The present application relates generally to systems and methods for positioning an external portion of a medical device implanted on or within a recipient's body.
Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices can include internal or implantable components/devices, external or wearable components/devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). Medical devices, such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and/or lifestyle enhancement functions and/or recipient monitoring for a number of years.
The types of medical devices and the ranges of functions performed thereby have increased over the years. For example, many medical devices, sometimes referred to as “implantable medical devices,” now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease/injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and/or data received from external devices that are part of, or operate in conjunction with, implantable components.
In one aspect disclosed herein, an apparatus comprises a housing configured to be worn on a recipient's body. The apparatus further comprises circuitry contained within the housing. The circuitry is configured to be in wireless communication with an implanted device within the recipient's body. The apparatus further comprises 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 apparatus further comprises a concave and resilient portion configured to contact the recipient's body while the housing is held by the magnetic force on the recipient's body. The portion is configured to flex in response to being pressed against the recipient's body by the magnetic force.
In another aspect disclosed herein, a method comprises 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 comprises a compliant housing portion configured to contact the recipient's skin. The method further comprises magnetically holding the first device over the second device with the compliant housing portion pressed against the recipient's skin. The method further comprises increasing a contact area of the compliant housing portion pressed against the recipient's skin.
In another aspect disclosed herein, an apparatus comprises at least one external magnet configured to be held onto 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 implanted device beneath the recipient's scalp. The apparatus further comprises at least one external radio-frequency (RF) coil configured to be in wireless communication with at least one internal RF coil of the implanted device. The apparatus further comprises a housing portion comprising at least one flexible material configured to contact the recipient's scalp. The housing portion comprises a surface configured to substantially conform to a curvature of the recipient's scalp in response to being pressed against the recipient's scalp by the attractive magnetic force.
In another aspect disclosed herein, an apparatus comprises 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 comprises a resilient wall having a surface configured to, in response to being pressed against the recipient's skin by the attractive force, contact the recipient's skin, substantially conform to a curvature of the recipient's skin, and generate a restoring force pressing against the recipient's skin.
Implementations are described herein in conjunction with the accompanying drawings, in which:
Certain implementations described herein provide an external portion of a medical device (e.g., an off-the-ear sound processor of an auditory prosthesis) configured to be worn in contact with the recipient's skin. The external portion has a concave surface configured to contact an outer surface of the recipient's skin and to resiliently flex in response to the attractive magnetic force holding the external portion against the skin. By flexing, the surface can conform the curvature of the recipient's body (e.g., head), thereby increasing the contact surface area to reduce the pressure for a given retention force and distributing the retention force more evenly across the contact surface area, both of which increase the recipient's comfort. This increased comfort allows the recipient to withstand a larger range of retention forces, thereby allowing overlap of the magnet strengths used to retain the external portion against the skin. In addition, by flexing, the surface can increase the translational friction between the external portion and the recipient's skin, thereby reducing the risk of unintentional dislodgement of the external portion from the recipient's skin.
The teachings detailed herein are applicable, in at least some implementations, to any type of implantable or non-implantable stimulation system or device (e.g., implantable or non-implantable auditory prosthesis device or system). Implementations can include any type of medical device that can utilize the teachings detailed herein and/or variations thereof. Furthermore, while certain implementations are described herein in the context of auditory prosthesis devices, certain other implementations are compatible in the context of other types of devices or systems (e.g., smart phones; smart speakers).
Merely for ease of description, apparatus and methods disclosed herein are primarily described with reference to an illustrative medical device, namely an implantable transducer assembly including but not limited to: electro-acoustic electrical/acoustic systems, cochlear implant devices, implantable hearing aid devices, middle ear implant devices, bone conduction devices (e.g., active bone conduction devices; passive bone conduction devices, percutaneous bone conduction devices; transcutaneous bone conduction devices), Direct Acoustic Cochlear Implant (DACI), middle ear transducer (MET), electro-acoustic implant devices, other types of auditory prosthesis devices, and/or combinations or variations thereof, or any other suitable hearing prosthesis system with or without one or more external components. Implementations can include any type of auditory prosthesis that can utilize the teachings detailed herein and/or variations thereof. Certain such implementations can be referred to as “partially implantable,” “semi-implantable,” “mostly implantable,” “fully implantable,” or “totally implantable” auditory prostheses. In some implementations, the teachings detailed herein and/or variations thereof can be utilized in other types of prostheses beyond auditory prostheses.
As shown in
As shown in
The power source of the external component 142 is configured to provide power to the auditory prosthesis 100, where the auditory prosthesis 100 includes a battery (e.g., located in the internal component 144, or disposed in a separate implanted location) that is recharged by the power provided from the external component 142 (e.g., via a transcutaneous energy transfer link). The transcutaneous energy transfer link is used to transfer power and/or data to the internal component 144 of the auditory prosthesis 100. Various types of energy transfer, such as infrared (IR), electromagnetic, capacitive, and inductive transfer, may be used to transfer the power and/or data from the external component 142 to the internal component 144. During operation of the auditory prosthesis 100, the power stored by the rechargeable battery is distributed to the various other implanted components as needed.
The internal component 144 comprises an internal receiver unit 132, a stimulator unit 120, and an elongate electrode assembly 118. In some implementations, the internal receiver unit 132 and the stimulator unit 120 are hermetically sealed within a biocompatible housing. The internal receiver unit 132 comprises an internal coil 136 (e.g., a wire antenna coil comprising multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire), and preferably, a magnet (also not shown) fixed relative to the internal coil 136. The internal receiver unit 132 and the stimulator unit 120 are hermetically sealed within a biocompatible housing, sometimes collectively referred to as a stimulator/receiver unit. The internal coil 136 receives power and/or data signals from the external coil 130 via a transcutaneous energy transfer link (e.g., an inductive RF link). The stimulator unit 120 generates electrical stimulation signals based on the data signals, and the stimulation signals are delivered to the recipient via the elongate electrode assembly 118.
The elongate electrode assembly 118 has a proximal end connected to the stimulator unit 120, and a distal end implanted in the cochlea 140. The electrode assembly 118 extends from the stimulator unit 120 to the cochlea 140 through the mastoid bone 119. In some implementations, the electrode assembly 118 may be implanted at least in the basal region 116, and sometimes further. For example, the electrode assembly 118 may extend towards apical end of cochlea 140, referred to as cochlea apex 134. In certain circumstances, the electrode assembly 118 may be inserted into the cochlea 140 via a cochleostomy 122. In other circumstances, a cochleostomy may be formed through the round window 121, the oval window 112, the promontory 123, or through an apical turn 147 of the cochlea 140.
The elongate electrode assembly 118 comprises a longitudinally aligned and distally extending array 146 of electrodes or contacts 148, sometimes referred to as electrode or contact array 146 herein, disposed along a length thereof. Although the electrode array 146 can be disposed on the electrode assembly 118, in most practical applications, the electrode array 146 is integrated into the electrode assembly 118 (e.g., the electrode array 146 is disposed in the electrode assembly 118). As noted, the stimulator unit 120 generates stimulation signals which are applied by the electrodes 148 to the cochlea 140, thereby stimulating the auditory nerve 114.
While
For the example auditory prosthesis 200 shown in
The actuator 210 of the example auditory prosthesis 200 shown in
During normal operation, ambient acoustic signals (e.g., ambient sound) impinge on the recipient's tissue and are received transcutaneously at the microphone assembly 206. Upon receipt of the transcutaneous signals, a signal processor within the implantable assembly 202 processes the signals to provide a processed audio drive signal via wire 208 to the actuator 210. As will be appreciated, the signal processor may utilize digital processing techniques to provide frequency shaping, amplification, compression, and other signal conditioning, including conditioning based on recipient-specific fitting parameters. The audio drive signal causes the actuator 210 to transmit vibrations at acoustic frequencies to the connection apparatus 216 to affect the desired sound sensation via mechanical stimulation of the incus 109 of the recipient.
The subcutaneously implantable microphone assembly 202 is configured to respond to auditory signals (e.g., sound; pressure variations in an audible frequency range) by generating output signals (e.g., electrical signals; optical signals; electromagnetic signals) indicative of the auditory signals received by the microphone assembly 202, and these output signals are used by the auditory prosthesis 100, 200 to generate stimulation signals which are provided to the recipient's auditory system. To compensate for the decreased acoustic signal strength reaching the microphone assembly 202 by virtue of being implanted, the diaphragm of an implantable microphone assembly 202 can be configured to provide higher sensitivity than are external non-implantable microphone assemblies. For example, the diaphragm of an implantable microphone assembly 202 can be configured to be more robust and/or larger than diaphragms for external non-implantable microphone assemblies.
The example auditory prostheses 100 shown in
The implantable device 310 comprises at least one implantable housing 312 configured to be positioned beneath tissue of the recipient's body. For example, as shown in
In certain implementations, the apparatus 330 comprises a housing 332 configured to be worn on a recipient's body and circuitry 334 contained within the housing 332. The circuitry 334 is configured to be in wireless communication with the implanted device 310 within the recipient's body. The apparatus 330 further comprises at least one magnet 336 contained within the housing 332. The at least one magnet 336 is configured to interact with the implanted device 310 to generate an attractive magnetic force 338 configured to hold the housing 332 on the recipient's body. The apparatus 330 further comprises a concave (e.g., incurvate) and resilient (e.g., flexible; elastic) portion 340 configured to contact the recipient's body while the housing 332 is held by the magnetic force on the recipient's body. The portion 340 is configured to flex in response to being pressed against the recipient's body by the magnetic force 338.
In certain implementations, the housing 332 of the apparatus 330 is configured to be positioned on and/or over an outer surface 321 of the skin 320 and to hermetically seal the circuitry 334 and/or the at least one magnet 336 from an 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) less than or equal to 40 millimeters (e.g., in a range of 15 millimeters to 35 millimeters; in a range of 25 millimeters to 35 millimeters; in a range of less than 30 millimeters; in a range of 15 millimeters to 30 millimeters). The housing 422 can have a thickness (e.g., in a direction substantially perpendicular to the recipient's skin 320) less than or equal to 10 millimeters (e.g., in a range of less than or equal to 7 millimeters, in a range of less than or equal to 6 millimeters; in a range of less than or equal to 5 millimeters).
In certain implementations, the circuitry 334 of the apparatus 330 comprises at least one energy transmission coil 335 (e.g., a substantially planar electrically conductive wire coil with multiple windings of electrically insulated single-strand or multi-strand copper wire; copper traces on epoxy 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) less than or equal to 40 millimeters (e.g., in a range of 15 millimeters to 35 millimeters; in a range of 25 millimeters to 35 millimeters; in a range of less than 30 millimeters; in a range of 15 millimeters to 30 millimeters). In certain implementations, the at least one energy transmission coil 335 can be sufficiently flexible to flex in response to the flexing of the portion 340, while in certain other implementations, the at least one energy transmission coil 335 is substantially rigid so as to not flex in response to the flexing of the portion 340. In certain implementations, the at least one energy transmission coil 335 is within the concave and resilient portion 340.
In certain implementations, the circuitry 334 is configured to be in wireless electrical communication (e.g., via a radio-frequency or RF link; via a magnetic induction link) with the at least one internal energy reception coil 314 when the apparatus 330 is positioned on the skin 320 of the recipient above the implanted device 310 (e.g., the apparatus 330 being held in place by the magnetic attractive force 338 between the at least one internal magnetic material 316 and the at least one magnet 336). For example, the at least one energy transmission coil 335 of the circuitry 334 can be inductively coupled with the at least one internal energy reception coil 314 and configured to wirelessly transmit electrical power to the at least one internal energy reception coil 314 and/or configured to wirelessly transmit information (e.g., data signals; control signals) to and/or to wirelessly receive information from the at least one internal energy reception coil 314.
In certain implementations, the circuitry 334 further comprises one or more microprocessors (e.g., application-specific integrated circuits; generalized integrated circuits programmed by software with computer executable instructions; microelectronic circuitry; microcontrollers) configured to control operation of the apparatus 330 and/or the implanted device 310 (e.g., set or adjust parameters of the energy transfer in response to user input and/or conditions during operation). In certain implementations, the circuitry 334 further comprises 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) comprising computer executable instructions for instructing the one or more microprocessors (e.g., executable data access logic, evaluation logic, and/or information outputting logic). In certain implementations, the one or more microprocessors execute the instructions of the software to provide functionality as described herein. In certain implementations, the circuitry 334 further comprises at least one energy storage device (e.g., battery; capacitor) configured to provide energy to the other components of the apparatus 330.
In certain implementations, the at least one magnet 336 comprises a ferromagnetic material, a ferrimagnetic material, and/or a permanent magnet (e.g., disk; plate) positioned within the housing 332. As schematically illustrated by
In certain implementations, the at least one magnet 336 is configured to establish the magnetic attractive force 338 between the apparatus 330 and the implanted device 310 (e.g., generate the magnetic attractive force 338 with the at least one internal magnetic material 316 of the implanted device 310) sufficient to hold the apparatus 330 on the recipient's body (e.g., with an outer surface 342 of the portion 340 pressed against the outer surface 321 of the skin 330). To produce 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 recipient's skin 320, 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 along a direction substantially perpendicular to the portion 340 (e.g., substantially perpendicular to the outer surface 342; substantially perpendicular to the recipient's skin 320).
In certain implementations, the portion 340 comprises an outer surface 342 configured to contact the recipient's body. The surface 342 can be configured to flex in response to being pressed against the outer surface 321 of the recipient's skin 320 (e.g., scalp) by the magnetic force 338 between the at least one magnet 336 and the at least one internal magnetic material 316. In certain implementations, as schematically illustrated by
In certain implementations, the portion 340 is substantially heterogeneous and comprises at least one non-rigid material and at least one resilient material. For example, as schematically illustrated by
As schematically illustrated by
In certain implementations, the relative positions of the at least one magnet 336 and the at least one energy transmission coil 335 are configured to change in response to the flexing of the portion 340. For example, when the apparatus 330 is not in contact with the recipient's body (see, e.g.,
In certain implementations, the portion 340 allows the housing 332 to conform to the curvature of the recipient's body (e.g., head), thereby increasing (e.g., maximizing) the surface area of the portion 340 contacting the recipient's skin 320 and reducing (e.g., minimizing) the pressure applied to the recipient's skin 320 by the apparatus 330 for a given magnetic force 338, thereby increasing the comfort to the recipient when wearing the apparatus 330. For example, substantially all of the surface area of the outer surface 342 can be in contact with the outer surface 321 of the recipient's skin 320, thereby distributing the magnetic attractive force 338 substantially evenly across substantially all of the surface area of the outer surface 342. In addition, the increased surface area can increase (e.g., maximize) the translational friction between the outer surface 321 of the recipient's skin 320 and the outer surface 342 of the portion 340, thereby reducing (e.g., minimizing) the risk of the apparatus 330 being removed (e.g., dislodged; knocked off) from the recipient's body unintentionally.
In an operational block 410, the method 400 comprises providing a first device (e.g., apparatus 300) configured to be worn on a recipient's skin 320 over a second device (e.g., implanted device 310) implanted beneath the recipient's skin 320. The first device comprises a compliant housing portion (e.g., portion 340) configured to contact the recipient's skin 320.
In an operational block 420, the method 400 further comprises magnetically holding the first device over the second device with the compliant housing portion pressed against the recipient's skin 320. For example, the first device can apply a pressure to the recipient's skin 320 by pressing the compliant housing portion against the recipient's skin 320. In certain implementations, magnetically holding the first device over the second device comprises generating an attractive magnetic force (e.g., force 338) between the first device and the second device. The attractive magnetic force can extend along a direction substantially perpendicular to an outer surface (e.g., surface 342) of the compliant housing portion and substantially concentric with the outer surface.
In an operational block 430, the method 400 further comprises increasing a contact area of the compliant housing portion pressed against the recipient's skin 320. For example, increasing the contact area can comprise reducing the pressure applied to the recipient's skin 320 by the first device while increasing a translational friction force between the compliant housing portion and the recipient's skin 320.
Although commonly used terms are used to describe the systems and methods of certain implementations for ease of understanding, these terms are used herein to have their broadest reasonable interpretations. Although various aspects of the disclosure are described with regard to illustrative examples and implementations, the disclosed examples and implementations should not be construed as limiting. Conditional language, such as, among others, “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain implementations include, while other implementations do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more implementations or that one or more implementations necessarily include logic for deciding, with or without user input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular implementation. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.
It is to be appreciated that the implementations disclosed herein are not mutually exclusive and may be combined with one another in various arrangements. In addition, although the disclosed methods and apparatuses have largely been described in the context of various devices, various implementations described herein can be incorporated in a variety of other suitable devices, methods, and contexts. More generally, as can be appreciated, certain implementations described herein can be used in a variety of implantable medical device contexts that can benefit from certain attributes described herein.
Language of degree, as used herein, such as the terms “approximately,” “about,” “generally,” and “substantially,” represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may refer to an amount that is within ±10% of, within ±5% of, within ±2% of, within ±1% of, or within ±0.1% of the stated amount. As another example, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by ±10 degrees, by ±5 degrees, by ±2 degrees, by ±1 degree, or by ±0.1 degree, and the terms “generally perpendicular” and “substantially perpendicular” refer to a value, amount, or characteristic that departs from exactly perpendicular by ±10 degrees, by ±5 degrees, by ±2 degrees, by ±1 degree, or by ±0.1 degree. The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” less than,” “between,” and the like includes the number recited. As used herein, the meaning of “a,” “an,” and “said” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “into” and “on,” unless the context clearly dictates otherwise.
While the methods and systems are discussed herein in terms of elements labeled by ordinal adjectives (e.g., first, second, etc.), the ordinal adjective are used merely as labels to distinguish one element from another (e.g., one signal from another or one circuit from one another), and the ordinal adjective is not used to denote an order of these elements or of their use.
The invention described and claimed herein is not to be limited in scope by the specific example implementations herein disclosed, since these implementations are intended as illustrations, and not limitations, of several aspects of the invention. Any equivalent implementations are intended to be within the scope of this invention. Indeed, various modifications of the invention in form and detail, in addition to those shown and described herein, will become apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the claims. The breadth and scope of the invention should not be limited by any of the example implementations disclosed herein but should be defined only in accordance with the claims and their equivalents.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2023/052594 | 3/16/2023 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63363546 | Apr 2022 | US |