U.S. patent application number 17/663555 was filed with the patent office on 2022-09-01 for high duty cycle electrical stimulation therapy.
The applicant listed for this patent is Medtronic, Inc.. Invention is credited to Lisa M. Johanek.
Application Number | 20220273949 17/663555 |
Document ID | / |
Family ID | 1000006333061 |
Filed Date | 2022-09-01 |
United States Patent
Application |
20220273949 |
Kind Code |
A1 |
Johanek; Lisa M. |
September 1, 2022 |
HIGH DUTY CYCLE ELECTRICAL STIMULATION THERAPY
Abstract
In some examples, a medical device is configured to deliver high
dose electrical stimulation therapy to a patient by at least
generating and delivering an electrical stimulation signal having a
relatively high duty cycle, and a stimulation intensity less than a
perception or paresthesia threshold intensity level for the
patient. The pulses of the electrical stimulation signal may each
have a relatively low amplitude, but due at least in part to a
relatively high number of pulses per unit of time, a dose of the
electrical stimulation may be high enough to elicit a therapeutic
response from the patient.
Inventors: |
Johanek; Lisa M.; (White
Bear Lake, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic, Inc. |
Minneapolis |
MN |
US |
|
|
Family ID: |
1000006333061 |
Appl. No.: |
17/663555 |
Filed: |
May 16, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16061930 |
Jun 13, 2018 |
11331489 |
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PCT/US2016/066935 |
Dec 15, 2016 |
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17663555 |
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62269768 |
Dec 18, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/36071 20130101;
A61N 1/36171 20130101; A61N 1/36107 20130101; A61N 1/36007
20130101; A61N 1/36064 20130101; A61N 1/36062 20170801; A61N
1/36175 20130101; A61N 1/36178 20130101; A61N 1/3615 20130101; A61N
1/36167 20130101; A61N 1/36067 20130101 |
International
Class: |
A61N 1/36 20060101
A61N001/36 |
Claims
1. A method comprising: determining a paresthesia or perception
threshold for a patient; determining, for a selected frequency of
an electrical stimulation signal, a strength-duration curve based
on the paresthesia or perception threshold; and determining, by
processing circuitry and based on the strength-duration curve, a
set of one or more electrical stimulation parameter values for
generating the electrical stimulation signal having stimulation
intensity less than at least one of the perception threshold or the
paresthesia threshold of the patient, and having a duty cycle in a
range of about 5% to about 50%, a frequency in a range of about 1
Hertz to about 1400 Hertz, and a pulse width in a range of about
0.1 millisecond to about 5 milliseconds.
2. The method of claim 1, wherein the frequency is in a range of
about 1 Hertz to about 1000 Hertz.
3. The method of claim 1, wherein the pulse width is in a range of
about 0.1 millisecond to about 1 millisecond.
4. The method of claim 1, wherein the duty cycle is in a range of
about 10% to about 40%.
5. The method of claim 1, wherein the duty cycle is an on-time of
the pulses per second.
6. The method of claim 1, wherein determining the set of one or
more electrical stimulation parameter values comprises determining
a plurality of therapy programs each including a respective
electrode combination, the method further comprising delivering the
electrical stimulation signal to the patient by at least
interleaving delivery of electrical stimulation according to the
plurality of therapy programs.
7. The method of claim 1, wherein the pulses have substantially the
same pulse width.
8. The method of claim 1, wherein at least two of the pulses have
different pulse widths.
9. The method of claim 1, wherein the strength-duration curve
defines a relationship between amplitude and pulse width for the
selected frequency.
10. The method of claim 1, further comprising delivering the
electrical stimulation signal according to the set of one or more
electrical stimulation parameter values.
11. A system comprising: processing circuitry configured to:
determine a paresthesia or perception threshold stimulation
intensity level of a patient, determine, for a selected frequency,
a strength-duration curve based on the paresthesia or perception
threshold stimulation intensity level, and determine, based on the
strength-duration curve, a set of one or more electrical
stimulation parameter values for generating an electrical
stimulation signal having stimulation intensity less than at least
one of the perception threshold or the paresthesia threshold of the
patient, and having a duty cycle in a range of about 5% to about
50%, a frequency in a range of about 1 Hertz to about 1400 Hertz,
and a pulse width in a range of about 0.1 millisecond to about 5
milliseconds.
12. The system of claim 11, wherein the frequency is in a range of
about 1 Hertz to about 1000 Hertz.
13. The system of claim 11, wherein the pulse width is in a range
of about 0.1 millisecond to about 1 millisecond.
14. The system of claim 11, wherein the duty cycle is in a range of
about 10% to about 40%.
15. The system of claim 11, wherein the processing circuitry is
configured to determine the set of one or more electrical
stimulation parameter values by at least determining a plurality of
therapy programs each including a respective electrode combination,
the method further comprising delivering the electrical stimulation
signal to the patient by at least interleaving delivery of
electrical stimulation according to the plurality of therapy
programs.
16. The system of claim 11, wherein the pulses have substantially
the same pulse width.
17. The system of claim 11, wherein at least two of the pulses have
different pulse widths.
18. The system of claim 11, wherein the strength-duration curve
defines a relationship between amplitude and pulse width for the
selected frequency.
19. The system of claim 11, further comprising a stimulation
generator, wherein the processing circuitry is configured to
control the stimulation generator to deliver the electrical
stimulation signal according to the set of one or more electrical
stimulation parameter values.
20. A non-transitory computer readable medium comprising
instructions that, when executed by processing circuitry, cause the
processing circuitry to: determine a paresthesia or perception
threshold stimulation intensity level of a patient, determine, for
a selected frequency, a strength-duration curve based on the
paresthesia or perception threshold stimulation intensity level,
and determine, based on the strength-duration curve, a set of one
or more electrical stimulation parameter values for generating an
electrical stimulation signal having stimulation intensity less
than at least one of the perception threshold or the paresthesia
threshold of the patient, and having a duty cycle in a range of
about 5% to about 50%, a frequency in a range of about 1 Hertz to
about 1400 Hertz, and a pulse width in a range of about 0.1
millisecond to about 5 milliseconds.
Description
[0001] This application is a divisional of U.S. patent application
Ser. No. 16/061,930, filed Jun. 13, 2018, which is a national stage
of International Patent Application No. PCT/US2016/066935, filed
Dec. 15, 2016, which claims the benefit of U.S. Provisional Patent
Application No. 62/269,768, filed Dec. 18, 2015, the entire content
of each application is incorporated herein by reference.
BACKGROUND
[0002] The disclosure relates to electrical stimulation
therapy.
BACKGROUND
[0003] Medical devices may be external or implanted, and may be
used to deliver electrical stimulation therapy to patients to
various tissue sites to treat a variety of symptoms or conditions
such as chronic pain, tremor, Parkinson's disease, epilepsy,
urinary or fecal incontinence, sexual dysfunction, obesity, or
gastroparesis. A medical device may deliver electrical stimulation
therapy via one or more leads that include electrodes located
proximate to target locations associated with the brain, the spinal
cord, pelvic nerves, peripheral nerves, or the gastrointestinal
tract of a patient. Hence, electrical stimulation may be used in
different therapeutic applications, such as deep brain stimulation
(DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric
stimulation, or peripheral nerve field stimulation (PNFS).
[0004] A clinician may select values for a number of programmable
parameters in order to define the electrical stimulation therapy to
be delivered by the implantable stimulator to a patient. For
example, the clinician may select one or more electrodes, a
polarity of each selected electrode, a voltage or current
amplitude, a pulse width, and a pulse frequency as stimulation
parameters. A set of parameters, such as a set including electrode
combination, electrode polarity, amplitude, pulse width and pulse
rate, may be referred to as a program in the sense that they define
the electrical stimulation therapy to be delivered to the
patient.
SUMMARY
[0005] This disclosure describes example medical devices, systems,
and techniques for delivering a relatively high dose of electrical
stimulation therapy to a patient per unit of time to treat one or
more patient conditions. In some examples, a medical device is
configured to deliver the high dose of electrical stimulation
therapy by at least generating and delivering an electrical
stimulation signal having a relatively high duty cycle, and
stimulation intensity less than a perception or paresthesia
threshold intensity level of the patient. The electrical
stimulation therapy may comprise stimulation pulses that may each
have relatively low amplitude. Due at least in part to a relatively
high number of pulses per unit of time (e.g., per second) and the
resulting relatively high energy delivery per unit of time, the
dose of the electrical stimulation delivered to the patient may be
high enough to elicit a therapeutic response from the patient.
[0006] In some examples, the electrical stimulation may have a duty
cycle in a range of about 5% to about 50% and a frequency in a
range about 1 Hertz (Hz) to about 1400 Hz, such as less than about
1000 Hz, and each of the pulses may have a pulse width less than or
equal to about 5 milliseconds (ms), such as in a range of about 0.1
ms to about 5 ms, or in a range of about 0.1 ms to about 1 ms. In
these examples, the frequency and pulse width may be selected such
that the electrical stimulation may have a duty cycle in a range of
about 5% to about 50%. In addition, the frequency, amplitude, and
pulse width may be selected such that the stimulation intensity
less than at least one of a perception threshold intensity level or
a paresthesia threshold intensity level of the patient.
[0007] In some examples, the medical device may deliver a recharge
signal (e.g., one or more pulses or other waveforms) to the patient
after delivering the electrical stimulation signal having the
relatively high duty cycle. Each electrical stimulation pulse has a
first polarity and the recharge signal has a second polarity that
is opposite to the first polarity. For example, in some examples,
the medical device may deliver one or more recharge pulses to the
patient after delivering a plurality of pulses of the electrical
stimulation signal having the relatively high duty cycle. In this
case, a plurality of stimulation pulses may be delivered without
delivery of a recharge pulses between the stimulation pulses, but
then the plurality of stimulation pulses may be followed by one or
more recharge pulses.
[0008] In one example, a method includes generating, by a medical
device, an electrical stimulation signal comprising a plurality of
pulses and having a duty cycle in a range of about 5% to about 50%
and a frequency in a range of about 1 Hertz to about 1400 Hertz,
wherein each of the pulses has a pulse width in a range of about
0.1 millisecond to about 5 milliseconds, the electrical stimulation
signal having a stimulation intensity less than of at least one of
a perception threshold or a paresthesia threshold of a patient; and
delivering, by the medical device, the electrical stimulation
signal to the patient.
[0009] In another example, a method comprises generating, by a
medical device, a first electrical stimulation signal according to
a first therapy program, the first electrical stimulation signal
comprising a first plurality of electrical stimulation pulses;
generating, by the medical device, a second electrical stimulation
signal according to a second therapy program, the second electrical
stimulation signal comprising a second plurality of electrical
stimulation pulses, wherein each pulse of the first and second
electrical stimulation signals has a pulse width in a range of
about 0.1 millisecond to about 5 milliseconds; delivering, by the
medical device, the first and second electrical stimulation signals
to a patient via respective subsets of electrodes to generate first
and second stimulation fields; and delivering, by the medical
device, a recharge signal following the delivery of at least one
pulse of each of the first and second electrical stimulation
signals. Delivering the first and second electrical stimulation
signals comprises interleaving delivery of the first and second
electrical stimulation signals to deliver electrical stimulation
pulses at a frequency in a range of about 1 Hertz to about 1400
Hertz. The first and second stimulation fields, individually and
when overlapping, have stimulation intensities less than at least
one of: a perception threshold or a paresthesia threshold of the
patient.
[0010] In another example, a method comprises determining a
paresthesia or perception threshold for a patient; determining, for
a selected frequency, a strength-duration curve based on the
paresthesia or perception threshold; and determining, based on the
strength-duration curve, a set of one or more electrical
stimulation parameter values for generating an electrical
stimulation signal having stimulation intensity less than at least
one of the perception threshold or the paresthesia threshold of the
patient, and having a duty cycle in a range of about 5% to about
50%, a frequency in a range of about 1 Hertz to about 1400 Hertz,
and a pulse width in a range of about 0.1 millisecond to about 5
milliseconds.
[0011] In another example, a system a stimulation generator
configured to generate and deliver electrical stimulation therapy
to a patient; and a processor configured to control the stimulation
generator to generate and deliver an electrical stimulation signal
comprising a plurality of pulses and having a duty cycle in a range
of about 5% to about 50% and a frequency in a range of about 1
Hertz to about 1400 Hertz, wherein each of the pulses has a pulse
width in a range of about 0.1 millisecond to about 5 milliseconds,
the electrical stimulation signal having a stimulation intensity
less than at least one of a perception threshold or a paresthesia
threshold of the patient.
[0012] In another example, a system comprises a plurality of
electrodes; a stimulation generator configured to generate and
deliver electrical stimulation therapy to a patient via one or more
subset of the electrodes; and a processor configured to control the
stimulation generator to generate a first electrical stimulation
signal according to a first therapy program, the first electrical
stimulation signal comprising a first plurality of electrical
stimulation pulses, generate a second electrical stimulation signal
according to a second therapy program, the second electrical
stimulation signal comprising a second plurality of electrical
stimulation pulses, wherein each pulse of the first and second
electrical stimulation signals has a pulse width in a range of
about 0.1 millisecond to about 5 milliseconds, deliver the first
and second electrical stimulation signals to a patient via
respective subsets of electrodes to generate first and second
stimulation fields, wherein the processor is configured to control
the stimulation generator to deliver the first and second
electrical stimulation signals by at least interleaving delivery of
the first and second electrical stimulation signals to deliver
electrical stimulation pulses at a frequency in a range of about 1
Hertz to about 1400 Hertz, and deliver a recharge signal following
the delivery of at least one pulse of each of the first and second
electrical stimulation signals. The first and second stimulation
fields, individually and when overlapping, have stimulation
intensities less than at least one of: a perception threshold or a
paresthesia threshold of the patient.
[0013] In another example, a system comprises a processor
configured to determine a paresthesia or perception threshold
stimulation intensity level of a patient, determine, for a selected
frequency, a strength-duration curve based on the paresthesia or
perception threshold stimulation intensity level, and determine,
based on the strength-duration curve, a set of one or more
electrical stimulation parameter values for generating an
electrical stimulation signal having stimulation intensity less
than at least one of the perception threshold or the paresthesia
threshold of the patient, and having a duty cycle in a range of
about 5% to about 50%, a frequency in a range of about 1 Hertz to
about 1400 Hertz, and a pulse width in a range of about 0.1
millisecond to about 5 milliseconds.
[0014] In another example, a system includes means for generating
an electrical stimulation signal comprising a plurality of pulses
and having a duty cycle in a range of about 5% to about 50% and a
frequency in a range of about 1 Hertz to about 1400 Hertz, wherein
each of the pulses has a pulse width in a range of about 0.1
millisecond to about 5 milliseconds, the electrical stimulation
signal having a stimulation intensity less than at least one of a
perception threshold or a paresthesia threshold of a patient; and
means for delivering the electrical stimulation signal to the
patient.
[0015] In another example, a system includes means for generating a
first electrical stimulation signal according to a first therapy
program, the first electrical stimulation signal comprising a first
plurality of electrical stimulation pulses, and a second electrical
stimulation signal according to a second therapy program, the
second electrical stimulation signal comprising a second plurality
of electrical stimulation pulses, wherein each pulse of the first
and second electrical stimulation signals has a pulse width in a
range of about 0.1 millisecond to about 5 milliseconds; means for
delivering the first and second electrical stimulation signals to a
patient via respective subsets of electrodes to generate first and
second stimulation fields, wherein the means for delivering
delivers the first and second electrical stimulation signals by at
least interleaving delivery of the first and second electrical
stimulation signals to deliver electrical stimulation pulses at a
frequency in a range of about 1 Hertz to about 1400 Hertz; and
means for delivering a recharge signal following the delivery of at
least one pulse of each of the first and second electrical
stimulation signals. The first and second stimulation fields,
individually and when overlapping, have stimulation intensities
less than at least one of: a perception threshold or a paresthesia
threshold of the patient.
[0016] In another example, a system includes means for determining
a paresthesia or perception threshold for a patient; means for
determining, for a selected frequency, a strength-duration curve
based on the paresthesia or perception threshold; and means for
determining, based on the strength-duration curve, a set of one or
more electrical stimulation parameter values for generating an
electrical stimulation signal having stimulation intensity less
than at least one of the perception threshold or the paresthesia
threshold of the patient, and having a duty cycle in a range of
about 20% to about 50%, a frequency in a range of about 1 Hertz to
about 1400 Hertz, and a pulse width in a range of about 0.1
millisecond to about 5 milliseconds.
[0017] In another example, a computer-readable storage medium
comprises instructions that, when executed by a processor, cause
the processor to: control a stimulation generator to generate an
electrical stimulation signal comprising a plurality of pulses and
having a duty cycle in a range of about 5% to about 50% and a
frequency in a range of about 1 Hertz to about 1400 Hertz, wherein
each of the pulses has a pulse width in a range of about 0.1
millisecond to about 5 milliseconds, the electrical stimulation
signal having a stimulation intensity less than at least one of a
perception threshold or a paresthesia threshold of a patient; and
control the stimulation generator to deliver the electrical
stimulation signal to the patient.
[0018] In another example, a computer-readable storage medium
comprises instructions that, when executed by a processor, cause
the processor to control a stimulation generator of a medical
device to generate a first electrical stimulation signal according
to a first therapy program, the first electrical stimulation signal
comprising a first plurality of electrical stimulation pulses;
control the stimulation generator of the medical device to generate
a second electrical stimulation signal according to a second
therapy program, the second electrical stimulation signal
comprising a second plurality of electrical stimulation pulses,
wherein each pulse of the first and second electrical stimulation
signals has a pulse width in a range of about 0.1 millisecond to
about 5 milliseconds; control the stimulation generator to deliver
the first and second electrical stimulation signals to a patient
via respective subsets of electrodes to generate first and second
stimulation fields by at least interleaving delivery of the first
and second electrical stimulation signals to deliver electrical
stimulation pulses at a frequency in a range of about 1 Hertz to
about 1400 Hertz; and control the stimulation generator to deliver
a recharge signal following the delivery of at least one pulse of
each of the first and second electrical stimulation signals. The
first and second stimulation fields, individually and when
overlapping, have stimulation intensities less than at least one
of: a perception threshold or a paresthesia threshold of the
patient.
[0019] In another example, a computer-readable storage medium
comprises instructions that, when executed by a processor, cause
the processor to: determine a paresthesia or perception threshold
for a patient; determine, for a selected frequency, a
strength-duration curve based on the paresthesia or perception
threshold; and determine, based on the strength-duration curve, a
set of one or more electrical stimulation parameter values for
generating an electrical stimulation signal having stimulation
intensity less than at least one of the perception threshold or the
paresthesia threshold of the patient, and having a duty cycle in a
range of about 5% to about 50%, a frequency in a range of about 1
Hertz to about 1400 Hertz, and a pulse width in a range of about
0.1 millisecond to about 5 milliseconds.
[0020] In another aspect, the disclosure is directed to a
computer-readable storage medium, which may be an article of
manufacture. The computer-readable storage medium includes
computer-readable instructions for execution by one or more
processors. The instructions cause one or more processors to
perform any part of the techniques described herein. The
instructions may be, for example, software instructions, such as
those used to define a software or computer program.
[0021] The details of one or more examples are set forth in the
accompanying drawings and the description below. Other features,
objects, and advantages of examples according to this disclosure
will be apparent from the description and drawings, and from the
claims.
BRIEF DESCRIPTION OF DRAWINGS
[0022] FIG. 1 is a conceptual diagram illustrating an example
system that includes a medical device programmer and an implantable
medical device (IMD) configured to deliver high dose electrical
stimulation therapy to a patient.
[0023] FIG. 2 is a block diagram of the example IMD of FIG. 1.
[0024] FIG. 3 is a block diagram of the example external programmer
of FIG. 1.
[0025] FIGS. 4 and 5 illustrate an example of high duty cycle
electrical stimulation waveforms.
[0026] FIG. 6 illustrates an example burst electrical stimulation
waveform.
[0027] FIG. 7 illustrates an example high frequency electrical
stimulation waveform.
[0028] FIG. 8 is a flow diagram of an example method of programming
high dose electrical stimulation therapy having a stimulation
intensity level that is less than a perception or paresthesia
threshold intensity level for a patient.
[0029] FIG. 9 is a flow diagram of an example method of determining
a perception or paresthesia threshold intensity level for a
patient.
DETAILED DESCRIPTION
[0030] This disclosure describes example medical devices, systems,
and techniques for delivering electrical stimulation therapy to
treat one or more patient conditions, the electrical stimulation
therapy providing a relatively high amount of electrical
stimulation per unit of time (referred to herein as a "high dose")
and a stimulation intensity less than a perception or paresthesia
threshold intensity level of the patient. The dose of electrical
stimulation may be a function of a frequency and pulse width of the
pulses. The perception threshold intensity level may be the lowest
determined stimulation intensity level at which a patient
perception of the electrical stimulation occurs, and the
paresthesia threshold intensity level may be the lowest determined
stimulation intensity level at which the electrical stimulation
causes paresthesia, for example, within a predetermined time range
(e.g., 30 seconds) of the patient receiving the electrical
stimulation.
[0031] The high dose of electrical stimulation therapy described
herein delivers a relatively high amount of energy (e.g.,
electrical charge) to tissue of the patient per unit of time (e.g.,
one second). For example, the high dose of electrical stimulation
therapy may have a charge delivery of about 100 microCoulombs to
about 2,000 microCoulombs per second. The sufficiency of electrical
stimulation in producing a desired therapeutic effect may be based
on the amount of charge delivered to the tissue of the patient per
unit of time. In the case of electrical stimulation pulses, the
amount of charge delivered to the tissue of the patient per unit of
time may be calculated by multiplying the electrical current
delivered during an electrical pulse by the pulse width, which
yields the amount of electrical charge delivered during a single
pulse, and multiplying the amount of electrical charge delivered to
the patient for one pulse by the frequency of the electrical
stimulation signal.
[0032] The high energy dose electrical stimulation described herein
may be provided by an electrical stimulation signal having a
relatively high duty cycle. The duty cycle may be, for example, the
percentage of active electrical stimulation per unit of time (e.g.,
one second), and may, for example, be a product of a frequency of
the pulses and a pulse width of the pulses. Thus, the duty cycle
may, in some examples, by defined by a plurality of pulses per unit
of time, rather than a single pulse. However, other waveforms may
be used in other examples.
[0033] In some examples, a medical device is configured to generate
and deliver, via one or more electrodes, an electrical stimulation
signal having a high duty cycle and a frequency less than or equal
to about 1400 Hertz (Hz), such as less than or equal to about 1000
Hz. The frequency may, for example, be in a range of about 1 Hz to
about 1400 Hz, such as about 1000 Hz. The pulses may each have a
relatively low amplitude (e.g., about 1 milliamp (mA) to about 25
mA, such as about 1 mA to about 5 mA), which can be the same or may
vary between the pulses. In some examples, the duty cycle may be
greater than 5% such as in a range of about 5% to about 50%, or
about 20% to about 50%, or about 10% to about 40%, or about 20% to
about 30%. Thus, in some examples, the frequency and pulse width of
the pulses may be selected such that the electrical stimulation may
have a duty cycle in a range of about 5% to about 50%, where the
frequency is selected to be in a range of about 1 Hz to about 1400
Hz (e.g., less than or equal to about 1000 Hz) and the pulse width
is selected to be in a range of about 0.1 ms to about 5 ms (e.g.,
about 0.1 ms to about 1 ms). In some examples, the amplitude of the
pulses may be selected to provide therapeutic efficacy and so that
the intensity of the delivered electrical stimulation is less than
or equal to one or both of a paresthesia threshold or perception
threshold of the patient.
[0034] Due at least in part to a relatively high number of pulses
per unit of time and the selected pulse width, the dose (e.g.,
charge per second delivered) of the electrical stimulation signal
may be high enough to elicit a therapeutic response from the
patient, even though each individual pulse may have a relatively
low amplitude. The relatively low amplitude of the pulses may also
help keep the stimulation intensity level less than a perception or
paresthesia threshold intensity level for the patient. In some
examples, the plurality of pulses may have a duty cycle in a range
of about 5% to about 50% and a frequency less than or equal to
about 1000 Hz, and each of the pulses may have a pulse width in a
range of about 0.1 ms to about 5 ms, such as about 0.1 ms to about
1 ms, or about 500 .mu.s to about 1 ms. For example, the plurality
of pulses may have a duty cycle in a range of about 5% to about 50%
and a frequency less equal to about 1000 Hz, and each of the pulses
may have a pulse width less than or equal to about 0.5 ms.
[0035] In some examples in which the high duty cycle, relatively
low stimulation intensity electrical stimulation is delivered to a
tissue site in a patient proximate to the spinal cord, the
electrical stimulation may modulate nerve fibers and produce pain
relief via mechanisms that do not rely on the activation of dorsal
column fibers. Although the electrical stimulation may or may not
also activate dorsal column fibers, the electrical stimulation may
not rely on activation of dorsal column fibers, which may cause
paresthesia, to provide therapeutic efficacy for pain or another
patient condition. For example, the high duty cycle electrical
stimulation may block endogenous action potentials in A-beta fibers
at their branch points. A-beta fibers may be involved in some forms
of chronic pain modulation, and the high duty cycle electrical
stimulation may prevent A-fiber information from reaching the
dorsal horn. Activation of dorsal column axons may cause
paresthesia. Thus, the pain relief from the high duty cycle
electrical stimulation described herein using relatively low
amplitude pulses may be substantially paresthesia-free in some
examples and with some patients. The paresthesia free electrical
stimulation may be referred to as subliminal stimulation in some
examples.
[0036] In some cases, the high duty cycle electrical stimulation
described herein may modulate dural fibers, which may also be
responsible for some aspects of pain (e.g., back pain) without
causing activation of dorsal column fibers.
[0037] The mechanisms by which the high duty cycle, relatively low
stimulation intensity electrical stimulation described herein may
cause pain relief may include inhibition of spinal neurons,
modulation of the activity of the central nervous system (CNS)
and/or brainstem, or descending inhibition (e.g., suppression of
pain messages to the brain).
[0038] The high duty cycle electrical stimulation techniques
described herein may activate neurons in a different way than burst
electrical stimulation techniques. In contrast to burst electrical
stimulation techniques, the high duty cycle electrical stimulation
described herein may provide better targeting of target tissue
sites. For a given electrical stimulation dose (e.g., energy per
second), burst electrical stimulation techniques may result in
activation of more neural tissue (e.g., a larger volume of tissue)
than the electrical stimulation described herein, which provides
electrical stimulation with a higher frequency to achieve a dose
sufficient to elicit a therapeutic response from a patient.
[0039] For example, the high duty cycle electrical stimulation
described herein may deliver pulses having higher amplitudes,
shorter pulse widths, or both higher amplitudes and shorter pulse
widths than the burst electrical stimulation techniques. Compared
to burst electrical stimulation techniques, the higher duty cycle
described herein may allow for a larger therapeutic window for the
amplitude of electrical stimulation (e.g., a range of values of the
stimulation signal amplitude that provides efficacious electrical
stimulation therapy), which may result in more freedom to titrate
the amplitude of the pulses. The larger therapeutic window may help
a clinician tailor the electrical stimulation to a particular
patient to allow for different neural mechanisms to be activated in
order to elicit a therapeutic response from the patient, e.g.,
while maintaining the intensity of the electrical stimulation below
a threshold stimulation intensity level. In addition, the larger
therapeutic window for the amplitude may provide a clinician with
more freedom to select therapy parameter values that balance power
efficiency (power consumed by the IMD when generating the
electrical stimulation) with the therapeutic effect.
[0040] In some examples, a therapeutic window is defined as the
values of an electrical stimulation parameter between an efficacy
threshold, which may be the lowest electrical stimulation parameter
value (or highest, depending on the parameter) at which efficacious
effects of the electrical stimulation were first observed for a
particular patient, and an adverse-effects threshold, which may be
the lowest electrical stimulation parameter value (or highest,
depending on the parameter) at which adverse effects of the
electrical stimulation were first observed for the patient.
[0041] The high duty cycle electrical stimulation described herein
may also provide better targeting of target tissue sites compared
to high frequency electrical stimulation techniques, in which a
plurality of pulses are delivered at frequencies greater than or
equal to 1.5 kilohertz (kHz). For a given dose, the high frequency
electrical stimulation techniques may result in activation of more
neural tissue than the high duty cycle electrical stimulation
described herein, which provides electrical stimulation with wider
pulse widths, but at lower frequencies than the high frequency
electrical stimulation techniques to achieve a dose sufficient to
elicit a therapeutic response from a patient. Compared to high
frequency electrical stimulation techniques, the lower frequency of
the high duty cycle electrical stimulation described herein may
allow for a larger therapeutic window for the amplitude of
electrical stimulation. As discussed above, a larger therapeutic
window may help a clinician tailor the electrical stimulation to a
particular patient and may provide the clinician with more freedom
to select therapy parameter values that balance power efficiency
with the therapeutic effect.
[0042] FIG. 1 is a conceptual diagram illustrating example system
10 that includes an implantable medical device (IMD) 14 configured
to deliver electrical stimulation therapy to patient 12. In the
example shown in FIG. 1, IMD 14 is configured to deliver SCS
therapy. Although the techniques described in this disclosure are
generally applicable to a variety of medical devices including
external and implantable medical devices (IMDs), application of
such techniques to IMDs and, more particularly, implantable
electrical stimulators (e.g., neurostimulators) will be described
for purposes of illustration. More particularly, the disclosure
will refer to an implantable spinal cord stimulation (SCS) system
for purposes of illustration, but without limitation as to other
types of medical devices or other therapeutic applications of
medical devices.
[0043] As shown in FIG. 1, system 10 includes an IMD 14, leads 16A,
16B, and external programmer 18 shown in conjunction with a patient
12, who is ordinarily a human patient. In the example of FIG. 1,
IMD 14 is an implantable electrical stimulator that is configured
to generate and deliver electrical stimulation therapy to patient
12 via electrodes of leads 16A, 16B, e.g., for relief of chronic
pain or other symptoms. IMD 14 may be a chronic electrical
stimulator that remains implanted within patient 12 for weeks,
months, or even years. In other examples, IMD 14 may be a
temporary, or trial, stimulator used to screen or evaluate the
efficacy of electrical stimulation for chronic therapy.
[0044] IMD 14 may be constructed of any polymer, metal, or
composite material sufficient to house the components of IMD 14
(e.g., components illustrated in FIG. 2) within patient 12. In this
example, IMD 14 may be constructed with a biocompatible housing,
such as titanium or stainless steel, or a polymeric material such
as silicone, polyurethane, or a liquid crystal polymer, and
surgically implanted at a site in patient 12 near the pelvis,
abdomen, or buttocks. In other examples, IMD 14 may be implanted
within other suitable sites within patient 12, which may depend,
for example, on the target site within patient 12 for the delivery
of electrical stimulation therapy. The outer housing of IMD 14 may
be configured to provide a hermetic seal for components, such as a
rechargeable power source. In addition, in some examples, the outer
housing of IMD 14 may be selected of a material that facilitates
receiving energy to charge the rechargeable power source.
[0045] Electrical stimulation energy, which may be constant current
or constant voltage based pulses, for example, is delivered from
IMD 14 to one or more target tissue sites of patient 12 via one or
more electrodes (not shown) of implantable leads 16A and 16B
(collectively "leads 16"). In the example of FIG. 1, leads 16 carry
electrodes that are placed adjacent to the target tissue of spinal
cord 20. One or more of the electrodes may be disposed at a distal
tip of a lead 16 and/or at other positions at intermediate points
along the lead. Leads 16 may be implanted and coupled to IMD 14.
The electrodes may transfer electrical stimulation generated by an
electrical stimulation generator in IMD 14 to tissue of patient 12.
Although leads 16 may each be a single lead, each lead 16 may
include a lead extension or other segments that may aid in
implantation or positioning of the respective lead 16. In some
other examples, IMD 14 may be a leadless stimulator with one or
more arrays of electrodes arranged on a housing of the stimulator
rather than leads that extend from the housing. In addition, in
some other examples, system 10 may include one lead or more than
two leads, each coupled to IMD 14 and directed to similar or
different target tissue sites.
[0046] The electrodes of leads 16 may be electrode pads on a paddle
lead, circular (e.g., ring) electrodes surrounding the body of the
lead, conformable electrodes, cuff electrodes, segmented electrodes
(e.g., electrodes disposed at different circumferential positions
around the lead instead of a continuous ring electrode), or any
other type of electrodes capable of forming unipolar, bipolar or
multipolar electrode combinations for therapy. Ring electrodes
arranged at different axial positions at the distal ends of lead 16
will be described for purposes of illustration.
[0047] The deployment of electrodes via leads 16 is described for
purposes of illustration, but arrays of electrodes may be deployed
in different ways. For example, a housing associated with a
leadless stimulator may carry arrays of electrodes, e.g., rows
and/or columns (or other patterns), to which shifting operations
may be applied. Such electrodes may be arranged as surface
electrodes, ring electrodes, or protrusions. As a further
alternative, electrode arrays may be formed by rows and/or columns
of electrodes on one or more paddle leads. In some examples,
electrode arrays may include electrode segments, which may be
arranged at respective positions around a periphery of a lead,
e.g., arranged in the form of one or more segmented rings around a
circumference of a cylindrical lead.
[0048] The therapy parameters for a therapy program (also referred
to herein as a set of electrical stimulation parameter values) that
controls delivery of stimulation therapy by IMD 14 through the
electrodes of leads 16 may include information identifying which
electrodes have been selected for delivery of stimulation according
to the therapy program, the polarities of the selected electrodes,
i.e., the electrode configuration for the program, and voltage or
current amplitude, pulse rate, and pulse width of stimulation
delivered by the electrodes. Delivery of stimulation pulses will be
described for purposes of illustration. However, electrical
stimulation may be delivered in other forms such as continuous
waveforms. Programs that control delivery of other therapies by IMD
14 may include other parameters, e.g., such as rate or the like in
the case IMD 14 is also configured for drug delivery.
[0049] Although FIG. 1 is directed to SCS therapy, e.g., used to
treat pain, in other examples system 10 may be configured to treat
any other condition that may benefit from electrical stimulation
therapy. For example, system 10 may be used to treat tremor,
Parkinson's disease, epilepsy, a pelvic floor disorder (e.g.,
urinary incontinence or other bladder dysfunction, fecal
incontinence, pelvic pain, bowel dysfunction, or sexual
dysfunction), obesity, gastroparesis, or psychiatric disorders
(e.g., depression, mania, obsessive compulsive disorder, anxiety
disorders, and the like). In this manner, system 10 may be
configured to provide therapy taking the form of deep brain
stimulation (DBS), peripheral nerve stimulation (PNS), peripheral
nerve field stimulation (PNFS), cortical stimulation (CS), pelvic
floor stimulation, gastrointestinal stimulation, or any other
stimulation therapy capable of treating a condition of patient
12.
[0050] In some examples, lead 16 may include one or more sensors
configured to allow IMD 14 to monitor one or more parameters of
patient 12. The one or more sensors may be provided in addition to,
or in place of, therapy delivery by lead 16.
[0051] IMD 14 is configured to deliver high dose electrical
stimulation therapy to patient 12 via selected combinations of
electrodes carried by one or both of leads 16, alone or in
combination with an electrode carried by or defined by an outer
housing of IMD 14. The target tissue for the high dose electrical
stimulation therapy may be any tissue affected by electrical
stimulation, which may be in the form of electrical stimulation
pulses or continuous waveforms. In some examples, the target tissue
includes nerves, smooth muscle or skeletal muscle. In the example
illustrated by FIG. 1, the target tissue is tissue proximate spinal
cord 20, such as within an intrathecal space or epidural space of
spinal cord 20, or, in some examples, adjacent nerves that branch
off of spinal cord 20. Leads 16 may be introduced into spinal cord
18 in via any suitable region, such as the thoracic, cervical or
lumbar regions. Stimulation of spinal cord 18 may, for example,
prevent pain signals from traveling through spinal cord 20 and to
the brain of patient 12. Patient 12 may perceive the interruption
of pain signals as a reduction in pain and, therefore, efficacious
therapy results.
[0052] IMD 14 generates and delivers electrical stimulation therapy
to a target stimulation site within patient 12 via the electrodes
of leads 16 to patient 12 according to one or more therapy
programs. A therapy program defines values for one or more
parameters that define an aspect of the therapy delivered by IMD 14
according to that program. For example, a therapy program that
controls delivery of stimulation by IMD 14 in the form of pulses
may define values for voltage or current pulse amplitude, pulse
width, and pulse rate for stimulation pulses delivered by IMD 14
according to that program.
[0053] Moreover, in some examples, IMD 14 delivers electrical
stimulation therapy to patient 12 according to multiple therapy
programs, which may be stored as a therapy program group. For
example, as described below, in some examples, IMD 14 may deliver
different pulses of a high duty cycle electrical stimulation signal
via respective electrode combinations, and each of the electrode
combinations may be associated with a respective therapy program.
The therapy programs may be stored as a group, such that when IMD
14 generates and delivers electrical stimulation therapy via a
selected group, IMD 14 delivers high duty cycle electrical
stimulation signal via two or more therapy programs.
[0054] IMD 14 is configured to deliver a recharge signal (e.g., one
or more recharge pulses or other waveforms), which may help balance
a charge accumulation that may occur within tissue proximate the
electrodes used to deliver the electrical stimulation. The recharge
signal may also be referred to as a "recovery signal" or a "charge
balancing signal" and may have a polarity opposite to that of the
electrical stimulation signal generated and delivered by IMD 14.
While recharge pulses are primarily referred to herein, in other
examples, a recharge signal can have any suitable waveform.
[0055] In some examples, IMD 14 may deliver a recharge signal after
delivery of multiple pulses of a high duty electrical stimulation
signal, which may be defined by one therapy program or by multiple
therapy programs. Thus, rather than charge balancing on a
pulse-by-pulse basis (e.g., delivering one recharge pulse after
each electrical stimulation pulse), in some examples, IMD 14
delivers one or more recharge pulses after delivery of two or more
electrical stimulation pulses. In some examples, IMD 14 delivers a
high duty electrical stimulation signal to patient 12 according to
multiple therapy programs by at least interleaving pulses of two or
more therapy programs, the pulses having a first polarity. In some
of these examples, IMD 14 may wait to deliver one or more recharge
pulses until after one or more pulses of each of the therapy
programs are delivered, each recharge pulse having a second
polarity opposite to the first polarity. Thus, in some examples,
IMD 14 may not deliver any recharge signals between therapy
programs, but, rather, may withhold the delivery of one or more
recharge signals until after IMD 14 delivers a plurality of pulses
according to two or more therapy programs.
[0056] In some examples, IMD 14 is configured to generate and
deliver high duty cycle electrical stimulation therapy to patient
12 via two or more electrodes, e.g., of leads 16 and/or a housing
of IMD 14. In some examples, the high duty cycle electrical
stimulation signal may have a duty cycle in a range of about 5% to
about 50%, a frequency in a range of about 1 Hz to about 1400 Hz
(e.g., less than about 1000 Hz in some examples), and a pulse width
less than or equal to about 5 ms, such as about 0.1 ms to about 5
ms, or about 0.1 ms to about 1 ms. The amplitude and pulse width of
the electrical stimulation signal are selected such that a
stimulation intensity level of the electrical stimulation signal is
less than a perception or paresthesia threshold intensity level for
patient 12. For example, the amplitude may be selected to be in a
range of about 1 mA to about 25 mA, such as in a range of about 1
mA to about 5 mA.
[0057] In some examples, IMD 14 delivers the pulses of the high
duty cycle electrical stimulation signal via different electrode
combinations. For example, IMD 14 may alternate delivery of pulses
between two different electrode combinations, or may otherwise
interleave the pulses using two or more electrode combinations in
any suitable order. Regardless of the number of electrode
combinations with which IMD 14 delivers the pulses, however, the
combination of pulses delivered over time define an electrical
stimulation signal that may have a duty cycle in a range of about
5% to about 50% and a frequency in a range of about 1 Hz to about
1400 Hz.
[0058] A user, such as a clinician or patient 12, may interact with
a user interface of an external programmer 18 to program IMD 14.
Programming of IMD 14 may refer generally to the generation and
transfer of commands, programs, or other information to control the
operation of IMD 14. In this manner, IMD 14 may receive the
transferred commands and programs from programmer 18 to control
stimulation therapy. For example, external programmer 18 may
transmit therapy programs, stimulation parameter adjustments,
therapy program selections, therapy program group selections, user
input, or other information to control the operation of IMD 14,
e.g., by wireless telemetry or wired connection.
[0059] In some cases, external programmer 18 may be characterized
as a physician or clinician programmer if it is primarily intended
for use by a physician or clinician. In other cases, external
programmer 18 may be characterized as a patient programmer if it is
primarily intended for use by a patient. A patient programmer may
be generally accessible to patient 12 and, in many cases, may be a
portable device that may accompany patient 12 throughout the
patient's daily routine. For example, a patient programmer may
receive input from patient 12 when the patient wishes to terminate
or change stimulation therapy. In general, a physician or clinician
programmer may support selection and generation of programs by a
clinician for use by IMD 14, whereas a patient programmer may
support adjustment and selection of such programs by a patient
during ordinary use. In other examples, external programmer 18 may
be included, or part of, an external charging device that recharges
a power source of IMD 14. In this manner, a user may program and
charge IMD 14 using one device, or multiple devices.
[0060] As described herein, information may be transmitted between
external programmer 18 and IMD 14. Therefore, IMD 14 and programmer
18 may communicate via wireless communication using any techniques
known in the art. Examples of communication techniques may include,
for example, radiofrequency (RF) telemetry and inductive coupling,
but other techniques are also contemplated. In some examples,
programmer 18 may include a communication head that may be placed
proximate to the patient's body near the IMD 14 implant site in
order to improve the quality or security of communication between
IMD 14 and programmer 18. Communication between programmer 18 and
IMD 14 may occur during power transmission or separate from power
transmission.
[0061] Although IMD 14 is generally described herein, techniques of
this disclosure may also be applicable to external or partially
external medical device in other examples. For example, IMD 14 may
instead be configured as an external medical device coupled to one
or more percutaneous medical leads. The external medical device may
be a chronic, temporary, or trial electrical stimulator. In
addition, an external electrical stimulator may be used in addition
to one or more IMDs 14 to deliver electrical stimulation described
herein.
[0062] FIG. 2 is a functional block diagram illustrating various
components of an example IMD 14. In the example shown in FIG. 2,
IMD 14 includes processor 30, memory 32, stimulation generator 34,
telemetry module 36, and power source 38. In other examples, IMD 14
may include a greater or fewer number of components. For example,
IMD 14 may also include any one or more of a sensing module
configured to sense one or more patient parameters, an inductive
coil to receive power from an external charging device, and a
recharge module that manages recharging of power source 38.
[0063] Processor 30 is operably connected to and configured to
access information from memory 32 and to control stimulation
generator 34 and telemetry circuit 36. Components described as
processor 30 and other processors within IMD 14, external
programmer 20 or any other device described in this disclosure may
each comprise one or more processors, such as one or more
microprocessors, digital signal processors (DSPs), application
specific integrated circuits (ASICs), field programmable gate
arrays (FPGAs), programmable logic circuitry, or the like, either
alone or in any suitable combination. In general, IMD 14 may
comprise any suitable arrangement of hardware (e.g., circuitry),
alone or in combination with software and/or firmware, to perform
the various techniques described herein attributed to IMD 14 and
processor 30. In various examples, IMD 14 may include one or more
processors 30, such as one or more DSPs, ASICs, FPGAs, programmable
logic circuitry, or the like, either alone or in any suitable
combination.
[0064] Memory 32 may store therapy programs 40 (or other
instructions that specify therapy parameter values for the therapy
provided by stimulation generator 34 and IMD 14), operating
instructions 42 for execution by processor 30, and any other
information regarding therapy of patient 12. In some examples,
memory 32 may also store instructions for communication between IMD
14 and programmer 18, or any other instructions required to perform
tasks attributed to IMD 14. Memory 32 may include separate memories
for storing therapy programs, operating instructions, and any other
data that may benefit from separate physical memory modules.
[0065] Memory 32 may comprise any suitable, such as random access
memory (RAM), read only memory (ROM), programmable read only memory
(PROM), erasable programmable read only memory (EPROM),
electronically erasable programmable read only memory (EEPROM),
flash memory, comprising executable instructions for causing the
one or more processors to perform the actions attributed to them.
Although processor 30, therapy module 34, and telemetry module 36
are described as separate modules, in some examples, processor 30,
therapy module 34, and telemetry module 36 may be functionally
integrated. In some examples, processor 30, therapy module 34, and
telemetry module 36 may correspond to individual hardware units,
such as ASICs, DSPs, FPGAs, or other hardware units.
[0066] Stimulation generator 34 forms a therapy delivery module of
IMD 14. Processor 30 controls stimulation generator 34 to generate
and deliver electrical stimulation via electrode combinations
formed by a selected subset of electrodes 24A-24D, 26A-26D
(collectively, "electrodes 24, 26") of leads 16. Stimulation
generator 34 may deliver electrical stimulation therapy via
electrodes on one or more of leads 16, e.g., as stimulation pulses.
Stimulation generator 34 may include stimulation generation
circuitry to generate stimulation pulses and, in some examples,
switching circuitry to switch the stimulation across different
electrode combinations, e.g., in response to control by processor
30. In other examples, stimulation generator 34 may include
multiple current sources to drive more than one electrode
combination at one time.
[0067] In some examples, processor 30 controls stimulation
generator 34 by accessing memory 32 to selectively access and load
at least one of the therapy programs 40 to stimulation generator
34. The stimulation parameter values of the stored therapy programs
40 may include, for example, a voltage amplitude, a current
amplitude, a pulse frequency, a pulse width, a duty cycle, and a
subset of electrodes 24, 26 of leads 16 for delivering the
electrical stimulation signal. An electrode configuration may
include the one or more electrodes 24, 26 with which stimulation
generator 34 delivers the electrical stimulation to tissue of a
patient, and the associated electrode polarities.
[0068] In some examples, IMD 14 may deliver a high duty cycle
electrical stimulation signal to a target tissue site within
patient 12 via one electrode combination, such that all pulses are
delivered via the same electrode combination. In other examples,
IMD 14 may deliver a high duty cycle electrical stimulation signal
to a target tissue site within patient 12 via two or more electrode
combinations, such that IMD 14 delivers at least two different
pulses of a high duty cycle electrical stimulation signal via
respective electrode combinations. The delivery of different pulses
via respective electrode combinations may help target the
electrical stimulation to a target tissue site (e.g., in the case
of pain relief, the target may be towards a midline of spinal cord
20, for example, near the T9-T10 vertebrae). The electrical
stimulation delivered by each electrode combination, which may be
referred to as a sub-signal, may be interleaved (e.g., delivered at
different times) to define the high duty cycle electrical
stimulation signal. In some of these examples, each sub-signal is
associated with a respective therapy program. Thus, processor 30
may control stimulation generator 34 to generate and deliver a high
duty cycle electrical stimulation signal by at least accessing
memory 32 to selectively access and load multiple therapy programs
40 to stimulation generator 34.
[0069] IMD 14 also includes components to receive power from
programmer 18 or a separate charging device to recharge a battery
of power source 38. Power source 38 may include one or more
capacitors, batteries, or other energy storage devices. IMD 14 may
thus also include an inductive coil and a recharge module (both not
shown) configured to manage the recharging session for power source
38. Although inductive coupling may be used to recharge power
source 38, other wireless energy transfer techniques may
alternatively be used. Alternatively, power source 38 may not be
rechargeable.
[0070] Processor 30 may also control the exchange of information
with programmer 18 and/or an external programmer using telemetry
module 36. Telemetry module 36 may be configured for wireless
communication using RF protocols, inductive communication
protocols, or any other suitable technique. To support the wireless
communication, telemetry circuit 36 may include appropriate
electronic components, such as amplifiers, filters, mixers,
encoders, decoders, and the like. Processor 30 may transmit
operational information and receive therapy programs or therapy
parameter adjustments via telemetry module 36. Also, in some
examples, IMD 14 may communicate with other implanted devices, such
as stimulators, control devices, or sensors, via telemetry module
36.
[0071] FIG. 3 is a block diagram of an example external programmer
18. While programmer 18 may generally be described as a hand-held
device, programmer 18 may be a larger portable device or a more
stationary device in some examples. In addition, in other examples,
programmer 18 may be included as part of an external charging
device or include the functionality of an external charging device.
As illustrated in FIG. 3, programmer 18 may include a processor 50,
memory 52, user interface 54, telemetry module 56, and power source
58. Memory 52 may store instructions that, when executed by
processor 50, cause processor 50 and external programmer 18 to
provide the functionality ascribed to external programmer 18
throughout this disclosure.
[0072] Programmer 18 comprises any suitable arrangement of
hardware, alone or in combination with software and/or firmware, to
perform the techniques attributed to programmer 18, and processor
50, user interface 54, and telemetry module 56 of programmer 18. In
various examples, processor 50 may include one or more processors,
such as one or more microprocessors, DSPs, ASICs, FPGAs, or any
other equivalent integrated or discrete logic circuitry, as well as
any combinations of such components. Programmer 18 also, in various
examples, may include a memory 52, such as RAM, ROM, PROM, EPROM,
EEPROM, flash memory, a hard disk, a CD-ROM, comprising executable
instructions for causing the one or more processors to perform the
actions attributed to them. Moreover, although processor 50 and
telemetry module 56 are described as separate modules, in some
examples, processor 50 and telemetry module 56 are functionally
integrated. In some examples, processor 50 and telemetry module 56
correspond to individual hardware units, such as ASICs, DSPs,
FPGAs, or other hardware units.
[0073] Memory 52 may store instructions that, when executed by
processor 50, cause processor 50 and programmer 18 to provide the
functionality ascribed to programmer 18 throughout this disclosure.
In addition, in some examples, memory 52 stores one or more therapy
programs for execution by IMD 14 to deliver high dose electrical
stimulation therapy.
[0074] User interface 54 may include a button or keypad, lights, a
speaker for voice commands, a display, such as a liquid crystal
(LCD), light-emitting diode (LED), or organic light-emitting diode
(OLED). In some examples the display may be a touch screen. User
interface 54 may be configured to display any information related
to the delivery of stimulation therapy, such as currently selected
parameter values, intensity thresholds, or any other therapy
information. User interface 54 may also receive user input via user
interface 54. The input may be, for example, in the form of
pressing a button on a keypad or selecting an icon from a touch
screen. The input may, for example, request starting or stopping
electrical stimulation, or requesting some other change to the
delivery of electrical stimulation.
[0075] Telemetry module 56 may support wireless communication
between IMD 14 and programmer 18 under the control of processor 50.
Telemetry module 56 may also be configured to communicate with
another computing device via wireless communication techniques, or
direct communication through a wired connection. In some examples,
telemetry module 56 may be substantially similar to telemetry
module 36 of IMD 14 described herein, providing wireless
communication via an RF or proximal inductive medium. In some
examples, telemetry module 56 may include an antenna, which may
take on a variety of forms, such as an internal or external
antenna.
[0076] Examples of local wireless communication techniques that may
be employed to facilitate communication between programmer 18 and
IMD 14 include RF communication according to the 802.11 or
Bluetooth specification sets or other standard or proprietary
telemetry protocols. In this manner, other external devices may be
capable of communicating with programmer 18 without needing to
establish a secure wireless connection.
[0077] FIG. 4 is a timing diagram of an example high density
electrical stimulation signal 60 that IMD 14 may generate and
deliver to patient 12. Electrical stimulation signal 60 includes a
plurality of pulses 62A-62G (collectively, "pulses 62"). Although
seven pulses are shown in FIG. 4, stimulation signal 60 may include
any number of pulses, which may depend on the time period over
which IMD 14 delivers stimulation signal 60 to patient 12. Each
pulse 62 has an amplitude AMP.sub.A and a pulse width PW.sub.A. In
some examples, each pulse 62 of electrical stimulation signal 60
can have the same amplitude AMP.sub.A and pulse width PW.sub.A. In
other examples, at least one pulse 62 of signal 60 may have a
different amplitude AMP.sub.A and/or pulse width PW.sub.A than
another pulse 62. However, in either example, electrical
stimulation signal 60 has a duty cycle of about 5% to about 50% and
a frequency in a range of about 1 Hz to about 1400 Hz or less
(e.g., less than or equal to about 1000 Hz). In addition, in some
examples, each pulse 62 may have a pulse width PW.sub.A in a range
of about 0.1 ms to about 5 ms (e.g., less than or equal to about 1
ms, such as in a range of about 0.5 ms to about 1 ms).
[0078] The duty cycle of electrical stimulation signal 60, which
may be the on-time of electrical stimulation signal 60 per unit of
time (e.g., one second), can be characterized by a product of a
frequency and a pulse width PW.sub.A of pulses 62. For example, for
a stimulation signal 60 having a frequency of about 800 Hz and a
pulse width of about 300 microseconds (.mu.s) (0.0003 seconds),
stimulation signal 60 may have a duty cycle of about 24%,
calculated as follows:
Duty .times. Cycle = 800 .times. pulses 1 .times. sec * 0.0003 sec
1 .times. pulse = 0.24 sec .times. therapy .times. " on .times.
.times. time " 1 .times. sec .times. total .times. time = 24
.times. % ( Equation .times. 1 ) ##EQU00001##
[0079] As another example, for a stimulation signal having a
frequency of about 300 Hz and a pulse width of about 700 .mu.s,
stimulation signal 60 may have a duty cycle of about 21%,
calculated as follows:
Duty .times. Cycle = 300 .times. pulses 1 .times. sec * 0.0007 sec
1 .times. pulse = 0.21 sec .times. therapy .times. " on .times.
.times. time " 1 .times. sec .times. total .times. time = 21
.times. % ( Equation .times. 2 ) ##EQU00002##
[0080] In some examples, for a frequency of less than or equal to
about 1000 Hz, the pulse width PW.sub.A of pulses 62 can be
selected such that stimulation signal 60 has a duty cycle of about
20% to about 50%. In addition, the amplitude AMP.sub.A of
stimulation signal 60 can be selected such that the dose of
electrical stimulation signal 60 (having the desired duty cycle) is
sufficient to elicit a therapeutic response from patient 12 when
IMD 14 delivers electrical stimulation signal 60 to a target tissue
site in patient 12 (e.g., proximate spinal cord 20, a peripheral
nerve, a muscle, or another suitable tissue site, which may be
selected based on the patient condition being treated). For
example, in examples in which pulses 62 are substantially similar
(e.g., identical or nearly identical amplitudes AMP.sub.A and pulse
widths PW.sub.A), the dose of electrical stimulation signal 60 can
be determined to be a product of the amplitude AMP.sub.A and pulse
width PW.sub.A of the pulses 62A-62D, which are the pulses 62
delivered over a 0.01 second period of time. In some examples in
which IMD 14 delivers stimulation signal 60 to patient 12 to spinal
cord 20 to treat pain, stimulation signal 60 may have a duty cycle
of about 20% to about 50%, a frequency in a range of about 1 Hz to
about 1400 Hz, and pulses 62 may each have a pulse width PW.sub.A
less in a range of about 0.1 ms to about 5 ms and an amplitude
AMP.sub.A below a paresthesia threshold of patient 12.
[0081] Stimulation generator 34 of IMD 14 may generate and deliver
high duty cycle electrical stimulation signal 60 using any suitable
technique. In some examples, stimulation generator 34 may deliver
each of the pulses 62 with the same electrode combination. In some
examples, stimulation generator 34 may deliver one or more recharge
pulses (also referred to as a "recovery pulse" or a "charge
balancing pulse") after a predetermined number of pulses 62 are
delivered, the predetermined number being greater than one. Thus,
rather than charge balancing on a pulse-by-pulse basis (e.g.,
delivering one recharge pulse after each pulse 62), in some
examples, processor 30 may control stimulation generator 34 to
deliver one or more recharge pulses after delivery of two or more
pulses 62. In other examples, processor 30 may control stimulation
generator 34 to deliver pulses to promote charge balance on a
pulse-by-pulse basis.
[0082] In other examples, stimulation generator 34 may deliver
different pulses 62 via respective electrode combinations, such
that the high pulse density electrical stimulation signal is
delivered via multiple therapy programs. For example, under the
control of processor 30, stimulation generator 34 may deliver
pulses 62A, 62C, 62E, 62G with a first electrode combination, and
deliver pulses 62B, 62D, 62F with a second, different electrode
combination. In this example, pulses 62A, 62C, 62E, 62G can be part
of a first sub-signal delivered via the first electrode
combination, and pulses 62B, 62D, 62F can be part of a second
sub-signal delivered via the second electrode combination. The
first and second sub-signals, when delivered together over time
such that the pulses of the sub-signals interleaved together as
shown in FIG. 4, combine to define high duty cycle electrical
stimulation signal 60. Although two sub-signals are used here as an
example, in other examples, stimulation generator 34 of IMD 14 may
generate and deliver high duty cycle electrical stimulation signal
60 using any suitable number of sub-signals. In some examples,
stimulation generator 34 may generate each sub-signal using a
respective therapy program, which may be stored as a group in
memory 32 of IMD 14 (FIG. 2).
[0083] In some examples in which stimulation generator 34 may
deliver different pulses 62 via different electrode combinations,
processor 30 may control stimulation generator 34 may deliver one
or more recharge pulses after a predetermined number of pulses 62
are delivered, the predetermined number being greater than one. The
predetermined number of pulses 62 may include pulses generated
according to different therapy programs. Thus, in some examples,
stimulation generator 34 may deliver one or more recharge pulses
after pulses of different sub-signals are delivered. For example,
under the control of processor 30, stimulation generator 34 may
deliver one or more recharge pulses after stimulation generator
delivers pulses 62A and 62B, rather than delivering one or more
recharge pulses between pulses 62A, 62B, and then again after pulse
62B. In this example, stimulation generator 34 may wait to deliver
one or more recharge pulses until after stimulation generator
delivers pulses 62C and 62D, rather than delivering one or more
recharge pulses between pulses 62C, 62D, and then again after pulse
62B. In other examples, processor 30 may control stimulation
generator 34 to deliver recharge pulses to balance charge on a
pulse-by-pulse basis.
[0084] Stimulation generator 34 can deliver the sub-signals using
electrodes from a single lead 16A or from two or more leads 16B.
For example, under the control of processor 30, stimulation
generator 34 may deliver a first pulse 62A with electrode 24A of
lead 16A together with a housing electrode of outer housing 34 of
IMD 14 and deliver pulse 62B with electrode 24B of lead 16A
together with a housing electrode of outer housing 34. As another
example, under the control of processor 30, stimulation generator
34 may deliver a first pulse 62A with electrodes 24A, 24B of lead
16A and deliver pulse 62B with electrodes 24B, 24C of the same lead
16A. In another example, stimulation generator 34 may deliver
different pulses 62 with electrodes of different leads. Processor
30 may, for example, control stimulation generator 34 to alternate
delivery of pulses 62 between leads 16A, 16B, or control
stimulation generator 34 to otherwise deliver pulses 62 with
electrodes of each lead 16A, 16B at different times. For example,
under the control of processor 30, stimulation generator 34 may
deliver a first pulse 62A with electrodes 24A, 24B of lead 16A and
deliver pulse 62B with electrodes 26A, 26B of lead 16B.
[0085] Regardless of the number of electrode combinations with
which stimulation generator 34 delivers pulses 62, the combination
of pulses 62 may combine to define electrical stimulation signal 60
having a duty cycle in a range of about 20% to about 50% and a
frequency in a range of about 1 Hz to about 1400 Hz.
[0086] Delivery of each sub-signal by stimulation generator 34 may
generate a stimulation field within tissue of the patient, where
the stimulation field may be a volume of tissue through which the
electrical current from the delivered sub-signal propagates. The
electrode combinations with which pulses 62 are delivered and the
frequency of high duty cycle electrical stimulation signal 60 can
be selected such that the combination of pulses 62A, 62B (or any
other number of pulses 62 delivered from any suitable number of
different electrode combinations) results in stimulation fields
that overlap. The region of overlap of the stimulation fields may
be configured to target neural areas responsive to the high duty
cycle mechanisms described herein, e.g., to provide the desired
therapeutic effect. In some examples, the regions of the
stimulation fields that do not overlap may not provide any
therapeutic effect.
[0087] In some examples, processor 30 controls stimulation
generator 34 to generate and deliver pulses 62 via two or more
therapy programs, each defining a respective electrode combination.
For example, some pulses 62 may be part of a first sub-signal
defined by a first therapy program and delivered by stimulation
generator 34 via a first electrode combination, and other pulses 62
may be part of a second sub-signal defined by a second therapy
program and delivered by stimulation generator 34 via a second
electrode combination. Stimulation generator 34 may interleave
delivery of pulses of the first and second sub-signals, such that
the pulses only partially overlap in time or do not overlap in
time. Delivery of the first and second sub-signals may generate
respective stimulation fields within tissue. In some examples, the
stimulation fields, individually and when overlapping, have
stimulation intensities less than at least one of a perception
threshold or a paresthesia threshold of the patient. In addition,
in some examples, each pulse of the first and second sub-signals
has a pulse width less than or equal to about 5 milliseconds, and
stimulation generator 34 may interleave delivery of pulses of the
first and second sub-signals to deliver electrical stimulation
pulses at a frequency in a range of about 1 Hz to about 1400 Hz. In
some examples, processor 30 controls stimulation generator 34 to
deliver a recharge signal following the delivery of at least one
pulse of each of the first and second electrical sub-signals.
[0088] Delivering stimulation signal 60 as multiple sub-signals
delivered via respective electrode combinations may help reduce the
charge density at the electrode-tissue interface of particular
electrodes. In addition, delivering stimulation signal 60 via
multiple sub-signals may provide more flexibility in programming
the electrical stimulation therapy that has an intensity below the
perception or paresthesia threshold intensity level of patient 12
because the sub-signals may each have relatively low stimulation
intensities, but due to the overlap in the stimulation fields that
may result from the interleaving of the delivery of the
sub-signals, the sub-signals may be combined to provide efficacious
electrical stimulation therapy to patient 12.
[0089] In some examples in which stimulation generator 34 generates
and delivers a plurality of sub-signals in order to deliver the
electrical stimulation signal having the high duty cycle and
frequency less than or equal to about 1400 Hz described herein,
stimulation generator 34 may recharge at the end of the pulse
train, e.g., after the pulses of the plurality of sub-signals are
delivered. In other examples, stimulation generator 34 may recharge
after each delivered pulse.
[0090] FIG. 5 is a timing diagram of another example high duty
cycle electrical stimulation signal 64 that IMD 14 may generate and
deliver to patient 12. Electrical stimulation signal 64 includes a
plurality of pulses 66. Stimulation signal 64 may include any
number of pulses 66, which may depend on the duration that IMD 14
delivers stimulation signal 64 to patient 12. As with stimulation
signal 60 (FIG. 4), stimulation signal 64 may have duty cycle of
about 5% to about 50%, a frequency in a range of about 1 Hz to
about 1400 Hz. However, in contrast to stimulation signal 60, each
pulse 66 of stimulation signal 64 has a smaller pulse width
PW.sub.B and a higher amplitude AMP.sub.B than each of the pulses
62 of stimulation signal 60. The charge density of stimulation
signal 64 may be similar to (e.g., identical or nearly identical)
to stimulation signal 60, e.g., because the higher amplitude
AMP.sub.B may compensate for the decrease in energy delivery
resulting from the decrease in pulse width PW.sub.B relative to
pulses 62 of signal 60. As with amplitude AMP.sub.A, amplitude
AMP.sub.B may be less than or equal to a paresthesia or perception
threshold of patient 12. In addition, the duty cycle of signal 64
can be substantially the same as the duty cycle of signal 60 (FIG.
4), despite the smaller pulse width PW.sub.B, due at least in part
to the greater number of pulses 66 per second than signal 60.
[0091] Stimulation generator 34 of IMD 14 may generate and deliver
high duty cycle electrical stimulation signal 64 using any suitable
technique, such as those described with respect to signal 60.
[0092] As discussed above, due to potentially different mechanisms
of action, a patient may respond differently to the high duty cycle
electrical stimulation described herein, which may have a duty
cycle of about 5% to about 50% and a frequency in a range of about
1 Hz to about 1400 Hz, compared to burst electrical stimulation
techniques and high frequency electrical stimulation
techniques.
[0093] FIG. 6 is a timing diagram of an example burst electrical
stimulation signal 68, which includes a plurality of pulses 70A-70H
(collectively, "pulses 70"). Burst electrical stimulation signal 68
has fewer pulses 70 per unit of time (e.g., one second) than high
duty cycle electrical stimulation signals 60, 64 (FIGS. 4 and 5).
During a particular period of time, e.g., one second as shown in
FIG. 6, an IMD delivers a burst of pulses 70A-70D of electrical
stimulation signal 68 for a first time period 72, which is
immediately followed by a second period of time 74 during which the
IMD does not deliver any electrical stimulation, but, rather,
delivers one or more recovery pulses. Second time period 74 may be
referred to as a "recovery period." After second time period 74,
the IMD 14 may deliver another burst of pulses 70E-70H, which may
be followed by another recovery period. First and second time
periods 72, 74 may be substantially equal (e.g., equal or nearly
equal) in some examples, and different in other examples.
[0094] In contrast to burst electrical stimulation signal 68,
delivery of high duty cycle electrical stimulation signals 60, 64
by IMD 14 may provide better targeting of target tissue sites. For
a given dose, burst electrical stimulation signal 68 may result in
activation of more neural tissue (e.g., a larger volume of tissue)
than high duty cycle electrical stimulation signals 60, 64, which
may each provide electrical stimulation with a higher duty cycle
than burst electrical stimulation signal 68 and with smaller pulse
widths.
[0095] FIG. 7 is a timing diagram of an example high frequency
electrical stimulation signal 76, which includes a plurality of
pulses 78. High frequency electrical stimulation signal 76 has a
higher frequency than high duty cycle electrical stimulation
signals 60, 64 (FIGS. 4 and 5, such that signal 76 has a greater
number of pulses 78 per unit of time than high duty cycle
electrical stimulation signals 60, 64). For example, high frequency
electrical stimulation signal 76 may have a frequency of 1500 Hz to
about 100 kiloHz, or greater, whereas high duty cycle electrical
stimulation signals 60, 64 may each have a frequency less than or
equal to about 1400 Hz.
[0096] For a given duty cycle, high frequency electrical
stimulation signal 76 may result in activation of more neural
tissue than high duty cycle electrical stimulation signals 60, 64,
which have pulses 62, 66, respectively, with higher pulse widths
than pulses 78 of high frequency electrical stimulation signal 76.
The lower frequency of high duty cycle electrical stimulation
signals 60, 64 may allow for a larger therapeutic window for the
pulse amplitudes AMP.sub.A and AMP.sub.A, which may help a
clinician tailor the electrical stimulation to a particular patient
to allow for different neural mechanisms to be activated in order
to elicit a therapeutic response from the patient. The therapeutic
window for the pulse amplitudes AMP.sub.A and AMP.sub.A can be, for
example, the range of amplitude values that provide efficacious
therapy to patient 12 without resulting in undesired side
effects.
[0097] The electrical stimulation parameter values with which IMD
14 may generate and deliver the high density electrical stimulation
described herein, having a duty cycle of about 5% and about 50%, a
frequency less in a range of about 1 Hz to about 1400 Hz (e.g.,
less than or equal to about 1000 Hz), and a pulse width of about 5
ms or less, may be selected using any suitable technique. FIG. 8 is
a flow diagram of an example technique for selecting the electrical
stimulation parameter values. While FIG. 8 is described with
respect to processor 30 of IMD 14, in other examples, processor 50
of programmer 18 may perform any part of the technique described
with respect to FIG. 8, alone or in combination with processor 30
of IMD 14.
[0098] In the technique shown in FIG. 8, processor 30 determines a
paresthesia or perception threshold intensity level for patient 12
(80), e.g., using the technique described below with respect to
FIG. 9, by retrieving a stored paresthesia or perception threshold
intensity level from memory 32 (FIG. 2), or by receiving a
paresthesia or perception threshold intensity level from another
device, e.g., programmer 18. Processor 30 may, for example,
determine the paresthesia threshold (80), determine the perception
threshold (80), determine the lower of the paresthesia threshold
intensity level or the perception threshold intensity level for
patient 12 (80), or determine the higher of the paresthesia
threshold intensity level or the perception threshold intensity
level for patient 12.
[0099] A paresthesia threshold intensity level may be a lowest
determined electrical stimulation intensity level at which patient
12 first perceives paresthesia from the electrical stimulation
delivered by IMD 14. A perception threshold intensity level may be
a lowest determined electrical stimulation intensity level at which
patient 12 first perceives the electrical stimulation delivered by
IMD 14. In some cases, depending on the patient and/or the target
electrical stimulation site within the patient, the patient may
first perceive the electrical stimulation delivered by IMD 14 as
paresthesia. Thus, in some cases, the perception threshold
intensity level may be substantially the same (e.g., identical or
nearly identical) as the paresthesia threshold intensity level. In
other cases, however, a patient may first perceive the electrical
stimulation as a sensation different than paresthesia. Thus, some
cases, the perception threshold intensity level may be different
than the paresthesia threshold intensity level. In these examples,
a clinician may program IMD 14 and/or programmer 18 to use either
the perception or paresthesia threshold intensity levels to select
the electrical stimulation parameter with the technique shown in
FIG. 8.
[0100] After determining one or both of the paresthesia threshold
intensity level or the perception threshold intensity level,
processor 30 may determine a strength-duration curve based on the
determined one or both of the paresthesia or perception threshold
intensity level and one or more selected electrical stimulation
signal frequencies (82). A strength-duration curve may describe the
relationship between a strength of electrical stimulation and
duration, e.g., for a particular physiological response, such as a
response below the paresthesia or perception threshold of patient
12. The strength of electrical stimulation may be a function of,
for example, any one or more of the voltage or current amplitude
value of the stimulation signal, frequency of stimulation signals,
signal duration (e.g., pulse width in the case of stimulation
pulses), duty cycle, and the like.
[0101] An example of a strength duration curve is an
amplitude-pulse width curve. The amplitude-pulse width curve may
reflect, for a selected stimulation frequency, different
combinations of amplitude and pulse width values that contribute to
a stimulation field in a substantially similar manner. For example,
the amplitude-pulse width curve may indicate that a first
electrical stimulation signal with a first amplitude and a first
pulse width, and a second electrical stimulation signal having a
higher amplitude pulse with a shorter pulse width (i.e., shorter
than the first pulse width) may both provide electrical stimulation
therapy below the paresthesia or perception threshold of patient
12. Each position on the amplitude-pulse width curve, or each
position within a particular range of positions along the
amplitude-pulse width curve, may result in a substantially similar
stimulation energy when the other therapy parameter values, such as
a frequency, remain substantially constant (e.g., the other therapy
parameter values may remain within a particular range of therapy
parameter values, such as within a 10% window or less from the
values defined by the therapy program). Thus, for a given
stimulation frequency, the amplitude-pulse width curve may define,
e.g., via the amplitude-pulse width combinations associated with
the area under the curve and/or along the curve, the amplitude and
pulse width combinations that provide electrical stimulation
therapy having an intensity level below the paresthesia or
perception threshold intensity level of patient 12.
[0102] For a given frequency (e.g., in a range of about 1 Hz to
about 1000 Hz), based on the strength-duration curve, processor 30
may determine the pulse width and amplitude combination that
provides efficacious electrical stimulation therapy to patient 12
and also has a stimulation intensity below the paresthesia or
perception threshold of patient 12 (84). Processor 30 may,
automatically or in response to user input provided via programmer
18, control stimulation generator 34 to generate and deliver
electrical stimulation therapy to patient 12 with the frequency
associated with the strength-duration curve, a selected combination
of electrodes 24, 26, and a plurality of pulse width and amplitude
combinations along the strength-duration curve or below the
amplitude-pulse width curve. Processor 30 may determine whether any
of the selected pulse width and amplitude combinations provides
efficacious electrical stimulation therapy for patient 12, e.g.,
based on patient 12 input or input from another entity received via
programmer 18, based on input from a sensing module of IMD 14 or a
separate sensing module, or any combination thereof. Processor 30
may generate one or more therapy programs based on the one or more
pulse width and amplitude combinations that provide efficacious
electrical stimulation therapy to patient 12, together with the
selected frequency and electrode combination (86).
[0103] In some examples in which stimulation generator 34 generates
and delivers the high duty cycle electrical stimulation therapy via
a plurality of sub-signals delivered via respective electrode
combinations, processor 30 may determine a strength-duration curve
for each electrode combination. Thus, for each electrode
combination, the respective strength-duration curve may indicate a
plurality of combinations of electrical stimulation parameters
(e.g., amplitude and pulse width for a given frequency) that
provide a charge per pulse below the paresthesia or perception
threshold of patient 12. Based on the strength-duration curves,
processor 30, alone or based on input from a clinician, may
determine, for each of the electrode combinations, one or more
therapy programs that provide a relatively high charge per pulse
(e.g., the relatively highest charge per pulse that remains at or
below the paresthesia or perception threshold of patient 12). Each
therapy program may define a sub-signal. Processor 30, alone or
based on input from a clinician, may then determine a frequency to
interleave the two or more sub-signals.
[0104] In some examples, to determine the therapy programs,
processor 30 may determine one or more test therapy programs that
define relatively wide pulse widths and relatively low frequencies
of the sub-signals, control stimulation generator 34 to generate
and deliver electrical stimulation to patient 12 according to the
test therapy programs, and, if the delivered electrical stimulation
therapy is not sufficiently efficacious, processor 30 may modify
one or more of the test therapy programs until the electrical
stimulation provides efficacious stimulation therapy for patient
12. The efficacy of the electrical stimulation therapy can be based
on input from patient 12, from one or more sensed physiological
parameters, or any combination thereof. Processor 30 may modify one
or more of the test therapy programs by, for example, incrementally
narrowing the pulse width (e.g., by a predetermined increment)
and/or incrementally increasing the frequency (e.g., by a
predetermined increment).
[0105] Processor 30 may store the one or more therapy programs 40
in memory 32 of IMD 12 or a memory of another device for later
delivery of electrical stimulation therapy to patient 12 (86).
Processor 30 may control stimulation generator 34 to generate and
deliver electrical stimulation therapy to patient 12 in accordance
with the one or more therapy programs 40.
[0106] In some cases, therapeutic efficacy of electrical
stimulation therapy delivered by IMD 14 may change as the patient
posture state (e.g., a particular patient posture or a combination
of posture and activity) changes. Efficacy may refer to a
combination of complete or partial alleviation of symptoms alone,
or in combination with no side effects or an acceptable or
tolerable degree of undesirable side effects. In some examples,
processor 30 of IMD 14 may be configured to adjust one or more
therapy parameter values based on different postures and/or
activities engaged by patient 12 to maintain effective therapy,
e.g., by selecting select different therapy programs based on a
posture state of patient 12. In these examples, processor 30 may
determine the paresthesia or perception threshold of patient 12 for
each of a plurality of different posture states and determine one
or more therapy programs 40 for each of the posture states using
the technique shown in FIG. 8 based on the respective paresthesia
or perception threshold.
[0107] FIG. 9 is a flow diagram of an example technique by which
processor 30 of IMD 14 can determine at least one of the perception
or paresthesia threshold intensity level for patient 12. In some
examples, processor 30 is configured to determine the perception
threshold intensity level, while in other examples, processor 30 is
configured to determine the paresthesia threshold intensity level
or both the perception and paresthesia threshold intensity
level.
[0108] The perception or paresthesia threshold intensity level can
be patient-specific, as well as specific to a target tissue site
within patient 12. Thus, a perception or paresthesia threshold
intensity level can be determined for each target tissue site to
which IMD 14 delivers stimulation therapy. In some examples,
processor 30 of programmer 18 may implement the technique
illustrated in FIG. 9 automatically, e.g., without user
intervention or control after initiating the technique. In other
examples, processor 30 may implement the technique illustrated in
FIG. 9 under control of a user, such as a clinician, who controls
processor 30 via programmer 18. While FIG. 9 is described with
respect to processor 30 of IMD 14, in other examples, processor 50
of programmer 18 may perform any part of the technique described
with respect to FIG. 9, alone or in combination with processor 30
of IMD 14.
[0109] In accordance with the technique shown in FIG. 9, processor
30 sets stimulation parameter values such that the stimulation
parameter values define a relatively low stimulation intensity,
e.g., an intensity below an expected perception or paresthesia
threshold intensity (90). The initial stimulation parameter values
may be selected by a clinician in some examples. In some examples
in which processor 30 controls stimulation generator 34 to generate
and deliver stimulation to patient 12 in the form of electrical
pulses, the stimulation parameters include at least one of a
voltage or current amplitude, a pulse width, a pulse rate, or a
duty cycle. In examples in which processor 30 controls stimulation
generator 34 to deliver stimulation to patient 12 in the form of a
continuous waveform, the stimulation parameters include at least
one of a voltage amplitude, a current amplitude, a frequency, a
waveform shape, or a duty cycle.
[0110] In either case, processor 30 sets the stimulation parameters
to respective values to define a stimulation intensity, and
controls stimulation generator 34 to deliver stimulation to patient
12 at the set stimulation intensity (defined by the selected
stimulation parameter values) (92). During therapy delivery or
after stimulation generator 34 delivers stimulation to patient 12,
processor 30 determines whether patient 12, a clinician, or patient
caretaker has provided input indicating patient 12 has perceived
the electrical stimulation or indicating paresthesia resulted from
the electrical stimulation (94). Patient 12, the clinician, or
patient caretaker can provide the input, e.g., via user interface
54 of programmer 18 or directly via IMD 14. For example, a motion
sensor can be integrated into or on a housing of IMD 14, and the
motion sensor can be configured to generate a signal that is
indicative of patient 12 tapping IMD 14 through the skin. The
number, rate, or pattern of taps may be associated with the input
indicative of stimulation perception or paresthesia, and processor
30 may identify the tapping by patient 12 to determine when patient
input is received. When the input is received via user interface 54
of programmer 18, processor 50 of programmer 18 may transmit a
signal indicative of the input to IMD 14 via the respective
telemetry modules 56, 36.
[0111] When processor 30 has not received an indication of the
input indicative of the stimulation perception or paresthesia
within a predetermined time period during or immediately after
delivery of the stimulation according to the selected stimulation
intensity ("NO" branch of block 94), processor 30 again sets the
stimulation intensity, e.g., by adjusting at least one stimulation
parameter value to increase a stimulation intensity of the
stimulation signal (90). For example, processor 30 may increase a
voltage amplitude or a current amplitude to increase the
stimulation intensity. In some examples, processor 30 changes a
value of only one of the stimulation parameters while the remaining
parameters are kept approximately constant. The stimulation
parameter that is selected may be known to affect stimulation
intensity. In other examples, processor 30 may adjust a combination
of two or more stimulation parameters to increase stimulation
intensity.
[0112] After modifying the one or more stimulation parameter
values, processor 30 controls stimulation generator 34 to deliver
stimulation to patient 12 using the newly defined stimulation
parameter values (92). In this way, processor 30 can implement an
iterative procedure to determine the perception or paresthesia
threshold intensity for patient 12, and, in some examples, for a
specific target tissue site within patient 12.
[0113] In response to not receiving input indicative of patient
perception or paresthesia is received within a predetermined time
period during or immediately after delivery of the stimulation
according to the selected stimulation intensity ("NO" branch of
block 94), processor 30 may again adjust at least one stimulation
parameter value to increase a stimulation intensity of the
stimulation signal (90). This process may repeat until processor 30
receives input indicative of patient perception or paresthesia
within a predetermined time period during or immediately after
delivery of the stimulation according to the selected stimulation
intensity. In response to receiving the input ("YES" branch of
block 94), processor 30 may store the stimulation intensity level
as the patient perception threshold intensity level and/or
paresthesia threshold intensity level (depending on the whether the
response indicates patient perception of the electrical stimulation
or resulting paresthesia, respectively) in memory 32 of IMD 14
(FIG. 2) or in another memory (e.g., memory 52 of programmer 18)
(96).
[0114] In addition, processor 30 may define stimulation parameter
values for the therapy programs 40 (FIG. 2) for providing the high
duty cycle electrical stimulation techniques described herein based
on the determined patient perception threshold intensity level
and/or paresthesia threshold intensity level, e.g., using the
technique described with respect to FIG. 8. For example, processor
may define stimulation parameter values for the therapy programs 40
(FIG. 2) that result in a stimulation intensity level less than or
equal to one or both of the patient perception threshold intensity
level or paresthesia threshold intensity level.
[0115] While the techniques described above are primarily described
as being performed by processor 30 of IMD 14 or processor 50 of
programmer 18, in other examples, one or more other processors may
perform any part of the techniques described herein alone or in
addition to processor 30 or processor 50. Thus, reference to "a
processor" may refer to "one or more processors." Likewise, "one or
more processors" may refer to a single processor or multiple
processors in different examples.
[0116] The techniques described in this disclosure, including those
attributed to IMD 14, programmer 18, or various constituent
components, may be implemented, at least in part, in hardware,
software, firmware or any combination thereof. For example, various
aspects of the techniques may be implemented within one or more
processors, including one or more microprocessors, DSPs, ASICs,
FPGAs, or any other equivalent integrated or discrete logic
circuitry, as well as any combinations of such components, embodied
in programmers, such as clinician or patient programmers, medical
devices, or other devices.
[0117] In one or more examples, the functions described in this
disclosure may be implemented in hardware, software, firmware, or
any combination thereof. If implemented in software, the functions
may be stored on, as one or more instructions or code, a
computer-readable medium and executed by a hardware-based
processing unit. Computer-readable media may include
computer-readable storage media forming a tangible, non-transitory
medium. Instructions may be executed by one or more processors,
such as one or more DSPs, ASICs, FPGAs, general purpose
microprocessors, or other equivalent integrated or discrete logic
circuitry. Accordingly, the term "processor," as used herein may
refer to one or more of any of the foregoing structure or any other
structure suitable for implementation of the techniques described
herein.
[0118] In addition, in some aspects, the functionality described
herein may be provided within dedicated hardware and/or software
modules. Depiction of different features as modules or units is
intended to highlight different functional aspects and does not
necessarily imply that such modules or units must be realized by
separate hardware or software components. Rather, functionality
associated with one or more modules or units may be performed by
separate hardware or software components, or integrated within
common or separate hardware or software components. Also, the
techniques could be fully implemented in one or more circuits or
logic elements. The techniques of this disclosure may be
implemented in a wide variety of devices or apparatuses, including
an IMD, an external programmer, a combination of an IMD and
external programmer, an integrated circuit (IC) or a set of ICs,
and/or discrete electrical circuitry, residing in an IMD and/or
external programmer.
[0119] Various aspects of the disclosure have been described. These
and other aspects are within the scope of the following claims.
* * * * *