System and method for guided stimulation to tissue

Abstract

An apparatus includes an elongate member having a distal end portion configured to be inserted into a recipient and at least one electrode on the distal end portion. The at least one electrode is configured to apply an electrical signal to tissue at a location within the recipient. The apparatus further includes at least one tissue marker on the distal end portion. The at least one tissue marker is configured to generate an indication of the location. The indication is configured to be accessed by an entity performing a subsequent surgical procedure during the subsequent surgical procedure.

Description

COCLR.094WO PCT APPLICATION SYSTEM AND METHOD FOR GUIDED STIMULATION TO TISSUEBACKGROUNDField

[0001] The present application relates generally to systems and methods for suppressing the effects of tinnitus on a recipient.Description of the Related Art

[0002] Medical devices are devices that are intended to be used for medical purposes. They can vary in both their intended use and indications for use. Examples range from simple, low-risk medical supplies, such as tongue depressors, medical thermometers, disposable gloves, and bedpans, to complex, potentially high-risk devices that are implanted and / or sustain life, such as deep brain stimulators and cardiac stents. Other categories of medical devices include diagnostic equipment, such as x-ray machines and ultrasound scanners, life support equipment, such as mechanical ventilators and dialysis machines.

[0003] Hearing devices act on an actual or potential auditory 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 devices, etc.) or 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.SUMMARY

[0004] In one aspect disclosed herein, an apparatus comprises an elongate member having a distal end portion configured to be inserted into a recipient. The apparatus further comprises at least one electrode on the distal end portion. The at least one electrode is configured to apply an electrical signal to tissue at a location within the recipient. The apparatus further comprises at least one tissue marker on the distal end portion. The at leastone tissue marker is configured to generate an indication of the location. The indication is configured to be accessed by an entity performing a subsequent surgical procedure during the subsequent surgical procedure.

[0005] In another aspect disclosed herein, an apparatus comprises a needle configured to be inserted into a recipient and at least one electrode at a distal end portion of the needle. The at least one electrode is configured to apply a therapeutic stimulation to tissue at a location within the recipient. The distal end portion is configured to be detected by an imaging system configured to detect a position and / or an orientation of the distal end portion and to generate a virtual indication of the location. The virtual indication is configured to be accessed by an entity performing a subsequent surgical procedure during the subsequent surgical procedure.

[0006] In another aspect disclosed herein, a method comprises inserting a stimulator into a recipient. The method further comprises using the stimulator to stimulate tissue at a location within the recipient. The method further comprises generating an indication of the location. The method further comprises removing the stimulator from the recipient, wherein the indication is accessible during a surgical procedure performed after said removing the stimulator from the recipient.

[0007] In another aspect disclosed herein, a method comprises detecting a previously-generated indication of a location within a recipient. The method further comprises surgically implanting at least one electrode at the location.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Implementations are described herein in conjunction with the accompanying drawings, in which:

[0009] FIG. 1 is a perspective view of an example cochlear implant auditory prosthesis implanted in a recipient in accordance with certain embodiments described herein;

[0010] FIGs. 2A and 2B schematically illustrate an example apparatus and an example result of usage of the apparatus, respectively, in accordance with certain implementations described herein;

[0011] FIG. 2C schematically illustrates an example implant comprising a stimulation element affixed to the location in accordance with certain implementations described herein;

[0012] FIGs. 3A-3G schematically illustrate various cross-sectional views of the apparatus in accordance with certain implementations described herein; and

[0013] FIGs. 4 A and 4B are flow diagrams of two example methods in accordance with certain implementations described herein.DETAILED DESCRIPTION

[0014] Tinnitus is an auditory phantom process, which may be perceived as having various characteristics (e.g., pure tone; narrow band noise; polyphonic) and experienced either unilaterally or bilaterally. Masking has previously been used to treat tinnitus, with either audible or electrical stimulation at a consistent level. Masking can comprise adding a masking stimulus (e.g., signals) corresponding to sound (e.g., white noise; music; patterned sound; low-level sound; sound tailored based on characteristics of the recipient’s tinnitus) to the sound from the ambient auditory environment in order to mask or cover up the phantom sound (e.g., ringing; hissing) due to tinnitus. The added sound level can be close to or louder than the perceived loudness of the phantom sound. While the tinnitus can be partially or fully masked by the added sound such that the recipient’s perception of the phantom sound is reduced, masking does not reduce or eliminate the tinnitus itself. In a loud auditory environment, masking may be easily achieved, but in more quiet auditory environments, the consistent level of auditory stimulation used in masking may be undesirable. In addition, in some cases, the perception of tinnitus is intermittent or variable in magnitude.

[0015] Certain implementations described herein provide a system and method for providing an entity (e.g., clinician; surgeon; robotic surgical system) with guidance during implantation surgery (e.g., tinnitus implant implantation surgery) as to where to place a stimulation element (e.g., implant electrode) following a pre-operative test to determine an efficacious location for placing the stimulation element. The pre-operative test can be performed by inserting a stimulator (e.g., transtympanic needle) into the recipient and using the stimulator to apply stimulation signals to a location. The stimulator can also be configured to mark or otherwise make the efficacious location identifiable to the entity that will be implanting the stimulation element during a surgical procedure that is separate from and subsequent to the pre-operative test.

[0016] Besides tinnitus treatment (e.g., management) devices, there are a number of other different types of devices in / with which the techniques presented herein can beimplemented. Merely for ease of description, the techniques presented herein are primarily described with reference to a specific device. 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 or systems, including consumer electronic devices (e.g., consumer hearing devices, consumer computing devices such as mobile phones and tablets, audio equipment such as home theatre and car audio systems, etc.), computing systems (e.g., servers in data centers, Internet-of-Things (loT) devices), various types of software systems, such as databases, machine learning and artificial intelligence systems, other medical devices, such as diagnostic equipment or life sustaining equipment, etc. For example, the techniques presented herein could be used in or with sensory protheses, including hearing aids and cochlear implants, and various medical devices, such as pacemakers, drug delivery systems, implantable defibrillators, functional electrical stimulation devices, sleep disorder devices (e.g., sleep apnea devices), seizure devices (e.g., devices for monitoring and / or treating epileptic events), balance or movement disorder devices (e.g., vestibular stimulation devices), visual implants (e.g., bionic eyes), etc.

[0017] The teachings detailed herein are applicable, in at least some implementations, to any type of implantable stimulation and / or measurement system or device (e.g., implantable tinnitus treatment device or system). Implementations can include any type of medical device that can utilize the teachings detailed herein and / or variations thereof. Furthermore, while certain implementations are described herein in the context of tinnitus treatment (e.g., management) devices, certain other implementations are compatible in the context of other types of devices or systems comprising electrodes implanted on or within a recipient’s body.

[0018] Merely for ease of description, apparatus and methods disclosed herein are primarily described with reference to an illustrative medical device, namely an implantable tinnitus treatment assembly, but the apparatus and methods disclosed herein can alternatively be used with transducer assemblies including but not limited to: electro-acoustic electrical / acoustic systems, cochlear implant devices, implantable hearing aid devices, middle ear implant devices, bone conduction devices (e.g., active bone conduction devices; passive bone conduction devices, percutaneous bone conduction devices; transcutaneous bone conduction devices), Direct Acoustic Cochlear Implant (DACI), middle ear transducer (MET),electro- acoustic implant devices, other types of auditory prosthesis devices, and / or combinations or variations thereof, or any other suitable hearing prosthesis system with or without one or more external components. Implementations can include any type of auditory prosthesis that can utilize the teachings detailed herein and / or variations thereof. Certain such implementations can be referred to as “partially implantable,” “semi-implantable,” “mostly implantable,” “fully implantable,” or “totally implantable” auditory prostheses. In some implementations, the teachings detailed herein and / or variations thereof can be utilized in other types of prostheses beyond auditory prostheses.

[0019] While certain implementations are described herein in the context of tinnitus treatment devices, certain other implementations are compatible in the context of various types of sensory (e.g., auditory) prosthesis systems that are configured to evoke corresponding types of neural or sensory (e.g., hearing, sight, tactile, smell, taste) percepts are compatible with certain implementations described herein, including but are not limited to: vestibular devices (e.g., vestibular implants), visual devices (e.g., bionic eyes), visual prostheses (e.g., retinal implants), somatosensory implants, and chemosensory implants. Certain other implementations are compatible with other types of medical devices that can utilize the teachings detailed herein and / or variations thereof to provide a wide range of therapeutic benefits to recipients, patients, or other users (e.g., epilepsy monitoring systems; pain control systems; bladder control systems; sleep apnea control systems; neurostimulators; pacemakers), to perform monitoring or measuring functionalities (e.g., electroencephalogram monitoring of brain function; electrocardiogram monitoring of heart function), or other medical implants comprising a rechargeable implanted power source. Certain other implementations are compatible with other non-medical devices or system (e.g., consumer electronic devices).

[0020] FIG. 1 is a perspective view of an example implant 100 implanted in a recipient in accordance with certain implementations described herein. As shown in FIG. 1, the recipient has an outer ear 101, a middle ear 105, and an inner ear 107. In a fully functional ear, the outer ear 101 comprises an auricle 110 and an ear canal 102. An acoustic pressure or sound wave 103 is collected by the auricle 110 and is channeled into and through the ear canal 102. Disposed across the distal end of the ear canal 102 is a tympanic membrane 104 which vibrates in response to the sound wave 103. This vibration is coupled to oval window orfenestra ovalis 112 through three bones of middle ear 105, collectively referred to as the ossicles 106 and comprising the malleus 108, the incus 109, and the stapes 111. The bones 108, 109, and 111 of the middle ear 105 serve to filter and amplify the sound wave 103, causing the oval window 112 to articulate, or vibrate in response to vibration of the tympanic membrane 104. This vibration sets up waves of fluid motion of the perilymph within cochlea 140. Such fluid motion, in turn, activates tiny hair cells (not shown) inside the cochlea 140. Activation of the hair cells causes appropriate nerve impulses to be generated and transferred through the spiral ganglion cells (not shown) and auditory nerve 114 to the brain (also not shown) where they are perceived as sound.

[0021] The example implant 100 of FIG. 1 is a cochlear implant auditory prosthesis configured to apply stimulation signals to a portion of the recipient’s ear which can provide a hearing percept to the recipient. The cochlear implant auditory prosthesis of the example implant 100 shown in FIG. 1 comprises an implanted stimulator unit 120 (e.g., an actuator) and an external microphone assembly 124 (e.g., a partially implantable cochlear implant). An example implant 100 (e.g., a mostly, fully, or totally implantable cochlear implant) in accordance with certain implementations described herein can replace the externally disposed microphone assembly 124 shown in FIG. 1 with a subcutaneously implantable assembly comprising an acoustic transducer (e.g., microphone). Such microphone assemblies are configured to be positioned (e.g., in a surgical procedure) beneath the skin and on, within, or proximate to the recipient’s skull and at a location that facilitates the receipt of acoustic signals by the microphone assembly once implanted (e.g., at a location between the recipient’s skin and skull, rearward and upward of the recipient’s ear or in the mastoid region). In certain implementations, the example implant 100 of FIG. 1 can be in conjunction with a reservoir of liquid medicament.

[0022] As shown in FIG. 1, the example implant 100 comprises one or more components which are temporarily or permanently implanted in the recipient. The example implant 100 is shown in FIG. 1 with an external component 142 which is directly or indirectly attached to the recipient’s body, and an internal component 144 which is temporarily or permanently implanted in the recipient (e.g., positioned in a recess of the temporal bone adjacent auricle 110 of the recipient). The external component 142 typically comprises one or more sound input elements (e.g., an external microphone 124) for detecting sound, a soundprocessing unit 126 (e.g., disposed in a Behind-The-Ear unit), a power source (not shown), and an external transmitter unit 128. In the illustrative implementation of FIG. 1, the external transmitter unit 128 comprises an external coil 130 (e.g., a wire antenna coil comprising multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire) and, preferably, a magnet (not shown) secured directly or indirectly to the external coil 130. The external coil 130 of the external transmitter unit 128 is part of an inductive radio frequency (RF) communication link with the internal component 144. The sound processing unit 126 processes the output of the microphone 124 that is positioned externally to the recipient’s body, in the depicted implementation, by the recipient’s auricle 110. The sound processing unit 126 generates encoded signals, sometimes referred to herein as encoded data signals, which are provided to the external transmitter unit 128 (e.g., via a cable). As will be appreciated, the sound processing unit 126 can utilize digital processing techniques to provide frequency shaping, amplification, compression, and other signal conditioning, including conditioning based on recipient-specific fitting parameters.

[0023] The power source of the external component 142 is configured to provide power to the implant 100, where the implant 100 includes a battery (e.g., located in the internal component 144, or disposed in a separate implanted location) that is recharged by the power provided from the external component 142 (e.g., via a transcutaneous energy transfer link). The transcutaneous energy transfer link is used to transfer power and / or data to the internal component 144 of the implant 100. Various types of energy transfer, such as infrared (IR), electromagnetic, capacitive, and inductive transfer, may be used to transfer the power and / or data from the external component 142 to the internal component 144. During operation of the implant 100, the power stored by the rechargeable battery is distributed to the various other implanted components as needed.

[0024] The internal component 144 comprises an internal receiver unit 132, a stimulator unit 120, and an elongate stimulation assembly 118. In some implementations, the internal receiver unit 132 and the stimulator unit 120 are hermetically sealed within a biocompatible housing. The internal receiver unit 132 comprises an internal coil 136 (e.g., a wire antenna coil comprising multiple turns of electrically insulated single-strand or multistrand platinum or gold wire), and preferably, a magnet (also not shown) fixed relative to the internal coil 136. The internal receiver unit 132 and the stimulator unit 120 are hermeticallysealed within a biocompatible housing, sometimes collectively referred to as a stimulator / receiver unit. The internal coil 136 receives power and / or data signals from the external coil 130 via a transcutaneous energy transfer link (e.g., an inductive RF link). The stimulator unit 120 generates electrical stimulation signals based on the data signals, and the stimulation signals are delivered to the recipient via the stimulation assembly 118.

[0025] The stimulation assembly 118 has a proximal end connected to the stimulator unit 120, and a distal end implanted in the cochlea 140. The stimulation assembly 118 extends from the stimulator unit 120 to the cochlea 140 through the mastoid bone 119. In some implementations, the stimulation assembly 118 can be implanted at least in the basal region 116, and sometimes further. For example, the stimulation assembly 118 can extend towards apical end of the cochlea 140, referred to as the cochlea apex 134. In certain circumstances, the stimulation assembly 118 may be inserted into the cochlea 140 via a cochleostomy 122. In other circumstances, a cochleostomy may be formed through the round window 121, the oval window 112, the promontory 123, or through an apical turn 147 of the cochlea 140.

[0026] The stimulation assembly 118 comprises a longitudinally aligned and distally extending array 146 (e.g., electrode array; contact array) of stimulation elements 148 (e.g., electrical electrodes; electrical contacts; optical emitters; optical contacts). The stimulation elements 148 can be longitudinally spaced from one another along a length of the body of the stimulation assembly 118. For example, the stimulation assembly 118 can comprise an array 146 comprising twenty-two (22) stimulation elements 148 that are configured to deliver stimulation to the cochlea 140. Although the stimulation elements 148 of the array 146 can be disposed on the stimulation assembly 118, in most practical applications, the array 146 is integrated into the stimulation assembly 118 (e.g., the stimulation elements 148 of the array 146 are disposed in the stimulation assembly 118). As noted, the stimulator unit 120 generates stimulation signals (e.g., electrical signals; optical signals) which are applied by the stimulation elements 148 to the cochlea 140, thereby stimulating the auditory nerve 114.

[0027] While FIG. 1 schematically illustrates an example implant 100 utilizing an external component 142 comprising an external microphone assembly 124, an external sound processing unit 126, and an external power source, in certain other implementations, one ormore of the microphone assembly 124, sound processing unit 126, and power source are implantable on or within the recipient (e.g., within the internal component 144). For example, the implant 100 can have each of the microphone assembly 124, sound processing unit 126, and power source implantable on or within the recipient (e.g., encapsulated within a biocompatible assembly located subcutaneously), and can be referred to as a totally implantable cochlear implant (“TICI”). For another example, the implant 100 can have most components of the cochlear implant (e.g., excluding the microphone, which can be an in-the-ear-canal microphone) implantable on or within the recipient, and can be referred to as a mostly implantable cochlear implant (“MICI”).

[0028] While FIG. 1 schematically illustrates an example implant 100 comprising a cochlear implant auditory prosthesis, in certain implementations, the implant 100 comprises a vestibular implant (e.g., balance prosthesis) configured to suppress (e.g., reduce; mask; treat) the effects of vertigo experienced by the recipient (see, e.g., Int’l Publ. No. WO 2021 / 038355A) or a tinnitus implant configured to suppress (e.g., reduce; mask; treat) the effects of tinnitus experienced by the recipient (see, e.g., J.P. Marinelli et al., “Electrical stimulation of the cochlea for treatment of chronic disabling tinnitus: an open-label trail towards the development of an implantable device,” J. Translational Medicine, 20:56 (2022)). The vestibular or tinnitus implant can include various components similar to those of the cochlear implant auditory prosthesis (e.g., implanted stimulator unit 120; external component 142; internal component 144; stimulation assembly 118), but instead of providing stimulation signals configured to provide a hearing percept to the recipient, the components of the vestibular or tinnitus implant are configured to suppress (e.g., reduce; mask; treat) the effects of vertigo or tinnitus (e.g., moderate to severe effects) experienced by the recipient. For example, instead of the stimulation assembly 118 comprising an array 146 of stimulation elements 148 (e.g., electrodes) configured to be inserted into the cochlea 140, the stimulation assembly 118 of the implant 100 can comprise at least one stimulation element 148 (e.g., electrode) configured to be affixed to the promontory 123 and to apply electrical stimulation signals (e.g., biphasic charge balance electrical stimulation) to the promontory 123 to suppress (e.g., reduce; mask; treat) the unwanted effects of vertigo or tinnitus experienced by the recipient.

[0029] In certain implementations, the implant 100 is a component of an implantable (e.g., fully implantable or partially implantable) or non-implantable auditory prosthesis system, examples of which include but are not limited to: a cochlear implant system, a bone conduction implant system (e.g., active bone conduction system; passive bone conduction system, percutaneous bone conduction system; transcutaneous bone conduction system), a hearing aid system, a Direct Acoustic Cochlear Implant (DACI) system, a middle ear implant system, a middle ear transducer (MET) system, an electro-acoustic implant system, another type of auditory prosthesis system, and / or combinations or variations thereof, or any other suitable hearing prosthesis system with or without one or more external components. For example, U.S. Pat. Appl. Publ. No. 2017 / 0347213 discloses a tinnitus relief system combined with a cochlear implant system compatible with certain implementations described herein. Implementations can include any type of auditory prosthesis that can utilize the teachings detailed herein and / or variations thereof.

[0030] In certain implementations, prior to implantation of the implant 100, a preoperative promontory stimulator system is used to assess whether electrical stimulation signals are able to suppress the unwanted effects for the recipient. The promontory stimulator system can comprise a cochlear implant (not shown) with a first extracochlear electrode (e.g., ECE1) used as a stimulating electrode and a second extracochlear electrode (e.g., ECE2) used as a reference electrode. The promontory stimulator system can further comprise an electrically conductive transtympanic needle in electrical communication with the first extracochlear electrode. The needle is configured to be inserted through the tympanic membrane 104 of the recipient to contact the promontory 123 and to apply electrical stimulation signals to the promontory 123. Examples of electrically conductive transtympanic needles include but are not limited to: the 902-DMG75-TP TECA® disposable monopolar EMG needle electrode available from Natus Medical Inc. of Middleton, WI. Recipients that experience suppression of the unwanted effects due to the electrical stimulation signals applied by the promontory stimulator system can be considered to be eligible to receive the implant 100.

[0031] During the surgical implantation procedure for the implant 100, a recess (e.g., well) is formed (e.g., drilled) into the promontory 123 and a stimulation electrode of the implant 100 is placed on or within the recess and in electrical communication with thepromontory 123. However, during the surgical implantation procedure, there can be a lack of guidance regarding which location on the promontory 123 was tested preoperatively using the promontory stimulator system. The uncertainty of the location at which the needle contacted the promontory 123 during the preoperative assessment relative to the location at which the recess formed during the surgical procedure (also the location of the stimulation electrode) can result in inconsistent clinical benefits (e.g., reduction; increase) provided by the implant 100 to the recipient, as compared to the expected clinical benefit deduced from the preoperative use of the promontory stimulator system.

[0032] FIGs. 2A and 2B schematically illustrate an example apparatus 200 (e.g., promontory stimulator system) and an example result of usage of the apparatus 200, respectively, in accordance with certain implementations described herein. The apparatus 200 comprises an elongate member 210 having a distal end portion 212 configured to be inserted into a recipient. The apparatus 200 further comprises at least one electrode 220 on the distal end portion 212. The at least one electrode 220 is configured to apply electrical signals to tissue at a location 222 within the recipient. The apparatus 200 further comprises at least one tissue marker 230 on the distal end portion 212. The at least one tissue marker 230 is configured to generate an indication 232 of the location 222, the indication 232 configured to be accessed by an entity performing a subsequent surgical procedure during the subsequent surgical procedure.

[0033] In certain implementations, the member 210 comprises a needle configured to be inserted into the recipient’s body (e.g., by the entity performing the pre-operative test procedure). The needle can have an outer diameter in a range of 0.1 mm to 0.5 mm and a distal end portion 212 of the needle can be sufficiently sharp to facilitate penetration of the needle through intervening tissue of the recipient’s body. While FIG. 2A shows an example implementation in which the distal end portion 212 has a sharp edge or point displaced from a center longitudinal axis of the needle, in other implementations, the distal end portion 212 can have a sharp edge or point coincident with the center longitudinal axis of the needle. As schematically illustrated by FIG. 2A, the member 210 can comprise a transtympanic needle configured to be inserted through and penetrate the tympanic membrane 104 of the recipient. The transtympanic needle can be configured to contact the tissue at the location 222 within the recipient’s body at which the electrical signals are applied, which can comprise a cochlearpromontory 123 of the recipient’s body. Examples of transtympanic needles compatible with certain implementations described herein include but are not limited to the TECA® Elite Disposable Monopolar EMG Needle Electrode, the Dantec® DCN Disposable Concentric EMG Needle Electrode, and the Bo-ject® DHN Disposable Hypodermic Injectable Needle Electrode available from Natus Medical Inc. of Middleton, WI.

[0034] In certain implementations, the at least one electrode 220 can comprise an electrically conductive portion of the distal end portion 212 of the member 210. For example, the needle can comprise an electrically conductive material (e.g., metal; stainless steel; platinum; tungsten) extending from a external portion of the needle (e.g., which remains outside the recipient’s body) to the distal end portion 212 of the needle (e.g., which is inserted into the recipient’s body and placed in contact with the tissue) such that the electrical signals are transmitted along the needle from outside the recipient’s body to the distal end portion 212 within the recipient’s body and to the tissue (e.g., cochlear promontory 123). The needle can comprise an electrically insulative coating (e.g., PTFE) over the electrically conductive material, the electrically insulative coating extending along a length of the needle to electrically insulate most of the needle (e.g., except for the distal end portion 212) from the surrounding tissue of the recipient’s body. In certain implementations, the electrically insulative coating is configured to reduce mechanical friction between the needle and the intervening tissue through which the needle extends.

[0035] In certain implementations, the electrical signals applied to the tissue by the at least one electrode 220 positioned at the location 222 within the recipient are configured to electrically stimulate the tissue at the location 222 to induce a response by the recipient. This response can be used as a pre-operative test of whether the recipient would benefit from a medical implant 100 that would be subsequently surgically implanted (e.g., during a separate session) so as to provide electrical signals for treatment (e.g., therapy) of a malady, to determine the location 222 at which the application of the electrical signals has the greatest efficacious effect in treating the malady, and / or to determine the location 222 at which the risks of unwanted effects are reduced (e.g., prevented; avoided; minimized). For example, the electrical signals applied by the at least one electrode 220 at the distal end portion 212 can be configured to electrically stimulate the cochlear promontory 123 to reduce (e.g., prevent; avoid; minimize) a perception by the recipient of tinnitus (e.g., to maximize the tinnitussuppression). The electrical signals can comprise a masking stimulus (e.g., having an amplitude-frequency distribution, timing profile, duty cycle, and / or spectral content configured to mask the perceived effects of tinnitus). The electrical signals can be configured to be used by the entity performing the pre-operative test procedure (e.g., clinician; surgeon; robotic testing system) to assess whether the recipient would benefit from a tinnitus implant 100 configured to apply such electrical signals to the tissue, to determine the location 222 at which the electrical signals have the greatest efficacious effect in treating the tinnitus, and / or to determine the location 222 at which the probability of facial or chorda tympani nerve stimulation by the electrical signals are reduced (e.g., prevented; avoided; minimized).

[0036] In certain implementations, the at least one tissue marker 230 is configured to modify the tissue to generate the indication 232 at the location 222 at which the electrical signals are applied (e.g., by the distal end portion 212 in contact with the tissue) and / or at a second location 224 having a predetermined spacing and orientation relative to the location 222. The at least one tissue marker 230 can be configured to be selectively triggered by the entity performing the pre-operative test procedure (e.g., clinician; surgeon; robotic testing system) to generate the indication 232 upon the entity performing the pre-operative test procedure determining that the electrical signals being applied by the apparatus 200 at the location 222 are indicative of the location 222 being a suitable position for the electrode of the implant 100 in a subsequent implantation procedure. In certain implementations in which the indication 232 is displaced from the location 222 (e.g., at the second location 224), the indication 232 can have a shape (e.g., arrow-shaped) configured to indicate the position of the location 222 relative to the position of the indication 232 (e.g., the second location 224).

[0037] For example, the at least one tissue marker 230 can comprise at least one light source configured to emit light configured to damage (e.g., superficially damage; ablate; mark; char; cauterize) a portion of tissue, the damaged tissue serving as the indication 232 at the location 222 and / or at the second location 224 displaced laterally from the location 222. As schematically illustrated by FIG. 2A, the at least one light source comprises at least one optical waveguide 234 extending along the member 210 and configured to receive light 236 from a laser (not shown), to transmit the light 236 (e.g., visible; wavelength in a range of 450 nm to 520 nm; infrared; near-infrared; wavelength in a range of 650 nm to 1350 nm) to the distal end portion 212, and to emit the light 236 from the distal end portion 212 (e.g., from atleast one end surface of the at least one optical waveguide 234). The indication 232 (e.g., the damaged tissue) can remain visibly distinct from surrounding tissue at least until the subsequent surgical procedure during which the implant 100 is to be implanted so that an entity (e.g., clinician; surgeon; robotic surgical system) performing the subsequent surgical procedure can identify (e.g., visually) the location 222.

[0038] FIGs. 3A-3G schematically illustrate various cross-sectional views of the apparatus 200 in accordance with certain implementations described herein. FIG. 3A shows a cross-sectional view of an example apparatus 200 in a plane parallel to a center longitudinal axis of the member 210 and FIG. 3B shows a cross-sectional view of the example apparatus 200 in a plane perpendicular to the center longitudinal axis. In FIGs. 3A-3B, a single optical waveguide 234 extends through a channel of the member 210 and is substantially coincident with the center longitudinal axis. In FIGs. 3C-3D, another example apparatus 200 has a single optical waveguide 234 that extends along an outside surface of the member 210 and is substantially parallel to the center longitudinal axis. The optical waveguide 234 of FIGs. 3C-3D can be affixed to the member 210 by epoxy 412 (e.g., glue; cement). Examples of optical waveguides 234 compatible with certain implementations described herein include optical fibers having a diameter in a range of 100 microns to 300 microns and can comprise one or more materials selected from the group consisting of: silica (e.g., doped with germanium, thulium, or fluorine; fluorozirconate or fluoroaluminate glass; plastic; PMMA; polycarbonate; fluorinated polymers. The optical fibers can have a coating of acrylate or polyimde.

[0039] FIG. 3E schematically illustrates another example apparatus 200 having a single optical waveguide 234 within the outer surface of the member 210 but displaced from and substantially parallel to the center longitudinal axis. FIG. 3F schematically illustrates another example apparatus 200 having a single optical waveguide 234 that extends through a channel (e.g., groove) at the outside surface of the member 210 and that is substantially parallel with the center longitudinal axis. While FIG. 3F shows the optical waveguide 234 being held onto the member without epoxy 414, in certain other implementations, epoxy 414 can be used.

[0040] While each of the example apparatus 200 of FIGs. 3A-3F comprises a single optical waveguide 234, in certain other implementations, the apparatus 200 comprises a plurality of optical waveguides 234 (e.g., 2, 3, 4, or more). For example, FIG. 3G schematically illustrates cross-sectional views of three example apparatus 200 having threeoptical waveguides 234 in accordance with certain implementations described herein. One or more of the optical waveguides 234 can be within the outer surface of the member 210 but displaced from the center longitudinal axis, extending through a channel (e.g., groove) at the outside surface of the member 210, or extending along the outside surface of the member 210.

[0041] While the members 210 and the optical waveguides 234 of FIGs. 3A-3G are substantially straight and extend substantially parallel to the center longitudinal axis, in certain other implementations, the at least one optical waveguide 234 can have a spiral shape encircling the center longitudinal axis. While the members 210 and the optical waveguides 234 of FIGs. 3A-3G have circular cross-sectional shapes in the plane perpendicular to the center longitudinal axis, other shapes (e.g., square; rectangular; oval; regular; irregular) are also compatible with certain implementations described herein.

[0042] While FIGs. 2A and 3A-3F schematically illustrate various example apparatus 200 in which the at least one tissue marker 230 comprises at least one optical waveguide 234, in certain other implementations, other types of tissue markers 230 can be used. For example, the at least one tissue marker 230 can comprise at least one fluid conduit extending along the member 210 and configured to receive dye (e.g., ink) from a reservoir (not shown), to transmit the dye to the distal end portion 212, and to emit the dye from the distal end portion 212. For example, the at least one fluid conduit can comprise an orifice (e.g., nozzle) configured to deposit (e.g., squirt) the dye onto a portion of the tissue, the dyed tissue serving as the indication 232 at the location 222 and / or at the second location 224 displaced laterally from the location 222. For another example, the at least one fluid conduit can have an end portion configured to be pressed against the portion of the tissue to deposit (e.g., dab) the dye onto the portion of the tissue (e.g., the at least one tissue marker 230 comprising a surgical pen or squeeze ball). The indication 232 (e.g., tissue marked by the dye) can remain visibly distinct from surrounding tissue at least until the subsequent surgical procedure during which the implant 100 is to be implanted so that an entity (e.g., clinician; surgeon; robotic surgical system) performing the subsequent surgical procedure can identify (e.g., visually) the location 222. The dye can have an appearance that is distinctive from the tissue by the naked eye (e.g., black; gentian violet; methylene blue; patent blue; toluidine blue; trypan blue; ; blue; indocyanine green; green; fluorescent; radiopaque; indigo carmine; lipiodol). In certain implementations, the dye is configured to be imaged by an imaging system (e.g., utilizingx-rays, ultrasound, or other modality; a video or 3D scanning system such as a computer tomography scanning system). For example, the dye can comprise a contrast agent configured to be seen in pre-operative imaging using the imaging system. In certain such implementations, the dye is also visible to the naked eye during the subsequent surgical procedure, while in certain other implementations, the dye is not visible to the naked eye during the subsequent surgical procedure.

[0043] For another example, the at least one tissue marker 230 can comprise at least one resistive heater configured to apply heat a portion of the tissue at the location 222 and / or at the second location 224. The applied heat can be sufficient to thermally damage (e.g., superficially thermally damage; ablate; mark; char; cauterize) the portion of the tissue. The at least one resistive heater can be in thermal communication with a thermally conductive material that is configured to contact the portion of the tissue. For example, the at least one resistive heater can be in thermal communication with the distal end portion 212 of the member 210 such that the distal end portion 212 both applies the electrical signals to the portion of tissue at the location 222 and applies the heat to thermally damage the portion of tissue at the location 222. The indication 232 (e.g., damaged tissue) can remain visibly distinct from surrounding tissue at least until the subsequent surgical procedure during which the implant 100 is to be implanted so that an entity (e.g., clinician; surgeon; robotic surgical system) performing the subsequent surgical procedure can identify (e.g., visually) the location 222.

[0044] For another example, the at least one tissue marker 230 can comprise at least one detachable portion (e.g., tag; fiducial) of the member 210, the at least one detachable portion configured to controllably detach from the member 210 (e.g., in response to a trigger initiated by the entity performing the pre-operative test procedure) and to adhere (e.g., using adhesive or anchor mechanism) to the portion of the tissue at the location 222 and / or at the second location 224. The indication 232 (e.g., the at least one detachable portion affixed to the tissue) can be configured to remain adhered to the portion of the tissue at least until the subsequent surgical procedure during which the implant 100 is to be implanted so that an entity (e.g., clinician; surgeon; robotic surgical system) performing the subsequent surgical procedure can identify (e.g., visually) the location 222.

[0045] For another example, the at least one tissue marker 230 can comprise at least one cutting tool (e.g., drill bit; end mill; abrasive substance), the cutting tool configured tocontrollably mechanically deform (e.g., abrade; remove) a portion of the tissue at the location 222 and / or at the second location 224. For example, the at least one tissue marker 230 can comprise a piezoelectric element and an abrasive surface in mechanical communication with the piezoelectric element and configured to be placed in contact with the portion of the tissue. The piezoelectric element can be configured to vibrate while the abrasive surface is in contact with the portion of the tissue so as to mechanically deform the portion of tissue. The indication 232 (e.g., mechanically deformed tissue) can remain visibly distinct from surrounding tissue at least until the subsequent surgical procedure during which the implant 100 is to be implanted so that an entity (e.g., clinician; surgeon; robotic surgical system) performing the subsequent surgical procedure can identify (e.g., visually) the location 222.

[0046] For another example, the at least one tissue marker 230 can be configured to generate a virtual indication 232 (e.g., an indication 232 that does not comprise a modified portion of the tissue; a computer-generated indication) rather than a physical indication 232 (e.g., an indication that comprises a modified portion of the tissue) indicative of the location 222. The virtual indication 232 is configured to be accessed by the entity performing the subsequent surgical procedure during the subsequent surgical procedure during which the implant 100 is to be implanted to identify the location 222.

[0047] In certain implementations, the at least one tissue marker 230 is configured to be detected by an imaging system configured to image a portion of tissue within the recipient (e.g., utilizing x-rays, ultrasound, or other modality; a video or 3D scanning system such as a computer tomography scanning system). The imaging system can be configured to be triggered (e.g., by the entity performing the pre-operative test upon determining that the at least one electrode 220 is at a location 222 at which the electrical signals are efficacious) to generate and store (e.g., in a computer-readable memory) a virtual indication 232 of the location 222 relative to at least one tissue landmark within the recipient. The stored virtual indication 232 can later be accessed so as to communicate the location 222 to an entity (e.g. clinician; surgeon; robotic surgical system) conducting the subsequent surgical procedure (e.g., while the subsequent surgical procedure to implant the stimulation element 148 of the implant 100 is being conducted).

[0048] For example, the at least one tissue marker 230 can comprise a first circuit (e.g., coil; RF antenna; RFID tag) and the imaging system can comprise a second circuitconfigured to respond to the first circuit by recording a position and / or an orientation of the first circuit (e.g., at a second location 224 which is indicative of the location 222). The imaging system can store the position and / or the orientation of the first circuit upon being triggered to do so.

[0049] For another example, the at least one tissue marker 230 comprises the distal end portion 212 of the member 210, and the imaging system is configured to image the distal end portion 212 and the portion of tissue surrounding the distal end portion 212 within the recipient. The imaging system can store the position and / or the orientation of the distal end portion 212 upon being triggered to do so.

[0050] During a subsequent, separate procedure (e.g., after the pre-operative test procedure during which the apparatus 200 is used), the implant 100 can be surgically implanted (e.g., by an entity, who can be the entity that performed the pre-operative test using the apparatus 200 or a different entity). FIG. 2C schematically illustrates an example implant 100 comprising a stimulation element 148 (e.g., electrode) affixed to the location 222 in accordance with certain implementations described herein. For example, the surgical implantation of the implant 100 can comprise drilling a recess in the cochlear promontory 123 and affixing the stimulation element 148 at the recess. In certain implementations, by using the indication 232 (e.g., the entity performing the implantation visually identifying the position and / or orientation of the indication 232), the recess and the stimulation element 148 of the implant 100 are placed by the entity during the surgical procedure at the same location 222 at which the electrical signals applied by the distal end portion 212 of the apparatus 200 had the greatest efficacious effect in treating the malady during the pre-operative test and / or had the least amount of undesirable effects. In certain implementations, use of the indication 232 can reduce (e.g., prevent; avoid) inconsistent clinical results for recipients using the implant 100 as compared to the results of the pre-operative testing using the apparatus 200 (e.g., ensuring clinical benefits using the implant 100 that are consistent with those identified during the pre-operative testing using the apparatus 200).

[0051] FIGs. 4A and 4B are flow diagrams of two example methods 400, 450 in accordance with certain implementations described herein. While the example methods 400,450 of FIGs. 4A-4B are described by reference to the example apparatus 200 of FIGs. 2A-2C, the example methods 400,450 of FIGs. 4A-4B can be performed by other structures inaccordance with certain implementations described herein. In certain implementations, only one of the example methods 400,450 is used, while in certain other implementations, both of the example methods 400,450 are used in combination with one another.

[0052] In an operational block 410, the method 400 comprises inserting a stimulator (e.g., apparatus 200 comprising at least one electrode 220 on the distal end portion 212) into a recipient. For example, a transtympanic needle of the apparatus 200 can be inserted through the tympanic membrane 104 such that a distal end portion 212 of the needle contacts the cochlear promontory 123.

[0053] In an operational block, 420, the method 400 further comprises using the stimulator to stimulate tissue at a location within the recipient. For example, the stimulator can be used to apply stimulation signals to a portion of the cochlear promontory 123 at the location 222.

[0054] In an operational block 430, the method 400 further comprises generating an indication of the location. For example, the indication can be generated by selectively triggering the at least one target marker 230 to generate the indication 232. The indication can be selected from the group consisting of: an ablated tissue portion; a thermally damaged tissue portion; a mechanically deformed tissue portion; a marked tissue portion; a detached portion of the stimulator (e.g., tag; fiducial) affixed to the tissue portion; a computer-generated virtual indication. In certain implementations, the stimulator is not moved between said using the stimulator and said generating the indication.

[0055] In an operational block 440, the method 400 further comprises removing the stimulator from the recipient. The indication is accessible (e.g., visible) during a surgical procedure performed after said removing the stimulator from the recipient.

[0056] In an operational block 460, the method 450 comprises detecting a previously-generated indication of a location within a recipient. For example, a previously-generated indication 232 (e.g., an indication generated in the operational block 430) can be detected (e.g., visually observed) by an entity (e.g., clinician; surgeon; robotic surgical system) during an implantation procedure for implanting the implant 100 (e.g., with a stimulation element 148 placed at the location 222 on the cochlear promontory 123).

[0057] In an operational block 470, the method 450 further comprises surgically implanting at least one electrode (e.g., stimulation element 148 of the implant 100) at the location (e.g., the location 222).

[0058] It is to be appreciated that the implementations disclosed herein are not mutually exclusive and may be combined with one another in various arrangements. In addition, although the disclosed methods and apparatuses have largely been described in the context of various devices, various implementations described herein can be incorporated in a variety of other suitable devices, methods, and contexts. More generally, as can be appreciated, certain implementations described herein can be used in a variety of implantable device contexts that can benefit from certain attributes described herein.

[0059] Language of degree, as used herein, such as the terms “approximately,” “about,” “generally,” and “substantially,” represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may refer to an amount that is within ± 10% of, within ± 5% of, within ± 2% of, within ± 1 % of, or within ± 0.1% of the stated amount. As another example, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by ± 10 degrees, by ± 5 degrees, by ± 2 degrees, by ± 1 degree, or by ± 0.1 degree, and the terms “generally perpendicular” and “substantially perpendicular” refer to a value, amount, or characteristic that departs from exactly perpendicular by ± 10 degrees, by ± 5 degrees, by ± 2 degrees, by ± 1 degree, or by ± 0.1 degree. The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” less than,” “between,” and the like includes the number recited. As used herein, the meaning of “a,” “an,” and “said” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “into” and “on,” unless the context clearly dictates otherwise.

[0060] While the methods and systems are discussed herein in terms of elements labeled by ordinal adjectives (e.g., first, second, etc.), the ordinal adjective are used merely as labels to distinguish one element from another (e.g., one signal from another or one circuitfrom one another), and the ordinal adjective is not used to denote an order of these elements or of their use.

[0061] The invention described and claimed herein is not to be limited in scope by the specific example implementations herein disclosed, since these implementations are intended as illustrations, and not limitations, of several aspects of the invention. Any equivalent implementations are intended to be within the scope of this invention. Indeed, various modifications of the invention in form and detail, in addition to those shown and described herein, will become apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the claims. The breadth and scope of the invention should not be limited by any of the example implementations disclosed herein but should be defined only in accordance with the claims and their equivalents.

Claims

WHAT IS CLAIMED IS:

1. An apparatus comprising:an elongate member having a distal end portion configured to be inserted into a recipient;at least one electrode on the distal end portion, the at least one electrode configured to apply an electrical signal to tissue at a location within the recipient; and at least one tissue marker on the distal end portion, the at least one tissue marker configured to generate an indication of the location, the indication configured to be accessed by an entity performing a subsequent surgical procedure during the subsequent surgical procedure.

2. The apparatus of claim 1, wherein the member comprises a needle.

3. The apparatus of claim 2, wherein the needle is a transtympanic needle and the tissue comprises a portion of a cochlear promontory.

4. The apparatus of any preceding claim, wherein the at least one electrode comprises an electrically conductive portion of the distal end portion.

5. The apparatus of any preceding claim, wherein the at least one tissue marker is configured to modify the tissue at the location and / or at a second location having a predetermined spacing and orientation relative to the location.

6. The apparatus of claim 5, wherein the at least one tissue marker comprises at least one light source configured to emit light configured to damage a portion of the tissue.

7. The apparatus of claim 6, wherein the at least one light source comprises at least one optical waveguide extending along the member and configured to receive the light from a laser, to transmit the light to the distal end portion, and to emit the light from the distal end portion.

8. The apparatus of claim 7, wherein the light is configured to damage a portion of tissue, the indication comprising the damaged tissue.

9. The apparatus of claim 5, wherein the at least one tissue marker comprises at least one resistive heater configured to thermally damage a portion of the tissue, the indication comprising the damaged tissue.

10. The apparatus of claim 5, wherein the at least one tissue marker comprises at least one dye source configured to deposit dye on a portion of the tissue.

11. The apparatus of claim 10, wherein the at least one tissue marker comprises at least one fluid conduit extending along the member and configured to receive the dye from a reservoir, to transmit the dye to the distal end portion, and to emit the dye from the distal end portion, the indication comprising dyed tissue.

12. The apparatus of claim 11, wherein the at least one fluid conduit comprises an orifice configured to deposit the dye onto the portion of the tissue.

13. The apparatus of claim 11, wherein the at least one fluid conduit comprises an end portion configured to be pressed against the portion of the tissue to deposit the dye onto the portion of tissue.

14. The apparatus of any of claims 10 to 13, wherein the dye is visibly distinct from surrounding tissue at least until the subsequent surgical procedure.

15. The apparatus of any of claims 10 to 14, wherein the dye comprises a contrast agent configured to be seen in pre-operative imaging.

16. The apparatus of claim 5, wherein the at least one tissue marker comprises at least one detachable portion of the member, the at least one detachable portion configured to controllably detach from the member and to adhere to a portion of the tissue.

17. The apparatus of claim 5, wherein the at least one tissue marker comprises at least one cutting tool configured to remove a portion of the tissue.

18. The apparatus of claim 17, wherein the at least one cutting tool is selected from the group consisting of: drill bit; end mill; abrasive substance.

19. The apparatus of claim 18, wherein the at least one tissue marker comprises a piezoelectric element and an abrasive surface configured to be placed in contact with the portion of tissue, the piezoelectric element configured to vibrate while the abrasive surface is in contact with the portion of the tissue.

20. An apparatus comprising:a needle configured to be inserted into a recipient; andat least one electrode at a distal end portion of the needle, the at least one electrode configured to apply a therapeutic stimulation to tissue at a location within the recipient, the distal end portion configured to be detected by an imaging system, the imaging system configured to detect a position and / or an orientation of the distal endportion and to generate a virtual indication of the location, the virtual indication configured to be accessed by an entity performing a subsequent surgical procedure during the subsequent surgical procedure.

21. The apparatus of claim 20, wherein the imaging system is configured to image a portion of tissue within the recipient utilizing x-rays and / or ultrasound.

22. The apparatus of claim 20 or claim 21, wherein the imaging system comprises a video or 3D scanning system.

23. The apparatus of any of claims 20 to 22, wherein the imaging system is configured to be triggered to generate and store the virtual indication of the location relative to at least one tissue landmark within the recipient.

24. The apparatus of any of claims 20 to 23, wherein the distal end portion comprises a first circuit and the imaging system comprises a second circuit configured to respond to the first circuit by recording a position and / or an orientation of the first circuit upon being triggered to do so.

25. The apparatus of claim 24, wherein the first circuit comprises a coil, an RF antenna, or an RFID tag.

26. The apparatus of claim 20, wherein the imaging system is configured to image the distal end portion and a portion of tissue surrounding the distal end portion within the recipient.

27. A method comprising:inserting a stimulator into a recipient;using the stimulator to stimulate tissue at a location within the recipient; generating an indication of the location; andremoving the stimulator from the recipient, wherein the indication is accessible during a surgical procedure performed after said removing the stimulator from the recipient.

28. The method of claim 27, wherein the stimulator comprises a test electrode and the tissue comprises a portion of a cochlear promontory.

29. The method of claim 27 or claim 28, wherein the indication is selected from the group consisting of: an ablated tissue portion; a thermally damaged tissue portion; amechanically deformed tissue portion; a marked tissue portion; a detached portion of the stimulator affixed to the tissue portion; a computer-generated virtual indication.

30. The method of any of claims 27 to 29, wherein the stimulator is not moved between said using the stimulator and said generating the indication.

31. A method comprising:detecting a previously-generated indication of a location within a recipient; and surgically implanting at least one electrode at the location.

32. The method of claim 31, wherein the location is on a cochlear promontory.

33. The method of claim 31 or claim 32, wherein the indication is selected from the group consisting of: an ablated tissue portion; a thermally damaged tissue portion; a mechanically deformed tissue portion; a marked tissue portion; a fiducial affixed to the tissue portion; a computer-generated virtual indication.

34. The method of any of claims 31 to 33, wherein said detecting comprises visually observing the previously-generated indication.

35. The method of any of claims 27 to 34 wherein the indication is used for implantation of a sleep disorder system, a seizure system, a balance or movement disorder system, a tinnitus management system, or sensory prosthesis system.

36. The apparatus of any of claims 1 to 26, wherein the subsequent surgical procedure comprises implantation of a component of a sleep disorder device, a seizure device, a balance or movement disorder device, a tinnitus management device, or a sensory prosthesis device.

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