U.S. patent application number 16/036382 was filed with the patent office on 2018-11-15 for low power cochlear implants.
The applicant listed for this patent is Massachusetts Eye and Ear Infirmary, Massachusetts Institute of Technology. Invention is credited to Anantha Chandrakasan, Konstantina Stankovic, Marcus Yip.
Application Number | 20180326212 16/036382 |
Document ID | / |
Family ID | 53180300 |
Filed Date | 2018-11-15 |
United States Patent
Application |
20180326212 |
Kind Code |
A1 |
Yip; Marcus ; et
al. |
November 15, 2018 |
LOW POWER COCHLEAR IMPLANTS
Abstract
The disclosure features systems for providing auditory signals
to a subject. The systems include a sensor front-end circuit
configured to be connected to an acoustic sensor and to convert
analog signals received from the acoustic sensor to digital
electric signals. The systems further include a sound processor
circuit configured to be connected to the sensor front-end circuit
and receive the electric signals provided by the sensor front end
circuit. The sound processor includes multiple filters that
spectrally decompose the received electrical signals into multiple
spectral channels during operation of the system. The multiple
spectral channels include at least a low frequency channel and a
high frequency channel and the sound processor circuit is
configured to operate the low frequency channel at a sample rate
lower than a sample rate of the high frequency channel.
Inventors: |
Yip; Marcus; (Cambridge,
MA) ; Chandrakasan; Anantha; (Belmont, MA) ;
Stankovic; Konstantina; (Boston, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Massachusetts Eye and Ear Infirmary
Massachusetts Institute of Technology |
Boston
Cambridge |
MA
MA |
US
US |
|
|
Family ID: |
53180300 |
Appl. No.: |
16/036382 |
Filed: |
July 16, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15037782 |
May 19, 2016 |
10022542 |
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PCT/US2014/067405 |
Nov 25, 2014 |
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16036382 |
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62012896 |
Jun 16, 2014 |
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61908237 |
Nov 25, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/025 20130101;
A61B 5/6878 20130101; A61N 1/36038 20170801; A61N 1/378 20130101;
A61B 2562/0204 20130101; A61B 2560/0219 20130101; A61B 5/1114
20130101 |
International
Class: |
A61N 1/36 20060101
A61N001/36; A61N 1/378 20060101 A61N001/378; A61N 1/02 20060101
A61N001/02 |
Claims
1. An implantable system for providing auditory signals to a
subject, the system comprising: a sensor front-end circuit
configured to be connected to an acoustic sensor and to convert
analog signals received from the acoustic sensor to digital
electric signals; and a sound processor circuit configured to be
connected to the sensor front-end circuit and receive the electric
signals provided by the sensor front end circuit; wherein: the
sound processor circuit comprises multiple filters that spectrally
decompose the received electrical signals into multiple spectral
channels during operation of the system; the multiple spectral
channels comprise at least a low frequency channel and a high
frequency channel; and the sound processor circuit is configured to
operate the low frequency channel at a sample rate lower than a
sample rate of the high frequency channel.
2. The system of claim 1, wherein during operation of the system,
the system is configured to send a clock signal and a control
signal into a gate, and use the output of the gate to clock-gate
filters of the spectral channels that are not used to provide the
auditory signals.
3. The system of claim 1 or claim 2, wherein the sensor front-end
circuit comprises: a charge amplifier circuit; a programmable gain
circuit; and an analog-to-digital converter (ADC) circuit.
4. The system of any one of claims 1 to 3, wherein the sound
processor circuit comprises a reconfigurable filter bank that
include the multiple filters, and the reconfigurable filter bank is
configured to change the number of spectral channels used to
provide auditory signals.
5. The system of claim 4, wherein the sound processor circuit is
reconfigurable to operate in 4-channel, 6-channel, or 8-channel
modes.
6. The system of claim 4, wherein power consumption of the sound
processor circuit is linear to the number of operating spectral
channels within 15% or less.
7. The system of claim 4, wherein the reconfigurable filter bank is
configured to adjust a bandwidth and center frequency of at least
one of the filters.
8. The system of claim 4, wherein the multiple filters are
configured to receive coefficients signals input that are quantized
to 8-bit precision.
9. The system of any one of claims 1 to 8, comprising a waveform
stimulator that comprises: a digital waveform interface circuit; an
electrode switch matrix; and a current source.
10. The system of claim 9, wherein the waveform stimulator is
configured to provide a waveform shape that is more
energy-efficient than a rectangular waveform with the same pulse
width.
11. The system of claim 9, wherein the waveform stimulator is
configured to provide a plurality of waveform shapes; and the
system comprises a calibration circuit configured to measure
hearing thresholds for the plurality of waveform shapes and select
a waveform shape having a low energy.
12. The system of claim 9, wherein the waveform stimulator is
configured to provide a waveform and to adjust the shape of the
waveform.
13. The system of claim 9, wherein the waveform stimulator
comprises only one current source.
14. The system of claim 9, wherein during operation, the system
consumes 600 .mu.W or less during normal conversation.
15. An implantable system for providing auditory signals to a
subject, the system comprising: a sound processor circuit
comprising multiple filters that spectrally decompose received
electrical signals into multiple spectral channels during operation
of the system; and a waveform stimulator comprising a digital
waveform interface circuit and an electrode switch matrix, wherein
the waveform stimulator is configured to receive output signals
from the multiple spectral channels and to generate an auditory
signal.
16. The system of claim 15, wherein the waveform stimulator
comprises a two-stage level shifter that connects the digital wave
form interface circuit and the electrode switch matrix.
17. The system of claim 15, wherein the waveform stimulator
comprises a single current source.
18. The system of claim 15, wherein the waveform stimulator
comprises a fast-settling current source.
19. The system of claim 15, wherein the waveform stimulator is
configured to generate a waveform shape which has an energy of 28%
or less than that of a rectangular waveform with the same total
pulse width.
20. A method for providing auditory signals to a subject, the
method comprising: determining a waveform using a heuristic
algorithm wherein the waveform shape comprises a cathodic phase and
an anodic phase; and each of the cathodic phase and anodic phase
differs in shape from a cathodic phase and an anodic phase in a
rectangular waveform.
21. The method of claim 20, comprising: generating an electrical
current pulse based on the determined waveform; and applying the
generated current pulse to stimulate auditory nerves of the
subject.
22. The method of claim 21, wherein the cathodic phase
exponentially decreases over time.
23. The method of any one of claims 20 to 22, wherein the waveform
shape is determined based on a parameter selected from a group
consisting of a phase width, duty cycle, and number of steps/width
of the heuristic algorithm.
24. The method of and one of claim 23, wherein the determined
waveform has an energy of 28% or less than that of a rectangular
waveform with a same total pulse width.
25. The method of claim 21, comprising: providing a plurality of
current pulses with different waveform shapes to the subject using
the waveform stimulator; measuring hearing thresholds for the
different waveform shapes; and selecting a waveform shape with a
lower energy for the measured threshold than another waveform
shape.
26. The method of any of claims 20 to 25, wherein the steps are
implemented before implanting the waveform stimulator to the
subject.
27. The method of any of claims 20 to 25, wherein the steps are
implemented after implanting the waveform stimulator to the
subject.
28. The method of claim 21, comprising: detecting vibration signals
using an acoustic sensor; generating electric signals by processing
the detected vibration signals using a sensor front-end circuit;
spectrally decomposing the electric signals using a sound processor
circuit to generate decomposed information; and using the
decomposed information to apply the generated current pulse to
multiple spectral channels for stimulating auditory nerves of the
subject.
29. The method of claim 28, wherein multiple spectral channels
receive differently scaled amplitudes of the wave form.
30. The method of claim 28, comprising reconfiguring the number of
spectral channels used to stimulate the auditory nerves.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 15/037,782, filed on May 19, 2016, which is a 371 U.S.
National Application of PCT/US2014/067405, filed on Nov. 25, 2014,
which claims priority from U.S. Provisional Application No.
61/908,237 filed on Nov. 25, 2013 and from U.S. Provisional
Application No. 62/012,896 filed on Jun. 16, 2014, the entire
contents of all of which are incorporated herein by reference.
TECHNICAL FIELD
[0002] This invention relates to cochlear implants.
BACKGROUND
[0003] Humans and other animals can suffer from conductive hearing
loss, where there is damage to the ossicular chain (bones of the
middle ear). Treatment options include medical or surgical
treatment, or various types of hearing aids and prosthetics.
Another form of hearing loss is sensorineural hearing loss, where
there is damage to hair cells in the cochlea (inner ear). In this
case, damage to the hair cells in the cochlea degrades the
transduction of acoustic information to electrical impulses in the
auditory nerve. Treatment options include hearing aids such as
cochlear implants that are devices used to stimulate the auditory
nerves.
[0004] Conventional cochlear implants typically include a
microphone to pick up sound. The microphone is fixed external to
the ear, which can raise social stigma and limit the usage of the
microphone in the shower or during water sports.
SUMMARY OF THE INVENTION
[0005] This disclosure describes techniques and systems to aid
hearing of subjects (e.g., human or animal subjects) using fully
implantable systems that include special circuits (e.g., sensor
front-end circuit, sound processor circuit, and waveform
stimulator) that enable the systems to run with extremely low power
requirements. In particular, the circuits can be manufactured on a
single chip that is used to deliver electrical stimulation to nerve
tissues in auditory systems of the subject. Circuits can operate at
low power to extend usage time of the chip before its power source
(e.g., battery) needs to be recharged. The chips can provide
waveforms (e.g., arbitrary waveforms) used to generate
energy-efficient stimulation pulses. Moreover, the small size of
the chips allows them to be used in fully implantable cochlear
implants for stimulating auditory nerves. The cochlear implants can
include an acoustic sensor (e.g., a microphone, an accelerometer,
or a piezoelectric sensor) mounted in the middle ear (e.g.,
contacting one of the ossicles, e.g., the malleus, e.g., at the
umbo, the incus, and the stapes, or contacting the oval window of
the cochlea) to efficiently detect incoming sound pressure in the
ear canal. Sound detected by the acoustic sensor is processed by
various circuits of the cochlear implants in a power-efficient
manner. The cochlear implants provide stimulation signals to
auditory nerves to aid hearing by the subject.
[0006] The techniques and systems disclosed herein enable extremely
low power operation of cochlear implants by utilizing power saving
techniques in various parts of the system. For example, certain
circuits (e.g., sound processor circuit) can operate at less than
1.0 volt (e.g., at 0.6 V) to operate close to its minimum energy
point of energy dissipation. As another example, the cochlear
implants can include a waveform stimulator that operates at
milli-Watt power consumption level while delivering energy above
the threshold for action potential (spike) initiation in a nerve
fiber. These results can be achieved by minimizing energy of the
stimulus by applying electrical pulses with a highly
energy-efficient waveform shape to the nerve fiber.
[0007] In one aspect, the disclosure features systems for providing
auditory signals to a subject. The systems include a sensor
front-end circuit configured to be connected to an acoustic sensor
and to convert analog signals received from the acoustic sensor to
digital electric signals. The systems further include a sound
processor circuit configured to be connected to the sensor
front-end circuit and receive the electric signals provided by the
sensor front end circuit. The sound processor includes multiple
filters that spectrally decompose the received electrical signals
into multiple spectral channels during operation of the system. The
multiple spectral channels include at least a low frequency channel
and a high frequency channel and the sound processor circuit is
configured to operate the low frequency channel at a sample rate
lower than a sample rate of the high frequency channel.
[0008] In some implementations, during operation of the system, the
system can be configured to send a clock signal and a control
signal into a gate, and use the output of the gate to clock-gate
filters of the spectral channels that are not used to provide the
auditory signals.
[0009] In some implementations, the sensor front-end circuit can
include a charge amplifier circuit, a programmable gain circuit,
and an analog-to-digital converter (ADC) circuit.
[0010] In some implementations, the sound processor circuit can
include a reconfigurable filter bank that include the multiple
filters, and the reconfigurable filter bank can be configured to
change the number of spectral channels used to provide auditory
signals. The sound processor circuit can be reconfigurable to
operate in 4-channel, 6-channel, or 8-channel modes. Power
consumption of the sound processor circuit can be linear to the
number of operating spectral channels within 15% or less. The
reconfigurable filter bank can be configured to adjust the
bandwidth and center frequency of at least one of the filters. The
multiple filters can be configured to receive coefficients signals
input that are quantized to 8-bit precision.
[0011] Additional implementations can include a waveform stimulator
that includes a digital waveform interface circuit, an electrode
switch matrix, and a current source. The waveform stimulator can be
configured to provide a waveform shape that is more
energy-efficient than a rectangular waveform with the same pulse
width. The waveform stimulator can be configured to provide a
plurality of waveform shapes. The systems can include a calibration
circuit configured to measure hearing thresholds for the plurality
of waveform shapes and select a waveform shape having a low energy.
The waveform stimulator can be configured to provide a waveform and
to adjust the shape of the waveform. The waveform stimulator can
include only one current source. During operation, the systems can
consume 600 .mu.W or less during normal conversation.
[0012] In another aspect, the disclosure features implantable
systems for providing auditory signals to a subject. The systems
include a sound processor circuit that includes multiple filters
that spectrally decompose received electrical signals into multiple
spectral channels during operation of the system. The systems
further include a waveform stimulator including a digital waveform
interface circuit and an electrode switch matrix. The waveform
stimulator is configured to receive output signals from the
multiple spectral channels and to generate an auditory signal.
[0013] In some implementations, the waveform stimulator can include
a two-stage level shifter that connects the digital wave form
interface circuit and the electrode switch matrix. The waveform
stimulator can include a single current source.
[0014] In some implementations, the waveform stimulator can include
a fast-settling current source. The waveform stimulator can be
configured to generate a waveform shape which has an energy of 28%
or less than that of a rectangular waveform with the same total
pulse width.
[0015] In another aspect, the disclosure features methods for
providing auditory signals to a subject. The methods include
determining a waveform using a heuristic algorithm where the
waveform shape includes a cathodic phase and an anodic phase, and
each of the cathodic phase and anodic phase differs in shape from a
cathodic phase and an anodic phase in a rectangular waveform.
[0016] In some practices, the methods can include generating an
electrical current pulse based on the determined waveform, and
applying the generated current pulse to stimulate auditory nerves
of the subject. The cathodic phase can exponentially decrease over
time.
[0017] In some implementations, the waveform shape can be
determined based on a parameter selected from a group consisting of
a phase width, duty cycle, and number of steps/width of the
heuristic algorithm. The determined waveform can have an energy of
28% or less than that of a rectangular waveform with a same total
pulse width.
[0018] In some practices, the methods can include providing a
plurality of current pulses with different waveform shapes to the
subject using the waveform stimulator, and measuring hearing
thresholds for the different waveform shapes. The methods can
include selecting a waveform shape with a lower energy for the
measured threshold than another waveform shape.
[0019] In some implementations, the method steps described in the
preceding paragraphs are implemented before implanting the waveform
stimulator to the subject.
[0020] In some implementations, the method steps described in the
preceding paragraphs are implemented after implanting the waveform
stimulator to the subject.
[0021] Additional implementations can include detecting vibration
signals using an acoustic sensor, and generating electric signals
by processing the detected vibration signals using a sensor
front-end circuit. The methods can include spectrally decomposing
the electric signals using a sound processor circuit to generate
decomposed information, and using the decomposed information to
apply the generated current pulse to multiple spectral channels for
stimulating auditory nerves of the subject. Multiple spectral
channels can receive differently scaled amplitudes of the wave
form. The methods can include reconfiguring the number of spectral
channels used to stimulate the auditory nerves.
[0022] The techniques and systems disclosed in this specification
provide numerous benefits and advantages (some of which can be
achieved only in some of the various aspects and implementations)
including the following. Given the new systems, the cochlear
implants can be implemented on a single chip that is fully
implantable (including the acoustic sensor) inside the ear of a
subject. This can be aesthetically pleasing and convenient for the
subject, because the cochlear implants can be fully implantable and
will not be seen external to the ear. In addition, a subject can
use the cochlear implant in the shower or during water sports
without damage to the implant.
[0023] In general, the disclosed techniques can be used to
significantly reduce the power consumption of a cochlear implant in
a variety of ways. For example, the cochlear implants can operate
at overall power consumption of 600 .mu.W or less while stimulating
auditory nerves at their threshold of action potential. A waveform
stimulator of the implant can generate arbitrary waveforms that
have shapes that minimize the energy needed to stimulate auditory
nerves. In some cases, various parameters (e.g., shape, pulse
duration, and duty cycle) of the waveform can be fine-tuned for a
specific subject or environment in real-time.
[0024] Because the energy needed to stimulate the nerves takes up a
significant portion of the power consumption of the cochlear
implant, power reduction of the waveform stimulator can enhance the
operation time of the implant for a given capacity of battery. As
another example, the cochlear implant can include a sound processor
circuit that utilizes a multi-rate reconfigurable filter bank. The
filter bank can operate different spectral channels at different
sample frequencies that reduce power consumption of the sound
processor circuit. Moreover, the reconfigurability of the filter
back allows selection of the optimum number of spectral channels
for different subjects so that unnecessary channels can be turned
off. In some cases, when available battery level is low, the
cochlear implant can be switched to an operation mode using a lower
number of channels to save battery power until the battery is
recharged. These approaches lead to power savings of the cochlear
implant.
[0025] Unless otherwise defined, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this invention belongs. Although
methods and materials similar or equivalent to those described
herein can be used in the practice or testing of the present
invention, suitable methods and materials are described below. All
publications, patent applications, patents, and other references
mentioned herein are incorporated by reference in their entirety.
In case of conflict, the present specification, including
definitions, will control. In addition, the materials, methods, and
examples are illustrative only and not intended to be limiting.
[0026] Other features and advantages will be apparent from the
following detailed description, and from the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] FIG. 1 is a schematic of a cross section of a human ear.
[0028] FIG. 2 is a schematic block diagram of components in a low
power cochlear implant as described herein.
[0029] FIG. 3 is a schematic of an example of a circuit diagram of
one embodiment of a low power cochlear implant.
[0030] FIG. 4A is a schematic of an example of an acoustic sensor
in the form of a piezoelectric cantilever design.
[0031] FIG. 4B is a schematic of an example of a sensor front-end
circuit.
[0032] FIG. 5A is a schematic of an example of a sound processor
circuit.
[0033] FIG. 5B is a schematic showing three different types of
Finite Impulse Response (FIR) filters used in a filter bank.
[0034] FIG. 6 is a schematic of an example of a waveform stimulator
circuit.
[0035] FIGS. 7A and 7B are schematics of an example of an electrode
switch matrix.
[0036] FIG. 7C is a schematic of an example a waveform of an
electrical pulse.
[0037] FIG. 7D is a schematic of an example of a current source
circuit.
[0038] FIG. 8 is a schematic of a conventional waveform.
[0039] FIGS. 9A-C are schematics of a computational model used for
calculating a trigger of action potential for various stimulus
waveforms.
[0040] FIGS. 10A-C are plots showing an evolution of an example of
a waveform and its energy.
[0041] FIG. 11 is a flow chart depicting operations for one example
of stimulating auditory nerves of a subject using a cochlear
implant as described herein.
[0042] FIG. 12 is a representation of a manufactured
fully-implantable cochlear implant chip.
[0043] FIGS. 13A-D are images showing a demonstration of the
reconfigurability in the number of channels of a sound processor
circuit.
[0044] FIGS. 14A-C are plots of energy efficient waveforms for
various pulse width.
[0045] FIGS. 15A-G are representations of various waveforms
generated by an electronic processor and their energies.
[0046] FIGS. 16A-C are a series of plots of measured power
consumption for generating pulses of various waveforms.
[0047] FIG. 17 is a flow chart depicting exemplary operations for
designing a circuit that operates from a power supply providing 1.0
V or less.
DETAILED DESCRIPTION
[0048] The methods and systems described herein can be implemented
in many ways. Some useful implementations are described below. The
scope of the present disclosure is not limited to the detailed
implementations described in this section, but is described in
broader terms in the claims.
[0049] Anatomy of the Ear
[0050] The ears of subjects, e.g., humans and animals such as
mammals, have a similar anatomy. The human ear is an auditory
system that transforms acoustical energy to electrical energy that
is applied to the auditory nerve. FIG. 1 is a schematic of a cross
section of a human ear 100, which is separated into the outer ear,
middle, and inner ear.
[0051] The outer ear includes the pinna 102, ear canal 104, and
tympanic membrane 106 (ear drum). Umbo 108 is the most depressed
part of the tympanic membrane when viewed from within the ear
canal. Sound pressure waves enter the pinna 102 and vibrate the
tympanic membrane 106, which motion couples to the ossicular chain
that includes three small bones called the malleus 110, incus 112,
and stapes 114 of the middle ear. The motion of the stapes 114 on
the oval window of the cochlea moves fluid inside the cochlea of
the inner ear. Motion of the hair cells of the cochlea due to the
motion of the cochlear fluid generates electric pulses to the
auditory nerve, which the brain interprets as sound. The length of
the hair cells is shortest near the oval window (base) of the
cochlea and increases toward the round window at the end (apex) of
the cochlea. Higher frequency waves excite the hair cells near the
base and lower frequency waves excite hair cells at the apical end
of the cochlea as the resonant frequency of each hair cell depends
on its length.
[0052] Conductive hearing loss occurs when there is damage to the
ossicular chain, while sensorineural hearing loss occurs when there
is damage to the hair cells in the cochlea. In the latter case, a
cochlear implant can be used to generate electric pulses that are
applied to the auditory nerve to help restore hearing. This
specification relates to cochlear implants to aid hearing.
[0053] Devices
[0054] FIG. 2 is a schematic of a cochlear implant 200 including
components 202-212. Acoustic sensor 202 (e.g., a microphone, an
accelerometer, or a piezoelectric sensor) can be mounted to contact
one of the ossicles, e.g., on the malleus, such as on the umbo of
the malleus. As used herein, an acoustic sensor is any device that
can convert sound or vibration into an electrical signal, e.g., an
analog or digital electrical signal. The acoustic sensor 202
detects the motion of the umbo and generates electrical signals,
which are received by sensor front-end circuit 204. The sensor
front-end circuit 204 can amplify the received electrical signals
and can convert analog signals into digital signals. As a result,
the sensor front-end circuit 204 can send digital electrical
signals to sound processor circuit 206. In some implementations,
acoustic sensor 202 can provide a digital electrical signal. In
this case, the sensor front-end circuit 204 may not need to amplify
and convert the analog signals received from the acoustic sensor
202 into digital signals.
[0055] The sound processor circuit 206 spectrally decomposes the
received signals into multiple channels. Different channels
represent different spectral ranges of sound perceived by a
subject. The outputs of the channels are sent to waveform
stimulator 208 to control electric pulses delivered by electrode
array 210. The waveform stimulator 208 generates waveforms that are
applied to the electrode array 210 as electric pulses through an
electrode switch matrix. In this way, the electric pulses can
stimulate the auditory nerve of the subject according to the
detected sound and processed electrical signals. Battery 212 can
provide power to various components (e.g., sensor front-end circuit
204, sound processor circuit 206, waveform stimulator 208) of
cochlear implant 200. Detailed implementations of various
components are described in the following sections.
[0056] FIG. 3 is a schematic of one example of cochlear implant
200. In this example, digital-to-analog converter (ADC) 305 (e.g.,
successive approximation or "SAR" ADC) receives signals from sensor
front-end circuit 204 and sends the converted signal to sound
processor circuit 206. In some implementations, the sensor-front
end circuit 204 includes the ADC 305.
[0057] The sound processor circuit 206 can include a variety of
steps for processing the received signals. For example, the
received signals pass through a filter (e.g., a 3-stage decimation
filter 312 to down-sample an input clock signal into lower sample
rates) and are spectrally decomposed by filter bank 314 so as to
form multiple channels. Following the filter bank 314, the envelope
of each channel is extracted by envelope extractor 316. For
example, the extractor 316 can extract the envelope by passing
respective signals through a rectifying diode and a low-pass
filter. Then signals of each channel can be compressed by
compressor 318. This is to take account of the loudness growth
function of electrical hearing that describes the linear
relationship between acoustic sound intensity in decibel (dB) sound
pressure level (SPL) and electric stimulation intensity in amperes.
Optionally, the dynamic range of signals in each channel can
adjusted by fitting circuit 320 to match individual threshold (THR)
and most-comfortable-level (MCL) specific to a subject.
[0058] Detailed description of various components of cochlear
implant 200 is described in the following sections.
[0059] Acoustic Sensor
[0060] An acoustic sensor 202 is small enough to be implanted in
the middle ear and to replace conventional microphones installed
external to the ear. The acoustic sensor 202 is small and light
weight so that the presence of the acoustic sensor 202 does not
dampen the natural frequency response of the middle ear. In other
words, the mass-loading by the sensor is designed to be negligible
if the sensor is implanted to contact one of the bones in the
ossicular chain so as to avoid performance reduction of the
ossicular chain. Moreover, the acoustic sensor 202 can be
mechanical impedance matched to effectively pick up sound waves by
vibration of the bones, e.g., the umbo of the malleus. The acoustic
sensor 202 can also be implanted beneath skin portions away from
the ear, in a location to avoid unwanted pickup of vibrations due
to talking or chewing.
[0061] The acoustic sensor 202 has the sensitivity and dynamic
range needed for hearing. This is taken into consideration in the
design of the acoustic sensor 202 and sensor front-end circuit 204.
Moreover, the electrical impedance between the acoustic sensor 202
and the sensor front-end circuit 204 can be matched so the sensor
front-end circuit 204 can efficiently receive electrical currents
from the acoustic sensor 202, thereby increasing the sensitivity.
In some implementations, the acoustic sensor 202 can detect sounds
from 300 Hz to 10 kHz over a 50 dB dynamic range from 40 to 90 dB
SPL. In some implementations, a pre-emphasis of +6 dB/octave can be
embedded in the output of acoustic sensor 202. Generally, the
acoustic sensor 202 can detect frequencies from 10 Hz to 60 kHz or
more (e.g., 80 kHz or more, 120 kHz or more, 160 kHz or more), and
electrical signals with such frequencies can be processed by a
cochlear implant to generate stimulus pulses corresponding to these
frequencies.
[0062] Acoustic sensor 202 can be designed to have a noise floor
level to provide sufficient sensitivity and a mass that does not
significantly deter the function of the umbo. To determine the
noise floor level and mass, laser Doppler vibrometery (LDV) can be
used to measure the vibration velocity of the location to which the
acoustic sensor will be mounted, e.g., on the umbo. For example,
for pure tones from 0.1 to 19 kHz sound input, the integrated noise
is about 10 .mu.g.sub.rms (1 g=9.8 m/s.sup.2) over 8 kHz bandwidth
and a minimum detectable sound of 40 dB SPL leads to a noise floor
of about 0.1 .mu.g.sub.rms/sqrt(Hz). The noise of acoustic sensor
202 can be lower than this noise floor of 0.1
.mu.g.sub.rms/sqrt(Hz). The vibration velocity of the umbo can be
measured by varying the mass of metal, e.g., copper disks attached
to the umbo. By determining the mass that negligibly affects the
umbo vibration, the mass-limit of the acoustic sensor 202 can be
identified, for example, to be less than 20 mg.
[0063] In some implementations, acoustic sensor 202 can be an
accelerometer that detects motion of a middle ear bone, e.g., the
malleus, for example, the umbo of the malleus. The accelerometer
can be small enough to be implanted in the middle ear, and directly
or indirectly (through a lever) contact the ossicle. For example,
accelerometers can include piezoelectric, piezoresistive, or
capacitive components that convert mechanical motion to an
electrical signal. In some implementations, the accelerometer can
detect tilt and/or vibration. Accelerometers can include
SQ-SEN.RTM. models, SQ-MIN.RTM. models, ADXL362.RTM., or
LIS3DH.RTM.. Accelerometers can include micro electro-mechanical
(MEMS) devices having a cantilever beam. Examples of accelerometers
are described in D. J. Young, et al, MEMS Capacitive
Accelerometer-Based Middle Ear Microphone, IEEE Trans. on Bio.
Eng., vol. 59, p. 3283 (2012) and U.S. patent application Ser. No.
13/529,011 to T. M. Beckerle, filed on Jun. 21, 2012 and published
on Jan. 17, 2013.
[0064] In some other implementations, acoustic sensor 202 can be a
microphone that directly converts vibrating sound pressure in air
to an electrical signal. The microphone can be implanted beneath
the skin close to the ear. The microphone can be wired to circuits
that process the electrical signal provided from the microphone.
Examples of microphones are described in H. A. Jenkins, et al, U.S.
Phase I Preliminary Results of Use of the Otologics MET
Fully-Implantable Ossicular Stimulator, Otol.-Head and Neck
Surgery, 137, 206 (2007) and U.S. Pat. No. 7,346,397 to D. Money,
filed on Jun. 29, 2001.
[0065] In some implementations, acoustic sensor 202 can be a
piezoelectric sensor. For example, the acoustic sensor 202 can be
made from Lead-Zirconate-Titanate (PZT). The acoustic sensor 202
can be made from two or more layers of piezoelectric materials. In
some implementations, the acoustic sensor 202 can be made from a
single layer of piezoelectric material.
[0066] FIG. 4A is a schematic of an example of the acoustic sensor
202 made from piezoelectric material, which is clamped on one end
like a cantilever. The other end can be placed in contact with a
middle ear ossicle, such as the incus, stapes, or malleus, e.g.,
with the umbo of the malleus. When the umbo vibrates, the umbo
exerts a force F on the sensor as illustrated in FIG. 4A. As the
force F bends the acoustic sensor 202, an open circuit voltage
V.sub.OC is generated across two terminals 411 and 413 of the
acoustic sensor 202 according to equation 1 (Eq. (1)):
V OC = g 31 ( 3 L 2 Wt ) F = g 31 ( 3 L 2 Wt ) mA U ( f ) P EC ( 1
) ##EQU00001##
where W, L, and t are dimensions of sensor depicted in FIG. 4A.
g.sub.31 is the piezoelectric transverse voltage coefficient, which
for example, can be about -11.6.times.10.sup.-3Vm/N for typical
piezoelectric materials. Force F applied by the umbo can be
calculated from the ear canal pressure P.sub.EC according to the
relation F=mA.sub.U(f)P.sub.EC, where m is the mass of acoustic
sensor 202 and A.sub.U(f) is the umbo acceleration normalize by
P.sub.EC. Typically, A.sub.U(f) is about 1 to 2 m/s.sup.2/Pa.
[0067] In the example illustrated in FIG. 4A, the acoustic sensor
202 has W=3 mm, L=3 mm, and t=0.5 mm. Using density 7800 kg/m.sup.3
of the PZT, mass m of the acoustic sensor 202 can be calculated to
provide V.sub.OC ranging from 0.7 .mu.V.sub.rms to 2.4
.mu.V.sub.rms for sound pressure levels from 40 to 90 dB SPL. Such
range of V.sub.OC is sufficiently larger than noise so as to be
detected by sensor front-end circuit 204. Generally, the acoustic
sensor 202 can be cut in other dimensions and shapes with selected
mass than described in relation to FIG. 4A. In some
implementations, wires connected to the acoustic sensor 202 can be
shielded and/or the sensor front-end circuit 204 can be placed
close to the sensor with a wire connection length of 10 mm or less
(e.g., 15 mm or less, 20 mm or less), thereby reducing any
electromagnetic interference affecting the acoustic sensor 202.
[0068] In some implementations, acoustic sensor 202 can be fixed
(e.g., using a tissue-safe adhesive) on a rigid rod (e.g., a
needle-like rod). When the acoustic sensor 202 includes a
piezoelectric sensor, a support can be used to fix one end of the
piezoelectric sensor to a bony wall within the middle ear, while
the other end of the piezoelectric sensor is fixed to the rod. The
rod can directly contact the ossicle, and the vibration of the
ossicle is transferred through the rod to the acoustic sensor 202.
In this case, the acoustic sensor 202 is not directly in contact
with the ossicle. The rod can be a thin bar made from metal,
plastic, or ceramic that is sufficiently rigid to effectively
transfer vibrations of the ossicle to the sensor.
[0069] Acoustic sensor 202 can have numerous advantages such as
having a small size, mass, customizability (by being cut in any
shape and size), low-power operation, and high sensitivity required
for detecting sound pressures less than 60 dB SPL. Unless the
sensor includes any metallic parts, the acoustic sensor 202 can
remain implanted in the subject, and would be safe during magnetic
resonance imaging (MRI).
[0070] Sensor Front-End Circuit
[0071] FIG. 4B is a schematic of an example of sensor front-end
circuit 204 that operates from a 1.5 V analog power supply, and
includes three stages and an analog-to-digital converter (ADC) 305.
Stage 1 includes a charge amplifier 402 that is electrically
connected to acoustic sensor 202. Stage 2 includes a programmable
gain circuit 404, and stage 3 includes a single-ended to
differential ADC driver circuit 406. The sensor front-end circuit
204 provides a mid-rail reference voltage V.sub.ref,PZ to bias one
terminal (e.g., terminal 413) of acoustic sensor 202. The other
terminal (e.g., terminal 411) of acoustic sensor 202 is connected
to an input of the charge amplifier circuit 402 as shown in FIG.
4B. The ADC driver circuit 406 provides analog level conversion
from V.sub.ref,PZ=750 mV down to V.sub.adc,cm=300 mV, which is the
input common-mode for ADC 305. In an example, the ADC 305 can be a
differential 16 kS/s 9-bit SAR ADC operating from a 0.6 V power
supply.
[0072] In stage 1, charge amplifier circuit 402 can include
resistors R.sub.1i and R.sub.1f, variable capacitor C.sub.1f, and
an operational amplifier (op-amp), e.g., as shown in FIG. 4B.
Resistor R.sub.1i can be a variable resistor with a resistance
value ranging from 1 to 100 k.OMEGA.. Acoustic sensor 202 can
include a capacitor C.sub.p, which can have values from 0.2 nF to 3
nF. Accordingly, C.sub.1f can be a tunable capacitor with values
small enough (e.g., 6-66 pF) to provide sufficient gain for small
values of C.sub.p, and large enough to limit the gain for large
values of C.sub.p so as not to saturate the charge amplifier
circuit 402 response at large sound pressure levels. C.sub.1f can
be a feedback capacitor being a 3-bit switched-capacitor and is
non-uniformly spaced to provide programmable mid-band gain in 3 dB
steps. R.sub.1f is constrained by the minimum value of C.sub.f and
is set to 88.4 M.OMEGA.. R.sub.1i can be implemented as a 4-bit
switched-resistor logarithmically spaced from 1 k.OMEGA. to 100
k.OMEGA..
[0073] For the acoustic sensor 202 described in relation to FIG. 4A
with W=3 mm, L=3 mm, and t=0.5 mm, the minimum signal is about 3
.mu.V.sub.rms at 40 dB SPL, which sets an upper bound of noise of
the sensor front-end circuit 204. The noise from R.sub.1i and
R.sub.1f are reduced for larger values of C.sub.p, and the noise
from the op-amp can be independent of C.sub.p. The noise from
R.sub.1f is negligible because of its relatively large value of
88.5 M.OMEGA. than R.sub.1i. For C.sub.p=0.5 nF and 3 nF as
examples, the total noise of the charge amplifier circuit 402 is
about 2.5 .mu.V.sub.rms and 1.7 .mu.V.sub.rms, respectively.
[0074] The op-amp in the charge amplifier circuit 402 can be a
folded-cascode op-amp with source-degenerated bias transistors to
improve noise performance. Input devices of the op-amp can be
p-type metal-oxide-semiconductor (PMOS) transistors with large pair
dimensions to limit 1/f noise so that the op-amp noise is dominated
by thermal noise. The op-amp utilizes a common-source stage to
increase its open loop gain, and the output of the op-amp is a PMOS
source-follower with low output impedance to drive the resistive
load of stage 2 of the sensor front-end circuit 204.
[0075] For stage 2, the programmable gain circuit 404 can include
several resistors, a capacitor, and op-amp, e.g., as shown in FIG.
4B. In this example, R.sub.2ia and R.sub.2ib are each 0.5 M.OMEGA.,
R.sub.2f is a switch-resistor that is logarithmically spaced
between 1.1 and 30 M.OMEGA. to provide programmable gain in 6 dB
steps from 0.83 dB to 29.5 dB. Capacitor C.sub.2f has a value
816fF. In some implementations, the programmable gain circuit 404
is a 2-pole programmable gain-amplifier (PGA) to provide gain in
addition to that of charge amplifier circuit 402. Op-amp of the
programmable gain circuit 404 is a cascaded current mirror op-amp
to achieve high gain. Its output stage is a PMOS source-follower to
provide low output impedance to drive the resistive load by stage 3
of the sensor front-end circuit 204. The noise of the programmable
gain circuit 404 can decrease with larger values of R.sub.2f.
[0076] Stage 3 of the sensor front-end circuit 204 includes an ADC
driver circuit 406, e.g., as shown in FIG. 4B. In this example, the
ADC driver circuit 406 is a single-ended to differential amplifier
that is configured to drive the input capacitance of ADC 305, which
is about 480 fF. This can be achieved by implementing a series
connection of a non-inverting amplifier (e.g., gain=2) and an
inverting amplifier (e.g., gain=-1). In this way, the ADC driver
circuit 406 can provide an additional gain of 12 dB (4V/V). The two
op-amps used in stage 3 are two-stage op-amps that leverage the
cascoded current mirror stage of the op-amp in the programmable
gain circuit 404, with a high-power common-source output stage to
drive the capacitance of ADC 305. Because the ADC 305 operates from
a low supply voltage of 0.6 V, stage 3 can provide analog level
conversion from V.sub.ref,PZ=750 mV to the ADC input common-mode of
V.sub.adc,cm=300 mV. This can be achieved by biasing of the
feedback network of 10 M.OMEGA. resistors.
[0077] Sound Processor Circuit
[0078] ADC 305 output signals to be received and processed by sound
processor circuit 206. Generally, the sound processor circuit 206
can process signals to generate information used to provide
electric pulses to a multi-electrode array for stimulating the
auditory nerve at different locations. Different electrodes can
stimulate different locations so as to emulate the tonotopic
structure of the cochlea. Such an approach can be referred as a
multi-channel sound processing because the process generates
signals for multiple-channels, where each channel corresponds to
one electrode of the multi-electrode array. The multi-channel sound
processing can utilize, but not limited to, envelope-based
strategies, n-of-m strategies, and feature-based strategies.
[0079] In this specification, a Continuous Interleaved Sampling
(CIS) strategy is utilized as an example. CIS is an example of an
envelope-based strategy. In implementing a CIS strategy, each
electrode delivers biphasic current pulses in a time-interleaved
(non-overlapping) manner relative to other electrodes to minimize
channel-to-channel interaction in the cochlea. For a specific
electrode, a large amplitude of the current pulse (also referred to
as "auditory signals" herein) corresponds to a large amount of
energy delivered to the frequency band represented by that specific
electrode.
[0080] An arrangement of a sound processor circuit 206 utilizing a
CIS strategy was described in relation to FIG. 3. As mentioned,
detected signal can pass through filter bank 314 that are
logarithmically spaced band-pass filters. Each filter in filter
bank 314 can correspond to a different spectral channel. An
envelope of signals passing each channel can be extracted by
extractor 316 by rectification and low-pass filtering. Then the
envelope can be compressed by a non-linear function (e.g.,
logarithmic function) by compressor 318 to scale the dynamic range
of acoustic signals to the dynamic range of electrical hearing. The
signals processed by sound processor circuit 206 can be used to
modulate the amplitude of a train of interleaved current pulses
applied to the electrodes. A high rate (e.g., several 100's to
1000's of pulses/s) of stimulation can be achieved with minimal
simultaneous channel interaction. This can be advantageous because
a high rate of stimulation can preserve temporal information in
speech.
[0081] FIG. 5A is a schematic of an example of a sound processor
circuit 206. In this example, the sound processor circuit 206 is
operated by a 0.6 V power supply and has many programmable
features. The techniques described herein can allow the sound
processor circuit 206 to operate at ultra-low power of 1.90 .mu.W
or less and be reconfigurable to balance power and performance with
patient specific fitting capabilities. Such features lead to power
savings of the overall cochlear implant.
[0082] Referring to the example shown in FIG. 5A, electric signals
from ADC 305 are input into the sound processor circuit 206 at 16
kHz. A clock signal f.sub.s is input at 16 kHz. A three-stage
decimation filter 312 down-samples the clock signal into sample
rates of 8 kHz, 4 kHz, and 2 kHz. Accordingly, different samples
rates can be set for different channels depending on the
configuration of the sound processor circuit 206.
[0083] The sound processor circuit 206 can spectrally decompose the
input signals from the ADC 305 with a logarithmically spaced filter
bank 314 represented as channels A-H in FIG. 5A. Channels A-H
represents low to high frequency channels, respectively. In this
example, channels A, B, C, E, F, and G are reconfigurable. The
number of channels can be reconfigured between 8-, 6-, and
4-channel modes to enable a power-performance tradeoff. For
example, subjects (e.g., human patients) can go through a speech
recognition test. For some subjects, 4 channels that provide
electric pulses to corresponding 4 electrodes may be sufficient for
a good speech recognition score, and additional channels may not
significantly improve speech recognition. In this case, any
channels in excess of 4 channels can be turned off to save
operation power of the sound processor circuit 206 at the expense
of some resolution of the perceived sound. For some subjects, 6
channels may be sufficient for good speech recognition, and any
channels in excess of 6 channels can be turned off to save
power.
[0084] The number of channels of 4, 6, and 8 are only examples, and
any other number of channels can be implemented to fit the needs of
different subjects. However, it appears that 8 channels may be more
than sufficient in the embodiments described herein. The channels
can be logarithmically spaced to emulate the tonotopic structure of
hearing.
[0085] The sound processor circuit 206 can be configured to operate
in 4-, 6-, or 8-channel modes by input signal with 2 bits sel_chan
(1:0) sent from a Serial Programming Interface (SPI). For example,
when input signal sel_chan(1:0) is data bits 00, the sound
processor circuit 206 can operate in 4-channel mode. When input
signal sel_chan(1:0) is data bits 01, the sound processor circuit
206 can operate in 6-channel mode. When input signal sel_chan(1:0)
is data bits 10, the sound processor circuit 206 can operate in
8-channel mode. The SPI can be included in cochlear implant 200. As
the number of channels selected to provide electric pulses to
electrodes change, a different subset of channels are selected from
channels A-H. In some implementations, bandwidth and center
frequency of each filter in filter bank 314 is changed by using FIR
filters with 3 levels of reconfigurability in both the coefficients
and number of taps of each filter. In certain implementations,
bandwidth and center frequency of at least one filter is
adjustable.
[0086] In some implementations, higher frequency channels of filter
bank 314 can have higher bandwidth that that of lower frequency
channels of filter bank 314. If the sampling rate for all channels
A-H were the same, for example at 16 kHz, the lower frequency
channels would need higher order filters (e.g., more taps in an FIR
filter), which increases both power consumption and occupied area
of the filters. To avoid this, multi-rate signal processing can be
used, where the lower frequency channels operate at low sample
rates, while higher frequency channels operate at higher sample
rates. This can allow each filter to provide its bandwidth with
optimum filter order without excess power consumption and occupied
area. To achieve this, the sampling rates 2 kHz, 4 kHz, 8 kHz, and
16 kHz provided by 3-stage decimation filter 312 are sent to
respective low and high frequency channels.
[0087] In the example shown in FIG. 5A, channels A-H represent low
to high frequency channels, and channels A/B, C/D, E/F, and G/H
operate at a sampling rate of 2 kHz, 4 kHz, 8 kHz, and 16 kHz,
respectively. In this embodiment, the decimation filter 312 uses
19-tap half-band FIR filters to perform anti-aliasing.
[0088] Generally, filters of filter bank 314 can be implemented
with FIR filters or Infinite Impulse Response (IIR) filters, which
can be more hardware efficient. FIR filters can operate with linear
phase, in other words constant group delay, which can have a
positive effect on sound quality and speech intelligibility. In
addition, FIR filters can have unconditional stability and regular
structure, which allows for easy design. Referring to FIG. 5A, when
sound processor circuit 206 is configured to operate in an
8-channel mode, all channels A-H are active. When sound processor
circuit 206 is configured to operate as a 6-channel mode, channels
D and H are clock-gated and turned off, and channels A-C and E-G
map as channels 1 to 6, respectively. When sound processor circuit
206 is configured to operate in a 4-channel mode, channels B, D, F,
and H are clock-gated and turned off, and channels A, C, E, and G
are mapped to channels 1 to 4, respectively. Filters of the filter
bank 314 can be reconfigured depending on the channel mode so that
the cut-off frequencies of the individual filters can be adjusted
depending on the channel mode.
[0089] Regardless of the channel mode, sound processor circuit 206
can cover a bandwidth from 300 Hz to 5.5 kHz. The reconfigurability
of the filter bank 314 are achieved by implementing three types of
FIR filters with different levels of reconfigurability as described
in relation to FIG. 5B. FIG. 5B is a schematic showing three
different types of FIR filters used in filter bank 314.
Coefficients (also referred as "coefficient signals") labeled as
reference number 560 can be chosen from three values, coefficients
labeled as reference number 562 can be chosen from two values, and
coefficients labeled as reference number 564 have one fixed value.
The number of taps in each filter increases with the number of
channels for more selectivity. x[n] is the input of signal received
from ADC 305, and y[n] is the filtered output sent to extractor
316. Coefficient signals are also input to the filters for
multiplication to x[n].
[0090] Filter 550 is the most reconfigurable filter (also referred
as FIR X3) among the three types. Filter 550 can be programmed to
three different filter lengths: 14-, 16-, or 20-taps used in the
4-, 6-, or 8-channel mode, respectively. Filter 550 is used for
channels A, C, E, and G in all 4-, 6-, or 8-channel mode. Filter
552 is also referred as FIR X2 filter, which is used for channels B
and F, and can be programmed to two different filter lengths: 16-
or 20-taps used in the 6- or 8-channel modes, respectively. Filter
552 is clock-gated when the sound processor circuit 206 operates in
the 4-channel mode. Filter 554 is a 20-tap FIR filter used for
channels D and H, and is fixed and used in the 8-channel mode.
Filter 554 is clock-gated during operation in 4- or 6-channel
modes. In some implementations, clock-gating is applied to channels
that are not selected and turned off. This approach reduces the
number of channels and saves power consumption of the cochlear
implant.
[0091] Digital circuits such as the filters can draw power when the
filters receive rising edges of input clock signals. Therefore,
filters of channels that are not being used can still consume power
if such filters receive the clock signals. To reduce power
consumption, the filters that are not being used can be
clock-gated. For example, clock-gating a filter can be achieved by
sending a clock signal and a logic turn/off signal into an AND
gate, and then sending the output of the AND gate to the filter.
When the filter is not being used, a logic off signal is sent to
the AND gate so that its output is zero (off). The filter receives
a zero signal and does not draw power. On the other hand, when the
filter is to be used, a logic on signal is sent to the AND gate so
that its output is the clock signal, which is received by the
filter for operation.
[0092] Another scheme to save power is to use symmetric
coefficients for filters 550-554. When using symmetric
coefficients, the filters can be folded so that a pair of filters
can use the same multiplication (indicated by ".times." with outer
circle in FIG. 5B). Hence, the number of multiplications of
coefficients and input x[n] can be reduced by half so that power
consumption is reduced.
[0093] Moreover, filter word lengths can be optimized for the given
filter coefficients. For example, the coefficients can be quantized
to 8-bit precision, which can be the minimum without significantly
affecting the frequency response. In this way, the coefficients do
not need to be higher precision (e.g., 9-bit or more) so as to save
power-multiplication using higher precision can lead to more power
consumption. The filters can be implemented in transposed form so
that there is at most one adder in their critical path.
[0094] Referring back to FIG. 5A, signals filtered by filter bank
314 are passed through extractor 316, which extracts the envelope
of the signals for each channel rectifying the signals and then
passing through a low-pass filter. An input logic signal can be
used to select whether the rectification type is a full-wave or
half-wave rectification. The low-pass filter can have a cut-off
between 50 Hz to 500 Hz. For example, the low-pass filter can be a
2.sup.nd-order Butterworth filter with a 400 Hz cut-off used to
limit the bandwidth of extracted envelopes before being
down-sampled as an output with data rate of 1 kHz by passing
through down-sampler 502. The output of each channel can be a 6-bit
value.
[0095] The extracted envelope and down sampled signals provided by
the extractor 316 and down-sampler 502 can be passed onto
compressor 318. In FIG. 5A, the optional fitting circuit 320 is
depicted together with compressor 318 as one block component. When
signals pass through compressor 318, a channel gain applied to all
channel can be applied from 2.sup.-4 to 2.sup.3. In some
implementations, the signals can be logarithmically compressed in
amplitude according to Eq. (2):
Y = ln ( 1 + CX ) ln ( 1 + C ) ( 2 ) ##EQU00002##
where X is the input, Y is the output, and C is the compression
factor. Logarithmic compression can be applied to take account of
the loudness growth function of electrical hearing that describes
the linear relationship between acoustic sound intensity in decibel
(dB) sound pressure level (SPL) and electric stimulation intensity
in amperes. The value of C can be variable to accommodate different
amounts of compression, which may be used for different subjects.
For example, C can be 1024, 128, and 16. Generally, C can be other
values and selected to be specific to a subject. For example, the
value of C can be selected by adjusting the value while testing how
the subject perceives the sound. In some implementations,
compression functions with different C values can be stored in the
sound processor circuit 206 as look-up tables, for example, each
with 512 6-bit wide values.
[0096] For each channel, the compressed signals output from
compressor 318 can pass through a fitting circuit 320. The fitting
circuit 320 can be used during an audiology fitting session to
adjust the dynamic range between the minimum and maximum current
level for each electrode corresponding to the respective channel to
ensure a patient specific fit for individual threshold (THR) and
most-comfort able-level (MCL) settings. The THR can be a threshold
level that the patient starts to perceive sound. The MCL can be the
level that the patient perceives the level of sound as being most
comfortable for listening. Each channel can have a 3-bit
programmability for both THR and MCL. As shown in FIG. 5A, outputs
of the sound processor circuit 206 are dstimA[5:0] to dstimH[5:0]
corresponding to channels A to H, respectively. Each output is
updated at a rate of 1 kHz and sent to waveform stimulator 208,
which can be used to modulate a train of current pulses, for
example, at 1000 pulse/s per electrode).
[0097] Each output from the channels of sound processor circuit 206
is the compressed temporal envelope of signals at the particular
frequency band of the respective channel. The envelope can be used
to determine the strength of the stimulus delivered to
corresponding electrodes of electrode array 210.
[0098] Waveform Stimulator and Electrode Array
[0099] Waveform stimulator 208 can include a digital waveform
interface circuit 602, current source 604, and electrode switch
matrix 606 as schematically shown in FIG. 6. Implementing the CIS
strategy allows the use of a single (only one) current source 604
to provide electrical pulses to all electrodes of electrode array
220. The electrical pulses can be sequentially applied using
electrode switch matrix 606 to activate an electrode and control
the direction of current flow. A common return electrode can be
used as the return path for all electrodes. The digital waveform
interface circuit 602 can be used to provide a shape of the
waveform of the electrical pulses passing through the activated
electrodes. Parameters (e.g., shape, pulse-width) can be loaded to
the digital waveform interface circuit 602 through a serial
programming interface (SPI). The digital waveform interface circuit
602 can provide control signals for the electrode switch matrix
606.
[0100] In some implementations, a single current source 604 can
provide currents to multiple electrodes of electrode array 210
through electrode switch matrix 606 (e.g., high-voltage electrode
switch matrix). The electrode switch matrix 606 can control which
electrode is selected to apply the current supplied by current
source 604. To describe the operation of the electrode switch
matrix 606, FIGS. 7A and 7B show schematics of electrode switch
matrix 606 operating during cathode phase and anodic phase,
respectively, of pulses applied to electrodes. In these figures,
electrodes E.sub.i (i=1 to 8) represent the intracochlear
electrodes of electrode array 210, and E.sub.com is the common
return electrode. Switches S.sub.c, S.sub.A, S.sub.iC, and S.sub.iA
are used to select the active electrode (E.sub.i) and control the
direction of current flow. Electrode E.sub.i is active when its
corresponding S.sub.ic or S.sub.ia is closed. In FIGS. 7A and 7B,
electrode E.sub.4 is the active electrode.
[0101] Referring to FIG. 7A, electrode switch matrix 606 provides
the cathodic phase of a stimulation pulse through E.sub.4 when
S.sub.c and S.sub.4C is closed (i.e., turn on). Dash arrows 702
show the direction of current flow. The current flows negatively
through E.sub.4 from VIVID, which is a voltage supply (e.g., high
voltage supply of 5-10 V). The strength of the current is
determined by the current source 604. In this example, the current
source 604 is a 6 bit source (I.sub.DAC [5:0]), which is described
in detail later. Referring to FIG. 7B, electrode switch matrix 606
provides the anodic phase of stimulation pulse through E.sub.4 when
S.sub.c and S.sub.4C is open (turned off) and S.sub.A and S.sub.4A
is closed. The current direction in electrode E.sub.4 is reversed
as indicated by dash arrow 752. The electrode switch matrix 606
works as an H-bridge and current flows from V.sub.MID towards
ground of current source 604.
[0102] During each of the cathodic and anodic phases, digital
waveform interface circuit 602 controls current source 604 to
provide a controlled waveform shape of electric pulses pass through
the active electrode in electrode switch matrix 606. In between
cathodic and anodic phases of a given pulse, an optional switch
S.sub.dum (also referred as S.sub.IPG) can be used to insert an
inter-phase gap. After the completion of each pulse, switch S.sub.i
is turned on to short electrode E.sub.i, which was active, to
ensure that residual charges are depleted. In some implementations,
a DC blocking capacitor (e.g., with capacitance of 220 nF) can be
placed in series with the electrodes so that no DC current flows to
the nerve fiber for safety.
[0103] Various switches of electrode switch matrix 606 can be
controlled using several clocks. For example, several
non-overlapping clocks and control signals can be used to generate
on-off signals for switches S.sub.c, S.sub.a, S.sub.iC, S.sub.iA,
and S.sub.dum. An example is described in relation to FIG. 5-13 of
U.S. Provisional Application 61/908,237 filed on Nov. 25, 2013, the
entire contents of which are incorporated herein by reference.
[0104] Referring back to the example shown in FIG. 6, current
source 604 includes an op-amp, digital-to-analog converter (DAC),
and voltage-controlled resistor (VCR). The DAC receives data signal
from digital waveform interface circuit 602 described later. The
DAC can operate by a 3.3 V power supply and leverage current
steering to achieve fast settling for generating arbitrary
waveforms with a short time step. For example, the time step can be
2.5 .mu.s to provide a phase width of 25 .mu.s with 10 steps/phase.
Input code D[5:0] from the digital waveform interface circuit 602
can steer binary-weighted currents. The VCR can have a large output
impedance and high voltage compliance. High output impedance is
used so that the current delivered to the electrodes do not depend
on the electrode impedance. High voltage compliance is used for
high efficiency and to avoid saturation of the current source 604
when the electrode impedance and the delivered currents are high.
In some implementations, the current source 604 can provide 6 bit
resolution of current strengths supplied through electrodes. The
high resolution can lead to various shapes as well as amplitudes of
waveform of the electric pulses provided to the electrodes. In some
implementations, multiple current sources can be used to provide
the functions described in relation to current source 604.
[0105] In some implementations, current source 604 can achieve fast
settling to generate electrical pulses having waveforms with short
time steps. FIG. 7C is a schematic of an example of waveform 770 of
an electrical pulse generated by current source 604. X-axis is time
and y-axis is current. In this example, during time duration
t.sub.1, the current source 604 provides current at amplitude 772.
The current source 604 can change the current amplitude by an
amount 774 so that during time duration t.sub.2, the current source
604 provides current at the sum of amplitudes 772 and 774. Time
durations t.sub.1 and t.sub.2 can be referred as a time step of the
waveform. The time step can be 5 .mu.s or less (e.g., 4 .mu.s or
less, 3 .mu.s or less, 2.5 .mu.s or less, 2 .mu.s or less, 1 .mu.s
or less). By changing the current amplitude for different time
steps, the current source 604 can provide an arbitrary waveform. As
the time step becomes smaller, the current source 604 has more time
resolution to provide a waveform resembling a smooth and continuous
waveform. In some implementations, the current source 604 can vary
the current amplitude within short times scales (e.g., within time
duration t.sub.1). For example, the current source 604 can change
the current amplitude by 0.5 mA or more (e.g., 0.6 mA or more, 0.7
mA or more) within one time step. Such fast adjustment of current
amplitudes can be achieved by fast settling capabilities of the
current source 604.
[0106] In the example illustrated in FIG. 7C, pulse width 780
corresponds to the cathodic phase and pulse width 782 corresponds
to the anodic phase of the waveform 770. Accordingly, the cathodic
phase has 6 steps/pulse and the anodic phase has 6 steps/pulse.
Generally, the cathodic and anodic phases can have different
numbers of steps/pulse.
[0107] FIG. 7D is a schematic of an example of a current source 604
that provides fast settling as described in relation to FIG. 7C.
The current source 604 can include a DAC 786 and a
voltage-controlled resistor (VRC) 788. The DAC 786 can be a 6-bit
resolution DAC that provides voltages V.sub.G[0]-[3] to control the
VCR 788. The DAC 786 can leverage current steering to achieve fast
settling to generate arbitrary waveforms. The input data signal
D[5:0] from digital waveform interface circuit 602 can steer
binary-weighted currents to I.sub.p that is then mirrored to output
branch. A resistor string can convert current I.sub.p (dependent on
D[5:0]) into the control voltages V.sub.G[0]-[3]. In some
implementations, the DAC 786 can have cascoded transistors 787 that
have a constant current flowing through cascaded transistors 787 so
as to enable fast steering of currents between I.sub.m and I.sub.p
depending on D[5:0]. I.sub.p can be continuously flowing from
supply (e.g., 3.3V supply) during operation of the current source
604 so that fast switching of voltages V.sub.G[0]-[3] can be
achieved. This aspect can lead to the fast settling feature of the
current source 604.
[0108] The current source 604 can be operated from a 3.3V supply.
The current source 604 can use a feedback to force a reference
voltage V.sub.DSREF across VCR 788 with value R.sub.VCR. The output
current can be expressed as Eq. (3):
I DAC = V DS R VCR = V DSREF R VCR ( 3 ) ##EQU00003##
where V.sub.DS=V.sub.DSREF through a virtual short as long as the
loop gain is high. R.sub.VCR of VCR 788 can be varied to adjust
I.sub.DAC, which corresponds to the current amplitude described in
relation to FIG. 7C. The VCR 788 can include a bank of n-channel
metal-oxide-semiconductor (NMOS) transistors that collectively
provide a linear resistance. In this example, R.sub.VCR is a
function of gate voltages V.sub.G[0]-[3] provided by DAC 786.
M.sub.o can be the main triode device that carries the majority of
I.sub.DAC being controlled by V.sub.G[0]. M.sub.1 to M.sub.3 can be
auxiliary devices controlled by V.sub.G[1]-[3]. V.sub.DSREF can be
set to 100 mV so that M.sub.o is a triode device and to limit the
headroom of the current source 604 to achieve high compliance.
[0109] As mentioned earlier, digital waveform interface circuit 602
can be configured to provide a shape of the waveform of the
electrical pulses provided by current source 604. FIG. 6 shows a
schematic of an example of the digital waveform interface circuit
602. The digital waveform interface circuit 602 includes an
electrode select state machine, channel select circuit, waveform
select circuit, and step counter. The electrode select state
machine receives clock f.sub.LO and f.sub.HI, and generates signals
for switches of S1 to S8 of electrode switch matrix 606 and passes
onto channel select circuit. The electrode select state machine can
receive control signals used to reconfigure the state machine
between 4-, 6-, and 8-channel modes.
[0110] The channel select circuit can receive the data signal
dstimA[5:0] to dstimH[5:0](also labeled as chA[5:0] to chH[5:0])
from sound processor circuit 206. The channel select circuit can
choose the data signal of the corresponding electrode that is
activated by the electrode state select machine, and use the chosen
data signal to determine the strength of electric pulses to be
applied by current source 604 for the activated electrode. On the
other hand, the waveform select circuit can receive input
parameters w00[3:0] to w15[3:0] of the waveform to be generated
from an SPI. The waveform select circuit provides the waveform
shape to current source 604. Parameters w00[3:0] to w15[3:0] can be
multiplied to chA[5:0] to chH[5:0] to generate output D[5:0], which
is the input to current source 604.
[0111] In this way, output (dstimA[5:0] to dstimH[5:0]) of sound
processor circuit 206 can modulate the amplitude of stimulus
pulses, while the shape of the pulses are determined by height of
the pulse, which has an arbitrary waveform shape determined input
parameters w00[3:0] to w15[3:0] from SPI. In the example shown in
FIG. 6, w00 to w03 specify the shape of the cathodic phase, and w04
to w07 specify the shape of the anodic phase. The multiplication of
a set of parameters w00 to w15 can be carried out for each channel
sequentially. Step counter counts the number of steps per pulse.
The total number of steps can be 8 steps/pulse (e.g., 16
steps/pulse).
[0112] In some implementations, the total number of steps can be
adjusted. Frequency of f.sub.HI and f.sub.W can be tuned to vary
the phase width and number of step/phase, respectively, of the
waveform to be generated.
[0113] In some implementations, the digital waveform interface 602
can control the waveform so that the charge delivered to the nerve
fiber during the cathodic phase within 5% or less (e.g., 3% or
less, 1% or less) of the charge delivered during the anodic phase.
The waveform stimulator 208 can utilize DC blocking capacitors and
a shorting phase so that no or negligible DC current is delivered
to the nerve fiber for safety.
[0114] In some implementations, the digital waveform interface
circuit 602 can operate at 0.6 V to save power consumption.
Accordingly, a two-stage level shifter can be used between the
low-voltage (e.g., 0.6 V) digital domain and the high-voltage
(e.g., 7V to 12V) domain of the electrode switch matrix 606. The
two-stage level shifter can be used so that the low-voltage domain
and the high voltage domain are compatible with each other. For
example, an intermediate voltage of 1.8 V can be used in the
two-stage level shifter between the 0.6 V power supply and high
(e.g., 7 V to 12V) voltage power supply. An example is described in
relation to FIG. 5-15 of U.S. Provisional Application 61/908,237
filed on Nov. 25, 2013, the entire contents of which are
incorporated herein by reference.
[0115] Power supplies providing power at 1.0 V or less can be used
in cochlear implant 200 to power various components and to provide
the required nerve stimulation. In some implementations, the power
supply can provide power at less than 0.6 V. For example, a lower
power (e.g., 0.6 V) supply can be used so as to operate the
component close to the component's minimum energy point of energy
dissipation within 10% (e.g., within 5% or within 3%) to maximize
energy efficiency of the component's operation. Scaling the power
supply voltage of digital circuits down to moderate inversion
slightly above their threshold can provide a good balance between
digital energy efficiency and performance bandwidth. On the other
hand, power consumption of analog circuits can be a complex
function of factors such as dynamic range, gain-bandwidth,
topology, and supply voltage. Digital processing at 0.6 V can be
used to leverage the benefits of voltage scaling of digital
circuits.
[0116] Flow chart 1700 in FIG. 17 depicts examples of operations
for designing a circuit that operates from a power supply providing
1 V or less (e.g., 0.6 V). Operations can include writing
register-transfer level (RTL) code description of a circuit (1710).
Operations can also include verifying functionality through
simulation of the circuit (1720). Design synthesis can be performed
through logic optimization, map to technology, and adding timing
and area constraints of components of the circuit (1730). Operation
1730 can be performed at a nominal voltage technology (e.g. 1.8V
for a 180 nm complementary metal-oxide-semiconductor technology)
with the nominal technology library and add significant timing
margins so that the circuit can operate at a low voltage such as
0.6V. In another approach, operation 1730 can be performed by
re-characterizing the technology library at 0.6 V and running the
design synthesis with the re-characterized technology library.
Operations can further include performing design implementation:
floor planning and checking function, timing, place and route, and
physical layout. These operations can be used to design power
supply voltage, clock frequency, and threshold voltage of the
circuit so as to operate at its minimum energy point
dissipation.
[0117] Generally, cochlear implant 200 can be powered by a battery
212 (e.g., rechargeable battery). In some implementations, a
wireless power delivery scheme can be used to charge an
ultra-capacitor or battery that supplies power for operation of
various components of cochlear implant 200. Utilizing a wireless
power delivery and storage scheme can enable untethered usage for a
full day, and eliminate the need for an external power unit. The
battery 212 can be recharged when a subject is in a specific
location for a length of time, e.g., asleep, at a desk, while
watching television, or is otherwise at rest.
[0118] Reconfigurability and programmable capability of cochlear
implant 200 are designed to provide scalability of stimulation
power, which can lead to power saving schemes. For example, in some
implementations, power consumption of sound processor circuit 206,
current source 604, and stimulation power can scale linearly with
the number of operating channels. This can be achieved by
clock-gating digital circuits and power-gating analog circuits
(e.g., current source) when not in use. Clock-gating was previously
described in relation to reconfigurable filters. Power-gating of an
analog circuit can be achieved, for example, by using a transistor
between power supplies that supply power to the analog circuit. The
transistor can receive an on/off signal that controls whether power
is supplied to the analog circuit. For example, when an "on" signal
is input to the transistor, power can be applied from the power
supply to the analog circuit. By controlling the transistor so that
the analog circuit does not receive power when the analog circuit
is not in use power consumption can be reduced. In some
implementations, digital circuits and analog circuits can
send/receive handshake signals to each other to control the
respective clock-gating and power-gating during operation of the
overall circuits.
[0119] General Methodology
[0120] The techniques disclosed in this specification provide
methods for generating energy-efficient stimulation waveforms for
significantly reducing the stimulation power needed to operate a
cochlear implant 200. In some implementations, the cochlear implant
200 can provide biphasic electrical neural stimulation waveforms
that are more energy-efficient than conventional waveforms (e.g.,
rectangular waveforms). The energy-efficient waveforms can be
generated by SPI and digital waveform interface circuit 602 as
described herein.
[0121] FIG. 8 is a schematic of a conventional waveform 800 applied
to an electrode for stimulation. Waveform 800 includes a cathodic
(excitory) phase 802, which is depolarizes a nerve fiber, followed
by an anodic (recovery) phase 804, which is applied so that no net
charge is delivered to the nerve fiber. The cathodic phase 802
precedes the anodic phase 804. In FIG. 8, both cathodic and anodic
phases 802 and 804 have same phase width 806 and same current
amplitude 812. The two phases 802 and 804 are separated by an
inter-phase gap 808 so that the total pulse width 810 is the sum of
two phase width 806 and the inter-phase gap 808. During the
cathodic phase 802, the chip delivers charge from the electrode to
the nerve fiber in one direction, and during the anodic phase 804,
charge is delivered in the reverse direction.
[0122] The waveform 800 can also be referred as a "biphasic
rectangular current pulse," because of the rectangular shapes of
the cathodic and anodic phases 802 and 804. Such a waveform has
been used for its simple shape and ease of generation, and was
assumed to be optimum for charge-balancing and minimizing the
energy consumed under the constraint of delivering equal charge.
However, the threshold for neural activation is a function of
waveform shape, and activation of a neural fiber can be achieved
with different amounts of charge injection depending on the
waveform shape. Accordingly, the techniques disclosed herein
provide methods for determining and generating alternate waveforms
differing from conventional waveform 800 to achieve the same level
of neural activation while reducing the amount of energy consumed
in generating the alternate waveforms.
[0123] A cochlear implant 200 can include an electronic processor
that calculates and determines a waveform to be used for providing
stimulus pulses by the cochlear implant 200 to a neural fiber. In
some implementations, the electronic processor is external and not
included in the cochlear implant 200, and can send the determined
waveform parameters to the cochlear implant 200. For example, the
electronic processor can be included in a computer system of a
clinical lab. The electronic processor can be configured to send
the determined waveform parameters to the cochlear implant 200 via
an SPI as described earlier.
[0124] The electronic processor can calculate a waveform once and
the parameters of the waveform can be saved in the cochlear implant
200. For example, the parameters can be saved in waveform
stimulator 208. The parameters can be saved in a memory of the
cochlear implant 200. In this way, the waveform does not need to be
calculated every time the waveform stimulator 208 generates
electrical stimulus pulses based on the waveform but rather use the
same waveform over repeated generation of pulses. In some cases,
the electronic processor can recalculate a new waveform that is
saved in the cochlear implant 200. The recalculation can be
periodically done without user input or can be prompted by a person
(e.g., the subject or clinician). In some implementations, the SPI
described in preceding sections can calculate and determine the
waveform in a similar manner described in relation to the
electronic processor.
[0125] In some implementations, the electronic processor can
calculate the energy of a waveform as defined as the energy per
unit resistance ( .sub.elec) in the electrode of the phase width
(PW) according to Eq. (4):
E _ elec = E elec R elec = < PW > I 2 ( t ) dt ( 4 )
##EQU00004##
where I(t) is the current of the waveform, PW is pulse width,
E.sub.elec is the total waveform energy, and R.sub.elec is the
electrode resistance, assuming there is no energy wasted by
headroom of current source 604.
[0126] In some implementations, the electronic processor can select
a computational model of a nerve fiber (e.g., mammalian myelinated
nerver fiber) to calculate the energy of various waveforms. For
example, the Hodgkin-Huxley type discrete cable model can be used
as the computational model of a single nerve fiber. FIGS. 9A-C are
schematics of a computational model 900 used for calculating a
trigger of action potential for various stimulus waveforms. Model
900 can include "n" current sources (I.sub.1 to I.sub.n),
electrodes, and target neural tissue (also referred to as a neural
fiber). FIG. 9A depicts path stimulation current i(t) from the ith
current source I.sub.i (i=1 to n) through an optional DC blocking
capacitor CBI (e.g., 100-900 nF) to the intercochlear electrodes
Z.sub.Ei. FIG. 9B shows a model of the impedance of electrodes
Z.sub.Ei. In this model C.sub.d represents the double-layer
capacitance at the electrode-fluid interface at the cochlear, and
R.sub.s is the fluid resistance. Values of 5-50 nF and 2-10 kW can
be used for C.sub.d and R.sub.s, respectively, to calculate power
dissipated in each electrode Z.sub.Ei.
[0127] From the intracochlear electrodes Z.sub.Ei, current spreads
through the tissue, cartilage, and bone. Assuming the tissue to be
homogeneous and isotropic with a resistivity of r.sub.e (e.g.,
about 300 W.times.cm), voltage V.sub.e(t) generated in the tissue
by stimulation current i(t) at a distance "r" from electrode
Z.sub.Ei can be calculated according to Eq. (5):
V e ( t ) = r e i ( t ) 4 pr . ( 5 ) ##EQU00005##
The calculated V.sub.e(t) can be applied to a nerve fiber model
(e.g., Hodgkin-Huxley type discrete cable model) as a extracellular
potential to determine whether an action potential is triggered.
The calculations can be repeated for various waveforms to determine
which waveform with less energy can trigger the action potential.
FIG. 9A shows i(t) with a biphasic rectangular pulse as an example,
however, the electronic processor can carry out the calculation of
an arbitrary shape of i(t), and compare the energy for different
shapes. From the tissue, current i(t) is collected by a common
extracochlear return electrode Z.sub.RET, which impedance is
typically smaller than that of electrodes Z.sub.ei.
[0128] Electronic processor can generate and optimize the waveforms
in several approaches. For example, the electronic processor can
utilized a heuristic algorithm such as a genetic algorithm (GA) to
determine a highly energy efficient waveform shape. Other
algorithms such as a simulated annealing algorithm can also be
utilized. The electronic processor implementing a genetic algorithm
can be configured to:
[0129] (a) for a first generation of population, randomly generate
multiple waveforms spanning the space of possible solutions;
[0130] (b) calculate a fitness quotient (e.g., energy of the
waveform) for each waveform of the population;
[0131] (c) select waveforms with low energies as parent solutions
that are used to generate waveforms in the second generation;
[0132] (d) generate a second generation of population, where two
parent solutions are selected and their characteristics are blended
and mutated together; and
[0133] (e) repeating steps (b)-(d) for a larger number of
generations until one or more waveforms with energies lower than a
predetermined threshold is met. Parameters of such one or more
waveforms can be sent to digital waveform interface 602.
[0134] In some implementations, a genetic algorithm can begin with
an initial population of 50 waveforms, each discretized to 20 time
steps (also referred as "genes"). Duty of the waveform can be
constrained such that the cathodic and anodic phases have same
phase widths. For example, each phase can include 10 time steps,
which can provide sufficient degrees of freedom to simulate an
arbitrary waveform shape. In some implementations, the duty cycle
of the cathodic and anodic phase can differ so that each phase has
a different number of time steps. For example, the ratio of the
pulse width of the cathodic and anodic phases can be 40:60 or less
(e.g., 30:70 or less). An example is described in relation to FIG.
3-9 in U.S. Provisional Application 61/908,237 filed on Nov. 25,
2013, the entire contents of which are incorporated herein by
reference. As described herein, both cathodic and anodic phase need
not be constrained to be rectangular in shape so that efficiency
enhancement of both the cathodic and anodic phase is carried out.
The fitness quotient can be calculated as the energy of the
waveform plus an energy penalty if no action potential is triggered
to filter out the unfit waveforms. The genetic algorithm can be
carried out for a large number of generations of 5000 or more
(e.g., 7500 or more, 10000 or more, 12500 or more, or 15000 or
more).
[0135] An electronic processor can be configured to produce an
evolution of a waveform over generations of 1, 10, 100, 1000, 10000
or more. Total pulse duration of the waveform can be 100 .mu.s or
less (e.g., 50 .mu.s or less). When the duty cycle between the
cathodic phase and the anodic phase of the waveform is 50:50 with
no inter-phase gap, phase width of two phases can each be 50 .mu.s
or less, 25 .mu.s or less). FIGS. 10A-C show plots 1010, 1020, and
1030 showing an evolution of an example waveform and its energy for
a total pulse duration of 50 .mu.s, where the cathodic phase and
anodic phase each 20 .mu.s phase width. For plots 1010 and 1020,
x-axes show the time of the waveform and y-axes show current
amplitude. The cathodic phase starts from 10 .mu.s to 35 .mu.s, and
the anodic phase starts from 35 .mu.s to 60 .mu.s. FIG. 10A shows
the waveform after 10 generations, and FIG. 10B shows the waveform
after 10000 generations. Solid line 1032 of FIG. 10C shows the
energy evolution of the waveform over the number of generations,
and dashed line 1034 shows energy of biphasic rectangular waveform
having both rectangular cathodic and anodic phases as shown in FIG.
8 with no inter-phase gap. Dashed line 1034 has an energy of about
3.8 pJ/W and solid line 1032 has an energy of about 2.8 pJ/W for
triggering an activation potential, respectively.
[0136] Accordingly, the evolved waveform (represented by solid line
1032) can be about 28% more energy-efficient after about 10000
generations than the biphasic rectangular waveform (represented by
dash line 1034). In some implementations, the evolved waveforms can
be 35% or more (e.g., 54% or more) energy-efficient. The cathode
phase of the evolved waveform can resemble (but not exactly be) a
decreasing exponential cathodic phase, and the anodic phase can
resemble a rectangular shape but differs from an exact rectangular
shape. In some implementations, the electronic processor can
produce waveforms with different total pulse duration and/or
different duty cycle between the cathodic phase and the anodic
phase.
[0137] Flow chart 1100 in FIG. 11 depicts examples of operations
for stimulating auditory nerves of a subject using cochlear implant
200. Operations can include detecting a vibration signal using an
acoustic sensor 202 such as a piezoelectric sensor (1110). The
vibration can be the vibration of the umbo due to sounds input to
an ear of the subject. In some implementations, the acoustic sensor
202 can contact the middle ear within 2 mm or less (e.g., 1 mm or
less) of the center of the umbo.
[0138] Operations can also include generating electric signals by
processing the detected vibration signals using a sensor front-end
circuit 204 (1120). In some embodiments, the sensor front-end
circuit 204 can be electrically impedance matched to acoustic
sensor 202 to efficiently collect current from the acoustic sensor
202. The sensor front-end circuit 204 can amplify the signal and
convert the amplified signal into a digital signal using an ADC
305.
[0139] Sound processor circuit 206 spectrally decomposes the
converted electric signals to generate decomposed information for
multiple channels of the sound processor circuit 206 (1130).
Different channels represent different frequencies of sound. The
spectral decomposition can be achieved by passing through the
converted signal to a 3-stage decimation filter 312 and filter bank
314. The decomposed signal is passed onto an extractor 316 for
extracting an envelope for each channel. The envelope extracted by
extractor 316 can be processed through compressor 318 and fitting
circuit 320 as described in relation to sound processor circuit 206
in the preceding paragraphs.
[0140] Operations can also include determining a waveform using a
heuristic algorithm such as a genetic algorithm, using, for
example, an electronic processor (1140). The electronic processor
can generate waveforms over an evolution over multiple generations
(e.g., 10000). The electronic processor can calculate energy of the
waveforms over the multiple generations. The electronic processor
can stop the evolution after a fixed number of generations or after
the energy reaches a predetermined threshold. In some
implementations, the electronic processor can be configured to fix
or adjust the total pulse width, duty cycle, number of steps/phase,
inter-phase gap, for example, depending on the used computational
model. The determined waveform can have both its cathodic phase and
anodic phase differ from a rectangular shaped waveform. This
operation can be done once and parameters of the determined
waveform can be used repeatedly to generate electrical stimulus
pulses over an extended period of time by cochlear implant 200. In
some cases, the electronic processor can be prompted to recalculate
a new waveform to take into account any changes of the subject or
environmental conditions.
[0141] A current pulse can be generated based on the determined
waveform in operation 1140 (1150) by sending parameters of the
determined waveform to a waveform stimulator 208, which can
generate a current pulse shaped according to the determined
waveform. The waveform stimulator 208 can include a digital
waveform interface circuit 602, a current source 604, and an
electrode switch matrix 606 that are used in combination to
generate the current pulse and apply the current pulse to electrode
array 210.
[0142] Operations can also apply the current pulse to stimulate an
auditory nerve by passing through multiple electrodes of the
electrode array 210 (1160). The magnitude of the current pulse for
each electrode can be controlled by the waveform stimulator 208
based on the decomposed information in operation 1130. Each
electrode can correspond to a particular frequency band of sound to
be perceived by a subject. When a large magnitude of current pulse
is applied to a specific electrode, the subject may perceive a
large sound for the frequency band represented by the specific
electrode.
[0143] In some implementations, determination of the waveform in
operation 1140 can be implemented before cochlear implant 200 is
implanted into the subject. For example, a high efficiency waveform
can be determined and loaded and saved on waveform stimulator 208.
This approach can be taken when there is little or no need to
change the shape of current pulses generated by the waveform
stimulator 208 over an extended period of the use of the cochlear
implant 200. In some implementations, operation 1140 can be
implemented after the cochlear implant 200 is implanted to the
subject. For example, the waveform stimulator 208 can include an
electronic processor and memory that executes a code to determine a
high efficiency waveform based on the disclosed techniques in this
specification. The high efficiency waveform can be fitted to a
specific patient by the electronic processor calculating a genetic
algorithm and receiving input from the subject on whether the
subject perceives sound for various waveforms generated by the
algorithm.
[0144] Examples of operations depicted in FIG. 11 need not be
carried out in the order shown in FIG. 11. In some implementations,
some operations shown in FIG. 11 can be omitted. For example,
operation 1140 can be omitted when the waveform is
predetermined.
[0145] In some cases, the high efficiency waveform can be
re-accessed over time while the cochlear implant 200 is implanted
to reflect any condition changes of the subject. Electronic
processor, which may be included in cochlear implant 200 or
external to cochlear implant 200 can function as a calibration
circuit configured to measure hearing thresholds (e.g., by
receiving input from the subject) for various of waveform shapes
and select a waveform shape having a low energy of 3.5 pJ/W or less
(e.g., 3.2 pJ/W or less, 2.8 pJ/W or less). The electronic
processor need not calculate a high efficiency waveform every time
the cochlear implant 200 generates a pulse. Therefore, in some
implementations, the electronic processor can be external, and for
example, send any recalculated waveform parameters wirelessly using
WiFi, Bluetooth, or near field communication (NFC) to the cochlear
implant 200 when needed.
[0146] During use of cochlear implant 200, the number of channels
for sound processing can be adjusted. For example, the channel mode
can be changed between 4-, 6-, and 8-channel modes. In some
implementations, the number of channels can be 12 or more (e.g., 16
or more, 22 or more), and the channels be reconfigured. Such
reconfigurability can be used to reduce power consumption depending
on a subject's needs and the battery capacity of the cochlear
implant 200. For example, some subjects may only need 6 channels to
have good sound perception. In this case, the cochlear implant 200
can operate in 6-channel mode instead of 8-channel mode to reduce
power consumption. In other examples, cochlear implant 200 can be
operating in 8-channel mode when battery 212 is fully charged, but
can be changed, either automatically or manually, to operate in
4-channel mode when the battery 212 becomes nearly depleted to save
power consumption. For example, the cochlear implant 200 can
include a battery level sensor that measures the charge level of
the battery 212. When the charge level is below a predetermined
threshold (e.g., 20% or less) of the full capacity, the battery
level sensor can send a control signal (e.g., via sel_chan) to
sound processor circuit 206 to change the channel mode to a lower
number of channels to reduce power consumption. In another example,
the battery level sensor can send a signal to an external device
(e.g., mobile smartphone). The subject can monitor the batter level
through the external device, and send a control signal (e.g., via
the external device) to sound processor circuit 206 to change the
channel mode to a lower number of channels to reduce power
consumption.
[0147] Performance of Device
[0148] Various components of cochlear implant 200 can be
manufactured on a single chip using, e.g., a 0.18 .mu.m
high-voltage complementary metal-oxide-semiconductor (CMOS)
technology. For example, sensor front-end circuit 204, sound
processor circuit 206, waveform stimulator 208, electronic
processor, and battery 212 of the cochlear implant 200 can be
manufactured on a single chip. In some implementations, acoustic
sensor 202 can be attached to the middle ear ossicle, such as the
incus, stapes, or malleus, e.g., with the umbo of the malleus and
electrode array can be attached to the nerve fiber.
[0149] The overall power consumption of cochlear implant 200 can be
less than 600 .mu.W during operation for normal conversation. For
example, the cochlear implant 200 can consume 600 .mu.W or less for
detecting an input sound of 70 dB SPL and stimulating a subject
with totally impaired cochlear function to perceive the detected
sound as 70 dB SPL, which is at about the same level as a subject
with normal hearing. This can enable 21 hours of operation from a
single 5 g ultra-capacitor with an energy density of 5 W hr/kg with
50% power conversion efficiency.
[0150] In one embodiment, sensor front-end circuit 204 can consume
6.83 .mu.A and a power of 10.3 .mu.W or less from a 1.5 V power
supply. This is about two orders of magnitude smaller than the case
using op-amps consuming 660 .mu.W from a 3.3 V power supply. The
sensor front-end circuit 204 can accommodate a range of sensor
sizes and masses.
[0151] Sound processor circuit 206 can consume 1.6 .mu.W or less
from a 0.6 V power supply when operating in the 8-channel mode. In
some implementations, the power consumption can be scaled linearly
within 15% or less (e.g., 10% or less, 5% or less) according to the
number of channels in operation. For example, in 4-channel mode,
the power consumed can be 0.8 .mu.W. In some implementations, ADC
305 and sound processor circuit 206 can together consume 1.9, 1.57,
or 1.43 .mu.W or less of power from a 0.6 V supply in 8/6/4-channel
modes, respectively.
[0152] Waveform stimulator 208 can provide energy-efficient
stimulation pulses to reduce stimulation power. For example, the
stimulation power for triggering the activation potential of a
nerve fiber can be reduce by 23% at a phase width of 31.25 .mu.s
when compared to a biphasic rectangular waveform. In some
implementations, waveform stimulator 208 can consume 560, 413, or
269 .mu.W in the 8-, 6-, and 4-channel modes.
[0153] Various examples and methods are disclosed at, for example,
portions titled Chapters 3-5 in U.S. Provisional Application
61/908,237 filed on Nov. 25, 2013, the entire contents of which are
incorporated herein by reference.
[0154] General Applications
[0155] The disclosed techniques can be used to implement fully
implantable cochlear implants for assisting hearing in subjects
with conductive hearing loss or sensorineural hearing loss. As the
disclosed cochlear implants can be very small and manufactured on a
single chip, the implants can be fully implantable and contained
inside the ear so that subjects can use the cochlear implants in
the shower and during water sports. The low-power design of the
cochlear implants allows the subjects to use the implants over an
extended period of time, thereby providing convenience of use.
[0156] Other Uses
[0157] The disclosed techniques can be applied in applications
other than stimulating auditory nerves. For example, the techniques
can be applied to other neural prostheses like retinal or
vestibular implants, or therapeutic devices such as deep brain
stimulators, or other devices that deliver electrical stimulation
of a neural tissue. Neural prostheses and implantable therapeutic
devices such as deep brain stimulators or vagal nerve stimulators
can be used for treatment of Parkinson's disease, essential tremor,
and epilepsy. Because such devices rely on delivering electrical
current pulses into nerve tissues to elicit neural responses, the
techniques disclosed herein can be used to provide devices with
low-power consumption and generating energy-efficient stimulus
waveforms.
[0158] For example, in some implementations, a nerve stimulator
device can include various components such as a digital waveform
interface circuit 602, a current source 604, and an electrode
switch matrix 606 of waveform simulator 208 described herein. The
nerve stimulator device can be used in applications described in
the preceding paragraph. Moreover, the techniques described in
preceding sections for determining an energy-efficient waveform,
for example, using a heuristic algorithm, can be used to generate
electrical stimulation pulses. In some cases, only one electrode
can be used to stimulate a neural tissue without utilizing an
electrode select state machine. In some cases, multiple electrodes
can be used to apply stimulation pulses to different tissues. The
stimulator device can include an electrode select state machine
that receives control signals for selecting which electrodes to
apply stimulation pulses.
EXAMPLES
[0159] The methods and systems described herein are further
illustrated using the following examples, which do not limit the
scope of the claims.
Example 1--Fully-Implantable Cochlear Implant
[0160] FIG. 12 shows an image 1200 of a manufactured
fully-implantable cochlear implant chip. The chip has a size of 3.6
mm.times.3.6 mm while the active die area is 3.3 mm.sup.2. The chip
was fabricated by 0.18 .mu.m high-voltage CMOS technology and
packaged in a 128-lead think quad flat package (QFP) package. The
chip includes a sensor front-end circuit 1210, sound processor
circuit 1230, waveform stimulator 1240, and SPI 1250. In this chip,
ADC 1220 is located adjacent to sensor front-end circuit 1210. The
sensor front-end circuit 1210 operated with a supply voltage of 1.5
V and the sound processor circuit 1230 operated with a supply
voltage of 0.6 V. The ADC 1220 operated at a supply voltage of 0.6
V. The chip were reconfigurable to operate in 4-, 6-, 8-channel
modes. Example specifications and power consumption of the chip are
described in relation to Table 5-4 in U.S. Provisional Application
61/908,237 filed on Nov. 25, 2013, the entire contents of which are
incorporated herein by reference.
Example 2--Sound Processor Circuit
[0161] The sound processor circuit 1230 shown in FIG. 12 was tested
using an arbitrary function generator (AFG3102 from Tektronix) to
generate arbitrary test signals at the input of the ADC 1220.
Outputs (dstimA[5:0] through dstimH[5:0]) of the sound processor
circuit 1230 were recorded and reconstructed using a computer. All
measurements with the ADC 1220 and sound processor circuit 1230
were made at a digital supply voltage of 0.6 V.
[0162] FIGS. 13A-D are images showing a demonstration the ability
of the new systems to reconfigure the number of channels of the
sound processor circuit 1230. A logarithmic chirp signal was input
to the ADC 1220. FIG. 13A is a plot 1310 showing the measured
spectrogram at the output of the ADC 1220. FIG. 13B is a plot 1320
showing the measured spectrogram of the sound processor circuit
1230 configured in a 4-channel mode. FIG. 13C is a plot 1330
showing the measured spectrogram of the sound processor circuit
1230 configured in a 6-channel mode. FIG. 13D is a plot 1340
showing the measured spectrogram of the sound processor circuit
1230 configured in an 8-channel mode. Because the sound processor
circuit 1230 used a logarithmically spaced filter bank, the
measured spectrograms were linear. The measured results show that
the sound processor circuit 1230 provides spectrograms resembling
the input chirp signal. Simulation results (not shown) show good
agreement with the measured results.
[0163] The sound processor circuit 1230 had good patient-fitting
capabilities for controlling the adjustable threshold (THR) and the
most-comfortable-level (MCL), which can be set individually for
each channel.
Example 3--Waveform Stimulator
[0164] An electronic processor and waveform stimulator were used to
generate a variety of waveforms by implementing a genetic
algorithm. Several examples are described in this section.
[0165] Waveforms were generated over various phase widths. FIGS.
14A-C are plots of energy efficient waveforms for various pulse
width. FIG. 14A is a plot 1410 showing the energy efficient
waveform for pulse width of 25 .mu.s. FIG. 14B is a plot 1420
showing the energy efficient waveform for pulse width of 50 .mu.s.
FIG. 14C is a plot 1430 showing the energy efficient waveform for
pulse width of 100 .mu.s. Each waveform in plots 1410-1430 are
obtained with 10 steps/phase after 10,000 generations through a
genetic algorithm. Phase widths can be generated, but not limited
to, from 10 .mu.s to 200 .mu.s. The generated high efficiency
waveforms are labeled as 1404 in all three plots. For comparison, a
biphasic rectangular waveform at threshold for each of the
corresponding phase widths are drawn and labeled as 1402. The
waveforms 1404 in plots 1410, 1420, and 1430 have an energy of 2.71
pJ/W, 1.84 pJ/W, and 1.49 pJ/W, respectively, for threshold of
triggering activation of nerves. Corresponding energy savings
relative to waveform 1402 were 28%, 35%, and 54%, respectively. For
plot 1410, the current of the cathodic phase is nonzero over the
entire cathodic phase. In contrast, for plots 1420 and 1430, the
genetic algorithm determined that it was not beneficial to deliver
charge at the start or the end of the cathodic phase, effectively
concentrating most of the current over a 30-40 .mu.s window in the
middle of the cathodic phase. Accordingly, energy savings may
increase for longer pulse widths.
[0166] Waveforms with uneven splits of duty cycles were generated.
For example, the duration of the cathodic and anodic phases were
allowed to be arbitrary and independent from one another. The total
durations were fixed. The results showed that the anodic phased
started earlier and the resulting duty cycle was 40:60 for the
cathodic and anodic phases.
[0167] The number of "genes" (time steps/phase) of the genetic
algorithm were adjusted. For example, the waveforms were calculated
for pulse width of 50 .mu.s with 5, 10, and 20 steps/phase. The
results showed that the waveform had a trend of decreasing
front-loaded cathodic phase followed by a relatively flat anodic
phase. However, the cathodic phase was not an exact exponential
curve and the anodic phase was not an exact rectangular shape.
[0168] FIGS. 15A-G are representations of various waveforms
generated by an electronic processor and their energies. FIG. 15A
is a plot 1510 showing a biphasic waveform with a decreasing
exponential cathodic phase and an increasing exponential anodic
phase. FIG. 15B is a plot 1520 showing a biphasic waveform with a
decreasing exponential cathodic phase and a decreasing exponential
anodic phase. FIG. 15C is a plot 1530 showing a biphasic waveform
with a decreasing exponential cathodic phase and a rectangular
anodic phase. FIG. 15D is a plot 1540 showing a biphasic waveform
with an increasing exponential cathodic phase and an increasing
exponential anodic phase. FIG. 15E is a plot 1550 showing a
biphasic waveform with an increasing exponential cathodic phase and
a decreasing exponential anodic phase. FIG. 15F is a plot 1560
showing a biphasic waveform with an increasing exponential cathodic
phase and a rectangular anodic phase. FIG. 15G is a plot 1570
showing the waveform energy at the spike threshold of activating a
nerve fiber determined for pulse widths from 20 .mu.s to 170 .mu.s
for each waveform of plots 1510-1560. In particular, curve 1532,
which corresponds to the shape of plot 1530, showed the highest
energy saving among the shapes shown in plots 1510-1560. Negative
energy in the plots corresponded to energy savings.
[0169] In other calculations included varying the time constant for
exponentially decreasing cathodic phases. As the time constant
became smaller the energy savings increased. For example, a time
constant of 10% of the pulse width 150 .mu.s of the cathodic phase
showed about a 60% energy saving compared to a biphasic rectangular
waveform.
[0170] Experiments were carried out to measure the power
consumption of waveform stimulator 1240 shown in FIG. 12. A two
second audio ("her husband brought some flowers") was played.
Measurements were collected with the sound processor circuit 1230
in 8-, 6-, and 4-channel modes, and stimulation phase widths of 25
.mu.s, 31.25 .mu.s, and 50 .mu.s for four different waveform
shapes:
[0171] (a) rect/rect: rectangular cathodic phase/rectangular anodic
phase;
[0172] (b) dexp/iexp: decreasing exponential cathodic
phase/increasing exponential anodic phase;
[0173] (c) dexp/rect: decreasing exponential cathodic
phase/rectangular anodic phase; and
[0174] (d) waveform determined by a genetic algorithm.
The magnitudes of the waveforms were scaled to achieve the same
neural response based on nerve fiber simulations. Measurement
results are shown in FIGS. 16A-C which are a series of plots of
measured power consumption for generating pulses of various
waveforms. FIG. 16A is a plot 1610 showing the measured power
consumption for phase width of 25 .mu.s. FIG. 16B is a plot 1620
showing the measured power consumption for phase width of 31.25
.mu.s. FIG. 16C is a plot 1630 showing the measured power
consumption for phase width of 50 .mu.s. Waveforms (a)-(d) are
labeled 1601, 1602, 1603, and 1604, respectively. For all waveforms
(a)-(d), power consumption increased with larger pulse width and
the number of channels because the current source was active for a
longer duration. Waveforms (b)-(d) had led to smaller power
consumption than waveform (a) for the same pulse width and number
of channels. The waveform (d) of the genetic algorithm was the most
power efficient compared to waveforms (a)-(c) and provided a power
saving of 22% at pulse width of 25 .mu.s and 29% at pulse width of
50 .mu.s.
OTHER EMBODIMENTS
[0175] It is to be understood that while the invention has been
described in conjunction with the detailed description thereof, the
foregoing description is intended to illustrate and not limit the
scope of the invention, which is defined by the scope of the
appended claims. Other aspects, advantages, and modifications are
within the scope of the following claims.
* * * * *