The present application relates generally to systems and methods for wirelessly communicating data to and/or from a 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 at least one implantable housing containing circuitry and configured to be implanted on and substantially parallel to a bone surface within a recipient. The apparatus further comprises at least one electrical conduit in electrical communication with the circuitry and extending from the at least one implantable housing to a region within the recipient. The apparatus further comprises at least one magnetic induction antenna in electrical communication with the at least one electrical conduit and spaced from the at least one implantable housing. The at least one magnetic induction antenna extends around an antenna axis. The at least one magnetic induction antenna is configured to be affixed within the region with the antenna axis substantially non-parallel and substantially non-orthogonal to the bone surface.
In another aspect disclosed herein, a method comprises receiving, using a plurality of implanted magnetic induction antennas, corresponding portions of a magnetic flux from at least one external magnetic induction antenna. The method further comprises detecting the amplitude of an electric signal induced within each of the implanted magnetic induction antennas by the corresponding received portion of the magnetic flux. The method further comprises determining which of the implanted magnetic induction antennas has the largest induced signal amplitude. The method further comprises selecting the implanted magnetic induction antenna corresponding to the largest induced signal amplitude.
In another aspect disclosed herein, an apparatus comprises at least one external device configured to be worn by a recipient. The at least one external device comprises at least one external magnetic induction antenna configured to generate a magnetic flux. The apparatus further comprises at least one implantable device comprising circuitry and at least a first magnetic induction antenna and a second magnetic induction antenna in electrical communication with the circuitry. The first and second magnetic induction antennas are affixed to one another. The first magnetic induction antenna has a first antenna axis and the second magnetic induction antenna has a second antenna axis substantially non-parallel to the first antenna axis.
Implementations are described herein in conjunction with the accompanying drawings, in which:
Certain implementations described herein provide a medical implant having at least one magnetic induction (MI) antenna configured to be implanted within a recipient's body and configured to be in communication with an external MI antenna while avoiding being in a dead zone of the external MI antenna. The at least one implanted MI antenna can be on a malleable lead extending from an implantable housing (e.g., positioned on a skull bone surface) such that the at least one implantable MI antenna can be positioned in a region (e.g., mastoid cavity) spaced from the implantable housing with a position and/or orientation configured to facilitate communication with the external MI antenna. The at least one implanted MI antenna can comprise a plurality of antenna coils that are oriented at least 45 degrees from one another (e.g., two antenna coils in a “V” or “T” formation) and the implant can be configured to select among the antenna coils to utilize an antenna coil having a sufficiently large coupling with the external MI antenna.
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.
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 example apparatus 300 is shown in
In certain implementations, the at least one external device 450 can comprise a first portion 460 configured to be worn on the recipient's skin 406 over the implantable housing 310 and a second portion 470 configured to be worn in proximity to (e.g., over) the at least one MI antenna 330, the at least one external device 450 configured to provide power and/or data to the apparatus 300 and/or to receive data from the apparatus 300. In certain implementations, the first portion 460 and the second portion 470 are separate from one another (e.g., as shown in
The first portion 460 (e.g., an “on-the-go” or OTG sound processor comprising driver circuitry) can comprise an energy transmission coil 462 and an external magnetic material 464. For example, the first portion 460 can comprise a biocompatible (e.g., skin-friendly) housing configured to hermetically seal the energy transmission coil 462 and/or the external magnetic material 464 from an environment surrounding the housing. The housing can also be substantially transparent to the electromagnetic or magnetic fields generated by the energy transmission coil 462 such that the housing does not substantially interfere with the power transmission to the apparatus 300.
The energy transmission coil 462 can comprise multiple turns of electrically insulated single-strand or multi-strand copper wire (e.g., a planar electrically conductive wire with multiple windings having a substantially circular, rectangular, spiral, or oval shape or other shape) or copper traces on epoxy of a printed circuit board. For example, the energy transmission coil 462 can have a diameter, length, and/or width (e.g., along a lateral direction substantially parallel to the recipient's skin 406) less than or equal to 60 millimeters (e.g., in a range of 15 millimeters to 40 millimeters; in a range of 25 millimeters to 50 millimeters; in a range of less than 30 millimeters; in a range of 20 millimeters to 60 millimeters; in a range greater than 60 millimeters).
The at least one magnetic material 464 of the first portion 460 can be configured to interact with a portion of the apparatus 300 (e.g., at least one internal magnetic material 315) when the first portion 460 is positioned on or over the skin 406 of the recipient above the apparatus 300 to generate a magnetic restoring force which holds the first portion 460 on the recipient's skin 406 such that the energy transmission coil 462 is in operative wireless communication with the apparatus 300 to wirelessly and transcutaneously transfer energy from the first portion 460 to the apparatus 300 (e.g., via a radio-frequency or RF link).
The second portion 470 (e.g., a “behind-the-ear” or BTE sound processor comprising driver circuitry and is held in place on and/or behind the recipient's pinna by a hook portion of the second portion 470) can comprise at least one external magnetic induction (MI) antenna 472 configured to interact with the at least one MI antenna 330 of the apparatus 300 to wirelessly and transcutaneously transfer data from the second portion 470 to the apparatus 300 and/or from the apparatus 300 to the second portion 470.
For example, the first portion 460 and/or the second portion 470 can comprise circuitry comprising one or more microprocessors (e.g., application-specific integrated circuits; generalized integrated circuits programmed by software with computer executable instructions; microelectronic circuitry; microcontrollers) and 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) 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. The circuitry can be configured to receive status data signals wirelessly communicated from the apparatus 300 via the at least one MI antenna 330 and the at least one external MI antenna 472. Furthermore, the circuitry can be configured to, in response to user input and/or conditions during operation, generate and wirelessly transmit control signals to the apparatus 300 via the at least one external MI antenna 472 and the at least one MI antenna 330 (e.g., to set or adjust operational parameters of the apparatus 300).
In certain implementations, the at least one implantable housing 310 is configured to be positioned beneath tissue of the recipient's body. For example, as shown in
The circuitry 312 of the at least one implantable housing 310 can comprise at least one internal energy reception coil 313 (e.g., a planar electrically conductive wire with multiple windings) and control circuitry 314 (e.g., at least one battery and/or capacitor and at least one microprocessor). The at least one internal energy reception coil 313 can be configured to wirelessly and transcutaneously receive power from an external source (e.g., the energy transmission coil 462 of the at least one external device 450). The control circuitry 314 can be configured to receive, store, and/or use the power from the at least one internal energy reception coil 313 and to control the one or more active elements of the apparatus 300.
The at least one implantable housing 310 can further comprise at least one internal magnetic (e.g., ferromagnetic; ferrimagnetic; permanent magnet; diamagnetic magnet) material 315 (e.g., disk; plate) configured to establish a magnetic attraction between the external magnetic material 464 of the at least one external device 450 with sufficient strength to hold the at least one external device 450 against an outer surface of the skin 406. For example, as shown in
In certain implementations, the at least one electrical conduit 320 comprises at least one electrically conductive wire having a first end portion in electrical communication with the circuitry 312 (e.g., the control circuitry 314 within the second housing portion 316b) and a second end portion in electrical communication with the at least one MI antenna 330. A length of the at least one electrical conduit 320 can be in a range of 5 millimeters to 40 millimeters. The at least one electrical conduit 320 can extend from a first region 410 of the recipient's body containing the at least one implantable housing 310 to a second region 420 of the recipient's body containing the at least one MI antenna 330. The at least one electrical conduit 320 can comprise multiple electrical conduits (e.g., two electrical conduits for each MI antenna 330). While
In certain implementations, the at least one electrical conduit 320 is malleable (e.g., bendable) such that a position and/or an orientation of the at least one MI antenna 330 relative to the at least one implantable housing 310 can be controllably adjusted during an implantation process. For example, as shown in
In certain implementations, the at least one MI antenna 330 is sufficiently small to fit within the volume of the second region 420 in which the at least one MI antenna 330 is to be implanted. For example, to be implanted within a mastoid cavity, as schematically illustrated in
In certain implementations, the at least one MI antenna 330 comprises a single substantially cylindrical wire coil 510 wound around and extending along the antenna axis 332. For example, as schematically illustrated by
In certain other implementations, the at least one MI antenna 330 comprises a single substantially planar wire spiral 530 wound around and substantially orthogonal to the antenna axis 332. An electrical current flowing through the wire spiral 530 can generate a magnetic dipole moment that is substantially coincident with the antenna axis 332. The wire spiral 530 (e.g., an electrically insulated single-strand or multi-strand platinum or gold wire) can have a plurality of coil windings (e.g., 2, 3, 4, 5, 6, or more) around the antenna axis 332. While
In certain implementations, the MI antenna 330 of
As schematically illustrated by
For example, optimal locations and/or orientations of the MI antenna 330 can be calculated prior to the implantation process, based on analysis of the recipient's anatomy to determine the most likely position and orientation of the at least one external MI antenna 472, and these optimal locations and/or orientations can be communicated to the practitioner performing the implantation (e.g., in an implantation guide or instructions) by reference to anatomical landmarks (e.g., the external auditory canal, ossicles, round window). For another example, an optimal location and/or orientation of the MI antenna 330 can be determined by the practitioner during the implantation process by using a feedback system in which an external MI antenna 472 is placed in the most likely position and orientation and is used to generate a time-varying magnetic field and the MI antenna 330 is moved around within the second region 420 to find a location and/or orientation of the MI antenna 330 which yields a optimal (or at least acceptable) MI coupling to the external MI antenna 472.
In certain implementations, the at least one MI antenna 330 comprises multiple MI antennas 330 with the antenna axes 332 of the MI antennas 330 substantially non-parallel to one another. For example, the at least one MI antenna 330 schematically illustrated by
In
As schematically illustrated by
In certain implementations, the at least one MI antenna 330 is configured to be in operative communication with the at least one external MI antenna 472 of an external device 470 (e.g., BTE sound processor). The at least one MI antenna 330 can bound an antenna region through which magnetic flux from the at least one external MI antenna 472 extends. For example, the wire coil 510 of
In certain implementations in which the at least one MI antenna 330 comprises multiple MI antennas 330, by virtue of at least two of the MI antennas 330 having antenna axes 332 that are substantially perpendicular to one another, at least one of the multiple MI antennas 330 bounds an antenna region through which magnetic flux from the at least one external MI antenna 472 extends. For example, the substantially cylindrical volume bounded by at least one of the wire coils 510 of
In certain implementations in which the at least one MI antenna 330 comprises multiple MI antennas 330, the circuitry 312 of the apparatus 300 comprises antenna selection circuitry in operative communication with the multiple MI antennas 330. The antenna selection circuitry is configured to detect the amplitude of the electric voltage and/or electric current induced within each of the multiple MI antennas 330 by the magnetic flux generated by the at least one external MI antenna 472, to determine which of the multiple MI antennas 330 has the largest amplitude of the induced electric voltage and/or electric current, and to select the induced electric voltage and/or electric current having the largest amplitude for use by the apparatus 300.
In an operational block 610, the method 600 comprises receiving, using a plurality of implanted MI antennas 330, corresponding portions of a magnetic flux from at least one external MI antenna 472. At least two of the implanted MI antennas 330 can have antenna axes 332 that are substantially non-parallel to one another (e.g., substantially orthogonal to one another). The implanted MI antennas 330 can be within a recipient's body, and the at least one external MI antenna 472 can be part of an external device outside the recipient's body. The corresponding portion of the magnetic flux received by an implanted MI antenna 330 can be the portion of the magnetic flux extending through an antenna region of the implanted MI antenna 330 in a direction along an axis of the implanted MI antenna 330 (e.g., having a non-zero component that is parallel to the antenna axis 332).
In an operational block 620, the method 600 further comprises detecting the amplitude of an electric signal (e.g., voltage and/or current) induced within each of the implanted MI antennas 330 by the corresponding received portion of the magnetic flux. At least one of the implanted MI antennas 330 has an induced signal with a non-zero amplitude. Each of the implanted MI antennas 330 receiving a portion of the magnetic flux extending at least partially along the axis of the implanted MI antenna 330 has an induced signal with a non-zero amplitude.
In an operational block 630, the method 600 further comprises determining which of the implanted MI antennas 330 has the largest induced signal amplitude. For example, a comparison of each of the induced signal amplitudes from each of the implanted MI antennas 330 can identify the largest induced signal amplitude and can then identify which of the implanted MI antennas 330 corresponds to this largest induced signal amplitude.
In an operational block 640, the method 600 further comprises selecting the implanted MI antenna 330 corresponding to the largest induced signal amplitude. The selected implanted MI antenna 330 can then be used by the apparatus 300 as a source of information (e.g., data and/or commands) and/or power from the external device for operation of the apparatus 300. For example, for an implanted portion of an auditory prosthesis system, the selected implanted MI antenna 330 can be used as a source of data and/or commands from an external portion of the auditory prosthesis system.
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 |
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PCT/IB2023/051585 | 2/22/2023 | WO |
Number | Date | Country | |
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63269230 | Mar 2022 | US |