Unintentional stimulation management

Abstract

The invention relates to techniques for managing unintentional stimulation. The techniques relate to managing non-auditory stimulation (e.g., unintentional facial nerve stimulation), including pre-operative and intra-operative techniques for preventing unintentional non-auditory stimulation, and / or post-operative techniques for diagnosing and treating unintentional non-auditory stimulation.

Description

Technical Field

[0001] The present invention generally relates to techniques for managing unintentional stimuli, such as unintentional non-auditory stimuli. Background Art

[0002] Medical devices have provided a wide range of therapeutic benefits to recipients over the last several decades. Medical devices may include internal or implantable components / devices, external or wearable components / devices, or combinations thereof (e.g., devices having external components that communicate with implantable components). Medical devices, such as traditional hearing aids, partially or fully implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful for many years in performing life-saving and / or lifestyle-improving functions and / or recipient monitoring.

[0003] Over the years, the types of medical devices and the range of functions performed by them have increased. For example, many medical devices, sometimes referred to as "implantable medical devices," now typically include one or more instruments, devices, sensors, processors, controllers, or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient's body. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage disease / injury or its symptoms, or to study, replace, or modify anatomical structures or physiological processes. Many of these functional devices utilize power and / or data received from an external device that is part of or operates in conjunction with the implantable component. Summary of the invention

[0004] In one aspect, a method is provided. The method includes obtaining a preoperative image of an inner ear of a recipient; analyzing the preoperative image using a computing device to determine a risk of unintentional facial nerve stimulation associated with inserting a stimulation assembly into the inner ear; and outputting information about the risk of unintentional facial nerve stimulation associated with inserting the stimulation assembly into the inner ear using the computing device.

[0005] In another aspect, a method is provided. The method includes: after inserting a stimulation assembly at least partially into an inner ear of a recipient; performing a plurality of electrical measurements via electrodes of the stimulation assembly to obtain a plurality of electrical parameters of positioning of the stimulation assembly within the inner ear; and, at a computing device, analyzing the plurality of electrical parameters to identify a risk of unintentional stimulation associated with the positioning of the stimulation assembly within the inner ear.

[0006] In another aspect, a method is provided. The method includes: capturing a plurality of electrical values ​​via electrodes of a stimulation assembly implanted in an inner ear of a recipient, wherein the stimulation assembly is a component of a medical device configured to deliver electrical stimulation signals to the inner ear; determining, based on the plurality of electrical values, that the recipient has an elevated risk of unintentional facial nerve stimulation from at least one identified electrode of the stimulation assembly; and setting at least one electrode channel configuration for use by the medical device when delivering electrical stimulation to the inner ear via the stimulation assembly to remediate the elevated risk of unintentional facial nerve stimulation from the at least one identified electrode.

[0007] In another aspect, one or more non-transitory computer-readable storage media are provided. The one or more non-transitory computer-readable storage media include instructions executable to: obtain a plurality of electrical values ​​captured via electrodes of a stimulation assembly implanted in an inner ear of a recipient, wherein the stimulation assembly is a component of a medical device configured to deliver electrical stimulation signals to the inner ear; based on the plurality of electrical values, determine that the recipient has an elevated risk of stimulation side effects from at least one identified electrode of the stimulation assembly; and output a recommendation for setting at least one electrode channel configuration for use by the medical device when delivering electrical stimulation to the inner ear via the stimulation assembly to remedy the elevated risk of stimulation side effects from the at least one identified electrode.

[0008] In another aspect, an apparatus is provided. The apparatus comprises: an input device configured to obtain a plurality of electrical measurements captured via electrodes of a stimulation assembly positioned in an inner ear of a recipient; and at least one processor configured to analyze the plurality of electrical measurements and output an indication of a risk of unintentional non-auditory stimulation associated with the positioning of the stimulation assembly within the inner ear.

[0009] In another aspect, a system is provided. The system includes: a medical device including a plurality of electrodes configured to be inserted into a recipient; and a computing device including: an input device in communication with the implantable medical device and configured to receive intraoperative measurements performed via one or more of the plurality of electrodes; and one or more processors configured to estimate a risk of a stimulation side effect from at least one of the plurality of electrodes using the intraoperative measurements and to adjust the operation of the medical device to remedy the risk of the stimulation side effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Embodiments of the present invention are described herein with reference to the accompanying drawings, in which:

[0011] Figure 1A is a schematic diagram illustrating a cochlear implant system with which aspects of the technology presented herein may be implemented;

[0012] Figure 1B It is wearable Figure 1A A side view of a recipient of a sound processing unit of a cochlear implant system;

[0013] Figure 1C yes Figure 1A A schematic diagram of components of a cochlear implant system;

[0014] Figure 1D yes Figure 1A Block diagram of a cochlear implant system;

[0015] Figure 2A and 2B is a schematic diagram showing the anatomical structure of the human cochlea;

[0016] Figure 2C is a schematic diagram showing the spatial relationship of the recipient's facial nerve function to the recipient's cochlea and internal auditory canal;

[0017] Figure 2D is a computed tomography (CT) image showing a case of cochleo-facial dehiscence (CFD), in which the normal thin wall connecting the facial nerve canal to the cochlear labyrinth is absent;

[0018] Figure 3 is a flow chart illustrating an exemplary method for preoperative surgical management for preventing facial nerve stimulation using a preoperative algorithm [ALGO1] according to some exemplary embodiments;

[0019] Figure 4 is a flow chart illustrating an exemplary method for intraoperative surgical management using an intraoperative algorithm [ALGO2] to prevent facial nerve stimulation according to some exemplary embodiments;

[0020] Figure 5 is a diagram showing a combination according to some exemplary embodiments Figure 4 A series of graphical views of cochlear outflow flux estimated by the ladder network method;

[0021] Figure 6 is a flow chart illustrating an exemplary method for postoperative audiological management using a postoperative diagnostic algorithm [ALGO3] to diagnose facial nerve stimulation according to some exemplary embodiments;

[0022] Figure 7 is a flow chart illustrating an exemplary method for postoperative audiological management using a postoperative recommendation algorithm [ALGO4] to diagnose and recommend facial nerve stimulation therapy according to some exemplary embodiments;

[0023] Fig. 8A is a flow chart illustrating an exemplary method for postoperative audiological management using a fully automated postoperative treatment algorithm [ALGO5] to diagnose and automatically treat facial nerve stimulation in accordance with some exemplary embodiments;

[0024] Figure 8B is a diagram showing a combination according to some exemplary embodiments Fig. 8A A graph of examples of methods where each monopolar field is modified to actively absorb some current through an identified electrode (e.g., EL14), where the percentage of current actively absorbed through the intracochlear electrode matches passive conduction through the facial nerve canal;

[0025] Fig. 9 is a functional block diagram of an implantable stimulator system that may benefit from the techniques described herein;

[0026] Fig.10 is a schematic diagram illustrating a vestibular stimulator system with which aspects of the technology presented herein may be implemented; and

[0027] Fig.11 is a schematic diagram illustrating a retinal prosthesis system with which aspects of the technology presented herein may be implemented. DETAILED DESCRIPTION

[0028] Preoperative techniques, intraoperative techniques, and postoperative techniques for managing unintentional stimulation and / or managing stimulation side effects associated with delivering electrical stimulation to a recipient are presented herein. In some aspects, these techniques relate to the management of non-auditory stimulation (e.g., unintentional facial nerve stimulation), including preoperative techniques and intraoperative techniques for preventing unintentional non-auditory stimulation, and / or postoperative techniques for diagnosing and treating unintentional non-auditory stimulation.

[0029] For ease of description only, the technology presented herein is primarily described with reference to a specific implantable medical device system (i.e., a cochlear implant system) and with reference to a specific type of unintentional non-auditory stimulation or stimulation side effect (i.e., unintentional facial nerve stimulation). However, it should be understood that the technology presented herein may also be partially or completely implemented by other types of implantable medical devices for managing different types of unintentional stimulation and / or stimulation side effects. For example, the technology presented herein may be implemented by other auditory prosthesis systems including one or more other types of auditory prostheses (e.g., middle ear auditory prostheses, bone conduction devices, direct acoustic stimulators, electroacoustic prostheses, auditory brain stimulators, combinations or variations thereof, etc.). The technology presented herein may also be implemented by proprietary tinnitus treatment devices and tinnitus treatment device systems. In additional embodiments, the technology presented herein can also be implemented by, or used in combination with, vestibular devices (e.g., vestibular implants), visual devices (i.e., bionic eyes), sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, epileptic seizure devices (e.g., devices for monitoring and / or treating epileptic events), sleep apnea devices, electroporation devices, etc.

[0030] Figures 1A-1D An exemplary cochlear implant system 102 is shown with which aspects of the technology presented herein may be implemented. The cochlear implant system 102 includes an external component 104 / implantable component 112. Figures 1A-1D In the example of a cochlear implant, the implantable component is sometimes referred to as a "cochlear implant." Figure 1A The cochlear implant 112 is shown implanted in the recipient's head 154, while Figure 1B is a schematic diagram of the outer member 104 worn on the head 154 of the recipient. Figure 1C is another schematic diagram of a cochlear implant system 102, and Figure 1D Additional details of cochlear implant system 102 are shown. For ease of description, the Figures 1A-1D .

[0031] Cochlear implant system 102 includes an external component 104 configured to be attached directly or indirectly to the body of a recipient, and an implantable component 112 configured to be implanted in the recipient. Figures 1A-1D In the example of FIG. 1 , external component 104 includes a sound processing unit 106 , while cochlear implant 112 includes an implantable coil 114 , an implant body 134 , and an elongated stimulation assembly 116 configured to be implanted in the cochlea of ​​a recipient.

[0032] exist Figures 1A-1DIn the example of the present invention, the sound processing unit 106 is an off-the-ear (OTE) sound processing unit (sometimes referred to herein as an OTE component) that is configured to send data and power to the implantable component 112. Generally speaking, the OTE sound processing unit is a component having a generally cylindrical housing 111 and configured to be magnetically coupled to the head of the recipient (e.g., including an integrated external magnet 150 configured to be magnetically coupled to an implantable magnet 152 in the implantable component 112). The OTE sound processing unit 106 also includes an integrated external (head component) coil 108 configured to be inductively coupled to the implantable coil 114.

[0033] It should be understood that the OTE sound processing unit 106 is merely illustrative of an external device that can operate with the implantable component 112. For example, in alternative examples, the external component can include a behind-the-ear (BTE) sound processing unit or a micro-BTE sound processing unit and a separate external component. Generally speaking, the BTE sound processing unit includes a housing that is shaped to be worn on the recipient's outer ear and connected to a separate external coil assembly via a cable, wherein the external coil assembly is configured to be magnetically coupled and inductively coupled to the implantable coil 114. It should also be understood that alternative external components can be located in the recipient's ear canal, worn on the body, etc.

[0034] As described above, cochlear implant system 102 includes sound processing unit 106 and cochlear implant 112. However, as further described below, cochlear implant 112 can operate independently of sound processing unit 106 for at least a period of time to stimulate a recipient. For example, cochlear implant 112 can operate in a first general mode (sometimes referred to as an "external listening mode"), in which sound processing unit 106 captures sound signals, which are then used as a basis for delivering stimulation signals to the recipient. Cochlear implant 112 can also operate in a second general mode (sometimes referred to as an "invisible hearing" mode), in which sound processing unit 106 cannot provide sound signals to cochlear implant 112 (e.g., sound processing unit 106 is not present, sound processing unit 106 is powered off, sound processing unit 106 is malfunctioning, etc.). Therefore, in the invisible hearing mode, cochlear implant 112 captures the sound signals itself via an implantable sound sensor, and then uses these sound signals as a basis for delivering stimulation signals to the recipient. Further details regarding the operation of cochlear implant 112 in the external listening mode are provided below, followed by details regarding the operation of cochlear implant 112 in the invisible listening mode. It should be understood that the reference to the external listening mode and the invisible listening mode is merely illustrative, and cochlear implant 112 may also operate in alternative modes.

[0035] exist Figure 1A and Figure 1CIn the present invention, a cochlear implant system 102 is shown with an external device 110, which is configured to implement various aspects of the technology presented. The external device 110 is a computing device, such as a computer (e.g., a laptop, a desktop computer, a tablet), a mobile phone, a remote control unit, etc. The external device 110 and the cochlear implant system 102 (e.g., an OTE sound processing unit 106 or a cochlear implant 112) communicate wirelessly via a two-way communication link 126. The two-way communication link 126 can include, for example, short-range communication, such as a Bluetooth link, a Bluetooth low energy (BLE) link, a proprietary link, etc.

[0036] Return to Figures 1A-1D In the example of the OTE sound processing unit 106, one or more input devices are configured to receive input signals (e.g., sound or data signals). The one or more input devices include one or more sound input devices 118 (e.g., one or more external microphones, audio input ports, telecoils, etc.), one or more auxiliary input devices 128 (e.g., audio ports, such as direct audio input (DAI), data ports, such as universal serial bus (USB) ports, cable ports, etc.), and wireless transmitter / receiver (transceiver) 120 (e.g., for communicating with external devices 110). However, it should be understood that the one or more input devices may include additional types of input devices and / or fewer input devices (e.g., the wireless short-range radio transceiver 120 and / or one or more auxiliary input devices 128 may be omitted).

[0037] The OTE sound processing unit 106 also includes an external coil 108, a charging coil 130, a tightly coupled transmitter / receiver (RF transceiver) 122 (sometimes referred to as a radio frequency (RF) transceiver 122), at least one rechargeable battery 132, and an external sound processing module 124. The external sound processing module 124 may include, for example, one or more processors and a memory device (memory) including sound processing logic. The memory device may include any one or more of the following: non-volatile memory (NVM), ferroelectric random access memory (FRAM), read-only memory (ROM), random access memory (RAM), magnetic disk storage media devices, optical storage media devices, flash memory devices, electrical, optical or other physical / tangible memory storage devices. The one or more processors are, for example, microprocessors or microcontrollers that execute instructions of the sound processing logic stored in the memory device.

[0038] The implantable component 112 includes an implant body (main module) 134, a lead region 136, and an intracochlear stimulation assembly 116, all configured to be implanted beneath the skin / tissue (tissue) 115 of a recipient. The implant body 134 typically includes a hermetically sealed housing 138 in which an RF interface circuit system 140 and a stimulator unit 142 are disposed. The implant body 134 also includes an internal / implantable coil 114, which is typically external to the housing 138 but is accessible via a hermetic feedthrough ( Figure 1D ) is connected to the RF interface circuit system 140.

[0039] As described, stimulation assembly 116 is configured to be at least partially implanted in the cochlea of ​​a recipient. Stimulation assembly 116 includes a carrier member (e.g., a flexible silicone body) 115 and a plurality of longitudinally spaced intracochlear electrical stimulation contacts (electrodes) 144 disposed in the carrier member. Electrodes 144 collectively form a contact or electrode array 146 for delivering electrical stimulation (electrical current) to the cochlea of ​​a recipient.

[0040] The stimulation assembly 116 extends through an opening in the recipient's cochlea (e.g., a cochlear fenestration, a round window, etc.) and has a lead region 136 and an airtight feedthrough ( Figure 1D 144 is connected to the proximal end of the stimulator unit 142. The lead region 136 includes a plurality of conductors (wires) that electrically couple the electrode 144 to the stimulator unit 142. The implantable component 112 also includes an electrode outside the cochlea, sometimes referred to as an extracochlear electrode (ECE) 139.

[0041] As described, the cochlear implant system 102 includes an external coil 108 and an implantable coil 114. An external magnet 152 is fixed relative to the external coil 108, and the implantable magnet 152 is fixed relative to the implantable coil 114. The magnets fixed relative to the external coil 108 and the implantable coil 114 facilitate operational alignment of the external coil 108 with the implantable coil 114. This operational alignment of the coils enables the external component 104 to transmit data and power to the implantable component 112 via a tightly coupled wireless link 148 formed between the external coil 108 and the implantable coil 114. In some examples, the tightly coupled wireless link 148 is a radio frequency (RF) link. However, various other types of energy transfer (e.g., infrared (IR), electromagnetic, capacitive, and inductive transfer) may be used to transfer power and / or data from the external component to the implantable component, and thus, Figure 1D Only one exemplary arrangement is shown.

[0042] As described above, the sound processing unit 106 includes an external sound processing module 124. The external sound processing module 124 is configured to convert an input signal received (received at one or more of the input devices) into an output signal for stimulating the first ear of the recipient (i.e., the external sound processing module 124 is configured to perform sound processing on the input signal received at the sound processing unit 106). In other words, the one or more processors in the external sound processing module 124 are configured to execute the sound processing logic in the memory to convert the received input signal into an output signal representing electrical stimulation for delivery to the recipient.

[0043] As stated, Figure 1D An embodiment is shown in which an external sound processing module 124 in the sound processing unit 106 generates an output signal. In an alternative embodiment, the sound processing unit 106 can send less processed information (e.g., audio data) to the implantable component 112, and the sound processing operations (e.g., conversion of sound to output signals) can be performed by a processor within the implantable component 112.

[0044] Return to Figure 1D In a specific example of the invention, the output signal is provided to the RF transceiver 122, which transmits the output signal (e.g., in an encoded manner) transcutaneously to the implantable component 112 via the external coil 108 and the implantable coil 114. That is, the output signal is received at the RF interface circuit system 140 via the implantable coil 114 and provided to the stimulator unit 142. The stimulator unit 142 is configured to generate an electrical stimulation signal (e.g., a current signal) for delivery to the cochlea of ​​the recipient using the output signal. In this way, the cochlear implant system 102 electrically stimulates the auditory nerve cells of the recipient, thereby bypassing the missing or defective hair cells that normally convert acoustic vibrations into neural activity in a manner that causes the recipient to perceive one or more components of the received sound signal.

[0045] As described in detail above, in the external listening mode, the cochlear implant 112 receives processed sound signals from the sound processing unit 106. However, in the invisible listening mode, the cochlear implant 112 is configured to capture and process the sound signals for electrical stimulation of the recipient's auditory nerve cells. Figure 1DAs shown in , the cochlear implant 112 includes a plurality of implantable sound sensors 160 and an implantable sound processing module 158. Similar to the external sound processing module 124, the implantable sound processing module 158 may include, for example, one or more processors and a memory device (memory) including sound processing logic. The memory device may include any one or more of the following: non-volatile memory (NVM), ferroelectric random access memory (FRAM), read-only memory (ROM), random access memory (RAM), magnetic disk storage media devices, optical storage media devices, flash memory devices, electrical, optical or other physical / tangible memory storage devices. The one or more processors are, for example, microprocessors or microcontrollers that execute instructions of the sound processing logic stored in the memory device.

[0046] A specific exemplary embodiment of implantable sound processing module 158 may be configured with a warp filter bank through which application of a neural health map is implemented in cochlear implant system 102, as described below with reference to Fig.10 and 11 Described in detail.

[0047] In the invisible hearing mode, the implantable sound sensor 160 is configured to detect / capture a signal (e.g., an acoustic sound signal, a vibration, etc.), which is provided to the implantable sound processing module 158. The implantable sound processing module 158 is configured to convert the received input signal (received at one or more implantable sound sensors 160) into an output signal for stimulating the first ear of the recipient (i.e., the processing module 158 is configured to perform a sound processing operation). In other words, the one or more processors in the implantable sound processing module 158 are configured to execute the sound processing logic in the memory to convert the received input signal into an output signal 156 that is provided to the stimulator unit 142. The stimulator unit 142 is configured to generate an electrical stimulation signal (e.g., an electric current signal) for delivery to the cochlea of ​​the recipient using the output signal 156, thereby bypassing the missing or defective hair cells that normally convert the acoustic vibrations into neural activity.

[0048] It should be appreciated that the above description of the so-called external listening mode and the so-called invisible listening mode is merely illustrative, and that cochlear implant system 102 may operate differently in different embodiments. For example, in an alternative embodiment of the external listening mode, cochlear implant 112 may use the signals captured by sound input device 118 and implantable sound sensor 160 to generate stimulation signals for delivery to the recipient.

[0049] Unintentional facial nerve stimulation (FNS) is a type of unintentional non-auditory stimulation (NAS) associated with, for example, stimulation of the inner ear of a recipient. More specifically, unintentional facial nerve stimulation refers to the unintentional or unintentional activation of the facial nerve, for example, due to intentional stimulation of other tissues / nerves of the recipient. For example, unintentional facial nerve stimulation is prevalent in cochlear implant recipients, with a reported incidence of approximately 5-6% of recipients. In addition, the risk of facial nerve stimulation is known to be higher for certain types of stimulation components (e.g., lateral electrodes, straight electrodes), and in recipients with cochlear malformations.

[0050] Unintentional facial nerve stimulation presents a considerable workload to practitioners (e.g., surgeons, audiologists, etc.), and in many cases, practitioners struggle to effectively treat / remedy the problem. In general, current audiological management techniques are essentially trial-and-error in nature, in which practitioners try to adjust different stimulation parameters and then solicit subjective feedback from recipients to determine whether the change(s) are effective. For example, practitioners can: (1) identify channels within the auditory stimulation range that cause unintentional facial nerve stimulation and reduce the stimulation level, (2) change strategy parameters, such as reducing the stimulation rate and increasing the pulse width, changing the pulse form (e.g., from biphasic pulses to triphasic pulses), adjusting the channel configuration / polarity mode (e.g., BP+n iso monopolar), and / or (3) deactivate channels that trigger unintentional facial nerve stimulation.

[0051] All occurred frequently and primarily in monopolar mode, with a broad set of channels causing unintentional facial nerve stimulation, thus necessitating the deactivation of a broad set of channels, resulting in damage to the auditory nerve (AN) pathway and leading to poor speech outcomes. Although few studies have reported speech outcomes, it is possible that unintentional facial nerve stimulation is an important cause of poor performance of cochlear implants.

[0052] In the unfortunate case where audiological management fails, the last option is reimplantation, which is a very dramatic complication. Unfortunately, reimplantation is not common in these severe cases.

[0053] As can be seen from the above, practitioners lack the technology to effectively manage (e.g., prevent, diagnose and / or treat) unintentional facial nerve stimulation. Therefore, this article presents preoperative techniques, intraoperative techniques, and postoperative techniques for managing unintentional facial nerve stimulation (e.g., preoperative techniques and intraoperative techniques for preventing facial nerve stimulation, and / or postoperative techniques for diagnosing and treating facial nerve stimulation).

[0054] Before explaining the techniques presented in this article, it is helpful to first gain a better understanding of the cochlear anatomy and relationship to the facial nerve.

[0055] Specifically, refer to Figure 2A-2B Describes relevant aspects of an exemplary cochlea 201. More specifically, Figure 2A is a perspective view of the cochlea 201 partially cut away to show the cochlear duct and nerve fibers, and Figure 2B It is a cross-sectional view of a circle of tubes of the cochlea 201.

[0056] First reference Figure 2A , the cochlea 201 is a conical spiral structure that includes three parallel fluid-filled tubes or ducts, collectively and generally referred to herein as tubes 203. The tubes 203 include the tympanic tube 209 (also referred to as the scala tympani 209), the vestibular tube 205 (also referred to as the scala vestibuli 205), and the middle tube 207 (also referred to as the scala media 207). The cochlea 201 spirals several times around the modiolus 213 and terminates at the cochlear apex 235.

[0057] The various portions of the cochlea 201 are encased in a bony labyrinth / capsule 217 and an endosteal membrane 221 (e.g., a thin vascular membrane of connective tissue lining the inner surface of the bone tissue that forms the medullary cavity of the bony labyrinth). The spiral ganglion cells 215 are located on the relatively inner side 231 of the cochlea 201 (e.g., Figure 2B The spiral ligament membrane 247 is located between the lateral surface 219 of the spiral tympanum 209 and the bony capsule 217, and between the lateral surface 219 of the middle scala 207 and the bony capsule 217. The spiral ligament 247 also generally extends around at least a portion of the lateral surface 219 of the scala vestibuli 205.

[0058] The fluid in the tympanic tube 209 and vestibular canal 205 (called perilymph) has different properties than the fluid (called endolymph) that fills the scala media 207 and surrounds the organ of Corti 211. Together, the tympanic tube 209 and vestibular canal 205 form the perilymph space of the cochlea 201. Sound entering the recipient's auricle (not shown) causes pressure changes in the cochlea 201 to travel through the fluid-filled tympanic tube 209 and vestibular canal 205. As noted, the organ of Corti 211 is located on the basilar membrane 225 in the scala media 207 and contains rows of 16,000-20,000 hair cells (not shown) that protrude from its surface. Above them is the tectal membrane 233, which moves in response to pressure changes in the fluid-filled tympanic tube 209 and vestibular canal 205. Small relative movements of the layers of membrane 233 are sufficient to cause the hair cells in the endolymph to move, thereby causing the generation of voltage pulses or action potentials that travel along associated nerve fibers 229. Nerve fibers 229 embedded within spiral lamina 223 connect the hair cells with spiral ganglion cells 215 that form the auditory nerve 215. The auditory nerve 215 relays the impulses to the auditory area of ​​the brain (not shown) for processing.

[0059] The location along the basilar membrane 225 where the maximum excitation of the hair cells occurs determines the perception of pitch and loudness according to position theory. Due to this anatomical arrangement, the cochlea 201 is characteristically referred to as "tone mapped." That is, areas of the cochlea 201 toward the basal region 237 respond to high frequency signals, while areas of the cochlea 201 toward the apical region 239 respond to low frequency signals. These tone mapping characteristics of the cochlea 201 are exploited in cochlear implants by delivering stimulation signals within a predetermined frequency range to the areas of the cochlea that are most sensitive to that particular frequency range.

[0060] Generally speaking, the basal region 237 is the portion of the cochlea 201 that is closest to the stapes ( Figure 2A and 2B The cochlea 201 is generally a conical spiral structure (i.e., a spiral shape) terminating at the cochlear apex 235.

[0061] Figure 2C 2 is a schematic anatomical diagram showing the anatomical relationship of the facial nerve 241 relative to the cochlea 201 , and showing that the facial nerve 241 passes through the otic capsule 243 all the way to the internal auditory meatus (internal auditory canal) 245 .

[0062] The reason for facial nerve irritation has to do with the temporal bone anatomy and the relationship between the cochlea 201 and the facial nerve 241. More specifically, the facial nerve 241 is the seventh cranial nerve that runs through the internal auditory canal 245, following the same path to the brainstem as the cochleovestibular nerve (eighth cranial nerve). On its way into the internal auditory canal 245, the facial nerve 241 passes close to the first cochlear turn (outer wall side) at an angle of about 270%. This is called the labyrinthine segment of the facial nerve 241.

[0063] At the first cochlear turn, the separation between the cochlea 201 and the facial nerve canal is formed by a thin layer of bone, and it is known that the anatomy of the face varies greatly. In some cases, the bone layer is so thin that it is just a bone shell or even absent. This is called cochlear-facial dehiscence (CFD), and examples are shown in Figure 2D That is, Figure 2D 227 is a computed tomography (CT) image of a case of a recipient suffering from severe permanent unintentional facial nerve irritation, wherein no bone layers can be seen on the CT image. Figure 2D The normal thin wall is absent (if present in the image it would appear as a white layer) connecting the facial nerve canal to the cochlear labyrinth.

[0064] The basic principle of tissue stimulation is that current delivered to / from the tissue must be removed / absorbed from the tissue (e.g., the tissue has no net charge at the end of the stimulation period). In some examples, cochlear implants stimulate by default in a monopolar mode in which current flows from intracochlear electrodes (e.g., electrodes in the cochlea), through the cochlear tissue and head, and out to one or more extracochlear reference electrodes (e.g., one or more electrodes located outside the cochlea).

[0065] Not much is known about the outflow of current in the monopolar mode. However, analysis of the transimpedance matrix (TIM) indicates that the exact flow pattern is different for each recipient. As the current leaves the cochlea, most of the monopolar current flows toward the base of the cochlea, where the cochlear aqueduct, middle ear, and internal auditory canal play a role. The apex is the second possible current sink, but the strength of this sink varies (e.g., in some recipients, the apical current draw is minimal).

[0066] The inventors have discovered that if there is a partial or cochleo-facial cleft (e.g., little or no bone casing between the first coil and the facial nerve canal), the facial nerve canal can act as a shortcut for electrical monopolar current, connecting more or less directly to the deeper segments of the internal auditory canal. Typically, aggregate volume conduction through the head tissue presents a monopolar tissue impedance of + / - 1000-1500 ohms.

[0067] Now, if most of the current enters the facial nerve canal, it may cause facial nerve action potentials, which can be transmitted in and out, causing sensations around the eyes or mouth, for example. To avoid facial nerve stimulation due to this mechanism, it is critical to keep the monopolar current away from the facial nerve canal in some way. This approach will be more effective than adjusting the stimulation parameters (e.g., rate, pulse waveform, or pulse width). These parameters do not modify the current flow pattern and will only have a secondary effect.

[0068] More specifically, if the labyrinthine segment of the facial nerve acts as a current sink, then the nearby cochlear implant electrode is located in the middle portion of the electrode array. However, on its way through the middle ear, the facial nerve also passes relatively close to the round window. Therefore, in certain abnormal anatomies or if the electrode is only partially inserted, the basilar electrode may also cause unintentional facial nerve stimulation. In cases of otosclerosis, the current flow may also be significantly different.

[0069] The normal operation of the cochlear implant makes the stimulation current / charge in the cochlea expected to generate a controlled loudness perception of the driving auditory nerve somewhere between the threshold (T) and loud but comfortable (C). For the transmission of auditory information, covering the entire dynamic range (loudness) is critical. A minimum value of electrical stimulation is required to reach the C-level. Facial nerve stimulation can set the maximum value to the stimulation level that can be delivered on a specific electrode. If unintentional facial nerve stimulation occurs before reaching a comfortable loudness, the electrode (or generally a multi-pole channel) will have a compromise function (smaller dynamic range). If they are ineffective even at a gentle level, a better audiological method is to prohibit them. This is just another condition (e.g., similar to compliance voltage) to set the maximum value to the stimulation level. If this is the case for only one or two contacts, this will have no significant effect on the hearing results. However, once 3-4 electrodes or more electrodes need to be removed, the electrode-nerve interface is significantly damaged, resulting in worse hearing results, and may need to be re-implanted.

[0070] Therefore, as described above, there is an unmet need for systems and technologies that can help prevent, diagnose and effectively treat unintentional facial nerve stimulation so that recipients no longer suffer from adverse consequences caused by unintentional facial nerve stimulation. Current practice is an expert approach that requires a lot of specialized experience and is at risk of the general recipient population not being adequately supported by any currently available diagnostic or treatment tools. Current management of unintentional facial nerve stimulation is clinician-directed and assisted by the recipient's perception. This results in an inconsistent approach that can take a lot of clinical time.

[0071] In order to solve the above reference Figures 1A-1D In response to these and other needs related to the described systems, devices, and components, techniques are presented herein for managing facial nerve stimulation surgically and / or audiologically in conjunction with implantable components of implantable medical devices. Specifically, preoperative and intraoperative techniques for preventing facial nerve stimulation, as well as postoperative techniques for diagnosing and treating facial nerve stimulation, are presented herein. The techniques presented herein provide surgeons and clinicians with actionable data resulting in more consistent and timely treatment of unintentional facial nerve stimulation, and can be built on transimpedance measurement techniques and trained with current flow models. It should be recognized that the techniques presented below with reference to Figure 3 -8 The techniques (method steps and algorithms) described may be implemented using one or more computing devices (including one or more processors and one or more memories), such as Figures 1A-1D The system is implemented by a computing device (including but not limited to the external device 211, the external sound processing module 225 of the sound processing unit 207 of the external component 205, the implantable sound processing module 158 of the implant body 235 of the cochlear implant 213, or a combination thereof). Some steps and processing operations may be distributed among multiple components of the system. Next, the following reference Figure 3 and 4 -5 (methods 300 and 400) describe surgical management of facial nerve stimulation, and then the following will refer to Figure 6 , 7 and 8A-8B (methods 600, 700, and 800) describe audiological management of facial nerve stimulation.

[0072] Surgical management

[0073] Prevention of unintentional facial nerve stimulation is an advantageous approach, but surgeons are currently not fully aware of the risk / likelihood of unintentional facial nerve stimulation. According to various aspects presented herein, at least two tools are provided to inform surgeons of the risk of unintentional facial nerve stimulation during a particular procedure.

[0074] (Preoperative ALGO1) If preoperative computed tomography (CT) images and / or magnetic resonance imaging (MRI) images are available, practitioners (e.g., surgeons, radiologists, etc.) can manually examine these images to check for cochleo-facial dehiscence (CFD). However, this is time-consuming and cumbersome. Therefore, according to certain embodiments presented herein, when CT images or MRI images are available, a method according to one aspect of the present invention can use a segmentation algorithm to track the facial nerve canal and the first cochlear turn (basal gyrus), and determine its closest point to the basal gyrus (calculating or estimating the closest geometric distance between the facial nerve and the first cochlear turn, and the possible electrical distance by considering bone density). This distance information (and / or the future probability or possibility of unintentional facial nerve stimulation) can then be presented to the surgeon. If the distance is abnormally short, the surgeon can be warned and the image output can be converted into a probability of unintentional facial nerve stimulation and a possible position according to the insertion angle.

[0075] Existing surgical insertion procedures can be enriched with this feature, and, for example, the surgeon can then consider whether it is better to choose a different electrode type (e.g., a circummodiolar electrode instead of a lateral / straight electrode) or change the insertion technique (e.g., insertion location, positioning and / or angle). In some exemplary embodiments, in addition to forewarning the risk of unintentional facial nerve stimulation, the preoperative algorithm (ALGO1) can also automatically suggest an electrode type (e.g., use a circummodiolar electrode) in cases of abnormally short distances. Lateral / straight electrodes tend to be on the outer wall of the cochlea, while circummodiolar electrodes spontaneously position themselves on the inner wall of the cochlea. The algorithm can be considered a classification algorithm (e.g., determining whether the bone value is below or above a certain threshold), or it can generate a number (e.g., a percentage) indicating the probability of unintentional facial nerve stimulation based on several inputs (including electrode type). Future algorithms may potentially generate a higher probability of unintentional facial nerve stimulation for CI622 than for CI632 based on assumed electrode positioning. If there is sufficient field data, the probability of unintentional facial nerve stimulation can be adjusted based on, for example, electrode position (affected by surgical technique).

[0076] As described elsewhere herein, the risk of unintentional facial nerve stimulation can depend on, for example, the mechanical properties (i.e., type) of the stimulation component inserted into the cochlea. That is, different types of stimulation components (e.g., peri-modiolar / mid-modiolar / lateral, full ring / semi-ring, etc.) can have different mechanical properties, resulting in different trajectories and / or different implant locations. In addition, the risk of unintentional facial nerve stimulation can vary with different surgical approaches / techniques (e.g., round window insertion, cochlear fenestration insertion, approach angle, insertion depth, etc.). Therefore, these different parameters (e.g., mechanical properties, surgical technique, etc.) can be taken into account, and guidance can be provided to the surgeon, for example, regarding the selection of appropriate stimulation components, surgical techniques, etc.

[0077] Figure 3 is a flow chart illustrating an exemplary method 300 for preoperative surgical management using a preoperative algorithm [ALGO1] to prevent facial nerve stimulation. Figure 3 The method 300 includes obtaining a preoperative image (e.g., an MRI scan or a CT scan) of the inner ear of a recipient as a starting step (S310). Using a computing device (e.g., Figures 1A-1DThe method 300 includes analyzing preoperative images to determine a risk of facial nerve stimulation associated with inserting a stimulation assembly into the inner ear (S320), for example, by analyzing whether a cochlear-facial dehiscence (CFD) exists, in particular through an exemplary embodiment. For example, step S320 may include the following sub-steps: determining the closest distance between the recipient's facial nerve canal and the first cochlear turn (basal gyrus) of the inner ear using an image segmentation process (S322), and determining that the distance is less than a threshold distance (S324). In response to determining that there is a potential risk of unintentional facial nerve stimulation occurring (the distance is less than the threshold), the method 300 also includes outputting information about the risk of unintentional facial nerve stimulation (and / or characterizing the detected CFD). For example, step S330 may also include the following sub-step: generating a warning output indicating that the recipient is at risk of unintentional facial nerve stimulation after inserting the stimulation component into the inner ear (e.g., including the probability of unintentional facial nerve stimulation, and / or an estimate of the location within the inner ear where unintentional facial nerve stimulation may occur according to the insertion angle) (S332). Additionally or alternatively, step S330 may also include the following sub-step: outputting a recommendation for the type of stimulation component that reduces the risk of unintentional facial nerve stimulation (e.g., using a circummodiolar electrode instead of a lateral / straight electrode) (S336).

[0078] Method 300 (Preoperative ALGO1) is configured to determine the minimum physical distance between the recipient's facial nerve canal and the location closest to the basal gyrus, which is then converted into surgical / clinically relevant information in the context of cochlear implantation (using other inputs). For example, this algorithm is implemented as a segmentation algorithm of a CT image to solve for the distance. The software feature (Preoperative ALGO1) is established based on imaging and analysis of the thickness of the bone layer that separates the cochlear labyrinth from the facial nerve canal. Method 300 (ALGO1) can indicate to the surgeon the risk of future unintentional facial nerve stimulation issues based on anatomical analysis of preoperative CT images (thickness measurements + thresholding). Therefore, in the above and in combination Figure 3 The preoperative algorithm (ALGO1) described in method 300 can help an expert surgeon adjust electrode type selection, surgical technique, and / or electrode positioning during implantation surgery to prevent the occurrence (or reduce the risk of the occurrence) of unintentional facial nerve stimulation.

[0079] (Intraoperative ALGO2) A second preventive technique is to perform a diagnosis and possible adjustments during surgery before wound closure. If unintentional facial nerve stimulation is detected in the operating room (OR), the surgeon can intervene, for example by repositioning the electrode. In some examples, some advanced numerical techniques can be used to analyze the transimpedance matrix (TIM) measurements (e.g., 2x22 TIM measurements) to estimate current outflow. In some exemplary embodiments, it may be sufficient to perform a TIM measurement and run a second detection / prediction algorithm to analyze the TIM and estimate the probability of unintentional facial nerve stimulation based on the TIM analysis. Therefore, a method according to another aspect of the present invention can perform a diagnosis based on a transimpedance matrix (TIM), whereby the method performs a TIM measurement and uses an intelligent agent to analyze the TIM measurement to determine whether a (third) current absorption (e.g., a sudden change or reversal in slope) occurs, and if a third current absorption occurs, the method determines its intensity and range. This number (e.g., a percentage) can be displayed to the surgeon, who can then decide to modify the positioning of the electrode or reimplant it.

[0080] Figure 4 is a flow chart illustrating an exemplary method 400 for intraoperative surgical management using an intraoperative algorithm [ALGO2] to prevent facial nerve stimulation. Figure 4 The method 400 begins with a step (S410) involving inserting (or at least partially inserting) a stimulation assembly into an inner ear of a recipient. Figure 4 The insertion time may be at some point in time after the stimulation assembly is inserted (not shown). In some exemplary embodiments, the insertion time may be during an implantation procedure in an operating room. Method 400 includes performing a plurality of electrical measurements (e.g., voltage measurements) via electrodes of the stimulation assembly to obtain a plurality of electrical parameters of at least a first positioning of the stimulation assembly within the inner ear (S420). For example, step S420 may include the following sub-steps: determining at least one transimpedance matrix of the first positioning of the stimulation assembly within the inner ear using the plurality of electrical (voltage) measurements (S424). Using a computing device (e.g., Figures 1A-1DThe method 400 further comprises analyzing a plurality of electrical parameters (voltages) to identify a risk of facial nerve stimulation associated with a first positioning of the stimulation component within the inner ear (S430). For example, step S430 may include the following sub-steps: analyzing a plurality of electrical parameters (voltages, currents, TIMs) to estimate one or more locations where current flows out of the inner ear at the first positioning of the stimulation component within the inner ear (S432). In addition, the method 400 may include outputting, using a computing device, information about a risk of unintentional facial nerve stimulation associated with the first positioning of the stimulation component within the inner ear (S440). For example, this information may indicate the location of one or more potential electrodes with an increased risk of causing facial nerve stimulation from within the inner ear. In addition, the method 400 may include determining, using a computing device, that the first positioning of the stimulation component within the inner ear is associated with an increased risk of facial nerve stimulation (S450). In some exemplary embodiments, step S440 may include the following sub-steps: in response to determining that the first positioning of the stimulation component within the inner ear is associated with an increased risk of unintentional facial nerve stimulation, outputting a recommendation for surgical intervention to reposition the stimulation component within the inner ear (S442). In some other exemplary embodiments, step S440 may include the following sub-steps: in response to determining that the first positioning of the stimulation component within the inner ear is associated with an increased risk of unintentional facial nerve stimulation, outputting a recommendation to insert a different type of stimulation component into the inner ear to reduce the risk of facial nerve stimulation (e.g., using a peri-modiolar electrode instead of a lateral / straight electrode) (S446).

[0081] Figure 5 It shows the combination Figure 4 A series of graphical views of method 400 of estimating cochlear outflow flux by a ladder network method. There are several possible methods for analyzing the TIM matrix. One method uses a lumped element method, where a ladder model consisting of transverse resistors and longitudinal resistors is estimated to approximate the current flow within the cochlea. This is shown in FIG. Figure 5 , which provides an example of an unintentional facial nerve stimulation case. For those experienced in this field, the upper left TIM measurement ( Figure 5Sub-figure 521 of ) clearly shows that a large amount of current is flowing out of the cochlea near electrode 15. There is a clear change in the slope of the "tail" at EL15. For stimulation at the more basal electrodes (1-14), the more apical voltage (impedance) measurements become horizontal. No further voltage drop means that there is no further current flow in the apical direction. All the incoming current has left the cochlea. Similarly, when stimulating the more apical electrodes (EL16-22), there is a clear bend at EL14. The basal slope (voltage drop) levels off after EL15, meaning that either a large amount of current has left the cochlea or the conductivity of the cochlea has changed (where, according to Ohm's law, V = I x R). The latter situation is extremely unlikely. Upper right panel ( Figure 5 Subfigure 553 of ) shows that for each stimulation electrode (monopolar usage: stimulation channel = stimulation electrode), a transverse current flows near a certain recording location. In this example, a trapezoidal model is used to calculate this current flow. Other methods can be used. The outflow flux is presented as a percentage of the stimulation current. For example, when stimulating at EL22, about 12% of the current leaves the cochlea through transverse resistor 22. In general, most of the current leaves near the base (EL1) or the apex (EL22), regardless of the stimulation location.

[0082] However, this is atypical, as these slope changes are also seen around EL15, and an increase in outflow flux is observed around EL14-15. Figure 5 Sub-figure 555 of ) plots the percent outflow averaged over all stimulation locations. A peak is seen near EL14, indicating that 6% of the current is leaving the cochlea near EL14, presumably because this is where the current is able to escape from the cochlea by diving into the facial nerve canal. It can then be inferred that the occurrence of strong, significant on-site slope changes is relatively rare and is a strong indicator of unintentional facial nerve stimulation.

[0083] Assuming a reliable data set is available, an algorithm can be designed to analyze the TIM metric to obtain the risk of unintentional facial nerve stimulation. The third current absorption does not occur frequently. In order to provide a reliable estimate of later unintentional facial nerve stimulation, a sensitive and specific unintentional facial nerve stimulation detection / prediction algorithm should be developed using TIM or other derived features (e.g., ladder network current) as predictive features. An exemplary general approach is to collect a large balanced database of intraoperative TIM measurements with and without (later) case reports of unintentional facial nerve stimulation. Then, training, validation, and test sets can be constructed using classical statistical classification methods or machine learning algorithms to establish a reliable detector. For further validation, the clinician can use a facial nerve monitor in the operating room to confirm that unintentional facial nerve stimulation has occurred (e.g., by recording eyelid movements).

[0084] Lower right screen ( Figure 5Sub-figure 557 of (557) is a first attempt to design such an unintentional facial nerve stimulation prediction algorithm. The transverse current is weighted as a function of Itrans (transverse current) as a function of the probability of indicating unintentional facial nerve stimulation (pFNS). In this example, only the first 5 apical electrodes and the base electrodes are assumed to have a reduced probability of generating unintentional facial nerve stimulation (note that this assumption can be based on real data (if available) or can be estimated from field data in the future). Clearly, a peak is observed near EL14.

[0085] This intraoperative unintentional facial nerve stimulation predictor can provide information to the surgeon in the operating room when surgical intervention is still feasible (e.g., by repositioning the electrodes). It is possible that an advanced form of this algorithm can indicate the extent of unintentional facial nerve stimulation (e.g., is it a strong current absorption? What is the likely extent, e.g., are only a few electrodes generating unintentional facial nerve stimulation? etc.). If the surgeon also applies facial nerve monitoring in the operating room, it should even be possible to estimate the stimulation level that causes unintentional facial nerve stimulation and compare this level to the typical C-level of the population value or recipient-specific tNRT value (in these cases where facial nerve contribution is included).

[0086] Thus, in accordance with some exemplary embodiments, method 400 (intraoperative ALGO2) performs electrical impedance measurements to locate the presence of current absorption indicative of potential facial nerve stimulation (the method is deployed intraoperatively in the OR during surgery) and is converted into surgical / clinically relevant information in the context of cochlear implantation (e.g., implemented as a ladder network model of TIM measurements). A diagnostic tool is provided to perform electrical measurements (e.g., identify voltage and / or output current patterns) (ALGO2), and analyze the transimpedance matrix (TIM) to indicate the risk of facial nerve stimulation, and / or identify electrodes that may cause unintentional facial nerve stimulation. The decision algorithm (ALGO2) is smart enough (through machine learning from examples or other artificial intelligence) to predict whether a clinical problem is likely to occur, and under which conditions (e.g., which electrodes, which stimulation levels), so that the surgeon can apply this information while still in the OR. This may require establishing a data set of problem cases and normal cases, and identifying various features (not necessarily ladder network analysis) that are fed into a classification algorithm. Thus, in the above and in combination with Figure 4-5 The intraoperative algorithm (ALGO2) described in method 400 can help the expert surgeon adjust electrode selection, surgical technique and / or reposition the electrodes during the implantation procedure while in the operating room to prevent the occurrence (or reduce the risk of its occurrence) of unintentional facial nerve stimulation.

[0087] Audiology Management

[0088] If the surgeon does not detect unintentional facial nerve stimulation in the operating room (e.g., via intraoperative ALGO2, method 400), unintentional facial nerve stimulation may be detected during the first fitting process with the audiologist. Once again, the audiologist is currently unaware. Overall incidence data is known, but there is no diagnostic tool to inform the audiologist of the risk of unintentional facial nerve stimulation prior to the activation process. If during activation mapping, the recipient mentions non-auditory stimulation, the audiologist uses his or her own experience, essentially trying a trial and error approach to determine which channels (or electrodes) cause unintentional facial nerve stimulation and at what stimulation levels, and whether to disable those channels / electrodes. The primary determining factor here should be whether sufficient loudness can be elicited before annoying facial nerve perception occurs.

[0089] (Diagnostic ALGO3) A much better scenario would be if the audiologist could (proactively in advance or afterward) run a TIM measurement and unintentional facial nerve stimulation prediction algorithm. This diagnostic tool would create workflow efficiencies for the healthcare or practicing physician because the physician (e.g., audiologist) would receive information about which electrodes are near which current absorption is occurring. The audiologist could then focus their efforts on this location. It should be recognized that postoperative TIM is somewhat different from intraoperative TIM (e.g., due to the fibrotic process). Therefore, it is likely that the above description of the TIM measurement and unintentional facial nerve stimulation prediction algorithm will be more accurate. Figure 4 A postoperative unintentional facial nerve stimulation prediction tool described by intraoperative cases of will require a different training set. As described below, the unintentional facial nerve stimulation diagnostic tool may include an unintentional facial nerve stimulation thresholding procedure in which the minimum stimulation level that causes unintentional facial nerve stimulation is determined. Once this threshold is known, the maximum stimulation level on other electrodes can also be estimated (e.g., using a ladder network model).

[0090] Therefore, the postoperative algorithm (ALGO3) performs a diagnosis during the first fitting to diagnose FNS, and the method involves locating the facial nerve (in terms of the electrodes) and informing the audiologist of the likely location of the most sensitive channel (electrode) causing unintentional facial nerve stimulation. This diagnostic algorithm can be guided by existing knowledge (training data set) from operating room analysis (if available) (e.g., from intraoperative ALGO2 for the same recipient and / or other similar case studies). Figure 6 The described postoperative algorithm (ALGO3) can assist audiologists or other healthcare professionals in managing complex cases of unintentional facial nerve stimulation sometime after implant surgery.

[0091] Figure 6 is a flow chart illustrating an exemplary method 600 for postoperative audiological management using a postoperative diagnostic algorithm (ALGO3) to diagnose unintentional facial nerve stimulation. Figure 6The method 600 begins with a step involving implanting a stimulation assembly into the inner ear of a recipient. Figure 6 The method 600 includes performing electrical measurements (e.g., voltage measurements) via electrodes of the stimulation assembly implanted in the inner ear of the recipient to obtain electrical parameters (e.g., voltage) of a first positioning of the stimulation assembly in the inner ear (S610). For example, step S610 may include the following sub-steps: determining a transimpedance matrix (TIM) of the first positioning of the stimulation assembly in the inner ear using the electrical (voltage) measurements (S614). Using a computing device (e.g., Figures 1A-1D The method 600 further comprises analyzing electrical parameters (voltage) to identify a risk of unintentional facial nerve stimulation associated with a first positioning of the stimulation component within the inner ear (S620). For example, step S620 may include the following sub-steps: analyzing electrical parameters (voltage, current, TIM) to estimate one or more locations where current flows out of the inner ear at the first positioning of the stimulation component within the inner ear (S622). In addition, the method 600 may include outputting information about the risk of unintentional facial nerve stimulation associated with the first positioning of the stimulation component within the inner ear using a computing device (S630). For example, this information may indicate the location of potential electrodes that have an increased risk of causing unintentional facial nerve stimulation from within the inner ear.

[0092] Therefore, in some exemplary embodiments, Figure 6 Method 600 includes performing electrical impedance measurements to locate the presence of current absorption indicating potential unintentional facial nerve stimulation (the method is deployed post-operatively in the clinic), and converting into surgical / clinically relevant information in the context of cochlear implantation (e.g., implemented as a ladder network model of TIM measurements). A diagnostic tool (ALGO3) is provided for identifying output current patterns, which analyzes the transimpedance matrix to indicate the risk of unintentional facial nerve stimulation, and identifies electrodes that may cause unintentional facial nerve stimulation. The decision algorithm (ALGO3) is smart enough (through machine learning from examples) to predict whether clinical problems are likely to occur and under which conditions (e.g., which electrodes, which stimulation levels), so that the audiologist can apply this information at the activation time after the surgery has been completed. This may also require building a data set of problem cases and normal cases, and identifying various features that are fed into the classification algorithm (not necessarily ladder network analysis).

[0093] If the recipient experiences unintentional facial nerve stimulation, treatment techniques involving reprogramming the device may still allow the recipient to hear clearly. According to the following additional aspects of the invention, the audiologist has at least two recommendation options and treatment tools, which can be built upon the above combined diagnosis ALGO3 and Figure 6 The method 600 is described technically.

[0094] (ALGO4 is recommended) The first option is to optimize the recipient's "map" (e.g., sound processing settings) without changing the stimulation strategy. The first recommendation tool can assist the audiologist in remapping and can inform the practitioner by estimating the maximum stimulation level on each electrode or channel rather than measuring the stimulation level. If one facial nerve threshold is known (e.g., at the electrode closest to it), the TIM measurement can be used to estimate the maximum stimulation level on other positioning. The algorithm can also recommend electrode / channel deactivation. Again, the diagnostic tool can include an unintentional facial nerve stimulation thresholding procedure in which the minimum stimulation level that causes unintentional facial nerve stimulation is determined, and once this threshold is known, the maximum stimulation level on other electrodes can also be estimated (e.g., using a ladder network model). This algorithm can also optimize a second parameter, such as rate, pulse width, and / or pulse shape. However, it should be noted that in practice the effectiveness of parameter adjustments may be somewhat limited (e.g., in some instances, optimizing rate, pulse width, and / or pulse shape may only help mild cases of unintentional facial nerve stimulation).

[0095] Figure 7 is a flow chart illustrating an exemplary method 700 for postoperative audiological management using a postoperative recommendation algorithm [ALGO4] to diagnose and recommend treatment for unintentional facial nerve stimulation. Figure 7 The method 700 begins with a step involving implanting a stimulation assembly into the inner ear of a recipient. Figure 7 ), wherein the stimulation assembly is a component of a medical device configured to deliver electrical stimulation signals to the inner ear. For example, step S710 may include the following sub-steps: determining a transimpedance matrix (TIM) of the stimulation assembly within the inner ear using the electrical values ​​(captured voltages) (S714). Using a computing device (e.g., Figures 1A-1DThe method 700 further includes determining, based on the electrical values, that the recipient has an elevated risk of unintentional facial nerve stimulation from one or more identified electrodes of the stimulation assembly (S720). For example, step S720 may include the following sub-steps: analyzing the electrical values ​​(e.g., voltage, current, TIM) to estimate one or more locations where current flows out of the inner ear (S722). In addition, the method 700 may include using a computing device to output a recommendation for setting at least one channel configuration for one or more identified electrodes to be used by the medical device when delivering electrical stimulation to the inner ear via the stimulation assembly to remedy the elevated risk of unintentional facial nerve stimulation from one or more identified electrodes (S730). For example, this information may indicate the location of potential electrodes that have an elevated risk of causing unintentional facial nerve stimulation from within the inner ear. In addition, method 700 may include estimating the maximum stimulation level on each electrode of the stimulation assembly using a computing device (S740), wherein the recommendation output at step S730 may be determined based on these estimated values. In some exemplary embodiments, step S730 may include the following sub-steps: based on the estimated maximum stimulation level output for each electrode of the stimulation assembly, a recommendation to reduce the stimulation level of at least one of the one or more identified electrodes to a level below the upper limit to remedy the increased risk of unintentional facial nerve stimulation (S742). In some other exemplary embodiments, step S730 may include the following sub-steps: based on the estimated maximum stimulation level output for each electrode of the stimulation assembly, a recommendation to deactivate at least one of the one or more identified electrodes to remedy the increased risk of unintentional facial nerve stimulation (S744).

[0096] Therefore, in the above and combined Figure 7 The postoperative recommendation algorithm (ALGO4) described in method 700 builds on the diagnostic algorithm (ALGO3), where the method involves map creation to support treatment. In some exemplary embodiments, this recommendation algorithm can recommend unipolar map optimization (e.g., reconfiguring channels to limit levels, and / or deactivating certain channels / electrodes).

[0097] (Treatment ALGO5) The second option is to reconfigure the stimulation channels to avoid any current flow along the labyrinthine segment of the FN. In this exemplary embodiment, the electronic platform will determine the intervention options and automatically implement the recommended treatment options. For some stimulation components, the options are bipolar channels and common ground channels. In these methods, all current from within the cochlea is recycled. These stimulation modes will require higher stimulation levels to excite the auditory nerve and consume battery, but will avoid facial perception of unintentional facial nerve stimulation. An algorithm can help the audiologist select these channels.

[0098] Fig. 8A is a flow chart illustrating an exemplary method 800 for post-operative audiological management using a post-operative treatment algorithm (ALGO5) to diagnose and automatically treat unintentional facial nerve irritation. Fig. 8A The method 800 begins with a step involving implanting a stimulation assembly into the inner ear of a recipient. Fig. 8A ), wherein the stimulation assembly is a component of a medical device configured to deliver electrical stimulation signals to the inner ear. For example, step S810 may include the following sub-steps: determining a transimpedance matrix (TIM) of the stimulation assembly within the inner ear using the electrical values ​​(captured voltages) (S814). Using a computing device (e.g., Figures 1A-1DThe method 800 further includes determining, based on the electrical values, that the recipient has an elevated risk of unintentional facial nerve stimulation from one or more identified electrodes of the stimulation assembly (S820). For example, step S820 may include the following sub-steps: analyzing the electrical values ​​(e.g., voltage, current, TIM) to estimate one or more locations where current flows out of the inner ear (S722). In addition, the method 800 may include using a computing device to set at least one channel configuration of one or more identified electrodes for use by the medical device when delivering electrical stimulation to the inner ear via the stimulation assembly to remedy the elevated risk of unintentional facial nerve stimulation from the one or more identified electrodes (S830). For example, step S830 may also include the following sub-steps: determining the amount of current outflow from one or more identified electrodes toward the facial nerve when electrical stimulation is delivered by the medical device via at least one other electrode of the stimulation component (S832), and configuring the medical device to actively absorb a first current amount corresponding to the amount of current outflow from one or more identified electrodes when electrical stimulation is delivered via at least one other electrode of the stimulation component (S834).

[0099] In the above and combined Fig. 8A The postoperative treatment algorithm (ALGO5) described in method 800 also builds on the diagnostic algorithm (ALGO3) and the recommendation algorithm (ALGO4), wherein the method involves recommending optimal changes to the spatial channel definition that keep the (monopolar) current away from the facial nerve canal, and automatically implementing these optimal changes based on its recommendations. The new channel definition can depend on the capabilities of the chipset, the analysis of the electric field within the cochlea, and in the case of simple circuits (e.g., CIC4) it can be recommended to change from monopolar to bipolar or all poles (common ground). However, the new channel definition can also be more advanced and personalized based on a precise analysis of the TIM measurements.

[0100] The multipolar capability of some implants provides a better option for redefining channels. Bipolar and common ground configurations have significant disadvantages that battery life will be compromised. Another approach would involve gently modifying the monopolar channel, just enough to avoid unintentional facial nerve stimulation. Mathematical analysis estimates the intensity of the current outflow flux near the recording electrode for a certain influx at the stimulating electrode. Assume that when EL20 is stimulated, 8% of the current will flow out of the cochlea near EL10, and EL10 will be an unintentional facial nerve stimulation trigger. In this case, the method may be to actively absorb 8% of the current passing through EL10 when EL20 is stimulated. Instead of the current obeying Ohm's law and flowing out of the cochlea through a high conductive path near EL10, EL10 will actively force 8% of the current to return through the electrode. This technology should avoid unintentional facial nerve stimulation while minimizing interference with the normal intracochlear field of the monopolar stimulation at EL20. Therefore, an algorithm can be designed that uses TIM information to redefine the channel, adjusting them to quasi-monopolar channels (partial bipolar channels) to avoid unintentional facial nerve stimulation. Figure 8B This situation is shown.

[0101] Figure 8B It is shown that the postoperative treatment algorithm (ALGO5) and Fig. 8A The method 800 modifies each monopolar field to actively absorb the field through the identified electrode (e.g., Figure 8B Figure 1 is a graphical view of an example of some currents at EL14 in the cochlea, where the percentage of current actively absorbed by the intracochlear electrode matches the passive conduction through the facial nerve canal. At EL14, a certain percentage of the current is actively absorbed, driving the intracochlear voltage to zero. In this way, the intracochlear current has no motivation to take the facial nerve canal route to leave the cochlea.

[0102] Therefore, in the above and combined Fig. 8A The post-operative treatment algorithm (ALGO5) described in method 800 can adjust the spatial channel definition to avoid unintentional facial nerve stimulation (e.g., quasi-monopolar to avoid current flow along the facial nerve). This may be an independent idea that may not be related to any objective metrics of the other algorithms and methods described above. This automated solution focuses on a novel multipolar approach that is specifically designed to keep current away from the facial nerve canal in order to treat unintentional facial nerve stimulation.

[0103] In short, combined Figure 3 , 4 The above disclosures of , 5, 6, 7, 8A and 8B respectively describe five algorithmic methods (methods 300, 400, 600, 700, 800) to holistically manage unintentional non-auditory nerve stimulation (e.g., unintentional facial nerve stimulation):

[0104] (1) The first element (preoperative ALGO1, Figure 3 Method 300) is an unintentional facial nerve stimulation estimator for preoperative situations where CT or MRI images are available. A segmentation algorithm tracks the facial nerve canal and the first cochlear turn, then calculates the closest geometric distance to the basal gyrus (and possibly the electrical distance by taking into account bone density). This information is presented to the expert surgeon so that they can adjust electrode selection, surgical technique, and electrode positioning.

[0105] (2) The second element (intraoperative ALGO2, Figure 4 Method 400) is a transimpedance matrix (TIM) based diagnosis. While the surgeon and recipient are still in the operating room, TIM measurements are performed, and the intelligent agent analyzes the TIM data to determine whether a third current absorption occurs. If a third current absorption is found, its intensity and range can be determined. The purpose is to notify the surgeon in the OR for surgical intervention (e.g., repositioning the electrode).

[0106] (3) The third element (postoperative diagnosis ALGO3, Figure 6 Method 600) is a diagnosis during the first fitting, helping the audiologist locate the facial nerve (in terms of electrodes), and possibly informing the audiologist of the possible locations of the most sensitive electrodes / channels that may cause unintentional facial nerve stimulation. This diagnostic algorithm can be guided by existing knowledge from operating room analysis (e.g., captured via intraoperative ALGO2), if available. The diagnostic tool can help the practitioner deal with this complex case. Alternatively, a variation of ALGO1 can be used so that it can be analyzed geometrically at this time with the help of postoperative CT. In other words, although ALGO1 is described above only as preoperative (the stimulation component has not yet been inserted), it is recognized that ALGO1 can also or alternatively be used as part of intraoperative analysis or even postoperative analysis.

[0107] (4) The fourth element (ALGO4 is recommended after surgery. Figure 7 The method 700) further builds on previous diagnostic tools (e.g., Diagnostic ALGO3) by also supporting treatment (map creation). The algorithm can recommend unipolar map optimization (limit level or deactivation).

[0108] (5) Fifth Element (postoperative treatment ALGO5, Fig. 8A Method 800) again provides a treatment recommendation algorithm. Building further on previous ideas, the recommendation algorithm suggests optimal changes to the spatial channel definitions with the goal of keeping current away from the FN. The new channel definitions depend on the capabilities of the chipset, the analysis of the electric fields within the cochlea, and may suggest a change from monopolar to bipolar or all poles (common ground) in the case of a simpler implantable receiver / stimulator, or may be more advanced and personalized based on a precise analysis of the TIM (e.g., on a receiver / stimulator with multipolar capabilities).

[0109] It is to be appreciated that the above examples are merely illustrative and that the various techniques are not mutually exclusive. For example, in an exemplary surgical use case, a combination of ALGO1 and ALGO2 may be used to obtain improved results. The ALGO1+ALGO2 approach will combine anatomical knowledge (imaging) and electrical measurements (TIM) to make the FNS risk assessment more accurate (higher sensitivity + specificity). If ALGO1+ALGO2 points in the direction of a certain FNS risk, then the two algorithms reinforce each other and vice versa.

[0110] As described above, certain aspects are described as "pre-operative," "intra-operative," or "post-operative." These descriptions are for ease of explanation only and do not limit any one technique (e.g., algorithm) to any particular time, order, etc. That is, in some examples, a technique described as pre-operative may be implemented as an intra-operative procedure or a post-operative procedure; a technique described as intra-operative may be implemented as a pre-operative procedure or a post-operative procedure; and a technique described as post-operative may be implemented as an intra-operative procedure or a pre-operative procedure.

[0111] All of the above approaches are consistent with the vision, whereby in their simplest form, these algorithms inform the clinician to provide a new piece of diagnostic information, and nothing more. In this first stage, the clinician then decides on a further course of action (Human-in-the-loop). In the next stage, the algorithm not only provides new diagnostic information, but also recommends a certain course of action that the practitioner can accept or reject (Human-on-the-loop). The model is more powerful because it can be used by a larger group of clinicians because the need for expertise is reduced. In order to reach this second stage, more clinical evidence may be needed to support the recommendation. Finally, the third stage is a fully automated stage, in which the unintentional facial nerve stimulation prediction / detection algorithm makes the decision to deactivate or reconfigure the channel without the involvement of a practitioner (human-out-of-the-loop). This automatic situation will be required in a 100% self-care clinical model. However, for the foreseeable future, the management of complex cases such as unintentional facial nerve stimulation will generally be performed by practitioners (assisted guidance provided by the unintentional facial nerve stimulation prediction / detection algorithm).

[0112] The techniques described above may provide one or more benefits and advantages over existing techniques, including, but not limited to: providing better hearing outcomes for affected recipients, reducing the need for re-implantation, reducing complication rates for surgeons, enabling audiologists to perform their work faster and achieve better outcomes, and reducing the number of bad surgeries. Clinicians would benefit from some guidance and audiological programming based on objective metrics during surgery. Likewise, given that the cochlea may change over time due to certain chronic conditions (e.g., otosclerosis), such that a recipient may develop unintentional facial nerve stimulation years after an initial implant, techniques that can help avoid or reduce the need for re-implantation would be of significant value.

[0113] As previously noted, for illustrative purposes, the technology presented herein is primarily described with reference to cochlear implant systems and with reference to specific types of unintentional stimulation or stimulation side effects (i.e., unintentional facial nerve stimulation). However, as also mentioned above, it is to be appreciated that the technology presented herein may also be partially or fully implemented by other types of implantable medical devices for managing different types of unintentional stimulation and / or stimulation side effects. That is, various aspects of the technology presented herein may be applied in other fields (e.g., deep brain stimulators that are also prone to generating stimulation side effects) as well as in neuromodulation applications where nearby nerves penetrate bone channels and stimulation may be wider (e.g., spinal cord stimulators, pelvic stimulators, stimulation devices for treating migraines, etc.).

[0114] Below is Figure 9-11 Several exemplary devices that may benefit from the techniques disclosed herein are described in more detail in . For example, the techniques described herein may be used to prioritize clinician tasks associated with configuring operating parameters of a wearable medical device, such as a wearable medical device such as a Fig. 9 An implantable stimulation system as described in Fig.10 The vestibular stimulator described in or Fig.11 As described elsewhere herein, these devices are merely illustrative, and the technology of the present disclosure may be applied to other medical devices, such as neurostimulators, pacemakers, defibrillators, sleep apnea management stimulators, epilepsy treatment stimulators, tinnitus management stimulators, and vestibular stimulation devices, spinal cord stimulation, deep brain stimulators, pelvic stimulators, stimulation devices for treating migraine, and other medical devices that deliver stimulation to tissue.

[0115] Fig. 9is a functional block diagram of an implantable stimulator system 900 that can benefit from the technology described herein. The implantable stimulator system 900 includes a wearable device 100 that acts as an external processor device and an implantable device 30 that acts as an implanted stimulator device. In an example, the implantable device 30 is an implantable stimulator device that is configured to be implanted below the tissue (e.g., skin) of the recipient. In an example, the implantable device 30 includes a biocompatible implantable housing 902. Here, the wearable device 100 is configured to be percutaneously connected to the implantable device 30 via a wireless connection to provide additional functionality to the implantable device 30.

[0116] In the example shown, the wearable device 100 includes one or more sensors 912, a processor 914, a transceiver 918, and a power supply 948. The one or more sensors 912 may be one or more units configured to generate data based on sensed activity. In the example where the stimulation system 900 is a hearing prosthesis system, the one or more sensors 912 include a sound input sensor, such as a microphone, an electrical input for an FM hearing system, other components for receiving sound input, or a combination thereof. In the case where the stimulation system 900 is a visual prosthesis system, the one or more sensors 912 may include one or more cameras or other visual sensors. In the case where the stimulation system 900 is a cardiac stimulator, the one or more sensors 912 may include a cardiac monitor. The processor 914 may be a component (e.g., a central processing unit) configured to control the stimulation provided by the implantable device 30. The stimulation may be controlled based on data from the sensor 912, a stimulation schedule, or other data. In the case where the stimulation system 900 is a hearing prosthesis, the processor 914 may be configured to convert a sound signal received from (one or more) sensors 912 (e.g., acting as a sound input unit) into a signal 951. The transceiver 918 is configured to transmit a signal 951 in the form of a power signal, a data signal, a combination thereof (e.g., by interleaving the signal), or other signal. The transceiver 918 may also be configured to receive power or data. The stimulation signal may be generated by the processor 914 and transmitted to the implantable device 30 using the transceiver 918 for providing stimulation.

[0117] In the example shown, implantable device 30 includes transceiver 918, power source 948, and medical device 911 including electronics module 910 and stimulator assembly 930. Implantable device 30 also includes a hermetically sealed biocompatible implantable housing 902 that encloses one or more of the components.

[0118] The electronic module 910 may include one or more other components to provide medical device functions. In many examples, the electronic module 910 includes one or more components for receiving a signal and converting the signal into a stimulation signal 915. The electronic module 910 may also include a stimulator unit. The electronic module 910 can generate a stimulation signal 915 or control the delivery of the stimulation signal to the stimulator assembly 930. In an example, the electronic module 910 includes one or more processors (e.g., a central processing unit or a microcontroller) connected to a memory component (e.g., a flash memory), and the memory component stores instructions that, when executed, cause the execution of an operation. In an example, the electronic module 910 generates and monitors parameters (e.g., output voltage, output current, or line impedance) associated with generating and delivering stimulation. In an example, the electronic module 910 generates a telemetry signal (e.g., a data signal) including telemetry data. The electronic module 910 can send a telemetry signal to the wearable device 100 or store the telemetry signal in a memory for later use or retrieval.

[0119] The stimulator assembly 930 can be a component configured to provide stimulation to the target tissue. In the example shown, the stimulator assembly 930 is an electrode assembly, which includes an electrode contact array arranged on a lead. The lead can be arranged near the tissue to be stimulated. In the case where the system 900 is a cochlear implant system, the stimulator assembly 930 can be inserted into the cochlea of ​​the recipient. The stimulator assembly 930 can be configured to deliver the stimulation signal 915 (e.g., electrical stimulation signal) generated by the electronic module 910 to the cochlea so that the recipient experiences hearing perception. In other examples, the stimulator assembly 930 is a vibration actuator, which is arranged inside or outside the housing of the implantable device 30 and is configured to generate vibration. The vibration actuator receives the stimulation signal 915 and generates a mechanical output force in the form of vibration based on the stimulation signal. The actuator can deliver vibration to the recipient's skull in a manner that generates movement or vibration of the recipient's skull, thereby generating hearing perception by activating the hair cells in the recipient's cochlea via cochlear fluid movement.

[0120] The transceiver 918 may be a component configured to transcutaneously receive and / or transmit a signal 951 (e.g., a power signal and / or a data signal). The transceiver 918 may be a collection of one or more components that form part of a transcutaneous energy or data transmission system to transmit a signal 951 between the wearable device 100 and the implantable device 30. Various types of signal transmission, such as electromagnetic, capacitive, and inductive transmission, may be used to effectively receive or transmit the signal 951. The transceiver 918 may include a coil 20 or be electrically connected to a coil.

[0121] As shown, the wearable device 100 includes a coil 209 for transcutaneously transmitting signals with the concave coil 20. As described above, transcutaneously transmitting signals between the coil 209 and the coil 20 may include transmitting power and / or data from the coil 209 to the coil 20 and / or transmitting data from the coil 20 to the coil 209. The power supply 948 may be one or more components configured to provide operating power to other components. The power supply 948 may be or include one or more rechargeable batteries. The power of the battery can be received from the power supply and stored in the battery. The power can then be distributed to other components for operation as needed.

[0122] It should be understood that although combined Fig. 9 Although specific components are described, the technology disclosed herein can be applied to any of a variety of situations. The above discussion is not intended to indicate that the disclosed technology is only suitable for use in applications similar to those in Fig. 9 In general, the methods and systems herein may be practiced using additional configurations and / or some aspects described may be excluded without departing from the methods and systems disclosed herein.

[0123] Fig.10 An exemplary vestibular stimulator system 1002 is shown, which can be used to implement the embodiments presented herein. As shown, the vestibular stimulator system 1002 includes an implantable component (vestibular stimulator) 1012 and an external device / component 1004 (e.g., an external processing device, a battery charger, a remote controller, etc.). The external device 1004 includes a transceiver unit 2070. Thus, the external device 1004 is configured to transmit data (and possibly power) to the vestibular stimulator 1012.

[0124] The vestibular stimulator 1012 includes an implant body (main module) 1034, a lead region 1036, and a stimulation assembly 1016, all configured to be implanted beneath the skin / tissue (tissue) 1015 of a recipient. The implant body 1034 generally includes an airtight sealed housing 1038 in which an RF interface circuit system, one or more rechargeable batteries, one or more processors, and a stimulator unit are disposed. The implant body 1034 also includes an internal / implantable coil 1014, which is generally external to the housing 1038 but connected to a transceiver via an airtight feedthrough (not shown).

[0125] The stimulation assembly 1016 includes a plurality of electrodes 2054(1)-(3) disposed in a carrier member (e.g., a flexible silicone body). In this particular example, the stimulation assembly 1016 includes three (3) stimulation electrodes, referred to as stimulation electrodes 2054(1), 2054(2), and 2054(3). The stimulation electrodes 2054(1), 2054(2), and 2054(3) serve as an electrical interface for delivering electrical stimulation signals to the vestibular system of a recipient.

[0126] The stimulation assembly 1016 is configured so that a surgeon can implant the stimulation assembly near the recipient's otolith organ via, for example, the recipient's oval window. It should be understood that this particular embodiment with three stimulation electrodes is merely illustrative, and the techniques presented herein can be used with stimulation assemblies with different numbers of stimulation electrodes, stimulation assemblies with different lengths, etc.

[0127] In operation, the vestibular stimulator 1012, the external device 1004, and / or another external device can be configured to implement the techniques presented herein. That is, the vestibular stimulator 1012, possibly in combination with the external device 1004 and / or another external device, can include an induced bio-response analysis system as described elsewhere herein.

[0128] Fig.11 A retinal prosthesis system 2111 is shown, which includes an external device 2111 (which may correspond to the wearable device 100) configured to communicate with a retinal prosthesis 2110 via a signal 1151. The retinal prosthesis 2110 includes an implant processing module 2135 (e.g., which may correspond to the implantable device 30), and a retinal prosthesis sensor stimulator 1190 is positioned proximate to the recipient's retina. The external device 2111 and the processing module 2135 may communicate via the coils 209, 20.

[0129] In an example, sensory input (e.g., photons entering the eye) is absorbed by a microelectronic array of a sensor-stimulator 1190 that is hybridized with a glass piece 1192 that includes, for example, an embedded microwire array. The glass may have a curved surface that conforms to the inner radius of the retina. The sensor-stimulator 1190 may include a microelectronic imaging device that may be made of thin silicon containing an integrated circuit system that converts incident photons into electronic charges.

[0130] The processing module 2135 includes an image processor 2133 that communicates with the sensor-stimulator 1190 signals via, for example, leads 2198 extending through a surgical incision 2199 formed in the eye wall. In other examples, the processing module 2135 communicates with the sensor-stimulator 1190 wirelessly. The image processor 2133 processes the input of the sensor-stimulator 1190 and provides control signals back to the sensor-stimulator 1190 so that the device can provide an output to the optic nerve. That is, in an alternative example, the processing is performed by a component adjacent to or integrated with the sensor-stimulator 1190. The charge generated by the conversion of the incident photons is converted into a proportional amount of electronic current, which is input to the nearby retinal cell layer. The cells are excited, and signals are sent to the optic nerve, thereby inducing visual perception.

[0131] The processing module 2135 may be implanted in the recipient and function by communicating with an external device 2111, such as a behind-the-ear unit, a pair of glasses, etc. The external device 2111 may include an external light / image capture device (e.g., located in / on a behind-the-ear unit or a pair of glasses, etc.), while as noted above, in some examples, the light / image is captured by the sensor-stimulator 1190, which is implanted in the recipient.

[0132] It should be understood that although specific uses of the present technology have been illustrated and discussed above, the disclosed technology can be used with various devices according to many examples of the present technology. The above discussion is not intended to indicate that the disclosed technology is only suitable for implementation in systems similar to those shown in the accompanying drawings. In general, additional configurations can be used to practice the processes and systems herein, and / or some aspects described can be excluded without departing from the processes and systems disclosed herein.

[0133] The present disclosure describes some aspects of the present invention technology with reference to the accompanying drawings, in which only some possible aspects are shown. However, other aspects may be embodied in many different forms and should not be construed as being limited to the aspects set forth herein. Instead, these aspects are provided to make the present disclosure detailed and complete and to fully convey the scope of possible aspects to those skilled in the art.

[0134] It should be understood that the various aspects (e.g., parts, components, etc.) described herein with respect to the figures are not intended to limit the systems and processes to the specific aspects described. Therefore, additional configurations can be used to practice the methods and systems herein, and / or some aspects described can be excluded without departing from the methods and systems disclosed herein.

[0135] According to certain aspects, a system and a non-transitory computer-readable storage medium are provided. The system is configured with hardware configured to perform operations similar to the method of the present disclosure. One or more non-transitory computer-readable storage media include instructions that, when executed by one or more processors, cause the one or more processors to perform operations similar to the method of the present disclosure.

[0136] Similarly, where steps of a process are disclosed, these steps are described for the purpose of illustrating the present methods and systems, and are not intended to limit the present disclosure to a particular sequence of steps. For example, the steps may be performed in a different order, two or more steps may be performed simultaneously, additional steps may be performed, and disclosed steps may be eliminated without departing from the present disclosure. Furthermore, the disclosed processes may be repeated.

[0137] Although specific aspects are described herein, the scope of the present technology is not limited to these specific aspects. Those skilled in the art will recognize other aspects or improvements within the scope of the present technology. Therefore, specific structures, actions or media are disclosed only as illustrative aspects. The scope of the present technology is limited by the attached claims and any equivalents therein.

[0138] It should also be understood that the embodiments presented herein are not mutually exclusive and that various embodiments can be combined with another embodiment in any of a variety of different ways.

Claims

1. A method comprising: Obtain preoperative images of the recipient's inner ear; analyzing the pre-operative images using a computing device to determine a risk of unintentional facial nerve stimulation associated with inserting a stimulation assembly into the inner ear; and Information regarding the risk of unintentional facial nerve stimulation associated with inserting the stimulation assembly into the inner ear is output using the computing device.

2. The method according to claim 1, further comprising: obtaining a post-operative image of the inner ear of the recipient; as well as The pre-operative images and the post-operative images are analyzed using the computing device to determine a risk of unintentional facial nerve stimulation associated with inserting the stimulation assembly into the inner ear.

3. The method of claim 1 , wherein obtaining a preoperative image of the inner ear of the cochlear implant recipient comprises: A pre-operative magnetic resonance imaging (MRI) scan of the inner ear of the recipient is obtained.

4. The method of claim 1 , 2 or 3, wherein analyzing the pre-operative images to determine the risk of unintentional facial nerve stimulation associated with inserting the stimulation assembly into the inner ear comprises: The preoperative images were analyzed to determine if cochleo-facial dehiscence was present.

5. The method of claim 4, wherein outputting information about the risk of unintentional facial nerve stimulation associated with inserting the stimulation assembly into the inner ear comprises: Information characterizing the cochleo-facial cleft is output.

6. The method of claim 1 , 2 or 3, wherein analyzing the pre-operative images to determine the risk of unintentional facial nerve stimulation associated with inserting the stimulation assembly into the inner ear comprises: The pre-operative images are analyzed using a segmentation process to determine the closest distance between the recipient's facial nerve canal and the basal gyrus of the inner ear.

7. The method according to claim 6, further comprising: determining that the closest distance between the facial nerve canal and the basal gyrus of the inner ear of the recipient is less than a threshold distance, and Wherein outputting information regarding the risk of unintentional facial nerve stimulation associated with inserting the stimulation assembly into the inner ear comprises: A warning output is generated indicating that the recipient is at risk for unintentional facial nerve stimulation after inserting the stimulation assembly into the inner ear.

8. The method of claim 7, wherein the risk of unintentional facial nerve stimulation is based at least in part on mechanical properties of the stimulation component.

9. The method of claim 7, wherein the risk of unintentional facial nerve stimulation is based at least in part on a selected technique for inserting the stimulation assembly into the inner ear.

10. The method of claim 7, wherein the warning output includes a probability of unintentional facial nerve stimulation and an estimate of a location within the inner ear where the unintentional facial nerve stimulation may occur according to insertion angle.

11. The method of claim 4, wherein outputting information regarding the risk of unintentional facial nerve stimulation associated with inserting the stimulation assembly into the inner ear comprises: A recommendation is output for a type of stimulation component that mitigates the risk of unintentional facial nerve stimulation.

12. The method of claim 1, 2 or 3, after at least partially inserting the stimulation assembly into the inner ear, further comprising: performing a plurality of electrical measurements via electrodes of the stimulation assembly to obtain a plurality of electrical parameters of positioning of the stimulation assembly within the inner ear; as well as The plurality of electrical parameters are analyzed to identify a risk of unintentional facial nerve stimulation associated with the positioning of the stimulation assembly within the inner ear.

13. A method comprising: after at least partially inserting the stimulation assembly into the inner ear of the recipient; performing a plurality of electrical measurements via electrodes of the stimulation assembly to obtain a plurality of electrical parameters of positioning of the stimulation assembly within the inner ear; as well as At a computing device, the plurality of electrical parameters are analyzed to identify a risk of unintentional stimulation associated with the positioning of the stimulation component within the inner ear.

14. The method of claim 13, wherein performing a plurality of electrical measurements via the electrodes of the stimulation assembly comprises: A plurality of voltage measurements are performed to capture a plurality of voltages within the inner ear.

15. The method according to claim 14, further comprising: At least one transimpedance matrix for the positioning of the stimulation assembly within the inner ear is determined using a plurality of voltage measurements.

16. The method of claim 13, 14 or 15, wherein analyzing the plurality of electrical parameters to identify a risk of unintentional stimulation associated with the positioning of the stimulation component within the inner ear comprises: The plurality of electrical parameters are analyzed to estimate one or more locations of electrical current egress from the inner ear at the location of the stimulation assembly within the inner ear.

17. The method according to claim 13, 14 or 15, further comprising: Information regarding the risk of unintentional stimulation associated with the positioning of the stimulation component within the inner ear is output using the computing device.

18. The method of claim 17, wherein the information about the risk of unintentional stimulation includes locations of potential electrodes having an increased risk of causing unintentional stimulation from within the inner ear.

19. The method of claim 13, 14 or 15, further comprising: determining that the positioning of the stimulation component within the inner ear is associated with an increased risk of unintentional stimulation; as well as A recommendation for surgical intervention to reposition the stimulation assembly within the inner ear is output.

20. The method of claim 13, 14 or 15, further comprising: determining that the positioning of the stimulation component within the inner ear is associated with an increased risk of unintentional stimulation; as well as A recommendation is output to insert a different type of stimulation assembly into the inner ear to mitigate the risk of unintentional stimulation.

21. The method of claim 13, 14 or 15, wherein analyzing the plurality of electrical parameters to identify a risk of unintentional stimulation associated with the positioning of the stimulation component within the inner ear comprises: The plurality of electrical parameters are analyzed to estimate a risk of unintentional non-auditory stimulation associated with the positioning of the stimulation component within the inner ear.

22. The method of claim 13, 14 or 15, wherein analyzing the plurality of electrical parameters to identify a risk of unintentional stimulation associated with the positioning of the stimulation component within the inner ear comprises: The plurality of electrical parameters are analyzed to estimate a risk of unintentional facial nerve stimulation associated with the positioning of the stimulation assembly within the inner ear.

23. A method comprising: capturing a plurality of electrical values ​​via electrodes of a stimulation assembly implanted in an inner ear of a recipient, wherein the stimulation assembly is a component of a medical device configured to deliver electrical stimulation signals to the inner ear; determining, based on the plurality of electrical values, that the recipient has an elevated risk of unintentional facial nerve stimulation from at least one identified electrode of the stimulation assembly; as well as At least one electrode channel configuration is provided for use by the medical device in delivering electrical stimulation to the inner ear via the stimulation assembly to remediate the elevated risk of unintentional facial nerve stimulation from the at least one identified electrode.

24. The method of claim 23, wherein setting at least one electrode channel configuration for use by the medical device in delivering electrical stimulation to the inner ear via the stimulation assembly to remedy the elevated risk of unintentional facial nerve stimulation from at least one electrode comprises: determining an amount of current outflow from the at least one electrode toward the facial nerve when electrical stimulation is delivered by the medical device via at least one other electrode of the stimulation assembly; as well as The medical device is configured to actively sink a first amount of current associated with the current outflow from the at least one identified electrode toward the facial nerve while delivering electrical stimulation via the at least one other electrode of the stimulation assembly.

25. The method of claim 24, wherein the first amount of current comprises at least 50% of the current flowing from the at least one identified electrode toward the facial nerve.

26. The method of claim 25, wherein the first amount of current comprises at least 70% of the current flowing from the at least one identified electrode toward the facial nerve.

27. The method of claim 23, 24, 25 or 26, wherein capturing a plurality of electrical values ​​via the electrodes of the stimulation assembly comprises: A plurality of voltage measurements are performed to capture a plurality of voltages within the inner ear.

28. The method of claim 26, further comprising: At least one transimpedance matrix of the stimulation assembly within the inner ear is determined using the plurality of voltage measurements.

29. The method of claim 23, 24, 25, or 26, wherein determining that the recipient has an elevated risk of unintentional facial nerve stimulation from at least one electrode of the stimulation assembly based on the plurality of electrical values ​​comprises: The plurality of electrical values ​​are analyzed to estimate one or more locations from which electrical current from the inner ear is emanating.

30. One or more non-transitory computer-readable storage media comprising instructions that, when executed by a processor, cause the processor to: obtaining a plurality of electrical values ​​captured via electrodes of a stimulation assembly implanted in an inner ear of a recipient, wherein the stimulation assembly is a component of a medical device configured to deliver electrical stimulation signals to the inner ear; determining, based on the plurality of electrical values, that the recipient has an elevated risk of a stimulation side effect from at least one identified electrode of the stimulation assembly; and A recommendation is output for setting at least one electrode channel configuration for use by the medical device in delivering electrical stimulation to the inner ear via the stimulation assembly to remedy the elevated risk of stimulation side effects from the at least one identified electrode.

31. The one or more non-transitory computer-readable storage media of claim 30, wherein the instructions executable to capture a plurality of electrical values ​​via the electrodes of the stimulation component comprise instructions operable to: A plurality of voltage measurements representing a plurality of voltages within the inner ear are obtained.

32. The one or more non-transitory computer-readable storage media of claim 31 , further comprising instructions executable to: At least one transimpedance matrix of the stimulation assembly within the inner ear is determined using the plurality of voltage measurements.

33. One or more non-transitory computer-readable storage media according to claim 30, 31 or 32, wherein the instructions executable to determine that the recipient has an elevated risk of stimulation side effects from at least one identified electrode of the stimulation assembly based on the plurality of electrical values ​​include instructions executable to: The plurality of electrical values ​​are analyzed to estimate one or more locations from which electrical current from the inner ear is emanating.

34. The one or more non-transitory computer-readable storage media of claim 30, 31, or 32, further comprising instructions executable to: Estimate the maximum stimulation level on each channel of the stimulation component.

35. The one or more non-transitory computer-readable storage media of claim 34, wherein the instructions executable to output a recommendation for setting at least one electrode channel configuration include instructions executable to: A recommendation is output to reduce the stimulation level of the at least one identified electrode below an upper limit to remedy the elevated risk of stimulation side effects from the at least one identified electrode.

36. The one or more non-transitory computer-readable storage media of claim 34, wherein the instructions executable to output a recommendation for setting at least one electrode channel configuration include instructions executable to: A recommendation is output to deactivate the at least one identified channel to remedy the elevated risk of a stimulation side effect from the at least one identified channel.

37. The one or more non-transitory computer-readable storage media of claim 30, 31, or 32, wherein the instructions executable to determine, based on the plurality of electrical values, that the recipient has an elevated risk of stimulation side effects from at least one identified electrode of the stimulation assembly comprises instructions executable to: The plurality of electrical values ​​are analyzed to estimate a risk of non-auditory stimulation from at least one identified electrode.

38. The one or more non-transitory computer-readable storage media of claim 30, 31, or 32, wherein analyzing the plurality of electrical parameters to identify a risk of unintentional stimulation associated with the positioning of the stimulation assembly within the inner ear comprises: The plurality of electrical values ​​are analyzed to estimate a risk of facial nerve stimulation from at least one identified electrode.

39. An apparatus comprising: an input device configured to obtain a plurality of electrical measurements captured via electrodes of a stimulation assembly positioned in an inner ear of a recipient; as well as At least one processor is configured to analyze the plurality of electrical measurements and output an indication of a risk of unintentional non-auditory stimulation associated with the positioning of the stimulation component within the inner ear.

40. The apparatus of claim 39, wherein the plurality of electrical measurements comprises a plurality of voltage measurements.

41. The device of claim 40, wherein the at least one processor is configured to determine at least one transimpedance matrix for the positioning of the stimulation assembly within the inner ear using the plurality of voltage measurements.

42. The apparatus of claim 39, 40 or 41, wherein the at least one processor is configured to analyze the plurality of electrical measurements to estimate one or more locations of electrical current outflow from the inner ear at the positioning of the stimulation component within the inner ear.

43. Apparatus according to claim 39, 40 or 41, wherein the indication of risk of unintentional non-auditory stimulation comprises the location of potential pathways having an increased risk of causing unintentional non-auditory stimulation from within the inner ear.

44. The apparatus of claim 39, 40 or 41, wherein the at least one processor is configured to output a recommendation for surgical intervention to reposition the stimulation assembly within the inner ear.

45. The apparatus of claim 39, 40 or 41, wherein the at least one processor is configured to output a recommendation to insert a different type of stimulation assembly into the inner ear to mitigate the risk of unintentional non-auditory stimulation.

46. ​​A system comprising: a medical device comprising a plurality of electrodes configured to be inserted into a recipient; as well as A computing device, the computing device comprising: an input device in communication with the implantable medical device and configured to receive intraoperative measurements performed via one or more of the plurality of electrodes, and One or more processors configured to estimate a risk of a stimulation side effect from at least one electrode of the plurality of electrodes using the intraoperative measurements and to adjust operation of the medical device to remedy the risk of the stimulation side effect.

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