US20130096366A1

Movatterモバイル変換

Info

Publication number: US20130096366A1
Application number: US13/271,909
Authority: US
Inventors: Wim Bervoets; Patrik KENNES; Bart Carpentier; Marcus ANDERSSON
Original assignee: Cochlear Ltd
Current assignee: Cochlear Ltd
Priority date: 2011-10-12
Filing date: 2011-10-12
Publication date: 2013-04-18
Also published as: US20190289412A1; US11889272B2; WO2013054312A1

Abstract

An implant configured for secured implantation into a recess formed in a recipient's bone and to removably retain a separate component in a compartment thereof such that the separate component is removable from the implant without removing the implant from the bone.

Description

BACKGROUND

1. Field of the Invention

The present invention relates generally to implantable medical devices.

Conductive hearing loss occurs when the normal mechanical pathways that provide sound to hair cells in the cochlea are impeded, for example, by damage to the ossicular chain or ear canal. Individuals suffering from conductive hearing loss may retain some form of residual hearing because the hair cells in the cochlea may remain undamaged.

Individuals suffering from conductive hearing loss typically receive an acoustic hearing aid. Hearing aids rely on principles of air conduction to transmit acoustic signals to the cochlea. In particular, a hearing aid typically uses a component positioned in the recipient's ear canal or on the outer ear to amplify a sound received by the outer ear of the recipient. This amplified sound reaches the cochlea causing motion of the perilymph and stimulation of the auditory nerve.

In contrast to hearing aids, certain types of hearing prostheses commonly referred to as bone conduction devices, convert a received sound into mechanical vibrations. The vibrations are transferred through the skull to the cochlea causing generation of nerve impulses, which result in the perception of the received sound. Bone conduction devices may be a suitable alternative for individuals who cannot derive sufficient benefit from acoustic hearing aids, cochlear implants, etc.

Some medical devices, such as transcutaneous bone conduction devices, have one or more components implanted in the recipient. Sometimes, the implanted components are secured to tissue of the recipient, sometimes they are attached to bone, and sometimes they are implanted (attached or otherwise) in a recess formed in the bone.

SUMMARY

In one aspect of the present invention, there is an implant comprising a compartment, wherein the implant is configured for secured implantation into a recess formed in a recipient's bone, and wherein the compartment is configured to removably retain a separate component such that the separate component is removable from the compartment without removing the implant from the bone.

In another aspect of the present invention, there is an implantable component, comprising a compartment and a vibratory element of a transcutaneous bone conduction device positioned in the compartment, wherein the implantable component is configured to be totally subcutaneously implanted in a recess formed in the recipient's bone.

In another aspect of the present invention, there is a medical procedure, comprising obtaining access to an implant totally subcutaneously implanted in a recipient, wherein at least a portion of at least a first component of the implant is located in a recess in bone and is osseointegrated to the bone, while the at least first component is located in the recess and is osseointegrated to the bone, detaching a second component from the first component, while the at least first component is located in the recess and is osseointegrated to the bone, removing the second component from within the recipient while the at least first component is located in the recess and is osseointegrated to the bone, and while the at least first component is located in the recess and is osseointegrated to the bone, reattaching the second component or attaching a third component to the first component such that the second component or the third component is subcutaneously implanted in the recipient.

In another aspect of the present invention, there is an implantable device, comprising a component configured to be removably retained in a compartment of an implant such that the component is removable from the compartment without moving the implant relative to an organ of a recipient proximate the implant.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present invention are described herein with reference to the attached drawing sheets in which:

FIG. 1 is a perspective view of a transcutaneous bone conduction device in which embodiments of the present invention may be implemented;

FIG. 2A is a top perspective view of an exemplary implant;

FIG. 2B is an isometric view of the exemplary implant ofFIG. 2A;

FIG. 2C is a side perspective view of the exemplary implant ofFIG. 2A;

FIG. 2D is a side perspective view of an alternate exemplary implant;

FIG. 3 is a top perspective view of an alternate exemplary implant;

FIG. 4 is a side perspective view of an alternate exemplary implant;

FIG. 5A is a perspective view of the exemplary implant ofFIG. 2A implanted in the skull;

FIG. 5B is a perspective view of the exemplary implant ofFIG. 2A implanted in the skull in a different manner than that ofFIG. 5A;

FIG. 6 is an isometric view of an exemplary recess within the skull;

FIG. 7A is a side perspective view of an exemplary module configured to interface with the alternate exemplary implant ofFIG. 2D;

FIG. 7B is a top view of the exemplary module ofFIG. 7A;

FIG. 7C is a side perspective view of the exemplary module ofFIG. 7A received in the implant ofFIG. 7A;

FIG. 8 is a flowchart illustrating a procedure to remove an implanted module and replace the module or implant with a new module;

FIG. 9 is side perspective view of a rounded contact of a fixation arm;

FIG. 10 is a side perspective view of a module having a vibratory element;

FIG. 11 is a side perspective view of an implant having a hood;

FIG. 12 is a side perspective view of an alternate embodiment of an implant having a hood; and

FIG. 13 is perspective view of an implantable component in the form of an active transcutaneous bone conduction device.

DETAILED DESCRIPTION

According to an exemplary embodiment, there is an implant comprising a substantially flat base with a circular periphery and a sidewall extending orthogonally therefrom. The combination of the base and the sidewall form a compartment with an opening opposite the base. The implant is configured for implantation into a recess formed in a recipient's skull and securement thereto via osseointegration. The implant is configured to removably receive in the compartment a separate implantable component, such as a module containing a vibrating actuator of a transcutaneous bone conduction device, such that the separate implantable component is removable from the implant without detaching the housing from the skull.

According to another exemplary embodiment, there is an implantable medical device including an implant which contains a functional component of the implantable medical device, such as a vibrating actuator of a transcutaneous bone conduction device. The implant comprises an enclosure in which the functional component is contained. The implant is configured for implantation into a recess formed in a recipient's bone and osseointegration thereto. In this exemplary embodiment, the implant is a monolithic structure that forms a hermetic enclosure that hermetically isolates the functional component from an external environment of the implant.

FIG. 1 is a perspective view of a transcutaneousbone conduction device100 in which embodiments of the present invention may be implemented. As shown, the recipient has anouter ear101, amiddle ear102 and aninner ear103. Elements ofouter ear101,middle ear102 andinner ear103 are described below, followed by a description ofbone conduction device100.

In a fully functional human hearing anatomy,outer ear101 comprises anauricle105 and anear canal106. A sound wave oracoustic pressure107 is collected byauricle105 and channeled into and throughear canal106. Disposed across the distal end ofear canal106 is atympanic membrane104 which vibrates in response toacoustic wave107. This vibration is coupled to oval window orfenestra ovalis110 through three bones ofmiddle ear102, collectively referred to as theossicles111 and comprising themalleus112, theincus113 and thestapes114. Theossicles111 ofmiddle ear102 serve to filter and amplifyacoustic wave107, causingoval window110 to vibrate. Such vibration sets up waves of fluid motion within cochlea139. Such fluid motion, in turn, activates hair cells (not shown) that line the inside of cochlea139. Activation of the hair cells causes appropriate nerve impulses to be transferred through the spiral ganglion cells andauditory nerve116 to the brain (not shown), where they are perceived as sound.

FIG. 1 also illustrates the positioning ofbone conduction device100 relative toouter ear101,middle ear102 andinner ear103 of a recipient ofdevice100. As shown,bone conduction device100 is positioned behindouter ear101 of the recipient. It is noted that in other embodiments, thebone conduction device100 may be located at other positions on the skull.Bone conduction device100 comprises anexternal component140 andimplantable component150.External component150 is located beneathskin132, and partially or fully belowadipose tissue128 and/ormuscle tissue128. Thebone conduction device100 includes asound input element126 to receive sound signals.Sound input element126 may comprise, for example, a microphone, telecoil, etc. In an exemplary embodiment,sound input element126 may be located, for example, on or inbone conduction device100, on a cable or tube extending frombone conduction device100, etc. Alternatively,sound input element126 may be subcutaneously implanted in the recipient, or positioned in the recipient's ear.Sound input element126 may also be a component that receives an electronic signal indicative of sound, such as, for example, from an external audio device. For example,sound input element126 may receive a sound signal in the form of an electrical signal from an MP3 player electronically connected to soundinput element126.

Bone conduction device

100 comprises a sound processor (not shown), an actuator (also not shown) and/or various other operational components. In operation,sound input device126 converts received sounds into electrical signals. These electrical signals are utilized by the sound processor to generate control signals that cause the actuator to vibrate. In other words, the actuator converts the electrical signals into mechanical vibrations for delivery to the recipient's skull.

In accordance with embodiments of the present invention, afixation system162 may be used to secureimplantable component150 toskull136. As described below,fixation system162 may include an implant at least partially embedded in theskull136.

In one arrangement ofFIG. 1,bone conduction device100 is a passive transcutaneous bone conduction device. That is, no active components, such as the actuator, are implanted beneath the recipient'sskin132. In such an arrangement, the active actuator is located inexternal component140, andimplantable component150 includes a movable component as will be discussed in greater detail below. The movable component of theimplantable component150 vibrates in response to vibration transmitted through the skin, mechanically and/or via a magnetic field, that are generated by an external magnetic plate.

In another arrangement ofFIG. 1,bone conduction device100 is an active transcutaneous bone conduction device where at least one active component, such as the actuator, is implanted beneath the recipient'sskin132 and is thus part of theimplantable component150. As described below, in such an arrangement,external component140 may comprise a sound processor and transmitter, whileimplantable component150 may comprise a signal receiver and/or various other electronic circuits/devices.

FIGS. 2A,2B and2C depict anexemplary implant210 usable in thefixation system162 detailed above withimplantable component150. Theimplant210 illustrated includes abase212 andsidewall214 extending orthogonally from thebase212. Thebase212 andsidewall214 of thehousing100 form anopen compartment220. Thecompartment220 is configured to house components of the implantablemedical device150 as will be described further below. The exterior portions of thesidewall214 and/or the base212 are configured to interact with a recess formed in the skull as will be described further below. Extending from the outer perimeter ofsidewall214 are threefixation arms230 configured with respective throughholes232 through which a bone screw may be inserted for additional bone fixation capability, also as will be described further below. In some embodiments, aflange216 extends about the perimeter of thesidewall214 at the top of thesidewall214, as may be seen by way of example inFIG. 2D, which depicts a derivative ofimplant210 in the form ofimplant210a. In embodiments that include fixation arm(s)230, the fixation arms may have the same thickness as theflange216, as depicted inFIG. 2D or may have a different thickness. In an exemplary embodiment, the bottom surface of theflange216 lies substantially flush on the top of the skull.

It is noted that in some exemplary embodiments, there is no base212 or apartial base212. That is, there is an opening at the bottom of theimplant210. Alternatively or in addition to this, some or all of the base212 may comprise a thin flexible diaphragm extending fromsidewalls214 and/or from an inner boundary of thepartial base212.

As may be seen fromFIGS. 2A-2D, theimplant210 may be in the form of a circular cylinder. More specifically, theimplant210 may have a circular cross-section on a plane normal to the longitudinal axis. In other embodiments, the implant may be in the form of another configuration, such as animplantable receiver housing310 having a square cross-section on a plane normal to the longitudinal axis as may be seen inFIG. 3, etc. Also, while the embodiment depicted inFIGS. 2A-2C has a relativelyflat base212 that extends orthogonally from thesidewall214, other embodiments include animplantable receiver housing410 that has a base412 that extends away from thesidewall414 at an angle such as that seen inFIG. 4. Any configuration of the implant may be used providing it permits at least some embodiments to be practiced.

In an exemplary embodiment, the

implant

210,310 and/or410 (hereinafter, unless otherwise specified, reference to one implant corresponds to the other implants and variations thereof) is made of titanium or other suitable metal or metal alloy. Theimplant210 is a monolithic component which may be obtained via a casting method, metal/plastic stamping method, machining method, etc. In some embodiments theimplant210 is made of metal and/or a metal alloy, plastic (e.g., polyether ether ketone PEEK™), etc. Any suitable material that will permit embodiments to be practiced as detailed herein may be used in some embodiments. In other embodiments, theimplant210 is an assembly. For example,implant210 may be a weldment where thebase212 and thesidewall214 are welded together. Still further by example, theimplant210 may be a fitment where thebase212 and thesidewall214 are screwed together (theimplant210 may have a seal or the like at the mating sections of the212 and thesidewall214 to obtain a hermetic seal at that location, as will be described more generally below). Any system or method of making the implant may be used, and the implant may take any form, providing it permits at least some embodiments to be practiced.

In an exemplary embodiment, at least some of the outer surfaces ofbase212 and/orsidewall214 form a bone interface region. In an exemplary embodiment where theimplant210 is fully implanted into theskull136, as depicted by way of example inFIG. 5a, all of the outer surfaces ofbase212 and all of the side surfaces of thesidewall214 form a bone interface region, as may be seen.FIG. 5A also depicts the use of bone screws501 which penetrate throughholes232 inarms230, as will be discussed further below. In another exemplary embodiment where theimplant210 is partially implanted into theskull136, as depicted by way of example inFIG. 5b, all of the outer surfaces ofbase212 and a portion of the side surfaces of thesidewall214 form a bone interface region, as may be seen.

As mentioned above, theimplant210 is configured to sit in a recess in theskull136 as opposed to on the top of the skull. That is, some or all of theimplant210 extends below an extrapolated profile of the skull (i.e., where the surface of the skull would be/was prior to forming the recess in the skull).FIGS. 5A and 5B depict

exemplary recesses

137aand137b, respectively. As may be seen fromFIG. 5A, therecess137aincludes a portion to receivefixation arms230. However, in an alternate embodiment, where theimplant210 is partially implanted into theskull136, such as shown inFIG. 5B, the receiver may not include a portion to receivefixation arms230, at least in embodiments where theimplant210 is implanted to a depth such that the bottom of thefixation arms230 remain above (including flush) with the outer surface of theskull136.FIG. 6 depicts an isometric view of anexemplary implant137acorresponding to, for example, implant210a, fitted into an exemplary recess inskull136. The exemplary recess includes a portion to receivefixation arms230 and a portion to receiveflange216. In an exemplary embodiment, implant210ais configured to be partially implanted into a recess such that a portion (approximately ½, ⅓, ⅔, ¾, ¼, etc.) of the thickness of theflange216 in the longitudinal direction of theimplant210aextends above the outer surface of theskull136.

In an exemplary embodiment, theimplant210 rests on/in the recess formed in the skull. The bone interface surface of theimplant210 is configured to osseointegrate with the bone with which it interfaces. In an exemplary embodiment, the bone interface surface has an osseointegration enhancing surface that may be textured, the texture improving osseointegration. Further, the bone interface surface may be coated with an osseointegration enhancing substance. In an exemplary embodiment, the bone interface surface has an anti-microbial (including anti-bacterial) that inhibits (including prevents) microbial growth and/or attachment thereon. Further, the bone interface surface may be coated with an anti-microbial substance that inhibits microbial growth and/or attachment thereon. In an exemplary embodiment, the portions of theimplant210 that make up the bone interface surface may be made of any material that has a known ability to integrate into surrounding bone tissue.

In an exemplary embodiment, theimplant210 is not fixed at essentially one central point to the skull, in contrast to, for example, a percutaneous bone conduction device that utilizes a bone fixture (also referred to as a bone screw) coupled to a skin penetrating abutment, and/or in contrast to an active or passive transcutaneous bone conduction device that utilizes a vibratory element linked to a bone fixture (bone screw) embedded in the skull. In an exemplary embodiment, the bone interface surface of, for example, thebase212 is expansive, and all or effectively all of the exterior surface of the base212 may be osseointegrated to the skull. Alternatively or in addition to this, in some embodiments, all or substantially all of the bone interface surface of thesidewalls214 may also be osseointegrated to the skull to provide for substantially more mechanical support and stability relative to a fixation system utilizing a single central point. Further, the expansive bone interface surface of the base and/or the expansive bone interface surface of the sidewalls (which has a relatively large area owing to the fact that the area is linked to the radius of the base) provides for substantially much more mechanical support and stability relative to the fixation systems utilizing a single central point. In an exemplary embodiment, some or all of these features provide for an implant in which there is relatively little to no lever action, and at least substantially little to no lever action relative to the above-mentioned fixation systems utilizing a single central point (especially the percutaneous bone conduction device). In an exemplary embodiment, some or all of the exterior surface of thebase212 and/or some or all of the bone interface surfaces of thesidewalls214 have a roughened part that enhances osseointegration relative to a non-roughened part. Alternatively or in addition to this, in an exemplary embodiment, some or all of the exterior surface of thebase212 and/or some or all of the bone interface surfaces of thesidewalls214 have a coating of hydroxyapatite or other osseointegration-enhancing material that enhances osseointegration relative to a non-coated part.

As noted above, an exemplary embodiment utilizing the implants detailed herein corresponds to a transcutaneous bone conduction device. An embodiment includes stimulating and/or enhancing an osseointegration process via the use of a healing vibration mode whereby the transcutaneous bone conduction device is vibrated at a given frequency and cycle. In an exemplary embodiment, a vibrating element located in the implant may be used to stimulate/vibrate the bone in this healing vibration mode to improve osseointegration (e.g., shorten a time period to obtain a level of osseointegration relative to the time period to obtain that level without the healing mode and/or improve the level of osseointegration in a given time period relative to that which would be obtained in that same time period without the healing mode) of the implant with the bone. Such improved osseointegration may improve hearing quality and/or allow a faster application of normal use of the hearing prosthesis of which the implant is apart. In an exemplary embodiment, a sensor located in the compartment may generate a feedback signal which may be detected by an external component regarding the quality of osseointegration at a given time.

In an exemplary embodiment, theimplant210 is configured to be held within a recess in the skull without positive mechanical retention. In such an exemplary embodiment, osseointegration of the bone interface surface with the skull holds theimplant210 within the recess. In such an exemplary embodiment, a slight interference fit may be relied on where the outer diameter of thesidewall214 is slightly larger than the corresponding inner diameter of the recess. In an alternate embodiment, positive mechanical retention may be used to hold theimplant210 within the recess. By way of example, the exterior of thesidewall214 and/or the base230 may include male threads, grooves, etc., that interface with corresponding female threads, grooves, etc., to enhance securement of theimplant210 within the recess. In an exemplary embodiment, theimplant210 may be configured to snap-fit into the recess. By way of example, a male or female portion of theimplant210 may elastically deform to snap into a corresponding female or male portion of theskull136 made by removing a portion of theskull136. As will be further detailed below,fixation arms230 with bone screws may be used to provide positive mechanical retention. In an alternate embodiment, the recess is provided with an offset relative to the dimensions of the implant. Any device, system or method that may be used to adhere theimplant210 in the recess in a manner sufficient to permit at least embodiments detailed herein and variations thereof to be practiced may be used in some embodiments.

In an exemplary embodiment, a healthcare provider (e.g., a surgeon or other type of medical doctor, a registered nurse practitioner, a surgeon technician, etc.) creates a predefined recess within theskull136. In an exemplary embodiment, the healthcare provider identifies a type of implant receiver housing to be implanted (e.g.,implant receiver housing210,implant receiver housing210a, etc.) and determines the geometry of the recess to be created. In this exemplary embodiment,implant receiver housing210ais selected, and the healthcare provider creates a recess in theskull136 corresponding to the recess associated withFIG. 6 and/or any of the other recesses detailed herein and variations thereof. This may be accomplished utilizing a customized bone drill-tool/skull drill-tool which reproduces a given geometry of a recess that accepts a given geometry of theimplant receiver housing210, including recesses spaced at 120 degree intervals to receive at least a portion of thefixation arms230. Other intervals may be used as well with evenly spaced intervals (for fewer or more arms) or otherwise. By way of example, this customized bone drill-tool permits the creation of a recess in a precise and repeatable way.

The healthcare provider performs this skull recession action until a clean dura surface in the skull is obtained for the compete footprint of the intended implant, at least with respect to those portions of the implant to be located below the natural surface of the skull. It is noted that in some embodiments, instead of drilling to the dura of the skull, the recess could be less deep. The dimensions of the recess are based on the dimensions and depth of theimplant210. For example, if theimplant210 has a height (as measured along the longitudinal axis) of 4.0 mm and theimplant210 is configured to be fully implanted in theskull136, then the depth of the recess may be 4.0 mm or more. Conversely, if theimplant210 has a height of 4.00 mm and theimplant210 is configured to be partially implanted in theskull136, then the depth of the recess may be, by way of example, about 0.5 to about 2.0 mm. In an exemplary embodiment, such recess depths may be used in infant and/or child skulls which are typically not as thick as adult skulls.

The dimensions (e.g., shape, size) of the recess may be based on the dimensions of theimplant210. Any applicable dimensions of the recess and/or theimplant210 may be used in some embodiments so long as embodiments may be adequately practiced.

An alternate embodiment of the implant includes a central fixation device extending from the base of the implant. The central fixation device may be a screw that screws into a bone fixture located in the skull. As its name implies, the central fixation device may be located approximately at the center of the implant, while in other embodiments, it may be located away from the center of the implant. It is noted that in embodiments utilizing a central fixation device, the bone fixture may be implanted in a prior procedure to that of the implantation of the implant so as to provide a sufficient amount of time for the skull to heal from the first procedure and/or for the bone fixture to osseointegrate with the skull.

As noted above, theimplant210 includes acompartment220 that is open on the side facing away from theskull136. In an exemplary embodiment, thecompartment220 is configured to removably receive and removably retain a modular component of the implantable component in thecompartment220. An exemplary embodiment of amodule750 of which theimplant210ais configured to receive will be discussed in greater detail below. However, discussion will now be centered on exemplary retention mechanisms used with theimplant210ato removably retainably receive themodule750 therein and features of themodule750 which are used to insert and/or remove the module from the implant. By removably retainably receive, it is meant that themodule750 may be removed at least without having to structurally damage the implantedimplant210 or its securement to the skull. In this regard,module750 may correspond to a component configured to be removably retained incompartment220 ofimplant210asuch that the component is removable from thecompartment220 without moving theimplant210a, including relative to bone136 (or another organ)/removing the implant from the bone136 (or another organ) of a recipientproximate implant210a.

Referring toFIG. 7A, a side-view of theexemplary module750 is depicted above an exemplary implant (in this example, implant210a).FIG. 7B depicts a top view of the exemplary module750 (without reference to an implant). Theimplant210aincludes an internal fixture mechanism that permits the module750 (or other implantable components placed in the compartment220) to connect securely to theimplant210a. The internal fixture mechanism may be a locking mechanism or the like that secures the components to the implant. The internal fixture mechanism may be located on thesidewall214 and/or on thebase212. The internal fixture mechanism may comprise screw threads. For example, theimplant210amay includefemale threads217 located onsidewall214.Threads217 interface/interact with respectivemale threads751 located on the perimeter ofmodule750, thereby removably retaining themodule750 in thecompartment220. Accordingly,module750 may be screwed intocompartment220 ofimplant210a.Module750 includes twodepressions760 located on the top surface thereof, although more or fewer depressions may be used in other embodiments. These depressions permit a healthcare professional to more easily transfer removal and/or installation torque from his or her fingers to themodule750. In an exemplary embodiment, these depressions or other depressions are configured to accept prongs of a specialized wrench to fit therein, thereby permitting removal and/or installation torque to be more easily transferred to themodule750. In an alternate embodiment, studs and/or prongs onmodule750 may be used in lieu of or in addition todepressions760 to apply installation/removal torque to themodule750. It is noted that in such an exemplary embodiment, theimplant210ais configured to be attached to theskull136 in a manner that permits the installation and/or removal torques to be applied to themodule750 without dislodging theimplant210afrom the skull. Accordingly, in an exemplary embodiment,module750 includes a tool interface portion (depressions760, studs, etc.) configured to interact with and react to at least one of force (which may be applied in an embodiment where themodule750 snap fits intocompartment220, discussed in greater detail below) or torque applied to themodule750, where the least one of the force or the torque corresponds to a force or torque sufficient to remove themodule750 from thecompartment220 after themodule750 has been removably retained therein.Module750 further includes adome770. As will be described below,dome770 or a comparable arched or partially arched structure is configured to provide protection from an external impact to themodule750.

In an exemplary embodiment, instead of the aforementioned male-female thread arrangement, a snap-fit arrangement, press-fit arrangement and/or an interference fit arrangement is used to couplemodule750 to implant210a. In this regard, thecompartment220 may correspond to a female part of a snap coupling between themodule750 and theimplant210a. In an exemplary embodiment, instead of the aforementioned male-female thread arrangement, a bayonet fitting arrangement is used to couplemodule750 to implant210a. Any device, system or method that will permitmodule750 to be attached to implant210athat permits at least some embodiments detailed herein and variations thereof to be practiced may be utilized in some embodiments. In an exemplary embodiment, the interior of thecompartment220 is in the form of a conical shape (extending inward with distance from thebase212. This may enhance a snap-fit arrangement, press-fit arrangement or interference fit arrangement used to couplemodule750 to implant210. In an exemplary embodiment, the fit between the two components may be tightened with a screw arrangement or the like.

In some embodiments, themodule750 is dimensioned such that it fills all of thecompartment220, as may be seen inFIG. 7C, which depictsmodule750 fully inserted intocompartment220, formingassembly790. That is, themodule750 is dimensioned such that upon being fully seated on thebase212, all external surfaces of themodule750 are located at least flush with the top surface of theimplant210a.FIGS. 7A and 7B depict such exemplary embodiments. In alternate embodiments, themodule750 is dimensioned such that it fills only a portion ofcompartment220. In an exemplary embodiment, ifmodule750 is fully seated on thebase212, at least some external surfaces of themodule750 facing away from theskull136 are located below the top surface of theimplant210a. In some embodiments, theimplant210ais configured to leave a space between the bottom of themodule750 and thebase212.

In an exemplary embodiment, the overall height H3 of anexemplary assembly790 formed whenmodule750 is fully inserted intocompartment220 ofimplant210a, is about 6 mm, about 6.5 mm, about 7 mm, about 7.5 mm, about 8 mm, about 8.5 mm or about 9 mm or more or less, and/or may have a dimension falling between the just recited dimensions in any of about 0.1 mm increments. Of the overall height H3, about 2.5 mm, about 3.0 mm, about 3.5 mm, about 4.0 mm, about 4.5 mm, about 5.0 mm, about 5.5 mm or about 6 mm corresponds to H4, the height of the implant from the bottom of the implant to the bottom surface offlange216 or the bottom surface offixation arms230, with the remainder corresponding to the height from the bottom surface of theflange216 or the bottom surface offixation arms230 to the top ofmodule750. In some embodiments,assembly790 has a width W2 or width W3 of about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm or about 30 mm, or more or less, and/or may have a dimension falling between the just recited dimensions in any of about 0.1 mm increments. Width W2 is measured from the outer circumference offlange216, while width W3 is measured from the outer circumference ofsidewalls214.

Theimplant210ais configured to form a hermetic seal with themodule750. In an exemplary embodiment, theimplant210aincludes a seal, such as an o-ring seal, extending about the inner periphery of thecompartment220 that interfaces with themodule750 to prevent or at least effectively prevent the ingress of matter from outside theimplantable component150 formed by theimplant210aand themodule750 into any space between themodule750 and theimplant210a. In an alternative embodiment, theimplant210aincludes a surface configuration that interacts with a seal located about the outer periphery of themodule750 to form a hermetic seal at that location. Surfaces of theimplant210amay include a chamfer feature that improves the sealing capability of the implantable component. Alternatively or in addition to this, themodule750 may include a chamfer feature, and may be configured to mate with the chamfer of thereceiver housing210a. In an exemplary embodiment, at least a portion of theimplant210ahas a deformation zone located at, for example, the top interior circumference of theimplant210a(opposite the arms230) that creates a tighter hermetic seal between theimplant210aand the module relative to theimplant210anot having the deformation zone.

In an exemplary embodiment, an anti-microbial surface or chemical coating may be located on one or more or all of the mating surfaces of theimplant210aand/or themodule750.

In an alternate embodiment, implant210ais configured to removably receive a removable lid. In such an exemplary embodiment, an implantable component may be placed in thecompartment220 ofimplant210aand a lid may be placed over the opening ofcompartment220. Male threads may be included with the lid that interface withfemale threads217 ofimplant210a. Alternatively or in addition to this, theimplant210amay be configured to receive a mating portion of the lid at the top surface of thesidewall214 and/or flange216 (e.g., via a male portion having male or female threads that is received by a female portion of thesidewall214 had has, respectively, female or male threads, etc.) Theimplant210ais configured to form a hermetic seal at at least a portion of the interface of the removable lid and theimplant210a. In such an embodiment, the implantable component placed in thecompartment220 is shielded from the external environment of theimplant210avia the body of theimplant210aand the lid.

The removable lid can function as a protective cover for the implantable component placed in thecompartment220. Indeed, in some embodiments, the removable lid may also function as a protective cover for theimplant210a. In an exemplary embodiment, the removable lid may extend over the entire outer periphery of theimplant210aor at least the non-fixation arm periphery (the general periphery) of theimplant210a. The removable lid may have any dimension, size or shape that will permit embodiments to be practiced and variations thereof. As will be further detailed below, as with themodule750, the removable lid may have a dome shaped exterior that may provide enhanced resistance against external forces. In an exemplary embodiment, the domed shaped exterior is an epoxy-filled low-profile cover configured to divert substantially all (including all) impact forces to the circumference of the implant, as will be described in greater detail below.

Thus, the implantable component placed in thecompartment220 may not necessarily be hermetically sealed and/or may not necessarily be hardened to absorb the shock of an impact to the skin above theimplant210a(as will be discussed below) because of the hermetic seal between the lid and theimplant210aand because the lid may be hardened and/or configured to diffuse the shock of impact. In an exemplary embodiment, the lid andmodule750 are used together. Themodule750 may be fully seated in thecompartment220, thus permitting a sufficient amount offemale screw threads217 to be exposed such that male threads of the lid may also interface with thefemale threads217.

As mentioned above, in an exemplary embodiment, themodule750 or other components in thecompartment220 of theimplant210 may be accessed subsequent to implantation. In an exemplary embodiment, this may entail relatively minimal surgery. In an exemplary embodiment, this feature results from the fact that themodule750 and/or the removable lid are removable without removing theimplant210 from theskull136 and/or moving theimplant210 relative to theskull136. In an exemplary embodiment, a healthcare professional may repair, maintain and/or replace themodule750 and/or components in thecompartment220 without explanting theosseointegrated implant210. In some embodiments where theimplantable component150 is implanted in a bone adjacent to the skin, such access may be attained with minimal surgery.

An exemplary embodiment entailing the implantation of amodule750 into an exemplary implant will now be described in the context of removing a previously implantedmodule750 from the implant and either re-installing the previously implantedmodule750 or installing anew module750 in the implant. In an exemplary embodiment, themodule750 may be any module as detailed herein and variations thereof. In an exemplary embodiment, the implant may be any implant as detailed herein and variations thereof.

With reference to theprocedure800 represented in the flowchart ofFIG. 8, atstep810, a health care professional obtains access to animplantable component150. This may entail making an incision in the skin of the recipient to accessimplantable component150.Implantable component150 includes an implant according to an exemplary embodiment that has been implanted 5, 10, 15, 20 or more years previously. Amodule750 which has been in the recipient for 2, 5, 10, 15, 20 or more years is located in the compartment of the implant.

Atstep820, a healthcare professional removes themodule750 from the implanted implant and thus from the recipient.

Atstep830, which is an optional step, the recipient's head is subjected to an MRI procedure. Because themodule750 has been removed from the recipient, the size and/or quantity of artifacts in the resulting MRI images is reduced. Further, any deleterious effects of the MRI procedure that might be induced by the presence of themodule750 are reduced and/or eliminated due to the absence of themodule750. An exemplary embodiment includes a module that contains a magnetic material (e.g., permanent magnet).

Atstep840, upon a decision to reinstall the module removed from the recipient (such decision may or may not be part of the exemplary method800), that module is reinstalled into the implant implanted in the recipient. Such reinstallation may be executed by executing the actions executed in the removal procedure ofstep820 in reverse.

If a decision has been made to install a new module (such decision may or may not be part of the exemplary method800), a new module having previously been obtained (again, which may or may not be part of the exemplary method800),step840 is skipped and step850 is executed to install the new module into the implant implanted in the recipient. Such installation may be executed by executing the actions executed in the removal procedure ofstep820 in reverse.

It is noted that if the module is to be reinstalled,step850 may not be executed. It is further noted that in an embodiment, this permits controlled refitting of theimplantable device150 in that an upgradedimplantable device150 may be relatively easily obtained because the upgradable component is relatively easily removed from the recipient (e.g., because it is not osseointegrated to the skull). Moreover, some exemplary embodiments permit the new implant to be implanted at the exact same spot in the recipient, thus permitting an implant at the exact same location where the recipient became accustomed to having an implant. Further, no wait time is needed for osseointegration of the new component, as the interface between the new component and the skull remains the implant, which may be substantially fully osseointegrated to the skull.

As noted above, some embodiments of the implant include aflange216, such as that depicted inFIG. 2D with respect to implant210a. In an exemplary embodiment, theflange216 facilitates osseointegration of the implant to the skull. As may be seen inFIG. 2D, theflange216 extends from the perimeter of thesidewall214. Theflange216 may conform to the skull surface or lay on a more shallow recess of the skull, such as the portion of the recess depicted inFIG. 6. That is, theflange216 may rest on a portion of the skull where an additional recession is formed that conforms with the shape and diameter of theflange216 to improve the interface with the skull. The shape, dimensions or size of theflange216 may vary depending on the particular application for which theimplant210ais intended. An exemplary embodiment of theflange216 includes a planar bottom surface configured to rest against the skull. Theflange216 may be configured to rest on the hard cortical top layer of the skull when theimplant210ais secured within the recess. Theflange216 may be an extension of theimplant210aand may be made of the same material as some or all of the other components of the implant. In some embodiments, theimplant210ais a monolithic component including theflange216. In other embodiments, theflange216 is a separate component from that of the rest of theimplant210a. In an exemplary embodiment, theflange216 may be removably attached to the other portions of theimplant210a. Theflange216 may be formed such that it is relatively rigid while also being elastically and/or plastically malleable to conform to the corresponding portions of the skull to which/in which it is received. Theflange216 may be configured with varying thicknesses fordifferent implants210a.

As noted above, some embodiments of an implant includefixation arms230.Fixation arms230 may provide increased stability to theimplant210. Embodiments of an implant may include 1, 2, 3, 4, 5, 6 ormore fixation arms230. Note also that the fixation arms may not be uniform in design. As seen inFIGS. 2A-2D, thefixation arms230 extend from the outer perimeter ofsidewall214 and/or theflange216. As depicted inFIGS. 5A and 5B, the bottom portions of thefixation arms230 are configured to rest securely on theskull136.

Exemplary fixation arms

230 may have sufficient strength and stability to aid in securing theimplant210 within the recess of the skull. Thefixation arms230 may be secured to the skull surface (including surface of the portions of the recess formed to receive the fixation arms) by using bone screws, bone cement, etc. Any other fixation device, system or method may be used that will permit thefixation arms230 to be secured to the skull in order for at least some embodiments to be practiced in accordance with the teachings herein and variations thereof. With regard to embodiments utilizing bone screws, thefixation arms230 may have one or more pre-drilled openings orholes232 configured to receive a bone screw or some other fixation device that interfaces with theholes232. Thefixation arms230 may be a temporary fixation arm that is affixed to the outer perimeter of theflange216 and/or thesidewall214. In this regard, in an exemplary embodiment, thefixation arms230 may be removed upon certain events, such as osseointegration between the other portions of theimplant210 and the skull. Thus, in some embodiments, thefixation arms230 are removable/detachable. In an exemplary embodiment, the fixation arms may be bioabsorbable such that they dissolve (degrade) over time after implantation. Such an embodiment may utilize bone cement instead of screws to fix the fixation arms to the skull. It is noted that with respect to embodiments of the implant used with transctaneous bone conduction devices, described further below, the screws may not transmit effectively any (including any at all) vibrations to the skull.

In an exemplary embodiment, one or more of the fixation arms may have a rounded contact surface on the bottom-side of the fixation arm, as is depicted byfixation arm930 inFIG. 9. The roundedbottom contact surface934 may provide additional stable fixation and positioning of theimplant210. In an exemplary embodiment, the rounded bottom contact surfaces may be rounded “ball” contact surfaces. These surfaces may avoid rocking of the implant. The fixation arms may also be elastically and/or plastically deformable (upwards and/or downwards with respect to the longitudinal axis of the implant), and/or may have a slight upward orientation (away from the bottom of the implant).

In certain embodiments, designs ofimplants210 may be standardized to have the same exterior dimensions and/or exterior dimensions corresponding to a limited number of different designs. In an exemplary embodiment, this may facilitate the standardization of the medical procedures used to form the recesses in the skull and the medical procedures used to implant theimplants210 in the recesses. Such a standardized designs and surgical procedures decreases the size of any gaps (including eliminating any gaps) between the bone and the bone interface surfaces (or, more accurately, the intended bone interface surfaces) of theimplants210. In an exemplary embodiment, this limits the potential for a conductive route for microbials to enter and/or a space for microbials to multiply to a level resulting in an infection that warrants medical attention.

Themodule750 and/or compartment220 (sealed with the removable lid) includes functional components of theimplantable component150. In an exemplary embodiment, this includes active components. In an exemplary embodiment, this may also or alternatively include passive functional components. One or more functional components may be located in the module705 and/orcompartment220. The following exemplary embodiments are directed towards a hearing prosthesis in general, and a transcutaneous bone conduction device in particular. However, other embodiments includemodules750 and/or components contained incompartment220 used in other types of prostheses. An exemplary embodiment of theimplant210 may be used with any type of prostheses providing that the teachings detailed herein and variations thereof may be practiced.

With reference to a transcutaneous bone conduction device, exemplary active components include, for example, an implantable actuator of an active transcutaneous bone conduction device. Active components further include an RF coil, a battery, an accelerometer, a microphone and a sound processor. Exemplary passive components include, for example, the implantable portion of a passive transcutaneous bone conduction device that vibrates or otherwise moves in response to vibrations transmitted through the skin of the recipient. An exemplary embodiment that includes a vibratory element contained in the module and configured to vibrate in response to a sound signal. In such an exemplary embodiment, the vibratory element may be that of a passive transcutaneous bone conduction device and/or that of an active transcutaneous bone conduction device. As will be understood from the exemplary embodiments of a functional component, general structural components (e.g., screws, bolts, joining elements, fixtures, conduits, etc.) are not functional components. Functional components are components that react to outside input and perform a function in response to that outside input. For example, in the case of a passive transcutaneous bone conduction device in which a vibratory element is located in module750 (or in compartment220), that vibratory element receives vibrations from theexternal component140 and moves relative to skull to generate vibrations. In contrast, theimplant210 or a bone fixture, abutment and abutment screw of a percutaneous bone conduction device transmit vibrations from a vibratory element that moves, and thus they are structural, not functional, components.

With respect to a vibratory element contained inmodule750 and/orcompartment220, such asvibratory element1052 as depicted inFIG. 10 (represented in black-box format, the vibratory element may be a passive plate that moves relative to themodule750 and/orcompartment220 in response to vibration or an active vibrating actuator that vibrates in response to received electrical input, as detailed below), the vibratory element is ultimately disposed within theimplant210 such that vibration stimulation to the skull occurs without any substantial (including any) losses. In this regard, the vibratory element (or any other vibration generating device) may generate vibrations that are transmitted through theimplant210 and into the skull, which are in turn transmitted by the skull and ultimately to the cochlea to provide a hearing precept. Osseointegration of the implant with the skull may, in some embodiments, permit optimal vibration conduction to the hard skull layer.

The direction of movement of the vibrating element may be axial and/or radial relative to the implant, thereby generating vibrations in the axial and/or radial direction relative to the implant.

As may be seen from the figures, an exemplary embodiment includes an implant configured to receive a module and/or having a compartment such that at least a portion of the functional component, and in some instances, the entire the functional component, is located below an extrapolated outer profile of the skull136 (i.e., the profile of the skull that would be present if the recess had not been formed into the skull).

Referring back toFIG. 1, whereimplantable device150 corresponds to a fixation system using an implant as detailed herein and variations thereof and amodule750 inserted in thecompartment220 of the implant, in an exemplary embodiment of a passive transcutaneous bone conduction device, a vibrating actuator is located in theexternal component140. The vibrating actuator is located in housing of theexternal component140, and is coupled to a plate. The plate may be in the form of a permanent magnet and/or in another form that generates and/or is reactive to a magnetic field, or otherwise permits the establishment of magnetic attraction between theexternal device140 and theimplantable component150 sufficient to hold theexternal device140 against the skin of the recipient.

In an exemplary embodiment, the vibrating actuator of theexternal component140 is a device that converts electrical signals into vibration. In operation,sound input element126 converts sound into electrical signals. Specifically, the passive transcutaneous bone conduction device provides these electrical signals to the vibrating actuator, or to a sound processor that processes the electrical signals, and then provides those processed signals to the vibrating actuator of the external component. The vibrating actuator converts the electrical signals (processed or unprocessed) into vibrations. Because vibrating actuator of theexternal component140 is mechanically coupled to the plate of theexternal component140, the vibrations are transferred from the vibrating actuator to the plate.

Themodule750, which is part of theimplantable component150, includes an implanted plate1052 (also referred to herein as an implanted plate assembly, although for the purposes of describing this specific feature, the implantable plate assembly may comprise only one component, but it also may comprise more than one component) is made of a ferromagnetic material that may be in the form of a permanent magnet, that generates and/or is reactive to a magnetic field, or otherwise permits the establishment of a magnetic attraction between theexternal device140 and theimplantable component150 sufficient to hold theexternal device140 against the skin of the recipient. Accordingly, vibrations produced by the vibrating actuator of theexternal device140 are transferred from the plate of theexternal component140 across the skin toplate assembly1052. This may be accomplished as a result of mechanical conduction of the vibrations through the skin, resulting from theexternal device140 being in direct contact with the skin and/or from the magnetic field between the two plates. These vibrations are transferred without penetrating the skin with a solid object such as an abutment as detailed herein with respect to a percutaneous bone conduction device.

Themodule750 is substantially rigidly attached to the implant such that vibrations from theplate assembly1052 may be transmitted from themodule750 to the implant and thus into the skull with substantially no loss.

Referring back toFIG. 1, whereimplantable device150 corresponds to a fixation system using an implant as detailed herein and variations thereof and amodule750 inserted in thecompartment220 of the implant, in an exemplary embodiment of an active transcutaneous bone conduction device, vibratingelement1052 is a vibratingactuator1052 that is located in themodule750. Specifically, avibratory element1052 in the form of vibratingactuator1052 is located in a hermetically sealedhousing1060 of the module750 (or, in the case of the implant utilizing a lid, in the hermetically sealed compartment220).

It is noted that theenclosure1060 and/or thecompartment220 may also be hermetically sealed in the case where the vibratory element is a plate assembly as detailed above with respect to the passive transcutaneous bone conduction device.

In an exemplary embodiment, much like the vibrating actuator of theexternal device140 described above with respect to the passive transcutaneous bone conduction device, the vibrating actuator of theimplantable device150 is a device that converts electrical signals into vibration.

External component

140 may include asound input element126 that converts sound into electrical signals. Specifically, the active transcutaneous bone conduction device provides these electrical signals to the implanted vibratingactuator1052, or to a sound processor (not shown) that processes the electrical signals, and then provides those processed signals to theimplantable component150 through the skin of the recipient via a magnetic inductance link. In this regard, a transmitter coil of theexternal component140 transmits these signals to an implanted receiver coil located in themodule750 orcompartment220 or in another module or compartment associated with a separate implant (discussed in greater detail below) of theimplantable component150. Components in themodule750/compartment220 (or other components of a separate implant), such as, for example, a signal generator or an implanted sound processor, then generate electrical signals to be delivered to vibratingactuator1052 via electrical lead assembly. The vibratingactuator1052 converts the electrical signals into vibrations.

The vibratingactuator1052 may be mechanically coupled to themodule750 and/or thecompartment220. Themodule750 substantially rigidly attached to the implant such that vibrations from the vibratingactuator1052 may be transmitted from themodule750 to the implant and thus into the skull with substantially no loss.

The above embodiments have been described in terms of a implant into which a functional component may be relatively easily removed and installed without removing the implant from the skull. An exemplary embodiment as will now be detailed includes animplantable component150 that utilizes embodiments of the implant detailed above and variations thereof as part of an implant that forms a permanent enclosure (as distinguished from the enclosure formed by, for example, the lid in combination with the implant detailed above).

By “permanent,” it is meant that the structural integrity of the implant must be substantially structurally degraded to access the interior of the enclosure. In some embodiments, the permanent enclosure forms a hermetic environment vis-à-vis the external environment of the implant. In other embodiments, the enclosure does not form a hermetic environment.

FIG. 11 depicts anexemplary implant1110 according to such an embodiment, whereimplant210 is mated withhood1175 in a permanent manner (e.g., thehood1175 is welded to implant210 viaweld1180—this weld would need to be fractured or the material proximate the weld would need to be removed to remove thehood1175 from the implant210). Theimplant1110 forms anenclosure1120 in which afunctional component1052 is located, which may correspond to any of the functional components detailed herein and variations thereof, including a vibratory element. In an exemplary embodiment,implant1110 includes the features and/or functionality of any of the embodiments of the implants, alone and/or in combination with a lid and/or module as detailed herein and variations thereof except that the enclosure (which may be considered to correspond to thecompartment220 for the purposes of this immediate discussion) is a permanent enclosure that permanently encloses thefunctional component1052. Additional features of an implant will now be described. It is noted that unless otherwise specified, the features and/or functionality of any of the embodiments of the implants described herein and variations thereof are also present in the embodiments of the implants, alone or in combination with a lid and/or module as detailed herein and variations thereof.

In an exemplary embodiment, as may be seen inFIG. 11, theimplant1110 includes ahood1175 that includes a domed portion that constantly curves along its span. With reference toFIG. 12 and hood1275 (described further below), the outer surface of the dome may have a substantially constant radius, and thus may be in the form of a full or partial hemisphere.FIG. 12 depicts anarched hood1275 in the form of a dome extending from a region proximate to the periphery of theimplant1210. Other convex (with respect to the enclosure1120) shaped components may be used for thehood1175. By way of example, partial dome may be used, where, for example, the hood arches for about ¼^ththe distance from its outer circumference, and then levels off to a flat surface for the remaining expanse across theenclosure1120. Any geometric configuration of the hood may be used in some embodiments providing that embodiments as described herein and variations thereof may be practiced. In some embodiments, the

hoods

1175 and1275 and/or variations thereof may be used with some or no modification as lids for the implants detailed herein. Indeed, in an exemplary embodiment,

hoods

1175 and1275 are configured with male threads at the locations where the base of the hoods would interface with the implants. In an exemplary embodiment, the domed structure is reinforced with additional structure on the inside of the hoods, thus making a composite dome. Still further, the exterior of the hood may be in the form of a dome, while the interior of the hood may be substantially flat.

In an exemplary embodiment, the overall height H1 of an exemplary implant, such asimplant1120, is about 5 mm to about 6 mm (e.g., 5.5 mm, 6 mm, about 3.5 mm to about 7 mm, 2.5 mm, etc.). In an embodiment, the implants are configured to be inserted in a recess in the skull that extends top a depth of about 1 mm into the skull such that the implant extends about 0.5 to 1 mm into the skull, as may be seen inFIG. 12 with respect to Dl. Accordingly, an exemplary embodiment may extend about 4.5 to about 5.5 mm above the surface of the skull, as may be seen inFIG. 12 with respect to H2. In some embodiments, the implant has a width (e.g., base diameter) of about 30 mm, as may be seen inFIG. 11 with respect to W1. The base portions of the implants ofFIGS. 11 and 12 are depicted as having flat bases. However, bases such as the base used inFIG. 4 may be used. Along these lines, in an exemplary embodiment, the implants are configured to be inserted in a recess in the skull that extends to a depth of about 0.5 to 1 mm into the skull at the periphery of the recess and extends about 2 mm at about the center of the recess such that the implant extends about 0.5 to about 1 mm, about 3 to about 7 mm (or any range or specific value therein in 0.5 mm increments (e.g., it may extend to the dura of the skull)) into the skull at the periphery and about 2 mm at the center of the implant. In an exemplary embodiment, recesses extending 0.5 to 1 mm into the skull and/or about 2 mm into the skull may be used in pediatric subcutaneous applications. In an exemplary embodiment, the thickness of the hood is about 0.5 to about 1.0 mm (e.g., 0.8 mm). In an exemplary embodiment, with reference toFIG. 11, theimplant1110 includes a base1112 located in a recess formed in a recipient's skull, thebase1112 having a diameter (W1) on a plane parallel to a bottom of the recess and/or parallel to the bottom of the base1112 that is at least about twice, about three times, about four times and/or about five times the height H1 of theimplant1110 in a direction normal to the plane.

Alternatively or in addition to the exemplary embodiment(s) described in the preceding paragraph, the implantable medical device may include at least a partially arched hood covering the permanent enclosure configured to direct an impact load originating externally from the implantable medical device to a region at least proximate to a periphery of the implantable medical device. In such an exemplary embodiment, the at least partially arched hood may be a dome extending from a region at and/or proximate to the periphery of the implantable medical device.

As will be appreciated from a comparison betweenFIGS. 11 and 12,implant1275 utilizes an implant that has sidewalls that are not as high as those of, for example,210. Particularly,implant210bofFIG. 12 is configured with sidewalls having a height of 1-2 mm. Accordingly,hood1275 forms a substantial portion of theenclosure1220. In an exemplary embodiment, the hoods detailed herein and variations thereof protect the functional components contained in the enclosure of the implant from some types of impact originating external to the recipient. Further, the hoods detailed herein and variations thereof, in some embodiments, are configured to reduce the risk of damage to the skin as a result of an impact originating external to the recipient. More particularly, some embodiments of the implant will be placed at a location on the body (e.g., skull) where there is relatively little distance between the apex of the hood and the surface of the skin (e.g., relatively little fat, muscle and a thin skin area). Moreover, some embodiments of the implant may be placed at a location on the body (e.g., skull) that is not shielded by other portions of the body. Thus, the implant may experience relatively high-load impacts during its implantation lifetime.

In view of the above, by placing the implant in a recess within the skull, it has a lower profile than if it were placed on the surface of the skull without a recess therein. Thus, the implant may have a height that is larger than one that is placed on the surface of the skull (because the recess in the skull absorbs some of that height). In an exemplary embodiment, this extra height permits the hood to extend from the periphery at a greater angle than it might otherwise extend and/or be thicker than it otherwise might be, thus permitting a geometry of the implantable hosing that better distributes the shock from an impact to the hood (and reducing the likelihood that the hood will collapse and/or the integrity of any hermetic environment of the enclosure is not lost). In an exemplary embodiment, the implant includes at least a partially arched hood covering the permanent enclosure configured to direct an impact load originating external from the implant to a region at and/or proximate to a periphery of the implant, such as, with respect to the embodiment ofFIG. 11, the interior of the sidewall(s)1114 and/or the outer periphery of theenclosure1120 and/or the outer periphery of the base within theenclosure1120 of the implant.

Alternatively or in addition to this, because of the lower profile, the implantable component does not extend above the surface of the skull to a height that it otherwise might extend, if at all, thus permitting the overall profile of the implant to be lower. In some exemplary embodiments, the geometries of the implant are such that the pinch hazard is reduced. That is, an exemplary embodiment includes a smooth and contoured hood extending to a maximum height above the skull such that it more evenly distributes pressure subjected to the skin from an impact. Put another way, the implant has a geometry that provides a reduced pinch hazard, thus limiting damage to soft tissue and recipient discomfort.

In an exemplary embodiment, the implant is configured with a geometry such that an impact force delivered to the hood is distributed to the periphery of the implant, and thus to the sidewalls and into the base of the implant, which rests flat or substantially flat in the surface of the recess of the skull. In an exemplary embodiment of this embodiment, the implant is thus more shock resistant than if the impact force was distributed to other portions of the implantable component.

In an exemplary embodiment, all or effectively all of the components of the implant are configured such that there are no “free hanging” housing ends. In this regard, the fixation arms may lie flat on bone surface (on the skull surface or recess surface). Such a configuration reduces (including eliminates) additional implant resonance frequencies in the audio spectrum which may deleteriously affect the audio performance of a transcutaneous bone conduction device.

In an exemplary embodiment, the implant has no joints or mating components on the exterior surface that are not fused together (e.g., via welding, sintering, etc.). Hereinafter, such an embodiment is referred to as a monolithic implant. However, in an alternate embodiment, there is an implant that has no joints or mating components on the exterior surface that are not fused together with the exception of an electrical lead port (discussed further below). Hereinafter, such an embodiment is referred to as a monolithic implant with electrical lead ports. In such an exemplary embodiment, the risk of infection by microbes may be reduced as compared to an implant with joints or mating components on the exterior surface that are not fused together. In an exemplary embodiment, the monolithic implant and/or the substantially monolithic implant has a relatively high reliability because there are no parts of the implant which may become loose over time.

In an exemplary embodiment, all functional components of theimplantable component150 are located in a single implant. In an alternate embodiment, all functional components except for a telecoil and/or a rechargeable battery are located in a single implant, and the telecoil and/or battery is located in a separate implant. In the same vein, in an exemplary embodiment, all functional components of theimplantable component150 are located in a single module located in a single implant. In an alternate embodiment, all functional components except for a telecoil and/or a rechargeable battery are located in a single module received in a single implant, and the telecoil and/or battery is located in a separate module received in a separate implant. Respective lead assemblies etc. the two implants and modules.

FIG. 13 depicts animplantable component150 in the form of an active transcutaneous bone conduction device.Implantable component150 comprising twoimplants210aand twomodules750 respectively received therein, respectively formingassembly1310 andassembly1320. The implants are received in theskull136 as detailed herein. Eachimplant210aincludes threebone screws1310 that extend through respective fixation arms and into theskull136 as detailed herein.Assembly1310 includes a vibrating actuator and a control unit. The vibrating actuator vibrates, and those vibrations are transmitted from themodule750 in which it is located to theimplant210athat receives that module and then to theskull136 as detailed herein so as to provide vibrations to the cochlea (not shown) to impart a hearing precept.Assembly1320 includes an RF telecoil and a rechargeable battery. The RF telecoil receives a transcutaneous RF signal and outputs an electrical signal to theassembly1310 vialead assembly1330 that extends between

assemblies

1310 and1320.

Lead assembly

1330 enters therespective modules750 via lead port780 (with reference toFIG. 10). Leadport760 provides a shielded inlet for the lead assemblies and prevents the lead assembly from being pinched between portions of theimplantable component150. As may be seen, it is located on the top of themodule750. Leadport760 may include a feedthrough that is hermetically sealed in themodule750. Thus, instead of entering themodule750, the lead assembly is connected to the feedthrough and the electrical signals are transferred from the lead assembly to the feedthrough and thus into themodule750 through the feedthrough.

In an exemplary embodiment, thelead port760 is configured such that the lead enters the lead port at a location that permits the lead to remain on the skull until it reaches theassembly1310 and/or1320. In an alternate embodiment, theimplant210aand/or themodule750 is configured such that the lead may extend from the respective assembly below the surface of the skull. In an exemplary embodiment, a groove or the like is formed in the skull such that the lead assembly travels at least partially below the surface of the skull. This groove may extend from oneassembly1310 to theother assembly1320, or may only partially extend from the respective assembly, thus providing a gradual transition from below the surface of the skull to above the surface of the skull. However, in an alternate embodiment, there is no lead assembly used in theimplantable component150. Instead, the

assemblies

1310 and1320 wirelessly communicate between one another.

In an exemplary embodiment, implant210amay include a slit and/or a tube shaped or half-tube shaped opening at, for example, the top portion of theimplant210athrough which a lead wire may exit thecompartment220.

An exemplary embodiment includes devices, systems and/or methods of forming the recesses in the skull or bones as disclosed herein and variations thereof. Still further, an exemplary embodiment includes the combination of any device disclosed herein and variations thereof with the recesses in the skull or bones as disclosed herein and variations thereof.

An exemplary embodiment utilizing two or more implants permits the functional components to be distributed across multiple implants thereby reducing the size of individual implants.

While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents. All patents and publications discussed herein are incorporated in their entirety by reference thereto.

Claims

What is claimed is:

1. An implant comprising:

a compartment, wherein the implant is configured for secured implantation into a recess formed in a recipient's bone, and wherein the compartment is configured to removably retain a separate component such that the separate component is removable from the compartment without removing the implant from the bone.

2. The implant ofclaim 1, wherein the separate component is a module of an implantable medical device.

3. The implant ofclaim 2, wherein the module is a functional component of the implantable medical device.

4. The implant ofclaim 1, wherein:

the separate component is a lid configured to cover the compartment.

5. The implant ofclaim 3, wherein:

the functional component is an active component of the implantable medical device.

6. The implant ofclaim 3, wherein:

the functional component is a passive component of the implantable medical device.

7. The implant ofclaim 5, wherein:

the implantable medical device is an active transcutaneous bone conduction device, and wherein the active component is a vibrating actuator of the transcutaneous bone conduction device.

8. The implant ofclaim 6, wherein:

the implantable medical device is a passive transcutaneous bone conduction device, and wherein the passive component is an implantable component configured to vibrate in response to vibrations transcutaneously transmitted to the compartment.

9. The implant ofclaim 1, wherein:

the implant includes a base and at least one sidewall extending from the base, the base and the sidewall forming the compartment, the implant having an aperture wherein the implant is configured such that while implanted in the bone the compartment is accessible via the aperture; and

the compartment is configured to removably retainably receive the separate implantable component through the aperture.

10. The implant ofclaim 1, wherein:

the implant is configured to form a hermetic seal between the separate component and the implant upon attachment of the separate component to the implant after the implant is secured to the bone, thereby hermetically sealing the compartment from an external environment of the implantable assembly while the implant is secured to the bone.

11. The implant ofclaim 4, wherein:

the implant is configured to removably retain a second separate component in the container while the implant is secured to the bone and while the lid is not attached to the implant; and

the lid covers the second separate component when the lid is attached to the implant.

12. The implant ofclaim 11, wherein:

the implant configured to hermetically isolate the second separate component from the external environment of the implant after the lid is attached to the implant after the second separate component is removably retained in the container.

13. The implant ofclaim 1, wherein:

the implant includes a bone interface surface configured to osseointegrate with the bone after implantation into the recess.

14. The implant ofclaim 1, wherein:

the implant includes a flange extending about the implant and forming an outer perimeter of the implant; and

the flange is configured to osseointegrate with the bone after implantation into the recess.

15. The implant ofclaim 1, further comprising:

at least one fixation arm that extends away from a general outer perimeter of the implant, wherein the fixation arm includes a hole configured to receive a bone fixation screw to screw the fixation arm to the bone.

16. The implant ofclaim 3, wherein:

the implant includes a fixation mechanism in the compartment that permits the module to be removably retained in the compartment while the implant is secured to the bone.

17. An implantable component, comprising:

a compartment; and

a vibratory element of a transcutaneous bone conduction device positioned in the compartment, wherein the implantable component is configured to be totally subcutaneously implanted in a recess formed in the recipient's bone.

18. The implantable component ofclaim 17, wherein:

the implantable component includes a base configured to be located in the recess, the base having a diameter on a plane parallel to a bottom of the recess that is at least about twice a height of the implantable component in a direction normal to the plane.

19. The implantable component ofclaim 18, wherein:

the base has a diameter on the plane that is at least about four times the height of the implantable component.

20. The implantable component ofclaim 18, wherein:

the implantable component is configured to transmit vibrations from the vibratory element to the implantable component and from at least portions of the implantable component implanted in the skull to the skull.

21. The implantable component ofclaim 18, wherein:

the vibratory element is positioned substantially entirely in the compartment.

22. A medical procedure, comprising:

obtaining access to an implant totally subcutaneously implanted in a recipient, wherein at least a portion of at least a first component of the implant is located in a recess in bone and is osseointegrated to the bone;

while the at least first component is located in the recess and is osseointegrated to the bone, detaching a second component from the first component;

while the at least first component is located in the recess and is osseointegrated to the bone, removing the second component from within the recipient while the at least first component is located in the recess and is osseointegrated to the bone; and

while the at least first component is located in the recess and is osseointegrated to the bone, reattaching the second component or attaching a third component to the first component such that the second component or the third component is subcutaneously implanted in the recipient.

23. The medical procedure ofclaim 22, wherein:

the first component is housing;

the second component includes a functional component of the implant; and

the third component includes a functional component that provides substantially the same functionality as that of the second component.

24. The medical procedure ofclaim 22, wherein:

the implanted assembly is implanted in a skull of the recipient; and

the medical procedure further comprising:

while the at least first component is located in the recess and is osseointegrated to the bone, performing an MRI of the head of the recipient after the second component has been removed from within the recipient and prior to reattaching the second component or the third component to the first component.

25. The implant ofclaim 9, wherein:

the base is substantially flat, and wherein the sidewall extends orthogonally from the base.

26. The implant ofclaim 1, further comprising:

the separate component, wherein

an overall height of the implant and the separate component, when the separate component is fully retained in the compartment, in a direction parallel to a longitudinal axis of the implant is about 7 to about 8 mm, and

an outer diameter of the implant on a plane normal to the longitudinal axis is about 25 to about 27 mm.

27. An implantable device, comprising:

a component configured to be removably retained in a compartment of an implant such that the component is removable from the compartment without moving the implant relative to an organ of a recipient proximate the implant.

28. The implantable device ofclaim 27, wherein:

the organ is bone;

the implant is securely implanted in a recess formed in the bone; and

the component is removable from the compartment without removing the implant from the bone.

29. The implantable device ofclaim 27, wherein:

the component is a module containing a functional component of an implantable medical device.

30. The implantable device ofclaim 27, wherein:

the component includes a fixation mechanism configured to interact with a corresponding fixation mechanism of the implant to enable the component to be removably retained in the compartment.

31. The implantable device ofclaim 30, wherein:

the fixation mechanism of the component includes male screw threads; and

the fixation mechanism of the implant includes female screw threads that interface with the male screw threads of the component.

32. The implant ofclaim 1, further comprising:

a flexible diaphragm forming part or all of a base of the implant.