External portion of medical implant with compliant skin contacting surface

Abstract

A device includes: a housing configured to be worn on a body of a recipient; circuitry housed within the housing, the circuitry configured to wirelessly communicate with an implanted device within a body of the recipient; and at least one magnet housed within the housing and configured to interact with the implant device to generate an attractive magnetic force configured to retain the housing on the recipient's body. The apparatus also includes a concave and resilient portion configured to contact the recipient's body when the housing is held on the recipient's body by the magnetic force. The portion is configured to flex in response to being pressed against the recipient's body by the magnetic force.

Description

background Technical Field

[0001] The present application generally relates to systems and methods for positioning an external portion of a medical device implanted on or within the body of a recipient. Background Art

[0002] Medical devices have provided a wide range of therapeutic benefits to recipients over the last several decades. Medical devices may include internal or implantable components / devices, external or wearable components / devices, or combinations thereof (e.g., a device having an external component that communicates with an implantable component). Medical devices, such as traditional hearing aids, partially or fully implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful over the years in performing life-saving and / or lifestyle-improving functions and / or recipient monitoring.

[0003] Over the years, the types of medical devices and the range of functions performed by them have increased. For example, many medical devices, sometimes referred to as "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 body of a recipient. 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 component. Summary of the invention

[0004] In one aspect disclosed herein, a device includes a housing configured to be worn on a recipient's body. The device also includes a circuit system contained within the housing. The circuit system is configured to wirelessly communicate with an implanted device within the recipient's body. The device also includes at least one magnet contained within the housing. The at least one magnet is configured to interact with the implanted device to generate an attractive magnetic force configured to hold the housing on the recipient's body. The device also includes a concave and elastic portion configured to contact the recipient's body when the housing is held on the recipient's body by the magnetic force. The portion is configured to flex in response to being pressed against the recipient's body by the magnetic force.

[0005] In another aspect disclosed herein, a method includes providing a first device configured to be worn on a recipient's skin over a second device implanted beneath the recipient's skin. The first device includes a compliant housing portion configured to contact the recipient's skin. The method also includes magnetically retaining the first device over the second device, wherein the compliant housing portion is pressed against the recipient's skin. The method also includes increasing a contact area of ​​the compliant housing portion pressed against the recipient's skin.

[0006] In another aspect disclosed herein, a device includes: at least one external magnet configured to be held to a recipient's scalp by an attractive magnetic force between the at least one external magnet and at least one internal magnetic material of an implant device beneath the recipient's scalp. The device also includes at least one external radio frequency (RF) coil configured to wirelessly communicate with at least one internal RF coil of the implant device. The device also includes a housing portion, the housing portion including at least one flexible material configured to contact the recipient's scalp. The housing portion includes a surface configured to substantially conform to the curvature of the recipient's scalp in response to being pressed against the recipient's scalp by the attractive magnetic force.

[0007] In another aspect disclosed herein, an apparatus includes: at least one external device configured to be held on a recipient's skin over at least one internal device beneath the recipient's skin by an attractive force between the at least one external device and the at least one internal device. The at least one external device includes an elastic wall having a surface configured to contact the recipient's skin in response to being pressed against the recipient's skin by the attractive force, substantially conform to the curvature of the recipient's skin, and generate a restoring force pressed against the recipient's skin. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Embodiments are described herein with reference to the accompanying drawings, in which:

[0009] Figure 1A is a perspective view of an example cochlear implant hearing prosthesis implanted in a recipient according to certain embodiments described herein;

[0010] Figure 1B is a perspective view of an example fully implantable middle ear implant hearing prosthesis implanted in a recipient according to certain embodiments described herein;

[0011] Figure 2Aschematically illustrates a cross-sectional view of an example transcutaneous system including an example device spaced apart from a recipient's body according to certain embodiments described herein;

[0012] Figure 2B Schematic diagram of a method of contacting a recipient's body according to some embodiments described herein. Figure 2A A cross-sectional view of an example transdermal system of an example device;

[0013] Figure 3A and 3B schematically illustrates two example devices in which the housing includes the described parts according to some embodiments described herein; and

[0014] Figure 4 is a flow chart of an example method according to certain implementations described herein. DETAILED DESCRIPTION

[0015] Certain embodiments described herein provide an external portion of a medical device (e.g., an off-ear sound processor of an auditory prosthesis) that is configured to be worn in contact with the skin of a recipient. The external portion has a concave surface that is configured to contact the outer surface of the skin of the recipient and to flex elastically in response to the magnetic attraction force that holds the external portion against the skin. By flexing, the surface can conform to the curvature of the body (e.g., head) of the recipient, thereby increasing the contact surface area to reduce the pressure of a given holding force, and the holding force is more evenly distributed on the contact surface area, both of which improve the comfort of the recipient. This improved comfort allows the recipient to withstand a wider range of holding forces, thereby allowing the superposition of the magnet strength that is used to hold the external portion against the skin. In addition, by flexing, the surface can increase the translational friction between the skin of the external portion and the recipient, thereby reducing the risk of accidental displacement of the external portion from the skin of the recipient.

[0016] The teachings detailed herein are applicable, in at least some embodiments, to any type of implantable or non-implantable stimulation system or device (e.g., an implantable or non-implantable hearing prosthetic device or system). Embodiments may include any type of medical device that may utilize the teachings detailed herein and / or variations thereof. Furthermore, while certain embodiments are described herein in the context of hearing prosthetic devices, certain other embodiments are compatible in the context of other types of devices or systems (e.g., smartphones; smart speakers).

[0017] For ease of description only, the apparatus and methods disclosed herein are described primarily with reference to exemplary medical devices, i.e., implantable transducer assemblies, 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; transcutaneous bone conduction devices; percutaneous bone conduction devices), direct acoustic cochlear implants (DACIs), middle ear transducers (METs), electro-acoustic implant devices, other types of hearing prosthesis devices, and / or combinations or variations thereof, or any other suitable hearing prosthesis systems with or without one or more external components. Implementations may include any type of hearing prosthesis capable of utilizing the teachings detailed herein and / or variations thereof. Certain such implementations may be referred to as "partially implantable," "semi-implantable," "mostly implantable," "fully implantable," or "completely implantable" hearing prostheses. In some implementations, the teachings detailed herein and / or variations thereof may be utilized in other types of prostheses besides hearing prostheses.

[0018] Figure 1A is a perspective view of an example cochlear implant hearing prosthesis 100 implanted in a recipient according to certain embodiments described herein. Figure 1A 1 and 12. The example hearing prosthesis 100 (e.g., a fully implantable cochlear implant; a mostly implantable cochlear implant) according to certain embodiments described herein may be replaced with a subcutaneously implantable microphone assembly as described more fully herein. Figure 1A In some embodiments, the external microphone assembly 124 is shown in FIG. Figure 1A The example cochlear implant hearing prosthesis 100 may be combined with a liquid medicament reservoir as described herein.

[0019] like Figure 1AAs shown in FIG. 1 , the recipient has an outer ear 101, a middle ear 105, and an inner ear 107. In a fully functional ear, the outer ear 101 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 the oval window or ovate window 112 through three bones of the middle ear 105, which are collectively referred to as the ossicles 106 and include the malleus 108, the incus 109, and the stapes 111. The bones 108, 109, and 111 of the middle ear 105 serve to filter and amplify the sound 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.

[0020] like Figure 1A As shown in FIG, the example hearing prosthesis 100 includes one or more components that are temporarily or permanently implanted in a recipient. Figure 1A 1 is shown as having: an external component 142 that is directly or indirectly attached to the recipient's body; 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 sound input elements (e.g., an external microphone 124) for detecting sound, a sound processing unit 126 (e.g., disposed in a behind-the-ear unit), a power source (not shown), and an external transmitter unit 128. Figure 1A In the exemplary embodiment of the invention, the external transmitter unit 128 includes an external coil 130 (e.g., a wire antenna coil including multiple turns of electrically insulated single or multiple strands of platinum or gold wire), and preferably includes a magnet (not shown) directly or indirectly secured to the external coil 130. The external coil 130 of the external transmitter unit 128 is part of an inductive radio frequency (RF) communication link with the internal component 144. The sound processing unit 126 processes the output of the microphone 124, which in the depicted embodiment is positioned outside the recipient's body by the recipient's pinna 110. The sound processing unit 126 processes the output of the microphone 124 and generates an encoded signal, sometimes referred to herein as an encoded data signal, which is provided to the external transmitter unit 128 (e.g., via a cable). 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.

[0021] 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 transcutaneous energy transfer link). The transcutaneous 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.

[0022] The internal component 144 includes an internal receiver unit 132, a stimulator unit 120, and an elongated electrode assembly 118. In some embodiments, the internal receiver unit 132 and the stimulator unit 120 are hermetically sealed in a biocompatible housing. The internal receiver unit 132 includes an internal coil 136 (e.g., a wire antenna coil including multiple turns of electrically insulating single or multiple strands of platinum or gold wire), and preferably includes a magnet (also not shown) fixed relative to the internal coil 136. The internal receiver unit 132 and the stimulator unit 120 are hermetically sealed in a biocompatible housing, which is sometimes collectively referred to as a stimulator / receiver unit. The internal coil 136 receives power and / or data signals from the external coil 130 via a transcutaneous energy transfer link (e.g., an inductive RF link). 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.

[0023] 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 deeper. For example, the electrode assembly 118 can extend toward the top of the cochlea 140 (referred to as 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 a circular window 121, an oval window 112, a promontory 123, or by the apical turn 147 of the cochlea 140.

[0024] The elongated electrode assembly 118 includes a longitudinally aligned and distally extending array 146 of electrodes or contacts 148 disposed along its length, sometimes referred to herein as the 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 that are applied by the electrodes 148 to the cochlea 140, thereby stimulating the auditory nerve 114.

[0025] Although Figure 1A The hearing prosthesis 100 is schematically illustrated as utilizing an external component 142 including an external microphone 124, an external sound processing unit 126, and an external power source, but in certain other embodiments, one or more of the microphone 124, the sound processing unit 126, and the power source may be implantable on or in a recipient (e.g., within the internal component 144). For example, the hearing prosthesis 100 may have each of the microphone 124, the sound processing unit 126, and the power source implantable on or in a recipient (e.g., enclosed within a biocompatible component located subcutaneously), and may be referred to as a totally implantable cochlear implant ("TICI"). As another example, the hearing prosthesis 100 may have most of the components of a cochlear implant implantable on or in a recipient (e.g., excluding the microphone, which may be an in-ear canal microphone), and may be referred to as a mostly implantable cochlear implant ("MICI").

[0026] Figure 1B Schematically depicts a perspective view of an example fully implantable hearing prosthesis 200 (eg, a fully implantable middle ear implant or a fully implantable acoustic system) implanted in a recipient utilizing an acoustic actuator in accordance with certain embodiments described herein. Figure 1B The example hearing prosthesis 200 includes a biocompatible implantable component 202 (eg, including an implantable capsule) located subcutaneously (eg, beneath the skin of a recipient and on the skull of the recipient). Figure 1BAn example implantable component 202 including a microphone is schematically shown, but in other example hearing prostheses 200, a pendant microphone (e.g., connected to the implantable component 202 by a cable) may be used. The implantable component 202 includes a signal receiver 204 (e.g., including a coil element) and an acoustic transducer 206 (e.g., a microphone including a diaphragm and an electret or piezoelectric transducer) that is positioned to receive acoustic signals through the recipient's overlying tissue. The implantable component 202 can also be used to accommodate multiple components of the entire implantable hearing prosthesis 200. For example, the implantable component 202 can include an energy storage device and a signal processor (e.g., a sound processing unit). Various additional processing logic and / or circuit system components can also be included in the implantable component 202 as a design choice.

[0027] for Figure 1B In the example hearing prosthesis 200 shown in FIG. 1 , a signal processor of an implantable component 202 is in operative communication (e.g., electrically interconnected via a wire 208 ) with an actuator 210 (e.g., including a transducer configured to generate mechanical vibrations in response to an electrical signal from the signal processor). In some embodiments, Figure 1A and 1B The example hearing prosthesis 100, 200 shown in FIG. 1 may include an implantable microphone assembly such as Figure 1B 100. For such example hearing prosthesis 100, the signal processor of implantable component 202 can be in operative communication (e.g., electrically interconnected via wires) with microphone component 206 and a stimulator unit of main implantable component 120. In some embodiments, at least one of microphone component 206 and the signal processor (e.g., a sound processing unit) is implanted on or in the recipient.

[0028] Figure 1B The actuator 210 of the example hearing prosthesis 200 shown in FIG. 1 is supportably connected to a positioning system 212, which in turn is connected to a bone anchor 214 installed in the mastoid of a recipient (e.g., via a hole drilled through the skull). The actuator 210 includes a connection device 216 for connecting the actuator 210 to the ossicles 106 of the recipient. In a connected state, the connection device 216 provides a communication path for acoustic stimulation of the ossicles 106 (e.g., by transmitting vibrations from the actuator 210 to the incus 109).

[0029] During normal operation, an ambient acoustic signal (e.g., ambient sound) impinges on the recipient's tissue and is received transcutaneously at the microphone assembly 206. Upon receiving the transcutaneous signal, a signal processor within the implantable assembly 202 processes the signal to provide a processed audio drive signal to the actuator 210 via the wire 208. It will be appreciated that the signal processor can utilize digital processing techniques to provide frequency shaping, amplification, compression, and other signal adjustments, including adjustments based on recipient-specific fitting parameters. The audio drive signal causes the actuator 210 to transmit an acoustic frequency vibration to the connection device 216 to affect a desired sound sensation via mechanical stimulation of the recipient's incus 109.

[0030] The subcutaneously implantable microphone assembly 202 is configured to respond to auditory signals (e.g., sound; pressure changes in the audible frequency range) by generating output signals (e.g., electrical signals; optical signals; electromagnetic signals) that are indicative of the auditory signals received by the microphone assembly 202, and these output signals are used by the hearing prosthesis 100, 200 to generate stimulation signals that are provided to the recipient's auditory system. In order to compensate for the reduced acoustic signal strength reaching the microphone assembly 202 due to implantation, the diaphragm of the implantable microphone assembly 202 can be configured to provide a higher sensitivity than an external non-implantable microphone assembly. For example, the diaphragm of the implantable microphone assembly 202 can be configured to be stronger and / or larger than a diaphragm used for an external non-implantable microphone assembly.

[0031] Figure 1A The example hearing prosthesis 100 shown in FIG. 1 utilizes an external microphone 124 , Figure 1B The hearing prosthesis 200 shown in the drawings utilizes an implantable microphone assembly 206 that includes a subcutaneously implantable acoustic transducer. In certain embodiments described herein, the hearing prosthesis 100 utilizes one or more implantable microphone assemblies on or in a recipient. In certain embodiments described herein, the hearing prosthesis 200 utilizes one or more microphone assemblies positioned external to and / or implanted on or in a recipient, and utilizes one or more acoustic transducers (e.g., actuator 210) implanted on or in a recipient. In certain embodiments, an external microphone assembly may be used to supplement the implantable microphone assembly of the hearing prosthesis 100, 200. Thus, the teachings detailed herein and / or variations thereof may be used with any type of external or implantable microphone arrangement, and Figure 1A and 1B The acoustic transducers shown in are exemplary only.

[0032] Figure 2ASchematically illustrated is a cross-sectional view of an example transcutaneous system 300 including an example device 330 spaced apart from a recipient's body, according to certain embodiments described herein. Figure 2B Schematic diagram of a method of contacting a recipient's body according to some embodiments described herein. Figure 2A 20 is a cross-sectional view of an example transcutaneous system 300 of an example device 330. The example transcutaneous system 300 includes an implantable device 310 within the body of a recipient and a device 330 external to the body of the recipient. For example, the transcutaneous system 300 may include a hearing prosthesis system in which the implantable device 310 includes one or more active elements (e.g., stimulator unit 120; component 202; vibration actuator) configured to deliver stimulation to the body of the recipient.

[0033] The implantable device 310 includes at least one implantable housing 312 configured to be positioned beneath tissue of a recipient's body. Figure 2A and 2B , at least one implantable housing 312 is shown in a portion of a recipient's body (e.g., head) below a skin layer 320, a fat layer 322, and / or a muscle layer 324 (e.g., scalp) and above a bone 326 (e.g., skull). The at least one implantable housing 312 contains at least one internal energy receiving coil 314 (e.g., a substantially planar conductive wire having a plurality of windings) and at least one internal magnetic (e.g., ferromagnetic; ferrimagnetic; permanent magnet) material 316 (e.g., disk; plate) positioned within an area at least partially defined by the at least one internal energy receiving coil 314. The at least one internal magnetic material 316 may include a diamagnetic magnet configured to be compatible with magnetic resonance imaging of the recipient. The at least one internal magnetic material 316 is configured to establish magnetic attraction between the device 330 and the implantable device 310 sufficient to hold the device 330 against an outer surface 321 of the skin 320. At least one implantable housing 312 may include a first portion and a second portion, wherein the first portion is configured to contain at least one internal energy receiving coil 314 and at least one internal magnetic material 316, and the second portion is configured to contain one or more active elements, or at least one implantable housing 312 may include a single housing portion, wherein the single housing portion is configured to contain at least one internal energy receiving coil 314, at least one internal magnetic material 316, and one or more active elements.

[0034] In some embodiments, the device 330 includes a housing 332 configured to be worn on the body of a recipient and a circuit system 334 contained within the housing 332. The circuit system 334 is configured to wirelessly communicate with the implant device 310 within the body of the recipient. The device 330 also includes at least one magnet 336 contained within the housing 332. The at least one magnet 336 is configured to interact with the implant device 310 to generate an attractive magnetic force 338 configured to hold the housing 332 on the body of the recipient. The device 330 also includes a concave (e.g., inwardly curved) and elastic (e.g., flexible; springy) portion 340 that is configured to contact the body of the recipient when the housing 332 is held on the body of the recipient by a magnetic force. The portion 340 is configured to flex in response to being pressed against the body of the recipient by the magnetic force 338.

[0035] In some embodiments, the housing 332 of the device 330 is configured to be positioned on and / or over the outer surface 321 of the skin 320 and to hermetically seal the circuit system 334 and / or the at least one magnet 336 from the environment surrounding the housing 332. The housing 332 can have a width (e.g., along a lateral direction substantially parallel to the recipient's skin 320) of less than or equal to 40 mm (e.g., in a range of 15 mm to 35 mm; in a range of 25 mm to 35 mm; in a range of less than 30 mm; in a range of 15 mm to 30 mm). The housing 422 can have a thickness (e.g., in a direction substantially perpendicular to the recipient's skin 320) of less than or equal to 10 mm (e.g., in a range of less than or equal to 7 mm; in a range of less than or equal to 6 mm; in a range of less than or equal to 5 mm).

[0036] In some embodiments, the circuit system 334 of the device 330 includes at least one energy transmission coil 335 (e.g., a substantially planar conductive wire coil having multiple windings of electrically insulated single or multi-strand copper wire; copper traces on epoxy resin of a printed circuit board; having a substantially circular, rectangular, spiral or oval shape or other shape). The at least one energy transmission coil 335 can have a diameter, length, and / or width (e.g., along a lateral direction substantially parallel to the recipient's skin 320) of less than or equal to 40 mm (e.g., in the range of 15 mm to 35 mm; in the range of 25 mm to 35 mm; in the range of less than 30 mm; in the range of 15 mm to 30 mm). In some embodiments, the at least one energy transmission coil 335 can be sufficiently flexible to flex in response to flexing of the portion 340, while in some other embodiments, the at least one energy transmission coil 335 is substantially rigid so as not to flex in response to flexing of the portion 340. In some embodiments, the at least one energy transmission coil 335 is within the concave and elastic portion 340.

[0037] In some embodiments, the circuit system 334 is configured to wirelessly communicate (e.g., via a radio frequency or RF link; via a magnetic induction link) with at least one internal energy receiving coil 314 when the device 330 is positioned on the recipient's skin 320 above the implant device 310 (e.g., the device 330 is held in place by a magnetic attraction 338 between at least one internal magnetic material 316 and at least one magnet 336). For example, at least one energy transmission coil 335 of the circuit system 334 can be inductively coupled to at least one internal energy receiving coil 314 and configured to wirelessly transmit electrical power to at least one internal energy receiving coil 314 and / or to wirelessly transmit information (e.g., data signals; control signals) to at least one internal energy receiving coil 314 and / or to wirelessly receive information from at least one internal energy receiving coil.

[0038] In some embodiments, the circuit system 334 also includes one or more microprocessors (e.g., application specific integrated circuits; general purpose integrated circuits programmed by software with computer executable instructions; microelectronic circuit systems; microcontrollers) configured to control the operation of the device 330 and / or implant device 310 (e.g., setting or adjusting parameters of energy delivery in response to user input and / or conditions during operation). In some embodiments, the circuit system 334 also includes at least one storage device (e.g., at least one tangible or non-transitory computer readable storage medium; read-only memory; random access memory; flash memory) in operative communication with the one or more microprocessors. The at least one storage device can be configured to store information (e.g., data; commands) accessed by the one or more microprocessors during operation. The at least one storage device can be encoded with software (e.g., a computer program downloaded as an application) that includes computer executable instructions for instructing the one or more microprocessors (e.g., executable data access logic, evaluation logic, and / or information output logic). In some embodiments, the one or more microprocessors execute the instructions of the software to provide functionality as described herein. In certain embodiments, the circuit system 334 also includes at least one energy storage device (eg, battery; capacitor) configured to provide energy to other components of the device 330 .

[0039] In certain embodiments, at least one magnet 336 comprises a ferromagnetic material, a ferrimagnetic material, and / or a permanent magnet (eg, a disk; a plate) positioned within the housing 332. Figure 2A and 2BSchematically illustrated, at least one magnet 336 can be within an area at least partially defined by at least one energy transfer coil 335 of the circuit system 334 and can extend above the substantially planar energy transfer coil 335. The at least one magnet 336 can be substantially centrally located relative to the housing 332 and / or substantially concentric with the at least one energy transfer coil 335 (e.g., centered above the at least one energy transfer coil).

[0040] In certain embodiments, at least one magnet 336 is configured to establish a magnetic attraction force 338 between the device 330 and the implant device 310 (e.g., to generate a magnetic attraction force 338 with at least one internal magnetic material 316 of the implant device 310) sufficient to hold the device 330 on the body of the recipient (e.g., the outer surface 342 of the portion 340 is pressed against the outer surface 321 of the skin 330). In order to generate a sufficiently strong magnetic attraction, the at least one magnet 336 can be positioned as close as possible to the surface 342 that contacts the skin 320 of the recipient, thereby minimizing the distance between the at least one magnet 336 and the at least one internal magnetic material 316. The attractive magnetic force 338 extends in a direction substantially perpendicular to the portion 340 (e.g., substantially perpendicular to the outer surface 342; substantially perpendicular to the skin 320 of the recipient).

[0041] Figure 3A and 3B Two example devices 330 are schematically shown in which the housing 332 includes a portion 340 according to certain embodiments described herein. For example, the housing 332 may include an upper portion 350 that is mechanically coupled to the portion 340 that includes the lower wall of the housing 332. The portion 340 and the upper portion 350 may be hermetically sealed to each other so that both the portion 340 and the upper portion 350 define an area that accommodates the circuit system 334 and the at least one magnet 336. Since the portion 340 contacts the body of the recipient, the portion 340 may include at least one biocompatible (e.g., skin-friendly) material. In addition, since the portion 340 is positioned between the circuit system 334 and the implant device 310, the portion 340 may be substantially transmissive to the electromagnetic field or magnetic field generated by the circuit system 334 and / or the at least one magnet 336, so that the housing 332 does not substantially interfere with the transmission of power via magnetic induction and / or attractive magnetic forces 338 between the device 330 and the implant device 310. Examples of biocompatible and substantially transmissive materials include, but are not limited to: polymers; rubber; silicone. Since the upper portion 350 does not contact the recipient's body, the upper portion 350 may include at least one rigid material, such as Figure 3A and 3B Examples of rigid materials compatible with certain embodiments described herein include, but are not limited to: metals, plastics, ceramics.

[0042] In some embodiments, portion 340 includes an outer surface 342 configured to contact the body of a recipient. Surface 342 can be configured to flex in response to being pressed against an outer surface 321 (e.g., scalp) of the recipient's skin 320 by a magnetic force 338 between at least one magnet 336 and at least one internal magnetic material 316. Figure 3A Schematically shown, portion 340 is substantially homogeneous and includes at least one flexible (e.g., resilient) material. The at least one flexible material can be sufficiently resilient so that portion 340 generates a restoring force in response to being deflected in response to being pressed against the recipient's body by magnetic force 338, the restoring force pressing against the recipient's body (e.g., in a direction substantially opposite to the deflection direction). Examples of flexible materials compatible with certain embodiments described herein include, but are not limited to: rubber; silicone.

[0043] In some embodiments, portion 340 is substantially non-homogeneous and includes at least one non-rigid material and at least one elastic material. Figure 3B As schematically shown, portion 340 may include at least one non-rigid (e.g., soft) layer 344 configured to contact the recipient's body and at least one elastic (e.g., flexible; stretchy) layer 346 configured to reinforce portion 340 (e.g., to generate a restoring force in response to being flexed, the restoring force being in a direction substantially opposite to the flexing direction). Examples of materials for at least one non-rigid layer 344 include, but are not limited to: rubber; silicone. Examples of materials for at least one elastic layer 346 include, but are not limited to: plastic; metal. Although Figure 3B An example device 330 is schematically shown in which at least one elastic layer 346 is sandwiched between two non-rigid layers 334a, b, but other example devices 330 may have other configurations. For example, at least one elastic layer 346 may be sandwiched between the upper portion 350 of the housing 332 and the at least one non-rigid layer 344.

[0044] As Figure 2A and 2B Schematically shown, outer surface 342 of concave and resilient portion 340 may have a first curvature when surface 342 is not pressed against the recipient's body by magnetic force 338, and may have a second curvature when surface 342 is pressed against the recipient's body by magnetic force 338. Surface 342 changes (e.g., flexes) from the first curvature to the second curvature in response to being pressed against the recipient's body by magnetic force 338, and returns (e.g., relaxes back) to the first curvature in response to being removed from the recipient's body. The first curvature may have a first radius of curvature R1 (e.g., at Figure 2A and 2B ), and the second curvature may have a second radius of curvature R2 (e.g., in the cross-sectional plane of Figure 2A and2B In the same cross-sectional plane), the second radius of curvature R2 is greater than the first radius of curvature R1. Figure 2B As schematically shown in FIG. 3 , the outer surface 321 of the recipient's skin 320 beneath the device 330 has a second radius of curvature R2, and in response to being pressed against the outer surface 321 of the recipient's skin 320 by the attractive magnetic force 338, the portion 340 flexes so that the surface 342 substantially conforms to the outer surface 321 of the recipient's skin 320 (e.g., conforms to the curvature of the recipient's scalp). Figure 2A As schematically shown in , before contacting the outer surface 321 of the recipient's skin 320 and after releasing the outer surface 321 of the recipient's skin 320, the surface 342 has a more concave curvature than when in contact with the outer surface 321 of the recipient's skin 320.

[0045] In some embodiments, the relative position of at least one magnet 336 and at least one energy transfer coil 335 is configured to change in response to flexing of portion 340. For example, when device 330 is not in contact with the recipient's body (see, e.g., FIG. 2 ), at least one magnet 336 is closer to at least one energy transfer coil 335 than when device 330 is in contact with the recipient's body (see, e.g., FIG. 3 ). Figure 2B ) is higher. In certain embodiments, the flexure of the portion 340 allows the at least one energy transmission coil 335 to be positioned closer to the at least one internal energy receiving coil 314 than if the portion 340 were not flexible, thereby improving the coupling coefficient between the at least one energy transmission coil 335 and the at least one internal energy receiving coil 314 (e.g., maximizing power transfer efficiency and / or inductive coupling). Compared to other systems that add soft pads or spacers to the rigid lower surface of the housing 332, the flexible surface 340 of certain embodiments described herein does not increase the distance between the at least one magnet 336 and the at least one internal magnetic material 316 or the distance between the at least one energy transmission coil 335 and the at least one internal energy receiving coil 314.

[0046] In some embodiments, portion 340 allows housing 332 to conform to the curvature of a recipient's body (e.g., head), thereby increasing (e.g., maximizing) the surface area of ​​portion 340 that contacts the recipient's skin 320, and reducing (e.g., minimizing) the pressure applied by device 330 to the recipient's skin 320 at a given magnetic force 338, thereby increasing the comfort level of the recipient when wearing device 330. For example, substantially all of the surface area of ​​outer surface 342 can contact outer surface 321 of the recipient's skin 320, thereby distributing magnetic attraction force 338 substantially evenly over substantially all of the surface area of ​​outer surface 342. Additionally, the increased surface area can increase (e.g., maximize) the translational friction between outer surface 321 of the recipient's skin 320 and outer surface 342 of portion 340, thereby reducing (e.g., minimizing) the risk of device 330 being accidentally removed (e.g., displaced; knocked off) from the recipient's body.

[0047] Figure 4 is a flow chart of an example method 400 according to certain embodiments described herein. Figure 2A-2B 3A-3B describe method 400 , but other devices and systems having other configurations of components may also be used to perform method 400 according to certain embodiments described herein.

[0048] In operation block 410, method 400 includes providing a first device (e.g., apparatus 300) configured to be worn on a recipient's skin 320 over a second device (e.g., implant device 310) implanted beneath the recipient's skin 320. The first device includes a compliant housing portion (e.g., portion 340) configured to contact the recipient's skin 320.

[0049] At operation block 420, method 400 further includes magnetically holding the first device over the second device, wherein the compliant housing portion is pressed against the recipient's skin 320. For example, the first device can apply pressure to the recipient's skin 320 by pressing the compliant housing portion against the recipient's skin 320. In some embodiments, magnetically holding the first device over the second device includes generating an attractive magnetic force (e.g., force 338) between the first device and the second device. The attractive magnetic force can extend in a direction substantially perpendicular to and substantially concentric with an outer surface (e.g., surface 342) of the compliant housing portion.

[0050] At operation block 430, method 400 further includes increasing the contact area of ​​the compliant housing portion pressed against the recipient's skin 320. For example, increasing the contact area may include reducing the pressure applied by the first device to the recipient's skin 320 while increasing the translational friction between the compliant housing portion and the recipient's skin 320.

[0051] 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.

[0052] It should be appreciated that the embodiments disclosed herein are not mutually exclusive and may be combined with each other in various arrangements. In addition, although the disclosed methods and apparatus are largely described in the context of various devices, 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 certain attributes described herein.

[0053] 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.

[0054] 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.

[0055] The invention described and claimed herein is not limited in scope by the specific example embodiments disclosed herein, as these embodiments are intended to be illustrative of several aspects of the 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 limited by the claims and their equivalents.

Claims

1. A device comprising: a housing configured to be worn on a recipient's body; a circuit system contained within the housing, the circuit system being configured to wirelessly communicate with an implanted device within the body of the recipient; at least one magnet housed within the housing, the at least one magnet configured to interact with the implant device to generate an attractive magnetic force configured to retain the housing on the recipient's body; as well as A concave and resilient portion configured to contact the recipient's body when the housing is held on the recipient's body by the magnetic force, the portion configured to flex in response to being pressed against the recipient's body by the magnetic force.

2. The apparatus of claim 1, wherein the circuit system comprises a substantially planar wire coil.

3. The apparatus of claim 2, wherein the at least one magnet extends above the substantially planar wire coil.

4. The apparatus of claim 3, wherein the at least one magnet is centered above the substantially planar wire coil.

5. An apparatus according to any preceding claim, wherein the portion comprises a surface configured to contact the body of the recipient, and the magnetic force extends in a direction substantially perpendicular to the surface.

6. The apparatus of claim 5, wherein the surface has a first curvature when the surface is not pressed against the recipient's body by the magnetic force, and has a second curvature when the surface is pressed against the recipient's body by the magnetic force.

7. The apparatus of claim 6, wherein the surface changes from the first curvature to the second curvature in response to being pressed against the recipient's body by the magnetic force, and returns to the first curvature in response to being removed from the recipient's body.

8. An apparatus according to claim 6 or claim 7, wherein the first curvature has a first radius and the second curvature has a second radius, the second radius being greater than the first radius.

9. Apparatus according to any preceding claim, wherein the portion generates a restoring force pressing against the recipient's body in response to being pressed against the recipient's body by the magnetic force.

10. Apparatus according to any preceding claim, wherein the portion has a surface area contacting the recipient's body, and the magnetic force generates a pressure against the recipient's body, the pressure being substantially equally distributed across the surface area.

11. An apparatus according to any preceding claim, wherein the at least one magnet and at least a portion of the circuitry are configured to move relative to each other in response to flexure of the portions.

12. A device according to any preceding claim, wherein the portion comprises at least one non-rigid layer comprising rubber and / or silicone and at least one elastic layer comprising plastic and / or metal.

13. A method comprising: providing a first device configured to be worn on the skin of a recipient over a second device implanted beneath the skin of the recipient, the first device comprising a compliant housing portion configured to contact the skin of the recipient; magnetically retaining the first device over the second device, wherein the compliant housing portion is pressed against the recipient's skin; as well as The contact area of ​​the compliant housing portion pressed against the recipient's skin is increased.

14. The method of claim 13, wherein magnetically retaining the first device over the second device comprises applying pressure to the recipient's skin by pressing the compliant housing portion against the recipient's skin.

15. The method of claim 14, wherein said increasing said contact area comprises decreasing said pressure while increasing translational friction between said compliant housing portion and said recipient's skin.

16. A method according to any one of claims 13 to 15, wherein the magnetically maintaining the first device above the second device includes generating an attractive magnetic force between the first device and the second device, the attractive magnetic force extending in a direction substantially perpendicular to the outer surface of the compliant shell portion and substantially concentric with the outer surface.

17. A device comprising: at least one external magnet configured to be retained to the scalp of a recipient by attractive magnetic forces between the at least one external magnet and at least one internal magnetic material of an implant device beneath the scalp of the recipient; at least one external radio frequency (RF) coil configured to wirelessly communicate with at least one internal RF coil of the implant device; as well as a shell portion comprising at least one flexible material configured to contact the scalp of the recipient, the shell portion comprising a surface configured to substantially conform to the curvature of the recipient's scalp in response to being pressed against the recipient's scalp by the attractive magnetic force.

18. The apparatus of claim 17, wherein the surface is configured to flex so that the at least one external magnet is brought closer to the at least one internal magnetic material.

19. Apparatus according to claim 17 or claim 18, wherein the deflection of the surface increases a coupling coefficient between the at least one external RF coil and the at least one internal RF coil.

20. Apparatus according to any one of claims 17 to 19, wherein the deflection of the surface increases the area of ​​the surface in contact with the recipient's scalp.

21. The apparatus of any one of claims 17 to 20, wherein the at least one external magnet and the at least one external RF coil are configured to move relative to each other in response to deflection of the surface.

22. A device comprising: At least one external device is configured to be held on the skin of a recipient over at least one internal device beneath the skin of the recipient by an attractive force between the at least one external device and the at least one internal device, the at least one external device comprising an elastic wall having a surface configured to contact the skin of the recipient in response to being pressed against the skin of the recipient by the attractive force, substantially conform to the curvature of the skin of the recipient, and generate a restoring force pressed against the skin of the recipient.

23. The system of claim 22, wherein the at least one external device comprises circuitry configured to wirelessly transcutaneously communicate with the at least one internal device.

24. A system according to claim 22 or claim 23, wherein the at least one external device includes at least one magnet and the at least one internal device includes at least one ferromagnetic material, and the attractive force is generated by the at least one magnet and the at least one ferromagnetic material.

25. A system according to any one of claims 22 to 24, wherein the surface is concave and has a first curvature before being pressed against the recipient's skin by the attractive force, a second curvature when pressed against the recipient's skin by the attractive force, and the first curvature after being removed from the recipient's skin.

26. The apparatus of claim 25, wherein the first curvature has a first radius and the second curvature has a second radius, the second radius being greater than the first radius.

27. An apparatus according to any one of claims 22 to 26, wherein the at least one external device comprises a sound processor of a hearing prosthesis, and the at least one internal device comprises a stimulator unit of the hearing prosthesis, the stimulator unit being configured to apply stimulation signals comprising auditory information to the body of the recipient.

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