Patent ID: 12208265

DETAILED DESCRIPTION

Systems and methods for detecting scalar translocation of an electrode lead within a cochlea of a cochlear implant patient are described herein. Detecting a scalar translocation of an electrode lead may assist in detecting trauma and/or identifying the position and/or insertion path of an electrode lead with respect to a cochlea that the electrode lead is inserted into (e.g., in a surgical insertion procedure). As used herein, a “scalar translocation” of an electrode lead refers to a translocation (i.e., a movement from one location to another) of an electrode lead (e.g., a distal end of the electrode lead, in particular) from one scala of the cochlea of a patient (e.g., the scala tympani) to another scala of the cochlea of the patient (e.g., the scala vestibuli). For example, during an insertion procedure whereby an electrode lead is inserted into a cochlea, the electrode lead may travel through the round window into the scala tympani of the cochlea but, instead of continuing to travel through the scala tympani, may inadvertently puncture the basilar membrane and/or other anatomy separating the scala tympani from the scala vestibuli to enter the scala vestibuli. Because such a scalar translocation may damage the basilar membrane (e.g., including hair cells disposed on the basilar membrane and associated with residual hearing of the patient), the translocation of the electrode lead may cause trauma to the cochlea. As such, it may be desirable to detect scalar translocation in real time during the insertion procedure (e.g., so that the scalar translocation may be corrected if possible) and/or after the fact (e.g., so that the scalar translocation may be associated with data being studied to help reduce trauma and improve outcomes in subsequent insertion procedures, or for other suitable purposes as will be described below).

To this end, as will be described in more detail below, an exemplary system for detecting scalar translocation of an electrode lead within a cochlea of a cochlear implant patient may be implemented by at least one physical computing device (e.g., by a computing system coupled to a cochlear implant system, by a sound processor included within a cochlear implant system, by a combination of a computing system and a sound processor included within a cochlear implant system, etc.). The system (e.g., the at least one physical computing device) may detect a first evoked response that occurs in response to acoustic stimulation applied to the cochlear implant patient. For example, the system may detect the first evoked response by way of an electrode configuration including at least one electrode disposed on the electrode lead while the electrode configuration is positioned at a first location along an insertion path of the electrode lead into the cochlea of the patient. The system may further detect a second evoked response that occurs in response to additional acoustic stimulation applied to the cochlear implant patient. For instance, the system may detect the second evoked response by way of the electrode configuration while the electrode configuration is positioned at a second location along the insertion path of the electrode lead into the cochlea (e.g., a second location deeper into the cochlea or nearer to the apex of the cochlea).

Based on the first and second evoked responses, the system may determine at least one of an amplitude change between the first and second evoked responses and a phase change between the first and second evoked responses. Accordingly, based on the amplitude change and/or the phase change, the system may determine whether a scalar translocation of the electrode lead from one scala of the cochlea (e.g., the scala tympani) to another scala of the cochlea (e.g., the scala vestibuli) has occurred.

In certain examples, as mentioned above, disclosed systems and methods may be employed to detect scalar translocation of an electrode lead in real time during an insertion procedure of the electrode lead into a cochlea of a cochlear implant patient. For example, at least one physical computing device included within such a system may, in real time during the insertion procedure, track trauma occurring to the cochlea during the insertion procedure by performing a sequence of scalar translocation determination operations. Specifically, each scalar translocation determination operation may include (e.g., may be implemented by performing) detecting a first evoked response that occurs in response to acoustic stimulation applied to the cochlear implant patient. For instance, the detecting of the first evoked response may be performed by way of an electrode nearest a distal end of the electrode lead at a first time during the insertion procedure while the electrode is positioned at a first location along an insertion path of the electrode lead into the cochlea. Each scalar translocation determination operation may further include detecting a second evoked response that occurs in response to additional acoustic stimulation applied to the cochlear implant patient. As with the detecting of the first evoked response, the detecting of the second evoked response may be performed by way of the same electrode (i.e., the electrode nearest the distal end of the electrode lead) at a second time during the insertion procedure while the electrode is positioned at a second location along the insertion path of the electrode lead into the cochlea.

Each scalar translocation determination operation may further include determining at least one of an amplitude change between the first and second evoked responses and a phase change between the first and second evoked responses, determining (e.g., based on the amplitude change and/or the phase change) whether a scalar translocation of the electrode lead from one scala of the cochlea to another scala of the cochlea has occurred, and determining (e.g., if the determination of whether the scalar translocation of the electrode lead has occurred indicates that the scalar translocation of the electrode lead has occurred) that trauma associated with the scalar translocation has occurred to the cochlea.

Along with performing the sequence of scalar translocation determination operations, the system may further provide a user interface for use by a user associated with the system (e.g., a surgeon or a member of a surgical team performing the insertion procedure), and may provide (e.g., to the user by way of the user interface) information representative of the tracked trauma occurring to the cochlea during the insertion procedure. For instance, the user interface may notify the user when a scalar translocation of the electrode lead has been detected, or may indicate to the user that no scalar translocation of the electrode lead has yet been detected (i.e., that the insertion procedure is so far proceeding without incident).

Disclosed systems and methods for detecting scalar translocation of an electrode lead within a cochlea of a cochlear implant patient may provide various benefits to cochlear implant patients, as well as to surgeons and others involved with insertion procedures. For example, by providing real time information about whether a scalar translocation of the electrode lead or other trauma is occurring during an insertion procedure, disclosed systems and methods may provide a surgeon performing the insertion procedure more information and perspective into the intricate insertion procedure, thereby allowing for a translocated electrode lead to be corrected (e.g., withdrawn and reinserted without scalar translocation) or for trauma to otherwise be mitigated to facilitate a successful outcome of the insertion procedure.

Along with providing perspective into the insertion procedure (e.g., informing surgeons and surgical team members which scala(s) an electrode lead being inserted is currently located in), disclosed systems and methods may further provide data representative of whether a scalar translocation of the electrode lead has occurred, which scala the electrode lead is currently located in, and so forth, to computer systems used to facilitate the insertion procedure. This may allow the computer systems to provide feedback or warnings (e.g., by way of user interfaces, lights, sounds, etc.) that may help the surgeon and other people involved in performing the insertion procedure to proceed with appropriate care at various stages of the procedure. Moreover, in situations where variables such as procedure time, electrode lead location (e.g., current insertion depth), and the like are being tracked along with the cochlear trauma, computer systems may log trauma events to correlate with these other variables to be used in subsequent procedures for other cochlear implant patients (e.g., to warn surgeons to take particular care at particular times or insertion depths, to perform particular actions when an electrode lead is coming up on a depth where a scalar translocation of the electrode lead has previously occurred, etc.).

Even after an insertion procedure is complete, disclosed systems and methods for detecting scalar translocation of electrode leads may be useful for providing insight into a final resting location at which the electrode lead has been inserted. As will be described below, this may be done by detecting evoked responses at two different electrodes located at different locations along the insertion path traveled by the electrode lead at arbitrary times (e.g., at the same time) while the electrode lead is stationary, rather than by the same electrode (e.g., the electrode nearest the distal end of the electrode lead) as the electrode moves from one location at one time to another location at a later time. For example, detecting a scalar translocation of a stationary electrode lead after the insertion procedure may provide useful data for studying effects of scalar translocation and other cochlear trauma on ultimate hearing outcomes such as residual hearing changes over time. Moreover, by using different electrodes (e.g., electrodes X and Y) along the electrode lead to detect evoked responses, an approximate location of a scalar translocation (e.g., a location such as between electrode X and electrode Y on the fully inserted electrode lead) may be determined, providing additional useful data for the patient and for improving insertion procedures to be performed on additional patients in the future.

Additionally, regardless of whether disclosed system and methods for detecting scalar translocation of an electrode lead are performed in real time during an insertion procedure or after the fact when the electrode lead is stationary, the detecting of scalar translocation without use of expensive, inconvenient, or risky imaging technology (e.g., x-ray technology, fluoroscopic technology, CT scanning technology, etc.) may be beneficial. For example, by detecting the scalar translocation of the electrode lead while avoiding these other technologies, patients may be less exposed to various risks, inconveniences, costs, and/or other undesirable aspects associated with such technology.

Various embodiments will now be described in more detail with reference to the figures. The disclosed systems and methods may provide one or more of the benefits mentioned above and/or various additional and/or alternative benefits that will be made apparent herein.

FIG.1illustrates an exemplary cochlear implant system100. As shown, cochlear implant system100may include a microphone102, a sound processor104, a headpiece106having a coil disposed therein, a cochlear implant108, and an electrode lead110. Electrode lead110may include an array of electrodes112disposed on a distal portion of electrode lead110and that are configured to be inserted into the cochlea to stimulate the cochlea after the distal portion of electrode lead110is inserted into the cochlea. It will be understood that one or more other electrodes (e.g., including a ground electrode, not explicitly shown) may also be disposed on other parts of electrode lead110(e.g., on a proximal portion of electrode lead110) to, for example, provide a current return path for stimulation current generated by electrodes112and to remain external to the cochlea after electrode lead110is inserted into the cochlea. As shown, electrode lead110may be pre-curved so as to properly fit within the spiral shape of the cochlea. Additional or alternative components may be included within cochlear implant system100as may serve a particular implementation.

As shown, cochlear implant system100may include various components configured to be located external to a patient including, but not limited to, microphone102, sound processor104, and headpiece106. Cochlear implant system100may further include various components configured to be implanted within the patient including, but not limited to, cochlear implant108and electrode lead110.

Microphone102may be configured to detect audio signals presented to the user. Microphone102may be implemented in any suitable manner. For example, microphone102may include a microphone that is configured to be placed within the concha of the ear near the entrance to the ear canal, such as a T-MIC™ microphone from Advanced Bionics. Such a microphone may be held within the concha of the ear near the entrance of the ear canal by a boom or stalk that is attached to an ear hook configured to be selectively attached to sound processor104. Additionally or alternatively, microphone102may be implemented by one or more microphones disposed within headpiece106, one or more microphones disposed within sound processor104, one or more beam-forming microphones, and/or any other suitable microphone as may serve a particular implementation.

Sound processor104(i.e., one or more components included within sound processor104) may be configured to direct cochlear implant108to generate and apply electrical stimulation (also referred to herein as “stimulation current”) representative of one or more audio signals (e.g., one or more audio signals detected by microphone102, input by way of an auxiliary audio input port, input by way of a CPI device, etc.) to one or more stimulation sites associated with an auditory pathway (e.g., the auditory nerve) of the patient. Exemplary stimulation sites include, but are not limited to, one or more locations within the cochlea, the cochlear nucleus, the inferior colliculus, and/or any other nuclei in the auditory pathway. To this end, sound processor104may process the one or more audio signals in accordance with a selected sound processing strategy or program to generate appropriate stimulation parameters for controlling cochlear implant108. Sound processor104may be housed within any suitable housing (e.g., a behind-the-ear (“BTE”) unit, a body worn device, headpiece106, and/or any other sound processing unit as may serve a particular implementation).

In some examples, sound processor104may wirelessly transmit stimulation parameters (e.g., in the form of data words included in a forward telemetry sequence) and/or power signals to cochlear implant108by way of a wireless communication link114between headpiece106and cochlear implant108(e.g., a wireless link between a coil disposed within headpiece106and a coil physically coupled to cochlear implant108). It will be understood that communication link114may include a bi-directional communication link and/or one or more dedicated uni-directional communication links.

Headpiece106may be communicatively coupled to sound processor104and may include an external antenna (e.g., a coil and/or one or more wireless communication components) configured to facilitate selective wireless coupling of sound processor104to cochlear implant108. Headpiece106may additionally or alternatively be used to selectively and wirelessly couple any other external device to cochlear implant108. To this end, headpiece106may be configured to be affixed to the patient's head and positioned such that the external antenna housed within headpiece106is communicatively coupled to a corresponding implantable antenna (which may also be implemented by a coil and/or one or more wireless communication components) included within or otherwise associated with cochlear implant108. In this manner, stimulation parameters and/or power signals may be wirelessly transmitted between sound processor104and cochlear implant108via a communication link114(which may include a bi-directional communication link and/or one or more dedicated uni-directional communication links as may serve a particular implementation).

Cochlear implant108may include any type of implantable stimulator that may be used in association with the systems and methods described herein. For example, cochlear implant108may be implemented by an implantable cochlear stimulator. In some alternative implementations, cochlear implant108may include a brainstem implant and/or any other type of cochlear implant that may be implanted within a patient and configured to apply stimulation to one or more stimulation sites located along an auditory pathway of a patient.

In some examples, cochlear implant108may be configured to generate electrical stimulation representative of an audio signal processed by sound processor104(e.g., an audio signal detected by microphone102) in accordance with one or more stimulation parameters transmitted thereto by sound processor104. Cochlear implant108may be further configured to apply the electrical stimulation to one or more stimulation sites (e.g., one or more intracochlear regions) within the patient via electrodes112disposed along electrode lead110. In some examples, cochlear implant108may include a plurality of independent current sources each associated with a channel defined by one or more of electrodes112. In this manner, different stimulation current levels may be applied to multiple stimulation sites simultaneously by way of multiple electrodes112.

FIG.2illustrates a schematic structure of the human cochlea200into which electrode lead110may be inserted. As shown inFIG.2, cochlea200is in the shape of a spiral beginning at a base202and ending at an apex204. Within cochlea200resides auditory nerve tissue206, which is denoted by Xs inFIG.2. The auditory nerve tissue206is organized within the cochlea200in a tonotopic manner. Relatively low frequencies are encoded at or near the apex204of the cochlea200(referred to as an “apical region”) while relatively high frequencies are encoded at or near the base202(referred to as a “basal region”). Hence, electrical stimulation applied by way of electrodes disposed within the apical region (i.e., “apical electrodes”) may result in the patient perceiving relatively low frequencies and electrical stimulation applied by way of electrodes disposed within the basal region (i.e., “basal electrodes”) may result in the patient perceiving relatively high frequencies. The delineation between the apical and basal electrodes on a particular electrode lead may vary depending on the insertion depth of the electrode lead, the anatomy of the patient's cochlea, and/or any other factor as may serve a particular implementation.

FIG.3illustrates an exemplary implementation of cochlear implant system100in which cochlear implant system100is implemented as an electro-acoustic stimulation (“EAS”) system300. EAS system300may be configured to operate similarly to cochlear implant system100, except that EAS system300may be further configured to provide acoustic stimulation to the patient (e.g., to acoustically stimulate residual hearing that the patient may retain along with electrically stimulating the patient as described above).

As shown, EAS system300may include, along with the same components described above with respect to cochlear implant system100, a loudspeaker302. Loudspeaker302may be in communication with an ear of the patient (e.g., located at an entrance or within the ear canal of the patient). In this configuration, sound processor104(which, in EAS system300, may be referred to as an “EAS sound processor”) may be configured to direct loudspeaker302to apply acoustic stimulation representative of audio content to one or more stimulation sites within the patient (e.g., within cochlea200, described above in relation toFIG.2). For example, loudspeaker302may generate the acoustic stimulation used to evoke the evoked responses that may be used to detect the scalar translocation of electrode leads, as described above.

Specifically, for example, a cochlear implant system associated with a particular scalar translocation detection system may be implemented as an EAS system (e.g., EAS system300) communicatively coupled with the scalar translocation detection system. The EAS system may include a sound processor (e.g., sound processor104) and a loudspeaker (e.g., loudspeaker302) communicatively coupled to one another. In accordance with the scalar translocation detection operations described above, the scalar translocation detection system may thus direct the sound processor to direct the loudspeaker to apply the acoustic stimulation for the detection of the first evoked response, and direct the sound processor to direct the loudspeaker to apply the additional acoustic stimulation for the detection of the second evoked response. In some examples, a frequency of the acoustic stimulation and a frequency of the additional acoustic stimulation may be substantially the same. For example, the scalar translocation detection system may direct sound processor104to direct loudspeaker302to produce a tone at substantially the same frequency for both the acoustic stimulation and the additional acoustic stimulation. Or, as another example, the scalar translocation detection system may direct sound processor104to direct loudspeaker302to produce a single tone that acts as the acoustic stimulation and the additional acoustic stimulation for evoked responses that are detected simultaneously or closely in time to one another.

In some examples, at least one computing device (e.g., computing devices included within or implementing a scalar translocation detection system, a programming system, etc.) that is separate from (i.e., not included within) cochlear implant system100may be communicatively coupled to sound processor104for various purposes. For instance, a computing device may be employed to monitor cochlear trauma (e.g., scalar translocation of the electrode lead) during or after an insertion procedure, to otherwise facilitate proper insertion of electrode lead110into the cochlea of a patient (e.g., by tracking the insertion depth of the electrode lead or the like), to perform one or more programming or fitting operations with respect to cochlear implant system100(e.g., in a clinical setting after the electrode lead has been inserted), and/or for other suitable purposes as may serve a particular implementation. For example, during the insertion procedure, the at least one physical computing device may direct cochlear implant system100to perform operations (e.g., generating acoustic stimulation, detecting evoked responses in response to the acoustic stimulation, etc.) for detecting scalar translocation of the electrode lead within the cochlea of the patient. Subsequent to the insertion procedure, the at least one physical computing device may further be used to present audio clips to the patient by way of cochlear implant system100in order to facilitate evaluation of how well cochlear implant system100is performing for the patient. In other examples, any of these operations may be performed by components of cochlear implant system100(e.g., by sound processor104) without interaction with an external computing device.

To illustrate,FIG.4shows an exemplary configuration400in which a computing device402(e.g., a scalar translocation detection system, programming system, or the like) is communicatively coupled (e.g., by way of a wired or wireless communication channel) to sound processor104. Computing device402may be implemented by any suitable combination of physical computing and communication devices including, but not limited to, a fitting station or device, a programming device, a personal computer, a laptop computer, a handheld device, a mobile device (e.g., a mobile phone), a clinician's programming interface (“CPI”) device, and/or any other suitable component as may serve a particular implementation.

In some examples, computing device402may provide one or more user interfaces with which a user may interact. For example, a user interface may provide text, graphics, sounds, etc., to facilitate a successful insertion procedure of electrode lead110(e.g., by detecting a scalar translocation of the electrode lead) or effective programming of sound processor104as may serve a particular implementation. In some implementations, the user interface provided by computing device402may include a graphical user interface (“GUI”) that allows a user (e.g., a surgeon, a person assisting the surgeon during an insertion procedure, a clinician, etc.) to direct computing device402to perform operations for detecting a scalar translocation of the electrode lead within the cochlea. After performing the detection of the scalar translocation (i.e., after determining whether or not a scalar translocation of the electrode lead has occurred), the GUI may provide information representative of the determination by way of visual or audible feedback as may serve a particular implementation (e.g., a beep or red light if a scalar translocation of the electrode lead has occurred, silence or a green light if a scalar translocation of the electrode lead has not occurred, etc.).

As illustrated inFIG.4, in certain examples, computing device402may be communicatively coupled to a loudspeaker404. As such, computing device402may use loudspeaker404to generate acoustic stimulation for evoking the evoked responses for non-EAS cochlear implant systems such as cochlear implant system100(i.e., systems that, unlike EAS system300, do not include a dedicated loudspeaker for applying acoustic stimulation to the patient). Specifically, in reference to the scalar translocation detection operations described above, computing device402may direct loudspeaker404to apply the acoustic stimulation for the detection of the first evoked response, and direct loudspeaker404to apply the additional acoustic stimulation for the detection of the second evoked response. Similar to EAS system300and loudspeaker302described above, in some examples, a frequency of the acoustic stimulation and a frequency of the additional acoustic stimulation may be substantially the same. For example, computing device402may direct loudspeaker404to produce a tone at substantially the same frequency for both the acoustic stimulation and the additional acoustic stimulation. Or, as another example, computing device404may direct loudspeaker404to produce a single tone that acts as the acoustic stimulation and the additional acoustic stimulation for evoked responses that are detected simultaneously or closely in time to one another.

WhileFIG.4illustrates computing device402communicatively coupled with a cochlear implant system that is not an EAS system (e.g., a cochlear implant system similar to cochlear implant system100), it will be understood that, in certain examples, computing device402or another computing device similarly implementing a scalar translocation detection system may instead be communicatively coupled with an EAS system such as EAS system300. In such examples, it may not be necessary for computing system402to be communicatively coupled to loudspeaker404since a loudspeaker included in the EAS system can be used to apply acoustic stimulation to the patient instead (as described above).

FIG.5illustrates an exemplary configuration500in which computing device402is implemented by a personal computer502and a CPI device504. As shown, personal computer502may be selectively and communicatively coupled to CPI device504by way of a cable506. Likewise, CPI device504may be selectively and communicatively coupled to sound processor104by way of a cable508. Cables506and508may each include any suitable type of cable that facilitates transmission of digital data between personal computer502and sound processor104. For example, cable506may include a universal serial bus (“USB”) cable and cable508may include any type of cable configured to connect to a programming port included in sound processor104.

FIG.6illustrates a block diagram of exemplary components of a scalar translocation detection system600(“system600”). System600may be configured to perform any of the operations described herein for detecting scalar translocation of an electrode lead within a cochlea of a cochlear implant patient. To this end, as shown, system600may include an evoked response detection facility602, a processing facility604, and a storage facility606, which may be selectively and communicatively coupled to one another. It will be recognized that although facilities602through606are shown to be separate facilities inFIG.6, facilities602through606may be combined into fewer facilities, such as into a single facility, or divided into more facilities as may serve a particular implementation. In some examples, system600may include, implement, or be implemented by a computing device such as computing device402, described above. Each of facilities602through606will now be described in more detail.

Evoked response detection facility602may include or be implemented by one or more physical computing devices (e.g., including hardware and/or software such as processors, memories, communication interfaces, instructions stored in memory for execution by the processors, etc.) such as computing device402, computing components included in sound processor104, and/or other suitable computing devices that perform various operations associated with detecting evoked responses that occur in response to acoustic stimulation being applied to a cochlear implant patient. For example, evoked response detection facility602may generate acoustic stimulation to be applied to the patient or direct a loudspeaker to generate and apply such acoustic stimulation (e.g., directly directing loudspeaker402to generate the acoustic stimulation as described in relation toFIG.4, indirectly directing loudspeaker302to generate the acoustic stimulation by way of sound processor104as described in relation toFIG.3, etc.). The acoustic stimulation may be applied to the patient when an electrode configuration (e.g., a single electrode configuration including the electrode nearest the distal end of an electrode lead, a multiple electrode configuration including at least two different electrodes along the electrode lead, etc.) is positioned at a particular location along an insertion path of the electrode lead into a cochlea of the patient.

As such, the acoustic stimulation may cause an evoked response to occur (e.g., to be involuntarily generated by the patient) that may be detected by the electrode configuration at the particular location. The evoked response may be any type of evoked response as may serve a particular implementation. For example, as used herein, an “evoked response” may refer to an electrocochleographic (“ECoG”) potential, an auditory nerve response, a brainstem response, a compound action potential, and/or any other type of neural or physiological response that may occur within a patient in response to application of acoustic stimulation to the patient. In some examples, evoked responses may originate from neural tissues, hair cell to neural synapses, inner or outer hair cells, or other sources.

Accordingly, evoked response detection facility602may detect, by way of the electrode configuration while the electrode configuration is positioned at a first location along the insertion path of the electrode lead into the cochlea, a first evoked response that occurs in response to the acoustic stimulation applied to the patient. Evoked response detection facility602may further detect, by way of the electrode configuration while the electrode configuration is positioned at a second location along the insertion path, a second evoked response that occurs in response to additional acoustic stimulation applied to the patient. For instance, evoked response detection facility602may detect the first evoked response by detecting a first ECoG potential occurring in response to the acoustic stimulation, and detect the second evoked response by detecting a second ECoG potential occurring in response to the additional acoustic stimulation. In some examples, the first and second ECoG potentials may be cochlear microphonic potentials. In other examples, other suitable ECoG potentials such as action potentials, summating potentials, or the like may be used in addition to or in place of the cochlear microphonic potentials.

Processing facility604may include or be implemented by one or more physical computing devices such as the same computing devices or similar (but separate) computing devices described above in relation to evoked response detection facility602. Based on evoked responses detected by evoked response detection facility602(e.g., the first and second evoked responses described above), processing facility604may be configured to determine at least one of an amplitude change between the first and second evoked response and a phase change between the first and second evoked responses. Moreover, based on the determined amplitude change and/or phase change, processing facility604may determine whether a scalar translocation of the electrode lead from one scala of the cochlea (e.g., the scala tympani) to another scala of the cochlea (e.g., the scala vestibuli) has occurred. Processing facility604may perform these determinations in any suitable way, such as will be described in more detail below.

In some examples, facilities602and604may perform some or all of the operations described above (e.g., the detections of the first and second evoked responses, the determination of the amplitude change and/or the phase change, the determination of whether the scalar translocation of the electrode lead has occurred, etc.) in real time during an insertion procedure of the electrode lead into the cochlea along the insertion path (e.g., while the surgical insertion procedure is ongoing). As used herein, an operation is considered to be performed in “real time” when the operation is performed immediately and without undue delay (e.g., in real time or near real time). Accordingly, operations may be said to be performed in real time and users of system600(e.g., surgeons, surgical team members, etc.) may be considered to receive real time information during the insertion procedure even if the information is provided after a small delay (e.g., up to a few seconds).

In these examples where system600is used to perform operations in real time during the insertion procedure, facilities602and604may be used to continuously and dynamically track trauma as it occurs during the insertion procedure. Specifically, for instance, if the determination by processing facility604as to whether the scalar translocation of the electrode lead has occurred indicates that the scalar translocation of the electrode lead has occurred, processing facility604may determine that trauma associated with the scalar translocation has occurred to the cochlea. As such, system600may track trauma occurring to the cochlea during the insertion procedure by performing a sequence of scalar translocation determination operations each including a respective performance of the detections of the first and second evoked responses (e.g., by evoked response detection facility602), the determination of the amplitude change and/or the phase change (e.g., by processing facility604), and the determination of whether the scalar translocation of the electrode lead has occurred (e.g., also by processing facility604).

As mentioned above, system600(e.g., processing facility604or another facility not explicitly illustrated inFIG.6) may facilitate use of the information determined by system600by providing a user interface for use by a user associated with system600(e.g., using system600, receiving information from system600), and by providing information representative of the determination of whether the scalar translocation of the electrode lead has occurred to the user by way of the user interface. This information may be provided in any of the ways described herein, such as by textual, graphical, color-based, audible, or other suitable means.

Storage facility606may maintain management data608and/or any other data received, generated, managed, maintained, used, and/or transmitted by facilities602and604in a particular implementation. Management data608may include data representative of evoked response measurements that have been made, or data used to make such measurements (e.g., data representative of acoustic stimulation levels, data representative of timing information for detecting voltages in response to generated acoustic stimulation, etc.), or the like. Additionally, management data608may include data representative of scalar translocations of electrode leads and/or other trauma that has been detected or data to facilitate such detections. Storage facility606may further include any other data as may serve a particular implementation of system600to facilitate performing one or more of the operations described herein.

In order to illustrate the context in which an insertion procedure is performed and how a scalar translocation of an electrode lead may occur,FIG.7shows exemplary aspects of an electrode lead and of patient anatomy as an exemplary insertion procedure is performed. Specifically, as shown, an insertion procedure702is illustrated in which a distal portion of an electrode lead704is inserted into a cochlea706of a patient along an insertion path708(i.e., which is illustrated in part by a dashed curve but will be understood to including the entire path taken by electrode lead704within cochlea706). It will be understood that, while only a distal portion of electrode lead704is illustrated inFIG.7, a proximal portion of the electrode lead not explicitly shown may be coupled to a cochlear implant (also not shown) that may direct current into electrode lead704, receive and pass on data detected by electrode lead704(e.g., evoked response data or the like), and so forth.

As shown, electrode lead704may include various electrodes including a leading electrode710nearest a distal end of electrode lead704and several additional electrodes712disposed along the length of electrode lead704. Unless the context dictates otherwise, it will be understood that electrodes712, when referred to generally herein, may include all the electrodes disposed on electrode lead704including electrode710and/or electrodes not explicitly shown inFIG.7.

As illustrated inFIG.7, insertion procedure702may involve inserting electrode lead704through an entry point714(e.g., within a round window or cochleostomy of cochlea706, or another suitable location) and into a scala tympani716of cochlea706. Scala tympani716is a chamber of cochlea706that is separated by a basilar membrane718(e.g., as well as other membranes and anatomical structures not explicitly shown or labeled inFIG.7) from a scala vestibuli720of cochlea706(i.e., a separate chamber of the cochlea). As such, vibrations introduced at an oval window722of cochlea706may vibrate through fluid included in scala vestibuli720toward the apex of cochlea706and back toward the base of cochlea706through fluid included in scala tympani716. In other words, sound vibrations traveling on either side of basilar membrane718may be moving in opposite directions and, as such, may be out of phase with one another. As the vibrations travel through fluid in scala tympani716, the vibrations may be detected and encoded by hair cells along basilar membrane718(if undamaged hair cells are present in the particular patient). Additionally or alternatively, electrodes712disposed throughout scala tympani716may generate electrical stimulation to stand in for the function of damaged hair cells. Regardless, nerves associated with different depths (i.e., frequency regions) along cochlea706may send signals to the brain to effect a hearing sensation, as described above in relation toFIG.2.

FIG.7illustrates electrode lead704within cochlea706at a particular moment during insertion procedure702. Specifically, at the moment depicted inFIG.7, electrode lead704has translocated from scala tympani716, through basilar membrane718, and into scala vestibuli720at a translocation site724. This scalar translocation of electrode lead704may have occurred for any of a variety of reasons during insertion procedure702, but is most likely an undesirable occurrence because, as shown, the distal end of electrode lead704(i.e., at leading electrode710) has physically penetrated basilar membrane718, thereby potentially causing trauma to basilar membrane718and/or any of various other parts of cochlea706associated with basilar membrane718(e.g., previously functional hair cells along basilar membrane718, other membranes or nerves associated with basilar membrane718, etc.).

To mitigate trauma caused by the scalar translocation of electrode lead704and/or to facilitate avoidance of similar scalar translocations in future insertion procedures, a scalar translocation detection system such as system600may detect the scalar translocation in any of the ways described herein. For instance, system600may detect first and second evoked responses by way of an electrode configuration that includes leading electrode710nearest the distal end of electrode lead704. The detection of the first evoked response may thus be performed by way of electrode710at a first time during insertion procedure702when electrode710is positioned at a first location along insertion path708(e.g., a location within scala tympani716prior to the moment during the insertion procedure when the scalar translocation of electrode lead704occurs). Thereafter, the detection of the second evoked response may be performed by way of electrode710at a second time during insertion procedure702when electrode710is positioned at a second location along insertion path708(e.g., the location of electrode710within scala vestibuli720at the moment depicted inFIG.7after the scalar translocation of electrode lead704has occurred).

Alternatively, system600may, in certain examples, detect first and second evoked responses by way of an electrode configuration that includes a first electrode on electrode lead704and a second electrode on electrode lead704, rather than using the same electrode at two different times as described above. For example, if insertion procedure702were to be temporarily suspended or already completed while electrode lead704is arranged at the location shown inFIG.7, system600may detect the scalar translocation of electrode lead704by way of a multiple-electrode electrode configuration while electrode lead704remains stationary. Specifically, system600may perform the detection of the first evoked response by way of leading electrode710(i.e., which, as shown, is located within scala vestibuli720) and perform the detection of the second evoked response by way of another electrode712included on electrode lead704such as the electrode712nearest to electrode710(i.e., the electrode that, as shown, is located mostly within scala tympani716but is nearly breaching basilar membrane718).

Both evoked responses may be detected simultaneously or at different times as long as electrode lead704is disposed, with respect to insertion path708, such that the distal-most electrode (i.e., electrode710) is positioned at a first location along insertion path708and the other electrode (i.e., the second electrode712next to electrode710) is positioned at a second location along insertion path708, where the first and second locations are in different chambers of cochlea706(e.g., the first location disposed in scala vestibuli720and the second location disposed in scala tympani716). In other words, as used herein, the multiple-electrode electrode configuration that includes both the first and second electrodes may be said to be positioned at both the first location and the second location at the same time if the electrode configuration spans both locations (i.e., at least one electrode included within the multiple-electrode electrode configuration is positioned at each location). Thus, in certain examples, system600may detect a first evoked response by way of the multiple-electrode configuration while the electrode configuration is positioned at a first location and detect a second evoked response by way of the multiple-electrode configuration while the electrode configuration is positioned at a second location without the multiple-electrode configuration moving from one location to another (e.g., while the multiple-electrode configuration remains stationary after an insertion procedure is complete).

Regardless of the timeframe over which the first and second evoked responses are detected and/or whether the electrode configurations by way of which the evoked responses are detected use single or multiple electrodes, system600may determine an at least one of an amplitude change between the first and second evoked responses and a phase change between the first and second evoked responses. Based on the amplitude change and/or the phase change that has been determined, system600may determine that the scalar translocation of electrode lead704from scala tympani716to scala vestibuli720has occurred. System600may provide this information to a user to be used in any of the ways described herein. For example, the information may be used to inform a surgical team that electrode lead704should be backed out and reinserted to try to avoid the scalar translocation prior to completing insertion procedure702, the information may be stored for reference in later insertion procedures (e.g., to inform surgical teams to take extra care at particular times or depths during the later insertion procedures), the information may be used by researchers studying the effects of scalar translocations of electrode leads to inform the researchers that a scalar translocation has occurred with respect to cochlea706, and so forth as may serve a particular implementation.

In certain examples, the approximate depth of electrode lead704into cochlea706may be known or determined at a particular time. As such, because the scalar translocation of electrode lead704may be determined to have occurred between, for instance, electrode710and the electrode712adjacent to electrode710, system600may further determine approximately where scalar translocation site724is located within cochlea706(e.g., in terms of a cochlear depth, a frequency range, etc.).

As described above, system600may determine whether a scalar translocation of an electrode lead such as electrode lead704has occurred based on a determined amplitude change and/or phase change detected between a first evoked response detected at a first location and a second evoked response detected at a second location. This is because an evoked response may be expected to have a significantly different amplitude and phase if detected at a location within scala vestibuli720as compared to if the evoked response is detected at a location within scala tympani716. Specifically, as will be described and illustrated in more detail below, an evoked response detected by the electrode configuration at a translocated location within cochlea706(e.g., a location within scala vestibuli720in the example ofFIG.7) may have a significantly lower amplitude and a phase approximately 180° offset from an evoked response detected by the electrode configuration at a non-translocated location within cochlea706(e.g., a location within scala tympani716, where electrode lead704is aimed to be kept during insertion procedure702).

As such, in certain examples, system600may determine whether the scalar translocation of the electrode lead has occurred based on a notable drop off in amplitude and/or phase from one evoked response measurement to another. However, in other examples, this determination may be complicated by the fact that other factors may also cause amplitude and/or phase changes to be detected between different cochlear locations along the insertion path, even if no scalar translocation of the electrode lead has occurred. Specifically, for example, evoked responses at locations within the cochlea leading up to a depth associated with a particular frequency (e.g., a frequency at which acoustic stimulation is applied to evoke the evoked responses being detected) may be detected to have increasing amplitudes, while evoked responses at locations within the cochlea leading away from the location associated with the particular frequency may be detected to have decreasing amplitudes.

To illustrate,FIG.7shows an exemplary depth726that may be associated with (i.e., may correspond to within the tonotopically arranged structure of the cochlea described above in relation toFIG.2) an exemplary frequency at which acoustic stimulation may be applied to the patient (e.g., to evoke the evoked responses being detected). Additionally,FIG.7shows an exemplary depth728beyond depth726(i.e., nearer to the apex of cochlea706) that may represent an anticipated final insertion depth of electrode lead704after insertion procedure702is complete. As the one or more electrodes included in the electrode configuration being used to detect evoked responses pass through entry point714and approach depth726, the amplitudes of evoked responses detected may be expected to grow increasingly larger. However, once the electrode configuration detecting the evoked responses passes depth726to continue on toward depth728, amplitudes of evoked responses detected may be expected to get increasingly smaller (e.g., dropping off by 1/e uV/mm in certain examples, where e represents Euler's number, which is approximately equal to 2.718). As such, a threshold used by system600to analyze whether a detected amplitude change may be indicative of a scalar translocation of the electrode lead may be dependent on both a frequency at which acoustic stimulation is applied to the patient to evoke the responses (e.g., the frequency associated with depth726) as well as the ultimate depth (e.g., depth728) and/or a current depth at which the evoked responses are being detected, insofar as the current depth may be determined. For example, if depth728is nearer to the apex of cochlea706than depth726as shown inFIG.7, then a detected drop off in evoked response amplitudes detected by way of electrode710may indicate either that electrode710has passed depth726or that electrode710has translocated into scala vestibuli720. As such, the threshold against which amplitude measurements are compared may take this into account (e.g., allowing for an amplitude drop less than a particular threshold such as about 1/e uV/mm in some examples before determining that a scalar translocation of the electrode lead may have occurred).

To illustrate,FIGS.8A-8Bshow graphs800(i.e., graphs800-1inFIG.8A and800-2inFIG.8B) of amplitude measurements802(e.g., amplitude measurements802-1in graph800-1and amplitude measurements802-2in graph800-2) of exemplary evoked responses detected during exemplary insertion procedures. For example, graph800-1inFIG.8Amay illustrate an exemplary insertion procedure in which no scalar translocation of the electrode lead occurs, while graph800-2inFIG.8Bmay illustrate a different exemplary insertion procedure (e.g., such as insertion procedure702) in which a scalar translocation of the electrode lead does occur.

Both graphs800, as well as additional graphs that will be described in more detail below, illustrate measurements taken over a period of time indicated by the x-axis. For example, these graphs may represent measurements made by way of a single electrode (e.g., a leading electrode such as electrode710) during an insertion procedure. During an insertion procedure, measurements of evoked responses (e.g., amplitude measurements, phase measurements, etc.) may be made automatically at a constant rate (e.g., once every 100-200 ms or at another suitable rate). As such, time may be closely tied to and/or may serve as a useful analog for insertion depth or electrode position within the cochlea because the electrode lead is being inserted deeper into the cochlea as time passes during the procedure.

In some insertion procedure examples, systems may be in place to detect real time insertion depth of a lead as the lead is being inserted into the cochlea, and to correlate that insertion depth with amplitude or other measurements of evoked responses. Hence, in such examples, amplitude graphs such as graphs800(e.g., and/or phase graphs such as will be described below) may be provided (e.g., to surgeons and/or others performing the insertion procedure) that represent measured amplitude and/or phase values with respect to insertion depth or electrode position within the cochlea, rather than (or in addition to) with respect to time. Similarly, it will be understood that principles described and illustrated herein with respect to time may apply with respect to measurements taken on a stationary electrode lead by way of different electrodes. Here again, the time at which such measurements are made may be less significant than the respective cochlear depths of the different electrodes performing the measurements. Hence, in these examples as well, graphs such as those illustrated inFIGS.8A and8B, as well as other graphs illustrated below, may be drawn with respect to cochlear depth, electrode position within the cochlea, or something else other than time.

As shown inFIG.8A, consecutive measurements802-1increase until the electrode configuration by way of which each measurement802-1is being made reaches a stimulation frequency depth (i.e., a depth within the cochlea associated with a frequency at which acoustic stimulation is being applied to the patient). For instance, depth726illustrated inFIG.7and described above may represent one example of such a stimulation frequency depth. After continuing past the stimulation frequency depth, graph800-1shows that amplitude measurements802-1begin to drop off. However, because the drop off occurs at a rate less than a predetermined amplitude threshold804(i.e., causing measurements802-1to stay above or approximately with a rate represented by amplitude threshold804), system600may recognize that this amplitude drop off does not indicate a scalar translocation of the electrode lead, but instead indicates that the stimulation frequency depth has been passed by the measuring electrode.

In scenarios where amplitude measurements802-1are being made during an insertion procedure (e.g., rather than with a stationary electrode lead after the insertion procedure) and where real-time lead insertion depth information is not available to correlate to measurements (e.g., but where time information is available), it will be understood that predetermined amplitude threshold804may be dependent on an average insertion speed for the particular insertion procedure. For example, predetermined amplitude threshold804may be a larger threshold (i.e., a steeper line) if a particular insertion procedure is progressing more rapidly than if the insertion procedure is progressing relatively slowly. Additionally, if measurements are made at a constant rate, it will be understood that changes between measurements (e.g., amplitude measurements802-1, as well as phase measurements described below) may be most useful (i.e., may yield the most accurate information) when the insertion speed of the lead into the cochlea remains relatively constant. Conversely, in scenarios where measurements are made while the electrode lead is stationary (e.g., and the measurements are thus represented with respect to insertion depth of the different electrodes rather than with respect to time), considerations such as insertion speed may not be relevant.

As shown, system600may determine whether the scalar translocation of the electrode lead has occurred by determining that an amplitude change806-1(also referred to as an amplitude drop806-1) between first and second evoked responses is less than amplitude threshold804. For example, amplitude change806-1may be the difference between amplitude measurements802-1associated with two consecutive evoked responses that are measured by system600and amplitude threshold804may be associated with the stimulation frequency depth at which acoustic stimulation is being applied in order to evoke the responses represented by amplitude measurements802-1, and may be expressed as an amplitude rate of change with respect to time (e.g., based on a constant time between each measurement and an average insertion speed of a lead) or with respect to insertion depth (e.g., a constant rate such as 1/e uV/mm). System600may then determine (e.g., in response to the determination that amplitude change806-1is less than amplitude threshold804) that the scalar translocation of the electrode lead has not occurred. In other words, system600may determine that, while the amplitude measurements802-1associated with amplitude change806-1do drop off significantly, the amplitude drop may be explained by passing the stimulation frequency depth and therefore is not considered to be indicative of a scalar translocation of the electrode lead.

Similarly, as shown in the example of graph800-2ofFIG.8B, consecutive measurements802-2increase until the electrode configuration reaches the stimulation frequency depth, and then, after continuing past the stimulation frequency depth, begin to drop off. However, in graph800-2, the rates of decrease between certain amplitude measurements802-2are much greater than the rates of decrease shown in graph800-1. For example, an amplitude change806-2(also referred to as an amplitude drop806-2) between first and second evoked responses represented by amplitude measurements802-2associated with amplitude change806-2shows a drop off considerably more significant than the amplitude threshold804(i.e., causing measurements802-2to drop below the rate represented by amplitude threshold804). Accordingly, system600may determine that this amplitude drop may indeed indicate that a scalar translocation of the electrode lead has occurred and may proceed to verify whether such a scalar translocation has occurred by analyzing a corresponding phase change associated with amplitude drop806-2.

It will be understood that in certain examples, the magnitude of amplitude drop806-2may, in and of itself, indicate that the scalar translocation of the electrode lead has occurred and system600may determine as much from amplitude measurements802-2alone. However, in other examples, it may be necessary or desirable to verify that the scalar translocation of the electrode lead has occurred by analyzing a corresponding phase change as will be described below. By the same token, it will be understood that, because the phase change of evoked responses may further indicate, along with the amplitude change, whether a scalar translocation is likely to have occurred, amplitude threshold804may be set so as to not take into account an amplitude drop expected after the electrode configuration passes the stimulation frequency depth. For example, amplitude threshold804may be set (i.e., predetermined at a level) such that both amplitude drops806-1and806-2would be greater than amplitude threshold804and would indicate the possibility of a scalar translocation of the electrode lead. Thus, in this example, an analysis of a phase change associated with each amplitude drop806could be used to determine whether the scalar translocation of the electrode lead has occurred or whether the stimulation frequency depth has merely been passed by the electrode configuration measuring the evoked responses.

To illustrate how a phase change corresponding to a threshold amplitude change may be used to determine whether (or verify that) a scalar translocation of the electrode lead has occurred,FIGS.9through11show respective graphs of phase measurements of exemplary evoked responses detected during exemplary insertion procedures with respect to time. The threshold amplitude change illustrated in each ofFIGS.9through11may represent an amplitude drop greater than a predetermined amplitude threshold such as illustrated by amplitude drop806-2(or by an amplitude drop like806-1in examples where, as mentioned above, amplitude threshold804is set so as to not take into account an expected amplitude drop after the stimulation frequency depth is passed by the electrode configuration measuring the evoked responses). As such,FIGS.9through11illustrate respective phase changes corresponding to such threshold amplitude changes. In other words, phase changes that may be analyzed by system600(i.e., due to a corresponding threshold amplitude change) are marked with boxes labeled “Threshold Amplitude Change (806)” inFIGS.9through11.

As mentioned above, if a scalar translocation of the electrode lead occurs, a phase change of approximately 180° (i.e., π radians) is expected to be detected between evoked responses associated with a location in one scala of the cochlea (e.g., the scala vestibuli) and evoked responses associated with a location in another scala of the cochlea (e.g., the scala tympani). However, detecting smaller phase changes between different locations within the same scala of the cochlea is also normally to be expected. Accordingly, system600may determine that the scalar translocation of the electrode lead has occurred only if a phase change (e.g., between two consecutive evoked response measurements) is detected to be approximately 180° for evoked responses that correspond to an amplitude drop that exceeds an amplitude threshold such as amplitude threshold804. For instance, system600may detect that the phase change is greater than one phase threshold (e.g., a phase threshold less than 180°) and, in some examples, that the phase change is also less than another phase threshold (e.g., a phase threshold greater than 180°).

For example, a graph900shown inFIG.9illustrates a plurality of phase measurements902plotted along graph900. As described above in relation toFIGS.8A and8B, while phase measurements902in graph900are plotted with respect to time (e.g., the time elapsing during an insertion procedure such as insertion procedure702) inFIG.9, it will be understood that, in other examples, phase measurements902may be plotted with respect to insertion depth. While not explicitly stated, it will be further understood that this may also be the case for other graphs depicting phase measurements described below inFIGS.10and11.

As shown, a predetermined phase threshold904(e.g., a threshold large enough to allow for minor phase changes but small enough to be surpassed by a phase change of approximately 180°) is depicted relative to a first phase measurement902associated with the threshold amplitude change. A phase change906between that phase measurement902and the subsequent phase measurement902is also shown. Because phase change906is not greater than phase threshold904, system600may determine that a scalar translocation of the electrode lead has not occurred, but, rather, that the threshold amplitude change of amplitude drop806is caused by something other than a scalar translocation of the electrode lead (e.g., such as by the electrode configuration measuring the evoked responses passing the stimulation frequency depth).

In sum, system600may determine whether the scalar translocation of the electrode lead has occurred by, first, determining that an amplitude change (e.g., one of amplitude drops806) is greater than a predetermined amplitude threshold associated with a frequency at which the acoustic stimulation is applied (i.e., amplitude threshold804). Subsequently, in response to the determination that the amplitude change is greater than the predetermined amplitude threshold, system600may determine that phase change906is less than phase threshold904. Finally, in response to the determination that phase change906is less than phase threshold904, system600may determine that a scalar translocation of the electrode lead has not occurred.

In another example, a graph1000shown inFIG.10illustrates a plurality of phase measurements1002plotted along graph1000with respect to time, similar to graph900. As shown, a predetermined phase threshold1004-1(e.g., a minimum threshold large enough to allow for minor phase changes but small enough to be surpassed by a phase change of approximately 180°) is depicted relative to a first phase measurement1002associated with the threshold amplitude change. Additionally, another predetermined phase threshold1004-2(e.g., a maximum threshold large enough to not be surpassed by a phase change of approximately 180° but small enough to be surpassed by a phase change of approximately 360°) is also shown. A phase change1006between the first phase measurement1002associated with the threshold amplitude change and the subsequent phase measurement1002is also illustrated. Because phase change1006is greater than phase threshold1004-1, system600may, in certain examples, determine that a scalar translocation of the electrode lead has occurred. However, because phase change1006is also greater than phase threshold1004-2, system600may instead, in other examples, determine that the threshold amplitude change of amplitude drop806is caused by something other than a scalar translocation of the electrode lead (e.g., such as by the electrode configuration measuring the evoked responses passing the stimulation frequency depth). This is because phase change1006is so large (approximately 360°) that it actually may represent a relatively minor phase change that only appears large due to an artifact of how evoked responses are measured and/or represented. In reality, a phase change of 360° may be identical to a phase change of 0°; thus, certain implementations may set both a minimum and a maximum phase threshold1004(i.e., minimum phase threshold1004-1and maximum phase threshold1004-2) to ensure that phase change1006is within range of the 180° phase change that is expected to be measured if a scalar translocation of the electrode lead has occurred.

In yet another example, a graph1100shown inFIG.11illustrates a plurality of phase measurements1102plotted along graph1100with respect to time, similar to graphs900and1000. As in graphs900and1000, a predetermined phase threshold1104(e.g., a threshold large enough to allow for minor phase changes but small enough to be surpassed by a phase change of approximately 180°) is depicted relative to a first phase measurement1102associated with the threshold amplitude change. In this example, phase threshold1104may represent a minimum phase threshold (i.e., analogous to phase threshold1004-1). However, it will be understood that a maximum phase threshold analogous to phase threshold1004-2may additionally or alternatively be included in other similar examples. A phase change1106between the first phase measurement1102associated with the threshold amplitude change and the subsequent phase measurement1102is also shown. Because phase change1106is greater than phase threshold1104, system600may determine that a scalar translocation of the electrode lead has occurred.

In sum, system600may determine whether the scalar translocation of the electrode lead has occurred by, first, determining that an amplitude change (e.g., one of amplitude drops806) is greater than a predetermined amplitude threshold associated with a frequency at which the acoustic stimulation is applied (i.e., amplitude threshold804). Subsequently, in response to the determination that the amplitude change is greater than the predetermined amplitude threshold, system600may determine that phase change1106is greater than phase threshold1104. Finally, in response to the determination that phase change1106is greater than phase threshold1104, system600may determine that the scalar translocation of the electrode lead has occurred.

FIG.12illustrates a method1200for detecting scalar translocation of an electrode lead within a cochlea of a cochlear implant patient. One or more of the operations shown inFIG.12may be performed by system600and/or any implementation thereof. WhileFIG.12illustrates exemplary operations according to one embodiment, other embodiments may omit, add to, reorder, and/or modify any of the operations shown inFIG.12.

In operation1202, a scalar translocation detection system associated with (e.g., communicatively coupled with, integrated by, etc.) a cochlear implant system may detect a first evoked response that occurs in response to acoustic stimulation applied to a cochlear implant patient. For example, the scalar translocation detection system may detect the first evoked response by way of an electrode configuration including at least one electrode disposed on an electrode lead included within the cochlear implant system and while the electrode configuration is positioned at a first location along an insertion path of the electrode lead into a cochlea of a cochlear implant patient. Operation1202may be performed in any of the ways described herein.

In operation1204, the scalar translocation detection system may detect a second evoked response that occurs in response to additional acoustic stimulation applied to the cochlear implant patient. For instance, the scalar translocation detection system may detect the second evoked response by way of the electrode configuration while the electrode configuration is positioned at a second location along the insertion path of the electrode lead into the cochlea. Operation1204may be performed in any of the ways described herein.

In operation1206, the scalar translocation detection system may determine at least one of an amplitude change and a phase change between the first and second evoked responses detected in operations1202and1204, respectively. Operation1206may be performed in any of the ways described herein.

In operation1208, the scalar translocation detection system may determine whether a scalar translocation of the electrode lead from one scala of the cochlea to another scala of the cochlea has occurred. In some examples, the scalar translocation detection system may determine whether the scalar translocation of the electrode lead has occurred based on the at least one of the amplitude change and the phase change determined in operation1206. Operation1208may be performed in any of the ways described herein.

In certain embodiments, one or more of the processes described herein may be implemented at least in part as instructions embodied in a non-transitory computer-readable medium and executable by one or more computing devices. In general, a processor (e.g., a microprocessor) receives instructions, from a non-transitory computer-readable medium (e.g., a memory, etc.) and executes the instructions, thereby performing one or more processes, including one or more of the processes described herein. Such instructions may be stored and/or transmitted using any of a variety of known computer-readable media.

A computer-readable medium (also referred to as a processor-readable medium) includes any non-transitory medium that participates in providing data (e.g., instructions) that may be read by a computer (e.g., by a processor of a computer). Such a medium may take many forms, including, but not limited to, non-volatile media, and/or volatile media. Non-volatile media may include, for example, optical or magnetic disks and other persistent memory. Volatile media may include, for example, dynamic random access memory (“DRAM”), which typically constitutes a main memory. Common forms of computer-readable media include, for example, a disk, hard disk, magnetic tape, any other magnetic medium, a compact disc read-only memory (“CD-ROM”), a digital video disc (“DVD”), any other optical medium, random access memory (“RAM”), programmable read-only memory (“PROM”), erasable programmable read-only memory (“EPROM”), electrically erasable programmable read-only memory (“EEPROM”), a Flash EEPROM device, any other memory chip or cartridge, or any other tangible medium from which a computer can read.

FIG.13illustrates an exemplary computing device1300that may be specifically configured to perform one or more of the processes described herein. As shown inFIG.13, computing device1300may include a communication interface1302, a processor1304, a storage device1306, and an input/output (“I/O”) module1308communicatively connected via a communication infrastructure1310. While an exemplary computing device1300is shown inFIG.13, the components illustrated inFIG.13are not intended to be limiting. Additional or alternative components may be used in other embodiments. Components of computing device1300shown inFIG.13will now be described in additional detail.

Communication interface1302may be configured to communicate with one or more computing devices. Examples of communication interface1302include, without limitation, a wired network interface (such as a network interface card), a wireless network interface (such as a wireless network interface card), a modem, an audio/video connection, and any other suitable interface.

Processor1304generally represents any type or form of processing unit capable of processing data or interpreting, executing, and/or directing execution of one or more of the instructions, processes, and/or operations described herein. Processor1304may direct execution of operations in accordance with one or more applications1312or other computer-executable instructions such as may be stored in storage device1306or another computer-readable medium.

Storage device1306may include one or more data storage media, devices, or configurations and may employ any type, form, and combination of data storage media and/or device. For example, storage device1306may include, but is not limited to, a hard drive, network drive, flash drive, magnetic disc, optical disc, RAM, dynamic RAM, other non-volatile and/or volatile data storage units, or a combination or sub-combination thereof. Electronic data, including data described herein, may be temporarily and/or permanently stored in storage device1306. For example, data representative of one or more executable applications1312configured to direct processor1304to perform any of the operations described herein may be stored within storage device1306. In some examples, data may be arranged in one or more databases residing within storage device1306.

I/O module1308may be configured to receive user input and provide user output and may include any hardware, firmware, software, or combination thereof supportive of input and output capabilities. For example, I/O module1308may include hardware and/or software for capturing user input, including, but not limited to, a keyboard or keypad, a touch screen component (e.g., touch screen display), a receiver (e.g., an RF or infrared receiver), and/or one or more input buttons.

I/O module1308may include one or more devices for presenting output to a user, including, but not limited to, a graphics engine, a display (e.g., a display screen), one or more output drivers (e.g., display drivers), one or more audio speakers, and one or more audio drivers. In certain embodiments, I/O module1308is configured to provide graphical data to a display for presentation to a user. The graphical data may be representative of one or more graphical user interfaces and/or any other graphical content as may serve a particular implementation.

In some examples, any of the facilities or systems described herein may be implemented by or within one or more components of computing device1300. For example, one or more applications1312residing within storage device1306may be configured to direct processor1304to perform one or more processes or functions associated with evoked response detection facility602or processing facility604within system600. Likewise, storage facility606within system600may be implemented by or within storage device1306.

In the preceding description, various exemplary embodiments have been described with reference to the accompanying drawings. It will, however, be evident that various modifications and changes may be made thereto, and additional embodiments may be implemented, without departing from the scope of the invention as set forth in the claims that follow. For example, certain features of one embodiment described herein may be combined with or substituted for features of another embodiment described herein. The description and drawings are accordingly to be regarded in an illustrative rather than a restrictive sense.