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WO2025149854A1 - Surveillance d'électrode - Google Patents

Surveillance d'électrode

Info

Publication number
WO2025149854A1
WO2025149854A1 PCT/IB2025/050047 IB2025050047W WO2025149854A1 WO 2025149854 A1 WO2025149854 A1 WO 2025149854A1 IB 2025050047 W IB2025050047 W IB 2025050047W WO 2025149854 A1 WO2025149854 A1 WO 2025149854A1
Authority
WO
WIPO (PCT)
Prior art keywords
impedance
electrode
surface area
implantable
stimulating electrodes
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/IB2025/050047
Other languages
English (en)
Inventor
Vivian Wang
Martin Joseph Svehla
Giedrius BRAZICKAS
Nick Charles Kendall PAWSEY
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 WO2025149854A1 publication Critical patent/WO2025149854A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • 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
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/30—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • 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
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36135—Control systems using physiological parameters
    • A61N1/3614—Control systems using physiological parameters based on impedance measurement
    • 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
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36142—Control systems for improving safety
    • 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
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
    • A61N2001/083—Monitoring integrity of contacts, e.g. by impedance measurement

Definitions

  • FIG. 2D is a top view of the stimulating assembly and the electrode of FIG. 2C at the time of the new clinical session;
  • FIG. 6 is a flowchart of a method according to an example embodiment
  • an exemplary implantable medical device includes one or more electrodes that are used to deliver electrical stimulation (current signals) to a recipient.
  • the implantable medical device is configured to obtain/capture data associated with one or more electrode (“electrode data”) and use the electrode data to determine a level of wear, dissolution, or corrosion of at least one of the electrodes.
  • the data is obtained in situ (e.g., in a non-invasive manner while the electrodes are implanted in the recipient).
  • the implantable medical device is a cochlear implant.
  • the obtained electrode data can include impedance data (impedances), or other electrical data (e.g., voltages, currents, etc.) that can be used to derive (e.g., calculate, estimate, etc.) impedances.
  • the reduction in surface area of an electrode can be due to various factors, including but not limited to wear, dissolution, and/or corrosion of the material forming the tissue-facing surface of the electrode.
  • the reduction in surface area can linear or non-linear (e.g., the surface area could change in a non-linear way due to increasing stimulation charge densities).
  • an implantable medical device could be configured to perform in vivo analysis of data associated with one or more electrodes and, accordingly, determine an “amount” of wear, dissolution, or corrosion, in terms of an amount of electrode material that has been lost, and/or an amount of electrode material that is remaining.
  • the amount of electrode material can be represented by a surface area (e.g., based on length, width, depth/thickness, or a combination thereof).
  • the obtained data can be used to determine a “rate” of wear, dissolution, or corrosion, in terms of how fast the electrode is losing its effective surface area.
  • the electrode data can represent a current physical state of the electrode, a future/predicted physical state of the electrode, a current rate of wear, dissolution, or corrosion, a future/predicted rate of wear, dissolution, or corrosion.
  • the electrode data can represent, or may be used to derive (calculate, estimate), a projected lifespan of the electrode (e.g., in terms of months/years of useful life remaining, and/or a date (e.g., month/year) corresponding to the end of useful life for the electrode.
  • remedial actions can be taken, as needed or desired.
  • the one or more remedial actions can include, but are not limited to, identifying an adjustment of a stimulation parameter or operational setting of the medical device to change a future rate of wear, dissolution, or corrosion, instructing the recipient to use the medical device in a different manner, etc.
  • the system and techniques described herein provide a method to detect the loss of electrode surface area so that, for example, stimulation parameters or operational settings can be adjusted to minimize further loss due to wear, dissolution, and/or corrosion, effectively avoiding the complete failure of the electrode channel (which may otherwise occur in the absence of any adjustments to stimulation parameters, operational settings, or other preventative actions).
  • the system and techniques described herein can also provide users (e.g., implant recipients, clinicians, etc.) with a greater degree of assurance that the electrodes will not fail (or at least would not fail without providing any warning to that effect).
  • the system and techniques described herein can enable implant recipients to enjoy the benefits of certain functions without them being limited due to the uncertainty in predicting electrode wear, dissolution, and/or corrosion that results in a reduction of usable electrode surface area, as will be explained in detail below.
  • the techniques presented herein are primarily described with reference to a specific device in the form of a cochlear implant system. However, it is to be appreciated that the techniques presented herein may also be partially or fully implemented by any of a number of different types of devices, including hearing devices, implantable medical devices, wearable devices (e.g., smartwatches), consumer electronic devices (e.g., mobile phones), etc.
  • hearing device is to be broadly construed as any device that delivers sound signals to a user in any form, including in the form of acoustical stimulation, mechanical stimulation, electrical stimulation, etc.
  • a hearing device can be a device for use by a hearing -impaired person (e.g., hearing aids, middle ear auditory prostheses, bone conduction devices, direct acoustic stimulators, electro-acoustic hearing prostheses, auditory brainstem stimulators, bimodal hearing prostheses, bilateral hearing prostheses, dedicated tinnitus therapy devices, tinnitus therapy device systems, combinations or variations thereof, etc.) or a device for use by a person with normal hearing (e.g., consumer devices that provide audio streaming, consumer headphones, earphones, and other listening devices).
  • a hearing -impaired person e.g., hearing aids, middle ear auditory prostheses, bone conduction devices, direct acoustic stimulators, electro-acoustic hearing prostheses, auditory brainstem stimulators, bimodal hearing prostheses, bilateral hearing prostheses, dedicated tinnitus therapy devices, tinnitus therapy device systems, combinations or variations thereof, etc
  • the techniques presented herein can be implemented by, or used in conjunction with, various implantable medical devices, such as vestibular devices (e.g., vestibular implants), visual devices (i.e., bionic eyes), sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, seizure devices (e.g., devices for monitoring and/or treating epileptic events), sleep apnea devices, electroporation devices, etc.
  • various implantable medical devices such as vestibular devices (e.g., vestibular implants), visual devices (i.e., bionic eyes), sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, seizure devices (e.g., devices for monitoring and/or treating epileptic events), sleep apnea devices, electroporation devices, etc.
  • FIGs. 1A-1D illustrates an example cochlear implant system 102 with which aspects of the techniques presented herein can be implemented.
  • the cochlear implant system 102 comprises an external component 104 that is configured to be directly or indirectly attached to the body of the user, and an intemal/implantable component 112 that is configured to be implanted in or worn on the head of the user.
  • the implantable component 112 is sometimes referred to as a “cochlear implant.”
  • FIG. 1A illustrates the cochlear implant 112 implanted in the head 154 of a user
  • FIG. IB is a schematic drawing of the external component 104 worn on the head 154 of the user.
  • FIG. 1C is another schematic view of the cochlear implant system 102
  • FIG. ID illustrates further details of the cochlear implant system 102.
  • FIGs. 1A-1D will generally be described together.
  • the external component 104 comprises a sound processing unit 106, an external coil 108, and generally, a magnet fixed relative to the external coil 108.
  • the cochlear implant 112 includes an implantable coil 114, an implant body 134, and an elongate stimulating assembly 116 configured to be implanted in the user’s cochlea.
  • the sound processing unit 106 is an off-the-ear (OTE) sound processing unit, sometimes referred to herein as an OTE component, which is configured to send data and power to the implantable component 112.
  • OTE off-the-ear
  • an OTE sound processing unit is a component having a generally cylindrically shaped housing 111 and which is configured to be magnetically coupled to the user’s head 154 (e.g., includes an integrated external magnet 150 configured to be magnetically coupled to an intemal/implantable magnet 152 in the implantable component 112).
  • the OTE sound processing unit 106 also includes an integrated external (headpiece) coil 108 (the external coil 108) that is configured to be inductively coupled to the implantable coil 114.
  • stimulating assembly 116 is configured to be at least partially implanted in the user’s cochlea.
  • Stimulating assembly 116 includes a plurality of longitudinally spaced intra-cochlear electrical stimulating contacts (electrodes) 144 that collectively form a contact array (electrode array) 146 for delivery of electrical stimulation (current) to the recipient’s cochlea.
  • Stimulating assembly 116 extends through an opening in the recipient’s cochlea (e.g., cochleostomy, the round window, etc.) and has a proximal end connected to stimulator unit 142 via lead region 136 and a hermetic feedthrough (not shown in FIG. ID).
  • the cochlear implant system 102 includes the external coil 108 and the implantable coil 114.
  • the external magnet 150 is fixed relative to the external coil 108 and the intemal/implantable magnet 152 is fixed relative to the implantable coil 114.
  • the external magnet 150 and the intemal/implantable magnet 152 fixed relative to the external coil 108 and the intemal/implantable coil 114, respectively, facilitate the operational alignment of the external coil 108 with the implantable coil 114.
  • This operational alignment of the coils enables the external component 104 to transmit data and power to the implantable component 112 via a closely-coupled wireless link 148 formed between the external coil 108 with the implantable coil 114.
  • the closely-coupled wireless link 148 is a radio frequency (RF) link.
  • RF radio frequency
  • various other types of energy transfer such as infrared (IR), electromagnetic, capacitive and inductive transfer, may be used to transfer the power and/or data from an external component to an implantable component and, as such, FIG. ID illustrates only one example arrangement.
  • output control signals are provided to the RF transceiver 122, which transcutaneously transfers the output control signals (e.g., in an encoded manner) to the implantable component 112 via external coil 108 and implantable coil 114. That is, the output control signals (stimulation signals) are received at the RF interface circuitry 140 via implantable coil 114 and provided to the stimulator unit 142.
  • the stimulator unit 142 is configured to utilize the output control signals to generate electrical stimulation signals (e.g., current signals) for delivery to the user’s cochlea via one or more of the stimulating contacts (electrodes) 144.
  • the cochlear implant 112 receives processed sound signals from the sound processing unit 106.
  • the cochlear implant 112 is configured to capture and process sound signals for use in electrically stimulating the user’s auditory nerve cells.
  • an example embodiment of the cochlear implant 112 can include a plurality of implantable sound sensors 165(1), 165(2) that collectively form a sensor array 160, and an implantable sound processing module 158.
  • the implantable sound processing module 158 may comprise, for example, one or more processors and a memory device (memory) that includes sound processing logic.
  • the implantable sound sensors 165(1), 165(2) of the sensor array 160 are configured to detect/capture input sound signals 166 (e.g., acoustic sound signals, vibrations, etc.), which are provided to the implantable sound processing module 158.
  • the implantable sound processing module 158 is configured to convert received input sound signals 166 (received at one or more of the implantable sound sensors 165(1), 165(2)) into output control signals 156 for use in stimulating the first ear of a recipient or user (i.e., the implantable sound processing module 158 is configured to perform sound processing operations).
  • the one or more processors e.g., processing element(s) implementing firmware, software, etc.
  • implantable sound processing module 158 are configured to execute sound processing logic in memory to convert the received input sound signals 166 into output control signals 156 that are provided to the stimulator unit 142.
  • the stimulator unit 142 is configured to utilize the output control signals 156 to generate electrical stimulation signals (e.g., current signals) for delivery to the user’s cochlea, thereby bypassing the absent or defective hair cells that normally transduce acoustic vibrations into neural activity.
  • the memory 184 can store, among other things, instructions executable by the processing unit 183 to implement applications or cause performance of operations described herein, as well as other data.
  • the memory 184 can be volatile memory (e.g., RAM), non-volatile memory (e.g., ROM), or combinations thereof.
  • the memory 184 can include transitory memory or non-transitory memory.
  • the memory 184 can also include one or more removable or non-removable storage devices.
  • the memory 184 can include random access memory (RAM), read only memory (ROM), EEPROM (Electronically-Erasable Programmable Read-Only Memory), flash memory, optical disc storage, magnetic storage, solid state storage, or any other memory media usable to store information for later access.
  • the memory 184 can include wired media such as a wired network or direct-wired connection, and wireless media such as acoustic, RF, infrared and other wireless media or combinations thereof.
  • the memory 184 comprises logic 185 that, when executed, enables the processing unit 183 to perform aspects of the techniques presented.
  • the external computing device 110 further includes a network adapter 186, one or more input devices 187, and one or more output devices 188.
  • the external computing device 110 can include other components, such as a system bus, component interfaces, a graphics system, a power source (e.g., a battery), among other components.
  • the network adapter 186 is a component of the external computing device 110 that provides network access (e.g., access to at least one network 189).
  • the network adapter 186 can provide wired or wireless network access and can support one or more of a variety of communication technologies and protocols, such as ETHERNET, cellular, BLUETOOTH, near-field communication, and RF (Radiofrequency), among others.
  • the network adapter 186 can include one or more antennas and associated components configured for wireless communication according to one or more wireless communication technologies and protocols.
  • the one or more input devices 187 are devices over which the external computing device 110 receives input from a user.
  • the one or more input devices 187 can include physically- actuatable user-interface elements (e.g., buttons, switches, or dials), a keypad, keyboard, mouse, touchscreen, and voice input devices, among other input devices that can accept user input.
  • the one or more output devices 188 are devices by which the computing device 110 is able to provide output to a user.
  • the output devices 188 can include a display 190 (e.g., a liquid crystal display (LCD)) and one or more speakers 191, among other output devices for presentation of visual or audible information to the recipient, a clinician, an audiologist, or other user.
  • a display 190 e.g., a liquid crystal display (LCD)
  • speakers 191 among other output devices for presentation of visual or audible information to the recipient, a clinician, an audiologist, or other user.
  • the external computing device 110 shown in FIG. IE is merely illustrative and that aspects of the techniques presented herein can be implemented at a number of different types of systems/devices including any combination of hardware, software, and/or firmware configured to perform the functions described herein.
  • the external computing device 110 can be a personal computer (e.g., a desktop or laptop computer), a hand-held device (e.g., a tablet computer), a mobile device (e.g., a smartphone), a surgical system, and/or any other electronic device having the capabilities to perform the associated operations described elsewhere herein.
  • Electrostimulating electrodes undergo the gradual loss of material as they are used for stimulation. If severe corrosion occurs, a reduced surface area and increased charge density will further accelerate the corrosion process of this electrode. A significant reduction in electrode surface area may lead to stimulation pulses exceeding the Shannon limit, as this safety risk is related to charge density, which can result in damage to nerve cells. The significant loss of electrode material can eventually lead to failure of the stimulation channel and thereby impact the recipient’s hearing performance outcomes. If multiple electrodes fail, the efficacy of the implantable medical devices would be severely impacted and the device may even need to be explanted. In summary, severe corrosion of electrodes can ultimately impact the reliability and longevity of the implantable medical device.
  • cochlear implant electrodes are expected to deliver stimulation over the lifetime of the recipient, which can potentially last up to 20 years, 30 years, 50 years or more from initial implantation (depending on the device and its usage). Wear, dissolution, and/or corrosion of one or more of the electrodes can occur over these time periods (or in shorter periods of time in some instances), resulting in the reduction of utility/function of the electrode, and in some cases, resulting in the eventual loss of utility/function.
  • the smaller the size of the electrode, and the smaller the surface area exposed to the ambient environment in particular the higher/faster the rate of wear, dissolution, or corrosion, and the sooner the electrode will experience a level of wear, dissolution, or corrosion that negatively impacts functionality.
  • an increase in charge density of the electrode can result in an increased rate of wear, dissolution, or corrosion, and/or a shortened utilitarian life expectancy of the electrode (i.e., the faster the electrode array reaches the end of its useful life).
  • the implantable portion of the medical device can apply multipolar stimulation from the electrodes, which can result in higher charge levels for a given electrode (e.g., compared to monopolar stimulation).
  • Multipolar stimulation can be used to focus the stimulation and improve hearing performance, and can also improve channel independence, spectral resolution, and speech understanding.
  • the use of multipolar stimulation can further add to the statistical likelihood and/or actual occurrence of premature electrode wear, dissolution, or corrosion (e.g., in comparison to monopolar stimulation).
  • “Four Point Impedance” Four-point impedance is measured by utilizing four adjacent intracochlear electrodes and applying current between the two outer electrodes while measuring the voltage differential between the inner two electrodes.
  • the four adjacent electrodes can run from basal to apical ends of the electrode array to provide frequency-specific electrophysiological information along the cochlea.
  • An increase in total four-point impedances is associated with cochlea bleeding/inflammation and fibrosis development that can lead to delayed increases in hearing thresholds following cochlear implantation.
  • four-point impedances have been found to rise within 24 hours of cochlear implantation and 3 months postoperatively, particularly in the basal region, aligning with the natural timeline of acute and chronic inflammatory responses. Individual inflammatory response times can vary across individual recipients.
  • an increase in postoperative four-point impedances could be preceding or occurring concurrently with an increase in acoustic hearing thresholds.
  • Trans impedance Matrix Trans impedance Matrix: Trans impedance matrices are measured in the same mode as monopolar (MP1+2) described above. It expands the information collected by assessing impedance at numerous time points during the pulse. This allows the impedance measures to be analyzed into sub-components of “access impedance” and “polarization impedance.” Increasing access impedance and stable polarization impedance is associated with hearing threshold changes, which indicates the utility of this measure as a biomarker for acoustic hearing changes.
  • FIG. 2A is an example of an initial clinical session 205, in which an external device 210 has a connection 248 to the implant and the stimulating assembly 216.
  • the electrode 244 shown in FIG. 2A may be a new/virgin electrode, or an electrode that is still relatively early in its lifecycle, for example, without any corrosion, wear, dissolution, etc. (or with only a minimal amount thereof).
  • FIG. 2B is a top view of the stimulating assembly 216 and the electrode 244 of FIG. 2A at the time of the initial clinical session 205.
  • the electrode 244 has an initial surface area (Ai) at the time of the initial clinical session 205.
  • the initial surface area (Ai) may be defined by one or more of a first length (LI), a first width (Wl), and/or a first depth (DI) (i.e., first thickness).
  • the initial surface area (Ai) can be defined by a combination of LI, Wl, and DI.
  • Ai can be estimated or derived from only one or two of LI, Wl, and/or DI.
  • the external device 210 obtains initial impedance measurements x (Zi) for corresponding electrodes of the stimulating assembly 216 during the initial clinical session 205 of FIGs. 2A and 2B.
  • FIG. 2C is an example of a new clinical session 215, in which the electrode 244 has corroded (worn, dissolved, eroded, etc.) and has a new surface area (An), which is a reduced surface area in comparison to the initial surface area (Ai).
  • the electrode 244 shown in FIG. 2C may be an electrode that is somewhere in the middle of its lifecycle, or nearing the end of its lifecycle, for example.
  • FIG. 2D is a top view of the stimulating assembly 216 and the electrode 244 of FIG. 2C at the time of the new clinical session 215.
  • the electrode 244 now has a new surface area (An) at the time of the new clinical session 215.
  • the new surface area (An) may be defined by one or more of a second length (L2), a second width (W2), and/or a second depth (D2) (i.e., second thickness).
  • the new surface area (An) can represent a combination of L2, W2, and D2.
  • An may represent only one or two of L2, W2, and/or D2.
  • the external device 210 obtains new impedance measurements y (Zn) for corresponding electrodes of the stimulating assembly 216 during the new clinical session 215 of FIGs. 2C and 2D.
  • FIG. 2G is an example of electrode “corrosion,” in which the electrode 244 can have a thin layer of foreign material at least partially covering the upper surface thereof, such as a film 247a that has formed thereon in one example, or rust 247b in another example, or some other build-up of foreign material.
  • a “corrosion status” can be determined (e.g., to indicate an amount of the electrode surface area that is corroded, or an amount of uncorroded electrode surface area that is remaining) based on analysis of the impedance measurements in relation to reference/baseline impedance measurements.
  • FIG. 3 is a flowchart of a method 300 for determining a change in surface area based on a change in impedance, according to an example embodiment.
  • the method 300 includes obtaining an initial impedance (Zi) for one or more electrodes implanted in a recipient during an initial clinical session at a first time.
  • the method 300 includes storing the initial impedance (Zi) and an initial surface area (Ai) for the one or more electrodes, as reference/baseline values.
  • the method 300 includes obtaining a new impedance (Zn) for the one or more electrodes implanted in the recipient during a new clinical session at a second time.
  • method 300 includes deriving a new surface area (An) for the one or more electrodes, based on the initial surface area (Ai) and a difference between the initial impedance (Zi) and the new impedance (Zn).
  • a functionality can be added to the clinical software to track the history of impedance measurements, and also to notify a user (e.g., a clinician and/or the recipient) when a change (e.g., an abnormal rise) in impedance over time is detected.
  • the corresponding reduction in electrode surface area can be deduced using the above formula to assess the severity of the wear, dissolution, or corrosion (refer to FIGs. 2C-2G).
  • a warning can be provided to the user/clinician to prompt a change of stimulation parameters in order to slow, minimize, or prevent further loss of electrode material, as described further below.
  • FIG. 4A is a flowchart of a method 400 according to an example embodiment.
  • the collection of baseline data can also be implemented for devices that have already been implanted in the recipient for a relatively long period of time .
  • the system can analyze the current data with respect to the baseline data in order to deduce any relative change in the surface area based on a relative change in the impedance.
  • the remedial action can be triggered in response to a determination that the wear/dissolution status of the electrode (i.e., the current amount of wear/dissolution that has been experienced by the electrode) has reached a certain threshold percentage of the total value of the new/virgin electrode (i.e., its original mass, volume, thickness, surface area, etc.).
  • the remedial action can be triggered in response to a determination that the wear/dissolution rate of the electrode (i.e., how fast the reduction in surface area is occurring) is higher than a certain threshold rate (e.g., the current rate will likely result in the electrode wearing out, dissolving, or corroding before the end of the recipient’s lifetime).
  • the remedial action is to identify an adjustment of a stimulation parameter or an operational setting of the medical device of which the electrode is a part.
  • adjustments include, but are not limited to: adjust (reduce/decrease) the current level applied by the electrode, adjust (reduce/decrease) the stimulation pulse rate applied by the electrode, adjust (increase) the stimulation pulse width, adjust (reduce/decrease) the degree of focusing for one or more channels when using multipolar stimulation (i.e., redistribute charge/current to spread out the stimulation to neighboring electrodes), change the stimulation mode/type (from a higher charge mode/type to a lower charge mode/type), change channels (shift sound to another channel), disable one or more channels, or otherwise adjust the makeup of certain channels (e.g., using a different combination of electrodes to provide stimulation, instead of the wom/dissolved electrode).
  • the system can use the techniques described herein to balance the benefit of slowing down the rate of wear/dissolution with resulting loss in hearing performance. Adjusting (e.g., reducing/decreasing) the operational parameter to reduce (slow down) a future rate of wear/dissolution/corrosion can also decrease hearing performance. Conversely, adjusting (e.g., increasing) the operational parameter to increase hearing performance can also increase the rate of wear/dissolution/corrosion. Various kinds of adjustments (e.g., smaller or larger amounts of adjustment, or adjusting different parameters/settings) can be used to achieve this balance.
  • the recipient or the medical device itself can dynamically switch between a “high-performance mode” and a “reduced-performance mode,” as needed over time (e.g., depending on the recipient’s environment and desired usage).
  • This switching of modes could be performed on- demand (based on manual user input), or automatically (based on detecting changes in the recipient’s environment, identifying that certain sound classes are present, etc.).
  • the high-performance mode e.g., increased current/charge level, focused multipolar mode, etc.
  • the reduced-performance mode e.g., reduced current/charge level, monopolar or bipolar mode, etc.
  • the goal is to maintain sufficient longevity of the electrode (e.g., for the lifetime of the recipient) while still ensuring an ideal level of hearing performance as a result of the adjustments of the operational parameter(s) overtime.
  • the remedial action can be to instruct the recipient to use medical device in a different manner to reduce the rate of wear/dissolution/corrosion, and thereby extend longevity of the electrodes.
  • Several illustrative examples of such instructions include, but are not limited to: limit use of the medical device (e.g., only when engaging in conversations, listening to music, etc.), reduce the proportion of time and/or a number of listening environments in which focused multipolar stimulation is delivered by the implant, reduce the amount of time that the implant is used per day, per week, etc., reduce the volume to a lower level (to the extent possible while maintaining a sufficient level of hearing performance), use monopolar and/or bipolar stimulation modes more often or whenever possible (e.g., rather than focused multipolar), use a stimulation strategy of lower complexity and/or less focus by default and only a stimulation strategy of higher complexity and/or greater focus only for certain situations, as needed.
  • iterative techniques can be utilized to determine whether and how to adjust the operation of the medical device (e.g., cochlear implant, etc.) to obtain utility with respect to reducing the rate of wear, dissolution, or corrosion or otherwise extending the longevity of the electrode (e.g., so as to long at least as along as the lifetime of the recipient, or at least as long as possible while maintaining acceptable hearing performance).
  • the medical device e.g., cochlear implant, etc.
  • FIGs. 5B, 5C, and 5D show various examples merely to illustrate how the curve 507 shown in the graph of FIG. 5A would change if one of the variables (e.g., M or N) is changed.
  • the variable M is increased (e.g., to 10 as shown in FIG. 5B)
  • the resulting curve 517 in FIG. 5B will have a substantially similar shape and slope as the curve 507 in FIG. 5A, such that changing M can act as a multiplier that magnifies the result (but does not substantially alter the result).
  • the variable M could be set to 1 (or in theory, M could simply be omitted from the equation entirely) without significantly altering the outcome of the analysis.
  • variable N is changed (e.g., to -0.1 as shown in FIG. 5C, or to -3 as shown in FIG. 5D)
  • the resulting curve 527 in FIG. 5C and the resulting curve 537 in FIG. 5D will each have a substantially different shape and slope from the curve 507 of FIG. 5 A, such that changing N therefore alters the relationship between the change in impedance (Y) compared to the change in surface area (X) in the simplified equation.
  • the variable N is most likely related to the shape of the electrode (e.g., the edge effect, surface roughness, three-dimensional shape, etc.), and further development can be performed to more accurately know how the initial geometry of the electrode would drive surface area changes.
  • the techniques described herein are much more sensitive to changes in the exponent (N) than to changes in the multiplier (M).
  • FIG. 5E is a graph resulting from a data analysis that shows a trend (average change in impedance) over time in a cochlear implant.
  • the x-axis represents a number of years since switching on the implantable medical device, and the y-axis represents an average change in impedance (as a percentage per day).
  • a data analysis of existing cochlear implant electrodes indicates that impedance measurements between 3-17 years after activation (switching on the implantable medical device) are relatively stable with low variability (i.e., the average change in impedance (%/day) shown in FIG.
  • 5E remains substantially steady in a range between approximately -0.01% and approximately +0.01% from year 3 to year 17), which supports the feasibility of detecting electrode corrosion and predicting the onset of electrode corrosion using the system and techniques described herein.
  • the impedance measurements between 17-21 years after implant activation are somewhat less stable with more variability (i.e., the average change in impedance (%/day) shown in FIG. 5E is approximately -0.02% at year 19 and -0.04% at year 21).
  • the method may further include performing impedance spectroscopy of the at least one implantable electrode over the period of time, and using the impedance spectroscopy of the at least one implantable electrode and the impedance of the at least one implantable electrode over the period of time to detect the non-linear increase in the impedance of the at least one implantable electrode indicative of the change in the surface area of the at least one implantable electrode.
  • initiating one or more remedial actions at operation 740 includes adjusting one or more parameters of the stimulation pulses delivered via the at least one implantable electrode to reduce a likelihood of additional surface area change of the at least one implantable electrode.
  • the adjustment may include one or more of: reducing a rate at which the stimulation pulses are delivered via the at least one implantable electrode, reducing a stimulation level at which the stimulation pulses are delivered via the at least one implantable electrode, or increasing a pulse width at which the stimulation pulses are delivered via the at least one implantable electrode.
  • the example embodiments described above provide systems, devices, and/or methods that can enable the detection of wear, dissolution (passive or active), or corrosion, and provide an estimation of the status of one or more implanted electrodes with respect to wear, dissolution, or corrosion.
  • the techniques can also provide an estimation of the remaining lifetime of the one or more implanted electrodes based on the status of the respective electrodes.
  • Some example embodiments can help to prevent, avoid, inhibit, or limit the occurrence of deleterious wear events of a given electrode (i.e., that would otherwise result in the electrode no longer being able to stimulate at a utilitarian level) over the lifetime of the electrode, or otherwise extend the lifetime of the electrode beyond that which would be the case in the absence of the techniques described herein.
  • the techniques described herein provide for the detection of a deleterious electrode wear event that is currently in progress or that will likely occur in the future, so that certain remedial actions can be taken to address the current or future occurrence of wear, dissolution, or corrosion of the electrode.
  • the implantable portion of the medical device is configured to, while implanted in a human, obtain data indicative of wear, dissolution (passive or active), or corrosion of at least one of the plurality of electrodes of the stimulating assembly.
  • the implantable portion can correspond to a receiver-stimulator of a cochlear implant, and can have a logic circuit (e.g., control circuitry 170 of FIG. ID) that can be configured to control the application of electrical signals to the various pertinent electrode(s) so as to provide voltage differentials in a controlled manner between electrodes.
  • the logic circuit could be in the external component of the cochlear implant (e.g., sound processing unit).
  • the implantable component can be configured to provide a telemetry signal to the external device that is indicative of voltage readings or current readings (and/or impedance readings that are based on the voltage/current readings).
  • the telemetry signal can include raw data (for analysis by the external device), or can include the results of an analysis executed by the implantable component itself.
  • the existing electrodes of a cochlear implant electrode array can be utilized in combination with the electrodes of the implantable component (and/or the external component, such as a sound processor, or other external device) to obtain electrical measurements relating to the electrodes.
  • the signals applied to the electrodes can be modified to provide the stimulus that results in enablement of a phenomenon that can be read by read electrodes that corresponds to the obtained data.
  • the implantable portion (receiver-stimulator) is configured to transcutaneously communicate the obtained data (raw electrical measurement data) and/or data based thereon (e.g., impedance measurement data, or results of analyzing the electrical measurement data) to an external device located outside the human via an inductance coil of the implantable portion.
  • the transceiver of the implantable portion is configured to provide a telemetric signal from the implantable portion, through the skin of the human, to the external portion (e.g., sound processor) or an external device (e.g., a computer or smartphone).
  • a remedial action e.g., shifting channels, or implementing a constructive and/or destructive interference regime
  • the electrode and its corresponding stimulation parameter are no longer under a safety limit (e.g., Shannon limit).
  • the stimulation parameter can be changed to comply with the safety limit, or else the electrode can be disabled altogether at the end of its life.
  • the various measurements and other data collection techniques described herein can be made on an individual electrode, a selected subset of electrodes, a representative test electrode, or all of the electrodes of an array at regular intervals (e.g., daily, weekly, monthly, yearly, etc.) and/or at irregular intervals (e.g., on-demand, responsive to a detection event, responsive to an adjustment to a stimulation parameter or operational setting of the implant, etc.), and can be logged (i.e., collected and stored) by one or more components of the system, such as the implantable portion, the external portion (e.g., sound processor), or an external device (e.g., computer or smartphone) or other remote server in communication with the implantable portion or the external portion.
  • regular intervals e.g., daily, weekly, monthly, yearly, etc.
  • irregular intervals e.g., on-demand, responsive to a detection event, responsive to an adjustment to a stimulation parameter or operational setting of the implant, etc.
  • irregular intervals e.g.,
  • any stimulation parameter or other operational setting that can be logged can be further utilized to derive (calculate, estimate) or otherwise deduce the current electrode status (e.g., an amount of wear, dissolution, or corrosion, and/or a current or future rate of wear, dissolution, or corrosion) according to the techniques described herein.
  • the current electrode status e.g., an amount of wear, dissolution, or corrosion, and/or a current or future rate of wear, dissolution, or corrosion
  • the algorithm may also take into account the position of the electrode in the array, the position of the electrode array within the human recipient, and/or the status of neighboring electrodes, which are spatial variables that can potentially impact the various measurements described herein. By taking into account these spatial variables, the accuracy of the data analysis can be further improved, so as to further increase the accuracy of the analysis relating to the electrode status and/or the rate of wear, dissolution, or corrosion.
  • one or more latent variables can be utilized to ascertain or otherwise estimate an electrode state (e.g., a state of wear, a state of dissolution, a state of corrosion, etc.) of an electrode.
  • an electrode state e.g., a state of wear, a state of dissolution, a state of corrosion, etc.
  • certain electrical properties such as voltage, current, and/or impedance that can be measured by the implantable portion of the medical device can be impacted by properties of an electrode at different points during its lifetime.
  • These properties can be measured by passing a measurement current between two electrodes (e.g., using one out of a plurality of intra-cochlear electrodes (ICEs) of an array as a “source,” and using either an extra-cochlear electrode (ECE) or another one of the intra-cochlear electrodes of the array as a “sink”), and measuring a voltage between the same two electrodes at a time while the current is being passed.
  • a relatively distinct change in impedance (Z) can be detected by the analysis, and used to generate the electrode status that is indicative of the amount and/or the rate of wear, dissolution, or corrosion of the electrode.
  • the implantable electrode array is configured to provide an abrupt change in an electrical phenomenon (e.g., at least a certain minimum/threshold percentage difference in the values of current, voltage, and/or impedance) upon one or more electrodes reaching a certain wear status, dissolution status (passive or active), or corrosion status.
  • the electrodes can have different sizes and shapes, and hence, can have different exposed surfaces areas.
  • a given electrode can have a number of layers, and one or more of the layers can have different structural properties (e.g., different materials, different porosities, etc.) that can affect the measurement of the electrical properties (e.g., current, voltage, and/or impedance) in various ways.
  • an electrode can have an upper layer (top layer) that is exposed to the ambient environment (e.g., the cochlea region within the body of the recipient), with a surface area that is rectangular in shape, or a surface area that is circular or oblong in shape, etc., a lower layer that is not exposed, and one or more intermediate layers disposed between the upper layer and the lower layer.
  • One or more of these layers can be formed from different materials (e.g., platinum, iridium, gold, silver, etc., or alloys of two or more of such materials) and/or can have different thicknesses, such that they each have a different electrical property in relation to one another.
  • the different materials that are utilized for the lower layer (and/or any intermediate layers) of an electrode can have different cyclic voltammetry (CV) spectrum relative to the material(s) that is/are utilized for the upper layer. Cyclic voltammetry measurements can be performed periodically or irregularly using the implantable portion of the medical device. If one of the CV readings indicates a difference, such as a change in shape from a first shape representing a first material (e.g., platinum) to a second shape that is more representative of a second material (e.g., iridium), then that can serve as an indication that the electrode has worn, dissolved, or corroded to the depth where the second material was deposited.
  • a first shape representing a first material e.g., platinum
  • a second shape e.g., iridium
  • Such techniques involving the use of materials with different electrical properties to identify wear, dissolution, or corrosion can be used in conjunction with the above-described techniques that use a distinct change in impedance over time to identify a change in surface area in order to provide more accurate and reliable estimations of the electrode status.
  • Values for a new (pristine, virgin) electrode at the time of implantation can be known. For example, values for initial thicknesses, initial exposed surface areas, and initial impedances can be stored as baseline/reference values for the electrodes. As the electrodes are utilized over an extended period of time (e.g., several years), and the longer that the electrode array is exposed to the ambient environment within the human body (e.g., the perilymph within the cochlea), the upper layer of the electrode that is exposed to the ambient environment will eventually wear out, dissolve, and/or corrode over time.
  • an indication or representation of the thickness or the exposed surface area can be derived (calculated, estimated) from the known baseline/reference values and through measurements of the current impedances, according to the techniques described herein.
  • a minimal degree of wear, dissolution, or corrosion may not result in a substantial change in the electrical properties of the electrode.
  • the electrode continues to wear, dissolve, or corrode over time (due to use and/or exposure to the ambient environment), there will eventually come a point where the thickness and/or the surface area decreases to such an extent that the electrical properties and/or the performance of the implantable portion of the medical device will change in a noticeable and measurable manner.
  • the amount of wear, dissolution, or corrosion can be distributed evenly or unevenly across the exposed upper surface of the electrode (e.g., one side can wear out faster than another side, or the edges can wear out faster than the middle region), such that different layers can be partially exposed and partially covered at different times during the usable life of the electrode.
  • the amount (e.g., percentage) of the surface area of a particular layer that is exposed to the ambient environment can be variable and may be different for different recipients, for different stimulation parameters, and/or for different operational settings of the implant.
  • the electrode can have different layers with different “structure” (as distinguished from different materials) or varying degrees of “porosity” at different depths, and the different structure or varying porosity enables the in vivo analysis.
  • the electrode wears down, erodes, dissolves, corrodes, etc., the lower layers of the electrode become exposed over time.
  • the electrochemical behavior of the surface changes. For example, a lower layer with a greater porosity exposes a different surface area of the electrode to the ambient environment in relation the upper layer (which has a relatively lesser porosity in this example).
  • a lower layer with a lesser porosity exposes a different surface area of the electrode to the ambient environment in relation to the upper layer (which has a relatively greater porosity in this example).
  • at least a distinct change in the surface area i.e., relative to the upper layer that has worn down to expose the lower layer
  • the distinct change in surface area can be utilized as an indicator of the electrode status.
  • Electrochemical measurements can be used to detect the exposure of the change (e.g., decrease or increase) in surface area, and thus determine that the region is exposed (and hence, that the overlying layer has worn away, dissolved, etc.).
  • the stimulation history of that electrode e.g., from device records/logs
  • the electrode status can be used in combination with the electrode status to predict the expected remaining lifetime of the electrode (and/or other electrodes of the array).
  • the vestibular stimulator 1012, the external device 1004, and/or another external device can be configured to implement the techniques presented herein. That is, the vestibular stimulator 1012, possibly in combination with the external device 1004 and/or another external device, can include an evoked biological response analysis system, as described elsewhere herein.
  • sensory inputs are absorbed by a microelectronic array of the sensor-stimulator 1190 that is hybridized to a glass piece 1192 including, for example, an embedded array of microwires.
  • the glass can have a curved surface that conforms to the inner radius of the retina.
  • the sensor-stimulator 1190 can include a microelectronic imaging device that can be made of thin silicon containing integrated circuitry that convert the incident photons to an electronic charge.
  • steps of a process are disclosed, those steps are described for purposes of illustrating the present methods and systems and are not intended to limit the disclosure to a particular sequence of steps. For example, the steps can be performed in differing order, two or more steps can be performed concurrently, additional steps can be performed, and disclosed steps can be excluded without departing from the present disclosure. Further, the disclosed processes can be repeated.

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Abstract

L'invention concerne des techniques permettant de surveiller un état physique (par exemple, une surface) d'une ou de plusieurs électrodes implantables d'un dispositif médical implantable/composant implantable et d'utiliser l'état physique pour ajuster le fonctionnement du composant implantable. Plus spécifiquement, un exemple de dispositif médical implantable comprend une ou plusieurs électrodes qui sont utilisées pour émettre une stimulation électrique (signaux de courant) envers un destinataire.
PCT/IB2025/050047 2024-01-09 2025-01-02 Surveillance d'électrode Pending WO2025149854A1 (fr)

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US20130253612A1 (en) * 2011-07-14 2013-09-26 Cyberonics, Inc. Circuit, system and method for far-field radiative powering of an implantable medical device
US20160310738A1 (en) * 2011-05-24 2016-10-27 Herbert Mauch Integrity evaluation system in an implantable hearing prosthesis
US20200269058A1 (en) * 2019-02-21 2020-08-27 Envoy Medical Corporation Implantable cochlear system with integrated components and lead characterization
US20220296122A1 (en) * 2019-07-11 2022-09-22 Advanced Bionics Ag Systems for determining when an electrode lead reaches a cochlear basal turn during a lead insertion procedure

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120221065A1 (en) * 2005-10-28 2012-08-30 Cyberonics, Inc. Lead condition assessment for an implantable medical device
US20160310738A1 (en) * 2011-05-24 2016-10-27 Herbert Mauch Integrity evaluation system in an implantable hearing prosthesis
US20130253612A1 (en) * 2011-07-14 2013-09-26 Cyberonics, Inc. Circuit, system and method for far-field radiative powering of an implantable medical device
US20200269058A1 (en) * 2019-02-21 2020-08-27 Envoy Medical Corporation Implantable cochlear system with integrated components and lead characterization
US20220296122A1 (en) * 2019-07-11 2022-09-22 Advanced Bionics Ag Systems for determining when an electrode lead reaches a cochlear basal turn during a lead insertion procedure

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