Implantable apparatus with electrically insulated coupler

Abstract

An apparatus includes an electrically conductive housing configured to be implanted beneath a skin portion of a recipient's body. The apparatus further includes a transducer on or within the housing. The transducer is configured to receive and / or to generate vibrations. The apparatus further includes an electrically insulative and biocompatible material overlaying the housing. The material is configured to electrically insulate the housing and the transducer from the recipient's body. The apparatus further includes at least one vibration conduit configured to be in contact with the recipient's body and to transfer the vibrations between the recipient's body and the transducer. The at least one vibration conduit includes a first portion covered by the material and a second portion not covered by the material.

Description

COCLR.090WO PCT APPLICATIONIMPLANTABLE APPARATUS WITH ELECTRICALLY INSULATED COUPLERBACKGROUNDField

[0001] The present application relates generally to a device configured to be implanted within a recipient’s body.Description of the 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, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease / injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and / or data received from external devices that are part of, or operate in conjunction with, implantable components.SUMMARY

[0004] In one aspect disclosed herein, an apparatus comprises an electrically conductive housing configured to be implanted beneath a skin portion of a recipient’s body. The apparatus further comprises a transducer on or within the housing. The transducer is configured to receive and / or to generate vibrations. The apparatus further comprises an electrically insulative and biocompatible material overlaying the housing. The material isconfigured to electrically insulate the housing and the transducer from the recipient’s body. The apparatus further comprises at least one vibration conduit configured to be in contact with the recipient’s body and to transfer the vibrations between the recipient’s body and the transducer. The at least one vibration conduit comprises a first portion covered by the material and a second portion not covered by the material.

[0005] In another aspect disclosed herein, a method comprises providing an implant comprising an electrically conductive body. The implant further comprises a device on or within the body, the device comprising a vibration sensor or a vibration generator on or within the body. The implant further comprises an electrically insulative and biocompatible coating on the body, the coating configured to electrically isolate the body from tissue and / or fluid surrounding the body. The implant further comprises at least one elongate member, at least a portion of the at least one elongate member embedded within the coating, the at least one elongate member configured to transmit vibrations between the device and the tissue and / or fluid. The method further comprises affixing the body to a first portion of the tissue. The method further comprises affixing an end portion of the at least one elongate member to a second portion of the tissue.

[0006] In another aspect disclosed herein, a system comprises an electrically conductive body configured to be subcutaneously implanted within a recipient. The system further comprises a diaphragm on or within the body. The diaphragm is configured to receive vibrations from tissue of the recipient and / or to transmit vibrations to the tissue of the recipient. The system further comprises at least one elongate member comprising a first end portion in mechanical communication with the diaphragm and a second end portion configured to be affixed to the tissue. The system further comprises at least one electrically insulative layer substantially surrounding the body and the diaphragm and configured to electrically insulate the body and the diaphragm from the recipient. The system further comprises at least one propagation path of the vibrations between the diaphragm and the tissue. The at least one propagation path extends from the second end portion of the at least one elongate member to the diaphragm and extending through at least some of the at least one electrically insulative layer.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Implementations are described herein in conjunction with the accompanying drawings, in which:

[0008] FIG. 1 is a perspective view of an example cochlear implant auditory prosthesis implanted in a recipient in accordance with certain implementations described herein;

[0009] FIG. 2 is a perspective view of an example fully implantable middle ear implant auditory prosthesis implanted in a recipient in accordance with certain implementations described herein;

[0010] FIG. 3 schematically illustrate a portion of another example transcutaneous bone conduction auditory prosthesis implanted in a recipient in accordance with certain implementations described herein;

[0011] FIG. 4 schematically illustrates a side cross-sectional view of an example apparatus in accordance with certain implementations described herein;

[0012] FIGs. 5A-5B schematically illustrate, respectively, a side perspective view of a portion of another example apparatus and a side cross-sectional view of the example apparatus of FIG. 5 A in accordance with certain implementations described herein;

[0013] FIG. 6 schematically illustrates views along a center axis of the first end portion of various other examples of the first end portion and the plurality of recesses in accordance with certain implementations described herein; and

[0014] FIG. 7 is a flow diagram of an example method in accordance with certain implementations described herein.DETAILED DESCRIPTION

[0015] Certain implementations described herein provide an implantable device comprising a housing containing a vibration sensor and / or generator, a diaphragm on or within the housing, an electrically insulative coating over the housing and the diaphragm, and an elongate member in mechanical communication with the diaphragm and configured to receive and / or transmit vibrations between the diaphragm and a portion of the recipient’s tissue. The coating is configured to electrically isolate the housing and diaphragm from the recipient’s body to reduce or eliminate electrical currents between the housing and the recipient’s body that can adversely affect performance of the vibration sensor and / or generator. The electricallyinsulative coating constitutes a portion of the propagation path of vibrations between the diaphragm and the recipient’s tissue. The coating and the portion of the elongate member in mechanical communication with the coating can be configured to provide the electrical isolation while not adversely reducing the acoustic sensitivity of the vibration sensor and / or generator.

[0016] The teachings detailed herein are applicable, in at least some implementations, to any type of implantable stimulation and / or measurement system (e.g., implantable sensory prosthesis system; implantable auditory prosthesis system; hearing systems for hearing-impaired recipients and / or non-hearing- impaired recipients; neurostimulation system; machine-brain interface system; muscle stimulation system). The system can comprise a first portion implanted on or within the recipient’s body and a second portion (e.g., implanted on or within the recipient or external to the recipient’s body). For example, the first portion can be configured to provide stimulation signals to a portion of the recipient’s body in response to received information and / or control signals from the second portion of the system. For another example, the first portion can be configured to generate sensor signals indicative of an attribute of the portion of the recipient’s body and to provide the sensor signals to the second portion. For example, the second portion of the system can be worn on the recipient’s head, in the ear (ITE), behind the ear (BTE), or off the ear (OTE). For example, such hearing devices can include, but are not limited to: sound processing units for cochlear implant systems, middle ear actuator implant systems, or bone-anchored hearing aids; hearing aids; consumer wireless earbuds.

[0017] 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 auditory prosthesis devices, certain other implementations are compatible in the context of other types of devices or systems that provide a wide range of therapeutic benefits to recipients, patients, or other users (e.g., brain implants; devices for monitoring and / or treating epileptic events such as seizures, depression, and / or strokes).

[0018] Merely for ease of description, apparatus and methods disclosed herein are primarily described with reference to an illustrative medical system comprising an implantable auditory prosthesis device (e.g., implantable transducer assembly) configured to generate andapply stimulation signals (e.g., electrical and vibrational) that are perceived by the recipient as sounds (e.g., evoking a hearing percept), examples of which include but are 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,” “semiimplantable,” “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 auditory prosthesis devices, certain other implementations are compatible with of other types of sensory prosthesis systems that are configured to evoke other types of neural or sensory (e.g., 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); sensors; cardiac pacemakers; electrocardiogram monitoring of heart function; drug delivery systems; defibrillators; functional electrical stimulation devices; catheters; neurostimulators; somatosensory implants; chemosensory implants; sleep apnea devices; electroporation devices; pain relief devices; bladder control devices; swallowing treatment devices (e.g., device for treating difficulties with the hyoglossus and / or thyrohyoid muscles); dysphagia treatment devices; devices for treating dry mouth (e.g., xerostomia or hyposalivation), devices for treating excessive or absence of muscle movement due to stroke, Parkinson’s disease, or other brain disorders; devices for treating hypertension (e.g., by stimulating the carotid sinus barosensory system); etc.

[0020] FIG. 1 is a perspective view of an example cochlear implant auditory prosthesis 100 implanted in a recipient in accordance with certain implementations describedherein. The example auditory prosthesis 100 is shown in FIG. 1 as comprising an implanted stimulator unit 120 and a microphone assembly 124 that is external to the recipient (e.g., a partially implantable cochlear implant). An example auditory prosthesis 100 (e.g., a totally implantable cochlear implant; a mostly implantable cochlear implant) in accordance with certain implementations described herein can replace the external microphone assembly 124 shown in FIG. 1 with a subcutaneously implantable microphone assembly, as described more fully herein.

[0021] 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 or fenestra 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.

[0022] As shown in FIG. 1, the example auditory prosthesis 100 comprises one or more components which are temporarily or permanently implanted in the recipient. The example auditory prosthesis 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 sound processing 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 implementations of FIG. 1, the external transmitter unit 128 comprises an external coil 130 (e.g., a wire antenna coilcomprising 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 processes the output of the microphone 124 and 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 auditory prosthesis 100, where the auditory prosthesis 100 includes a battery or other power storage device (e.g., circuitry 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 auditory prosthesis 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 auditory prosthesis 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 electrode 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 hermetically sealed within a biocompatible housing, sometimes collectively referred to as astimulator / 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 elongate electrode assembly 118.

[0025] The elongate electrode assembly 118 has a proximal end connected to the stimulator unit 120, and a distal end implanted in the cochlea 140. The electrode assembly 118 extends from the stimulator unit 120 to the cochlea 140 through the mastoid bone 119. In some implementations, the electrode assembly 118 may be implanted at least in the basal region 116, and sometimes further. For example, the electrode assembly 118 may extend towards apical end of cochlea 140, referred to as cochlea apex 134. In certain circumstances, the electrode 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 elongate electrode assembly 118 comprises a longitudinally aligned and distally extending array 146 of electrodes or contacts 148, sometimes referred to as electrode or contact array 146 herein, disposed along a length thereof. Although the electrode array 146 can be disposed on the electrode assembly 118, in most practical applications, the electrode array 146 is integrated into the electrode assembly 118 (e.g., the electrode array 146 is disposed in the electrode assembly 118). As noted, the stimulator unit 120 generates stimulation signals which are applied by the electrodes 148 to the cochlea 140, thereby stimulating the auditory nerve 114.

[0027] While FIG. 1 schematically illustrates an auditory prosthesis 100 utilizing an external component 142 comprising an external microphone 124, an external sound processing unit 126, and an external power source, in certain other implementations, one or more of the microphone 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 auditory prosthesis 100 can have each of the microphone 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 (“HCI”). For another example, the auditory prosthesis 100 can have most components of the cochlear implant (e.g., excluding the microphone, which can be an in-the-ear-canalmicrophone) implantable on or within the recipient, and can be referred to as a mostly implantable cochlear implant (“MICI”).

[0028] FIG. 2 schematically illustrates a perspective view of an example fully implantable auditory prosthesis 200 (e.g., fully implantable middle ear implant or totally implantable acoustic system), implanted in a recipient, utilizing an acoustic actuator in accordance with certain implementations described herein. The example auditory prosthesis 200 of FIG. 2 comprises a biocompatible implantable assembly 202 (e.g., comprising an implantable capsule) located subcutaneously (e.g., beneath the recipient’s skin and on a recipient's skull). While FIG. 2 schematically illustrates an example implantable assembly 202 comprising a microphone, in other example auditory prostheses 200, a pendant microphone can be used (e.g., connected to the implantable assembly 202 by a cable). The implantable assembly 202 includes a signal receiver 204 (e.g., comprising a coil element) and an acoustic transducer (e.g., a microphone assembly 206 comprising a diaphragm and an electret or piezoelectric transducer) that is positioned to receive acoustic signals through the recipient’s overlying tissue. The implantable assembly 202 may further be utilized to house a number of components of the fully implantable auditory prosthesis 200. For example, the implantable assembly 202 can include a power storage device (e.g., battery or other power storage circuitry) and a signal processor (e.g., a sound processing unit). Various additional processing logic and / or circuitry components can also be included in the implantable assembly 202 as a matter of design choice.

[0029] For the example auditory prosthesis 200 shown in FIG. 2, the signal processor of the implantable assembly 202 is in operative communication (e.g., electrically interconnected via a wire 208) with an actuator 210 (e.g., comprising a transducer configured to generate mechanical vibrations in response to electrical signals from the signal processor). In other example auditory prostheses 200, the signal processor of the implantable assembly 202 is in wireless communication with the actuator 210. In certain implementations, the example auditory prosthesis 100, 200 shown in FIGs. 1 and 2 can comprise an implantable microphone assembly, such as the microphone assembly 206 shown in FIG. 2. For such an example auditory prosthesis 100, the signal processor of the implantable assembly 202 can be in operative communication (e.g., electrically interconnected via a wire) with the microphone assembly 206 and the stimulator unit 120 of the main implantable component. In certainimplementations, at least one of the microphone assembly 206 and the signal processor (e.g., a sound processing unit) is implanted on or within the recipient.

[0030] The actuator 210 of the example auditory prosthesis 200 shown in FIG. 2 is supportably connected to a positioning system 212, which in turn, is connected to a bone anchor 214 mounted within the recipient's mastoid process (e.g., via a hole drilled through the skull). The actuator 210 includes a connection apparatus 216 for connecting the actuator 210 to the ossicles 106 of the recipient. In a connected state, the connection apparatus 216 provides a communication path for acoustic stimulation of the ossicles 106 (e.g., through transmission of vibrations from the actuator 210 to the incus 109).

[0031] During normal operation, ambient acoustic signals (e.g., ambient sound) impinge on the recipient’s tissue and are received transcutaneously at the microphone assembly 206. Upon receipt of the transcutaneous signals, a signal processor within the implantable assembly 202 processes the signals to provide a processed audio drive signal (e.g., via wire 208 or via wireless communication) to the actuator 210. As will be appreciated, the signal processor may utilize digital processing techniques to provide frequency shaping, amplification, compression, and other signal conditioning, including conditioning based on recipient-specific fitting parameters. The audio drive signal causes the actuator 210 to transmit vibrations at acoustic frequencies to the connection apparatus 216 to affect the desired sound sensation via mechanical stimulation of the incus 109 of the recipient.

[0032] The subcutaneously implantable microphone assembly 202 is configured to respond to auditory signals (e.g., sound; pressure variations in an audible frequency range) by generating output signals (e.g., electrical signals; optical signals; electromagnetic signals) indicative of the auditory signals received by the microphone assembly 202, and these output signals are used by the auditory prosthesis 100, 200 to generate stimulation signals which are provided to the recipient’s auditory system. To compensate for the decreased acoustic signal strength reaching the microphone assembly 202 by virtue of being implanted, the diaphragm of an implantable microphone assembly 202 can be configured to provide higher sensitivity than are external non-implantable microphone assemblies. For example, the diaphragm of an implantable microphone assembly 202 can be configured to be more robust and / or larger than diaphragms for external non-implantable microphone assemblies.

[0033] FIG. 3 schematically illustrate a portion of an example transcutaneous bone conduction auditory prosthesis 300 implanted in a recipient in accordance with certain implementations described herein. As schematically illustrated by FIG. 3, the example transcutaneous bone conduction auditory prosthesis 300 comprises an external device component and an implantable component 306. The auditory prosthesis 300 is an active transcutaneous bone conduction auditory prosthesis in that the vibrating actuator 308 is located in the implantable component 306. For example, a vibratory element in the form of a vibrating actuator 308 is located in a housing 310 of the implantable component 306. In certain implementations, the vibrating actuator 308 is a device that converts electrical signals into vibration. The vibrating actuator 308 can be in direct contact with the outer surface of the recipient’s bone 196 (e.g., the vibrating actuator 308 is in substantial contact with the recipient’s bone 196 such that vibration forces from the vibrating actuator 308 are communicated from the vibrating actuator 308 to the recipient’s bone 196). In certain implementations, there can be one or more thin non-bone tissue layers (e.g., a silicone layer 324) between the vibrating actuator 308 and the recipient’s bone 196 (e.g., bone tissue; skull bone) while still permitting sufficient support so as to allow efficient communication of the vibration forces generated by the vibrating actuator 308 to the recipient’s bone 196.

[0034] In certain implementations, the external component 304 includes a sound input element 326 that converts sound into electrical signals. Specifically, the auditory prosthesis 300 provides these electrical signals to the vibrating actuator 308, or to a sound processor (not shown) that processes the electrical signals, and then provides those processed signals to the implantable component 306 through the tissue of the recipient (e.g., skin 190, fat 192, muscle 194) via a magnetic inductance link. For example, a communication coil 332 of the external component 304 can transmit these signals to an implanted communication coil 334 located in a housing 336 of the implantable component 306. Components (not shown) in the housing 336, such as, for example, a signal generator or an implanted sound processor, then generate electrical signals to be delivered to the vibrating actuator 308 via electrical lead assembly 338. The vibrating actuator 308 converts the electrical signals into vibrations. In certain implementations, the vibrating actuator 308 can be positioned with such proximity to the housing 336 that the electrical leads 338 are not present (e.g., the housing 310 and the housing 336 are the same single housing containing the vibrating actuator 308, thecommunication coil 334, and other components, such as, for example, a signal generator or a sound processor).

[0035] In certain implementations, the vibrating actuator 308 is mechanically coupled to the housing 310. The housing 310 and the vibrating actuator 308 collectively form a vibrating element. The housing 310 can be substantially rigidly attached to a bone fixture 318.

[0036] In this regard, the housing 310 can include a through hole 320 that is contoured to the outer contours of the bone fixture 318. The screw 322 can be used to secure the housing 310 to the bone fixture 318. As can be seen in FIG. 3, the head of the screw 322 is larger than the through hole 320 of the housing 310, and thus the screw 322 positively retains the housing 310 to the bone fixture 318. A portion of the screw 322 interfaces with the bone fixture 318, thus permitting the screw 322 to readily fit into an existing bone fixture 318 used in a percutaneous bone conduction device (or an existing passive bone conduction device). In certain implementations, the screw 322 is configured so that the same tools and procedures that are used to install and / or remove an abutment screw from the bone fixture 318 can be used to install and / or remove the screw 322 from the bone fixture 318.

[0037] The bone fixture 318 can be made of any material that has a known ability to integrate into surrounding bone tissue (e.g., comprising a material that exhibits acceptable osseointegration characteristics). In certain implementations, the bone fixture 318 is formed from a single piece of material (e.g., titanium) and comprises outer screw threads forming a male screw which is configured to be installed into the skull bone 196 and a flange configured to function as a stop when the fixture 318 is implanted into the skull bone 196. The screw threads can have a maximum diameter of about 3.5 mm to about 5.0 mm, and the flange can have a diameter which exceeds the maximum diameter of the screw threads (e.g., by approximately 10%-20%). The flange can have a planar bottom surface for resting against the outer bone surface, when the fixture 318 has been screwed down into the skull bone 196. The flange prevents the fixture 318 (e.g., the screw threads) from potentially completely penetrating completely through the bone 196.

[0038] The body of the fixture 318 can have a length sufficient to securely anchor the fixture 318 to the skull bone 196 without penetrating entirely through the skull bone 196. The length of the body can therefore depend on the thickness of the skull bone 196 at theimplantation site. For example, the fixture 318 can have a length, measured from the planar bottom surface of the flange to the end of the distal region (e.g., the portion farthest from the flange), that is no greater than 5 mm or between about 3.0 mm to about 5.0 mm, which limits and / or prevents the possibility that the fixture 318 might go completely through the skull bone 196. The interior of the fixture 318 can further include an inner lower bore having female screw threads configured to mate with male screw threads of the screw 322 to the fixture 318. The fixture 318 can further include an inner upper bore that receives a bottom portion of the abutment 312.

[0039] The example auditory prostheses 100 shown in FIG. 1 utilizes an external microphone 124, the auditory prosthesis 200 shown in FIG. 2 utilizes an implantable microphone assembly 206 comprising a subcutaneously implantable acoustic transducer, and the example transcutaneous bone conduction auditory prosthesis 300 of FIG. 3 comprises an external sound input element 326 (e.g., external microphone). In certain implementations described herein, a subcutaneously implantable sound input assembly (e.g., implanted microphone) is used with the auditory prostheses 100, 200, 300 and / or one or more external microphone assemblies is used with the auditory prostheses 100, 200, 300. In certain implementations, an external microphone assembly can be used to supplement an implantable microphone assembly of the auditory prosthesis 100, 200, 300. Thus, the teachings detailed herein and / or variations thereof can be utilized with any type of external or implantable microphone arrangement, and the acoustic prostheses 100, 200, 300 shown in FIGs. 1, 2, and 3 are merely illustrative.

[0040] FIGs. 4 and 5A-5B schematically illustrate examples of an apparatus 400 in accordance with certain implementations described herein. The apparatus 400 comprises an electrically conductive housing 410 configured to be implanted beneath a skin portion (e.g., beneath at least one layer of skin 190, fat 192, and / or muscle 194) of a portion of a recipient’s body. The apparatus 400 further comprises a transducer 420 on or within the housing 410, the transducer 420 configured to receive and / or to generate vibrations. The apparatus 400 further comprises an electrically insulative and biocompatible material 430 overlaying the housing 410. The material 430 is configured to electrically insulate the housing 410 and the transducer 420 from the recipient’s body. The apparatus 400 further comprises at least one vibration conduit 440 configured to be in contact with the recipient’s body and to transfer the vibrationsbetween the recipient’s body and the transducer 420. The at least one vibration conduit 440 comprises a first portion 442 covered by the material 430 and an elongate second portion 444 not covered by the material 430. In certain implementations, at least some of the material 430 constitutes a portion of the propagation path of vibrations between the transducer 420 and the at least one vibration conduit 440. FIG. 4 schematically illustrates a side cross-sectional view of an example apparatus 400 in accordance with certain implementations described herein, and FIGs. 5A-5B schematically illustrate, respectively, a side perspective view of a portion of another example apparatus 400 and a side cross-sectional view of the example apparatus 400 of FIG. 5 A in accordance with certain implementations described herein.

[0041] In certain implementations, the apparatus 400 is a component of a stimulation system configured to provide stimulation signals to the recipient, while in certain other implementations, the apparatus 400 is a component of a measurement system configured to generate measurement signals indicative of a characteristic of the recipient’s body. For a sensory stimulation system (e.g., auditory prosthesis system; visual prosthesis system), the stimulation signals can be configured to be received and perceived by the recipient as sensory information. For example, the apparatus 400 can comprise an implanted stimulator unit 120 of a cochlear implant auditory prosthesis 100, an actuator 210 of a middle ear implant 200, or an implantable component 306 of a transcutaneous bone conduction auditory prosthesis 300.

[0042] In certain implementations, the housing 410 (e.g., body) comprises a biocompatible material (e.g., metal; titanium; titanium alloy; stainless steel) configured to be positioned subcutaneously (e.g., beneath at least one layer of skin 190, fat 192, and / or muscle 194) and above and / or within a bone portion (e.g., skull bone 196) of the recipient’s body. The housing 410 can have a width (e.g., along a lateral direction substantially parallel to the surface of the bone portion) less than or equal to 60 millimeters (e.g., in a range of 15 millimeters to 50 millimeters; in a range of 20 millimeters to 40 millimeters; in a range of less than 30 millimeters; in a range of 15 millimeters to 30 millimeters). The housing 410 can have a thickness (e.g., in a direction substantially perpendicular to the surface of the bone portion) less than or equal to 10 millimeters (e.g., in a range of less than or equal to 7 millimeters, in a range of less than or equal to 6 millimeters; in a range of less than or equal to 5 millimeters).

[0043] In certain implementations in which the apparatus 400 is configured to be in wireless communication with a non-implanted device externally worn by the recipient (e.g.,to wirelessly receive control signals from the device and / or to wirelessly transmit measurement signals to the device), at least one portion of the housing 410 can further comprise at least one material (e.g., polymer; silicone; plastics; rubber; ceramics) that is substantially transparent to electromagnetic signals communicated between the apparatus 400 and the non-implanted device such that the housing 410 does not substantially interfere with the transmission of the electromagnetic signals between the apparatus 400 and the device.

[0044] In certain implementations, the housing 410 comprises an inner region 414 hermetically sealed from an environment surrounding the housing 410 (e.g., from tissue and / or fluid of the recipient’s body). The inner region 414 can contain at least a portion of the transducer 420. As schematically shown in FIG. 4, the transducer 420 can comprise a diaphragm 422 (e.g., integrated with the housing 410 or a separate component from the housing 410) beneath the material 430. The diaphragm 422 can be substantially planar with a thickness in a range of 10 microns to 40 microns (e.g., 20 microns to 30 microns) and a width in a range of less than 8 millimeters (e.g., 1 millimeter to 5 millimeters). The diaphragm 422 can be relatively fragile, particularly to radial forces experienced during manufacturing, testing, and / or surgery, and by spacing at least a portion of the at least one vibration conduit 440 from the diaphragm 422, certain implementations can reduce the probability of damage to the diaphragm 422 by such radial forces (e.g., the material 430 acting as a cushion and preventing hermeticity breaches of the apparatus 400).

[0045] In certain implementations, the transducer 420 comprises a microphone configured to receive sound vibrations from the at least one vibration conduit 440 and to generate signals in response to the sound vibrations received from the recipient’s body, the signals indicative of the sound vibrations (e.g., the signals to be used by stimulation circuitry to provide a hearing percept to the recipient). The microphone can comprise the diaphragm 422 and circuitry 424 (e.g., an electret or piezoelectric device) within the inner region 414 and in operable communication with the diaphragm 422. The diaphragm 422 can be configured to receive vibrations from the recipient’s body and the circuitry 424 can be configured to receive the vibrations from the diaphragm 422 and to generate measurement signals in response to (e.g., indicative of) the received vibrations. Other types of microphones (e.g., magnetic; dynamic; optical; electromechanical) are also compatible with certain implementations described herein.

[0046] In certain implementations, the transducer 420 comprises an actuator configured to generate vibrations in response to control signals (e.g., received wirelessly from an externally worn device and / or from an externally worn microphone) and to provide the vibrations to a portion of the recipient’s body (e.g., portion of the middle or inner ear) via the at least one vibration conduit 440. The actuator can comprise a diaphragm 422 configured to transmit vibrations to the recipient’s body and circuitry 424 (e.g., within the inner region 414) configured to drive the diaphragm 422 in response to the received control signals.

[0047] In certain implementations, the inner region 414 can also contain other circuitry and / or components of the apparatus 400, examples of which include but are not limited to: stimulation circuitry configured to provide stimulation signals to a portion of the recipient’s body in response to received information and / or control signals;. a power source (e.g., battery; capacitor) configured to store power wirelessly received from an external power source and to provide at least some of the power to other components of the apparatus 400; an antenna (e.g., RF antenna) configured to be in wireless communication with corresponding circuitry of a device external to the recipient’s body; control circuitry comprising at least one microcontroller (e.g., at least one application-specific integrated circuit (ASIC) microcontroller; digital signal processing (DSP) microcontroller; generalized integrated circuits programmed by software with computer executable instructions; microcontroller core) configured to receive data signals from the microphone and to generate output data signals and / or control signals to be transmitted to other components of the apparatus 400; storage circuitry comprising at least one tangible (e.g., non-transitory) computer readable storage medium (e.g., read only memory (ROM); random access memory (RAM); magnetic disk storage media; optical storage media; flash memory) configured to store information (e.g., data; commands) and / or encoded with computer executable software (e.g., a computer program downloaded as an application; executable data access logic, evaluation logic, and / or information outputting logic) comprising instructions for instructing the control circuitry during operation of the apparatus 400; other digital circuitry (e.g., registers; filters; output controllers; memory controllers).

[0048] In certain implementations, the housing 410 is configured to be affixed to a bone portion of the recipient’s body by at least one fixation element. For example, the at least one fixation element can extend through at least one orifice (not shown) of the housing 410and can be affixed to a bone portion underlying the apparatus 400. In certain implementations, the at least one fixation element comprises a bone fixture 318 and a screw 322 (see, e.g., FIG. 3). In certain other implementations, the at least one fixation element comprises at least one bone screw. For example, the at least one bone screw can comprise a material that exhibits acceptable osseointegration characteristics (e.g., titanium) and can comprise outer screw threads forming a male screw which is configured to be installed into the bone portion (e.g., skull bone 196) and a screw head that is wider than the at least one orifice of the housing 410. The at least one bone screw can be configured to positively retain the apparatus 400 to the bone portion.

[0049] In certain implementations, the electrically insulative and biocompatible material 430 (e.g., silicone; plastic; parylene; polymethine; PEEK; Teflon; ceramic; combinations thereof) comprises at least one layer (e.g., a single layer; multiple layers). In certain implementations, the material 430 comprises multiple layer portions (e.g., comprising the same material as one another or comprising different materials from one another) which are overmolded onto the housing 410 and onto other portions of the material 430 and / or the at least one vibration conduit 440 (e.g., formed by a two-stage overmolding process in which one layer is overmolded onto the housing 410 and a second layer is overmolded onto the first layer and a portion of the at least one vibration conduit 440). The material 430 can have a thickness in a range of 0.2 millimeter to 1 millimeter (e.g., in a range of 0.3 millimeter to 0.6 millimeter) over surfaces of the housing 410. The material 430 can extend over substantially the whole housing 410, including over the transducer 420 (e.g., microphone) at or on an outer wall of the housing 410 (e.g., over the diaphragm 422, as shown in FIG. 4). In certain implementations in which performance of the transducer 420 (e.g., microphone) within the housing 410 is adversely affected by electrical currents flowing between the housing 410 and the tissue and / or fluid of the recipient’s body (e.g., leakage from the signal, ground, and / or power wire leads; causing electrical interference and / or noise in the microphone acoustic signal; causing unbalance in the stimulation signals or unwanted sound percepts), the material 430 is configured to electrical isolate the housing 410 from the tissue and / or fluid of the recipient’s body, thereby reducing (e.g., minimizing; preventing) such electrical currents and their adverse effects.

[0050] In certain implementations (e.g., as shown in FIG. 4), the first portion 442 of the at least one vibration conduit 440 is in contact with and extending from the diaphragm 422, the material 430 overlaying the first portion 442, and the second portion 444 is electrically insulated from the first portion 442 by the material 430. The second portion 444 can be configured to transfer the vibrations between the recipient’s body (e.g., incus 109) and the first portion 442 via the material 430. In certain implementations, the first portion 442 and the second portion 444 are substantially colinear with one another (e.g., as shown in FIG. 4), while in certain other implementations, the first portion 442 and the second portion 444 are non- colinear with one another (e.g., laterally offset from one another but substantially parallel to one another; at a non-zero angle relative to one another). In certain implementations, each of the first portion 442 and the second portion 444is substantially straight (e.g., as shown in FIG. 4), while in certain other implementations, at least one of the first and second portions 442, 444 is curved or bent. Each of the first and second portions 442, 444 can have a width (e.g., in a direction substantially parallel to the diaphragm 422) in a range of 0.1 millimeter to 0.5 millimeter (e.g., 0.15 millimeter to 0.3 millimeter), the first portion 442 can have a length (e.g., in a direction substantially perpendicular to the diaphragm 422) in a range of 0.5 millimeter to 2 millimeters, and the second portion 444 can have a length (e.g., in the direction substantially perpendicular to the diaphragm 422) in a range of 3 millimeters to 10 millimeters (e.g., 4 millimeters to 8 millimeters).

[0051] As shown in FIG. 4, the first portion 442 can comprise a first elongate rod, tube, or wire affixed to the diaphragm 422 and extending substantially perpendicularly from the diaphragm 422. For example, the first portion 442 can have a first end portion affixed to the diaphragm 422 and a second end portion (e.g., ball tip) spaced from the diaphragm 422, the first portion 442 completely covered by the material 430. The second portion 444 can comprise a second elongate rod, tube, or wire having a first end portion 446 comprising a recess 447 (e.g., cup) configured to fit over the first portion 442 and the material 430 overlaying the first portion 442 and a second end portion 448 configured to be in contact with (e.g., affixed to) a portion of the recipient’s body (e.g., a ball tip adhered to the incus 109 by bone cement).

[0052] In certain implementations, at least one of the first portion 442 and the second portion 444 comprises an electrically conductive material (e.g., metal; titanium; titanium alloy; stainless steel; gold; platinum; CoCr alloy; MP35N alloy). For example, thesecond portion 444 of the at least one vibration conduit 440 can be electrically conductive and not electrically insulated from the recipient’s body, and the second portion 444 can be electrically insulated from the first portion 442 by the material 430. In certain other implementations, at least one of the first portion 442 and the second portion 444 can comprise an electrically insulative material (e.g., plastic; parylene; PEEK; Teflon; rubber; ceramic). The material 430 overlaying the first portion 442 can have a width (e.g., in a direction substantially parallel to the diaphragm 422) in a range of 10% to 50% (e.g., 20% to 40%) of the width of the diaphragm 422, and the portion of the material 430 between the second end portion of the first portion 442 and the inner wall of the first end portion 446 of the second portion 444 can be in a range of 100 microns to 1 millimeter (e.g., 300 microns to 600 microns).

[0053] The material 430 can form an electrically insulating enclosure (e.g., bag) around the first portion 442 and the housing 410, such that the first portion 442 and the housing 410 are electrically insulated from the recipient’s body and the at least one vibration conduit 440 can transmit vibrations between the transducer 420 and the recipient’ s body. At least some of the material 430 can constitute a portion of the propagation path of vibrations extending between the transducer 420 and the at least one vibration conduit 440 (e.g., extending from the second end portion 448 of the second portion 444, through the second portion 444, to the first end portion 446 of the second portion 444, through the material 430 between the second portion 444 and the first portion 442, and through the first portion 442 to the diaphragm 422). In certain implementations, at least a portion of the material 430 between the diaphragm 422 and the second end portion 448 of the second portion 444 is sufficiently resilient to prevent hermeticity breaches through the material 430 induced by radial forces applied to the second end portion 444 (e.g., during the implantation process).

[0054] In certain implementations (e.g., as shown in FIGs. 5A-5B), the at least one vibration conduit 440 comprises an elongate member 450, the first portion 442 comprises a first end portion 452 of the elongate member 450 and is embedded within the material 430, and the second portion 444 comprises a second end portion 454 of the elongate member 450, the second end portion 454 configured to be in contact with a portion of the recipient’s body (e.g., incus 109). The first end portion 452 can be spaced from the diaphragm 422 with a region 460 between the first end portion 452 and the diaphragm 422 containing the material 430.

[0055] In certain implementations, the elongate member 450 comprises a rod, tube, or wire affixed to and extending from the first end portion 452 (e.g., at a center of the first end portion 452). The rod, tube, or wire can extend substantially perpendicularly from the first end portion 452 or at a non-zero angle relative to a center axis of the first end portion 452. In certain implementations, the elongate member 450 (e.g., including the first end portion 452 and / or the second end portion 454) comprises an electrically conductive and biocompatible (e.g., metal; titanium; titanium alloy; stainless steel; gold; platinum; CoCr alloy; MP35N alloy), while in certain other implementations, the elongate member 450 (e.g., including the first end portion 452 and / or the second end portion 454) comprises an electrically insulative and biocompatible material (e.g., plastic; parylene; PEEK; Teflon; rubber; ceramic). In certain implementations, the rod, tube, or wire is substantially straight (e.g., FIGs. 5A-5B), while in certain other implementations, the rod, tube, or wire is curved or bent. The rod, tube, or wire can have a width (e.g., in a direction substantially perpendicular to a long axis of the elongate member 450) in a range of 0.1 millimeter to 0.5 millimeter (e.g., 0.15 millimeter to 0.3 millimeter) and a length (e.g., in a direction substantially along the long axis of the elongate member 450) in a range of 3 millimeters to 10 millimeters (e.g., 4 millimeters to 8 millimeters). In certain implementations, the second end portion 454 is configured to be in contact with a portion of the recipient’s body (e.g., a ball tip adhered to the incus 109 by bone cement).

[0056] In certain implementations (see, e.g., FIGs. 5A-5B), the first end portion 452 of the elongate member 450 comprises a substantially planar plate (e.g., disk) and a plurality of recesses 456 (e.g., orifices) configured to contain the material 430. In certain implementations, the plate is substantially planar and is substantially circular (see, e.g., FIG. 5 A), while in certain other implementations, the plate is nonplanar (e.g., curved) and / or has a non-circular shape (e.g., oval; square; rectangular; polygonal; irregular). The width of the first end portion 452 (e.g., in a direction substantially parallel to the diaphragm 422) can be in a range of 10% to 100% (e.g., 30% to 60%) of the width of the diaphragm 422. In certain implementations, one or more of the recesses 456 extends completely through the plate, while in certain other implementations, one or more of the recesses 456 extends only partly through the plate. In certain implementations, at least some of the recesses 456 are substantially circular (see, e.g., FIG. 5A), while in certain other implementations, at least some of therecesses 456 have a non-circular shape (e.g., oval; square; rectangular; polygonal; irregular). In certain implementations, the plurality of recesses 456 are distributed substantially symmetrically about a center axis of the plate (see, e.g., FIGs. 5A-5B), while in certain other implementations, the plurality of recesses 456 are distributed asymmetrically about the center axis of the plate.

[0057] FIG. 6 schematically illustrates views along a center axis of the first end portion 452 of various other examples of the first end portion 452 and the plurality of recesses 456 in accordance with certain implementations described herein. As shown in FIG. 6, the first end portion 452 and / or the recesses 456 can have various shapes, the recesses 456 can have various distributions relative to the center axis of the first end portion 452, and the first end portion 452 can include on or more protrusions 457 extending away from the center axis and / or displaced and extending substantially parallel to the center axis. The recesses 456 and / or protrusions 457 of the first end portion 452 are configured to be anchors which facilitate a mechanical connection between the first end portion 452 and the material 430. For example, the recesses 456 can be configured to contain (e.g., to be filled by) the material 430 and / or the protrusions 457 can be configured to be substantially surrounded by the material 430 (e.g., to provide anchoring features for the material 430 to adhere to, the anchoring features facilitating resilience of the apparatus 400 to radial forces applied during manufacturing, testing, and / or surgery). The geometries and sizes of the first end portion 452 and / or the recesses 456, in conjunction with the material 430 and the thickness of the region 460 can be configured to provide a predetermined stiffness of the at least one vibration conduit 440 (e.g., to produce an optimized or maximized sensitivity of the transducer 420). Certain other implementations comprise other forms of anchors, while certain other implementations do not comprise any anchors (e.g., no recesses; no protrusions).

[0058] In certain implementations, the region 460 between the diaphragm 422 and the first end portion 452 contains (e.g., is filled by) the material 430. The region 460 can have a thickness (e.g., in a direction substantially perpendicular to the diaphragm 422 and / or the first end portion 452) in a range of 10 microns to 1 millimeter (e.g., 100 microns to 300 microns). The material 430 can electrically isolate the first end portion 452 from the housing 410, transducer 420, and diaphragm 422, such that the housing 410, transducer 420, and diaphragm 422 are electrically insulated from the recipient’s body and the at least one vibrationconduit 440 can transmit vibrations between the transducer 420 and the recipient’s body via the material 430 within the region 460. For example, the elongate member 450 can be electrically conductive, and can be electrically insulated from the housing 410, transducer 420, and diaphragm 422 while not electrically insulated from the recipient’s body.

[0059] In certain implementations (see, e.g., FIG. 5B), the material 430 overlays at least a portion of the elongate member 450 between the first end portion 452 and the second end portion 454. While FIG. 5B shows the material 430 between the first and second end portions 452, 454 having a substantially conical shape, other shapes (e.g., cylindrical) are also compatible with certain implementations described herein.

[0060] The material 430 can form an electrically insulating enclosure (e.g., bag) around the first end portion 452 and the housing 410, and the elongate member 450 can transmit vibrations between the transducer 420 and the recipient’s body. At least some of the material 430 can constitute a portion of the propagation path of vibrations extending between the transducer 420 and the elongate member 450 (e.g., extending from the second end portion 454 of the elongate member 450, through the elongate member 450, to the first end portion 452 of the elongate member 450, through the material 430 in the region 460 between the elongate member 450 and the diaphragm 422, to the diaphragm 422). In certain implementations, at least a portion of the material 430 between the diaphragm 422 and the first end portion 452 of the elongate member 450 is sufficiently resilient to prevent hermeticity breaches through the material 430 induced by radial forces applied to the second end portion 454 of the elongate member 450 (e.g., during the implantation process).

[0061] FIG. 7 is a flow diagram of an example method 700 in accordance with certain implementations described herein. While the method 700 is described by referring to some of the structures of the example apparatus 400 described herein, other apparatus and systems with other configurations of components can also be used to perform the method 700 in accordance with certain implementations described herein.

[0062] In an operational block 710, the method 700 comprises providing an implant (e.g., apparatus 400) comprising an electrically conductive body (e.g., housing 410), a device (e.g., transducer 420) on or within the body, the device comprising a vibration sensor and / or a vibration generator on or within the body, an electrically insulative and biocompatible coating (e.g., material 430) on the body, the coating configured to electrically isolate the body fromtissue and / or fluid surrounding the body, and at least one elongate member (e.g., at least one vibration conduit 440; elongate member 450), at least a portion of the at least one elongate member embedded within the coating, the at least one elongate member configured to transmit vibrations between the device and the tissue and / or fluid.

[0063] In an operational block 720, the method 700 further comprises affixing the body to a first portion of the tissue. For example, during a surgical procedure, the implant can be placed on and affixed to a surface of a bone portion of the recipient’s body.

[0064] In an operational block 730, the method 700 further comprises affixing an end portion of the at least one elongate member to a second portion of the tissue. For example, during the surgical procedure, the second end portion 448 of FIG. 4 or the second end portion 454 of FIG. 5B can be affixed to the tissue (e.g., incus 109).

[0065] In certain implementations, affixing the body to the first portion of the tissue is performed prior to affixing the end portion to the second portion of the tissue, while in certain other implementations, affixing the body to the first portion of the tissue is performed after affixing the end portion to the second portion of the tissue.

[0066] In certain implementations, the method 700 further comprises transmitting vibrations between the device and the second portion of the tissue via the at least one elongate element and the coating.

[0067] Although commonly used terms are used to describe the systems and methods of certain implementations for ease of understanding, these terms are used herein to have their broadest reasonable interpretations. Although various aspects of the disclosure are described with regard to illustrative examples and implementations, the disclosed examples and implementations should not be construed as limiting. Conditional language, such as, among others, "can," "could," "might," or "may," unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain implementations include, while other implementations do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that features, elements and / or steps are in any way required for one or more implementations or that one or more implementations necessarily include logic for deciding, with or without user input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular implementation. In particular, the terms “comprises” and“comprising” should be interpreted as referring to elements, components, or steps in a nonexclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

[0068] 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 medical device contexts that can benefit from certain attributes described herein.

[0069] 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.

[0070] 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.

[0071] 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 electrically conductive housing configured to be implanted beneath a skin portion of a recipient’s body; a transducer on or within the housing, the transducer configured to receive and / or to generate vibrations; an electrically insulative and biocompatible material overlaying the housing, the material configured to electrically insulate the housing and the transducer from the recipient’s body; and at least one vibration conduit configured to be in contact with the recipient’s body and to transfer the vibrations between the recipient’s body and the transducer, the at least one vibration conduit comprising a first portion covered by the material and a second portion not covered by the material.

2. The apparatus of claim 1, wherein the housing comprises an inner region hermetically sealed from an environment surrounding the housing, the inner region containing the transducer.

3. The apparatus of claim 1 or claim 2, wherein the housing comprises a biocompatible metal.

4. The apparatus of any preceding claim, wherein the transducer comprises a microphone configured to generate measurement signals in response to the vibrations received from the recipient’s body.

5. The apparatus of any of claims 1 to 4, wherein the transducer comprises an actuator configured to generate the vibrations in response to control signals and to provide the vibrations to a portion of the recipient’s body.

6. The apparatus of any preceding claim, wherein the material comprises silicone.

7. The apparatus of any preceding claim, wherein the transducer comprises a diaphragm beneath the material.

8. The apparatus of claim 7, wherein: the first portion is in contact with and extending from the diaphragm, the material overlaying the first portion; andthe second portion is electrically insulated from the first portion by the material, the second portion configured to transfer the vibrations between the recipient’s body and the first portion via the material.

9. The apparatus of claim 8, wherein the first portion is in electrical communication with the housing and the transducer, and the second portion is electrically insulated from the housing and the transducer by the material.

10. The apparatus of claim 8 or claim 9, wherein the second portion comprises: a first end portion comprising a recess configured to fit over the first portion and the material overlaying the first portion; and a second end portion configured to be in contact with a portion of the recipient’s body.

11. The apparatus of claim 7, wherein the at least one vibration conduit comprises an elongate member, the first portion of the at least one vibration conduit comprising a first end portion of the elongate member embedded within the material and the second portion of the at least one vibration conduit comprising a second end portion of the elongate member configured to be in contact with a portion of the recipient’s body, the first end portion spaced from the diaphragm with a region between the first end portion and the diaphragm containing the material.

12. The apparatus of claim 11, wherein the first end portion is spaced from the diaphragm.

13. The apparatus of claim 12, wherein a region between the first end portion and the diaphragm contains the material.

14. The apparatus of claim 11, wherein the first end portion comprises a substantially planar plate and a plurality of recesses configured to contain the material.

15. The apparatus of any of claims 11 to 14, wherein the material overlays at least a portion of the elongate member between the first end portion and the second end portion.

16. The apparatus of any preceding claim, wherein at least a portion of the at least one vibration conduit is electrically conductive and is not electrically insulated from the recipient’s body.

17. The apparatus of claim 16, wherein the portion of the at least one vibration conduit comprises titanium.

18. A method comprising: providing an implant comprising: an electrically conductive body; a device on or within the body, the device comprising a vibration sensor or a vibration generator on or within the body; an electrically insulative and biocompatible coating on the body, the coating configured to electrically isolate the body from tissue and / or fluid surrounding the body; and at least one elongate member, at least a portion of the at least one elongate member embedded within the coating, the at least one elongate member configured to transmit vibrations between the device and the tissue and / or fluid; affixing the body to a first portion of the tissue; and affixing an end portion of the at least one elongate member to a second portion of the tissue.

19. The method of claim 18, wherein said affixing the body to the first portion of the tissue is performed prior to said affixing the end portion to the second portion of the tissue.

20. The method of claim 18, wherein said affixing the body to the first portion of the tissue is performed after said affixing the end portion to the second portion of the tissue.

21. The method of any of claims 18 to 20, further comprising transmitting vibrations between the device and the second portion of the tissue via the at least one elongate member and the coating.

22. A system comprising: an electrically conductive body configured to be subcutaneously implanted within a recipient; and a diaphragm on or within the body, the diaphragm configured to receive vibrations from tissue of the recipient and / or to transmit vibrations to the tissue of the recipient;at least one elongate member comprising a first end portion in mechanical communication with the diaphragm and a second end portion configured to be affixed to the tissue; at least one electrically insulative layer substantially surrounding the body and the diaphragm and configured to electrically insulate the body and the diaphragm from the recipient; and at least one propagation path of the vibrations between the diaphragm and the tissue, the at least one propagation path extending from the second end portion of the at least one elongate member to the diaphragm and extending through at least some of the at least one electrically insulative layer.

23. The system of claim 22, wherein the at least one electrically insulative layer comprises silicone.

24. The system of claim 22 or claim 23, wherein at least a portion of the at least one electrically insulative layer between the diaphragm and the second end portion is sufficiently resilient to prevent hermeticity breaches through the at least one electrically insulative layer induced by radial forces applied to the second end portion.

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