Patent ID: 12220596

DETAILED DESCRIPTION

Systems and methods for providing electromagnetic therapy to an implantable device recipient are described herein. For example, a system may include a coil configured to be positioned over a wound on a head of a recipient, the wound created during an implant procedure in which a cochlear implant is implanted within the recipient. The system may further include a controller communicatively coupled to the coil. The controller may be configured to selectively operate in a therapeutic mode in which the controller applies therapeutic electromagnetic pulses by way of the coil to the wound. The therapeutic electromagnetic pulses may be configured to alleviate pain felt by the recipient while the wound heals. The controller may be further configured to selectively operate in a cochlear implant interface mode in which the controller communicates by way of the coil with the cochlear implant.

In another exemplary configuration, a system may include a coil configured to be positioned over a wound on a body and held in place on the body by a magnet implanted within the body. The system may further include a controller communicatively coupled to the coil, the controller configured to apply therapeutic electromagnetic pulses by way of the coil to the wound. In this configuration, the magnet may be included in an implantable assembly that also includes an implantable device (e.g., an implantable stimulator, a cochlear implant, and/or any other type of implantable medical device). The controller may be configured to communicate with the implantable device by way of the coil.

The systems and methods described herein may advantageously provide various benefits to an implantable device recipient. For example, the systems and methods described herein may use the same components (e.g., a headpiece including a coil) to both aid in the healing process of a wound created during a cochlear implant insertion procedure (or any other type of implantable device insertion procedure) and communicate with the cochlear implant after the cochlear implant has been implanted within the recipient. The electromagnetic therapy provided by the systems and methods described herein may be used pre-operatively (e.g., to condition or otherwise prepare an insertion site on the head of the recipient prior to surgery), intra-operatively (e.g., to reduce inflammation, pain, or other effects of the surgery), and/or post-operatively (e.g., to reduce pain and/or accelerate the rate of healing of the wound created during the surgery). These and other advantages and benefits of the systems and methods described herein will be made apparent herein.

FIG.1illustrates an exemplary cochlear implant system100configured to be used by a recipient. As shown, cochlear implant system100includes a cochlear implant102, an electrode lead104physically coupled to cochlear implant102and having an array of electrodes106, and a controller108configured to be communicatively coupled to cochlear implant102by way of a communication link110.

The cochlear implant system100shown inFIG.1is unilateral (i.e., associated with only one ear of the recipient). Alternatively, a bilateral configuration of cochlear implant system100may include separate cochlear implants and electrode leads for each ear of the recipient. In the bilateral configuration, controller108may be implemented by a single controller configured to interface with both cochlear implants or by two separate controllers each configured to interface with a different one of the cochlear implants.

Cochlear implant102may be implemented by any suitable type of implantable stimulator. For example, cochlear implant102may be implemented by an implantable cochlear stimulator. Additionally or alternatively, cochlear implant102may be implemented by a brainstem implant and/or any other type of device that may be implanted within the recipient and configured to apply electrical stimulation to one or more stimulation sites located along an auditory pathway of the recipient.

In some examples, cochlear implant102may be configured to generate electrical stimulation representative of an audio signal processed by controller108in accordance with one or more stimulation parameters transmitted to cochlear implant102by controller108. Cochlear implant102may be further configured to apply the electrical stimulation to one or more stimulation sites (e.g., one or more intracochlear locations) within the recipient by way of one or more electrodes106on electrode lead104. In some examples, cochlear implant102may include a plurality of independent current sources each associated with a channel defined by one or more of electrodes106. In this manner, different stimulation current levels may be applied to multiple stimulation sites simultaneously by way of multiple electrodes106.

Cochlear implant102may additionally or alternatively be configured to generate, store, and/or transmit data. For example, cochlear implant may use one or more electrodes106to record one or more signals (e.g., one or more voltages, impedances, evoked responses within the recipient, and/or other measurements) and transmit, by way of communication link110, data representative of the one or more signals to controller108. In some examples, this data is referred to as back telemetry data.

Electrode lead104may be implemented in any suitable manner. For example, a distal portion of electrode lead104may be pre-curved such that electrode lead104conforms with the helical shape of the cochlea after being implanted. Electrode lead104may alternatively be naturally straight or of any other suitable configuration.

In some examples, electrode lead104includes a plurality of wires (e.g., within an outer sheath) that conductively couple electrodes106to one or more current sources within cochlear implant102. For example, if there are n electrodes106on electrode lead104and n current sources within cochlear implant102, there may be n separate wires within electrode lead104that are configured to conductively connect each electrode106to a different one of the n current sources. Exemplary values for n are 8, 12, 16, or any other suitable number.

Electrodes106are located on at least a distal portion of electrode lead104. In this configuration, after the distal portion of electrode lead104is inserted into the cochlea, electrical stimulation may be applied by way of one or more of electrodes106to one or more intracochlear locations. One or more other electrodes (e.g., including a ground electrode, not explicitly shown) may also be disposed on other parts of electrode lead104(e.g., on a proximal portion of electrode lead104) to, for example, provide a current return path for stimulation current applied by electrodes106and to remain external to the cochlea after the distal portion of electrode lead104is inserted into the cochlea. Additionally or alternatively, a housing of cochlear implant102may serve as a ground electrode for stimulation current applied by electrodes106.

Controller108may be configured to interface with (e.g., control and/or receive data from) cochlear implant102. For example, controller108may transmit commands (e.g., stimulation parameters and/or other types of operating parameters in the form of data words included in a forward telemetry sequence) to cochlear implant102by way of communication link110. Controller108may additionally or alternatively provide operating power to cochlear implant102by transmitting one or more power signals to cochlear implant102by way of communication link110. Controller108may additionally or alternatively receive data from cochlear implant102by way of communication link110.

Communication link110may be implemented by any suitable number of wired and/or wireless bidirectional and/or unidirectional links.

As shown, controller108includes a memory112and a processor114configured to be selectively and communicatively coupled to one another. In some examples, memory112and processor114may be distributed between multiple devices and/or multiple locations as may serve a particular implementation.

Memory112may be implemented by any suitable non-transitory computer-readable medium and/or non-transitory processor-readable medium, such as any combination of non-volatile storage media and/or volatile storage media. Exemplary non-volatile storage media include, but are not limited to, read-only memory, flash memory, a solid-state drive, a magnetic storage device (e.g., a hard drive), ferroelectric random-access memory (“RAM”), and an optical disc. Exemplary volatile storage media include, but are not limited to, RAM (e.g., dynamic RAM).

Memory112may maintain (e.g., store) executable data used by processor114to perform one or more of the operations described herein. For example, memory112may store instructions116that may be executed by processor114to perform any of the operations described herein. Instructions116may be implemented by any suitable application, program (e.g., sound processing program), software, code, and/or other executable data instance. Memory112may also maintain any data received, generated, managed, used, and/or transmitted by processor114.

Processor114may be configured to perform (e.g., execute instructions116stored in memory112to perform) various operations with respect to cochlear implant102.

To illustrate, processor114may be configured to control an operation of cochlear implant102. For example, processor114may receive an audio signal (e.g., by way of a microphone communicatively coupled to controller108, a wireless interface (e.g., a Bluetooth interface), and/or a wired interface (e.g., an auxiliary input port)). Processor114may process the audio signal in accordance with a sound processing program (e.g., a sound processing program stored in memory112) to generate appropriate stimulation parameters. Processor114may then transmit the stimulation parameters to cochlear implant102to direct cochlear implant102to apply electrical stimulation representative of the audio signal to the recipient.

In some implementations, processor114may also be configured to apply acoustic stimulation to the recipient. For example, a receiver (also referred to as a loudspeaker) may be optionally coupled to controller108. In this configuration, processor114may deliver acoustic stimulation to the recipient by way of the receiver. The acoustic stimulation may be representative of an audio signal (e.g., an amplified version of the audio signal), configured to elicit an evoked response within the recipient, and/or otherwise configured. In configurations in which processor114is configured to both deliver acoustic stimulation to the recipient and direct cochlear implant102to apply electrical stimulation to the recipient, cochlear implant system100may be referred to as a bimodal hearing system and/or any other suitable term.

Processor114may be additionally or alternatively configured to receive and process data generated by cochlear implant102. For example, processor114may receive data representative of a signal recorded by cochlear implant102using one or more electrodes106and, based on the data, adjust one or more operating parameters of controller108. Additionally or alternatively, processor114may use the data to perform one or more diagnostic operations with respect to cochlear implant102and/or the recipient.

Other operations may be performed by processor114as may serve a particular implementation. In the description provided herein, any references to operations performed by controller108and/or any implementation thereof may be understood to be performed by processor114based on instructions116stored in memory112.

Controller108may be implemented by one or more devices configured to interface with cochlear implant102. To illustrate,FIG.2shows an exemplary configuration200of cochlear implant system100in which controller108is implemented by a sound processor202configured to be located external to the recipient. In configuration200, sound processor202is communicatively coupled to a microphone204and to a headpiece206that are both configured to be located external to the recipient.

Sound processor202may be implemented by any suitable device that may be worn or carried by the recipient. For example, sound processor202may be implemented by a behind-the-ear (“BTE”) unit configured to be worn behind and/or on top of an ear of the recipient. Additionally or alternatively, sound processor202may be implemented by an off-the-ear unit (also referred to as a body worn device) configured to be worn or carried by the recipient away from the ear. Additionally or alternatively, at least a portion of sound processor202is implemented by circuitry within headpiece206.

Microphone204is configured to detect one or more audio signals (e.g., that include speech and/or any other type of sound) in an environment of the recipient. Microphone204may be implemented in any suitable manner. For example, microphone204may be implemented by a microphone that is configured to be placed within the concha of the ear near the entrance to the ear canal, such as a T-MIC™ microphone from Advanced Bionics. Such a microphone may be held within the concha of the ear near the entrance of the ear canal during normal operation by a boom or stalk that is attached to an ear hook configured to be selectively attached to sound processor202. Additionally or alternatively, microphone204may be implemented by one or more microphones in or on headpiece206, one or more microphones in or on a housing of sound processor202, one or more beam-forming microphones, and/or any other suitable microphone as may serve a particular implementation.

Headpiece206may be selectively and communicatively coupled to sound processor202by way of a communication link208(e.g., a cable or any other suitable wired or wireless communication link), which may be implemented in any suitable manner. As shown, headpiece206includes a coil210, which may be implemented by any suitable antenna, electromagnetic field generator, and/or wireless communication component as may serve a particular implementation. As described herein, while sound processor202(or any other implementation of controller108) operates in a therapeutic mode, coil210may be used to apply therapeutic electromagnetic pulses to a wound. While sound processor202operates in a cochlear implant interface mode, coil210may be used as an external antenna configured to facilitate selective wireless coupling of sound processor202to cochlear implant102. In this configuration, headpiece206may be affixed to the recipient's head and positioned such that the coil210is communicatively coupled to a corresponding implantable antenna (which may also be implemented by a coil and/or one or more wireless communication components) included within or otherwise connected to cochlear implant102. In this manner, stimulation parameters and/or power signals may be wirelessly and transcutaneously transmitted between sound processor202and cochlear implant102by way of a wireless communication link212.

In configuration200, sound processor202may receive an audio signal detected by microphone204by receiving a signal (e.g., an electrical signal) representative of the audio signal from microphone204. Sound processor202may additionally or alternatively receive the audio signal by way of any other suitable interface as described herein. Sound processor202may process the audio signal in any of the ways described herein and transmit, by way of headpiece206, stimulation parameters to cochlear implant102to direct cochlear implant102to apply electrical stimulation representative of the audio signal to the recipient.

FIG.3shows an exemplary configuration300of cochlear implant system100in which controller108is implemented by a combination of sound processor202and a computing device302configured to communicatively couple to sound processor202by way of a communication link304, which may be implemented by any suitable wired or wireless communication link.

Computing device302may be implemented by any suitable combination of hardware and software. To illustrate, computing device302may be implemented by a mobile device (e.g., a mobile phone, a laptop, a tablet computer, etc.), a desktop computer, and/or any other suitable computing device as may serve a particular implementation. As an example, computing device302may be implemented by a mobile device configured to execute an application (e.g., a “mobile app”) that may be used by a user (e.g., the recipient, a clinician, and/or any other user) to control one or more settings of sound processor202and/or cochlear implant102and/or perform one or more operations (e.g., diagnostic operations) with respect to data generated by sound processor202and/or cochlear implant102.

In some examples, computing device302may be configured to control an operation of cochlear implant102by transmitting one or more commands to cochlear implant102by way of sound processor202. Likewise, computing device302may be configured to receive data generated by cochlear implant102by way of sound processor202. Alternatively, computing device302may interface with (e.g., control and/or receive data from) cochlear implant102directly by way of a wireless communication link between computing device302and cochlear implant102. In some implementations in which computing device302interfaces directly with cochlear implant102, sound processor202may or may not be included in cochlear implant system100.

Computing device302is shown as having an integrated display306. Display306may be implemented by a display screen, for example, and may be configured to display content generated by computing device302. Additionally or alternatively, computing device302may be communicatively coupled to an external display device (not shown) configured to display the content generated by computing device302.

In some examples, computing device302represents a fitting device configured to be selectively used (e.g., by a clinician) to fit sound processor202and/or cochlear implant102to the recipient. In these examples, computing device302may be configured to execute a fitting program configured to set one or more operating parameters of sound processor202and/or cochlear implant102to values that are optimized for the recipient. As such, in these examples, computing device302may not be considered to be part of cochlear implant system100. Instead, computing device302may be considered to be separate from cochlear implant system100such that computing device302may be selectively coupled to cochlear implant system100when it is desired to fit sound processor202and/or cochlear implant102to the recipient.

FIG.4illustrates an exemplary configuration400in which controller108is implemented by a BTE unit that is worn by a recipient402. As shown, controller108includes a housing404that is configured to be worn behind and/or on top of an ear of recipient402. Housing404may house various components of controller108and is connected to a microphone406that is positioned at an ear canal entrance of recipient402. As shown, a user input button408and a status indicator410may be located on housing404.

As shown, headpiece206, which includes coil210, is coupled to controller108by way of a cable412. In some examples, headpiece206is removably coupled to housing404In certain examples, headpiece206may be configured to be magnetically held in place on the head of recipient402by a magnet of the cochlear implant.

In the configuration shown inFIG.4, headpiece206is positioned in or over a wound covering414(e.g., an adhesive bandage) that covers a wound created during an implant procedure in which cochlear implant102and/or electrode lead104are implanted within recipient402. Wound covering414may be placed over the wound for a period of time following an implant procedure. As described herein, in this configuration, controller108may be configured to operate in a therapeutic mode. When the wound has sufficiently healed and it is desired for controller108to operate in the cochlear implant interface mode, wound covering414may be removed and headpiece206may be placed directly on the head of the recipient402. Headpiece206may alternatively be located in an article of clothing or placed directly on the head over the wound while controller108operates in the therapeutic mode.

As described herein, controller108may be configured to selectively operate in at least two different modes. To illustrate,FIG.5shows exemplary operations that may be performed by controller108.

As shown, an input signal is received by a mode selection operation502. Mode selection operation502may be configured to select a mode of operation for controller108, such as between a therapeutic mode and a cochlear implant interface mode, based on the input signal.

In some examples, the input signal is provided by a user (e.g., the cochlear implant recipient). For example, the user may provide the input signal by pressing user input button408(which may be a volume selection button or any other suitable button on housing404), selecting an option in an application (e.g., a mobile application) associated with controller108, etc.

Alternatively, the input signal may be provided by a component of the cochlear implant system. For example, the input signal may be a feedback signal representative of a diagnostic operation configured to automatically determine when a particular mode of operation is needed.

As shown, if mode selection operation502selects a therapeutic mode, a therapeutic operation504outputs therapeutic electromagnetic pulses by way of coil210. The therapeutic electromagnetic pulses may be output by way of coil210in accordance with a therapeutic program stored in memory of controller108or otherwise accessed by controller108.

The therapeutic program may specify various parameters of the therapeutic electromagnetic pulses output by therapeutic program selection operation504. Exemplary parameters include, but are not limited to, an amplitude, a modulation depth, a pulse frequency, a pulse duration, and/or any other suitable parameter of the therapeutic electromagnetic pulses. For example, a therapeutic program may specify the following parameters: electromagnetic pulses configured to be applied 20-30 minutes per hour at a pulse frequency between 1000 Hz-5000 Hz and having pulse duration between 100 microseconds-2 milliseconds. Other therapeutic program parameter values may be used as may serve a particular implementation.

In some examples, a user may provide user input representative of a command to adjust a value for a parameter specified by a particular therapeutic program. The user input may be provided in any of the ways described herein. In response to the user input, controller108may adjust the value of the parameter. In this way, the user may adjust a parameter value to a value that is most efficacious for the recipient.

In some examples, controller108may determine a placement context of coil210and, in response, select the therapeutic program based on the determined placement context of coil210. For example, controller108may receive user input indicating the placement context of a coil (e.g., that the coil is placed directly over the wound, over or within a wound covering, etc.). Based on this input, controller108may select a particular therapeutic program and/or adjust one or more parameters (e.g., power levels) of a therapeutic program.

Alternatively, if mode selection operation502selects a cochlear implant interface mode, a cochlear implant interface operation506communicates with the cochlear implant by way of coil210. For example, in this mode, cochlear implant interface operation506may include receiving an audio signal and wirelessly transmit a command to the cochlear implant, by way of coil210, to direct the cochlear implant to apply electrical stimulation representative of the audio signal. In this mode, cochlear implant interface operation506may additionally or alternatively include wirelessly receiving data from the cochlear implant by way of coil210. For example, controller108may receive data indicative of changes in electrode impedances over time and/or any other type of back-telemetry data. Controller108may use this data to guide a manner in which controller108operates in the cochlear implant interface mode. For example, during a time period following an implant procedure, controller108may initially only receive data from the cochlear implant (and not transmit data to the cochlear implant directing the cochlear implant to apply electrical stimulation representative of audio signals to the recipient). As the recipient heals, a change in electrode impedance measurements may indicate that the recipient is ready to begin receiving stimulation representative of audio signals. Controller108may accordingly begin directing the cochlear implant to apply electrical stimulation representative of audio signals.

In some examples, controller108may be configured to concurrently operate in both the therapeutic mode and the cochlear implant interface mode. In these examples, controller108may concurrently apply therapeutic electromagnetic pulses and communicate with the cochlear implant. This concurrent operation may be beneficial in various post-operative scenarios.

In some examples, controller108may provide a visible and/or audible indication of a particular mode in which controller108is operating. For example, status indicator410may be implemented by a light emitting diode configured to indicate (e.g., by a particular color, blinking sequence, and/or any other suitable indication) when controller108is operating in a particular mode (e.g., a therapeutic mode or a cochlear implant interface mode). Status indicator410may be alternatively implemented in any suitable manner.

FIG.6illustrates an exemplary method600according to principles described herein. The operations shown inFIG.6may be performed by cochlear implant system100and/or any implementation thereof. WhileFIG.6illustrates exemplary operations according to embodiments described herein, other embodiments may omit, add to, reorder, and/or modify any of the operations shown inFIG.6.

In operation602, a controller operates in a therapeutic mode, by applying therapeutic electromagnetic pulses to a wound on a head of a recipient by way of a coil configured to be positioned over the wound, the therapeutic electromagnetic pulses configured to alleviate pain felt by the recipient while the wound heals. Operation602may be performed in any of the ways described herein.

In operation604, the controller receives a command to operate in a cochlear implant interface mode in which the controller communicates by way of the coil with a cochlear implant implanted within the recipient. Operation604may be performed in any of the ways described herein.

In operation606, the controller switches from the therapeutic mode to the cochlear implant interface mode. Operation606may be performed in any of the ways described herein.

FIG.7illustrates another exemplary configuration700in which a controller702is configured to apply therapeutic electromagnetic pulses by way of a coil704to a wound. Controller702and coil704may be similar to any of the controllers and coils described herein. For example, controller702may include a power source and may be configured to be portable and operate autonomously. Coil704may be housed within any suitable housing (e.g., a headpiece and/or any other type of housing).

In configuration700, coil704is configured to be positioned over a wound on a body and held in place on the body by a magnet706implanted within the body. The body may be a head and/or any other suitable body part of a person who has a wound. The wound may be the result of a medical procedure and/or caused by any other event or condition.

As shown, magnet706is included in an implantable assembly708that also includes an implantable device710. Implantable device708may be implemented by any type of implantable medical device as may serve a particular implementation. For example, implantable device708may be implemented by an implantable stimulator, a cochlear implant, a pacemaker, and/or any other type of device configured to provide any type of therapeutic benefit to a recipient.

In some examples, controller702may be configured to selectively communicate with implantable device710by way of coil704. For example, controller702may transmit data to and/or receive data from implantable device710.

In some examples, controller702may be configured to detect a presence of implantable device710(e.g., when coil704is placed on the body). In response to detecting the presence of implantable device710, controller702may initiate the therapeutic electromagnetic pulses and/or perform any other suitable operation.

In the preceding description, various exemplary embodiments have been described with reference to the accompanying drawings. It will, however, be evident that various modifications and changes may be made thereto, and additional embodiments may be implemented, without departing from the scope of the invention as set forth in the claims that follow. For example, certain features of one embodiment described herein may be combined with or substituted for features of another embodiment described herein. The description and drawings are accordingly to be regarded in an illustrative rather than a restrictive sense.