Patent Description:
The types of medical devices and the ranges of functions performed thereby have increased over the years. For example, many medical devices, sometimes referred to as "implantable medical devices," now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease/injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and/or data received from external devices that are part of, or operate in conjunction with, implantable components. <CIT> discloses an apparatus and method for triggering nerve-action potentials in each of a plurality of cochlear neurons in a cochlea of a person and in each one of a plurality of vestibular neurons in a vestibular organ of a person. A vestibular implant portion of the apparatus includes stimulation sources including a plurality of vertical-cavity-surface-emitting lasers and/or a plurality of electrodes. A transmission medium configured to deliver light signals to a vestibular neuron can include a plurality of optical fibers. The light signals can be used to optically trigger nerve-action potentials.

An apparatus according to the invention includes the features defined in claim <NUM>.

Embodiments include the features defined in the dependent claims.

Embodiments of the present invention are described herein in conjunction with the accompanying drawings, in which:.

Sensory impulses relating to balance and spatial orientation are generated by the vestibular system. These sensory impulses are perceived by the brain via the vestibulocochlear nerve and provide a sense of balance and spatial orientation. But disorders affecting the vestibular system (e.g., Ménière's disease or inflammation of vestibular anatomy) can cause vestibular deficiency by interfering with these sensory impulses, thereby negatively affect one's sense of balance and spatial orientation. Vertigo can also result. Treatments for disorders of the vestibular system can include treatment with electrical stimulation via an electrode placed in the recipient's vestibule via the stapes footplate with a final position near the otolithic organs or vestibular nerve. However, placing an electrode in the proper position near or touching target anatomy (e.g., proximate the otolithic organs in the vestibule) is a surgical and technical challenge. The otolith organs, which include the saccule and utricle, are fragile and are suspended in the space of the vestibule via fine soft tissue membranes. Such treatment targets can be difficult to reach with high accuracy to ensure that electrical stimulation reaches the target structures without substantially stimulating non-target structures (e.g. ampullae of the semicircular canals). Traditional approaches for implantation include pushing an electrode array into the vestibule by a set distance or stopping when the electrode array meets a certain amount of resistance. Such blind insertion technique can be challenging to perform.

Disclosed examples include techniques and devices to facilitate implantation of a vestibular electrode array proximate a target treatment location of the recipient's vestibular system. An example vestibular electrode array can include a variety of mechanisms to provide fine control of the vestibular electrode array's position in the vestibular space. Further, the position can be guided by real time feedback mechanisms, such as fluoroscopy or electrophysiological measures to assist with positioning the vestibular electrode array.

In an example, an implanter (e.g., a clinician directly or via the use of a robotic positioner or micropositioner) controls the depth and trajectory of the vestibular stimulation array using a straight or curved stylet. The implanter can use the stylet to guide the electrodes of the vestibular electrode array to a target location (e.g., proximate the recipient's inferior vestibular nerve). The stylet can be coupled to the vestibular stimulation array, such as by being permanently embedded in the vestibular electrode array. Alternatively, the stylet is configured to be removed from a lumen in the vestibular electrode array. The coupling between the stylet and the vestibular stimulation array can be such that movement of the proximal end of the stylet controls the depth of implantation as well as an angle of the tip of the vestibular electrode array. The stylet can provide firmer control compared to a relatively malleable vestibular electrode array, such as by being relatively stiffer than the vestibular electrode array. The stylet can be configured to guide the vestibular electrode array through the oval window or a cochleostomy, such as by being sized and shaped to fit though such an opening while being coupled to the vestibular electrode array. The stylet can be a curved stylet by having a slight curve at a distal end of the stylet, which can provide fine control of the position of the tip of the vestibular electrode array by rotating the stylet. The stylet can take any of a variety of forms and can be made from any of a variety of different materials, such as one or more metals, alloys, polymers, glass, other materials, or combinations thereof. The stylet can be constructed to be stiff or malleable (e.g., relative to the vestibular electrode array). The stylet can have a shape-memory characteristic instigated by heat or electric current. The stylet and or the vestibular electrode array can include smart polymers having a shape controllable by the application of electric current. Certain implementations can be such that the stylet is configured to be mounted to the recipient's skull. For example, after the vestibular stimulation array is guided to the target treatment location with the stylet, the stylet can be mounted to the recipient's skull to resist the vestibular stimulation array being dislodged from the target treatment location.

In some examples, an endoscopic optical fiber bundle integrated with the vestibular electrode array can be used by a clinician to visualize the interior of the vestibule. The optical fibers of the optical fiber bundle can be permanently embedded in the vestibular electrode array or can be configured to reside temporarily in a lumen of the vestibular electrode array and be removable after the electrode is fixed in position. Where the optical fiber is removable from a lumen, the lumen can be configured to be closed to avoid leaving an open pathway into the vestibule after implantation. For example, in certain implementations, a clear window can be located at the tip of the vestibular electrode array so that the distal end of the lumen is not open to the vestibule (e.g., the window seals the distal end of the lumen). In addition or instead, an open lumen may be closed by partially or completely filling the lumen with a substance or closing off the proximal end of the lumen with a plug or adhesive sealant. An alternative to a lumen disposed in the vestibular electrode array for receiving the optical fiber bundle can be a groove along a side of the vestibular electrode array configured to receive the optical fiber bundle. The groove can be sealed with tissue at the entry point after implantation. The optical fiber can be held in place via an interference fit with the groove or through loops (e.g., spans over the groove) that are sufficient to keep the optical fiber bundle in place during implantation.

In some examples, the insertion of the vestibular electrode array is conducted under fluoroscopic feedback. A radiopaque component in the vestibular electrode array (e.g., metal wires, a metal stylet, or a radiopaque marker) can be visualized in the resulting fluoroscopic image. A clinician can view the fluoroscopic feedback and modify a position of the vestibular electrode array based thereon. In addition or instead, the feedback can be used with an automatic or semi-automatic robotic positioner to adjust the position of the vestibular electrode array during implantation into the vestibule. The robotic positioner can control the electrode insertion depth, angle, or other position using, for example, manipulation of a stylet (e.g., as described above) based on the fluoroscopic feedback.

In some examples, the insertion of the vestibular electrode array is conducted under real time electrophysiological feedback. For example, the electrophysiological feedback can be a response by the recipient to a stimulus. For example, the stimulus can be provided and measured by the vestibular electrode array or by one or more other devices. In some examples, the response can be a neural response or a myogenic response to the provided stimulus. The electrophysiological feedback can be used to not only monitor implantation of the vestibular electrode array with respect to vestibular anatomy. For example, in some examples, the hearing function of the recipient is monitored during insertion of the vestibular electrode array using, for example, electrocochleography. Such monitoring can be used to facilitate determining implantation's effect on the recipient's residual hearing.

During insertion, feedback regarding the positioning of the vestibular electrode array can be provided to the clinician via any of a variety of techniques, such as visual feedback or audible feedback. For example, a device can detect the position of the vestibular electrode array (e.g., the positioning of a distal tip thereof) and emit a sound with a pitch or other feature indicating the proximity of the vestibular electrode array to desirable or undesirable locations. For example, rising pitch can indicate a closer position or better response from a target nerve.

The feedback that would be provided to the clinician (or other feedback) can be provided to an automatic or semi-automatic robot in a suitable format to allow the robot to adjust the position of the electrode in the vestibule. The robot can control the electrode insertion depth, angle, or other position using a technique like the stylet invention described above.

As should be appreciated, while particular examples are illustrated and discussed herein, the disclosed vestibular stimulation prostheses and processes described herein can be integrated in any of a variety of ways in accordance with many embodiments of the invention. The discussion is not meant to suggest that the disclosed vestibular stimulation examples are only suitable for implementation within systems akin to that illustrated in and described herein. In general, additional configurations can be used to practice the methods and systems herein and/or some aspects described can be excluded without departing from the processes and systems disclosed herein.

<FIG> illustrates a view of an example vestibular stimulation system <NUM> implanted relative to inner ear and vestibular anatomy of a recipient in accordance with certain embodiments herein. The vestibular stimulation system <NUM> is configured to provide therapeutic stimulation to a vestibular system of a recipient. In the illustrated configuration, the vestibular stimulation system <NUM> includes a vestibular stimulator <NUM> coupled to a vestibular electrode array <NUM> having an elongate carrier <NUM> with one or more vestibular electrodes <NUM> disposed thereon. As further illustrated, a stylet <NUM> has a distal end coupled to the elongate carrier <NUM> and a proximal end having an engagement <NUM> coupled to tissue of the recipient via a fastener <NUM>.

The vestibular electrode array <NUM> can refer to the combined structure that includes the elongate carrier <NUM> and the vestibular electrodes <NUM> that are disposed on the elongate carrier <NUM>. In an example implementation, the vestibular electrode array <NUM> is approximately <NUM> in diameter and approximately <NUM>-<NUM> in length with a number of vestibular electrodes <NUM> in the form of full-band or half-band or plate electrodes. The elongate carrier <NUM> is configured to dispose the one or more vestibular electrodes <NUM> proximate target vestibular anatomy, such as proximate the recipient's vestibular nerve, saccule, or utricle. The elongate carrier <NUM> can include other components, such as one or more components for connecting the elongate carrier <NUM> to tissue of the recipient. The elongate carrier <NUM> can further include one or more sensors (e.g., for sensing the vestibular system).

The elongate carrier <NUM> is a carrier for one or more components of the vestibular stimulation system <NUM>. The elongate carrier <NUM> can have a first end opposite a second end. The first end can be coupled to the vestibular stimulator <NUM>. The second end can have disposed thereon the one or more vestibular electrodes <NUM> and can be configured to be implanted proximate target vestibular tissue of a recipient. Thus, the elongate carrier <NUM> can serve as a connection between the vestibular stimulator <NUM> and the target anatomy. The elongate carrier <NUM> can further include electrical connections to connect two or more components of the vestibular stimulation system <NUM>. For example, the elongate carrier <NUM> can include one or more wires that connect one or more components (e.g., the vestibular electrodes <NUM>) with the vestibular stimulator <NUM>. In such a configuration, the elongate carrier <NUM> can convey electrical stimulation signals from the vestibular stimulator <NUM> to the vestibular electrodes <NUM>. The elongate carrier <NUM> can take any of a variety of forms. In an example, the elongate carrier <NUM> is made of a flexible material, such as formed with an elastomer, such as silicone. In some examples, the elongate carrier <NUM> can be or include an optical fiber bundle having vestibular electrodes <NUM> coupled thereto (see, e.g., optical fiber bundle <NUM> of <FIG>, infra). The optical fibers of the elongate carrier <NUM> can be used with a visualizer for facilitating implantation of the vestibular electrode array <NUM> (see, e.g., visualizer <NUM> of <FIG>, infra).

The one or more vestibular electrodes <NUM> are electrically conductive components via which stimulation can be provided. In some examples, the vestibular stimulation system <NUM> is configured to use the one or more vestibular electrodes <NUM> as sensors. The one or more vestibular electrodes <NUM> can have any of a variety of different shapes, sizes, profiles, and configurations. Example configurations of the vestibular electrodes can include configurations to encourage or resist penetrating tissue of the recipient. In some examples, the one or more vestibular electrodes <NUM> and the elongate carrier (e.g., a lead and body) can be as described in <CIT>.

The stylet <NUM> can be an elongate component used to facilitate control the vestibular electrode array <NUM> during implantation. In many examples, the stylet <NUM> is stiffer than the elongate carrier <NUM> and imparts rigidity to the elongate carrier <NUM> during implantation of the vestibular electrode array <NUM>. With the added rigidity, the implanter (e.g., the clinician or the robot performing the implantation) can manipulate the elongate carrier <NUM> directly or indirectly via the stylet <NUM>.

The stylet <NUM> can be used to finely control a position of the vestibular electrode array <NUM> proximate a target vestibular treatment location <NUM>. The stylet <NUM> can be manipulated by a clinician's hands directly or via a mechanical tool (e.g., the robotic positioner <NUM> or the micropositioner <NUM> of <FIG>, infra). By manipulating a proximal end of the stylet <NUM>, the implanter can control the depth and angle of the distal portion of the stylet <NUM>, which in turn, controls the vestibular electrode array <NUM>.

The stylet <NUM> can be constructed from any of a variety of materials. The stylet <NUM> can be formed from a non-bioresorbable material, a bioresorbable material, or combinations thereof. At least a portion of the stylet <NUM> can be formed of a bioresorbable material that dissolves on exposure to a fluid, such as a saline solution or a body fluid of the recipient. The bioresorbable material can be selected from the group consisting of polyacrylic acid (PAA), polyvinyl alcohol (PVA), polylactic acid (PLA) and polyglycolic acid (PGA). The non-bioresorbable material can be, for example, a biocompatible metal, alloy, polymer, or glass material. In some examples, the stylet <NUM> can include, be, or be a part of an optical fiber bundle. Various stylets <NUM> and materials for use in embodiments disclosed herein, including those described in <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

In some examples, one or both of the stylet <NUM> and the vestibular electrode array <NUM> can be formed at least partially from a shape memory material. For example, a bimetallic element (e.g., nickel/titanium) can be shaped to take a substantially straight configuration at a first temperature (e.g., room temperature) and bend into another shape once it is exposed to a second temperature (e.g., body temperature during or after implantation). In examples, the shape memory material can be an electroactive polymer having shape memory characteristics that are modifiable via the application of an electric current. For example, the material can be held in a first position during insertion by an application of electric current to the material and then the material can be allowed to relax to a second position with the ceasing of the application of the electric current.

The stylet <NUM> can be configured to be stiff or malleable. In some examples, the stylet <NUM> can have different regions with different stiffnesses. For example, in some implementations, a portion of the stylet <NUM> being disposed within or proximate the elongate carrier <NUM> can be relatively more malleable than a remainder of the stylet <NUM>.

In some examples, the stylet <NUM> can be partially or wholly removed after implantation of the vestibular electrode array <NUM>. In some examples, the stylet <NUM> can partially or wholly remain implanted in the recipient after implantation is complete. For example, in the illustrated example, the stylet <NUM> can hold the vestibular electrodes <NUM> proximate a target vestibular treatment location <NUM> after implantation. The stylet <NUM> can have a distal end coupled to the elongate carrier <NUM> and a proximal end having an engagement <NUM> coupled to tissue of the recipient via a fastener <NUM>. The engagement <NUM> can be the portion of the stylet configured to facilitate coupling with tissue of the recipient, and the fastener <NUM> can be the component that couples with the tissue of the recipient. For example, the engagement <NUM> can be an eyelet formed at the proximal end of the stylet <NUM> and the fastener <NUM> can be a bone screw configured to be driven through the eyelet and into the recipient's skull with a head of the bone screw interacting with the eyelet to resist movement of the stylet <NUM>.

The vestibular stimulator <NUM> can be a component of the vestibular stimulation system <NUM> that generates the stimulation signals that are to be applied to the vestibular system. The vestibular stimulator <NUM> can include a housing <NUM> in which one or more components of the vestibular stimulator <NUM> are disposed. The vestibular stimulator <NUM> can include any of a variety of components, such as a battery <NUM>, an electronics module <NUM>, and a stimulator <NUM> disposed within a housing <NUM>.

The housing <NUM> can be an encasement constructed from or coated in a biocompatible material to facilitate long-term implantation of the vestibular stimulator <NUM> in a recipient. The housing <NUM> can surround and hermetically seal one or more components of the vestibular stimulator. In examples, the housing <NUM> includes a header providing an interconnection between one or more components within and external to the housing <NUM>.

The electronics module <NUM> can include one or more components that provide vestibular stimulation or other functionality. In some examples, the electronics module <NUM> includes one or more components for receiving a signal (e.g., from external or implanted devices and sensors) and one or more components for converting the signal into a stimulation signal, such as a transceiver and an antenna. In some examples, the electronics module <NUM> generates a stimulation signal without regard to a signal from an external device. In some examples, the stimulation signal is generated according to a predetermined stimulation schedule that defines when and at what intensity the stimulation is to be applied, and the electronics module can include one or more components defining the stimulation schedule.

In some examples, the electronics module <NUM> includes one or more processors (e.g., central processing units or microcontrollers) coupled to memory components (e.g., flash memory or ROM) storing instructions that, when executed, cause performance of an operation described herein. In some examples, the electronics module <NUM> generates and monitors parameters associated with generating and delivering the stimulus (e.g., output voltage, output current, or line impedance). In some examples, the electronics module <NUM> can generate a telemetry signal that includes telemetry data based on one or more of the parameters. The electronics module <NUM> can send the telemetry signal to an external device or store the telemetry signal in memory for later use or retrieval.

As illustrated, the electronics module <NUM> can include a stimulator <NUM>. The stimulator <NUM> generates electrical stimulation signals for use in stimulating tissue. The stimulator <NUM> can use stimulation control signals generated by the electronics module <NUM> (e.g., based on a stimulation schedule, based on one or more sensors, or based on commands received from an external device) to generate electrical stimulation signals (e.g., electrical current signals) for delivery to the recipient's vestibular anatomy via the one or more vestibular electrodes <NUM>. In this way, the vestibular stimulation system <NUM> electrically stimulates the recipient's vestibular anatomy (e.g., nerve cells thereof), in a manner that causes the recipient to perceive vestibular percepts. In some examples, in addition to or instead of causing the recipient to perceive vestibular percepts, the stimulation can have a calming, masking, or impeding effect on an over-active vestibular system of the recipient. The stimulation can be monopolar stimulation or multipolar stimulation (e.g., bipolar).

The battery <NUM> can be a component configured to store power. The battery <NUM> can include, for example, one or more rechargeable or non-rechargeable batteries. In some examples, the vestibular stimulator <NUM> can be configured to receive power from another device, such as an external device or another implanted device. The power stored by the battery <NUM> can be distributed to the other components of the vestibular stimulator <NUM> as needed for operation.

The vestibular stimulator <NUM> can be a standalone vestibular stimulation prosthesis. In other examples, the vestibular stimulation system <NUM> can be part of another implanted medical device to add vestibular stimulation capabilities to the device. For instance, the implanted medical device can be a sensory prosthesis relating to one or more of the recipient's senses. For example, the sensory prosthesis can be a prosthesis relating to one or more of the five traditional senses (vision, hearing, touch, taste, and smell) and/or one or more of the additional senses. The sensory prosthesis can be an auditory prosthesis medical device configured to treat a hearing-impairment of the recipient. Where the sensory prosthesis is an auditory prosthesis, the sensory prosthesis can take a variety of forms including a cochlear implant, an electroacoustic device, a percutaneous bone conduction device, a passive transcutaneous bone conduction device, an active transcutaneous bone conduction device, a middle ear device, a totally-implantable auditory device, a mostly-implantable auditory device, an auditory brainstem implant device, a hearing aid, a tooth-anchored hearing device, a personal sound amplification product, other auditory prostheses, and combinations of the foregoing (e.g., binaural systems that include a prosthesis for a first ear of a recipient and a prosthesis of a same or different type for the second ear). In examples, the sensory prosthesis can be or include features relating to bionic eyes. Technology disclosed herein can also be relevant to applications with devices and systems used in for example, sleep apnea management, tinnitus management, and seizure therapy. Technology disclosed herein can be used with sensory devices such as consumer auditory devices (e.g., a hearing aid or a personal sound amplification product).

In some examples, the vestibular stimulator <NUM> (and the vestibular stimulation system <NUM> as a whole) can include one or more aspects of the devices, methods, and computer programs for generating one or more signals for the electrical stimulation of the saccule and utricle of a patient as described in <CIT>.

The vestibular stimulator <NUM> can be implemented in any of a variety of ways. In some implementations, the vestibular stimulator <NUM> can lack electronics and instead include an inductively or capacitively coupled wire. In some examples, power can be harvested from the body through heat or movement.

<FIG> further shows the vestibular stimulation system <NUM> disposed in relation to vestibular and auditory anatomy. Among the anatomy shown, is the ear canal, which is part of the auditory anatomy. Disposed across an end of ear canal is a tympanic membrane which vibrates in response to sound waves and is vibrationally coupled to the oval window (also known as the fenestra ovalis), which is adjacent round window, through the ossicular chain. The ossicular chain includes the malleus, the incus, and the stapes. In typical anatomy, the stapes includes the stapes footplate (also known as the base). The ossicular chain causes the oval window to vibrate in response to the vibration of the tympanic membrane, which causes motion within the cochlea that causes nerve impulses to be generated and transferred through the auditory nerve to the brain where they are perceived as sound.

In addition to the auditory anatomy, vestibular anatomy is also shown: the vestibular canals (also known as the semicircular canals) and the otolith organs. The vestibular canals are three canals (known as the horizontal canal, the superior canal, and the posterior canal) that allow rotational movement to be sensed. The otolith organs, which include the utricle and saccule, allow linear movement to be sensed. Rotational and linear movement cause appropriate nerve impulses to be generated via the vestibular anatomy and transferred through the vestibular nerve to the brain where they are perceived as motion.

The human skull is formed from a number of different bones that support various anatomical features. These bones are omitted from the figure to aid the viewer. The temporal bone is situated at the side and base of the recipient's skull. The temporal bone is covered by a portion of the recipient's skin, muscle, and fat, which can collectively be referred to as tissue. The temporal bone can be referred to as having a superior portion and a mastoid portion. The superior portion comprises the section of the temporal bone that extends superior to the auricle. That is, the superior portion is the section of the temporal bone that forms the side surface of the skull. The mastoid portion is positioned inferior to the superior portion and is the section of the temporal bone that surrounds the middle ear.

The various components of the vestibular stimulation system <NUM> can be disposed with reference to this anatomy. In particular, the illustrated configuration shows the elongate carrier <NUM> (and thus the one or more vestibular electrodes <NUM> coupled thereto) having a distal tip disposed at a target vestibular treatment location <NUM> proximate the saccule of a recipient's left or right auditory anatomy. In the illustrated example, the target vestibular treatment location <NUM> is such that the vestibular electrodes <NUM> are in contact with the vestibule without piercing the vestibule. In other examples, the target vestibular treatment location <NUM> is within the vestibule and the elongate carrier <NUM> at least partially pierces the vestibule and contacts underlying tissue. In an example, the vestibular electrodes <NUM> are disposed within the vestibule proximate one or both of the saccule and the utricle. In addition, while the vestibular stimulator <NUM> and the proximal end of the stylet <NUM> are illustrated as being located superior to the cochlea, the vestibular stimulator <NUM> and the stylet <NUM> can be located in any of a variety of locations.

One or more components of the vestibular stimulation system <NUM> can be provided to a clinician can be provided as part of a kit. The kit can further include components to facilitate implantation. An example of the kit is described in relation to <FIG>.

<FIG> illustrates an example kit <NUM> that includes the vestibular stimulator <NUM> as well as other components that can be used with the vestibular stimulator <NUM> during implantation. The kit <NUM> can be a packaging of one or more components for use with the vestibular stimulator <NUM>. The kit <NUM> can include components for use during implantation. The illustrated kit <NUM> includes the vestibular stimulator <NUM>, the vestibular electrode array <NUM>, a first stylet <NUM> having a straight portion <NUM>, a second stylet <NUM> having a curved portion <NUM>, a fastener <NUM>, a robotic positioner <NUM>, a micropositioner <NUM>, a sealant <NUM>, a plug <NUM>, an optical fiber bundle <NUM> of one or more optical fibers <NUM> coupled to a visualizer <NUM>. More or fewer components can be included as part of the kit <NUM>. In addition, one or more of the components can be provided as part of another kit.

The first stylet <NUM> can be a stylet <NUM> having a straight portion <NUM> proximate the distal tip of the stylet <NUM>. The second stylet <NUM> can be a stylet <NUM> having a curved portion <NUM> proximate the distal tip of the stylet <NUM>. The curve in the stylet <NUM> can be used to permit a user to more finely control position of the tip of the electrode by rotating the stylet <NUM>. As illustrated, the stylets <NUM> are separate from the vestibular electrode array <NUM>. In some examples, one or more of the stylets <NUM> are removably or irremovably pre-installed into the vestibular electrode array <NUM>. For example, a distal portion of the stylet <NUM> is embedded in the vestibular electrode array <NUM>. A distal portion of a stylet <NUM> can be coupled to the vestibular electrode array <NUM> via a dissolvable adhesive that is dissolved during implantation so the stylet <NUM> can be removed when it is no longer used. In some examples, the kit <NUM> includes a plurality of different stylets <NUM> of various characteristics (e.g., stiffnesses) from which a clinician can choose.

The fastener <NUM> can be a component configured to secure the stylet <NUM>. For example, in the illustrated embodiment, the fastener <NUM> is a bone screw configured to secure a proximal portion of the stylet <NUM> to the recipient's skull to secure the stylet <NUM>. The fastener <NUM> can take other forms. The fastener <NUM> can be an adhesive, a tack, or a component to encourage tissue growth. As further illustrated, the fastener <NUM> is a component separate from the stylet <NUM> and is configured to interface with an engagement <NUM> of the stylet. In other examples, the fastener <NUM> is at least partially integrated with the stylet <NUM>.

The robotic positioner <NUM> can be a component configured to automatically perform at least one aspect of guiding the vestibular electrode array <NUM> to the target vestibular treatment location <NUM>. In some examples, the robotic positioner <NUM> can be configured to automatically perform all of the guidance of the vestibular electrode array <NUM> to the target location or the robotic positioner <NUM> can automatically assist a clinician in performing certain implantation functions. The robotic positioner <NUM> can include one or more sensors, processors, and actuators configured to obtain data regarding the position of the vestibular electrode array <NUM>, process the data, and activate the one or more actuators based thereon. The vestibular electrode array <NUM>, stylet <NUM>, or another component can be coupled to the robotic positioner <NUM> (e.g., to one or more of the actuators thereof) such that actuation of one or more of the actuators causes movement of the vestibular electrode array <NUM>.

The micropositioner <NUM> can be a manually-manipulatable device that permits a clinician to finely control the position of the vestibular electrode array <NUM>. For example, the micropositioner <NUM> can permit a user to more finely control a position of the vestibular electrode array <NUM> than the user would be able to without the micropositioner <NUM>. The vestibular electrode array <NUM>, the stylet <NUM>, or another component can be coupled to the micropositioner <NUM> such that manipulation of the micropositioner <NUM> causes movement of the vestibular electrode array <NUM>. In some examples, the micropositioner <NUM> can be or include a universal joint that can be used to manipulate the stylet <NUM> and lock the stylet <NUM> in place as needed.

The sealant <NUM> and plug <NUM> can be components configured to seal or plug an opening in a component of the kit <NUM>. For example, as described in more detail below in <FIG>, the vestibular electrode array <NUM> can include a lumen for carrying the optical fiber bundle <NUM>. The sealant <NUM> or plug <NUM> can be configured to seal an opening of the lumen of the elongate carrier. In many examples, the sealant <NUM> is a paste contained in a tube that, when applied and allowed to cure or dry, forms a durable barrier. The plug <NUM> can be a pre-formed object that can be applied to an opening to form a barrier.

The optical fiber bundle <NUM> of one or more optical fibers <NUM> can be components to facilitate the transmission of light. For example, the optical fiber bundle <NUM> can be used to transmit light to a region proximate the distal end of the vestibular electrode array <NUM> during implantation and carry reflected light back to permit a clinician to visualize implantation and facilitate navigation of the vestibular electrode array <NUM> to a desired treatment location. The proximal end of the optical fiber bundle <NUM> can be coupled to visualizer <NUM>. In some examples, the optical fiber bundle <NUM> is configured to be operated separate from the vestibular electrode array <NUM> (e.g., the optical fiber bundle <NUM> need not be coupled to the vestibular electrode array <NUM>). In other examples, the elongate carrier <NUM> can be configured to receive or couple with the optical fiber bundle <NUM> such that movement of the elongate carrier <NUM> causes movement of the optical fiber bundle <NUM>.

The visualizer <NUM> can be a component configured to couple with a proximal end of the optical fiber bundle <NUM> to facilitate use of the optical fiber bundle <NUM> during implantation of the vestibular electrode array <NUM>. The visualizer <NUM> can be or include a light source, an eyepiece, a camera lens, and/or an image sensor. Where the visualizer <NUM> includes the light source, the visualizer <NUM> receives light output by the light source and directs the light through one or more of the optical fibers <NUM>. The light can then exit the distal end of the optical fibers <NUM> to provide illumination during implantation. Where the visualizer <NUM> includes an eyepiece or camera lens, such components can receive light reflected through one or more of the optical fibers <NUM> from an object illuminated by the light emitting from the distal end of the optic fibers <NUM>. A magnifying or focusing device can be further incorporated with the visualizer <NUM>. The camera lens can be part of a video system that permits recording of the image detected by an image sensor. The video can be used in real time during implantation, such as by being displayed on a screen.

The optical fiber bundle <NUM> or other components can be configured to couple with the vestibular electrode array <NUM>. The coupling can be achieved in any of a variety of ways. An example implementation is shown in <FIG>.

<FIG> make up <FIG>, which illustrates a first example implementation of a vestibular electrode array <NUM> with an optical fiber bundle <NUM> coupled thereto. <FIG> illustrates a side view of the vestibular electrode array <NUM>. <FIG> illustrates a cross-section view of the vestibular electrode array <NUM> taken along line B-B of <FIG> illustrates a cross-section view of the vestibular electrode array <NUM> taken along line C-C of <FIG>.

As illustrated, the vestibular electrode array <NUM> includes an elongate carrier <NUM> that is configured to be implanted proximate a vestibular organ of a recipient. The illustrated vestibular electrode array <NUM> includes at least one vestibular electrode <NUM> coupled to the elongate carrier <NUM>. As further illustrated, an optical fiber bundle <NUM> of one or more optical fibers <NUM> is coupled to the elongate carrier <NUM> such that implantation of the elongate carrier <NUM> can be monitored via the optical fiber bundle <NUM>. In addition, the illustrated elongate carrier <NUM> defines a groove <NUM> at least partially along a side of the elongate carrier <NUM>.

The groove <NUM> can be configured to receive the optical fiber bundle <NUM>. In an example, the groove <NUM> can be sized and shaped to permit the optical fiber bundle <NUM> to be disposed in the groove <NUM> for a distance without the optical fiber bundle <NUM> extending past a maximum diameter of the vestibular electrode array <NUM>. In another example, at least a portion of the optical fiber bundle <NUM> can extend past the maximum diameter of the elongate carrier <NUM>.

The elongate carrier <NUM> can be configured to retain the optical fiber bundle <NUM> in the groove <NUM>. In some examples, the elongate carrier <NUM> can be so configured by defining the groove <NUM> such that an interference fit exists between the groove <NUM> and the optical fiber bundle <NUM>. In the illustrated example, the elongate carrier <NUM> comprises one or more spans <NUM> over the groove <NUM>. The one or more spans <NUM> can be configured to retain the optical fiber bundle <NUM> in the groove <NUM>). A span <NUM> can be a portion of material extending over the groove <NUM> and defining an opening underneath the span <NUM> through which the optical fiber bundle <NUM> can pass. In the illustrated example, the spans <NUM> extend completely over the groove <NUM> in certain sections along the elongate carrier <NUM>. In other examples, the spans <NUM> can be cantilevered over the groove <NUM> such that the spans <NUM> partially overhang the groove <NUM> to retain the optical fiber bundle <NUM> in the groove <NUM> but that can be bent to permit the optical fiber bundle <NUM> to be inserted into or removed from the groove <NUM>. The fit between the optical fiber bundle <NUM> and the opening formed by the groove <NUM> and the spans <NUM> can retain the optical fiber bundle <NUM> in place during implantation such that the optical fiber bundle <NUM> can be used to visualize implantation.

As shown in <FIG>, the illustrated vestibular electrode array <NUM> includes one or more wires <NUM>. The distal ends of the wires <NUM> can be coupled to a vestibular electrode <NUM> and the proximal ends of the wires <NUM> can couple to the vestibular stimulator <NUM>, such that stimulation signals can be transmitted along the wires <NUM> to cause stimulation via the vestibular electrodes <NUM>. Other signals can be transmitted, such as sensing signals.

The illustrated vestibular electrode array <NUM> further includes a catch <NUM>. The catch <NUM> can be a feature of the elongate carrier <NUM> with which the stylet <NUM> can interact. For example, the catch <NUM> can be configured to receive a stylet <NUM> to guide the elongate carrier <NUM> during insertion of the elongate carrier <NUM>. The catch <NUM> can be so configured by, for example, being sized and shaped to receive the stylet within the catch <NUM>. In some examples the stylet <NUM> is configured to be irremovably coupled with the catch <NUM> (e.g., the stylet <NUM> cannot be removed without causing damage to the stylet <NUM> or the elongate carrier <NUM>). For example, the stylet <NUM> can be glued into the catch <NUM> or embedded within the material forming the catch <NUM> during manufacture of the elongate carrier <NUM>. In other examples, the stylet <NUM> can be configured to be removable from the catch <NUM> (e.g., the stylet <NUM> can be removed without causing substantial damage to the stylet <NUM> or the elongate carrier <NUM>). For example, there can be a threaded connection between the stylet <NUM> and the catch <NUM> such that the stylet <NUM> can be removed by unscrewing the stylet <NUM> from the catch <NUM>. In other examples, the stylet <NUM> can be glued into the catch <NUM> with a dissolvable adhesive. The stylet <NUM> can be removed via the application of a solution to dissolve the adhesive.

One or more of the components of the vestibular electrode array <NUM> can be radiopaque to facilitate visualization of the vestibular electrode array <NUM>. In the illustrated example, the vestibular electrode array <NUM> further includes a marker <NUM>. The marker <NUM> can be radiopaque.

As mentioned above, the implementation shown in <FIG> is an example. Another example implementation is shown in <FIG>.

<FIG> make up <FIG>, which illustrates a second example implementation of a vestibular electrode array <NUM> with an optical fiber bundle <NUM> disposed in a lumen <NUM> of the elongate carrier <NUM>. <FIG> illustrates a side view of the vestibular electrode array <NUM>. <FIG> illustrates a cross-section view of the vestibular electrode array <NUM> taken along line B-B of <FIG> illustrates a cross-section view of the vestibular electrode array <NUM> taken along line C-C of <FIG>.

The lumen <NUM> can extend at least partially along the length of the elongate carrier <NUM> and be sized and shaped to accommodate the optical fiber bundle <NUM> being disposed therein. The optical fiber bundle <NUM> can be removably or irremovably disposed therein. A distal portion of the lumen <NUM> can terminate at a window <NUM>. The window <NUM> can be an optically transparent region. The optical fiber bundle <NUM> can have a distal end disposed proximate the window <NUM> such that at least some of the light transmitted via the optical fiber bundle <NUM> can pass through the window to permit visualization of an area proximate the window. In some examples, the window <NUM> hermetically seals the distal end of the lumen <NUM>. In some examples, the window <NUM> is a discrete component from the elongate carrier <NUM>. In other examples, the window <NUM> can be a portion of the elongate carrier <NUM> that is optically transparent. In some examples, the window <NUM> is more optically transparent than the elongate carrier <NUM>. In some examples, the window <NUM> can be configured as a lens.

As further illustrated, the vestibular electrode array <NUM> can include a stopper <NUM>. The stopper <NUM> can be a component coupled to the elongate carrier <NUM> at a location and being configured to resist the elongate carrier <NUM> being advanced more than a predetermined distance. For example, the stopper <NUM> can be formed as a buildup of material. In the illustrated example, the stopper <NUM> is an annular collar disposed around a location of the elongate carrier <NUM>. In an example, the stopper <NUM> can be sized such that the stopper <NUM> cannot extend through a particular portion of a recipient's anatomy, such as the recipient's oval window, the recipient's round window, a cochleostomy opening, or an opening in the recipient's stapes. The stopper <NUM> can be coupled with the elongate carrier <NUM> (e.g., through a friction fit) such that if movement of the stopper <NUM> is blocked, then movement of the elongate carrier <NUM> is resisted. Thus, the stopper <NUM> can resist or prevent the elongate carrier <NUM> from extending further than a predetermined distance. In some examples, the stopper <NUM> is a separate component from the elongate carrier and can be disposed in a configurable position along the elongate carrier <NUM>.

The components of the vestibular electrode array of <FIG> and the other figures described above can be used in any of a variety of ways. An example method that can use one or more of the components described above is shown in <FIG>.

<FIG> and <FIG> make up <FIG>, which illustrates an example method <NUM> for implanting a vestibular electrode array and stimulating with the array. The method <NUM> can include operation <NUM>.

Operation <NUM> includes making components available for use. For example, the operation <NUM> can include making a vestibular electrode array <NUM> available for use. In some examples, the operation <NUM> can include making a vestibular electrode array <NUM> available for use that has a stylet <NUM> pre-installed. In some examples, the operation <NUM> can include making a vestibular electrode array <NUM> available for use that has an optical fiber bundle <NUM> pre-installed. Making the vestibular electrode array <NUM> available for use can include making a vestibular electrode array <NUM> available for use that has an elongate carrier <NUM> constructed from an optical fiber bundle <NUM> and having vestibular electrodes <NUM> coupled to the optical fiber bundle <NUM>. The operation <NUM> can include making a stylet <NUM> having a straight portion <NUM> proximate a distal end of the stylet <NUM> available for use. For example, the operation <NUM> can include making a stylet <NUM> having a curved portion <NUM> proximate a distal end of the stylet <NUM> available for use. In some examples, the operation <NUM> can include installing or coupling one or more components with respect to each other. For example, the operation <NUM> can include coupling the stylet <NUM> with the vestibular electrode array <NUM> (e.g., by coupling the stylet <NUM> with the catch <NUM>). In an example, the stylet <NUM> is removably inserted into the catch <NUM> of the vestibular electrode array <NUM>. The operation <NUM> can include coupling the optical fiber bundle <NUM> with the vestibular electrode array <NUM>, such as by placing the optical fiber bundle <NUM> at least partially within the groove <NUM> (e.g., and securing the optical fiber bundle <NUM> with the spans <NUM>) or the lumen <NUM> depending on the configuration of the vestibular electrode array <NUM>. Following operation <NUM>, the flow of the method <NUM> can move to operation <NUM>.

Operation <NUM> can include preparing recipient tissue. For example, the operation <NUM> can include sterilizing tissue of the recipient and surgically accessing an implantation area in the recipient. For example, the clinician can form one or more incisions in tissue proximate a location where the vestibular stimulation system <NUM> is to be implanted and remove tissue to expose an implantation area. The opening formed by one or more incisions can be sized and shaped to allow for the performance of operations described herein to be performed through the opening. In some examples, surgically accessing the implantation area includes performing a mastoidectomy or a cochleostomy. The operation can further include forming or enlarging a posterior tympanotomy, which can include exposing the oval window, such as by superiorly enlarging the posterior tympanotomy. In some examples, surgically accessing the implantation area includes identifying the target vestibular treatment location <NUM>. In some examples, a pocket or a bone bed can be formed for the vestibular stimulator <NUM> to be disposed in. Operation <NUM> can include operation <NUM> and <NUM>. Operation <NUM> includes forming an opening in a stapes of the recipient. For example, the opening can be formed in a footplate of the stapes, such as by using a surgical drill. Operation <NUM> includes forming an opening proximate the oval window of a recipient. In an example, the operation <NUM> includes removing the stapes of the recipient and forming the opening in the oval window. In another example, an opening is formed through the anulus of the oval window beside the stapes footplate. Following operation <NUM>, the flow of the method <NUM> can move to operation <NUM>.

Operation <NUM> includes guiding the vestibular electrode array <NUM> to a target vestibular treatment location <NUM> in the recipient. The guiding can be performed in whole in or part by a human clinician. In some examples, the guiding can be performed in whole or in part via a robotic positioner <NUM> or a micropositioner <NUM>, such as by moving the vestibular electrode array with the robotic positioner <NUM> or the micropositioner <NUM>. As shown in more detail in <FIG>, operation <NUM> can include a variety of operations.

Operation <NUM> can include guiding a component through an opening in the stapes footplate. As described above, the method <NUM> can include forming an opening in the stapes footplate of the recipient. A portion of the vestibular electrode array <NUM> can be guided through the opening in the stapes. In some examples, additional components are also guided through the opening, such as the stylet <NUM> and the optical fiber bundle <NUM>.

Operation <NUM> can include guiding a component through an opening in the oval window. As described above, the method can include forming an opening in the recipient's oval window. A portion of the vestibular electrode array <NUM> can be guided through the opening in the oval window. In some examples, additional components are also guided through the opening, such as the stylet <NUM> and the optical fiber bundle <NUM>.

Operation <NUM> can include guiding a component through a cochleostomy opening. As described above, the method can include performing a cochleostomy. A portion of the vestibular electrode array <NUM> can be guided through the opening formed by the cochleostomy. In some examples, additional components are also guided through the opening, such as the stylet <NUM> and the optical fiber bundle <NUM>.

Operation <NUM> can include guiding via a stylet <NUM>. For example, guiding the vestibular electrode array <NUM> to the target vestibular treatment location <NUM> in the recipient can include moving a proximal end of the stylet <NUM> (e.g., advancing, retracting, or tilting the proximal end) to control a depth of the vestibular electrode array <NUM> and an angle of a tip of the vestibular electrode array <NUM>. In some examples, the operation <NUM> can include twisting the stylet <NUM> substantially along the stylet's long axis. Twisting the curved stylet <NUM> can cause rotation of the distal tip of the stylet <NUM>, which can induce movement in a plane substantially perpendicular to the long axis. That movement can provide fine control of the position of the tip of the vestibular electrode array <NUM>. An example of twisting a curved stylet <NUM> is shown in <FIG>.

<FIG> illustrates an example view of a vestibular electrode array <NUM> being advanced to a target vestibular treatment location <NUM> using a stylet <NUM> having a curved portion at a distal end of the stylet. As illustrated, rotation of the stylet <NUM> causes the distal portion of the vestibular electrode array <NUM> to rotate into position at the target vestibular treatment location <NUM>. An alternate insertion location through a cochleostomy opening is further illustrated as an arrow.

Returning to <FIG>, operation <NUM> can include using a stapes footplate as a fulcrum. For example, the footplate of the stapes can be used as a fulcrum to permit fine control of a distal portion of the stylet <NUM> while a user manipulates a proximal portion of the stylet <NUM>. A relatively proximal portion of the stylet <NUM> can be placed against the footplate of the stapes and the point of contact can act as a pivot point by which to manipulate a more distal portion of the stylet <NUM>.

Operation <NUM> can include monitoring a position via an optical fiber bundle <NUM> of one or more optical fibers <NUM>. The position of the distal portion of the vestibular electrode array <NUM> can be monitored. In some examples, the position of the vestibular electrodes <NUM> can be monitored. The monitoring can be the result of direct visualization of the component (e.g., as may be accomplished by an optical fiber bundle <NUM> separate from the vestibular electrode array <NUM>) or via indirect visualization. For example, the distal tip of the optical fiber bundle <NUM> can be proximate the distal end of the vestibular electrode array <NUM> such that little or no portion of the vestibular electrode array <NUM> is visible. Nonetheless, the position of the vestibular electrode array <NUM> or a component thereof can be inferred by what is visualized through the optical fiber bundle <NUM>. For example, the implanter can assume that what is being visualized through the distal portion of the optical fiber bundle <NUM> sufficiently closely corresponds to the position of the distal portion of the vestibular electrode array <NUM> that the visualization can be useful in guiding the vestibular electrode array <NUM>. The monitoring with the optical fiber bundle <NUM> can include using the optical fiber bundle <NUM> to carry light generated proximate the proximal end of the optical fiber bundle <NUM> out the distal end of the optical fiber bundle <NUM>. The light can illuminate the area proximate the distal end of the optical fiber bundle <NUM> and can be reflected back and carried through the optical fiber bundle <NUM> to reach a visualizer <NUM> coupled to the proximal end of the optical fiber bundle <NUM>. The implanter can visualize the reflected light directly via the visualizer <NUM> or via another component connected to the visualizer <NUM>. An example illustration showing the monitoring of a position via the optical fiber bundle <NUM> is shown in <FIG>.

<FIG> illustrates an example view of a vestibular electrode array <NUM> being advanced to a target vestibular treatment location <NUM> using a stylet <NUM> while under visualization of an optical fiber bundle <NUM>. As illustrated, the optical fiber bundle <NUM> is coupled to the vestibular electrode array <NUM> as the vestibular electrode array is advanced to the target vestibular treatment location <NUM> with the stylet <NUM>. The vestibular electrode array <NUM> is shown as being advanced through an opening in the recipient's stapes. But an alternate insertion location through a cochleostomy opening is further illustrated as an arrow.

Returning to <FIG>, operation <NUM> can include providing an indication of position. For example, the position can be the position of a portion of the vestibular electrode array <NUM>, a component thereof, or another component (e.g., a portion of the stylus <NUM> or the optical fiber bundle <NUM>). A device can detect the position of the component using any of a variety of techniques (e.g., surgical navigation position determining techniques). The indication of position can be provided via any of a variety of techniques, such as visual feedback or audible feedback. In some examples, the operation <NUM> can include operation <NUM> or operation <NUM>. Operation <NUM> can include providing an audible indication of position. For example, the operation can include providing the audible indication of the position via a speaker. The relative position can be indicated via a change in pitch of an audible indication. Operation <NUM> can include providing a visual indication of position. In some examples, the visual indication is provided on a display of a computer system that tracks the position. A surgeon can use a surgical microscope for visualizing anatomy. The view from the surgical microscope can be provided at the display of a computer system and one or more items of feedback can be provided on the display (e.g., concurrent with the view from the surgical microscope as a heads up display). In some examples, one or more lights be used to indicate position (e.g., by flashing or changing color).

Operation <NUM> can include obtaining a fluoroscopic image showing a location of a component of the vestibular electrode array <NUM>. For example, the vestibular electrode array <NUM> can include a radiopaque marker <NUM>. The obtained fluoroscopic image can show a location of the radiopaque marker <NUM> or another radiopaque component of the vestibular electrode array <NUM> relative to the target vestibular treatment location <NUM>. The implanter can use the obtained image to determine a position of the vestibular electrode array <NUM> relative to the target vestibular treatment location <NUM>, which can be used to guide the vestibular electrode array <NUM>.

Operation <NUM> can include obtaining electrophysiological feedback. The electrophysiological feedback can include direct or indirect feedback regarding a position of the vestibular electrode array <NUM>. The feedback can further include information regarding an effect of the implantation on the recipient, such as an effect of the implantation on the recipient's residual hearing. Operation <NUM> can include operation <NUM>, operation <NUM>, and operation <NUM>.

Operation <NUM> can include providing a stimulus. For example, providing the stimulus can include providing the stimulus with at least one vestibular electrode <NUM> of the vestibular electrode array or the effect of the implantation procedure on the recipient. Operation <NUM> can include measuring a response to the stimulus. For example, measuring the response can include measuring a neural or myogenic response to the provided stimulus. The response can be measured using one or more of a variety of different sensors. In some examples, the vestibular electrode array <NUM> includes a sensor. In some examples, one or more of the vestibular electrodes <NUM> can act as a sensor. The one or more sensors can generate data indicative of the recipient's response. For example, where the response is a neural response, the one or more sensors can detect electrical activity indicative of the response to the stimulation. Such a neural response can detect whether the vestibular electrodes <NUM> are able to stimulate the recipient's vestibular nerve or other tissue. Where the response is a myogenic response, one or more sensors within the recipient or external to the recipient can detect muscle movement of the recipient that can be in response to the applied stimulation.

Operation <NUM> can include monitoring hearing of the recipient. For example, the hearing or other aspects of the recipient can be monitored using electrocochleography. Electrocochleography can include measuring compound action potential of the auditory nerve in response to test signals applied, using, for example, an electrode disposed proximate the eardrum or the middle ear of a patient. In another example, an auditory brainstem response measurement device may be employed to measure the electrical potential near the region of the brain (e.g. the dorsal and ventral cochlear nuclei of the brainstem) that processes the cochlear input response to test signals applied to an implantable transducer. In this example, one or more electrodes positioned at various locations on the scalp of a patient may be employed to measure the auditory brainstem response potentials. Examples of techniques for performing electrocochleography are described in <CIT> and <CIT>.

Operation <NUM> can include modifying a position of the vestibular electrode array <NUM> based on obtained electrophysiological feedback. The feedback (e.g., measured myogenic or neural response) can be used as an indication of whether the vestibular electrode array <NUM> is disposed in the correct location such that the vestibular electrodes <NUM> can stimulate the desired tissue. For example, the vestibular electrode array <NUM> can be advanced to a location believed to be appropriate, stimulation can be provided, and, based on the response, the vestibular electrode array <NUM> can remain in the location or be moved to a different location to retest until the response has desired characteristics. The obtained electrophysiological feedback can indicate that the vestibular electrode array <NUM> is in an incorrect position, and the implanter can modify the position of the vestibular electrode array <NUM> to attempt to move the vestibular electrode array <NUM> to the correct location.

Operation <NUM> can include activating a shape memory characteristic. For example, the operation <NUM> can include permitting activation of the shape memory characteristic caused by a body temperature of the recipient. The operation <NUM> can include applying heat to activate the shape memory characteristic. In some examples, the operation <NUM> can include activating the shape memory characteristic with the application of electrical current. The activation of the shape memory characteristic can cause the component having the shape memory characteristic (e.g., the vestibular electrode array <NUM> or the stylet <NUM>) to change shape. In some examples, the change shape can facilitate implantation. For instance, the shape memory characteristic can cause the vestibular electrode array <NUM> to be relatively straight and stiff during the application of an electrical current, which can facilitate passage of the vestibular electrode array <NUM> through an opening. After the vestibular electrode array <NUM> passes through the opening, the electrical current can be stopped, which can cause the vestibular electrode array <NUM> to relax.

As described above, the operation <NUM> of guiding the vestibular electrode array to a target vestibular treatment location <NUM> can include any of a variety of operations. Following operation <NUM>, the flow of the process can move to operation <NUM>, which is shown in <FIG>.

Operation <NUM> can include mounting a proximal portion of the stylet <NUM> to tissue of the recipient. In an example, operation <NUM> can be performed before or after guiding the vestibular electrode array <NUM> to the target vestibular treatment location <NUM>. For example, the tissue of the recipient to which the proximal portion of the stylet <NUM> is mounted can be the recipient's skull. This mounting can fix a position of the proximal portion of the stylet <NUM>, which can resist movement of the distal portion of the stylet <NUM>. The mounting technique can vary depending on the configuration of the stylet <NUM>, engagement <NUM>, and the fastener <NUM>. For example, where the fastener <NUM> is a screw, the fastener <NUM> can be screwed into the recipient's skull such that the fastener <NUM> engages with the engagement <NUM> (e.g., an eyelet through which the screw extends). Where the fastener <NUM> is an adhesive, the operation <NUM> can include adhering the engagement <NUM> (e.g., which can be a structure, such as a paddle, configured to provide a surface area to which the adhesive can adhere). The stylet <NUM> can be left behind in the recipient after implantation and the recipient has healed.

Operation <NUM> can include removing the optical fiber bundle <NUM>. For example, the operation <NUM> can include removing the optical fiber bundle <NUM> from the elongate carrier <NUM>. The optical fiber bundle <NUM> can be removed from the groove <NUM>. In other examples, the optical fiber bundle <NUM> can be removed from the lumen <NUM>. The optical fiber bundle <NUM> can be removed via the application of force, such as by pulling on the optical fiber bundle <NUM> in a manner sufficient to overcome a friction or other fit. In some examples, a shape memory characteristic or dissolvable material can be used to remove the optical fiber bundle <NUM>. For example, applying or ceasing application of an electrical current to a shape memory component can cause the optical fiber bundle <NUM> to be released.

Operation <NUM> can include cutting the optical fiber bundle <NUM>. In some examples, after implanting the vestibular electrode array <NUM>, the optical fiber bundle <NUM> is no longer of use. Rather than removing the optical fiber bundle <NUM> (e.g., from the lumen <NUM>), the optical fiber bundle <NUM> can be left in the recipient (e.g., the recipient can be sutured to close the one or more incisions with the optical fiber bundle <NUM> remaining in the recipient), but a portion of the optical fiber bundle <NUM> extending outside of the elongate carrier <NUM> can cut and removed. The portion of the optical fiber bundle <NUM> remaining in the elongate carrier <NUM> can be allowed to remain in the recipient. In some examples, the portion remaining can be treated with an adhesive or sealant after the cutting. The portion of the optical fiber bundle <NUM> remaining in the vestibular electrode array <NUM> can be left behind in the recipient after implantation and the recipient has healed.

Operation <NUM> can include sealing an opening of the elongate bundle with a plug <NUM> or sealant <NUM>. For example, during some implantation procedures, an opening can be created or left in the elongate carrier (e.g., by the removal of the optical fiber bundle <NUM> or by cutting the optical fiber bundle <NUM>). The opening can be sealed via application of a plug <NUM> or sealant <NUM> to close the opening.

Operation <NUM> can include delivering stimulation with the vestibular electrodes. For example, the vestibular stimulator <NUM> can cause the vestibular electrodes <NUM> to deliver stimulation to tissue proximate the vestibular electrodes <NUM>. The stimulation can be delivered to the target vestibular treatment location <NUM>. In some examples, the stimulation is provided continuously or periodically. In some examples, the stimulation is provided based on output from one or more sensors (e.g., accelerometers or gyroscopes that measure the recipient's balance).

The above techniques are described primarily in the context of a standalone vestibular stimulator <NUM>. But, in other examples, the vestibular stimulation system <NUM> can be part of another implanted medical device to add vestibular stimulation capabilities to the device. For instance, the implanted medical device can be a sensory prosthesis relating to one or more of the recipient's senses, such as the cochlear implant system described below in <FIG>.

<FIG> illustrates an example cochlear implant system <NUM> that can benefit from use of the technologies disclosed herein. The cochlear implant system <NUM> includes an implantable component <NUM> typically having an internal receiver/transceiver unit <NUM>, a stimulator unit <NUM>, and an elongate lead <NUM>. The internal receiver/transceiver unit <NUM> permits the cochlear implant system <NUM> to receive signals from and/or transmit signals to an external device <NUM>. The external device <NUM> can be a button sound processor worn on the head that includes a receiver/transceiver coil <NUM> and sound processing components. Alternatively, the external device <NUM> can be just a transmitter/transceiver coil in communication with a behind-the-ear device that includes the sound processing components and microphone.

The implantable component <NUM> includes an internal coil <NUM>, and preferably, a magnet (not shown) fixed relative to the internal coil <NUM>. The magnet can be embedded in a pliable silicone or other biocompatible encapsulant, along with the internal coil <NUM>. Signals sent generally correspond to external sound <NUM>. The internal receiver/transceiver unit <NUM> and the stimulator unit <NUM> are hermetically sealed within a biocompatible housing, sometimes collectively referred to as a stimulator/receiver unit. Included magnets (not shown) can facilitate the operational alignment of an external coil <NUM> and the internal coil <NUM>, enabling the internal coil <NUM> to receive power and stimulation data from the external coil <NUM>. The external coil <NUM> is contained within an external portion. The elongate lead <NUM> has a proximal end connected to the stimulator unit <NUM>, and a distal end <NUM> implanted in a cochlea <NUM> of the recipient. The elongate lead <NUM> extends from stimulator unit <NUM> to the cochlea <NUM> through a mastoid bone <NUM> of the recipient. The elongate lead <NUM> is used to provide electrical stimulation to the cochlea <NUM> based on the stimulation data. The stimulation data can be created based on the external sound <NUM> using the sound processing components and based on the sensory prosthesis settings. As illustrated, the stimulator unit <NUM> further includes the stimulator <NUM> configured to deliver stimulation to vestibular tissue of the recipient via electrodes of the vestibular electrode array <NUM> disposed proximate the oval window of the recipient. The vestibular electrode array <NUM> connects the stimulator <NUM> to the vestibular electrodes <NUM> of the vestibular electrode array <NUM>.

In certain examples, the external coil <NUM> transmits electrical signals (e.g., power and stimulation data) to the internal coil <NUM> via a radio frequency (RF) link. The internal coil <NUM> is typically a wire antenna coil having multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire. The electrical insulation of the internal coil <NUM> can be provided by a flexible silicone molding. Various types of energy transfer, such as infrared (IR), electromagnetic, capacitive and inductive transfer, can be used to transfer the power and/or data from external device to cochlear implant. While the above description has described internal and external coils being formed from insulated wire, in many cases, the internal and/or external coils can be implemented via electrically conductive traces.

Other sensory prostheses can benefit from technologies described herein. For example, the technology disclosed herein can be implemented with a direct acoustic stimulator prosthesis configured to generate vibrations and conduct the vibrations to move perilymph in scala tympani to activate hair cells to cause hearing percepts. Such a stimulator can include an actuator, a stapes prosthesis and a coupling element connecting the actuator to the stapes prosthesis. In an example, the prosthesis stimulation arrangement can be implanted and/or configured such that a portion of stapes prosthesis abuts a recipient's round or oval window. In examples, the portion of the prosthesis that abuts the oval window can include one or more vestibular electrodes <NUM> described herein for stimulating vestibular anatomy.

As should be appreciated, while particular uses of the technology have been illustrated and discussed above, the disclosed technology can be used with a variety of devices in accordance with many examples of the technology. The above discussion is not meant to suggest that the disclosed technology is only suitable for implementation within systems akin to that illustrated in the figures. For examples, while certain technologies described herein were primarily described in the context of auditory prostheses (e.g., cochlear implants), technologies disclosed herein are applicable to medical devices generally (e.g., medical devices providing pain management functionality or therapeutic electrical stimulation, such as deep brain stimulation). 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. Further, the techniques described herein can be applicable to determining a recipient's response to other stimuli, such as visual stimuli, tactile stimuli, olfactory stimuli, taste stimuli, or other stimuli. Likewise, the devices used herein need not be limited to auditory prostheses and can be other medical devices configured to support a human sense, such as bionic eyes.

This disclosure described some aspects of the present technology with reference to the accompanying drawings, in which only some of the possible aspects were shown. Other aspects can, however, be embodied in many different forms and should not be construed as limited to the aspects set forth herein. Rather, these aspects were provided so that this disclosure was thorough and complete and fully conveyed the scope of the possible aspects to those skilled in the art.

As should be appreciated, the various aspects (e.g., portions, components, etc.) described with respect to the figures herein are not intended to limit the systems and processes to the particular aspects described. Accordingly, additional configurations can be used to practice the methods and systems herein and/or some aspects described can be excluded without departing from the methods and systems disclosed herein.

Similarly, where steps of a process are disclosed, those steps are described for purposes of illustrating the present methods and systems and are not intended to limit the disclosure to a particular sequence of steps. For example, the steps can be performed in differing order, two or more steps can be performed concurrently, additional steps can be performed, and disclosed steps can be excluded without departing from the present disclosure. Further, the disclosed processes can be repeated.

Claim 1:
An apparatus comprising:
an elongate carrier (<NUM>) configured to be implanted proximate a vestibular organ of a recipient;
at least one vestibular electrode (<NUM>) coupled to the elongate carrier (<NUM>); and
an optical fiber bundle (<NUM>) of one or more optical fibers (<NUM>),
characterized in that
the optical fiber bundle (<NUM>) is coupled to the elongate carrier (<NUM>) such that implantation of the elongate carrier (<NUM>) can be monitored via the optical fiber bundle (<NUM>); and
the optical fiber bundle (<NUM>) is removable from the elongate carrier (<NUM>).