WO2025125987A1 - Interoperative measurements - Google Patents
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- WO2025125987A1 WO2025125987A1 PCT/IB2024/062215 IB2024062215W WO2025125987A1 WO 2025125987 A1 WO2025125987 A1 WO 2025125987A1 IB 2024062215 W IB2024062215 W IB 2024062215W WO 2025125987 A1 WO2025125987 A1 WO 2025125987A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
- A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
- A61B5/063—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using impedance measurements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0526—Head electrodes
- A61N1/0541—Cochlear electrodes
-
- 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
- A61N1/37211—Means for communicating with stimulators
- A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0031—Implanted circuitry
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/291—Bioelectric electrodes therefor specially adapted for particular uses for electroencephalography [EEG]
- A61B5/293—Invasive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/294—Bioelectric electrodes therefor specially adapted for particular uses for nerve conduction study [NCS]
-
- 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
- A61N1/378—Electrical supply
- A61N1/3787—Electrical supply from an external energy source
Definitions
- the present invention relates generally to using a far-field wireless communication link to transfer intraoperative measurement data to an external device.
- Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades.
- Medical devices can include internal or implantable components/devices, 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.
- 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.
- FIG. 5 is a flow chart illustrating a method for transmitting data representative of one or more measurements performed during insertion of a stimulating assembly of an implantable medical device to an external device via a far field communication link, according to techniques described herein;
- an external monitoring device external device
- the external device can be coupled to the implantable medical device directly using a 2.4 GHz or other far-field wireless communication protocol.
- Directly coupling the external device to the implantable medical device removes the need for an intermediary device during the surgical procedure.
- an external power supply can power the implantable medical device using a power link separate from the communication link.
- 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, that is configured to send data and power to the implantable component 112.
- OTE off-the-ear
- the OTE sound processing unit 106 is merely illustrative of the external devices that could operate with implantable component 112.
- the external component 104 can comprise a behind-the-ear (BTE) sound processing unit configured to be attached to, and worn adjacent to, the recipient’s ear.
- BTE sound processing unit comprises a housing that is shaped to be worn on the outer ear of the user and is connected to the separate external coil assembly via a cable, where the external coil assembly is configured to be magnetically and inductively coupled to the implantable coil 114.
- alternative external components could be located in the user’s ear canal, worn on the body, etc.
- the cochlear implant system 102 includes the sound processing unit 106 and the cochlear implant 112, as described below, the cochlear implant 112 can operate independently from the sound processing unit 106, for at least a period, to stimulate the user.
- the cochlear implant 112 can operate in a first general mode, sometimes referred to as an “external hearing mode,” in which the sound processing unit 106 captures sound signals which are then used as the basis for delivering stimulation signals to the user.
- the cochlear implant 112 can also operate in a second general mode, sometimes referred as an “invisible hearing” mode, in which the sound processing unit 106 is unable to provide sound signals to the cochlear implant 112 (e.g., the sound processing unit 106 is not present, the sound processing unit 106 is powered-off, the sound processing unit 106 is malfunctioning, etc.).
- the cochlear implant 112 captures sound signals itself via implantable sound sensors and then uses those sound signals as the basis for delivering stimulation signals to the user. Further details regarding operation of the cochlear implant 112 in the external hearing mode are provided below, followed by details regarding operation of the cochlear implant 112 in the invisible hearing mode. It is to be appreciated that reference to the external hearing mode and the invisible hearing mode is merely illustrative and that the cochlear implant 112 could also operate in alternative modes.
- the cochlear implant system 102 is shown with an external device 110, configured to implement aspects of the techniques presented.
- the external device 110 which is shown in greater detail in FIG. IE, is a computing device, such as a personal computer (e.g., laptop, desktop, tablet), a mobile phone (e.g., smartphone), remote control unit, etc.
- the external device 110 and the cochlear implant system 102 e.g., sound processing unit 106 or the cochlear implant 112 wirelessly communicate via a bi-directional communication link 126.
- the bi-directional communication link 126 can comprise, for example, a short-range communication, such as Bluetooth link, Bluetooth Low Energy (BLE) link, a proprietary link, etc.
- BLE Bluetooth Low Energy
- the sound processing unit 106 of the external component 104 also comprises one or more input devices configured to capture and/or receive input signals (e.g., sound or data signals) at the sound processing unit 106.
- input signals e.g., sound or data signals
- the one or more input devices include, for example, one or more sound input devices 118 (e.g., one or more external microphones, audio input ports, telecoils, etc.), one or more auxiliary input devices 128 (e.g., audio ports, such as a Direct Audio Input (DAI), data ports, such as a Universal Serial Bus (USB) port, cable port, etc.), and a short-range wireless transmitter/receiver (wireless transceiver) 120 (e.g., for communication with the external device 110), each located in, on or near the sound processing unit 106.
- one or more input devices can include additional types of input devices and/or less input devices (e.g., the short- range wireless transceiver 120 and/or one or more auxiliary input devices 128 could be omitted).
- the sound processing unit 106 also comprises the external coil 108, a charging coil, a closely-coupled radio frequency transmitter/receiver (RF transceiver) 122, at least one rechargeable battery 132, and an external sound processing module 124.
- the external sound processing module 124 can be configured to perform a number of operations which are represented in FIG. ID by a sound processor 133.
- the sound processor 133 can be formed by one or more processors (e.g., one or more Digital Signal Processors (DSPs), one or more uC cores, etc.), firmware, software, etc. arranged to perform operations described herein.
- DSPs Digital Signal Processors
- the sound processor 133 can be implemented as firmware elements, partially or fully implemented with digital logic gates in one or more application-specific integrated circuits (ASICs), partially or fully in software, etc.
- FIG. ID illustrates the sound processor 133 as being implemented/performed at the external sound processing module 124, it is to be appreciated that these elements (e.g., functional operations) could also or alternatively be implemented/performed as part of the implantable sound processing module 158, as part of the external device 110, etc.
- the implantable component 112 comprises an implant body (main module) 134, a lead region 136, and the intra-cochlear stimulating assembly 116, all configured to be implanted under the skin (tissue) 115 of the user.
- the implant body 134 generally comprises a hermetically-sealed housing 138 that includes, in certain examples, at least one power source 125 (e.g., one or more batteries, one or more capacitors, etc.) 125, in which RF interface circuitry 140 and a stimulator unit 142 are disposed.
- the implant body 134 also includes the intemal/implantable coil 114 that is generally external to the housing 138, but which is connected to the RF interface circuitry 140 via a hermetic feedthrough (not shown in FIG. ID).
- 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).
- Lead region 136 includes a plurality of conductors (wires) that electrically couple the electrodes 144 to the stimulator unit 142.
- the implantable component 112 also includes an electrode outside of the cochlea, sometimes referred to as the extra-cochlear electrode (ECE) 139.
- ECE extra-cochlear electrode
- 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, can 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.
- sound processing unit 106 includes the external sound processing module 124.
- the external sound processing module 124 is configured to process the received input audio signals (received at one or more of the input devices, such as sound input devices 118 and/or auxiliary input devices 128), and convert the received input audio signals into output control signals for use in stimulating a first ear of a recipient or user (i.e., the external sound processing module 124 is configured to perform sound processing on input signals received at the sound processing unit 106).
- the one or more processors e.g., processing element(s) implementing firmware, software, etc.
- the external sound processing module 124 are configured to execute sound processing logic in memory to convert the received input audio signals into output control signals (stimulation signals) that represent electrical stimulation for delivery to the recipient.
- FIG. ID illustrates an embodiment in which the external sound processing module 124 in the sound processing unit 106 generates the output control signals.
- the sound processing unit 106 can send less processed information (e.g., audio data) to the implantable component 112 and the sound processing operations (e.g., conversion of input sounds to output control signals 156) can be performed by a processor within the implantable component 112.
- 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.
- 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. Similar to the external sound processing module 124, the implantable sound processing module 158 can comprise, for example, one or more processors and a memory device (memory) that includes sound processing logic.
- the vestibular stimulator 712 comprises an implant body (main module) 734, a lead region 736, and a stimulating assembly 716, all configured to be implanted underthe skin/tissue (tissue) 715 of the recipient.
- the implant body 734 generally comprises a hermetically-sealed housing 738 in which RF interface circuitry, one or more rechargeable batteries, one or more processors, and a stimulator unit are disposed.
- the implant body 134 also includes an intemal/implantable coil 714 that is generally external to the housing 738, but which is connected to the transceiver via a hermetic feedthrough (not shown).
- the stimulating assembly 716 comprises a plurality of electrodes 744(l)-(3) disposed in a carrier member (e.g., a flexible silicone body).
- the stimulating assembly 716 comprises three (3) stimulation electrodes, referred to as stimulation electrodes 744(1), 744(2), and 744(3).
- the stimulation electrodes 744(1), 744(2), and 744(3) function as an electrical interface for delivery of electrical stimulation signals to the recipient’s vestibular system.
- the vestibular stimulator 712, the external device 704, and/or another external device can be configured to implement the techniques presented herein. That is, the vestibular stimulator 712, possibly in combination with the external device 704 and/or another external device, can include an evoked biological response analysis system, as described elsewhere herein.
- systems and non-transitory computer readable storage media are provided.
- the systems are configured with hardware configured to execute operations analogous to the methods of the present disclosure.
- the one or more non-transitory computer readable storage media comprise instructions that, when executed by one or more processors, cause the one or more processors to execute operations analogous to the methods of the present disclosure.
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Abstract
Presented herein are techniques for transmitting information between an implantable medical device and an external device over a far field wireless link during a surgical procedure. Methods include performing one or more intra-operative measurements and transmitting, by the implantable medical device, data representative of the one or more measurements (intra-operative measurement data) to the external device via a far field communication link.
Description
INTEROPERATIVE MEASUREMENTS
BACKGROUND
Field of the Invention
[oooi] The present invention relates generally to using a far-field wireless communication link to transfer intraoperative measurement data to an external device.
Related Art
[0002] Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices can include internal or implantable components/devices, 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.
[0003] The types of medical devices and the ranges of functions performed thereby have increased over the years. For example, many medical devices, sometimes referred to as “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.
SUMMARY
[0004] In one aspect, a surgical method is provided. The first surgical method comprises: performing one or more measurements with one or more electrodes of an implantable medical device of a recipient while the one or more electrodes of the implantable medical device are being inserted during a surgical procedure; and while the stimulating assembly is being inserted, transmitting, by the implantable medical device, data representative of the one or more measurements to an external device via a far field communication link.
[0005] In another aspect, another surgical method is provided. The second surgical method comprises: capturing one or more neural responses from an inner ear of a recipient of a stimulating assembly of a cochlear implant during insertion of the stimulating assembly into the inner ear; and sending the one or more neural responses directly to an external device via a far-field wireless link.
[0006] In another aspect, a system is provided. The system comprises: an external device; an implantable component being inserted during a surgical procedure, the implantable component being configured to: perform one or more measurements while the implantable component is being inserted during the surgical procedure, and transmit data representative of the one or more measurements to the external device via a far-field wireless link while the implantable component is being inserted during the medical procedure; and the far-field wireless link.
[0007] In another aspect, one or more non-transitory computer readable storage media comprising instructions are provided that, when executed by a processor of an implantable medical device of a recipient, cause the processor to: perform one or more measurements with one or more electrodes of the implantable medical device while the one or more electrodes are being inserted into the recipient during a surgical procedure; and while the one or more electrodes are being inserted, transmit data representative of the one or more measurements to an external device via a far field communication link.
[0008] In another aspect, an implantable component is provided. The implantable component comprises: a stimulating assembly comprising one or more electrodes; measurement circuitry configured to use the one or more electrodes to perform one or more measurements while the implantable component is being implanted in a recipient; and a far-field wireless transceiver configured to transmit data representative of the one or more measurements to an external device via a far-field wireless link while the implantable component is being implanted in the recipient.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Embodiments of the present invention are described herein in conjunction with the accompanying drawings, in which:
[0010] FIG. 1A is a schematic diagram illustrating a cochlear implant system with which aspects of the techniques presented herein can be implemented;
[ooii] FIG. IB is a side view of a recipient wearing a sound processing unit of the cochlear implant system of FIG. 1A;
[0012] FIG. 1C is a schematic view of components of the cochlear implant system of FIG. 1 A;
[0013] FIG. ID is a block diagram of the cochlear implant system of FIG. 1A;
[0014] FIG. IE is a schematic diagram illustrating a computing device with which aspects of the techniques presented herein can be implemented;
[0015] FIG. 2A is a block diagram illustrating an implantable medical device with an implantable power supply coupled to an external device via a far-field communication link, with which aspects of the techniques presented herein can be implemented;
[0016] FIG. 2B is a block diagram illustrating an implantable medical device coupled to an external device via a far-field communication link and coupled to an external power supply, with which aspects of the techniques presented herein can be implemented;
[0017] FIG. 3 is a diagram illustrating a system in which measurements can be captured using a far-field communication link, according to techniques described herein;
[0018] FIG. 4A is a diagram illustrating triggering stimulation based on a data packet, according to techniques described herein;
[0019] FIG. 4B is a diagram illustrating triggering stimulation based on a sync packet, according to techniques described herein;
[0020] FIG. 5 is a flow chart illustrating a method for transmitting data representative of one or more measurements performed during insertion of a stimulating assembly of an implantable medical device to an external device via a far field communication link, according to techniques described herein;
[0021] FIG. 6 is a flow chart illustrating a method for sending one or more neural responses to an external device via a far-field wireless link during inserting of a stimulating assembly into an inner ear of a recipient, according to techniques described herein;
[0022] FIG. 7 is a schematic diagram illustrating a vestibular stimulator system with which aspects of the techniques presented herein can be implemented; and
[0023] FIG. 8 is a schematic diagram illustrating a retinal prosthesis system with which aspects of the techniques presented herein can be implemented.
DETAILED DESCRIPTION
[0024] In conventional surgical procedures for implantation of an implantable medical device in a recipient, intra-operative measurement data is obtained using a “closely-coupled” or “near- field” communication link. More specifically, in these conventional arrangements, an intermediary device (e.g., surgical sound processor) with an external radio-frequency (RF) coil is positioned so that the external RF is closely coupled to an implantable RF coil of the implantable medical device. The intermediary device uses the closely-coupled link to obtain the intra-operative measurement data from the implantable medical device, then the intermediary device forwards the intra-operative measurement data to an external monitoring device (external device). In other words, the external device is not coupled with the implantable medical device and, instead, the intermediary device acts as a gateway/connection-agent between the implantable medical device and an external device (e.g., tablet computer, fitting system, etc.) on which the surgeon can observe the results.
[0025] In these conventional arrangements, the RF coil of the intermediary device must remain closely-coupled to (i.e., relatively close to and aligned precisely with) the RF coil of implantable medical device during the surgical procedure. However, maintaining this closecoupling is difficult since the intermediary device is separated from the body of the recipient by a relatively large distance due to, for example, the recipient’s skin thickness, multiple layers of surgical drapes, etc.
[0026] More specifically, during implantation surgery (e.g., a cochlear implant surgery), a sterile field is established around the surgical site by placing sterile surgical drapes around the incision. To maintain sterility, the intermediary device (e.g., processing unit, radio frequency (RF) coil, and coil cable) used to obtain the intra-operative measurement data and the ear tube are not in the sterile field. In certain examples, a relatively long coil cable (e.g., 1 or 2 meters long) is often used to allow the processing unit to be located on the chest of the recipient of the cochlear implant so the ear tube can reach the ear canal without crossing the sterile field. Using a long coil cable results in greater electromagnetic emissions than shorter cable lengths, reducing efficiency of power and data transfer and mimicking a skin flap thickness (SFT)
increase across the sound processor coil and the implant coil RF interface. Additionally, the area surrounding the incision can swell during surgery and the surgical drapes surrounding the sterile field add distance between the sound processor coil and the implant coil, further increasing the effective skin flap thickness. Therefore, power and data transfer to the implant while performing surgical measurements can be intermittent. In addition, backlink telemetric pulses can interfere with measurements being taken.
[0027] Presented herein are techniques for directly coupling an external monitoring device (external device) to an implantable medical device using a far-field wireless communication protocol/far-field communication link during a surgical procedure. According to techniques described herein, the external device can be coupled to the implantable medical device directly using a 2.4 GHz or other far-field wireless communication protocol. Directly coupling the external device to the implantable medical device removes the need for an intermediary device during the surgical procedure. For implantable medical devices that do not contain a battery, an external power supply can power the implantable medical device using a power link separate from the communication link.
[0028] The techniques described herein provide for managing fewer devices during the surgical procedure while still allowing for the same depth of insight from intra-operative measurements. In addition, a far-field (e.g., 2.4 GHz) communication link can provide a higher bandwidth connection than a near-field communication link, which allows for a fast refresh rate and response time of data. The use of the far-field communications link eliminates or minimizes intermittent data transfer due to a long coil cable or distance between the sound processor coil and implant coil and minimizes interference caused by backlink telemetric pulses. In addition, a more robust surgical tool can be created using techniques described herein without requiring additional hardware (e.g., an external device, a sound processor, a custom surgical coil, etc.) to be developed and maintained.
[0029] Techniques described herein additionally provide for synchronizing timing of signals for performing measurements over the far-field communications link. For example, techniques described herein provide for a protocol for the far-field/independent link that provides accurate timing between when data is transmitted to an implantable medical device and when the stimulation pulses are generated or measurements are taken related to that data.
[0030] There are a number of different types of devices in/with which embodiments of the present invention can be implemented. Merely for ease of description, 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 can also be partially or fully implemented by any of a number of different types of devices, including consumer electronic device (e.g., mobile phones), wearable devices (e.g., smartwatches), hearing devices, implantable medical devices, wearable devices, etc. consumer electronic devices, wearable devices (e.g., smart watches, etc.), etc. As used herein, the term “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. As such, 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). In other examples, 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.
[0031] 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. In the examples of FIGs. 1A-1D, 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, while 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, while FIG. ID illustrates further details of the cochlear implant system 102. For ease of description, FIGs. 1A-1D will generally be described together.
[0032] In the examples of FIGs. 1A-1D, 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. In one example, the sound processing unit 106 is an off-the-ear (OTE) sound processing unit, sometimes referred to herein as an OTE component, that is configured to send data and power to the implantable component 112. In general, 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.
[0033] It is to be appreciated that the OTE sound processing unit 106 is merely illustrative of the external devices that could operate with implantable component 112. For example, in alternative examples, the external component 104 can comprise a behind-the-ear (BTE) sound processing unit configured to be attached to, and worn adjacent to, the recipient’s ear. In general, a BTE sound processing unit comprises a housing that is shaped to be worn on the outer ear of the user and is connected to the separate external coil assembly via a cable, where the external coil assembly is configured to be magnetically and inductively coupled to the implantable coil 114. It is also to be appreciated that alternative external components could be located in the user’s ear canal, worn on the body, etc. In other examples, the external component 104 can comprise a charger, such as an OTE charger, BTE charger, body-worn charger with coil, etc. The charger can provide power to a battery powered implantable device if the battery level at the implantable device is too low. For example, a charger can provide power to the battery of an implantable device if the battery at the implantable device becomes too low during a surgical procedure.
[0034] Although the cochlear implant system 102 includes the sound processing unit 106 and the cochlear implant 112, as described below, the cochlear implant 112 can operate independently from the sound processing unit 106, for at least a period, to stimulate the user. For example, the cochlear implant 112 can operate in a first general mode, sometimes referred to as an “external hearing mode,” in which the sound processing unit 106 captures sound signals which are then used as the basis for delivering stimulation signals to the user. The cochlear implant 112 can also operate in a second general mode, sometimes referred as an “invisible hearing” mode, in which the sound processing unit 106 is unable to provide sound
signals to the cochlear implant 112 (e.g., the sound processing unit 106 is not present, the sound processing unit 106 is powered-off, the sound processing unit 106 is malfunctioning, etc.). As such, in the invisible hearing mode, the cochlear implant 112 captures sound signals itself via implantable sound sensors and then uses those sound signals as the basis for delivering stimulation signals to the user. Further details regarding operation of the cochlear implant 112 in the external hearing mode are provided below, followed by details regarding operation of the cochlear implant 112 in the invisible hearing mode. It is to be appreciated that reference to the external hearing mode and the invisible hearing mode is merely illustrative and that the cochlear implant 112 could also operate in alternative modes.
[0035] In FIGs. 1A and 1C, the cochlear implant system 102 is shown with an external device 110, configured to implement aspects of the techniques presented. The external device 110, which is shown in greater detail in FIG. IE, is a computing device, such as a personal computer (e.g., laptop, desktop, tablet), a mobile phone (e.g., smartphone), remote control unit, etc. The external device 110 and the cochlear implant system 102 (e.g., sound processing unit 106 or the cochlear implant 112) wirelessly communicate via a bi-directional communication link 126. The bi-directional communication link 126 can comprise, for example, a short-range communication, such as Bluetooth link, Bluetooth Low Energy (BLE) link, a proprietary link, etc.
[0036] Returning to the example of FIGs. 1A-1D, the sound processing unit 106 of the external component 104 also comprises one or more input devices configured to capture and/or receive input signals (e.g., sound or data signals) at the sound processing unit 106. The one or more input devices include, for example, one or more sound input devices 118 (e.g., one or more external microphones, audio input ports, telecoils, etc.), one or more auxiliary input devices 128 (e.g., audio ports, such as a Direct Audio Input (DAI), data ports, such as a Universal Serial Bus (USB) port, cable port, etc.), and a short-range wireless transmitter/receiver (wireless transceiver) 120 (e.g., for communication with the external device 110), each located in, on or near the sound processing unit 106. However, it is to be appreciated that one or more input devices can include additional types of input devices and/or less input devices (e.g., the short- range wireless transceiver 120 and/or one or more auxiliary input devices 128 could be omitted).
[0037] The sound processing unit 106 also comprises the external coil 108, a charging coil, a closely-coupled radio frequency transmitter/receiver (RF transceiver) 122, at least one rechargeable battery 132, and an external sound processing module 124. The external sound
processing module 124 can be configured to perform a number of operations which are represented in FIG. ID by a sound processor 133. The sound processor 133 can be formed by one or more processors (e.g., one or more Digital Signal Processors (DSPs), one or more uC cores, etc.), firmware, software, etc. arranged to perform operations described herein. That is, the sound processor 133 can be implemented as firmware elements, partially or fully implemented with digital logic gates in one or more application-specific integrated circuits (ASICs), partially or fully in software, etc. Although FIG. ID illustrates the sound processor 133 as being implemented/performed at the external sound processing module 124, it is to be appreciated that these elements (e.g., functional operations) could also or alternatively be implemented/performed as part of the implantable sound processing module 158, as part of the external device 110, etc.
[0038] Returning to the example of FIGs. 1A-1D, the implantable component 112 comprises an implant body (main module) 134, a lead region 136, and the intra-cochlear stimulating assembly 116, all configured to be implanted under the skin (tissue) 115 of the user. The implant body 134 generally comprises a hermetically-sealed housing 138 that includes, in certain examples, at least one power source 125 (e.g., one or more batteries, one or more capacitors, etc.) 125, in which RF interface circuitry 140 and a stimulator unit 142 are disposed. The implant body 134 also includes the intemal/implantable coil 114 that is generally external to the housing 138, but which is connected to the RF interface circuitry 140 via a hermetic feedthrough (not shown in FIG. ID).
[0039] As noted, 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). Lead region 136 includes a plurality of conductors (wires) that electrically couple the electrodes 144 to the stimulator unit 142. The implantable component 112 also includes an electrode outside of the cochlea, sometimes referred to as the extra-cochlear electrode (ECE) 139.
[0040] As noted, 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. In certain examples, the closely-coupled wireless link 148 is a radio frequency (RF) link. However, various other types of energy transfer, such as infrared (IR), electromagnetic, capacitive and inductive transfer, can 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.
[0041] As noted above, sound processing unit 106 includes the external sound processing module 124. The external sound processing module 124 is configured to process the received input audio signals (received at one or more of the input devices, such as sound input devices 118 and/or auxiliary input devices 128), and convert the received input audio signals into output control signals for use in stimulating a first ear of a recipient or user (i.e., the external sound processing module 124 is configured to perform sound processing on input signals received at the sound processing unit 106). Stated differently, the one or more processors (e.g., processing element(s) implementing firmware, software, etc.) in the external sound processing module 124 are configured to execute sound processing logic in memory to convert the received input audio signals into output control signals (stimulation signals) that represent electrical stimulation for delivery to the recipient.
[0042] As noted, FIG. ID illustrates an embodiment in which the external sound processing module 124 in the sound processing unit 106 generates the output control signals. In an alternative embodiment, the sound processing unit 106 can send less processed information (e.g., audio data) to the implantable component 112 and the sound processing operations (e.g., conversion of input sounds to output control signals 156) can be performed by a processor within the implantable component 112.
[0043] In FIG. ID, according to an example embodiment, output control signals (stimulation 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. In this way, cochlear implant system 102 electrically stimulates the user’s auditory nerve cells, bypassing absent or defective hair cells that normally transduce acoustic vibrations into neural activity, in a manner that causes the recipient to perceive one or more components of the input audio signals (the received sound signals).
[0044] As detailed above, in the external hearing mode the cochlear implant 112 receives processed sound signals from the sound processing unit 106. However, in the invisible hearing mode, the cochlear implant 112 is configured to capture and process sound signals for use in electrically stimulating the user’s auditory nerve cells. In particular, as shown in FIG. ID, 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. Similar to the external sound processing module 124, the implantable sound processing module 158 can comprise, for example, one or more processors and a memory device (memory) that includes sound processing logic. The memory device can comprise any one or more of: Non-Volatile Memory (NVM), Ferroelectric Random Access Memory (FRAM), read only memory (ROM), random access memory (RAM), magnetic disk storage media devices, optical storage media devices, flash memory devices, electrical, optical, or other physical/tangible memory storage devices. The one or more processors are, for example, microprocessors or microcontrollers that execute instructions for the sound processing logic stored in memory device.
[0045] In the invisible hearing mode, 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). Stated differently, the one or more processors (e.g., processing element(s) implementing firmware, software, etc.) in 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.
[0046] It is to be appreciated that the above description of the so-called external hearing mode and the so-called invisible hearing mode are merely illustrative and that the cochlear implant system 102 could operate differently in different embodiments. For example, in one alternative implementation of the external hearing mode, the cochlear implant 112 could use signals captured by the sound input devices 118 and the implantable sound sensors 165(1), 165(2) of sensor array 160 in generating stimulation signals for delivery to the user.
[0047] According to the techniques of the present disclosure, external sound processing module 124 can also include an inertial measurement unit (IMU) 170. The inertial measurement unit 170 is configured to measure the inertia of the user's head, that is, motion of the user's head. As such, inertial measurement unit 170 comprises one or more sensors 175 each configured to sense one or more of rectilinear or rotatory motion in the same or different axes . Examples of sensors 175 that can be used as part of inertial measurement unit 170 include accelerometers, gyroscopes, inclinometers, compasses, and the like. Such sensors can be implemented in, for example, micro electromechanical systems (MEMS) or with other technology suitable for the particular application.
[0048] As also illustrated in FIG. ID, in certain examples, a second inertial measurement unit (IMU) 180 including one or more sensors 185 is incorporated into implantable sound processing module 158 of implant body 134. Second inertial measurement unit 180 can serve as an additional or alternative inertial measurement unit to inertial measurement unit 170 of external sound processing module 124. Like sensors 175, sensors 185 can each be configured to sense one or more of rectilinear or rotatory motion in the same or different axes. Examples of sensors 185 that can be used as part of inertial measurement unit 180 include accelerometers, gyroscopes, inclinometers, compasses, and the like. Such sensors can be implemented in, for example, micro electromechanical systems (MEMS) or with other technology suitable for the particular application. For hearing devices that include an implantable sound processing module, such as implantable sound processing module 158, that includes an IMU, such as IMU 180, the techniques presented herein can be implemented without an external processor. Accordingly, a hearing device that includes an implant body 134 and lacks an external component 104 can be configured to implement the techniques presented herein.
[0049] FIG. IE is a block diagram illustrating one example arrangement for an external computing device 110 configured to perform one or more operations in accordance with certain embodiments presented herein. As shown in FIG. IE, in its most basic configuration, the external computing device 110 includes at least one processing unit 183 and a memory 184. The processing unit 183 includes one or more hardware or software processors (e.g., Central Processing Units) that can obtain and execute instructions. The processing unit 183 can communicate with and control the performance of other components of the external computing device 110. The memory 184 is one or more software or hardware-based computer-readable storage media operable to store information accessible by the processing unit 183. 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. In examples, 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. By way of example, and not limitation, 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. In certain embodiments, the memory 184 comprises logic 195 that, when executed, enables the processing unit 183 to perform aspects of the techniques presented.
[0050] In the illustrated example of FIG. IE, 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.
[0051] It is to be appreciated that the arrangement for 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. For example, 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.
[0052] It is to be appreciated that the use of an external component is merely illustrative and that the techniques presented herein can be used in cochlear implant arrangements and, indeed, other types of implantable medical devices. For example, in certain embodiments, the techniques presented herein can be implemented in a totally implantable cochlear implant system where all components of the cochlear implant system are configured to be implanted under the skin/tissue of a recipient or a mostly implantable cochlear implant system. Because all components are implantable, a totally implantable cochlear implant system operates, for at least a finite period of time, without the need of an external device. However, an external device can be used to, for example, charge an implantable power source of the totally implantable cochlear implant system, to receive signal data (obtained via the magnetic coils), etc. A totally implantable cochlear implant system and a mostly implantable cochlear implant system can include an implantable battery and implantable electronic assembly.
[0053] As noted, techniques described herein provide for directly coupling a monitoring device to an implantable medical device during a surgical procedure using a far-field wireless communication link. FIG. 2A is a block diagram illustrating an implantable medical device 202 coupled to an external device 204 via a far-field communications link 206. In the example
illustrated in FIG. 2A, implantable medical device 202 is internally powered. For example, implantable medical device 202 can be a totally implantable cochlear implant system, a mostly implantable cochlear implant system, or another device that includes an internal power source/supply. The internal power source can include, for example, an implantable battery or one or more capacitors that are periodically charged by an external power source. When a battery-powered implantable medical device is implanted into a recipient by a surgeon during a surgical procedure, the battery will be at least partially charged from storage and shipping, so power will be available to the implantable medical device.
[0054] External device 204 can be, for example, a smart device (e.g., a tablet, a smart phone, etc.) capable of receiving data (e.g., intra-operative measurements) from implantable medical device 202 and displaying data or measurements. In some embodiments, a surgeon or another person can interact with implantable medical device 202 with an application on the external device 204. Tests or measurements can be performed to determine whether the implantable medical device 202 is working correctly or has been implanted in the correct location. The results of the measurements or test can be displayed on the external device 204.
[0055] Far-field communications link 206 is a communication link that uses a far-field communication protocol. Far-field communications link 206 can be a 2.4 GHz link, a Bluetooth link, or another type of far-field communications link. Far-field communications link 206 can be used to transmit communications between external device 204 and implantable medical device 202. For example, external device 204 can send information to and receive information from implantable medical device 202 over far-field communications link 206 using a far-field communication protocol. In addition, implantable medical device 202 can send information to and receive information from external device 204 over far-field communications link 206 using a far-field communication protocol. In some embodiments, external device 204 or implantable medical device 202 can communicate with an additional device (e.g., an acoustic output device or another type of device) over far-field communications link 206 using a far-field communication protocol.
[0056] Transmitting and receiving communications via a far-field communications link 206 provides benefits over transmitting and receiving communications over another type of radio frequency link because the far-field communications link 206 is more robust to skin flap thickness, surgical draping, and misalignment during a surgical procedure. In addition, the far- field communications link 206 does not interfere with measurements being taken the way other types of communication links can interfere. In this way, using a far-field communications link
206 during surgical procedures can provide more accurate test results more quickly than using other types of communication links.
[0057] In some embodiments, when implantable medical device 202 is a hearing device, neural response measurements can be performed to measure the compound action potential in the cochlear nerve of the recipient of the implantable medical device 202 during insertion of the implantable medical device 202 in the inner ear of a recipient and the results can be displayed on external device 204. For example, a surgeon can insert a stimulating assembly of implantable medical device 202 into the inner ear of a recipient. The stimulating assembly can include one or more electrodes. While the stimulating assembly is being inserted, measurements can be performed with the one or more electrodes. While the stimulating assembly is inserted in the inner ear, the implantable medical device 202 can transmit data representative of the measurements (e.g., neural responses) to external device 204 via far-field communications link 206.
[0058] In another embodiment, as further described below with respect to FIG. 3, when implantable medical device 202 is a hearing device, transtympanic electrocochleography (ECochG) can be performed to measure cochlear potentials during the surgical procedure and the results can be displayed on external device 204. In this embodiment, external device 204 can use one or more far-field communications links 206 to initiate sound at an acoustic output device, initiate stimulation and/or measurements at implantable medical device 202, and receive telemetry information/intra-operative measurement data from implantable medical device 202. Additional or different measurements or tests can be performed depending on a type of the implantable medical device 202 and the results can be displayed on external device 204. For example, impedance measurements or interoperative objective measurements can be performed and the results can be displayed on external device 204.
[0059] External device 204 can additionally be used to determine whether suitable power is available to implantable medical device 202. For example, external device 204 can poll for the implantable medical device 202 and when a connection is established, request that the implantable medical device 202 report its System on Chip (SOC) or rail voltage to determine whether implantable medical device 202 has a suitable amount of power.
[0060] FIG. 2B is a block diagram illustrating an example in which implantable medical device 202 is not internally powered. For example, implantable medical device 202 can be powered by an external power supply, such as rechargeable battery 132. In this example, implantable
medical device 202 can be powered by power supply 208 during the surgical procedure. Power supply 208 can be an external device coupled to the RF coil of implantable medical device 202 and can supply power to implantable medical device 202 using power link 210. Power link 210 is a separate link than far-field communications link 206 that can send only power and, therefore, need not be optimized for data integrity.
[0061] FIG. 3 is a diagram illustrating an exemplary implementation in which techniques described herein can be applied to performing ECochG measurements. FIG. 3 includes implantable medical device 202, external device 204, far-field communications link 206, and acoustic output device 302.
[0062] ECochG is a measurement of the electrical potentials derived from the cochlea in response to acoustic input using one or more recording electrodes. A cochlear implant electrode array can be used to perform intracochlear ECochG measurements (e.g., during implantation of a cochlear implant). When sound waves enter the cochlea and move through the perilymph, the basilar membrane vibrates, which triggers hair cells and results in neural cell activation and firing of the auditory nerve. ECochG measures the cochlear microphonic (CM) and the auditory nerve neurophonic (ANN). The CM is the receptor potential from the hair cells that mimics the input stimulations (measuring vibrations in the basilar membrane). The ANN is an electrical signal from the auditory nerve firing.
[0063] External device 204 with a sound processor, an acoustic output device 302, and a cochlear implant electrode array of implantable medical device 202 can be used for ECochG measurements. In the example illustrated in FIG. 3, the external device 204 synchronously provides acoustic input via an ear tube from the acoustic output device 302 to the ear canal and sends signals to the implantable medical device 202 to perform intra-operative measurements (capture intra-operative measurement data) based on the acoustic input received from the acoustic output device 302. The acoustic output device 302 can include, for example, a wireless in-ear device (e.g., wireless earbud, hearing aid, etc.), synchronized speakers (e.g., wireless speaker, mobile phone speaker, wired speaker, etc.), a smart device (e.g., mobile phone, MP3 player, etc.) with wired headphones or earphones, a sound processor with an ear tube, etc. In response to the commands to perform intra-operative measurements, the implantable medical device 202 (e.g., the implant intracochlear electrode(s)) is used for recording CM and ANN potentials resulting from the acoustic input received from acoustic output device 302. The implantable medical device sends intra-operative measurement data to the external device 204 with results of the recording.
[0064] ECochG can be used during cochlear implant surgery for a number of different purposes. For example, ECochG can be used to monitor electrode insertion (e.g., to monitor the impact of electrode placement on CM, which can provide an indication of the heath of the interface and electrode positioning) and to provide post-insertion measurements (e.g., confirm the number of intracochlear electrodes, generate a frequency map, etc.).
[0065] As illustrated in FIG. 3, far-field communications link 206 can be established between external device 204 and implantable medical device 202 and between external device 204 and acoustic output device 302. At 304, external device 204 can send an acoustic signal to acoustic output device 302 via the far-field communications link 206. At 306, external device 204 can synchronously send a perform intra-operative measurement signal to implantable medical device 202 instructing implantable medical device 202 to deliver acoustic stimulation and perform the intra-operative measurement(s) based on receiving an audio input from acoustic output device 302. Implantable medical device 202 can be battery powered (as illustrated in FIG. 2A) or can be powered via an inductive RF power link from an external device (as illustrated in FIG. 2B).
[0066] In some embodiments, the acoustic output can be generated by a speaker of external device 204 instead of by acoustic output device 302. In this embodiment, external device 204 can send the perform intra-operative measurement signal to implantable medical device 202 with instructions to capture the intra-operative measurements based on receiving the audio input from the speaker. That is, the perform intra-operative measurement signal is synchronized with the acoustic output from the speaker.
[0067] As discussed further with respect to FIGs. 4A and 4B, synchronization of the acoustic input transmitted to the ear and the performance of intra-operative measurements is needed for certain tests of the implantable medical device 202. As such, the perform intra-operative measurement signal can be used to precisely time the start of the measurements of the electrical potentials derived from the cochlea in response to acoustic input using one or more recording electrodes.
[0068] Referring back to FIG. 3, sound waves from the acoustic output device 302 travel into the cochlea and some of the resultant physiological potentials are detected by the intracochlear electrode array of implantable medical device 202. ECochG measurements are performed based on the sound waves. At 308, implantable medical device 202 transmits a signal
containing the ECochG measurements to external device 204 via the far-field communications link 206.
[0069] Because the acoustic output from the acoustic output device 302 and the data acquisition (via sending perform intra-operative measurement signals and receipt of the measurement signal from the implant) are controlled by the same device (i.e., external device 204), synchronization is provided over multiple devices. In addition, sending signals via far- field communications link 206 overcomes problems communicating across a sound processor coil and the implant coil RF interface when the coil-coil distance is large. As a result, techniques described herein provide for fewer intermittencies in power and data transfer and easier synchronization of signals and intra-operative measurements.
[0070] To accurately record measurements during surgical procedures, it necessary to provide a precise timing of when audio signals are being generated and when measurements associated with the audio signals are started. In addition, for some measurements, the audio generation is synchronized with generation of stimulation pulses to get precise measurements.
[0071] In systems in which data and power are transferred over the same RF communication link, the protocols for sending the data and power provide a tight coupling in timing between the data that is sent to an implantable medical device and stimulation that is to be delivered or measurements that are to be made. By using a far-field communications link that transmits data without transmitting power, the same fixed timing relationship does not exist. FIGs. 4A and 4B are diagrams illustrating examples in which data synchronization is built into the independent/far-field communications link protocol so that the system has accurate timing between when data is sent to an implantable medical device and when stimulation pulses are generated, or measurements are taken with respect to the data. In these examples, stimulation pulses are triggered when signals or packets are received at an implantable medical device from an external device via a far-field communications link. In other examples, other actions (e.g., performing measurements) can be triggered based on receiving signals or packets from the external device over the far-field communications link. Different actions can be triggered based on a type of medical device associated with the implantable medical device.
[0072] FIG. 4A is a diagram 400 illustrating an example in which a start stimulation trigger is generated when a communication link address is detected. FIG. 4A illustrates a data packet 404 with starter bytes 402 received at an implantable hearing device on the right side of a recipient and a data packet 410 with starter bytes 408 received at an implantable hearing device
on the left side of the recipient. Although only one data packet 404 and one starter bytes 402 received on the right side and one data packet 410 and starter bytes 408 received on the left side are labeled in FIG. 4A for simplicity, multiple data packets with starter bytes are transmitted from an external device to an implantable medical device on both sides. A data packet can vary in size based on the data that is being transmitted. The first few bytes of the data packet are the starter bytes. The length of starter bytes is fixed and can include an address and protocol data. In other words, a length of the starter bytes at the beginning of the data packet is the same size for each of the data packets being received over the independent/far- field communications link even though the size each of the data packets can vary.
[0073] As illustrated in FIG. 4A, when data packet 404 with starter bytes 402 is received over the far-field communications link on the right side, stimulation 406 is triggered on the right side. In a similar manner, when data packet 410 with starter bytes 408 is received over the far- field communications link on the left side, stimulation 412 is triggered on the left side. The start stimulation trigger is generated when the communication link address in the starter bytes is detected on the air. Since the starter bytes are fixed in length, this will result in a fixed interval timing of stimulation packets. That data packets 404 and 410 contain the stimulation data and the offset from when the stimulation data needs to be applied. The offset can be calculated based on when the data or audio signal will be transmitted to the implantable medical device and when stimulation is to be triggered. Therefore, the hardware in the implantable medical device can trigger the stimulation based on the offset received in the data packet.
[0074] FIG. 4B is a diagram 420 illustrating an example in which stimulation is triggered based on a sync signal generated by the external device. FIG. 4B illustrates a data packet 404 and a sync signal 414 received over a far-field communications link to an implantable medical device on the right side of a recipient and a data packet 410 and a sync signal 416 received over the far-field communications link to an implantable medical device on the left side of the recipient. Sync signals 414 and 416 are short messages with a fixed length and an accurate timing. In other words, sync signals 414 and 416 are transmitted by the external device at a regular, fixed interval. In some embodiments, instead of the sync signals being transmitted as separate individual 2.4 GHz packets transmitted to the right and left sides, the sync signal can be implemented as a broadcast signal. As illustrated in FIG. 4B, when the sync signal 414 is received, the implantable medical device will use it to trigger the start of the stimulation 406 on the right side and when the sync signal 416 is received, the implantable medical device will
use it to trigger the stimulation 412 on the left side. The sync signals 414 and 416 contain one data word that is defined to be the timing offset to be applied before starting stimulation.
[0075] In some implementations, instead of using starter bytes 402 and 408 or sync signals 414 and 416 to trigger stimulation, starter bytes 402 and 408 or sync signals 414 and 416 can be used to trigger different type of measurements. For example, implantable medical device can receive data packets with instructions to perform measurements or another action and starter bytes 402 and 408 or sync signals 414 and 416 can trigger the start of the measurements or other action based on information received in the data packets. By synchronizing the start of measurements at an implantable medical device with data packets received from an external device, the measurements can be more accurate.
[0076] FIG. 5 is a flow chart illustrating a method 500 of transmitting data representative of measurements to an external device via a far field communication link. At 510, one or more measurements are performed with one or more electrodes (e.g., one or more electrodes of a plurality of electrodes of an implantable medical device) of a recipient while the implantable medical device (e.g., part of the implantable medical device, such as a stimulating assembly) is being inserted during a surgical procedure. For example, neural response measurements, impedance measurements, ECochG measurements, or other measurements can be performed by the implantable medical device while the implantable medical device is being inserted during a medical procedure. At 520, while the implantable medical device is being inserted, data representative of the one or more measurements are transmitted, by the implantable medical device, to an external device via a far field communication link. For example, the data can be transmitted to the external device for display or processing to determine whether part of the implantable medical device (e.g., a stimulating assembly) is being inserted at the right position and is working correctly. Transmitting the data via a far-field communications link provides quicker and more accurate measurement results to a surgeon performing the medical procedure while eliminating the need for additional surgical devices (e.g., long coils, additional external devices or monitors, etc.) that can complicate the surgical procedure.
[0077] FIG. 6 is a flow chart illustrating a method 600 of sending one or more neural responses directly to an external device via a far-field wireless link. At 610, one or more neural responses are captured from an inner ear of a recipient of a stimulating assembly of a cochlear implant during insertion of the stimulating assembly into the inner ear. At 620, one or more neural responses are sent directly to an external device via a far-field wireless link.
[0078] As previously described, the technology disclosed herein can be applied in any of a variety of circumstances and with a variety of different devices. Example devices that can benefit from technology disclosed herein are described in more detail in FIGS. 7 and 8. The techniques of the present disclosure can be applied to other devices, such as neurostimulators, cardiac pacemakers, cardiac defibrillators, sleep apnea management stimulators, seizure therapy stimulators, tinnitus management stimulators, and vestibular stimulation devices, as well as other medical devices that deliver stimulation to tissue. Further, technology described herein can also be applied to consumer devices. These different systems and devices can benefit from the technology described herein.
[0079] FIG. 7 illustrates an example vestibular stimulator system 702, with which embodiments presented herein can be implemented. As shown, the vestibular stimulator system 702 comprises an implantable component (vestibular stimulator) 712 and an external device/component 704 (e.g., external processing device, battery charger, remote control, etc.). The external device 704 comprises a transceiver unit 760. As such, the external device 704 is configured to transfer data (and potentially power) to the vestibular stimulator 712,
[0080] The vestibular stimulator 712 comprises an implant body (main module) 734, a lead region 736, and a stimulating assembly 716, all configured to be implanted underthe skin/tissue (tissue) 715 of the recipient. The implant body 734 generally comprises a hermetically-sealed housing 738 in which RF interface circuitry, one or more rechargeable batteries, one or more processors, and a stimulator unit are disposed. The implant body 134 also includes an intemal/implantable coil 714 that is generally external to the housing 738, but which is connected to the transceiver via a hermetic feedthrough (not shown).
[0081] The stimulating assembly 716 comprises a plurality of electrodes 744(l)-(3) disposed in a carrier member (e.g., a flexible silicone body). In this specific example, the stimulating assembly 716 comprises three (3) stimulation electrodes, referred to as stimulation electrodes 744(1), 744(2), and 744(3). The stimulation electrodes 744(1), 744(2), and 744(3) function as an electrical interface for delivery of electrical stimulation signals to the recipient’s vestibular system.
[0082] The stimulating assembly 716 is configured such that a surgeon can implant the stimulating assembly adjacent the recipient’s otolith organs via, for example, the recipient’s oval window. It is to be appreciated that this specific embodiment with three stimulation electrodes is merely illustrative and that the techniques presented herein can be used with
stimulating assemblies having different numbers of stimulation electrodes, stimulating assemblies having different lengths, etc.
[0083] In operation, the vestibular stimulator 712, the external device 704, and/or another external device, can be configured to implement the techniques presented herein. That is, the vestibular stimulator 712, possibly in combination with the external device 704 and/or another external device, can include an evoked biological response analysis system, as described elsewhere herein.
[0084] FIG. 8 illustrates a retinal prosthesis system 801 that comprises an external device 810 (which can correspond to the wearable device) configured to communicate with an implantable retinal prosthesis 800 via signals 851. The retinal prosthesis 800 comprises an implanted processing module 825 and a retinal prosthesis sensor-stimulator 890 is positioned proximate the retina of a recipient. The external device 810 and the processing module 825 can communicate via coils 808, 814.
[0085] In an example, sensory inputs (e.g., photons entering the eye) are absorbed by a microelectronic array of the sensor-stimulator 890 that is hybridized to a glass piece 892 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 890 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.
[0086] The processing module 825 includes an image processor 823 that is in signal communication with the sensor-stimulator 890 via, for example, a lead 888 which extends through surgical incision 889 formed in the eye wall. In other examples, processing module 825 is in wireless communication with the sensor-stimulator 890. The image processor 823 processes the input into the sensor-stimulator 890, and provides control signals back to the sensor-stimulator 890 so the device can provide an output to the optic nerve. That said, in an alternate example, the processing is executed by a component proximate to, or integrated with, the sensor-stimulator 890. The electric charge resulting from the conversion of the incident photons is converted to a proportional amount of electronic current which is input to a nearby retinal cell layer. The cells fire and a signal is sent to the optic nerve, thus inducing a sight perception.
[0087] The processing module 825 can be implanted in the recipient and function by communicating with the external device 810, such as a behind-the-ear unit, a pair of eyeglasses,
etc. The external device 810 can include an external light / image capture device (e.g., located in / on a behind-the-ear device or a pair of glasses, etc.), while, as noted above, in some examples, the sensor-stimulator 890 captures light / images, which sensor-stimulator is implanted in the recipient.
[0088] As should be appreciated, while particular uses of the technology have been illustrated and discussed above, the disclosed technology can be used with a variety of devices in accordance with many examples of the technology. The above discussion is not meant to suggest that the disclosed technology is only suitable for implementation within systems akin to that illustrated in the figures. In general, additional configurations can be used to practice the processes and systems herein and/or some aspects described can be excluded without departing from the processes and systems disclosed herein.
[0089] This disclosure described some aspects of the present technology with reference to the accompanying drawings, in which only some of the possible aspects were shown. Other aspects can, however, be embodied in many different forms and should not be construed as limited to the aspects set forth herein. Rather, these aspects were provided so that this disclosure was thorough and complete and fully conveyed the scope of the possible aspects to those skilled in the art.
[0090] As should be appreciated, the various aspects (e.g., portions, components, etc.) described with respect to the figures herein are not intended to limit the systems and processes to the particular aspects described. Accordingly, additional configurations can be used to practice the methods and systems herein and/or some aspects described can be excluded without departing from the methods and systems disclosed herein.
[0091] According to certain aspects, systems and non-transitory computer readable storage media are provided. The systems are configured with hardware configured to execute operations analogous to the methods of the present disclosure. The one or more non-transitory computer readable storage media comprise instructions that, when executed by one or more processors, cause the one or more processors to execute operations analogous to the methods of the present disclosure.
[0092] Similarly, where 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.
[0093] Although specific aspects were described herein, the scope of the technology is not limited to those specific aspects. One skilled in the art will recognize other aspects or improvements that are within the scope of the present technology. Therefore, the specific structure, acts, or media are disclosed only as illustrative aspects. The scope of the technology is defined by the following claims and any equivalents therein.
[0094] It is also to be appreciated that the embodiments presented herein are not mutually exclusive and that the various embodiments can be combined with another in any of a number of different manners.
Claims
1. A surgical method comprising: performing one or more measurements with one or more electrodes of an implantable medical device of a recipient while the one or more electrodes of the implantable medical device are being inserted during a surgical procedure; and while the one or more electrodes are being inserted, transmitting, by the implantable medical device, data representative of the one or more measurements to an external device via a far field communication link.
2. The surgical method of claim 1, further comprising: powering the implantable medical device with an implantable power source of the implantable medical device while performing the one or more measurements.
3. The surgical method of claim 2, wherein the implantable power source is an implantable battery.
4. The surgical method of claim 2, wherein the implantable power source comprises one or more capacitors configured to be periodically charged by an external power source.
5. The surgical method of claim 1, further comprising: powering the implantable medical device with an external power source.
6. The surgical method of claim 1, 2, 3, 4, or 5, further comprising: delivering acoustic stimulation to an inner ear of the recipient, and wherein performing one or more measurements with the one or more electrodes comprises: performing electrocochleography measurements in response to the stimulation.
7. The surgical method of claim 6. further comprising: sending data representative of the electrocochleography measurements to the external device via the far field communication link.
8. The surgical method of claim 1, 2, 3, 4, or 5, further comprising: receiving, at the implantable medical device, a data packet from the external device via the far field communication link; and triggering performance of the one or more measurements based on the data packet.
9. The surgical method of claim 8, wherein the data packet includes timing information indicating when the one or more measurements are to be performed.
10. The surgical method of claim 9, wherein the timing information comprises a timing offset representing when to initiate the one or more measurements relative to the data packet.
11. The surgical method of claim 1, 2, 3, 4, or 5, further comprising: receiving a sync signal from the external device via the far field communication link, the sync signal including information indicating an offset indicating when the one or more measurements are to be performed; and triggering performance of the one or more measurements based on the sync signal.
12. The surgical method of claim 1, 2, 3, 4, or 5, wherein the one or more measurements are neural response measurements.
13. The surgical method of claim 1, 2, 3, 4, or 5, wherein the one or more measurements are impedance measurements.
14. The surgical method of claim 1, 2, 3, 4, or 5, wherein the far field communication link is a 2.4 GHz link.
15. A surgical method, comprising: capturing one or more neural responses from an inner ear of a recipient of a stimulating assembly of a cochlear implant during insertion of the stimulating assembly into the inner ear; and sending the one or more neural responses directly to an external device via a far-field wireless link.
16. The surgical method of claim 15, wherein capturing the one or more neural responses further comprises: receiving an acoustic signal from an acoustic output device, wherein the acoustic output device receives a signal from the external device over another far-field wireless link to transmit the acoustic signal; delivering stimulation to the inner ear based on receiving the acoustic signal; and capturing the one or more neural responses based on the stimulation.
17. The surgical method of claim 16, further comprising: receiving instructions from the external device to trigger the stimulation; and delivering the stimulation in response to receiving the acoustic signal.
18. The surgical method of claim 17, wherein the instructions include timing information indicating when the stimulation is to be delivered.
19. The surgical method of claim 18, wherein the timing information comprises a timing offset representing when to deliver the stimulation relative to the instructions.
20. The surgical method of claim 15, 16, 17, 18, or 19, further comprising: powering the cochlear implant with an implantable power source.
21. The surgical method of claim 20, wherein the implantable power source is an implantable battery.
22. The surgical method of claim 20, wherein the implantable power source comprises one or more capacitors configured to be periodically charged by an external power source.
23. The surgical method of claim 15, 16, 17, 18, or 19, further comprising: powering the cochlear implant with an external power source.
24. The surgical method of claim 15, 16, 17, 18, or 19, wherein the far-field wireless link is a 2.4 GHz link.
25. A system comprising: an external device; and an implantable component being inserted during a surgical procedure, the implantable component being configured to: perform one or more measurements while the implantable component is being inserted during the surgical procedure, and transmit data representative of the one or more measurements to the external device via a far-field wireless link while the implantable component is being inserted during the surgical procedure.
26. The system of claim 25, wherein the implantable component includes an implantable power source.
27. The system of claim 25, further comprising: an external power source configured to provide power to the implantable component via a power link.
28. The system of claim 25, 26, or 27, further comprising: an acoustic output device configured to receive instructions from the external device over another far-field wireless link; and output an acoustic signal in response to receiving the instructions.
29. The system of claim 28, wherein the implantable component is further configured to: receive the acoustic signal; receive instructions from the external device over the far-field wireless link to perform the one or more measurements; and perform the one or more measurements based on receiving the acoustic signal and the instructions to perform the one or more measurements from the external device.
30. The system of claim 25, 26, or 27, wherein the one or more measurements are neural response measurements.
31. The system of claim 25, 26, or 27, wherein the one or more measurements are impedance measurements.
32. The system of claim 25, 26, or 27, wherein the far-field wireless link is a 2.4 GHz link.
33. One or more non-transitory computer readable storage media comprising instructions that, when executed by a processor of an implantable medical device of a recipient, cause the processor to: perform one or more measurements with one or more electrodes of the implantable medical device while the one or more electrodes are being inserted into the recipient during a surgical procedure; and while the one or more electrodes are being inserted, transmit data representative of the one or more measurements to an external device via a far field communication link.
34. The one or more non-transitory computer readable storage media of claim 33, wherein the implantable medical device includes an implantable power source.
35. The one or more non-transitory computer readable storage media of claim 33, wherein the implantable medical device receives power from an external power source.
36. The one or more non-transitory computer readable storage media of claim 33, 34, or 35, wherein the instructions further cause the processor to deliver stimulation to an inner ear of the recipient, and wherein the instructions that cause the processor to perform the one or more measurements include instructions that cause the processor to perform electrocochleography measurements in response to the stimulation.
37. The one or more non-transitory computer readable storage media of claim 33, 34, or 35, wherein the instructions further cause the processor to trigger performance of the one or more measurements based on a data packet received from the external device via the far field communication link.
38. The one or more non-transitory computer readable storage media of claim 37, wherein the data packet includes timing information indicating when the one or more measurements are to be performed.
39. The one or more non-transitory computer readable storage media of claim 38, wherein the timing information comprises a timing offset representing when to initiate the one or more measurements relative to the data packet.
40. The one or more non-transitory computer readable storage media of claim 33, 34, or 35, wherein the instructions further cause the processor to trigger performance of the one or more measurements based on receiving a sync signal from the external device via the far field communication link, the sync signal including information indicating an offset indicating when the one or more measurements are to be performed.
41. An implantable component, comprising : a stimulating assembly comprising one or more electrodes; measurement circuitry configured to use the one or more electrodes to perform one or more measurements while the implantable component is being implanted in a recipient; and a far-field wireless transceiver configured to transmit data representative of the one or more measurements to an external device via a far-field wireless link while the implantable component is being implanted in the recipient.
42. The implantable component of claim 41, further comprising an implantable power source.
43. The implantable component of claim 41 or 42, wherein the one or more measurements are neural response measurements.
44. The implantable component of claim 41 or 42, wherein the one or more measurements are impedance measurements.
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| US202363608559P | 2023-12-11 | 2023-12-11 | |
| US63/608,559 | 2023-12-11 |
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| WO2025125987A1 true WO2025125987A1 (en) | 2025-06-19 |
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| PCT/IB2024/062215 Pending WO2025125987A1 (en) | 2023-12-11 | 2024-12-04 | Interoperative measurements |
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| US20050131272A1 (en) * | 2003-12-11 | 2005-06-16 | Bernd Waldmann | Electrophysiological measurement method and system for positioning an implantable, hearing instrument transducer |
| US20160001075A1 (en) * | 2013-01-30 | 2016-01-07 | Les Hôpitaux Universitaires De Genéve | Device and method for electrical stimulation of neural or muscular tissue |
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