Offset processor notification

Abstract

An apparatus includes a component configured to be placed over a skin portion of a recipient, the skin portion overlying an implanted device. The apparatus also includes first circuitry within the component and configured to wirelessly communicate with second circuitry within an implanted device. The first circuitry has a set of optimal operating positions relative to the second circuitry. The apparatus also includes third circuitry configured to detect at least one parameter indicative of a displacement of the first circuitry from the set of optimal operating positions, and generate at least one signal indicative of a magnitude and / or direction for moving the first circuitry towards the set of optimal operating positions.

Description

background Technical Field

[0001] The present application relates generally to implantable medical systems, and more particularly to systems having an external portion and an implanted portion configured to wirelessly communicate with each other transdermally. Background Art

[0002] Medical devices having one or more implantable components, generally referred to herein as implantable medical devices, have provided a wide range of therapeutic benefits to recipients in recent decades. Specifically, partially or fully implantable medical devices, such as hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), implantable pacemakers, defibrillators, functional electrical stimulation devices, and other implantable medical devices have been successfully used for many years to perform life-saving and / or lifestyle-improving functions and / or recipient monitoring.

[0003] Over the years, the types of implantable medical devices and the range of functions performed by them have increased. For example, many implantable medical devices now typically include one or more instruments, devices, sensors, processors, controllers, or other functional mechanical or electrical components that are permanently or temporarily implanted in the recipient's body. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage disease / injury or its symptoms, or to study, replace, or modify anatomical structures or physiological processes. Many of these functional devices utilize power and / or data received from an external device that is part of or operates in conjunction with the implantable medical device. Summary of the invention

[0004] In one aspect disclosed herein, a device includes a component configured to be placed over a portion of a recipient's skin that overlies an implanted device. The device also includes a first circuit system within the component. The first circuit system is configured to wirelessly communicate with a second circuit system within the implanted device. The first circuit system has a set of optimal operating positions relative to the second circuit system. The device also includes a third circuit system configured to detect at least one parameter indicating a displacement of the first circuit system from the set of optimal operating positions and generate at least one signal indicating a magnitude and / or direction for moving the first circuit system toward the set of optimal operating positions.

[0005] In another aspect disclosed herein, a method includes prompting a user to sequentially position an external device external to a recipient's body at a series of positions relative to an internal device within the recipient's body. The external device includes at least one external communication coil, and the internal device includes at least one internal communication coil. The method also includes receiving data indicating measured coupling values ​​between the at least one external communication coil and the at least one internal communication coil. The measured coupling values ​​are measured using the at least one external communication coil at different positions in the series of positions. The method also includes determining an optimal position for the external device. The optimal position corresponds to a maximum coupling value obtained using the measured coupling values.

[0006] In yet another aspect disclosed herein, a method includes receiving at least one first measurement of inductive coupling between an external device external to a recipient's body and an internal device within the recipient's body. The method also includes accessing data corresponding to second measurements of inductive coupling between other external devices external to other recipients' bodies and other internal devices within the bodies of the other recipients. The method also includes comparing the first measurement to the second measurement. The method also includes generating an assessment of the inductive coupling between the external device and the internal device in response to the comparison.

[0007] In yet another aspect disclosed herein, a system includes a component having an outer surface portion configured to be placed over a skin portion of a recipient, the skin portion overlying an implanted device. The system also includes a first magnet within the housing, the first magnet including a first substantially flat magnetic surface, the first substantially flat magnetic surface being configured to be substantially parallel to the skin portion and having a first north magnetic pole region and a first south magnetic pole region. The implanted device includes a second magnet having a second substantially flat magnetic surface, the second substantially flat magnetic surface being substantially parallel to the skin portion and having a second north magnetic pole region and a second south magnetic pole region. The system also includes a circuit system within the housing. The circuit system is configured to detect the configuration of the first magnet and the second magnet when the component is at least partially placed over the implanted device, and to generate at least one signal indicative of the configuration.

[0008] In yet another aspect disclosed herein, a method includes placing an external component of a medical device on the skin of a recipient such that only one of two magnetic poles of the external component overlies a corresponding one of two magnetic poles of an internal component of the medical device implanted in the recipient. The method also includes receiving one or more prompts from the medical device to adjust the placement of the external component on the skin of the recipient until both two magnetic poles of the external component overlie both corresponding two magnetic poles of the internal component. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Embodiments are described herein with reference to the accompanying drawings, in which:

[0010] Figure 1 is a perspective view of an exemplary cochlear implant hearing prosthesis implanted in a recipient according to certain embodiments described herein;

[0011] Figure 2 schematically illustrates a cross-sectional view of an exemplary apparatus according to certain embodiments described herein;

[0012] Figure 3A and 3B schematically illustrates two perspective views of an exemplary at least one first magnet and at least one exemplary second magnet according to certain embodiments described herein;

[0013] Figure 3C schematically illustrates a side view of four exemplary magnets compatible for use as at least one first magnet and / or at least one second magnet according to certain embodiments described herein;

[0014] Figure 4 schematically illustrates an exemplary device in two possible configurations according to certain embodiments described herein;

[0015] Figure 5 is a flow chart of an exemplary method according to certain embodiments described herein;

[0016] Fig. 6A and 6B schematically illustrates an exemplary image displayed on a user interface of a communication device visible to a user during a method according to some embodiments described herein;

[0017] Figure 6C schematically illustrates a baseline map using data received during a method according to certain embodiments described herein;

[0018] Fig. 7A and 7Bschematically illustrates an exemplary image displayed on a user interface of a communication device that is visible to a user when locating an external device according to certain embodiments described herein;

[0019] Figure 8 is a flowchart of an exemplary method according to certain embodiments described herein; and

[0020] Fig. 9 is a flow chart of another exemplary method according to certain embodiments described herein. DETAILED DESCRIPTION

[0021] Certain embodiments describe herein a system and method by which a medical device (e.g., a hearing prosthesis) has an implanted portion configured to wirelessly communicate transcutaneously with an external portion (e.g., via an RF link) via a magnetic induction coil. The medical device is capable of detecting and clearly notifying a user (e.g., a recipient; a medical practitioner) when the external portion is improperly positioned (e.g., lateral displacement; angular displacement; eccentricity; not ideally aligned) relative to an optimal placement (e.g., concentric and parallel), thereby adversely affecting transcutaneous wireless communication. Information indicating the relative displacement between the external portion and the internal portion can be obtained from measurements indicating link integrity and / or efficiency, and can be presented to the user as feedback information for positioning the external portion to achieve improved coupling. By facilitating avoidance of suboptimal coil placement, battery life can be improved and the recipient can experience fewer signal cutoffs during operation of the medical device. In addition, the recipient can be made more aware of device performance and can take steps to improve device performance. Moreover, comparison of data about the recipient's coupling with such data for other recipients can be used to generate guidance (e.g., recommendations) for improving the recipient's link integrity and efficiency.

[0022] In at least some embodiments, the teachings detailed herein are applicable to any type of implantable medical device, for example, a hearing prosthesis utilizing an implantable actuator assembly, including but not limited to: an electro-acoustic electrical / acoustic system, a cochlear implant device, an implantable hearing aid device, a middle ear implant device, a bone conduction device (e.g., an active bone conduction device, a passive bone conduction device, a transcutaneous bone conduction device, a transcutaneous bone conduction device), a direct acoustic cochlear implant (DACI), a middle ear transducer (MET), an electro-acoustic implant device, other types of hearing prosthesis devices, and / or combinations or variations thereof, or any other suitable hearing prosthesis system with or without one or more external components. Embodiments may include any type of medical device that may utilize the teachings detailed herein and / or variations thereof.

[0023] For ease of description only, the devices and methods disclosed herein are described primarily with reference to an exemplary medical device, namely an active transdermal or percutaneous hearing prosthesis system. Embodiments may include any type of hearing prosthesis capable of utilizing the teachings and / or variations thereof detailed herein. Certain such embodiments may be referred to as "partially implantable," "semi-implantable," "mostly implantable," "fully implantable," or "fully implantable" hearing prostheses. However, the teachings and / or variations thereof detailed herein may also be used with a variety of other medical systems or non-medical systems (e.g., other types of devices beyond hearing prostheses) that provide a wide range of therapeutic benefits to recipients, patients, or other users. For example, the concepts described herein may be applied to any of a variety of implantable medical devices (e.g., pacemakers; implantable EEG monitoring devices; implantable epileptic seizure monitoring devices; visual prostheses) that utilize the transfer of power and / or data between an implanted component and an external component via inductive coupling.

[0024] Figure 1 is a perspective view of an exemplary cochlear implant hearing prosthesis 100 implanted in a recipient according to certain embodiments described herein. Figure 1 1 is shown as including an implantable stimulator unit 120 (e.g., an actuator) and an external microphone assembly 124 (e.g., a partially implantable cochlear implant). An exemplary hearing prosthesis 100 (e.g., a fully implantable cochlear implant) according to certain embodiments described herein may be replaced by a subcutaneously implantable assembly including an acoustic transducer (e.g., a microphone). Figure 1 , as more fully described herein.

[0025] like Figure 1 As shown in FIG. 1 , a recipient typically has an outer ear 101, a middle ear 105, and an inner ear 107. In a fully functional ear, the outer ear 101 includes an auricle 110 and an ear canal 102. Sound pressure or sound waves 103 are collected by the auricle 110 and directed into and through the ear canal 102. Across the distal end of the ear canal 102 is disposed an eardrum 104 that vibrates in response to the sound waves 103. The vibration is coupled to an oval window or an ovate window 112 through three bones of the middle ear 105, which are collectively referred to as ossicles 106 and include a malleus 108, an incus 109, and a stapes 111. The bones 108, 109, and 111 of the middle ear 105 serve to filter and amplify the sound waves 103, thereby causing the oval window 112 to articulate or vibrate in response to the vibration of the eardrum 104. This vibration sets up fluid motion waves of the perilymph within the cochlea 140. This fluid movement, in turn, activates tiny hair cells (not shown) inside the cochlea 140. The activation of the hair cells causes appropriate nerve impulses to be generated and transmitted through spiral ganglion cells (not shown) and the auditory nerve 114 to the brain (also not shown) where they are perceived as sound.

[0026] like Figure 1 As shown in FIG. 1 , an exemplary hearing prosthesis 100 includes one or more components that are temporarily or permanently implanted in a recipient. Figure 1 14 is shown as having: an external component 142 that is attached directly or indirectly to the body of the recipient; and an internal component 144 that is temporarily or permanently implanted in the recipient's body (e.g., positioned in a recess of the temporal bone adjacent to the recipient's auricle 110). The external component 142 typically includes one or more input elements / devices for receiving input signals at the sound processing unit 126. The one or more input elements / devices may include one or more sound input elements (e.g., one or more external microphone assemblies 124) and / or one or more auxiliary input devices ( Figure 1 (not shown) (e.g., audio port, such as direct audio input (DAI); data port, such as a universal serial bus (USB) port; cable port, etc.). Figure 1 In the example of the embodiment, the sound processing unit 126 is a behind-the-ear (BTE) sound processing unit that is configured to be attached to the ear of the recipient and worn near the ear of the recipient. However, in certain other embodiments, the sound processing unit 126 has other arrangements, such as through an OTE processing unit (e.g., a component having a generally cylindrical shape and configured to be magnetically coupled to the head of the recipient), a mini or micro BTE unit, an in-ear canal unit configured to be located in the ear canal of the recipient, a body-worn sound processing unit, etc.

[0027] Certain embodiments of the sound processing unit 126 include a power supply ( Figure 1 (not shown) (such as a battery), a processing module ( Figure 1 ) (e.g., including one or more digital signal processors (DSPs), one or more microcontroller cores, one or more application specific integrated circuits (ASICs), firmware, software, etc., arranged to perform signal processing operations), and an external transmitter unit 128. Figure 1 In an illustrative embodiment of the invention, the external transmitter unit 128 includes a circuit system that includes at least one external inductive communication coil 130 (e.g., a wire antenna coil including multiple turns of electrically insulated single or multiple strands of platinum or gold wire). The external transmitter unit 128 generally also includes a magnet ( Figure 1 1). At least one external inductive communication coil 130 of the external transmitter unit 128 is part of an inductive radio frequency (RF) communication link with the internal component 144. The sound processing unit 126 processes the sound from the input element / device (e.g., the external microphone assembly 124, which is Figure 1The sound processing unit 126 generates a coded signal, sometimes referred to herein as a coded data signal, which is provided (e.g., via a cable) to an external transmitter unit 128. It will be appreciated that the sound processing unit 126 can utilize digital processing techniques to provide frequency shaping, amplification, compression, and other signal conditioning, including conditioning based on recipient-specific fitting parameters.

[0028] The power source of the external component 142 is configured to provide power to the hearing prosthesis 100, wherein the hearing prosthesis 100 includes a battery (e.g., located in the internal component 144, or disposed in a separate implant location) that is recharged by power provided by the external component 142 (e.g., via a transdermal energy transfer link). The transdermal energy transfer link is used to transfer power and / or data to the internal component 144 of the hearing prosthesis 100. Various types of energy transfer (e.g., infrared (IR), electromagnetic, capacitive, and inductive transfer) can be used to transfer power and / or data from the external component 142 to the internal component 144. During operation of the hearing prosthesis 100, the power stored by the rechargeable battery is distributed to various other implanted components as needed.

[0029] The internal components 144 include an internal receiver unit 132, a stimulator unit 120, and an elongated electrode assembly 118. In some implementations, the internal receiver unit 132 and the stimulator unit 120 are hermetically sealed within a biocompatible housing, which is sometimes collectively referred to as a stimulator / receiver unit. The internal receiver unit 132 includes at least one internal inductive communication coil 136 (e.g., a wire antenna coil including multiple turns of electrically insulated single or multiple strands of platinum or gold wire) and generally includes a magnet ( Figure 1 1 ), which is fixed relative to at least one internal inductive communication coil 136. At least one internal inductive communication coil 136 receives power and / or data signals from at least one external inductive communication coil 130 via a transcutaneous energy transfer link (e.g., an inductive RF link). The stimulator unit 120 generates an electrical stimulation signal based on the data signal, and the stimulation signal is delivered to the recipient via the elongated electrode assembly 118.

[0030] The elongated 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 through the mastoid bone 119 to the cochlea 140. In some embodiments, the electrode assembly 118 can be implanted at least in the basal region 116, and sometimes implanted further. For example, the electrode assembly 118 can extend toward the top of the cochlea 140 (called the cochlear apex 134). In some cases, the electrode assembly 118 can be inserted into the cochlea 140 via a cochlear window 122. In other cases, the cochlear window can be formed by the round window 121, the oval window 112, the promontory 123, or by the apical gyrus 147 of the cochlea 140.

[0031] The elongated electrode assembly 118 includes a longitudinally aligned and distally extending array 146 of electrodes 148 (e.g., contacts) disposed along its length, sometimes referred to herein as an electrode or contact array 146. 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.

[0032] Figure 2 Schematically illustrated is a cross-sectional view of an exemplary device 200 according to certain embodiments described herein. The device 200 includes a component 202 configured to be placed over a skin portion 150 of a recipient, the skin portion 150 overlying an implanted device 300. The device 200 also includes a first circuit system 210 within the component 202, the first circuit system 210 configured to wirelessly communicate with a second circuit system 320 within the implanted device 300. The first circuit system 210 has a set of optimal operating positions 212 relative to the second circuit system 320. The device 200 also includes a third circuit system 230 configured to detect at least one parameter indicating displacement of the first circuit system 210 from the set of optimal operating positions 212, and to generate at least one signal indicating a magnitude and / or direction 240 for moving the first circuit system 210 toward the set of optimal operating positions 212.

[0033] In some embodiments, component 202 is an implantable medical device (e.g., a hearing prosthesis system; e.g., a Figure 1The schematically illustrated cochlear implant hearing prosthesis 100) is an external component 142 of an implantable medical device, and the implanted device 300 is an internal component 144 of an implantable medical device. For example, the component 202 can be an external component 142 of a hearing prosthesis system selected from the group consisting of: a cochlear implant system, a direct acoustic cochlear implant (DACI) system, a middle ear implant system, a middle ear transducer (MET) system, an electroacoustic implant system, another type of hearing prosthesis system, and / or combinations or variations thereof.

[0034] In some embodiments, the component 202 includes a housing 204 (e.g., including a polymer material and / or other material compatible to be placed in contact with the surface 152 of the recipient's skin 150), which contains a first circuit system 210 (e.g., an external transmitter unit 128 including at least one external inductive communication coil 130) and a third circuit system 230, as well as other elements of the component 202 (e.g., at least one external microphone assembly 124, a sound processing unit 126, and / or a power supply). For example, the first circuit system 210, the third circuit system 230, and the other elements of the component 202 can be contained within one or more cavities (e.g., a hermetic sealing area) of the housing 204. In some embodiments, the housing 204 includes an outer surface portion 205 configured to be placed above and substantially parallel to the skin portion 150.

[0035] In some embodiments, the implantable device 300 includes an implantable housing 310 (e.g., comprising titanium, a polymer, a ceramic, or other biocompatible material compatible to be implanted beneath the skin 150 and other tissue 154 (such as muscle and / or fat) of a recipient), the implantable housing containing a second circuit system 320 (e.g., at least one internal inductive communication coil 136) and other elements of the implantable device 300 (e.g., an implanted receiver unit 132, a stimulator unit 120, and / or an elongated electrode assembly 118). For example, the second circuit system 320 and other elements of the implantable device 300 can be contained within one or more cavities (e.g., a hermetic seal area) of the implantable housing 310. In some embodiments, the implantable housing 310 of the implantable device 300 is configured to be secured to a bone surface (e.g., a skull surface) beneath the skin 150 and other tissue 154.

[0036] In certain embodiments, the apparatus 200 further includes at least one first magnet 206 mounted within the component 202 (e.g., within a cavity of the housing 204), and the implantable device 300 includes at least one second magnet 306 within the implanted device 300 (e.g., hermetically sealed within the implantable housing 310). The at least one first magnet 206 can be configured to generate a magnetic attraction force with the at least one second magnet 306 within the implanted device 300. The attraction force can be configured to hold the component 202 on the surface 152 of the skin portion 150, wherein the first circuit system 210 is in a set of optimal operating positions 212. Magnets compatible with certain embodiments described herein include, but are not limited to, axially magnetized ferromagnets (e.g., axial magnets) and radially magnetized ferromagnets (e.g., radial magnets). In certain other embodiments, component 202 and / or implanted device 300 do not include magnets, and component 202 is held on surface 152 of skin portion 150 by other forces (e.g., from external pressure applied to component 202), and device 200 provides guidance regarding optimal external coil placement.

[0037] In some embodiments, the first circuit system 210 includes a first planar inductor coil (e.g., at least one external inductive communication coil 130 of the external transmitter unit 128), the first planar inductor coil having a first number of turns and a first planar area, and the second circuit system 320 includes a second planar inductor coil (e.g., at least one internal inductive communication coil 136 of the internal receiver unit 132), the second planar inductor coil having a second number of turns and a second area. The first planar inductor coil can be configured to inductively communicate with the second planar inductor coil. In some embodiments in which the component 202 includes at least one first magnet 206 and the implantable device 300 includes at least one second magnet 306, the first planar inductor coil can surround the at least one first magnet 206 and / or a projection of the at least one first magnet 206 onto a plane defined by the first planar inductor coil, and the second planar inductor coil can surround the at least one second magnet 306 and / or a projection of the at least one second magnet 306 onto a plane defined by the second planar inductor coil.

[0038] In some embodiments, the first circuit system 210 and the second circuit system 320 form a transcutaneous inductive radio frequency (RF) communication link between the device 200 and the implanted device 300 (e.g., the first circuit system 210 and the second circuit system 320 interact with each other via magnetic flux passing through the first circuit system 210, 320 of one of the first circuit system 210, 320) through which the implanted device 300 receives power and / or data signals from the device 200. In some embodiments, when the device 200 is placed in an operating position, the first circuit system 210 is substantially centered above the second circuit system 320. For example, the central axis of the first circuit system 210 can be substantially coincident with the central axis of the second circuit system 320.

[0039] In some embodiments, the inductive coupling (e.g., mutual inductance; coupling coefficient) between the first circuit system 210 and the second circuit system 320 depends on the displacement between the first circuit system 210 and the second circuit system 320, where a larger displacement corresponds to a weaker inductive coupling. For example, a larger displacement in a direction substantially perpendicular to the skin (e.g., a larger flap thickness or SFT) can reduce the inductive coupling between the first circuit system 210 and the second circuit system 320, and a larger displacement in a direction substantially parallel to the skin 150 (e.g., a lateral displacement) can also reduce the inductive coupling between the first circuit system 210 and the second circuit system 320. In addition, the inductive coupling can be reduced by an angular displacement (e.g., tilt) between the first circuit system 210 and the second circuit system 320.

[0040] Certain embodiments described herein have a set of positions (e.g., a range of positions) (referred to herein as a set of optimal operating positions 212) at which the inductive coupling between the first circuit system 210 and the second circuit system 320 is optimal for operation of the device 200 (e.g., there is sufficiently efficient transmission of operating signals between the component 202 and the implanted device 300). For example, Figure 2 As shown in FIG. 1 , the first circuit system 210 may be located directly above the second circuit system 320 (in FIG. Figure 2214), thereby providing maximum overlap of the first and second regions and maximum inductive coupling, which provides maximum efficient signal transmission between component 202 and implanted device 300. However, the first circuit system 210 of certain embodiments can be displaced from this maximum coupling position (e.g., laterally displaced in a direction substantially parallel to skin portion 150; axially displaced in a direction substantially perpendicular to skin portion 150; angularly displaced to have an inclination relative to skin portion 150). For small displacements, the inductive coupling is less than the maximum inductive coupling, but is still sufficient for sufficiently efficient signal transmission between component 202 and implanted device 300. For large displacements (e.g., Figure 2 2 ), the inductive coupling is significantly less than the maximum inductive coupling and is insufficient for sufficiently efficient signal transmission. In some embodiments, a range of inductive coupling (e.g., mutual inductance; coupling coefficient) values ​​that are sufficient for sufficiently efficient signal transmission is predetermined, and a set of optimal operating positions 212 corresponds to this range of inductive coupling values. For example, a predetermined threshold inductive coupling value can separate sufficiently efficient signal transmission values ​​from insufficiently efficient signal transmission values.

[0041] Figure 3A and 3B Two perspective views of an exemplary at least one first magnet 206 and an exemplary at least one second magnet 306 are schematically illustrated according to certain embodiments described herein. Figure 3C Schematically illustrated are side views of four exemplary magnets (e.g., "4-pole" magnets; "Halbach" magnets; "angled Halbach" magnets; "angled 4-pole" magnets) that are compatible for use as at least one first magnet 206 and / or at least one second magnet 306 according to certain embodiments described herein. At least one first magnet 206 can include a radial magnet that is fixed to or within the housing 204 and has a first magnetic moment 207 (e.g., magnetization) that extends substantially parallel to the outer surface portion 205 (e.g., substantially parallel to the skin portion 150 when the first circuit system 210 is in a set of optimal operating positions 212). At least one second magnet 306 can include a radial magnet that is within the implantable housing 310 and has a second magnetic moment 307 (e.g., magnetization) that extends substantially parallel to the skin portion 150. In the context of hearing prostheses, an implanted device 300 having a rotatable radially implanted magnet 306 can provide compatibility with magnetic resonance imaging (MRI) by causing the implanted magnet 306 to rotate about its central axis in response to a torque induced by a large MRI magnetic field interacting with the implanted magnet 306, thereby avoiding pain and / or damage to the recipient and / or the hearing prosthesis.

[0042] Various configurations of at least one first magnet 206 and at least one second magnet 306 may also be compatible with certain embodiments described herein. For example, at least one second magnet 306 may include a plurality of cylinders configured to rotate, wherein the magnetic attraction between the cylinders is greater than the magnetic attraction of at least one first magnet 206 (e.g., at least one second magnet 306 acts as a radially magnetized magnet, which can be very strong and can overcome the cylinder-cylinder magnetic attraction except in the presence of an MRI field). As another example, at least one first magnet 206 and / or at least one second magnet 306 may each include a first portion having a first magnetization and a second portion having a second magnetization, wherein the second magnetization has a non-zero skew angle or orthogonal angle relative to the first magnetization. In certain embodiments, a set of optimal operating positions 212 of the first circuit system 210 corresponds to a non-zero offset between at least one first magnet 206 and at least one second magnet 306.

[0043] like Figure 3A and 3B As shown in , at least one first magnet 206 of certain embodiments includes a single (e.g., one-piece) body having two halves (e.g., two semicircular portions), the two halves including a single first north pole (labeled “N”) and a single first south pole (labeled “S”). At least one first magnet 206 of certain other embodiments includes a plurality of first north poles and a plurality of first south poles (see, e.g., Figure 3C At least one first magnet 206 of certain embodiments includes a substantially planar outer surface 208 (e.g., a lower surface closest to the skin portion 150) that is configured to be substantially parallel to the skin portion 150 and having a single first north magnetic pole region and a single first south magnetic pole region (see, e.g., Figures 3A-3C ).

[0044] Similarly, if Figure 3A and 3B As shown in , at least one second magnet 306 of certain embodiments includes a single (e.g., one-piece) body having two halves (e.g., two semicircular portions), the two halves including a single second north pole (labeled “N”) and a single second south pole (labeled “S”). At least one second magnet 306 of certain other embodiments includes a plurality of second north poles and a plurality of second south poles (see, e.g., Figure 3C At least one second magnet 306 of certain embodiments includes a substantially flat outer surface 308 (e.g., an upper surface closest to the skin portion 150) that is configured to be substantially parallel to the skin portion 150 and having a single second north magnetic pole region and a single second south magnetic pole region.

[0045] Each of the at least one first magnet 206 and the at least one second magnet 306 may include at least one ferromagnetic material selected from the group consisting of: iron, nickel, cobalt, neodymium, and steel. Figures 3A-3C At least one first magnet 206 and at least one second magnet 306 are shown to have a right cylindrical shape with a central axis substantially perpendicular to the corresponding magnetic moment, but other shapes (e.g., circular; oval; square; rectangular; polygonal; geometric; irregular; symmetrical; asymmetrical; shapes with straight, curved or irregular sides) are also compatible with certain embodiments described herein. In certain embodiments, as Figures 3A-3C , one or both of the at least one first magnet 206 and the at least one second magnet 306 are a single (e.g., integral) magnet, while in certain other embodiments, one or both of the at least one first magnet 206 and the at least one second magnet 306 each include multiple magnets.

[0046] In certain embodiments, the magnetic attraction between the at least one first magnet 206 and the at least one second magnet 306 facilitates positioning of the component 202 relative to the implanted device 300. For example, when the component 202 is moved sufficiently close to the implanted device 300 to generate the magnetic attraction, the magnetic attraction acts to position the component 202 such that the at least one first magnet 206 is directly above the at least one second magnet 306, wherein the first magnetic moment 207 is substantially parallel to and opposite to the second magnetic moment 307 (e.g., as indicated by Figure 3A and 3B Schematically illustrated). The fixed position of the first circuit system 210 relative to at least one first magnet 206 within the component 202 and the fixed position of the second circuit system 320 relative to at least one second magnet 306 within the implanted device 300 can be configured such that the magnetic attraction provides sufficient retention to maintain the component 202 on the surface 152 of the skin portion 150, wherein the first circuit system 210 is positioned relative to the second circuit system 320 within a set of optimal operating positions 212 (e.g., the first circuit system 210 is centered above and / or concentric with the second circuit system 320). Although Figure 3A and 3B It is schematically shown that each of at least one first magnet 206 and at least one second magnet 306 includes a radial magnet whose corresponding first magnetic moment 207, 307 extends substantially parallel to the skin portion 150, but in certain other embodiments, each of at least one first magnet 206 and at least one second magnet 306 includes an axial magnet whose corresponding first magnetic moment 207, 307 extends substantially perpendicular to the skin portion 150.

[0047] Figure 4An exemplary device 200 having at least one first magnet 206 and at least one second magnet 306 in two possible configurations according to certain embodiments described herein is schematically illustrated. The at least one first magnet 206 of the component 202 comprises a first radial magnet having a north pole and a south pole (e.g., see Figure 3A-3B ;exist Figure 4 ), and the at least one second magnet 306 of the implanted device 300 includes a second radial magnet having a north pole and a south pole (e.g., see Figure 3A-3B ;exist Figure 4 are shown with different shading). Figure 4 The at least one second magnet 306 is configured to freely rotate in a plane substantially parallel to the skin portion 150 (e.g., rotate about an axis of rotation substantially perpendicular to the skin portion 150) while being retained within the implantable housing 310 of the implanted device 300.

[0048] exist( Figure 4 In a first configuration 410 (shown in the upper right portion of FIG), component 202 is positioned above implanted device 300, wherein at least one first magnet 206 is directly above (e.g., concentric with; axially aligned with) at least one second magnet 306 of implanted device 300. Although Figure 4 150, but the at least one second magnet 306 has been rotated in a plane substantially parallel to the skin portion 150 so that the second north pole is directly below the first south pole and the second south pole is directly below the first north pole (e.g., providing maximum holding force). In this first configuration 410, the first circuit system 210 is directly above (e.g., concentric with; axially aligned with) the second circuit system 320, thereby providing maximum inductive coupling between the first circuit system 210 and the second circuit system 320.

[0049] However, in other configurations, the component 202 can be placed above the implanted device 300, wherein the first circuit system 210 has a displacement 430 from the set of optimal operating positions 212 (e.g., the first configuration 410). For example, the at least one second magnet 306 can be rotated when the component 202 is placed above the implanted device 300, and as shown in FIG. Figure 4As shown in the exemplary second configuration 420 in the lower right portion of , at least one first magnet 206 can be laterally offset from at least one second magnet 306 (e.g., not concentric therewith; not aligned axially therewith), wherein the corresponding first circuit system 210 is laterally displaced (e.g., offset) from the second circuit system 320. In this exemplary second configuration 420, only one of the two poles of the at least one second magnet 306 is directly below the opposite pole of the at least one first magnet 206 (e.g., providing some holding force, but less than a maximum holding force), and the first circuit system 210 is laterally offset from the second circuit system 320 (e.g., not concentric therewith; not aligned axially therewith), thereby providing an inductive coupling that is less than the maximum inductive coupling between the first circuit system 210 and the second circuit system 320. Although Figure 4 An exemplary second configuration 420 is schematically shown having a displacement 430 that includes a lateral displacement (e.g., an offset) in a direction substantially parallel to the skin portion 150, but other second configurations 420 compatible with certain embodiments described herein may include an axial displacement of the first circuit system 210 from the second circuit system 320 (e.g., in a direction substantially perpendicular to the skin portion 150) and / or an angular displacement (e.g., a tilt) between the first circuit system 210 and the second circuit system 320.

[0050] In certain embodiments, it may be difficult for a recipient or user to place the component 202 in an operational position relative to the implanted device 300 (under the skin 150) to distinguish whether the component 202 is properly positioned relative to the implanted device 300 (e.g., to distinguish between a first configuration 410 that provides maximum or optimal inductive coupling and a second configuration 420 that provides less inductive coupling). A device 200 having only a simple binary notification scheme (e.g., with an on / off LED indication corresponding to good / poor positioning) may not be able to reliably distinguish between a less desirable second configuration 420 and an optimal first configuration 410. In addition, the positioning procedure for avoiding the second configuration 420 may be complex and difficult for the recipient to follow. Operating the device 200 in the second configuration 420 with less retention force and less inductive coupling may create various problems, including, but not limited to: reduced battery life of the component 202; unsatisfactory retention of the component 202 on the surface 152 of the skin portion 150; communication errors between the component 202 and the implanted device 300 resulting in loss of operation.

[0051] Moreover, in the context of surgical use cases, where a newly inserted implanted device 300 is tested prior to closing a surgical site, even though the implanted device 300 may not be shielded by tissue, it may be difficult for a practitioner (e.g., surgeon; nurse) to know when the first circuit system 210 of the component 202 (e.g., the test device) is properly aligned with the second circuit system 320 of the implanted device 300, which creates frustration and delays during surgery. The optimal positioning of the first circuit system 210 may be constrained by the surgical drape, and / or the increased SFT range due to tissue swelling may increase the effective coil-to-coil spacing up to and beyond 16 mm, and misalignment may further increase the effective spacing. For example, a longitudinal offset of 5 mm between the first circuit system 210 and the second circuit system 320 may be equivalent to an increase in SFT of approximately 3 mm, an angular offset of 15 degrees between the first circuit system 210 and the second circuit system 320 may be equivalent to an increase in SFT of approximately 5 mm, and a combination of these longitudinal and angular offsets may be equivalent to an increase in SFT of approximately 7 mm. Magnets cannot be used as a measure of optimal coil alignment in all of these situations. A wireless communication link capable of operating at a total effective spacing of approximately 23 mm and operating without certain embodiments described herein may provide an optimal user experience during surgical use. However, certain embodiments described herein are configured to provide an optimal user experience and / or improve the ease and accuracy of positioning the test device (e.g., reducing the likelihood of frustration and / or delays) with a wireless communication link capable of operating at approximately 10 mm.

[0052] In some embodiments, the third circuit system 230 is configured to detect at least one parameter indicative of the displacement 430 and provide guidance information to a user (e.g., a recipient; a practitioner) to facilitate proper operational positioning of the component 202 relative to the implanted device 300. In some embodiments, as described by Figure 2Schematically illustrated, the third circuit system 230 is within the component 202, while in certain other embodiments, the third circuit system 230 is within the implanted device 300 or within a device separate from both the component 202 and the implanted device 300 (e.g., a smartphone, a smart tablet, a smart watch, or other remote device operated by a user and communicating with the component 202 and / or the implanted device 300). The third circuit system 230 of certain embodiments includes at least one microcontroller configured to receive a detection signal indicating at least one parameter and generate an output signal in response. The at least one microcontroller may include at least one application specific integrated circuit (ASIC) microcontroller, a digital signal processing (DSP) microcontroller, a general purpose integrated circuit programmed by software having computer executable instructions, and / or a microcontroller core. In certain embodiments, the third circuit system 230 and the first circuit system 210 include different portions of the same circuit system (e.g., a single microcontroller), while in certain other embodiments, the third circuit system 230 and the first circuit system 210 include portions of different microcontrollers. In certain embodiments, the third circuit system 230 includes and / or is in operative communication with a storage circuit system configured to store information (e.g., data; commands) accessed by the third circuit system 230 during operation (e.g., when providing the functionality of certain embodiments described herein). The storage circuit system may include at least one tangible (e.g., non-transitory) computer-readable storage medium, examples of which include, but are not limited to: read-only memory (ROM); random access memory (RAM); magnetic disk storage media; optical storage media; flash memory. The storage circuit system may be encoded with software (e.g., a computer program downloaded as an application) that includes computer-executable instructions for instructing the third circuit system 230 (e.g., executable data access logic, evaluation logic, and / or information output logic). In certain embodiments, the third circuit system 230 executes the instructions of the software to provide the functionality as described herein. The third circuit system 230 of certain embodiments also includes other digital circuit systems (e.g., registers; filters; output controllers; memory controllers).

[0053] In some embodiments, the at least one parameter includes a magnetic field strength of an attractive magnetic field between the at least one first magnet 206 and the at least one second magnet 306. For example, the third circuit system 230 may include a magnetic field detection circuit (e.g., a Hall effect sensor) configured to generate a detection signal indicating the strength of the attractive magnetic field.

[0054] In some embodiments, the at least one parameter indicates the efficiency and / or data integrity of the communication between the first circuit system 210 and the second circuit system 320. In some embodiments, the at least one parameter includes the mutual inductance of the first circuit system 210 (e.g., at least one external inductive communication coil 130) and the second circuit system 320 (e.g., at least one internal inductive communication coil 136), the communication power consumption rate between the first circuit system 210 and the second circuit system 320, the voltage or attenuation rate received by the implanted device 300, or the radio frequency (RF) communication efficiency between the first circuit system 210 and the second circuit system 320. For example, the third circuit system 230 can be configured to receive a detection signal indicating an input voltage, current, and / or power provided to the first circuit system 210 (e.g., from the first circuit system 210) and / or receive a detection signal indicating an output voltage, current, and / or power received by the second circuit system 320 (e.g., from the second circuit system 320 via reverse link telemetry). In some embodiments, at least one parameter includes the number of communication errors or the communication error rate between the first circuit system 210 and the second circuit system 320 (e.g., a cyclic redundancy check or CRC of a signal transmitted between the first circuit system 210 and the second circuit system 320 via reverse link telemetry). For example, one of the first circuit system 210 and the second circuit system 320 may transmit a test communication signal to the other of the first circuit system 210 and the second circuit system 320, and the third circuit system 230 may detect the number of communication errors and / or the communication error rate of these transmitted test communication signals (e.g., within a predetermined time period). Certain such embodiments may be configured in firmware and / or software of the device 200 without requiring additional hardware.

[0055] In some embodiments, the device 200 includes a user interface configured to generate audio, visual, and / or tactile indicia in response to at least one signal to convey to the user a magnitude and / or direction for moving the first circuit system 210 toward a set of optimal operating positions 212. These indicia can be configured to provide information to the user used by the user in deciding whether the component 202 should be moved to improve the coupling of the first circuit system 210 with the second circuit system 320 (e.g., feedback indicating relative alignment compared to a previous baseline and guidance for improving alignment). This information can be in the form of a hotter / colder indication (e.g., hotter corresponds to closer to optimal positioning, colder corresponds to further away from optimal positioning) or other types of indications. For example, at least one signal and / or indicia can indicate a non-zero magnitude (e.g., so that the movement of the first circuit system 210 is justified). As another example, the measured value of at least one parameter can be converted into a score, and the range of these scores can correspond to a poor, medium, or optimal connection between the first circuit system 210 and the second circuit system 320, where the current score is displayed to the user. When the user interface indicates that the optimal operating position has been reached, the user may then know to keep the component 202 and the first circuit system 210 in the proper position.

[0056] For example, the user interface may include a light source (e.g., one or more light emitting diodes) configured to display a color and / or flash at a rate indicating a magnitude and / or direction. When the first circuit system 210 is further away from a set of optimal operating positions 212, the light source may emit a first color (e.g., red), and / or may flash at a slow rate. When the first circuit system 210 is closer to a set of optimal operating positions 212, the light source may emit a second color (e.g., orange), and / or may flash at a faster rate. When the first circuit system 210 is in a set of optimal operating positions 212, the light source may emit a third color (e.g., green), and / or may be continuously turned on. As another example, the user interface may present other types of visual cues (e.g., a scale including a number of bars indicating the coupling strength or alignment quality between the first circuit system 210 and the second circuit system 320). In some embodiments, a plurality of light emitting diodes may be arranged in an array to display an arrow indicating the magnitude and / or direction of moving the first circuit system 210 toward a set of optimal operating positions 212.

[0057] For another example, the user interface may include a sound source (e.g., a speaker) configured to emit a tone and / or pulsate at a rate indicating a magnitude and / or direction. When the first circuit system 210 is further away from a group of optimal operating positions 212, the sound source may emit a first tone (e.g., a lower pitch), and / or may pulsate at a slow rate. When the first circuit system 210 is closer to a group of optimal operating positions 212, the sound source may emit a second tone (e.g., a higher pitch), and / or may pulsate at a faster rate. When the first circuit system 210 is in a group of optimal operating positions 212, the sound source may emit a third tone (e.g., the highest pitch), and / or may be continuously turned on. In certain embodiments in which the device 200 includes an auditory prosthesis, the user interface may include a stimulator unit 120 of an implanted device 300, which is configured to provide audio tags to a recipient.

[0058] As another example, the user interface may include a vibrator (e.g., a haptic motor) configured to emit different vibration waveforms indicating magnitude and / or direction. When the first circuit system 210 is further away from a set of optimal operating positions 212, the sound source may emit a first tone (e.g., a lower pitch), and / or may pulsate at a slow rate. When the first circuit system 210 is further away from a set of optimal operating positions 212, the vibrator may emit a first waveform (e.g., a smaller vibration magnitude and / or a slower vibration rate). When the first circuit system 210 is closer to a set of optimal operating positions 212, the vibrator may emit a second waveform (e.g., a larger vibration magnitude and / or a faster vibration rate). When the first circuit system 210 is in a set of optimal operating positions 212, the vibrator may emit a third waveform (e.g., the largest vibration magnitude and / or the fastest vibration rate).

[0059] In some embodiments, the third circuit system 230 is within the component 202 and / or the implanted device 300 and is configured to wirelessly transmit at least one signal to a communication device separate from the device 200. The communication device can be configured to generate an audio, visual, or tactile marker (e.g., the exemplary audio, visual, or tactile markers described above) in response to the at least one signal to convey the magnitude and / or direction to the user. The communication device can include a smartphone, a smart tablet, a smart watch, or other remote device operated by the user and configured to wirelessly communicate with the device 200 (e.g., WiFi; Bluetooth; a cell phone connection; a telephone; other Internet connection). In some embodiments in which the communication device includes a viewing screen or other display device, the visual marker can include at least one image (e.g., an arrow; a scale; a graph; a schematic diagram) displayed on the viewing screen. In certain other embodiments, at least a portion of the third circuit system 230 is within a device separate from both component 202 and implanted device 300 (e.g., a smartphone, smart tablet, smart watch, or other remote device operated by a user) and is configured to receive a signal indicating at least one parameter (e.g., from component 202 and / or implanted device 300) and detect whether the at least one parameter indicates that the first circuit system 210 is in a set of optimal operating positions or is displaced from a set of optimal operating positions.

[0060] In certain embodiments, the third circuit system 230 is configured to compare the measured values ​​of the at least one parameter with a set of optimal operating values ​​of the at least one parameter, the set of optimal operating values ​​corresponding to a set of optimal operating positions 212 of the first circuit system 210 relative to the second circuit system 320. For example, one or more initial measurements (e.g., readings) of the at least one parameter can be obtained when it is known that the first circuit system 210 is in a set of optimal operating positions 212 (e.g., it is known that the inductive communication coils 130, 136 are aligned with each other), and the one or more initial measurements can be stored in the storage circuit system as data indicating a set of optimal operating values. Later, when the component 202 is being positioned by the user over the implanted device 300, the third circuit system 230 can obtain the measured values ​​of the at least one parameter, compare these measured values ​​with the stored data indicating a set of optimal operating values, and generate guidance information for the user to use to move the component 202 to the appropriate operating position relative to the implanted device 300. In certain such embodiments, the storage circuitry further includes data (eg, a lookup table; a computational algorithm) relating measured values ​​of at least one parameter to corresponding magnitudes and / or directions for moving the first circuitry 210 toward a set of optimal operating positions 212 .

[0061] In certain other embodiments, the third circuit system 230 is configured to prompt a user (e.g., a recipient; a medical practitioner) to move the component 202 at a plurality of positions relative to the implanted device 300 while measuring the value of at least one parameter, and to determine from the measured values ​​a set of optimal operating positions 212. The user may be guided to establish an "ideal" alignment baseline to which subsequent alignment measurements may be compared, and corresponding feedback information may be provided to the user.

[0062] Figure 5 is a flow chart of an exemplary method 500 according to certain embodiments described herein. Figure 2 , 3A -3C and 4 of the exemplary device 200 structure to describe method 500, but other devices and systems with other configurations of components can also be used to perform method 500 according to certain embodiments described herein. For example, some or each of the operation blocks of method 500 can be performed using an external device configured to be operatively coupled to an implanted device, and / or some or each of the operation blocks of method 500 can be performed using a separate device that wirelessly communicates with an external device (e.g., a device including a viewing screen; a smart phone; a smart tablet; a smart watch; or other remote device). Fig. 6A and 6B An exemplary image displayed on a user interface of a communication device visible to a user during method 500 is schematically illustrated according to some embodiments described herein. Figure 6C Schematically illustrates a baseline map using data received during method 500 according to certain embodiments described herein. Figure 5 and 6A -6C method 500 is described in the context of aligning an external device with a previously implanted internal device, but in certain other embodiments, method 500 may be performed by a practitioner (e.g., a surgeon) during surgical implantation of an internal device, whereby the external device is a test device that is configured to be inserted into a surgical site to wirelessly couple to the internal device for testing the performance of the internal device.

[0063] In operation block 510, method 500 includes prompting a user to sequentially position an external device (e.g., component 202) external to a recipient's body at a series of locations relative to an internal device (e.g., implanted device 300) within the recipient's body. The external device (e.g., a sound processor of a hearing prosthesis system) may include at least one external communication coil (e.g., first circuit system 210), and the internal device (e.g., an implanted stimulation component of a hearing prosthesis system) may include at least one internal communication coil (e.g., second circuit system 320). For example, the user interface may prompt the user to move the external device around an approximate implantation location while measuring at least one parameter indicative of displacement (e.g., RF link efficiency), thereby performing a "mapping" of the recipient's body that may be used as a baseline for subsequent positioning of the external device.

[0064] like Fig. 6A As shown in , the viewing screen 610 may display an image 620 of the head and information (eg, arrows; text) prompting the user to move the external device to various positions close to the internal device. Figure 6B As shown in , as the user moves the external device as prompted, the viewing screen 610 can display in real time an image 630 with markers (e.g., shadows) indicating various positions of the external device to that point in the process. As the user continues to move the external device to more locations, the image 630 can be updated to provide feedback to the user as the external device is being moved. The images 620, 630 can include a schematic or generic diagram of a body part or an overlay of a camera image / video of the body part (e.g., augmented reality on a mobile camera).

[0065] In operation block 520, method 500 also includes receiving data 640 indicating measured coupling values ​​between at least one external communication coil and at least one internal communication coil. For example, data 640 may include values ​​indicating coupling that has been measured when at least one external communication coil is located at each different position in a series of positions. For example, the external device may perform link quality measurements while moving the external device. Examples of values ​​that may be measured include, but are not limited to: internal device power and / or voltage values; external device power and / or voltage values; the number of errors and / or error rates in wireless data transmission between the external device and the internal device. Data 640 may also include location information indicating the location of the external device at which values ​​have been measured (e.g., when the external device performs link quality measurements). For example, as Figure 6C As shown in FIG. 6 , data 640 may include the x-coordinate and y-coordinate of the external device when the user moves the external device ( Figure 6C642). Examples of sensors that can generate position information include, but are not limited to: sensors on or within the external device (e.g., accelerometers; gyroscopes; magnetic field sensors; optical sensors sensitive to visible and / or invisible light; acoustic sensors), sensors separate from the external device (e.g., computer vision and / or image recognition sensors; mobile cameras), and combinations thereof.

[0066] At operation block 530, method 500 further includes determining at least one optimal position 650 of the external device (e.g., a set of optimal operating positions 212). At least one optimal position 650 may correspond to a maximum value among the measured values. Figure 6C As shown in FIG. 5 , an external device or other device used to perform method 500 may derive a data structure including contour line 660 (eg, Figure 6C 6 (shown as dashed lines in FIG. 6 ), wherein each contour line tracks an x-coordinate and a y-coordinate of a measurement value that is substantially equal to one another. Each of the contour lines 660 may be derived (e.g., interpolated) from two or more of the value data points 642 of the data 640. In addition, the graph may include at least one optimal position 650 ( Figure 6C 640, at least one optimal position 650, and / or the derived contour line 660 can be displayed by a user interface (e.g., to indicate to the user where the best link quality is located, and therefore where to position the implant device).

[0067] In some embodiments, the baseline mapping may be performed by a medical practitioner during an initial fitting procedure of the device 200 to the recipient, while in some other embodiments, the baseline mapping may be performed at various times when the recipient wears the device 200. In some such embodiments, the method 500 may also include triggering a prompt of the operation block 510 (e.g., prompts of other operation blocks 520, 530) when the external device is being placed on the recipient's body. For example, the trigger may occur automatically when the external device is moved from a first position having a coupling value less than a predetermined threshold to a second position having a coupling value greater than a predetermined threshold (e.g., the external device is placed sufficiently close to the implanted device). As another example, the trigger may occur automatically when a wireless communication link (e.g., a Bluetooth connection) is established or reestablished between the external device and the internal device. As another example, the trigger may occur automatically after a predetermined time period has passed. In other examples, the trigger may occur when an input signal is received from a user indicating that the user wishes to refresh the determination of the optimal position (e.g., manually triggered by the recipient). The trigger input signal may be input from a user interface of the external device or a separate device (eg, a smart phone, smart tablet, smart watch, or other remote device) that is in wireless operational communication with the external device.

[0068] In certain embodiments where the data 640, at least one optimal position 650, and / or the contour line 660 are used as a baseline for subsequently positioning the external device, the user interface can provide real-time (e.g., live) guidance about where the external device should be placed to obtain optimal link quality. In certain embodiments, the real-time guidance utilizes information about the real-time position of the external device. For example, the position can be monitored in real time by one or more sensors, including but not limited to: sensors on or within the external device (e.g., accelerometers; gyroscopes; magnetic field sensors; optical sensors sensitive to visible and / or invisible light; acoustic sensors), sensors separate from the external device (e.g., computer vision and / or image recognition sensors; mobile cameras), and combinations thereof.

[0069] Fig. 7A and 7B Schematically illustrates an exemplary image displayed on a user interface (e.g., viewing screen 610) of a communication device that is visible to a user when positioning an external device according to certain embodiments described herein. Fig. 7AAs shown in , the user interface can display an image 670 that includes a representation of the recipient's body, external device, and / or internal device and indicia (e.g., arrows; text) indicating a magnitude and / or direction for moving the external device (e.g., component 202 including first circuit system 210) toward at least one optimal position 650. When the external device is being positioned at at least one optimal position 650, as shown in FIG. Figure 7B As shown in , the user interface can display an image 680 that includes a representation of the recipient's body, the external device and / or the internal device and indicia (e.g., text; symbols) indicating that the external device is successfully positioned to directly overlie the internal device and optimally couple with the internal device.

[0070] In some embodiments, measurement data indicative of alignment during and / or after performance of an alignment procedure (e.g., data regarding a recipient's coupling) can be stored (e.g., recorded) to inform the recipient's healthcare provider, compared with such data for other recipients, and used to generate guidance (e.g., recommendations) for improving the recipient's link integrity and efficiency and / or changing the recipient's care (e.g., by acting on a recommendation for clinical intervention).

[0071] Figure 8 is a flow chart of an exemplary method 800 according to certain embodiments described herein. Figure 2 , 3A -3C and 4 of the exemplary device 200 structure to describe method 800, but other devices and systems with other configurations of components can also be used to perform method 800 according to certain embodiments described herein. For example, some or each of the operation blocks of method 800 can be performed using an external device configured to be operatively coupled to an implanted device, and / or some or each of the operation blocks of method 800 can be performed using a separate device that wirelessly communicates with an external device (e.g., a device including a viewing screen; a smart phone; a smart tablet; a smart watch; or other remote device).

[0072] In operation block 810, method 800 includes receiving at least one first measurement of inductive coupling between an external device (e.g., component 202) external to a recipient's body and an internal device (e.g., implanted device 300) within the recipient's body. For example, while a user (e.g., recipient; practitioner) is positioning component 202 over implanted device 300, third circuit system 230 may obtain a first measurement of at least one parameter (e.g., indicating inductive coupling between component 202 and implanted device 300).

[0073] In operation block 820, method 800 also includes accessing data corresponding to a second measurement of inductive coupling between other external devices outside the bodies of other recipients and other internal devices within the bodies of other recipients. For example, this data may be stored at a central database and accessed by communication via the Internet (e.g., by an external device or a separate device operated by a user). This data may provide a baseline for optimal positioning derived from experience with other recipients having the same or similar characteristics as the recipient (e.g., type of implanted device; flap thickness or SFT). In operation block 830, method 800 also includes comparing the first measurement with the second measurement. For example, the second measurement may correspond to the optimal coupling strength of other recipients, and the comparison may use the second measurement as a baseline for placing the external device (e.g., the optimal coupling strength to be achieved by the recipient). In operation block 840, method 800 also includes generating an assessment of the inductive coupling between the external device and the recipient's internal device in response to the comparison. For example, when the comparison indicates that the inductive coupling between the recipient's external device and the internal device is outside of an acceptable range compared to a baseline, the evaluation may include guidance information to be generated, and this guidance information may be provided to the user to facilitate proper positioning of the external device.

[0074] Fig. 9 is a flow chart of another exemplary method 900 according to certain embodiments described herein. Figure 2 , 3A -3C and 4 of the exemplary device 200 structure to describe method 900, but other devices and systems with other configurations of components can also be used to perform method 900 according to certain embodiments described herein. For example, some or each of the operational blocks of method 900 can be performed using an external device configured to be operatively coupled to an implanted device, and / or some or each of the operational blocks of method 900 can be performed using a separate device that wirelessly communicates with an external device (e.g., a device including a viewing screen; a smart phone; a smart tablet; a smart watch; or other remote device).

[0075] In operation block 910, method 900 includes placing an external component (e.g., component) 202 of a medical device on the skin 150 of a recipient such that only one of the two magnetic poles of the external component covers a corresponding one of the two magnetic poles of an internal component of the medical device implanted in the recipient's body (e.g., implanted device 300).

[0076] At operation block 920, method 900 further includes receiving one or more prompts from the medical device to adjust placement of the external component on the recipient's skin until both magnetic poles of the external component overlap both corresponding magnetic poles of the internal component. In some embodiments, the one or more prompts are based on one or more measurements of inductive coupling between the external component and the internal component (e.g., between the first circuit system 210 and the second circuit system 320).

[0077] In some embodiments, having both magnetic poles of the external component overlying both corresponding magnetic poles of the internal component generates a first retention force, the first retention force being configured to retain the external component on the recipient's skin. In some embodiments, having only one of the two magnetic poles of the external component overlying a corresponding one of the two magnetic poles of the internal component generates a second retention force, the second retention force being less than the first retention force.

[0078] Although for ease of understanding, common terms are used to describe the systems and methods of certain embodiments, these terms are used herein to have their broadest reasonable interpretation. Although various aspects of the present disclosure are described with respect to illustrative examples and embodiments, the disclosed examples and embodiments should not be interpreted as restrictive. Unless otherwise specifically stated, or otherwise understood in the context as used, conditional language such as "can", "could", "might" or "may" is generally intended to convey that a particular embodiment includes specific features, elements and / or steps, while other embodiments do not include specific features, elements and / or steps. Therefore, such conditional language is generally not intended to imply that features, elements and / or steps are required in any way for one or more embodiments, or is not intended to imply that one or more embodiments must include logic for determining whether these features, elements and / or steps are included in any particular embodiment or will be executed in any particular embodiment with or without user input or prompts. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components or steps in a non-exclusive manner, indicating that the referenced elements, components or steps may exist or utilize or be combined with other elements, components or steps that are not explicitly referenced.

[0079] It should be appreciated that the embodiments disclosed herein are not mutually exclusive and may be combined with one another in various arrangements. Additionally, while the disclosed methods and apparatus are largely described in the context of conventional cochlear implants, the various embodiments described herein may be incorporated into a variety of other suitable devices, methods, and contexts. More generally, as may be appreciated, certain embodiments described herein may be used in a variety of implantable medical device contexts that may benefit from enabling wireless communication between the implanted device and an external device.

[0080] As used herein, degree language such as the terms "approximately," "about," "substantially," and "substantially" represent values, quantities, or features that are close to the stated value, quantity, or feature that still performs the desired function or achieves the desired result. For example, the terms "approximately," "about," "substantially," and "substantially" may refer to an amount within ±10% of the stated amount, within ±5% of the stated amount, within ±2% of the stated amount, within ±1% of the stated amount, or within ±0.1% of the stated amount. As another example, the terms "substantially parallel" and "substantially parallel" refer to a value, quantity, or feature that deviates from exact parallelism by ±10 degrees, ±5 degrees, ±2 degrees, ±1 degrees, or ±0.1 degrees, and the terms "substantially perpendicular" and "substantially perpendicular" refer to a value, quantity, or feature that deviates from exact perpendicularity by ±10 degrees, ±5 degrees, ±2 degrees, ±1 degrees, or ±0.1 degrees. The ranges disclosed herein also encompass any and all overlaps, subranges, and combinations thereof. Language such as "up to," "at least," "greater than," "less than," "between," and the like include the recited numbers. As used herein, the meanings of "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Additionally, as used in the description herein, the meaning of "in" includes "into" and "on," unless the context clearly dictates otherwise.

[0081] Although methods and systems are discussed herein in terms of elements labeled by ordinal adjectives (e.g., first, second, etc.), the ordinal adjectives are merely used as labels to distinguish one element from another (e.g., one signal from another signal, or one circuit from another circuit), and the ordinal adjectives are not used to indicate the order of these elements or their order of use.

[0082] The invention described and claimed herein is not limited in scope by the specific example embodiments disclosed herein, because these embodiments are intended to be illustrative of several aspects of the present invention, rather than limiting. Any equivalent embodiments are intended to be within the scope of the present invention. In fact, various modifications of the present invention in form and detail will become apparent to those skilled in the art from the foregoing description, in addition to those shown and described herein. Such modifications are also intended to fall within the scope of the claims. The breadth and scope of the present invention should not be limited by any of the example embodiments disclosed herein, but should only be defined according to the claims and their equivalents.

Claims

1. A device comprising: a component configured to be placed over a portion of a recipient's skin that overlies the implanted device; a first circuit system within the component, the first circuit system being configured to wirelessly communicate with a second circuit system within the implanted device, the first circuit system having a set of optimal operating positions relative to the second circuit system; as well as A third circuit system is configured to detect at least one parameter indicative of displacement of the first circuit system from the set of optimal operating positions and to generate at least one signal indicative of a magnitude and / or direction for moving the first circuit system toward the set of optimal operating positions.

2. A device according to claim 1, wherein the device further comprises at least one first magnet, which is mounted within the component and is configured to generate a magnetic attraction with at least one second magnet within the implanted device, the magnetic attraction being configured to hold the component on the skin portion, wherein the first circuit system is in the set of optimal operating positions.

3. A device according to claim 2, wherein the at least one first magnet includes a first magnetic moment extending substantially parallel to the skin portion when the first circuit system is in the set of optimal operating positions, and the at least one second magnet includes a second magnetic moment extending substantially parallel to the skin portion and is configured to rotate in a plane substantially parallel to the skin portion.

4. Apparatus according to claim 2 or claim 3, wherein the at least one second magnet comprises a radial magnet.

5. The device according to any one of claims 2 to 4, wherein the at least one parameter comprises the magnetic field strength of the magnetic attraction force.

6. An apparatus as claimed in any preceding claim, wherein the at least one parameter is indicative of efficiency and / or data integrity of communications between the first circuitry and the second circuitry.

7. The apparatus of any preceding claim, wherein the first circuit system comprises a first inductive communication coil and the second circuit system comprises a second inductive communication coil, the first inductive communication coil being configured to inductively communicate with the second inductive communication coil.

8. The apparatus of claim 7, wherein the at least one parameter comprises a mutual inductance of the first inductive communication coil and the second inductive communication coil.

9. An apparatus according to any preceding claim, wherein the at least one parameter is selected from the group consisting of: the number of communication errors or the communication error rate between the first circuit system and the second circuit system; the communication power consumption rate between the first circuit system and the second circuit system; the voltage or attenuation rate received by the implanted device.

10. An apparatus according to any preceding claim, further comprising a user interface configured to generate audio, visual or tactile indicia in response to the at least one signal to communicate the magnitude and / or direction to a user.

11. An apparatus according to any one of claims 1 to 9, wherein the third circuit system is within the component and / or the implanted device and is configured to wirelessly transmit the at least one signal to a communication device separate from the apparatus, the communication device being configured to generate audio, visual and / or tactile markings in response to the at least one signal to convey the magnitude and / or direction to a user.

12. An apparatus according to any one of claims 1 to 10, wherein the third circuit system is in a device separate from both the component and the implanted device.

13. An apparatus according to any preceding claim, wherein the third circuit system is configured to compare the measured value of the at least one parameter with a set of optimal operating values ​​of the at least one parameter, the set of optimal operating values ​​of the at least one parameter corresponding to the set of optimal operating positions of the first circuit system relative to the second circuit system.

14. An apparatus according to claim 13, wherein the third circuit system includes a storage circuit system, which is configured to contain data relating the measured value of the at least one parameter to a corresponding magnitude and / or direction for moving the first circuit system toward the set of optimal operating positions.

15. Apparatus according to any preceding claim, wherein the component comprises an external part of a hearing prosthesis system and the implanted device comprises an internal part of the hearing prosthesis system.

16. A method comprising: prompting a user to sequentially position an external device external to a recipient's body at a series of positions relative to an internal device within the recipient's body, the external device comprising at least one external communications coil and the internal device comprising at least one internal communications coil; receiving data indicative of measured coupling values ​​between the at least one external communication coil and the at least one internal communication coil, the measured coupling values ​​being measured with the at least one external communication coil located at different locations in the series of locations; as well as An optimal position of the external device is determined, the optimal position corresponding to a maximum coupling value obtained using the measured coupling values.

17. The method of claim 16, further comprising triggering the prompt when the external device is moved from a first position having a coupling value less than a predetermined threshold to a second position having a coupling value greater than the predetermined threshold.

18. The method of claim 16, further comprising triggering the prompt when a wireless communication link is established or re-established between the external device and the internal device.

19. The method of claim 16, further comprising triggering the prompt upon receiving an input signal from the user.

20. The method of any one of claims 16 to 19, wherein the external device comprises a sound processor of a hearing prosthesis system and the internal device comprises an implanted stimulation component of the hearing prosthesis system.

21. A method comprising: receiving at least one first measurement of inductive coupling between an external device external to a recipient's body and an internal device within the recipient's body; accessing data corresponding to a second measurement of inductive coupling between another external device external to another recipient's body and another internal device within the body of the other recipient; comparing the first measurement value to the second measurement value; as well as In response to the comparison, an assessment of the inductive coupling between the external device and the internal device is generated.

22. The method of claim 21, wherein said accessing said data comprises accessing a database by communicating via the Internet.

23. A method according to claim 21 or claim 22, wherein the comparing comprises using the second measurement as a baseline for placement of the external device.

24. A method according to any one of claims 21 to 23, wherein the assessment includes guidance information to be provided to a user to facilitate positioning of the external device.

25. A system comprising: a component having an outer surface portion configured to be placed over a portion of a recipient's skin that overlies the implanted device; a first magnet within the component, the first magnet comprising a first substantially planar magnetic surface, the first substantially planar magnetic surface being configured to be substantially parallel to the skin portion and having a first north magnetic pole region and a first south magnetic pole region, the implanted device comprising a second magnet having a second substantially planar magnetic surface, the second substantially planar magnetic surface being substantially parallel to the skin portion and having a second north magnetic pole region and a second south magnetic pole region; as well as Circuitry is configured to detect a configuration of the first magnet and the second magnet when the component is at least partially positioned over the implanted device and to generate at least one signal indicative of the configuration.

26. The system of claim 25, wherein the first substantially planar magnetic surface has a single first north magnetic pole region and a single first south magnetic pole region, and the second substantially planar magnetic surface has a single second north magnetic pole region and a single second south magnetic pole region.

27. A system according to claim 25 or claim 26, wherein the first magnet comprises a single first north pole and a single south pole.

28. A system according to any one of claims 25 to 27, wherein the circuit system is configured to distinguish between a first configuration and a second configuration, wherein the first configuration causes both the first north magnetic pole region and the first south magnetic pole region to overlap with both the second south magnetic pole region and the second north magnetic pole region, and the second configuration causes one of the first north magnetic pole region and the first south magnetic pole region to overlap with one of the second south magnetic pole region and the second north magnetic pole region, and the other of the first north magnetic pole region and the first south magnetic pole region does not overlap with the other of the second south magnetic pole region and the second north magnetic pole region.

29. A system according to any one of claims 25 to 28, wherein the circuit system is configured to distinguish between a first configuration and a second configuration, wherein the first configuration causes each of the second south magnetic pole region and the second north magnetic pole region to be directly below the relative poles of the first north magnetic pole region and the first south magnetic pole region, and the second configuration causes only one of the second south magnetic pole region and the second north magnetic pole region to be directly below the relative poles of the first north magnetic pole region and the first south magnetic pole region.

30. An apparatus according to any one of claims 25 to 29, wherein the first magnet is fixed within the component and the second magnet is configured to rotate freely in a plane substantially parallel to the skin portion while remaining within the implanted device.

31. A method comprising: placing an external component of a medical device on the skin of a recipient such that only one of the two magnetic poles of the external component overlies a corresponding one of the two magnetic poles of an internal component of the medical device implanted in the recipient; as well as One or more prompts are received from the medical device to adjust placement of the external component on the skin of the recipient until both of the two magnetic poles of the external component overlie both of the corresponding two magnetic poles of the inner component.

32. The method of claim 31, wherein causing both of the two magnetic poles of the external component to overlap both of the corresponding two magnetic poles of the internal component generates a first retaining force configured to retain the external component on the skin of the recipient.

33. The method of claim 32, wherein causing only one of the two magnetic poles of the outer member to overlie the corresponding one of the two magnetic poles of the inner member generates a second retaining force, the second retaining force being less than the first retaining force.

34. A method according to any one of claims 31 to 33, wherein the one or more prompts are based on one or more measurements of inductive coupling between the external component and the internal component.

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