The present invention relates to neurostimulation, and more particularly to an implantable electrode interface that facilitates the upgrade, servicing and replacement of interconnected system power and signal generation componentry. The invention is particularly apt for auditory neurostimulation applications, and simplifies a recipient's migration from a semi-implantable system to a fully implantable auditory neurostimulation system.
The utilization of neurostimulation implant devices is ever-increasing. Such devices utilize a plurality of implanted electrodes that are selectively activated to affect a desired neuro-response, including sound sensation, pain/tremor management, and urinary/anal incontinence. By way of primary interest, auditory neurostimulation implant devices include auditory brainstem implant (ABI) and cochlear implant (CI) devices.
In the case of CI devices an electrode array is inserted into the cochlea of a patient, e.g. typically into the scala tympani so as to access and follow the spiral currature of the cochlea. The array electrodes are selectively driven to stimulate the patient's auditory nerve endings to generate sound sensation. In this regard, a CI electrode array works by utilizing the tonotopic organization, or frequency-to-location mapping, of the basilar membrane of the inner ear. In a normal ear, sound vibrations in the air are transduced to physical vibrations of the basilar membrane inside the cochlea. High frequency sounds do not travel very far along the membrane, while lower frequency sounds pass further along. The movement of hair cells, located along the basilar membrane, creates an electrical disturbance, or potential, that can be picked up by auditory nerve endings that generate electrical action pulses that travel along the auditory nerve to the brainstem. In turn, the brain is able to interpret the nerve activity to determine which area of the basilar membrane is resonating, and therefore what sound frequency is being sensed. By directing which electrodes of a CI electrode array are activated, cochlear implants can selectively stimulate different parts of the cochlea and thereby convey different acoustic frequencies corresponding with a given audio input signal.
With ABI systems a plurality of electrodes may be implanted at a location that bypasses the cochlea. More particularly, an array of electrodes may be implanted at the cochlea nucleus, or auditory cortex, at the base of the brain to directly stimulate the brainstem of a patient. Again, the electrode array may be driven in relation to the tonotopic organization of a recipient's auditory cortex to obtain the desired sound sensation.
As may be appreciated, in the case of either ABI electrodes or CI electrodes, audio signals (e.g. from a microphone) may be processed, typically utilizing what is referred to as a speech processor, to generating stimulation signals utilized to selectively drive the electrodes for stimulated sound sensation. Further, in both implant approaches a source of power may be included to power the stimulation signal generator.
To date, implant modules utilized in CI and ABI systems have largely displayed architectures with dedicated functionality in relation to the inclusion of on-board speech processors and/or power sources. Such an approach has frustrated the ready implementation of improved power sources (e.g. batteries having improved storage capabilities) and/or upgrades for speech processors (e.g. speech processors having enhanced processing capabilities), as well recipient migration from semi-implantable systems to fully-implantable systems.
In view of the foregoing, one objective of the present invention is to provide an implantable interface for neurostimulation electrodes that facilitates the replacement and/or upgrading of system power and/or stimulation signal generation componentry (e.g. stimulation processor).
Another objective of the present invention is to accommodate long-term implanted placement of a neurostimulator electrode array, and selective interconnection and disconnection thereof with other system componentry, wherein a recipient may initially utilize a semi-implantable system having one or more components located externally, and subsequently migrate to a fully-implantable system having all components implanted.
Yet another objective of the present invention is to reduce the size and complexity of implanted neurostimulation componentry, thereby simplifying surgical implant and servicing procedures, (e.g., neurostimulation componentry implanted within the auditory cortex of a recipient, at a spinal interface region of a patient, at a muscular interface of the urethra or anus region of a recipient, etc.).
One or more of the above objectives and additional advantages may be realized by an implantable electrode interface (e.g., an implanted hearing instrument interface) that comprises at least a first stimulation signal channel for receiving a first electrode stimulation signal (e.g. corresponding with an audio input signal) and a plurality of electrode signal channels electrically interconnected or interconnectable to a plurality of neurostimulation electrodes (e.g. an electrode array adapted for one of auditory brainstem and cochlear stimulation). The interface further includes a router electrically interconnected to the first stimulation signal channel and to the plurality of electrode signal channels, wherein the router is controllable to route the first electrode stimulation signal (e.g. on a dynamic basis) to different first successive sets of one or more of the plurality of electrode signal channels, wherein neurostimulation may be realized (e.g., auditory neuro stimulation).
The router may be adapted for receiving and directly routing the first electrode stimulation signal as an electrical current signal to the different first successive sets of one or more of the plurality electrode signal channels. In this regard, the router may be provided so that the stimulation current signal is routed without signal modification (e.g. without varying amplitude, pulse width, frequency or other current signal characteristics) and/or without signal buffering. Correspondingly, the implantable interface may avoid the inclusion of other stimulation signal generation componentry (e.g., speech processor) and power source componentry (e.g. a battery power source) that may be subject to replacement or upgrade servicing, and that otherwise consume space. In the later regard, the implantable interface may be of a relative small size, thereby facilitating semi-permanent positioning (e.g., on a cortical surface of a temporal bone of a recipient, within a mastoidectomy of a recipient or within a middle ear of a recipient adjacent to or near a cochlea of a recipient).
The noted stimulation signal generation and power source componentry may be remotely located from the implantable interface and operatively interconnected thereto. Further, direct current (DC) blocking componentry for blocking a DC portion of the first electrode stimulation signal may be located remotely from the implantable interface, thereby yielding further size reduction advantages at the implantable interface.
By way of example, in a fully implantable system arrangement the noted stimulation generation, power source and DC blocking componentry may be located in one or more implantable modules that are electrically interconnected to the implantable interface (e.g. via signal cable(s)). Such module(s) may be positioned at implant locations spaced, or remote, from the implantable interface where more space is available and where such modules are more accessible for replacement, servicing and upgrade procedures. For example, in auditory neurostimulation applications the module(s) may be positioned outside of the middle ear of a recipient (e.g. at a location on the cortical surface of the temporal bone near a mastoidectomy).
In a semi-implantable system arrangement for auditory neurostimulation, some or all of the noted componentry may be located externally, wherein an RF signal corresponding with an audio signal (e.g. an output signal from an externally located microphone) may be transcutaneously transmitted (e.g., between externally/internally located antennas (e.g., inductively coupled coils) and provided to the implantable interface. In such a system arrangement, a speech processor and/or a power source may be located either internally or externally (e.g. wherein a speech processor may process an audio signal to generate a stimulation signal that is transcutaneously transmitted as an RF signal).
The implantable interface may further include a biocompatible housing, wherein the router is sealably disposed within the housing. In turn, a first stimulation signal connector may be interconnected to the housing to define or at least partially define the first stimulation signal channel. The first stimulation signal connector may be adapted for selective interconnection of the router to and disconnection of the router from a first stimulation signal cable for carrying the first electrode stimulation signal. Such signal cable may be interconnected or interconnectable (e.g. via a plug-in connector) to an implanted speech processor for stimulation signal generation or to an implanted antenna (e.g., a coil) that is provided to transcutaneously receive an RF stimulation signal from an external antenna (e.g., a coil) that is interconnected to an externally-located stimulation signal generator (e.g., a speech processor).
The implantable interface may further include control logic, sealably disposed within the housing, for receiving a control signal and controlling the router in response thereto so as to route the first electrode stimulation signal to the different first successive sets of one or more of the plurality of electrode signal channels. By way of example, a digital processor and/or a plurality of gates may be employed for receiving a serial or multi-bit, digital control signal and for controlling the router in response thereto. The control signal may be generated by a control signal generator (e.g., a processor) that is remotely located from the implantable interface and operatively interconnected thereto. As may be appreciated, the stimulation signal generator and the control signal generator may be provided to an electrode to provide stimulation signals, and a control signal(s), respectively, in an operatively coordinated manner (e.g., in time correlation).
For example, in a fully-implantable system arrangement the control signal may be generated by a processor that is located in an implantable module that is electrically interconnected to the interface (e.g. via a signal cable). In one approach, such processor may be co-located with or otherwise defined by a speech processor utilized to generate the stimulation signal. Such module may be positioned at an implant location outside of the middle ear of a recipient. In a semi-implantable system arrangement the control signal may be generated by a processor that is externally located and transcutaneously transmitted as an RF signal via inductive coupling between externally/internally located coils and then directed to the implantable interface.
Relatedly, the implantable interface may include a control signal connector interconnected to the housing and adapted for selective connection of the processor to and disconnection of the processor from a control signal cable for carrying the control signal. Such signal cable may be interconnected or interconnectable (e.g. via a plug-in connector) to an implanted processor for control signal generation or to an implanted coil that is provided to transcutaneously receive an RF control signal from an external coil that is interconnected to an externally-located processor for control signal generation.
The implantable interface may further include a second stimulation signal channel for receiving a second electrode stimulation signal, wherein the second stimulation signal channel is electrically interconnected to the router. In turn, the router may be controllable to route the second electrode stimulation signal to different second successive sets of one or more of the plurality of electrode signal channels. In this regard, the second successive sets may be different than the first successive sets, wherein adjacent electrodes may be simultaneously driven by different stimulation signals to yield an intermediate sound frequency sensation (e.g. a sound sensation corresponding with a frequency that is between the frequencies corresponding with the driven, adjacent electrodes).
As may be appreciated, the implantable interface may include a plurality of stimulation signal channels for receiving a corresponding plurality electrode stimulation signals, wherein each of the plurality of stimulation signal channels is electrically interconnected to the router, and wherein the router is controllable to route each of the plurality stimulation signals to corresponding different successive sets of one or more of the plurality of electrode signal channels. In this regard, the router may be provided so that each of the plurality of stimulation signals may be routed as current signals free from modification of the signal characteristics thereof.
The implantable interface may further include a simple power circuit interconnected or interconnectable to a remotely located power source for receiving a power signal to power the router and/or the logic control noted hereinabove. In this regard, the power circuit may rectify an AC signal to DC power to supply the router, some additional componentry and optionally the stimulation current. The present invention further presents an inventive system for auditory neurostimulation. Such system comprises a stimulation signal generator for generating at least a first stimulation signal in response to an auditory signal; and an implantable interface having a router housed separately from said signal generator and electrically interconnected thereto, wherein the router is controllable to directly route said at least a first stimulation signal to different first successive sets of one or more of a plurality of electrode signal channels that are electrically interconnected or interconnectable to a plurality of electrodes for auditory neurostimulation.
In one aspect, the signal generator may be disposed in a bio-compatible, implantable module and the router may be disposed in a bio-compatible, implantable housing, wherein the implantable module and implantable housing may be electrically interconnected or interconnectable. By way of example, a cable line may operatively interconnect the signal generator disposed within the implantable module to the router disposed within the implantable housing. In this regard, the implantable housing may include a connector adapted for selective interconnection to and disconnection from a connector disposed on an end of the signal cable line that is interconnected to the implantable module. As may be appreciated, such an arrangement facilitates semi-permanent implant positioning of the implantable interface, while accommodating the removal and/or separate servicing of the speech processor disposed in the implantable module.
In a related aspect, the system may further include a power source disposed in a bio-compatible, implantable module, wherein the router may be disposed in a separate bio-compatible, implantable housing, and wherein the implantable module and implantable housing may be electrically interconnected or interconnectable. By way of example, a cable line may operatively interconnect the power source disposed within the implantable module to the router disposed within the implantable housing. In this regard, the implantable housing may include a connector adapted for selective interconnection to and disconnection from a connector disposed on the end of a signal cable line that is interconnected to the implantable module. In one embodiment the power source and stimulation signal generator may be disposed in the same implantable housing.
In an additional aspect, the system may further include a bio-compatible, implantable microphone that is interconnected or interconnectable to an implantable module having the signal generator disposed therewithin. The microphone may receive acoustic signals and output audio signals in response thereto for use by the signal generator in providing the electrode stimulation signal.
In yet a further aspect, the system may comprise an implantable antenna (e.g., coil) and an externally-locatable antenna (e.g., coil) that are adapted for wireless signal transmission) therebetween (e.g., via inductive coupling), wherein signals may be transcutaneously transmitted between the antennas. In conjunction with such an arrangement, the signal generator and a microphone may be located externally, wherein an audio signal output from the microphone may be utilized by the signal generator (e.g. a speech processor) to generate the stimulation signal. In turn, the external antenna may transmit the stimulation signal to the implanted antenna. The implantable interface may be interconnected to the implantable antenna for receipt of the stimulation signal. In conjunction with this approach, a power source may be externally located and interconnected to the microphone and signal generator.
In conjunction with the various system embodiments described above, the implantable interface may comprise one or more of the implanted interface features also described above. Further, the system may include a plurality of auditory neurostimulation electrodes electrically interconnected to the implantable interface in a manner that accommodates implanted positioning of the electrodes contemporaneous with positioning of the implantable interface. By way of example, the implantable interface may be integrated with a connector that is interconnected to one end of an electrode array. In turn, the integrated connector may be readily interconnected to and disconnected from a signal cable line(s) that is interconnected to an implantable simulation signal generator and power source.
As may be appreciated, the present invention further comprises an inventive method for driving a plurality of electrodes for auditory neurostimulation. The method includes the step of receiving at least a first electrode stimulation signal at an implantable electrode interface, and routing the first electrode stimulation signal at the interface to different successive sets of one or more of a plurality of electrodes for neurostimulation.
The routing step may include the step of controlling a router to dynamically define the different first successive sets of the plurality of electrodes. In turn, such controlling step may include processing a digital control signal. In one approach, the routing and processing steps may be completed at the implantable hearing instrument interface. In conjunction with such approach, the receiving step may include selectively interconnecting a first stimulation signal cable to the router at the implantable interface. In conjunction with the noted approach, the method may further include generating the first electrode stimulation signal at a processor that is located separate from the implantable electrode interface.
In conjunction with the control of the router, the router may be adapted to route the first electric stimulation signal as an electrical current signal to the different successive sets of one or more of the plurality of electrodes free from modification of the first electrode stimulation signal. In this regard, the routing step may be completed by utilizing the router to direct the first electrode stimulation signal to the different first successive sets of the plurality of electrodes.
In conjunction with the inventive method a second electrode stimulation signal may be received at the implantable interface and routed at the interface to different second successive sets of one or more of the plurality of electrodes. In this regard, the first electrode stimulation signal and second electrode stimulation signal may be employed to activate, in overlapping timed-relation first and second neurostimulation electrodes. For example, for auditory neurostimulation, the first and second electrodes may be located to stimulate nerve endings associated with first and second acoustic frequency stimulation, respectively, wherein sound sensation at an intermediate frequency (e.g. between the first and second frequencies) may be realized.
In a further aspect of the inventive method, the first electrode stimulation signal may be employed to drive the different first successive sets of one or more of a plurality of electrodes to effect neurostimulation, wherein a bodily generated electrical signal (e.g. generated by nerve endings in the cochlea of a recipient) received at one or more of the plurality of electrodes in response to the neurostimulation to generate a response signal. In turn, the response signal may be passed back through the implantable interface (either through the router, or digitally after having been digitized) for processing at a processor located separate from the implantable hearing instrument interface. In one approach, the response signal may be returned to a stimulation signal generator, wherein the response signal may be processed to measure the magnitude of neuroresponse to the electrode stimulation signal. In this regard, such measurements may be utilized in conjunction with fitting procedures in assessing appropriate signal characteristics to be employed in conjunction with the generation of electrode stimulation signals (e.g. setting the magnitude of pulses of comprising such signal).
In conjunction with the present invention, a further method is provided for auditory neurostimulation for an implant recipient. The method includes the steps of generating at least the first electrode stimulation signal implanted in a recipient at a first location (e.g. outside of the middle ear of a recipient in cochlear implant applications), and routing the first electrode stimulation signal at an implanted interface located at a second implanted location of the recipient (e.g. within the middle ear in a cochlear implant application) to different first successive sets of one or more of a plurality of electrodes for neurostimulation. In the later regard, the method may comprise a further step of positioning the plurality of electrodes at a third location within the recipient (e.g. within a cochlea of a recipient) in a cochlear implant application.
In one aspect, the inventive method may include the further step of locating a stimulation signal generator at said first location, wherein said locating said positioning steps are completed separately. In conjunction with this aspect the routing step may be completed utilizing a router located at the second location, wherein the method further includes electrically interconnecting said router and said signal generator after said positioning step.
In another aspect of the inventive method, the generating step may include the step of processing an audio signal utilizing an implanted speech processor. In conjunction with this aspect, the method may provide for receiving an acoustic signal at an implanted microphone to output an audio signal for use in the generating step. Further, the method may include the step of providing a power signal to a router to complete said routing step from an implanted power source.
In yet another further aspect, the generating step of the inventive method may include processing an audio signal at a stimulation signal generator externally located relative to a recipient. In this regard, the method may further include the step of receiving an acoustic signal at an externally located microphone or other audio source to generate the audio signal.
Additional aspects and advantages of the present will become apparent to those skilled in the art upon consideration of the further description that follows.
As shown in
For purposes of controlling the router 20, the implantable hearing instrument interface 10 may comprise control logic 40 that is electrically interconnected to at least one control signal channel 42 for receiving a control signal. The control logic 40 may be electrically interconnected to router 20 so as to use the control signal to control the routing of one or more electrode stimulation signals received via one or more stimulation signal channels 22 to one or more electrodes 30 via one or more electrode signal channels 24. In this regard, the control signal may comprise a digital signal and the control logic 40 may be a digital logic. That is, the digital logic may comprise gates that interpret serial or parallel data provided on the control signal channel 42 in order to control the stimulation to be provided, for example which electrode is selected for the current stimulation.
As shown in
The I/O processor and circuitry 50 may further comprise DC blocking componentry. For example, capacitors may be employed to prevent DC current from flowing while allowing AC current to flow. Alternatively, schemes using coulomb counters may be employed to ensure balanced current flow with no net DC current realized.
As further shown in
In one implementation, two stimulation signal channels 22, one control signal channel 42 and positive/negative voltage supply lines 82, 84 may be provided. In turn, five electrical conductor lines may be provided via multiple cables or a single cable having five lines and a five-pin connector for selective interconnection to a five pin connector at the interface unit 10.
In the embodiment illustrated in
In this regard, the embodiment shown in
Further, depending upon the number of stimulation signal channels 22 utilized, the embodiment may provide for simultaneous stimulation or pulsatile (e.g. non-simultaneous) stimulation. For example, under the control of the control signal logic, two electrodes may be selected to provide stimulation current such that unequal amounts of stimulation current are provided by the two electrodes (e.g., the current magnitudes are different). This bias in stimulation current will create an intermediate pitch perception for the patient between the two electrodes. The tonotopic location of the pitch perception can be controlled by the bias in the current between the two electrodes.
Additionally, the embodiment of
Reference is now made to
In particular,
Reference is now made to
Reference is now made to
It is again noted that, by virtue of the limited functionality provided by interface s unit 10, the interface unit 10 may be packaged with the connector as a single, integrated unit for selective interconnection with the connector 126 that is interconnected via cable 124 to the unit 50 schematically shown in
This application is a continuation of pending U.S. patent application Ser. No. 12/211,664, filed Sep. 16, 2008, entitled “IMPLANTABLE NEUROSTIMULATION ELECTRODE INTERFACE”, which claims priority to U.S. Provisional Application Ser. No. 61/054,385, filed May 19, 2008, entitled “IMPLANTABLE NEUROSTIMULATION ELECTRODE INTERFACE”, the entire disclosures of which are hereby incorporated by reference.
Number | Date | Country | |
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61054385 | May 2008 | US |
Number | Date | Country | |
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Parent | 12211664 | Sep 2008 | US |
Child | 13622096 | US |