System and method for determining an insertion state of an electrode lead during electrode lead insertion

Abstract

An example diagnostic system is configured to: direct an acoustic stimulus generator to apply acoustic stimuli having a plurality of stimulus frequencies to a recipient of a cochlear implant during an insertion procedure in which an electrode lead communicatively coupled to the cochlear implant is inserted into a cochlea of the recipient; direct the cochlear implant to record, using electrodes disposed on the electrode lead, a plurality of evoked response signals during the insertion procedure, each evoked response signal included in the plurality of evoked response signals corresponding to a different stimulus frequency included in the plurality of stimulus frequencies; and determine an insertion status of the electrode lead within the cochlea of the recipient based on an amplitude and a phase of each of one or more evoked response signals included in the plurality of evoked response signals.

Description

[0001] Related applications

[0002] This application claims priority to PCT International Application No. PCT / US2019 / 041136, filed on July 10, 2019, the entire contents of which are hereby incorporated by reference.

[0003] Background Information

[0004] During the insertion process of placing electrode leads into the cochlea, it is desirable to have certain information about the insertion status of the electrode leads. For example, it is desirable to determine and communicate in real time to the surgeon performing the insertion process when the electrodes on the electrode leads pass through specific characteristic frequency positions within the cochlea, when the electrodes on the electrode leads are near hair cell clusters, and / or when the electrode leads may be causing trauma to the cochlear structure. Attached Figure Description

[0005] The accompanying drawings illustrate different embodiments and are part of this specification. The illustrated embodiments are merely examples and do not limit the scope of this disclosure. Throughout the drawings, the same or similar reference numerals denote the same or similar elements.

[0006] Figure 1 The illustration shows an exemplary cochlear implantation system based on the principles described herein.

[0007] Figure 2 Illustration Figure 1 An exemplary configuration of a cochlear implantation system.

[0008] Figure 3 The illustration shows an exemplary diagnostic system based on the principles described herein.

[0009] Figure 4-5 The diagram is based on the principles described in this article. Figure 3 An exemplary implementation of a diagnostic system.

[0010] Figures 6A-6F The illustration shows an exemplary insertion process for inserting electrode leads into the cochlea of ​​the recipient, based on the principles described herein.

[0011] Figure 7-11 A graph showing the induced response signals that can be generated according to the principles described herein.

[0012] Figure 12 The illustration shows an exemplary method based on the principles described herein.

[0013] Figure 13 The illustration shows an exemplary computing device based on the principles described herein. Detailed Implementation

[0014] This document describes systems and methods for determining the insertion status of an electrode lead during an insertion process using one or more evoked response signals. For example, a diagnostic system may guide an acoustic stimulation generator to apply acoustic stimulation with multiple stimulation frequencies to the recipient of the cochlear implant during the insertion process, in which an electrode lead communicatively coupled to the cochlear implant is inserted into the recipient's cochlea. The diagnostic system may guide the cochlear implant to record multiple evoked response signals using electrodes positioned on the electrode lead during the insertion process. Each evoked response signal included in the multiple evoked response signals may correspond to a different stimulation frequency included in the multiple stimulation frequencies and may represent an evoked response occurring within the recipient in response to the acoustic stimulation applied to the recipient. The evoked responses may each be cochlear electrogram (“ECoG”) potentials (e.g., cochlear microphonic potentials, action potentials, summation potentials, etc.), auditory nerve responses, brainstem responses, complex action potentials, stapedius muscle reflexes, and / or any other type of neural or physiological response that may occur within the recipient in response to the acoustic stimulation applied to the recipient. The induced response can originate from nerve tissue, hair cells to nerve synapses, inner or outer hair cells, or other sources.

[0015] As will be described herein, properties associated with evoked response signals recorded by the electrodes can indicate the insertion state of the electrode lead within the recipient cochlea. For example, the amplitude and / or phase of one or more evoked response signals can indicate a specific insertion state. As used herein, "insertion state" can correspond to any of a plurality of different insertion states associated with the insertion of the electrode lead into the recipient cochlea. For example, one or more insertion states can be associated with a characteristic frequency location passing through the cochlea, passing through hair cells or neuronal clusters, contacting structures of the cochlea (e.g., the basilar membrane), causing trauma to the cochlea (e.g., crossing the basilar membrane), etc. Accordingly, a diagnostic system can determine the insertion state of the electrode lead within the recipient cochlea based on the amplitude and phase of each of one or more evoked response signals included in a plurality of evoked response signals.

[0016] By using acoustic stimulation with multiple stimulation frequencies to facilitate the determination of insertion status, the systems and methods described herein optimize the determination of insertion status and / or facilitate the determination of alternative or secondary insertion statuses compared to conventional methods. Furthermore, the systems and methods described herein can be used to provide real-time feedback to the user performing the insertion procedure (e.g., a surgeon) to ensure proper placement of the electrode leads within the recipient's cochlea. These and other benefits and advantages of the systems and methods described herein will become apparent herein.

[0017] Figure 1The figure illustrates an exemplary cochlear implant system 100 configured for use by a recipient. As shown, the cochlear implant system 100 includes a cochlear implant 102, electrode leads 104, and a controller 108. The electrode leads are physically coupled to the cochlear implant 102 and have an array of electrodes 106, and the controller is configured to be communicatively coupled to the cochlear implant 102 via a communication link 110.

[0018] Figure 1 The cochlear implant system 100 shown is unilateral (i.e., associated with only one ear of the recipient). Alternatively, a bilateral configuration of the cochlear implant system 100 may include separate cochlear implants and electrode leads for each ear of the recipient. In a bilateral configuration, the controller 108 may be implemented by a single controller configured to interface with both cochlear implants or by two separate controllers each configured to interface with different of the cochlear implants.

[0019] The cochlear implant 102 can be implemented by any suitable type of implantable stimulator. For example, the cochlear implant 102 can be implemented by an implantable cochlear stimulator. Alternatively or alternatively, the cochlear implant 102 can be implemented by a brainstem implant and / or any other type of device that is implantable in the recipient and configured to apply electrical stimulation to one or more stimulation sites located along the recipient's auditory pathway.

[0020] In some examples, the cochlear implant 102 may be configured to generate electrical stimulation representing an audio signal processed by the controller 108, based on one or more stimulation parameters sent to the cochlear implant 102 by the controller 108. The cochlear implant 102 may also be configured to apply electrical stimulation to one or more stimulation sites within the recipient body (e.g., one or more intracochlear locations) via one or more electrodes 106 on the electrode leads 104. In some examples, the cochlear implant 102 may include multiple independent current sources, each associated with a channel defined by one or more of the electrodes 106. In this manner, different stimulation current levels may be simultaneously applied to multiple stimulation sites via multiple electrodes 106.

[0021] The cochlear implant 102 may additionally or alternatively be configured to generate, store, and / or transmit data. For example, the cochlear implant may use one or more electrodes 106 to record one or more signals (e.g., one or more voltages, impedances, evoked responses in the recipient body, and / or other measurements) and transmit data representing said one or more signals to a controller 108 via a communication link 110. In some examples, this data is referred to as back telemetry data.

[0022] The electrode lead 104 can be implemented in any suitable manner. For example, the distal portion of the electrode lead 104 can be pre-bent so that the implanted electrode lead 104 follows the spiral shape of the cochlea. Alternatively, the electrode lead 104 can be naturally straight or have any other suitable configuration.

[0023] In some examples, electrode leads 104 include multiple wires (e.g., within an outer sheath) that conductively connect electrodes 106 to one or more current sources within the cochlear implant 102. For example, if there are n electrodes 106 on electrode leads 104 and n current sources within the cochlear implant 102, then n individual wires may be provided within electrode leads 104, the n individual wires being configured to conductively connect each electrode 106 to different of the n current sources. Exemplary values ​​for n are 8, 12, 16, or any other suitable number.

[0024] Electrode 106 is located at least on the distal portion of electrode lead 104. In this configuration, after the distal portion of electrode lead 104 is inserted into the cochlea, electrical stimulation can be applied to one or more intracochlear locations via one or more electrodes 106. One or more other electrodes (e.g., including a ground electrode, not explicitly shown) are also disposed on other portions of electrode lead 104 (e.g., on the proximal portion of electrode lead 104) to provide a current return path for the stimulation current applied by electrode 106 and to remain outside the cochlea after the distal portion of electrode lead 104 is inserted into the cochlea. Alternatively or additionally, the housing of cochlear implant 102 may be used as a ground electrode for the stimulation current applied by electrode 106.

[0025] Controller 108 may be configured to interface with cochlear implant 102 (e.g., to control the cochlear implant and / or receive data from it). For example, controller 108 may send commands to cochlear implant 102 via communication link 110 (e.g., stimulation parameters and / or other types of operational parameters in the form of data words included in a forward telemetry sequence). Controller 108 may also additionally or alternatively provide operational power to cochlear implant 102 by sending one or more power signals to cochlear implant 102 via communication link 110. Additionally or alternatively, controller 108 may also receive data from cochlear implant 102 via communication link 110. Communication link 110 may be implemented by any suitable number of wired and / or wireless bidirectional and / or unidirectional links.

[0026] As shown in the figure, controller 108 includes a memory 112 and a processor 114 configured to be selectively and communicatively coupled to each other. In some examples, the memory 112 and processor 114 may be distributed across multiple devices and / or multiple locations, as may be for a particular implementation.

[0027] Memory 112 may be implemented by any suitable non-transitory computer-readable medium and / or non-transitory processor-readable medium, such as any combination of non-volatile storage media and / or volatile storage media. Exemplary non-volatile storage media include, but are not limited to, read-only memory, flash memory, solid-state drives, magnetic storage devices (e.g., hard disk drives), ferromagnetic random access memory (“RAM”), and optical discs. Exemplary volatile storage media include, but are not limited to, RAM (e.g., dynamic RAM).

[0028] Memory 112 may maintain (e.g., store) executable data used by processor 114 to perform one or more operations described herein. For example, memory 112 may store instructions 116 that may be executed by processor 114 to perform any of the operations described herein. Instructions 116 may be implemented by any suitable application, program (e.g., a sound processing program), software, code, and / or other executable data instance. Memory 112 may also maintain any data received, generated, managed, used, and / or sent by processor 114.

[0029] Processor 114 can be configured to implement (e.g., execute instructions 116 stored in memory 112 to implement) various operations for cochlear implant 102.

[0030] For illustration, processor 114 may be configured to control the operation of cochlear implant 102. For example, processor 114 may receive audio signals (e.g., via a microphone, wireless interface (e.g., Bluetooth interface), and / or wired interface (e.g., auxiliary input port) communicatively coupled to controller 108). Processor 114 may process the audio signals according to an acoustic processing program (e.g., an acoustic processing program stored in memory 112) to generate appropriate stimulation parameters. Processor 114 may then send the stimulation parameters to cochlear implant 102 to guide cochlear implant 102 to apply electrical stimulation representing the audio signal to the recipient.

[0031] In some implementations, processor 114 may also be configured to apply acoustic stimulation to the receptor. For example, a receiver (also referred to as a loudspeaker) may be optionally coupled to controller 108. In this configuration, processor 114 may deliver acoustic stimulation to the receptor via the receiver. The acoustic stimulation may represent an audio signal configured to elicit an evoked response in the receptor and / or otherwise configured (e.g., an amplified version of an audio signal). In a configuration in which processor 114 is configured to both deliver acoustic stimulation to the receptor and guide cochlear implant 102 to apply electrical stimulation to the receptor, cochlear implant system 100 may be referred to as a bimodal hearing system and / or any other suitable term.

[0032] The processor 114 may additionally or alternatively be configured to receive and process data generated by the cochlear implant 102. For example, the processor 114 may receive data representing signals recorded by the cochlear implant 102 using one or more electrodes 106 and adjust one or more operating parameters of the controller 108 based on the data. Additionally or alternatively, the processor 114 may use the data to perform one or more diagnostic operations on the cochlear implant 102 and / or the recipient.

[0033] Other operations may also be performed by processor 114, such as those servicing a particular implementation. In the description provided herein, any reference to operations performed by controller 108 and / or any implementation thereof shall be understood as being performed by processor 114 based on instructions 116 stored in memory 112.

[0034] The controller 108 may be implemented by one or more devices configured to interface with the cochlear implant 102. For illustration purposes, Figure 2 An exemplary configuration 200 of a cochlear implant system 100 is shown, in which a controller 108 is implemented by a sound processor 202 configured to be located outside the recipient body. In configuration 200, the sound processor 202 is communicatively coupled to a microphone 204 and communicatively coupled to a headpiece 206, both of which are configured to be located outside the recipient body.

[0035] The sound processor 202 can be implemented by any suitable device that can be worn or carried by the recipient. For example, the sound processor 202 can be implemented by an behind-the-ear (“BTE”) unit configured to be worn behind and / or on top of the recipient’s ear. Alternatively, the sound processor 202 can be implemented by an off-the-ear unit (also known as a body-worn device) configured to be worn or carried by the recipient remotely from the ear. Alternatively, at least a portion of the sound processor 202 is implemented by circuitry within the headpiece 206.

[0036] Microphone 204 is configured to detect one or more audio signals (e.g., speech and / or any other type of sound) in the recipient's environment. Microphone 204 can be implemented in any suitable manner. For example, microphone 204 can be implemented by a microphone configured to be placed in the outer ear near an entrance to the ear canal, such as the T-MIC from AdvancedBionics. TMMicrophone. Such a microphone can be held in the outer ear near the entrance of the ear canal during normal operation by means of a stalk or stem attached to an ear hook, the ear hook being configured to selectively attach to the sound processor 202. Alternatively or additionally, the microphone 204 may also be implemented by one or more microphones in or on the headpiece 206, one or more microphones in or on the housing of the sound processor 202, one or more beamforming microphones, and / or any other suitable microphone that may serve a particular implementation.

[0037] Headpiece 206 may be selectively and communicatively coupled to sound processor 202 via communication link 208 (e.g., cable or any other suitable wired or wireless communication link), which may be implemented in any suitable manner. Headpiece 206 may include an external antenna (e.g., coil and / or one or more wireless communication components) configured to facilitate selective wireless coupling of sound processor 202 to cochlear implant 102. Alternatively or additionally, headpiece 206 may be used to selectively and wirelessly couple any other external device to cochlear implant 102. For this purpose, headpiece 206 may be configured to attach to the recipient's head and positioned such that an external antenna housed within headpiece 206 is communicatively coupled to a corresponding implantable antenna included within or otherwise connected to cochlear implant 102 (which may also be implemented by a coil and / or one or more wireless communication components). In this manner, stimulation parameters and / or power signals may be transmitted wirelessly and transdermally between sound processor 202 and cochlear implant 102 via wireless communication link 210.

[0038] In configuration 200, the sound processor 202 can receive the audio signal detected by the microphone 204 by receiving a signal (e.g., an electrical signal) representing an audio signal from the microphone 204. The sound processor 202 can also receive the audio signal additionally or alternatively via any other suitable interface described herein. The sound processor 202 can process the audio signal in any manner described herein and send stimulation parameters via the headpiece 206 to the cochlear implant 102 to guide the cochlear implant 102 to apply electrical stimulation representing the audio signal to the recipient.

[0039] In an alternative configuration, the sound processor 202 may be implanted within the recipient body rather than located outside the recipient body. In this alternative configuration (which may also be referred to as a fully implantable configuration of the cochlear implant system 100), the sound processor 202 and the cochlear implant 102 may be combined into a single device or implemented as separate devices configured to communicate with each other via wired and / or wireless communication links. In a fully implantable implementation of the cochlear implant system 100, the headpiece 206 may be omitted, and the microphone 204 may be implemented by one or more microphones implanted within the recipient body, located within the recipient's ear canal, and / or located outside the recipient body.

[0040] Figure 3 The figure illustrates an exemplary diagnostic system 300, which can be configured to perform any of the operations described herein. As shown, the diagnostic system 300 may include, but is not limited to, storage facility 302 and processing facility 304 selectively and communicatively coupled to each other. Facilities 302 and 304 may each include or be implemented by hardware and / or software components (e.g., processor, memory, communication interface, instructions stored in memory for execution by the processor, etc.). In some examples, facilities 302 and 304 may be distributed among multiple devices and / or multiple locations, as may serve a particular implementation.

[0041] Storage facility 302 may maintain (e.g., store) executable data that is used by processing facility 304 to perform any of the operations described herein. For example, storage facility 302 may store instructions 306 that can be executed by processor facility 304 to perform any of the operations described herein. Instructions 306 may be implemented by any suitable application, software, code, and / or other instance of executable data. Storage facility 302 may also maintain any data received, generated, managed, used, and / or sent by processing facility 304.

[0042] Processing facility 304 may be configured to perform (e.g., execute instructions 306 stored in storage facility 302 to perform) various operations. For example, processing facility 304 may direct an acoustic stimulation generator to apply acoustic stimulation having multiple stimulation frequencies to the recipient of the cochlear implant during an insertion process in which an electrode lead communicatively coupled to the cochlear implant is inserted into the recipient's cochlea; direct the cochlear implant to record multiple evoked response signals during the insertion process using electrodes positioned on the electrode lead, each of the multiple evoked response signals corresponding to a different stimulation frequency included in the multiple stimulation frequencies and representing an evoked response occurring within the recipient in response to the acoustic stimulation applied to the recipient; and determine the insertion state of the electrode lead within the recipient's cochlea based on the amplitude and phase of each of one or more of the multiple evoked response signals. These and other operations that may be performed by processing facility 304 are described in more detail herein.

[0043] The diagnostic system 300 can be implemented in any suitable manner. For example, Figure 4 An exemplary configuration is shown in which the diagnostic system 300 is implemented by a computing system 402 configured to be communicatively coupled to the sound processor 202. As shown, the computing system 402 may include an acoustic stimulus generator 404 communicatively coupled to a speaker 406. The computing system 402 is also communicatively coupled to a display device 408. Although the computing system 402 is described herein as being coupled to the sound processor 202, the computing system 402 may alternatively be coupled to a controller 108 of any other implementation, as may be servicing a particular implementation.

[0044] The computing system 402 may be implemented by any suitable combination of hardware (e.g., one or more computing devices) and software. For example, the computing system 402 may be implemented by a computing device programmed to perform one or more fitting operations for a recipient of a cochlear implant. For illustration, the computing system 402 may be implemented by a desktop computer, a mobile device (e.g., a laptop computer, a smartphone, a tablet computer, etc.), and / or any other suitable computing device that serves a particular implementation. As an example, the computing system 402 may be implemented by a mobile device configured to execute an application (e.g., a “mobile app”) that can be used by a user (e.g., a recipient, a clinician, and / or any other user) to control one or more settings of the sound processor 202 and / or the cochlear implant 102 and / or to perform one or more operations (e.g., diagnostic operations) on data generated by the sound processor 202 and / or the cochlear implant 102.

[0045] The acoustic stimulus generator 404 can be implemented by any suitable combination of components configured to generate acoustic stimuli. In some examples, the acoustic stimulus may include one or more tones having one or more stimulus frequencies. Alternatively, the acoustic stimulus may also include any other type of acoustic content having at least one particular stimulus frequency of interest. The speaker 406 can be configured to deliver the acoustic stimulus generated by the acoustic stimulus generator 404 to the recipient. For example, the speaker 406 can be implemented by an ear mold configured to be placed in or near the entrance of the recipient's ear canal.

[0046] The display device 408 can be implemented by any suitable device configured to display graphical content generated by the computing system 402. For example, the display device 408 can display one or more graphs of induced responses recorded by electrodes disposed on electrode leads 104. The display device 408 in Figure 4 The device shown is an external device configured to display content generated by the computing system 402. Alternatively, in some implementations, the computing system 402 may also include a display device 408 as an integrated display.

[0047] Figure 5 Another exemplary configuration 500 is shown, in which the diagnostic system 400 is implemented by the computing system 402. In configuration 500, an acoustic stimulation generator 404 is included in the acoustic processor 202. For example, the acoustic processor 202 may be implemented by a dual acoustic processor (i.e., an acoustic processor configured to guide the cochlear implant 102 to apply electrical stimulation to the receptor and to guide the acoustic stimulation generator 404 to apply acoustic stimulation to the receptor). In some examples, a speaker 406 may be implemented by an audio ear hook connected to the acoustic processor 202.

[0048] Figures 6A-6F The diagram illustrates an exemplary insertion process in which electrode leads 600 are inserted into the cochlea 602 of the recipient. For illustrative purposes, the cochlea 602 is... Figures 6A-6F The shape is depicted as "unfolded" rather than its actual curved, spiral shape. Electrode lead 600 may be similar to electrode lead 104 and may include multiple electrodes disposed thereon (e.g., electrodes 604-1 to 604-16). Electrode 604-1 is the farthest electrode on electrode lead 600, and electrode 604-16 is the nearest electrode on electrode lead 600.

[0049] The positions of various characteristic frequencies within the cochlea 602 are shown by vertical dashed lines. Figures 6A-6FIn each of these locations, as shown in the figure, the first characteristic frequency position is associated with 4 kHz. Therefore, electrical stimulation applied by an electrode positioned at this characteristic frequency position can cause the receptor to perceive a sound of 4 kHz, or the hair cells or neural structures at this location to respond to an acoustic stimulus of 4 kHz. Figures 6A-6F The locations of characteristic frequencies associated with 2 kHz, 1 kHz, 500 Hz, and 250 Hz are also plotted. As shown in the figure, the frequencies associated with the characteristic frequency locations are arranged in a tonal topology, with relatively higher frequencies located toward the entrance (or base) of the cochlea 602 and relatively lower frequencies located toward the distal end (or apex) of the cochlea 602.

[0050] Figure 6A The electrode lead 600 that enters the cochlea 602 is shown. In this figure, electrode 604-1 is barely positioned within the cochlea 602. Figure 6B The electrode lead 600 is shown after it has been further advanced into the cochlea 602 so that the electrode 604-1 is located at a position corresponding to a characteristic frequency of 4 kHz. Figure 6C-6F This shows that the electrode lead 600 has been further advanced into the cochlea 602 such that the electrode 604-1 is located at a frequency corresponding to 2 kHz ( Figure 6C ), then 1 kHz ( Figure 6D ), then 500 Hz ( Figure 6E ) and then 250 Hz ( Figure 6F The electrode lead 600 is located after the characteristic frequency position of the electrode.

[0051] As mentioned, it is desirable to monitor the insertion status of the electrode leads during insertion into the cochlea to ensure proper insertion. To this end, the diagnostic system 300 may guide an acoustic stimulator (e.g., acoustic stimulator 404) to apply acoustic stimuli with multiple stimulation frequencies (i.e., concurrently) to the recipient of the cochlear implant during the insertion process, in which the electrode leads, communicatively coupled to the cochlear implant, are inserted into the recipient's cochlea. The diagnostic system 300 may guide the acoustic stimulator to apply acoustic stimuli with multiple stimulation frequencies in any suitable manner. For example, the diagnostic system 300 may guide the acoustic stimulator to apply acoustic stimuli continuously during the insertion process, intermittently during the insertion process, simultaneously apply different stimulation frequencies of acoustic stimuli during the insertion process, sequentially apply different stimulation frequencies of acoustic stimuli during the insertion process, or apply acoustic stimuli in any other suitable manner that serves a particular implementation.

[0052] The acoustic stimulus may have any suitable number of stimulus frequencies to serve a particular implementation. In some examples, the acoustic stimulus may have four different stimulus frequencies, which are applied concurrently during the insertion process. For example, in some implementations, the acoustic stimulus may include a first stimulus frequency corresponding to 2 kHz, a second stimulus frequency corresponding to 1 kHz, a third stimulus frequency corresponding to 500 Hz, and a fourth stimulus frequency corresponding to 250 Hz. In some alternative implementations, the acoustic stimulus may have fewer than or more than four stimulus frequencies.

[0053] Acoustic stimulation is configured to generate multiple evoked responses during insertion, which are useful in determining the insertion state. Accordingly, diagnostic system 300 can guide cochlear implant 102 to record multiple evoked response signals using electrodes during insertion. Diagnostic system 300 can guide cochlear implant 102 to record multiple evoked response signals using any suitable electrode or electrode combination on the electrode leads. For example, in some implementations, diagnostic system 300 can guide cochlear implant to record multiple evoked response signals using the most distal electrode (e.g., electrode 604-1). Each evoked response signal included in the multiple evoked response signals may correspond to a different stimulation frequency included in a plurality of stimulation frequencies. Furthermore, each evoked response signal included in the multiple evoked response signals may represent an evoked response occurring within the recipient in response to acoustic stimulation applied to the recipient.

[0054] In some examples, multiple evoked response signals may be considered as part of a single evoked response detected by the diagnostic system 300 in response to an acoustic stimulus applied to the receptor.

[0055] The properties of multiple evoked response signals can indicate the insertion state of the electrode leads as they are inserted into the cochlea. For example, as the electrode leads are inserted into the cochlea, the amplitude and / or phase of one or more of the multiple evoked response signals may change in a manner that indicates a specific insertion state of the electrode leads. Accordingly, based on the amplitude and phase of each of the one or more evoked response signals included in the multiple evoked response signals, the diagnostic system 300 can determine the insertion state of the electrode leads in the recipient's cochlea.

[0056] The diagnostic system 300 can determine any suitable number and / or type of insertion states that can serve a particular implementation. In some examples, the insertion state may correspond to a specific characteristic frequency position within the cochlea where the electrode lead passes. In such an example, the diagnostic system 300 can determine that the electrode lead has passed a specific characteristic frequency position when, within a predetermined time period, the amplitude of a specific evoked response signal included in a plurality of evoked response signals decreases by at least an amplitude threshold amount and the phase of the specific evoked response signal also changes by at least a phase threshold amount. The specific characteristic frequency position may correspond to a specific stimulation frequency, which corresponds to a specific evoked response signal and is included in the plurality of stimulation frequencies. Accordingly, the diagnostic system 300 can determine that the insertion state has passed a certain characteristic frequency position based on both the amplitude decrease of the evoked response signal having at least an amplitude threshold amount and the phase change having at least a phase threshold amount.

[0057] For the purpose of explanation, Figure 7 An exemplary lead insertion process for advancing electrode lead 600 into cochlea 602 is illustrated. Reference numerals P1 to P3 indicate the positions of electrode lead 600. For example, at position P1, electrode lead 600 is in a first position, where electrode 604-1 is located at a characteristic frequency corresponding to 2 kHz. At position P2, electrode lead 600 is in a second position, where electrode 604-1 is located at a characteristic frequency corresponding to 1 kHz. At position P3, electrode lead 600 is in a third position, where electrode 604-1 is located at a characteristic frequency corresponding to 500 Hz.

[0058] Figure 7 A graph 702 also shows the amplitudes 706 (e.g., amplitudes 706-1 to 706-3) of the induced response signals recorded by electrode 604-1 at different insertion times T (e.g., T1 to T3) during the lead insertion process. Furthermore, Figure 7Graph 704 shows the phases 708 (e.g., phases 708-1 to 708-3) of the evoked response signals recorded by electrode 604-1 at different insertion times T during the lead insertion process. In this example, the first, second, and third evoked response signals are generated in response to acoustic stimuli having stimulation frequencies of 2 kHz, 1 kHz, and 500 Hz, respectively. Therefore, as shown in Graph 702, as electrode lead 600 advances toward the characteristic frequency position corresponding to 2 kHz, the amplitude 706-1 of the first evoked response signal (which is generated in response to acoustic stimuli having a stimulation frequency of 2 kHz) increases and reaches its peak at insertion time T1 when electrode lead 600 is positioned at position P1. As electrode lead 600 passes the characteristic frequency position corresponding to 2 kHz, the amplitude 706 of the first evoked response decreases until it stabilizes at a steady-state value. As shown in Graph 704, as electrode lead 600 advances toward the characteristic frequency position corresponding to 2 kHz, the phase 708-1 of the first evoked response signal remains at a relatively high level. However, at the insertion moment T1 when electrode lead 600 passes through the characteristic frequency position corresponding to 2 kHz, phase 708-1 suddenly changes to a relatively low level.

[0059] like Figure 7 As shown, the decrease in the amplitude 706-1 of the first evoked response and the change in phase 708-1 from a high level to a low level occur at approximately the same insertion time T1, and both occur when electrode 604-1 passes through a characteristic frequency position corresponding to 2 kHz. Therefore, the diagnostic system 300 can determine the position of electrode 604-1 passing through a characteristic frequency position corresponding to 2 kHz by detecting a decrease in the amplitude 706-1 of the first evoked response signal recorded by electrode 604-1 by at least an amplitude threshold amount and a change in the phase 708-1 of the first evoked response signal recorded by electrode 604-1 by at least a phase threshold amount within a predetermined time period. The predetermined time period, amplitude threshold amount, and / or phase threshold amount can each be set by the diagnostic system 300 to any suitable value. For example, the predetermined time period can be set to a relatively short period (e.g., less than a few milliseconds) to ensure that the amplitude change and phase change correspond to each other. In some examples, the diagnostic system 300 can set the predetermined time period, amplitude threshold amount, and / or phase threshold amount in response to user input (e.g., via a graphical user interface). Alternatively, the diagnostic system 300 may automatically set the predetermined time period, amplitude threshold, and / or phase threshold based on one or more factors such as hearing loss, stimulation frequency, and receptor characteristics (e.g., age, gender, etc.).

[0060] like Figure 7As further illustrated, after electrode lead 600 passes the characteristic frequency position corresponding to 2 kHz, electrode lead 600 advances towards the characteristic frequency position corresponding to 1 kHz. As electrode lead 600 advances towards the characteristic frequency position corresponding to 1 kHz, the amplitude 706-2 of the second evoked response signal (which is generated in response to an acoustic stimulus with a stimulus frequency of 1 kHz) increases and reaches its peak at insertion time T2 when electrode lead 600 is positioned at position P2. As electrode lead 600 passes the characteristic frequency position corresponding to 1 kHz, the amplitude 706-2 of the second evoked response decreases until it stabilizes at a steady-state value. As shown in Table 704, as electrode lead 600 advances towards the characteristic frequency position corresponding to 1 kHz, the phase 708-2 of the second evoked response signal remains at a relatively high level. However, at insertion time T2 when electrode lead 600 passes the characteristic frequency position corresponding to 1 kHz, phase 708-2 suddenly changes to a relatively low level.

[0061] Figure 7 The decrease in the amplitude 706-2 of the second evoked response and the change in phase 708-2 from a high level to a low level occur at approximately the same insertion time T2, and both occur when electrode 604-1 passes through a characteristic frequency position corresponding to 1 kHz. Therefore, the diagnostic system 300 can determine the position of electrode 604-1 passing through a characteristic frequency position corresponding to 1 kHz by detecting a decrease in the amplitude 706-2 of the second evoked response signal recorded by electrode 604-1 by at least an amplitude threshold amount and a change in the phase 708-2 of the second evoked response signal recorded by electrode 604-1 by at least a phase threshold amount within a further predetermined time period. The further predetermined time period, amplitude threshold amount, and / or phase threshold amount can each be set by the diagnostic system 300 to any suitable value, as described herein.

[0062] like Figure 7As further illustrated, after electrode lead 600 passes the characteristic frequency position corresponding to 1 kHz, electrode lead 600 advances towards the characteristic frequency position corresponding to 500 Hz. As electrode lead 600 advances towards the characteristic frequency position corresponding to 500 Hz, the amplitude 706-3 of the third evoked response signal (which is generated in response to an acoustic stimulus with a stimulation frequency of 500 Hz) increases and reaches its peak at insertion time T3 when electrode lead 600 is positioned at position P3. As electrode lead 600 passes the characteristic frequency position corresponding to 500 Hz, the amplitude 706-3 of the third evoked response decreases until it stabilizes at a steady-state value. As shown in Table 704, as electrode lead 600 advances towards the characteristic frequency position corresponding to 500 Hz, the phase 708-3 of the third evoked response signal remains at a relatively high level. However, at insertion time T3 when electrode lead 600 passes the characteristic frequency position corresponding to 500 Hz, phase 708-3 suddenly changes to a relatively low level.

[0063] Figure 7 The decrease in amplitude 706-3 and the change in phase 708-3 from a high level to a low level of the third evoked response occur at approximately the same insertion time T3, and both occur when electrode 604-1 passes through the characteristic frequency position corresponding to 500 Hz. Therefore, the diagnostic system 300 can determine that electrode 604-1 has passed through the characteristic frequency position corresponding to 500 Hz by detecting, within a further predetermined time period, a decrease in amplitude 706-3 of the third evoked response signal recorded by electrode 604-1 by at least an amplitude threshold amount and a change in phase 708-3 of the third evoked response signal recorded by electrode 604-1 by at least a phase threshold amount. The further predetermined time period, amplitude threshold amount, and / or phase threshold amount can each be set by the diagnostic system 300 to any suitable value, as described herein.

[0064] In some examples, the diagnostic system 300 may perform operations similar to those described herein to determine when the electrode leads pass through other characteristic frequency locations corresponding to other frequencies (e.g., 4 kHz, 250 Hz, etc.).

[0065] In some examples, the diagnostic system 300 may determine the characteristic frequency through which the electrode lead 600 passes based on at least one of the following: the amplitude of an additional evoked response signal included in a plurality of evoked response signals does not decrease by at least an amplitude threshold amount, and the phase of said additional evoked response signal does not change by at least a phase threshold amount. For example, in addition to the amplitude threshold amount and phase threshold amount changing of the amplitude 706-2 and phase 708-3 of the second evoked response signal at insertion time T2, the diagnostic system 300 may also determine the position of the electrode lead 600 passing through a characteristic frequency corresponding to 1 kHz based on the fact that the amplitude 706-3 of the third evoked response signal at insertion time T2 does not decrease by an amplitude threshold amount and / or the phase 708-3 does not change by at least a phase threshold amount.

[0066] exist Figure 7 In this illustration, for clarity, various aspects of the anatomical features of the electrode leads and the illustrated receptors are simplified. For example, although the cochlea 602 is... Figure 7 The diagram is already "unfolded," but it will be understood that the cochlea 602 has a curved, spiral structure, and the electrode leads 600 are bent to follow this spiral structure. Similarly, the anatomy of the cochlea 602 is omitted in many details and is not drawn to scale.

[0067] However, Figure 7 A diagram illustrates at least one additional structure associated with the insertion state that can be determined by the diagnostic system 300. Specifically, Figure 7 A basilar membrane 710 extending along the length of the cochlea 602 is also shown. When the electrode lead 600 is inserted along the cochlea 602, the electrode lead 600 may contact structures of the cochlea 602, such as the basilar membrane 710. In such an example, the diagnostic system 300 may determine that the electrode lead 600 is in contact with a structure of the cochlea 602 when the amplitude of at least two of the evoked response signals included in a plurality of evoked response signals has decreased by at least an amplitude threshold amount and the phase of the at least two evoked response signals has changed by at least a phase threshold amount.

[0068] In some alternative examples, the diagnostic system 300 can determine structural contact between the electrode lead 600 and the cochlea 602 when the amplitude of each of the multiple evoked response signals has been reduced by at least an amplitude threshold amount and the phase of each evoked response signal has been changed by at least a phase threshold amount.

[0069] For the purpose of explanation, Figure 8 An exemplary electrode lead insertion process is shown, in which electrode lead 600 is advanced into cochlea 602. Figure 8 A graph 702 also shows the amplitude 706 (e.g., amplitudes 706-1 to 706-4) of the induced response signal recorded by electrode 604-1 during the lead insertion process. Furthermore, Figure 8A graph 704 shows the phases 708 (e.g., phases 708-1 to 708-4) of the evoked response signals recorded by electrode 604-1 during the lead insertion process. In this example, the first, second, third, and fourth evoked response signals are generated in response to acoustic stimuli having stimulation frequencies of 2 kHz, 1 kHz, 500 Hz, and 250 Hz, respectively.

[0070] like Figure 8 As shown in Figure 702, electrode lead 600 has made contact with basement membrane 710 at position 802 along the length of basement membrane 710. Therefore, as shown in Figure 702, the amplitude 706 of each of the first, second, third, and fourth evoked response signals increases and reaches a peak due to the contact of electrode lead 600 with basement membrane 710 at position 802. Furthermore, as shown in Figure 704, the phase 708 of each of the first, second, third, and fourth evoked response signals also changes from a relatively high level to a relatively low level due to the contact of electrode lead 600 with basement membrane 710 at position 802.

[0071] like Figure 8 As shown, the reduction in amplitude 706 and the change in phase 708 of the first, second, third, and fourth evoked responses from high to low levels occur substantially at the same time (e.g., within a predetermined time period), and each occurs when the electrode lead 600 contacts the basement membrane 710 and changes the mechanical stiffness of the basement membrane 710. Therefore, the diagnostic system 300 can determine that the electrode lead 600 is in contact with a structure such as the basement membrane 710 by determining that the amplitude of each of the plurality of evoked response signals has decreased by at least an amplitude threshold amount and the phase of each evoked response signal has changed by at least a phase threshold amount within a predetermined time period. The predetermined time period, amplitude threshold amount, and / or phase threshold amount can each be set by the diagnostic system 300 to any suitable value, as described herein.

[0072] In some examples, the diagnostic system 300 may be configured to determine the contact location and / or amount of contact relative to the structure of the cochlea 602 based on the amplitude and phase of each evoked response signal. The contact location can be determined in any suitable manner. Furthermore, the amount of contact can also be determined in any suitable manner. For example, Figure 8 The amplitude 706 of each of the first, second, third, and fourth evoked response signals shown may indicate a first contact amount relative to the basement membrane 710 at position 802. A relatively larger amplitude 706 of each of the first, second, third, and fourth evoked response signals may indicate a second contact amount relative to the basement membrane 710 at position 802 that is relatively larger than the first contact amount. Alternatively, the amount of phase change may also indicate the contact amount relative to the basement membrane 710 at position 802. For example, Figure 8The phase change shown indicates that the electrode lead 600 contacts the basement membrane 710 with a first contact amount. The phase change may increase with greater contact and / or in response to the electrode lead 600 displacing the basement membrane 710.

[0073] In some examples, the insertion state of the electrode lead can be associated with the electrode lead passing through a cluster of specific types of cells (e.g., hair cells, neurons, etc.) within the cochlea. In such an example, the diagnostic system 300 can determine that the electrode lead passes through a cluster of specific types of cells (e.g., hair cells) when the amplitude of one or more evoked response signals included in a plurality of evoked response signals has decreased by at least an amplitude threshold amount and the phase of said one or more evoked response signals has not changed by at least a phase threshold amount. For example, the diagnostic system 300 can determine that the electrode lead passes through a cluster of hair cells when the amplitude of the second, third, and fourth evoked response signals has decreased by at least an amplitude threshold amount and the phase of the second, third, and fourth evoked response signals has not changed by at least a phase threshold amount.

[0074] In some alternative examples, when the amplitude of each evoked response signal included in a plurality of evoked response signals has been reduced by at least an amplitude threshold amount and the phase of each evoked response signal has not changed by at least a phase threshold amount, the diagnostic system 300 can determine that the electrode lead passes through a cluster of a specific type of cell (e.g., hair cells). For illustrative purposes, Figure 9 An exemplary electrode lead insertion process is shown, in which electrode lead 600 is advanced into cochlea 602. Figure 9 A graph 702 also shows the amplitude 706 (e.g., amplitudes 706-1 to 706-4) of the induced response signal recorded by electrode 604-1 during the lead insertion process. Furthermore, Figure 9 A graph 704 shows the phases 708 (e.g., phases 708-1 to 708-4) of the evoked response signals recorded by electrode 604-1 during the lead insertion process. In this example, the first, second, third, and fourth evoked response signals are generated in response to acoustic stimuli having stimulation frequencies of 2 kHz, 1 kHz, 500 Hz, and 250 Hz, respectively.

[0075] like Figure 9As shown, electrode lead 600 passes through clusters of hair cells 902 along the length of cochlea 602. Due to passing through clusters of hair cells 902, the amplitude 706 of each of the first, second, third, and fourth evoked response signals peaks and decreases at the insertion time associated with passing through clusters of hair cells 902. However, as shown in Figure 704, the phase 708 of each of the first, second, third, and fourth evoked response signals does not change by at least a phase threshold amount due to passing through clusters of hair cells 902. Therefore, when the amplitude of one or more evoked response signals included in the plurality of evoked response signals has decreased by at least an amplitude threshold amount and the phase of said one or more evoked response signals has not changed by at least a phase threshold amount within a predetermined time period, diagnostic system 300 can determine that electrode lead 600 passes through clusters of hair cells 902.

[0076] In some examples, the insertion state of the electrode lead may be associated with possible trauma to the recipient cochlear structure (e.g., translocation from the scala tympani to the scala vestibulae (i.e., due to puncture through the basilar membrane)). Such trauma can be caused by the electrode lead puncturing the basilar membrane of the cochlea, being unintentionally placed in the wrong canal of the cochlea, and / or by any other suitable means. In such examples, the diagnostic system 300 may determine that the electrode lead has caused trauma to the cochlea based on the determination that the amplitude of each of the multiple evoked response signals included has decreased by at least an amplitude threshold amount, and that the phase of the evoked response signal has changed by a phase threshold amount that is relatively larger than another phase threshold amount indicating that the electrode lead has only contacted the cochlear structure. In this respect, in some implementations, the diagnostic system 300 may use different phase threshold amounts to determine different insertion states of the electrode lead 600.

[0077] For the purpose of explanation, Figure 10 An exemplary electrode lead insertion process is shown, in which electrode lead 600 is advanced into cochlea 602. Figure 10 A graph 702 also shows the amplitude 706 (e.g., amplitudes 706-1 to 706-4) of the induced response signal recorded by electrode 604-1 during the lead insertion process. Furthermore, Figure 10 A graph 704 shows the phases 708 (e.g., phases 708-1 to 708-4) of the evoked response signals recorded by electrode 604-1 during the lead insertion process. In this example, the first, second, third, and fourth evoked response signals are generated in response to acoustic stimuli having stimulation frequencies of 2 kHz, 1 kHz, 500 Hz, and 250 Hz, respectively.

[0078] like Figure 10As shown, the electrode lead has contacted and punctured the basement membrane 710 at position 1002 along its length. Therefore, as shown in Figure 702, the amplitude 706 of each of the first, second, third, and fourth induced response signals increases relative to each other and reaches a peak, or decreases by at least an amplitude threshold amount, due to the electrode lead 600 puncturing the basement membrane 710 at position 1002. As shown in Figure 704, the phase 708 of each of the first, second, third, and fourth induced response signals changes from a relatively high level to a relatively low level due to the electrode lead 600 puncturing the basement membrane 710. Figure 10 The phase change shown is relatively Figure 8 The phase change shown is relatively larger. This is because the electrode lead 600 only contacts the basement membrane 710 (e.g., Figure 8 Compared to (as shown in the diagram), electrode lead 600 has a relatively higher phase change threshold associated with trauma to cochlea 602.

[0079] like Figure 10 As shown, the reduction of the first, second, third, and fourth evoked response signals 706 by at least an amplitude threshold amount and the change of each phase 708 from a high level to a low level occur substantially at the same time, and each occurs when the electrode 604-1 punctures the basilar membrane 710. Therefore, based on the diagnostic system 300's determination within a predetermined time period that the amplitude of each evoked response signal included in the plurality of evoked response signals has been reduced by at least an amplitude threshold amount and that the phase change of each evoked response signal has been a phase threshold amount that is relatively larger than another phase threshold amount indicating contact between the electrode lead and the cochlear structure, the diagnostic system 300 can determine that the electrode 604-1 has caused trauma to the cochlea 602. The phase threshold amount associated with trauma to the cochlea 602 can be set by the diagnostic system 300 to any suitable value, as described herein.

[0080] In some examples, a decrease in the amplitude of each evoked response (e.g., evoked response amplitude 706) relative to each other by a different amount may additionally or alternatively indicate trauma to the cochlea caused by the electrode leads. Any appropriate amount of difference in the decrease in the amplitude of the evoked response signal can indicate trauma to the cochlea.

[0081] In some examples, the diagnostic system 300 may be configured to provide notification of the insertion status when the electrode leads are inserted into the cochlea. Such notification can be provided in any suitable manner. For example, the diagnostic system 300 may be configured to provide audible, text, and / or graphical notifications configured to inform a user (e.g., a surgeon) of the insertion status. In some examples, the notification may include a graph of evoked response signals for display in one or more graphs displayed via a display device (e.g., display device 408) associated with the diagnostic system 300. For example, the diagnostic system 300 may instruct the display device to display the graph of evoked response signals substantially in real time as the insertion procedure is being performed, such that each of the multiple evoked response signals included in the plurality of evoked response signals is displayed such that, at any given time, many of the multiple evoked response signals included in the plurality of evoked response signals are simultaneously displayed by the display device. By displaying one or more graphs of evoked response signals recorded by the electrodes during the insertion procedure, the diagnostic system 300 can provide real-time feedback to the user (e.g., a surgeon) performing the insertion procedure. This feedback can be used by the user to ensure that the electrode lead 600 is properly positioned within the cochlea 602 and / or for any other purpose that may serve a particular implementation.

[0082] For the purpose of explanation, in Figure 10 During the exemplary insertion process shown, system 300 can be configured to provide a text notification in a graphical user interface on the display screen to indicate that the electrode lead 600 has punctured the basilar membrane 710. In response to seeing such a notification appear in the graphical user interface, the user can stop the insertion process and / or take other remedial actions (e.g., by pulling the electrode lead back out of the cochlea, changing the electrode insertion angle, etc.). Any other type of notification (e.g., audible or visible notification) may also be presented to the user additionally or alternatively, as may be applicable to a particular implementation.

[0083] In some examples, the diagnostic system 300 may instruct the display device to display a first graph representing the amplitude of the evoked response signal and a second graph representing the phase of the evoked response signal. For example, the diagnostic system 300 may instruct the display device to display, in any suitable manner, for example... Figure 10 In the diagram, chart 702 is displayed as the first chart and chart 704 is displayed as the second chart. In some examples, the diagnostic system 300 may instruct the display device to simultaneously display charts 702 and 704 in a single graphical user interface.

[0084] Alternatively, the single graphical user interface displaying figures 702 and 704 may also display, for example, [other related information]. Figure 8The diagram illustrates a graphical representation of a cochlea 602 and an electrode lead 600 being inserted into the cochlea 602 during the insertion process. In such an example, the graphical representation of the electrode lead 600 can be animated to facilitate the illustration of the electrode lead 600 being inserted into the cochlea 602 in real time. Furthermore, this graphical representation of the electrode lead 600 is animated to illustrate certain insertion states. For example, if the diagnostic system 300 determines that an insertion state has occurred involving contact between the electrode lead 600 and the structures of the cochlea 602, the graphical representation of the electrode lead can be drawn as contacting the wall of the cochlea 602.

[0085] In some alternative implementations, the diagnostic system 300 may instruct a display device to display the amplitude and phase of the evoked response signal for display in a single graph. For illustration, Figure 11 An alternative implementation is shown in which a single graph 1102 includes both amplitude 706 and phase 708 of first, second, third, and fourth induced response signals that can be generated in response to the insertion process of electrode lead 600 through the cluster of hairs 902. Graph 1102 can be provided for display to a user in any suitable graphical user interface to facilitate the user's implementation of the insertion process.

[0086] Figure 12 The figure illustrates an exemplary method 1200. Figure 12 The operations shown can be implemented by the diagnostic system 300 and / or any of its implementations. Although Figure 12 The figure illustrates exemplary operation according to one embodiment; however, other embodiments may omit, add, reorder, and / or modify these features. Figure 12 Any of the operations shown.

[0087] In operation 1202, the diagnostic system guides an acoustic stimulator to apply acoustic stimulation with multiple stimulation frequencies to the recipient of the cochlear implant during the insertion process, during which an electrode lead communicatively coupled to the cochlear implant is inserted into the recipient's cochlea. Operation 1202 can be implemented in any of the manner described herein.

[0088] In operation 1204, the diagnostic system guides the cochlear implant to record multiple evoked response signals using electrodes positioned on the electrode leads during the insertion process. Each of the multiple evoked response signals corresponds to a different stimulation frequency included in a plurality of stimulation frequencies and represents an evoked response occurring within the recipient in response to an acoustic stimulus applied to the recipient. Operation 1204 can be implemented in any of the manner described herein.

[0089] In operation 1206, the diagnostic system determines the insertion status of the electrode lead within the recipient's cochlea based on the amplitude and phase of each of one or more evoked response signals included in a plurality of evoked response signals. Operation 1206 may be implemented in any of the manner described herein.

[0090] In some examples, a non-transitory computer-readable medium for storing computer-readable instructions can be provided based on the principles described herein. These instructions, when executed by a processor of a computing device, can instruct the processor and / or the computing device to perform one or more operations, including one or more operations described herein. Such instructions can be stored and / or transmitted using any of a variety of known computer-readable media.

[0091] Non-transitory computer-readable media as referred to herein may include any non-transitory storage medium that contributes to providing data (e.g., instructions) that can be read and / or executed by a computing device (e.g., by a processor of the computing device). For example, non-transitory computer-readable media may include, but is not limited to, any combination of non-volatile storage media and / or volatile storage media. Exemplary non-volatile storage media include, but are not limited to, read-only memory, flash memory, solid-state drives, magnetic storage devices (e.g., hard disks, floppy disks, magnetic tapes, etc.), ferromagnetic random access memory (“RAM”), and optical discs (e.g., optical discs, digital video discs, Blu-ray discs, etc.). Exemplary volatile storage media include, but are not limited to, RAM (e.g., dynamic RAM).

[0092] Figure 13 The figure illustrates an exemplary computing device 1300, which may be specifically configured to implement one or more processes described herein. Figure 13 As shown, computing device 1400 may include a communication interface 1302, a processor 1304, a storage device 1306, and an input / output (“I / O”) module 1308 that are communicatively connected to each other via communication infrastructure 1310. Although the exemplary computing device 1300 is shown in… Figure 13 In the middle, however Figure 13 The components illustrated are not intended to be limiting. Additional or alternative components may be used in other embodiments. These will now be described in further detail. Figure 13 Components of the computing device 1300 shown.

[0093] Communication interface 1302 can be configured to communicate with one or more computing devices. Examples of communication interface 1302 include, but are not limited to, wired network interfaces (e.g., network interface cards), wireless network interfaces (e.g., wireless network interface cards), modems, audio / video connections, and any other suitable interfaces.

[0094] Processor 1304 generally represents any type or form of processing unit capable of processing data and / or interpreting, executing, and / or directing the execution of one or more of the instructions, procedures, and / or operations described herein. Processor 1304 may operate by executing computer-executable instructions 1312 (e.g., application programs, software, code, and / or other executable data instances) stored in storage device 1306.

[0095] Storage device 1306 may include one or more data storage media, devices, or configurations and may take the form of data storage media and / or devices of any type, form, and combination. For example, storage device 1306 may include, but is not limited to, any combination of non-volatile media and / or volatile media described herein. Electronic data, including the data described herein, may be temporarily and / or permanently stored in storage device 1306. For example, data representing computer-executable instructions 1312 configured to boot processor 1304 to perform any of the operations described herein may be stored within storage device 1306. In some examples, data may be arranged in one or more databases residing within storage device 1306.

[0096] I / O module 1308 may include one or more I / O modules configured to receive user input and provide user output. I / O module 1308 may include any hardware, firmware, software, or combinations thereof that support input and output functions. For example, I / O module 1308 may include hardware and / or software for capturing user input, including but not limited to a keyboard or keypad, a touch screen component (e.g., a touch screen display), a receiver (e.g., an RF or infrared receiver), a motion sensor, and / or one or more input buttons.

[0097] I / O module 1308 may include one or more means for presenting output to a user, including but not limited to a graphics engine, a display (e.g., a screen), one or more output drivers (e.g., display drivers), one or more audio speakers, and one or more audio drivers. In some embodiments, I / O module 1308 is configured to provide graphics data to the display for presentation to a user. The graphics data may represent one or more graphical user interfaces and / or any other graphical content that may serve a particular implementation.

[0098] In some examples, any of the systems, computing devices and / or other components described herein may be implemented by computing device 1300. For example, storage facility 302 may be implemented by storage device 1306, and processing facility 304 may be implemented by processor 1304.

[0099] Various exemplary embodiments have been described in the preceding description with reference to the accompanying drawings. However, it will be apparent that various modifications and variations can be made to the described embodiments without departing from the scope of the invention as set forth in the appended claims, and other embodiments may be implemented. For example, certain features of one embodiment described herein may be combined with or substitute for features of another embodiment described herein. Accordingly, the description and drawings should be viewed in an illustrative rather than restrictive sense.

Claims

1. A system for determining the insertion state of an electrode lead during electrode lead insertion, comprising: The memory stores instructions; and A processor, communicatively coupled to memory and configured to execute instructions to: An acoustic stimulation generator is directed to apply acoustic stimulation with multiple stimulation frequencies to the recipient of the cochlear implant during an insertion process in which an electrode lead communicatively coupled to the cochlear implant is inserted into the cochlea of ​​the recipient, wherein each of the multiple stimulation frequencies is applied to the recipient concurrently. The cochlear implant is guided to record a plurality of evoked response signals during the insertion process using an electrode disposed on an electrode lead, each of the plurality of evoked response signals corresponding to a different stimulation frequency included in a plurality of stimulation frequencies and representing an evoked response occurring in the recipient in response to an acoustic stimulus applied to the recipient; and The insertion status of the electrode leads in the recipient's cochlea is determined based on the amplitude and phase of each of one or more of the plurality of evoked response signals.

2. The system as claimed in claim 1, wherein, Determining the location of the electrode at a characteristic frequency within the cochlea based on at least one of the following The amplitude of any additional evoked response signal included in the plurality of evoked response signals is not reduced by at least an amplitude threshold amount; or The phase of the additional induced response signal did not change by at least the phase threshold amount.

3. The system as described in claim 1, wherein, The processor is further configured to execute instructions to: Within a predetermined time period, it is determined that the amplitude of one or more evoked response signals included in the plurality of evoked response signals has decreased by at least an amplitude threshold amount and the phase of the one or more evoked response signals has not changed by at least a phase threshold amount. The determination of the insertion state includes determining that the electrode passes through the hair cell tuft within the cochlea based on the determination that the amplitude of one or more evoked response signals included in the plurality of evoked response signals has decreased by at least an amplitude threshold amount and the phase of the one or more evoked response signals has not changed by at least a phase threshold amount.

4. The system as claimed in claim 1, wherein, The processor is further configured to execute instructions to: Within a predetermined time period, it is determined that the amplitude of at least two of the plurality of evoked response signals has decreased by at least an amplitude threshold amount and the phase of the at least two evoked response signals has changed by at least a phase threshold amount. The determination of the insertion state includes determining the structural contact between the electrode lead and the cochlea based on determining that the amplitude of at least two of the plurality of evoked response signals has decreased by at least an amplitude threshold amount and the phase of the at least two evoked response signals has changed by at least a phase threshold amount.

5. The system as described in claim 4, wherein, Determining the insertion state further includes: determining at least one of the contact position or contact amount relative to the cochlear structure based on the amplitude and phase of the at least two evoked response signals.

6. The system of claim 4, wherein, The structure of the cochlea is the basilar membrane of the cochlea.

7. The system as claimed in claim 1, wherein, The processor is further configured to execute instructions to: Within a predetermined time period, it is determined that the amplitude of each evoked response signal included in the plurality of evoked response signals has decreased by at least an amplitude threshold amount and the phase of each evoked response signal has changed by at least a phase threshold amount that is relatively larger than another phase threshold amount of the structure indicating that the electrode lead contacts the cochlea. The determination of the insertion state includes determining that the electrode lead has displaced the structure and caused trauma to the cochlea based on determining that the amplitude of each evoked response signal included in the plurality of evoked response signals has decreased by at least an amplitude threshold amount and the phase of each evoked response signal has changed by at least the phase threshold amount.

8. The system of claim 1, wherein, The processor is further configured to execute instructions to provide notification of the insertion status when the electrode leads are inserted into the recipient's cochlea.

9. The system as claimed in claim 1, wherein, The processor is further configured to execute instructions to: instruct the display device to display a graph of evoked response signals in real time while the insertion process is being performed, such that, by displaying the evoked response signals, at any given time, multiple evoked response signals included in the plurality of evoked response signals are simultaneously displayed by the display device.

10. The system of claim 9, wherein, The guidance display device for displaying a graph of the evoked response signal includes: guiding the display device to display the amplitude and phase of the evoked response signal for display in a single graph.

11. The system of claim 9, wherein, The guiding display device for displaying graphs of induced response signals includes the guiding display device for displaying: The first graph representing the amplitude of the evoked response signal; and The second chart represents the phase of the induced response signal.

12. The system of claim 1, wherein, The electrode is the farthest electrode disposed on the electrode lead.

13. A computer program product comprising instructions that, when executed by a processor, cause the processor to: An acoustic stimulator is guided to apply acoustic stimuli with multiple stimulation frequencies to the recipient of the cochlear implant during the insertion process, in which the electrode leads, which are communicatively coupled to the cochlear implant, are inserted into the recipient's cochlea. Each of the plurality of stimulation frequencies is applied to the receptor concurrently; The cochlear implant is guided to record a plurality of evoked response signals during the insertion process using an electrode disposed on an electrode lead, each of the plurality of evoked response signals corresponding to a different stimulation frequency included in the plurality of stimulation frequencies and representing an evoked response occurring in the recipient in response to an acoustic stimulus applied to the recipient; and The insertion status of the electrode leads in the recipient's cochlea is determined based on the amplitude and phase of each of one or more of the plurality of evoked response signals.

14. The computer program product of claim 13, further comprising instructions that, when executed by a processor, cause the processor to provide notification of the insertion status when the cochlear implant is inserted into the cochlea of ​​the recipient.

15. The computer program product of claim 13, further comprising instructions that, when executed by the processor, cause the processor to instruct the display device to display a graph of evoked response signals in real time during the insertion process, such that, by displaying the evoked response signals, at any given time, a plurality of evoked response signals included in the plurality of evoked response signals are simultaneously displayed by the display device.

16. The computer program product of claim 15, wherein, The guidance display device for displaying a graph of the evoked response signal includes: guiding the display device to display the amplitude and phase of the evoked response signal for display in a single graph.

17. The computer program product of claim 15, wherein, The guiding display device for displaying graphs of induced response signals includes the guiding display device for displaying: The first graph representing the amplitude of the evoked response signal; and The second chart represents the phase of the induced response signal.

18. A non-transitory computer-readable storage medium storing instructions that, when executed, direct a processor to: An acoustic stimulator is guided to apply acoustic stimuli with multiple stimulation frequencies to the recipient of the cochlear implant during the insertion process, in which the electrode leads, which are communicatively coupled to the cochlear implant, are inserted into the recipient's cochlea. Each of the plurality of stimulation frequencies is applied to the receptor concurrently; The cochlear implant is guided to record a plurality of evoked response signals during the insertion process using an electrode disposed on an electrode lead, each of the plurality of evoked response signals corresponding to a different stimulation frequency included in the plurality of stimulation frequencies and representing an evoked response occurring in the recipient in response to an acoustic stimulus applied to the recipient; and The insertion status of the electrode leads in the recipient's cochlea is determined based on the amplitude and phase of each of one or more of the plurality of evoked response signals.

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