The present application relates generally to implantable auditory prostheses, and more specifically systems and methods using magnetic force to transcutaneously mechanically couple an external portion of an auditory prosthesis with an implanted portion of the auditory prosthesis.
Hearing loss, which may be due to many different causes, is generally of two types, conductive and/or sensorineural. Conductive hearing loss occurs when the normal mechanical pathways of the outer and/or middle ear are impeded, for example, by damage to the ossicular chain or ear canal. Sensorineural hearing loss occurs when there is damage to the inner ear, or to the nerve pathways from the inner ear to the brain. Auditory prostheses of various types are widely used to improve the lives of users. Such devices include, for example, hearing aids, cochlear implants, bone conduction implants, middle ear implants, and electro-acoustic devices.
Individuals who suffer from conductive hearing loss typically have some form of residual hearing because the hair cells in the cochlea are undamaged. As a result, individuals suffering from conductive hearing loss might receive an auditory prosthesis that generates mechanical motion of the cochlea fluid instead of a hearing aid based on the type of conductive loss, amount of hearing loss and customer preference. Such prostheses include, for example, bone conduction devices and direct acoustic stimulators.
In many people who are profoundly deaf, however, the reason for their deafness is sensorineural hearing loss. Those suffering from some forms of sensorineural hearing loss are unable to derive suitable benefit from auditory prostheses that generate mechanical motion of the cochlea fluid. Such individuals can benefit from implantable auditory prostheses that stimulate nerve cells of the recipient's auditory system in other ways (e.g., electrical, optical, and the like). Cochlear implants are often proposed when the sensorineural hearing loss is due to the absence or destruction of the cochlea hair cells, which transduce acoustic signals into nerve impulses. Auditory brainstem stimulators might also be proposed when a recipient experiences sensorineural hearing loss due to damage to the auditory nerve.
In one aspect disclosed herein, an apparatus is provided which comprises a cavity and a ferromagnet assembly having a first centroidal axis. The ferromagnet assembly is configured to be contained within the cavity. The ferromagnet assembly comprises a first portion comprising at least one non-ferromagnetic material. The ferromagnet assembly further comprises a second portion comprising at least one ferromagnetic material, the second portion having a second centroidal axis that is offset from the first centroidal axis.
In another aspect disclosed herein, an apparatus is provided which comprises a housing configured to be placed over a portion of skin of a recipient, the portion of skin overlaying an implanted device. The implanted device comprises an internal inductive communication coil and an internal ferromagnetic material. The apparatus further comprises an external inductive communication coil within the housing. The external inductive communication coil is configured to be in inductive communication with the internal inductive communication coil. The apparatus further comprises an external ferromagnet contained within a cavity of the housing and substantially filling the cavity. The external ferromagnet comprises a ferromagnetic portion and a non-ferromagnetic portion. The ferromagnetic portion is configured to be magnetically attracted to the internal ferromagnetic material. The cavity has a center that defines a line with a center of the external inductive communication coil and the ferromagnetic portion has a center that is offset from the line.
In still another aspect disclosed herein a method is provided which comprises providing a sound processor assembly of an auditory prosthesis. The assembly is configured to be placed over a portion of skin of a recipient overlaying an implanted portion of the auditory prosthesis. The sound processor assembly comprises at least one external inductive communication coil configured to be in inductive communication with at least one internal inductive communication coil of the implanted portion of the auditory prosthesis. The sound processor assembly further comprises a cavity configured to contain a ferromagnet assembly. The method further comprises, in response to a thickness of the portion of skin, selecting a ferromagnet assembly from two or more ferromagnet assemblies configured to be contained within the cavity. Each of the two or more ferromagnet assemblies is configured to, upon being contained within the cavity and the sound processor assembly being placed over the portion of skin, displace the at least one external inductive communication coil relative to the at least one internal inductive communication coil by a corresponding offset in a direction parallel to the portion of skin while providing sufficient magnetic force to retain the sound processor assembly over the portion of skin.
Embodiments are described herein in conjunction with the accompanying drawings, in which:
Certain embodiments described herein advantageously provide a variable offset, in a direction parallel to the recipient's skin, between the external coil of an external component of an auditory prosthesis and the implanted coil for transcutaneous communication. The amount of offset can be easily adjusted, in response at least in part to the recipient's skin flap thickness, by selecting and using a ferromagnet assembly that fits within the external component and that has a ferromagnetic portion that is offset from a center of the ferromagnet assembly. This offset and the concomitant reduction of the coupling coefficient k between the external and implanted coils, is achieved without any change to existing designs of the external component, the retention force provided by the ferromagnet assembly or the implant magnet.
The teachings detailed herein are applicable, in at least some embodiments, to any type of auditory prosthesis utilizing an implantable actuator 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. Embodiments can include any type of auditory prosthesis that can utilize the teachings detailed herein and/or variations thereof. In some embodiments, the teachings detailed herein and/or variations thereof can be utilized in other types of prostheses beyond auditory prostheses. For example, the concepts described herein can be applied to any of a variety of implantable medical devices that utilize the transfer of power and/or data between an implanted component and an external component via inductive coupling (e.g., pacemakers; implantable EEG monitoring devices; visual prostheses).
As shown in
As shown in
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.
The internal component 144 comprises an internal receiver unit 132, a stimulator unit 120, and an elongate electrode assembly 118. In some embodiments, the internal receiver unit 132 and the stimulator unit 120 are hermetically sealed within a biocompatible housing. The internal receiver unit 132 comprises at least one second inductive communication coil 136 (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 (also not shown) fixed relative to the at least one second inductive communication 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 at least one second inductive communication coil 136 receives power and/or data signals from the at least one first inductive communication coil 130 via a transcutaneous energy transfer link (e.g., an inductive RF link). The stimulator unit 120 generates electrical stimulation signals based on the data signals, and the stimulation signals are delivered to the recipient via the elongate electrode assembly 118.
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 embodiments, 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.
The elongate electrode assembly 118 comprises a longitudinally aligned and distally extending array 146 of electrodes or contacts 148, sometimes referred to as electrode or contact array 146 herein, disposed along a length thereof. Although the electrode array 146 can be disposed on the electrode assembly 118, in most practical applications, the electrode array 146 is integrated into the electrode assembly 118 (e.g., the electrode array 146 is disposed in the electrode assembly 118). As noted, the stimulator unit 120 generates stimulation signals which are applied by the electrodes 148 to the cochlea 140, thereby stimulating the auditory nerve 114.
The transmitter unit 128 comprises at least one first inductive communication coil 130 (e.g., a planar inductor coil having a plurality of turns) external to the recipient and the implanted receiver unit 132 comprises at least one second inductive communication coil 136 (e.g., a planar inductor coil having a plurality of turns) which form an transcutaneous inductive radio frequency (RF) communication link between the external component 142 and the internal component 144, across which the internal component 144 receives power and/or data signals from the external component 142. These inductive communication coils 130, 136 interact with one another via magnetic flux of one of the inductive communication coils 130, 136 passing through the other one of the inductive communication coils 130, 136. This interaction between the at least one first inductive communication coil 130 and the at least one second inductive communication coil 136 can be characterized by a coupling coefficient k (e.g., with 0≤k≤1), which can be understood to relate to (e.g., can be defined as) the fraction of magnetic flux produced by one of the coils 130, 136 that couples to the other of the coils 130, 136. The value of the coupling coefficient k is dependent on the geometries of the coils 130, 136, their relative distance from one another, and the offset between their axes 160, 162.
As schematically illustrated in
As illustrated by
In addition to differences of SFT among different recipients, the SFT can also change under various physiological situations (e.g., weight loss or gain by recipient; growth of the recipient). These changes of SFT present a challenge in tuning the RF communication link between the external component 142 and the internal component 144 for recipients having small values of SFT, since such changes of the SFT can result in large changes of the coupling coefficient k. For example, looking at the “Offset=0” curve of
Rather than utilizing the largest possible coupling coefficient k for any given SFT (e.g., to maximize the power transfer efficiency between the external component 142 and the internal component 144), certain embodiments instead reduce the maximum value of the coupling coefficient k (e.g., to improve data integrity and/or RF link strength consistency) for a recipient having a small SFT value. In certain embodiments, a non-zero offset is introduced between the center axes of the inductive communication coils 130, 136. For example, looking at the “Offset=5 mm” curve of
In certain embodiments, the introduction of an offset advantageously improves the overall efficiency of the RF communication link (e.g., by making the RF communication link easier to tune and/or making the strength of the RF link more consistent), improves data integrity, reduces fitting issues for clinicians, and/or gives recipients longer battery life. Furthermore, certain embodiments advantageously utilize the space within the cavity 210 in a beneficial way to improve the RF communication link. The offset can be introduced without modifications of the housing 150 or other portion of the external component 142 and/or the housing 154 or other portion of the internal component 144, thereby allowing certain embodiments described herein to be retrofitted with existing products to assist with tuning issues and/or to improve overall efficiency.
In certain embodiments, the apparatus 200 is a component of an auditory prosthesis system, examples of which include but are not limited to: a cochlear implant system, a bone conduction implant system (e.g., active bone conduction system; passive bone conduction system, percutaneous bone conduction system; transcutaneous bone conduction system), a Direct Acoustic Cochlear Implant (DACI) system, a middle ear implant system, a middle ear transducer (MET) system, an electro-acoustic implant system, another type of auditory prosthesis system, and/or combinations or variations thereof.
In certain embodiments, the cavity 210 has a third centroidal axis 212 and is within the external component 142 of the auditory prosthesis system. In certain embodiments, the cavity 210 has a cylindrical shape with a cross-section (e.g., circular; elliptical; square; rectangular; polygonal; geometric; irregular; symmetric; non-symmetric) with straight, curved, or irregular sides in a plane perpendicular to a longitudinal axis of the cavity 210 and having a perimeter in the plane perpendicular to the longitudinal axis. For example, as schematically illustrated in
While
In certain embodiments, the ferromagnet assembly 220 is configured to be contained within the cavity 210 such that the first centroidal axis 222 is coincident with the third centroidal axis 212. In certain embodiments, the ferromagnet assembly 220 has a cylindrical shape with a cross-section (e.g., circular; elliptical; square; rectangular; polygonal; geometric; irregular; symmetric; non-symmetric) with straight, curved, or irregular sides in a plane perpendicular to a longitudinal axis of the ferromagnet assembly 220 and having a perimeter in the plane perpendicular to the longitudinal axis. For example, as schematically illustrated in
In certain embodiments, the at least one non-ferromagnetic material of the first portion 230 of the ferromagnet assembly 220 comprises at least one of: plastic, epoxy, ceramic, titanium, aluminum, and a non-ferromagnetic metal. In certain embodiments, the at least one ferromagnetic material of the second portion 240 of the ferromagnet assembly 220 comprises at least one of: iron, nickel, cobalt, and steel. The second portion 240 of certain embodiments comprises a permanent magnet having an external static magnetic field, while in certain other embodiments, the second portion 240 does not comprise a permanent magnet but is configured to be magnetically attracted to a ferromagnet portion of a magnet beneath the skin of the recipient. Thus, in certain embodiment, the ferromagnet assembly 220 does not comprise a magnet, but does comprise a ferromagnetic material. The ferromagnet assembly 220 of certain embodiments is a unitary member such that the first portion 230 and the second portion 240 cannot be easily separated from one another without damaging the ferromagnet assembly 220, while in certain other embodiments, the first portion 230 and the second portion 240 are configured to be reversibly and repeatedly separated from and rejoined to one another without damaging the ferromagnet assembly 220.
While
In certain embodiments, the second portion 240 has a cylindrical shape with a cross-section (e.g., circular; square; rectangular; polygonal; geometric; irregular; symmetric; non-symmetric) with straight, curved, or irregular sides in a plane perpendicular to a longitudinal axis of the second portion 240 and having a perimeter in the plane perpendicular to the longitudinal axis. For example, as schematically illustrated in
As schematically illustrated by
In certain embodiments, as schematically illustrated by
In certain embodiments, the internal ferromagnetic portion 156 and the second portion 240 of the ferromagnet assembly 220 are configured to be magnetically attracted to one another (e.g., one or both of the internal ferromagnetic portion 156 and the second portion 240 comprising a magnet having a static magnetic field) with the skin tissue 158 of the recipient therebetween. In certain embodiments, the implanted second ferromagnetic portion 156 is encircled by the at least one second inductive communication coil 136 and the ferromagnet assembly 220 (including the second portion 240) is encircled by the at least one first inductive communication coil 130. In addition, as schematically illustrated by
In certain embodiments, the ferromagnet assembly 220 can be selected based, at least in part on the skin flap thickness, to provide a predetermined offset d between the at least one first inductive communication coil 130 of the external component 142 and the at least one second inductive communication coil 136 of the implanted component 144. For example, as schematically illustrated by
As schematically illustrated by
The examples of
In certain embodiments, in addition to having the position of the second portion 240 within the cavity 210 selected, based on a thickness of the portion of skin 158, to produce a predetermined offset d between the at least one first inductive communication coil 130 and the at least one second inductive communication coil 136, the size of the second portion 240 of the ferromagnet assembly 220 is selected to provide a predetermined amount of magnetic attraction between the external component 142 and the internal component 144 (e.g., a sufficient amount of magnetic attraction to maintain the position of the external component 142 on the recipient). The second portion 240 of certain embodiments has one or more lateral dimensions (e.g., in a direction parallel to the skin 158) that are smaller than corresponding lateral dimensions of the implanted ferromagnetic portion 156. For example, the implanted ferromagnetic portion 156 can have a first perimeter P1 in a plane parallel to the portion of skin 158 and the second portion 240 can have a second perimeter P2 in a plane parallel to the portion of skin 158 (e.g., the third circumference C3 in the plane perpendicular to the second centroidal axis 242) that is smaller than the first perimeter P1. In certain embodiments the first perimeter P1 is in a range of 60 millimeters to 72 millimeters, and the second perimeter P2 (e.g., third circumference C3) is in a range of 6 millimeters to 70 millimeters. In certain embodiments, the perimeter (e.g., outer circumference) of the at least one first inductive communication coil 130 is in a range of 60 millimeters to 110 millimeters and the perimeter (e.g., outer circumference) of the at least one second inductive communication coil 136 is in a range of 60 millimeters to 110 millimeters. In addition, in certain embodiments, a direction of the offset can be selected (e.g., using a cavity 210 and ferromagnet assembly 220 that are “keyed” by a non-symmetric feature to have the offset occur in a predetermined lateral direction. For example, the second portion 240 can be positioned closer to a region of the external component 142 expected to experience larger forces that may inadvertently remove or displace the external component 142 relative to the recipient during operation (e.g., a region near wires or leads connected to the external component 142).
In an operational block 320, the method 300 further comprises, in response to a thickness of the portion of skin 158, selecting a ferromagnet assembly 200 from two or more ferromagnet assemblies 220 configured to be contained within the cavity 210. Each of the two or more ferromagnet assemblies 220 is configured to, upon being contained within the cavity 210 and the sound processor assembly being placed over the portion of skin 158, displace the at least one external inductive communication coil relative to the at least one internal inductive communication coil by a corresponding offset in a direction parallel to the portion of skin 158 while providing sufficient magnetic force to retain the sound processor assembly over the portion of skin 158.
In certain embodiments, each of the two or more ferromagnet assemblies 220 has a corresponding ferromagnetic portion (e.g., second portion 240; a ferromagnet; a non-magnetic ferromagnetic portion) and a corresponding non-magnetic portion (e.g., first portion 230), with the ferromagnetic portion having a corresponding offset relative to a center of the at least one external inductive communication coil. In certain embodiments, the method 300 further comprises inserting the selected ferromagnet assembly 220 into the cavity 210. For example, a clinician can evaluate the skin flap thickness of the recipient, can select (e.g., prescribe), based at least in part on the skin flap thickness, a ferromagnet assembly 220 having a second portion 240 that is configured to provide a predetermined offset appropriate for the recipient's skin flap thickness, and either the clinician or the recipient can insert the selected ferromagnet assembly 220 in the cavity 210. At lower skin flap thicknesses, ferromagnetic assemblies 220 with weaker magnetic force can be prescribed, and at higher skin flap thicknesses, ferromagnetic assemblies 220 with stronger magnetic force can be prescribed (e.g., to ensure adequate retention of the at least one external inductive communication coil on the recipient). In certain embodiments, the selected ferromagnet assembly 220 also displaces the at least one external inductive communication coil to reduce a coupling coefficient between the at least one external inductive communication coil and the at least one internal inductive communication coil as compared to a coupling coefficient between the at least one external inductive communication coil and the at least one internal inductive communication coil with no offset in the direction parallel to the portion of skin 158.
It is to be appreciated that the embodiments disclosed herein are not mutually exclusive and may be combined with one another in various arrangements.
The invention described and claimed herein is not to be limited in scope by the specific example embodiments herein disclosed, since these embodiments are intended as illustrations, and not limitations, of several aspects of the invention. Any equivalent embodiments 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 embodiments disclosed herein, but should be defined only in accordance with the claims and their equivalents.
Filing Document | Filing Date | Country | Kind |
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PCT/IB2019/057124 | 8/23/2019 | WO | 00 |
Number | Date | Country | |
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62723222 | Aug 2018 | US |