Hearing preserving vestibular stimulation

Abstract

Presented herein are techniques and devices configured for preserving the residual hearing ability of the recipient while providing vestibular stimulation.

Description

HEARING PRESERVING VESTIBUEAR STIMULATIONBACKGROUNDField of the Invention[oooi] The present invention relates to techniques for hearing preservation with a vestibular stimulation device.Related Art

[0002] Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices can include internal or implantable components / devices, external or wearable components / devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). Medical devices, such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and / or lifestyle enhancement functions and / or recipient monitoring for a number of years.

[0003] The types of medical devices and the ranges of functions performed thereby have increased over the years. For example, many medical devices, sometimes referred to as “implantable medical devices,” now often include one or more instruments, apparatuses, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease / injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and / or data received from external devices that are part of, or operate in conjunction with, implantable components.SUMMARY

[0004] In one aspect, a method is provided. The method comprises: surgically accessing an implantation area in a recipient; implanting a stimulating assembly of a vestibular stimulation device proximate to an ossicular chain of the recipient, wherein the stimulating assembly comprises one or more electrodes; and attaching the stimulating assembly to a portion of theossicular chain of the recipient such that the one or more electrodes contact the portion of the ossicular chain.

[0005] In another aspect, an apparatus is provided. The apparatus comprises: a stimulating assembly including one or more electrodes configured to be implanted in a recipient; a coupling element configured to attach the stimulating assembly to an ossicular chain of the recipient so the one or more electrodes are in contact with the ossicular chain; an implantable housing remote from the stimulating assembly, the implantable housing having a stimulator disposed therein that is configured to deliver electrical stimulation signals to vestibular tissue of a recipient via the one or more electrodes; and a lead electrically connecting the stimulator to the one or more electrodes of the stimulating assembly.

[0006] In another aspect, a method is provided. The method comprises: generating one or more electrical stimulation signals; delivering, via one or more electrodes configured to be implanted in a recipient, the one or more electrical stimulation signals to a first area of a vascularized bone of a recipient; and conducting, via blood vessels in the vascularized bone, the one or more electrical stimulation signals from the first area of a vascularized bone to a target stimulation area of the recipient.

[0007] In another aspect, a method is provided. The method comprises: implanting one or more electrodes proximate to a vascularized bone in a recipient; and delivering electrical stimulation signals to the recipient via the one or more electrodes and the vascularized bone.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Embodiments of the present invention are described herein in conjunction with the accompanying drawings, in which:

[0009] FIG. 1A is an example view of a vestibular stimulation device implanted relative to middle and inner ear anatomy, in accordance with certain embodiments presented herein;

[0010] FIG. IB illustrates an exemplary technique for coupling the stimulating assembly with the electrodes to the stapes crus, in accordance with certain embodiments presented herein;[ooii] FIG. 1C is a block diagram of a stimulator unit of the vestibular stimulation device, in accordance with certain embodiments presented herein;

[0012] FIG. 2A is an example view of a vestibular stimulation device implanted relative to middle and inner ear anatomy, in accordance with certain embodiments presented herein;

[0013] FIG. 2B illustrates an exemplary technique for coupling the stimulating assembly with the electrodes to the stapes footplate, in accordance with certain embodiments presented herein;

[0014] FIG. 3 is a flowchart of example method, in accordance with certain embodiments presented herein;

[0015] FIG. 4 is a flowchart of an example method, in accordance with certain embodiments presented herein; and

[0016] FIG. 5 is a flowchart of an example method, in accordance with certain embodiments presented herein.DETAILED DESCRIPTIONOverview

[0017] Presented herein are techniques in which one or more electrodes are configured to be implanted proximate to preferentially vascularized tissue (e.g., hard tissue such as bone and adjoining soft tissue) in a recipient. The one or more electrodes deliver electrical stimulation signals (current signals) to the preferentially vascularized tissue, where the preferentially vascularized tissue includes blood vessels that are configured (e.g., oriented) to guide / channel the electrical stimulation signals to a target stimulation area (e.g., target nerve cells). For example, the electrical stimulation signals are delivered to a first area of preferentially vascularized tissue and blood vessels in the preferentially vascularized tissue are configured to guide / channel the electrical stimulation signals from the first area of vascularized towards the target stimulation area of the recipient.

[0018] One example application of the techniques presented herein relates to implantable medical devices such as cochlear implants or vestibular stimulation devices, each of which include one or more electrodes configured to be implanted in a recipient. In certain cases, implantation of the electrodes can impede or damage residual function, such as residual hearing abilities, of the inner ear. As such, providing a hearing preserving way to stimulate target stimulation areas, such as the otolith organs (e.g., saccule), is not straightforward because the otolith organs are located behind the stapes footplate. In addition, most vestibular stimulators either stimulate the semicircular canals (SCCs) or the otolith organ in a destructive manner.To address these issues, a solution involving vestibular stimulation on and through the preferentially vascularized tissue of the ossicular chain (e.g., the stapes bone) and the adjoining soft tissue (e.g., mucosa) is provided. For example, the stapes bone is vascularized hard tissue that includes blood vessels, and is adjoined (e.g., surrounded by) by vascularized soft tissue that also include blood vessels. Electrical stimulation signals are delivered to, for example, the hard tissue of the ossicular chain, and the blood vessels of the hard tissue and / or the adjoining soft tissue are preferentially vascularized (e.g., oriented) to guide / channel the stimulation signals (current) to a distal end of the stapes, where the stimulation signals then pass through inner ear fluid to vestibular tissue. The use of the vascularized hard tissue and adjoining soft tissue to guide / channel the stimulation signals toward a target stimulation area is sometimes referred to herein as “electrical bone conduction.” As such, devices and methods described herein provide components and techniques for electrical bone conduction, including stimulating the stapes bone of the ossicular chain (e.g., the lower part of the stapes) directly with one or more electrode(s), with the that the stapes bone and / or adjoining tissue conducts the electrical stimulation towards the otolith organ (e.g., the saccule) to treat, for example, balance / mobility / motor disorders, tinnitus, etc.

[0019] In view of the above, certain aspects of the techniques presented herein include one or more electrodes configured to be implanted in the middle ear of a recipient, proximate to the ossicular chain, while preserving the residual hearing ability of the recipient. In particular, a vestibular stimulation device in accordance with certain embodiments presented herein includes a stimulating assembly that is configured to be implanted proximate to the ossicles (e.g., the stapes bone), where the stimulating assembly includes one or more electrodes. During implantation, the stimulating assembly can be fixed / secured to the recipient to retain the stimulating assembly at a selected position (e.g., proximate to the stapes bone, adjacent to the oval window) and such that one or more electrodes that are configured (e.g., positioned) to deliver electrical stimulation to the ossicles.

[0020] That is, the stimulating assembly includes one or more electrodes that, when positioned proximate to the stapes bone adjacent to the oval window, are configured to deliver stimulation signals (current signals) to the recipient’s vestibular system to achieve a therapeutic effect. For example, the stimulation signals can be delivered to the recipient to treat a variety of conditions / disorders, such as balance disorders or other disorders affecting the vestibular system (e.g., Meniere’s disease, other bilateral vestibular disorders, or inflammation of vestibular anatomy), vertigo, motor disorders (e.g., Parkinson’s disease, ataxia, essentialtremor, etc.), tinnitus, etc. As described further below, the one or more electrodes can also be used to detect nerve response to stimulation.

[0021] According to one example embodiment, stimulating assembly could include a body with one or more electrodes (contacts) fixed to the stapes, or wound around the stapes, or connected to the back of the stapes footplate. In some other example embodiments, a plurality of electrodes can be used to provide a more robust solution (e.g., in case one of the electrodes is less effective than another). The implantable body housing the one or more electrodes, and / or the electrodes themselves, and / or a coupling element, can be very lightweight and flexible to reduce / minimize any mechanical loading that is created on the stapes, for example.

[0022] There are a number of different types of devices in / with which embodiments of the present invention can be implemented. Merely for ease of description, the techniques presented herein are primarily described with reference to a specific device in the form of vestibular stimulation devices. However, it is to be appreciated that the techniques presented herein can also be partially or fully implemented by any of a number of different types of devices, including consumer electronic device (e.g., mobile phones), wearable devices (e.g., smartwatches), hearing devices, implantable medical devices, wearable devices, etc., consumer electronic devices, wearable devices (e.g., smart watches, etc.), etc. As used herein, the term “hearing device” is to be broadly construed as any device that acts on an acoustical perception of an individual, including to improve perception of sound signals, to reduce perception of sound signals, etc. In particular, a hearing device can deliver sound signals to a user in any form, including in the form of acoustical stimulation, mechanical stimulation, electrical stimulation, etc., and / or can operate to suppress all or some sound signals. As such, a hearing device can be a device for use by a hearing-impaired person (e.g., hearing aids, middle ear auditory prostheses, bone conduction devices, direct acoustic stimulators, electro-acoustic hearing prostheses, auditory brainstem stimulators, bimodal hearing prostheses, bilateral hearing prostheses, dedicated tinnitus therapy devices, tinnitus therapy device systems, combinations or variations thereof, etc.), a device for use by a person with normal hearing (e.g., consumer devices that provide audio streaming, consumer headphones, earphones, and other listening devices), a hearing protection device, etc. In other examples, the techniques presented herein can be implemented by, or used in conjunction with, various implantable medical devices, such as visual devices (i.e., bionic eyes), sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, seizure devices (e.g., devicesfor monitoring and / or treating epileptic events), sleep apnea devices, electroporation devices, etc.Vestibular Stimulation Device

[0023] As noted, a vestibular stimulation device can restore vestibular function in recipients having vestibular deficiency. According to an aspect of the present invention, a stimulating assembly is appended onto the recipient’s ossicular chain such that the stimulating assembly interfaces with, for example, with the stapes of the ossicular chain, and can be configured to preserve inner ear anatomy and to avoid penetrating into the inner ear. Electrical stimulation is provided using one or more electrodes of the stimulating assembly to stimulate the vestibular system (e.g., the otolith organs thereof). In an example, a stimulator unit connected to the stimulating assembly via a lead is also implanted. The stimulator unit can have a small and convenient form factor. In some instances, the stimulator unit is a stand-alone device that is configured to provide stimulation the recipient’s vestibular system without respect to signals received from devices external to the recipient. In some other implementations, the stimulator unit is a component of a sensory prosthesis (e.g., a cochlear implant or bionic eye) or another medical device.

[0024] Positioning of the stimulating assembly proximate to the stapes can provide several advantages. For example, the stapes (and thereby the oval window) are sufficiently close to the otolith organs to provide relatively easy targeting of stimulation to the otolith organs. In addition, the stimulation signals from the electrodes to the stapes can more easily penetrate through the oval window than other bony structure within the middle ear cavity (e.g., the temporal bone), which can allow for the use of relatively lower intensity stimulation and relatively lower collateral damage to tissue.

[0025] The example embodiments described below further include particular stimulating assembly and electrode arrangements and designs for use with the vestibular stimulation device, particular coupling arrangements and designs for connecting the stimulating assembly with anatomy of the recipient, and processes for implanting the vestibular stimulation device and providing therapeutic stimulation during operation. The specific arrangements provided herein are illustrative and the techniques presented herein can be implemented with, for example, different stimulation arrangements, different stimulator unit arrangements, different coupling elements, etc.

[0026] FIG. 1A is a diagram illustrating an example vestibular stimulation device 100 with which aspects of the techniques presented herein can be implemented. The vestibular stimulation device 100 is an apparatus configured to provide therapeutic stimulation to a vestibular system of a recipient. The vestibular stimulation device 100 can be implanted relative to anatomical structures of the ear, and can be disposed in relation to vestibular and auditory anatomy in particular, as described in detail below. FIG. 1A also shows relevant components of outer ear 101, middle ear 102, and inner ear 103.

[0027] As shown in FIG. 1A, the auditory anatomy of the outer ear 101 includes an ear canal 104 and a tympanic membrane 106 disposed across the distal end of ear canal 104. Acoustic pressure or sound waves can be channeled into and through ear canal 104, and the tympanic membrane 106 vibrates in response to the acoustic pressure or sound waves. The vibration is coupled to oval window 110 (also known as the “fenestra ovalis”) of the cochlea 120 through three bones of the middle ear 102, which are collectively referred to as the ossicles 111 (or the ossicular chain). The ossicles 111 (bones) of the middle ear 102 include a malleus 112, an incus 113, and a stapes 114. As described further below, the stapes 114 includes a footplate (base) adjacent to the oval window 108 / 110, and a pair of legs (anterior crus and posterior crus) that extend from the footplate (towards the incus 113). The ossicles 111 (bones 112, 113, 114) are positioned in the middle ear cavity and serve to filter and amplify the acoustic pressure or sound waves. The ossicles 111 (bones 112, 113, 114) cause the oval window 110 to articulate (e.g., vibrate) in response to the vibration of the tympanic membrane 106. This vibration of the oval window 110 sets up waves of fluid motion of the perilymph within the cochlea 120. Such fluid motion, in turn, activates tiny hair cells (not shown) inside of the cochlea 120. Activation of the hair cells causes appropriate nerve impulses to be generated and transferred through the spiral ganglion cells (not shown) and the auditory nerve (not shown) to the brain (also not shown) where they are perceived as sound.

[0028] In addition to the auditory anatomy, vestibular anatomy is also shown in FIG. 1 A. The vestibular anatomy includes the vestibular canals 115 (also known as the semicircular canals) and the otolith organs 116, which include utricle 117 and saccule 118. The vestibular canals 115 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 116 (the utricle 117 and the saccule 118) allow linear movement to be sensed. Rotational and linear movement cause appropriate nerve impulses to be generated via the vestibular anatomy and transferred throughthe auditory nerve (not shown) to the brain (also not shown) where they are perceived as motion.

[0029] In the illustrated configuration of FIG. 1A, the vestibular stimulation device 100 includes a stimulator unit 150 , a stimulating assembly 160 having one or more electrodes 162 (also referred to as contacts), and a lead 140 (e.g., a cable or wire) connecting the stimulator unit 150 to the stimulating assembly 160. Components of the stimulator unit 150 are described in further detail below with reference to FIG. 1C. As described below, the one or more electrodes 162 can be used to stimulate portions of the recipient via the ossicles 111.

[0030] More specifically, the stimulator unit 150 is configured to generate and deliver stimulation signals to the recipient via the one or more electrodes 162 of the stimulating assembly 160. In certain examples, the stimulator unit 150 can also receive signals from the one or more electrodes 162 to, for example, perform vestibular response telemetry (e.g., for measuring electrically evoked compound action potential (ECAP) from a vestibular nerve of the recipient), perform electrocochleography, etc. The stimulating assembly 160 is implantable relative to anatomical structures of the middle ear and inner ear of the recipient, as shown in FIGs. 1A and IB (and / or alternatively, as shown in FIGs. 2A and 2B described below). Other configurations of the vestibular stimulation device 100 and components thereof (e.g., the stimulating assembly 160) are also possible.

[0031] The stimulator unit 150 can be a component of the vestibular stimulation device 100 that generates the stimulation signals that are to be applied to the vestibular system of the recipient. The stimulator unit 150 often includes a housing in which one or more components are disposed. An example configuration of the stimulator unit 150 is shown in FIG. 1C.

[0032] The lead 140 is a component that electrically connects two or more components of the vestibular stimulation device 100. In many examples, the lead 140 is a cable having one or more wires disposed within an insulated sheath. In the illustrated configuration, the lead 140 connects the stimulator unit 150 to the stimulating assembly 160. In such a configuration, the lead 140 can convey electrical stimulation signals from the stimulator unit 150 to the stimulating assembly 160 (e.g., to the electrodes 162 thereof).

[0033] The stimulating assembly 160 can be a carrier for one or more components of the vestibular stimulation device 100. In particular, the stimulating assembly 160 be a carrier for one or more components for providing stimulation to the vestibular system of the recipient, such as the one or more electrodes 162 (contacts). The one or more electrodes 162 areelectrically-conductive components via which stimulation is provided, and can have any of a variety of different shapes, sizes, profdes, and configurations in various example embodiments.

[0034] According to techniques described herein, the stimulating assembly 160 is configured to be placed proximate one of the ossicles 111 in the ossicular chain, including but not limited to the stapes 114 disposed proximate to the oval window 110. The stimulating assembly 160 can also include one or more components, such as a coupling element 168, to facilitate attaching, fixating, connecting, or otherwise coupling the stimulating assembly 160 (and the electrodes 162) to one of the ossicles 111 in the ossicular chain (e.g., the malleus 112, the incus 113, or the stapes 114). The coupling element 168 can facilitate the implantation of the stimulating assembly 160, positioning of the electrodes 162, and / or the targeting of the vestibular anatomy, for example. Such coupling elements are described in more detail below with reference to FIGs. IB and 2B. In some examples, the lead 140 itself could also be fixed / secured to a portion of the recipient, to further assist with retaining the stimulating assembly 160 (and the one or more electrodes 162) at the selected location / position with respect to the stapes 114. Optionally, the stimulating assembly 160 can further include one or more sensors (e.g., for sensing the vestibular system of the recipient).

[0035] The stimulating assembly 160 can take any of a variety of forms and can take any of a number of different shapes. In an example, a body of the stimulating assembly 160 (which comprises the one or more electrodes 162) can be formed as a mesh, which is relatively flexible. In an example, the body is formed with an elastomer, such as silicone. The stimulating assembly 160 can be sufficiently flexible to conform to a shape of a recipient’s stapes (e.g., the stapes footplate or the stapes crus) when implanted. The body of the stimulating assembly 160 can be configured to interface with a part of the stapes 114, for example. In one example (refer to FIGs. 2A and 2B), the body of the stimulating assembly 160 is configured to interface with a footplate 174 (base) of the stapes 114, which covers part of or the entirety of the oval window 110. In another example (referring to FIGs. 1A and IB), the body of the stimulating assembly 160 is configured to interface with one of the legs (e.g., the anterior crus 175(A) and / or the posterior crus 175(B)) of the stapes 114. In certain examples, the posterior crus 175(B) is most accessible through a posterior tympanotomy and could be the likely candidate for attaching the stimulating assembly 160 thereto. The stimulating assembly 160 can be flat or can have concavities, convexities, ridges, waves, or other structural features.

[0036] According to an aspect of the techniques described herein, the stimulating assembly 160 upon implantation can be selectively configured in such a manner that one or moreelectrodes 162 are positioned to target stimulation of vestibular anatomy of the recipient (e.g., the saccule 118 of the otolith organs 116, for example) by delivering therapeutic stimulation to one of the ossicles 111 (e.g., the stapes 114, for example). The stimulating assembly 160 can be sized and shaped to facilitate placement of the stimulating assembly 160 proximate to target anatomy, and to facilitate useful contact between the electrodes 162 and the target anatomy. The stimulating assembly 160 can be flexible and can have a shape that facilitates a connection between the stimulating assembly 160 and the stapes 114 of the ossicular chain. The shape and configuration of the stimulating assembly 160 can be selected to resist damaging auditory anatomy, vestibular anatomy, tissue, or combinations thereof.

[0037] In addition, the surgical implantation can be performed such that the stimulating assembly 160 does not penetrate any delicate tissue / structures of the ear in proximity to the oval window 110, while avoiding anatomical damage of the vestibular canals 115, the otolith organs 116 (utricle 117 and saccule 118), and the cochlea 120. In general, the placement location with respect to a portion of the stapes 114 with which the stimulating assembly 160 (and electrodes 162) interfaces can depend on a variety of factors, such as size, ease of fixation, thickness, surfaces, accessibility, mechanical loading, optimal delivery of stimulation to one or more anatomical structures, relative distance from certain anatomical structures (e.g., oval window 110, utricle 117, saccule 118, etc.), although example embodiments are not limited thereto and other configurations are contemplated within the scope of the present disclosure.

[0038] In some examples, the stimulating assembly 160 is cut to remove a portion thereof, so as to adjust the size / length of the stimulating assembly 160 itself and / or to change the number of electrodes 162 present. In some alternative examples, a surgeon could be provided with a selection of different sized stimulating assemblies, with different numbers or configurations / arrangements of electrodes, and / or different shapes or materials, from which to choose. In either of these examples, the configuration of the stimulating assembly 160 and the electrodes 162 can be customized to adapt to different anatomies, different recipients, different placement locations, different orientations, etc. based on experience, pre-operative imaging data, or other recipient-specific information.

[0039] Thus, the various components of the vestibular stimulation device 100 can be disposed with reference to the anatomy as described above. In particular, the illustrated configuration shows the stimulating assembly 160 (and thus the one or more electrodes 162) disposed at least partially attached / connected / coupled to the stapes 114 adjacent to the oval window 110 of a recipient's left or right auditory anatomy. In this position, the stimulating assembly 160 (andthus the electrodes 162) is further proximate to the otolith organs 116 (utricle 117 and saccule 118) to which stimulation is channeled, via blood vessels of stapes 114 and / or blood vessels of adjoining tissue, to and then through the oval window 110. While the stimulator unit 150 is illustrated as being located inferior to the cochlea 120, the stimulator unit 150 can be located in any of a variety of locations. The stimulator unit 150 is described in more detail in relation to FIG. 1C.

[0040] FIG. IB illustrates an exemplary technique for coupling the stimulating assembly 160 (with the electrodes 162) to a first portion of the stapes 114 (e.g., the stapes crus 175(A) or the stapes crus 175(B)), in accordance with certain embodiments presented herein.

[0041] As shown in FIG. IB, the stapes 114 comprises a base (referred to herein as footplate 174) that partially of fully covers the oval window 110, a pair of legs (also referred to herein as an anterior crus 175(A) and a posterior crus 175(B)), a head (also known as a “capitulum”), and a neck that connects the legs (crus) with the head. The crus 175(A) and the crus 175(B) (the legs) are each connected to the footplate 174 (the base) at one end and joined at the neck at the other end (near the head).

[0042] As noted, the stimulating assembly 160 can include one or more components, referred to herein as a coupling element 168, configured for attaching, fixating, connecting, or otherwise coupling the stimulating assembly 160 (and the electrodes 162) to one of the ossicles 111 in the ossicular chain (e.g., the malleus 112, the incus 113, or the stapes 114). The coupling element can take any of a variety of forms. In the example shown in FIG. IB, the coupling element 168 can comprise one or more clips, connectors, clamps, hooks, fasteners, etc. Alternatively, screws, adhesives (e.g., surgical adhesives), or cements (e.g., bone cements) can be used as a coupling element 168. In some examples, the coupling element 168 can facilitate positioning of the stimulating assembly 160 and the electrodes 162 thereof.

[0043] In this example embodiment, once the stimulating assembly 160 is inserted to a desired position proximate to the stapes 114 adjacent to the oval window 110, the coupling element 168 is used to fix / secure the stimulating assembly 160 (and hence the one or more electrodes 162) directly to one of the crus 175(A) or the crus 175(B) (i.e., one of the legs) of the stapes 114 of the recipient. Thus, the coupling element 168 is configured to retain the stimulating assembly 160 (and the electrodes 162) at a selected position with respect to the stapes 114 (e.g., on the stapes crus 175(A) or the stapes crus 175(B) in this example).

[0044] In some examples, a fixation member (not shown) that is configured to be attached to a portion of the recipient (such as to bone), and to hold or fasten a portion of the lead 140 to the anatomy of the recipient, can also be provided for the device. Such a fixation member can be attached or fixed to the recipient (e.g., bone) using adhesives, cement, glue, clips, fasteners, screws, or other surgical techniques, and can be employed to prevent the stimulating assembly 160 from moving or becoming detached / decoupled or unintentionally penetrating into surrounding structures / tissue, by securing a portion of the lead 140 in a desired location / position.

[0045] FIG. 1C illustrates an example implementation of the stimulator unit 150. As shown in FIG. 1C, the stimulator unit 150 comprises a housing 152 and includes an electronics module 154 and a battery 158 disposed within the housing 152.

[0046] The housing 152 can be an encasement that surrounds and hermetically seals one or more components of the stimulator unit 150. In examples, the housing 152 comprises a biocompatible material. In some examples, the housing 152 includes a header providing an interconnection between the lead 140 and one or more components within the stimulator unit 150 (e.g., the electronics module 154 thereof).

[0047] The electronics module 154 can include one or more other components to provide vestibular stimulation functionality. In some examples, the electronics module 154 includes one or more components for receiving a signal from an external device and converting the signal into a stimulation signal. But in many examples, the electronics module 154 generates a stimulation signal without regard to a signal from an external device. In many 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.

[0048] In some examples, the electronics module 154 includes one or more processors (e.g., central processing units) coupled to memory components (e.g., flash memory) storing instructions that when executed cause performance of an operation described herein. In examples, the electronics module 154 generates and monitors parameters associated with generating and delivering the stimulus (e.g., output voltage, output current, or line impedance). In examples, the electronics module 154 generates a telemetry signal that includes telemetry data based on one or more of the parameters. The electronics module 154 can send the telemetry signal to an external device or store the telemetry signal in memory for later use or retrieval.

[0049] As illustrated, the electronics module 154 can include a stimulator 156. The stimulator 156 generates electrical stimulation signals for use in stimulating tissue. The stimulator 156 can use stimulation control signals generated by the electronics module 154 (e.g., based on a stimulation schedule) to generate electrical stimulation signals (e.g., current signals) for delivery to the recipient's vestibular anatomy via one or more electrodes (e.g., electrodes 162). In this way, the vestibular stimulation device 100 electrically stimulates the recipient's vestibular anatomy (e.g., nerve cells thereof), in a manner that causes the recipient to perceive vestibular percepts. The stimulation can be bipolar stimulation or monopolar stimulation, for example.

[0050] The battery 158 is a component configured to store power. The battery 158 includes, for example, one or more rechargeable or non-rechargeable batteries. In some examples, the stimulator unit 150 is configured to receive power from another device, such as an external device or another implanted device. The power stored by the battery 158 can be distributed to the other components of the stimulator unit 150 (e.g., the electronics module 154, the stimulator 156) as needed for operation.

[0051] In one example, the lead 140 is connected to the stimulator unit 150 via a connector 148. The connector 148 can comprise, for example, a physical connector or an inductive connector. In the case of a physical connector, the connector 148 is used to physically connect / disconnect the wires in the lead 140 to / from the stimulator unit 150. In the case of an inductive connector, the connector 148 can comprise a two-part transformer with a contactless connector (e.g., one transformer part in the lead 140 and one transformer part in the stimulator unit 150 or another lead extending therefrom). The use of an inductive connector as the connector 148 would avoid the need for a galvanic connection between the lead 140 and the stimulator unit 150. The presence of the connector 148 can enable a change or swap of the stimulator unit 150 with a different stimulator unit (e.g., due to a malfunction, or to upgrade the stimulator unit), while leaving the lead 140 and the stimulating assembly 160 implanted in the recipient.

[0052] As described herein, the stimulator unit 150 is connected via the lead 140 to the stimulating assembly 160 for providing stimulation via the electrodes 162. The stimulating assembly 160 and the electrodes 162 can take any of a variety of different configurations for the electrical stimulation of the otolith organs 116 (e.g., the utricle 117 and / orthe saccule 118).

[0053] The vestibular stimulation device 100 can be a standalone vestibular stimulation device . In other examples, the vestibular stimulation device 100 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.

[0054] 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).

[0055] FIG. 2A is a diagram illustrating another example vestibular stimulation device 200 with which aspects of the techniques presented herein can be implemented. The vestibular stimulation device 200 is an apparatus configured to provide therapeutic stimulation to a vestibular system of a recipient. The vestibular stimulation device 200 can be implanted relative to anatomical structures of the ear, and can be disposed in relation to vestibular and auditory anatomy in particular, as described in detail herein. Like reference numbers refer to like elements in FIG. 2A as described above with reference to FIG. 1A, and corresponding descriptions are not repeated below. The following disclosure will focus mainly on any differences in the example embodiment of FIG. 2A in comparison to the example embodiment ofFIG. 1A.

[0056] In the illustrated configuration of FIG. 2A, the vestibular stimulation device 200 includes a stimulator unit 150, a stimulating assembly 260 having one or more electrodes 262(also referred to as contacts), and a lead 140 (e.g., a cable or wire). The stimulator unit 150 can be a component of the vestibular stimulation device 200 that generates the stimulation signals that are to be applied to the vestibular system of the recipient. The lead 140 electrically connects the stimulator unit 150 to the stimulating assembly 260, and can convey electrical stimulation signals from the stimulator unit 150 to the stimulating assembly 260 (e.g., to the one or more electrodes 262 thereof). An example configuration and components of the stimulator unit 150 are described in further detail above with reference to FIG. 1C. The stimulating assembly 260 is implantable relative to anatomical structures of the middle ear and inner ear of the recipient, as shown in FIGs. 2A and 2B. Other configurations of the vestibular stimulation device 200 and components thereof (e.g., the stimulating assembly 260) are also possible.

[0057] The stimulating assembly 260 can be a carrier for one or more components of the vestibular stimulation device 200. In particular, the stimulating assembly 260 be a carrier for one or more components for providing stimulation to the vestibular system of the recipient, such as the one or more electrodes 262 (contacts). The one or more electrodes 262 are electrically-conductive components via which stimulation is provided, and can have any of a variety of different shapes, sizes, profiles, and configurations in various example embodiments. The stimulating assembly 260 is configured to be placed proximate the stapes 114, which is disposed proximate to the oval window 110. The stimulating assembly 260 can also include one or more components (e.g., coupling element 268) for attaching, fixating, connecting, or otherwise coupling the stimulating assembly 260 (and the one or more electrodes 262) to one of the ossicles 111 in the ossicular chain (e.g., the malleus 112, the incus 113, or the stapes 114). Such coupling elements are described in more detail below with reference to FIG. 2B. Optionally, the stimulating assembly 260 can further include one or more sensors (e.g., for sensing the vestibular system of the recipient).

[0058] The stimulating assembly 260 can take any of a variety of forms. In an example, a body of the stimulating assembly 260 (which comprises the one or more electrodes 262) is formed as a mesh, which is relatively flexible. In an example, the body is formed with an elastomer, such as silicone. The body of the stimulating assembly 260 is configured to interface with a part of the stapes 114, for example. In this example (referring to FIGs. 2A and 2B), the body of the stimulating assembly 260 is configured to interface with the footplate 174 (base) of the stapes 114, which covers part of or the entirety of the oval window 110.

[0059] According to an aspect of the techniques described herein, the body of the stimulating assembly 260 upon implantation is configured in such a manner that one or more electrodes 262 are positioned to target stimulation of vestibular anatomy of the recipient (e.g., the saccule 118 of the otolith organs 116, for example) by delivering stimulation to one of the ossicles 111 (e.g., the stapes 114, for example). More specifically, the stapes 114 comprises vascularized hard tissue, which is adjoined (e.g., surrounded) by vascularized soft tissue. The inventors have recognized the potential for electrical bone conduction at the middle ear, namely that electrical stimulation signals delivered to the stapes 114 (or other hard tissue of ossicular chain) are guided / channeled by the blood vessels of the stapes 114 and / or the adjoining soft tissue to a distal end of the stapes, where the stimulation signals then pass through the oval window 110 and into the inner ear fluid for stimulation of the vestibular tissue . That is, the stapes 114 and / or the adjoining soft tissue are preferentially vascularized such that the electrical stimulation signals delivered to the stapes 114 are directed towards the target stimulation area, which in this case is the vestibular tissue.

[0060] Generally, implantation of the stimulating assembly 260 is performed such that the stimulating assembly 260 does not penetrate any delicate tissue / structures of the ear in proximity to the oval window 110, while avoiding anatomical damage of the vestibular canals 115, the otolith organs 116 (utricle 117 and saccule 118), and the cochlea 120. Again, the placement location with respect to a portion of the stapes 114 with which the stimulating assembly 260 (and electrode 262) interfaces can depend on a variety of factors, such as ease of fixation, size, thickness, surfaces, accessibility, mechanical loading, optimal delivery of stimulation to one or more anatomical structures, relative distance from certain anatomical structures (e.g., oval window 110, utricle 117, saccule 118, etc.), although example embodiments are not limited thereto and other configurations are contemplated within the scope of the present disclosure.

[0061] In some examples, the stimulating assembly 260 is cut to remove a portion thereof, so as to adjust the size / length of the stimulating assembly 260 itself and / or to change the number of electrodes 262 present. In some alternative examples, a surgeon could be provided with a selection of different sized stimulating assemblies, with different numbers or configurations / arrangements of electrodes, and / or different shapes or materials, from which to choose. In either of these examples, the configuration of the stimulating assembly 260 and the electrodes 262 can be customized to adapt to different anatomies, different recipients, differentplacement locations, different orientations, etc. based on experience, pre-operative imaging data, or other recipient-specific information.

[0062] Thus, the various components of the vestibular stimulation device 200 can be disposed with reference to the anatomy described above. In particular, the illustrated configuration shows the stimulating assembly 260 (and thus the one or more electrodes 262) disposed at least partially attached / connected / coupled to the stapes 114 adjacent to the oval window 110 of a recipient's left or right auditory anatomy. In this position, the stimulating assembly 260 (and thus the electrodes 262) is further proximate to the otolith organs 116 (utricle 117 and saccule 118) to which stimulation is channeled / guided to and then through the oval window 110. While the stimulator unit 150 is illustrated as being located inferior to the cochlea 120, the stimulator unit 150 can be located in any of a variety of locations. The stimulator unit 150 is described in more detail in relation to FIG. 1C above.

[0063] FIG. 2B illustrates an exemplary technique for coupling the stimulating assembly 260 (with the electrode 262) to a second portion of the stapes 114 (e.g., the stapes footplate 174), in accordance with certain embodiments presented herein. Like reference numbers refer to like elements in FIG. 2B as described above with reference to FIG. IB, and corresponding descriptions are not repeated below. The following disclosure will focus mainly on any differences in the example embodiment of FIG. 2B in comparison to the example embodiment of FIG. IB.

[0064] As shown in FIG. 2B, the stapes 114 comprises a base (referred to herein as footplate 174) that partially of fully covers the oval window 110, a pair of legs (also referred to herein as an anterior crus 175(A) and a posterior crus 175(B)), a head (also known as a “capitulum”), and a neck that connects the legs (crus) with the head. The crus 175(A) and the crus 175(B) (the legs) are each connected to the footplate 174 (the base) at one end and joined at the neck at the other end (near the head).

[0065] As stated, the stimulating assembly 260 can include one or more components, referred to herein as a coupling element 268, for attaching, fixating, connecting, or otherwise coupling the stimulating assembly 260 (and the electrode 262) to one of the ossicles 111 in the ossicular chain (e.g., the malleus 112, the incus 113, or the stapes 114). In the example shown in FIG. 2B, the coupling element 268 can comprise surgical adhesive, bone cement, or the like. Alternatively, one or more clips, connectors, clamps, hooks, fasteners, screws, etc. can be used as a coupling element 268.

[0066] In this example embodiment, once the stimulating assembly 260 is inserted to a desired position proximate to the stapes 114 adjacent to the oval window 110, the coupling element 268 is used to fix / secure the stimulating assembly 260 (and hence the one or more electrodes 262) directly to the footplate 174 (base) of the stapes 114 of the recipient. Thus, the coupling element 268 is configured to retain the stimulating assembly 260 (and the one or more electrodes 262) at a selected position with respect to the stapes 114 (i.e., on the stapes footplate 174 in this example).

[0067] In some examples, a fixation member (not shown) that is configured to be attached to a portion of the recipient (such as to bone), and to hold or fasten a portion of the lead 140 to the anatomy of the recipient, can also be provided for the device. Such a fixation member can be attached or fixed to the recipient (e.g., bone) using adhesives, cement, glue, clips, fasteners, screws, or other surgical techniques, and can be employed to prevent the stimulating assembly 260 from moving or becoming detached / decoupled or unintentionally penetrating into surrounding structures / tissue, by securing a portion of the lead 140 in a desired location / position.

[0068] As mentioned above, an example configuration and components of the stimulator unit 150 is described with reference to FIG. 1C above, which applies similarly with respect to the example embodiment of FIGs. 2 A and 2B.

[0069] It is to be appreciated that the techniques presented herein (e.g., creating an opening, inserting a stimulating assembly, etc.) could be partially or fully implemented with assistance of surgical navigation / robotic surgical devices / equipment. The use of surgical navigation software and / or robotics could provide a highly accurate opening and insertion of electrode(s).

[0070] FIG. 3 is a flowchart illustrating one example method 300 for insertion of the stimulating assembly 160 and / or the stimulating assembly 260, in accordance with certain embodiments presented herein.

[0071] Method 300 begins at operation 310, which includes surgically accessing an implantation area in a recipient. A surgeon or clinical can form an incision to create an opening in tissue proximate a location where the vestibular stimulation device is to be implanted, and possibly remove tissue to expose the implantation area. For example, the stapes 114 of the recipient is surgically exposed by forming a first / primary surgical opening in the head of the recipient. In certain embodiments, the first surgical opening is formed to permit a superior approach to the stapes 114 (e.g., to footplate 174, or to crus 175(A) or crus 175(B)) oppositethe oval window 108 / 110 to, for example, expose at least one of the footplate 174, the crus 175(A), and / or the crus 175(B). In some examples, surgically accessing the implantation area includes identifying the stapes, as well as the anterior crus and the posterior crus of the stapes and / or the footplate of the stapes which contacts the oval window. In some examples, operation 310 can include excavating ossicular chain tissue to define a location for implanting the stimulating assembly (e.g., using a surgical tool such as a drill or a laser) to make room for the stimulating assembly.

[0072] At operation 320, method 300 includes implanting a stimulating assembly of a vestibular stimulation device proximate to an ossicular chain of the recipient, wherein the stimulating assembly comprises one or more electrodes. The stimulating assembly (e.g., the stimulating assembly 160 or the stimulating assembly 260) is inserted into a space proximate to the stapes 114 adjacent to the oval window 110. The stimulating assembly is inserted such that it does not damage any delicate tissue or structures of the middle ear and / or the inner ear, as described above. In some examples, the stimulating assembly is positioned such that the electrodes face the area where the recipient’s otolith organs are believed to be disposed.

[0073] At operation 330, method 300 includes attaching the stimulating assembly to a portion of the ossicular chain of the recipient such that the one or more electrodes contact the portion of the ossicular chain. In some examples, implanting the stimulating assembly includes placing the stimulating assembly at a stapes bone of the ossicular chain, such that the one or more electrodes are in contact with the crus or the footplate of the stapes, and attaching the stimulating assembly to the ossicular chain includes attaching the stimulating assembly to the crus or the footplate of the stapes bone via a coupling element.

[0074] As described, the stimulating assembly (e.g., the stimulating assembly 160 or the stimulating assembly 260) is fixed, secured, attached, connected, or otherwise coupled to the stapes 114. In some examples, the stimulating assembly is fixed / secured to the footplate 174 of the stapes 114. In some other examples, the stimulating assembly is fixed / secured to the crus 175(A) or the crus 175(B) of the stapes 114. The stimulating assembly is fixed, secured, attached, connected, or otherwise coupled to a portion of the stapes 114 (at operation 330) via a coupling element (e.g., the coupling element 168 or the coupling element 268). For example, the coupling element can comprise one or more clips, connectors, hooks, fasteners, screws, adhesives (e.g., surgical adhesive), cements (e.g., bone cement), or the like, as described above with reference to FIGs. IB and 2B.

[0075] In some examples, method 300 can further include calibrating the vestibular stimulation device, and providing therapeutic stimulation to the vestibular system of the recipient with the vestibular stimulation device. The calibration can be performed to confirm appropriate functioning of the vestibular stimulation device or to determine whether placement of the electrodes is appropriate. For example, calibrating the vestibular stimulation device can include performing vestibular response telemetry, which can be used to confirm that one or more of the electrodes are able to provide appropriate stimulation, and / or for determining which of the one or more electrodes of the stimulating assembly are best able to stimulate target anatomy of the recipient. After calibrating the vestibular stimulation device, therapeutic stimulation can be provided according to a schedule, continuously, periodically, for a therapeutic amount of time, etc.

[0076] FIG. 4 is a flowchart illustrating one example method 400, in accordance with certain embodiments presented herein. Method 400 begins at operation 410, which includes generating one or more electrical stimulation signals. At operation 420, method 400 includes delivering, via one or more electrodes configured to be implanted in a recipient, the one or more electrical stimulation signals to a first area of a vascularized bone of a recipient. At operation 430, method 400 includes conducting (e.g., guiding / channeling), via blood vessels in the vascularized bone or in adjoining soft tissue, the one or more electrical stimulation signals from the first area of a vascularized bone to a second area of the vascularized bone in a direction of a target stimulation area of the recipient (e.g., where the blood vessels guide the stimulation signals in the target direction).

[0077] In some examples, delivering the one or more electrical stimulation signals to the vascularized bone of the recipient (operation 420) includes electrically stimulating a stapes of the recipient via the one or more electrodes. In some other example embodiments, electrically stimulating the stapes of the recipient includes electrically stimulating a footplate of the stapes via the one or more electrodes. In some other example embodiments, electrically stimulating the stapes of the recipient includes electrically stimulating a crus of the stapes via the one or more electrodes.

[0078] In some examples, method 400 can include generating the one or more electrical stimulation signals at a stimulator (e.g., based on a schedule, a program, input from another component or an external device, etc.), and transmitting the one or more electrical stimulation signals to the one or more electrodes via a lead electrically connecting the stimulator with the one or more electrodes. The generating and delivering of the one or more electrical stimulationsignals is configured to, in certain examples, treat vestibular disorders, balance disorders, tinnitus, or motor / mobility disorders, for example. The transmitting can include transmitting the one or more electrical stimulation signals through a wired connection (e.g., via the lead) or a wireless connection between the stimulator and the one or more electrodes. In some examples, the same stimulation signal is sent to all of the electrodes, or different stimulation signals can be applied to different electrodes. In some examples, certain electrodes can be selectively activated to target stimulation at a particular anatomical location (e.g., to target vestibular anatomy through the oval window).

[0079] In some examples, conducting the one or more electrical stimulation signals from the first area of a vascularized bone to a target stimulation area of the recipient (operation 430) can include stimulating vestibular tissue of the recipient. For example, the one or more electrodes can provide the stimulation to the stapes and through the oval window of the recipient using the one or more electrical stimulation signals received from the stimulator, and the vestibular tissue that is stimulated includes one or more of the vestibular canals, or one or more of the otolith organs (e.g., the utricle and / or the saccule), or one or more nerves associated with the vestibular system (e.g., the vestibulocochlear nerve).

[0080] FIG. 5 is a flowchart illustrating one example method 500 for electrical bone conduction, in accordance with certain embodiments presented herein. Method 500 begins at operation 510, which includes implanting one or more electrodes adjacent a first area of preferentially vascularized tissue in a recipient, wherein the preferentially vascularized tissue has a plurality of blood vessels directed from the first area towards a target stimulation area. At operation 520, method 500 includes delivering the electrical stimulation signals to the first area of the preferentially vascularized tissue such that plurality of blood vessels channel the electrical stimulation signals in a direction of the target stimulation area. The preferentially vascularized tissue includes blood vessels that are configured (e.g., oriented) to guide the electrical stimulation signals from the stimulation delivery point towards the target stimulation area.

[0081] In certain aspects, the techniques presented herein include identifying the preferentially vascularized tissue and / or the target stimulation area. The preferentially vascularized tissue and / or the target stimulation area could be identified, for example, using pre-surgical medical imaging and analysis thereof. In certain examples, a machine -learned algorithm is used to analysis the medical imaging to determine the preferentially vascularized tissue and / or the target stimulation area.

[0082] In certain examples, the attribute s / parameters of the electrical stimulation signals delivered to preferentially vascularized tissue can be adjusted based on the characteristics of the preferentially vascularized tissue. For example, the electrical conductivity of the preferentially vascularized tissue can change over time due to biological factors (e.g., with age, due to injury, disease, etc.), which means that the current conduction properties of the tissue might also change over time / with age. As such, in accordance with certain embodiments presented herein, a mechanism is provided to compensate for changes in the electrical conductivity of the preferentially vascularized tissue which have a biological nature, such as aging, etc.

[0083] In certain embodiments, the techniques presented can directly measure the electrical conductivity of the tissue, or can indirectly estimate / measure the electrical conductivity of the tissue by analyzing the effectiveness of the applied stimulation / therapy. In the context of an indirect measure and vestibular stimulation for a movement disorder, closed loop system could be utilized where motion sensors (e.g., accelerometers) in an implant are used to monitor the effectiveness of the applied current in treating the movement disorder. If the effectiveness of the stimulation is determined to change with time as a result of vascularization changes, then the stimulation attributes could be adjusted (e.g., increased amplitude, change frequency, etc.) to account for the electrical conductivity changes of the tissue which have a biological nature, and thereby ensure the stimulation remains effective.

[0084] In the context of a direct measure, a system could monitor one or electrical parameters, such as the electrical impedance between two electrodes. In such an example, if the electrical impedance is determined to change with time as a result of electrical conductivity changes, then the stimulation attributes could be adjusted (e.g., increased amplitude, change frequency, etc.,) to account for the electrical conductivity changes.

[0085] It is to be appreciated that above two techniques are merely illustrative of how the techniques presented herein can adjust attributes / parameters of the electrical stimulation signals delivered to preferentially vascularized tissue. As such, it is to be appreciated that other techniques could be used in accordance with the techniques presented herein to directly or indirectly adjust for changes in the electrical conductivity which have a biological nature (for example due to changes in vascularization )over time.

[0086] According to some example embodiments, the method 300, method 400, and / or the method 500 can be implemented using an apparatus, such as the vestibular stimulation device100 of FIG. 1A and / or the vestibular stimulation device 200 of FIG. 2A. The apparatus can include a stimulating assembly including one or more electrodes attached to a portion of an ossicular chain of a recipient, an implantable housing remote from the stimulating assembly, the housing having a stimulator disposed therein that is configured to deliver electrical stimulation signals to vestibular tissue of a recipient via the one or more electrodes, and a lead electrically connecting the stimulator to the one or more electrodes of the stimulating assembly.

[0087] In some examples, the stimulating assembly including the one or more electrodes is attached to a stapes bone of the ossicular chain. In one example embodiment, the stimulating assembly including the one or more electrodes is configured to be attached to a crus of the stapes bone via a coupling element, wherein the coupling element comprises one or more clips, screws, hooks, clamps, connectors, fasteners, adhesives, or cements. In some examples, the stimulating assembly is flexible to enable the stimulating assembly to conform to a shape / surface of the crus of the stapes bone. In some examples, the one or more electrodes comprises a plurality of electrodes disposed along a surface of the stimulating assembly that is configured to face the crus of the stapes bone.

[0088] In another example embodiment, the stimulating assembly including the one or more electrodes is configured to be attached to a footplate of the stapes bone via a coupling element. The coupling element can be a surgical adhesive or bone cement, for example.

[0089] In some examples, the one or more electrodes of the stimulating assembly are configured to electrically stimulate the portion of the ossicular chain of the recipient to conduct and guide electrical stimulation signals from the ossicular chain to the vestibular tissue of the recipient. In some examples, the apparatus is configured to preserve inner ear anatomy of the recipient when the stimulating assembly is implanted in the recipient.

[0090] According to certain aspects of the devices, components, and techniques described herein with reference to FIGs. 1A, IB, 1C, 2A, 2B, 3, 4, and 5, vascularized bone (e.g., the stapes) is used as an electrical conductor with the aim to stimulate the space below the oval window, for example. As the ossicular chain is heavily vascularized (meaning electrically conductive), applying current to the stapes crus will find its way to the stapes footplate. Since the stapes vein contains the electrical conductivity, it is sufficient to pass current to the target stimulation area. The principle uses the conductivity of the stapes so that current can spread from the stapes footplate to travel through the perilymph to reach the saccule on the opposite side. In other words, the stapes bone is used as an electrical pathway to indirectly stimulatethe saccule. For example, with the electrode attached to the footplate, the current will spread more easily to the fluid below the stapes footplate than through the rest of the footplate (which is bone). On the other hand, with the electrode attached to the leg (crus) of the stapes, some current can get lost and flow away from the footplate.

[0091] One benefit of this solution is that it does not affect the mobility of the stapes. Another advantage of this solution is that implantation does not harm any structures which would otherwise be needed for inserting an electrode in the perilymph. The invention provides an easy way to preserve hearing while stimulating the otolith organ (saccule) positioned below the oval window to treat vestibular disorder, which will enable a vestibular implant to stimulate the vestibular nerve without damaging hearing. As there is little overlap between hearing loss and balance disorders, the preservation of hearing is fundamental to make the vestibular disorder therapy successful.

[0092] As should be appreciated, while particular uses of the technology have been illustrated and discussed above, the disclosed technology can be used with a variety of devices in accordance with many examples of the technology. The above discussion is not meant to suggest that the disclosed technology is only suitable for implementation within systems akin to that illustrated in the figures. In general, additional configurations can be used to practice the processes and systems herein and / or some aspects described can be excluded without departing from the processes and systems disclosed herein.

[0093] 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.

[0094] 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.

[0095] According to certain aspects, systems and non-transitory computer readable storage media are provided. The systems are configured with hardware configured to executeoperations analogous to the methods of the present disclosure. The one or more non-transitory computer readable storage media comprise instructions that, when executed by one or more processors, cause the one or more processors to execute operations analogous to the methods of the present disclosure.

[0096] 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.

[0097] Although specific aspects were described herein, the scope of the technology is not limited to those specific aspects. One skilled in the art will recognize other aspects or improvements that are within the scope of the present technology. Therefore, the specific structure, acts, or media are disclosed only as illustrative aspects. The scope of the technology is defined by the following claims and any equivalents therein.

[0098] It is also to be appreciated that the embodiments presented herein are not mutually exclusive and that the various embodiments can be combined with another in any of a number of different manners.

Claims

CLAIMS1. A method comprising : surgically accessing an implantation area in a recipient; implanting a stimulating assembly of a vestibular stimulation device proximate to an ossicular chain of the recipient, wherein the stimulating assembly comprises one or more electrodes; and attaching the stimulating assembly to a portion of the ossicular chain of the recipient such that the one or more electrodes contact the portion of the ossicular chain.

2. The method of claim 1, wherein implanting the stimulating assembly includes placing the stimulating assembly at a stapes bone of the ossicular chain.

3. The method of claim 2, wherein placing the stimulating assembly at the stapes bone of the recipient comprises: placing the one or more electrodes in contact with a crus of the stapes bone; and attaching the stimulating assembly to the crus of the stapes bone via a coupling element.

4. The method of claim 3, wherein the coupling element comprises one or more of clips, screws, hooks, clamps, connectors, fasteners, adhesives, or cements.

5. The method of claim 2, wherein placing the stimulating assembly at the stapes bone of the recipient comprises: placing the one or more electrodes in contact with a footplate of the stapes bone; and attaching the stimulating assembly to the footplate of the stapes bone via a coupling element.

6. The method of claim 5, wherein the coupling element comprises one or more of clips, screws, hooks, clamps, connectors, fasteners, adhesives, or cements.

7. The method of claim 1, 2, 3, 4, 5, or 6, wherein implanting the stimulating assembly includes: creating an opening in the implantation area of the recipient;excavating ossicular chain tissue to define a location for implanting the stimulating assembly; and implanting the stimulating assembly proximate to the ossicular chain of the recipient.

8. The method of claim 1, 2, 3, 4, 5, or 6, further comprising: calibrating the vestibular stimulation device; and providing therapeutic stimulation to the recipient with the vestibular stimulation device.

9. The method of claim 8, wherein calibrating the vestibular stimulation device comprises: performing vestibular response telemetry; and determining which of the one or more electrodes of the stimulating assembly are best able to stimulate target anatomy of the recipient.

10. The method of claim 1, 2, 3, 4, 5, or 6, further comprising: delivering electrical stimulation signals to the ossicular chain via the one or more electrodes.

11. An apparatus comprising: a stimulating assembly including one or more electrodes configured to be implanted in a recipient; a coupling element configured to attach the stimulating assembly to an ossicular chain of the recipient so the one or more electrodes are in contact with the ossicular chain; an implantable housing remote from the stimulating assembly, the implantable housing having a stimulator disposed therein that is configured to deliver electrical stimulation signals to vestibular tissue of a recipient via the one or more electrodes; and a lead electrically connecting the stimulator to the one or more electrodes of the stimulating assembly.

12. The apparatus of claim 11, wherein the coupling element is configured to attach the stimulating assembly to an ossicular so that the one or more electrodes are in contact with a stapes bone of the ossicular chain.

13. The apparatus of claim 12, wherein coupling element is configured to attach the stimulating assembly to a crus of the stapes bone so the one or more electrodes are in contact with the crus.

14. The apparatus of claim 13, wherein the stimulating assembly is flexible to enable the stimulating assembly to conform to a surface shape of the crus of the stapes bone.

15. The apparatus of claim 13, wherein the one or more electrodes comprises a plurality of electrodes disposed along a surface of the stimulating assembly that is configured to face the crus of the stapes bone.

16. The apparatus of claim 12, wherein coupling element is configured to attach the stimulating assembly to a footplate of the stapes bone via a coupling element.

17. The apparatus of claim 11, 12, 13, 14, 15, or 16, wherein the coupling element comprises a surgical adhesive or bone cement.

18. The apparatus of claim 11, 12, 13, 14, 15, or 16, wherein the one or more electrodes of the stimulating assembly are configured to electrically stimulate a portion of the ossicular chain of the recipient to conduct electrical stimulation signals from the ossicular chain to the vestibular tissue of the recipient.

19. The apparatus of claim 11, 12, 13, 14, 15, or 16, wherein the coupling element comprises one or more clips.

20. The apparatus of claim 11, 12, 13, 14, 15, or 16, wherein the coupling element comprises one or more screws, hooks, clamps, connectors, or fasteners.

21. A method comprising : generating one or more electrical stimulation signals; delivering, via one or more electrodes configured to be implanted in a recipient, the one or more electrical stimulation signals to a first area of a vascularized bone of a recipient; and conducting, via one or more blood vessels in the vascularized bone or in adjoining soft tissue, the one or more electrical stimulation signals from the first area of a vascularizedbone to a second area of a vascularized bone in a direction of a target stimulation area of the recipient.

22. The method of claim 21, wherein delivering the one or more electrical stimulation signals to the first area of the vascularized bone comprises: delivering the one or more electrical stimulation signals to an ossicular chain of the recipient.

23. The method of claim 22, wherein delivering the one or more electrical stimulation signals to the ossicular chain of the recipient comprises: directly electrically stimulating a stapes of the recipient via the one or more electrodes.

24. The method of claim 23, wherein directly electrically stimulating the stapes of the recipient comprises: directly electrically stimulating a footplate of the stapes via the one or more electrodes.

25. The method of claim 23, wherein directly electrically stimulating the stapes of the recipient comprises: directly electrically stimulating a crus of the stapes via the one or more electrodes.

26. The method of claim 21, 22, 23, 24, or 25, further comprising: generating the one or more electrical stimulation signals at a stimulator unit; and providing the one or more electrical stimulation signals to the one or more electrodes via a lead electrically connecting the stimulator unit with the one or more electrodes.

27. The method of claim 21, 22, 23, 24, or 25, wherein delivering the one or more electrical stimulation signals is configured to treat vestibular disorders, balance disorders, tinnitus, or motor / mobility disorders.

28. The method of claim 21, wherein the second area of the bone is in contact with at least one of conductive body tissue or fluid proximate to the target stimulation area.

29. The method of claim 21, wherein the second area of the bone is proximate to the target stimulation area.

30. A method comprising: implanting one or more electrodes adjacent a first area of preferentially vascularized tissue in a recipient, wherein the preferentially vascularized tissue has a plurality of blood vessels directed from the first area towards a target stimulation area; and delivering, via the one or more electrodes, electrical stimulation signals to the first area of the preferentially vascularized tissue such that plurality of blood vessels channel the electrical stimulation signals in a direction of the target stimulation area.

31. The method of claim 30, further comprising: attaching the one or more electrodes to the first area of the preferentially vascularized tissue such that the one or more electrodes abut the first area.

32. The method of claim 30 or 31, wherein implanting the one or more electrodes includes: placing the one or more electrodes adjacent a stapes bone of the recipient.

33. The method of claim 32, wherein placing the one or more electrodes adjacent the stapes bone of the recipient comprises: placing the one or more electrodes in contact with a crus of the stapes bone; and securing the one or more electrodes to the crus of the stapes bone.

34. The method of claim 33, wherein the one or more electrodes are part of a stimulating assembly, and wherein securing the one or more electrodes to the crus of the stapes bone comprises: attaching the stimulating assembly to the crus of the stapes bone via a coupling element.

35. The method of claim 34, wherein the coupling element comprises one or more of clips, screws, hooks, clamps, connectors, fasteners, adhesives, or cements.

36. The method of claim 32, wherein placing the one or more electrodes adjacent the stapes bone of the recipient comprises: placing the one or more electrodes in contact with a footplate of the stapes bone; and securing the one or more electrodes to the footplate of the stapes bone.

37. The method of claim 36, wherein the one or more electrodes are part of a stimulating assembly, and wherein securing the one or more electrodes to the footplate of the stapes bone comprises: attaching the stimulating assembly to the footplate of the stapes bone via a coupling element.

38. The method of claim 37, wherein the coupling element comprises one or more of clips, screws, hooks, clamps, connectors, fasteners, adhesives, or cements.

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