Implantable assembly with flexible membrane

Abstract

An apparatus includes a chassis, a feedthrough, and a membrane having an outer perimeter portion affixed to the chassis and an inner perimeter portion affixed to the feedthrough. The membrane is configured to flex in response to a first force applied to the chassis and / or a second force applied to the feedthrough.

Description

IMPLANTABLE ASSEMBLY WITH FLEXIBLE MEMBRANEBACKGROUNDField

[0001] The present application relates generally to implantable devices for stimulation and / or measurement of a recipient’s body and the housings and / or feedthroughs of such devices.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 a chassis, a feedthrough, and a membrane having an outer perimeter portion affixed to the chassis and an inner perimeter portion affixed to the feedthrough. The membrane is configured to flex in response to a first force applied to the chassis and / or a second force applied to the feedthrough.

[0005] In another aspect disclosed herein, a method comprises applying an impulse to an implanted device comprising a housing, a connector, and at least one flexure having a first portion affixed to the housing and a second portion affixed to the connector. The impulse generates a differential force between the housing and the connector. The method further comprises dampening the differential force by deforming the at least one flexure.

[0006] In another aspect disclosed herein, an apparatus comprises a chassis, a feedthrough, and a deformable support having a substantially planar outer perimeter portion bonded to the chassis and an inner perimeter portion bonded to the feedthrough. A first region bounded by the chassis, feedthrough, and support is hermetically sealed from a second region outside the chassis, feedthrough, and support. The support comprises a plurality of bends such that one or more portions of the support between the outer perimeter portion and the inner perimeter portion are out-of-plane relative to the outer perimeter portion.BRIEF DESCRIPTION OF THE DRAWINGS

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

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

[0009] FIG. IB 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. 2A schematically illustrates a plan view of an example apparatus in accordance with certain implementations described herein;

[0011] FIGs. 2B-2E schematically illustrate cross-sectional views of portions of various example apparatus in accordance with certain implementations described herein; and

[0012] FIG. 3 is a flow diagram of an example method in accordance with certain implementations described herein.DETAILED DESCRIPTION

[0013] Certain implementations described herein provide an implant chassis having a preformed, flexible membrane bonded to a feedthrough and to a wall of the chassis to support the feedthrough. The membrane can comprise a thin sheet of material with aplurality of out-of-plane bends configured to deform (e.g., flex) such that the feedthrough can move or “float” relative to the chassis and the transfer of impact forces from the chassis to the feedthrough are reduced (e.g., minimized).

[0014] The teachings detailed herein are applicable, in at least some implementations, to any type of implantable stimulation or measurement system (e.g., implantable auditory prosthesis device or system; neurostimulation system; machine-brain interface system; muscle stimulation system). The system (e.g., implantable sensor prostheses; implantable stimulation system; implantable medicament administration system) can be configured to provide a portion of the recipient’s body with stimulation signals and / or medicament dosages from an implanted portion of the system in response to received information and / or control signals from an external portion of the system. The system (e.g., implantable sensing system) can be configured to provide sensor signals from an implanted portion of the system to an external portion of the 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 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.

[0015] Merely for ease of description, apparatus and methods disclosed herein are primarily described with reference to an illustrative medical device, namely an implantable transducer assembly 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, theteachings detailed herein and / or variations thereof can be utilized in other types of prostheses beyond auditory prostheses.

[0016] While systems and devices of certain implementations are described herein in the context of auditory prosthesis devices, certain other systems and devices in the context 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 also compatible with certain implementations described herein, including but are not limited to: vestibular devices (e.g., vestibular implants), tinnitus treatment devices, visual devices (e.g., bionic eyes), visual prostheses (e.g., retinal implants), neurostimulators, brain 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 or treatment systems; pain control systems; bladder control systems; sleep apnea control systems; neurostimulators; cardiac pacemakers; drug delivery systems; defibrillators; functional electrical stimulation devices; electroporation devices), to perform monitoring or measuring functionalities (e.g., sensors; electroencephalogram monitoring of brain function; electrocardiogram monitoring of heart function), seizure devices (e.g., devices for monitoring and / or treating epileptic events); swallowing treatment devices (e.g., devices 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); or other medical implants beyond sensory prostheses. Certain other implementations are compatible with types of devices (e.g., aeronautical, automotive, military, or other electronic devices) that can experience environmental conditions in which some flexibility of a feedthrough relative to a surrounding portion of a housing is beneficial.

[0017] FIG. 1A is a perspective view of an example cochlear implant auditory prosthesis 100 implanted in a recipient in accordance with certain implementations described herein. The example auditory prosthesis 100 is shown in FIG. 1 A 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 totallyimplantable 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 A with a subcutaneously implantable microphone assembly, as described more fully herein. In certain implementations, the example cochlear implant auditory prosthesis 100 of FIG. 1 A can be in conjunction with a reservoir of liquid medicament as described herein.

[0018] As shown in FIG. 1A, 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.

[0019] As shown in FIG. 1A, 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. 1A 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. 1A, 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 externalcoil 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.

[0020] 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 (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 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.

[0021] 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 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). Thestimulator 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.

[0022] 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.

[0023] The elongate electrode assembly 118 comprises a longitudinally aligned and distally extending array 146 of contacts or electrodes 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.

[0024] While FIG. 1A 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 (“HQ”). 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-canal microphone) implantable on or within the recipient, and can be referred to as a mostly implantable cochlear implant (“MIQ”).

[0025] FIG. IB 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. IB 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. IB 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 206 (e.g., a microphone 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 an energy storage device 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.

[0026] For the example auditory prosthesis 200 shown in FIG. IB, 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 certain implementations, the example auditory prosthesis 100, 200 shown in FIGs. 1A and IB can comprise an implantable microphone assembly, such as the microphone assembly 206 shown in FIG. IB. 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 certain implementations, 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.

[0027] The actuator 210 of the example auditory prosthesis 200 shown in FIG. IB is supportably connected to a positioning system 212, which in turn, is connected to a boneanchor 214 mounted in the recipient's mastoid bone (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).

[0028] 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 via wire 208 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.

[0029] 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.

[0030] The example auditory prostheses 100 shown in FIG. 1 A utilizes an external microphone 124 and the auditory prosthesis 200 shown in FIG. IB utilizes an implantable microphone assembly 206 comprising a subcutaneously implantable acoustic transducer. In certain implementations described herein, the auditory prosthesis 100 utilizes one or more implanted microphone assemblies on or within the recipient. In certain implementationsdescribed herein, the auditory prosthesis 200 utilizes one or more microphone assemblies that are positioned external to the recipient and / or that are implanted on or within the recipient, and utilizes one or more acoustic transducers (e.g., actuator 210) that are implanted on or within the recipient. In certain implementations, an external microphone assembly can be used to supplement an implantable microphone assembly of the auditory prosthesis 100, 200. Thus, the teachings detailed herein and / or variations thereof can be utilized with any type of external or implantable microphone arrangement, and the acoustic transducers shown in FIGs. 1 A and IB are merely illustrative.

[0031] FIG. 2A schematically illustrates a plan view of an example apparatus 300 in accordance with certain implementations described herein. FIGs. 2B-2E schematically illustrate cross-sectional views of portions of various example apparatus 300 in accordance with certain implementations described herein. The apparatus 300 comprises a chassis 310 (e.g., housing; casing; can), a feedthrough 320 (e.g., connector; electrical connector; optical connector; fluidic connector), and a membrane 330 (e.g., contoured sheet; support). The membrane 330 has an outer perimeter portion 332 affixed to the chassis 310 and an inner perimeter portion 334 affixed to the feedthrough 320. The membrane 330 is configured to flex in response to a first force Fj applied to the chassis 310 and / or a second force F2 applied to the feedthrough 320 (e.g., a differential force F between the chassis 310 and the feedthrough 320, the differential force F equal to the absolute value of the difference \Fi - F2I between the first force Fi and the second force F2).

[0032] In certain implementations, the apparatus 300 is configured to be implanted on or within a recipient’s body. For example, each of the chassis 310 and the feedthrough 320 can comprise at least one biocompatible material (e.g., titanium; titanium alloy; plastic; ceramic; glass) configured to contact tissue and / or fluid of the recipient’s body.

[0033] In certain implementations, the chassis 310, the feedthrough 320, and the membrane 330 hermetically seal a first region 340 within the apparatus 300 from a second region 342 surrounding the apparatus 300. The first region 340 can be configured to contain one or more transducers (e.g., acoustic transducers; mechanical - electrical transducers; microphone assembly 124, 202; actuator 210) and electronic circuitry (e.g., electronic circuit elements, including but not limited to one or more microprocessors, electrical insulation,electrical shielding; stimulation electronics; sound processing electronics) in operable communication with the feedthrough 320.

[0034] As shown in FIG. 2A, the chassis 310 can comprise a plurality of walls 312 at least partially bounding the first region 340 and that are substantially impenetrable to air and / or fluids from the second region 342. For example, for an implantable apparatus 300, the plurality of walls 312 can comprise a biocompatible material (e.g., metal; stainless steel; titanium; titanium-based alloy; cobalt-based alloy; magnesium-based alloy; tantalum-based alloy; non-metal; plastic; polymer; ceramic) or a non-biocompatible material coated with a biocompatible material. The plurality of walls 312 can be unitary (e.g., integral; monolithic) with one another with the plurality of walls 312 defining a periphery of the first region 340, or can have joint seams between at the edges of adjoined walls. In addition, the feedthrough 320 and the membrane 330 can also be substantially impenetrable to air and / or fluids from the second region 342.

[0035] In certain implementations, the apparatus 300 comprises an implantable portion of an auditory prosthesis (e.g., auditory prosthesis 100, 200; cochlear implant auditory prosthesis; middle ear auditory prosthesis; bone conduction auditory prosthesis) used by the recipient. For example, the apparatus 300 can comprise an acoustic transducer (e.g., external microphone; subcutaneously implantable microphone; microphone assembly 124) configured to detect acoustic vibrations and / or pressure changes from the second region 342 outside the apparatus 300 and to convert the detected vibrations and / or pressure changes into electrical signals. For another example, the apparatus 300 can comprise an implantable actuator (e.g., actuator 210) configured to be mechanically coupled to a portion of the recipient’s auditory system, to detect acoustic vibrations and / or pressure changes from at least a partially functional portion of the recipient’s auditory system (e.g., middle ear structures and / or cavities; inner ear structures and / or cavities) and to convert the detected vibrations and / or pressure changes into electrical signals. Circuitry within the apparatus 300 can be configured to receive the electrical signals from the acoustic transducer and / or the actuator (e.g., via the feedthrough 320) and to generate stimulation signals (e.g., acoustical vibrations; electrical stimulation signals) in response to the received electrical signals. For electrical stimulation signals, the apparatus 300 can be configured to provide the electrical stimulation signals to the recipient’s body via the feedthrough 320.

[0036] While FIG. 2A schematically illustrates an example chassis 310 that has a substantially parallelepiped shape (e.g., rectangular cuboid; rhombohedron), the chassis 310 can have any shape, including but not limited to: tubular; non-tubular; cylindrical; non- cylindrical; disc-shaped; geometric cross-sectional shapes (e.g., circular; elliptical; rectangular; square; polygonal); irregular cross-sectional shapes. While FIG. 2A schematically illustrates the example chassis 310 as having a plurality of substantially planar walls 312, in certain other implementations, one or more of the walls 312 can be non-planar (e.g., curved; bowed; concave; convex; bent; angled) and / or can have one or more protrusions or recesses. While FIG. 2A schematically illustrates the example chassis 310 having corners (e.g., 90 degrees) at edges of adjoined wall portions, in certain other implementations, the chassis 310 has a smooth contour (e.g., no corner) at the edges of adjoined wall portions.

[0037] In certain implementations, the feedthrough 320 comprises a body 322, at least one conduit 324 extending through the body 322, and a flange 326 (e.g., metallic portion) bonded to and extending around the body 322. The flange 326 is affixed to the inner perimeter portion of the membrane 330, and the at least one conduit 324 extends from the first region 340 to the second region 342. For example, the feedthrough 320 can be an electrical feedthrough in which the body 322 comprises an electrically insulative portion and the at least one conduit 324 comprises at least one electrical conductor 324 (e.g., wire; rod) extending through the electrically insulative portion from the first region 340 to the second region 342 and configured to transmit electrical signals between the first region 340 and the second region 342. For another example, the feedthrough 320 can be an optical feedthrough in which the body 322 comprises an optically opaque portion and the at least one conduit 324 comprises at least one optically transparent conduit (e.g., optical fiber; optical rod) extending through the optically opaque portion from the first region 340 to the second region 342 and configured to transmit optical signals between the first region 340 and the second region 342. For another example, the feedthrough 320 can be a fluidic (e.g., hydraulic; pneumatic) feedthrough in which the body 322 comprises a portion impermeable to at least one fluid and the at least one conduit 324 comprises at least one portion (e.g., tube; hole) permeable to the at least one fluid, extending through the impermeable portion from the first region 340 to the second region 342, and configured to transmit the at least one fluid between the first region 340 and the secondregion 342 (e.g., a medicament from the first region 340 to the second region 342; a body fluid sample from the second region 342 to the first region 340).

[0038] While FIG. 2A schematically illustrates an example feedthrough 320 that has a substantially circular outer perimeter, the outer perimeter of the feedthrough 320 can have any shape, including but not limited to: oval; elliptical; rectangular; square; polygonal; symmetric; asymmetric; geometric; irregular. While FIG. 2A schematically illustrates the example feedthrough 320 as being substantially planar, in certain other implementations, the feedthrough 320 (e.g., the body 322 and / or the flange 326) can be non-planar (e.g., curved; bowed; concave; convex; bent; angled) and / or can have one or more protrusions or recesses. While FIG. 2A schematically illustrates the example at least one conduit 324 having a right circular cylinder shape, in certain other implementations, the at least one conduit 324 can have any shape, including but not limited to, cylindrical with other cross-sectional shapes (e.g., oval; elliptical; rectangular; square; polygonal); non-cylindrical. While FIG. 2A schematically illustrates the example at least one conduit 324 comprising four conduits 324, in certain other implementations, the at least one conduit 324 can comprise 1, 2, 3, 5, 6 or more conduits 324. While FIG. 2A schematically illustrates the example conduits 324 arranged to be substantially equidistant from one another, in certain other implementations, different pairs of the conduits 324 can have different distances between the two conduits 324 of the pair.

[0039] In certain implementations, the membrane 330 comprises a sheet of biocompatible material (e.g., metal; stainless steel; titanium; titanium-based alloy; cobaltbased alloy; magnesium-based alloy; tantalum-based alloy; non-metal; plastic; polymer) or a sheet of material coated with a biocompatible material.

[0040] The membrane 330 can be affixed to a first wall 312a of the chassis 310 (e.g., welded; laser welded; soldered; brazed; held by adhesive; crimped; bonded) and affixed to the flange 326 of the feedthrough 320 (e.g., welded; laser welded; soldered; brazed; held by adhesive; crimped; bonded). The membrane 330 can comprise the same material as does the flange 326 of the feedthrough 320 and / or the same material as does the first wall 312a of the chassis 310 (e.g., to avoid galvanic corrosion), or the membrane 330 can comprise a different material than does the flange 326 and / or the first wall 312a.

[0041] The outer perimeter portion 332 of the membrane 330 can be affixed to an outer surface of the first wall 312a (e.g., a surface facing the second region 342 outside theapparatus 300; see, e.g., FIGs. 2B-2E), to an inner surface of the first wall 312a (e.g., a surface facing the first region 340 within the apparatus 300), and / or a side surface within an orifice extending through the first wall 312a. The inner perimeter portion 334 of the membrane 330 can be affixed to an outer surface of the flange 326 (e.g., a surface facing the second region 342 outside the apparatus 300; see, e.g., FIGs. 2B and 2C), to an inner surface of the flange 326 (e.g., a surface facing the first region 340 within the apparatus 300; see, e.g., FIGs. 2D and 2E), and / or a side surface of the flange 326. In certain implementations, the feedthrough 320 can be substantially coplanar with the first wall 312a (see, e.g., FIGs. 2B-2E), while in certain other implementations, the feedthrough 320 is substantially above or below the first wall 312a.

[0042] In certain implementations, the membrane 330 is contoured (e.g., preformed) and / or has a thickness such that the membrane 330 is more flexible than either the first wall 312a of the chassis 310 or the body 322 of the feedthrough 320. For example, the membrane 330 can have a sheet thickness that is less than a wall thickness of the first wall 312a of the chassis 310. The sheet thickness of the membrane 330 can be in a range less than 150 microns (e.g., in a range of 10 microns to 100 microns; in a range of 50 microns to 100 microns) and the first wall 312a can have a wall thickness in a range greater than or equal to 150 microns. The membrane 330 can comprise titanium with a sheet thickness in a range of 50 microns to 100 microns and can be affixed to the first wall 312a of the chassis 310, the first wall 312a comprising titanium with a wall thickness greater than 150 microns. While the membrane 330 of FIGs. 2B-2E has a substantially uniform thickness across the area of the membrane 330, in certain other implementations, the membrane 330 has a non-uniform thickness between the outer perimeter portion 332 and the inner perimeter portion 334.

[0043] In certain implementations, the membrane 330 comprises one or more angled and / or curved portions 336 (e.g., at least one flexure) configured to flex (e.g., elastically deform) in response to the first force and / or the second force such that the feedthrough 320 moves in at least one direction relative to the chassis 310. The one or more angled and / or curved portions 336 can be between the outer perimeter portion 332 and the inner perimeter portion 334. For example, as shown in FIGs. 2B-2E, the outer perimeter portion 332 can be substantially planar and bonded to the first wall 312a of the chassis 310, the inner perimeter portion 334 can be substantially planar and bonded to the flange 326 of the feedthrough 320, and the one or more angled and / or curved portions 336 can extend from the outer perimeterportion 332 to the inner perimeter portion 334. In certain implementations, the membrane 330 is substantially symmetric (e.g., circularly symmetric about an axis at a center of the membrane 330 and extending in a direction substantially perpendicular to the membrane 330; see, e.g., FIG. 2A), while in certain other implementations, the membrane 330 is asymmetric (e.g., having different contours in different radial directions substantially parallel to the membrane 330).

[0044] As schematically illustrated by FIG. 2B, the one or more angled and / or curved portions 336 have a single corrugation (e.g., local extremum) between the outer perimeter portion 332 and the inner perimeter portion 334, the corrugation extending in a direction substantially perpendicular to the outer perimeter portion 332 (e.g., substantially perpendicular to the first wall 312a). As schematically illustrated by FIG. 2C, the one or more angled and / or curved portions 336 have multiple corrugations (e.g., local extrema) between the outer perimeter portion 332 and the inner perimeter portion 334, the corrugations extending in a direction substantially perpendicular to the outer perimeter portion 332 (e.g., substantially perpendicular to the first wall 312a). As schematically illustrated by FIG. 2D, the one or more angled and / or curved portions 336 comprise multiple angles which give the membrane 330 a cross-sectional shape in a plane substantially perpendicular to the outer perimeter portion 332 (e.g., substantially perpendicular to the first wall 312a) that is monotonic between the outer perimeter portion 332 and the inner perimeter portion 334. As schematically illustrated by FIG. 2E, the one or more angled and / or curved portions 336 have multiple corrugations (e.g., local extrema) between the outer perimeter portion 332 and the inner perimeter portion 334, the corrugations extending in a direction substantially parallel to the outer perimeter portion 332 (e.g., substantially parallel to the first wall 312a).

[0045] In certain implementations, the membrane 330 allows the feedthrough 320 to move relative to the chassis 310 in at least one direction in which the differential force AF has a non-zero component. For example, the membrane 330 can allow the feedthrough 320 to move relative to the chassis 310 in a first direction substantially parallel to the outer perimeter portion 332 (e.g., substantially parallel to the first wall 312a) in response to a non-zero differential force component AF between the chassis 310 and the feedthrough 320 in the first direction and / or to move relative to the chassis 310 in a second direction substantially perpendicular to the outer perimeter portion 332 (e.g., substantially perpendicular to the firstwall 312a) in response to a non- zero differential force component AF between the chassis 310 and the feedthrough 320 in the second direction.

[0046] FIG. 3 is a flow diagram of an example method 400 in accordance with certain implementations described herein. While the example method 400 is described herein by referring to the example apparatus 300 of FIGs. 2A-2E, other apparatuses are also compatible with the example method 400 in accordance with certain implementations described herein.

[0047] In an operational block 410, the method 400 comprises applying an impulse (e.g., force applied over a time period) to an implanted device (e.g., apparatus 300; implanted portion of an auditory prosthesis system) comprising a housing (e.g., chassis 310), a connector (e.g., electrical connector; optical connector; fluidic connector; feedthrough 320), and at least one flexure (e.g., one or more bends of a preformed, deformable membrane 330). The at least one flexure has a first portion (e.g., outer perimeter portion 332) affixed to the housing and a second portion (e.g., inner perimeter portion 334) affixed to the connector. The impulse generates a differential force A F between the housing and the connector.

[0048] In certain implementations, the impulse is applied to the housing (e.g., via an external force impacting the housing), while in certain other implementations, the impulse is applied to the connector (e.g., via an external force impacting the connector). For example, applying the impulse can comprise, over a time period, applying a first force to the housing and applying a second force to the connector, the second force different from the first force (e.g., one of the first and second forces is non-zero and the other of the first and second forces is substantially equal to zero; both the first and second forces are non-zero and having different magnitudes and / or directions). As a result of the differential force between the housing and the connector, the housing and / or the connector move relative to one another (e.g., the housing moving relative to the connector which remains substantially stationary due to inertia; the connector moving relative to the housing which remains substantially stationary due to inertia).

[0049] In an operational block 420, the method 400 further comprises dampening the differential force by deforming the at least one flexure. The dampening of the differential force can comprise reducing the differential force to maintain structural integrity of the connector and / or the housing. For example, the deforming can comprise elastic bending such that the differential force is dampened by other forces (e.g., friction) occurring as a result ofthe elastic bending. For another example, the bending can comprise plastic bending or other deformations such that the differential force is dampened by forces occurring within the at least one flexure (e.g., the at least one flexure acting as a “crumple zone” to absorb at least some of the differential force).

[0050] In certain implementations, the method 400 further comprises allowing the connector to move relative to the housing in response to the impulse. For example, the at least one flexure can be more flexible than the housing and the connector, and the flexibility of the at least one flexure can be sufficient to allow the connector to “float” relative to the housing (e.g., to move with at least one motion component substantially parallel to the wall 312a and / or with a motion component substantially perpendicular to the wall 312a). Due to the at least one flexure, impact forces applied to the housing are not transferred from the housing to the connector or from the connector to the housing. In certain implementations, the housing, connector, and at least one flexure are resistant to impacts up to 2.5 Joules (e.g., up to 3 Joules; up to 4 Joules; up to 5 Joules). For example, during implantation or operation, the implanted device can be exposed to differential forces between the housing and the connector (e.g., having a brittle ceramic portion). The at least one flexure can be configured to dissipate the differential forces (e.g., tensile or compressive forces from impacts on the housing and / or inertia and impulses applied to the housing and / or connector), thereby protecting the connector from forces that would otherwise cause damage (e.g., breakage) and / or cause detachment of the connector from components within the housing.

[0051] 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 userinput 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.

[0052] 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 conventional cochlear implants, 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.

[0053] 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.

[0054] 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 circuit from one another), and the ordinal adjective is not used to denote an order of these elements or of their use.

[0055] 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: a chassis; a feedthrough; and a membrane having an outer perimeter portion affixed to the chassis and an inner perimeter portion affixed to the feedthrough, the membrane configured to flex in response to a first force applied to the chassis and / or a second force applied to the feedthrough.

2. The apparatus of claim 1, wherein the apparatus is configured to be implanted on or within a recipient’s body.

3. The apparatus of claim 1 or claim 2, wherein the chassis, the feedthrough, and the membrane hermetically seal a first region within the apparatus from a second region surrounding the apparatus.

4. The apparatus of claim 3, wherein the feedthrough comprises an electrically insulative portion, at least one electrical conductor extending through the electrically insulative portion, and a metallic portion bonded to and extending around the electrically insulative portion, the metallic portion affixed to the inner perimeter portion of the membrane, the at least one electrical conductor extending from the first region to the second region.

5. The apparatus of any of claims 1 to 4, wherein the membrane comprises one or more angled and / or curved portions configured to flex in response to the first force and / or the second force such that the feedthrough moves in at least one direction relative to the chassis.

6. The apparatus of claim 5, wherein the outer perimeter portion of the membrane is substantially planar.

7. The apparatus of claim 6, wherein the at least one direction is substantially perpendicular to the outer perimeter portion and / or substantially parallel to the outer perimeter portion.

8. The apparatus of claim 6 or claim 7, wherein a cross-sectional shape of the membrane in a plane substantially perpendicular to the outer perimeter portion is monotonic between the outer perimeter portion and the inner perimeter portion.

9. The apparatus of claim 6 or claim 7, wherein a cross-sectional shape of the membrane in a plane substantially perpendicular to the outer perimeter portion comprises one or more corrugations between the outer perimeter portion and the inner perimeter portion.

10. The apparatus of any preceding claim, wherein the membrane has a thickness less than or equal to 150 microns.

11. A method comprising: applying an impulse to an implanted device comprising a housing, a connector, and at least one flexure having a first portion affixed to the housing and a second portion affixed to the connector, the impulse generating a differential force between the housing and the connector; and dampening the differential force by deforming the at least one flexure.

12. The method of claim 11, wherein the implanted device comprises an implanted portion of an auditory prosthesis system.

13. The method of claim 11 or claim 12, wherein applying the impulse comprises applying the impulse to the connector.

14. The method of claim 11 or claim 12, wherein applying the impulse comprises applying the impulse to the housing.

15. The method of any of claims 11 to 14, wherein dampening the differential force comprises reducing the differential force to maintain structural integrity of the connector.

16. The method of any of claims 11 to 15, wherein said deforming comprises elastic bending and / or plastic bending.

17. The method of any of claims 11 to 16, further comprising allowing the connector to move relative to the housing in response to the impulse.

18. An apparatus comprising: a chassis; a feedthrough; and a deformable support having a substantially planar outer perimeter portion bonded to the chassis and an inner perimeter portion bonded to the feedthrough such that a first region bounded by the chassis, feedthrough, and support is hermeticallysealed from a second region outside the chassis, feedthrough, and support, the support comprising a plurality of bends such that one or more portions of the support between the outer perimeter portion and the inner perimeter portion are out-of-plane relative to the outer perimeter portion.

19. The apparatus of claim 18, wherein the plurality of bends are configured to flex in response to a differential force applied between the chassis and the feedthrough.

20. The apparatus of claim 18 or claim 19, wherein the plurality of bends have sufficient flexibility to allow the feedthrough to float relative to the chassis.

21. The apparatus of any of claims 18 to 20, wherein the support comprises a sheet of material having a thickness less than 150 microns.

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