diagram of an example method in accordance with certain implementations described herein.
  • Certain implementations described herein provide an apparatus configured to directly measure a magnetic retention force between the apparatus and an implanted device beneath tissue of a recipient.
  • the apparatus can be configured to receive information regarding the implanted device and to provide information to the recipient and/or a medical practitioner indicative of: the magnetic retention force, the skin flap thickness of the tissue between the apparatus and the implanted device, and/or an identification of a suitable retention magnet to be used in an external device to be placed over implanted device to hold the external device on the recipient’s body.
  • certain implementations described herein provide small (e.g., handheld), relatively inexpensive, and simple devices compatible for intuitive and reliable use by recipients and/or practitioners in a clinical setting to provide sufficiently accurate information.
  • implantable or non-implantable stimulation system or device e.g., implantable or non-implantable auditory prosthesis device or system
  • implantable or non-implantable auditory prosthesis device or system configured to provide stimulation signals and/or medicament dosages to a portion of the recipient’s body in response to received information and/or control signals
  • implantable sensor prostheses e.g., implantable stimulation system; implantable medicament administration system
  • implantable sensor system e.g., implantable sensor prostheses; implantable stimulation system; implantable medicament administration system
  • Implementations can include any type of medical device that can utilize the teachings detailed herein and/or variations thereof.
  • certain implementations are described herein in the context of auditory prosthesis devices, certain other implementations are compatible in the context of other types of devices or systems that provide a wide range of therapeutic benefits to recipients, patients, or other users.
  • other sensory prosthesis systems that are configured to evoke other types of neural or sensory (e.g., sight, tactile, smell, taste) percepts are compatible with certain implementations described herein, including but are not limited to: vestibular devices (e.g., vestibular implants), visual devices (e.g., bionic eyes), visual prostheses (e.g., retinal implants), somatosensory implants, and chemosensory implants.
  • teachings detailed herein and/or variations thereof can be utilized in other types of implantable medical devices beyond sensory prostheses.
  • apparatus and methods disclosed herein and/or variations thereof can be used with one or more of the following: sensors; cardiac pacemakers; drug delivery systems; defibrillators; functional electrical stimulation devices; catheters; brain implants; seizure devices (e.g., devices for monitoring and/or treating epileptic events); sleep apnea devices; electroporation; pain relief devices; etc.
  • Implementations can include any type of medical system that can utilize the teachings detailed herein and/or variations thereof.
  • an implantable transducer assembly including but not limited to: electro-acoustic electrical/acoustic systems, cochlear implant devices, implantable hearing aid devices, middle ear implant devices, bone conduction devices (e.g., active bone conduction devices; passive bone conduction devices, percutaneous bone conduction devices; transcutaneous bone conduction devices), Direct Acoustic Cochlear Implant (DACI), middle ear transducer (MET), electro-acoustic implant devices, other types of auditory prosthesis devices, and/or combinations or variations thereof, or any other suitable hearing prosthesis system with or without one or more external components.
  • DACI Direct Acoustic Cochlear Implant
  • MET middle ear transducer
  • electro-acoustic implant devices other types of auditory prosthesis devices, and/or combinations or variations thereof, or any other suitable hearing prosthesis system with or without one or more external components.
  • Implementations can include any type of auditory prosthesis that can utilize the teachings detailed herein and/or variations thereof. Certain such implementations can be referred to as “partially implantable,” “semi-implantable,” “mostly implantable,” “fully implantable,” or “totally implantable” auditory prostheses. In some implementations, the teachings detailed herein and/or variations thereof can be utilized in other types of prostheses beyond auditory prostheses.
  • FIG. 1A is a perspective view of an example cochlear implant auditory prosthesis 100 implanted in a recipient in accordance with certain implementations described herein.
  • the example auditory prosthesis 100 is shown in FIG. 1A as comprising an implanted stimulator unit 120 and a microphone assembly 124 that is external to the recipient (e.g., a partially implantable cochlear implant).
  • An example auditory prosthesis 100 e.g., a totally implantable cochlear implant; a mostly implantable cochlear implant
  • the example cochlear implant auditory prosthesis 100 of FIG. 1 A can be in conjunction with a reservoir of liquid medicament as described herein.
  • the recipient has an outer ear 101, a middle ear 105, and an inner ear 107.
  • the outer ear 101 comprises an auricle 110 and an ear canal 102.
  • An acoustic pressure or sound wave 103 is collected by the auricle 110 and is channeled into and through the ear canal 102.
  • a tympanic membrane 104 Disposed across the distal end of the ear canal 102 is a tympanic membrane 104 which vibrates in response to the sound wave 103.
  • This vibration is coupled to oval window or fenestra ovalis 112 through three bones of middle ear 105, collectively referred to as the ossicles 106 and comprising the malleus 108, the incus 109, and the stapes 111.
  • the bones 108, 109, and 111 of the middle ear 105 serve to filter and amplify the sound wave 103, causing the oval window 112 to articulate, or vibrate in response to vibration of the tympanic membrane 104.
  • This vibration sets up waves of fluid motion of the perilymph within cochlea 140.
  • Such fluid motion activates tiny hair cells (not shown) inside the cochlea 140. Activation of the hair cells causes appropriate nerve impulses to be generated and transferred through the spiral ganglion cells (not shown) and auditory nerve 114 to the brain (also not shown) where they are perceived as sound.
  • the example auditory prosthesis 100 comprises one or more components which are temporarily or permanently implanted in the recipient.
  • the example auditory prosthesis 100 is shown in FIG. 1A with an external component 142 which is directly or indirectly attached to the recipient’s body, and an internal component 144 which is temporarily or permanently implanted in the recipient (e.g., positioned in a recess of the temporal bone adjacent auricle 110 of the recipient).
  • the external component 142 typically comprises one or more sound input elements (e.g., an external microphone 124) for detecting sound, a sound processing unit 126 (e.g., disposed in a Behind-The-Ear unit), a power source (not shown), and an external transmitter unit 128.
  • the external transmitter unit 128 comprises an external coil 130 (e.g., a wire antenna coil comprising multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire) and, preferably, a magnet (not shown) secured directly or indirectly to the external coil 130.
  • the external coil 130 of the external transmitter unit 128 is part of an inductive radio frequency (RF) communication link with the internal component 144.
  • the sound processing unit 126 processes the output of the microphone 124 that is positioned externally to the recipient’s body, in the depicted implementation, by the recipient’s auricle 110.
  • the sound processing unit 126 processes the output of the microphone 124 and generates encoded signals, sometimes referred to herein as encoded data signals, which are provided to the external transmitter unit 128 (e.g., via a cable).
  • the sound processing unit 126 can utilize digital processing techniques to provide frequency shaping, amplification, compression, and other signal conditioning, including conditioning based on recipient-specific fitting parameters.
  • the power source of the external component 142 is configured to provide power to the auditory prosthesis 100, where the auditory prosthesis 100 includes a battery (e.g., located in the internal component 144, or disposed in a separate implanted location) that is recharged by the power provided from the external component 142 (e.g., via a transcutaneous energy transfer link).
  • the transcutaneous energy transfer link is used to transfer power and/or data to the internal component 144 of the auditory prosthesis 100.
  • Various types of energy transfer such as infrared (IR), electromagnetic, capacitive, and inductive transfer, may be used to transfer the power and/or data from the external component 142 to the internal component 144.
  • the internal component 144 comprises an internal receiver unit 132, a stimulator unit 120, and an elongate electrode assembly 118.
  • the internal receiver unit 132 and the stimulator unit 120 are hermetically sealed within a biocompatible housing.
  • the internal receiver unit 132 comprises an internal coil 136 (e.g., a wire antenna coil comprising multiple turns of electrically insulated single-strand or multistrand platinum or gold wire), and preferably, a magnet (also not shown) fixed relative to the internal coil 136.
  • the internal receiver unit 132 and the stimulator unit 120 are hermetically sealed within a biocompatible housing, sometimes collectively referred to as a stimulator/receiver unit.
  • the internal coil 136 receives power and/or data signals from the external coil 130 via a transcutaneous energy transfer link (e.g., an inductive RF link).
  • the stimulator unit 120 generates electrical stimulation signals based on the data signals, and the stimulation signals are delivered to the recipient via the elongate electrode assembly 118.
  • the elongate electrode assembly 118 has a proximal end connected to the stimulator unit 120, and a distal end implanted in the cochlea 140.
  • the electrode assembly 118 extends from the stimulator unit 120 to the cochlea 140 through the mastoid bone 119.
  • the electrode assembly 118 may be implanted at least in the basal region 116, and sometimes further.
  • the electrode assembly 118 may extend towards apical end of cochlea 140, referred to as cochlea apex 134.
  • the electrode assembly 118 may be inserted into the cochlea 140 via a cochleostomy 122.
  • a cochleostomy may be formed through the round window 121, the oval window 112, the promontory 123, or through an apical turn 147 of the cochlea 140.
  • the elongate electrode assembly 118 comprises a longitudinally aligned and distally extending array 146 of contacts or electrodes 148, sometimes referred to as electrode or contact array 146 herein, disposed along a length thereof.
  • the electrode array 146 can be disposed on the electrode assembly 118, in most practical applications, the electrode array 146 is integrated into the electrode assembly 118 (e.g., the electrode array 146 is disposed in the electrode assembly 118).
  • the stimulator unit 120 generates stimulation signals which are applied by the electrodes 148 to the cochlea 140, thereby stimulating the auditory nerve 114.
  • FIG. 1 A schematically illustrates an auditory prosthesis 100 utilizing an external component 142 comprising an external microphone 124, an external sound processing unit 126, and an external power source
  • one or more of the microphone 124, sound processing unit 126, and power source are implantable on or within the recipient (e.g., within the internal component 144).
  • the auditory prosthesis 100 can have each of the microphone 124, sound processing unit 126, and power source implantable on or within the recipient (e.g., encapsulated within a biocompatible assembly located subcutaneously), and can be referred to as a totally implantable cochlear implant (“TICI”).
  • TICI totally implantable cochlear implant
  • the auditory prosthesis 100 can have most components of the cochlear implant (e.g., excluding the microphone, which can be an in-the-ear-canal microphone) implantable on or within the recipient, and can be referred to as a mostly implantable cochlear implant (“MICI”).
  • MICI implantable cochlear implant
  • FIG. IB schematically illustrates a perspective view of an example fully implantable auditory prosthesis 200 (e.g., fully implantable middle ear implant or totally implantable acoustic system), implanted in a recipient, utilizing an acoustic actuator in accordance with certain implementations described herein.
  • the example auditory prosthesis 200 of FIG. IB comprises a biocompatible implantable assembly 202 (e.g., comprising an implantable capsule) located subcutaneously (e.g., beneath the recipient’s skin and on a recipient's skull). While FIG.
  • IB schematically illustrates an example implantable assembly 202 comprising a microphone, in other example auditory prostheses 200, a pendant microphone can be used (e.g., connected to the implantable assembly 202 by a cable).
  • the implantable assembly 202 includes a signal receiver 204 (e.g., comprising a coil element) and an acoustic transducer 206 (e.g., a microphone comprising a diaphragm and an electret or piezoelectric transducer) that is positioned to receive acoustic signals through the recipient’s overlying tissue.
  • the implantable assembly 202 may further be utilized to house a number of components of the fully implantable auditory prosthesis 200.
  • the implantable assembly 202 can include an energy storage device and a signal processor (e.g., a sound processing unit).
  • Various additional processing logic and/or circuitry components can also be included in the implantable assembly 202 as a matter of design choice.
  • the signal processor of the implantable assembly 202 is in operative communication (e.g., electrically interconnected via a wire 208) with an actuator 210 (e.g., comprising a transducer configured to generate mechanical vibrations in response to electrical signals from the signal processor).
  • the example auditory prosthesis 100, 200 shown in FIGs. 1A and IB can comprise an implantable microphone assembly, such as the microphone assembly 206 shown in FIG. IB.
  • the signal processor of the implantable assembly 202 can be in operative communication (e.g., electrically interconnected via a wire) with the microphone assembly 206 and the stimulator unit 120 of the main implantable component.
  • at least one of the microphone assembly 206 and the signal processor e.g., a sound processing unit
  • the actuator 210 of the example auditory prosthesis 200 shown in FIG. IB is supportably connected to a positioning system 212, which in turn, is connected to a bone anchor 214 mounted in the recipient's mastoid bone (e.g., via a hole drilled through the skull).
  • the actuator 210 includes a connection apparatus 216 for connecting the actuator 210 to the ossicles 106 of the recipient. In a connected state, the connection apparatus 216 provides a communication path for acoustic stimulation of the ossicles 106 (e.g., through transmission of vibrations from the actuator 210 to the incus 109).
  • ambient acoustic signals e.g., ambient sound
  • a signal processor within the implantable assembly 202 processes the signals to provide a processed audio drive signal via wire 208 to the actuator 210.
  • the signal processor may utilize digital processing techniques to provide frequency shaping, amplification, compression, and other signal conditioning, including conditioning based on recipient-specific fitting parameters.
  • the audio drive signal causes the actuator 210 to transmit vibrations at acoustic frequencies to the connection apparatus 216 to affect the desired sound sensation via mechanical stimulation of the incus 109 of the recipient.
  • the subcutaneously implantable microphone assembly 202 is configured to respond to auditory signals (e.g., sound; pressure variations in an audible frequency range) by generating output signals (e.g., electrical signals; optical signals; electromagnetic signals) indicative of the auditory signals received by the microphone assembly 202, and these output signals are used by the auditory prosthesis 100, 200 to generate stimulation signals which are provided to the recipient’s auditory system.
  • auditory signals e.g., sound; pressure variations in an audible frequency range
  • output signals e.g., electrical signals; optical signals; electromagnetic signals
  • the diaphragm of an implantable microphone assembly 202 can be configured to provide higher sensitivity than are external non-implantable microphone assemblies.
  • the diaphragm of an implantable microphone assembly 202 can be configured to be more robust and/or larger than diaphragms for external non-implantable microphone assemblies.
  • the example auditory prostheses 100 shown in FIG. 1 A utilizes an external microphone 124 and the auditory prosthesis 200 shown in FIG. IB utilizes an implantable microphone assembly 206 comprising a subcutaneously implantable acoustic transducer.
  • the auditory prosthesis 100 utilizes one or more implanted microphone assemblies on or within the recipient.
  • the auditory prosthesis 200 utilizes one or more microphone assemblies that are positioned external to the recipient and/or that are implanted on or within the recipient, and utilizes one or more acoustic transducers (e.g., actuator 210) that are implanted on or within the recipient.
  • an external microphone assembly can be used to supplement an implantable microphone assembly of the auditory prosthesis 100, 200.
  • teachings detailed herein and/or variations thereof can be utilized with any type of external or implantable microphone arrangement, and the acoustic transducers shown in FIGs. 1A and IB are merely illustrative.
  • FIG. 1C schematically illustrates a side cross-sectional view of an example transcutaneous system 300 comprising an implantable component 310 and an external component 320.
  • the transcutaneous system 300 can comprise an auditory prosthesis 100, 200 in which the implantable component 310 comprises one or more active elements (e.g., stimulator unit 120; assembly 202; vibrating actuator; not shown in FIG. 1C) configured to deliver stimuli to the recipient’s body and the external component 320 (e.g., external component 142) can comprise components (e.g., external microphone 124; sound processing unit 126; a power source; external transmitter unit 128) worn outside the recipient’s body (e.g., on the recipient’s body) and configured to operate with the implantable component 310.
  • active elements e.g., stimulator unit 120; assembly 202; vibrating actuator; not shown in FIG. 1C
  • the external component 320 e.g., external component 142
  • components e.g., external microphone 124; sound processing unit 126; a
  • the implantable component 310 can comprise at least one implantable housing 312 configured to be positioned beneath tissue 330 of the recipient’s body (e.g., beneath the skin, fat, and/or muscular layers) and above a bone (e.g., skull) in a portion of the recipient’s body (e.g., the head).
  • tissue 330 of the recipient’s body e.g., beneath the skin, fat, and/or muscular layers
  • a bone e.g., skull
  • the at least one implantable housing 312 can contain at least one internal coil (not shown; e.g., a planar electrically conductive wire with multiple windings; multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire having a substantially circular, rectangular, spiral, or oval shape or other shape) and at least one internal magnetic (e.g., ferromagnetic; ferrimagnetic; permanent magnet) material 316 (e.g., disk; plate).
  • the at least one internal magnetic material 316 can be configured to establish a magnetic attraction 318 between the implantable component 310 and the external component 320 sufficient to hold the external component 320 against an outer surface of the tissue 330.
  • the at least one implantable housing 312 can comprise a first portion configured to contain the at least one internal magnetic material 316 and the at least one internal coil and a second portion configured to contain the one or more active elements, or the at least one implantable housing 312 can comprise a single housing portion configured to contain the at least one internal magnetic material 316, the at least one internal coil, and the one or more active elements.
  • the external component 320 can comprise an external housing 322 configured to be positioned on an outer surface 332 of the tissue 330 (e.g., skin surface) and contains at least one external coil (not shown; e.g., a planar electrically conductive wire with multiple windings) and at least one external magnetic (e.g., ferromagnetic; ferrimagnetic; permanent magnet) material 326 (e.g., disk; plate).
  • at least one external coil not shown; e.g., a planar electrically conductive wire with multiple windings
  • at least one external magnetic (e.g., ferromagnetic; ferrimagnetic; permanent magnet) material 326 e.g., disk; plate.
  • the at least one external coil can be configured to be in wireless electrical communication (e.g., wirelessly receiving and/or transmitting data and/or control signals and/or wirelessly transmitting power to the implantable component 310 via at least one radio-frequency link and/or inductive coupling) with the at least one internal coil when the external component 320 is positioned on the tissue 330 of the recipient above the internal component 310.
  • the at least one external magnetic material 326 can be configured to establish the magnetic attraction 318 between the implantable component 310 and the external component 320 (e.g., along a longitudinal axis 328 extending from the at least one external magnetic material 326 to the at least one internal magnetic material 316) sufficient to hold the external component 320 against the outer surface 332 of the tissue 330.
  • the coupling coefficient between the at least one internal coil and the at least one external coil is inversely dependent on the distance between the at least one internal coil and the at least one external coil.
  • the strength of the magnetic attraction between the at least one internal magnetic material 316 and the at least one external magnetic material 326 is inversely dependent on the distance between the at least one internal magnetic material 316 and the at least one external magnetic material 326.
  • the at least one external coil can be configured to be as close as possible to the at least one internal coil (e.g., a distance as close as possible to the thickness of the tissue 330 between the at least one implantable housing 312 and the external housing 322).
  • the at least one external magnetic material 326 can be configured to be as close as possible to the at least one internal magnetic material 316 (e.g., a distance as close as possible to the thickness of the tissue 330 between the at least one implantable housing 312 and the external housing 322).
  • the thickness of the tissue 330 between the at least one implantable housing 312 and the external housing 322 can be referred to as the skin flap thickness (SFT), as denoted in FIG. 1C.
  • SFT skin flap thickness
  • the SFT for auditory prosthesis systems can be, for example, in a range of 2 millimeters to 12 millimeters, and the SFT for other types of systems can have a larger maximum value.
  • the SFT can also change under various physiological situations (e.g., weight loss or gain by recipient; growth of the recipient).
  • Information regarding the SFT of the recipient and/or the strength of the magnetic attraction achievable using the implantable component 310 of the recipient and potentially available external components 320 and/or external magnetic materials 326 can be helpful for selecting an appropriate external component 320 and/or at least one external magnetic material 326 for the transcutaneous system 300.
  • FIGs. 2A and 2B schematically illustrate cross-sectional views of two example apparatus 400 in accordance with certain implementations described herein.
  • the example apparatus 400 can be configured to be positioned outside a recipient’s body at a location at which an external portion of a transcutaneous system (e.g., external component 320) can be positioned, instead of the apparatus 400.
  • the apparatus 400 of FIGs. 2A or 2B can be positioned on an outer surface 332 of the recipient’s tissue 330 such that the apparatus 400 at least partially overlies an implantable component 310 of the transcutaneous auditory prosthesis system 300.
  • the location at which the apparatus 400 is positioned can be substantially the same as the location at which the external component 320 of the transcutaneous auditory prosthesis system 300 is to be positioned, instead of the apparatus 400 (e.g., such that the external component 320 is in wireless communication with the implantable component 310 and is retained at the location by the magnetic attraction 318 between the implantable component 310 and the external component 320).
  • the apparatus 400 does not have the functionality of an external component 320 configured to operate in conjunction with the implanted component 310 during operation of the implanted component 310.
  • the implanted component 310 can comprise a cochlear implant configured to operate in conjunction with an external component 320 comprising a sound processor
  • the apparatus 400 can be configured to be placed over the implanted component 310 (e.g., magnetically retained by the cochlear implant) and, while not having the functionality of the sound processor of the external component 320, can provide information (e.g., evaluate the actual SFT value of the recipient’s tissue 330) useful for informing a selection of a magnetic configuration for an external component 320 comprising a sound processor to be used with the cochlear implant.
  • the apparatus 400 can be configured to be used with multiple types of implanted components 310 (e.g., multiple types of second elements 340; at least two of axial magnets, diametric magnets, and angled four pole magnets) or configured to be used with only a single type of implanted component 310 (e.g., single type of second element 340; only one of axial magnets, diametric magnets, and angled four pole magnets).
  • the apparatus 400 can be configured to be used with implanted components 310 of only a single manufacturer or configured to be used with implanted components 310 of multiple manufacturers.
  • the apparatus 400 does have the functionality of an external component 320 configured to operate in conjunction with the implanted component 310 during operation of the implanted component 310.
  • the implanted component 310 can comprise a cochlear implant configured to operate in conjunction with an external component 320 comprising a sound processor, and the apparatus 400 can be such an external component 320 configured to be placed over the implanted component 310 (e.g., magnetically retained by the cochlear implant), to operate in conjunction with the implanted component 310 to provide a hearing percept to the recipient, and to generate information (e.g., evaluate the actual SFT value of the recipient’s tissue 330) useful for informing a selection of a magnetic configuration for the apparatus 400.
  • information e.g., evaluate the actual SFT value of the recipient’s tissue 330
  • the apparatus 400 comprises a housing 410 having an external surface 412 configured to be placed on the outer surface 332 (e.g., skin surface) of the recipient.
  • the apparatus 400 further comprises a ferromagnetic or ferrimagnetic first element 420 (e.g., comprising at least one external magnetic material 326) configured to, upon the housing 410 being placed on the outer surface 332, generate an attractive magnetic force 422 with a ferromagnetic or ferrimagnetic second element 340 (e.g., comprising at least one internal magnetic material 316) within an implanted device 350 (implantable component 310; medical implant) beneath the outer surface 332.
  • a ferromagnetic or ferrimagnetic first element 420 e.g., comprising at least one external magnetic material 326
  • a ferromagnetic or ferrimagnetic second element 340 e.g., comprising at least one internal magnetic material 316
  • the apparatus 400 further comprises a sensor 430 within the housing 410 and in communication (e.g., mechanical communication) with the first element 420.
  • the sensor 430 is configured to receive information regarding the second element 340 and to generate an indication of at least one characteristic of an interaction between the first element 420 and the second element 340.
  • the apparatus 400 is configured to approximate a mass, size, and/or shape of an external portion of a transcutaneous system (e.g., external component 320 of a transcutaneous auditory prosthesis system 300).
  • the attractive magnetic force 422 can be configured to approximate a magnetic force between the implantable component 310 and an external component 320 to be placed at the location instead of the apparatus 400 (e.g., in a range less than 1.1 N).
  • the attractive magnetic force 422 between the apparatus 400 and the implanted component 310 can be configured to approximate the corresponding magnetic forces for one or more (e.g., each) of the multiple configurations.
  • the apparatus 400 can be smaller and/or lighter than the external portion of the transcutaneous system, and the attractive magnetic forces 422 can be weaker than the magnetic forces of at least one configuration of the at least one magnet of the external portion of the transcutaneous system.
  • the housing 410 comprises a first housing portion 414 containing the first element 420 and a second housing portion 416, the first housing portion 414 configured to move relative to the second housing portion 416 (e.g., the first housing portion 414 in mechanical communication with the second housing portion 416 via only the sensor 430).
  • the external surface 412 is part of the first housing portion 414 (see, e.g., FIG. 2A), while in certain other implementations, the external surface 412 is part of the second housing portion 416 (see, e.g., FIG. 2B).
  • the first housing portion 414 comprises at least one biocompatible material that is substantially transparent to magnetic flux such that the first housing portion 414 does not substantially interfere with the attractive magnetic force 422 between the first element 420 and the second element 340.
  • the material of the first housing portion 414 can comprise plastic (e.g., PEEK), silicone, or ceramic (e.g., zirconium oxide).
  • the second housing portion 416 comprises at least one biocompatible material (e.g., the same as or different from the material of the first housing portion 414), examples of which include, but are not limited to: plastic (e.g., PEEK); silicone; ceramic (e.g., zirconium oxide); non-magnetic metals (e.g., titanium).
  • biocompatible material e.g., the same as or different from the material of the first housing portion 414
  • the housing 410 can have a width (e.g., along a lateral direction substantially parallel to the recipient’s skin) less than or equal to 40 millimeters (e.g., in a range of 15 millimeters to 35 millimeters; in a range of 25 millimeters to 35 millimeters; in a range of less than 30 millimeters; in a range of 15 millimeters to 30 millimeters).
  • a width e.g., along a lateral direction substantially parallel to the recipient’s skin
  • 40 millimeters e.g., in a range of 15 millimeters to 35 millimeters; in a range of 25 millimeters to 35 millimeters; in a range of less than 30 millimeters; in a range of 15 millimeters to 30 millimeters.
  • each of the first element 420 and the second element 340 comprises at least one magnet (e.g., permanent magnet; electromagnet) configured to generate the attractive magnetic force 422 between the first element 420 and the second element 340.
  • the first element 420 and the second element 340 can each comprise at least one ferromagnetic material selected from the group consisting of: iron, nickel, cobalt, and steel.
  • the first element 420 can have a permanent first magnetization comprising a first dipole magnetic moment 424 (e.g., a dipole magnet; an axially magnetized (axial) magnet, a diametrically magnetized (diametric) magnet) or multiple first dipole magnetic moments 424 (e.g., a multipole magnetic moment; having two or more portions with different dipole magnetic moments or magnetizations; an angled four pole magnet).
  • a first dipole magnetic moment 424 e.g., a dipole magnet; an axially magnetized (axial) magnet, a diametrically magnetized (diametric) magnet
  • multiple first dipole magnetic moments 424 e.g., a multipole magnetic moment; having two or more portions with different dipole magnetic moments or magnetizations; an angled four pole magnet.
  • the second element 340 can have a permanent second magnetization comprising a second dipole magnetic moment 344 (e.g., a dipole magnet; an axial magnet, a diametric magnet) or multiple second dipole magnetic moments 344 (e.g., a multiple magnetic moment; having two or more portions with different dipole magnetic moments or magnetizations; an angled four pole magnet).
  • the first magnetization is configured to interact with the second magnetization to generate the attractive magnetic force 422.
  • the first element 420 has a first width (e.g., in a direction substantially parallel to the outer surface 332 of the recipient’s tissue 330) and a first height (e.g., substantially perpendicular to the outer surface 332).
  • the first element 420 can have a substantially cylindrical shape with a cross-section (e.g., circular; elliptical; square; rectangular; polygonal; geometric; irregular; symmetric; non-symmetric) with straight, curved, or irregular sides, a rectangular prism or a hexagonal prism shape, symmetric shape, non-symmetric shape, or other shapes.
  • the first element 420 can be configured to have an orientation during operation of the apparatus 400 such that the first diameter Di is substantially parallel to the outer surface 332 and the first height Hi is substantially perpendicular to the outer surface 332.
  • the first diameter Di is in a range of 10 millimeters to 14 millimeters
  • the first height Hi is in a range of 0.8 millimeter to 8 millimeters (e.g., selected to provide sufficient magnetic attractive force across the SFT of the recipient).
  • FIGs. 3A-3G schematically illustrate various example types and combinations of the first element 420 and the second element 340 in accordance with certain implementations described herein.
  • the first and second elements 420, 340 are of substantially equal size and shape with one another, while in certain other implementations, the first and second elements 420, 340 have substantially different sizes and/or shapes.
  • the first and second elements 420, 340 each including multiple magnetic elements or other types of magnets, and/or the first and second elements 420, 340 being other combinations of magnet types, sizes, and/or shapes are also compatible with certain implementations described herein.
  • the first element 420 at least partially overlies the second element 340.
  • the first element 420 can self-position (e.g., self-center) relative to the second element 340 of the implanted device 350.
  • each of the first and second elements 420, 340 comprises an axial magnet having corresponding first and second dipole magnetic moments 424, 344 that are substantially parallel to one another.
  • each of the first and second elements 420, 340 comprises a diametric magnet having corresponding first and second dipole magnetic moments 424, 344 that are substantially anti -parallel to one another (e.g., substantially parallel and pointing in substantially opposite directions).
  • each of the first and second elements 420, 340 comprises an angled four pole magnet having corresponding first and second dipole magnetic moments 424, 344.
  • the first element 420 comprises a diametric magnet and the second element 340 comprises an angled four pole magnet
  • the first element 420 comprises an angled four pole magnet and the second element 340 comprises a diametric magnet
  • the first element 420 comprises an axial magnet and the second element 340 comprises a diametric magnet
  • the first element 420 comprises an axial magnet and the second element 340 comprises an angled four pole magnet. While FIGs.
  • 3C and 3E show each of the two first dipole magnetic moments 424 having a non-zero angle relative to the longitudinal axis of the first element 420, the two first dipole magnetic moments 424 of the angled four pole magnet can be substantially parallel to the longitudinal axis of the first element 420 (e.g., one of the first dipole magnetic moments 424 pointing upwards and the other of the first dipole magnetic moments 424 pointing downward).
  • FIGs. 1 shows that shows that the two first dipole magnetic moments 424 having a non-zero angle relative to the longitudinal axis of the first element 420
  • the two first dipole magnetic moments 424 of the angled four pole magnet can be substantially parallel to the longitudinal axis of the first element 420 (e.g., one of the first dipole magnetic moments 424 pointing upwards and the other of the first dipole magnetic moments 424 pointing downward).
  • 3C, 3D, and 3G show each of the two second dipole magnetic moments 344 having a non-zero angle relative to the longitudinal axis of the second element 340, the two second dipole magnetic moments 344 of the angled four pole magnet can be substantially parallel to the longitudinal axis of the second element 340 (e.g., one of the second dipole magnetic moments 344 pointing upwards and the other of the second dipole magnetic moments 344 pointing downward).
  • the first element 420 comprises an axial magnet and can be used for evaluating at least one characteristic of the interaction between the first element 420 and a second element 340 that comprises an axial magnet (e.g., FIG. 3A), a diametric magnet (e.g., FIG. 3F), or an angled four pole magnet (e.g., FIG. 3G).
  • the first element 420 comprises a diametric magnet and can be used for evaluating at least one characteristic of the interaction between the first element 420 and a second element 340 that comprises a diametric magnet (e.g., FIG. 3B) or an angled four pole magnet (e.g., FIG. 3D).
  • the first element 420 comprises an angled four pole magnet and can be used for evaluating at least one characteristic of the interaction between the first element 420 and a second element 340 that comprises an angled four pole magnet (e.g., FIG. 3C) or a diametric magnet (e.g., FIG. 3E).
  • the attractive magnetic force 422 generated by the first element 420 with the second element 340 is dependent upon the relative positions of the first element 420 and the second element 340.
  • the attractive magnetic force 422 can be strongest with the first element 420 substantially overlying the second element 340.
  • a maximum magnitude of the attractive magnetic force 422 can correspond to a maximum overlap of the first element 420 over the second element 340 (see, e.g., FIGs. 3A- 3E which have zero lateral displacement between the centers of the first element 420 and the second element 340).
  • a maximum magnitude of the attractive magnetic force 422 can correspond to a non-zero lateral displacement between the centers of the first element 420 and the second element 340 (e.g., for first and second elements 420, 340 of comparable widths, the lateral displacement can be substantially equal to one -half the width; see, e.g., FIGs. 3F-3G).
  • the first element 420 is configured to freely rotate about an axis (e.g., the longitudinal axis 328) in response to the resultant magnetic forces to substantially align the at least one dipole magnetic moment 424 with the at least one second dipole magnetic moment 344.
  • an axis e.g., the longitudinal axis 328
  • the first element 420 can be configured to rotate within and relative to the first housing portion 414.
  • the first element 420 and the first housing portion 414 can be configured to rotate together.
  • the first dipole magnetic moment 424 can be substantially anti-parallel to the second dipole magnetic moment 344 of the diametric second element 340 (see, e.g., FIG. 3B) or substantially anti-parallel to the vector sum of the second dipole magnetic moments 344 of the angled four pole second element 340 (see, e.g., FIG. 3D).
  • the vector sum of the first dipole magnetic moments 424 can be substantially anti-parallel to the second dipole magnetic moment 344 of the diametric second element 340 (see, e.g., FIG. 3E) or substantially anti-parallel to the vector sum of the second dipole magnetic moments 344 of the angled four pole second element 340 (see, e.g., FIG. 3C).
  • the senor 430 (e.g., gauge) comprises a transducer 432 and circuitry 434 in communication (e.g., wired; wireless) with the transducer 432.
  • the transducer 432 can be in mechanical communication with the first element 420 (e.g., with the first housing portion 414 containing the first element 420) and with the housing 410 (e.g., with the second housing portion 416). While FIGs. 2A-2B show the transducer 432 located directly between the first housing portion 414 and the second housing portion 416, the transducer 432 can be located in other positions.
  • the transducer 432 can be configured to generate measurement signals (e.g., electric signals) in response to the attractive magnetic force 422.
  • the transducer 432 can comprise a load cell configured to generate the sensor signal in response to tension (e.g., strain) within the transducer 432 due to the attractive magnetic force 422 pulling the first element 420 away from the housing 410 (e.g., pulling the first housing portion 414 away from the second housing portion 416 in a direction substantially perpendicular to the outer surface 332 of the tissue 330).
  • the transducer 432 can comprise a piezoelectric element configured to generate the sensor signal in response to a displacement of the first housing portion 414 relative to the second housing portion 416 due to the attractive magnetic force 422.
  • Other types of transducers 432 are also compatible with certain implementations described herein.
  • the circuitry 434 comprises a processor (e.g., microprocessor, application-specific integrated circuit, generalized integrated circuit programmed by software with computer executable instructions, microelectronic circuitry, microcontroller).
  • the processor can be in operative communication with at least one storage device (e.g., at least one tangible or non-transitory computer readable storage medium; read only memory; random access memory; flash memory) of the circuitry 434 or separate from the apparatus 400 and in operative communication with the circuitry 434.
  • the at least one storage device can be configured to store information (e.g., data, commands, values of one or more parameters) accessible by the processor during operation.
  • the at least one storage device can be encoded with software (e.g., a computer program downloaded as an application) comprising computer executable instructions for instructing the processor (e.g., executable data access logic, evaluation logic, and/or information outputting logic).
  • the processor executes the instructions of the software to provide functionality as described herein.
  • the circuitry 434 can further comprise at least one input interface in operative communication with the processor.
  • the at least one input interface can be configured to receive input signals (e.g., from the recipient; from the medical practitioner) indicative of the information regarding the second element 340.
  • Examples of the at least one input interface include but are not limited to: rotatable knobs (e.g., connected to potentiometers); buttons; switches; touchscreen; microphone and voice-responsive circuitry.
  • the at least one input interface can comprise an antenna configured to receive wireless input signals (e.g., Bluetooth signals; WiFi signals) from a device separate from the apparatus 400 (e.g., smartphone, tablet, computing device).
  • the circuitry 434 can further comprise at least one output interface in operative communication with the processor.
  • the at least one output interface can be configured to provide output signals (e.g., to the recipient; to the medical practitioner) indicative of the indication of the at least one characteristic of the interaction between the first element 420 and the second element 340.
  • Examples of the at least one output interface include but are not limited to: a speaker configured to generate audio signals; an LED or LCD display configured to generate visual signals (e.g., colored lights, images, or alphanumeric characters visible through a transparent portion 418 of the housing 410, such as a window or opening); a haptic motor configured to generate vibrations or other tactile signals.
  • the at least one output interface can comprise an antenna configured to transmit wireless output signals (e.g., Bluetooth signals; WiFi signals) to a device separate from the apparatus 400 (e.g., smartphone, tablet, computing device) to display the indication.
  • the circuitry 434 can further comprise a user interface (e.g., touchscreen; transceiver antenna) configured to operate as both the at least one input interface and the at least one output interface.
  • the circuitry 434 is configured to receive the measurement signals generated by the transducer 432 (e.g., strain measurements from a load cell; displacement measurements from a piezoelectric element) and in response to the measurement signals, generate the sensor signal (e.g., electric signal) indicative of the attractive magnetic force 422 (e.g., indicative of a magnitude of the attractive magnetic force 422 in a direction substantially perpendicular to the external surface 412).
  • the circuitry 434 can access a lookup table (e.g., stored by the at least one storage device) or a conversion algorithm configured to convert the tension and/or displacement measurement signals into the sensor signal indicative of the attractive magnetic force 422.
  • the circuitry 434 can use the tension and/or displacement measurement signals as the sensor signal.
  • the external surface 412 is part of the first housing portion 414 (see, e.g., FIG. 2A)
  • the attractive magnetic force 422 pulling the first element 420 towards the second element 340 is counteracted by an outward force from the tissue 330 on the first housing portion 414 containing the first element 420.
  • the apparatus 400 remains stationary, there is no tension within the transducer 432 or displacement of the first housing portion 414 relative to the second housing portion 416, as reflected by the tension and/or displacement measurement signals.
  • the transducer 432 can continue to generate the tension and/or displacement measurement signals.
  • the outward force on the first element 420 from the tissue 330 is reduced while the attractive magnetic force 422 on the first element 420 remains substantially unchanged, and the tension and/or the displacement increases as reflected by the tension and/or displacement measurement signals.
  • the circuitry 434 can be configured to detect the maximal value of the tension and/or displacement measurement signals during the manual pulling and to convert the maximal value into a measured magnitude of the attractive magnetic force 422.
  • the attractive magnetic force 422 pulling the first element 420 towards the second element 340 generates tension within the transducer 432 and/or displacement of the first housing portion 414 relative to the second housing portion 416 (e.g., the outward force from the tissue 330 is applied to the second housing portion 416, not the first housing portion 414).
  • the apparatus 400 remains stationary, with the transducer 432 generating tension and/or displacement measurement signals indicative of the attractive magnetic force 422 (e.g., without having to manually pull the second housing portion 416 away from the tissue 330).
  • the transducer 432 can continue to generate the tension and/or displacement measurement signals while the apparatus 400 is manually slid laterally along the outer surface 332 of the tissue 330 to find an optimal location at which the first element 420 and the second element 340 generate a maximal value of the tension and/or displacement corresponding to a maximum magnitude of the attractive magnetic force 422.
  • the circuitry 434 can be configured to detect the maximal value of the tension and/or displacement during the manual sliding and to convert the maximal value into a measured magnitude of the attractive magnetic force 422.
  • the circuitry 434 is configured to detect the type of second element 340 (e.g., axial, diametric, or angled four pole magnet) using the measurement values obtained during the manual sliding of the apparatus 400 along the outer surface 332 of the tissue 330.
  • the circuitry 434 of the sensor 430 is configured to receive information regarding the second element 340 (e.g., from the at least one input interface).
  • the information can include the size, strength, and/or type of the magnet of the second element 340 (e.g., identifying the second element 340 as an axial magnet, a diametric magnet, or an angled four pole magnet).
  • the information can include the model number, serial number, and/or other identifying indicia of the implanted device 350, and the circuitry 434 can be configured to convert the received information into the information regarding the second element 340 to be used for generating the indication of the at least one characteristic of the interaction between the first element 420 and the second element 340.
  • the information can be obtained from medical records of the recipient, from programming software, from x-ray information of the implanted device 350, or passing a magnet (e.g., compass) over the implanted device 350.
  • the circuitry 434 is configured to receive only information regarding the second element 340 and/or the implanted device 350 of a predetermined manufacturer (e.g., a predetermined acoustic prosthesis manufacturer) and to provide the indication of the at least one characteristic of the interaction that is relevant to only the products of the predetermined manufacturer.
  • the circuitry 434 is configured to use the information regarding the second element 340 and the sensor signal to generate the indication of the at least one characteristic of the interaction between the first element 420 and the second element 340.
  • the circuitry 434 can be configured to access at least one lookup table (e.g., stored by the at least one storage device) or a set of conversion algorithms for translating the sensor signal indicative of the attractive magnetic force 422 measured by the sensor 430 into the at least one characteristic of the interaction between the first element 420 and the second element 340.
  • the circuitry 434 can access a lookup table portion or conversion algorithm corresponding to the second element 340 and to use the accessed lookup table portion or conversion algorithm with the sensor signal to generate the indication of the at least one characteristic.
  • the at least one characteristic comprises at least one attribute (e.g., magnitude; direction) of the attractive magnetic force 422 (e.g., magnetic retention force) generated by the interaction of the first element 420 with the second element 340.
  • the circuitry 434 can be configured to use the information regarding the second element 340 to convert the measurement signals from the sensor 430 into a magnitude and/or direction of the attractive magnetic force 422.
  • the at least one characteristic comprises a thickness of tissue between the implanted device 350 and the external surface 412 of the housing 410 (e.g., an estimation of the actual SFT of the recipient’s tissue 330 beneath the apparatus 400).
  • the information received by the circuitry 434 can identify the second element 340 of the implanted device 350 and can be used by the circuitry 434 to access the predetermined magnetic configuration and/or strength of the second element 340 (e.g., from the at least one storage device).
  • the circuitry 434 can also access the predetermined magnetic configuration and/or strength of the first element 420 (e.g., from the at least one storage device).
  • the circuitry 434 can use the magnetic configurations and/or strengths of the first and second elements 420, 340 and the sensor signal indicative of the measured attractive magnetic force 422 between the first and second elements 420, 340 to determine (e.g., calculate) the distance between the first and second elements 420, 340.
  • the circuitry 434 can further access the predetermined thicknesses of the portions of the housing 410 and the housing 312 of the implanted device 350 between the first and second elements 420, 340 to determine (e.g., calculate) the SFT of the recipient’s tissue 330 beneath the apparatus 400.
  • the at least one characteristic comprises at least one attribute (e.g., size; shape; magnetic strength) of a ferromagnetic or ferrimagnetic third element of an external device to be placed overlaying the implanted device 350, instead of the apparatus 400.
  • the third element can comprise at least one external magnetic material 326 (e.g., at least one retention magnet) of an external component 320 of the transcutaneous auditory prosthesis system 300 to be placed overlaying an implantable component 310 of the transcutaneous auditory prosthesis system 300, instead of the apparatus 400.
  • the third element can be estimated to generate an attractive magnetic force with the second element 340 of the implanted device 350 sufficient to retain (e.g., having sufficient magnitude in a direction substantially perpendicular to the external surface 412 to hold) the external device on the particular recipient’s body.
  • the external device is compatible for use with a finite set of magnetic configurations (e.g., a set of retention magnets having differing strengths from one another), and the at least one characteristic identifies (e.g., selects) a magnetic configuration from the set of magnetic configurations, the identified magnetic configuration estimated to be sufficient to hold the external device on the particular recipient’s body.
  • the information received by the circuitry 434 can identify the second element 340 of the implanted device 350 and can be used by the circuitry 434 to access the predetermined magnetic configuration and/or strength of the second element 340 (e.g., from the at least one storage device).
  • the circuitry 434 can also access the predetermined magnetic configuration and/or strength of the first element 420 (e.g., from the at least one storage device).
  • the circuitry 434 can use the magnetic configurations and/or strengths of the first and second elements 420, 340 and the sensor signal indicative of the measured attractive magnetic force 422 between the first and second elements 420, 340 to identify (e.g., select) a magnetic configuration for the third element of the external device to be placed overlaying the implanted device 350, instead of the apparatus 400.
  • FIG. 4 schematically illustrates another example apparatus 500 in accordance with certain implementations described herein.
  • the example apparatus 500 is configured to be used either in a first configuration with the external surface 412 as part of the first housing portion 414, the external surface 412 configured to contact the recipient’s body (see, e.g., FIG. 2A) or in a second configuration with the external surface 412 separate from the first housing portion 414 (see, e.g., FIG. 2B).
  • the example apparatus 500 comprises a housing 410 in which the first housing portion 414 extends beyond the second housing portion 416, a first element 420 within the first housing portion 414, and a sensor 430 within the housing 410 and in mechanical communication with the first housing portion 414 and the second housing portion 416.
  • the example apparatus 500 further comprises a housing extension 510 (e.g., spacer) configured to fit onto the second housing portion 416 such that the first housing portion 414 does not extend beyond the housing extension 510.
  • the housing extension 510 can comprise at least one biocompatible material (e.g., the same as or different from the material of the first and/or second housing portions 414, 416), examples of which include, but are not limited to: plastic (e.g., PEEK); silicone; ceramic (e.g., zirconium oxide); non-magnetic metals.
  • the housing extension 510 and the second housing portion 416 can comprise mating protrusions and recesses configured to reversibly affix the housing extension 510 onto the second housing portion 416 (e.g., such that the housing extension 510 can be repeatedly attached and detached from the second housing portion 416 without damage to either the housing extension 510 or the second housing portion 416).
  • the external surface 412 is part of the first housing portion 414 and the apparatus 400 can be used as described herein with regard to FIG. 2A.
  • the external surface 412 is part of the housing extension 510 and the apparatus 500 can be used as described herein with regard to FIG. 2B.
  • the senor 430 is configured to receive information regarding whether the housing extension 510 is affixed to the second housing portion 416 or not (e.g., attached to or detached from other portions of the apparatus 400) and to generate the indication of the at least one characteristic of the interaction between the first element 420 and the second element 340 accordingly.
  • FIGs. 5A and 5B schematically illustrate two configurations of another example apparatus 600 in accordance with certain implementations described herein.
  • the example apparatus 600 is configured to be used either in a first configuration with the external surface 412 as part of the first housing portion 414 (see, e.g., FIG. 2A) or with the external surface 412 separate from the first housing portion 414 (see, e.g., FIG. 2B).
  • the example apparatus 600 comprises a housing 410 comprising a first housing portion 414 containing the first element 420, a second housing portion 416 comprising a movable third portion 610 and a fourth portion 620, and a sensor 430 within the housing 410 and in mechanical communication with the first housing portion 414 and the movable third portion 610.
  • the movable third portion 610 is configured to be controllably moved relative to the fourth portion 620 between at least a first position (see, e.g., FIG. 5A) and a second position different from the first position (see, e.g., FIG. 5B) such that the transducer 432 of the sensor 430 is controllably moved relative to the external surface 412.
  • the external surface 412 is part of the first housing portion 414 and the apparatus 400 can be used as described herein with regard to FIG. 2A.
  • the external surface 412 is part of the second housing portion 416 and the apparatus 500 can be used as described herein with regard to FIG. 2B.
  • the senor 430 is configured to receive information regarding whether the movable third portion 610 is in the first position or the second position and to generate the indication of the at least one characteristic of the interaction between the first element 420 and the second element 340 accordingly (e.g., at least partially in response to the information regarding the position of the movable third portion 610).
  • the movable third portion 610 is in mechanical communication with the fourth portion 620 and is configured to controllably adjust a relative position of the movable third portion 610 relative to the fourth portion 620 along an axis (e.g., the longitudinal axis 328) substantially perpendicular to the external surface 412.
  • the movable third portion 610 can be linearly slid along the longitudinal axis 328 to move the first housing portion 414 and the first element 420 relative to the fourth portion 620.
  • the movable third portion 610 can be rotated along a screw thread that encircles the longitudinal axis 328 and is between the movable third portion 610 and the fourth portion 620 (e.g., screwing and unscrewing the movable third portion 610 into and out of the fourth portion 620).
  • the movable third portion 610 comprises a ratchet mechanism (e.g., ratchet stop) to facilitate consistent and reliable (e.g., repeatable) measurements.
  • Other motions and/or mechanisms of the movable third portion 610 are also compatible with certain implementations described herein (e.g., different sized spacers inserted/removed from between the movable third portion 610 and the fourth portion 620; different receptacles at different distances from the external surface 412, the movable third portion 610 configured to be inserted into a selected receptacle) to move the first housing portion 414 relative to the external surface 412.
  • FIGs. 6A and 6B schematically illustrate two configurations of another example apparatus 700 in accordance with certain implementations described herein.
  • the apparatus 700 is configured to be flipped between the two configurations.
  • the example apparatus 700 comprises a housing 410 comprising two first housing portions 414a,b each containing a corresponding first element 420a, b, a second housing portion 416 comprising a toggle lock 710 (e.g., latch), and a sensor 430 within the housing 410 and in mechanical communication with each of the two first housing portion 414a,b.
  • a toggle lock 710 e.g., latch
  • a sensor 430 within the housing 410 and in mechanical communication with each of the two first housing portion 414a,b.
  • One first housing portion 414a extends past the second housing portion 416 and the other first housing portion 414b is recessed relative to the second housing portion 416.
  • the two first elements 420a, b can be substantially the same as one another or the two first elements 420a, b can have substantially different sizes, shapes, magnetic types, and/or magnetic strengths from one another.
  • one of the two first elements 420a, b can be configured to be used with a first type of second element 340 (e.g., one of an axial, diametric, and angled four pole magnet) and the other of the two first elements 420a, b can be configured to be used with a second type of second element 340 different from the first type (e.g., another of an axial, diametric, and angled four pole magnet).
  • the user knowing the type of the second element 340 can choose which of the two first elements 420a, b to place adjacent to the recipient’s tissue.
  • the toggle lock 710 is configured to be controllably switched to be in either a first position (see, e.g., FIG. 6A) or in a second position (see, e.g., FIG. 6B).
  • the toggle lock 710 In the first position, the toggle lock 710 is mechanically engaged with the first housing portion 414b, such that the first element 420b is fixed relative to the housing 410.
  • the apparatus 700 with the toggle lock 710 in the first position is configured to allow the first element 420a to interact with the second element 340 while the external surface 412a contacts the recipient’s body and to be used as described herein with regard to FIG. 2A.
  • the toggle lock 710 In the second position, the toggle lock 710 is mechanically engaged with the first housing portion 414a, such that the first element 420a is fixed relative to the housing 410.
  • the apparatus 700 with the toggle lock 710 in the second position is configured to allow the first element 420b to interact with the second element 340 while the external surface 412b contacts the recipient’s body and to be used as described herein with regard to FIG. 2B.
  • FIG. 7 is a flow diagram of an example method 800 in accordance with certain implementations described herein. While the method 800 is described by referring to some of the structures of the example apparatus 400, 500, 600, 700 of FIGs. 2A-2B, 3A-3G, 4, 5A-5B, and 6A-6B, other apparatus and systems with other configurations of components can also be used to perform the method 800 in accordance with certain implementations described herein.
  • the method 800 is performed using an apparatus 400, 500, 600, 700 that does not have the functionality of an external device (e.g., external component 320) that is a part of, or operates in conjunction with, an implanted device 350 (e.g., implanted component 310) during operation of the implanted device.
  • the external device can be configured to wirelessly communicate power and/or data with the implanted device 350 (e.g., to wirelessly transmit power and/or data to the implanted device 350; to wirelessly receive data from the implanted device 350).
  • the method 800 is performed using an apparatus 400, 500, 600, 700 that does have the functionality of the external device.
  • the method 800 comprises placing an apparatus (e.g., apparatus 400, 500, 600, 700) on a recipient’s body over a portion of tissue 330 overlaying the implanted device (e.g., implantable component 310), the apparatus comprising a first magnet (e.g., first element 420) generating a first attractive magnetic force (e.g., attractive magnetic force 422) with the implanted device.
  • an apparatus e.g., apparatus 400, 500, 600, 700
  • a recipient e.g., apparatus 400, 500, 600, 700
  • the apparatus comprising a first magnet (e.g., first element 420) generating a first attractive magnetic force (e.g., attractive magnetic force 422) with the implanted device.
  • a first magnet e.g., first element 420
  • attractive magnetic force e.g., attractive magnetic force 422
  • the method 800 further comprises accessing first information indicative of a magnetic configuration of the implanted device 350.
  • the first information can include the size, strength, and/or type of the magnet within the implanted device 350 (e.g., identifying the magnet as an axial magnet, a diametric magnet, or an angled four pole magnet); model number, serial number, and/or other identifying indicia of the implanted device 350.
  • the method 800 can further comprise converting the received information into the first information regarding the magnetic configuration of the implanted device 350.
  • the method 800 further comprises using the apparatus to generate second information indicative of at least one characteristic of an interaction between the implanted device 350 and the apparatus.
  • the apparatus can generate the second information after the apparatus has been pulled away from the recipient’s body (see, e.g., FIG. 2A) or the apparatus can generate the second information while the apparatus is on the recipient’s body (see, e.g., FIG. 2B).
  • Using the apparatus to generate the second information can comprise using a gauge (e.g., sensor 430) of the apparatus to generate measurement signals (e.g., electric signals) in response to tension (e.g., strain) and/or displacement within the gauge due to the first attractive magnetic force.
  • Generating the second information can further comprise communicating the measurement signals to circuitry of the apparatus and/or to circuitry of a display device (e.g., smartphone; smart tablet; computer) separate from the apparatus.
  • a display device e.g., smartphone; smart tablet; computer
  • the at least one characteristic can include a magnitude of the first attractive magnetic force (e.g., in a direction substantially perpendicular to the recipient’s skin).
  • the at least one characteristic can include a thickness of tissue between the implanted device 350 and the apparatus.
  • the at least one characteristic can include an estimation of the second magnet 326 configured to interact with the implanted device 350 so as to generate sufficient magnetic force to hold the external device 320 on the recipient’s body.
  • the method 800 further comprises, in response to the first and second information, selecting (e.g., recommending) a second magnet 326 from a finite set of magnets (e.g., permanent magnets) compatible for insertion within the external device configured to interact with the implanted device 350.
  • selecting the second magnet 326 can be performed by circuitry of the apparatus, circuitry of a display device separate from the apparatus, or by a user that receives the information (e.g., from a display of the apparatus or of the display device separate from and in communication with the circuitry of the apparatus).
  • selecting the second magnet 326 further comprises selecting a position of the second magnet 326 within the external device (e.g., distance of the second magnet 326 from an outside surface of the external device).
  • the method 800 further comprises removing a magnet from the external device and inserting the selected second magnet into the external device.
  • the display of the apparatus can indicate whether the selected second magnet generates a magnetic force strength sufficient to hold the apparatus on the recipient’s body (e.g., a green LED that is illuminated when the magnetic force strength is sufficient and that is not illuminated when the magnetic force strength is insufficient).
  • the method 800 further comprises removing the apparatus from the location over the portion of the tissue 330 overlying the implanted device 350 (e.g., subsequent to using the apparatus to generate the information) and placing the external device containing the second magnet 326 at the location instead of the apparatus.
  • the second magnet can generate a second attractive magnetic force with the implanted device 350 that magnetically holds the external device on the recipient’s body with the external device in wireless communication with the implanted device 350 (e.g., such that the external device and the implanted device can be used to provide a hearing percept to the recipient).
  • the method 800 further comprises using the apparatus in wireless communication with the implantable component 310.
  • the method 800 can further comprise accessing previously-stored information indicative of the at least one characteristic of the interaction between the implanted device 350 and the apparatus at a previous time, comparing the second information to the previously-stored information, and evaluating whether a substantial change has occurred (e.g., whether the second element 340 has weakened; whether the SFT has increased or decreased) since the previous time.
  • a substantial change e.g., whether the second element 340 has weakened; whether the SFT has increased or decreased
  • the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by ⁇ 10 degrees, by ⁇ 5 degrees, by ⁇ 2 degrees, by ⁇ 1 degree, or by ⁇ 0.1 degree
  • the terms “generally perpendicular” and “substantially perpendicular” refer to a value, amount, or characteristic that departs from exactly perpendicular by ⁇ 10 degrees, by ⁇ 5 degrees, by ⁇ 2 degrees, by ⁇ 1 degree, or by ⁇ 0.1 degree.
  • the ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” less than,” “between,” and the like includes the number recited.
  • ordinal adjectives e.g., first, second, etc.
  • the ordinal adjective are used merely as labels to distinguish one element from another (e.g., one signal from another or one circuit from one another), and the ordinal adjective is not used to denote an order of these elements or of their use.

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Otolaryngology (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Acoustics & Sound (AREA)
  • Signal Processing (AREA)
  • Neurosurgery (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un appareil comprenant un boîtier dont la surface externe est configurée pour être placée sur la surface de la peau d'un receveur. L'appareil comprend en outre un premier élément ferromagnétique ou ferrimagnétique configuré pour, lorsque le boîtier est placé sur la surface de la peau, générer une force magnétique attractive avec un second élément ferromagnétique ou ferrimagnétique à l'intérieur d'un dispositif implanté sous la surface de la peau. L'appareil comprend en outre un capteur à l'intérieur du boîtier et en communication avec le premier élément. Le capteur est configuré pour recevoir des informations concernant le second élément et pour générer une indication d'au moins une caractéristique d'une interaction entre les premier et second éléments.
PCT/IB2024/055300 2023-07-05 2024-05-30 Système et procédé de mesure directe de force de rétention Pending WO2025008686A1 (fr)

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US63/511,975 2023-07-05

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100292759A1 (en) * 2005-03-24 2010-11-18 Hahn Tae W Magnetic field sensor for magnetically-coupled medical implant devices
US20170086002A1 (en) * 2015-09-18 2017-03-23 Med-El Elektromedizinische Geraete Gmbh Bone Conduction Transducer System with Adjustable Retention Force
US20180146309A1 (en) * 2016-11-18 2018-05-24 Gn Hearing A/S Embedded antenna
US20180352349A1 (en) * 2017-06-02 2018-12-06 Cochlear Limited Controlled fitting of an implantable medical device
US20210268175A1 (en) * 2020-02-27 2021-09-02 Medtronic, Inc. External-magnetically controlled access to implanted fluid pathway

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100292759A1 (en) * 2005-03-24 2010-11-18 Hahn Tae W Magnetic field sensor for magnetically-coupled medical implant devices
US20170086002A1 (en) * 2015-09-18 2017-03-23 Med-El Elektromedizinische Geraete Gmbh Bone Conduction Transducer System with Adjustable Retention Force
US20180146309A1 (en) * 2016-11-18 2018-05-24 Gn Hearing A/S Embedded antenna
US20180352349A1 (en) * 2017-06-02 2018-12-06 Cochlear Limited Controlled fitting of an implantable medical device
US20210268175A1 (en) * 2020-02-27 2021-09-02 Medtronic, Inc. External-magnetically controlled access to implanted fluid pathway

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